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EPA-HQ-OPP-2002-0202-0016 | Supporting & Related Material | "2002-08-14T04:00:00" | null | UNITED
STATES
ENVIRONMENTAL
PROTECTION
AGENCY
WASHINGTON,
D.
C.
20460
OFFICE
OF
PREVENTION,
PESTICIDES
AND
TOXIC
SUBSTANCES
MEMORANDUM
SUBJECT:
Lindane
Food
Chain
Bio
Accumulation,
Magnification
and
Concentration
PC
Code
No.
009001;
Case
No.
818566;
DP
Barcode:
D283666
TO:
B.
Shackleford,
Branch
Chief
M.
Howard,
Team
Leader
Special
Review
and
Reregistration
Division
(7508C)
FROM:
ERB
V
RED
Team
for
Lindane:
N.
E.
Federoff,
Wildlife
Biologist,
Ecological
Effects
Reviewer,
Team
Leader
F.
A
Khan,
Ph.
D.,
Environmental
Scientist
Environmental
Fate
and
Effects
Division
(7507C)
THROUGH:
Mah
T.
Shamim,
Ph.
D.,
Chief
Environmental
Risk
Branch
V
EFED
(7507C)
Lindane
Food
Chain
Bio
Accumulation,
Magnification
and
Concentration
Due
to
extensive
use
over
the
past
50
years,
lindane
is
present
in
most
environmental
media
and
biological
compartments
and
is
present
in
terrestrial
and
aquatic
food
chains.
However,
evidence
suggests
that
concentrations
have
been
gradually
decreasing.
Recent
data
suggest
that
the
declines
of
HCH
isomer
concentrations
in
the
environment
have
resulted
from
reduced
use
of
technical
HCH,
especially
in
Asian
countries
(Iwata
et
al.,
1993).
The
behavior
of
HCH
isomers
in
the
environment
is
complex
because
they
are
multimedia
chemicals,
existing
and
exchanging
among
different
compartments
of
the
environment
such
as
atmosphere,
surface
water,
soil
and
sediment.
In
addition,
temperature,
humidity,
and
other
environmental
properties,
may
have
significant
influence
on
environmental
degradation
rates.
The
most
common
isomers
found
in
the
environment
are
lindane
(
),
,
and
HCHs,
with
HCH
as
the
predominant
isomer
in
air
and
ocean
water
and
HCH
the
predominant
isomer
in
soils,
animal
tissues
and
fluids
(Willett
et
al.,
1998).
The
physical
and
chemical
properties
of
the
HCH
isomers
can
be
quite
different
from
one
another.
For
example,
HCH
has
a
lower
vapor
pressure
and
a
higher
bio
concentration
factor
in
fat
than
either
HCH
or
lindane.
In
contrast,
lindane
and
HCH
seem
to
be
more
volatile
than
HCH
(Willett
et
al.,
1998).
These
properties
likely
reflect
some
of
the
differences
seen
in
HCH
isomer
persistence
and
variability
in
bio
magnification,
concentration
and
accumulation
in
the
various
biological
compartments.
Differences
in
accumulation
are
also
likely
due
to
different
modes
of
uptake,
metabolism
and
sources
of
contamination.
Bio
concentration
factors
(BCF)
for
Lindane
were
780x
in
fillet,
2500x
in
viscera
and
1400x
in
whole
fish.
It
would
seem
this
is
partly
due
to
high
lipid
solubility.
Lindane
can
become
enriched
in
lipid
containing
biological
compartments.
However,
although
lindane
may
bioconcentrate
rapidly,
most
data
suggest
bio
transformation,
depuration
and
elimination
are
relatively
rapid
once
exposure
is
eliminated.
After
a
28
day
exposure
and
14
days
of
depuration,
levels
were
reduced
by
96%,
95%
and
85%
in
fillet,
viscera
and
in
whole
fish,
respectively.
HCH
bio
accumulation/
food
chain
data
from
Russia
(Moisey
et
al
2001)
and
from
Central/
Western
Canada
(Kelly
and
Gobas
2001)
suggests
that
HCH
does
bio
accumulate/
biomagnify
alpha
does
also,
but
at
a
lower
level,
and
gamma
(Lindane)
the
least.
Data
from
Moisey
et
al
(2001)
suggests
that
the
relative
proportions
of
HCH
isomers
varied
dramatically
across
species
in
the
arctic
marine
food
web
studied.
Kelly
and
Gobas
(2001)
indicate
that
the
fugacity
of
lindane
decreases
with
increasing
trophic
level
suggesting
trophic
dilution
(the
lichen
caribouwolf
food
chain
was
studied).
It
appears
that
upper
trophic
level
mammals
may
be
able
to
efficiently
eliminate
lindane
and
to
a
smaller
extent
HCH,
but
not
HCH.
In
birds,
HCH
seems
to
have
a
tendency
to
accumulate
to
a
greater
extent
than
the
other
isomers,
which
may
be
due
to
consuming
contaminated
prey
(Elliot
et
al.,
1989),
although
concentrations
have
been
on
the
decline.
Even
though
concentrations
of
HCH
isomers
were
detected
in
surface
waters
of
the
Arctic,
bioaccumulation
in
the
aquatic
food
chains
was
significantly
less
than
the
other
organochlorine
compounds
(Norstrom
and
Muir,
1994)
analyzed.
In
conclusion,
although
there
is
evidence
that
HCH
isomers
can
and
do
bio
magnify,
bioconcentrate
and
bio
accumulate
in
different
biological
compartments
and
at
different
rates,
the
overall
magnitude
is
an
uncertainty.
Overall,
lindane
seems
to
accumulate
environmentally
but
generally
to
a
lesser
extent
than
either
the
alpha,
and
especially,
the
beta
isomers.
Generally,
Lindane
tends
to
bio
magnify
in
lower
trophic
levels
where
bio
transformation
was
minimal,
although
not
to
the
extent
HCH
does.
HCH
tends
to
mainly
bio
accumulate
in
upper
trophic
levels
(fish,
birds,
mammals)
at
higher
concentrations.
Literature
Cited
Elliot,
J.
E.,
D.
G.
Noble
and
R.
J.
Norstrom.
1989.
Organochlorine
contaminants
in
seabird
eggs
from
the
Pacific
coast
of
Canada,
1971
1986.
Environmental
Monitoring
and
Assessment
12:
67
82.
Iwata,
H.,
S.
Tanabe,
N.
Sakai
and
R.
Tatsukawa.
1993.
Distribution
of
persistent
organochlorines
in
the
oceanic
air
and
surface
seawater
and
the
role
of
ocean
on
their
global
transport
and
fate.
Environmental
Science
and
Technology
27:
1080
1098.
Kelly,
B.
and
F.
Gobas.
2001.
Bioaccumulation
of
POPs
in
lichen
caribou
wolf
food
chains
of
Canada's
Central
and
Western
Arctic.
Environmental
Science
and
Technology
35(
2):
325
334.
Moisey,
J.,
A.
Fisk,
K.
Hobson
and
R.
Norstrom.
2001.
Hexachlorocyclohexane
(HCH)
isomers
and
chiral
signatures
of
alpha
HCH
in
Arctic
marine
food
web
of
the
Northwater
Polynya.
Environmental
Science
and
Technology
35(
10):
1920
1927.
Norstrom,
R.
J.,
and
D.
C.
G.
Muir.
1994.
Chlorinated
hydrocarbon
contaminants
in
arctic
marine
mammals.
Sci
Total
Environ.
154:
107
128.
Willet,
K.,
E.
M.
Ulrich
and
R.
A.
Hites.
1998.
Differential
toxicity
and
environmental
fates
of
hexachlorocyclohexane
isomers.
Environmental
Science
and
Technology
32
(15):
2197
2207.
| epa | 2024-06-07T20:31:43.173819 | regulations | {
"license": "Public Domain",
"url": "https://downloads.regulations.gov/EPA-HQ-OPP-2002-0202-0016/content.txt"
} |
EPA-HQ-OPP-2002-0202-0017 | Supporting & Related Material | "2002-08-14T04:00:00" | null | PC
Code:
009001
DP
Code:
D282004
MEMORANDUM
DATE:
April
25,
2002
SUBJECT:
Estimated
Concentrations
of
Lindane
in
Surface
Water
Used
as
a
Source
of
Drinking
Water
From
Use
and
Disposal
of
Shampoo
and
Lotion
Into
Household
Wastewater
TO:
Betty
Shackleford,
Branch
Chief
M.
Howard,
Team
Leader
Reregistration
Branch
III
Special
Review
and
Reregistration
Division
(7508C)
FROM:
Faruque
A.
Khan,
Ph.
D.,
Environmental
Scientist
Environmental
Fate
and
Effects
Division
(7507C)
THROUGH:
Mah
T.
Shamim,
Ph.
D.,
Chief
Jean
Holmes,
DMV,
MPH,
RAPL
Environmental
Risk
Branch
V
Environmental
Fate
and
Effects
Division
(7507C)
Exposure
Conclusions
This
memo
presents
the
screening
estimated
concentrations
of
lindane
in
surface
water
used
as
a
source
of
drinking
water
from
consumer
use
for
both
lice
and
scabies
treatments.
Surface
water
concentrations
were
based
on
the
estimated
annual
production
volume
directed
to
this
market
and
released
into
household
wastewater
from
products
containing
lindane
at
a
maximum
concentration
of
1
percent.
Exposures
are
further
based
on
the
effects
of
treatment
in
a
Publically
Owned
Treatment
Works
(POTW)
with
a
minimum
of
secondary
treatment
using
either
trickling
filter
or
activated
sludge
bioreactors.
Both
daily
per
capita
release
into
the
waste
stream
and
the
daily
per
capita
wastewater
volume
release
are
used
in
estimating
time
averaged
surface
water
concentrations.
Estimated
surface
water
concentrations
are,
acute
4.
41E
04
µg
L
based
on
a
high
end
stream
dilution
factor
(i.
e.,
upper
10
th
percentile)
and
chronic
3.
4E
05
µg
L
based
on
the
median
stream
dilution
factor
(i.
e.,
50
th
percentile),
Table
1.
Table
1.
Recommended
Lindane
Surface
Water
Drinking
Water
Concentrations
from
Household
Releases.
Exposure
Estimated
Drinking
Water
Concentrations
(µg
L
1
)
Acute
4.
41E
04
Cancer
Chronic
3.
40E
05
Note:
µg
L
1
=
ppb
Approach
to
Exposure
Assessment
The
EFED
does
not
possess
a
method
nor
has
it
traditionally
conducted
exposure
assessments
for
the
released
of
pesticides
to
domestic
wastewater
from
consumer
uses.
Therefore,
EFED
obtained
and
relied
on
the
Office
of
Pollution
Prevention
and
Toxics'(
OPPT)
consumer
exposure
model,
Exposure
and
Fate
Assessment
Screening
Tool
(E
FAST)
(Versar,
1999)
to
estimate
Lindane
concentrations
in
surface
water.
Specifically,
EFED
used
the
program's
submodel
designed
for
releases
to
domestic
wastewater
treatment,
often
referred
to
as
Down
the
Drain
Releases.
The
method
assumes
that
in
a
given
year
the
entire
production
volume
is
parceled
out
on
a
daily
basis
to
the
U.
S.
population
and
converted
to
a
mass
release
per
capita;
daily
per
capita
release
of
lindane
to
a
wastewater
treatment
facility
(gm/
person/
day).
This
mass
is
then
diluted
into
the
average
daily
volume
of
wastewater
released
per
person
daily
to
arrive
at
an
estimated
concentration
of
lindane
in
wastewater
prior
to
entering
a
treatment
facility.
Lindane
concentration
in
untreated
wastewater
is
then
reduced
by
the
fraction
removed
during
wastewater
treatment
processes
before
release
into
a
river
or
stream.
Estimating
lindane
removal
from
wastewater
treatment
is
accomplished
through
the
use
of
basic
physical
chemical
properties
estimated
to
structure
activity
relationships
(SAR)
and
a
POTWsimulation
model.
OPPT's
Estimation
Program
Interface
(EPI)
(SRC,
2000)
which
contains
as
part
of
its
subroutines
a
POTW
simulation
model
was
used
for
this
purpose.
After
estimating
removal
in
wastewater
treatment
the
remaining
pesticide
is
discharged
and
instantaneously
diluted
into
surface
water
where
no
further
removal
occurs.
Stream
dilution,
referred
to
as
Stream
Dilution
Factor,
is
equal
to
the
volume
of
receiving
stream
flow
under
specific
flow
conditions
divided
by
the
volume
of
wastewater
released
from
the
POTW.
The
resulting
concentration
is
then
used
for
estimating
drinking
water
concentrations
in
the
human
health
risk
assessment.
Exposure
Assessment
and
Results
Estimating
Household
Wastewater
Releases
Production
volume
of
Lindane
marketed
as
consumer
use
was
based
on
unpublished
marketing
data
from
the
U.
S.
Food
and
Drug
Administration.
Data
were
masked,
redacted,
to
preserve
the
unintended
release
of
potentially
sensitive
information.
Estimates
were
based
on
concentrations
of
lindane
in
head
lice
and
scabies
treatment
products,
not
to
exceed
1%
of
formulation.
Based
on
available
information,
this
concentration
equates
to
approximately
10
mg
lindane
per
ml
of
product.
Available,
but
sensitive,
marketing
data
indicated
that
approximately
1914.6
Kg
of
lindane
was
marketed
to
consumers
for
use
in
head
lice
and
scabies
treatment
in
the
U.
S.
during
1999
2000.
This
estimate
was
used
in
assessing
potential
exposures
from
this
use
pattern.
The
U.
S.
population
is
set
at
2.727
x
10
8
(Versar,
1999).
Using
the
formula
below,
the
estimated
daily
per
capita
household
wastewater
release
of
lindane
is
1.92E
05
gm/
person/
day.
Equation.
1.
0
H
PdVol
Pop
x
x
R
=
1000grams
1Kg
1Year
365Days
Where:
HR
=
Daily
per
capita
release
of
the
chemical
to
a
wastewater
treatment
facility
(grams/
person/
day)
PdVol
=
Production
volume
(1914.6
Kg/
year)
Pop
=
U.
S.
Population
(The
U.
S.
Census
Bureau
(1999)
estimates
the
total
U.
S.
population
to
be
2.
727
x
10
8
persons)
Estimated
Surface
Water
Concentrations
The
estimated
time
averaged
surface
water
concentration
of
Lindane
that
may
result
from
household
release
to
wastewater
treatment
can
be
estimated
by
the
following
equation:
Equation.
2.
0
C
H
x
Q
x
WWTxCFI
SDF
SM
R
H
M
=
1
1
()
Equation.
3.
0
C
H
x
Q
x
WWTxCFI
SDF
SH
R
H
L
=
1
1
()
Where:
CSM
=
Median
time
averaged
surface
water
concentration
µg/
L
CSH
=
High
end
time
average
surface
water
concentration
µg/
L
HR
=
Daily
per
capita
release
of
chemical
(i.
e.
pre
treatment
release)
QH
=
Daily
per
capita
wastewater
volume
released
(364
L/
person/
day)
(U.
S.
EPA,
1990;
Versar,
1992)
WWT
=
Fraction
of
chemical
removed
during
wastewater
treatment
(36.98%)
SDFM
=50
th
percentile
stream
dilution
factor
for
streams
to
which
wastewater
facilities
discharge
(980.69)
(Versar,
1992)
SDFL
=10
th
percentile
stream
dilution
factor
for
streams
to
which
wastewater
facilities
discharge
(75.
44)
(Versar,
1992)
CFI
=
Conversion
factor
(1x10
6
µg/
gram)
Each
of
the
above
factors
and
assumptions
are
discussed
below.
Daily
pretreated
release,
HR
,
is
discussed
above.
Household
wastewate
volume,
QH,
was
obtained
from
the
1990
NEEDS
database
of
data
on
wastewater
flow.
The
statistics
used
were
derived
from
a
subset
of
the
NEEDS
database
for
POTWs
with
domestic
flow
and
a
reported
population
served.
The
subset
was
further
restricted
by
deleting
all
facilities
that
had
wastewater
flow
greater
than
facility
total
flow
and
records
that
were
above
the
95
th
percentile,
assumed
to
be
outliers,
of
885
liters
per
capita
per
day.
Wastewater
flow
statistics
were
provided
by
flow
category
for
all
records
selected.
The
household
wastewater
flow
of
364
liters/
person/
day
was
the
50th
percentile.
Fraction
of
chemical
removed,
WWT,
is
discussed
above.
A
copy
of
the
EPA
SAR
assessment
can
be
found
in
Appendix
A.
The
stream
dilution
factor,
SDFM
and
SDFL
is
equal
to
the
volume
of
the
receiving
stream
or
river
under
mean
flow
conditions
divided
by
the
volume
of
wastewater
released
from
the
treatment
facility.
SDF
were
calculated
for
all
active
wastewater
treatment
facilities
reported
in
the
U.
S.
EPA
STORET
Industrial
Facility
Database
(IFD)
using
the
stream
dilution
factor
program
(Versar,
1999).
For
this
purpose,
facilities
with
SDFs
of
1.
0
and
less
are
deleted
because
wastewater
flow
dominates
stream
flow
and
is
unlikely
to
be
a
local
source
of
drinking
water.
Therefore
the
statistical
distribution
of
SDFs
is
based
on
POTWs
with
SDFs
greater
than
1.
0
(9,
085
total
facilities).
Mean
SDFs
for
the
10
th
and
50
th
percentile
treatment
facility
are
recommended
for
use
in
acute
and
chronic
risk
assessments.
Table
2
provides
the
model
inputs
used
to
estimate
surface
water
concentrations
of
lindane
from
consumer
use.
Appendix
B
provides
model
results.
Table
2.
E
FAST
Input
Parameters
for
Lindane
Parameters
and
Units
Lindane
Source
PC
Code
1090001
Production
volume
(Kg/
Year)
for
2000
2001
1914.6
Unpublished
FDA
data
Removal
in
waste
water
treatment
(%)
36.98
http://
www.
epa.
gov/
oppt/
ex
posure/
docs/
episuitedl.
htm
The
theoretical
basis
and
the
program
for
estimating
environmental
releases
of
chemicals
in
household
products
and
the
referenced
equations
can
be
found
in
the
E
FAST
manual
located
(http://
www.
epa.
gov/
opptintr/
exposure/
docs/
efast.
htm).
References
SRC,
2000.
Estimation
Program
Interface,
Version
3.
10.
Prepared
for:
U.
S.
Environmental
Protection
Agency,
Office
of
Pollution
Prevention
and
Toxics,
Exposure
Assessment
Branch.
William
Meyland
and
Philip
Howard,
Syracuse
Research
Corporation,
Syracuse,
NY.
Versar,
Inc.
1999.
Exposure
and
Fate
Assessment
Screening
Tool
(E
FAST),
Beta
Version,
Documentation
Manual,
December
31,
1999.
Prepared
for:
U.
S.
Environmental
Protection
Agency,
Office
of
Pollution
Prevention
and
Toxics,
Exposure
Assessment
Branch.
Versar,
Inc.
Springfield
Va.
Contract
No.
68
W
99
041.
Appendix
A
SMILES
:
C(
C(
C(
C(
C1CL)
CL)
CL)
CL)(
C1CL)
CL
CHEM
:
gamma
Hexachlorocyclohexane
CAS
NUM:
000058
89
9
MOL
FOR:
C6
H6
CL6
MOL
WT
:
290.83
EPI
SUMMARY
(v3.10)
Physical
Property
Inputs:
Water
Solubility
(mg/
L):
Vapor
Pressure
(mm
Hg)
:
Henry
LC
(atm
m3/
mole)
:
Log
Kow
(octanol
water):
Boiling
Point
(deg
C)
:
Melting
Point
(deg
C)
:
Log
Octanol
Water
Partition
Coef
(SRC):
Log
Kow
(KOWWIN
v1.66
estimate)
=
4.26
Log
Kow
(Exper.
database
match)
=
3.72
Exper.
Ref:
Hansch,
C
et
al.
(1995)
Log
Kow
(Exper.
database
match)
=
3.80
Exper.
Ref:
Hansch,
C
et
al.
(1995)
Log
Kow
(Exper.
database
match)
=
3.78
Exper.
Ref:
Hansch,
C
et
al.
(1995)
Log
Kow
(Exper.
database
match)
=
4.14
Exper.
Ref:
Hansch,
C
et
al.
(1995)
Boiling
Pt,
Melting
Pt,
Vapor
Pressure
Estimations
(MPBPWIN
v1.40):
Boiling
Pt
(deg
C):
304.35
(Adapted
Stein
&
Brown
method)
Melting
Pt
(deg
C):
56.98
(Mean
or
Weighted
MP)
VP(
mm
Hg,
25
deg
C):
0.000506
(Modified
Grain
method)
MP
(exp
database):
112.5
deg
C
BP
(exp
database):
60
@
0.34
mm
Hg
deg
C
VP
(exp
database):
3.52E
05
mm
Hg
at
25
deg
C
Water
Solubility
Estimate
from
Log
Kow
(WSKOW
v1.40):
Water
Solubility
at
25
deg
C
(mg/
L):
4.044
log
Kow
used:
4.14
(expkow
database)
no
melting
pt
equation
used
Water
Sol
(Exper.
database
match)
=
7.3
mg/
L
(25
deg
C)
Exper.
Ref:
RICHARDSON,
LT
&
MILLER,
DM
(1960)
Water
Sol
(Exper.
database
match)
=
2
mg/
L
(25
deg
C)
Exper.
Ref:
WEIL,
L
ET
AL.
(1974)
Water
Sol
(Exper.
database
match)
=
0.24
mg/
L
(25
deg
C)
Exper.
Ref:
WEIL,
L
ET
AL.
(1974)
Water
Sol
(Exper.
database
match)
=
10
mg/
L
(20
deg
C)
Exper.
Ref:
SHIU,
WY
ET
AL
(1990)
Water
Sol
(Exper.
database
match)
=
8
mg/
L
(25
deg
C)
Exper.
Ref:
CHEM
INSPECT
TEST
INST
(1992)
ECOSAR
Class
Program
(ECOSAR
v0.99g):
Class(
es)
found:
Neutral
Organics
Henrys
Law
Constant
(25
deg
C)
[HENRYWIN
v3.10]:
Bond
Method
:
2.56E
004
atm
m3/
mole
Group
Method:
4.25E
011
atm
m3/
mole
Exper
Database:
5.14E
06
atm
m3/
mole
Henrys
LC
[VP/
WSol
estimate
using
EPI
values]:
4.788E
005
atm
m3/
mole
Probability
of
Rapid
Biodegradation
(BIOWIN
v4.00):
Linear
Model
:
0.0593
Non
Linear
Model
:
0.0000
Expert
Survey
Biodegradation
Results:
Ultimate
Survey
Model:
1.5174
(recalcitrant)
Primary
Survey
Model
:
2.8245
(weeks
)
Readily
Biodegradable
Probability
(MITI
Model):
Linear
Model
:
0.0719
Non
Linear
Model
:
0.0000
Atmospheric
Oxidation
(25
deg
C)
[AopWin
v1.90]:
Hydroxyl
Radicals
Reaction:
OVERALL
OH
Rate
Constant
=
0.5732
E
12
cm3/
molecule
sec
Half
Life
=
18.659
Days
(12
hr
day;
1.5E6
OH/
cm3)
Ozone
Reaction:
No
Ozone
Reaction
Estimation
Soil
Adsorption
Coefficient
(PCKOCWIN
v1.66):
Koc
:
3380
Log
Koc:
3.529
Aqueous
Base/
Acid
Catalyzed
Hydrolysis
(25
deg
C)
[HYDROWIN
v1.67]:
Total
Kb
for
pH
>8
at
25
deg
C
:
6.174E
012
L/
mol
sec
Kb
Half
Life
at
pH
8:
3.558E+
009
years
Kb
Half
Life
at
pH
7:
3.558E+
010
years
BCF
Estimate
from
Log
Kow
(BCFWIN
v2.14):
Log
BCF
=
2.488
(BCF
=
307.5)
log
Kow
used:
4.14
(expkow
database)
Volatilization
from
Water:
Henry
LC:
5.14E
006
atm
m3/
mole
(Henry
experimental
database)
Half
Life
from
Model
River:
196
hours
(8.166
days)
Half
Life
from
Model
Lake
:
2281
hours
(95.05
days)
Removal
In
Wastewater
Treatment:
Total
removal:
36.98
percent
Total
biodegradation:
0.37
percent
Total
sludge
adsorption:
36.43
percent
Total
to
Air:
0.18
percent
Level
III
Fugacity
Model:
Mass
Amount
Half
Life
Emissions
(percent)
(hr)
(kg/
hr)
Air
1.37
1.83e+
003
1000
Water
12.5
3.6e+
003
1000
Soil
80.6
3.6e+
003
1000
Sediment
5.53
1.44e+
004
0
Persistence
Time:
2.22e+
003
hr
Appendix
B
INITIAL
REVIEW
EXPOSURE
REPORT
INITIAL
REVIEW
EXPOSURE
REPORT
CASE
NUMBER:
Lindane
ENVIRONMENTAL
RELEASES
OF
CHEMICALS
IN
HOUSEHOLD
PRODUCTS
SCENARIO
#:
1
EXPOSED
POPULATION:
WWT
REMOVAL
(%)
HOUSEHOLD
RELEASE
DAYS
PRE
TREATMENT
RELEASE
(g/
person/
day)
POST
TREATMENT
RELEASE
(g/
person/
day)
BODY
WEIGHT
(kg)
BCF
(L/
kg)
36.98
365.00
1.92E
05
1.
21E
05
71.80
307.50
PRODUCTION
VOLUME
(kg/
yr)
CONCENTRATION
OF
CONCERN
(ug/
L)
#
DAYS
CONC
OF
CONCERN
EXCEEDED
%YEAR
CONC
OF
CONCERN
EXCEEDED
HIGH
END
SURFACE
WATER
CONCENTRATION
(ug/
L)
MEDIAN
SURFACE
WATER
CONCENTRATION
(ug/
L)
1914.60
2.00E
02
6.
67
1.
83
4.
41E
04
3.
40E
05
| epa | 2024-06-07T20:31:43.177550 | regulations | {
"license": "Public Domain",
"url": "https://downloads.regulations.gov/EPA-HQ-OPP-2002-0202-0017/content.txt"
} |
EPA-HQ-OPP-2002-0202-0018 | Supporting & Related Material | "2002-08-14T04:00:00" | null | Quantitative
Usage
Analysis
of
Lindane
Analyst:
Istanbul
Yusuf
Case
#
315
AI
#
9001
February
27,
2002
Lindane
is
used
for
seed
treatment
of
small
grains,
field
corn
and
sorghum.
Approximately
142,000
pounds
of
lindane
are
applied
to
9.
7
million
acres
of
small
grains,
corn,
and
sorghum.
Lindane
is
applied
at
an
average
of
0.
0147
pounds
active
ingredient
per
acre.
The
vast
majority
(98%)
of
lindane
seed
treatment
are
incorporated
in
the
seed
on
farm.
Very
little
is
incorporated
into
seed
by
seed
processors.
Site
Acres
Grown
Acres
treated
Wtd
Average
Acres
treated
Est.
Max
%crop
Treated
Wtd.
Avg.
%crop
Treated
Est.
Max.
Lb
ai
Applied
Wtd.
Avg.
Lb
ai
Applied
Est.
Max.
Avg.
Appl.
Rate
State
of
Most
Usage
Wheat/
barley
68,373,000
4,786,110
8,197,560
7%
12%
89,422
153,294
0.0187
MN,
MT,
KS,
ND
93%
Oats/
rye
5,812,000
58,120
116,240
1%
2%
843
1,685
0.0145
ND,
PA
100%
Corn
79,545,000
4,772,700
7,159,050
6%
9%
51,545
77,318
0.0108
KS,
FL,
MD,
DE,
IA,
MI
76%
Sorghum
9,
195,000
91,950
183,900
1%
2%
331
662
0.0036
TX
100%
Total/
Average
9,
708,880
15,656,750
142,141
232,960
SOURCES:
EPA
Proprietary
Data
2001,
USDA
2001
Agricultural
Statistics,
Assessment
of
Insecticide
Use
for
Field
Crops
in
North
Dakota
for
2000
by
Glogoza,
P.
A.,
R.
Zollinger,
and
M.
McMullen,
Kansas
Agricultural
Cemical
Usage,
Product
Labels
of
Kernel
Guard
and
Agrox
D
L
plus.
| epa | 2024-06-07T20:31:43.182261 | regulations | {
"license": "Public Domain",
"url": "https://downloads.regulations.gov/EPA-HQ-OPP-2002-0202-0018/content.txt"
} |
EPA-HQ-OPP-2002-0202-0019 | Supporting & Related Material | "2002-08-14T04:00:00" | null | Page
1
UNITED
STATES
ENVIRONMENTAL
PROTECTION
AGENCY
WASHINGTON,
D.
C.
20460
OFFICE
OF
PREVENTION,
PESTICIDES
AND
TOXIC
SUBSTANCES
MEMORANDUM
Date:
February
5,
2002
SUBJECT:
BEAD's
Impact
Analysis
of
the
Seed
Treatment
Uses
of
Lindane
on
Wheat,
Barley,
Oats,
Rye,
Corn,
Sorghum,
and
Canola
FROM:
David
W.
Brassard,
Senior
Entomologist
Herbicide
and
Insecticide
Branch
Istanbul
Yusuf,
Economist
Economic
Analysis
Branch
Biological
and
Economic
Analysis
Division
(7503C)
THRU:
Arnet
Jones,
Chief
Herbicide
and
Insecticide
Branch
Arthur
Grube,
Senior
Economist
David
Widawsky,
Chief
Economic
Analysis
Branch
Biological
and
Economic
Analysis
Division
(7503C)
TO:
Mark
Howard,
Chemical
Review
Manager
Betty
Shackleford,
Chief
Reregistration
Branch
III
Special
Review
and
Reregistration
Division
(7508C)
Peer
Review
Date:
January
16,
2002
SUMMARY
In
response
to
a
request
for
SRRD,
BEAD
conducted
an
impact
analysis
of
the
seed
treatment
uses
of
lindane
on
wheat,
barley,
oats,
rye,
corn,
sorghum,
and
canola.
Lindane
seed
treatments
are
applied
to
9.
7
million
acres
of
small
grains,
corn,
and
sorghum
annually.
Imidacloprid
and
thiamethoxam,
the
primary
seed
treatment
alternatives
to
lindane,
are
as
effective
as
lindane
but
are
costlier
to
use.
There
are
no
registered
alternatives
to
lindane
for
oats
and
rye.
Grower
level
impacts
of
cancellation
of
lindane
seed
treatments
would
be
minor
for
all
uses,
except
oats
and
rye
where
they
are
considered
major
due
to
an
estimated
9
percent
yield
loss
Page
2
without
registered
alternatives.
Treatment
cost
increases,
associated
with
the
alternatives
for
the
remaining
crops
average
$1.45
per
acre
(or
0.8%
of
gross
revenues).
The
total
aggregate
increase
in
treatment
costs
is
$14
million.
Total
aggregate
value
of
yield
loss
(on
oats
and
rye)
is
$354,000
(Tables
1
and
3).
Lindane
is
not
currently
registered
on
canola
but
the
registrant
is
seeking
registration.
The
currently
registered
alternatives
are
equally
effective
for
wireworm
control
and
more
effective
for
flea
beetle
control
but
are
costlier
to
apply.
The
registration
of
lindane
would
result
in
an
average
cost
savings
to
growers
of
$1.83
per
acre
(2%
of
gross
revenues)
which
BEAD
considers
to
be
a
minor
gain.
GENERAL
BACKGROUND
ON
LINDANE
SEED
TREATMENTS
Approximately
142,000
pounds
of
lindane
are
applied
annually
to
9.7
million
acres
of
small
grains,
corn,
and
sorghum.
Lindane
is
applied
at
an
average
application
rate
of
0.
0147
pounds
active
ingredient
per
acre.
The
vast
majority
(98%)
of
lindane
seed
treatments
are
incorporated
into
the
seed
on
farm;
very
little
is
incorporated
into
the
seed
by
seed
processors.
Lindane
is
marketed
as
a
seed
treatment
under
trade
names
such
as
Agrox
Premiere®,
Germate
Plus®,
Isotox
F®,
and
Kernel
Guard®.
Lindane
treated
seed
is
applied
at
planting
time
mainly
for
wireworm
control.
Lindane
is
relatively
ineffective
against
seed
corn
maggot,
seed
corn
beetle,
and
white
grubs
(Brassard
and
Grube,
1996).
On
corn,
lindane
is
frequently
formulated
with
diazinon
to
control
these
other
insect
pests
and
with
fungicides
(e.
g.
captan,
carboxin,
and
maneb)
to
control
seedling
fungal
diseases.
On
small
grains
lindane
is
frequently
formulated
with
maneb,
but
is
rarely
formulated
with
diazinon.
Lindane
seed
treatments
are
also
applied
for
fire
ant
control
on
sorghum
and
the
registrant
has
petitioned
the
Agency
for
registration
on
canola
for
flea
beetle
and
wireworm
control.
Wireworm
damage
to
small
grains,
corn
and
sorghum
is
largely
a
problem
in
the
northern
wheat
growing
areas
west
of
the
Mississippi
River.
Wireworms
require
from
3
to
5
years
to
complete
their
growth
and
are
most
common
in
muck
and
other
loose
textured
soils
that
were
planted
to
grain
crops
in
previous
years.
Wireworms
attack
the
seeds
and
the
portion
of
the
stem
below
ground,
often
damaging
or
killing
the
growing
point.
Infested
fields
usually
have
spotty
stands
with
significant
reductions
in
plant
population
in
some
areas.
BEAD's
review
of
available
data
shows
that
untreated
plots
may
experience
yield
losses
of
0
to
18
percent
relative
to
lindane
treated
plots.
This
analysis
estimates
the
economic
impacts
of
cancellation
of
lindane
quantitatively
(revenue
losses
or
cost
increases
in
US
dollars)
and
qualitatively
(in
terms
of
the
effects
of
projected
impacts
on
grower
net
revenues).
The
criteria
for
qualitative
impact
characterizations
(minor:
0
3%
loss
in
gross
revenues,
moderate:
3
7%
loss,
and
major
7
20%
loss)
are
adapted
from
Brassard
and
Grube
(1998).
BEAD
could
only
obtain
prices
for
multiple
active
ingredient
lindane
products
which
contained
diazinon
and
captan
in
addition
to
lindane.
In
contrast,
alternative
seed
treatment
insecticides
are
marketed
only
as
single
active
ingredient
products.
In
order
to
estimate
the
value
Page
3
of
the
lindane
component
of
the
formulated
product,
BEAD
prorated
the
cost
by
assuming
that
all
active
ingredients
in
the
product
had
an
equal
value
on
a
weight
to
weight
basis.
WHEAT
AND
BARLEY
Background
About
62
million
acres
of
wheat
and
5.
8
million
acres
of
barley
are
planted
in
the
U.
S
annually
(USDA
2001).
Kansas,
Montana,
North
Dakota,
Oklahoma,
and
Texas
are
the
major
wheat
producing
states
and
Idaho,
Montana,
North
Dakota,
and
Washington
are
the
major
barley
producing
states.
Wheat
and
barley
are
relatively
low
cash
value
crops
with
gross
revenues
of
$113
and
$122
per
acre
respectively.
Lindane
is
applied
to
about
7
percent
of
U.
S.
grown
wheat
and
barley
for
control
of
wireworms.
Lindane
is
frequently
formulated
with
maneb
(for
control
of
seedling
diseases),
but
is
rarely
formulated
with
diazinon.
The
majority
(96%)
of
lindane
seed
treatment
on
wheat
and
barley
occurs
on
farm
(Glogoza
et
al,
2001;
Zollinger,
1996).
One
reason
for
this
is
that
much
of
the
seed
is
produced
on
farm
(KSU,
1999).
For
this
reason,
most
growers
are
not
likely
to
purchase
pre
treated
commercial
seed
if
lindane
is
no
longer
available.
Some
thiamethoxam
and
imidacloprid
products
can
only
be
applied
by
commercial
seed
treaters
and
therefore
would
not
be
useful
as
an
alternative
to
lindane
for
many
small
grain
producers.
Comparative
Performance
of
Alternatives
Imidacloprid
(Gaucho®)
and
thiamethoxam
(Adage®)
are
the
primary
alternatives
to
lindane.
Review
of
two
comparative
efficacy
trials
for
control
of
wireworms
on
wheat
and
three
for
wireworm
control
on
corn
lead
BEAD
to
conclude
that
imidacloprid
is
as
effective
as
lindane
in
controlling
wireworms
(at
the
rate
of
0.
005
to
0.
01
lb
ai/
cwt
seed).
In
wireworm
trials
on
corn,
thiamethoxam
is
as
effective
as
lindane
and
imidacloprid.
Thiamethoxam
is
labeled
for
use
on
wheat
at
higher
rates
(0.
029
to
0.
052
lbs
ai/
cwt
seed)
than
imidacloprid,
but
in
BEAD's
opinion
(based
on
available
data)
would
be
as
effective
as
imidacloprid
or
lindane
at
the
lower
rates
(0.005
to
0.01
lb
ai/
cwt
seed).
Economic
Impacts
of
Cancellation
Minor.
In
the
absence
of
lindane,
wheat
and
barley
growers
would
substitute
imidacloprid
seed
treatments
and
experience
increased
treatment
costs
of
$0.
36
1.
71
per
acre
(0.
3
1.
5%
of
gross
revenues)
(Tables
2a
and
3).
At
currently
registered
rates,
thiamethoxam
seed
treatments
would
be
prohibitively
expensive
($
8
to
$14
per
acre)
and
would
not
be
adopted
by
growers
(Table
2b).
Assuming
an
average
treatment
cost
increase
of
$1.035
per
acre,
the
aggregate
value
of
increased
treatment
cost
is
$5
million.
OATS
and
RYE
Background
Page
4
About
4.
5
million
acres
of
oats
and
1.
3
million
acres
of
rye
are
planted
in
the
U.
S.
annually
(USDA
2001).
California,
Iowa,
Minnesota,
North
Dakota,
Oklahoma,
South
Dakota,
Texas,
and
Wisconsin
are
the
major
oat
producing
states
and
Georgia,
Oklahoma,
and
Texas
are
the
major
rye
producing
states.
Oats
and
rye
are
relatively
low
cash
value
crops
with
gross
revenues
of
$71
per
acre.
Additionally,
only
about
52
percent
of
oats
and
25
percent
of
rye
are
harvested.
The
remainder
is
pastured,
grown
as
a
cover
crop,
or
experienced
a
crop
failure.
BEAD
assumed
that
all
lindane
treated
acreage
is
harvested.
Lindane
is
applied
to
about
1
percent
of
U.
S.
grown
oats
and
rye
for
control
of
wireworms.
Lindane
seed
treatment
on
oats
and
occurs
only
on
farm
(Glogoza
et
al,
2001;
Zollinger,
1996).
Oats
and
rye
are
less
susceptible
to
wireworm
attack
than
wheat
and
barley
(Glogoza,
2001).
Comparative
Performance
of
Alternatives
There
are
no
registered
alternatives
for
wireworm
control
on
oats
and
rye.
If
registered,
imidacloprid
and
thiamethoxam
are
likely
to
be
as
effective
as
lindane.
BEAD's
review
of
available
efficacy
data
shows
that
lindane
treated
plots
had
0
to
23
percent
more
plants
than
untreated
plots.
Assuming
that
the
stand
loss
to
yield
loss
ratio
is
the
same
as
field
corn,
this
translates
to
yield
losses
of
0
to
18
percent
if
wireworm
populations
are
not
controlled.
(Brassard
and
Grube,
1996).
BEAD
estimates
that
growers
with
wireworm
infestations
would
suffer
an
average
yield
loss
of
9
percent
if
lindane
were
no
longer
available.
Economic
Impacts
of
Cancellation
Major.
In
the
absence
of
lindane,
growers
may
suffer
a
9%
yield
loss
which
would
be
partially
offset
by
a
$0.77
per
acre
cost
savings.
Assuming
that
all
lindane
treated
acreage
is
harvested,
the
total
aggregate
value
of
yield
loss
is
$354,000
(Tables
1
and
3).
These
losses
would
be
partially
offset
by
a
cost
savings
of
$45,000
to
net
an
aggregate
impact
of
cancellation
of
$309,000
(or
0.
2%
of
the
total
US
crop
value)
(Table
4).
These
impacts
would
be
significantly
reduced
if
imidacloprid
were
registered
for
use
on
oats
and
rye.
FIELD
CORN
Background
About
80
million
acres
of
field
corn
are
planted
in
the
U.
S
annually
(USDA
2001).
Illinois,
Indiana,
Iowa,
Kansas,
Minnesota,
Nebraska,
Ohio,
South
Dakota,
and
Wisconsin
are
the
major
corn
producing
states.
Field
corn
gross
revenues
average
$256
per
acre.
Lindane
is
applied
at
planting
time
as
a
seed
treatment
to
about
6
percent
of
U.
S.
grown
field
corn
for
wireworm
control.
Lindane
is
relatively
ineffective
against
seed
corn
maggot,
seed
corn
beetle,
and
white
grubs
(Brassard
and
Grube,
1996).
Lindane
is
frequently
formulated
with
diazinon
to
control
these
other
pests
and
with
fungicides
(e.
g.
captan,
carboxin,
and
maneb)
to
control
seedling
fungal
diseases.
Lindane
seed
treatment
on
corn
occurs
exclusively
on
farm
Page
5
(Buckley,
2002).
Comparative
Performance
of
Alternatives
Imidacloprid
(Gaucho®),
thiamethoxam
(Adage®),
permethrin
(Kernel
Guard
Supreme®)
and
tefluthrin
(Raze®)
seed
treatments
are
the
primary
seed
treatment
alternatives
to
lindane.
Review
of
available
comparative
efficacy
data
for
control
of
wireworms
on
field
corn
lead
BEAD
to
conclude
that
imidacloprid
and
thiamethoxam
are
as
effective
as
lindane
in
controlling
wireworms
(at
the
rate
of
0.
05
lb
ai/
cwt
seed)
but
that
permethrin
and
tefluthrin
seed
treatments
perform
inconsistently
and
are
less
effective
than
lindane
some
of
the
time.
Economic
Impacts
of
Cancellation
Minor.
In
the
absence
of
lindane,
growers
would
substitute
imidacloprid
or
thiamethoxam
seed
treatments
and
experience
increased
treatment
costs
of
$1.82
per
acre
(0.7%
of
gross
revenues).
The
aggregate
value
of
the
increased
treatment
cost
would
be
$8.
7
million.
SORGHUM
About
9
million
acres
of
sorghum
are
planted
in
the
U.
S
annually
(USDA
2001).
Kansas
and
Texas
are
the
major
sorghum
producing
states.
Sorghum
is
a
relatively
low
cash
value
crop
with
gross
revenues
averaging
$107
per
acre.
Lindane
is
applied
at
planting
time
as
a
seed
treatment
to
about
1
percent
of
U.
S.
grown
sorghum
for
control
of
wireworms
and
suppression
of
imported
fire
ants
.
Comparative
Performance
of
Alternatives
Imidacloprid
(Gaucho)
and
thiamethoxam
(Adage®
,
Cruiser®
)
are
the
primary
alternatives
to
lindane.
BEAD
was
unable
to
locate
comparative
efficacy
data
for
control
of
wireworms
on
sorghum.
In
the
absence
of
suitable
data,
BEAD
assumes
that
imidacloprid
and
thiamethoxam
performance
against
wireworms
on
sorghum
is
about
the
same
as
what
was
reported
in
the
field
corn
comparative
efficacy
studies.
BEAD
reviewed
several
non
comparative
studies
for
suppression
of
fire
ants
on
sorghum
and
concluded
that
lindane
and
imidacloprid
are
equally
effective
in
fire
ant
suppression.
Imidacloprid
and
thiamethoxam
also
control
chinch
bugs,
greenbug,
and
yellow
sugarcane
aphid
on
sorghum
and
their
use
against
these
pests
has
been
shown
to
significantly
increase
yields
by
an
average
of
40
bushels
per
acre
in
moderate
to
heavy
infestations
(Brassard,
1994).
Economic
Impacts
of
Cancellation
Minor.
In
the
absence
of
lindane,
growers
would
substitute
imidacloprid
and
thiamethoxam
seed
treatments
and
experience
increased
treatment
costs
of
$3.70
4.69
per
acre
(3.
5
to
4.4%
of
gross
revenues).
Because
these
treatment
cost
increases
are
likely
to
be
offset
by
increased
yields
due
to
control
of
chinch
bugs
and
aphids,
the
overall
impact
of
lindane
Page
6
cancellation
is
believed
to
be
minor.
The
aggregate
value
of
the
increased
treatment
cost
is
estimated
to
be
$311,000.
CANOLA
About
1.
5
million
acres
of
canola
are
planted
in
the
U.
S
annually
(USDA
2001).
Minnesota,
North
Dakota,
and
Washington
are
the
major
canola
producing
states.
Canola
is
a
relatively
low
cash
value
crop
with
gross
revenues
averaging
$90
per
acre.
Lindane
is
not
currently
registered
for
use
on
canola
in
the
U.
S.
Lindane
is
used
on
canola
in
Canada
for
wireworm
and
flea
beetle
control.
Imidacloprid
is
currently
applied
to
about
58
percent
of
US
canola
acreage;
thiamethoxam
is
applied
to
about
2
percent
of
U.
S.
canola
acreage.
These
materials
are
incorporated
into
the
seed
entirely
by
seed
processors.
Parsons
(1998)
evaluated
21
field
trials
comparing
the
performance
of
thiamethoxam
with
lindane
and
imidacloprid
against
flea
beetle
on
canola
in
Canada.
Parsons
concluded
that
thiamethoxam
was
equal
to
or
better
than
lindane
in
performance
and
provided
longer
residual
activity
than
lindane
(14
28
days
vs
4
10
days).
Brassard
and
Alsadek
(1999)
reviewed
27
comparative
performance
comparisons
for
imidacloprid
and
14
for
thiamethoxam
and
concluded
that
both
materials
effectively
controlled
flea
beetles
and
achieved
yield
increases
of
17
and
59
percent
respectively
over
untreated
controls.
Comparative
Costs
If
registered,
lindane
seed
treatments
would
cost
about
$3.67
per
acre.
Currently
registered
seed
treatments
cost
about
$5.40
to
8.40
per
acre
(weighted
average
is
$5.50)
but
provide
more
effective
control
of
flea
beetles.
Registration
of
lindane
would
provide
growers
a
lower
cost
alternative
to
these
materials
for
short
term
control
of
low
to
moderate
flea
beetle
populations.
If
registered,
BEAD
estimates
that
10
percent
of
the
US
canola
crop
(150,000
acres)
would
be
treated
with
a
resultant
cost
savings
of
$1.83
per
acre
(2%
of
gross
revenues)
or
$274,500
nationally.
SEED
TREATMENTS
IN
THE
REGISTRATION
PIPELINE
Clothianidin,
a
chloronicotinyl
insecticide,
is
currently
in
the
registration
pipeline
for
corn
and
canola.
BEAD's
review
of
efficacy
data
submitted
by
the
registrant
indicate
that
it
is
effective
against
wireworms,
cutworms,
seedcorn
maggots,
white
grubs,
flea
beetles,
and
rootworms
on
corn
and
flea
beetles
on
canola
(Brassard,
2001).
Acetamiprid,
another
chloronicotinyl
insecticide,
is
currently
in
the
registration
pipeline
for
canola.
Efficacy
data
submitted
by
the
registrant
show
that
it
is
equal
to
or
more
effective
than
lindane
and
imidacloprid
for
control
of
flea
beetles
on
canola
(Christian
et
al.,
1999).
Preliminary
information
indicates
that
these
materials
will
cost
about
the
same
as
imidacloprid
and
thiamethoxam.
REFERENCES
Page
7
Brassard,
D.
W.
2001.
BEAD
Review
of
Clothianidin
seed
treatment
on
corn
and
canola.
Internal
Document.
Biological
and
Economic
Analysis
Division/
OPPTS/
EPA.
Brassard,
D.
W.
and
J.
Alsadek.
1999.
BEAD's
Review
of
Documentation
Submitted
by
Gustafson
and
Bayer
Corporation
in
Rebuttal
of
an
Emergency
Exemption
Request
for
the
Use
of
Thiamethoxam
(Helix®)
Seed
Treatment
on
Canola
to
Control
Flea
Beetles.
Internal
Document.
Biological
and
Economic
Analysis
Division/
OPPTS/
EPA.
Brassard,
D.
W.
1994.
BEAD
Review
of
Additional
Information
Provided
by
Gustafson
and
Gerald
Wilde
Regarding
the
Effectiveness
of
Imidacloprid
in
Controlling
Chinch
Bugs
and
Other
Insect
Pests
on
Sorghum.
Internal
Document.
Biological
and
Economic
Analysis
Division/
OPPTS/
EPA,
3
pp.
Brassard,
D.
W.
and
A.
Grube.
1996.
Final
Benefits
Evaluation
of
the
Use
of
At
Plant
Insecticides
on
Field
Corn.
Internal
Document.
Biological
and
Economic
Analysis
Division/
OPPTS/
EPA.
150
pp.
Brassard,
D.
W.
and
A.
Grube.
1998.
Using
Economic
Impacts
to
Qualitatively
Characterize
Grower
Level
Impacts
in
Agricultural
Crops:
The
QBCM
Model.
Internal
Document.
Biological
and
Economic
Analysis
Division/
OPPTS/
EPA.
2
pp.
Buckley,
M.
2002.
Telephone
Communication
with
David
Brassard
(1
18
01).
Mike
Buckley
Associates,
Lake
Tahoe,
CA,
775
832
3600.
Cress,
D.
2001.
Personal
Communication
with
Istanbul
Yusuf.
Kansas
State
University.
EPA
Proprietary
Data.
2001.
Glogoza,
P.
A.
2001.
Telephone
Communication
with
David
Brassard
(12
6
01).
Department
of
Entomology,
North
Dakota
State
University,
Fargo,
ND.
701
231
7581.
Glogoza,
P.
A.,
R.
Zollinger,
and
M.
McMullen.
2001.
Assessment
of
Insecticide
Use
for
Field
Crops
in
North
Dakota
for
2000.
North
Dakota
State
University,
Fargo,
ND.
Dollarhite,
G.
2001.
Personal
Communication
with
Istanbul
Yusuf.
Gustafson.
800
368
6130
KSU.
1999.
Kansas
Agricultural
Chemical
Usage:
1998
Wheat
and
Sorghum
Pesticide
Usage
Summary.
Kansas
State
University,
Manhattan
KS
Parsons,
J.
1998.
Efficacy
Review:
Helix
Seed
Treatment
for
Canola.
Canada
Pest
Management
Regulatory
Agency.
10
pp.
USDA
2001.
Agricultural
Statistics
2001.
USDA.
1999
2001.
Crop
Profiles
for
Wheat,
Barley,
Oats,
Corn,
Sorghum,
and
Canola.
Office
Page
8
of
Pest
Management
Policy,
USDA,
http://
pestdata.
ncsu.
edu/
cropprofiles/
Zollinger
et
al.,
1996.
Pesticide
Use
and
Pest
Management
Practices
for
Major
Crops
in
North
Dakota
1996.
Table
4:
On
Farm
Seed
Treatment.
North
Dakota
State
Univ.,
Fargo,
ND,
http://
www.
ag.
ndsu.
nodak.
edu/
aginfo/
entomology/
ndpiap/
Major_
Crops_
GS/
01table_
of_
c
ontents.
htm
EFFICACY
DATA
REVIEWED:
Arthropod
Management
Tests:
Vol
26:
F31,
Vol
25:
F41,
Vol
24:
F30,
Vol
23:
129F
Barr,
C.
L.,
B.
Drees,
and
B.
Vinson.
1991.
Evaluation
of
the
Lindane
Seed
Treatment,
Gammasan®,
To
Prevent
Predation
by
the
Red
Imported
Fire
Ant
on
Sorghum
Seed.
Department
of
Entomology,
Texas
A&
M
University
System,
in:
http://
fireant.
tamu.
edu/
research/
arr/
Category/
Site/
89
91Pg06/
89
91Pg06.pdf
Christian,
M.
L.
et
al
1999.
Reduced
Risk
and
Organophosphate
Replacement
Rationale
for
Acetamiprid:
Agricultural
Uses.
Rhone
Poulenc
Ag.
Company,
Research
Triangle
Park,
NC
27709,
p.
250
253.
Jarvi,
K.
and
T.
Hunt.
Insecticide
Screening
at
Emerson,
Nebraska
in
2001.
In
Crop
Watch
Newsletter
(October
12,
2001
issue),
University
of
Nebraska
Institute
of
Agriculture
and
Natural
Resources
Cooperative
Extension,
4
pp.
Keaster,
A.,
D.
Hoffman,
and
M.
O'Day.
1999.
Insecticide
Evaluations
for
Control
of
Wireworms
in
Corn.
In
Integrated
Crop
Management
Newsletter,
April
1999.
KSU.
2001.
Efficacy
of
Some
Common
Wheat
seed
Treatments
in
Kansas
2001.
Kansas
State
University
Wheat
Page
Rice,
M.
2000.
Wireworms
Part
1:
Insecticides
Evaluated
in
Missouri.
Integrated
Crop
Management
Newsletter,
March
2000,
p
19
20.
Gustafson.
2000.
Wireworm
Protection
with
Gaucho
480®
Low
Rate.
Page
9
Table
1
Economic
Impacts
of
Cancelling
Lindane
Seed
Treatment
Uses.
Crop
Lindane
usage
Alternatives
Comparative
Performance
Economic
Impacts
of
Cancellation
acres/%
treated
pounds
applied
Grower
level
impacts**
Aggregate
Impacts
wheat
barley
4,786,110
7%
89,
500
imidacloprid
thiamethoxam
Alternatives
equally
effective
for
wireworm
control.
Minor
Increased
treatment
costs
of
$0.36
1.71
per
acre
(0.3
1.5%
of
gross
revenues).
The
aggregate
value
of
increased
treatment
cost
is
$5
million
(0.06%
of
total
US
crop
value).
oats
rye
58,120
1%
843
none
registered
Untreated
plots
may
suffer
a
9%
yield
loss
relative
to
lindane
treated
plots.
Major
Growers
may
suffer
a
9%
yield
loss
which
would
be
partially
offset
by
a
$0.77
per
acre
cost
savings.
The
aggregate
impact
of
cancellation
would
be
$310,000
(0.
2%
of
the
total
crop
value).
canola
0%
0
imidacloprid
thiamethoxam
Alternatives
equally
effective
for
wireworm
control
and
more
effective
for
flea
beetle
control.
Not
Registered
Registration
of
lindane
would
result
in
an
aggregate
cost
savings
of
$1.83
per
acre
(2%
of
gross
revenues).
These
are
likely
to
be
offset
by
increased
yields
from
superior
flea
beetle
control
from
the
use
of
currently
registered
alternatives.
Lindane
is
not
currently
registered
on
canola
therefore
there
is
no
economic
impact.
Registration
of
lindane
would
result
in
an
aggregate
cost
savings
of
$275,000
corn
4,772,700
6%
51,
688
imidacloprid
thiamethoxam
permethrin
tefluthrin
Alternatives
equally
effective
for
wireworm
control.
Alternatives
also
control
seed
corn
maggot,
white
grubs
and
flea
beetles.
Minor
Increased
treatment
costs
of
$1.82
per
acre
(0.7%
of
gross
revenues).
The
aggregate
increased
treatment
cost
is
$8.
7
million
sorghum
91,950
1%
332
imidacloprid
thiamethoxam
Alternatives
equally
effective
for
wireworm
and
fire
ant
control.
Alternatives
also
control
chinch
bugs
and
aphids
Minor
Increased
treatment
costs
of
$3.70
4.69
per
acre
(3.5
4.4%
of
gross
revenues)
are
likely
to
be
offset
by
increased
yields
due
to
control
of
chinch
bugs
and
aphids.
The
aggregate
increased
treatment
cost
is
$386,000.
Page
10
all
uses
9,
708,880
142,364
imidacloprid
thiamethoxam
Alternatives,
when
available,
are
as
effective
as
lindane.
Average
treatment
cost
increase
of
$1.45
per
acre
(or
0.8%
of
gross
revenues).
Aggregate
treatment
cost
increase
of
14
million.
Aggregate
value
of
yield
loss
is
$354,000.
*
criteria
for
qualitative
grower
level
impact
descriptions:
minor:
0
3%
loss
in
gross
revenues,
moderate:
3
7%
loss,
major
7
20%
loss
in
gross
revenues
(adapted
from
Brassard
and
Grube,
1998
Page
11
Table
2a.
Comparative
Costs
of
Lindane
and
Imidacloprid
Seed
Treatments
Crops
Lindane
Cost/
Acre
Imidacloprid
Cost/
Acre*
Increased
Treatment
cost/
Acre
(using
imidacloprid)
Wheat/
Barley
$0.99
$1.35
2.70
$0.36
1.71
Oats/
rye
$0.77
N/
A
($
0.77)
Canola**
$3.67
$5.40
$1.73
Corn
$0.58
$2.40
$1.82
Sorghum
$0.19
$4.88
$4.69
*
imidacloprid
costs
obtained
from
Gustafson,
2001
(personal
communication
establishing
price
of
Gaucho®
480
at
$1200
per
gallon
or
$300
per
pound
active
ingredient)
**
assumes
growers
would
use
lower
rate
of
imidacloprid
on
canola
(higher
rate
costs
$18.43/
acre
treated)
Table
2b.
Comparative
Costs
of
Lindane
and
Thiamethoxam
Seed
Treatments
Crops
Lindane
Cost/
Acre
Thiamethoxam
Cost/
Acre*
Increased
Treatment
cost/
Acre
(using
thiamethoxam)
Wheat/
Barley
$0.99
$7.91
14.03
$6.92
13.04
Oats/
rye
$0.77
N/
A
($
0.77)
Canola
$3.67
$8.40
$4.73
Corn
$0.58
$2.40
$1.82
Sorghum
$0.19
$3.89
$3.70
*
Cost
data
was
not
available
for
most
thiamethoxam
uses.
Thiamethoxam
costs
for
most
uses
were
estimated
by
assuming
treatment
costs
per
pound
active
ingredient
were
the
same
as
imidacloprid
(i.
e.
$300
per
pound
ai)
Thiamethoxam
seed
treatments
are
applied
at
higher
rates
on
wheat
and
barley
and
would
be
significantly
more
expensive
and
unlikely
to
be
used
as
alternatives
to
lindane.
Prices
for
thiamethoxam
on
canola
($
8.40/
A)
are
from
:
http://
www.
canola
council.
org/
cpc/
99report/
180
181.pdf
;
cost
given
is
the
incremental
cost
(total
cost
minus
the
Page
12
cost
of
the
seed
and
a
fungicide
=
$9.02
per
acre
for
Eagle®
seed
treated
with
Benlate
fungicide)
Table
3.
Changes
in
Treatment
Cost
from
Substitution
of
Imidacloprid
and
Thiamethoxam
Seed
Treatments
for
Lindane
Seed
Treatment
(or
in
the
case
of
oats
and
rye,
substitution
of
no
treatment).
Crop
Acres
planted
%
acres
treated
Acres
treated
Increased
treatment
cost/
acre
Total
increased
treatment
cost
($)
Wheat/
barley
68,373,000
7%
4,786,110
$0.36$
1.71
$4,953,238*
Oats/
rye
5,812,000
1%
58,120
($
0.77)
($
44,752)
Corn
79,545,000
6%
4,772,700
$1.82
$8,686,314
Sorghum
9,
195,000
1%
91,950
$3.70$
4.69
$385,730**
Total/
Average
162,925,000
6%
9,708,880
$1.45
$14,070,034
*
assumes
average
treatment
cost
increase
of
$1.035
per
acre
**
sorghum
treatment
cost
increases
estimated
by
assuming
equal
adoption
of
imidacloprid
and
thiamethoxam
seed
treatments
Table
4.
Economic
Impact
of
lindane
cancellation
on
oats
and
rye
where
there
are
no
registered
alternatives.
Crops
Acres
Planted
%
acres
treated
Acres
treated
%
yield
loss
Lost
bushels
Price/
bushel
Value
of
crop
loss
Decreased
treatment
costs
Economic
impact
of
cancellation
Oats
4,477,000
1%
44,770
9%
258,681
$1.05
$271,615
$34,473
$237,142
Rye
1,
335,000
1%
13,350
9%
33,242
$2.49
$82,771
$10,280
$72,492
Total/
Weighted
average
5,812,000
1%
58,120
9%
291,923
$1.21
354,386
$44,752
$309,634
Page
13
Appendix
Table
1.
Calculation
of
Lindane
application
rates
Crop
average
seeding
rate
(lbs/
A)
Application
rate/
unit
Application
rate/
A
Source
barley
90
2
oz
16.6%
WP/
cwt
0.0187
Labeled
rate
of
sorghum
guard
=
0.
02075
lb
ai/
cwt
oats
70
2
oz
16.6%
WP/
cwt
0.0145
Labeled
rate
of
sorghum
guard
=
0.
02075
lb
ai/
cwt
rye
70
2
oz
16.6%
WP/
cwt
0.0145
Labeled
rate
of
sorghum
guard
=
0.
02075
lb
ai/
cwt
wheat
90
2
oz
16.6%
WP/
cwt
0.0187
Labeled
rate
of
sorghum
guard
=
0.
02075
lb
ai/
cwt
corn
20
1.94
oz.
25%
WP/
bushel
0.01083
Weighted
average
of
labeled
rate
of
Kernel
Guard
(2
oz/
bu)
and
Agrox
D
L
plus
(1.8
oz/
bu),
the
two
most
commonly
used
productson
corn.
Weights:
of
0.
705
for
Kernel
Guard
and
0.
295
for
Agrox
D
L
based
on
usage
data.
sorghum
6.
5
3
oz
16.6%/
bushel
0.
003613
Sorghum
Guard
3
oz
16.6%/
bushel
=
0.031125
lb
ai/
bu
=
0.003613
lb
ai/
A
canola
4.5
2250
ml
68%/
100
kg
0.069
labeled
rate
of
Vitavax
=
680g/
l
=
68%
lindane
Appendix
Table
2.
Calculation
of
Lindane
active
ingredient
costs
Product
Cost
per
pound
product
Lindane
%
Diazinon
%
Captan
%
Cost
per
lb
ai
of
lindane
($)
Prorated
cost
of
lindane
per
lb
ai**
Kernel
guard
28.54
25
15
15
114.16
51.89
Agrox
DL
30.84
25
15
15
123.36
56.07
Weighted
average*
29.22
25
15
15
116.87
53.12
*
Weighted
average
of
Kernel
Guard
and
Agrox
D
L
plus
(most
commonly
used
products)
(Weights:
0.
705/
0.295
based
on
usage
data)
**
estimated
cost
of
the
value
of
the
lindane
component
of
the
formulated
product.
Assumes
all
active
ingredients
in
product
have
an
equal
value
on
a
weight
to
weight
basis
Page
14
Appendix
Table
3.
Calculation
of
Lindane
Chemical
costs.
Crop
Application
rate
(lb
ai/
A)
Cost
per
lb
ai
lindane
Chemical
Cost
per
acre
Total
Product
cost
Prorated
cost
of
lindane
only
Total
Product
cost
Prorated
cost
of
lindane
only
barley
0.0187
$116.87
$53.12
$2.19
$0.99
oats
0.0145
$116.87
$53.12
$1.69
$0.77
rye
0.
0145
$116.87
$53.12
$1.69
$0.77
wheat
0.
0187
$116.87
$53.12
$2.19
$0.99
corn
0.01083
$116.87
$53.12
$1.27
$0.58
sorghum
0.
003613
$116.87
$53.12
$0.42
$0.19
canola
0.069
$116.87
$53.12
$8.06
$3.67
**
estimated
cost
of
the
value
of
the
lindane
component
of
the
formulated
product
(which
contain
other
active
ingredients
such
as
diazinon
and
captan).
Assumes
all
active
ingredients
in
product
have
an
equal
value
on
a
weight
to
weight
basis
Appendix
Table
4.
Calculation
of
Lindane
Usage
Estimates.
Crop
Acres
planted
%
acres
treated
Acres
treated
Application
Rate
(lbs
ai/
A)
Pounds
ai
applied
Wheat/
barley
68,373,000
7%
4,786,110
0.0187
89,500
oats/
rye
5,812,000
1%
58,120
0.0145
843
Corn
79,545,000
6%
4,772,700
0.01083
51,688
Sorghum
9,
195,000
1%
91,950
0.003613
332
Total/
Average
162,925,000
6%
9,708,880
0.01466
142,364
| epa | 2024-06-07T20:31:43.185077 | regulations | {
"license": "Public Domain",
"url": "https://downloads.regulations.gov/EPA-HQ-OPP-2002-0202-0019/content.txt"
} |
EPA-HQ-OPP-2002-0202-0020 | Supporting & Related Material | "2002-08-14T04:00:00" | null | Page
1
UNITED
STATES
ENVIRONMENTAL
PROTECTION
AGENCY
WASHINGTON,
D.
C.
20460
OFFICE
OF
PREVENTION,
PESTICIDES
AND
TOXIC
SUBSTANCES
MEMORANDUM
Date:
May
15,
2002
SUBJECT:
BEAD
Review
of
Korpalski
Handler
Exposure
Assessment
for
Lindane
Use
as
a
Seed
Treatment
in
the
U.
S.
FROM:
David
W.
Brassard,
Senior
Entomologist
Herbicide
and
Insecticide
Branch
Biological
and
Economic
Analysis
Division
(7503C)
THRU:
Arnet
Jones,
Chief
Herbicide
and
Insecticide
Branch
Biological
and
Economic
Analysis
Division
(7503C)
TO:
Mark
Howard,
Chemical
Review
Manager
Reregistration
Branch
III
Special
Review
and
Reregistration
Division
(7508C)
Peer
Review
Date:
May
8,
2002
SUMMARY
In
response
to
a
request
from
SRRD,
BEAD
reviewed
the
"Handler
Exposure
Assessment
for
Lindane
Use
as
a
Seed
Treatment
in
the
United
States"
submitted
by
Uniroyal
Chemical
Company.
BEAD
believes
that
the
application
rates
and
seed
planting
rates
used
in
Uniroyal's
assessment
are
reasonable
but
disagrees
with
Uniroyal's
estimate
of
80
acres
planted
per
day
for
corn,
wheat,
and
canola.
Based
on
the
Science
Advisory
Council
for
Exposure
Policy
Number:
9.1,
BEAD
believes
that
200
acres
planted
per
day
is
a
more
reasonable
upper
bound
estimate.
BEAD
also
disagreed
with
Uniroyal's
seed
treatment
equipment
throughput
assumptions
for
wheat
of
165,000
pounds
of
wheat
seed
per
day.
Based
on
personal
communications
with
seed
treaters
in
the
field
and
review
of
seed
treatment
equipment
technical
specifications,
BEAD
believes
that
commercial
seed
treaters
commonly
use
equipment
which
treats
480,000
pounds
of
wheat
seed
per
day.
BACKGROUND
1
BEAD
estimate
based
on
the
percentage
of
growers
using
4
to
20
row
planters
on
farm
sizes
less
than
500
acres
as
discussed
in
Brassard
and
Ng
(1993).
Page
2
In
response
to
a
request
from
SRRD,
BEAD
reviewed
the
"Handler
Exposure
Assessment
for
Lindane
Use
as
a
Seed
Treatment
in
the
United
States"
submitted
by
Uniroyal
Chemical
Company
and
Authored
by
Stefan
J.
Korpalski.
In
their
request,
SRRD
asked
BEAD
to
review
throughput
assumptions
and
lindane
handling
scenarios
made
by
the
registrant
in
their
risk
assessment
of
occupational
exposures
to
lindane.
BEAD's
REVIEW
OF
LINDANE
HANDLING
SCENARIOS
AND
THROUGHPUT
ASSUMPTIONS
The
application
rates
and
seed
planting
rate
used
in
the
Korpalski
study
appear
to
be
reasonable
(Table
1).
In
BEAD's
opinion,
Korpalski's
estimate
of
acres
planted
per
day
are
too
low.
Korpalski
assumed
an
80
acre
per
day
planting
rate
for
corn,
wheat,
and
canola.
Their
basis
was
that
this
is
the
standard
EPA
assumption
(Policy
009,
4/
1/
99).
EPA's
current
policy
(Science
Advisory
Council
for
Exposure
Policy
Number:
9.1,
revised
4/
25/
01)
for
granular
applications
to
corn
and
wheat
are
200
acres
per
day.
The
EPA
policy
estimates
are
based
(in
part)
on
an
analysis
by
Brassard
and
Ng
(1993)
which
assumed
the
use
of
20
row
(or
50
foot
wide)
planters
and
an
eight
hour
work
day.
These
estimates
should
be
considered
as
reasonable
upper
bound
(95
th
percentile)
1
.
BEAD
is
aware
of
situations
in
which
growers
working
long
hours
on
24
row
(60
foot
wide)
planters
have
planted
300
to
400
acres
in
a
day.
(Muggeridge,
1997).
In
BEAD's
opinion,
Korpalski's
seed
treatment
equipment
throughput
assumptions
are
reasonable
for
canola
but
on
the
low
side
for
wheat.
For
canola,
Korpalski
estimated
that
92,000
pounds
of
seed
could
be
treated
per
day
with
a
Gustafson®
continuous
batch
coater,
model
CBT50.
The
manufacturers
specifications
for
this
piece
of
equipment
state
that
it
is
capable
of
treating
up
to
13,000
lbs
of
seed
per
hour
or
104,000
pounds
of
seed
per
day
(Gustafson,
2002).
I
spoke
to
Roger
Weinlaeder
(of
Weinlaeder
Seeds
in
Drayton,
ND)
and
he
uses
a
Cerguard®
seed
treater
which
treats
an
average
of
5,000
pounds
of
canola
seeds
hour
and
can
treat
up
to
7,000
or
8,000
pounds
of
seed
per
hour
under
ideal
conditions
(equivalent
to
40,000
to
64,000
pounds
of
canola
seed
per
day
(Weinlaeder,
2002).
For
wheat,
the
Korpalski
assessment
assumed
that
wheat
seed
is
treated
with
equipment
such
as
the
Gustafson
S
100,
which
can
treat
about
165,000
lbs
of
wheat
seed
per
day.
Roger
Weinlaeder
treats
wheat
seed
with
a
Boss®
seed
treater
that
can
treat
60,000
pounds
of
seed
per
hour
or
480,000
pounds
of
seed
per
day
(Weinlaeder,
2002).
There
are
several
other
large
seed
treaters
commercially
available
that
can
treat
this
volume
(i.
e.
480,000
lbs
of
seed
per
day)
of
wheat
including
the
Petkus®
CTD
and
the
Niklas®
W.
N.
36
S
(Niklas,
2002,
Petkus,
2002)..
Table
1.
Comparison
of
Korpalski
and
BEAD
Estimates
Page
3
Crop
Application
Rate
(lbs
ai/
cwt)
Seed
Planting
Rate
(lbs/
acre)
Acres
Planted/
Treated
per
day
Seed
Treatment
Equipment
Throughput
Assumptions
(Pounds
of
seed
treated
per
day)
Korpalski
BEAD
Korpalski
BEAD
corn
0.056
14
80
200
wheat
0.031
120
80
200
165,000
480,000
canola
0.
75
5.
36
80
200
92,000
40,000
104,000
References
Brassard,
D.
W.
and
Y.
Ng.
1993.
Transmittal
of
Corn
Cluster
Exposure
Parameters.
Internal
Memorandum
Larry
Dorsey
(HED).
12
pp.
Gustafson,
2002.
Technical
Specifications
for
the
Gustafson
Continuous
Batch
Coater,
Model
CBT50,
http://
www.
gustafson.
com/
gustafson_
equipment/
id69.htm
Korpalski,
S.
J.
2002.
Handler
Exposure
Assessment
for
Lindane
Use
as
a
Seed
Treatment
in
the
United
States.
Exposure
study
submitted
to
EPA
by
Uniroyal
Chemical
Company,
Bethany,
CT
06524,
13
pp.
Muggeridge,
J.
M.
1997.
Up
to
400
acres
a
day.
Farm
&
Country
Magazine,
February
1997
issue,
Agricultural
Publishing
Company
Ltd.,
Ottawa,
Ontario,
Canada.
Niklas,
2002.
Technical
Specifications
for
the
Niklas
liquid
seed
treaters
type
W.
N.
36
S.
http://
www.
niklas
beizgeraete.
de/
English/
Conti_
Units/
Tech
Data/
tech
data.
html
Petkus,
2002.
Technical
Specifications
for
the
Petkus
CTD.
Seed
Treater.
http://
www.
petkus.
net/
treater.
htm#
THE
CTD
SERIES
Weinlaeder,
Roger.
2002.
Personal
Communication
with
David
W.
Brassard
on
4/
26/
02.
ND
Weinlaeder
Seeds,
Drayton,
ND.
701
454
6427
| epa | 2024-06-07T20:31:43.192166 | regulations | {
"license": "Public Domain",
"url": "https://downloads.regulations.gov/EPA-HQ-OPP-2002-0202-0020/content.txt"
} |
EPA-HQ-OPP-2002-0202-0021 | Supporting & Related Material | "2002-08-14T04:00:00" | null | Page
1
UNITED
STATES
ENVIRONMENTAL
PROTECTION
AGENCY
WASHINGTON,
D.
C.
20460
OFFICE
OF
PREVENTION,
PESTICIDES
AND
TOXIC
SUBSTANCES
MEMORANDUM
Date:
June
26,
2002
SUBJECT:
Revised
Estimates
of
the
Number
of
Acres
Treated
per
Day
for
Lindane
Seed
Treatment
Use
on
Field
Corn
FROM:
David
W.
Brassard,
Senior
Entomologist
Herbicide
and
Insecticide
Branch
Biological
and
Economic
Analysis
Division
(7503C)
THRU:
Arnet
Jones,
Chief
Herbicide
and
Insecticide
Branch
Biological
and
Economic
Analysis
Division
(7503C)
TO:
Mark
Howard,
Chemical
Review
Manager
Reregistration
Branch
III
Special
Review
and
Reregistration
Division
(7508C)
Peer
Review
Date:
June
26,
2002
SUMMARY
On
June
6,
2002,
BEAD
met
with
representatives
from
the
lindane
registrants,
Gustafson
and
Uniroyal,
to
reconcile
differences
in
the
assumptions
used
in
the
derivation
of
estimates
of
the
number
of
field
corn
acres
planted
with
lindane
treated
seed
per
day.
BEAD's
original
assumptions
produced
estimates
of
200
acres
treated
daily
whereas
the
registrant's
assumptions
produced
estimates
of
80
acres
treated
daily.
Based
on
farm
size
information
obtained
from
pesticide
usage
data
and
the
USDA
Agricultural
Census,
BEAD
refuted
the
registrants'
assumption
that
lindane
treated
seed
is
only
used
on
small
and
medium
size
farms
with
8
row
planters.
BEAD
believes
that
some
growers
planting
500
or
more
acres
of
corn
use
20
row
planters
to
apply
lindane
treated
seed.
BEAD
agreed
with
the
registrant's
assumption
of
longer
hopper
refill
times
(than
those
experienced
by
applicators
of
granular
pesticides)
for
pouring
and
mixing
the
seed
with
a
lindane
seed
treatment
product.
Based
on
the
revised
assumptions
provided
by
the
registrant,
BEAD
is
revising
its
previous
estimate
of
200
acres
of
field
corn
treated
with
lindane
seed
treatment
per
day
downward
to
180
acres
treated
per
day.
Page
2
BACKGROUND
In
response
to
a
request
from
SRRD,
BEAD
reviewed
the
"Handler
Exposure
Assessment
for
Lindane
Use
as
a
Seed
Treatment
in
the
United
States"
submitted
by
Uniroyal
Chemical
Company.
In
a
memo
dated
May
15,
2002,
BEAD
disagreed
with
Uniroyal's
estimate
of
80
acres
planted
per
day
for
corn
(Brassard,
2002).
Based
on
the
Science
Advisory
Council
for
Exposure
Policy
Number:
9.1
(Sandvig,
2001),
BEAD
estimated
that
200
acres
planted
per
day
was
a
more
reasonable
upper
end
estimate.
The
EPA
policy
estimates
were
based
(in
part)
on
an
analysis
by
Brassard
and
Ng
(1993)
which
assumed
the
use
of
20
row
planters
for
application
of
granular
insecticides
and
an
eight
hour
work
day.
DIFFERENCES
BETWEEN
BEAD
AND
REGISTRANT
SEED
TREATMENT
ASSUMPTIONS
On
June
6,
2002,
BEAD
met
with
representatives
from
the
lindane
registrants,
Gustafson
and
Uniroyal,
to
discuss
the
assumptions
used
in
the
derivation
of
these
exposure
estimates.
The
registrants
indicated
that
they
assumed
that
on
farm
products
are
typically
used
by
small
to
medium
sized
farm
operations
who
generally
use
8
row
planters.
When
queried,
the
registrants
indicated
that
they
had
no
factual
basis
for
this
assumption.
BEAD
explained
that
its
use
information
sources
indicated
that
the
average
field
size
for
lindane
treated
field
corn
was
145
acres
which
is
close
to
the
national
average
of
162
acres
(USDA,
1997a).
Nationally,
37%
of
all
field
corn
acreage
occurs
on,
and
7%
of
all
field
corn
growers
harvest,
over
500
acres
of
field
corn
(Table
1,
USDA,
1997b).
BEAD
believes
that
many
growers
planting
more
than
500
acres
of
corn
would
be
using
20
row
planters.
The
registrants
also
assumed
that
it
would
take
at
least
30
minutes
to
pour
and
mix
the
seed
and
lindane
seed
treatment
product
for
an
8
row
planter
(which
is
equivalent
to
about
3.
75
minutes
per
hopper)
and
that
an
8
row
planter
traveling
at
5
miles
per
hour
can
treat
an
acre
in
about
5
minutes
(assuming
a
30
inch
row
spacing)
or
about
84
acres
in
an
8
hour
day.
8
hours
=
480
minutes
30
minutes
to
refill
hoppers
x
2
refills
=
60
minutes
480
60
minutes
=
420
minutes
planting
time
remaining
in
8
hour
day
420
minutes
÷
5
minutes/
acre
=
84
acres
treated
in
an
8
hour
day
BEAD
agrees
with
the
registrant's
assumption
of
longer
hopper
refill
times
(than
those
experienced
by
applicators
of
granular
pesticides)
necessary
to
pour
and
mix
the
seed
and
lindane
seed
treatment
product.
Using
the
registrant's
assumptions
regarding
refill
times,
planter
speed,
and
row
spacing,
BEAD
calculated
that
a
grower
using
a
20
row
planter
could
treat
180
acres
in
an
eight
hour
day
8
hours
=
480
minutes
75
minutes
to
refill
hoppers
x
1.
5
refills
=
112.5
minutes
480
112.5
minutes
=
367.5
minutes
planting
time
remaining
in
8
hour
day
a
20
row
planter
traveling
at
5
miles
per
hour
can
treat
an
acre
in
about
2
minutes
1
Each
hopper
usually
takes
2
bags
of
seed
which
is
enough
to
treat
6
acres;
20
hoppers
x
6
acres
x
1.
5
refills
=
180
acres.
Page
3
367.5
minutes
÷
2
minutes/
acre
=
183.75
acres
treated
in
an
8
hour
day
However
since
1.
5
refills
of
a
20
row
planter
only
provides
enough
seed
to
treat
180
acres
1
,
BEAD
believes
that
this
is
a
more
realistic
estimate
for
exposure
assessment
purposes.
BEAD
believes
that
halving
the
refill
time
for
the
half
refill
is
practical
since
a
full
refill
requires
that
2
bags
of
seed
be
added
per
hopper
and
treated
and
thus
adding
only
1
bag
of
seed
per
hopper
could
be
accomplished
in
roughly
half
the
time.
CONCLUSION
BEAD
believes
that
the
registrant
estimate
of
84
acres
treated
per
day
represents
a
reasonable
central
value
exposure
scenario.
BEAD's
estimate
of
180
acres
treated
per
day
should
be
considered
as
reasonable
upper
end
estimate
for
an
8
hour
work
day.
However,
BEAD
is
aware
of
situations
in
which
growers
working
long
hours
on
24
row
planters
have
planted
300
to
400
acres
of
field
corn
in
a
day
(Muggeridge,
1997).
References
Brassard,
D.
W.
2002.
BEAD
Review
of
Korpalski
Handler
Exposure
Assessment
for
Lindane
Use
as
a
Seed
Treatment
in
the
U.
S.
Internal
Memorandum
to
Mark
Howard
dated
May
15,
2002.
Brassard,
D.
W.
and
Y.
Ng.
1993.
Transmittal
of
Corn
Cluster
Exposure
Parameters.
Internal
Memorandum
to
Larry
Dorsey
(HED).
12
pp.
EPA
Proprietary
Data.
2001.
Korpalski,
S.
J.
2002.
Handler
Exposure
Assessment
for
Lindane
Use
as
a
Seed
Treatment
in
the
United
States.
Exposure
study
submitted
to
EPA
by
Uniroyal
Chemical
Company,
Bethany,
CT
06524,
13
pp.
Muggeridge,
J.
M.
1997.
Up
to
400
acres
a
day.
Farm
&
Country
Magazine,
February
1997
issue,
Agricultural
Publishing
Company
Ltd.,
Ottawa,
Ontario,
Canada.
Sandvig,
R.
2001.
Science
Advisory
Council
for
Exposure:
Policy
Number
9.
1:
Standard
Values
for
Daily
Acres
Treated
in
Agriculture.
HED
internal
document
Revised:
September
25,
2001.
USDA.
1997a.
1997
United
States
Census
of
Agriculture
State
Data:
Table
26
Grains
Corn,
Sorghum,
Wheat,
and
Other
Small
Grains:
1997
and
1992.
USDA/
NASS,
Page
4
http://
www.
nass.
usda.
gov/
census/
census97/
volume1/
us
51/
us2_
25.pdf
USDA.
1997b.
1997
United
States
Census
of
Agriculture
United
States
Data:
Table
42.
Specified
Crops
by
Acres
Harvested:
1997,
USDA/
NASS
http://
www.
nass.
usda.
gov/
census/
census97/
volume1/
us
51/
us1_
42.pdf
Table
1.
Farm
Size
Distribution
of
Field
Corn
(for
grain
or
seed)
Acres
Harvested
per
farm
Number
of
farms
Acres
%
of
farms
%
of
acres
1
to
14
62,220
465,114
14.4%
0.7%
15
to
24
36,687
693,524
8.5%
1.0%
25
to
49
63,977
2,252,678
14.9%
3.2%
50
to
99
77,908
5,414,064
18.1%
7.8%
100
to
249
103,096
16,142,856
23.9%
23.1%
250
to
499
55,293
18,895,093
12.8%
27.1%
500
to
999
24,995
16,372,841
5.8%
23.5%
1,000
to
1,999
5,673
7,165,024
1.3%
10.3%
2,000
to
2,999
633
1,458,638
0.15%
2.1%
3,000
to
4,999
195
685,792
0.05%
1.0%
5,000
or
more
34
251,092
0.01%
0.4%
Total
430,711
69,796,716
100.0%
100.0%
Source:
USDA.
1997b.
1997
United
States
Census
of
Agriculture
United
States
Data:
Table
42.
Specified
Crops
by
Acres
Harvested:
1997,
USDA/
NASS
http://
www.
nass.
usda.
gov/
census/
census97/
volume1/
us
51/
us1_
42.pdf
| epa | 2024-06-07T20:31:43.195053 | regulations | {
"license": "Public Domain",
"url": "https://downloads.regulations.gov/EPA-HQ-OPP-2002-0202-0021/content.txt"
} |
EPA-HQ-OPP-2002-0202-0022 | Supporting & Related Material | "2002-08-14T04:00:00" | null | July
17,
2002
MEMORANDUM:
SUBJECT:
Lindane
(009001):
Reregistration
Case
0315.
Addendum
to
the
Revised
Chemistry
and
HED
Chapters
(DP
Barcode:
D279259
&
D283643)
for
the
Lindane
Reregistration
Eligibility
Document
(RED).
DP
Barcode:
D284183.
FROM:
Thurston
G.
Morton,
Chemist
Reregistration
Branch
4
Health
Effects
Division
(7509C)
THROUGH:
Susan
V.
Hummel,
Branch
Senior
Scientist
Reregistration
Branch
4
Health
Effects
Division
(7509C)
TO:
Rebecca
Daiss,
Risk
Assessor
Reregistration
Branch
4
Health
Effects
Division
(7509C)
And
Mark
Howard/
Betty
Shackleford
Reregistration
Branch
3
Special
Review
&
Reregistration
Division
(7508C)
This
memorandum
serves
to
update
the
Tolerance
Tables
contained
in
the
Product
and
Residue
Chemistry
Chapter
(T.
Morton,
12/
11/
01,
D279259)
and
the
HED
Risk
Assessment
(B.
Daiss,
6/
13/
02,
D283643)
by
amending
the
tolerances
which
were
listed
as
TBD
(to
be
determined).
Recommended
tolerance
levels
for
lindane,
per
se,
in
cereal
grains
are
derived
from
the
wheat
magnitude
of
the
residue
study
(T.
Morton,
8/
30/
00,
D259318).
Tolerances
will
be
re
evaluated
when
the
required
nature
of
the
residue
study
is
submitted.
2
EXECUTIVE
SUMMARY:
Residue
Chemistry
C
A
new
nature
of
the
residue
study
is
required
for
application
of
lindane
as
a
seed
treatment
to
a
cereal
grain.
C
If
the
HED
Metabolism
Assessment
Review
Committee
determines
the
residues
of
concern
to
include
metabolites
in
addition
to
lindane,
then
additional
crop
field
trial
data,
magnitude
of
the
residue
in
poultry
and
cattle,
and
processing
studies
are
required.
In
addition,
an
adequate
residue
analytical
method
and
storage
stability
data
will
be
required.
cc
:
Chem
F,
Chron
F.
Morton
RDI:
SVH:
7/
17/
02
TM,
Thurston
Morton,
Rm.
816D
CM2,
305
6691,
mail
code
7509C
3
TOLERANCE
REASSESSMENT
SUMMARY
Tolerances
for
residues
of
lindane
in/
on
raw
agricultural
and
animal
commodities
are
established
under
40
CFR
§180.133
and
expressed
in
terms
of
residues
of
lindane
per
se
[gamma
isomer
of
benzene
hexachloride].
The
residue
definition
for
lindane
is
misleading
and
should
be
amended
as
follows
to
harmonize
with
IUPAC
nomenclature:
gamma
isomer
of
1,2,3,4,5,6
hexachlorocyclohexane.
Plant
commodity
tolerances
for
lindane
were
originally
established
based
on
registered
uses
which
included
preplant
soil
application,
foliar
applications,
and
seed
treatments.
Animal
commodity
tolerances
were
established
based
on
uses
which
included
direct
livestock
animal
treatment
as
well
as
animal
premise
treatment.
Refer
to
Table
B
for
a
list
of
established
and
proposed
lindane
tolerances.
The
only
food/
feed
use
of
lindane
which
is
being
supported
for
reregistration
is
seed
treatment
on
cereal
grains
(excluding
rice
and
wild
rice).
At
this
time,
lindane
tolerances
are
being
reassessed
in
terms
of
lindane,
per
se.
The
nature
of
the
residue
in
plants
and
animals
must
be
adequately
elucidated,
and
HED's
MARC
must
determine
the
terminal
residues
of
concern.
The
tolerances
will
be
reevaluated
once
an
adequate
nature
of
the
residue
study
in
plants
is
submitted.
The
listing
of
lindane
tolerances
under
40
CFR
§180.133
should
be
subdivided
into
parts
(a),
(b),
(c),
and
(d).
Part
(a)
should
be
reserved
for
commodities
with
permanent
tolerances,
part
(b)
for
Section
18
emergency
exemptions,
part
(c)
for
tolerances
with
regional
registrations,
and
part
(d)
for
indirect
or
inadvertent
residues.
Tolerances
Listed
Under
40
CFR
§180.133:
Following
resolutions
of
residue
chemistry
data
deficiencies
specified
in
this
Residue
Chemistry
Science
Chapter,
a
statement
in
40
CFR
§180.133
should
be
added
to
specify
that
the
established
tolerances
result
from
seed
treatment
only.
The
established
tolerances
for
the
following
commodities
should
be
revoked
because
no
registrants
have
committed
to
support
their
uses:
apples,
apricots,
asparagus,
avocados,
broccoli,
Brussels
sprouts,
cabbage,
cauliflower,
celery,
cherry,
collards,
cucumbers,
eggplants,
grapes,
guavas,
kale,
kohlrabi,
lettuce,
mangoes,
melons,
mushrooms,
mustard
greens,
nectarines,
okra,
onions
(dry
bulb
only),
peaches,
pears,
pecans,
peppers,
pineapple,
plums
(fresh
prunes),
pumpkins,
quinces,
radish,
spinach,
squash,
strawberries,
summer
squash,
swiss
chard,
and
tomatoes.
Tolerances
To
Be
Proposed
Under
40
CFR
§180.133:
Tolerances
for
lindane,
per
se,
need
to
be
established
for:
barley,
grain;
barley,
hay;
barley,
straw;
corn,
grain;
corn,
forage;
corn,
stover;
oat,
grain;
oat,
forage;
oat,
hay;
oat,
straw;
rye,
grain;
rye,
forage;
rye,
straw;
sorghum,
grain;
sorghum,
forage;
4
sorghum,
stover;
wheat,
grain;
wheat,
forage;
wheat,
hay;
and
wheat,
straw.
In
addition,
tolerances
for
lindane,
per
se,
need
to
be
established
for
meat
byproducts
of
cattle,
goat,
horse,
and
sheep;
fat
of
cattle,
goat,
hog,
horse,
and
sheep;
milk;
and
fat
of
poultry.
The
remaining
livestock
tissues
(meat
and
meat
byproducts
of
hog
and
poultry;
and
eggs
are
40
CFR
180.6(
a)(
3)
[no
reasonable
expectation
of
finding
finite
lindane
residues]
provided
the
HED
MARC
determines
lindane,
per
se,
is
the
only
residue
of
concern.
The
tolerances
for
lindane,
per
se,
will
be
re
evaluated
once
adequate
nature
of
the
residue
data
in
plants
are
submitted.
Pending
Tolerance
Petitions:
In
1993,
CIEL
proposed
to
delete
all
food/
feed
uses
except
seed
treatment.
Concomitantly,
CIEL
proposed
to
establish
tolerances
of
0.1
ppm
for
residues
of
lindane
per
se
in/
on
several
RACs
as
a
result
of
seed
treatment.
In
an
initial
Agency
review
(DP
Barcode
D213401,
10/
31/
95,
S.
Funk)
of
available
residue
data
reflecting
seed
treatment,
the
Agency
concluded
that
the
proposed
tolerances
were
adequate
in
some
instances
and
inadequate
or
non
acceptable
in
others.
In
those
instances
where
the
proposed
tolerances
were
deemed
inadequate,
the
reviewer
proposed
values
that
HED
would
consider
as
appropriate.
In
1998,
CIEL
submitted
a
petition,
PP#
9F05057,
for
the
establishment
of
time
limited
tolerances
for
residues
of
lindane
per
se
in/
on
several
commodities
resulting
from
seed
treatment.
The
Agency
review
(DP
Barcodes
D254236,
8/
30/
00,
T.
Morton)
of
these
tolerance
proposals
concluded
that
tolerances
could
not
be
established
until
an
acceptable
nature
of
the
residue
study
in
plants
was
submitted.
At
this
time,
tolerance
levels
for
lindane,
per
se,
are
being
recommended
for
cereal
grains.
These
tolerances
will
be
re
evaluated
once
adequate
nature
of
the
residue
data
are
submitted.
The
registrants
have
also
submitted
PP#
9F6022,
(D269388,
T.
Morton,
5/
10/
01)
for
the
establishment
of
tolerances
on
lindane
per
se
in/
on
canola
for
which
seed
treatment
is
being
proposed.
Tolerances
cannot
be
established
until
adequate
nature
of
the
residue
data
in
plants
are
submitted.
5
Table
B.
Tolerance
Reassessment
Summary
for
Lindane.
Commodity
Tolerance
Listed
Under
40
CFR
(ppm)
Reassessed
Tolerance
(ppm)
Comment
[Correct
Commodity
Definition]
Tolerance
Listed
Under
40
CFR
§180.133
Apples
1
Revoke
Not
being
supported
for
reregistration.
Apricots
1
Revoke
Not
being
supported
for
reregistration.
Asparagus
1
Revoke
Not
being
supported
for
reregistration.
Avocados
1
Revoke
Not
being
supported
for
reregistration.
Broccoli
1
Revoke
Not
being
supported
for
reregistration.
Brussels
sprouts
1
Revoke
Not
being
supported
for
reregistration.
Cabbage
1
Revoke
Not
being
supported
for
reregistration.
Cauliflower
1
Revoke
Not
being
supported
for
reregistration.
Lettuce
3
Revoke
Not
being
supported
for
reregistration.
Spinach
1
Revoke
Not
being
supported
for
reregistration.
Celery
1
Revoke
Not
being
supported
for
reregistration.
Collards
1
Revoke
Not
being
supported
for
reregistration.
Kale
1
Revoke
Not
being
supported
for
reregistration.
Kohlrabi
1
Revoke
Not
being
supported
for
reregistration.
Mustard
greens
1
Revoke
Not
being
supported
for
reregistration.
Swiss
chard
1
Revoke
Not
being
supported
for
reregistration.
Cherry
1
Revoke
Not
being
supported
for
reregistration.
Cucumbers
3
Revoke
Not
being
supported
for
reregistration.
Eggplants
1
Revoke
Not
being
supported
for
reregistration.
Fat
of
meat
from
cattle,
goats,
horses,
and
sheep
7
0.
05
The
Agency
will
re
calculate
the
maximum
theoretical
dietary
burden
for
livestock
animals
and
re
evaluate
the
adequacy
of
the
available
animal
feeding
studies
when
the
required
nature
of
the
residue
data
in
plants
have
been
received
and
evaluated.
/
Cattle,
fat;
goat,
fat;
horse,
fat;
sheep,
fat
Hog,
fat
Fat
of
meat
from
hogs
4
0.
01
Grapes
1
Revoke
Not
being
supported
for
reregistration.
Guavas
1
Revoke
Not
being
supported
for
reregistration.
Mangoes
1
Revoke
Not
being
supported
for
reregistration.
Melons
3
Revoke
Not
being
supported
for
reregistration.
Mushrooms
3
Revoke
Not
being
supported
for
reregistration.
Nectarines
1
Revoke
Not
being
supported
for
reregistration.
Okra
1
Revoke
Not
being
supported
for
reregistration.
Onions
(dry
bulb
only)
1
Revoke
Not
being
supported
for
reregistration.
Peaches
1
Revoke
Not
being
supported
for
reregistration.
Pears
1
Revoke
Not
being
supported
for
reregistration.
Commodity
Tolerance
Listed
Under
40
CFR
(ppm)
Reassessed
Tolerance
(ppm)
Comment
[Correct
Commodity
Definition]
6
Pecans
0.
01
Revoke
Not
being
supported
for
reregistration.
Peppers
1
Revoke
Not
being
supported
for
reregistration.
Pineapple
1
Revoke
Not
being
supported
for
reregistration.
Plums
(fresh
prunes)
1
Revoke
Not
being
supported
for
reregistration.
Pumpkins
3
Revoke
Not
being
supported
for
reregistration.
Quinces
1
Revoke
Not
being
supported
for
reregistration.
Squash
3
Revoke
Not
being
supported
for
reregistration.
Strawberries
1
Revoke
Not
being
supported
for
reregistration.
Summer
squash
3
Revoke
Not
being
supported
for
reregistration.
Tomatoes
3
Revoke
Not
being
supported
for
reregistration.
Tolerance
To
Be
Proposed
Under
40
CFR
§180.133
Barley,
grain
None
established
0.005
A
nature
of
the
residue
study
for
lindane
residues
resulting
from
seed
treatment
application
to
a
cereal
grain
is
required.
The
Agency
will
recalculate
the
maximum
theoretical
dietary
burden
for
livestock
animals
and
re
evaluate
the
adequacy
of
the
available
animal
feeding
studies
when
the
required
nature
of
the
residue
data
in
plants
have
been
received
and
evaluated.
Barley,
hay
0.
02
Barley,
straw
0.
005
Corn,
field,
grain
0.
005
Corn,
pop,
grain
0.
005
Corn,
sweet,
kernel
plus
cob
with
husks
removed
0.005
Corn,
,
field,
forage
0.05
Corn,
sweet,
forage
0.05
Corn,
field,
stover
0.
05
Corn,
pop,
stover
0.
05
Corn,
sweet,
stover
0.
05
Oat,
grain
0.
005
Oat,
forage
0.05
Oat,
hay
0.
02
Oat,
straw
0.
005
Rye,
grain
0.
005
Rye,
forage
0.05
Rye,
straw
0.
005
Sorghum,
grain,
grain
0.
005
Sorghum,
forage
0.05
Sorghum,
grain,
stover
0.
05
Wheat,
grain
0.
005
Wheat,
forage
0.05
Wheat,
hay
0.
02
Wheat,
straw
0.
005
Cattle,
meat
byproducts
0.01
Commodity
Tolerance
Listed
Under
40
CFR
(ppm)
Reassessed
Tolerance
(ppm)
Comment
[Correct
Commodity
Definition]
7
Goat,
meat
byproducts
0.01
Horse,
meat
byproducts
0.01
Sheep,
meat
byproducts
0.01
Cattle,
meat
0.01
Goat,
meat
0.01
Horse,
meat
0.01
Sheep,
meat
0.01
Milk
0.01
Poultry,
fat
0.
01
CODEX
HARMONIZATION
The
Codex
Alimentarius
Commission
has
established
several
maximum
residue
limits
(MRLs)
for
lindane
in/
on
various
plant
and
animal
commodities.
The
Codex
MRLs
are
expressed
in
terms
of
gamma
HCH
(fat
soluble).
With
respect
to
tolerance
expression,
the
Codex
MRL
and
U.
S.
tolerance
for
lindane
are
presently
in
harmony.
However,
the
nature
of
the
residue
in
plants
remains
inadequately
understood,
and
the
HED's
MARC
may
determine
that
additional
lindane
metabolites
should
be
included
in
the
U.
S.
tolerance
expression.
A
numerical
comparison
of
the
Codex
MRLs
and
the
corresponding
reassessed
U.
S.
tolerances
resulting
from
seed
treatment
is
presented
in
Table
C.
The
established
Codex
MRLs
and
the
recommended
U.
S.
tolerances
for
Brussels
sprouts,
cabbage
(Savoy),
cabbages
(head),
cereal
grains,
lettuce
(head),
and
radish
are
not
in
harmony
presumably
because
of
differences
in
good
agricultural
practices.
Attempts
to
harmonize
residue
limits
in
animal
commodities
cannot
be
made
at
this
time
because
of
several
residue
chemistry
data
gaps.
Table
C.
Codex
MRLs
and
applicable
U.
S.
tolerances
for
lindane.
Recommendations
are
based
on
conclusions
following
reassessment
of
U.
S.
tolerances
(see
Table
B).
8
Codex
Reassessed
U.
S.
Tolerance,
ppm
1
Codex
Comments
Commodity,
As
Defined
MRL
in
mg/
kg
(Step)
Apple
0.
5
(CXL)
Revoke
Not
being
supported
for
reregistration.
Beans
(dry)
1
(CXL)
2
None
established
Not
being
supported
for
reregistration.
Brussels
sprouts
0.
5
(CXL)
Revoke
Not
being
supported
for
reregistration.
Cabbage,
Savoy
0.5
(CXL)
Revoke
Not
being
supported
for
reregistration.
Cabbages,
Head
0.5
(CXL)
Revoke
Not
being
supported
for
reregistration.
Cacao
beans
1
(CXL)
None
established
Not
being
supported
for
reregistration.
Carrot
0.
2
(CXL)
None
established
Not
being
supported
for
reregistration.
Cauliflower
0.
5
(CXL)
Revoke
Not
being
supported
for
reregistration.
Cereal
grains
0.5
(CXL)
2
0.005
ppm
for
the
grains
of
barley,
oats,
rye,
and
wheat
The
Agency
will
re
evaluate
the
cereal
grain
tolerances
when
the
required
nature
of
the
residue
data
in
plants
have
been
received
and
evaluated.
Cherries
0.5
(CXL)
Revoke
Not
being
supported
for
reregistration.
Cocoa
butter
1
(CXL)
None
established
Not
being
supported
for
reregistration.
Cocoa
mass
1
(CXL)
None
established
Not
being
supported
for
reregistration.
Cranberry
3
(CXL)
None
established
Not
being
supported
for
reregistration.
Currant,
Red,
White
0.5
(CXL)
None
established
Not
being
supported
for
reregistration.
Eggs
0.1
(CXL)
None
established
The
Agency
will
re
calculate
the
maximum
theoretical
dietary
burden
for
livestock
animals
and
re
evaluate
the
adequacy
of
the
available
animal
feeding
studies
when
the
required
nature
of
the
residue
data
in
plants
have
been
received
and
evaluated.
Endive
2
(CXL)
None
established
Not
being
supported
for
reregistration.
Codex
Reassessed
U.
S.
Tolerance,
ppm
1
Codex
Comments
Commodity,
As
Defined
MRL
in
mg/
kg
(Step)
9
Grapes
0.5
(CXL)
Revoke
Not
being
supported
for
reregistration.
Kohlrabi
1
(CXL)
Revoke
Not
being
supported
for
reregistration
Lettuce,
Head
2
(CXL)
Revoke
Not
being
supported
for
reregistration.
Meat
of
cattle,
pigs,
and
sheep
2
(CXL)
0.01
(cattle
and
sheep)
See
"Eggs"
Milks
0.
1
(CXL)
0.
01
See
"Eggs"
Pear
0.5
(CXL)
Revoke
Not
being
supported
for
reregistration.
Peas
(pods
and
succulent
=
immature
seeds)
0.1
(CXL)
None
established
Not
being
supported
for
reregistration.
Plums
(including
prunes)
0.5
(CXL)
Revoke
Not
being
supported
for
reregistration.
Potato
0.05
(CXL)
None
established
Not
being
supported
for
reregistration.
Poultry
meat
0.7
(CXL)
None
established
See
"Eggs"
Radish
1
(CXL)
Revoke
Not
being
supported
for
reregistration.
Rape
seed
0.05
(CXL)
None
established
Not
being
supported
for
reregistration.
Spinach
2
(CXL)
Revoke
Not
being
supported
for
reregistration.
Strawberry
3
(CXL)
Revoke
Not
being
supported
for
reregistration.
Sugar
beet
0.1
(CXL)
None
established
Not
being
supported
for
reregistration.
Sugar
beet
leaves
or
tops
0.1
CXL)
None
established
Not
being
supported
for
reregistration.
Tomato
2
(CXL)
Revoke
Not
being
supported
for
reregistration.
1
Reassessed
U.
S.
tolerances
pending
compliance
by
the
registrants
with
the
recommendations
specified
in
"GLN
860.1200:
Directions
for
Use"
section
of
this
Chapter.
2
Postharvest
treatment
of
the
commodity.
| epa | 2024-06-07T20:31:43.197941 | regulations | {
"license": "Public Domain",
"url": "https://downloads.regulations.gov/EPA-HQ-OPP-2002-0202-0022/content.txt"
} |
EPA-HQ-OPP-2002-0202-0023 | Supporting & Related Material | "2002-08-14T04:00:00" | null | April
17,
2002
MEMORANDUM:
SUBJECT:
Lindane
(009001):
Revised
Dietary
Risk
and
Exposure
Estimate
For
Lindane
Through
Subsistence
Diets
for
Indigenous
People
of
Alaska.
DP
Barcode
#
D282455.
Reregistration
Case
0315.
MRID
No.
none.
FROM:
Thurston
G.
Morton,
Chemist
Reregistration
Branch
4
Health
Effects
Division
(7509C)
THROUGH:
Susan
V.
Hummel,
Branch
Senior
Scientist
Reregistration
Branch
4
Health
Effects
Division
(7509C)
TO:
Mark
Howard/
Betty
Shackleford
Reregistration
Branch
3
Special
Review
&
Reregistration
Division
(7508C)
INTRODUCTION:
The
occurrence
of
organochlorine
contaminants
in
the
Arctic
has
been
documented
in
several
studies.
A
variety
of
organochlorine
contaminants
including
lindane
has
been
found
in
terrestrial,
freshwater,
and
marine
habitats.
This
contamination
is
primarily
the
result
of
long
range
continental
transport
through
the
movement
of
the
air
and
ocean
currents.
The
source
of
the
lindane
is
unknown
but
most
likely
reflects
past
uses
other
than
seed
treatment.
Lindane
is
the
gamma
isomer
of
hexachlorocyclohexane
(HCH)
and
is
also
known
as
gamma
isomer
of
benzene
hexachloride
(BHC).
Technical
HCH
contained
the
alpha,
beta,
delta,
and
gamma
isomers
but
was
banned
in
the
United
States
in
the
1970s.
The
composition
of
technical
HCH
varied
widely,
but
often
the
alpha
isomer
was
the
predominant
isomer.
Lindane
(gamma
isomer
of
HCH)
remains
registered
in
the
U.
S.
as
a
seed
treatment
only.
Studies
have
shown
higher
concentrations
of
lindane
and
total
HCH
in
some
wildlife
from
west
to
east.
This
is
thought
to
be
due
to
the
direction
of
air
currents.
2
The
Indigenous
Peoples
of
the
Arctic
region
of
the
U.
S.
(Alaska)
rely
heavily
on
subsistence
diets
as
their
food
source.
Thus,
it
is
appropriate
for
the
Agency
to
perform
a
supplementary
dietary
risk
and
exposure
assessment
to
assess
the
risk
to
the
Indigenous
People
from
worldwide
use
and
manufacture
of
lindane.
This
memorandum
serves
to
update
the
previous
dietary
assessment
performed
for
the
indigenous
people
of
Alaska
by
incorporating
new
information
pertaining
to
subsistence
meat
intake
by
children.
Because
the
annual
harvest
rates
were
divided
by
365
to
obtain
daily
harvest
rates,
and
the
daily
intake
rates
used
in
the
assessment
no
acute
dietary
exposure
analysis
was
conducted.
EXECUTIVE
SUMMARY:
Using
subsistence
food
harvest
amounts,
total
HCH
residues
in
traditional
foods,
and
adjusting
the
HCH
exposure
(since
lindane
represents
between
3
and
15
%
of
total
HCH
residues)
to
obtain
lindane
exposure
results
in
an
range
of
exposures
of
0.
0039
0.
04231
mg/
day.
Thus
dividing
this
exposure
by
70
kg
(weight
of
adult
male)
would
result
in
a
range
of
exposures
for
the
male
Indigenous
People
to
lindane
of
0.000055
0.
00060
mg/
kg
bw/
day
which
is
3
38
%
cPAD
and
below
HED's
level
of
concern
(cPAD
=
0.0016
mg/
kg
body
weight/
day).
Dividing
the
range
of
exposures
of
0.0039
0.
04231
mg/
day
by
60
kg
(weight
of
adult
female)
would
result
in
a
range
of
exposures
for
the
female
Indigenous
People
to
lindane
of
0.000064
0.
00071
mg/
kg
bw/
day
which
is
4
44
%
cPAD
and
below
HED's
level
of
concern.
The
adult
intake
amounts
from
each
community
were
adjusted
by
a
factor
of
0.53
to
correct
for
the
difference
in
subsistence
meat
intake
between
children
and
adults.
These
adjusted
child
intake
amounts
were
then
used
to
calculate
a
range
of
lindane
dietary
risk
estimates
for
children
1
6
years
old
resulting
from
subsistence
food
consumption
of
13
%
to
138
%
cPAD.
The
dietary
risk
estimates
resulting
from
subsistence
food
consumption
for
children
7
12
years
old
was
448
%
of
the
cPAD.
The
child
risks
also
incorporates
the
range
of
potential
lindane
residues
relative
to
total
HCH
(i.
e.,
3
15%).
HED
believes
these
estimates
may
be
an
overestimate
of
dietary
risk
since
dietary
intake
equaled
harvest
(i.
e.,
adults
consume
up
to
2.
4
pounds
of
subsistence
meat
per
day
and
children
consume
up
to
1.3
pounds
of
subsistence
meat
per
day).
Harvest
amounts
were
used
from
the
three
communities
of
approximately
180
Alaskan
communities
with
the
highest
seal
harvest,
highest
whale
harvest,
and
the
highest
walrus
harvest.
This
does
not
take
into
account
portions
of
the
harvest
which
were
discarded
or
used
for
non
dietary
purposes.
Also,
the
maximum
detected
HCH
residue
concentration
was
used
in
the
calculation
of
the
HCH
exposure
in
the
respective
subsistence
food
item.
For
example,
the
beluga
whale
blubber
HCH
concentration
was
assumed
for
the
entire
harvest
(and
consumption)
amount
and
not
taking
into
account
other
tissues
consumed
which
may
have
had
much
lower
residue
amounts.
3
DETAILED
CONSIDERATIONS:
Memoranda
providing
details
of
relevant
toxicological
information
include
the
HIARC
report
dated
6/
18/
01
and
the
FQPA
Safety
Factor
Committee
report
dated
8/
2/
00.
The
acute
and
chronic
FQPA
safety
factors
of
10X
were
reduced
to
3X
(see
FQPA
Safety
Factor
Document,
8/
2/
00).
A
reference
dose
(RfD)
which
includes
the
FQPA
safety
factor
(typically
10X,
3X
or
1X)
is
defined
as
the
Population
Adjusted
Dose
(PAD).
Doses
and
endpoints
for
dietary
risk
assessment
are
presented
in
Table
1.
The
chronic
population
adjusted
dose
(cPAD)
for
lindane
is
0.0016
mg/
kg/
day.
The
cPAD
is
the
chronic
RfD
of
0.0047
mg/
kg/
day
divided
by
the
FQPA
factor
of
3
yielding
a
cPAD
of
0.0016
mg/
kg/
day.
The
chronic
endpoint
and
dose
is
listed
in
Table
1
below.
The
Agency
used
the
subsistence
food
harvest
amounts
of
nearly
180
communities
from
the
Community
Profile
Database
Version
3.
11
dated
3/
27/
01
from
the
Alaska
Department
of
Fish
and
Game
Division
of
Subsistence
as
subsistence
food
intake
rates.
This
is
a
database
which
includes
the
harvest
of
subsistence
foods
in
Alaskan
communities
from
the
years
1990
2001.
From
personal
communication
with
Mr.
Roland
Shanks
from
the
Alaska
Inter
Tribal
Council
it
was
determined
that
usually
only
two
of
the
following
marine
mammals
(walrus,
seal,
and
whale)
are
harvested
in
significant
amounts.
Therefore,
HED
used
the
community
with
the
highest
representative
seal
harvest,
the
community
with
the
highest
walrus
harvest,
and
the
community
with
the
highest
whale
harvest.
Generally
polar
bear
and
another
marine
mammal
were
also
used
along
with
the
harvest
of
significant
amounts
of
fish,
land
mammal,
and
birds
from
the
corresponding
Alaskan
community.
HED
used
the
per
capita
harvest
amount
as
the
human
intake
amount
which
would
be
a
conservative
estimate
since
some
of
the
harvest
would
be
used
for
nonhuman
food
purposes
and
waste.
Variability
in
intake
amounts
have
been
shown
between
tribal
communities
within
Western
Canada.
It
is
therefore
likely
that
there
would
be
variability
in
intake
rates
between
tribal
communities
in
Alaska
depending
on
the
availability
of
fish
and
game
meat.
The
adult
intake
amounts
were
adjusted
by
a
factor
of
0.53
to
obtain
the
intake
amount
for
children.
This
factor
was
derived
from
a
publication
(Heller,
1966)
1
.
Population
Community
Pt.
Hope
Notak
Shungnak
Adult
Males
438
grams
429
grams
573
grams
Children
7
12
years
old
230
grams
230
grams
303
grams
Child's
%
of
Adults
Subsistence
Meat
Consumption
52.5
53.6
52.9
4
The
Agency
coupled
this
dietary
intake
data
with
organochlorine
residue
data
which
were
obtained
from
Dr.
Laurie
Chan
of
McGill
University
in
Canada
via
personal
communication.
The
report
gave
analytical
results
of
the
samples
for
total
hexachlorocyclohexane
(HCH)
and
not
the
individual
isomers.
Using
this
value
would
overestimate
the
risk
estimate
by
including
other
isomers
of
HCH
in
addition
to
lindane
which
is
the
gamma
isomer.
The
other
isomers
of
HCH
may
be
environmental
concentrations
resulting
from
previous
use
of
technical
HCH.
Therefore,
a
factor
of
0.03
or
0.15
was
used
to
multiply
the
total
HCH
exposure
to
account
for
exposure
to
lindane
only.
The
factor
of
0.03
or
0.15
was
derived
from
a
study
conducted
by
McGill
University
(Receveur,
1998)
in
which
lindane
and
total
HCH
was
measured.
Lindane
accounted
for
<3
to
15
%
of
the
total
HCH
present
in
samples
of
animal
tissue.
The
data
included
analytical
results
for
total
HCH
in
numerous
traditional
foods.
The
report
listed
a
maximum
residue
value
of
20
ng/
g
of
total
HCH
for
walrus
blubber,
215
ng/
g
for
ringed
seal
blubber,
9
ng/
g
for
moose
flesh,
1
ng/
g
for
caribou
flesh,
2
ng/
g
for
muskox
flesh,
4
ng/
g
for
Dall
sheep
flesh,
26
ng/
g
for
salmon
flesh,
20
ng/
g
for
whitefish
flesh,
6
ng/
g
for
arctic
char
flesh,
3
ng/
g
for
arctic
grayling
flesh,
1
ng/
g
for
cisco
flesh,
3
ng/
g
for
lake
trout
flesh,
348
ng/
g
for
ooligan
flesh
(which
in
this
assessment
will
be
used
for
cod,
smelt,
and
herring),
10
ng/
g
for
polar
bear
flesh,
391
ng/
g
for
beluga
whale
blubber,
7
ng/
g
for
eider
flesh,
1
ng/
g
for
goose
flesh,
4
ng/
g
for
gull
eggs,
and
10
ng/
g
preserved
soapberries.
Multiplying
the
maximum
HCH
concentration
in
the
traditional
food
by
the
harvest
amount
(converted
to
grams/
person/
day)
results
in
the
exposure
to
HCH
from
the
traditional
food
item.
Multiplying
the
residue
concentration
by
the
appropriate
traditional
food
amount
for
each
community
would
result
in
an
estimated
exposure
to
lindane
from
the
consumption
of
traditional
food.
Within
each
community,
the
individual
exposures
are
then
summed
for
a
total
exposure
to
lindane
in
traditional
food.
Summing
the
exposures
from
the
subsistence
food
sources
in
Community
1
(highest
total
exposure
of
the
three
communities)
amounts
to
an
exposure
to
total
HCH
of
282,065
ng/
day.
When
converted
to
mg/
day
this
exposure
becomes
0.
282065
mg/
day.
The
total
HCH
exposure
of
0.282065
mg/
day
must
be
adjusted
by
the
factor
of
0.03
or
0.15
(since
lindane
represents
between
3
and
15
%
of
total
HCH
residues)
to
obtain
the
lindane
only
exposure
yielding
a
lindane
exposure
for
Community
1
of
0.
0039
0.
04231
mg/
day.
This
value
must
be
divided
by
the
weight
of
an
adult
male/
female
in
kilograms
for
comparison
to
the
chronic
Population
Adjusted
Dose
(cPAD).
The
units
of
the
cPAD
are
mg/
kg
body
weight/
day.
The
cPAD
for
lindane
is
0.0016
mg/
kg
body
weight/
day.
Dividing
0.04231
(assuming
lindane
is
15%
of
total
HCH)
mg/
day
by
70
kg
(male
weight)
would
result
in
an
exposure
of
0.
0006
mg/
kg/
day.
Comparing
this
exposure
to
the
lindane
cPAD
of
0.0016
mg/
kg
body
weight/
day
reveals
that
the
exposure
of
the
male
Indigenous
People
to
lindane
is
38
%
cPAD
and
thus,
would
be
below
HED's
level
of
concern.
The
range
of
lindane
dietary
risk
estimates
for
adult
males
resulting
from
subsistence
food
consumption
is
3
%
to
38
%.
Dividing
0.
04231
mg/
day
by
60
kg
(female
weight)
would
result
in
an
exposure
of
0.0007
mg/
kg/
day.
Comparing
this
exposure
to
the
lindane
cPAD
of
0.0016
mg/
kg
body
weight/
day
reveals
that
the
exposure
of
the
female
Indigenous
People
to
lindane
is
44
%
cPAD
and
thus,
would
be
below
HED's
level
of
concern.
The
range
of
lindane
5
dietary
risk
estimates
for
adult
males
resulting
from
subsistence
food
consumption
is
4
%
to
44
%.
The
adult
intake
amounts
from
each
of
the
three
communities
were
adjusted
by
a
factor
of
0.53
to
incorporate
the
difference
in
subsistence
meat
intake
between
children
and
adults
1
.These
adjusted
child
intake
amounts
were
then
multiplied
by
the
respective
HCH
residue
amount
to
derive
a
total
HCH
exposure
from
each
subsistence
meat
source.
The
total
HCH
residue
amount
was
then
multiplied
by
0.
03
and
0.15
to
obtain
the
lindane
residue
amount.
The
lindane
residue
amount
was
then
divided
by
10
kg
(weight
of
child
1
6
years
old),
and
then
by
0.
0016
(cPAD)
to
obtain
the
%
cPAD
which
was
occupied
by
the
lindane
exposure
from
subsistence
foods
(Table
3).
The
range
of
lindane
dietary
risk
estimates
for
children
resulting
from
subsistence
food
consumption
is
13
%
to
138
%.
For
children
7
12
years
old,
the
lindane
residue
amount
was
divided
by
29
kg
(weight
of
child
7
12
years
old),
and
then
by
0.
0016
(cPAD)
to
obtain
the
%
cPAD
which
was
occupied
by
the
lindane
exposure
from
subsistence
foods
(Table
4).
The
range
of
lindane
dietary
risk
estimates
for
children
resulting
from
subsistence
food
consumption
is
4
%
to
48
%
of
the
cPAD.
Table
1.
Lindane:
Toxicological
Doses
and
Endpoints
for
Dietary
Risk
Assessment.
EXPOSURE
SCENARIO
DOSE
(mg/
kg/
day)
ENDPOINT
STUDY
TYPE/
MRID
Chronic
Dietary
NOAEL=
10
ppm
(0.
47
mg/
kg/
day)
UF
=
100
FQPA
=
3X
LOAEL
is
100
ppm
(4.
81
mg/
kg/
day)
periacinar
hepatocyte
hypertrophy,
increased
liver/
spleen
weight,
and
increased
platelets
Chronic
Feeding
and
Carcinogenicity
in
Rats
41094101
41853701
42891201
Chronic
RfD
=
0.
0047
mg/
kg/
day
Chronic
Population
Adjusted
Dose
(cPAD)
=
0.
0016
mg/
kg/
day
cPAD
=
RfD/
FQPA
Safety
Factor.
6
Table
2.
Community
Harvest
of
Traditional
Foods
and
total
HCH
residues.
Traditional
Food
Total
HCH
Residues
(ng/
g)
Community
1
Harvest
(grams/
person/
day)
Community
2
Harvest
(grams/
person/
day)
Community
3
Harvest
(grams/
person/
day)
Polar
Bear
10
9
26
16
Seal
215
39
500
46
Whale
391
697
271
Walrus
20
22
315
Caribou
1
123
103
221
Moose
9
81
Muskox
2
13
Dall
Sheep
4
20
Salmon
26
28
116
Arctic
Char
6
10
Lake
Trout
3
100
Arctic
Grayling
3
6
6
Whitefish
20
14
19
Cod
Residue
from
flesh
used
348
ng/
g
18
ooligan
Smelt
10
17
Herring
22
Cisco
1
39
8
19
Goose
1
14
15
14
Duck
7
12
Berries
10
15
Total
HCH
Exposure
282,065
ng/
day
130,045
ng/
day
128,879
ng/
day
7
Table
3.
Assumed
Total
Dietary
Intake
of
Lindane
(gamma
HCH)
and
Estimated
Risk
for
Indigenous
Children
16
yrs.
old.
%TotalHCHwhichis
Lindane
Community
1
(mg/
kg/
day)/%
cPAD
a
Community
2
(mg/
kg/
day)/%
cPAD
Community
3
(mg/
kg/
day)/%
cPAD
3%
Lindane
0.
00045/
28
0.00021/
13
0.00021/
13
15%
Lindane
0.
0022/
138
0.0010/
65
0.0010/
65
a
Example
calculation:
Exposure
=
0.
282
mg/
day
*
0.
15
or
0.
03
*
0.
53
/
10
kg
=
0.
0022
mg/
kg/
day
(15%
lindane)
or
0.00045
mg/
kg/
day
(3%
lindane).
Table
4.
Assumed
Total
Dietary
Intake
of
Lindane
(gamma
HCH)
and
Estimated
Risk
for
Indigenous
Children
712
yrs.
old.
%TotalHCHwhichis
Lindane
Community
1
(mg/
kg/
day)/%
cPAD
a
Community
2
(mg/
kg/
day)/%
cPAD
Community
3
(mg/
kg/
day)/%
cPAD
3%
Lindane
0.
0002/
10
0.00007/
4
0.
00007/
4
15%
Lindane
0.
0008/
48
0.0004/
22
0.0004/
22
a
Example
calculation:
Exposure
=
0.
282
mg/
day
*
0.
15
or
0.
03
*
0.
53
/
29
kg
=
0.
0008
mg/
kg/
day
(15%
lindane)
or
0.0002
mg/
kg/
day
(3%
lindane).
Table
5.
Assumed
Total
Dietary
Intake
of
Lindane
(gamma
HCH)
and
Estimated
Risk
for
Indigenous
Adult
Males.
%TotalHCHwhichis
Lindane
Community
1
(mg/
kg/
day)/%
cPAD
a
Community
2
(mg/
kg/
day)/%
cPAD
Community
3
(mg/
kg/
day)/%
cPAD
3%
Lindane
0.
00012/
8
0.
000056/
3
0.
000055/
3
15%
Lindane
0.
00060/
38
0.00028/
17
0.00027/
17
a
Example
calculation:
Exposure
=
0.
282
mg/
day
*
0.
15
or
0.
03
/
70
kg
=
0.
0006
mg/
kg/
day
(15%
lindane)
or
0.0001
mg/
kg/
day
(3%
lindane).
Table
6.
Assumed
Total
Dietary
Intake
of
Lindane
(gamma
HCH)
and
Estimated
Risk
for
Indigenous
Adult
Females.
%TotalHCHwhichis
Lindane
Community
1
(mg/
kg/
day)/%
cPAD
a
Community
2
(mg/
kg/
day)/%
cPAD
Community
3
(mg/
kg/
day)/%
cPAD
3%
Lindane
0.
00014/
9
0.
000065/
4
0.
000064/
4
15%
Lindane
0.
00071/
44
0.00033/
20
0.00032/
20
a
Example
calculation:
Exposure
=
0.
282
mg/
day
*
0.
15
or
0.
03
/
60
kg
=
0.
0007
mg/
kg/
day
(15%
lindane)
or
0.0001
mg/
kg/
day
(3%
lindane).
8
Table
7.
Assumed
Total
Dietary
Intake
of
Lindane
(gamma
HCH)
and
Estimated
Risk.
Population
Subgroup
Body
Weight
(kg)
Estimated
Lindane
Exposure
(mg/
kg/
day)
%cPAD
Adult
male
70
0.
000055
0.
0006
3
38
Adult
female
60
0.
000064
0.
00071
4
44
Children
(1
6
yrs)
10
0.
0002
0.
0022
13
138
Children
(7
12
yrs.)
29
0.
00007
0.0008
4
48
References:
1
Heller,
C.,
1966.
Meat
Consumption
at
Three
Northern
Eskimo
Villages.
Environment
of
the
Cape
Thompson
Region,
Alaska.
Wilimovsky,
Norman,
&
Wolfe,
John,
Editors.
United
States
Atomic
Energy
Commission.
pp.
1109
1111.
cc
:
Chem
F,
Chron
F.
Morton
RDI:
Team:
3/
27/
01;
SVH:
4/
17/
02
TM,
Thurston
Morton,
Rm.
816D
CM2,
305
6691,
mail
code
7509C
| epa | 2024-06-07T20:31:43.201392 | regulations | {
"license": "Public Domain",
"url": "https://downloads.regulations.gov/EPA-HQ-OPP-2002-0202-0023/content.txt"
} |
EPA-HQ-OPP-2002-0211-0001 | Notice | "2002-12-06T05:00:00" | Imazethapyr; Notice of Filing a Pesticide Petition to Establish a Tolerance for a Certain Pesticide
Chemical in of on Food | 72678
Federal
Register
/
Vol.
67,
No.
235
/
Friday,
December
6,
2002
/
Notices
The
Agency
has
maintained
that
polymers
meeting
the
polymer
exemption
criteria
will
present
minimal
risk
to
human
health
when
used
as
inert
ingredients
in
pesticide
products
applied
to
food
crops.
EPA
has
also
established
exemptions
from
tolerance
for
polymeric
materials
used
as
pesticide
inert
ingredients
that
it
considers
to
be
intrinsically
safe
based
on
the
fact
that
they
are
listed
on
the
TSCA
Inventory
or
meet
the
requirements
of
the
amended
TSCA
polymer
exemption
and
are
thereby
not
subject
to
the
requirements
of
the
premanufacturing
notification.
Any
exposure
resulting
from
the
approval
of
three
polymers
represented
by
a
hydro
hydroxypoly
oxyethylene)
C8
C18
alkyl
ether
citrates
in
pesticide
formulations
for
use
on
growing
crops
or
to
RAC
after
harvest
is
not
warranted.
D.
Cumulative
Effects
At
this
time
there
is
no
information
to
indicate
that
any
toxic
effects
produced
by
three
polymers
represented
by
ahydro
hydroxy
poly(
oxyethylene)
C8
C18
alkyl
ether
citrates
having
a
number
average
molecular
weight
of
at
least
1,100
would
be
cumulative
with
those
of
any
other
chemical
substance(
s).
Given
the
categorization
of
these
polymers
as
a
``
low
risk
polymer''
(
40
CFR
723.250)
and
their
proposed
use
as
inert
ingredients
in
pesticide
formulations,
there
is
no
reasonable
expectation
of
increased
risk
due
to
cumulative
exposure.
E.
Safety
Determination
1.
U.
S.
population.
As
a
matter
of
policy,
EPA
has
in
the
past
established
exemptions
from
tolerance
for
polymeric
substances
used
as
pesticide
inert
ingredients
that
it
considers
to
be
intrinsically
safe
based
on
the
fact
that
they
are
listed
on
the
TSCA
Inventory
or
meet
the
requirements
of
the
amended
TSCA
polymer
exemption
and
are
thereby
not
subject
to
the
requirements
of
premanufacture
notice
(
PMN).
The
Agency
has
maintained
that
polymers
meeting
the
polymer
exemption
criteria
will
present
minimal
risk
to
human
health
when
used
as
inert
ingredients
in
pesticide
formulations.
2.
Infants
and
children.
FFDCA
section
408
provides
that
EPA
shall
supply
an
additional
tenfold
margin
of
safety
for
infants
and
children
in
the
case
of
threshold
effects
where
prenatal
and/
or
postnatal
toxicity
are
found
or
there
is
incompleteness
of
the
database,
unless
EPA
concludes
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
the
use
of
margin
of
exposure
(
MOE)
analysis
or
through
using
uncertainty
(
safety)
factors
in
calculating
a
dose
level
that
poses
no
appreciable
risk
to
humans.
Due
to
the
low
expected
toxicity
of
these
three
polymers
represented
by
ahydro
hydroxy
poly(
oxyethylene)
C8
C18
alkyl
ether
citrates,
a
safety
factor
analysis
is
not
required
for
assessing
the
risk.
For
the
same
reasons
the
additional
safety
factor
is
unnecessary.
F.
International
Tolerances
Akzo
Nobel
Industrial
Specialties,
Inc.
is
not
aware
of
any
country
requiring
a
tolerance
for
the
three
polymers
represented
by
a
hydro
hydroxy
poly(
oxyethylene)
C8
C18
alkyl
ether
citrates
having
a
number
average
molecular
weights
of
at
least
1,100.
Nor
have
there
been
any
CODEX
Maximum
Residue
Levels
(
MRLs)
established
for
any
food
crops
at
this
time.
[
FR
Doc.
02
30946
Filed
12
5
02;
8:
45
am]
BILLING
CODE
6560
50
S
ENVIRONMENTAL
PROTECTION
AGENCY
[
OPP
2002
0211;
FRL
7283
3]
Imazethapyr;
Notice
of
Filing
a
Pesticide
Petition
to
Establish
a
Tolerance
for
a
Certain
Pesticide
Chemical
in
or
on
Food
AGENCY:
Environmental
Protection
Agency
(
EPA).
ACTION:
Notice.
SUMMARY:
This
notice
announces
the
initial
filing
of
a
pesticide
petition
proposing
the
establishment
of
regulations
for
residues
of
a
certain
pesticide
chemical
in
or
on
various
food
commodities.
DATES:
Comments,
identified
by
docket
ID
number
OPP
2002
0211,
must
be
received
on
or
before
January
6,
2003.
ADDRESSES:
Comments
may
be
submitted
electronically,
by
mail,
or
through
hand
delivery/
courier.
Follow
the
detailed
instructions
as
provided
in
Unit
I.
of
the
SUPPLEMENTARY
INFORMATION.
FOR
FURTHER
INFORMATION
CONTACT:
Jim
Tompkins,
Registration
Division
(
7505C),
Office
of
Pesticide
Programs,
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460
0001;
telephone
number:
(
703)
305
5697;
e
mail
address:
tompkins.
jim@
epa.
gov.
SUPPLEMENTARY
INFORMATION:
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:
Crop
production
(
NAICS
111)
Animal
production
(
NAICS
112)
Food
manufacturing
(
NAICS
311
Pesticide
manufacturing
(
NAICS
32532)
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
the
table
could
also
be
affected.
The
North
American
Industrial
Classification
System
(
NAICS)
codes
have
been
provided
to
assist
you
and
others
in
determining
whether
or
not
this
action
might
apply
to
certain
entities.
If
you
have
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
0211.
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/.
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
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17:
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Federal
Register
/
Vol.
67,
No.
235
/
Friday,
December
6,
2002
/
Notices
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.
Certain
types
of
information
will
not
be
placed
in
the
EPA
Dockets.
Information
claimed
as
CBI
and
other
information
whose
disclosure
is
restricted
by
statute,
which
is
not
included
in
the
official
public
docket,
will
not
be
available
for
public
viewing
in
EPA's
electronic
public
docket.
EPA's
policy
is
that
copyrighted
material
will
not
be
placed
in
EPA's
electronic
public
docket
but
will
be
available
only
in
printed,
paper
form
in
the
official
public
docket.
To
the
extent
feasible,
publicly
available
docket
materials
will
be
made
available
in
EPA's
electronic
public
docket.
When
a
document
is
selected
from
the
index
list
in
EPA
Dockets,
the
system
will
identify
whether
the
document
is
available
for
viewing
in
EPA's
electronic
public
docket.
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.
EPA
intends
to
work
towards
providing
electronic
access
to
all
of
the
publicly
available
docket
materials
through
EPA's
electronic
public
docket.
For
public
commenters,
it
is
important
to
note
that
EPA's
policy
is
that
public
comments,
whether
submitted
electronically
or
in
paper,
will
be
made
available
for
public
viewing
in
EPA's
electronic
public
docket
as
EPA
receives
them
and
without
change,
unless
the
comment
contains
copyrighted
material,
CBI,
or
other
information
whose
disclosure
is
restricted
by
statute.
When
EPA
identifies
a
comment
containing
copyrighted
material,
EPA
will
provide
a
reference
to
that
material
in
the
version
of
the
comment
that
is
placed
in
EPA's
electronic
public
docket.
The
entire
printed
comment,
including
the
copyrighted
material,
will
be
available
in
the
public
docket.
Public
comments
submitted
on
computer
disks
that
are
mailed
or
delivered
to
the
docket
will
be
transferred
to
EPA's
electronic
public
docket.
Public
comments
that
are
mailed
or
delivered
to
the
docket
will
be
scanned
and
placed
in
EPA's
electronic
public
docket.
Where
practical,
physical
objects
will
be
photographed,
and
the
photograph
will
be
placed
in
EPA's
electronic
public
docket
along
with
a
brief
description
written
by
the
docket
staff.
C.
How
and
To
Whom
Do
I
Submit
Comments?
You
may
submit
comments
electronically,
by
mail,
or
through
hand
delivery/
courier.
To
ensure
proper
receipt
by
EPA,
identify
the
appropriate
docket
ID
number
in
the
subject
line
on
the
first
page
of
your
comment.
Please
ensure
that
your
comments
are
submitted
within
the
specified
comment
period.
Comments
received
after
the
close
of
the
comment
period
will
be
marked
``
late.''
EPA
is
not
required
to
consider
these
late
comments.
If
you
wish
to
submit
CBI
or
information
that
is
otherwise
protected
by
statute,
please
follow
the
instructions
in
Unit
I.
D.
Do
not
use
EPA
Dockets
or
e
mail
to
submit
CBI
or
information
protected
by
statute.
1.
Electronically.
If
you
submit
an
electronic
comment
as
prescribed
in
this
unit,
EPA
recommends
that
you
include
your
name,
mailing
address,
and
an
email
address
or
other
contact
information
in
the
body
of
your
comment.
Also
include
this
contact
information
on
the
outside
of
any
disk
or
CD
ROM
you
submit,
and
in
any
cover
letter
accompanying
the
disk
or
CD
ROM.
This
ensures
that
you
can
be
identified
as
the
submitter
of
the
comment
and
allows
EPA
to
contact
you
in
case
EPA
cannot
read
your
comment
due
to
technical
difficulties
or
needs
further
information
on
the
substance
of
your
comment.
EPA's
policy
is
that
EPA
will
not
edit
your
comment,
and
any
identifying
or
contact
information
provided
in
the
body
of
a
comment
will
be
included
as
part
of
the
comment
that
is
placed
in
the
official
public
docket,
and
made
available
in
EPA's
electronic
public
docket.
If
EPA
cannot
read
your
comment
due
to
technical
difficulties
and
cannot
contact
you
for
clarification,
EPA
may
not
be
able
to
consider
your
comment.
i.
EPA
Dockets.
Your
use
of
EPA's
electronic
public
docket
to
submit
comments
to
EPA
electronically
is
EPA's
preferred
method
for
receiving
comments.
Go
directly
to
EPA
Dockets
at
http://
www.
epa.
gov/
edocket,
and
follow
the
online
instructions
for
submitting
comments.
Once
in
the
system,
select
``
search,''
and
then
key
in
docket
ID
number
OPP
2002
0211
The
system
is
an
``
anonymous
access''
system,
which
means
EPA
will
not
know
your
identity,
e
mail
address,
or
other
contact
information
unless
you
provide
it
in
the
body
of
your
comment.
ii.
E
mail.
Comments
may
be
sent
by
e
mail
to
opp
docket@
epa.
gov,
Attention:
Docket
ID
Number
OPP
2002
0211.
In
contrast
to
EPA's
electronic
public
docket,
EPA's
e
mail
system
is
not
an
``
anonymous
access''
system.
If
you
send
an
e
mail
comment
directly
to
the
docket
without
going
through
EPA's
electronic
public
docket,
EPA's
e
mail
system
automatically
captures
your
e
mail
address.
E
mail
addresses
that
are
automatically
captured
by
EPA's
e
mail
system
are
included
as
part
of
the
comment
that
is
placed
in
the
official
public
docket,
and
made
available
in
EPA's
electronic
public
docket.
iii.
Disk
or
CD
ROM.
You
may
submit
comments
on
a
disk
or
CD
ROM
that
you
mail
to
the
mailing
address
identified
in
Unit
I.
C.
2.
These
electronic
submissions
will
be
accepted
in
WordPerfect
or
ASCII
file
format.
Avoid
the
use
of
special
characters
and
any
form
of
encryption.
2.
By
mail.
Send
your
comments
to:
Public
Information
and
Records
Integrity
Branch
(
PIRIB)
(
7502C),
Office
of
Pesticide
Programs
(
OPP),
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460
0001,
Attention:
Docket
ID
Number
OPP
2002
0211.
3.
By
hand
delivery
or
courier.
Deliver
your
comments
to:
Public
Information
and
Records
Integrity
Branch
(
PIRIB),
Office
of
Pesticide
Programs
(
OPP),
Environmental
Protection
Agency,
Rm.
119,
Crystal
Mall
#
2,
1921
Jefferson
Davis
Hwy.,
Arlington,
VA,
Attention:
Docket
ID
Number
OPP
2002
0211.
Such
deliveries
are
only
accepted
during
the
docket's
normal
hours
of
operation
as
identified
in
Unit
I.
B.
1.
D.
How
Should
I
Submit
CBI
To
the
Agency?
Do
not
submit
information
that
you
consider
to
be
CBI
electronically
through
EPA's
electronic
public
docket
or
by
e
mail.
You
may
claim
information
that
you
submit
to
EPA
as
CBI
by
marking
any
part
or
all
of
that
information
as
CBI
(
if
you
submit
CBI
on
disk
or
CD
ROM,
mark
the
outside
of
the
disk
or
CD
ROM
as
CBI
and
then
identify
electronically
within
the
disk
or
CD
ROM
the
specific
information
that
is
CBI).
Information
so
marked
will
not
be
disclosed
except
in
accordance
with
procedures
set
forth
in
40
CFR
part
2.
In
addition
to
one
complete
version
of
the
comment
that
includes
any
information
claimed
as
CBI,
a
copy
of
the
comment
that
does
not
contain
the
information
claimed
as
CBI
must
be
submitted
for
inclusion
in
the
public
docket
and
EPA's
electronic
public
docket.
If
you
submit
the
copy
that
does
not
contain
CBI
on
disk
or
CD
ROM,
mark
the
outside
of
the
disk
or
CD
ROM
clearly
that
it
does
not
contain
CBI.
Information
not
marked
as
CBI
will
be
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Federal
Register
/
Vol.
67,
No.
235
/
Friday,
December
6,
2002
/
Notices
included
in
the
public
docket
and
EPA's
electronic
public
docket
without
prior
notice.
If
you
have
any
questions
about
CBI
or
the
procedures
for
claiming
CBI,
please
consult
the
person
listed
under
FOR
FURTHER
INFORMATION
CONTACT.
E.
What
Should
I
Consider
as
I
Prepare
My
Comments
for
EPA?
You
may
find
the
following
suggestions
helpful
for
preparing
your
comments:
1.
Explain
your
views
as
clearly
as
possible.
2.
Describe
any
assumptions
that
you
used.
3.
Provide
copies
of
any
technical
information
and/
or
data
you
used
that
support
your
views.
4
If
you
estimate
potential
burden
or
costs,
explain
how
you
arrived
at
the
estimate
that
you
provide.
5.
Provide
specific
examples
to
illustrate
your
concerns.
6.
Make
sure
to
submit
your
comments
by
the
deadline
in
this
notice.
7.
To
ensure
proper
receipt
by
EPA,
be
sure
to
identify
the
docket
ID
number
assigned
to
this
action
in
the
subject
line
on
the
first
page
of
your
response.
You
may
also
provide
the
name,
date,
and
Federal
Register
citation.
II.
What
Action
is
the
Agency
Taking?
EPA
has
received
a
pesticide
petition
as
follows
proposing
the
establishment
and/
or
amendment
of
regulations
for
residues
of
a
certain
pesticide
chemical
in
or
on
various
food
commodities
under
section
408
of
the
Federal
Food,
Drug,
and
Cosmetic
Act
(
FFDCA),
21
U.
S.
C.
346a.
EPA
has
determined
that
this
petition
contains
data
or
information
regarding
the
elements
set
forth
in
FFDCA
section
408(
d)(
2);
however,
EPA
has
not
fully
evaluated
the
sufficiency
of
the
submitted
data
at
this
time
or
whether
the
data
support
granting
of
the
petition.
Additional
data
may
be
needed
before
EPA
rules
on
the
petition.
List
of
Subjects
Environmental
protection,
Agricultural
commodities,
Feed
additives,
Food
additives,
Pesticides
and
pests,
Reporting
and
recordkeeping
requirements.
Dated:
November
27,
2002.
Donald
R.
Stubbs,
Acting
Director,
Registration
Division,
Office
of
Pesticide
Programs.
Summary
of
Petition
The
petitioner
summary
of
the
pesticide
petition
is
printed
below
as
required
by
FFDCA
section
408(
d)(
3).
The
summary
of
the
petition
was
prepared
by
the
petitioner
and
represents
the
view
of
the
petitioner.
The
petition
summary
announces
the
availability
of
a
description
of
the
analytical
methods
available
to
EPA
for
the
detection
and
measurement
of
the
pesticide
chemical
residues
or
an
explanation
of
why
no
such
method
is
needed.
BASF
Corporation
PP
6F4746
EPA
has
received
a
pesticide
petition
(
PP
6F4746)
from
BASF
Corporation,
26
Davis
Drive,
P.
O.
Box
13528,
Research
Triangle
Park,
North
Carolina
27709
3528,
proposing
pursuant
to
section
408(
d)
of
the
Federal
Food,
Drug
and
Cosmetic
Act
(
FFDCA),
21
U.
S.
C.
346a(
d),
to
amend
40
CFR
part
180
by
establishing
tolerances
for
the
sum
of
the
residues
of
the
herbicide
imazethapyr,
2[
4,5
dihydro
4
methyl
4
(
1
methylethyl)
5
oxo
1H
imidazol
2
yl]
5
ethyl
3
pyridine
carboxylic
acid)
as
its
free
acid
or
its
ammonium
salt
(
calculated
as
the
acid),
and
its
metabolite
2[
4,
5
dihydro
4
methyl
4
(
1
methylethyl
5
oxo
1H
imidazol
2
yl]
5(
1
hydroxyethyl)
3
pyridinecarboxylic
acid
both
free
and
conjugated
in
or
on
nongrass
animal
feed
crops,
forage,
hay
and
seed
at
3.0
parts
per
million
(
ppm).
EPA
has
determined
that
the
petition
contains
data
or
information
regarding
the
elements
set
forth
in
section
408(
d)(
2)
of
the
FFDCA;
however,
EPA
has
not
fully
evaluated
the
sufficiency
of
the
submitted
data
at
this
time
or
whether
the
data
supports
granting
of
the
petition.
Additional
data
may
be
needed
before
EPA
rules
on
the
petition.
A.
Residue
Chemistry
1.
Plant
metabolism.
The
qualitative
nature
of
the
residues
of
imazethapyr
in
clover
is
adequately
understood.
Based
on
studies
conducted
on
soybean,
edible
and
forage
legumes,
corn
and
canola,
parent
imazethapyr
and
common
metabolites
CL
288511
and
CL
182704
are
the
only
residues
of
concern
for
tolerance
setting
purposes.
2.
Analytical
method.
A
practical
analytical
method
for
detecting
and
measuring
imazethapyr
residues
of
concern
in
alfalfa
and
clover
commodities
was
submitted
to
EPA
with
the
alfalfa
petition.
The
analytical
method
for
alfalfa
and
clover
forage,
hay
and
seed
is
based
on
Capillary
Electrophoresis
(
CE)
with
limits
of
quantitation
(
LOQ)
of
0.50
ppm.
This
validated
method
was
approved
for
analysis
in
alfalfa
and
is
appropriate
for
the
enforcement
purposes
of
this
petition.
3.
Magnitude
of
residues.
A
total
of
twelve
field
trials
were
conducted
with
imazethapyr
and
its
metabolites
on
clover
to
demonstrate
the
residues
in
clover
forage,
hay
and
seed.
In
all
clover
residue
studies,
imazethapyr
was
applied
at
0.094
lb
ae/
A,
the
maximum
proposed
label
rate.
Clover
samples
were
cut
at
15
DAT
and
30
DAT,
the
proposed
preharvest
interval
(
PHI).
At
30
DAT,
all
forage
samples
contained
residues
of
imazethapyr
and
CL
288511
at
less
than
0.5
ppm.
In
most
30
DAT
forage
samples,
residues
of
CL
182704
were
below
the
LOQ
(
0.5
ppm).
No
hay
samples
had
residues
of
imazethapyr
above
the
LOQ
(
0.5
ppm).
There
was
only
one
hay
sample
containing
residues
of
CL
288511
above
the
LOQ.
In
all
cases,
for
the
15
and
30
DAT
forage
and
hay
samples,
the
primary
residue
was
CL
182704
(
the
glucose
conjugate
of
CL
288511).
Since
CL
182704
is
the
derivitized
form
of
CL
288511,
the
residues
were
converted
to
a
total
CL
288511
equivalent
residue
basis.
Seed
and
seed
screening
samples
were
collected
from
studies
conducted
at
two
sites.
In
both
studies,
residues
of
imazethapyr,
CL
288511
and
CL
182704
were
less
than
the
LOQ.
The
proposed
tolerance
for
nongrass
animal
feeds
is
3.0
ppm
for
imazethapyr,
CL
288511
and
the
glucose
conjugate,
CL
182704.
Residue
levels
of
imazethapyr
and
CL
288511
in
clover
are
all
below
the
proposed
tolerance.
When
residues
of
CL
182704
are
adjusted
to
CL
288511
equivalents
residues,
the
total
equivalent
CL
288511
residues
are
below
the
proposed
3.0
tolerance
level
in
all
clover
studies.
B.
Toxicological
Profile.
A
complete,
valid
and
reliable
database
of
mammalian
and
genetic
toxicology
studies
supports
the
proposed
tolerance
for
imazethapyr
on
nongrass
animal
feeds.
This
database
was
previously
reviewed
by
the
EPA
in
support
of
the
tolerance
petitions
and
registration
of
imazethapyr
on
soybeans,
legume
vegetables,
corn,
alfalfa
and
peanuts.
1.
Acute
toxicity.
Imazethapyr
technical
is
considered
to
be
nontoxic
(
Toxicity
Category
IV)
to
the
rat
by
the
oral
route
of
exposure.
In
an
acute
oral
toxicity
study
in
rats,
the
LD50
value
of
imazethapyr
technical
was
greater
than
5,000
milligrams/
kilogram/
body
weight
(
mg/
kg
b.
w.)
for
males
and
females.
The
results
from
an
acute
dermal
toxicity
study
in
rabbits
indicate
that
imazethapyr
is
slightly
toxic
(
Toxicity
Category
III)
to
rabbits
by
the
dermal
route
of
exposure.
The
dermal
LD50
value
of
imazethapyr
technical
was
greater
than
2,000
mg/
kg
b.
w.
for
both
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Federal
Register
/
Vol.
67,
No.
235
/
Friday,
December
6,
2002
/
Notices
male
and
female
rabbits.
Imazethapyr
technical
is
considered
to
be
non
toxic
(
Toxicity
Category
IV)
to
the
rat
by
the
respiratory
route
of
exposure.
The
4
hour
LC50
value
was
greater
than
3.27
mg/
l
(
analytical)
and
greater
than
4.21
mg/
l
(
gravimetric)
for
both
males
and
females.
Imazethapyr
technical
was
shown
to
be
non
irritating
to
rabbit
skin
(
Toxicity
Category
IV)
and
mildly
irritating
to
the
rabbit
eye
(
Toxicity
Category
III).
Based
on
the
results
of
a
dermal
sensitization
study
(
Buehler),
imazethapyr
technical
is
not
considered
a
sensitizer
in
guinea
pigs.
2.
Genotoxicity.
Imazethapyr
technical
was
tested
in
a
battery
of
four
in
vitro
and
one
in
vivo
genotoxicity
assays
measuring
several
different
endpoints
of
potential
genotoxicity.
Collective
results
from
these
studies
indicate
that
imazethapyr
does
not
pose
a
mutagenic
or
genotoxic
risk.
3.
Reproductive
and
developmental
toxicity.
The
developmental
toxicity
study
in
Sprague
Dawley
rats
conducted
with
imazethapyr
technical
showed
no
evidence
of
developmental
toxicity
or
teratogenic
effects
in
fetuses.
Thus,
imazethapyr
is
neither
a
developmental
toxicant
nor
a
teratogen
in
the
rat.
The
no
observed
adverse
effect
level
(
NOAEL)
for
maternal
toxicity
was
375
mg/
kg
b.
w./
day,
based
on
clinical
signs
of
toxicity
in
the
dams
(
e.
g.
excessive
salivation)
at
1,125
mg/
kg
b.
w./
day.
Imazethapyr
technical
did
not
exhibit
developmental
toxicity
or
teratogenic
effects
at
maternal
dosages
up
to
and
including
1,125
mg/
kg
b.
w./
day,
the
highest
dose
tested
(
HDT).
Results
from
a
developmental
toxicity
study
in
New
Zealand
White
rabbits
with
imazethapyr
technical
also
indicated
no
evidence
of
developmental
toxicity
or
teratogenicity.
Thus,
imazethapyr
technical
is
neither
a
developmental
toxicant
nor
a
teratogen
in
the
rabbit.
The
NOAEL
for
maternal
toxicity
was
300
mg/
kg
b.
w./
day,
based
on
decreased
food
consumption
and
body
weight
gain,
abortion,
gastric
ulceration
and
death
at
1,000
mg/
kg
b.
w./
day,
the
next
HDT.
The
NOAEL
for
developmental
toxicity
and
teratogenic
effects
was
determined
to
be
>
1,000
mg/
kg
b.
w./
day
based
on
no
developmental
toxicity
or
fetal
malformations
associated
with
the
administration
of
all
doses.
The
results
from
the
2
generation
reproduction
toxicity
study
in
rats
with
imazethapyr
technical
support
a
NOAEL
for
reproductive
toxicity
of
10,000
ppm
(
equivalent
to
800
mg/
kg
b.
w./
day).
The
NOAEL
for
non
reproductive
parameters
(
i.
e.
decreased
weanling
body
weights)
is
5,000
ppm.
4.
Subchronic
toxicity.
A
short
term
(
21
day)
dermal
toxicity
study
in
rabbits
was
conducted
with
imazethapyr
technical.
No
dermal
irritation
or
abnormal
clinical
signs
were
observed
at
dose
levels
up
to
and
including
1,000
mg/
kg
b.
w./
day
HDT,
supporting
a
NOAEL
for
dermal
irritation
and
systemic
toxicity
of
1,000
mg/
kg
b.
w./
day.
In
a
subchronic
(
13
week)
dietary
toxicity
study
in
rats
with
imazethapyr
technical,
no
signs
of
systemic
toxicity
were
noted,
supporting
a
NOAEL
of
10,000
ppm
the
highest
concentration
tested
(
HCT)
(
equivalent
to
820
mg/
kg
b.
w./
day).
In
a
subchronic
(
13
week)
dietary
toxicity
study
in
dogs
with
imazethapyr
technical,
no
signs
of
systemic
toxicity
were
noted,
supporting
a
NOAEL
of
10,000
ppm
(
equivalent
to
250
mg/
kg
b.
w./
day),
the
(
HCT).
5.
Chronic
toxicity.
A
1
year
dietary
toxicity
study
was
conducted
with
imazethapyr
technical
in
Beagle
dogs
at
dietary
concentrations
of
0,
1,000,
5,000
and
10,000
ppm.
In
this
study,
the
NOAEL
for
systemic
toxicity
was
1,000
ppm
(
equivalent
to
25
mg/
kg
b.
w./
day),
based
on
slight
anemia,
i.
e.,
decreased
red
cell
parameters
observed
at
5,000
and
10,000
ppm
concentrations.
No
treatment
related
histopathological
lesions
were
observed
at
any
dietary
concentration,
including
the
HCT
(
10,000
ppm).
In
a
2
year
chronic
dietary
oncogenicity
and
toxicity
study
in
rats
conducted
with
imazethapyr
technical,
the
NOAEL
for
oncogenicity
and
chronic
systemic
toxicity
was
10,000
ppm
(
equivalent
to
500
mg/
kg
b.
w./
day),
the
HCT.
An
18
month
chronic
dietary
oncogenicity
and
toxicity
study
in
mice
with
imazethapyr
technical
supports
a
NOAEL
for
oncogenicity
of
10,000
ppm,
the
HCT
(
equivalent
to
1,500
mg/
kg
b.
w./
day),
and
a
NOAEL
for
chronic
systemic
toxicity
of
5,000
ppm
(
equivalent
to
750
mg/
kg
b.
w./
day),
based
on
decreased
body
weight
gain
in
both
sexes).
The
EPA
has
classified
imazethapyr
as
negative
for
carcinogenicity
(
evidence
of
non
carcinogenicity
for
humans)
based
on
the
absence
of
treatmentrelated
tumors
in
acceptable
carcinogenicity
studies
in
both
rats
and
mice.
6.
Animal
metabolism.
The
rat,
goat
and
hen
metabolism
studies
indicate
that
the
qualitative
nature
of
the
residues
of
imazethapyr
in
animals
is
adequately
understood.
In
three
rat
metabolism
studies
conducted
with
radiolabeled
imazethapyr
technical
the
major
route
of
elimination
of
the
herbicide
was
through
rapid
excretion
in
urine
and
to
a
much
lesser
extent
in
feces.
In
the
first
study,
almost
100%
of
the
administered
material
was
recovered
in
excreta
within
96
hours
(
89
95%
in
urine,
6
11%
in
feces).
The
major
residue
in
urine
and
feces
was
parent
compound.
Approximately
2%
of
the
dose
was
metabolized
and
excreted
as
the
ahydroxyethyl
derivative
of
imazethapyr.
In
the
second
study,
the
test
material
was
rapidly
and
completely
eliminated
unchanged
in
the
urine
within
72
hours
of
dosing.
After
24
hours,
92.1%
of
radioactivity
was
excreted
in
the
urine
with
4.67%
in
the
feces.
There
was
no
significant
bioaccumulation
of
radioactivity
in
the
tissues
from
this
rat
metabolism
study
(<
0.01
ppm
after
24
hours).
In
the
third
study,
four
groups
treated
with
radiolabeled
imazethapyr
readily
excreted
>
95%
of
the
test
material
in
the
urine
and
feces
within
48
hours.
A
high
percentage
(
97
99%)
of
the
test
material
was
excreted
in
the
urine
as
unchanged
parent,
the
remainder
as
the
a
hydroxyethyl
derivative
of
imazethapyr.
For
all
three
studies,
the
major
route
of
elimination
of
the
herbicide
in
rats
was
through
rapid
excretion
of
unchanged
parent
compound
in
urine.
It
is
clear
that
imazathapyr
and
its
related
residues
do
not
accumulate
in
tissues
and
organs.
In
the
goat
metabolism
study,
parent
14Cimazethapyr
was
dosed
to
lactating
goats
at
0.25
ppm
and
1.25
ppm.
Results
showed
14C
residues
of
<
0.01
ppm
in
milk
and
<
0.05
ppm
in
leg
muscle,
loin
muscle,
blood,
fat,
liver
and
kidney.
Laying
hens
dosed
at
0.5
ppm
and
2.5
ppm
with
14C
imazethapyr
showed
14Cresidues
of
<
0.05
ppm
in
eggs
and
all
tissues
(
blood,
muscle,
skin/
fat,
liver
and
kidney).
Additional
animal
metabolism
studies
have
been
conducted
with
CL
288511
(
main
metabolite
in
treated
crops
fed
to
livestock)
in
both
laying
hens
and
lactating
goats.
These
studies
have
been
repeated
to
support
subsequent
use
extensions
on
crops
used
as
livestock
feed
items
which
would
theoretically
result
in
a
higher
dosing
of
imazethapyr
derived
residues
to
livestock
(
i.
e.,
corn,
alfalfa).
In
these
studies,
lactating
goats
dosed
at
42
ppm
of
14C
CL
288511
showed
14C
residues
of
<
0.01
ppm
in
milk,
leg
muscle,
loin
muscle
and
omental
fat.
14C
Residues
in
blood
were
mostly
<
0.01
ppm
but
reached
0.01
ppm
on
two
of
the
treatment
days.
14CResidue
levels
in
the
liver
and
kidney
were
0.02
and
0.09
ppm,
respectively.
Laying
hens
dosed
at
10.2
ppm
of
14Cimazethapyr
showed
14C
residues
of
<
0.01
ppm
in
eggs
and
all
tissues
(
blood,
muscle,
skin/
fat,
liver
and
kidney).
14Cimazethapyr
or
14C
CL
288511
ingested
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Vol.
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/
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2002
/
Notices
by
either
laying
hens
or
lactating
goats
was
excreted
within
48
hours
of
dosing.
These
studies
indicate
that
parent
imazethapyr
and
CL
288511
related
residues
do
not
accumulate
in
milk
or
edible
tissues
of
the
ruminant.
7.
Metabolite
toxicology.
Metabolism
studies
in
soybean,
peanut,
corn,
alfalfa
and
canola
indicate
that
the
only
significant
metabolites
are
the
ahydroxyethyl
derivative
of
imazethapyr,
CL
288511
and
its
glucose
conjugate
CL
182704.
The
a
hydroxyethyl
metabolite
has
also
been
identified
in
minor
quantities
in
the
previously
submitted
rat
metabolism
studies
and
in
goat
and
hen
metabolism
studies.
No
additional
toxicologically
significant
metabolites
were
detected
in
any
of
the
plant
or
animal
metabolism
studies.
8.
Endocrine
disruption.
Collective
organ
weight
data
and
histopathological
findings
from
the
2
generation
rat
reproductive
study,
as
well
as
from
the
subchronic
and
chronic
toxicity
studies
in
three
different
animal
species
demonstrate
no
apparent
estrogenic
effects
or
treatment
related
effects
of
imazethapyr
on
the
endocrine
system.
C.
Aggregate
Exposure
1.
Dietary
exposure.
The
potential
dietary
exposure
to
imazethapyr
has
been
calculated
from
the
proposed
tolerance
for
use
on
rice
and
previously
established
tolerances
for
peanuts,
legume
vegetables,
soybeans,
alfalfa,
endive,
lettuce,
and
corn.
This
very
conservative
chronic
dietary
exposure
estimate
used
the
proposed
tolerance
of
0.5
parts
per
million
(
ppm)
for
rice,
and
tolerance
values
of
0.1
ppm
for
peanuts,
0.1
ppm
for
legume
vegetables,
0.1
ppm
for
soybeans,
3.0
ppm
for
alfalfa,
0.1
ppm
for
endive
(
escarole),
0.1
ppm
for
lettuce,
and
0.1
ppm
for
corn.
In
addition,
these
estimates
assume
that
100%
of
these
crops
contain
imazethapyr
residues.
In
support
of
this
tolerance
petition,
a
proposed
tolerance
of
3.0
ppm
for
nongrass
animal
feeds
would
not
be
expected
to
contribute
significantly
to
this
dietary
risk
assessment.
2.
Food.
Potential
exposure
to
residues
of
imazethapyr
in
food
will
be
restricted
to
intake
of
rice,
peanuts,
legume
vegetables,
soybeans,
alfalfa
(
sprouts),
endive,
lettuce,
and
corn.
Using
the
assumptions
discussed
above,
the
Theoretical
Maximum
Residue
Concentration
(
TMRC)
values
of
imazethapyr
were
calculated
for
the
U.
S.
general
population
and
subgroups.
Based
on
the
tolerances
given
above,
the
TMRC
values
for
each
group
are:
0.000419
mg/
kg
b.
w./
day
for
the
general
U.
S.
population.
0.001104
mg/
kg
b.
w./
day
for
all
infants
(>
1
year).
0.001298
mg/
kg
b.
w./
day
for
nonnursing
infants.
0.000870
mg/
kg
b.
w./
day
for
children
1
to
6
years
of
age.
0.000610
mg/
kg
b.
w./
day
for
children
7
to
12
years
of
age.
The
TMRC
values
indicate
that
nonnursing
infants
are
the
most
highly
exposed
population
subgroup.
3.
Drinking
water.
As
a
screeninglevel
assessment
for
aggregate
exposure,
the
U.
S.
EPA
evaluates
a
drinking
water
level
of
comparison
(
DWLOC),
which
is
the
maximum
concentration
of
a
chemical
in
drinking
water
that
would
be
acceptable
in
light
of
total
aggregate
exposure
to
that
chemical.
In
1990,
the
EPA
set
the
reference
dose
(
RfD)
for
imazethapyr
at
0.25
mg/
kg
b.
w./
day,
based
on
the
NOAEL
from
the
1
year
dietary
toxicity
study
in
dogs
of
25
mg/
kg
b.
w./
day
and
a
100
fold
uncertainty
factor.
Based
on
the
cRfD
of
0.25
mg/
kg
b.
w./
day
and
the
EPA's
default
factors
for
body
weight
and
drinking
water
consumption,
the
DWLOCs
have
been
calculated
to
assess
the
potential
dietary
exposure
from
residues
of
imazethapyr
in
water.
For
the
adult
population
the
chronic
DWLOC
was
8735
ppb
and
for
children
the
DWLOC
was
estimated
to
be
2491
parts
per
billion
(
ppb).
Chronic
drinking
water
exposure
analyses
were
calculated
for
imazethapyr
using
EPA
screening
concentration
in
ground
water
(
SCIGROW
and
genetic
expected
environmental
concentration
(
GENEEC)
for
surface
water.
The
SCI
GROW
value
is
16.54
ppb
and
the
calculated
peak
GENEEC
value
is
5.96
ppb
by
aerial
application.
For
the
U.
S.
adult
population,
the
estimated
exposures
of
imazethapyr
residues
in
ground
water
and
surface
water
are
approximately
0.19%
and
0.07%,
respectively,
of
the
DWLOC.
The
estimated
exposures
of
children
to
imazethapyr
residues
in
groundwater
and
surface
water
are
approximately
0.66%,
and
0.24%,
respectively,
of
the
DWLOC.
Therefore,
the
exposures
to
drinking
water
from
imazethapyr
use
are
negligible.
4.
Non
dietary
exposure.
Imazethapyr
products
are
not
currently
registered
or
requested
to
be
registered
for
residential
use;
therefore
the
estimate
of
residential
exposure
is
not
relevant
to
this
tolerance
petition.
D.
Cumulative
Effects
Imazethapyr
is
a
member
of
the
imidazolinone
class
of
herbicides.
Other
compounds
of
this
class
are
registered
for
use
in
the
U.
S.
However,
the
herbicidal
activity
of
the
imidazolinones
is
due
to
the
inhibition
of
acetohydroxyacid
synthase
(
AHAS),
an
enzyme
only
found
in
plants.
AHAS
is
part
of
the
biosynthetic
pathway
leading
to
the
formation
of
branched
chain
amino
acids.
Animals
lack
AHAS
and
this
biosynthetic
pathway.
This
lack
of
AHAS
contributes
to
the
low
toxicity
of
the
imidazolinone
compounds
in
animals.
We
are
aware
of
no
information
to
indicate
or
suggest
that
imazethapyr
has
any
toxic
effects
on
mammals
that
would
be
cumulative
with
those
of
any
other
chemical.
Therefore,
for
the
purposes
of
this
tolerance
petition
no
assumption
has
been
made
with
regard
to
cumulative
exposure
with
other
compounds
having
a
common
mode
of
action.
E.
Safety
Determination
1.
U.
S.
population.
The
RfD
represents
the
level
at
or
below
which
daily
aggregate
exposure
over
a
lifetime
will
not
pose
appreciable
risks
to
human
health.
In
1990,
the
EPA
set
the
RfD
for
imazethapyr
at
0.25
mg/
kg
b.
w./
day,
based
on
the
NOAEL
from
the
1
year
dietary
toxicity
study
in
dogs
of
25
mg/
kg
b.
w./
day
and
a
100
fold
uncertainty
factor.
The
chronic
dietary
exposure
of
0.000419
mg/
kg
b.
w./
day
for
the
general
U.
S.
population
will
utilize
only
0.2%
of
the
RfD
of
0.25
mg/
kg
b.
w./
day.
EPA
generally
has
no
concern
for
exposures
below
100%
of
the
RfD.
Due
to
the
low
toxicity
of
imazethapyr,
an
acute
exposure
dietary
risk
assessment
is
not
warranted.
The
complete
and
reliable
toxicity
database,
the
low
toxicity
of
the
active
ingredient,
and
the
results
of
the
chronic
dietary
exposure
risk
assessment
support
the
conclusion
that
there
is
a
``
reasonable
certainty
of
no
harm''
from
the
proposed
use
of
imazethapyr
on
imidazolinone
tolerant
rice,
canola
and
nongrass
animal
feeds.
2.
Infants
and
children.
The
conservative
dietary
exposure
estimates
of
all
registered
uses
including
the
proposed
tolerance
for
rice
show
exposures
of
0.001104,
0.000440,
0.000870,
and
0.000610
mg/
kg
b.
w./
day
which
will
utilize
0.4,
0.2,
0.3,
and
0.2%
of
the
RfD
for
all
infants
(<
1
year),
nursing
infants,
children
1
6
years,
and
children
7
12
years,
respectively.
The
chronic
dietary
exposures
for
nonnursing
infants,
the
most
highly
exposed
subgroup,
will
utilize
only
0.5%
of
the
RfD.
Results
from
the
2
generation
reproduction
study
in
rats
and
the
developmental
toxicity
studies
in
rabbits
and
rats
indicate
no
increased
sensitivity
to
developing
offspring
when
compared
to
parental
toxicity.
These
results
also
indicate
that
imazethapyr
is
neither
a
developmental
toxicant
nor
a
teratogen
in
either
the
rat
or
rabbit.
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/
Vol.
67,
No.
235
/
Friday,
December
6,
2002
/
Notices
Therefore,
an
additional
safety
factor
is
not
warranted,
and
the
RfD
of
0.25
mg/
kg
b.
w./
day,
which
utilizes
a
100
fold
safety
factor
is
appropriate
to
ensure
a
reasonable
certainty
of
no
harm
to
infants
and
children.
F.
International
Tolerances
There
are
no
Codex
maximum
residue
levels
established
or
proposed
for
residues
of
imazethapyr
on
nongrass
animal
feeds.
[
FR
Doc.
02
30947
Filed
12
5
02;
8:
45
a.
m.]
BILLING
CODE
6560
50
S
ENVIRONMENTAL
PROTECTION
AGENCY
[
FRL
7419
2]
Alaric,
Inc.
Superfund
Site;
Notice
of
Proposed
Settlement
AGENCY:
Environmental
Protection
Agency
(
EPA).
ACTION:
Notice
of
proposed
administrative
order
on
consent.
SUMMARY:
The
United
States
Environmental
Protection
Agency
is
proposing
to
enter
into
an
administrative
order
on
consent,
pursuant
to
section
122(
h)
of
the
Comprehensive
Environmental
Response,
Compensation,
and
Liability
Act
of
1980
(
CERCLA),
as
amended,
regarding
the
Alaric,
Inc.
Superfund
Site,
located
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Tampa,
Hillsborough
County,
Florida,
with
the
following
parties:
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W.
Oglesby,
Sr.
and
Carolyn
M.
Oglesby,
as
individuals;
the
Lee
W.
Oglesby,
Sr.
Living
Trust,
dated
September
22,
1998,
as
amended;
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W.
Oglesby,
Sr.,
as
trustee
and
beneficiary
of
the
Lee
W.
Oglesby,
Sr.
Living
Trust,
dated
September
22,
1998,
as
amended;
and
successor
trustees
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the
Lee
W.
Oglesby,
Sr.
Living
Trust,
dated
September
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1998,
as
amended.
The
settlement
is
designed
to
resolve
fully
each
settling
party's
liability
at
the
Site
through
a
covenant
not
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sue
under
sections
106
and
107(
a)
of
CERCLA,
42
U.
S.
C.
9606
and
9607(
a),
and
provide
contribution
protection.
EPA
will
consider
public
comments
on
the
proposed
settlement
within
thirty
(
30)
days
of
publication
of
this
notice.
EPA
may
withdraw
from
or
modify
the
proposed
settlement
should
such
comments
disclose
facts
or
considerations
which
indicate
the
proposed
settlement
is
inappropriate,
improper,
or
inadequate.
Copies
of
the
proposed
settlement
are
available
from:
Ms.
Paula
V.
Batchelor,
U.
S.
EPA,
Region
4
(
WMD
CPSB),
Sam
Nunn
Atlanta
Federal
Center,
Waste
Management
Division,
CERCLA
Program
Services
Branch,
61
Forsyth
Street,
SW.,
Atlanta,
Georgia
30303,
(
404)
562
8887.
Written
comments
may
be
submitted
to
Ms.
Batchelor
within
thirty
(
30)
calendar
days
of
the
date
of
this
publication.
Dated:
November
20,
2002.
Anita
L.
Davis,
Acting
Chief,
CERCLA
Program
Services
Branch,
Waste
Management
Division.
[
FR
Doc.
02
30942
Filed
12
5
02;
8:
45
am]
BILLING
CODE
6560
50
P
FEDERAL
COMMUNICATIONS
COMMISSION
[
Report
No.
AUC
02
48
A
(
Auction
No.
48);
DA
02
1441]
Auction
of
Licenses
for
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Lower
and
Upper
Paging
Bands
Scheduled
for
May
13,
2003;
Comment
Sought
on
Reserve
Prices
or
Minimum
Opening
Bids
and
Other
Auction
Procedures
AGENCY:
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ACTION:
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SUMMARY:
This
document
announces
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auction
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DATES:
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2002,
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2002.
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152
159
MHz,
454
460
MHz)
and
1,328
licenses
in
the
upper
paging
bands
(
929
931
MHz)
scheduled
to
commence
on
May
13,
2003
(``
Auction
No.
48'').
This
auction
will
include
licenses
that
remained
unsold
from
a
previous
auction
or
were
defaulted
on
by
a
winning
bidder
in
a
previous
auction.
Due
to
the
large
volume
of
licenses
in
Auction
No.
48,
the
complete
list
of
licenses
available
for
this
auction
will
be
provided
in
electronic
format
only,
available
as
``
Attachment
A''
to
the
Auction
No.
48
Comment
Public
Notice
at
http://
wireless.
fcc.
gov/
auctions/
48/.
2.
In
the
Paging
Reconsideration
Order,
64
FR
33762
(
June
24,
1999),
the
Commission
concluded
that
the
lower
bands
licenses
should
be
awarded
in
each
of
the
175
geographic
areas
known
as
Economic
Areas
(
EAs),
and
the
upper
band
licenses
should
be
awarded
in
each
of
the
51
geographic
areas
known
as
Major
Economic
Areas
(
MEAs).
These
EAs
and
MEAs
both
encompass
the
United
States,
Guam
and
Northern
Mariana
Islands,
Puerto
Rico
and
the
United
States
Virgin
Islands,
and
American
Samoa.
3.
The
following
tables
contain
the
Block/
Frequency
Cross
Reference
List
for
the
paging
bands:
VerDate
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| epa | 2024-06-07T20:31:43.206632 | regulations | {
"license": "Public Domain",
"url": "https://downloads.regulations.gov/EPA-HQ-OPP-2002-0211-0001/content.txt"
} |
EPA-HQ-OPP-2002-0214-0001 | Notice | "2002-09-25T04:00:00" | Notice of Filing a Pesticide Petition to Establish a Tolerance for a Certain Pesticide Chemical in or on
Food. | 60233
Federal
Register
/
Vol.
67,
No.
186
/
Wednesday,
September
25,
2002
/
Notices
Under
FIFRA,
as
amended
in
1988,
EPA
is
conducting
an
accelerated
reregistration
program
to
reevaluate
existing
pesticides
to
make
sure
they
meet
current
scientific
and
regulatory
standards.
The
data
base
to
support
the
reregistration
of
diazinon
is
substantially
complete.
Taking
into
account
both
the
risks
and
benefits
of
diazinon
uses,
the
Agency
has
determined
that
with
the
adoption
of
all
the
mitigation
measures
recommended
in
the
IRED,
use
of
diazinon
will
not
pose
unreasonable
adverse
risks
to
people
or
the
environment
when
used
according
to
its
currently
approved
labeling.
Please
note
that
this
is
only
an
interim
decision.
Upon
the
Agency's
completion
of
its
assessment
of
the
cumulative
risk
posed
by
the
organophosphates
as
a
class,
EPA
will
issue
a
final
reregistration
eligibility
decision
on
pesticides
containing
diaizinon.
All
registrants
of
pesticide
products
containing
diazinon
will
be
sent
the
appropriate
REDs,
labeling
requirements
and
product
specific
data
requirements
pending
OMB
approval
of
the
diazinon
Data
Call
In.
The
reregistration
program
is
being
conducted
under
Congressionally
mandated
time
frames,
and
EPA
recognizes
both
the
need
to
make
timely
reregistration
decisions
and
to
involve
the
public.
Therefore,
EPA
is
issuing
this
IRED
with
a
60
day
comment
period.
The
comment
period
is
intended
to
provide
an
opportunity
for
public
input
and
a
mechanism
for
initiating
any
necessary
amendment
to
the
IRED.
EPA
invites
comment
specifically
on
the
use
of
the
diazinon
benefit
assessments
which
can
be
found
with
the
diazinon
documents
on
the
EPA's
website
at
http://
www.
epa.
gov/
pesticides/
reregistration/
status.
htm.
All
comments
will
be
carefully
considered
by
the
Agency.
If
any
comment
significantly
affects
this
IRED,
EPA
will
amend
the
IRED
by
publishing
the
amendment
in
the
Federal
Register.
B.
What
is
the
Agency's
Authority
for
Taking
this
Action?
The
legal
authority
for
this
IRED
falls
under
FIFRA,
as
amended
in
1988
and
1996.
Section
4(
g)(
2)(
A)
of
FIFRA
directs
that,
after
submission
of
all
data
concerning
a
pesticide
active
ingredient,
``
the
Administrator
shall
determine
whether
pesticides
containing
such
active
ingredient
are
eligible
for
reregistration,
''
before
calling
in
product
specific
data
on
individual
end
use
products,
and
either
reregistering
products
or
taking
``
other
appropriate
regulatory
action.
''
List
of
Subjects
Environmental
protection,
Chemicals,
Pesticides
and
pests.
Dated:
September
13,
2002.
Lois
Ann
Rossi,
Director,
Special
Review
and
Reregistration
Division,
Office
of
Pesticide
Programs.
[FR
Doc.
02Ð
24231
Filed
9Ð
24Ð
02;
8:
45
am]
BILLING
CODE
6560–
50–
S
ENVIRONMENTAL
PROTECTION
AGENCY
[OPP–
2002–
0214;
FRL–
7194–
1]
Notice
of
Filing
a
Pesticide
Petition
to
Establish
a
Tolerance
fora
Certain
Pesticide
Chemical
in
or
on
Food
AGENCY:
Environmental
Protection
Agency
(EPA).
ACTION:
Notice.
SUMMARY:
This
notice
announces
the
initial
filing
of
a
pesticide
petition
proposing
the
establishment
of
regulations
for
residues
of
a
certain
pesticide
chemical
in
or
on
various
food
commodities.
DATES:
Comments,
identified
by
docket
ID
number
OPPÐ
2002Ð
0214,
must
be
received
on
or
before
October
25,
2002.
ADDRESSES:
Comments
may
be
submitted
by
mail,
electronically,
or
in
person.
Please
follow
the
detailed
instructions
for
each
method
as
provided
in
Unit
I.
C.
of
the
SUPPLEMENTARY
INFORMATION.
To
ensure
proper
receipt
by
EPA,
it
is
imperative
that
you
identify
docket
ID
number
OPPÐ
2002Ð
0214
in
the
subject
line
on
the
first
page
of
your
response.
FOR
FURTHER
INFORMATION
CONTACT:
By
mail:
Andrew
Bryceland,
Biochemical
Pesticides
Branch,
Biopesticides
and
Pollution
Prevention
Division
(7511C),
Office
of
Pesticide
Programs,
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460;
telephone
number:
(703)
305Ð
6928;
e
mail
address;
bryceland.
andrew@
epa.
gov.
SUPPLEMENTARY
INFORMATION:
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:
Categories
NAICS
codes
Examples
of
potentially
affected
entities
Industry
111
Crop
production
112
Animal
production
311
Food
manufacturing
32532
Pesticide
manufacturing
This
listing
is
not
intended
to
be
exhaustive,
but
rather
provides
a
guide
for
readers
regarding
entities
likely
to
be
affected
by
this
action.
Other
types
of
entities
not
listed
in
the
table
could
also
be
affected.
The
North
American
Industrial
Classification
System
(NAICS)
codes
have
been
provided
to
assist
you
and
others
in
determining
whether
or
not
this
action
might
apply
to
certain
entities.
If
you
have
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
Additional
Information,
Including
Copies
of
this
Document
and
Other
Related
Documents?
1.
Electronically.
You
may
obtain
electronic
copies
of
this
document,
and
certain
other
related
documents
that
might
be
available
electronically,
from
the
EPA
Internet
Home
Page
at
http://
www.
epa.
gov/.
To
access
this
document,
on
the
Home
Page
select
``
Laws
and
Regulations,
''
``
Regulations
and
Proposed
Rules,
''
and
then
look
up
the
entry
for
this
document
under
the
``
Federal
RegisterÑ
Environmental
Documents.
''
You
can
also
go
directly
to
the
Federal
Register
listings
at
http://
www.
epa.
gov/
fedrgstr/.
2.
In
person.
The
Agency
has
established
an
official
record
for
this
action
under
docket
ID
number
OPPÐ
2002Ð
0214.
The
official
record
consists
of
the
documents
specifically
referenced
in
this
action,
any
public
comments
received
during
an
applicable
comment
period,
and
other
information
related
to
this
action,
including
any
information
claimed
as
confidential
business
information
(CBI).
This
official
record
includes
the
documents
that
are
physically
located
in
the
docket,
as
well
as
the
documents
that
are
referenced
in
those
documents.
The
public
version
of
the
official
record
does
not
include
any
information
claimed
as
CBI.
The
public
version
of
the
official
record,
which
includes
printed,
paper
versions
of
any
electronic
comments
submitted
during
an
applicable
comment
period,
is
available
for
inspection
in
the
Public
Information
and
Records
Integrity
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Federal
Register
/
Vol.
67,
No.
186
/
Wednesday,
September
25,
2002
/
Notices
Branch
(PIRIB),
Rm.
119,
Crystal
Mall
#2,
1921
Jefferson
Davis
Highway,
Arlington,
VA,
from
8:
30
a.
m.
to
4
p.
m.,
Monday
through
Friday,
excluding
legal
holidays.
The
PIRIB
telephone
number
is
(703)
305Ð
5805.
C.
How
and
to
Whom
Do
I
Submit
Comments?
You
may
submit
comments
through
the
mail,
in
person,
or
electronically.
To
ensure
proper
receipt
by
EPA,
it
is
imperative
that
you
identify
docket
ID
number
OPPÐ
2002Ð
0214
in
the
subject
line
on
the
first
page
of
your
response.
1.
By
mail.
Submit
your
comments
to:
Public
Information
and
Records
Integrity
Branch
(PIRIB),
Information
Resources
and
Services
Division
(7502C),
Office
of
Pesticide
Programs
(OPP),
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460.
2.
In
person
or
by
courier.
Deliver
your
comments
to:
Public
Information
and
Records
Integrity
Branch
(PIRIB),
Information
Resources
and
Services
Division
(7502C),
Office
of
Pesticide
Programs
(OPP),
Environmental
Protection
Agency,
Rm.
119,
Crystal
Mall
#2,
1921
Jefferson
Davis
Highway,
Arlington,
VA.
The
PIRIB
is
open
from
8:
30
a.
m.
to
4
p.
m.,
Monday
through
Friday,
excluding
legal
holidays.
The
PIRIB
telephone
number
is
(703)
305Ð
5805.
3.
Electronically.
You
may
submit
your
comments
electronically
by
e
mail
to:
opp
docket@
epa.
gov,
or
you
can
submit
a
computer
disk
as
described
above.
Do
not
submit
any
information
electronically
that
you
consider
to
be
CBI.
Avoid
the
use
of
special
characters
and
any
form
of
encryption.
Electronic
submissions
will
be
accepted
in
Wordperfect
6.1/
8.0
or
ASCII
file
format.
All
comments
in
electronic
form
must
be
identified
by
docket
ID
number
OPPÐ
2002Ð
0214.
Electronic
comments
may
also
be
filed
online
at
many
Federal
Depository
Libraries.
D.
How
Should
I
Handle
CBI
That
I
Want
to
Submit
to
the
Agency?
Do
not
submit
any
information
electronically
that
you
consider
to
be
CBI.
You
may
claim
information
that
you
submit
to
EPA
in
response
to
this
document
as
CBI
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.
In
addition
to
one
complete
version
of
the
comment
that
includes
any
information
claimed
as
CBI,
a
copy
of
the
comment
that
does
not
contain
the
information
claimed
as
CBI
must
be
submitted
for
inclusion
in
the
public
version
of
the
official
record.
Information
not
marked
confidential
will
be
included
in
the
public
version
of
the
official
record
without
prior
notice.
If
you
have
any
questions
about
CBI
or
the
procedures
for
claiming
CBI,
please
consult
the
person
identified
under
FOR
FURTHER
INFORMATION
CONTACT.
E.
What
Should
I
Consider
as
I
Prepare
My
Comments
for
EPA?
You
may
find
the
following
suggestions
helpful
for
preparing
your
comments:
1.
Explain
your
views
as
clearly
as
possible.
2.
Describe
any
assumptions
that
you
used.
3.
Provide
copies
of
any
technical
information
and/
or
data
you
used
that
support
your
views.
4.
If
you
estimate
potential
burden
or
costs,
explain
how
you
arrived
at
the
estimate
that
you
provide.
5.
Provide
specific
examples
to
illustrate
your
concerns.
6.
Make
sure
to
submit
your
comments
by
the
deadline
in
this
notice.
7.
To
ensure
proper
receipt
by
EPA,
be
sure
to
identify
the
docket
control
number
assigned
to
this
action
in
the
subject
line
on
the
first
page
of
your
response.
You
may
also
provide
the
name,
date,
and
Federal
Register
citation.
II.
What
Action
is
the
Agency
Taking?
EPA
has
received
a
pesticide
petition
as
follows
proposing
the
establishment
and/
or
amendment
of
regulations
for
residues
of
a
certain
pesticide
chemical
in
or
on
various
food
commodities
under
section
408
of
the
Federal
Food,
Drug,
and
Cosmetic
Act
(FFDCA),
21
U.
S.
C.
346a.
EPA
has
determined
that
this
petition
contains
data
or
information
regarding
the
elements
set
forth
in
section
408(
d)(
2);
however,
EPA
has
not
fully
evaluated
the
sufficiency
of
the
submitted
data
at
this
time
or
whether
the
data
support
granting
of
the
petition.
Additional
data
may
be
needed
before
EPA
rules
on
the
petition.
List
of
Subjects
Environmental
protection,
Agricultural
commodities,
Feed
additives,
Food
additives,
Pesticides
and
pests,
Reporting
and
recordkeeping
requirements.
Dated:
September
16,
2002.
Janet
L.
Andersen,
Director,
Biopesticides
and
Pollution
Prevention
Division,
Office
of
Pesticides
Programs.
Summary
of
Petition
The
petitioner
summary
of
the
pesticide
petition
is
printed
below
as
required
by
section
408(
d)(
3)
of
the
FFDCA.
The
summary
of
the
petition
was
prepared
by
Certis
USA
LLC
and
represents
the
view
of
Certis
USA
LLC.
EPA
is
publishing
the
petition
summary
verbatim
without
editing
it
in
any
way.
The
petition
summary
announces
the
availability
of
a
description
of
the
analytical
methods
available
to
EPA
for
the
detection
and
measurement
of
the
pesticide
chemical
residues
or
an
explanation
of
why
no
such
method
is
needed.
Certis
USA
LLC
PP
2F6477
EPA
has
received
a
pesticide
petition
[2F6477]
from
Certis
USA
LLC
9145
Guild
Road,
Suite
175,
Columbia,
MD
21046,
proposing
pursuant
to
section
408(
d)
of
the
Federal
Food,
Drug,
and
Cosmetic
Act
(FFDCA),
21
U.
S.
C.
346a(
d),
to
amend
40
CFR
part
180
to
establish
an
exemption
from
the
requirement
of
a
tolerance
for
the
biochemical
pesticide
ammonium
bicarbonate.
Pursuant
to
section
408(
d)(
2)(
A)(
i)
of
the
FFDCA,
as
amended,
Certis
USA
LLC
has
submitted
the
following
summary
of
information,
data,
and
arguments
in
support
of
their
pesticide
petition.
This
summary
was
prepared
by
Certis
USA
LLC
and
EPA
has
not
fully
evaluated
the
merits
of
the
pesticide
petition.
The
summary
may
have
been
edited
by
EPA
if
the
terminology
used
was
unclear,
the
summary
contained
extraneous
material,
or
the
summary
unintentionally
made
the
reader
conclude
that
the
findings
reflected
EPA's
position
and
not
the
position
of
the
petitioner.
A.
Product
Name
and
Proposed
Use
Practices
1.
The
biochemical
ammonium
bicarbonate
is
proposed
for
use
as
an
insect
feeding
attractant
in
the
end
use
product
olive
fly
attract
and
kill
(A&
K)
target
device;
EPA
registration
pending.
Ammonium
bicarbonate
acts
as
a
feeding
attractant
to
the
olive
fruit
fly
(Bactrocera
oleae.)
The
end
use
product
also
contains
the
active
ingredients
lambda
cyhalothrin
insecticide
and
the
pheromone
1,7
dioxaspiro(
5,5)
undecane
The
proposed
use
of
the
product
is
in
olive
orchards
to
control
the
olive
fruit
fly.
The
active
ingredient,
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Notices
ammonium
bicarbonate,
is
listed
by
the
U.
S.
Food
and
Drug
Administration
as
a
direct
food
additive
under
21
CFR
73.85,
163.110,
163.111,
163.112
and
is
listed
as
generally
recognized
as
safe
(GRAS)
under
21
CFR
184.1135.
It
is
exempt
from
the
requirement
of
a
tolerance
under
40
CFR
180.1001(
c)
when
used
as
an
inert
ingredient
in
pesticide
formulations
applied
to
growing
crops
or
to
raw
agricultural
commodities
after
harvest.
2.
The
ammonium
bicarbonate
in
the
end
use
product,
when
exposed
to
air,
decomposes
and
releases
gaseous
ammonia.
Ammonia
is
a
by
product
of
protein
decomposition
and
as
such
is
recognized
by
the
olive
fruit
fly
as
a
potential
food
source.
The
ammonia
released
from
the
end
use
product
attracts
the
insects
to
the
device.
Ammonia
per
se
is
exempt
from
the
requirement
of
a
tolerance
under
40
CFR
180.1003
when
used
as
a
fungicide
applied
to
grapefruit,
lemons,
oranges
and
corn
grain.
B.
Product
Identity/
Chemistry
1.
Identity
of
the
pesticide
and
corresponding
residues.
Ammonium
bicarbonate,
CAS
number
1066Ð
33Ð
7,
is
also
known
as
ammonium
hydrogen
carbonate.
It
is
a
naturally
occurring
mineral.
It
is
a
white,
crystalline
powder
soluble
in
water
but
non
soluble
in
alcohol
and
acetone.
It
decomposes
at
36
to
60
degrees
centigrade
to
ammonia,
carbon
dioxide
and
water
vapor.
It
has
many
applications
including
use
in
baking
powders,
fire
extinguishing
mixtures,
agricultural
fertilizers
and
is
used
as
a
surfactant,
suspending
agent
and
dispersing
agent
in
pesticide
formulations.
2.
Magnitude
of
residue
at
the
time
of
harvest
and
method
used
to
determine
the
residue.
The
end
use
product
contains
4
grams
of
ammonium
bicarbonate
bound
in
a
polymer.
The
polymer
is
attached
to
a
cellulose
card
material
which
is
approximately
19
centimeters
(cm)
by
20
cm
in
size.
The
card
is
suspended
from
olive
tree
limbs
at
a
rate
of
42
cards
per
acre
of
olive
orchard
resulting
in
168
grams
(0.37
pounds)
of
ammonium
bicarbonate
per
acre
of
orchard.
Being
contained
in
the
polymer
and
attached
to
the
cellulose
card
there
is
little
opportunity
for
the
ammonium
bicarbonate
to
come
in
contact
with
either
the
fruit
or
the
soil.
Upon
application
the
end
use
product
will
be
constantly
exposed
to
sunlight
and
elevated
temperatures
which
will
continually
release
very
small
amounts
of
gaseous
ammonia.
Ammonia
is
a
naturally
occurring
compound
which
is
a
key
intermediate
in
the
nitrogen
cycle.
Under
normal
conditions,
ammonia
is
essential
for
many
biological
processes.
Ammonia
may
be
released
to
the
atmosphere
by
volatilization
from
numerous
sources
including:
Decaying
organic
matter,
animal
livestock
excreta,
fertilization
of
soil,
and
burning
of
coal,
wood,
and
other
natural
products.
Because
of
its
significance
in
natural
cycles,
ammonia
is
found
at
a
local
concentration
in
most
environmental
media.
The
half
life
of
atmospheric
ammonia
is
estimated
to
be
only
a
few
days.
In
olive
orchards
atmospheric
concentrations
of
ammonia
will
be
present
from
the
decay
of
organic
matter
and
from
the
application
of
fertilizer
to
soil
as
ammonia,
ammonium
compounds
or
ammonia
precursors
(such
as
urea).
Because
ammonia,
as
ammonium
ion,
is
the
nutrient
of
choice
for
many
plants,
uptake
of
soil
ammonia
by
living
plants
is
an
important
fate
process.
The
rate
of
uptake
by
plants
varies
with
the
growing
season.
At
normal
environmental
concentrations,
ammonia
does
not
have
a
very
long
soil
half
life.
It
is
either
rapidly
taken
up
by
plants,
bioconverted
by
the
microbial
population,
or
volatilized
to
the
atmosphere.
Under
the
conditions
of
use
proposed
and
given
the
natural
background
levels
of
ammonia
in
the
atmosphere
and
in
the
soil,
no
residues
of
ammonia
or
of
ammonium
bicarbonate
are
expected
to
occur
in
olive
fruit
from
the
use
of
the
olive
fly
attract
and
kill
(A&
K)
target
device.
3.
Residues
in
olive
fruit
are
not
expected
from
the
use
of
the
olive
fly
attract
and
kill
target
device;
therefore,
an
analytical
method
is
not
needed.
C.
Mammalian
Toxicological
Profile
Because
toxicity
studies
in
the
scientific
literature
are
limited
for
ammonium
bicarbonate,
data
on
the
related
ammonium
salt,
ammonium
chloride,
and
on
the
carbonate
salt,
sodium
bicarbonate,
are
discussed.
The
single
dose
LD50
of
ammonium
chloride
in
the
mouse
and
the
rat,
administered
orally,
is
reported
in
scientific
literature
as
1,300
milligrams/
kilogram
(mg/
kg)
and
1,650
mg/
kg,
respectively.
The
single
dose
LD50
of
sodium
bicarbonate
in
the
mouse
and
rat,
administered
orally,
is
reported
in
scientific
literature
as
5,650
mg/
kg
and
3,400
mg/
kg,
respectively.
For
ammonia,
the
acute
inhalation
LC50
in
the
rat
exposed
for
a
single
period
of
15
minutes,
was
reported
in
scientific
literature
as
17,401
parts
per
million
(ppm).
The
acute
inhalation
LC50
in
the
mouse
exposed
for
a
single
period
of
30
minutes
was
reported
as
21,430
ppm.
D.
Aggregate
Exposure
1.
Dietary
exposureÑ
i.
Food.
Ammonium
bicarbonate
as
used
in
the
olive
fly
attract
and
kill
target
device
will
not
come
into
direct
contact
with
olives.
Therefore,
no
residues
of
this
compound
are
expected
to
occur
in
olives.
Ammonium
bicarbonate
is
listed
by
the
U.
S.
Food
and
Drug
Administration
as
a
direct
food
additive
and
is
commonly
used
as
a
leavening
agent
in
baked
goods.
There
is
some
potential
for
the
decomposition
product
ammonia
gas
to
come
into
contact
with
growing
olives.
However,
it
is
expected
that
levels
of
gaseous
ammonia
would
be
well
below
the
normal
background
levels
of
atmospheric
ammonia
present
in
an
area
of
crop
production.
ii.
Drinking
water.
Given
the
mode
of
application
whereby
the
ammonium
bicarbonate
is
bound
in
a
polymer
matrix
attached
to
a
cellulose
card
which
is
suspended
from
olive
tree
branches,
there
is
little
likelihood
that
residues
of
ammonium
bicarbonate
would
occur
in
drinking
water
from
this
use.
2.
Non
dietary
exposure.
When
exposed
to
air,
sun
and
elevated
temperatures
in
an
olive
orchard,
the
ammonium
bicarbonate
will
slowly
decompose
to
ammonia,
carbon
dioxide,
and
water
vapor.
The
total
amount
of
ammonium
bicarbonate
applied
per
acre
in
the
olive
fly
attract
and
kill
target
devices
is
168
grams.
Assuming
the
complete
consumption
of
the
ammonium
bicarbonate
during
the
growing
season,
the
theoretical
yield
of
ammonia
would
be
equal
to
approximately
36.1
grams.
Assuming
that
this
amount
of
ammonia
is
distributed
over
an
acre
of
olive
orchard
to
a
height
of
15
feet
at
a
single
point
in
time,
this
is
equal
to
a
theoretical
concentration
of
3
parts
per
billion
(ppb)
of
ammonia.
But
a
more
realistic
scenario
would
take
into
account
that
the
release
of
ammonia
would
occur
over
the
4Ð
5
month
period
after
application
in
the
orchard
resulting
in
a
daily
concentration
that
is
approximately
one
hundred
times
less,
i.
e.
0.025
ppb.
This
concentration
of
ammonia
would
be
well
below
the
worldwide
atmospheric
background
concentration
of
ammonia
that
has
been
estimated
in
scientific
literature
at
approximately
1Ð
3
ppb.
Also
by
comparison,
farmers
can
be
exposed
to
ammonia
when
applying
fertilizer.
The
ammonia
concentration
over
a
field
during
the
application
of
gaseous
anhydrous
ammonia
fertilizer
was
reported
in
scientific
literature
as
high
as
213
microgram/
cubic
meter
(ug/
m
3
)
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300
ppb.
This
is
ten
thousand
fold
higher
than
the
theoretical
exposure
from
the
olive
fly
attract
and
kill
target
device.
E.
Cumulative
Exposure
Because
of
the
method
of
application
and
the
low
use
rates
of
ammonium
bicarbonate,
little
to
no
exposure
is
expected.
Since
ammonium
bicarbonate
is
approved
as
a
direct
food
additive
and
is
listed
as
``
Generally
Recognized
as
Safe''
by
the
U.
S.
Food
and
Drug
Administration,
there
is
no
concern
regarding
the
potential
for
cumulative
effects
of
ammonium
bicarbonate
from
the
proposed
use
with
other
substances
due
to
a
common
mechanism
of
action.
F.
Safety
Determination
1.
U.
S.
population.
Evidence
of
ammonium
bicarbonate's
low
toxicity
is
demonstrated
in
the
data
reported
for
the
related
salts,
ammonium
chloride
and
sodium
bicarbonate.
The
U.
S.
Food
and
Drug
Administration
has
placed
the
following
limitations
on
the
maximum
allowable
levels
of
ammonium
bicarbonate
in
processed
foods:
up
to
3.2%
in
baked
goods,
grain,
snack
foods
and
reconstituted
vegetables.
This
is
the
equivalent
of
32,000
ppm
of
ammonium
bicarbonate
concentration
in
these
foods.
Ammonium
bicarbonate
is
exempt
from
the
requirement
of
a
tolerance
under
40
CFR
180.1001(
c)
when
it
is
used
as
a
surfactant,
suspending
agent
or
dispensing
agent
in
pesticide
formulations
applied
to
growing
crops
or
to
raw
agricultural
commodities
after
harvest.
The
amount
of
ammonium
bicarbonate
used
in
a
pesticide
formulation
is
not
restricted
by
40
CFR
180.1001(
c).
Therefore,
any
level
of
residue
of
ammonium
bicarbonate
in
or
on
olives
is
currently
acceptable
when
used
for
these
purposes.
Given
the
method
of
application
of
ammonium
bicarbonate
where
it
is
bound
in
a
polymer
within
a
discrete
target
device
it
is
extremely
unlikely
for
this
compound
to
come
into
contact
with
and
result
in
residues
in
or
on
olive
fruit.
Thus,
aggregate
exposure
to
ammonium
bicarbonate
from
use
in
the
olive
fly
attract
and
kill
target
device
and
any
risk
to
human
health
will
be
negligible.
2.
Infants
and
children.
Given
the
low
toxicity
of
the
related
salts
ammonium
chloride
and
sodium
bicarbonate
and
the
allowable
levels
of
ammonium
bicarbonate
in
processed
foods,
there
is
a
reasonable
certainty
of
no
harm
to
children
and
infants
from
the
use
of
the
olive
fly
attract
and
kill
target
device
in
olive
orchards.
G.
Effects
on
the
Immune
and
Endocrine
Systems
Certis
USA
has
no
information
to
suggest
that
ammonium
bicarbonate
will
adversely
affect
the
immune
or
endocrine
systems.
H.
Existing
Tolerances
Ammonium
bicarbonate
is
exempt
from
the
requirement
of
a
tolerance
under
40
CFR
180.1001(
c)
when
used
as
an
inert
ingredient
in
pesticide
formulations
applied
to
growing
crops
or
to
raw
agricultural
commodities
after
harvest.
Ammonia
is
exempt
from
the
requirement
of
a
tolerance
under
40
CFR
180.1003
when
used
as
a
fungicide
applied
to
grapefruit,
lemons,
oranges,
and
corn
grain.
I.
International
Tolerances
There
is
no
Codex
maximum
residue
level
(MRL)
for
ammonium
bicarbonate.
Canada
has
established
permitted
residue
levels
of
ammonium
bicarbonate
in
cocoa
products
and
in
unstandardized
food
products.
[FR
Doc.
02Ð
24343
Filed
9Ð
24Ð
02;
8:
45
am]
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that
are
available
electronically.
Once
in
the
system,
select
``
search,
''
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| epa | 2024-06-07T20:31:43.215135 | regulations | {
"license": "Public Domain",
"url": "https://downloads.regulations.gov/EPA-HQ-OPP-2002-0214-0001/content.txt"
} |
EPA-HQ-OPP-2002-0216-0001 | Rule | "2002-09-25T04:00:00" | Tolylfluanid; Pesticide Tolerance. | 60130
Federal
Register
/
Vol.
67,
No.
186
/
Wednesday,
September
25,
2002
/
Rules
and
Regulations
paragraphs
(a)(
1)
and
(a)(
2)
to
read
as
follows:
§
1955.3
General
policy.
(a)
*
*
*
(1)
Whenever
the
Assistant
Secretary
determines
that
under
§
1902.2(
b)
of
this
chapter
a
State
has
not
substantially
completed
the
developmental
steps
of
its
plan
at
the
end
of
three
years
from
the
date
of
commencement
of
operations,
a
withdrawal
proceeding
shall
be
instituted.
Examples
of
a
lack
of
substantial
completion
of
developmental
steps
include
but
are
not
limited
to
the
following:
*
*
*
*
*
(2)
Whenever
the
Assistant
Secretary
determines
that
there
is
no
longer
a
reasonable
expectation
that
a
State
plan
will
meet
the
criteria
of
§
1902.3
of
this
chapter
involving
the
completion
of
developmental
steps
within
the
three
year
period
immediately
following
commencement
of
operations,
a
withdrawal
proceeding
shall
be
instituted.
Examples
of
a
lack
of
reasonable
expectation
include
but
are
not
limited
to
the
following:
*
*
*
*
*
[FR
Doc.
02–
24284
Filed
9–
24–
02;
8:
45
am]
BILLING
CODE
4510–
26–
P
ENVIRONMENTAL
PROTECTION
AGENCY
40
CFR
Part
180
[OPP–
2002–
0216;
FRL–
7200–
5]
Tolylfluanid;
Pesticide
Tolerance
AGENCY:
Environmental
Protection
Agency
(EPA).
ACTION:
Final
rule.
SUMMARY:
This
regulation
establishes
an
import
tolerance
for
residues
of
tolylfluanid
in
or
on
imported
apple,
grape,
hop,
and
tomato.
Bayer
Corporation
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
September
25,
2002.
Objections
and
requests
for
hearings,
identified
by
docket
ID
number
OPP–
2002–
0216,
must
be
received
on
or
before
November
25,
2002.
ADDRESSES:
Written
objections
and
hearing
requests
may
be
submitted
by
mail,
in
person,
or
by
courier.
Please
follow
the
detailed
instructions
for
each
method
as
provided
in
Unit
VI.
of
the
SUPPLEMENTARY
INFORMATION.
To
ensure
proper
receipt
by
EPA,
your
objections
and
hearing
requests
must
identify
docket
ID
number
OPP–
2002–
0216
in
the
subject
line
on
the
first
page
of
your
response.
FOR
FURTHER
INFORMATION
CONTACT:
By
mail:
Mary
Waller,
Registration
Division
(7505C),
Office
of
Pesticide
Programs,
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460–
0001;
telephone
number:
(703)
308–
9354;
e
mail
address:
waller.
mary@
epa.
gov.
SUPPLEMENTARY
INFORMATION:
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:
Categories
NAICS
codes
Examples
of
potentially
affected
entities
Industry
111
112
311
32532
Crop
production
Animal
production
Food
manufacturing
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
the
table
could
also
be
affected.
The
North
American
Industrial
Classification
System
(NAICS)
codes
have
been
provided
to
assist
you
and
others
in
determining
whether
or
not
this
action
might
apply
to
certain
entities.
If
you
have
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
Additional
Information,
Including
Copies
of
this
Document
and
Other
Related
Documents?
1.
Electronically.
You
may
obtain
electronic
copies
of
this
document,
and
certain
other
related
documents
that
might
be
available
electronically,
from
the
EPA
Internet
home
page
at
http://
www.
epa.
gov/.
To
access
this
document,
on
the
home
page
select
``
Laws
and
Regulations,
''
``
Regulations
and
Proposed
Rules,
''
and
then
look
up
the
entry
for
this
document
under
the
``
Federal
Register—
Environmental
Documents.
''
You
can
also
go
directly
to
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.
2.
In
person.
The
Agency
has
established
an
official
record
for
this
action
under
docket
ID
number
OPP–
2002–
0216.
The
official
record
consists
of
the
documents
specifically
referenced
in
this
action,
and
other
information
related
to
this
action,
including
any
information
claimed
as
Confidential
Business
Information
(CBI).
This
official
record
includes
the
documents
that
are
physically
located
in
the
docket,
as
well
as
the
documents
that
are
referenced
in
those
documents.
The
public
version
of
the
official
record
does
not
include
any
information
claimed
as
CBI.
The
public
version
of
the
official
record,
which
includes
printed,
paper
versions
of
any
electronic
comments
submitted
during
an
applicable
comment
period
is
available
for
inspection
in
the
Public
Information
and
Records
Integrity
Branch
(PIRIB),
Rm.
119,
Crystal
Mall
#2,
1921
Jefferson
Davis
Hwy.,
Arlington,
VA,
from
8:
30
a.
m.
to
4
p.
m.,
Monday
through
Friday,
excluding
legal
holidays.
The
PIRIB
telephone
number
is
(703)
305–
5805.
II.
Background
and
Statutory
Findings
In
the
Federal
Register
of
August
11,
1997
(62
FR
42980)
(FRL–
5736–
1),
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
7E4825)
by
Bayer
Corporation,
8400
Hawthorn
Rd.,
Kansas
City,
MO
64120.
This
notice
included
a
summary
of
the
petition
prepared
by
Bayer
Corporation,
the
registrant.
There
were
no
comments
received
in
response
to
the
notice
of
filing.
The
petition
requested
that
40
CFR
180.584
be
amended
by
establishing
an
import
tolerance
for
residues
of
the
fungicide
tolylfluanid,
(1,1
dichloro
N
dimethylamino)
sulfonyl]
1
fluoro
N
4
methylphenyl)
methanesulfenamide),
in
or
on
apple
at
5.0
parts
per
million
(ppm),
grape
at
5.0
ppm,
hop
at
30
ppm,
and
tomato
at
1.0
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
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/
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No.
186
/
Wednesday,
September
25,
2002
/
Rules
and
Regulations
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
tolylfluanid
in
or
on
apple
at
5.0
ppm,
grape
at
11
ppm,
hop
at
30
ppm,
and
tomato
at
2.0
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
tolylfluanid
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
=
20.1
milligram/
kilogram/
day
(mg/
kg/
day)
male
(M)
LOAEL
=
108
mg/
kg/
day,
based
on
changes
in
clinical
blood
chemistry
associated
with
the
liver
and
thyroid
(M)
NOAEL
=
131
mg/
kg/
day
female
(F)
LOAEL
=
736.1
mg/
kg/
day,
based
on
changes
in
clinical
blood
chemistry
associated
with
the
liver
and
thyroid
and
decreased
body
weights
(F)
Acceptable/
guideline
870.3150
90
Day
oral
toxicity
in
nonrodents
(dog)
NOAEL
=
23.1/
25
mg/
kg/
day
(F/
M)
LOAEL
=
67.2/
69.4
(F/
M)
mg/
kg/
day,
based
on
decreased
body
weight
gains
and
changes
in
liver
structure
and
function
in
both
sexes
Unacceptable/
guideline
870.3700
Prenatal
developmental
in
rodents
(rat)
Maternal
NOAEL
=
not
determined
LOAEL
=
100
mg/
kg/
day,
based
on
decreased
body
weight
gains
and
food
consumption.
Developmental
NOAEL
=
1,000
mg/
kg/
day
highest
dose
tested
(HDT)
LOAEL
>
1,000
mg/
kg/
day
Acceptable/
guideline
870.3700
Prenatal
developmental
in
rodents
(rat)
Maternal
NOAEL
=
100
mg/
kg/
day
LOAEL
=
300
mg/
kg/
day,
based
on
dose
related
decreased
body
weight
gains
during
the
dosing
interval.
Developmental
NOAEL
>
1,000
mg/
kg/
day
(HDT)
LOAEL
=
not
identified
Acceptable/
guideline
870.3700
Prenatal
developmental
in
nonrodents
(rabbit)
Maternal
NOAEL
=
25
mg/
kg/
day
LOAEL
=
70
mg/
kg/
day,
based
on
evidence
of
hepatotoxicity
increased
glutamate
dehydrogenase
(GLDH)
and
triglyceride
levels
and
gross
and
microscopic
liver
pathology)
and
decreased
food
consumption
and
equivocal
decreases
in
body
weight
gain.
Developmental
NOAEL
=
25
mg/
kg/
day
LOAEL=
70
mg/
kg/
day,
based
on
increased
malformations
(arthrogryposis
of
front
extremities
and
small
orbital
cavity/
folded
retina)
and
variations
(floating
rib
and
accelerated
ossification).
Acceptable/
guideline
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186
/
Wednesday,
September
25,
2002
/
Rules
and
Regulations
TABLE
1.—
SUBCHRONIC,
CHRONIC,
AND
OTHER
TOXICITY—
Continued
Guideline
No.
Study
Type
Results
870.3800
2
Generation
reproduction
and
fertility
effects
(rat)
Parental/
systemic
NOAEL
=
7.9–
10.5
mg/
kg/
day
LOAEL
=
57.5–
78.0
mg/
kg/
day,
based
on
decreased
body
weights,
body
weight
gains,
and
liver
weights
in
the
P
females
Reproductive
NOAEL
=
7.9–
10.5
mg/
kg/
day
LOAEL
=
57.5–
78.0
mg/
kg/
day,
based
on
reduced
litter
size
Offspring
NOAEL
=
7.9–
10.5
mg/
kg/
day
LOAEL
=
57.5–
78.0
mg/
kg/
day,
based
on
decreased
pup
weights,
increased
pup
deaths
and
related
pup
viability
indices
Acceptable/
guideline
870.3800
2
Generation
reproduction
and
fertility
effects
(rat)
Parental/
systemic
NOAEL
not
established
LOAEL
=
15.9–
21.5
mg/
kg/
day,
based
on
hardened
crania
of
P
generation
animals
Reproductive
NOAEL
not
established
LOAEL
=
15.9–
21.5
mg/
kg/
day,
based
on
increased
clinical
signs
of
toxicity
Offspring
NOAEL
>
15.9–
21.5
mg/
kg/
day
(HDT)
LOAEL
not
established
Unacceptable/
guideline
870.3800
2
Generation
reproduction
and
fertility
effects
(rat)
Parental/
Systemic
NOAEL
=
20.1–
26.3
mg/
kg/
day
LOAEL
=
83.4–
109.5
mg/
kg/
day,
based
on
decreased
body
weights
and
body
weight
gains
Reproductive
NOAEL
=
83.4
109.5
mg/
kg/
day
LOAEL
=
335.6–
492.4
mg/
kg/
day,
based
on
decreased
mean
litter
size
Offspring
NOAEL
=
20.1–
26.3
mg/
kg/
day
LOAEL
=
83.4–
109.5
mg/
kg/
day,
based
on
decreased
pup
weights
Acceptable/
guideline
870.3800
2
Generation
reproduction
and
fertility
effects
(rat)
Parental/
Systemic
NOAEL
=
75
mg/
kg/
day
LOAEL
=
375
mg/
kg/
day,
based
on
decreased
body
weights
and
body
weight
gains
for
both
generations
Reproductive
NOAEL
>
375
mg/
kg/
day
(HDT)
LOAEL
not
established
Offspring
NOAEL
=
75
mg/
kg/
day
LOAEL
=
375
mg/
kg/
day,
based
on
decreased
survival
and
reduced
body
weights
during
lactation
Acceptable/
guideline
870.4300
Combined
chronic
toxicity/
carcinogenicity
rodents
(rat)
NOAEL
=
18.1/
21.1
mg/
kg/
day
(M/
F)
LOAEL
=
90.1/
105.2
mg/
kg/
day
(M/
F),
based
on
skeletal
changes
Evidence
of
thyroid
follicular
cell
adenomas
and/
or
carcinomas
in
high
dose
males
and
females
Acceptable/
guideline
870.4300
Combined
chronic
toxicity/
carcinogenicity
rodents
(rat)
NOAEL
=
20/
20
mg/
kg/
day
(M/
F)
LOAEL
=
80/
110
mg/
kg/
day
(M/
F),
based
on
bone
hyperostosis
in
males
and
females
Evidence
of
thyroid
follicular
cell
adenomas
and/
or
carcinomas
in
high
dose
males
and
females
Acceptable/
guideline
870.4200
Carcinogenicity
rodents
(mouse)
NOAEL
=
76.3/
123.9
mg/
kg/
day
(M/
F)
LOAEL
=
375.8/
610.8
mg/
kg/
day
(M/
F),
based
on
skeletal,
liver,
and
kidney
changes
No
evidence
of
carcinogenicity
Acceptable/
guideline
870.4100
Chronic
toxicity
(dog)
NOAEL
=
12.5
mg/
kg/
day
LOAEL
=
62.5
mg/
kg/
day
(M),
based
on
decreased
body
weight
gains
Acceptable/
guideline
870.5100
Technical
Bacterial
gene
mutation
assay
Tolylfluanid
was
cytotoxic
to
all
strains
at
8
µ
g/
plate
±
S9
and
precipitated
from
solutions
in
all
strains
at
5,000
µ
g/
plate
±
S9.
There
were
no
reproducible,
dose
related
differences
in
the
number
of
revertant
colonies
in
any
strain
or
dose
over
the
background
Positive
controls
induced
appropriate
response.
Acceptable/
guideline
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25,
2002
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Rules
and
Regulations
TABLE
1.—
SUBCHRONIC,
CHRONIC,
AND
OTHER
TOXICITY—
Continued
Guideline
No.
Study
Type
Results
870.5100
Metabolite—
WAK
5815
Bacterial
gene
mutation
assay
There
was
no
evidence
of
toxicity
or
significant
increase
in
mutant
colonies
over
background
in
any
of
strains
tested
in
either
the
initial
or
repeat
mutagenicity
assays.
Positive
controls
induced
appropriate
response.
Acceptable/
guideline
870.5100
Metabolite—
WAK
6550
Bacterial
gene
mutation
assay
There
were
no
reproducible,
dose
related
differences
in
the
number
of
revertant
colonies
in
any
strain
or
dose
over
the
background
Positive
controls
induced
appropriate
response.
Acceptable/
guideline
870.5100
Metabolite—
WAK
6676
Bacterial
gene
mutation
assay
There
was
no
evidence
of
toxicity
or
significant
increase
in
the
mutant
colonies
over
background
in
any
strain
tested.
Positive
controls
induced
the
appropriate
responses
in
the
corresponding
strains
and
in
the
solvent
controls
were
consistent
with
the
expected
ranges
of
revertant
colonies
for
the
strains
used.
Acceptable/
guideline
870.5100
Metabolite—
WAK
6698
Bacterial
gene
mutation
assay
Metabolite
was
cytotoxic
at
doses
158
µ
g/
plate
in
the
initial
assay
and
1,581
µ
g/
plate
in
the
repeat
assay.
There
was
no
evidence
of
a
significant
increase
in
mutant
colonies
over
background
in
any
strains
tested
in
the
initial
or
repeat
mutagenicity
assays.
Positive
controls
induced
appropriate
response.
Acceptable/
guideline
870.5100
Technical
Bacterial
gene
mutation
assay
Tolylfluanid
was
tested
to
cytotoxic
concentrations.
Tolylfluanid
showed
no
evidence
of
inducing
methionine
revertants
in
Saccharomyces
cerevisiae
strains
±
S9.
However,
one
of
the
tests
(S211
)
was
inadequate
or
inconsistent.
Further,
in
the
S9
activated
assays,
the
positive
controls
did
not
elicit
an
adequate
response
negating
the
test
with
S9
for
both
strains.
Unacceptable/
guideline
870.5300
Metabolite—
WAK
6698
In
vitro
mammalian
cell
gene
mutation
assay
The
compound
was
tested
up
to
cytotoxic
concentrations
in
two
independent
assays
(
S9).
In
the
initial
test
concentrations
ranged
from
50
to
1,000
µ
g/
mL
±
S9.
In
the
repeat
assay
concentrations
ranged
from
100
to
800
µ
g/
mL
S9
and
200
to
700
µ
g/
mL
+
S9.
Tolylfluanid
metabolite
was
negative
for
inducing
forward
mutations
at
the
TK
locus
in
mouse
L5178Y
±
S9.
Positive
control
methyl
methanosulfonate
and
3
methylcholanthrene
induced
appropriate
responses.
Acceptable/
guideline
870.5300
Technical
In
vitro
mammalian
cell
gene
mutation
assay
These
dose
levels
were
selected
based
on
a
preliminary
cytotoxicity
study
conducted
at
0.5
to
250
µ
g/
mL
±
S9.
Tolylfluanid
has
been
judged
to
be
non
mutagenic
±
S9.
Positive
controls
induced
appropriate
response
±
S9.
Acceptable/
guideline
870.5300
Technical
In
vitro
mammalian
cell
gene
mutation
assay
Cultures
were
tested
to
cytotoxic
concentrations.
Tolylfluanid
has
been
judged
to
be
non
mutagenic
±
S9.
Positive
controls
induced
appropriate
response
±
S9.
Acceptable/
guideline
870.5300
Technical
In
vitro
mammalian
cell
gene
mutation
assay
The
compound
was
tested
up
to
cytotoxic
concentrations
(
S9).
Tolylfluanid
was
positive
for
inducing
forward
mutations
at
the
TK
locus
in
mouse
L5178Y
±
S9.
Positive
control
ethylmethane
sulfonate
and
3
methylcholanthrene
induced
appropriate
responses
Colony
sizing
was
not
performed.
Acceptable/
guideline
Non
Guideline
Technical
Mouse
spot
test
F1
pups
from
female
C57B1/
6J
mice
exposed
by
oral
gavage
to
tolylfluanid
(98.4%)
at
concentration
of
0;
1,750;
3,500;
and
7,000
mg/
kg
did
not
show
difference
in
incidence
in
relative
spots
between
the
treated
and
controls.
Systemic
toxicity
was
observed
in
dams
at
all
doses.
Mortality
was
observed
at
all
doses;
however
treatment
did
not
affect
reproductive
parameters
nor
there
was
difference
in
litter
size.
Positive
controls
showed
a
clear
increase
in
spots
in
the
progeny.
Acceptable/
non
guideline
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186
/
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25,
2002
/
Rules
and
Regulations
TABLE
1.—
SUBCHRONIC,
CHRONIC,
AND
OTHER
TOXICITY—
Continued
Guideline
No.
Study
Type
Results
870.5375
Technical
In
vitro
mammalian
cell
gene
mutation
assay
The
test
was
conducted
up
to
cytotoxic
levels
±
S9.
Tolylfluanid
was
weakly
clastogenic
in
Chinese
hamster
V79
cells
in
the
presence
of
S9
activation.
Positive
control
mitomycin
and
cyclophosphamide
induced
appropriate
responses.
Acceptable/
guideline
870.5375
Technical
In
vitro
mammalian
cell
gene
mutation
assay
Cytotoxicity
was
observed
at
concentrations
1
to
10
µ
g/
milliliter
(mL)
S9
and
5
to
10
µ
g/
mL
+S9.
Over
the
ranges
tested
clastogenic
effects
included
increased
incidences
of
metaphases
with
aberrations
including
gaps,
metaphases
excluding
gaps,
metaphases
with
exchanges,
and
metaphases
with
polyploidy
were
observed.
Tolyfluanid
is
clastogenic
both
in
the
presence
and
in
the
absence
of
S9
activation.
Positive
control
mitomycin
and
endoxan
induced
appropriate
responses.
Acceptable/
guideline
870.5380
Technical
In
vitro
mammalian
spermatogonia
chromosomal
aberration
test
No
mortality
or
clinical
signs
were
observed
at
either
dose.
No
statistically
significant
increases
in
the
frequency
of
chromosomal
aberrations
in
spermatogonia
were
observed.
Unacceptable/
guideline
870.5380
Technical
In
vitro
mammalian
spermatogonia
chromosomal
aberration
test
Clinical
signs
of
toxicity
and
cytotoxicity
to
target
cells
were
seen
at
5,000
mg/
kg/
day.
Tolylfluanid
did
not
induce
chromosomal
aberrations
in
spermatogonia
at
any
dose.
Positive
controls
did
not
produce
strong
positive
results.
Therefore,
sensitivity
of
assay
is
questionable
and
the
findings
of
the
study
are
equivocal.
Unacceptable/
guideline
870.5385
Technical
Mammalian
bone
marrow
chromosomal
aberration
test
3/
10
animals
died
but
exhibited
no
clinical
signs.
No
cytotoxicity
was
observed
at
the
dose
tested.
Positive
controls
induced
appropriate
response.
Inadequate
sampling
time
and
no
indication
of
test
material
present
at
target
site;
therefore,
data
not
valid
for
regulatory
purposes.
Unacceptable/
guideline
870.5385
Technical
Mammalian
bone
marrow
chromosomal
aberration
test
3/
10
of
10
animals
died
but
no
clinical
signs
of
toxicity
were
observed
at
the
dose
tested.
Test
results
were
erratic.
Positive
controls
induced
appropriate
response.
Inadequate
study
since
test
samples
were
not
analyzed
and
doses
were
not
high
enough
to
produce
toxicity.
Unacceptable/
guideline
870.5395
Technical
Mammalian
erythrocyte
micronucleus
assay
No
clinical
signs
of
toxicity
was
observed
and
was
not
toxic
to
the
target
tissue.
Treatment
with
tolylfluanid
did
not
induce
micronucleated
polychromatic
erythrocytes.
Inadequate
methods
and
methodology.
Unacceptable/
guideline
870.5450
Technical
Dominant
lethal
assay
(mice)
Did
not
induce
variations
in
any
dominant
lethal
parameters
nor
any
reduced
fertility.
Inadequate
study.
No
positive
control
data
Unacceptable
but
upgradable
with
receipt
of
positive
control
data
870.5915
Technical
In
vivo
sister
chromatid
exchange
assay
Mortality
at
500
mg/
kg
and
above.
Tolylfluanid
did
not
induce
sister
chromatid
exchange
at
any
dose
level.
Positive
control
cyclophosphamide
responded
appropriately.
Acceptable/
guideline
870.5500
Technical
Other
genotoxic
effects
unscheduled
DNA
synthesis
(UDS)
in
mammalian
cells
Tolylfluanid
did
not
induce
UDS
up
to
15.0
µ
g/
mL.
The
17.5
and
20
µ
g/
mL
doses
were
highly
toxic.
The
positive
control
2
acetylaminofluorene
responded
appropriately.
Acceptable/
guideline
870.6200
Acute
neurotoxicity
screening
battery
(rat)
NOAEL
=
50
mg/
kg
in
females
LOAEL
=
150
mg/
kg/
day
based
on
functional
observation
battery
(FOB)
effects
and
decreased
motor
and
locomotor
activity
in
females
NOAEL
=
2,000
mg/
kg/
day
(M)—
limit
dose
LOAEL
=
not
established
(M)
Acceptable/
guideline
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/
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25,
2002
/
Rules
and
Regulations
TABLE
1.—
SUBCHRONIC,
CHRONIC,
AND
OTHER
TOXICITY—
Continued
Guideline
No.
Study
Type
Results
870.6200
Subchronic
neurotoxicity
screening
battery
(rat)
NOAEL
=
25
mg/
kg
(F)
LOAEL
=
134
mg/
kg
based
on
decreased
mean
body
weights
in
females.
No
treatment
related
neurotoxicological
effects
were
observed
at
any
treatment
level.
Acceptable/
guideline
870.7485
Metabolism
and
pharmacokinetics
(rat)
In
a
metabolism
study
in
rats,
tolylfluanid
was
administered
in
single
doses
of
2
or
100
mg/
kg
of
body
weight,
was
readily
absorbed
and
rapidly
hydrolyzed
within
48
hours.
Absorption
and
excretion
were
independent
of
dose,
sex,
and
pretreatment.
About
86–
100%
of
the
dose
was
recovered
in
48
hours,
with
56–
80%
of
the
dose
being
excreted
in
urine,
12–
36%
in
the
feces,
and
0.48%
found
in
the
carcass.
Urinary
metabolite
common
to
both
sexes
were
dimethylaminosulfonylamino
benzoic
acid
(RNH
0166;
46–
78%),
and
4
methylamino
benzoic
acid
(RNH
0416;
3–
6%).
Fecal
compounds
identified
were
unchanged
tolylfluanid
(1–
19%),
dimethylaminosulfotoluidid
(DMST;
5–
8%),
RNH
0166
(3–
12%),
and
RNH
0416
(
1%).
The
data
indicate
that
tolylfluanid
hydrolyzed
to
DMST,
which
is
then
transformed
to
the
major
metabolite
RNH
0166,
which
can
be
further
demethylated
to
the
minor
metabolite,
RNH
0416
(MRID
No.
44285805).
Acceptable/
guideline
870.7485
Metabolism
and
pharmacokinetics
(rat)
Series
of
metabolism
studies
showed
that
metabolic
profile
dependent
upon
label
position.
With
[dichlorofluoromethyl
14
C]
tolylfluanid
labeling
major
urinary
metabolite
was
thiazolidine
2
thione
4carbonic
acid
resulting
from
cleavage
of
the
side
chain
and
accounted
for
73–
74%
and
50–
63%,
respectively
by
IV
and
oral
routes.
Benzene
ring
label
resulted
in
metabolite
4
(dimethylamino
sulfonylamino)
benzoic
acid
which
accounted
for
90%
of
urinary
metabolic
activity
and
70%
of
fecal
radioactivity.
The
study
with
single
oral
dose
of
2
or
20
mg/
kg/
day
also
supported
the
results
of
the
main
study
(MRID
No.
44285805).
Non
guideline
Non
guideline
(rat)
thyroid
function
Thyroid
stimulating
hormone
levels
significantly
increased
(168–
425%)
in
high
dose
males
and
females.
Slightly
increased
T3
levels
in
males
rats
above
119.3
mg/
kg/
day
Acceptable/
nonguideline
Metabolite
Non
guideline
(mice)
In
vitro
investigation
of
TTCA
goitrogenic
properties
Tolylfluanid's
metabolite
TTCA
was
shown
to
reversibly
inhibit
thyroid
peroxidase
(TPO)
mediated
reactions
involved
with
the
initial
stages
of
thyroid
hormone
synthesis.
This
was
shown
by
the
dose
dependent
decrease
in
formation
of
reactive
iodine;
the
interference
of
the
nonenzymatic
and
TPO
mediated
iodination
of
L
tyrosine,
and
by
TPO
mediated
metabolism
of
TTCA.
In
the
latter
reaction,
TTCA
did
not
interfere
with
tyrosine
iodination
when
the
concentration
in
the
reaction
mixture
fell
below
a
certain
concentration.
Therefore,
TTCA,
unlike
tolylfluanid,
behaves
as
a
goitrogenic
compound
with
a
potency
approximately
equal
to
propylthiouracil
(PTU),
a
known
thionamide
inhibitor
of
initial
thyroid
hormone
synthesis.
Acceptable/
nonguideline
Non
guideline
Non
guideline
(rat)
32
P—
post
labelling
assay
In
a
32
P—
post
labelling
assay
for
detection
of
adduct
formation
in
lung,
thyroid,
and
liver
DNA
in
rats
revealed
that
there
was
no
evidence
of
DNA
adduct
formation
in
the
liver,
lung,
or
thyroid
of
rats
exposed
to
tolylfluanid.
Positive
control
2
acetylaminofluorene
(2
AAF)
(liver,
lung,
and
thyroid
DNA
adducts),
benzidine
(lung
DNA
adducts),
2
Thiourea
(lung
and
thyroid
DNA
adducts),
and
dibenz[
a,
h]
anthracene
(DBA)
(DNA
adducts
in
the
lungs)
produced
appropriate
results.
Acceptable/
nonguideline
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
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2002
/
Rules
and
Regulations
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.
In
this
case
because
it
is
an
import
tolerance
only,
there
is
only
dietary
risk.
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
tolylfluanid
used
for
human
risk
assessment
is
shown
in
Table
2
of
this
unit:
TABLE
2.—
SUMMARY
OF
TOXICOLOGICAL
DOSE
AND
ENDPOINTS
FOR
TOLYLFLUANID
FOR
USE
IN
HUMAN
RISK
ASSESSMENT
Exposure
Scenario
Dose
Used
in
Risk
Assessment,
UF
FQPA
SF*
and
Level
of
Concern
for
Risk
Assessment
Study
and
Toxicological
Effects
Acute
dietary
females
13–
50
years
of
age
NOAEL
=
25
UF
1
=
300
Acute
RfD
=
aPAD
=
0.083
mg/
kg/
day
1x
Prenatal
developmental
toxicity/
rabbit
LOAEL
=
70
mg/
kg/
day
based
on
increased
malformations
(arthrogryposis
of
front
extremities
and
small
orbital
cavity/
folded
retina)
and
variations
(floating
ribs
and
accelerated
ossification).
Acute
dietary
general
population
including
infants
and
children
NOAEL
=
50
UF
1
=
300
Acute
RfD
=
aPAD
=
0.17
mg/
kg/
day
1x
Acute
oral
neurotoxicity/
rat
LOAEL
=
150
mg/
kg/
day
based
on
FOB
effects
(pilorection,
decreased
activity,
gait
abnormalities,
decreased
body
temperature,
and/
or
decreased
rearing).
Chronic
dietary
all
populations
NOAEL=
7.9
UF
1
=
300
Chronic
RfD
=
cPAD
=
0.026
mg/
kg/
day
1x
2
Generation
reproduction/
rat
LOAEL
=
57.5
mg/
kg/
day
based
on
decreased
body
weights,
body
weight
gains,
and
liver
weights.
Cancer
Classification:
``
Likely
to
be
carcinogenic
to
humans''
by
the
oral
route,
based
on
thyroid
tumors
in
high
dose
male
and
female
rats.
The
FQPA
SF
Committee
further
recommended
a
linear
low
dose
extrapolation
approach
for
the
quantification
of
human
cancer
risk
based
on
the
thyroid
tumors
in
rats.
Q1*
=
1.59
x
10
3
based
upon
male
rat
thyroid
adenomas
and/
or
carcinomas
combined.
1
UF
(uncertainty
factor),
FQPA
Safety
Factor
(SF),
no
observed
adverse
effect
level
(NOAEL),
lowest
observed
adverse
effect
level
(LOAEL),
acute
Population
Adjusted
Dose
(aPAD),
chronic
Population
Adjusted
Dose
(cPAD),
reference
dose
(RfD).
*
The
reference
to
the
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.
This
activity
reflects
the
establishment
of
the
first
U.
S.
import
tolerance
for
tolylfluanid
on
apple,
grape,
hop,
and
tomato
without
a
U.
S.
registration.
Since
there
are
no
other
food
or
feed
uses
in
the
United
States,
the
only
exposure
to
occur
is
dietary.
Risk
assessments
were
conducted
by
EPA
to
assess
dietary
exposures
from
tolylfluanid
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
TM
7.76)
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
acute
Tier
2
(partially
refined
analysis)
exposure
assessments:
An
aPAD
of
0.083
mg/
kg/
day
was
used
for
females
between
13
and
50
years
of
age
based
on
developmental
toxicity
in
rabbits.
An
aPAD
of
0.17
was
used
for
the
general
U.
S.
population
(including
infants
and
children)
based
on
acute
neurotoxicity
in
rats.
Anticipated
residues
were
calculated
based
upon
submitted
field
trial
and
livestock
metabolism
data
for
all
proposed
uses
of
tolylfluanid.
The
resulting
acute
dietary
exposure
estimates
do
not
exceed
EPA's
level
of
concern
(
100%
aPAD)
at
the
95
th
exposure
percentile
for
females
13–
50
years
old
(42%
aPAD),
the
general
U.
S.
population
(31%
of
the
aPAD)
and
all
other
population
subgroups.
The
most
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highly
exposed
population
subgroup
is
infants
(
1
year
old,
at
100%
of
the
aPAD).
TABLE
3.—
ACUTE
DIETARY
EXPOSURE
TO
TOLYLFLUANID
Population
Subgroup
Acute
Dietary
1
Dietary
Exposure
(mg/
kg/
day)
%
aPAD
U.
S.
Population
(total)
0.051973
31
All
Infants
(
1
year
old)
0.169772
100
Children
1–
6
years
old
0.159553
94
Children
7–
12
years
old
0.063237
37
Females
13–
50
years
old
0.034529
20
Males
13–
19
years
old
0.023476
14
Males
20+
years
old
0.030744
18
Seniors
55+
years
old
0.033375
20
1
Acute
dietary
endpoint
of
0.083
mg/
kg/
day
applies
to
females
13–
50
years
old
only;
acute
dietary
endpoint
of
0.17
mg/
kg/
day
applies
to
the
general
U.
S.
population
(including
infants
and
children).
The
assessment
of
acute
dietary
exposure
used
the
following
conservative
assumptions
likely
to
generate
upper
end
estimates
of
the
quantity
of
tolylfluanid
and
tolylfluanid
residues
ingested:
No
import
consumption
data
were
used
in
the
assessment
(i.
e.,
the
assessment
assumes
that
all
acute
dietary
exposure
from
the
proposed
commodities
is
from
imported
commodities).
100%
crop
treated
(CT)
was
assumed
for
these
imported
commodities:
All
imported
grape,
apple,
hop,
and
tomato
were
assumed
to
have
been
treated
with
tolylfluanid
and
to
have
tolylfluanid
residues
at
the
level
of
the
tolerance.
Inclusion
of
additional
data,
such
as
%CT/
import
consumption
data
and/
or
monitoring
data
(including
metabolites
of
concern),
could
be
made
in
order
to
refine
the
acute
dietary
exposure
assessment.
ii.
Chronic
exposure.
In
conducting
this
chronic
dietary
risk
assessment
the
DEEM
TM
analysis
evaluated
the
individual
food
consumption
as
reported
by
respondents
in
the
USDA
1989–
1992
nationwide
CSFII
and
accumulated
exposure
to
the
chemical
for
each
commodity.
The
following
assumptions
were
made
for
the
chronic
exposure
assessments:
A
cPAD
of
0.026
mg/
kg/
day
was
used
based
on
the
2
generation
rat
reproduction
study.
All
dietary
exposure
from
the
proposed
commodities
is
from
imported
commodities.
Import
share
data
generated
within
the
Agency
were
used
in
the
assessment
to
estimate
what
proportion
of
the
grape,
apple,
hop,
and
tomato
consumed
in
the
United
States
are
imported.
Modified
DEEM
TM
processing
factors
based
on
the
results
of
processing
studies
were
used
for
raisins
and
apple
and
grape
juice/
juice
concentrates.
Default
DEEM
TM
processing
factors
were
used
for
all
other
processed
commodities.
Anticipated
residues
calculations
were
used
based
upon
submitted
field
trial
and
livestock
metabolism
data.
TABLE
4.—
CHRONIC
EXPOSURE
TO
TOLYLFLUANID
Population
Subgroup
Chronic
Dietary
1
Dietary
Exposure
(mg/
kg/
day)
%
aPAD
U.
S.
Population
(total)
0.000780
3
All
Infants
(
1
year
old)
0.003397
13
Children
1–
6
years
old
0.003638
14
Children
7–
12
years
old
0.001029
4
Females
13–
50
years
old
0.000399
2
Males
13–
19
years
old
0.000342
1
Males
20+
years
old
0.000340
1
Seniors
55+
years
old
0.000333
1
1
Chronic
dietary
endpoint
of
0.026
mg/
kg/
day
applies
to
general
U.
S.
population
and
all
population
subgroups.
The
assessment
of
chronic
dietary
exposure
for
the
general
U.
S.
population
and
all
population
subgroups
(including
infants
and
children)
used
the
following
conservative
assumptions
to
generate
upper
end
estimates
of
the
quantity
of
tolylfluanid
and
tolylfluanid
residues
ingested:
100%
CT
was
assumed
for
these
imported
commodities:
All
imported
grape,
apple,
hop,
and
tomato
were
assumed
to
have
been
treated
with
tolylfluanid
and
to
have
tolylfluanid
residues
at
the
level
of
the
tolerance.
The
calculated
ARs
(parent
and
additional
metabolites
of
concern
not
in
tolerance
expression)
are
based
on
field
trial
data,
submitted
by
the
registrant
to
support
tolerances.
Field
trial
residue
data
are
generally
considered
by
the
Agency
as
an
upper
end
or
a
worst
case
scenario
of
possible
residues
and
are
more
suited
to
the
requirements
of
tolerance
setting,
because
it
requires
highest
rates
of
application
and
shortest
PHI,
than
to
the
requirements
of
dietary
exposure
assessment
(when
a
more
realistic
estimate
is
desired).
The
chronic
dietary
exposure
estimates
do
not
exceed
EPA's
level
of
concern
(
100%
cPAD)
for
the
general
U.
S.
population
(3%
cPAD)
and
all
population
subgroups.
The
most
highly
exposed
population
subgroup
is
children
1–
6
years
old
at
14%
of
the
cPAD.
iii.
Cancer.
A
partially
refined,
cancer
dietary
exposure
assessment
was
conducted
for
the
general
U.
S.
population
using
the
same
assumptions
as
were
used
in
the
chronic
risk
assessment
(listed
in
the
preceding
section).
Import
share
data
generated
within
the
Agency
were
used
in
the
assessment
to
estimate
what
proportion
of
the
grape,
apple,
hop,
and
tomato
consumed
in
the
United
States
are
imported.
Modified
DEEM
TM
processing
factors
based
on
the
results
of
processing
studies
were
used
for
raisins
and
apple
and
grape
juice/
juice
concentrates.
Default
DEEM
TM
processing
factors
were
used
for
all
other
processed
commodities
The
cancer
risk
estimate
is
1.2
x
10
6
for
the
general
U.
S.
population.
For
cancer
dietary
risk
estimates,
the
Agency
is
generally
concerned
with
cancer
risks
that
exceed
the
range
of
1
x
10
6
.
The
following
conservative
assumptions
were
used
in
the
cancer
dietary
exposure
assessment:
The
percent
import
consumption
information
used
for
apple,
grape
and
tomato
commodities
assume
that
100%
of
these
imported
commodities
are
treated
with
tolylfluanid.
The
calculated
ARs
are
based
on
field
trial
data,
submitted
by
the
registrant
to
support
tolerances.
Field
trial
residue
data
are
generally
considered
by
the
Agency
as
providing
an
upper
end
scenario
of
possible
residues
and
are
more
suited
to
the
requirements
of
tolerance
setting,
because
it
requires
highest
rates
of
application
and
shortest
PHI,
than
to
the
requirements
of
dietary
exposure
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and
Regulations
assessment
(when
a
more
realistic
estimate
is
desired).
With
additional
refinements
to
the
dietary
exposure
assessment
(i.
e.,
country
specific
percent
import
consumption
data
and/
or
monitoring
data
(including
metabolites
of
concern)
the
Agency
expects
the
estimated
cancer
risk
to
be
significantly
lower.
iv.
Anticipated
residue
and
%CT.
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.
Adequate
reliable
information
was
not
available
on
the
fraction
of
imported
grape,
apple,
hop,
and
tomato
which
were
treated
with
tolylfluanid,
therefore
the
Agency
assumed
that
all
these
commodities
were
treated
(100%
CT).
In
addition,
the
Agency
must
provide
for
periodic
evaluation
of
any
estimates
used.
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
%CT
as
required
by
section
408(
b)(
2)(
F)
of
the
FFDCA,
EPA
may
require
registrants
to
submit
data
on
%CT.
The
Agency
used
%CT
information
as
follows:
Since
the
tolerances
being
established
are
for
imported
commodities
only
and
a
petition
for
domestic
use
of
tolyfluanid
is
not
currently
pending
with
EPA,
the
Agency
analyzed
the
amount
of
imported
apple,
grape,
hop,
and
tomato,
relative
to
domestic
production,
and
derived
a
``
percent
crop
imported''
figure
for
each
commodity.
The
Agency
based
this
analysis
on
import
and
domestic
production
data
available
from
the
USDA
for
the
years
1995
through
1999.
The
proportion
of
imports
relative
to
domestic
production
for
each
of
the
commodities
are
as
follows:
Fresh
apple—
5.6%;
apple
juice—
56.4%;
canned
apple—
0.1%;
fresh
grape—
0.2%,
grape
juice—
43.4%;
fresh
tomato—
16.4%;
and
processed
tomato—
4.1%.
The
Agency's
analysis
assumed
100%
for
hop.
Tolylfluanid
is
currently
only
registered
for
use
in
a
small
number
of
European
countries,
however,
the
estimates
stated
in
this
unit
reflect
total
imports
of
these
commodities
into
the
United
States,
not
just
imports
from
Europe.
Therefore,
the
values
used
in
the
Agency's
risk
assessment
assume
that
all
imported
commodities
contain
residues
of
tolyfluanid.
These
assumptions
fulfill
Condition
1
by
overestimating
the
portion
of
imported
apple,
grape,
hop,
and
tomato
with
tolylfluanid
residues.
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.
2.
Dietary
exposure
from
drinking
water.
Residues
in
drinking
water
are
not
expected
to
result
as
a
consequence
of
establishing
an
import
tolerance
for
tolylfluanid
residues
in
or
on
apple,
grape,
hop,
and
tomato.
Tolylfluanid
is
not
registered
for
use
in
the
United
States.
Therefore,
exposure
through
drinking
water
is
unlikely.
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).
Tolylfluanid
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
tolylfluanid
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,
tolylfluanid
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
tolylfluanid
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
10
fold
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
quantitative
or
qualitative
evidence
of
increased
susceptibility
following
in
utero
exposure
in
the
prenatal
developmental
study
in
rats.
Although
there
is
qualitative
evidence
of
increased
susceptibility
in
the
prenatal
developmental
study
in
rabbits
and
in
the
2
generation
reproduction
study
in
rats,
the
Agency
did
not
identify
any
residual
uncertainties
after
establishing
toxicity
endpoints
and
traditional
UFs
to
be
used
in
the
risk
assessment
of
tolylfluanid.
3.
Conclusion.
There
is
a
complete
toxicity
data
base
for
tolylfluanid
and
exposure
data
are
complete
or
are
estimated
based
on
data
that
reasonably
accounts
for
potential
exposures.
The
RfDs
established
are
protective
of
pre/
post
natal
toxicity
following
acute
and
chronic
exposures.
The
Agency
therefore
concluded
that
no
Special
FQPA
FS
is
necessary
to
protect
the
safety
of
infants
and
children
in
assessing
tolylfluanid
exposure
and
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risks.
However,
a
FQPA
factor
in
the
form
of
data
base
UF
(UFDB)
of
3x
was
applied
to
the
acute
RfDs
and
chronic
RfDs
to
account
for
the
comparative
thyroid
assay
(adult
versus
young
animals)
data
requirement.
3X
is
adequate
in
this
case
since
the
observed
thyroid
hormone
changes
that
necessitated
the
additional
study
occurred
at
a
dose
level
more
than
three
fold
higher
than
the
dose
levels
(based
on
developmental
and
reproductive
toxicity)
used
as
the
basis
for
endpoints
for
risk
assessment.
Thus,
use
of
an
additional
3X
FQPA
SF
will
provide
at
least
a
10X
margin
of
safety
regarding
the
effects
for
which
there
is
some
uncertainty
and
for
which
additional
data
is
required.
TABLE
5.—
ADDITIONAL
FQPA
SAFETY
FACTOR
LOAEL
to
NOAEL
(UFL)
Subchronic
to
Chronic
(UFS)
Incomplete
Data
base
(UFDB)
Special
FQPA
Safety
Factor
(Hazard
and
Exposure)
Magnitude
of
factor
1X
1X
3X
1X
Rationale
for
the
factor
No
LOAEL
to
NOAEL
extrapolations
performed
No
subchronic
to
chronic
extrapolations
performed
Lack
of
comparative
thyroid
assay
(adult
versus
young
animals
No
residual
uncertainties
regarding
pre
or
post
natal
toxicity
or
completeness
of
the
toxicity
or
exposure
data
bases
Endpoints
to
which
the
factor
is
applied
Not
applicable
(NA)
NA
All
dietary
exposure
scenarios
NA
E.
Aggregate
Risks
and
Determination
of
Safety
1.
Acute
risk.
Using
the
exposure
assumptions
discussed
in
this
unit
for
acute
exposure,
the
acute
dietary
exposure
from
food
to
tolylfluanid
will
occupy
31%
of
the
aPAD
for
the
U.
S.
population,
20%
of
the
aPAD
for
females
13
years
and
older,
100%
of
the
aPAD
for
infants
<
1year
old,
and
94%
of
the
aPAD
for
children
between
7
and
12
years
old.
In
addition,
there
is
no
potential
for
acute
dietary
exposure
to
tolylfluanid
in
drinking
water.
Although
this
risk
assessment
projects
that
infants
under
1
year
of
age
will
receive
the
maximum
safe
exposure,
for
the
reasons
detailed
in
this
unit,
this
assessment
is
likely
to
substantially
overstate
risk.
2.
Chronic
risk.
Using
the
exposure
assumptions
described
in
this
unit
for
chronic
exposure,
EPA
has
concluded
that
exposure
to
tolylfluanid
from
food
will
utilize
3%
of
the
cPAD
for
the
U.
S.
population,
13%
of
the
cPAD
for
infants
<
1
year
old,
and
14%
of
the
cPAD
for
children
between
1
and
6
years
old.
There
are
no
residential
uses
for
tolylfluanid
that
result
in
chronic
residential
exposure
to
tolylfluanid.
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).
Tolylfluanid
is
not
registered
for
use
on
any
sites
that
would
result
in
residential
exposure.
Therefore,
a
short
term
aggregate
risk
was
not
performed.
4.
Intermediate
term
risk.
Tolylfluanid
is
not
registered
for
use
on
any
sites
that
would
result
in
residential
exposure.
Therefore,
an
intermediateterm
aggregate
risk
was
not
performed.
5.
Aggregate
cancer
risk
for
U.
S.
population.
The
cancer
risk
estimate
for
the
general
U.
S.
population
from
tolylfluanid
is
1.2
x
10
6
.
In
general,
the
Agency's
level
of
concern
for
cancer
exposure
is
for
risks
in
the
range
of
1
x
10
6
and
this
risk
estimate
is
comfortably
with
this
range.
Moreover,
several
conservative
assumptions
were
included
in
the
assessment
(enumerated
in
Unit
III.
C.
1.,
Dietary
exposure
from
food
and
feed
uses).
With
additional
refinements
to
the
dietary
exposure
assessment
(i.
e.,
country
specific
percent
import
consumption
data
and/
or
monitoring
data
(including
metabolites
of
concern),
the
Agency
expects
the
cancer
risk
to
be
substantially
lower.
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
tolylfluanid
residues.
IV.
Other
Considerations
A.
Analytical
Enforcement
Methodology
For
tolylfluanid
in/
on
apple,
grape,
hop,
and
tomato,
the
submitted
independent
laboratory
validation
(ILV)
using
a
gas
chromatograph
(GC)/
thermal
ionization
detector
(TID)
procedure
designated
as
Method
00441
and
entitled
Determination
of
Tolylfluanid
in/
on
Various
Raw
Agricultural
and
Processed
Commodities
has
been
received
and
the
method
has
been
forwarded
to
the
Agency's
laboratory
for
validation.
The
petitioner
will
be
required
to
make
any
modifications
or
revisions
to
the
proposed
method
resulting
from
EPA's
validation.
The
petitioners
submitted
the
multiresidue
data
concerning
the
recovery
of
tolylfluanid
residues
using
the
Food
and
Drug
Administration
(FDA)
MRM
protocols
(PAM
Vol.
I)
and
following
modified
cleanup
procedures.
These
results
indicate
that
tolylfluanid
is
likely
to
be
recovered
through
FDA
MRM
Protocols
D
and
E.
The
results
have
been
forwarded
to
the
FDA
for
inclusion
in
the
Pesticide
Analytical
Method
Volume
I.
Prior
to
publication
and
upon
request,
the
method
will
be
available
from
the
Analytical
Chemistry
Branch
(ACB),
BEAD
(75053),
Environmental
Science
Center,
701
Mapes
Rd.,
Ft.
George
C.
Meade,
MD
20755–
5350.
Contact
Francis
D.
Griffith,
Jr.,
telephone
number:
(410)
305–
2905;
e
mail
address:
griffith.
francis@
epa.
gov.
The
analytical
standards
are
also
available
from
the
EPA
National
Standard
Repository
at
the
same
location.
Based
on
the
proposed
uses,
a
residue
enforcement
method
for
livestock
commodities
is
not
necessary
at
this
time.
B.
International
Residue
Limits
There
are
no
Canadian
or
Mexican
MRLs
established
for
tolylfluanid
residues
in/
on
crop
commodities.
The
Codex
Alimentarius
Commission
has
established
MRLs
for
tolylfluanid
residues
in/
on
various
commodities,
including
currant
at
5
ppm,
gherkin
at
2
ppm,
lettuce
head
at
1
ppm,
pome
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fruits
at
5
ppm,
strawberry
at
3
ppm,
and
tomato
at
2
ppm.
The
Codex
MRLs
are
expressed
in
terms
of
tolylfluanid
per
se.
Although
the
submitted
residue
data
support
the
proposed
tolerance
of
1.0
ppm
on
tomato,
the
Agency
is
establishing
this
tolerance
at
2.0
ppm
in
order
to
harmonize
with
the
current
Codex
MRL.
V.
Conclusion
Therefore,
the
tolerance
is
established
for
residues
of
tolylfluanid,
(1,1
dichloro
N[(
dimethylamino)
sulfonyl]
1
fluoro
N(
4
methylphenyl)
methanesulfenamide),
in
or
on
apple
at
5
ppm,
grape
at
11
ppm,
hop
at
30
ppm,
and
tomato
at
2
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–
0216
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
November
25,
2002.
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.
2.
Mail
your
copies,
identified
by
docket
ID
number
OPP–
2002–
0216,
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.
2.
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
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and
Regulations
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
and
pests,
Reporting
and
recordkeeping
requirements.
Dated:
September
13,
2002.
James
Jones,
Acting
Director,
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
180.584
is
added
to
subpart
C
to
read
as
follows:
§
180.584
Tolylfluanid,
tolerances
for
residues.
(a)
General.
Tolerances
are
established
for
residues
of
tolylfluanid,
1,1
dichloro
N[(
dimethylamino)
sulfonyl
1
fluoro
N(
4
methylphenyl)
methanesulfenamide
in
or
on
the
following
commodities.
Commodity
Parts
per
million
Apple
1
..................................................................................................................
5.0
Grape
1
.................................................................................................................
11
Hop
1
.....................................................................................................................
30
Tomato
1
...............................................................................................................
2.0
1
No
U.
S.
registration
as
of
August
31,
2002.
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and
Regulations
(b)
Section
18
emergency
exemptions.
[Reserved]
(c)
Tolerances
with
regional
registrations.
[Reserved]
(d)
Indirect
or
inadvertent
residues.
[Reserved]
[FR
Doc.
02–
24094
Filed
9–
24–
02;
8:
45
am]
BILLING
CODE
6560–
50–
S
ENVIRONMENTAL
PROTECTION
AGENCY
40
CFR
Part
180
[OPP–
2002–
0234;
FRL–
7198–
3]
Fluroxypyr
1
methylheptyl
ester;
Pesticide
Tolerances
for
Emergency
Exemptions
AGENCY:
Environmental
Protection
Agency
(EPA).
ACTION:
Final
rule.
SUMMARY:
This
regulation
establishes
time
limited
tolerances
for
combined
residues
of
fluroxypyr
[1
methylheptyl
ester
1
methylheptyl
((
4
amino
3,5
dichloro
6
fluoro
2
pyridinyl)
oxy)
acetate]
and
its
metabolite
fluroxypyr
[((
4
amino
3,5
dichloro
6
fluoro
2
pyridinyl)
oxy)
acetic
acid]
in
or
on
sorghum,
grain
at
0.035
parts
per
million
(ppm);
sorghum,
forage
at
2.0
ppm;
and
sorghum,
grain,
stover
at
4.0
ppm.
This
action
is
in
connection
with
a
crisis
exemption
declared
by
the
state
of
Kansas
under
section
18
of
the
Federal
Insecticide,
Fungicide,
and
Rodenticide
Act
(FIFRA)
authorizing
use
of
the
pesticide
on
sorghum.
This
regulation
establishes
maximum
permissible
levels
for
residues
of
fluroxypyr
1
methylheptyl
ester
and
its
metabolite,
all
expressed
as
fluroxypyr
in
these
food
commodities.
The
tolerances
will
expire
and
are
revoked
on
December
31,
2005.
DATES:
This
regulation
is
effective
September
25,
2002.
Objections
and
requests
for
hearings,
identified
by
docket
ID
number
OPP–
2002–
0234,
must
be
received
on
or
before
November
25,
2002.
ADDRESSES:
Written
objections
and
hearing
requests
may
be
submitted
by
mail,
in
person,
or
by
courier.
Please
follow
the
detailed
instructions
for
each
method
as
provided
in
Unit
VII.
of
the
SUPPLEMENTARY
INFORMATION.
To
ensure
proper
receipt
by
EPA,
your
objections
and
hearing
requests
must
identify
docket
ID
number
OPP–
2002–
0234
in
the
subject
line
on
the
first
page
of
your
response.
FOR
FURTHER
INFORMATION
CONTACT:
By
mail:
Libby
Pemberton,
Registration
Division
(7505C),
Office
of
Pesticide
Programs,
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460–
0001;
telephone
number:
(703)
308–
9364;
e
mail
address:
sec–
18–
Mailbox@
epamail.
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
categories
and
entities
may
include,
but
are
not
limited
to:
Categories
NAICS
Codes
Examples
of
Potentially
Affected
Entities
Industry
111
Crop
production
112
Animal
production
311
Food
manufacturing
32532
Pesticide
manufacturing
This
listing
is
not
intended
to
be
exhaustive,
but
rather
provides
a
guide
for
readers
regarding
entities
likely
to
be
affected
by
this
action.
Other
types
of
entities
not
listed
in
the
table
could
also
be
affected.
The
North
American
Industrial
Classification
System
(NAICS)
codes
have
been
provided
to
assist
you
and
others
in
determining
whether
or
not
this
action
might
apply
to
certain
entities.
If
you
have
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
Additional
Information,
Including
Copies
of
This
Document
and
Other
Related
Documents?
1.
Electronically.
You
may
obtain
electronic
copies
of
this
document,
and
certain
other
related
documents
that
might
be
available
electronically,
from
the
EPA
Internet
home
page
at
http://
www.
epa.
gov/.
To
access
this
document,
on
the
home
page
select
``
Laws
and
Regulations,
''
``
Regulations
and
Proposed
Rules,
''
and
then
look
up
the
entry
for
this
document
under
the
``
Federal
Register—
Environmental
Documents.
''
You
can
also
go
directly
to
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.
2.
In
person.
The
Agency
has
established
an
official
record
for
this
action
under
docket
ID
number
OPP–
2002–
0234.
The
official
record
consists
of
the
documents
specifically
referenced
in
this
action,
and
other
information
related
to
this
action,
including
any
information
claimed
as
Confidential
Business
Information
(CBI).
This
official
record
includes
the
documents
that
are
physically
located
in
the
docket,
as
well
as
the
documents
that
are
referenced
in
those
documents.
The
public
version
of
the
official
record
does
not
include
any
information
claimed
as
CBI.
The
public
version
of
the
official
record,
which
includes
printed,
paper
versions
of
any
electronic
comments
submitted
during
an
applicable
comment
period
is
available
for
inspection
in
the
Public
Information
and
Records
Integrity
Branch
(PIRIB),
Rm.
119,
Mall
#2,
1921
Jefferson
Davis
Hwy.,
Arlington,
VA,
from
8:
30
a.
m.
to
4
p.
m.,
Monday
through
Friday,
excluding
legal
holidays.
The
PIRIB
telephone
number
is
(703)
305–
5805.
II.
Background
and
Statutory
Findings
EPA,
on
its
own
initiative,
in
accordance
with
sections
408(
e)
and
408(
l)(
6)
of
the
Federal
Food,
Drug,
and
Cosmetic
Act
(FFDCA),
21
U.
S.
C.
346a,
is
establishing
tolerances
for
combined
residues
of
the
herbicide
fluroxypyr
1
methylheptyl
ester,
[1
methylheptyl
((
4
amino
3,5
dichloro
6
fluoro
2
pyridinyl)
oxy)
acetate]
and
its
metabolite
fluroxypyr
[((
4
amino
3,5
dichloro
6
fluoro
2
pyridinyl)
oxy)
acetic
acid],
in
or
on
sorghum,
grain
at
0.035
ppm;
sorghum,
forage
at
2.0
ppm;
and
sorghum,
grain,
stover
at
4.0
ppm.
These
tolerances
will
expire
and
are
revoked
on
December
31,
2005.
EPA
will
publish
a
document
in
the
Federal
Register
to
remove
the
revoked
tolerances
from
the
Code
of
Federal
Regulations.
Section
408(
l)(
6)
of
the
FFDCA
requires
EPA
to
establish
a
time
limited
tolerance
or
exemption
from
the
requirement
for
a
tolerance
for
pesticide
chemical
residues
in
food
that
will
result
from
the
use
of
a
pesticide
under
an
emergency
exemption
granted
by
EPA
under
section
18
of
FIFRA.
Such
tolerances
can
be
established
without
providing
notice
or
period
for
public
comment.
EPA
does
not
intend
for
its
actions
on
section
18
related
tolerances
to
set
binding
precedents
for
the
application
of
section
408
and
the
new
safety
standard
to
other
tolerances
and
exemptions.
Section
408(
e)
of
the
FFDCA
allows
EPA
to
establish
a
tolerance
or
an
exemption
from
the
requirement
of
a
tolerance
on
its
own
initiative,
i.
e.,
without
having
received
any
petition
from
an
outside
party.
Section
408(
b)(
2)(
A)(
i)
of
the
FFDCA
allows
EPA
to
establish
a
tolerance
(the
legal
limit
for
a
pesticide
chemical
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| epa | 2024-06-07T20:31:43.222381 | regulations | {
"license": "Public Domain",
"url": "https://downloads.regulations.gov/EPA-HQ-OPP-2002-0216-0001/content.txt"
} |
EPA-HQ-OPP-2002-0218-0001 | Notice | "2002-10-31T05:00:00" | Tolerance Petitions for Pesticide on Food /Feed Crops and New Inert Ingredients; Renewal of
Pesticide Information Collection Activities and Request for Comment | 66392
Federal
Register
/
Vol.
67,
No.
211
/
Thursday,
October
31,
2002
/
Notices
requirements,
you
may
complete
your
designation
application
form
on
line,
print
the
form,
and
attach
your
narrative
waiver
request(
s)
to
the
printed
form
and
mail
both
to
the
address
in
the
next
paragraph.
Mail
your
Designation
of
Eligibility
application
request
to:
Ms.
Darlene
B.
Collins,
Team
Leader,
Institutional
Development
and
Undergraduate
Education
Service,
U.
S.
Department
of
Education,
1990
K
Street,
NW.,
Room
6032,
Request
for
Eligibility
Designation,
Washington,
DC
20202
8513.
Applicable
Regulations:
(
a)
The
Education
Department
General
Administrative
Regulations
in
34
CFR
parts
74,
75,
77,
79,
82,
85,
86,
97,
98,
and
99.
(
b)
The
regulations
for
the
Title
III
Part
A
Programs
in
34
CFR
part
607,
and
for
the
Title
V
Program
in
34
CFR
part
606.
For
Applications
and
Further
Information
Contact:
Thomas
M.
Keyes,
Margaret
A.
Wheeler
or
Ellen
Sealey,
Institutional
Development
and
Undergraduate
Education
Service,
U.
S.
Department
of
Education,
1990
K
Street,
Room
6049,
Request
for
Eligibility
Designation,
Washington,
DC
20202
8513.
Mr.
Keyes'
telephone
number
is
(
202)
502
7577.
Ms.
Wheeler's
telephone
number
is
(
202)
502
7583.
Ms.
Sealey's
telephone
number
is
(
202)
502
7580.
Mr.
Keyes,
Ms.
Wheeler
and
Ms.
Sealey
may
be
reached
via
Internet:
thomas.
keyes@
ed.
gov,
margaret.
wheeler@
ed.
gov,
ellen.
sealey@
ed.
gov.
If
you
use
a
telecommunications
device
for
the
deaf
(
TDD),
you
may
call
the
Federal
Information
Relay
Service
(
FIRS)
at
1
800
877
8339.
Individuals
with
disabilities
may
obtain
this
document
in
an
alternative
format
(
e.
g.,
Braille,
large
print,
audio
tape,
or
computer
diskette)
on
request
to
the
contact
persons
listed
under
For
Applications
and
Further
Information
Contact.
Individuals
with
disabilities
may
obtain
a
copy
of
the
application
package
in
an
alternative
format
by
contacting
those
persons.
However,
the
Department
is
not
able
to
reproduce
in
an
alternative
format
the
standard
forms
included
in
the
application
package.
Electronic
Access
to
This
Document
You
may
view
this
document,
as
well
as
all
other
Department
of
Education
documents
published
in
the
Federal
Register,
in
text
or
Adobe
Portable
Document
Format
(
PDF)
on
the
Internet
at
the
following
site:
www.
ed.
gov/
legislation/
FedRegister.
To
use
PDF,
you
must
have
Adobe
Acrobat
Reader,
which
is
available
free
at
this
site.
If
you
have
questions
about
using
the
PDF,
call
the
U.
S.
Government
Printing
Office
(
GPO),
toll
free,
at
1
888
293
6498;
or
in
the
Washington,
DC
area
at
(
202)
512
1530.
Note:
The
official
version
of
this
document
is
the
document
published
in
the
Federal
Register.
Free
Internet
access
to
the
official
edition
of
the
Federal
Register
and
the
Code
of
Federal
Regulations
is
available
on
GPO
Access
at:
http://
www.
access.
gpo.
gov/
nara/
index.
html
Program
Authority:
20
U.
S.
C.
1057
1059d,
1101
1103g.
Dated:
October
28,
2002.
Sally
L.
Stroup,
Assistant
Secretary,
Office
of
Postsecondary
Education.
[
FR
Doc.
02
27697
Filed
10
30
02;
8:
45
am]
BILLING
CODE
4000
01
P
ENVIRONMENTAL
PROTECTION
AGENCY
[
OPP
2002
0218;
FRL
7278
2]
Tolerance
Petitions
for
Pesticides
on
Food/
Feed
Crops
and
New
Inert
Ingredients;
Renewal
of
Pesticide
Information
Collection
Activities
and
Request
for
Comments
AGENCY:
Environmental
Protection
Agency
(
EPA).
ACTION:
Notice.
SUMMARY:
In
compliance
with
the
Paperwork
Reduction
Act
(
PRA)
(
44
U.
S.
C.
3501
et
seq.)
this
notice
announces
that
EPA
is
seeking
public
comment
on
the
following
Information
Collection
Request
(
ICR):
Tolerance
Petitions
for
Pesticides
on
Food/
Feed
Crops
and
New
Inert
Ingredients
(
EPA
ICR
No.
0597.08,
OMB
Control
No.
2070
0024).
This
is
a
request
to
renew
an
existing
ICR
that
is
currently
approved
and
due
to
expire
January
31,
2003.
The
ICR
describes
the
nature
of
the
information
collection
activity
and
its
expected
burden
and
costs.
Before
submitting
this
ICR
to
the
Office
of
Management
and
Budget
(
OMB)
for
review
and
approval
under
the
PRA,
EPA
is
soliciting
comments
on
specific
aspects
of
the
collection.
DATES:
Written
comments,
identified
by
the
docket
ID
number
OPP
2002
0218,
must
be
received
on
or
before
December
30,
2002.
ADDRESSES:
Comments
may
be
submitted
electronically,
by
mail,
or
through
hand
delivery/
courier.
Follow
the
detailed
instructions
as
provided
in
Unit
III.
of
the
SUPPLEMENTARY
INFORMATION.
FOR
FURTHER
INFORMATION
CONTACT:
Nancy
Vogel,
Field
and
External
Affairs
Division
(
7506C),
Office
of
Pesticide
Programs,
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460
0001;
telephone
number:
(
703)
305
6475;
fax
number:
(
703)
305
5884;
e
mail
address:
vogel.
nancy@
epa.
gov.
SUPPLEMENTARY
INFORMATION:
I.
Does
this
Action
Apply
to
Me?
You
may
be
potentially
affected
by
this
action
if
you
are
a
business
engaged
in
the
manufacturing
of
pesticides
and
other
agricultural
chemicals.
Potentially
affected
entities
may
include,
but
are
not
limited
to:
Pesticide
and
other
agricultural
chemical
manufacturing
(
NAICS
325320),
e.
g.,
Businesses
engaged
in
the
manufacture
of
pesticides
and
who
file
a
petition
asking
the
Agency
to
take
a
specific
tolerance
action.
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
above
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.
To
determine
whether
you
or
your
business
may
be
affected
by
this
action,
you
should
carefully
examine
the
applicability
provisions
in
the
Federal
Insecticide,
Fungicide,
and
Rodenticide
Act
(
FIFRA),
the
Food
Quality
Protection
Act
of
1996,
and
section
408
of
the
Federal
Food,
Drug,
and
Cosmetic
Act
(
FFDCA).
If
you
have
any
questions
regarding
the
applicability
of
this
action
to
a
particular
entity,
consult
the
person
listed
under
FOR
FURTHER
INFORMATION
CONTACT.
II.
How
Can
I
Get
Copies
of
This
Document
and
Other
Related
Information?
A.
Docket
EPA
has
established
an
official
public
docket
for
this
action
under
docket
identification
(
ID)
number
OPP
2002
0218.
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
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66393
Federal
Register
/
Vol.
67,
No.
211
/
Thursday,
October
31,
2002
/
Notices
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.
B.
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/.
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.
Certain
types
of
information
will
not
be
placed
in
the
EPA
Dockets.
Information
claimed
as
CBI
and
other
information
whose
disclosure
is
restricted
by
statute,
which
is
not
included
in
the
official
public
docket,
will
not
be
available
for
public
viewing
in
EPA's
electronic
public
docket.
EPA's
policy
is
that
copyrighted
material
will
not
be
placed
in
EPA's
electronic
public
docket
but
will
be
available
only
in
printed,
paper
form
in
the
official
public
docket.
To
the
extent
feasible,
publicly
available
docket
materials
will
be
made
available
in
EPA's
electronic
public
docket.
When
a
document
is
selected
from
the
index
list
in
EPA
Dockets,
the
system
will
identify
whether
the
document
is
available
for
viewing
in
EPA's
electronic
public
docket.
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
II.
A.
EPA
intends
to
work
towards
providing
electronic
access
to
all
of
the
publicly
available
docket
materials
through
EPA's
electronic
public
docket.
For
public
commenters,
it
is
important
to
note
that
EPA's
policy
is
that
public
comments,
whether
submitted
electronically
or
in
paper,
will
be
made
available
for
public
viewing
in
EPA's
electronic
public
docket
as
EPA
receives
them
and
without
change,
unless
the
comment
contains
copyrighted
material,
CBI,
or
other
information
whose
disclosure
is
restricted
by
statute.
When
EPA
identifies
a
comment
containing
copyrighted
material,
EPA
will
provide
a
reference
to
that
material
in
the
version
of
the
comment
that
is
placed
in
EPA's
electronic
public
docket.
The
entire
printed
comment,
including
the
copyrighted
material,
will
be
available
in
the
public
docket.
Public
comments
submitted
on
computer
disks
that
are
mailed
or
delivered
to
the
docket
will
be
transferred
to
EPA's
electronic
public
docket.
Public
comments
that
are
mailed
or
delivered
to
the
docket
will
be
scanned
and
placed
in
EPA's
electronic
public
docket.
Where
practical,
physical
objects
will
be
photographed,
and
the
photograph
will
be
placed
in
EPA's
electronic
public
docket
along
with
a
brief
description
written
by
the
docket
staff.
C.
Fax
on
Demand
Using
a
faxphone
call
(
202)
564
3119
and
select
item
6094
for
a
copy
of
the
ICR.
III.
How
Can
I
Respond
to
this
Action?
A.
How
and
To
Whom
Do
I
Submit
Comments?
You
may
submit
comments
electronically,
by
mail,
or
through
hand
delivery/
courier.
To
ensure
proper
receipt
by
EPA,
identify
the
appropriate
docket
ID
number
in
the
subject
line
on
the
first
page
of
your
comment.
Please
ensure
that
your
comments
are
submitted
within
the
specified
comment
period.
Comments
received
after
the
close
of
the
comment
period
will
be
marked
``
late.''
EPA
is
not
required
to
consider
these
late
comments.
If
you
wish
to
submit
CBI
or
information
that
is
otherwise
protected
by
statute,
please
follow
the
instructions
in
Unit
III.
B.
Do
not
use
EPA
Dockets
or
e
mail
to
submit
CBI
or
information
protected
by
statute.
1.
Electronically.
If
you
submit
an
electronic
comment
as
prescribed
in
this
unit,
EPA
recommends
that
you
include
your
name,
mailing
address,
and
an
email
address
or
other
contact
information
in
the
body
of
your
comment.
Also
include
this
contact
information
on
the
outside
of
any
disk
or
CD
ROM
you
submit,
and
in
any
cover
letter
accompanying
the
disk
or
CD
ROM.
This
ensures
that
you
can
be
identified
as
the
submitter
of
the
comment
and
allows
EPA
to
contact
you
in
case
EPA
cannot
read
your
comment
due
to
technical
difficulties
or
needs
further
information
on
the
substance
of
your
comment.
EPA's
policy
is
that
EPA
will
not
edit
your
comment,
and
any
identifying
or
contact
information
provided
in
the
body
of
a
comment
will
be
included
as
part
of
the
comment
that
is
placed
in
the
official
public
docket,
and
made
available
in
EPA's
electronic
public
docket.
If
EPA
cannot
read
your
comment
due
to
technical
difficulties
and
cannot
contact
you
for
clarification,
EPA
may
not
be
able
to
consider
your
comment.
i.
EPA
Dockets.
Your
use
of
EPA's
electronic
public
docket
to
submit
comments
to
EPA
electronically
is
EPA's
preferred
method
for
receiving
comments.
Go
directly
to
EPA
Dockets
at
http://
www.
epa.
gov/
edocket,
and
follow
the
online
instructions
for
submitting
comments.
Once
in
the
system,
select
``
search,''
and
then
key
in
docket
ID
number
OPP
2002
0218.
The
system
is
an
``
anonymous
access''
system,
which
means
EPA
will
not
know
your
identity,
e
mail
address,
or
other
contact
information
unless
you
provide
it
in
the
body
of
your
comment.
ii.
E
mail.
Comments
may
be
sent
by
e
mail
to
opp
docket@
epa.
gov,
Attention:
Docket
ID
Number
OPP
2002
0218.
In
contrast
to
EPA's
electronic
public
docket,
EPA's
e
mail
system
is
not
an
``
anonymous
access''
system.
If
you
send
an
e
mail
comment
directly
to
the
docket
without
going
through
EPA's
electronic
public
docket,
EPA's
e
mail
system
automatically
captures
your
e
mail
address.
E
mail
addresses
that
are
automatically
captured
by
EPA's
e
mail
system
are
included
as
part
of
the
comment
that
is
placed
in
the
official
public
docket,
and
made
available
in
EPA's
electronic
public
docket.
iii.
Disk
or
CD
ROM.
You
may
submit
comments
on
a
disk
or
CD
ROM
that
you
mail
to
the
mailing
address
identified
in
Unit
III.
A.
These
electronic
submissions
will
be
accepted
in
WordPerfect
or
ASCII
file
format.
Avoid
the
use
of
special
characters
and
any
form
of
encryption.
2.
By
mail.
Send
your
comments
to:
Public
Information
and
Records
Integrity
Branch
(
PIRIB),
Office
of
Pesticide
Programs
(
OPP),
Environmental
Protection
Agency
(
7502C),
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC,
20460
0001,
Attention:
Docket
ID
Number
OPP
2002
0218.
3.
By
hand
delivery
or
courier.
Deliver
your
comments
to:
Public
Information
and
Records
Integrity
Branch
(
PIRIB),
Office
of
Pesticide
Programs
(
OPP),
Environmental
Protection
Agency,
Rm.
119,
Crystal
Mall
#
2,
1921
Jefferson
Davis
Hwy.,
Arlington,
VA.,
Attention:
Docket
ID
Number
OPP
2002
0218.
Such
deliveries
are
only
accepted
during
the
docket's
normal
hours
of
operation
as
identified
in
Unit
II.
A.
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31,
2002
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Notices
B.
How
Should
I
Submit
CBI
to
the
Agency?
Do
not
submit
information
that
you
consider
to
be
CBI
electronically
through
EPA's
electronic
public
docket
or
by
e
mail.
You
may
claim
information
that
you
submit
to
EPA
as
CBI
by
marking
any
part
or
all
of
that
information
as
CBI
(
if
you
submit
CBI
on
disk
or
CD
ROM,
mark
the
outside
of
the
disk
or
CD
ROM
as
CBI
and
then
identify
electronically
within
the
disk
or
CD
ROM
the
specific
information
that
is
CBI).
Information
so
marked
will
not
be
disclosed
except
in
accordance
with
procedures
set
forth
in
40
CFR
part
2.
In
addition
to
one
complete
version
of
the
comment
that
includes
any
information
claimed
as
CBI,
a
copy
of
the
comment
that
does
not
contain
the
information
claimed
as
CBI
must
be
submitted
for
inclusion
in
the
public
docket
and
EPA's
electronic
public
docket.
If
you
submit
the
copy
that
does
not
contain
CBI
on
disk
or
CD
ROM,
mark
the
outside
of
the
disk
or
CD
ROM
clearly
that
it
does
not
contain
CBI.
Information
not
marked
as
CBI
will
be
included
in
the
public
docket
and
EPA's
electronic
public
docket
without
prior
notice.
If
you
have
any
questions
about
CBI
or
the
procedures
for
claiming
CBI,
please
consult
the
person
listed
under
FOR
FURTHER
INFORMATION
CONTACT.
C.
What
Should
I
Consider
when
I
Prepare
My
Comments
for
EPA?
You
may
find
the
following
suggestions
helpful
for
preparing
your
comments:
1.
Explain
your
views
as
clearly
as
possible.
2.
Describe
any
assumptions
that
you
used.
3.
Provide
copies
of
any
technical
information
and/
or
data
you
used
that
support
your
views.
4.
If
you
estimate
potential
burden
or
costs,
explain
how
you
arrived
at
the
estimate
that
you
provide.
5.
Provide
specific
examples
to
illustrate
your
concerns.
6.
Offer
alternative
ways
to
improve
the
collection
activity.
7.
Make
sure
to
submit
your
comments
by
the
deadline
in
this
notice.
8.
To
ensure
proper
receipt
by
EPA,
be
sure
to
identify
the
docket
ID
number
assigned
to
this
action
in
the
subject
line
on
the
first
page
of
your
response.
You
may
also
provide
the
name,
date,
and
Federal
Register
citation.
D.
What
Information
Is
EPA
Particularly
Interested
in?
Pursuant
to
section
3506(
c)(
2)(
A)
of
the
PRA,
EPA
specifically
solicits
comments
and
information
to
enable
it
to:
1.
Evaluate
whether
the
proposed
collections
of
information
are
necessary
for
the
proper
performance
of
the
functions
of
the
Agency,
including
whether
the
information
will
have
practical
utility.
2.
Evaluate
the
accuracy
of
the
Agency's
estimates
of
the
burdens
of
the
proposed
collections
of
information.
3.
Enhance
the
quality,
utility,
and
clarity
of
the
information
to
be
collected.
4.
Minimize
the
burden
of
the
collections
of
information
on
those
who
are
to
respond,
including
through
the
use
of
appropriate
automated
or
electronic
collection
technologies
or
other
forms
of
information
technology,
e.
g.,
permitting
electronic
submission
of
responses.
IV.
What
Information
Collection
Activity
or
ICR
Does
This
Action
Apply
to?
EPA
is
seeking
comments
on
the
following
ICR:
Title:
Tolerance
Petitions
for
Pesticides
on
Food/
Feed
Crops
and
New
Inert
Ingredients.
ICR
numbers:
EPA
ICR
No.
0597.08,
OMB
Control
No.
2070
0024.
ICR
status:
This
ICR
is
a
renewal
of
an
existing
ICR
that
is
currently
approved
by
OMB
and
is
due
to
expire
January
31,
2003.
Abstract:
This
information
collection
will
enable
EPA
to
collect
adequate
data
to
support
the
establishment
of
pesticide
tolerances
pursuant
to
section
408
of
the
FFDCA.
A
pesticide
may
not
be
used
on
food
or
feed
crops
unless
EPA
has
established
a
tolerance
for
the
pesticide
residues
on
that
crop,
or
established
an
exemption
from
the
requirement
to
have
a
tolerance.
It
is
EPA's
responsibility
to
ensure
that
the
maximum
residue
levels
likely
to
be
found
in
or
on
food/
feed
crops
are
safe
for
human
consumption
through
a
careful
review
and
evaluation
of
residue
chemistry
and
toxicology
data.
In
addition,
it
must
ensure
that
adequate
enforcement
of
the
tolerance
can
be
achieved
through
the
testing
of
submitted
analytical
methods.
Once
the
data
are
deemed
adequate
to
support
the
findings,
EPA
will
establish
the
tolerance
or
grant
an
exemption
from
the
requirement
of
a
tolerance.
V.
What
Are
EPA's
Burden
and
Cost
Estimates
for
this
ICR?
Under
the
PRA,
``
burden''
means
the
total
time,
effort,
or
financial
resources
expended
by
persons
to
generate,
maintain,
retain,
or
disclose
or
provide
information
to
or
for
a
Federal
Agency.
For
this
collection
it
includes
the
time
needed
to
review
instructions;
develop,
acquire,
install,
and
utilize
technology
and
systems
for
the
purposes
of
collecting,
validating,
and
verifying
information,
processing
and
maintaining
information,
and
disclosing
and
providing
information;
adjust
the
existing
ways
to
comply
with
any
previously
applicable
instructions
and
requirements;
train
personnel
to
be
able
to
respond
to
a
collection
of
information;
search
data
sources;
complete
and
review
the
collection
of
information;
and
transmit
or
otherwise
disclose
the
information.
The
ICR
provides
a
detailed
explanation
of
this
estimate,
which
is
only
briefly
summarized
in
this
notice.
The
annual
public
burden
for
this
ICR
is
estimated
to
be
258,900
hours.
The
following
is
a
summary
of
the
estimates
taken
from
the
ICR:
Respondents/
affected
entities:
Businesses
engaged
in
the
manufacturing
of
pesticides
and
other
agricultural
chemicals
who
file
a
petition
asking
the
Agency
to
take
a
specific
tolerance
action.
Estimated
total
number
of
potential
respondents:
2,100.
Frequency
of
response:
Annual.
Estimated
total/
average
number
of
responses
for
each
respondent:
3
5.
Estimated
total
annual
burden
hours:
258,900.
Estimated
total
annual
burden
costs:
$
23,435,700.
VI.
Are
There
Changes
in
the
Estimates
From
the
Last
Approval?
The
total
estimated
annual
respondent
cost
for
this
ICR
has
increased
$
1,305,700
(
from
$
22,130,000
to
$
23,435,700),
due
mainly
to
the
update
in
the
loaded
hourly
labor
rates
used
to
calculate
the
costs.
This
increase
is
explained
more
fully
in
the
ICR.
VII.
What
Is
the
Next
Step
in
the
Process
for
This
ICR?
EPA
will
consider
the
comments
received
and
amend
the
ICR
as
appropriate.
The
final
ICR
package
will
then
be
submitted
to
OMB
for
review
and
approval
pursuant
to
5
CFR
1320.12.
EPA
will
issue
another
Federal
Register
notice
pursuant
to
5
CFR
1320.5(
a)(
1)(
iv)
to
announce
the
submission
of
the
ICR
to
OMB
and
the
opportunity
to
submit
additional
comments
to
OMB.
If
you
have
any
questions
about
this
ICR
or
the
approval
process,
please
contact
the
person
listed
under
FOR
FURTHER
INFORMATION
CONTACT.
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2002
/
Notices
List
of
Subjects
Environmental
protection,
Reporting
and
recordkeeping
requirements.
Dated:
October
23,
2002.
Susan
B.
Hazen,
Acting
Assistant
Administrator
for
Prevention,
Pesticides
and
Toxic
Substances.
[
FR
Doc.
02
27704
Filed
10
30
02;
8:
45
am]
BILLING
CODE
6560
50
S
ENVIRONMENTAL
PROTECTION
AGENCY
[
FRL
7402
9]
Notice
of
Request
for
Initial
Proposals
(
IPs)
for
Projects
To
Be
Funded
From
the
Water
Quality
Cooperative
Agreement
Allocation
(
CFDA
66.463
Water
Quality
Cooperative
Agreements)
AGENCY:
Environmental
Protection
Agency
(
EPA).
ACTION:
Notice.
SUMMARY:
EPA
is
soliciting
Initial
Proposals
(
IPs)
from
States,
Tribes,
local
governments,
universities,
non
profits,
and
other
eligible
entities
interested
in
applying
for
Federal
assistance
for
Water
Quality
Cooperative
Agreements
(
CFDA
66.463)
under
the
Clean
Water
Act
(
CWA)
section
104(
b)(
3).
EPA
Headquarters
intends
to
award
an
estimated
$
3.1
million
to
eligible
applicants
through
assistance
agreements
ranging
in
size
from
$
10,000
up
to
$
500,000
for
Water
Quality
Cooperative
Agreements,
which
are
for
unique
and
innovative
projects
that
address
the
requirements
of
the
National
Pollutant
Discharge
Elimination
Systems
(
NPDES)
program
with
special
emphasis
on
wet
weather
activities,
i.
e.,
storm
water,
combined
sewer
overflows,
sanitary
sewer
overflows,
and
concentrated
animal
feeding
operations
as
well
as
projects
that
enhance
the
ability
of
the
regulated
community
to
deal
with
non
traditional
pollution
problems
in
priority
watersheds.
From
the
IPs
received,
EPA
estimates
that
30
to
35
projects
may
be
selected
to
submit
full
applications.
The
Agency
intends
to
make
available
at
least
$
200,000
per
year
of
the
annual
appropriation
for
Water
Quality
Cooperative
Agreements,
from
FY
2001
through
FY
2005,
for
projects
which
address
cooling
water
intake
issues
to
include
technical
and
environmental
studies.
For
FY
2003
it
is
expected
that
$
250,000
will
be
available
for
projects
addressing
cooling
water
intake
issues.
The
Agency
reserves
the
right
to
reject
all
IPs
and
make
no
awards.
DATES:
EPA
will
consider
IPs
received
on
or
before
5
p.
m.
Eastern
Time,
December
30,
2002.
IPs
received
after
the
due
date,
may
be
reviewed
at
EPA's
discretion.
ADDRESSES:
It
is
preferred
that
IPs
be
electronically
mailed
(
E
mailed)
to
WQCA2003@
EPA.
GOV.
If
mailed
through
the
postal
service
or
other
means,
three
copies
should
be
sent
to:
Barry
Benroth,
4204M,
WQCA2003,
U.
S.
Environmental
Protection
Agency,
1200
Pennsylvania
Avenue,
NW.,
Washington,
DC
20460.
The
following
address
must
be
used
for
delivery
of
the
copies
by
an
overnight
delivery
or
courier
service:
Barry
Benroth,
4204M,
WQCA2003,
Phone
202
564
0672,
U.
S.
Environmental
Protection
Agency,
Room
7324
J,
EPA
East,
1201
Constitution
Avenue,
NW.,
Washington,
DC
20004.
FOR
FURTHER
INFORMATION
CONTACT:
Barry
Benroth
by
telephone
at
202
564
0672
or
by
E
mail
at
benroth.
barry@
epa.
gov.
SUPPLEMENTARY
INFORMATION:
Purpose
of
This
Request
Is
for
Initial
Proposals
The
Office
of
Wastewater
Management,
Office
of
Water
at
EPA
Headquarters
is
requesting
IPs
from
States,
Tribes,
local
governments,
nonprofit
organizations
and
other
eligible
entities
under
the
Clean
Water
Act
section
104(
b)(
3)
for
unique
and
innovative
projects
that
address
the
requirements
of
the
National
Pollutant
Discharge
Elimination
Systems
(
NPDES)
program
with
special
emphasis
on
wet
weather
activities,
i.
e.,
storm
water,
combined
sewer
overflows,
sanitary
sewer
overflows,
and
concentrated
animal
feeding
operations
as
well
as
projects
that
enhance
the
ability
of
the
regulated
community
to
deal
with
nontraditional
pollution
problems
in
priority
watersheds.
An
organization
whose
IP
is
selected
for
possible
Federal
assistance
must
complete
and
EPA
Application
for
Assistance,
including
the
Federal
SF
424
form
(
Application
for
Federal
Assistance,
see
40
CFR
30.12
and
31.10).
Organizations
who
have
an
existing
agreement
under
this
program
are
eligible
to
compete
with
proposals
for
new
awards.
The
Office
of
Wastewater
Management,
Office
of
Water,
EPA
Headquarters
Has
Identified
the
Following
High
Priority
Areas
for
Consideration
WQCAs
awarded
under
section
104(
b)(
3)
may
only
be
used
to
conduct
and
promote
the
coordination
and
acceleration
of
activities
such
as
research,
investigations,
experiments,
training,
education,
demonstrations,
surveys,
and
studies
relating
to
the
causes,
effect,
extent,
prevention,
reduction,
and
elimination
of
water
pollution.
These
activities,
while
not
defined
in
the
statute,
advance
the
state
of
knowledge,
gather
information,
or
transfer
information.
For
instance,
``
demonstrations''
are
generally
projects
that
demonstrate
new
or
experimental
technologies,
methods,
or
approaches
and
the
results
of
the
project
will
be
disseminated
so
that
others
can
benefit
from
the
knowledge
gained.
A
project
that
is
accomplished
through
the
performance
of
routine,
traditional,
or
established
practices,
or
a
project
that
is
simply
intended
to
carry
out
a
task
rather
than
transfer
information
or
advance
the
state
of
knowledge,
however
worthwhile
the
project
may
be,
is
not
a
demonstration.
Research
projects
may
include
the
application
of
established
practices
when
they
contribute
to
learning
about
an
environmental
concept
or
problem.
The
Office
of
Wastewater
Management
at
EPA
Headquarters
has
identified
several
subject
areas
for
priority
consideration.
EPA
will
award
WQCAs
for
research,
investigations,
experiments,
training,
demonstrations,
surveys
and
studies
related
to
the
causes,
effects,
extent,
prevention,
reduction,
and
elimination
of
water
pollution
in
the
following
subject
areas:
Impacts
of
Wet
Weather
Flows
Trends
in
load
reduction
due
to
implementation
of
storm
water
Best
Management
Practices
(
BMPs)
including
means
of
measuring
effectiveness
of
BMPs
Storm
water
monitoring
techniques
Efficient
and
effective
reduction
of
Sanitary
Sewer
Overflows
(
SSO)
Impacts
of
sewage
overflows
Impacts
of
peak
wet
weather
flows
on
Publicly
Owned
Treatment
Works
(
POTW)
Environmental
effectiveness
of
sewer
separation
Compliance
with
Storm
Water
Phase
II
National
Pollutant
Discharge
Elimination
System
(
NPDES)
Program
Strategies
To
Implement
Watershed
Based
Efforts
Watershed
Integration
of
Water
Programs
under
CWA
&
Safe
Drinking
Water
Act
(
SDWA)
Alternative
markets
or
treatments
for
excess
manure
Nutrient
loading
reduction
through
trading
VerDate
0ct<
09>
2002
14:
59
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30,
2002
Jkt
200001
PO
00000
Frm
00016
Fmt
4703
Sfmt
4703
E:\
FR\
FM\
31OCN1.
SGM
31OCN1
| epa | 2024-06-07T20:31:43.237048 | regulations | {
"license": "Public Domain",
"url": "https://downloads.regulations.gov/EPA-HQ-OPP-2002-0218-0001/content.txt"
} |
EPA-HQ-OPP-2002-0218-0002 | Supporting & Related Material | "2002-10-21T04:00:00" | null | 1
of
14
Fax
on
Demand
Telephone:
202
564
3119
Item:
6094
SUPPORTING
STATEMENT
FOR
AN
INFORMATION
COLLECTION
REQUEST
(ICR)
1.
Identification
of
the
Information
Collection
1(
a).
Title
of
the
Information
Collection:
Tolerance
Petitions
for
Pesticides
on
Food/
Feed
Crops
and
New
Inert
Ingredients
ICR
Nos.:
OMB
Control
No.
2070
0024;
EPA
ICR
No.
0597.
08
1(
b).
Short
Characterization/
Abstract
The
use
of
pesticides
to
increase
crop
production
often
results
in
pesticide
residues
in
or
on
the
crop.
To
protect
the
public
health
from
unsafe
pesticide
residues,
the
Environmental
Protection
Agency
(EPA)
sets
limits
on
the
nature
and
level
of
residues
permitted
pursuant
to
section
408
of
the
Federal
Food,
Drug
and
Cosmetic
Act
(FFDCA).
A
pesticide
may
not
be
used
on
food
or
feed
crops
unless
the
Agency
has
established
a
tolerance
(maximum
residue
limit)
for
the
pesticide
residues
on
that
crop,
or
established
an
exemption
from
the
requirement
to
have
a
tolerance.
It
is
EPA's
responsibility
to
ensure
that
the
maximum
residue
levels
likely
to
be
found
in
or
on
food/
feed
are
safe
for
human
consumption
through
a
careful
review
and
evaluation
of
residue
chemistry
and
toxicology
data.
In
addition
it
must
ensure
that
adequate
enforcement
of
the
tolerance
can
be
achieved
through
the
testing
of
submitted
analytical
methods.
Once
the
data
are
deemed
adequate
to
support
the
findings,
EPA
will
establish
the
tolerance
or
grant
an
exemption
from
the
requirement
of
a
tolerance.
There
are
basically
three
types
of
tolerance
actions:
(1).
Permanent
tolerance
(or
an
exemption
from
the
requirement
for
a
permanent
tolerance)
for
residues
which
would
result
from
a
pesticide
use
registered
under
FIFRA.
These
tolerances
can
be
established
for
raw
and
processed
foods
and
they
can
address
both
active
and
inert
ingredients
in
pesticides.
The
vast
majority
of
these
actions
are
taken
in
response
to
petitions,
but
the
Agency
may
also
initiate
such
actions.
As
indicated
previously,
this
ICR
only
applies
to
the
information
collection
activities
associated
with
tolerance
petitions,
not
Agency
initiated
actions.
2
of
14
(2).
Temporary
tolerance
(or
an
exemption
from
the
requirement
for
a
temporary
tolerance)
to
permit
the
sale
of
commodities
containing
residues
resulting
from
authorized
experimental
use
of
an
unregistered
pesticide.
In
the
absence
of
such
a
tolerance
or
exemption,
all
such
commodities
must
be
destroyed.
In
submitting
an
application
for
Experimental
Use
Permit
(EUP),
the
applicant
may
also
request
that
the
Agency
establish
a
tolerance
or
an
exemption
from
the
tolerance
requirement.
This
ICR
does
not
cover
EUP
related
tolerance
information
collection
activities,
which
are
covered
by
the
ICR
entitled,
"Application
for
Experimental
Use
Permit
(EUP)
to
Ship
and
Use
a
Pesticide
for
Experimental
Purposes
Only"
(OMB
Control
#2070
0040,
EPA
ICR
#276).
(3).
Time
limited
tolerance
(or
an
exemption
from
the
requirement
for
a
time
limited
tolerance)
to
permit
the
sale
of
commodities
containing
residues
resulting
from
a
pesticide
whose
use
was
authorized
under
FIFRA
§18.
Under
FIFRA
§18,
EPA
may
allow
States
to
use
a
pesticide
for
an
unregistered
use
for
a
limited
time
if
EPA
determines
that
emergency
conditions
exist.
FQPA
requires
EPA
to
establish
tolerances
to
cover
all
pesticide
residues
in
food,
even
residues
resulting
from
emergency
uses.
Although
the
Agency
initiates
these
tolerance
actions,
these
actions
are
taken
in
response
to
petitions
for
the
Agency
to
issue
an
action
under
FIFRA
§18.
This
ICR
does
not
cover
information
collection
related
to
FIFRA
§18
tolerance
activities,
which
is
collected
under
the
ICR
entitled,
"Application
and
Summary
for
an
Emergency
Exemption
for
Pesticides"(
OMB
Control
#2070
0032,
EPA
ICR
#596).
This
ICR
only
applies
to
the
information
collection
activities
associated
with
the
submission
of
a
petition
for
a
tolerance
action.
There
are
no
forms
associated
with
this
information
collection.
While
EPA
is
authorized
to
set
pesticide
tolerances,
the
Food
and
Drug
Administration
(FDA)
is
responsible
for
their
enforcement.
Food
or
feed
commodities
found
to
contain
pesticide
residues
in
excess
of
established
tolerances
are
considered
adulterated,
and
are
subject
to
seizure
by
FDA,
and
may
result
in
civil
penalties.
2.
Need
For
and
Use
of
the
Collection
2(
a).
Need/
Authority
for
the
Collection
The
tolerances
for
pesticide
residues
in
food
or
feed
are
set
primarily
under
the
authority
of
section
408
of
the
Federal
Food,
Drug
and
Cosmetic
Act
(FFDCA),
as
amended.
The
Agency
takes
these
tolerance
actions
either
on
its
own
initiative
pursuant
to
FFDCA
§408(
e)
or
in
response
to
a
petition
filed
pursuant
to
FFDCA
§408(
d).
The
regulations
covering
tolerances
are
contained
in
Title
40
of
the
Code
of
Federal
Regulations
(CFR)
Parts
177
and
180.
Actual
listings
of
individual
tolerances
by
chemical
are
found
in
Parts
180,
185
and
186.
3
of
14
Under
FFDCA
§408(
d),
any
person
may
file
a
petition
with
EPA,
proposing
the
issuance
of
a
regulation
establishing,
modifying,
or
revoking
(a)
a
tolerance
for
a
pesticide
chemical
residue
in
or
on
food,
or
(b)
an
exemption
from
the
requirement
to
have
a
tolerance
for
such
residue.
The
Agency
publishes
a
notice
of
receipt
for
such
petitions
in
order
to
provide
an
opportunity
for
public
comment
on
the
request,
and
then
either
issues
a
final
regulation,
or
a
notice
denying
the
petitioner's
request.
FFDCA
§408(
d)(
4)
directs
the
Agency
to
issue
a
final
regulation
after
considering
the
petitioner's
request.
Under
FFDCA
§408(
e),
at
any
time
the
Agency
may
issue
a
regulation
establishing,
modifying,
suspending,
or
revoking
(a)
a
tolerance
for
a
pesticide
chemical
residue
in
or
on
food,
or
(b)
an
exemption
from
the
requirement
to
have
a
tolerance
for
such
residue.
When
initiating
such
actions,
FFDCA
§408(
e)(
2)
requires
the
Agency
to
issue
a
notice
of
proposed
rulemaking
to
provide
an
opportunity
for
public
comment.
The
Food
Quality
Protection
Act
of
1996
(FQPA),
which
amended
the
two
primary
statutes
regulating
pesticides,
i.
e.,
FFDCA
and
the
Federal
Insecticide,
Fungicide
and
Rodenticide
Act
(FIFRA),
requires
that
tolerances
be
set
at
a
level
to
ensure
that
there
be
"a
reasonable
certainty
that
no
harm
will
result
from
aggregate
exposure."
Among
other
things,
FQPA
requires
EPA
to
consider
a
number
of
new
factors
when
setting
such
tolerances
or
registering
pesticide
products,
including:
1)
special
protection
for
infants
and
children;
2)
aggregate
exposure
and
risk
from
foods
and
other
known
sources,
such
as
drinking
water
and
household
pesticide
use;
3)
consideration
of
common
mechanisms
of
toxicity
(some
chemicals
have
different
molecular
structures
but
cause
deleterious
effects
in
the
same
manner);
and
4)
consideration
of
endocrine
disruptor
effects.
The
collection
of
information
covered
by
this
ICR
is
needed
to
ensure
that
the
statutory
requirements
related
to
tolerances
can
be
met
by
the
public
and
EPA.
Food
or
feed
commodities
found
to
contain
residues
of
a
pesticide
without
or
in
excess
of
established
tolerances
are
considered
adulterated,
and
are
subject
to
seizure
by
FDA,
and
may
result
in
civil
penalties.
2(
b).
Practical
Utility/
Users
of
the
Data
The
FQPA
directs
the
Agency
to
consider
aggregate
exposures
from
dietary
and
nonoccupational
sources
when
assessing
the
risks
of
a
chemical
and
setting
tolerances.
In
addition
to
dietary
exposure,
such
sources
as
drinking
water
and
residential
lawn
care
use
need
to
be
considered.
EPA
must
make
the
statutory
determination
that
the
resulting
pesticide
residues
in
food
or
feed
will
result
in
a
reasonable
certainty
of
no
harm
effects
of
human
health
from
aggregate
exposure
through
dietary,
non
occupational,
and
drinking
water
routes
of
exposure
before
establishing
the
tolerance.
4
of
14
EPA
uses
the
data
collected
to
set
the
tolerance.
The
Agency's
Risk
Managers
review
all
regulatory
aspects
of
each
petition,
coordinate
scientific
review
of
supporting
data,
and
prepare
the
public
notices
and
rules
necessary
to
establish
a
tolerance
or
an
exemption.
The
Agency's
Residue
Chemists
review
the
residue
data
submitted
to
determine
if
the
nature
and
magnitude
of
likely
residues
are
adequately
characterized,
and
ensure
that
acceptable
analytical
methods
are
available
to
enforce
the
tolerance
once
established.
The
Agency's
Toxicologists
review
the
toxicology
data
to
evaluate
the
potential
effects
of
the
residues
on
health,
and
assess
the
cumulative
dietary
significance
of
residues
of
the
pesticide
on
other
crops
and
commodities,
and
the
likelihood
of
exposure
to
particularly
sensitive
sub
populations.
As
a
result
of
these
reviews,
EPA
is
able
to
make
the
statutory
determination
that
the
resulting
pesticide
residues
in
food
or
feed
will
not
cause
unreasonable
adverse
dietary
effects
on
human
health.
3.
Non
Duplication,
Consultations,
and
Other
Collection
Criteria
3(
a).
Non
duplication
To
avoid
potential
overlap
between
the
requirement
of
developing
data
in
support
of
a
tolerance
petition
and
the
development
of
data
for
a
FIFRA
registration,
EPA
allows
the
use
of
data
required
to
support
a
tolerance
petition
that
are
already
archived
in
EPA
records
for
use
as
partofa
FIFRAregistrationofa
pesticidetobeusedina
like
mannerandinthe
same
usepattern.
3(
c).
Consultations
In
order
to
reduce
the
petition
processing
time,
pre
filing
conferences
may
be
conducted
to
identify
and
resolve
possible
problem
issues
on
petitions.
However
once
a
petition
is
filed,
consultation
and/
or
dialogue
between
the
petitioner
and
the
EPA
occurs
on
an
informal,
ongoing
"as
needed"
basis.
Most
dialog
occurs
at
the
time
of
a
re
submission
to
correct
a
deficiency
and
the
subsequent
review
of
the
petition
data.
Our
experience
has
been
that
when
any
sort
of
a
problem
arises,
whether
it
is
technical,
administrative,
or
of
any
other
nature,
the
participants
have
ample
opportunity
and
do
not
hesitate
to
contact
the
Agency.
The
respondent
burden
reflected
in
this
ICR
is
for
petition
requests
for
new
tolerance
actions.
Currently
the
bulk
of
tolerance
reassessment
activities
are
conducted
through
the
Reregistration
program,
and
as
a
result,
the
respondent
burden
associated
with
the
new
FQPA
standards
for
tolerance
reassessment
activities
have
been
estimated
as
part
of
the
Data
Generation
for
Pesticide
Reregistration
ICR
(OMB
No.
2070
0107;
EPA
ICR
No.
1504),
and
are
not
included
in
this
ICR.
This
ICR
estimates
that
an
average
of
150
tolerance
petitions
will
be
submitted
to
the
Agency
each
year.
The
estimate
has
not
changed
from
the
previous
ICR
and
is
based
on
the
number
of
petitions
received
for
fiscal
years
1999,
2000,
and
2001.
It
is
important
to
note
that
these
numbers
represent
the
number
of
petitions
that
were
received,
not
the
number
of
tolerance
5
of
14
actions
that
were
requested.
Since
1995,
the
Agency
has
allowed
for
the
use
of
a
single
petition
to
request
a
tolerance
action(
s)
for
a
group
of
similar
crops,
or
"Crop
Groupings,"
rather
than
submitting
individual
petitions
on
a
crop
by
crop
basis.
In
reviewing
some
of
the
petitions,
it
is
apparent
that
many
petitioners
take
advantage
of
this
flexibility,
including
in
the
petition
requests
for
several
tolerance
actions.
Some
have
sought
as
many
as
15
individual
tolerance
actions
in
a
single
petition.
In
addition,
the
FQPA
amendments
now
allow
anyone
to
submit
a
petition,
where
previously
only
registrants
could
submit
the
petition.
3(
d).
Effects
of
Less
Frequent
Collection
Not
applicable.
This
activity
is
conducted
only
once
per
"event,"
so
a
less
frequent
collection
is
not
possible.
3(
e).
General
Guidelines
Due
to
the
statutory
mandate
for
the
permanent
retention
of
supporting
chemistry
and
toxicological
data
related
to
pesticides,
the
data
included
in
petitions
must
be
maintained
for
the
life
of
the
pesticide.
This
mandate
exceeds
the
PRA
guideline
that
records
be
retained
for
no
more
than
three
years.
3(
f).
Confidentiality
Trade
secret
or
confidential
business
information
(CBI)
is
frequently
submitted
to
the
EPA
in
this
program
because
submissions
usually
include
the
manufacturing
process,
product
formulation,
and
supporting
data.
When
such
information
is
provided
to
the
Agency,
the
information
is
protected
from
disclosure
under
FIFRA
Section
10.
CBI
data
submitted
to
the
EPA
is
handled
strictly
in
accordance
with
the
provisions
of
the
FIFRA
Confidential
Business
Information
Security
Manual.
3(
g).
Sensitive
Questions
Not
applicable.
No
information
of
a
sensitive
or
private
nature
is
requested
in
this
information
collection
activity.
4.
The
Respondents
and
the
Information
Requested
4(
a).
Respondents/
NAICS
Codes
Respondents
to
this
information
collection
activity
include
anyone
who
files
a
petition
asking
the
Agency
to
take
a
specific
tolerance
action.
Although
such
petitions
typically
come
from
those
businesses
engaged
in
the
manufacturing
of
pesticides,
the
Agency
may
also
receive
6
of
14
petitions
from
other
entities,
including
the
Interregional
Research
Project
No.
4
(IR
4),
third
party
registrants,
grower
groups,
importers
or
other
governments,
and
concerned
citizens.
Although
it
is
impossible
to
identify
all
the
North
American
Industrial
Classification
System
(NAICS)
codes
for
all
of
the
potential
respondents,
the
NAICS
code
assigned
to
this
program
is
325320
(Pesticide
and
other
Agricultural
Chemical
Manufacturing).
4(
b).
Information
Requested
(i)
Data
Items,
Including
Record
Keeping
Requirements
In
addition
to
a
cover
letter
and
fee,
a
tolerance
petition
must
include
the
following
nine
parts:
Chemical
identity
The
name,
chemical
identity,
and
composition
of
the
pesticide
chemical.
If
the
pesticide
chemical
is
an
ingredient
of
a
pesticide,
the
complete
quantitative
formula
of
the
resulting
pesticide
product
should
be
submitted.
The
submission
of
this
information
does
not
restrict
the
application
of
any
tolerance
or
exemption
granted
to
the
specific
formula(
s)
submitted.
Chemical
use
The
amount,
frequency,
and
time
of
application
of
the
pesticide
chemical.
Safety
reports
Include
reports
of
investigations
made
with
respect
to
the
safety
of
the
pesticide
chemical.
These
reports
should
include,
when
necessary,
detailed
data
derived
from
appropriate
animal
or
other
biological
experiments
in
which
the
methods
used
and
the
results
obtained
are
clearly
set
forth.
Residue
test
results
The
results
of
tests
on
the
amount
of
residue
remaining,
including
description
of
the
analytical
method
used.
(See
40
CFR
180.34
for
further
information
about
residue
tests.)
Residue
removal
Practicable
methods
for
removing
residue
that
exceeds
any
proposed
tolerance.
Proposed
tolerance
Proposed
tolerances
for
the
pesticidal
chemical
if
specific
tolerances
are
being
proposed.
Grounds
for
petition
Reasonable
grounds
in
support
of
the
petition.
7
of
14
Supplemental
information
Analysis
of
factors
relevant
to
the
provisions
of
FQPA,
specifically,
aggregate
exposure,
children's
exposure,
special
sensitivities,
cumulative
effects
and
endocrine
disruptor
effects.
Summary
An
informative
summary
of
the
petition
or
application,
including
a
summary
of
the
supporting
data,
information,
accompanying
rationales,
and
a
statement
providing
permission
to
publish
such
summary.
This
summary
should
indicate
how
approval
of
the
petition
will
meet
the
statutory
determination
required
of
"reasonable
certainty
of
no
harm."
The
data
compiled
should
be
submitted
as
separate
sections,
suitably
identified.
If
data
has
already
been
submitted
with
an
earlier
application,
the
present
petition
may
incorporate
it
by
reference.
The
petition
must
be
submitted
in
triplicate.
The
petitioner
must
also
show
that
the
pesticide
is
already
registered
for
the
related
food
or
feed
use,
or
that
an
application
for
the
registration
of
a
pesticide
for
the
related
food
or
feed
use
has
been
submitted
pursuant
to
section
3
ofFIFRA.
(ii)
Respondent
Activities
In
order
for
a
tolerance
to
be
established
for
a
pesticide
product,
a
respondent
(petitioner)
must
do
the
following:
Review
regulations
Read
applicable
FFDCA
provisions
and
related
tolerance
regulations;
Conduct
tests
conduct
any
toxicological
or
residue
chemistry
studies
and
develop
analytical
methods
required
in
order
to
provide
the
EPA
with
the
data
necessary
to
make
a
decision
to
accept
or
reject
a
tolerance
petition
and
review
the
requested
data
for
accuracy/
appropriateness;
Prepare
correspondence
generate
petition
correspondence,
including
preparing
a
informative
summary
to
be
published
in
the
Federal
Register;
Review
Agency
comment
if
applicable,
read
any
Agency
notice
of
petition
deficiency;
Respond
to
Agency
comment
submit
supplemental
information
or
petition,
or
request
that
petition
be
filed
as
submitted;
and
Maintain
records
store,
file
and
maintain
the
information
submitted.
8
of
14
Changes
as
a
Result
of
the
Passage
of
the
FQPA
EPA
is
applying
the
new
FQPA
standard
to
all
tolerances
for
newly
registered
chemicals
and
food
uses.
In
addition,
FQPA
has
set
a
schedule
for
reassessing
all
10,000
existing
tolerances
under
this
new
standard
by
2006.
The
new
law
did
not
provide
for
a
phase
in
period
for
many
of
the
new
requirements
which
had
not
previously
been
a
part
of
EPA's
risk
assessment
process.
Although
EPA
does
not
require
registrants
to
submit
any
additional
information
under
this
ICR,
the
new
FQPA
provisions
requires
EPA
to
consider
additional
information
in
order
to
make
the
necessary
regulatory
decisions.
Petitioners
who
submitted
data
to
the
Agency
prior
to
passage
of
FQPA
were
therefore
encouraged
to
supplement
their
original
submissions
with
additional
information.
Respondents
submitting
new
petitions
may
want
to
submit
supplemental
information.
Section
408
of
FFDCA
requires
petitioners
submit
"an
information
summary
of
the
petition
and
of
the
data,
information
and
arguments
submitted
or
cited
in
support
of
the
petition."
To
allow
for
the
most
efficient
processing
and
review
of
tolerance
petitions,
the
Agency
has
provided
a
description
of
the
types
of
information
that
EPA
considers
helpful
in
the
appendices
to
Pesticide
Registration
(PR)
Notice
No.
97
1,
Attachment
PR
Notice
97
1
applies
to
most
applicants
with
registration
applications,
non
cropdestruct
experimental
use
permit
applications,
and
tolerance
or
tolerance
exemption
petitions
pending
within
the
Agency.
It
also
applies
to
most
future
applicants
seeking
new
or
amended
pesticide
registrations
and
all
actions
involving
synthetic
chemicals,
antimicrobial,
biochemical
and
microbial
pesticides.
However,
the
notice
does
not
apply
to
applicants
seeking
fast
track
metoo
registrations
or
amendments
not
involving
new
uses.
5.
The
Information
Collected
Agency
Activities,
Collection
Methodology,
and
Information
Management
5(
a)
Agency
Activities
Upon
receipt
of
a
tolerance
petition,
EPA
performs
the
following
activities:
Log
Receipt
Log
petition
and
associated
fee.
Review
petition
Screen
petition,
fee,
and
supporting
data
for
completeness
and
acceptability;
resolve
any
deficiencies
with
petitioner.
Prepare
Federal
Register
notice
Upon
acceptance,
publish
notice
of
filing
in
Federal
Register.
Review
data
Review
supporting
residue
chemistry,
toxicology
data
and
other
assessments
received.
9
of
14
Test
analytical
methods
Test
proposed
analytical
methods
in
EPA
laboratories,
if
they
are
new
or
modified.
Integrate
review
Integrate
data
reviews
and
determine
adequacy;
resolve
any
deficiencies
with
petitioner,
make
registration
decision.
Prepare
decision
document
Prepare
decision
document,
Federal
Register
Notice
with
rule
establishing
the
tolerance(
s)
or
exemption(
s).
Maintain
records
Record
all
actions
and
decisions
in
official
records.
5(
b).
Collection
Methodology
and
Management
Specific
studies
submitted
as
part
of
petition
are
catalogued
and
archived
as
they
are
received.
When
the
Agency
review
is
complete,
the
remaining
portions
of
the
petition
record,
including
correspondence
subsequent
to
filing
and
all
reviews,
notices,
and
other
materials
created
by
EPA
in
the
course
of
its
review,
are
catalogued
and
archived.
All
petition
materials
are
retained
permanently.
5(
c).
Small
Entity
Flexibility
At
times,
small
entities
seek
a
tolerance
or
an
exemption
from
the
requirement
of
a
tolerance
for
pesticide
residues
resulting
from
registered
uses.
These
actions
are
usually
initiated
for
minor
crop
uses
for
which
the
pesticide
registrant
is
unwilling
to
seek
a
tolerance
or
for
residues
on
commodities
which
are
not
grown
in
the
United
States
and
therefore
for
which
there
is
no
U.
S.
registrant,
such
as
import
tolerances.
In
such
cases,
the
EPA
can
reduce
the
burden
and
cost
to
small
entities
by
adjusting
the
range
of
data
requirements
to
be
commensurate
with
the
extent
of
pesticide
use.
The
Agency
also
uses
this
type
of
regulatory
flexibility
to
set
tolerances
for
residues
on
commodities
which
are
not
grown
in
the
United
States.
5(
d).
Collection
Schedule
Not
applicable.
This
is
not
a
scheduled
collection.
A
petition
is
required
only
once
for
each
raw
or
processed
commodity
on
which
the
pesticide
is
used.
6.
Estimating
the
Burden
and
Cost
of
the
Collection
6(
a).
Estimating
Respondent
Burden
1
This
estimate
was
derived
from
a
survey
prepared
by
EPA's
Office
of
Pesticide
Programs,
Economic
Analysis
Branch,
with
support
from
DPRA,
Inc.,
and
W.
R.
Landis
Associates,
Inc.,
September
28,
1990.
2
Ibid.
10
of
14
The
Agency
projects
that
it
will
receive
between
100
and
150
petitions
on
an
annual
basis
over
the
next
three
years.
This
ICR
projects
the
respondent
burden
estimates
based
on
150
petitions
annually.
Therefore,
the
burden
estimates
that
registrants
may
spend
approximately
258,900
hours
or
$23,435,700
per
year
to
comply
with
all
of
the
requirements
for
petitions.
Two
types
of
burden
on
respondents
are
considered
in
this
analysis:
administrative
burden
and
technical
burden.
The
respondents'
administrative
burden
is
defined
as
the
time
spent
to
prepare
and
submit
a
petition
to
the
Agency.
It
includes
the
time
spent
working
with
the
Agency
throughout
the
petition
process,
gathering
the
required
data
(such
as
the
safety
reports,
residue
test
data,
residue
removal
data),
gathering
supplemental
information,
drafting
the
grounds
for
the
petition,
reviewing
and
submitting
the
petition.
The
technical
burden
includes
the
labor
needed
to
actually
derive
the
test
data
which
involves
designing
the
test,
performing
it,
compiling
test
data
and
summarizing
the
results.
For
the
purposes
of
calculating
paperwork
burden,
only
the
technical
burden
related
to
the
documentation
of
the
test
results,
complying
with
good
laboratory
standards
in
conducting
the
tests,
and
storing
testing
information
in
files
are
included
in
the
burden
estimates
for
this
ICR.
To
quantify
the
administrative
burden,
the
Agency
estimated
the
amount
of
labor
as
a
percentage
of
the
total
test
costs.
The
Agency
assumed
that
respondents
would
expend
approximately
two
percent
of
the
total
test
cost
for
administrative
paperwork
burden.
This
percentage
represents
an
estimate
obtained
from
expert
opinion,
industry
sources,
and
proprietary
data.
The
Agency
assumed
that
the
value
of
this
time
is
equally
divided
among
management
and
technical
staff
members.
The
methodology
for
calculating
the
technical
burden
differs
from
the
administrative
burden.
One
third
of
the
total
test
cost
represents
labor.
1
Management,
technical
and
clerical
comprise
the
labor
staff.
A
proportional
labor
rate
is
used
to
calculate
the
number
of
hours.
Approximately
70
percent
is
technical,
20
percent
management,
and
10
percent
clerical.
2
The
paperwork
burden
is
a
portion
of
the
total
annual
labor
burden
estimated
at
1,
726
hours
per
year
per
petition.
The
total
estimated
respondent
paperwork
burden
to
comply
with
this
information
collection
activity
is
258,900
hours
per
year
based
on
the
estimated
submission
of
150
petitions
each
year.
11
of
14
Table
1–
ANNUAL
RESPONDENT
BURDEN/
COST
ESTIMATES
ACTIVITIES
BURDEN
HOURS
(per
year)
COSTS
(per
year)
Mgmt.
$130/
hr
Tech.
$88/
hr
Cler.
$40/
hr
Total
Hours
Total
Costs
a)
Review
FFDCA
regulations
CFR
citation;
PRN
97
1
25
48
24
97
$8,434
b)
Conduct
Field
Trial
252
1,080
25
1,357
$128,800
c)
Prepare
Petition
42
30
116
188
$12,740
d)
Read
Notice
of
any
petition
deficiency
1
1
1
3
$258
e)
Prepare
response
2
44
12
58
$4,612
f)
Maintain
information
1
8
14
23
$1,
394
TOTAL
BURDEN
323
1,211
192
1,726
$156,238
ANNUAL
BURDEN:
1,726
total
hours
x
150
petitioners
258,900
hours
6(
b).
Estimating
Respondent
Costs
The
total
annual
cost
to
respondents
(projected
at
150)
petitioning
for
tolerances
for
pesticides
on
food/
feed
crops
and/
or
for
new
inert
ingredients
is
estimated
at
$33,803,700.
For
respondents,
the
value
of
labor
per
hour
for
management,
technical,
and
clerical
is
$130,
$88,
and
$40,
respectively.
Respondent
labor
rates
are
based
on
the
Gross
Domestic
Product
as
calculated
by
the
US
Department
of
Commerce's
Bureau
of
Economic
Analysis,
which
reflect
more
accurately
the
costs
borne
by
the
parties
who
petition
the
Agency
for
various
types
of
tolerance
actions.
Estimates
for
respondent
burden
are
provided
below.
ANNUAL
COSTS:
(a)
Management
323
hours
x
$130
x
150
applicants
$
6,
298,500
(b)
Technical
1211
hours
x
$
88
x
150
applicants
$15,985,200
(c)
Clerical
192
hours
x
$
40
x
150
applicants
$
1,
152,000
TOTAL
$23,435,700
These
labor
burden
estimates
represent
the
average
time
and
costs.
Some
tolerance
petitions
will
require
less
effort
and
more
complicated
petitions
will
require
more
of
each.
The
analysis
assumes
that
one
respondent
will
generate
the
data
for
a
given
petition.
If
a
consortium
12
of
14
takes
responsibility
for
the
petition,
the
burden
and
cost
will
be
distributed
across
members
of
the
consortium.
6(
c).
Estimating
Agency
Burden
and
Cost
The
Agency
needs
to
process,
review
and
document
their
evaluation
of
the
tolerance
petitions.
Each
year,
the
Agency
may
spend
345,000
hours
for
150
petitions
in
labor
burden.
Agency
labor
rates
are
based
on
Office
of
Personnel
Management
salary
tables
for
federal
employees
for
the
years
1999
through
2001
and
include
benefits
and
overhead
costs,
as
well
as
locality
pay
for
the
Washington,
DC
Baltimore
area.
Estimates
for
the
Agency's
burden
are
provided
below.
Table
2
–
ANNUAL
AGENCY
BURDEN/
COST
ESTIMATES
COLLECTION
ACTIVITIES
BURDEN
HOURS
(per
year)
COSTS
(per
year)
Mgmt.
$96/
hr.
Tech.
$70/
hr
Cler.
$33/
hr
Total
Hours
Total
Costs
a)
Log
petition
and
associated
fee
0
8
0
8
$560
b)
Screen
petition
request
for
completeness
1
2
0
3
$236
c)
Draft
and
publish
Federal
Register
notice
1
4
0
5
$376
d)
Review
Residue
Chemistry
and
Toxicology
data
200
1,642
3
1845
$134,239
e)
Verify
new
analytical
methods
in
EPA
Lab.
and
resolve
any
deficiencies
34
223
1
258
$18,907
f)
Integrate
Data
Reviews
67
100
2
169
$13,498
g)
Prepare
decision
document
and
Federal
Register
Notice
4
4
2
10
$730
h)
Record
actions
in
official
records.
0
0
2
2
$66
TOTAL
BURDEN
307
1983
10
2300
$168,612
(a)
Management
307
hours
x
$96
x
150
petitioners
$
4,420,800
(b)
Technical
1,
983
hours
x
$70
x
150
petitioners
$
20,821,500
(c)
Clerical
10
hours
x
$33
x
150
petitioners
$
49,500
TOTAL
$
25,291,800
13
of
14
6(
d).
Bottom
Line
Burden
Hours
And
Cost
Tables
Table
3
–
MASTER
TABLE:
Total
Annual
Burden
Hours
and
Costs
Total
Annual
petitions
Annual
Burden
Hours
Annual
Costs
per
petition
Total
per
petition
Total
Respondents
(Petitioners)
150
1726
258,900
$147,538
$23,435,700
Agency
150
2300
345,000
$147,001
$25,291,800
6(
e).
Reasons
for
Change
in
Burden
Respondent
costs
for
this
ICR
have
increased
due
to
increases
in
labor
rates
for
both
respondents
and
Agency
personnel.
As
a
result,
there
is
an
increase
of
$1,305,000
in
the
estimated
total
annual
respondent
cost
(from
$22,130,700
to
$23,435,700).
This
change
is
an
adjustment.
Although
petitions
may
now
be
submitted
by
anyone,
the
Agency
has
not
changed
the
estimated
total
annual
number
of
petitions
expected
to
be
submitted.
Although,
as
explained
in
section
5(
b)
of
this
ICR,
the
annual
average
number
of
petition
received
between
1999
and
2001
is
100
petitions,
the
Agency
has
chosen
to
continue
to
use
the
annual
estimate
of
150
petitions
for
estimating
the
total
burden
in
this
ICR.
Since
the
number
of
petitions
received
fluctuates
from
year
to
year,
the
Agency
believes
that
using
this
higher
estimate
will
ensure
that
the
annual
burden
approved
under
this
ICR
is
sufficient
to
cover
the
burden
in
a
year
in
which
more
than
the
average
number
of
petitions
are
received.
6(
f).
Burden
Statement
The
total
estimated
annual
respondent
paperwork
burden
to
comply
with
this
information
collection
activity
is
258,900
hours.
According
to
the
Paperwork
Reduction
Act,
"burden"
means
the
total
time,
effort,
or
financial
resources
expended
by
persons
to
generate,
maintain,
retain,
or
disclose
or
provide
information
to
or
for
a
Federal
agency.
For
this
collection,
it
is
the
time
reading
the
regulations,
planning
the
necessary
data
collection
activities,
conducting
tests,
analyzing
data,
generating
reports
and
completing
other
required
paperwork,
and
storing,
filing,
and
maintaining
the
data.
The
agency
may
not
conduct
or
sponsor,
and
a
person
is
not
required
to
respond
to,
a
collection
of
information
unless
it
displays
a
currently
valid
OMB
control
number.
The
OMB
control
number
for
this
information
collection
appear
at
the
beginning
and
the
end
of
this
document.
In
addition
OMB
control
numbers
for
EPA's
regulations,
after
initial
display
in
the
final
rule,
are
listed
in
40
CFR
part
9.
14
of
14
Send
comments
regarding
burden
estimate
or
any
other
aspect
of
this
collection
of
information,
including
suggestions
for
reducing
the
burden
to:
Director,
Collection
Strategies
Division,
U.
S.
Environmental
Protection
Agency
(2822),
1200
Pennsylvania
Avenue,
NW,
Washington,
D.
C.
20460.
Include
the
OMB
control
number
in
any
correspondence,
but
do
not
submit
the
requested
information
or
forms
to
this
address.
The
requested
information
should
be
submitted
in
accordance
with
the
instructions
in
the
Federal
Register
Notice
seeking
comment
on
this
ICR.
Please
reference
this
document
by
the
OMB
Control
No.
2070
0024
in
all
correspondence.
| epa | 2024-06-07T20:31:43.243083 | regulations | {
"license": "Public Domain",
"url": "https://downloads.regulations.gov/EPA-HQ-OPP-2002-0218-0002/content.txt"
} |
EPA-HQ-OPP-2002-0219-0001 | Notice | "2002-09-20T04:00:00" | Methoxyfenozide; Pesticide Tolerance. | 59193
Federal
Register
/
Vol.
67,
No.
183
/
Friday,
September
20,
2002
/
Rules
and
Regulations
commodities
to
the
table
in
paragraph
(
a)(
2).
ii.
The
text
of
paragraph
(
b)
is
removed
and
reserved.
§
180.479
Halosulfuron
methyl;
tolerances
for
residues.
(
a)
General.
*
*
*
(
2)
*
*
*
Commodity
Parts
per
million
*
*
*
*
*
Asparagus
.............................
0.8
Bean,
dry,
seed
....................
0.05
Bean,
snap,
succulent
..........
0.05
*
*
*
*
*
Vegetables,
fruiting
(
except
cucurbits),
group
...............
0.05
(
b)
Section
18
emergency
exemptions.
[
Reserved]
*
*
*
*
*
[
FR
Doc.
02
23995
Filed
9
19
02;
8:
45
am]
BILLING
CODE
6560
50
S
ENVIRONMENTAL
PROTECTION
AGENCY
40
CFR
Part
180
[
OPP
2002
0219;
FRL
7198
5]
Methoxyfenozide;
Pesticide
Tolerance
AGENCY:
Environmental
Protection
Agency
(
EPA).
ACTION:
Final
rule.
SUMMARY:
This
regulation
establishes
tolerances
for
residues
of
methoxyfenozide
and
the
combined
residues
of
methoxyfenozide
and
its
glucuronide
metabolite
on
various
agriculural
food
commodities.
This
regulation
also
establishes
tolerances
for
indirect
or
inadvertent
residues
for
methoxyfenozide
and
establishes
tolerances
for
indirect
or
inadvertent
combined
residues
for
methoxyfenozide
and
its
metabolites
on
various
food
commodities,
and
increases
the
already
established
tolerances
for
residues
of
methoxyfenozide
and
increases
the
already
established
tolerances
for
the
combined
residues
of
methoxyfenozide
and
its
glucuronide
metabolite
on
various
food
commodities.
Rohm
and
Haas
Company
and
the
Interregional
Research
Project
Number
4
(
IR
4),
Technology
Center
of
New
Jersey,
the
State
University
of
New
Jersey
requested
these
tolerances
under
the
Federal
Food,
Drug,
and
Cosmetic
Act,
as
amended
by
the
Food
Quality
Protection
Act
of
1996.
The
chemical
was
subsequently
purchased
by
Dow
Agrosciences
from
Rohm
and
Haas
Company.
The
specific
food
commodities
affected
by
the
establishment
or
increase
of
these
tolerances
are
set
forth
in
the
preamble
to
this
document.
DATES:
This
regulation
is
effective
September
20,
2002.
Objections
and
requests
for
hearings,
identified
by
docket
ID
number
OPP
2002
0219,
must
be
received
on
or
before
November
19,
2002.
ADDRESSES:
Written
objections
and
hearing
requests
may
be
submitted
by
mail,
in
person,
or
by
courier.
Please
follow
the
detailed
instructions
for
each
method
as
provided
in
Unit
VI.
of
the
SUPPLEMENTARY
INFORMATION.
To
ensure
proper
receipt
by
EPA,
your
objections
and
hearing
requests
must
identify
docket
ID
number
OPP
2002
0219
in
the
subject
line
on
the
first
page
of
your
response.
FOR
FURTHER
INFORMATION
CONTACT:
By
mail:
Joseph
M.
Tavano,
Registration
Division
7505C,
Office
of
Pesticide
Programs,
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460;
telephone
number:
(
703)
305
6411;
e
mail
address:
tavano.
joseph@
epa.
gov.
SUPPLEMENTARY
INFORMATION:
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:
Categories
NAICS
Examples
of
Potentially
Affected
Entities
Industry
111
Crop
production
112
Animal
production
311
Food
manufacturing
32532
Pesticide
manufacturing
This
listing
is
not
intended
to
be
exhaustive,
but
rather
provides
a
guide
for
readers
regarding
entities
likely
to
be
affected
by
this
action.
Other
types
of
entities
not
listed
in
the
table
could
also
be
affected.
The
North
American
Industrial
Classification
System
(
NAICS)
codes
have
been
provided
to
assist
you
and
others
in
determining
whether
or
not
this
action
might
apply
to
certain
entities.
If
you
have
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
Additional
Information,
Including
Copies
of
this
Document
and
Other
Related
Documents?
1.
Electronically.
You
may
obtain
electronic
copies
of
this
document,
and
certain
other
related
documents
that
might
be
available
electronically,
from
the
EPA
Internet
home
page
at
http://
www.
epa.
gov/.
To
access
this
document,
on
the
home
page
select
``
Laws
and
Regulations'',
``
Regulations
and
Proposed
Rules,''
and
then
look
up
the
entry
for
this
document
under
the
``
Federal
Register
Environmental
Documents.''
You
can
also
go
directly
to
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.
2.
In
person.
The
Agency
has
established
an
official
record
for
this
action
under
docket
ID
number
OPP
2002
0219.
The
official
record
consists
of
the
documents
specifically
referenced
in
this
action,
and
other
information
related
to
this
action,
including
any
information
claimed
as
Confidential
Business
Information
(
CBI).
This
official
record
includes
the
documents
that
are
physically
located
in
the
docket,
as
well
as
the
documents
that
are
referenced
in
those
documents.
The
public
version
of
the
official
record
does
not
include
any
information
claimed
as
CBI.
The
public
version
of
the
official
record,
which
includes
printed,
paper
versions
of
any
electronic
comments
submitted
during
an
applicable
comment
period
is
available
for
inspection
in
the
Public
Information
and
Records
Integrity
Branch
(
PIRIB),
Rm.
119,
Crystal
Mall
#
2,
1921
Jefferson
Davis
Hwy.,
Arlington,
VA,
from
8:
30
a.
m.
to
4
p.
m.,
Monday
through
Friday,
excluding
legal
holidays.
The
PIRIB
telephone
number
is
(
703)
305
5805.
II.
Background
and
Statutory
Findings
In
the
Federal
Registers
of
January
10,
2000,
65
FR
1370
1381;
FRL
6394
6;
March
19,
2001,
66
FR
15432
15459;
FRL
6766
7;
May
23,
2001,
66
FR
28482
28487;
FRL
6782
5
and
August
24,
2001,
66
FR
44629
44634;
FRL
6796
2;
and
August
14,
2002,
67
FR
52996
53001;
FRL
7191
9.
EPA
issued
notices
pursuant
to
section
408
of
the
Federal
Food,
Drug,
and
Cosmetic
Act
(
FFDCA),
21
U.
S.
C.
346a,
as
amended
by
the
Food
Quality
Protection
Act
of
1996
(
FQPA)
(
Public
Law
104
170),
announcing
the
filing
of
a
pesticide
petitions
(
PP
9F6033;
9F6062;
0F6201;
0F6213;
1F
6259;
1F6287;
2E6382
and
VerDate
Sep<
04>
2002
17:
27
Sep
19,
2002
Jkt
197001
PO
00000
Frm
00059
Fmt
4700
Sfmt
4700
E:\
FR\
FM\
20SER1.
SGM
20SER1
59194
Federal
Register
/
Vol.
67,
No.
183
/
Friday,
September
20,
2002
/
Rules
and
Regulations
2E6408)
by
Rohm
and
Haas
Company,
100
Independence
Mall
West,
Philadelphia,
PA
19106
2399
and
the
Interregional
Research
Project
Number
4
(
IR
4),
Technology
Centre
of
New
Jersey,
the
State
University
of
New
Jersey,
681
U.
S.
Highway
#
1
South,
North
Brunswick,
NJ
08902
3390.
These
notices
included
a
summary
of
the
petitions
prepared
by
Rohm
and
Haas
Company,
the
registrant
or
the
Interregional
Research
Project
Number
4
(
IR
4).
There
were
no
comments
received
in
response
to
these
notices
of
filing.
The
petitions
requested
that
40
CFR
180.544
be
amended
by
establishing
tolerances
for
residues
of
the
insecticide
methoxyfenozide
in
or
on
almond,
hulls;
artichoke,
globe;
field
corn
grain;
field
corn
forage;
field
corn
stover
(
fodder);
corn,
oil;
aspirated
grain
fractions;
sweet
corn
(
K
+
CWHR);
sweet
corn
forage;
sweet
corn
stover
(
fodder);
corn
silage;
stone
fruits
crop
group;
prunes;
grapes;
Spanish
lime;
longan;
lychee;
tree
nut
crop
group;
pulasan;
raisins;
rambutan;
fruiting
vegetables
(
except
cucurbits);
crop
subgroup
4A
leafy
green
vegetables;
4B
leaf
petioles;
head
and
stem
Brassica;
crop
subgroup
5B
leafy
Brassica
greens;
at
45.0,
3.0,
0.05,
15.0,
105,
0.2,
1.0,
0.05,
30,
60,
5.0,
5.0,
7.0,
1.0,
2.0,
2.0,
2.0,
0.1,
2.0,
1.5,
2.0,
2.0,
25.0,
10.0,
6.5,
20
parts
per
million
(
ppm)
respectively
and
an
increase
in
the
established
tolerance
for
residues
of
methoxyfenozide
to
0.1
ppm
in
milk
and
an
increase
in
the
established
tolerances
for
residues
of
methoxyfenozide
and
its
glucuronide
metabolite
in
the
fat
of
cattle,
goats,
horses,
hogs
and
sheep;
liver
of
cattle,
goats,
horses,
hogs
and
sheep;
and
meat
byproducts
(
except
liver)
of
cattle,
goats,
horses
hogs
and
sheep
to
0.5,
0.4
and
0.1
ppm
respectively.
These
petitions
also
requested
that
40
CFR
180.544
be
amended
by
establishing
time
limited
tolerances
for
the
indirect
or
inadvertent
residues
of
methoxyfenozide
and
its
metabolites
RH
117,236
free
phenol
of
methoxyfenozide;
3,5
dimethylbenzoic
acid
N
tert
butyl
N'(
3
hydroxy
2
methylbenzoyl)
hydrazide,
RH
151,055
glucose
conjugateof
RH
117,236;
3,5
dimethylbenzoicacid
N
tert
butyl
N
[
3(
b
D
glucopyranosyloxy)
2
methylbenzoyl]
hydrazide
and
RH
152,072
the
malonylglycosyl
conjugate
of
RH
117,236
in
or
on
root
and
tuber
vegetables;
leaves
of
root
and
tuber
vegetables;
bulb
vegetables;
leafy
vegetables
(
except
Brassica);
Brassica
vegetables;
legume
vegetables;
foliage
of
legume
vegetables;
forage,
fodder,
hay,
and
straw
of
cereal
grains;
grass
forage,
fodder
and
hay;
forage,
fodder,
straw
and
hay
of
non
grass
animal
feeds;
and
herbs
and
spices
when
present
therein
as
a
result
of
application
of
methoxyfenozide
to
growing
crops
at
0.05,
0.1,
0.1,
0.2,
0.2,
0.05,
8.0,
7.0,
7.0,
8.0
and
8.0
ppm
respectively.
Based
on
the
residue
data
submitted,
EPA
has
determined
that
the
following
changes
to
the
requested
tolerances
listed
above
are
necessary.
A
higher
tolerance
of
125
ppm
is
required
for
field
corn
stover.
A
higher
tolerance
of
30.0
ppm
is
required
for
vegetable,
leafy
(
except
Brassica),
leafy
greens
subgroup.
A
higher
tolerance
of
25
ppm
is
required
for
vegetable,
leafy
(
except
Brassica),
leaf
petioles
subgroup.
A
higher
tolerance
of
7.0
ppm
is
required
for
vegetables,
leafy,
Brassica
(
cole),
head
and
stem
subgroup.
A
higher
tolerance
of
30.0
ppm
is
required
for
vegetables,
leafy,
Brassica
(
cole),
greens
subgroup.
A
separate
tolerance
of
0.30
is
needed
for
plums
(
fresh
prune).
A
lower
tolerance
of
25.0
ppm
is
required
for
almond
hulls.
A
higher
tolerance
of
2.0
ppm
is
required
for
aspirated
grain
fractions.
No
tolerance
is
required
for
corn
silage
since
residues
in
silage
are
covered
by
the
proposed
tolerance
for
field
corn
forage.
A
tolerance
for
processed
prunes
is
not
needed.
A
lower
tolerance
of
3.0
ppm
is
required
for
stone
fruit
(
except
plum,
fresh
prune).
The
proposed
higher
tolerances
for
hog
commodities
are
not
needed.
A
tolerance
of
0.02
ppm
is
required
for
poultry,
fat
and
0.02
for
poultry,
meat.
A
tolerance
of
0.02
ppm
is
required
for
eggs.
A
tolerance
of
0.10
ppm
is
required
for
poultry,
liver
and
0.02
ppm
for
poultry
meat
byproducts
(
mbyp)
(
except
liver).
Higher
tolerances
for
the
indirect
or
inadvertent
residues
of
methoxyfenozide
in
or
on
vegetable,
bulb,
group;
vegetable,
root
and
tuber,
group
and
vegetable,
root
and
tuber,
leaves,
group
at
0.20,
0.10,
and
0.20
ppm
respectively
are
required.
Tolerances
for
the
indirect
or
inadvertent
residues
of
methoxyfenozide
in
or
on
leafy
and
Brassica
vegetables
are
not
needed
since
direct
tolerances
are
being
established
for
them.
Higher
tolerances
for
the
indirect
or
inadvertent
combined
residues
of
methoxyfenozide
benzoic
acid,
3
methoxy
2
methyl,
2(
3,5
dimethylbenzoyl)
2(
1,1
dimethylethyl)
hydrazide
and
its
metabolites
RH
117,236
free
phenol
of
methoxyfenozide;
3,5
dimethylbenzoic
acid
N
tert
butyl
N'(
3
hydroxy
2
methylbenzoyl)
hydrazide],
RH
151,055
[
glucose
conjugate
of
RH
117,236;
3,5
dimethyl
benzoic
acid
N
tert
butyl
N[
3
(
b
D
glucopyranosyloxy)
2
methylbenzoyl]
hydrazide
and
RH
152,072
the
malonylglycosyl
conjugate
of
RH
117,236
in
or
on
animal
feed,
non
grass
(
forage,
fodder,
straw,
hay),
group;
grain,
cereal,
forage,
fodder,
and
straw,
group;
grass,
forage,
fodder,
and
hay,
group;
herbs
and
spices,
group;
vegetable,
legume,
group;
and
vegetable,
legume,
foliage,
group
at
10.0
ppm,
10.0
ppm,
10.0
ppm,
10.0
ppm,
0.10
ppm
and
10.0
ppm
respectively
are
needed.
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)
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)
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
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),
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),
for
tolerances
for
residues
of
the
insecticide
methoxyfenozide
in
or
on
almond,
hulls;
artichoke,
globe;
cattle,
fat;
corn,
field,
grain;
corn,
field,
forage;
corn,
field,
stover;
corn,
oil;
corn,
aspirated
grain
fractions;
corn,
sweet
(
K
+
CWHR);
corn,
sweet,
forage;
corn,
sweet,
stover;
fruit,
stone,
group
(
except
plum,
fresh
prune);
goat,
fat;
grape;
horse,
fat;
lime,
Spanish;
longan;
lychee;
milk;
nut,
tree,
group;
pistachio;
plum
(
fresh
prune);
poultry,
fat;
poultry,
meat;
pulasan;
raisin;
rambutan;
sheep,
fat;
vegetable,
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67,
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183
/
Friday,
September
20,
2002
/
Rules
and
Regulations
fruiting
(
except
cucurbits),
group;
vegetable,
leafy
(
except
Brassica),
leafy
greens
subgroup;
vegetable,
leafy
(
except
Brassica),
leaf
petioles
subgroup;
vegetable,
leafy,
Brassica
(
cole),
head
and
stem
subgroup;
vegetable,
leafy,
Brassica
(
cole),
greens
subgroup
at
25.0,
3.0,
0.50,
0.05,
15.0,
125.0,
0.20,
2.0,
0.05,
30.0,
60.0,
3.0,
0.50,
1.0,
0.50,
2.0,
2.0,
2.0,
0.10,
0.10,
0.10,
0.30,
0.02,
0.02,
2.0,
1.5,
2.0,
0.5,
2.0,
30.0,
25.0,
7.0
and
30.0
ppm
respectively,
and
for
the
combined
residues
of
methoxyfenozide
and
its
glucuronide
metabolite
in
or
on
cattle,
liver;
cattle,
meat
byproducts
(
except
liver);
eggs;
goat,
liver;
goat
meat
byproducts
(
except
liver);
horse,
liver;
horse,
meat
byproducts
(
except
liver);
poultry,
liver;
poultry,
meat
byproducts
(
except
liver);
sheep,
liver;
and
sheep,
meat
byproducts
(
except
liver)
at
0.40,
0.10,
0.02,
0.40,
0.10,
0.40,
0.10,
0.10,
0.02,
0.40
and
0.10
ppm,
respectively.
EPA
also
has
sufficient
data
to
assess
the
hazards
of
and
to
make
a
determination
on
aggregate
exposure,
consistent
with
section
408(
b)(
2),
for
time
limited
tolerances
for
the
indirect
or
inadvertent
residues
for
methoxyfenozide
in
or
on
vegetable,
bulb,
group;
vegetable,
root
and
tuber,
group;
and
vegetable,
root
and
tuber,
leaves,
group
when
present
therein
as
a
result
of
the
application
of
methoxyfenozide
to
growing
crops
at
0.20,
0.10
and
0.20
ppm,
respectively
and
time
limited
indirect
or
inadvertent
combined
residues
for
methoxyfenozide
and
its
metabolites
RH
117,236
free
phenol
of
methoxyfenozide;
3,5
dimethylbenzoic
acid
N
tert
butyl
N'(
3
hydroxy
2
methylbenzoyl)
hydrazide],
RH
151,055
glucose
conjugate
of
RH
117,236;
3,5
dimethylbenzoicacid
Ntert
butyl
N[
3(
b
D
glucopyranosyloxy)
2
methylbenzoyl]
hydrazide
and
RH
152,072
the
malonylglycosyl
conjugate
of
RH
117,236
in
or
on
animal
feed,
non
grass
(
forage,
fodder,
straw,
hay),
group;
grain,
cereal,
forage,
fodder,
and
straw,
group;
grass,
forage,
fodder,
and
hay,
group;
herbs
and
spices,
group;
vegetable,
legume,
group;
and
vegetable,
legume,
foliage,
group
when
present
therein
as
a
result
of
the
application
of
methoxyfenozide
to
growing
crops
at
10.0,
10.0,
10.0,
10.0,
0.10
and
10.0
ppm,
respectively.
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
methoxyfenozide
are
discussed
below
as
well
as
the
no
observed
adverse
effect
level
(
NOAEL)
and
the
lowest
observed
adverse
effect
level
(
LOAEL)
from
the
toxicity
studies
reviewed.
In
an
acute
neurotoxicity
study
in
rats
(
MRID
44617802),
statistically
significant
decreased
hindlimb
grip
strength
was
observed
in
male
rats
at
3
hours
(
approximate
time
of
peak
effect)
following
a
single
oral
dose
of
2,000
milligrams/
kilogram
(
mg/
kg)
(
limit
dose)
of
methoxyfenozide.
Decreased
hindlimb
grip
strength
was
also
observed
in
the
male
rats
at
7
and
14
days,
but
was
not
statistically
significant.
No
other
systemic
or
neurotoxic
effects
were
observed
in
the
male
rats
or
in
the
female
rats
at
any
time
in
this
study.
Since
this
marginal
effect
occurred
only
in
one
sex,
was
statistically
significant
at
only
one
time,
was
observed
only
at
the
high
dose
(
limit
dose)
and
no
other
signs
of
toxicity
were
observed
in
the
rats
in
this
study,
this
possible
effect
is
not
considered
to
be
biologically
significant.
In
addition,
neither
decreased
hindlimb
grip
strength
nor
any
other
signs
of
neurotoxicity
were
observed
in
any
of
the
animals
at
any
time
in
a
90
day
subchronic
neurotoxicity
study
in
rats
(
MRID
44617803).
In
a
2
week
range
finding
dietary
study
in
rats
(
MRID
44617722),
treatment
related
effects
were
observed
at
5,000
ppm
in
the
liver
(
increased
liver
weights
and
hepatocellular
hypertrophy
in
males
and
females),
in
the
thyroid
gland
(
hypertrophy/
hyperplasia
of
follicular
cells
in
males
and
females),
and
in
the
adrenal
gland
(
increased
adrenal
weights
and/
or
hypertrophy
of
the
zona
fasciculata
in
females).
Hypertrophy/
hyperplasia
of
thyroid
follicular
cells
was
also
observed
in
males
and
females
at
1,000
ppm,
the
LOAEL
in
this
study.
The
NOAEL
was
250
ppm.
Treatmentrelated
hematological
changes
were
not
observed
in
the
rats
in
this
study.
In
a
3
month
feeding
study
in
rats
(
MRID
44617722),
the
predominant
treatment
related
effects
were
increased
liver
weights
in
males
and
females
and
periportal
hepatocellular
hypertrophy
in
all
males
and
females
at
20,000
ppm
(
highest
dose
tested)
and
at
5,000
ppm.
In
addition,
at
20,000
ppm,
a
slightly
decreased
(
7
8%)
red
blood
cell
(
RBC)
count
and
slightly
decreased
(
7
8%)
hemoglobin
concentration,
compared
to
control
rats,
were
observed
in
the
females.
The
LOAEL
in
this
study
was
5,000
ppm
(
353
mg/
kg/
day
in
males
and
379
mg/
kg/
day
in
females).
The
NOAEL
was
1,000
ppm
(
69
mg/
kg/
day
in
males
and
72
mg/
kg/
day
in
females).
Although
observed
in
the
2
week
dietary
study
and
in
the
2
year
chronic
feeding/
carcinogenicity
study
in
rats,
treatmentrelated
effects
in
the
thyroid
and
adrenal
glands
were
not
observed
in
the
rats
in
this
3
month
study.
There
is
no
available
biological
explanation
for
this
difference
in
findings
in
the
studies.
In
a
2
year
combined
chronic
feeding/
carcinogenicity
study
in
rats
(
MRID
44617731),
the
following
treatment
related
effects
were
observed
at
20,000
ppm
(
highest
dose
tested):
decreased
survival
in
males,
decreased
body
weight
and
food
efficiency
in
females
during
the
last
year
of
the
study,
hematological
changes
(
decreased
RBC
counts,
hemoglobin
concentrations,
and/
or
hematocrits;
methemoglobinemia;
and
increased
platelet
counts)
in
males
and
females,
increased
liver
weights
and
periportal
hepatocellular
hypertrophy
in
males
and
females,
thyroid
follicular
cell
hypertrophy
in
males,
altered
thyroid
colloid
in
males
and
females,
and
increased
adrenal
weights
in
males
and
females.
At
8,000
ppm,
the
following
treatment
related
effects
were
observed:
hematological
changes
(
decreased
RBC
counts,
hemoglobin
concentrations,
and/
or
hematocrits
in
males
and
females),
liver
toxicity
(
increased
liver
weights
in
males
and
periportal
hepatocellular
hypertrophy
in
males
and
females),
histopathological
changes
in
the
thyroid
(
increased
follicular
cell
hypertrophy
in
males
and
altered
colloid
in
males)
and
possible
adrenal
toxicity
(
increased
adrenal
weights
in
males
and
females).
The
LOAEL
in
this
study
was
8,000
ppm
(
411
mg/
kg/
day
in
males
and
491
mg/
kg/
day
in
females),
based
on
the
effects
described
above.
The
NOAEL
was
200
ppm
(
10.2
mg/
kg/
day
in
males
and
11.9
mg/
kg/
day
in
females).
This
NOAEL
was
used
to
establish
the
RfD
for
methoxyfenozide.
Utilizing
an
uncertainty
factor
(
UF)
of
100
to
account
for
both
interspecies
extrapolation
(
10X)
and
intraspecies
variability
(
10X),
the
chronic
RfD
for
methoxyfenozide
was
calculated
to
be
0.10
mg/
kg/
day.
No
evidence
of
carcinogenicity
was
observed
in
this
study.
Dosing
was
considered
adequate
because
of
the
decreased
survival
in
males
and
the
decreased
body
weights
and
food
efficiency
in
females
at
20,000
ppm.
In
addition,
the
highest
dose
tested
for
both
males
and
females,
20,000
ppm
(
1,045
mg/
kg/
day
males
and
1,248
mg/
kg/
day
in
females),
is
higher
than
the
limit
dose
of
1,000
mg/
kg/
day.
In
a
2
week
range
finding
study
in
dogs
(
MRID
44617724),
treatment
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Vol.
67,
No.
183
/
Friday,
September
20,
2002
/
Rules
and
Regulations
related
hematological
changes
were
observed
in
both
males
and
females
at
3,500
ppm,
7,000
ppm,
15,000
ppm
and
30,000
ppm
(
highest
dose
tested).
These
changes
included
decreased
RBC
counts,
decreased
hemoglobin
concentrations,
decreased
hematocrits,
decreased
MCHC,
increased
MCV,
increased
MCH,
increased
Heinz
bodies,
methemoglobinemia,
changes
in
RBC
morphology
such
as
Howell
Jolly
bodies
and
polychromasia,
increased
reticulocyte
counts,
increased
nucleated
RBC
and
increased
platelet
counts.
At
the
same
dose
levels
(
3,500
ppm),
increased
spleen
weights
and/
or
enlarged
spleens
were
also
observed.
At
7,000
ppm,
plasma
total
bilirubin
was
increased.
The
LOAEL
in
this
study
was
3,500
ppm
(
90
184
mg/
kg/
day
in
males
and
females).
The
NOAEL
was
300
ppm
(
11
16
mg/
kg/
day
in
males
and
females).
In
a
3
month
feeding
study
in
dogs
(
MRID
44617724),
no
treatment
related
effects
other
than
a
suggestion
of
decreased
body
weight
gains
in
males
and
females
were
observed
in
either
males
or
females
at
the
highest
dose
tested
viz.
5,000
ppm
(
198
mg/
kg/
day
in
males
and
209
mg/
kg/
day
in
females).
Although
hematological
effects
were
noted
in
dogs
in
the
2
week
rangefinding
study
at
3,500
ppm
(
90
184
mg/
kg/
day)
and
in
the
1
year
chronic
feeding
study
at
3,000
ppm
(
106
mg/
kg/
day
in
males
and
111
mg/
kg/
day
in
females),
hematological
changes
were
not
observed
in
this
3
month
study
at
5,000
ppm
(
198/
209
mg/
kg/
day).
There
is
no
available
biological
explanation
for
this
difference
in
findings
in
the
studies.
As
part
of
the
3
month
study
in
dogs
(
MRID
44617724),
some
male
and
female
dogs
were
given
15
ppm
(
0.6
mg/
kg/
day)
of
methoxyfenozide
in
the
diet
for
15
weeks
followed
by
an
increase
in
the
dietary
dose
to
15,000
ppm
(
422
mg/
kg/
day
in
males
and
460
mg/
kg/
day
in
females)
for
an
additional
6
weeks.
After
about
2
weeks
and
6
weeks
at
15,000
ppm,
hematological
examinations
were
conducted.
No
hematological
changes
in
these
dogs
were
observed.
Apparently,
pretreatment
of
the
dogs
at
15
ppm
for
15
weeks
prevented
the
occurrence
of
hematological
changes
which
would
have
been
expected
to
occur
based
on
results
in
the
2
week
and
1
year
feeding
studies.
One
possible
explanation
is
that
the
liver
microsomal
enzyme
system
may
have
been
stimulated
so
much
during
pretreatment
at
15
ppm
that
the
metabolic
(
detoxification
?)
rate
of
methoxyfenozide
was
increased
to
the
point
where
blood
levels
of
methoxyfenozide
may
have
remained
below
critical
effect
levels
at
15,000
ppm.
Another
possible
explanation
is
that
compensatory
mechanisms
for
replacing
damaged
RBC
in
pretreated
dogs
may
have
been
so
efficient
that
hematological
changes
were
not
observed
in
these
dogs
even
at
15,000
ppm.
Other
explanations
for
this
finding
are
also
possible.
In
a
1
year
chronic
feeding
study
in
dogs
(
MRID
44617728),
the
predominant
toxic
effects
were
anemia
and
signs
of
an
associated
compensatory
response.
At
30,000
ppm,
the
highest
dose
tested,
the
following
treatment
related
effects
were
observed
in
both
males
and
females:
decreased
RBC
counts,
decreased
hemoglobin
concentrations,
decreased
hematocrits,
methemoglobinemia,
nucleated
RBC,
increased
platelets,
increased
serum
total
bilirubin,
bilirubinurea,
increased
hemosiderin
in
macrophages
in
liver
and
spleen,
and
increased
hyperplasia
in
bone
marrow
of
rib
and
sternum.
Increased
liver
weights
in
males
and
females
and
increased
thyroid
weights
in
males
were
also
observed
at
30,000
ppm.
Signs
of
anemia
were
also
noted
at
3,000
ppm
and
included
decreased
RBC
counts,
decreased
hemoglobin
concentrations,
decreased
hematocrits,
methemoglobinemia,
increased
platelets,
and
increased
serum
total
bilirubin
and
bilirubinurea.
The
LOAEL
in
this
study
was
3,000
ppm
(
106
mg/
kg/
day
in
males
and
111
mg/
kg/
day
in
females).
The
NOAEL
was
300
ppm
(
9.8
mg/
kg/
day
in
males
and
12.6
mg/
kg/
day
in
females).
In
a
3
month
feeding
study
in
mice
(
MRID
44617723),
the
only
treatmentrelated
effect
was
decreased
body
weight
gain
in
males
and
females
at
7,000
ppm,
the
highest
dose
tested.
The
LOAEL
in
this
study
was
7,000
ppm
(
1,149
mg/
kg/
day
in
males
and
1,742
mg/
kg/
day
in
females)
and
the
NOAEL
was
2,500
ppm
(
428
mg/
kg/
day
in
males
and
589
mg/
kg/
day
in
females).
In
an
18
month
carcinogenicity
study
in
mice
(
MRID
44617729),
no
treatment
related
effects
were
observed
at
doses
up
to
and
including
the
limit
dose
of
7,000
ppm
(
1,020
mg/
kg/
day
in
males
and
1,354
mg/
kg/
day
in
females).
No
evidence
of
carcinogenicity
was
observed
in
this
study.
Dosing
was
considered
adequate
because
the
highest
dose
tested
for
both
males
and
females,
7,000
ppm
(
1,020
mg/
kg/
day
in
males
and
1,354
mg/
kg/
day
in
females,
respectively),
is
higher
than
the
limit
dose
of
1,000
mg/
kg/
day.
In
a
battery
of
four
mutagenicity
studies
(
with
and
without
metabolic
activation,
as
appropriate
for
the
specific
study),
technical
grade
methoxyfenozide
was
negative
for
genotoxicity
in
all
four
studies.
The
four
studies
satisfy
the
new
revised
mutagenicity
guideline
requirements
for
a
new
chemical
(
published
in
1991).
An
additional
mutagenicity
study,
performed
on
RH
117,236
(
Metabolite
M
B),
a
metabolite
of
methoxyfenozide,
was
also
negative
for
genotoxicity.
Based
on
the
lack
of
evidence
of
carcinogenicity
in
male
and
female
rats
as
well
as
in
male
and
female
mice
and
on
the
lack
of
genotoxicity
in
an
acceptable
battery
of
mutagenicity
studies,
methoxyfenozide
is
classified
as
a
``
not
likely''
human
carcinogen
according
to
the
EPA
Proposed
Guidelines
for
Carcinogen
Risk
Assessment
(
April
10,
1996).
In
a
developmental
toxicity
study
in
rats
(
MRID
44638201),
no
signs
of
maternal
toxicity
in
dams
or
of
developmental
toxicity
in
fetuses
were
observed
at
the
limit
dose
of
1,000
mg/
kg/
day.
The
NOAEL
in
this
study
for
both
maternal
toxicity
and
developmental
toxicity
was
1,000
mg/
kg/
day.
The
LOAEL
was
>
1,000
mg/
kg/
day.
Similarly,
in
a
developmental
toxicity
study
in
rabbits
(
MRID
44617726),
no
signs
of
maternal
toxicity
or
of
developmental
toxicity
were
observed
at
the
limit
dose
of
1,000
mg/
kg/
day.
The
NOAEL
in
this
study
for
both
maternal
toxicity
and
developmental
toxicity
was
1,000
mg/
kg/
day.
The
LOAEL
was
>
1,000
mg/
kg/
day.
In
neither
the
developmental
toxicity
study
in
rats
nor
in
the
developmental
toxicity
study
in
rabbits
was
there
any
evidence
for
increased
susceptibility
of
fetuses
to
in
utero
exposure
to
methoxyfenozide.
In
these
studies,
methoxyfenozide
was
determined
not
to
be
a
developmental
toxicant.
In
a
2
generation
(
1
litter/
generation)
reproduction
study
in
rats
(
MRID
44617727),
treatment
related
parental
toxicity
was
observed
only
at
20,000
ppm,
the
highest
dose
tested.
At
this
dose,
increased
liver
weights
were
observed
in
males
and
females
of
both
generations
and
midzonal
to
periportal
hepatocellular
hypertrophy
was
observed
in
the
livers
of
all
males
and
females
of
both
generations.
The
LOAEL
for
parental
toxicity
was
20,000
ppm
(
1,552
mg/
kg/
day
for
males
and
1,821
mg/
kg/
day
for
females)
and
the
NOAEL
was
2,000
ppm
(
153
mg/
kg/
day
for
males
and
181
mg/
kg/
day
for
females).
There
were
no
treatment
related
effects
on
reproductive
parameters
for
adult
(
parent)
animals.
The
NOAEL
for
reproductive
toxicity
was
20,000
ppm.
Since
no
treatment
related
effects
were
observed
in
the
pups,
the
NOAEL
for
neonatal
toxicity
was
also
20,000
ppm.
The
NOAEL
for
parental
toxicity
in
this
reproduction
study
is
higher
than
the
NOAEL
for
the
2
year
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chronic
feeding/
carcinogenicity
study
in
rats
because
many
of
the
toxic
effects
observed
in
the
2
year
study
at
the
LOAEL
(
hematological
changes,
liver
toxicity,
histopathological
changes
in
the
thyroid
gland
and
increased
adrenal
weights)
were
not
examined
in
the
reproduction
study.
In
a
metabolism
study
in
rats
(
MRID
44617804),
14C
methoxyfenozide
was
rapidly
absorbed,
distributed,
metabolized
and
almost
completely
excreted
within
48
hours.
The
major
route
of
excretion
was
feces
(
86
97%)
with
lesser
amounts
in
the
urine
(
5
13%).
An
enterohepatic
circulation
was
observed.
The
test
material
was
metabolized
principally
by
Odemethylation
of
the
A
ring
methoxy
group
and
oxidative
hydroxylation
of
the
B
ring
methyl
groups
followed
by
conjugation
with
glucuronic
acid.
No
significant
sex
related
or
dosedependent
differences
in
metabolic
disposition
were
noted.
Seven
metabolites
and
the
parent
accounted
for
74
90%
of
the
administered
dose
in
all
groups.
The
glucuronide
conjugates
are
considered
to
be
less
toxic
than
the
parent
compound
because
glucuronide
conjugation
is
well
known
to
be
a
commonly
occurring
``
detoxification''
mechanism
in
mammalian
species
since
it
results
in
the
formation
of
more
polar,
more
water
soluble
metabolites
which
are
readily
and
easily
excreted
from
the
body
(
in
this
case,
in
the
bile
and
urine).
Further,
based
on
similarities
of
chemical
structure,
the
non
conjugated
metabolites
would
be
expected
to
be
no
more
toxic
than
the
parent
compound.
In
a
dermal
absorption
study
in
rats
(
MRID
44638201)
using
an
80%
wettable
powder
formulation
as
the
test
material,
the
cumulative
dermal
absorption
of
test
material
after
a
10
or
24
hour
dermal
exposure
was
determined
to
be
2%.
In
a
28
day
dermal
toxicity
study
in
rats
(
MRID
44617725),
no
treatmentrelated
systemic
or
skin
effects
were
observed
at
the
limit
dose
of
1,000
mg/
kg/
day
(
HDT).
Regarding
effects
on
endocrine
organs,
methoxyfenozide
affected
the
thyroid
gland
and
adrenal
gland
in
the
2
week
and
2
year
feeding
studies
in
rats.
In
the
thyroid
gland,
hypertrophy/
hyperplasia
of
follicular
cells
and
altered
colloid
were
observed
in
males
and
females
at
or
near
the
LOAEL
in
both
of
these
studies.
In
the
adrenal
gland,
increased
adrenal
weights
and
hypertrophy
of
the
zona
fasciculata
were
also
observed
in
males
and
females
at
or
near
the
LOAEL.
In
addition,
in
the
1
year
chronic
feeding
study
in
dogs,
increased
thyroid
weight
in
males
was
observed,
but
only
at
the
very
high
dose
of
30,000
ppm.
Other
than
the
morphological
changes
described
above,
there
were
no
signs
of
thyroid
or
adrenal
dysfunction
in
these
or
in
any
other
studies
on
methoxyfenozide.
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
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
Safety
Factor.
For
non
dietary
risk
assessments
(
other
than
cancer)
the
UF
is
used
to
determine
the
LOC.
For
example,
when
100
is
the
appropriate
UF
(
10X
to
account
for
interspecies
differences
and
10X
for
intraspecies
differences)
the
LOC
is
100.
To
estimate
risk,
a
ratio
of
the
NOAEL
to
exposures
(
margin
of
exposure
(
MOE)
=
NOAEL/
exposure)
is
calculated
and
compared
to
the
LOC.
The
linear
default
risk
methodology
(
Q*)
is
the
primary
method
currently
used
by
the
Agency
to
quantify
carcinogenic
risk.
The
Q*
approach
assumes
that
any
amount
of
exposure
will
lead
to
some
degree
of
cancer
risk.
A
Q*
is
calculated
and
used
to
estimate
risk
which
represents
a
probability
of
occurrence
of
additional
cancer
cases
(
e.
g.,
risk
is
expressed
as
1
x
10
6
or
one
in
a
million).
Under
certain
specific
circumstances,
MOE
calculations
will
be
used
for
the
carcinogenic
risk
assessment.
In
this
non
linear
approach,
a
``
point
of
departure''
is
identified
below
which
carcinogenic
effects
are
not
expected.
The
point
of
departure
is
typically
a
NOAEL
based
on
an
endpoint
related
to
cancer
effects
though
it
may
be
a
different
value
derived
from
the
dose
response
curve.
To
estimate
risk,
a
ratio
of
the
point
of
departure
to
exposure
(
MOEcancer
=
point
of
departure/
exposures)
is
calculated.
A
summary
of
the
toxicological
endpoints
for
methoxyfenozide
used
for
human
risk
assessment
is
shown
in
the
following
Table
2:
TABLE
1.
SUMMARY
OF
TOXICOLOGICAL
DOSE
AND
ENDPOINTS
FOR
METHOXYFENOZIDE
FOR
USE
IN
HUMAN
RISK
ASSESSMENT
Exposure
Scenario
Dose
(
mg/
kg/
day)
Endpoint
Study
Acute
Dietary
None
No
appropriate
endpoint
was
identified
in
the
oral
toxicity
studies
including
the
acute
neurotoxicity
study
in
rats
and
the
developmental
toxicity
studies
in
rats
and
rabbits.
None
UF
=
N/
A
Acute
RfD
=
Not
Applicable
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Vol.
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183
/
Friday,
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20,
2002
/
Rules
and
Regulations
TABLE
1.
SUMMARY
OF
TOXICOLOGICAL
DOSE
AND
ENDPOINTS
FOR
METHOXYFENOZIDE
FOR
USE
IN
HUMAN
RISK
ASSESSMENT
Continued
Exposure
Scenario
Dose
(
mg/
kg/
day)
Endpoint
Study
Chronic
Dietary
(
Non
cancer)
All
Population
Subgroups
NOAEL
=
10.2
mg/
kg/
day
Hematological
changes
(
decreased
RBC,
hemoglobin
and/
or
hematocrit),
liver
toxicity
(
increased
weights,
hypertrophy),
histopathological
changes
in
thyroid
(
increased
follicular
cell
hypertrophy
altered
colloid
possible
adrenal
toxicity
(
increased
weights).
2
Year
combined
chronic
feeding/
carcinogenicity
rats
UF
=
100;
FQPA
=
1X
Chronic
RfD
=
0.10
mg/
kg/
day
Chronic
Population
Adjusted
Dose
(
cPAD)
=
0.10
mg/
kg/
day
This
cPAD
applies
to
All
population
subgroups.
Short
Term,
Intermediate
Term,
and
Long
Term
(
Dermal)
None
No
systemic
toxicity
was
seen
at
the
limit
dose
following
repeated
dermal
application
to
rats.
None
Short
Term
Intermediate
Term,
and
Long
Term
(
Inhalation)
None
Based
on
low
vapor
pressure
the
low
acute
toxicity
of
both
the
technical
and
formulated
products
as
well
as
the
application
rate
and
application
method,
there
is
minimal
concern
for
inhalation
exposure
None
Cancer
None
None.
None
*
The
reference
to
the
FQPA
Safety
Factor
refers
to
any
additional
safety
factor
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
180.544)
for
the
residues
of
methoxyfenozide,
in
or
on
a
variety
of
raw
agricultural
commodities.
Risk
assessments
were
conducted
by
EPA
to
assess
dietary
exposures
from
methoxyfenozide
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.
No
appropriate
toxicological
endpoint
attributable
to
a
single
exposure
was
identified
in
the
available
toxicology
studies
on
methoxyfenozide.
Thus,
the
risk
from
acute
exposure
is
considered
negligible.
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:
a.
A
tier
1(
assumptions:
tolerance
level
residues
and
100
percent
crop
treated
)
was
conducted.
b.
The
established
tolerances
of
40
CFR
180.544
and
the
new
tolerances
established
today
were
included
in
the
analysis.
c.
Anticipated
residues
and
percent
crop
treated
were
not
used
in
this
analysis.
d.
The
processing
factors
applied
were
the
DEEM
default
values.
As
shown
in
table
2
of
this
preamble,
the
resulting
dietary
food
exposures
occupy
up
to
34.3%
of
the
Chronic
PAD
for
the
most
highly
exposed
population
subgroup,
children,
1
6
years
old.
These
results
should
be
viewed
as
conservative
(
health
protective)
risk
estimates.
Refinements
such
as
use
of
percent
crop
treated
information
and/
or
anticipated
residue
values
would
yield
even
lower
estimates
of
chronic
dietary
exposure.
TABLE
2.
SUMMARY:
CHRONIC
DIETARY
EXPOSURE
ANALYSIS
BY
DEEM
(
TIER
1)
Population
Subgroup1
Exposure
(
mg/
kg/
day)
%
of
Chronic
PAD2
U.
S.
Population
(
Total)
0.018704
18.7
All
infants
(<
1
year
old)
0.020335
20.3
Nursing
infants
0.010197
10.2
Non
nursing
infants
0.024603
24.6
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Vol.
67,
No.
183
/
Friday,
September
20,
2002
/
Rules
and
Regulations
TABLE
2.
SUMMARY:
CHRONIC
DIETARY
EXPOSURE
ANALYSIS
BY
DEEM
(
TIER
1)
Continued
Population
Subgroup1
Exposure
(
mg/
kg/
day)
%
of
Chronic
PAD2
Children
(
1
6
years
old)
0.034286
34.3
Children
(
7
12
years
old)
0.024543
24.5
Females
13+
(
nursing)
0.021335
21.3
Non
hispanic/
non
white/
non
black
0.021910
21.9
1
The
subgroups
listed
are:
(
1)
the
U.
S.
Population
(
total);
(
2)
those
for
infants
and
children;
(
3)
the
most
highly
exposed
of
the
females
subgroups
in
this
case
Females
13+
(
nursing),
and
(
4)
the
most
highly
exposed
of
the
remaining
subgroups,
in
this
case
Non
hispanic/
non
white/
non
black.
2
Percent
Chronic
PAD
=
(
Exposure
÷
Chronic
PAD)
x
100.
iii.
Cancer.
Methoxyfenozide
is
classified
as
a
``
not
likely''
human
carcinogen.
Therefore
this
risk
is
considered
negligible.
iv.
Anticipated
residue
and
percent
crop
treated
information.
Anticipated
residue
and
percent
crop
treated
information
was
not
used
in
the
Agency's
assessment.
2.
Dietary
exposure
from
drinking
water.
The
Agency
lacks
sufficient
monitoring
exposure
data
to
complete
a
comprehensive
dietary
exposure
analysis
and
risk
assessment
for
methoxyfenozide
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
methoxyfenozide.
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.
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
methoxyfenozide
they
are
further
discussed
in
the
aggregate
risk
sections.
Based
on
the
PRZM/
EXAMS
and
SCIGROW
models
the
estimated
environmental
concentrations
(
EECs)
of
methoxyfenozide
for
acute
exposures
are
estimated
to
be
290
parts
per
billion
(
ppb)
for
surface
water
and
12
ppb
for
ground
water.
The
EECs
for
chronic
exposures
are
estimated
to
be
197
ppb
for
surface
water
and
12
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).
Methoxyfenozide
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)
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
methoxyfenozide
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,
methoxyfenozide
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
methoxyfenozide
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.
FFDCA
section
408
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
database
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
margin
of
exposure
(
MOE)
analysis
or
through
using
uncertainty
(
safety)
factors
in
calculating
a
dose
level
that
poses
no
appreciable
risk
to
humans.
2.
Prenatal
and
postnatal
sensitivity.
The
toxicology
database
for
methoxyfenozide
included
acceptable
developmental
toxicity
studies
in
both
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Regulations
rats
and
rabbits
as
well
as
a
2
generation
reproductive
toxicity
study
in
rats.
The
data
provided
no
indication
of
increased
sensitivity
of
rats
or
rabbits
to
in
utero
and/
or
postnatal
exposure
to
methoxyfenozide.
3.
Conclusion.
The
10X
safety
factor
for
the
protection
of
infants
and
children
(
as
required
by
FQPA)
has
been
removed
(
i.
e.
reduced
to
1x)
for
the
following
reasons:
The
toxicology
data
base
for
methoxyfenozide
is
complete
for
assessment
of
potential
hazard
to
infants
and
children.
Based
on
weight
of
the
evidence
considerations,
the
HIARC
determined
that
a
developmental
neurotoxicity
study
in
rats
is
not
required
to
support
the
registration
of
methoxyfenozide.
In
developmental
toxicity
studies
in
rats
and
rabbits
(
MRID
44638201,
44617726),
no
increased
susceptibility
in
fetuses
as
compared
to
maternal
animals
was
observed
following
in
utero
exposures.
In
a
2
generation
reproduction
study
in
rats
(
MRID
44617727),
no
increased
susceptibility
in
pups
as
compared
to
adults
was
observed
following
in
utero
and
post
natal
exposures.
The
exposure
assessments
will
not
underestimate
the
potential
dietary
(
food
and
drinking
water)
or
non
dietary
exposures
for
infants
and
children
from
the
use
of
methoxyfenozide.
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
EPA
are
used
to
calculate
DWLOCs:
2L/
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
in
drinking
water
as
a
part
of
the
aggregate
risk
assessment
process.
1.
Acute
risk.
No
appropriate
toxicological
endpoint
attributable
to
a
single
(
acute)
dietary
exposure
was
identified.
No
acute
risk
is
expected
from
exposure
to
methoxyfenozide.
2.
Chronic
risk.
Using
the
exposure
assumptions
described
in
this
unit
for
chronic
exposure,
EPA
has
concluded
that
exposure
to
methoxyfenozide
from
food
will
utilize
18.7%
of
the
cPAD
for
the
U.
S.
population,
24.6%
of
the
cPAD
for
non
nursing
infants
and
34.3%
of
the
cPAD
for
children
(
1
6
years
old).
There
are
no
residential
uses
for
methoxyfenozide
that
result
in
chronic
residential
exposure
to
methoxyfenozide.
In
addition,
there
is
potential
for
chronic
dietary
exposure
to
methoxyfenozide
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
the
following
Table
3:
TABLE
3.
DWLOCS
FOR
CHRONIC
(
NON
CANCER)
DIETARY
EXPOSURE
Population
Subgroup
Chronic
PAD
(
mg/
kg/
day)
Food
Exposure
(
mg/
kg/
day)
Max.
Water
Exposure
(
mg/
kg/
day)
1
SCI
GROW
(
µ
g/
L)
GENEEC
56
day
avg
(
µ
g/
L)
DWLOC
(
µ
g/
L)
2,3,4
U.
S.
Population
(
total)
0.10
0.019
0.081
12
197
2,800
Females
13+
5
0.10
0.021
0.079
12
2,400
Infants/
Children5
0.10
0.034
0.066
12
197
660
Other5
0.10
0.022
0.078
12
197
2,700
1
Maximum
Water
Exposure
(
mg/
kg/
day)
=
Chronic
PAD
(
mg/
kg/
day)
[
Chronic
Food
Exposure
+
Chronic
Residential
Exposure
(
mg/
kg/
day)].
Methoxyfenozide
has
no
registered
residential
uses.
2
DWLOC
(
µ
g/
L)
=
[
Maximum
water
Exposure
(
mg/
kg/
day)
x
body
wt
(
kg)]
÷
[(
10
3
mg/
µ
g)
x
water
consumed
daily
(
L/
day)].
µ
g/
L
=
parts
per
billion.
3
EPA
default
body
weights
are:
General
U.
S.
Population,
70
kg;
Males
(
13+
years
old),
70
kg;
Females
(
13+
years
old),
60
kg;
Other
Adult
Populations,
70
kg;
and,
All
Infants/
Children,
10
kg.
4
EPA
default
daily
drinking
rates
are
2
L/
day
for
Adults
and
1
L/
day
for
Children.
5
Within
each
of
these
subgroups,
the
subpopulation
with
the
highest
(
chronic)
food
exposure
was
selected;
namely,
Females
(
13+/
nursing);
Children
1
6
yrs;
and,
Non
hispanic/
non
white/
non
black,
respectively.
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).
Methoxyfenozide
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.
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4.
Intermediate
term
risk.
Intermediate
term
aggregate
exposure
takes
into
account
residential
exposure
plus
chronic
exposure
to
food
and
water
(
considered
to
be
a
background
exposure
level).
Methoxyfenozide
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.
Methoxyfenozide
is
classified
as
a
``
not
likely''
human
carcinogen.
Therefore,
exposure
to
methoxyfenozide
is
expected
to
create
at
most
a
negligible
risk
of
cancer.
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
methoxyfenozide
residues.
IV.
Other
Considerations
A.
Analytical
Enforcement
Methodology
1.
Enforcement
methods
for
target
crops.
Adequate
enforcement
methods
are
available
for
determination
of
methoxyfenozide
residues
in
plant
commodities.
The
similar
methods
that
are
used
vary
depending
on
the
matrices
involved.
The
enforcement
method
for
cottonseed
is
TR
34
96
88
(
high
production
liquid
chromatography
using
ultraviolet
detection
(
HPLC/
UV);
MRID
44617821),
which
has
undergone
a
successful
petition
method
validation
(
PMV)
trial
conducted
by
EPA
(
D261663).
The
enforcement
method
for
pome
fruit
(
also
proposed
for
globe
artichoke
and
lychee)
is
TR
34
98
87
(
HPLC/
UV;
MRID
44626304),
which
has
also
undergone
a
successful
PMV
trial
conducted
by
EPA
(
D261664).
The
other
proposed
enforcement
methods
are
on:
corn,
TR
34
00
38
(
HPLC/
UV;
MRID
45213504);
tree
nuts,
TR
34
00
107
(
HPLC/
UV;
MRID
45373503);
stone
fruit,
TR
34
00
109
(
HPLC/
UV;
MRID
45313302);
leafy
and
Brassica
(
cole)
vegetables,
fruiting
vegetables,
grapes
and
raisins,
TR
34
99
74
(
HPLC/
UV
or
MS;
MRID
44873410).
Adequate
confirmatory
method
validation,
radiovalidation,
and
independent
laboratory
validation
(
ILV)
data
for
these
methods
have
been
provided.
2.
Enforcement
method
for
rotational
crops.
Method
TR
34
00
41(
MRID
45194701)
is
designated
as
the
enforcement
method
for
indirect
or
inadvertent
residues
in
rotational
crops
(
D269986).
The
method
determines
residues
of
methoxyfenozide
(
HPLC/
UV)
in
high
moisture
crops;
and
residues
of
methoxyfenozide
and
its
metabolites
RH
117,236,
RH
151,055,
and
RH
152,072
(
HPLC/
MS)
in
low
moisture
crops.
Adequate
confirmatory
method
validation,
radiovalidation,
and
ILV
data
have
been
submitted.
EPA
concluded
(
D274209)
a
PMV
trial
on
this
method
was
not
needed
because
of
its
similarity
to
TR
34
98
87.
3.
Enforcement
methods
for
animal
commodities.
The
tolerance
enforcement
method
for
animal
commodities
(
except
poultry)
is
TR
34
98
106
(
MRID
44626305),
which
has
undergone
a
successful
PMV
trial
conducted
by
EPA
(
D261665).
The
method
determines
residues
of
parent
methoxyfenozide
(
HPLC/
UV)
in
fat,
cream,
milk,
and
muscle;
and
residues
of
methoxyfenozide
and
its
metabolite
RH
141,518
(
HPLC/
MS)
in
liver
and
kidney
(
D249438).
A
similar
method,
TR
34
00
40
(
MRID
45213505),
will
be
the
enforcement
method
for
poultry
commodities.
TR
34
00
40
determines
methoxyfenozide
in
fat
(
HPLC/
UV)
and
muscle
(
HPLC/
MS);
and
methoxyfenozide
and
RH
141,518
(
HPLC/
MS)
in
eggs
and
liver
(
D269969).
EPA
concluded
(
D274209)
a
PMV
trial
on
this
method
was
not
needed
because
of
its
similarity
to
TR
34
98
106.
Adequate
confirmatory
method
validation,
radiovalidation,
and
ILV
data
have
been
submitted
for
both
methods.
4.
Multiresidue
methods
testing.
Methoxyfenozide
is
not
recoverable
by
the
Food
and
Drug
Administration
multiresidue
method
protocols
of
the
Pesticide
Analytical
Method,
Volume
I
(
D249438).
Test
data
for
metabolites
RH
141,518,
RH
117,236,
RH
151,055,
and
RH
152,072
are
also
required,
but
have
not
been
submitted.
Submission
of
such
test
data
will
be
made
a
condition
of
registration.
These
methods
may
be
requested
from:
Calvin
Furlow,
PIRIB,
Information
Resources
and
Services
Division
(
7502C),
Office
of
Pesticide
Programs,
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW,
Washington,
DC
20460;
telephone
number:
(
703)
305
5229;
e
mail
address:
furlow.
calvin@
epa.
gov.
B.
International
Residue
Limits
There
are
no
Codex
or
Canadian
MRLs
established
for
residues
of
methoxyfenozide.
Mexican
MRLs
are
established
for
residues
of
methoxyfenozide
in
cottonseed
(
0.05
ppm)
and
maize
(
0.01
ppm).
The
U.
S.
tolerances
on
these
commodities
are
2.0
ppm
and
0.05
ppm,
respectively.
Based
on
the
current
use
patterns,
the
U.
S.
tolerance
levels
can
not
be
reduced
to
harmonize
with
the
Mexican
MRLs,
so
incompatibility
will
exist.
C.
Conditions
Submission
of
test
data
showing
the
recovery
of
metabolites
RH
141,518,
RH
117,236,
RH
151,055,
and
RH
152,072
through
the
multiresidue
test
protocols
of
PAM,
Vol.
1.
Submission
of
additional
field
accumulation
trials
(
the
24
reportedly
in
progress).
In
the
interim
period,
only
time
limited
tolerances
(
5
year)
should
be
established.
Submission
of
the
following
additional
field
trials,
conducted
per
their
respective
proposed
use
pattern:
Three
for
spinach
(
one
each
from
Regions
1,
2,
and
10)
Two
for
celery
(
both
from
Region
3,
preferably
using
Intrepid
2F)
Three
for
mustard
greens
(
one
each
from
Regions
2,
3,
and
10)
Two
for
plums
(
one
each
from
Regions
10
and
11)
Submission
of
the
following
additional
information
from
the
hen
feeding
study:
Results
of
analysis
(
to
be
conducted)
of
the
fat
and
meat
(
muscle)
samples
for
residues
of
RH
141,518;
Freezer
storage
stability
data
that
covers
the
period
of
time
these
poultry
fat
and
meat
(
muscle)
samples
have
been
maintained
in
storage;
and,
Revised
tolerances
and
tolerance
expression
(
to
include
RH
141,518)
for
these
matrices,
if
warranted.
V.
Conclusion
Therefore,
tolerances
are
established
for
residues
of
the
insecticide
methoxyfenozide
in
or
on
almond,
hulls;
artichoke,
globe;
cattle,
fat;
corn,
field,
grain;
corn,
field,
forage;
corn,
field,
stover;
corn,
oil;
corn,
aspirated
grain
fractions;
corn,
sweet
(
K
+
CWHR);
corn,
sweet,
forage;
corn,
sweet,
stover;
fruit,
stone,
group
(
except
plum,
fresh
prune);
goat,
fat;
grape;
horse,
fat;
lime,
Spanish;
longan;
lychee;
milk;
nut,
tree,
group;
pistachio;
plum
(
fresh
prune);
poultry,
fat;
poultry,
meat;
pulasan;
raisin;
rambutan;
sheep,
fat;
vegetable,
fruiting
(
except
cucurbits),
group;
vegetable,
leafy
(
except
Brassica),
leafy
greens
subgroup;
vegetable,
leafy
(
except
Brassica),
leaf
petioles
subgroup;
vegetable,
leafy,
Brassica
(
cole),
head
and
stem
subgroup;
vegetable,
leafy,
Brassica
(
cole),
greens
subgroup
at
25.0,
3.0,
0.50,0.05,
15.0,
125.0,
0.20,
2.0,
0.05,
30.0,
60.0,
3.0,
0.50,
1.0,0.50,
2.0,2.0,
2.0
0.10,
0.10,0.10,0.30,
0.02,
0.02,
2.0,
1.5,
2.0,
0.5,
2.0,
30.0,
25.0,
7.0
and
30.0
part
per
million
(
ppm)
respectively
and
for
the
combined
residues
of
methoxyfenozide
and
its
glucuronide
metabolite
in
or
on
cattle,
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183
/
Friday,
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20,
2002
/
Rules
and
Regulations
liver;
cattle,
meat
byproducts
(
except
liver);
eggs;
goat,
liver;
goat
meat
byproducts
(
except
liver);
horse,
liver;
horse,
meat
byproducts
(
except
liver);
poultry,
liver;
poultry,
meat
byproducts
(
except
liver);
sheep,
liver;
and
sheep,
meat
byproducts
(
except
liver)
at
0.40,
0.10,
0.02,
0.40,
0.10,
0.40,
0.10,
0.10,
0.02,
0.40
and
0.10
part
per
million
(
ppm)
respectively.
These
petitions
also
requested
that
40
CFR
180.544
be
amended
by
establishing
time
limited
tolerances
for
the
indirect
or
inadvertent
residues
for
methoxyfenozide
in
or
on
vegetable,
bulb,
group;
vegetable,
root
and
tuber,
group;
and
vegetable,
root
and
tuber,
leaves,
group
when
present
therein
as
a
result
of
the
application
of
methoxyfenozide
to
growing
crops
at
0.20,
0.10
and
0.20
part
per
million
(
ppm)
respectively
and
time
limited
indirect
or
inadvertent
combined
residues
for
methoxyfenozide
and
its
metabolites
RH
117,236
free
phenol
of
methoxyfenozide;
3,5
dimethylbenzoic
acid
N
tert
butyl
N'(
3
hydroxy
2
methylbenzoyl)
hydrazide,
RH
151,055
glucose
conjugate
of
RH
117,236;
3,5
dimethylbenzoicacid
N
tert
butyl
N
[
3(
b
D
glucopyranosyloxy)
2
methylbenzoyl]
hydrazide
and
RH
152,072
the
malonylglycosyl
conjugate
of
RH
117,236
in
or
on
animal
feed,
non
grass
(
forage,
fodder,
straw,
hay),
group;
grain,
cereal,
forage,
fodder,
and
straw,
group;
grass,
forage,
fodder,
and
hay,
group;
herbs
and
spices,
group;
vegetable,
legume,
group;
and
vegetable,
legume,
foliage,
group
when
present
therein
as
a
result
of
the
application
of
methoxyfenozide
to
growing
crops
at
10.0,
10.0,
10.0,
10.0,
0.10
and
10.0
part
per
million
(
ppm)
respectively.
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
of
1996,
EPA
will
continue
to
use
those
procedures,
with
appropriate
adjustments,
until
the
necessary
modifications
can
be
made.
The
new
section
408(
g)
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),
as
was
provided
in
the
old
FFDCA
sections
408
and
409.
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
0219
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
November
19,
2002.
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.
You
may
also
deliver
your
written
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.
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.
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.
2.
Mail
your
copies,
identified
by
docket
ID
number
OPP
2002
0219,
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.
In
person
or
by
courier,
bring
a
copy
to
the
location
of
the
PIRIB
described
in
Unit
I.
B.
2.
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
FFDCA
section
408(
d)
in
response
to
a
petition
submitted
to
the
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Vol.
67,
No.
183
/
Friday,
September
20,
2002
/
Rules
and
Regulations
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
FFDCA
section
408(
d),
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
FFDCA
section
408(
n)(
4).
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:
September
16,
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
180.544
is
revised
to
read
as
follows:
§
180.544
Methoxyfenozide;
tolerances
for
residues.
(
a)
General.
(
1)
Tolerances
are
established
for
residues
of
the
insecticide
methoxyfenozide
per
se;
benzoic
acid,
3
methoxy
2
methyl,
2
(
3,5
dimethylbenzoyl)
2(
1,1
dimethylethyl)
hydrazide
in
or
on
the
following
food
commodities:
Commodity
Parts
per
million
Almond,
hulls
............................
25
Apple,
wet
pomace
...................
7.0
Artichoke,
globe
........................
3.0
Brassica,
head
and
stem,
subgroup
.....................................
7.0
Brassica,
leafy
greens,
subgroup
.....................................
30
Cattle,
fat
..................................
0.50
Cattle,
meat
..............................
0.02
Corn,
field,
forage
.....................
15
Corn,
field,
grain
.......................
0.05
Corn,
field,
refined
oil
...............
0.20
Corn,
field,
stover
.....................
125
Corn,
sweet,
forage
..................
30
Corn,
sweet,
kernal
plus
cob
with
husks
removed
..............
0.05
Corn,
sweet,
stover
..................
60
Cotton,
gin
byproducts
.............
35
Cotton,
undelinted
seed
...........
2.0
Fruit,
pome,
group
....................
1.5
Fruit,
stone,
group,
except
fresh
prune
plum
...................
3.0
Goat,
fat
....................................
0.50
Goat,
meat
................................
0.02
Grain,
aspirated
fractions
.........
2.0
Grape
........................................
1.0
Grape,
raisin
.............................
1.5
Hog,
fat
.....................................
0.1
Hog,
meat
.................................
0.02
Horse,
fat
..................................
0.50
Horse,
meat
..............................
0.02
Leaf
petioles
subgroup
.............
25
Leafy
greens
subgroup
.............
30
Longan
......................................
2.0
Lychee
......................................
2.0
Milk
...........................................
0.10
Nut,
tree,
group
........................
0.10
Pistachio
...................................
0.10
Plum,
prune,
fresh
....................
0.30
Poultry,
fat
................................
0.02
Poultry,
meat
............................
0.02
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Rules
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Regulations
Commodity
Parts
per
million
Pulasan
.....................................
2.0
Rambutan
.................................
2.0
Sheep,
fat
.................................
0.50
Sheep,
meat
.............................
0.02
Spanish
lime
.............................
2.0
Vegetable,
fruiting,
group
.........
2.0
(
2)
For
combined
residues
of
the
insecticide
methoxyfenozide;
benzoic
acid,
3
methoxy
2
methyl,
2(
3,5
dimethylbenzoyl)
2(
1,1
dimethylethyl)
hydrazide
and
its
glucuronide
metabolite
RH
141,518;
b
DGlucopyranuronic
acid,
3[
2(
1,1
dimethylethyl)
2(
3,5
dimethylbenzoyl)
hydrazino]
carbonyl
2
methylphenyl]
in
the
following
commodities:
Commodity
Parts
per
million
Cattle,
liver
................................
0.40
Cattle,
meat
byproducts,
except
liver
........................................
0.10
Egg
...........................................
0.02
Goat,
liver
.................................
0.40
Goat,
meat
byproducts,
except
liver
........................................
0.10
Hog,
liver
..................................
0.1
Hog,
meat
byproducts,
except
liver
........................................
0.02
Horse,
liver
...............................
0.40
Horse,
meat
byproducts,
except
liver
........................................
0.10
Commodity
Parts
per
million
Poultry,
liver
..............................
0.10
Poultry,
meat
byproducts,
except
liver
................................
0.02
Sheep,
liver
...............................
0.40
Sheep,
meat
byproducts,
except
liver
................................
0.10
(
b)
Section
18
emergency
exemptions.
Time
limited
tolerances
are
established
for
the
residues
of
the
insecticide
methoxyfenozide
in
connection
with
the
use
of
the
pesticide
under
section
18
emergency
exemption
granted
by
EPA.
The
tolerances
will
expire
on
the
dates
specified
in
the
following
tables.
Commodity
Parts
per
million
Expiration/
revocation
date
Corn,
field,
forage
..................................................................................................................................................
10
12/
31/
03
Corn,
field,
grain
....................................................................................................................................................
0.02
12/
31/
03
Corn,
field,
stover
..................................................................................................................................................
75
12/
31/
03
Corn,
oil
.................................................................................................................................................................
0.1
12/
31/
03
Soybean,
aspirated
grain
fractions
........................................................................................................................
20
12/
31/
03
Soybean,
forage
....................................................................................................................................................
10
12/
31/
03
Soybean,
hay
.........................................................................................................................................................
75
12/
31/
03
Soybean,
refined
oil
...............................................................................................................................................
1.0
12/
31/
03
Soybean,
seed
.......................................................................................................................................................
0.04
12/
31/
03
(
c)
Tolerances
with
regional
registrations.
[
Reserved]
(
d)
Indirect
or
inadvertent
residues.
(
1)
Tolerances
are
established
for
the
indirect
or
inadvertent
residues
of
the
insecticide
methoxyfenozide
per
se;
benzoic
acid,
3
methoxy
2
methyl,
2
(
3,5
dimethylbenzoyl)
2(
1,1
dimethylethyl)
hydrazide
in
or
on
the
following
raw
agricultural
commodities,
when
present
therein
as
a
result
of
the
application
of
methoxyfenozide
to
growing
crops
as
listed
in
paragraph
(
a)
of
this
section:
Commodity
Parts
per
million
Expiration/
Revocation
Date
Vegetable,
bulb,
group
..........................................................................................................................................
0.20
09/
30/
07
Vegetable,
root
and
tuber,
group
..........................................................................................................................
0.10
09/
30/
07
Vegetable,
leaves
of
root
and
tuber,
group
...........................................................................................................
0.20
09/
30/
07
(
2)
Tolerances
are
established
for
the
indirect
or
inadvertent
combined
residues
of
methoxyfenozide;
benzoic
acid,
3
methoxy
2
methyl,
2(
3,5
dimethylbenzoyl)
2(
1,1
dimethylethyl)
hydrazide
and
its
metabolites
RH
117,236
free
phenol
of
methoxyfenozide;
3,5
dimethylbenzoic
acid
N
tert
butyl
N'(
3
hydroxy
2
methylbenzoyl)
hydrazide,
RH
151,055
glucose
conjugate
of
RH
117,236;
3,5
dimethyl
benzoic
acid
N
tert
butyl
N[
3
(
b
D
glucopyranosyloxy)
2
methylbenzoyl]
hydrazide
and
RH
152,072
the
malonylglycosyl
conjugate
of
RH
117,236
in
or
on
the
following
raw
agricultural
commodities,
when
present
therein
as
a
result
of
the
application
of
methoxyfenozide
to
growing
crops
as
listed
in
paragraph
(
a)
of
this
section:
Commodity
Parts
per
million
Expiration/
Revocation
Date
Animal
feed,
non
grass,
group
..............................................................................................................................
10.0
09/
30/
07
Grain,
cereal,
forage,
fodder
and
straw,
group
.....................................................................................................
10.0
09/
30/
07
Grass,
forage,
fodder,
and
hay,
group
..................................................................................................................
10.0
09/
30/
07
Herb
and
spice,
group
...........................................................................................................................................
10.0
09/
30/
07
Vegetable,
legume,
group
.....................................................................................................................................
0.10
09/
30/
07
Vegetable,
foliage
of
legume,
group
.....................................................................................................................
10.0
09/
30/
07
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Rules
and
Regulations
[
FR
Doc.
02
23996
Filed
9
19
02;
8:
45
am]
BILLING
CODE
6560
50
S
FEDERAL
COMMUNICATIONS
COMMISSION
47
CFR
Part
64
[
CC
Docket
Nos.
96
115,
96
149;
FCC
02
214]
Implementation
of
the
Telecommunications
Act
of
1996:
Telecommunications
Carriers'
Use
of
Customer
Proprietary
Network
Information
and
Other
Customer
Information;
Implementation
of
the
Non
Accounting
Safeguards
of
Sections
271
and
272
of
the
Connumications
Act
of
1934,
as
Amended
AGENCY:
Federal
Communications
Commission.
ACTION:
Final
rule.
SUMMARY:
This
document
adopts
rules
to
implement
section
222
of
the
Communications
Act
of
1934
(
as
amended
by
the
Telecommunications
Act
of
1996),
which
governs
carriers'
use
and
disclosure
of
customer
proprietary
network
information
(
CPNI).
This
document
affirms
the
continued
use
of
the
total
service
approach
to
define
what
carriers
may
do
under
section
222(
c)(
1)
without
notice
to
customers,
and
allows
a
carrier
to
choose
whether
to
use
an
opt
out
or
optin
approval
method
for
obtaining
customer
approval
for
a
carrier
to
use
its
customer's
individually
identifiable
CPNI
for
the
purpose
of
marketing
communications
related
services
to
that
customer.
Specifically,
this
document
allows
the
use
of
CPNI
by
carriers
or
disclosure
to
their
affiliated
entities
providing
communications
related
services,
as
well
as
third
party
agents
and
joint
venture
partners
providing
communications
related
services,
only
after
a
carrier
receives
a
customer's
knowing
consent
in
the
form
of
notice
and
``
opt
out''
approval.
This
document
also
permits
disclosure
of
CPNI
to
unrelated
third
parties
or
to
carrier
affiliates
that
do
not
provide
communications
related
services
requires
express
customer
consent,
described
as
``
opt
in''
approval.
This
document
also
further
refines
the
rules
governing
the
process
by
which
carriers
provide
notification
to
customers
of
their
CPNI
rights.
Specifically,
it
clarifies
the
form,
content
and
frequency
of
carrier
notices.
Additionally,
this
document
affirms
the
Federal
Communications
Commission's
conclusion
that
customers'
preferred
carrier
(
PC)
freeze
information
constitutes
CPNI
and
thereby
warrants
privacy
protection
pursuant
to
section
222,
and
announces
the
Commission's
decision
to
forbear
from
imposing
the
express
consent
requirements
announced
in
this
document
with
respect
to
PC
freezes.
This
document
also
reaffirms
existing
Commission
rules
addressing
winback
and
retention
marketing,
and
declines
to
adopt
further
rules
regarding
a
carrier's
denial
of
CPNI
to
another
carrier
with
customer
authorization.
DATES:
Effective
October
21,
2002,
except
§
§
64.2007,
64.2008,
and
64.2009,
which
contain
information
collection
requirements
that
are
not
effective
until
approved
by
the
Office
of
Management
and
Budget.
The
Federal
Communications
Commission
will
publish
a
document
in
the
Federal
Register
announcing
the
effective
date
of
these
rules.
FOR
FURTHER
INFORMATION
CONTACT:
Marcy
Greene,
Attorney
Advisor,
Competition
Policy
Division,
Wireline
Competition
Bureau,
at
(
202)
418
2410,
or
via
the
Internet
at
mgreene@
fcc.
gov.
SUPPLEMENTARY
INFORMATION:
This
is
a
summary
of
the
Commission's
Third
Report
and
Order
in
CC
Docket
Nos.
96
115
and
96
149,
adopted
July
16,
2002,
and
released
July
25,
2002.
The
complete
text
of
this
Report
and
Order
is
available
for
inspection
and
copying
during
normal
business
hours
in
the
FCC
Reference
Information
Center,
Portals
II,
445
12th
Street,
SW.,
Room
CY
A257,
Washington,
DC,
20554.
This
document
may
also
be
purchased
from
the
Commission's
duplicating
contractor,
Qualex
International,
Portals
II,
445
12th
Street,
SW.,
Room
CY
A257,
Washington,
DC
20554,
telephone
202
863
2893,
facsimile
202
863
2898,
or
via
e
mail
at
qualexint@
aol.
com.
It
is
also
available
on
the
Commission's
Web
site
at
http://
www.
fcc.
gov.
Synopsis
of
the
Report
and
Order
1.
The
Commission
resolves
in
this
Order
several
issues
in
connection
with
carriers'
use
of
customer
proprietary
network
information
(``
CPNI'')
pursuant
to
section
222
of
the
Telecommunications
Act
of
1996.
Through
section
222,
Congress
recognized
both
that
telecommunications
carriers
are
in
a
unique
position
to
collect
sensitive
personal
information
and
that
customers
maintain
an
important
privacy
interest
in
protecting
this
information
from
disclosure
and
dissemination.
The
rules
adopted
by
the
Commission
focus
on
the
nature
of
the
customer
approval
needed
before
a
carrier
can
use,
disclose
or
permit
access
to
CPNI.
2.
Background.
This
proceeding
was
initiated
in
1996
to
implement
section
222
of
the
Communications
Act
of
1934
(
as
amended),
which
governs
carriers'
use
and
disclosure
of
CPNI.
On
February
26,
1998,
the
Commission
adopted
regulations
implementing
section
222
in
its
CPNI
Order.
[
63
FR
20236,
April
24,
1998].
In
particular,
it
concluded
that
section
222(
c)(
1)
of
the
Act
allows
a
carrier
to
use
a
customer's
CPNI,
derived
from
the
complete
service
subscribed
to
from
that
carrier,
for
marketing
purposes
within
the
existing
service
relationship.
This
is
known
as
the
``
total
service
approach.''
The
Commission
also
concluded
that
carriers
must
notify
the
customer
of
the
customer's
rights
under
section
222
and
then
obtain
express
written,
oral
or
electronic
customer
approval
a
``
notice
and
opt
in''
approach
before
a
carrier
may
use
CPNI
to
market
services
outside
the
customer's
existing
service
relationship
with
that
carrier.
On
September
3,
1999,
the
Commission
released
an
Order
on
Reconsideration
[
64
FR
53242,
Oct.
1,
1999]
that
affirmed
the
opt
in
approach,
but
streamlined
the
CPNI
rules
so
that
carriers
could
use
CPNI
to
market
customer
premises
equipment
and
information
services
without
customer
approval,
and
lessened
carriers'
CPNI
record
keeping
responsibilities.
It
also
eliminated
restrictions
on
a
carrier's
ability
to
use
CPNI
to
regain
customers
that
switched
to
another
carrier,
known
as
``
winbacks.''
3.
After
the
Commission
adopted
the
Order
on
Reconsideration,
but
prior
to
its
release,
the
Court
of
Appeals
for
the
Tenth
Circuit
vacated
portions
of
the
1998
CPNI
Order.
The
court
found
that
the
Commission
did
not
show
that
the
opt
in
form
of
consent
protected
privacy
and
promoted
competition
in
a
manner
consistent
with
the
First
Amendment
of
the
U.
S.
Constitution.
4.
In
an
October
6,
2000
Order,
AT&
T
v.
Bell
Atlantic
(
denying
a
complaint
by
AT&
T
regarding
the
manner
in
which
Bell
Atlantic
markets
the
services
of
its
long
distance
affiliate
to
its
local
exchange
customers),
the
Commission
interpreted
the
Tenth
Circuit's
vacatur
as
applying
only
to
the
discrete
issue
that
was
before
the
court.
On
September
7,
2001,
the
Commission
released
a
Clarification
Order
and
Second
Further
Notice
of
Proposed
Rulemaking
[
66
FR
50140,
Oct.
2,
2001]
that
determined
that
all
CPNI
rules
except
those
relating
to
opt
in
remained
in
effect,
and
that
carriers
may
choose
to
obtain
customer
approval
by
means
of
an
opt
out
approach
until
the
Commission
adopted
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} |
EPA-HQ-OPP-2002-0222-0001 | Notice | "2002-08-28T04:00:00" | Notice of Receipt of Requests for Amendments to Delete Uses in Certain Pesticide Registrations. | 55241
Federal
Register
/
Vol.
67,
No.
167
/
Wednesday,
August
28,
2002
/
Notices
the
Federal
Register
listings
at
http://
www.
epa.
gov/
fedrgstr/.
2.
In
person.
The
Agency
has
established
an
official
record
for
this
action
under
docket
ID
number
OPP–
2002–
0213.
The
official
record
consists
of
the
documents
specifically
referenced
in
this
action,
any
public
comments
received
during
an
applicable
comment
period,
and
other
information
related
to
this
action,
including
any
information
claimed
as
Confidential
Business
Information
(CBI).
This
official
record
includes
the
documents
that
are
physically
located
in
the
docket,
as
well
as
the
documents
that
are
referenced
in
those
documents.
The
public
version
of
the
official
record
does
not
include
any
information
claimed
as
CBI.
The
public
version
of
the
official
record,
which
includes
printed,
paper
versions
of
any
electronic
comments
submitted
during
an
applicable
comment
period,
is
available
for
inspection
in
the
Public
Information
and
Records
Integrity
Branch
(PIRIB),
Rm.
119,
Crystal
Mall
#2,
1921
Jefferson
Davis
Hwy.,
Arlington,
VA,
from
8:
30
a.
m.
to
4
p.
m.,
Monday
through
Friday,
excluding
legal
holidays.
The
PIRIB
telephone
number
is
(703)
305–
5805.
C.
How
and
to
Whom
Do
I
Submit
Comments?
You
may
submit
comments
through
the
mail,
in
person,
or
electronically.
To
ensure
proper
receipt
by
EPA,
it
is
imperative
that
you
identify
docket
ID
number
OPP–
2002–
0213
in
the
subject
line
on
the
first
page
of
your
response.
1.
By
mail.
Submit
your
comments
to:
Public
Information
and
Records
Integrity
Branch
(PIRIB),
Information
Resources
and
Services
Division
(7502C),
Office
of
Pesticide
Programs
(OPP),
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460.
2.
In
person
or
by
courier.
Deliver
your
comments
to:
Public
Information
and
Records
Integrity
Branch
(PIRIB),
Information
Resources
and
Services
Division
(7502C),
OPP,
Environmental
Protection
Agency,
Rm.
119,
Crystal
Mall
#2,
1921
Jefferson
Davis
Hwy.,
Arlington,
VA.
The
PIRIB
is
open
from
8:
30
a.
m.
to
4
p.
m.,
Monday
through
Friday,
excluding
legal
holidays.
The
PIRIB
telephone
number
is
(703)
305–
5805.
3.
Electronically.
You
may
submit
your
comments
electronically
by
e
mail
to:
opp
docket@
epa.
gov,
or
you
can
submit
a
computer
disk
as
described
above.
Do
not
submit
any
information
electronically
that
you
consider
to
be
CBI.
Avoid
the
use
of
special
characters
and
any
form
of
encryption.
Electronic
submissions
will
be
accepted
in
WordPerfect
6.1/
8.0
or
ASCII
file
format.
All
comments
in
electronic
form
must
be
identified
by
docket
ID
number
OPP–
2002–
0213.
Electronic
comments
may
also
be
filed
online
at
many
Federal
Depository
Libraries.
D.
How
Should
I
Handle
CBI
that
I
Want
to
Submit
to
the
Agency?
Do
not
submit
any
information
electronically
that
you
consider
to
be
CBI.
You
may
claim
information
that
you
submit
to
EPA
in
response
to
this
document
as
CBI
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.
In
addition
to
one
complete
version
of
the
comment
that
includes
any
information
claimed
as
CBI,
a
copy
of
the
comment
that
does
not
contain
the
information
claimed
as
CBI
must
be
submitted
for
inclusion
in
the
public
version
of
the
official
record.
Information
not
marked
confidential
will
be
included
in
the
public
version
of
the
official
record
without
prior
notice.
If
you
have
any
questions
about
CBI
or
the
procedures
for
claiming
CBI,
please
consult
the
person
listed
under
FOR
FURTHER
INFORMATION
CONTACT.
E.
What
Should
I
Consider
as
I
Prepare
My
Comments
for
EPA?
You
may
find
the
following
suggestions
helpful
for
preparing
your
comments:
1.
Explain
your
views
as
clearly
as
possible.
2.
Describe
any
assumptions
that
you
used.
3.
Provide
copies
of
any
technical
information
and/
or
data
you
used
that
support
your
views.
4.
If
you
estimate
potential
burden
or
costs,
explain
how
you
arrived
at
the
estimate
that
you
provide.
5.
Provide
specific
examples
to
illustrate
your
concerns.
6.
Offer
alternative
ways
to
improve
the
registration
activity.
7.
Make
sure
to
submit
your
comments
by
the
deadline
in
this
notice.
8.
To
ensure
proper
receipt
by
EPA,
be
sure
to
identify
the
docket
control
number
assigned
to
this
action
in
the
subject
line
on
the
first
page
of
your
response.
You
may
also
provide
the
name,
date,
and
Federal
Register
citation.
II.
Registration
Applications
EPA
received
applications
as
follows
to
register
pesticide
products
containing
active
ingredients
not
included
in
any
previously
registered
products
pursuant
to
the
provision
of
section
3(
c)(
4)
of
FIFRA.
Notice
of
receipt
of
these
application
does
not
imply
a
decision
by
the
Agency
on
the
applications.
Products
Containing
Active
Ingredients
not
Included
in
any
Previously
Registered
Products
1.
File
Symbol:
72098–
T.
Applicant:
Taensa,
Inc,.
Fairfield,
CT
06430.
Product
name:
TAE–
001
Technical
Bioinsecticide.
Product
type:
Biological
Insecticide.
Active
ingredient:
Metarhizium
anisopliae
Strain
F52
at
97.6%.
Proposed
classification/
Use:
None.
For
control
of
coleopterans
on
ornamentals
in
greenhouses.
2.
File
Symbol:
72098–
I.
Applicant:
Taensa,
Inc.
Product
name:
TAE–
001
Granular
Bioinsecticide.
Product
type:
Biological
Insecticide.
Active
ingredient:
Metarhizium
anisopliae
Strain
F52
at
2%.
Proposed
classification/
Use:
None.
For
control
of
coleopterans
on
ornamentals
in
greenhouses.
3.
File
Symbol:
72098–
RR.
Applicant:
Taensa,
Inc.
Product
name:
Taenure
Bioinsecticide.
Product
type:
Biological
Insecticide.
Active
ingredient:
Metarhizium
anisopliae
Strain
F52
at
2%.
Proposed
classification/
Use:
None.
For
control
of
coleopterans
on
ornamentals
in
greenhouses.
4.
File
Symbol:
72098–
RE.
Applicant:
Taensa,
Inc.
Product
name:
Tick
EX
G.
Product
type:
Biological
Insecticide.
Active
ingredient:
Metarhizium
anisopliae
Strain
F52
at
2%.
Proposed
classification/
Use:
None.
For
the
control
of
ticks.
List
of
Subjects
Environmental
protection,
Pesticides
and
pest.
Dated:
August
19,
2002.
Kathleen
D.
Knox,
Acting
Director,
Biopesticides
and
Pollution
Prevention
Division,
Office
of
Pesticide
Programs.
[FR
Doc.
02–
21676
Filed
8–
27–
02;
8:
45
am]
BILLING
CODE
6560–
50–
S
ENVIRONMENTAL
PROTECTION
AGENCY
[OPP–
2002–
0222;
FRL–
7196–
1]
Notice
of
Receipt
of
Requests
for
Amendments
to
Delete
Uses
in
Certain
Pesticide
Registrations
AGENCY:
Environmental
Protection
Agency
(EPA).
ACTION:
Notice.
SUMMARY:
In
accordance
with
section
6(
f)(
1)
of
the
Federal
Insecticide,
Fungicide
and
Rodenticide
Act
(FIFRA),
as
amended,
EPA
is
issuing
a
notice
of
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Federal
Register
/
Vol.
67,
No.
167
/
Wednesday,
August
28,
2002
/
Notices
receipt
of
request
for
amendments
by
registrants
to
delete
uses
in
certain
pesticide
registrations.
Section
6(
f)(
1)
of
FIFRA
provides
that
a
registrant
of
a
pesticide
product
may
at
any
time
request
that
any
of
its
pesticide
registrations
be
amended
to
delete
one
or
more
uses.
FIFRA
further
provides
that,
before
acting
on
the
request,
EPA
must
publish
a
notice
of
receipt
of
any
request
on
the
Federal
Register.
DATES:
The
deletions
are
effective
on
February
24,
2003,
or
on
September
27,
2002
for
products
with
registrations
number
000400–
00490,
0042056–
00014,
and
005418–
00152,
unless
the
Agency
receives
a
withdrawal
request
on
or
before
February
24,
2003,
or
on
or
before
September
27,
2002
for
products
with
registrations
number
000400–
00490,
0042056–
00014,
and
005418–
00152.
ADDRESSES:
Withdrawal
requests
may
be
submitted
by
mail,
electronically,
or
in
person.
Please
follow
the
detailed
instructions
for
each
method
as
provided
in
Unit
I.
of
the
SUPPLEMENTARY
INFORMATION.
To
ensure
proper
receipt
by
EPA,
it
is
imperative
that
you
identify
docket
ID
number
OPP–
2002–
0222
in
the
subject
line
on
the
first
page
of
your
response.
FOR
FURTHER
INFORMATION
CONTACT:
By
mail:
James
A.
Hollins,
Office
of
Pesticide
Programs
(7502C),
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460;
telephone
number:
(703)
305–
5761;
e
mail
address:
hollins.
james@
epa.
gov.
Users
of
these
products
who
desire
continued
use
on
crops
or
sites
being
deleted
should
contact
the
applicable
registrant
on
or
before
dates
indicated
above.
SUPPLEMENTARY
INFORMATION:
I.
General
Information
A.
Does
this
Action
Apply
to
Me?
This
action
is
directed
to
the
public
in
general.
Although
this
action
may
be
of
particular
interest
to
persons
who
produce
or
use
pesticides,
the
Agency
has
not
attempted
to
describe
all
the
specific
entities
that
may
be
affected
by
this
action.
If
you
have
any
questions
regarding
the
information
in
this
notice,
consult
the
person
listed
under
FOR
FURTHER
INFORMATION
CONTACT.
B.
How
Can
I
Get
Additional
information,
Including
Copies
of
this
Document
and
Other
Related
Documents?
1.
Electronically.
You
may
obtain
electronic
copies
of
this
document
and
certain
other
related
documents
that
might
be
available
electronically,
from
the
EPA
Internet
Home
Page
at
http://
www.
epa.
gov.
To
access
this
document,
on
the
Home
Page
select
``
Laws
and
Regulations,
''
``
Regulations
and
Proposed
Rules,
''
and
then
look
up
the
entry
for
this
document
under
the
``
Federal
Register—
Environmental
Documents.
''
You
can
also
go
directly
to
the
Federal
Register
listing
at
http://
www.
epa.
gov/
fedrgstr/.
2.
In
person.
The
Agency
has
established
an
official
record
for
this
action
under
docket
ID
number
OPP–
2002–
0222.
The
official
record
consists
of
the
documents
specifically
referenced
in
this
action,
any
public
comments
received
during
an
applicable
comment
period,
and
other
information
related
to
this
action,
including
any
information
claimed
as
Confidential
Business
Information
(CBI).
This
official
record
includes
the
documents
that
are
physically
located
in
the
docket,
as
well
as
the
documents
that
are
referenced
in
those
documents.
The
public
version
of
the
official
record
does
not
include
any
information
claimed
as
CBI.
The
public
version
of
this
official
record,
which
includes
printed,
paper
versions
of
any
electronic
comments
submitted
during
as
applicable
comment
period,
is
available
for
inspection
in
the
Public
Information
and
Records
Integrity
Branch
(PIRIB),
Room
119,
Crystal
Mall
#2,
1921
Jefferson
Davis
Hwy.,
Arlington,
VA,
from
8:
30
a.
m.
to
4
p.
m.,
Monday
through
Friday,
excluding
legal
holidays.
The
PIRIB
telephone
number
is
(703)
305–
5805.
C.
How
and
to
Whom
Do
I
Submit
Withdrawal
Requests?
You
may
submit
withdrawal
requests
through
the
mail,
in
person,
or
electronically.
To
ensure
proper
receipt
by
EPA,
it
is
imperative
that
you
identify
docket
ID
number
OPP–
2002–
0222
in
the
subject
line
on
the
first
page
of
your
response.
1.
By
mail.
Submit
your
withdrawal
request
to:
James
A.
Hollins,
Office
of
Pesticide
Programs
(7502C),
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460.
2.
In
person
or
by
courier.
Deliver
your
withdrawal
request
to:
Public
Information
and
Records
Integrity
Branch
(PIRIB),
Information
Resources
and
Services
Division
(7502C),
Office
of
Pesticide
Programs
(OPP),
Environmental
Protection
Agency,
Rm.
119,
Crystal
Mall#
2,
1921
Jefferson
Davis
Hwy.,
Arlington,
VA.
The
PIRIB
is
open
from
8:
30
a.
m.
to
4
p.
m.,
Monday
through
Friday,
excluding
legal
holidays.
The
PIRIB
telephone
number
is
(703)
305–
5805.
3.
Electronically.
You
may
submit
your
withdrawal
request
electronically
by
e
mail
to:
opp
docket@
epa.
gov,
or
you
can
submit
a
computer
disk
as
described
above.
Do
not
submit
any
information
electronically
that
you
consider
to
be
CBI.
Avoid
the
use
of
special
characters
and
any
form
of
encryption.
Electronic
submissions
will
be
accepted
in
WordPerfect
6.1/
8.0
or
ASCII
file
format.
All
withdrawal
requests
in
electronic
form
must
be
identified
by
docket
ID
number
OPP–
2002–
0222.
Electronic
withdrawal
requests
may
also
be
filed
online
at
many
Federal
Depository
Libraries.
D.
How
Should
I
Handle
CBI
that
I
Want
to
Submit
to
the
Agency?
Do
not
submit
any
information
electronically
that
you
consider
to
be
CBI.
You
may
claim
information
that
you
submit
to
EPA
in
response
to
this
document
as
CBI
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.
In
addition
to
one
complete
version
of
the
withdrawal
request
that
includes
any
information
claimed
as
CBI,
a
copy
of
the
withdrawal
request
that
does
not
contain
the
information
claimed
as
CBI
must
be
submitted
for
inclusion
in
the
public
version
of
the
official
record.
Information
not
marked
confidential
will
be
included
in
the
public
version
of
the
official
record
without
prior
notice.
If
you
have
any
questions
about
CBI
or
the
procedures
for
claiming
CBI,
please
consult
the
person
listed
under
FOR
FURTHER
INFORMATION
CONTACT.
II.
What
Action
is
the
Agency
Taking?
This
notice
announces
receipt
by
the
Agency
of
applications
from
registrants
to
delete
uses
in
certain
pesticide
registrations.
These
registrations
are
listed
in
Table
1
by
registration
number,
product
name/
active
ingredient,
and
specific
uses
deleted:
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Federal
Register
/
Vol.
67,
No.
167
/
Wednesday,
August
28,
2002
/
Notices
TABLE
1.—
REGISTRATIONS
WITH
REQUESTS
FOR
AMENDMENTS
TO
DELETE
USES
IN
CERTAIN
PESTICIDE
REGISTRATIONS
Registration
no.
Product
name
Active
ingredient
Delete
From
Label
000070–
00223
AllPro
Exotherm
Termil
Chlorothalonil
Greenhouse
tomatoes
000400–
00490
Lindane
40%
Lindane
Cabbage,
cauliflower,
broccoli,
brussels
sprouts
and
radishes
001812–
00328
Trilin
10G
Trifluralin
Eggplant,
onion
uses
005481–
00153
ALCO
Equine
Spray
Dipropyl
isocinchomeronate;
piperonyl
butoxide;
pyrethrins;
N
Octyl
bicycloheptene
dicarboximide
Animals
intended
for
human
consumption
042056–
00014
TCI
Captan
Lindane
Seed
Treatment
Lindane;
Captan
Spinach,
cabbage,
cauliflower,
broccoli,
brussel
sprouts,
and
radishes
062719–
00080
Lontrel
T
Technical
Clopyralid
Residential
turf
Users
of
these
products
who
desire
continued
use
on
crops
or
sites
being
deleted
should
contact
the
applicable
registrant
before
dates
indicated
in
DATES
section
of
this
notice
to
discuss
withdrawal
of
the
application
for
amendment.
This
180–
day
period,
or
30–
day
where
indicated,
will
also
permit
interested
members
of
the
public
to
intercede
with
registrants
prior
to
the
Agency's
approval
of
the
deletion.
Table
2
includes
the
names
and
addresses
of
record
for
all
registrants
of
the
products
in
Table
1,
in
sequence
by
EPA
company
number.
TABLE
2.—
REGISTRANTS
REQUESTING
AMENDMENTS
TO
DELETE
USES
IN
CERTAIN
PESTICIDE
REGISTRATIONS
EPA
Company
no.
Company
Name
and
Address
000070
Value
Gardens
Supply,
LLC,
Box
585,
St.
Joseph,
MO
64502
000400
Crompton
Mfg.
Co.,
Inc.,
74
Amity
Rd,
Bethany,
CT
06524
001812
Griffin
L.
L.
C.,
Box
1847,
Valdosta,
GA
31603
005481
AMVAC
Chemical
Corp.,
Attn:
Jon
C.
Wood,
4695
Macarthur
Ct.,
Suite
1250,
Newport
Beach,
CA
92660
042056
Trace
Chemicals
LLC,
2320
Lakecrest
Drive,
Pekin,
IL
61554
062719
Dow
Agrosciences
LLC,
9330
Zionsville
Rd
308/
2E225,
Indianapolis,
IN
46268
III.
What
is
the
Agency
Authority
for
Taking
This
Action?
Section
6(
f)(
1)
of
FIFRA
provides
that
a
registrant
of
a
pesticide
product
may
at
any
time
request
that
any
of
its
pesticide
registrations
be
amended
to
delete
one
or
more
uses.
The
Act
further
provides
that,
before
acting
on
the
request,
EPA
must
publish
a
notice
of
receipt
of
any
such
request
in
the
Federal
Register.
Thereafter,
the
Administrator
may
approve
such
a
request.
IV.
Procedures
for
Withdrawal
of
Request
Registrants
who
choose
to
withdraw
a
request
for
use
deletion
must
submit
such
withdrawal
in
writing
to
James
A.
Hollins,
at
the
address
under
FOR
FURTHER
INFORMATION
CONTACT,
postmarked
on
or
before
February
24,
2003,
or
on
or
before
September
27,
2002
for
products
with
registrations
number
000400–
00490,
0042056–
00014,
and
005418–
00152.
V.
Provisions
for
Disposition
of
Existing
Stocks
The
Agency
has
authorized
the
registrants
to
sell
or
distribute
product
under
the
previously
approved
labeling
for
a
period
of
18
months
after
approval
of
the
revision,
unless
other
restrictions
have
been
imposed,
as
in
special
review
actions.
There
is
a
12–
month
existing
stocks
provision
for
Dow
AgroSciences,
EPA
Registration
Number
062719–
00080,
after
approval
of
revised
label.
List
of
Subjects
Environmental
protection,
Pesticides
and
pests.
Dated:
August
16,
2002.
Arnold
E.
Layne,
Acting
Director,
Information
Resources
and
Services
Division.
[FR
Doc.
02–
21677
Filed
8–
27–
02;
8:
45
am]
BILLING
CODE
6560–
50–
S
ENVIRONMENTAL
PROTECTION
AGENCY
[OPP–
2002–
0185
FRL–
7194–
6]
Notice
of
Filing
a
Pesticide
Petition
to
Establish
a
Tolerance
for
a
Certain
Pesticide
Chemical
in
or
on
Food
AGENCY:
Environmental
Protection
Agency
(EPA).
ACTION:
Notice.
SUMMARY:
This
notice
announces
the
initial
filing
of
a
pesticide
petition
proposing
the
establishment
of
regulations
for
residues
of
a
certain
pesticide
chemical
in
or
on
various
food
commodities.
DATES:
Comments,
identified
by
docket
ID
number
OPP–
2002–
0185,
must
be
received
on
or
before
September
27,
2002.
ADDRESSES:
Comments
may
be
submitted
by
mail,
electronically,
or
in
person.
Please
follow
the
detailed
instructions
for
each
method
as
provided
in
Unit
I.
C.
of
the
SUPPLEMENTARY
INFORMATION.
To
ensure
proper
receipt
by
EPA,
it
is
imperative
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"license": "Public Domain",
"url": "https://downloads.regulations.gov/EPA-HQ-OPP-2002-0222-0001/content.txt"
} |
EPA-HQ-OPP-2002-0222-0002 | Notice | "2002-09-20T04:00:00" | Notice of Receipt of Requests for Amendment to Delete Uses in Certain Pesticide Registration
| 59287
Federal
Register
/
Vol.
67,
No.
183
/
Friday,
September
20,
2002
/
Notices
priorities—
reductions
in
greenhouse
gas
emissions
and
smog,
improved
water
quality
and
infrastructure,
increased
recycling
of
hazardous
waste,
and
enhanced
environmental
protection
in
agriculture;
and
the
potential
to
expand
the
voluntary
use
of
EMS
among
companies
in
the
industry.
Trade
associations
should
communicate
their
interest
to
EPA
by
letter
or
e
mail
to
the
contact
listed
below.
The
Agency
encourages
prior
telephone
contact
and
consultation.
EPA
would
like
to
invite
an
initial
group
of
industries
to
work
with
the
Agency
in
this
new
program
starting
in
December
2002.
Additional
industries
may
be
invited
to
participate
in
the
future.
DATES:
Contact
by
October
31,
2002.
FOR
FURTHER
INFORMATION
CONTACT:
Robert
Benson,
Director,
Sector
Strategies
Division
(mail
code
1808T),
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460.
E
mail:
benson.
robert@
epa.
gov.
Telephone:
202–
566–
2954.
Dated:
September
17,
2002.
Thomas
J.
Gibson,
Associate
Administrator
for
Policy,
Economics
and
Innovation.
[FR
Doc.
02–
23993
Filed
9–
19–
02;
8:
45
am]
BILLING
CODE
6560–
50–
P
ENVIRONMENTAL
PROTECTION
AGENCY
[OPP–
2002–
0222;
FRL–
7274–
3]
Notice
of
Receipt
of
Requests
for
Amendments
to
Delete
Uses
in
Certain
Pesticide
Registrations;
Correction
AGENCY:
Environmental
Protection
Agency.
ACTION:
Notice;
Correction.
SUMMARY:
EPA
is
correcting
the
``
DATES''
section
and
Unit
IV
of
the
deletion
of
uses
document
which
was
published
in
the
Federal
Register
on
August
28,
2002
(67
FR
55241)
(FRL–
7196–
1)
to
correct
one
registration
number
and
to
add
one
registration
number
that
was
inadvertently
omitted.
DATES:
The
deletions
are
effective
on
February
24,
2003,
or
on
September
27,
2002
for
products
with
registration
numbers
000400–
00490,
042056–
00014,
005418–
00153
and
062719–
00080.
FOR
FURTHER
INFORMATION
CONTACT:
By
mail:
James
A.
Hollins,
Office
of
Pesticide
Programs
(7502C),
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460;
telephone
number:
(703)
305–
5761;
e
mail
address:
hollins.
james@
epa.
gov.
In
FR
Doc.
02–
21677,
published
in
the
Federal
Register
of
August
28,
2002,
at
page
55241,
make
the
following
corrections:
1.
The
``
DATES''
section
is
corrected
to
read
as
set
forth
above.
2.
Unit
IV
is
corrected
to
read
as
follows:
IV.
Procedures
for
Withdrawal
of
Request
Registrants
who
choose
to
withdraw
a
request
for
use
deletion
must
submit
such
withdrawal
in
writing
to
James
A.
Hollins,
at
the
address
under
FOR
FURTHER
INFORMATION
CONTACT,
postmarked
on
or
before
February
24,
2003,
or
on
or
before
September
27,
2002
for
products
with
registration
numbers
00400–
00490,
042056–
00014,
005418–
00153
and
062719–
00080.
Dated:
September
9,
2002.
Linda
Vlier
Moos,
Acting
Director,
Information
Resources
and
Services
Division,
Office
of
Pesticide
Programs.
[FR
Doc.
02–
23994
Filed
9–
19–
02;
8:
45
a.
m.]
BILLING
CODE
6560–
50–
S
ENVIRONMENTAL
PROTECTION
AGENCY
[FRL–
6724–
2A]
Developing
Assessment
Factors
for
Evaluating
the
Quality
of
Information
From
External
Sources;
Notice
of
Public
Meeting
AGENCY:
Environmental
Protection
Agency
(EPA).
ACTION:
Notice
of
comment
period
extension
SUMMARY:
This
document
is
being
issued
to
extend
the
comment
period
date
regarding
the
EPA
draft
document,
``
Assessment
Factors
for
Evaluating
the
Quality
of
Information
from
External
Sources,
''
from
the
original
end
date
of
September
20,
2002
to
September
30,
2002.
The
comment
period
will
now
be
September
6,
2002
to
September
30,
2002.
DATES:
The
public
meeting
will
be
held
on
September
20,
2002,
from
9
a.
m.
to
1
p.
m.
(Eastern
Standard
Time,
EST).
Written
comments
must
be
received
on
or
before
September
30,
2002,
11:
59
p.
m.
EST.
For
information
on
dates
for
submission
of
written
comments,
requests
to
present
oral
comments,
or
requests
for
special
seating
arrangements,
see
Unit
I.
C.
of
the
SUPPLEMENTARY
INFORMATION.
ADDRESSES:
This
meeting
will
be
held
at
the
U.
S.
Environmental
Protection
Agency
East
Building,
Public
Hearing
Room
1153,
1201
Constitution
Avenue,
NW.,
Washington,
DC.
Comments
may
be
submitted
by
e
mail,
mail,
courier
or
in
person.
See
SUPPLEMENTARY
INFORMATION
for
instructions
on
submitting
comments
and
public
meeting
information.
FOR
FURTHER
INFORMATION
CONTACT:
Greg
Schweer,
Office
of
Science
Coordination
and
Policy
(7203M),
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460;
telephone
number:
(202)
564–
8469;
fax
number:
(202)
564–
8482;
e
mail
address:
assessment.
factors@
epa.
gov.
SUPPLEMENTARY
INFORMATION:
I.
General
Information
A.
Does
This
Action
Apply
to
Me?
This
action
is
directed
to
the
public
in
general.
This
action
may,
however,
be
of
interest
to
persons
or
entities
who
develop
or
collect
information
which
is
voluntarily
submitted
to
EPA
or
obtained
by
EPA
for
its
use.
Since
other
entities
may
also
be
interested,
the
Agency
has
not
attempted
to
describe
all
the
specific
entities
that
may
be
affected
by
this
action.
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
Additional
Information,
Including
Copies
of
This
Document
and
Other
Related
Documents?
1.
Electronically.
You
may
obtain
electronic
copies
of
this
document,
and
certain
other
related
documents
that
might
be
available
electronically,
from
the
EPA
Internet
Home
Page
at
http://
www.
epa.
gov.
To
access
this
document,
on
the
Home
Page
select
``
Laws
and
Regulations,
''
``
Regulations
and
Proposed
Rules,
''
and
then
look
up
the
entry
for
this
document
under
the
``
Federal
Register
Environmental
Documents.
''
You
can
also
go
directly
to
the
Federal
Register
listings
at:
http://
www.
epa.
gov/
fedrgstr.
You
may
obtain
electronic
copies
of
the
draft
``
Assessment
Factors
for
Evaluating
the
Quality
of
Information
from
External
Sources''
from
the
Information
Quality
Guidelines
Home
Page
at:
http://
www.
epa.
gov/
oei/
qualityguidelines/.
2.
In
person.
The
Agency
has
established
a
docket
for
this
meeting
under
docket
ID
number
OEI–
10014.
The
docket
consists
of
the
documents
specifically
referenced
in
this
notice,
any
public
comments
received
during
an
applicable
comment
period,
and
other
material
information,
including
any
information
claimed
as
Confidential
Business
Information
(CBI).
The
public
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| epa | 2024-06-07T20:31:43.273117 | regulations | {
"license": "Public Domain",
"url": "https://downloads.regulations.gov/EPA-HQ-OPP-2002-0222-0002/content.txt"
} |
EPA-HQ-OPP-2002-0223-0001 | Notice | "2002-10-23T04:00:00" | Availability of the Report on FQPA Tolerance Progress and Risk Management Decision (TRED) for
Metolachlor | 65120
Federal
Register
/
Vol.
67,
No.
205
/
Wednesday,
October
23,
2002
/
Notices
8.
To
ensure
proper
receipt
by
EPA,
be
sure
to
identify
the
docket
ID
number
assigned
to
this
action
in
the
subject
line
on
the
first
page
of
your
response.
You
may
also
provide
the
name,
date,
and
Federal
Register
citation.
II.
What
Action
is
the
Agency
Taking?
EPA
has
reassessed
the
risks
associated
with
current
food
uses
of
the
pesticide
hexazinone,
reassessed
25
existing
tolerances,
and
reached
a
tolerance
reassessment
and
risk
management
decision.
The
Agency
is
issuing
for
comment
the
resulting
report
on
FQPA
tolerance
reassessment
progress,
including
the
Hexazinone
Overview,
Hexazinone
Summary,
Hexazinone
Decision
Document
(TRED),
and
supporting
risk
assessment
documents.
EPA
must
review
tolerances
and
tolerance
exemptions
that
were
in
effect
when
FQPA
was
enacted
in
August
1996,
to
ensure
that
these
existing
pesticide
residue
limits
for
food
and
feed
commodities
meet
the
safety
standard
established
by
the
new
law.
Tolerances
are
considered
reassessed
once
the
safety
finding
has
been
made
or
a
revocation
occurs.
EPA
has
reviewed
and
made
the
requisite
safety
finding
for
the
tolerances
and
exemptions
included
in
this
notice.
EPA
completed
the
hexazinone
Reregistration
Eligibility
Decision
(RED)
prior
to
the
1996
enactment
of
the
FQPA;
therefore,
while
no
reregistration
decision
is
required
at
present,
risks
from
non
occupational
exposure
to
hexazinone
through
food,
drinking
water,
and
residential
uses
must
be
reassessed.
There
are
no
residential
uses
of
hexazinone.
The
Agency
has
reassessed
the
25
tolerances
for
hexazinone
and
determined
that
residues
in
food
and
drinking
water
are
not
expected
to
pose
risk
concerns.
Because
existing
data
were
inadequate
to
calculate
residue
estimates
for
pasture
and
rangeland
grass
and
grass
hay,
EPA
constructed
the
maximum
theoretical
dietary
burden
(MTDB)
of
hexazinone
to
livestock
using
protective
assumptions
for
the
contributions
of
other
hexazinone
treated
feed
items.
Thus,
tolerances
for
meats
and
milk
can
be
reassessed.
Additional
field
trial
data
for
grass
forage
and
grass
hay,
as
well
as
rotational
crop
studies
for
corn
and
wheat
are
required.
Because
of
the
relatively
low
volume
of
use
on
pasture
and
rangeland,
data
from
these
confirmatory
studies
are
not
expected
to
significantly
change
current
dietary
risk
estimates.
Some
tolerances
may
be
revised
once
additional
data
has
been
submitted
to
and
reviewed
by
the
Agency.
The
current
tolerance
expression
for
hexazinone
in
40
CFR
180.396
is
for
``
combined
residues
of
the
herbicide
hexazinone
(3
cyclohexyl
6
(dimethylamino)
1
methyl
1,3,5
triazine
2,4(
1H,
3H)
dione)
and
its
metabolites,
calculated
as
hexazinone.
''
The
tolerance
expression
should
be
modified
to
include
specific
metabolites
A,
B,
C,
D,
and
E,
identified
by
the
appropriate
chemical
name.
Final
tolerances
are
being
proposed
as
part
of
this
Tolerance
Reassessment
Decision
(TRED).
In
addition,
occupational
and
ecological
risk
management
decisions
were
made
as
part
of
the
1994
hexazinone
RED.
EPA
works
with
affected
parties
to
reach
the
tolerance
reassessment
decisions.
The
Agency
therefore
is
issuing
the
hexazinone
decision
as
a
final
decision
with
a
public
comment
period.
All
comments
received
during
the
public
comment
period
will
be
considered
by
the
Agency.
If
any
comment
significantly
affects
the
Agency's
decision,
EPA
will
publish
an
amendment
to
the
decision
in
the
Federal
Register.
In
the
absence
of
substantive
comments,
the
tolerance
reassessment
decisions
reflected
here
will
be
considered
final.
List
of
Subjects
Environmental
protection,
Chemicals,
Pesticides
and
pests.
Dated:
October
4,
2002.
Betty
Shackleford,
Acting
Director,
Special
Review
and
Reregistration
Division,
Office
of
Pesticide
Programs.
[FR
Doc.
02–
26577
Filed
10–
22–
02;
8:
45
am]
BILLING
CODE
6560–
50–
S
ENVIRONMENTAL
PROTECTION
AGENCY
[OPP–
2002–
0223;
FRL–
7274–
1]
Availability
of
the
Report
on
FQPA
Tolerance
Reassessment
Progress
and
Risk
Management
Decision
(TRED)
for
Metolachlor
AGENCY:
Environmental
Protection
Agency
(EPA).
ACTION:
Notice.
SUMMARY:
This
notice
announces
the
availability
of
the
report
on
the
Food
Quality
Protection
Act
(FQPA)
tolerance
reassessment
progress
and
Risk
Management
Decision
(TRED)
for
metolachlor
for
public
comment.
EPA
has
reassessed
the
81
tolerances,
or
legal
limits,
established
for
residues
of
metolachlor
in/
on
raw
agricultural
commodities
(RACs).
These
tolerances
are
now
considered
safe
under
the
Federal
Food,
Drug,
and
Cosmetic
Act
(FFDCA),
as
amended
by
the
FQPA
of
1996.
DATES:
Comments,
identified
by
docket
ID
number
OPP–
2002–
0223,
must
be
received
on
or
before
November
22,
2002.
ADDRESSES:
Comments
may
be
submitted
by
mail,
electronically,
or
in
person.
Please
follow
the
detailed
instructions
for
each
method
as
provided
in
Unit
I.
of
the
SUPPLEMENTARY
INFORMATION.
To
ensure
proper
receipt
by
EPA,
it
is
imperative
that
you
identify
docket
ID
number
OPP–
2002–
0223
in
the
subject
line
on
the
first
page
of
your
response.
FOR
FURTHER
INFORMATION
CONTACT:
Anne
Overstreet,
Special
Review
and
Reregistration
Division
(7508C),
Office
of
Pesticide
Programs,
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460;
telephone
number:
(703)
308–
8068;
fax
number:
(703)
308–
8005;
e
mail
address:
overstreet.
anne@
epa.
gov.
SUPPLEMENTARY
INFORMATION:
I.
General
Information
A.
Does
this
Action
Apply
to
Me?
This
action
is
directed
to
the
public
in
general,
but
will
be
of
interest
to
a
wide
range
of
stakeholders,
including
environmental,
human
health,
and
agricultural
advocates;
the
chemical
industry;
pesticide
users;
and
members
of
the
public
interested
in
the
use
of
pesticides.
The
Agency
has
not
attempted
to
describe
all
the
persons
or
entities
who
may
be
interested
in
or
affected
by
this
action.
If
you
have
questions
in
this
regard,
consult
the
person
listed
under
FOR
FURTHER
INFORMATION
CONTACT.
B.
How
Can
I
Get
Additional
Information,
Including
Copies
of
this
Document
and
Other
Related
Documents?
1.
Electronically.
You
may
obtain
electronic
copies
of
this
document,
and
certain
other
related
documents
that
might
be
available
electronically,
from
the
EPA
Internet
Home
Page
at
http://
www.
epa.
gov/.
To
access
this
document,
on
the
Home
Page
select
``
Laws
and
Regulations,
''
``
Regulations
and
Proposed
Rules,
''
and
then
look
up
the
entry
for
this
document
under
the
``
Federal
Register—
Environmental
Documents.
''
You
can
also
go
directly
to
the
Federal
Register
listings
at
http://
www.
epa.
gov/
fedrgstr/.
You
can
obtain
copies
of
the
TRED
and
related
documents
discussed
in
this
notice
on
EPA's
website
at
http://
www.
epa.
gov/
pesticides/
reregistration/
status.
htm.
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Federal
Register
/
Vol.
67,
No.
205
/
Wednesday,
October
23,
2002
/
Notices
Available
documents
include
the
TRED,
supporting
technical
documents,
and
Federal
Register
notices.
Information
on
pesticide
reregistration
and
tolerance
reassessment,
including
the
purpose
and
status
of
Agency
programs
to
complete
Reregistration
Eligibility
Decisions
(REDs),
Interim
REDs,
and
Tolerance
Reassessment
Decisions
(TREDs),
is
available
at
http:/
/www.
epa.
gov/
pesticides/
tolerance.
General
information
is
available
on
the
Office
of
Pesticide
Programs'
Home
Page,
http://
www.
epa.
gov/
pesticides.
2.
In
person.
The
Agency
has
established
an
official
record
for
this
action
under
docket
ID
number
OPP–
2002–
0223.
The
official
record
consists
of
the
documents
specifically
referenced
in
this
action,
and
other
information
related
to
this
action,
including
any
information
claimed
as
Confidential
Business
Information
(CBI).
This
official
record
includes
the
documents
that
are
physically
located
in
the
docket,
as
well
as
the
documents
that
are
referenced
in
those
documents.
The
public
version
of
the
official
record
does
not
include
any
information
claimed
as
CBI.
The
public
version
of
the
official
record,
which
includes
printed,
paper
versions
of
any
electronic
comments
submitted
during
an
applicable
comment
period,
is
available
for
inspection
in
the
Public
Information
and
Records
Integrity
Branch
(PIRIB),
Rm.
119,
Crystal
Mall
#2,
1921
Jefferson
Davis
Hwy.,
Arlington,
VA,
from
8:
30
a.
m.
to
4
p.
m.,
Monday
through
Friday,
excluding
legal
holidays.
The
PIRIB
telephone
number
is
(703)
305–
5805.
C.
How
and
to
Whom
Do
I
Submit
Comments?
You
may
submit
comments
through
the
mail,
in
person,
or
electronically.
To
ensure
proper
receipt
by
EPA,
it
is
imperative
that
you
identify
docket
ID
number
OPP–
2002–
0223
in
the
subject
line
on
the
first
page
of
your
response.
1.
By
mail.
Submit
your
comments
to:
Public
Information
and
Records
Integrity
Branch
(PIRIB),
Information
Resources
and
Services
Division
(7502C),
Office
of
Pesticide
Programs
(OPP),
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460.
2.
In
person
or
by
courier.
Deliver
your
comments
to:
Public
Information
and
Records
Integrity
Branch
(PIRIB),
Information
Resources
and
Services
Division
(7502C),
Office
of
Pesticide
Programs
(OPP),
Environmental
Protection
Agency,
Rm.
119,
Crystal
Mall
#2,
1921
Jefferson
Davis
Highway,
Arlington,
VA.
The
PIRIB
is
open
from
8:
30
a.
m.
to
4
p.
m.,
Monday
through
Friday,
excluding
legal
holidays.
The
PIRIB
telephone
number
is
(703)
305–
5805.
3.
Electronically.
You
may
submit
your
comments
electronically
by
e
mail
to:
opp
docket@
epa.
gov,
or
you
can
submit
a
computer
disk
as
described
above.
Do
not
submit
any
information
electronically
that
you
consider
to
be
CBI.
Avoid
the
use
of
special
characters
and
any
form
of
encryption.
Electronic
submissions
will
be
accepted
in
WordPerfect
6.1/
8.0/
9.0
or
ASCII
file
format.
All
comments
in
electronic
form
must
be
identified
by
docket
ID
number
OPP–
2002–
0223.
Electronic
comments
may
also
be
filed
online
at
many
Federal
Depository
Libraries.
D.
How
Should
I
Handle
CBI
That
I
Want
to
Submit
to
the
Agency?
Do
not
submit
any
information
electronically
that
you
consider
to
be
CBI.
You
may
claim
information
that
you
submit
to
EPA
in
response
to
this
document
as
CBI
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.
In
addition
to
one
complete
version
of
the
comment
that
includes
any
information
claimed
as
CBI,
a
copy
of
the
comment
that
does
not
contain
the
information
claimed
as
CBI
must
be
submitted
for
inclusion
in
the
public
version
of
the
official
record.
Information
not
marked
confidential
will
be
included
in
the
public
version
of
the
official
record
without
prior
notice.
If
you
have
any
questions
about
CBI
or
the
procedures
for
claiming
CBI,
please
consult
the
person
listed
under
FOR
FURTHER
INFORMATION
CONTACT.
E.
What
Should
I
Consider
as
I
Prepare
My
Comments
for
EPA?
You
may
find
the
following
suggestions
helpful
for
preparing
your
comments:
1.
Explain
your
views
as
clearly
as
possible.
2.
Describe
any
assumptions
that
you
used.
3.
Provide
copies
of
any
technical
information
and/
or
data
you
used
that
support
your
views.
4.
If
you
estimate
potential
burdens
or
costs,
explain
how
you
arrived
at
the
estimate
that
you
provide.
5.
Provide
specific
examples
to
illustrate
your
concerns.
6.
Offer
alternative
ways
to
improve
the
notice
or
collection
activity.
7.
Make
sure
to
submit
your
comments
by
the
deadline
in
this
document.
8.
To
ensure
proper
receipt
by
EPA,
be
sure
to
identify
the
docket
ID
number
assigned
to
this
action
in
the
subject
line
on
the
first
page
of
your
response.
You
may
also
provide
the
name,
date,
and
Federal
Register
citation.
II.
What
Action
is
the
Agency
Taking?
EPA
has
assessed
the
risks
associated
with
current
and
proposed
food
uses
of
metolachlor,
reassessed
81
existing
tolerances,
and
reached
a
tolerance
reassessment
and
risk
management
decision.
The
Agency
is
issuing
the
resulting
report
on
FQPA
Tolerance
Reassessment
Progress
and
Risk
Management
Decision
for
metolachlor,
known
as
a
TRED,
as
well
as
a
summary,
overview,
and
technical
support
documents.
EPA
must
review
tolerances
and
tolerance
exemptions
that
were
in
effect
when
FQPA
was
enacted
in
August
1996,
to
ensure
that
these
existing
pesticide
residue
limits
for
food
and
feed
commodities
meet
the
safety
standard
established
by
the
new
law.
Tolerances
are
considered
reassessed
once
the
safety
finding
has
been
made
or
a
revocation
occurs.
In
total,
81
tolerances
have
been
reassessed
and
are
now
considered
safe
under
section
408(
q)
of
FFDCA.
The
Agency
has
determined
that
there
are
no
dietary
(food
or
drinking
water)
or
aggregate
risks
of
concern
for
metolachlor,
so
mitigation
of
these
risks
is
not
necessary.
EPA
is
able
to
make
the
FQPA
safety
finding
for
all
current
and
proposed
uses
of
metolachlor.
EPA
must
consider
the
cumulative
effects
of
pesticides
that
have
common
mechanisms
of
toxicity,
and
may
issue
final
tolerance
reassessment
decisions
for
these
pesticides
only
after
their
cumulative
risks
have
been
considered.
The
Agency
has
examined
this
common
mechanism
potential
for
metolachlor
and
has
concluded
that
only
some
of
the
pesticides
that
comprise
the
class
of
chloroacetanilides
should
be
designated
as
a
``
Common
Mechanism
Group''
based
on
the
development
of
nasal
turbinate
tumors.
Because
only
acetochlor,
alachlor,
and
butachlor
should
be
grouped
based
on
a
common
mechanism
of
toxicity
for
nasal
turbinate
tumors,
a
cumulative
assessment
is
not
necessary
to
determine
whether
tolerances
established
for
residues
of
metolachlor
in/
on
RACs
are
reassessed
as
safe.
EPA
works
extensively
with
affected
parties
to
reach
the
tolerance
reassessment
decisions
presented
in
TREDs.
The
Agency
therefore
is
issuing
the
metolachlor
TRED
as
a
final
decision.
However,
the
docket
remains
open,
and
if
the
Agency
receives
any
comments
within
the
next
30
days
which
significantly
affect
the
Agency's
decision,
EPA
will
publish
an
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Federal
Register
/
Vol.
67,
No.
205
/
Wednesday,
October
23,
2002
/
Notices
amendment
to
the
TRED
in
the
Federal
Register.
In
the
absence
of
substantive
comments,
the
tolerance
reassessment
decisions
reflected
in
this
TRED
will
be
considered
final.
List
of
Subjects
Environmental
protection,
Pesticides
and
pests,
Metolachlor.
Dated:
October
2,
2002.
Lois
Ann
Rossi,
Director,
Special
Review
and
Reregistration
Division,
Office
of
Pesticide
Programs.
[FR
Doc.
02–
26578
Filed
10–
22–
02;
8:
45
am]
BILLING
CODE
6560–
50–
S
FEDERAL
COMMUNICATIONS
COMMISSION
Public
Information
Collections
Approved
by
Office
of
Management
and
Budget
October
11,
2002.
The
Federal
Communications
Commission
(FCC)
has
received
Office
of
Management
and
Budget
(OMB)
approval
for
the
following
public
information
collections
pursuant
to
the
Paperwork
Reduction
Act
of
1995,
Pub.
L.
104–
13.
An
agency
may
not
conduct
or
sponsor
and
a
person
is
not
required
to
respond
to
a
collection
of
information
unless
it
displays
a
currently
valid
control
number.
For
further
information
contact
A.
Marie
Moyd,
Federal
Communications
Commission,
(202)
418–
2111.
Federal
Communications
Commission
OMB
Control
No.:
3060–
0997.
Expiration
Date:
05/
31/
2005.
Title:
47
CFR
section
52.15(
k),
Numbering
Utilization
and
Compliance
Audit
Program.
Form
No.:
N/
A.
Respondents:
Business
or
other
forprofit
Estimated
Annual
Burden:
25
respondents;
33
per
response
(avg.);
825
total
annual
burden
hours
(for
all
collections
under
this
control
number).
Estimated
Annual
Reporting
and
Recordkeeping
Cost
Burden:
$0.
Frequency
of
Response:
On
occasion;
Third
Party
Disclosure.
Description
The
state
of
the
nation's
numbering
resources
has
a
direct
effect
on
the
growth
of
competition
in
the
telecommunications
industry.
The
nation's
numbering
resources
are
depleting
rapidly.
Under
the
Communications
Act
of
1934,
as
amended
by
the
Telecommunications
Act
of
1996,
Congress
granted
the
Federal
Communications
Commission
(Commission)
exclusive
jurisdiction
over
the
United
States'
portion
of
the
North
American
Numbering
Plan
(NANP).
See
47
U.
S.
C.
251(
e).
The
purpose
of
the
audits
is
to
monitor
telecommunications
carriers'
compliance
with
Commission's
numbering
rules
and
to
verify
the
accuracy
and
validity
of
the
numbering
data
submitted
to
the
Commission.
The
audits
will
also
allow
the
Commission
to
identify
inefficiencies
in
the
manner
in
which
carriers
use
numbers,
including
excessive
use
of
certain
categories
of
numbers
(e.
g.,
administrative,
aging,
or
intermediate
numbers).
By
ensuring
compliance
with
Commission
rules
that
promote
efficient
number
usage,
the
numbering
audits
will
help
preserve
the
nation's
numbering
resources.
The
Commission
staff
developed
a
standardized
audit
program
for
conducting
random
audits.
This
standard
audit
program
consists
of
audit
procedures,
an
internal
controls
questionnaire,
and
a
corresponding
data
request.
The
independent
auditor
would
conduct
audits
using
these
tools.
The
audit
procedures
generally
require
the
audited
carrier
to
respond
to
requests
for
information
from
the
independent
auditor.
The
internal
controls
questionnaire
and
the
data
request
require
audited
carriers
to
respond
to
specific
requests
for
information
during
the
audit.
The
independent
auditor
will
report
its
audit
findings
to
the
Commission.
The
Commission
staff
will
review
and
modify
the
audit
program
on
an
on
going
basis.
The
Commission
will
use
the
audit
results
to
determine
whether
the
audited
carriers
are
complying
with
the
Commission's
rules,
and
whether
the
audited
carriers'
numbering
data
submitted
to
the
Commission,
e.
g.,
FCC
Form
502,
is
accurate
and
valid.
To
the
extent
that
the
Commission
finds
evidence
of
potential
violations,
possible
enforcement
action
may
be
taken.
See
Second
Report
and
Order,
16
FCC
Rcd
at
349,
para.
96;
see
also
47
CFR
52.15(
k).
Obligation
to
respond:
Mandatory.
Public
reporting
burden
for
the
collections
of
information
are
as
noted
above.
Send
comments
regarding
the
burden
estimates
or
any
other
aspect
of
the
collections
of
information,
including
suggestions
for
reducing
the
burden
to
Performance
Evaluation
and
Records
Management,
Washington,
DC
20554.
Federal
Communications
Commission.
Marlene
Dortch,
Secretary.
[FR
Doc.
02–
26926
Filed
10–
22–
02;
8:
45
am]
BILLING
CODE
6712–
01–
P
FEDERAL
COMMUNICATIONS
COMMISSION
[CC
Docket
No.
94–
102;
DA
02–
2560]
Small
Business
Size
Standards
AGENCY:
Federal
Communications
Commission.
ACTION:
Notice;
comments
invited.
SUMMARY:
The
Commission
seeks
comment
on
a
proposed
special
small
business
size
standard
for
Tier
III
wireless
carriers
in
the
Enhanced
911
(E911)
proceeding.
This
action
is
taken
pursuant
to
a
requirement
in
the
Small
Business
Act.
DATES:
Comments
are
due
on
or
before
November
6,
2002,
and
reply
comments
are
due
on
or
before
November
21,
2002.
ADDRESSES:
Parties
who
choose
to
file
by
paper
must
file
an
original
and
four
copies
of
each
filing.
All
filings
must
be
addressed
to
the
Commission's
Secretary,
Marlene
H.
Dortch,
Office
of
the
Secretary,
Federal
Communications
Commission,
445
12th
Street,
SW.,
Washington,
DC
20554.
A
copy
should
also
be
sent
to
Jennifer
Tomchin,
Room
3C–
400,
Federal
Communications
Commission,
445
12th
Street,
SW.,
Washington,
DC
20554.
FOR
FURTHER
INFORMATION
CONTACT:
Jennifer
Tomchin,
Attorney,
202–
418–
1310.
SUPPLEMENTARY
INFORMATION:
1.
On
July
26,
2002,
the
Commission
adopted
an
Order
(E911
Small
Carriers
Order)
staying
certain
wireless
enhanced
911
(E911)
Phase
II
deployment
deadlines
for
Tier
II
and
Tier
III
carriers,
with
conditions.
(See
Order
to
Stay
in
CC
Docket
No.
94–
102,
FCC
02–
210,
released
July
26,
2002.)
Pursuant
to
this
Order,
Tier
II
carriers
were
defined
as
non
nationwide
carriers
that
had
over
500,000
subscribers
as
of
year
end
2001,
and
Tier
III
carriers
were
defined
as
all
other
non
nationwide
carriers.
In
the
E911
Small
Carriers
Order,
the
Commission
noted
that
it
would
solicit
public
comment
on
the
proposed
size
standard
for
Tier
III
carriers,
in
accordance
with
Section
121.902(
b)
of
the
SBA's
small
business
size
regulations.
The
Commission
now
seeks
comment
on
this
matter
for
purposes
of
obtaining
SBA
approval
of
the
Tier
III
size
standard.
This
action
will
not
affect
the
deadlines
or
conditions
set
forth
in
the
E911
Small
Carriers
Order,
including
applicable
reporting
requirements.
2.
In
the
E911
Small
Carriers
Order,
the
Commission
defined
Tier
II,
or
midsize
carriers,
as
those
non
nationwide
carriers
with
over
500,000
subscribers
as
of
year
end
2001.
The
Commission
VerDate
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15:
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22,
2002
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23OCN1
| epa | 2024-06-07T20:31:43.276686 | regulations | {
"license": "Public Domain",
"url": "https://downloads.regulations.gov/EPA-HQ-OPP-2002-0223-0001/content.txt"
} |
EPA-HQ-OPP-2002-0223-0020 | Supporting & Related Material | "2002-10-23T04:00:00" | null | UNITED
STATES
ENVIRONMENTAL
PROTECTION
AGENCY
WASHINGTON,
D.
C.
20460
OFFICE
OF
PREVENTION,
PESTICIDES
AND
TOXIC
SUBSTANCES
May
23,
2002
MEMORANDUM
SUBJECT:
Metolachlor.
Revised
HED
Science
Assessment
for
Tolerance
Reassessment
Eligibility
Decision.
PC
Code
108801.
DP
Barcode
D282964.
FROM:
Christina
Jarvis,
Risk
Assessor
Reregistration
Branch
II
Health
Effects
Division
(7509C)
THROUGH:
Alan
Nielsen,
Branch
Senior
Scientist
Reregistration
Branch
II
Health
Effects
Division
(7509C)
TO:
Anne
Overstreet,
Chemical
Review
Manager
Reregistration
Branch
III
Special
Review
and
Reregistration
Division
(7508W)
Attached
is
the
revised
tolerance
reassessment
eligibility
decision
document
for
metolachlor
and
s
metolachlor,
prepared
by
the
Health
Effects
Division
(HED).
This
assessment
has
been
revised
to
take
into
consideration
comments
made
by
Syngenta
Crop
Protection
during
the
30
day
registrant
comment
period.
HED
notes
that
no
changes
to
the
toxicological
endpoint
selection
have
been
made
in
this
revised
assessment,
nor
have
any
of
Syngenta's
comments
resulted
in
a
significant
change
to
the
risk
picture
for
metolachlor
and
s
metolachlor.
New
estimated
environmental
concentrations
of
metolachlor/
s
metolachlor
in
drinking
water
have
not
resulted
in
a
significant
change
to
the
aggregate
risk
assessment.
This
assessment
includes
the
hazard
characterization
from
Virginia
Dobozy,
residential
exposure
assessment
from
Richard
Griffin,
dietary
exposure
and
residue
chemistry
assessments
from
Sherrie
Kinard,
product
chemistry
from
Ken
Dockter,
drinking
water
assessment
from
Mark
Corbin,
and
aggregate
exposure
assessment
and
risk
characterization
from
Christina
Jarvis.
The
disciplinary
science
chapters
and
other
supporting
documents
referenced
in
this
document
are
as
follows:
°
Revised
Estimated
Drinking
Water
Concentrations
for
Metolachlor/
S
Metolachlor
and
its
Degradation
Products
for
Use
in
the
Human
Health
Drinking
Water
Risk
Assessment.
M.
Corbin,
05/
22/
02.
°
Product
Chemistry
Chapter
for
the
Tolerance
Reassessment
Eligibility
Decision
(TRED)
Document.
K.
Dockter,
2/
06/
02.
D274330.
°
Response
to
"SCAN
[only]
of
PMRA's
Review
of
Product
Chemistry.
K.
Dockter,
04/
19/
02.
D281758.
°
S
metolachlor.
Supplemental
Product
Chemistry
[Storage
Stability;
OPPTS
Guideline
No.
830.6317].
MRID
44183001
[Addendum
to
MRID
43928903].
K.
Dockter,
05/
22/
02.
D283040.
°
Report
of
the
Hazard
Identification
Assessment
Review
Committee.
V.
Dobozy,
9/
28/
01.
°
Results
of
the
HED
Metabolism
Assessment
Review
Committee
Meeting
Held
on
8/
14/
01.
V.
Dobozy;
8/
14/
01.
D274326.
°
Report
of
the
FQPA
Safety
Factor
Committee.
C.
Christensen;
11/
14/
01.
°
Revised
Metolachlor
and
S
Metolachlor
Residue
Chemistry
Chapter
for
the
Tolerance
Reassessment
Eligibility
Decision
(TRED)
Document.
S.
Kinard;
05/
22/
02.
D282931.
°
Revised
Toxicology
Chapter
for
Metolachlor/
S
Metolachlor.
V.
Dobozy,
05/
13/
02.
D282934.
°
Metolachlor.
Review
of
Six
Acute
Toxicity
Studies.
V.
Dobozy,
05/
21/
02.
D283039.
°
Revised
Metolachlor
and
S
Metolachlor.
Acute
and
Chronic
Dietary
Exposure
Assessments
for
the
Tolerance
Reassessment
Eligibility
Decision
(TRED).
S.
Kinard;
05/
22/
02.
D282933.
°
Metolachlor/
S
Metolachlor:
Residential
Risk
Assessment.
R.
Griffin,
2/
20/
02.
D274331.
°
Review
of
Metolachlor
Incident
Reports.
J.
Blondell
and
M.
Spann,
8/
15/
97.
D238112.
°
Replacement
of
Metolachlor
Technical
(Racemic
Metolachlor)
with
Alpha
Metolachlor
Technical;
Review
of
Bridging
Data.
L.
Kutney,
11/
12/
96.
D226780.
TABLE
OF
CONTENTS
1.
0
Executive
Summary......................................................................
2
2.
0
Physical/
Chemical
Properties
Characterization
.................................................
7
3.0
Hazard
Characterization
..................................................................
8
3.1
Hazard
Profile
...................................................................
8
3.
2
FQPA
Considerations
............................................................
12
3.3
Dose
Response
Assessment
.......................................................
12
3.4
Endocrine
Disruption
............................................................
18
4.0
Exposure
Assessment
and
Characterization
..................................................
18
4.
1
Summary
of
Registered
Uses
......................................................
18
4.2
Dietary
Exposure/
Risk
Pathway
....................................................
19
4.
2.
1
Residue
Profile
........................................................
19
4.2.2
Dietary
Exposure
.......................................................
23
4.
2.
2.
1
Acute
Dietary
Risk
Estimates.....................................
24
4.
2.
2.
2
Chronic
Dietary
Risk
Estimates
...................................
25
4.2.2.3
Cancer
Dietary
Exposure/
Risk
....................................
26
4.3
Water
Exposure/
Risk
Pathway
.....................................................
26
4.4
Residential
Exposure/
Risk
Pathway
.................................................
29
4.
4.
1
Home
Uses
............................................................
29
4.4.1.1
Residential
Handler
Exposure
.....................................
29
4.4.1.2
Residential
Postapplication
Exposure
...............................
30
4.
4.
2
Recreational
Uses.......................................................
31
4.
4.
3
Other
(Spray
Drift
etc.)...................................................
32
4.
5
Incidents
Reports.........................................................
32
5.
0
Aggregate
Risk
Assessments
and
Risk
Characterizations
.......................................
32
5.
1
Acute
Risk
....................................................................
32
5.
1.
1
Aggregate
Acute
Risk
Assessment
.........................................
32
5.
1.
2
Acute
DWLOC
Calculations..............................................
34
5.
2
Short
Term
Risk
................................................................
35
5.
2.
1
Aggregate
Short
Term
Risk
Assessment.....................................
35
5.
2.
2
Short
Term
DWLOC
Calculations..........................................
35
5.
3
Intermediate
Term
Risk
........................................................
37
5.
3.
1
Aggregate
Intermediate
Term
Risk
Assessment
...............................
37
5.
4
Chronic
Risk...................................................................
37
5.
4.
1
Aggregate
Chronic
Risk
Assessment
........................................
37
5.
4.
2
Chronic
DWLOC
Calculations.............................................
37
5.
5
Cancer
Risk
....................................................................
38
5.
5.
1
Aggregate
Cancer
Risk
Assessment
.........................................
38
6.
0
Cumulative............................................................................
38
7.
0
Data
Needs/
Label
Requirements...........................................................
39
2
Background
Metolachlor
is
a
chloroacetanilide
herbicide
that
was
first
registered
for
use
in
1976.
Racemic
metolachlor
consists
of
50%
each
of
the
R
enantiomer
(CGA
77101)
and
the
S
enantiomer
(CGA
77102,
or
alpha
metolachlor).
The
S
enantiomer
is
the
herbicidally
active
isomer.
In
1996,
the
registrant
(originally
Ciba
Geigy,
now
Syngenta)
proposed
a
process
to
produce
a
higher
ratio
of
CGA
77102:
CGA
77101
(88:
12
instead
of
50:
50)
and
applied
for
reduced
risk
status
based
on
similar
efficacy
at
decreased
application
rates
(the
application
rate
of
smetolachlor
is
approximately
36
percent
lower
than
that
of
metolachlor).
In
1997,
the
EPA
approved
the
registration
of
s
metolachlor
as
a
reduced
risk
product.
Syngenta
no
longer
holds
any
active
registrations
for
(racemic)
metolachlor
end
use
products;
however,
a
search
of
the
Agency's
REFS
system
on
5/
9/
2002
shows
that
there
is
a
registration
for
a
(racemic)
metolachlor
technical
product
that
is
still
held
by
Syngenta
(EPA
Reg.
No.
100
587).
Until
this
technical
registration
is
revoked,
the
Agency
will
proceed
with
a
tolerance
reassessment
decision
for
racemic
metolachlor,
based
on
all
crops
that
metolachlor
may
be
used
on,
as
allowed
for
by
the
technical
label.
The
Agency
notes,
however,
that
since
the
use
pattern
of
s
metolachlor
is
identical
to
that
of
racemic
metolachlor,
and
since
the
Agency
has
determined
that
s
metolachlor
has
either
comparable
or
decreased
toxicity
as
compared
to
racemic
metolachlor,
this
document
is
reflective
of
s
metolachlor
as
well.
1.0
Executive
Summary
The
Agency
has
conducted
a
revised
human
health
risk
assessment
for
the
active
ingredient
metolachlor
[2
chloro
N(
2
ethyl
6
methylphenyl)
N(
2
methoxy
1
methylethyl)
acetamide]
for
the
purpose
of
making
a
tolerance
reassessment
eligibility
decision.
Since
the
Reregistration
Eligibility
Decision
(RED)
document
for
metolachlor
was
completed
prior
to
the
passage
of
the
Food
Quality
Protection
Act
(FQPA)
of
1996,
a
tolerance
reassessment
eligibility
decision,
or
TRED,
is
now
required.
This
assessment
only
discusses
the
human
health
risk
assessment
required
for
reassessment
of
tolerances,
and
does
not
include
an
occupational
risk
assessment
required
for
reregistration
of
products.
As
noted
above,
this
TRED
for
metolachlor
is
also
representative
of
the
uses
of
s
metolachlor.
Usage
Information
Metolachlor
and
s
metolachlor
are
selective,
chloroacetanilide
herbicides
used
primarily
for
grassy
weed
control
in
many
agricultural
food
and
feed
crops;
residential
lawns;
commercial
turf
(including
golf
courses,
sports
fields,
recreation
areas,
and
sod
farms);
ornamental
plants,
trees,
and
shrubs,
and
vines;
hedge
rows;
and
horticultural
nurseries.
Corn,
sorghum,
and
soybeans
account
for
the
majority
of
the
use
of
both
metolachlor
and
s
metolachlor,
followed
by
cotton,
sweet
corn,
peanuts,
potatoes,
and
other
minor
field
and
vegetable
crops.
Application
rates
for
metolachlor
and
s
metolachlor
range
from
approximately
one
to
four
pounds
active
ingredient
(a.
i.)
per
acre.
Application
is
typically
made
preemergence,
one
time
per
season.
3
Syngenta
does
not
currently
hold
any
active
end
use
product
registrations
for
metolachlor.
Smetolachlor
is
registered
by
Syngenta
under
the
trade
names
of
Dual
MAGNUM
®
,
Pennant
MAGNUM
®
,
Bicep
MAGNUM
®
,
Boundary
®
,
and
Medal
®
.
S
metolachlor
is
formulated
mainly
as
an
emulsifiable
concentrate.
Other
formulations
include
flowable
concentrates,
granular,
and
ready
to
use
formulations.
Application
methods
for
agricultural
uses
includes
ground
application
(the
most
common
application
method),
aerial
application,
irrigation
systems,
and
chemigation
(center
pivot
only).
A
backpack
sprayer,
hose
end
sprayer,
or
handgun
application
may
be
used
by
professional
applicators
for
application
to
residential
lawns
or
turf.
Residential
applications
to
lawns
and
turf
are
intended
for
use
by
professional
applicators
only.
The
only
currently
active
lawn/
turf
label
is
an
emulsifiable
concentrate
formulation
for
s
metolachlor
(Pennant
MAGNUM
®
,
EPA
Reg.
No.
100
950).
Hazard
Identification
and
FQPA
Considerations
The
toxicology
database
for
metolachlor
is
complete
for
risk
assessment
purposes.
Metolachlor
is
moderately
acutely
toxic
(toxicity
category
III)
by
the
oral,
dermal,
and
inhalation
routes
of
exposure.
It
is
not
irritating
to
the
skin
or
eyes,
but
is
a
dermal
sensitizer.
The
Agency
notes
that
recently
reviewed
acute
toxicity
studies
from
1994
show
metolachlor
to
be
moderately
acutely
toxic
(toxicity
category
III)
by
the
oral
and
dermal
routes
of
exposure,
and
less
toxic
(toxicity
category
IV)
by
the
inhalation
route
of
exposure.
These
1994
studies
also
show
metolachlor
to
be
a
mild
eye
irritant
(toxicity
category
III)
and
a
minimal
skin
irritant
(toxicity
category
IV).
In
the
subchronic
and
chronic
toxicity
studies,
decreased
body
weight
and
body
weight
gain
were
the
most
commonly
observed
effects.
There
was
no
evidence
that
metolachlor
was
a
reproductive
or
developmental
toxicant.
No
systemic
toxicity
was
observed
when
metolachlor
was
administered
dermally
at
doses
up
to
1000
mg/
kg/
day.
There
was
no
evidence
of
mutagenic
or
cytogenetic
effects
in
vivo
or
in
vitro.
Metolachlor
has
been
classified
as
a
Group
C,
possible
human
carcinogen
based
on
liver
tumors
in
rats
at
the
highest
dose
tested.
A
linear
risk
assessment
is
not
required.
The
toxicology
database
for
s
metolachlor,
when
bridged
with
the
metolachlor
database,
is
complete
for
risk
assessment
purposes.
Bridging
toxicology
data
from
metolachlor,
including
acute
toxicity,
subchronic
toxicity
in
rat
and
dog,
developmental
toxicity
in
rat
and
rabbit,
mutagenicity,
and
metabolism
studies
are
available.
S
metolachlor
is
moderately
acutely
toxic
(toxicity
category
III)
by
the
oral
and
dermal
route
and
relatively
non
toxic
(toxicity
category
IV)
by
the
inhalation
route
of
exposure.
It
causes
slight
eye
irritation,
and
is
non
irritating
dermally
but
is
a
dermal
sensitizer.
In
the
subchronic
studies,
body
weight
and
body
weight
gain
decreases
were
the
most
commonly
observed
effects.
There
was
no
evidence
that
s
metolachlor
was
a
developmental
toxicant.
There
was
no
evidence
of
mutagenic
or
cytogenetic
effects
in
vivo
or
in
vitro
with
s
metolachlor.
Tolerances
are
established
for
the
combined
residues
(free
and
bound)
of
metolachlor
and
its
metabolites,
determined
as
the
derivatives
2[(
2
ethyl
6
methylphenyl)
amino]
1
propanol
CGA37913
and
4(
2
ethyl
6
methylphenyl)
2
hydroxy
5
methyl
3
morpholinone
(CGA
49751),
each
expressed
as
the
parent
compound,
in
or
on
raw
agricultural
commodities
(40
CFR
§180.368).
The
Metabolism
Assessment
Review
Committee
(MARC)
determined
that
the
4
residues
of
concern
for
plant
and
animal
commodities
are
metolachlor
and
its
metabolites,
determined
as
the
derivatives
CGA
37913
and
CGA
49751.
Metabolites
of
metolachlor
are
assumed
to
be
toxicologically
equivalent
to
parent
metolachlor.
The
residues
of
concern
for
smetolachlor
are
the
same
as
those
for
metolachlor
(L.
Kutney
memo,
11/
12/
96).
Based
on
the
Hazard
Identification
Assessment
Review
Committee
(HIARC)
decision
that
metolachlor
and
s
metolachlor
are
of
comparable
toxicity,
studies
of
either
chemical
were
used
interchangeably
for
toxicology
endpoint
selection.
Toxicological
endpoints
selected
for
risk
assessment
purposes
are
based
on
clinical
signs
of
toxicity
and
decreased
body
weight
gain.
No
evidence
of
neurotoxicity
or
neuropathology
was
seen
in
any
of
the
available
studies.
A
developmental
neurotoxicity
study
is
not
required
for
metolachlor.
Dermal
absorption
is
calculated
to
be
58%,
based
on
a
dermal
absorption
study
in
rats,
and
inhalation
absorption
is
assumed
to
be
100%.
In
the
case
of
metolachlor/
s
metolachlor,
risk
assessments
were
conducted
for
the
specific
exposure
scenarios
listed
below.
Short
and
intermediate
term
dermal
risk
assessments
were
not
conducted
as
no
systemic
toxicity
was
seen
at
the
limit
dose
of
1000
mg/
kg/
day.
The
reference
dose
(RfD)
is
equal
to
the
No
Observed
Adverse
Effect
Level,
or
NOAEL,
divided
by
the
100X
uncertainty
factor.
–
acute
dietary(
general
population):
NOAEL=
300
mg/
kg/
day
RfD=
3.0
mg/
kg/
day
–
chronic
dietary:
NOAEL=
9.7
mg/
kg/
day
RfD
=
0.1
mg/
kg/
day
–
short
term
incidental
oral:
NOAEL=
50
mg/
kg/
day
Target
MOE=
100
A
total
uncertainty
factor
(UF)
of
100X
was
applied
to
the
risk
assessment
to
account
for
interspecies
extrapolation
(10X)
and
intraspecies
variability
(10X).
The
FQPA
Safety
Factor
Committee
has
concluded
that
the
FQPA
safety
factor
for
the
protection
of
infants
and
children
may
be
reduced
to
1X
(i.
e.,
removed)
for
the
dietary
and
residential
risk
assessments.
Dietary
Exposure
An
upper
end
Tier
1
acute
dietary
risk
assessment
was
conducted
for
combined
exposure
to
residues
of
metolachlor
and
s
metolachlor
found
on
various
field
and
vegetable
crops.
The
assessment
used
tolerance
level
residues
values
and
assumed
that
100%
of
labeled
crops
were
treated
with
metolachlor/
s
metolachlor.
Since
it
is
not
possible
to
distinguish
between
residues
of
metolachlor
and
s
metolachlor
using
currently
available
enforcement
methods,
and
since
the
tolerances
for
metolachlor
presently
cover
residues
resulting
from
the
use
of
s
metolachlor,
acute
dietary
risk
estimates
are
applicable
to
both
metolachlor
and
s
metolachlor.
Acute
dietary
risk
estimates
are
not
of
concern
(i.
e.,
below
100%
of
the
acute
population
adjusted
dose,
or
aPAD)
at
the
95
th
exposure
percentile,
for
any
population
subgroup.
An
upper
end
Tier
1
chronic
dietary
risk
assessment
was
also
conducted
for
combined
exposures
to
metolachlor
and
s
metolachlor.
Tolerance
level
residue
values
and
100%
crop
treated
were
assumed.
As
with
the
acute
dietary
risk
assessment,
chronic
dietary
risk
estimates
are
applicable
to
both
metolachlor
and
s
metolachlor.
Chronic
dietary
risk
estimates
are
not
of
concern
(i.
e.,
5
below
100%
of
the
chronic
population
adjusted
dose,
or
cPAD)
for
any
population
subgroup.
The
Agency
notes
that
the
Tier
1
acute
and
chronic
dietary
assessments
could
be
further
refined
using
available
percent
crop
treated
information,
field
trial
and
monitoring
data,
and
processing
factors;
however,
the
estimated
acute
and
chronic
dietary
risks
are
not
of
concern
for
any
population
subgroup.
Further
refinements
are
not
warranted
at
this
time.
A
separate
cancer
dietary
risk
assessment
was
not
conducted,
as
it
was
determined
that
the
chronic
dietary
endpoint
would
be
protective
of
any
cancer
dietary
risks.
In
conjunction
with
a
March
22,
2002
Federal
Register
notice
that
cancelled
the
existing
use
of
metolachlor
on
stone
fruits
and
almonds,
stone
fruits
have
been
removed
from
this
revised
risk
assessment.
Almonds
will
remain
in
the
dietary
assessment,
as
there
is
a
crop
group
tolerance
that
exists
for
tree
nuts,
and
almonds
are
part
of
the
tree
nut
crop
group.
The
Agency
has
agreed
to
include
sunflower,
sugar
beets,
tomatoes,
spinach,
and
grass
grown
for
seed
in
the
tolerance
reassessment.
The
residue
chemistry
data
for
sunflower
and
sugar
beets
are
currently
under
review;
however,
a
decision
on
permanent
tolerances
for
these
commodities
cannot
be
made
until
an
occupational
assessment
has
been
conducted.
Residue
chemistry
data
support
permanent
tolerances
for
tomatoes,
spinach,
and
grass
grown
for
seed.
However,
a
permanent
tolerance
may
not
be
granted
until
a
full
occupational
assessment
has
been
conducted.
Since
this
is
a
tolerance
reassessment
document
and
not
a
reregistration
eligibility
decision
document,
an
occupational
assessment
will
not
be
done
as
part
of
this
document.
Asparagus,
carrots,
Swiss
chard,
all
peppers,
horseradish,
and
rhubarb
are
pending
tolerances
that
will
be
reviewed
by
the
Agency's
Registration
Division
at
a
future
date
and
will
not
be
included
in
the
tolerance
reassessment
eligibility
decision
document.
Residential
Exposure
Syngenta
has
no
remaining
residential
end
use
product
labels
for
racemic
metolachlor.
Smetolachlor
may
be
applied
as
an
emulsifiable
concentrate
to
residential
lawns
or
turf
by
a
professional
applicator
only.
Therefore,
residential
handlers
are
not
expected
to
be
exposed
to
residues
of
s
metolachlor.
A
residential
handler
risk
assessment
was
not
conducted.
There
is
a
potential
for
residential
postapplication
exposure
to
residues
of
s
metolachlor
that
may
remain
on
lawns
after
treatment
by
professional
applicators.
However,
no
short
and
intermediate
term
dermal
endpoints
were
selected
(there
was
no
systemic
toxicity
seen
at
the
limit
dose
of
1000
mg/
kg/
day)
and
inhalation
exposure
is
expected
to
be
minimal
as
labels
specify
that
residents
should
not
enter
treated
areas
until
after
sprays
have
dried.
Therefore,
the
only
residential
postapplication
scenarios
that
were
assessed
were
potential
oral
exposure
to
children
from
contact
with
treated
lawn
and
soil
(i.
e.,
object
to
mouth,
hand
to
mouth,
and
incidental
soil
ingestion
scenarios).
These
exposure
scenarios
are
considered
short
term
in
duration
(one
to
30
days
of
exposure),
based
on
label
specifications
of
a
six
week
interval
before
the
re
application
of
s
metolachlor.
The
registrant
has
also
indicated
a
label
revision
to
limit
application
to
one
application
per
season.
6
Postapplication
oral
risk
estimates
are
based
on
a
single
application
of
s
metolachlor
at
the
maximum
label
rate
of
2.47
lb
ai/
acre
(EPA
Reg.
No.
100
950).
The
exposure
values
of
the
three
scenarios
(object
to
mouth,
hand
to
mouth,
and
incidental
soil
ingestion)
were
combined
to
establish
the
possible,
if
not
likely,
upper
end
estimate
of
oral
exposure
to
children
from
lawn
(or
similar)
use.
Combined
oral
MOE
estimates
are
1100
for
s
metolachlor.
Postapplication
oral
exposure
from
s
metolachlor
is
not
of
concern.
The
Agency
acknowledges
that
Syngenta
has
no
remaining
residential
end
use
product
labels
for
racemic
metolachlor;
however,
for
informational
purposes,
the
combined
oral
MOE
estimates
for
metolachlor
(based
on
EPA
Reg.
No.
100
691
and
a
maximum
label
application
rate
of
4
lb
ai/
acre)
are
670
and
not
of
concern.
Drinking
Water
Exposure
A
drinking
water
assessment
was
conducted
based
on
monitoring
data
from
several
sources,
as
well
as
on
Tier
1
FIRST
and
SCI
GROW
modeling
results.
It
is
important
to
note
that
the
analytical
methods
used
in
the
drinking
water
assessment
are
not
able
to
distinguish
between
metolachlor
and
s
metolachlor;
therefore,
the
estimated
environmental
concentrations
(EECs)
presented
in
this
risk
assessment
are
representative
of
both
racemic
metolachlor
and
s
metolachlor.
EECs
for
metolachlor
and
s
metolachlor
were
calculated
for
both
the
parent
compound
and
the
ethanesulfonic
acid
(ESA)
and
oxanilic
acid
(OA)
degradates.
Although
it
was
determined
by
the
Metabolism
Assessment
Review
Committee
that
the
ESA
and
OA
metabolites
appear
to
be
less
toxic
than
parent
metolachlor,
they
are
included
in
the
risk
assessment
since
they
were
found
in
greater
abundance
than
the
parent
in
water
monitoring
studies.
Revised
surface
water
EEC
values
for
parent
metolachlor/
s
metolachlor
range
from
4.3
ppb
(chronic)
to
77.6
ppb
(acute)
in
monitoring
data.
The
ground
water
EEC
value
for
parent
metolachlor/
s
metolachlor
is
5.5
ppb,
based
on
modeled
estimates.
The
EEC
values
of
the
ESA
and
OA
degradates
range
from
22.8
ppb
to
91.4
ppb
in
surface
water,
and
from
31.7
ppb
to
65.8
ppb
in
ground
water,
based
on
modeled
estimates.
These
values
are
all
below
the
Agency's
estimated
drinking
water
levels
of
comparison
(DWLOCs),
and
therefore
do
not
pose
an
unreasonable
risk
of
concern
to
human
health.
Aggregate
Exposure
Aggregate
risk
assessments
for
metolachlor/
s
metolachlor
consider
the
combined
risk
from
exposure
to
residues
via
the
food,
drinking
water,
and
residential
pathways
of
exposure.
In
the
case
of
metolachlor/
s
metolachlor,
food,
drinking
water,
and
postapplication
oral
exposure
to
children
(post
application
oral
exposure
values
are
from
the
use
of
s
metolachlor
only)
will
be
considered
in
the
aggregate
assessment.
The
acute
aggregate
risk
assessment
is
based
on
combined
exposure
to
food
and
drinking
water
only,
and
is
not
of
concern.
The
short
term
aggregate
risk
assessment
is
based
on
food,
drinking
water,
and
short
term
postapplication
oral
exposure
to
children
(s
metolachlor
only).
Short
term
aggregate
risks
are
not
of
concern.
The
chronic
aggregate
risk
assessment
is
based
on
food
and
drinking
water
exposure
only,
as
there
are
no
long
term
postapplication
exposure
scenarios.
Chronic
aggregate
risks
are
not
of
concern.
7
Occupational
Exposure
Occupational
exposures
and
risks
are
not
considered
under
FQPA;
therefore,
an
occupational
risk
assessment
is
not
included
in
this
FQPA
tolerance
reassessment
document.
Data
Needs
Toxicology
data
gaps
for
metolachlor
and
s
metolachlor
include
a
28
day
inhalation
study
in
rats.
Submission
of
these
studies
would
allow
the
Agency
to
improve
characterization
regarding
the
concern
for
toxicity
via
the
inhalation
route
of
exposure.
Registrants
are
recommended
to
follow
the
protocol
for
the
90
day
inhalation
study
provided
in
OPPTS
Guideline
870.3465,
but
cease
exposure
at
28
days.
Numerous
residue
chemistry
data
gaps,
as
well
as
several
product
chemistry
data
gaps,
have
been
identified
for
metolachlor
and/
or
s
metolachlor.
These
are
identified
in
Section
7.0
of
this
document.
2.0
Physical/
Chemical
Properties
Characterization
Metolachlor
[2
chloro
N(
2
ethyl
6
methylphenyl)
N(
2
methoxy
1
methylphenyl)
acetamide],
a
List
A
chemical,
and
its
enriched
isomer
s
metolachlor
are
registered
for
selective
weed
control
in
many
field
and
vegetable
crops,
ornamentals,
lawns,
and
turf.
Metolachlor
is
a
pale
yellow
to
light
brown
liquid
with
a
boiling
point
of
334
C;
density
of
1.117
g/
cm
3
at
20
C;
log
Pow
of
3.05
at
25
C;
and
a
low
vapor
pressure
of
2.8
x
10
5
mm
Hg
at
25
C.
Metolachlor
is
completely
miscible
in
n
hexane,
methanol,
acetone,
toluene,
and
n
octanol
at
25
C.
No
impurities
of
toxicological
concern
have
been
identified
for
metolachlor
or
s
metolachlor.
Product
chemistry
data
requirements
are
essentially
complete
for
both
metolachlor
and
smetolachlor
Any
product
chemistry
data
gaps
that
have
been
identified
in
the
product
chemistry
chapter
are
listed
in
Section
7.0
of
this
document
(K.
Dockter
memo,
2/
06/
02;
revised
by
K.
Dockter
memo,
4/
19/
02).
Empirical
formula:
C15
H22
NO2
Cl
Molecular
weight:
283.8
CAS
Registry
Nos.:
51218
45
2
and
87392
12
9
PC
Codes:
108801
&
108800
8
N
O
O
Cl
3.0
Hazard
Characterization
3.1
Hazard
Profile
Metolachlor:
The
metolachlor
toxicology
database
is
complete
for
risk
assessment
purposes.
Metolachlor
is
moderately
acutely
toxic
(toxicity
category
III)
by
the
oral,
dermal,
and
inhalation
routes
of
exposure.
It
is
not
irritating
to
the
skin
or
eyes,
but
is
a
dermal
sensitizer.
The
Agency
notes
that
recently
reviewed
acute
toxicity
studies
from
1994
show
metolachlor
to
be
moderately
acutely
toxic
(toxicity
category
III)
by
the
oral
and
dermal
routes
of
exposure,
and
less
toxic
(toxicity
category
IV)
by
the
inhalation
route
of
exposure.
These
1994
studies
also
show
metolachlor
to
be
a
mild
eye
irritant
(toxicity
category
III)
and
a
minimal
skin
irritant
(toxicity
category
IV).
In
the
subchronic
oral
studies,
the
only
evidence
of
toxicity
was
decreased
body
weight/
body
weight
gain
at
259
mg/
kg/
day
in
female
rats
and
at
29
mg/
kg/
day
in
male
and
female
dogs.
The
respective
No
Observed
Adverse
Effect
Levels
(NOAELs)
for
these
studies
were
23
mg/
kg/
day
and
9
mg/
kg/
day.
There
was
no
evidence
of
systemic
toxicity
when
1000
mg/
kg/
day
was
applied
topically
to
rabbits.
Dermal
irritation
was
observed
at
10
mg/
kg/
day
and
above.
Similar
effects
were
seen
after
long
term
administration
of
metolachlor.
In
the
chronic
dog
study,
the
only
adverse
effect
was
decreased
body
weight
gain
in
females
at
33
mg/
kg/
day;
the
NOAEL
was
10
mg/
kg/
day.
In
the
mouse
carcinogenicity
study,
possible
treatment
related
deaths
in
females
and
decreased
body
weight/
body
weight
gain
in
both
sexes
were
observed
at
450
mg/
kg/
day;
the
NOAEL
was
150
mg/
kg/
day.
In
the
rat
combined
chronic
toxicity/
carcinogenicity
study,
decreased
body
weight
gain
and
food
consumption
were
observed
at
150
mg/
kg/
day;
the
NOAEL
was
15
mg/
kg/
day.
There
was
no
evidence
of
carcinogenicity
in
mice;
however,
there
were
statistically
significant
increases
in
liver
adenomas
and
combined
adenomas/
carcinomas
in
female
rats.
In
male
rats,
there
was
a
statistically
significant
trend
but
not
pair
wise
significance
for
liver
tumors.
There
was
no
evidence
of
a
mutagenic
or
cytogenetic
effects
in
vivo
or
in
vitro.
HED's
Cancer
Assessment
Review
Committee
has
classified
metolachlor
as
a
Group
C
carcinogen
with
risk
quantitated
using
a
non
linear
approach.
The
NOAEL
of
15
mg/
kg/
day
from
the
rat
combined
chronic
toxicity/
carcinogenicity
study
is
based
on
neoplastic
9
nodules/
hepatocellular
carcinomas
seen
at
the
highest
dose
tested
of
150
mg/
kg/
day.
The
Agency
notes
that
the
tumor
NOAEL
of
15
mg/
kg/
day
is
comparable
to
the
NOAEL
of
9.7
mg/
kg/
day
selected
for
establishing
the
chronic
reference
dose
for
metolachlor.
The
recommendation
for
a
non
linear
approach
should
be
followed
since
no
new
data
were
submitted
for
a
re
evaluation
by
the
Cancer
Assessment
Review
Committee.
The
prenatal
developmental
studies
in
the
rat
and
rabbit
revealed
no
evidence
of
a
qualitative
or
quantitative
susceptibility
in
fetal
animals.
In
the
rabbit
prenatal
developmental
toxicity
study,
at
360
mg/
kg/
day,
maternal
animals
had
persistent
anorexia
and
decreased
body
weight
gain;
the
NOAEL
was
120
mg/
kg/
day.
In
the
rat
prenatal
developmental
toxicity
study,
frank
toxicity
[death,
clinical
signs
(clonic
and/
or
tonic
convulsions,
excessive
salivation,
urine
stained
abdominal
fur
and/
or
excessive
salivation)
and
decreased
body
weight
gain]
was
observed
at
the
limit
dose
of
1000
mg/
kg/
day
in
maternal
animals;
the
NOAEL
was
300
mg/
kg/
day.
The
developmental
effects
at
1000
mg/
kg/
day
included
slightly
decreased
number
of
implantations
per
dam,
decreased
number
of
live
fetuses/
dam,
increased
number
of
resorptions/
dam
and
significant
decrease
in
mean
fetal
body
weight.
In
the
two
generation
reproduction
study
in
rats,
there
was
no
evidence
of
parental
or
reproductive
toxicity
at
approximately
80
mg/
kg/
day,
the
highest
dose
tested.
At
this
dose,
there
was
a
minor
decrease
in
fetal
body
weight
beginning
at
lactation
day
4;
the
NOAEL
was
approximately
25
mg/
kg/
day.
Since
a
similar
body
weight
decrease
was
not
seen
on
lactation
day
zero,
the
cause
of
the
effect
on
later
lactation
days
is
most
likely
due
to
exposure
of
the
pups
to
metolachlor
in
the
diet
and/
or
milk
and
therefore
is
not
evidence
of
an
increased
quantitative
susceptibility
in
post
natal
animals.
A
series
of
acute,
subchronic,
developmental
(rat)
and
mutagenicity
studies
were
conducted
on
the
ethane
sulfonic
acid
(ESA,
or
CGA
354743)
and
oxanilic
acid
(OA,
or
CGA
51202)
metabolites
found
in
water.
The
MARC
concluded
that
the
ESA
and
OA
metabolites
appear
to
be
less
toxic
than
parent
metolachlor/
s
metolachlor,
based
on
subchronic
studies
in
the
rat
and
dog
(ESA
metabolite
only)
and
developmental
studies
in
the
rat.
No
toxicity
was
observed
in
any
of
these
studies
at
the
limit
dose(
s)
of
1000
mg/
kg/
day
or
greater.
Since
a
dose
for
toxicity
of
the
metabolites
was
not
demonstrated,
the
degree
of
difference
between
metabolite
and
parent
could
not
be
established.
Acute
toxicity
was
essentially
comparable,
except
both
metabolites
were
moderate
(ESA)
or
severe
(OA)
eye
irritants,
whereas
the
parent
compounds
were
not.
However,
the
MARC
concluded
that
the
ESA
and
OA
metabolites
should
be
included
in
the
water
risk
assessment
since
they
were
found
in
greater
abundance
than
the
parent(
s)
in
water
monitoring
studies.
In
addition,
parent
metolachlor
has
been
classified
as
a
Group
C
carcinogen.
Without
long
term
studies
in
rats
and
mice
with
the
metabolites,
there
are
no
data
to
substantiate
that
the
metabolites
are
not
carcinogenic.
One
data
gap
exists
for
metolachlor,
as
there
is
concern
for
toxicity
by
the
inhalation
route
following
exposure
on
multiple
days
in
a
commercial
setting.
A
28
day
inhalation
study
in
rats
with
metolachlor
should
be
conducted.
Registrants
are
recommended
to
follow
the
protocol
provided
in
OPPTS
Guideline
870.3465
(90
day
inhalation
study)
but
cease
exposure
at
28
days.
The
acute
toxicity
profile
for
metolachlor
is
presented
in
Table
1a.
For
comparison
purposes,
the
10
acute
toxicity
profile
for
metolachlor,
based
on
the
recently
reviewed
1994
acute
toxicity
studies,
is
presented
in
Table
1b.
Table
1a:
Acute
Toxicity
Profile
of
Metolachlor
(PC
Code
108801)
Guideline
No.
Study
Type
MRIDs
#
Results
Toxicity
Category
870.1100
Acute
Oral
Rats
00015523
LD50
=
2780
mg/
kg
III
870.1200
Acute
Dermal
Rabbit
00015526
LD50
=
>
10
mg/
kg
III
870.1300
Acute
Inhalation
Rats
00015535
LD50
=
>
1.75
mg/
L
III
870.2400
Primary
Eye
Irritation
Rabbits
00015528
non
irritating
IV
870.2500
Primary
Skin
IrritationRabbits
00015530
non
irritating
IV
870.2600
Dermal
Sensitization
Guinea
pigs
00015631
positive
870.6200
Acute
Neurotoxicity–
NA
NA–
study
not
required
Table
1b:
Acute
Toxicity
Profile
of
Metolachlor
(PC
Code
108801)
Based
on
1994
Studies
OPPTS
Guideline
No.
Study
Type
MRIDs
#
Results
Toxicity
Category
870.1100
Acute
Oral
Rat
43492001
LD50
=
3302
mg/
kg
(males);
2000
mg/
kg
(females);
2877
mg/
kg
(combined
sexes)
III
870.1200
Acute
Dermal
Rabbit
43492002
LD50
=
>
2000mg/
kg
III
870.1300
Acute
Inhalation
Rat
43492003
LC50
=
>
4.33
mg/
L
IV
870.2400
Primary
Eye
Irritation
Rabbit
43492004
mild
irritant
III
870.2500
Primary
Skin
Irritation
Rabbit
43492005
minimal
irritant
IV
870.2600
Dermal
Sensitization
guinea
pig
43492006
positive
S
Metolachlor:
The
toxicology
database
for
s
metolachlor,
when
bridged
with
the
metolachlor
database,
is
complete
for
risk
assessment
purposes.
Bridging
toxicology
data,
including
acute
toxicity,
subchronic
toxicity
in
the
rat
and
dog,
developmental
toxicity
in
the
rat
and
rabbit,
mutagenicity,
and
metabolism
studies
are
available.
S
metolachlor
is
moderately
acutely
toxic
(Toxicity
Category
III)
by
the
oral
and
dermal
routes
of
exposure
and
relatively
non
toxic
(Toxicity
Category
IV)
by
the
inhalation
route
of
exposure.
S
metolachlor
causes
slight
eye
irritation
and
is
non
irritating
dermally,
but
is
a
dermal
sensitizer.
In
one
subchronic
toxicity
study
in
rodents
with
s
metolachlor,
no
effects
were
observed
in
male
11
and
female
rats
at
the
high
dose
of
approximately
225
mg/
kg/
day.
In
another
subchronic
toxicity
study
in
rats,
decreased
body
weight/
body
weight
gain,
reduced
food
consumption
and
food
efficiency
and
increased
kidney
weights
in
males
were
observed
at
150
mg/
kg/
day;
the
NOAEL
was
15
mg/
kg/
day.
In
the
subchronic
dog
study,
no
effects
were
observed
in
dogs
at
the
high
dose
of
approximately
70
mg/
kg/
day.
There
was
no
evidence
of
increased
quantitative
or
qualitative
fetal
susceptibility
in
the
prenatal
developmental
studies
in
rats
and
rabbits.
In
the
rat,
maternal
toxicity
[increased
clinical
signs
of
toxicity
(pushing
head
through
bedding)
and
decreased
body
weights/
body
weight
gains,
food
consumption
and
food
efficiency]
was
observed
at
500
mg/
kg/
day;
the
NOAEL
was
50
mg/
kg/
day.
There
were
no
developmental
effects
at
1000
mg/
kg/
day,
the
highest
dose
tested.
In
the
rabbit,
clinical
signs
of
toxicity
(little/
none/
soft
stool)
were
observed
at
100
mg/
kg/
day;
the
NOAEL
was
20
mg/
kg/
day.
No
developmental
effects
were
observed
at
500
mg/
kg/
day,
the
highest
dose
tested.
There
was
no
evidence
of
a
mutagenic
or
cytogenic
in
vitro
or
in
vivo
studies
with
s
metolachlor.
S
metolachlor
is
extensively
absorbed
and
metabolized
following
oral
administration.
Elimination
is
via
the
urine
and
feces.
Tissue
residues
were
highest
in
whole
blood.
Metabolism
studies
were
inadequate
for
comparing
the
metabolic
pathways
of
metolachlor
and
smetolachlor
However,
based
on
a
comparison
of
the
findings
in
the
available
studies
with
both
chemicals,
it
appears
that
s
metolachlor
is
of
comparable
toxicity
to
the
racemic
mixture
(metolachlor).
One
data
gap
exists
for
s
metolachlor,
as
there
is
concern
for
toxicity
by
the
inhalation
route
following
exposure
on
multiple
days
in
a
commercial
setting.
A
28
day
inhalation
study
in
rats
with
s
metolachlor
should
be
conducted.
The
registrant
is
recommended
to
follow
the
protocol
provided
in
OPPTS
Guideline
870.3465
(90
day
inhalation
study)
but
cease
exposure
at
28
days.
The
acute
toxicity
profile
for
s
metolachlor
is
presented
in
Table
1c:
12
Table
1c:
Acute
Toxicity
Profile
of
S
Metolachlor
(PC
Code
108800)
Guideline
No.
Study
Type
MRIDs
#
Results
Toxicity
Category
870.1100
Acute
Oral
Rats
43928915
LD50
=
3267
mg/
kg
(
%
);
2577
mg/
kg/
day
(
&
);
2672
mg/
kg/
day
(combined)
III
870.1200
Acute
Dermal
Rabbit
43928916
LD50
=
>
2000
mg/
kg
III
870.1300
Acute
Inhalation
Rats
43928917
LD50
=
>
2.91
mg/
L
IV
870.2400
Primary
Eye
Irritation
Rabbits
43928918
slight
to
moderate
conjunctival
irritation
that
cleared
in
48
hours
III
870.2500
Primary
Skin
IrritationRabbits
43928919
non
irritating
IV
870.2600
Dermal
Sensitization
Guinea
pigs
43928920
positive
870.6200
Acute
Neurotoxicity–
NA
NA–
study
not
required
3.2
FQPA
Considerations
The
FQPA
Safety
Factor
Committee
met
on
November
5,
2001
to
evaluate
the
hazard
and
exposure
data
for
metolachlor
and
s
metolachlor,
and
recommended
that
the
FQPA
Safety
Factor
for
the
protection
of
infants
and
children
be
reduced
to
1x
(removed)
for
the
following
reasons
(Memorandum:
Report
of
the
FQPA
Safety
Factor
Committee,
Carol
Christensen,
11/
14/
01):
i.
The
toxicology
database
is
complete
for
the
FQPA
assessment;
ii.
There
is
no
indication
of
quantitative
or
qualitative
increased
susceptibility
of
rats
or
rabbits
to
in
utero
and/
or
postnatal
exposure
to
metolachlor
in
the
available
toxicity
data;
iii.
A
developmental
neurotoxicity
study
is
not
required
for
metolachlor;
iv.
The
dietary
(food
and
drinking
water)
and
non
dietary
exposure
(residential)
assessments
will
not
underestimate
the
potential
exposures
for
infants
and
children
from
the
use
of
metolachlor.
3.3
Dose
Response
Assessment
Background:
Metolachlor
(CGA
24705)
consists
of
50%
each
of
the
R
enantiomer
(CGA
77101)
and
the
S
13
enantiomer
(CGA
77102,
also
referred
to
as
alpha
metolachlor).
CGA
77102
is
the
isomer
that
is
responsible
for
the
herbicidal
activity
of
metolachlor.
The
registrant
developed
a
process
to
produce
a
higher
ratio
of
CGA
77102:
CGA
77101
(88:
12)
and
applied
for
reduced
risk
status
based
on
decreased
application
rates
in
1996.
To
support
the
registration
of
s
metolachlor,
bridging
toxicology
data
were
submitted,
including
the
following
studies:
six
acute
toxicity,
subchronic
toxicity
in
rat
and
dog,
developmental
toxicity
in
rat
and
rabbit
and
three
mutagenicity
studies.
The
registrant
made
the
argument
that
CGA
77102
was
already
tested
as
part
of
the
racemate.
Based
on
the
additional
studies
with
CGA
77102,
the
quantitative
doseeffect
relationship
of
the
racemate
and
the
S
enantiomer
were
very
similar.
The
HED
RfD
Peer
Review
Committee
met
on
April
10,
1997
to
determine
whether
the
limited
toxicological
data
were
adequate
to
demonstrate
that
both
s
metolachlor
and
metolachlor
have
identical
properties
and
if
so,
the
applicability
of
the
data
base
for
metolachlor
in
the
safety
evaluation
of
smetolachlor
and
whether
a
separate
RfD
was
required.
The
Committee
concluded
that,
without
metabolism
studies
and
side
by
side
subchronic
studies
conducted
in
the
same
strain
of
rat
using
comparable
dose
levels
of
test
materials,
the
identification
of
any
qualitative
or
quantitative
differences
in
the
toxicological
properties
of
CGA
77012
and
metolachlor
was
not
possible.
The
data
(metabolism
and
subchronic
toxicity
studies)
requested
by
the
1997
RfD
Committee
were
submitted
and
reviewed.
On
August
14,
2001,
the
HED's
Metabolism
Assessment
Review
Committee
met
to
determine
if
there
is
comparable
metabolism
of
metolachlor
and
smetolachlor
The
MARC
concluded
that
there
are
some
deficiencies
in
the
metabolism
databases
for
metolachlor
and
s
metolachlor
that
prohibit
a
definitive
conclusion
about
the
comparable
metabolism
of
the
two
chemicals.
First,
the
study
(MRID
44491402)
in
which
there
were
side
byside
metabolic
assays
was
conducted
with
only
a
single
oral
dose
(0.5
mg/
kg).
Therefore,
there
are
no
data
on
high
dose
or
repeated
low
dose
metabolism
under
the
same
study
conditions.
Second,
a
metabolic
pathway
was
proposed
for
metolachlor
(MRID
43164201)
but
not
s
metolachlor.
Third,
most
of
the
metabolites
of
both
metolachlor
and
s
metolachlor
have
not
been
identified.
The
MARC
concluded
that,
given
the
lack
of
certain
data,
such
as
proposed
metabolic
pathway
for
s
metolachlor
and
identification
of
metabolites
for
both
chemicals,
and
uncertainties
about
findings
in
some
studies,
such
as
quantitative
differences
in
metabolites,
it
was
not
possible
to
determine
if
the
metabolism
of
the
racemic
mixture
and
s
metolachlor
are
comparable.
However,
the
Committee
questioned
how
much
this
information
contributed
to
assessing
the
relative
toxicity
of
metolachlor
and
s
metolachlor.
Given
inherent
variabilities
in
the
results
of
the
available
metabolism
studies,
it
was
concluded
that
additional
metabolism
studies
might
not
add
more
understanding
than
the
current
information.
The
MARC
has
determined
that
the
residues
of
toxicological
concern
are
the
same
for
both
metolachlor
and
s
metolachlor.
Rationale
for
Endpoint
Selection:
HED's
Hazard
Identification
Assessment
Review
Committee
(HIARC)
met
on
September
6,
2001
and
reviewed
the
toxicology
databases
for
metolachlor
and
s
metolachlor
with
regard
to
the
acute
and
chronic
reference
doses
(RfDs)
and
the
toxicological
endpoint
selection
for
use
as
14
appropriate
in
occupational/
residential
risk
assessments.
The
HIARC
concluded
that
smetolachlor
and
metolachlor
have
comparable
toxicity
profiles.
Studies
with
both
chemicals
were
used
interchangeably
for
toxicology
endpoint
selection.
A
complete
toxicology
profile
for
both
metolachlor
and
s
metolachlor
can
be
found
in
Tables
1
and
2
of
Appendix
A.
A
summary
of
the
doses
and
endpoints
selected
for
human
health
risk
assessment
is
presented
in
Table
2
of
this
document.
A
more
thorough
explanation
of
the
rationale
for
endpoint
selection
is
included
below:
Acute
Dietary
Endpoint:
The
acute
reference
dose
(RfD)
of
3.0
mg/
kg/
day
is
based
on
a
prenatal
developmental
toxicity
study
in
rats
with
metolachlor,
and
is
calculated
as
the
NOAEL
(300
mg/
kg/
day)
divided
by
the
total
uncertainty
factor
of
100X
(10X
for
interspecies
extrapolation
and
10X
for
intraspecies
variability).
The
acute
endpoint
is
based
on
an
increased
incidence
of
death,
clinical
signs
of
toxicity
(clonic
and/
or
tonic
convulsions,
excessive
salivation,
urinestained
abdominal
fur
and/
or
excessive
lacrimation)
and
decreased
body
weight
gain
seen
at
the
Lowest
Observed
Adverse
Effect
Level
(LOAEL)
of
1000
mg/
kg/
day.
It
is
noted
that
although
increased
incidence
of
death
is
one
of
the
effects
seen,
it
was
seen
at
a
dose
(1000
mg/
kg/
day)
approximately
three
times
higher
than
the
dose
(300
mg/
kg/
day)
that
caused
these
deaths;
therefore,
the
Agency
is
confident
that
adequate
safety
is
provided
to
protect
the
public
from
dietary
exposure
to
residues
of
metolachlor.
Since
the
FQPA
safety
factor
is
reduced
to
1X,
the
acute
RfD
is
equal
to
the
aPAD.
The
PAD
is
a
modification
of
the
acute
or
chronic
RfD
to
accommodate
the
FQPA
safety
factor,
and
is
calculated
as
the
RfD
divided
by
the
FQPA
safety
factor.
Since
clinical
signs
are
observed
after
a
single
oral
dose
of
metolachlor,
the
duration
and
route
of
administration
are
appropriate
for
the
risk
assessment.
Salivation
alone
is
seen
at
300
mg/
kg/
day;
however,
as
this
effect
is
most
likely
due
to
gastric
irritation
and
there
is
no
other
evidence
of
treatment
related
toxicity,
the
finding
is
not
considered
toxicologically
significant.
Developmental
effects
observed
are
not
attributable
to
a
single
exposure
and
therefore,
a
separate
endpoint
has
not
been
identified
for
females
13
50.
Chronic
Dietary
Endpoint:
The
chronic
RfD
of
0.10
mg/
kg/
day
is
based
on
a
chronic
toxicity
study
in
dogs
with
metolachlor,
and
is
calculated
as
the
NOAEL
(9.7
mg/
kg/
day)
divided
by
the
100X
UF.
The
chronic
endpoint
is
based
on
decreased
body
weight
gain
in
females
at
the
LOAEL
of
33.0
mg/
kg/
day.
Since
the
FQPA
safety
factor
is
reduced
to
1X,
the
chronic
RfD
is
equal
to
the
chronic
PAD.
The
study
duration
and
route
of
administration
are
appropriate
for
this
risk
assessment.
Short
term
Incidental
Oral:
The
short
term
incidental
oral
NOAEL
of
50
mg/
kg/
day,
from
a
prenatal
developmental
toxicity
study
in
rats
with
s
metolachlor,
is
based
on
increased
incidence
of
clinical
signs,
decreased
body
weight/
body
weight
gain,
food
consumption
and
food
efficiency
seen
at
the
LOAEL
(500
mg/
kg/
day)
in
maternal
animals.
The
endpoint
is
appropriate
for
the
population
of
concern
(infants
and
children).
The
Committee
noted
that
the
NOAEL
(20
mg/
kg/
day)
for
the
prenatal
developmental
toxicity
study
in
rabbits
with
s
metolachlor
(MRID
15
43928924)
was
lower
than
the
50
mg/
kg/
day
from
the
rat
developmental
study.
However,
the
endpoint
was
based
on
clinical
signs
of
toxicity
(increase
in
little/
none/
soft
stool
observations)
at
100
mg/
kg/
day.
Although
there
was
a
dose
related
increase
in
this
sign,
it
is
not
evidence
of
frank
toxicity
and
was
judged
not
be
appropriate
for
risk
assessment.
Therefore,
the
rabbit
study
with
s
metolachlor
was
not
selected
for
this
exposure
scenario.
Intermediate
term
Incidental
Oral:
The
intermediate
term
incidental
oral
NOAEL
of
8.8
mg/
kg/
day,
from
a
subchronic
toxicity
study
in
dogs
with
metolachlor,
is
based
on
decreased
body
weight
gain
seen
at
the
LOAEL
of
29.4
mg/
kg/
day.
The
endpoint
and
study
duration
are
appropriate
for
the
population
of
concern
(infants
and
children).
Dermal
Absorption:
A
dermal
absorption
value
of
58%
has
been
selected,
based
on
an
available
dermal
absorption
study
in
rats
with
metolachlor.
The
percentage
of
the
applied
dose
found
in
blood,
urine,
feces,
carcass
and
cage
was
increased
during
the
period
between
skin
wash
(10
hours)
and
sacrifice
(72
hours).
During
the
same
period,
the
levels
in
the
skin
decreased
by
a
similar
amount.
This
observation
suggested
that
metolachlor
retained
in
skin
was
absorbed
during
the
pre
sacrifice
period.
Therefore,
the
HIARC
selected
58%
dermal
absorption
value
based
on
the
combined
values
at
10
hours
measurement
(33%)
and
at
the
amount
remaining
on
the
skin
(25%).
Short
and
Intermediate
Term
Dermal
Endpoints:
No
hazard
was
identified
for
quantification
of
risk
following
dermal
exposure.
In
a
21
day
dermal
toxicity
study
(MRID
41833101),
no
systemic
toxicity
was
seen
following
repeated
dermal
application
of
metolachlor
(96.4%
a.
i.)
to
the
intact
skin
of
five
New
Zealand
rabbits/
sex/
group
at
doses
of
0,
10,
100
or
1000
mg/
kg/
day
for
21
days.
No
prenatal
developmental
toxicity
studies
with
metolachlor
or
s
metolachlor
were
appropriate
for
this
risk
assessment.
There
was
no
evidence
of
developmental
effects
in
rats
or
rabbits
at
maternally
toxic
doses
with
either
metolachlor
or
s
metolachlor,
except
in
the
rat
prenatal
developmental
toxicity
study.
In
this
study,
there
were
slightly
decreased
number
of
implantations
per
dam,
decreased
number
of
live
fetuses/
dam,
increased
number
of
resorptions/
dam
and
significant
decrease
in
mean
fetal
body
weight
but
only
at
1000
mg/
kg/
day
which
was
extremely
toxic
to
dams
(death,
clinical
signs
of
toxicity
and
decreased
body
weight
gain).
Long
term
Dermal
Endpoint:
The
long
term
dermal
NOAEL
of
9.7
mg/
kg/
day,
from
a
chronic
toxicity
study
in
dogs
with
metolachlor,
is
based
on
decreased
body
weight
gain
in
females
at
the
LOAEL
of
33.0
mg/
kg/
day.
The
treatment
period
(21
days)
in
the
dermal
toxicity
study
with
metolachlor
was
not
considered
to
be
of
sufficient
duration
for
these
compounds
since
effects
seen
in
chronic
oral
studies
could
also
be
observed
with
long
term
dermal
administration.
Therefore,
the
HIARC
selected
an
oral
NOAEL
for
this
exposure
scenario,
and
since
an
oral
study
was
selected,
the
dermal
absorption
factor
(58%)
should
be
applied.
Short
term
Inhalation
Endpoint:
The
short
term
inhalation
NOAEL
of
50
mg/
kg/
day,
from
an
oral
prenatal
developmental
toxicity
study
in
rodents
with
s
metolachlor,
is
based
on
increased
incidence
of
clinical
signs,
decreased
body
weight/
body
weight
gain,
food
consumption
and
food
16
efficiency
at
the
LOAEL
of
500
mg/
kg/
day
in
maternal
animals.
Since
an
oral
study
was
selected,
a
100%
absorption
factor
should
be
applied.
Intermediate
Term
Inhalation
Endpoint:
The
intermediate
term
inhalation
NOAEL
of
8.8
mg/
kg/
day,
from
a
subchronic
oral
toxicity
study
in
dogs
with
metolachlor,
is
based
on
decreased
body
weight
gain
at
the
LOAEL
of
29.4
mg/
kg/
day.
Since
an
oral
study
was
selected,
a
100%
absorption
factor
should
be
applied.
Long
Term
Inhalation
Endpoint:
The
long
term
inhalation
NOAEL
of
9.7
mg/
kg/
day,
from
a
chronic
toxicity
study
in
dogs
with
metolachlor,
is
based
on
decreased
body
weight
gain
in
females
at
the
LOAEL
of
33
mg/
kg/
day.
Since
an
oral
study
was
selected,
a
100%
absorption
factor
should
be
applied.
Target
MOE
for
residential
and
aggregate
exposure:
A
target
MOE
(NOAEL/
exposure)
is
the
level
above
which
the
Agency
does
not
have
a
risk
concern.
For
metolachlor,
a
target
MOE
of
100
is
considered
adequate
for
dermal
and
inhalation
residential
exposure,
as
well
as
for
aggregate
exposure.
The
target
MOE
of
100
includes
the
FQPA
safety
factor
of
1X.
17
Table
2.
Summary
of
Toxicological
Dose
and
Endpoints
for
Metolachlor
for
Use
in
Human
Risk
Assessment
Exposure
Scenario
Dose
(mg/
kg/
day)
and
Uncertainty
Factor
(UF)
Endpoint
for
Risk
Assessment
Study
Acute
Dietary
(all
population
subgroups)
NOAEL
=
300
UF
=
100x
FQPA
Safety
Factor
=
1x
death,
clinical
signs
of
toxicity
(clonic
and/
or
tonic
convulsions,
excessive
salivation,
urine
stained
abdominal
fur
and/
or
excessive
salivation)
and
decreased
body
weight
gain
Prenatal
developmental
toxicity
study
in
rats
with
metolachlor
Acute
PAD
=
3.0
mg/
kg/
day
Chronic
Dietary
(all
population
subgroups)
NOAEL=
9.7
UF
=
100
FQPA
Safety
Factor
=
1x
decreased
body
weight
gain
in
females
Chronic
study
in
dogs
with
metolachlor
Chronic
PAD
=
0.1
mg/
kg/
day
Incidental
Oral,
Short
Term
(one
to
30
days)
NOAEL
=
50
Target
MOE
=
100
increased
incidence
of
clinical
signs,
decreased
body
weight/
body
weight
gain,
food
consumption,
and
food
efficiency
Prenatal
developmental
toxicity
study
in
rats
with
s
metolachlor
Incidental
Oral,
Intermediate
Term
(one
month
to
180
days)
NOAEL
=
8.8
Target
MOE
=
100
decreased
body
weight
gain
Subchronic
(6
month)
toxicity
study
in
dogs
with
metolachlor
Dermal,
Short
and
Intermediate
Term
Hazard
was
not
identified
for
quantification
of
risk.
No
systemic
toxicity
was
seen
at
the
limit
dose
(1000
mg/
kg/
day)
following
dermal
applications
and
there
is
no
concern
for
developmental
toxicity
in
rats
or
rabbits.
Dermal,
Long
Term
a
(greater
than
180
days)
Oral
NOAEL
=
9.7
Target
MOE
=
100
decreased
body
weight
gain
in
females
chronic
toxicity
study
in
dogs
with
metolachlor
Inhalation,
Short
Term
b
Oral
NOAEL
=
50
Target
MOE
=
100
increased
incidence
of
clinical
signs,
decreased
body
weight/
body
weight
gain,
food
consumption,
and
food
efficiency
Prenatal
development
toxicity
study
in
rats
with
s
metolachlor
Inhalation,
Intermediate
Term
b
Oral
NOAEL
=
8.8
Target
MOE
=
100
decreased
body
weight
gain
subchronic
(6
month)
toxicity
study
in
dogs
with
metolachlor
Exposure
Scenario
Dose
(mg/
kg/
day)
and
Uncertainty
Factor
(UF)
Endpoint
for
Risk
Assessment
Study
18
Inhalation,
Long
Term
b
Oral
NOAEL
=
9.7
Target
MOE
=
100
decreased
body
weight
gain
in
females
chronic
toxicity
study
in
dogs
with
metolachlor
*
The
reference
to
the
FQPA
Safety
Factor
refers
to
any
additional
safety
factor
retained
due
to
concerns
unique
to
the
FQPA.
a
Since
an
oral
NOAEL
was
selected,
a
dermal
absorption
factor
of
58%
should
be
used
in
route
to
route
extrapolation.
b
Since
an
oral
NOAEL
was
selected,
an
inhalation
factor
of
100%
should
be
used
in
route
to
route
extrapolation.
3.4
Endocrine
Disruption
EPA
is
required
under
the
Federal
Food,
Drug,
and
Cosmetic
Act
(FFDCA),
as
amended
by
FQPA,
to
develop
a
screening
program
to
determine
whether
certain
substances
(including
all
pesticide
active
and
other
ingredients)
"may
have
an
effect
in
humans
that
is
similar
to
an
effect
produced
by
a
naturally
occurring
estrogen,
or
other
such
endocrine
effects
as
the
Administrator
may
designate."
Following
the
recommendations
of
its
Endocrine
Disruptor
Screening
and
Testing
Advisory
Committee
(EDSTAC),
EPA
determined
that
there
was
scientific
bases
for
including,
as
part
of
the
program,
the
androgen
and
thyroid
hormone
systems,
in
addition
to
the
estrogen
hormone
system.
EPA
also
adopted
EDSTAC's
recommendation
that
the
Program
include
evaluations
of
potential
effects
in
wildlife.
For
pesticide
chemicals,
EPA
will
use
FIFRA
and,
to
the
extent
that
effects
in
wildlife
may
help
determine
whether
a
substance
may
have
an
effect
in
humans,
FFDCA
authority
to
require
the
wildlife
evaluations.
As
the
science
develops
and
resources
allow,
screening
of
additional
hormone
systems
may
be
added
to
the
Endocrine
Disruptor
Screening
Program
(EDSP).
When
the
appropriate
screening
and/
or
testing
protocols
being
considered
under
the
Agency's
EDSP
have
been
developed,
metolachlor
may
be
subjected
to
additional
screening
and/
or
testing
to
better
characterize
effects
related
to
endocrine
disruption.
4.0
Exposure
Assessment
and
Characterization
4.1
Summary
of
Registered
Uses
Metolachlor
and
s
metolachlor
are
broad
spectrum
herbicides
that
are
a
member
of
the
chloroacetanilide
group
of
pesticides.
They
are
used
primarily
for
grassy
weed
control
in
many
agricultural
food
and
feed
crops
(major
crop
uses
include
corn,
soybeans,
and
sorghum);
residential
lawns
(by
certified
applicator
only);
commercial
turf
(including
golf
courses,
sports
fields,
recreation
areas,
and
sod
farms);
ornamental
plants,
trees,
and
shrubs,
and
vines;
hedge
rows;
and
horticultural
nurseries.
Types
of
weeds
controlled
by
metolachlor
and
s
metolachlor
include,
but
are
not
limited
to,
the
following:
pigweed,
carpetweed,
waterhemp,
chickweed,
goosefoot,
ragweed,
broomweed,
morning
glory,
crabgrass,
witchgrass,
foxtail,
and
nightshade.
[NOTE:
That
Agency
acknowledges
that
Syngenta
no
longer
holds
any
active
registrations
for
19
(racemic)
metolachlor
end
use
products;
however,
a
search
of
the
Agency's
REFS
system
on
5/
9/
2002
shows
that
there
is
a
registration
for
a
(racemic)
metolachlor
technical
product
that
is
still
held
by
Syngenta
(EPA
Reg.
No.
100
587).
Until
this
registration
is
revoked,
the
Agency
will
proceed
with
a
tolerance
reassessment
decision
for
racemic
metolachlor,
based
on
all
crops
that
metolachlor
may
be
used
on,
as
allowed
for
by
the
technical
label].
Metolachlor
and
s
metolachlor
are
formulated
as
emulsifiable
concentrates
(most
common),
flowable
concentrate,
soluble
concentrates,
ready
to
use
formulations,
and
as
granular
formulations.
Application
methods
may
include
the
following:
ground
application
(most
common),
aerial
application,
irrigation
systems,
and
chemigation
(center
pivot
only).
For
residential
lawns,
a
hose
end
sprayer,
backpack
sprayer,
or
handgun
application
may
be
used.
Application
timing
is
as
follows:
pre
plant,
at
plant,
preemergence,
and
postemergence.
Metolachlor
and
s
metolachlor
are
generally
applied
one
time
per
year.
Application
rates
range
from
approximately
one
to
four
pounds
a.
i.
per
acre,
with
the
application
rate
of
s
metolachlor
being
approximately
35
percent
less
than
that
used
historically
for
metolachlor.
This
risk
assessment
is
a
tolerance
reassessment
only;
therefore,
exposures
to
occupational
handlers
of
metolachlor/
s
metolachlor
are
not
assessed
in
this
document.
Potential
sources
of
non
occupational
exposure
to
metolachlor/
s
metolachlor
include
exposure
from
residues
in
food
and
drinking
water,
and
postapplication
exposure
of
homeowners
and
infants/
children
to
residues
of
s
metolachlor
remaining
on
treated
lawns
or
turf.
Non
occupational
exposure
from
spray
drift
is
also
discussed
in
this
tolerance
reassessment
eligibility
decision
document.
4.2
Dietary
Exposure/
Risk
Pathway
4.2.1
Residue
Profile
Tolerances
for
residues
of
both
metolachlor
and
s
metolachlor
in
or
on
raw
agricultural
commodities
include
the
combined
residues
of
(free
and
bound)
metolachlor
and
its
metabolites,
determined
as
the
derivatives,
CGA
37913
and
CGA
47951,
each
expressed
as
parent
compound.
Permanent
tolerances
for
metolachlor
residues
have
been
established
on
various
plant
commodities
ranging
from
0.1
ppm
in/
on
numerous
commodities
to
30.0
ppm
in/
on
peanut
forage
and
hay
[40
CFR
§180.368(
a)].
Time
limited
tolerances
associated
with
section
18
emergency
exemptions
have
been
established
for
metolachlor
residues
in/
on
grass
forage
and
hay,
spinach,
and
tomato
commodities
[40
CFR
§180.368(
b)].
Tolerances
associated
with
regional
registrations
have
also
been
established
for
metolachlor
residues
in/
on
dry
bulb
onions,
cabbage,
and
various
peppers
(chili,
Cubanelle,
and
tabasco)
[40
CFR
§180.368(
c)].
Tolerances
for
metolachlor
currently
cover
residues
of
s
metolachlor
on
the
same
commodities
for
the
same
use
pattern
when
the
maximum
use
rate
of
s
metolachlor
is
approximately
35
percent
less
than
the
historical
use
rate
of
metolachlor.
Although
smetolachlor
is
applied
at
lower
application
rates
than
metolachlor,
there
are
currently
no
data
available
to
reassess
the
s
metolachlor
tolerances
at
lower
levels
than
metolachlor.
However,
HED
does
recommend
that
a
separate
tolerance
section
be
established
under
§180.368
for
s
20
C
H
3
NH
CH
3
HO
CH
3
C
H
3
CH
3
N
O
O
OH
C
H
3
metolachlor.
Tolerances
for
metolachlor
should
be
listed
under
§180.368(
a)(
1)
through
(d)(
1),
and
tolerances
for
s
metolachlor
should
be
listed
under
§180.368(
a)(
2)
through
(d)(
2).
A
summary
of
the
tolerance
reassessment
and
recommended
modifications
in
commodity
definitions
for
metolachlor
and
s
metolachlor
are
presented
in
Appendix
A,
Tables
3
and
4,
respectively.
Nature
of
the
Residue
in
Plants
The
qualitative
nature
of
metolachlor
residues
in
plants
is
adequately
understood
based
upon
adequate
corn,
potato,
and
soybean
metabolism
studies.
The
metabolism
of
metolachlor
involves
conjugation
with
glutathione,
breakage
of
this
bond
to
form
mercaptan,
conjugation
of
the
mercaptan
with
glucuronic
acid,
hydrolysis
of
the
methyl
ether,
and
conjugation
of
the
resultant
alcohol
with
a
neutral
sugar.
A
minor
pathway
may
involve
sugar
conjugation
of
metolachlor
directly
to
the
corresponding
oxo
compounds.
Residues
of
concern
in
plants
include
metolachlor
and
its
metabolites,
determined
as
the
derivatives
CGA
37913
and
CGA
49751.
The
structures
of
the
metabolites
are
shown
in
Figure
1
below.
The
residues
of
concern
for
smetolachlor
are
the
same
as
for
metolachlor
(L.
Kutney
memo,
D226780,
11/
12/
96);
however,
the
Agency
is
currently
reviewing
additional
submitted
data
(D278742
and
D279110).
These
data
will
be
incorporated
into
future
assessments
for
metolachlor
and
s
metolachlor.
Figure
1.
Chemical
names
and
structures
of
metolachlor
residues
of
concern
in
plants
and
animals.
Common
names/(
Codes)
Chemical
name
Chemical
Structure
CGA
37913
2[(
2
ethyl
6
methylphenyl)
amino]
1
propanol
CGA
49751
4(
2
ethyl
6
methylphenyl)
2
hydroxy
5
methyl
3
morpholinone
Nature
of
the
Residue
in
Livestock:
21
Adequate
studies
are
available
depicting
the
metabolism
of
metolachlor
in
ruminants
and
poultry.
Metolachlor
is
rapidly
metabolized
and
almost
totally
eliminated
in
the
urine
and
feces
of
ruminants
(goats),
non
ruminants
(rats),
and
poultry.
Metolachlor
per
se
was
not
detected
in
any
of
the
excreta
or
tissues.
As
in
plants,
metolachlor
residues
of
concern
in
livestock
commodities
include
metolachlor
and
its
metabolites,
determined
as
the
derivatives
CGA
37913
and
CGA
49751.
The
residues
of
concern
for
s
metolachlor
in
animals
are
the
same
as
for
metolachlor;
however,
the
Agency
is
currently
reviewing
additional
submitted
data
(D278742
and
D279110).
These
data
will
be
incorporated
into
future
assessments
for
metolachlor
and
smetolachlor
Residue
Analytical
Methods
The
Pesticide
Analytical
Manual
(PAM)
Vol.
II,
lists
a
GC/
NPD
method
(Method
I)
for
determining
residues
in/
on
plants
and
a
GC/
MSD
method
(Method
II
)
for
determining
residues
in
livestock
commodities.
These
methods
determine
residues
of
metolachlor
and
its
metabolites
as
either
CGA
37913
or
CGA
49751
following
acid
hydrolysis.
Residue
data
from
the
most
recent
field
trials
and
processing
studies
were
obtained
using
an
adequate
GC/
NPD
method
AG612
which
is
a
modification
of
Method
I.
Multi
residue
Method
Testing
Adequate
data
are
available
on
the
recovery
of
metolachlor
through
Multi
residue
Method
Testing
Protocols.
The
FDA
PESTDATA
database
indicates
that
metolachlor
is
completely
recovered
through
Method
302,
PAM
Vol.
I
(3
rd
ed.,
revised
10/
97).
Storage
Stability
Data
Adequate
storage
stability
data
are
available
to
support
the
crop
field
trials
and
processing
studies.
In
plant
commodities,
the
parent
compound
and
all
residues
convertible
to
CGA
37913
are
stable
at
#
10
C
for
at
least
2
years
in
corn
(grain
and
forage),
peanuts,
potatoes
(tubers,
wet
peel
and
flakes),
soybeans
(hulls
and
meal)
and
tomatoes,
for
at
least
29
months
in
cottonseed
oil,
and
for
at
least
37
months
in
cottonseed
and
corn
oil.
The
derivative
CGA
49751
is
also
stable
at
#
10
C
for
at
least
2
years
in
corn
(grain,
forage,
and
oil),
peanuts,
potatoes
(tubers,
wet
peel
and
flakes),
soybeans
(hulls
and
meal)
and
tomatoes,
and
for
at
least
37
months
in
cottonseeds
and
cottonseed
oil.
For
livestock
commodities,
data
are
available
indicating
that
CGA
49751
is
stable
at
15
C
for
up
to
25
months
in
milk,
eggs,
beef
liver
and
muscle.
The
derivative
CGA
37913
is
stable
at
15
C
for
up
to
25
months
in
milk
and
eggs,
12
months
in
beef
liver,
and
2
months
in
beef
muscle.
More
recent
storage
stability
data
for
CGA
37913
indicated
that
it
is
stable
at
20
C
in
beef
muscle
for
up
to
12
months;
however,
HED
has
concluded
that
the
original
storage
stability
studies
for
beef
muscle
were
more
representative
of
the
conditions
encountered
during
the
feeding
study;
therefore,
the
original
studies
would
be
assumed
to
be
valid
and
residues
of
CGA
37913
in
beef
muscle
will
be
corrected
for
loss
during
frozen
storage.
22
Magnitude
of
the
Residue
in
Crops
Adequate
metolachlor
residue
data
are
available
for
both
metolachlor
and
s
metolachlor
in/
on
celery,
corn
(field
and
sweet),
cottonseed,
grasses
grown
for
seed,
potatoes,
safflower,
and
sorghum.
An
adequate
number
of
field
trials
have
been
conducted
on
these
crops
and
depict
residues
resulting
from
the
application
of
metolachlor
at
the
maximum
labeled
or
proposed
use
rate.
Adequate
metolachlor
and
s
metolachlor
data
are
also
available
for
legume
vegetable
foliage,
peanuts,
soybeans,
spinach,
and
tree
nuts
provided
the
specified
metolachlor
and
smetolachlor
label
amendments
are
made.
There
are
adequate
metolachlor
data
available
for
tomatoes;
however,
copies
of
the
labels
must
be
provided
specifying
a
PHI
of
90
days
and
a
maximum
of
one
post
emergence
application
of
3.0
lb
ai/
A
for
metolachlor,
and
1.9
lb
ai/
A
for
smetolachlor
The
available
residue
data
for
metolachlor
are
summarized
on
a
crop
by
crop
basis
in
the
residue
chemistry
chapter
(S.
Kinard
memo,
D282931,
5/
22/
2002).
To
support
current
or
proposed
tolerances
for
metolachlor
and
s
metolachlor,
residue
data
are
required
reflecting
the
maximum
use
rates
on
the
following
crops
or
commodities:
(i)
representative
succulent,
shelled
peas
and
beans,
to
support
the
use
on
legume
vegetables;
(ii)
bell
peppers,
to
support
a
pending
tolerance
on
peppers;
and
(iii)
corn,
sorghum,
and
soybean
aspirated
grain
fractions.
Maximum
use
rates
for
s
metolachlor
are
35
percent
less
than
the
use
rate
for
metolachlor
on
comparable
crops.
The
available
bridging
studies
on
corn
and
soybeans
indicate
that
residues
resulting
from
the
application
of
s
metolachlor
are
likely
to
be
lower
than
for
metolachlor;
therefore,
the
available
metolachlor
residue
data
will
support
comparable
uses
of
s
metolachlor
provided
that
the
labeled
use
rates
for
s
metolachlor
are
35
percent
lower
than
the
metolachlor
use
rates.
However,
for
those
uses
that
result
in
residues
well
above
the
method
LOQ
(0.08
ppm),
such
as
corn
forage,
residue
data
for
s
metolachlor
will
be
required
to
reassess
tolerances
if
s
metolachlor
completely
replaces
a
particular
use
of
metolachlor.
Current
examples
of
this
include
the
special
local
need
(SLN)
uses
on
cabbage
and
dry
bulb
onions.
Tolerances
for
both
cabbage
and
dry
bulb
onion
are
1.0
ppm,
and
all
metolachlor
SLN
labels
for
these
uses
have
been
replaced
by
SLNs
associated
with
s
metolachlor.
Accordingly,
residue
data
are
required
for
s
metolachlor
on
cabbage
and
onions.
For
cases
in
which
the
current
tolerance
for
metolachlor
is
set
at
or
near
the
method
LOQ,
such
as
celery
(0.1
ppm),
additional
s
metolachlor
residue
data
will
not
be
required
if
the
comparable
use
of
metolachlor
is
canceled.
Magnitude
of
the
Residue
in
Processed
Food/
Feed
Adequate
processing
studies
are
available
for
corn,
cottonseed,
peanuts,
potatoes,
safflower,
soybeans
and
tomatoes.
The
data
from
the
corn,
cottonseed
and
safflower
studies
indicate
that
metolachlor
residues
do
not
concentrate
in
processed
commodities
from
these
crops;
however,
the
peanut,
potato,
soybean,
and
tomato
processing
studies
indicated
that
there
is
the
potential
for
concentration
of
metolachlor
residues
in
several
commodities.
These
data
can
be
translated
to
support
the
use
of
s
metolachlor.
A
summary
of
the
residue
data
by
crop
may
be
found
in
the
residue
chemistry
chapter
(S.
Kinard
memo,
D282931,
5/
22/
2002).
23
Magnitude
of
the
Residue
in
Meat,
Milk,
Poultry,
and
Eggs
Tolerance
reassessment
requirements
for
magnitude
of
the
residue
in
meat,
milk,
poultry,
and
eggs
are
fulfilled.
Adequate
ruminant
and
poultry
feeding
studies
are
available
for
metolachlor,
and
these
data
will
also
support
the
use
of
s
metolachlor.
Confined
Accumulation
in
Rotational
Crops
HED
has
concluded
that
the
confined
rotational
crop
study
for
metolachlor
was
inadequate
but
potentially
upgradable.
Additional
data
are
required
characterizing
the
14
C
residues
in
plants,
along
with
information
on
the
percentage
of
the
14
C
residues
measured
by
the
current
enforcement
method,
supporting
storage
stability
data,
and
sample
storage
conditions
and
intervals.
Codex/
International
Harmonization
No
maximum
residue
limits
(MRLs)
for
either
metolachlor
or
s
metolachlor
have
been
established
or
proposed
by
Codex,
Canada,
or
Mexico
for
any
agricultural
commodity;
therefore,
no
compatibility
questions
exist
with
respect
to
U.
S.
tolerances.
4.2.2
Dietary
Exposure
Metolachlor
and
s
metolachlor
acute
and
chronic
dietary
exposure
assessments
were
conducted
using
the
Dietary
Exposure
Evaluation
Model
(DEEM™)
software
Version
7.73,
which
incorporates
consumption
data
from
USDA's
Continuing
Surveys
of
Food
Intake
by
Individuals
(CSFII),
1989
1992.
The
1989
92
data
are
based
on
the
reported
consumption
of
more
than
10,000
individuals
over
three
consecutive
days,
and
therefore
represent
more
than
30,000
unique
"person
days"
of
data.
Foods
"as
consumed"
(e.
g.,
apple
pie)
are
linked
to
raw
agricultural
commodities
and
their
food
forms
(e.
g.,
apples
cooked/
canned
or
wheat
flour)
by
recipe
translation
files
internal
to
the
DEEM
software.
Consumption
data
are
averaged
for
the
entire
US
population
and
within
population
subgroups
for
chronic
exposure
assessment,
but
are
retained
as
individual
consumption
events
for
acute
exposure
assessment.
For
chronic
exposure
and
risk
assessment,
an
estimate
of
the
residue
level
in
each
food
or
foodform
(e.
g.,
orange
or
orange
juice)
on
the
commodity
residue
list
is
multiplied
by
the
average
daily
consumption
estimate
for
that
food/
food
form.
The
resulting
residue
consumption
estimate
for
each
food/
food
form
is
summed
with
the
residue
consumption
estimates
for
all
other
food/
food
forms
on
the
commodity
residue
list
to
arrive
at
the
total
estimated
exposure.
Exposure
estimates
are
expressed
in
mg/
kg
body
weight/
day
and
as
a
percent
of
the
cPAD.
This
procedure
is
performed
for
each
population
subgroup.
For
acute
exposure
assessments,
individual
one
day
food
consumption
data
are
used
on
an
individual
by
individual
basis.
The
reported
consumption
amounts
of
each
food
item
can
be
multiplied
by
a
residue
point
estimate
and
summed
to
obtain
a
total
daily
pesticide
exposure
for
a
24
deterministic
(Tier
1
or
Tier
2)
exposure
assessment.
The
resulting
distribution
of
exposures
is
expressed
as
a
percentage
of
the
aPAD
on
both
a
user
(i.
e.,
those
who
reported
eating
relevant
commodities/
food
forms)
and
a
per
capita
(i.
e.,
those
who
reported
eating
the
relevant
commodities
as
well
as
those
who
did
not)
basis.
In
accordance
with
HED
policy,
per
capita
exposure
and
risk
are
reported
for
all
Tiers
of
analysis;
however,
for
Tiers
1
and
2,
significant
differences
in
user
vs.
per
capita
exposure
and
risk
are
identified.
The
DEEM™
analyses
estimated
the
acute
and
chronic
dietary
exposure
for
the
general
U.
S.
population
and
26
population
subgroups.
The
results
reported
in
Table
3
are
for
the
U.
S.
Population
(total),
all
infants
(<
1
year
old),
children
1
6,
children
7
12,
females
13
50,
males
13
19,
males
20
and
older,
and
seniors
55
and
older.
The
results
for
the
other
population
subgroups
are
not
reported
in
Table
3.
This
is
because
the
numbers
of
respondents
in
the
other
subgroups
were
not
sufficient,
and
thus
the
exposure
estimates
for
these
subgroups
contained
higher
levels
of
uncertainty;
however,
the
respondents
in
these
subgroups
were
also
part
of
larger
subgroups
which
are
listed
in
Table
3.
For
example,
nursing
and
non
nursing
infants
are
included
in
all
infants.
Subgroups
broken
down
by
region,
season,
and
ethnicity
are
also
not
included
in
Table
3.
4.2.2.1
Acute
Dietary
Risk
Estimates
A
conservative
Tier
1
acute
dietary
exposure
assessment
was
conducted
for
all
labeled
metolachlor
and
s
metolachlor
food
uses.
Inputs
for
this
assessment
included
tolerance
level
residue
values
and
an
assumption
that
100%
of
all
labeled
crops
were
treated
with
metolachlor/
smetolachlor
For
all
supported
registered
commodities,
the
acute
dietary
exposure
estimates
are
below
the
Agency's
level
of
concern
(<
100%
aPAD)
at
the
95
th
exposure
percentile
for
the
general
U.
S.
population
and
all
population
subgroups.
The
acute
dietary
risk
estimate
for
the
highest
exposed
population
subgroup,
children
1
6
years
of
age,
is
<1%
of
the
aPAD.
Acute
dietary
risk
estimates
are
not
of
concern.
Results
of
the
acute
dietary
risk
assessment
are
presented
in
Table
3.
4.2.2.2
Chronic
Dietary
Risk
Estimates
A
conservative
Tier
1
chronic
dietary
exposure
assessment
was
conducted
for
all
supported
metolachlor
and
s
metolachlor
food
uses.
For
all
supported
registered
commodities,
the
chronic
dietary
exposure
estimates
are
below
the
Agency's
level
of
concern
(<
100%
cPAD)
for
the
general
U.
S.
population
and
all
population
subgroups.
The
chronic
dietary
risk
estimate
for
the
highest
exposed
population
subgroup,
children
1
6
years
of
age,
is
3%
of
the
cPAD.
Chronic
dietary
risk
estimates
are
not
of
concern.
Results
of
the
chronic
dietary
risk
assessment
are
presented
in
Table
3.
The
Agency
notes
that
the
conservative
Tier
1
dietary
assessments
for
metolachlor
and
smetolachlor
could
be
refined
for
more
realistic
dietary
exposure
estimates
by
using
available
percent
crop
treated
estimates,
field
trial
and
monitoring
data,
and
processing
factors;
however,
the
estimated
dietary
risk
to
metolachlor
and
s
metolachlor
is
not
of
concern
for
all
populations
in
both
the
acute
and
chronic
assessments.
Further
refinements
are
not
warranted
at
this
time.
25
26
Table
3.
Summary
of
Dietary
Exposure
Estimates
for
Metolachlor
and
S
metolachlor
Population
Subgroup
Acute
Dietary
Chronic
Dietary
Dietary
Exposure
(mg/
kg/
day)
%
aPAD
Dietary
Exposure
(mg/
kg/
day)
%
cPAD
U.
S.
Population
(total)
0.
003822
<1
0.001454
2
All
Infants
(<
1
year)
0.
005245
<1
0.001872
2
Children
1
6
years
0.
006876
<1
0.003171
3
Children
7
12
years
0.
004636
<1
0.002153
2
Females
13
50
0.002699
<1
0.001121
1
Males
13
19
0.003489
<1
0.001541
2
Males
20+
years
0.
002747
<1
0.001191
1
Seniors
55+
0.002578
<1
0.001072
1
4.2.2.3
Cancer
Dietary
Exposure/
Risk
Metolachlor
has
been
classified
as
a
Group
C,
possible
human
carcinogen,
based
on
liver
tumors
in
rats
seen
at
the
highest
dose
tested
of
150
mg/
kg/
day.
The
Cancer
Assessment
Review
Committee
met
on
July
27,
1994,
and
determined
that
carcinogenic
risks
to
metolachlor
should
be
quantitated
using
a
non
linear
approach,
with
a
NOAEL
of
15
mg/
kg/
day
based
on
neoplastic
nodules/
hepatocellular
carcinomas
seen
at
150
mg/
kg/
day
in
the
chronic
toxicity/
carcinogenicity
study
in
rats.
The
Cancer
Assessment
Review
Committee
notes
that
the
NOAEL
used
for
calculating
the
cancer
MOE
values
(15
mg/
kg/
day)
is
comparable
to
the
NOAEL
of
9.7
mg/
kg/
day
selected
for
establishing
the
chronic
reference
dose
for
metolachlor.
Therefore,
a
separate
cancer
dietary
risk
assessment
was
not
conducted
as
it
is
assumed
that
the
chronic
dietary
endpoint
is
protective
for
cancer
dietary
exposure.
4.3
Water
Exposure/
Risk
Pathway
A
drinking
water
assessment
for
metolachlor
and
s
metolachlor
was
conducted
by
the
Environmental
Fate
and
Effects
Division
(EFED)
and
involved
the
analysis
of
surface
and
ground
water
monitoring
data,
prospective
ground
water
study
data,
and
Tier
I
(FIRST
and
SCIGROW
and
Tier
II
(PRZM/
EXAMS)
modeling
results.
This
assessment
includes
concentrations
of
parent
metolachlor/
s
metolachlor
and
the
degradates
metolachlor
ethanesulfonic
acid
(ESA)
and
metolachlor
oxanilic
acid
(OA).
Although
it
was
determined
by
the
Metabolism
Assessment
Review
Committee
that
the
ESA
and
OA
metabolites
appear
to
be
less
toxic
than
parent
metolachlor/
s
metolachlor,
they
are
included
in
this
risk
assessment
since
they
were
found
in
greater
abundance
than
the
parent
in
water
monitoring
studies.
27
The
Agency
notes
that
a
key
assumption
of
the
drinking
water
assessment
is
that
reported
monitoring
data
represent
both
racemic
metolachlor
and
s
metolachlor.
The
analytical
methods
for
surface
and
ground
water
monitoring
data
used
in
this
assessment
are
unable
to
distinguish
between
metolachlor
and
s
metolachlor.
However,
EFED
believes
that
the
fate
properties
of
racemic
metolachlor
and
s
metolachlor
are
similar.
Therefore,
the
EECs
used
in
this
risk
assessment
are
representative
of
both
racemic
metolachlor
and
s
metolachlor.
The
environmental
fate
database
is
complete
for
metolachlor.
Parent
metolachlor/
s
metolachlor
appear
to
be
moderately
persistent
to
persistent,
and
range
from
mobile
to
highly
mobile
in
different
soils.
Metolachlor/
s
metolachlor
have
reportedly
been
detected
as
far
as
the
36
to
48
inch
soil
layer
in
some
studies.
Degradation
appears
to
be
dependent
on
microbially
mediated
and
abiotic
processes.
The
frequency
of
detection
of
metolachlor/
s
metolachlor
from
evaluated
monitoring
data
suggest
that
contamination
in
drinking
water
sources
is
widespread.
Environmental
fate
data
comparing
metolachlor
and
s
metolachlor
indicate
that
both
are
expected
to
have
similar
degradation
pathways
and
rates
in
soil
and
water
environments,
and
both
are
expected
to
be
mobile
to
highly
mobile
in
soil
and
water
environments.
EECs
for
Parent
Metolachlor/
S
Metolachlor:
No
surface
or
ground
water
monitoring
studies
that
specifically
target
metolachlor/
s
metolachlor
were
available
for
the
drinking
water
assessment.
As
a
result,
the
drinking
water
assessment
for
parent
metolachlor/
s
metolachlor
is
based
primarily
on
monitoring
data
from
the
following
sources:
the
United
States
Geological
Survey
(USGS)
National
Water
Quality
Assessment
(NAWQA)
database,
the
US
EPA
STORET
database,
the
Acetochlor
Registration
Partnership
(ARP)
database,
and
two
USGS
Reservoir
Monitoring
studies.
The
acute
estimated
environmental
concentration
(EEC)
of
77.6
ppb
was
selected
from
the
NAWQA
database,
and
the
chronic
EEC
of
4.3
ppb
was
selected
from
the
maximum
annual
time
weighted
mean
from
the
NAWQA
data.
These
values
represent
the
estimated
concentration
of
parent
metolachlor/
s
metolachlor
in
surface
water,
and
are
supported
by
the
metolachlor
concentrations
from
the
National
Contaminant
Occurrence
Database
representing
analysis
of
treated
drinking
water,
as
well
as
from
model
predictions
using
PRZM/
EXAMS.
When
the
monitoring
data
and
modeling
data
are
considered
together,
there
is
a
general
agreement
between
the
various
sources
of
information
used
in
the
assessment.
Acute
and
chronic
concentrations
of
parent
metolachlor/
s
metolachlor
in
ground
water
were
modeled
using
SCI
GROW.
SCI
GROW
estimates
the
upper
bound
ground
water
concentrations
of
pesticides
likely
to
occur
when
the
pesticide
is
used
at
the
maximum
allowable
rate
in
areas
with
ground
water
vulnerable
to
contamination.
Estimates
were
based
on
two
applications
to
corn/
turf
for
a
total
of
4
lbs
ai/
acre
(the
maximum
application
rate).
In
comparison
to
the
SCI
GROW
estimate
of
5.5
ppb
in
shallow
ground
water,
the
Iowa
NAWQA
data
have
a
maximum
concentration
of
15.4
ppb.
However,
it
should
be
noted
that
the
second
highest
concentration
of
parent
metolachlor/
s
metolachlor
in
the
Iowa
NAWQA
data
is
1.7
ppb.
Additionally,
recent
data
collected
by
the
Suffolk
Country,
New
York
Department
of
Health
28
Services,
Bureau
of
Groundwater
Resources
indicate
that
both
metolachlor
and
s
metolachlor,
and
its
degradates,
have
been
detected
in
ground
water.
In
data
collected
between
1997
and
2001,
metolachlor/
s
metolachlor
was
detected
in
60
well
samples
with
a
maximum
concentration
of
83
ppb.
No
information
was
available
on
frequency
of
detection
and
only
summary
statistics
were
provided
on
these
data;
therefore,
these
data
were
not
used
quantitatively
in
the
risk
assessment.
However,
these
data
suggest
that
the
SCI
GROW
estimates
for
metolachlor/
smetolachlor
are
not
overestimating
the
potential
impact
of
metolachlor/
s
metolachlor
use
on
ground
water.
Of
note,
parent
metolachlor/
s
metolachlor
was
not
detected
in
two
prospective
ground
water
studies
that
have
been
completed.
The
SCI
GROW
estimate
of
5.5
ppb
in
ground
water
is
appropriate
for
risk
assessment
purposes.
EECs
for
Metolachlor
ESA
and
OA
Degradates:
Only
two
small
data
sets
were
available
on
the
ESA
and
OA
degradates
from
the
Iowa
and
Illinois
NAWQA
data.
In
the
absence
of
more
robust
monitoring
data
for
the
degradates,
upperbound
Tier
I
estimates
for
ESA
and
OA
based
on
FIRST
and
SCI
GROW
modeling
were
used
to
calculate
EECs
for
the
degradates.
The
modeling
used
conservative
assumptions
of
selected
fate
parameters
(aerobic
soil
metabolism
rate
constant
and
soil
partitioning
coefficient)
as
well
as
the
maximum
application
rate
of
4
lbs
ai/
acre
on
turf/
corn.
Acute
and
chronic
estimates
of
metolachlor
ESA
in
surface
water
(based
on
FIRST
modeling)
are
31.9
ppb
and
22.8
ppb,
respectively.
Acute
and
chronic
estimates
of
metolachlor
OA
in
surface
water
are
91.4
ppb
and
65.1
ppb,
respectively.
The
Agency
notes
that
the
application
rate
used
for
metolachlor
ESA
and
OA
in
the
model
runs
was
estimated
by
converting
maximum
label
rates
for
each
use
by
the
maximum
percentage
of
degradate
found
in
fate
studies.
In
addition,
each
application
rate
was
corrected
for
molecular
weight
differences
of
each
degradate.
However,
EFED
could
not
establish
a
statistically
significant
relationship
between
parent
metolachlor
and
degradates;
therefore,
the
amount
of
degradate
is
an
uncertainty
in
this
assessment.
Acute
and
chronic
estimates
of
metolachlor
ESA
in
ground
water
(based
on
SCI
GROW
modeling,
turf/
corn
scenario)
are
not
expected
to
exceed
65.8
ppb.
This
value
is
considered
representative
of
both
peak
and
long
term
average
concentrations
because
of
the
inherent
transport
nature
of
ground
water
(generally
slow
movement
from
the
source
of
contamination
both
laterally
and
horizontally).
Acute
and
chronic
estimates
of
metolachlor
OA
in
ground
water
(also
based
on
the
turf
/corn
scenario)
are
not
expected
to
exceed
31.7
ppb.
The
Agency
notes
that
these
values
exceed
those
detected
in
the
Iowa
NAWQA
study
(63.7
ppb
for
metolachlor
ESA
and
4.4
ppb
for
metolachlor
OA),
and
also
exceed
those
values
detected
in
two
PGW
studies
(metolachlor
ESA
was
detected
at
a
maximum
concentration
of
24
ppb
while
metolachlor
OA
was
detected
at
a
maximum
concentration
of
15.6
ppb).
In
addition,
recent
data
collected
by
the
Suffolk
Country,
New
York
Department
of
Health
Services,
Bureau
of
Groundwater
Resources
indicate
that
both
metolachlor
and
s
metolachlor,
and
its
degradates,
have
been
detected
in
ground
water.
In
data
collected
between
1997
and
2001,
metolachlor
ESA
was
detected
in
296
well
samples
with
a
maximum
concentration
of
39.7
ppb,
while
metolachlor
OA
was
detected
in
228
wells
with
a
maximum
concentration
of
49.6
ppb.
No
information
was
29
available
on
frequency
of
detection
and
only
summary
statistics
were
provided
on
these
data;
therefore,
these
data
were
not
used
quantitatively
in
the
risk
assessment.
However,
these
data
suggest
that
the
SCI
GROW
estimates
for
metolachlor
ESA
and
OA
are
slightly
overestimating
the
potential
impact
of
metolachlor/
s
metolachlor
use
on
ground
water.
Drinking
Water
Levels
of
Comparison
(DWLOCs):
In
the
absence
of
chemical
specific
monitoring
data,
the
Agency
uses
drinking
water
levels
of
comparison
to
calculate
aggregate
risk.
A
drinking
water
level
of
comparison,
or
a
DWLOC,
is
a
theoretical
upper
limit
on
a
pesticide's
concentration
in
drinking
water
in
light
of
total
aggregate
exposure
to
a
pesticide
in
food,
drinking
water,
and
through
residential
uses.
In
other
words,
the
DWLOC
value
represents
the
maximum
theoretical
exposure
a
person
may
have
to
pesticide
residues
through
drinking
water,
after
their
exposure
to
the
pesticide's
residues
through
food
and
residential
exposure
have
been
taken
into
consideration.
The
Office
of
Pesticide
Programs
uses
DWLOCs
internally
in
the
risk
assessment
process
as
a
surrogate
measure
of
potential
exposure
associated
with
pesticide
exposure
through
drinking
water.
DWLOC
values
are
not
regulatory
standards
for
drinking
water;
however,
they
do
have
an
indirect
regulatory
impact
through
aggregate
exposure
and
risk
assessments.
DWLOCs
are
calculated
for
each
type
of
risk
assessment
as
appropriate
(acute,
short
term,
intermediate
term,
chronic,
and
cancer)
and
compared
to
the
appropriate
estimated
concentration
of
a
pesticide
in
surface
and
ground
water,
as
provided
by
EFED.
If
the
DWLOC
is
greater
than
the
estimated
surface
and
ground
water
concentration,
(i.
e.,
if
the
DWLOC
>
EEC),
the
Agency
concludes
with
reasonable
certainty
there
is
no
drinking
water
risk
of
concern.
A
summary
of
aggregate
exposure
and
risk,
including
DWLOC
calculations,
may
be
found
in
Section
5.0
of
this
document.
4.4
Residential
Exposure/
Risk
Pathway
4.4.1
Home
Uses
4.4.1.1
Residential
Handler
Exposure
The
Agency
notes
that
Syngenta
does
not
currently
hold
any
active
end
use
product
registrations
for
metolachlor.
S
metolachlor
is
registered
(as
an
emulsifiable
concentrate
formulation)
for
use
on
lawn,
turf
(including
sod
farms),
golf
courses,
sports
fields,
and
ornamental
gardens.
Although
not
labeled
as
a
restricted
use
pesticide,
the
label
as
it
is
currently
marketed
is
not
intended
for
homeowner
purchase
or
use.
On
this
basis,
a
residential
handler
is
not
expected
to
be
exposed
to
residues
of
s
metolachlor.
Therefore,
a
residential
handler
assessment
was
not
conducted.
4.4.1.2
Residential
Postapplication
Exposure
There
is
potential
for
postapplication
exposure
to
adults
and
children
resulting
from
the
use
of
s
30
metolachlor
on
residential
lawns.
Although
the
use
sites
for
s
metolachlor
vary
from
golf
courses
to
ornamental
gardens,
the
residential
lawn
scenario
represents
what
the
Agency
considers
the
likely
upper
end
of
possible
exposure.
Postapplication
exposures
from
various
activities
following
lawn
treatment
are
considered
to
be
the
most
common
and
significant
in
residential
settings.
Postapplication
exposure
is
considered
to
be
short
term
(one
to
30
days
of
exposure)
only,
based
on
a
label
specification
of
a
six
week
interval
before
the
re
application
of
s
metolachlor.
The
registrant
has
also
indicated
a
label
revision
to
limit
application
to
one
time
per
season.
A
short
term
dermal
endpoint
was
not
selected,
since
no
systemic
toxicity
was
seen
at
the
limit
dose
of
1000
mg/
kg/
day;
therefore,
a
dermal
risk
assessment
was
not
conducted
and
dermal
exposures
are
assumed
to
be
minimal.
Postapplication
inhalation
exposure
is
also
expected
to
be
minimal
since
s
metolachlor
is
only
applied
in
an
outdoor
setting,
the
vapor
pressure
is
low
(2.8
x
10
5
mm
Hg
at
25
C),
and
the
label
specifies
that
residents
should
not
re
enter
treated
areas
until
after
sprays
have
dried.
The
following
postapplication
incidental
oral
scenarios
following
application
to
lawns
and
turf
have
been
identified:
1)
short
term
oral
exposure
to
toddlers
and
children
following
hand
tomouth
exposure;
2)
short
term
oral
exposure
to
toddlers
and
children
following
object
to
mouth
exposure;
and
3)
short
term
oral
exposure
to
toddlers
and
children
following
soil
ingestion.
The
term
"incidental"
is
used
to
distinguish
the
inadvertent
oral
exposure
of
small
children
from
exposure
that
may
be
expected
from
treated
foods
or
residues
in
drinking
water.
Since
the
FQPA
safety
factor
for
the
protection
of
children
and
infants
was
reduced
to
1X,
a
target
MOE
value
of
100
has
been
identified
for
residential
assessments.
MOE
values
greater
than
100
are
not
considered
to
be
of
concern
to
the
Agency.
MOE
estimates
are
based
on
the
dose
level
of
50
mg/
kg/
day
established
for
short
term
oral
risk
assessment.
The
HED
Standard
Operating
Procedures
for
Residential
Exposure
Assessments
(Draft,
December
18,
1997)
were
used
as
a
guideline
for
the
residential
postapplication
assessment.
Also,
standard
values
for
turf
transferable
residues,
turf
transfer
coefficients,
and
hand
to
mouth
activities
were
used
as
amended
by
Exposure
Policy
12
(Science
Advisory
Panel
on
Exposure,
February
22,
2001).
The
exposure
and
risk
estimates
for
the
three
residential
exposure
scenarios
are
assessed
for
the
day
of
application
(day
"0")
since
children
will
likely
contact
the
lawn
immediately
following
application.
The
following
estimates/
assumptions
were
used
in
the
risk
assessment:
°
A
single
application
at
the
maximum
label
rate
of
2.47
lb
ai/
acre
for
s
metolachlor.
°
Exposure
duration
for
children
is
assumed
to
be
2
hours
per
day.
°
The
exposed
child's
weight
is
15
kg
(33
pounds).
31
°
Turf
transferable
residue
(TTR)
value
of
5%,
and
object
to
mouth
residue
value
of
20%
of
the
application
rate
assumed.
An
explanation
of
the
exposure
calculations
and
formula
used
in
the
assessment
may
be
found
in
the
Residential
Risk
Assessment
chapter
(R.
Griffin
memo,
2/
20/
2002).
The
exposure
estimates
for
the
three
postapplication
scenarios
(object
to
mouth,
hand
to
mouth,
and
incidental
soil
ingestion)
were
combined
to
represent
the
possible
(if
not
likely)
high
end
oral
exposure
resulting
from
lawn
(or
similar
use).
Combined
post
application
oral
risk
estimates
for
s
metolachlor
are
not
of
concern.
Table
4
summarizes
the
results
of
the
residential
postapplication
assessment:
Table
4:
Summary
of
Residential
Postapplication
MOE
Values
Exposure
Scenario
a
S
Metolachlor
b
Oral
Dose
(mg/
kg/
day)
Oral
Short
term
MOE
c
Object
to
mouth
S
metolachlor
0.
0092
5400
Hand
to
mouth
S
metolachlor
0.
037
1400
Soil
ingestion
S
metolachlor
0.
00012
400,000
Combined
exposure
S
metolachlor
0.
046
1100
a
Exposure
scenario
represents
oral
exposure
of
children,
with
an
assumed
body
weight
of
15
kg.
b
S
metolachlor
application
rate
is
2.47
lb
ai/
acre.
c
Short
term
oral
MOE
=
NOAEL/
Dose,
where
short
term
oral
NOAEL
=
50
mg/
kg/
day.
The
Agency
acknowledges
that
Syngenta
has
no
remaining
residential
end
use
product
labels
for
racemic
metolachlor;
however,
for
informational
purposes,
the
combined
oral
MOE
estimates
for
metolachlor
(based
on
EPA
Reg.
No.
100
691
and
a
label
rate
of
4
lb
ai/
acre)
are
670
and
not
of
concern.
4.4.2
Recreational
Uses
S
metolachlor
may
be
used
on
sports
and
recreational
fields,
as
well
as
golf
courses.
However,
the
Agency
believes
that
children's
exposure
to
residues
of
s
metolachlor
remaining
on
residential
lawns
after
treatment
represents
the
likely
upper
end
of
exposure.
Furthermore,
since
dermal
and
inhalation
risks
are
not
of
concern,
and
oral
exposures
from
sports
and
recreational
fields,
as
well
as
golf
courses,
are
expected
to
be
minimal,
risks
for
these
other
non
occupational
settings
are
expected
to
be
insignificant.
4.4.3
Other
(Spray
Drift
etc.)
Spray
drift
is
always
a
potential
source
of
exposure
to
residents
nearby
to
spraying
operations.
This
is
particularly
the
case
with
aerial
application,
but,
to
a
lesser
extent,
could
also
be
a
potential
source
of
exposure
from
groundboom
application
methods.
The
Agency
has
been
working
with
the
Spray
Drift
Task
Force,
EPA
Regional
Offices
and
State
Lead
Agencies
for
32
pesticide
regulation,
and
other
parties
to
develop
the
best
spray
drift
management
practices.
The
Agency
is
now
requiring
interim
mitigation
measures
for
aerial
applications
that
must
be
placed
on
product
labels/
labeling.
The
Agency
has
completed
its
evaluation
of
the
new
data
base
submitted
by
the
Spray
Drift
Task
Force,
a
membership
of
U.
S.
pesticide
registrants,
and
is
developing
a
policy
on
how
to
appropriately
apply
the
data
and
the
AgDRIFT
computer
model
to
its
risk
assessments
for
pesticides
applied
by
air,
orchard
airblast
and
ground
hydraulic
methods.
After
the
policy
is
in
place,
the
Agency
may
impose
further
refinements
in
spray
drift
management
practices
to
reduce
off
target
drift
and
risks
associated
with
aerial
as
well
as
other
application
types
where
appropriate.
HED
has
conducted
a
direct
exposure
assessment
for
the
use
of
s
metolachlor
on
lawns,
and
determined
that
there
is
no
risk
of
concern
from
this
use.
No
additional
risk
to
s
metolachlor
is
expected
from
spray
drift.
4.5
Incidents
Reports
A
review
of
metolachlor
incident
reports
was
conducted
by
HED
in
August,
1997.
The
following
incident
data
bases
were
consulted:
the
OPP
Incident
Data
System
(IDS),
Poison
Control
Centers,
California
Department
of
Pesticide
Regulation;
and
the
National
Pesticide
Telecommunications
Network
(NPTN).
HED
determined
that
no
serious
illnesses
that
could
be
attributed
to
metolachlor
have
been
reported
in
data
sources
available
to
the
EPA.
Although
more
cases
of
incidents
involving
metolachlor
have
been
reported
in
Poison
Control
Center
data
and
the
Incident
Data
System
since
1997,
most
of
the
cases
were
minor,
involving
skin
and
eye
irritation.
Two
ingestions
reported
in
the
literature
(one
in
a
pregnant
woman)
did
not
result
in
significant
effects.
These
findings
do
not
alter
the
conclusions
reached
in
the
August,
1997
incident
report
memo
(personal
communication
between
C.
Jarvis
and
J.
Blondell
on
10/
29/
2001).
5.0
Aggregate
Risk
Assessments
and
Risk
Characterizations
5.1
Acute
Risk
5.1.1
Aggregate
Acute
Risk
Assessment
An
acute
aggregate
risk
assessment
addresses
potential
exposure
from
combined
residues
of
metolachlor/
s
metolachlor
on
food
and
in
drinking
water
(both
surface
and
ground
water).
Potential
residential
exposures
are
not
incorporated
into
an
acute
aggregate
risk
assessment.
As
show
in
Table
5a,
EFED's
EECs
are
below
the
Agency's
back
calculated
DWLOC
values
for
the
parent
compound,
the
ESA
degradate,
and
the
OA
degradate.
The
combined
value
of
the
parent
plus
the
degradates
is
also
below
the
acute
DWLOC
value.
The
Agency
concludes
that
acute
aggregate
risk
estimates
are
not
of
concern
for
any
population
subgroup.
33
5.1.2
Acute
DWLOC
Calculations
Table
5a.
Acute
DWLOC
Calculations
Population
Subgroup
1
Acute
Scenario
aPAD
mg/
kg/
d
Acute
Food
Exp
mg/
kg/
d
Max
Acute
Water
Exp
mg/
kg/
day
2
Ground
Water
EEC
(ppb)
3
Surface
Water
EEC
(ppb)
3
Acute
DWLOC
(
F
g/
L)
4
Parent
ESA
OA
Total
5
Parent
ESA
OA
Total
5
U.
S.
Population
3.0
0.
003822
3.0
5.
5
65.8
31.7
103
77.6
31.9
91.4
200.9
1.
0
x
10
5
Females
13
50
3.0
0.
002699
3.0
5.
5
65.8
31.7
103
77.6
31.9
91.4
200.9
9.
0
x
10
4
Children
1
6
3.0
0.
006876
3.0
5.
5
65.8
31.7
103
77.6
31.9
91.4
200.9
3.
0
x
10
4
Males
13
19
3.0
0.
003489
3.0
5.
5
65.8
31.7
103
77.6
31.9
91.4
200.9
1.
0
x
10
5
1
Population
subgroups
are
representative
of
those
with
the
highest
dietary
exposure
values.
Standard
body
weights
and
water
consumption
values
are
as
follows:
70
kg/
2L
per
day
(adult
male/
general
population);
60
kg/
2L
per
day
(adult
female);
10
kg/
1L
per
day
(child).
2
Maximum
acute
water
exposure
(mg/
kg/
day)
=
[(
acute
PAD
(mg/
kg/
day)
acute
food
exposure
(mg/
kg/
day)]
3
The
crop
producing
the
highest
level
was
used.
4
Acute
DWLOC(
F
g/
L)
=
[maximum
acute
water
exposure
(mg/
kg/
day)
x
body
weight
(kg)]
[water
consumption
(L)
x
10
3
mg/
F
g]
5
"Total"
represents
the
combined
value
of
parent
plus
the
ESA
and
OA
degradates.
34
5.2
Short
Term
Risk
5.2.1
Aggregate
Short
Term
Risk
Assessment
A
short
term
aggregate
risk
assessment
considers
potential
exposure
from
food,
drinking
water,
and
short
term,
non
occuapational
(residential)
pathways
of
exposure.
For
s
metolachlor,
potential
short
term,
non
occupational
risk
scenarios
include
oral
exposure
of
children
to
treated
lawns.
In
this
aggregate
short
term
risk
assessment,
exposure
from
food,
drinking
water,
and
residential
lawns
s
metolachlor
use
only)
has
been
considered.
Since
only
children
have
the
potential
for
non
occupational,
short
term
risk,
they
are
the
only
population
subgroup
included
below.
Short
term
DWLOC
values
have
been
calculated
for
s
metolachlor
only,
since
Syngenta
no
longer
holds
any
[racemic]
metolachlor
residential
end
use
products.
As
shown
in
Table
5b,
EFED's
EECs
for
the
parent
compound,
the
ESA
degradate,
and
the
OA
degradate
are
below
the
short
term
s
metolachlor
DWLOC
value
for
children.
The
combined
value
of
the
parent
plus
the
degradates
is
also
below
the
short
term
s
metolachlor
DWLOC
value.
The
Agency
concludes
that
short
term
aggregate
risks
from
s
metolachlor
are
not
of
concern.
For
informational
purposes,
it
is
noted
that
the
EEC
values
for
the
parent
compound,
ESA
degradate,
and
the
OA
degradate
are
below
the
metolachlor
short
term
DWLOC
value
for
children.
The
combined
value
of
the
parent
plus
the
degradates
is
also
below
the
metolachlor
short
term
DWLOC
value.
5.2.2
Short
Term
DWLOC
Calculations
Table
5b.
Short
Term
Aggregate
Risk
and
DWLOC
Calculations
Population
Short
Term
Scenario
Chemical
Target
MOE
1
MOE
food
2
MOE
oral
3
Aggregate
MOE
(food
and
residential)
6
MOE
water
7
Allowable
water
exposure
8
(mg/
kg/
day)
Ground
Water
EEC
9
(ppb)
Surface
Water
EEC
9
(ppb)
DWLOC
10
(
F
g/
L)
Parent
ESA
OA
Total
11
Paren
t
ESAOA
Total
1
1
Children
(1
6)
S
moc
100
1.6
x
10
4
1100
1000
110
0.45
5.5
65.8
32
103.3
4.
3
22.8
65.1
92.2
4500
1
The
target
MOE
of
100
is
based
on
the
100x
uncertainty
factor,
and
the
1x
FQPA
safety
factor.
Aggregate
risks
above
100
are
not
of
concern.
2
MOE
food
=
[short
term
oral
NOAEL
(50
mg/
kg/
day)/
chronic
dietary
exposure
of
children
(0.003171
mg/
kg/
day)]
3
MOE
oral
=
[short
term
oral
NOAEL
(50
mg/
kg/
day)/
combined
hand
to
mouth,
object
to
mouth,
and
soil
ingestion
oral
exposure
(0.
046
mg/
kg/
day
s
moc)]
35
4
MOE
dermal
=
not
applicable
(n/
a).
No
dermal
toxicity
seen
at
the
limit
dose.
5
MOE
inhalation
=
not
applicable.
Postapplication
inhalation
exposure
is
expected
to
be
minimal.
6
Aggregate
MOE
(food
and
residential)
=
1÷[
[(
1÷
MOE
food)
+
(1÷
MOE
oral)]]
7
Water
MOE
=
1÷
[[(
1÷
Target
Aggregate
MOE)
(1÷
Aggregate
MOE
(food
and
residential)]]
8
Allowable
water
exposure
=
Short
term
Oral
NOAEL
÷
MOE
water
9
The
crop
producing
the
highest
level
was
used
(i.
e.,
turf)
10
DWLOC(
F
g/
L)
=
[allowable
water
exposure
(mg/
kg/
day)
x
body
weight
(kg)]
[water
consumption
(L)
x
10
3
mg/
F
g]
11
"Total"
represents
the
combined
value
of
the
parent
plus
the
ESA
and
OA
degradates.
36
5.3
Intermediate
Term
Risk
5.3.1
Aggregate
Intermediate
Term
Risk
Assessment
An
intermediate
term
aggregate
risk
assessment
considers
potential
exposure
from
food,
drinking
water,
and
non
occupational
(residential)
pathways
of
exposure.
However,
for
metolachlor/
s
metolachlor,
no
intermediate
term
non
occupational
exposure
scenarios
(greater
than
30
days
exposure)
are
expected
to
occur.
Therefore,
intermediate
term
DWLOC
values
were
not
calculated
and
an
intermediate
term
aggregate
risk
assessment
is
not
required.
5.4
Chronic
Risk
5.4.1
Aggregate
Chronic
Risk
Assessment
A
chronic
aggregate
risk
assessment
considers
chronic
exposure
from
food,
drinking
water,
and
non
occupational
(residential)
pathways
of
exposure.
For
metolachlor
and
s
metolachlor,
there
are
no
chronic
(greater
than
180
days
of
exposure)
non
occupational
exposure
scenarios.
Therefore,
the
chronic
aggregate
risk
assessment
will
consider
exposure
from
food
and
drinking
water
only.
As
shown
in
Table
5c,
EFED's
EECs
for
the
parent
compound,
the
ESA
degradate,
and
the
OA
degradate
are
below
the
Agency's
chronic
DWLOC
values
for
all
population
subgroups.
The
combined
value
of
the
parent
plus
degradates
is
also
below
the
chronic
DWLOC
value.
The
Agency
concludes
that
chronic
aggregate
risks
are
not
of
concern.
5.4.2
Chronic
DWLOC
Calculations
Table
5c.
Chronic
DWLOC
Calculations
Population
Subgroup
1
Chronic
Scenario
cPAD
mg/
kg/
day
Chronic
Food
Exp
mg/
kg/
day
Max
Chronic
Water
Exp
mg/
kg/
day
2
Ground
Water
EEC
(ppb)
3
Surface
Water
EEC
(ppb)
3
Chronic
DWLOC
4
(
F
g/
L)
Parent
ESA
OA
Total
5
Parent
ESA
OA
Total
5
U.
S.
Population
0.1
0.
001454
0.0985
5.5
65.8
31.7
103
4.3
22.8
65.1
92.2
3400
Females
13
50
0.1
0.
001121
0.0989
5.5
65.8
31.7
103
4.3
22.8
65.1
92.2
3000
Children
1
6
0.1
0.
003171
0.0968
5.5
65.8
31.7
103
4.3
22.8
65.1
92.2
1000
Males
13
19
0.1
0.
001541
0.0985
5.5
65.8
31.7
103
4.3
22.8
65.1
92.2
3400
1
Population
subgroups
are
representative
of
those
with
the
highest
dietary
exposure
values.
Standard
body
weights
and
water
consumption
values
are
as
follows:
70
kg/
2L
per
day
(adult
male/
general
population);
60
kg/
2L
per
day
(adult
female);
10
kg/
1L
per
day
(child).
2
Maximum
Chronic
Water
Exposure
(mg/
kg/
day)
=
[Chronic
PAD
(mg/
kg/
day)
Chronic
Dietary
Exposure
(mg/
kg/
day)]
3
The
crop
producing
the
highest
level
was
used.
4
Chronic
DWLOC(
F
g/
L)
=
[maximum
chronic
water
exposure
(mg/
kg/
day)
x
body
weight
(kg)]
[water
consumption
(L)
x
10
3
mg/
F
g]
1
Guidance
for
Identifying
Pesticide
Chemicals
and
Other
Substances
that
Have
a
Common
Mechanism
of
Toxicity,
Office
of
Pesticide
Programs,
USEPA
(issued
for
public
comment
in
August,
1998;
issued
in
revised
form
January
29,
1999).
2
SAP
Report,
April
28,
1997.
Report
of
the
FIFRA
Scientific
Advisory
Panel
Meeting,
March
19
20,
1997.
Held
at
the
Crystal
Gateway
Marriott,
1700
Jefferson
Davis
Highway,
Arlington,
VA
22202.
37
5
"Total"
represents
combined
value
of
parent
plus
ESA
and
OA
degradates.
5.5
Cancer
Risk
5.5.1
Aggregate
Cancer
Risk
Assessment
An
aggregate
cancer
risk
assessment
considers
potential
carcinogenic
exposure
from
food,
drinking
water,
and
non
occupational
(residential)
pathways
of
exposure.
However,
as
noted
earlier
in
this
risk
assessment,
the
NOAEL
that
was
established
based
on
tumors
in
the
rat
(15
mg/
kg/
day,
seen
at
the
highest
dose
tested
of
150
mg/
kg/
day)
is
comparable
to
the
NOAEL
of
9.7
mg/
kg/
day
selected
for
establishing
the
chronic
reference
dose
for
metolachlor.
It
is
assumed
that
the
chronic
dietary
endpoint
is
protective
for
cancer
dietary
exposure.
Therefore,
a
separate
cancer
aggregate
risk
assessment
was
not
conducted,
and
cancer
DWLOC
values
were
not
calculated.
6.0
Cumulative
The
chloroacetanilide
pesticides
represent
a
class
of
food
use
pesticides
that
have
been
given
high
priority
by
OPP
for
the
reassessment
of
tolerances
in
accordance
with
the
mandates
of
FQPA.
The
group
of
chloroacetanilide
pesticides
covered
by
this
review
consists
of
Acetochlor,
Alachlor,
Butachlor,
Metolachlor
and
Propachlor.
Various
members
of
this
group
of
chloroacetanilide
pesticides
have
been
shown
to
result
in
several
different
types
of
tumor
responses
in
laboratory
animals
(e.
g.,
nasal,
thyroid,
liver,
and
stomach
tumors).
Therefore,
as
part
of
the
reassessment,
OPP
scientists
considered
several
different
potential
common
mechanism
of
toxicity
groupings
for
these
chemicals.
In
reviewing
this
issue,
OPP
scientists
were
guided
by
several
relevant
Agency
science
policies,
including
Guidance
for
Identifying
Pesticide
Chemicals
and
Other
Substances
that
Have
a
Common
Mechanism
of
Toxicity
1
.
Additionally,
on
March
19,
1997,
the
Agency
presented
to
the
FIFRA
Scientific
Advisory
Panel
(SAP)
a
draft
case
study
illustrating
the
application
of
the
Common
Mechanism
Guidance
to
the
grouping
of
chloroacetanilide
pesticides
based
on
a
common
mechanism
of
toxicity.
The
SAP
agreed
with
the
Agency's
conclusion
that
there
is
sufficient
evidence
to
support
the
grouping
of
certain
chloroacetanilides
that
cause
nasal
turbinate
tumors
by
a
common
mechanism
of
toxicity
2
.
Upon
consideration
of
the
SAP
comments,
OPP's
own
reviews
and
the
data
underlying
these
3
The
Grouping
of
a
Series
of
Chloroacetanilide
Pesticides
Based
on
a
Common
Mechanism
of
Toxicity,
Office
of
Pesticide
Programs,
USEPA
(June
7,
2001).
38
reviews,
as
well
as
additional
information
received
by
the
Agency
from
registrants
or
presented
in
the
open
literature
since
the
1997
draft
document,
OPP
has
revised
its
science
document
discussing
the
potential
grouping
of
chloroacetanilide
pesticides,
or
a
subgroup
of
them,
based
on
a
common
mechanism
of
toxicity.
In
the
revised
document
entitled
The
Grouping
of
a
Series
of
Chloroacetanilide
Pesticides
Based
on
a
Common
Mechanism
of
Toxicity
3
,
OPP
has
concluded
that
only
some
of
the
pesticides
that
comprise
the
class
of
chloroacetanilides
should
be
designated
as
a
"Common
Mechanism
Group"
based
on
the
development
of
nasal
turbinate
tumors
by
metabolism
to
a
highly
tissue
reactive
moiety,
i.
e.,
quinoneimine.
Thus,
only
Acetochlor,
Alachlor,
and
Butachlor
should
be
grouped
based
on
a
common
mechanism
of
toxicity
for
nasal
turbinate
tumors.
Although
Metolachlor
does
distribute
to
the
nasal
turbinates,
and
might
produce
a
quinoneimine,
it
is
not
apparent
from
currently
available
data
that
it
shares
the
same
target
site
in
the
nasal
tissue
as
Acetochlor,
Alachlor
and
Butachlor.
Although
Propachlor
does
produce
a
precursor
of
a
quinoneimine,
the
available
data
do
not
support
its
tumorigenicity
to
the
nasal
turbinates.
In
conclusion,
it
is
OPP's
position,
at
this
stage
in
the
tolerance
reassessment
process,
that
only
some
chloroacetanilides,
namely
Acetochlor,
Alachlor,
and
Butachlor
should
be
considered
as
a
Common
Mechanism
Group
due
to
their
ability
to
cause
nasal
turbinate
tumors.
For
purposes
of
a
cumulative
risk
assessment
as
a
part
of
the
tolerance
reassessment
process
for
Acetochlor,
Alachlor,
and
Butachlor,
these
three
pesticides
will
be
considered
as
a
Common
Mechanism
Group.
Following
the
initiation
of
a
cumulative
risk
assessment,
further
analyses
of
new
or
existing
data
may
occur
which
could
impact
the
Agency's
evaluation
of
specific
members
of
this
group
or
the
group
as
a
whole.
7.0
Data
Needs/
Label
Requirements
Toxicology
Data
Needs:
The
need
for
a
28
day
inhalation
study
has
been
identified
for
both
metolachlor
and
smetolachlor
Submission
of
this
study
would
allow
the
Agency
to
improve
characterization
regarding
the
concern
for
toxicity
via
the
inhalation
route
of
exposure
following
application
of
metolachlor/
s
metolachlor
on
multiple
days
in
a
commercial
setting.
Registrants
are
recommended
to
follow
the
protocol
for
the
90
day
inhalation
study
provided
in
OPPTS
Guideline
870.3465,
but
cease
exposure
at
28
days.
Residue
Chemistry
Data
Needs:
The
following
residue
chemistry
data
deficiencies
have
been
identified:
°
Residue
data
supporting
the
use
of
S
metolachlor
(EC)
on
cabbage
are
required
and
the
39
registrant
should
pursue
a
section
3
registration
for
s
metolachlor
on
cabbage.
°
Residue
data
on
corn
aspirated
grain
fractions
are
required
for
both
metolachlor
and
smetolachlor
°
A
revised
Section
F
proposing
appropriate
tolerances
for
metolachlor
residues
in/
on
grass
forage
and
grass
hay
should
be
submitted.
°
Residue
data
supporting
shelled,
succulent
peas,
and
beans
are
required.
°
Label
amendments
are
required
for
both
metolachlor
and
s
metolachlor
use
on
legume
vegetable
foliage.
°
Residue
data
supporting
the
use
of
s
metolachlor
(EC)
on
dry
bulb
onions
are
required
and
the
registrant
should
pursue
a
section
3
registration
for
s
metolachlor
on
onion.
°
Label
amendments
are
required
for
both
metolachlor
and
s
metolachlor
use
on
peanut.
°
Additional
residue
data
supporting
bell
peppers
are
required.
°
Residue
data
on
sorghum
aspirated
grain
fractions
are
required
for
both
metolachlor
and
s
metolachlor.
°
Residue
data
on
soybean
aspirated
grain
fractions
are
required
for
both
metolachlor
and
s
metolachlor.
°
Label
amendments
are
required
for
both
metolachlor
and
s
metolachlor
use
on
soybean.
°
Label
amendments
are
required
for
metolachlor
(EC)
use
on
spinach.
If
the
petitioner
intends
to
support
the
3.0
lb
ai/
A
seasonal
rate,
then
data
would
be
required
reflecting
pre
emergence
applications
at
1.0
lb
ai/
A/
crop
to
three
successive
spinach
crops.
°
The
registrant
must
provide
copies
of
labels
including
the
proposed
use
on
tomatoes.
°
Label
amendments
are
required
for
metolachlor
use
on
tree
nuts.
°
Additional
data
are
required
characterizing
the
14
C
residues
in
rotated
crops,
along
with
information
on
the
percentage
of
the
14
C
residues
measured
by
the
current
enforcement
method,
supporting
storage
stability
data,
and
sample
storage
conditions
and
intervals.
°
Residue
data
are
required
depicting
residues
in/
on
representative
rotated
cereal
grains
planted
4.5
months
following
a
single
application
of
metolachlor
at
the
maximum
rate
for
corn.
°
Analytical
grade
reference
standards
are
required
as
requested
by
the
repository
for
metolachlor,
s
metolachlor,
and
all
metabolites
of
concern.
Product
Chemistry
Data
Needs:
The
following
product
chemistry
data
deficiencies
have
been
identified:
°
830.1700
Preliminary
Analysis
(metolachlor;
Syngenta
95%
Technical)
°
830.1800
Enforcement
Analytical
Method
(metolachlor;
Syngenta
95%
Technical)
°
830.7050
UV/
Visible
Absorption
(metolachlor;
Syngenta
95%
Technical)
40
APPENDIX
A
41
Appendix
A
Table
1:
Toxicity
Profile
for
Metolachlor
(PC
Code
108801)
Guideline
No./
Study
Type
MRID
No.
(year)/
Classification
/Doses
Results
870.3100
90
Day
oral
toxicity
rodents
44775401
(1999)
Acceptable/
guideline
0,
30,
300,
3000
ppm
(M/
F:
0,
2.00/
2.32,
20.2/
23.4,
210/
259
mg/
kg/
day)
NOAEL
for
males
=
3000
ppm
LOAEL
for
males
not
established
NOAEL
for
females
=
300
ppm
LOAEL
for
females
=
3000
ppm
based
on
decreased
body
weight/
body
weight
gain
870.3150
180
Day
oral
toxicity
in
nonrodents
00032174
(1980),
43244001
acceptable/
guideline
0,
100,
300,
1000
ppm
(M/
F:
0,
2.92/
2.97,
9.71/
8.77,
29.61/
29.42)
NOAEL
=
300
ppm
LOAEL
=
1000
ppm
based
on
decreased
body
weight
gain
870.3200
21/
28
Day
dermal
toxicity
41833101
(1987)
acceptable/
guideline
0,
10,
100
or
1000
mg/
kg/
day
systemic
NOAEL
=
1000
mg/
kg/
day.
systemic
LOAEL
was
not
established
dermal
irritation
NOAEL
was
not
established
dermal
irritation
LOAEL
=
10
mg/
kg/
day
based
on
very
slight
erythema,
dry
skin
and
fissuring
(one
animal)
870.3700a
Prenatal
developmental
in
rodents
00151941
(1985)
acceptable/
guideline
0,
30,
100,
300
or
1000
mg/
kg/
day
maternal
toxicity
NOAEL
=
300
mg/
kg/
day.
maternal
toxicity
LOAEL
=
1000
mg/
kg/
day
based
on
an
increased
incidence
of
death,
clinical
signs
of
toxicity
(clonic
and/
or
toxic
convulsions,
excessive
salivation,
urine
stained
abdominal
fur
and/
or
excessive
lacrimation)
and
decreased
body
weight
gain.
developmental
toxicity
NOAEL
=
300
mg/
kg/
day
developmental
toxicity
LOAEL
=
1000
mg/
kg/
day
based
on
slightly
decreased
number
of
implantations
per
dam,
decreased
number
of
live
fetuses/
dam,
increased
number
of
resorptions/
dam
and
significant
decrease
in
mean
fetal
body
weight
870.3700b
Prenatal
developmental
in
nonrodents
00041283
(1980)
acceptable/
guideline
0,
36,
120
or
360
mg/
kg/
day
maternal
toxicity
NOAEL
=
120
mg/
kg/
day.
maternal
toxicity
LOAEL
=
360
mg/
kg/
day
based
on
an
increased
incidence
of
clinical
observations
(persistent
anorexia)
and
decreased
body
weight
gain
developmental
toxicity
NOAEL
=
360
mg/
kg/
day
developmental
toxicity
LOAEL
was
not
established.
Guideline
No./
Study
Type
MRID
No.
(year)/
Classification
/Doses
Results
42
870.3800
Reproduction
and
fertility
effects
00080897
(1981)
acceptable/
guideline
0,
30,
300
or
1000
ppm
(F0
males:
0,
2.4,
23.5
and
75.8
mg/
kg/
day;
F0
females:
0,
2.5,
26.0
and
85.7
mg/
kg/
day;
F1
males:
0,
2.3,
23.7
and
76.6
mg/
kg/
day;
F1
females:
0,
2.6,
25.7
and
84.5
mg/
kg/
day).
Parental
toxicity
NOAEL
=
1000
ppm
(F0
males/
females:
75.8/
85.7
mg/
kg/
day;
F1
males/
females:
76.6/
84.5
mg/
kg/
day).
Parental
toxicity
LOAEL
was
not
established
Reproduction
toxicity
NOAEL
=
1000
ppm
(F0
males/
females:
75.8/
85.7
mg/
kg/
day;
F1
males/
females:
76.6/
84.5
mg/
kg/
day).
Reproduction
toxicity
LOAEL
was
not
established
Offspring
NOAEL
=
300
ppm
(F0
males/
females:
23.5/
26.0
mg/
kg/
day;
F1
males/
females:
23.7/
25.7
mg/
kg/
day).
Offspring
LOAEL
=
1000
ppm
(F0
males/
females:
75.8/
85.7
mg/
kg/
day;
F1
males/
females:
76.6/
84.5
mg/
kg/
day)
based
on
decreased
body
weight.
870.4100b
Chronic
toxicity
dogs
40980701,
41164501,
42218601
and
42218602.
(1989)
acceptable/
guideline
0,
100,
300
or
1000
ppm
(males:
0,
3.5,
9.7
and
32.7
mg/
kg/
day,
respectively;
females:
0,
3.6,
9.7
and
33.0
mg/
kg/
day,
respectively)
for
one
year.
NOAEL
=
300
ppm
(9.7
mg/
kg/
day)
for
females
LOAEL
=
1000
ppm
for
females
(33.0
mg/
kg/
day)
based
on
decreased
body
weight
gain
LOAEL
for
males
was
not
established;
NOAEL
=
1000
ppm
(32.7
mg/
kg/
day).
870.4300
Chronic
toxicity/
carcinogenicity
rodents
00129377
(1983)
acceptable/
guideline
0,
30,
300
or
3000
ppm
(0,
1.5,
15
or
150
mg/
kg/
day
based
on
1
ppm
in
food
equals
0.05
mg/
kg/
day)
NOAEL
=
300
ppm
(15
mg/
kg/
day)
for
females
LOAEL
=
3000
ppm
(150
mg/
kg/
day)
for
females
based
on
slightly
decreased
body
weight
gain
and
food
consumption.
The
LOAEL
was
not
established
for
males.
The
NOAEL
was
3000
ppm
(150
mg/
kg/
day).
Administration
of
doses
up
to
3000
ppm
was
associated
with
statistically
significant
increases
in
liver
adenomas
and
combined
adenoma/
carcinoma
in
female
rats.
In
male
rats,
there
was
a
statistically
significant
trend
but
not
pair
wise
significance
for
liver
tumors.
870.4300
Carcinogenicity
mice
00117597
(1982)
acceptable/
guideline
0,
300,
1000
or
3000
ppm
(0,
45,
150
or
450
mg/
kg/
day
based
on
1
ppm
in
food
equals
0.150
mg/
kg/
day)
NOAEL
=
1000
ppm
(150
mg/
kg/
day)
LOAEL
=
3000
ppm
(450
mg/
kg/
day)
based
on
possible
treatmentrelated
deaths
in
females
and
decreased
body
weight/
body
weight
gain
in
males
and
females
no
evidence
of
carcinogenicity
Gene
Mutation
870.5100
bacterial
reverse
mutation
00015397
(1976)
acceptable/
guideline
10,
100,
1000
and
10,000
ug/
plate
negative
up
to
cytotoxic
doses
(1000
ug/
plate)
Guideline
No./
Study
Type
MRID
No.
(year)/
Classification
/Doses
Results
43
Gene
Mutation
870.5300
mouse
lymphoma
00158929
(1984)
acceptable/
guideline
9.5
190
nl/
ml
without
activation;
10.5
280
nl/
ml
with
activation
no
effect
on
the
incidence
of
mutations
in
the
presence
or
absence
of
metabolic
activation
Cytogenetics
870.5395
micronucleus
assay
in
Chinese
hamsters
00158925
(1984)
acceptable/
guideline
0,
1250,
2500
or
5000
mg/
kg
no
effect
of
treatment
on
incidence
of
micronuclei
induction
Cytogenetics
870.5450
dominant
lethal
assay
in
mice
00015630
(1978)
acceptable/
guideline
100
or
300
mg/
kg
no
effect
on
embryonic
death,
pre
and
post
implantation
or
fertility
rates
in
mated
females
Other
Effects
870.5550
DNA
Damage/
Repair
in
rat
hepatocytes
00142828
(1984)
acceptable/
guideline
0.25,
1.25,
6.25,
or
31.25
nl/
ml
negative
Other
Effects
870.5550
DNA
Damage/
Repair
in
human
fibroblasts
00142827
acceptable/
guideline
0.125,
0.625,
3.125
or
15.625
nl/
ml
negative
Other
Effects
870.5550
Unscheduled
DNA
synthesis
in
rat
hepatocytes
43244003
(1994)
acceptable/
guideline
1250,
2500
or
4000
mg/
kg
to
males;
500,
1000
or
1500
mg/
kg
to
females
negative
for
induction
of
UDS;
however,
significant
increases
in
percentage
of
cells
in
S
phase
were
observed
in
females
dosed
at
500
mg/
kg
(but
not
at
1000
or
1500
mg/
kg)
and
sacrificed
at
15
hours
Guideline
No./
Study
Type
MRID
No.
(year)/
Classification
/Doses
Results
44
870.7485
Metabolism
and
pharmacokinetics
MRID
00015425
(1974)
unacceptable
52,
28
or
33
mg/
kg
to
male
rats
Conclusions:
Urinary
metabolites
of
CGA
24705
(N(
2
methoxy
1
methylethyl)
2
ethyl
6
methyl
chloroacetanilide)
were
identified
following
oral
administration
of
52
mg/
kg,
28
mg/
kg,
and
33
mg/
kg
to
male
rats.
Two
metabolites,
each
comprising
approximately
5%
of
chloroform
extractable
urinary
radioactivity,
were
identified
from
oral
administration
of
CGA
24705.
These
were
the
products
CGA
37735
(2
ethyl
6
methylhydroxyacetanilide
in
which
N
dealkylation
of
R1
(the
N(
2
methoxy
1
methylethyl
side
chain)
and
side
chain
dechlorination
and
oxidation
of
R2
(the
N
chloroacetyl
side
chain)
have
occurred,
and
CGA
46129
(N(
1
carboxy
ethyl)
2
ethyl
6
methyl
hydroxyacetanilide)
in
which
the
ether
bond
of
R1
has
been
split
and
oxidized
to
the
corresponding
carboxylic
acid,
while
R2
is
similar
to
R2
found
in
CGA
37735.
In
study
#7/
74,
these
2
metabolites
each
represented
approximately
5%
of
organic
extractable
urinary
radioactivity,
while
in
study
#12/
74,
the
percentage
found
as
CGA
46129
was
between
20
25%
of
urinary
radioactivity,
and
CGA
37735
represented
between
3
5%
of
organic
extractable
radioactivity.
The
major
metabolic
pathway
proposed
from
analysis
of
urinary
as
well
as
fecal
metabolites
is
one
of
cleavage
of
the
ether
bond
and
subsequent
oxidation
to
the
carboxylic
acid,
as
well
as
hydrolytic
removal
of
the
chlorine
atom.
Conjugation
of
CGA
24705
or
metabolites
with
gluronic
acid
or
sulfate
does
not
appear
to
occur.
Aqueous
extractable
urinary
radioactivity
contained
58%
of
the
total
urinary
radioactivity
and
was
composed
of
5
different
radioactive
fractions,
which
were
not
identified.
Current
guideline
recommendations
as
to
dose
levels
and
use
of
both
sexes
in
metabolism
studies
were
not
followed.
Thus,
whether
the
metabolic
pattern
is
altered
with
dose
or
repeated
exposure
cannot
be
evaluated
from
these
data.
Guideline
No./
Study
Type
MRID
No.
(year)/
Classification
/Doses
Results
45
870.7485
Metabolism
and
pharmacokinetics
40114401
(1987)
unacceptable
Single
low
(1.5
mg/
kg),
single
high
(300
mg/
kg)
and
repeated
low
(1.5
mg/
kg/
day
for
15
days)
Conclusions:
Single
low
(1.5
mg/
kg),
single
high
(300
mg/
kg)
and
repeated
low
(1.5
mg/
kg/
day
for
15
days)
oral
doses
of
metolachlor
were
readily
absorbed
and
eliminated
by
male
and
female
rats.
Urinary
and
fecal
elimination
of
radioactivity
associated
with
orally
administered
[
14
C]
metolachlor
was
essentially
complete
within
48
to
72
hours
after
dosing.
Low
and
high
dose
females
eliminated
14
C
more
rapidly
(p<
0.003,
half
lives
of
elimination,
16.6
and
15.6
hours,
respectively)
than
low
and
high
dose
males
and
repeated
dose
animals
of
both
sexes
(half
lives,
18.2
and
20.0
hours).
Elimination
by
all
animals
followed
first
order
kinetics.
Approximately
one
half
to
two
thirds
(48
to
64
percent)
of
the
14
C
administered
was
recovered
from
the
urine
within
7
days;
similar
amounts
were
present
in
the
feces.
Low
dose
males
eliminated
slightly
more
of
the
radioactive
dose
in
the
feces
(55
percent)
than
the
urine
(48
percent).
The
opposite
trend
was
seen
in
the
low
dose
females
and
repeated
dose
rats
of
both
sexes;
these
animals
excreted
approximately
58
to
64
percent
of
the
14
C
dose
in
the
urine
and
42.5
to
46.5
percent
in
the
feces
within
7
days
after
dosing.
High
dose
animals
excreted
similar
amounts
(58
to
60
percent)
of
the
radioactive
dose
in
the
urine
and
feces.
Total
recoveries
of
14
C
(urine,
feces,
and
tissues)
tended
to
be
high
and
were
between
105
and
122.5
percent.
Relatively
low
levels
of
radioactivity
were
present
in
the
tissues
of
all
animals
at
7
days
postdosing.
Tissues
of
low
and
repeated
dose
rats
contained
approximately
1.6
to
2.5
percent
of
the
14
C
dose;
tissues
of
high
dose
rats
accounted
for
3.2
(females)
and
4.2
(males)
percent.
For
all
groups,
most
of
the
tissue
radioactivity
(1.1
to
3.0
percent
of
the
dose)
was
associated
with
red
blood
cells
(RBCs);
RBCs
also
contained
the
highest
concentrations
of
radio
labeled
compound
(0.6
to
0.9
ppm,
low
and
repeated
dose
rats;
232
and
247
ppm,
high
dose
females
and
males,
respectively),
indicating
that
[
14
C]
metolachlor
and/
or
its
metabolites
bind
extensively
to
these
cells.
The
next
highest
concentrations
of
radiolabel
(0.03
to
0.13
ppm,
low
and
repeated
dose
rats;
7.3
to
37
ppm,
high
dose
animals)
were
present
in
metabolically
active
tissues,
including
the
heart,
lung,
kidney,
liver
and
spleen.
Brain,
bone
and
muscle
contained
the
smallest
amounts
of
radioactivity
(0.004
to
0.015
ppm,
low
and
repeated
dose
rats;
1.7
to
3.5
ppm,
high
dose
rats).
Tissue
14
C
residues
in
high
dose
males
were
approximately
250
to
500
times
greater
than
those
of
low
dose
males,
indicating
that
the
ratio
of
tissue
concentrations
(high
dose:
low
dose)
was
much
larger
than
the
corresponding
dose
ratio
of
200:
1
(300
mg/
kg:
1.5
mg/
kg).
In
contrast,
tissue
14
C
levels
of
females
were,
in
general,
proportionate
to
dose.
Tissues
of
lowand
repeated
dose
rats
contained
similar
amounts
of
radioactivity.
These
data
indicate
that
some
14
C
was
retained
by
all
animals
and
that
the
greatest
potential
for
accumulation
of
radioactivity
was
in
male
rats
given
a
single
high
oral
dose
of
[
14
C]
metolachlor.
Guideline
No./
Study
Type
MRID
No.
(year)/
Classification
/Doses
Results
46
870.7485
Metabolism
and
pharmacokinetics
43164201
(1992)
acceptable/
guideline
low
oral
dose
(1.5
mg/
kg
x
14
days),
and
a
single
high
dose
(300
mg/
kg)
In
a
rat
metabolism
study
(MRID
#
431642
01),
14
C
Metolachlor
was
administered
orally
in
PEG
200
[HWI
6117
208]
or
corn
oil
[ABR
94001]
to
groups
(5
sex/
dose)
of
male
and
female
Sprague
Dawley
rats
at
a
low
oral
dose
(1.5
mg/
kg),
repeated
low
oral
dose
(1.5
mg/
kg
x
14
days),
and
a
single
high
dose
(300
mg/
kg).
Control
animals
(1/
sex)
received
blank
formulation.
Comparison
of
oral
and
intravenous
data
showed
that
of
the
administered
dose,
between
69.6%
and
93.2%
was
absorbed.
Distribution
data
showed
that
the
only
significant
sites
of
residual
radioactivity
at
7
days
post
dose
were
residual
carcass
(0.9
2.2%
of
the
administered
dose)
and
red
blood
cells
(0.95
1.53
F
g
equivalents/
gram
in
blood
cells
for
all
low
dose
male
and
female
rats).
Dosing
regimen
did
not
result
in
any
apparent
accumulation
of
residual
radioactivity.
Excretion
data
showed
that
urine
and
feces
were
both
significant
routes
for
elimination
of
metolachlor
derived
radioactivity.
In
the
low
dose
groups,
the
urine
appeared
more
of
a
predominant
route
for
excretion
in
female
rats
than
in
males,
whereas
fecal
excretion
was
slightly
higher
in
males.
However,
at
the
high
oral
dose,
there
were
no
apparent
sex
related
differences
in
the
pattern
of
urinary
excretion.
Examination
of
urinary
excretion
data
as
presented
in
graphical
format
indicated
that
at
the
300
mg/
kg
dose,
excretion
was
delayed
vs
the
low
oral
dose,
suggesting
saturation
of
elimination.
Metabolism
of
metolachlor
in
this
study
was
complex,
with
up
to
32
metabolites
identified
in
urine
and/
or
feces.
The
"major"
urinary
metabolite
found
in
all
dose
groups
was
the
metabolite
designated
CGA
46129.
This
metabolite
was
present
as
5.6
13.1%
of
the
total
radioactive
residue
(TRR)
in
rat
urine
across
all
dose
groups,
and
was
highest
in
the
intravenously
dosed
group.
In
the
orally
dosed
rats,
the
percentage
of
this
metabolite
decreased
from
approximately
13%
of
TRR
to
between
5.6
9.2%
of
TRR.
Other
metabolites
identified
in
urine
which
constituted
near
or
at
5%
of
TRR
were
U10
(CGA
37735),
U13,
U17,
U1,
"polar
1",
and
"polar
2."
The
radioactivity
constituting
the
`polar
1'
and
`polar
2'
regions
was
further
broken
down
to
at
least
12
components
by
TLC,
but
the
identity
of
the
metabolites
in
these
regions
was
not
demonstrated.
In
feces,
a
similarly
complex
metabolite
profile
was
obtained.
The
"major"
metabolite
observed
in
feces,
F9,
was
identical
to
U7,
or
CGA
46129.
Except
for
intravenously
dosed
rats,
where
the
percentage
of
this
metabolite
in
feces
was
equivalent
in
male
and
female
rats
(11.6
and
13.2%
of
TRR,
respectively),
the
percentage
of
F9
in
feces
of
orally
dosed
rats
was
always
higher
in
males
than
in
females.
Other
fecal
metabolites
identified
at
or
near
5%
of
TRR
in
feces
included
F2
(CGA
41638),
F3
(CGA
133275),
F7,
F8
and
F8',
F16,
F14,
and
F17.
Based
on
these
data,
a
scheme
for
metabolism
of
metolachlor
was
proposed.
47
Appendix
A
Table
2:
Toxicity
Profile
for
S
Metolachlor
(PC
Code
108800)
Guideline
No./
Study
Type
MRID
No.
(year)/
Classification
/Doses
Results
870.3100
90
Day
oral
toxicity
rodents
43928923
(1995)
acceptable/
guideline
0,
30,
300,
3000
or
10000
ppm
(0,
1.5,
15,
150
or
500
mg/
kg/
day)
NOAEL
=
300
ppm
LOAEL
=
3000
ppm
based
on
lower
body
weights/
body
weight
gains,
reduced
food
consumption
and
food
efficiency
and
increased
kidney
weights
in
males
870.3100
90
Day
oral
toxicity
rodents
44775402
(1999)
unacceptable/
guideline
0,
30,
300,
3000
ppm
(M/
F:
0,
1.90/
2.13,
20.4/
23.9
and
208.0/
236.0
mg/
kg/
day0
NOAEL
=
3000
ppm
(equivalent
to
208
mg/
kg/
day
in
males
and
236
mg/
kg/
day
in
females
LOAEL
cannot
be
defined
870.3150
90
Day
oral
toxicity
in
nonrodents
43928922
(1995)
acceptable/
nonguideline
0,
300,
500,
1000
or
2000
ppm
(M/
F:
0,
9/
10,
15.1/
17.2,
31.1/
31.5
or
62/
74
mg/
kg/
day)
NOAEL
=
2000
ppm
(M/
F:
62/
74
mg/
kg/
day)
LOAEL
=
not
established
870.3700a
Prenatal
developmental
in
rodents
43928925
(1995)
acceptable/
guideline
0,
5,
50,
500
or
1000
mg/
kg/
day
Maternal
NOAEL
=
50
mg/
kg/
day
LOAEL
=
500
mg/
kg/
day
based
on
increased
clinical
signs
of
toxicity,
decreased
body
weights/
body
weight
gains,
food
consumption
and
food
efficiency.
Developmental
NOAEL
=
1000
mg/
kg/
day
LOAEL
=
not
established
870.3700b
Prenatal
developmental
in
nonrodents
43928924
(1995)
acceptable/
guideline
0,
20,
100
or
500
mg/
kg/
day
Maternal
NOAEL
=
20
mg/
kg/
day
LOAEL
=
100
mg/
kg/
day
based
on
clinical
signs
of
toxicity
Developmental
NOAEL
=
500
mg/
kg/
day
LOAEL
=
not
established
Gene
Mutation
870.5100
Salmonella
&
Escherichia/
Mammali
an
Microsome
Mutagenicity
Test
43928927
(1995)
acceptable/
guideline
78.13
1250.0
ug/
plate
In
independently
performed
microbial
mutagenicity
assays,
Salmonella
typhimurium
TA1535,
TA1537,
TA98,
TA100
and
TA102
and
Escherichia
coli
WP2
uvrA
were
initially
exposed
to
312.5
5000.0
F
g/
plate
CGA
77102
technical
(95.6%)
in
the
presence
and
absence
of
S9
activation.
For
the
confirmatory
trial,
doses
of
78.13
1250.0
F
g/
plate
±S9
were
evaluated
with
S.
typhimurium
strains
TA1535,
TA1537,
TA100
and
TA102;
concentrations
of
312.5
5000.0
F
g/
plate
±S9
were
examined
with
S.
typhimurium
TA
98
and
E.
coli
WP2
uvrA.
In
general,
doses
$
1250.0
F
g/
plate
±S9
were
cytotoxic
for
S.
typhimurium
TA1535,
TA1537,
TA100
and
TA102
and
5000.0
F
g/
plate
±S9
was
slightly
cytotoxic
for
S.
typhimurium
TA98
and
E.
coli
WP2
uvrA.
There
was,
however,
no
indication
that
CGA77102
technical
induced
of
a
mutagenic
effect
in
any
tester
strain
either
in
the
presence
or
the
absence
of
S9
activation.
Guideline
No./
Study
Type
MRID
No.
(year)/
Classification
/Doses
Results
48
Cytogenetics
870.5395
Micronucleus
test
43928926
(1995)
acceptable/
guideline
500,
1000
or
2000
mg/
kg
Groups
of
five
male
and
five
female
Tif:
MAGf(
SPF)
mice
received
single
oral
gavage
administrations
of
500,
1000
or
2000
mg/
kg
CGA
77102
technical
(95.6%).
Toxic
signs,
similar
to
those
seen
in
the
preliminary
range
finding
studies
(i.
e.,
ataxia,
tremors
and/
or
hunched
posture)
were
recorded
for
high
dose
males
and
females
throughout
the
48
hour
postexposure.
No
bone
marrow
cytotoxicity
was
seen
at
any
dose
or
sacrifice
time.
The
positive
control
induced
the
expected
high
yield
of
MPEs
in
males
and
females.
There
was,
however,
no
evidence
that
CGA
77102
technical
induced
a
clastogenic
or
aneugenic
effect
in
either
sex
at
any
dose
or
sacrifice
time.
Other
Effects
870.5550
Unscheduled
DNA
synthesis
43928928
(1995)
acceptable/
guideline
500,
1500,
3200
(females),
5000
(males)
mg/
kg
Groups
consisting
of
three
to
four
rats
per
sex
received
single
oral
gavage
administrations
of
CGA
77102
Technical
(95.6%)
at
doses
of
500,
1500
or
5000
mg/
kg
(males)
or
500,
1500
or
3200
mg/
kg
(females).
Hepatocytes
harvested
at
15
and
38
hours
were
evaluated
for
viability
and
replicative
DNA
synthesis
(RDS).
For
the
UDS
determination,
additional
groups
(3/
sex/
dose)
were
exposed
to
500
or
1500
mg/
kg
and
the
recovered
hepatocytes
were
scored
at
2
or
15
hours
postexposure.
Two
of
four
females
in
the
3200
mg/
kg
group
and
2
of
4
males
in
the
5000
mg/
kg
group
died
prior
to
the
scheduled
sacrifice
at
38
hours.
Severe
cytotoxicity
was
seen
in
the
hepatocytes
recovered
from
1
of
2
surviving
males
and
both
female
survivors
in
the
highdose
groups.
Lower
levels
were
neither
toxic
to
the
animals
nor
cytotoxic
to
the
target
cells.
A
clear
dose
related
increase
in
the
percentage
of
cells
in
S
phase
(RDS)
was
obtained
from
hepatocytes
harvested
38
hours
posttreatment
of
the
male
rats.
The
response
ranged
from
a
5.3
fold
increase
at
1500
mg/
kg
to
a
16.1
fold
increase
at
the
high
dose
(5000
mg/
kg).
In
females,
a
marked
increase
in
RDS
was
initially
seen
at
1500
mg/
kg
but
the
response
declined
over
time
with
a
24.4
fold
increase
at
15
hours
and
a
12.2
fold
increase
at
38
hours.
There
was,
however,
no
evidence
that
the
CGA
77102
Technical
at
doses
of
500
or
1500
mg/
kg
induced
a
genotoxic
response
at
2
or
15
hours
posttreatment.
We
conclude,
therefore,
that
the
data
indicate
that
CGA
77102
Technical
was
negative
for
genotoxicity
but
positive
for
cellular
proliferation
when
tested
up
to
overtly
toxic
and
cytotoxic
doses
in
this
in
vivo/
in
vitro
rat
hepatocyte
RDS/
UDS
assay.
Guideline
No./
Study
Type
MRID
No.
(year)/
Classification
/Doses
Results
49
870.7485
Metabolism
and
pharmacokinetics
44491401
(1996)
acceptable/
guideline
single
dose
of
0.5
(group
B1)
or
100
mg/
kg
(group
D1)
radio
labeled
CGA77102
100
mg/
kg/
day
nonradio
labeled
CGA
77102
for
14
days
followed
by
0.5
mg/
kg
radio
labeled
CGA77102
(Group
V1);
single
dose
of
0.5
or
100
mg/
kg
radio
labeled
CGA
77102
for
bile
cannulation
study
In
all
three
dose
groups
(B1,
D1,
and
V1),
the
seven
day
combined
levels
of
radioactivity
in
urine
were
31.1
36.5%
for
males
and
40.8
45.5%
for
females;
the
fecal
levels
were
60.2
62.5%
for
males
and
48.9
55.0%
for
females.
Only
0.1%
or
less
was
eliminated
in
the
expired
air.
The
total
recovery
ranged
from
96.5
±
2.3%
to
99.3
±
0.9%.
The
route
or
extent
of
excretion
was
slightly
influenced
by
the
sex
of
the
animal
but
not
by
pretreatment
with
non
radio
labeled
CGA
77102
or
by
the
dose
level.
The
degree
of
absorption,
based
on
adding
the
cumulative
urinary
excretion
to
the
total
residues
in
tissues,
was
35
39%
in
males
and
43
49%
in
females
of
both
dose
groups.
However,
based
on
the
bile
duct
cannulation
study,
most
of
CGA
77102
was
absorbed
from
the
gastrointestinal
tract
since
85%
of
the
dose
was
recovered
in
urine,
bile
fluid,
and
tissues
during
the
48
hours
study
period.
Therefore,
the
biliary
excretion
and
enterohepatic
circulation
play
a
significant
role
in
the
elimination
process
of
CGA
77102.
Irrespective
of
the
dose
and
sex,
there
seems
to
be
a
biphasic
plasma
profile
with
two
concentration
maxima
(Cmax
);
a
fast
rising
first
Cmax
was
reached
at
0.25
1
hour
post
dosing
which
was
succeeded
by
a
second
Cmax
at
8
and
at
12
24
hours
following
administration
of
the
low
and
high
dose,
respectively.
In
the
low
dose
group
(B1),
the
first
and
second
Cmax
were
nearly
identical
(~
0.03
F
g/
ml);
in
the
high
dose
group
(D1),
the
first
and
second
Cmax
were,
respectively,
4.6
and
>3.9
F
g/
ml
in
males
and
2.2
and
4.5
F
g/
ml
in
females.
The
time
to
half
maximum
plasma
concentration
(tcmax/
2
)
in
males/
females
was
31/
24
hours
at
the
low
dose
and
44/
32
hours
at
the
high
dose.
Bioavailability,
or
the
area
under
the
plasma
concentration
curve
(AUC0
48hr
),
was
nearly
identical
(~
0.8
mg/
kg.
hr)
among
males
and
females
of
the
low
dose
group.
Also,
both
sexes
in
the
high
dose
group
had
similar
plasma
AUC0
48hr
(M/
F:
143/
125
mg/
kg.
hr)
which
increased
almost
proportionately
with
the
200
fold
increase
in
the
dose
level.
The
residues
in
RBC
increased
steadily
with
time
reaching
peak
levels
(at
24
48
hours
post
dosing)
of
0.5
0.6
and
90
ppm
(or
F
g/
g)
CGA
77102
equivalents
for
the
low
(B1)
and
high
(D1)
dose
groups,
respectively.
The
peak
levels
in
RBC
remained
high
and
were
nearly
20
fold
higher
than
the
respective
plasma
Cmax
levels.
Guideline
No./
Study
Type
MRID
No.
(year)/
Classification
/Doses
Results
50
The
kinetics
of
tissue
distribution
and
depletion
in
both
sexes
were
also
followed
for
up
to
144
hours
following
a
single
low
or
high
oral
dose
(Groups
F1
F4).
Peak
residue
levels
were
reached
within
12
24
hours
and
ranged
from
0.007
ppm
(female
muscle)
to
0.123
ppm
(male
kidneys)
at
the
low
dose,
and
from
1.29
ppm
(male
brain)
to
16.82
ppm
(male
liver)
at
the
high
dose,
with
the
highest
levels
being
among
some
of
the
well
perfused
tissues
(e.
g.,
liver,
kidneys,
spleen,
and
lungs).
The
extent
of
residue
depletion
was
variable
among
the
tissue
types
but
was
minimally
affected
by
the
dose
or
the
sex
of
the
animal.
The
radiolabel
was
most
persistent
in
some
of
the
well
perfused
organs
(e.
g.,
the
heart,
lungs,
and
spleen)
in
addition
to
the
brain
and
bone
where,
after
144
hours,
the
levels
were
decreased
to
only
45
94%
of
their
maximal
concentrations.
In
Groups
F1
F4,
peak
residue
concentration
in
the
whole
blood
(0.2
and
42
47
F
g/
ml
in
the
low
and
high
dose
groups,
respectively)
was
reached
at
24
hours
and
was
maintained
throughout
the
study.
Overall,
the
high/
low
dose
peak
tissue
levels
(including
blood)
ranged
from
132
to
282
which
approximates
the
200
fold
increase
in
dosage.
CGA
77102
has
a
high
affinity
for
and
a
long
half
life
in
blood
(especially
RBC)
which
might
contribute
to
the
retarded
depletion
of
tissue
residues.
Guideline
No./
Study
Type
MRID
No.
(year)/
Classification
/Doses
Results
51
870.7485
Metabolism
and
pharmacokinetics
44491402
(1996)
unacceptable/
guideline
single
dose
of
0.5
(group
B1)
or
100
mg/
kg
(group
D1)
radio
labeled
CGA77102
100
mg/
kg/
day
nonradio
labeled
CGA
77102
for
14
days
followed
by
0.5
mg/
kg
radio
labeled
CGA77102
(Group
V1);
single
dose
of
0.5
or
100
mg/
kg
radio
labeled
CGA
77102
for
bile
cannulation
study
(from
MRID
44491401)
single
oral
low
dose
(0.5
mg/
kg,
Group
B2)
of
[Phenyl
U
14
C]
CGA
24705
(R/
S
Metolachlor,
racemate)
The
72
hour
mean
recovery
of
radioactivity
in
urine,
feces,
and
carcass
following
administration
of
0.5
mg/
kg
of
[Phenyl
U
14
C]
CGA
24705
was
43.1%,
47.0%,
and
7.4%
in
males
and
54.0%,
39.4%,
and
4.1%
in
females,
respectively.
In
contrast,
both
sexes
excreted
more
of
the
label
in
the
feces
(M:
F
59.7%:
53.4%)
than
in
the
urine
(M:
F
29.4%:
39.8%)
during
the
same
period
following
administration
of
the
same
dose
of
[Phenyl
U
14
C]
CGA
77102
(the
S
enantiomer)
(MRID
44491401).
The
urinary
and
fecal
metabolite
profiles,
with
31
and
15
metabolite
fractions,
respectively,
were
qualitatively
similar
among
all
groups;
however,
there
were
large
quantitative
differences,
based
on
the
dosing
formulation,
on
one
hand,
and
the
sex
of
the
animal,
on
the
other.
Based
on
a
percentage
of
the
dose,
several
of
the
major
urinary
metabolite
fractions
(e.
g.,
U1,
U2,
U3,
U18,
U24,
and
U30)
were
more
abundant
in
the
case
of
the
racemicMetolachlor
(CGA
24705)
than
the
S
Metolachlor
(CGA
77102);
in
contrast,
several
fecal
metabolite
fractions
(e.
g.,
F9,
F10,
F12,
and
F13)
were
present
at
higher
levels
in
the
case
of
CGA
77102
than
CGA
24705.
On
the
other
hand,
there
were
sex
related
differences
regardless
of
the
dosing
formulation
where,
for
instance,
females
had
greater
urinary
concentrations
than
males
of
several
metabolite
fractions,
including
U3,
U4,
U8,
U9,
U18,
U20,
and
U30;
the
males,
however,
excreted
more
of
fractions
U1
and
U24
than
the
females.
Also,
several
fecal
fractions
including
F1,
F3,
F5,
F6,
F7,
F8,
and
F13
were
influenced
by
the
sex
regardless
of
the
dose
level
(e.
g.
B1
vs.
D1)
or
the
stereochemical
make
up
of
Metolachlor
(B1
vs.
B2).
Other
metabolite
fractions
were
dependent
on
both
the
sex
and
the
chemical
formulation
as,
for
instance,
in
the
case
of
metabolite
U2
which,
relative
to
the
opposite
sex
within
the
same
group,
was
more
abundant
in
the
urine
of
the
females
of
Group
B2
(CGA
24705)
and
in
the
urine
of
the
males
of
Group
B1
(CGA
77102).
The
bile
fluid
accounted
for
79.8%
of
the
administered
low
or
high
dose
of
CGA
77102
(Groups
G1
and
G2)
where
the
2D
TLC
showed
14
biliary
metabolite
fractions
(G1
G14)
in
the
high
dose
Group
and
only
six
metabolites
in
the
low
dose
Group.
The
two
metabolite
fractions
G7
and
G8
accounted,
respectively,
for
33.3%
and
9.6%
of
the
administered
low
dose
and
31.3%
and
14.6%
of
the
administered
high
dose.
Other
major
biliary
metabolites
were
G3,
G9,
and
G10
which
accounted
for
about
5%,
5
7%,
and
3
5%,
respectively,
of
either
dose
group.
Guideline
No./
Study
Type
MRID
No.
(year)/
Classification
/Doses
Results
52
The
results
clearly
show
that
the
metabolite
profile
in
excreta
and
bile
fluid
is
very
complex
and
that
Metolachlor
(racemate
or
Senantiomer
is
extensively
metabolized.
This
was
also
shown
earlier
by
another
rat
metabolism
study
on
the
absorption,
distribution,
excretion,
and
metabolite
identification
of
racemic
CGA
24705
(MRID
43164201,
reviewed
by
T.
McMahon,
HED
doc.
no.
010990
dated
May
23,
1994).
No
actual
metabolites
or
pathways
were
identified
in
the
current
study
and
there
were
no
data
to
support
or
refute
the
previous
findings
of
four
major
degradation
pathways
with
more
than
30
metabolites.
However,
knowing
the
enantiomeric
stereospecific
reactions/
metabolites
is
not
likely
to
help
in
making
comparative
risk
assessments
between
R/
S
Metolachlor
(CGA
24705)
and
S
Metolachlor
(CGA
77102)
since
the
contribution
of
each
metabolite
to
the
overall
toxicity
of
Metolachlor
is
not
well
understood.
Furthermore,
other
bridging
animal
studies
with
CGA
77102
should
highlight
possible
toxicity
differences
from
the
well
studied
CGA
24705
due
to
variations
in
the
metabolite
profiles.
The
Registrant
is
requested
to
comment
on
or
provide
information
on
a
number
of
issues
including:
1)
The
stereoisomeric
purity
of
CGA
24705
and
CGA
77102.
2)
The
adequacy
of
the
storage
conditions
and
the
validity
of
the
metabolite
profile
results
in
light
of
the
storage
related
results
variability.
3)
Explain
why,
relative
to
the
other
dosing
formulation,
some
metabolite
fractions
(e.
g.,
F10,
F12,
and
F13)
were
up
to
7
fold
higher
in
the
case
of
the
S
enantiomer
CGA77102
while
some
urinary
metabolite
fractions
(e.
g.,
U1,
U2,
and
U3)
were
up
to
4
fold
higher
in
the
case
of
CGA
24705.
4)
Provide
rational
for
dose
selection.
5)
The
Registrant
might
also
have
to
comment
on
the
possible
formation
and
the
level
of
methylethylaniline
from
either
dosing
formulation
and
the
possible
contribution
of
this
metabolite
to
the
carcinogenicity
of
Metolachlor.
This
issue
was
raised
earlier
by
T.
McMahon
(HED
document
no.
010990
dated
May
23,
1994)
and
might
need
to
be
followed
up
by
HED's
risk
assessors
who
are
in
charge
of
SMetolachlor
53
Appendix
A
Table
3:
Tolerance
Reassessment
Summary
for
Metolachlor
(PC
Code
108801)
Commodity
Current
Tolerance
(ppm)
a
Range
of
residues
(ppm)
Tolerance
Reassessment
(ppm)
Comment/
Correct
Commodity
Definition
Tolerances
listed
under
40
CFR
§180.368(
a):
Almond,
hulls
0.3
Data
were
not
available
for
review
(DNA)
TBD
Barley,
fodder
0.
5
Not
applicable
(NA)
Reassign
to
180.368(
d)
To
be
determined
(TBD)
Additional
data
are
required.
The
definition
for
fodder
should
be
changed
to
Barley,
straw
Barley,
grain
0.
1
Buckwheat,
grain
0.
1
Cabbage
1.0
NA
Revoke
Registered
uses
(SLNs)
on
cabbage
have
been
canceled.
Cattle,
fat
0.
02
Extrapolating
to
a
1x
feeding
level,
maximum
combined
residues
would
be
<0.011
ppm
in
fat,
<0.016
ppm
in
meat,
0.035
ppm
in
liver,
and
0.11
ppm
in
kidney.
0.04
Tolerances
for
fat,
meat,
and
meat
byproducts
(except
kidney)
should
be
set
at
the
method
LOQ
of
0.04
ppm.
The
tolerance
for
liver
should
be
revoked,
and
the
tolerance
for
kidney
should
remain
at
0.2
ppm.
Cattle,
kidney
0.
2
0.
20
Cattle,
liver
0.05
Revoke
Cattle,
meat
0.
02
0.
04
Cattle,
meat
byproducts
(exc.
liver
and
kidney)
0.02
0.04
Celery
0.1
NA
Revoke
Registered
uses
(SLNs)
on
celery
have
been
canceled.
Corn,
fodder
8.
0
field
(0.11
2.81)
sweet
(0.24
5.54)
6.0
Corn,
Stover.
The
available
metolachlor
residue
data
indicate
that
the
tolerance
can
be
lowered
to
6.0
ppm
Corn,
forage
8.0
field
(<
0.12
3.02)
sweet
(0.27
5.75)
6.0
The
available
metolachlor
residue
data
indicate
that
the
tolerance
can
be
lowered
to
6.0
ppm
Corn,
fresh
(inc.
sweet)
(K+
CWHR)
0.1
<0.08<
0.10
0.
10
Corn,
sweet
(K+
CWHR)
Corn,
grain
0.
1
<0.08
0.
10
Cotton,
undelinted
seed
0.1
<0.08
0.10
Egg
0.
02
Residues
were
not
detected
in
eggs
of
hens
dosed
at
up
to
5.7x
the
MTDB
0.04
The
tolerance
for
eggs
should
be
set
at
the
combined
LOQ
for
the
enforcement
method.
Goat,
fat
0.
02
See
cattle
above
0.04
See
cattle
above.
Goat,
kidney
0.
2
0.20
Goat,
liver
0.05
Revoke
Commodity
Current
Tolerance
(ppm)
a
Range
of
residues
(ppm)
Tolerance
Reassessment
(ppm)
Comment/
Correct
Commodity
Definition
54
Goat,
meat
0.02
0.04
Goat,
meat
byproducts
(exc.
liver
and
kidney)
0.02
0.04
Hog,
fat
0.
02
NA
Revoke
Based
on
the
results
of
the
ruminant
feeding
study
and
a
MTDB
for
swine
of
0.315
ppm,
there
is
no
reasonable
expectation
of
finding
quantifiable
residues
in
hog
tissues
[40
CFR
180.6(
a)(
3)].
Hog,
kidney
0.
2
Hog,
liver
0.05
Hog,
meat
0.02
Hog,
meat
byproducts
(exc.
liver
and
kidney)
0.02
Horse,
fat
0.
02
See
cattle
above
0.04
See
cattle
above.
Horse,
kidney
0.
2
0.20
Horse,
liver
0.05
Revoke
Horse,
meat
0.02
0.04
Horse,
meat
byproducts
(exc.
liver
and
kidney)
0.02
0.04
Legume
vegetables
group
foliage
(exc.
soybean
forage
and
hay)
15.0
forage
(0.44
11.5)
hay
(0.31
2.2)
15
Residue
data
for
forage
(vines)
reflect
a
60
day
PHI
and
residue
data
on
hay
reflect
at
120
day
PHI.
Milk
0.02
Extrapolating
to
a
1x
feeding
level,
maximum
combined
residues
in
milk
would
be
0.004
ppm
0.02
Millet,
fodder
0.
5
NA
Reassign
to
180.368(
d)
TBD
Additional
data
are
required.
The
definition
for
fodder
should
be
changed
to
millet,
straw.
Millet,
forage
0.
5
Millet,
grain
0.
1
Milo,
fodder
0.
5
NA
Revoke
Residues
on
milo
commodities
are
covered
by
tolerances
on
sorghum.
Milo,
forage
0.5
Milo,
grain
0.
1
Nongrass
animal
feed
(forage,
fodder,
straw,
hay)
group
3.0
forage
<0.08
0.54
hay
<0.08<
0.47
1.0
Reassign
to
180.368(
d)
The
available
alfalfa
and
clover
data
indicate
that
the
tolerance
can
be
reduced
to
1.0
ppm.
Commodity
Current
Tolerance
(ppm)
a
Range
of
residues
(ppm)
Tolerance
Reassessment
(ppm)
Comment/
Correct
Commodity
Definition
55
Oats,
fodder
0.5
NA
Reassign
to
180.368(
d)
TBD
Additional
data
are
required.
The
definition
for
fodder
should
be
changed
to
oats,
straw.
Oats,
forage
0.5
Oats,
grain
0.
1
Peanut
0.5
<0.08
0.19
0.20
Peanut,
nutmeats.
New
residue
data
indicate
that
the
tolerance
can
be
lowered
to
0.2
ppm.
Peanut,
forage
30.0
NA
Revoke
Peanut
forage
is
no
longer
listed
a
regulated
commodity
of
peanuts
Peanut,
hay
30.0
1.
04
16.5
20.0
New
residue
data
indicate
that
the
tolerance
can
be
lowered
to
20.0
ppm.
Peppers,
bell
0.1
<0.02
0.108
Revoke
Registered
uses
(SLNs)
on
peppers
have
been
canceled.
Potato
0.2
<0.08
0.14
0.20
Poultry,
fat
0.
02
Residues
were
not
detected
in
tissues
of
hens
dosed
at
up
to
5.7x
the
MTDB
0.04
Tolerances
for
poultry
tissues
should
be
set
at
the
combined
LOQ
for
the
enforcement
method,
and
the
separate
tolerance
for
liver
should
be
revoked.
Poultry,
liver
0.05
Revoke
Poultry,
meat
0.02
0.04
Poultry,
meat
byproducts
(exc.
liver)
0.02
0.04
Rice,
fodder
0.
5
NA
Reassign
to
180.368(
d)
TBD
Additional
data
are
required.
The
tolerance
for
rice
forage
should
be
revoked
as
it
is
not
a
regulated
commodity,
and
the
definition
for
fodder
should
be
changed
to
rice,
straw.
Rice,
forage
0.5
Revoke
Rice,
grain
0.
1
Reassign
to
180.368(
d)
TBD
Rye,
fodder
0.
5
NA
Reassign
to
180.368(
d)
TBD
Additional
data
are
required.
The
tolerance
for
rye
fodder
should
be
changed
to
rye,
straw.
Rye,
forage
0.5
Rye,
grain
0.
1
Safflower,
seed
0.1
<0.08
0.10
Commodity
Current
Tolerance
(ppm)
a
Range
of
residues
(ppm)
Tolerance
Reassessment
(ppm)
Comment/
Correct
Commodity
Definition
56
Seed
and
pod
vegetables
(exc.
soybean)
0.3
<0.08
0.44
0.50
Edible
podded
legume
vegetables
subgroup.
The
available
data
support
a
tolerance
of
0.5
ppm
on
this
subgroup.
<0.08<
0.11
0.
10
Dried
shelled
pea
and
bean
(except
soybean)
subgroup
The
available
data
support
a
tolerance
of
0.1
ppm
on
this
subgroup.
NA
TBD
Succulent
shelled
pea
and
bean
subgroup
Data
are
required
for
this
subgroup.
Sheep,
fat
0.
02
see
cattle
above
0.04
See
cattle
above
Sheep,
kidney
0.
2
0.20
Sheep,
liver
0.05
revoke
Sheep,
meat
0.02
0.04
Sheep,
meat
byproduct
(exc.
liver
and
kidney)
0.02
0.04
Sorghum
grain,
fodder
2.
0
<0.11
3.19
4.0
Sorghum
grain,
stover
The
available
data
support
increasing
the
tolerance
on
stover
to
4.0
ppm
and
decreasing
the
tolerance
on
forage
to
1.0
ppm
Sorghum
grain,
forage
2.0
<0.08
0.45
1.0
Sorghum
grain,
grain
0.
3
0.08
0.19
0.30
Soybean
0.2
<0.08<
0.18
0.
20
Soybean,
seed
Soybean,
forage
8.0
0.
15
4.37
5.0
The
available
data
indicate
that
the
tolerance
on
forage
can
be
lowered
to
5.0
ppm
Soybean,
hay
8.
0
0.38
6.90
8.0
Fruit,
stone,
group
0.1
<0.08
0.08
Revoke
The
registrant
no
longer
wishes
to
support
the
use
on
stone
fruits.
Nuts,
tree,
group
0.1
<0.08
0.08
0.10
Wheat,
fodder
0.
5
NA
Reassign
to
180.368(
d)
TBD
Additional
data
are
required.
The
definition
for
fodder
should
be
changed
to
wheat,
straw.
Wheat,
forage
0.5
Wheat,
grain
0.
1
Time
limited
Tolerances
Listed
under
40
CFR
§180.368(
b):
Commodity
Current
Tolerance
(ppm)
a
Range
of
residues
(ppm)
Tolerance
Reassessment
(ppm)
Comment/
Correct
Commodity
Definition
57
Grass,
forage
10.0
b
0.04
8.4
10
Permanent
tolerances
are
pending.
Grass,
hay
0.
2
b
<0.08
0.11
0.20
Spinach
0.3
b
<0.08
0.38
0.50
New
data
support
an
increased
permanent
tolerance
for
metolachlor
residues
of
0.5
ppm
in/
on
spinach
(PP#
8E5011).
Tomato
0.1
c
<0.08
0.08
0.10
New
data
support
a
permanent
tolerance
for
metolachlor
residues
of
0.1
ppm
in/
on
tomatoes
(PP#
6F4751).
Tomato,
puree
0.3
c
<0.10
Revoke
New
data
indicate
that
the
tolerances
for
metolachlor
residues
in/
on
tomato
paste
and
puree
are
not
necessary.
Tomato,
paste
0.
6
c
<0.10
Revoke
Tolerances
with
Regional
Registrations
Listed
under
40
CFR
§180.368(
c):
Onion,
dry
bulb
1.
0
<0.08<
0.43
ppm
Revoke
Registered
uses
(SLNs)
of
metolachlor
on
onions
and
various
peppers
have
been
canceled.
Pepper,
chili
0.5
<0.02
0.03
Revoke
Pepper,
tabasco
0.
5
0.09
0.45
Revoke
Pepper,
cubanelle
0.1
0.
03
0.04
Revoke
Tolerances
Needed
under
40
CFR
§180.368(
a)(
1):
Cotton,
gin
byproducts
None
0.08
3.2
4.
0
New
residue
data
indicates
that
a
tolerance
of
4.0
ppm
may
be
established.
Peanut,
meal
None
<3.85
0.
40
The
available
processing
data
indicates
that
residues
concentrate
in
presscake
(1.75x).
a
Expressed
in
terms
of
metolachlor
b
Time
limited
tolerances
on
grass
forage
and
hay
and
spinach
were
set
to
expire
on
12/
31/
01.
c
Time
limited
tolerances
on
tomato
commodities
are
set
to
expire
on
6/
30/
02.
d
Based
on
current
residue
data
for
peanuts,
additional
data
are
required
to
support
the
current
lower
use
rate.
58
Appendix
A
Table
4:
Tolerance
Reassessment
Summary
for
s
Metolachlor
(PC
Code
108800)
Commodity
Current
Tolerance
(ppm)
a
Range
of
residues
(ppm)
Tolerance
Reassessment
(ppm)
Comment/
Correct
Commodity
Definition
Tolerances
needed
under
40
CFR
§180.368(
a)(
2):
Cabbage
1.0
NA
TBD
Additional
data
are
required
to
support
the
use
of
S
metolachlor
on
cabbage
and
the
registrant
should
pursue
a
section
3
registration.
Cattle,
fat
0.
02
Extrapolating
to
a
1x
feeding
level,
maximum
combined
residues
would
be
<0.011
ppm
in
fat,
<0.016
ppm
in
meat,
0.035
ppm
in
liver,
and
0.11
ppm
in
kidney.
0.04
Tolerances
for
fat,
meat,
and
meat
byproducts
(except
kidney)
should
be
set
at
the
method
LOQ
of
0.04
ppm,
but
the
tolerance
for
kidney
should
remain
at
0.2
ppm.
Cattle,
kidney
0.
2
0.
20
Cattle,
meat
0.
02
0.
04
Cattle,
meat
byproducts
(exc.
kidney)
0.02
0.04
Celery
0.1
<0.08
0.10
The
available
metolachlor
data
support
a
tolerance
of
0.10
ppm
for
s
metolachlor.
Corn,
fodder
8.
0
field
(0.11
2.81)
sweet
(0.24
5.54)
6.0
Corn,
Stover.
The
available
metolachlor
residue
data
indicate
that
the
tolerance
can
be
lowered
to
6.0
ppm
Corn,
forage
8.0
field
(<
0.12
3.02)
sweet
(0.27
5.75)
6.0
The
available
metolachlor
residue
data
indicate
that
the
tolerance
can
be
lowered
to
6.0
ppm
Corn,
fresh
(inc.
sweet)
(K+
CWHR)
0.1
<0.08<
0.10
0.
10
Corn,
sweet
(K+
CWHR)
Supported
by
the
available
metolachlor
data.
Corn,
grain
0.
1
<0.08
0.
10
Corn,
Field,
grain.
Supported
by
the
available
metolachlor
data.
Cotton,
undelinted
seed
0.1
<0.08
0.10
Supported
by
the
available
metolachlor
data.
Cotton,
gin
byproducts
NA
0.08
3.2
4.
0
New
metolachlor
residue
data
indicates
that
a
tolerance
of
4.0
ppm
may
be
established.
Egg
0.
02
Residues
were
not
detected
in
eggs
of
hens
dosed
at
up
to
5.7x
the
MTDB
0.04
The
tolerance
for
eggs
should
be
set
at
the
combined
LOQ
for
the
enforcement
method.
Goat,
fat
0.
02
See
cattle
above
0.04
See
cattle
above
Goat,
kidney
0.
2
0.20
Commodity
Current
Tolerance
(ppm)
a
Range
of
residues
(ppm)
Tolerance
Reassessment
(ppm)
Comment/
Correct
Commodity
Definition
59
Goat,
meat
0.02
0.04
Goat,
meat
byproducts
(exc.
kidney)
0.02
0.04
Horse,
fat
0.
02
See
cattle
above
0.04
See
cattle
above.
Horse,
kidney
0.
2
0.20
Horse,
meat
0.02
0.04
Horse,
meat
byproducts
(exc.
kidney)
0.02
0.04
Legume
vegetables
group
foliage
(exc.
soybean
forage
and
hay)
15.0
forage
(0.44
11.5)
hay
(0.31
2.2)
15
Residue
data
for
forage
(vines)
reflect
a
60
day
PHI
and
residue
data
on
hay
reflect
at
120
day
PHI.
Milk
0.02
Extrapolating
to
a
1x
feeding
level,
maximum
combined
residues
in
milk
would
be
0.004
ppm
0.02
Peanut
0.5
<0.09
0.20
Peanut,
nutmeats.
New
metolachlor
residue
data
indicate
that
the
tolerance
can
be
lowered
to
0.2
ppm.
Peanut,
hay
30.0
4.19
20.0
New
metolachlor
residue
data
indicate
that
the
tolerance
can
be
lowered
to
20.0
ppm.
Peppers,
bell
0.1
<0.02
0.108
TBD
Additional
data
are
required
for
a
general
tolerance
on
peppers.
Potato
0.2
<0.08
0.14
0.20
Supported
by
the
available
metolachlor
data.
Poultry,
fat
0.
02
Residues
were
not
detected
in
tissues
of
hens
dosed
at
up
to
5.7x
the
MTDB
0.04
Tolerances
for
poultry
tissues
should
be
set
at
the
combined
LOQ
for
the
enforcement
method,
and
the
separate
tolerance
for
liver
should
be
revoked.
Poultry,
meat
0.02
0.04
Poultry,
meat
byproducts
(exc.
liver)
0.02
0.04
Safflower,
seed
0.1
<0.08
0.10
Supported
by
the
available
metolachlor
data.
Commodity
Current
Tolerance
(ppm)
a
Range
of
residues
(ppm)
Tolerance
Reassessment
(ppm)
Comment/
Correct
Commodity
Definition
60
Seed
and
pod
vegetables
(exc.
soybean)
0.3
<0.08
0.44
0.50
Edible
podded
legume
vegetables
subgroup.
The
available
data
support
a
tolerance
of
0.5
ppm
on
this
subgroup.
<0.08<
0.11
0.
10
Dried
shelled
pea
and
bean
(except
soybean)
subgroup
The
available
data
support
a
tolerance
of
0.1
ppm
on
this
subgroup.
NA
TBD
Succulent
shelled
pea
and
bean
subgroup
Data
are
required
for
this
subgroup.
Sheep,
fat
0.
02
see
cattle
above
0.04
See
cattle
above
Sheep,
kidney
0.
2
0.20
Sheep,
meat
0.02
0.04
Sheep,
meat
byproducts
(exc.
kidney)
0.02
0.04
Sorghum
grain,
fodder
2.
0
<0.11
3.19
4.0
Sorghun,
stover.
The
available
data
support
increasing
the
tolerance
on
stover
to
4.0
ppm
and
decreasing
the
tolerance
on
forage
to
1.0
ppm
Sorghum
grain,
forage
2.0
<0.08
0.45
1.0
Sorghum
grain,
grain
0.
3
0.08
0.19
0.30
Soybean
0.2
<0.08<
0.18
0.
20
Soybean,
seed.
Supported
by
the
available
metolachlor
and
s
metolachlor
data.
Soybean,
forage
8.0
0.
15
4.37
5.0
The
available
metolachlor
data
indicate
that
the
tolerance
on
forage
can
be
lowered
to
5.0
ppm.
Soybean,
hay
8.
0
0.38
6.90
8.0
Soybean,
hulls
None
<0.14
None
New
s
metolachlor
data
indicate
that
s
metolachlor
residues
in/
on
soybean
hulls
will
not
exceed
the
established
tolerance
on
soybean
seeds.
Time
limited
Tolerances
needed
under
40
CFR
§180.368(
b)(
2):
Commodity
Current
Tolerance
(ppm)
a
Range
of
residues
(ppm)
Tolerance
Reassessment
(ppm)
Comment/
Correct
Commodity
Definition
61
Grass,
forage
10.0
b
0.04
8.4
10
Permanent
tolerances
are
pending.
Grass,
hay
0.
2
b
<0.08
0.11
0.20
Spinach
0.3
b
<0.08
0.38
0.50
New
metolachlor
data
support
an
increased
permanent
tolerance
for
s
metolachlor
residues
of
0.5
ppm
in/
on
spinach.
Tomato
0.1
c
<0.08
0.08
0.10
New
metolachlor
data
support
a
permanent
tolerance
for
smetolachlor
residues
of
0.1
ppm
in/
on
tomatoes.
Tomato,
puree
0.3
c
<0.10
revoke
New
metolachlor
residue
data
indicate
that
the
tolerances
for
s
metolachlor
residues
in/
on
tomato
paste
and
puree
are
not
necessary.
Tomato,
paste
0.
6
c
<0.10
revoke
Tolerances
with
Regional
Registrations
needed
under
40
CFR
§180.368(
c)(
2):
Onion,
dry
bulb
1.
0
<0.08<
0.43
ppm
0.50
The
available
metolachlor
residue
data
support
lowering
the
tolerance
to
0.
5
ppm;
however,
additional
data
are
required
to
support
the
use
of
s
metolachlor
and
the
registrant
should
pursue
a
section
3
registration.
Pepper,
chili
0.5
<0.02
0.03
0.10
With
the
exception
of
chili
peppers,
the
available
residue
data
support
the
current
tolerances.
Tolerances
for
chili
peppers
could
be
lowered
to
0.1
ppm.
If
a
general
tolerance
on
peppers
is
established
at
0.5
ppm,
than
these
separate
tolerances
should
be
revoked.
Pepper,
tabasco
0.
5
0.09
0.45
0.50
Pepper,
cubanelle
0.1
0.
03
0.04
0.10
Tolerances
Needed
under
40
CFR
§180.368(
d)(
2):
Barley,
grain
0.
5
NA
TBD
Additional
data
are
required.
Barley,
hay
None
Barley,
straw
0.
1
Buckwheat,
grain
0.
1
NA
TBD
Additional
data
are
required
Millet,
forage
0.
5
NA
TBD
Additional
data
are
required.
Millet,
grain
0.
1
Millet,
hay
None
Commodity
Current
Tolerance
(ppm)
a
Range
of
residues
(ppm)
Tolerance
Reassessment
(ppm)
Comment/
Correct
Commodity
Definition
62
Millet,
straw
0.
5
Nongrass
animal
feed
(forage,
fodder,
straw,
hay)
group
3.0
forage
<0.08
0.54
hay
<0.08<
0.47
1.0
The
available
alfalfa
and
clover
data
indicate
that
the
tolerance
can
be
reduced
to
1.0
ppm.
Oats,
forage
0.5
NA
TBD
Additional
data
are
required.
Oats,
grain
0.
1
Oats,
hay
None
Oats,
straw
0.5
Peanut,
meal
None
<3.85
0.
40
The
available
metolachlor
processing
data
indicates
that
residues
concentrate
in
presscake
(1.75x).
Rice,
grain
0.
1
NA
TBD
Additional
data
are
required.
Rice,
straw
0.
5
Rye,
forage
0.5
NA
TBD
Additional
data
are
required.
Rye,
grain
0.1
Rye,
straw
0.
5
Wheat,
forage
0.5
NA
TBD
Additional
data
are
required.
Wheat,
grain
0.
1
Wheat,
hay
None
Wheat,
straw
0.
5
a
Expressed
in
terms
of
s
metolachlor
b
Time
limited
tolerances
on
grass
forage
and
hay
and
spinach
were
set
to
expire
on
12/
31/
01.
c
Time
limited
tolerances
on
tomato
commodities
are
set
to
expire
on
6/
30/
02.
| epa | 2024-06-07T20:31:43.283664 | regulations | {
"license": "Public Domain",
"url": "https://downloads.regulations.gov/EPA-HQ-OPP-2002-0223-0020/content.txt"
} |
EPA-HQ-OPP-2002-0224-0001 | Rule | "2002-09-19T04:00:00" | Diflubenzuron; Pesticide Tolerance | 59006
Federal
Register
/
Vol.
67,
No.
182
/
Thursday,
September
19,
2002
/
Rules
and
Regulations
now
state:
``
Clean
Air
Act
Redesignation
and
Reclassification,
Searles
Valley
Nonattainment
Area;
Designation
of
Coso
Junction,
Indian
Wells
Valley,
and
Trona
Nonattainment
Areas;
California;
Determination
of
Attainment
of
the
PM
10
Standards
for
the
Trona
Area;
Particulate
Matter
of
10
microns
or
less
(
PM
10).''
Under
Executive
Order
12866
(
58
FR
51735,
October
4,
1993),
this
action
is
not
a
``
significant
regulatory
action''
and
is
therefore
not
subject
to
review
by
the
Office
of
Management
and
Budget.
In
addition,
this
action
does
not
impose
any
enforceable
duty
or
contain
any
unfunded
mandate
as
described
in
the
Unfunded
Mandates
Reform
Act
of
1995
(
Public
Law
104
4),
or
require
prior
consultation
with
State
officials
as
specified
by
Executive
Order
12875
(
58
FR
58093,
October
28,
1993),
or
involve
special
consideration
of
environmental
justice
related
issues
as
required
by
Executive
Order
12898
(
59
FR
7629,
February
16,
1994).
Because
this
action
is
not
subject
to
notice
and
comment
requirements
under
the
Administrative
Procedure
Act
or
any
other
statute,
it
is
not
subject
to
the
provisions
of
the
Regulatory
Flexibility
Act
(
5
U.
S.
C.
601
et
seq.).
Under
5
U.
S.
C.
801(
a)(
1)(
A)
as
added
by
the
Small
Business
Regulatory
Enforcement
Fairness
Act
of
1996,
EPA
submitted
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
General
Accounting
Office
prior
to
publication
of
this
rule
in
today's
Federal
Register.
This
rule
is
not
a
``
major
rule''
as
defined
by
5
U.
S.
C.
804(
2).
List
of
Subjects
in
40
CFR
Part
81
Environmental
protection,
Air
pollution
control,
National
parks,
Wilderness
areas.
Dated:
September
9,
2002.
Wayne
Nastri,
Regional
Administrator,
Region
IX.
[
FR
Doc.
02
23730
Filed
9
18
02;
8:
45
am]
BILLING
CODE
6560
50
P
ENVIRONMENTAL
PROTECTION
AGENCY
40
CFR
Part
180
[
OPP
2002
0224;
FRL
7200
4]
Diflubenzuron;
Pesticide
Tolerances
AGENCY:
Environmental
Protection
Agency
(
EPA).
ACTION:
Final
rule.
SUMMARY:
This
regulation
establishes
tolerances
for
the
combined
residues
of
the
insecticide
diflubenzuron
(
N[[
4
chlorophenyl)
amino]
carbonyl]
2,6
difluorobenzamide)
and
its
metabolites,
4
chlorophenylurea
(
CPU)
and
4
chloroaniline
(
PCA)
in
or
on
the
following
raw
agricultural
commodities:
Grass,
forage,
fodder,
and
hay
group
17
at
6.0
ppm;
pepper
at
1.0
ppm;
stone
fruit
group
12
(
except
cherries)
at
0.07
ppm;
nut,
tree,
group
14
at
0.06
ppm;
almond,
hulls
at
6.0
ppm;
pistachio
at
0.06
ppm;
cattle,
meat
byproducts
at
0.15
ppm;
goat,
meat
byproducts
at
0.15
ppm;
hog,
meat
byproducts
at
0.15
ppm;
horse,
meat
byproducts
at
0.15
ppm;
sheep,
meat
byproducts
at
0.15
ppm.
This
regulation
is
increasing
the
tolerance
level
for
meat
byproducts
of
cattle,
goat,
hog,
horse,
and
sheep.
This
regulation
is
also
changing
the
tolerance
on
pasture
grass
to
grass,
forage,
fodder,
and
hay
group
17.
Interregional
Research
Project
Number
4
(
IR
4),
and
Uniroyal
Chemical
Company
requested
these
tolerances
under
the
Federal
Food,
Drug,
and
Cosmetic
Act,
as
amended
by
the
Food
Quality
Protection
Act
of
1996.
DATES:
This
regulation
is
effective
September
19,
2002.
Objections
and
requests
for
hearings,
identified
by
docket
control
number
OPP
2002
0224,
must
be
received
on
or
before
November
18,
2002.
ADDRESSES:
Written
objections
and
hearing
requests
may
be
submitted
by
mail,
in
person,
or
by
courier.
Please
follow
the
detailed
instructions
for
each
method
as
provided
in
Unit
VI.
of
the
SUPPLEMENTARY
INFORMATION.
To
ensure
proper
receipt
by
EPA,
your
objections
and
hearing
requests
must
identify
docket
control
number
OPP
2002
0224
in
the
subject
line
on
the
first
page
of
your
response.
FOR
FURTHER
INFORMATION
CONTACT:
By
mail:
Rita
Kumar,
Registration
Division
(
7505C),
Office
of
Pesticide
Programs,
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460;
telephone
number:
(
703)
308
8291;
e
mail
address:
kumar.
rita@
epa.
gov.
SUPPLEMENTARY
INFORMATION:
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:
Categories
NAICS
codes
Examples
of
potentially
affected
entities
Industry
111
112
311
32532
Crop
production
Animal
production
Food
manufacturing
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
the
table
could
also
be
affected.
The
North
American
Industrial
Classification
System
(
NAICS)
codes
have
been
provided
to
assist
you
and
others
in
determining
whether
or
not
this
action
might
apply
to
certain
entities.
If
you
have
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
Additional
Information,
Including
Copies
of
this
Document
and
Other
Related
Documents?
1.
Electronically.
You
may
obtain
electronic
copies
of
this
document,
and
certain
other
related
documents
that
might
be
available
electronically,
from
the
EPA
Internet
Home
Page
at
http://
www.
epa.
gov/.
To
access
this
document,
on
the
Home
Page
select
``
Laws
and
Regulations'',
``
Regulations
and
Proposed
Rules,''
and
then
look
up
the
entry
for
this
document
under
the
``
Federal
Register
Environmental
Documents.''
You
can
also
go
directly
to
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.
2.
In
person.
The
Agency
has
established
an
official
record
for
this
action
under
docket
control
number
OPP
2002
0224.
The
official
record
consists
of
the
documents
specifically
referenced
in
this
action,
and
other
information
related
to
this
action,
including
any
information
claimed
as
Confidential
Business
Information
(
CBI).
This
official
record
includes
the
documents
that
are
physically
located
in
the
docket,
as
well
as
the
documents
that
are
referenced
in
those
documents.
The
public
version
of
the
official
record
does
not
include
any
information
claimed
as
CBI.
The
public
version
of
VerDate
Sep<
04>
2002
14:
40
Sep
18,
2002
Jkt
197001
PO
00000
Frm
00046
Fmt
4700
Sfmt
4700
E:\
FR\
FM\
19SER1.
SGM
19SER1
59007
Federal
Register
/
Vol.
67,
No.
182
/
Thursday,
September
19,
2002
/
Rules
and
Regulations
the
official
record,
which
includes
printed,
paper
versions
of
any
electronic
comments
submitted
during
an
applicable
comment
period
is
available
for
inspection
in
the
Public
Information
and
Records
Integrity
Branch
(
PIRIB),
Rm.
119,
Crystal
Mall
#
2,
1921
Jefferson
Davis
Hwy.,
Arlington,
VA,
from
8:
30
a.
m.
to
4
p.
m.,
Monday
through
Friday,
excluding
legal
holidays.
The
PIRIB
telephone
number
is
(
703)
305
5805.
II.
Background
and
Statutory
Findings
In
the
Federal
Register
of
December
14,
2001
(
66
FR
64823)
(
6813
2),
EPA
issued
a
notice
pursuant
to
section
408
of
the
Federal
Food,
Drug,
and
Cosmetic
Act
(
FFDCA),
21
U.
S.
C.
346a,
as
amended
by
the
Food
Quality
Protection
Act
of
1996
(
FQPA)
(
Public
Law
104
170),
announcing
the
filing
of
pesticide
petitions
(
PP
1E6347
and
1F6235)
by
Interregional
Research
Project
Number
4
(
IR
4),
and
Uniroyal
Chemical
Company
Inc.,
681
US
Highway
1
South,
North
Brunswick,
NJ
08902,
and
Middlebury,
CT
06749.
This
notice
included
a
summary
of
the
petitions
prepared
by
IR
4
and
Uniroyal
Chemical
Company,
the
registrants.
There
were
no
comments
received
in
response
to
the
notice
of
filing.
The
petitions
requested
that
40
CFR
180.377
be
amended
by
establishing
a
tolerance
for
the
combined
residues
of
the
insecticide
diflubenzuron
(
N[[
4
chlorophenyl)
amino]
carbonyl]
2,6
difluorobenzamide)
and
its
metabolites,
4
chlorophenylurea
(
CPU)
and
4
chloroaniline
(
PCA),
in
or
on
grass,
forage,
fodder,
and
hay,
group
17
at
6.0
part
per
million
(
ppm);
pepper
at
1.0
ppm;
stone
fruit
group
(
except
cherries)
at
0.05
ppm;
tree
nut
group
at
0.05
ppm;
almond,
hulls
at
5.0
ppm;
pistachio
at
0.05
ppm;
and
meat
byproducts
at
0.15
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)
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)
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
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),
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),
for
a
tolerance
for
residues
of
the
insecticide
diflubenzuron
(
N[[
4
chlorophenyl)
amino]
carbonyl]
2,6
difluorobenzamide)
and
its
metabolites,
4
chlorophenylurea
(
CPU)
and
4
chloroaniline
(
PCA)
on
grass,
forage,
fodder,
and
hay
group
at
6.0
ppm;
pepper
at
1.0
ppm;
stone
fruit
group
(
except
cherries)
at
0.07
ppm;
tree
nut
group
at
0.06
ppm;
almond
hulls
at
6.0
ppm;
pistachio
at
0.06
ppm;
cattle,
meat
byproducts
at
0.15
ppm;
goat,
meat
byproducts
at
0.15
ppm;
hog,
meat
byproducts
at
0.15
ppm;
horse,
meat
byproducts
at
0.15
ppm;
sheep,
meat
byproducts
at
0.15
ppm.
EPA's
assessment
of
exposures
and
risks
associated
with
establishing
the
tolerances
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
diflubenzuron
are
discussed
in
the
following
Table
1
as
well
as
the
no
observed
adverse
effect
level
(
NOAEL)
and
the
lowest
observed
adverse
effect
level
(
LOAEL)
from
the
toxicity
studies
reviewed.
TABLE
1.
SUBCHRONIC,
CHRONIC,
AND
OTHER
TOXICITY
Guideline
No.
Study
Type
Results
870.3100
90
Day
oral
toxicity
rodents
NOAEL
<
8
mg/
kg/
day
LOAEL
=
8
mg/
kg/
day
based
on
increased
methemoglobinemia,
and
signs
of
hemolytic
anemia,
erythrocyte
destruction
in
the
spleen
and
liver
and
regeneration
of
erythrocytes
in
the
bone
marrow.
870.3150
90
Day
oral
toxicity
in
nonrodents
NOAEL
=
2
mg/
kg/
day
LOAEL
=
6.24
mg/
kg/
day
based
on
methemoglobinemia.
870.3200
21/
28
Day
dermal
toxicity
NOAEL
=
500
mg/
kg/
day
LOAEL
=
1,000
mg/
kg/
day
based
on
methemoglobinemia
(
limit
dose).
870.3465
28
Day
inhalation
toxicity
NOAEL
=
20.3
mg/
kg/
day
highest
dose
tested
(
HDT)
LOAEL
was
not
established.
870.3700
Prenatal
developmental
in
rodents
Maternal
NOAEL
=
1,000
mg/
kg/
day
(
Limit
Dose)
LOAEL
was
not
established.
Developmental
NOAEL
=
1,000
mg/
kg/
day
(
Limit
Dose)
LOAEL
was
not
established.
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Regulations
TABLE
1.
SUBCHRONIC,
CHRONIC,
AND
OTHER
TOXICITY
Continued
Guideline
No.
Study
Type
Results
870.3700
Prenatal
developmental
in
nonrodents
Maternal
NOAEL
=
1,000
mg/
kg/
day
(
Limit
Dose)
LOAEL
was
not
established.
Developmental
NOAEL
=
1,000
mg/
kg/
day
(
Limit
Dose)
LOAEL
was
not
established.
870.3800
Reproduction
and
fertility
effects
Parental/
Systemic
NOAEL
<
36
mg/
kg/
day
(
LDT)
LOAEL
=
36
mg/
kg/
day
based
on
dose
related
decreased
hematocrit,
hemoglobin
concentration,
red
blood
cell
count
and
an
increase
in
percent
methemoglobin,
changes
in
cell
morphology
and
brown
pigment
in
Kupffer
cells.
Reproductive
NOAEL>
4254
mg/
kg/
day
(
HDT)
LOAEL
was
not
established.
Offspring
NOAEL
=
427
mg/
kg/
day
LOAEL
=
4254
mg/
kg/
day
based
on
Significant
decrease
in
F
1
pup
weights
on
day
4,
8
and
21
of
lactation.
870.4100
Chronic
toxicity
dogs
NOAEL
=
2
mg/
kg/
day
LOAEL
=
10
mg/
kg/
day
based
on
methemoglobinemia
and
sulfhemoglobinemia.
870.4200
Carcinogenicity
rats
NOAEL
was
not
established
LOAEL
=
7.8
mg/
kg/
day
based
on
histological
evidence
of
erythrocyte
destruction
and
compensatory
regeneration.
No
evidence
of
carcinogenicity
870.4300
Carcinogenicity
mice
NOAEL
=
2.4
mg/
kg/
day
LOAEL
=
12
mg/
kg/
day
based
on
increased
methemoglobin
and
sulfhemoglobin
levels.
No
evidence
of
carcinogenicity
870.5100
Gene
Mutation
Salmonella
strains
TA98,
TA100,
TA1535,
TA1537
and
TA1538
exposed
to
diflubenzuron
in
DMSO
at
doses
of
0
to
1,000
µ
g/
plate
both
in
the
presence
and
absence
of
S9
did
not
induce
mutations.
870.5375
Cytogenetics
Chinese
hamster
ovary
cells
in
vitro
exposure
to
diflubenzuron
in
DMSO
at
dose
levels
of
200
to
250
µ
g/
mL
both
in
the
presence
and
absence
of
S9
did
not
induce
an
increase
in
chromosomal
aberrations.
870.5550
Other
Effects
In
the
UDS
assay
primary
rat
hepatocytes
exposed
to
diflubenzuron
in
DMSO
at
dose
levels
of
0.1
to
333
µ
g/
mL
did
not
induce
unscheduled
DNA
syntheses.
870.7485
Metabolism
and
pharmacokinetics
[
14C
anilino]
diflubenzuron
was
completely
absorbed
and
87%
of
radioactivity
was
recovered
in
the
urine
and
feces
as
parent,
diflubenzuron
by
96
hours
post
dosing.
Diflubenzuron
did
not
metabolize
to
4
chloroaniline
(
CPA),
or
chlorophenylurea
(
CPU);
the
former
was
associated
with
methemoglobin
formation
and
tumor
formation
in
rats
and
mice
in
the
NTP
study.
[
U
14C
phenyl]
chlorophenylurea
(
CPU)
was
completely
absorbed
and
91%
of
the
dose
was
eliminated
in
urine
and
feces
by
144
hours.
Unmetabolized
CPU
was
not
identified
in
urine
or
feces.
Most
of
urinary/
fecal
metabolites
were
sulfate
or
glucuronide
conjugates
of
CPU.
870.7600
Dermal
penetration
Dermal
application
of
14C)
diflubenzuron
at
either
0.005
or
0.05
mg/
cm.
sq.
resulted
in
less
than
0.5%
absorption
at
any
dose
level
after
1,
4
or
10
hours
of
exposure.
N/
A
Special
studies
In
acute
oral
toxicity
study
in
rats
CPA
at
62
mg/
kg
caused
significant
increase
in
methemoglobinemia
while
CPU
at
200
mg/
kg
did
not
cause
methemoglobinemia.
B.
Toxicological
Endpoints
The
dose
at
which
the
NOAEL
from
the
toxicology
study
identified
as
appropriate
for
use
in
risk
assessment
is
used
to
estimate
the
toxicological
level
of
concern
(
LOC).
However,
the
lowest
dose
at
which
the
LOAEL
is
sometimes
used
for
risk
assessment
if
no
NOAEL
was
achieved
in
the
toxicology
study
selected.
An
uncertainty
factor
(
UF)
is
applied
to
reflect
uncertainties
inherent
in
the
extrapolation
from
laboratory
animal
data
to
humans
and
in
the
variations
in
sensitivity
among
members
of
the
human
population
as
well
as
other
unknowns.
An
UF
of
100
is
routinely
used,
10X
to
account
for
interspecies
differences
and
10X
for
intra
species
differences.
The
FQPA
Safety
Factor
Committee
(
SFC)
recommended
that
the
FQPA
safety
factor
used
in
human
health
risk
assessments
(
as
required
by
FQPA
of
August
3,
1996)
be
removed
(
reduced
to
1x)
in
assessing
the
risk
posed
by
this
chemical.
Consequently,
the
current
cRfD
and
cPAD
values
are
equivalent
(
0.02
mg/
kg/
day).
This
decision
was
based
on
the
following:
1.
There
is
no
indication
of
quantitative
or
qualitative
increased
susceptibility
of
rats
or
rabbits
to
in
utero
or
postnatal
exposure;
2.
A
developmental
neurotoxicity
study
(
DNT)
with
diflubenzuron
is
not
required;
3.
Food
and
drinking
water
exposure
assessments
will
not
underestimate
the
potential
exposure
for
infants
and
children;
and
4.
There
are
currently
no
registered
or
proposed
residential
(
non
occupational)
uses
of
diflubenzuron.
Although
there
are
no
registered
homeowner
uses,
there
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is
potential
for
professional
applications
to
outdoor
residential
and
recreational
areas
to
control
mosquitos,
moths,
and
other
insects.
However,
the
potential
for
post
application
residential
exposures
are
expected
to
be
limited.
Due
to
the
low
dermal
absorption
rate
(
0.5%)
of
diflubenzuron,
and
since
it
is
only
applied
to
the
tree
canopy,
minimal
bystander
contact
is
expected.
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
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
Safety
Factor.
For
non
dietary
risk
assessments
(
other
than
cancer)
the
UF
is
used
to
determine
the
LOC.
For
example,
when
100
is
the
appropriate
UF
(
10X
to
account
for
interspecies
differences
and
10X
for
intraspecies
differences)
the
LOC
is
100.
To
estimate
risk,
a
ratio
of
the
NOAEL
to
exposures
(
margin
of
exposure
(
MOE)
=
NOAEL/
exposure)
is
calculated
and
compared
to
the
LOC.
The
linear
default
risk
methodology
(
Q*)
is
the
primary
method
currently
used
by
the
Agency
to
quantify
carcinogenic
risk.
The
Q*
approach
assumes
that
any
amount
of
exposure
will
lead
to
some
degree
of
cancer
risk.
A
Q*
is
calculated
and
used
to
estimate
risk
which
represents
a
probability
of
occurrence
of
additional
cancer
cases
(
e.
g.,
risk
is
expressed
as
1
x
10
6
or
one
in
a
million).
Under
certain
specific
circumstances,
MOE
calculations
will
be
used
for
the
carcinogenic
risk
assessment.
In
this
non
linear
approach,
a
``
point
of
departure''
is
identified
below
which
carcinogenic
effects
are
not
expected.
The
point
of
departure
is
typically
a
NOAEL
based
on
an
endpoint
related
to
cancer
effects
though
it
may
be
a
different
value
derived
from
the
dose
response
curve.
To
estimate
risk,
a
ratio
of
the
point
of
departure
to
exposure
(
MOEcancer
=
point
of
departure/
exposures)
is
calculated.
A
summary
of
the
toxicological
endpoints
for
diflubenzuron
and
its
metabolites
used
for
human
risk
assessment
is
shown
in
the
following
Table
2:
TABLE
2.
SUMMARY
OF
TOXICOLOGICAL
DOSE
AND
ENDPOINTS
FOR
DIFLUBENZURON
AND
ITS
METABOLITES
FOR
USE
IN
HUMAN
RISK
ASSESSMENT1.
Exposure
Scenario
Dose
Used
in
Risk
Assessment
UF
FQPA
SF**
and
LOC
for
Risk
Assessment
Study
and
Toxicological
Effects
Acute
Dietary
all
populations
Not
Applicable
Not
Applicable
No
appropriate
endpoint
attributable
to
single
exposure
was
available
in
oral
studies.
Therefore
a
risk
assessment
is
not
required.
Chronic
Dietary
(
All
populations)
NOAEL=
2
mg/
kg/
day
UF
=
100
Chronic
RfD
=
0.02
mg/
kg/
day
FQPA
SF
=
1x
cPAD
=
chronic
RfD/
FQPA
SF
=
0.02
mg/
kg/
day
Chronic
Toxicity
Study
Dog
LOAEL
=
10
mg/
kg/
day
based
on
methemoglobinemia
and
sulfhemoglobinemia
Short
and
Intermediate
Term
Incidental
Oral
(
1
day
6
months)
(
Residential)
Not
applicable
Not
applicable
These
endpoints
were
not
evaluated.
There
are
no
registered
uses
of
diflubenzuron
which
result
in
significant
residential
exposure.
Short
Term
Dermal
(
1
30
days)
(
Occupational)
NOAEL
=
500
mg/
kg/
day
LOC
for
MOE
=
100
21
Day
dermal
rat
LOAEL
=
1,000
mg/
kg/
day
based
on
methemoglobinemia
Intermediate
Term
Dermal
(
1
6
months)
(
Occupational)
NOAEL
=
2
mg/
kg/
day
LOC
for
MOE
=
100
13
week
oral
dog
LOAEL
=
6.4
mg/
kg/
day
based
on
methemoglobinemia
Long
Term
Dermal
(
Longer
than
6
months)
(
Occupational)
NOAEL
=
2
mg/
kg/
day
LOC
for
MOE
=
100
Chronic
Toxicity
Study
Dog
LOAEL
=
10
mg/
kg/
day
based
on
methemoglobinemia
and
sulfhemoglobinemia
Short
Term
Inhalation
(
1
30
days)
(
Occupational)
NOAEL
=
20.302
mg/
kg/
day
LOC
for
MOE
=
100
28
day
Inhalation
Toxicity
Study
Rat/
21
day
Inhalation
Toxicity
Study
Rat
LOAEL
=
0.12
mg/
L
based
on
methemoglobinemia
(
21
day
study)
Intermediate
Term
Inhalation
(
1
6
months)
(
Occupational)
NOAEL
=
20.302
mg/
kg/
day
LOC
for
MOE
=
100
28
day
Inhalation
Toxicity
Study
Rat/
21
day
Inhalation
Toxicity
Study
Rat
LOAEL
=
0.12
mg/
L
based
on
methemoglobinemia
(
21
day
study)
Long
Term
Inhalation
(
Longer
than
6
months)
(
Occupational)
NOAEL
=
2
mg/
kg/
day
LOC
for
MOE
=
100
(
Occupational
Chronic
Toxicity
Study
Dog
LOAEL
=
10
mg/
kg/
day
based
on
methemoglobinemia
and
sulfhemoglobinemia
Cancer
(
Oral,
dermal,
inhalation)
Diflubenzuron
Not
Required
Not
Applicable
Acceptable
oral
rat
and
mouse
carcinogenicity
studies;
no
evidence
of
carcinogenic
or
mutagenic
potential.
Group
E
evidence
of
non
carcinogenicity
for
humans.
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19,
2002
/
Rules
and
Regulations
TABLE
2.
SUMMARY
OF
TOXICOLOGICAL
DOSE
AND
ENDPOINTS
FOR
DIFLUBENZURON
AND
ITS
METABOLITES
FOR
USE
IN
HUMAN
RISK
ASSESSMENT1.
Continued
Exposure
Scenario
Dose
Used
in
Risk
Assessment
UF
FQPA
SF**
and
LOC
for
Risk
Assessment
Study
and
Toxicological
Effects
Cancer
(
Oral,
dermal,
inhalation)
PCA
Group
B2
probably
human
carcinogen
Q1*
1.12
x
1
1
(
mg/
kg/
day)
1
Not
Applicable
NTP
Oral
mouse
study
Cancer
(
Oral,
dermal,
inhalation)
CPU
Q1*
based
on
monuron
a
structural
analog
and
the
Q1*
1.52
x
10
2
Not
Applicable
NTP
Oral
rat
study
1UF
=
uncertainty
factor,
FQPA
SF
=
FQPA
safety
factor,
NOAEL
=
no
observed
adverse
effect
level,
LOAEL
=
lowest
observed
adverse
effect
level,
cPAD
=
chronic
population
adjusted
dose,
RfD
=
reference
dose,
MOE
=
margin
of
exposure,
LOC
=
level
of
concern.
2Conversion
from
mg/
L
to
oral
dose
(
mg/
kg/
day)
*
The
reference
to
the
FQPA
Safety
Factor
refers
to
any
additional
safety
factor
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
180.377)
for
the
combined
residues
of
the
insecticide
diflubenzuron
(
N[[
4
chlorophenyl)
amino]
carbonyl]
2,6
difluorobenzamide
and
its
metabolites,
in
or
on
a
variety
of
raw
agricultural
commodities.
Risk
assessments
were
conducted
by
EPA
to
assess
dietary
exposures
from
diflubenzuron
and
its
metabolites
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.
Acute
doses
and
endpoints
were
not
selected
for
the
general
U.
S.
population
(
including
infants
and
children)
or
the
females
13
50
years
old
population
subgroup
for
diflubenzuron;
therefore,
an
acute
dietary
exposure
analysis
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
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:
For
the
chronic
analysis,
anticipated
residue
(
AR)
information
based
on
field
trial
data
and
percent
crop
treated
(%
CT)
information
for
some
commodities
were
used.
Dietary
exposure
estimates
for
representative
population
subgroups
are
presented
in
Table
3.
Chronic
exposure
estimates
are
expressed
in
mg/
kg
bw/
day
and
as
a
percent
of
the
cPAD.
The
chronic
dietary
risk
assessment
also
indicates
that
for
all
included
commodities,
the
chronic
dietary
risk
estimates
are
below
Agency's
level
of
concern
(<
100%
cPAD)
for
the
general
U.
S.
population
(<
1.0%
of
the
cPAD)
and
all
population
subgroups.
The
chronic
dietary
exposure
estimate
for
the
highest
exposed
population
subgroup
(
all
infants
(<
1
year
old))
is
5.5%
of
the
cPAD.
TABLE
3.
RESULTS
OF
CHRONIC
DIETARY
EXPOSURE
ANALYSIS.
Population
Subgroup
cPAD
(
mg/
kg/
day)
Exposure
(
mg/
kg/
day)
%
cPAD
U.
S.
Population
(
Total)
0.02
0.000153
<
1.0
All
Infants
(>
1
year
old)
0.02
0.001109
5.5
Children
1
6
years
old
0.02
0.000248
1.2
Children
7
12
years
old
0.02
0.000199
1.0
Females
13
50
years
old
0.02
0.000112
<
1.0
Males
13
19
years
old
0.02
0.000065
<
1.0
Males
20+
years
old
0.02
0.000124
<
1.0
Seniors
55+
years
old
0.02
0.000144
<
1.0
iii.
Cancer.
In
1995,
based
on
the
available
evidence,
which
included
carcinogenicity
studies
in
rats
and
mice,
and
battery
of
negative
mutagenicity
studies,
diflubenzuron
was
classified
as
Group
E,
evidence
of
noncarcinogenicity
for
humans.
Rat
metabolism
data
generated
at
this
time
also
indicated
that
diflubenzuron
was
metabolized
to
PCA
and
CPU
and
estimated
to
be
about
2%
of
in
vivo
conversion.
At
that
time,
EPA
also
considered
the
carcinogenicity
of
PCA,
a
known
diflubenzuron
metabolite,
that
was
tested
by
the
NTP
in
1989
for
carcinogenicity
in
rats
and
mice
as
a
hydrochloride
form.
In
rats
treated
with
PCA,
a
treatment
related
increased
incidence
of
uncommon
sarcomas
of
the
spleen
was
observed
in
males
and
included
fibrosarcomas,
hemangiosarcomas,
and
osteosarcomas,
many
of
which
metastasized
to
other
sites.
In
addition,
in
treated
females,
one
fibrosarcoma
and
one
osteosarcoma
were
also
observed.
Furthermore,
there
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Rules
and
Regulations
was
a
marginally
increased
incidence
of
pheochromocytomas
in
the
adrenal
glands
in
both
males
and
females
at
the
HDT.
In
mice
treated
with
PCA,
a
treatment
related
increased
incidence
of
combined
hepatocellular
adenomas/
carcinomas
was
observed
in
males.
The
increase
in
combined
tumors
was
primarily
due
to
a
dose
related
increase
in
hepatocellular
carcinomas.
Many
of
these
tumors
metastasized
to
the
lungs.
An
increased
incidence
of
hemangiosarcomas
in
the
spleen
and/
or
liver
of
the
male
mice
was
also
observed
at
the
HDT.
The
incidence
was
higher
than
the
historical
control
mean
for
male
mice.
There
was
no
evidence
of
a
carcinogenic
response
in
female
mice.
On
this
basis
PCA
was
classified
as
a
Group
B2,
probable
human
carcinogen.
Recently
submitted
tier
2
rat
metabolism
data
indicate
that
diflubenzuron
does
not
metabolize
to
PCA
or
CPU
nor
is
CPU
converted
to
PCA.
The
Agency
concluded
that
a
2%
in
vivo
conversion
factor
for
diflubenzuron
to
PCA
or
CPU
should
be
dropped.
It
was
recommended
that
noncarcinogenic
risk
assessment
should
include
parent,
CPU
and
PCA;
and
cancer
risk
for
CPU
and
PCA
should
be
assessed
individually.
The
Q1*
(
estimated
unit
risk)
for
PCA,
based
on
male
mouse
liver
adenoma
and/
or
carcinoma
combined
tumor
rates
was
calculated
to
be
1.12
x
10
1
(
mg/
kg/
day)
1
in
human
equivalents.
CPU
is
structurally
related
to
monuron
(
N,
N
dimethyl
CPU),
a
compound
producing
tumors
of
the
kidney
and
liver
in
male
rats.
Given
that
there
is
no
accepted
mechanism
of
carcinogenicity
for
monuron
and
that
CPU
is
major
metabolite
of
monuron
in
rats,
a
Q1*
was
calculated
for
monuron
and
applied
to
CPU.
The
most
potent
Q1*
for
monuron,
based
on
male
rat
liver
neoplastic
nodule
and/
or
carcinoma
combined
tumor
rats,
was
calculated
to
be
1.52
x
10
2
(
mg/
kg/
day)
1
in
human
equivalents.
Although
CPU
is
structurally
related
to
monuron,
there
is
no
need
to
assess
aggregate
or
cumulative
risk
scenarios
using
monuron
because
monuron
is
no
longer
a
registered
pesticide
active
ingredient.
a.
Cancer
risk
from
consumption
of
PCA
and
CPU.
Based
on
the
submitted
metabolism
studies,
there
are
two
possible
sources
for
dietary
exposure
to
PCA
and
CPU:
Residues
in
plants/
fungi
(
mushrooms)
and
residues
in
animal
commodities
(
milk
and
liver).
b.
Mushrooms/
Milk/
Liver.
EPA
used
results
from
metabolism
studies
to
determine
the
percent
of
the
total
radioactive
residue
(
TRR)
present
as
PCA+
CPU
in
mushrooms,
milk
and
liver.
For
milk
and
liver,
ARs
were
calculated
from
the
results
of
the
ruminant
feeding
study
using
tolerance
level
residues
in
livestock
feed
items
and
adjusting
for
percent
crop
treated.
The
total
levels
of
PCA+
CPU
were
estimated
by
multiplying
the
ratio
of
(
PCA+
CPU)/
Diflubenzuron
by
the
diflubenzuron
consumption
(
from
DEEM).
The
U.
S.
population
exposure
to
PCA
and
CPU
is
given
in
Table
4
as
follows.
TABLE
4.
DIETARY
CANCER
EXPOSURE
(
TO
PCA
AND
CPU).
Commodity
(
PCA+
CPU)/
Diflubenzuron
Ratio
Diflubenzuron
Consumption
mg/
kg/
day
PCA+
CPU
Consumption
mg/
kg/
day
CPU/(
PCA+
CPU)
Ratio
PCA
Consumption
mg/
kg/
day
CPU
Consumption
mg/
kg/
day
Mushrooms
3.45
0.0000018
0.0000062
0.331
0.0000042
0.00000205
Milk
1.33
0.0000003
0.0000004
1.02
0
0.0000004
Liver
0.21
0.0000008
0.00000017
0.97
5
x
10
9
0.00000016
Total
0.0000068
0.0000042
0.0000026
1Worst
case
ratio.
Overall
U.
S.
exposure
to
PCA
(
Table
4):
0.0000042
mg/
kg/
day
Carcinogenic
Risk:
4.7
x
10
7
(
0.0000042
mg/
kg/
day
x
0.112
(
mg/
kg/
day)
1)
Overall
U.
S.
exposure
to
CPU
(
Table
4):
0.0000026
mg/
kg/
day
Carcinogenic
Risk:
3.9
x
10
87
(
0.0000026
mg/
kg/
day
x
0.0152
(
mg/
kg/
day)
1)
The
Agency
does
not
consider
the
cancer
dietary
risk
from
either
PCA
or
CPU
to
exceed
the
Agency's
level
of
concern
(
generally,
in
the
range
of
10
6).
iv.
Anticipated
residue
and
percent
crop
treated
information.
Section
408(
b)(
2)(
E)
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),
EPA
will
issue
a
data
callin
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)
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
percent
crop
treated
(
PCT)
as
required
by
section
408(
b)(
2)(
F),
EPA
may
require
registrants
to
submit
data
on
PCT.
The
Agency
used
percent
crop
treated
(
PCT)
information
as
follows.
Dietary
exposure
estimates
were
based
on
the
following
percent
crop
treated
(
PCT)
estimates:
Grass,
1%;
grapefruit,
8%;
mushrooms,
31%;
oranges,
2%;
tangerines,
4%;
cottonseed
oil
and
meal,
2%;
soybean,
1%;
cattle
bolus,
5%,
walnuts
50%.
Other
commodities
were
assumed
to
be
100
percent
treated.
Anticipated
residue
levels
for
diflubenzuron
were
calculated
in
livestock,
citrus
and
mushroom
commodities.
Anticipated
residue
estimates
for
diflubenzuron
were
not
calculated
for
other
raw
agricultural
commodities.
Percent
crop
treated
data
were
utilized
where
available.
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Vol.
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Thursday,
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/
Rules
and
Regulations
The
Agency
believes
that
the
three
conditions
listed
above
regarding
percent
crop
treated
information
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
diflubenzuron
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
diflubenzuron
(
N[[
4
chlorophenyl)
amino]
carbonyl]
2,6
difluorobenzamide)
and
its
metabolites,
4
chlorophenylurea
(
CPU)
and
4
chloroaniline
(
PCA)
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
diflubenzuron
(
N[[
4
chlorophenyl)
amino]
carbonyl]
2,6
difluorobenzamide)
and
its
metabolites,
4
chlorophenylurea
(
CPU)
and
4
chloroaniline
(
PCA).
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.
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
diflubenzuron
they
are
further
discussed
in
the
aggregate
risk
sections.
Based
on
the
PRZM/
EXAMS
and
SCIGROW
models
the
estimated
environmental
concentrations
(
EECs)
of
diflubenzuron
and
CPU
are
estimated
to
be
0.99
ppb
(
diflubenzuron)
and
8.81
ppb
(
CPU)
for
surface
water
and
0.0023
ppb
(
diflubenzuron)
and
0.065
ppb
(
CPU)
for
ground
water.
PCA
is
not
a
significant
metabolite
in
the
environment.
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).
Although
there
are
no
registered
homeowner
uses
for
diflubenzuron,
there
is
potential
for
professional
applications
to
outdoor
residential
and
recreational
areas
to
control
mosquitos,
moths,
and
other
insects.
However,
due
to
the
low
dermal
absorption
rate
(
0.05%)
and
extremely
low
dermal
and
inhalation
toxicity,
exposure
through
these
uses
is
expected
to
be
insignificant,
and
residential
postapplication
exposure
was
not
quantitatively
evaluated.
4.
Cumulative
exposure
to
substances
with
a
common
mechanism
of
toxicity.
Section
408(
b)(
2)(
D)(
v)
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
diflubenzuron
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,
diflubenzuron
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
diflubenzuron
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.
FFDCA
section
408
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
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and
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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.
Based
on
the
developmental
and
reproductive
toxicity
studies
summarized
in
Table
1,
there
is
no
indication
of
quantitative
or
qualitative
increased
susceptibility
of
rats
or
rabbits
to
in
utero
or
postnatal
exposure.
3.
Conclusion.
There
is
a
complete
toxicity
data
base
for
diflubenzuron
and
exposure
data
are
complete
or
are
estimated
based
on
data
that
reasonably
accounts
for
potential
exposures.
Based
on
the
developmental
and
reproductive
data
available,
EPA
determined
that
the
10X
safety
factor
to
protect
infants
and
children
(
as
required
by
FQPA)
should
be
removed.
This
decision
was
based
on
the
following:
i.
There
is
no
indication
of
quantitative
or
qualitative
increased
susceptibility
of
rats
or
rabbits
to
in
utero
or
postnatal
exposure;
ii.
A
developmental
neurotoxicity
study
(
DNT)
with
diflubenzuron
is
not
required;
iii.
Food
and
drinking
water
exposure
assessments
will
not
underestimate
the
potential
exposure
for
infants
and
children;
and
iv.
There
are
currently
no
registered
or
proposed
residential
(
nonoccupational
uses
of
diflubenzuron
for
homeowners.
Although
there
are
no
registered
homeowner
uses,
there
is
potential
for
professional
applications
to
outdoor
residential
and
recreational
areas
to
control
mosquitos,
moths,
and
other
insects.
However,
the
potential
for
post
application
residential
exposures
are
expected
to
be
limited.
Due
to
the
low
dermal
absorption
rate
(
0.5%)
of
diflubenzuron,
and
since
it
is
only
applied
to
the
tree
canopy
to
control
gypsy
moths
and
mosquitoes,
minimal
bystander
contact
is
expected.
Recently,
EPA
has
received
objections
to
a
tolerance
it
established
for
residues
of
diflubenzuron
in
or
on
pears.
The
objections
were
filed
by
the
Natural
Resources
Defense
Council
(
NRDC)
and
raised
several
issues
regarding
aggregate
exposure
estimates
and
the
additional
safety
factor
for
the
protection
of
infants
and
children.
NRDC's
objections
raise
complex
legal,
scientific,
policy,
and
factual
matters
and
EPA
has
initiated
a
public
comment
period
on
them
in
the
Federal
Register
of
June
19,
2002
(
67
FR
41628)
(
FRL
7167
7),
which
ends
on
September
17,
2002.
Although
that
proceeding
remains
ongoing,
prior
to
acting
on
this
current
tolerance
action,
EPA
reviewed
the
diflubenzuronspecific
objections
raised
by
NRDC
and
has
addressed
them
below.
NRDC
claims
datagaps
include
missing
residue
chemistry
and
toxicology
data
for
two
diflubenzuron
metabolites,
deemed
necessary
by
EPA
to
justify
an
unconditional
registration.
EPA
determined
that
the
toxicology
database
for
diflubenzuron
is
complete
for
assessment
of
increased
susceptibility
to
infants
and
children
as
required
by
the
Food
Quality
Protection
Act
(
FQPA)
.
There
are
no
data
gaps
for
the
assessment
of
the
effects
of
diflubenzuron
following
in
utero
and/
or
postnatal
exposure.
There
was
no
evidence
that
diflubenzuron
targets
the
nervous
system;
neither
clinical
signs
indicative
of
neurotoxicity
nor
neuropathology
were
seen
in
any
of
the
acute,
subchronic
or
chronic
studies.
There
are
reliable
data
that
indicate
there
are
(
residual)
concerns
for
preand
or
post
natal
toxicity.
There
was
no
evidence
(
quantitative
or
qualitative)
of
increased
susceptibility
following
in
utero
exposure
to
rats
or
rabbits
or
to
postnatal
exposure
to
rats.
In
the
prenatal
developmental
toxicity
studies
in
rats
and
rabbits,
no
developmental
toxicity
was
seen
at
the
Limit
Dose
(
1,000
mg/
kg/
day)
and
in
the
twogeneration
reproduction
study
in
rats
toxicity
in
the
offspring
was
manifested
as
decreased
body
weight
at
approximately
4,000
mg/
kg/
day
(
4
times
the
Limit
Dose).
Based
on
the
lack
of
evidence
of
neurotoxic
potential
and
increased
susceptibility,
EPA
determined
that
a
developmental
neurotoxicity
study
in
rats
was
not
required.
The
Agency
believes
that
it
has
sufficient
data
for
the
metabolites,
PCA
and
CPU
because
the
rate
of
metabolism
of
diflubenzuron
to
PCA
or
CPU
in
plants,
ruminants,
and
the
environment
is
low
and,
thus,
exposure
to
these
metabolites
will
be
minimal.
Adequate
data
are
available
to
assess
the
cancer
risks
for
both
PCA
and
CPU.
Even
using
the
most
conservative
cancer
risk
assessment
model,
which
is
the
low
dose
linear
model,
risk
is
negligible.
EPA's
experience
is
that
a
risk
assessment
using
a
low
dose
linear
cancer
assessment
will
be
the
most
sensitive
risk
endpoint
indicating
that
additional
hazard
testing
for
these
metabolites
will
not
lead
to
a
more
protective
regulatory
decision.
NRDC
also
claims
that
by
relying
on
anticipated
residue
estimates
for
diflubenzuron
on
certain
crops
EPA
vastly
underestimates
dietary
exposure.
This
underestimation
occurs,
according
to
NRDC
because
EPA
does
not
take
into
account
that
a
significant
number
of
consumers
buy
produce
at
farm
stands.
Even
assuming
that
exposure
as
a
result
of
purchases
at
farm
stands
constitute
more
than
a
negligible
exposure,
NRDC's
claims
here
are
inaccurate.
Anticipated
residues
are
based
on
data
from
crop
field
trials
using
application
rates
and
procedures
that
will
produce
maximum
residues
under
the
currentlyapproved
pesticide
label
at
the
time
of
harvest.
As
such,
they
are
likely
to
overstate
not
understate
residue
levels
of
crops
at
farm
stands.
Finally,
NRDC
asserts
that
EPA
has
underestimated
aggregate
exposure
to
diflubenzuron
because
EPA
concluded
that
application
of
diflubenzuron
to
tree
canopies
would
result
in
negligible
residential
exposure
to
diflubenzuron.
After
review,
however,
EPA
reaffirms
that
these
potential
exposures
are
expected
to
be
limited.
The
label
states
that
``
applications
should
be
made
during
periods
of
minimal
use.''
and
requires
users
to
``
Notify
persons
using
recreational
facilities
or
living
in
the
area
to
be
sprayed
before
application.''
Diflubenzuron
is
only
applied
by
commercial
applicators
to
the
tree
canopy
for
control
of
gypsy
moths
and
mosquitoes.
Generally
applied
by
helicopter,
these
sprays
are
not
aerosols
or
ultra
low
volume
sprays
designed
as
space
sprays,
but
are
rather
directed
to
the
tree
canopy
and
designed
to
impinge
on
the
tree
tops
where
they
would
be
effective
in
pest
control.
The
sprays
designed
for
application
to
tree
canopies
utilize
much
larger
droplet
sizes
which
are
essentially
nonrespirable;
therefore,
minimal
inhalation
exposure
to
bystanders
is
expected.
Additionally,
due
to
a
low
dermal
absorption
rate
(
0.5%),
the
potential
for
dermal
exposure
to
bystanders
is
expected
to
be
minimal.
In
any
event,
EPA
would
note
that
the
results
of
the
chronic
dietary
analysis
indicated
that
the
estimated
chronic
dietary
risk
associated
with
the
proposed
use
of
diflubenzuron
was
well
below
the
Agency's
level
of
concern
for
the
general
U.
S.
population.
In
fact,
the
highest
exposed
population
subgroup
(
all
infants
<
1
years
of
age)
is
5.5%
of
the
PAD.
The
PAD
is
the
Population
Adjusted
Dose,
which
is
the
Reference
Dose
(
RfD)
divided
by
the
FQPA
Safety
Factor.
The
Agency's
level
of
concern
is
for
exposures
in
excess
of
100%
of
the
PAD.
An
acute
dietary
exposure
risk
assessment
was
not
conducted
since
no
hazard
was
identified
for
any
population,
including
infants
and
children,
following
a
single
exposure
to
diflubenzuron
(
i.
e.,
no
hazard
was
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and
Regulations
identified,
therefore,
quantification
of
risk
is
not
required).
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
Office
of
Water
are
used
to
calculate
DWLOCs:
2L/
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
is
no
risk
from
acute
dietary
exposure
(
1
day)
to
diflubenzuron
as
there
is
no
toxic
endpoint
identified.
2.
Chronic
risk.
Using
the
exposure
assumptions
described
in
this
unit
for
chronic
exposure,
EPA
has
concluded
that
exposure
to
diflubenzuron
and
its
metabolite
CPU
from
food
will
utilize
1%
of
the
cPAD
for
the
U.
S.
population,
5.5%
of
the
cPAD
for
infants
and
1.2%
of
the
cPAD
for
children
1
6
years
old.
Based
on
the
use
pattern,
chronic
residential
exposure
to
residues
of
diflubenzuron
is
not
expected.
In
addition,
there
is
potential
for
chronic
dietary
exposure
to
diflubenzuron
and
its
metabolite
CPU
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
5
below.
For
the
chronic
analysis,
ARs
and
%
CT
information
for
some
commodities
were
used
(
Tier
3).
The
results
of
the
chronic
analysis
for
diflubenzuron
indicate
that
the
estimated
chronic
dietary
risk
associated
with
the
proposed
use
of
diflubenzuron
is
below
HED's
level
of
concern.
The
EECs
generated
by
EFED
are
less
than
HED's
DWLOCs.
Thus,
chronic
non
cancer
aggregate
risk
estimates
are
below
HED's
level
of
concern.
Table
5
summarizes
the
chronic
non
cancer
aggregate
exposure
to
diflubenzuron
residues.
TABLE
5.
AGGREGATE
RISK
ASSESSMENT
FOR
CHRONIC
(
NON
CANCER)
EXPOSURE
TO
DIFLUBENZURON
AND
CPU
Scenario/
Population
Subgroup
cPAD,
mg/
kg/
day
%
cPAD
(
Food)
Ground
Water
EEC,
ppb
Surface
Water
EEC1,
ppb
Chronic
DWLOC2,
ppb
U.
S.
population
0.02
<
1.0
0.067
9.8
700
All
infants
(<
1
year
old)
0.02
5.5
0.067
9.8
190
Children
(
1
6
years
old)
0.02
1.2
0.067
9.8
200
Children
(
7
1
2
years
old)
0.02
1.0
0.067
9.8
200
Females
(
13
50
years
old)
0.02
<
1.0
0.067
9.8
700
Males
(
13
19
years
old)
0.02
<
1.0
0.067
9.8
700
Males
(
20+
years
old)
0.02
<
1.0
0.067
9.8
700
Seniors
(
55+
years
old)
0.02
<
1.0
0.067
9.8
700
1
EECs
for
diflubenzuron
+
CPU
resulting
from
the
worst
case
water
exposure
estimate
scenario
(
peppers).
2
The
chronic
DWLOCs
were
calculated
as
follows:
DWLOC
(
µ
g/
L)
=
maximumwater
exposure
(
mg/
kg/
day)/
consumption
(
L/
day)
x
0.001
mg/
µ
g
x
body
weight(
kg)
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).
Diflubenzuron
is
not
registered
for
use
on
any
sites
that
would
result
in
substantial
residential
exposure.
Therefore,
a
short
term
aggregate
risk
assessment
was
not
performed.
4.
Intermediate
term
risk.
Intermediate
term
aggregate
exposure
takes
into
account
residential
exposure
plus
chronic
exposure
to
food
and
water
(
considered
to
be
a
background
exposure
level).
Based
on
the
use
pattern,
intermediate
term
exposure
to
diflubenzuron
would
not
be
expected.
Therefore,
an
intermediate
term
aggregate
risk
assessment
was
not
performed.
5.
Aggregate
cancer
risk
for
U.
S.
population.
As
discussed
in
the
Exposure
Assessment
in
Unit.
III.
C.
of
this
document,
CPU
is
the
only
metabolite
of
concern
for
aggregate
cancer
risk
that
is
likely
to
be
found
in
drinking
water.
For
the
chronic
analysis,
ARs
and
%
CT
information
for
some
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and
Regulations
commodities
were
used
(
Tier
3).
The
results
of
the
cancer
analysis
indicate
that
the
estimated
cancer
dietary
risk
from
CPU
associated
with
the
proposed
use
of
diflubenzuron
is
below
the
Agency's
level
of
concern.
Based
on
a
negligible
risk
in
the
range
of
1
3
x
10
6,
the
DWLOCs
were
calculated
to
be
in
the
range
of
2.2
6.8
µ
g/
L.
The
EECs
for
surface
water
(
8.81
µ
g/
L)
slightly
exceed
the
DWLOCs.
Since
PCA
is
not
found
in
drinking
water,
the
aggregate
cancer
risk
for
PCA
is
the
risk
calculated
for
food
only
(
4.7
x
10
7).
The
Agency
used
a
screening
level
model
designed
to
estimate
pesticide
concentrations
in
surface
water.
Although
the
cancer
DWLOC
is
exceeded
by
the
EEC
for
CPU
on
peppers,
a
number
of
factors
lead
the
Agency
to
believe
that
the
actual
lifetime
exposure
through
drinking
water
from
the
metabolite
CPU
will
be
less
than
the
cancer
DWLOC.
An
explanation
is
provided
below:
i.
The
dietary
risk
for
CPU
is
minimal
from
mushrooms,
milk,
and
liver.
Therefore,
the
dietary
risk
from
CPU
occurs
mostly
from
exposure
that
results
from
its
formation
in
the
environment
and
leaching
into
the
surface
water
as
a
result
of
field
application.
ii.
The
PRZM/
EXAMS
model
does
not
consider
the
impact
of
processing
(
mixing,
dilution,
or
treatment)
of
raw
water
for
distribution
of
drinking
water
and
removal
of
pesticides
from
source
water.
iii.
In
the
absence
of
reliable
monitoring
data,
a
default
percent
crop
area
(
PCA)
factor
is
applied
to
the
PRZM/
EXAMS
modeling.
Although
the
DWLOC
is
exceeded
for
peppers,
the
PCA
factor
of
87%
that
was
used
in
the
assessment
is
likely
to
be
higher
than
the
actual
factor
that
would
be
appropriate
for
peppers
in
an
agricultural
watershed.
iv.
To
address
the
uncertainties
caused
by
the
absence
of
reliable
monitoring
data,
the
applicant
has
agreed
to
conduct
edge
of
field
runoff
studies
for
peppers
to
monitor
the
actual
concentrations
of
CPU
in
surface
water.
These
data,
albeit
still
relevant
solely
for
estimation
of
residues
in
raw
water
and
thus
still
likely
to
overestimate
residues
in
actual
drinking
water,
are
likely
to
lower
the
upper
bound
risk
estimate
considerably.
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
diflubenzuron
residues.
IV.
Other
Considerations
A.
Analytical
Enforcement
Methodology
Adequate
methods
are
available
for
the
analysis
of
diflubenzuron,
PCA,
and
CPU
in
crops.
Three
enforcement
methods
for
diflubenzuron
are
published
in
the
Pesticide
Analytical
Method
Volume
II
(
PAM
II)
as
Methods
I,
II,
and
III.
Method
II
is
a
GC/
ECD
method
that
can
separately
determine
residues
of
diflubenzuron,
CPU,
and
PCA
in
eggs,
milk,
and
livestock
tissues.
All
three
methods
have
undergone
a
successful
petition
method
validation
(
PMV)
and
are
acceptable
for
enforcement
purposes.
Individual
analyte
methods
for
CPU
(
limit
of
quantitation
(
LOQ)
of
0.001
ppm)
and
PCA
(
LOQ
of
0.005
ppm)
have
been
successfully
validated
by
the
Analytical
Chemistry
Branch
(
ACB).
Multiresidue
Method
(
MRM).
The
FDA
PESTDATA
database
dated
1/
94
(
PAM
Vol.
I,
Appendix
II)
contains
no
information
on
diflubenzuron
recovery
using
MRM
PAM,
Vol.
I
Sections
302,
303,
and
304.
However,
the
registrant
has
submitted
Multiresidue
testing
data
that
the
Agency
has
forwarded
to
the
FDA.
Also,
the
results
of
MRM
testing
of
PCA
and
CPU
have
been
submitted
and
forwarded
to
FDA.
Neither
PCA
nor
CPU
were
adequately
recovered
by
any
protocols.
B.
International
Residue
Limits
There
are
no
Codex
proposals,
Canadian,
or
Mexican
limits
for
residues
of
diflubenzuron
on
rice.
A
compatibility
issue
is
not
relevant
to
the
proposed
tolerances.
C.
Conditions
Environmental
fate.
Edge
of
field
monitoring
study
for
peppers.
V.
Conclusion
Therefore,
the
tolerance
is
established
for
combined
residues
of
the
insecticide
diflubenzuron
(
N[[
4
chlorophenyl)
amino]
carbonyl]
2,6
difluorobenzamide)
and
its
metabolites,
4
chlorophenylurea
(
CPU)
and
4
chloroaniline
(
PCA),
in
or
on
the
following
raw
agricultural
commodities:
Grass,
forage,
fodder,
and
hay
group
at
6.0
ppm;
pepper
at
1.0
ppm;
stone
fruit
group
(
except
cherries)
at
0.07
ppm;
tree
nut
group
at
0.06
ppm;
almond
hulls
at
6.0
ppm;
pistachio
at
0.06
ppm;
cattle,
meat
byproducts
at
0.15
ppm;
goat,
meat
byproducts
at
0.15
ppm;
hog,
meat
byproducts
at
0.15
ppm;
horse,
meat
byproducts
at
0.15
ppm;
sheep,
meat
byproducts
at
0.15
ppm.
The
tolerances
for
pasture
grass
and
walnut
will
be
deleted,
concomitant
with
the
establishment
of
the
tree
nut
group
and
grass,
forage,
fodder,
and
hay
group
tolerances.
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
of
1996,
EPA
will
continue
to
use
those
procedures,
with
appropriate
adjustments,
until
the
necessary
modifications
can
be
made.
The
new
section
408(
g)
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),
as
was
provided
in
the
old
FFDCA
sections
408
and
409.
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
control
number
OPP
2002
0224
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
November
18,
2002.
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
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/
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September
19,
2002
/
Rules
and
Regulations
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460.
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.
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.
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.
2.
Mail
your
copies,
identified
by
docket
control
number
OPP
2002
0224,
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.
In
person
or
by
courier,
bring
a
copy
to
the
location
of
the
PIRIB
described
in
Unit
I.
B.
2.
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
FFDCA
section
408(
d)
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
FFDCA
section
408(
d),
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
FFDCA
section
408(
n)(
4).
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
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Federal
Register
/
Vol.
67,
No.
182
/
Thursday,
September
19,
2002
/
Rules
and
Regulations
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:
September
11,
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
374.
2.
Section
180.377
is
amended
as
follows:
i.
By
removing
the
entries
for
``
Cattle,
meat
byproducts'';
``
Goat,
meat
byproducts'';
``
Hog,
meat
byproducts'';
``
Horse,
meat
byproducts'';
``
Sheep,
meat
byproducts'';
and
``
Walnut''
from
the
table
in
paragraph
(
a)(
1);
ii.
By
alphabetically
adding
the
entries
for
``
Almond,
hulls'';
``
Cattle,
meat
byproducts'';
``
Fruit,
stone,
group
12,
except
cherries'';
``
Goat,
meat
byproducts'';
``
Grass,
fodder,
forage,
and
hay,
group
17'';
``
Hog,
meat
byproducts'';
``
Horse,
meat
byproducts'';
``
Nut,
tree,
group
14'';
``
Pepper'';
``
Pistachio'';
and
``
Sheep,
meat
byproducts''
to
the
table
in
paragraph
(
a)(
2);
and
iii.
By
removing
the
text
from
paragraph
(
c)
and
reserving
paragraph
(
c)
with
the
heading.
The
additions
and
revisions
read
as
follows:
§
180.377
Diflubenzuron;
tolerances
for
residues.
(
a)
General.
(
1)
*
*
*
(
2)
*
*
*
Commodity
Parts
per
million
Almond
,
hulls
6.0
Cattle,
meat
byproducts
0.15
Fruit,
stone,
group
12,
except
cherries
0.07
Goat,
meat
byproducts
0.15
Grass,
forage,
fodder,
and
hay,
group
17
6.0
Hog,
meat
byproducts
0.15
Horse,
meat
byproducts
0.15
Nut,
tree,
group
14
0.06
*
*
*
*
*
Pepper
1.0
Pistachio
0.06
*
*
*
*
*
Sheep,
meat
byproducts
0.15
*
*
*
*
*
[
FR
Doc.
02
23818
Filed
9
18
02;
8:
45
am]
BILLING
CODE
6560
50
S
ENVIRONMENTAL
PROTECTION
AGENCY
40
CFR
Part
300
[
FRL
7377
4]
National
Oil
and
Hazardous
Substance
Pollution
Contingency
Plan;
National
Priorities
List
AGENCY:
Environmental
Protection
Agency.
ACTION:
Direct
final
notice
of
deletion
of
the
Basic
Microelectronics,
Incorporated
(
BMI)
Textron
Superfund
Site
from
the
National
Priorities
List.
SUMMARY:
The
Environmental
Protection
Agency
(
EPA)
Region
4
is
publishing
a
direct
final
notice
of
deletion
of
the
BMI
Textron
Superfund
Site
(
Site),
located
in
Lake
Park,
West
Palm
Beach
County,
Florida,
from
the
National
Priorities
List
(
NPL).
The
NPL,
promulgated
pursuant
to
section
105
of
the
Comprehensive
Environmental
Response,
Compensation,
and
Liability
Act
(
CERCLA)
of
1980,
as
amended,
is
appendix
B
of
40
CFR
part
300,
which
is
the
National
Oil
and
Hazardous
Substances
Pollution
Contingency
Plan
(
NCP).
This
direct
final
deletion
is
being
published
by
EPA
with
the
concurrence
of
the
State
of
Florida,
through
the
Florida
Department
of
Environmental
Protection
(
FDEP
(
formerly
FDER))
because
EPA
has
determined
all
appropriate
response
actions
under
CERCLA
have
been
completed
and,
therefore,
further
remedial
action
pursuant
to
CERCLA
is
not
appropriate.
DATES:
This
direct
final
deletion
will
be
effective
November
18,
2002,
unless
EPA
receives
adverse
comments
by
October
21,
2002.
If
adverse
comments
are
received,
EPA
will
publish
a
timely
withdrawal
of
the
direct
final
deletion
in
the
Federal
Register
informing
the
public
the
deletion
will
not
take
effect.
ADDRESSES:
Comments
may
be
mailed
to:
Jan
Martin,
Remedial
Project
Manager
(
RPM),
U.
S.
EPA,
Region
4
(
4WD
SSMB),
61
Forsyth
Street,
SW.,
Atlanta,
Georgia
30303,
(
404)
562
8593,
martin.
jan@
epa.
gov.
Information
Repositories:
Comprehensive
information
about
the
Site
is
available
for
viewing
and
copying
at
the
Site
information
repositories
located
at:
U.
S.
EPA
Record
Center,
61
Forsyth
Street,
SW.,
Atlanta,
Georgia
30365,
Phone:
(
404)
562
8190,
Hours:
8
a.
m.
to
5
p.
m.,
Monday
through
Friday
(
By
Appointment
Only).
Lake
Park
Library,
529
Park
Avenue,
Lake
Park,
Florida
30403,
Phone:
(
561)
881
3330,
Hours:
9
a.
m.
to
8:
30
p.
m.,
Monday
and
Tuesday,
9
a.
m.
to
5:
30
p.
m.,
Wednesday
through
Friday,
9:
30
a.
m.
to
2
p.
m.,
Saturday.
FOR
FURTHER
INFORMATION
CONTACT:
Jan
Martin,
Remedial
Project
Manager
(
RPM),
U.
S.
EPA,
Region
4
(
4WD
SSMB),
61
Forsyth
Street,
SW.,
Atlanta,
Georgia
30303,
(
404)
562
8593,
martin.
jan@
epa.
gov.
SUPPLEMENTARY
INFORMATION:
Table
of
Contents
I.
Introduction
II.
NPL
Deletion
Criteria
III.
Deletion
Procedures
IV.
Basis
for
Site
Deletion
V.
Deletion
Action
I.
Introduction
EPA
Region
4
is
publishing
this
direct
final
notice
of
deletion
of
the
BMITextron
Superfund
Site
(
Site)
from
the
NPL.
The
EPA
identifies
sites
that
appear
to
present
a
significant
risk
to
public
health
or
the
environment
and
maintains
the
NPL
as
the
list
of
those
sites.
As
described
in
the
§
300.425(
e)(
3)
of
the
NCP,
sites
deleted
from
the
NPL
remain
eligible
for
remedial
actions
if
conditions
at
a
deleted
site
warrant
such
action.
Because
EPA
considers
this
action
to
be
noncontroversial
and
routine,
EPA
is
taking
it
without
prior
publication
of
a
notice
of
intent
to
delete.
This
action
will
be
effective
November
18,
2002,
unless
EPA
receives
adverse
comments
by
October
21,
2002,
on
this
document.
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| epa | 2024-06-07T20:31:43.310128 | regulations | {
"license": "Public Domain",
"url": "https://downloads.regulations.gov/EPA-HQ-OPP-2002-0224-0001/content.txt"
} |
EPA-HQ-OPP-2002-0224-0002 | Rule | "2002-11-06T05:00:00" | Diflubenzuron; Pesticide Tolerances Correction | 67566
Federal
Register
/
Vol.
67,
No.
215
/
Wednesday,
November
6,
2002
/
Rules
and
Regulations
EPA
APPROVED
IOWA
SOURCE
SPECIFIC
ORDERS/
PERMITS
Continued
Name
of
source
Order/
permit
No.
State
effective
date
EPA
approval
date
Comments
Holnam,
Inc
.......................
Permits
for
17
01
009,
Project
Nos.
99
511
and
00
468.
7/
24/
2001
November
6,
2002,
and
FR
page
citation
For
a
list
of
the
47
permits
issued
for
individual
emission
points
see
IDNR
letters
to
Holnam,
Inc.,
dated
7/
24/
01.
Lehigh
Portland
Cement
Company.
A.
C.
O.
1999
AQ
32
.........
9/
2/
1999
November
6,
2002,
and
FR
page
citation
For
a
list
of
the
41
permits
issued
for
individual
emission
points
see
IDNR
letters
to
Lehigh
dated
7/
24/
01
and
2/
18/
02.
Lehigh
Portland
Cement
Company.
Permits
for
plant
No.
17
01
005,
Project
Nos.
99
631
and
02
037.
2/
18/
2002
November
6,
2002,
and
FR
page
citation
For
a
list
of
the
41
permits
issued
for
individual
emission
points
see
IDNR
letters
to
Lehigh
dated
7/
24/
01
and
2/
18/
02.
*
*
*
*
*
[
FR
Doc.
02
27838
Filed
11
5
02;
8:
45
am]
BILLING
CODE
6560
50
P
ENVIRONMENTAL
PROTECTION
AGENCY
40
CFR
Part
180
[
OPP
2002
0224;
FRL
7277
9]
Diflubenzuron;
Pesticide
Tolerances
Correction
AGENCY:
Environmental
Protection
Agency
(
EPA).
ACTION:
Final
rule;
correction.
SUMMARY:
EPA
issued
a
final
rule
in
the
Federal
Register
of
September
19,
2002,
establishing
tolerances
for
the
insecticide
diflubenzuron
(
N[[
4
chlorophenyl)
amino]
carbonyl]
2,6
difluorobenzamide)
and
its
metabolites,
4
chlorophenylurea
(
CPU)
and
4
chloroaniline
(
PCA)
in
or
on
various
commodities.
This
document
is
being
issued
to
correct
inadvertent
omissions
in
that
document.
DATES:
This
document
is
effective
on
November
6,
2002.
FOR
FURTHER
INFORMATION
CONTACT:
Rita
Kumar,
Registration
Division
(
7505C),
Office
of
Pesticide
Programs,
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460
0001;
telephone
number:
(
703)
308
8291;
e
mail
address:
kumar.
rita@
epa.
gov.
SUPPLEMENTARY
INFORMATION:
I.
General
Information
A.
Does
This
Action
Apply
to
Me?
The
Agency
included
in
the
final
rule
a
list
of
those
who
may
be
potentially
affected
by
the
action.
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
ID
number
OPP
2002
0224.
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.
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.
What
Does
this
Correction
Do?
In
the
Federal
Register
of
September
19,
2002
(
67
FR
59006)
(
FRL
7200
4),
EPA
issued
tolerances
for
the
insecticide
diflubenzuron
(
N[[
4
chlorophenyl)
amino]
carbonyl]
2,6
difluorobenzamide)
and
its
metabolites,
4
chlorophenylurea
(
CPU)
and
4
chloroaniline
(
PCA)
in
or
on
various
commodities.
This
document
is
being
issued
to
correct
two
inadvertent
omissions
in
that
document.
FR
Doc.
02
23818
is
corrected
as
follows:
1.
On
page
59013,
in
the
middle
column,
second
full
paragraph
from
the
top,
the
fourth
sentence
should
read:
``
There
are
reliable
data
that
indicate
there
are
no
residual
concerns
for
pre
and/
or
post
natal
toxicity.''
2.
On
page
59015,
under
Unit
IV.,
section
B.
International
Residue
Limits
should
read:
``
Codex
and
Mexican
maximum
residue
limits
(
MRLs)
are
established
for
residues
of
diflubenzuron
per
se
in/
on
plums
(
including
prunes)
at
1
ppm.
Mexican
MRLs
are
established
for
residues
of
diflubenzuron
per
se.
Use
of
diflubenzuron
in
Canada
is
limited
to
mosquito
control;
therefore,
no
Canadian
MRLs
have
been
established.
Based
on
the
current
tolerance
expression,
the
Codex
and
U.
S.
tolerance
definitions
are
not
compatible.''
III.
Why
Is
This
Correction
Issued
as
a
Final
Rule?
Section
553
of
the
Administrative
Procedure
Act
(
APA),
5
U.
S.
C.
553(
b)(
B),
provides
that,
when
an
Agency
for
good
cause
finds
that
notice
and
public
procedure
are
impracticable,
unnecessary
or
contrary
to
the
public
interest,
the
agency
may
issue
a
final
rule
without
providing
notice
and
an
opportunity
for
public
comment.
EPA
has
determined
that
there
is
good
cause
for
making
today's
correction
final
without
prior
proposal
and
opportunity
for
comment,
because
EPA
is
merely
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15:
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67567
Federal
Register
/
Vol.
67,
No.
215
/
Wednesday,
November
6,
2002
/
Rules
and
Regulations
inserting
language
that
was
inadvertently
omitted
from
the
previously
published
final
rule.
EPA
finds
that
this
constitutes
good
cause
under
5
U.
S.
C.
553(
b)(
B).
IV.
Do
Any
of
the
Regulatory
Assessment
Requirements
Apply
to
This
Action?
This
document
makes
minor
corrections
to
the
preamble
of
the
final
rule
issued
on
September
19,
2002,
and
it
does
not
otherwise
impose
or
amend
any
requirements.
As
such,
the
Office
of
Management
and
Budget
(
OMB)
has
determined
that
a
technical
correction
is
not
a
``
significant
regulatory
action''
subject
to
review
by
OMB
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,
entitled
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
this
action
does
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
action
does
not
alter
the
relationships
or
distribution
of
power
and
responsibilities
established
by
Congress
in
the
preemption
provisions
of
FFDCA
section
408(
n)(
4).
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.
V.
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:
October
21,
20002.
Debra
Edwards,
Acting
Director,
Registration
Division,
Office
of
Pesticide
Programs.
[
FR
Doc.
02
27840
Filed
11
5
02;
8:
45
am]
BILLING
CODE
6560
50
S
FEDERAL
COMMUNICATIONS
COMMISSION
47
CFR
Part
1
[
WC
Docket
No.
02
269;
FCC
02
291]
Federal
State
Joint
Conference
on
Accounting
Issues
AGENCY:
Federal
Communications
Commission.
ACTION:
Final
rule.
SUMMARY:
In
this
document
the
Commission
appoints
State
representatives
to
the
Federal
State
Joint
Conference
on
Accounting
Issues
(
Joint
Conference).
Chairman
Michael
K.
Powell
also
designates
the
Honorable
Kevin
J.
Martin
as
the
Chairman
of
the
Joint
Conference.
The
Honorable
Michael
J.
Copps
will
serve
as
a
participating
federal
member.
The
intended
effect
of
this
document
is
to
provide
a
forum
for
an
ongoing
dialogue
between
the
Commission
and
the
states
in
order
to
ensure
that
regulatory
accounting
data
and
related
information
filed
by
carriers
are
adequate,
truthful,
and
thorough.
See
47
U.
S.
C.
410(
b).
FOR
FURTHER
INFORMATION
CONTACT:
Joi
Roberson
Nolen,
Wireline
Competition
Bureau,
202
418
1537.
SUPPLEMENTARY
INFORMATION:
Pursuant
to
section
410(
b)
of
the
Communications
Act
of
1934,
as
amended,
47
U.
S.
C.
410(
b),
the
Commission
appoints
the
following
State
representatives
to
the
Joint
Conference:
the
Honorable
Nancy
Brockway,
Commissioner,
New
Hampshire
Public
Utilities
Commission;
the
Honorable
Terry
Deason,
Commissioner,
Florida
Public
Service
Commission;
the
Honorable
Rebecca
A.
Klein,
Chairman,
Texas
Public
Utility
Commission;
the
Honorable
Loretta
Lynch,
President,
California
Public
Utilities
Commission;
and
the
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| epa | 2024-06-07T20:31:43.325976 | regulations | {
"license": "Public Domain",
"url": "https://downloads.regulations.gov/EPA-HQ-OPP-2002-0224-0002/content.txt"
} |
EPA-HQ-OPP-2002-0233-0001 | Rule | "2002-09-27T04:00:00" | Pseudozyma Flocculosa Strain PF-A22 UL; Exemption From the Requirement of a Tolerance. | 60960
Federal
Register
/
Vol.
67,
No.
188
/
Friday,
September
27,
2002
/
Rules
and
Regulations
Commodity
Parts
per
million
Barley,
grain
.............................
0.05
Barley,
hay
................................
0.05
Barley,
straw
.............................
0.05
Wheat,
forage
...........................
0.05
Wheat,
grain
.............................
0.05
Wheat,
hay
...............................
0.05
Wheat,
straw
.............................
0.05
(b)
Section
18
emergency
exemptions.
[Reserved]
(c)
Tolerances
with
regional
registrations.
[Reserved]
(d)
Indirect
or
inadvertent
residues.
[Reserved]
[FR
Doc.
02–
24650
Filed
9–
26–
02;
8:
45
am]
BILLING
CODE
6560–
50–
S
ENVIRONMENTAL
PROTECTION
AGENCY
40
CFR
Part
180
[OPP–
2002–
0233;
FRL–
7198–
8]
Pseudozyma
flocculosa
strain
PF
A22
UL;
Exemption
from
the
Requirement
of
a
Tolerance
AGENCY:
Environmental
Protection
Agency
(EPA).
ACTION:
Final
rule.
SUMMARY:
This
regulation
establishes
an
exemption
from
the
requirement
of
a
tolerance
for
residues
of
the
Pseudozyma
flocculosa
strain
PF
A22
UL
in
or
on
all
food
commodities.
Plant
Products
Co.
Ltd.,
submitted
a
petition
to
EPA
under
the
Federal
Food,
Drug,
and
Cosmetic
Act,
as
amended
by
the
Food
Quality
Protection
Act
of
1996,
requesting
an
exemption
from
the
requirement
of
a
tolerance.
This
regulation
eliminates
the
need
to
establish
a
maximum
permissible
level
for
residues
of
Pseudozyma
flocculosa
strain
PF
A22
UL.
DATES:
This
regulation
is
effective
September
27,
2002.
Objections
and
requests
for
hearings,
identified
by
docket
ID
number
OPP–
2002–
0233,
must
be
received
on
or
before
November
26,
2002.
ADDRESSES:
Written
objections
and
hearing
requests
may
be
submitted
by
mail,
electronically,
or
in
person.
Please
follow
the
detailed
instructions
for
each
method
as
provided
in
Unit
IX.
of
the
SUPPLEMENTARY
INFORMATION.
To
ensure
proper
receipt
by
EPA,
your
objections
and
hearing
requests
must
identify
docket
ID
number
OPP–
2002–
0233
in
the
subject
line
on
the
first
page
of
your
response.
FOR
FURTHER
INFORMATION
CONTACT:
By
mail:
Sharlene
R.
Matten,
c/
o
Product
Manager
(PM)
90,
Biopesticides
and
Pollution
Prevention
Division
(7511C),
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460;
telephone
number:
(703)
605–
0514;
e
mail
address:
matten.
sharlene@
epa.
gov.
SUPPLEMENTARY
INFORMATION:
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:
Categories
NAICS
codes
Examples
of
potentially
affected
entities
Industry
111
Crop
production
112
Animal
production
311
Food
manufacturing
32532
Pesticide
manufacturing
This
listing
is
not
intended
to
be
exhaustive,
but
rather
provides
a
guide
for
readers
regarding
entities
likely
to
be
affected
by
this
action.
Other
types
of
entities
not
listed
in
the
table
could
also
be
affected.
The
North
American
Industrial
Classification
System
(NAICS)
codes
have
been
provided
to
assist
you
and
others
in
determining
whether
or
not
this
action
might
apply
to
certain
entities.
If
you
have
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
Additional
Information,
Including
Copies
of
this
Document
and
Other
Related
Documents?
1.
Electronically.
You
may
obtain
electronic
copies
of
this
document,
and
certain
other
related
documents
that
might
be
available
electronically,
from
the
EPA
Internet
Home
Page
at
http://
www.
epa.
gov/.
To
access
this
document,
on
the
Home
Page
select
``
Laws
and
Regulations,
''
``
Regulations
and
Proposed
Rules,
''
and
then
look
up
the
entry
for
this
document
under
the
``
Federal
Register—
Environmental
Documents.
''
You
can
also
go
directly
to
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.
2.
In
person.
The
Agency
has
established
an
official
record
for
this
action
under
docket
ID
number
OPP–
2002–
0233.
The
official
record
consists
of
the
documents
specifically
referenced
in
this
action,
and
other
information
related
to
this
action,
including
any
information
claimed
as
Confidential
Business
Information
(CBI).
This
official
record
includes
the
documents
that
are
physically
located
in
the
docket,
as
well
as
the
documents
that
are
referenced
in
those
documents.
The
public
version
of
the
official
record
does
not
include
any
information
claimed
as
CBI.
The
public
version
of
the
official
record,
which
includes
printed,
paper
versions
of
any
electronic
comments
submitted
during
an
applicable
comment
period
is
available
for
inspection
in
the
Public
Information
and
Records
Integrity
Branch
(PIRIB),
Rm.
119,
Crystal
Mall
#2,
1921
Jefferson
Davis
Hwy.,
Arlington,
VA,
from
8:
30
a.
m.
to
4
p.
m.,
Monday
through
Friday,
excluding
legal
holidays.
The
PIRIB
telephone
number
is
(703)
305–
5805.
II.
Background
and
Statutory
Findings
In
the
Federal
Register
of
August
30,
2000
(65
FR
52749)
(FRL–
6739–
8),
EPA
issued
a
notice
pursuant
to
section
408
of
the
Federal
Food,
Drug,
and
Cosmetic
Act
(FFDCA),
21
U.
S.
C.
346a(
d),
as
amended
by
the
Food
Quality
Protection
Act
(FQPA)
(Public
Law
104–
170),
announcing
the
filing
of
a
pesticide
tolerance
petition
(PP
0F6136)
by
Plant
Products
Co.
Ltd.,
f314
Orenda
Rd.,
Brampton,
Ontario,
Canada
L6T
1G1.
This
notice
included
a
summary
of
the
petition
prepared
by
the
petitioner
Plant
Products
Co.
Ltd.
There
were
no
comments
received
in
response
to
the
notice
of
filing.
The
petition
requested
that
40
CFR
part
180
be
amended
by
establishing
an
exemption
from
the
requirement
of
a
tolerance
for
residues
of
Pseudozyma
flocculosa
strain
PF
A22
UL
in
or
on
all
food
commodities.
III.
Risk
Assessment
New
section
408(
c)(
2)(
A)(
i)
of
the
FFDCA
allows
EPA
to
establish
an
exemption
from
the
requirement
for
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(
c)(
2)(
A)(
ii)
defines
``
safe''
to
mean
that
``
there
is
a
reasonable
certainty
that
no
harm
will
result
from
aggregate
exposure
to
the
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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)
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.
.
.
.''
Additionally,
section
408(
b)(
2)(
D)
requires
that
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
performs
a
number
of
analyses
to
determine
the
risks
from
aggregate
exposure
to
pesticide
residues.
First,
EPA
determines
the
toxicity
of
pesticides.
Second,
EPA
examines
exposure
to
the
pesticide
through
food,
drinking
water,
and
through
other
exposures
that
occur
as
a
result
of
pesticide
use
in
residential
settings.
IV.
Toxicological
Profile
Consistent
with
section
408(
b)(
2)(
D)
of
FFDCA,
EPA
has
reviewed
the
available
scientific
data
and
other
relevant
information
in
support
of
this
action
and
considered
its
validity,
completeness,
and
reliability
and
the
relationship
of
this
information
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.
Pseudozyma
flocculosa
was
isolated
in
1986
from
the
leaves
of
red
clover,
Trifolium
pratense,
infected
with
powdery
mildew,
Erysiphe
polygoni,
by
researchers
at
Agriculture
and
AgriFood
Canada,
Harrow,
Ontario.
Initially,
this
organism
was
erroneously
identified
as
a
new
ascomycetous
yeast
with
an
anamorphic
state
in
the
broad
genus
Sporothrix
and
a
teleomorphic
state
in
the
genus
Stephanoascus.
In
1995,
its
taxon
was
changed
to
P.
flocculosa
following
ribosomal
DNA
analysis.
The
genus
Pseudozyma
contains
other
smut
like
anamorphs,
including
P.
rugulosa
(formerly
Sporothrix
rugulosa).
P.
flocculosa
is
a
phyllosphere
epiphyte
and
hyperparasite
of
primarily
powdery
mildew
but
has
been
isolated
in
association
with
other
leaf
surface
molds.
It
is
widely
distributed
in
North
America
(Canada
and
USA)
and
in
Europe
on
aerial
plant
surfaces
in
field
or
greenhouse
agricultural
ecosystems.
P.
flocculosa
antagonizes
a
number
of
different
powdery
mildew
fungi
(Sphaerotheca
pannosa
var.
rosae,
Sphaerotheca
fulginea,
Erysiphe
graminis
var.
tritici
and
Erysiphe
polygoni)
on
many
different
plants
in
greenhouse
and
field
environments
when
the
relative
humidity
is
greater
or
equal
to
70%.
This
fungus
is
a
necrotroph
mycoparasite
that
kills
susceptible
target
host
cells
upon
contact
or
in
close
proximity.
Rapid
death
and
collapse
of
host
cells
without
penetration
is
brought
about
by
the
secretion
of
three
fungitoxic
unsaturated
C
17
fatty
acids
(9
heptadecenoic
acid,
6
methyl
9
heptadecenoic
acid
and
4
methyl
7,11
heptadecadienoic
acid)
and
an
acyclic
norterpene
(2,
6,
10,
14,
18
pentamethyl
2,
6,
8,
10,
12,
14,
17
nonadecaheptene
1,19
diol).
The
fungitoxins
disrupt
susceptible
plasma
membranes
and
cytoplasmic
organelles
within
30
minutes
of
exposure.
The
inhibitory
response
includes
a
loss
of
proteins
and
electrolytes.
After
24
hours,
the
host
cells
rapidly
collapse
and
die
as
a
result
of
the
activity
of
the
fungitoxins
on
the
host
cell's
membranes
and
lipids.
Sensitivity
to
the
unsaturated
C
17
free
fatty
acids
is
related
to
a
high
degree
of
unsaturation
of
phospholipid
fatty
acids
and
a
low
proportion
of
sterols.
P.
flocculosa
strain
PF
A22
UL
was
considered
of
low
toxicity
and
no
pathogenicity
based
on
the
results
of
the
Tier
I
toxicology
studies.
Tier
II
and
Tier
III
studies
were
not
required
because
the
results
from
the
Tier
I
studies
were
sufficient
to
satisfy
guideline
requirements.
On
the
basis
of
the
studies
submitted,
it
was
considered
a
Toxicity
Category
III
pesticide
for
acute
oral
effects
due
to
the
amount
dosed
only,
and
Toxicity
Category
IV
for
dermal
and
primary
dermal
irritation
health
effects.
These
and
additional
toxicology
studies
are
summarized
below
and
in
more
detail
in
the
Product
Monograph
for
Pseudozyma
flocculosa
strain
PF
A22
UL
which
is
found
in
the
OPP
docket
number
OPP–
2002–
0233.
1.
Acute
oral
toxicity/
pathogenicity
study
(OPPTS
885.3050)
(Master
Record
Identification
(MRID)
numbers
451152–
04
and
453634–
01).
No
signs
of
toxicity
or
pathogenicity
were
noted
when
Sporodex
WP,
a
wettable
powder
formulation
containing
2.0%
(weight/
weight)
P.
flocculosa
strain
PF
A22
UL
was
administered
to
rats
via
the
oral
route.
In
an
acute
oral
toxicity
study,
groups
of
fasted
6
7
week
old
Fisher
344
rats
(12/
sex)
were
administered
a
single
oral
dose
of
Sporodex
WP
in
USP
sterile
water
for
injection
at
doses
of
5.8
x
10
8
colony
forming
units
(CFU)
per
animal
for
males
and
5.6
x
10
8
CFU
per
animal
for
females.
An
equal
number
of
animals
were
dosed
with
heat
killed
test
substance
and
four
animals/
sex
served
as
untreated
controls.
The
animals
were
then
observed
for
a
period
of
up
to
21
days
with
interim
scheduled
sacrifices.
No
effect
on
body
weight
gain
and
no
apparent
signs
of
treatment
related
toxicity,
infectivity
or
pathogenicity
were
observed
in
any
of
the
treated
animals
during
the
study
period.
Clearance
of
the
test
organism
occurred
by,
or
prior
to,
post
treatment
day
7.
Based
on
the
results
of
this
study,
Sporodex
L
and
its
active
ingredient,
P.
flocculosa,
is
not
considered
toxic
or
pathogenic
to
male
or
female
Fisher
344
rats.
2.
Acute
pulmonary
toxicity/
pathogenicity
study
(OPPTS
885.3150)
(MRID
numbers
451152–
06
and
453634–
01).
The
potential
toxicity
and
pathogenicity
of
P.
flocculosa
was
tested
by
observing
the
effects
following
a
single
intratracheal
instillation
of
3.2
x
10
7
CFU
of
the
test
organism
(TS)
to
each
of
12
male
and
12
female
CD
rats.
An
equal
number
of
animals
were
treated
with
heat
killed
test
substance
(KTS)
and
four
animals/
sex
served
as
untreated
controls.
Animals
were
observed
for
up
to
14
days
with
interim
scheduled
sacrifices.
A
total
of
15
rats
(3/
8
male
and
2/
8
female
TS
dosed
rats
and
6/
8
male
and
4/
8
female
KTS
dosed
rats)
died
on
days
2
and
3.
Laboured
respiration,
rough
hair
coat,
ocular
discharge
and
nasal
discharge
were
observed
in
both
TS
and
KTS
dosed
rats.
Hunched
posture
and
lethargy
were
also
observed
in
one
female
and
one
male
TS
dosed
rat,
respectively.
The
presence
or
absence
of
clinical
symptoms
were
not
indicative
of
spontaneous
deaths.
Due
to
the
large
number
of
spontaneous
deaths
and
a
number
of
missed
data
collections,
data
for
evaluating
effects
on
body
weights,
food
consumption
and
relative
organ
weight
were
limited.
At
the
end
of
the
14–
day
long
study,
administration
of
P.
flocculosa
did
not
have
a
statistically
significant
effect
on
body
weight.
Analyses
of
daily
food
consumption
and
relative
organ
weights
were
skewed
as
they
were
either
not
determined
or
did
not
include
animals
that
died
prior
to
their
scheduled
sacrifice
dates.
At
necropsy,
liver
lesions
and
lesions
and
enlargement
of
the
lung
and
spleen
were
observed
in
both
TS
and
KTSdosed
rats.
Confluent
dark
areas
were
also
seen
in
the
kidneys
of
a
single
male
TS
dosed
rat.
These
necropsy
findings
were
considered
consistent
with
the
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method
of
dosing
and
the
body's
normal
immunological
response
to
a
foreign
substance.
Pseudozyma
flocculosa
was
detected
in
the
lungs
and
lymph
nodes
and
the
stomach
and
small
intestine
of
TS
dosed
animals
only.
Counts
in
these
tissues
were
below
the
limit
of
detection
by
day
7.
Based
on
this
study,
P.
flocculosa
is
toxic,
but
not
infective
or
pathogenic,
at
the
dose
administered
when
introduced
by
the
intratracheal
route
to
male
and
female
CD
rats.
This
acute
pulmonary
study,
however,
was
originally
classified
as
unacceptable
due
to
major
deficiencies
in
the
collected
data
and
a
possible
dosing
error,
as
indicated
by
the
presence
of
the
microbial
pest
control
agent
(MPCA)
in
the
stomach
and
small
intestines
on
the
day
of
dosing.
However,
there
was
relevant
pathogenicity
information
that
indicated
clearance
of
the
MPCA.
Thus,
this
study
is
considered
to
be
supplemental
because
it
provides
acceptable
information
regarding
infectivity/
pathogenicity;
however,
this
study
does
not
differentiate
the
cause
of
certain
mortalities
in
the
TS
and
KTS
treatments.
A
confirmatory
acute
pulmonary
toxicity/
pathogenicity
study
using
the
technical
grade
of
the
active
ingredient
(TGAI)
and
testing
of
the
sterile
filtrate
from
the
production
culture
will
therefore
be
required
to
provide
this
additional
information
as
a
condition
of
registration.
3.
Acute
pulmonary
range
finding
study
(OPPTS
885.3150)
(MRID
numbers
451152–
07
and
453634–
01).
In
order
to
determine
whether
the
test
substance
(in
both
its
viable
and
non
viable
forms),
P.
flocculosa,
was
the
cause
of
the
deaths,
a
subsequent
acute
pulmonary
rangefinding
toxicity
study
was
conducted.
In
this
range
finding
study,
groups
of
young
adult
CD
rats
(5/
sex/
dose
level)
were
exposed
by
the
intratracheal
route
to
P.
flocculosa
(4.2
x
10
7
CFU/
mL)
in
ASTM
Type
1
water
at
doses
of
4.2
x
10
7
,
3.4
x
10
7
,
6.8
x
10
6
and
3.4
x
10
6
CFU/
animal.
Animals
were
then
observed
for
14
days.
There
were
no
mortalities
and
all
animals
gained
weight
during
the
study.
Rough
hair
coat
occurred
in
a
dose
dependent
manner
with
all
5
animals/
sex
exhibiting
this
symptom
at
the
highest
dose
of
4.2
x
10
7
CFU/
animal.
One
female
dosed
with
4.2
x
10
7
CFU
experienced
tremors,
closed
eyes
and
rough
hair
coat.
Pseudozyma
flocculosa
was
classified
as
being
of
slight
toxicity
(EPA
Toxicity
Category
IV)
based
on
adverse
effects
observed
in
some
test
animals.
This
acute
pulmonary
study
was
considered
supplemental.
According
to
USEPA
OPPTS
885.3150,
the
minimum
dose
is
10
8
units
of
the
MPCA
per
test
animal.
The
maximum
dose
level
used
in
this
study,
however,
was
only
4.2
x
10
7
CFU/
animal.
Furthermore,
infectivity
was
not
addressed;
however,
the
acute
pulmonary
toxicity/
pathogenicity
study
did
address
infectivity
sufficiently.
Consequently,
this
study
does
not
satisfy
the
guideline
requirement
for
an
acute
pulmonary
study
(OPPTS
885.3150)
in
the
rat.
EPA,
in
considering
the
two
studies
together,
believes
that
there
are
sufficient
data
with
which
to
determine
the
toxicity
and
pathogenicity
of
Pseudozyma
flocculosa.
As
any
potential
inhalation
risk
that
is
raised
by
these
studies
is
primarily
a
worker
risk,
EPA
is
requiring
that
a
respirator
be
worn
by
workers
to
limit
any
inhalation
exposures.
In
addition,
a
RestrictedEntry
Interval
(REI)
of
4
hours
is
required
for
early
entry
postapplication
workers
or
other
persons
entering
treated
greenhouses.
Finally,
a
confirmatory
acute
pulmonary
toxicity/
pathogenicity
study
using
the
TGAI
and
testing
of
the
sterile
filtrate
from
the
production
culture
will
be
required
as
a
condition
of
registration.
4.
Intraperitoneal
toxicity/
infectivity
study
(OPPTS
885.3200)
(MRID
numbers
451152–
08
and
453634–
01).
In
an
acute
intraperitoneal
toxicity/
infectivity
study,
groups
of
young
adult
CD
rats
(4/
sex/
scheduled
sacrifice
date)
were
exposed
by
the
intraperitoneal
route
to
an
undiluted
suspension
of
P.
flocculosa
(TS)
at
a
dose
of
3.5
x
10
7
CFU/
animal
(in
1.0
mL).
Animals
were
then
observed
for
up
to
14
days.
An
equal
number
of
young
adult
CD
rats
were
similarly
injected
with
heat
killed
test
substance
(KTS).
An
undosed
naive
control
(NC)
group
consisting
of
4
rats/
sex
was
also
included
in
the
study.
Cage
side
observation
for
clinical
symptoms
was
performed
daily
and
animal
body
weights
and
food
consumption
were
monitored.
No
unscheduled
deaths
occurred.
Designated
animals
from
the
TS
and
KTS
groups
were
sacrificed
on
days
0,
7,
and
14
and
gross
necropsies
were
performed.
The
NC
group
of
animals
was
sacrificed
and
necropsied
at
the
end
of
the
14–
day
study.
Infectivity
and
clearance
were
assessed
by
quantitatively
recovering
the
MPCA
from
the
blood,
lungs
and
lymph
nodes,
spleen,
kidneys,
liver,
heart,
stomach
and
small
intestine,
peritoneal
fluid,
caecum
and
brain.
No
adverse
clinical
signs
were
observed
at
any
point
of
the
study
in
any
of
the
groups
of
rats.
Body
weight
gain
of
TS
dosed
male
rats
was
significantly
decreased
while
this
group's
food
consumption
was
significantly
increased
compared
to
NC
animals.
There
was
no
significant
difference
between
KTS
dosed
and
NC
animals
in
terms
of
body
weight,
body
weight
gain
or
food
consumption.
Upon
necropsy
of
TS
and
KTS
dosed
animals,
white
nodules
and
higher
relative
spleen
weights
were
observed
and
attributed
to
a
normal
immune
response
to
a
foreign
substance.
The
detection
of
P.
flocculosa
in
the
peritoneal
fluid
lavage
of
TS
dosed
male
rats
was
consistent
with
the
method
of
administration.
Clearance
of
P.
flocculosa
from
all
other
tissues
and
fluids
occurred
by
day
7.
No
test
substance
was
detected
from
any
of
the
organs
of
the
KTS
dosed
or
NC
animals.
At
the
dose
administered,
P.
flocculosa
was
slightly
toxic
but
not
pathogenic
to
male
and
female
CD
rats
when
introduced
by
the
intraperitoneal
route.
5.
Acute
dermal
toxicity/
irritation
study
(OPPTS
885.3100)
(MRID
numbers
451152–
09
and
453634–
01).
In
an
acute
dermal
toxicity
study,
a
single
group
of
New
Zealand
White
rabbits
(5/
sex)
was
dermally
exposed
to
1.2
x
10
7
CFU
P.
flocculosa
(equivalent
to
approximately
0.82
0.90
g/
kg
bw
for
males
and
0.80
0.91
g/
kg
bw
for
females),
for
24
hours
to
an
area
equivalent
to
approximately
10%
of
the
dorsal
skin
surface.
Following
exposure,
the
animals
were
observed
for
a
period
of
14
days.
No
treatment
related
signs
of
toxicity
or
skin
irritation
were
observed
in
any
animal
during
the
14–
day
observation
period.
At
the
dose
administered,
P.
flocculosa
was
not
considered
toxic
or
irritating
to
the
skin.
6.
Primary
eye
irritation
study
(OPPTS
870.2400)
(MRID
numbers
451152–
10
and
453634–
01).
Administration
of
0.1
g
of
Sporodex
WP
to
the
eyes
of
rabbits
resulted
in
slight
conjunctival
redness
in
5/
6
animals
at
the
1–
hour
scoring
interval
and
in
2/
6
rabbits
at
the
24–
hour
scoring
interval.
By
the
48–
hour
scoring
interval,
all
signs
of
ocular
irritation
had
subsided.
There
were
no
other
adverse
clinical
symptoms
or
mortalities
during
the
7–
day
observation
period.
The
maximum
irritation
score
(MIS)
was
1.7
at
the
1–
hour
scoring
interval
and
the
maximum
average
score
(MAS)
was
0.22
over
the
24–,
48–
and
72–
hour
scoring
intervals.
Based
on
the
MAS,
Sporodex
WP
was
classified
as
minimally
irritating.
7.
Subchronic,
chronic
toxicity
and
oncogenicity.
Survival,
replication,
infectivity,
significant
toxicity
or
persistence
of
the
MPCA
was
not
observed
in
the
test
animals
treated
in
Tier
I
acute
oral,
pulmonary
and
intravenous
toxicity/
infectivity
tests.
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Consequently,
higher
tier
tests
involving
subchronic
and
chronic
testing,
oncogenicity
testing,
mutagenicity
and
teratogenicity
were
not
required
based
on
the
lack
of
concerns
following
analysis
of
Tier
I
test
results.
However,
a
genotoxicity
computer
search
for
Pseudozyma
flocculosa
was
conducted.
No
reports
of
mammalian
toxicity
were
found
in
standard
biological,
chemical
and
toxicological
abstracts.
The
applicant
included
computer
literature
search
results
to
a
number
of
keywords
such
as
pseudozyma;
tilletiopsis,
fate,
non
target,
carcin,
mutagen;
toxic,
pathogen,
antibiotic,
polyen;
sporothrix,
sporobolomyces,
rhodotorula,
phyllosphere
yeast;
carcinog
and
teratogen.
The
literature
search
covered
AGRICOLA,
Biological
Abstracts,
CAB
Abstracts,
CHEMTOX,
RTEX
and
AGRIS
databases
from
1980
to
1999.
8.
Hypersensitivity
(dermal
sensitization)
study
(OPPTS
870.2600).
The
applicant
has
also
submitted
an
acceptable
waiver
rationale
from
conducting
a
dermal
sensitization
study
based
on
the
assumption
that
most
microorganisms
contain
substances
that
could
elicit
a
hypersensitivity
response.
Pseudozyma
flocculosa
is
considered
a
potential
sensitizing
agent,
therefore,
the
statement,
``
POTENTIAL
SENSITIZER''
is
required
on
the
principal
display
panels
of
the
technical
and
end
use
formulation
labels.
The
use
of
personal
protective
equipment
will
also
be
required
to
mitigate
against
potential
dermal
sensitization
in
occupationally
exposed
workers/
handlers.
9.
Reports
of
hypersensitivity
incidents
(OPPTS
885.3400).
Skin
sensitizing
studies
are
not
considered
substitutes
for
timely
reports
of
hypersensitivity
incidents
subsequent
to
registration
approval.
No
adverse
effects
have
been
noted
among
researchers
who
have
worked
closely
with
P.
flocculosa
strain
PF
A22
UL
for
up
to
10
years.
The
applicant
will
be
expected
to
report
any
subsequent
findings
of
hypersensitivity
or
other
health
incidents
to
workers,
applicators,
or
bystanders
exposed
to
the
MPCA
as
a
condition
of
registration.
Incident
reports
are
to
include
details
such
as
a
description
of
the
MPCA
and
formulation,
frequency,
duration
and
routes
of
exposure
to
the
material,
clinical
observations,
and
any
other
relevant
information.
10.
Effects
on
the
immune
systems
(OPPTS
880.3800,
immune
response).
The
active
ingredient,
P.
flocculosa
strain
PF
A22
UL,
is
not
known
to
be
a
human
pathogen
nor
an
endocrine
disrupter.
The
submitted
toxicity/
pathogenicity
studies
in
the
rodent
indicate
that,
following
several
routes
of
exposure,
the
immune
system
is
still
intact
and
able
to
process
and
clear
the
active
ingredient.
Therefore,
no
adverse
effects
to
the
immune
systems
are
known
or
expected.
Based
on
this
rationale,
the
registrant
waiver
request
for
OPPTS
880.3800
(Immune
Response)
was
found
to
be
acceptable.
V.
Aggregate
Exposures
A.
Dietary
Exposure
In
examining
aggregate
exposure,
FFDCA
section
408
directs
EPA
to
consider
available
information
concerning
exposures
from
the
pesticide
residue
in
food
and
all
other
nonoccupational
exposures,
including
drinking
water
from
ground
water
or
surface
water
and
exposure
through
pesticide
use
in
gardens,
lawns,
or
buildings
(residential
and
other
indoor
uses).
1.
Food.
The
proposed
food
use
pattern
is
likely
to
result
in
residues
in
or
on
food
and
feed.
Residues
of
the
microbial
pesticide
are
likely
to
be
removed
from
treated
food
by
washing,
peeling,
cooking
and
processing.
Even
if
residues
are
not
removed,
however,
EPA
believes
that
dietary
exposure
to
the
microbial
agent
will
result
in
negligible
to
no
risk
to
consumers.
Although
Pseudozyma
species
are
ubiquitous
in
nature
and
have
been
isolated
from
a
wide
variety
of
plant
surfaces
including
leaf
litter,
clover,
maize
and
cucumber,
no
adverse
effects
from
dietary
exposure
have
been
attributed
to
natural
populations
of
Pseudozyma
flocculosa.
Furthermore,
no
adverse
effects
were
observed
at
maximum
hazard
dose
levels
in
the
acute
oral
toxicity/
pathogenicity
study
and
there
are
no
reports
of
known
mammalian
toxins
being
produced
by
the
MPCA.
Subchronic
and
chronic
dietary
exposure
studies
were
not
required
because
the
Tier
I
acute
oral
study
demonstrated
a
low
level
of
toxicity
and
no
pathogenicity
potential
for
the
active
microorganism.
Because
of
the
low
toxicity
profile
and
low
potential
exposure
of
the
MPCA
expected
for
the
proposed
uses,
there
is
no
concern
for
chronic
risks
posed
by
dietary
exposure
for
the
general
population
or
sensitive
subpopulations,
such
as
infants
and
children.
In
addition,
an
extensive
literature
search
yielded
no
reports
of
mammalian
toxins
being
produced
by
P.
flocculosa.
The
fungitoxic
unsaturated
C
17
fatty
acids
and
acyclic
norterpene
produced
by
the
MPCA
have
not
been
reported
to
be
toxic
to
mammals.
Neither
this
organism
nor
its
close
relatives
are
listed
among
microbial
contaminants
of
food.
Therefore,
EPA
expects
negligible
to
no
dietary
risk
from
exposure
to
naturally
occurring
and
isolated
P.
flocculosa
strain
PF
A22
UL
residues.
2.
Drinking
water
exposure.
Although
heavy
rainfall
likely
carries
P.
flocculosa
into
neighboring
aquatic
environments,
growth
and
survival
of
terrestrial
fungi
such
as
P.
flocculosa
is
limited
in
such
environments.
Thus,
it
is
not
expected
to
proliferate
in
aquatic
habitats
following
incidents
of
direct
or
indirect
exposure
(e.
g.,
runoff
from
treated
greenhouses).
Moreover,
P.
flocculosa
is
not
considered
to
pose
a
risk
to
humans
from
exposure
to
drinking
water
because
of
minimal
to
non
existent
toxicity.
Accordingly,
drinking
water
is
not
specifically
screened
for
P.
flocculosa
as
a
potential
indicator
of
microbial
contamination
or
as
a
direct
pathogenic
contaminant.
Both
percolation
through
soil
and
municipal
treatment
of
drinking
water
would
reduce
the
possibility
of
significant
transfer
of
residues
to
drinking
water.
Therefore,
the
potential
of
exposure
and
risk
via
drinking
water
is
likely
to
be
minimal
to
non
existent
for
this
MPCA.
B.
Other
Non
Occupational
Exposure
The
current
label
does
not
allow
applications
to
turf,
residential
or
recreational
areas.
Because
the
use
sites
are
in
greenhouses,
exposure
to
the
U.
S.
population
including
infants
and
children
in
school,
residential
and
daycare
facilities
is
likely
to
be
minimal
to
non
existent.
Consequently,
the
health
risk
posed
by
P.
flocculosa
strain
PF
A
22
UL
from
non
occupational
dermal
and
inhalation
exposures
to
the
general
public,
including
infants
and
children,
is
expected
to
be
negligible
to
non
existent.
Any
concerns
for
potential
inhalation
risk
is
for
occupational
exposures,
and
as
mentioned
previously,
will
be
mitigated
by
the
requirement
of
a
respirator
and
restriction
of
the
reentry
interval.
VI.
Cumulative
Effects
The
Agency
has
considered
available
information
on
the
cumulative
effects
of
such
residues
and
other
substances
that
have
a
common
mechanism
of
toxicity.
These
considerations
included
the
cumulative
effects
on
infants
and
children
of
such
residues
and
other
substances
with
a
common
mechanism
of
toxicity.
EPA
is
not
aware
of
any
other
bacteria
or
other
substances,
besides
naturally
occurring
strains
of
Pseudozyma,
that
share
a
common
mechanism
of
toxicity
with
this
active
ingredient.
Given
the
low
toxicity
and
pathogenicity
profile
of
P.
flocculosa,
even
if
there
were
any
other
substances
with
which
P.
flocculosa
shared
a
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common
mechanism
of
toxicity,
no
adverse
cumulative
effects
are
expected.
VII.
Determination
of
Safety
for
U.
S.
Population,
Infants
and
Children
Based
on
the
toxicology
data
submitted
and
other
relevant
information
in
the
Agency's
files,
there
is
reasonable
certainty
no
harm
will
result
from
aggregate
exposure
of
residues
of
Pseudozyma
flocculosa
strain
PF
A22
UL
to
the
U.
S.
population,
including
infants
and
children,
under
reasonably
foreseeable
circumstances
when
the
microbial
pesticide
product
is
used
as
labeled.
This
includes
all
anticipated
dietary
exposures
and
all
other
exposures
for
which
there
is
reliable
information.
The
Agency
has
arrived
at
this
conclusion
based
on
data
submitted
demonstrating
low
toxicity
at
the
maximum
doses
tested
and
a
lack
of
information
showing
adverse
effects
from
exposure
to
naturally
occurring
P.
flocculosa
as
well
as
a
consideration
of
the
product
as
currently
registered
and
labeled.
As
a
result,
EPA
establishes
an
exemption
from
tolerance
requirements
pursuant
to
FFDCA
408(
c)
and
(d)
for
residues
of
Pseudozyma
flocculosa
strain
PF
A22
UL
in
or
on
all
food
commodities.
FFDCA
section
408
provides
that
EPA
shall
apply
an
additional
tenfold
margin
of
exposure
(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
unless
EPA
determines
that
a
different
margin
of
exposure
(safety)
will
be
safe
for
infants
and
children.
Margins
of
exposure
(safety)
are
often
referred
to
as
uncertainty
(safety)
factors.
In
this
instance,
based
on
all
the
available
information,
the
Agency
concludes
that
P.
flocculosa
strain
PFA22
UL
is
practically
non
toxic
to
mammals,
including
infants
and
children.
Thus,
there
are
no
threshold
effects
of
concern
and,
as
a
result
the
provision
requiring
an
additional
margin
of
safety
does
not
apply.
Further,
the
provisions
of
consumption
patterns,
special
susceptibility,
and
cumulative
effects
do
not
apply.
As
a
result,
EPA
has
not
used
a
margin
of
exposure
(safety)
approach
to
assess
the
safety
of
P.
flocculosa
strain
PF
A22
UL.
VIII.
Other
Considerations
A.
Endocrine
Disruptors
EPA
does
not
have
any
information
regarding
endocrine
effects
of
this
microbial
pesticide
at
this
time.
There
is
no
evidence
to
suggest
that
use
of
P.
flocculosa
strain
PF
A22
UL
at
the
proposed
concentrations
will
adversely
affect
the
endocrine
system.
The
active
ingredient,
P.
flocculosa
strain
PF
A22
UL,
is
not
known
to
be
a
human
pathogen
nor
an
endocrine
disrupter.
The
submitted
toxicity/
pathogenicity
studies
in
the
rodent
indicate
that,
following
several
routes
of
exposure,
the
immune
system
is
still
intact
and
able
to
process
and
clear
the
active
ingredient.
Therefore,
no
adverse
effects
to
the
endocrine
systems
are
known
or
expected.
B.
Analytical
Method(
s)
As
part
of
the
standard
Quality
Control
measures,
the
Agency
is
requiring
microbial
assays
and
analytical
methods
to
identify
the
active
ingredient
and
potential
contaminants.
Analytical
methods
are
available
and
sufficient
to
identify
metabolites
and
contaminants
within
regulatory
levels.
All
batches
containing
potential
human
pathogens
are
to
be
destroyed.
The
MPCA
is
identified
using
a
combination
of
morphological
traits,
molecular
techniques
and
biological
activity.
The
identification
of
Pseudozyma
to
the
species
level
is
done
using
a
standard
mycological
approach.
Pseudozyma
species
can
be
differentiated
from
morphologically
similar
species
such
as
Hyalodendron,
Tilletiopsis,
Sporobolomyces
and
Sporothrix.
The
branching
conidiophores
of
Pseudozyma
can
be
confused
with
those
produced
by
Hyalodendron;
however,
the
whole
cell
hydrolysates
of
this
filamentous
basidiomycete
contain
xylose
which
is
not
found
in
Pseudozyma.
Tilletiopsis
and
Sporobolomyces,
other
saprophytic
wild
yeasts
on
aerial
plant
surfaces,
are
different
from
Pseudozyma
in
that
they
produce
spores
that
are
forcibly
discharged
upon
sporulation
(ballistospores).
Furthermore,
Tilletiopsis
species
produce
a
fungusdegrading
b
1,3
glucanase
that
is
not
produced
by
Pseudozyma
species.
The
genus
Sporothrix
represents
a
group
of
anamorphic
ascomycetous
yeasts
such
as
Sporothrix
schenckii
(type),
an
animal
pathogen.
Physiologically,
Pseudozyma
species
differ
greatly
from
Sporothrix
species.
Unlike
the
ascomycetous
Sporothrix
anamorphs,
P.
flocculosa
shows
positive
reactions
in
Diazonium
Blue
B
and
urease
tests
typical
of
all
basidiomycetous
yeasts.
Also,
the
major
ubiquinone
is
Q
10
rather
than
Q
8
or
Q
9
typical
of
the
ascomycetes,
Saccharomycopsis
and
Stephanoascus.
Strain
PF
A22
UL
can
be
differentiated
from
other
strains
of
P.
flocculosa
using
a
DNA
based
technique
called
multiplex
polymerase
chain
reaction
(multiplex
PCR).
The
multiplex
PCR
system
is
essentially
a
cocktail
of
different
primers
which
allows
the
rapid
assessment
of
numerous
DNA
fragments
in
a
single
PCR
amplification.
The
protocol
is
based
on
the
amplification
of
two
nuclear
regions,
(ITS
and
NS),
and
one
mitochondrial
region
(ML).
Those
regions
were
found
to
be
discriminant
in
the
identification
of
P.
flocculosa
PFA22
UL.
The
integrity
and
consistency
of
the
MPCA
is
ensured
by
two
methods.
The
first
method
is
a
DNA
based
PCR
technique
called
random
amplified
microsatellites
PCR
(RAMS).
Microsatellites
are
hypervariable
noncoding
regions
of
DNA
within
the
genome
that
evolve
more
rapidly
than
coding
DNA.
The
other
method
is
a
bioassay
that
measures
biological
activity.
The
biological
activity
of
the
MPCA
is
measured
by
the
inhibition
zone
created
when
a
susceptible
organism
is
grown
next
to
it.
Given
that
the
pest
controlled,
Sphaerotheca
species,
is
an
obligate
biotroph,
it
cannot
be
used
directly
in
this
bioassay.
Instead,
a
Phomopsis
species
is
used
because
its
sensitivity
to
P.
flocculosa's
fungitoxic
secretions
is
similar.
C.
Codex
Maximum
Residue
Level
There
are
no
Codex
Maximum
Residue
Levels
or
exemption
from
tolerances
for
the
microbial
active
ingredient
Pseudozyma
flocculosa
strain
PF
A22
UL.
IX.
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
of
1996,
EPA
will
continue
to
use
those
procedures,
with
appropriate
adjustments,
until
the
necessary
modifications
can
be
made.
The
new
section
408(
g)
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),
as
was
provided
in
the
old
FFDCA
sections
408
and
409.
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
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27,
2002
/
Rules
and
Regulations
178.
To
ensure
proper
receipt
by
EPA,
you
must
identify
docket
ID
number
OPP–
2002–
0233
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
November
26,
2002.
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.
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.
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.
3.
Copies
for
the
Docket.
In
addition
to
filing
an
objection
or
hearing
request
with
the
Hearing
Clerk
as
described
in
Unit
IX.
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.
2.
Mail
your
copies,
identified
by
docket
ID
number
OPP–
2002–
0233,
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.
In
person
or
by
courier,
bring
a
copy
to
the
location
of
the
PIRIB
described
in
Unit
I.
B.
2.
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).
X.
Regulatory
Assessment
Requirements
This
final
rule
establishes
an
exemption
from
the
tolerance
requirement
under
FFDCA
section
408(
d)
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
FFDCA
section
408(
d),
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
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retailers,
not
States.
This
action
does
not
alter
the
relationships
or
distribution
of
power
and
responsibilities
established
by
Congress
in
the
preemption
provisions
of
FFDCA
section
408(
n)(
4).
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.
XI.
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:
September
19,
2002.
James
Jones,
Acting
Director,
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
180.1221
is
added
to
subpart
D
to
read
as
follows:
§
180.1221
Pseudozyma
flocculosa
strain
PF
A22
UL;
exemption
from
the
requirement
of
a
tolerance.
An
exemption
from
the
requirement
of
a
tolerance
is
established
for
residues
of
Pseudozyma
flocculosa
strain
PF
A22
UL
in
or
on
all
food
commodities.
[FR
Doc.
02–
24651
Filed
9–
26–
02;
8:
45
am]
BILLING
CODE
6560–
50–
S
ENVIRONMENTAL
PROTECTION
AGENCY
40
CFR
Part
180
[OPP–
2002–
0229;
FRL–
7196–
8]
Fenamidone;
Pesticide
Tolerance
AGENCY:
Environmental
Protection
Agency
(EPA).
ACTION:
Final
rule.
SUMMARY:
This
regulation
establishes
tolerances
for
residues
of
fenamidone,
[4H
Imidazol
4
one,
3,5
dihydro
5
methyl
2(
methylthio)
5
phenyl
3
(phenylamino),
(S)],
in
or
on
lettuce,
head
at
15
ppm
and
lettuce,
leaf
at
20
ppm.
Aventis
CropScience
requested
these
tolerances
under
the
Federal
Food,
Drug,
and
Cosmetic
Act,
as
amended
by
the
Food
Quality
Protection
Act
of
1996.
Subsequent
to
the
filing
of
this
petition,
Bayer
Corporation
acquired
Aventis
CropScience
to
form
Bayer
CropScience.
Therefore,
the
registrant
is
now
Bayer
CropScience.
DATES:
This
regulation
is
effective
September
27,
2002.
Objections
and
requests
for
hearings,
identified
by
docket
control
number
OPP–
2002–
0229,
must
be
received
on
or
before
November
26,
2002.
ADDRESSES:
Written
objections
and
hearing
requests
may
be
submitted
by
mail,
in
person,
or
by
courier.
Please
follow
the
detailed
instructions
for
each
method
as
provided
in
Unit
VI.
of
the
SUPPLEMENTARY
INFORMATION.
To
ensure
proper
receipt
by
EPA,
your
objections
and
hearing
requests
must
identify
docket
control
number
OPP–
2002–
0229
in
the
subject
line
on
the
first
page
of
your
response.
FOR
FURTHER
INFORMATION
CONTACT:
By
mail:
Cynthia
Giles
Parker,
Registration
Division
(7505C),
Office
of
Pesticide
Programs,
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460;
telephone
number:
(703)
305–
7740;
e
mail
address:
giles
parker.
cynthia@
epa.
gov.
SUPPLEMENTARY
INFORMATION:
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:
Categories
NAICS
codes
Examples
of
potentially
affected
entities
Industry
111
112
311
32532
Crop
production
Animal
production
Food
manufacturing
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
the
table
could
also
be
affected.
The
North
American
Industrial
Classification
System
(NAICS)
codes
have
been
provided
to
assist
you
and
others
in
determining
whether
or
not
this
action
might
apply
to
certain
entities.
If
you
have
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
Additional
Information,
Including
Copies
of
this
Document
and
Other
Related
Documents?
1.
Electronically.
You
may
obtain
electronic
copies
of
this
document,
and
certain
other
related
documents
that
might
be
available
electronically,
from
the
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Internet
Home
Page
at
http://
www.
epa.
gov/.
To
access
this
document,
on
the
Home
Page
select
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Regulations,
''
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''
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Register—
Environmental
Documents.
''
You
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Register
listings
at
http://
www.
epa.
gov/
fedrgstr/.
A
frequently
updated
electronic
version
of
40
CFR
part
180
is
available
at
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www.
access.
gpo.
gov/
nara/
cfr/
cfrhtml
00/
Title
40/
40cfr180
00.
html,
a
VerDate
Sep<
04>
2002
16:
57
Sep
26,
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Jkt
197001
PO
00000
Frm
00114
Fmt
4700
Sfmt
4700
E:\
FR\
FM\
27SER1.
SGM
27SER1
| epa | 2024-06-07T20:31:43.333035 | regulations | {
"license": "Public Domain",
"url": "https://downloads.regulations.gov/EPA-HQ-OPP-2002-0233-0001/content.txt"
} |
EPA-HQ-OPP-2002-0233-0002 | Supporting & Related Material | "2002-09-13T04:00:00" | null | Product
Monograph
Pseudozyma
flocculosa
strain
PF
A22
UL
(PC
Code
119196)
Pseudozyma
flocculosa
strain
PF
A22
UL
(TGAI)
SPORODEX
L
(EP)
The
active
ingredient
Pseudozyma
flocculosa
strain
PF
A22
UL
and
associated
end
use
product
SPORODEX
L,
for
the
control
of
powdery
mildew
on
roses
and
cucumbers,
are
proposed
for
temporary
registration
under
Section
17
of
the
Pest
Control
Products
Regulations
(Canada)
and
a
conditional
registration
under
Section
3(
c)(
7)(
C)
of
the
Federal
Insecticide
Fungicide
and
Rodenticide
Act
(United
States).
This
Product
Monograph
provides
a
summary
of
data
reviewed
and
the
rationale
for
the
proposed
Section
17
(Canada)
and
Section
3(
c)(
7)(
C)
(U.
S.)
registration
of
these
products.
September
2002
Product
Monograph
Pseudozyma
flocculosa
strain
PF
A22
UL
Foreword
The
submissions
for
the
registration
of
the
technical
grade
active
ingredient,
Pseudozyma
flocculosa
strain
PF
A22
UL,
and
its
end
use
product,
SPORODEX
L,
manufactured
by
Plant
Products
Co.,
have
been
jointly
reviewed
by
Health
Canada's
Pest
Management
Regulatory
Agency
(PMRA)
and
the
U.
S.
Environmental
Protection
Agency
(EPA).
Plant
Products
Co.
was
granted
a
temporary
registration
(Section
17)
in
Canada
on
June
3,
2002
for
use
of
P.
flocculosa
strain
PF
A22
UL,
and
its
end
use
product,
SPORODEX
L.
SPORODEX
L
is
a
biological
fungicide,
containing
1.
3%
(w/
w)
P.
flocculosa
strain
PF
A22
UL,
intended
for
the
control
of
powdery
mildew
on
greenhouse
roses
and
cucumbers.
The
active
microorganism,
Pseudozyma
flocculosa,
is
a
naturally
occurring
fungus
and
is
not
currently
registered
in
the
U.
S.
or
Canada.
Microbial
pest
control
agents
are
increasingly
being
investigated
for
use
as
alternatives
to
conventional
pesticides
because
they
are
thought
to
pose
a
lower
potential
risk
to
human
health
and
the
environment,
compared
with
conventional
pesticides.
SPORODEX
L
represents
a
potential
biological
replacement
for
chemical
fungicides.
The
active
ingredient,
Pseudozyma
flocculosa
strain
PF
A22
UL,
and
the
formulated
product
SPORODEX
L,
for
control
of
powdery
mildew
on
greenhouse
grown
roses
and
cucumbers
have
been
granted
temporary
registration
pursuant
to
Section
17
of
the
Pest
Control
Products
Regulations
(Canada)
and
a
conditional
registration
pursuant
to
Section
3(
c)(
7)(
C)
of
the
Federal
Insecticide
Fungicide
and
Rodenticide
Act
(FIFRA)
on
the
condition
that
confirmatory
data
are
submitted.
A
summary
of
PMRA's
and
EPA's
findings
in
support
of
this
decision
is
found
in
this
Monograph.
A
copy
of
PMRA's
Sporodex
Regulatory
Note
can
be
found
on
the
PMRA
internet
site
at
the
following
address:
http://
www.
hc
sc.
gc.
ca/
pmra
arla/
english/
pdf/
reg/
reg2002
02
e.
pdf.
Product
Monograph
Pseudozyma
flocculosa
strain
PF
A22
UL
3
Table
of
Contents
Chapter
1
Theactivemicro
organism,
itspropertiesanduses................
7
1.
1
Identity
of
the
active
micro
organism
and
preparation
containing
it
.
.
.
7
Table1.
1
1
TGAIIdentification
............................
7
1.2
Physical
and
chemical
properties
of
technical
and
end
use
product(
s)
.
.
8
Table
1.
2
1
Technical
Product:
Pseudozyma
flocculosa
strain
PF
A22UL.............................................
8
Table1.
2
2
End
UseProduct:
SPORODEXL..................
8
1.
3
Detailsofusesandfurtherinformation.........................
8
Chapter
2
Methodsofanalysis.......................................
9
2.
1
Methodsfor
analysisofthemicro
organismasmanufactured........
9
2.
1.
1
Methodsfor
identificationofthemicro
organism.................
9
2.
1.
2
Methodsfor
establishmentofpurityofseedstock
...............
10
2.
1.
3
Methods
to
define
the
content
of
the
micro
organism
in
the
manufactured
material
used
for
the
production
of
formulated
products
.....................................................
11
2.1.4
Methods
for
the
determination
of
relevant
impurities
in
the
manufactured
material...............................................
11
2.
1.
5
Methods
to
show
absence
of
any
human
and
mammalian
pathogens
.
.
12
2.
1.
6
Methods
to
determine
storage
stability,
shelf
life
of
the
micro
organism
.....................................................
12
2.
2
Methods
to
determine
and
quantify
residues
(viable
or
non
viable)
of
the
activemicro
organismandrelevantmetabolites
.................
12
Chapter
3
Impactonhumanhealthandsafety
..........................
12
3.
1
Toxicityandinfectivitysummaries(
Tier
I
acutestudies)
..........
13
3.
1.
1
Acuteoraltoxicity/
pathogenicitystudy
......................
13
3.
1.
2
Acutepulmonarytoxicity/
pathogenicitystudy
.................
13
3.
1.
3
Acutepulmonaryrange
findingstudy.........................
14
3.
1.
4
Intraperitonealtoxicity/
infectivitystudy......................
15
3.
1.
5
Acutedermaltoxicity/
irritationstudy........................
16
3.
1.
6
Primaryeyeirritationstudy
................................
16
3.
1.
7
Subchronic,
chronictoxicityandoncogenicity
..................
16
3.
1.
8
Effects
on
the
immune
and
endocrine
systems
..................
17
Table
3.
1
Summary
of
toxicity
and
pathogenicity
studies
with
Pseudozyma
flocculosa
.............................................
17
3.
1.
9
Integratedtoxicityandinfectivitysummary
....................
19
3.
2
Hypersensitivityincidents
.................................
21
3.3
Impact
on
human
and
animal
health
arising
from
exposure
to
the
active
substanceor
toimpuritiescontainedinit
......................
21
3.
3.
1
Occupationalandbystanderexposureassessment
...............
21
Chapter
4
Residues
..............................................
22
Product
Monograph
Pseudozyma
flocculosa
strain
PF
A22
UL
4
4.
1
Residuesrelevanttoconsumer
safety.........................
22
4.
1.
1
Dietaryexposureandriskassessment
........................
22
4.
1.
2
Drinkingwaterexposureandriskassessment...................
23
4.
1.
3
Maximum
residue
limits
...................................
23
4.2
Aggregate
exposure
from
multiple
routes
including
oral,
dermal,
and
inhalation..............................................
23
4.
2.
1
Oral..................................................
23
4.
2.
2
Dermal
...............................................
24
4.
2.
3
Inhalation
.............................................
24
4.
3
Cumulativeeffects.......................................
24
4.
4
DeterminationofsafetyforU.
S.
population,
infantsandchildren....
24
Chapter
5
Fateandbehaviourintheenvironment........................
25
Chapter
6
Effectsonnon
targetspecies...............................
25
6.
1
Birds
.................................................
25
6.
1.
1
Avianoral
.............................................
25
6.
1.
2
Avianpulmonary/
inhalation/
injection.........................
25
6.
2
Wildmammals..........................................
26
6.
3
Fish..................................................
26
6.
3.
1
Freshwater
fishandestuarine/
marineanimals...................
26
6.
4
Arthropods
............................................
27
6.
4.
1
Terrestrialarthropods
....................................
27
6.
4.
2
Aquaticarthropods
......................................
27
6.
5
Non
arthropodinvertebrates
...............................
27
6.
6
Microorganisms.........................................
28
6.
7
Plants
................................................
28
6.
7.
1
Aquaticplants
..........................................
28
6.
7.
2
Terrestrialplants
........................................
28
Table
6.
1
Risks
of
Pseudozyma
flocculosa
strain
PF
A22
UL
to
non
target
organisms
.............................................
29
6.
8
Integratedenvironmentaltoxicologysummary..................
30
Chapter
7
Efficacy
data
and
information
..............................
30
7.
1
Effectiveness
...........................................
30
7.
1.
1
Intendeduse
...........................................
30
7.
1.
2
Modeofaction
.........................................
31
7.
1.
3
Crops
................................................
31
7.
1.
4
Effectivenessagainstpest
.................................
31
7.
1.
5
Totalsprayvolume
......................................
32
7.
2
Phytotoxicity
to
target
plants
(including
different
cultivars),
or
to
target
plant
products
(OECD
7.
4)
....................................................................
33
Product
Monograph
Pseudozyma
flocculosa
strain
PF
A22
UL
5
7.3
Observations
on
undesirable
or
unintended
side
effects
e.
g.
on
beneficial
and
other
non
target
organisms,
on
succeeding
crops,
other
plants
or
parts
of
treated
plants
used
for
propagating
purposes
(e.
g.
seed,
cutting,
runners)...............................................
33
7.3.1
Impact
on
succeeding
crops
................................
33
7.3.2
Impact
on
adjacent
crops
..................................
33
7.
3.
3
Impact
on
seed
viability
...................................
33
7.
4
Economics
.............................................
33
7.
5
Sustainability
...........................................
34
7.
5.
1
Surveyofalternatives
....................................
34
7.
5.
1.
1
Non
chemicalcontrolpractices
.............................
34
7.
5.
1.
2
ChemicalControlPractices
................................
34
Table7.
5
1
Alternativediseasecontrolproducts
...............
35
7.
5.
2
Compatibility
with
current
management
practices
including
IPM
....
35
7.
5.
3
Contributiontoriskreduction
..............................
35
7.
5.
4
Information
on
the
occurrence
or
possible
occurrence
of
the
development
ofresistance
...........................................
36
7.
6
Conclusions............................................
36
7.
6.
1
Summary..............................................
36
Table7.
6
1
Summaryoflabelproposalsandrecommendations...............
37
Chapter
8
Overallconclusions
......................................
37
8.
1
Productcharacterizationandanalysis.........................
37
8.
2
Toxicityandinfectivity
...................................
38
8.
3
Exposure..............................................
38
8.
4
Foodandfeedresidues
...................................
38
8.
5
Environmentalassessment
.................................
39
8.6
Efficacy
assessment
......................................
39
Chapter
9
Riskmanagementconsiderations
............................
40
9.
1
Publicinterestfinding
....................................
40
9.
2
Determination
of
3(
c)(
7)(
C)
eligibility
........................
40
9.
3
Termsandconditionsofregistration
.........................
42
9.
4
Tolerance
.............................................
43
9.
5
Codexharmonization.....................................
43
9.
6
Riskmigitation
.........................................
43
9.
7
Endangeredspecies
......................................
44
9.
8
Labelsandlabeling
......................................
44
9.
8.
1
End
useproduct
........................................
44
9.
8.
2
Manufacturing
useproduct................................
50
Chapter
10
Listofabbreviations
.....................................
53
Product
Monograph
Pseudozyma
flocculosa
strain
PF
A22
UL
6
Product
Monograph
Team
U.
S.
EPA/
Office
of
Pesticide
Programs/
Biopesticides
and
Pollution
Prevention
Division:
Sharlene
Matten,
Ph.
D.
Biologist,
Regulatory
Action
Leader
Ibrahim
Barsoum,
Ph.
D.
Microbiologist,
Product
Characterization
and
Human
Health
Analysis
John
Kough,
Ph.
D.
Biologist,
Senior
Scientist
Zigfridas
Vaituzis,
Ph.
D.
Microbiologist,
Environmental
Fate
and
Effects
Analysis
Barbara
Mandula,
Ph.
D.
Biologist
Suzanne
Krolikowski,
J.
D.
Office
of
General
Counsel
Product
Monograph
Pseudozyma
flocculosa
strain
PF
A22
UL
7
Chapter
1
The
active
micro
organism,
its
properties
and
uses
1.1
Identity
of
the
active
micro
organism
and
preparation
containing
it
Table
1.
1
1
TGAI
Identification
Active
Micro
organism
Pseudozyma
flocculosa
strain
PF
A22
UL
Function
Biological
fungicide
Binomial
name:
Pseudozyma
flocculosa
(Traquair,
J.
A.,
Shaw,
L.
A.,
and
Jarvis,
W.
R.)
Boekhout,
T.
andTraquair,
J.
A.
strainPFA22
UL
Taxonomic
designation:
Kingdom:
Phylum:
Genus:
Species:
Strain:
Fungi
Deuteromycotina
Dematiaceous
Asexual
Fungi
Pseudozyma
flocculosa
PF
A22
UL
Nominal
purity
of
active
Pseudozyma
flocculosa
strain
PF
A22
UL
(TGAI)
consists
of
100%
active
ingredient
in
spent
fermentation
medium
corresponding
to
a
minimum
of
3
×
10
8
colony
forming
units
(CFU)/
mL
of
Pseudozyma
flocculosa
strain
PF
A22
UL.
1.3%
w/
w
(equivalent
to
a
min.
3
×
10
8
CFU/
mL)
in
SPORODEX
L
(EP).
Identity
of
relevant
impurities
of
toxicological,
environmental
and/
or
other
significance
A
stock
culture
is
rejected
if
biological
activity
is
altered
or
if
mutations
are
detected.
If
any
contamination
is
found
in
the
media
prior
to
inoculation,
the
media
is
discarded.
If
contamination
exceeds
the
product
release
standards
for
total
aerobic
flora
(<
1000
CFU/
mL),
enterobacteria
(<
10
CFU/
mL),
fecal
streptococci
(absence
in
1
gram),
Staphylococcus
aureus
(absence
in
1
gram),
coliforms
(<
10
CFU/
mL),
Escherichia
coli
(absence
in
1
gram)
and
Salmonella
(absence
in
1
gram),
the
product
is
discarded.
No
mammalian
toxins
are
known
to
be
produced
by
strain
PF
A22
UL.
Product
Monograph
Pseudozyma
flocculosa
strain
PF
A22
UL
8
1.2
Physical
and
chemical
properties
of
technical
and
end
use
product(
s)
Table
1.
2
1
Technical
Product:
Pseudozyma
flocculosa
strain
PF
A22
UL
Not
applicable.
SPORODEX
L
is
manufactured
following
a
continuous
manufacturing
process
that
does
not
involve
an
intermediate
stand
alone
technical
product.
Table
1.
2
2
End
Use
Product:
SPORODEX
L
Property
SPORODEX
L
Physical
state
at
25
C
Liquid
Colour
Beige
Odour
Faint
mushroom
smell
pH
in
distilled
water
6.
4
6.
8
Density
1.
05
g/
mL
Viscosity
51
centipoise
Corrosion
character
None
All
formulants
in
Sporodex
L
are
either
of
food
grade
quality
or
are
considered
relatively
nontoxic
(i.
e.,
EPA
list
3,
4A
or
4B).
1.3
Details
of
uses
and
further
information
SPORODEX
L
is
an
end
use
product
containing
the
active
ingredient
Pseudozyma
flocculosa
strain
PF
A22
UL.
SPORODEX
L
is
a
liquid
proposed
for
use
as
a
biological
fungicide
to
control
powdery
mildew
fungi
(Sphaerotheca
pannosa
var.
rosae
and
Sphaerotheca
fuliginea)
on
greenhouse
food
and
non
food
crops,
namely
cucumber
and
roses.
SPORODEX
L
is
to
be
applied
in
an
aqueous
solution
prepared
by
diluting
500
mL
of
product
per
100
L
of
water
(or
64
U.
S.
fl
oz
per
100
U.
S.
gallons
of
water)
(equivalent
to
approximately
10
5
to
10
6
CFU/
mL).
A
wetting
agent
is
added
to
a
final
concentration
of
0.
02%
to
improve
its
efficacy.
Plants
are
to
be
treated
beginning
when
environmental
conditions
favour
development
of
powdery
mildew
or
at
the
first
sign
of
the
disease.
Plants
are
to
be
sprayed
to
the
point
of
run
off
at
weekly
intervals.
Up
to
1500
L
of
spray
solution
is
to
be
applied
per
hectare
(or
150
U.
S.
gallons
of
spray
mixture
per
acre)
for
cut
roses
or
cucumbers
or
about
1000
L/
ha
(or
100
U.
S.
gallons
per
acre)
for
potted
roses.
After
application,
the
relative
humidity
is
to
be
maintained
above
70%
for
12
hours.
Pseudozyma
flocculosa
was
isolated
in
1986
from
the
leaves
of
red
clover,
Trifolium
pratense,
infected
with
powdery
mildew,
Erysiphe
polygoni,
by
researchers
at
Agriculture
and
Agri
Food
Canada,
Harrow,
Ontario.
Initially,
this
organism
was
erroneously
identified
as
a
new
Product
Monograph
Pseudozyma
flocculosa
strain
PF
A22
UL
9
ascomycetous
yeast
with
an
anamorphic
state
in
the
broad
genus
Sporothrix
and
a
teleomorphic
state
in
the
genus
Stephanoascus.
In
1995,
its
taxon
was
changed
to
Pseudozyma
flocculosa
following
ribosomal
DNA
analysis.
The
genus
Pseudozyma
contains
other
smut
like
anamorphs,
including
P.
rugulosa
(formerly
Sporothrix
rugulosa).
Pseudozyma
flocculosa
is
a
phyllosphere
epiphyte
and
hyperparasite
of
primarily
powdery
mildew
but
has
been
isolated
in
association
with
other
leaf
surface
moulds.
It
is
widely
distributed
in
North
America
(Canada
and
USA)
and
in
Europe
on
aerial
plant
surfaces
in
field
or
greenhouse
agricultural
ecosystems.
Pseudozyma
flocculosa
antagonizes
a
number
of
different
powdery
mildew
fungi
(Sphaerotheca
pannosa
var.
rosae,
Sphaerotheca
fulginea,
Erysiphe
graminis
var.
tritici
and
Erysiphe
polygoni)
on
many
different
plants
in
greenhouse
and
field
environments
when
the
relative
humidity
is
greater
or
equal
to
70%.
This
fungus
is
a
necrotroph
mycoparasite
that
kills
susceptible
target
host
cells
upon
contact
or
in
close
proximity.
Rapid
death
and
collapse
of
host
cells
without
penetration
is
brought
about
by
the
secretion
of
three
fungitoxic
unsaturated
C
17
fatty
acids
(9
heptadecenoic
acid,
6
methyl
9
heptadecenoic
acid
and
4
methyl
7,
11
heptadecadienoic
acid)
and
an
acyclic
norterpene
(2,
6,
10,
14,
18
pentamethyl
2,
6,
8,
10,
12,
14,
17
nonadecaheptene
1,
19
diol).
The
fungitoxins
disrupt
susceptible
plasma
membranes
and
cytoplasmic
organelles
within
30
minutes
of
exposure.
The
inhibitory
response
includes
a
loss
of
proteins
and
electrolytes.
After
24
hours,
the
host
cells
rapidly
collapse
and
die
as
a
result
of
the
activity
of
the
fungitoxins
on
the
host
cell's
membranes
and
lipids.
Sensitivity
to
the
unsaturated
C
17
free
fatty
acids
is
related
to
a
high
degree
of
unsaturation
of
phospholipid
fatty
acids
and
a
low
proportion
of
sterols.
Chapter
2
Methods
of
analysis
2.1
Methods
for
analysis
of
the
micro
organism
as
manufactured
2.1.1
Methods
for
identification
of
the
micro
organism
Appropriate
methodologies
for
detection,
isolation
and
enumeration
of
P.
flocculosa
strain
PFA22
UL
were
detailed
by
the
applicant.
The
microbial
pest
control
agent
(MPCA)
is
identified
using
a
combination
of
morphological
traits,
molecular
techniques
and
biological
activity.
The
identification
of
Pseudozyma
to
the
species
level
is
done
using
a
standard
mycological
approach.
Pseudozyma
species
can
be
differentiated
from
morphologically
similar
species
such
as
Hyalodendron,
Tilletiopsis,
Sporobolomyces
and
Sporothrix.
The
branching
conidiophores
of
Pseudozyma
can
be
confused
with
those
produced
by
Hyalodendron;
however,
the
whole
cell
hydrolysates
of
this
filamentous
basidiomycete
contain
xylose
which
is
not
found
in
Pseudozyma.
Tilletiopsis
and
Sporobolomyces,
other
saprophytic
wild
yeasts
on
aerial
plant
surfaces,
are
different
from
Pseudozyma
in
that
they
produce
spores
that
are
forcibly
discharged
upon
sporulation
(ballistospores).
Furthermore,
Tilletiopsis
species
produce
a
fungus
degrading
1,
3
glucanase
that
is
not
produced
by
Pseudozyma
species.
The
genus
Sporothrix
represents
a
group
of
anamorphic
ascomycetous
yeasts
such
as
Sporothrix
schenckii
(type),
an
animal
pathogen.
Physiologically,
Pseudozyma
species
differ
greatly
from
Sporothrix
species.
Unlike
the
ascomycetous
Sporothrix
anamorphs,
P.
flocculosa
shows
positive
reactions
in
Diazonium
Blue
Product
Monograph
Pseudozyma
flocculosa
strain
PF
A22
UL
10
B
and
urease
tests
typical
of
all
basidiomycetous
yeasts.
Also,
the
major
ubiquinone
is
Q
10
rather
than
Q
8
or
Q
9
typical
of
the
ascomycetes,
Saccharomycopsis
and
Stephanoascus.
Strain
PF
A22
UL
can
be
differentiated
from
other
strains
of
P.
flocculosa
using
a
DNA
based
technique
called
multiplex
polymerase
chain
reaction
(multiplex
PCR).
The
multiplex
PCR
system
is
essentially
a
cocktail
of
different
primers
which
allows
the
rapid
assessment
of
numerous
DNA
fragments
in
a
single
PCR
amplification.
The
protocol
is
based
on
the
amplification
of
two
nuclear
regions,
(ITS
and
NS),
and
one
mitochondrial
region
(ML).
Those
regions
were
found
to
be
discriminant
in
the
identification
of
P.
flocculosa
PF
A22
UL.
The
integrity
and
consistency
of
the
MPCA
is
ensured
by
two
methods.
The
first
method
is
a
DNA
based
PCR
technique
called
random
amplified
microsatellites
PCR
(RAMS).
Microsatellites
are
hypervariable
non
coding
regions
of
DNA
within
the
genome
that
evolve
more
rapidly
than
coding
DNA.
The
other
method
is
a
bioassay
that
measures
biological
activity.
The
biological
activity
of
the
MPCA
is
measured
by
the
inhibition
zone
created
when
a
susceptible
organism
is
grown
next
to
it.
Given
that
the
pest
controlled,
Sphaerotheca
species,
is
an
obligate
biotroph,
it
cannot
be
used
directly
in
this
bioassay.
Instead,
a
Phomopsis
species
is
used
because
its
sensitivity
to
P.
flocculosa's
fungitoxic
secretions
is
similar.
2.1.2
Methods
for
establishment
of
purity
of
seed
stock
The
mother
colony
is
maintained
as
slant
cultures
at
4
C,
and
as
freeze
dried
cultures
stored
at
20
C.
The
genetic
stability
of
those
cultures
is
verified
at
least
once
every
six
months
using
RAMS
PCR
(see
Section
2.
1.
1
for
details).
The
frequency
of
this
analysis
is
to
be
increased
accordingly
if
the
mother
colony
begins
to
show
signs
of
reduced
yield.
No
methods
for
establishing
the
purity
of
the
mother
colonies
were
submitted;
however,
sufficient
microbial
contaminant
screening
methods
were
proposed
for
the
production
of
Pseudozyma
flocculosa
strain
PF
A22
UL
and
SPORODEX
L.
There
are
essentially
three
types
of
screening
methods
involved
in
the
production
of
Pseudozyma
flocculosa
strain
PF
A22
UL
and
SPORODEX
L,
namely
pre
fermentation
sterility
tests,
MPCA
integrity
tests,
and
microbial
contaminant
screening
tests.
Prior
to
inoculation,
all
media
are
screened
for
the
presence
of
microbial
contaminants
by
plating
aliquots
of
the
medium
onto
plate
count
agar
(PCA)
plates.
If
any
microbial
contamination
is
found,
the
medium
is
discarded.
Similarly,
all
cultures
are
monitored
for
MPCA
integrity
and
microbial
contamination
by
plating
various
dilutions
onto
potato
dextrose
agar
(PDA)
plates.
If
significant
microbial
contamination
is
detected,
the
culture
is
rejected.
In
case
of
abnormal
colony
morphology
on
PDA,
a
multiplex
PCR
analysis
(see
Section
2.
1.
1
for
details)
is
performed
to
properly
identify
the
afflicted
colonies.
Furthermore,
the
bioassay
method
described
in
Section
2.
1.
1
is
done
prior
to
product
formulation
to
verify
its
biological
control
potential.
Microbial
contaminant
screening
tests
are
performed
on
the
formulated
end
use
product
prior
to
packaging.
They
are
monitored
by
culturing
dilutions
of
formulated
end
use
products
onto
or
into
various
media.
The
groups
of
microbial
contaminants
tested
and
their
proposed
product
release
standards
include
total
aerobic
flora
(<
1000
CFU/
mL),
enterobacteria
Product
Monograph
Pseudozyma
flocculosa
strain
PF
A22
UL
11
(<
10
CFU/
mL),
fecal
streptococci
(absence
in
1
gram),
Staphylococcus
aureus
(absence
in
1
gram),
coliforms
(<
10
CFU/
mL),
Escherichia
coli
(absence
in
1
gram)
and
Salmonella
(absence
in
1
gram).
If
any
of
the
proposed
bioburden
limits
are
exceeded,
the
entire
batch
is
rejected.
2.1.3
Methods
to
define
the
content
of
the
micro
organism
in
the
manufactured
material
used
for
the
production
of
formulated
products
The
concentration
of
Pseudozyma
flocculosa
strain
PF
A22
UL
is
determined
by
measuring
the
number
of
viable
colony
forming
units
(CFU)
per
millilitre
of
formulated
product.
For
this
assay,
a
25
mL
sample
is
diluted
in
peptone,
then
plated
onto
PDA.
Microscopic
observations
made
on
the
formulated
product
ensure
that
the
MPCA
is
under
the
proper
conidial
form.
According
to
product
specifications,
the
guarantee
is
expressed
as
greater
than
3
×
10
8
CFU/
mL.
The
biological
control
potential
of
the
MPCA
is
measured
prior
to
product
formulation
using
the
bioassay
method
described
in
Section
2.
1.
1.
2.1.4
Methods
for
the
determination
of
relevant
impurities
in
the
manufactured
material
No
known
or
suspected
toxic
material
is
produced
by
Pseudozyma
flocculosa
strain
PF
A22
UL
during
the
fermentation
process.
Although
the
majority
of
the
manufacturing
process
is
designed
to
avoid
microbial
contamination,
some
contamination
can
occur
as
the
end
use
product
is
centrifuged
and
formulated
under
non
sterile
conditions.
As
mentioned
in
Section
2.
1.
2,
there
are
various
methods
to
monitor
the
levels
of
various
groups
of
contaminating
microorganisms
in
the
formulated
product.
Quality
control
data
from
five
batches
(1
commercial
scale
and
4
pilot
scale
batches)
of
SPORODEX
L
were
assessed
using
the
microbial
contaminant
screening
methods
described
in
Section
2.
1.
1.
The
total
aerobic
flora
in
SPORODEX
L
ranged
from
150
to
2
×
10
4
CFU/
mL.
Both
the
enterobacteria
and
fecal
coliform
counts
were
0
CFU/
mL
and
no
enterococci,
E.
coli,
Staphylococcus
aureus,
orSalmonella
were
detected
in
SPORODEX
L.
It
must
be
noted
that
two
of
the
five
batches,
including
the
only
commercial
batch,
were
destroyed
due
to
microbial
contamination.
In
one
of
those
batches,
the
total
aerobic
flora
exceeded
the
product
release
standard
for
this
group
of
contaminants,
i.
e.,
<
10
3
CFU/
mL.
In
the
other,
significant
microbial
contamination
was
detected
during
a
MPCA
integrity
test
on
PDA.
Both
of
those
batches
were
rejected.
Given
that
two
batches
were
destroyed
as
a
result
of
microbial
contamination,
the
submission
of
certificates
of
analysis
for
all
production
batches
of
SPORODEX
L
will
be
required
as
a
condition
of
registration
by
the
Canadian
Pest
Management
Regulatory
Agency
(PMRA)
and
the
U.
S.
Environmental
Protection
Agency
(EPA).
Product
Monograph
Pseudozyma
flocculosa
strain
PF
A22
UL
12
2.1.5
Methods
to
show
absence
of
any
human
and
mammalian
pathogens
As
discussed
in
Section
2.
1.
2,
the
quality
assurance
program
implemented
by
the
applicant
for
the
production
of
SPORODEX
L
requires
the
destruction
of
the
batch
if
any
of
those
product
release
standards
(including
animal
and
human
pathogens)
are
exceeded
in
the
formulated
product.
2.1.6
Methods
to
determine
storage
stability,
shelf
life
of
the
micro
organism
Storage
stability
data
are
required
to
ensure
product
performance
and
safety.
The
data
included
in
the
submission
package
were
derived
from
a
single
batch
of
SPORODEX
L
over
a
period
of
11
months
at
20
C.
Additional
storage
stability
data
derived
from
at
least
five
production
scale
or
pilot
scale
batches
are
required
to
support
label
claims
and
ensure
product
performance
and
safety.
An
expiration
date
of
three
months
from
the
date
of
manufacture
is
required
until
additional
data
are
generated.
2.2
Methods
to
determine
and
quantify
residues
(viable
or
non
viable)
of
the
active
micro
organism
and
relevant
metabolites
Although
Pseudozyma
species
are
ubiquitous
in
nature
and
have
been
isolated
from
a
wide
variety
of
plant
surfaces
including,
leaf
litter,
clover,
maize
and
cucumbers,
no
adverse
effects
from
dietary
exposure
have
been
attributed
to
natural
populations
of
P.
flocculosa.
Given
that
there
are
no
significant
adverse
effects
reported
in
acute
oral
toxicity/
pathogenicity
study
and
that
there
are
no
reports
in
literature
suggesting
Pseudozyma
(Sporothrix)
flocculosa
produces
mammalian
toxins,
the
establishment
of
a
maximum
residue
limit
(MRL)
is
not
required
for
Pseudozyma
flocculosa
strain
PF
A22
UL.
Consequently,
no
method(
s)
to
quantify
Pseudozyma
flocculosa
strain
PF
A22
UL
residues
in
food
and
feed
are
required.
Analytical
methods
for
detecting
viable
Pseudozyma
flocculosa
residues
in
animal
and
human
body
tissues
involve
blending
of
tissues
and
recovery
on
yeast
malt
agar
(YM)
or
Martin's
agar
(MA).
If
needed,
a
multiplex
PCR
analysis
(see
Section
2.
1.
1
for
details)
can
be
performed
to
discriminate
strain
PF
A22
UL
from
other
strains
of
P.
flocculosa.
Chapter
3
Impact
on
human
health
and
safety
P.
flocculosa
strain
PF
A22
UL
was
considered
of
low
toxicity
and
no
pathogenicity
based
on
the
results
of
the
Tier
I
toxicology
studies.
Tier
II
and
Tier
III
studies
were
not
required
because
the
results
from
the
Tier
I
studies
were
sufficient
to
satisfy
guideline
requirements.
On
the
basis
of
the
studies
submitted,
it
was
considered
a
Toxicity
Category
III
pesticide
for
acute
oral
effects
due
to
the
amount
dosed
only,
and
Toxicity
Category
IV
for
dermal
and
primary
dermal
irritation
health
effects.
These
and
additional
toxicology
studies
are
summarized
below.
Product
Monograph
Pseudozyma
flocculosa
strain
PF
A22
UL
13
3.1
Toxicity
and
infectivity
summaries
(Tier
I
acute
studies)
3.1.1
Acute
oral
toxicity
/
pathogenicity
study
(OPPTS
885.3050)
(MRID#
s
451152
04
453634
01)
No
signs
of
toxicity
or
pathogenicity
were
noted
when
SPORODEX
WP,
a
wettable
powder
formulation,
was
administered
to
rats
via
the
oral
route.
In
an
acute
oral
toxicity
study,
groups
of
fasted
6
7
week
old
Fisher
344
rats
(12/
sex)
were
administered
a
single
oral
dose
of
SPORODEX
WP
in
USP
sterile
water
for
injection
at
doses
of
5.8
x
10
8
colony
forming
units
(CFU)
per
animal
for
males
and
5.
6
x
10
8
CFU
per
animal
for
females.
An
equal
number
of
animals
were
dosed
with
heat
killed
test
substance
and
four
animals/
sex
served
as
untreated
controls.
The
animals
were
then
observed
for
a
period
of
up
to
21
days
with
interim
scheduled
sacrifices.
No
effect
on
body
weight
gain
and
no
apparent
signs
of
treatment
related
toxicity,
infectivity
or
pathogenicity
were
observed
in
any
of
the
treated
animals
during
the
study
period.
Clearance
of
the
test
organism
occurred
by,
or
prior
to,
posttreatment
day
7.
Based
on
the
results
of
this
study,
SPORODEX
L
and
its
active
ingredient,
P.
flocculosa,
is
not
considered
toxic
or
pathogenic
to
male
or
female
Fisher
344
rats.
The
test
substance
used
in
this
study
was
a
wettable
powder
formulation
of
SPORODEX.
A
change
in
the
intended
formulation
of
the
end
use
products
from
a
wettable
powder
to
a
liquid
formulation
(SPORODEX
L),
however,
triggered
the
need
for
a
rationale
for
the
test
substance.
The
applicant
requested
a
waiver
from
submitting
a
replacement
acute
oral
study
using
the
TGAI
or
the
liquid
formulation
based
on
the
fact
that
the
new
formulants
found
in
SPORODEX
L
are
of
food
grade
quality
and
that
the
levels
of
other
formulants
have
been
significantly
reduced.
The
toxicity
of
the
liquid
formulation
is,
therefore,
expected
to
be
less
than
that
of
the
wettable
powder
formulation
that
was
tested.
3.1.2
Acute
pulmonary
toxicity
/
pathogenicity
study
(OPPTS
885.3150)
(MRID#
s
451152
06,
453634
01)
The
potential
toxicity
and
pathogenicity
of
P.
flocculosa
was
tested
by
observing
the
effects
following
a
single
intratracheal
instillation
of
3.
2
x
10
7
CFU
of
the
test
organism
(TS)
to
each
of
12
male
and
12
female
CD
rats.
An
equal
number
of
animals
were
treated
with
heat
killed
test
substance
(KTS)
and
four
animals/
sex
served
as
untreated
controls.
Animals
were
observed
for
up
to
14
days
with
interim
scheduled
sacrifices.
A
total
of
15
rats
(3/
8
male
and
2/
8
female
TS
dosed
rats
and
6/
8
male
and
4/
8
female
KTSdosed
rats)
died
on
days
2
and
3.
Laboured
respiration,
rough
hair
coat,
ocular
discharge
and
nasal
discharge
were
observed
in
both
TS
and
KTS
dosed
rats.
Hunched
posture
and
lethargy
were
also
observed
in
one
female
and
one
male
TS
dosed
rat,
respectively.
The
presence
or
absence
of
clinical
symptoms
were
not
indicative
of
spontaneous
deaths.
Product
Monograph
Pseudozyma
flocculosa
strain
PF
A22
UL
14
Due
to
the
large
number
of
spontaneous
deaths
and
a
number
of
missed
data
collections,
data
for
evaluating
effects
on
body
weights,
food
consumption
and
relative
organ
weight
were
limited.
At
the
end
of
the
14
day
long
study,
administration
of
P.
flocculosa
did
not
have
a
statistically
significant
effect
on
body
weight.
Analyses
of
daily
food
consumption
and
relative
organ
weights
were
skewed
as
they
were
either
not
determined
or
did
not
include
animals
that
died
prior
to
their
scheduled
sacrifice
dates.
At
necropsy,
liver
lesions
and
lesions
and
enlargement
of
the
lung
and
spleen
were
observed
in
both
TS
and
KTS
dosed
rats.
Confluent
dark
areas
were
also
seen
in
the
kidneys
of
a
single
male
TS
dosed
rat.
These
necropsy
findings
were
considered
consistent
with
the
method
of
dosing
and
the
body's
normal
immunological
response
to
a
foreign
substance.
Pseudozyma
flocculosa
was
detected
in
the
lungs
and
lymph
nodes
and
the
stomach
and
small
intestine
of
TS
dosed
animals
only.
Counts
in
these
tissues
were
below
the
limit
of
detection
by
day
7.
Based
on
this
study,
P.
flocculosa
is
toxic,
but
not
infective
or
pathogenic,
at
the
dose
administered
when
introduced
by
the
intratracheal
route
to
male
and
female
CD
rats.
This
acute
pulmonary
study,
however,
was
originally
classified
as
unacceptable
due
to
major
deficiencies
in
the
collected
toxicity
data
and
a
possible
dosing
error,
as
indicated
by
the
presence
of
the
MPCA
in
the
stomach
and
small
intestines
on
the
day
of
dosing.
However,
there
was
relevant
pathogenicity
information
that
indicated
clearance
of
the
MCPA.
Thus,
this
study
is
considered
to
be
supplemental
because
it
provides
acceptable
information
regarding
infectivity/
pathogenicity;
however,
this
study
does
not
differentiate
the
cause
of
certain
mortalities
in
the
TS
and
KTS
treatments.
A
confirmatory
acute
pulmonary
toxicity
/
pathogenicity
study
using
the
TGAI
and
testing
of
the
sterile
filtrate
from
the
production
culture
will
therefore
be
required
to
provide
this
additional
information
as
a
condition
of
registration.
3.1.3
Acute
pulmonary
range
finding
study
(OPPTS
885.3150)
(MRID#
s
451152
07,
453634
01)
In
order
to
determine
whether
the
test
substance
(in
both
its
viable
and
non
viable
forms),
P.
flocculosa,
was
the
cause
of
the
deaths,
a
subsequent
acute
pulmonary
range
finding
toxicity
study
was
conducted.
In
this
range
finding
study,
groups
of
young
adult
CD
rats
(5/
sex/
dose
level)
were
exposed
by
the
intratracheal
route
to
P.
flocculosa
(4.
2
x
10
7
CFU/
mL)
in
ASTM
Type
1
water
at
doses
of
4.
2
x
10
7
,3.
4x10
7
,6.
8x10
6
and
3.
4
x
10
6
CFU/
animal.
Animals
were
then
observed
for
14
days.
There
were
no
mortalities
and
all
animals
gained
weight
during
the
study.
Rough
hair
coat
occurred
in
a
dose
dependent
manner
with
all
5
animals/
sex
exhibiting
this
symptom
at
the
highest
dose
of
4.
2
x
10
7
CFU/
animal.
One
female
dosed
with
4.2
x
10
7
CFU
experienced
tremors,
closed
eyes
and
rough
hair
coat.
Pseudozyma
flocculosa
was
classified
as
being
of
slight
toxicity
(EPA
Toxicity
Category
IV)
based
on
adverse
effects
observed
in
some
test
animals.
This
acute
pulmonary
study
was
considered
supplemental.
According
to
USEPA
OPPTS
Product
Monograph
Pseudozyma
flocculosa
strain
PF
A22
UL
15
885.3150,
the
minimum
dose
is
10
8
units
of
the
MPCA
per
test
animal.
The
maximum
dose
level
used
in
this
study,
however,
was
only
4.2
x
10
7
CFU/
animal.
The
maximum
dose
level
used
in
this
study,
however,
was
only
4.2
x
10
7
CFU/
animal.
Furthermore,
infectivity
was
not
addressed;
however,
the
acute
pulmonary
toxicity/
pathogenicity
study
did
address
infectivity
sufficiently.
Consequently,
this
study
does
not
satisfy
the
guideline
requirement
for
an
acute
pulmonary
study
(OPPTS
885.3150)
in
the
rat.
EPA,
in
considering
the
two
studies
together,
believes
that
there
are
sufficient
data
with
which
to
determine
the
toxicity
and
pathogenicity
of
Pseudozyma
flocculosa.
As
any
potential
inhalation
risk
that
is
raised
by
these
studies
is
primarily
a
worker
risk,
EPA
is
requiring
that
a
respirator
be
worn
by
workers
to
limit
any
inhalation
exposures.
In
addition,
a
Restricted
Entry
Interval
(REI)
of
4
hours
is
required
for
early
entry
postapplication
workers
or
other
persons
entering
treated
greenhouses.
Finally,
a
confirmatory
acute
pulmonary
toxicity
/
pathogenicity
study
using
the
TGAI
and
testing
of
the
sterile
filtrate
from
the
production
culture
will
be
required
as
a
condition
of
registration.
3.1.4
Intraperitoneal
toxicity
/
infectivity
study
(OPPTS
885.3200)
(MRID#
s
451152
08,
453634
01)
In
an
acute
intraperitoneal
toxicity/
infectivity
study,
groups
of
young
adult
CD
rats
(4/
sex/
scheduled
sacrifice
date)
were
exposed
by
the
intraperitoneal
route
to
an
undiluted
suspension
of
P.
flocculosa
(TS)
ata
dose
of3.
5x10
7
CFU/
animal
(in
1.
0
mL).
Animals
were
then
observed
for
up
to
14
days.
An
equal
number
of
young
adult
CD
rats
were
similarly
injected
with
heat
killed
test
substance
(KTS).
An
undosed
naive
control
(NC)
group
consisting
of
4
rats/
sex
was
also
included
in
the
study.
Cage
side
observation
for
clinical
symptoms
was
performed
daily
and
animal
body
weights
and
food
consumption
were
monitored.
No
unscheduled
deaths
occurred.
Designated
animals
from
the
TS
and
KTS
groups
were
sacrificed
on
days
0,
7
and
14
and
gross
necropsies
were
performed.
The
NC
group
of
animals
was
sacrificed
and
necropsied
at
the
end
of
the
14
day
study.
Infectivity
and
clearance
were
assessed
by
quantitatively
recovering
the
MPCA
from
the
blood,
lungs
and
lymph
nodes,
spleen,
kidneys,
liver,
heart,
stomach
and
small
intestine,
peritoneal
fluid,
caecum
and
brain.
No
adverse
clinical
signs
were
observed
at
any
point
of
the
study
in
any
of
the
groups
of
rats.
Body
weight
gain
of
TS
dosed
male
rats
was
significantly
decreased
while
this
group's
food
consumption
was
significantly
increased
compared
to
NC
animals.
There
was
no
significant
difference
between
KTS
dosed
and
NC
animals
in
terms
of
body
weight,
body
weight
gain
or
food
consumption.
Upon
necropsy
of
TS
and
KTS
dosed
animals,
white
nodules
and
higher
relative
spleen
weights
were
observed
and
attributed
to
a
normal
immune
response
to
a
foreign
substance.
The
detection
of
P.
flocculosa
in
the
peritoneal
fluid
lavage
of
TS
dosed
male
rats
was
consistent
with
the
method
of
administration.
Clearance
of
P.
flocculosa
from
all
other
tissues
and
fluids
occurred
by
day
7.
No
test
substance
was
detected
from
any
of
the
organs
of
the
KTS
dosed
or
NC
animals.
At
the
dose
administered,
P.
flocculosa
was
slightly
toxic
but
not
pathogenic
to
male
and
female
CD
rats
when
introduced
by
the
intraperitoneal
route.
Product
Monograph
Pseudozyma
flocculosa
strain
PF
A22
UL
16
3.1.5
Acute
dermal
toxicity
/
irritation
study
(
OPPTS
885.3100)
(MRID#
s
451152
09,
453634
01)
In
an
acute
dermal
toxicity
study,
a
single
group
of
New
Zealand
White
rabbits
(5/
sex)
was
dermally
exposed
to
1.
2
x
10
7
CFU
P.
flocculosa
(equivalent
to
approximately
0.82
0.90
g/
kg
bw
for
males
and
0.
80
0.91
g/
kg
bw
for
females),
for
24
hours
to
an
area
equivalent
to
approximately
10%
of
the
dorsal
skin
surface.
Following
exposure,
the
animals
were
observed
for
a
period
of
14
days.
No
treatment
related
signs
of
toxicity
or
skin
irritation
were
observed
in
any
animal
during
the
14
day
observation
period.
At
the
dose
administered,
P.
flocculosa
was
not
considered
toxic
or
irritating
to
the
skin.
The
recommended
test
substance
for
acute
dermal
toxicity
and
acute
dermal
irritation
studies
is
the
end
use
product.
Instead,
the
test
substance
was
produced
by
the
test
facility
using
a
method
different
from
the
proposed
manufacturing
method.
An
acceptable
waiver
rationale
was
submitted
to
address
the
toxicity
and/
or
irritation
potential
of
the
formulation
ingredients.
The
waiver
rationale
was
based
on
the
formulation
ingredients
being
of
food
grade
quality
or
considered
as
relatively
non
toxic.
3.1.6
Primary
eye
irritation
study
(OPPTS
870.2400)
(MRID#
s
451152
10,
453634
01)
Administration
of
0.
1
g
of
SPORODEX
WP
to
the
eyes
of
rabbits
resulted
in
slight
conjunctival
redness
in
5/
6
animals
at
the
1
hour
scoring
interval
and
in
2/
6
rabbits
at
the
24
hour
scoring
interval.
By
the
48
hour
scoring
interval,
all
signs
of
ocular
irritation
had
subsided.
There
were
no
other
adverse
clinical
symptoms
or
mortalities
during
the
7
day
observation
period.
The
maximum
irritation
score
(MIS)
was
1.
7
at
the
1
hour
scoring
interval
and
the
maximum
average
score
(MAS)
was
0.
22
over
the
24,
48
and
72
hour
scoring
intervals.
Based
on
the
MAS,
SPORODEX
WP
was
classified
as
minimally
irritating.
The
test
substance
used
in
this
study
was
a
wettable
powder
formulation
containing
a
potential
ocular
irritant.
The
current
formulation,
SPORODEX
L,
contains
a
much
lower
level
of
the
potential
irritant.
Therefore,
SPORODEX
L
is
expected
to
be
less
irritating
to
the
eye
than
SPORODEX
WP.
3.1.7
Subchronic,
chronic
toxicity
and
oncogenicity
Survival,
replication,
infectivity,
significant
toxicity
or
persistence
of
the
MPCA
was
not
observed
in
the
test
animals
treated
in
Tier
I
acute
oral,
pulmonary
and
intravenous
toxicity/
infectivity
tests.
Consequently,
higher
tier
tests
involving
subchronic
and
chronic
Product
Monograph
Pseudozyma
flocculosa
strain
PF
A22
UL
17
testing,
oncogenicity
testing,
mutagenicity
and
teratogenicity
were
not
required
based
on
the
lack
of
concerns
following
analysis
of
Tier
I
test
results.
3.1.8
Effects
on
the
immune
and
endocrine
systems
EPA
does
not
have
any
information
regarding
endocrine
effects
of
this
microbial
pesticide
at
this
time.
There
is
no
evidence
to
suggest
that
use
of
P.
flocculosa
strain
PF
A
22
UL
at
the
proposed
concentrations
will
adversely
affect
the
endocrine
or
immune
systems.
The
active
ingredient,
P.
flocculosa
strain
PF
A22
UL,
is
not
known
to
be
a
human
pathogen
nor
an
endocrine
disrupter.
The
submitted
toxicity/
pathogenicity
studies
in
the
rodent
indicate
that,
following
several
routes
of
exposure,
the
immune
system
is
still
intact
and
able
to
process
and
clear
the
active
ingredient.
Therefore,
no
adverse
effects
to
the
immune
and
endocrine
systems
are
known
or
expected.
Based
on
this
rationale,
the
registrant
waiver
request
for
OPPTS
880.3800
(Immune
Response)
was
found
to
be
acceptable.
Table
3.
1
Summary
of
toxicity
and
pathogenicity
studies
with
Pseudozyma
flocculosa
STUDY
SPECIES/
STRAIN
AND
DOSES
/
TEST
SUBSTANCE
LD50
,
MIS/
MAS
TARGET
ORGAN/
SIGNIFICANT
EFFECTS/
COMMENTS
ACUTE
STUDIES
Oral
(MRID#
s
451152
04,
453634
01)
Rat
Fisher
344,
12/
sex,
5.8
x
10
8
CFU
1
/animal
5.6
x
10
8
CFU/
animal
SPORODEX
WP
LD50
>5.
8×
10
8
CFU/
animal
LD50
>5.
6×
10
8
CFU/
animal
No
effect
on
body
weight
gain
or
feed
consumption
and
no
clinical
signs
of
treatment
related
toxicity,
infectivity
or
pathogenicity.
No
mortalities.
Agent
cleared
from
the
gastrointestinal
tract
within
seven
days
of
dosing
and
was
not
detected
in
the
urine,
blood
or
other
organs
at
any
time.
No
significant
findings
observed
at
necropsy.
LOW
TOXICITY
AND
NO
PATHOGENICITY.
Product
Monograph
Pseudozyma
flocculosa
strain
PF
A22
UL
18
Pulmonary
(MRID#
s
451152
06
453634
01)
Rat
CD,
12/
sex,
3.2
x
10
7
CFU/
animal
Pseudozyma
flocculosa
LD50
>3.
2×
10
7
CFU/
animal
Laboured
breathing,
rough
hair
coat,
ocular
discharge
and
nasal
discharge
observed
in
TS
2
and
KTS
3
dosed
animals.
Hunched
posture
and
lethargy
observed
in
one
TS
dosed
female
and
one
TS
dosed
male,
respectively.
Mortalities
included
3
TS
dosed,
6
KTS
dosed,
2
TSdosed
and
4
KTS
dosed
rats.
No
effect
on
body
weight
based
on
rats
sacrificed
on
day
14.
Daily
food
consumption
analysis
and
relative
organ
weights
either
not
determined
or
did
not
include
animals
that
died
prior
to
their
scheduled
sacrifice
dates.
Necropsy
findings
including
lesions
and
enlargement
of
the
lung,
confluent
dark
areas
in
the
kidneys,
lesions
and
enlargement
of
the
spleen
and
lung
lesions
in
and
rats
dosed
with
TS
and
KTS
were
attributed
to
the
method
of
dosing
and
the
body's
normal
immunological
response
to
a
foreign
substance.
Agent
was
detected
in
the
lungs
and
lymph
nodes,
stomach
and
small
intestines.
Clearance
from
these
organs
by
day
7.
Study
classified
as
SUPPLMENTAL.
This
study
is
considered
to
be
supplemental
because
it
provides
acceptable
information
regarding
infectivity/
pathogenicity;
however,
this
study
does
not
differentiate
the
cause
of
certain
mortalities
in
the
TS
and
KTS
treatments.
Confirmatory
acute
pulmonary
toxicity/
pathogenicity
study
is
required
using
the
TGAI
and
testing
of
the
sterile
filtrate
from
production
batches.
Pulmonary
Range
Finding
(MRID#
451152
07
453634
01)
Rat
CD,
5/
sex/
dose
level
4.2
x
10
7
CFU/
animal
3.4
x
10
7
CFU/
animal
6.8
x
10
6
CFU/
animal
3.4
x
10
6
CFU/
animal
Pseudozyma
flocculosa
LD50
>4.2
x
10
7
CFU/
animal
No
mortalities.
All
animals
gained
weight
over
the
course
of
the
14
day
study.
Rough
haircoatoccurred
in
a
dosedependent
manner.
One
female
rat
dosed
at4.2
x
10
7
CFU
presented
with
tremors,
closed
eyes
and
rough
hair
coat.
SLIGHTLY
TOXIC;
PATHOGENICITY
NOT
DETERMINED.
Study
classified
as
SUPPLEMENTAL.
Upgraded
label
statements
required.
Confirmatory
acute
pulmonary
toxicity/
pathogenicity
study
is
required
using
the
TGAI
and
testing
of
the
sterile
filtrate
from
production
batches.
Product
Monograph
Pseudozyma
flocculosa
strain
PF
A22
UL
19
Intraperitoneal
Injection
(MRID#
s
451152
08
453634
01)
Rat
Sprague
Dawley,
12/
sex,
3.5
x
10
7
CFU/
animal
Pseudozyma
flocculosa
LD50
>3.
5×
10
7
CFU/
animal
No
effect
on
body
weight
but
body
weight
gain
significantly
lower
in
TS
dosed
rats
despite
increased
food
consumption
by
TS
dosed
rats.
No
clinical
symptoms
or
mortalities.
White
nodules
noted
on
stomach,
caecum,
liver
or
small
intestine
of
and
rats
dosed
with
TS
and
KTS
attributed
to
normal
immunological
response
to
a
foreign
substance.
Increased
relative
spleen
weight
in
TS
and
KTSdosed
rats
also
considered
to
be
a
normal
response.
Following
injection,
the
test
microbe
was
recovered
from
the
caecum,
kidneys,
liver,
lungs
and
associated
lymph
nodes,
spleen
and
stomach
and
small
intestines
of
and
TS
dosed
rats.
Clearance
of
the
test
organism
occurred
within
7
days
of
administration.
SLIGHTLY
TOXIC
AND
NO
PATHOGENICITY
Dermal
Toxicity
and
Irritation
(MRID#
s
451152
09,
453634
01)
Rabbit
New
Zealand
White,
5/
sex
1.2
x
10
7
CFU/
animal
Pseudozyma
flocculosa
(equivalent
to
approximately
0.
82
0.90
g/
kg
bw
for
and
0.
80
0.91
g/
kg
bw
for
)
LD50
>1.
2×
10
7
CFU/
animal
(
LD50
>
0.
82
0.90
g/
kg
bw
LD50
>
0.
80
0.91
g/
kg
bw)
No
mortalities.
One
rabbit
lost
weight
within
the
first
week
but
experienced
a
slight
weight
gain
thereafter.
All
other
animals
gained
weight.
Slight
diarrhea
observed
in
one
7
days
after
administration.
No
other
adverse
clinical
symptoms.
No
signs
of
dermal
irritation.
LOW
TOXICITY
AND
NONIRRITATING
Eye
Irritation
(MRID#
s
451152
10,
453634
01)
Rabbit
New
Zealand
White,
6
females,
0.1
g
(equivalent
to
5.7
x
10
7
CFU/
animal)
SPORODEX
WP
MIS
4
=
1.
7
/
110
at
the
onehour
scoring
interval
MAS
5
=0.
22
Slight
conjunctival
redness
observed
in
5/
6
animals
at
the
one
hour
scoring
interval.
By
the
24
hour
scoring
interval,
only
2/
6
animals
continued
to
exhibit
slight
conjunctival
redness.
All
signs
of
ocular
irritation
were
absent
at
the
48
hour
scoring
interval.
No
other
signs
of
ocular
irritation
or
adverse
clinical
symptoms.
No
mortalities.
SPORODEX
WP
formulation
expected
to
be
more
irritating
to
the
eye
than
SPORODEX
L.
MINIMALLY
IRRITATING.
1
CFU
=
Colony
Forming
Units
2
TS
=
Test
Substance
3
KTS
=
Killed
Test
Substance
4
MIS
=
Maximum
Irritation
Score
5
MAS
=
Maximum
Average
Score
(based
on
scores
from
24,
48
and
72
hour
scoring
intervals)
3.1.9
Integrated
toxicity
and
infectivity
summary
The
registration
package
submitted
by
Plant
Products
Co.
in
support
of
registering
the
technical
grade
active
ingredient
(TGAI)
Pseudozyma
flocculosa
strain
PF
A22
UL
and
the
end
use
product
(EP)
SPORODEX
L,
was
reviewed
from
the
viewpoint
of
human
health
and
safety
and
was
determined
to
be
sufficiently
complete
to
permit
a
decision
on
registration.
The
information
provided
to
address
the
characterization
of
the
active
ingredient
as
well
as
the
manufacturing
Product
Monograph
Pseudozyma
flocculosa
strain
PF
A22
UL
20
process
and
quality
control
adequately
addressed
the
potential
human
health
and
safety
concerns
associated
with
P.
flocculosa
strain
PF
A22
UL
and
bacterial/
fungal
contaminants
introduced
during
production.
No
signs
of
toxicity
or
pathogenicity
were
noted
when
SPORODEX
WP,
a
wettable
powder
formulation,
was
administered
to
rats
via
the
oral
route.
Intratracheal
administration
of
P.
flocculosa
resulted
in
a
significant
number
of
spontaneous
deaths
among
both
TS
and
KTS
dosed
animals.
Presence
of
the
test
organism
in
the
stomach
and
small
intestines
indicated
a
potential
dosing
error.
In
a
second
pulmonary
study,
there
were
no
mortalities
but
rough
hair
coat
occurred
in
a
dose
dependent
manner.
Based
on
this
study,
P.
flocculosa
was
classified
as
slightly
toxic.
This
study
was
considered
supplemental
because
infectivity
was
not
assessed
and
because
the
test
substance
was
not
the
recommended
TGAI.
The
label
must
be
upgraded
with
a
statement
requiring
respirators
for
all
users
and
a
complete
acute
pulmonary
toxicity
/
infectivity
study,
using
the
TGAI,
will
be
required.
Pseudozyma
flocculosa
was
found
to
be
slightly
toxic
but
non
pathogenic
when
administered
to
rats
via
intraperitoneal
injection.
There
were
no
mortalities
or
adverse
clinical
symptoms.
White
nodules
and
higher
relative
spleen
weights
were
noted
at
necropsy
and
attributed
to
a
normal
immune
response
to
a
foreign
substance.
Male
TS
dosed
rats,
however,
exhibited
decreased
body
weight
gain
despite
increased
food
consumption
indicating
that
P.
flocculosa
was
slightly
toxic.
Clearance
of
the
test
organism
occurred
within
7
days
indicating
lack
of
pathogenicity.
P.
flocculosa
was
not
toxic
or
irritating
when
applied
dermally
to
rabbits.
A
waiver
rationale
was
submitted
to
address
the
toxicity
and/
or
irritation
potential
of
the
formulation
ingredients
in
SPORODEX
L.
All
formulation
ingredients
are
either
of
food
grade
quality
or
classified
as
relatively
non
toxic.
One
formulation
ingredient
may
cause
irritation
of
the
skin
with
prolonged
contact.
Standard
personal
protective
equipment
requirements
are
adequate.
Slight
conjunctival
redness
was
observed
after
administration
of
SPORODEX
WP
to
the
eyes
of
rabbits.
The
irritation
potential
of
SPORODEX
L
is
expected
to
be
less
than
that
of
SPORODEX
WP.
Standard
label
statements
instructing
users
to
avoid
contact
with
eyes
are
sufficient.
Pseudozyma
flocculosa
has
not
been
reported
to
produce
any
mammalian
toxins.
The
applicant
included
computer
literature
search
results
to
a
number
of
keywords
such
as
pseudozyma*,
tilletiopsis,
fate,
non
target,
carcin*,
mutagen*,
toxic*,
pathogen*,
antibiotic*,
polyen*,
sporothrix,
sporobolomyces,
rhodotorula,
phyllosphere
yeast*,
carcinog*
and
teratogen*.
The
literature
search
covered
AGRICOLA,
Biological
Abstracts,
CAB
Abstracts,
CHEMTOX,
RTEX
and
AGRIS
databases
from
1980
to
1999.
No
reports
of
mammalian
toxicity
were
found
in
standard
biological,
chemical
and
toxicological
abstracts.
Product
Monograph
Pseudozyma
flocculosa
strain
PF
A22
UL
21
3.2
Hypersensitivity
(derminal
sensitization
study
OPPTS
870.2600
and
reports
of
incidents
OPPTS
885.3400)
The
applicant
has
also
submitted
an
acceptable
waiver
rationale
from
conducting
a
dermal
sensitization
study
based
on
the
assumption
that
most
microorganisms
contain
substances
that
could
elicit
a
hypersensitivity
response.
Pseudozyma
flocculosa
is
considered
a
potential
sensitizing
agent,
therefore,
the
statement,
"POTENTIAL
SENSITIZER"
is
required
on
the
principal
display
panels
of
the
technical
and
end
use
formulation
labels.
The
use
of
personal
protective
equipment
will
also
be
required
to
mitigate
against
potential
dermal
sensitization
in
occupationally
exposed
workers/
handlers.
Skin
sensitizing
studies
are
not
considered
substitutes
for
timely
reports
of
hypersensitivity
incidents
subsequent
to
registration
approval.
No
adverse
effects
have
been
noted
among
researchers
who
have
worked
closely
with
P.
flocculosa
strain
PF
A22
UL
for
up
to
10
years.
The
applicant
will
be
expected
to
report
any
subsequent
findings
of
hypersensitivity
or
other
health
incidents
to
workers,
applicators,
or
bystanders
exposed
to
the
MPCA
as
a
condition
of
registration.
Incident
reports
are
to
include
details
such
as
a
description
of
the
MPCA
and
formulation,
frequency,
duration
and
routes
of
exposure
to
the
material,
clinical
observations,
and
any
other
relevant
information.
3.3
Impact
on
human
and
animal
health
arising
from
exposure
to
the
active
substance
or
to
impurities
contained
in
it
3.3.1
Occupational
and
bystander
exposure
assessment
When
handled
according
to
the
label
instructions,
the
pulmonary,
dermal
and
ocular
routes
are
potential
routes
of
applicator
and
bystander
exposure.
Occupational
exposure
is
of
particular
concern
as
the
product
will
be
used
in
an
enclosed
environment.
U.
S.
EPA
and
Canada/
PMRA,
however,
do
not
expect
that
occupational
exposures
will
pose
an
undue
risk
on
the
basis
of
the
low
toxicity/
pathogenicity
profile.
While
submitted
acute
pulmonary
toxicity/
infectivity
studies
were
found
to
be
lacking,
inhalation
exposure
is
not
of
concern
if
the
required
respirator
is
worn
by
workers.
To
mitigate
dermal
and
inhalation
exposure
and
risk
to
workers,
use
of
appropriate
Personal
Protective
Equipment
(PPE)
will
be
required.
Furthermore
a
Restricted
Entry
Interval
(REI)
of
4
hours
is
required
for
early
entry
(post
application)
workers
or
other
persons
entering
treated
greenhouses.
Assuming
that
most
microorganisms
contain
substances
that
would
elicit
positive
hypersensitivity
reactions,
P.
flocculosa
strain
PF
A22
UL
is
considered
a
potential
sensitizing
agent,
and
a
"POTENTIAL
SENSITIZER"
statement
will
be
required
on
the
principal
display
panel
of
the
TGAI
and
end
use
formulation
labels.
The
label
does
not
allow
applications
to
turf,
residential
or
recreational
areas.
Because
the
use
sites
are
in
greenhouses,
exposure
to
infants
and
children
in
school,
residential
and
daycare
Product
Monograph
Pseudozyma
flocculosa
strain
PF
A22
UL
22
facilities
is
likely
to
be
minimal
to
non
existent.
Consequently,
the
health
risk
to
infants
and
children
is
expected
to
be
negligible
to
non
existent.
Chapter
4
Residues
In
examining
aggregate
exposure,
FFDCA
section
408
directs
U.
S.
EPA
to
consider
available
information
concerning
exposures
from
the
pesticide
residue
in
food
and
all
other
nonoccupational
exposures,
including
drinking
water
from
ground
water
or
surface
water
and
exposure
through
pesticide
use
in
gardens,
lawns,
or
buildings
(residential
and
other
indoor
uses).
Based
on
the
data
and
analyses
outlined
above,
U.
S.
EPA
has
concluded
that
there
is
a
reasonable
certainty
that
no
harm
will
result
from
aggregate
exposure
to
the
U.
S.
population,
including
infants
and
children,
to
residues
of
P.
flocculosa
strain
PF
A22
UL
arising
from
use
on
greenhouse
grown
cucumbers
and
roses.
This
includes
all
anticipated
dietary
exposures
and
all
other
exposures
for
which
there
is
reliable
information.
4.1
Residues
relevant
to
consumer
safety
4.
1.
1
Dietary
exposure
and
risk
assessment
The
proposed
food
use
pattern
is
likely
to
result
in
residues
in
or
on
food
and
feed.
Residues
of
the
microbial
pesticide
are
likely
to
be
removed
from
treated
food
by
washing,
peeling,
cooking
and
processing.
Even
if
residues
are
not
removed,
however,
EPA
believes
that
dietary
exposure
to
the
microbial
agent
will
result
in
negligible
to
no
risk
to
consumers.
Although
Pseudozyma
species
are
ubiquitous
in
nature
and
have
been
isolated
from
a
wide
variety
of
plant
surfaces
including
leaf
litter,
clover,
maize
and
cucumber,
no
adverse
effects
from
dietary
exposure
have
been
attributed
to
natural
populations
of
Pseudozyma
flocculosa.
Furthermore,
no
adverse
effects
were
observed
at
maximum
hazard
dose
levels
in
the
acute
oral
toxicity
/
pathogenicity
study
and
there
are
no
reports
of
known
mammalian
toxins
being
produced
by
the
MPCA.
Subchronic
and
chronic
dietary
exposure
studies
were
not
required
because
the
Tier
I
acute
oral
study
demonstrated
a
low
level
of
toxicity
and
no
pathogenicity
potential
for
the
active
microorganism.
Because
of
the
low
toxicity
profile
and
low
potential
exposure
of
the
MPCA
expected
for
the
proposed
uses,
there
is
no
concern
for
chronic
risks
posed
by
dietary
exposure
for
the
general
population
or
sensitive
subpopulations,
such
as
infants
and
children.
In
addition,
an
extensive
literature
search
yielded
no
reports
of
mammalian
toxins
being
produced
by
P.
flocculosa
(see
section
3.
1.
9).
The
fungitoxic
unsaturated
C
17
fatty
acids
and
acyclic
norterpene
produced
by
the
MPCA
have
not
been
reported
to
be
toxic
to
mammals.
Neither
this
organism
nor
its
close
relatives
are
listed
among
microbial
contaminants
of
food.
Therefore,
EPA
expects
negligible
to
no
dietary
risk
from
exposure
to
naturally
occurring
and
isolated
P.
flocculosa
strain
PF
A22
UL
residues.
4.1.2
Drinking
water
exposure
and
risk
assessment
Product
Monograph
Pseudozyma
flocculosa
strain
PF
A22
UL
23
Although
heavy
rainfall
likely
carries
P.
flocculosa
into
neighboring
aquatic
environments,
growth
and
survival
of
terrestrial
fungi
such
as
P.
flocculosa
is
limited
in
such
environments.
Thus,
it
is
not
expected
to
proliferate
in
aquatic
habitats
following
incidents
of
direct
or
indirect
exposure
(e.
g.,
runoff
from
treated
greenhouses).
Moreover,
P.
flocculosa
is
not
considered
to
be
a
risk
to
drinking
water
because
of
minimal
to
non
existent
toxicity.
Accordingly,
drinking
water
is
not
specifically
screened
for
P.
flocculosa
as
a
potential
indicator
of
microbial
contamination
or
as
a
direct
pathogenic
contaminant.
Both
percolation
through
soil
and
municipal
treatment
of
drinking
water
would
reduce
the
possibility
of
significant
transfer
of
residues
to
drinking
water.
Therefore,
the
potential
of
exposure
and
risk
to
humans
via
drinking
water
is
likely
to
be
minimal
to
non
existent
for
this
MPCA.
4.1.3
Maximum
residue
limits
Although
Pseudozyma
species
are
ubiquitous
in
nature
and
have
been
isolated
from
a
wide
variety
of
plant
surfaces
including
leaf
litter,
clover,
maize
and
cucumber,
no
adverse
effects
from
dietary
exposure
have
been
attributed
to
natural
populations
of
Pseudozyma
flocculosa.
Furthermore,
no
adverse
effects
were
observed
in
the
acute
oral
toxicity
/
pathogenicity
study
and
there
are
no
reports
of
known
mammalian
toxins
being
produced
by
the
MPCA.
Therefore,
the
establishment
of
a
tolerance
or
maximum
allowable
residue
limit
is
not
required
for
P.
flocculosa
strain
PF
A22
UL
under
Section
408
of
the
Federal
Food
Drug
and
Cosmetic
Act.
4.2
Aggregate
exposure
from
multiple
routes
including
oral,
dermal,
and
inhalation
The
current
label
does
not
allow
applications
to
turf,
residential
or
recreational
areas.
Because
the
use
sites
are
in
greenhouses,
exposure
to
the
U.
S.
population
including
infants
and
children
in
school,
residential
and
daycare
facilities
is
likely
to
be
minimal
to
non
existent.
Consequently,
the
health
risk
posed
by
P.
flocculosa
strain
PF
A
22
UL
from
non
occupational
dermal
and
inhalation
exposures
to
the
general
public,
including
infants
and
children,
is
expected
to
be
negligible
to
non
existent.
Any
concerns
for
potential
inhalation
risk
is
for
occupational
exposures,
and
as
mentioned
previously,
will
be
mitigated
by
the
requirement
of
a
respirator
and
restriction
of
the
reentry
interval.
4.2.1
Oral
Oral
exposure
would
occur
primarily
from
eating
treated
foods
and
from
drinking
water.
Residues
of
the
active
microorganism
can
be
easily
removed
from
treated
commodities
by
washing,
cooking,
peeling
and
processing.
Transfer
of
the
active
microogranism
to
drinking
water
is
not
likely
as
discussed
previously.
Thus
dietary
exposure
and
risk
are
likely
to
be
minimal
to
non
existent.
Product
Monograph
Pseudozyma
flocculosa
strain
PF
A22
UL
24
4.2.2
Dermal
Non
occupational
dermal
exposure
and
risk
to
adults,
infants
and
children
are
not
likely
if
the
pesticide
is
used
as
labeled.
The
label
does
not
allow
applications
to
turf,
residential
or
recreational
areas.
The
only
use
sites
are
for
greenhouse
grown
cucumbers
and
roses.
Dermal
exposure
via
the
skin
would
be
the
primary
route
of
exposure
for
applicators.
Since
unbroken
skin
is
a
natural
barrier
to
microbial
invasion
of
the
human
body,
dermal
absorption
could
occur
only
if
the
skin
were
cut,
if
the
microbe
were
a
pathogen
equipped
with
mechanisms
for
entry
through
or
infection
of
the
skin,
or
if
metabolites
were
produced
that
could
be
dermally
absorbed.
P.
flocculosa
is
not
known
to
be
a
human
pathogen
nor
is
it
known
to
produce
metabolites
that
are
dermally
absorbed.
Based
on
the
minimal
adverse
effects
in
the
intraperitoneal
study,
it
is
PMRA's
and
EPA's
opinion
that
even
cut
skin
should
not
pose
a
significant
risk
to
health
via
entry
of
absorbed
P.
flocculosa
into
the
body.
Although
the
MPCA
has
been
found
to
be
non
toxic
and
non
irritating
following
dermal
exposure,
it
is
a
potential
sensitizer.
Label
restrictions
and
risk
mitigation
measures
are
required
to
protect
populations
who
are
likely
to
be
primarily
exposed
to
the
pesticide.
Such
exposure
to
pesticide
handlers
can
be
ameliorated
if
they
wear
long
sleeved
shirts,
long
pants,
shoes
and
socks.
4.2.3
Inhalation
Inhalation
would
be
another
route
of
exposure
for
mixer/
loader
applicators
and
possibly
earlyentry
workers.
Based
on
the
results
of
the
pulmonary
study
in
which
lesions
were
noted
on
the
lungs
of
some
treated
animals,
pesticide
handlers
must
wear
a
dust/
mist
filtering
respirator
with
the
NIOSH
prefix
N
95,
R
95,
P
95
or
HE
filter
for
biological
products.
4.3
Cumulative
effects
The
Agency
has
considered
available
information
on
the
cumulative
effects
of
such
residues
and
other
substances
that
have
a
common
mechanism
of
toxicity.
These
considerations
included
the
cumulative
effects
on
infants
and
children
of
such
residues
and
other
substances
with
a
common
mechanism
of
toxicity.
EPA
is
not
aware
of
any
other
bacteria
or
other
substances,
besides
naturally
occurring
strains
of
Pseudozyma,
that
share
a
common
mechanism
of
toxicity
with
this
active
ingredient.
Given
the
low
toxicity
and
pathogenicity
profile
of
P.
flocculosa,
even
if
there
were
any
other
substances
with
which
P.
flocculosa
shared
a
common
mechanism
of
toxicity,
no
adverse
cumulative
effects
are
expected.
4.4
Determination
of
safety
for
U.
S.
population,
infants
and
children
Based
on
the
toxicology
data
submitted
and
other
relevant
information
in
the
Agency's
files,
there
is
reasonable
certainty
no
harm
will
result
from
aggregate
exposure
of
residues
of
Pseudozyma
flocculosa
strain
PF
A22
UL
to
the
U.
S.
population,
including
infants
and
children,
under
reasonably
foreseeable
circumstances
when
the
microbial
pesticide
product
is
used
as
Product
Monograph
Pseudozyma
flocculosa
strain
PF
A22
UL
25
labeled.
This
includes
all
anticipated
dietary
exposures
and
all
other
exposures
for
which
there
is
reliable
information.
The
Agency
has
arrived
at
this
conclusion
based
on
data
submitted
demonstrating
low
toxicity
at
the
maximum
doses
tested
and
a
lack
of
information
showing
adverse
effects
from
exposure
to
naturally
occurring
P.
flocculosa
as
well
as
a
consideration
of
the
product
as
currently
registered
and
labeled.
As
a
result,
EPA
establishes
an
exemption
from
tolerance
requirements
pursuant
to
FFDCA
408(
c)
and
(d)
for
residues
of
Pseudozyma
flocculosa
strain
PF
A22
UL
in
or
on
all
food
commodities.
FFDCA
section
408
provides
that
EPA
shall
apply
an
additional
tenfold
margin
of
exposure
(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
unless
EPA
determines
that
a
different
margin
of
exposure
(safety)
will
be
safe
for
infants
and
children.
Margins
of
exposure
(safety)
are
often
referred
to
as
uncertainty
(safety)
factors.
In
this
instance,
based
on
all
the
available
information,
the
Agency
concludes
that
P.
flocculosa
strain
PF
A22
UL
is
practically
non
toxic
to
mammals,
including
infants
and
children.
Thus,
there
are
no
threshold
effects
of
concern
and,
as
a
result
the
provision
requiring
an
additional
margin
of
safety
does
not
apply.
Further,
the
provisions
of
consumption
patterns,
special
susceptibility,
and
cumulative
effects
do
not
apply.
As
a
result,
EPA
has
not
used
a
margin
of
exposure
(safety)
approach
to
assess
the
safety
of
P.
flocculosa
strain
PF
A22
UL.
Chapter
5
Fate
and
behavior
in
the
environment
Environmental
fate
data
(Tier
II)
were
not
triggered
as
adverse
effects
on
non
target
organisms
are
not
expected
from
the
proposed
greenhouse
use
of
P.
flocculosa
strain
PF
A22UL.
Environmental
fate
data
waiver
requestsby
Plant
Products
Co.
Ltd.
were
found
to
be
acceptable
(MRID#
451152
11).
Chapter
6
Effects
on
non
target
species
6.1
Birds
6.1.1
Avian
oral
6.1.2
Avian
pulmonary/
inhalation/
injection
(OPPTS
885.4050
and
OPPTS
885.4100,
MRID#
451152
12)
Plant
Products
Co.
Ltd.
submitted
an
acceptable
justification
for
a
data
waiver
from
avian
oral
toxicity
studies
and
avian
pulmonary/
inhalation/
injection
studies.
The
waiver
request
was
based
on
the
rationale
that
P.
flocculosa
is
a
naturally
occurring
soil
microorganism
whose
level
in
the
environment
will
not
significantly
increase
with
greenhouse
use
of
SPORODEX
L
and
that
an
extensive
literature
search
yielded
no
reports
of
adverse
effects
in
birds.
Use
of
SPORODEX
L
in
commercial
greenhouses
is
not
expected
to
result
in
increased
exposure
Product
Monograph
Pseudozyma
flocculosa
strain
PF
A22
UL
26
or
adverse
effects
in
birds.
Birds
will
not
be
directly
exposed
to
the
product
at
the
time
of
application.
Greenhouse
practices
designed
to
limit
exposure
to
the
outside
environment
will
limit
post
application
exposure
to
birds.
Furthermore,
while
the
body
temperature
of
duck
and
quail
species
is
approximately
40
C,
Pseudozyma
species
do
not
grow
at
temperatures
beyond
37
C.
Consequently,
testing
is
considered
unnecessary
to
assess
the
risks
of
SPORODEX
L
to
avian
wildlife.
6.2
Wild
mammals
(OPPTS
885.4150,
MRID#
451152
12)
Plant
Products
Co.
Ltd.
submitted
an
acceptable
justification
for
a
data
waiver
from
wild
mammal
studies.
The
waiver
request
was
based
on
the
rationale
that
P.
flocculosa
is
a
naturallyoccurring
soil
microorganism
whose
level
in
the
environment
will
not
significantly
increase
with
greenhouse
use
of
SPORODEX
L
and
that
an
extensive
literature
search
and
the
studies
submitted
to
address
human
health
issues
yielded
no
reports
or
evidence
of
significant
adverse
effects
in
wild
mammals.
Use
of
SPORODEX
L
in
commercial
greenhouses
are
not
expected
to
result
in
increased
exposure
or
adverse
effects
in
wild
mammals.
Wild
mammals
will
not
be
directly
exposed
to
the
product
at
the
time
of
application.
Greenhouse
practices
designed
to
limit
exposure
to
the
outside
environment
will
limit
post
application
exposure
to
wild
mammals.
Consequently,
testing
is
considered
unnecessary
to
assess
the
risks
of
SPORODEX
L
to
wild
mammals.
6.3
Fish
6.3.1
Freshwater
fish
and
Estuarine/
Marine
animals
(OPPTS
885.4200
and
OPPTS
885.4280,
MRID#
451152
12)
Plant
Products
Co.
Ltd.
submitted
an
acceptable
justification
for
a
data
waiver
from
freshwater
fish
and
estuarine/
marine
aniimal
studies.
The
waiver
request
was
based
on
the
rationale
that
P.
flocculosa
is
a
naturally
occurring
microorganism
whose
level
in
the
environment
will
not
significantly
increase
with
greenhouse
use
of
SPORODEX
L
and
that
an
extensive
literature
search
yielded
no
reports
of
adverse
effects
in
freshwater
fish
and
estuarine/
marine
animals.
Use
of
SPORODEX
L
in
commercial
greenhouses
is
not
expected
to
result
in
increased
exposure
or
adverse
effects
in
freshwater
fish
and
estuarine/
marine
animals.
Consequently,
testing
is
considered
unnecessary
to
assess
the
risks
of
SPORODEX
L
to
freshwater
fish
and
estuarine/
marine
animals.
Product
Monograph
Pseudozyma
flocculosa
strain
PF
A22
UL
27
6.4
Arthropods
6.4.1
Terrestrial
arthropods
(OPPTS
885.4340
and
885.4380,
MRID#
451152
12)
Plant
Products
Co.
Ltd.
submitted
an
acceptable
justification
for
a
data
waiver
from
terrestrial
arthropod
and
honey
bee
testing.
The
waiver
request
was
based
on
the
rationale
that
P.
flocculosa
is
a
naturally
occurring
microorganism
whose
level
in
the
environment
will
not
significantly
increase
with
greenhouse
use
of
SPORODEX
L
and
that
an
extensive
literature
search
yielded
no
reports
of
adverse
effects
in
terrestrial
arthropods.
Terrestrial
arthropods,
outside
of
greenhouse
facilities
using
SPORODEX
L,
will
not
be
directly
exposed
to
the
product
at
the
time
of
application.
Greenhouse
practices
designed
to
limit
exposure
to
the
outside
environment
will
limit
post
application
exposure
to
terrestrial
arthropods.
Use
of
SPORODEX
L
in
commercial
greenhouses
is
not
expected
to
result
in
increased
exposure
or
adverse
effects
in
terrestrial
arthropods
and
honeybees.
Consequently,
testing
is
considered
unnecessary
to
assess
the
risks
of
SPORODEX
L
to
terrestrial
arthropods
and
honey
bees.
6.4.2
Aquatic
arthropods
(OPPTS
885.4240,
MRID#
451152.12)
Plant
Products
Co.
Ltd.
submitted
an
acceptable
justification
for
a
data
waiver
from
aquatic
arthropod
studies.
The
waiver
request
was
based
on
the
rationale
that
P.
flocculosa
is
a
naturally
occurring
microorganism
whose
level
in
the
environment
will
not
significantly
increase
with
greenhouse
use
of
SPORODEX
L
and
that
an
extensive
literature
search
yielded
no
reports
of
adverse
effects
in
aquatic
arthropods.
Use
of
SPORODEX
L
in
commercial
greenhouses
is
not
expected
to
result
in
increased
exposure
or
adverse
effects
in
aquatic
arthropods.
Consequently,
testing
is
considered
unnecessary
to
assess
the
risks
of
SPORODEX
L
to
aquatic
arthropods.
6.5
Non
arthropod
invertebrates
(OPPTS
885.4240
and
885.4340,
MRID#
451152
12)
Plant
Products
Co.
Ltd.
submitted
an
acceptable
justification
for
a
data
waiver
from
nonarthropod
invertebrate
studies.
The
waiver
request
was
based
on
the
rationale
that
P.
flocculosa
is
a
naturally
occurring
microorganism
whose
level
in
the
environment
will
not
significantly
increase
with
greenhouse
use
of
SPORODEX
L
and
that
an
extensive
literature
search
yielded
no
reports
of
adverse
effects
in
non
arthropod
invertebrates.
Greenhouse
practices
designed
to
limit
exposure
to
the
outside
environment
will
limit
postapplication
exposure
to
non
arthropod
invertebrates.
Use
of
SPORODEX
L
in
commercial
greenhouses
is
not
expected
to
result
in
increased
exposure
or
adverse
effects
in
non
arthropod
invertebrates.
Consequently,
testing
is
considered
unnecessary
to
assess
the
risks
of
SPORODEX
L
to
non
arthropod
invertebrates.
6.6
Microorganisms
(OPPTS
885.1100,
MRID#
451152
12)
Product
Monograph
Pseudozyma
flocculosa
strain
PF
A22
UL
28
In
place
of
submitting
microorganism
studies,
Plant
Products
Co.
Ltd.
submitted
a
summary
of
the
host
range
and
mode
of
action
for
P.
flocculosa.
This
information
has
been
reviewed
for
Part
M2,
Product
Characterization
and
Analysis.
The
applicant
has
also
based
a
waiver
rationale
on
the
natural
occurrence
and
limited
additional
exposure
which
will
be
expected
due
to
the
proposed
uses
of
SPORODEX
L.
A
potential
exists,
particularly
in
a
greenhouse
environment
where
conditions
are
optimal
for
growth
(e.
g.,
high
relative
humidity,
controlled
temperatures),
for
P.
flocculosa
to
adversely
affect
non
target
microorganisms.
Based
on
the
natural
occurrence,
mode
of
action
and
limited
host
range
of
P.
flocculosa,
however,
non
target
microorganism
testing
with
SPORODEX
L
will
not
be
required
to
assess
the
magnitude
of
this
impact.
6.7
Plants
(OPPTS
885.4300,
MRID#
451152
12)
6.7.1
Aquatic
plants
Plant
Products
Co.
Ltd.
submitted
an
acceptable
justification
for
a
data
waiver
from
aquatic
plant
testing.
The
waiver
request
was
based
on
observations
of
no
adverse
effects
in
greenhouse
trials
on
target
crops,
the
natural
occurrence
of
P.
flocculosa,
the
proposed
use
pattern
and
an
extensive
literature
search
which
yielded
no
reports
of
adverse
effects
in
aquatic
plants.
Use
of
SPORODEX
L
in
commercial
greenhouses
is
not
expected
to
result
in
increased
exposure
or
adverse
effects
in
aquatic
plants.
Adequate
containment
measures,
aimed
at
minimizing
exposure
to
the
outside
environment,
are
in
place.
Consequently,
testing
is
considered
unnecessary
to
assess
the
risks
of
SPORODEX
L
to
aquatic
plants.
6.7.2
Terrestrial
plants
Plant
Products
Co.
Ltd.
submitted
an
acceptable
justification
for
a
data
waiver
from
terrestrial
plant
studies.
The
waiver
request
was
based
on
observations
of
no
adverse
effects
in
greenhouse
trials,
the
natural
occurrence
of
P.
flocculosa,
the
proposed
use
pattern
and
an
extensive
literature
search
which
yielded
no
reports
of
adverse
effects
in
terrestrial
plants.
Despite
the
common
occurrence
of
P.
flocculosa,
no
incidents
of
adverse
effects
on
terrestrial
plants
have
been
noted.
The
strain
of
P.
flocculosa
used
in
SPORODEX
L
was,
in
fact,
isolated
from
the
leaves
of
red
clover
grown
in
Harrow,
Ontario.
Furthermore,
visual
inspections
of
cucumber,
rose
and
tomato
plants,
treated
with
P.
flocculosa
for
numerous
efficacy
trials,
yielded
no
signs
of
phytotoxicity.
SPORODEX
L
will
be
used
in
commercial
greenhouses
only.
Non
target
terrestrial
plants
will
not
be
directly
exposed
to
the
product
at
the
time
of
application.
Greenhouse
practices
designed
to
limit
exposure
to
the
outside
environment
will
limit
post
application
exposure
to
non
target
terrestrial
plants.
Use
of
SPORODEX
L
in
commercial
greenhouses
is
not
expected
to
result
in
increased
exposure
or
adverse
effects
in
terrestrial
plants.
Consequently,
testing
is
considered
unnecessary
to
assess
the
risks
of
SPORODEX
L
to
non
target
terrestrial
plants.
Product
Monograph
Pseudozyma
flocculosa
strain
PF
A22
UL
29
Table
6.
1
Risks
of
Pseudozyma
flocculosa
strain
PF
A22
UL
to
non
target
organisms
Organism
Exposure
Test
Substance
Conclusions
Birds
Oral/
Pulmonary
/
Inhalation
/
Injection
Waiver
rationale
submitted
in
lieu
of
data
The
waiver
rationale
submitted
by
the
company
was
ACCEPTED
based
on
a
limited
potential
for
risk.
Wild
mammals
Acute
Waiver
rationale
submitted
in
lieu
of
data
The
waiver
rationale
submitted
by
the
company
was
ACCEPTED
based
on
a
limited
potential
for
risk.
Freshwater
fish
Acute
Waiver
rationale
submitted
in
lieu
of
data
The
waiver
rationale
submitted
by
the
company
was
ACCEPTED
based
on
a
limited
potential
for
risk.
Arthropods
Acute
Waiver
rationale
submitted
in
lieu
of
data
The
waiver
rationale
submitted
by
the
company
was
ACCEPTED
based
on
a
limited
potential
for
risk.
Non
arthropod
invertebrates
Acute
Waiver
rationale
submitted
in
lieu
of
data
The
waiver
rationale
submitted
by
the
company
was
ACCEPTED
based
on
a
limited
potential
for
risk.
Microorganisms
Acute
Waiver
rationale
submitted
in
lieu
of
data
Although
non
target
microorganisms
may
be
at
potential
risk,
the
waiver
rationale
submitted
by
the
company
was
ACCEPTED
based
on
limited
host
range.
Plants
Acute
Waiver
rationale
submitted
in
lieu
of
data
The
waiver
rationale
submitted
by
the
company
was
ACCEPTED
based
on
a
limited
potential
for
risk.
Product
Monograph
Pseudozyma
flocculosa
strain
PF
A22
UL
30
6.8
Integrated
environmental
toxicology
summary
Acceptable
waiver
rationales
were
submitted
to
address
environmental
toxicology
requirements.
These
waivers
were
based
on
minimal
increased
exposure
of
non
target
organisms
resulting
from
greenhouse
use
of
SPORODEX
L.
No
reports
of
adverse
effects
on
birds,
wild
mammals,
freshwater
fish,
aquatic
and
terrestrial
arthropods,
non
arthropod
invertebrates,
and
aquatic
and
terrestrial
plants
organisms
have
been
reported
in
the
literature.
Studies
to
assess
the
effect
of
P.
flocculosa
on
these
organisms
are
not
required.
Pseudozyma
flocculosa
is
a
saprophytic
fungal
epiphyte
and
a
hyperparasite
of
powdery
mildew.
Rapid
death
and
collapse
of
susceptible
host
cells
occurs
via
the
secretion
of
three
fungitoxic
unsaturated
C
17
fatty
acids
and
an
acyclic
norterpene.
The
fungitoxins
disrupt
susceptible
plasma
membranes
and
cytoplasmic
organelles
while
the
acyclic
norterpene
has
limited
antifungal
potential.
Despite
the
mode
of
action
associated
with
P.
flocculosa,
its
host
range
is
limited
to
mainly
powdery
mildews
(e.
g.,
Sphaerotheca
pannosa
var.
rosae,
S.
fulginea,
Erysiphe
graminis
var
tritici
and
E.
polygoni).
Although
in
vitro
bioassays
have
shown
that
soil
borne
fungi
such
as
Trichoderma,
Fusarium,
Pythium,
Phytophthora
and
Rhizoctonia
species
and
selected
Gramnegative
(e.
g.,
Xanthomonas
campestris)
and
Gram
positive
(e.
g.,
Bacillus
subtilis)
bacteria
were
weakly
to
moderately
susceptible
to
P.
flocculosa,
P.
flocculosa
being
a
phyllosphere
epiphyte
and
a
non
rhizosphere
competent
organism
is
not
expected
to
have
significant
effects
on
soil
borne
microorganisms.
Based
on
the
limited
host
range
of
P.
flocculosa,
no
non
target
microorganism
testing
will
be
required.
The
formulants
in
the
end
use
product
do
not
pose
an
environmental
risk
when
used
at
the
proposed
concentrations
and
application
rate
for
control
of
powdery
mildew
on
roses
and
cucumbers
grown
in
greenhouses.
Chapter
7
Efficacy
data
and
information
A
summary
of
the
efficacy
data
and
information
are
provided
below.
7.1
Effectiveness
7.1.1
Intended
use
For
control
of
powdery
mildew
in
greenhouse
crops:
cut
roses
or
cucumbers
or
potted
roses.
Mix
500
mL
of
SPORODEX
L
for
each
100
L
water
(or
64
U.
S.
fl
oz
per
100
U.
S.
gallons
of
water)
(equivalent
to
approximately
10
5
to
10
6
CFU/
mL).
Add
a
wetting
agent
at
0.
02%.
Apply
up
to
1500
L
of
water
per
ha
(or
150
U.
S.
gallons
of
spray
mixture
per
acre)
for
cut
roses
or
cucumbers
and
1000
L
per
ha
for
potted
roses
(or
100
U.
S.
gallons
per
acre)
.
Spray
foliage
of
plants
to
runoff
at
weekly
intervals,
beginning
when
environmental
conditions
favour
development
of
powdery
mildew
or
at
first
sign
of
the
disease.
Product
Monograph
Pseudozyma
flocculosa
strain
PF
A22
UL
31
Maintain
RH
above
70%
for
12
hours
after
application.
Use
of
chemical
fungicides
at
the
same
time
as
SPORODEX
may
inhibit
this
product's
activity
against
powdery
mildew.
Keep
frozen
at
20
o
C
or
less
in
the
freezer
until
use;
thaw
at
room
temperature
prior
to
using.
7.1.2
Mode
of
action
SPORODEX
L
is
a
liquid
formulation
containing
Pseudozyma
flocculosa
(synonym
Sporothrix
flocculosa)
at3x10
8
CFU/
mL.
The
strain
of
P.
flocculosa
that
is
the
basis
of
this
product
was
isolated
from
powdery
mildew
on
weeds
near
Harrow,
Ontario
in
1988.
It
has
been
found
to
be
antagonistic
to
most
species
of
powdery
mildew
pathogens,
and
appears
to
be
common
in
horticultural
and
agricultural
environments
where
powdery
mildews
are
found.
Host
range
may
include
antagonism
to
Sphaerotheca
and
Erysiphe
but
it
is
less
active
on
Trichoderma,
Fusarium,
Pythium,
Phytophthora
and
Rhizoctonia
according
to
in
vitro
bioassays.
Pseudozyma
destroys
the
integrity
of
host
cell
membranes
through
the
action
of
fatty
acid
metabolism,
causing
cell
leakage,
but
does
not
appear
to
colonize
host
hyphae.
Optimum
conditions
for
infection
of
host
fungi
are
26
o
C
and
>
70%
RH.
Pseudozyma
will
colonise
leaves
in
the
absence
of
powdery
mildew
but
undergoes
rapid
reproduction
only
when
the
disease
is
present.
7.1.3
Crops
SPORODEX
L
is
intended
for
use
on
greenhouse
roses
and
cucumbers.
7.1.4
Effectiveness
against
pest
Eleven
trials
with
Pseudozyma
flocculosa
on
cucumber
were
conducted
in
the
Netherlands
and
Canada
in
research
or
commercial
greenhouses.
Plants
were
grown
in
rockwool
according
to
normal
hydroponic
production
practices.
SPORODEX
WP
(two
early
formulations)
or
SPORODEX
L
were
applied
at
intervals
as
per
label
directions
to
plants
which
were
usually
inoculated
with
powdery
mildew
(Sphaerotheca
spp.)
For
comparison,
commercial
fungicide
standards
were
applied
as
needed.
Powdery
mildew
(%
diseased
leaf
area
on
whole
plants)
was
assessed
at
intervals
and
an
area
under
disease
progress
curve
(AUDPC)
for
the
whole
season
was
generated
for
comparison
of
treatments.
Cucumbers
were
harvested
and
graded,
and
total
yield
or
first
class
grade
yield
were
recorded.
In
seven
cucumber
trials,
based
on
total
disease
over
the
season,
SPORODEX
WP
provided
1848
control
which
was
significantly
different
from
the
check
but
less
than
that
provided
by
the
chemical
fungicides
(44
66%).
In
two
comparative
trials
under
moderate
disease
pressure,
a
newer
formulation
of
SPORODEX
WP
showed
significantly
better
control
(>
56%)
than
the
check
and
than
the
older
formulation
which
was
not
effective.
Yield
of
SPORODEX
treated
Product
Monograph
Pseudozyma
flocculosa
strain
PF
A22
UL
32
cucumbers
was
generally
greater
than
the
check
and
slightly
lower
than
chemically
treated
plants.
Rose
powdery
mildew
studies
were
conducted
in
Canadian
and
Columbian
greenhouses.
SPORODEX
WP
was
comparable
in
efficacy
to
various
chemical
fungicides
and
often
resulted
in
better
quality
or
yield
of
roses.
The
product
was
less
effective
where
high
humidity
was
not
maintained.
One
confirmatory
trial
with
the
proposed
SPORODEX
L
formulation
showed
that
it
is
as
effective
as
myclobutanil
against
powdery
mildew
on
cucumber.
In
this
trial,
an
application
of
pine
oil
(fertiliser)
in
midseason
adversely
affected
SPORODEX
L
which
resulted
in
lack
of
disease
control
on
lower
leaves
and
showed
that
this
product
is
not
compatible.
Results
are
available
from
two
additional
trials
in
the
Netherlands
and
B.
C.,
which
showed
that
reduction
of
powdery
mildew
and
improved
rose
yield
with
SPORODEX
L
were
comparable
to
results
with
dodemorph
acetate.
Efficacy
studies
showed
a
need
to
maintain
high
humidity
(>
70%
RH)
for
continued
viability
and
effectiveness
of
SPORODEX
products.
These
studies
show
that
SPORODEX
can
provide
comparable
efficacy
to
chemical
fungicide
sprays
in
controlling
powdery
mildew
and
improving
yield
of
cucumbers
and
quality
of
greenhouse
roses.
SPORODEX
significantly
reduced
powdery
mildew
compared
with
untreated
checks.
Although
the
early
formulation
was
not
as
effective
as
chemical
standards,
limited
trials
with
more
recent
formulations
suggest
that
SPORODEX
L
will
be
as
effective
as
chemical
standards
provided
that
high
humidity
is
maintained.
Further,
it
does
not
cause
phytotoxic
effects
which
indirectly
lowered
yields
as
were
seen
with
some
chemical
treatments.
The
proposed
rate
of
SPORODEX
L
was
500
mL
product
in
100
L
water,
applied
to
runoff
(1500
L/
ha
for
cut
roses
and
cucumbers
and
1000
L/
ha
for
potted
roses).
This
delivers
approximately
1
x
10
9
CFU/
L
of
P.
flocculosa
which
was
the
concentration
used
in
most
of
the
efficacy
trials
with
various
formulations.
A
lower
rate
may
also
be
effective
but
should
not
be
considered
until
crop
management
practices
have
developed
to
give
more
consistent
disease
control
performance
at
the
current
rate.
7.1.5
Total
spray
volume
Mix
500
mL
of
SPORODEX
L
for
each
100
L
water
(or
64
U.
S.
fl
oz
per
100
U.
S.
gallons
of
water)
(equivalent
to
approximately
10
5
to
10
6
CFU/
mL).
Add
a
wetting
agent
at
0.
02%.
Apply
up
to
1500
L
of
water
per
ha
(or
150
U.
S.
gallons
of
spray
mixture
per
acre)
for
cut
roses
or
cucumbers
and
1000
L
per
ha
for
potted
roses
(or
100
U.
S.
gallons
per
acre)
.
Spray
foliage
of
plants
to
runoff
at
weekly
intervals,
beginning
when
environmental
conditions
favour
development
of
powdery
mildew
or
at
first
sign
of
the
disease.
Product
Monograph
Pseudozyma
flocculosa
strain
PF
A22
UL
33
7.2
Phytotoxicity
to
target
plants
(including
different
cultivars),
or
to
target
plant
products
(OECD
7.
4)
No
adverse
effects
of
SPORODEX
formulations
were
noted
in
greenhouse
trials
with
cucumber
or
rose.
The
additive
paraffin
oil
(1%)
used
with
SPORODEX
was
noted
to
cause
a
slight
oedema
(water
blisters)
on
the
underside
of
rose
leaves
of
one
cultivar
and
the
use
of
oil
was
discontinued
in
that
trial.
The
oil
was
typically
used
at
lower
concentrations
in
other
trials
and
is
not
recommended
on
the
SPORODEX
L
label.
7.3
Observations
on
undesirable
or
unintended
side
effects
e.
g.
on
beneficial
and
other
non
target
organisms,
on
succeeding
crops,
other
plants
or
parts
of
treated
plants
used
for
propagating
purposes
(e.
g.
seed,
cutting,
runners)
(OECD
7.5)
SPORODEX
L
was
tested
in
commercial
greenhouses
throughout
its
development,
using
typical
production
practices
including
IPM
and
biological
control
organisms.
In
these
efficacy
trials,
observations
suggested
that
the
product
has
no
adverse
effect
on
crop
plants,
or
on
beneficial
insects
or
mites
with
respect
to
pest
control.
However,
direct
assays
to
confirm
no
adverse
effect
of
SPORODEX
L
on
specific
biocontrol
insects
and
arthropods
were
not
conducted.
7.3.1
Impact
on
succeeding
crops
(OECD
7.
5.
1)
Not
applicable
to
greenhouse
use.
7.3.2
Impact
on
adjacent
crops
(OECD
7.
5.
2)
Not
applicable
to
greenhouse
use;
adjacent
crops
(if
any)
are
typically
grown
within
separate
compartments.
7.3.3
Impact
on
seed
viability
(OECD
7.5.3)
Not
applicable
to
proposed
crops.
7.4
Economics
According
to
the
applicant,
the
farm
gate
value
of
greenhouse
cucumbers
in
Ontario
is
$25
million.
There
are
also
greenhouse
areas
in
BC,
Alberta
and
Quebec.
Crops
are
worth
$100
200
per
ha
annually.
There
are
about
24
ha
of
greenhouse
roses
in
Canada,
mostly
in
Ontario,
with
some
operations
in
BC,
Alberta
and
Quebec.
Grade
#1
roses
are
priced
at
$0.50
per
stem.
Although
it
rarely
affects
fruit,
powdery
mildew
spreads
rapidly
on
leaves
and
can
cause
a
loss
of
photosynthetic
area
and
water
stress,
leading
to
reduced
flower
production
or
yield
and
up
to
100%
loss.
Mildew
can
also
affect
marketability
and
price
of
roses
as
there
is
zero
tolerance
for
the
presence
of
white
mildew
spots
on
the
leaves
and
blooms
and
they
will
be
downgraded.
The
price
difference
to
growers
for
grade
#1
to
grade
#2
roses
is
$0.15
per
stem,
and
control
of
mildew
could
potentially
increase
revenues
by
$6,
000
per
ha.
Fungicides
are
currently
used
to
Product
Monograph
Pseudozyma
flocculosa
strain
PF
A22
UL
34
control
mildew
but
can
have
adverse
effects
on
yield,
fruit
and
flower
quality.
7.5
Sustainability
7.5.1
Survey
of
alternatives
Powdery
mildew
is
currently
managed
by
environment
control,
tolerant
cultivars,
sanitation
and
fungicides.
The
trend
in
greenhouse
production
is
to
reduce
chemical
pesticide
use
as
much
as
possible.
Thus,
there
is
a
need
for
alternative
products
to
use
in
the
disease
management
program.
7.5.1.1
Non
chemical
control
practices
Powdery
mildew
is
partly
managed
by
environment
control;
however
this
is
difficult
to
balance
because
the
different
stages
of
disease
development
are
favoured
by
different
conditions.
For
example,
both
low
humidity
and
free
water
on
leaves
followed
by
rapid
drying
have
been
found
to
reduce
disease,
yet
daily
fluctuations
in
humidity
can
increase
disease.
In
general,
growers
should
avoid
conditions
which
lead
to
succulent
foliage,
ie.
shading,
overcrowding,
overwatering
or
overfertilizing.
The
fungal
spores
will
not
survive
long
outside
of
host
plant
material,
so
a
thorough
cleanup
and
break
period
of
2
3
weeks
between
crops
can
reduce
carryover
of
inoculum.
Seedlings
which
are
already
started
should
be
cultivated
in
isolation
from
the
older
producing
plants.
Teardown
and
replant
of
the
cucumber
crop
is
a
labour
intensive
operation
due
to
the
volume
of
vine
material
handled,
so
the
plants
are
usually
maintained
as
long
as
is
profitable.
Mildew
resistant
cucumber
and
rose
cultivars
are
not
available
in
practice
for
Canadian
conditions;
although
some
tolerance
is
available,
these
cultivars
may
not
be
commercially
desirable.
For
instance,
in
B.
C.
cucumber
production,
more
resistant
varieties
are
grown
in
fall
when
mildew
pressure
is
high;
however,
they
are
lower
yielding
and
more
prone
to
Botrytis
and
gummy
stem
than
mildew
susceptible
varieties
grown
earlier
in
the
year.
Choice
of
rose
varieties
is
dependant
on
market
acceptability
for
colour
and
other
characteristics
rather
than
tolerance
to
powdery
mildew.
7.5.1.2
Chemical
Control
Practices
Few
chemical
products
are
available
for
powdery
mildew
control
in
greenhouses.
Benomyl,
myclobutanil,
and
sulfur
are
registered
in
Canada
for
cucumber
and
dodemorph
acetate
and
copper
are
registered
for
roses.
The
most
effective
products
are
systemic,
must
be
applied
frequently,
may
be
toxic
to
beneficials
and
are
prone
to
development
of
resistance
in
the
powdery
mildew
pathogens.
Both
myclobutanil
and
dodemorph
were
noted
to
cause
phytotoxicity
to
flowers
and
fruit
under
some
conditions
and
reduced
leaf
size
has
been
reported
for
both
cucumber
and
rose.
Benomyl
is
registered
but
not
expected
to
be
marketed
beyond
2001.
Silicon
has
been
investigated
as
a
disease
preventative,
either
applied
into
hydroponic
solution
or
as
a
foliage
spray,
but
has
not
been
consistently
effective
on
its
own.
Milsana
is
another
non
fungicidal
product
under
investigation
but
not
used
commercially
in
Canada.
The
trend
in
greenhouse
production
is
to
reduce
chemical
pesticide
use
as
much
as
possible.
Thus,
there
is
a
need
for
Product
Monograph
Pseudozyma
flocculosa
strain
PF
A22
UL
35
alternative
products
to
use
in
the
disease
management
program.
Table
7.
5
1
Alternative
disease
control
products
Active
Ingredient
End
Use
Products
Fungicide
Activity
Site
Application
Rate
(product/
1000
L)
Comments
Cucumber
Rose
Benomyl
Benlate
50WP
(+
Manzate)
tubulin
(multisite)
550
850
g
2.25
kg
No
longer
marketed
prone
to
resistance
Myclobutanil
Nova
40W
demethylation
340
g/
ha
Can
affect
leaf
and
fruit
growth,
prone
to
resistance
Sulfur
Kumulus,
MicroNiasul
multisite
1.
2
1.
5
kg
Harmful
to
some
beneficial
mites,
can
be
phytotoxic
Copper
Phyton
27
multisite
1.
25
2.
5
L
Dodemorph
acetate
Meltatox
40EC
isomerase
2.
5
L
Can
reduce
bloom
quality
7.5.2
Compatibility
with
current
management
practices
including
IPM
SPORODEX
L
has
potential
to
reduce
or
replace
chemical
fungicide
sprays
on
cucumbers
and
roses
and
efficacy
trials
showed
that
it
can
be
alternated
with
some
of
these
products.
SPORODEX
L
also
appears
to
be
compatible
with
IPM
practices
for
control
of
insects
and
mites
(see
section
7.
3).
However,
SPORODEX
L
has
not
been
tested
for
compatibility
with
all
chemical
products
or
with
other
microbial
disease
control
organisms;
therefore
the
grower
should
be
referred
to
the
manufacturer
for
updated
information.
IPM
practices
currently
include
the
monitoring
of
crop
for
signs
of
early
disease
which
is
necessary
to
ensure
that
SPORODEX
L
is
applied
at
the
earliest
opportunity
for
maximum
effectiveness.
At
present,
the
value
of
SPORODEX
L
is
limited
by
its
susceptibility
to
changing
environmental
conditions.
Growers
and
extension
staff
will
need
to
invest
further
work
in
determining
the
best
local
production
practices
for
viability
and
efficacy
of
SPORODEX
L
in
the
greenhouse
to
obtain
optimum
powdery
mildew
control
and
thereby
reduce
the
need
for
chemical
products.
7.5.3
Contribution
to
risk
reduction
It
is
expected
that
SPORODEX
L
will
be
used
in
greenhouses
to
control
powdery
mildew
in
situations
of
lower
disease
pressure
and
at
the
beginning
of
the
growing
season
to
delay
the
progress
of
the
disease.
In
this
way
it
may
aleviate
or
defer
the
need
for
chemical
fungicide
applications
thus
reducing
the
associated
risks
of
pesticide
resistance,
effects
to
workers
and
to
the
environment.
Product
Monograph
Pseudozyma
flocculosa
strain
PF
A22
UL
36
7.5.4
Information
on
the
occurrence
or
possible
occurrence
of
the
development
of
resistance
Powdery
mildew
pathogens
have
been
known
to
develop
resistance
to
chemical
fungicides;
however,
resistance
to
Pseudozyma
flocculosa
is
less
likely
because
of
its
broad
mode
of
action
and
lack
of
persistence
on
the
crop
plant.
Pseudozyma
flocculosa
destroys
the
integrity
of
host
cell
membranes,
causing
cell
leakage.
Optimum
conditions
for
colonization
do
not
occur
continuously
in
the
greenhouse
environment.
It
will
colonise
leaves
in
the
absence
of
powdery
mildew
but
undergoes
rapid
reproduction
only
when
the
disease
is
present.
For
these
reasons,
it
is
not
anticipated
that
resistance
to
P.
flocculosa
will
develop;
however,
as
a
general
principal,
it
is
best
not
to
rely
continuously
on
any
one
product
for
disease
control.
SPORODEX
L
does
have
a
role
in
prolonging
effectiveness
of
chemical
fungicides.
By
reducing
pathogen
populations
and
the
number
of
fungicide
sprays
applied
for
control
of
powdery
mildew,
SPORODEX
L
may
reduce
pressure
on
the
pathogen
to
develop
resistance
to
more
site
specific
fungicides.
7.6
Conclusions
7.6.1
Summary
SPORODEX
L
is
a
liquid
formulation
containing
Pseudozyma
flocculosa
at
3
x
10
8
CFU/
mL
for
control
of
powdery
mildew
in
greenhouse
roses
and
cucumbers.
The
proposed
rate
of
SPORODEX
L
is
500
mL
product
in
100
L
water
(or
64
U.
S.
fl
oz
per
100
U.
S.
gallons
of
water),
applied
to
runoff
(1500
L/
ha
for
cut
roses
and
cucumbers
(or
150
U.
S.
gallons
of
spray
mixture
per
acre)
and
1000
L/
ha
for
potted
roses
(or
100
U.
S.
gallons
per
acre)).
Eleven
trials
with
Pseudozyma
flocculosa
on
cucumber
were
conducted
in
the
Netherlands
and
Canada
in
research
or
commercial
greenhouses.
Five
rose
powdery
mildew
studies
were
conducted
in
Canadian
and
Columbian
greenhouses.
SPORODEX
significantly
reduced
powdery
mildew
compared
with
untreated
checks.
Although
the
early
formulation
was
not
as
effective
as
chemical
standards,
limited
trials
with
more
recent
formulations
suggest
that
SPORODEX
L
will
be
as
effective
as
chemical
standards
provided
that
high
humidity
is
maintained.
Further,
it
does
not
cause
phytotoxic
effects
which
indirectly
lowered
yields
as
were
seen
with
some
chemical
treatments.
Further
work
is
needed
on
managing
the
greenhouse
environment
for
full
disease
control
benefits
of
SPORODEX
L
to
be
realized.
SPORODEX
L
is
a
microbial
product
which
may
be
affected
by
co
application
of
fungicides
and
other
products.
The
label
precautions
should
be
expanded
to
advise
the
grower
of
this
and
include
guidance
for
better
performance.
SPORODEX
L
has
not
been
shown
to
adversely
affect
Product
Monograph
Pseudozyma
flocculosa
strain
PF
A22
UL
37
other
tools
such
as
biocontrol
agents,
shows
no
phytotoxic
effects
on
the
crop
and
is
generally
compatible
with
IPM
practices
which
are
being
adopted
for
greenhouse
production.
Table
7.
6
1
Summary
of
label
proposals
and
recommendations
Proposed
Recommendation
(based
on
Value
Assessment)
Greenhouse
crops
Cucumber
as
proposed
Roses
(potted
or
cut)
as
proposed
Rate
500
mL
/100L
of
water
(or
64
U.
S.
fl
oz
per
100
U.
S.
gallons
of
water)
with
20
mL
wetting
agent
(3
U.
S.
fl
oz).
Use
up
to
1500
L
spray
per
ha
for
cut
roses,
cucumbers
(or
150
U.
S.
gallons
of
spray
mixture
per
acre)
,
up
to
1000
L
for
potted
roses
(or
100
U.
S.
gallons
per
acre)
as
proposed
Application
method
Diluted
spray
applied
to
foliage
to
runoff
as
proposed
Timing
of
applications
Weekly
from
first
disease
or
when
environmental
conditions
favour
development
of
disease
as
proposed
Conditions
Maintain
RH
>70%
for
12
hours
Donotapplyatsame
time
as
chemical
fungicides
provide
additional
details/
guidance
Chapter
8
Overall
risk
assessment
conclusions
8.1
Product
characterization
and
analysis
The
product
characterization
data
for
both
Pseudozyma
flocculosa
strain
PF
A22
UL
and
SPORODEX
L
are
adequate
to
assess
their
safety
to
human
health.
The
technical
material
was
fully
characterized
and
the
specifications
were
supported
by
the
analysis
of
a
sufficient
number
of
batches.
Quality
control
procedures
employed
during
product
manufacture
and
formulation
are
adequate
to
ensure
an
absence
of
contaminating
microorganisms
of
concern
including
primary
human
and
animal
pathogens.
However,
due
to
the
microbial
contamination
noted
in
the
representative
quality
control
data,
the
submission
of
certificates
of
analysis
will
be
required
for
all
production
batches
of
SPORODEX
L
as
a
condition
of
registration
by
the
PMRA
and
the
EPA.
Product
Monograph
Pseudozyma
flocculosa
strain
PF
A22
UL
38
Additional
storage
stability
data
on
pilot
scale
or
production
scale
batches
are
required
to
ensure
product
performance
and
safety.
Until
these
data
are
available,
an
expiration
date
of
3
months
when
the
product
is
stored
at
20
C
is
required
on
the
product
labels.
8.2
Toxicity
and
infectivity
The
acute
toxicity
and
infectivity
studies
submitted
in
support
of
P.
flocculosa
and
of
SPORODEX
L
were
determined
to
be
sufficiently
complete
to
permit
a
decision
on
registration.
Pseudozyma
flocculosa
was
of
low
toxicity
in
the
rat
when
administered
via
the
oral
and
dermal
routes.
Slight
toxicity
was
observed
when
P.
flocculosa
was
administered
via
the
pulmonary
and
intraperitoneal
routes.
Pseudozyma
flocculosa
was
not
pathogenic
or
infective
via
the
oral
and
intraperitoneal
routes.
Pathogenicity
via
the
pulmonary
route
could
not
be
determined.
No
dermal
irritation
was
observed
but
mild
ocular
irritation
was
noted.
Waiver
requests
were
submitted
to
address
the
use
of
alternative
test
substances
(e.
g.,
SPORODEX
WP,
MPCA
produced
by
the
test
facility)
in
the
acute
toxicity
and
infectivity
studies.
These
waivers
were
based
on
the
nature
of
the
formulation
ingredients
in
SPORODEX
L
and
the
reduced
irritation
potential
of
a
liquid
formulation
compared
to
that
of
a
wettable
powder
formulation.
8.3
Exposure
The
potential
for
dermal,
eye
and
inhalation
exposure
for
pesticide
handlers
exists,
with
the
major
source
of
exposure
to
workers
being
generally
dermal.
To
mitigate
dermal
and
inhalation
exposure
and
risk
to
workers
during
mixing/
loading,
application
and
post
application
activities,
use
of
appropriate
Personal
Protective
Equipment
(PPE)
will
be
required.
PPE
will
include
longsleeved
shirts,
long
pants,
waterproof
gloves,
dust/
filter
respirator,
shoes
and
socks.
Furthermore
a
Restricted
Entry
Interval
(REI)
of
4
hours
is
required
for
early
entry
(post
application)
workers
or
other
persons
entering
treated
greenhouses.
It
is
assumed
that
most
microorganisms
contain
substances
that
would
elicit
positive
hypersensitivity
reactions.
Pseudozyma
flocculosa
strain
PF
A22
UL
is
considered
a
potential
sensitizing
agent,
and
a
"POTENTIAL
SENSITIZER"
statement
will
be
required
on
the
principal
display
panel
of
the
TGAI
and
end
use
formulation
labels.
8.4
Food
and
feed
residues
Although
Pseudozyma
species
are
ubiquitous
in
nature
and
have
been
isolated
from
a
wide
variety
of
plant
surfaces
including
leaf
litter,
clover,
maize
and
cucumber,
no
adverse
effects
from
dietary
exposure
have
been
attributed
to
natural
populations
of
Pseudozyma
flocculosa.
Residues
of
the
active
micoorganism
can
be
easily
removed
from
treated
commodities
by
washing,
cooking,
peeling
and
processsing.
Even
if
residues
are
not
removed,
dietary
exposure
to
the
microbial
agent
is
unlikely
to
result
in
any
undue
hazard
to
consumers
because
no
adverse
effects
were
observed
at
maximum
hazard
dose
levels
in
the
submitted
Tier
I
acute
oral
study.
Furthermore,
an
extensive
literature
search
yielded
no
reports
of
mammalian
toxins
being
produced
by
P.
flocculosa.
Based
on
the
low
level
of
toxicity
and
lack
of
pathogenic
potential
for
the
active
microorganism
observed
in
the
Tier
I
acute
oral
study,
there
are
no
acute,
subchronic
or
chronic
Product
Monograph
Pseudozyma
flocculosa
strain
PF
A22
UL
39
toxicological
concerns
for
P.
flocculosa.
Therefore,
the
establishment
of
a
a
tolerance
for
residues
of
P.
flocculosa
strain
PF
A22
UL
is
not
required
(rather
an
exemption
from
the
requirement
of
a
tolerance
will
be
granted)
as
defined
under
Section
408
of
the
Federal
Food
Drug
and
Cosmetic
Act.
8.5
Environmental
assessment
Acceptable
waivers
were
submitted
to
address
environmental
toxicology
requirements.
Nontarget
organisms,
including
birds,
wild
mammals,
freshwater
fish,
aquatic
and
terrestrial
arthropods,
non
arthropod
invertebrates,
and
aquatic
and
terrestrial
plants
are
not
expected
to
face
increased
exposure
to
P.
flocculosa
due
to
use
of
SPORODEX
L
in
commercial
greenhouses.
No
reports
of
adverse
effects
on
these
non
target
organisms
have
been
reported
in
the
literature.
Studies
to
assess
the
effect
of
P.
flocculosa
on
these
organisms
are
not
required.
Pseudozyma
flocculosa
is
a
saprophytic
fungal
epiphyte
and
a
hyperparasite
of
powdery
mildew.
Rapid
death
and
collapse
of
susceptible
host
cells
occurs
via
the
secretion
of
three
fungitoxic
unsaturated
C
17
fatty
acids
and
an
acyclic
norterpene.
The
fungitoxins
disrupt
susceptible
plasma
membranes
and
cytoplasmic
organelles
while
the
acyclic
norterpene
has
limited
antifungal
potential.
Despite
the
mode
of
action
associated
with
P.
flocculosa,
its
host
range
is
limited
to
mainly
powdery
mildews
(e.
g.,
Sphaerotheca
pannosa
var.
rosae,
S.
fulginea,
Erysiphe
graminis
var
tritici
and
E.
polygoni).
Although
in
vitro
bioassays
have
shown
that
soil
borne
fungi
such
as
Trichoderma,
Fusarium,
Pythium,
Phytophthora
and
Rhizoctonia
species
and
selected
Gramnegative
(e.
g.,
Xanthomonas
campestris)
and
Gram
positive
(e.
g.,
Bacillus
subtilis)
bacteria
were
weakly
to
moderately
susceptible
to
P.
flocculosa,
P.
flocculosa
being
a
phyllosphere
epiphyte
and
a
non
rhizosphere
competent
organism
is
not
expected
to
have
significant
effects
on
soilborne
microorganisms.
Based
on
the
limited
host
range
of
P.
flocculosa,
no
non
target
microorganism
testing
will
be
required.
The
formulants
in
the
end
products,
SPORODEX
L,
do
not
pose
an
environmental
risk
when
used
at
the
proposed
concentrations
and
application
rate
for
control
of
powdery
mildew
on
roses
and
cucumbers
grown
in
greenhouses.
Consequently,
SPORODEX
L
is
expected
to
pose
little
environmental
risk
when
used
in
accordance
with
the
label
directions.
Furthermore,
no
special
precautionary
or
environmental
hazard
statement
is
required
on
the
label
for
SPORODEX
L.
8.
6
Efficacy
assessment
SPORODEX
L
applied
at
proposed
label
rates
can
be
effective
in
controlling
powdery
mildew
on
greenhouse
cucumber
and
roses
provided
that
high
humidity
is
maintained.
Further
work
is
needed
on
managing
the
greenhouse
environment
for
full
disease
control
benefits
of
SPORODEX
L
to
be
realized.
SPORODEX
L
has
not
been
shown
to
adversely
affect
other
tools
such
as
biocontrol
agents,
shows
no
phytotoxic
effects
on
the
crop
and
is
generally
compatible
with
IPM
practices
which
are
being
adopted
for
greenhouse
production.
Chapter
9
Risk
Management
Considerations
Product
Monograph
Pseudozyma
flocculosa
strain
PF
A22
UL
40
9.1
Public
interest
finding
The
Agency
believes
the
use
of
Pseudozyma
flocculosa
strain
PF
A22
UL
under
this
conditional
registration
would
be
in
the
public
interest.
The
criteria
for
Agency
evaluation
of
public
interest
findings
is
outlined
in
51
CFR
No.
43,
Wednesday
March
5,
1986.
Under
part
IV.
A.,
the
proposed
product
may
qualify
for
an
automatic
presumptive
finding
if
it
is
for
minor
use,
is
a
unique
replacement
for
pesticides
of
concern,
or
is
for
use
against
a
public
health
pest.
Pseudozyma
flocculosa
strain
PF
A22
UL
is
intended
for
formulation
into
end
use
products
for
control
of
powdery
mildew
on
greenhouse
grown
cucumbers
and
roses.
These
uses
are
for
minor
use
crops
and,
therefore,
the
product
qualifies
for
an
automatic
presumptive
finding
and
its
use
is
presumed
to
be
in
the
public
interest.
9.2
Determination
of
3(
c)(
7)(
C)
eligibility
Pursuant
to
FIFRA
section
3(
c)(
7)(
C),
EPA
may
conditionally
register
a
new
pesticide
active
ingredient
if:
1)
insufficient
time
has
elapsed
since
the
imposition
of
the
data
requirement
for
those
data
to
be
developed
and
all
other
required
data
have
been
submitted,
2)
the
use
of
the
pesticide
product
during
the
period
of
the
conditional
registration
will
not
cause
any
unreasonable
adverse
effect
on
human
health
and
the
environment,
and
3)
the
registration
and
the
use
of
the
pesticide
during
the
conditional
registration
is
in
the
public
interest.
The
Agency
believes
that
all
these
criteria
have
been
fulfilled.
For
Pseudozyma
flocculosa
strain
PF
A22
UL
and
the
end
product,
SPORODEX
L,
the
first
criterion
under
FIFRA
section
3(
c)(
7)(
C)
mentioned
above
has
been
met.
Insufficient
time
has
elapsed
since
the
imposition
of
the
following
outstanding
confirmatory
data
requirement:
Acute
Pulmonary
Toxicity/
Pathogenicity.
Agency
scientists
have
reviewed
the
data
submitted
or
cited
by
Plant
Products
Co.
Ltd.
with
respect
to
health
effects
and
ecological
effects
and
have
identified
no
unreasonable
adverse
effects
to
human
health
or
to
non
target
organisms.
However,
to
confirm
these
expected
results,
the
additional
data
described
below
will
be
required
as
a
condition
of
registration.
A
complete
acute
pulmonary
toxicity
/
pathogenicity
study
(U.
S.
EPA
OPPTS
885.3150)
must
be
conducted
using
the
technical
grade
active
ingredient
(TGAI)
(Pseudozyma
flocculosa
strain
PF
A22
UL)
and
the
sterile
filtrate
of
the
production
culture.
The
two
acute
pulmonary
studies
that
were
submitted
did
not
have
fully
acceptable
toxicity
and
pathogenicity
results
contained
in
a
single
study.
Both
of
these
studies
were
considered
supplemental.
However,
taken
together,
parts
of
each
study
were
acceptable
for
making
a
regulatory
decision.
That
is,
the
acute
pulmonary
toxicity/
pathogenicity
study
had
acceptable
pathogenicity
data,
but
not
toxicity
data
and
the
acute
pulmonary
toxicity/
pathogenicity
range
finding
study
had
acceptable
toxicity
data,
but
did
not
address
pathogenicity.
In
addition,
the
Agency
decided
that
it
would
be
prudent
to
test
the
sterile
filtrate
of
the
production
batch
to
Product
Monograph
Pseudozyma
flocculosa
strain
PF
A22
UL
41
determine
whether
there
were
any
toxic
components
of
concern.
Testing
the
sterile
filtrate
would
not
have
been
foreseeable
by
the
registrant
and
a
period
reasonable
sufficient
for
generation
of
the
data
has
not
elapsed.
Thus,
a
confirmatory
acute
pulmonary
toxicity
/
pathogenicity
study
using
the
TGAI
and
testing
of
the
sterile
filtrate
from
the
production
culture
will
be
required
to
provide
this
additional
information
as
a
condition
of
registration.
This
study
must
be
submitted
to
the
EPA
no
later
than
October
3,
2003.
All
other
required
data
for
registration
have
been
submitted.
The
Agency
is
also
imposing
a
continuing
monitoring
requirement
on
the
registrant
as
a
term
of
registration;
this
requirement
is
not
a
3(
c)(
7)(
C)
condition
and
is
not
connected
to
the
two
year
term
of
the
conditional
registration.
In
addition,
the
registrant
may
submit
further
storage
stability
studies
to
support
a
change
in
the
labeling
to
increase
the
labeled
shelf
life
beyond
three
months.
The
submitted
storage
stability
study,
however,
is
sufficient
to
support
the
current
3
month
label
language.
The
applicant
has
submitted
or
cited
data
to
allow
EPA
to
make
the
finding
necessary
to
satisfy
the
second
criterion
for
conditional
registration
under
FIFRA
3(
c)(
7)(
C)
as
mentioned
above.
Plant
Products
Co.
Ltd.
submitted
and/
or
cited
satisfactory
data
pertaining
to
the
proposed
use.
The
human
health
effects
data
and
non
target
organism
effects
data
are
considered
sufficient
for
the
period
of
the
conditional
registration
(2
years).
These
data
demonstrate
that
no
foreseeable
human
health
hazards
or
ecological
effects
are
likely
to
arise
from
the
use
of
the
product
and,
under
the
terms
and
conditions
of
the
registration.
As
any
potential
inhalation
risk
that
is
raised
by
the
supplementary
acute
pulmonary
toxicity/
pathogenicity
data
is
primarily
a
worker
risk,
EPA
is
requiring
that
a
respirator
be
worn
by
workers
to
limit
any
inhalation
exposures.
In
addition,
a
Restricted
Entry
Interval
(REI)
of
4
hours
is
required
for
early
entry
(post
application)
workers
or
other
persons
entering
treated
greenhouses.
Accordingly,
the
Agency
has
concluded
that
use
of
the
pesticide
product
during
the
period
of
the
conditional
registration
will
not
cause
any
unreasonable
adverse
effect
on
human
health
and
the
environment
The
Agency
also
believes
that
the
third
criterion
for
a
FIFRA
3(
c)(
7)(
C)
conditional
registration
has
been
fulfilled
because
the
use
of
Pseudozyma
flocculosa
strain
PF
A22
UL
under
this
registration
would
be
in
the
public
interest.
The
criteria
for
Agency
evaluation
of
public
interest
findings
is
outlined
in
51
FR
7628
(Mar.
5,
1986).
The
proposed
product
qualifies
for
an
automatic
presumptive
finding
because
all
intended
uses
are
for
minor
use
crops,
i.
e.,
greenhousegrown
cucumbers
and
roses.
In
addition,
the
Agency
is
not
aware
of
any
other
information
which
would
alter
EPA's
presumption
that
use
of
this
pesticide
during
the
period
of
conditional
registration
would
be
in
the
public
interest.
Therefore,
Pseudozyma
flocculosa
strain
PF
A22
UL
is
eligible
for
a
FIFRA
3(
c)(
7)(
C)
conditional
registration.
The
proposed
registration
sites
are
for
greenhouse
grown
cucumbers
and
roses.
9.3
Terms
and
conditions
of
registration
The
active
ingredient
Pseudozyma
flocculosa
strain
PF
A22
UL,
and
the
formulated
product
SPORODEX
L
for
control
of
powdery
mildew
on
greenhouse
grown
roses
and
cucumbers
have
Product
Monograph
Pseudozyma
flocculosa
strain
PF
A22
UL
42
been
granted
temporary
registration
pursuant
to
Section
17
of
the
Pest
Control
Products
Regulations
(Canada/
PMRA)
and
a
conditional
registration
under
Section
3(
c)(
7)(
C)
of
the
Federal
Insecticide
Fungicide
and
Rodenticide
Act
(U.
S.
EPA).
This
FIFRA
3(
c)(
7)(
C)
conditional
registration
will
automatically
expire
at
midnight,
September
30,
2004.
The
following
list
gives
the
terms
and
conditions
of
the
registration.
1)
A
complete
acute
pulmonary
toxicity
/
pathogenicity
study
(U.
S.
EPA
OPPTS
885.3150)
must
be
conducted
using
the
technical
grade
active
ingredient
(TGAI)
(Pseudozyma
flocculosa
strain
PF
A22
UL)
and
the
sterile
filtrate
of
the
production
culture.
This
study
must
be
submitted
to
the
EPA
no
later
than
October
3,
2003.
2)
Certificates
of
analysis
must
be
submitted
to
the
Agency
prior
to
the
release
of
all
production
batches
of
SPORODEX
L
biological
fungicide
(U.
S.
EPA
OPPTS
885
1100
through
885
1600).
Bioassay
results,
conidial,
total
aerobic
flora,
enterobacteria,
enterococci,
fecal
coliform,
E.
coli,
Staphylococci
and
Salmonella
counts
must
be
determined
for
each
production
batch
and
be
included
in
each
certificate
of
analysis.
Certificates
of
analysis
must
be
submitted
until
sufficient
consistency
with
regards
to
microbial
contaminants
has
been
established.
3)
Additional
storage
stability
data
(OPPTS
830.6317)
derived
from
at
least
five
production
scale
or
pilot
scale
batches
are
required
to
ensure
product
performance
and
safety
during
the
shelf
life
of
the
product.
SPORODEX
L
Biological
Fungicide
should
be
tested
over
a
period
of
time
and
in
accordance
with
the
desired
storage
and
use
conditions
appearing
on
the
product
label.
An
interim
expiration
date
of
3
months
from
the
date
of
manufacture
when
SPORODEX
L
Biological
Fungicide
is
stored
at
20
C
is
required
until
additional
data
are
submitted
and
approved
by
the
Agency.
For
consideration
of
these
data
prior
to
the
expiration
date
of
the
conditional
registration,
additional
data
should
be
submitted
to
the
Agency
no
later
than
October
3,
2003.
4)
Finally,
although
a
skin
sensitization
study
on
the
microbial
active
ingredient
Pseudozyma
flocculosa
strain
PF
A22
UL
was
not
required
by
the
Agency,
the
reporting
of
any
incidents
of
hypersensitivity
subsequent
to
registration
is
a
standard
practice
for
microbial
products.
The
registrant
will
be
expected
to
report
any
subsequent
findings
of
hypersensitivity
or
other
health
incidents
to
workers,
applicators,
or
bystanders
exposed
to
the
MPCA
(microbial
pest
control
agent)
as
an
ongoing
condition
of
registration.
Incident
reports
under
FIFRA
section
6(
a)
2
are
to
include
details
such
as
a
description
of
the
MPCA
and
formulation,
frequency,
duration
and
routes
of
exposure
to
the
material,
clinical
observations,
and
any
other
relevant
information.
9.4
Tolerance
EPA
has
established
an
exemption
from
the
requirement
of
a
tolerance
for
residues
of
the
Pseudozyma
flocculosa
strain
PF
A22
UL
in
or
on
all
food
commodities.
Based
on
the
toxicology
data
submitted
and
other
relevant
information
in
the
Agency's
files,
there
is
reasonable
certainty
no
harm
will
result
from
aggregate
exposure
of
residues
of
Pseudozyma
flocculosa
strain
Product
Monograph
Pseudozyma
flocculosa
strain
PF
A22
UL
43
PF
A22
UL
to
the
U.
S.
population,
including
infants
and
children,
under
reasonably
foreseeable
circumstances
when
the
microbial
pesticide
product
is
used
as
labeled.
This
includes
all
anticipated
dietary
exposures
and
all
other
exposures
for
which
there
is
reliable
information.
The
Agency
has
arrived
at
this
conclusion
based
on
data
submitted
demonstrating
low
toxicity
at
the
maximum
doses
tested
and
a
lack
of
information
showing
adverse
effects
from
exposure
to
naturally
occurring
P.
flocculosa
as
well
as
a
consideration
of
the
product
as
currently
registered
and
labeled.
As
a
result,
EPA
establishes
an
exemption
from
tolerance
requirements
pursuant
to
FFDCA
408(
c)
and
(d)
for
residues
of
Pseudozyma
flocculosa
strain
PF
A22
UL
in
or
on
all
food
commodities.
FFDCA
section
408
provides
that
EPA
shall
apply
an
additional
tenfold
margin
of
exposure
(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
unless
EPA
determines
that
a
different
margin
of
exposure
(safety)
will
be
safe
for
infants
and
children.
Margins
of
exposure
(safety)
are
often
referred
to
as
uncertainty
(safety)
factors.
In
this
instance,
based
on
all
the
available
information,
the
Agency
concludes
that
P.
flocculosa
strain
PF
A22
UL
is
practically
non
toxic
to
mammals,
including
infants
and
children.
Thus,
there
are
no
threshold
effects
of
concern
and,
as
a
result
the
provision
requiring
an
additional
margin
of
safety
does
not
apply.
Further,
the
provisions
of
consumption
patterns,
special
susceptibility,
and
cumulative
effects
do
not
apply.
As
a
result,
EPA
has
not
used
a
margin
of
exposure
(safety)
approach
to
assess
the
safety
of
P.
flocculosa
strain
PF
A22
UL.
9.5
Codex
harmonization
There
are
no
Codex
harmonization
considerations
since
there
are
no
Codex
Maximum
Residue
Limits
set
for
food
use
of
this
active
ingredient.
9.6
Risk
mitigation
There
is
minimal
or
negligible
potential
risk
to
wildlife,
or
ground
and
surface
water
contamination
for
products
containing
this
active
ingredient.
Dietary
risk
will
be
adequately
mitigated
by
washing,
peeling,
cooking
and
processing
of
treated
foods.
To
mitigate
dermal
and
inhalation
exposure
and
risk
to
workers
during
mixing/
loading,
application
and
post
application
activities,
use
of
appropriate
Personal
Protective
Equipment
(PPE)
will
be
required.
PPE
will
include
long
sleeved
shirts,
long
pants,
waterproof
gloves,
dust/
filter
respirator,
shoes
and
socks.
Furthermore
a
Restricted
Entry
Interval
(REI)
of
4
hours
is
required
for
early
entry
postapplication
workers
or
other
persons
entering
treated
greenhouses.
It
is
assumed
that
most
microorganisms
contain
substances
that
would
elicit
positive
hypersensitivity
reactions.
Pseudozyma
flocculosa
strain
PF
A22
UL
is
considered
a
potential
sensitizing
agent,
and
a
"POTENTIAL
SENSITIZER"
statement
will
be
required
on
the
principal
display
panel
of
the
TGAI
and
end
use
formulation
labels.
No
special
precautionary
or
environmental
hazard
statements
are
required
on
the
label
for
SPORODEX
L.
There
are
no
reports
of
adverse
effects
due
to
the
use
of
P.
flocculosa.
Product
Monograph
Pseudozyma
flocculosa
strain
PF
A22
UL
44
Exposure
to
P.
flocculosa
due
to
use
of
SPORODEX
L
in
commercial
greenhouses
will
be
limited.
Studies
to
assess
the
effect
of
P.
flocculosa
on
these
organisms
are
not
required.
The
formulants
in
the
end
products,
SPORODEX
L,
do
not
pose
an
environmental
risk
when
used
at
the
proposed
concentrations
and
application
rate
for
control
of
powdery
mildew
on
roses
and
cucumbers
grown
in
greenhouses.
Consequently,
SPORODEX
L
is
expected
to
pose
little
environmental
risk
when
used
in
accordance
with
the
label
directions.
9.7
Endangered
species
The
Agency
has
no
evidence
to
believe
that
any
endangered
of
threatened
species
will
be
adversely
affected
if
products
containing
Pseudozyma
flocculosa
strain
PF
A22
UL
are
used
as
labeled
(i.
e.,
greenhouse
grown
cucumbers
and
roses).
Therefore,
the
Agency
has
determined
that
this
action
will
have
"no
effect"
on
listed
species.
No
specific
labeling
is
required.
9.8
Labels
and
labeling
It
is
Canada/
PMRA's
and
U.
S.
EPA's
position
that
the
labeling
for
products
containing
Pseudozyma
flocculosa
strain
PL
A22
UL
must
comply
with
the
current
pesticide
labeling
requirements.
SPORODEX
®
L
is
manufactured
following
a
continuous
manufacturing
process
that
does
not
involve
an
intermediate
stand
alone
technical
product.
9.8.1
End
use
product
(SPORODEX
®
L)
A
joint
U.
S./
Canada
NAFTA
label
containing
the
necessary
regulatory
language
for
SPORODEX
®
L
is
provided
below.
This
label
was
approved
by
Canada/
PMRA,
June
3,
2002.
DRAFT
U.
S./
CANADA
LABEL
(Front
Panel)
SPORODEX
L
BIOLOGICAL
FUNGICIDE
For
Control
of
Powdery
Mildew
on
Greenhouse
Roses
and
Cucumbers.
COMMERCIAL
READ
THE
LABEL
BEFORE
USING
POTENTIAL
SENSITIZER
ACTIVE
INGREDIENT/
GUARANTEE:
Pseudozyma
flocculosa
strain
PF
A22
UL
.
.
1.3%
OTHER
INGREDIENTS:
...............................................
98.
7%
TOTAL:
................................................
100.0%
(Contains
a
minimum
of
3
×
10
8
colony
forming
units/
mL)
KEEP
OUT
OF
REACH
OF
CHILDREN
Product
Monograph
Pseudozyma
flocculosa
strain
PF
A22
UL
45
CAUTION
U.
S.
EPA
Registration
No.:
(Pending
as
File
Symbol
69697
3)
U.
S.
EPA
Establishment:
69697
CAN
001
REGISTRATION
NUMBER
XXXXX
PEST
CONTROL
PRODUCTS
ACT
NetContents:
1
L(
32
U.
S.
floz)
Manufactured
by:
Plant
Products
Co.
Ltd.
314
Orenda
Road
Brampton,
Ontario
L6T
1G1,
Canada
905
793
7900
Distributed
by:
Plant
Products
Co.
Ltd.
6160
Riverside
Dr.
Suite
103
Dublin,
OH
43017
Lot
Number:
[XXX]
Date
of
manufacture:
[XXX]
Use
within
3
months
of
the
date
of
manufacture
KEEP
FROZEN
UNTIL
USE
Product
Monograph
Pseudozyma
flocculosa
strain
PF
A22
UL
46
(Back
Panel)
PRECAUTIONS
/
PRECAUTIONARY
STATEMENTS
HAZARDS
TO
HUMANS
AND
DOMESTIC
ANIMALS.
May
cause
sensitization.
Avoid
contact
with
skin,
eyes
or
clothing.
Avoid
breathing
mist.
Wash
thoroughlywith
soap
and
water
after
handling.
PERSONAL
PROTECTIVE
EQUIPMENT
(PPE):
Applicators
and
other
handlers
must
wear
long
sleeved
shirt
and
long
pants,
waterproof
gloves
and
shoes
plus
socks.
All
mixers/
loaders
and
applicators
must
wear
a
dust/
mist
filtering
respirator
(MSHA/
NIOSH
approval
number
prefix
TC21C
or
a
NIOSH
approved
respirator
with
any
N
95,
R
95,
P
95
or
HE
filter
for
biological
products.
Remove
contaminated
clothing
and
follow
manufacturer's
instructions
for
cleaning
/
maintaining
PPE
before
reuse.
If
no
such
instructions
are
available
use
clothing
detergent
and
hot
water
for
cleaning
all
washable
PPE.
Keep
and
wash
PPE
separately
from
other
laundry.
USER
SAFETY
RECOMMENDATIONS:
Users
should
wash
hands
before
eating,
drinking,
chewing
gum,
using
tobacco
or
using
the
toilet.
Remove
PPE
immediately
after
handling
this
product.
Wash
the
outside
of
gloves
before
removing.
As
soon
as
possible,
wash
thoroughly
and
change
into
clean
clothing.
ENVIRONMENTAL
HAZARDS
Do
not
apply
directly
to
water,
or
to
areas
where
surface
water
is
present,
or
to
intertidal
areas
below
the
mean
highwater
mark.
Do
not
contaminate
water
by
cleaning
of
equipment
or
disposal
of
equipment
washwaters.
FIRST
AID
If
on
skin
or
clothing
Take
off
contaminated
clothing.
Rinse
skin
immediately
with
plenty
of
water
for
15
–
20
minutes.
Call
a
poison
control
center
or
doctor
for
treatment
advice.
If
inhaled
Move
person
to
fresh
air.
If
person
is
not
breathing,
call
911
or
an
ambulance,
then
give
artificial
respiration,
preferably
by
mouth
to
mouth,
if
possible.
Call
a
poison
control
center
or
doctor
for
treatment
advice.
If
in
eyes
Hold
eye
open
and
rinse
slowly
and
gently
with
water
for
15
20
minutes.
Remove
contact
lenses,
if
present,
after
the
first
5
minutes,
then
continue
rinsing
eye.
Call
a
poison
control
center
or
doctor
for
treatment
advice.
If
swallowed
Call
a
poison
control
center
or
doctor
immediately
for
treatment
advice.
Have
person
sip
a
glass
of
water
if
able
to
swallow.
Do
not
induce
vomiting
unless
told
to
do
so
by
the
poison
control
center
or
doctor.
Do
not
give
anything
by
mouth
to
an
unconscious
person.
Product
Monograph
Pseudozyma
flocculosa
strain
PF
A22
UL
47
Seek
medical
attention
IMMEDIATELY
if
irritation
occurs
and
persists
or
is
severe.
Have
container,
label
or
product
name
and
product
registration
number
with
you
when
calling
a
poison
control
center
or
doctor,
or
when
seeking
medical
attention.
TOXICOLOGICAL
INFORMATION
/
NOTE
TO
PHYSICIAN
No
specific
antidote
is
available.
Treat
the
patient
symptomatically.
DIRECTIONS
FOR
USE
In
the
U.
S.
It
is
a
violation
of
Federal
law
to
use
this
product
in
a
manner
inconsist
ent
with
its
labeling.
For
any
requirements
specific
to
your
State
or
Tribe,
consult
the
agency
responsible
for
pesticide
regulation.
Do
not
apply
this
product
in
a
way
that
will
contact
workers
or
other
persons,
either
directly
or
thorough
drift.
Only
protected
handlers
may
be
in
the
area
during
application.
In
Canada
NOTICE
TO
USER:
This
control
product
is
to
be
use
only
in
accordance
with
the
directions
on
this
label.
It
is
an
offence
under
the
PEST
CONTROL
PRODUCTS
ACT
to
use
a
control
product
under
unsafe
conditions.
In
the
U.
S.
Agricultural
Use
Requirements
Use
this
product
only
in
accordance
with
its
labeling
and
with
the
Worker
Protection
Standard,
40
CFR
Part
170.
This
standard
contains
requirements
for
the
protection
of
agricultural
workers
on
farms,
forests,
nurseries
and
greenhouses,
and
handlers
of
agricultural
pesticides.
It
contains
requirements
for
training,
decontamination,
notification,
and
emergency
assistance.
It
also
contains
specific
instructions
and
exceptions
pertaining
to
the
statements
on
this
label
about
personal
protective
equipment
(PPE),
and
restricted
entry
intervals
(REI).
The
requirements
in
this
box
only
apply
to
uses
of
this
product
that
are
covered
by
the
Worker
Protection
Standard.
Do
not
enter
or
allow
worker
entry
into
treated
areas
during
the
restricted
entry
interval
of
4
hours.
PPE
requirement
for
early
entry
to
treated
areas
that
is
permitted
under
the
Worker
Protection
Standard
and
that
involves
contact
with
anything
that
has
been
treated,
such
as
plants,
soil
or
water,
is
coveralls,
waterproof
gloves
and
shoes
plus
socks.
In
Canada
Do
not
enter
or
allow
worker
entry
into
treated
areas
during
the
restricted
entry
interval
(REI)
of
4
hours.
Workers
can
enter
treated
areas
during
the
REI
if
appropriate
PPE
is
worn,
including
a
long
sleeved
shirt,
long
pants,
shoes
plus
socks
and
waterproof
gloves
as
well
as
a
NIOSH
approved
respirator
with
any
N
95,
R
95,
P
95
or
HE
filter
for
biological
products.
GENERAL
INFORMATION
SPORODEX
L
is
a
naturally
occurring
fungus
which
is
an
antagonist
to
the
powdery
mildew
disease
organism.
SPORODEX
L
is
an
aqueous
liquid
formulation
of
Pseudozyma
flocculosa
formulated
to
control
powdery
mildew
disease
on
the
listed
crops.
Product
Monograph
Pseudozyma
flocculosa
strain
PF
A22
UL
48
APPLICATION
RATES
CROP
DISEASE
RATE
Greenhouse
roses
Greenhouse
cucumbers
Powdery
mildew
disease
In
U.
S.
and
Canada:
500
mL
per
100
L
of
water.
Add
20
mLofanappropriate
wetting
agent
per
100
L
of
spray
mixture.
or
64
U.
S.
fl
oz
per
100
U.
S.
gallons
of
water.
Add
3
U.
S.
fl
oz
of
an
appropriate
wetting
agent
per
100
U.
S.
gallons
of
spray
mixture.
Add
SPORODEX
L
to
water.
Spray
foliage
to
run
off
at
weekly
intervals,
beginning
when
environmental
conditions
favor
development
of
powdery
mildew,
or
at
first
sign
of
disease.
Apply
up
to
1500
L
of
spray
mixture
per
hectare
(150
U.
S.
gallons
of
spray
mixture
per
acre)
for
cut
roses,
cucumbers
or
about
1000
L
per
hectare
(100
U.
S.
gallons
per
acre)
for
potted
roses.
Maintain
relative
humidity
above
70%
for
12
hours
after
application,
for
example,
by
using
shade
curtain
or
by
applying
SPORODEX
L
late
in
the
day
or
during
prolonged
cloudy
conditions.
NOTE:
Use
of
chemicals
at
the
same
time
as
SPORODEX
L
may
inhibit
this
product's
activity
against
powdery
mildew.
Do
not
tank
mix
SPORODEX
L
with
chemical
pesticides.
SPORODEX
L
has
not
been
tested
for
compatibility
with
all
chemical
and
biological
products
(including
biological
control
insects
and
arthropods)
used
in
greenhouse
production.
For
details
on
compatibility
contact
the
distributor
or
manufacturer,
or
test
effectiveness
on
a
small
number
of
plants
prior
to
commercial
scale
use.
STORAGE
AND
DISPOSAL
Do
not
contaminate
water,
food
or
feed
by
storage
or
disposal.
Pesticide
Storage:
Store
frozen
at
20
C
(
4
F)
or
less
and
keep
away
from
food
or
feed.
Keep
product
in
original
container
during
storage
and
keep
container
lid
tightly
closed
when
not
in
use.
This
product
should
be
used
within
3
months
of
the
date
of
manufacture
when
stored
at
20
C
(
4
F).
Thaw
at
room
temperature
prior
to
using.
In
the
U.
S.
Pesticide
Disposal:
Wastes
resulting
from
the
use
of
this
product
may
be
disposed
of
on
site
or
at
an
approved
waste
disposal
facility.
Container
Disposal:
Completelyemptypackage
into
application
equipment.
Then
dispose
of
empty
package
in
a
sanitary
landfill
or
by
incineration,
or,
if
allowed
by
State
and
local
authorities,
by
burning.
If
burned,
stay
out
of
smoke.
Do
not
reuse
container.
Product
Monograph
Pseudozyma
flocculosa
strain
PF
A22
UL
49
In
CanadaDISPOSAL
1.
Triple
or
pressure
rinse
the
empty
container.
Add
the
rinsings
to
the
spray
to
the
spray
mixture
in
the
tank.
2.
Follow
provincial
instruction
for
any
required
additional
cleaning
of
the
container
prior
to
its
disposal.
3.
Make
the
container
unsuitable
for
further
use.
4.
Dispose
of
the
container
in
accordance
with
provincial
requirements.
5.
For
information
on
the
disposal
of
unused,
unwanted
product,
contact
the
manufacturer
or
the
provincial
regulatory
agency.
Contact
the
manufacturer
and
the
provincial
regulatory
agency
in
case
of
a
spill,
and
for
clean
up
of
spills.
In
the
U.
S.
NOTICE
TO
USER:
Seller
makes
no
warranty,
express
or
implied,
of
merchantability,
fitness
or
otherwise
concerning
the
use
of
this
product
other
than
indicated
on
the
label.
User
assumes
all
risks
of
use,
storage,
or
handling
not
in
strict
accordance
with
label
instructions.
In
Canada
NOTICE
TO
BUYER:
Seller's
guarantee
shall
be
limited
to
the
terms
set
out
on
the
label
and,
subject
thereto,
the
buyer
assumes
the
risk
to
persons
or
property
arising
from
the
use
or
handling
of
this
product
and
accepts
the
product
on
that
condition.
SPORODEX
L
is
a
trademark
of
Plant
Products
Co.
Ltd.
Product
Monograph
Pseudozyma
flocculosa
strain
PF
A22
UL
50
9.8.2
Manufacturing
use
product
Manufacturing
Use
Label
NOT
TO
BE
USED
DIRECTLY
FOR
TREATMENT
OF
PESTS
PSEUDOZYMA
FLOCCULOSA
Strain
PF
A22
Technical
Grade
Active
Ingredient
for
Manufacturing
Use
Only.
ACTIVE
INGREDIENT:
Pseudozyma
flocculosa
StrainPF
A22UL
...............
9.
00%
OTHER
INGREDIENTS:
..............................................
91.
00%
TOTAL:
................................................
100.0%
(Contains
a
minimum
of
2
×
10
9
colony
forming
units/
mL)
KEEP
OUT
OF
REACH
OF
CHILDREN
CAUTION
U.
S.
EPA
Registration
No.:
(Pending
as
File
Symbol
69697
R)
U.
S.
EPA
Establishment:
69697
CAN
001
Net
Contents:
(XX)
Manufactured
by:
Plant
Products
Co.
Ltd.
314
Orenda
Road
Brampton,
Ontario
L6T
1G1,
Canada
905
793
7000
Lot
Number:
[XXX]
Date
of
manufacture:
[XXX]
Use
within
3
months
of
the
date
of
manufacture
Product
Monograph
Pseudozyma
flocculosa
strain
PF
A22
UL
51
PRECAUTIONARY
STATEMENTS
HAZARDSTOHUMANS
ANDDOMESTICANIMALS.
CAUTION.
Maycause
sensitization.
Avoid
contact
with
skin,
eyes
or
clothing.
Avoid
breathing
mist.
Wash
thoroughly
with
soap
and
water
after
handling.
PERSONAL
PROTECTIVE
EQUIPMENT
(PPE):
Wear
a
dust/
mist
filtering
respirator
(MSHA/
NIOSH
approval
number
prefix
TC
21C),
or
a
NIOSH
approved
respirator
with
any
N
95,
R
95,
P
95
or
HE
filter
for
biological
products.
Remove
contaminated
clothing
and
follow
manufacturer's
instructions
for
cleaning
/
maintaining
PPE
before
reuse.
If
no
such
instructions
are
available
use
clothing
detergent
and
hot
water
for
cleaning
all
washable
PPE.
Keep
and
wash
PPE
separately
from
other
laundry.
ENVIRONMENTAL
HAZARDS
Do
not
discharge
effluent
containing
the
product
into
lakes,
streams,
ponds,
estuaries,
oceans,
or
other
waters
unless
in
accordance
with
the
requirements
of
the
National
Pollutant
Discharge
Elimination
System
(NDPES)
permit
and
the
permitting
authority
has
been
notified
in
writing
prior
to
discharge.
Do
not
discharge
effluent
containing
this
product
to
sewer
systems
without
previously
notifying
the
local
sewage
treatment
plant
authority.
For
guidance,
contact
your
State
Water
Board
or
Regional
Office
of
the
EPA.
FIRST
AID
If
on
skin
or
clothing
Take
off
contaminated
clothing.
Rinse
skin
immediately
with
plenty
of
water
for
15
–
20
minutes.
Call
a
poison
control
center
or
doctor
for
treatment
advice.
If
inhaled
Move
person
to
fresh
air.
If
person
is
not
breathing,
call
911
or
an
ambulance,
then
give
artificial
respiration,
preferably
by
mouth
to
mouth,
if
possible.
Call
a
poison
control
center
or
doctor
for
treatment
advice.
If
in
eyes
Hold
eye
open
and
rinse
slowly
and
gently
with
water
for
15
20
minutes.
Remove
contact
lenses,
if
present,
after
the
first
5
minutes,
then
continue
rinsing
eye.
Call
a
poison
control
center
or
doctor
for
treatment
advice.
If
swallowed
Call
a
poison
control
center
or
doctor
immediately
for
treatment
advice.
Have
person
sip
a
glass
of
water
if
able
to
swallow.
Do
not
induce
vomiting
unless
told
to
do
so
by
the
poison
control
center
or
doctor.
Do
not
give
anything
by
mouth
to
an
unconscious
person.
Have
container,
label
or
product
name
and
product
registration
number
with
you
when
calling
a
poison
control
center
or
doctor,
or
when
seeking
medical
attention.
DIRECTIONS
FOR
USE
It
is
a
violation
of
Federal
law
to
use
this
product
in
a
manner
inconsistent
with
its
labeling.
Product
Monograph
Pseudozyma
flocculosa
strain
PF
A22
UL
52
FOR
MANUFACTURING
USE
ONLY.
Only
for
formulation
into
end
use
products,
for
use
to
control
plant
diseases
in/
on
agricultural
commodities.
Not
for
direct
treatment
of
pests.
Do
not
use
from
damaged,
punctured
or
unsealed
containers
STORAGE
AND
DISPOSAL
Do
not
contaminate
water,
food
or
feed
by
storage
or
disposal.
Pesticide
Storage:
Store
refrigerated
and
keep
away
from
food
or
feed.
Pesticide
Disposal:
Wastes
resulting
from
the
use
of
this
product
may
be
disposed
of
on
site
or
at
an
approved
waste
disposal
facility.
Container
Disposal:
Triple
rinse
(or
equivalent).
Then
offer
for
recycling
or
reconditioning,
or
puncture
and
dispose
of
in
a
sanitary
landfill,
or
incineration,
or,
if
allowed
by
state
and
local
authorities,
by
burning.
If
burned,
stay
out
of
smoke.
Completely
empty
package
into
application
equipment.
NOTICE
TO
USER:
Seller
makes
no
warranty,
express
or
implied,
of
merchantability,
fitness
or
otherwise
concerning
the
use
of
this
product
other
than
indicated
on
the
label.
User
assumes
all
risks
of
use,
storage,
or
handling
not
in
strict
accordance
with
label
instructions.
Product
Monograph
Pseudozyma
flocculosa
strain
PF
A22
UL
53
Chapter
10
List
of
abbreviations
AUDPC
area
under
disease
pressure
curve
bw
body
weight
CFU
colony
forming
units
DNA
deoxyribonucleic
acid
dw
dry
weight
EPA
Environmental
Protection
Agency
(U.
S.)
FFDCA
Federal
Food
Drug
and
Cosmetic
Act
(U.
S.)
FIFRA
Federal
Insecticide
Fungicide
Rodenticide
Act
(U.
S.)
FQPA
Food
Quality
Protection
Act
(U.
S.)
EP
end
use
product
IPM
integrated
pest
management
KTS
killed
test
substance
LD50
lethal
dose
50%
MA
Martin's
agar
MAS
maximum
average
score
MIS
maximum
irritation
score
MPCA
microbial
pest
control
agent
MRL
maximum
residue
limit
(Canada)
NC
naive
control
PCA
plate
count
agar
PCR
polymerase
chain
reaction
PDA
potato
dextrose
agar
PMRA
Pest
Management
Regulatory
Agency
(Canada)
PPE
personal
protective
equipment
RAMS
random
amplified
microsatellites
REI
restricted
entry
interval
RH
relative
humidity
TGAI
technical
grade
of
the
active
ingredient
TS
test
substance
U.
S.
United
States
of
America
U.
S.
EPA
United
States
Environmental
Protection
Agency
YM
yeast
malt
agar
| epa | 2024-06-07T20:31:43.348371 | regulations | {
"license": "Public Domain",
"url": "https://downloads.regulations.gov/EPA-HQ-OPP-2002-0233-0002/content.txt"
} |
EPA-HQ-OPP-2002-0233-0009 | Supporting & Related Material | "2002-09-13T04:00:00" | null | [2000
0680
&
2001
0304
/
PLG]
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of
Detection
Study
/1
[Pseudozyma
flocculosa
/STF]
Reviewer:
Esther
Seto
,
Date
Jan.
11,
2001
Peer
Review:
Ibrahim
Barsoum,
PhD
Microbial
Pesticides
Branch
Biopesticides
and
Pollution
Prevention
Division
U.
S.
Environmental
Protection
Agency
_______________
STUDY
TYPE:
Sensitivity
of
Detection
of
Sporothrix
flocculosa
for
Toxicity/
Pathogenicity
Testing
in
Rats
TEST
MATERIAL
(PURITY):
Sporothrix
flocculosa
(pure
culture)
8.95
x
10
5
Colony
Forming
Units
(CFU)
per
millilitre
SYNONYMS:
Pseudozyma
flocculosa
[STF],
Stephanoascus
flocculosa
CITATION:
Harrington,
K.
(1997)
Sensitivity
of
Detection
of
Sporothrix
flocculosa
for
Toxicity/
Pathogenicity
Testing
in
Rats.
IIT
Research
Institute
(Chicago,
Illinois).
Laboratory
report
number
L08641,
August
23,
1996
Sept.
18,
1996.
Unpublished.
SPONSOR:
Dr.
Richard
Bélanger.
Université
Laval
Québec,
Canada
G1K7P4
EXECUTIVE
SUMMARY:
The
objective
of
this
study
was
to
determine
a
method
to
reproducibly
recover
Sporothrix
flocculosa
from
the
tissues
of
male
and
female
CD
rats.
A
total
of
four
male
and
four
female
CD
rats
were
used
in
the
study.
Assays
were
carried
out
to
determine
the
levels
of
recovery
from
CD
rat
lung
and
caecum
tissues
inoculated
with
nominal
doses
of
10
2
and
10
4
CFU/
mL
(corresponding
to
measured
doses
of
4.
2
x
10
2
and4.2
x
10
4
CFU/
mL
respectively)
of
the
test
substance.
The
caecum
represented
tissues
in
which
normal
flora
microorganisms
could
compete
with
the
test
substance
for
isolation
on
recovery
media.
The
lung
represented
tissues
which
could
reasonably
be
expected
to
be
devoid
of
competing
organisms.
After
removal
from
the
uninoculated
animals,
lung
and
caecum
tissues
were
blended
and
aliquots
of
the
test
substance
were
added
to
the
tissue
and
peptone
control
samples.
The
suspensions
were
then
either
mixed
and
plated
(pre
blended
samples)
or
re
blended
prior
to
plating
(post
blended
samples)
onto
yeast
malt
agar
(YM),
YM
supplemented
with
chloramphenicol
(YM/
Chl)
or
Martin's
agar
(MA)
for
enumeration.
YM
provided
acceptable
levels
of
recovery
of
the
test
substance
from
the
lung
tissues
of
male
and
female
CD
rats,
whereas
the
selective
properties
of
MA
were
required
to
provide
recovery
from
the
heavily
contaminated
caecum
tissues.
Mechanical
processing
such
as
vortexing
or
blending,
resulted
in
increased
recoveries
(relative
to
the
inoculation
dose).
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The
minimum
detection
limit
for
recovery
of
microorganisms
from
lung
and
caecum
tissues
was
defined
as
30
CFU/
mL.
The
sensitivity
of
detection
(i.
e.
ratio
of
CFU
recovered:
CFU
of
inoculum)
ranged
from
1:
1.
2
(YM
recovery
from
caecum
tissue
inoculated
with
10
2
CFU/
mL)
and
2.
4:
1
(MA
recovery
from
caecum
tissue
inoculated
with
10
4
CFU/
mL).
Based
on
the
results
of
this
study,
YM
will
be
used
as
the
nonselective
recovery
medium
for
rat
tissues
with
the
exception
of
the
stomach
and
intestinal
tract.
MA
will
be
employed
as
the
selective
recovery
medium
for
the
stomach
and
intestinal
tract
in
subsequent
pathogenicity/
toxicity
studies.
This
sensitivity
of
detection
study
for
toxicity
and
pathogenicity
testing
of
Sporothrix
flocculosa
is
classified
as
acceptable.
The
high
standard
deviation
values
and
extremely
high
percentage
recovery
values
for
lung
and
caecum
tissues
at
the
inoculated
dose
of
10
4
CFU/
mL
were
noted
in
the
review.
These
observations,
however,
do
not
impact
on
the
proposal
to
use
MA
as
selective
recovery
medium
for
stomach
and
intestinal
tract
tissues
and
YM
as
recovery
medium
for
all
other
rat
tissues
in
subsequent
toxicity/
pathogenicity
studies.
COMPLIANCE:
Signed
and
dated
GLP
and
Quality
Assurance
statements
were
provided
stating
that
the
study
was
conducted
in
accordance
with
U.
S.
EPA
Good
Laboratory
Practice
Standards
(40
CFR
160).
The
Data
Confidentiality
statement
was
not
dated
or
signed.
I.
MATERIALS
AND
METHODS
A.
MATERIALS:
1.
Test
Material:
Sporothrix
flocculosa
Description:
fungal
culture
Lot/
Batch
#:
produced
Sept.
6,
1996
Purity:
pure
culture
of
Sporothrix
flocculosa
in
yeast
malt
broth
8.9
x
10
5
CFU/
mL
CAS
#:
n/
a
Verification
of
homogeneity
was
conducted
(not
in
this
study
but
in
subsequent
toxicity/
pathogenicity
studies)
by
removing
samples
from
three
locations
(top,
centre,
bottom)
within
a
container
of
the
test
substance
suspension
and
performing
triplicate
plate
counts
using
Yeast
Malt
Agar
(YM).
Sporothrix
flocculosa
batch
number
UK34
35,
was
provided
to
the
test
facility
in
the
form
of
two
petri
dishes
(P1
and
P2)
of
yeast
malt
agar
with
white
mold.
Yeast
malt
broth
was
inoculated
with
a
colony
picked
from
P1
and
incubated
for
7
days
at
room
temperature.
This
culture
was
used
as
the
inoculum
for
the
sensitivity
of
detection
assay.
2.
Vehicle
and/
or
positive
control:
All
dilutions
of
the
test
substance
suspension
were
prepared
in
sterile
ASTM
Type
1
H2
O
(purified
water)
as
the
carrier.
3.
Test
animals:
Species/
Strain:
Male
and
female
Sprague
Dawley
CD
Rats.
Age/
weight
at
dosing:
The
animals
were
41
(males)
and
43
(females)
days
of
age
upon
receipt.
The
body
weight
range
on
the
day
of
the
assay
was
242
262
g
for
the
male
rats
and
162
192
g
for
the
female
rats.
Source:
Charles
River
Breeding
Laboratories
(Portage,
MI)
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Housing:
The
animals
were
housed
up
to
two
per
cage
in
plastic
cages
(10.5"
wide
x
18"
long
x
8"
high)
with
hardwood
chip
bedding.
Diet:
Ceritified
Purina
Rodent
Chow
5002
(PMI
Feeds,
Inc.,
St.
Louis,
MO),
lot
June
12
96
1B
was
provided
ad
libitum,
except
during
an
overnight
fasting
period.
Water:
City
of
Chicago
tap
water
was
provided
ad
libitum.
Fresh
water
was
supplied
twice
weekly.
Environmental
conditions:
Temperature:
Humidity:
Air
changes:
Photoperiod:
22
24
C
38
50%
n/
a
12
hrs
dark/
12
hrs
light
with
fluorescent
lights
Acclimation
period:
The
rats
were
quarantined
from
August
28,
1996
to
September
13,
1996
prior
to
being
released
for
testing.
B.
STUDY
DESIGN
and
METHODS:
1.
Test
Substance
Titre
The
test
substance
was
prepared
in
purified
water,
mixed
by
vortexing
for
at
least
one
minute
and
allowed
to
settle
for
approximately
one
minute.
An
aliquot,
from
the
centre
of
the
suspension,
was
withdrawn
and
plated
on
triplicate
YM
plates.
Four
hours
later,
a
second
aliquot
was
withdrawn
and
plated
on
triplicate
YM
plates.
The
plates
were
incubated
for
112
hours
before
being
examined
for
colonies.
2.
Experimental
Design
and
Test
Procedure
The
detection
of
the
test
substance
on
selective
and
nonselective
bacterial
recovery
media
was
tested
quantitatively.
The
sensitivity
of
detection
in
the
presence
of
lung
and
caecal
tissues,
as
well
as
the
effect
of
blending
on
the
recovery
of
the
test
substance,
was
also
tested.
Four
rats
per
sex
were
sacrificed
by
CO2
asphyxiation
and
the
lungs
and
caecum
were
aspetically
removed
from
each
uninoculated
animal.
Each
tissue
was
placed
in
a
pre
weighed,
sterile
blending
bag
containing
0.
1
%
peptone
(Difco),
blended
manually
or
using
a
Stomacher
blendinger
(Seward
Medical,
London,
England)
and
the
gross
weight
determined
(bag,
peptone
plus
tissue).
Appropriate
dilutions
of
the
test
substance
suspension
were
made
in
order
to
add
a
target
dose
of
2
x
10
2
and2
x
10
4
CFU/
mL
(actual
dose
8.
4
x
10
2
and8.4
x
10
4
)
to
the
blending
bags
containing
an
equal
volume
of
peptone
(control
containing
no
tissue),
blended
lungs
or
blended
caeca
such
that
the
final
concentration
of
the
active
ingredient
was
1
x
10
2
and1
x
10
4
CFU/
mL
(actual
concentration
4.
2
x
10
2
and4.2
x
10
4
CFU/
mL).
The
samples
were
mixed
by
vortexing
and
enumerated
by
removing
a
0.
1
mL
aliquot
and
spreading
on
duplicate
plates
of
Yeast
Malt
Agar
(YM),
YM
supplemented
with
chloramphenicol
(YM/
Chl)
and
Martin's
Agar
(MA)
media.
These
are
referred
to
as
Pre
blended
(Pre)
samples.
The
suspensions
were
then
re
blended
and
re
plated.
These
are
referred
to
as
Post
blended
(Post)
samples.
The
MPCA
titre
in
the
tissues
was
determined
by
colony
counts
after
incubation
at
room
temperature
in
the
dark
for
112
hours.
3.
Calculation
of
Data
Microbial
Enumeration
Mean
microbial
numbers
from
duplicate
plate
counts
for
each
tissue
(Pre
and
Post)
were
obtained
and
expressed
as
CFU/
mL.
The
sensitivity
of
detection
and
the
limit
of
detection
were
expressed
as
factors
of
the
percent
recovery.
II.
RESULTS
AND
DISCUSSION:
A.
Test
Substance
Titre
The
titre
of
the
test
substance
was
determined
to
be
8.9
x
10
5
CFU/
mL
by
plate
count.
The
titre
of
the
dosing
materials
were
determined
to
be
8.
4
x
10
2
and8.4
x
10
4
CFU/
mL.
B.
Sensitivity
of
Detection
of
Test
Substance
Results
of
the
study
showing
the
%
recovery
in
the
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different
sample
suspensions
(generated
from
mean
plate
counts
from
replicate
plates)
are
summarized
in
Table
1.
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Table
1.
Percentage
of
Recovery
of
Sporothrix
flocculosa
in
Test
Sample
Suspensions
nominal
dose
of
10
2
CFU/
mL
(measured
dose
of
4.
2
x
10
2
CFU/
mL)
nominal
dose
of
10
4
CFU/
mL
(measured
dose
of
4.
2
x
10
4
CFU/
mL)
YM
%
Recovery
Pre
blended
a
%
Recovery
Post
blended
b
%
Recovery
Pre
blended
a
%
Recovery
Post
blended
b
Control
c
141.67
(10.10)
150.60
(26.10)
171.43
(16.84)
141.07
(12.63)
Lung
d
170.54
(27.21)
166.37
(24.44)
199.70
(21.92)
382.74
(247.46)
Caecum
d
101.19
(53.75)
80.36
(33.37)
267.26
(219.15)
278.27
(212.62)
YM/
Chl
%
Recovery
Pre
blended
a
%
Recovery
Post
blended
b
%
Recovery
Pre
blended
a
%
Recovery
Post
blended
b
Control
c
167.26
(5.89)
156.55
(10.94)
153.57
(18.52)
152.98
(26.10)
Lung
d
195.54
(19.59)
195.24
(20.11)
288.99
(204.35)
386.01
(242.19)
Caecum
d
171.13
(29.84)
149.40
(8.99)
180.06
(45.81)
266.96
(220.06)
MA
%
Recovery
Pre
blended
a
%
Recovery
Post
blended
b
%
Recovery
Pre
blended
a
%
Recovery
Post
blended
b
Control
c
114.29
(26.94)
189.29
(33.67)
175.00
(3.37)
182.74
(5.89)
Lung
d
211.61
(12.31)
208.63
(7.98)
402.38
(447.10)
568.45
(436.03)
Caecum
d
232.14
(8.80)
194.05
(14.09)
148.81
(49.88)
289.58
(236.25)
a
Pre:
sample
plated
after
vortexing
b
Post:
sample
plated
after
re
blending
c
Two
samples
tested
(mean
and
standard
deviation)
d
Four
samples
tested
(mean
and
standard
deviation)
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Table
2.
Sensitivity
of
Detection
of
P.
flocculosa
*
Media
Tissue
Dose
(CFU/
mL)
Limit
of
Detection
a
Post
Blending
(CFU/
mL)
Sensitivity
of
Detection
b
Post
Blending
YM
Lung
4.2
x
10
2
30
1.2:
1
4.2
x
10
4
30
2.2:
1
Caecum
4.2
x
10
2
53
0.57:
1
4.2
x
10
4
30
1.6:
1
YM/
Chl
Lung
4.2
x
10
2
30
1.4:
1
4.2
x
10
4
30
2.3:
1
Caecum
4.2
x
10
2
30
1.1:
1
4.2
x
10
4
30
1.6:
1
MA
Lung
4.2
x
10
2
30
1.5:
1
4.2
x
10
4
30
3.32:
1
Caecum
4.2
x
10
2
30
1.4:
1
4.2
x
10
4
30
1.7:
1
*
The
study
report
made
an
error
in
calculating
limit
of
detection
and
sensitivity
of
detection.
The
values
in
the
above
table
are
the
corrected
values.
a
The
minimum
limit
of
detection
is
30
CFU/
mL.
The
limit
of
detection
is
based
on
the
sensitivity
of
detection
(i.
e.
if
the
ratio
of
CFU
recovered
:
CFU
dosed
is
>
1,
the
limit
of
detection
is
30;
if
the
ratio
is
<
1,
the
minimum
limit
of
detection
is
divided
by
the
value
of
the
ratio).
b
The
sensitivity
of
detection
is
defined
as:
CFU
recovered
from
post
blended
samples
combined
with
tissue
CFU
recovered
from
pre
blended
samples
combined
with
peptone
only
plated
on
YM.
C.
Pre
vs.
Post
Re
blending
the
samples
did
not
result
in
significant
changes
in
recovery
from
the
lung
at
the
10
2
CFU/
mL
dose
level.
At
the
same
dose
level,
recovery
from
the
post
blended
caecum
samples,
however,
was
lower
than
pre
blended
samples
on
all
three
media.
At
the
10
4
CFU/
mL
dose
level,
blending
resulted
in
increased
recoveries
from
both
the
lung
and
the
caecum
on
all
three
media.
D.
YM
vs.
YM/
Chl
vs.
MA
YM,
YM/
Chl
and
MA
all
provided
acceptable
levels
of
recovery
of
the
test
substance
from
the
lung
and
caecum
of
male
and
female
CD
rats,
with
yields
from
the
caecum
maximum
on
MA
selective
medium.
Based
on
the
results
of
this
study,
YM
will
be
employed
as
the
non
selective
recovery
medium
for
"sterile"
tissues
as
represented
by
the
lung.
MA
selective
medium
will
be
employed
for
recovery
from
non
sterile
tissues
(e.
g.,
stomach
and
intestinal
tract)
as
represented
by
the
caecum.
[2000
0680
&
2001
0304
/
PLG]
~
PROTECTED
~
Sensitivity
of
Detection
Study
/7
[Pseudozyma
flocculosa
/STF]
REVIEWER'S
CONCLUSIONS
This
sensitivity
of
detection
study
is
acceptable.
The
high
standard
deviation
values
and
extremely
high
percentage
recovery
values
for
lung
and
caecum
tissues
at
the
inoculated
dose
of
10
4
CFU/
mL
were
noted
in
the
review.
These
observations,
however,
do
not
impact
on
the
acceptability
of
using
MA
as
selective
recovery
medium
for
stomach
and
intestinal
tract
tissues
and
YM
as
recovery
medium
for
all
other
rat
tissues
in
subsequent
toxicity/
pathogenicity
studies.
Recoveries
were
generally
higher
than
the
amount
dosed.
Mechanical
processing
(e.
g.,
vortexing,
blending)
appeared
to
fragment
mycelial
segments
or
disaggregate
clumped
cells
resulting
in
a
higher
recovery
compared
to
the
amount
dosed.
Re
blending
of
the
samples,
however,
did
not
consistently
increase
or
decrease
recovery.
DEFICIENCIES
The
number
of
air
changes
per
hour
was
not
reported.
This
omission
is
considered
to
have
no
impact
on
the
interpretation
of
the
study
results.
| epa | 2024-06-07T20:31:43.367344 | regulations | {
"license": "Public Domain",
"url": "https://downloads.regulations.gov/EPA-HQ-OPP-2002-0233-0009/content.txt"
} |
EPA-HQ-OPP-2002-0233-0010 | Supporting & Related Material | "2002-09-13T04:00:00" | null | [2000
0680
and
2001
0304
/
PLG]
~
PROTECTED
~
Acute
Pulmonary
Infectivity
and
Toxicity
/
1
[Pseudozyma
flocculosa
/
STF]
DACO
M4.
2.
3
/
USEPA
OPPTS
885.3150
Reviewer:
Esther
Seto
,
Date
January
21,
2002
Peer
Review:
Ibrahim
Barsoum,
PhD
Microbial
Pesticides
Branch
Biopesticides
and
Pollution
Prevention
Division
U.
S.
Environmental
Protection
Agency
_______________
STUDY
TYPE:
Acute
Pulmonary
Toxicity
/
Pathogenicity
PMRA
DATA
CODE
M4.
2.
3
USEPA
OPPTS
885.3150
TEST
MATERIAL
(PURITY):
Sporothrix
flocculosa,
pure
culture
(MPCA)
in
sterile
water
1.15
x
10
8
CFU/
mL
SYNONYMS:
Pseudozyma
flocculosa,
STF,
Stephanoascus
flocculosa
CITATION:
Harrington,
Kelly,
A.
(June
19,
1997).
"Acute
Intratracheal
Infectivity
Testing
of
Sporothrix
flocculosa,
a
Fungal
Pesticide"
IIT
Research
Institute,
Chicago,
Illinois,
USA.
IITRI
Project
No.
L08641,
Study
No.
3
In
Life
Study
Dates:
October
9,
1996
October
14,
1996
(toxicity
range
finding
assay)
and
October
15.
1996
November
5,
1996
(infectivity
assay).
Unpublished.
SPONSOR:
Université
Laval
Québec,
Canada
G1K
7P4
EXECUTIVE
SUMMARY:
In
an
acute
pulmonary
toxicity/
infectivity
study,
groups
of
young
adult
CD
rats
(4/
sex/
scheduled
sacrifice
date)
were
exposed
by
the
intratracheal
route
to
an
undiluted
suspension
of
Sporothrix
flocculosa
(TS)
at
a
dose
of
3.
2
x
10
7
cfu/
animal
(in
0.
1
mL).
Animals
were
then
observed
for
up
to
14
days.
An
equal
number
of
young
adult
CD
rats
were
similarly
injected
with
heat
killed
test
substance
(KTS).
An
undosed
naive
control
(NC)
group
consisting
of
4
rats/
sex
was
also
included
in
the
study.
Cage
side
observations
for
clinical
symptoms
was
performed
daily
and
animal
body
weights
and
food
consumption
were
monitored.
Designated
test
animals
from
the
TS
and
KTS
groups
were
sacrificed
on
days
0,
7
and
14
and
gross
necropsies
were
performed.
During
the
course
of
the
study,
5
TS
dosed
and
10
KTS
dosed
animals
died
prior
to
their
scheduled
sacrifice
dates.
These
animals
were
also
necropsied.
The
NC
group
of
animals
was
sacrificed
and
necropsied
at
the
end
of
the
14
day
study.
Infectivity
and
clearance
were
assessed
by
quantitatively
recovering
the
MPCA
from
the
blood,
lungs
and
lymph
nodes,
spleen,
kidneys,
liver,
heart,
stomach
and
small
intestine,
caecum
and
brain.
Laboured
respiration
was
observed
in
3/
12
TS
dosed
male
rats,
1/
12
TS
dosed
female
rats,
1/
12
KTSdosed
male
rats
and
4/
12
KTS
dosed
female
rats.
The
posture
of
one
female
TS
dosed
animal
was
[2000
0680
and
2001
0304
/
PLG]
~
PROTECTED
~
Acute
Pulmonary
Infectivity
and
Toxicity
/
2
[Pseudozyma
flocculosa
/
STF]
DACO
M4.
2.
3
/
USEPA
OPPTS
885.3150
hunched.
Rough
hair
coat
was
observed
in
3/
12
TS
dosed
male
rats,
1/
12
KTS
dosed
male
rats
and
4/
8
KTS
dosed
female
rats.
One
rat
from
each
of
the
male
TS
dosed,
male
KTS
dosed
and
female
KTS
dosed
groups
had
ocular
discharge.
Nasal
discharge
was
noted
in
2/
12
male
TS
dosed
rats,
1/
12
KTS
dosed
rat
and
2/
12
female
KTS
dosed
rats.
One
male
TS
dosed
rat
appeared
lethargic
on
day
4.
The
presence
or
absence
of
clinical
symptoms
were
not
indicative
of
spontaneous
deaths.
Due
to
the
large
number
of
spontaneous
deaths
(3/
12
male
TS
dosed
rats,
6/
12
male
KTS
dosed
rats,
2/
12
female
TS
dosed
rats
and
4/
12
female
KTS
dosed
rats)
and
a
number
of
missed
data
collections,
data
for
evaluating
body
weights,
food
consumption
and
relative
organ
weight
were
limited.
At
the
end
of
the
14day
long
study,
administration
of
S.
flocculosa
did
not
have
a
statistically
significant
effect
on
body
weight.
Analysis
of
daily
food
consumption
and
relative
organ
weights
was
skewed
as
it
was
not
determined
or
did
not
include
animals
that
died
prior
to
their
scheduled
sacrifice
dates.
At
necropsy,
lesions
and
enlargement
of
the
lung
were
observed
in
6/
12
male
TS
dosed
rats,
5/
12
male
KTS
dosed
rats,
4/
12
female
TS
dosed
rats
and
6/
12
female
KTS
dosed
rats.
Confluent
dark
areas
were
seen
in
the
kidneys
of
one
male
TS
dosed
rat.
Lesions
and
enlargement
of
the
spleen
were
noted
in
1/
12
male
TS
and
KTS
dosed
rats
and
2/
12
female
KTS
dosed
rats.
Liver
lesions
were
observed
in
one
animal
from
each
of
the
male
TS
dosed,
male
KTS
dosed
and
female
KTS
dosed
groups.
These
necropsy
findings
were
considered
consistent
with
the
method
of
dosing
and
the
body's
normal
immunological
response
to
a
foreign
substance.
Sporothrix
flocculosa
was
detected
in
the
lungs
and
lymph
nodes
and
the
stomach
and
small
intestine
of
TS
dosed
animals
only.
Counts
in
these
tissues
were
below
the
limit
of
detection
by
day
7.
Based
on
this
study,
S.
flocculosa
is
toxic,
but
not
infective
or
pathogenic,
at
the
dose
administered
when
introduced
by
the
intratracheal
route
to
male
and
female
CD
rats.
This
acute
pulmonary
study,
however,
is
classified
as
UNACCEPTABLE
due
to
major
deficiencies
in
the
collected
data
and
a
possible
dosing
error,
as
indicated
by
the
presence
of
the
MPCA
in
the
stomach
and
small
intestines
on
the
day
of
dosing.
A
subsequent
range
finding
acute
pulmonary
toxicity
study
was
conducted
and
reviewed.
COMPLIANCE:
Signed
and
dated
GLP
compliance
and
Quality
Assurance
statements
were
provided.
An
unsigned
Data
Confidentiality
statement
was
included.
I.
MATERIALS
AND
METHODS
A.
MATERIALS:
1.
Test
Material:
Sporothrix
flocculosa
(produced
by
test
facility)
Description:
MPCA
Lot/
Batch
#:
UK34
35
Purity:
toxicity
range
finding
asay:
7.
5
x
10
8
cells/
mL
or
1.
15
x
10
8
cfu/
mL
infecitivity
assay:
6.
0
x
10
8
cells/
mL
or
3.
2
x
10
8
cfu/
mL
CAS
#:
n/
a
[2000
0680
and
2001
0304
/
PLG]
~
PROTECTED
~
Acute
Pulmonary
Infectivity
and
Toxicity
/
3
[Pseudozyma
flocculosa
/
STF]
DACO
M4.
2.
3
/
USEPA
OPPTS
885.3150
Test
substance
homogeneity
was
determined
by
withdrawing
aliquots
from
three
locations
(top,
centre
and
bottom)
of
a
10
mL
tube
containing
test
substance
in
ASTM
type
1
water.
Samples
from
the
three
locations
were
plated
in
triplicate
on
YM
plates.
Colonies
were
counted
after
incubation
for
three
days
at
25
C.
The
average
plate
count
of
the
triplicate
samples
taken
from
each
location
were
comparable,
indicating
that
the
test
substance
was
homogeneous
throughout
the
volume
of
the
tube.
2.
Sample
Preparation:
Sporothrix
flocculosa
(batch
number
UK34
45)
was
provided
to
the
test
facility
in
the
form
of
two
petri
dishes
(P1
and
P2)
of
yeast
malt
agar
with
white
mould.
IITRI
then
inoculated
two
malt
agar
plates
(P3
and
P4)
with
a
colony
from
P1.
One
week
prior
to
dosing
in
the
toxicity
range
finding
component
of
the
study,
300
mL
of
yeast
malt
broth
was
inoculated
with
test
substance
from
P4
and
incubated
at
room
temperature
for
seven
days.
On
the
day
of
dosing,
the
broth
culture
was
centrifuged
and
the
pellet
was
resuspended
in
5
mL
of
ASTM
type
1
water.
The
titre
of
the
resuspended
solution
was
determined
to
be
7.
5
x
10
8
cells/
mL
by
hemacytometer
count
(corresponding
to
1.
15
x
10
8
cfu/
mL
as
determined
by
plate
count).
This
solution
was
used
undiluted
for
dosing.
One
week
before
the
start
of
the
infectivity
assay,
300
mL
of
yeast
malt
broth
was
inoculated
with
test
substance
from
P4
and
incubated
at
room
temperature
for
seven
days.
On
the
day
of
dosing,
the
broth
culture
was
centrifuged
and
resuspended
in
7
mL
of
ASTM
type
1
water.
The
titre
of
the
resuspended
solution
was
determined
to
be
6.
0
x
10
8
cells/
mL
by
hemacytometer
count.
Half
of
the
solution
was
heat
treated
for
20
minutes
at
approximately
82
C
to
render
the
active
ingredient
non
viable
and
was
used
as
KTS
(killed
test
substance).
The
rest
of
the
solution
was
used
as
TS
(test
substance).
Both
KTS
and
TS
were
plated
to
verify
titre
and
inactivation,
respectively.
The
titre
of
the
TS
solution
was
3.2
x
10
8
cfu/
mL
and
the
titre
of
the
KTS
solution
was
0
cfu/
mL.
3.
Test
animals:
Species
/
Strain:
CD
Rat
Age/
weight
at
dosing:
approximately
6
weeks
of
age
males:
222.93
274.76
g
females:
160.07
214.38
g
Source:
Charles
River
Laboratories
Portage,
MI
Housing:
The
animals
were
housed
2/
cage
in
polypropylene
cages
with
hardwood
chip
bedding.
Animal
rooms
and
cages
were
cleaned
and
sanitized
prior
to
initiation
of
the
study
and
cages
were
cleaned
twice
weekly
thereafter.
Control
group
animals
(naive
control
and
killed
test
substance
dosed
groups)
were
housed
in
one
room
while
test
substance
dosed
groups
were
housed
in
a
second
room.
Diet:
Certified
Purina
Rodent
Chow
5002
(PMI
Feeds
Inc.,
St.
Louis,
MO)
was
provided
ad
libitum.
Water:
City
of
Chicago
tap
water
was
provided
ad
libitum.
Environmental
conditions:
Temperature:
Humidity:
Air
changes:
Photoperiod:
18
25
C
27
70
%
Not
reported
12
hrs
dark
/
12
hrs
light
Acclimation
period:
One
week
acclimation
period
for
animals
used
in
toxicity
range
finding
assay.
Two
week
acclimation
period
for
animals
used
in
infectivity
assay.
[2000
0680
and
2001
0304
/
PLG]
~
PROTECTED
~
Acute
Pulmonary
Infectivity
and
Toxicity
/
4
[Pseudozyma
flocculosa
/
STF]
DACO
M4.
2.
3
/
USEPA
OPPTS
885.3150
B.
STUDY
DESIGN
and
METHODS:
1.
In
life
dates
October
9,
1996
October
14,
1996
(toxicity
range
finding
assay)
October
15.
1996
November
5,
1996
(infectivity
assay)
2.
Animal
assignment
and
treatment
After
one
week
of
quarantine,
three
rats
per
sex
were
selected
randomly,
weighed
and
used
in
the
5
day
preliminary
range
finding
toxicity
assay.
Rats
were
anesthetized
with
ether
and
dosed
intratracheally
with
0.
1
mL
of
the
test
substance,
containing
1.
15
x
10
7
cfu,
prepared
for
the
toxicity
range
finding
assay.
The
rats
were
observed
for
five
days
post
dosing.
For
the
infectivity
assay,
the
remaining
animals
were
weighed
one
week
later
and
assigned
to
treatment
groups
such
that
no
animal's
body
weight
varied
from
the
group
mean
body
weight
by
more
than
20%.
Treatment
groups
included
TS
dosed
rats,
KTS
dosed
rats
and
a
naive
control
(NC)
group
of
rats.
The
number
of
animals
and
the
sacrifice
time
for
each
of
the
test
groups
is
shown
in
Table
1.
The
rats
were
anesthetized
with
ether,
dosed
intratracheally
and
observed
for
14
days.
TABLE
1.
Treatment,
mortality/
animals
treated
Group
Number
Treatment
Scheduled
Sacrifice
Mortality
(#
dead/
total)
Males
Females
Combined
1
TS
b
0
0/
4
0/
4
0/
8
2
KTS
c
0
0/
4
0/
4
0/
8
3
TS
b
7
3/
4
a
2/
4
5/
8
4
KTS
c
7
4/
4
4/
4
8/
8
5
TS
b
14
0/
4
a
0/
4
0/
8
6
KTS
c
14
2/
4
0/
4
2/
8
7
NC
d
14
0/
4
0/
4
0/
8
a
one
male
rat
in
the
group
was
inadvertently
dosed
twice
b
dosed
with
0.
1
mL
of
TS
containing
3.
2
x
10
7
cfu
c
dosed
with
0.1
mL
of
KTS
containing
the
equivalent
of
3.2
x
10
7
cfu
of
heat
killed
active
ingredient
d
naive
control
group
3.
Body
Weight
Animal
body
weights
were
determined
upon
receipt,
prior
to
randomization,
at
the
time
of
test
substance
dosing
(day
0)
and
weekly
thereafter.
4.
Food
Consumption
Food
consumption
was
monitored
when
food
was
replenished.
Average
daily
food
consumption
per
rat
was
calculated.
5.
Clinical
Observations
Cageside
observations
were
made
daily
during
the
toxicity
range
finding
and
infectivity
assays.
6.
Necropsies
Necropsies
were
performed
upon
death
or
at
scheduled
sacrifice
times.
Organ
weights
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flocculosa
/
STF]
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/
USEPA
OPPTS
885.3150
(relative
to
body
weights)
were
recorded.
Gross
observations
of
external
features
and
internal
organs
and
cavities
of
each
animal
were
made.
7.
Microbial
Enumeration
Samples
of
blood
(from
surviving
animals
only),
brain,
caecum,
kidney,
liver,
heart,
lung
and
lymph
nodes,
spleen,
stomach
and
small
intestines
were
aseptically
removed
and
placed
in
sterile
blending
bags
containing
0.
1%
peptone.
The
tissues
were
blended
and
aliquots
were
serially
diluted
in
0.
1%
peptone
and
plated
onto
YM
or
MA
(see
study
for
determination
sensitivity
of
detection).
The
plates
were
incubated
for
at
least
72
hours
at
approximately
25
C.
Counts
were
reported
as
viable
cfu/
mL
of
blood
or
cfu/
gram
of
tissue.
8.
Statistics
Mean
body
weights,
cumulative
body
weight
gains,
average
daily
food
consumption
and
organ
weights
(as
a
percentage
of
total
body
weight)
were
calculated
for
each
combination
of
sex
and
treatment
along
with
corresponding
standard
deviations.
Treatment
groups
were
compared
using
analysis
of
variance
(ANOVA)
followed,
where
appropriate,
by
Dunnett's
test.
A
p
0.05
was
considered
significant
for
all
statistical
analyses.
II.
RESULTS
AND
DISCUSSION:
A.
Mortality
None
of
the
three
male
and
three
female
rats
dosed
in
the
range
finding
assay
died
during
the
5
day
observation
period.
A
total
of
15
rats
(3/
8
male
TS
dosed
rats,
6/
8
male
KTS
dosed
rats,
2/
8
female
TS
dosed
rats
and
4/
8
female
KTS
dosed
rats)
died
on
days
2
and
3
of
the
infectivity
assay.
These
mortalities
are
summarized
in
Table
1.
The
male
rat
in
group
3
that
was
inadvertently
dosed
twice
was
one
of
the
rats
that
died.
The
LC50
of
S.
flocculosa
formalesis>
3.2
x
10
7
cfu/
animal.
for
females
is
>
3.
2
x
10
7
cfu/
animal
combined
is
>
3.
2
x
10
7
cfu/
animal.
Thehigh
spontaneousdeath
ratein
TS
and
KTS
dosedratsmay
havebeenpartiallydueto
thelargesize
of
S.
flocculosa.
The
higher
death
rate
of
KTS
dosed
versus
TS
dosed
rats
may
have
been
due
to
toxins
which
were
activated
by
the
autoclaving
step
used
to
produce
the
KTS.
Regardless
of
the
cause
of
deaths,
the
large
number
of
deaths
made
it
difficult
to
properly
assess
the
data
collected
in
this
study.
B.
Clinical
Observations
During
the
toxicity
range
finding
assay,
one
female
exhibited
laboured
respiration
on
the
day
of
dosing.
No
other
adverse
clinical
signs
were
observed
in
the
other
animals
used
for
the
toxicity
range
finding
assay.
Results
of
clinical
observations
of
the
test
animals
over
the
course
of
the
14
day
infectivity
assay
are
summarized
in
Table2.
Theseresultsincludethoseofanimalswhich
weresacrificed
on
day0(
4
animals/
sex/
treatment
group).
TABLE
2.
Clinical
Observations
TS
(12
animals
/
sex)
KTS
(12
animals
/
sex)
NC
(12
animals
/
sex)
Observation
M
F
M
F
M
F
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/
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M4.
2.
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/
USEPA
OPPTS
885.3150
founddead3
2
6
40
0
labouredrespiration3
1
1
40
0
hunchedposture0
1
0
00
0
roughhaircoat3
0
1
40
0
oculardischarge1
0
1
10
0
nasaldischarge2
0
1
20
0
lethargic1
0
0
00
0
no
observed
signs
7
11
11
7
4
4
Rough
hair
coat
and
laboured
respiration
was
first
observed
between
days
0
2
and
persisted
in
some
animals
up
until
day
11.
The
onset
of
hunched
posture,
nasal
discharge,
ocular
discharge
and
lethargy
occurred
between
days
2
4
and
persisted
for
only
one
to
two
days.
Of
the
15
rats
that
died,
only
6
exhibited
adverse
clinical
symptoms
prior
to
their
death,
and
not
all
of
the
rats
displaying
symptoms
died.
C.
Body
Weight
The
body
weights
of
a
number
of
animals
that
died
and
the
body
weights
of
whole
groups
of
animals
on
particular
days
were
inadvertently
not
measured.
These
omissions
in
body
weight
measurements
were
considered
a
major
deficiency.
Based
on
the
available
data,
mean
body
weights
and
body
weight
gains
are
summarized
in
Tables
3
and
4.
Analysis
of
the
limited
data
indicated
no
statistically
significant
differences
in
mean
body
weight
or
mean
body
weight
gain
between
groups
at
the
end
of
the
14day
observation
period.
Individual
body
weight
data
revealed
that
all
animals
that
died
prior
to
their
scheduled
sacrifice
dates
had
lost
a
significant
amount
of
weight
(35.
74
63.
05
g
for
TS
dosed
rats;
30.
09
50.
26
g
for
KTS
dosed
rats)
within
two
to
three
days
after
dosing.
Two
female
rats
in
the
NC
group
were
deprived
of
water
during
the
second
week
of
the
study
leading
to
a
loss
in
weight.
The
duration
of
time
for
which
these
animals
were
deprived
was
not
available.
TABLE
3.
Mean
Body
Weights
Body
Weight
(g)
Treatment
Group
Sex
Parameter
Day
0
Day
2
Day
3
Day
7
Day
14
TS
M
Mean
SD
N
261.63
12.79
12
200.62
7.67
2
191.21
1
267.1
1
317.96
48.17
4
KTS
M
Mean
SD
N
253.73
11.52
12
210.81
15.49
5
297.45
17.65
2
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0680
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0304
/
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Pulmonary
Infectivity
and
Toxicity
/
7
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flocculosa
/
STF]
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2.
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/
USEPA
OPPTS
885.3150
NC
M
Mean
SD
N
254.20
13.88
4
338.24
27.08
4
TS
F
Mean
SD
N
192.39
10.80
12
145.75
1
242.71
32.94
2
233.01
9.74
4
KTS
F
Mean
SD
N
192.13
13.74
12
157.03
2.01
2
225.32
21.93
4
NC
F
Mean
SD
N
191.33
9.72
4
190.96
50.39
4
data
not
available
due
to
spontaneous
deaths,
death
of
all
animals
in
group
or
missed
body
weight
measurements
TABLE
4.
Mean
Body
Weight
Gains
Total
Gain
(g)
Treatment
Group
Sex
Parameter
Day
0
14
TS
M
Mean
SD
N
68.13
29.52
4
KTS
M
Mean
SD
N
56.88
23.01
2
NC
M
Mean
SD
N
84.04
17.16
4
TS
F
Mean
SD
N
41.35
2.86
4
KTS
F
Mean
SD
N
30.18
15.27
4
NC
F
Mean
SD
N
0.38
53.19
4
D.
Food
Consumption
Food
consumption
data
are
presented
in
Table
5.
Food
consumption
was
not
determined
for
animals
which
died
prior
to
their
scheduled
sacrifice
dates.
Analysis
of
the
limited
data
indicated
no
statistically
significant
differences
between
treatment
groups.
TABLE
5.
Average
Daily
Food
Consumption
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/
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2.
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/
USEPA
OPPTS
885.3150
Treatment
Group
Sex
Parameter
Average
Daily
Consumption
(g)
TS
M
Mean
SD
N
23.0
4.6
5
KTS
M
Mean
SD
N
20.6
1.6
4
NC
M
Mean
SD
N
25.9
1.6
4
TABLE
5.
Average
Daily
Food
Consumption
contd.
Treatment
Group
Sex
Parameter
Average
Daily
Consumption
(g)
TS
F
Mean
SD
N
16.3
2.1
6
KTS
F
Mean
SD
N
15.1
3.3
4
NC
F
Mean
SD
N
15.6
3.6
4
E.
Necropsy
Results
Lung
lesions
were
observed
in
TS
and
KTS
dosed
animals
and
in
both
animals
that
died
prior
to
their
scheduled
sacrifice
dates
and
those
that
survived
until
sacrifice.
Other
lesions
in
the
spleen,
liver
and
kidney
were
observed
primarily
in
the
animals
that
died.
Three
of
the
15
animals
that
died
exhibited
no
gross
lesions.
No
lesions
were
found
in
any
of
the
NC
animals
or
in
any
of
the
4/
sex
TS
and
KTS
dosed
animals
sacrificed
post
dosing
on
day
0.
Necropsy
findings
are
summarized
in
Table
6.
TABLE
6.
Necropsy
Findings
TS(
12
animals/
sex)
KTS(
12
animals/
sex)
NC(4
animals/
sex)
Organ
observation
M
FMFMF
Kidneys
confluent
dark
1–––––
Liver
confluent
dark
diffuse
dark
red
foci,
diffuse
dark
red
1
–
–
–
–
–
–
–
1
–
1
–
–
–
–
–
–
–
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0680
and
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0304
/
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/
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flocculosa
/
STF]
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2.
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Lung
cyst
diffuse
red
lesion
enlarged
focus,
multiple
dark
red
granular,
diffuse
dark
red
mass
pigmentation,
mottled
single
red
lesion
focus,
multiple
diffuse
1
1
2
–
–
1
–
1
–
–
1
1
–
–
2
–
–
–
1
–
1
–
1
–
1
–
1
2
–
3
–
1
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
Spleen
confluent
dark
enlarged
nodule,
multiple
1
–
–
–
–
–
–
1
–
–
1
1
–
–
–
–
–
–
No
gross
lesions
78
7
4
44
F.
Organ
Weights
The
effectsoftestsubstance
onrelative
organweightsaresummarizedinTables7
and
8.
Relative
organ
weights
were
not
calculated
for
1
KTS
dosed
male,
1
TS
dosed
female
and
2
KTSdosed
females
were
not
calculated
since
their
body
weights
were
inadvertently
not
taken
at
the
time
of
their
spontaneous
deaths.
Statistical
analysis
was
conducted
only
on
Day
14
data
as
relative
organ
weights
of
NC
rats
were
only
available
for
Day
14.
The
relative
weights
of
the
lungs
and
lymph
nodes
of
TS
and
KTS
dosed
male
rats
and
KTS
dosed
female
rats
were
significantly
increased
compared
to
their
NC
counterparts.
The
KTSdosed
rats
also
had
significantly
increased
relative
spleen
weights
as
compared
to
NC
animals.
TABLE
7.
Relative
Organ
Weights
of
Male
Rats
Relative
Organ
Weight
(%)
a
Treatment
Group
Day
Parameter
Lungs
and
Lymph
Nodes
Spleen
Kidneys
Liver
Heart
Stomach
and
Small
Intestine
Caecum
Brain
TS
0
Mean
SD
N
0.588
0.0399
4
0.234
0.0231
4
1.041
0.0432
4
4.781
0.1789
4
0.497
0.0995
4
5.812
1.0454
4
2.246
0.2904
4
0.788
0.0495
4
KTS
0
Mean
SD
N
0.783
0.1431
4
0.268
0.0303
4
1.019
0.0695
4
5.217
0.1936
4
0.448
0.0297
4
5.954
1.4792
4
2.188
0.3856
4
0.768
0.0304
4
TS
2
Mean
SD
N
0.3288
0.3103
2
0.313
0.0568
2
1.298
0.1407
2
6.476
0.0102
2
0.555
0.2100
2
5.835
1.7558
2
0.861
0.0411
2
1.004
0.0183
2
KTS
b
2
Mean
SD
N
2.978
0.2469
5
0.323
0.0434
5
1.252
0.1407
5
6.085
0.6457
5
0.414
0.0360
5
3.136
1.3865
5
1.128
0.2886
5
0.910
0.0263
5
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0680
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0304
/
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~
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flocculosa
/
STF]
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/
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885.3150
TS
3
Mean
SD
N
3.962
–
1
0.538
–
1
1.311
–
1
7.137
–
1
0.467
–
1
1.545
–
1
0.882
–
1
0.966
–
1
TS
7
Mean
SD
N
1.201
–
1
0.352
–
1
0.999
–
1
4.444
–
1
0.638
–
1
5.560
–
1
1.962
–
1
0.776
–
1
TS
14
Mean
SD
N
1.378*
0.4414
4
0.281
0.0324
4
0.903
0.0534
4
4.407
0.2441
4
0.396
0.0406
4
2.783
0.7500
4
2.637
0.4895
4
0.646
0.1204
4
KTS
14
Mean
SD
N
1.524*
0.5578
2
0.617*
0.3987
2
0.994
0.0628
2
4.678
0.7775
2
0.364
0.0047
2
3.544
0.4449
2
2.333
0.1315
2
0.698
0.0024
2
NC
14
Mean
SD
N
0.738
0.2227
4
0.199
0.0172
4
0.920
0.0448
4
4.778
0.3979
4
0.401
0.0345
4
3.339
0.1582
4
2.411
0.4032
4
0.578
0.0543
4
a
Relative
organ
weight
=
[absolute
organ
weight
(g)
/
body
weight
(g)]
x
100%
b
Mean
and
standard
deviation
calculated
for
only
5/
6
rats
which
died
on
day
2.
The
body
weight
of
the
6
th
animal
was
inadvertently
not
taken.
*statistically
significant
from
NC,
p
0.
05
(ANOVA
and
Dunnett's
test
performed
on
Day
14
data
only)
TABLE
8.
Relative
Organ
Weights
of
Female
Rats
Relative
Organ
Weight
(%)
a
Treatment
Group
Day
Parameter
Lungs
and
Lymph
Nodes
Spleen
Kidneys
Liver
Heart
Stomach
and
Small
Intestine
Caecum
Brain
TS
0
Mean
SD
N
0.686
0.0858
4
0.228
0.0329
4
0.960
0.0438
4
0.4271
0.5159
4
0.485
0.0486
4
5.218
0.5456
4
2.309
0.1835
4
0.994
0.0427
4
KTS
0
Mean
SD
N
0.854
0.0835
4
0.242
0.0339
4
0.870
0.0834
4
4.355
0.3931
4
0.416
0.0174
4
4.588
1.3688
4
2.293
0.4117
4
0.932
0.0908
4
TS
2
Mean
SD
N
3.862
–
1
0.297
–
1
1.260
–
1
5.777
–
1
0.428
–
1
3.683
–
1
1.164
–
1
1.215
–
1
KTS
2
Mean
SD
N
3.207
0.3977
2
0.274
0.0094
2
1.250
0.0822
2
5.959
0.1208
2
0.425
0.0355
2
4.916
3.2068
2
0.896
0.1083
2
1.154
0.0613
2
TS
3
Mean
SD
N
ND
b
ND
1
ND
ND
1
ND
ND
1
ND
ND
1
ND
ND
1
ND
ND
1
ND
ND
1
ND
ND
1
KTS
3
Mean
SD
N
ND
ND
2
ND
ND
2
ND
ND
2
ND
ND
2
ND
ND
2
ND
ND
2
ND
ND
2
ND
ND
2
[2000
0680
and
2001
0304
/
PLG]
~
PROTECTED
~
Acute
Pulmonary
Infectivity
and
Toxicity
/
11
[Pseudozyma
flocculosa
/
STF]
DACO
M4.
2.
3
/
USEPA
OPPTS
885.3150
TS
7
Mean
SD
N
1.247
0.2855
2
0.312
0.0065
2
0.825
0.2751
2
3.763
1.1773
2
0.380
0.0169
2
4.850
1.4324
2
1.661
0.0163
2
0.795
0.0829
2
TS
14
Mean
SD
N
1.271
0.1771
4
0.360
0.0802
4
0.896
0.0570
4
4.197
0.2994
4
0.441
0.1002
4
3.203
0.1360
4
2.345
0.2067
4
0.799
0.0947
4
KTS
14
Mean
SD
N
1.645*
0.4418
4
0.761*
0.3774
4
0.976
0.1646
4
4.865
0.7747
4
0.415
0.0561
4
3.284
0.4018
4
2.265
0.6521
4
0.832
0.1178
4
NC
14
Mean
SD
N
0.891
0.1105
4
0.218
0.0296
4
1.127
0.1010
4
4.370
0.3211
4
0.449
0.0684
4
5.175
2.2565
4
1.739
0.5391
4
1.006
0.2046
4
a
Relative
organ
weight
=
[absolute
organ
weight
(g)
/
body
weight
(g)]
x
100%
b
ND
not
determined;
body
weight
not
determined
*statistically
significant
from
NC,
p
0.
05
(ANOVA
and
Dunnett's
test
performed
on
Day
14
data
only)
G.
Microbial
Enumeration
Enumeration
of
the
test
substance
from
various
organs
and
blood
is
summarized
in
Tables
9
and
10.
No
test
substance
was
recovered
from
any
NC
or
KTS
dosed
animals.
Viable
S.
flocculosa
was
recovered
only
from
the
lungs
and
lymph
nodes
(day
0)
and
the
stomach
and
small
intestines
(day
0
and
day
2)
from
TS
dosed
animals.
TABLE
9.
Recovery
of
Sporothrix
flocculosa
from
Selected
Tissues
and
Blood
of
Male
Rats
Log
[(
cfu/
g
of
tissue)
+
1]
or
Log
[(
cfu/
mL
of
blood)
+
1]
Group
Day
Parameter
Blood
Lung
&
Lymph
Nodes
Spleen
Kidneys
Liver
Heart
Stomach
&
Small
Intestine
Caecum
Brain
TS
0
Mean
SD
GeoMn
b
N
BDL
a
BDL
BDL
4
7.239
0.322
1.73
x
10
7
4
BDL
BDL
BDL
4
BDL
BDL
BDL
4
BDL
BDL
BDL
4
BDL
BDL
BDL
4
4.320
0.667
2.09
x
10
4
4
BDL
BDL
BDL
4
BDL
BDL
BDL
4
KTS
0
Mean
SD
GeoMn
N
BDL
BDL
BDL
4
BDL
BDL
BDL
4
BDL
BDL
BDL
4
BDL
BDL
BDL
4
BDL
BDL
BDL
4
BDL
BDL
BDL
4
BDL
BDL
BDL
4
BDL
BDL
BDL
4
BDL
BDL
BDL
4
TS
2
Mean
SD
GeoMn
N
ND
c
ND
ND
2
BDL
BDL
BDL
2
BDL
BDL
BDL
2
BDL
BDL
BDL
2
BDL
BDL
BDL
2
BDL
BDL
BDL
2
1.791
2.533
6.18
x
10
1
2
BDL
BDL
BDL
2
BDL
BDL
BDL
2
KTS
2
Mean
SD
GeoMn
N
ND
ND
ND
6
BDL
BDL
BDL
6
BDL
BDL
BDL
6
BDL
BDL
BDL
6
BDL
BDL
BDL
6
BDL
BDL
BDL
6
BDL
BDL
BDL
6
BDL
BDL
BDL
6
BDL
BDL
BDL
6
[2000
0680
and
2001
0304
/
PLG]
~
PROTECTED
~
Acute
Pulmonary
Infectivity
and
Toxicity
/
12
[Pseudozyma
flocculosa
/
STF]
DACO
M4.
2.
3
/
USEPA
OPPTS
885.3150
TS
3
Mean
SD
ND
ND
ND
1
BDL
1
BDL
1
BDL
1
BDL
1
BDL
1
BDL
1
BDL
1
BDL
GeoMn
N
1
TS
7
Mean
SD
BDL
1
BDL
1
BDL
1
BDL
1
BDL
1
BDL
1
BDL
1
BDL
1
BDL
GeoMn
N
1
TS
14
Mean
SD
GeoMn
N
BDL
BDL
BDL
4
BDL
BDL
BDL
4
BDL
BDL
BDL
4
BDL
BDL
BDL
4
BDL
BDL
BDL
4
BDL
BDL
BDL
4
BDL
BDL
BDL
4
BDL
BDL
BDL
4
BDL
BDL
BDL
4
KTS
14
Mean
SD
GeoMn
N
BDL
BDL
BDL
2
BDL
BDL
BDL
2
BDL
BDL
BDL
2
BDL
BDL
BDL
2
BDL
BDL
BDL
2
BDL
BDL
BDL
2
BDL
BDL
BDL
2
BDL
BDL
BDL
2
BDL
BDL
BDL
2
NC
14
Mean
SD
GeoMn
N
BDL
BDL
BDL
4
BDL
BDL
BDL
4
BDL
BDL
BDL
4
BDL
BDL
BDL
4
BDL
BDL
BDL
4
BDL
BDL
BDL
4
BDL
BDL
BDL
4
BDL
BDL
BDL
4
BDL
BDL
BDL
4
a
BDL
below
detection
limit
b
GeoMn
geometric
mean
of
cfu/
tissue
or
cfu/
mL
c
ND
not
done
TABLE
10.
Recovery
of
Sporothrix
flocculosa
from
Selected
Tissues
and
Blood
of
Female
Rats
Log
[(
cfu/
g
of
tissue)
+
1]
or
Log
[(
cfu/
mL
of
blood)
+
1]
Group
Day
Parameter
Blood
Lung
&
Lymph
Nodes
Spleen
Kidneys
Liver
Heart
Stomach
&
Small
Intestine
Caecum
Brain
TS
0
Mean
SD
GeoMn
b
N
BDL
a
BDL
BDL
4
7.014
0.354
1.03
x
10
7
4
BDL
BDL
BDL
4
BDL
BDL
BDL
4
BDL
BDL
BDL
4
BDL
BDL
BDL
4
3.867
0.553
7.35
x
10
3
4
BDL
BDL
BDL
4
BDL
BDL
BDL
4
KTS
0
Mean
SD
GeoMn
N
BDL
BDL
BDL
4
BDL
BDL
BDL
4
BDL
BDL
BDL
4
BDL
BDL
BDL
4
BDL
BDL
BDL
4
BDL
BDL
BDL
4
BDL
BDL
BDL
4
BDL
BDL
BDL
4
BDL
BDL
BDL
4
TS
2
Mean
SD
ND
c
ND
ND
1
BDL
1
BDL
1
BDL
1
BDL
1
BDL
1
3.202
1.59
x
10
3
1
BDL
1
BDL
GeoMn
N
1
KTS
2
Mean
SD
GeoMn
N
ND
ND
ND
2
BDL
BDL
BDL
2
BDL
BDL
BDL
2
BDL
BDL
BDL
2
BDL
BDL
BDL
2
BDL
BDL
BDL
2
BDL
BDL
BDL
2
BDL
BDL
BDL
2
BDL
BDL
BDL
2
[2000
0680
and
2001
0304
/
PLG]
~
PROTECTED
~
Acute
Pulmonary
Infectivity
and
Toxicity
/
13
[Pseudozyma
flocculosa
/
STF]
DACO
M4.
2.
3
/
USEPA
OPPTS
885.3150
TS
3
Mean
SD
ND
ND
ND
1
BDL
1
BDL
1
BDL
1
BDL
1
BDL
1
BDL
1
BDL
1
BDL
GeoMn
N
1
KTS
3
Mean
SD
GeoMn
N
ND
ND
ND
2
BDL
BDL
BDL
2
BDL
BDL
BDL
2
BDL
BDL
BDL
2
BDL
BDL
BDL
2
BDL
BDL
BDL
2
BDL
BDL
BDL
2
BDL
BDL
BDL
2
BDL
BDL
BDL
2
TS
7
Mean
SD
GeoMn
N
BDL
BDL
BDL
2
BDL
BDL
BDL
2
BDL
BDL
BDL
2
BDL
BDL
BDL
2
BDL
BDL
BDL
2
BDL
BDL
BDL
2
BDL
BDL
BDL
2
BDL
BDL
BDL
2
BDL
BDL
BDL
2
TS
14
Mean
SD
GeoMn
N
BDL
BDL
BDL
4
BDL
BDL
BDL
4
BDL
BDL
BDL
4
BDL
BDL
BDL
4
BDL
BDL
BDL
4
BDL
BDL
BDL
4
BDL
BDL
BDL
4
BDL
BDL
BDL
4
BDL
BDL
BDL
4
KTS
14
Mean
SD
GeoMn
N
BDL
BDL
BDL
4
BDL
BDL
BDL
4
BDL
BDL
BDL
4
BDL
BDL
BDL
4
BDL
BDL
BDL
4
BDL
BDL
BDL
4
BDL
BDL
BDL
4
BDL
BDL
BDL
4
BDL
BDL
BDL
4
NC
14
Mean
SD
GeoMn
N
BDL
BDL
BDL
4
BDL
BDL
BDL
4
BDL
BDL
BDL
4
BDL
BDL
BDL
4
BDL
BDL
BDL
4
BDL
BDL
BDL
4
BDL
BDL
BDL
4
BDL
BDL
BDL
4
BDL
BDL
BDL
4
a
BDL
below
detection
limit
b
GeoMn
geometric
mean
of
cfu/
tissue
or
cfu/
mL
c
ND
not
done
H.
Reviewer's
Conclusions
Among
the
animals
whose
scheduled
sacrifice
dates
were
on
days
7
or
14,
laboured
respiration
was
observed
in
3/
8
TS
dosed
male
rats,
1/
8
TS
dosed
female
rats,
1/
8
KTS
dosed
male
rats
and
4/
8
KTS
dosed
female
rats.
Laboured
respiration
was
first
noted
in
some
animals
on
day
2
and,
in
some
cases,
would
re
occur
sporadically
up
to
day
11.
The
posture
of
one
female
TS
dosed
animal
was
hunched
on
day
2.
Rough
hair
coat
was
observed
as
early
as
on
day
0
and
up
until
day
11
in
3/
8
TSdosed
male
rats,
1/
4
KTS
dosed
male
rats
and
4/
8
KTS
dosed
female
rats.
One
rat
from
each
of
the
male
TS
dosed,
male
KTS
dosed
and
female
KTS
dosed
groups
had
ocular
discharge.
Nasal
discharge
was
noted
in
2/
8
male
TS
dosed
rats,
1/
8
KTS
dosed
rat
and
2/
8
female
KTS
dosed
rats.
Ocular
and
nasal
discharge
occurred
between
days
2
3.
One
male
TS
dosed
rat
appeared
lethargic
on
day
4.
The
presence
or
absence
of
clinical
symptoms
were
not
indicative
of
spontaneous
deaths.
Due
to
the
large
number
of
spontaneous
deaths
(3/
8
male
TS
dosed
rats,
6/
8
male
KTS
dosed
rats,
2/
8
female
TS
dosed
rats
and
4/
8
female
KTS
dosed
rats)
and
a
number
of
missed
data
collections,
data
for
evaluating
body
weights,
food
consumption
and
relative
organ
weight
were
limited.
At
the
end
of
the
14day
long
study,
administration
of
S.
flocculosa
did
not
have
a
statistically
significant
effect
on
body
weight.
Analysis
of
daily
food
consumption
and
relative
organ
weights
was
skewed
as
it
was
not
determined
or
did
not
include
animals
that
died
prior
to
their
scheduled
sacrifice
dates.
At
necropsy,
lesions
and
enlargement
of
the
lung
were
observed
in
6/
12
male
TS
dosed
rats,
5/
12
male
KTS
dosed
rats,
4/
12
female
TS
dosed
rats
and
6/
12
female
KTS
dosed
rats.
Confluent
dark
areas
were
seen
in
the
kidneys
of
one
male
TS
dosed
rat.
Lesions
and
enlargement
of
the
spleen
were
noted
in
1/
12
[2000
0680
and
2001
0304
/
PLG]
~
PROTECTED
~
Acute
Pulmonary
Infectivity
and
Toxicity
/
14
[Pseudozyma
flocculosa
/
STF]
DACO
M4.
2.
3
/
USEPA
OPPTS
885.3150
male
TS
and
KTS
dosed
rats
and
2/
12
female
KTS
dosed
rats.
Lung
lesions
were
observed
in
one
animal
from
each
of
the
male
TS
dosed,
male
KTS
dosed
and
female
KTS
dosed
groups.
These
necropsy
findings
were
considered
consistent
with
the
method
of
dosing
and
the
body's
normal
immunological
response
to
a
foreign
substance.
Sporothrix
flocculosa
was
detected
in
the
lungs
and
lymph
nodes
and
the
stomach
and
small
intestine
of
TS
dosed
animals
only.
Counts
in
these
tissues
were
below
the
limit
of
detection
by
day
7.
A
number
of
explanations
could
be
provided
for
the
significant
number
of
deaths
of
both
TS
and
KTSdosed
Both
viable
and
heat
killed
test
substance
may
have
been
toxic.
Clinical
observations
(i.
e.,
laboured
breathing)
and
gross
necropsy
findings
(i.
e.,
lung
abnormalities)
may
have
been
the
result
of
pulmonary
blockage
following
intratracheal
administration
of
either
TS
or
KTS.
The
higher
death
rate
of
KTS
dosed
versus
TS
dosed
rats
may
have
been
due
to
toxins
which
were
activated
by
the
autoclaving
step
used
to
produce
the
KTS.
The
relatively
large
size
of
the
test
substance
may
have
contributed
to
the
deaths.
An
alternative
explanation
may
be
a
possible
problem
with
the
dosing
technique,
as
indicated
by
the
presence
of
S.
flocculosa
in
the
stomach
and
small
intestines
on
day
0,
since
none
of
the
undosed
NC
group
animals
died
prior
to
their
scheduled
sacrifice
dates.
The
probability
of
a
dosing
error
was
reinforced
by
a
subsequent
acute
pulmonary
range
finding
study
(see
review
for
separate
Acute
Pulmonary
Range
Finding
Study)
in
which
no
deaths
were
observed
despite
a
higher
dose
of
TS.
Based
on
this
study,
S.
flocculosa
is
toxic,
but
not
infective
or
pathogenic,
at
the
dose
administered
when
introduced
by
the
intratracheal
route
to
male
and
female
CD
rats.
This
study,
however,
is
classified
as
unacceptable
due
to
major
deficiencies
in
the
collected
data.
According
to
USEPA
OPPTS
885.3150,
the
minimum
dose
level
is
10
8
cfu
per
animal.
Animals
in
this
study
were
only
dosed
with
3.
2
x
10
7
cfu.
Furthermore,
the
test
substance
used
in
this
study
was
not
the
technical
grade
active
ingredient
(as
recommended
by
USEPA
OPPTS
885.3150)
but
was
instead
prepared
by
the
test
facility
using
a
method
different
from
the
proposed
manufacturing
method.
The
applicant
has
agreed,
however,
to
upgraded
label
statements
requiring
a
respirator
for
all
workers
and
bystanders
during
times
of
potential
exposure.
I.
Deficiencies
In
addition
to
the
deficiencies
already
noted
above,
the
number
of
air
changes
was
not
reported.
This
additional
deficiency
is
not
considered
to
have
any
impact
on
the
interpretation
of
this
study.
| epa | 2024-06-07T20:31:43.371427 | regulations | {
"license": "Public Domain",
"url": "https://downloads.regulations.gov/EPA-HQ-OPP-2002-0233-0010/content.txt"
} |
EPA-HQ-OPP-2002-0233-0011 | Supporting & Related Material | "2002-09-13T04:00:00" | null | [2000
0680
and
2001
0304
/
PLG]
~
PROTECTED
~
Acute
Pulmonary
Infectivity
and
Toxicity
/
1
[Pseudozyma
flocculosa
/
STF]
DACO
M4.
2.
3
/
USEPA
OPPTS
885.3150
Reviewer:
Esther
Seto
,
Date
January
17,
2002
Peer
Review:
Ibrahim
Barsoum,
PhD
Microbial
Pesticides
Branch
Biopesticides
and
Pollution
Prevention
Division
U.
S.
Environmental
Protection
Agency
_______________
STUDY
TYPE:
Acute
Pulmonary
Range
Finding
Study
PMRA
DATA
CODE
M4.
2.
3
USEPA
OPPTS
885.3150
TEST
MATERIAL
(PURITY):
Sporothrix
flocculosa
[STF],
pure
culture
(MPCA)
in
sterile
water
SYNONYMS:
Pseudozyma
flocculosa,
STF,
Stephanoascus
flocculosa
CITATION:
Harrington,
Kelly,
A.
(July,
1997).
"Acute
Pulmonary
Range
Finding
Toxicity
Test
of
Sporothrix
flocculosa,
a
Fungal
Pesticide,
in
Rats."
IIT
Research
Institute,
Chicago,
Illinois,
USA.
IITRI
Project
No.
L08641,
Study
No.
5
In
Life
Study
Dates:
March
21,
1997
April
4,
1997.
Unpublished.
SPONSOR:
Université
Laval
Québec,
Canada
G1K
7P4
EXECUTIVE
SUMMARY:
A
large
number
of
spontaneous
deaths
were
observed
in
both
treatment
and
control
groups
in
a
prior
acute
pulmonary
toxicity
/
infectivity
assay
(see
separate
review).
In
order
to
determine
whether
the
test
substance
(in
both
its
viable
and
non
viable
forms),
Sporothrix
flocculosa,
was
the
cause
of
the
deaths,
a
subsequent
acute
pulmonary
range
finding
toxicity
study
was
conducted.
In
this
range
finding
study,
groups
of
young
adult
CD
rats
(5/
sex/
dose
level)
were
exposed
by
the
intratracheal
route
to
Sporothrix
flocculosa
(4.2
x
10
8
cfu/
mL)
in
ASTM
Type
1
water
at
doses
of
4.
2
x
10
7
,3.4
x
10
7
,
6.8
x
10
6
and3.4
x
10
6
cfu/
animal.
Animals
were
then
observed
for
14
days.
There
were
no
mortalities
and
all
animals
gained
weight
during
the
study.
LD50
Males
>
4.2
x
10
7
cfu/
animal
Females
>
4.2
x
10
7
cfu/
animal
Combined
>
4.
2
x
10
7
cfu/
animal
No
mortalities
occurred.
Sporothrix
flocuclosa
is
classified
as
being
of
SLIGHT
Toxicity
(EPA
Toxicity
Category
IV)
based
on
adverse
effects
observed
in
some
test
animals.
Rough
hair
coat
occurred
in
a
dose
dependent
manner
with
all
5
animals/
sex
exhibiting
this
symptom
at
the
highest
dose
of
4.
2
x
10
7
CFU/
animal.
One
female
dosed
with4.2
x
10
7
CFU
experienced
tremors,
closed
eyes
and
rough
hair
coat.
[2000
0680
and
2001
0304
/
PLG]
~
PROTECTED
~
Acute
Pulmonary
Infectivity
and
Toxicity
/
2
[Pseudozyma
flocculosa
/
STF]
DACO
M4.
2.
3
/
USEPA
OPPTS
885.3150
This
acute
pulmonary
study
is
considered
supplemental.
This
study
does
not
satisfy
the
guideline
requirement
for
an
acute
pulmonary
study
(OPPTS
885.3150)
in
the
rat
(see
section
II
F).
COMPLIANCE:
Signed
and
dated
GLP
compliance
and
Quality
Assurance
statements
were
provided.
An
unsigned
Data
Confidentiality
statement
was
included.
I.
MATERIALS
AND
METHODS
A.
MATERIALS:
1.
Test
Material:
Sporothrix
flocculosa
(produced
by
test
facility)
Description:
MPCA
Lot/
Batch
#:
UK34
35
Purity:
6.2
x
10
8
cells/
mL
as
determined
by
hemacytometer
count
4.2
x
10
8
cfi/
mL
as
determined
by
plate
count
CAS
#:
n/
a
Verification
of
stability
and
homogeneity
conducted
as
part
of
toxicity
and
pathogenicity
studies.
2.
Sample
Preparation:
Sporothrix
flocculosa
(batch
number
UK34
45)
was
provided
to
the
test
facility
in
the
form
of
two
petri
dishes
(P1
and
P2)
of
yeast
malt
agar
with
white
mould.
IITRI
then
inoculated
two
malt
agar
plates
(P3
and
P4)
with
a
colony
from
P1.
The
test
substance
was
subcultured
approximately
every
three
months
on
malt
agar
to
maintain
viability.
One
week
before
the
start
of
the
in
life
phase,
300
mL
of
yeast
malt
broth
was
inoculated
with
a
subculture
of
the
test
substance
and
incubated
at
room
temperature
for
seven
days.
On
the
day
of
dosing,
the
broth
culture
was
centrifuged
and
resuspended
in
4
mL
of
ASTM
type
1
water.
The
titre
of
the
resuspended
solution
was
determined
to
be
6.2
x
10
8
cells/
mL
by
hemacytometer
count
(corresponding
to
4.
2
x
10
8
colony
forming
units
(cfu)/
mL
as
determined
by
plate
count).
The
solution
was
diluted
to
5
x
10
8
,1
x
10
8
and5
x
10
7
cells/
mL
(corresponding
to
3.
4
x
10
8
,6.8
x
10
7
and
3.
4
x
10
7
cfu/
mL,
respectively).
3.
Test
animals:
Species
/
Strain:
CD
Rat
Age/
weight
at
dosing:
approximately
6
weeks
of
age
males:
195.11
224.48
g
females:
155.88
188.64
g
Source:
Charles
River
Laboratories
Portage,
MI
Housing:
During
quarantine,
the
rats
were
housed
up
to
two
per
cage
in
polypropylene
cages
with
hardwood
chip
bedding.
Upon
assignment
to
test
groups
,
and
for
the
remainder
of
the
study,
the
rats
were
singly
housed.
Diet:
Certified
Purina
Rodent
Chow
5002
(PMI
Feeds
Inc.,
St.
Louis,
MO)
ad
libitum
Water:
City
of
Chicago
water
ad
libitum
Environmental
conditions:
Temperature:
Humidity:
Air
changes:
Photoperiod:
20
24
C
8
35
%
Not
reported
12
hrs
dark
/
12
hrs
light
Acclimation
period:
one
week
[2000
0680
and
2001
0304
/
PLG]
~
PROTECTED
~
Acute
Pulmonary
Infectivity
and
Toxicity
/
3
[Pseudozyma
flocculosa
/
STF]
DACO
M4.
2.
3
/
USEPA
OPPTS
885.3150
B.
STUDY
DESIGN
and
METHODS:
1.
In
life
dates
Start:
March
21,
1997
End:
April
4,
1997
3.
Animal
assignment
and
treatment
Animals
were
assigned
to
the
test
groups
noted
in
Table
1.
Rats
were
anesthetized
with
ether
and
administered
a
dose
of
0.
1
ml
test
substance
intratracheally.
They
were
observed
twice
daily
(only
once
daily
on
weekends)
and
weighed
weekly
for
14
days
after
dosing.
Survivors
were
sacrificed
and
necropsies
were
not
performed.
TABLE
1.
Concentrations,
exposure
conditions,
mortality/
animals
treated
Group
Dose
(cfu)
Mortality
(#
dead/
total)
Males
Females
Combined
1
4.2
x
10
7
0/
5
0/
5
0/
10
2
3.4
x
10
7
0/
5
0/
5
0/
10
3
6.8
x
10
6
0/
5
0/
5
0/
10
4
3.4
x
10
6
0/
5
0/
5
0/
10
5.
Statistics
TheLD50
was
set
at
greater
than
4.
2
x
10
7
cfu/
animal.
No
calculations
were
necessary.
II.
RESULTS
AND
DISCUSSION:
A.
Mortality
is
given
in
Table
1.
The
LD50
(C.
I.)
for
males
is
>
4.
2
x
10
7
cfu/
animal.
for
females
is
>
4.
2
x
10
7
cfu/
animal
combined
is
>
4.
2
x
10
7
cfu/
animal.
B.
Clinical
observations
A
summary
of
the
incidence
of
clinical
observations
is
presented
in
Table
2.
TABLE
2.
Clinical
Observations
Observations
Dose
(CFU/
animal)
4.2
x
10
7
3.4
x
10
7
6.8
x
10
6
3.4
x
10
6
males
females
males
females
males
females
males
females
rough
hair
coat
555211
0
0
tremors
010000
0
0
closed
eye(
s)
010000
0
0
no
signs
observed
000344
5
5
[2000
0680
and
2001
0304
/
PLG]
~
PROTECTED
~
Acute
Pulmonary
Infectivity
and
Toxicity
/
4
[Pseudozyma
flocculosa
/
STF]
DACO
M4.
2.
3
/
USEPA
OPPTS
885.3150
Rough
hair
coat
occurred
in
a
dose
dependent
manner
beginning,
in
some
animals,
on
day
3
with
sporadic
re
occurrence
until
day
11.
One
female,
dosed
at
4.
2
x
10
7
CFU,
presented
with
tremors,
closed
eyesand
rough
hair
coat.
The
tremors
were
noted
only
on
day
3
and
the
closed
eyes
were
noted
on
days
3
and
5.
C.
Body
Weight
All
animals
gained
weight
during
the
study.
One
female,
dosed
at
4.
2
x
10
7
CFU,
lost
weight
between
days
0
and
7
but
gained
weight
thereafter.
Statistical
analysis
was
not
conducted
to
compare
body
weight
data
between
groups.
E.
Reviewer's
Conclusions
The
recommended
test
substance
for
an
acute
pulmonary
study
is
the
technical
grade
active
ingredient
(TGAI).
Instead,
the
test
substance
used
in
this
study
was
the
MPCA
and
was
prepared
by
the
test
facility
using
a
method
different
from
the
proposed
manufacturing
methods.
The
applicant
has
agreed
to
upgraded
label
statements
requiring
respirators
for
all
users.
According
to
USEPA
OPPTS
885.3150,
Acute
Pulmonary
Toxicity/
Pathogenicity,
the
minimum
dose
is
10
8
units
of
the
MPCA
per
test
animal.
The
maximum
dose
level
used
in
this
study,
however,
was
only
4.
2
x
10
7
CFU/
animal.
Furthermore
the
purpose
of
this
study
was
to
determine
the
toxicity
range
of
S.
flocculosa
in
order
to
aid
in
the
interpretation
of
the
large
number
of
spontaneous
deaths
from
the
acute
pulmonary
toxicity
/
infectivity
study
conducted
previously.
Infectivity,
as
required
by
USEPA
OPPTS
885.3150,
was
not
addressed
by
this
study.
This
study
does
not
comply
with
guideline
requirements
and
is,
therefore,
considered
supplemental.
The
range
finding
study
suggests
that
the
LD50
of
S.
flocculosa
is
greater
than
4.
2
x
10
7
CFU/
animal
in
male
and
female
rats.
Sporothrix
flocculosa
is
classified
as
slightly
toxic
based
on
rough
hair
coat
(observed
in
55%
of
treated
male
rats
and
40%
of
treated
female
rats)
which
occurred
in
a
dose
dependent
manner.
F.
Deficiencies
In
addition
to
the
deficiencies
already
noted
above,
the
number
of
air
changes
was
not
reported
and
the
relative
humidity
of
the
room
in
which
the
animals
were
housed
fell
below
the
target
of
3070
These
additional
deficiencies
are
not
considered
to
have
any
impact
on
the
interpretation
of
this
study.
| epa | 2024-06-07T20:31:43.377191 | regulations | {
"license": "Public Domain",
"url": "https://downloads.regulations.gov/EPA-HQ-OPP-2002-0233-0011/content.txt"
} |
EPA-HQ-OPP-2002-0233-0012 | Supporting & Related Material | "2002-09-13T04:00:00" | null | [
Sporodex
L
/
2001
0304
/
PLG
]
~
PROTECTED
~
Acute
Eye
Irritation
Study
/
1
[
Pseudozyma
flocculosa
/
2000
0680
/
STF]
DACO
M4.
9
/
USEPA
OPPTS
870.2500
Reviewer:
Esther
Seto
,
Date
Feb.
1,
2001
Peer
Review:
Ibrahim
Barsoum,
PhD
Microbial
Pesticides
Branch
Biopesticides
and
Pollution
Prevention
Division
U.
S.
Environmental
Protection
Agency
_______________
STUDY
TYPE:
Primary
Eye
Irritation
Rabbit
PMRA
DATA
CODE
M4.9
/
USEPA
OPPTS
870.2500
TEST
MATERIAL
(PURITY):
Sporodex
WP
2000
formulation
5.7
x
10
8
CFU/
g
SYNONYMS:
Pseudozyma
flocculosa,
Sporothrix
flocculosa
CITATION:
Findlay,
John.
(December,
1999).
"Primary
Eye
Irritation
Study
of
Sporodex."
IIT
Research
Institute,
Life
Sciences
Operation,
Chicago,
Illinois.
Laboratory
Project
ID
1178
SN1.
InLife
Study
Dates:
November
1,
1999
November
8,
1999.
Unpublished.
SPONSOR:
Université
Laval
Départment
de
phytologie
Cité
universitaire
Québec,
Canada
EXECUTIVE
SUMMARY:
Administration
of
0.
1
g
of
Sporodex
WP
to
the
eyes
of
rabbits
resulted
in
slight
conjunctival
redness
in
5/
6
animals
at
the
1
hour
scoring
interval
and
in
2/
6
rabbits
at
the
24
hour
scoring
interval.
By
the
48
hour
scoring
interval,
all
signs
of
ocular
irritation
had
subsided.
There
were
no
other
adverse
clinical
symptoms
or
mortalities
during
the
7
day
observation
period.
The
maximum
irritation
score
(MIS)
was
1.
7
at
the
1
hour
scoring
interval
and
the
maximum
average
score
(MAS),
over
the
24,
48
and
72
hour
scoring
intervals,
was
0.
22.
Based
on
the
MAS,
Sporodex
WP
was
classified
as
minimally
irritating.
The
test
substance
used
in
this
study
was
a
wettable
powder
formulation
containing
a
potential
ocular
irritant
(see
appendix
I).
The
current
formulation,
Sporodex
L,
contains
a
much
lower
level
of
the
potential
irritant
(see
appendix
II).
Therefore,
Sporodex
L
is
expected
to
be
less
irritating
to
the
eye
than
Sporodex
WP.
This
study
fulfills
the
requirements
of
an
acute
eye
irritation
study
(OPPTS
870.2400)
and
is
considered
acceptable.
COMPLIANCE:
Signed
and
dated
GLP
and
Data
Confidentiality
statements
were
provided.
A
Quality
Assurance
statement
was
not
included.
A.
MATERIALS:
[
Sporodex
L
/
2001
0304
/
PLG
]
~
PROTECTED
~
Acute
Eye
Irritation
Study
/
2
[
Pseudozyma
flocculosa
/
2000
0680
/
STF]
DACO
M4.
9
/
USEPA
OPPTS
870.2500
1.
Test
Material:
Sporodex
WP
2000
formulation
Description:
tan
powder
Lot/
Batch
#:
Lot
No.
CWB1/
23
08
99
Purity:
5.7
x
10
8
CFU/
g
CAS
#
TGAI:
n/
a
The
titre
of
the
test
substance
was
determined
by
the
Sponsor
by
using
a
basic
plating
technique.
2.
Vehicle
and/
or
positive
control:
The
test
substance
was
applied
undiluted.
3.
Test
animals:
Species:
Rabbit
Strain:
New
Zealand
White
Age/
weight
at
dosing:
approximately
11.5
weeks
of
age
at
time
of
dosing
1.90
2.
30
kg
at
time
of
receipt
body
weight
not
measured
on
day
of
dosing
Source:
Kuiper
Rabbit
Ranch,
Gary,
IN.
Housing:
Animals
were
individually
housed
in
suspended
stainless
steel
cages.
Absorbent
cage
liners
were
placed
in
pans
below
the
floor
of
each
cage
to
absorb
liquids.
Diet:
Each
rabbit
was
provided
with
approximately
150g
of
Certified
Purina
Lab
Rabbit
Chow
HF
#5325
(PMI
Feeds,
St.
Louis,
MO)
daily.
Water:
City
of
Chicago
tap
water
was
provided
ad
libitum.
Environmental
conditions:
temperature:
21.0
22.0
C
relative
humidity:
34
69%
light
/
dark
cycle:
12
hours
light
/
12
hours
dark
Acclimation
period:
Animals
were
acclimatized
for
11
days.
Each
animal
was
identified
with
an
ear
tag
and
a
cage
card.
B.
STUDY
DESIGN
and
METHODS:
1.
In
life
dates
start
date:
November
1,
1999
termination
date:
November
8,
1999
2.
Animal
Assignment
and
Treatment
A
single
group
of
6
female
young
adult
rabbits
were
selected
for
treatment.
Prior
to
treatment,
animals
were
evaluated
for
general
health
and
their
eyes
were
examined
for
corneal
lesions
with
and
without
the
aid
of
2%
fluorescein
and
ultraviolet
light.
On
the
day
of
dosing,
0.
1g
of
Sporodex
WP,
containing
5.
7
x
10
7
CFUof
Pseudozyma
flocculosa,
was
placed
in
the
everted
lower
lid
of
the
right
eye
of
each
animal
and
the
eyelids
were
held
closed
for
approximately
two
seconds.
The
left
eye
of
each
animal
served
as
an
untreated
control.
The
treated
eye
was
rinsed
with
lukewarm
water
24
hours
after
instillation
of
the
test
substance.
3.
Clinical
Observations
All
rabbits
were
observed
daily
for
mortality
and
moribundity
for
7
days
following
administration
of
the
test
substance..
4.
Ocular
Examinations
At
1,
24,
48,
72
hours,
and
4
and
7
days
after
administration
of
the
test
substance,
treated
and
control
eyes
were
graded
for
ocular
lesions
according
to
the
criteria
of
Draize.
The
cornea
was
examined
for
degree
and
area
of
opacity;
the
iris
for
deepened
folds,
congestion,
swelling,
circumcorneal
hyperemia
and
reaction
to
light;
and
the
conjunctiva
for
redness,
chemosis
and
discharge.
A
slit
penlight
was
used
in
the
scoring
examination.
In
order
to
detect
corneal
lesions,
eyes
were
examined
using
fluorescein
at
the
24
hour
scoring
interval.
[
Sporodex
L
/
2001
0304
/
PLG
]
~
PROTECTED
~
Acute
Eye
Irritation
Study
/
3
[
Pseudozyma
flocculosa
/
2000
0680
/
STF]
DACO
M4.
9
/
USEPA
OPPTS
870.2500
5.
Necropsy
After
the
final
observation,
the
rabbits
were
euthanized
by
anaesthetic
overdose
using
sodium
pentobarbital
and
discarded
without
necropsy.
II.
RESULTS
AND
DISCUSSION:
A.
Clinical
Observations
No
deaths
occurred
during
the
study.
B.
Ocular
Examinations
Individual
eye
irritation
scores
are
presented
in
Table
1.
One
hour
after
test
material
administration,
slight
conjunctival
redness
(grade
1
vessels
definitely
injected
above
normal)
was
observed
in
5/
6
animals.
By
the
24
hour
scoring
interval,
only
2/
6
animals
continued
to
exhibit
slight
conjunctival
redness.
All
signs
of
ocular
irritation
were
absent
at
the
48
hour
scoring
interval.
Aside
frommild
redness,
no
other
signs
of
ocular
irritation
were
observed
at
any
point
of
the
study.
Based
on
the
Draize
method
of
determining
ocular
irritation,
the
maximumirritation
score,
occurring
at
the
1
hour
scoring
interval,
was
1.
7
(out
of
a
possible
score
of
110)
and
the
maximum
average
score,
calculated
over
the
24,
48
and
72
hour
scoring
intervals,
was
0.
22.
C.
Reviewer's
Conclusions
Administration
of
Sporodex
WP
to
the
eyes
of
rabbits
resulted
in
slight
conjunctival
redness
in
5/
6
animals
at
the
1
hour
scoring
interval
and
in
2/
6
rabbits
at
the
24
hour
scoring
interval.
No
other
signs
of
ocular
irritation
were
observed
at
any
point
of
the
study.
There
were
no
other
adverse
clinical
symptoms
or
mortalities
during
the
7
day
observation
period.
The
maximum
irritation
score
was
1.
7
at
the
1
hour
scoring
interval
and
the
maximum
average
score
was
0.
22.
The
test
substance
used
in
this
study
was
a
wettable
powder
formulation
(see
appendix
I)
and
its
constituent
formulation
ingredients
are
expected
to
be
more
irritating
to
the
eye
than
the
formulation,
Sporodex
L
(see
appendix
II),
that
is
currently
being
submitted
for
registration.
Sporodex
WP
and,
therefore,
Sporodex
L
are
considered
mildly
irritating
to
the
eye
and
no
signal
words
are
required
on
the
label.
Standard
label
statements
instructing
users
to
avoid
contact
with
eyes
are
sufficient.
This
study
fulfills
the
requirements
of
an
acute
eye
irritation
study
(OPPTS
870.2400)
and
is
considered
acceptable.
D.
Deficiencies
Data
pertaining
to
the
untreated
control
eyes
were
not
submitted.
This
information,
however,
is
not
critical
since
severe
effects
were
not
noted
in
the
treated
eyes.
No
other
major
or
minor
deficiencies
were
identified.
[
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L
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2001
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Table
1
Individual
Eye
Irritation
Scores
Cornea:
Density
of
Opacity
(A
=
Degree
of
Denisty,
B
=
Area
of
Cornea
Involved)
Scoring
Interval
1
hour
24
hours
48
hours
72
hours
4
days
7
days
Animal
No.
SexAB
AB
AB
AB
AB
A
B
351F0
0
00
0
0
00
0
0
00
352F0
0
00
0
0
00
0
0
00
353F0
0
00
0
0
00
0
0
00
354F0
0
00
0
0
00
0
0
00
355F0
0
00
0
0
00
0
0
00
356F0
0
00
0
0
00
0
0
00
Iris
Scoring
Interval
Animal
No.
Sex
1
hour
24
hours
48
hours
72
hours
4
days
7
days
351F0
0
00
00
352F0
0
00
00
353F0
0
00
00
354F0
0
00
00
355F0
0
00
00
356F0
0
00
00
Conjunctiva
(A
=
Erythema,
B
=
Chemosis,
C
=
Discharge)
Scoring
Interval
1
hour
24
hours
48
hours
72
hours
4
days
7
days
Animal
No.
SexABCABCAB
CA
BC
A
BCABC
[
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870.2500
351F1
0
0
00
0
0
00
0
0
00
0
0
00
0
352F0
0
0
00
0
0
00
0
0
00
0
0
00
0
353F1
0
0
00
0
0
00
0
0
00
0
0
00
0
354F1
0
0
10
0
0
00
0
0
00
0
0
00
0
355F1
0
0
10
0
0
00
0
0
00
0
0
00
0
356F1
0
0
00
0
0
00
0
0
00
0
0
00
0
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L
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870.2500
Appendix
I:
Formulation
Ingredients
for
Sporodex
WP
Ingredient
Purpose
%
Weight
Pseudozyma
flocculosa
active
ingredient
2
(1.
5
2.
5)
Arabic
Gum
coating
82
(80
84)
Lactose
stabilizer
5.5
(3.
7
8)
Silicon
Dioxide
dispersing
agent
1.5
(0.
74
3)
Water
diluent
9
(5
10)
Total
100
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870.2500
Appendix
II:
Formulation
Ingredients
for
Sporodex
L
Ingredient
Purpose
%
Weight
Pseudozyma
flocculosa
active
ingredient
1.
3
(0.
5
3.
0)
Arabic
Gum
coating
14.
5
(12
17)
Lactose
stabilizer
1.
5
(1
2)
Silicon
Dioxide
dispersing
agent
0.
5
(0.
2
0.
8)
Water
diluent
82.2
(75
88)
Total
100
| epa | 2024-06-07T20:31:43.380309 | regulations | {
"license": "Public Domain",
"url": "https://downloads.regulations.gov/EPA-HQ-OPP-2002-0233-0012/content.txt"
} |
EPA-HQ-OPP-2002-0233-0013 | Supporting & Related Material | "2002-09-13T04:00:00" | null | [Sporodex
L
/
2001
0304
/
PLG]
~
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Acute
Oral
Infectivity
and
Toxicity
Study
/1
[Pseudozyma
flocculosa
/
2000
0680
/
STF]
DACO
M4.
2.
2
/
USEPA
OPPTS
885.3050
Reviewer:
Esther
Seto
,
Date
January
8,
2002
Peer
Review:
Ibrahim
Barsoum,
PhD
Microbial
Pesticides
Branch
Biopesticides
and
Pollution
Prevention
Division
U.
S.
Environmental
Protection
Agency
_______________
STUDY
TYPE:
Acute
Oral
Toxicity
Rat
PMRA
DATA
CODE
M4.2.
2
/
USEPA
OPPTS
885.3050
TEST
MATERIAL
(PURITY):
Sporodex®
(WP
formulation)
1997
Formulation
5.6
5.8
x
10
8
Pseudozyma
flocculosa
colony
forming
units
/
mL
SYNONYMS:
Pseudozyma
flocculosa
[STF],
Sporothrix
flocculosa,
Stephanoascus
flocculosa
CITATION:
Descôteaux,
Jean
Paul.
(September
9,
1996).
"Report
of
an
Acute
Oral
Toxicity
/
Infectivity
Study
of
Sporodex®
Administered
by
Gavage
to
Fisher
344
Rats."
Institut
Armand
Frappier,
Laval,
Québec,
Canada.
Study
Number
951890.
In
Life
Study
Dates:
February
6
7,
1996
February
27
28,
1996.
Unpublished.
SPONSOR:
Plant
Products
Co.,
Ltd.
314
Orenda
Road
Brampton,
Ontario
Canada
EXECUTIVE
SUMMARY:
In
an
acute
oral
toxicity
study,
groups
of
fasted,
6
7
week
old
Fisher
344
rats
(12/
sex)
were
given
a
single
oral
dose
of
Sporodex
WP
in
USP
sterile
water
for
injection
at
doses
of
5.8
x
10
8
colony
forming
units
(CFU)
per
animal
for
males
and
5.
6
x
10
8
CFU
per
animal
for
females.
The
animals
were
then
observed
for
a
period
of
up
to
21
days
with
interim
scheduled
sacrifices.
Oral
LD50
Males
>
5.8
x
10
8
CFU
per
animal.
Females
>
5.6
x
10
8
CFU
per
animal.
No
mortalities
occurred.
Limit
test.
Pseudozyma
flocculosa
is
of
LOW
Toxicity
based
on
theLD50
in
female
Fisher
344
rats.
There
were
no
clinical
signs
of
toxicity
and
all
of
the
animals
gained
weight
during
the
study.
No
gross
findings
were
observed
at
necropsy.
No
label
comments
are
required.
This
acute
oral
study
is
classified
acceptable.
This
study
satisfies
the
guideline
requirement
for
an
acute
oral
study
(OPPTS
885.3050)
in
the
rat.
COMPLIANCE:
Signed
and
dated
GLP,
Quality
Assurance,
and
Data
Confidentiality
statements
were
[Sporodex
L
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provided.
The
study
meets
GLP
standards
with
the
following
exceptions:
1)
The
purity
and
the
characterization
of
the
active
ingredient
and
the
stability
of
the
test
material
was
established
by
the
sponsor's
representative's
laboratory
and
was
not
included
in
the
compliance
statement.
2)
Some
SOPs
were
used
as
drafts.
I.
MATERIALS
AND
METHODS
A.
MATERIALS:
1.
Test
Material:
Sporodex®
Description:
pinkish
fine
powder
Lot/
Batch
#:
UK34
35
Purity:
3.5
x
10
8
colony
forming
units
/
g
CAS
#:
n/
a
The
purity
and
the
stability
of
the
test
substance
was
established
and
documented
by
the
sponsor's
representative
(Dr.
Richard
Bélanger;
Université
Laval).
2.
Sample
Preparation:
A
solution
of
the
test
substance
was
prepared
by
dissolving
0.
5
g
of
Sporodex®
in
100
mL
of
USP
grade
sterile
water
for
injection
(Abbott
Laboratories,
Montréal,
Québec)
and
mixing
in
a
blender
for
approximately
2
minutes.
The
solution
was
adjusted
by
weight
per
volume
to
establish
the
recommended
dose
of
1
x
10
8
CFU/
mL
by
the
addition
of
sterile
water
and
mixing
with
a
stir
bar.
Half
of
the
solution
was
heat
treated
for
approximately
20
minutes
at
82
±
2
C
to
render
the
active
ingredient
non
viable
and
was
used
as
killed
test
substance
[TS(
K)]
to
dose
control
group
animals.
The
rest
of
the
solution
was
used
as
viable
test
substance
[TS(
V)]
to
dose
animals
in
the
treatment
groups.
Immediately
before
and
after
dosing,
various
dilutions
of
TS(
K)
and
TS(
V)
were
plated
on
yeast
malt
peptone
dextrose
agar
(YMA)
media
(Quélab,
Montréal,
Québec),
containing
0.
05
g/
L
of
chloramphenicol,
to
confirm
their
titres.
The
titre
of
the
TS(
V)
preparation
was
5.
6
5.
8
x
10
8
CFU/
g
and
the
titre
of
the
TS(
K)
preparation
was
0
CFU/
g.
USP
grade
sterile
water
for
injection
(Abbott
Laboratories,
Montréal,
Québec)
was
also
used
as
a
control.
3.
Test
animals:
Species:
Rat
Strain:
Fisher
344,
substrain
NHsd
Age/
weight:
animal
receipt
4
5
weeksold
males:
67.3
80.5
g
(based
on
ten
animals)
females:
68.3
82.1
g
(based
on
ten
animals)
at
time
of
dosing
6
7
weeksold
males:
111
129
g
females:
100
109
g
Source:
Harlan
Sprague
Dawley
Inc.
Indianapolis,
Indiana,
USA
[Sporodex
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885.3050
Housing:
Rats
were
individually
housed,
in
wire
bar
covered
cages
with
beta
chip
bedding,
throughout
the
acclimation
and
treatment
periods.
Diet:
Prolab
Rodent
Chow
4018
(Charles
River
Laboratories,
St
Constant,
Québec)
was
provided
ad
libitum
for
the
first
week
of
the
acclimation
period.
For
the
remainder
of
the
study,
the
rats
received
a
diet
of
certified
Rodent
Diet
5002
(PMI
Feeds
Inc.)
ad
libitum.
Water:
Municipal
tap
water
was
provided
ad
libitum
Environmental
conditions:
Temperature:
Humidity:
Air
changes:
Photoperiod:
21
24
C
19
54
%
not
reported
12
hrs
dark
/
12
hrs
light
Acclimation
period:
approximately
two
weeks
B.
STUDY
DESIGN
and
METHODS:
1.
In
life
dates
Start:
February
6
7,
1996
End:
February
27
28,
1996
2.
Animal
assignment
and
treatment
Animals
were
assigned,
on
the
basis
of
body
weight,
to
the
test
groups
noted
in
Table
1.
Individual
body
weights
did
not
vary
from
the
group
mean
body
weight
(by
sex)
by
more
than
20%.
Following
a
16
hour
fast,
rats
were
given
a
single
dose
of
TS(
V),
TS(
K)
or
USP
grade
sterile
water
by
gavage
then
observed
daily
and
weighed
weekly
until
sacrifice.
Necropsies
were
performed
following
sacrifice
on
the
scheduled
days.
TABLE
1.
Doses,
mortality/
animals
treated
Test
Group
Test
Substance
Dose
Level
Sacrifice
Day
Males
Females
Combined
1
TS(
V)
:5.8
x
10
8
CFUin
1
mL
:5.6
x
10
8
CFUin
1
mL
0
0/
4
0/
4
0/
8
2
TS(
K)
:
heat
killed
active
ingredient
equal
to
5.
8
x
10
8
CFUin
1
mL
:
heat
killed
active
ingredient
equal
to
5.
6
x
10
8
CFUin
1
mL
0
0/
4
0/
4
0/
8
3
TS(
V)
:5.8
x
10
8
CFUin
1
mL
:5.6
x
10
8
CFUin
1
mL
7
0/
4
0/
4
0/
8
4
TS(
K)
:
heat
killed
active
ingredient
equal
to
5.
8
x
10
8
CFUin
1
mL
:
heat
killed
active
ingredient
equal
to
5.
6
x
10
8
CFUin
1
mL
7
0/
4
0/
4
0/
8
5
TS(
V)
:5.8
x
10
8
CFUin
1
mL
:5.6
x
10
8
CFUin
1
mL
21
0/
4
0/
4
0/
8
6
TS(
K)
:
heat
killed
active
ingredient
equal
to
5.
8
x
10
8
CFUin
1
mL
:
heat
killed
active
ingredient
equal
to
5.
6
x
10
8
CFUin
1
mL
21
0/
4
0/
4
0/
8
[Sporodex
L
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2001
0304
/
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7
Control
1
mL
of
USP
sterile
water
for
injection
21
0/
4
0/
4
0/
8
3.
Clinical
Observations
Cage
side
observations
for
mortality
and
moribundity
were
made
at
least
once
daily.
Cage
side
observations
also
included
examination
of
the
general
condition,
appearance
and
demeanor
of
each
rat,
and
observation
of
the
animal's
movement
within
the
cage.
4.
Body
Weights
Body
weights
were
measured
upon
receipt
of
the
animals,
on
the
day
of
randomization,
prior
to
gavage
and
weekly
thereafter.
All
body
weight
measurements
were
taken
following
an
overnight
fasting
period.
5.
Feed
Consumption
Measurement
of
feed
consumption
began
on
the
day
of
dosing
and
continued
weekly
thereafter.
6.
Necropsy
Animals
were
sacrificed
according
to
the
schedule
in
Table
1.
All
test
animals
were
fasted
overnight
prior
to
sacrifice.
On
the
day
of
scheduled
sacrifice,
animals
were
weighed
and
anaesthetized
using
Ketamine/
Xylazine
prior
to
blood
collection
by
cardiac
puncture.
The
necropsy
included
an
examination
of
the
external
surface
of
the
body,
all
orifices,
cranial
cavity,
external
surface
of
the
brain,
the
thoracic,
abdominal
and
pelvic
cavities
and
the
viscera.
The
following
tissues
were
collected
from
each
test
animal
for
enumeration
of
the
test
substance:
brain,
lungs,
liver,
kidneys,
stomach
and
small
intestine
(duodenum,
jejunum,
ileum),
caecum,
mesenteric
lymph
nodes,
and
spleen.
7.
Sensitivity
of
Detection
Aliquots
containing
the
viable
test
substance
diluted
to
approximately
10
4
,
10
5
,and10
6
viable
units/
mL
were
placed
into
sterile
bags
(Seward
Medical,
England)
and
homogenized
with
either
the
lungs
or
caecums
removed
from
3
male
and
3
female
rats.
Additional
samples
containing
the
test
substance
without
the
addition
of
animal
tissues
served
as
the
untreated
controls.
The
homogenized
samples
and
the
untreated
controls
were
standardized
for
volume
and
plated
on
duplicate
plates
of
YMA
media
supplemented
with
0.
05
g/
L
of
chloramphenicol.
After
incubation
at
approximately
27
C
for
36
±
12
hours,
the
substance
titres
were
determined
by
counting
colonies.
The
sensitivity
of
detection
was
expressed
as
a
factor
of
the
percent
recovery
and
the
limit
of
detection
observed.
8.
Enumeration
of
Test
Substance
Each
organ,
aseptically
collected
at
the
time
of
necropsy,
was
weighed
and
homogenized.
Organ
homogenates
and
blood
samples
were
diluted,
as
necessary,
with
peptone
water.
A
100
µl
aliquot
was
then
plated
on
duplicate
YMA
agar
supplemented
with
0.
05
g/
L
of
chloramphenicol
and
incubated
at
approximately
27
C
for
36
±
12
hours.
Only
plates
with
counts
of
between
10
120
colonies
were
included
for
the
determination
of
the
number
of
CFU/
g
of
tissue
or
CFU/
mL
of
blood.
The
number
of
CFU/
g
of
organ
was
calculated
as
follows:
(mean
plate
count
/
0.
1
g
of
organ
homogenate)*
weight
of
organ
homogenate
weight
of
organ.
9.
Statistics
The
analysis
of
variance
(ANOVA)
method
was
used
to
determine
whether
statistically
significant
differences
in
body
weight
and
feed
consumption
existed
between
groups.
II.
RESULTS
AND
DISCUSSION:
A.
Mortality
is
given
in
Table
1.
[Sporodex
L
/
2001
0304
/
PLG]
~
PROTECTED
~
Acute
Oral
Infectivity
and
Toxicity
Study
/5
[Pseudozyma
flocculosa
/
2000
0680
/
STF]
DACO
M4.
2.
2
/
USEPA
OPPTS
885.3050
The
oral
LD50
for
males
is
greater
than
5.
8
x
10
8
CFU
per
animal.
females
is
greaterthan5.6
x
10
8
CFU
per
animal.
B.
Clinical
observations
There
were
no
clinical
signs
of
toxicity
at
any
point
of
the
study.
All
animals
appeared
normal
in
general
condition,
demeanor
and
movement.
C.
Body
Weight
All
animals
gained
weight
(see
Table
2
for
summary).
No
statistically
significant
difference
in
body
weight
or
weight
gain
between
TS(
K),
TS(
V)
and
USP
sterile
water
control
groups
was
found.
A
significant
statistical
difference
(P
<0.001),
however,
was
found
between
sexes
for
all
groups
including
control
groups
and
was,
therefore,
not
considered
treatment
related.
TABLE
2.
Rat
body
weight
summary
Test
Substance
Sex
Body
Weight
(g)
Day
0
a
Day
7
b
Day
14
c
Day
21
c
TS(
V)
M
120
±
9
150
±
14
173
±
8
197
±
7
TS(
K)
M
121
±
8
148
±
12
165
±
23
190
±
26
USP
sterile
water
M
122
±
7
149
±
9
175
±
11
200
±
11
TS(
V)
F
104
±
4
121
±
6
132
±
4
143
±
4
TS(
K)
F
105
±
4
123
±
4
129
±
5
141
±
5
USP
sterile
water
F
105
±
4
122
±
7
131
±
9
143
±
10
a
:
each
value
represents
the
mean
and
standard
deviation
calculated
on
the
basis
of
12
animals
for
TS(
V)
and
TS(
K)
treatment
groups
and
on
the
basis
of
4
animals
for
the
USP
sterile
water
group
b
:
each
value
represents
the
mean
and
standard
deviation
calculated
on
the
basis
of
8
animlas
for
TS(
V)
and
TS(
K)
treatment
groups
and
on
the
basis
of
4
animals
for
the
UPS
sterile
water
group
c
:
each
value
represents
the
mean
and
standard
deviation
calculated
on
the
basis
of
4
animals
for
TS(
V)
and
TS(
K)
treatment
groups
and
on
the
basis
of
4
animals
for
the
UPS
sterile
water
group
D.
Feed
Consumption
No
statistically
significant
difference
in
weekly
feed
consumption
between
TS(
K),
TS(
V)
and
USP
sterile
water
control
groups
was
found.
A
significant
statistical
difference
(P
<0.001),
however,
was
found
between
sexes
for
all
groups
including
control
groups
and
was,
therefore,
not
considered
treatment
related.
E.
Necropsy
There
were
no
gross
necropsy
findings
for
any
of
the
animals
in
the
study.
F.
Sensitivity
of
Detection
In
the
presence
of
lung
and
caecum
tissue,
the
percentage
recovery
of
the
active
ingredient
was
61
91%
and
54
83%,
respectively.
The
sensitivity
of
detection
in
the
lungs
was
established
as
132
CFU/
mL.
The
sensitivity
of
detection
in
the
caecum
was
established
as
142
CFU/
mL.
Assuming
that
the
density
of
the
organ
homogenate
was
1
g/
mL,
the
sensitivities
of
detection
in
the
lungs
and
in
the
caecum
could
also
be
expressed
as
132
CFU/
g
and
142
CFU/
g,
respectively.
G.
Enumeration
of
the
Test
Substance
Pseudozyma
flocculosa,
at
levels
of
1000
and
160
(estimated
[Sporodex
L
/
2001
0304
/
PLG]
~
PROTECTED
~
Acute
Oral
Infectivity
and
Toxicity
Study
/6
[Pseudozyma
flocculosa
/
2000
0680
/
STF]
DACO
M4.
2.
2
/
USEPA
OPPTS
885.3050
value)
CFU/
g
of
tissue,
was
recovered
from
the
stomach
and
small
intestines
of
2/
4
male
rats
which
were
sacrificed
one
hour
after
administration
of
TS(
V).
Pseudozyma
flocculosa
was
also
recovered
from
the
stomach
and
small
intestines
of
1/
4
female
rats
sacrificed
one
hour
after
administration
of
TS(
V)
at
a
level
of
780
CFU/
g
of
tissue.
No
Pseudozyma
flocculosa
was
recovered
by
the
seventh
day
post
dosing
in
any
of
the
animals
or
in
any
of
the
other
collected
organs
or
fluids.
H.
Reviewer's
Conclusions:
According
to
U.
S.
EPA
OPPTS
885.3050,
the
recommended
test
substance
for
an
acute
oral
toxicity/
pathogenicity
study
is
the
TGAI.
The
test
substance
used
in
this
study
was
a
1997
formulation
of
Sporodex
WP
(wettable
powder).
PMRA
and
EPA
previously
accepted
the
wettable
powder
end
use
product
as
the
test
substance.
A
change
in
the
intended
formulation
of
the
end
use
product
from
a
wettable
powder
to
a
liquid
formulation
(Sporodex
L),
however,
triggered
the
need
for
a
rationale
for
the
test
substance.
The
applicant
requested
a
waiver
from
submitting
a
replacement
acute
oral
study
using
the
TGAI
or
the
liquid
formulation
based
on
the
fact
that
the
new
formulants
found
in
Sporodex
L
are
of
food
grade
quality
and
that
the
levels
of
other
formulants
have
been
significantly
reduced.
The
toxicity
of
the
liquid
formulation
is,
therefore,
expected
to
be
less
than
that
of
the
wettable
powder
formulation
that
was
tested.
The
waiver
rationale
is
accepted.
The
acute
oral
study
is
classified
as
acceptable.
Based
on
the
results
of
this
study,
Sporodex
L
and
its
active
ingredient,
P.
flocculosa,
is
not
considered
toxic
or
pathogenic
to
male
or
female
Fisher
344
rats.
The
detection
of
P.
flocculosa
in
the
stomachs
and
small
intestines
of
some
of
the
treated
rats
is
consistent
with
the
route
of
administration.
Clearance
of
P.
flocculosa
appears
to
occur
within
seven
days
of
dosing.
I.
Deficiencies
The
number
of
air
changes
and
the
organ
weights
were
not
reported.
These
deficiencies
are
not
considered
to
have
a
significant
impact
on
the
interpretation
of
the
study.
Clearance
was
not
established
by
examining
the
feces
for
the
presence
of
P.
flocculosa.
This
is
not
considered
a
deficiency
since
clearance,
instead,
was
estimated
by
enumerating
P.
flocculosa
from
collected
tissues,
organs
and
fluids.
| epa | 2024-06-07T20:31:43.383275 | regulations | {
"license": "Public Domain",
"url": "https://downloads.regulations.gov/EPA-HQ-OPP-2002-0233-0013/content.txt"
} |
EPA-HQ-OPP-2002-0233-0014 | Supporting & Related Material | "2002-09-13T04:00:00" | null | [
Sporodex
L
/
2001
0304
/
PLG
]
~
PROTECTED
~
Acute
Dermal
Toxicity
/
Acute
Dermal
Irritation
/
1
[
Pseudozyma
flocculosa
/
2000
0680
/
STF]
DACO
M4.
4
and
M4.
5.
2
/
USEPA
OPPTS
885.3100
and
870.2500
Reviewer:
Esther
Seto
,
Date
February
1,
2002
Peer
Review:
Ibrahim
Barsoum,
PhD
Microbial
Pesticides
Branch
Biopesticides
and
Pollution
Prevention
Division
U.
S.
Environmental
Protection
Agency
_______________
STUDY
TYPE:
Acute
Dermal
Toxicity
Rabbit
PMRA
DATA
Code
M4.4
/
USEPA
OPPTS
885.3100
Acute
Dermal
Irritation
Rabbit
PMRA
DATA
Code
M4.5.
2
/
USEPA
OPPTS
870.2500
TEST
MATERIAL
(PURITY):
Sporothrix
flocculosa
(MPCA)
SYNONYMS:
Pseudozyma
flocculosa
[STF]
CITATION:
Johnson,
William
D.
(July
29,
1997).
"Acute
Dermal
Toxicity
/
Irritation
Study
of
Sporothrix
flocculosa,
a
Fungal
Pesticide,
in
Rabbits."
IIT
Research
Institute,
Life
Sciences
Department,
Chicago,
IL,
USA.
IITRI
Project
No.
L08641,
Study
No.
4.
InLife
Study
Dates:
November
13,
1996
November
27,
1996.
Unpublished.
SPONSOR:
Dr.
Richard
Bélanger
Université
Laval
Québec,
Canada
EXECUTIVE
SUMMARY:
In
an
acute
dermal
toxicity
study,
a
single
group
of
New
Zealand
White
rabbits
(5/
sex)
was
dermally
exposed
to
Sporothrix
flocculosa,
for
24
hours
to
an
area
of
approximately
10%
of
the
dorsal
skin
surface.
Following
exposure,
the
animals
were
observed
for
a
period
of
14
days.
Dermal
LD50
Males
>
1.2
x
10
7
CFU/
animal
(equivalent
to
approximately
0.82
0.90
g/
kg
bw)
Females
>
1.2
x
10
7
CFU/
animal
(equivalent
to
approximately
0.80
0.91
g/
kg
bw)
Combined
>
1.
2
x
10
7
CFU/
animal
(equivalent
to
approximately
0.
80
0.91
g/
kg
bw)
Limit
Dose.
No
mortalities
observed.
No
treatment
related
signs
of
toxicity
or
skin
irritation
were
observed
in
any
animal
during
the
14
day
observation
period.
At
the
dose
administered,
Sporothrix
flocculosa
is
not
considered
toxic
or
irritating
to
the
skin.
The
recommended
test
substance
for
acute
dermal
toxicity
and
acute
dermal
irritation
studies
is
the
end
use
product.
Instead,
the
test
substance
was
produced
by
the
test
facility
using
a
method
different
from
the
proposed
manufacturing
method.
A
waiver
rationale
was
submitted
to
address
the
toxicity
and/
or
irritation
potential
of
the
formulation
ingredients.
[
Sporodex
L
/
2001
0304
/
PLG
]
~
PROTECTED
~
Acute
Dermal
Toxicity
/
Acute
Dermal
Irritation
/
2
[
Pseudozyma
flocculosa
/
2000
0680
/
STF]
DACO
M4.
4
and
M4.
5.
2
/
USEPA
OPPTS
885.3100
and
870.2500
This
acute
dermal
study
is
classified
as
acceptable
for
assessing
the
dermal
toxicity
and
dermal
irritation
potential
of
Sporothrix
flocculosa,
the
MPCA
found
in
Sporodex
L.
COMPLIANCE:
Signed
and
dated
GLP
and
Quality
Assurance
statements
were
included.
A
Statement
of
No
Data
Confidentiality
was
provided
but
was
not
signed
or
dated.
I.
MATERIALS
AND
METHODS
A.
MATERIALS:
1.
Test
Material:
Sporothrix
flocculosa
Description:
MPCA
Lot/
Batch
#:
UK34
35
Purity:
1.1
x
10
7
cells/
mL
by
hemacytometer
count
6.2
x
10
6
CFU/
mL
by
plate
count
CAS
#
TGAI:
N/
A
Test
substance
homogeneity
was
determined
by
withdrawing
aliquots
from
three
locations
(top,
centre
and
bottom)
of
a
10
mL
tube
containing
test
substance
in
ASTM
type
1
water.
Samples
from
the
three
locations
were
plated
in
triplicate
on
YM
plates.
Colonies
were
counted
after
incubation
for
three
days
at
25
C.
The
average
plate
count
of
the
triplicate
samples
taken
from
each
location
was
comparable,
indicating
that
the
test
substance
was
homogeneous
throughout
the
volume
of
the
tube.
2.
Sample
Preparation:
Sporothrix
flocculosa
(batch
number
UK34
35)
was
provided
to
the
test
facility
in
the
form
of
two
petri
dishes
(P1
and
P2)
of
yeast
malt
agar
with
white
mould.
IITRI
then
inoculated
two
malt
agar
plates
(P3
and
P4)
with
a
colony
from
P1.
A
scrape
of
P4
culture
was
added
to
50
mL
of
YM
broth
and
incubated
at
room
temperature.
On
the
day
of
dosing,
the
YM
broth
containing
Sporothrix
flocculosa
was
filtered
through
sterile
gauze
pads
into
100
mL
of
sterile
ASTM
type
1
purified
water,
vortexed
and
administered
to
the
animals.
The
titre
of
the
dosing
suspension
was
determined
to
be
6.2
x
10
6
CFU/
mL
by
plate
count
(corresponding
to
1.
1
x
10
7
cells/
mL
by
hemactyometer
count).
3.
Test
animals:
Species:
Rabbit
Strain:
New
Zealand
White
Age/
weight
at
dosing:
approximately
2.
5
months
of
age
males:
2.22
2.
46
kg
females:
2.39
2.
50
kg
Source:
Kuiper
Rabbit
Ranch,
Gary,
IN,
USA
Housing:
The
rabbits
were
housed
individually
in
stainless
steel
cages
(61
x
45.5
x
41
cm)
with
absorbent
liners
placed
under
the
stainless
steel
mesh
floor
to
absorb
liquids.
Diet:
Each
animal
was
provided
with
150
g
of
Certified
Purina
Lab
Rabbit
Chow
HF
#
5326
(PMI
Feeds
Inc.,
St.
Louis,
MO)
daily.
Water:
City
of
Chicago
water
was
supplied
ad
libitum.
[
Sporodex
L
/
2001
0304
/
PLG
]
~
PROTECTED
~
Acute
Dermal
Toxicity
/
Acute
Dermal
Irritation
/
3
[
Pseudozyma
flocculosa
/
2000
0680
/
STF]
DACO
M4.
4
and
M4.
5.
2
/
USEPA
OPPTS
885.3100
and
870.2500
Environmental
conditions:
Temperature:
Humidity:
Air
changes:
Photoperiod:
22.5
23.0
C
40
56%
Not
Reported
12
hrs
dark
/
12
hrs
light
Acclimation
period:
The
animals
were
held
in
quarantine
for
1
week.
B.
STUDY
DESIGN
and
METHODS:
1.
In
life
dates
November
13,
1996
November
27,
1996.
2.
Animal
assignment
and
treatment
Five
rabbits
per
sex
were
randomly
selected
and
assigned
to
groups
as
summarized
in
Table
1.
Twentyfour
hours
prior
to
treatment,
fur
from
approximately
10%
of
the
dorsal
skin
surface
of
each
rabbit
was
clipped.
A
total
of
2
mL
of
the
test
substance
was
applied
to
the
prepared
skin
of
each
rabbit.
The
test
sites
were
covered
with
12.
8
x
11.
5
cm
surgical
dressing
(Surgipad,
J&
J
Products,
New
Brunswick,
NJ),
plastic
film,
lint
free
cloth
and
elastic
adhesive
bandage
(Elastoplast,
Beiersdorf
Inc.
k
Nowalk,
CT).
The
wrappings
were
removed
after
24
hours
and
the
application
sites
were
rinsed
with
water
and
towel
dried.
TABLE
1.
Doses,
mortality/
animals
treated
Dose
Males
Females
Combined
1.2
x
10
7
CFU/
animal
0/
5
0/
5
0/
10
3.
Clinical
Observations
All
rabbits
were
observed
frequently
immediately
following
dosing
and
once
per
day
for
13
days
after
removal
of
the
wrappings.
Clinical
observations
included
the
examination
of
the
application
site
for
signs
of
dermal
irritation
approximately
30
60
minutes
after
unwrapping
and
daily
thereafter.
Any
skin
reactions
observed
were
graded
according
to
the
Draize
method
(see
Appendix
1).
4.
Body
Weights
All
rabbits
were
weighed
prior
to
dosing
and
weekly
thereafter.
5.
Necropsies
At
the
end
of
the
study,
all
rabbits
were
euthanized
and
discarded
without
necropsy.
6.
Statistics
The
dermal
LD50
was
set
at
greater
than
1.
2
x
10
7
CFU/
animal.
No
calculations
were
required.
II.
RESULTS
AND
DISCUSSION:
A.
Mortality
[
Sporodex
L
/
2001
0304
/
PLG
]
~
PROTECTED
~
Acute
Dermal
Toxicity
/
Acute
Dermal
Irritation
/
4
[
Pseudozyma
flocculosa
/
2000
0680
/
STF]
DACO
M4.
4
and
M4.
5.
2
/
USEPA
OPPTS
885.3100
and
870.2500
None
of
the
rabbits
died
during
the
course
of
the
study.
The
dermal
LD50
is
greater
than
1.
2
x
10
7
CFU/
animal
for
both
male
and
female
rabbits.
B.
Clinical
observations
One
male
rabbit
exhibited
slight
diarrhea
7
days
following
unwrapping.
No
other
adverse
clinical
symptoms
were
observed
during
the
treatment
and
observation
period.
No
signs
of
dermal
irritation
(i.
e.,
erythema
or
edema)
were
observed
in
any
rabbit
upon
removal
of
the
wrappings
or
during
the
subsequent
observation
period.
C.
Body
Weight
Individual
body
weight
data
are
summarized
in
Table
2.
One
male
rabbit
lost
weight
within
the
first
week
but
experienced
a
slight
weight
gain
thereafter.
TABLE
2.
Body
Weight
Males
Body
Weight
(kg)
Animal
Number
Week
0
Week
1
Week
2
Cumulative
Body
Weight
Change
(kg)
(week
2
week
0)
981
2.45
2.61
2.71
0.26
982
2.38
2.49
2.72
0.34
983
2.22
2.40
2.58
0.36
985
2.34
2.32
2.35
0.01
Mean
2.36
2.49
2.62
0.27
±S.
D.
a
0.09
0.14
0.17
0.15
Females
Body
Weight
(kg)
Animal
Number
Week
0
Week
1
Week
2
Cumulative
Body
Weight
Change
(kg)
(week
2
week
0)
986
2.50
2.64
2.78
0.28
987
2.20
2.46
2.62
0.42
988
2.39
2.60
2.69
0.28
989
2.41
2.60
2.69
0.28
990
2.46
2.60
2.79
0.33
Mean
2.39
2.58
2.71
0.32
[
Sporodex
L
/
2001
0304
/
PLG
]
~
PROTECTED
~
Acute
Dermal
Toxicity
/
Acute
Dermal
Irritation
/
5
[
Pseudozyma
flocculosa
/
2000
0680
/
STF]
DACO
M4.
4
and
M4.
5.
2
/
USEPA
OPPTS
885.3100
and
870.2500
±
S.
D.
0.
12
0.
07
0.
07
0.
06
a
S.
D.
standard
deviation
E.
Reviewer's
Conclusions
The
recommended
test
substance
for
acute
dermal
toxicity
and
acute
dermal
irritation
studies
is
the
end
use
product.
Instead,
the
test
substance
was
produced
by
the
test
facility
using
a
method
different
from
the
proposed
manufacturing
method.
A
waiver
rationale
was
submitted
to
address
the
toxicity
and/
or
irritation
potential
of
the
formulation
ingredients.
All
formulation
ingredients
are
either
food
grade
or
relatively
nontoxic
One
formulation
ingredient
may
cause
irritation
of
the
skin
with
prolonged
contact.
The
LD50
for
Sporothrix
flocculosa,
the
MPCA
in
Sporodex
L,
in
male
and
female
rats
is
greater
than
1.
2
x
10
7
CFU/
animal.
No
treatment
related
signs
of
toxicity
or
skin
irritation
were
observed
in
any
animal
during
the
14
day
observation
period.
F.
Deficiencies
The
number
of
air
changes
per
hour
was
not
reported.
However,
given
the
data
presented,
this
omission
is
considered
to
have
no
impact
on
the
interpretation
of
the
study
results.
[
Sporodex
L
/
2001
0304
/
PLG
]
~
PROTECTED
~
Acute
Dermal
Toxicity
/
Acute
Dermal
Irritation
/
6
[
Pseudozyma
flocculosa
/
2000
0680
/
STF]
DACO
M4.
4
and
M4.
5.
2
/
USEPA
OPPTS
885.3100
and
870.2500
Appendix
1:
Description
of
Skin
Reactions
Evaluation
of
Skin
Reactions
Score
Erythema
and
eschar
formation
No
erythema
0
Very
slight
erythema
(barely
perceptible)
1
Well
defined
erythema
2
Moderate
to
severe
erythema
3
Severe
erythema
(beet
redness)
to
slight
4
eschar
formation
(injuries
in
depth)
Edema
Formation
No
edema
0
Very
slight
edema
(barely
perceptible)
1
Slight
edema
(edges
of
area
well
defined
2
by
definite
raising)
Moderate
edema
(raised
approximately
3
1.
0
mm)
Severe
edema
(raised
more
than
1.
0
mm
4
beyond
the
area
of
exposure)
Draize,
J.
H.,
Appraisal
of
the
Safety
of
Chemicals
in
Foods,
Drugs,
and
Cosmetics,
Assoc.
Food
and
Drug
Officials
of
the
U.
S.,
Austin,
Texas,
1959.
| epa | 2024-06-07T20:31:43.388235 | regulations | {
"license": "Public Domain",
"url": "https://downloads.regulations.gov/EPA-HQ-OPP-2002-0233-0014/content.txt"
} |
EPA-HQ-OPP-2002-0233-0015 | Supporting & Related Material | "2002-09-13T04:00:00" | null | [
Sporodex
L
/
2001
0304
/
PLG
]
~
PROTECTED
~
Food
and
Feed
Residue
Studies
/
1
[
Pseudozyma
flocculosa
/
2000
0680
/
STF]
DACO
M7
Reviewer:
Esther
Seto
,
Date
February
8,
2002
Peer
Review:
Ibrahim
Barsoum,
PhD
Microbial
Pesticides
Branch
Biopesticides
and
Pollution
Prevention
Division
U.
S.
Environmental
Protection
Agency
_______________
STUDY
TYPE:
Food
and
Feed
Residue
Studies
PMRA
DATA
CODE
M7
TEST
MATERIAL
(PURITY):
Sporodex
L
SYNONYMS:
Pseudozyma
flocculosa,
Sporothrix
flocculosa,
STF
REVIEWER'S
COMMENTS
AND
CONCLUSION:
According
to
its
proposed
use
pattern,
Sporodex
L
will
be
applied
by
foliar
spray
to
rose
and
cucumber
plants.
An
extensive
literature
search
yielded
no
reports
of
mammalian
toxins
being
produced
by
Pseudozyma
flocculosa
(see
Part
M2
review).
The
fungitoxic
unsaturated
C
17
fatty
acids
and
acyclic
norterpene
produced
by
the
MPCA
have
not
been
reported
to
be
toxic
to
mammals.
Neither
this
organism
nor
its
close
relatives
are
listed
among
microbial
contaminants
of
food
(Bakalinski
1992).
In
an
acute
oral
toxicity
study
(see
review
for
Part
M4.2.2),
groups
of
fasted,
6
7
week
old
Fisher
344
rats
(12/
sex)
were
given
a
single
oral
dose
of
Sporodex
WP
(an
alternative
end
use
formulation
of
Pseudozyma
flocculosa)
in
USP
sterile
water
for
injection
at
doses
of
5.
8
x
10
8
colony
forming
units
(CFU)
per
animal
for
males
and
5.
6
x
10
8
CFU
per
animal
for
females.
The
animals
were
then
observed
for
a
period
of
up
to
21
days
with
interim
scheduled
sacrifices.
No
mortalities
occurred.
There
were
no
clinical
signs
of
toxicity
and
all
of
the
animals
gained
weight
during
the
study.
No
gross
findings
were
observed
at
necropsy.
Pseudozyma
flocculosa
was
classified
as
being
of
LOW
Toxicity
based
on
the
LD50
in
female
Fisher
344
rats.
Based
on
the
results
of
the
acute
oral
toxicity
study
and
the
absence
of
reports
of
mammalian
toxin
production,
the
establishment
of
a
maximum
residue
limit
is
not
required
for
Pseudozyma
flocculosa
under
section4(
d)
of
theFood
and
Drugs
Act
(adulteration
of
food)
as
defined
under
Division
15,
Section
B15.
002
of
the
Food
and
Drugs
Regulations.
[
Sporodex
L
/
2001
0304
/
PLG
]
~
PROTECTED
~
Food
and
Feed
Residue
Studies
/
2
[
Pseudozyma
flocculosa
/
2000
0680
/
STF]
DACO
M7
Literature
Cited
Bakalinski,
A.
T.
(1992)
Food
Biopreservatives
of
Microbial
Origin.
Chapter
12:
347
371.
| epa | 2024-06-07T20:31:43.391258 | regulations | {
"license": "Public Domain",
"url": "https://downloads.regulations.gov/EPA-HQ-OPP-2002-0233-0015/content.txt"
} |
EPA-HQ-OPP-2002-0233-0016 | Supporting & Related Material | "2002-09-13T04:00:00" | null | [
Sporodex
L
/
2001
0304
/
PLG
]
~
PROTECTED
~
Reporting
of
Hypersensitivity
Incidence
/
1
[
Pseudozyma
flocculosa
/
2000
0680
/
STF]
DACO
M4.
6
/
USEPA
OPPTS
885.3400
Reviewer:
Esther
Seto
,
Date
February
12,
2002
Peer
Review:
Ibrahim
Barsoum,
PhD
Microbial
Pesticides
Branch
Biopesticides
and
Pollution
Prevention
Division
U.
S.
Environmental
Protection
Agency
_______________
STUDY
TYPE:
Reporting
of
Hypersensitivity
Incidence
PMRA
DATA
CODE
M4.6
/
USEPA
OPPTS
885.3400
TEST
MATERIAL
(PURITY):
Sporodex
L
SYNONYMS:
Pseudozyma
flocculosa,
Sporothrix
flocculosa,
STF
CITATION:
Hale,
J.
(January
24,
2000).
"Sporodex
WP
Reporting
of
Hypersensitivity."
Plant
Products
Co.
Ltd,
Bramptom,
Ontario.
Unpublished.
SPONSOR:
Plant
Products.
Co.
Ltd.
Bramptom,
Ontario
EXECUTIVE
SUMMARY:
No
adverse
effects
have
been
noted
among
researchers
who
have
worked
closely
with
Pseudozyma
flocculosa
for
up
to
10
years.
The
applicant
has
submitted
a
waiver
rationale
from
conducting
a
dermal
sensitization
study
based
on
the
assumption
that
most
microorganisms
contain
substances
that
could
elicit
a
hypersensitivity
response.
Pseudozyma
flocculosa
is
considered
a
potential
sensitizing
agent,
therefore,
the
statement,
"POTENTIAL
SENSITIZER"
is
required
on
the
primary
display
panel
of
the
label.
Also,
if
registration
is
granted,
all
incidents
of
hypersensitivity
occurring
after
registration
must
be
reported.
| epa | 2024-06-07T20:31:43.393804 | regulations | {
"license": "Public Domain",
"url": "https://downloads.regulations.gov/EPA-HQ-OPP-2002-0233-0016/content.txt"
} |
EPA-HQ-OPP-2002-0233-0017 | Supporting & Related Material | "2002-09-13T04:00:00" | null | [
Sporodex
L
/
2001
0304
/
PLG
]
~
PROTECTED
~
Exposure
Assessment
/
1
[
Pseudozyma
flocculosa
/
2000
0680
/
STF]
DACO
M5
Reviewer:
Esther
Seto
,
Date
February
11,
2002
Peer
Review:
Ibrahim
Barsoum,
PhD
Microbial
Pesticides
Branch
Biopesticides
and
Pollution
Prevention
Division
U.
S.
Environmental
Protection
Agency
_______________
STUDY
TYPE:
Exposure
Assessment
PMRA
DATA
CODE
M5
TEST
MATERIAL
(PURITY):
Sporodex
L
SYNONYMS:
Pseudozyma
flocculosa,
Sporothrix
flocculosa
REVIEWER'S
COMMENTS
AND
CONCLUSION:
Proposed
Use
Pattern
The
proposed
use
of
Sporodex
L
is
as
a
foliar
spray
on
roses
and
cucumbers
grown
in
greenhouse
environments
(use
site
categories
#5
and
#6).
According
to
the
draft
label,
up
to
7.
5
L
of
Sporodex
L
(diluted
with
water
up
to
1500
L)
will
be
applied
to
one
hectare
of
cut
roses
or
cucumbers
and
up
to
5.
0
L
of
Sporodex
L
(diluted
with
water
up
to
1000
L)
will
be
applied
to
one
hecatre
of
potted
plants.
Application
of
Sporodex
L
is
recommended
to
begin
when
environmental
conditions
favour
development
of
powdery
mildew,
or
at
the
first
sign
of
disease,
followed
by
weekly
treatments
thereafter.
When
handled
according
to
the
label
instructions,
the
oral,
pulmonary,
dermal
and
ocular
routes
are
potential
routes
of
applicator
and
bystander
exposure.
Occupational
exposure
is
of
particular
concern
as
the
product
will
be
used
in
an
enclosed
environment.
Toxicological
and
Pathogenicity
Profile
An
extensive
literature
search
yielded
no
reports
of
mammalian
toxins
being
produced
by
Pseudozyma
flocculosa
(see
Part
M2
review).
The
fungitoxic
unsaturated
C
17
fatty
acids
and
acyclic
norterpene
produced
by
the
MPCA
have
not
been
reported
to
be
toxic
to
mammals.
According
to
the
toxicological
information
submitted
under
Part
M4
Human
Health
and
Safety
Testing,
Sporothrix
flocculosa
(now
termed
Pseudozyma
flocculosa)
was
not
toxic
or
pathogenic
to
Fisher
344
rats
following
oral
gavage
of
Sporodex
WP
(an
alternative
end
use
formulation)
at
a
dose
of
5.
8
x
10
8
CFU/
animal.
Exposure
via
intraperitoneal
injection
of
3.
5
x
10
7
CFU/
animal
indicated
that
S.
flocculosa
was
of
slight
toxicity
(due
to
decreased
body
weight
gain
coupled
with
increased
food
consumption
of
treated
male
rats)
but
was
not
pathogenic.
No
signs
of
dermal
irritation
or
dermal
toxicity
were
noted
in
rabbits
after
dermal
exposure
to
Sporodex
WP.
Slight
ocular
irritation
was
observed
up
to
24
hours
after
exposure
to
Sporodex
WP,
but
all
signs
of
irritation
subsided
by
the
48
hour
scoring
interval.
Sporodex
L
is
expected
to
be
less
irritating,
than
Sporodex
WP,
to
the
skin
and
eyes
due
to
the
reduction
of
an
irritating
[
Sporodex
L
/
2001
0304
/
PLG
]
~
PROTECTED
~
Exposure
Assessment
/
2
[
Pseudozyma
flocculosa
/
2000
0680
/
STF]
DACO
M5
component
of
the
final
formulation.
The
acute
pulmonary
toxicity/
infectivity
study
was
not
acceptable
due
to
a
large
number
of
deaths
in
the
treatment
and
control
groups,
likely
due
to
improper
dosing
technique.
A
subsequent
range
finding
study
indicated
that
S.
flocculosa
was
not
toxic
at
doses
of
up
to
4.
2
x
10
7
CFU/
animal.
This
study,
however,
was
considered
supplemental
because
the
highest
dose
administered
was
below
the
minimum
dose
required
of
10
8
CFU/
animal
and
because
infectivity/
pathogenicity
was
not
addressed.
Occupational
Exposure
and
Risk
Characterization
The
Agency
does
not
expect
that
occupational
exposures
will
pose
an
undue
risk
on
the
basis
of
the
low
toxicity/
pathogenicity
profile.
While
submitted
acute
pulmonary
toxicity/
infectivity
studies
were
found
to
be
lacking,
inhalation
exposure
is
not
of
concern
if
the
required
respirator
is
also
worn
by
workers.
To
mitigate
dermal
and
inhalation
exposure
and
risk
to
workers,
use
of
appropriate
Personal
Protective
Equipment
(PPE)
will
be
required
as
described
under
the
Labelling
Statements
section,
below.
Assuming
that
most
microorganisms
contain
substances
that
would
elicit
positive
hypersensitivity
reactions,
P.
flocculosa
is
considered
a
potential
sensitizing
agent,
and
a
"POTENTIAL
SENSITIZER"
statement
will
be
required
on
the
principal
display
panel
of
the
TGAI
and
end
use
formulation
labels.
Non
Occupational
Exposure
and
Risk
Characterization
The
label
does
not
allow
applications
to
turf,
residential
or
recreational
areas.
Because
the
use
sites
are
in
greenhouses,
exposure
to
infants
and
children
in
school,
residential
and
daycare
facilities
is
likely
to
be
minimal
to
non
existent.
Consequently,
the
health
risk
to
infants
and
children
is
expected
to
be
negligible
to
nonexistent.
Labelling
Statements
Given
the
potential
for
sensitization
and
for
worker
inhalation
and
dermal
exposure
it
is
recommended
that
the
Sporodex
L
label
include
the
following
signal
words
and
precaution
and
first
aid
statements:
Principal
Display
Panel:
"POTENTIAL
SENSITIZER"
Secondary
Display
Panel:
"PRECAUTIONS
May
cause
sensitization.
Avoid
contact
with
skin
and
eyes
or
clothing.
Avoid
breathing
mist.
Workers
and
handlers
(includes
mixer/
loader,
applicators,
and
early
entry
workers)
must
wear
a
long
sleeved
shirt,
long
pants,
shoes
plus
socks,
waterproof
gloves
and
a
NIOSH
approved
respirator
with
any
N
95,
R
95,
P
95
or
HE
filter
for
biological
products
when
mixing/
loading
or
applying
the
product
and
during
all
clean
up/
repair
activities.
Workers
wearing
appropriate
PPE
can
enter
treated
areas
during
the
restricted
entry
interval
(REI)
of
4
hours.
Wash
thoroughly
with
soap
and
water
after
handling.
Remove
contaminated
clothing
and
follow
manufacturers
directions
[
Sporodex
L
/
2001
0304
/
PLG
]
~
PROTECTED
~
Exposure
Assessment
/
3
[
Pseudozyma
flocculosa
/
2000
0680
/
STF]
DACO
M5
for
cleaning/
maintaining
personal
protective
equipment
(PPE)
before
reuse.
If
no
such
instructions
are
available
use
clothing
detergent
and
hot
water
for
cleaning
all
washable
PPE.
Keep
and
wash
PPE
separately
from
other
laundry.
FIRST
AID
IF
ON
SKIN/
CLOTHING
Take
off
contaminated
clothing.
Rinse
skin
immediately
with
plenty
of
water.
IF
IN
EYES
Hold
eye
open
and
rinse
slowly
and
gently
with
water.
Remove
contact
lenses,
if
present,
then
continue
rinsing
eye.
GENERAL
Seek
medical
attention
immediately
if
irritation
occurs
and
persists
or
is
severe.
Take
container,
label
or
product
name
and
Pest
Control
Product
Registration
Number
with
you
when
seeking
medical
attention."
| epa | 2024-06-07T20:31:43.396279 | regulations | {
"license": "Public Domain",
"url": "https://downloads.regulations.gov/EPA-HQ-OPP-2002-0233-0017/content.txt"
} |
EPA-HQ-OPP-2002-0233-0018 | Supporting & Related Material | "2002-09-13T04:00:00" | null | [
Sporodex
L
/
2001
0304
/
PLG
]
~
PROTECTED
~
Intraperitoneal
Infectivity
Study
/
1
[
Pseudozyma
flocculosa
/
2000
0680
/
STF]
DACO
M4.
3.
3
Reviewer:
Esther
Seto
,
Date
January,
29,
2002
Peer
Review:
Ibrahim
Barsoum,
PhD
Microbial
Pesticides
Branch
Biopesticides
and
Pollution
Prevention
Division
U.
S.
Environmental
Protection
Agency
_______________
STUDY
TYPE:
Intraperitoneal
Infectivity
Study
Rat
PMRA
DATA
CODE
M4.3.
3
/
USEPA
OPPTS
885.3200
TEST
MATERIAL
(PURITY):
Sporothrix
flocculosa
(pure
culture)
1.44
x
10
6
CFU/
mL
SYNONYMS:
Pseudozyma
flocculosa
[STF]
CITATION:
Harrington,
Kelly
A.
(June
19,
1997).
"Acute
Intraperitoneal
Infectivity
Testing
of
Sporothrix
flocculosa,
a
Fungal
Pesticide."
IIT
Research
Institute,
Life
Sciences
Department,
Chicago,
Illinois,
USA.
IITRI
Project
No.
L08641.
Study
No.
2.
In
Life
Dates:
October
17,
1996
October
31,
1996.
SPONSOR:
Dr.
Richard
Bélanger
Université
Laval
Québec,
Canada
EXECUTIVE
SUMMARY:
In
an
acute
intraperiteonal
toxicity/
infectivity
study,
groups
of
young
adult
CD
rats
(4/
sex/
scheduled
sacrifice
date)
were
exposed
by
the
intraperitoneal
route
to
an
undiluted
suspension
of
Sporothrix
flocculosa
(TS)
at
a
dose
of
3.
5
x
10
7
cfu/
animal
(in
1.
0
mL).
Animals
were
then
observed
for
up
to
14
days.
An
equal
number
of
young
adult
CD
rats
were
similarly
injected
with
heatkilled
test
substance
(KTS).
An
undosed
naive
control
(NC)
group
consisting
of
4
rats/
sex
was
also
included
in
the
study.
Cage
side
observations
for
clinical
symptoms
was
performed
daily
and
animal
body
weights
and
food
consumption
were
monitored.
No
unscheduled
deaths
occurred.
Designated
animals
from
the
TS
and
KTS
groups
were
sacrificed
on
days
0,
7
and
14
and
gross
necropsies
were
performed.
The
NC
group
of
animals
was
sacrificed
and
necropsied
at
the
end
of
the
14
day
study.
Infectivity
and
clearance
were
assessed
by
quantitatively
recovering
the
MPCA
from
the
blood,
lungs
and
lymph
nodes,
spleen,
kidneys,
liver,
heart,
stomach
and
small
intestine,
peritoneal
fluid,
caecum
and
brain.
No
adverse
clinical
signs
were
observed
at
any
point
of
the
study
in
any
of
the
groups
of
rats.
Body
weight
gain
of
TS
dosed
male
rats
was
significantly
decreased
while
this
group's
food
consumption
was
significantly
increased
compared
to
NC
animals.
There
was
no
significant
difference
between
KTS
dosed
and
NC
animals
in
terms
of
body
weight,
body
weight
gain
or
food
consumption.
Upon
necropsy
of
TSand
KTS
dosed
animals,
white
nodules
and
higher
relative
spleen
weights
were
observed
and
attributed
to
a
[
Sporodex
L
/
2001
0304
/
PLG
]
~
PROTECTED
~
Intraperitoneal
Infectivity
Study
/
2
[
Pseudozyma
flocculosa
/
2000
0680
/
STF]
DACO
M4.
3.
3
normal
immune
response
to
a
foreign
substance.
The
detection
of
S.
flocculosa
in
the
peritoneal
fluid
lavage
of
TS
dosed
male
rats
was
consistent
with
the
method
of
administration.
Clearance
of
S.
flocculosa
from
all
other
tissues
and
fluids
occurred
by
day
7.
No
test
substance
was
detected
from
any
of
the
organs
of
the
KTS
dosed
or
NC
animals.
At
the
dose
administered,
S.
flocculosa
is
slightly
toxic
but
not
pathogenic
to
male
and
female
CD
rats
when
introduced
by
the
intraperitoneal
route.
This
acute
intraperitoneal
toxicity/
infectivity
study
is
classified
as
acceptable.
COMPLIANCE:
Signed
and
dated
GLP
and
QA
statements
were
provided.
A
No
Data
Confidentiality
Claims
statement
was
included
but
was
not
signed
or
dated.
I.
MATERIALS
AND
METHODS
A.
MATERIALS:
1.
Test
Material:
Sporothrix
flocculosa
Description:
MPCA
Lot/
Batch
#:
UK34
35
Purity:
CAS
#:
N/
A
Test
substance
homogeneity
was
determined
by
withdrawing
aliquots
from
three
locations
(top,
centre
and
bottom)
of
a
10
mL
tube
containing
test
substance
in
ASTM
type
1
water.
Samples
from
the
three
locations
were
plated
in
triplicate
on
YM
plates.
Colonies
were
counted
after
incubation
for
three
days
at
25
C.
The
average
plate
count
of
the
triplicate
samples
taken
from
each
location
was
comparable,
indicating
that
the
test
substance
was
homogeneous
throughout
the
volume
of
the
tube.
2.
Sample
Preparation:
Sporothrix
flocculosa
(batch
number
UK34
35)
was
provided
to
the
test
facility
in
the
form
of
two
petri
dishes
(P1
and
P2)
of
yeast
malt
agar
with
white
mould.
IITRI
then
inoculated
two
malt
agar
plates
(P3
and
P4)
with
a
colony
from
P1.
One
week
prior
to
dosing
in
the
preliminary
challenge
assay
component
of
the
study,
300
mL
of
yeast
malt
broth
was
inoculated
with
test
substance
from
P4
and
incubated
at
room
temperature
for
seven
days.
On
the
day
of
dosing,
the
broth
culture
was
centrifuged
and
the
pellet
was
resuspended
in
5
mL
of
ASTM
Type
1
water.
The
titre
of
the
resuspended
solution
was
determined
to
be
1.
44
x
10
6
cfu/
mL
by
plate
count
(corresponding
to
9.
38
x
10
6
cells/
mL
by
hemacytometer
count).
This
solution
was
used
undiluted
for
dosing.
One
week
before
the
start
of
the
actual
infectivity
study,
300
mL
of
yeast
malt
broth
was
inoculated
with
test
substance
from
P4
and
incubated
at
room
temperature
for
seven
days.
On
the
day
of
dosing,
the
broth
culture
was
centrifuged
and
resuspended
in
7
mL
of
ASTM
Type
1
water.
The
titre
of
the
solution
was
adjusted
to
1
x
10
7
cells/
mL
(by
hemacytometer
count)
and
was
then
divided
into
two
aliquots.
One
aliquot
was
heat
treated
for
20
minutes
at
approximately
82
C
to
render
the
active
ingredient
non
viable
and
was
used
as
KTS
(killed
test
substance).
The
second
aliquot
was
used
as
TS
(test
substance).
Both
KTS
and
TS
were
plated
to
verify
titre
and
inactivation,
respectively.
The
titre
of
the
TS
solution
was
3.5
x
10
7
cfu/
mL
and
the
titre
of
the
KTS
solution
was
0
cfu/
mL.
[
Sporodex
L
/
2001
0304
/
PLG
]
~
PROTECTED
~
Intraperitoneal
Infectivity
Study
/
3
[
Pseudozyma
flocculosa
/
2000
0680
/
STF]
DACO
M4.
3.
3
3.
Test
animals:
Species:
Rat
Strain:
Outbred
Sprague
Dawley
strain,
i.
e.,
CD
Age/
weight
at
dosing:
Preliminary
Challenge:
Males:
49
to
51
days
old,
weights
were
not
reported
Females:
49
to
51
days
old,
weights
were
not
reported
Actual
Study:
Males:
56
to
58
days
old,
244.88
288.30
g
Females:
56
to
58
days
old,
184.7
213.16
g
Source:
Charles
River
Laboratories,
Portage,
MI,
USA.
Housing:
Rats
were
housed
up
to
two
per
cage
in
polypropylene
cages
with
hardwood
chip
bedding.
Animals
in
the
naive
control
and
killed
test
substance
dosed
groups
were
housed
in
one
room
while
test
substance
dosed
groups
were
housed
in
a
second
room.
Diet:
Certified
Purina
Rodent
Chow
5002
(PMI
Feeds,
Inc.,
St.
Louis,
MI,
USA)
was
provided
ad
libitum.
Water:
City
of
Chicago
water
was
provided
ad
libitum.
Environmental
conditions:
Temperature:
Humidity:
Air
changes:
Photoperiod:
18
25
C
13
70%
Not
Reported
12
hrs
dark
/
12
hrs
light
Acclimation
period:
Preliminary
Challenge:
1
week
Actual
Study:
2
weeks
B.
STUDY
DESIGN
and
METHODS:
1.
In
life
dates
Start:
Preliminary
Challenge
October
9,
1996
End:
Preliminary
Challenge
October
14,
1996
Actual
Study
October
17,
1996
Actual
Study
October
31,
1996
2.
Preliminary
Challenge
Assay
A
preliminary
assay
was
conducted
to
assess
the
toxicity
potential
of
the
test
substance.
The
preliminary
assay
was
initiated
by
administering
the
test
substance
to
three
male
and
three
female
CD
rats
by
intraperitoneal
injection
at
a
dose
of
1.
44
x
10
6
cfu
(9.
38
x
10
6
cells)
in
a
1
mL
dose
per
animal.
Following
treatment,
the
animals
were
observed
for
5
days.
All
animals
survived
and
no
clinical
symptoms
were
observed.
3.
Experimental
Design
Test
animals
were
weighed
and
assigned
to
treatment
groups
such
that
no
animal's
body
weight
varied
from
the
group
mean
body
weight
by
more
than
20%.
Treatment
groups
were
created
according
to
the
treatment
received;
i)
test
substance
(TS),
ii)
killed
test
substance
(KTS),
iii)
no
treatment
or
a
naive
control
group
(NC).
The
number
of
animals
and
the
sacrifice
time
for
each
of
the
test
groups
is
shown
in
Table
1.
TABLE
1.
Treatment,
mortality/
animals
treated
Treatment
Scheduled
Sacrifice
Mortality
(#
dead/
total)
Males
Females
Combined
[
Sporodex
L
/
2001
0304
/
PLG
]
~
PROTECTED
~
Intraperitoneal
Infectivity
Study
/
4
[
Pseudozyma
flocculosa
/
2000
0680
/
STF]
DACO
M4.
3.
3
TS
a
0
0/
4
0/
4
0/
8
KTS
b
0
0/
4
0/
4
0/
8
TS
a
7
0/
4
0/
4
0/
8
KTS
b
7
0/
4
0/
4
0/
8
TS
a
14
0/
4
0/
4
0/
8
KTS
b
14
0/
4
0/
4
0/
8
NC
c
14
0/
4
0/
4
0/
8
a
dosed
with
1
mL
of
TS
containing
3.
5
x
10
7
cfu
of
S.
flocculosa
b
dosed
with
1
mL
of
KTS
containing
the
equivalent
of
3.2
x
10
7
cfu
of
heat
killed
S.
flocculosa
per
animal
c
naive
control
group
4.
Body
Weights
Animal
body
weights
were
determined
upon
receipt
(random
sample
of
10
animals/
sex),
prior
to
randomization,
at
the
time
of
dosing
(day
0),
and
on
days
7
and
14.
5.
Clinical
Observations
Clinical
observations
were
recorded
daily.
6.
Food
Consumption
Average
daily
food
consumption
per
rat
was
calculated.
7.
Necropsy
Test
animals
were
sacrificed
according
to
Table
1.
Necropsies
consisting
of
body
and
organ
weight
measurements
and
examinations
of
the
external
features,
internal
organs
and
cavities
were
performed.
8.
Microbial
Enumeration
Samples
of
blood,
brain,
caecum,
heart,
kidneys,
liver,
lungs
and
lymph
nodes,
mesenteric
lymph
nodes,
peritoneal
fluid,
spleen,
and
stomach
with
small
intestines
were
aseptically
removed
and
placed
in
sterile
blending
bags
containing
0.
1%
peptone.
The
tissues
were
blended
and
aliquots
were
serially
diluted
in
0.
1
%
peptone
and
plated
onto
duplicate
plates
of
YM
or
MA
(see
study
for
determining
sensitivity
of
detection).
The
plates
were
incubated
for
91
94
hours
at
approximately
25
C.
Mean
counts
from
the
duplicate
plates
were
reported
as
viable
cfu/
mL
or
cfu/
g.
9.
Statistics
a)
Body
Weights
and
Food
Consumption
The
mean
and
standard
deviation
in
body
weight
and
average
daily
food
consumption
were
calculated
for
each
treatment
group
by
sex.
The
data
were
log
transformed
and
statistically
compared
for
treatment
[
Sporodex
L
/
2001
0304
/
PLG
]
~
PROTECTED
~
Intraperitoneal
Infectivity
Study
/
5
[
Pseudozyma
flocculosa
/
2000
0680
/
STF]
DACO
M4.
3.
3
group
by
analysis
of
variance
(ANOVA)
followed,
where
appropriate,
by
Dunnett's
test.
A
p
0.05
was
considered
significant.
b)
Organ
Weights
Group
mean
and
standard
deviation
of
relative
organ
weights
(%
of
total
weight)
were
calculated
for
day
14
data
only.
The
log
transformed
data
were
statistically
compared
by
treatment
group
by
ANOVA
followed,
where
appropriate,
by
Dunnett's
test.
A
p
0.
05
was
considered
significant.
c)
Microbial
Enumeration
Since
the
test
substance
was
recovered
only
fromTS
dosed
animals
and
only
on
day
0,
no
statistical
analyses
were
performed.
II.
RESULTS
AND
DISCUSSION:
A.
Mortality
No
deaths
occurred
during
the
study.
B.
Clinical
Observations
No
adverse
clinical
symptoms
were
observed
in
any
of
the
animals
during
the
course
of
the
study.
C.
Body
Weights
and
Body
Weight
Gains
Body
weights
and
body
weight
gains
are
shown
in
Tables
2
and
3,
respectively.
No
significant
differences
between
the
treated
groups
and
control,
with
respect
to
body
weight,
were
observed.
Total
body
weight
gain
and
body
weight
gain
in
male
TS
dosed
animals
on
day
7,
however,
were
significantly
decreased
compared
to
controls.
Table
2.
Effect
of
Intraperitoneal
Administration
of
Sporothrix
flocculosa
on
Body
Weights
of
Rats
Group
Sex
Parameter
Body
Weight
(g)
Day
0
Day
7
Day
14
TS
M
Mean
StDev
No.
rats
263.65
14.220
12
301.74
19.625
8
309.64
21.810
4
KTS
M
Mean
StDev
No.
rats
265.64
9.9196
12
315.45
10.618
8
332.67
4.296
4
NC
M
Mean
StDev
No.
rats
259.86
12.142
4
310.92
17.580
4
324.54
14.226
4
[
Sporodex
L
/
2001
0304
/
PLG
]
~
PROTECTED
~
Intraperitoneal
Infectivity
Study
/
6
[
Pseudozyma
flocculosa
/
2000
0680
/
STF]
DACO
M4.
3.
3
Group
Sex
Parameter
Body
Weight
(g)
Day
0
Day
7
Day
14
TS
F
Mean
StDev
No.
rats
200.06
8.889
12
220.42
9.548
8
232.59
10.399
4
KTS
F
Mean
StDev
No.
rats
200.57
7.653
12
221.44
12.222
8
234.20
14.497
4
NC
F
Mean
StDev
No.
rats
198.77
7.550
4
218.49
11.458
4
230.61
12.375
4
TABLE
3.
Effect
of
Intraperitoneal
Administration
of
Sporothrix
flocculosa
on
Body
Weight
Gains
of
Rats
Group
Sex
Parameter
Body
Weight
Gain
(g)
Day
0
7
Day
7
14
TotalGain
TS
M
Mean
StDev
No.
rats
39.71*
7.081
8
6.58
7.345
4
44.77*
8.942
4
KTS
M
Mean
StDev
No.
rats
45.92
6.353
8
11.04
3.640
4
60.08
4.491
4
NC
M
Mean
StDev
No.
rats
51.06
6.562
4
13.62
10.993
4
64.68
9.753
4
TS
F
Mean
StDev
No.
rats
20.86
6.959
8
8.83
1.749
4
33.52
6.635
4
KTS
F
Mean
StDev
No.
rats
20.37
7.638
8
14.42
8.659
4
31.88
6.818
4
NC
F
Mean
StDev
No.
rats
19.72
16.926
4
12.12
23.703
4
31.84
8.975
4
*significantly
decreased
compared
to
naive
control
(NC)
group
(p
0.05)
D.
Food
Consumption
Average
daily
food
consumption
is
summarized
in
Table
5.
Food
consumption
was
significantly
increased
in
the
male
TS
group
compared
to
the
control.
[
Sporodex
L
/
2001
0304
/
PLG
]
~
PROTECTED
~
Intraperitoneal
Infectivity
Study
/
7
[
Pseudozyma
flocculosa
/
2000
0680
/
STF]
DACO
M4.
3.
3
TABLE
4.
Average
Daily
Food
Consumption
Treatment
Group
Sex
Parameter
Average
Daily
Consumption
(g/
animal)
TS
M
Mean
StDev
No.
rats
26.83*
2.361
8
KTS
M
Mean
StDev
No.
rats
24.97
1.411
8
NC
M
Mean
StDev
No.
rats
23.74
0.809
4
*
significantly
increased
compared
to
naive
control
(NC)
group
(Dunnett's
test,
p
0.05)
TABLE
4
contd.
Treatment
Group
Sex
Average
Daily
Consumption
(g)
TS
F
Mean
StDev
No.
rats
20.22
1.455
8
KTS
F
Mean
StDev
No.
rats
18.77
1.081
8
NC
F
Mean
StDev
No.
rats
18.45
0.745
4
E.
Necropsy
Results
Incidences
of
gross
necropsy
observations
are
summarized
in
Table
5.
No
gross
lesions
were
found
in
any
of
the
NC
animals.
Among
the
animals
which
were
sacrificed
on
day
7,
white
nodules
were
observed
on
the
stomach
of
one
TS
male
rat,
on
the
caecum
of
one
KTS
male
rat,
on
the
liver
of
one
KTS
male
rat,
and
on
the
small
intestine
of
one
TS
female
rat.
White
nodules
were
also
observed
on
the
liver
and
mesenteric
lymph
nodes
of
one
KTS
male
rat
sacrificed
on
day
14.
TABLE
5.
Gross
Necropsy
Observations
TS
KTS
NC
Observation
M
F
M
F
M
F
Number
of
animals
12
12
12
12
4
4
[
Sporodex
L
/
2001
0304
/
PLG
]
~
PROTECTED
~
Intraperitoneal
Infectivity
Study
/
8
[
Pseudozyma
flocculosa
/
2000
0680
/
STF]
DACO
M4.
3.
3
Stomach
single
white
nodule
1
a
0
0
0
0
0
Caecum
single
white
nodule
0
0
1
a
0
0
0
Liver
single
white
nodule
0
0
2
a,
b
0
0
0
Mesenteric
Lymph
Node
multiple
white
nodules
0
01
b
0
0
0
Small
Intestine
single
white
nodule
0
1
a
0
0
0
0
No
observed
signs
11
11
9
12
4
4
a
observed
on
day
7
b
observed
on
day
14
F.
Organ
Weights
Relative
organ
weight
data
is
summarized
in
Tables
6
and
7.
Statistical
analysis
of
relative
organ
weights
was
conducted
for
day
14
data
only.
Relative
stomach
and
small
intestine
weights
of
TS
dosed
female,
TSdosed
male
and
KTS
dosed
male
rats
were
significantly
decreased
compared
to
naive
controls.
Relative
weights
of
the
lung
and
associated
lymph
nodes
of
KTS
dosed
female
rats
was
significantly
increased
compared
to
controls.
The
mean
relative
spleen
weight
of
both
KTS
and
TS
dosed
female
rats
was
significantly
increased
compared
to
the
NC
group.
Table
6.
Effect
of
Intraperitoneal
Administration
of
S.
flocculosa
on
Relative
Organ/
Tissue
Weights
of
Male
Rats
Relative
Organ
Weight
a
Day
Group
Brain
Heart
Kidneys
Liver
Lung
&
Lymph
Nodes
Mesenteric
Lymph
Nodes
Spleen
Stomach
and
Small
Intestine
0
TS
Mean
b
StDev
0.741
0.0337
0.430
0.0364
0.977
0.0249
5.270
0.5077
0.858
0.0283
0.895
0.3721
0.249
0.0143
5.160
2.7196
KTS
Mean
StDev
0.785
0.0289
0.413
0.0243
1.009
0.0674
5.170
0.1280
0.986
0.3233
0.867
0.2985
0.259
0.0507
4.591
1.2544
7
TS
Mean
StDev
0.684
0.0396
0.460
0.0212
1.001
0.0325
4.475
0.1183
0.605
0.0505
0.519
0.0618
0.259
0.0458
6.821
1.2594
KTS
Mean
StDev
0.676
0.0396
0.406
0.0187
0.931
0.0395
4.876
0.3523
0.611
0.0909
0.667
0.1362
0.271
0.0206
5.795
1.1140
[
Sporodex
L
/
2001
0304
/
PLG
]
~
PROTECTED
~
Intraperitoneal
Infectivity
Study
/
9
[
Pseudozyma
flocculosa
/
2000
0680
/
STF]
DACO
M4.
3.
3
Relative
Organ
Weight
a
Day
Group
Brain
Heart
Kidneys
Liver
Lung
&
Lymph
Nodes
Mesenteric
Lymph
Nodes
Spleen
Stomach
and
Small
Intestine
14
TS
Mean
StDev
0.661
0.0591
0.415
0.0289
0.957
0.0860
3.808
0.4701
0.662
0.0913
0.406
0.1480
0.321
0.2596
2.767*
0.7141
KTS
Mean
StDev
0.639
0.0335
0.456
0.0253
0.868
0.0386
4.128
0.4142
0.622
0.0501
0.589
0.2014
0.220
0.0258
3.291*
0.4613
NC
Mean
StDev
0.630
0.0177
0.435
0.0496
0.956
0.0546
4.268
0.0460
0.543
0.0511
0.507
0.1138
0.218
0.0223
4.676
0.5195
a
Relative
Organ
Weight
=
[Absolute
Organ
Weight
(g)
/
Body
Weight
(g)]
x
100
b
N
=4
*
Statistically
significant
from
NC
(p
0.05)
Table
7.
Effect
of
Intraperitoneal
Administration
of
S.
flocculosa
on
Relative
Organ/
Tissue
Weights
of
Female
Rats.
Relative
Organ
Weight
a
Day
Group
Brain
Heart
Kidneys
Liver
Lung
&
Lymph
Nodes
Mesenteric
Lymph
Nodes
Spleen
Stomach
and
Small
Intestine
0
TS
Mean
b
StDev
0.903
0.0553
0.407
0.0627
1.026
0.0758
4.473
0.5318
0.911
0.3390
0.865
0.5278
0.268
0.0144
4.757
1.2177
KTS
Mean
StDev
0.968
0.0547
0.429
0.0336
0.979
0.0660
4.522
0.1894
1.002
0.2213
1.017
0.3033
0.260
0.0302
5.611
2.4295
7
TS
Mean
StDev
0.917
0.0378
0.515
0.0568
0.929
0.0616
4.392
0.2831
0.647
0.0540
0.595
0.0692
0.254
0.0310
5.577
0.1664
KTS
Mean
StDev
0.875
0.0184
0.444
0.0507
0.859
0.0699
4.392
0.2436
0.617
0.0309
0.523
0.1625
0.250
0.0762
5.275
0.3905
14
TS
Mean
StDev
0.830
0.0433
0.485
0.0768
0.899
0.0804
3.918
0.2160
0.682
0.0297
0.512
0.1119
0.261*
0.0241
2.742*
0.8329
KTS
Mean
StDev
0.806
0.0292
0.497
0.0202
0.892
0.0343
4.691
0.3159
0.827*
0.1596
0.580
0.1438
0.242*
0.0396
5.242
0.7454
NC
Mean
StDev
0.854
0.0665
0.465
0.0503
0.909
0.0512
4.637
0.6254
0.536
0.1133
0.536
0.0486
0.190
0.0164
5.025
0.8028
a
Relative
Organ
Weight
=
[Absolute
Organ
Weight
(g)
/
Body
Weight
(g)]
x
100
b
N
=3
*
Statistically
significant
from
NC
(p
0.05)
G.
Test
Substance
Enumeration
Tables
8
and
9
summarize
the
results
of
microbial
enumeration
from
various
organs,
blood
and
peritoneal
[
Sporodex
L
/
2001
0304
/
PLG
]
~
PROTECTED
~
Intraperitoneal
Infectivity
Study
/
10
[
Pseudozyma
flocculosa
/
2000
0680
/
STF]
DACO
M4.
3.
3
fluid.
Sporothrix
flocculosa
was
recovered
from
the
caecum,
kidneys,
liver,
lungs
and
associated
lymph
nodes,
mesenteric
lymph
nodes,
spleen
and
stomach
and
small
intestines
of
both
male
and
female
TS
dosed
rats.
Sporothrix
flocculosa
was
also
recovered
from
the
peritoneal
fluid
of
TS
dosed
male
rats
and
from
the
blood
of
TS
dosed
female
rats.
The
test
substance
was
only
recovered
from
animals
sacrificed
on
day
0
(post
dosing),
indicating
clearance
within
7
days.
No
test
substance
was
recovered
from
the
KTS
dosed
or
NC
groups
of
animals.
[
Sporodex
L
/
2001
0304
/
PLG
]
~
PROTECTED
~
Intraperitoneal
Infectivity
Study
/
11
[
Pseudozyma
flocculosa
/
2000
0680
/
STF]
DACO
M4.
3.
3
TABLE
8.
Recovery
of
Sporothrix
flocculosa
Following
Intraperitoneal
Administration
from
Selected
Tissues/
Fluids
of
Male
Rats
Log
[(
cfu/
g
of
tissue)
+
1]
or
Log
[(
cfu/
mL
of
blood
or
peritoneal
fluid)
+
1]
Group
Day
Blood
Brain
Caecum
Heart
Kidney
s
Live
r
Lungs
&
Lymph
Nodes
Mesenteric
Lymph
Nodes
Peritoneal
Fluid
Spleen
Stomach
&
Small
Intestine
TS
0
Mean
SD
GeoMn
b
N
BDL
a
BDL
BDL
4
BDL
BDL
BDL
4
2.791
1.872
6.16
x
10
2
4
BDL
BDL
BDL
4
2.134
1.502
1.35
x
10
2
4
4.031
0.729
1.07
x
10
4
4
1.721
2.039
5.16
x
10
1
4
4.844
1.188
6.99
x
10
4
4
2.565
2.962
3.66
x
10
2
4
3.134
2.192
1.36
x
10
3
4
6.049
0.358
1.15
x
10
6
4
KTS
0
Mean
SD
GeoMn
N
BDL
BDL
BDL
4
BDL
BDL
BDL
4
BDL
BDL
BDL
4
BDL
BDL
BDL
4
BDL
BDL
BDL
4
BDL
BDL
BDL
4
BDL
BDL
BDL
4
BDL
BDL
BDL
4
BDL
BDL
BDL
4
BDL
BDL
BDL
4
BDL
BDL
BDL
4
TS
7
Mean
SD
GeoMn
N
BDL
BDL
BDL
4
BDL
BDL
BDL
4
BDL
BDL
BDL
4
BDL
BDL
BDL
4
BDL
BDL
BDL
4
BDL
BDL
BDL
4
BDL
BDL
BDL
4
BDL
BDL
BDL
4
BDL
BDL
BDL
4
BDL
BDL
BDL
4
BDL
BDL
BDL
4
KTS
7
Mean
SD
GeoMn
N
BDL
BDL
BDL
4
BDL
BDL
BDL
4
BDL
BDL
BDL
4
BDL
BDL
BDL
4
BDL
BDL
BDL
4
BDL
BDL
BDL
4
BDL
BDL
BDL
4
BDL
BDL
BDL
4
BDL
BDL
BDL
4
BDL
BDL
BDL
4
BDL
BDL
BDL
4
TS
14
Mean
SD
GeoMn
N
BDL
BDL
BDL
4
BDL
BDL
BDL
4
BDL
BDL
BDL
4
BDL
BDL
BDL
4
BDL
BDL
BDL
4
BDL
BDL
BDL
4
BDL
BDL
BDL
4
BDL
BDL
BDL
4
BDL
BDL
BDL
4
BDL
BDL
BDL
4
BDL
BDL
BDL
4
KTS
14
Mean
SD
GeoMn
N
BDL
BDL
BDL
4
BDL
BDL
BDL
4
BDL
BDL
BDL
4
BDL
BDL
BDL
4
BDL
BDL
BDL
4
BDL
BDL
BDL
4
BDL
BDL
BDL
4
BDL
BDL
BDL
4
BDL
BDL
BDL
4
BDL
BDL
BDL
4
BDL
BDL
BDL
4
NC
14
Mean
SD
GeoMn
N
BDL
BDL
BDL
4
BDL
BDL
BDL
4
BDL
BDL
BDL
4
BDL
BDL
BDL
4
BDL
BDL
BDL
4
BDL
BDL
BDL
4
BDL
BDL
BDL
4
BDL
BDL
BDL
4
BDL
BDL
BDL
4
BDL
BDL
BDL
4
BDL
BDL
BDL
4
a
BDL
below
detection
limit
b
GeoMn
geometric
mean
of
CFU/
tissue
or
mL
of
blood
or
peritoneal
fluid
[
Sporodex
L
/
2001
0304
/
PLG
]
~
PROTECTED
~
Intraperitoneal
Infectivity
Study
/
12
[
Pseudozyma
flocculosa
/
2000
0680
/
STF]
DACO
M4.
3.
3
TABLE
9.
Recovery
of
Sporothrix
flocculosa
Following
Intraperitoneal
Administration
from
Selected
Tissues/
Fluids
of
Female
Rats
Log
[(
CFU/
g
of
tissue)
+
1]
or
Log
[(
CFU/
mL
of
blood
or
peritoneal
fluid)
+
1]
Group
Day
Blood
Brain
Caecum
Heart
Kidney
s
Live
r
Lungs
&
Lymph
Nodes
Mesenteric
Lymph
Nodes
Peritoneal
Fluid
Spleen
Stomach
&
Small
Intestine
TS
0
Mean
SD
GeoMn
b
N
0.644
1.288
4.41
x
10
0
4
BDL
BDL
BDL
4
5.421
1.200
2.64x
10
5
4
BDL
BDL
BDL
4
0.734
1.467
5.42
x
10
0
4
3.392
2.461
2.47
x
10
3
4
1.322
1.527
2.00
x
10
1
4
3.698
2.748
4.99
x
10
3
4
BDL
BDL
BDL
4
1.977
2.283
9.38
x
10
1
4
4.477
1.257
3.00
x
10
4
4
KTS
0
Mean
SD
GeoMn
N
BDL
BDL
BDL
4
BDL
BDL
BDL
4
BDL
BDL
BDL
4
BDL
BDL
BDL
4
BDL
BDL
BDL
4
BDL
BDL
BDL
4
BDL
BDL
BDL
4
BDL
BDL
BDL
4
BDL
BDL
BDL
4
BDL
BDL
BDL
4
BDL
BDL
BDL
4
TS
7
Mean
SD
GeoMn
N
BDL
BDL
BDL
4
BDL
BDL
BDL
4
BDL
BDL
BDL
4
BDL
BDL
BDL
4
BDL
BDL
BDL
4
BDL
BDL
BDL
4
BDL
BDL
BDL
4
BDL
BDL
BDL
4
BDL
BDL
BDL
4
BDL
BDL
BDL
4
BDL
BDL
BDL
4
KTS
7
Mean
SD
GeoMn
N
BDL
BDL
BDL
4
BDL
BDL
BDL
4
BDL
BDL
BDL
4
BDL
BDL
BDL
4
BDL
BDL
BDL
4
BDL
BDL
BDL
4
BDL
BDL
BDL
4
BDL
BDL
BDL
4
BDL
BDL
BDL
4
BDL
BDL
BDL
4
BDL
BDL
BDL
4
TS
14
Mean
SD
GeoMn
N
BDL
BDL
BDL
4
BDL
BDL
BDL
4
BDL
BDL
BDL
4
BDL
BDL
BDL
4
BDL
BDL
BDL
4
BDL
BDL
BDL
4
BDL
BDL
BDL
4
BDL
BDL
BDL
4
BDL
BDL
BDL
4
BDL
BDL
BDL
4
BDL
BDL
BDL
4
KTS
14
Mean
SD
GeoMn
N
BDL
BDL
BDL
4
BDL
BDL
BDL
4
BDL
BDL
BDL
4
BDL
BDL
BDL
4
BDL
BDL
BDL
4
BDL
BDL
BDL
4
BDL
BDL
BDL
4
BDL
BDL
BDL
4
BDL
BDL
BDL
4
BDL
BDL
BDL
4
BDL
BDL
BDL
4
NC
14
Mean
SD
GeoMn
N
BDL
BDL
BDL
4
BDL
BDL
BDL
4
BDL
BDL
BDL
4
BDL
BDL
BDL
4
BDL
BDL
BDL
4
BDL
BDL
BDL
4
BDL
BDL
BDL
4
BDL
BDL
BDL
4
BDL
BDL
BDL
4
BDL
BDL
BDL
4
BDL
BDL
BDL
4
a
BDL
below
detection
limit
b
GeoMn
geometric
mean
of
CFU/
tissue
or
mL
of
blood
or
peritoneal
fluid
H.
Reviewer's
Conclusions
This
intraperitoneal
infectivity
study
is
classified
as
acceptable.
Sporothrix
flocculosa
was
considered
to
be
non
pathogenic
but
slightly
toxic,
at
the
dose
administered
via
the
intraperitoneal
route,
due
to
decreased
body
weight
gain
coupled
with
increased
food
consumption
in
TS
dosed
male
rats.
The
nodules
observed
at
necropsy
in
both
TS
and
KTS
dosed
rats
and
the
higher
relative
spleen
weights
were
the
result
of
the
body's
normal
immunological
response
to
a
foreign
substance.
Changes
in
the
relative
weight
of
stomach
and
small
intestines
of
TS
and
KTS
dosed
animals
were
likely
not
biologically
significant
as
evidenced
by
the
variability
in
the
data.
The
detection
of
S.
flocculosa
in
the
peritoneal
fluid
lavage
of
TS
dosed
male
[
Sporodex
L
/
2001
0304
/
PLG
]
~
PROTECTED
~
Intraperitoneal
Infectivity
Study
/
13
[
Pseudozyma
flocculosa
/
2000
0680
/
STF]
DACO
M4.
3.
3
rats
was
consistent
with
the
method
of
administration.
Clearance
of
S.
flocculosa
from
all
other
tissues
and
fluidsoccurred
by
day7.
I.
Deficiencies
The
number
of
air
changes
per
hour
was
not
reported.
However,
given
the
data
presented,
this
omission
is
considered
to
have
no
impact
on
the
interpretation
of
the
study
results.
Also,
the
relative
humidity
recorded
in
the
animal
room
was
outside
the
preferred
range,
30
70%.
This
occurrence
is
considered
to
have
no
adverse
effects
on
the
outcome
of
this
study.
| epa | 2024-06-07T20:31:43.400691 | regulations | {
"license": "Public Domain",
"url": "https://downloads.regulations.gov/EPA-HQ-OPP-2002-0233-0018/content.txt"
} |
EPA-HQ-OPP-2002-0235-0001 | Rule | "2002-09-25T04:00:00" | Clopyralid; Pesticide Tolerance | 60152
Federal
Register
/
Vol.
67,
No.
186
/
Wednesday,
September
25,
2002
/
Rules
and
Regulations
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
FFDCA
section
408(
n)(
4).
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.
XIII.
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:
September
11,
2002.
James
Jones,
Acting
Director,
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
180.1222
is
added
to
subpart
D
to
read
as
follows:
§
180.1222
Sucrose
octanoate
esters;
exemption
from
the
requirement
of
a
tolerance.
An
exemption
from
the
requirement
of
a
tolerance
is
established
for
residues
of
sucrose
octanoate
esters
[(
a
Dglucopyranosyl
b
D
fructofuranosyloctanoate
mono,
di,
and
triesters
of
sucrose
octanoate]
in
or
on
all
food
commodities
when
used
in
accordance
with
good
agricultural
practices.
[FR
Doc.
02–
24224
Filed
9–
24–
02;
8:
45
am]
BILLING
CODE
6560–
50–
S
ENVIRONMENTAL
PROTECTION
AGENCY
40
CFR
Part
180
[OPP–
2002–
0235;
FRL–
7198–
4]
Clopyralid;
Pesticide
Tolerance
AGENCY:
Environmental
Protection
Agency
(EPA).
ACTION:
Final
rule.
SUMMARY:
This
regulation
establishes
tolerances
for
residues
of
clopyralid
in
or
on
certain
raw
agricultural
commodities.
Interregional
Research
Project
Number
4
(IR
4)
and
Dow
Agro
Sciences
LLC
requested
these
tolerances
under
the
Federal
Food,
Drug,
and
Cosmetic
Act,
as
amended
by
the
Food
Quality
Protection
Act
of
1996.
DATES:
This
regulation
is
effective
September
25,
2002.
Objections
and
requests
for
hearings,
identified
by
docket
control
number
OPP–
2002–
0235,
must
be
received
on
or
before
November
25,
2002.
ADDRESSES:
Written
objections
and
hearing
requests
may
be
submitted
by
mail,
in
person,
or
by
courier.
Please
follow
the
detailed
instructions
for
each
method
as
provided
in
Unit
VI.
of
the
SUPPLEMENTARY
INFORMATION.
To
ensure
proper
receipt
by
EPA,
your
objections
and
hearing
requests
must
identify
docket
control
number
OPP–
2002–
0235
in
the
subject
line
on
the
first
page
of
your
response.
FOR
FURTHER
INFORMATION
CONTACT:
By
mail:
Joanne
I.
Miller,
Registration
Division
(7505C),
Office
of
Pesticide
Programs,
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460;
telephone
number:
703
305–
6224;
and
e
mail
address:
miller.
joanne@
epamail.
epa.
gov.
SUPPLEMENTARY
INFORMATION:
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:
Categories
NAICS
codes
Examples
of
potentially
affected
entities
Industry
111
112
311
32532
Crop
production
Animal
production
Food
manufacturing
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
the
table
could
also
be
affected.
The
North
American
Industrial
Classification
System
(NAICS)
codes
have
been
provided
to
assist
you
and
others
in
determining
whether
or
not
this
action
might
apply
to
certain
entities.
If
you
have
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
Additional
Information,
Including
Copies
of
this
Document
and
Other
Related
Documents?
1.
Electronically.
You
may
obtain
electronic
copies
of
this
document,
and
certain
other
related
documents
that
might
be
available
electronically,
from
the
EPA
Internet
Home
Page
at
http://
www.
epa.
gov/.
To
access
this
document,
on
the
Home
Page
select
``
Laws
and
Regulations,
''
``
Regulations
and
VerDate
Sep<
04>
2002
14:
45
Sep
24,
2002
Jkt
197001
PO
00000
Frm
00046
Fmt
4700
Sfmt
4700
E:\
FR\
FM\
25SER1.
SGM
25SER1
60153
Federal
Register
/
Vol.
67,
No.
186
/
Wednesday,
September
25,
2002
/
Rules
and
Regulations
Proposed
Rules,
''
and
then
look
up
the
entry
for
this
document
under
the
``
Federal
Register—
Environmental
Documents.
''
You
can
also
go
directly
to
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.
2.
In
person.
The
Agency
has
established
an
official
record
for
this
action
under
docket
control
number
OPP–
2002–
0235.
The
official
record
consists
of
the
documents
specifically
referenced
in
this
action,
and
other
information
related
to
this
action,
including
any
information
claimed
as
Confidential
Business
Information
(CBI).
This
official
record
includes
the
documents
that
are
physically
located
in
the
docket,
as
well
as
the
documents
that
are
referenced
in
those
documents.
The
public
version
of
the
official
record
does
not
include
any
information
claimed
as
CBI.
The
public
version
of
the
official
record,
which
includes
printed,
paper
versions
of
any
electronic
comments
submitted
during
an
applicable
comment
period
is
ailable
for
inspection
in
the
Public
Information
and
Records
Integrity
Branch
(PIRIB),
Rm.
119,
Crystal
Mall
#2,
1921
Jefferson
Davis
Hwy.,
Arlington,
VA,
from
8:
30
a.
m.
to
4
p.
m.,
Monday
through
Friday,
excluding
legal
holidays.
The
PIRIB
telephone
number
is
(703)
305–
5805.
II.
Background
and
Statutory
Findings
In
the
Federal
Register
of
August
14,
2002
(67
FR
52990)
(FRL–
7191–
7),
EPA
issued
a
notice
pursuant
to
section
408
of
the
Federal
Food,
Drug,
and
Cosmetic
Act
(FFDCA),
21
U.
S.
C.
346a,
as
amended
by
the
Food
Quality
Protection
Act
of
1996
(FQPA)
(Public
Law
104–
170),
announcing
the
filing
of
pesticide
petitions
(PP
1E6227,
1E6241,
1E6283,
1E6291,
1E6320,
1E6329,
1E6333,
1E6334,
1E6335,
1E6399,
and
1E6340
)
by
the
Interregional
Research
Project
Number
4
(IR
4),
P.
O.
Box
231,
Rutgers
University,
New
Brunswick,
NJ
08903
and
PP
4F4379
from
Dow
Agro
Sciences
LLC,
Indianapolis,
IN
46268.
This
notice
included
a
summary
of
the
petition
prepared
by
Dow
Agro
Sciences
LLC,
the
registrant.
There
were
no
comments
received
in
response
to
the
notice
of
filing.
The
petitions
requested
that
40
CFR
180.431
be
amended
by
establishing
tolerances
for
residues
of
the
herbicide
clopyralid,
3,6
dichloro
2
pyridinecarboxylic
acid,
in
or
on
the
following
commodities:
Flax
seed
at
3.0
part
per
million
(ppm);
strawberry
at
1.0
ppm;
hop,
dried
cones
at
5.0
ppm;
rapeseed
seed,
rapeseed
forage,
canola
seed,
mustard
seed,
and
crambe
seed
at
3
ppm,
and
canola
meat
at
6.0
ppm;
spinach
at
5.0
ppm;
stone
fruit
group
at
0.5
ppm;
garden
beet
tops
at
3.0
ppm
and
garden
beet
roots
at
4.0
ppm;
mustard
greens
at
5.0
ppm;
turnip
roots
at
1.0
ppm
and
turnip
greens
at
4.0
ppm;
cranberry
at
4
ppm;
sweet
corn,
kernel
plus
cob
with
husks
removed
at
1.0
ppm,
sweet
corn
forage
at
7.0
ppm,
sweet
corn
stover
at
10.0
ppm,
pop
corn
grain
at
1.0
ppm,
pop
corn
stover
at
10.0
ppm,
liver
of
cattle,
goat,
horse,
and
sheep
at
3.0
ppm,
meat
byproducts,
except
liver,
of
cattle,
goat,
horse
and
sheep
at
36.0
ppm,
and
milk
at
0.2
ppm;
and
the
brassica,
head
and
stem,
subgroup
at
2.0
ppm.
EPA
is
editorially
correcting
the
tolerance
expressions
to
read
canola
meal
and
turnip,
tops.
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)
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)
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
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),
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),
for
a
tolerance
for
residues
of
clopyralid
on
strawberry
at
1.0
ppm;
hop,
dried
cones,
at
5.0
ppm;
rapeseed
seed,
rapeseed
forage,
mustard
seed,
and
crambe
seed
at
3
ppm,
canola
meal
and
flax
meal
at
6.0
ppm;
spinach
at
5.0
ppm;
stone
fruit
group
at
0.5
ppm;
prunes
at
1.5
ppm,
garden
beet
tops
at
3.0
ppm
and
garden
beet
roots
at
4.0
ppm;
mustard
greens
at
5.0
ppm;
turnip
roots
at
1.0
ppm
and
turnip
tops
at
4.0
ppm;
cranberry
at
4.0
ppm;
sweet
corn,
kernel
plus
cob
with
husks
removed
at
1.0
ppm,
sweet
corn
forage
at
7.0
ppm,
sweet
corn
stover
at
10.0
ppm,
pop
corn
grain
at
1.0
ppm,
pop
corn
stover
at
10.0
ppm,
liver
of
cattle,
goat,
horse,
and
sheep
at
3.0
ppm,
meat
byproducts,
except
liver,
of
cattle,
goat,
horse
and
sheep
at
36.0
ppm,
and
milk
at
0.2
ppm;
and
the
Brassica,
head
and
stem,
subgroup
at
2.0
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
clopyralid
are
discussed
in
the
following
Table
1
and
Table
2
as
well
as
the
no
observed
adverse
effect
level
(NOAEL)
and
the
lowest
observed
adverse
effect
level
(LOAEL)
from
the
toxicity
studies
reviewed.
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TABLE
1.—
SUBCHRONIC,
CHRONIC,
AND
OTHER
TOXICITY
OF
CLOPYRALID
Guideline
No.
Study
Type
Results
870.3100
90–
Day
oral
toxicity
in
mice
NOAEL
=
2,000
mg/
kg/
day
in
both
sexes.
LOAEL
=
5,000
mg/
kg/
day
in
both
sexes
based
on
decreased
body
weight
in
both
sexes.
870.3200
21/
28–
Day
dermal
toxicity
in
rabbits
NOAEL
=
1,000
mg/
kg/
day
for
both
sexes.
870.3700
Prenatal
developmental
toxicity
in
rats
Maternal
NOAEL
=
75
mg/
kg/
day
LOAEL
=
250
mg/
kg/
day
based
on
mortality,
reduced
body
weight
gains
and
reduced
food
consumption.
Developmental
NOAEL
=
250
mg/
kg/
day
highest
dose
tested
(HDT).
870.3700
Prenatal
developmental
toxicity
in
rabbits
Maternal
NOAEL
=
110
mg/
kg/
day.
LOAEL
=
250
mg
/kg/
day
based
on
mortality,
clinical
signs,
decreased
body
weight
gains,
and
lesions
of
the
gastric
mucosa.
Developmental
NOAEL
=
110
mg/
kg/
day.
LOAEL
=
250
mg/
kg/
day
based
on
decreased
fetal
body
weight
and
hydrocephalus.
870.3800
Reproduction
and
fertility
effects
in
rats
Systemic
NOAEL
=
500
mg/
kg/
day
for
males
and
females
LOAEL
=
1,500
mg/
kg/
day
for
males
and
females
based
on
decreased
body
weights,
decreased
weight
gain,
and
decreased
food
consumption
in
both
sexes
and
slight
focal
hyperkeratotic
changes
in
gastric
squamous
mucosa
in
males.
Reproductive/
Offspring
NOAEL
=
500
mg/
kg/
day
LOAEL
=
1,500
mg/
kg/
day
for
males
and
females
based
on
reduced
pup
weights
in
males
and
increased
relative
liver
weight
in
pups
of
both
sexes.
870.4100
Chronic
toxicity
dogs
NOAEL
=
100
mg/
kg/
day
in
males
and
females.
LOAEL
=
320
mg/
kg/
day
based
upon
reduction
in
hematological
parameters
in
both
sexes,
increased
absolute
liver
weight
in
males,
and
vacuolated
adrenal
cortical
cells
in
females.
870.4200
Carcinogenicity
mice
NOAEL
=
500
mg/
kg/
day
and
2,000
mg/
kg/
day
in
females.
LOAEL
=
2,000
mg/
kg/
day
in
males
based
on
decreased
body
weight,
body
weight
gains,
and
food
efficiency.
No
evidence
of
carcinogenicity.
870.4300
Combined
Chronic
Toxicity/
Carcinogenicity
in
rats
NOAEL
=
15
mg/
kg/
day.
LOAEL
=
150
mg/
kg/
day
based
on
epithelial
hyperplasia
and
thickening
of
the
limiting
ridge
of
the
stomach
in
both
sexes.
No
evidence
of
carcinogenicity.
870.5300
In
vitro
and
in
vivo
host
mediated
assay
in
bacteria
No
evidence
of
induced
mutant
colonies
over
background
in
Salmonella
strains
TA
1,530
bacteria
and
G
46
and
Saccharomyces
strain
D
3
870.5385
Bone
marrow
chromosome
aberrations
assay
There
was
no
significant
increase
in
the
frequency
of
chromosome
aberrations
in
bone
marrow
at
any
dose
tested.
870.5550
In
vitro
unscheduled
DNA
synthesis
assay
There
was
no
evidence
of
unscheduled
DNA
synthesis
in
initial
or
supplementary
assays
870.5450
Dominant
lethal
assay
in
rats.
No
evidence
of
treatment
related
resorptions
up
to
400
mg/
kg/
day
for
5
days.
870.7485
Metabolism
in
rats
Rapidly
absorbed
and
excreted
mainly
in
the
urine.
Parent
compound
only
is
detected
in
the
excreta.
B.
Toxicological
Endpoints
The
dose
at
which
the
NOAEL
from
the
toxicology
study
identified
as
appropriate
for
use
in
risk
assessment
is
used
to
estimate
the
toxicological
level
of
concern
(LOC).
However,
the
lowest
dose
at
which
the
LOAEL
is
sometimes
used
for
risk
assessment
if
no
NOAEL
was
achieved
in
the
toxicology
study
selected.
An
uncertainty
factor
(UF)
is
applied
to
reflect
uncertainties
inherent
in
the
extrapolation
from
laboratory
animal
data
to
humans
and
in
the
variations
in
sensitivity
among
members
of
the
human
population
as
well
as
other
unknowns.
An
UF
of
100
is
routinely
used,
10X
to
account
for
interspecies
differences
and
10X
for
intra
species
differences.
For
dietary
risk
assessment
(other
than
cancer)
the
Agency
uses
the
UF
to
calculate
an
acute
or
chronic
reference
dose
(acute
RfD
or
chronic
RfD)
where
the
RfD
is
equal
to
the
NOAEL
divided
by
the
appropriate
UF
(RfD
=
NOAEL/
UF).
Where
an
additional
safety
factor
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
Safety
Factor.
For
non
dietary
risk
assessments
(other
than
cancer)
the
UF
is
used
to
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Regulations
determine
the
LOC.
For
example,
when
100
is
the
appropriate
UF
(10X
to
account
for
interspecies
differences
and
10X
for
intraspecies
differences)
the
LOC
is
100.
To
estimate
risk,
a
ratio
of
the
NOAEL
to
exposures
(margin
of
exposure
(MOE)
=
NOAEL/
exposure)
is
calculated
and
compared
to
the
LOC.
The
linear
default
risk
methodology
(Q*)
is
the
primary
method
currently
used
by
the
Agency
to
quantify
carcinogenic
risk.
The
Q*
approach
assumes
that
any
amount
of
exposure
will
lead
to
some
degree
of
cancer
risk.
A
Q*
is
calculated
and
used
to
estimate
risk
which
represents
a
probability
of
occurrence
of
additional
cancer
cases
(e.
g.,
risk
is
expressed
as
1
x
10
6
or
one
in
a
million).
Under
certain
specific
circumstances,
MOE
calculations
will
be
used
for
the
carcinogenic
risk
assessment.
In
this
non
linear
approach,
a
``
point
of
departure''
is
identified
below
which
carcinogenic
effects
are
not
expected.
The
point
of
departure
is
typically
a
NOAEL
based
on
an
endpoint
related
to
cancer
effects
though
it
may
be
a
different
value
derived
from
the
dose
response
curve.
To
estimate
risk,
a
ratio
of
the
point
of
departure
to
exposure
(MOEcancer
=
point
of
departure/
exposures)
is
calculated.
A
summary
of
the
toxicological
endpoints
for
clopyralid
used
for
human
risk
assessment
is
shown
in
the
following
Table
2:
TABLE
2.—
SUMMARY
OF
TOXICOLOGICAL
DOSE
AND
ENDPOINTS
FOR
CLOPYRALID
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)
NOAEL
=
75
mg/
kg/
day
UF
=
100
Acute
RfD
=
0.75
mg/
kg/
day
FQPA
SF
=
1X
aPAD
=
acute
RfD/
FQPA
SF
=
0.75
mg/
kg/
day
Developmental
Toxicity
Study
rat
Maternal
LOAEL
=
250
mg
ai/
kg/
day
based
on
decreased
weight
gain
during
gestation
days
6–
9
Chronic
Dietary
(All
populations)
NOAEL
=
15
mg/
kg/
day
UF
=
100
Chronic
RfD
=
0.15
mg/
kg/
day
FQPA
SF
=
1X
cPAD
=
chronic
RfD/
FQPA
SF
=
0.15
mg/
kg/
day
2–
Year
Chronic
Toxicity/
Carcinogenicity
Study
rat
LOAEL
=
150
mg
ai/
kg/
day
based
on
increased
epithelial
hyperplasia
and
thickening
of
the
limiting
ridge
of
the
stomach
in
both
sexes
Short
Term
Incidental
Oral
NOAEL
=
75
mg/
kg/
day
LOC
for
MOE
=
100
Developmental
Toxicity
Study
rat
Maternal
LOAEL
=
250
mg
ai/
kg/
day
based
on
decreased
weight
gain
during
gestation
days
6–
9
Intermediate
Term
Incidental
Oral
NOAEL
=
15
mg/
kg/
day
LOC
for
MOE
=
100
2–
Year
Chronic
Toxicity/
Carcinogenicity
Study
rat
LOAEL
=
150
mg
ai/
kg/
day
based
on
increased
epithelial
hyperplasia
and
thickening
of
the
limiting
ridge
of
the
stomach
in
both
sexes
Short–
Term
(1–
7
days)
and
Intermediate
Term
(1
week
several
months)
Dermal
None
No
systemic
toxicity
was
seen
at
the
limit
dose
(1,000
mg/
kg/
day)
in
the
21–
day
dermal
toxicity
study
in
rabbits.
This
risk
assessment
is
not
required
Not
Applicable
(N/
A)
Short–
Term
(1–
7
days)
Inhalation
NOAEL
=
75
mg/
kg/
day
inhalation
absorption
rate
=
100%)
LOC
for
MOE
=
100
Developmental
Toxicity
Study
rat
Maternal
LOAEL
=
250
mg
ai/
kg/
day
based
on
decreased
body
weight
gain
Cancer
(Oral,
dermal,
inhalation)
Not
likely
N/
A
Acceptable
oral
rat
and
mouse
carcinogenicity
studies;
no
evidence
of
carcinogenic
or
mutagenic
potential.
*
The
reference
to
the
FQPA
Safety
Factor
refers
to
any
additional
safety
factor
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
180.431)
for
the
residues
of
clopyralid,
in
or
on
a
variety
of
raw
agricultural
commodities.
Established,
proposed
and
increased
tolerances
for
clopyralid
are
adequate
for
any
expected
secondary
residues
in
meat,
milk,
poultry
and/
or
eggs.
Risk
assessments
were
conducted
by
EPA
to
assess
dietary
exposures
from
clopyralid
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.
In
conducting
this
acute
dietary
risk
assessment
the
Dietary
Exposure
Evaluation
Model
(DEEM
TM
)
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
acute
exposure
assessments.
Residue
levels
are
at
the
recommended
tolerances
with
the
exception
of
sugar
beets.
The
empirical
processing
factor
of
0.1x
was
used
for
sugar
beet
representing
the
10–
fold
reduction
in
residues
for
refined
sugar.
One
hundred
percent
of
all
of
the
crops
are
treated
with
clopyralid.
ii.
Chronic
exposure.
In
conducting
this
chronic
dietary
risk
assessment
the
Dietary
Exposure
Evaluation
Model
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25,
2002
/
Rules
and
Regulations
(DEEM
TM
)
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.
Residue
levels
are
at
the
recommended
tolerances
with
the
exception
of
sugar
beets.
The
empirical
processing
factor
of
0.1x
was
used
for
sugar
beet
representing
the
10
fold
reduction
in
residues
for
refined
sugar.
One
hundred
percent
of
all
of
the
crops
are
treated
with
clopyralid.
iii.
Cancer.
Acceptable
oral
rat
and
mouse
carcinogenicity
studies
show
no
evidence
of
carcinogenic
or
mutagenic
potential.
Clopyralid
is
classified
as
not
likely
to
be
a
human
carcinogen.
2.
Dietary
exposure
from
drinking
water.
The
Agency
lacks
sufficient
monitoring
exposure
data
to
complete
a
comprehensive
dietary
exposure
analysis
and
risk
assessment
for
clopyralid
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
clopyralid.
The
Agency
uses
the
Generic
Estimated
Environmental
Concentration
(GENEEC)
or
the
Pesticide
Root
Zone
Model/
Exposure
Analysis
Modeling
System
(PRZM/
EXAMS)
to
estimate
pesticide
concentrations
in
surface
water
and
SCI
GROW,
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
high
end
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.
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
clopyralid
they
are
further
discussed
in
the
aggregate
risk
sections
in
Unit
III.
E
of
this
document.
Based
on
the
FIRST
and
SCI
GROW
models
the
estimated
environmental
concentrations
(EECs)
of
clopyralid
for
acute
exposures
are
estimated
to
be
46
parts
per
billion
(ppb)
for
surface
water
and
9.7
ppb
for
ground
water.
The
EECs
for
chronic
exposures
are
estimated
to
be
18
ppb
in
surface
water
and
9.7
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).
Clopyralid
is
currently
registered
for
use
on
the
following
residential
nondietary
sites:
Turf
and
ornamentals
(including
golf
courses).
The
risk
assessment
was
conducted
using
the
following
residential
exposure
assumptions:
the
75
mg/
kg/
day
NOAEL
was
used
in
the
short
term
inhalation,
hand
to
mouth,
and
episodic
granular
ingestion
risk
assessments
of
the
residential
exposure.
The
intermediateterm
assessment
for
children's
hand
tomouth
exposure
was
based
on
the
15
mg/
kg/
day
NOAEL
chosen
for
incidental
oral
exposure.
As
no
dermal
endpoint
was
selected,
a
dermal
risk
assessment
was
not
required
for
residential
exposure.
For
residential
oral
and
inhalation
risk
assessments,
the
target
margin
of
exposure
(MOE)
was
100
which
incorporates
the
removal
of
the
FQPA
Safety
Factor.
MOEs
calculated
for
residential
handler's
inhalation
exposure
and
children's
oral
exposures
were
well
above
the
target
of
100;
and
therefore,
do
not
exceed
the
Agency's
level
of
concern.
4.
Cumulative
exposure
to
substances
with
a
common
mechanism
of
toxicity.
Section
408(
b)(
2)(
D)(
v)
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
clopyralid
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,
clopyralid
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
clopyralid
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.
FFDCA
section
408
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.
No
increased
quantitative
or
qualitative
susceptibility
was
seen
following
pre
and/
or
post
natal
exposures.
In
the
developmental
study
with
rats,
no
developmental
toxicity
was
seen
at
the
HDT
(250
mg/
kg/
day)
even
in
the
presence
of
severe
maternal
toxicity
which
manifested
as
deaths,
reduced
body
weight
gain
and
decreased
food
consumption.
In
the
two
generation
reproduction
study,
offspring
toxicity,
characterized
as
decreased
pup
weight
and
increased
liver
weights,
occurred
only
at
the
HDT
(1,500
mg/
kg/
day)
which
is
higher
than
the
Limit
Dose
(1,000
mg/
kg/
day).
These
changes
occurred
in
the
presence
of
severe
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parental
toxicity
(decreased
body
weight,
body
weight
gain,
food
consumption
and
slight
focal
hyper
keratosis
of
the
gastric
mucosa).
In
the
developmental
rabbit
study,
hydrocephalus
was
seen
in
eight
fetuses
(3/
15
litters)
only
at
the
highest
dose
tested
(250
mg/
kg/
day)
in
the
presence
of
severe
maternal
toxicity
that
manifested
as
death,
decreases
in
mean
body
weight
and
lesions
of
the
gastric
mucosa;
the
developmental
NOAEL
was
110
mg/
kg/
day.
The
available
data
indicate
that
a
developmental
neurotoxicity
study
would
have
to
be
tested
at
dose
levels
higher
than
250
mg/
kg/
day
because
no
developmental
toxicity
was
observed
in
rats
at
250
mg/
kg/
day.
In
addition,
the
offspring
NOAEL
in
the
two
generation
reproduction
study
was
500
mg/
kg/
day
with
a
LOAEL
of
1,500
mg/
kg/
day.
Therefore,
it
is
anticipated
that
in
order
to
elicit
any
fetal
nervous
system
abnormalities
in
a
developmental
neurotoxicity
study,
the
selected
dose
levels
would
have
to
be
higher
than
500
mg/
kg/
day.
Since
the
dose
level
selections
for
the
developmental
neurotoxicity
study
will
be
greater
than
500
mg/
kg/
day,
the
resultant
NOAEL
will
be
either
comparable
to,
or
higher
than
the
doses
currently
used
in
the
risk
assessment.
The
NOAEL
of
75
mg/
kg/
day
selected
for
the
acute
RfD
is
seven
times
lower
than
the
offspring
NOAEL
in
the
reproduction
study.
The
NOAEL
of
15
mg/
kg/
day
selected
for
the
chronic
RfD
and
the
residential
exposure
risk
assessments
is
thirty
three
times
lower
than
the
offspring
NOAEL
in
the
reproduction
study.
Therefore,
a
developmental
neurotoxicity
study
would
not
likely
change
the
regulatory
doses
used
for
overall
risk
assessments.
3.
Conclusion.
EPA
determined
that
an
additional
factor
to
protect
infants
and
children
was
not
appropriate.
Several
factors
influenced
this
decision
not
to
require
a
development
neurotoxicity
(DNT)
study:
i.
Although
hydrocephalus
was
observed
at
the
high
dose
in
the
developmental
rabbit
study,
it
was
seen
in
the
presence
of
severe
maternal
toxicity;
ii.
No
alterations
to
the
fetal
nervous
system
were
seen
in
the
developmental
rat
study
at
the
same
dose
(250
mg/
kg/
day);
iii.
There
was
no
quantitative
or
qualitative
evidence
of
increased
susceptibility
in
the
two
generation
reproduction
study;
iv.
There
is
no
concern
nor
are
there
residual
uncertainties
for
pre
and/
or
post
natal
toxicity;
and
v.
Although
there
are
no
acute
or
subchronic
neurotoxicity
studies,
there
is
no
evidence
of
neurotoxicity
or
neuropathology
in
adult
animals
in
any
of
the
studies.
EPA
decided
that
the
FQPA
safety
factor
should
be
reduced
to
1
rather
than
the
statutory
default
factor
of
10
because
the
existing
toxicology
database,
which
is
complete,
revealed
no
quantitative
or
qualitative
evidence
of
increased
susceptibility
following
in
utero
exposure
to
rats
and
rabbits
and/
or
following
prenatal/
postnatal
exposure
to
rats;
and
dietary
(food
and
drinking
water)
and
residential
exposure
assessments
will
not
underestimate
the
potential
exposures
for
infants,
children,
and/
or
women
of
childbearing
age
from
the
use
of
clopyralid.
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
Office
of
Water
are
used
to
calculate
DWLOCs:
2L/
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
ground
water
are
less
than
the
calculated
DWLOCs,
OPP
concludes
with
reasonable
certainty
that
exposures
to
the
pesticide
in
drinking
water
(when
considered
along
with
other
sources
of
exposure
for
which
OPP
has
reliable
data)
would
not
result
in
unacceptable
levels
of
aggregate
human
health
risk
at
this
time.
Because
OPP
considers
the
aggregate
risk
resulting
from
multiple
exposure
pathways
associated
with
a
pesticide's
uses,
levels
of
comparison
in
drinking
water
may
vary
as
those
uses
change.
If
new
uses
are
added
in
the
future,
OPP
will
reassess
the
potential
impacts
of
residues
of
the
pesticide
in
drinking
water
as
a
part
of
the
aggregate
risk
assessment
process.
1.
Acute
risk.
Using
the
exposure
assumptions
discussed
in
this
unit
for
acute
exposure,
the
acute
dietary
exposure
from
food
to
clopyralid
will
occupy
4%
of
the
aPAD
for
the
U.
S.
population,
2%
of
the
aPAD
for
females
13
years
and
older,
4%
of
the
aPAD
for
all
infants
(
1
year)
and
7%
of
the
aPAD
for
children
1–
6
years.
In
addition,
there
is
potential
for
acute
dietary
exposure
to
clopyralid
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
the
following
Table
3:
TABLE
3.—
AGGREGATE
RISK
ASSESSMENT
FOR
ACUTE
EXPOSURE
TO
CLOPYRALID
Population
Subgroup
aPAD
(mg/
kg)
%
aPAD
(Food)
Surface
Water
EEC
(ppb)
Ground
Water
EEC
(ppb)
Acute
DWLOC
(ppb)
General
U.
S.
Population
0.75
4
46
9.7
25,000
All
Infants
(
1
year)
0.75
4
46
9.7
7,200
Children
1–
6
years
0.75
7
46
9.7
7,000
Females
13–
50
0.75
2
46
9.7
22,000
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2.
Chronic
risk.
Using
the
exposure
assumptions
described
in
this
unit
for
chronic
exposure,
EPA
has
concluded
that
exposure
to
clopyralid
from
food
will
utilize
7%
of
the
cPAD
for
the
U.
S.
population,
7%
of
the
cPAD
for
all
infants
(
1
year)
and
17%
of
the
cPAD
for
children
1–
6
years.
Based
on
the
use
pattern,
chronic
residential
exposure
to
residues
of
clopyralid
is
not
expected.
In
addition,
there
is
potential
for
chronic
dietary
exposure
to
clopyralid
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
the
following
Table
4:
TABLE
4.—
AGGREGATE
RISK
ASSESSMENT
FOR
CHRONIC
(NON
CANCER)
EXPOSURE
TO
CLOPYRALID
Population
Subgroup
cPAD
mg/
kg/
day
%
cPAD
(Food)
Surface
Water
EEC
(ppb)
Ground
Water
EEC
(ppb)
Chronic
DWLOC
(ppb)
U.
S.
Population
0.15
7
18
9.7
4,900
All
Infants
(
1
year)
0.15
7
18
9.7
1,400
Children
1–
6
years
0.15
17
18
9.7
1,200
Females
13–
50
0.15
5
18
9.7
4,300
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).
Clopyralid
is
currently
registered
for
use
that
could
result
in
short
term
residential
exposure
and
the
Agency
has
determined
that
it
is
appropriate
to
aggregate
chronic
food
and
water
and
short
term
exposures
for
clopyralid.
Using
the
exposure
assumptions
described
in
this
unit
for
short
term
exposures,
EPA
has
concluded
that
food
and
residential
exposures
aggregated
result
in
aggregate
MOEs
of
7,000
(U.
S.
population,
food
and
residential),
9,600
(females
13–
50,
food
and
residential)
and
2,200
(children
1–
6
years
old,
food
and
residential).
These
aggregate
MOEs
do
not
exceed
the
Agency's
level
of
concern
for
aggregate
exposure
to
food
and
residential
uses.
In
addition,
shortterm
DWLOCs
were
calculated
and
compared
to
the
EECs
for
chronic
exposure
of
clopyralid
in
ground
and
surface
water.
After
calculating
DWLOCs
and
comparing
them
to
the
EECs
for
surface
and
ground
water,
EPA
does
not
expect
short
term
aggregate
exposure
to
exceed
the
Agency's
level
of
concern,
as
shown
in
the
following
Table
5:
TABLE
5.—
AGGREGATE
RISK
ASSESSMENT
FOR
SHORT
TERM
EXPOSURE
TO
CLOPYRALID
Population
Subgroup
Aggregate
MOE
(Food
+
Residential
Aggregate
Level
of
Concern
(LOC)
Surface
Water
EEC
(ppb)
Ground
Water
EEC
(ppb)
Short–
Term
DWLOC
(ppb)
U.
S.
Population
7,000
100
18
9.7
26,000
Children
1–
6
years
2,200
100
18
9.7
7,200
Females
13–
50
years
9,600
100
18
9.7
22,000
4.
Intermediate
term
risk.
Intermediate
term
aggregate
exposure
takes
into
account
residential
exposure
plus
chronic
exposure
to
food
and
water
(considered
to
be
a
background
exposure
level).
Clopyralid
is
currently
registered
for
use(
s)
that
could
result
in
intermediateterm
residential
exposure
and
the
Agency
has
determined
that
it
is
appropriate
to
aggregate
chronic
food
and
water
and
intermediate
term
exposures
for
clopyralid.
Using
the
exposure
assumptions
described
in
this
unit
for
intermediateterm
exposures,
EPA
has
concluded
that
food
and
residential
exposures
aggregated
result
in
an
aggregate
MOE
of
530
(children
1–
6
years,
food
and
residential).
This
aggregate
MOE
does
not
exceed
the
Agency's
level
of
concern
for
aggregate
exposure
to
food
and
residential
uses.
In
addition,
an
intermediate
term
DWLOC
was
calculated
and
compared
to
the
EECs
for
chronic
exposure
of
clopyralid
in
ground
and
surface
water.
After
calculating
the
DWLOC
and
comparing
it
to
the
EECs
for
surface
and
ground
water,
EPA
does
not
expect
intermediate
term
aggregate
exposure
to
exceed
the
Agency's
level
of
concern,
as
shown
in
the
following
Table
6:
TABLE
6.—
AGGREGATE
RISK
ASSESSMENT
FOR
INTERMEDIATE
TERM
EXPOSURE
TO
CLOPYRALID
Population
Subgroup
Aggregate
MOE
(Food
+
Residential
Aggregate
Level
of
Concern
(LOC)
Surface
Water
EEC
(ppb)
Ground
Water
+
EEC
(ppb)
IntermediateTerm
DWLOC
(ppb)
Children
1–
6
years
530
100
18
9.7
1,200
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Regulations
5.
Aggregate
cancer
risk
for
U.
S.
population.
The
Agency
concluded
that
clopyralid
was
negative
for
carcinogenicity
potential
in
rats
and
mice
and
classified
clopyralid
as
``
not
likely''
to
be
a
human
carcinogen
according
to
EPA
Draft
Guidelines
for
Carcinogen
Risk
Assessment.
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
clopyralid
residues.
IV.
Other
Considerations
A.
Analytical
Enforcement
Methodology
An
adequate
residue
analytical
method
is
available
for
enforcement
of
the
proposed
tolerances.
This
method,
ACR
75.6,
determines
clopyralid
as
the
methyl
ester
by
gas
chromatography
using
electron
capture
detection.
This
method
has
been
successfully
validated
by
EPA
and
has
been
published
in
FDA's
Pesticide
Analytical
Manual,
VolII
(PAM
II).
An
adequate
residue
analytical
method
is
also
available
for
the
enforcement
of
the
proposed
tolerance
on
animal
commodities.
This
method,
ACR
86.1,
determines
clopyralid
as
the
methyl
ester
by
gas
chromatography
using
electron
capture
detection.
This
method
has
been
successfully
validated
by
EPA
and
has
been
published
in
FDA's
Pesticide
Analytical
Manual,
VolII
(PAM
II).
B.
International
Residue
Limits
There
are
no
Codex
or
Mexican
maximum
residue
limits
(MRLs).
Canada
has
set
maximum
residue
limits
of
2.0
ppm
for
barley,
oats,
and
wheat,
7.0
ppm
for
the
milled
fractions
of
barley,
oats,
and
wheat
(excluding
flour),
1.0
ppm
for
strawberries
and
0.2
ppm
for
flax.
V.
Conclusion
Therefore,
tolerances
are
established
for
residues
of
clopyralid
on
strawberry
at
1.0
ppm;
hop,
dried
cones,
at
5.0
ppm;
rapeseed
seed,
rapeseed
forage,
mustard
seed,
and
crambe
seed
at
3.0
ppm,
canola
meal
and
flax
meal
at
6.0
ppm;
spinach
at
5.0
ppm;
stone
fruit
group
at
0.5
ppm;
prunes
at
1.5
ppm,
garden
beet
tops
at
3.0
ppm
and
garden
beet
roots
at
4.0
ppm;
mustard
greens
at
5.0
ppm;
turnip
roots
at
1.0
ppm
and
turnip
tops
at
4.0
ppm;
cranberry
at
4.0
ppm;
sweet
corn,
kernel
plus
cob
with
husks
removed
at
1.0
ppm,
sweet
corn
forage
at
7.0
ppm,
sweet
corn
stover
at
10.0
ppm,
pop
corn
grain
at
1.0
ppm,
pop
corn
stover
at
10.0
ppm,
liver
of
cattle,
goat,
horse,
and
sheep
at
3.0
ppm,
meat
byproducts,
except
liver,
of
cattle,
goat,
horse
and
sheep
at
36.0
ppm,
and
milk
at
0.2
ppm;
and
the
brassica,
head
and
stem,
subgroup
at
2.0
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
of
1996,
EPA
will
continue
to
use
those
procedures,
with
appropriate
adjustments,
until
the
necessary
modifications
can
be
made.
The
new
section
408(
g)
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),
as
was
provided
in
the
old
FFDCA
sections
408
and
409.
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
control
number
OPP–
2002–
0235
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
November
25,
2002.
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.
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.
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.
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.
2.
Mail
your
copies,
identified
by
docket
control
number
OPP–
2002–
0235,
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.
In
person
or
by
courier,
bring
a
copy
to
the
location
of
the
PIRIB
described
in
Unit
I.
B.
2.
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.
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186
/
Wednesday,
September
25,
2002
/
Rules
and
Regulations
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
FFDCA
section
408(
d)
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
FFDCA
section
408(
d),
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
FFDCA
section
408(
n)(
4).
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:
September
16,
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
374.
2.
Section
180.431
is
amended
as
follows:
i.
By
alphabetically
adding
commodities
to
the
table
in
paragraph
(a);
ii.
By
removing
tolerances
for
cattle,
kidney;
goat,
kidney;
horse,
kidney
and
sheep,
kidney
in
the
table
in
paragraph
(a);
iii.
By
increasing
tolerances
for
cattle,
meat
byproducts,
except
liver;
goat,
meat
byproducts,
except
liver;
horse,
meat
byproducts,
except
liver
and
sheep,
meat
byproducts,
except
liver;
and
milk
in
the
table
in
paragraph
(a);
and
iv.
By
removing
the
text
from
paragraph
(b);
and
reserving
paragraph
(b)
with
the
heading.
The
additions
and
revisions
read
as
follows:
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/
Vol.
67,
No.
186
/
Wednesday,
September
25,
2002
/
Rules
and
Regulations
§
180.431
Clopyralid;
tolerances
for
residues.
(a)
General.
Tolerances
are
established
for
residues
of
the
herbicide
clopyralid
(3,6
dichloro
2
pyridinecarboxylic
acid)
in
or
on
the
following
commodities:
Commodity
Parts
per
million
*****
Beet,
garden,
tops
..........
3.0
Beet,
garden,
roots
.........
4.0
Brassica,
head
and
stem,
subgroup
.....................
2.0
Canola,
meal
..................
6.0
Canola,
seed
..................
3.0
*****
Cattle,
liver
......................
3.0
*****
Cattle,
meat
byproducts,
except
liver
..................
36.0
*****
Corn,
pop,
grain
..............
1.0
Corn,
pop,
stover
............
10.0
Corn,
sweet,
forage
........
7.0
Corn,
sweet,
kernel
plus
cob
with
husks
removed
.........................
1.0
Corn,
sweet,
stover
........
10.0
Crambe,
seed
.................
3.0
Cranberry
........................
4.0
*****
Flax,
meal
.......................
6.0
Flax,
seed
.......................
3.0
Fruit,
stone,
group
..........
0.5
*****
Goat,
liver
.......................
3.0
*****
Goat,
meat
byproducts,
except
liver
..................
36.0
*****
Hop,
dried
cones
............
5.0
*****
Horse,
liver
.....................
3.0
*****
Horse,
meat
byproducts,
except
liver
..................
36.0
Milk
.................................
0.2
*****
Mustard,
greens
..............
5.0
Mustard,
seed
.................
3.0
*****
Plum,
prune,
dried
..........
1.5
*****
Rapeseed,
seed
.............
3.0
Rapeseed,
forage
...........
3.0
*****
Sheep,
liver
.....................
3.0
*****
Sheep,
meat
byproducts,
except
liver
..................
36.0
*****
Spinach
...........................
5.0
Strawberry
......................
1.0
*****
Turnip,
roots
...................
1.0
Turnip,
tops
.....................
4.0
*****
(b)
Section
18
emergency
exemptions.
[Reserved]
*
*
*
*
*
[FR
Doc.
02–
24232
Filed
9–
24–
02;
8:
45
am]
BILLING
CODE
6560–
50–
S
ENVIRONMENTAL
PROTECTION
AGENCY
40
CFR
Part
281
[FRL–
7381–
6]
Hawaii;
Final
Approval
of
State
Underground
Storage
Tank
Program
AGENCY:
Environmental
Protection
Agency.
ACTION:
Notice
of
final
determination
on
the
State
of
Hawaii's
application
for
final
approval.
SUMMARY:
The
State
of
Hawaii
has
applied
for
approval
of
its
Underground
Storage
Tank
Program
for
petroleum
and
hazardous
substances
under
Subtitle
I
of
the
Resource
Conservation
and
Recovery
Act
(RCRA).
The
Environmental
Protection
Agency
(EPA)
has
reviewed
Hawaii's
application
and
has
reached
a
final
determination
that
Hawaii's
Underground
Storage
Tank
Program
for
petroleum
and
hazardous
substances
satisfies
all
of
the
requirements
necessary
to
qualify
for
approval.
Thus,
the
EPA
is
granting
final
approval
to
the
State
of
Hawaii
to
operate
its
Underground
Storage
Tank
Program
for
petroleum
and
hazardous
substances.
EFFECTIVE
DATE:
Final
approval
for
the
State
of
Hawaii's
Underground
Storage
Tanks
Program
shall
be
effective
on
September
30,
2002.
FOR
FURTHER
INFORMATION
CONTACT:
Mr.
Norwood
Scott,
Underground
Storage
Tanks
Program
Office,
U.
S.
EPA,
Region
9,
75
Hawthorne
Street
(WST–
8),
San
Francisco,
California
94105,
Telephone:
(415)
972–
3373.
SUPPLEMENTARY
INFORMATION:
A.
Background
Section
9004
of
the
Resource
Conservation
and
Recovery
Act
(RCRA)
authorizes
the
Environmental
Protection
Agency
(EPA)
to
approve
state
Underground
Storage
Tank
Programs
to
operate
in
the
State
in
lieu
of
the
Federal
Underground
Storage
Tank
(UST)
Program.
To
qualify
for
final
authorization,
a
state's
Program
must:
(1)
Be
``
no
less
stringent''
than
the
Federal
Program
for
the
seven
elements
set
forth
at
RCRA
Section
9004(
a)(
1)
through
(7);
and
(2)
provide
for
adequate
enforcement
of
compliance
with
the
UST
standards
of
RCRA
Section
9004(
a).
Note
that
RCRA
Sections
9005
(on
information
gathering)
and
9006
(on
Federal
enforcement)
by
their
terms
apply
even
in
states
with
Programs
approved
by
the
EPA
under
RCRA
Section
9004.
Thus,
the
Agency
retains
its
authority
under
RCRA
Sections
9005
and
9006,
42
U.
S.
C.
6991d
and
6991e,
and
other
applicable
statutory
and
regulatory
provisions
to
undertake
inspections
and
enforcement
actions
in
approved
states.
With
respect
to
such
an
enforcement
action,
the
Agency
will
rely
on
Federal
sanctions,
Federal
inspection
authorities,
and
Federal
procedures
rather
than
the
state
authorized
analogues
to
these
provisions.
Moreover,
authorization
of
a
state
Program
is
a
prospective
action
only
and
an
authorized
state
Program
only
operates
in
lieu
of
the
Federal
Program
as
of
the
effective
date
of
the
authorization.
The
Agency
may
undertake
enforcement
of
the
Federal
requirements
for
violations
of
those
Federal
requirements
which
occurred
prior
to
the
effective
date
of
authorization
of
the
state's
Program.
In
this
case,
authorization
of
the
Hawaii
UST
Program
will
be
effective
on
September
30,
2002.
On
May
23,
2001,
the
State
of
Hawaii
submitted
an
official
application
to
obtain
final
program
approval
to
administer
the
Underground
Storage
Tank
Program
for
petroleum
and
hazardous
substances.
On
October
5,
2001,
the
EPA
published
a
tentative
decision
announcing
its
intent
to
grant
Hawaii
final
approval.
Further
background
on
the
tentative
decision
to
grant
approval
appears
at
66
FR
50963–
50966,
October
5,
2001.
Along
with
the
tentative
determination,
the
EPA
announced
the
availability
of
the
application
for
public
comment
and
the
date
of
a
public
hearing
on
the
application.
The
EPA
requested
advance
notice
for
testimony
and
reserved
the
right
to
cancel
the
public
hearing
for
lack
of
public
interest.
The
hearing
was
held
at
Kawananakoa
Middle
School
in
Honolulu,
Hawaii
on
November
13,
2001.
B.
Significant
Public
Comments
and
EPA's
Responses
Written
comments
regarding
the
EPA's
approval
of
Hawaii's
Underground
Storage
Tank
Program
were
received
during
the
comment
period
from
EnviroWatch,
Inc.
Oral
comments
regarding
the
EPA's
approval
of
Hawaii's
Underground
Storage
Tank
Program
were
received
during
the
public
hearing
from
Carroll
Cox,
President
of
EnviroWatch,
Inc.,
and
Joe
Ryan,
a
resident
of
Waimanalo.
Additionally,
in
April
2001,
prior
to
publication
of
EPA's
tentative
decision
to
authorize
Hawaii's
Underground
Storage
Tank
Program,
EPA
received
a
Petition
To
Withdraw
Hawaii
Certification
and
Title
VI
Complaint
of
Discriminatory
Acts
(Petition
to
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"license": "Public Domain",
"url": "https://downloads.regulations.gov/EPA-HQ-OPP-2002-0235-0001/content.txt"
} |
EPA-HQ-OPP-2002-0235-0002 | Rule | "2002-10-11T04:00:00" | Clopyralid; Pesticide Tolerance (Correction) | This
section
of
the
FEDERAL
REGISTER
contains
editorial
corrections
of
previously
published
Presidential,
Rule,
Proposed
Rule,
and
Notice
documents.
These
corrections
are
prepared
by
the
Office
of
the
Federal
Register.
Agency
prepared
corrections
are
issued
as
signed
documents
and
appear
in
the
appropriate
document
categories
elsewhere
in
the
issue.
Corrections
Federal
Register
63503
Vol.
67,
No.
198
Friday
October
11,
2002
DEPARTMENT
OF
AGRICULTURE
Agricultural
Marketing
Service
7
CFR
Parts
996,
997,
998,
and
999
[Docket
No.
FV02–
996–
1
IFR]
Establishment
of
Minimum
Quality
and
Handling
Standards
for
Domestic
and
Imported
Peanuts
Marketed
in
the
United
States
and
Termination
of
the
Peanut
Marketing
Agreement
and
Associated
Rules
and
Regulations
Correction
In
rule
document
02–
22700
beginning
on
page
57129
in
the
issue
of
Monday,
September
9,
2002,
make
the
following
correction:
On
page
57142,
in
the
table,
under
the
column
titled
``
Type
and
grade
category'',
in
the
third
entry
from
the
top,
the
table
is
corrected
in
part
to
read
as
set
forth
below.
MINIMUM
QUALITY
STANDARDS:
PEANUTS
FOR
HUMAN
CONSUMPTION—
WHOLE
KERNELS
AND
SPLITS:
MAXIMUM
LIMITATIONS
Type
and
grade
category
Unshelled
peanuts
and
damaged
kernels
(percent)
Unshelled
peanuts,
damaged
kernels
and
minor
defects
(percent)
Fall
through
Foreign
materials
(percent)
Moisture
(percent)
Sound
split
and
broken
kernels
Sound
whole
kernels
Total
Excluding
lots
of
``
splits''
Virginia
with
splits
(not
more
than
15%
sound
splits).
1.50
2.50
3.00%;
17
64
inch
round
screen.
3.00%;
15
64
×
1
inch
slot
screen.
4.00%
Both
screens.
.20
9.00
[FR
Doc.
C2–
22700
Filed
10–
10–
02;
8:
45
am]
BILLING
CODE
1505–
01–
D
ENVIRONMENTAL
PROTECTION
AGENCY
40
CFR
Part
180
[OPP–
2002–
0235;
FRL–
7198–
4]
Clopyralid;
Pesticide
Tolerance
Correction
In
rule
document
02–
24232
beginning
on
page
60152,
in
the
issue
of
Wednesday,
September
25,
2002,
make
the
following
correction:
On
page
60154,
in
Table
1,
in
the
second
and
third
entries
from
the
bottom,
the
table
is
corrected
in
part
to
read
as
set
forth
below.
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17:
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Federal
Register
/
Vol.
67,
No.
198
/
Friday
October
11,
2002
/
Corrections
TABLE
1.—
SUBCHRONIC,
CHRONIC,
AND
OTHER
TOXICITY
OF
CLOPYRALID
Guideline
No.
Study
Type
Results
870.5450
Dominant
lethal
assay
in
rats.
No
evidence
of
treatment
related
resorptions
up
to
400
mg/
kg/
day
for
5
days.
870.5550
In
vitro
unscheduled
DNA
synthesis
assay
There
was
no
evidence
of
unscheduled
DNA
synthesis
in
initial
or
supplementary
assays
[FR
Doc.
C2–
24232
Filed
10–
10–
02;
8:
45
am]
BILLING
CODE
1505–
01–
D
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02>
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21:
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10,
2002
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| epa | 2024-06-07T20:31:43.424426 | regulations | {
"license": "Public Domain",
"url": "https://downloads.regulations.gov/EPA-HQ-OPP-2002-0235-0002/content.txt"
} |
EPA-HQ-OPP-2002-0235-0003 | Supporting & Related Material | "2002-10-24T04:00:00" | null | 65314
Federal
Register
/
Vol.
67,
No.
206
/
Thursday,
October
24,
2002
/
Rules
and
Regulations
(c)
Enforcement.
The
regulation
in
this
section,
promulgated
by
the
United
States
Army
Corps
of
Engineers,
shall
be
enforced
by
the
United
States
Navy,
Commanding
Officer
Naval
Station
Newport,
and/
or
such
agencies
or
persons
as
he/
she
may
designate.
Dated:
September
26,
2002.
Michael
G.
Ensch,
Acting
Chief,
Operations
Division,
Directorate
of
Civil
Works.
[FR
Doc.
02–
26646
Filed
10–
23–
02;
8:
45
am]
BILLING
CODE
3710–
92–
P
ENVIRONMENTAL
PROTECTION
AGENCY
40
CFR
Part
180
[OPP–
2002–
0235;
FRL–
7276–
9]
Clopyralid;
Pesticide
Tolerance
Technical
Correction
AGENCY:
Environmental
Protection
Agency
(EPA).
ACTION:
Final
rule;
technical
correction.
SUMMARY:
EPA
issued
a
final
rule
in
the
Federal
Register
of
September
25,
2002,
establishing
tolerances
for
clopyralid.
This
document
is
being
issued
to
correct
unnecessary
tolerances
for
meat
byproducts
except
kidney
of
cattle,
goats,
horses,
and
sheep
at
1.0
parts
per
million.
DATES:
This
regulation
is
effective
October
24,
2002.
FOR
FURTHER
INFORMATION
CONTACT:
By
mail:
Joanne
I.
Miller,
Registration
Division
(7505C),
Office
of
Pesticide
Programs,
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460;
telephone
number:
(703)
305–
6224;
and
e
mail
address:
miller.
joanne@
epamail.
epa.
gov
SUPPLEMENTARY
INFORMATION:
I.
Does
this
Action
Apply
to
Me?
The
Agency
included
in
the
final
rule
a
list
of
those
who
may
be
potentially
affected
by
the
action.
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–
0235.
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.
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.
III.
What
Does
this
Technical
Correction
Do?
Tolerances
for
clopyralid
on
various
commodities
were
published
in
the
Federal
Register
on
September
25,
2002
(67
FR
60152)
(FRL–
7198–
4)
including
meat
byproducts
except
liver
of
cattle,
goats,
horses
and
sheep
at
36.0
parts
per
million.
These
tolerances
superseded
tolerances
previously
established
for
meat
byproducts
except
kidney
of
cattle,
goats,
horses
and
sheep
at
1.0
ppm.
This
technical
correction
removes
the
lower
tolerances
from
§
180.431.
IV.
Why
is
this
Correction
Issued
as
a
Final
Rule?
Section
553
of
the
Administrative
Procedure
Act
(APA),
5
U.
S.
C.
553(
b)(
B),
provides
that,
when
an
Agency
for
good
cause
finds
that
notice
and
public
procedure
are
impracticable,
unnecessary
or
contrary
to
the
public
interest,
the
agency
may
issue
a
final
rule
without
providing
notice
and
an
opportunity
for
public
comment.
EPA
has
determined
that
there
is
good
cause
for
making
today's
technical
correction
final
without
prior
proposal
and
opportunity
for
comment,
because
EPA
is
merely
correcting
the
section
to
remove
certain
commodities
from
the
previously
published
final
rule.
EPA
finds
that
this
constitutes
good
cause
under
5
U.
S.
C.
553(
b)(
B).
V.
Do
Any
of
the
Regulatory
Assessment
Requirements
Apply
to
this
Action?
This
action
corrects
tolerances
established
under
section
408(
e)
of
the
Federal
Food,
Drug,
and
Cosmetic
Act
(FFDCA).
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
technical
correction
has
been
exempted
from
review
under
Executive
Order
12866
due
to
its
lack
of
significance,
this
technical
correction
is
not
subject
to
Executive
Order
13211,
entitled
Actions
Concerning
Regulations
That
Significantly
Affect
Energy
Supply,
Distribution,
or
Use
(66
FR
28355,
May
22,
2001).
In
addition,
this
technical
correction
does
not
contain
any
information
collections
subject
to
OMB
approval
under
the
Paperwork
Reduction
Act,
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
(Public
Law
104–
4).
Nor
does
it
require
any
prior
consultation
as
specified
by
Executive
Order
12875,
entitled
Enhancing
the
Intergovernmental
Partnership
(58
FR
58093,
October
28,
1993),
or
special
considerations
as
required
by
Executive
Order
12898,
entitled
Federal
Actions
to
Address
Environmental
Justice
in
Minority
Populations
and
Low
Income
Populations
(59
FR
7629,
February
16,
1994),
or
require
OMB
review
in
accordance
with
Executive
Order
13045,
entitled
Protection
of
Children
from
Environmental
Health
Risks
and
Safety
Risks
(62
FR
19885,
April
23,
1997).
In
addition,
under
the
Regulatory
Flexibility
Act
(5
U.
S.
C.
601
et
seq.),
the
Agency
previously
assessed
whether
establishing
tolerances,
exemptions
from
tolerances,
raising
tolerance
levels,
or
expanding
exemptions
might
adversely
impact
small
entities
and
concluded,
as
a
generic
matter,
that
there
is
no
adverse
economic
impact.
The
factual
basis
for
the
Agency's
generic
certification
for
tolerance
actions
published
on
May
4,
1981
(46
FR
24950),
and
was
provided
to
the
Chief
Counsel
for
Advocacy
of
the
Small
Business
Administration.
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Federal
Register
/
Vol.
67,
No.
206
/
Thursday,
October
24,
2002
/
Rules
and
Regulations
VI.
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:
October
4,
2002.
Peter
Caukins,
Acting
Director,
Registration
Division,
Office
of
Pesticide
Programs
Therefore,
40
CFR
part
180
is
corrected
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.
§
180.431
[Amended]
2.
In
§
180.431,
in
paragraph
(a),
the
table
is
amended
by
removing
the
entries
for
``
cattle,
meat
byproducts,
except
kidney'';
``
goats,
meat
byproducts,
except
kidney'';
``
horses,
meat
byproducts,
except
kidney'';
and
``
sheep,
meat
byproducts,
except
kidney.
''
[FR
Doc.
02–
27132
Filed
10–
23–
02;
8:
45
am]
BILLING
CODE
6560–
50–
S
ENVIRONMENTAL
PROTECTION
AGENCY
40
CFR
Part
300
[FRL–
7399–
6]
National
Priorities
List
for
Uncontrolled
Hazardous
Waste
Sites
AGENCY:
Environmental
Protection
Agency.
ACTION:
Final
rule.
SUMMARY:
The
Comprehensive
Environmental
Response,
Compensation,
and
Liability
Act
of
1980
(``
CERCLA''
or
``
the
Act''),
as
amended,
requires
that
the
National
Oil
and
Hazardous
Substances
Pollution
Contingency
Plan
(``
NCP'')
include
a
list
of
national
priorities
among
the
known
releases
or
threatened
releases
of
hazardous
substances,
pollutants,
or
contaminants
throughout
the
United
States.
The
National
Priorities
List
(``
NPL'')
constitutes
this
list.
The
NPL
is
intended
primarily
to
guide
the
Environmental
Protection
Agency
(``
EPA''
or
``
the
Agency'')
in
determining
which
sites
warrant
further
investigation.
These
further
investigations
will
allow
EPA
to
assess
the
nature
and
extent
of
public
health
and
environmental
risks
associated
with
the
site
and
to
determine
what
CERCLAfinanced
remedial
action(
s),
if
any,
may
be
appropriate.
This
rule
adds
one
new
site
to
the
NPL;
the
Libby
Asbestos
site
located
in
Libby,
Montana.
It
is
being
added
to
the
General
Superfund
Section
of
the
NPL.
EFFECTIVE
DATE:
The
effective
date
for
this
amendment
to
the
NCP
shall
be
November
25,
2002.
ADDRESSES:
For
addresses
for
the
Headquarters
and
Regional
dockets,
as
well
as
further
details
on
what
these
dockets
contain,
see
section
II,
``
Availability
of
Information
to
the
Public''
in
the
SUPPLEMENTARY
INFORMATION
portion
of
this
preamble.
FOR
FURTHER
INFORMATION
CONTACT:
Yolanda
Singer,
phone
(703)
603–
8835,
State,
Tribal
and
Site
Identification
Center;
Office
of
Emergency
and
Remedial
Response
(mail
code
5204G);
U.
S.
Environmental
Protection
Agency;
1200
Pennsylvania
Avenue
NW;
Washington,
DC
20460;
or
the
Superfund
Hotline,
phone
(800)
424–
9346
or
(703)
412–
9810
in
the
Washington,
DC,
metropolitan
area.
SUPPLEMENTARY
INFORMATION:
Table
of
Contents
I.
Background
A.
What
Are
CERCLA
and
SARA?
B.
What
Is
the
NCP?
C.
What
Is
the
National
Priorities
List
(NPL)?
D.
How
Are
Sites
Listed
on
the
NPL?
E.
What
Happens
to
Sites
on
the
NPL?
F.
How
Are
Site
Boundaries
Defined?
G.
How
Are
Sites
Removed
From
the
NPL?
H.
Can
Portions
of
Sites
Be
Deleted
From
the
NPL
as
They
Are
Cleaned
Up?
I.
What
Is
the
Construction
Completion
List
(CCL)?
II.
Availability
of
Information
to
the
Public
A.
Can
I
Review
the
Documents
Relevant
to
This
Final
Rule?
B.
What
Documents
Are
Available
for
Review
at
the
Headquarters
and
Region
8
Dockets?
C.
How
Do
I
Access
the
Documents?
D.
How
Can
I
Obtain
a
Current
List
of
NPL
Sites?
III.
Contents
of
This
Final
Rule
A.
Addition
to
the
NPL
B.
Status
of
NPL
C.
What
Did
EPA
Do
With
the
Public
Comments
It
Received?
IV.
Executive
Order
12866
A.
What
Is
Executive
Order
12866?
B.
Is
This
Final
Rule
Subject
to
Executive
Order
12866
Review?
V.
Unfunded
Mandates
A.
What
Is
the
Unfunded
Mandates
Reform
Act
(UMRA)?
B.
Does
UMRA
Apply
to
This
Final
Rule?
VI.
Effects
on
Small
Businesses
A.
What
Is
the
Regulatory
Flexibility
Act?
B.
How
Has
EPA
Complied
With
the
Regulatory
Flexibility
Act?
VII.
Possible
Changes
to
the
Effective
Date
of
the
Rule
A.
Has
This
Rule
Been
Submitted
to
Congress
and
the
General
Accounting
Office?
B.
Could
the
Effective
Date
of
This
Final
Rule
Change?
C.
What
Could
Cause
the
Effective
Date
of
This
Rule
to
Change?
VIII.
National
Technology
Transfer
and
Advancement
Act
A.
What
Is
the
National
Technology
Transfer
and
Advancement
Act?
B.
Does
the
National
Technology
Transfer
and
Advancement
Act
Apply
to
This
Final
Rule?
IX.
Executive
Order
12898
A.
What
Is
Executive
Order
12898?
B.
Does
Executive
Order
12898
Apply
to
This
Final
Rule?
X.
Executive
Order
13045
A.
What
Is
Executive
Order
13045?
B.
Does
Executive
Order
13045
Apply
to
This
Final
Rule?
XI.
Paperwork
Reduction
Act
A.
What
Is
the
Paperwork
Reduction
Act?
B.
Does
the
Paperwork
Reduction
Act
Apply
to
This
Final
Rule?
XII.
Executive
Orders
on
Federalism
What
Are
The
Executive
Orders
on
Federalism
and
Are
They
Applicable
to
This
Final
Rule?
XIII.
Executive
Order
13084
What
Is
Executive
Order
13084
and
Is
It
Applicable
to
This
Final
Rule?
XIV.
Executive
Order
13175
A.
What
Is
Executive
Order
13175?
B.
Does
Executive
Order
13175
Apply
to
This
Final
Rule?
XV.
Executive
Order
13211
A.
What
Is
Executive
Order
13211?
B.
Is
This
Rule
Subject
to
Executive
Order
13211?
I.
Background
A.
What
Are
CERCLA
and
SARA?
In
1980,
Congress
enacted
the
Comprehensive
Environmental
Response,
Compensation,
and
Liability
Act,
42
U.
S.
C.
9601–
9675
(``
CERCLA''
or
``
the
Act''),
in
response
to
the
dangers
of
uncontrolled
releases
of
hazardous
substances.
CERCLA
was
amended
on
October
17,
1986,
by
the
Superfund
Amendments
and
Reauthorization
Act
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} |
EPA-HQ-OPP-2002-0237-0001 | Rule | "2002-12-06T05:00:00" | Cyromazine; Pesticide Tolerance | 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:
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/
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
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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
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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
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2002
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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.
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235
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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.
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/
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
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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
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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.
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| epa | 2024-06-07T20:31:43.436765 | regulations | {
"license": "Public Domain",
"url": "https://downloads.regulations.gov/EPA-HQ-OPP-2002-0237-0001/content.txt"
} |
EPA-HQ-OPP-2002-0244-0007 | Notice | "2002-10-09T04:00:00" | Notice of Filing a Pesticide Petition to Establish a Tolerance for a Certain Pesticide Chemical in or on
Food. (FRL 7196-2 )
| 62971
Federal
Register
/
Vol.
67,
No.
196
/
Wednesday,
October
9,
2002
/
Notices
ENVIRONMENTAL
PROTECTION
AGENCY
[OPP–
2002–
0244;
FRL–
7196––
2]
Notice
of
Filing
a
Pesticide
Petition
to
Establish
a
Tolerance
for
a
Certain
Pesticide
Chemical
in
or
on
Food
AGENCY:
Environmental
Protection
Agency
(EPA).
ACTION:
Notice.
SUMMARY:
This
notice
announces
the
initial
filing
of
a
pesticide
petition
proposing
the
establishment
of
regulations
for
residues
of
a
certain
pesticide
chemical
in
or
on
various
food
commodities.
DATES:
Comments,
identified
by
docket
ID
number
OPP–
2002–
0244,
must
be
received
on
or
before
November
8,
2002.
ADDRESSES:
Comments
may
be
submitted
electronically,
by
mail,
or
through
hand
delivery/
courier.
Follow
the
detailed
instructions
as
provided
in
Unit
I.
of
the
SUPPLEMENTARY
INFORMATION.
To
ensure
proper
receipt
by
EPA,
it
is
imperative
that
you
identify
docket
ID
number
OPP–
2002–
0244
in
the
subject
line
on
the
first
page
of
your
response.
FOR
FURTHER
INFORMATION
CONTACT:
By
mail:
Leonard
Cole,
Biopesticide
and
Pollution
Prevention
Division,
Office
of
Pesticide
Programs,
(7511C)
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460;
telephone
number:
(703)
305–
5412;
e
mail
address:
cole.
leonard@
epa.
gov.
SUPPLEMENTARY
INFORMATION:
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:
Categories
NAICS
codes
Examples
of
potentially
affected
entities
Industry
111
Crop
production
112
Animal
production
311
Food
manufacturing
32532
Pesticide
manufacturing
This
listing
is
not
intended
to
be
exhaustive,
but
rather
provides
a
guide
for
readers
regarding
entities
likely
to
be
affected
by
this
action.
Other
types
of
entities
not
listed
in
this
unit
could
also
be
affected.
The
North
American
Industrial
Classification
System
(NAICS)
codes
have
been
provided
to
assist
you
and
others
in
determining
whether
this
action
might
apply
to
certain
entities.
To
determine
whether
you
or
your
business
may
be
affected
by
this
action,
you
should
carefully
examine
the
applicability
provisions
in
OPP–
2002–
0244.
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–
0244.
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/.
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.
Certain
types
of
information
will
not
be
placed
in
the
EPA
Dockets.
Information
claimed
as
CBI
and
other
information
whose
disclosure
is
restricted
by
statute,
which
is
not
included
in
the
official
public
docket,
will
not
be
available
for
public
viewing
in
EPA's
electronic
public
docket.
EPA's
policy
is
that
copyrighted
material
will
not
be
placed
in
EPA's
electronic
public
docket
but
will
be
available
only
in
printed,
paper
form
in
the
official
public
docket.
To
the
extent
feasible,
publicly
available
docket
materials
will
be
made
available
in
EPA's
electronic
public
docket.
When
a
document
is
selected
from
the
index
list
in
EPA
Dockets,
the
system
will
identify
whether
the
document
is
available
for
viewing
in
EPA's
electronic
public
docket.
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.
EPA
intends
to
work
towards
providing
electronic
access
to
all
of
the
publicly
available
docket
materials
through
EPA's
electronic
public
docket.
For
public
commenters,
it
is
important
to
note
that
EPA's
policy
is
that
public
comments,
whether
submitted
electronically
or
in
paper,
will
be
made
available
for
public
viewing
in
EPA's
electronic
public
docket
as
EPA
receives
them
and
without
change,
unless
the
comment
contains
copyrighted
material,
CBI,
or
other
information
whose
disclosure
is
restricted
by
statute.
When
EPA
identifies
a
comment
containing
copyrighted
material,
EPA
will
provide
a
reference
to
that
material
in
the
version
of
the
comment
that
is
placed
in
EPA's
electronic
public
docket.
The
entire
printed
comment,
including
the
copyrighted
material,
will
be
available
in
the
public
docket.
Public
comments
submitted
on
computer
disks
that
are
mailed
or
delivered
to
the
docket
will
be
transferred
to
EPA's
electronic
public
docket.
Public
comments
that
are
mailed
or
delivered
to
the
docket
will
be
scanned
and
placed
in
EPA's
electronic
public
docket.
Where
practical,
physical
objects
will
be
photographed,
and
the
photograph
will
be
placed
in
EPA's
electronic
public
docket
along
with
a
brief
description
written
by
the
docket
staff.
C.
How
and
To
Whom
Do
I
Submit
Comments?
You
may
submit
comments
electronically,
by
mail,
or
through
hand
delivery/
courier.
To
ensure
proper
receipt
by
EPA,
identify
the
appropriate
docket
ID
number
in
the
subject
line
on
the
first
page
of
your
comment.
Please
ensure
that
your
comments
are
submitted
within
the
specified
comment
period.
Comments
received
after
the
close
of
the
comment
period
will
be
marked
``
late.
''
EPA
is
not
required
to
consider
these
late
comments.
If
you
wish
to
submit
CBI
or
information
that
is
otherwise
protected
by
statute,
please
follow
the
instructions
in
Unit
I.
D.
Do
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/
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October
9,
2002
/
Notices
not
use
EPA
Dockets
or
e
mail
to
submit
CBI
or
information
protected
by
statute.
1.
Electronically.
If
you
submit
an
electronic
comment
as
prescribed
in
this
unit,
EPA
recommends
that
you
include
your
name,
mailing
address,
and
an
email
address
or
other
contact
information
in
the
body
of
your
comment.
Also
include
this
contact
information
on
the
outside
of
any
disk
or
CD
ROM
you
submit,
and
in
any
cover
letter
accompanying
the
disk
or
CD
ROM.
This
ensures
that
you
can
be
identified
as
the
submitter
of
the
comment
and
allows
EPA
to
contact
you
in
case
EPA
cannot
read
your
comment
due
to
technical
difficulties
or
needs
further
information
on
the
substance
of
your
comment.
EPA's
policy
is
that
EPA
will
not
edit
your
comment,
and
any
identifying
or
contact
information
provided
in
the
body
of
a
comment
will
be
included
as
part
of
the
comment
that
is
placed
in
the
official
public
docket,
and
made
available
in
EPA's
electronic
public
docket.
If
EPA
cannot
read
your
comment
due
to
technical
difficulties
and
cannot
contact
you
for
clarification,
EPA
may
not
be
able
to
consider
your
comment.
i.
EPA
Dockets.
Your
use
of
EPA's
electronic
public
docket
to
submit
comments
to
EPA
electronically
is
EPA's
preferred
method
for
receiving
comments.
Go
directly
to
EPA
Dockets
at
http://
www.
epa.
gov/
edocket,
and
follow
the
online
instructions
for
submitting
comments.
Once
in
the
system,
select
``
search,
''
and
then
key
in
docket
ID
number
OPP–
2002–
0244
The
system
is
an
``
anonymous
access''
system,
which
means
EPA
will
not
know
your
identity,
e
mail
address,
or
other
contact
information
unless
you
provide
it
in
the
body
of
your
comment.
ii.
E
mail.
Comments
may
be
sent
by
e
mail
to
opp
docket@
epa.
gov,
Attention:
Docket
ID
Number
OPP–
2002–
0244.
In
contrast
to
EPA's
electronic
public
docket,
EPA's
e
mail
system
is
not
an
``
anonymous
access''
system.
If
you
send
an
e
mail
comment
directly
to
the
docket
without
going
through
EPA's
electronic
public
docket,
EPA's
e
mail
system
automatically
captures
your
e
mail
address.
E
mail
addresses
that
are
automatically
captured
by
EPA's
e
mail
system
are
included
as
part
of
the
comment
that
is
placed
in
the
official
public
docket,
and
made
available
in
EPA's
electronic
public
docket.
iii.
Disk
or
CD
ROM.
You
may
submit
comments
on
a
disk
or
CD
ROM
that
you
mail
to
the
mailing
address
identified
in
Unit
I.
C.
2.
These
electronic
submissions
will
be
accepted
in
WordPerfect
or
ASCII
file
format.
Avoid
the
use
of
special
characters
and
any
form
of
encryption.
2.
By
mail.
Send
your
comments
to:
Public
Information
and
Records
Integrity
Branch
(PIRIB)
(7502C),
Office
of
Pesticide
Programs
(OPP),
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC,
20460–
0001,
Attention:
Docket
ID
Number
OPP–
2002–
0244.
3.
By
hand
delivery
or
courier.
Deliver
your
comments
to:
Public
Information
and
Records
Integrity
Branch
(PIRIB),
Office
of
Pesticide
Programs
(OPP),
Environmental
Protection
Agency,
Rm.
119,
Crystal
Mall
#2,
1921
Jefferson
Davis
Hwy.,
Arlington,
VA,
Attention:
Docket
ID
Number
OPP–
2002–
0244.
Such
deliveries
are
only
accepted
during
the
docket's
normal
hours
of
operation
as
identified
in
Unit
I.
B.
1.
D.
How
Should
I
Submit
CBI
to
the
Agency?
Do
not
submit
information
that
you
consider
to
be
CBI
electronically
through
EPA's
electronic
public
docket
or
by
e
mail.
You
may
claim
information
that
you
submit
to
EPA
as
CBI
by
marking
any
part
or
all
of
that
information
as
CBI
(if
you
submit
CBI
on
disk
or
CD
ROM,
mark
the
outside
of
the
disk
or
CD
ROM
as
CBI
and
then
identify
electronically
within
the
disk
or
CD
ROM
the
specific
information
that
is
CBI).
Information
so
marked
will
not
be
disclosed
except
in
accordance
with
procedures
set
forth
in
40
CFR
part
2.
In
addition
to
one
complete
version
of
the
comment
that
includes
any
information
claimed
as
CBI,
a
copy
of
the
comment
that
does
not
contain
the
information
claimed
as
CBI
must
be
submitted
for
inclusion
in
the
public
docket
and
EPA's
electronic
public
docket.
If
you
submit
the
copy
that
does
not
contain
CBI
on
disk
or
CD
ROM,
mark
the
outside
of
the
disk
or
CD
ROM
clearly
that
it
does
not
contain
CBI.
Information
not
marked
as
CBI
will
be
included
in
the
public
docket
and
EPA's
electronic
public
docket
without
prior
notice.
If
you
have
any
questions
about
CBI
or
the
procedures
for
claiming
CBI,
please
consult
the
person
listed
under
FOR
FURTHER
INFORMATION
CONTACT.
E.
What
Should
I
Consider
as
I
Prepare
My
Comments
for
EPA?
You
may
find
the
following
suggestions
helpful
for
preparing
your
comments:
1.
Explain
your
views
as
clearly
as
possible.
2.
Describe
any
assumptions
that
you
used.
3.
Provide
copies
of
any
technical
information
and/
or
data
you
used
that
support
your
views.
4.
If
you
estimate
potential
burden
or
costs,
explain
how
you
arrived
at
the
estimate
that
you
provide.
5.
Provide
specific
examples
to
illustrate
your
concerns.
6.
Offer
alternative
ways
to
improve
the
notice
or
collection
activity.
7.
Make
sure
to
submit
your
comments
by
the
deadline
in
this
document.
8.
To
ensure
proper
receipt
by
EPA,
be
sure
to
identify
the
docket
ID
number
assigned
to
this
action
in
the
subject
line
on
the
first
page
of
your
response.
You
may
also
provide
the
name,
date,
and
Federal
Register
citation.
II.
What
Action
is
the
Agency
Taking?
EPA
has
received
a
pesticide
petition
as
follows
proposing
the
establishment
and/
or
amendment
of
regulations
for
residues
of
a
certain
pesticide
chemical
in
or
on
various
food
commodities
under
section
408
of
the
Federal
Food,
Drug,
and
Cosmetic
Act
(FFDCA),
21
U.
S.
C.
346a.
EPA
has
determined
that
this
petition
contains
data
or
information
regarding
the
elements
set
forth
in
section
408(
d)(
2);
however,
EPA
has
not
fully
evaluated
the
sufficiency
of
the
submitted
data
at
this
time
or
whether
the
data
support
granting
of
the
petition.
Additional
data
may
be
needed
before
EPA
rules
on
the
petition.
List
of
Subjects
Environmental
protection,
Agricultural
commodities,
Feed
additives,
Food
additives,
Pesticides
and
pests,
Reporting
and
recordkeeping
requirements.
September
24,
2002.
Janet
L.
Andersen,
Director,
Biopesticide
and
Pollution
Prevention
Division,
Office
of
Pesticide
Programs.
Summary
of
Petition
The
petitioner
summary
of
the
pesticide
petition
is
printed
below
as
required
by
section
408(
d)(
3)
of
the
FFDCA.
The
summary
of
the
petition
was
prepared
by
Mycogen
Seeds
c/
o
Dow
AgroSciences
LLC,
and
represents
the
view
of
the
Mycogen
Seeds.
The
petition
summary
announces
the
availability
of
a
description
of
the
analytical
methods
available
to
EPA
for
the
detection
and
measurement
of
the
pesticide
chemical
residues,
or
an
explanation
of
why
no
such
method
is
needed.
Mycogen
Seeding
c/
o
Dow
AgroSciences
LLC
PP
2G6494
EPA
has
received
a
pesticide
petition
(2G6494)
from
Mycogen
Seeds
c/
o
Dow
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2002
/
Notices
AgroSciences
LLC,
9330
Zionsville
Road,
Indianapolis,
IN
46268–
1054,
proposing
pursuant
to
section
408(
d)
of
the
FFDCA,
21
U.
S.
C.
346a(
d),
to
amend
40
CFR
part
180,
to
establish
an
exemption
from
the
requirement
of
a
temporary
tolerance
for
the
plant
incorporated
protantant;
bacillus
thuringiensis
var
Kurstaki
CrylAc
in
or
on
cotton.
The
plant
also
expresses
the
Cry1F
protein
(refer
to
FRL–
7198–
2
published
elsewhere
in
this
issue
of
the
Federal
Register).
Pursuant
to
section
408(
d)(
2)(
A)(
i)
of
the
FFDCA,
as
amended,
Mycogen
Seeds
c/
o
Dow
AgroSciences
LLC
has
submitted
the
following
summary
of
information,
data,
and
arguments
in
support
of
their
pesticide
petition.
EPA
has
not
fully
evaluated
the
merits
of
the
pesticide
petition.
The
summary
may
have
been
edited
by
EPA
if
the
terminology
used
was
unclear,
the
summary
contained
extraneous
material,
or
the
summary
unintentionally
made
the
reader
conclude
that
the
findings
reflected
EPA's
position
and
not
the
position
of
the
petitioner.
A.
Product
Name
and
Proposed
Use
Practices
Bacillus
thuringiensis
subspecies
kurstaki.
Cry1Ac
(synpro)
insect
control
protein
is
expressed
in
cotton
plants
to
provide
protection
from
key
lepidopteran
insect
pests
such
as
the
tobacco
budworm
and
pink
bollworm.
Cry1Ac
(synpro)
transgenic
plants
are
derived
from
transformation
events
that
contain
the
insecticidal
gene
via
a
plasmid
insert.
The
Cry1Ac
(synpro)
protein
poses
no
foreseeable
risks
to
non
target
organisms
including
mammals,
birds,
fish,
beneficial
insects,
and
earthworms.
Cry1Ac
(synpro)
protected
cotton
provides
growers
with
a
highly
efficacious
tool
for
controlling
important
insect
pests
in
cotton
in
a
manner
that
is
fully
compatible
with
integrated
pest
management
practices.
B.
Product
Identity/
Chemistry
1.
Identity
of
the
pesticide
and
corresponding
residues.
The
Cry1Ac
gene
was
isolated
from
bacillus
thuringiensis
subspecies
kurstaki
and
modified
before
it
was
inserted
into
cotton
plants
to
produce
a
full
length
protein.
The
Cry1Ac
(synpro)
insecticidal
protein
has
been
adequately
characterized.
Several
safety
studies
were
conducted
using
a
microbially
produced
test
substance
preparation
that
contained
14%
Cry1Ac
protein.
Studies
conducted
to
establish
the
equivalence
of
the
Cry1Ac
(synpro)
protein
obtained
from
cotton,
or
from
a
microbial
source
demonstrate
that
the
materials
are
similar
with
respect
to
molecular
weight,
immunoreactivity,
lack
of
post
translational
glycosylation
and
spectrum
of
bioactivity.
2.
A
statement
of
why
an
analytical
method
for
detecting
and
measuring
the
levels
of
the
pesticide
residue
are
not
needed.
No
analytical
method
is
included
because
this
petition
requests
a
temporary
exemption
from
the
requirement
for
a
tolerance.
C.
Mammalian
Toxicological
Profile
Cry
proteins
have
been
deployed
as
safe
and
effective
pest
control
agents
in
microbial
bacillus
thuringiensis
formulations
for
almost
40
years.
There
are
currently
180
registered
microbial
bacillus
thuringiensis
products
in
the
United
States
for
use
in
agriculture,
forestry,
and
vector
control.
The
numerous
toxicology
studies
conducted
with
these
microbial
products
show
no
significant
adverse
effects,
and
demonstrate
that
the
products
are
practically
non
toxic
to
mammals.
An
exemption
from
the
requirement
of
a
tolerance
has
been
in
place
for
these
products
since
at
least
1971
(40
CFR
180.1011).
Toxicology
studies
conducted
to
determine
the
toxicity
of
Cry1Ac
(synpro)
insecticidal
crystal
protein
demonstrated
that
the
protein
has
very
low
toxicity.
In
an
acute
oral
toxicity
study
in
the
mouse
(male
and
female),
the
estimated
acute
LD50
was
determined
to
be
>
5,000
mg/
kg
of
the
microbially
produced
test
substance
containing
14%
Cry1Ac
(synpro)
protein.
In
an
in
vitro
study,
Cry1Ac
(synpro)
protein
was
rapidly
and
extensively
degraded
in
simulated
gastric
conditions
in
the
presence
of
pepsin
at
pH
1.2.
Cry1Ac
(synpro)
was
completely
proteolyzed
to
amino
acids
and
small
peptide
fragments
in
<
1
minute.
This
indicates
that
the
protein
is
highly
susceptible
to
digestion
in
the
human
digestive
tract
and
that
the
potential
for
adverse
health
effects
from
chronic
exposure
is
virtually
nonexistent.
Moreover,
proteins
in
general
are
not
known
to
be
carcinogenic.
A
search
of
relevant
data
bases
indicated
that
the
amino
acid
sequence
of
the
Cry1Ac
(synpro)
protein
exhibits
no
significant
homology
to
the
sequences
of
known
allergens
or
protein
toxins.
Thus,
Cry1Ac
(synpro)
is
highly
unlikely
to
exhibit
an
allergic
response.
The
results
of
a
study
to
determine
the
lability
of
the
Cry1Ac
(synpro)
protein
to
heat
demonstrated
that
the
protein
was
deactivated
after
exposure
to
75
o
C
or
90
o
C
for
30
minutes,
according
to
bioassay
results
on
tobacco
budworm.
The
genetic
material
necessary
for
the
production
of
the
Cry1Ac
(synpro)
insecticidal
crystal
protein
are
nucleic
acids
(DNA)
which
are
common
to
all
forms
of
plant
and
animal
life.
There
are
no
known
instances
of
where
nucleic
acids
have
caused
toxic
effects
as
a
result
of
dietary
exposure.
Collectively,
the
available
data
on
Cry1Ac
(synpro)
protein
along
with
the
safe
use
history
of
microbial
bacillus
thuringiensis
products,
establishes
the
safety
of
the
plant
pesticide
bacillus
thuringiensis
subspecies
kurstaki,
Cry1Ac
(synpro)
insecticidal
crystal
protein
and
the
genetic
material
necessary
for
its
production
in
all
raw
agricultural
commodities.
D.
Aggregate
Exposure
Insecticidal
crystal
proteins
of
bacillus
thuringiensis
are
known
to
have
a
high
degree
of
insect
specificity
via
binding
to
specific
receptors
in
the
insect
gut,
and
do
not
harm
people,
wildlife
or
many
beneficial
insects
(Ballester
et
al.,
1999;
Aronson
and
Shai,
2001).
The
level
of
protein
that
is
expressed
in
corn
plants
is
very
low.
The
small
amount
of
Cry1Ac
(synpro)
in
plant
tissue
is
deep
in
the
plant
matrix,
which
greatly
reduces
availability
for
dermal
or
respiratory
exposure.
Significant
dietary
exposure
to
Cry1Ac
(synpro)
protein
is
unlikely
to
occur.
Dietary
exposures
at
very
low
levels,
via
ingestion
of
processed
commodities,
although,
they
may
occur,
are
unlikely
to
be
problematic
because
of
the
low
toxicity
and
the
high
degree
of
digestibility
of
the
protein.
In
summary
the
potential
for
significant
aggregate
exposure
to
Cry1Ac
(synpro)
protein
is
highly
unlikely.
E.
Cumulative
Exposure
Common
modes
of
toxicity
are
not
relevant
to
consideration
of
the
cumulative
exposure
to
bacillus
thuringiensis
Cry1Ac
(synpro)
insecticidal
crystal
protein.
The
product
has
demonstrated
low
mammalian
toxicity,
and
Bt
insecticidal
crystal
proteins
are
known
to
bind
to
specific
receptors
in
the
insect
gut,
such
that
biological
effects
do
not
appear
to
be
cumulative
with
any
other
known
compounds.
F.
Safety
Determination
1.
U.
S.
population.
The
deployment
of
the
product
in
minute
quantities
within
the
plant,
the
very
low
toxicity
of
the
product,
the
lack
of
allergenic
potential,
and
the
high
degree
of
digestibility
of
the
protein,
are
all
factors
in
support
of
Mycogen's
assertion
that
no
significant
risk
is
posed
by
exposure
of
the
U.
S.
population
to
bacillus
thuringiensis
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62974
Federal
Register
/
Vol.
67,
No.
196
/
Wednesday,
October
9,
2002
/
Notices
*
Session
Closed
Exempt
pursuant
to
5
U.
S.
C.
552b(
c)(
8)
and
(9).
subspecies
kustaki
Cry1Ac
(synpro)
insect
control
protein.
2.
Infants
and
children.
Non
dietary
exposure
to
infants
and
children
is
not
anticipated,
due
to
the
proposed
use
pattern
of
the
product.
Due
to
the
very
low
toxicity
of
the
product,
the
lack
of
allergenic
potential,
and
the
high
degree
of
digestibility
of
the
protein,
dietary
exposure
is
anticipated
to
be
at
very
low
levels
and
is
not
anticipated
to
pose
any
harm
to
infants
and
children.
G.
Effects
on
the
Immune
and
Endocrine
Systems
Given
the
rapid
digestibility
of
Cry1Ac
(synpro)
insecticidal
crystal
protein,
no
chronic
effects
are
expected.
Cry1Ac
(synpro)
insecticidal
crystal
protein,
or
metabolites
of
the
insecticidal
crystal
protein
are
not
known
to,
or
are
expected
to
have
any
effect
on
the
immune,
or
endocrine
systems.
Proteins
in
general
are
not
carcinogenic;
therefore,
no
carcinogenic
risk
is
associated
with
the
Cry1Ac
(synpro)
protein.
H.
Existing
Tolerances
There
are
no
existing
tolerances
or
exemptions
from
tolerance
for
bacillus
thuringiensis
subspecies
kurstaki
Cry1Ac
(synpro)
granted
to
Mycogen
Seeds
c/
o
Dow
AgroSciences
LLC.
[FR
Doc.
02–
25585
Filed
10–
8–
02;
8:
45
am]
BILLING
CODE
6560–
50–
S
FARM
CREDIT
ADMINISTRATION
Sunshine
Act
Meeting;
Farm
Credit
Administration
Board;
Regular
Meeting
AGENCY:
Farm
Credit
Administration.
SUMMARY:
Notice
is
hereby
given,
pursuant
to
the
Government
in
the
Sunshine
Act
(5
U.
S.
C.
552b(
e)(
3)),
of
the
forthcoming
regular
meeting
of
the
Farm
Credit
Administration
Board
(Board).
DATE
AND
TIME:
The
regular
meeting
of
the
Board
will
be
held
at
the
offices
of
the
Farm
Credit
Administration
in
McLean,
Virginia,
on
October
10,
2002,
from
9
a.
m.
until
such
time
as
the
Board
concludes
its
business.
FOR
FURTHER
INFORMATION
CONTACT:
Jeanette
C.
Brinkley,
Acting
Secretary
to
the
Farm
Credit
Administration
Board,
(703)
883–
4009,
TTY
(703)
883–
4056.
ADDRESSES:
Farm
Credit
Administration,
1501
Farm
Credit
Drive,
McLean,
Virginia
22102–
5090.
SUPPLEMENTARY
INFORMATION:
Parts
of
this
meeting
of
the
Board
will
be
open
to
the
public
(limited
space
available),
and
parts
of
this
meeting
will
be
closed.
In
order
to
increase
the
accessibility
to
Board
meetings,
persons
requiring
assistance
should
make
arrangements
in
advance.
The
matters
to
be
considered
at
the
meeting
are:
Open
Session
A.
Approval
of
Minutes
September
12,
2002
(Open)
September
12,
2002
(Open
and
Closed)
September
17,
2002
(Closed)
September
26,
2002
(Open)
B.
Reports
Corporate
Approvals
Provisions
of
the
2002
Farm
Bill
Conditions
and
Trends
in
the
Dallas
Field
Office
Portfolio
C.
New
Business
Regulations
Final
Rule—
Adjusting
Civil
Money
Penalties
for
Inflation
Other
Reaffiliation
of
Northwest
Farm
Credit
Services,
ACA
with
CoBank,
ACB
Merger
of
AgAmerica,
FCB
with
and
into
AgriBank
FCB
East
Carolina
Farm
Credit,
ACA
Restructuring
Consolidation
of
the
Federal
Land
Bank
Association
of
Western
Oklahoma,
FLCA,
Clinton,
PCA,
and
PCA
of
Woodward
to
form
an
ACA
(with
subsidiaries)
Closed*
New
Business
Investments
Securities
Issues
Dated:
October
4,
2002.
Jeanette
C.
Brinkley,
Acting
Secretary,
Farm
Credit
Administration
Board.
[FR
Doc.
02–
25760
Filed
10–
7–
02;
10:
32
am]
BILLING
CODE
6705–
01–
P
FEDERAL
COMMUNICATIONS
COMMISSION
Sunshine
Act
Meeting;
Open
Commission
Meeting,
Thursday,
October
10,
2002
October
3,
2002.
The
Federal
Communications
Commission
will
hold
an
Open
Meeting
on
the
subjects
listed
below
on
,
which
is
scheduled
to
commence
at
in
Room
TW–
C305,
at
445
12th
Street,
SW,
Washington,
DC.
Item
No.
Bureau
Subject
1
..........................................
International
........................
Title:
International
Settlements
Policy
Reform
and
International
Settlement
Rates
(IB
Docket
No.
96–
261).
Summary:
The
Commission
will
consider
a
Notice
of
Proposed
Rulemaking
concerning
the
reform
of
the
International
Settlements
Policy,
its
international
simple
resale
and
benchmarks
policy,
and
the
issue
of
foreign
mobile
termination
rates.
2
..........................................
Media
..................................
Title:
Digital
Audio
Broadcasting
Systems
and
Their
Impact
on
the
Terrestrial
Radio
Broadcast
Service
(MM
Docket
No.
99–
325).
Summary:
The
Commission
will
consider
a
First
Report
and
Order
concerning
digital
operation
by
terrestrial
radio
broadcasters.
3
..........................................
Enforcement
.......................
Title:
SBC
Communications,
Inc.,
Apparent
Liability
for
Forfeiture.
Summary:
The
Commission
will
consider
a
Forfeiture
Order
concerning
compliance
with
the
shared
transport
condition
of
the
SBC/
Ameritech
merger
order.
4
..........................................
Enforcement
.......................
The
Enforcement
Bureau
will
report
to
the
Commission
on
recent
enforcement
activities
Additional
information
concerning
this
meeting
may
be
obtained
from
Maureen
Peratino
or
David
Fiske,
Office
of
Media
Relations,
telephone
number
(202)
418–
0500;
TTY
1–
888–
835–
5322.
Copies
of
materials
adopted
at
this
meeting
can
be
purchased
from
the
FCC's
duplicating
contractor,
Qualex
International
(202)
863–
2893;
Fax
(202)
863–
2898;
TTY
(202)
863–
2897.
These
copies
are
available
in
paper
format
and
alternative
media,
including
large
print/
type;
digital
disk;
and
audio
tape.
Qualex
International
may
be
reached
by
email
at
Qualexint@
aol.
com.
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| epa | 2024-06-07T20:31:43.452345 | regulations | {
"license": "Public Domain",
"url": "https://downloads.regulations.gov/EPA-HQ-OPP-2002-0244-0007/content.txt"
} |
EPA-HQ-OPP-2002-0249-0002 | Supporting & Related Material | "2002-02-11T05:00:00" | null | Page
1
of
30
Overview
of
the
Diruon
Risk
Assessment
July
29,
2002
Introduction
This
document
summarizes
the
Environmental
Protection
Agency's
(
EPA)
human
health,
environmental
fate
and
transport,
and
ecological
risk
findings
for
the
pesticide
diuron,
as
presented
fully
in
the
documents,
"
Diuron:
HED
Risk
Assessment
for
the
Reregistration
Eligibility
Decision
(
RED)
Document,"
dated
March
13,
2002,
and
"
Environmental
Risk
Assessment
for
the
Reregistration
of
Diuron,"
dated
March
11,
2002.
The
purpose
of
this
overview
is
to
help
the
reader
understand
the
conclusions
reached
in
the
risk
assessments
by
identifying
the
key
features
and
findings
of
the
assessments.
References
to
relevant
sections
in
the
complete
documents
are
provided
for
a
more
detailed
explanation.
This
overview
was
developed
in
response
to
comments
from
the
public
which
indicated
that
EPA's
risk
assessments
were
difficult
to
understand,
that
they
were
too
lengthy,
and
that
it
was
not
easy
to
compare
the
assessments
for
different
chemicals
due
to
the
use
of
different
formats.
These
diuron
risk
assessments
and
additional
supporting
documents,
are
posted
on
EPA's
Internet
website
(
http://
www.
epa.
gov/
pesticides/
reregistration/
diuron)
and
are
available
in
the
Pesticide
Docket
for
public
viewing.
Meetings
with
stakeholders
(
i.
e.,
growers,
extension
officials,
public
interest
groups,
commodity
group
representatives
and
other
government
officials)
will
be
held
to
discuss
the
risk
assessments,
the
identified
risks
and
solicit
input
on
risk
mitigation
strategies,
if
needed.
This
feedback
will
be
used
to
complete
the
Reregistration
Eligibility
Decision
(
RED)
document,
which
will
include
the
resulting
risk
management
decisions.
The
Agency
plans
to
conduct
a
close
out
conference
call
with
interested
stakeholders
to
describe
the
regulatory
decisions
presented
in
the
RED.
In
the
case
of
diuron,
the
Agency
intends
to
proceed
with
finalizing
the
tolerance
reassessment
now
and
completing
the
RED,
including
any
necessary
mitigation
for
worker
and
ecological
risks
in
2003.
Risks
summarized
in
this
document
are
those
that
result
only
from
the
use
of
diuron.
The
Food
Quality
Protection
Act
(
FQPA)
requires
that
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."
The
reason
for
consideration
of
other
substances
is
due
to
the
possibility
that
low
level
exposures
to
multiple
chemical
substances
that
cause
a
common
toxic
effect
by
a
common
mechanism
could
lead
to
the
same
adverse
health
effect
as
would
a
higher
level
of
exposure
to
any
of
the
other
substances
individually.
The
Agency
did
not
perform
a
cumulative
risk
assessment
as
part
of
this
reregistration
review
of
diuron
because
the
Agency
has
not
yet
determined
if
there
are
any
other
chemical
substances
that
share
a
common
mechanism
of
toxicity
with
diuron
(
see
Section
6
of
the
Human
Health
Risk
Assessment,
dated
March
13,
2002).
For
purposes
of
this
risk
assessment,
EPA
Page
2
of
30
has
assumed
that
diuron
does
not
have
a
common
mechanism
of
toxicity
with
other
substances.
Available
data
indicate
that
3,4
DCA
is
a
metabolite
of
linuron,
diuron,
and
propanil.
EPA
has
not
aggregated
residues
of
3,4
DCA
for
the
linuron,
diuron
and
propanil
risk
assessments
because
neither
linuron
nor
diuron
metabolize
to
3,4
DCA
in
appreciable
amounts
(
less
than
1%
of
the
parent
compound
for
diuron)
in
animal,
plant
and
environmental
(
soil
and
water)
metabolism
studies.
Therefore,
3,4
DCA
is
a
significant
residue
of
concern
for
propanil,
it
is
not
a
residue
of
concern
per
se
for
linuron
or
diuron.
The
registered
uses
for
linuron,
diuron,
and
propanil
result
in
minimal
cooccurrence
of
use.
That
is,
there
is
very
little
overlap
of
use
patterns
and
the
use
patterns
are
geographically
limited
for
each
active
chemical.
Therefore,
the
risk
assessments
for
each
individual
chemical
fully
assess
the
risks
posed
by
the
parent
compound
and
the
relevant
metabolites.
In
the
future,
the
registrant
may
be
asked
to
submit,
upon
EPA's
request
and
according
to
a
schedule
determined
by
the
Agency,
such
information
as
the
Agency
directs
to
be
submitted
in
order
to
evaluate
issues
related
to
whether
diuron
shares
a
common
mechanism
of
toxicity
with
any
other
substance
and,
if
so,
whether
any
tolerances
for
diuron
need
to
be
modified
or
revoked.
If
the
Agency
identifies
other
substances
that
share
a
common
mechanism
of
toxicity
with
diuron,
we
will
perform
aggregate
exposure
assessments
on
each
chemical,
and
will
begin
to
conduct
a
cumulative
risk
assessment.
The
Agency
has
developed
a
framework
for
conducting
cumulative
risk
assessments
on
substances
that
have
a
common
mechanism
of
toxicity.
This
guidance
was
issued
on
January
16,
2002
(
67
FR
2210
2214),
and
is
available
from
the
OPP
Website
at:
http://
www.
epa.
gov/
pesticides/
trac/
science/
cumulative_
guidance.
pdf.
The
risk
assessment,
and
documents
pertaining
to
the
Agency's
report
on
FQPA
tolerance
reassessment
progress
and
risk
management
decision
for
diuron
are
available
on
the
Internet
at
http://
www.
epa.
gov/
pesticides/
reregistration/
status.
htm
and
the
public
docket
for
viewing.
Because
the
dietary
risks
posed
by
the
use
of
diuron
are
low
and
drinking
water
concerns
are
being
addressed
by
mitigation
and
the
development
of
confirmatory
data,
the
Agency
is
proceeding
with
its
decision
on
the
tolerance
reassessment
at
this
time.
The
Agency's
tolerance
reassessment
decision
for
diuron
will
be
announced
in
the
Federal
Register.
The
complete
RED
for
diuron
will
be
issued
later
this
year.
Use
Profile
°
Herbicide,
Mildewcide
and
Algaecide:
Registered
for
pre
and
post
emergent
herbicide
treatment
of
both
crop
and
non
crop
areas,
as
a
mildewcide
and
preservative
in
paints
and
stains,
and
as
an
algaecide
in
commercial
fish
production,
residential
ponds
and
aquariums.
°
Formulations:
Formulated
as
wettable
powder
(
25%
to
80%
ai),
liquid
(
up
to
40%
ai),
emulsifiable
concentrate
(
2%
to
80%
ai),
dry
flowable
(
40%
to
80
%
ai),
flowable
concentrate
(
19%
to
47.5%
ai),
granular
(
0.2%
to
20%
ai),
pellet/
tablet
(
0.51%
to
19%
ai),
and
ready
to
Page
3
of
30
use
solution
(
0.67%
to
19%
ai).
°
Methods
of
Application:
Applied
by
groundboom
sprayer,
aerial
equipment,
chemigation,
right
of
way
sprayer,
high
and
low
pressure
handwands,
tractor
drawn
spreader,
push
type
spreader,
airless
paint
sprayer,
paintbrush,
paintbrush/
roller,
shaker
type
applicator,
backpack
sprayer,
backpack
granular
spreader,
belly
grinder,
spoon,
or
hand.
°
Use
Rates:
For
agricultural
uses,
labeled
single
application
rates
range
from
0.2
to
9.6
lbs
active
ingredient
(
ai)
per
acre.
One
to
four
applications
per
season
may
be
applied
in
60
day
intervals,
for
most
crops
only
one
application
is
used.
For
non
agricultural
uses
labeled
rates
range
from
0.8
lbs
to
87
lbs
ai/
acre;
however,
the
highest
application
rate
on
an
actively
marketed
label
is
12
lbs
ai/
acre.
The
risk
assessments
evaluate
a
range
of
rates;
however,
this
overview
will
focus
on
application
rates
of
12
lbs
ai/
A
or
lower.
The
higher
rates
on
the
other
products
are
not
being
supported
by
the
registrant
and
will
be
removed
from
product
labels.
Diuron
may
be
applied
to
non
agricultural
areas
1
to
2
times
per
year.
For
the
mildewcide
and
preservative
in
paint
uses,
label
rates
go
up
to
0.053
lbs
ai/
gal.
and
for
algaecidal
uses
labeled
rates
are
less
than
1/
100th
%
ai/
gal.
°
Annual
Poundage:
Estimates
for
total
annual
domestic
use
average
approximately
nine
to
ten
million
pounds
of
active
ingredient.
Approximately
two
thirds
are
used
on
agricultural
crops
and
the
remaining
one
third
on
non
crop
areas.
Diuron
is
used
on
33
crops.
Crops
with
the
highest
percent
crop
treated
are
the
citrus
fruit
group,
dried
citrus
pulp,
blackberries,
blueberries,
boysenberries,
currants,
dewberries,
gooseberries,
huckleberries,
loganberries,
raspberries,
pineapple,
and
asparagus.
In
terms
of
pounds
applied,
oranges
and
cotton
account
for
the
greatest
agricultural
use.
Right
of
way
applications
(
e.
g.,
the
area
around
railroad
tracks)
are
the
greatest
non
agricultural
use
of
diuron,
with
approximately
2
to
3
million
pounds
applied
annually.
°
Registrants:
Griffin
Corporation,
Drexel,
DuPont,
Staveley,
United
Phosphorus,
and
Makhteshim
Agan
of
North
America
Page
4
of
30
Human
Health
Risk
Assessment
Dietary
Diuron
is
an
herbicide
that
is
not
applied
directly
to
most
agricultural
crops,
but
is
applied
to
the
area
around
the
crop
to
kill
weeds.
However,
the
following
crops
can
be
treated
with
foliar
applications
of
diuron:
oats;
forage;
oats,
grain;
oats,
hay;
oats,
straw;
wheat,
forage;
wheat,
grain;
wheat,
hay;
wheat
straw;
birdsfoot
trefoil,
forage;
birdsfoot
trefoil,
hay;
grass,
forage,
except
Bermuda
grass;
grass,
hay,
except
Bermuda
grass;
alfalfa,
forage;
alfalfa,
hay;
asparagus;
clover,
forage;
clover,
hay;
pineapple;
and
sugarcane.
The
residue
data
for
diuron,
which
does
not
indicate
dietary
concerns,
is
consistent
with
this
use
pattern.
Acute
Dietary
Risk
(
Food)
For
a
complete
discussion,
see
section
4.2
of
the
"
Diuron:
HED
Risk
Assessment
for
the
Reregistration
Eligibility
Decision
(
RED)
Document,"
dated
March
13,
2002.
Acute
dietary
risk
is
calculated
considering
foods
eaten
in
one
day
(
consumption)
and
diuron
residue
values
in
or
on
the
food
eaten
by
the
general
population
and
each
population
subgroup
of
interest.
The
consumption
distribution
can
either
be
multiplied
by
a
residue
point
estimate
for
a
deterministic
type
(
i.
e.,
Tier
I/
II)
exposure
assessment,
or
used
with
a
residue
distribution
in
a
Tier
III
probabilistic
type
(
Monte
Carlo)
exposure
assessment.
A
risk
estimate
that
is
less
than
100%
of
the
acute
Population
Adjusted
Dose
(
aPAD)
(
the
dose
at
which
an
individual
could
be
exposed
on
any
given
day
that
would
not
be
expected
to
result
in
adverse
health
effects)
does
not
exceed
the
Agency's
level
of
concern.
The
aPAD
is
the
acute
reference
dose
(
aRFD)
adjusted
for
the
FQPA
safety
factor.
The
Agency
has
not
performed
an
acute
dietary
risk
assessment
of
diuron
because
no
adverse
effects
attributed
to
a
single
exposure
were
identified
in
any
available
study.
Chronic
(
non
cancer)
Dietary
Risk
(
Food)
For
a
complete
discussion,
see
section
4.2
of
the
"
Diuron:
HED
Risk
Assessment
for
the
Reregistration
Eligibility
Decision
(
RED)
Document,"
dated
March
13,
2002.
Chronic
dietary
risk
is
calculated
by
using
an
average
consumption
value
(
based
on
a
survey)
for
food
and
average
residue
values
on
those
foods
consumed
over
a
70
year
lifetime.
A
risk
estimate
that
is
less
than
100%
of
the
chronic
PAD
(
the
dose
at
which
an
individual
could
be
exposed
over
the
course
of
a
lifetime
and
no
adverse
health
effects
would
be
expected)
does
not
exceed
the
Agency's
level
of
concern.
The
cPAD
is
the
chronic
reference
dose
(
cRfD)
adjusted
for
the
FQPA
Safety
Factor.
Page
5
of
30
Chronic
risk
estimates
from
exposures
to
food
do
not
exceed
the
Agency's
level
of
concern.
The
chronic
risk
estimate
for
food
is
about
3%
of
the
cPAD
for
the
U.
S.
Population
and
about
7%
for
children
from
1
6
years,
the
most
sensitive
population
subgroup.
°
The
toxicity
endpoint
for
the
chronic
dietary
assessment
is
from
a
combined
chronic/
carcinogenicity
study
in
rats.
It
is
based
on
evidence
of
hemolytic
anemia
(
an
effect
that
reduces
the
oxygen
carrying
capacity
of
the
blood
cells)
and
compensatory
hematopoiesis
(
regeneration
of
red
blood
cells).
A
No
Observable
Adverse
Effect
Level
(
NOAEL)
was
not
established
and
these
effects
were
observed
at
1.0
mg/
kg/
day
(
Lowest
Observable
Adverse
Effect
Level
or
LOAEL).
°
The
Uncertainty
Factor
(
UF)
is
300X:
10X
for
inter
species
variation,
10X
for
intra
species
extrapolation,
and
3X
for
the
lack
of
a
NOAEL.
°
There
is
an
acceptable
developmental
toxicity
study
in
rabbits
and
an
acceptable
twogeneration
reproduction
study
in
rats.
A
developmental
toxicity
study
in
rats
was
classified
as
unacceptable
due
to
deficiencies
in
analytical
data
on
the
sample
analysis.
However,
the
Hazard
Identification
Assessment
Review
Committee
(
HIARC)
considered
the
developmental
toxicity
study
in
rats
adequate
for
the
FQPA
susceptibility
assessment
based
on
the
observation
that
the
developmental
toxicity
NOAEL
was
higher
than
the
maternal
NOAEL.
°
There
are
no
neurotoxic
signs
in
any
of
the
submitted
subchronic
or
chronic
studies
and
a
literature
search
did
not
reveal
any
studies
relevant
for
assessing
the
potential
neurotoxicity
of
diuron.
°
The
10X
FQPA
Special
Safety
Factor
is
reduced
to
1X
(
i.
e.,
removed)
because
there
is
no
indication
of
increased
susceptibility
of
rats
or
rabbits
to
in
utero
or
postnatal
exposure,
and
the
dietary
and
non
dietary
assessments
are
not
likely
to
underestimate
potential
exposure
to
infants
and
children.
A
developmental
neurotoxicity
study
(
DNT)
with
diuron
is
not
required.
°
The
chronic
Population
Adjusted
Dose
(
cPAD)
is
0.003
mg/
kg/
day
and
is
equal
to
the
LOAEL
(
1.0
mg/
kg/
day)
divided
by
the
uncertainty
factor
(
UF)
of
300X.
°
Anticipated
residues
from
field
trial
data
were
utilized
to
estimate
dietary
exposure.
The
field
trials
were
conducted
at
the
highest
application
rates
allowed
for
the
crop
tested;
therefore,
the
residues
from
these
trials
are
considered
high
end.
Available
processing
data
for
apples,
citrus,
grapes
and
sugarcane
refined
into
sugar
and
molasses
were
used
in
the
assessment.
In
addition,
averaged
percent
crop
treated
information
was
included
in
the
assessment.
°
USDA
Pesticide
Data
Program
(
PDP)
food
monitoring
data
are
available
for
diuron
(
parent
Page
6
of
30
compound)
only.
These
data
indicate
no
detectable
residues
of
the
parent
compound
in
any
of
the
foods
sampled,
PDP
data
were
not
used
in
the
dietary
assessment
because
metabolites
were
not
monitored.
Cancer
Dietary
Risk
(
Food)
For
a
complete
discussion,
see
section
4.2
of
the
"
Diuron:
HED
Risk
Assessment
for
the
Reregistration
Eligibility
Decision
(
RED)
Document,"
dated
March
13,
2002.
Like
chronic
dietary
risk,
potential
dietary
cancer
risk
is
calculated
by
using
the
average
consumption
values
for
food
and
average
residue
values
for
those
foods
over
a
70
year
lifetime.
The
chronic
exposure
value
is
typically
combined
with
a
linear
low
dose
(
Q1*)
approach
to
determine
the
lifetime
(
cancer)
risk
estimate.
The
Agency
generally
considers
risks
lower
than
1
x
10
6
(
i.
e.,
probability
less
than
one
in
one
million)
to
be
of
potential
concern
for
dietary
cancer
exposure.
°
Two
separate
cancer
risk
assessments
were
completed
for
diuron
and
MCPDMU
(
N'(
3
chlorophenyl)
N,
N
dimethyl
urea),
a
degradate
of
diuron
in
water.
Because
the
cancer
effects
(
i.
e.,
target
organs)
for
the
two
compounds
differ,
the
risks
from
diuron
and
MCPDMU
are
not
combined.
°
Diuron
is
classified
as
"
known/
likely
human
carcinogen"
(
See
Carcinogenicity
Peer
Review
of
Diuron,
5/
8/
97).
Carcinogenicity
studies
in
the
rat
showed
urinary
bladder
carcinoma
in
both
sexes
of
Wistar
rat,
and
kidney
carcinomas
in
the
male
rat
(
a
rare
tumor).
Mammary
gland
carcinomas
were
observed
in
the
female
mouse.
°
Based
on
a
Q1*
of
1.91
x
10
2
(
mg/
kg/
day)
1,
the
potential
dietary
cancer
risk
estimate
for
diuron
is
1.68
x
10
6
(
mg/
kg/
day)
1.
°
The
estimated
cancer
dietary
risk
associated
with
the
use
of
diuron
indicates
a
borderline
exceedance
above
1
x
10
6
and
shows
a
lifetime
risk
estimate
of
1.68
x
10
6
for
the
general
population.
The
Agency
does
not
believe
potential
dietary
cancer
risk
to
be
of
concern
because
the
residues
used
in
the
calculations
are
from
field
trials
conducted
at
the
highest
application
rates
and
some
processing
data
are
still
outstanding.
Therefore,
the
exposure
calculation
is
a
conservative
estimate.
°
Information
provided
by
the
registrant
related
to
the
cancer
mechanism
of
action
was
insufficient
to
support
reclassification
of
the
cancer
category
for
diuron
at
this
time.
The
information
suggested
the
reversibility
of
possible
precancerosis
but
did
not
present
or
propose
a
mode
of
action
for
bladder
tumors
from
diuron
exposure.
The
Agency
agrees
that
there
is
little
or
no
concern
for
mutagenic
activity
of
diuron
(
See
the
Agency
HIARC
report,
dated
August
28,
2001).
Page
7
of
30
°
Based
on
a
Q1*
of
a
similar
compound,
monuron,
the
estimated
dietary
risk
for
MCPDMU
is
1.02
x
10
7,
which
includes
catfish
consumption
only.
The
anticipated
residue
of
MCPDMU
in
catfish
was
calculated
using
the
2
ppm
tolerance
for
catfish,
the
fraction
of
applied
radioactive
diuron
converted
to
MCPDMU
in
an
aerobic
aquatic
metabolism
study
(
see
the
Environmental
Risk
Assessment)
and
the
percent
crop
treated
for
catfish.
°
Based
upon
environmental
laboratory
studies,
it
is
known
that
in
drinking
water
only,
diuron
partially
degrades
to
another
chemical
referred
to
as
MCPDMU
(
N'(
3
chlorophenyl)
N,
Ndimethyl
urea).
However,
the
environmental
fate
and
persistence
of
MCPDMU
are
uncertain.
MCPDMU
is
structurally
similar
to
monuron
[
N'(
4
chlorophenyl)
N,
N
dimethyl
urea].
Monuron
produces
tumors
in
the
kidney
and
liver
in
male
rats
and
has
a
Q1*
of
1.52
x
10
2.
Due
to
the
structural
similarity
between
MCPDMU
and
monuron,
the
Agency
believes
it
is
prudent
to
evaluate
the
carcinogenic
risk
associated
with
MCPDMU
based
upon
the
hazard
information
concerning
the
chemical
monuron.
The
Agency
believes
MCPDMU
is
likely
less
toxic
than
monuron,
but
is
unable
to
quantify
this
difference
without
further
information.
The
approach
used
in
this
assessment
yields
a
high
end
estimate.
Absent
information
specifically
about
the
carcinorgenic
potential
of
MCPDMU,
the
Agency
has
taken
this
conservative,
health
protective
approach
in
its
assessment.
The
Agency
is
addressing
this
uncertainty
by
requiring
additional
information
about
the
behavior
and
fate
of
diuron
and
its
drinking
water
degradates.
This
exposure
information
will
permit
refinement
of
the
drinking
water
assessment.
Drinking
Water
Dietary
Risk
For
a
complete
discussion,
see
section
4.3
of
the
"
Diuron:
HED
Risk
Assessment
for
the
Reregistration
Eligibility
Decision
(
RED)
Document,"
dated
March
13,
2002.
Drinking
water
exposure
to
pesticides
can
occur
through
ground
water
and
surface
water
contamination.
EPA
considers
both
acute
(
one
day)
and
chronic
(
lifetime)
drinking
water
risks
and
uses
either
modeling
or
actual
monitoring
data,
if
available,
to
estimate
those
risks.
To
determine
the
maximum
allowable
contribution
of
pesticide
residue
in
water
allowed
in
the
diet,
EPA
first
looks
at
how
much
of
the
overall
allowable
risk
is
contributed
by
food,
then
calculates
a
drinking
water
level
of
comparison
(
DWLOC)
to
determine
whether
modeled
or
monitoring
levels
exceed
this
level.
The
DWLOCs
represent
the
maximum
contribution
to
the
human
diet
(
in
ppb
or
µ
g/
L)
that
may
be
attributed
to
residues
of
a
pesticide
in
drinking
water
after
dietary
exposure
is
subtracted
from
the
aPAD
or
cPAD.
Risks
from
drinking
water
are
assessed
by
comparing
the
DWLOCs
to
the
estimated
environmental
concentrations
(
EECs)
in
surface
water
and
ground
water.
Drinking
water
modeling
is
considered
to
be
an
unrefined
assessment
and
provides
conservative
estimates
based
on
maximum
labeled
rates
and
number
of
applications.
In
this
case,
only
chronic
(
non
cancer)
and
cancer
drinking
water
risks
have
been
assessed
since
no
acute
endpoint
was
identified
and
there
are
no
acute
risks
of
concern.
Page
8
of
30
°
Estimated
drinking
water
concentrations
for
ground
water
are
based
on
the
SCI
GROW
model,
which
is
a
Tier
I
assessment
that
provides
a
conservative
estimate.
The
modeled
estimates
indicate
that
ground
water
concentrations
of
diuron
and
its
metabolites
are
below
the
chronic
DWLOC.
°
For
surface
water,
the
following
Tier
II
screening
models
PRZM
and
EXAMS
were
run
using:
the
maximum
labeled
rates
for
citrus
(
6.4
lb
ai/
A);
the
Index
Reservoir;
and,
the
Percent
Crop
Area
(
PCA)
adjustment
(
to
determine
estimated
surface
water
concentrations
of
diuron
and
its
degradates).
The
drinking
water
assessment
is
based
on
using
the
maximum
rates
on
citrus
crops
in
Florida
because
this
scenario
is
anticipated
to
represent
the
highest
potential
drinking
water
concern.
°
The
index
reservoir
model
represents
a
vulnerable
drinking
water
source
from
a
specific
area
with
specific
cropping
patterns,
weather,
soils,
and
other
factors.
The
PCA
is
a
generic
watershed
based
adjustment
factor
which
represents
the
portion
of
a
watershed
planted
with
a
crop
or
crops.
The
model
indicates
that
diuron
and
its
degradates
have
the
potential
to
contaminate
surface
water
by
runoff
in
areas
with
large
amounts
of
annual
rainfall.
°
Drinking
water
derived
from
surface
water
is
not
of
concern
except
for
chronic
risk
in
the
flatwood
area
of
Florida
at
the
maximum
application
rate.
In
this
area,
the
EECs
at
the
maximum
application
rate
of
6.4
lbs
ai/
A
(
9.6
lbs
ai/
A
per
year)
are
42
ppb,
with
a
DWLOC
of
28
ppb.
The
registrant
for
diuron
has
provided
a
Geographic
Information
System
watershed
analysis
that
may
allow
for
refinement
of
the
modeling
estimates
for
this
area.
Residue
data
to
support
the
9.6
lbs
ai/
A
per
year
rate
are
required.
The
registrant
may
provide
data
to
support
this
use
rate
or
change
the
labels
to
reflect
the
use
rate
of
6.4
lbs
ai/
A
per
year,
as
supported
by
current
residue
data.
°
For
other
areas
of
Florida
where
the
citrus
application
rate
is
3.2
lbs
ai/
A
(
up
to
two
applications
per
year)
the
EECs
are
30
ppb,
with
a
DWLOC
of
28
ppb
for
the
most
sensitive
subpopulation,
children
1
6.
This
represents
a
slight
exceedance
and,
given
the
protective
assumptions
in
the
dietary
assessment,
does
not
pose
a
risk
of
concern.
It
should
be
noted
that
the
original
risk
assessment
used
the
maximum
yearly
rate
for
citrus
(
9.6
lbs
ai/
A)
to
calculate
the
EECs
instead
of
the
maximum
single
application
rate
of
6.4
lbs
ai/
A
for
citrus.
The
information
presented
in
this
overview
is
based
on
the
6.4
lbs
ai/
A
rate.
°
For
diuron
potential
cancer
risk,
no
DWLOC
has
been
calculated.
Food
alone
shows
a
slight
exceedance
for
cancer
risk
(
1.68
x
10
6)
based
on
field
trial
data
using
maximum
application
rates.
These
estimates
can
be
refined
with
additional
processing
data
and
monitoring
data.
To
better
characterize
both
potential
cancer
risks
from
surface
water,
EPA
has
evaluated
monitoring
data
from
Florida,
an
area
of
high
diuron
use.
These
data
indicate
detections
Page
9
of
30
generally
one
to
two
orders
of
magnitude
lower
than
modeled
estimates
for
diuron
(
parent
compound).
The
monitoring
data
for
Florida
can
be
found
on
the
following
website:
www.
sfwmd.
gov/
curre/
pest/
pestindex.
htm.
°
For
the
degradate
MCPDMU,
the
EEC
for
surface
water
using
PRZM/
EXAMS
is
5
ppb,
and
exceeds
the
calculated
DWLOC
of
2.0
ppb,
based
on
the
3.2
lbs
ai/
A
rate
for
citrus.
The
drinking
water
assessment
for
MCPDMU
can
be
refined
with
additional
environmental
fate
data.
These
data
are
required.
°
Additional
monitoring
data
on
diuron
and
its
degradates
evaluated
for
this
assessment
are
listed
below.
A
study
on
the
occurrence
of
cotton
herbicides
and
insecticides
in
the
Playa
Lakes
area
of
the
high
plains
of
western
Texas
was
evaluated.
Diuron
and
metabolites
were
found
in
71%
of
the
samples
collected
from
32
lakes
at
a
mean
concentration
of
2.7
ppb.
This
study
did
not
have
sufficient
frequency
of
sampling
or
a
long
enough
sampling
period
to
be
used
for
regulatory
purposes.
In
addition,
the
study
has
limited
use
in
a
National
assessment
because
western
Texas
is
not
expected
to
be
one
of
the
most
vulnerable
use
areas
for
runoff,
the
method
of
contamination
expected
with
diuron.
However,
because
samples
were
taken
within
2
days
of
application,
the
results
provide
an
indication
of
concentrations
that
could
occur
in
drinking
water
in
that
area.
The
US
Geological
Survey
National
Water
Quality
Assessment
Program
(
NAWQA)
collected
1420
surface
water
samples
from
62
agricultural
stream
sites
during
a
6
year
period
from
1992
1998.
Diuron
was
detected
in
7.32%
of
the
samples
at
a
mean
concentration
of
0.13
ppb.
Residential
Risk
For
a
complete
discussion,
see
section
4.4
of
the
"
Diuron:
HED
Risk
Assessment
for
the
Reregistration
Eligibility
Decision
(
RED)
Document,"
dated
March
13,
2002.
There
are
two
potential
sources
of
exposure
to
diuron
in
a
residential
setting
as
an
algaecide
in
ponds
and
aquariums,
and
as
a
preservative
or
a
mildewcide
in
paints.
Exposure
from
the
dermal
and
inhalation
routes
are
combined
for
each
residential
use.
°
The
algaecide
products
are
formulated
as
tablets/
blocks
and
as
a
liquid.
There
are
no
exposure
data
for
the
use
of
the
algaecide
tablets/
blocks.
Since
the
products
are
formulated
as
tablets/
blocks
and
dissolve
in
less
than
5
minutes,
minimal
exposure
is
expected
and
was
not
quantified.
The
liquid
is
used
at
a
rate
of
one
teaspoon
(
5
ml)
for
every
10
gallons
of
aquarium
or
pond
water,
once
a
month
or
when
algae
growth
reappears.
Residential
exposure
may
Page
10
of
30
result
from
measuring
the
liquid
and
pouring
the
liquid
into
the
aquarium
or
pond.
Exposure
is
expected
to
be
short
term
(
1
to
30
days).
These
risks
are
not
of
concern.
°
Residential
painters
using
paints
and
stains
were
assumed
to
use
airless
sprayers
and
paint
brushes.
Exposure
is
expected
to
be
short
term
(
1
to
30
days).
For
homeowners,
the
airless
sprayer
is
assumed
to
be
used
for
outdoor
applications
only.
For
indoor
applications,
EPA
assumed
that
painting
would
be
restricted
to
small
rooms
such
as
bathrooms
(
high
potential
for
moisture)
where
an
airless
sprayer
is
unlikely
to
be
used.
These
risks
are
not
of
concern.
The
only
potential
residential
exposure
scenario
of
concern
is
due
to
the
cancer
risk
to
applicators
using
diuron
treated
paints
or
stains
applied
with
airless
paint
sprayer
or
paint
brush.
Depending
on
the
exposure
data
used,
application
method
employed
and
the
amount
applied,
calculated
risk
to
applicators
range
from
3
x
10
10
to
3.4
x
10
6
over
a
lifetime
of
70
years.
Similar
to
dietary
cancer
risk,
potential
residential
cancer
risk
is
calculated
by
using
the
average
exposure
over
a
70
year
lifetime.
The
lifetime
exposure
value
is
typically
combined
with
a
linear
low
dose
(
Q1*)
approach
to
determine
the
lifetime
(
cancer)
risk
estimate.
The
Agency
generally
considers
risks
lower
than
1
x
10
6
(
i.
e.,
greater
than
one
in
one
million)
to
exceed
its
level
of
concern
for
potential
residential
cancer
risk.
°
The
applicator
assessment
for
paints
and
stains
applied
with
a
brush
or
an
airless
sprayer
is
based
on
a
Q1*
of
1.91
x
10
2
(
mg/
kg/
day)
1,
and
an
application
rate
of
0.053
lb
ai
per
gallon.
This
is
the
maximum
application
rate.
For
a
cancer
risk
assessment,
typical
rates
would
ordinarily
be
used
but
these
were
not
available.
The
assessment
also
assumes
two
gallons
for
paints
to
five
gallons
for
stains
applied
with
a
brush
per
day
or
fifteen
gallons
applied
per
day
with
an
airless
sprayer,
2
applications
per
year,
50
years
of
use
over
a
70
year
lifetime,
and
a
high
end
dermal
absorption
factor
of
4%
calculated
from
submitted
studies.
Usage
information
gathered
subsequent
to
the
risk
assessment
indicates
that
less
than
5%
of
all
paint
contains
diuron.
Therefore,
it
is
unlikely
that
a
homeowner
would
only
apply
paint
containing
diuron
two
times
per
year
for
50
years.
Postapplication
Risk
Diuron
is
applied
to
ponds/
aquariums
in
the
form
of
a
liquid
or
an
effervescent
tablet.
Due
to
the
high
dilution
rate
of
the
liquid
in
pond
and
aquarium
water
(
0.0000074
lb
ai
per
gallon
of
water),
and
the
effervescent
nature
of
the
tablet
(
expected
to
dissolve
in
less
than
five
minutes),
postapplication
exposure
to
diuron
in
pond
and
aquarium
water
is
expected
to
be
minimal.
Furthermore,
postapplication
activities
in
and
around
ponds/
aquariums
treated
with
diuron
are
assumed
to
be
infrequent.
Postapplication
inhalation
and
dermal
exposure
resulting
from
the
indoor
use
of
diuron
in
paints
is
also
expected
to
be
minimal.
The
Agency
has
conducted
a
screening
level
inhalation
assessment
Page
11
of
30
using
the
Multi
Chamber
Concentration
and
Exposure
Model
(
MCCEM).
The
MCCEM
uses
air
infiltration
and
interzonal
air
flow
rates,
together
with
user
inputs
for
emission
rates,
decay
rates,
and
outdoor
concentrations
to
calculate
time
varying
indoor
concentrations
and
associated
indoor
inhalation
exposure
due
to
product
or
material
emissions
in
several
zones
or
chambers
within
a
residence.
The
result
of
this
model,
coupled
with
diuron's
low
vapor
pressure
(
2
x
10
7
mm
Hg
at
30
E
C),
shows
minimal
postapplication
inhalation
exposure
is
likely.
Furthermore,
diuron
treated
paint
is
most
likely
to
be
used
in
rooms
where
high
humidity
is
expected
(
e.
g.,
a
bathroom),
and
would
rarely
be
used
in
the
entire
house.
It
is
unlikely
that
a
homeowner
would
receive
a
significant
amount
of
postapplication
inhalation
exposure
from
diuron
treated
paint,
as
the
very
nature
of
its
use
is
as
a
mildewcide,
and
any
substantial
loss
of
the
active
ingredient
from
the
paint
would
render
the
product
ineffective.
Aggregate
Risk
For
a
complete
discussion,
see
section
5.0
of
the
"
Diuron:
HED
Risk
Assessment
for
the
Reregistration
Eligibility
Decision
(
RED)
Document,"
dated
March
13,
2002.
The
aggregate
risk
assessment
for
diuron
examines
the
combined
risk
from
exposure
through
food,
drinking
water
and
residential
use.
°
There
are
no
adverse
effects
expected
from
a
single
exposure
to
diuron;
therefore,
an
acute
risk
assessment
was
not
conducted.
Short
term
aggregate
risks
from
food,
residential
inhalation,
and
drinking
water
are
not
of
concern.
°
Estimated
aggregate
chronic
risk
(
noncancer)
concentrations
of
diuron
and
its
metabolites
in
surface
water
slightly
exceed
the
chronic
DWLOC
in
the
Flatwood
area
of
Florida.
Because
field
trial
residue
levels
(
from
maximum
labeled
rates)
were
used
in
the
assessments,
dietary
risks
are
high
end
estimates
and
may
be
refined
further.
°
An
aggregate
cancer
estimate
has
not
been
calculated
since
conservative
assumptions
were
used
in
both
the
dietary
and
drinking
water
assessments.
Thus,
aggregation
of
these
assessments
would
result
in
an
even
more
conservative
expression
of
risk.
°
Dietary
risk
estimates
can
be
further
refined
with
processing
data
and
monitoring
data
that
accounts
for
diuron
and
its
metabolites.
°
Additional
targeted
drinking
water
monitoring
will
be
required
to
fully
characterize
drinking
water
risk
of
diuron
and
its
metabolites.
°
Because
of
the
low
percent
of
paint
containing
diuron,
exposure
to
home
applicators
is
not
likely
to
be
a
significant
contributor
to
aggregate
risk.
°
Calculated
diuron
potential
cancer
risks
from
food
and
residential
applicator
exposure
(
paints
Page
12
of
30
and
stains)
show
a
slight
exceedance
of
the
Agency's
level
of
concern,
1
x
10
6.
As
noted
previously,
both
assessments
include
conservative
exposure
assumptions.
In
both
cases
additional
data
will
allow
for
refinement
of
the
exposure
portion
of
the
assessment.
°
As
discussed
above
(
under
Drinking
Water
Dietary
Risk),
diuron
degrades
in
water
to
MCPDMU.
Because
no
toxicology
data
are
available
for
MCPDMU,
the
Agency
used
data
from
a
structurally
similar
compound,
monuron,
to
assess
the
potential
cancer
risk
from
MCPDMU.
Based
on
the
algaecidal
use
in
commercial
fish
ponds,
the
dietary
cancer
risk
from
catfish
alone
is
1.02
x
10
7
and
is
not
of
concern.
°
For
surface
water
contamination
from
the
degradate
MCPDMU,
crop
and
non
crop
uses
are
potentially
of
concern
based
on
tier
II
modeling
EEC
estimate
of
5
ppb
exceeding
the
DWLOC
of
2.0
ppb,
based
on
a
3.2
lbs
ai/
A
(
up
to
two
applications
per
year).
For
the
Flatwood
area
in
Florida,
where
the
maximum
application
rate
of
6.4
lbs
ai/
A
(
9.6
lbs
ai/
A
per
year)
is
used,
the
EEC
is
8
ppb,
exceeding
the
DWLOC
of
2.0
ppb.
These
estimates
can
be
refined
with
additional
environmental
fate
data
on
the
metabolite
and/
or
monitoring
data.
Residue
data
to
support
the
9.6
lbs
ai/
A
per
year
rate
are
required.
The
registrant
may
provide
data
to
support
this
use
rate
or
change
the
labels
to
reflect
the
use
rate
of
6.4
lbs
ai/
A
per
year,
as
supported
by
current
residue
data.
Occupational
Risk
For
a
complete
discussion,
see
section
7.0
of
the
"
Diuron:
HED
Risk
Assessment
for
the
Reregistration
Eligibility
Decision
(
RED)
Document,"
dated
March
13,
2002.
People
can
be
exposed
to
a
pesticide
while
working
through
mixing,
loading,
or
applying
a
pesticide,
and
reentering
a
treated
site.
Handler
and
worker
risks
(
non
cancer)
are
measured
by
a
Margin
of
Exposure
(
MOE)
which
determines
how
close
the
occupational
exposure
comes
to
a
No
Observed
Adverse
Effect
Level
(
NOAEL)
taken
from
animal
studies.
Generally,
MOEs
greater
than
100
are
not
of
concern.
Potential
cancer
risks
are
measured
in
terms
of
the
increased
chance
that
an
effect
would
occur
over
the
course
of
a
life
time.
In
the
case
of
diuron,
dermal
and
inhalation
risks
for
handlers
are
assessed.
Handler
exposures
to
diuron
are
expected
to
be
short,
intermediate
and
long
term.
However,
no
dermal
endpoints
were
identified
for
short
and
intermediate
term
exposures.
Potential
life
time
cancer
risk
is
also
calculated
for
the
various
handler
scenarios.
The
assessment
also
includes
risks
to
postapplication
workers
who
enter
treated
areas
to
perform
certain
agricultural
activities,
such
as
harvesting.
Occupational
Handler
Summary
Page
13
of
30
EPA
identified
31
handler
exposure
scenarios
resulting
from
mixing/
loading
and
applying
(
liquid
and
dry)
diuron
for
crop
and
non
crop
areas,
based
on
diuron's
labeled
use
directions.
The
assessment
evaluated
mixing,
loading,
and
applying
liquid,
dry
flowable,
wettable
powder,
and
granular
formulations
with
aircraft,
groundboom
sprayer,
chemigation,
high
and
low
pressure
handwands,
tractor
drawn
spreader,
push
type
spreader,
gravity
feed
spreader,
pump
feed
spreader,
and
belly
grinder.
In
addition,
two
scenarios
are
assessed
for
those
mixing
and
loading
diuron
in
the
manufacture
of
paints
and
stains
(
primary
handlers),
two
scenarios
for
commercial
painters
(
secondary
handlers),
and
four
scenarios
for
mixing
and
loading
diuron
algaecides
for
commercial
fish
ponds.
°
Handler
exposures
to
diuron
are
expected
to
be
mainly
of
short
term
duration
(
one
day
to
one
month).
Intermediate
term
exposure
(
one
month
to
several
months)
for
handlers
is
possible
for
large
field
crops,
including
corn,
wheat,
oats
and
cotton,
because
of
their
long
planting
seasons.
Right
of
way
sprayer
scenarios
for
utility
and
industrial
areas
are
assumed
to
be
of
intermediate
term
duration,
because
utility
workers
could
possibly
treat
right
of
way
areas
(
roadsides,
railroads,
etc)
all
summer
long.
However,
for
most
uses
diuron
is
only
applied
one
to
two
times
per
season.
°
Of
the
31
handler
exposure
scenarios,
all
short
and
intermediate
term
exposure
scenarios
resulted
in
MOEs
at
or
near
the
target
of
100
with
PPE
and
engineering
controls,
as
appropriate.
°
No
systemic
toxicity
following
repeated
dermal
dosing
at
1200
mg/
kg/
day
was
seen
in
the
rabbit
dermal
toxicity
study;
therefore,
a
quantitative
non
cancer
dermal
risk
assessment
(
shortand
intermediate
term)
is
not
required.
°
For
the
long
term
dermal
toxicity
endpoint,
a
LOAEL
of
1.0
mg/
kg/
day
is
based
on
evidence
of
hemolytic
anemia
(
an
effect
that
reduces
the
oxygen
carrying
capacity
of
the
blood
cells)
and
compensatory
hematopoiesis
(
regeneration
of
red
blood
cells)
from
the
chronic
toxicity/
carcinogenicity
study
in
the
rat.
Because
a
NOAEL
was
not
established,
an
additional
3x
uncertainty
factor
is
included
resulting
in
a
300x
UF.
°
For
estimating
dermal
risks
in
the
cancer
assessment,
EPA
uses
oral
animal
studies
in
the
absence
of
appropriate
dermal
toxicity
studies
and
adjusts
for
the
amount
of
pesticide
absorbed
through
the
skin.
For
diuron,
no
dermal
absorption
study
is
available.
However,
there
is
a
21
day
dermal
toxicity
study
in
the
rabbit
and
an
oral
developmental
toxicity
study
in
the
rabbit.
An
upper
bound
estimation
of
dermal
absorption
of
4%
was
extrapolated
using
the
maternal
LOAEL
of
50
mg/
kg/
day
from
the
oral
developmental
toxicity
study
in
the
rabbit
and
the
NOAEL
of
1200
mg/
kg/
day
(
HDT)
from
the
21
day
dermal
toxicity
study
in
the
rabbit:
the
ratio
is
50/
1200
or
4%.
Page
14
of
30
°
For
estimating
short,
intermediate,
and
long
term
inhalation
risks,
EPA
uses
oral
animal
studies
in
the
absence
of
appropriate
inhalation
toxicity
studies.
EPA
assumes
100%
of
the
inhaled
diuron
dose
is
absorbed
by
the
body.
°
For
the
short
term
inhalation
toxicity
endpoint,
a
NOAEL
of
10
mg/
kg/
day
is
based
on
decreased
body
weight
and
food
consumption
at
the
maternal
LOAEL
of
50
mg/
kg/
day
from
a
developmental
toxicity
study
in
the
rabbit.
°
For
the
intermediate
term
inhalation
risk
assessment,
a
NOAEL
of
1.0
mg/
kg/
day
is
based
on
altered
hematological
parameters
at
the
LOAEL
of
10
mg/
kg/
day,
observed
at
6
months
in
the
chronic
toxicity/
carcinogenicity
study
in
the
rat.
°
For
the
cancer
assessment,
a
linear
low
dose
approach
is
used
based
a
Q1*
of
1.91
x
10
2
(
mg/
kg/
day)
1
from
carcinogenicity
studies
in
rats
and
mice.
°
No
diuron
specific
exposure
studies
are
available
for
the
occupational
assessment.
Surrogatebased
exposure
assessments
for
each
scenario
are
used
from
the
Pesticide
Handler
Exposure
Database
(
PHED),
the
Outdoor
Residential
Exposure
Task
Force
(
ORETF)
and
other
available
data.
Handler
Risk
Scenarios/
Assumptions
Handler
risk
is
assessed
with
a
variety
of
assumptions
concerning
protection
equipment:
baseline
clothing;
minimum
personal
protective
equipment(
PPE);
maximum
PPE;
and,
when
feasible,
engineering
controls.
Baseline
assessments
assume
long
pants,
long
sleeve
shirt,
shoes,
socks,
and
for
some
scenarios
chemical
resistant
gloves.
Currently,
diuron
handlers
are
required
to
wear
baseline
clothing
with
chemical
resistant
gloves.
Generally,
minimum
PPE
is
baseline
plus
gloves
and
dust
mist
respirator
and
maximum
PPE
adds
coveralls
and
organic
vapor
respirator.
Engineering
controls
typically
include
exposure
reducing
equipment,
such
as
closed
mixing/
loading
systems,
water
soluble
bags,
closed
cabs,
and
closed
cockpits.
The
results
of
the
non
cancer
assessments
for
crop
and
non
crop
areas
indicate
that
all
scenarios
are
at
or
near
the
target
MOE
with
PPE
or
engineering
controls.
The
diuron
cancer
risk
assessment
for
crop
and
non
crop
areas
indicates
five
scenarios
are
of
potential
concern
with
calculated
risks
lower
than
1
x
10
4
even
with
maximum
PPE
or
engineering
controls.
Primary
and
secondary
handler
estimates
to
diuron
in
paints
and
stains,
and
commercial
fish
ponds
are
in
the
10
5
to
10
6
range.
Below
is
a
summary
of
the
handler
risks
of
concern.
The
following
assumptions
and
factors
were
used
when
performing
the
handler(
non
cancer)
risk
assessment:
Page
15
of
30
°
The
average
body
weight
of
70
kg
is
used,
representing
a
typical
adult.
°
Daily
(
8
hour
work
day)
acres
and
volumes
to
be
treated
in
each
scenario
include:
350
acres
for
aerial
applications
to
all
agricultural
crops;
350
acres
for
flaggers
supporting
aerial
applications;
80
acres
for
most
groundboom
crops,
unless
otherwise
specified;
1,000
gallons
for
high
pressure
hand
wands
and
rights
of
way
sprayers;
350
acres
for
chemigation;
40
gallons
for
low
pressure
handwands
and
backpack
sprayers;
80
acres
for
tractor
drawn
spreader;
5
acres
for
a
push
type
spreader
and
backpack
spreader;
1
acre
for
a
belly
grinder;
100
square
feet
for
granular
hand
and
spoon
application;
and
50
gallons
for
airless
sprayer
and
5
gallons
for
paintbrush.
°
The
duration
of
exposure
for
handlers
of
diuron
is
assumed
to
be
mostly
short
term
(
one
day
to
one
month).
Intermediate
term
exposure
(
one
month
to
several
months)
is
possible
for
large
field
crops.
However
most
crops
only
receive
one
application
of
diuron
per
season.
The
following
assumptions
and
factors
were
used
when
performing
the
handler
cancer
risk
assessment:
°
The
average
body
weight
of
70
kg
is
used,
representing
a
typical
adult;
°
Exposure
duration
is
assumed
to
be
35
years.
This
represents
a
typical
working
lifetime;
°
Lifetime
is
assumed
to
be
70
years;
°
Exposure
frequencies
used
in
the
calculations
are,
125
days
per
year
formulating
paints,
30
to
180
days
per
year
for
painters
using
an
airless
sprayer
or
paint
brush;
and
°
The
daily
volumes
used
in
the
calculations
are,
100
to
1,000
gallons
of
paints
treated,
50
gallons
for
painters
using
airless
sprayers,
5
gallons
using
a
paint
brush.
Short
term
Worker
Assessment
for
Crop/
Non
crop
Areas
°
All
mixer/
loader
scenarios
with
wettable
powder
products
are
of
concern
at
baseline;
the
risks
estimated
in
these
scenarios
can
be
mitigated
with
engineering
controls.
°
Loading
and
applying
is
of
concern
with
gravity
feed
equipment
at
high
rate
(
87
lbs
ai/
A)
at
baseline
(
MOE=
36).
This
exposure
is
not
of
concern
at
the
highest
rate
currently
marketed
(
12
lbs
ai/
A).
°
Both
loading
and
applying
granular
products
for
tractor
drawn
spreaders
are
of
concern
with
high
rate
(
87
lbs
ai/
A).
When
using
the
highest
rate
(
12
lbs
ai/
A)
on
a
currently
marketed
label,
this
exposure
is
not
of
concern.
°
All
aerial
application
scenarios
are
not
of
concern
provided
a
closed
cockpit
is
used.
°
Applying
with
high
pressure
handwand
is
of
concern
with
baseline
PPE.
With
maximum
PPE,
Page
16
of
30
the
MOE
is
92.
°
Mixer/
loader/
applicator
risk
is
of
concern
for
low
pressure
handwand
using
baseline
PPE.
With
PPE,
this
risk
is
not
of
concern
(
83
at
min
PPE
and
170
at
max
PPE).
Intermediate
term
Risks
for
Crop/
Non
crop
Areas
°
All
mixer/
loader
scenarios
with
wettable
powders
are
not
of
concern
with
engineering
controls.
°
All
aerial
application
scenarios
are
not
of
concern
provided
a
closed
cockpit
is
used.
°
Mixing/
loading
liquids
is
not
of
concern
with
minimum
PPE.
°
Mixing/
loading
dry
flowable
products
is
of
concern
at
baseline
for
high
acreage
crops
(
1200
A)
with
a
MOE
=
34.
With
minimum
PPE
this
risk
is
not
of
concern.
°
Applying
sprays
for
right
of
ways
with
minimum
PPE,
the
MOE=
93,
but
is
not
of
concern.
Cancer
Risks
for
Crop/
Non
crop
Areas
°
Twenty
six
scenarios
have
cancer
risks
of
concern
between
1
x
10
4
and
1
x
10
6
with
maximum
feasible
PPE/
engineering
controls.
°
At
currently
marketed
rates,
all
risks
are
less
than
1
x
10
4
with
maximum
feasible
PPE/
engineering
controls.
Risks
for
Occupational
Paints
°
Intermediate
term
risk
calculations
for
indoor
painters
using
airless
sprayers
result
in
an
MOE
of
56.
°
Cancer
risk
for
primary
handlers
in
paint
manufacturing
facilities
range
from
7
x10
5
to
2.3
x
10
6.
°
Cancer
risk
for
commercial
painters
using
an
airless
sprayer
range
from
9.5
x
10
5
to
2.2
x
10
5.
°
Cancer
risk
for
commercial
painters
using
a
brush
is
5.8
x
10
5.
Risks
for
Commercial
Fish
Ponds
°
No
risks
of
concern
(
cancer/
non
cancer)
with
use
of
a
closed
mixing
loading
system.
Postapplication
Occupational
Cancer
Risk
EPA
has
determined
that
there
are
potential
cancer
risks
for
both
private
and
commercial
growers
entering
treated
areas
to
perform
certain
agricultural
activities
after
a
diuron
application.
It
should
be
noted
that
a
non
cancer
postapplication
assessment
was
not
conducted
since
no
systemic
toxicity
by
the
dermal
route
is
expected
for
the
short
or
intermediate
term
durations.
°
Only
crops
that
can
receive
direct
foliar
treatments
were
assessed
for
postapplication
risks.
These
crops
are
not
damaged
by
foliar
treatments
of
diuron.
The
crops
assessed
are
oats;
forage;
oats,
grain;
oats,
hay;
oats,
straw;
wheat,
forage;
wheat,
grain;
wheat,
hay;
wheat
straw;
Page
17
of
30
birdsfoot
trefoil,
forage;
birdsfoot
trefoil,
hay;
grass,
forage,
except
Bermuda
grass;
grass,
hay,
except
Bermuda
grass;
alfalfa,
forage;
alfalfa,
hay;
asparagus;
clover,
forage;
clover,
hay;
pineapple;
and
sugarcane.
°
The
postapplication
assessment
is
based
on
the
current
12
hour
restricted
entry
interval.
An
assessment
was
performed
using
both
typical
and
maximum
application
rates.
For
private
growers,
10
days
of
exposure
per
year
is
assumed.
For
commercial
growers,
30
days
of
annual
exposure
is
assumed.
°
For
field
and
row
crops,
medium
exposure
activities,
such
as
moving
irrigation
equipment
and
scouting
mature
plants
are
of
concern
for
cancer
(
private:
1.0
x
10
5;
commercial:
3.0
x
10
5)
at
the
typical
application
rate
and
current
12
hour
restricted
entry
interval
(
REI).
°
For
sugarcane,
medium
exposure
activities,
such
as
scouting
mature
plants
are
potentially
of
concern
for
cancer
(
private:
6.4
x
10
6;
commercial:
1.9
x
10
5)
at
the
typical
application
rate
and
current
12
hour
REI.
°
For
asparagus
and
pineapple,
all
activities
assessed
are
potentially
of
concern
at
typical
application
rates
and
the
12
hour
REI.
The
estimated
risks
for
private
growers
performing
high,
medium,
and
low
exposure
activities
are
1.1
x
10
5,
5.4
x
10
6,
and
3.2
x
10
6,
respectively.
The
estimated
risks
for
commercial
growers
performing
high,
medium,
and
low
exposure
activities
are
3.2
x
10
5,
1.6
x
10
5,
and
9.7
x
10
6,
respectively.
Low
exposure
activities
include
moving
irrigation
pipe,
scouting,
thinning,
and
weeding
immature
plants.
Medium
exposure
activities
include
moving
irrigation
pipe
and
scouting
mature
plants.
High
exposure
activities
include
hand
harvesting
and
pruning.
Ecological
Risk
For
a
complete
discussion,
see
the
"
Environmental
Risk
Assessment
for
the
Reregistration
of
Diuron"
document,
dated
March
11,
2002.
To
estimate
potential
ecological
risk,
EPA
integrates
the
results
of
exposure
and
ecotoxicity
studies
using
the
quotient
method.
Risk
quotients
(
RQs)
are
calculated
by
dividing
exposure
estimates
by
ecotoxicity
values,
both
acute
and
chronic,
for
various
wildlife
species.
RQs
are
then
compared
to
levels
of
concern
(
LOCs).
Generally,
the
higher
the
RQ,
the
greater
the
potential
risk.
Risk
characterization
provides
further
information
on
the
likelihood
of
adverse
effects
occurring
by
considering
the
fate
of
the
chemical
in
the
environment,
communities
and
species
potentially
at
risk,
their
spatial
and
temporal
distributions
and
the
nature
of
the
effects
observed
in
studies.
Environmental
Fate
and
Transport
Page
18
of
30
°
Diuron
is
persistent
and
is
stable
to
hydrolysis.
Calculated
half
lives
in
aqueous
and
soil
photolysis
are
43
and
173
days,
respectively.
Half
lives
in
laboratory
aerobic
and
anaerobic
soil
metabolism
studies
are
372
and
1000
days,
respectively.
However,
in
a
viable
laboratory
aquatic
system,
degradation
occurred
with
half
lives
of
33
and
5
days
in
aerobic
and
anaerobic
systems,
respectively.
In
soil,
the
half
lives
of
diuron
and
its
degradate
DCPMU
range
from
73
to
139
days
and
217
to
1733
days,
respectively.
°
Diuron
has
been
detected
in
ground
and
surface
water
monitoring.
Ground
water
samples
were
taken
from
wells
showing
detections
of
diuron
with
a
mean
concentration
of
2.44
ppb.
Surface
water
samples
were
taken
in
a
study
of
pesticides
in
the
Playa
Lakes
area
of
the
high
plains
of
Texas,
from
32
lakes
with
a
mean
concentration
of
2.7
ppb.
The
United
States
Geological
Survey
(
USGS)
National
Water
Quality
Assessment
Program
(
NAWQA)
program
collected
1420
surface
water
samples
from
62
agricultural
streams
with
an
average
concentration
of
0.13ppb.
Monitoring
data
are
also
available
for
California
and
Florida.
Endangered
Species
The
Endangered
Species
Act
requires
Federal
agencies
to
ensure
that
their
actions
are
not
likely
to
jeopardize
listed
species
or
adversely
modify
designated
critical
habitat.
To
analyze
the
potential
of
registered
pesticide
uses
to
affect
any
particular
species,
EPA
puts
basic
toxicity
and
exposure
data
into
context
for
individual
listed
species
and
their
locations
by
evaluating
important
ecological
parameters,
pesticide
use
information,
the
geographic
relationship
between
specific
pesticides
uses
and
species
locations,
and
biological
requirements
and
behavioral
aspects
of
the
particular
species.
A
determination
that
there
is
a
likelihood
of
potential
impact
to
a
listed
species
may
result
in
limitations
on
use
of
the
pesticide,
other
measures
to
mitigate
any
potential
impact,
or
consultations
with
the
Fish
and
Wildlife
Service
and/
or
the
National
Marine
Fisheries
Service
as
necessary.
For
diuron,
EPA
has
identified
potential
concerns
for
some
endangered
species
in
California
and
Florida.
Terrestrial
and
Aquatic
Organism
Risk
The
impact
to
non
target
terrestrial
and
aquatic
plants
is
the
main
ecological
concern
from
the
use
of
diuron,
which
is
consistent
with
herbicide
use.
Table
1
compares
the
range
of
RQs
for
terrestrial
and
aquatic
organisms
to
the
level
of
concern
for
those
organisms.
Page
19
of
30
Table
1:
Terrestrial
and
Aquatic
Organism
Risk
Quotients
Organism
Crop
Range
of
Application
Rate
(
lbs
ai/
A)
a
Level
of
Concern
Range
of
RQ
Values
Birds
(
acute)
Cotton,
Rights
of
way
1.6
12
0.5
0.01
1.66
Mammals
(
acute)
Rights
of
way
12
0.5
<
0.01
0.55
Mammals
(
chronic)
Cotton,
Citrus
1.2
4.8
1
0.06
9.22
Terrestrial
Plants
(
acute)
Cotton,
Rights
of
way
1.6
12
1
1.25
77
Aquatic
Plants
(
acute)
Cotton,
Rights
of
way
1.6
12
1
9.6
171.7
Freshwater
fish
(
acute)
Cotton,
Rights
of
way
1.2
12
0.5
0.03
0.58
Freshwater
Fish
(
chronic)
Cotton,
Rights
of
way
1.2
12
1
0.50
9
Estuarine
Fish
(
acute)
Cotton,
Sugarcane,
Citrus,
Rights
of
way
1.2
12
0.5
0.01
0.07
Estuarine
Fish
(
chronic)
Cotton,
Rights
of
way
1.2
12
1
0.03
0.53
Freshwater
Invertebrates
(
acute)
Cotton,
Rights
of
way
1.2
12
0.5
0.14
2.58
Freshwater
Invertebrates
(
chronic)
Cotton,
Rights
of
way
1.6
12
1
0.24
1.77
Estuarine
Invertebrates
(
acute)
Cotton,
Rights
of
way
1.2
12
0.5
0.023
0.412
Estuarine
Invertebrates
(
chronic)
Cotton,
Rights
of
way
1.6
12
1
0.17
1.31
a
The
assessment
is
based
on
one
application
per
season
except
for
the
following
uses:
citrus,
2
applications;
cotton,
2
applications;
and
sugarcane,
3
applications.
Page
20
of
30
Incident
Data
There
are
29
ecological
incident
reports
for
nontarget
organisms,
reported
primarily
in
the
1990s.
Of
these
incidents,
one
involved
birds,
16
involved
fish,
and
12
involved
plants.
Of
the
29
incidents,
19
were
associated
with
misuse,
three
were
from
a
registered
use,
and
seven
were
not
identified
as
being
from
a
misuse
nor
a
registered
use.
Tolerance
Reassessment
Summary
For
a
complete
discussion,
see
Residue
Chemistry
Chapter
For
The
Diuron
Reregistration
Eligibility
Decision
(
RED)
Document,
dated
7/
29/
2001.
The
Agency
has
reassessed
all
81
existing
permanent
tolerances
for
diuron
and
can
make
an
FQPA
safety
determination,
provided
that
the
registrant
revises
the
product
labels
consistent
with
the
changes
outlined
in
the
Residue
Chemistry
Chapter
and
submits
the
required
residue
data
to
support
the
9.6
lbs
ai/
A
per
year
rate
for
citrus.
In
addition,
two
new
tolerances
are
proposed
for
use
on
prickly
pear
(
0.05
ppm),
and
spearmint
(
1.5
ppm).
The
Agency
has
sufficient
residue
data
for
reassessing
the
tolerances
for
diuron
and
is
requiring
additional
confirmatory
data
for
alfalfa
forage;
globe
artichokes;
barley
hay;
citrus
(
9.6
lbs
ai/
A
per
year
rate),
cotton
gin
byproducts;
field
corn
aspirated
grain
fractions,
forage
and
stover;
sweet
corn,
stover;
sweet
corn,
forage;
filberts;
grass
forage,
hay
seed
screenings
and
straw;
lemon;
pear;
oat
forage,
hay;
olive;
field
pea
vines
and
hay;
sorghum
aspirated
grain,
fractions,
stover,
and
forage;
and
wheat
forage
and
hay.
For
commodities
that
require
additional
residue
data,
the
current
tolerance
value
will
continue
to
be
used
for
enforcement
purposes
until
new
data
are
received.
If
the
new
data
indicate
that
adjustments
to
tolerances
are
warranted,
adjustments
will
be
made
at
that
time.
Anticipated
residues
for
all
commodities
were
calculated
from
field
trial
data
and
subsequently
utilized
to
estimate
the
dietary
exposure
to
diuron.
Dietary
risks
from
exposure
to
diuron
do
not
exceed
the
Agency's
level
of
concern.
Final
tolerances
for
most
crops
are
being
proposed
as
part
of
this
tolerance
reassessment.
Additional
tolerances
may
be
revised
once
the
confirmatory
field
trial
data
have
been
submitted
to
and
reviewed
by
the
Agency.
In
addition,
processing
data
for
field
corn
and
olives
and
a
metabolism
study
in
fish
are
required.
Table
2:
Tolerance
Reassessment
Summary
for
Diuron
Commodity
Established
Tolerance
(
ppm)
1
Reassessed
Tolerance
(
ppm)
2
Comment
Correct
Commodity
Definition
Tolerances
Listed
Under
40
CFR
§
180.106(
a)
Alfalfa
2
2/(
TBD3)
[
Alfalfa,
forage]
2.0
[
Alfalfa,
hay]
Page
21
of
30
Commodity
Established
Tolerance
(
ppm)
1
Reassessed
Tolerance
(
ppm)
2
Comment
Correct
Commodity
Definition
Apples
1
0.10
The
available
data
indicate
that
the
tolerance
should
be
reduced
to
0.10
ppm.
[
Apple]
Artichokes
1
1/(
TBD)
[
Artichoke,
globe]
Asparagus
7
7.0
Treatment
of
asparagus
is
restricted
to
early
season,
prior
to
the
appearance
of
asparagus
spears.
Bananas
0.1
0.05
This
tolerance
should
be
reclassified
under
180.106(
c),
as
use
of
diuron
on
banana
will
be
restricted
to
HI.
The
available
data
indicate
that
the
tolerance
should
be
reduced
to
0.05
ppm.
[
Banana]
Barley,
grain
1
0.20
These
tolerances
should
be
reclassified
under
180.106(
c),
as
use
of
diuron
on
barley
is
restricted
to
western
OR
and
WA.
The
available
data
indicate
that
the
tolerance
should
be
reduced
to
0.20
ppm
for
barley,
grain;
and
to
1.5
ppm
for
barley,
straw.
Barley,
hay
2
2/(
TBD)
Barley,
straw
(
2)
6
1.5
Birdsfoot
trefoil,
forage
2
0.10
These
tolerances
should
be
reclassified
under
180.106(
c),
as
use
of
diuron
on
trefoil
is
restricted
to
western
OR.
The
available
data
indicate
that
the
tolerance
should
be
reduced
to
0.10
ppm
for
birdsfoot
trefoil,
forage
and
to
0.15
ppm
for
birdsfoot
trefoil,
hay.
Birdsfoot
trefoil,
hay
2
0.15
Blackberries
1
Reassign;
0.10
The
established
tolerances
for
blackberries,
blueberries,
boysenberries,
currants,
dewberries,
gooseberries,
huckleberries,
loganberries,
and
raspberries
should
be
revoked
concomitant
with
the
establishment
of
a
tolerance
for:
The
available
data
indicate
that
these
tolerances
should
be
reduced
to
0.10
ppm.
[
Berry
Group].
Blueberries
1
Boysenberries
1
Currants
1
Dewberries
1
Gooseberries
1
Huckleberries
1
Loganberries
1
Raspberries
1
Cattle,
fat
1
16
Page
22
of
30
Commodity
Established
Tolerance
(
ppm)
1
Reassessed
Tolerance
(
ppm)
2
Comment
Correct
Commodity
Definition
Cattle,
meat
1
16
Cattle,
meat
byproducts
1
16
Citrus
fruits
1
1/(
TBD3,
6)
[
Fruit,
citrus,
group]
Citrus
pulp,
dried
4
4/(
TBD)
[
Citrus,
dried
pulp]
Clover,
forage
2
0.10
These
tolerances
should
be
reclassified
under
180.106(
c),
as
use
of
diuron
on
clover
is
restricted
to
western
OR.
The
available
data
indicate
that
the
tolerance
should
be
reduced
to
0.10
ppm
for
clover,
forage
and
to
1
ppm
for
clover,
hay.
Clover,
hay
2
1
Corn
in
grain
or
ear
form
(
including
sweet
corn,
field
corn,
popcorn)
1
0.10
Concomitant
with
the
reassignment
of
this
tolerance,
a
separate
tolerance
should
be
established
for
[
Corn,
field,
grain].
The
available
data
indicate
that
the
tolerance
should
be
reduced
to
0.10
ppm.
1
0.10
Concomitant
with
the
reassignment
of
this
tolerance,
a
separate
tolerance
should
be
established
for
[
Corn,
pop,
grain].
The
available
data
indicate
that
the
tolerance
should
be
reduced
to
0.10
ppm.
1
0.10
Concomitant
with
the
reassignment
of
this
tolerance,
a
separate
tolerance
should
be
established
for
[
Corn,
sweet,
grain].
The
available
data
indicate
that
the
tolerance
should
be
reduced
to
0.10
ppm.
1
0.10
Concomitant
with
the
reassignment
of
this
tolerance,
a
separate
tolerance
should
be
established
for
[
Corn,
field,
ear].
The
available
data
indicate
that
the
tolerance
should
be
reduced
to
0.10
ppm.
1
0.10
Concomitant
with
the
reassignment
of
this
tolerance,
a
separate
tolerance
should
be
established
for
[
Corn,
pop
ear].
The
available
data
indicate
that
the
tolerance
should
be
reduced
to
0.10
ppm.
Page
23
of
30
Commodity
Established
Tolerance
(
ppm)
1
Reassessed
Tolerance
(
ppm)
2
Comment
Correct
Commodity
Definition
1
0.10
Concomitant
with
the
reassignment
of
this
tolerance,
a
separate
tolerance
should
be
established
for
[
Corn,
sweet
ear].
The
available
data
indicate
that
the
tolerance
should
be
reduced
to
0.10
ppm.
Page
24
of
30
Commodity
Established
Tolerance
(
ppm)
1
Reassessed
Tolerance
(
ppm)
2
Comment
Correct
Commodity
Definition
Corn,
sweet,
fodder
2
Revoke
There
are
no
registered
uses
of
diuron
on
sweet
corn.
Corn,
sweet,
forage
2
Corn,
field
fodder
2
2/(
TBD)
This
tolerance
was
inadvertently
omitted
from
the
1/
14/
98
Final
Rule
technical
amendment
consolidating
40
CFR
parts
185
186
to
40
CFR
part
180.
This
action
will
reinstate
this
tolerance
to
40
CFR
part
180.106.
[
Corn,
field,
stover]
Corn,
pop,
fodder
2
2/(
TBD)
This
tolerance
was
inadvertently
omitted
from
the
1/
14/
98
Final
Rule
technical
amendment
consolidating
40
CFR
parts
185
186
to
40
CFR
part
180.
This
action
will
reinstate
this
tolerance
to
40
CFR
part
180.106.
[
Corn,
pop,
stover]
Corn,
field
forage
2
2/(
TBD)
This
tolerance
was
inadvertently
omitted
from
the
1/
14/
98
Final
Rule
technical
amendment
consolidating
40
CFR
parts
185
186
to
40
CFR
part
180.
This
action
will
reinstate
this
tolerance
to
40
CFR
part
180.106.
[
Corn,
field,
forage]
Corn,
pop,
forage
2
2/(
TBD)
This
tolerance
was
inadvertently
omitted
from
the
1/
14/
98
Final
Rule
technical
amendment
consolidating
40
CFR
parts
185
186
to
40
CFR
part
180.
This
action
will
reinstate
this
tolerance
to
40
CFR
part
180.106.
[
Corn,
pop,
forage]
Cottonseed
1
0.20
The
available
data
indicate
that
the
tolerance
should
be
reduced
to
0.20
ppm.
[
Cotton,
undelinted
seed]
Goats,
fat
1
16
[
Goat,
fat]
Goats,
meat
1
16
[
Goat,
meat]
Goats,
meat
byproducts
1
16
[
Goat,
meat
byproducts]
Grapes
1
0.05
The
available
data
indicate
that
the
tolerance
should
be
reduced
to
0.05
ppm.
[
Grape]
Grass
crops
(
other
than
Bermuda
grass)
2
2/(
TBD)
[
Grass,
forage,
except
Bermuda
grass]
Grass,
hay
(
other
than
Bermuda
grass
hay)
2
2/(
TBD)
[
Grass,
hay,
except
Bermuda
grass]
Hogs,
fat
1
16
[
Hog,
fat]
Page
25
of
30
Commodity
Established
Tolerance
(
ppm)
1
Reassessed
Tolerance
(
ppm)
2
Comment
Correct
Commodity
Definition
Hogs,
meat
1
16
[
Hog,
meat]
Hogs,
meat
byproducts
1
16
[
Hog,
meat
byproducts]
Horses,
fat
1
16
[
Horse,
fat]
Horses,
meat
1
16
[
Horse,
meat]
Horses,
meat
byproducts
1
16
[
Horse,
meat
byproducts]
Nuts
0.1
0.1/(
TBD)
Concomitant
with
the
reassignment
of
this
tolerance,
separate
a
separate
tolerance
should
be
established
for
[
Filbert
].
0.05
Concomitant
with
the
reassignment
of
this
tolerance,
separate
a
separate
tolerance
should
be
established
for
[
Nut,
macadamia].
The
available
data
indicate
that
the
tolerance
should
be
reduced
to
0.05
ppm.
0.05
Concomitant
with
the
reassignment
of
this
tolerance,
separate
a
separate
tolerance
should
be
established
for
[
Pecan].
The
available
data
indicate
that
the
tolerance
should
be
reduced
to
0.05
ppm.
0.05
Concomitant
with
the
reassignment
of
this
tolerance,
separate
a
separate
tolerance
should
be
established
for
[
Walnut].
The
available
data
indicate
that
the
tolerance
should
be
reduced
to
0.05
ppm.
Oats,
forage
2
2/(
TBD)
These
tolerances
should
be
reclassified
under
180.106(
c),
as
use
of
diuron
on
oats
is
restricted
to
ID,
OR,
and
WA.
The
available
data
indicate
that
the
tolerance
should
be
reduced
to
0.10
ppm
for
oats,
grain;
and
to
1.5
ppm
for
oats,
straw.
Oats,
grain
1
0.10
Oats,
hay
2
2/(
TBD)
Oats,
straw
2
1.5
Olives
1
1/(
TBD)
[
Olive]
Papayas
0.5
0.50
[
Papayas]
Peaches
0.1
0.10
[
Peach]
Pears
1
1/(
TBD)
[
Pear]
Peas
1
0.10
The
available
data
indicate
that
the
tolerance
should
be
reduced
to
0.10
ppm.
[
Pea,
field,
seed]
Page
26
of
30
Commodity
Established
Tolerance
(
ppm)
1
Reassessed
Tolerance
(
ppm)
2
Comment
Correct
Commodity
Definition
Peas,
forage
2
2/(
TBD)
[
Pea,
field,
vines]
Peas,
hay
2
2/(
TBD)
[
Pea,
field,
hay]
Peppermint,
hay
2
1.5
The
available
data
indicate
that
the
tolerance
should
be
reduced
to
1.5
ppm.
[
Peppermint,
tops]
Pineapple
1
0.10
The
available
data
indicate
that
the
tolerance
should
be
reduced
to
0.10
ppm.
Potatoes
1
Revoke
There
are
no
registered
uses
of
diuron
on
potatoes.
Rye,
forage
2
Revoke
There
are
no
registered
uses
of
diuron
on
rye.
Rye,
grain
1
Rye,
hay
2
Rye,
straw
2
Sheep,
fat
1
16
Sheep,
meat
1
16
Sheep,
meat
byproducts
1
16
Sorghum,
fodder
2
2/(
TBD)
[
Sorghum,
grain,
stover]
Sorghum,
forage
2
2/(
TBD)
[
Sorghum,
grain,
forage]
Sorghum,
grain
1
0.50
The
available
data
indicate
that
the
tolerance
should
be
reduced
to
0.50
ppm.
[
Sorghum,
grain,
grain]
Sugarcane
1
0.20
The
available
data
indicate
that
the
tolerance
should
be
reduced
to
0.20
ppm.
Vetch,
forage
2
0.10
These
tolerances
should
be
reclassified
under
180.106(
c),
as
use
of
diuron
on
vetch
is
restricted
to
ID,
OR,
and
WA.
The
available
data
indicate
that
these
tolerances
should
be
reduced
to
0.10
ppm
for
vetch,
forage
and
to
1.5
ppm
for
vetch,
hay.
Vetch,
hay
2
1.5
Vetch,
seed
1
Revoke
No
longer
considered
a
significant
livestock
feed
item.
Wheat,
forage
2
2/(
TBD)
Wheat,
grain
1
0.50
The
available
data
indicate
that
the
tolerance
should
be
reduced
to
0.50
ppm.
Wheat,
hay
2
2/(
TBD)
Page
27
of
30
Commodity
Established
Tolerance
(
ppm)
1
Reassessed
Tolerance
(
ppm)
2
Comment
Correct
Commodity
Definition
Wheat,
straw
2
1.5
The
available
data
indicate
that
the
tolerance
should
be
reduced
to
1.5
ppm.
Page
28
of
30
Commodity
Established
Tolerance
(
ppm)
1
Reassessed
Tolerance
(
ppm)
2
Comment
Correct
Commodity
Definition
1.
Expressed
as
diuron
per
se,
unless
otherwise
stated.
2.
To
be
expressed
as
the
combined
residues
of
diuron
and
its
metabolites
convertible
to
3,4
DCA,
expressed
as
diuron.
The
residues
of
3,4
DCA
are
low
but
diuron
residues
are
converted
to
3,4
DCA
for
the
tolerance
expression
based
on
the
assumption
that
the
metabolites
would
not
be
any
more
toxic
than
diuron
and
the
consideration
that
the
analytical
methods
used
to
collect
the
field
trial
data
are
not
capable
of
measuring
each
metabolite
individually.
The
reassessed
tolerances
are
contingent
upon
the
recommended
label
revisions
outlined
in
Table
B
of
the
Residue
Chemistry
Chapter
For
The
Diuron
Reregistration
Eligibility
Decision
(
RED)
Document,
dated
7/
29/
2001.
3.
TBD
=
To
be
determined.
These
commodities
were
included
in
the
dietary
risk
assessment
using
the
Current
Tolerance
level.
Additional
confirmatory
field
trial
residue
data
are
required;
therefore,
the
final
tolerance
may
be
revised.
4.
Expressed
as
combined
residues
of
diuron
and
its
metabolites
convertible
to
3,4
DCA.
5.
Feeding
study
data
have
been
submitted
to
reassess
the
established
tolerances
for
the
fat,
meat,
and
meat
byproducts
of
cattle,
goats,
hogs,
horses,
and
sheep.
Residue
data
are
not
available
for
several
potential
feed
items.
If
the
maximum
dietary
burden
does
not
increase
when
recalculated
from
all
potential
feed
items
after
acceptable
field
trial
data
are
submitted
then
the
established
tolerances
for
residues
in
fat,
meat,
and
meat
byproducts
of
cattle,
goats,
hogs,
horses,
and
sheep
can
be
lowered.
Tolerance
Listed
Under
40
CFR
§
180.106(
b)
Catfish
fillets
2.04
2.0
Expiration
date
of
06/
30/
03
[
Catfish]
Tolerances
To
Be
Proposed
Under
40
CFR
§
180.106(
a)
Aspirated
grain
fractions
N/
A
5.0
Barley,
bran
N/
A
0.7
Citrus,
oil
N/
A
TBD
Cotton,
gin
byproducts
N/
A
TBD
Eggs
N/
A
TBD
Grass,
seed
screenings
N/
A
TBD
Grass,
straw
N/
A
TBD
Milk
N/
A
TBD
Pineapple,
process
residue
N/
A
0.40
Poultry,
meat
byproducts
N/
A
TBD
Prickly
pear
N/
A
0.05
Spearmint
N/
A
1.5
Sugarcane,
molasses
N/
A
0.70
Wheat,
bran
N/
A
0.70
Page
29
of
30
6.
Residue
data
to
support
the
9.6
lbs
ai/
A
per
year
rate
for
citrus
are
required.
The
registrant
may
provide
data
to
support
this
use
rate
or
change
the
labels
to
reflect
the
use
rate
of
6.4
lbs
ai/
A
per
year,
as
supported
by
current
residue
data.
No
maximum
residue
limits
(
MRLs)
for
diuron
have
been
established
by
Codex
for
any
agricultural
commodity.
Summary
of
Pending
Data
The
following
additional
confirmatory
data
have
been
identified.
Toxicology
Data:
°
28
day
inhalation
study
Product
and
Residue
Chemistry
Data:
°
New
confidential
statements
of
formula
reflecting
preliminary
analyses
of
current
products
together
with
discussions
of
formation
of
impurities
°
UV/
Visible
absorption
data/
spectra
°
Independent
lab
validation
for
analytical
method
°
Multiresidue
methods
for
diuron
and
metabolites
in
plants
and
livestock
°
Magnitude
of
residue
field
trial
data
for:
alfalfa
forage;
globe
artichoke;
barley
hay;
citrus
(
at
the
9.6
lbs
ai/
A
rate),
cotton
gin
byproducts;
field
corn
aspirated
grain
fractions,
forage
and
stover;
sweet
corn,
stover;
sweet
corn,
forage;
filbert;
grass
forage,
hay,
seed
screenings,
and
straw;
lemon
(
in
review);
pear;
oat
forage,
hay;
olive;
field
pea
vines
and
hay;
sorghum
aspirated
grain,
fractions,
stover,
and
forage;
and
wheat
forage
and
hay
°
Processing
data
for
field
corn
and
olives
°
Metabolism
study
in
fish
Occupational
Exposure
Data:
°
Exposure
study
of
mixing/
loading/
applying
wettable
powder
or
dry
flowable
with
backpack
sprayer
°
Exposure
study
of
mixing/
loading/
applying
dry
flowable
with
low
pressure
handwand
°
Worker
exposure
resulting
from
contact
with
treated
soil
and
soil
dissipation
study
°
Exposure
study
for
mechanical
harvesting
alfalfa
and
asparagus
Environmental
Fate
and
Ecological
Effects
Data:
°
Avian
reproduction
study
diuron
°
Freshwater
aquatic
invertebrate
life
cycle
toxicity
study
diuron
Page
30
of
30
°
Estuarine/
marine
fish
early
life
cycle
toxicity
study
diuron
°
Nontarget
aquatic
plant
toxicity
study
diuron
°
Upgrade
of
leaching
adsorption
desorption
study
diuron
°
Hydrolysis
of
MCPDMU
°
Aerobic
Soil
Metabolism
of
MCPDMU
°
Aerobic
Aquatic
Metabolism
of
MCPDMU
°
Anaerobic
Aquatic
Metabolism
of
MCPCMU
°
Leaching
Adsorption
Desorption
of
MCPDMU
°
Drinking
water
monitoring
study
on
diuron
and
its
major
degradates
(
reserved).
| epa | 2024-06-07T20:31:43.467446 | regulations | {
"license": "Public Domain",
"url": "https://downloads.regulations.gov/EPA-HQ-OPP-2002-0249-0002/content.txt"
} |
EPA-HQ-OPP-2002-0249-0003 | Supporting & Related Material | "2002-02-11T05:00:00" | null | Page
1
of
4
Diuron
Summary
July
30,
2002
Uses
°
Diuron
is
an
herbicide,
mildewcide
and
algaecide
and
is
used
pre
and
post
emergent
herbicide
treatment
on
a
variety
of
both
crop
and
non
crop
areas;
as
a
mildewcide
in
paints
and
stains,
and
as
an
algaecide
in
commercial
fish
production.
°
On
average,
approximately
nine
to
ten
million
pounds
of
active
ingredient
are
used
annually.
Approximately
two
thirds
are
used
on
agricultural
crops
and
the
remaining
one
third
on
non
crop
areas.
Human
Health
Effects
°
Diuron
has
low
acute
toxicity
by
the
oral,
dermal
or
inhalation
exposure
routes.
Diuron
is
not
an
eye
or
skin
irritant
and
is
not
a
skin
sensitizer.
The
primary
organs
affected
by
chronic
diuron
are
the
hematopoietic
system
(
blood),
the
bladder,
and
renal
pelvis
(
kidney).
Available
data
do
not
reveal
any
developmental
or
reproductive
toxicity.
°
Diuron
is
classified
as
a"
known/
likely"
human
carcinogen
based
on
urinary
bladder
tumors.
°
A
metabolite
of
diuron,
MCPDMU,
has
been
assessed
for
cancer
by
analogy
to
a
structurally
similar
compound,
monuron,
and
represents
worst
case.
It
is
possible
that
MCPDMU
is
less
toxic
than
monuron;
it
is
unlikely
that
it
is
more
toxic.
The
estimated
risk
for
monuron
is
based
on
a
Q*
of
1.52
x
10
2
(
mg/
kg/
day)
1.
Risks
Dietary
Risk
°
Acute
dietary
risks
from
food
treated
with
diuron
are
not
of
concern
because
no
adverse
effects
attributed
to
a
single
exposure
were
identified
in
any
available
study.
°
Chronic
dietary
risks
from
food
treated
with
diuron
are
not
of
concern.
The
chronic
dietary
(
food
only)
risk
estimate
is
3%
of
the
chronic
population
adjusted
dose
(
cPAD)
for
the
U.
S.
population
and
7%
of
the
cPAD
for
children
1
6
years,
the
most
sensitive
subpopulation.
°
Based
on
a
Q*
of
1.91
x
10
2
(
mg/
kg/
day)
1,
the
dietary
cancer
risk
estimate
for
diuron
is
1.68
x
10
6
(
mg/
kg/
day)
1,
slightly
over
the
Agency's
level
of
concern
[
1.0
x
10
6
(
mg/
kg/
day)
1].
°
Dietary
exposure
is
based
on
field
trial
data
adjusted
for
the
percent
of
the
crop
treated
and
processing
data
for
sugarcane
refined
into
sugar
and
molasses.
In
addition,
Page
2
of
4
processing
data
for
apple,
citrus,
and
grapes
were
used
in
the
assessment.
°
Chronic/
cancer
dietary
risk
can
be
further
refined.
°
USDA
Pesticide
Data
Program
monitoring
data
show
no
detectable
residues
of
diuron,
when
monitoring
for
the
parent
compound
only.
Drinking
Water
°
For
diuron,
only
chronic
and
cancer
drinking
water
risks
are
potentially
of
concern
based
on
modeled
estimates.
For
chronic
risk,
only
exposure
from
surface
water
is
of
concern.
°
For
chronic
risk,
the
estimated
environmental
concentrations
(
EECs)
for
surface
water
from
PRZM/
EXAMS
(
42
ppb)
exceeds
the
drinking
water
level
of
comparison
(
DWLOC)
of
28
ppb
for
the
most
sensitive
population
subgroup
(
children
1
6),
in
the
Flatwood
area
of
Florida,
at
the
highest
application
rate.
°
Monitoring
data
from
the
Flatwood
area
of
Florida
show
levels
of
diuron
(
parent
compound
only)
ranging
from
0.2
0.4
µ
g/
L
for
surface
water
and
8.3
120
µ
g/
kg
for
sediment.
°
Residue
data
are
required
to
support
the
9.6
lbs
ai/
A
per
year
application
rate
for
citrus
in
Florida.
Residential
Risk
°
The
only
residential
risk
potentially
of
concern
is
for
cancer
risk
to
applicators
using
diuron
treated
paints
and
stains
applied
with
airless
paint
sprayer
or
paint
brush.
Depending
on
the
exposure
data
used,
application
method
employed,
and
the
amount
applied,
the
calculated
risk
to
applicators
range
from
3
x
10
10
to
3.4x10
6,
assuming
the
average
body
weight
of
the
adult
handler
is
70
kg,
15
gallons
of
diuron
treated
paint
for
an
airless
sprayer,
two
gallons
for
paintbrush
applying
paint
and,
five
gallons
for
paintbrush
applying
stain.
°
The
residential
cancer
risk
assessment
assumes
that
the
average
lifetime
is
70
years
with
an
exposure
duration
of
50
years.
For
paint
exposure,
it
is
assumed
that
the
homeowner
would
only
paint
two
days
per
year.
For
pond
use,
it
is
assumed
that
the
homeowner
would
apply
diuron
once
per
month
or
12
times
a
year.
°
Less
than
5%
of
all
paint
contains
diuron.
Therefore,
it
is
unlikely
that
a
homeowner
would
apply
from
two
to
five
gallons
of
diuron
containing
paint
or
stain
two
times
per
year
for
50
years.
°
Post
application
exposure
to
children
is
expected
to
be
minimal
as
indicated
in
modeled
estimates
of
inhaled
diuron
from
a
screening
level
inhalation
assessment
combined
diuron's
low
vapor
pressure.
Aggregate
Risk
Page
3
of
4
°
The
aggregate
risk
assessment
for
diuron
examines
the
combined
risk
from
exposure
through
food,
drinking
water,
and
residential
use.
°
There
are
no
adverse
effects
expected
from
a
single
exposure
to
diuron;
therefore,
an
acute
risk
assessment
was
not
conducted.
Short
term
aggregate
risks
from
food,
residential
inhalation,
and
drinking
water
are
not
of
concern.
°
Estimated
aggregate
chronic
risk
(
noncancer)
concentrations
of
diuron
and
its
metabolites
in
surface
water
slightly
exceed
the
chronic
DWLOC
in
the
Flatwood
area
of
Florida.
Because
field
trial
residue
levels
(
from
maximum
labeled
rates)
were
used
in
the
assessments,
dietary
risks
are
high
end
estimates
and
may
be
refined
further.
°
An
aggregate
cancer
estimate
has
not
been
calculated
since
conservative
assumptions
were
used
in
both
the
dietary
and
drinking
water
assessments.
Thus,
aggregation
of
these
assessments
would
result
in
an
even
more
conservative
expression
of
risk.
°
Dietary
risk
estimates
can
be
further
refined
with
processing
data
and
monitoring
data
that
accounts
for
diuron
and
its
metabolites.
°
Additional
targeted
drinking
water
monitoring
will
be
required
to
fully
characterize
drinking
water
risk
of
diuron
and
its
metabolites.
°
Because
of
the
low
percent
of
paint
containing
diuron,
exposure
to
home
applicators
is
not
likely
to
be
a
significant
contributor
to
aggregate
risk.
Occupational
Risks
°
The
Agency
has
identified
31
handler
scenarios
resulting
from
mixing/
loading
and
applying
diuron
for
crop
and
non
crop
uses.
Of
the
31
scenarios,
all
short
and
intermediate
term
exposures
resulted
in
a
Margin
of
Exposure
(
MOE)
at
or
near
the
target
of
100
with
personal
protective
equipment
(
PPE)
and
engineering
controls
(
e.
g.,
closed
mixing
and
loading
systems),
as
appropriate.
°
For
the
cancer
assessment,
the
following
scenarios
are
potentially
of
concern:
applying
with
a
right
of
way
sprayer;
applying
in
an
industrial/
commercial
setting
with
a
highpressure
handwand;
mixing/
loading/
applying
wettable
powder
products
with
a
lowpressure
handwand;
loading
and
applying
with
a
gravity
feed
backpack
spreader;
and
loading
and
applying
with
a
belly
grinder.
°
For
the
occupational
paint
assessment,
the
following
scenarios
are
potentially
of
concern:
painters
using
airless
sprayers;
cancer
risk
for
primary
handlers
in
paint
manufacturing
facilities;
cancer
risk
for
commercial
painters
using
an
airless
sprayer;
and
cancer
risk
for
painters
using
a
brush.
°
For
commercial
catfish
ponds,
cancer
is
not
a
concern
if
closed
mixing
and
loading
systems
are
used.
Post
Application
Risks
°
Only
the
crops
that
can
receive
foliar
applications
(
oats,
wheat,
birdsfoot
trefoil,
grass
Page
4
of
4
grown
for
seed,
alfalfa,
asparagus,
pineapple,
and
sugarcane)
are
assessed
for
post
application
risks.
°
For
field
and
row
crops
and
sugarcane,
medium
exposure
activities
such
as
moving
irrigation
equipment
and
scouting
mature
plants
are
potentially
of
concern
for
cancer
at
the
typical
application
rate
and
current
12
hour
restricted
entry
interval
(
REI).
°
For
asparagus
and
pineapple,
all
activities
assessed
are
potentially
of
concern
at
typical
application
rates.
Environmental
Fate
and
Effects
Risks
Avian
°
Diuron
is
slightly
toxic
to
bobwhite
quail
and
practically
non
toxic
to
the
mallard
duck
on
an
acute
oral
basis.
It
is
practically
non
toxic
to
bobwhite
quail
and
slightly
toxic
to
mallard
duck
on
a
subacute
dietary
basis.
°
The
risk
quotients
(
RQs)
for
avian
species
range
from
0.01
1.66.
Aquatic
Species
°
Diuron
is
moderately
toxic
to
the
majority
of
aquatic
animals
tested
(
including
rainbow
trout,
bluegill
sunfish,
water
flea,
striped
mullet,
sheepshead
minnow,
Eastern
oyster,
and
brown
shrimp).
°
Diuron
is
highly
toxic
to
cutthroat
trout
and
scuds
and
slightly
toxic
to
fathead
minnow.
°
The
RQs
for
aquatic
species
range
from
0.01
9.
°
The
Agency
has
asked
the
registrant
to
submit
data
on
the
environmental
fate
of
diuron
and
its
degradate
MCPDMU.
Mammalian
°
There
is
potential
chronic
risk
to
small
mammals
feeding
on
short
grass
or
broad
leaf
plants.
°
The
RQs
for
mammalian
species
range
from
<
0.01
9.22.
Non
target
Plants
°
There
are
risks
to
non
target
terrestrial
and
aquatic
plants.
°
The
RQs
for
non
target
plant
species
range
from
1.25
172.
| epa | 2024-06-07T20:31:43.484698 | regulations | {
"license": "Public Domain",
"url": "https://downloads.regulations.gov/EPA-HQ-OPP-2002-0249-0003/content.txt"
} |
EPA-HQ-OPP-2002-0249-0004 | Supporting & Related Material | "2002-02-11T05:00:00" | null | UNITED
STATES
ENVIRONMENTAL
PROTECTION
AGENCY
WASHINGTON,
D.
C.
20460
OFFICE
OF
PREVENTION,
PESTICIDES
AND
TOXIC
SUBSTANCES
July
30,
2002
CERTIFIED
MAIL
Ronald
Landis,
Ph.
D.
Landis
International
3185
Madison
Highway
PO
Box
5126
Valdosta,
GA
31603
5126
Dear
Dr.
Landis:
Background
This
is
the
Environmental
Protection
Agency's
(
hereafter
referred
to
as
EPA
or
the
Agency)
"
Report
of
the
Food
Quality
Protection
Act
(
FQPA)
Tolerance
Reassessment
Progress
and
Risk
Management
Decision
(
TRED)
for
Diuron"
which
was
approved
on
July
30,
2002.
A
Notice
of
Availability
of
this
tolerance
reassessment
decision
will
be
published
in
the
Federal
Register
(
FR)
shortly.
The
Federal
Food,
Drug
and
Cosmetic
Act
(
FFDCA),
as
amended
by
FQPA,
requires
EPA
to
reassess
all
the
tolerances
for
registered
chemicals
in
effect
on
or
before
the
date
of
the
enactment
of
the
FQPA,
which
was
in
August
of
1996.
The
Agency
is
required
by
FQPA
to
have
2/
3
(
approximately
6,416)
of
all
tolerances
reassessed
prior
to
August
5,
2002.
In
order
to
meet
the
FQPA
tolerance
reassessment
goal,
the
tolerance
portion
of
the
reregistration
will
be
completed
prior
to
the
issuance
of
the
Reregistration
Eligibility
Decision
(
RED).
A
RED
for
diuron
will
be
completed
in
2003,
which
will
address
any
occupational
or
ecological
risk
concerns.
In
reassessing
these
tolerances,
the
Agency
must
consider,
among
other
things,
aggregate
risks
from
non
occupational
sources
of
pesticide
exposure,
whether
there
is
increased
susceptibility
to
infants
and
children,
and
the
cumulative
effects
of
pesticides
with
a
common
mechanism
of
toxicity.
Once
a
safety
finding
has
been
made
that
aggregate
risks
are
not
of
concern,
the
tolerances
are
considered
reassessed.
Diuron
Assessment
For
diuron,
acute
and
chronic
(
non
cancer)
dietary
food
risks
are
not
of
concern.
Drinking
water
derived
from
ground
water
is
not
a
concern
for
any
duration
or
sub
population.
Drinking
water
derived
from
surface
water
is
not
of
concern
except
for
the
estimated
chronic
risk
in
the
flatwood
area
of
Florida
at
the
maximum
application
rate.
For
other
areas
of
Florida
where
the
citrus
application
rate
is
3.2
lbs
ai/
A
(
up
to
two
applications
per
year)
the
estimated
environmental
concentration
(
EECs)
are
30
ppb,
with
2
a
drinking
water
level
of
comparison
(
DWLOC)
of
28
ppb
for
the
most
sensitive
subpopulation,
children
1
6.
This
represents
a
slight
exceedance
and,
given
the
protective
assumptions
in
the
dietary
assessment,
does
not
pose
a
risk
of
concern.
EPA's
risk
assessment
identified
some
areas
of
potential
concern.
These
include:
chronic
surface
drinking
water
risk
for
the
flatwood
area
of
Florida;
a
slight
exceedance
for
cancer
risk
from
food;
potential
cancer
risk
of
MCPDMU
(
N'(
3
chlorophenyl)
N,
N
dimethyl
urea)
in
water;
residential
applicator
risk
from
paint
or
stain
use;
and
aggregate
risk.
FQPA
Finding
Although
some
risks
potentially
of
concern
have
been
identified,
EPA
is
able
to
make
a
determination
of
reasonable
certainty
of
no
harm
for
diuron,
based
on
further
characterization
of
these
risks,
the
registrant's
commitment
to
mitigation
measures
designed
to
reduce
exposure
to
diuron
and
its
metabolites
in
drinking
water,
and
the
development
of
data
to
confirm
that
the
mitigation
measures
are
adequate.
Each
risk
of
potential
concern,
related
to
the
tolerance
reassessment,
with
its
characterization
and
the
mitigation
designed
to
address
the
concern,
is
discussed
below.
It
should
be
noted
that
when
the
Agency
evaluates
the
ecological
and
worker
risks
during
the
development
of
the
RED,
additional
risk
mitigation
may
be
necessary.
Cancer
Risk
from
Food
°
The
estimated
cancer
dietary
risk
associated
with
the
use
of
diuron
indicates
a
borderline
exceedance
above
1
x
10
6
and
shows
a
lifetime
risk
estimate
of
1.68
x
10
6
for
the
general
population
but,
is
not
of
concern.
°
The
residues
used
in
the
calculations
are
from
field
trials
conducted
at
the
highest
application
rates
and
some
processing
data
are
still
outstanding,
which
will
allow
further
refinement
of
the
risk
assessment
and
likely
lower
the
risk
estimates.
°
USDA
Pesticide
Data
Program
(
PDP)
monitoring
data
are
available
for
diuron
alone,
indicating
no
detectable
residues
of
the
parent
compound
in
citrus,
milk
and
other
sampled
commodities.
°
Conservative
assumptions
were
used
in
risk
assessment;
therefore,
the
exposure
calculation
for
cancer
dietary
risk
is
a
conservative
estimate.
Chronic
Drinking
Water
Risk
from
Surface
Water
°
Potential
chronic
drinking
water
risk
concerns
from
surface
water
are
limited
to
high
use
rate
areas
located
in
the
southern
Florida
flatwood.
In
this
area,
the
EECs
at
the
maximum
application
rate
of
6.4
lbs
ai/
A
(
9.6
lbs
ai/
A
per
year)
are
42
ppb,
with
a
DWLOC
of
28ppb.
Residue
data
to
support
the
9.6
lbs
ai/
A
per
year
rate
are
required.
The
registrant
may
provide
data
to
support
this
use
rate
or
change
the
labels
to
reflect
the
use
rate
of
6.4
lbs
ai/
A
per
year,
as
supported
by
current
residue
data.
3
°
The
registrant
is
developing
additional
information
to
refine
the
conservative
percent
crop
area
(
PCA)
factor
(
87%)
used
in
the
drinking
water
assessment.
This
research
will
include
spatial
integration
of
information
on
surface
water
sources
for
drinking
water
in
the
high
use
rate
areas
relative
to
citrus
production
and
soil
runoff
potential.
°
Existing
surface
water
monitoring
data
for
diuron
from
Florida
and
California
show
a
relatively
high
percentage
of
detections,
but
concentrations
generally
one
to
two
orders
of
magnitude
less
than
modeled
values.
°
The
registrants
have
agreed
to
rate
reductions,
reductions
in
the
number
of
applications
per
year,
and
increases
in
the
intervals
between
applications
as
outlined
in
Table
1.
°
Additional
targeted
drinking
water
monitoring
will
be
required
to
fully
characterize
drinking
water
risk
of
diuron
and
its
metabolites.
Potential
Cancer
Risk
of
the
MCPDMU
Metabolite
in
Water
°
In
water
only,
diuron
partially
degrades
to
another
chemical,
MCPDMU
(
N'(
3
chlorophenyl)
N,
N
dimethyl
urea).
°
The
cancer
estimate
for
MCPDMU
is
derived
by
analogy
to
a
similar
compound,
monuron,
and
represents
worst
case.
It
is
possible
that
MCPDMU
is
less
toxic
than
monuron;
it
is
unlikely
that
it
is
more
toxic.
Monuron
produces
kidney
and
liver
tumors
in
male
rats.
The
estimated
risk
for
monuron
is
based
on
a
Q*
of
1.52
x
10
2
(
mg/
kg/
day)
1.
°
Since
there
is
potential
for
MCPDMU
to
occur
in
water,
the
Agency
considered
possible
exposures
to
MCPDMU
from
ingestion
of
catfish,
as
well
as
from
drinking
water.
°
For
chronic
risk,
the
EECs
for
surface
water
from
PRZM/
EXAMS
(
42
ppb)
exceeds
the
drinking
water
level
of
comparison
(
DWLOC)
of
28
ppb
for
the
most
sensitive
population
subgroup
(
children
1
6),
in
the
Flatwood
area
of
Florida,
at
the
highest
application
rate.
°
Residue
data
to
support
the
9.6
lbs
ai/
A
per
year
rate
for
citrus
are
required.
The
registrant
may
provide
data
to
support
this
use
rate
or
change
the
labels
to
reflect
the
use
rate
of
6.4
lbs
ai/
A
per
year,
as
supported
by
current
residue
data.
°
Additional
data
are
being
required
about
the
behavior
and
fate
of
MCPDMU
in
drinking
water.
This
information
will
permit
refinement
of
the
drinking
water
assessment.
°
The
reductions
in
application
rate
and
the
number
of
applications
per
year
shown
in
Table
1
will
also
reduce
exposure
to
diuron
metabolites.
°
If
the
refined
data
and
refined
assessment
still
show
drinking
water
concerns,
drinking
water
monitoring
and/
or
toxicity
data
on
MCPDMU
will
be
required.
4
5
Residential
Cancer
Risk
from
Paint
or
Stain
Use
°
Calculated
cancer
risk
to
adult
applicators
using
diuron
treated
paints
or
stains
applied
with
airless
paint
sprayer
or
paint
brush
is
estimated
to
range
from
9.5
x
10
7
to
3.4
x
10
6,
depending
on
the
exposure
assumptions
used,
application
method
employed
and
the
amount
applied.
°
Post
application
exposure
to
children
is
expected
to
be
minimal
as
indicated
in
modeled
estimates
of
inhaled
diuron
from
a
screening
level
inhalation
assessment
combined
diuron's
low
vapor
pressure.
°
The
assessment
assumes
two
gallons
for
paints
to
five
gallons
for
stains
applied
with
a
brush
per
day
or
fifteen
gallons
applied
per
day
with
an
airless
sprayer,
2
applications
per
year,
50
years
of
use
over
a
70
year
lifetime,
and
a
high
end
dermal
absorption
factor
of
4%
calculated
from
submitted
studies.
°
Less
than
5%
of
all
paint
contains
diuron.
Therefore,
it
is
unlikely
that
a
homeowner
would
apply
2
to
5
gallons
of
paint
containing
diuron
two
times
per
year
for
50
years.
Aggregate
Risk
The
aggregate
risk
assessment
for
diuron
examines
the
combined
risk
from
exposure
through
food,
drinking
water,
and
residential
use.
°
There
are
no
adverse
effects
expected
from
a
single
exposure
to
diuron;
therefore,
an
acute
risk
assessment
was
not
conducted.
Short
term
aggregate
risks
from
food,
residential
inhalation,
and
drinking
water
are
not
of
concern.
°
Estimated
aggregate
chronic
risk
(
noncancer)
concentrations
of
diuron
and
its
metabolites
in
surface
water
slightly
exceed
the
chronic
DWLOC
in
the
Flatwood
area
of
Florida.
Because
field
trial
residue
levels
(
from
maximum
labeled
rates)
were
used
in
the
assessments,
dietary
risks
are
high
end
estimates
and
may
be
refined
further.
°
An
aggregate
cancer
estimate
has
not
been
calculated
since
conservative
assumptions
were
used
in
both
the
dietary
and
drinking
water
assessments.
Thus,
aggregation
of
these
assessments
would
result
in
an
even
more
conservative
expression
of
risk.
°
Dietary
risk
estimates
can
be
further
refined
with
processing
data
and
monitoring
data
that
accounts
for
diuron
and
its
metabolites.
°
Additional
targeted
drinking
water
monitoring
will
be
required
to
fully
characterize
drinking
water
risk
of
diuron
and
its
metabolites.
°
Because
of
the
low
percent
of
paint
containing
diuron,
exposure
to
home
applicators
is
not
likely
to
be
a
significant
contributor
to
aggregate
risk.
6
7
Mitigation
and
Best
Management
Practices
The
registrant
has
agreed
to
the
following
measures
to
reduce
exposure
to
diuron:
°
Best
Management
Practices
for
managing
spray
drift.
°
No
aerial
applications
except
for
rights
of
way,
alfalfa,
and
cotton.
°
Eliminate
use
in
areas
with
muck
soils.
°
Rate
reductions,
increased
application
intervals,
and
limits
on
the
number
of
application
as
noted
below
in
Table
1.
°
Revise
the
product
labels
consistent
with
the
changes
outlined
in
the
Residue
Chemistry
Chapter
and
submits
the
required
residue
data
to
support
the
9.6
lbs
ai/
A
per
year
rate
for
citrus.
8
Table
1:
Revised
Application
Parameters
Crop
Current
Maximum
Application
Rate
Current
Number
of
Applications/
Retreatment
Interval
Revised
Maximum
Application
Rate
Revised
Number
of
Applications/
Retreatment
Interval
Right
of
Way
12
lb
ai/
A
(
typically
18
lb
ai/
A
year)
Not
Restricted
(
Typically
2)
12
lb
ai/
A
per
year
2
,
with
a
90
day
retreatment
interval
Citrus
(
other
than
Flatwood
area)
3.2
lb
ai/
A
No
Limit
(
1.6
3.2
lb/
A
per
application
to
max
of
6.4
lb/
A
per
year)
3.2
lb
ai/
A
(
6.4
lb
ai/
A
per
year)
2
,
with
a
60
day
retreatment
interval
(
Trees
<
4
years)
2
,
with
a
80
day
retreatment
interval
(
Trees
>
4
years)
Citrus
(
Flatwood
area)*
6.4
lb
ai/
A
(
9.6
lb
ai/
A
per
year)
No
Limit
(
1.6
6.4
lb/
A
per
application
to
max
of
9.6
lb/
A
per
year)
6.4
lb
ai/
A
(
9.6
lb
ai/
A
per
year)
2
,
with
a
60
day
retreatment
interval
(
Trees
<
4
years)
2
,
with
a
80
day
retreatment
interval
(
Trees
>
4
years)
Apple
3.2
lb
ai/
A
1
2
(
1.6
3.2
lb/
A
to
max
of
3.2
lb/
A
per
year)
3.2
lb
ai/
A
per
year
1
2
(
1.6
3.2
lb/
A
to
max
of
3.2
lb
ai/
A
per
year),
with
a
90
day
retreatment
interval
Alfalfa
3.2
lb
ai/
A
1
app./
year
2.4
lb
ai/
A
per
year
1
Cotton
2.2
lb
ai/
A
Not
Restricted
Preplant/
Pre
emergence:
(
0.8
1.6
lb
ai/
A)
3,
with
total
ai
per
season
limited
to
0.8
lb
ai/
A
on
coarse
soils,
1.5
lb
ai/
A
on
medium
soils
and
2.2
lb
ai/
A
on
fine
soils,
with
a
21
day
retreatment
interval
Post
emergence:
(
0.8
1.2
lb
ai/
A,
depending
upon
soil
texture)
Grapes
9.6
lb
ai/
A
2
4
lb
ai/
A
(
8
lb
ai/
A
per
year)
2,
with
a
90
day
retreatment
interval
*
Residue
data
to
support
the
9.6
lbs
ai/
A
per
year
rate
is
required,
or
labels
modified
to
reflect
a
maximum
of
6.4
lbs
ai/
A
applied
per
year.
9
Cumulative
Assessment
FQPA
requires
that
EPA
consider
"
available
information"
concerning
the
cumulative
effects
of
a
particular
pesticide's
residues
and
"
other
substances
that
have
a
common
mechanism
of
toxicity."
The
reason
for
considering
other
substances
is
because
of
the
possibility
that
low
level
exposures
to
multiple
chemical
substances
that
cause
a
common
toxic
effect
by
a
common
mechanism
could
lead
to
the
same
adverse
health
effect,
as
would
a
higher
level
of
exposure
to
any
of
the
other
substances
individually.
EPA
did
not
perform
a
cumulative
risk
assessment
as
part
of
this
review
of
diuron,
because
the
Agency
has
not
determined
that
there
are
any
other
chemical
substances
that
have
a
mechanism
of
toxicity
common
with
that
of
diuron.
If
EPA
identifies
other
substances
that
share
a
common
mechanism
of
toxicity
with
diuron,
then
a
cumulative
risk
assessment
will
be
conducted
that
includes
diuron
once
the
final
framework
EPA
will
use
for
conducting
cumulative
risk
assessments
is
available.
Further,
EPA
is
in
the
process
of
developing
criteria
for
characterizing
and
testing
endocrine
disrupting
chemicals
and
plans
to
implement
an
Endocrine
Disruptor
Screening
Program.
Diuron
will
be
reevaluated
at
that
time
and
additional
studies
may
be
required.
Tolerance
Reassessment
The
Agency's
tolerance
reassessment
for
the
pesticide
diuron,
has
been
discussed
with
interested
stakeholders
and
a
closure
call
will
be
held
prior
to
issuance
of
the
RED.
In
addition,
both
the
human
health
effects
and
the
environmental
risk
assessments
are
summarized
in
the
enclosed
Overview
of
the
Diuron
Risk
Assessment
document.
The
risk
assessments
and
other
documents
pertaining
to
the
diuron
tolerance
reassessment
decision
are
available
on
the
Internet
at
http://
www.
epa.
gov/
pesticides/
reregistration/
status.
htm
and
are
in
the
public
docket
for
viewing.
As
mentioned
previously,
other
risks
posed
by
diuron
will
be
addressed
through
the
reregistration
process
in
2003.
The
Agency
has
reassessed
all
81
existing,
permanent
tolerances
for
diuron
and
can
make
a
FQPA
safety
determination.
In
addition,
two
new
tolerances
are
proposed
for
use
on
prickly
pear
(
0.05
ppm),
and
spearmint
(
1.5
ppm).
The
Agency
has
sufficient
residue
data
for
reassessing
the
tolerances
for
diuron
and
is
requiring
additional
confirmatory
data
for
alfalfa
forage;
globe
artichokes;
barley
hay;
citrus
(
9.6
lbs
ai/
A
per
year
rate),
cotton
gin
byproducts;
field
corn
aspirated
grain
fractions,
forage
and
stover;
sweet
corn,
stover;
sweet
corn,
forage;
filberts;
grass
forage,
hay
seed
screenings
and
straw;
lemon;
pear;
oat
forage,
hay;
olive;
field
pea
vines
and
hay;
sorghum
aspirated
grain,
fractions,
stover,
and
forage;
and
wheat
forage
and
hay.
For
commodities
that
require
additional
residue
data,
the
current
tolerance
value
is
protective
of
human
health
and
will
continue
to
be
used
for
enforcement
purposes
until
new
data
are
received.
If
the
new
data
indicate
that
adjustments
to
tolerances
are
warranted,
they
will
be
adjusted
at
that
time.
Anticipated
residues
for
all
commodities
were
calculated
from
field
trial
data
and
subsequently
utilized
to
estimate
the
dietary
exposure
to
diuron.
Dietary
risks
from
exposure
do
not
exceed
the
Agency's
level
of
concern.
Final
tolerances
for
most
crops
are
being
proposed
as
part
of
this
tolerance
reassessment.
Additional
tolerances
may
be
revised
once
the
confirmatory
field
trial
data
have
been
submitted
to
and
reviewed
by
the
Agency.
In
addition,
processing
data
for
field
corn
and
olives
and
a
metabolism
study
in
fish
are
required.
Table
2.
Tolerance
Reassessment
Summary
for
Diuron
10
Commodity
Established
Tolerance
(
ppm)
1
Reassessed
Tolerance
(
ppm)
2
Comment
Correct
Commodity
Definition
Tolerances
Listed
Under
40
CFR
§
180.106(
a)
Alfalfa
2
2/(
TBD3)
[
Alfalfa,
forage]
2.0
[
Alfalfa,
hay]
Apples
1
0.10
The
available
data
indicate
that
the
tolerance
should
be
reduced
to
0.10
ppm.
[
Apple]
Artichokes
1
1/(
TBD)
[
Artichoke,
globe]
Asparagus
7
7.0
Treatment
of
asparagus
is
restricted
to
early
season,
prior
to
the
appearance
of
asparagus
spears.
Bananas
0.1
0.05
This
tolerance
should
be
reclassified
under
180.106(
c),
as
use
of
diuron
on
banana
will
be
restricted
to
HI.
The
available
data
indicate
that
the
tolerance
should
be
reduced
to
0.05
ppm.
[
Banana]
Barley,
grain
1
0.20
These
tolerances
should
be
reclassified
under
180.106(
c),
as
use
of
diuron
on
barley
is
restricted
to
western
OR
and
WA.
The
available
data
indicate
that
the
tolerance
should
be
reduced
to
0.20
ppm
for
barley,
grain;
and
to
1.5
ppm
for
barley,
straw.
Barley,
hay
2
2/(
TBD)
Barley,
straw
(
2)
6
1.5
Birdsfoot
trefoil,
forage
2
0.10
These
tolerances
should
be
reclassified
under
180.106(
c),
as
use
of
diuron
on
trefoil
is
restricted
to
western
OR.
The
available
data
indicate
that
the
tolerance
should
be
reduced
to
0.10
ppm
for
birdsfoot
trefoil,
forage
and
to
0.15
ppm
for
birdsfoot
trefoil,
hay.
Birdsfoot
trefoil,
hay
2
0.15
Blackberries
1
Reassign;
0.10
The
established
tolerances
for
blackberries,
blueberries,
boysenberries,
currants,
dewberries,
gooseberries,
huckleberries,
loganberries,
and
raspberries
should
be
revoked
concomitant
with
the
establishment
of
a
tolerance
for:
The
available
data
indicate
that
these
tolerances
should
be
reduced
to
0.10
ppm.
[
Berry
Group].
Blueberries
1
Boysenberries
1
Currants
1
Dewberries
1
Gooseberries
1
Huckleberries
1
Loganberries
1
Raspberries
1
Commodity
Established
Tolerance
(
ppm)
1
Reassessed
Tolerance
(
ppm)
2
Comment
Correct
Commodity
Definition
11
Cattle,
fat
1
16
Cattle,
meat
1
16
Cattle,
meat
byproducts
1
16
Citrus
fruits
1
1/(
TBD3,
6)
[
Fruit,
citrus,
group]
Citrus
pulp,
dried
4
4/(
TBD)
[
Citrus,
dried
pulp]
Clover,
forage
2
0.10
These
tolerances
should
be
reclassified
under
180.106(
c),
as
use
of
diuron
on
clover
is
restricted
to
western
OR.
The
available
data
indicate
that
the
tolerance
should
be
reduced
to
0.10
ppm
for
clover,
forage
and
to
1
ppm
for
clover,
hay.
Clover,
hay
2
1
Corn
in
grain
or
ear
form
(
including
sweet
corn,
field
corn,
popcorn)
1
0.10
Concomitant
with
the
reassignment
of
this
tolerance,
a
separate
tolerance
should
be
established
for
[
Corn,
field,
grain].
The
available
data
indicate
that
the
tolerance
should
be
reduced
to
0.10
ppm.
1
0.10
Concomitant
with
the
reassignment
of
this
tolerance,
a
separate
tolerance
should
be
established
for
[
Corn,
pop,
grain].
The
available
data
indicate
that
the
tolerance
should
be
reduced
to
0.10
ppm.
1
0.10
Concomitant
with
the
reassignment
of
this
tolerance,
a
separate
tolerance
should
be
established
for
[
Corn,
sweet,
grain].
The
available
data
indicate
that
the
tolerance
should
be
reduced
to
0.10
ppm.
1
0.10
Concomitant
with
the
reassignment
of
this
tolerance,
a
separate
tolerance
should
be
established
for
[
Corn,
field,
ear].
The
available
data
indicate
that
the
tolerance
should
be
reduced
to
0.10
ppm.
1
0.10
Concomitant
with
the
reassignment
of
this
tolerance,
a
separate
tolerance
should
be
established
for
[
Corn,
pop
ear].
The
available
data
indicate
that
the
tolerance
should
be
reduced
to
0.10
ppm.
Commodity
Established
Tolerance
(
ppm)
1
Reassessed
Tolerance
(
ppm)
2
Comment
Correct
Commodity
Definition
12
1
0.10
Concomitant
with
the
reassignment
of
this
tolerance,
a
separate
tolerance
should
be
established
for
[
Corn,
sweet
ear].
The
available
data
indicate
that
the
tolerance
should
be
reduced
to
0.10
ppm.
Corn,
sweet,
fodder
2
Revoke
There
are
no
registered
uses
of
diuron
on
sweet
corn.
Corn,
sweet,
forage
2
Corn,
field
fodder
2
2/(
TBD)
This
tolerance
was
inadvertently
omitted
from
the
1/
14/
98
Final
Rule
technical
amendment
consolidating
40
CFR
parts
185
186
to
40
CFR
part
180.
This
action
will
reinstate
this
tolerance
to
40
CFR
part
180.106.
[
Corn,
field,
stover]
Corn,
pop,
fodder
2
2/(
TBD)
This
tolerance
was
inadvertently
omitted
from
the
1/
14/
98
Final
Rule
technical
amendment
consolidating
40
CFR
parts
185
186
to
40
CFR
part
180.
This
action
will
reinstate
this
tolerance
to
40
CFR
part
180.106.
[
Corn,
pop,
stover]
Corn,
field
forage
2
2/(
TBD)
This
tolerance
was
inadvertently
omitted
from
the
1/
14/
98
Final
Rule
technical
amendment
consolidating
40
CFR
parts
185
186
to
40
CFR
part
180.
This
action
will
reinstate
this
tolerance
to
40
CFR
part
180.106.
[
Corn,
field,
forage]
Corn,
pop,
forage
2
2/(
TBD)
This
tolerance
was
inadvertently
omitted
from
the
1/
14/
98
Final
Rule
technical
amendment
consolidating
40
CFR
parts
185
186
to
40
CFR
part
180.
This
action
will
reinstate
this
tolerance
to
40
CFR
part
180.106.
[
Corn,
pop,
forage]
Cottonseed
1
0.20
The
available
data
indicate
that
the
tolerance
should
be
reduced
to
0.20
ppm.
[
Cotton,
undelinted
seed]
Goats,
fat
1
16
[
Goat,
fat]
Goats,
meat
1
16
[
Goat,
meat]
Goats,
meat
byproducts
1
16
[
Goat,
meat
byproducts]
Grapes
1
0.05
The
available
data
indicate
that
the
tolerance
should
be
reduced
to
0.05
ppm.
[
Grape]
Commodity
Established
Tolerance
(
ppm)
1
Reassessed
Tolerance
(
ppm)
2
Comment
Correct
Commodity
Definition
13
Grass
crops
(
other
than
Bermuda
grass)
2
2/(
TBD)
[
Grass,
forage,
except
Bermuda
grass]
Grass,
hay
(
other
than
Bermuda
grass
hay)
2
2/(
TBD)
[
Grass,
hay,
except
Bermuda
grass]
Hogs,
fat
1
16
[
Hog,
fat]
Hogs,
meat
1
16
[
Hog,
meat]
Hogs,
meat
byproducts
1
16
[
Hog,
meat
byproducts]
Horses,
fat
1
16
[
Horse,
fat]
Horses,
meat
1
16
[
Horse,
meat]
Horses,
meat
byproducts
1
16
[
Horse,
meat
byproducts]
Nuts
0.1
0.1/(
TBD)
Concomitant
with
the
reassignment
of
this
tolerance,
separate
a
separate
tolerance
should
be
established
for
[
Filbert
].
0.05
Concomitant
with
the
reassignment
of
this
tolerance,
separate
a
separate
tolerance
should
be
established
for
[
Nut,
macadamia].
The
available
data
indicate
that
the
tolerance
should
be
reduced
to
0.05
ppm.
0.05
Concomitant
with
the
reassignment
of
this
tolerance,
separate
a
separate
tolerance
should
be
established
for
[
Pecan].
The
available
data
indicate
that
the
tolerance
should
be
reduced
to
0.05
ppm.
0.05
Concomitant
with
the
reassignment
of
this
tolerance,
separate
a
separate
tolerance
should
be
established
for
[
Walnut].
The
available
data
indicate
that
the
tolerance
should
be
reduced
to
0.05
ppm.
Oats,
forage
2
2/(
TBD)
These
tolerances
should
be
reclassified
under
180.106(
c),
as
use
of
diuron
on
oats
is
restricted
to
ID,
OR,
and
WA.
The
available
data
indicate
that
the
tolerance
should
be
reduced
to
0.10
ppm
for
oats,
grain;
and
to
1.5
ppm
for
oats,
straw.
Oats,
grain
1
0.10
Oats,
hay
2
2/(
TBD)
Oats,
straw
2
1.5
Olives
1
1/(
TBD)
[
Olive]
Papayas
0.5
0.50
[
Papayas]
Commodity
Established
Tolerance
(
ppm)
1
Reassessed
Tolerance
(
ppm)
2
Comment
Correct
Commodity
Definition
14
Peaches
0.1
0.10
[
Peach]
Pears
1
1/(
TBD)
[
Pear]
Peas
1
0.10
The
available
data
indicate
that
the
tolerance
should
be
reduced
to
0.10
ppm.
[
Pea,
field,
seed]
Peas,
forage
2
2/(
TBD)
[
Pea,
field,
vines]
Peas,
hay
2
2/(
TBD)
[
Pea,
field,
hay]
Peppermint,
hay
2
1.5
The
available
data
indicate
that
the
tolerance
should
be
reduced
to
1.5
ppm.
[
Peppermint,
tops]
Pineapple
1
0.10
The
available
data
indicate
that
the
tolerance
should
be
reduced
to
0.10
ppm.
Potatoes
1
Revoke
There
are
no
registered
uses
of
diuron
on
potatoes.
Rye,
forage
2
Revoke
There
are
no
registered
uses
of
diuron
on
rye.
Rye,
grain
1
Rye,
hay
2
Rye,
straw
2
Sheep,
fat
1
16
Sheep,
meat
1
16
Sheep,
meat
byproducts
1
16
Sorghum,
fodder
2
2/(
TBD)
[
Sorghum,
grain,
stover]
Sorghum,
forage
2
2/(
TBD)
[
Sorghum,
grain,
forage]
Sorghum,
grain
1
0.50
The
available
data
indicate
that
the
tolerance
should
be
reduced
to
0.50
ppm.
[
Sorghum,
grain,
grain]
Sugarcane
1
0.20
The
available
data
indicate
that
the
tolerance
should
be
reduced
to
0.20
ppm.
Vetch,
forage
2
0.10
These
tolerances
should
be
reclassified
under
180.106(
c),
as
use
of
diuron
on
vetch
is
restricted
to
ID,
OR,
and
WA.
The
available
data
indicate
that
these
tolerances
should
be
reduced
to
0.10
ppm
for
vetch,
forage
and
to
1.5
ppm
for
vetch,
hay.
Vetch,
hay
2
1.5
Vetch,
seed
1
Revoke
No
longer
considered
a
significant
livestock
feed
item.
Commodity
Established
Tolerance
(
ppm)
1
Reassessed
Tolerance
(
ppm)
2
Comment
Correct
Commodity
Definition
15
Wheat,
forage
2
2/(
TBD)
Wheat,
grain
1
0.50
The
available
data
indicate
that
the
tolerance
should
be
reduced
to
0.50
ppm.
Wheat,
hay
2
2/(
TBD)
Wheat,
straw
2
1.5
The
available
data
indicate
that
the
tolerance
should
be
reduced
to
1.5
ppm.
Tolerance
Listed
Under
40
CFR
§
180.106(
b)
Catfish
fillets
2.04
2.0
Expiration
date
of
06/
30/
03
[
Catfish]
Tolerances
To
Be
Proposed
Under
40
CFR
§
180.106(
a)
Aspirated
grain
fractions
N/
A
5.0
Barley,
bran
N/
A
0.7
Citrus,
oil
N/
A
TBD
Cotton,
gin
byproducts
N/
A
TBD
Eggs
N/
A
TBD
Grass,
seed
screenings
N/
A
TBD
Grass,
straw
N/
A
TBD
Milk
N/
A
TBD
Pineapple,
process
residue
N/
A
0.40
Poultry,
meat
byproducts
N/
A
TBD
Prickly
pear
N/
A
0.05
Spearmint
N/
A
1.5
Sugarcane,
molasses
N/
A
0.70
Wheat,
bran
N/
A
0.70
1.
Expressed
as
diuron
per
se,
unless
otherwise
stated.
2.
To
be
expressed
as
the
combined
residues
of
diuron
and
its
metabolites
convertible
to
3,4
DCA,
expressed
as
diuron.
The
residues
of
3,4
DCA
are
low
but
diuron
residues
are
converted
to
3,4
DCA
for
the
tolerance
expression
based
on
the
assumption
that
the
metabolites
would
not
be
any
more
toxic
than
diuron
and
the
consideration
that
the
analytical
methods
used
to
collect
the
field
trial
data
are
not
capable
of
measuring
each
metabolite
individually.
The
reassessed
tolerances
are
contingent
upon
the
recommended
label
revisions
outlined
in
Table
B
of
the
Residue
Chemistry
Chapter
16
For
The
Diuron
Reregistration
Eligibility
Decision
(
RED)
Document,
dated
7/
29/
2001.
3.
TBD
=
To
be
determined.
These
commodities
were
included
in
the
dietary
risk
assessment
using
the
Current
Tolerance
level.
Additional
confirmatory
field
trial
residue
data
are
required;
therefore,
the
final
tolerance
may
be
revised.
4.
Expressed
as
combined
residues
of
diuron
and
its
metabolites
convertible
to
3,4
DCA.
5.
Feeding
study
data
have
been
submitted
to
reassess
the
established
tolerances
for
the
fat,
meat,
and
meat
byproducts
of
cattle,
goats,
hogs,
horses,
and
sheep.
Residue
data
are
not
available
for
several
potential
feed
items.
If
the
maximum
dietary
burden
does
not
increase
when
recalculated
from
all
potential
feed
items
after
acceptable
field
trial
data
are
submitted
then
the
established
tolerances
for
residues
in
fat,
meat,
and
meat
byproducts
of
cattle,
goats,
hogs,
horses,
and
sheep
can
be
lowered.
6.
Residue
data
to
support
the
9.6
lbs
ai/
A
per
year
rate
on
citrus
are
required.
The
registrant
may
provide
data
to
support
this
use
rate
or
change
the
labels
to
reflect
the
use
rate
of
6.4
lbs
ai/
A
per
year,
as
supported
by
current
residue
data.
17
No
maximum
residue
limits
(
MRLs)
for
diuron
have
been
established
by
Codex
for
any
agricultural
commodity.
If
you
have
questions
on
this
document,
please
contact
the
Chemical
Review
Manager,
Diane
Isbell,
at
(
703)
308
8154.
Sincerely,
Lois
A.
Rossi,
Director
Special
Review
and
Reregistration
Division
Enclosure:
Overview
of
the
Diuron
Risk
Assessment
Diuron
Summary
| epa | 2024-06-07T20:31:43.492629 | regulations | {
"license": "Public Domain",
"url": "https://downloads.regulations.gov/EPA-HQ-OPP-2002-0249-0004/content.txt"
} |
EPA-HQ-OPP-2002-0249-0005 | Supporting & Related Material | "2002-10-01T04:00:00" | null | Page
1
of
72
U.
S.
ENVIRONMENTAL
PROTECTION
AGENCY
WASHINGTON,
DC
20460
OFFICE
OF
PREVENTION,
PESTICIDE
AND
TOXIC
SUBSTANCES
PC
Code
No.
035505
DP
Barcode:
D275045
MEMORANDUM
SUBJECT:
Environmental
Risk
Assessment
for
the
Reregistration
of
Diuron
TO:
Margaret
Rice,
PM
#
52/
Roberta
Farrell,
CRM
Reregistration
Branch
Special
Review
and
Reregistration
Division
(
7508C)
FROM:
Richard
Lee,
Ph.
D.,
Biologist
Ibrahim
Abdel
Saheb,
Agronomist
James
Breithaupt,
Agronomist
Environmental
Fate
and
Effects
Division
(
7507C)
THROUGH:
Thomas
Bailey,
Ph.
D.,
Chief
Environmental
Risk
Branch
II,
EFED
(
7507C)
Attached
is
the
Environmental
Fate
and
Effects
Division's
(
EFED)
environmental
risk
assessment
for
the
diuron
RED
(
Case
#
818790).
The
attached
documents
contain
drop
in
chapters
for
the
environmental
fate
and
transport
assessment,
the
ecological
risk
assessment,
integrated
risk
characterization,
and
drinking
water
assessment.
Page
2
of
72
Summary
of
Drinking
Water
and
Ecological
Risk
Drinking
Water
C
Diuron
is
persistent,
mobile,
and
has
been
found
in
both
surface
and
ground
water.
Parent
diuron
is
frequently
detected
in
surface
water
and
ground
water
with
concentration
ranging
from
2.7
2849
ppb
in
surface
water
and
0.34
5.37
ppb
in
groundwater.
However,
available
monitoring
data
may
not
fully
reflect
diuron's
temporal
and
spacial
variability.
Therefore,
frequent
detection
of
diuron
residues
and
occasionally
high
residues
in
the
monitoring
studies
along
with
incident
reports
confirm
EFED
concerns
for
aquatic
plants
and
animals.
If
any
intakes
are
located
downstream
from
diuron
use
areas,
these
intakes
will
likely
receive
get
some
exposure
from
drinking
water.
Also,
if
any
wells
draw
ground
water
in
diuron
use
areas,
there
is
some
possibility
of
exposure.
C
The
metabolite,
3,4
DCA,
is
of
concern
to
human
health
and
has
been
found
in
the
environment
in
surface
water.
It
is
formed
from
applied
diuron,
linuron,
and
propanil.
Because
of
its
persistence
and
degradation
pathway,
diuron
produces
less
3,4
DCA
than
propanil
and
possibly
linuron.
Based
on
limited
environmental
fate
data,
3,4
DCA
is
formed
at
<
1
%
of
applied
diuron.
However,
measurements
of
3,4
DCA
from
surface
water
monitoring
studies
in
five
southern
states
reached
up
to
26
ppb
in
the
Yazoo
River
Basin
where
both
propanil
and
diuron
are
used
extensively.
However,
there
are
no
nearby
surface
water
intakes
where
the
highest
concentrations
were
observed.
Although
it
is
commonly
seen
in
surface
water
in
areas
with
high
diuron
and
propanil
usage,
EFED
has
received
no
guideline
studies
on
ecological
effects
or
environmental
fate
and
transport
of
3,4
DCA.
EFED
believes
that
at
minimum
laboratory
studies
are
needed
to
fully
understand
both
the
fate
and
transport
and
the
impact
on
fish
and
wildlife
from
3,4
DCA.
Terrestrial
Organisms
°
Potential
acute
risk
to
birds
based
on
maximum
labeled
rates
from
high
application
sites
(
right
of
ways,
grapes,
and
citrus)
using
6.4
12
lbs
ai/
A.
C
Potential
risk
of
reproductive
impairment
to
birds
is
assumed
because
of
persistence
but
is
uncertain
due
to
need
for
additional
data
for
confirmation.
C
Potential
acute
risk
to
small
mammals
feeding
in
short
grass
treated
with
diuron
at
a
rate
of
12
lbs
ai/
A.
C
Potential
chronic
risk
to
mammals
at
all
application
rates
C
Potential
risk
to
terrestrial
plants
at
all
application
rates
Page
3
of
72
Aquatic
Organisms
C
Potential
acute
risk
to
freshwater
fish
at
a
one
time
rate
of
12
lbs
ai/
A
for
right
of
way
use
C
Potential
acute
risk
to
freshwater
invertebrates
at
one
time
rates
of
3.2
lbs
ai/
A
and
above
C
Potential
chronic
risk
to
freshwater
fish
and
invertebrates
at
one
time
rates
of
9.6
lbs
and
above
C
Potential
chronic
risk
to
estuarine
invertebrates
from
a
one
time
rate
of
12
lbs
ai/
A
C
High
potential
for
risk
to
aquatic
plants
from
all
application
rates.
Outstanding
Data
Requirement
Requirements
for
Additional
Data
Required
Study
Guideline
Number
Environmental
Fate
Upgrade
of
leaching
adsorption
desorption
(
material
balances
for
definitive
study
needed,
44490501)
163
1
Hydrolysis
of
3,4
DCA
161
1
Aerobic
Soil
Metabolism
of
3,4
DCA
162
1
Aerobic
Aquatic
Metabolism
of
3,4
DCA
162
4
Leaching
Adsorption
Desorption
of
3,4
DCA
163
1
Ecological
Effects
Avian
reproduction
study
(
based
on
persistence
of
diuron)
71
4
Freshwater
aquatic
invertebrate
early
life
cycle
toxicity
study
(
previous
study
failed
to
establish
NOAEC
72
4(
b)
Estuarine/
marine
fish
early
life
stage
toxicity
study
(
previous
study
failed
to
establish
NOAEC)
72
4(
a)
Nontarget
aquatic
plant
toxicity
study
a
123
2
Avian
dietary
LC50
3,4
DCA
71
2
(
a)
Freshwater
fish
LC50
3,4
DCA
72
1
(
b)
Page
4
of
72
Freshwater
invertebrate
acute
LC50
3,4
DCA
72
2
Nontarget
terrestrial
plant
seedling
emergency
toxicity
b
(
Tier
II)
3,4
DCA
123
1
Nontarget
terrestrial
plant
vegetative
vigor
toxicity
(
Tier
II)
3,4
DCA
b
123
1
Nontarget
aquatic
plant
toxicity
3,4
DCA
c
123
2
a
This
study
is
required
for
herbicides.
The
study
should
include
four
species
of
aquatic
plants
(
Kirchneria
subcapitata,
Anabaena
flosaquae,
a
freshwater
diatom,
and
duckweed
,
Lemna
gibba).
b.
Tomato
and
onion
c
.
Skeletonema
costatum
and
lema
gibbs
A
complete
listing
of
submitted
data
and
data
requirements
for
environmental
fate
and
transport,
and
modeling
input
and
output
data,
and
the
ecological
effects
characterization
may
be
found
in
Appendices
1,
2,
and
3
of
the
EFED
RED
Chapter,
respectively.
Recommended
Label
Language
The
following
precautionary
statements
should
be
included
on
both
manufacturing
and
end
use
product
labels
Page
5
of
72
Environmental
Hazards
i.
Non
aquatic
use
°
This
pesticide
is
toxic
to
fish
and
aquatic
invertebrates.
Do
not
apply
directly
to
water,
to
areas
where
surface
water
is
present,
or
to
intertidal
areas
below
the
mean
high
water
mark.
Drift
and
runoff
may
be
hazardous
to
aquatic
organisms
in
water
adjacent
to
treated
areas.
Do
not
contaminate
water
when
disposing
of
equipment
wash
waters
or
rinsate."
ii.
Aquatic
use
°
Treatment
of
aquatic
weeds
can
result
in
oxygen
loss
from
decomposition
of
dead
weeds.
This
loss
can
cause
fish
suffocation.
Therefore,
to
minimize
this
hazard
,
treat
1/
3
to
½
of
the
water
area
in
a
single
operation
and
wait
at
least
10
to
14
days
between
treatments.
Begin
treatment
along
the
shore
and
proceed
outwards
in
bands
to
allow
fish
to
move
into
untreated
areas.
Consult
with
the
State
agency
in
charge
of
fish
and
game
before
applying
to
public
waters
to
determine
if
a
permit
is
needed.
°
Observe
all
cautions
and
limitations
on
labeling
of
all
products
used
in
mixtures.
Surface
Water
Label
Advisory
This
product
may
contaminate
water
through
drift
of
spray
in
wind.
This
product
has
a
potential
for
runoff
according
to
the
pesticides
"
mean"
soil
partition
coefficient
(
Kd)
for
several
months
or
more
after
application.
Poorly
draining
soils
and
soils
with
shallow
watertables
are
more
prone
to
produce
runoff
that
contains
this
product.
A
level,
well
maintained
vegetative
buffer
strip
between
areas
to
which
this
product
is
applied
and
surface
water
features
such
as
ponds,
streams,
and
springs
will
reduce
the
potential
for
contamination
of
water
from
rainfall
runoff.
Runoff
of
this
product
will
be
reduced
by
avoiding
applications
when
rainfall
is
forecasted
to
occur
within
48
hours.
Sound
erosion
control
practices
will
reduce
this
product's
contribution
to
surface
water
contamination.
Ground
Water
Advisory
Diuron
is
known
to
leach
through
soil
and
into
ground
water
under
certain
conditions
as
a
result
of
label
use.
Use
of
this
product
in
areas
where
soils
are
permeable,
particularly
where
the
water
table
is
shallow,
may
result
in
ground
water
contamination.
Environmental
Fate
and
Ecological
Risk
Assessment
for
the
Re
Registration
of
Diuron
N'(
3,4
dichlorophenyl)
N'N
dimethylurea
Prepared
by:
Richard
Lee
Ibrahim
Abdel
Saheb
James
Breithaupt
U.
S.
Environmental
Protection
Agency
Office
of
Pesticide
Programs
Environmental
Fate
and
Effects
Division
Environmental
Risk
Branch
IV
401
M
Street,
SW
Mail
Code
7507C
Washington,
DC
20460
Reviewed
by:
Tom
Bailey,
Ph.
D.,
Branch
Chief
Page
2
of
72
TABLE
OF
CONTENTS
ENVIRONMENTAL
RISK
CONCLUSIONS
.
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4
INTRODUCTION
.
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4
Mode
of
action
.
.
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.
4
Use
Characterization
.
.
.
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.
4
Application
Rates
and
Methods
.
.
.
.
.
.
.
.
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.
5
Chemical
and
Physical
Properties
.
.
.
.
.
.
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.
5
ENVIRONMENTAL
RISK
CHARACTERIZATION
.
.
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.
6
ENVIRONMENTAL
FATE
AND
TRANSPORT
ASSESSMENT
.
.
.
.
.
.
.
.
.
.
.
.
.
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.
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.
.
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.
.
.
7
Summary
.
.
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.
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.
8
Water
Resource
Assessment
.
.
.
.
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8
Surface
Water
.
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.
8
Ground
Water
.
.
.
.
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.
9
Drinking
Water
Recommendations
.
.
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.
.
.
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.
10
ECOLOGICAL
EFFECTS
ASSESSMENT
.
.
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.
11
ECOLOGICAL
RISK
ASSESSMENT
.
.
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.
14
Nontarget
Terrestrial
Animals
.
.
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.
14
Nontarget
Aquatic
Anima
.
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18
Nontarget
Plants
.
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21
ENDANGERED
SPECIES
.
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22
ENVIRONMENTAL
MODELING
AND
MONITORING
REFERENCES
.
.
.
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.
24
APPENDIX
1:
SUMMARY
OF
SUBMITTED
ENVIRONMENTAL
FATE
STUDIES
.
.
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.
26
Degradation
.
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26
Metabolism
.
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27
Mobility
.
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27
APPENDIX
2:
SCI
GROW,
GENEEC
AND
IR
PCA
PRZM/
EXAMS
FOR
ECOLOGICAL
Page
3
of
72
EFFECTS
AND
DRINKING
WATER
ASSESSMENTS
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28
Background
Information
on
SCI
GROW
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28
SCI
GROW
Output
.
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29
Background
Information
on
GENEEC2
.
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29
GENEEC2
Output.........................................................................................................
30
IR
PCA
PRZM/
EXAMS
Input
and
Output
Files
for
Various
Crops
.
.
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.
35
APPENDIX
3:
ECOLOGICAL
EFFECTS
CHARACTERIZATION
.
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56
APPENDIX
4:
ENVIRONMENTAL
FATE
AND
TRANSPORT
STUDIES
REVIEWED
..
.
.
.
68
Page
4
of
72
ENVIRONMENTAL
RISK
CONCLUSIONS
Diuron
has
a
wide
range
of
application
rates
(
1.6
to
12
lbs
ai/
A),
but
the
higher
application
rates
are
used
for
row
or
spot
treatments
of
nonagricultural
sites,
grape
vineyards
and
orchards.
It
is
stable
to
hydrolysis
and
photolysis
and
very
persistent
on
soil.
It
is
moderately
mobile
and
has
been
found
in
ground
water
and
surface
water.
The
major
metabolites
are
sequentially
demethylated
diuron
compounds,
DCPMU
and
DCPU,
which
have
no
herbicidal
effects.
The
ecological
effects
of
the
minor
metabolite
3,4
DCA
are
unknown.
Based
on
the
likelihood
of
environmental
exposure
and
high
RQ
values,
diuron
poses
potential
risk
to
terrestrial
and
aquatic
animals
and
nontarget
terrestrial
and
aquatic
plants.
For
animals,
the
acute
RQ
values
based
on
the
maximum
exposures
are
as
follows:
mammals
(
1.19
9.22),
avian
(<
1.16),
and
aquatic
animals
(
1.35
9.00).
For
plants,
the
acute
RQ
values
ranged
from
1.25
76.5,
and
the
endangered
species
RQ
values
ranged
from
6.5
306.
No
avian
chronic
data
are
available,
but
exposure
and
risk
are
expected
to
be
high
because
of
diuron's
persistence
in
environment.
Finally,
environmental
monitoring
studies
have
routinely
confirmed
diuron
residues
at
occasional
high
concentrations
in
both
surface
and
ground
water.
OPP's
Ecological
Incident
Information
System
(
EIIS)
summary
report
confirmed
29
cases
of
incidents
involving
nontarget
organism
that
occurred
mostly
in
the
1990'
s.
Of
the
29
incidents,
one
included
birds,
16
involved
fish,
and
12
involved
plants.
EFED
believes
that
the
reported
incidents
are
only
a
subset
of
the
total
number
of
incidents
that
are
likely
occurring
because
of
uncertainty
due
to
spacial
and
temporal
variation
of
monitoring
studies
and
voluntary
incident
reporting.
INTRODUCTION
Diuron
(
PC
Code
035505)
is
a
pre
emergence
contact
herbicide
belonging
to
the
substituted
urea
herbicides.
Diuron
is
the
common
name
for
3(
3,4
dichloro
phenyl)
1,1
dimethyl
urea.
It
is
formulated
as
a
wettable
powder
and
as
a
flowable
liquid
suspension.
Mode
of
action
Diuron
is
a
strong
inhibitor
of
the
Hill
Reaction
in
plant
photosynthesis.
This
inhibition
prevents
the
formation
of
high
energy
compounds,
i.
e.
ATP
and
NADPH,
which
are
required
for
carbon
dioxide
fixation
and
numerous
other
biochemical
reactions.
Page
5
of
72
Use
characterization
Diuron
is
registered
on
both
agricultural
and
non
agricultural
use
sites,
and
is
used
in
combination
with
other
herbicides
to
control
a
wide
variety
of
weeds.
Diuron
is
used
primarily
as
a
pre
emergent
herbicide
to
control
annual
grasses
and
broadleaf
weeds
in
crops
such
as
alfalfa,
artichoke,
asparagus,
bananas,
barley,
Bermuda
grass
pastures,
blueberries,
cranberries,
gooseberries,
corn,
cotton,
grapes,
perennial
grass
seed
crops,
papayas,
peppermint,
pineapple,
plantains,
sorghum,
sugarcane,
small
grains,
and
several
fruit
and
nut
tree
crops
as
well
as
certain
ornamentals.
For
these
selective
uses,
the
application
rates
are
relatively
low,
usually
1
4
lbs/
A.
Diuron
is
usually
applied
in
conjunction
with
surfactants.
Application
rates
and
Methods
Table
1
below
summarizes
the
various
usages,
application
rates,
and
application
methods
for
diuron.
In
addition
to
the
maximum
labeled
rates,
Table
1
includes
the
typical
application
rates
used
by
80
%
of
growers,
according
to
the
registrant's
survey.
The
higher
application
rates
(
6.4
12
lbs.
ai/
A)
are
for
nonagricultural
sites
and
some
crops
such
as
grapes
and
citrus.
The
typical
application
rates
are
usually
50
80
%
lower
than
labeled
rates.
Table
1.
List
of
maximum
labeled
application
rates
and
methods
for
diuron
End
uses
Appl.
Methods
*
Max.
Label
Rates
(
lbs
ai)
Typical
Rates(
lbs
ai)
Seasonal
Max.
Rate
Non
Agricultural
Railroad
A/
G
12
6
12
Roadside,
utilities,
irrigation,
drainage
ditch
G
12
6
12
Non
Agricultural
grape
G
9
.6
2.0
9.6
citrus
G
6
.4
3.2
9.6
Alfalfa
A/
G
3.
2
2.4
3.2
Fruits
(
Peach,
Apple,
Pear)
G
3.2
4.0
3.2
4.0
Sugarcane
A/
G
3.
2
2.4
9.6
Grass
seeds
A/
G
3.2
1.5
3.2
Cotton
A/
G
1.6
0.8
2.2
A
=
Aerial,
G
=
Ground
Chemical
and
Physical
properties
Page
6
of
72
Common
Name:
Diuron
Trade
Name(
s):
Karmex,
Krovar,
Direx,
Dailon,
Herbixol,
Tigrex,
Unidron,
Vonduron,
Crisuron.
Chemical
Name:
N'(
3,4
Dichlorophenyl)
N,
N
dimethylurea.
Chemical
Abstract
Registry
No.:
330
54
1
Type
of
Product:
Herbicide
ENVIRONMENTAL
RISK
CHARACTERIZATION
Summary
of
Risk
Assessment
Note:
Conclusions
of
ecological
risk
are
based
on
a
screening
level
assessment.
In
the
past,
these
risks
would
have
been
characterized
as
"
high"
acute
or
chronic
risk.
However,
recognizing
the
uncertainty
in
the
ability
of
a
screening
level
assessment
to
quantify
the
level
or
significant
of
risk,
the
EFED
is
changing
the
wording
of
the
conclusions
when
exceeding
the
LOC
is
based
solely
on
screening
level
risk
assessment.
This
change
does
not
reflect
a
change
in
the
risk
assessment
process,
or
alter
the
criteria
of
exceeding
the
LOC's.
Also,
it
does
not
change
the
other
presumptions
of
risk,
including
those
related
to
restricted
use
and
endangered
species.
The
major
concerns
for
diuron
are
C
risk
to
plants
C
acute
and
chronic
risk
to
aquatic
organisms
and
mammals
C
suspected
chronic
risk
to
birds
due
to
high
application
rates
and
persistence
The
major
ecological
concern
from
the
use
of
diuron
is
the
impact
on
non
target
plants,
both
terrestrial
and
aquatic.
All
RQ
s
exceeded
the
level
of
concern
for
both
terrestrial
and
aquatic
non
target
plants.
The
terrestrial
plant
RQ
values
ranged
from
1.25
77
for
acute
effects
and
5
306
for
endangered
plants.
The
aquatic
plant
RQ
values
ranged
from
9.6
to
171.7,
indicating
acute
risk
to
aquatic
plants.
Another
environmental
risk
concern
is
acute
and
chronic
risk
to
terrestrial
and
aquatic
non
target
organisms.
These
risks
are
expected
to
increase
with
increasing
application
rate.
The
sites
with
the
higher
broadcast
application
rates
include
non
agricultural
sites
(
12
lbs.
ai/
A),
grape
vineyards
(
9.6
lbs.
ai/
A.),
and
orchards
(
6.4
lbs.
ai/
A).
Non
agricultural
sites
include
rights
of
way
(
e.
g.
sides
of
roads
and
railroads),
utilities,
and
areas
around
industrial
buildings.
However,
diuron
is
applied
as
a
spot
treatment
for
these
uses.
Spot
treatment
refers
to
application
to
part
of
an
area,
and
as
a
result,
the
probability
of
ecological
exposure
will
increase
with
the
percent
of
the
area
treated.
For
vineyards
and
orchards,
row
treatments
are
used
where
only
part
of
the
field
is
treated.
Approximately
33
%
of
the
area
in
a
vineyard
Page
7
of
72
may
be
treated,
while
only
45
%
of
a
citrus
orchard
may
be
treated.
Therefore,
application
rates
for
these
crops
are
2.9
3.2
lbs
ai/
A
instead
of
the
6.4
9.6
lbs
ai/
A
broadcast
rates.
Even
with
these
reduced
application
rates
in
vineyards
and
citrus,
our
level
of
concern
is
still
exceeded
for
endangered
species
of
non
target
terrestrial
organisms
(
birds
and
mammals).
Due
to
persistence,
organisms
may
be
exposed
to
toxic
residuals
for
extended
periods
of
time.
In
addition,
EFED
has
concerns
for
acute
and
chronic
risk
to
birds.
At
an
application
rate
of
4
lbs
ai/
A,
there
are
potential
acute
risks
on
birds.
EFED
assumes
chronic
risk
to
birds
because
diuron
is
persistent,
and
a
rat
study
showed
chronic
effects
to
mammals
(
reduced
pup
body
weight).
However,
EFED
cannot
confirm
chronic
risk
to
birds
because
we
have
received
no
studies
on
the
effects
of
diuron
on
avian
reproduction.
Reported
Diuron
Incidents
There
are
29
ecological
incident
reports
for
nontarget
organisms,
reported
mainly
in
1990'
s.
Of
the
29
incidents,
one
involved
birds,
16
involved
fish,
and
12
involved
plants,
of
which
one
case
included
tissue
analysis
for
both
fish
and
plants.
EFED
believes
that
the
reported
incidents
are
only
a
subset
of
the
total
number
of
incidents
that
are
likely
occurring
because
of
uncertainty
due
to
spacial
and
temporal
variation
of
monitoring
studies
and
voluntary
incident
reporting.
Metabolite
3,4
DCA
The
metabolite,
3,4
DCA,
is
of
concern
to
human
health.
It
is
formed
from
applied
diuron,
linuron,
and
propanil.
Because
of
its
persistence
and
degradation
pathway,
diuron
produces
less
3,4
DCA
than
propanil
and
possibly
linuron.
Although
it
is
commonly
seen
in
surface
water
in
areas
with
high
diuron
and
propanil
usage,
EFED
has
received
no
guideline
studies
on
ecological
effects
or
environmental
fate
and
transport
of
3,4
DCA,.
EFED
believes
that
at
least
laboratory
studies
are
needed
to
fully
understand
both
the
fate
and
transport
and
the
impact
on
fish
and
wildlife
from
3,4
DCA.
Exposure
Issues
Typical
Application
Rates
and
Effect
on
Ecological
Risk
The
typical
application
rates
for
diuron
are
lower
than
the
maximum
labeled
rates.
However,
even
the
typical
rates
of
diuron
exceed
our
level
of
concern
for
plants.
Based
on
a
survey
by
the
registrant,
the
typical
rates
applied
by
80
%
of
users
are
20
50%
of
label
rates.
In
addition
to
the
registrant
survey,
average
weighted
application
rates
are
about
half
the
maximum
labeled
rates
based
on
BEAD's
QUA.
The
QUA
also
claims
that
rates
for
agricultural
sites
are
generally
less
than
2
pounds
ai/
A,
and
not
exceeding
3
pounds
ai/
A/
year.
It
also
claims
that
rates
for
non
agricultural
sites
are
generally
less
than
6
pounds
ai/
A/
year.
EFED
recommends
that
these
typical
rates
be
put
on
the
label
as
the
maximum
rates
so
that
ecological
exposure
and
risk
to
terrestrial
and
aquatic
animals
may
be
reduced.
Page
8
of
72
Page
9
of
72
ENVIRONMENTAL
FATE
AND
TRANSPORT
ASSESSMENT
Summary
Diuron
is
persistent.
It
is
stable
to
hydrolysis
at
pH's
5,
7,
and
9.
The
calculated
half
lives
in
aqueous
and
soil
photolysis
studies
were
43
and
173
days,
respectively.
The
half
lives
in
aerobic
and
anaerobic
soil
metabolism
studies
were
372
and
1000
days,
respectively.
However,
in
viable
laboratory
aquatic
systems,
degradation
appeared
to
be
accelerated
with
half
lives
of
33
and
5
days
in
aerobic
and
anaerobic
systems,
respectively.
The
predominant
degradate
formed
in
both
the
soil
photolysis
and
aerobic
soil
metabolism
studies
was
DCPMU.
The
only
significant
(>
10
%
of
applied)
degradate
in
the
aerobic
and
anaerobic
aquatic
metabolism
studies
was
mCPDMU.
Diuron
dissipated
in
bare
ground
plots
with
half
lives
ranging
from
73
to
133
days,
and
the
major
degradate
(
mCPDMU)
dissipated
in
the
same
plots
with
halflives
range
from
217
to
1733
days.
Diuron
and
mCPDMU
residues
were
detected
mainly
at
the
upper
15
30
cm
depths
at
all
sites
and
sporadically
detected
below
this
depth.
Diuron
has
the
potential
to
leach
to
ground
and
to
contaminate
surface
waters.
An
upgradable
adsorption/
desorption/
leaching
study
(
MRID
#
44490501)
showed
that
diuron
has
low
medium
Koc
(
468
1666).
In
addition,
diuron
has
low
water
solubility
(
42
ppm).
The
degradate
3,4
DCA
is
a
common
degradate
for
diuron,
linuron,
and
propanil.
EFED
does
not
have
sufficient
fate
and
transport
data
on
3,4
DCA.
This
compound
from
applied
propanil
dissipated
in
an
aerobic
soil
metabolism
study
with
a
half
life
of
30
days
(
MRID#
41537801),
and
in
paddy
water
with
half
lives
ranging
from
2
3
days
(
MRID#
42200401,
42200501).
Even
though
these
studies
suggest
that
3,4
DCA
will
not
persist
in
soil
or
water,
3,4
DCA
has
been
detected
often
in
surface
water.
Thus,
more
data
is
needed
to
understand
the
fate
of
this
degradate
in
soil
and
water.
Tetrachloroazobenzene
(
TCAB),
also
a
degradate
of
concern
for
human
health,
was
identified
as
one
of
the
minor
degradates
of
diuron
in
a
soil
photolysis
study
(
MRID
No.
41719302)
with
a
maximum
concentration
of
0.038
ppm.
Water
Resources
Assessment
Surface
Water
EFED
has
limited
monitoring
data
on
the
concentrations
of
diuron
in
surface
water
at
the
present
time.
Therefore,
the
ecological
effects
and
drinking
water
assessments
will
be
bounded,
using
monitoring
as
a
lower
bound
of
exposure
and
modeling
as
an
upper
bound
of
exposure.
based
on
environmental
modeling
and
exposure
summary
of
monitoring
data
will
be
provided
to
place
the
modeling
in
proper
context.
Page
10
of
72
3,4
DCA
is
a
common
degradate
for
diuron,
linuron,
and
propanil.
3,4
DCA
from
propanil
dissipated
in
aerobic
metabolism
study
with
a
half
life
of
30
days
(
MRID#
41537801),
and
in
paddy
water
with
half
lives
range
from
2
3
days
(
MRID#
42200401,
42200501).
Thus,
the
limited
available
fate
characteristics
suggest
that
3,4
DCA
is
not
expected
to
persist
in
soil
or
water.
More
fate
studies
is
needed
to
fully
understand
the
fate
of
this
degradate
in
the
environment.
A
study
on
the
occurrence
of
cotton
herbicides
and
insecticides
in
Playa
lakes
of
the
high
plains
of
western
Texas
concluded
that
diuron
was
the
major
pesticide
detected
in
water
samples
collected
from
32
lakes
with
a
mean
concentration
of
2.7
ppb
(
Thurman
et
al,
2001).
Diuron
metabolites
(
DCPMU,
DCPU,
and
3,4
DCA)
were
found
in
71%
of
the
samples
analyzed.
The
mean
concentrations
were
0.45
ppb
for
DCPMU,
0.31
ppb
for
3,4
DCA,
and
0.2
ppb
for
DCPU.
In
this
study,
water
samples
were
taken
within
two
days
after
diuron
application
to
cotton
in
the
region.
Diuron
usage
on
cotton
in
this
part
of
the
state
reached
an
average
of
$
1379
lb
ai/
mile2/
yr.
Even
though
the
use
of
diuron
on
cotton
in
this
part
of
the
state
is
representative
of
actual
use
area,
the
frequency
of
surface
water
sampling
and
the
length
of
sampling
period
were
insufficient
to
satisfy
the
temporal
and
spatial
requirements
for
regulatory
purposes.
This
study
has
limited
use
in
a
national
assessment
because
we
do
not
expect
western
Texas
to
be
one
of
the
most
vulnerable
areas
for
runoff.
However,
because
the
samples
were
taken
within
two
days
after
application,
the
results
may
represent
a
lower
bound
of
possible
peak
concentrations
that
could
occur
in
drinking
water
in
that
area.
The
US
Geological
Survey
(
USGS)
National
Water
Quality
Assessment
Program
(
NAWQA)
collected
1420
surface
water
samples
from
62
agricultural
stream
sites
during
the
period
from
1992
1998
(
USGS,
1998).
One
to
two
samples
were
collected
each
month
during
periods
when
pesticide
transport
in
the
streams
was
expected
to
be
low.
At
most
sites,
the
sampling
frequency
was
increased
to
1
to
3
samples
per
week
during
periods
when
elevated
levels
of
pesticides
were
expected
in
the
streams.
Diuron
was
detected
in
7.32%
of
the
samples
(
detection
limit
=
0.05
ppb)
with
a
maximum
concentration
of
13
ppb
(
estimated
concentration).
Even
though,
the
surface
water
monitoring
data
collected
by
NAWQA
are
from
sites
considered
typical
use
areas,
the
frequency
of
sampling
and
the
length
of
sampling
period
were
not
sufficient
to
represent
the
temporal
and
spatial
requirements
for
regulatory
purposes.
An
edge
of
plot
right
of
way
study
was
conducted
in
the
state
of
California
from
September
1991
November
1991.
Sampling
of
runoff
events
showed
that
diuron
was
detected
in
100%
of
the
samples
with
a
maximum
detection
of
2849
ppb
(
Powell
et
al.,
1996).
Monitoring
has
also
shown
high
concentrations
of
3,4
DCA
in
smaller
streams
such
as
bayous,
creeks,
and
rivers.
In
MS,
MO,
TN,
AR,
and
North
LA,
Harris
(
2001)
reported
that
3,4
DCA
did
not
exceed
26
ppb
in
surface
water
(
96.2%
detection
rate,
333
detections,
13
non
detections).
The
overall
concentrations
ranged
from
below
the
detection
limit
of
0.05
ppb
to
26
ppb,
with
the
majority
of
the
sample
detections
being
<
1
ppb.
EFED
notes
that
3,4
DCA
was
detected
in
these
regions
year
round;
higher
concentrations
were
generally
associated
with
the
application
time
of
pesticides.
DCA
detections
in
MS,
Page
11
of
72
MO,
TN,
AR,
and
North
LA
are
likely
to
be
a
result
of
both
diuron
and
propanil
applications
for
cotton
and
rice
production,
respectively.
However
in
South
Louisiana,
there
were
only
three
samples
analyzed
for
3,4
DCA
in
the
suburban
area
of
E.
Baton
Rouge
Parish.
The
concentrations
ranged
from
0.01
0.06
ppb
in
these
three
samples
along
with
diuron
(
Walters,
2001).
Therefore,
the
presence
of
DCA
in
these
samples
is
most
likely
due
to
roadside
use
of
diuron
because
cotton
and
rice
are
not
grown
in
E.
Baton
Rouge
Parish.
Screening
models
were
used
to
determine
estimated
concentrations
of
diuron
in
surface
water.
Ground
Water
EFED
has
limited
monitoring
data
on
the
concentrations
of
diuron
in
groundwater.
Monitoring
data
for
diuron
that
are
available
for
the
states
of
California,
Florida,
Georgia,
and
Texas
showed
a
maximum
diuron
concentration
of
5.37
ppb
(
USEPA,
1992).
The
US
Geological
Survey
(
USGS)
National
Water
Quality
Assessment
Program
(
NAWQA)
analyzed
pesticide
occurrence
and
concentrations
for
major
aquifers
and
shallow
ground
water
in
agricultural
areas
(
detection
limit
=
0.05
ppb).
Analysis
of
2608
samples
(
major
aquifers
study)
showed
diuron
in
71%
of
the
samples
analyzed
with
a
maximum
concentration
of
0.34
ppb.
Maximum
diuron
concentration
in
897
samples
from
shallow
groundwater
sites
was
2.0
ppb,
with
diuron
detected
in
only
1.23%
of
samples
analyzed
(
USGS,
1998).
A
major
component
of
the
sampling
design
in
the
NAWQA
study
was
to
target
specific
watersheds
and
shallow
ground
water
areas
that
are
influenced
primarily
by
a
single
dominant
land
use(
agricultural
or
urban)
that
is
important
in
the
particular
area.
The
ground
water
data
were
primarily
collected
from
a
combination
of
production
and
monitoring
wells.
Ground
water
sites
in
the
ground
water
data
were
sampled
for
pesticides
from
a
single
snap
shot
in
time.
According
to
the
Florida
Department
of
Environmental
Protection
(
2001),
ground
water
samples
from
wells
collected
between
5/
90
and
11/
97,
showed
diuron
detections
with
concentrations
range
from
0.94
12
ppb
(
detection
limit=
0.48
ppb).
The
arithmetic
mean
concentration
was
2.44
ppb.
Well
water
samples
were
collected
from
the
following
counties:
Highlands,
Jackson,
Lake,
Orange,
and
Polk.
With
the
exception
of
the
12
ppb
sample
in
Orange
County,
the
most
of
the
detections
were
in
Highlands
County
where
citrus
is
grown.
Diuron
concentrations
in
Highlands
County
decreased
with
time
to
about
1
ppb
but
were
detected
every
year.
In
Polk
County,
diuron
concentrations
show
a
seasonal
patter,
with
highest
concentrations
in
the
spring
and
lower
concentrations
in
the
fall,
but
was
not
detected
in
all
years.
Even
though,
the
groundwater
monitoring
data
collected
by
NAWQA
are
from
sites
considered
typical
for
use
areas,
the
frequency
of
sampling
and
the
length
of
sampling
period
were
not
sufficient
temporal
and
spatial
requirements
for
regulatory
purposes.
The
SCI
GROW
model
(
Barrett,
1997)
was
used
to
estimate
potential
groundwater
concentrations.
The
modeled
GW
EEC's
from
SCI
GROW
were
consistent
with
the
State
of
Florida
Page
12
of
72
monitoring
data,
but
were
higher
than
the
other
monitoring
data.
Drinking
Water
Recommendation
For
surface
water,
EFED
recommends
to
use
the
1
in
10
year
peak
concentration
from
the
IRPC
modeling
as
the
acute
toxicity
endpoint,
the
1
in
10
year
annual
mean
concentration
as
the
chronic
non
cancer
toxicity
endpoint,
and
the
mean
of
annual
values
as
the
cancer
toxicity
endpoint.
Tier
II
surface
water
modeling
was
done
using
the
Index
Reservoir
(
IR)
and
Percent
Crop
Area
(
PCA)
modifications
for
diuron
use
on
citrus
(
Jones
et.
al,
1998,
and
Effland
et
al.,
2000).
The
modeling
results
indicate
that
diuron
has
the
potential
to
contaminate
surface
waters
used
as
a
source
of
drinking
water
by
runoff,
especially
in
areas
with
large
amounts
of
annual
rainfall.
The
maximum
diuron
estimated
environmental
concentration
was
290
ppb,
chronic
(
non
cancer)
was
67.1
ppb,
and
chronic
(
cancer)
was
45.2
ppb.
For
groundwater,
EFED
recommends
using
the
SCI
GROW
EEC's
for
both
acute
and
chronic
endpoints.
The
EEC
from
SCI
GROW
modeling
was
11.7
ppb.
Page
13
of
72
ECOLOGICAL
EFFECTS
ASSESSMENT
SUMMARY:
Seventy
ecological
toxicity
studies
were
submitted
by
the
registrant.
Forty
nine
studies
were
classified
as
acceptable
and
fulfilling
the
guideline
requirements.
Twenty
one
studies
were
classified
as
supplemental
and
provide
the
useful
information
for
an
ecological
risk
assessment.
Some
studies
were
conducted
prior
to
current
Pesticide
Assessment
Guidelines
or
failed
to
provide
critical
information
(
such
as
using
non
recommended
species
or
lacking
of
NOEC
value).
These
studies
are
considered
unfulfilled
and
must
be
repeated.
Diuron
is
sightly
toxic
to
bobwhite
quail
and
practically
nontoxic
to
mallard
duck
on
an
acute
oral
basis.
It
is
practically
nontoxic
to
bobwhite
quail
and
slightly
toxic
to
mallard
duck
on
a
subacute
dietary
basis.
Diuron
is
relative
nontoxic
to
both
honey
bees
and
laboratory
rats.
In
the
rat
chronic
study,
diuron
caused
pop
body
weight
loss.
No
avian
reproduction
study
was
submitted
by
the
registrant
and
it
is
required
because
diuron
is
persistent
in
the
environment
(
Table
2).
Table
2.
Summary
of
acute
and
chronic
terrestrial
toxicity
estimates
using
technical
diuron
Species
Acute
Toxicity
Chronic
Toxicity
Acute
LD50
(
mg/
kg)
Acute
Oral
Toxicity
(
MRID)
Subacut
e
LC50
(
ppm)
Subacute
Dietary
Toxicity
(
MRID)
NOEC/
LOE
C
(
ppm)
(
MRID)
Affected
endpoint
Northern
bobwhite
quail
Colinus
virgianus
940
Slightly
toxic
(
50150170)
>
5000
Practically
nontoxic
(
00022923)
Mallard
duck
Anas
platyrhynchous
>
2000
Practic.
nontoxic
(
00160000)
1730
Slightly
toxic
(
00022923)
Honey
bee
Apis
meliferus
145*
Practic.
nontoxic
(
00036935)
Laboratory
rat
Rattus
norvegicus
M)
5000
F)
10000
Class.
III
(
00146145)
NOEC
=
250
LOEC
=
1750
(
00146145)
Pup
body
weight
*
F
g/
bee
Diuron
is
moderately
toxic
to
the
majority
of
aquatic
animals
tested
(
including
rainbow
trout,
bluegill
sunfish,
water
flea,
striped
mullet,
sheepshead
minnow,
Eastern
oyster,
and
brown
shrimp).
However,
it
is
highly
toxic
to
cutthroat
trout
and
scuds
and
slightly
toxic
to
fathead
minnow
In
chronic
studies,
diuron
reduced
number
of
survival
(
fathead
minnow),
growth/
survival
(
sheepshead
minnow),
and
growth/
reproduction
(
mysid
shrimp).
Water
flea
and
sheepshead
chronic
studies
failed
to
provide
the
NOEC
values
requiring
the
studies
to
be
repeated
(
Table
3).
Page
14
of
72
Table
3.
Summary
of
acute
and
chronic
aquatic
toxicity
estimates
using
technical
grade
diuron
Species
Acute
Toxicity
Chronic
Toxicity
96
hr
LC50
(
ppm)
48
h
EC
50
(
ppm)
Acute
Toxicity
(
MRID)
NOEC/
LOEC
(
ppm)
Affected
Endpoint
(
MRID)
Rainbow
trout
Oncorynchus
mykiss
1.
95
Moderately
toxic
(
STODIV04)
Bluegill
sunfish
Lepomis
microchirus
2.
8
Moderately
toxic
(
40098001)
Fathead
minnows
Pimephales
promelas
14.
2
Slightly
toxic
(
00141636)
NOEC
=
0.
0264
LOEC
=
0.0618
#
of
survivor
(
00141636)
Cutthroat
trout
Oncerynchus
clarki
0.71
Highly
toxic
(
40098001)
Scud
(
Gammmarus
fasciatus)
0.16
Highly
toxic
(
40094602)
Water
flea
Daphnia
magna
1.4
Moderately
toxic
(
40094602)
NOEC
=<
0.
2
LOEC
=
0.
2
No
effect
(
STODIV05)
Striped
mullet
Mugil
cephalus
6.3
Moderately
toxic
(
40228401)
Sheepshead
minnow
Cypprinoden
varieggatus
6.7
Moderately
toxic
(
41418805)
NOEC
=
<
0.
44
LOEC
=
0.44
Reduced
growth,
survival
(
42312901)
Eastern
oyster
Crassostrea
virginica
4.9
Moderately
toxic
(
42217201)
Mysid
shrimp
Americamysis
bahia
NOEC
=
0.
27
LOEC
=
0.
56
Growth
Reproduction
Brown
shrimp
Penaeus
aztecus
>
1
Moderately
toxic
(
40228401)
Tier
II
terrestrial
plant
seedling
emergence
and
vegetative
vigor
toxicity
studies
were
conducted
by
the
registrant
with
four
species
of
monocotyledonous
plants
(
including
corn)
and
six
species
of
dicotyledonous
plants
(
including
soybean).
The
crops
selected
were
corn,
onion,
sorghum,
and
wheat
for
monocotyledonous
plants;
and
pea,
soybean,
rape,
cucumber,
sugar
beet,
and
tomato
for
dicotyledonous
plants.
The
results
showed
that
onion
and
tomato
were
most
sensitive
species
for
seedling
emergence;
and
wheat
and
tomato
were
most
sensitive
species
for
plant
vegetative
vigor,
representing
monocotyledonous
and
dicotyledonous
family,
respectively.
Terrestrial
plants
were
more
sensitive
to
vegetative
vigor
testing
and
tomato
is
more
sensitive
than
its
monocotyledonous
counterparts.
Page
15
of
72
For
Tier
II
nontarget
aquatic
plant
toxicity
testing,
the
registrant
tested
fifteen
species
of
nonvascular
plant
including
aquatic
algae
and
diatom.
However,
only
one
study
with
green
algae
(
Selenastrum
capricornutum;
EC50
=
2.4
ppb)
is
acceptable
and
the
remaining
studies
are
supplemental
(
Table
4).
Table
4.
Summary
of
nontarget
terrestrial
plant
seedling
emergence/
vegetative
vigor
toxicity
estimates
using
formulated
diuron
(
Endpoint
affected
=
Shoot
dry
weight)
Species
Seedling
emergence
toxicity
Vegetative
vigor
toxicity
Crop
Crop
EC50/
EC05
(
lbs.
ai/
A)
EC50/
EC05
(
lbs.
ai/
A)
Monocot
Onion
Wheat
0.099/
0.089
0.021/
0.002
Dicot
Tomato
Tomato
0.08
/
0.047
0.002/
0.001
AQUATIC
EXPOSURE
ASSESSMENT
Aquatic
exposure
assessment
Diuron
aquatic
EECs
were
estimated
using
EFED's
Tier
I
surface
water
model
GENEEC
II.
The
EEC
values
of
various
crops
and
durations
using
aerial
or
ground
application
rates
are
summarized
in
Table
5.
These
values
will
be
used
for
an
aquatic
risk
assessment
by
calculating
acute
and
chronic
RQ
values
for
various
aquatic
organisms.
The
values
are
conservative
high
end
EECs.
Table
5.
Diuron
EECs
for
various
crops
using
GENEEC
(
ppb)
End
uses
Aerial
Ground
Agricultural
Peak
21
d.
avg
60
d.
avg
Peak
21
d.
avg
60
d..
avg
grape
329.85
266.38
186.93
citrus
219.9
177.58
124.62
Alfalfa
116.40
94.00
65.97
109.95
88.79
62.31
Fruits
(
Peach,
Apple,
Pear)
137.44
110.99
77.89
Sugarcane
116.4
94.00
65.97
109.95
88.79
62.31
Cotton
58.2
47.00
32.98
54.97
44.40
31.15
Page
16
of
72
Non
Agricultural
Peak
21
d.
avg
60
d.
avg
Peak
21
d.
avg
60
d..
avg
Railroad
436.54
352.99
248.16
412.31
332.97
233.66
Roadside,
utilities,
irrigation,
drainage
ditch
412.31
332.97
233.66
The
Tier
II
surface
water
model
PRZM/
EXAMS
was
used
to
obtain
more
realistic
EECs
with
grape
(
CA),
citrus
(
FL)
and
apple
(
NY)
scenarios.
These
scenarios
were
chosen
to
reflect
a
wide
range
of
application
rates
and
weather
conditions.
PRZM
EXAMS
and
GENEEC2
EECs
are
listed
in
Table
6.
GENEEC's
EECs
are
generally
greater
than
those
of
PRZM/
EXAMS
and
also
depend
on
regional
vulnerability.
For
the
use
of
diuron
on
grapes
in
CA
at
9.6
lbs
ai/
A,
GENEEC's
EECs
were
5.2
8.4
times
higher
than
those
from
PRZM/
EXAMS.
For
Fl
citrus
and
NY
apples,
GENEEC
2
EEC's
were
0.95
1.6
and
1.6
2.6
times
those
for
PRZM
EXAMS,
respectively.
Table
6.
GENEEC
VS.
PRZM/
EXAMS
EEC's
FOR
DIURON
ON
VARIOUS
CROP
Crop
Scenario
Application
Rate
(
lb
ai/
acre)
Method
of
Appl.
No.
of
Appl.
EEC
(
ppm)
GENEEC
PRZM/
EXAMS
peak
21
d.
60
d.
peak
21
d.
60
d.
CA
Grape
9.6
Ground
1
0.329
0.266
0.186
0.039
0.038
0.036
FL
Citrus
6.4
Ground
1
0.219
0.177
0.125
0.138
0.133
0.130
NY
Apple
4.0
Ground
1
0.137
0.111
0.080
0.053
0.052
0.051
ECOLOGICAL
RISK
ASSESSMENT
To
evaluate
the
potential
ecological
risk
to
nontarget
organisms
from
the
use
of
diuron
products,
risk
quotients
(
RQs)
are
calculated
from
the
ratio
of
estimated
environmental
concentrations
(
EEC)
to
ecotoxicity
values.
RQs
are
then
compared
to
level
of
concern
(
LOC)
used
by
OPP
to
indicate
potential
risk
to
nontarget
organisms
and
the
need
to
consider
risk
management
action.
When
available,
field
studies
and
incident
data
are
used
to
substantiate
EFED's
concern
of
diuron's
risk
to
nontarget
organisms.
Nontarget
Terrestrial
Animals
The
estimated
environmental
concentrations
(
EEC)
values
used
for
terrestrial
exposure
are
derived
from
the
Kenaga
nomograph,
as
modified
by
Fletcher
et
al.
(
1994),
based
on
a
large
set
of
actual
field
residue
data.
The
upper
limit
values
from
the
nomograph
represent
the
95th
percentile
of
residues
from
actual
field
measurements
(
Hoerger,
1972).
The
Fletcher
et
al.
(
1994)
modification
to
the
Kenaga
nomograph
are
based
on
measured
field
residues
from
249
published
research
papers,
including
118
various
species
of
plants,
121
pesticides,
and
17
chemical
classes
.
These
modifications
represent
the
95th
percentile
of
the
expanded
data
set.
Risk
quotients
are
based
on
the
most
sensitive
LC50
and
NOAEC
for
birds
(
in
this
Page
17
of
72
instance,
mallard
ducks
and
bobwhite
quail)
and
LD50
for
mammals
(
based
on
lab
rat
studies)
as
shown
in
Table
7.
Acute,
acute
restricted
and
acute
endangered
species
LOCs
are
exceeded
for
birds
feeding
on
short
and
tall
grasses
and
broad
leaf
plant/
insects
at
the
sites
with
high
application
rates.
Their
rates
range
from
6.4
to
12
lbs
ai/
a
(
i.
e.,
at
non
agricultural,
grape
and
citrus
sites
with
one
or
two
applications
of
4.8
lbs
ai/
A)
and
calculations
based
on
maximum
EECs.
However,
RQ
values
do
not
exceeded
LOCs
if
calculations
are
based
on
average
EECs.
The
acute
endangered
species
LOC
was
exceeded
for
birds
feeding
on
every
food
items
except
seeds
based
on
maximum
EECs.
Avian
chronic
RQ's
are
not
assessed
due
to
a
lack
of
acceptable
data
(
Table
7).
Table
7.
Avian
Acute
Risk
Quotients
for
Single
and
Multiple
Application
of
Nongranular
Products
(
Broadcast)
Based
on
a
mallard
duck
LC50
of
1730
ppm.
Site/
Application
Method
App.
Rate
(
lbs
ai/
A)
(#
of
appl.)
Food
Items
Maximum
Acute
RQ
Average
Acute
RQ
Single
application
Railroad/
right
of
way
Aerial/
Ground
appl..
12
Short
grass
1.66
a
0.19
c
Tall
grass
0.76
a
0.07
Broadleaf
plants/
Insects
0.94
a
0.08
Seeds
0.10
c
0.01
Grape
/
Ground
app
9.6
Short
grass
1.33
a
0.15
c
Tall
grass
0.61
a
0.06
Broadleaf
plants/
Insects
0.75
a
0.06
Seeds
0.08
0.01
Citrus
Ground
app.
6.4
Short
grass
0.89
a
0.10
c
Tall
grass
0.41
b
0.04
Broadleaf
plants/
Insects
0.50
a
0.04
Seeds
0.06
0.00
Fruits
Ground
app.
4.0
Short
grass
0.55
a
0.06
c
Tall
grass
0.25
b
0.02
Broadleaf
plants/
Insects
0.31
0.03
Seeds
0.03
0.00
Table
7.
Avian
Acute
Risk
Quotients
for
Single
and
Multiple
Application
of
Nongranular
Products
(
Broadcast)
Based
on
a
mallard
duck
LC50
of
1730
ppm.
Site/
Application
Method
App.
Rate
(
lbs
ai/
A)
(#
of
appl.)
Food
Items
Maximum
Acute
RQ
Average
Acute
RQ
Single
application
Page
18
of
72
Alfalfa
Sugar
cane
Grass
seeds
Aerial/
Ground
appl.
3.2
Short
grass
0.44
b
0.05
Tall
grass
0.20
b
0.02
Broadleaf
plants/
Insects
0.25
b
0.02
Seeds
0.03
0.0
Cotton
Aerial/
Ground
app.
1.6
Short
grass
0.22
b
0.02
Tall
grass
0.10
0.01
Broadleaf
plants/
Insects
0.12
0.01
Seeds
0.01
0.00
a
exceeds
acute
high,
acute
restricted
and
acute
endangered
species
LOC's
b
exceeds
acute
restricted
and
acute
endangered
species
LOC's.
c
exceeds
acute
endangered
species
LOC's.
Table
7
(
cont.).
Avian
Acute
Risk
Quotients
for
Single
and
Multiple
Application
of
Nongranular
Products
(
Broadcast)
Based
on
a
mallard
duck
LC50
of
1730
ppm
Multiple
application
Site/
App.
Method
App.
Rate
(
lbs
ai/
A)
(#
of
appl.)
Food
Items
Maximum
Acute
RQ
Average
Acute
RQ
Citrus
4.8
(
2)
Short
grass
1.26
a
0.14
c
Tall
grass
0.58
a
0.05
Brad
leaf
plant
/
Insects
0.71
a
0.06
Seeds
0.08
0.01
Sugarcane
3.2
(
3)
Shortgrass
0.84
a
0.09
Tall
grass
0.39
b
0.04
Brad
leaf/
plant
insects
0.47
b
0.04
Seeds
0.05
0.00
Cotton
1.2
(
2)
Shortgrass
0.32
b
0.04
Tall
grass
0.14
0.01
Brad
leaf
plant/
Insects
0.18
0.01
Seeds
0.02
0.00
a
exceeds
acute
high,
acute
restricted
and
acute
endangered
species
LOCs.
b
exceeds
acute
restricted
and
acute
endangered
species
LOCs.
c
exceeds
acute
endangered
species
LOCs.
Page
19
of
72
Acute,
acute
restricted
and
acute
endangered
species
LOCs
was
exceeded
for
small
mammals
feeding
on
short
grass
(
Table
8).
The
majority
of
chronic
RQ
values
for
mammals
feeding
on
short
and
tall
grasses,
and
broadleaf
plants/
insects
exceeded
chronic
LOC
regardless
of
which
EECs
are
used
(
Table
9).
Page
20
of
72
Table
8.
Acute
RQ
values
for
small
(
15g),
intermediate
(
35
g)
and
large
(
1,000
g)
mammals
feeding
on
short
or
tall
grass,
broadleaf
plants/
insects,
and
seeds
exposed
to
diuron
following
single
and
multiple
applications.
Site
Appl.
rate
(
ai
lbs)
(#
of
appl)
Body
weight
(
g)
RQ
Short
Grass
RQ
Tall
Grass
RQ
Broad
leaf
Plants/
Insects
RQ
Seeds
Non
agriculture
12
(
1)
15
0.55
a
0.31
b
0.03
0.01
35
0.38
b
0.22
b
0.02
0.01
1000
0.09
c
0.05
0.01
<
0.01
Grape/
ground
9.6
(
1)
15
0.44
b
0.25
b
0.03
<
0.01
35
0.31
b
0.17
c
0.02
<
0.01
1000
0.07
c
0.04
<
0.01
<
0.01
Citrus/
ground
6.4
(
1)
15
0.29
b
0.17
c
0.02
<
0.01
35
0.20
b
0.11
c
0.01
<
0.01
1000
0.05
0.03
<
0.01
<
0.01
Fruits/
ground
4.0
(
1)
15
0.18
c
0.10
c
0.01
<
0.01
35
0.13
c
0.07
0.01
<
0.01
1000
0.03
0.02
<
0.01
<
0.01
Alfalfa/
sugarcane/
gras
s
seeds
3.2
(
1)
15
0.15
c
0.08
0.01
<
0.01
35
0.10
c
0.06
0.01
<
0.01
1000
0.02
0.01
<
0.01
<
0.01
Cotton
/
aerial
1.6
(
1)
15
0.07
0.04
<
0.01
<
0.01
35
0.05
0.03
<
0.01
<
0.01
1000
0.01
0.01
<
0.01
<
0.01
Citrus/
Ground
4.8
(
2)
15
0.44
b
0.25
b
0.03
<
0.01
35
0.31
b
0.17
c
0.02
<
0.01
1000
0.07
0.04
<
0.01
<
0.01
Sugarcane/
aerial
3.2
(
3)
15
0.44
b
0.25
b
0.03
<
0.01
35
0.31
b
0.17
c
0.02
<
0.01
1000
0.07
0.04
<
0.01
<
0.01
Cotton/
aerial
1.2
(
2)
15
0.11
c
0.06
c
0.01
<
0.01
35
0.08
0.04
0.00
<
0.01
1000
0.02
0.01
<
0.00
a
exceeds
acute
high,
acute
restricted
and
acute
endangered
species
LOCs
b
exceeds
acute
restricted
and
acute
endangered
species
LOCs.
c
exceeds
acute
endangered
species
LOCs.
Page
21
of
72
Page
22
of
72
Table
9.
Chronic
RQ
values
for
mammals
feeding
on
short
grass,
tall
grass,
broadleaf
plants/
insects,
and
seeds
exposed
to
diuron
following
multiple
applications.
Site
Appl.
rate
(
ai
lbs)
(#
of
appl)
Source
of
EEC
RQ
Short
Grass
RQ
Tall
Grass
RQ
Broad
leaf
Plants/
Insects
RQ
Seeds
Citrus/
Ground
4.8
(
2)
Max.
Chronic
1/
9.22
d
4.22
d
5.18
d
0.58
Max.
Chronic
2/
8.73
d
4.00
d
4.91
d
0.55
Average
chronic
2/
3.09
d
1.31
d
1.64
d
0.25
Sugarcane/
aerial
3.2
(
3)
Max.
Chronic
1/
9.22
d
4.22
d
5.18
d
0.58
Max.
Chronic
2/
5.82
d
2.67
d
3.27
d
0.36
Average
chronic
2/
2.06
d
0.87
1.09
d
0.17
Cotton/
aerial
1.2
(
2)
Max.
Chronic
1/
2.11
d
0.97
1.19
d
0.13
Max.
Chronic
2/
2.18
d
1.00
d
1.23
d
0.14
Average
chronic
2/
0.77
0.33
0.41
0.06
1/
From
Hoerger
&
Kenaga
nomograph
2/
Estimation
of
maximum
chronic
value
using
Fate
model
d
exceeds
chronic
LOCs
Nontarget
Aquatic
Animals
For
freshwater
fish
exposed
to
EECs
based
on
GENEEC,
the
proposed
major
uses
of
diuron
(
except
non
agricultural
uses)
will
not
exceed
acute
LOCs,
but
will
exceed
restricted
use
and
endangered
species
LOCs.
However,
all
freshwater
fish
chronic
RQ
values
(
except
on
cotton
with
two
applications
of
1.2
lbs
ai/
A)
exceed
both
endangered
and
non
endangered
species
chronic
level
of
concern.
For
freshwater
invertebrates,
all
acute
RQ
values
exceeded
LOCs
for
both
endangered
and
non
endangered
species
(
except
cotton
and
sugarcane
uses).
However,
chronic
freshwater
invertebrate
RQs
were
exceeded
for
both
endangered
and
non
endangered
species
only
with
non
agricultural,
grape
and
citrus
uses
between
4.8
and
12
lbs
ai/
A.
EFED
also
calculated
risk
quotients
using
the
toxicity
levels
of
concern
and
EEC's
from
the
Tier
II
surface
water
runoff
model
PRZM/
EXAMS
for
grape,
citrus,
and
apple
sites.
For
freshwater
fish,
the
RQ
values
ranged
from
0.19
to
0.46
and
1.36
to
4.92
for
acute
and
chronic
risks,
respectively.
For
freshwater
invertebrates,
they
were
0.24
to
0.86
and
0.19
to
0.67
for
acute
and
chronic
effects,
respectively.
Among
these
high
rate
use
sites,
the
RQ's
that
exceeded
the
LOC's
for
freshwater
invertebrates
was
reduced
from
3
to
1
and
from
1
to
0
for
acute
and
chronic
effects,
respectively.
There
was
no
change
in
the
number
of
exceedences
of
LOC's
for
freshwater
fish
chronic
effects
(
Table
10).
Page
23
of
72
Table
10.
Acute
and
Chronic
Risk
Quotients
for
Freshwater
Fish
and
Invertebrate
Exposed
to
Diuron
Crop/
Appl
method
Application
rate,
lbs
(#
of
appl.
)
EECs
(
ppm)
Peak
21
day
average
60
day
average
Acute
Risk
Quotients
Chronic
Risk
Quotients
Freshwater
Fish
Cutthroat
trout
LC50
=
0.71
ppm.
Freshwater
Invert.
Scuds
LC50
=
0.16
ppm
Freshwater
Fish
Fathead
minnow
NOEC
=
0.0264
Freshwater
Invert.
Water
flea
NOEC
=
0.2
ppm
Non
agriculture
12
(
1)
0.
412
0.
353
0.234
0.
58
a
2.
58
a
9.
00
d
1.77
*
d
Grape/
ground
9.6
(
1)
0.
330
(
0.039)
1/
0.
266
(
0.038)
1/
0.187
(
0.036)
1/
0.46
b
(
0.05)
2/
2.
06
a
(
0.24)
2/
7.
19
d
(
1.36
d
)
2/
1.33
*
d
(
0.19)
2/
Citrus/
ground
6.4
(
1)
0.
220
(
0.138)
1/
0.178
(
0.133)
1/
0.125
(
0.130)
1/
0.31
b
(
0.19)
2/
1.38
a
(
0.86
a
)
2/
4.81
d
(
4.92
d
)
2/
0.89
(
0.67)
2/
Fruits/
ground
4.0
(
1)
0.137
(
0.053)
1/
0.094
(
0.052)
1/
0.078
(
0.051)
1/
0.19
b
(
0.07)
2/
0.86
a
(
0.33)
2/
3.00
d
(
1.93
d
)
2/
0.47
(
0.26)
Alfalfa/
sugarcane/
gr
ass
seeds
3.2
(
1)
0116
0.111
0.066
0.16
b
0.73
a
2.54
d
0.56
Cotton
/
aerial
1.6
(
1)
0.058
0.047
0.033
0.08
c
0.36
b
1.27
d
0.24
Citrus/
Ground
4.8
(
2)
0.091
0.247
0.052
0.13
b
0.57
a
2.00
d
1.24
Sugarcane/
aerial
3.2
(
3)
0.061
0.163
0.035
0.09
c
0.38
b
1.35
*
d
0.82
Cotton/
aerial
1.2
(
2)
0.022
0.061
0.031
0.03
0.14
b
0.50
0.31
a
exceeds
acute
high,
acute
restricted
and
acute
endangered
species
LOCs.
1/
EEC
based
on
PRZM/
EXAMS
run.
2/
RQ
based
on
PRZM/
EXAMS
run.
b
exceeds
acute
restricted
and
acute
endangered
species
LOCs.
Page
24
of
72
c
exceeds
acute
endangered
species
LOCs.
d
exceeds
chronic
LOCs.
Neither
acute
nor
chronic
RQ
s
for
estuarine/
marine
animals
exceeds
acute
or
chronic
level
of
concerns
except
for
chronic
RQ
of
invertebrates
at
non
agricultural
sites.
However,
restricted
use
or
endangered
species
LOC's
were
exceeded
for
esturarine
invertebrates
and
endangered
species
LOC's
only
for
estuarine
fish
with
both
non
agricultural
and
grape
uses
(
Table
11).
Table
11.
Acute
and
Chronic
Risk
Quotients
for
Estuarine/
Marine
Fish
and
Invertebrate
Exposed
to
Diuron
Crop/
Appl
method
Application
rate
lbs
(#
of
appl.
)
EECs
(
ppm)
Peak
21
day
average
60
day
average
Acute
Risk
Quotients
Chronic
Risk
Quotients
Estuarine
Fish
Striped
mullet
LC50
=
6.
3
ppm.
Estuarine
Invertebrate
Brown
shrimp
LC50
=
6.
3
ppm
Estuarine
Fish
Sheepshead
minnow
NOEC
=
0.44
Estuarine
Invertebrate
Mysid
shrimp
NOEC
=
0.27
ppm
Non
agriculture
12
(
1)
0.
412
0.
353
0.234
0.
07
c
0.412
b
0.53
1.31a
Grape/
ground
9.6
(
1)
0.330
(
0.039)
1/
0.
266
(
0.038)
1/
0.187
(
0.036)
1/
0.05
c
(
0.006)
0.330
b
(
0.039)
0.43
(
0.08)
0.99
(
0.14)
Citrus/
ground
6.4
(
1)
0.
220
(
0.138)
1/
0.178
(
0.133)
1/
0.125
(
0.130)
1/
0.03
(
0.022)
0.220
b
(
0.138)
0.28
(
0.30)
0.06
(
0.49)
Fruits/
ground
4.0
(
1)
0.137
(
0.053)
1/
0.094
(
0.052)
1/
0.078
(
0.051)
1/
0.02
(
0.008)
0.137
b
(
0.053)
0.18
(
0.12)
0.35
(
0.15)
Alfalfa/
sugarcane/
grass
seeds
3.2
(
1)
0116
0.111
0.066
0.02
0.116
b
0.15
0.41
Cotton
/
aerial
1.6
(
1)
0.058
0.047
0.033
0.01
0.058
c
0.08
0.17
Citrus/
Ground
4.8
(
2)
0.091
0.247
0.052
0.01
0.091
c
0.12
0.91
Page
25
of
72
Sugarcane/
aerial
3.2
(
3)
0.061
0.163
0.035
0.01
0.061
c
0.08
0.6
Cotton/
aerial
1.2
(
2)
0.022
0.061
0.031
0.01
0.
023
0.03
0.23
a
exceeds
acute
high,
acute
restricted
and
acute
endangered
species
LOCs
1/
EEC
based
on
PRZM/
EXAMS
run.
b
exceeds
acute
restricted
and
acute
endangered
species
LOCs.
c
exceeds
acute
endangered
species
LOCs
d
exceeds
chronic
LOCs.
Page
26
of
72
Nontarget
Plants
Table
12.
Seedlings
Emergence
and
Vegetative
vigor
Risk
Quotients
from
a
Single
Application
for
Terrestrial
Plants
in
Dry
and
Semi
Aquatic
Area
Based
on
a
Tomato
Emergence
EC25
of
0.08
lbs/
A
and
a
Tomato
Vegetative
Vigor
EC05
of
0.002
lbs
ai/
A.
Site
Acute
Risk
Acute
Endangered
Species
Risk
App.
Rate
(#
ai/
A)
Emergence
RQ
Dry
Area
1/
Emergence
RQ
Semi
aquatic
2/
Vegetative
Vigor
RQ
Dry
+
Semi
aquatic3/
Emergence
RQ
Dry
Area
4/
Emergence
RQ
Semi
aquatic
5/
Vegetative
vigor
RQ
Dry
+
Semi
aquatic
6
Ground
Application
Nonagriculture
12
9.00
a
76.50
a
5.00
a
36.00
a
306.00
a
20.00
a
Grape
9.6
7.25
a
61.25
a
5.00
a
29.00
a
245.00
a
20.00
a
Citrus
6.4
4.75
a
40.75
a
5.00
a
19.00
a
163.00
a
20.00
a
Alfalfa/
Sugarc
ane/
Grass
seeds
3.2
2.38
a
20.38
a
5.00
a
9.50
a
81.50
a
20.00
a
Cotton
1.6
1.25
a
10.25
a
5.00
a
5.00
a
41.00
a
20.00
a
Aerial
Application
Nonagriculture
12
12.00
a
52.50
a
25.00
a
48.00
a
210.00
a
100.00
a
Citrus
9.6
9.63
a
42.25
a
25.00
a
38.50
a
169.00
a
100.00
a
Alfalfa/
Sugarcane
3.2
3.25
a
14.50
a
25.00
a
13.00
a
58.00
a
100.00
a
Cotton
1.6
1.63
a
7.25
a
25.00
a
6.50
a
29.00
a
100.00
a
1/
(
Dry
area
EEC)
÷
(
Emergency
EC25)
2/
(
Semi
aq
area
EEC)
÷
(
Emergency
EC25
)
3/
(
Dry
+
Semi
aq
area
EEC)
÷
(
Vegetative
vigor
EC25)
4/
(
Dry
area
EEC)
÷
(
Emergency
EC05)
5/
(
Semi
aq
area
EEC)
÷
(
Emergency
EC05
)
6/
(
Dry
+
Semi
aq
area
EEC)
÷
(
Vegetative
vigor
EC05)
a
exceeds
acute
high,
acute
restricted
and
acute
endangered
species
LOC's
Runoff
RQs(
from
both
dry
and
semi
aquatic
areas)
and
drift
RQs
(
from
both
areas),
based
on
the
most
sensitive
monocot
and
dicot
EC25
and
EC05,
exceeded
acute
and
acute
endangered
species
LOCs.
The
RQs
ranged
from
1.25
to
76.5
for
acute
risk
and
5
to
306
for
risk
to
endangered
species
(
Table
12).
Page
27
of
72
Table
13.
Acute
Risk
Quotients
for
Aquatic
Plants
based
upon
a
nonvascular
plant
(
Skeletonema
costatum)
EC50
of
0.0024
ppm
ai.
Site/
Application
Method/
Rate
of
Application
(
lbs
ai/
A)
EEC
(
ppm)
Non
target
plant
RQ
(
EEC/
EC
50)
Railroad/
right
of
way
aerial/
ground
12
(
1)
0.412
171.67
a
Grape/
Ground
9.6
(
1)
0.330
137.50
a
Citrus/
Ground
6.4
(
1)
0.220
91.67
a
Fruits/
ground
4.0
(
1)
0.137
57.08
a
Alfalfa/
sugarcane/
grass
seeds/
sugarcane
aerial
3.2
(
1)
0.116
48.33
a
Cotton/
aerial
1.6
(
1)
0.058
24.17
a
Citrus/
Ground
4.8
(
2)
0.091
37.92
a
Sugarcane/
aerial
3.2
(
3)
0.061
25.42
a
Cotton/
aerial
1.2
(
2)
0.023
9.58
a
a
exceeds
acute
high
LOCs
Fifteen
aquatic
plant
Tier
II
toxicity
studies
were
submitted
by
the
registrant.
However,
14
studies
used
non
standard
plant
species.
EFED's
standard
procedure
is
to
conduct
an
aquatic
plant
risk
assessment
using
the
most
sensitive
specie
of
the
five
required
species.
However,
only
the
green
algae
(
Skeletonema
costatum)
EC50
study
is
core.
The
green
algae
study
is
being
used
for
aquatic
plant
risk
assessment
because
it
is
the
only
standard
specie,
and
was
the
most
sensitive
specie
of
the
15
tested
plants.
Due
to
lack
of
data,
EFED
does
not
know
if
green
algae
will
be
the
most
sensitive
aquatic
plant
specie.
Therefore,
the
EC50
value
for
the
most
sensitive
nonvascular
species
is
still
undetermined.
The
acute
EC50
study
for
the
vascular
aquatic
plant
duckweed,
remains
a
data
gap.
The
results
of
green
algae
Tier
II
toxicity
study
shows
that
its
RQs
exceeded
acute
LOCs
for
all
sites.
Their
RQ
values
range
from
9.58
to
171.67
(
Table
13).
ENDANGERED
SPECIES
Endangered
species
LOCs
for
diuron
are
exceeded
for
terrestrial
plants
for
all
uses,
herbivorous
mammals,
and
herbivorous
and
insectivorous
birds
from
all
uses;
freshwater
fish
and
crustaceans
from
all
uses
but
cotton;
and
mollusks
and
estuarine
fish
from
the
uses
on
grapes
and
non
agricultural
sites.
The
Agency
consulted
with
the
US
Fish
and
Wildlife
Service
(
FWS
or
the
Service)
on
the
agricultural
uses
of
diuron
in
the
"
reinitiation"
of
the
cluster
assessments
in
1988.
The
resulting
1989
opinion
found
jeopardy
to
the
Wyoming
toad
(
extirpated
in
the
wild
except
on
FWS
refuges).
The
Service
proposed
a
Reasonable
and
Prudent
Alternative
(
RPA)
(
no
spray
zone
within
100
yards
of
occupied
habitat
for
ground
applications
and
1/
4
mile
for
aerial
application)
to
avoid
the
likelihood
of
jeopardizing
the
continued
Page
28
of
72
existence
of
this
species.
In
addition,
the
Service
had
Reasonable
and
Prudent
Measures
(
RPM)
to
reduce
incidental
take
of
20
fish
and
two
aquatic
invertebrate
species.
The
details
of
the
RPM
recommendations
are
provided
in
the
FWS
1989
biological
opinion.
Many
additional
species,
especially
aquatic
species,
have
been
federally
listed
as
endangered/
threatened
since
the
biological
opinion
of
1989
was
written,
and
determination
of
potential
effect
to
these
species
has
not
been
assessed
for
diuron.
In
addition,
endangered
plants,
birds
and
mammals
were
not
considered
in
the
1989
opinion
and
need
to
be
addressed.
The
biological
opinion
only
covered
the
crops
applications
of
diuron.
The
nonagricultural
uses
such
as
rights
of
ways,
ditch
banks,
railroads
were
not
addressed.
As
the
highest
application
rates
occur
on
these
non
agricultural
sites,
these
uses
also
need
to
be
considered
in
any
reinitiation.
Finally,
not
only
are
more
refined
methods
to
define
ecological
risks
of
pesticides
being
used
but
also
new
data,
such
as
that
for
spray
drift,
are
now
available
that
did
not
exist
in
1989.
The
RPMs
in
the
1989
opinion
may
need
to
be
reassessed
and
modified
based
on
these
new
approaches.
The
Agency
is
currently
engaged
in
a
Proactive
Conservation
Review
with
FWS
and
the
National
Marine
Fisheries
Service
under
section
7(
a)(
1)
of
the
Endangered
Species
Act
to
clarify
and
develop
consistent
processes
for
endangered
species
risk
assessments
and
consultations.
Subsequent
to
the
completion
of
this
process,
the
Agency
will
reassess
both
those
species
listed
since
the
completion
of
the
biological
opinion
and
those
not
considered
in
the
opinion.
The
nonagricultural
uses
will
also
be
considered
at
this
time.
The
Agency
will
also
consider
regulatory
changes
recommended
in
the
RED
when
we
undertake
this
reassessment.
The
Agency
has
developed
the
Endangered
Species
Protection
Program
to
identify
pesticides
whose
use
may
cause
adverse
impacts
on
endangered
and
threatened
species,
and
to
implement
mitigation
measures
that
address
these
impacts.
The
Endangered
Species
Act
requires
federal
agencies
to
ensure
that
their
actions
are
not
likely
to
jeopardize
listed
species
or
adversely
modify
designated
critical
habitat.
To
analyze
the
potential
of
registered
pesticide
uses
to
affect
any
particular
species,
EPA
puts
basic
toxicity
and
exposure
data
developed
for
REDs
into
context
for
individual
listed
species
and
their
locations
by
evaluating
important
ecological
parameters,
pesticide
use
information,
the
geographic
relationship
between
specific
pesticides
uses
and
species
locations,
and
biological
requirements
and
behavioral
aspects
of
the
particular
species.
This
analysis
will
include
consideration
of
the
regulatory
changes
recommended
in
this
RED.
A
determination
that
there
is
a
likelihood
of
potential
impact
to
a
listed
species
may
result
in
limitations
on
use
of
the
pesticide,
other
measures
to
mitigate
any
potential
impact,
or
consultations
with
the
Fish
and
Wildlife
Service
and/
or
the
National
Marine
Fisheries
Service
as
necessary.
At
present,
the
program
is
being
implemented
on
an
interim
basis
as
described
in
a
Federal
Register
notice
(
54
FR
27984
28008,
July
3,
1989).
A
final
program,
which
may
be
altered
from
the
interim
program,
will
be
proposed
in
a
Federal
Register
notice
scheduled
for
publication
in
autumn
of
2001.
Page
29
of
72
Page
30
of
72
ENVIRONMENTAL
MODELING
AND
MONITORING
REFERENCES
C
Barrett,
M.,
1997,
Proposal
For
a
Method
to
Determine
Screening
Concentration
Estimates
for
Drinking
Water
Derived
from
Groundwater
Studies,
EFED/
OPP.
C
Burns,
L.
A.
March
1997.
Exposure
Analysis
Modeling
System
(
EXAMS
II)
Users
Guide
for
Version
2.97.5,
Environmental
Research
Laboratory,
Office
of
Research
and
Development,
U.
S.
Environmental
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Athens,
GA.
C
Carsel,
R.
F.,
J.
C.
Imhoff,
P.
R.
Hummel,
J.
M.
Cheplick
and
J.
S.
Donigian,
Jr.
1997.
PRZM
3,
A
Model
for
Predicting
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and
Nitrogen
Fate
in
Crop
Root
and
Unsaturated
Soil
Zones:
Users
Manual
for
Release
3.0;
Environmental
Research
Laboratory,
Office
of
Research
and
Development,
U.
S.
Environmental
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Athens,
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C
Effland,
W.,
N.
Thurman,
I.
Kennedy,
R.
D.
Jones,
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Breithaupt,
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Lin,
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Carleton,
L.
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R.
Parker,
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Matzner.
2000.
"
Guidance
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use
of
the
index
Reservoir
and
Percent
Crop
Area
Factor
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drinking
water
exposure
assessment
s.
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of
Pesticide
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C
Florida
Department
of
Environmental
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Personal
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Bryan
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C
Harris,
Jennifer.
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DCA.
xls"
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to
James
Breithaupt
of
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EFED
on
5/
21/
2001
in
Response
to
Data
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C
Jones,
R.
D.,
S.
W.
Abel,
W.
Effland,
R.
Matzner,
and
R.
Parker.
1998.
"
An
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for
Use
in
Assessing
Drinking
Water
Exposures.
Chapter
IV
in
Proposed
Methods
for
Basin
Scale
Estimation
of
Pesticide
Concentrations
in
Flowing
Water
and
Reservoirs
for
Tolerance
Reassessment.,
presented
to
the
FIFRA
Science
Advisory
Panel,
July
1998.
http://
www.
epa.
gov/
pesticides/
SAP/
1998/
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C
Powell,
S.,
R.
Neal,
and
J.
Leyva.
1996.
Runoff
and
Leaching
of
Simazine
and
Diuron
used
on
Highway
Rights
of
Way.
CAL
DPR
Report
No.
EH
96
03.
[
Online].
Available
at
www.
cdpr.
ca.
ca.
gov/
empm/
pubs/
chapreps/
e9603.
htm.
C
Thurman,
E.
M.,
K.
C.
Bastian,
and
T.
Mollhagen.
Occurrence
of
cotton
herbicides
and
insecticides
in
Playa
lakes
of
the
high
plains
of
western
Texas.
[
Online].
Available
at
http://
toxics.
usgs.
gov/
pubs/
wri99
4018/
Volume2/
sectionC/
2403Thurman/
pdf/
2403_
Thurman.
pdf,
May,
2001).
C
USEPA.
1992.
Pesticides
in
Ground
Water
Database
A
compilation
of
Monitoring
Studies:
1971
Page
31
of
72
1991.
Office
of
Prevention,
Pesticides,
and
Toxic
Substances,
EPA
734
12
92
001.
C
USGS.
1998.
National
Water
Quality
Assessment
(
NWQA),
Pesticides
National
Synthesis
Project
[
Online]
at
(
http://
ca.
water.
usgs.
gov/
pnsp/
streamsum/
streamT1.
html).
C
USGS.
1998.
National
Water
Quality
Assessment
(
NAWQA),
Pesticides
National
Synthesis
Project,
[
Online]
at
http://
ca.
water.
usgs.
gov/
pnsp/
allsum/#
over.
C
Walters,
D.
2001.
USGS
Spreadsheet
"
Breithaupt.
xls"
sent
to
James
Breithaupt
of
OPP/
EFED
on
5/
23/
2001
in
Response
to
Data
Request.
Page
32
of
72
APPENDIX
1
SUMMARY
OF
SUBMITTED
ENVIRONMENTAL
FATE
STUDIES
Degradation
Satisfied:
161
1
Hydrolysis
;
MRID#
41418804.
Diuron
was
stable
to
hydrolysis
in
buffered,
sterilized
solutions
at
pH
5,
7,
and
9
after
30
days
at
25
±
1
oC
in
the
dark.
The
very
small
amount
of
degradation
that
occurred
(
less
than
4%
of
applied
radioactivity)
yielded
extremely
extrapolated
half
lives
of
>
500
days
in
each
test
solution.
A
minor
degradate
(
0.5%
of
applied
radioactivity)
in
all
test
solutions
was
identified
as
3,4
dichloroaniline
(
3,4
DCA).
161
2
Photodegradation
in
Water;
MRID#
41418805.
Diuron
photodegrades
in
water
with
a
half
life
of
9
days
(
about
43
days
under
natural
sunlight)
after
exposure
for
15
days
(
continuos
irradiation;
equivalent
to
70
days
of
discontinuous
irradiation
[
12
hours
light
and
12
hours
dark]
to
Xenon
light.
Degradates
were
CO2
and
at
least
13
minor
(
each
is
<
9%
of
applied
radioactivity)
polar
products.
There
was
no
degradation
in
the
dark
controls.
161
3
Photodegradation
in
Soil;
MRID#
41719302.
Uniformly
ring
labeled
14C
diuron
degraded
with
a
calculated
half
life
of
173
days
on
silt
loam
soil
irradiated
on
a
12
hour
photoperiod
with
a
Xenon
arc
lamp
at
25
oC
for
30
days.
The
major
degradate
was
N'(
3,4
dichlorophenyl)
N
methylurea
(
DCPMU).
The
minor
degradates
demethylated
DCPMU
(
DCPU),
dichloroaniline
(
DCA),
and
3,3',
4,4'
tetrachlorobenzene
(
TCAB)
were
also
identified.
Diuron
did
not
degrade
in
the
dark
control
samples.
Metabolism
162
1
Aerobic
Soil
Metabolism;
MRID#
4179303.
14C
Diuron
degraded
with
a
half
life
of
372
days
in
a
non
sterilized
aerobic
silt
loam
soil
that
was
incubated
in
darkness
at
25
oC
for
one
year.
The
half
life
in
the
sterilized
soil
was
1920
days.
The
degradates
identified
were
N'(
3,4
dichlorophenyl)
N
methylurea
(
DCPMU)
and
N'(
3,4
dichlorophenyl)
urea
(
DCPU).
DCPMU
reached
20.9
22.5
%
of
the
applied
by
the
end
of
the
study
(
365
days)
and
was
the
only
significant
degradate.
14CO2
comprised
3.36%
of
the
applied
radioactivity
by
365
days
posttreatment.
162
2
Anaerobic
Soil
Metabolism;
MRID#
41418806.
14C
Diuron
(
at
8.27
ppm
equivalent
to
maximum
field
application
rate
of
10
lb
ai/
A)
degraded
very
slowly
under
anaerobic
conditions
(
t1/
2
=
1000
days)
in
Page
33
of
72
silt
loam
soil.
The
only
degradate
identified
was
DCPMU,
which
accounted
for
a
maximum
of
10.3%
of
applied
radioactivity
after
45
days
of
anaerobic
incubation;
diuron
was
89.7%
at
this
time.
The
half
life
under
aerobic
conditions
was
not
calculated,
but
DCPMU
was
present
at
13%
after
30
days;
the
parent
was
87%
at
this
time.
162
3
Anaerobic
Aquatic
Metabolism;
MRID#
44221001.
Diuron
degraded
with
a
calculated
half
life
of
5
days
in
a
clay
loam
sediment:
water
system
that
was
incubated
under
anaerobic
conditions
at
25
+
2
oC
in
darkness
for
up
to
370
days.
Three
degradates
were
identified:
N'(
3
chlorophenyl)
N,
N
dimethylurea
(
mCPDMU);
1,1
dimethyl
3
phenylurea
(
PDMU);
and
N(
3
chlorophenyl)
N'
methylurea
(
mCPMU).
Parent
diuron
was
mainly
associated
with
the
soil,
and
the
predominant
degradate
mCPDMU
was
mainly
associated
with
the
aqueous
phase.
PDMU
and
mCPMU
were
minor
degradates
162
4
Aerobic
Aquatic
Metabolism;
MRID#
44221002.
Diuron
degraded
with
a
half
life
of
33
days
in
a
an
aerobic
non
sterile
clay
loam
sediment:
water
system
that
was
incubated
at
25
oC
in
darkness
for
up
to
30
days.
The
predominant
degradate
mCPDMU
reached
25
%
of
the
applied
dose
by
the
end
of
the
study,
and
was
evenly
distributed
between
the
soil
and
aqueous
phase.
The
identified
minor
degradates
were
DCPMU
and
demethylated
mCPDMU
(
CPMU),
and
were
primarily
associated
with
the
soil.
164
1
Terrestrial
Field
Dissipation;
MRID#
44654001,
44865001.
Diuron
was
applied
in
a
single
application
at
12
lb
ai/
acre
to
bare
ground
plots
in
FL,
MS,
and
CA
with
sand,
silt
loam,
and
silty
clay
loam
soils,
respectively.
The
reviewer
calculated
half
lives
were
73,
139,
and
133
days,
respectively.
The
major
degradate,
DCPMU,
dissipated
in
the
same
plots
with
reviewer
calculated
half
lives
of
217,
1733,
and
630
days,
respectively.
164
2
Aquatic
Field
Dissipation;
MRID#
43762901.
Diuron
(
Karmex
®
DF,
80%
a.
i.),
broadcast
applied
once
at
a
nominal
application
rate
of
12.0
lb
a.
i./
A
onto
the
bare
ground
slope
and
berm
of
a
channel
plot
of
clay
soil
in
California,
dissipated
with
reviewer
calculated
half
life
of
177
days
(
r2
=
0.38).
The
major
degradate
DCPMU
was
detected
in
the
0
to
15
cm
depth
of
the
berm
soil
at
0.049
ppm
immediately
following
application.
Aquatic
Field
Dissipation;
MRID#
43978901.
Diuron
(
Karmex
®
DF,
80%
a.
i.),
broadcast
applied
once
at
a
nominal
application
rate
of
12.0
lb.
a.
i./
A
onto
the
bare
ground
berm
and
slope
of
a
drainage
ditch
plot
of
silt
loam
soil,
dissipated
with
a
reviewer
calculated
half
life
of
115
days
(
r2
=
0.5;
slope
and
berm
soil
combined)
in
berm
and
slope
soil.
In
the
0
to
15
cm
soil
berm
depth,
the
major
degradate
DCPMU
was
detected
with
a
maximum
of
0.45
ppm
at
91
days.
Mobility
Page
34
of
72
163
1
Leaching/
Adsorption/
Desorption;
MRID#
(
MRID
No.
444490501).
Uniformly
phenyl
ring
labeled
[
14C]
diuron,
at
nominal
concentrations
of
0.1,
0.5,
1.0
and
5.0
F
g/
mL,
was
studied
in
Chino
loam,
Barclay
silty
clay
loam,
and
Keyport
silt
loam
soil:
solution
slurries
that
were
equilibrated
for
>
12
hours
at
22
±
3
E
C.
Freundlich
Kads
values
were
14
for
the
loam
soil
(
1.4%
o.
m.),
7.9
for
the
silty
clay
loam
soil,
and
28
for
the
silt
loam
soil
(
7.7%
o.
m.);
corresponding
Koc
values
were
1666,
468,
and
626
mL/
g.
Material
balances
were
not
reported
for
samples
utilized
in
the
definitive
study.
This
study
could
be
ungraded
upon
the
submission
of
material
balances
information.
APPENDIX
2
SCI
GROW,
GENEEC2,
and
PRZM
EXAMS
Inputs
and
Outputs
GENEEC
FOR
ECOLOGICAL
EFFECTS
AND
DRINKING
WATER
ASSESSMENTS
Background
Information
on
SCI
GROW
The
Environmental
Fate
and
Effects
Division
of
USEPA's
Office
of
Pesticide
Programs
(
OPP)
uses
a
tiered
system
of
pesticide
exposure
modeling
to
assess
risk
of
a
pesticide
product
to
the
environment.
This
tiered
system
is
designed
to
minimize
the
amount
of
analysis
which
is
required
to
register
any
given
chemical.
Each
tier
is
designed
to
screen
out
pesticides
by
requiring
higher,
more
complex
levels
of
investigation
only
for
those
that
have
not
passed
the
next
lower
tier.
Each
tier
screens
out
a
percentage
of
pesticides
from
having
to
undergo
a
more
rigorous
pre
registration
review.
SCI
GROW,
the
first
tier
is
designed
as
a
coarse
screen
and
estimates
expected
concentrations
from
a
few
basic
chemical
parameters
and
pesticide
label
application
information.
Tier
1
is
used
to
screen
chemicals
to
determine
which
ones
potentially
pose
sufficient
risk
to
warrant
higher
level
assessment.
The
Tier
1
model
described
here,
the
Screening
Concentration
in
Ground
Water
Program
(
SCI
GROW),
uses
a
regression
model
that
uses
a
candidate
chemical's
soil/
water
partition
coefficient
and
degradation
half
life
values
to
estimate
groundwater
concentrations
arising
from
labeled
uses
at
a
highly
vulnerable
agricultural
site.
The
program
assumes
pesticide
application
at
the
maximum
label
rate
to
a
field
that
is
highly
vulnerable
due
to
a
rapidly
permeable
soil
overlying
shallow
groundwater.
SCI
GROW
MODEL
INPUT
PARAMETERS
Page
35
of
72
Parameter
calculations/
value
source
application
rate
(
lb
ai/
acre)
9.6
label
(
EPA
Reg.
No.
1812
362).
interval
between
application.
(
day)
N/
A
label
(
EPA
Reg.
No.
1812
362).
Max
No.
application
1
label
(
EPA
Reg.
No.
1812
362).
Koc
(
mL/
g)
lowest
in
non
sand
(
468)
MRID#
44490501;
Input
parameters
guideline*
soil
aerobic
met.
t1/
2
(
d)
372
MRID#
41719303;
Input
parameters
guideline
*:
Guidance
for
Chemistry
and
Management
Practice
Input
Parameters
For
Use
in
Modeling
the
Environmental
Fate
and
Transport
of
Pesticide.
USEPA/
OPP/
EFED.
Version
2.
Nov,
7,
2000.
SCI
GROW
MODEL
OUTPUT
RUN
No.
1
FOR
diuron
INPUT
VALUES
APPL
(#/
AC)
APPL.
URATE
SOIL
SOIL
AEROBIC
RATE
NO.
(#/
AC/
YR)
KOC
METABOLISM
(
DAYS)
9.600
1
9.600
468.0
372.0
GROUND
WATER
SCREENING
CONCENTRATIONS
IN
PPB
6.521987
A=
367.000
B=
473.000
C=
2.565
D=
2.675
RILP=
3.399
F=
.
168
G=
.679
URATE=
9.600
GWSC=
6.521987
Background
Information
on
GENEEC2
GENEEC
Version
2.0
is
an
update
of
GENEEC
Version
1.2
(
Parker
et.
al.,
1995)
which
was
issued
by
the
USEPA
Office
of
Pesticide
Programs
(
OPP)
Environmental
Fate
and
Effects
Division
(
EFED)
in
May
1995
for
use
in
tier
1,
screening
level
pesticide
aquatic
ecological
risk
assessments.
Version
2
was
developed
in
response
to
suggestions
by
users
for
improvements,
by
the
desire
to
stay
current
with
the
newer
versions
of
the
PRZM
(
Carousel,
1997)
and
EXAMS
(
Burns,
2000)
programs
upon
which
GENEEC
is
based
and
by
availability
of
much
improved
data
on
spray
drift
and
quantitative
methods
of
estimation
of
offsite
spray
drift
developed
by
the
Spray
Drift
Task
Force
(
SDTF).
The
main
differences
between
versions
1.2
and
2.0
include:
(
a)
an
entirely
new
binding
curve
to
represent
dissolved
Page
36
of
72
concentration
as
a
function
of
Kd;
(
b)
the
use
of
the
binding
parameter,
Kd
in
preference
to
Koc
to
represent
pesticide
attachment
to
soil,
to
organic
matter
or
to
water
body
bottom
sediments;
(
c)
changes
in
the
recommendation
for
depth
of
incorporation;
(
d)
a
change
in
the
timing
of
the
single
event
rainstorm
for
chemicals
which
receive
multiple
applications;
(
e)
addition
of
a
subroutine
from
the
SDTF
to
estimate
spray
drift;
and
(
f)
a
change
in
the
time
durations
of
the
output
values
to
better
match
the
durations
of
relevant
toxicity
tests.
For
additional
details
see,
"
Development
and
Use
of
GENEEC
Version
2.0
for
Pesticide
Aquatic
Ecological
Exposure
Assessment".
EFED
uses
a
tiered
system
of
pesticide
exposure
modeling
to
assess
risk
of
a
pesticidal
product
to
the
environment.
This
tiered
system
is
designed
to
minimize
the
amount
of
analysis
which
is
required
to
register
any
given
chemical.
Each
of
the
tiers
is
designed
to
screen
out
pesticides
by
requiring
higher,
more
complex
levels
of
investigation
only
for
those
that
have
not
passed
the
next
lower
tier.
Each
tier
screens
out
a
percentage
of
pesticides
from
having
to
undergo
a
more
rigorous
review
prior
to
registration
or
reregistration.
The
GENEEC
(
GENeric
Estimated
Environmental
Concentration)
model,
the
tier
one
computer
program,
uses
a
the
soil/
water
partition
coefficient
and
degradation
kinetic
data
to
estimate
runoff
from
a
ten
hectare
field
into
a
one
hectare
by
two
meter
deep
"
standard"
pond.
This
first
tier
is
designed
as
a
coarse
screen
and
estimates
conservative
pesticide
concentrations
in
surface
water
from
a
few
basic
chemical
parameters
and
pesticide
label
use
and
application
information.
Tier
1
is
used
to
screen
chemicals
to
determine
which
ones
potentially
pose
sufficient
risk
to
warrant
higher
level
modeling.
Chemicals
failing
to
pass
this
program,
move
on
to
the
tier
two
modeling.
As
a
matter
of
policy,
OPP
does
not
take
significant
adverse
regulatory
action
based
upon
the
results
of
Tier
1
screening
models.
GENEEC
is
a
program
to
calculate
acute
and
long
term
estimated
environmental
concentration
(
EEC)
values.
It
considers
reduction
in
dissolved
pesticide
concentration
due
to
adsorption
of
pesticide
to
soil
or
sediment,
incorporation,
degradation
in
soil
before
run
off
to
a
water
body,
direct
deposition
of
spray
drift
into
the
water
body,
and
degradation
of
the
pesticide
within
the
water
body.
It
is
designed
to
mimic
a
PRZM
EXAMS
simulation
GENEEC
2.0
Runs
for
Diuron
on
various
crops
RUN
No.
1
FOR
diuron
ON
grape
*
INPUT
VALUES
*
RATE
(#/
AC)
No.
APPS
&
SOIL
SOLUBIL
APPL
TYPE
NO
SPRAY
INCORP
ONE(
MULT)
INTERVAL
Koc
(
PPM
)
(%
DRIFT)
(
FT)
(
IN)
9.600(
9.600)
1
1
468.0
42.0
GRHIFI(
6.6)
.0
.0
FIELD
AND
STANDARD
POND
HALF
LIFE
VALUES
(
DAYS)
METABOLIC
DAYS
UNTIL
HYDROLYSIS
PHOTOLYSIS
METABOLIC
COMBINED
(
FIELD)
RAIN/
RUNOFF
(
POND)
(
POND
EFF)
(
POND)
(
POND)
1116.00
2
N/
A
43.00
5332.00
33.00
32.80
Page
37
of
72
GENERIC
EECs
(
IN
MICROGRAMS/
LITER
(
PPB))
Version
2.0
12/
1/
2000
PEAK
MAX
4
DAY
MAX
21
DAY
MAX
60
DAY
MAX
90
DAY
GEEC
AVG
GEEC
AVG
GEEC
AVG
GEEC
AVG
GEEC
329.85
316.29
266.38
186.93
147.53
RUN
No.
2
FOR
diuron
ON
citrus
*
INPUT
VALUES
*
RATE
(#/
AC)
No.
APPS
&
SOIL
SOLUBIL
APPL
TYPE
NO
SPRAY
INCORP
ONE(
MULT)
INTERVAL
Koc
(
PPM
)
(%
DRIFT)
(
FT)
(
IN)
6.400(
6.400)
1
1
468.0
42.0
GRHIFI(
6.6)
.0
.0
FIELD
AND
STANDARD
POND
HALF
LIFE
VALUES
(
DAYS)
METABOLIC
DAYS
UNTIL
HYDROLYSIS
PHOTOLYSIS
METABOLIC
COMBINED
(
FIELD)
RAIN/
RUNOFF
(
POND)
(
POND
EFF)
(
POND)
(
POND)
1116.00
2
N/
A
43.00
5332.00
33.00
32.80
GENERIC
EECs
(
IN
MICROGRAMS/
LITER
(
PPB))
Version
2.0
12/
1/
2000
PEAK
MAX
4
DAY
MAX
21
DAY
MAX
60
DAY
MAX
90
DAY
GEEC
AVG
GEEC
AVG
GEEC
AVG
GEEC
AVG
GEEC
219.90
210.86
177.58
124.62
98.35
RUN
No.
3
FOR
diuron
ON
alfalfa
*
INPUT
VALUES
*
RATE
(#/
AC)
No.
APPS
&
SOIL
SOLUBIL
APPL
TYPE
NO
SPRAY
INCORP
ONE(
MULT)
INTERVAL
Koc
(
PPM
)
(%
DRIFT)
(
FT)
(
IN)
3.200(
3.200)
1
1
468.0
42.0
AERL_
B(
13.0)
.0
.0
FIELD
AND
STANDARD
POND
HALF
LIFE
VALUES
(
DAYS)
METABOLIC
DAYS
UNTIL
HYDROLYSIS
PHOTOLYSIS
METABOLIC
COMBINED
(
FIELD)
RAIN/
RUNOFF
(
POND)
(
POND
EFF)
(
POND)
(
POND)
1116.00
2
N/
A
43.00
5332.00
33.00
32.80
GENERIC
EECs
(
IN
MICROGRAMS/
LITER
(
PPB))
Version
2.0
12/
1/
2000
PEAK
MAX
4
DAY
MAX
21
DAY
MAX
60
DAY
MAX
90
DAY
GEEC
AVG
GEEC
AVG
GEEC
AVG
GEEC
AVG
GEEC
Page
38
of
72
116.40
111.62
94.00
65.97
52.06
RUN
No.
4
FOR
diuron
ON
peaches
*
INPUT
VALUES
*
RATE
(#/
AC)
No.
APPS
&
SOIL
SOLUBIL
APPL
TYPE
NO
SPRAY
INCORP
ONE(
MULT)
INTERVAL
Koc
(
PPM
)
(%
DRIFT)
(
FT)
(
IN)
4.000(
4.000)
1
1
468.0
42.0
GRHIFI(
6.6)
.0
.0
FIELD
AND
STANDARD
POND
HALF
LIFE
VALUES
(
DAYS)
METABOLIC
DAYS
UNTIL
HYDROLYSIS
PHOTOLYSIS
METABOLIC
COMBINED
(
FIELD)
RAIN/
RUNOFF
(
POND)
(
POND
EFF)
(
POND)
(
POND)
1116.00
2
N/
A
43.00
5332.00
33.00
32.80
GENERIC
EECs
(
IN
MICROGRAMS/
LITER
(
PPB))
Version
2.0
12/
1/
2000
PEAK
MAX
4
DAY
MAX
21
DAY
MAX
60
DAY
MAX
90
DAY
GEEC
AVG
GEEC
AVG
GEEC
AVG
GEEC
AVG
GEEC
137.44
131.79
110.99
77.89
61.47
RUN
No.
5
FOR
diuron
ON
sugarcane
*
INPUT
VALUES
*
RATE
(#/
AC)
No.
APPS
&
SOIL
SOLUBIL
APPL
TYPE
NO
SPRAY
INCORP
ONE(
MULT)
INTERVAL
Koc
(
PPM
)
(%
DRIFT)
(
FT)
(
IN)
3.200(
3.200)
1
1
468.0
42.0
AERL_
B(
13.0)
.0
.0
FIELD
AND
STANDARD
POND
HALF
LIFE
VALUES
(
DAYS)
METABOLIC
DAYS
UNTIL
HYDROLYSIS
PHOTOLYSIS
METABOLIC
COMBINED
(
FIELD)
RAIN/
RUNOFF
(
POND)
(
POND
EFF)
(
POND)
(
POND)
1116.00
2
N/
A
43.00
5332.00
33.00
32.80
GENERIC
EECs
(
IN
MICROGRAMS/
LITER
(
PPB))
Version
2.0
12/
1/
2000
PEAK
MAX
4
DAY
MAX
21
DAY
MAX
60
DAY
MAX
90
DAY
GEEC
AVG
GEEC
AVG
GEEC
AVG
GEEC
AVG
GEEC
116.40
111.62
94.00
65.97
52.06
RUN
No.
6
FOR
diuron
ON
cotton
*
INPUT
VALUES
*
RATE
(#/
AC)
No.
APPS
&
SOIL
SOLUBIL
APPL
TYPE
NO
SPRAY
INCORP
ONE(
MULT)
INTERVAL
Koc
(
PPM
)
(%
DRIFT)
(
FT)
(
IN)
Page
39
of
72
1.600(
1.600)
1
1
468.0
42.0
AERL_
B(
13.0)
.0
.0
FIELD
AND
STANDARD
POND
HALF
LIFE
VALUES
(
DAYS)
METABOLIC
DAYS
UNTIL
HYDROLYSIS
PHOTOLYSIS
METABOLIC
COMBINED
(
FIELD)
RAIN/
RUNOFF
(
POND)
(
POND
EFF)
(
POND)
(
POND)
1116.00
2
N/
A
43.00
5332.00
33.00
32.80
GENERIC
EECs
(
IN
MICROGRAMS/
LITER
(
PPB))
Version
2.0
12/
1/
2000
PEAK
MAX
4
DAY
MAX
21
DAY
MAX
60
DAY
MAX
90
DAY
GEEC
AVG
GEEC
AVG
GEEC
AVG
GEEC
AVG
GEEC
58.20
55.81
47.00
32.98
26.03
RUN
No.
7
FOR
diuron
ON
railroads
*
INPUT
VALUES
*
RATE
(#/
AC)
No.
APPS
&
SOIL
SOLUBIL
APPL
TYPE
NO
SPRAY
INCORP
ONE(
MULT)
INTERVAL
Koc
(
PPM
)
(%
DRIFT)
(
FT)
(
IN)
12.000(
12.000)
1
1
468.0
42.0
AERL_
B(
13.0)
.0
.0
FIELD
AND
STANDARD
POND
HALF
LIFE
VALUES
(
DAYS)
METABOLIC
DAYS
UNTIL
HYDROLYSIS
PHOTOLYSIS
METABOLIC
COMBINED
(
FIELD)
RAIN/
RUNOFF
(
POND)
(
POND
EFF)
(
POND)
(
POND)
1116.00
2
N/
A
43.00
5332.00
33.00
32.80
GENERIC
EECs
(
IN
MICROGRAMS/
LITER
(
PPB))
Version
2.0
12/
1/
2000
PEAK
MAX
4
DAY
MAX
21
DAY
MAX
60
DAY
MAX
90
DAY
GEEC
AVG
GEEC
AVG
GEEC
AVG
GEEC
AVG
GEEC
436.51
418.57
352.52
247.38
195.24
RUN
No.
8
FOR
diuron
ON
roadsides
*
INPUT
VALUES
*
RATE
(#/
AC)
No.
APPS
&
SOIL
SOLUBIL
APPL
TYPE
NO
SPRAY
INCORP
ONE(
MULT)
INTERVAL
Koc
(
PPM
)
(%
DRIFT)
(
FT)
(
IN)
12.000(
12.000)
1
1
468.0
42.0
GRHIFI(
6.6)
.0
.0
FIELD
AND
STANDARD
POND
HALF
LIFE
VALUES
(
DAYS)
METABOLIC
DAYS
UNTIL
HYDROLYSIS
PHOTOLYSIS
METABOLIC
COMBINED
(
FIELD)
RAIN/
RUNOFF
(
POND)
(
POND
EFF)
(
POND)
(
POND)
Page
40
of
72
1116.00
2
N/
A
43.00
5332.00
33.00
32.80
GENERIC
EECs
(
IN
MICROGRAMS/
LITER
(
PPB))
Version
2.0
12/
1/
2000
PEAK
MAX
4
DAY
MAX
21
DAY
MAX
60
DAY
MAX
90
DAY
GEEC
AVG
GEEC
AVG
GEEC
AVG
GEEC
AVG
GEEC
412.31
395.36
332.97
233.66
184.41
Background
Information
on
PRZM
EXAMS
There
are
several
factors
which
may
limit
the
accuracy
and
precision
of
the
PRZM
EXAMS
modeling.
These
include
the
selection
of
the
typical
exposure
scenarios,
the
quality
of
the
input
data,
the
ability
of
the
models
to
represent
the
real
world
and
the
number
of
years
that
were
modeled.
The
scenarios
that
are
selected
for
use
in
Tier
II
EEC
calculations
are
the
ones
that
are
likely
to
produce
large
concentrations
in
the
aquatic
environment.
Each
scenario
should
represent
a
real
site
to
which
the
pesticide
of
concern
is
likely
to
be
applied.
The
EEC's
in
this
analysis
are
accurate
only
to
the
extent
that
the
site
represents
the
hypothetical
high
exposure
site.
The
most
limiting
part
of
the
site
selection
is
the
use
of
the
standard
pond
with
no
outlet.
A
standard
pond
is
used
because
it
provides
a
basis
for
comparing
pesticides
in
different
regions
of
the
country
on
equal
terms.
The
models
also
have
limitations
in
their
ability
to
represent
some
processes.
The
greatest
limitation
is
the
handling
of
spray
drift.
A
second
major
limitation
is
the
lack
of
validation
at
the
field
level
for
pesticide
runoff.
Page
41
of
72
PRZM/
EXAMS
RUN
INPUT
AND
OUTPUT
IR
PCA
RUN
FOR
DIURON
ON
CITRUS
INPUT
FILE
PRZM3
Input
File,
flcit.
inp
(
Jan
28
2000)
Location:
Osceola
County,
FL.;
Crop:
citrus;
MLRA
156A
0.77
0.15
0
25.00
1
1
4
0.10
0.13
1.00
172.8
4
1.00
600.0
1
1
0.10
100.00
80.00
3
94
84
89
0.00
100.00
1
3
0101
21
9
2209
0.10
0.10
0.10
.023
.023
.023
36
020148
030148
311248
1
020149
030149
311249
1
020150
030150
311250
1
020151
030151
311251
1
020152
030152
311252
1
020153
030153
311253
1
020154
030154
311254
1
020155
030155
311255
1
020156
030156
311256
1
020157
030157
311257
1
020158
030158
311258
1
020159
030159
311259
1
020160
030160
311260
1
020161
030161
311261
1
020162
030162
311262
1
020163
030163
311263
1
020164
030164
311264
1
020165
030165
311265
1
020166
030166
311266
1
020167
030167
311267
1
020168
030168
311268
1
020169
030169
311269
1
020170
030170
311270
1
020171
030171
311271
1
020172
030172
311272
1
020173
030173
311273
1
020174
030174
311274
1
020175
030175
311275
1
020176
030176
311276
1
020177
030177
311277
1
020178
030178
311278
1
Page
42
of
72
020179
030179
311279
1
020180
030180
311280
1
020181
030181
311281
1
020182
030182
311282
1
020183
030183
311283
1
Application:
Diuron:
One
ground
appl.@
9.6
lb
a.
i./
ac
(
10.7
Kg/
h)
@
99%
eff,
w/
64%
drift
36
1
0
0
Diruon
010748
0
2
0.00
10.7
0.99
0.064
010749
0
2
0.00
10.7
0.99
0.063
010750
0
2
0.00
10.7
0.99
0.064
010751
0
2
0.00
10.7
0.99
0.064
010752
0
2
0.00
10.7
0.99
0.064
010753
0
2
0.00
10.7
0.99
0.064
010754
0
2
0.00
10.7
0.99
0.064
010755
0
2
0.00
10.7
0.99
0.064
010756
0
2
0.00
10.7
0.99
0.064
010757
0
2
0.00
10.7
0.99
0.064
010758
0
2
0.00
10.7
0.99
0.064
010759
0
2
0.00
10.7
0.99
0.064
010760
0
2
0.00
10.7
0.99
0.064
010761
0
2
0.00
10.7
0.99
0.064
010762
0
2
0.00
10.7
0.99
0.064
010763
0
2
0.00
10.7
0.99
0.064
010764
0
2
0.00
10.7
0.99
0.064
010765
0
2
0.00
10.7
0.99
0.064
010766
0
2
0.00
10.7
0.99
0.064
010767
0
2
0.00
10.7
0.99
0.064
010768
0
2
0.00
10.7
0.99
0.064
010769
0
2
0.00
10.7
0.99
0.064
010770
0
2
0.00
10.7
0.99
0.064
010771
0
2
0.00
10.7
0.99
0.064
010772
0
2
0.00
10.7
0.99
0.064
010773
0
2
0.00
10.7
0.99
0.064
010774
0
2
0.00
10.7
0.99
0.064
010775
0
2
0.00
10.7
0.99
0.064
010776
0
2
0.00
10.7
0.99
0.064
010777
0
2
0.00
10.7
0.99
0.064
010778
0
2
0.00
10.7
0.99
0.064
010779
0
2
0.00
10.7
0.99
0.064
010780
0
2
0.00
10.7
0.99
0.064
010781
0
2
0.00
10.7
0.99
0.064
010782
0
2
0.00
10.7
0.99
0.064
010783
0
2
0.00
10.7
0.99
0.064
0.00
1
0.00
0.00
0.000
0.50
Soil
Series:
Adamsville
sand;
Hydrogic
Group
C
100.00
0
0
0
0
0
0
0
0
0
0.0
0.00
00.00
3
Page
43
of
72
1
10.000
1.440
0.086
0.000
0.000
0.000
.0009
.0009
0.000
0.100
0.086
0.036
0.580
14.00
2
10.000
1.440
0.086
0.000
0.000
0.000
.0009
.0009
0.000
1.000
0.086
0.036
0.580
14.00
3
80.000
1.580
0.030
0.000
0.000
0.000
.0009
.0009
0.000
5.000
0.030
0.023
0.116
14.00
0
WATR
YEAR
10
PEST
YEAR
10
CONC
YEAR
10
1
6
11
1
DAY
RUNF
TSER
0
0
1.
E0
IR
PCA
RUN
FOR
DIURON
ON
CITRUS
OUTPUT
FILE
WATER
COLUMN
DISSOLVED
CONCENTRATION
(
PPB)
YEAR
PEAK
96
HOUR
21
DAY
60
DAY
90
DAY
YEARLY
1948
158.000
153.000
140.000
130.000
125.000
52.920
1949
101.000
97.610
86.240
82.120
74.800
31.870
1950
143.000
138.000
127.000
119.000
109.000
46.430
1951
304.000
295.000
262.000
207.000
175.000
66.420
1952
474.000
459.000
402.000
315.000
269.000
106.000
1953
203.000
196.000
175.000
159.000
148.000
64.180
1954
254.000
246.000
232.000
184.000
167.000
65.390
1955
140.000
136.000
120.000
102.000
92.510
42.070
1956
172.000
167.000
153.000
127.000
109.000
42.610
1957
396.000
385.000
338.000
304.000
274.000
102.000
1958
133.000
131.000
120.000
102.000
96.790
42.640
1959
181.000
175.000
158.000
149.000
142.000
56.390
1960
295.000
285.000
267.000
218.000
184.000
70.800
1961
96.630
93.500
82.100
73.890
66.550
34.640
1962
154.000
149.000
138.000
116.000
101.000
43.860
1963
205.000
198.000
180.000
144.000
120.000
45.910
1964
344.000
332.000
291.000
236.000
208.000
78.740
1965
170.000
164.000
147.000
126.000
116.000
57.240
1966
122.000
118.000
105.000
89.450
78.750
36.310
1967
226.000
221.000
196.000
175.000
159.000
64.070
1968
163.000
158.000
146.000
118.000
107.000
46.730
1969
210.000
203.000
188.000
158.000
145.000
56.510
1970
126.000
122.000
108.000
83.850
70.660
31.660
1971
117.000
115.000
104.000
88.730
82.850
38.460
1972
208.000
203.000
186.000
166.000
150.000
55.690
Page
44
of
72
1973
137.000
133.000
122.000
103.000
92.350
41.870
1974
148.000
143.000
129.000
104.000
90.740
36.060
1975
124.000
120.000
104.000
93.360
84.230
36.300
1976
192.000
187.000
166.000
134.000
115.000
49.610
1977
121.000
117.000
103.000
96.110
91.580
40.360
1978
36.240
35.350
32.140
27.760
26.250
16.470
1979
172.000
166.000
145.000
128.000
119.000
48.840
1980
194.000
189.000
172.000
165.000
147.000
58.120
1981
328.000
317.000
285.000
246.000
210.000
76.380
1982
65.870
63.990
59.360
48.360
45.370
28.480
1983
283.000
277.000
248.000
195.000
165.000
58.770
SORTED
FOR
PLOTTING
PROB
PEAK
96
HOUR
21
DAY
60
DAY
90
DAY
YEARLY
.027
474.000
459.000
402.000
315.000
274.000
106.000
.054
396.000
385.000
338.000
304.000
269.000
102.000
.081
344.000
332.000
291.000
246.000
210.000
78.740
.108
328.000
317.000
285.000
236.000
208.000
76.380
.135
304.000
295.000
267.000
218.000
184.000
70.800
.162
295.000
285.000
262.000
207.000
175.000
66.420
.189
283.000
277.000
248.000
195.000
167.000
65.390
.216
254.000
246.000
232.000
184.000
165.000
64.180
.243
226.000
221.000
196.000
175.000
159.000
64.070
.270
210.000
203.000
188.000
166.000
150.000
58.770
.297
208.000
203.000
186.000
165.000
148.000
58.120
.324
205.000
198.000
180.000
159.000
147.000
57.240
.351
203.000
196.000
175.000
158.000
145.000
56.510
.378
194.000
189.000
172.000
149.000
142.000
56.390
.405
192.000
187.000
166.000
144.000
125.000
55.690
.432
181.000
175.000
158.000
134.000
120.000
52.920
.459
172.000
167.000
153.000
130.000
119.000
49.610
.486
172.000
166.000
147.000
128.000
116.000
48.840
.514
170.000
164.000
146.000
127.000
115.000
46.730
.541
163.000
158.000
145.000
126.000
109.000
46.430
.568
158.000
153.000
140.000
119.000
109.000
45.910
.595
154.000
149.000
138.000
118.000
107.000
43.860
.622
148.000
143.000
129.000
116.000
101.000
42.640
.649
143.000
138.000
127.000
104.000
96.790
42.610
.676
140.000
136.000
122.000
103.000
92.510
42.070
.703
137.000
133.000
120.000
102.000
92.350
41.870
.730
133.000
131.000
120.000
102.000
91.580
40.360
.757
126.000
122.000
108.000
96.110
90.740
38.460
.784
124.000
120.000
105.000
93.360
84.230
36.310
.811
122.000
118.000
104.000
89.450
82.850
36.300
.838
121.000
117.000
104.000
88.730
78.750
36.060
.865
117.000
115.000
103.000
83.850
74.800
34.640
Page
45
of
72
.892
101.000
97.610
86.240
82.120
70.660
31.870
.919
96.630
93.500
82.100
73.890
66.550
31.660
.946
65.870
63.990
59.360
48.360
45.370
28.480
.973
36.240
35.350
32.140
27.760
26.250
16.470
1/
10
332.800
321.500
286.800
239.000
208.600
77.088
MEAN
OF
ANNUAL
VALUES
=
51.967
STANDARD
DEVIATION
OF
ANNUAL
VALUES
=
18.884
UPPER
90%
CONFIDENCE
LIMIT
ON
MEAN
=
56.627
PRZM/
EXAMS
INPUT
FILE
FOR
DIURON
ON
CA
GRAPES
***
PRZM
3.1
Input
Data
File
converted
from
PRZM
2.3***
***
CaGrape.
INP,
created
22
March
1999;
Stanislaus
county,
CA.***
***
Soil
Hanford,
Hydrologic
Group
B
***
***
Assume
poor
grass
coverage
under
vines
and
overland
flow***
***
Pesticide
is
ground
spray
applied***
***
This
is
intended
to
use
a
modified
metfile,
incorporating
irrigation
***
***
cropping
curve
number
reduced
from
78
to
fit
the
15%
of
flood
irrigation
***
***
water
which
runs
off.
The
15%
number
comes
from
Terry
Pritchard,
***
***
San
Joachin
county
cooperative
extension,
(
209)
468
2085
***
Diuron
Hanford
fine
sandyloam;
MLRA
L
17,
Stanislaus
County,
CA,
Grapes
0.852
0.450
0
15.00
1
3
4
0.34
0.15
1.00
10
5.80
1
0.500
354
1
1
0.25
90.00
100.00
3
86
59
82
0.00
150.0
1
3
0101
0110
0111
0.05
0.05
0.05
.023
.023
.023
36
070448
300648
311048
1
070449
300649
311049
1
070450
300650
311050
1
070451
300651
311051
1
070452
300652
311052
1
070453
300653
311053
1
070454
300654
311054
1
070455
300655
311055
1
070456
300656
311056
1
070457
300657
311057
1
Page
46
of
72
070458
300658
311058
1
070459
300659
311059
1
070460
300660
311060
1
070461
300661
311061
1
070462
300662
311062
1
070463
300663
311063
1
070464
300664
311064
1
070465
300665
311065
1
070466
300666
311066
1
070467
300667
311067
1
070468
300668
311068
1
070469
300669
311069
1
070470
300670
311070
1
070471
300671
311071
1
070472
300672
311072
1
070473
300673
311073
1
070474
300674
311074
1
070475
300675
311075
1
070476
300676
311076
1
070477
300677
311077
1
070478
300678
311078
1
070479
300679
311079
1
070480
300680
311080
1
070481
300681
311081
1
070482
300682
311082
1
070483
300683
311083
1
Application
Schedule:
1
ground
spray
app,
9.6
lb
a.
i./
acre,
99%
effic.
w/
1%
drift
36
1
0
0
Diuron
Kd:
14
(
SANDY
LOAM);
ASM:
T1/
2
=
372
days
050148
0
2
0.0
10.80
0.99
0.01
050149
0
2
0.0
10.80
0.99
0.01
050150
0
2
0.0
10.80
0.99
0.01
050151
0
2
0.0
10.80
0.99
0.01
050152
0
2
0.0
10.80
0.99
0.01
050153
0
2
0.0
10.80
0.99
0.01
050154
0
2
0.0
10.80
0.99
0.01
050155
0
2
0.0
10.80
0.99
0.01
050156
0
2
0.0
10.80
0.99
0.01
050157
0
2
0.0
10.80
0.99
0.01
050158
0
2
0.0
10.80
0.99
0.01
050159
0
2
0.0
10.80
0.99
0.01
050160
0
2
0.0
10.80
0.99
0.01
050161
0
2
0.0
10.80
0.99
0.01
050162
0
2
0.0
10.80
0.99
0.01
050163
0
2
0.0
10.80
0.99
0.01
050164
0
2
0.0
10.80
0.99
0.01
050165
0
2
0.0
10.80
0.99
0.01
050166
0
2
0.0
10.80
0.99
0.01
050167
0
2
0.0
10.80
0.99
0.01
050168
0
2
0.0
10.80
0.99
0.01
Page
47
of
72
050169
0
2
0.0
10.80
0.99
0.01
050170
0
2
0.0
10.80
0.99
0.01
050171
0
2
0.0
10.80
0.99
0.01
050172
0
2
0.0
10.80
0.99
0.01
050173
0
2
0.0
10.80
0.99
0.01
050174
0
2
0.0
10.80
0.99
0.01
050175
0
2
0.0
10.80
0.99
0.01
050176
0
2
0.0
10.80
0.99
0.01
050177
0
2
0.0
10.80
0.99
0.01
050178
0
2
0.0
10.80
0.99
0.01
050179
0
2
0.0
10.80
0.99
0.01
050180
0
2
0.0
10.80
0.99
0.01
050181
0
2
0.0
10.80
0.99
0.01
050182
0
2
0.0
10.80
0.99
0.01
050183
0
2
0.0
10.80
0.99
0.01
0.0
3
0.0
0.0
Hanford
fine
sandy
Loam;
Hydrologic
Group
B;
150.00
0
0
0
0
0
0
0
0
0
0.0
0.0
0.5
3
1
30.00
1.500
0.222
0.000
0.000
0.00
0.002
0.002
0.000
0.1
0.125
0.050
0.750
14.0
2
60.00
1.500
0.210
0.000
0.000
0.00
0.002
0.002
0.000
1.0
0.120
0.050
0.200
14.0
3
60.00
1.500
0.200
0.000
0.000
0.00
0.002
0.002
0.000
5.0
0.100
0.050
0.125
14.0
0
YEAR
10
YEAR
10
YEAR
10
1
1
1
7
YEAR
PRCP
TCUM
0
0
RUNF
TCUM
0
0
INFL
TCUM
1
1
ESLS
TCUM
0
0
1.0E3
RFLX
TCUM
0
0
1.0E5
EFLX
TCUM
0
0
1.0E5
RZFX
TCUM
0
0
1.0E5
PRZM/
EXAMS
OUTPUT
FILE
FOR
DIURON
ON
CA
GRAPES
WATER
COLUMN
DISSOLVED
CONCENTRATION
(
PPB)
Page
48
of
72
YEAR
PEAK
96
HOUR
21
DAY
60
DAY
90
DAY
YEARLY
1948
5.398
5.320
5.032
4.560
4.310
3.192
1949
7.804
7.724
7.425
6.923
6.647
5.193
1950
9.402
9.320
9.013
8.493
8.200
6.521
1951
10.460
10.380
10.070
9.534
9.230
7.402
1952
12.190
12.110
11.800
11.300
11.030
9.070
1953
13.180
13.090
12.750
12.160
11.810
9.581
1954
19.280
19.110
18.490
17.420
16.810
13.410
1955
17.680
17.570
17.170
16.710
16.390
13.550
1956
16.060
15.970
15.630
15.030
14.670
12.050
1957
14.870
14.790
14.450
13.870
13.520
11.080
1958
15.970
15.880
15.540
14.970
14.560
12.580
1959
15.700
15.610
15.270
14.680
14.320
11.750
1960
19.070
18.910
18.320
16.960
14.350
12.320
1961
21.430
21.300
20.800
19.930
19.410
15.900
1962
39.790
39.430
38.050
35.680
34.510
26.600
1963
35.440
35.230
34.440
33.080
32.240
26.750
1964
26.950
26.850
26.460
25.730
25.250
21.100
1965
22.090
21.990
21.630
20.960
20.660
17.740
1966
23.070
22.940
22.460
21.580
21.020
17.680
1967
20.480
20.370
20.080
19.620
19.210
15.900
1968
18.070
17.980
17.620
16.990
16.610
13.700
1969
17.580
17.520
17.180
16.540
16.110
13.790
1970
18.860
18.760
18.350
17.590
17.120
14.400
1971
17.440
17.340
16.980
16.340
15.950
13.120
1972
15.720
15.630
15.300
14.700
14.340
11.810
1973
22.440
22.250
21.550
20.340
19.800
15.960
1974
22.700
22.550
22.010
21.000
20.360
17.090
1975
21.500
21.400
21.020
20.520
20.270
16.910
1976
18.740
18.650
18.300
18.060
17.780
14.800
1977
17.950
17.860
17.520
16.860
16.400
14.400
1978
94.320
93.150
88.790
81.590
77.600
55.850
1979
51.980
51.860
51.590
50.720
49.980
42.290
1980
39.770
39.650
39.210
38.500
38.080
32.230
1981
31.530
31.430
31.010
30.560
30.160
25.390
1982
25.530
25.430
25.050
24.330
24.030
20.580
1983
28.440
28.270
27.600
26.660
26.070
21.590
SORTED
FOR
PLOTTING
PROB
PEAK
96
HOUR
21
DAY
60
DAY
90
DAY
YEARLY
0.027
94.320
93.150
88.790
81.590
77.600
55.850
0.054
51.980
51.860
51.590
50.720
49.980
42.290
0.081
39.790
39.650
39.210
38.500
38.080
32.230
0.108
39.770
39.430
38.050
35.680
34.510
26.750
0.135
35.440
35.230
34.440
33.080
32.240
26.600
Page
49
of
72
0.162
31.530
31.430
31.010
30.560
30.160
25.390
0.189
28.440
28.270
27.600
26.660
26.070
21.590
0.216
26.950
26.850
26.460
25.730
25.250
21.100
0.243
25.530
25.430
25.050
24.330
24.030
20.580
0.270
23.070
22.940
22.460
21.580
21.020
17.740
0.297
22.700
22.550
22.010
21.000
20.660
17.680
0.324
22.440
22.250
21.630
20.960
20.360
17.090
0.351
22.090
21.990
21.550
20.520
20.270
16.910
0.378
21.500
21.400
21.020
20.340
19.800
15.960
0.405
21.430
21.300
20.800
19.930
19.410
15.900
0.432
20.480
20.370
20.080
19.620
19.210
15.900
0.459
19.280
19.110
18.490
18.060
17.780
14.800
0.486
19.070
18.910
18.350
17.590
17.120
14.400
0.514
18.860
18.760
18.320
17.420
16.810
14.400
0.541
18.740
18.650
18.300
16.990
16.610
13.790
0.568
18.070
17.980
17.620
16.960
16.400
13.700
0.595
17.950
17.860
17.520
16.860
16.390
13.550
0.622
17.680
17.570
17.180
16.710
16.110
13.410
0.649
17.580
17.520
17.170
16.540
15.950
13.120
0.676
17.440
17.340
16.980
16.340
14.670
12.580
0.703
16.060
15.970
15.630
15.030
14.560
12.320
0.730
15.970
15.880
15.540
14.970
14.350
12.050
0.757
15.720
15.630
15.300
14.700
14.340
11.810
0.784
15.700
15.610
15.270
14.680
14.320
11.750
0.811
14.870
14.790
14.450
13.870
13.520
11.080
0.838
13.180
13.090
12.750
12.160
11.810
9.581
0.865
12.190
12.110
11.800
11.300
11.030
9.070
0.892
10.460
10.380
10.070
9.534
9.230
7.402
0.919
9.402
9.320
9.013
8.493
8.200
6.521
0.946
7.804
7.724
7.425
6.923
6.647
5.193
0.973
5.398
5.320
5.032
4.560
4.310
3.192
1/
10
39.776
39.496
38.398
36.526
35.581
28.394
MEAN
OF
ANNUAL
VALUES
=
17.036
STANDARD
DEVIATION
OF
ANNUAL
VALUES
=
10.111
UPPER
90%
CONFIDENCE
LIMIT
ON
MEAN
=
19.531
PRZM/
EXAMS
INPUT
FILE
FOR
DIURON
ON
FL
CITRUS
***
PRZM
3.12
Input
Data
File
***
***
Modeler:
I.
Abdel
Saheb
***
***
Assume
bare
soil
underneath
the
trees
for
heating
***
***
MET156A.
MET
***
***
2
air
blast
apps
@
0.99
lb
a.
i/
a,
95%
appl
eff,
0.05%
spray
drift
***
Page
50
of
72
MBC
from
benomyl
Adamsville
Sand;
MLRA
U
156A,
Osceola
County,
FL
0.770
0.150
0
25.00
1
1
4
0.10
0.13
1.00
10.00
3
1.00
345.0
1
1
0.10
100.00
80.00
3
91
74
83
0.0
600
0.00
1
3
0101
21
9
2209
0.10
0.10
0.10
.023
.023
.023
36
020148
030148
310148
1
020149
030149
310149
1
020150
030150
310150
1
020151
030151
310151
1
020152
030152
310152
1
020153
030153
310153
1
020154
030154
310154
1
020155
030155
310155
1
020156
030156
310156
1
020157
030157
310157
1
020158
030158
310158
1
020159
030159
310159
1
020160
030160
310160
1
020161
030161
310161
1
020162
030162
310162
1
020163
030163
310163
1
020164
030164
310164
1
020165
030165
310165
1
020166
030166
310166
1
020167
030167
310167
1
020168
030168
310168
1
020169
030169
310169
1
020170
030170
310170
1
020171
030171
310171
1
020172
030172
310172
1
020173
030173
310173
1
020174
030174
310174
1
020175
030175
310175
1
020176
030176
310176
1
020177
030177
310177
1
020178
030178
310178
1
020179
030179
310179
1
020180
030180
310180
1
020181
030181
310181
1
020182
030182
310182
1
020183
030183
310183
1
Application
schedule:
One
ground
appl.
@
6.4
lb
a.
i/
a,
99%
appl
eff,
0.01
%
spray
drift
36
1
0
Page
51
of
72
Diuron
010748
0
2
0.00
7.20
0.99
0.010
010749
0
2
0.00
7.20
0.99
0.010
010750
0
2
0.00
7.20
0.99
0.010
010751
0
2
0.00
7.20
0.99
0.010
010752
0
2
0.00
7.20
0.99
0.010
010753
0
2
0.00
7.20
0.99
0.010
010754
0
2
0.00
7.20
0.99
0.010
010755
0
2
0.00
7.20
0.99
0.010
010756
0
2
0.00
7.20
0.99
0.010
010757
0
2
0.00
7.20
0.99
0.010
010758
0
2
0.00
7.20
0.99
0.010
010759
0
2
0.00
7.20
0.99
0.010
010760
0
2
0.00
7.20
0.99
0.010
010761
0
2
0.00
7.20
0.99
0.010
010762
0
2
0.00
7.20
0.99
0.010
010763
0
2
0.00
7.20
0.99
0.010
010764
0
2
0.00
7.20
0.99
0.010
010765
0
2
0.00
7.20
0.99
0.010
010766
0
2
0.00
7.20
0.99
0.010
010767
0
2
0.00
7.20
0.99
0.010
010768
0
2
0.00
7.20
0.99
0.010
010769
0
2
0.00
7.20
0.99
0.010
010770
0
2
0.00
7.20
0.99
0.010
010771
0
2
0.00
7.20
0.99
0.010
010772
0
2
0.00
7.20
0.99
0.010
010773
0
2
0.00
7.20
0.99
0.010
010774
0
2
0.00
7.20
0.99
0.010
010775
0
2
0.00
7.20
0.99
0.010
010776
0
2
0.00
7.20
0.99
0.010
010777
0
2
0.00
7.20
0.99
0.010
010778
0
2
0.00
7.20
0.99
0.010
010779
0
2
0.00
7.20
0.99
0.010
010780
0
2
0.00
7.20
0.99
0.010
010781
0
2
0.00
7.20
0.99
0.010
010782
0
2
0.00
7.20
0.99
0.010
010783
0
2
0.00
7.20
0.99
0.010
0.
1
0.0
0.072
0.5
Adamsville
Sand;
Hydrologic
Group
C
100.00
0
0
0
0
0
0
0
0
0
0.0
0.0
0.00
3
1
10.00
1.440
0.086
0.000
0.000
0.00
.002
.002
0.000
0.1
0.086
0.036
0.580
14.00
2
10.00
1.440
0.086
0.000
0.000
0.00
.002
.002
0.000
1.0
0.086
0.036
0.580
14.00
0.00
3
80.00
1.580
0.030
0.000
0.000
Page
52
of
72
.002
.002
0.000
5.0
0.030
0.023
0.116
14.00
0
WATR
YEAR
10
PEST
YEAR
10
CONC
YEAR
10
1
6
11
1
DAY
RUNF
TSER
0
0
1.
E0
PRZM/
EXAMS
OUT
FILE
FOR
DIURON
ON
FL
CITRUS
WATER
COLUMN
DISSOLVED
CONCENTRATION
(
PPB)
YEAR
PEAK
96
HOUR
21
DAY
60
DAY
90
DAY
YEARLY
1948
41.250
40.840
39.670
38.640
37.560
17.810
1949
41.700
41.370
40.900
40.150
39.600
32.960
1950
63.180
62.850
61.030
59.980
59.240
45.300
1951
104.000
103.000
99.260
93.290
89.570
65.520
1952
164.000
162.000
155.000
145.000
140.000
101.000
1953
135.000
134.000
130.000
128.000
126.000
115.000
1954
145.000
144.000
141.000
135.000
132.000
113.000
1955
119.000
118.000
115.000
112.000
111.000
105.000
1956
103.000
102.000
100.000
97.490
95.600
89.990
1957
157.000
156.000
150.000
148.000
144.000
108.000
1958
127.000
126.000
124.000
120.000
118.000
111.000
1959
123.000
122.000
119.000
118.000
116.000
103.000
1960
129.000
128.000
127.000
122.000
119.000
101.000
1961
108.000
108.000
107.000
106.000
105.000
94.910
1962
96.570
95.860
94.310
91.250
89.260
82.030
1963
92.100
91.410
89.410
86.390
84.340
75.350
1964
122.000
121.000
116.000
111.000
109.000
83.840
1965
103.000
102.000
100.000
98.080
96.380
91.350
1966
92.950
92.330
90.070
87.540
86.390
82.090
1967
114.000
113.000
110.000
106.000
104.000
84.390
1968
105.000
105.000
102.000
98.400
96.480
87.980
1969
119.000
118.000
115.000
110.000
108.000
90.770
1970
92.750
92.620
92.090
90.860
89.830
83.490
1971
83.970
83.670
82.190
79.930
78.990
74.300
1972
100.000
99.460
96.810
95.270
94.030
76.820
1973
90.170
89.640
88.130
85.390
83.740
78.070
1974
86.120
85.460
83.260
79.970
77.870
71.390
1975
80.250
79.660
77.350
75.820
74.370
67.440
1976
93.180
92.430
89.710
85.900
83.650
69.710
1977
87.530
87.000
84.980
84.010
83.200
74.110
1978
73.590
73.490
73.050
72.050
71.220
63.370
1979
79.980
79.250
76.470
73.670
73.020
60.290
Page
53
of
72
1980
94.500
93.830
91.730
89.700
87.820
71.040
1981
119.000
118.000
115.000
112.000
109.000
83.030
1982
94.780
94.620
93.990
92.570
91.450
81.890
1983
114.000
113.000
109.000
103.000
99.340
78.620
SORTED
FOR
PLOTTING
PROB
PEAK
96
HOUR
21
DAY
60
DAY
90
DAY
YEARLY
0.027
164.000
162.000
155.000
148.000
144.000
115.000
0.054
157.000
156.000
150.000
145.000
140.000
113.000
0.081
145.000
144.000
141.000
135.000
132.000
111.000
0.108
135.000
134.000
130.000
128.000
126.000
108.000
0.135
129.000
128.000
127.000
122.000
119.000
105.000
0.162
127.000
126.000
124.000
120.000
118.000
103.000
0.189
123.000
122.000
119.000
118.000
116.000
101.000
0.216
122.000
121.000
116.000
112.000
111.000
101.000
0.243
119.000
118.000
115.000
112.000
109.000
94.910
0.270
119.000
118.000
115.000
111.000
109.000
91.350
0.297
119.000
118.000
115.000
110.000
108.000
90.770
0.324
114.000
113.000
110.000
106.000
105.000
89.990
0.351
114.000
113.000
109.000
106.000
104.000
87.980
0.378
108.000
108.000
107.000
103.000
99.340
84.390
0.405
105.000
105.000
102.000
98.400
96.480
83.840
0.432
104.000
103.000
100.000
98.080
96.380
83.490
0.459
103.000
102.000
100.000
97.490
95.600
83.030
0.486
103.000
102.000
99.260
95.270
94.030
82.090
0.514
100.000
99.460
96.810
93.290
91.450
82.030
0.541
96.570
95.860
94.310
92.570
89.830
81.890
0.568
94.780
94.620
93.990
91.250
89.570
78.620
0.595
94.500
93.830
92.090
90.860
89.260
78.070
0.622
93.180
92.620
91.730
89.700
87.820
76.820
0.649
92.950
92.430
90.070
87.540
86.390
75.350
0.676
92.750
92.330
89.710
86.390
84.340
74.300
0.703
92.100
91.410
89.410
85.900
83.740
74.110
0.730
90.170
89.640
88.130
85.390
83.650
71.390
0.757
87.530
87.000
84.980
84.010
83.200
71.040
0.784
86.120
85.460
83.260
79.970
78.990
69.710
0.811
83.970
83.670
82.190
79.930
77.870
67.440
0.838
80.250
79.660
77.350
75.820
74.370
65.520
0.865
79.980
79.250
76.470
73.670
73.020
63.370
0.892
73.590
73.490
73.050
72.050
71.220
60.290
0.919
63.180
62.850
61.030
59.980
59.240
45.300
0.946
41.700
41.370
40.900
40.150
39.600
32.960
0.973
41.250
40.840
39.670
38.640
37.560
17.810
1/
10
138.000
137.000
133.300
130.100
127.800
108.900
Page
54
of
72
MEAN
OF
ANNUAL
VALUES
=
80.968
STANDARD
DEVIATION
OF
ANNUAL
VALUES
=
21.004
UPPER
90%
CONFIDENCE
LIMIT
ON
MEAN
=
86.152
PRZM/
EXAMS
INPUT
FILE
FOR
DIURON
ON
NY
APPLES
***
PRZM
3.1
Input
Data
File
converted
from
PRZM
2.3
***
***
NYAPPLE.
INP,
January
15,
1998
***
***
Mannings
N
value
for
sparse
grass
under
trees
***
***
Original
file
used
Sharky
Clay
loam;
changed
to
Cabot
silt
loam;
3%
of
MLRA
***
Diuron
Columbia
Co,
New
York;
MLRA
144B
Apples,
Crab
Apples,
Quince
0.850
0.450
2
20.000
1
3
9.7
10.4
11.8
13.1
14.3
14.8
14.5
14.0
12.3
11.0
9.8
9.1
4
0.01
0.01
1.0
10.0
3.8
3
12.00
354.0
1
1
0.30
60.0
90.000
3
94
84
89
0.00
500.0
3
1
0103
0111
0101
0.74
0.01
0.01
.015
.015
.015
36
010448
150548
151248
1
010449
150549
151249
1
010450
150550
151250
1
010451
150551
151251
1
010452
150552
151252
1
010453
150553
151253
1
010454
150554
151254
1
010455
150555
151255
1
010456
150556
151256
1
010457
150557
151257
1
010458
150558
151258
1
010459
150559
151259
1
010460
150560
151260
1
010461
150561
151261
1
010462
150562
151262
1
010463
150563
151263
1
010464
150564
151264
1
010465
150565
151265
1
010466
150566
151266
1
010467
150567
151267
1
010468
150568
151268
1
010469
150569
151269
1
010470
150570
151270
1
010471
150571
151271
1
Page
55
of
72
010472
150572
151272
1
010473
150573
151273
1
010474
150574
151274
1
010475
150575
151275
1
010476
150576
151276
1
010477
150577
151277
1
010478
150578
151278
1
010479
150579
151279
1
010480
150580
151280
1
010481
150581
151281
1
010482
150582
151282
1
010483
150583
151283
1
Application
Schedule:
One
ground
appl.
@
4.0
lb/
acre,
99%
eff
w/
1%
drift
36
1
0
Diuron
Kd:
7.9;
AeSM:
T1/
2
=
372
d
200448
0
2
0.00
4.50
0.99
0.01
200449
0
2
0.00
4.50
0.99
0.01
200450
0
2
0.00
4.50
0.99
0.01
200451
0
2
0.00
4.50
0.99
0.01
200452
0
2
0.00
4.50
0.99
0.01
200453
0
2
0.00
4.50
0.99
0.01
200454
0
2
0.00
4.50
0.99
0.01
200455
0
2
0.00
4.50
0.99
0.01
200456
0
2
0.00
4.50
0.99
0.01
200457
0
2
0.00
4.50
0.99
0.01
200458
0
2
0.00
4.50
0.99
0.01
200459
0
2
0.00
4.50
0.99
0.01
200460
0
2
0.00
4.50
0.99
0.01
200461
0
2
0.00
4.50
0.99
0.01
200462
0
2
0.00
4.50
0.99
0.01
200463
0
2
0.00
4.50
0.99
0.01
200464
0
2
0.00
4.50
0.99
0.01
200465
0
2
0.00
4.50
0.99
0.01
200466
0
2
0.00
4.50
0.99
0.01
200467
0
2
0.00
4.50
0.99
0.01
200468
0
2
0.00
4.50
0.99
0.01
200469
0
2
0.00
4.50
0.99
0.01
200470
0
2
0.00
4.50
0.99
0.01
200471
0
2
0.00
4.50
0.99
0.01
200472
0
2
0.00
4.50
0.99
0.01
200473
0
2
0.00
4.50
0.99
0.01
200474
0
2
0.00
4.50
0.99
0.01
200475
0
2
0.00
4.50
0.99
0.01
200476
0
2
0.00
4.50
0.99
0.01
200477
0
2
0.00
4.50
0.99
0.01
200478
0
2
0.00
4.50
0.99
0.01
200479
0
2
0.00
4.50
0.99
0.01
200480
0
2
0.00
4.50
0.99
0.01
200481
0
2
0.00
4.50
0.99
0.01
200482
0
2
0.00
4.50
0.99
0.01
Page
56
of
72
200483
0
2
0.00
4.50
0.99
0.01
0.0
1
0.0
0.0
0.0
0.5
Cabot
Silt
loam;
Hydrologic
Group
D;
100.0
0.0
0
0
0
0
0
0
0
0
0
0.00
0.00
0.00
3
1
20.0
1.10
0.288
0.0
0.0
0.002
0.002
0.000
0.2
0.288
0.108
6.961
7.90
2
16.0
1.70
0.197
0.0
0.0
0.002
0.002
0.000
2.0
0.197
0.037
0.290
7.90
3
64.0
1.90
0.151
0.0
0.0
0.002
0.0092
0.000
2.0
0.151
0.041
0.174
7.90
0
YEAR
5
YEAR
5
YEAR
5
1
6
1
6
YEAR
PRCP
TCUM
0
0
RUNF
TCUM
0
0
RFLX
TCUM
0
0
1.0E5
EFLX
TCUM
0
0
1.0E5
ESLS
TCUM
0
0
1.0E3
RZFX
TCUM
0
0
1.0E5
PRZM/
EXAMS
OUT
FILE
FOR
DIURON
ON
NY
APPLES
WATER
COLUMN
DISSOLVED
CONCENTRATION
(
PPB)
YEAR
PEAK
96
HOUR
21
DAY
60
DAY
90
DAY
YEARLY
1948
20.130
19.830
18.960
17.410
16.610
9.222
1949
16.990
16.870
16.470
16.050
15.890
14.100
1950
28.370
28.100
27.080
26.250
25.370
20.060
1951
25.140
24.970
24.330
23.800
23.240
20.870
1952
40.610
40.260
38.960
37.750
36.460
27.980
1953
35.600
35.410
34.780
33.830
33.240
29.980
1954
42.040
41.710
40.470
38.210
37.360
30.960
1955
34.660
34.410
33.870
32.750
32.310
29.720
1956
36.600
36.420
35.780
34.630
33.650
29.940
1957
38.780
38.520
37.820
36.190
36.040
31.240
1958
38.580
38.340
37.400
36.590
35.800
31.750
1959
44.910
44.520
43.030
40.660
39.400
33.030
1960
64.810
64.160
62.230
58.040
55.570
41.840
Page
57
of
72
1961
72.190
71.750
70.450
68.330
67.250
53.580
1962
50.340
50.280
50.050
49.450
48.920
46.260
1963
49.310
49.030
48.280
47.250
46.580
41.810
1964
58.920
58.490
56.830
54.900
54.290
43.970
1965
41.510
41.460
41.310
40.820
40.380
38.450
1966
42.770
42.490
41.430
39.340
38.580
34.600
1967
48.710
48.330
46.940
44.650
43.280
35.700
1968
44.040
43.740
43.050
41.700
40.830
35.150
1969
35.890
35.670
34.830
33.510
32.830
30.710
1970
37.760
37.540
37.040
36.360
35.990
31.250
1971
38.630
38.380
37.430
35.760
35.560
31.660
1972
47.170
46.900
45.610
42.990
41.370
34.660
1973
33.020
32.980
32.820
32.410
32.060
29.380
1974
30.260
30.090
29.420
28.290
28.030
25.250
1975
39.650
39.300
38.110
37.170
36.750
29.450
1976
39.170
38.870
37.800
36.460
35.270
30.900
1977
47.090
46.730
45.380
42.960
41.520
34.310
1978
33.640
33.450
32.600
31.450
31.100
30.080
1979
32.720
32.560
31.830
30.270
29.240
27.540
1980
45.090
44.690
43.710
41.170
39.430
31.470
1981
38.610
38.410
37.660
36.630
36.210
32.130
1982
40.110
39.820
38.660
36.740
35.760
30.630
1983
50.680
50.250
49.290
46.800
45.450
35.840
SORTED
FOR
PLOTTING
PROB
PEAK
96
HOUR
21
DAY
60
DAY
90
DAY
YEARLY
0.027
72.190
71.750
70.450
68.330
67.250
53.580
0.054
64.810
64.160
62.230
58.040
55.570
46.260
0.081
58.920
58.490
56.830
54.900
54.290
43.970
0.108
50.680
50.280
50.050
49.450
48.920
41.840
0.135
50.340
50.250
49.290
47.250
46.580
41.810
0.162
49.310
49.030
48.280
46.800
45.450
38.450
0.189
48.710
48.330
46.940
44.650
43.280
35.840
0.216
47.170
46.900
45.610
42.990
41.520
35.700
0.243
47.090
46.730
45.380
42.960
41.370
35.150
0.270
45.090
44.690
43.710
41.700
40.830
34.660
0.297
44.910
44.520
43.050
41.170
40.380
34.600
0.324
44.040
43.740
43.030
40.820
39.430
34.310
0.351
42.770
42.490
41.430
40.660
39.400
33.030
0.378
42.040
41.710
41.310
39.340
38.580
32.130
0.405
41.510
41.460
40.470
38.210
37.360
31.750
0.432
40.610
40.260
38.960
37.750
36.750
31.660
0.459
40.110
39.820
38.660
37.170
36.460
31.470
0.486
39.650
39.300
38.110
36.740
36.210
31.250
0.514
39.170
38.870
37.820
36.630
36.040
31.240
0.541
38.780
38.520
37.800
36.590
35.990
30.960
Page
58
of
72
0.568
38.630
38.410
37.660
36.460
35.800
30.900
0.595
38.610
38.380
37.430
36.360
35.760
30.710
0.622
38.580
38.340
37.400
36.190
35.560
30.630
0.649
37.760
37.540
37.040
35.760
35.270
30.080
0.676
36.600
36.420
35.780
34.630
33.650
29.980
0.703
35.890
35.670
34.830
33.830
33.240
29.940
0.730
35.600
35.410
34.780
33.510
32.830
29.720
0.757
34.660
34.410
33.870
32.750
32.310
29.450
0.784
33.640
33.450
32.820
32.410
32.060
29.380
0.811
33.020
32.980
32.600
31.450
31.100
27.980
0.838
32.720
32.560
31.830
30.270
29.240
27.540
0.865
30.260
30.090
29.420
28.290
28.030
25.250
0.892
28.370
28.100
27.080
26.250
25.370
20.870
0.919
25.140
24.970
24.330
23.800
23.240
20.060
0.946
20.130
19.830
18.960
17.410
16.610
14.100
0.973
16.990
16.870
16.470
16.050
15.890
9.222
1/
10
53.152
52.743
52.084
51.085
50.531
42.479
MEAN
OF
ANNUAL
VALUES
=
31.819
STANDARD
DEVIATION
OF
ANNUAL
VALUES
=
8.159
UPPER
90%
CONFIDENCE
LIMIT
ON
MEAN
=
33.832
APPENDIX
3
ECOLOGICAL
EFFECTS
CHARACTERIZATION
TERRESTRIAL
RISK
ASSESSMENT
I.
Toxicity
to
Terrestrial
Animals
Page
59
of
72
i.
Birds
acute
and
subacute
Diuron
is
practically
non
toxic
to
slightly
toxic
to
birds
in
terms
of
acute
toxicity
(
LD50
range
of
900
>
2000
mg/
kg)
and
subacute
toxicity
(
LC50
range
of
1730
5000
ppm..
Chronic
avian
reproduction
study
was
not
submitted
by
the
registrant.
However,
avian
chronic
study
is
required
because
of
diuron's
persistency,
especially
there
is
some
concern
regarding
the
endocrine
disruption
effects
of
this
compound.
(
Table
E1,
E2)
Table
E1.
Avian
Acute
Oral
Toxicity
Species
%
ai
LD50
(
mg/
kg)
Toxicity
Category
MRID
No.
Author/
Year
Study
Classification
Northern
bobwhite
quail
(
Colinus
virginianus)
92.8
940
Slightly
toxic
50150170,
Wildlife
International,
1985
Core
Mallard
duck
(
Anas
platyrhynchos)
95
>
2000
Practical
nontoxic
00160000,
Hudson,
R.
H.
et
al,
1970
Core
1
Core
(
study
satisfies
guideline).
Supplemental
(
study
is
scientifically
sound,
but
does
not
satisfy
guideline)
.
Table
E2.
Avian
Subacute
Dietary
Toxicity
Species
%
ai
5
Day
LC50
(
ppm)
1
Toxicity
Category
MRID
No.
Author/
Year
Study
Classification
Northern
bobwhite
quail
(
Colinus
virginianus)
>
95
>
5000
Practically
nontoxic
00022923,
Hill
E.
.
R.
et
al.
1975
Core
Mallard
duck
(
Anas
platyrhynchos)
>
95
1730
Slightly
toxic
00022923,
Hill
ER
et
al.
1975
Core
Red
neck
Pheasant
>
95
>
5000
Practically
nontoxic
00022923,
Hill
ER
et
al.
1975
Core
Japanese
quail
>
95
>
5000
Practically
nontoxic
00022923,
Hill
ER
et
al.
1975
Supplemental
1
Test
organisms
observed
an
additional
three
days
while
on
untreated
feed.
II.
Exposure
and
Risk
to
Nontarget
Terrestrial
Animals
For
pesticides
applied
as
a
nongranular
product
(
e.
g.,
liquid,
dust),
the
estimated
environmental
concentrations
(
EECs)
on
food
items
following
product
application
are
compared
to
LC50
values
to
assess
risk.
The
predicted
0
day
maximum
and
mean
residues
of
a
pesticide
that
may
be
expected
to
occur
on
selected
avian
or
mammalian
food
items
immediately
following
a
direct
single
application
at
1
lb
ai/
A
are
tabulated
below.
Page
60
of
72
Table.
E3.
Estimated
Environmental
Concentrations
on
Avian
and
Mammalian
Food
Items
(
ppm)
Following
a
Single
Application
at
1
lb
ai/
A)
Food
Items
EEC
(
ppm)
Predicted
Maximum
Residue1
EEC
(
ppm)
Predicted
Mean
Residue1
Short
grass
240
85
Tall
grass
110
36
Broadleaf/
forage
plants
and
small
insects
135
45
Fruits,
pods,
seeds,
and
large
insects
15
7
1
Predicted
maximum
and
mean
residues
are
for
a
1
lb
ai/
a
application
rate
and
are
based
on
Hoerger
and
Kenaga
(
1972)
as
modified
by
Fletcher
et
al.
(
1994).
iii.
Mammals,
Acute
and
Chronic
Wild
mammal
testing
is
required
on
a
case
by
case
basis,
depending
on
the
results
of
lower
tier
laboratory
mammalian
studies,
intended
use
pattern
and
pertinent
environmental
fate
characteristics.
In
most
cases,
rat
or
mouse
toxicity
values
obtained
from
the
Agency's
Health
Effects
Division
(
HED)
substitute
for
wild
mammal
testing.
These
toxicity
values
are
reported
below.
Table
E4.
Table
Mammalian
Toxicity
Species/
Study
Duration
%
ai
Test
Type
Toxicity
Value
Affected
Endpoints
MRID
No.
laboratory
rat
or
mouse
(
Rattus
norvegicus
or
Mus
musculus)
98
Acute
oral
LD
50
LD
50(
M/
F)=
5000
/
10000
mg/
kg
mortality
00146145
Laboratory
rat
or
mouse
(
Rattus
norvegicus
or
Mus
musculus)
97.1
Reproduction
study
2
generation
NOEL/
LOEL=
250
/
1750
ppm
pup
body
weight
41957301
The
results
indicate
that
diuron
is
in
Toxicity
Category
III
to
small
mammals
on
an
acute
oral
basis.
iv.
Insects
A
honey
bee
acute
contact
study
using
the
TGAI
is
required
for
diuron
because
its
use
on
blooming
crops
such
as
cotton
and
tomato
will
result
in
honey
bee
exposure.
Results
of
this
test
are
tabulated
below.
Page
61
of
72
Table
E15.
Non
target
Insect
Acute
Contact
Toxicity
Species
%
ai
LD50
(
F
g/
bee)
Toxicity
Category
MRID
No.
Author
/
Year
Study
Classification
Honey
bee
(
Apis
mellifera)
Technical
145
Relative
non
toxic
00036935
Atkins
&
Anderson
/
1975
core
The
results
indicate
that
diuron
is
relative
non
toxic
to
bees
on
an
acute
contact
basis.
The
guideline
(
141
1)
is
fulfilled
(
MRID
00036935
).
A
honey
bee
toxicity
of
residues
on
foliage
study
using
the
typical
end
use
product
is
not
required
for
diuron
because
its
LD50
is
greater
than
0.11
ug/
bee.
AQUATIC
RISK
ASSESSMENT
i.
Toxicity
to
Freshwater
Animals
Freshwater
fish
and
invertebrates'
toxicities
are
listed
below
(
Table
E14).
Diuron
is
moderately
to
highly
toxic
to
freshwater
fish
with
LC50
values
range
0.71
14.2
mg/
l.
.
Cutthroat
trout
was
the
most
sensitive
species
tested
(
LC50
=
0.71
mg/
l
).
Studies
conducted
with
formulated
products
(
28
%
to
80
%
active
ingredient)
suggested
that
formulated
end
product
is
less
toxic
to
freshwater
fish
than
technical
end
product.
Freshwater
invertebrate
toxicity
testing
showed
that
diuron
is
moderately
to
highly
toxic
with
LC50
values
range
0.16
to
8.4
ppm.
The
amphipod
scud
is
the
most
sensitive
freshwater
invertebrate
tested
(
LC50
=
0.16
ppm).
Chronic
testing
of
freshwater
fish
establishes
NOEC
and
LOEC
(
affected
endpoint
=
reduced
average
number
of
scurvier)
of
26.4
and
61.8
F
g/
l
,
respectively.
However,
no
effect
is
observed
for
daphnid
up
to
0.2
mg/
l
(
the
highest
concentration
tested).
.
Page
62
of
72
Table
E16.
Freshwater
organisms
Acute/
chronic
Toxicity
Species/
(
Flow
through
or
Static)
%
ai
Acute
LC50/
EC5
(
ppm)
Chronic
LOEC/
NOEC
(
ppm)
Toxicity
Category
MRID
No.
Author/
Year
Study
Classification
Rainbow
trout
(
Oncorhynchus
mykiss)
static
95
1.
95
Moderately
toxic
STODIU04
EPA
/
1976
Core
Rainbow
trout
(
Oncorhynchus
mykiss)
static
80
16
Slightly
toxic
40094602
Johnson
&
Finley/
1980
Supplemental
Bluegill
sunfish
(
Lepomis
macrochirus
95
3.
2
Moderately
toxic
STODIV03
EPA
/
1976
Core
Bluegill
sunfish
(
Lepomis
macrochirus
80
>
300
Practically
nontoxic
42046001
Baer,
K.
N.
/
1992
Core
Bluegill
sunfish
(
Lepomis
macrochirus
95
2.
8
Moderately
toxic
40098001
Mayer
&
Ellersech/
1986
Core
Fathead
minnow
(
Pimephales
promelas)
98.
6
14.
2
Slightly
toxic
00141636
Brook
&
Kent/
1975
Supplemental
Cutthroat
trout
(
Oncerynchus
clarki)
95
1.
4
Moderately
toxic
40094602
Johnson
&
Finley
/
1980
Core
Cutthroat
trout
(
Oncerynchus
clarki)
95
0.
71
Highly
toxic
40098001
Mayer
&
Ellersech/
1986
Core
Lake
trout
(
Salvelinus
namaycush)
95
2.
7
Moderately
toxic
40094602
Johnson
&
Finley
/
1980
Core
Lake
trout
(
Oncerynchus
clarki)
95
1.
2
Moderately
toxic
40098001
Mayer
&
Ellersech/
1986
Core
Cohe
salmon
(
Oncorrhynchus
kisutch)
95
<
2.4
Moderately
toxic
40098001/
1986
Mayer
&
Ellersech
Core
Rainbow
trout
(
Oncorhynchus
mykiss)
static
28
23.
8
Slightly
toxic
STODIU04
EPA
1976
Core
Bluegill
sunfish
(
Lepomis
macrochirus
28
84.
0
Slightly
toxic
STODIU04
EPA/
1976
Core
..
Fathead
minnow
(
Pimephales
promelas)
98.6
0
61.8/
26.4
Reduction
of
adult
survival
00141636
EPA/
1975
(
Duluth
lab.)
Core
Waterflea
(
Daphnia
magna)
80
8
.4
Moderately
toxic
42046003
Baer,
K.
N.
1991
Core
Waterflea
(
Daphnia
duplex)
95
1.4
Moderately
toxic
40094602
Johnson
and
Finley/
1980
Core
Simocephalus
sp.
95
2.
0
Moderately
toxic
40094602
Johnson
and
Finley/
1980
Core
Scud
(
Gammarus
fasciatus)
95
0.16
Highly
toxic
40094602
Johnson
and
Finley/
1980
Core
Stonefly
95
1.
2
Moderately
toxic
40094602
Johnson
Core
Table
E16.
Freshwater
organisms
Acute/
chronic
Toxicity
Species/
(
Flow
through
or
Static)
%
ai
Acute
LC50/
EC5
(
ppm)
Chronic
LOEC/
NOEC
(
ppm)
Toxicity
Category
MRID
No.
Author/
Year
Study
Classification
1
0.44
mg/
l
is
the
lowest
concentration
tested.
2
Reproduction
effect
observed
at
1.9
mg/
l
Page
63
of
72
Waterflea
(
Daphnia
magna)
98.2
>
0.
2/
0.2
No
effect
STODIV05
EPA/
1979
Supplemental
ii.
Toxicity
to
Estuarine
and
Marine
Animals
Estuarine
and
marine
fish
and
invertebrates'
toxicities
are
listed
below
(
Table
E15
).
Diuron
is
moderately
toxic
to
both
estuarine
and
marine
fish
and
invertebrates.
Their
LC50
values
range
6.3
to
6.7
mg/
l
and
1
to
4.9
mg/
l
for
estuarine
and
marine
fish
and
invertebrate,
respectively.
Chronically,
growth
effects
were
observed
for
fish
at
0.44
mg/
l,
and
growth
and
reproduction
reduced
effects
were
noticed
at
0.27
mg/
l
for
mysids.
Table
E17.
Estuarine/
Marine
Organisms
Acute
Toxicity
Species/(
Static
or
Flow
through)
%
ai
Acut
e
LC50
/
LC50
Chronic
LOEC/
NOE
C
Toxicity
Category
MRID
No.
Author/
Year
Study
Classification
Sheepshead
minnow
(
Cyprinodon
variegatus)
99
6.
7
Moderately
toxic
41418805/
Drottar,
K.
R./
1986
Core
Striped
mullet
(
Mugil
cephalus)
95
6.3
Moderately
toxic
40228401
F.
L.
Mayer
1986
Supplemental
Sheepshead
Minnow
(
Cyprinodon
variegatus)
96.
8
0.44/<
0.441
Weight
and
survival
42312901/
Ward
&
Boeri
/
1992
Supplemental
Eastern
oyster
(
shell
deposition
or
embryo
larvae)
(
Crassostrea
virginica)
96.
8
4.
9
Moderately
toxic
42217201Ward
&
Boer/
1991
Core
Brown
shrimp
(
Penaeus
aztecus)
95
>
1
Moderately
toxic
40228401
F.
L.
Mayer
/
1986
Supplemental
Mysid
(
Americamysis
bahia)
96.
8
0.56/
0.272
Length,
#
of
youngs
produced
42500601
Ward
&
Boeri
Sheepshead
Minnow
(
Cyprinodon
variegatus)
Page
64
of
72
Page
65
of
72
NON
TARGET
PLANT
RISK
ASSESSMENT
i.
Terrestrial
Terrestrial
plant
testing
(
seedling
emergence
and
vegetative
vigor)
is
required
for
herbicides
that
have
terrestrial
non
residential
outdoor
use
patterns
and
that
may
move
off
the
application
site
through
volatilization
(
vapor
pressure
>
1.0
x
10
5mm
Hg
at
25oC)
or
drift
(
aerial
or
irrigation)
and/
or
that
may
have
endangered
or
threatened
plant
species
associated
with
the
application
site.
For
seedling
emergence
and
vegetative
vigor
testing
the
following
plant
species
and
groups
should
be
tested:
(
1)
six
species
of
at
least
four
dicotyledonous
families,
one
species
of
which
is
soybean
(
Glycine
max),
and
the
second
of
which
is
a
root
crop,
and
(
2)
four
species
of
at
least
two
monocotyledonous
families,
one
of
which
is
corn
(
Zea
mays).
The
registrant
has
conducted
the
terrestrial
Tier
II
plant
study
and
submitted
their
results.
Tier
II
tests
measure
the
response
of
plants,
relative
to
a
control,
and
five
or
more
test
concentrations.
Results
of
Tier
II
toxicity
testing
on
the
technical
material
are
tabulated
below.
Table
E
1.
Nontarget
terrestrial
plant
seedling
emergence
toxicity
(
Tier
II)
Species
%
ai
EC25/
EC05
(
lbs
ai/
A)
EndpointAffecte
MRID
No.
Author/
Year
Study
Classification
Monocot
Corn
96.8
5.7
/
0.75
Shoot
height
42398501/
McKelvey
&
Kuratle/
1992
Core
Monocot
sorghum
96.8
0.81
/
0.75
Shoot
height
42398501/
McKelvey
&
Kuratle/
1992
Core
Monocot
onion
97.3
0.099
/
0.089
Shoot
dry
weight
44114301/
Heldreth
&
McKelvey
Core
Monocot
wheat
97.3
1.05
/
0.38
Shoot
dry
weight
44113401/
Heldreth
&
McKelvey/
1996
Core
Dicot
Root
Crop
(
pea)
96.8
>
12
/
12
Shoot
height
42398501/
McKelvey
&
Kuratle/
1992
Core
Dicot
Soybean
96.8
<
12
/
12
Shoot
height
42398501/
McKelvey
&
Kuratle/
1992
Core
Dicot
Cucmber
96.8
0.34
/
0.19
Shoot
height
42398501/
McKelvey
&
Kuratle/
1992
Core
Dicot
Rape
97.3
0.094
/
0.047
Shoot
dry
weight
44113401/
Heldreth
&
McKelvey/
1996
Core
Dicot
Sugar
beet
97.3
0.092
/
0.047
Shoot
dry
weight
44113401/
Heldreth
&
McKelvey/
1996
Core
Dicot
Tomato
97.3
0.08
/
0.047
Shoot
dry
weight
44113401/
Heldreth
&
McKelvey/
1996
Core
For
Tier
II
seedling
emergence
tomato
is
the
most
sensitive
dicot
and
onion
is
the
most
sensitive
monocot.
The
guideline
(
123
1)
is
fulfilled/
not
fulfilled
(
MRID
44113401,
42398501).
Page
66
of
72
Table
E2.
Nontarget
Terrestrial
Plant
Vegetative
Vigor
Toxicity
(
Tier
II)
Species
%
ai
EC25/
EC05
(
lbs
ai/
A)
Endpoint
Affected
MRID
No.
Author/
Year
Study
Classification
Monocot
Corn
96.8
0.39
/
0.19
Shoot
dry
weight
42398501/
McKelvey
&
Kuratle/
1992
Core
Monocot
Onion
97.3
0.148
/
0.094
Shoot
dry
weigh
44113401/
Heldreth
&
McKelvey/
1996
Core
Monocot
Sorghum
97.3
0.075
/
0.012
Shoot
dry
weight
44113401/
Heldreth
&
McKelvey/
1996
Core
Wheat
0.021
/
0.002
Sho1ot
dry
weight
44113401/
Heldreth
&
McKelvey/
1996
Core
Dicot
Root
Crop
(
Pea)
97.3
0.014
/
0.003
Shoot
dry
weight
44113401/
Heldreth
&
McKelvey/
1996
Core
Dicot
Soybean
96.8
0.012
/
0.002
Shoot
dry
weight
42398501/
McKelvey
&
Kuratle/
1992
Core
Dicot
Rape
97.3
0.033
/
0.012
Shoot
dry
weight
44113401/
Heldreth
&
McKelvey/
1996
Core
Dicot
Cucumber
96.8
0.005
/
0.005
Shoot
dry
weight
42398501/
McKelvey
&
Kuratle/
1992
Core
Dicot
Sugar
beet
96.8
0.009
/
0.005
Shoot
dry
weight
42398501/
McKelvey
&
Kuratle/
1992
Core
Dicot
Tomato
96.8
0.002
/
0.001
Shoot
dry
weight
42398501/
McKelvey
&
Kuratle/
1992
Core
For
Tier
II
vegetative
vigor
tomato
is
the
most
sensitive
dicot
and
wheat
is
the
most
sensitive
monocot.
The
guideline
(
123
1)
is
fulfilled/
not
fulfilled
(
MRID
42398501,
44113401
).
II.
Exposure
and
Risk
to
Nontarget
Plants
i.
Dry
and
Semi
aquatic
Areas
Terrestrial
plants
inhabiting
dry
and
semi
aquatic
areas
may
be
exposed
to
pesticides
from
runoff,
spray
drift
or
volatilization.
Semi
aquatic
areas
are
those
low
lying
wet
areas
that
may
be
dry
at
certain
times
of
the
year.
EFED's
runoff
scenario
is:
(
1)
based
on
a
pesticide's
water
solubility
and
the
amount
of
pesticide
present
on
the
soil
surface
and
its
top
one
inch,
(
2)
characterized
as
"
sheet
runoff"
(
one
treated
acre
to
an
adjacent
acre)
for
dry
areas,
(
3)
characterized
as
"
channelized
runoff"
(
10
treated
acres
to
a
distant
low
lying
acre)
for
semi
aquatic
areas,
and
(
4)
based
on
%
runoff
values
of
0.01,
0.02,
and
0.05
for
water
solubility
of
<
10
ppm,
10
100
ppm,
and
>
100
ppm,
respectively.
Spray
drift
exposure
from
ground
application
is
assumed
to
be
1%
of
the
application
rate.
Spray
drift
from
aerial,
airblast,
forced
air,
and
chemigation
applications
is
assumed
to
be
5%
of
the
application
rate.
EECs
are
calculated
for
the
following
application
methods:
(
1)
unincorporated
ground
applications,,
and
(
2)
aerial,
airblast,
forced
air,
and
chemigation
applications.
Formulas
for
calculating
EECs
for
dry
areas
adjacent
to
treatment
sites
and
EECs
for
semi
aquatic
areas
are
in
an
addendum.
Estimated
environmental
concentrations
for
dry
and
semi
aquatic
areas
are
tabulated
below.
Page
67
of
72
Table
E
3.
Estimated
Environmental
Concentrations
(
lbs
ai/
A)
For
Dry
and
Semi
Aquatic
Areas
for
a
Single
Application
Site/
Application
Method/
Rate
of
Application
in
lbs
ai/
A
Minimum
Incorporatio
n
Depth
(
cm)
Runoff
Value
Sheet
Runoff
(
lbs
ai/
A)
Channelized
Runoff
(
lbs
ai/
A)
Drift
(
lbs
ai/
A)
Total
Loading
to
Adjacent
Area
(
Sheet
Runoff
Drift)
1/
Total
Loading
to
Semi
aquatic
Area
(
Channel
Run
off+
Drift)
2/
Railroad
Unincorporated
Ground
12
0
0.05
0.60
6.00
0.12
0.72
6.12
Grape
Unincorporated
Ground
9.6
0
0.05
0.48
4.80
0.10
0.58
4.90
Citrus
Unincorporated
Ground
6.4
0
0.05
0.32
3.20
0.06
0.38
3.26
Alfalfa/
Sugarcane/
Grass
seeds
Unincorporated
Ground
3.2
0
0.05
0.16
1.60
0.03
0.19
1.63
Cotton
Unincorporated
Ground
1.6
0
0.05
0.08
0.80
0.02
0.10
0.82
Railroad/
Right
of
way
Aerial,
12
0
0.05
0.36
3.60
0.60
0.96
4.20
Citrus
Airblast
9.6
0
0.05
0.29
2.90
0.48
0.77
3.38
Alfalfa/
Sugarccane
Aerial,
3.2
0.05
0.10
1.00
0.16
0.26
1.16
Cotton
Aerial
1.6
0
0.05
0.05
0.50
0.08
0.13
0.58
Table
E
3.
Estimated
Environmental
Concentrations
(
lbs
ai/
A)
For
Dry
and
Semi
Aquatic
Areas
for
a
Single
Application
Site/
Application
Method/
Rate
of
Application
in
lbs
ai/
A
Minimum
Incorporatio
n
Depth
(
cm)
Runoff
Value
Sheet
Runoff
(
lbs
ai/
A)
Channelized
Runoff
(
lbs
ai/
A)
Drift
(
lbs
ai/
A)
Total
Loading
to
Adjacent
Area
(
Sheet
Runoff
Drift)
1/
Total
Loading
to
Semi
aquatic
Area
(
Channel
Run
off+
Drift)
2/
Page
68
of
72
1/
Dry
area
EEC
/
Seeding
Emergence
EC25,
2/
Semi
aquatic
EEC
/
Seeding
Emergence
EC25
The
EC25
value
of
the
most
sensitive
species
in
the
seedling
emergence
study
is
compared
to
runoff
and
drift
exposure
to
determine
the
risk
quotient
(
EEC/
toxicity
value).
The
EC25
value
of
the
most
sensitive
species
in
the
vegetative
vigor
study
is
compared
to
the
drift
exposure
to
determine
the
acute
risk
quotient.
The
NOEC
or
EC05
(
if
NOEC
is
unavailable)
value
of
the
most
sensitive
species
in
the
seedling
emergence
study
is
compared
to
runoff
and
drift
exposure
to
determine
the
endangered
species
risk
quotient.
The
NOEC
or
EC05
value
of
the
most
sensitive
species
in
the
vegetative
vigor
study
is
compared
to
the
drift
exposure
to
determine
the
endangered
species
risk
quotient.
EECs
and
acute
(
endangered
species)
risk
quotients
for
terrestrial
plants
based
on
a
single
application
are
tabulated
below.
Risk
quotients
based
on
seedling
emergence
on
NOEC
or
EC05
ranged
from
5
to
48
for
dry
area
and
from
29
to
306
for
semi
aquatic
areas.
RQ
values
were
20
and
100
for
ground
application
and
aerial
application,
respectively
(
Table
9).
Thus
a
single
application,
plant
acute
high
risk
and
endangered
species
levels
of
concern
are
exceeded
for
terrestrial
plants
in
dry
areas
and
semi
aquatic
area
at
a
registered
maximum
single
application
rate
equal
to
or
above
1.6
lb/
A.
The
results
also
implicate
that
for
multiple
applications,
plant
acute
high
risk
and
endangered
species
levels
of
concerns
will
exceeded
for
terrestrial
plants
in
both
dry
and
semiaquatic
areas
at
a
registered
minimum
label
rate.
Currently,
EFED
does
not
perform
chronic
risk
assessments
for
terrestrial
plants
ii.
Aquatic
Plants
Aquatic
plant
testing
is
required
for
diuron
that
has
outdoor
non
residential
terrestrial
uses
that
may
move
off
site
by
runoff
(
solubility
>
10
ppm
in
water),
by
drift
(
aerial),
or
that
is
applied
directly
to
aquatic
use
sites
(
except
residential).
The
registrant
has
chose
to
conduct
Aquatic
Tier
II
studies.
For
Aquatic
Tier
II
studies,
the
following
species
should
be
tested
at
Tier
II:
Pseudokirchneria
subcapitata,
Lemna
gibba,
Skeletonema
costatum,
Anabaena
flos
aquae,
and
freshwater
diatom.
Results
of
Tier
II
toxicity
testing
on
the
technical
material
are
tabulated
below.
Table
E
4.
Nontarget
Aquatic
Plant
Toxicity
(
Tier
II)
Species
%
ai
EC50/
(
ppb)
MRID
No.
Author/
Year
Study
Classification
Vascular
Plants
Table
E
4.
Nontarget
Aquatic
Plant
Toxicity
(
Tier
II)
Species
%
ai
EC50/
(
ppb)
MRID
No.
Author/
Year
Study
Classification
Page
69
of
72
Duckweed
Lemna
gibba
Nonvascular
Plants
Green
algae
Selenastrum
capricornutum
96.8
2.4
42218401/
Blasberg
&
Hicks/
1991
Core
Green
algae
Dunaliella
tertiolecta
95
20
40228401/
Mayer,
F.
L./
1986
Supplemental
Green
algae
Chlamydomonas
sp.
95
37
40228401/
Mayer,
F.
L./
1986
Supplemental
Green
algae
Chlorococcum
sp.
95
10
40228401/
Mayer,
F.
L./
1986
Supplemental
Green
algae
Chlorella
sp.
95
19
40228401/
Mayer,
F.
L./
1986
Supplemental
Green
algae
Neochloris
sp.
95
28
40228401/
Mayer,
F.
L./
1986
Supplemental
Marine
diatom
Skeletonema
costatum
_
_
_
_
Marine
diatom
Phaeodactylum
tricornutum
95
10
40228401/
Mayer,
F.
L./
1986
Supplemental
Freshwater
diatom
Navicula
pelliculosa
_
_
_
_
Freshwater
diatom
Thallssiosira
fluviatilus
95
95
40228401/
Mayer,
F.
L./
1986
Supplemental
Blue
green
algae
Anabaena
flos
aquae
_
_
_
_
Algae
Monochrysis
lutheri
95
18
40228401/
Mayer,
F.
L./
1986
Supplemental
Algae
Isochrysis
galbana
95
10
40228401/
Mayer,
F.
L./
1986
Supplemental
Algae
Cyclotella
nana
_
_
_
_
Algae
Achnanthes
brevipes
95
24
40228401/
Mayer,
F.
L./
1986
Supplemental
Algae
Navicula
incerta
95
93
40228401/
Mayer,
F.
L./
1986
Supplemental
Algae
Stauroneis
amphoroides
95
31
40228401/
Mayer,
F.
L./
1986
Supplemental
Algae
Amphora
exigua
95
31
40228401/
Mayer,
F.
L./
1986
Supplemental
Table
E
4.
Nontarget
Aquatic
Plant
Toxicity
(
Tier
II)
Species
%
ai
EC50/
(
ppb)
MRID
No.
Author/
Year
Study
Classification
Page
70
of
72
Algae
Nitzschia
closterium
sp
95
50
40228401/
Mayer,
F.
L./
1986
Supplemental
The
Tier
II
results
indicate
that
only
the
study
with
Green
algae
Selenastrum
capricornutum
toxicity
study
is
acceptable.
All
other
studies
submitted
is
not
acceptable
because
the
plant
species
not
recommended
species
(
Table
E4).
ii.
Aquatic
Plants
Exposure
to
nontarget
aquatic
plants
may
occur
through
runoff
or
spray
drift
from
adjacent
treated
sites
or
directly
from
such
uses
as
aquatic
weed
or
mosquito
larvae
control.
An
aquatic
plant
risk
assessment
for
acute
high
risk
is
usually
made
for
aquatic
vascular
plants
from
the
surrogate
duckweed
Lemna
gibba.
Non
vascular
acute
high
aquatic
plant
risk
assessments
are
performed
using
either
algae
or
a
diatom,
whichever
is
the
most
sensitive
species.
An
aquatic
plant
risk
assessment
for
acute
endangered
species
is
usually
made
for
aquatic
vascular
plants
from
the
surrogate
duckweed
Lemna
gibba.
To
date
there
are
no
known
non
vascular
plant
species
on
the
endangered
species
list.
Runoff
and
drift
exposure
is
computed
from
either
GENEEC
or
PRIZM3/
EXAMS
2.95
(
GENEEC
II
used).
The
risk
quotient
is
determined
by
dividing
the
pesticide's
initial
or
peak
concentration
in
water
by
the
plant
EC50
value.
Based
on
an
EC50
value
for
green
algae
(
EC50
=
0.0021
ppm)
and
EEC
value
ranged
from
0.022
mg/
l
to
0.412
ppm,
acute
risk
quotients
for
non
vascular
plants
are
from
9.58
to
171.67.
Based
on
these
RQ
values,
the
results
indicate
that
plant
acute
high
risk
and
endangered
species
levels
of
concern
are
exceeded
for
nonvascular
plants
at
registered
minimum
label
rate
of
1.6
lbs.
ai/
A.(
Table
10).
However,
acute
RQ
for
vascular
aquatic
plant
and
endanger
species
ane
not
calculated
because
lack
of
duckweed
(
Lemna
gibba)
toxicity
data.
Currently,
EFED
does
not
perform
assessments
for
chronic
risk
to
aquatic
plants.
Appendix
4
Environmental
Fate
and
Transport
Studies
Reviewed
(
4)
MRID
No.
41418804
(
161
1)
Hawkins,
D.
R.
et
al.
1988.
The
hydrolytic
stability
of
14C
diuron,
21
April
1988.
Huntingdon
Research
Center,
Report
No.
HRC/
DPT
177/
88698.
EFGWB
90
0737.
(
5)
MRID
No.
41418805
(
161
2)
Hawkins,
D.
R.
et
al.
1988.
The
photodegradation
of
14C
diuron
in
water,
30
August
1988.
Huntingdon
Research
Center,
Report
No.
HRC/
DPT
177/
881179.
EFGWB
90
0737.
(
6)
MRID
No.
41719302
(
161
3)
Stevenson,
I.
E.
1990b.
Photodegradation
of
[
phenyl(
U)
14C]
diuron
on
soil
under
artificial
sunlight.
Laboratory
Project
ID:
AMR
771
87.
Unpublished
study
performed
by
Biospherics,
Inc.,
Rockville,
MD,
and
Cambridge
Analytical
Associates,
Boston,
MA,
and
submitted
by
E.
I.
du
Pont
de
Nemours
and
Company,
Wilmington,
DE.
Page
71
of
72
(
7)
MRID
No.
4179303
(
162
1)
Hawkins,
D.
R.,
D.
Kirkpatrick,
D.
Shaw,
and
S.
C.
Chan.
1990.
The
metabolism
of
[
phenyl(
U)
14C]
diuron
in
Keyport
silt
loam
soil
under
aerobic
conditions.
Du
Pont
Report
No.
AMR
1202
88.
Huntingdon
Research
Center
Report
No.
HRC/
DPT
189/
891860.
Unpublished
study
performed
by
Huntingdon
Research
Centre,
Huntingdon,
Cambridgeshire,
England,
and
submitted
by
E.
I
du
Pont
de
Nemours
&
Company,
Inc.,
Wilmington,
DE.
(
8)
MRID
No.
41418806
(
162
2)
Yu,
W.
C.
1988.
Anaerobic
soil
metabolism
of
[
phenyl(
U)
14C]
diuron,
30
August
1988.
Cambridge
Analytical
Associates.
(
9)
MRID
No.
44221001
(
162
3)
Hausmann,
S.
M.
1992.
Anaerobic
aquatic
metabolism
of
[
phenyl(
U)
14C]
diuron.
Laboratory
Project
ID:
AMR
2067
91.
Unpublished
study
performed
and
submitted
by
E.
I.
du
Pont
de
Nemours
and
Company,
Wilmington,
DE.
(
10)
MRID
No:
44221002
(
162
4)
Hausmann,
S.
M.,
and
G.
M.
Kraut.
1992.
Aerobic
aquatic
metabolism
of
[
phenyl(
U)
14C]
diuron.
Laboratory
Project
ID:
AMR
2066
91.
Unpublished
study
performed
and
submitted
by
E.
I.
du
Pont
de
Nemours
and
Company,
Wilmington,
DE.
(
11)
MRID
No.
444490501
(
163
1)
Bramble,
F.
Q.,
F.
D.
Behmke,
and
G.
I.
Norwood.
1998.
Batch
equilibrium
(
adsorption/
desorption)
of
14C
diuron,
fenuron,
and
N'(
3
chlorophenyl)
N,
N
dimethylurea
on
soil.
DuPont
Project
ID:
AMR
4584
97.
Unpublished
study
performed
and
submitted
by
E.
I.
du
Pont
de
Nemours
and
Company,
Wilmington,
DE.
(
12)
MRID
No.
444865001
(
164
1)
Bramble,
F.
Q.
Jr.,
F.
D.
Behmke,
R.
S.
Frizzel.,
and
G.
I.
Norwwod.
July
2,
1998.
Field
soil
dissipation
of
diuron
following
application
of
Karmex
DF
herbicide.
Performed
by
E.
I.
du
pont
de
Nemorous
and
Company,
Wilmington,
DE
19880
0402.
Sponsored
by
E.
I.
du
pont
de
Nemorous
and
Company,
Wilmington,
DE
19898.
Report
No.
AMR
4383
97.
(
10)
MRID
No.
44865001
(
164
1)
Tweedy,
B.
G.
June
28,
1999.
Field
soil
dissipation
of
diuron
following
application
of
Karmex
DF
herbicide.
Performed
by
ABC
Laboratories,
Columbia,
MO.
Sponsored
by
Griffin
LLC,
P.
O.
Box
1847,
Valdosta,
GA
31603
1847.
Project
Identification
No.
GP98
084
(
7B)
MRID
No:
44386701
Page
72
of
72
| epa | 2024-06-07T20:31:43.509717 | regulations | {
"license": "Public Domain",
"url": "https://downloads.regulations.gov/EPA-HQ-OPP-2002-0249-0005/content.txt"
} |
EPA-HQ-OPP-2002-0249-0006 | Supporting & Related Material | "2002-10-01T04:00:00" | null | UNITED
STATES
ENVIRONMENTAL
PROTECTION
AGENCY
WASHINGTON,
D.
C.
20460
OFFICE
OF
PREVENTION,
PESTICIDES
AND
TOXIC
SUBSTANCES
PC
Code:
035505
DP
Barcode:
D275046
MEMORANDUM
August
27,
2001
SUBJECT:
Drinking
Water
Assessment
for
diuron
and
its
degradates
TO:
Diana
Locke
Reregistration
Actions
Branch
II
Health
Effects
Division
(
7509C)
FROM:
Ibrahim
Abdel
Saheb/
Agronomist
Environmental
Risk
Branch
II
Environmental
Fate
and
Effects
Division
(
7507C)
PEER
REVIEW:
Sid
Abel/
Environmental
Scientist
Environmental
Risk
Branch
II
Environmental
Fate
and
Effects
Division
(
7507C)
THRU:
Tom
Bailey,
Branch
Chief
Environmental
Risk
Branch
II
Environmental
Fate
and
Effects
Division
(
7507C)
CONCLUSIONS
The
memorandum
transmits
the
estimated
drinking
water
concentrations
for
use
in
the
human
health
risk
assessment.
Griffin
Label
(
EPA
Reg.
No.
1812
362)
was
used
to
determine
the
estimated
concentrations.
The
Tier
II
screening
models
PRZM1
and
EXAMS2
with
the
Index
2
Reservoir
and
Percent
Crop
Area
adjustment
was
used
to
determine
estimated
surface
water
concentrations
of
diuron
and
its
degradates
dichlorophenylmethylurea
(
DCPMU);
dichlorophenylurea
(
DCPU);
3,4
dichloraniline
(
3,4
DCA);
and
N'(
3
chlorophenyl)
N
Ndimethylurea
(
mCPDMU).
The
Screening
Concentration
in
Groundwater
(
SCI
GROW3)
model
was
used
to
estimate
groundwater
concentrations
for
Diuron
and
its
degradates.
Modeling
results
are
shown
in
Table
1.
Table
1.
Estimated
environmental
concentrations
in
surface
and
groundwater
for
diuron
and
its
degradates
use
on
citrus.
Toxicity
end
point
model
EECs
(
F
g/
L)
use(
s)
modeled
PCA
Diuron
DCPMU
DCPU
3,4
DCA
mCPDMU
one
application
of
diuron
on
citrus
@
9.6
lb
ai/
acre,
ground
application
Default
(
0.87)
Surface
water/
peak
1083
48.2
1.91
0.05
58.9
Surface
water/
1
10
year
average)
251
8.44
0.33
0.003
13.5
Surface
water/
mean
of
annual
values)
146
5.98
0.24
0.002
9.22
Groundwater/
(
peak
and
long
term
average)
6.52
2.50
0.09
2X10
4
0.30
The
IR
PCA
modeling
results
indicate
that
diuron
and
its
degradates
have
the
potential
to
contaminate
surface
waters
by
runoff
in
areas
with
large
amounts
of
annual
rainfall.
The
degradate
3,4
DCA
is
commonly
seen
in
surface
water
in
areas
with
high
diuron
and
propanil
usage,
however,
EFED
has
received
no
guideline
studies
on
the
environmental
fate
and
transport
of
3,4
DCA
or
other
degradate
of
diuron.
EFED
believes
that
additional
studies
are
needed
to
fully
understand
both
the
fate
and
transport
of
these
compounds
in
the
environment.
Modeling
results
were
higher
EECs
than
data
from
existing
diuron
surface
water
monitoring
data
targeted
to
the
pesticide
use
area.
Modeling
values
where
several
magnitude
(
ranging
from
9
100
times)
higher
than
monitoring
data.
Major
degradates
that
were
determined
by
HED
to
be
of
toxicological
concern
include:
dichlorophenylmethylurea
(
DCPMU),
3
dichlorophenylurea
(
DCPU),
3,4
dichloroaniline
(
3,4
DCA),
and
N'(
3
chlorophenyl)
N
N
dimethylurea
(
mCPDMU)].
Because
the
EFED
lacks
complete
environmental
fate
data
(
such
as
the
aerobic
aquatic
and
anaerobic
aquatic
studies)
on
any
of
these
degradates,
this
memorandum
addresses
the
estimated
environmental
concentrations
(
EEC's)
for
surface
and
groundwater
based
on
half
lives
that
were
calculated
on
cumulative
residues.
Usage
map
for
diuron4
is
attached.
Surface
Water
Monitoring
The
EFED
has
targeted,
but,
limited
monitoring
data
on
the
concentrations
of
diuron
and
its
degradates
in
surface
water.
A
study
on
the
occurrence
of
cotton
herbicides
and
insecticides
in
Playa
lakes
of
the
high
plains
of
western
Texas
concluded
that
diuron
was
the
major
pesticide
detected
in
water
samples
collected
from
32
lakes
with
a
mean
concentration
of
2.7
ppb.
Diuron
metabolites
(
DCPMU,
DCPU,
and
3,4
DCA)
were
found
in
71%
of
the
samples
analyzed.
The
mean
concentrations
of
these
metabolites
were
0.45
ppb
for
DCPMU,
0.31
ppb
for
3,4
DCA,
and
0.2
ppb
for
DCPU5.
In
this
study,
water
samples
were
taken
within
two
days
after
diuron
application
to
cotton
in
the
region.
Diuron
usage
on
cotton
in
this
part
of
the
state
reached
an
average
of
$
1379
lb
ai/
mile2/
yr.
Even
though,
the
monitoring
of
diuron
concentrations
from
use
on
Cotton
in
this
part
of
the
state
is
an
example
of
targeted
study,
the
frequency
of
surface
water
sampling
and
the
length
of
sampling
period
were
insufficient
to
satisfy
the
temporal
and
spatial
requirements
for
regulatory
purposes.
This
study
has
limited
use
in
a
national
assessment
because
we
do
not
expect
western
Texas
to
be
one
of
the
most
vulnerable
use
areas
for
runoff.
However,
because
the
samples
were
taken
within
two
days
after
application,
the
results
may
represent
a
lower
bound
of
possible
peak
concentrations
that
could
occur
in
drinking
water
in
that
area.
The
US
Geological
Survey
(
USGS)
National
Water
Quality
Assessment
Program
(
NAWQA)
collected
1420
surface
water
samples
4
from
62
agricultural
stream
sites
during
the
period
from
1992
1998.
One
to
two
samples
was
collected
each
month
during
periods
when
pesticide
transport
in
the
streams
was
expected
to
be
low
throughout
the
year.
At
most
sites,
the
sampling
frequency
was
increased
to
1
to
3
samples
per
week
during
periods
when
elevated
levels
of
pesticides
were
expected
in
the
streams.
Diuron
was
detected
in
7.32%
of
the
samples
(
detection
limit
=
0.05
ppb)
with
concentration
of
0.13
ppb
in
95%
of
samples.
Diuron
maximum
concentration
was
13
ppb
(
estimated
concentration)
6.
Modeling
Tier
II
surface
water
modeling
was
done
using
the
Index
Reservoir
(
IR)
and
Percent
Crop
Area
(
PCA)
modifications
to
PRZM
and
EXAMS.
The
index
reservoir
represents
a
potential
vulnerable
drinking
water
source
from
a
specific
area
(
Illinois)
with
specific
cropping
patterns,
weather,
soils,
and
other
factors.
The
PCA
is
a
generic
watershed
based
adjustment
factor
which
represent
the
portion
of
a
watershed
planted
to
a
crop
or
crops
and
will
be
applied
to
pesticide
concentrations
estimated
for
the
surface
water
component
of
the
drinking
water
exposure
assessment
using
PRZM/
EXAMS
with
the
index
reservoir
scenario7.
The
IR
PCA
PRZM/
EXAMS
model
use
and
fate
input
parameters
for
diuron
and
its
degradates
in
surface
water
are
shown
in
Tables
2
6.
The
IR
PC
PRZM/
EXAMS
model
input
and
output
files
for
diuron
and
its
degradates
are
shown
in
Appendix
I.
5
Table
2:
IR
PC
PRZM/
EXAMS
input
parameters
for
diuron.
Input
variable
Input
value
&
calculations
Source/
Quality
of
data
Crop
name
citrus
label
(
EPA
Reg.
No.
1812
362).
application
rate
(
lb
ai/
acre)
9.6
label
(
EPA
Reg.
No.
1812
362).
Application
efficiency
0.99
IR
PC
Guidance7
Spray
drift
fraction
0.064
IR
PC
Guidance
Application
method
ground
label
(
EPA
Reg.
No.
1812
362).
DWRATE
(
day
1)
0.002
MRID#
41719303;
Input
parameters
guidance8
DSRATE
(
day
1)
0.002
MRID#
41719303;
Input
parameters
guidance
Kd
(
mL/
g)
14
MRID#
44490501;
Input
parameters
guidance
Henry
(
atm.
m3/
mole)
2.2X10
10
(
calculated)
Product
Chemistry
chapter
for
HED
RED,
2001.
KBACW
(
h
1)
7.6X10
5
No
aerobic
aquatic
data
is
available,
the
aerobic
soil
met.
t
½
was
multiplied
by
0.5.
MRID#
41719303.
Input
parameters
guidance.
KBACS
(
h
1)
5.8X10
5
No
anaerobic
aquatic
data
is
available,
the
anaerobic
soil
met.
t
½
was
multiplied
by
0.5.
MRID#
41418806.
Input
parameters
guidance.
KDP
(
h
1)
6.7X10
4
MRID#
41418805;
Input
parameters
guidance.
KBH,
KNH,
KAH
(
h
1)
0
(
stable)
MRID#
41418804.
6
KPS
(
mL/
g)
14
MRID#
44490501;
Input
parameters
guidance.
MWT
(
g/
mole)
233.1
The
MERCK
INDEX9
Solubility
@
25
0C
(
ppm)
420
Product
Chemistry
chapter
for
HED
RED,
2001;
Input
parameters
guidance.
Vapor
pressure
(
torr)
2.0X10
7
Product
Chemistry
chapter
for
HED
RED,
2001.
7
Table
3:
IR
PC
PRZM/
EXAMS
input
parameters
for
DCPMU.
Input
variable
Input
value
&
calculations
Source/
Quality
of
data
Crop
name
citrus
label
(
EPA
Reg.
No.
1812
362).
application
rate
(
lb
ai/
acre)
2.03
label
(
EPA
Reg.
No.
1812
362).
An
equivalent
value
based
on
maximum
conversion
of
diuron
to
degradates
and
the
molecular
weight
ratio
adjustment.
Application
efficiency
0.99
IR
PC
Guidance7
Spray
drift
fraction
0.064
IR
PC
Guidance
Application
method
ground
label
(
EPA
Reg.
No.
1812
362).
DWRATE
(
day
1)
0.009
MRID#
41719303;
Input
parameters
guidance8
DSRATE
(
day
1)
0.009
MRID#
41719303;
Input
parameters
guidance
Kd
(
mL/
g)
for
diuron:
14
MRID#
44490501;
Input
parameters
guidance
Henry
(
atm.
m3/
mole)
for
diuron:
2.2X10
10
(
calculated)
Product
Chemistry
chapter
for
HED
RED,
2001.
KBACW
(
h
1)
for
diuron:
0.0003
No
aerobic
aquatic
data
is
available,
diruon
t
½
was
multiplied
by
3,
MRID#
41719303.
Input
parameters
guidance.
KBACS
(
h
1)
for
diuron:
0.002
No
anaerobic
aquatic
data
is
available,
the
anaerobic
soil
met.
t
½
was
multiplied
by
0.5.
MRID#
41418806.
Input
parameters
guidance.
KDP
(
h
1)
for
diuron:
0.0007
MRID#
41418805;
Input
parameters
guidance.
KBH,
KNH,
KAH
(
h
1)
for
diuron:
0
(
stable)
MRID#
41418804.
KPS
(
mL/
g)
for
diuron:
14
MRID#
44490501;
Input
parameters
guidance.
MWT
(
g/
mole)
233.1
The
MERCK
INDEX9
Solubility
@
25
0C
(
ppm)
for
diuron:
420
Product
Chemistry
chapter
for
HED
RED,
2001;
Input
parameters
guidance.
8
Vapor
pressure
(
torr)
for
diuron:
2.0X10
7
Product
Chemistry
chapter
for
HED
RED,
2001.
Table
4:
IR
PC
PRZM/
EXAMS
input
parameters
for
DCPU.
Input
variable
Input
value
&
calculations
Source/
Quality
of
data
Crop
name
citrus
label
(
EPA
Reg.
No.
1812
362).
application
rate
(
lb
ai/
acre)
0.08
label
(
EPA
Reg.
No.
1812
362).
An
equivalent
value
based
on
maximum
conversion
of
diuron
to
degradates
and
the
molecular
weight
ratio
adjustment.
Application
efficiency
0.99
IR
PC
Guidance7
Spray
drift
fraction
0.064
IR
PC
Guidance
Application
method
ground
label
(
EPA
Reg.
No.
1812
362).
DWRATE
(
day
1)
0.009
MRID#
41719303;
Input
parameters
guidance8
DSRATE
(
day
1)
0.009
MRID#
41719303;
Input
parameters
guidance
Kd
(
mL/
g)
for
diuron:
14
MRID#
44490501;
Input
parameters
guidance
Henry
(
atm.
m3/
mole)
for
diuron:
2.2X10
10
(
calculated)
Product
Chemistry
chapter
for
HED
RED,
2001.
KBACW
(
h
1)
for
diuron:
0.0003
No
aerobic
aquatic
data
is
available,
diruon
t
½
was
multiplied
by
3,
MRID#
41719303.
Input
parameters
guidance.
KBACS
(
h
1)
for
diuron:
0.002
No
anaerobic
aquatic
data
is
available,
the
anaerobic
soil
met.
t
½
was
multiplied
by
0.5.
MRID#
41418806.
Input
parameters
guidance.
KDP
(
h
1)
for
diuron:
0.0007
MRID#
41418805;
Input
parameters
guidance.
KBH,
KNH,
KAH
(
h
1)
for
diuron:
0
(
stable)
MRID#
41418804.
9
KPS
(
mL/
g)
for
diuron:
14
MRID#
44490501;
Input
parameters
guidance.
MWT
(
g/
mole)
205.1
The
MERCK
INDEX9
Solubility
@
25
0C
(
ppm)
for
diuron:
420
Product
Chemistry
chapter
for
HED
RED,
2001;
Input
parameters
guidance.
Vapor
pressure
(
torr)
for
diuron:
2.0X10
7
Product
Chemistry
chapter
for
HED
RED,
2001.
Table
5:
IR
PC
PRZM/
EXAMS
input
parameters
for
3,4
DCA.
Input
variable
Input
value
&
calculations
Source/
Quality
of
data
Crop
name
citrus
label
(
EPA
Reg.
No.
1812
362).
application
rate
(
lb
ai/
acre)
0.0021
label
(
EPA
Reg.
No.
1812
362).
An
equivalent
value
based
on
maximum
conversion
of
diuron
to
degradates
and
the
molecular
weight
ratio
adjustment.
Application
efficiency
0.99
IR
PC
Guidance7
Spray
drift
fraction
0.064
IR
PC
Guidance
Application
method
ground
label
(
EPA
Reg.
No.
1812
362).
DWRATE
(
day
1)
0.008
MRID#
41719303;
Input
parameters
guidance8
DSRATE
(
day
1)
0.008
MRID#
41538701;
Input
parameters
guidance
Kd
(
mL/
g)
for
diuron:
14
MRID#
44490501;
Input
parameters
guidance
Henry
(
atm.
m3/
mole)
for
diuron:
2.2X10
10
(
calculated)
Product
Chemistry
chapter
for
HED
RED,
2001.
KBACW
(
h
1)
for
diuron:
0.0003
No
aerobic
a
q
u
a
t
i
c
d
a
t
a
i
s
available,
diruon
t
½
was
multiplied
by
3,
MRID#
41719303.
Input
parameters
guidance.
KBACS
(
h
1)
for
diuron:
0.002
No
anaerobic
aquatic
data
is
available,
the
anaerobic
soil
met.
t
½
was
multiplied
by
0.5.
MRID#
41418806.
Input
parameters
guidance.
10
KDP
(
h
1)
for
diuron:
0.0007
MRID#
41418805;
Input
parameters
guidance.
KBH,
KNH,
KAH
(
h
1)
for
diuron:
0
(
stable)
MRID#
41418804.
KPS
(
mL/
g)
for
diuron:
14
MRID#
44490501;
Input
parameters
guidance.
MWT
(
g/
mole)
162.1
The
MERCK
INDEX9
Solubility
@
25
0C
(
ppm)
for
diuron:
420
Product
Chemistry
chapter
for
HED
RED,
2001;
Input
parameters
guidance.
Vapor
pressure
(
torr)
for
diuron:
2.0X10
7
Product
Chemistry
chapter
for
HED
RED,
2001.
Table
6:
IR
PC
PRZM/
EXAMS
input
parameters
for
mPDMU.
Input
variable
Input
value
&
calculations
Source/
Quality
of
data
Crop
name
citrus
label
(
EPA
Reg.
No.
1812
362).
application
rate
(
lb
ai/
acre)
2.04
label
(
EPA
Reg.
No.
1812
362).
An
equivalent
value
based
on
maximum
conversion
of
diuron
to
degradates
and
the
molecular
weight
ratio
adjustment.
Application
efficiency
0.99
IR
PC
Guidance7
Spray
drift
fraction
0.064
IR
PC
Guidance
Application
method
ground
label
(
EPA
Reg.
No.
1812
362).
DWRATE
(
day
1)
for
diuron:
0.002
MRID#
41719303;
Input
parameters
guidance8
DSRATE
(
day
1)
for
diuron:
0.002
MRID#
41719303;
Input
parameters
guidance
Kd
(
mL/
g)
for
diuron:
14
MRID#
44490501;
Input
parameters
guidance
Henry
(
atm.
m3/
mole)
for
diuron:
2.2X10
10
(
calculated)
Product
Chemistry
chapter
for
HED
RED,
2001.
KBACW
(
h
1)
0.00008
MRID#
42661901.
Input
parameters
guidance.
11
KBACS
(
h
1)
0.00005
MRID#
42260501.
Input
parameters
guidance.
KDP
(
h
1)
for
diuron:
0.0007
MRID#
41418805;
Input
parameters
guidance.
KBH,
KNH,
KAH
(
h
1)
for
diuron:
0
(
stable)
MRID#
41418804.
KPS
(
mL/
g)
for
diuron:
14
MRID#
44490501;
Input
parameters
guidance.
MWT
(
g/
mole)
233.1
The
MERCK
INDEX9
Solubility
@
25
0C
(
ppm)
for
diuron:
420
Product
Chemistry
chapter
for
HED
RED,
2001;
Input
parameters
guidance.
Vapor
pressure
(
torr)
for
diuron:
2.0X10
7
Product
Chemistry
chapter
for
HED
RED,
2001.
Assumptions
and
Uncertainties7,10
Index
Reservoir
The
index
reservoir
represents
potential
drinking
water
exposure
from
a
specific
area
(
Illinois)
with
specific
cropping
patterns,
weather,
soils,
and
other
factors.
Use
of
the
index
reservoir
for
areas
with
different
climates,
crops,
pesticides
used,
sources
of
water
(
e.
g.
rivers
instead
of
reservoirs,
etc),
and
hydrogeology
creates
uncertainties.
In
general,
because
the
index
reservoir
represents
a
fairly
vulnerable
watershed,
the
exposure
estimated
with
the
index
reservoir
will
likely
be
higher
than
the
actual
exposure
for
most
drinking
water
sources.
However,
the
index
reservoir
is
not
a
worst
case
scenario,
communities
that
derive
their
drinking
water
from
smaller
bodies
of
water
with
minimal
outflow,
or
with
more
runoff
prone
soils
would
likely
get
higher
drinking
water
exposure
than
estimated
using
the
index
reservoir.
Areas
with
a
more
humid
climate
that
use
a
similar
reservoir
and
cropping
patterns
may
also
get
more
pesticides
in
their
drinking
water
than
predicted
using
this
scenario.
A
single
steady
flow
has
been
used
to
represent
the
flow
through
the
reservoir.
Discharge
from
the
reservoir
also
removes
chemical
so
this
assumption
will
underestimate
removal
from
the
12
reservoir
during
wet
periods
and
overestimates
removal
during
dry
periods.
This
assumption
can
both
underestimate
or
overestimate
the
concentration
in
the
pond
depending
upon
the
annual
precipitation
pattern
at
the
site.
The
index
reservoir
scenario
uses
the
characteristics
of
a
single
soil
to
represent
the
soil
in
the
basin.
In
fact,
soils
can
vary
substantially
across
even
small
areas,
and
this
variation
is
not
reflected
in
these
simulations.
The
index
reservoir
scenario
does
not
consider
tile
drainage.
Areas
that
are
prone
to
substantial
runoff
are
often
tile
drained.
Tile
drainage
contributes
additional
water
and
in
some
cases,
additional
pesticide
loading
to
the
reservoir.
This
may
cause
either
an
increase
or
decrease
in
the
pesticide
concentration
in
the
reservoir.
Tile
drainage
also
causes
the
surface
soil
to
dry
out
faster.
This
will
reduce
runoff
of
the
pesticide
into
the
reservoir.
The
watershed
used
as
the
model
for
the
index
reservoir
(
Shipman
City
Lake)
does
not
have
tile
drainage
in
the
cropped
areas.
EXAMS
is
unable
to
easily
model
spring
and
fall
turnover.
Turnover
occurs
when
the
temperature
drops
in
the
fall
and
the
thermal
stratification
of
the
reservoir
is
removed.
Turnover
occurs
again
in
the
spring
when
the
reservoir
warms
up.
This
results
in
complete
mixing
of
the
chemical
through
the
water
column
at
these
times.
Because
of
this
inability,
the
Index
Reservoir
has
been
simulated
without
stratification.
There
is
data
to
suggest
that
Shipman
City
Lake,
upon
which
the
Index
Reservoir
is
based,
does
indeed
stratify
in
the
deepest
parts
of
the
lake
at
least
in
some
years.
This
may
result
in
both
over
and
underestimation
of
the
concentration
in
drinking
water
depending
upon
the
time
of
the
year
and
the
depth
the
drinking
water
intake
is
drawing
from.
Percent
Crop
Area
Correction
Factor
The
PCA
is
a
watershed
based
modification.
Implicit
in
its
application
is
the
assumption
that
currently
used
field
scale
models
reflect
basin
scale
processes
consistently
for
all
pesticides
and
uses.
In
other
words,
we
assume
that
the
large
field
simulated
by
the
coupled
PRZM
and
EXAMS
models
is
a
reasonable
approximation
of
pesticide
fate
and
transport
within
a
watershed
that
contains
a
drinking
water
reservoir.
If
the
13
models
fail
to
capture
pertinent
basin
scale
fate
and
transport
processes
consistently
for
all
pesticides
and
all
uses,
the
application
of
a
factor
that
reduces
the
estimated
concentrations
predicted
by
modeling
could,
in
some
instances,
result
in
inadvertently
passing
a
chemical
through
the
screen
that
may
actually
pose
a
risk.
Some
preliminary
assessments
made
in
the
development
of
the
PCA
suggest
that
PRZM/
EXAMS
may
not
be
realistically
capturing
basin
scale
processes
for
all
pesticides
or
for
all
uses.
A
preliminary
survey
of
water
assessments
which
compared
screening
model
estimates
to
readily
available
monitoring
data
suggest
uneven
model
results.
In
some
instances,
the
screening
model
estimates
are
more
than
an
order
of
magnitude
greater
than
the
highest
concentrations
reported
in
available
monitoring
data;
in
other
instances,
the
model
estimates
are
less
than
monitoring
concentrations.
Because
of
these
concerns,
the
SAP
recommended
using
the
PCA
only
for
"
major"
crops
in
the
Midwest.
For
other
crops,
development
of
PCA's
will
depend
on
the
availability
of
relevant
monitoring
data
that
could
be
used
to
evaluate
the
result
of
the
PCA
adjustment.
The
spatial
data
used
for
the
PCA
came
from
readily
available
sources
and
have
a
number
of
inherent
limitations:
°
The
size
of
the
8
digit
HUC
[
mean
=
366,989
ha;
range
=
6.7
2,282,081
ha;
n
=
2,111]
may
not
provide
reasonable
estimates
of
actual
PCA's
for
smaller
watersheds.
The
watersheds
that
drain
into
drinking
water
reservoirs
are
generally
smaller
than
the
8
digit
HUC
and
may
be
better
represented
by
watersheds
defined
for
drinking
water
intakes.
°
The
conversion
of
the
county
level
data
to
watershed
based
percent
crop
areas
assumes
the
distribution
of
the
crops
within
a
county
is
uniform
and
homogeneous
throughout
the
county
area.
Distance
between
the
treated
fields
and
the
water
body
is
not
addressed.
°
The
PCA's
were
generated
using
data
from
the
1992
Census
of
Agriculture.
However,
recent
changes
in
the
agriculture
sector
from
farm
bill
legislation
may
significantly
impact
the
distribution
of
crops
throughout
the
country.
The
methods
described
in
this
report
can
rapidly
be
updated
as
more
current
agricultural
crops
data
are
obtained.
The
assumption
that
yearly
changes
in
cropping
patterns
will
cause
minimal
impact
needs
to
be
evaluated.
14
The
PCA
adjustment
is
only
applicable
to
pesticides
applied
to
agricultural
crops.
Contributions
to
surface
waters
from
nonagricultural
uses
such
as
urban
environments
are
not
wellmodeled
Currently,
non
agricultural
uses
are
not
included
in
the
screening
model
assessments
for
drinking
water.
The
PCA
does
not
consider
percent
crop
treated
because
detailed
pesticide
usage
data
are
extremely
limited
at
this
time.
Detailed
pesticide
usage
data
are
currently
available
for
only
a
few
states.
Groundwater
Monitoring
EFED
has
limited
targeted
monitoring
data
on
the
concentrations
of
diuron
and
its
degradates
in
groundwater.
Table
7
shows
validated
monitoring
data
for
diuron
that
are
available
for
the
states
of
California
(
CA),
Florida
(
FL),
Georgia
(
GA),
and
Texas
(
TX).
Table
7.
Groundwater
monitoring
data
for
diuron.
Number
of
wells
sampled
(
number
of
wells
with
residues)
11.
State
number
of
well
range
of
conc.
(
ppb)
15
CA
2010
(
82)
0.05
3.95
FL
15385
(
9)
1.18
5.37
GA
70
(
67)
1.00
5.00
TX
31
(
2)
0.01
0.02
According
to
the
Ground
Water
Protection
Section
of
the
Florida
Department
of
Environmental
Protection12,
ground
water
samples
from
wells
collected
between
May/
1990
and
November/
1997,
showed
diuron
detections
ranging
from
0.94
12
ppb
(
detection
limit
=
0.48
ppb).
The
arithmetic
mean
concentration
was
2.44
ppb.
Well
water
samples
were
collected
from
the
following
counties:
Highlands,
Jackson,
Lake,
Orange,
and
Polk.
With
the
exception
of
the
12
ppb
sample
in
Orange
County,
the
majority
of
the
detections
were
in
Highlands
County
where
citrus
is
grown.
Diuron
concentrations
in
Highlands
County
decreased
with
time
to
about
1
ppb
but
were
detected
every
year.
In
Polk
County,
diuron
concentrations
show
a
seasonal
pattern,
with
highest
concentrations
in
the
spring
and
lowest
concentrations
in
the
fall,
but
was
not
detected
in
all
years.
The
US
Geological
Survey
(
USGS)
National
Water
Quality
Assessment
Program
(
NAWQA)
13
analyzed
pesticide
occurrence
and
concentrations
for
major
aquifers
and
shallow
ground
water
in
agricultural
areas
(
detection
limit
=
0.05
ppb).
Analysis
of
2608
samples
(
major
aquifers
study)
showed
diuron
in
71%
of
the
samples
analyzed
with
a
maximum
concentration
of
0.34
ppb.
Maximum
diuron
concentration
in
897
samples
from
shallow
groundwater
sites
was
2.0
ppb,
with
diuron
detected
in
only
1.23%
of
samples
analyzed
(
USGS,
1998).
A
major
component
of
the
sampling
design
in
the
NAWQA
study
was
to
target
specific
watersheds
and
shallow
ground
water
areas
that
are
influenced
primarily
by
a
single
dominant
land
use(
agricultural
or
urban)
that
is
important
in
the
particular
area.
The
ground
water
data
were
primarily
collected
from
a
combination
of
production
and
monitoring
wells.
Ground
water
sampling
sites
were
sampled
for
pesticides
from
a
single
snap
shot
in
time.
Even
though,
the
groundwater
monitoring
data
collected
by
NAWQA
are
from
sites
considered
typical
for
use
areas,
the
frequency
of
sampling
and
the
length
of
sampling
period
were
not
sufficient
to
represent
the
temporal
and
spatial
requirements
for
regulatory
purposes.
16
Major
component
of
the
sampling
design
in
the
NAWQA
study
was
to
target
specific
watersheds
and
shallow
ground
water
areas
that
are
influenced
primarily
by
a
single
dominant
land
use(
agricultural
or
urban)
that
is
important
in
the
particular
area.
The
ground
water
data
were
primarily
collected
from
a
combination
of
production
and
monitoring
wells.
Ground
water
sites
in
the
ground
water
data
were
sampled
for
pesticides
from
a
single
snap
shot
in
time.
Modeling
The
SCI
GROW
model
was
used
to
estimate
potential
groundwater
concentrations
for
diuron
and
its
degradates.
Tables
8,
and
9
show
input
parameters
and
output
for
SCI
GROW
modeling
of
diuron
and
its
degradates,
respectively.
Table
8.
Input
parameters
for
diuron
and
its
degradates
used
in
the
SCI
GROW
model.
compound
appl.
rate
(
lb
ai/
acre)
No.
of
appl.
/
year
Aerobic
soil
t1/
2
(
d)
Koc
(
mL/
g)
Source/
Quality
of
data
Diuron
9.6
1
372
468
label
(
EPA
Reg.
No.
1812
362);
MRID#
44490501;
MRID#
41719303;
Input
parameters
guideline
(
Aug.
2000).
Good
data.
DCPMU
2.03*
1
770
468
label
(
EPA
Reg.
No.
1812
362);
MRID#
44490501;
MRID#
;
Input
parameters
guideline
(
Aug.
2000).
Good
data.
DCPU
0.08*
1
770
468
label
(
EPA
Reg.
No.
1812
362);
MRID#
44490501;
MRID#
41719303;
Input
parameters
guideline
(
Aug.
2000).
Good
data.
3,4
DCA
0.0021*
1
30
468
label
(
EPA
Reg.
No.
1812
362);
MRID#
44490501;
MRID#
41719303;
MRID#
41538701;
Input
parameters
guideline
(
Aug.
2000).
Good
data.
17
mCPDMU
1.12*
1
115
468
label
(
EPA
Reg.
No.
1812
362);
MRID#
44490501;
MRID#
41719303;
MRID#
42260501;
Input
parameters
guideline
(
Aug.
2000).
Good
data.
*:
An
equivalent
value
based
on
conversion
of
diuron
to
degradates.
Table
9.
SCI
GROW
estimated
environmental
concentrations
for
diuron
and
its
degradates
in
groundwater.
Toxicity
end
point
model
EECs
(
F
g/
L)
use(
s)
modeled
Diuron
DCPMU
DCPU
3,4
DCA
mCPDMU
one
application
of
diuron
on
citrus
@
9.6
lb
ai/
acre
acute
6.52
2.50
0.09
0.0002
0.30
Chronic
(
non
cancer)
6.52
2.50
0.09
0.0002
0.30
Chronic
(
cancer)
6.52
2.50
0.09
0.0002
0.30
The
SCI
GROW
screening
model
developed
by
EFED
indicates
that
diuron
and
its
degradates
concentrations
are
much
less
than
those
estimated
for
surface
water.
SCI
GROW
estimated
concentrations
of
diuron
do
fall
within
the
values
from
monitoring
data
shown
in
Table
8,
but
below
some
of
the
reported
monitoring
data.
This
means
that
SCI
GROW
could
underestimate
chemical
concentrations
in
typical
use
areas
when
the
pesticide
is
used
at
the
maximum
allowed
label
rate
in
areas
with
ground
water
exceptionally
vulnerable
to
contamination
such
as
Florida.
Limitations
of
the
SCI
GROW2
Analysis
The
SCI
GROW
model
(
Screening
Concentrations
in
Ground
Water)
is
a
model
for
estimating
concentrations
of
pesticides
in
ground
water
under
"
maximum
loading"
conditions.
SCI
GROW
provides
a
screening
concentration,
an
estimate
of
likely
ground
water
concentrations
if
the
pesticide
is
used
at
the
maximum
allowed
label
rate
in
areas
with
ground
water
that
is
vulnerable
to
contamination.
In
most
cases,
a
majority
of
the
use
area
will
have
ground
water
that
is
less
vulnerable
to
contamination
than
the
areas
used
to
derive
the
SCI
GROW
estimate.
18
References:
4.
Carsel,
R.
F.,
J.
C.
Imhoff,
P.
R.
Hummel,
J.
M.
Cheplick
and
J.
S.
Donigian,
Jr.
1997.
PRZM
3,
A
Model
for
Predicting
Pesticide
and
Nitrogen
Fate
in
Crop
Root
and
Unsaturated
Soil
Zones:
Users
Manual
for
Release
3.0;
Environmental
Research
Laboratory,
Office
of
Research
and
Development,
U.
S.
Environmental
Protection
Agency,
Athens,
GA.
2.
Burns,
L.
A.
March
1997.
Exposure
Analysis
Modeling
System
(
EXAMSII)
Users
Guide
for
Version
2.97.5,
Environmental
Research
Laboratory,
Office
of
Research
and
Development,
U.
S.
Environmental
Protection
Agency,
Athens,
GA.
3.
Barrett,
M.,
1997,
Proposal
For
a
Method
to
Determine
Screening
Concentration
Estimates
for
Drinking
Water
Derived
from
Groundwater
Studies,
EFED/
OPP.
4.
USGS.
1992.
National
Water
Quality
Assessment
(
NWQA),
Pesticides
National
Synthesis
Project,
Annual
Use:
Diuron.
5.
Thurman,
E.
M.,
K.
C.
Bastian,
and
T.
Mollhagen.
Occurrence
of
cotton
herbicides
and
insecticides
in
Playa
lakes
of
the
high
plains
of
western
Texas.
[
Online].
Available
at
http://
toxics.
usgs.
gov/
pubs/
wri99
4018/
Volume2/
sectionC/
2
403Thurman/
pdf/
2403_
Thurman.
pdf,
May,
2001).
6.
U.
S
GS.
1998.
National
Water
Quality
Assessment
(
NWQA),
Pesticides
National
Synthesis
Project
[
Online]
at
(
http://
ca.
water.
usgs.
gov/
pnsp/
streamsum/
streamT1.
html).
7.
Effland,
W.,
N.
Thurman,
I.
Kennedy,
R.
D.
Jones,
J.
Breithaupt,
J.
Lin,
J.
Carleton,
L.
Libel.
R.
Parker,
and
R.
Matzner.
2000.
"
Guidance
for
use
of
the
index
Reservoir
and
Percent
Crop
Area
Factor
in
drinking
water
exposure
assessment
s.
Office
of
Pesticide
Programs.
8.
Guidance
for
Chemistry
and
Management
Practice
Input
Parameters
For
Use
in
Modeling
the
Environmental
Fate
and
Transport
of
Pesticides.
Version
2.
November
7,
2000.
U.
S.
EPA
Office
of
Pesticide
Programs,
Environmental
Fate
and
Effects
Division.
9.
The
Merck
Index.
1989.
An
encyclopedia
of
chemicals,
drugs,
and
biologicals.
11th
ed.
Rahway,
N.
J.
p.
533.
19
10.
Jones,
R.
D.,
S.
W.
Abel,
W.
Effland,
R.
Matzner,
and
R.
Parker.
1998.
"
An
Index
Reservoir
for
Use
in
Assessing
Drinking
Water
Exposures.
Chapter
IV
in
Proposed
Methods
for
Basin
Scale
Estimation
of
Pesticide
Concentrations
in
Flowing
Water
and
Reservoirs
for
Tolerance
Reassessment.,
presented
to
the
FIFRA
Science
Advisory
Panel,
July
1998.
http://
www.
epa.
gov/
pesticides/
SAP/
1998/
index.
htm.
11.
U.
S.
EPA.
1992.
Pesticides
in
Ground
Water
Database
A
compilation
of
Monitoring
Studies:
1971
1991.
Office
of
Prevention,
Pesticides,
and
Toxic
Substances,
EPA
734
12
92
001.
12.
Florida
Department
of
Environmental
Protection.
2001.
Personal
communication
with
Bryan
Baker
@
the
Groundwater
Protection
Section
(
850/
921
9435).
13.
USGS.
1998.
National
Water
Quality
Assessment
(
NWQA),
Pesticides
National
Synthesis
Project,
[
Online]
at
http://
ca.
water.
usgs.
gov/
pnsp/
allsum/#
over.
APPENDIX
I
IR
PCA
PRZM/
EXAMS
INPUT
AND
OUT
PUT
FILES
FOR
MODELING
DIURON
AND
ITS
DEGRADATES
DIURON
PRZM3.12
Input
File,
flcit.
inp
(
Jan
28
2000)
Location:
Osceola
County,
FL.;
Crop:
citrus;
MLRA
156A
20
0.77
0.15
0
25.00
1
1
4
0.10
0.13
1.00
10
4
1.00
345.0
1
1
0.10
100.00
80.00
3
94
84
89
0.00
100.00
1
3
0101
21
9
2209
0.10
0.10
0.10
.023
.023
.023
36
020148
030148
311248
1
020149
030149
311249
1
020150
030150
311250
1
020151
030151
311251
1
020152
030152
311252
1
020153
030153
311253
1
020154
030154
311254
1
020155
030155
311255
1
020156
030156
311256
1
020157
030157
311257
1
020158
030158
311258
1
020159
030159
311259
1
020160
030160
311260
1
020161
030161
311261
1
020162
030162
311262
1
020163
030163
311263
1
020164
030164
311264
1
020165
030165
311265
1
020166
030166
311266
1
020167
030167
311267
1
020168
030168
311268
1
020169
030169
311269
1
020170
030170
311270
1
020171
030171
311271
1
020172
030172
311272
1
020173
030173
311273
1
020174
030174
311274
1
020175
030175
311275
1
020176
030176
311276
1
020177
030177
311277
1
020178
030178
311278
1
020179
030179
311279
1
020180
030180
311280
1
020181
030181
311281
1
020182
030182
311282
1
020183
030183
311283
1
Application:
3,4
DCA:
One
ground
appl.
@
9.6
lb
a.
i./
ac
(
10.7
Kg/
h)
@
99%
eff,
w/
6.4%
drift
36
1
0
0
Diuron
070148
0
2
0.00
10.76
0.99
0.064
21
070149
0
2
0.00
10.76
0.99
0.064
070150
0
2
0.00
10.76
0.99
0.064
070151
0
2
0.00
10.76
0.99
0.064
070152
0
2
0.00
10.76
0.99
0.064
070153
0
2
0.00
10.76
0.99
0.064
070154
0
2
0.00
10.76
0.99
0.064
070155
0
2
0.00
10.76
0.99
0.064
070156
0
2
0.00
10.76
0.99
0.064
070157
0
2
0.00
10.76
0.99
0.064
070158
0
2
0.00
10.76
0.99
0.064
070159
0
2
0.00
10.76
0.99
0.064
070160
0
2
0.00
10.76
0.99
0.064
070161
0
2
0.00
10.76
0.99
0.064
070162
0
2
0.00
10.76
0.99
0.064
070163
0
2
0.00
10.76
0.99
0.064
070164
0
2
0.00
10.76
0.99
0.064
070165
0
2
0.00
10.76
0.99
0.064
070166
0
2
0.00
10.76
0.99
0.064
070167
0
2
0.00
10.76
0.99
0.064
070168
0
2
0.00
10.76
0.99
0.064
070169
0
2
0.00
10.76
0.99
0.064
070170
0
2
0.00
10.76
0.99
0.064
070171
0
2
0.00
10.76
0.99
0.064
070172
0
2
0.00
10.76
0.99
0.064
070173
0
2
0.00
10.76
0.99
0.064
070174
0
2
0.00
10.76
0.99
0.064
070175
0
2
0.00
10.76
0.99
0.064
070176
0
2
0.00
10.76
0.99
0.064
070177
0
2
0.00
10.76
0.99
0.064
070178
0
2
0.00
10.76
0.99
0.064
070179
0
2
0.00
10.76
0.99
0.064
070180
0
2
0.00
10.76
0.99
0.064
070181
0
2
0.00
10.76
0.99
0.064
070182
0
2
0.00
10.76
0.99
0.064
070183
0
2
0.00
10.76
0.99
0.064
0.00
1
0.00
0.00
0.000
0.50
Soil
Series:
Adamsville
sand;
Hydrogic
Group
C
100.00
0
0
0
0
0
0
0
0
0
0.0
0.00
00.00
3
1
10.000
1.440
0.086
0.000
0.000
0.000
.002
.002
0.000
0.100
0.086
0.036
0.580
14.00
2
10.000
1.440
0.086
0.000
0.000
0.000
.002
.002
0.000
1.000
0.086
0.036
0.580
14.00
3
80.000
1.580
0.030
0.000
0.000
0.000
.002
.002
0.000
5.000
0.030
0.023
0.116
14.00
22
0
WATR
YEAR
10
PEST
YEAR
10
CONC
YEAR
10
1
6
11
1
DAY
RUNF
TSER
0
0
1.
E0
OUTPUT
FILE
WATER
COLUMN
DISSOLVED
CONCENTRATION
(
PPB)
YEAR
PEAK
96
HOUR
21
DAY
60
DAY
90
DAY
YEARLY
1948
351.000
340.000
300.000
274.000
249.000
137.000
1949
1920.000
1860.000
1680.000
1450.000
1250.000
448.000
1950
306.000
296.000
264.000
229.000
213.000
112.000
1951
477.000
462.000
406.000
310.000
281.000
135.000
1952
413.000
399.000
350.000
273.000
231.000
95.430
1953
490.000
476.000
438.000
399.000
346.000
143.000
1954
512.000
496.000
446.000
375.000
329.000
158.000
1955
551.000
539.000
498.000
405.000
342.000
137.000
1956
351.000
340.000
307.000
274.000
247.000
110.000
1957
728.000
706.000
621.000
473.000
397.000
181.000
1958
680.000
658.000
576.000
450.000
383.000
175.000
1959
319.000
313.000
280.000
223.000
215.000
119.000
1960
1010.000
975.000
875.000
679.000
566.000
203.000
1961
562.000
545.000
481.000
372.000
321.000
182.000
1962
416.000
403.000
355.000
288.000
248.000
105.000
1963
417.000
404.000
354.000
310.000
267.000
115.000
1964
504.000
495.000
450.000
350.000
312.000
125.000
1965
351.000
340.000
300.000
251.000
219.000
111.000
1966
980.000
951.000
846.000
679.000
575.000
255.000
1967
527.000
510.000
467.000
370.000
308.000
133.000
1968
538.000
526.000
502.000
421.000
358.000
147.000
1969
438.000
425.000
374.000
332.000
291.000
129.000
1970
584.000
573.000
512.000
399.000
332.000
147.000
1971
592.000
577.000
524.000
449.000
382.000
155.000
1972
428.000
418.000
388.000
316.000
265.000
119.000
1973
381.000
370.000
327.000
259.000
219.000
97.670
1974
402.000
389.000
344.000
260.000
227.000
121.000
1975
177.000
171.000
152.000
128.000
109.000
48.160
1976
339.000
329.000
301.000
257.000
236.000
116.000
1977
1560.000
1510.000
1360.000
1190.000
1020.000
369.000
1978
210.000
204.000
187.000
162.000
154.000
78.430
23
1979
2330.000
2260.000
2010.000
1580.000
1330.000
454.000
1980
997.000
969.000
885.000
699.000
613.000
255.000
1981
609.000
591.000
521.000
398.000
349.000
154.000
1982
1110.000
1090.000
994.000
810.000
689.000
255.000
1983
749.000
726.000
686.000
633.000
563.000
218.000
SORTED
FOR
PLOTTING
PROB
PEAK
96
HOUR
21
DAY
60
DAY
90
DAY
YEARLY
0.027
2330.000
2260.000
2010.000
1580.000
1330.000
454.000
0.054
1920.000
1860.000
1680.000
1450.000
1250.000
448.000
0.081
1560.000
1510.000
1360.000
1190.000
1020.000
369.000
0.108
1110.000
1090.000
994.000
810.000
689.000
255.000
0.135
1010.000
975.000
885.000
699.000
613.000
255.000
0.162
997.000
969.000
875.000
679.000
575.000
255.000
0.189
980.000
951.000
846.000
679.000
566.000
218.000
0.216
749.000
726.000
686.000
633.000
563.000
203.000
0.243
728.000
706.000
621.000
473.000
397.000
182.000
0.270
680.000
658.000
576.000
450.000
383.000
181.000
0.297
609.000
591.000
524.000
449.000
382.000
175.000
0.324
592.000
577.000
521.000
421.000
358.000
158.000
0.351
584.000
573.000
512.000
405.000
349.000
155.000
0.378
562.000
545.000
502.000
399.000
346.000
154.000
0.405
551.000
539.000
498.000
399.000
342.000
147.000
0.432
538.000
526.000
481.000
398.000
332.000
147.000
0.459
527.000
510.000
467.000
375.000
329.000
143.000
0.486
512.000
496.000
450.000
372.000
321.000
137.000
0.514
504.000
495.000
446.000
370.000
312.000
137.000
0.541
490.000
476.000
438.000
350.000
308.000
135.000
0.568
477.000
462.000
406.000
332.000
291.000
133.000
0.595
438.000
425.000
388.000
316.000
281.000
129.000
0.622
428.000
418.000
374.000
310.000
267.000
125.000
0.649
417.000
404.000
355.000
310.000
265.000
121.000
0.676
416.000
403.000
354.000
288.000
249.000
119.000
0.703
413.000
399.000
350.000
274.000
248.000
119.000
0.730
402.000
389.000
344.000
274.000
247.000
116.000
0.757
381.000
370.000
327.000
273.000
236.000
115.000
0.784
351.000
340.000
307.000
260.000
231.000
112.000
0.811
351.000
340.000
301.000
259.000
227.000
111.000
0.838
351.000
340.000
300.000
257.000
219.000
110.000
0.865
339.000
329.000
300.000
251.000
219.000
105.000
0.892
319.000
313.000
280.000
229.000
215.000
97.670
0.919
306.000
296.000
264.000
223.000
213.000
95.430
0.946
210.000
204.000
187.000
162.000
154.000
78.430
0.973
177.000
171.000
152.000
128.000
109.000
48.160
1/
10
1245.000
1216.000
1103.800
924.000
788.300
289.200
24
MEAN
OF
ANNUAL
VALUES
=
167.852
STANDARD
DEVIATION
OF
ANNUAL
VALUES
=
91.941
UPPER
90%
CONFIDENCE
LIMIT
ON
MEAN
=
190.542
DCPMU
PRZM3.12
Input
File,
flcit.
inp
(
Jan
28
2000)
Location:
Osceola
County,
FL.;
Crop:
citrus;
MLRA
156A
0.77
0.15
0
25.00
1
1
4
0.10
0.13
1.00
172.8
4
1.00
600.0
1
1
0.10
100.00
80.00
3
94
84
89
0.00
100.00
1
3
0101
21
9
2209
0.10
0.10
0.10
.023
.023
.023
36
020148
030148
311248
1
020149
030149
311249
1
020150
030150
311250
1
020151
030151
311251
1
020152
030152
311252
1
020153
030153
311253
1
020154
030154
311254
1
020155
030155
311255
1
020156
030156
311256
1
020157
030157
311257
1
020158
030158
311258
1
020159
030159
311259
1
020160
030160
311260
1
020161
030161
311261
1
020162
030162
311262
1
020163
030163
311263
1
020164
030164
311264
1
020165
030165
311265
1
020166
030166
311266
1
020167
030167
311267
1
020168
030168
311268
1
020169
030169
311269
1
020170
030170
311270
1
020171
030171
311271
1
020172
030172
311272
1
020173
030173
311273
1
020174
030174
311274
1
25
020175
030175
311275
1
020176
030176
311276
1
020177
030177
311277
1
020178
030178
311278
1
020179
030179
311279
1
020180
030180
311280
1
020181
030181
311281
1
020182
030182
311282
1
020183
030183
311283
1
Application:
DCPMU:
One
ground
appl.
@
2.03
lb
a.
i./
ac
(
2.27
Kg/
h)
@
99%
eff,
w/
6.4%
drift
36
1
0
0
DCPMU
010748
0
2
0.00
2.27
0.99
0.064
010749
0
2
0.00
2.27
0.99
0.064
010750
0
2
0.00
2.27
0.99
0.064
010751
0
2
0.00
2.27
0.99
0.064
010752
0
2
0.00
2.27
0.99
0.064
010753
0
2
0.00
2.27
0.99
0.064
010754
0
2
0.00
2.27
0.99
0.064
010755
0
2
0.00
2.27
0.99
0.064
010756
0
2
0.00
2.27
0.99
0.064
010757
0
2
0.00
2.27
0.99
0.064
010758
0
2
0.00
2.27
0.99
0.064
010759
0
2
0.00
2.27
0.99
0.064
010760
0
2
0.00
2.27
0.99
0.064
010761
0
2
0.00
2.27
0.99
0.064
010762
0
2
0.00
2.27
0.99
0.064
010763
0
2
0.00
2.27
0.99
0.064
010764
0
2
0.00
2.27
0.99
0.064
010765
0
2
0.00
2.27
0.99
0.064
010766
0
2
0.00
2.27
0.99
0.064
010767
0
2
0.00
2.27
0.99
0.064
010768
0
2
0.00
2.27
0.99
0.064
010769
0
2
0.00
2.27
0.99
0.064
010770
0
2
0.00
2.27
0.99
0.064
010771
0
2
0.00
2.27
0.99
0.064
010772
0
2
0.00
2.27
0.99
0.064
010773
0
2
0.00
2.27
0.99
0.064
010774
0
2
0.00
2.27
0.99
0.064
010775
0
2
0.00
2.27
0.99
0.064
010776
0
2
0.00
2.27
0.99
0.064
010777
0
2
0.00
2.27
0.99
0.064
010778
0
2
0.00
2.27
0.99
0.064
010779
0
2
0.00
2.27
0.99
0.064
010780
0
2
0.00
2.27
0.99
0.064
010781
0
2
0.00
2.27
0.99
0.064
010782
0
2
0.00
2.27
0.99
0.064
010783
0
2
0.00
2.27
0.99
0.064
0.00
1
0.00
0.00
0.000
0.50
26
Soil
Series:
Adamsville
sand;
Hydrogic
Group
C
100.00
0
0
0
0
0
0
0
0
0
0.0
0.00
00.00
3
1
10.000
1.440
0.086
0.000
0.000
0.000
.009
.009
0.000
0.100
0.086
0.036
0.580
14.00
2
10.000
1.440
0.086
0.000
0.000
0.000
.009
.009
0.000
1.000
0.086
0.036
0.580
14.00
3
80.000
1.580
0.030
0.000
0.000
0.000
.009
.009
0.000
5.000
0.030
0.023
0.116
14.00
0
WATR
YEAR
10
PEST
YEAR
10
CONC
YEAR
10
1
6
11
1
DAY
RUNF
TSER
0
0
1.
E0
OUTPUT
FILE
WATER
COLUMN
DISSOLVED
CONCENTRATION
(
PPB)
YEAR
PEAK
96
HOUR
21
DAY
60
DAY
90
DAY
YEARLY
1948
24.990
23.880
21.930
19.630
19.030
7.345
1949
13.850
13.300
11.630
10.240
8.940
3.738
1950
27.340
26.130
23.770
19.860
17.560
6.493
1951
61.630
59.040
50.300
36.310
29.200
9.915
1952
98.750
94.410
78.890
56.350
45.540
15.380
1953
34.930
33.420
28.450
25.060
21.920
8.402
1954
49.500
47.300
43.730
31.770
26.870
9.186
1955
24.200
23.130
19.600
15.180
13.230
5.329
1956
23.340
22.480
19.800
15.370
13.170
4.987
1957
77.010
74.100
62.000
52.420
44.450
14.820
1958
27.160
26.390
23.010
17.690
15.500
5.692
1959
30.280
29.570
27.500
25.120
22.530
7.938
1960
39.220
37.660
33.950
26.420
22.100
8.718
1961
14.690
14.050
12.030
9.927
8.508
3.954
1962
23.590
22.580
20.690
15.960
14.460
5.580
1963
24.690
23.700
21.370
16.260
13.340
5.172
1964
47.560
45.500
38.450
28.970
24.490
9.142
1965
23.240
22.310
19.310
16.740
15.780
6.802
27
1966
19.870
19.010
16.520
13.780
12.080
4.739
1967
39.600
37.840
31.640
28.120
24.630
8.865
1968
25.620
24.510
22.680
18.040
16.100
6.135
1969
34.740
33.230
30.440
27.080
23.370
7.923
1970
15.350
14.730
12.690
9.355
8.026
3.635
1971
16.650
15.910
13.520
12.360
12.330
4.912
1972
40.250
38.840
33.780
27.100
23.140
7.859
1973
18.960
18.240
16.990
14.140
13.370
5.461
1974
21.770
20.830
18.820
14.480
12.230
4.570
1975
25.430
24.310
20.190
16.120
13.640
4.879
1976
29.110
28.180
23.930
17.990
17.420
6.575
1977
21.570
20.610
17.620
15.490
14.370
5.469
1978
5.394
5.227
4.425
3.703
3.483
1.825
1979
29.560
28.280
25.580
20.670
18.000
6.558
1980
35.180
33.620
29.890
26.040
22.060
8.045
1981
49.070
47.300
40.870
32.650
27.050
9.604
1982
7.314
7.062
6.518
5.605
5.538
3.129
1983
52.760
51.190
44.070
32.050
25.940
8.631
SORTED
FOR
PLOTTING
PROB
PEAK
96
HOUR
21
DAY
60
DAY
90
DAY
YEARLY
0.027
98.750
94.410
78.890
56.350
45.540
15.380
0.054
77.010
74.100
62.000
52.420
44.450
14.820
0.081
61.630
59.040
50.300
36.310
29.200
9.915
0.108
52.760
51.190
44.070
32.650
27.050
9.604
0.135
49.500
47.300
43.730
32.050
26.870
9.186
0.162
49.070
47.300
40.870
31.770
25.940
9.142
0.189
47.560
45.500
38.450
28.970
24.630
8.865
0.216
40.250
38.840
33.950
28.120
24.490
8.718
0.243
39.600
37.840
33.780
27.100
23.370
8.631
0.270
39.220
37.660
31.640
27.080
23.140
8.402
0.297
35.180
33.620
30.440
26.420
22.530
8.045
0.324
34.930
33.420
29.890
26.040
22.100
7.938
0.351
34.740
33.230
28.450
25.120
22.060
7.923
0.378
30.280
29.570
27.500
25.060
21.920
7.859
0.405
29.560
28.280
25.580
20.670
19.030
7.345
0.432
29.110
28.180
23.930
19.860
18.000
6.802
0.459
27.340
26.390
23.770
19.630
17.560
6.575
0.486
27.160
26.130
23.010
18.040
17.420
6.558
0.514
25.620
24.510
22.680
17.990
16.100
6.493
0.541
25.430
24.310
21.930
17.690
15.780
6.135
0.568
24.990
23.880
21.370
16.740
15.500
5.692
0.595
24.690
23.700
20.690
16.260
14.460
5.580
0.622
24.200
23.130
20.190
16.120
14.370
5.469
0.649
23.590
22.580
19.800
15.960
13.640
5.461
0.676
23.340
22.480
19.600
15.490
13.370
5.329
0.703
23.240
22.310
19.310
15.370
13.340
5.172
28
0.730
21.770
20.830
18.820
15.180
13.230
4.987
0.757
21.570
20.610
17.620
14.480
13.170
4.912
0.784
19.870
19.010
16.990
14.140
12.330
4.879
0.811
18.960
18.240
16.520
13.780
12.230
4.739
0.838
16.650
15.910
13.520
12.360
12.080
4.570
0.865
15.350
14.730
12.690
10.240
8.940
3.954
0.892
14.690
14.050
12.030
9.927
8.508
3.738
0.919
13.850
13.300
11.630
9.355
8.026
3.635
0.946
7.314
7.062
6.518
5.605
5.538
3.129
0.973
5.394
5.227
4.425
3.703
3.483
1.825
1/
10
55.421
53.545
45.939
33.748
27.695
9.697
MEAN
OF
ANNUAL
VALUES
=
6.872
STANDARD
DEVIATION
OF
ANNUAL
VALUES
=
2.844
UPPER
90%
CONFIDENCE
LIMIT
ON
MEAN
=
7.574
DCPU
PRZM3.12
Input
File,
flcit.
inp
(
Jan
28
2000)
Location:
Osceola
County,
FL.;
Crop:
citrus;
MLRA
156A
0.77
0.15
0
25.00
1
1
4
0.10
0.13
1.00
172.8
4
1.00
600.0
1
1
0.10
100.00
80.00
3
94
84
89
0.00
100.00
1
3
0101
21
9
2209
0.10
0.10
0.10
.023
.023
.023
36
020148
030148
311248
1
020149
030149
311249
1
020150
030150
311250
1
020151
030151
311251
1
020152
030152
311252
1
020153
030153
311253
1
020154
030154
311254
1
020155
030155
311255
1
020156
030156
311256
1
020157
030157
311257
1
020158
030158
311258
1
020159
030159
311259
1
020160
030160
311260
1
020161
030161
311261
1
29
020162
030162
311262
1
020163
030163
311263
1
020164
030164
311264
1
020165
030165
311265
1
020166
030166
311266
1
020167
030167
311267
1
020168
030168
311268
1
020169
030169
311269
1
020170
030170
311270
1
020171
030171
311271
1
020172
030172
311272
1
020173
030173
311273
1
020174
030174
311274
1
020175
030175
311275
1
020176
030176
311276
1
020177
030177
311277
1
020178
030178
311278
1
020179
030179
311279
1
020180
030180
311280
1
020181
030181
311281
1
020182
030182
311282
1
020183
030183
311283
1
Application:
DCPU:
One
ground
appl.
@
0.08
lb
a.
i./
ac
(
0.09
Kg/
h)
@
99%
eff,
w/
6.4%
drift
36
1
0
0
DCPU
010748
0
2
0.00
0.09
0.99
0.064
010749
0
2
0.00
0.09
0.99
0.064
010750
0
2
0.00
0.09
0.99
0.064
010751
0
2
0.00
0.09
0.99
0.064
010752
0
2
0.00
0.09
0.99
0.064
010753
0
2
0.00
0.09
0.99
0.064
010754
0
2
0.00
0.09
0.99
0.064
010755
0
2
0.00
0.09
0.99
0.064
010756
0
2
0.00
0.09
0.99
0.064
010757
0
2
0.00
0.09
0.99
0.064
010758
0
2
0.00
0.09
0.99
0.064
010759
0
2
0.00
0.09
0.99
0.064
010760
0
2
0.00
0.09
0.99
0.064
010761
0
2
0.00
0.09
0.99
0.064
010762
0
2
0.00
0.09
0.99
0.064
010763
0
2
0.00
0.09
0.99
0.064
010764
0
2
0.00
0.09
0.99
0.064
010765
0
2
0.00
0.09
0.99
0.064
010766
0
2
0.00
0.09
0.99
0.064
010767
0
2
0.00
0.09
0.99
0.064
010768
0
2
0.00
0.09
0.99
0.064
010769
0
2
0.00
0.09
0.99
0.064
010770
0
2
0.00
0.09
0.99
0.064
010771
0
2
0.00
0.09
0.99
0.064
010772
0
2
0.00
0.09
0.99
0.064
30
010773
0
2
0.00
0.09
0.99
0.064
010774
0
2
0.00
0.09
0.99
0.064
010775
0
2
0.00
0.09
0.99
0.064
010776
0
2
0.00
0.09
0.99
0.064
010777
0
2
0.00
0.09
0.99
0.064
010778
0
2
0.00
0.09
0.99
0.064
010779
0
2
0.00
0.09
0.99
0.064
010780
0
2
0.00
0.09
0.99
0.064
010781
0
2
0.00
0.09
0.99
0.064
010782
0
2
0.00
0.09
0.99
0.064
010783
0
2
0.00
0.09
0.99
0.064
0.00
1
0.00
0.00
0.000
0.50
Soil
Series:
Adamsville
sand;
Hydrogic
Group
C
100.00
0
0
0
0
0
0
0
0
0
0.0
0.00
00.00
3
1
10.000
1.440
0.086
0.000
0.000
0.000
.009
.009
0.000
0.100
0.086
0.036
0.580
14.00
2
10.000
1.440
0.086
0.000
0.000
0.000
.009
.009
0.000
1.000
0.086
0.036
0.580
14.00
3
80.000
1.580
0.030
0.000
0.000
0.000
.009
.009
0.000
5.000
0.030
0.023
0.116
14.00
0
WATR
YEAR
10
PEST
YEAR
10
CONC
YEAR
10
1
6
11
1
DAY
RUNF
TSER
0
0
1.
E0
OUTPUT
FILE
WATER
COLUMN
DISSOLVED
CONCENTRATION
(
PPB)
YEAR
PEAK
96
HOUR
21
DAY
60
DAY
90
DAY
YEARLY
1948
0.991
0.947
0.869
0.778
0.754
0.291
1949
0.549
0.527
0.461
0.406
0.354
0.148
1950
1.084
1.036
0.942
0.787
0.696
0.257
1951
2.443
2.341
1.994
1.440
1.158
0.393
1952
3.915
3.743
3.128
2.234
1.805
0.610
1953
1.385
1.325
1.128
0.994
0.869
0.333
31
1954
1.963
1.875
1.734
1.260
1.065
0.364
1955
0.960
0.917
0.777
0.602
0.525
0.211
1956
0.925
0.892
0.785
0.609
0.522
0.198
1957
3.053
2.938
2.458
2.078
1.762
0.588
1958
1.077
1.047
0.913
0.702
0.615
0.226
1959
1.201
1.173
1.090
0.996
0.893
0.315
1960
1.555
1.493
1.346
1.048
0.876
0.346
1961
0.582
0.557
0.477
0.394
0.337
0.157
1962
0.935
0.895
0.820
0.633
0.573
0.221
1963
0.979
0.940
0.847
0.645
0.529
0.205
1964
1.886
1.804
1.525
1.149
0.971
0.362
1965
0.921
0.884
0.766
0.664
0.626
0.270
1966
0.788
0.753
0.655
0.546
0.479
0.188
1967
1.570
1.500
1.255
1.115
0.977
0.352
1968
1.016
0.971
0.899
0.715
0.638
0.243
1969
1.377
1.318
1.207
1.074
0.927
0.314
1970
0.609
0.584
0.503
0.371
0.318
0.144
1971
0.660
0.631
0.536
0.490
0.489
0.195
1972
1.596
1.540
1.339
1.074
0.918
0.312
1973
0.752
0.723
0.674
0.561
0.530
0.216
1974
0.863
0.826
0.746
0.574
0.485
0.181
1975
1.008
0.964
0.800
0.639
0.540
0.193
1976
1.154
1.117
0.949
0.713
0.691
0.261
1977
0.855
0.817
0.699
0.614
0.570
0.217
1978
0.214
0.207
0.175
0.147
0.138
0.072
1979
1.172
1.121
1.014
0.820
0.714
0.260
1980
1.395
1.333
1.185
1.032
0.875
0.319
1981
1.946
1.876
1.621
1.295
1.073
0.381
1982
0.290
0.280
0.258
0.222
0.220
0.124
1983
2.091
2.029
1.747
1.270
1.028
0.342
SORTED
FOR
PLOTTING
PROB
PEAK
96
HOUR
21
DAY
60
DAY
90
DAY
YEARLY
0.027
3.915
3.743
3.128
2.234
1.805
0.610
0.054
3.053
2.938
2.458
2.078
1.762
0.588
0.081
2.443
2.341
1.994
1.440
1.158
0.393
0.108
2.091
2.029
1.747
1.295
1.073
0.381
0.135
1.963
1.876
1.734
1.270
1.065
0.364
0.162
1.946
1.875
1.621
1.260
1.028
0.362
0.189
1.886
1.804
1.525
1.149
0.977
0.352
0.216
1.596
1.540
1.346
1.115
0.971
0.346
0.243
1.570
1.500
1.339
1.074
0.927
0.342
0.270
1.555
1.493
1.255
1.074
0.918
0.333
0.297
1.395
1.333
1.207
1.048
0.893
0.319
0.324
1.385
1.325
1.185
1.032
0.876
0.315
0.351
1.377
1.318
1.128
0.996
0.875
0.314
0.378
1.201
1.173
1.090
0.994
0.869
0.312
32
0.405
1.172
1.121
1.014
0.820
0.754
0.291
0.432
1.154
1.117
0.949
0.787
0.714
0.270
0.459
1.084
1.047
0.942
0.778
0.696
0.261
0.486
1.077
1.036
0.913
0.715
0.691
0.260
0.514
1.016
0.971
0.899
0.713
0.638
0.257
0.541
1.008
0.964
0.869
0.702
0.626
0.243
0.568
0.991
0.947
0.847
0.664
0.615
0.226
0.595
0.979
0.940
0.820
0.645
0.573
0.221
0.622
0.960
0.917
0.800
0.639
0.570
0.217
0.649
0.935
0.895
0.785
0.633
0.540
0.216
0.676
0.925
0.892
0.777
0.614
0.530
0.211
0.703
0.921
0.884
0.766
0.609
0.529
0.205
0.730
0.863
0.826
0.746
0.602
0.525
0.198
0.757
0.855
0.817
0.699
0.574
0.522
0.195
0.784
0.788
0.753
0.674
0.561
0.489
0.193
0.811
0.752
0.723
0.655
0.546
0.485
0.188
0.838
0.660
0.631
0.536
0.490
0.479
0.181
0.865
0.609
0.584
0.503
0.406
0.354
0.157
0.892
0.582
0.557
0.477
0.394
0.337
0.148
0.919
0.549
0.527
0.461
0.371
0.318
0.144
0.946
0.290
0.280
0.258
0.222
0.220
0.124
0.973
0.214
0.207
0.175
0.147
0.138
0.072
1/
10
2.197
2.123
1.821
1.339
1.099
0.384
MEAN
OF
ANNUAL
VALUES
=
0.272
STANDARD
DEVIATION
OF
ANNUAL
VALUES
=
0.113
UPPER
90%
CONFIDENCE
LIMIT
ON
MEAN
=
0.300
3,4
DCA
PRZM3.12
Input
File,
flcit.
inp
(
Jan
28
2000)
Location:
Osceola
County,
FL.;
Crop:
citrus;
MLRA
156A
0.77
0.15
0
25.00
1
1
4
0.10
0.13
1.00
10
4
1.00
345.0
1
1
0.10
100.00
80.00
3
94
84
89
0.00
100.00
1
3
0101
21
9
2209
0.10
0.10
0.10
.023
.023
.023
36
33
020148
030148
311248
1
020149
030149
311249
1
020150
030150
311250
1
020151
030151
311251
1
020152
030152
311252
1
020153
030153
311253
1
020154
030154
311254
1
020155
030155
311255
1
020156
030156
311256
1
020157
030157
311257
1
020158
030158
311258
1
020159
030159
311259
1
020160
030160
311260
1
020161
030161
311261
1
020162
030162
311262
1
020163
030163
311263
1
020164
030164
311264
1
020165
030165
311265
1
020166
030166
311266
1
020167
030167
311267
1
020168
030168
311268
1
020169
030169
311269
1
020170
030170
311270
1
020171
030171
311271
1
020172
030172
311272
1
020173
030173
311273
1
020174
030174
311274
1
020175
030175
311275
1
020176
030176
311276
1
020177
030177
311277
1
020178
030178
311278
1
020179
030179
311279
1
020180
030180
311280
1
020181
030181
311281
1
020182
030182
311282
1
020183
030183
311283
1
Application:
3,4
DCA:
One
ground
appl.
@
0.002
lb
a.
i./
ac
(
0.0022
Kg/
h)
@
99%
eff,
w/
6.4%
drift
36
1
0
0
3,4
DCA
010748
0
2
0.00
0.0022
0.99
0.064
010749
0
2
0.00
0.0022
0.99
0.064
010750
0
2
0.00
0.0022
0.99
0.064
010751
0
2
0.00
0.0022
0.99
0.064
010752
0
2
0.00
0.0022
0.99
0.064
010753
0
2
0.00
0.0022
0.99
0.064
010754
0
2
0.00
0.0022
0.99
0.064
010755
0
2
0.00
0.0022
0.99
0.064
010756
0
2
0.00
0.0022
0.99
0.064
010757
0
2
0.00
0.0022
0.99
0.064
010758
0
2
0.00
0.0022
0.99
0.064
34
010759
0
2
0.00
0.0022
0.99
0.064
010760
0
2
0.00
0.0022
0.99
0.064
010761
0
2
0.00
0.0022
0.99
0.064
010762
0
2
0.00
0.0022
0.99
0.064
010763
0
2
0.00
0.0022
0.99
0.064
010764
0
2
0.00
0.0022
0.99
0.064
010765
0
2
0.00
0.0022
0.99
0.064
010766
0
2
0.00
0.0022
0.99
0.064
010767
0
2
0.00
0.0022
0.99
0.064
010768
0
2
0.00
0.0022
0.99
0.064
010769
0
2
0.00
0.0022
0.99
0.064
010770
0
2
0.00
0.0022
0.99
0.064
010771
0
2
0.00
0.0022
0.99
0.064
010772
0
2
0.00
0.0022
0.99
0.064
010773
0
2
0.00
0.0022
0.99
0.064
010774
0
2
0.00
0.0022
0.99
0.064
010775
0
2
0.00
0.0022
0.99
0.064
010776
0
2
0.00
0.0022
0.99
0.064
010777
0
2
0.00
0.0022
0.99
0.064
010778
0
2
0.00
0.0022
0.99
0.064
010779
0
2
0.00
0.0022
0.99
0.064
010780
0
2
0.00
0.0022
0.99
0.064
010781
0
2
0.00
0.0022
0.99
0.064
010782
0
2
0.00
0.0022
0.99
0.064
010783
0
2
0.00
0.0022
0.99
0.064
0.00
1
0.00
0.00
0.000
0.50
Soil
Series:
Adamsville
sand;
Hydrogic
Group
C
100.00
0
0
0
0
0
0
0
0
0
0.0
0.00
00.00
3
1
10.000
1.440
0.086
0.000
0.000
0.000
.008
.008
0.000
0.100
0.086
0.036
0.580
14.00
2
10.000
1.440
0.086
0.000
0.000
0.000
.008
.008
0.000
1.000
0.086
0.036
0.580
14.00
3
80.000
1.580
0.030
0.000
0.000
0.000
.008
.008
0.000
5.000
0.030
0.023
0.116
14.00
0
WATR
YEAR
10
PEST
YEAR
10
CONC
YEAR
10
1
6
11
1
DAY
RUNF
TSER
0
0
1.
E0
OUTPUT
FILE
35
WATER
COLUMN
DISSOLVED
CONCENTRATION
(
PPB)
YEAR
PEAK
96
HOUR
21
DAY
60
DAY
90
DAY
YEARLY
1948
0.020
0.018
0.014
0.009
0.009
0.003
1949
0.011
0.010
0.008
0.006
0.005
0.001
1950
0.020
0.018
0.014
0.009
0.007
0.002
1951
0.060
0.053
0.034
0.017
0.012
0.004
1952
0.101
0.089
0.055
0.027
0.019
0.006
1953
0.026
0.023
0.019
0.013
0.010
0.003
1954
0.048
0.042
0.029
0.015
0.011
0.003
1955
0.019
0.017
0.011
0.007
0.006
0.002
1956
0.022
0.020
0.014
0.009
0.007
0.002
1957
0.064
0.056
0.043
0.026
0.019
0.005
1958
0.024
0.021
0.014
0.008
0.006
0.002
1959
0.028
0.025
0.018
0.012
0.010
0.003
1960
0.035
0.031
0.023
0.014
0.012
0.004
1961
0.013
0.011
0.008
0.005
0.004
0.001
1962
0.019
0.017
0.012
0.008
0.007
0.002
1963
0.022
0.020
0.016
0.010
0.008
0.002
1964
0.047
0.042
0.028
0.016
0.012
0.004
1965
0.018
0.016
0.012
0.009
0.008
0.003
1966
0.012
0.011
0.009
0.006
0.005
0.002
1967
0.033
0.029
0.018
0.014
0.011
0.003
1968
0.018
0.016
0.012
0.009
0.007
0.002
1969
0.031
0.027
0.017
0.013
0.010
0.003
1970
0.013
0.012
0.009
0.005
0.004
0.001
1971
0.013
0.011
0.007
0.005
0.005
0.002
1972
0.037
0.033
0.022
0.013
0.010
0.003
1973
0.012
0.010
0.009
0.007
0.006
0.002
1974
0.016
0.014
0.012
0.007
0.005
0.002
1975
0.022
0.019
0.012
0.007
0.005
0.002
1976
0.023
0.021
0.014
0.009
0.008
0.002
1977
0.015
0.014
0.010
0.007
0.006
0.002
1978
0.003
0.002
0.002
0.001
0.001
0.001
1979
0.026
0.022
0.016
0.010
0.008
0.002
1980
0.030
0.026
0.019
0.013
0.009
0.003
1981
0.045
0.042
0.028
0.018
0.014
0.004
1982
0.005
0.005
0.004
0.003
0.002
0.001
1983
0.051
0.047
0.032
0.016
0.011
0.003
SORTED
FOR
PLOTTING
PROB
PEAK
96
HOUR
21
DAY
60
DAY
90
DAY
YEARLY
36
0.027
0.101
0.089
0.055
0.027
0.019
0.006
0.054
0.064
0.056
0.043
0.026
0.019
0.005
0.081
0.060
0.053
0.034
0.018
0.014
0.004
0.108
0.051
0.047
0.032
0.017
0.012
0.004
0.135
0.048
0.042
0.029
0.016
0.012
0.004
0.162
0.047
0.042
0.028
0.016
0.012
0.004
0.189
0.045
0.042
0.028
0.015
0.011
0.003
0.216
0.037
0.033
0.023
0.014
0.011
0.003
0.243
0.035
0.031
0.022
0.014
0.011
0.003
0.270
0.033
0.029
0.019
0.013
0.010
0.003
0.297
0.031
0.027
0.019
0.013
0.010
0.003
0.324
0.030
0.026
0.018
0.013
0.010
0.003
0.351
0.028
0.025
0.018
0.013
0.010
0.003
0.378
0.026
0.023
0.017
0.012
0.009
0.003
0.405
0.026
0.022
0.016
0.010
0.009
0.003
0.432
0.024
0.021
0.016
0.010
0.008
0.003
0.459
0.023
0.021
0.014
0.009
0.008
0.002
0.486
0.022
0.020
0.014
0.009
0.008
0.002
0.514
0.022
0.020
0.014
0.009
0.008
0.002
0.541
0.022
0.019
0.014
0.009
0.007
0.002
0.568
0.020
0.018
0.014
0.009
0.007
0.002
0.595
0.020
0.018
0.012
0.009
0.007
0.002
0.622
0.019
0.017
0.012
0.008
0.007
0.002
0.649
0.019
0.017
0.012
0.008
0.006
0.002
0.676
0.018
0.016
0.012
0.007
0.006
0.002
0.703
0.018
0.016
0.012
0.007
0.006
0.002
0.730
0.016
0.014
0.011
0.007
0.006
0.002
0.757
0.015
0.014
0.010
0.007
0.005
0.002
0.784
0.013
0.012
0.009
0.007
0.005
0.002
0.811
0.013
0.011
0.009
0.006
0.005
0.002
0.838
0.013
0.011
0.009
0.006
0.005
0.002
0.865
0.012
0.011
0.008
0.005
0.005
0.001
0.892
0.012
0.010
0.008
0.005
0.004
0.001
0.919
0.011
0.010
0.007
0.005
0.004
0.001
0.946
0.005
0.005
0.004
0.003
0.002
0.001
0.973
0.003
0.002
0.002
0.001
0.001
0.001
1/
10
0.053
0.049
0.032
0.017
0.013
0.004
MEAN
OF
ANNUAL
VALUES
=
0.003
STANDARD
DEVIATION
OF
ANNUAL
VALUES
=
0.001
UPPER
90%
CONFIDENCE
LIMIT
ON
MEAN
=
0.003
37
mCPDMU
PRZM3.12
Input
File,
flcit.
inp
(
Jan
28
2000)
Location:
Osceola
County,
FL.;
Crop:
citrus;
MLRA
156A
0.77
0.15
0
25.00
1
1
4
0.10
0.13
1.00
172.8
4
1.00
600.0
1
1
0.10
100.00
80.00
3
94
84
89
0.00
100.00
1
3
0101
21
9
2209
0.10
0.10
0.10
.023
.023
.023
36
020148
030148
311248
1
020149
030149
311249
1
020150
030150
311250
1
020151
030151
311251
1
020152
030152
311252
1
020153
030153
311253
1
020154
030154
311254
1
020155
030155
311255
1
020156
030156
311256
1
020157
030157
311257
1
020158
030158
311258
1
020159
030159
311259
1
020160
030160
311260
1
020161
030161
311261
1
020162
030162
311262
1
020163
030163
311263
1
020164
030164
311264
1
020165
030165
311265
1
020166
030166
311266
1
020167
030167
311267
1
020168
030168
311268
1
020169
030169
311269
1
020170
030170
311270
1
020171
030171
311271
1
020172
030172
311272
1
020173
030173
311273
1
020174
030174
311274
1
020175
030175
311275
1
020176
030176
311276
1
020177
030177
311277
1
020178
030178
311278
1
020179
030179
311279
1
38
020180
030180
311280
1
020181
030181
311281
1
020182
030182
311282
1
020183
030183
311283
1
Application:
mCPDMU:
One
ground
appl.
@
2.04
lb
a.
i./
ac
(
2.28
Kg/
h)
@
99%
eff,
w/
6.4%
drift
36
1
0
0
mCPDMU
010748
0
2
0.00
2.28
0.99
0.064
010749
0
2
0.00
2.28
0.99
0.064
010750
0
2
0.00
2.28
0.99
0.064
010751
0
2
0.00
2.28
0.99
0.064
010752
0
2
0.00
2.28
0.99
0.064
010753
0
2
0.00
2.28
0.99
0.064
010754
0
2
0.00
2.28
0.99
0.064
010755
0
2
0.00
2.28
0.99
0.064
010756
0
2
0.00
2.28
0.99
0.064
010757
0
2
0.00
2.28
0.99
0.064
010758
0
2
0.00
2.28
0.99
0.064
010759
0
2
0.00
2.28
0.99
0.064
010760
0
2
0.00
2.28
0.99
0.064
010761
0
2
0.00
2.28
0.99
0.064
010762
0
2
0.00
2.28
0.99
0.064
010763
0
2
0.00
2.28
0.99
0.064
010764
0
2
0.00
2.28
0.99
0.064
010765
0
2
0.00
2.28
0.99
0.064
010766
0
2
0.00
2.28
0.99
0.064
010767
0
2
0.00
2.28
0.99
0.064
010768
0
2
0.00
2.28
0.99
0.064
010769
0
2
0.00
2.28
0.99
0.064
010770
0
2
0.00
2.28
0.99
0.064
010771
0
2
0.00
2.28
0.99
0.064
010772
0
2
0.00
2.28
0.99
0.064
010773
0
2
0.00
2.28
0.99
0.064
010774
0
2
0.00
2.28
0.99
0.064
010775
0
2
0.00
2.28
0.99
0.064
010776
0
2
0.00
2.28
0.99
0.064
010777
0
2
0.00
2.28
0.99
0.064
010778
0
2
0.00
2.28
0.99
0.064
010779
0
2
0.00
2.28
0.99
0.064
010780
0
2
0.00
2.28
0.99
0.064
010781
0
2
0.00
2.28
0.99
0.064
010782
0
2
0.00
2.28
0.99
0.064
010783
0
2
0.00
2.28
0.99
0.064
0.00
1
0.00
0.00
0.000
0.50
Soil
Series:
Adamsville
sand;
Hydrogic
Group
C
100.00
0
0
0
0
0
0
0
0
0
0.0
0.00
00.00
3
39
1
10.000
1.440
0.086
0.000
0.000
0.000
.002
.002
0.000
0.100
0.086
0.036
0.580
14.00
2
10.000
1.440
0.086
0.000
0.000
0.000
.002
.002
0.000
1.000
0.086
0.036
0.580
14.00
3
80.000
1.580
0.030
0.000
0.000
0.000
.002
.002
0.000
5.000
0.030
0.023
0.116
14.00
0
WATR
YEAR
10
PEST
YEAR
10
CONC
YEAR
10
1
6
11
1
DAY
RUNF
TSER
0
0
1.
E0
OUTPUT
FILE
WATER
COLUMN
DISSOLVED
CONCENTRATION
(
PPB)
YEAR
PEAK
96
HOUR
21
DAY
60
DAY
90
DAY
YEARLY
1948
32.350
31.270
28.580
26.250
25.600
10.820
1949
20.430
19.780
17.480
16.490
14.970
6.406
1950
30.210
29.200
26.920
24.990
22.810
9.550
1951
64.530
62.530
55.440
43.620
36.820
13.800
1952
101.000
97.580
85.300
66.550
56.590
21.830
1953
42.340
40.950
36.420
33.030
30.490
13.130
1954
53.770
51.970
48.960
38.780
34.920
13.490
1955
29.250
28.280
24.900
20.960
19.010
8.566
1956
34.720
33.720
30.750
25.410
21.720
8.536
1957
83.620
81.380
71.240
63.710
57.110
21.030
1958
28.420
27.790
25.390
21.560
20.230
8.797
1959
37.580
36.330
32.620
30.960
29.580
11.640
1960
59.290
57.380
53.630
43.530
36.820
14.270
1961
19.820
19.170
16.830
15.030
13.470
6.971
1962
31.500
30.450
28.390
23.710
20.470
8.866
1963
40.600
39.290
35.770
28.440
23.760
9.124
1964
69.330
67.030
58.670
47.210
41.530
15.710
1965
34.410
33.300
29.830
25.250
23.590
11.500
1966
25.380
24.540
21.700
18.560
16.350
7.429
1967
46.930
45.830
40.590
36.480
33.000
13.160
1968
33.720
32.610
30.210
24.360
22.080
9.560
1969
43.810
42.360
39.240
33.060
30.250
11.660
1970
25.170
24.360
21.530
16.640
14.080
6.370
1971
23.670
23.210
21.000
18.120
17.030
7.783
40
1972
43.930
42.870
39.050
34.580
31.170
11.470
1973
27.960
27.150
24.940
21.080
19.000
8.558
1974
30.230
29.220
26.450
21.250
18.500
7.341
1975
26.370
25.490
22.160
19.640
17.620
7.440
1976
39.500
38.450
34.010
27.280
23.660
10.120
1977
24.680
23.900
21.020
20.040
19.050
8.284
1978
7.142
6.964
6.320
5.438
5.252
3.313
1979
35.850
34.660
30.260
26.710
24.580
9.927
1980
40.150
39.140
36.000
34.330
30.380
11.950
1981
66.900
64.670
58.060
49.800
42.500
15.460
1982
13.060
12.680
11.770
9.561
9.106
5.719
1983
59.320
58.200
51.850
40.740
34.350
12.150
SORTED
FOR
PLOTTING
PROB
PEAK
96
HOUR
21
DAY
60
DAY
90
DAY
YEARLY
0.027
101.000
97.580
85.300
66.550
57.110
21.830
0.054
83.620
81.380
71.240
63.710
56.590
21.030
0.081
69.330
67.030
58.670
49.800
42.500
15.710
0.108
66.900
64.670
58.060
47.210
41.530
15.460
0.135
64.530
62.530
55.440
43.620
36.820
14.270
0.162
59.320
58.200
53.630
43.530
36.820
13.800
0.189
59.290
57.380
51.850
40.740
34.920
13.490
0.216
53.770
51.970
48.960
38.780
34.350
13.160
0.243
46.930
45.830
40.590
36.480
33.000
13.130
0.270
43.930
42.870
39.240
34.580
31.170
12.150
0.297
43.810
42.360
39.050
34.330
30.490
11.950
0.324
42.340
40.950
36.420
33.060
30.380
11.660
0.351
40.600
39.290
36.000
33.030
30.250
11.640
0.378
40.150
39.140
35.770
30.960
29.580
11.500
0.405
39.500
38.450
34.010
28.440
25.600
11.470
0.432
37.580
36.330
32.620
27.280
24.580
10.820
0.459
35.850
34.660
30.750
26.710
23.760
10.120
0.486
34.720
33.720
30.260
26.250
23.660
9.927
0.514
34.410
33.300
30.210
25.410
23.590
9.560
0.541
33.720
32.610
29.830
25.250
22.810
9.550
0.568
32.350
31.270
28.580
24.990
22.080
9.124
0.595
31.500
30.450
28.390
24.360
21.720
8.866
0.622
30.230
29.220
26.920
23.710
20.470
8.797
0.649
30.210
29.200
26.450
21.560
20.230
8.566
0.676
29.250
28.280
25.390
21.250
19.050
8.558
0.703
28.420
27.790
24.940
21.080
19.010
8.536
0.730
27.960
27.150
24.900
20.960
19.000
8.284
0.757
26.370
25.490
22.160
20.040
18.500
7.783
0.784
25.380
24.540
21.700
19.640
17.620
7.440
0.811
25.170
24.360
21.530
18.560
17.030
7.429
0.838
24.680
23.900
21.020
18.120
16.350
7.341
0.865
23.670
23.210
21.000
16.640
14.970
6.971
41
0.892
20.430
19.780
17.480
16.490
14.080
6.406
0.919
19.820
19.170
16.830
15.030
13.470
6.370
0.946
13.060
12.680
11.770
9.561
9.106
5.719
0.973
7.142
6.964
6.320
5.438
5.252
3.313
1/
10
67.629
65.378
58.243
47.987
41.821
15.535
MEAN
OF
ANNUAL
VALUES
=
10.604
STANDARD
DEVIATION
OF
ANNUAL
VALUES
=
3.895
UPPER
90%
CONFIDENCE
LIMIT
ON
MEAN
=
11.565
APPENDIX
II
SCI
GROW
OUTPUT
FILES
FOE
MODELING
DIURON
AND
ITS
DEGRADATES
RUN
No.
1
FOR
diuron
INPUT
VALUES
APPL
(#/
AC)
APPL.
URATE
SOIL
SOIL
AEROBIC
RATE
NO.
(#/
AC/
YR)
KOC
METABOLISM
(
DAYS)
42
9.600
1
9.600
468.0
372.0
GROUND
WATER
SCREENING
CONCENTRATIONS
IN
PPB
6.521987
A=
367.000
B=
473.000
C=
2.565
D=
2.675
RILP=
3.399
F=
.
168
G=
.679
URATE=
9.600
GWSC=
6.521987
RUN
No.
1
FOR
DCPMU
INPUT
VALUES
APPL
(#/
AC)
APPL.
URATE
SOIL
SOIL
AEROBIC
RATE
NO.
(#/
AC/
YR)
KOC
METABOLISM
(
DAYS)
2.030
1
2.030
468.0
770.0
GROUND
WATER
SCREENING
CONCENTRATIONS
IN
PPB
2.497237
A=
765.000
B=
473.000
C=
2.884
D=
2.675
RILP=
3.821
F=
.090
G=
1.230
URATE=
2.030
GWSC=
2.497237
RUN
No.
2
FOR
DCPU
INPUT
VALUES
43
APPL
(#/
AC)
APPL.
URATE
SOIL
SOIL
AEROBIC
RATE
NO.
(#/
AC/
YR)
KOC
METABOLISM
(
DAYS)
.080
1
.080
468.0
770.0
GROUND
WATER
SCREENING
CONCENTRATIONS
IN
PPB
.098413
A=
765.000
B=
473.000
C=
2.884
D=
2.675
RILP=
3.821
F=
.090
G=
1.230
URATE=
.080
GWSC=
.098413
RUN
No.
3
FOR
3,4
DCA
INPUT
VALUES
APPL
(#/
AC)
APPL.
URATE
SOIL
SOIL
AEROBIC
RATE
NO.
(#/
AC/
YR)
KOC
METABOLISM
(
DAYS)
.002
1
.002
468.0
30.0
GROUND
WATER
SCREENING
CONCENTRATIONS
IN
PPB
.000155
A=
25.000
B=
473.000
C=
1.398
D=
2.675
RILP=
1.852
F=
1.111
G=
.077
URATE=
.002
GWSC=
.000155
44
RUN
No.
4
FOR
mCPDMU
INPUT
VALUES
APPL
(#/
AC)
APPL.
URATE
SOIL
SOIL
AEROBIC
RATE
NO.
(#/
AC/
YR)
KOC
METABOLISM
(
DAYS)
1.120
1
1.120
468.0
115.0
GROUND
WATER
SCREENING
CONCENTRATIONS
IN
PPB
.287307
A=
110.000
B=
473.000
C=
2.041
D=
2.675
RILP=
2.705
F=
.
591
G=
.257
URATE=
1.120
GWSC=
.287307
45
46
14.
Cullington,
J.
E.,
and
A.
Walker.
1998.
Rapid
degradation
of
diuron,
and
other
phenylurea
herbicides
by
a
soil
bacterium.
Soil
Biology
and
Biochemistry.
31:
677
686.
15.
9.
Rouchaud
J.,
O.
Neus,
R.
Bulcke,
K.
Cools,
H.
Eelen,
and
T.
Dekkers.
2000.
Soil
dissipation
of
diuron,
chlorotoluron,
simazine,
propyzamide,
and
diflufenican
herbicides
after
repeated
applications
in
fruit
tree
orchards.
Archives
of
Environmental
Contamination
and
Toxicology.
39(
1):
60
65.
10.
Linuron
Reregistration
Eligibility
Decision.
1994.
United
States
Environmental
Protection
Agency
,
Office
of
Prevention,
Pesticides
And
Toxic
Substances,
[
Online]
at
http://
www.
epa.
gov/
oppsrrd1/
REDs/
0047.
pdf.
Diuron
Surface
Water
Monitoring
Data
Location
Duration
of
Sampling
(
sampling
frequency)
Number
of
samples
(%
detections)
Max
detection
(
ppb)
47
CA
(
mostly
creeks
and
rivers)
1
Nov.
1996
April
1998
for
most
samples
(
sampling
every
2
weeks)
307
(
48
%)
30.6
CA
(
runoff
studies
from
right
of
way
use
edge
of
plot
data)
2
September
1991
November
1991
(
sampling
during
runoff
events)
47
(
100
%)
2849
(
of
three
studies)
LA
(
mostly
creeks,
bayous
and
rivers)
3
May
1999
May
2000
(
sampling
every
2
weeks
to
one
month)
83
(
70
%)
3.65
(
estimated)
0.48
(
confirmed)
MS,
MO,
TN,
AR,
and
North
LA
(
mostly
creeks,
bayous
and
rivers)
4
February
1996
February
2001
(
sampling
every
2
weeks
to
one
month)
219
(
52
%)
2.1
(
estimated)
0.98
(
confirmed)
1
CA
Department
of
Pesticide
Regulation's
surface
water
database,
as
of
July
15,
2000
SWDB
study
37.
Nordmark,
Craig.
1998.
Preliminary
results
of
acute
and
chronic
toxicity
testing
of
surface
water
monitored
in
the
Sacramento
River
watershed,
winter
1997
98.
Memorandum
to
Don
Weaver,
Environmental
Monitoring
and
Pest
Management,
Department
of
Pesticide
Regulation,
Sacramento,
California.
July
31,
1998.
SWDB
study
41.
Domagalski,
J.,
In
Prep.
Pesticide
monitoring
in
the
Sacramento
River
Basin,
California,
2/
96
9/
98.
USGS
National
Water
Quality
Assessment
Program.
USGS
report
in
preparation.
SWDB
study
43.
Foe,
C.
1993.
Pesticides
in
surface
water
from
applications
on
orchards
and
alfalfa
during
the
winter
and
spring
of
1991
92.
Central
Valley
Regional
Water
Quality
Control
Board,
Sacramento,
California.
February
1993.
SWDB
study
51.
Sacramento
Area
Stormwater
NPDES
Permit
Monitoring
Program:
1990,
1991,
1992,
1994
95
and
1995
96.
Submitted
to
County
of
Sacramento
and
cities
of
Sacramento,
Folsom
and
Galt
by
Larry
Walker
and
Associates,
Davis
California.
48
SWDB
study
57.
Nordmark,
Craig.
1999.
Preliminary
results
of
acute
and
chronic
toxicity
testing
of
surface
water
monitored
in
the
Sacramento
River
watershed,
winter
1998
99.
Memorandum
to
Don
Weaver,
Environmental
Monitoring
and
Pest
Management,
Department
of
Pesticide
Regulation,
Sacramento,
California.
May
26,
1999.
SWDB
study
63.
Nordmark,
Craig.
In
prep.
Preliminary
results
of
acute
and
chronic
toxicity
testing
of
surface
water
monitored
in
the
Sacramento
River
watershed,
winter
1999
00.
Memorandum
to
Don
Weaver,
Environmental
Monitoring
and
Pest
Management,
Department
of
Pesticide
Regulation,
Sacramento,
California.
2
Powell,
S.,
R.
Neal,
and
J.
Leyva.
1996.
Runoff
and
Leaching
of
Simazine
and
Diuron
used
on
Highway
Rights
of
Way.
CAL
DPR
Report
No.
EH
96
03,
www.
cdpr.
ca.
ca.
gov/
empm/
pubs/
chapreps/
e9603.
htm.
3
Walters,
D.
2001.
USGS
Spreadsheet
"
Breithaupt.
xls"
sent
to
James
Breithaupt
of
OPP/
EFED
on
5/
23/
2001
in
Response
to
Data
Request.
4
Coupe,
Richard
H.
2001.
USGS
Spreadsheet
"
EPA.
xls"
sent
to
James
Breithaupt
of
OPP/
EFED
on
4/
12/
2001
in
Response
to
Data
Request.
5
Harris,
Jennifer.
2001.
USGS
Spreadsheet
"
DCA.
xls"
sent
to
James
Breithaupt
of
OPP/
EFED
on
5/
21/
2001
in
Response
to
Data
Request.
Discussion
of
the
Surface
Water
Monitoring
Results
for
the
Common
Diuron,
Linuron,
and
Propanil
Degradate
3,4
Dichloroaniline
(
3,4
DCA)
Diuron,
linuron,
and
propanil
have
a
common
degradate,
3,4
DCA.
In
MS,
MO,
TN,
AR,
and
North
LA,
3,4
DCA
did
not
exceed
8.9
ppb
in
surface
water
(
49
%
detection
rate,
68
samples)
(
Harris,
2001).
In
South
Louisiana,
there
were
only
three
samples
for
3,4
DCA,
with
a
maximum
concentration
of
0.06
ppb
(
Walters,
2001).
Any
DCA
present
in
MS,
MO,
TN,
AR,
and
North
LA
is
likely
to
be
a
result
of
both
diuron
and
propanil
applications
due
to
both
cotton
and
rice
being
produced.
In
South
Louisiana,
any
3,4
DCA
present
would
most
likely
be
from
applied
propanil
to
rice.
| epa | 2024-06-07T20:31:43.535473 | regulations | {
"license": "Public Domain",
"url": "https://downloads.regulations.gov/EPA-HQ-OPP-2002-0249-0006/content.txt"
} |
EPA-HQ-OPP-2002-0249-0007 | Supporting & Related Material | "2002-10-01T04:00:00" | null | UNITED
STATES
ENVIRONMENTAL
PROTECTION
AGENCY
WASHINGTON,
D.
C.
20460
OFFICE
OF
PREVENTION,
PESTICIDES
AND
TOXIC
SUBSTANCES
PC
Code:
035505
DP
Barcode:
D281404
MEMORANDUM
March
11,
2002
SUBJECT:
Drinking
Water
Reassessment
for
diuron
and
its
degradates
TO:
Diana
Locke
Reregistration
Actions
Branch
II
Health
Effects
Division
(
7509C)
FROM:
Ibrahim
Abdel
Saheb/
Agronomist
Environmental
Risk
Branch
II
Environmental
Fate
and
Effects
Division
(
7507C)
PEER
REVIEW:
Sid
Abel/
Environmental
Scientist
Environmental
Risk
Branch
II
Environmental
Fate
and
Effects
Division
(
7507C)
THRU:
Tom
Bailey,
Branch
Chief
Environmental
Risk
Branch
II
Environmental
Fate
and
Effects
Division
(
7507C)
CONCLUSIONS
This
memorandum
transmits
re
calculated
estimated
drinking
water
concentrations
for
use
in
the
human
health
risk
assessment.
Griffin
Label
(
EPA
Reg.
No.
1812
362)
was
used
to
determine
the
estimated
concentrations.
The
Tier
II
screening
models
PRZM1
and
EXAMS2
were
rerun
using
the
Index
Reservoir
and
Percent
Crop
Area
adjustment
to
2
determine
estimated
surface
water
concentrations
of
diuron
and
its
degradates
dichlorophenylmethylurea
(
DCPMU);
dichlorophenylurea
(
DCPU);
3,4
dichloraniline
(
3,4
DCA);
and
N'(
3
chlorophenyl)
N
Ndimethylurea
(
mCPDMU).
The
Screening
Concentration
in
Groundwater
(
SCI
GROW3)
model
was
used
to
estimate
groundwater
concentrations
for
Diuron
and
its
degradates.
Modeling
results
are
shown
in
Table
1.
Table
1.
Estimated
environmental
concentrations
in
surface
and
groundwater
for
diuron
and
its
degradates
use
on
citrus.
Toxicity
end
point
model
EECs
(
F
g/
L)
use(
s)
modeled
PCA
Diuron
DCPMU
DCPU
3,4
DCA
mCPDMU
one
application
of
diuron
on
citrus
@
9.6
lb
ai/
acre,
ground
application
Default
(
0.87)
Surface
water/
peak
613
130
5.80
0.08
136
Surface
water/
1
10
year
average)
128
27.0
1.20
0.02
36.4
Surface
water/
mean
of
annual
values)
85.0
18.0
0.80
0.01
25.5
Groundwater/
(
peak
and
long
term
average)
6.5
2.50
0.1
2X10
4
1.38
The
IR
PCA
modeling
results
indicate
that
diuron
and
its
degradates
have
the
potential
to
contaminate
surface
waters
by
runoff
in
areas
with
large
amounts
of
annual
rainfall.
The
degradate
3,4
DCA
is
commonly
seen
in
surface
water
in
areas
with
high
diuron
and
propanil
usage,
however,
EFED
has
received
no
guideline
studies
on
the
environmental
fate
and
transport
of
3,4
DCA
or
other
degradate
of
diuron.
EFED
believes
that
additional
studies
are
needed
to
fully
understand
both
the
fate
and
transport
of
these
compounds
in
the
environment.
Modeling
results
were
higher
than
data
from
existing
diuron
surface
water
monitoring
studies
targeted
to
the
pesticide
use
area.
Modeling
values
where
several
orders
of
magnitude
(
ranging
from
9
100
times)
higher
than
monitoring
data.
Major
degradates
that
were
determined
by
HED
to
be
of
toxicological
concern
include:
dichlorophenylmethylurea
(
DCPMU),
3
dichlorophenylurea
(
DCPU),
3,4
dichloroaniline
(
3,4
DCA),
and
N'(
3
chlorophenyl)
N
N
dimethylurea
(
mCPDMU)].
Because
the
EFED
lacks
complete
environmental
fate
data
(
such
as
the
aerobic
aquatic
and
anaerobic
aquatic
studies)
on
these
degradates,
this
memorandum
addresses
the
estimated
environmental
concentrations
(
EEC's)
for
surface
and
groundwater
based
on
half
lives
that
were
calculated
on
cumulative
residues.
Usage
map
for
diuron4
is
attached.
Surface
Water
Monitoring
The
EFED
has
targeted,
but,
limited
monitoring
data
on
the
concentrations
of
diuron
and
its
degradates
in
surface
water.
A
study
on
the
occurrence
of
cotton
herbicides
and
insecticides
in
Playa
lakes
of
the
high
plains
of
western
Texas
concluded
that
diuron
was
the
major
pesticide
detected
in
water
samples
collected
from
32
lakes
with
a
mean
concentration
of
2.7
ppb.
Diuron
metabolites
(
DCPMU,
DCPU,
and
3,4
DCA)
were
found
in
71%
of
the
samples
analyzed.
The
mean
concentrations
of
these
metabolites
were
0.45
ppb
for
DCPMU,
0.31
ppb
for
3,4
DCA,
and
0.2
ppb
for
DCPU5.
In
this
study,
water
samples
were
taken
within
two
days
after
diuron
application
to
cotton
in
the
region.
Diuron
usage
on
cotton
in
this
part
of
the
state
reached
an
average
of
$
1.379
lb
ai/
mile2/
yr.
Even
though,
the
monitoring
of
diuron
concentrations
from
use
on
Cotton
in
this
part
of
the
state
is
an
example
of
a
targeted
study,
the
frequency
of
surface
water
sampling
and
the
length
of
sampling
period
were
insufficient
to
satisfy
the
temporal
and
spatial
requirements
for
regulatory
purposes.
This
study
has
limited
use
in
a
national
assessment
because
we
do
not
expect
western
Texas
to
be
one
of
the
most
vulnerable
use
areas
for
runoff.
However,
because
the
samples
were
taken
within
two
days
after
application,
the
results
may
represent
a
lower
bound
of
possible
peak
concentrations
that
could
occur
in
drinking
water
in
that
area.
The
US
Geological
Survey
(
USGS)
National
Water
Quality
Assessment
Program
(
NAWQA)
collected
1420
surface
water
samples
4
from
62
agricultural
stream
sites
during
the
period
from
1992
1998.
One
to
two
samples
was
collected
each
month
during
periods
when
pesticide
transport
in
the
streams
was
expected
to
be
low
throughout
the
year.
At
most
sites,
the
sampling
frequency
was
increased
to
1
to
3
samples
per
week
during
periods
when
elevated
levels
of
pesticides
were
expected
in
the
streams.
Diuron
was
detected
in
7.32%
of
the
samples
(
detection
limit
=
0.05
ppb)
with
concentration
of
0.13
ppb
in
95%
of
samples.
Diuron
maximum
concentration
was
13
ppb
(
estimated
concentration)
6.
Modeling
Tier
II
surface
water
modeling
was
done
using
the
Index
Reservoir
(
IR)
and
Percent
Crop
Area
(
PCA)
modifications
to
PRZM
and
EXAMS.
The
index
reservoir
represents
a
potential
vulnerable
drinking
water
source
from
a
specific
area
(
Illinois)
with
specific
cropping
patterns,
weather,
soils,
and
other
factors.
The
PCA
is
a
generic
watershed
based
adjustment
factor
which
represent
the
portion
of
a
watershed
planted
to
a
crop
or
crops
and
will
be
applied
to
pesticide
concentrations
estimated
for
the
surface
water
component
of
the
drinking
water
exposure
assessment
using
PRZM/
EXAMS
with
the
index
reservoir
scenario7.
The
IR
PCA
PRZM/
EXAMS
model
use
and
fate
input
parameters
for
diuron
and
its
degradates
in
surface
water
are
shown
in
Tables
2
6.
The
IR
PC
PRZM/
EXAMS
model
input
and
output
files
for
diuron
and
its
degradates
are
shown
in
Appendix
I.
5
Table
2:
IR
PC
PRZM/
EXAMS
input
parameters
for
diuron.
Input
variable
Input
value
&
calculations
Source/
Quality
of
data
Crop
name
citrus
label
(
EPA
Reg.
No.
1812
362).
application
rate
(
lb
ai/
acre)
9.6
label
(
EPA
Reg.
No.
1812
362).
Application
efficiency
0.99
IR
PC
Guidance8
Spray
drift
fraction
0.064
IR
PC
Guidance
Application
method
ground
label
(
EPA
Reg.
No.
1812
362).
DWRATE
(
day
1)
0.0006
MRID#
41719303;
Input
parameters
guidance8
DSRATE
(
day
1)
0.0006
MRID#
41719303;
Input
parameters
guidance
Kd
(
mL/
g)
14
MRID#
44490501;
Input
parameters
guidance
Henry
(
atm.
m3/
mole)
2.2X10
10
(
calculated)
Product
Chemistry
chapter
for
HED
RED,
2001.
KBACW
(
h
1)
0.0003
Aerobic
aquatic
met.
t
½
was
multiplied
by
3.
MRID#
42260501.
Input
parameters
guidance.
KBACS
(
h
1)
0.002
aquatic
met.
t
½
was
multiplied
by
3.
MRID#
MRID#
42661901.
Input
parameters
guidance.
KDP
(
h
1)
0.0007
MRID#
41418805;
Input
parameters
guidance.
KBH,
KNH,
KAH
(
h
1)
0
(
stable)
MRID#
41418804.
KPS
(
mL/
g)
16.6
MRID#
44490501;
Input
parameters
guidance.
6
MWT
(
g/
mole)
233.1
The
MERCK
INDEX9
Solubility
@
25
0C
(
ppm)
420
Product
Chemistry
chapter
for
HED
RED,
2001;
Input
parameters
guidance.
Vapor
pressure
(
torr)
2.0X10
7
Product
Chemistry
chapter
for
HED
RED,
2001.
7
Table
3:
IR
PC
PRZM/
EXAMS
input
parameters
for
DCPMU.
Input
variable
Input
value
&
calculations
Source/
Quality
of
data
Crop
name
citrus
label
(
EPA
Reg.
No.
1812
362).
application
rate
(
lb
ai/
acre)
2.03
label
(
EPA
Reg.
No.
1812
362).
An
equivalent
value
based
on
maximum
conversion
of
diuron
to
degradates
and
the
molecular
weight
ratio
adjustment.
Application
efficiency
0.99
IR
PC
Guidance
Spray
drift
fraction
0.064
IR
PC
Guidance
Application
method
ground
label
(
EPA
Reg.
No.
1812
362).
DWRATE
(
day
1)
0.0003
MRID#
41719303;
Input
parameters
guidance8
DSRATE
(
day
1)
0.0003
MRID#
41719303;
Input
parameters
guidance
Kd
(
mL/
g)
for
diuron:
14
MRID#
44490501;
Input
parameters
guidance
Henry
(
atm.
m3/
mole)
for
diuron:
2.2X10
10
(
calculated)
Product
Chemistry
chapter
for
HED
RED,
2001.
KBACW
(
h
1)
for
diuron:
0.0003
No
aerobic
aquatic
data
is
available,
diruon
t
½
was
multiplied
by
3,
MRID#
41719303.
Input
parameters
guidance.
KBACS
(
h
1)
for
diuron:
0.002
No
anaerobic
aquatic
data
is
available,
the
anaerobic
soil
met.
t
½
was
multiplied
by
0.5.
MRID#
41418806.
Input
parameters
guidance.
KDP
(
h
1)
for
diuron:
0.0007
MRID#
41418805;
Input
parameters
guidance.
KBH,
KNH,
KAH
(
h
1)
for
diuron:
0
(
stable)
MRID#
41418804.
KPS
(
mL/
g)
for
diuron:
16.6
MRID#
44490501;
Input
parameters
guidance.
MWT
(
g/
mole)
219.1
The
MERCK
INDEX
Solubility
@
25
0C
(
ppm)
for
diuron:
420
Product
Chemistry
chapter
for
HED
RED,
2001;
Input
parameters
guidance.
8
Vapor
pressure
(
torr)
for
diuron:
2.0X10
7
Product
Chemistry
chapter
for
HED
RED,
2001.
Table
4:
IR
PC
PRZM/
EXAMS
input
parameters
for
DCPU.
Input
variable
Input
value
&
calculations
Source/
Quality
of
data
Crop
name
citrus
label
(
EPA
Reg.
No.
1812
362).
application
rate
(
lb
ai/
acre)
0.08
label
(
EPA
Reg.
No.
1812
362).
An
equivalent
value
based
on
maximum
conversion
of
diuron
to
degradates
and
the
molecular
weight
ratio
adjustment.
Application
efficiency
0.99
IR
PC
Guidance
Spray
drift
fraction
0.064
IR
PC
Guidance
Application
method
ground
label
(
EPA
Reg.
No.
1812
362).
DWRATE
(
day
1)
0.0003
MRID#
41719303;
Input
parameters
guidance8
DSRATE
(
day
1)
0.0003
MRID#
41719303;
Input
parameters
guidance
Kd
(
mL/
g)
for
diuron:
14
MRID#
44490501;
Input
parameters
guidance
Henry
(
atm.
m3/
mole)
for
diuron:
2.2X10
10
(
calculated)
Product
Chemistry
chapter
for
HED
RED,
2001.
KBACW
(
h
1)
for
diuron:
0.0003
No
aerobic
aquatic
data
is
available,
diruon
t
½
was
multiplied
by
3,
MRID#
41719303.
Input
parameters
guidance.
KBACS
(
h
1)
for
diuron:
0.002
No
anaerobic
aquatic
data
is
available,
the
anaerobic
soil
met.
t
½
was
multiplied
by
0.5.
MRID#
41418806.
Input
parameters
guidance.
KDP
(
h
1)
for
diuron:
0.0007
MRID#
41418805;
Input
parameters
guidance.
KBH,
KNH,
KAH
(
h
1)
for
diuron:
0
(
stable)
MRID#
41418804.
9
KPS
(
mL/
g)
for
diuron:
16.6
MRID#
44490501;
Input
parameters
guidance.
MWT
(
g/
mole)
205.1
The
MERCK
INDEX
Solubility
@
25
0C
(
ppm)
for
diuron:
420
Product
Chemistry
chapter
for
HED
RED,
2001;
Input
parameters
guidance.
Vapor
pressure
(
torr)
for
diuron:
2.0X10
7
Product
Chemistry
chapter
for
HED
RED,
2001.
Table
5:
IR
PC
PRZM/
EXAMS
input
parameters
for
3,4
DCA.
Input
variable
Input
value
&
calculations
Source/
Quality
of
data
Crop
name
citrus
label
(
EPA
Reg.
No.
1812
362).
application
rate
(
lb
ai/
acre)
0.0021
label
(
EPA
Reg.
No.
1812
362).
An
equivalent
value
based
on
maximum
conversion
of
diuron
to
degradates
and
the
molecular
weight
ratio
adjustment.
Application
efficiency
0.99
IR
PC
Guidance7
Spray
drift
fraction
0.064
IR
PC
Guidance
Application
method
ground
label
(
EPA
Reg.
No.
1812
362).
DWRATE
(
day
1)
0.008
MRID#
41719303;
Input
parameters
guidance8
DSRATE
(
day
1)
0.008
MRID#
41538701;
Input
parameters
guidance
Kd
(
mL/
g)
for
diuron:
14
MRID#
44490501;
Input
parameters
guidance
Henry
(
atm.
m3/
mole)
for
diuron:
2.2X10
10
(
calculated)
Product
Chemistry
chapter
for
HED
RED,
2001.
KBACW
(
h
1)
for
diuron:
0.0003
No
aerobic
a
q
u
a
t
i
c
d
a
t
a
i
s
available,
diruon
t
½
was
multiplied
by
3,
MRID#
41719303.
Input
parameters
guidance.
KBACS
(
h
1)
for
diuron:
0.002
No
anaerobic
aquatic
data
is
available,
the
anaerobic
soil
met.
t
½
was
multiplied
by
0.5.
MRID#
41418806.
Input
parameters
guidance.
10
KDP
(
h
1)
for
diuron:
0.0007
MRID#
41418805;
Input
parameters
guidance.
KBH,
KNH,
KAH
(
h
1)
for
diuron:
0
(
stable)
MRID#
41418804.
KPS
(
mL/
g)
for
diuron:
16.6
MRID#
44490501;
Input
parameters
guidance.
MWT
(
g/
mole)
162.1
The
MERCK
INDEX
Solubility
@
25
0C
(
ppm)
for
diuron:
420
Product
Chemistry
chapter
for
HED
RED,
2001;
Input
parameters
guidance.
Vapor
pressure
(
torr)
for
diuron:
2.0X10
7
Product
Chemistry
chapter
for
HED
RED,
2001.
Table
6:
IR
PC
PRZM/
EXAMS
input
parameters
for
mPDMU.
Input
variable
Input
value
&
calculations
Source/
Quality
of
data
Crop
name
citrus
label
(
EPA
Reg.
No.
1812
362).
application
rate
(
lb
ai/
acre)
2.04
label
(
EPA
Reg.
No.
1812
362).
An
equivalent
value
based
on
maximum
conversion
of
diuron
to
degradates
and
the
molecular
weight
ratio
adjustment.
Application
efficiency
0.99
IR
PC
Guidance
Spray
drift
fraction
0.064
IR
PC
Guidance
Application
method
ground
label
(
EPA
Reg.
No.
1812
362).
DWRATE
(
day
1)
for
diuron:
0.0006
MRID#
41719303;
Input
parameters
guidance8
DSRATE
(
day
1)
for
diuron:
0.0006
MRID#
41719303;
Input
parameters
guidance
Kd
(
mL/
g)
for
diuron:
14
MRID#
44490501;
Input
parameters
guidance
Henry
(
atm.
m3/
mole)
for
diuron:
2.2X10
10
(
calculated)
Product
Chemistry
chapter
for
HED
RED,
2001.
KBACW
(
h
1)
0.00008
MRID#
42661901.
Input
parameters
guidance.
11
KBACS
(
h
1)
0.00005
MRID#
42260501.
Input
parameters
guidance.
KDP
(
h
1)
for
diuron:
0.0007
MRID#
41418805;
Input
parameters
guidance.
KBH,
KNH,
KAH
(
h
1)
for
diuron:
0
(
stable)
MRID#
41418804.
KPS
(
mL/
g)
for
diuron:
16.6
MRID#
44490501;
Input
parameters
guidance.
MWT
(
g/
mole)
198.1
The
MERCK
INDEX
Solubility
@
25
0C
(
ppm)
for
diuron:
420
Product
Chemistry
chapter
for
HED
RED,
2001;
Input
parameters
guidance.
Vapor
pressure
(
torr)
for
diuron:
2.0X10
7
Product
Chemistry
chapter
for
HED
RED,
2001.
Assumptions
and
Uncertainties7,10
Index
Reservoir
The
index
reservoir
represents
potential
drinking
water
exposure
from
a
specific
area
(
Illinois)
with
specific
cropping
patterns,
weather,
soils,
and
other
factors.
Use
of
the
index
reservoir
for
areas
with
different
climates,
crops,
pesticides
used,
sources
of
water
(
e.
g.
rivers
instead
of
reservoirs,
etc),
and
hydrogeology
creates
uncertainties.
In
general,
because
the
index
reservoir
represents
a
fairly
vulnerable
watershed,
the
exposure
estimated
with
the
index
reservoir
will
likely
be
higher
than
the
actual
exposure
for
most
drinking
water
sources.
However,
the
index
reservoir
is
not
a
worst
case
scenario,
communities
that
derive
their
drinking
water
from
smaller
bodies
of
water
with
minimal
outflow,
or
with
more
runoff
prone
soils
would
likely
get
higher
drinking
water
exposure
than
estimated
using
the
index
reservoir.
Areas
with
a
more
humid
climate
that
use
a
similar
reservoir
and
cropping
patterns
may
also
get
more
pesticides
in
their
drinking
water
than
predicted
using
this
scenario.
A
single
steady
flow
has
been
used
to
represent
the
flow
through
the
reservoir.
Discharge
from
the
reservoir
also
removes
chemical
so
this
assumption
will
underestimate
removal
from
the
12
reservoir
during
wet
periods
and
overestimates
removal
during
dry
periods.
This
assumption
can
both
underestimate
or
overestimate
the
concentration
in
the
pond
depending
upon
the
annual
precipitation
pattern
at
the
site.
The
index
reservoir
scenario
uses
the
characteristics
of
a
single
soil
to
represent
the
soil
in
the
basin.
In
fact,
soils
can
vary
substantially
across
even
small
areas,
and
this
variation
is
not
reflected
in
these
simulations.
The
index
reservoir
scenario
does
not
consider
tile
drainage.
Areas
that
are
prone
to
substantial
runoff
are
often
tile
drained.
Tile
drainage
contributes
additional
water
and
in
some
cases,
additional
pesticide
loading
to
the
reservoir.
This
may
cause
either
an
increase
or
decrease
in
the
pesticide
concentration
in
the
reservoir.
Tile
drainage
also
causes
the
surface
soil
to
dry
out
faster.
This
will
reduce
runoff
of
the
pesticide
into
the
reservoir.
The
watershed
used
as
the
model
for
the
index
reservoir
(
Shipman
City
Lake)
does
not
have
tile
drainage
in
the
cropped
areas.
EXAMS
is
unable
to
easily
model
spring
and
fall
turnover.
Turnover
occurs
when
the
temperature
drops
in
the
fall
and
the
thermal
stratification
of
the
reservoir
is
removed.
Turnover
occurs
again
in
the
spring
when
the
reservoir
warms
up.
This
results
in
complete
mixing
of
the
chemical
through
the
water
column
at
these
times.
Because
of
this
inability,
the
Index
Reservoir
has
been
simulated
without
stratification.
There
is
data
to
suggest
that
Shipman
City
Lake,
upon
which
the
Index
Reservoir
is
based,
does
indeed
stratify
in
the
deepest
parts
of
the
lake
at
least
in
some
years.
This
may
result
in
both
over
and
underestimation
of
the
concentration
in
drinking
water
depending
upon
the
time
of
the
year
and
the
depth
the
drinking
water
intake
is
drawing
from.
Percent
Crop
Area
Correction
Factor
The
PCA
is
a
watershed
based
modification.
Implicit
in
its
application
is
the
assumption
that
currently
used
field
scale
models
reflect
basin
scale
processes
consistently
for
all
pesticides
and
uses.
In
other
words,
we
assume
that
the
large
field
simulated
by
the
coupled
PRZM
and
EXAMS
models
is
a
reasonable
approximation
of
pesticide
fate
and
transport
within
a
watershed
that
contains
a
drinking
water
reservoir.
If
the
13
models
fail
to
capture
pertinent
basin
scale
fate
and
transport
processes
consistently
for
all
pesticides
and
all
uses,
the
application
of
a
factor
that
reduces
the
estimated
concentrations
predicted
by
modeling
could,
in
some
instances,
result
in
inadvertently
passing
a
chemical
through
the
screen
that
may
actually
pose
a
risk.
Some
preliminary
assessments
made
in
the
development
of
the
PCA
suggest
that
PRZM/
EXAMS
may
not
be
realistically
capturing
basin
scale
processes
for
all
pesticides
or
for
all
uses.
A
preliminary
survey
of
water
assessments
which
compared
screening
model
estimates
to
readily
available
monitoring
data
suggest
uneven
model
results.
In
some
instances,
the
screening
model
estimates
are
more
than
an
order
of
magnitude
greater
than
the
highest
concentrations
reported
in
available
monitoring
data;
in
other
instances,
the
model
estimates
are
less
than
monitoring
concentrations.
Because
of
these
concerns,
the
SAP
recommended
using
the
PCA
only
for
"
major"
crops
in
the
Midwest.
For
other
crops,
development
of
PCA's
will
depend
on
the
availability
of
relevant
monitoring
data
that
could
be
used
to
evaluate
the
result
of
the
PCA
adjustment.
The
spatial
data
used
for
the
PCA
came
from
readily
available
sources
and
have
a
number
of
inherent
limitations:
°
The
size
of
the
8
digit
HUC
[
mean
=
366,989
ha;
range
=
6.7
2,282,081
ha;
n
=
2,111]
may
not
provide
reasonable
estimates
of
actual
PCA's
for
smaller
watersheds.
The
watersheds
that
drain
into
drinking
water
reservoirs
are
generally
smaller
than
the
8
digit
HUC
and
may
be
better
represented
by
watersheds
defined
for
drinking
water
intakes.
°
The
conversion
of
the
county
level
data
to
watershed
based
percent
crop
areas
assumes
the
distribution
of
the
crops
within
a
county
is
uniform
and
homogeneous
throughout
the
county
area.
Distance
between
the
treated
fields
and
the
water
body
is
not
addressed.
°
The
PCA's
were
generated
using
data
from
the
1992
Census
of
Agriculture.
However,
recent
changes
in
the
agriculture
sector
from
farm
bill
legislation
may
significantly
impact
the
distribution
of
crops
throughout
the
country.
The
methods
described
in
this
report
can
rapidly
be
updated
as
more
current
agricultural
crops
data
are
obtained.
The
assumption
that
yearly
changes
in
cropping
patterns
will
cause
minimal
impact
needs
to
be
evaluated.
14
The
PCA
adjustment
is
only
applicable
to
pesticides
applied
to
agricultural
crops.
Contributions
to
surface
waters
from
nonagricultural
uses
such
as
urban
environments
are
not
wellmodeled
Currently,
non
agricultural
uses
are
not
included
in
the
screening
model
assessments
for
drinking
water.
The
PCA
does
not
consider
percent
crop
treated
because
detailed
pesticide
usage
data
are
extremely
limited
at
this
time.
Detailed
pesticide
usage
data
are
currently
available
for
only
a
few
states.
Groundwater
Monitoring
EFED
has
limited
targeted
monitoring
data
on
the
concentrations
of
diuron
and
its
degradates
in
groundwater.
Table
7
shows
validated
monitoring
data
for
diuron
that
are
available
for
the
states
of
California
(
CA),
Florida
(
FL),
Georgia
(
GA),
and
Texas
(
TX).
Table
7.
Groundwater
monitoring
data
for
diuron.
Number
of
wells
sampled
(
number
of
wells
with
residues)
11.
State
number
of
well
range
of
conc.
(
ppb)
15
CA
2010
(
82)
0.05
3.95
FL
15385
(
9)
1.18
5.37
GA
70
(
67)
1.00
5.00
TX
31
(
2)
0.01
0.02
According
to
the
Ground
Water
Protection
Section
of
the
Florida
Department
of
Environmental
Protection12,
ground
water
samples
from
wells
collected
between
May/
1990
and
November/
1997,
showed
diuron
detections
ranging
from
0.94
12
ppb
(
detection
limit
=
0.48
ppb).
The
arithmetic
mean
concentration
was
2.44
ppb.
Well
water
samples
were
collected
from
the
following
counties:
Highlands,
Jackson,
Lake,
Orange,
and
Polk.
With
the
exception
of
the
12
ppb
sample
in
Orange
County,
the
majority
of
the
detections
were
in
Highlands
County
where
citrus
is
grown.
Diuron
concentrations
in
Highlands
County
decreased
with
time
to
about
1
ppb
but
were
detected
every
year.
In
Polk
County,
diuron
concentrations
show
a
seasonal
pattern,
with
highest
concentrations
in
the
spring
and
lowest
concentrations
in
the
fall,
but
was
not
detected
in
all
years.
The
US
Geological
Survey
(
USGS)
National
Water
Quality
Assessment
Program
(
NAWQA)
13
analyzed
pesticide
occurrence
and
concentrations
for
major
aquifers
and
shallow
ground
water
in
agricultural
areas
(
detection
limit
=
0.05
ppb).
Analysis
of
2608
samples
(
major
aquifers
study)
showed
diuron
in
71%
of
the
samples
analyzed
with
a
maximum
concentration
of
0.34
ppb.
Maximum
diuron
concentration
in
897
samples
from
shallow
groundwater
sites
was
2.0
ppb,
with
diuron
detected
in
only
1.23%
of
samples
analyzed
(
USGS,
1998).
A
major
component
of
the
sampling
design
in
the
NAWQA
study
was
to
target
specific
watersheds
and
shallow
ground
water
areas
that
are
influenced
primarily
by
a
single
dominant
land
use(
agricultural
or
urban)
that
is
important
in
the
particular
area.
The
ground
water
data
were
primarily
collected
from
a
combination
of
production
and
monitoring
wells.
Ground
water
sampling
sites
were
sampled
for
pesticides
from
a
single
snap
shot
in
time.
Even
though,
the
groundwater
monitoring
data
collected
by
NAWQA
are
from
sites
considered
typical
for
use
areas,
the
frequency
of
sampling
and
the
length
of
sampling
period
were
not
sufficient
to
represent
the
temporal
and
spatial
requirements
for
regulatory
purposes.
16
Major
component
of
the
sampling
design
in
the
NAWQA
study
was
to
target
specific
watersheds
and
shallow
ground
water
areas
that
are
influenced
primarily
by
a
single
dominant
land
use(
agricultural
or
urban)
that
is
important
in
the
particular
area.
The
ground
water
data
were
primarily
collected
from
a
combination
of
production
and
monitoring
wells.
Ground
water
sites
in
the
ground
water
data
were
sampled
for
pesticides
from
a
single
snap
shot
in
time.
Modeling
The
SCI
GROW
model
was
used
to
estimate
potential
groundwater
concentrations
for
diuron
and
its
degradates.
Tables
8,
and
9
show
input
parameters
and
output
for
SCI
GROW
modeling
of
diuron
and
its
degradates,
respectively.
Table
8.
Input
parameters
for
diuron
and
its
degradates
used
in
the
SCI
GROW
model.
compound
appl.
rate
(
lb
ai/
acre)
No.
of
appl.
/
year
Aerobic
soil
t1/
2
(
d)
Koc
(
mL/
g)
Source/
Quality
of
data
Diuron
9.6
1
372
468
label
(
EPA
Reg.
No.
1812
362);
MRID#
44490501;
MRID#
41719303;
Input
parameters
guideline
(
Aug.
2000).
Good
data.
DCPMU
2.03*
1
770
468
label
(
EPA
Reg.
No.
1812
362);
MRID#
44490501;
MRID#
;
Input
parameters
guideline
(
Aug.
2000).
Good
data.
DCPU
0.08*
1
770
468
label
(
EPA
Reg.
No.
1812
362);
MRID#
44490501;
MRID#
41719303;
Input
parameters
guideline
(
Aug.
2000).
Good
data.
3,4
DCA
0.0021*
1
30
468
label
(
EPA
Reg.
No.
1812
362);
MRID#
44490501;
MRID#
41719303;
MRID#
41538701;
Input
parameters
guideline
(
Aug.
2000).
Good
data.
17
mCPDMU
2.04*
1
372
468
label
(
EPA
Reg.
No.
1812
362);
MRID#
44490501;
MRID#
41719303;
MRID#
42260501;
Input
parameters
guideline
(
Aug.
2000).
Good
data.
*:
An
equivalent
value
based
on
conversion
of
diuron
to
degradates.
Table
9.
SCI
GROW
estimated
environmental
concentrations
for
diuron
and
its
degradates
in
groundwater.
Toxicity
end
point
model
EECs
(
F
g/
L)
use(
s)
modeled
Diuron
DCPMU
DCPU
3,4
DCA
mCPDMU
one
application
of
diuron
on
citrus
@
9.6
lb
ai/
acre
acute
6.5
2.50
0.09
0.0002
1.38
Chronic
(
non
cancer)
6.5
2.50
0.09
0.0002
1.38
Chronic
(
cancer)
6.5
2.50
0.09
0.0002
1.38
The
SCI
GROW
screening
model
developed
by
EFED
indicates
that
diuron
and
its
degradates
concentrations
are
much
less
than
those
estimated
for
surface
water.
SCI
GROW
estimated
concentrations
of
diuron
do
fall
within
the
values
from
monitoring
data
shown
in
Table
8,
but
below
some
of
the
reported
monitoring
data.
This
means
that
SCI
GROW
could
underestimate
chemical
concentrations
in
typical
use
areas
when
the
pesticide
is
used
at
the
maximum
allowed
label
rate
in
areas
with
ground
water
exceptionally
vulnerable
to
contamination
such
as
Florida.
Limitations
of
the
SCI
GROW2
Analysis
The
SCI
GROW
model
(
Screening
Concentrations
in
Ground
Water)
is
a
model
for
estimating
concentrations
of
pesticides
in
ground
water
under
"
maximum
loading"
conditions.
SCI
GROW
provides
a
screening
concentration,
an
estimate
of
likely
ground
water
concentrations
if
the
pesticide
is
used
at
the
maximum
allowed
label
rate
in
areas
with
ground
water
that
is
vulnerable
to
contamination.
In
most
cases,
a
majority
of
the
use
area
will
have
ground
water
that
is
less
vulnerable
to
contamination
than
the
areas
used
to
derive
the
SCI
GROW
estimate.
18
References:
4.
Carsel,
R.
F.,
J.
C.
Imhoff,
P.
R.
Hummel,
J.
M.
Cheplick
and
J.
S.
Donigian,
Jr.
1997.
PRZM
3,
A
Model
for
Predicting
Pesticide
and
Nitrogen
Fate
in
Crop
Root
and
Unsaturated
Soil
Zones:
Users
Manual
for
Release
3.0;
Environmental
Research
Laboratory,
Office
of
Research
and
Development,
U.
S.
Environmental
Protection
Agency,
Athens,
GA.
2.
Burns,
L.
A.
March
1997.
Exposure
Analysis
Modeling
System
(
EXAMSII)
Users
Guide
for
Version
2.97.5,
Environmental
Research
Laboratory,
Office
of
Research
and
Development,
U.
S.
Environmental
Protection
Agency,
Athens,
GA.
3.
Barrett,
M.,
1997,
Proposal
For
a
Method
to
Determine
Screening
Concentration
Estimates
for
Drinking
Water
Derived
from
Groundwater
Studies,
EFED/
OPP.
4.
USGS.
1992.
National
Water
Quality
Assessment
(
NWQA),
Pesticides
National
Synthesis
Project,
Annual
Use:
Diuron.
5.
Thurman,
E.
M.,
K.
C.
Bastian,
and
T.
Mollhagen.
Occurrence
of
cotton
herbicides
and
insecticides
in
Playa
lakes
of
the
high
plains
of
western
Texas.
[
Online].
Available
at
http://
toxics.
usgs.
gov/
pubs/
wri99
4018/
Volume2/
sectionC/
2
403Thurman/
pdf/
2403_
Thurman.
pdf,
May,
2001).
6.
U.
S
GS.
1998.
National
Water
Quality
Assessment
(
NWQA),
Pesticides
National
Synthesis
Project
[
Online]
at
(
http://
ca.
water.
usgs.
gov/
pnsp/
streamsum/
streamT1.
html).
7.
Effland,
W.,
N.
Thurman,
I.
Kennedy,
R.
D.
Jones,
J.
Breithaupt,
J.
Lin,
J.
Carleton,
L.
Libel.
R.
Parker,
and
R.
Matzner.
2000.
"
Guidance
for
use
of
the
index
Reservoir
and
Percent
Crop
Area
Factor
in
drinking
water
exposure
assessment
s.
Office
of
Pesticide
Programs.
8.
Guidance
for
Chemistry
and
Management
Practice
Input
Parameters
For
Use
in
Modeling
the
Environmental
Fate
and
Transport
of
Pesticides.
Version
2.
November
7,
2000.
U.
S.
EPA
Office
of
Pesticide
Programs,
Environmental
Fate
and
Effects
Division.
9.
The
Merck
Index.
1989.
An
encyclopedia
of
chemicals,
drugs,
and
biologicals.
11th
ed.
Rahway,
N.
J.
p.
533.
19
10.
Jones,
R.
D.,
S.
W.
Abel,
W.
Effland,
R.
Matzner,
and
R.
Parker.
1998.
"
An
Index
Reservoir
for
Use
in
Assessing
Drinking
Water
Exposures.
Chapter
IV
in
Proposed
Methods
for
Basin
Scale
Estimation
of
Pesticide
Concentrations
in
Flowing
Water
and
Reservoirs
for
Tolerance
Reassessment.,
presented
to
the
FIFRA
Science
Advisory
Panel,
July
1998.
http://
www.
epa.
gov/
pesticides/
SAP/
1998/
index.
htm.
11.
U.
S.
EPA.
1992.
Pesticides
in
Ground
Water
Database
A
compilation
of
Monitoring
Studies:
1971
1991.
Office
of
Prevention,
Pesticides,
and
Toxic
Substances,
EPA
734
12
92
001.
12.
Florida
Department
of
Environmental
Protection.
2001.
Personal
communication
with
Bryan
Baker
@
the
Groundwater
Protection
Section
(
850/
921
9435).
13.
USGS.
1998.
National
Water
Quality
Assessment
(
NWQA),
Pesticides
National
Synthesis
Project,
[
Online]
at
http://
ca.
water.
usgs.
gov/
pnsp/
allsum/#
over.
APPENDIX
I
IR
PCA
PRZM/
EXAMS
INPUT
AND
OUT
PUT
FILES
FOR
MODELING
DIURON
AND
ITS
DEGRADATES
DIURON
Metfile:
met156a.
met
PRZM
scenario:
FLcitrusC.
txt
20
EXAMS
environment
file:
IRPRZM0.
EXV
Chemical
Name:
diuron
Description
Variable
Name
Value
Units
Comments
Molecular
weight
mwt
233.1
g/
mol
Henry's
Law
Const.
henry
2.2e
10
atm
m^
3/
mol
Vapor
Pressure
vapr
2e
7
torr
Solubility
sol
420
mg/
L
Kd
Kd
16.6
mg/
L
Koc
Koc
mg/
L
Photolysis
half
life
kdp
43
days
Half
life
Aerobic
Aquatic
Metabolism
kbacw
99
days
Halfife
Anaerobic
Aquatic
Metabolism
kbacs
15
days
Halfife
Aerobic
Soil
Metabolism
asm
1116
days
Halfife
Hydrolysis:
pH
7
0
days
Half
life
Method:
CAM
2
integer
See
PRZM
manual
Incorporation
Depth:
DEPI
0.1
cm
Application
Rate:
TAPP
10.76
kg/
ha
Application
Efficiency:
APPEFF
0.99
fraction
Spray
Drift
DRFT
0.064
fraction
of
application
rate
applied
to
pond
Application
Date
Date
1
Jul
dd/
mm
or
dd/
mmm
or
dd
mm
or
dd
mmm
Record
17:
FILTRA
IPSCND
1
UPTKF
Record
18:
PLVKRT
PLDKRT
FEXTRC
0.5
Flag
for
Index
Res.
Run
IR
IR
Flag
for
runoff
calc.
RUNOFF
total
none
or
total(
average
of
entire
run)
OUTPUT
FILE
stored
as
diuron.
out
Chemical:
diuron
PRZM
environment:
FLcitrusC.
txt
EXAMS
environment:
IRPRZM0.
EXV
Metfile:
met156a.
met
Water
segment
concentrations
(
ppb)
Year
Peak
96
hr
21
Day
60
Day
90
Day
Yearly
1948
458
439
399
333
289
123
21
1949
244
234
219
196
179
67.97
1950
325
311
281
260
237
100
1951
547
526
458
348
287
107
1952
912
873
735
540
448
187
1953
412
395
342
318
297
122
1954
528
506
472
352
316
117
1955
298
286
245
204
186
80.43
1956
373
358
318
255
215
78.67
1957
728
702
596
548
495
178
1958
249
242
219
187
182
74.4
1959
364
349
307
298
285
111
1960
721
691
641
512
422
148
1961
179
172
143
123
110
52.43
1962
315
302
270
223
194
82.85
1963
438
419
371
280
226
84.78
1964
698
669
561
433
385
146
1965
397
380
333
308
271
122
1966
248
238
205
172
154
73.71
1967
428
415
360
324
302
126
1968
328
315
286
227
213
91.01
1969
407
389
357
297
265
106
1970
284
271
232
166
135
55.88
1971
246
240
213
171
161
72.11
1972
372
360
318
277
249
89.16
1973
329
317
281
226
196
81.47
1974
321
308
265
207
175
64.67
1975
255
244
205
176
156
67.02
1976
421
408
351
274
244
101
1977
276
264
222
208
198
83.01
1978
80.59
78.02
71.26
63.29
53.82
29.89
1979
360
344
297
251
240
107
1980
407
394
359
329
292
113
1981
627
602
523
468
395
135
1982
159
154
140
116
99.89
51.04
1983
515
500
432
328
272
95.07
Sorted
results
Prob.
Peak
96
hr
21
Day
60
Day
90
Day
Yearly
0.02702
7
912
873
735
548
495
187
0.05405
4
728
702
641
540
448
178
0.08108
1
721
691
596
512
422
148
0.10810
8
698
669
561
468
395
146
0.13513
5
627
602
523
433
385
135
0.16216
2
547
526
472
352
316
126
22
0.18918
9
528
506
458
348
302
123
0.21621
6
515
500
432
333
297
122
0.24324
3
458
439
399
329
292
122
0.27027
438
419
371
328
289
117
0.29729
7
428
415
360
324
287
113
0.32432
4
421
408
359
318
285
111
0.35135
1
412
395
357
308
272
107
0.37837
8
407
394
351
298
271
107
0.40540
5
407
389
342
297
265
106
0.43243
2
397
380
333
280
249
101
0.45945
9
373
360
318
277
244
100
0.48648
6
372
358
318
274
240
95.07
0.51351
4
364
349
307
260
237
91.01
0.54054
1
360
344
297
255
226
89.16
0.56756
8
329
317
286
251
215
84.78
0.59459
5
328
315
281
227
213
83.01
0.62162
2
325
311
281
226
198
82.85
0.64864
9
321
308
270
223
196
81.47
0.67567
6
315
302
265
208
194
80.43
0.70270
3
298
286
245
207
186
78.67
0.72973
284
271
232
204
182
74.4
0.75675
7
276
264
222
196
179
73.71
0.78378
4
255
244
219
187
175
72.11
0.81081
1
249
242
219
176
161
67.97
0.83783
8
248
240
213
172
156
67.02
0.86486
5
246
238
205
171
154
64.67
0.89189
244
234
205
166
135
55.88
23
2
0.91891
9
179
172
143
123
110
52.43
0.94594
6
159
154
140
116
99.89
51.04
0.97297
3
80.59
78.02
71.26
63.29
53.82
29.89
0.1
704.9
675.6
571.5
481.2
403.1
146.6
Average
of
yearly
average
s:
97.9047
2
Inputs
generaged
by
pe3.
pl
of
6
March
2002
DCPMU
Metfile:
met156a.
met
PRZM
scenario:
FLcitrusC.
txt
EXAMS
environment
file:
IRPRZM0.
EXV
Chemical
Name:
dcpmu
Description
Variable
Name
Value
Units
Comments
Molecular
weight
mwt
219.1
g/
mol
Henry's
Law
Const.
henry
2.2e
10
atm
m^
3/
mol
Vapor
Pressure
vapr
2e
7
torr
Solubility
sol
420
mg/
L
Kd
Kd
16.6
mg/
L
Koc
Koc
mg/
L
Photolysis
half
life
kdp
43
days
Half
life
Aerobic
Aquatic
Metabolism
kbacw
99
days
Halfife
Anaerobic
Aquatic
Metabolism
kbacs
15
days
Halfife
Aerobic
Soil
Metabolism
asm
2310
days
Halfife
Hydrolysis:
pH
7
0
days
Half
life
Method:
CAM
2
integer
See
PRZM
manual
Incorporation
Depth:
DEPI
0.1
cm
Application
Rate:
TAPP
2.27
kg/
ha
Application
Efficiency:
APPEFF
1.0
fraction
Spray
Drift
DRFT
fraction
of
application
rate
applied
to
pond
Application
Date
Date
1
Jul
dd/
mm
or
dd/
mmm
or
dd
mm
or
dd
mmm
Record
17:
FILTRA
IPSCND
1
UPTKF
24
Record
18:
PLVKRT
PLDKRT
FEXTRC
0.5
Flag
for
Index
Res.
Run
IR
IR
Flag
for
runoff
calc.
RUNOFF
total
none
or
total(
average
of
entire
run)
OUTPUT
FILE
stored
as
dcpmu.
out
Chemical:
dcpmu
PRZM
environment:
FLcitrusC.
txt
EXAMS
environment:
IRPRZM0.
EXV
Metfile:
met156a.
met
Water
segment
concentrations
(
ppb)
Year
Peak
96
hr
21
Day
60
Day
90
Day
Yearly
1948
98.66
94.47
86.14
71.43
62.07
25.85
1949
52.57
50.36
47.23
41.74
38.15
14.1
1950
65.48
62.73
56.33
53.1
48.39
20.87
1951
112
108
94.2
71.78
59.43
22.21
1952
190
182
153
113
93.65
39.57
1953
86.07
82.4
71.37
67.13
62.65
25.77
1954
109
104
97.29
72.81
65.75
24.6
1955
61.27
58.75
50.38
42.24
38.76
16.73
1956
79.68
76.47
68.08
54.8
45.89
16.47
1957
151
146
124
115
104
37.61
1958
47.89
46.62
42.55
37.05
36.71
15.3
1959
77.23
74.06
64.7
61.96
59.14
23.24
1960
156
150
138
111
91.33
31.36
1961
37.01
35.41
29.57
25.48
23.04
10.73
1962
66.38
63.52
56.79
47.19
40.25
17.36
1963
94.8
90.73
80.33
60.6
48.85
17.88
1964
150
143
120
93.04
83.1
31.06
1965
84.8
81.22
71.32
66.26
58.58
25.91
1966
50.82
48.7
41.83
34.92
31.53
15.2
1967
89.44
86.86
75.16
67.12
63.03
26.42
1968
68.38
65.51
59.28
47.49
44.72
18.93
1969
84.68
80.99
74.32
60.54
54.31
22.22
1970
60.77
58.12
49.66
35.48
28.64
11.44
1971
52.31
50.95
45.14
35.63
32.93
15.03
1972
75.94
73.54
65.2
57.42
51.97
18.52
1973
69.77
67.2
59.36
47.76
40.62
16.85
1974
67.55
64.68
55.56
43.6
36.69
13.28
1975
49.32
47.27
39.71
34.91
31.21
13.79
25
1976
88.99
86.16
74.33
58.16
50.53
21.14
1977
58.23
55.76
46.95
42.43
40.52
17.26
1978
17.29
16.59
15.17
13.58
11.52
5.866
1979
74.95
71.73
61.05
52.07
50.36
22.71
1980
85.67
82.81
75.83
68.59
61.02
23.67
1981
134
128
112
100
84.85
28.61
1982
34.17
32.94
29.9
25.07
21.51
10.49
1983
108
105
90.37
68.84
57.3
19.84
Sorted
results
Prob.
Peak
96
hr
21
Day
60
Day
90
Day
Yearly
0.02702
7
190
182
153
115
104
39.57
0.05405
4
156
150
138
113
93.65
37.61
0.08108
1
151
146
124
111
91.33
31.36
0.10810
8
150
143
120
100
84.85
31.06
0.13513
5
134
128
112
93.04
83.1
28.61
0.16216
2
112
108
97.29
72.81
65.75
26.42
0.18918
9
109
105
94.2
71.78
63.03
25.91
0.21621
6
108
104
90.37
71.43
62.65
25.85
0.24324
3
98.66
94.47
86.14
68.84
62.07
25.77
0.27027
94.8
90.73
80.33
68.59
61.02
24.6
0.29729
7
89.44
86.86
75.83
67.13
59.43
23.67
0.32432
4
88.99
86.16
75.16
67.12
59.14
23.24
0.35135
1
86.07
82.81
74.33
66.26
58.58
22.71
0.37837
8
85.67
82.4
74.32
61.96
57.3
22.22
0.40540
5
84.8
81.22
71.37
60.6
54.31
22.21
0.43243
2
84.68
80.99
71.32
60.54
51.97
21.14
0.45945
9
79.68
76.47
68.08
58.16
50.53
20.87
0.48648
6
77.23
74.06
65.2
57.42
50.36
19.84
0.51351
4
75.94
73.54
64.7
54.8
48.85
18.93
0.54054
1
74.95
71.73
61.05
53.1
48.39
18.52
0.56756
69.77
67.2
59.36
52.07
45.89
17.88
26
8
0.59459
5
68.38
65.51
59.28
47.76
44.72
17.36
0.62162
2
67.55
64.68
56.79
47.49
40.62
17.26
0.64864
9
66.38
63.52
56.33
47.19
40.52
16.85
0.67567
6
65.48
62.73
55.56
43.6
40.25
16.73
0.70270
3
61.27
58.75
50.38
42.43
38.76
16.47
0.72973
60.77
58.12
49.66
42.24
38.15
15.3
0.75675
7
58.23
55.76
47.23
41.74
36.71
15.2
0.78378
4
52.57
50.95
46.95
37.05
36.69
15.03
0.81081
1
52.31
50.36
45.14
35.63
32.93
14.1
0.83783
8
50.82
48.7
42.55
35.48
31.53
13.79
0.86486
5
49.32
47.27
41.83
34.92
31.21
13.28
0.89189
2
47.89
46.62
39.71
34.91
28.64
11.44
0.91891
9
37.01
35.41
29.9
25.48
23.04
10.73
0.94594
6
34.17
32.94
29.57
25.07
21.51
10.49
0.97297
3
17.29
16.59
15.17
13.58
11.52
5.866
0.1
150.3
143.9
121.2
103.3
86.794
31.15
Average
of
yearly
average
s:
20.4968
3
Inputs
generaged
by
pe3.
pl
of
6
March
2002
DCPU
Metfile:
met156a.
met
PRZM
scenario:
FLcitrusC.
txt
EXAMS
environment
file:
IRPRZM0.
EXV
Chemical
Name:
dcpu
Description
Variable
Name
Value
Units
Comments
Molecular
weight
mwt
205.1
g/
mol
Henry's
Law
Const.
henry
2.2e
10
atm
m^
3/
mol
27
Vapor
Pressure
vapr
2e
7
torr
Solubility
sol
420
mg/
L
Kd
Kd
16.6
mg/
L
Koc
Koc
mg/
L
Photolysis
half
life
kdp
43
days
Half
life
Aerobic
Aquatic
Metabolism
kbacw
99
days
Halfife
Anaerobic
Aquatic
Metabolism
kbacs
15
days
Halfife
Aerobic
Soil
Metabolism
asm
2310
days
Halfife
Hydrolysis:
pH
7
0
days
Half
life
Method:
CAM
2
integer
See
PRZM
manual
Incorporation
Depth:
DEPI
0.1
cm
Application
Rate:
TAPP
0.1
kg/
ha
Application
Efficiency:
APPEFF
0.99
fraction
Spray
Drift
DRFT
0.064
fraction
of
application
rate
applied
to
pond
Application
Date
Date
1
Jul
dd/
mm
or
dd/
mmm
or
dd
mm
or
dd
mmm
Record
17:
FILTRA
IPSCND
1
UPTKF
Record
18:
PLVKRT
PLDKRT
FEXTRC
0.5
Flag
for
Index
Res.
Run
IR
IR
Flag
for
runoff
calc.
RUNOFF
total
none
or
total(
average
of
entire
run)
OUTPUT
FILE
stored
as
dcpu.
out
Chemical:
dcpu
PRZM
environment:
FLcitrusC.
txt
EXAMS
environment:
IRPRZM0.
EXV
Metfile:
met156a.
met
Water
segment
concentrations
(
ppb)
Year
Peak
96
hr
21
Day
60
Day
90
Day
Yearly
1948
4.341
4.156
3.788
3.152
2.737
1.159
1949
2.323
2.225
2.086
1.859
1.696
0.6452
1950
3.028
2.901
2.615
2.426
2.211
0.9436
1951
5.097
4.896
4.27
3.244
2.681
1.001
1952
8.496
8.137
6.848
5.031
4.181
1.757
1953
3.864
3.7
3.201
2.989
2.797
1.155
1954
4.917
4.712
4.398
3.283
2.952
1.103
1955
2.802
2.686
2.304
1.917
1.749
0.7618
28
1956
3.531
3.389
3.014
2.421
2.036
0.7488
1957
6.785
6.544
5.558
5.115
4.627
1.672
1958
2.314
2.252
2.039
1.744
1.701
0.6986
1959
3.428
3.287
2.879
2.786
2.672
1.045
1960
6.844
6.562
6.078
4.858
4.006
1.398
1961
1.691
1.618
1.351
1.158
1.041
0.4973
1962
2.978
2.85
2.554
2.112
1.837
0.7889
1963
4.169
3.99
3.535
2.664
2.148
0.8094
1964
6.601
6.319
5.301
4.094
3.653
1.385
1965
3.751
3.593
3.153
2.919
2.579
1.162
1966
2.325
2.228
1.919
1.609
1.443
0.6956
1967
4.002
3.888
3.369
3.025
2.826
1.184
1968
3.078
2.949
2.677
2.135
2.002
0.8574
1969
3.802
3.636
3.34
2.77
2.47
0.9989
1970
2.694
2.577
2.202
1.572
1.279
0.5299
1971
2.334
2.274
2.013
1.615
1.525
0.6873
1972
3.471
3.36
2.972
2.594
2.337
0.8386
1973
3.106
2.991
2.647
2.132
1.842
0.7682
1974
3.024
2.896
2.497
1.953
1.653
0.6105
1975
2.37
2.272
1.908
1.645
1.458
0.6315
1976
3.961
3.836
3.307
2.585
2.295
0.9525
1977
2.598
2.487
2.095
1.944
1.858
0.7839
1978
0.7702
0.7457
0.6815
0.6067
0.5158
0.2854
1979
3.38
3.235
2.787
2.357
2.264
1.022
1980
3.819
3.693
3.375
3.084
2.736
1.065
1981
5.908
5.677
4.929
4.421
3.736
1.277
1982
1.519
1.464
1.33
1.112
0.954
0.487
1983
4.822
4.683
4.045
3.074
2.555
0.895
Sorted
results
Prob.
Peak
96
hr
21
Day
60
Day
90
Day
Yearly
0.02702
7
8.496
8.137
6.848
5.115
4.627
1.757
0.05405
4
6.844
6.562
6.078
5.031
4.181
1.672
0.08108
1
6.785
6.544
5.558
4.858
4.006
1.398
0.10810
8
6.601
6.319
5.301
4.421
3.736
1.385
0.13513
5
5.908
5.677
4.929
4.094
3.653
1.277
0.16216
2
5.097
4.896
4.398
3.283
2.952
1.184
0.18918
9
4.917
4.712
4.27
3.244
2.826
1.162
0.21621
6
4.822
4.683
4.045
3.152
2.797
1.159
0.24324
3
4.341
4.156
3.788
3.084
2.737
1.155
0.27027
4.169
3.99
3.535
3.074
2.736
1.103
0.29729
4.002
3.888
3.375
3.025
2.681
1.065
29
7
0.32432
4
3.961
3.836
3.369
2.989
2.672
1.045
0.35135
1
3.864
3.7
3.34
2.919
2.579
1.022
0.37837
8
3.819
3.693
3.307
2.786
2.555
1.001
0.40540
5
3.802
3.636
3.201
2.77
2.47
0.9989
0.43243
2
3.751
3.593
3.153
2.664
2.337
0.9525
0.45945
9
3.531
3.389
3.014
2.594
2.295
0.9436
0.48648
6
3.471
3.36
2.972
2.585
2.264
0.895
0.51351
4
3.428
3.287
2.879
2.426
2.211
0.8574
0.54054
1
3.38
3.235
2.787
2.421
2.148
0.8386
0.56756
8
3.106
2.991
2.677
2.357
2.036
0.8094
0.59459
5
3.078
2.949
2.647
2.135
2.002
0.7889
0.62162
2
3.028
2.901
2.615
2.132
1.858
0.7839
0.64864
9
3.024
2.896
2.554
2.112
1.842
0.7682
0.67567
6
2.978
2.85
2.497
1.953
1.837
0.7618
0.70270
3
2.802
2.686
2.304
1.944
1.749
0.7488
0.72973
2.694
2.577
2.202
1.917
1.701
0.6986
0.75675
7
2.598
2.487
2.095
1.859
1.696
0.6956
0.78378
4
2.37
2.274
2.086
1.744
1.653
0.6873
0.81081
1
2.334
2.272
2.039
1.645
1.525
0.6452
0.83783
8
2.325
2.252
2.013
1.615
1.458
0.6315
0.86486
5
2.323
2.228
1.919
1.609
1.443
0.6105
0.89189
2
2.314
2.225
1.908
1.572
1.279
0.5299
0.91891
9
1.691
1.618
1.351
1.158
1.041
0.4973
0.94594
6
1.519
1.464
1.33
1.112
0.954
0.487
0.97297
3
0.7702
0.7457
0.6815
0.6067
0.5158
0.2854
30
0.1
6.6562
6.3865
5.3781
4.5521
3.817
1.3889
Average
of
yearly
average
s:
0.92500
8
Inputs
generaged
by
pe3.
pl
of
6
March
2002
3,4
DCA
Metfile:
met156a.
met
PRZM
scenario:
FLcitrusC.
txt
EXAMS
environment
file:
IRPRZM0.
EXV
Chemical
Name:
dca
Description
Variable
Name
Value
Units
Comments
Molecular
weight
mwt
162.1
g/
mol
Henry's
Law
Const.
henry
2.2e
10
atm
m^
3/
mol
Vapor
Pressure
vapr
2e
7
torr
Solubility
sol
420
mg/
L
Kd
Kd
16.6
mg/
L
Koc
Koc
mg/
L
Photolysis
half
life
kdp
43
days
Half
life
Aerobic
Aquatic
Metabolism
kbacw
99
days
Halfife
Anaerobic
Aquatic
Metabolism
kbacs
15
days
Halfife
Aerobic
Soil
Metabolism
asm
90
days
Halfife
Hydrolysis:
pH
7
0
days
Half
life
Method:
CAM
2
integer
See
PRZM
manual
Incorporation
Depth:
DEPI
0.1
cm
Application
Rate:
TAPP
0.002
kg/
ha
Application
Efficiency:
APPEFF
0.99
fraction
Spray
Drift
DRFT
0.064
fraction
of
application
rate
applied
to
pond
Application
Date
Date
1
Jul
dd/
mm
or
dd/
mmm
or
dd
mm
or
dd
mmm
Record
17:
FILTRA
IPSCND
1
UPTKF
Record
18:
PLVKRT
PLDKRT
FEXTRC
0.5
Flag
for
Index
Res.
Run
IR
IR
Flag
for
runoff
calc.
RUNOFF
total
none
or
total(
average
of
entire
run)
31
OUTPUT
FILE
stored
as
dca.
out
Chemical:
dca
PRZM
environment:
FLcitrusC.
txt
EXAMS
environment:
IRPRZM0.
EXV
Metfile:
met156a.
met
Water
segment
concentrations
(
ppb)
Year
Peak
96
hr
21
Day
60
Day
90
Day
Yearly
1948
0.05604
0.05366
0.04829
0.04227
0.03963
0.0168
1949
0.03089
0.02958
0.02592
0.02395
0.02129
0.00817
3
1950
0.05756
0.05515
0.04984
0.04374
0.03919
0.01502
1951
0.09672
0.0929
0.08095
0.06067
0.04932
0.017
1952
0.1644
0.1574
0.1324
0.09597
0.07833
0.02836
1953
0.06428
0.06155
0.05301
0.04696
0.04327
0.01666
1954
0.09236
0.08852
0.08241
0.06076
0.05219
0.01781
1955
0.04656
0.04464
0.03827
0.03056
0.02708
0.01081
1956
0.04566
0.04381
0.03866
0.03018
0.02559
0.00917
1
1957
0.1277
0.1231
0.1044
0.09292
0.08181
0.02749
1958
0.04567
0.04444
0.04004
0.0329
0.03033
0.0114
1959
0.057
0.05464
0.04989
0.0482
0.04557
0.01655
1960
0.08523
0.08155
0.07637
0.06018
0.04928
0.0182
1961
0.02439
0.02334
0.01953
0.01617
0.01399
0.00638
1
1962
0.0442
0.04229
0.03808
0.03048
0.02707
0.0104
1963
0.04797
0.04591
0.04079
0.03042
0.0245
0.00919
1
1964
0.09001
0.08616
0.07222
0.05433
0.04661
0.01731
1965
0.05059
0.04846
0.04221
0.03648
0.03361
0.01446
1966
0.03934
0.0377
0.03273
0.02745
0.0245
0.01027
1967
0.07425
0.07121
0.06034
0.05366
0.04746
0.0183
1968
0.05082
0.04869
0.04465
0.03509
0.03231
0.01294
1969
0.06664
0.06374
0.05879
0.0512
0.04456
0.01598
1970
0.03314
0.0317
0.02711
0.0193
0.01614
0.00688
2
1971
0.03197
0.03116
0.02745
0.02341
0.02274
0.00911
9
1972
0.06228
0.06027
0.05307
0.04418
0.03849
0.01308
1973
0.04528
0.04358
0.039
0.0319
0.02889
0.01146
1974
0.04502
0.0431
0.03754
0.02884
0.02441
0.00876
1975
0.04604
0.04412
0.03707
0.03059
0.02631
0.00974
32
1
1976
0.06054
0.05868
0.0504
0.03859
0.03733
0.01404
1977
0.04515
0.04326
0.03783
0.03344
0.03137
0.01177
1978
0.00829
9
0.00802
4
0.00722
1
0.00610
1
0.00561
1
0.00330
2
1979
0.05574
0.05335
0.04676
0.03877
0.03518
0.01331
1980
0.06207
0.06011
0.05451
0.05188
0.04513
0.01648
1981
0.08621
0.08298
0.07184
0.06153
0.05135
0.01771
1982
0.01739
0.01674
0.01527
0.01226
0.01118
0.00578
5
1983
0.08038
0.07804
0.06737
0.05031
0.04114
0.01369
Sorted
results
Prob.
Peak
96
hr
21
Day
60
Day
90
Day
Yearly
0.02702
7
0.1644
0.1574
0.1324
0.09597
0.08181
0.02836
0.05405
4
0.1277
0.1231
0.1044
0.09292
0.07833
0.02749
0.08108
1
0.09672
0.0929
0.08241
0.06153
0.05219
0.0183
0.10810
8
0.09236
0.08852
0.08095
0.06076
0.05135
0.0182
0.13513
5
0.09001
0.08616
0.07637
0.06067
0.04932
0.01781
0.16216
2
0.08621
0.08298
0.07222
0.06018
0.04928
0.01771
0.18918
9
0.08523
0.08155
0.07184
0.05433
0.04746
0.01731
0.21621
6
0.08038
0.07804
0.06737
0.05366
0.04661
0.017
0.24324
3
0.07425
0.07121
0.06034
0.05188
0.04557
0.0168
0.27027
0.06664
0.06374
0.05879
0.0512
0.04513
0.01666
0.29729
7
0.06428
0.06155
0.05451
0.05031
0.04456
0.01655
0.32432
4
0.06228
0.06027
0.05307
0.0482
0.04327
0.01648
0.35135
1
0.06207
0.06011
0.05301
0.04696
0.04114
0.01598
0.37837
8
0.06054
0.05868
0.0504
0.04418
0.03963
0.01502
0.40540
5
0.05756
0.05515
0.04989
0.04374
0.03919
0.01446
0.43243
2
0.057
0.05464
0.04984
0.04227
0.03849
0.01404
0.45945
9
0.05604
0.05366
0.04829
0.03877
0.03733
0.01369
0.48648
6
0.05574
0.05335
0.04676
0.03859
0.03518
0.01331
0.51351
4
0.05082
0.04869
0.04465
0.03648
0.03361
0.01308
33
0.54054
1
0.05059
0.04846
0.04221
0.03509
0.03231
0.01294
0.56756
8
0.04797
0.04591
0.04079
0.03344
0.03137
0.01177
0.59459
5
0.04656
0.04464
0.04004
0.0329
0.03033
0.01146
0.62162
2
0.04604
0.04444
0.039
0.0319
0.02889
0.0114
0.64864
9
0.04567
0.04412
0.03866
0.03059
0.02708
0.01081
0.67567
6
0.04566
0.04381
0.03827
0.03056
0.02707
0.0104
0.70270
3
0.04528
0.04358
0.03808
0.03048
0.02631
0.01027
0.72973
0.04515
0.04326
0.03783
0.03042
0.02559
0.00974
1
0.75675
7
0.04502
0.0431
0.03754
0.03018
0.0245
0.00919
1
0.78378
4
0.0442
0.04229
0.03707
0.02884
0.0245
0.00917
1
0.81081
1
0.03934
0.0377
0.03273
0.02745
0.02441
0.00911
9
0.83783
8
0.03314
0.0317
0.02745
0.02395
0.02274
0.00876
0.86486
5
0.03197
0.03116
0.02711
0.02341
0.02129
0.00817
3
0.89189
2
0.03089
0.02958
0.02592
0.0193
0.01614
0.00688
2
0.91891
9
0.02439
0.02334
0.01953
0.01617
0.01399
0.00638
1
0.94594
6
0.01739
0.01674
0.01527
0.01226
0.01118
0.00578
5
0.97297
3
0.00829
9
0.00802
4
0.00722
1
0.00610
1
0.00561
1
0.00330
2
0.1
0.09366
8
0.08983
4
0.08138
8
0.06099
1
0.05160
2
0.01823
Average
of
yearly
average
s:
0.01343
9
Inputs
generaged
by
pe3.
pl
of
6
March
2002
mCPDMU
Metfile:
met156a.
met
34
PRZM
scenario:
FLcitrusC.
txt
EXAMS
environment
file:
IRPRZM0.
EXV
Chemical
Name:
mcpdmu
Description
Variable
Name
Value
Units
Comments
Molecular
weight
mwt
198.1
g/
mol
Henry's
Law
Const.
henry
2.2e
10
atm
m^
3/
mol
Vapor
Pressure
vapr
2e
7
torr
Solubility
sol
420
mg/
L
Kd
Kd
16.6
mg/
L
Koc
Koc
mg/
L
Photolysis
half
life
kdp
43
days
Half
life
Aerobic
Aquatic
Metabolism
kbacw
345
days
Halfife
Anaerobic
Aquatic
Metabolism
kbacs
576
days
Halfife
Aerobic
Soil
Metabolism
asm
1116
days
Halfife
Hydrolysis:
pH
7
0
days
Half
life
Method:
CAM
2
integer
See
PRZM
manual
Incorporation
Depth:
DEPI
0.1
cm
Application
Rate:
TAPP
2.28
kg/
ha
Application
Efficiency:
APPEFF
0.99
fraction
Spray
Drift
DRFT
0.064
fraction
of
application
rate
applied
to
pond
Application
Date
Date
1
Jul
dd/
mm
or
dd/
mmm
or
dd
mm
or
dd
mmm
Record
17:
FILTRA
IPSCND
1
UPTKF
Record
18:
PLVKRT
PLDKRT
FEXTRC
0.5
Flag
for
Index
Res.
Run
IR
IR
Flag
for
runoff
calc.
RUNOFF
total
none
or
total(
average
of
entire
run)
OUTPUT
FILE
stored
as
mcpdmu.
out
Chemical:
mcpdmu
PRZM
environment:
FLcitrusC.
txt
EXAMS
environment:
IRPRZM0.
EXV
Metfile:
met156a.
met
Water
segment
concentrations
35
(
ppb)
Year
Peak
96
hr
21
Day
60
Day
90
Day
Yearly
1948
111
108
102
86.4
78.22
33.14
1949
60.91
59.06
56.51
50.06
46.86
21.22
1950
76.32
74.87
66.68
65.08
61.07
29.53
1951
119
115
105
86.71
75.3
32.04
1952
195
190
168
135
118
54.72
1953
95.67
92.78
85.24
83.11
78.36
38.7
1954
118
114
109
88.57
82.88
35.84
1955
68.74
66.69
59.68
53.15
50.29
25.27
1956
83.6
81.27
75.69
65.67
57.19
23.27
1957
162
158
141
138
127
51.74
1958
59.05
57.28
52.13
48.45
48.39
24.67
1959
92.53
89.79
81.68
76.23
72.83
32.84
1960
171
166
153
132
113
42.44
1961
42.05
40.9
36.87
32.36
30.24
18.88
1962
74.52
72.24
65.92
58.63
51.84
24.17
1963
99.64
96.57
87.58
71.68
60.47
24.47
1964
154
150
132
111
102
41.51
1965
96.46
93.56
84.25
80.25
73.51
36.7
1966
59.13
57.35
51.49
44.58
41.52
23.24
1967
102
100
90.1
81.31
78.51
36.13
1968
78.5
76.13
70.05
60.24
58.09
28.19
1969
98.14
95.15
89.14
73.68
69.28
32.32
1970
65.69
63.67
56.86
44.59
37.25
18.31
1971
61.32
60.14
55.32
45.3
42.69
21.55
1972
82.3
79.84
73.47
68.58
64.48
26.28
1973
79.14
77.09
70.54
59.86
52.46
24.44
1974
73.61
71.37
63.83
53.37
46.59
19.75
1975
55.5
53.83
47.46
43.92
40.71
20.22
1976
98.21
95.81
86.64
72.98
64.27
29.55
1977
70.17
68.07
60.24
53.74
52.06
25.53
1978
21.38
20.81
18.84
17.6
15.52
10.4
1979
85.11
82.5
72.57
64.65
63.74
30.6
1980
99.32
96.8
91.78
82.6
76.45
33.65
1981
140
136
124
118
105
39.45
1982
39.57
38.59
35.96
31.95
28.43
17.34
1983
112
110
99.33
82.58
72.24
28.12
Sorted
results
Prob.
Peak
96
hr
21
Day
60
Day
90
Day
Yearly
0.02702
7
195
190
168
138
127
54.72
0.05405
4
171
166
153
135
118
51.74
0.08108
1
162
158
141
132
113
42.44
0.10810
8
154
150
132
118
105
41.51
36
0.13513
5
140
136
124
111
102
39.45
0.16216
2
119
115
109
88.57
82.88
38.7
0.18918
9
118
114
105
86.71
78.51
36.7
0.21621
6
112
110
102
86.4
78.36
36.13
0.24324
3
111
108
99.33
83.11
78.22
35.84
0.27027
102
100
91.78
82.6
76.45
33.65
0.29729
7
99.64
96.8
90.1
82.58
75.3
33.14
0.32432
4
99.32
96.57
89.14
81.31
73.51
32.84
0.35135
1
98.21
95.81
87.58
80.25
72.83
32.32
0.37837
8
98.14
95.15
86.64
76.23
72.24
32.04
0.40540
5
96.46
93.56
85.24
73.68
69.28
30.6
0.43243
2
95.67
92.78
84.25
72.98
64.48
29.55
0.45945
9
92.53
89.79
81.68
71.68
64.27
29.53
0.48648
6
85.11
82.5
75.69
68.58
63.74
28.19
0.51351
4
83.6
81.27
73.47
65.67
61.07
28.12
0.54054
1
82.3
79.84
72.57
65.08
60.47
26.28
0.56756
8
79.14
77.09
70.54
64.65
58.09
25.53
0.59459
5
78.5
76.13
70.05
60.24
57.19
25.27
0.62162
2
76.32
74.87
66.68
59.86
52.46
24.67
0.64864
9
74.52
72.24
65.92
58.63
52.06
24.47
0.67567
6
73.61
71.37
63.83
53.74
51.84
24.44
0.70270
3
70.17
68.07
60.24
53.37
50.29
24.17
0.72973
68.74
66.69
59.68
53.15
48.39
23.27
0.75675
7
65.69
63.67
56.86
50.06
46.86
23.24
0.78378
4
61.32
60.14
56.51
48.45
46.59
21.55
0.81081
1
60.91
59.06
55.32
45.3
42.69
21.22
0.83783
59.13
57.35
52.13
44.59
41.52
20.22
37
8
0.86486
5
59.05
57.28
51.49
44.58
40.71
19.75
0.89189
2
55.5
53.83
47.46
43.92
37.25
18.88
0.91891
9
42.05
40.9
36.87
32.36
30.24
18.31
0.94594
6
39.57
38.59
35.96
31.95
28.43
17.34
0.97297
3
21.38
20.81
18.84
17.6
15.52
10.4
0.1
156.4
152.4
134.7
122.2
107.4
41.789
Average
of
yearly
average
s:
29.3394
4
Inputs
generaged
by
pe3.
pl
of
6
March
2002
APPENDIX
II
SCI
GROW
OUTPUT
FILES
FOE
MODELING
DIURON
AND
ITS
DEGRADATES
RUN
No.
1
FOR
diuron
INPUT
VALUES
APPL
(#/
AC)
APPL.
URATE
SOIL
SOIL
AEROBIC
RATE
NO.
(#/
AC/
YR)
KOC
METABOLISM
(
DAYS)
38
9.600
1
9.600
468.0
372.0
GROUND
WATER
SCREENING
CONCENTRATIONS
IN
PPB
6.521987
A=
367.000
B=
473.000
C=
2.565
D=
2.675
RILP=
3.399
F=
.
168
G=
.679
URATE=
9.600
GWSC=
6.521987
RUN
No.
1
FOR
DCPMU
INPUT
VALUES
APPL
(#/
AC)
APPL.
URATE
SOIL
SOIL
AEROBIC
RATE
NO.
(#/
AC/
YR)
KOC
METABOLISM
(
DAYS)
2.030
1
2.030
468.0
770.0
GROUND
WATER
SCREENING
CONCENTRATIONS
IN
PPB
2.497237
A=
765.000
B=
473.000
C=
2.884
D=
2.675
RILP=
3.821
F=
.090
G=
1.230
URATE=
2.030
GWSC=
2.497237
RUN
No.
2
FOR
DCPU
INPUT
VALUES
39
APPL
(#/
AC)
APPL.
URATE
SOIL
SOIL
AEROBIC
RATE
NO.
(#/
AC/
YR)
KOC
METABOLISM
(
DAYS)
.080
1
.080
468.0
770.0
GROUND
WATER
SCREENING
CONCENTRATIONS
IN
PPB
.098413
A=
765.000
B=
473.000
C=
2.884
D=
2.675
RILP=
3.821
F=
.090
G=
1.230
URATE=
.080
GWSC=
.098413
RUN
No.
3
FOR
3,4
DCA
INPUT
VALUES
APPL
(#/
AC)
APPL.
URATE
SOIL
SOIL
AEROBIC
RATE
NO.
(#/
AC/
YR)
KOC
METABOLISM
(
DAYS)
.002
1
.002
468.0
30.0
GROUND
WATER
SCREENING
CONCENTRATIONS
IN
PPB
.000155
A=
25.000
B=
473.000
C=
1.398
D=
2.675
RILP=
1.852
F=
1.111
G=
.077
URATE=
.002
GWSC=
.000155
RUN
No.
4
FOR
mCPDMU
INPUT
VALUES
40
APPL
(#/
AC)
APPL.
URATE
SOIL
SOIL
AEROBIC
RATE
NO.
(#/
AC/
YR)
KOC
METABOLISM
(
DAYS)
2.04
1
2.04
468.0
372
GROUND
WATER
SCREENING
CONCENTRATIONS
IN
PPB
1.3827
A=
110.000
B=
473.000
C=
2.041
D=
2.675
RILP=
2.705
F=
.
591
G=
.257
URATE=
1.120
GWSC=
.287307
| epa | 2024-06-07T20:31:43.547324 | regulations | {
"license": "Public Domain",
"url": "https://downloads.regulations.gov/EPA-HQ-OPP-2002-0249-0007/content.txt"
} |
EPA-HQ-OPP-2002-0249-0008 | Supporting & Related Material | "2002-10-01T04:00:00" | null | Drinking
Water
Exposure
Assessment
Associated
with
the
Use
of
Direx
4L
®
Herbicide
on
Citrus
July
12,
2002
Background
Diuron
(
3[
3,4
dichlorophenyl]
1,1
dimethylurea)
is
the
active
ingredient
in
Direx
4L
®
herbidide
(
Direx).
Griffin
L.
L.
C.,
the
registrant
for
diuron,
is
working
with
Landis
International
(
Landis)
for
product
registration
support
for
Direx.
Landis
has
asked
Waterborne
Environmental,
Inc.
(
Waterborne)
to
assist
in
characterizing
the
risk
to
drinking
water
sources
associated
with
the
use
of
Direx
4L
herbicide
on
citrus
in
Southern
Florida
Flatwoods
(
MLRA
155).
Activities
being
performed
by
Waterborne
include
the
spatial
integration
of
information
on
surface
water
sources
for
drinking
water
in
the
Southern
Florida
Flatwoods
relative
to
citrus
production
and
soil
runoff
potential.
This
information
can
be
used
to
characterize
the
relative
vulnerability
of
surface
water
supplies
to
diuron
exposure.
Citrus
Production
in
the
Southern
Florida
Flatwoods
Commercial
citrus
acreage
in
Florida
was
estimated
at
approximately
832,500
acres
in
2000
(
FL
DACS,
2002).
The
geographical
distribution
by
county
is
presented
in
Figure
1.
The
Southern
Florida
Flatwoods
(
MLRA
155)
encompasses
approximately
54,570
square
miles
in
central
Florida
(
Figure
2)
and
corresponds
roughly
to
the
geographical
boundary
of
commercial
citrus
production.
The
primary
exceptions
are
the
high
citrus
production
areas
along
the
South
Central
Florida
Ridge
(
MLRA
154)
and
the
Southern
Florida
Lowlands
(
MLRA
156B).
Counties
identified
as
having
citrus
production
in
the
Southern
Florida
Flatwoods
are
listed
in
Table
1.
The
table
includes
the
county
name,
county
FIPS
code,
total
county
area,
the
portion
of
the
county
in
MLRA
155,
and
a
comparison
of
citrus
acreage
using
three
sources
of
information.
The
sources
are
discussed
below:
·
Information
obtained
from
the
Florida
Department
of
Agriculture
and
Consumer
Services
(
FL
DACS)
reflects
county
level
estimates
last
updated
October
2000
(
FL
DACS,
2002).
This
information
is
believed
to
be
the
most
accurate
account
of
citrus
acreage
in
the
State.
·
Land
use
imagery
was
also
obtained
from
the
Florida
Department
of
Environmental
Protection
(
FL
DEP,
2002)
as
three
separate
shape
files
representing
the
three
water
management
districts
in
the
Southern
Florida
Flatwoods.
The
Southern
Florida
Water
Management
District
(
SFWMD)
and
the
Saint
Johns
River
Water
Management
District
(
SJRWMD)
data
are
from
1995,
and
the
Southwest
Florida
Water
Management
District
land
use
data
are
from
1999.
The
scale
of
the
land
use
data
is
1:
40,000,
and
the
projection
is
Albers
Equal
Area
Conic.
Counties
having
area
within
the
Southern
Florida
Flatwoods
were
selected
and
exported
to
a
separate
data
layer.
Land
uses
identified
as
citrus
groves
(
SFWMD
and
SJRWMD)
or
tree
crops
(
SWFWMD)
were
exported
to
create
a
single
citrus
only
data
layer
(
Figure
3).
This
database
provides
a
relatively
detailed
spatial
resolution
of
citrus
production.
Acreage
estimates
compare
favorably
to
the
FL
DACS
estimates
with
the
exception
of
St.
Lucie
County.
·
The
National
Resources
Inventory
(
NRI)
was
included
in
this
analysis
to
characterize
soils
used
to
produce
citrus
including
their
relative
runoff
potential.
The
NRI
is
a
national
survey
of
land
use
updated
every
five
years.
Data
presented
herein
is
from
the
1992
survey
(
USDA,
1994a).
Results
from
the
1997
have
recently
been
made
available,
but
could
not
be
readily
processed
for
this
evaluation.
Citrus
is
not
a
unique
land
use
category
in
the
NRI,
but
is
represented
within
NRI
land
use
001
("
Fruit").
Each
NRI
point
is
identified
spatially
at
the
county,
MLRA,
and
zip
code
level
and
identified
by
soil
type.
Appendix
A
contains
the
acreage
and
soil
properties
for
NRI
survey
points
surveyed
as
fruit
production
in
MLRA
155.
This
acreage
compares
less
favorably
to
the
FL
DACS
estimates,
particularly
for
DeSoto,
Indian
River,
and
Lake
counties.
Soils
Used
for
Citrus
Production
in
the
Southern
Florida
Flatwoods
The
National
Resource
Inventory
(
NRI)
was
used
to
identify
candidate
soils
that
best
represent
citrus
production
in
the
Southern
Florida
Flatwoods
(
MLRA
155).
"
Fruit"
(
land
use
code
001)
was
used
as
a
land
use
category
to
identify
candidate
corn
soils
because
citrus
is
not
a
unique
land
use
category
in
the
NRI.
Candidate
soils
were
then
ranked
by
runoff
potential
(
Appendix
A).
Soil
properties
used
to
assess
runoff
potential
were
obtained
from
the
U.
S.
Department
of
Agriculture's
soil
property
database,
SOILS5
(
USDA,
1994b).
Hydrologic
Soil
Group
(
USDA,
1972)
was
used
as
the
primary
ranking
criteria,
in
which
"
D"
soils
were
ranked
above
"
C"
soils,
etc.
Sand
content
(
low
to
high)
was
used
as
a
secondary
ranking.
Average
organic
matter
(
high
to
low),
average
slope
(
high
to
low),
and
soil
series
name
(
ascending)
were
used
for
subsequent
ranking.
Soil
series
name
was
included
as
a
final
tiebreaker
so
that
multiple
NRI
entry
points
of
the
same
series
would
be
clustered
together.
Soils
classified
as
high
runoff
potential
(
Hydrologic
Soil
Group
D)
represent
approximately
3.5
percent
of
the
fruit
production
in
the
Southern
Florida
Flatwoods.
Hydrologic
Soil
Groups
C/
D,
C,
B/
D,
and
B
represent
approximately
3.0,
9.4,
71.9,
and
0.2
percent
of
fruit
production
in
the
MLRA.
Soils
classified
as
having
low
runoff
potential
(
Hydrologic
Soil
Group
A)
represent
11.8
percent
of
fruit
acreage
in
the
MLRA
Surface
Water
Supplies
in
Florida
Very
few
public
water
supplies
rely
on
surface
water
in
the
state
of
Florida.
Ground
water
accounts
for
90
percent
of
public
supply
water
in
Florida
(
USGS,
1990).
The
locations
of
individual
drinking
water
supplies
relying
on
surface
water
in
the
Southern
Florida
Flatwoods
(
Figure
3)
were
identified
from
a
variety
of
sources,
including
the
Florida
Department
of
Environmental
Protection
(
FL
DEP,
2002);
the
U.
S.
Environmental
Protection
Agency
(
USEPA,
1990;
1999;
2002),
and
the
U.
S.
Geological
Survey
(
1990).
Sources
were
cross
referenced
in
an
attempt
to
obtain
a
comprehensive
list.
Intakes
are
identified
by
facility
name
in
Table
2
and
Figure
4.
Although
efforts
were
made
to
screen
for
surface
water
supplies,
some
facilities
are
identified
by
name
as
well
fields,
indicating
that
these
facilities
may
rely
on
combination
ground
water
and
surface
water
resources.
Based
on
a
preliminary
analysis
of
Figures
3
and
4,
surface
water
sources
with
the
highest
density
of
citrus
appear
to
be
the
Peace
River,
Shell
Creek,
and
Fordham
Waterways
in
De
Soto
and
Charlotte
Counties.
Citrus
areas
outside
of
the
Southern
Florida
Flatwoods
(
e.
g.,
in
the
South
Central
Florida
Ridge,
MLRA
154)
may
also
be
in
the
contributing
watersheds
of
these
drinking
water
supplies.
Conclusions
and
Recommendations
·
The
Southern
Florida
Flatwoods
(
MLRA
155)
comprise
much
of
the
citrus
production
in
the
State
of
Florida.
Significant
production
also
occurs
along
the
South
Central
Florida
Ridge
(
MLRA
154)
and
the
Southern
Florida
Lowlands
(
MLRA
156B).
·
Very
little
acreage
of
this
acreage
resides
on
high
runoff
potential
soils.
Hydrologic
Soil
Group
D,
C/
D,
and
C
represent
3.0,
3.0,
and
9.3
percent
of
fruit
production
in
the
MLRA.
The
majority
of
citrus
acreage
resides
on
Hydrologic
Soil
Group
B/
D.
This
soils
classification
behaves
as
a
D
soil
unless
a
suitable
drainage
exists
on
site.
Anthropogenic
alteration
of
this
land
to
facilitate
agriculture
(
ditches,
canales,
etc.)
renders
the
behavior
as
a
B
soil.
·
Ground
water
accounts
for
90
percent
of
public
supply
water
in
Florida
(
USGS,
1990).
Fifty
five
surface
water
supplies
were
identified
as
potentially
impacted
by
land
use
activities
in
the
Southern
Florida
Flatwoods
(
MLRA
155)
and
adjacent
areas
in
the
South
Central
Florida
Ridge
(
MLRA
154)
and
the
Southern
Florida
Lowlands
(
MLRA
156B).
Many
of
these
intake
locations
are
identified
as
having
the
same
facility/
source
name,
identification
number,
and/
or
similar
latitude/
longitude
indicating
either
potential
duplicate
entries
or
multiple
withdrawals
from
the
same
location.
·
Surface
water
sources
with
the
highest
density
of
citrus
in
their
upstream
watersheds
appear
to
be
the
Peace
River,
Shell
Creek,
and
Fordham
Waterways
in
De
Soto
and
Charlotte
Counties.
Citrus
areas
outside
of
the
Southern
Florida
Flatwoods
(
e.
g.,
in
the
South
Central
Florida
Ridge,
MLRA
154)
may
also
be
in
the
contributing
watersheds
of
these
drinking
water
supplies.
·
Conclusions
cannot
be
drawn
about
the
likelihood
of
diruon
residues
in
these
drinking
water
supplies
without
verifying
intake
locations
and
better
characterization
of
watershed
composition
and
diuron
use.
References
1.
Florida
Department
of
Environmental
Protection
(
FL
DEP),
2002a.
GIS
GeoData.
Land
Use
Data
by
Water
Management
District.
http://
www.
dep.
state.
fl.
us/
gis/
datadir.
asp
(
updated
May
2
2002).
2.
Florida
Department
of
Environmental
Protection
(
FLDEP),
2002b.
Drinking
Water
Basic
Facility
Reports.
http://
www.
dep.
state.
fl.
us/
water/
drinkingwater/
bfr.
htm
(
updated
May
2
2002).
3.
Florida
Department
of
Agriculture
and
Consumer
Services
(
FL
DACS),
2002.
Florida
Agricultural
Statistics:
Citrus
Summary
2000
01.
Published
January
2002.
4.
U.
S.
Department
of
Agriculture
(
USDA),
2002.
Southeast
Major
Land
Resource
Areas.
National
Resource
Conservation
Service.
http://
www.
nrcs.
usda.
gov/
technical/
land/
mlra/
mlrase.
html
(
verified
July
12,
2002).
5.
U.
S.
Department
of
Agriculture
(
USDA),
1994a.
1992
National
Resources
Inventory:
Soil
Conservation
Service.
6.
U.
S.
Department
of
Agriculture
(
USDA),
1994b.
Soil
Property
Database,
SOILS5:
Soil
Conservation
Service.
7.
U.
S.
Department
of
Agriculture
(
USDA),
1972.
National
Engineering
Handbook,
Section
4,
Hydrology:
Soil
Conservation
Service,
pp
71
72.
8.
U.
S.
Environmental
Protection
Agency
(
USDA),
2002.
Safe
Drinking
Water
Information
System
(
SDWIS),
Local
Drinking
Water
Information.
http://
www.
epa.
gov/
safewater/
dwinfo/
fl.
htm
(
updated
June
11,
2002)
9.
U.
S.
Environmental
Protection
Agency
(
USEPA),
1999.
BASINS,
Version
2.0,
January
1999.
Region
4.
U.
S.
EPA
Office
of
Water,
Office
of
Science
and
Technology.
EPA
823
C
98
006.
10.
U.
S.
Environmental
Protection
Agency
(
USEPA),
1990.
Drinking
Water
Supply
(
DWS)
File.
Automated
database
developed
by
USEPA
Office
of
Water.
TABLE
1.
Citrus
Producing
Counties
in
Southern
Florida
Flatwoods
(
MLRA
155)
MLRA/
Citrus
Estimate
by
County
Citrus
Estimate
by
MLRA
in
County
County
FIPS
County
Area
MLRA
155
County
FL
DACS
(
2002)
FL
DEP
(
2002)
NRI
(
1994a)
FL
DEP
(
2002)
NRI
(
1994a)
(
acres)
(
acres)
(%)
(
acres)
(%)
(
acres)
(%)
(
acres)
(%)
(
acres)
(%)
(
acres)
(%)
Alachua
12,001
576,940
200,500
34.8
0
0.0
97
0.0
3,500
0.6
76
0.0
3500
1.7
Brevard
12009
637,062
291,200
45.7
10,045
1.6
12,101
1.9
9,600
1.5
8,097
2.8
9,600
3.3
Charlotte
12015
441,612
431,300
97.7
21,756
4.9
27,105
6.1
20,800
4.7
27,105
6.3
20,800
4.8
Collier
12021
1,276,224
416,900
32.7
35,302
2.8
40,984
3.2
53,500
4.2
34,667
8.3
48,300
11.6
DeSoto
12027
406,867
404,000
99.3
71,781
17.6
80,495
19.8
40,400
9.9
80,495
19.9
40,400
10.0
Glades
12043
488,300
483,100
98.9
10,506
2.2
12,808
2.6
8,000
1.6
12,808
2.7
8,000
1.7
Hardee
12049
407,968
406,400
99.6
53,115
13.0
60,721
14.9
66,400
16.3
60,721
14.9
66,400
16.3
Hendry
12051
744,012
666,900
89.6
99,437
13.4
121,078
16.3
127,200
17.1
120,007
18.0
127,200
19.1
Highlands
12055
658,310
423,000
64.3
78,132
11.9
87,962
13.4
45,300
6.9
36,553
8.6
2,700
0.6
Hillsborough
12057
673,830
527,100
78.2
26,223
3.9
33,437
5.0
54,800
8.1
17,877
3.4
48,400
9.2
Indian
River
12061
318,118
112,200
35.3
60,293
19.0
81,088
25.5
98,300
30.9
27,377
24.4
20,700
18.4
Lake
12069
610,790
30,800
5.0
20,101
3.3
34,760
5.7
121,200
19.8
611
2.0
2,200
7.1
Lee
12071
513,952
496,500
96.6
11,594
2.3
14,863
2.9
14,800
2.9
14,821
3.0
14,800
3.0
Manatee
12081
478,163
469,600
98.2
23,254
4.9
27,420
5.7
21,800
4.6
27,372
5.8
21,800
4.6
Martin
12085
355,001
217,000
61.1
44,746
12.6
59,123
16.7
63,800
18.0
19,303
8.9
21,700
10.0
Okeechobee
12093
493,113
476,100
96.5
12,170
2.5
14,968
3.0
16,800
3.4
11,230
2.4
6,400
1.3
Orange
12095
582,713
421,600
72.4
8,095
1.4
24,887
4.3
21,700
3.7
4,468
1.1
5,400
1.3
Osceola
12097
863,795
843,300
97.6
15,273
1.8
22,537
2.6
30,500
3.5
19,066
2.3
27,100
3.2
Palm
Beach
12099
1,275,590
209,800
16.4
10,090
0.8
20,105
1.6
20,800
1.6
515
0.2
2,200
1.0
Pasco
12101
472,224
84,900
18.0
10,897
2.3
14,783
3.1
35,100
7.4
1,412
1.7
1,800
2.1
Polk
12105
1,166,803
614,100
52.6
101,484
8.7
128,758
11.0
139,300
11.9
15,437
2.5
44,400
7.2
Sarasota
12115
366,809
357,500
97.5
2,321
0.6
3,844
1.0
3,200
0.9
3,844
1.1
3,200
0.9
Seminole
12117
190,739
137,000
71.8
1,378
0.7
2,861
1.5
8,100
4.2
2,608
1.9
5,900
4.3
St.
Lucie
12111
371,840
239,700
64.5
98,899
26.6
133,717
36.0
94,500
25.4
14,037
5.9
32,100
13.4
Volusia
12127
712,198
664,100
93.2
1,430
0.2
4,390
0.6
1,000
0.1
4,388
0.7
1,000
0.2
FL
DACS
(
2002)
=
Commercial
citrus
acreage
updated
October
2000
FL
DEP
(
2002)
=
Land
use
dated
1999
and
1995
and
designated
as
"
citrus
grove"
or
"
tree
crop"
depending
on
Water
Management
District
NRI
(
1994a)
=
Land
use
001
(
fruit)
TABLE
2.
Surface
Water
Intakes
in
Southern
Florida
Flatwoods
(
MLRA
155)
County
Facility
Name
FRDS
DWS
BASINS
BREVARD
FL3051447
BREVARD
LAKE
WASHINGTON
FL3051447
BREVARD
MELBOURNE
FILT
PLANT
FL3051447
BREVARD
PALM
BAY,
CITY
OF
BREVARD
WEST
MELBOURNE
WATER
SYSTEM
BROWARD
FIVEASH
WATER
WORKS
FL4060487
BROWARD
P.
O.
DIXIE
WATER
WKS
FL4060487
BROWARD
PROSPECT
LK
(
EMER)
FL4060487
CHARLOTTE
FORDHAM
FILT
PLANT
FL6142734
CHARLOTTE
FORDHAM
WATERWAY
FL6142734
CHARLOTTE
MYAKKAHATCHEE
CREEK
FL6142734
CHARLOTTE
NORTHPORT
FILT
PLANT
FL6142734
CHARLOTTE
PEACE
R
FILT
PLANT
FL6142734
CHARLOTTE
PEACE
RIVER
FL6142734
CHARLOTTE
SHELL
CREEK
FL5080051
CHARLOTTE
TREATMENT
PLANT
FL5080051
COLLIER
MAN
MADE
LAKE
FL5110183
COLLIER
TREATMENT
PLANT
FL5110183
HENDRY
LAKE
OKEECHOBEE
HENDRY
TREATMENT
PLANT
HIGHLANDS
LAKE
SIRENA
FL5280286
HIGHLANDS
TREATMENT
PLANT
FL5280286
HILLSBOROUGH
FL6290327
HILLSBOROUGH
CITY
WELLS
(
3%)
FL6290327
HILLSBOROUGH
HILLSBOROUGH
RIVER
FL6290327
HILLSBOROUGH
TAMPA
FILT
PLANT
FL6290327
HILLSBOROUGH
WELL
TREATMENT
PLT
FL6290327
LEE
CALOOSAHATCHEE
RIVER
FL5360102
LEE
CALOOSAHATCHEE
RIVER
FL5360170
LEE
FT
MYERS
PUMP
STATIO
FL5360102
LEE
OLGA
FILTER
PLANT
FL5360170
MANATEE
BRADENTON
FILT
PLANT
FL6410182
MANATEE
COUNTY
FILTER
PLANT
FL6411132
MANATEE
LAKE
MANATEE
FL6411132
MANATEE
WARD
LAKE
FL6410182
OKEECHOBEE
LAKE
OKEECHOBEE
FL4470257
OKEECHOBEE
BET
HER
ACRES
OKEECHOBEE
RIVERBEND
TRAILER
PARK
OKEECHOBEE
TREATMENT
PLANT
FL4470257
PALM
BEACH
LAKE
OKEECHOBEE
FL4500105
PALM
BEACH
LAKE
OKEECHOBEE
FL4501023
PALM
BEACH
OKEECHOBEE
LAKE
FL4500258
PALM
BEACH
CLEAR
LAKE
FL4501559
PALM
BEACH
FILT
PLT
FL4500773
PALM
BEACH
INFILT
GAL
OSBURN
L.
FL4500773
PALM
BEACH
LAKE
OKEECHOBEE
FL5260297
PALM
BEACH
TREATMENT
PLANT
FL4500105
PALM
BEACH
TREATMENT
PLANT
FL4500258
PALM
BEACH
TREATMENT
PLANT
FL4501023
PALM
BEACH
TREATMENT
PLANT
FL5260297
PALM
BEACH
W
PALM
BCH
FILT
PLT
FL4501559
PINELLAS
COSME
WELL
PLANT
PINELLAS
COSME
WELLFIELD
PUTNAM
SULPHUR
SPRING
PUTNAM
TREATMENT
PLANT
FL2540862
Commercial
Citrus
Acreage
2000
Commercial
Acres
Polk
Hendry
St.
Lucie
Highlands
DeSoto
Indian
River
Hardee
Martin
Collier
Hillsborough
Manatee
Charlotte
Lake
Osceola
Okeechobee
Lee
Pasco
Glades
Palm
Beach
Brevard
Orange
Sarasota
Volusia
Seminole
Marion
Miami
Dade
Hernando
Citrus
Putnam
Broward
Pinellas
Sumter
Total
101,484
99,437
98,899
78,132
71,781
60,293
53,115
44,746
35,302
26,223
23,254
21,756
20,101
15,273
12,170
11,594
10,897
10,506
10,090
10,045
8,095
2,321
1,430
1,378
1,245
1,151
1,105
247
212
58
50
36
832,426
FIGURE
1.
Commercial
Citrus
Acreage
(
Source:
FLDACS,
2002)
FIGURE
2.
Southeast
Major
Land
Resource
Areas
(
source:
USDA,
2002)
POLK
LAKE
COLLIER
LEVY
MARION
LEE
PALM
BEACH
OSCEOLA
HENDRY
VOLUSIA
DIXIE
CLAY
GLADES
ORANGE
BROWARD
PASCO
ALACHUA
PUTNAM
HIGHLANDS
BREVARD
CITRUS
MARTIN
DADE
HARDEE
MANATEE
DE
SOTO
SUMTER
HILLSBOROUGH
OKEECHOBEEST
LUCIE
ST
JOHNS
DUVAL
FLAGLER
SARASOTA
COLUMBIA
SUWANNEE
CHARLOTTE
LAFAYETTE
BAKER
HERNANDO
UNION
INDIAN
RIVER
SEMINOLE
GILCHRIST
PINELLAS
BRADFORD
Citrus
Rivers
County
Boundary
Drinking
Water
Supply
Southern
Florida
Flatwood
0
150
300
75
Miles
Figure
3.
Surface
water
intakes
and
citrus
production
in
the
Southern
Florida
Flatwoods
POLK
LAKE
COLLIER
MARION
LEE
LEVY
PALM
BEACH
OSCEOLA
HENDRY
VOLUSIA
GLADES
ORANGE
BROWARD
PASCO
HIGHLANDS
BREVARD
CITRUS
MARTIN
HARDEE
MANATEE
DADE
DE
SOTO
PUTNAM
SUMTER
HILLSBOROUGH
OKEECHOBEE
ST
LUCIE
ALACHUA
FLAGLER
SARASOTA
CHARLOTTE
HERNANDO
INDIAN
RIVER
SEMINOLE
PINELLAS
GILCHRIST
ST
JOHNS
FILT
PLT
WARD
LAKE
CLEAR
LAKE
PEACE
RIVER
LAKE
SIRENA
SHELL
CREEK
LAKE
MANATEE
MAN
MADE
LAKE
BET
HER
ACRES
CITY
WELLS
(
3%)
TREATMENT
PLANT
TREATMENT
PLANT
TREATMENT
PLANT
TREATMENT
PLANT
TREATMENT
PLANT
LAKE
OKEECHOBEE
TREATMENT
PLANT
LAKE
OKEECHOBEE
TAMPA
FILT
PLANT
FORDHAM
WATERWAY
OLGA
FILTER
PLANT
WELL
TREATMENT
PLT
PROSPECT
LK
(
EMER)
CALOOSAHATCHEE
RIVER
FT
MYERS
PUMP
STATIO
Rivers
County
Boundary
Drinking
Water
Supply
Figure
4.
Surface
water
intakes
locations
and
names
25
0
25
12.5
Miles
APPENDIX
A.
Soils
Surveyed
for
Fruit
Production
in
the
Southern
Florida
Flatwoods
(
MLRA
155)
Glossary:
S5NAME
Soil
series
name
FIPS
Fips
code
NRIPTR
Unique
entry
identifier
in
NRI
database
HYDGRP
Hydrologic
Soil
Group
SURFTXT
Texture
of
surface
horizon
LOSLOPE
Low
value
of
field
slope
(%)
HISLOPE
High
value
of
field
slope
(%)
AVGSLOPE
Midpoint
value
of
field
slope
(%)
UKFACT
Universal
Soil
Loss
Equation
(
USLE)
Soil
Erodibility
Factor
USLE92
USLE
soil
loss
(
tons/
year)
SANDL
Low
value
of
sand
content
in
surface
horizon
(%)
SANDH
High
value
of
sand
content
in
surface
horizon
(%)
SANDAV
Midpoint
value
of
sand
content
in
surface
horizon
(%)
CLAYL
Low
value
of
clay
content
in
surface
horizon
(%)
CLAYH
High
value
of
clay
content
in
surface
horizon
(%)
BDH
High
value
of
bulk
density
in
surface
horizon
BDL
Low
value
of
bulk
density
in
surface
horizon
OML
Low
value
of
organic
matter
in
surface
horizon
(%)
OMH
High
value
of
organic
matter
in
surface
horizon
(%)
OMAV
Midpoint
value
of
organic
matter
in
surface
horizon
(%)
ACRES
Acreage
of
survey
point
(
calculated
from
NRI
field
XFACT*
100)
CUM_
AC
Cumulative
acreage
in
ranked
table
CUM_
PCT
Cumulative
percentage
of
acreage
in
ranked
table
Soils
Surveyed
for
"
Fruit"
Production
in
Southern
Florida
Flatwoods
(
MLRA
155)
Ranked
by
Runoff
Potential
NRIPTR
S5NAME
SURFTXT
FIPS
HYDGRP
LOSLOPE
HISLOPE
AVGSLOPE
UKFACT
USLE92
SANDLOW
SANDHI
SANDAV
CLAYL
CLAYH
BDL
BDH
OML
OMH
OMAV
ACRES
CUM_
AC
CUM_
PCT
215830
HILOLO
LS
12111
D
0
2
1
0.15
0.11
75
87
81
5
13
1.4
1.6
1
5
3
800
800
0.14
215830
HILOLO
LS
12111
D
0
2
1
0.15
0.11
75
87
81
5
13
1.4
1.6
1
5
3
800
1,600
0.27
215879
FLORIDANA
FS
12085
D
0
2
1
0.1
0.01
75
95
85
3
10
1.4
1.5
6
15
10.5
500
2,100
0.36
216012
BRADENTON
FS
12049
D
0
2
1
0.1
0.61
88
95
91.5
1
6
1.3
1.5
2
8
5
700
2,800
0.48
215907
RIVIERA
FS
12085
D
0
2
1
0.1
0.05
88
96
92
1
6
1.4
1.65
0.1
2
1.05
500
3,300
0.56
215907
RIVIERA
FS
12085
D
0
2
1
0.1
0.06
88
96
92
1
6
1.4
1.65
0.1
2
1.05
500
3,800
0.65
215907
RIVIERA
FS
12085
D
0
2
1
0.1
0.06
88
96
92
1
6
1.4
1.65
0.1
2
1.05
500
4,300
0.73
215907
RIVIERA
FS
12085
D
0
2
1
0.1
0.01
88
96
92
1
6
1.4
1.65
0.1
2
1.05
900
5,200
0.89
215907
RIVIERA
FS
12085
D
0
2
1
0.1
0.07
88
96
92
1
6
1.4
1.65
0.1
2
1.05
500
5,700
0.97
215907
RIVIERA
FS
12085
D
0
2
1
0.1
0.01
88
96
92
1
6
1.4
1.65
0.1
2
1.05
1,000
6,700
1.14
215907
RIVIERA
FS
12085
D
0
2
1
0.1
0.01
88
96
92
1
6
1.4
1.65
0.1
2
1.05
500
7,200
1.23
215895
BOCA
FS
12021
D
0
2
1
0.1
0.15
88
98
93
0
2
1.3
1.55
1
3
2
3,500
10,700
1.83
215882
LAWNWOOD
FS
12085
D
0
2
1
0.1
0.06
90
98
94
0
2
1.3
1.55
1
3
2
500
11,200
1.91
215891
WAVELAND
FS
12085
D
0
2
1
0.1
0.07
90
98
94
0
1
1.3
1.6
1
3
2
500
11,700
2.00
215892
WAVELAND
S
12085
D
0
2
1
0.1
0.01
90
98
94
0
1
1.3
1.6
1
3
2
900
12,600
2.15
215885
HOLOPAW
S
12051
D
0
2
1
0.1
0.02
90
98
94
1
7
1.35
1.6
1
4
2.5
3,100
15,700
2.68
215815
PEPPER
S
12061
D
0
2
1
0.1
0.07
90
98
94
0
2
1.32
1.44
1
4
2.5
400
16,100
2.75
215558
ANKONA
S
12111
D
0
2
1
0.1
0.05
90
98
94
0
4
1.2
1.5
2
4
3
100
16,200
2.76
215558
ANKONA
S
12111
D
0
2
1
0.1
0.05
90
98
94
0
4
1.2
1.5
2
4
3
1,800
18,000
3.07
215558
ANKONA
S
12111
D
0
2
1
0.1
0.05
90
98
94
0
4
1.2
1.5
2
4
3
1,800
19,800
3.38
215558
ANKONA
S
12111
D
0
2
1
0.1
0.07
90
98
94
0
4
1.2
1.5
2
4
3
800
20,600
3.52
215494
RIVIERA
FS
12085
C/
D
0
2
1
0.1
0.01
88
96
92
1
6
1.4
1.65
0.1
2
1.05
1,000
21,600
3.69
215494
RIVIERA
FS
12085
C/
D
0
2
1
0.1
0.07
88
96
92
1
6
1.4
1.65
0.1
2
1.05
500
22,100
3.77
215494
RIVIERA
FS
12111
C/
D
0
2
1
0.1
0.11
88
96
92
1
6
1.4
1.65
0.1
2
1.05
1,300
23,400
3.99
215494
RIVIERA
FS
12085
C/
D
0
2
1
0.1
0.08
88
96
92
1
6
1.4
1.65
0.1
2
1.05
500
23,900
4.08
215494
RIVIERA
FS
12061
C/
D
0
2
1
0.1
0.11
88
96
92
1
6
1.4
1.65
0.1
2
1.05
500
24,400
4.16
215494
RIVIERA
FS
12111
C/
D
0
2
1
0.1
0.07
88
96
92
1
6
1.4
1.65
0.1
2
1.05
800
25,200
4.30
215494
RIVIERA
FS
12051
C/
D
0
2
1
0.1
0.03
88
96
92
1
6
1.4
1.65
0.1
2
1.05
3,200
28,400
4.85
215494
RIVIERA
FS
12061
C/
D
0
2
1
0.1
0.31
88
96
92
1
6
1.4
1.65
0.1
2
1.05
600
29,000
4.95
215494
RIVIERA
FS
12051
C/
D
0
2
1
0.1
0.03
88
96
92
1
6
1.4
1.65
0.1
2
1.05
3,200
32,200
5.49
215494
RIVIERA
FS
12061
C/
D
0
2
1
0.1
0.13
88
96
92
1
6
1.4
1.65
0.1
2
1.05
500
32,700
5.58
215494
RIVIERA
FS
12061
C/
D
0
2
1
0.1
0.13
88
96
92
1
6
1.4
1.65
0.1
2
1.05
600
33,300
5.68
215494
RIVIERA
FS
12061
C/
D
0
2
1
0.1
0.12
88
96
92
1
6
1.4
1.65
0.1
2
1.05
500
33,800
5.77
215496
RIVIERA
S
12111
C/
D
0
2
1
0.1
0.01
88
96
92
1
6
1.4
1.65
0.1
2
1.05
1,000
34,800
5.94
215496
RIVIERA
S
12111
C/
D
0
2
1
0.1
0.02
88
96
92
1
6
1.4
1.65
0.1
2
1.05
1,000
35,800
6.11
215496
RIVIERA
S
12111
C/
D
0
2
1
0.1
0.06
88
96
92
1
6
1.4
1.65
0.1
2
1.05
800
36,600
6.25
215496
RIVIERA
S
12009
C/
D
0
2
1
0.1
0.07
88
96
92
1
6
1.4
1.65
0.1
2
1.05
1,200
37,800
6.45
215496
RIVIERA
S
12099
C/
D
0
2
1
0.1
0.58
88
96
92
1
6
1.4
1.65
0.1
2
1.05
500
38,300
6.54
215250
SPARR
S
12105
C
0
5
2.5
0.1
0.57
86
95
90.5
1
5
1.2
1.5
0.5
3
1.75
2,900
41,200
7.03
215244
SPARR
FS
12049
C
0
2
1
0.1
0.55
86
95
90.5
1
5
1.2
1.5
0.5
3
1.75
1,100
42,300
7.22
215244
SPARR
FS
12049
C
0
2
1
0.1
0.61
86
95
90.5
1
5
1.2
1.5
0.5
3
1.75
1,500
43,800
7.47
215932
ZOLFO
FS
12049
C
0
2
1
0.1
0.46
88
95
91.5
1
5
1.35
1.55
0.5
1
0.75
400
44,200
7.54
215932
ZOLFO
FS
12049
C
0
2
1
0.1
1.18
88
95
91.5
1
5
1.35
1.55
0.5
1
0.75
1,500
45,700
7.80
215932
ZOLFO
FS
12049
C
0
2
1
0.1
0.61
88
95
91.5
1
5
1.35
1.55
0.5
1
0.75
600
46,300
7.90
215932
ZOLFO
FS
12049
C
0
2
1
0.1
0.76
88
95
91.5
1
5
1.35
1.55
0.5
1
0.75
1,500
47,800
8.16
Soils
Surveyed
for
"
Fruit"
Production
in
Southern
Florida
Flatwoods
(
MLRA
155)
Ranked
by
Runoff
Potential
NRIPTR
S5NAME
SURFTXT
FIPS
HYDGRP
LOSLOPE
HISLOPE
AVGSLOPE
UKFACT
USLE92
SANDLOW
SANDHI
SANDAV
CLAYL
CLAYH
BDL
BDH
OML
OMH
OMAV
ACRES
CUM_
AC
CUM_
PCT
215932
ZOLFO
FS
12049
C
0
2
1
0.1
1.61
88
95
91.5
1
5
1.35
1.55
0.5
1
0.75
1,400
49,200
8.40
215932
ZOLFO
FS
12057
C
0
2
1
0.1
1.15
88
95
91.5
1
5
1.35
1.55
0.5
1
0.75
1,400
50,600
8.63
215932
ZOLFO
FS
12049
C
0
2
1
0.1
1.18
88
95
91.5
1
5
1.35
1.55
0.5
1
0.75
1,500
52,100
8.89
215932
ZOLFO
FS
12049
C
0
2
1
0.1
1.04
88
95
91.5
1
5
1.35
1.55
0.5
1
0.75
1,500
53,600
9.15
215932
ZOLFO
FS
12049
C
0
2
1
0.1
0.96
88
95
91.5
1
5
1.35
1.55
0.5
1
0.75
1,500
55,100
9.40
215932
ZOLFO
FS
12027
C
0
2
1
0.1
0.01
88
95
91.5
1
5
1.35
1.55
0.5
1
0.75
1,800
56,900
9.71
215932
ZOLFO
FS
12049
C
0
2
1
0.1
0.61
88
95
91.5
1
5
1.35
1.55
0.5
1
0.75
1,500
58,400
9.97
215932
ZOLFO
FS
12049
C
0
2
1
0.1
0.61
88
95
91.5
1
5
1.35
1.55
0.5
1
0.75
1,500
59,900
10.22
215932
ZOLFO
FS
12049
C
0
2
1
0.1
0.61
88
95
91.5
1
5
1.35
1.55
0.5
1
0.75
1,500
61,400
10.48
215932
ZOLFO
FS
12049
C
0
2
1
0.1
0.65
88
95
91.5
1
5
1.35
1.55
0.5
1
0.75
1,500
62,900
10.73
215350
ADAMSVILLE
FS
12049
C
0
2
1
0.1
0.01
88
95
91.5
1
8
1.35
1.65
0
2
1
1,300
64,200
10.96
215353
ADAMSVILLE
S
12097
C
0
2
1
0.1
0.51
88
95
91.5
1
8
1.35
1.65
0
2
1
3,100
67,300
11.48
215353
ADAMSVILLE
S
12097
C
0
2
1
0.1
0.51
88
95
91.5
1
8
1.35
1.65
0
2
1
100
67,400
11.50
215257
ELECTRA
S
12061
C
0
5
2.5
0.1
0.01
90
97
93.5
1
6
1.35
1.45
1
2
1.5
500
67,900
11.59
216131
SEFFNER
FS
12057
C
0
2
1
0.1
0.14
88
99
93.5
1
8
1.35
1.45
1
5
3
1,800
69,700
11.89
216131
SEFFNER
FS
12057
C
0
2
1
0.1
0.43
88
99
93.5
1
8
1.35
1.45
1
5
3
1,800
71,500
12.20
216131
SEFFNER
FS
12057
C
0
2
1
0.1
0.43
88
99
93.5
1
8
1.35
1.45
1
5
3
1,700
73,200
12.49
216131
SEFFNER
FS
12057
C
0
2
1
0.1
1.03
88
99
93.5
1
8
1.35
1.45
1
5
3
1,900
75,100
12.82
215543
POMELLO
FS
12051
C
0
5
2.5
0.1
0.62
92
99
95.5
0
2
1.35
1.65
0
1
0.5
2,600
77,700
13.26
215543
POMELLO
FS
12097
C
0
5
2.5
0.1
0.01
92
99
95.5
0
2
1.35
1.65
0
1
0.5
4,500
82,200
14.03
215634
CASSIA
FS
12097
C
0
2
1
0.1
0.02
93
98
95.5
1
4
1.3
1.55
0
1
0.5
1,200
83,400
14.23
215634
CASSIA
FS
12049
C
0
2
1
0.1
0.96
93
98
95.5
1
4
1.3
1.55
0
1
0.5
700
84,100
14.35
215634
CASSIA
FS
12049
C
0
2
1
0.1
0.61
93
98
95.5
1
4
1.3
1.55
0
1
0.5
700
84,800
14.47
215542
POMELLO
FS
12049
C
0
2
1
0.1
0.52
92
99
95.5
0
2
1.35
1.65
0
1
0.5
600
85,400
14.57
215542
POMELLO
FS
12081
C
0
2
1
0.1
0.06
92
99
95.5
0
2
1.35
1.65
0
1
0.5
2,600
88,000
15.02
215542
POMELLO
FS
12049
C
0
2
1
0.1
0.96
92
99
95.5
0
2
1.35
1.65
0
1
0.5
700
88,700
15.14
215542
POMELLO
FS
12049
C
0
2
1
0.1
0.61
92
99
95.5
0
2
1.35
1.65
0
1
0.5
600
89,300
15.24
215542
POMELLO
FS
12049
C
0
2
1
0.1
0.02
92
99
95.5
0
2
1.35
1.65
0
1
0.5
600
89,900
15.34
215542
POMELLO
FS
12049
C
0
2
1
0.1
0.61
92
99
95.5
0
2
1.35
1.65
0
1
0.5
700
90,600
15.46
215544
POMELLO
S
12009
C
0
2
1
0.1
0.09
92
99
95.5
0
2
1.35
1.65
0
1
0.5
1,200
91,800
15.67
215536
WINDER
LS
12111
B/
D
0
2
1
0.15
0.06
75
88
81.5
6
8
1.45
1.65
0
0
0
1,300
93,100
15.89
215487
CHOBEE
LFS
12061
B/
D
0
2
1
0.1
0.07
75
88
81.5
7
15
1.45
1.5
2
7
4.5
300
93,400
15.94
215487
CHOBEE
LFS
12061
B/
D
0
2
1
0.1
0.03
75
88
81.5
7
15
1.45
1.5
2
7
4.5
600
94,000
16.04
215487
CHOBEE
LFS
12021
B/
D
0
2
1
0.1
0.06
75
88
81.5
7
15
1.45
1.5
2
7
4.5
1,300
95,300
16.26
215487
CHOBEE
LFS
12021
B/
D
0
2
1
0.1
0.02
75
88
81.5
7
15
1.45
1.5
2
7
4.5
1,300
96,600
16.48
215487
CHOBEE
LFS
12021
B/
D
0
2
1
0.1
0.02
75
88
81.5
7
15
1.45
1.5
2
7
4.5
1,300
97,900
16.71
215489
CHOBEE
LS
12111
B/
D
0
2
1
0.1
0.05
75
88
81.5
7
15
1.45
1.5
2
7
4.5
1,300
99,200
16.93
216124
WABASSO
S
12071
B/
D
0
2
1
0.1
0.04
75
95
85
1
6
1.25
1.45
1
4
2.5
4,100
103,300
17.63
215663
DELRAY
FS
12081
B/
D
0
2
1
0.1
0.04
80
95
87.5
3
13
1.35
1.45
2
5
3.5
2,600
105,900
18.07
215663
DELRAY
FS
12117
B/
D
0
2
1
0.1
0.06
80
95
87.5
3
13
1.35
1.45
2
5
3.5
900
106,800
18.23
215707
MANATEE
LFS
12061
B/
D
0
2
1
0.1
0.01
85
92
88.5
2
8
1.2
1.4
4
10
7
300
107,100
18.28
215707
MANATEE
LFS
12061
B/
D
0
2
1
0.1
0.36
85
92
88.5
2
8
1.2
1.4
4
10
7
500
107,600
18.36
215707
MANATEE
LFS
12061
B/
D
0
2
1
0.1
0.08
85
92
88.5
2
8
1.2
1.4
4
10
7
300
107,900
18.41
215993
BRADENTON
FS
12081
B/
D
0
2
1
0.1
0.07
88
95
91.5
1
6
1.25
1.5
2
8
5
700
108,600
18.53
215993
BRADENTON
FS
12081
B/
D
0
2
1
0.1
0.07
88
95
91.5
1
6
1.25
1.5
2
8
5
600
109,200
18.63
Soils
Surveyed
for
"
Fruit"
Production
in
Southern
Florida
Flatwoods
(
MLRA
155)
Ranked
by
Runoff
Potential
NRIPTR
S5NAME
SURFTXT
FIPS
HYDGRP
LOSLOPE
HISLOPE
AVGSLOPE
UKFACT
USLE92
SANDLOW
SANDHI
SANDAV
CLAYL
CLAYH
BDL
BDH
OML
OMH
OMAV
ACRES
CUM_
AC
CUM_
PCT
215533
WINDER
FS
12061
B/
D
0
2
1
0.1
0.01
88
98
93
1
6
1.4
1.65
0.1
2
1.05
600
109,800
18.74
215533
WINDER
FS
12061
B/
D
0
2
1
0.1
0.01
88
98
93
1
6
1.4
1.65
0.1
2
1.05
500
110,300
18.82
215533
WINDER
FS
12061
B/
D
0
2
1
0.1
0.01
88
98
93
1
6
1.4
1.65
0.1
2
1.05
500
110,800
18.91
215533
WINDER
FS
12061
B/
D
0
2
1
0.1
0.01
88
98
93
1
6
1.4
1.65
0.1
2
1.05
600
111,400
19.01
215533
WINDER
FS
12061
B/
D
0
2
1
0.1
0.29
88
98
93
1
6
1.4
1.65
0.1
2
1.05
500
111,900
19.10
215533
WINDER
FS
12061
B/
D
0
2
1
0.1
0.07
88
98
93
1
6
1.4
1.65
0.1
2
1.05
300
112,200
19.15
215533
WINDER
FS
12061
B/
D
0
2
1
0.1
0.03
88
98
93
1
6
1.4
1.65
0.1
2
1.05
600
112,800
19.25
215533
WINDER
FS
12061
B/
D
0
2
1
0.1
0.13
88
98
93
1
6
1.4
1.65
0.1
2
1.05
500
113,300
19.33
215533
WINDER
FS
12061
B/
D
0
2
1
0.1
0.03
88
98
93
1
6
1.4
1.65
0.1
2
1.05
600
113,900
19.44
215533
WINDER
FS
12061
B/
D
0
2
1
0.1
0.31
88
98
93
1
6
1.4
1.65
0.1
2
1.05
600
114,500
19.54
215533
WINDER
FS
12061
B/
D
0
2
1
0.1
0.01
88
98
93
1
6
1.4
1.65
0.1
2
1.05
600
115,100
19.64
215533
WINDER
FS
12061
B/
D
0
2
1
0.1
0.03
88
98
93
1
6
1.4
1.65
0.1
2
1.05
500
115,600
19.73
215537
WINDER
S
12111
B/
D
0
2
1
0.1
0.05
88
98
93
1
6
1.4
1.65
0.1
2
1.05
800
116,400
19.86
215537
WINDER
S
12111
B/
D
0
2
1
0.1
0.01
88
98
93
1
6
1.4
1.65
0.1
2
1.05
1,200
117,600
20.07
215537
WINDER
S
12111
B/
D
0
2
1
0.1
0.05
88
98
93
1
6
1.4
1.65
0.1
2
1.05
800
118,400
20.20
215537
WINDER
S
12111
B/
D
0
2
1
0.1
0.53
88
98
93
1
6
1.4
1.65
0.1
2
1.05
800
119,200
20.34
215537
WINDER
S
12111
B/
D
0
2
1
0.1
0.07
88
98
93
1
6
1.4
1.65
0.1
2
1.05
800
120,000
20.48
215537
WINDER
S
12111
B/
D
0
2
1
0.1
0.07
88
98
93
1
6
1.4
1.65
0.1
2
1.05
900
120,900
20.63
215537
WINDER
S
12085
B/
D
0
2
1
0.1
0.06
88
98
93
1
6
1.4
1.65
0.1
2
1.05
400
121,300
20.70
215537
WINDER
S
12085
B/
D
0
2
1
0.1
0.07
88
98
93
1
6
1.4
1.65
0.1
2
1.05
500
121,800
20.78
215537
WINDER
S
12085
B/
D
0
2
1
0.1
0.09
88
98
93
1
6
1.4
1.65
0.1
2
1.05
500
122,300
20.87
215537
WINDER
S
12111
B/
D
0
2
1
0.1
0.07
88
98
93
1
6
1.4
1.65
0.1
2
1.05
800
123,100
21.01
215537
WINDER
S
12085
B/
D
0
2
1
0.1
0.05
88
98
93
1
6
1.4
1.65
0.1
2
1.05
500
123,600
21.09
215537
WINDER
S
12085
B/
D
0
2
1
0.1
0.06
88
98
93
1
6
1.4
1.65
0.1
2
1.05
500
124,100
21.18
215537
WINDER
S
12111
B/
D
0
2
1
0.1
0.14
88
98
93
1
6
1.4
1.65
0.1
2
1.05
800
124,900
21.31
215438
BOCA
FS
12071
B/
D
0
2
1
0.1
1.12
88
98
93
1
5
1.3
1.55
1
3
2
900
125,800
21.47
215438
BOCA
FS
12071
B/
D
0
2
1
0.1
0.04
88
98
93
1
5
1.3
1.55
1
3
2
4,100
129,900
22.17
215438
BOCA
FS
12085
B/
D
0
2
1
0.1
0.01
88
98
93
1
5
1.3
1.55
1
3
2
500
130,400
22.25
215438
BOCA
FS
12051
B/
D
0
2
1
0.1
0.02
88
98
93
1
5
1.3
1.55
1
3
2
3,000
133,400
22.76
215438
BOCA
FS
12061
B/
D
0
2
1
0.1
0.01
88
98
93
1
5
1.3
1.55
1
3
2
400
133,800
22.83
215438
BOCA
FS
12051
B/
D
0
2
1
0.1
0.06
88
98
93
1
5
1.3
1.55
1
3
2
3,200
137,000
23.38
215438
BOCA
FS
12051
B/
D
0
2
1
0.1
0.93
88
98
93
1
5
1.3
1.55
1
3
2
3,200
140,200
23.92
215241
POMONA
FS
12049
B/
D
0
2
1
0.1
1.01
88
98
93
1
6
1.1
1.5
1
4
2.5
1,500
141,700
24.18
215574
SMYRNA
FS
12049
B/
D
0
2
1
0.1
0.96
88
98
93
1
6
1.35
1.45
1
5
3
1,500
143,200
24.44
215574
SMYRNA
FS
12049
B/
D
0
2
1
0.1
0.96
88
98
93
1
6
1.35
1.45
1
5
3
1,600
144,800
24.71
215574
SMYRNA
FS
12049
B/
D
0
2
1
0.1
0.96
88
98
93
1
6
1.35
1.45
1
5
3
1,500
146,300
24.97
215574
SMYRNA
FS
12097
B/
D
0
2
1
0.1
0
88
98
93
1
6
1.35
1.45
1
5
3
3,100
149,400
25.49
215574
SMYRNA
FS
12097
B/
D
0
2
1
0.1
0.01
88
98
93
1
6
1.35
1.45
1
5
3
1,400
150,800
25.73
215574
SMYRNA
FS
12097
B/
D
0
2
1
0.1
0.56
88
98
93
1
6
1.35
1.45
1
5
3
3,100
153,900
26.26
215574
SMYRNA
FS
12097
B/
D
0
2
1
0.1
0.01
88
98
93
1
6
1.35
1.45
1
5
3
3,100
157,000
26.79
215574
SMYRNA
FS
12049
B/
D
0
2
1
0.1
0.58
88
98
93
1
6
1.35
1.45
1
5
3
1,500
158,500
27.05
215574
SMYRNA
FS
12097
B/
D
0
2
1
0.1
0.01
88
98
93
1
6
1.35
1.45
1
5
3
1,300
159,800
27.27
215574
SMYRNA
FS
12049
B/
D
0
2
1
0.1
0.02
88
98
93
1
6
1.35
1.45
1
5
3
1,500
161,300
27.53
215574
SMYRNA
FS
12049
B/
D
0
2
1
0.1
0.65
88
98
93
1
6
1.35
1.45
1
5
3
1,500
162,800
27.78
215574
SMYRNA
FS
12027
B/
D
0
2
1
0.1
0.02
88
98
93
1
6
1.35
1.45
1
5
3
1,800
164,600
28.09
Soils
Surveyed
for
"
Fruit"
Production
in
Southern
Florida
Flatwoods
(
MLRA
155)
Ranked
by
Runoff
Potential
NRIPTR
S5NAME
SURFTXT
FIPS
HYDGRP
LOSLOPE
HISLOPE
AVGSLOPE
UKFACT
USLE92
SANDLOW
SANDHI
SANDAV
CLAYL
CLAYH
BDL
BDH
OML
OMH
OMAV
ACRES
CUM_
AC
CUM_
PCT
215574
SMYRNA
FS
12027
B/
D
0
2
1
0.1
0.36
88
98
93
1
6
1.35
1.45
1
5
3
1,700
166,300
28.38
215574
SMYRNA
FS
12027
B/
D
0
2
1
0.1
0.36
88
98
93
1
6
1.35
1.45
1
5
3
1,600
167,900
28.65
215574
SMYRNA
FS
12027
B/
D
0
2
1
0.1
0.54
88
98
93
1
6
1.35
1.45
1
5
3
1,800
169,700
28.96
215574
SMYRNA
FS
12027
B/
D
0
2
1
0.1
0.54
88
98
93
1
6
1.35
1.45
1
5
3
1,700
171,400
29.25
215574
SMYRNA
FS
12049
B/
D
0
2
1
0.1
0.76
88
98
93
1
6
1.35
1.45
1
5
3
1,600
173,000
29.52
215574
SMYRNA
FS
12049
B/
D
0
2
1
0.1
0.96
88
98
93
1
6
1.35
1.45
1
5
3
1,400
174,400
29.76
215574
SMYRNA
FS
12049
B/
D
0
2
1
0.1
0.61
88
98
93
1
6
1.35
1.45
1
5
3
600
175,000
29.86
215574
SMYRNA
FS
12049
B/
D
0
2
1
0.1
0.65
88
98
93
1
6
1.35
1.45
1
5
3
1,500
176,500
30.12
215574
SMYRNA
FS
12049
B/
D
0
2
1
0.1
0.65
88
98
93
1
6
1.35
1.45
1
5
3
1,500
178,000
30.38
215575
SMYRNA
S
12049
B/
D
0
2
1
0.1
0.76
88
98
93
1
6
1.35
1.45
1
5
3
1,500
179,500
30.63
215677
ONA
FS
12057
B/
D
0
2
1
0.1
0.31
90
97
93.5
1
7
1.4
1.55
1
5
3
700
180,200
30.75
215677
ONA
FS
12095
B/
D
0
2
1
0.1
0.04
90
97
93.5
1
7
1.4
1.55
1
5
3
1,700
181,900
31.04
215677
ONA
FS
12081
B/
D
0
2
1
0.1
0.1
90
97
93.5
1
7
1.4
1.55
1
5
3
2,600
184,500
31.48
215677
ONA
FS
12095
B/
D
0
2
1
0.1
0.03
90
97
93.5
1
7
1.4
1.55
1
5
3
3,700
188,200
32.12
215677
ONA
FS
12049
B/
D
0
2
1
0.1
0.61
90
97
93.5
1
7
1.4
1.55
1
5
3
1,500
189,700
32.37
215677
ONA
FS
12057
B/
D
0
2
1
0.1
0.31
90
97
93.5
1
7
1.4
1.55
1
5
3
2,000
191,700
32.71
215677
ONA
FS
12049
B/
D
0
2
1
0.1
1.18
90
97
93.5
1
7
1.4
1.55
1
5
3
1,500
193,200
32.97
215677
ONA
FS
12049
B/
D
0
2
1
0.1
0.61
90
97
93.5
1
7
1.4
1.55
1
5
3
1,500
194,700
33.23
215677
ONA
FS
12049
B/
D
0
2
1
0.1
0.58
90
97
93.5
1
7
1.4
1.55
1
5
3
1,500
196,200
33.48
215677
ONA
FS
12049
B/
D
0
2
1
0.1
0.76
90
97
93.5
1
7
1.4
1.55
1
5
3
1,500
197,700
33.74
215340
POMPANO
S
12051
B/
D
0
2
1
0.1
0.12
88
99
93.5
0
5
1.3
1.5
1
5
3
3,000
200,700
34.25
215678
ST.
JOHNS
FS
12057
B/
D
0
2
1
0.1
0.14
90
97
93.5
1
4
1.3
1.5
2
4
3
200
200,900
34.28
215678
ST.
JOHNS
FS
12057
B/
D
0
2
1
0.1
0.11
90
97
93.5
1
4
1.3
1.5
2
4
3
5,700
206,600
35.26
215678
ST.
JOHNS
FS
12057
B/
D
0
2
1
0.1
0.14
90
97
93.5
1
4
1.3
1.5
2
4
3
400
207,000
35.32
215678
ST.
JOHNS
FS
12057
B/
D
0
2
1
0.1
0.14
90
97
93.5
1
4
1.3
1.5
2
4
3
1,700
208,700
35.61
215693
CHARLOTTE
FS
12093
B/
D
0
2
1
0.1
0.46
90
98
94
1
5
1.35
1.45
0
2
1
2,200
210,900
35.99
215472
IMMOKALEE
S
12051
B/
D
0
5
2.5
0.1
0.46
90
98
94
1
5
1.2
1.5
1
2
1.5
3,100
214,000
36.52
215466
IMMOKALEE
FS
12027
B/
D
0
2
1
0.1
0.01
90
98
94
1
5
1.2
1.5
1
2
1.5
1,800
215,800
36.83
215466
IMMOKALEE
FS
12027
B/
D
0
2
1
0.1
0.54
90
98
94
1
5
1.2
1.5
1
2
1.5
1,800
217,600
37.13
215466
IMMOKALEE
FS
12049
B/
D
0
2
1
0.1
0.58
90
98
94
1
5
1.2
1.5
1
2
1.5
1,500
219,100
37.39
215466
IMMOKALEE
FS
12027
B/
D
0
2
1
0.1
0.54
90
98
94
1
5
1.2
1.5
1
2
1.5
1,800
220,900
37.70
215466
IMMOKALEE
FS
12117
B/
D
0
2
1
0.1
0.05
90
98
94
1
5
1.2
1.5
1
2
1.5
1,100
222,000
37.88
215466
IMMOKALEE
FS
12027
B/
D
0
2
1
0.1
0.58
90
98
94
1
5
1.2
1.5
1
2
1.5
1,800
223,800
38.19
215466
IMMOKALEE
FS
12021
B/
D
0
2
1
0.1
0.05
90
98
94
1
5
1.2
1.5
1
2
1.5
4,900
228,700
39.03
215466
IMMOKALEE
FS
12021
B/
D
0
2
1
0.1
1.02
90
98
94
1
5
1.2
1.5
1
2
1.5
4,900
233,600
39.86
215466
IMMOKALEE
FS
12021
B/
D
0
2
1
0.1
0.05
90
98
94
1
5
1.2
1.5
1
2
1.5
4,900
238,500
40.70
215466
IMMOKALEE
FS
12021
B/
D
0
2
1
0.1
0.04
90
98
94
1
5
1.2
1.5
1
2
1.5
4,900
243,400
41.54
215466
IMMOKALEE
FS
12027
B/
D
0
2
1
0.1
0.79
90
98
94
1
5
1.2
1.5
1
2
1.5
1,700
245,100
41.83
215466
IMMOKALEE
FS
12021
B/
D
0
2
1
0.1
0.03
90
98
94
1
5
1.2
1.5
1
2
1.5
1,400
246,500
42.06
215471
IMMOKALEE
S
12051
B/
D
0
2
1
0.1
0.29
90
98
94
1
5
1.2
1.5
1
2
1.5
3,000
249,500
42.58
215471
IMMOKALEE
S
12055
B/
D
0
2
1
0.1
0.03
90
98
94
1
5
1.2
1.5
1
2
1.5
1,300
250,800
42.80
215471
IMMOKALEE
S
12055
B/
D
0
2
1
0.1
0.03
90
98
94
1
5
1.2
1.5
1
2
1.5
1,400
252,200
43.04
215471
IMMOKALEE
S
12015
B/
D
0
2
1
0.1
0.04
90
98
94
1
5
1.2
1.5
1
2
1.5
5,100
257,300
43.91
215471
IMMOKALEE
S
12015
B/
D
0
2
1
0.1
0.04
90
98
94
1
5
1.2
1.5
1
2
1.5
5,200
262,500
44.80
215471
IMMOKALEE
S
12009
B/
D
0
2
1
0.1
0.06
90
98
94
1
5
1.2
1.5
1
2
1.5
1,100
263,600
44.98
Soils
Surveyed
for
"
Fruit"
Production
in
Southern
Florida
Flatwoods
(
MLRA
155)
Ranked
by
Runoff
Potential
NRIPTR
S5NAME
SURFTXT
FIPS
HYDGRP
LOSLOPE
HISLOPE
AVGSLOPE
UKFACT
USLE92
SANDLOW
SANDHI
SANDAV
CLAYL
CLAYH
BDL
BDH
OML
OMH
OMAV
ACRES
CUM_
AC
CUM_
PCT
215511
OLDSMAR
FS
12051
B/
D
0
2
1
0.1
0.76
90
98
94
0
2
1.48
1.61
1
2
1.5
3,200
266,800
45.53
215511
OLDSMAR
FS
12061
B/
D
0
2
1
0.1
0.08
90
98
94
0
2
1.48
1.61
1
2
1.5
400
267,200
45.60
215511
OLDSMAR
FS
12061
B/
D
0
2
1
0.1
0.03
90
98
94
0
2
1.48
1.61
1
2
1.5
300
267,500
45.65
215511
OLDSMAR
FS
12061
B/
D
0
2
1
0.1
0.03
90
98
94
0
2
1.48
1.61
1
2
1.5
400
267,900
45.72
215511
OLDSMAR
FS
12051
B/
D
0
2
1
0.1
0.02
90
98
94
0
2
1.48
1.61
1
2
1.5
3,300
271,200
46.28
215511
OLDSMAR
FS
12085
B/
D
0
2
1
0.1
0.06
90
98
94
0
2
1.48
1.61
1
2
1.5
500
271,700
46.37
215511
OLDSMAR
FS
12051
B/
D
0
2
1
0.1
0.02
90
98
94
0
2
1.48
1.61
1
2
1.5
3,200
274,900
46.91
215511
OLDSMAR
FS
12021
B/
D
0
2
1
0.1
0.06
90
98
94
0
2
1.48
1.61
1
2
1.5
1,400
276,300
47.15
215511
OLDSMAR
FS
12043
B/
D
0
2
1
0.1
0.07
90
98
94
0
2
1.48
1.61
1
2
1.5
2,700
279,000
47.61
215511
OLDSMAR
FS
12021
B/
D
0
2
1
0.1
0.2
90
98
94
0
2
1.48
1.61
1
2
1.5
1,400
280,400
47.85
215511
OLDSMAR
FS
12021
B/
D
0
2
1
0.1
0.22
90
98
94
0
2
1.48
1.61
1
2
1.5
1,400
281,800
48.09
215511
OLDSMAR
FS
12043
B/
D
0
2
1
0.1
0.07
90
98
94
0
2
1.48
1.61
1
2
1.5
2,700
284,500
48.55
215511
OLDSMAR
FS
12021
B/
D
0
2
1
0.1
0.22
90
98
94
0
2
1.48
1.61
1
2
1.5
1,300
285,800
48.77
216078
OLDSMAR
S
12051
B/
D
0
2
1
0.1
0
90
98
94
1
3
1.4
1.65
1
2
1.5
100
285,900
48.79
216078
OLDSMAR
S
12051
B/
D
0
2
1
0.1
0
90
98
94
1
3
1.4
1.65
1
2
1.5
3,300
289,200
49.35
216078
OLDSMAR
S
12051
B/
D
0
2
1
0.1
0.01
90
98
94
1
3
1.4
1.65
1
2
1.5
3,100
292,300
49.88
216118
PINEDA
FS
12051
B/
D
0
1
0.5
0.15
0.03
90
98
94
1
3
1.4
1.65
1
2
1.5
3,000
295,300
50.39
216118
PINEDA
FS
12051
B/
D
0
1
0.5
0.15
0.09
90
98
94
1
3
1.4
1.65
1
2
1.5
3,300
298,600
50.96
216118
PINEDA
FS
12051
B/
D
0
1
0.5
0.15
1.39
90
98
94
1
3
1.4
1.65
1
2
1.5
3,300
301,900
51.52
215689
WAVELAND
FS
12085
B/
D
0
2
1
0.1
0.08
90
98
94
0
1
1.3
1.6
1
3
2
500
302,400
51.60
215689
WAVELAND
FS
12085
B/
D
0
2
1
0.1
0.07
90
98
94
0
1
1.3
1.6
1
3
2
500
302,900
51.69
215689
WAVELAND
FS
12081
B/
D
0
2
1
0.1
0.06
90
98
94
0
1
1.3
1.6
1
3
2
2,700
305,600
52.15
215327
HOLOPAW
FS
12049
B/
D
0
2
1
0.1
0.96
90
98
94
1
7
1.35
1.6
1
4
2.5
600
306,200
52.25
215327
HOLOPAW
FS
12021
B/
D
0
2
1
0.1
0.03
90
98
94
1
7
1.35
1.6
1
4
2.5
1,400
307,600
52.49
215327
HOLOPAW
FS
12021
B/
D
0
2
1
0.1
0.06
90
98
94
1
7
1.35
1.6
1
4
2.5
1,400
309,000
52.73
215328
HOLOPAW
S
12051
B/
D
0
2
1
0.1
0
90
98
94
1
7
1.35
1.6
1
4
2.5
3,200
312,200
53.28
215328
HOLOPAW
S
12051
B/
D
0
2
1
0.1
0
90
98
94
1
7
1.35
1.6
1
4
2.5
3,300
315,500
53.84
215328
HOLOPAW
S
12051
B/
D
0
2
1
0.1
0.03
90
98
94
1
7
1.35
1.6
1
4
2.5
3,300
318,800
54.40
215328
HOLOPAW
S
12051
B/
D
0
2
1
0.1
0
90
98
94
1
7
1.35
1.6
1
4
2.5
3,200
322,000
54.95
215328
HOLOPAW
S
12051
B/
D
0
2
1
0.1
0
90
98
94
1
7
1.35
1.6
1
4
2.5
3,300
325,300
55.51
216165
HOLOPAW
S
12051
B/
D
0
2
1
0.1
0.01
90
98
94
1
7
1.35
1.6
1
4
2.5
3,100
328,400
56.04
215675
MALABAR
FS
12051
B/
D
0
2
1
0.1
0
90
98
94
0
4
1.35
1.55
1
4
2.5
3,000
331,400
56.55
215675
MALABAR
FS
12071
B/
D
0
2
1
0.1
0.04
90
98
94
0
4
1.35
1.55
1
4
2.5
4,100
335,500
57.25
215676
MALABAR
S
12085
B/
D
0
2
1
0.1
0.08
90
98
94
0
4
1.35
1.55
1
4
2.5
500
336,000
57.34
216080
PUNTA
FS
12071
B/
D
0
2
1
0.1
0.68
90
98
94
0
4
1.35
1.5
1
4
2.5
600
336,600
57.44
215713
SALERNO
S
12085
B/
D
0
2
1
0.1
0.01
90
98
94
1
4
1.35
1.5
1
4
2.5
700
337,300
57.56
215713
SALERNO
S
12085
B/
D
0
2
1
0.1
0.07
90
98
94
1
4
1.35
1.5
1
4
2.5
400
337,700
57.63
215684
VALKARIA
FS
12027
B/
D
0
2
1
0.1
0.71
90
98
94
1
3
1.35
1.5
1
4
2.5
1,800
339,500
57.94
215684
VALKARIA
FS
12027
B/
D
0
2
1
0.1
0.71
90
98
94
1
3
1.35
1.5
1
4
2.5
1,800
341,300
58.24
215684
VALKARIA
FS
12027
B/
D
0
2
1
0.1
0.58
90
98
94
1
3
1.35
1.5
1
4
2.5
1,700
343,000
58.53
215684
VALKARIA
FS
12027
B/
D
0
2
1
0.1
0.54
90
98
94
1
3
1.35
1.5
1
4
2.5
1,800
344,800
58.84
215684
VALKARIA
FS
12027
B/
D
0
2
1
0.1
0.54
90
98
94
1
3
1.35
1.5
1
4
2.5
1,800
346,600
59.15
215685
VALKARIA
S
12009
B/
D
0
2
1
0.1
0.06
90
98
94
1
3
1.35
1.5
1
4
2.5
1,400
348,000
59.39
215531
WABASSO
FS
12061
B/
D
0
2
1
0.1
0.01
90
98
94
1
5
1.25
1.5
1
4
2.5
500
348,500
59.47
215531
WABASSO
FS
12081
B/
D
0
2
1
0.1
0.1
90
98
94
1
5
1.25
1.5
1
4
2.5
1,400
349,900
59.71
Soils
Surveyed
for
"
Fruit"
Production
in
Southern
Florida
Flatwoods
(
MLRA
155)
Ranked
by
Runoff
Potential
NRIPTR
S5NAME
SURFTXT
FIPS
HYDGRP
LOSLOPE
HISLOPE
AVGSLOPE
UKFACT
USLE92
SANDLOW
SANDHI
SANDAV
CLAYL
CLAYH
BDL
BDH
OML
OMH
OMAV
ACRES
CUM_
AC
CUM_
PCT
215531
WABASSO
FS
12061
B/
D
0
2
1
0.1
0.01
90
98
94
1
5
1.25
1.5
1
4
2.5
500
350,400
59.80
215531
WABASSO
FS
12061
B/
D
0
2
1
0.1
0.01
90
98
94
1
5
1.25
1.5
1
4
2.5
500
350,900
59.88
215531
WABASSO
FS
12061
B/
D
0
2
1
0.1
0.01
90
98
94
1
5
1.25
1.5
1
4
2.5
400
351,300
59.95
215531
WABASSO
FS
12061
B/
D
0
2
1
0.1
0.01
90
98
94
1
5
1.25
1.5
1
4
2.5
500
351,800
60.03
215531
WABASSO
FS
12061
B/
D
0
2
1
0.1
0.1
90
98
94
1
5
1.25
1.5
1
4
2.5
500
352,300
60.12
215531
WABASSO
FS
12021
B/
D
0
2
1
0.1
1.02
90
98
94
1
5
1.25
1.5
1
4
2.5
4,700
357,000
60.92
215531
WABASSO
FS
12061
B/
D
0
2
1
0.1
0.01
90
98
94
1
5
1.25
1.5
1
4
2.5
500
357,500
61.01
215532
WABASSO
S
12111
B/
D
0
2
1
0.1
0.11
90
98
94
1
5
1.25
1.5
1
4
2.5
1,300
358,800
61.23
215532
WABASSO
S
12111
B/
D
0
2
1
0.1
0.04
90
98
94
1
5
1.25
1.5
1
4
2.5
1,200
360,000
61.43
215532
WABASSO
S
12111
B/
D
0
2
1
0.1
0.03
90
98
94
1
5
1.25
1.5
1
4
2.5
600
360,600
61.54
215532
WABASSO
S
12111
B/
D
0
2
1
0.1
0.01
90
98
94
1
5
1.25
1.5
1
4
2.5
900
361,500
61.69
215532
WABASSO
S
12085
B/
D
0
2
1
0.1
0.07
90
98
94
1
5
1.25
1.5
1
4
2.5
500
362,000
61.77
215532
WABASSO
S
12015
B/
D
0
2
1
0.1
0.04
90
98
94
1
5
1.25
1.5
1
4
2.5
5,300
367,300
62.68
215532
WABASSO
S
12051
B/
D
0
2
1
0.1
0.04
90
98
94
1
5
1.25
1.5
1
4
2.5
3,300
370,600
63.24
215532
WABASSO
S
12085
B/
D
0
2
1
0.1
0.05
90
98
94
1
5
1.25
1.5
1
4
2.5
500
371,100
63.33
215532
WABASSO
S
12015
B/
D
0
2
1
0.1
0.04
90
98
94
1
5
1.25
1.5
1
4
2.5
5,200
376,300
64.22
215532
WABASSO
S
12051
B/
D
0
2
1
0.1
0.02
90
98
94
1
5
1.25
1.5
1
4
2.5
3,000
379,300
64.73
215532
WABASSO
S
12085
B/
D
0
2
1
0.1
0.07
90
98
94
1
5
1.25
1.5
1
4
2.5
500
379,800
64.81
215474
MYAKKA
FS
12057
B/
D
0
2
1
0.1
0.14
90
98
94
1
3
1.25
1.45
2
5
3.5
5,700
385,500
65.78
215474
MYAKKA
FS
12057
B/
D
0
2
1
0.1
0.14
90
98
94
1
3
1.25
1.45
2
5
3.5
5,700
391,200
66.76
215474
MYAKKA
FS
12061
B/
D
0
2
1
0.1
0.34
90
98
94
1
3
1.25
1.45
2
5
3.5
600
391,800
66.86
215474
MYAKKA
FS
12117
B/
D
0
2
1
0.1
0.1
90
98
94
1
3
1.25
1.45
2
5
3.5
1,200
393,000
67.06
215474
MYAKKA
FS
12081
B/
D
0
2
1
0.1
0.08
90
98
94
1
3
1.25
1.45
2
5
3.5
2,600
395,600
67.51
215474
MYAKKA
FS
12049
B/
D
0
2
1
0.1
0.61
90
98
94
1
3
1.25
1.45
2
5
3.5
700
396,300
67.63
215474
MYAKKA
FS
12105
B/
D
0
2
1
0.1
0.84
90
98
94
1
3
1.25
1.45
2
5
3.5
20,400
416,700
71.11
215474
MYAKKA
FS
12093
B/
D
0
2
1
0.1
0.66
90
98
94
1
3
1.25
1.45
2
5
3.5
2,100
418,800
71.47
215474
MYAKKA
FS
12057
B/
D
0
2
1
0.1
0.43
90
98
94
1
3
1.25
1.45
2
5
3.5
1,800
420,600
71.77
215474
MYAKKA
FS
12049
B/
D
0
2
1
0.1
0.61
90
98
94
1
3
1.25
1.45
2
5
3.5
1,500
422,100
72.03
215474
MYAKKA
FS
12021
B/
D
0
2
1
0.1
0.07
90
98
94
1
3
1.25
1.45
2
5
3.5
1,400
423,500
72.27
215474
MYAKKA
FS
12049
B/
D
0
2
1
0.1
0.76
90
98
94
1
3
1.25
1.45
2
5
3.5
1,500
425,000
72.53
215474
MYAKKA
FS
12021
B/
D
0
2
1
0.1
0.94
90
98
94
1
3
1.25
1.45
2
5
3.5
1,300
426,300
72.75
215474
MYAKKA
FS
12021
B/
D
0
2
1
0.1
0.06
90
98
94
1
3
1.25
1.45
2
5
3.5
1,300
427,600
72.97
215474
MYAKKA
FS
12027
B/
D
0
2
1
0.1
0.02
90
98
94
1
3
1.25
1.45
2
5
3.5
1,700
429,300
73.26
215474
MYAKKA
FS
12049
B/
D
0
2
1
0.1
1
90
98
94
1
3
1.25
1.45
2
5
3.5
1,500
430,800
73.52
215474
MYAKKA
FS
12049
B/
D
0
2
1
0.1
0.61
90
98
94
1
3
1.25
1.45
2
5
3.5
600
431,400
73.62
215474
MYAKKA
FS
12021
B/
D
0
2
1
0.1
0.06
90
98
94
1
3
1.25
1.45
2
5
3.5
1,500
432,900
73.87
215474
MYAKKA
FS
12049
B/
D
0
2
1
0.1
0.61
90
98
94
1
3
1.25
1.45
2
5
3.5
600
433,500
73.98
215477
MYAKKA
S
12099
B/
D
0
2
1
0.1
0.06
90
98
94
1
3
1.25
1.45
2
5
3.5
100
433,600
73.99
215477
MYAKKA
S
12111
B/
D
0
2
1
0.1
0.11
90
98
94
1
3
1.25
1.45
2
5
3.5
1,200
434,800
74.20
215477
MYAKKA
S
12099
B/
D
0
2
1
0.1
0.06
90
98
94
1
3
1.25
1.45
2
5
3.5
100
434,900
74.22
215477
MYAKKA
S
12009
B/
D
0
2
1
0.1
0.09
90
98
94
1
3
1.25
1.45
2
5
3.5
1,100
436,000
74.40
215477
MYAKKA
S
12099
B/
D
0
2
1
0.1
0.06
90
98
94
1
3
1.25
1.45
2
5
3.5
400
436,400
74.47
215477
MYAKKA
S
12099
B/
D
0
2
1
0.1
0.06
90
98
94
1
3
1.25
1.45
2
5
3.5
400
436,800
74.54
215477
MYAKKA
S
12051
B/
D
0
2
1
0.1
0.01
90
98
94
1
3
1.25
1.45
2
5
3.5
3,300
440,100
75.10
215477
MYAKKA
S
12099
B/
D
0
2
1
0.1
0.05
90
98
94
1
3
1.25
1.45
2
5
3.5
400
440,500
75.17
Soils
Surveyed
for
"
Fruit"
Production
in
Southern
Florida
Flatwoods
(
MLRA
155)
Ranked
by
Runoff
Potential
NRIPTR
S5NAME
SURFTXT
FIPS
HYDGRP
LOSLOPE
HISLOPE
AVGSLOPE
UKFACT
USLE92
SANDLOW
SANDHI
SANDAV
CLAYL
CLAYH
BDL
BDH
OML
OMH
OMAV
ACRES
CUM_
AC
CUM_
PCT
215939
ELRED
FS
12093
B/
D
0
2
1
0.1
0.66
90
99
94.5
1
8
1.3
1.6
0.5
6
3.25
2,100
442,600
75.53
215548
PINEDA
FS
12061
B/
D
0
2
1
0.1
0.06
92
98
95
1
6
1.25
1.6
0.5
6
3.25
500
443,100
75.61
215548
PINEDA
FS
12061
B/
D
0
2
1
0.1
0.01
92
98
95
1
6
1.25
1.6
0.5
6
3.25
500
443,600
75.70
215548
PINEDA
FS
12061
B/
D
0
2
1
0.1
0.06
92
98
95
1
6
1.25
1.6
0.5
6
3.25
400
444,000
75.77
215548
PINEDA
FS
12085
B/
D
0
2
1
0.1
0.08
92
98
95
1
6
1.25
1.6
0.5
6
3.25
500
444,500
75.85
215548
PINEDA
FS
12085
B/
D
0
2
1
0.1
0.07
92
98
95
1
6
1.25
1.6
0.5
6
3.25
500
445,000
75.94
215548
PINEDA
FS
12051
B/
D
0
2
1
0.1
0.03
92
98
95
1
6
1.25
1.6
0.5
6
3.25
3,200
448,200
76.48
215548
PINEDA
FS
12061
B/
D
0
2
1
0.1
0.07
92
98
95
1
6
1.25
1.6
0.5
6
3.25
600
448,800
76.59
215548
PINEDA
FS
12061
B/
D
0
2
1
0.1
0.07
92
98
95
1
6
1.25
1.6
0.5
6
3.25
500
449,300
76.67
215548
PINEDA
FS
12043
B/
D
0
2
1
0.1
0.01
92
98
95
1
6
1.25
1.6
0.5
6
3.25
2,600
451,900
77.12
215548
PINEDA
FS
12051
B/
D
0
2
1
0.1
0.03
92
98
95
1
6
1.25
1.6
0.5
6
3.25
3,200
455,100
77.66
215548
PINEDA
FS
12051
B/
D
0
2
1
0.1
0.02
92
98
95
1
6
1.25
1.6
0.5
6
3.25
3,200
458,300
78.21
215548
PINEDA
FS
12051
B/
D
0
2
1
0.1
0.03
92
98
95
1
6
1.25
1.6
0.5
6
3.25
3,100
461,400
78.74
215549
PINEDA
S
12111
B/
D
0
2
1
0.1
0.05
92
98
95
1
6
1.25
1.6
0.5
6
3.25
1,100
462,500
78.92
215549
PINEDA
S
12111
B/
D
0
2
1
0.1
0.07
92
98
95
1
6
1.25
1.6
0.5
6
3.25
1,100
463,600
79.11
215549
PINEDA
S
12111
B/
D
0
2
1
0.1
0.11
92
98
95
1
6
1.25
1.6
0.5
6
3.25
800
464,400
79.25
215549
PINEDA
S
12111
B/
D
0
2
1
0.1
0.05
92
98
95
1
6
1.25
1.6
0.5
6
3.25
1,300
465,700
79.47
215549
PINEDA
S
12085
B/
D
0
2
1
0.1
0.01
92
98
95
1
6
1.25
1.6
0.5
6
3.25
1,000
466,700
79.64
215549
PINEDA
S
12111
B/
D
0
2
1
0.1
0.13
92
98
95
1
6
1.25
1.6
0.5
6
3.25
800
467,500
79.78
215499
HALLANDALE
FS
12021
B/
D
0
2
1
0.1
0.03
94
98
96
0
3
1.2
1.45
1
2
1.5
1,400
468,900
80.02
216127
RIVIERA
S
12051
B/
D
0
2
1
0.1
0.03
95
98
96.5
1
5
1.2
1.45
0.5
4
2.25
3,300
472,200
80.58
216127
RIVIERA
S
12051
B/
D
0
2
1
0.1
0.03
95
98
96.5
1
5
1.2
1.45
0.5
4
2.25
3,300
475,500
81.14
216127
RIVIERA
S
12051
B/
D
0
2
1
0.1
0.03
95
98
96.5
1
5
1.2
1.45
0.5
4
2.25
3,300
478,800
81.71
216127
RIVIERA
S
12051
B/
D
0
2
1
0.1
0.57
95
98
96.5
1
5
1.2
1.45
0.5
4
2.25
3,100
481,900
82.24
216127
RIVIERA
S
12051
B/
D
0
2
1
0.1
0.03
95
98
96.5
1
5
1.2
1.45
0.5
4
2.25
3,200
485,100
82.78
215840
POPLE
S
12111
B/
D
0
2
1
0.1
0.04
95
98
96.5
2
6
1.25
1.45
0.5
6
3.25
1,300
486,400
83.00
215703
EAUGALLIE
FS
12115
B/
D
0
2
1
0.1
0.08
95
98
96.5
0
5
1.25
1.5
2
8
5
1,000
487,400
83.17
215703
EAUGALLIE
FS
12115
B/
D
0
2
1
0.1
0.06
95
98
96.5
0
5
1.25
1.5
2
8
5
1,100
488,500
83.36
215703
EAUGALLIE
FS
12115
B/
D
0
2
1
0.1
0.07
95
98
96.5
0
5
1.25
1.5
2
8
5
1,100
489,600
83.55
215703
EAUGALLIE
FS
12081
B/
D
0
2
1
0.1
0.09
95
98
96.5
0
5
1.25
1.5
2
8
5
2,600
492,200
83.99
215703
EAUGALLIE
FS
12061
B/
D
0
2
1
0.1
0.07
95
98
96.5
0
5
1.25
1.5
2
8
5
200
492,400
84.03
215703
EAUGALLIE
FS
12061
B/
D
0
2
1
0.1
0.09
95
98
96.5
0
5
1.25
1.5
2
8
5
300
492,700
84.08
215703
EAUGALLIE
FS
12027
B/
D
0
2
1
0.1
0.54
95
98
96.5
0
5
1.25
1.5
2
8
5
1,700
494,400
84.37
215703
EAUGALLIE
FS
12061
B/
D
0
2
1
0.1
0.06
95
98
96.5
0
5
1.25
1.5
2
8
5
200
494,600
84.40
215546
PINELLAS
FS
12085
B/
D
0
2
1
0.1
0.01
96
98
97
1
3
1.15
1.5
1
4
2.5
900
495,500
84.56
215546
PINELLAS
FS
12085
B/
D
0
2
1
0.1
0.01
96
98
97
1
3
1.15
1.5
1
4
2.5
1,000
496,500
84.73
215491
BASINGER
FS
12099
B/
D
0
2
1
0.1
0.04
96
99
97.5
0
4
1.4
1.55
0.5
2
1.25
300
496,800
84.78
215491
BASINGER
FS
12117
B/
D
0
2
1
0.1
0.06
96
99
97.5
0
4
1.4
1.55
0.5
2
1.25
800
497,600
84.91
215491
BASINGER
FS
12027
B/
D
0
2
1
0.1
0.54
96
99
97.5
0
4
1.4
1.55
0.5
2
1.25
1,800
499,400
85.22
215491
BASINGER
FS
12027
B/
D
0
2
1
0.1
0.54
96
99
97.5
0
4
1.4
1.55
0.5
2
1.25
1,800
501,200
85.53
215491
BASINGER
FS
12085
B/
D
0
2
1
0.1
0.08
96
99
97.5
0
4
1.4
1.55
0.5
2
1.25
500
501,700
85.61
215492
BASINGER
S
12051
B/
D
0
2
1
0.1
0.02
96
99
97.5
0
4
1.4
1.55
0.5
2
1.25
3,200
504,900
86.16
215492
BASINGER
S
12009
B/
D
0
2
1
0.1
0.06
96
99
97.5
0
4
1.4
1.55
0.5
2
1.25
1,400
506,300
86.40
215492
BASINGER
S
12051
B/
D
0
2
1
0.1
0.01
96
99
97.5
0
4
1.4
1.55
0.5
2
1.25
3,300
509,600
86.96
215492
BASINGER
S
12051
B/
D
0
2
1
0.1
0.01
96
99
97.5
0
4
1.4
1.55
0.5
2
1.25
3,400
513,000
87.54
Soils
Surveyed
for
"
Fruit"
Production
in
Southern
Florida
Flatwoods
(
MLRA
155)
Ranked
by
Runoff
Potential
NRIPTR
S5NAME
SURFTXT
FIPS
HYDGRP
LOSLOPE
HISLOPE
AVGSLOPE
UKFACT
USLE92
SANDLOW
SANDHI
SANDAV
CLAYL
CLAYH
BDL
BDH
OML
OMH
OMAV
ACRES
CUM_
AC
CUM_
PCT
215540
TEQUESTA
MUCK
12085
B/
D
0
2
1
0
0
100
100
100
0.2
0.4
35
60
47.5
500
513,500
87.63
215712
JONATHAN
S
12085
B
0
5
2.5
0.1
0.06
96
99
97.5
0
3
1.3
1.55
1
2
1.5
500
514,000
87.71
215711
JONATHAN
FS
12049
B
0
2
1
0.1
1.01
96
99
97.5
0
3
1.3
1.55
1
2
1.5
700
514,700
87.83
215343
GAINESVILLE
LFS
12057
A
0
5
2.5
0.15
0.17
72
87
79.5
4
10
1.4
1.55
2
4
3
2,200
516,900
88.21
215671
FORT
MEADE
LFS
12057
A
0
5
2.5
0.15
2.79
75
87
81
3
13
1.15
1.55
1
5
3
1,000
517,900
88.38
215671
FORT
MEADE
LFS
12057
A
0
5
2.5
0.15
2.79
75
87
81
3
13
1.15
1.55
1
5
3
1,600
519,500
88.65
215671
FORT
MEADE
LFS
12057
A
0
5
2.5
0.15
2.79
75
87
81
3
13
1.15
1.55
1
5
3
1,500
521,000
88.91
215484
COCOA
FS
12071
A
0
2
1
0.1
0.68
85
96
90.5
2
5
1.35
1.6
1
3
2
1,000
522,000
89.08
215645
LAKE
FS
12057
A
0
5
2.5
0.1
2.48
88
95
91.5
1
3
1.45
1.65
0.5
1
0.75
1,700
523,700
89.37
215311
APOPKA
FS
12117
A
0
5
2.5
0.1
1.03
90
97
93.5
0
3
1.45
1.6
0
2
1
1,500
525,200
89.62
215311
APOPKA
FS
12117
A
0
5
2.5
0.1
1.03
90
97
93.5
0
3
1.45
1.6
0
2
1
100
525,300
89.64
215311
APOPKA
FS
12049
A
0
5
2.5
0.1
2
90
97
93.5
0
3
1.45
1.6
0
2
1
600
525,900
89.74
215311
APOPKA
FS
12105
A
0
5
2.5
0.1
1.84
90
97
93.5
0
3
1.45
1.6
0
2
1
1,400
527,300
89.98
215311
APOPKA
FS
12049
A
0
5
2.5
0.1
0.61
90
97
93.5
0
3
1.45
1.6
0
2
1
1,600
528,900
90.26
215314
APOPKA
S
12117
A
0
5
2.5
0.1
0.04
90
97
93.5
0
3
1.45
1.6
0
2
1
300
529,200
90.31
215999
FLORAHOME
FS
12081
A
0
2
1
0.1
0.08
88
99
93.5
1
8
1.35
1.45
1
5
3
800
530,000
90.44
215694
ORLANDO
FS
12057
A
0
2
1
0.1
0.14
88
99
93.5
1
8
1.35
1.45
1
5
3
1,800
531,800
90.75
216143
QUARTZIPSAMENTS
FS
12009
A
0
5
2.5
0.1
0.07
90
98
94
1
3
1.5
1.65
0
0.5
0.25
1,100
532,900
90.94
215301
TAVARES
FS
12097
A
0
5
2.5
0.1
0.42
90
98
94
0
4
1.25
1.65
0.5
2
1.25
200
533,100
90.97
215301
TAVARES
FS
12101
A
0
5
2.5
0.1
0.27
90
98
94
0
4
1.25
1.65
0.5
2
1.25
900
534,000
91.13
215301
TAVARES
FS
12127
A
0
5
2.5
0.1
0.16
90
98
94
0
4
1.25
1.65
0.5
2
1.25
1,000
535,000
91.30
215301
TAVARES
FS
12101
A
0
5
2.5
0.1
0.27
90
98
94
0
4
1.25
1.65
0.5
2
1.25
900
535,900
91.45
215301
TAVARES
FS
12105
A
0
5
2.5
0.1
1.19
90
98
94
0
4
1.25
1.65
0.5
2
1.25
9,900
545,800
93.14
215301
TAVARES
FS
12097
A
0
5
2.5
0.1
0.02
90
98
94
0
4
1.25
1.65
0.5
2
1.25
3,000
548,800
93.65
215301
TAVARES
FS
12081
A
0
5
2.5
0.1
0.1
90
98
94
0
4
1.25
1.65
0.5
2
1.25
2,600
551,400
94.10
215301
TAVARES
FS
12027
A
0
5
2.5
0.1
1.63
90
98
94
0
4
1.25
1.65
0.5
2
1.25
1,800
553,200
94.40
215301
TAVARES
FS
12009
A
0
5
2.5
0.1
0.07
90
98
94
0
4
1.25
1.65
0.5
2
1.25
1,100
554,300
94.59
215301
TAVARES
FS
12027
A
0
5
2.5
0.1
1.37
90
98
94
0
4
1.25
1.65
0.5
2
1.25
1,700
556,000
94.88
215301
TAVARES
FS
12049
A
0
5
2.5
0.1
0.61
90
98
94
0
4
1.25
1.65
0.5
2
1.25
600
556,600
94.98
215301
TAVARES
FS
12049
A
0
5
2.5
0.1
0.61
90
98
94
0
4
1.25
1.65
0.5
2
1.25
1,500
558,100
95.24
215301
TAVARES
FS
12049
A
0
5
2.5
0.1
0.76
90
98
94
0
4
1.25
1.65
0.5
2
1.25
1,600
559,700
95.51
215305
TAVARES
S
12001
A
0
5
2.5
0.1
5.02
90
98
94
0
4
1.25
1.65
0.5
2
1.25
3,500
563,200
96.11
215305
TAVARES
S
12069
A
0
5
2.5
0.1
0.12
90
98
94
0
4
1.25
1.65
0.5
2
1.25
1,300
564,500
96.33
215298
TAVARES
FS
12027
A
0
2
1
0.1
0.01
90
98
94
0
4
1.25
1.65
0.5
2
1.25
1,700
566,200
96.62
215218
CANDLER
FS
12057
A
0
5
2.5
0.1
2.29
92
98
95
0
3
1.35
1.55
0.5
2
1.25
1,900
568,100
96.95
215218
CANDLER
FS
12105
A
0
5
2.5
0.1
0.84
92
98
95
0
3
1.35
1.55
0.5
2
1.25
9,800
577,900
98.62
215218
CANDLER
FS
12057
A
0
5
2.5
0.1
2.65
92
98
95
0
3
1.35
1.55
0.5
2
1.25
2,700
580,600
99.08
215218
CANDLER
FS
12057
A
0
5
2.5
0.1
1.86
92
98
95
0
3
1.35
1.55
0.5
2
1.25
1,500
582,100
99.33
215223
CANDLER
S
12069
A
0
5
2.5
0.1
0.43
92
98
95
0
3
1.35
1.55
0.5
2
1.25
900
583,000
99.49
215223
CANDLER
S
12097
A
0
5
2.5
0.1
0.03
92
98
95
0
3
1.35
1.55
0.5
2
1.25
3,000
586,000
100.00
| epa | 2024-06-07T20:31:43.556036 | regulations | {
"license": "Public Domain",
"url": "https://downloads.regulations.gov/EPA-HQ-OPP-2002-0249-0008/content.txt"
} |
EPA-HQ-OPP-2002-0249-0009 | Supporting & Related Material | "2002-10-01T04:00:00" | null | UNITED
STATES
ENVIRONMENTAL
PROTECTION
AGENCY
WASHINGTON,
D.
C.
20460
OFFICE
OF
PREVENTION,
PESTICIDES
AND
TOXIC
SUBSTANCES
March
13,
2002
MEMORANDUM
SUBJECT:
DIURON:
The
REVISED
HED
Chapter
of
the
Reregistration
Eligibility
Decision
Document
(
RED).
PC
Code:
035505.
Case
0046.
DP
Barcode
D281396.
FROM:
Diana
Locke
Ph
D.
and
Carol
Christensen
Risk
Assessors
Reregistration
Branch
II
Health
Effects
Division
(
7509C)
THRU:
Alan
Nielsen,
Branch
Senior
Scientist
Reregistration
Branch
II
Health
Effects
Division
(
7509C)
TO:
Margaret
Rice,
Chief
and
Richard
Dumas,
Team
Leader
Reregistration
Branch
II
Special
Review
and
Reregistration
Division
(
7508W)
The
attached
REVISED
Human
Health
Assessment
for
the
3(
3,4
dichlorophenyl)
1,1
dimethylurea
(
diuron)
RED
document
was
generated
as
part
of
Phase
2
of
the
Interim
Public
Participation
Process.
Comments
received
from
the
Registrant
during
the
Phase
I
Error
Only
review
period
have
been
incorporated
in
this
version
of
the
HED
Human
Health
Assessment
for
Diuron.
The
Health
Effects
Division's
(
HED)
chapter
reflects
the
Agency's
current
guidelines
concerning
the
retention
of
the
Food
Quality
Protection
Act
(
FQPA)
factor
and
risk
assessment.
This
chapter
includes
a
summary
of
the
product
chemistry
from
Ken
Dockter,
residue
chemistry
and
dietary
risk
assessment
from
John
Punzi,
toxicology
review
from
Yung
Yang,
occupational
and
residential
exposure
from
Renee
Sandvig
and
Christina
Jarvis,
incidence
review
from
Ruth
Allen,
drinking
water
exposures
from
Ibrahim
Abdel
Saheb
[
Environmental
Fate
and
Effects
Division
(
EFED)],
as
well
as
risk
assessment
and
characterization
from
Diana
Locke.
Carol
Christensen
incorporated
the
changes
to
the
risk
assessment
in
response
to
error
only
comments.
The
Environmental
Fate
and
Effects
Division
(
EFED)
revised
the
drinking
water
exposure
assessment
based
upon
Registrant
comments.
The
new
memorandum
entitled
"
Drinking
Water
Reassessment
for
Diuron
and
its
Degradates"
dated
March
11,
2002
has
been
incorporated
into
the
Revised
HED
Chapter
of
the
Reregistration
Eligibility
Decision
Document
(
RED)
as
appropriate.
TABLE
OF
CONTENTS
1.0
EXECUTIVE
SUMMARY
.
.
.
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1
2.0
PHYSICAL/
CHEMICAL
PROPERTIES
CHARACTERIZATION
.
.
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7
3.0
HAZARD
CHARACTERIZATION
.
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8
3.1
Hazard
Profile
.
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8
3.2
FQPA
Considerations
.
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12
3.3
Dose
Response
Assessment
.
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12
3.3.1
Acute
RfD
.
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13
3.3.2
Chronic
RfD
.
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.
13
3.3.3
Short
term
(
1
30
days)
Incidental
Oral
Exposure
.
.
.
.
.
.
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.
14
3.3.4
Intermediate
term
(
1
6
months)
Incidental
Oral
Exposure
.
.
.
.
.
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.
15
3.3.5
Dermal
Absorption
.
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.
.
15
3.3.6
Short
(
1
30
days)
and
Intermediate
term
(
1
6
months)
Dermal
Exposure
.
.
.
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.
15
3.3.7
Long
term
(
6
months
to
life
time)
Dermal
Exposure
.
.
.
.
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.
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.
.
.
15
3.3.8
Inhalation
Exposure
(
All
Durations)
.
.
.
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.
16
3.3.9
Carcinogenic
Potential
.
.
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.
.
16
3.3.9.1
Combined
Chronic
Toxicity/
Carcinogenicity
Study
in
Rats
.
.
.
.
.
.
.
.
16
3.3.9.2
Carcinogenicity
Study
in
Mice
.
.
.
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.
.
17
3.3.9.3
Classification
of
Carcinogenic
Potential
.
.
.
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.
17
3.3.10
Mutagenicity
.
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.
17
3.3.11
Mechanism
of
Carcinogenicity
.
.
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18
3.4
Endocrine
Disruption
.
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.
21
3.5
Potential
Tetrachloroazobenzene
Contamination
.
.
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.
22
4.0
EXPOSURE
ASSESSMENT
AND
CHARACTERIZATION
.
.
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.
22
4.1
Summary
of
Registered
Uses
.
.
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22
4.2
Dietary
Exposure/
Risk
Pathway
.
.
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.
24
4.2.1
Residue
Profile
.
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26
4.2.2
Acute
Dietary
.
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27
4.2.3
Chronic
Dietary
.
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27
4.2.4
Cancer
Dietary
.
.
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.
28
4.3
Water
Exposure/
Risk
Pathway
.
.
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.
28
4.4
Residential
Exposure/
Risk
Pathway
.
.
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.
32
4.4.1
Home
Uses
.
.
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32
4.4.1.1
Handler
.
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35
4.4.1.2
Postapplication
.
.
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36
4.4.2
Recreational
.
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.
37
4.4.3
Other
(
Spray
Drift;
Farm
Worker
Children,
etc.)
.
.
.
.
.
.
.
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.
37
5.0
AGGREGATE
RISK
ASSESSMENTS
AND
RISK
CHARACTERIZATIONS
.
.
.
.
.
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.
40
5.1
Acute
Risk
.
.
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41
5.2
Short
term
Risk
.
.
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.
42
5.2.1
Aggregate
Short
term
Risk
Assessment
.
.
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.
42
5.2.2
Short
term
DWLOC
Calculations
.
.
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42
5.4
Chronic
Risk
.
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44
5.4.1
Chronic
Aggregate
Risk
Assessment
.
.
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44
5.4.2
Chronic
DWLOC
Calculations
.
.
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44
5.5
Cancer
Risk
.
.
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.
46
5.5.1
Aggregate
Cancer
Risk
Assessment
.
.
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46
5.5.2
Cancer
DWLOC
Calculations
.
.
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.
46
5.5.3
Additional
Cancer
Risks
.
.
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46
6.0
CUMULATIVE
.
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48
7.0
OCCUPATIONAL
EXPOSURE
.
.
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49
7.1
Agricultural
and
Non
crop/
Utility
Uses
.
.
.
.
.
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50
7.1.1
Handler
.
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.
50
7.1.1.1
Noncancer
Exposure
and
Risk
Estimates
.
.
.
.
.
.
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.
.
52
7.1.1.2
Cancer
Exposure
and
Risk
Estimates
.
.
.
.
.
.
.
.
.
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53
7.1.2
Postapplication
Exposures
.
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53
7.1.2.1
Noncancer
Postapplication
Exposure
and
Risk
Estimates
.
.
.
.
.
.
.
.
55
7.1.2.2
Postapplication
Exposure
and
Risk
Estimates
for
Cancer
.
.
.
.
.
.
.
.
.
56
7.1.2.2.1
Private
Growers
(
10
Days
Exposure
Per
Year)
.
.
.
.
.
.
.
.
.
.
.
.
.
.
56
7.1.2.2.2
Commercial
Farm
Workers
(
30
Days
Exposure
Per
Year)
.
.
.
.
.
.
56
7.2
Mildewcide
in
Paints,
Solvents,
Adhesives,
and
Coatings
.
.
.
.
.
.
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.
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.
56
7.2.1
Occupational
Handler
Exposures/
Risks
.
.
.
.
.
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56
7.2.1.1
Noncancer
Risks
.
.
.
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58
7.2.1.1
Cancer
Risks
.
.
.
.
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58
7.2.2
Postapplication
Exposures
to
Paint
Containing
Diuron
.
.
.
.
.
.
.
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.
58
7.3
Algaecide
in
Commercial
Fish
Production
.
.
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59
7.3.1
Handlers
.
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.
59
7.3.1.1
Noncancer
Exposures/
Risks
for
Pond
Uses
.
.
.
.
.
.
.
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.
59
7.3.1.2
Cancer
Exposures/
Risks
.
.
.
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.
59
7.3.2
Occupational
Postapplication
Exposures
to
Commercial
Fish
Ponds
.
.
.
.
.
.
.
.
60
7.4
Incident
Data
.
.
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60
8.0
DATA
NEEDS/
LABEL
REQUIREMENTS
.
.
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60
ATTACHMENTS
.
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62
1
DIURON
1.0
EXECUTIVE
SUMMARY
Diuron
[
3(
3,4
Dichlorophenyl)
1,1
dimethylurea]
is
a
pre
and
post
emergent
herbicide
that
controls
a
wide
variety
of
annual
and
perennial
broad
leafed
and
grassy
weeds
on
both
crop
and
noncrop
sites.
The
mechanism
of
herbicidal
action
is
the
inhibition
of
photosynthesis.
Products
containing
diuron
are
intended
for
both
occupational
and
residential
uses.
Occupational
uses
include
agricultural
food
and
non
food
crops;
ornamental
trees,
flowers,
and
shrubs;
paints
and
coatings;
ornamental
fish
and
catfish
production;
rights
of
way
and
industrial
sites.
Residential
uses
include
ponds,
aquariums,
and
paints.
Diuron
is
formulated
as
a
technical
product
and
formulation
intermediate,
granular,
pellet/
tablet,
wettable
powder,
dry
flowable,
emulsifiable
concentrate,
flowable
concentrate,
soluble
concentrate,
and
ready
to
use
solution.
Diuron
is
applied
using
the
following
equipment:
groundboom
sprayer,
aerial
equipment,
chemigation,
rights
of
way
sprayer,
high
pressure
handwand,
low
pressure
handwand,
tractor
drawn
spreader,
granular
backpack
spreader,
push
type
spreader,
airless
sprayer,
paintbrush,
shaker
type
applicator,
backpack
sprayer,
belly
grinder,
and
by
hand.
Products
intended
for
residential
use
may
be
applied
using
a
spoon,
by
hand,
by
airless
sprayer,
or
by
paintbrush/
roller.
Application
rates
range
from
0.8
lbs
active
ingredient
(
ai)/
acre
for
corn
to
87.1
lbs
ai/
acre
for
non
crop
areas.
Diuron
has
low
acute
toxicity
(
Toxicity
Category
3
4)
by
the
oral,
dermal,
or
inhalation
exposure
routes.
Diuron
is
not
an
eye
or
skin
irritant,
and
not
a
skin
sensitizer.
The
primary
target
organs
are
the
hematopoietic
system,
the
bladder,
and
renal
pelvis.
Erythrocyte
damage
resulted
in
hemolytic
anemia
and
compensatory
hematopoiesis,
which
were
manifested
as
significantly
decreased
erythrocyte
counts,
hemoglobin
levels,
and
hematocrit,
and
increased
mean
corpuscular
volume
(
MCV),
mean
corpuscular
hemoglobin
(
MCH),
abnormal
erythrocyte
forms,
reticulocyte
counts,
and
leukocyte
count.
Consistent
observations
of
erythrocytic
regeneration
were
seen
in
chronic
toxicity
studies
in
rats,
mice
and
dogs.
Gross
pathology
findings
in
chronic
rat
and
mouse
studies
showed
increased
incidences
of
urinary
bladder
edema
and
wall
thickening
at
high
doses.
Microscopic
evaluation
showed
dose
related
increases
in
the
severity
of
epithelial
focal
hyperplasia
of
the
urinary
bladder
and
renal
pelvis
in
both
sexes.
The
available
data
did
not
reveal
any
developmental
or
reproductive
toxicity.
The
HED
Carcinogenicity
Peer
Review
Committee
(
CPRC)
characterized
diuron
as
a
"
known/
likely"
human
carcinogen
based
on
urinary
bladder
carcinomas
in
both
sexes
of
the
Wistar
rat,
kidney
carcinomas
in
the
male
rat,
and
mammary
gland
carcinomas
in
the
female
NMRI
mouse.
The
CPRC
also
recommended
a
low
dose
linear
extrapolation
model
with
a
Q1
*
of
1.91
x
10
2
(
mg/
kg/
day)
1
be
applied
to
the
animal
data
for
the
quantification
of
human
risk,
based
on
the
urinary
bladder
carcinomas
in
the
rat.
Diuron
was
not
mutagenic
in
bacteria
or
in
cultured
mammalian
cells
and
no
indication
of
DNA
damage
in
primary
rat
hepatocytes
was
observed.
There
were
marginal
statistically
significant
increases
in
cells
with
structural
aberrations
in
a
Sprague
Dawley
rat
in
vivo
bone
marrow
chromosomal
aberration
assay.
However,
the
levels
of
aberrations
were
within
historical
2
control
range
and
assessed
negative.
There
are
no
adverse
effects
attributed
to
a
single
exposure
identified
in
any
available
studies.
In
addition,
diuron
has
low
acute
toxicity
and
no
developmental
or
neurotoxic
concerns.
Therefore,
no
acute
dietary
endpoint
was
chosen
and
no
acute
dietary
risk
assessment
was
conducted.
Also,
no
systemic
toxicity
was
observed
following
repeated
dermal
dosing
up
to
1200
mg/
kg/
d.
Therefore,
no
short
or
intermediate
term
dermal
endpoints
were
chosen
either.
The
short
term
incidental
oral
and
the
inhalation
endpoints
are
based
on
decreased
maternal
body
weight
and
food
consumption
observed
in
a
rabbit
developmental
toxicity
study
[
No
Observable
Adverse
Effect
Level
(
NOAEL)
=
10
mg/
kg/
d].
The
intermediate
term
incidental
oral
and
intermediate
term
inhalation
endpoints
are
based
on
hematological
effects
observed
at
10
mg/
kg
at
6
months
in
the
chronic
rat
study.
The
NOAEL
is
1
mg/
kg/
d.
The
chronic
dietary,
and
long
term
dermal
and
inhalation
endpoints
are
based
on
hemolytic
anemia
and
compensatory
hematopoiesis
[
Lowest
Observable
Adverse
Effect
Level
(
LOAEL)
=
1.0
mg/
kg/
d].
Since
the
dose
and
endpoint
for
establishing
the
chronic
dietary
reference
Dose
(
RfD)
is
a
LOAEL
and
a
NOAEL
was
not
established,
a
total
uncertainty
factor
(
UF)
of
300
was
applied
(
UF
of
100
to
account
for
both
interspecies
extrapolation
and
intra
species
variability,
an
additional
UF
of
3
to
account
for
the
lack
of
a
NOAEL).
The
FQPA
Safety
Factor
Committee
recommended
that
the
FQPA
safety
factor
be
reduced
to
1x
since
there
is
no
indication
of
quantitative
or
qualitative
increased
susceptibility
of
rats
or
rabbits
to
in
utero
or
postnatal
exposure.
Estimated
chronic
dietary
(
food)
risk
estimates
associated
with
the
use
of
diuron
do
not
exceed
the
Agency's
level
of
concern
for
any
population
subgroup
including
the
most
highly
exposed
subgroup,
children
ages
1
6
years.
The
chronic
dietary
risk
for
children
1
6
years
of
age
is
approximately
7%
of
the
chronic
Population
Adjusted
Dose
(
cPAD
=
0.003
mg/
kg/
d)
and
approximately
3%
for
the
general
U.
S.
population.
The
chronic
exposure
analysis
utilized
field
trial
data
which
include
residues
of
the
parent
diuron
and
its
metabolites
that
are
hydrolyzable
to
3,4
dichloroaniline
(
3,4
DCA);
3,4
dichlorophenylurea
and
3(
3,4
dichlorophenyl)
1
methylurea.
The
analysis
also
included
processing
data,
where
applicable,
and
percent
crop
treated
information.
Approximately
40%
of
the
exposure
to
diuron
from
food
is
from
orange
juice
and
orange
juice
concentrate.
The
estimated
cancer
dietary
risk
associated
with
the
use
of
diuron
indicates
a
borderline
exceedance
above
1
x
10
6
and
shows
a
lifetime
risk
estimate
of
1.68
x
10
6
for
the
general
population
but,
is
not
of
concern.
Though
this
is
the
most
refined
assessment
achievable
based
on
the
available
data/
information,
it
may
also
be
considered
conservative
since
the
exposure
analysis
used
data
from
field
trials
conducted
at
the
highest
application
rates
and
some
processing
data
are
still
outstanding.
The
Agency
has
determined
that
there
are
potential
occupational
exposures
to
mixers,
loaders,
applicators
and
other
handlers
during
the
usual
use
patterns
associated
with
diuron.
Based
on
the
agricultural
and
non
crop
use
patterns,
31
major
occupational
exposure
scenarios
were
identified
and
are
expected
to
be
of
short
(
1
30
days)
and
intermediate
(
1
6
months)
term
duration.
For
these
durations,
the
Level
of
Concern
(
LOC)
or
target
Margin
of
Exposure
(
MOE)
for
occupational
workers
is
100.
MOEs
>
100
are
not
considered
to
be
of
concern.
Calculations
of
occupational
noncancer
3
risk
based
on
inhalation
exposures
during
agricultural
and
non
crop
uses
indicate
that
the
inhalation
MOEs
are
more
than
100
at
the
highest
possible
level
of
mitigation
for
all
of
the
short
term
occupational
exposure
scenarios,
except
applying
sprays
with
a
high
pressure
handwand.
Sixteen
of
the
31occupational
scenarios
were
identified
as
having
intermediate
term
durations
of
exposure.
Of
these,
none
have
a
non
cancer
risk
of
concern
for
intermediate
term
inhalation
exposure
at
the
highest
level
of
mitigation
Potential
occupational
cancer
risks
from
diuron
use
were
assessed.
Both
the
potential
inhalation
and
dermal
exposures
were
included
in
the
cancer
risk
assessment
and
a
4%
dermal
absorption
factor
(
upper
bound
estimate)
was
applied
to
dermal
exposures.
In
general,
the
Agency
is
concerned
when
occupational
cancer
risk
estimates
exceed
1
x
10
4.
The
Agency
will
seek
ways
to
mitigate
the
risks,
to
the
extent
that
it
is
practical
and
economically
feasible,
to
lower
the
risks
to
1
x
10
6
or
less.
Out
of
a
total
of
31occupational
handler
scenarios,
five
have
cancer
risks
greater
than
1
x
10
4
at
the
highest
feasible
level
of
mitigation
and
are
of
concern.
Twenty
six
of
the
occupational
handler
scenarios
have
cancer
risks
between
1
x
10
4
and
1
x
10
6
at
the
highest
feasible
level
of
mitigation.
Both
occupational
and
residential
(
see
below)
cancer
risk
assessments
are
considered
protective
based
on
conservative
exposure
assumptions
and
a
high
end
dermal
absorption
factor.
The
Agency
has
determined
that
there
are
potential
postapplication
exposures
to
workers
during
the
agricultural
and
non
crop
uses
associated
with
diuron.
However,
a
noncancer
postapplication
assessment
was
not
conducted,
since
only
dermal
exposures
are
expected
and
no
dermal
toxicity
is
expected
from
short
or
intermediate
term
exposures.
For
the
postapplication
cancer
assessment,
only
the
crops
whose
foliage
can
be
sprayed
without
damage
were
assessed
for
postapplication
exposure
to
foliage.
The
crops
that
can
be
sprayed
without
foliage
damage
are
oats,
wheat,
birdsfoot
trefoil,
clover,
grass
grown
for
seed,
alfalfa,
asparagus,
pineapple,
and
sugarcane.
Postapplication
cancer
risks
for
private
growers
(
10
days
of
exposure
per
year)
were
calculated
at
both
the
typical
application
rate
and
the
maximum
application
rates.
All
potential
cancer
risks
to
private
growers
were
estimated
to
be
less
than
1
x
10
4
on
the
day
of
treatment.
Postapplication
cancer
risks
for
commercial
applicators
(
30
days
per
year)
were
calculated
at
the
typical
application
rate
only.
All
potential
cancer
risks
to
commercial
applicators
were
less
than
1
x
10
4
on
the
day
of
treatment.
Since
diuron
is
applied
directly
to
the
soil,
there
may
also
be
significant
postapplication
exposure
to
diuron
resulting
from
contact
with
treated
soil
when
planting
seedlings,
moving
irrigation
lines,
or
other
soil
related
activities.
Occupational
risk
assessments
were
conducted
for
the
use
of
diuron
as
a
mildewcide
in
paint.
Four
occupational
handler
scenarios
were
identified
for
the
use
of
diuron
in
paint
and
are
expected
to
be
of
short
and
intermediate
term
exposure
duration.
The
calculations
of
short
and
intermediate
term
inhalation
risk
from
the
use
of
diuron
in
paint
indicate
that
MOEs
are
more
than
100
at
the
assessed
level
of
mitigation
for
all
the
exposure
scenarios,
except
applying
paints
with
an
airless
sprayer
(
indoors).
At
the
assessed
level
of
mitigation,
all
four
scenarios
have
potential
cancer
risks
between
1
x
10
4
and
1
x
10
6.
However,
it
is
likely
that
risks
are
even
lower
since
the
cancer
assessment
incorporated
a
number
of
conservative
assumptions,
such
as
maximum
application
rate
and
an
upper
bound
dermal
absorption
factor.
Occupational
postapplication
exposures
to
paint
containing
diuron
may
occur
in
industrial
settings
around
open
vats
used
in
paint
processing.
Inhalation
and
dermal
exposures
may
also
occur
while
maintaining
industrial
equipment.
No
postapplication
exposure
data
4
have
been
submitted
to
determine
the
extent
of
postapplication
exposures
in
the
industrial
settings.
Nonetheless,
inhalation
exposures
are
expected
to
be
minimal
because
of
the
low
vapor
pressure
of
diuron
(
2
x
10
7
mm
Hg
at
30
E
C)
and
aerosol
formation
is
not
expected.
Dermal
postapplication
exposures
are
expected
to
be
lower
than
when
handling/
loading
the
formulated
product.
Therefore,
postapplication
exposures
in
the
industrial
settings
are
expected
to
be
minimal
and
not
of
concern.
Occupational
risk
assessments
were
also
conducted
for
the
use
of
diuron
as
an
algaecide
in
commercial
fish
ponds.
Four
short
term
occupational
handler
scenarios
were
identified
for
the
use
of
diuron
in
commercial
fish
production
and
the
inhalation
MOEs
from
all
four
of
the
commercial
fish
production
scenarios
were
greater
than
100
at
the
baseline
level
of
mitigation
and
are
not
of
concern.
With
maximum
mitigation
measures
(
engineering
control
level),
all
four
scenarios
have
estimated
cancer
risks
of
less
than
1
x
10
6
and
are
not
of
concern.
Occupational
postapplication
exposure
to
diuron
in
treated
fish
production
ponds
is
not
likely
to
result
in
a
risk
of
concern
based
on
the
extremely
high
dilution
rate.
The
Agency
has
determined
that
there
are
potential
exposures
to
residential
mixers,
loaders,
and
applicators
during
1)
loading
ready
to
use
liquids,
2)
applying
paints/
stains
with
a
paintbrush,
and
3)
applying
paints
with
an
airless
sprayer
(
outdoor
applications
only).
Residential
exposures
to
diuron
are
expected
to
be
short
term.
For
residential
handlers,
calculations
of
noncancer
risk
indicate
that
the
inhalation
MOEs
are
more
than
100
for
all
of
the
exposure
scenarios
and
are
not
of
concern.
For
residential
populations,
cancer
risks
less
than
1
x
10
6
are
not
considered
to
be
of
concern.
All
residential
handler
scenarios
have
a
potential
cancer
risk
greater
than
1
x
10
6
and
are
of
concern,
except
for
the
loading
ready
to
use
liquids
for
ponds
and
aquariums
scenario,
which
is
not
of
concern.
The
Agency
notes
that
cancer
risk
estimates
to
residential
handlers
of
diuron
treated
paint
are
based
on
two
exposures
per
year,
which
is
considered
a
high
end
assumption.
Postapplication
inhalation
or
dermal
exposure
resulting
from
the
indoor
use
of
diuron
in
paints
is
also
expected
to
be
minimal
because
of
the
low
vapor
pressure
of
diuron,
and
because
diuron
treated
paint
is
only
likely
to
be
used
in
rooms
where
high
humidity
is
expected
(
i.
e.
a
bathroom),
and
would
rarely
be
used
in
the
entire
house.
Postapplication
inhalation
and
dermal
exposure
resulting
from
the
use
of
diuron
in
residential
ponds
and
aquariums
is
also
expected
to
be
minimal
based
on
the
extremely
high
dilution
rate.
When
potential
food
and
residential
inhalation
exposures
were
combined
for
short
term
aggregate
risk
estimates,
they
resulted
in
aggregate
short
term
MOEs
=
1043
and
1045
for
adult
males
and
females,
respectively.
Based
on
the
lack
of
systemic
toxicity
expected
by
the
dermal
route,
it
was
not
appropriate
to
combine
residential
dermal
and
inhalation
exposure
estimates
for
risk
assessment
purposes.
Based
on
labeled
uses,
no
intermediate
or
long
term
residential
handler,
or
postapplication
exposures
of
any
duration,
are
expected.
Based
on
supported
uses,
no
incidental
oral
exposures
are
expected.
Aggregate
short
term
risk
estimates
for
diuron
and
its
metabolites
hydrolyzable
to
3,4
DCA
would
combine
exposures
from
food
(
average),
water,
and
inhalation.
Since
measured
drinking
water
5
data
(
monitoring
data)
are
limited
and
cannot
be
quantitatively
included
in
the
risk
assessment,
estimates
of
allowable
levels
of
drinking
water
were
calculated
instead.
The
Agency
determined
that
it
was
unlikely
that
more
than
one
of
the
residential
handler
activities
would
occur
concurrently
during
a
shortterm
time
period.
Therefore,
the
Agency
took
the
protective
approach
of
including
the
exposures
from
the
activity
which
could
potentially
result
in
the
most
exposure
to
the
homeowner,
applying
paint
with
an
airless
sprayer,
in
the
aggregate
assessment.
The
Agency
can
conclude
with
reasonable
certainty
that
residues
of
diuron
plus
its
metabolites
hydrolyzable
to
3,4
DCA,
resulting
from
applications
of
diuron,
in
drinking
water
would
not
likely
result
in
a
short
term
aggregate
risk
to
male
and
female
adult
homeowners
above
the
Agency's
level
of
concern.
Aggregate
chronic
(
noncancer)
risk
estimates
include
the
contribution
of
risk
from
dietary
sources
(
food
+
water)
and
residential
sources.
However,
based
on
the
labeled
uses,
no
long
term
or
chronic
residential
exposures
are
expected.
Chronic
risk
estimates
from
exposures
to
food
alone,
do
not
exceed
the
Agency's
level
of
concern.
However,
the
Agency
cannot
conclude
with
reasonable
certainty
that
residues
of
diuron,
plus
its
metabolites
hydrolyzable
to
3,4
DCA,
in
drinking
water
would
not
likely
result
in
an
aggregate
chronic
risk
to
infants,
children,
or
adults
above
the
Agency's
level
of
concern.
The
Agency
based
this
determination
on
a
comparison
of
estimated
concentrations
of
diuron
and
its
metabolites
in
surface
waters
to
back
calculated
"
drinking
water
levels
of
comparison"
(
DWLOCs)
for
diuron
plus
its
metabolites.
The
estimated
ground
water
concentrations
are
not
expected
to
exceed
the
DWLOCs.
Estimated
exposure
to
food
alone
results
in
a
cancer
risk
for
the
U.
S.
general
population
that
is
not
of
concern.
However,
residential
exposures
to
applicators
applying
paint
with
a
paintbrush
or
airless
sprayer
may
result
in
potential
cancer
risks
that
are
of
concern.
Since
potential
cancer
risks
from
exposures
during
residential
activities,
alone,
are
of
concern,
no
aggregate
cancer
risk
and
no
DWLOCs
were
calculated.
Any
potential
additional
exposure
to
residues
in
water
are
of
concern.
The
Metabolism
Assessment
Review
Committee
(
MARC)
recommended
that
a
separate
dietary
cancer
assessment
be
conducted
for
N'(
3
chlorophenyl)
N,
N
dimethyl
urea
(
MCPDMU),
a
potential
residue
of
concern
in
drinking
water,
but
not
found
in
food
(
in
plant
or
animal
metabolism
studies).
The
MARC
raised
concerns
for
MCPDMU
based
on
an
analogous
compound,
N'(
4
chlorophenyl)
N,
N
dimethyl
urea
(
monuron).
With
the
exception
of
the
position
of
the
chlorine,
the
structures
are
identical.
There
are
cancer
concerns
for
monuron
but
the
target
organs
are
different
than
those
affected
by
diuron.
In
the
absence
of
the
data
needed
for
a
more
comprehensive
evaluation
of
MCPDMU,
the
carcinogenic
risk
assessment
was
conducted
using
the
Q1
*
of
monuron
[
1.52
x
10
2
(
mg/
kg/
day)
1]
that
is
based
on
male
rat
liver
neoplastic
nodule
and/
or
carcinoma
combined
tumor
rates.
The
calculated
potential
cancer
risk
to
the
U.
S.
general
population
from
exposure
to
MCPDMU
in
catfish
is
1.02
x
10
7
and
is
not
of
concern.
However,
the
estimated
concentration
of
MCPDMU
in
surface
water
exceeds
the
DWLOC
and
is
of
concern.
In
summary,
diuron
has
low
acute
toxicity
and
no
systemic
toxicity
was
observed
following
6
repeated
dermal
dosing.
!
The
potential
dietary
risks,
based
on
food
alone,
are
not
of
concern.
However,
the
estimated
chronic
surface
water
concentrations
exceed
the
DWLOCs.
!
The
aggregate
short
term
risk
(
food
+
water
+
residential)
is
not
of
concern.
!
Occupational
noncancer
risks
based
on
inhalation
exposures
during
agricultural
and
non
crop
uses
are
not
of
concern
at
the
highest
possible
level
of
mitigation
for
all
of
the
short
term
occupational
exposure
scenarios,
except
applying
sprays
with
a
high
pressure
handwand.
Intermediate
term
handler
risks
from
agricultural
and
non
crop
uses
are
not
of
concern
at
the
highest
possible
level
of
mitigation
for
all
assessed
exposure
scenarios.
Out
of
a
total
of
31
agricultural
and
non
crop
occupational
handler
scenarios,
five
have
potential
cancer
risks
greater
than
1
x
10
4
at
the
highest
feasible
level
of
mitigation
and
are
of
concern,
and
26
have
cancer
risks
between
1
x
10
4
and
1
x
10
6
at
the
highest
feasible
level
of
mitigation.
Though
there
are
potential
postapplication
exposures
to
workers
during
the
agricultural
and
non
crop
uses
associated
with
diuron,
a
noncancer
postapplication
assessment
was
not
conducted,
since
no
dermal
toxicity
is
expected
from
short
or
intermediate
term
exposures.
All
potential
postapplication
cancer
risks
to
private
growers
and
commercial
applicators
were
estimated
to
be
less
than
1
x
10
4
on
the
day
of
treatment.
!
Occupational
risk
assessments
were
also
conducted
for
the
use
of
diuron
as
a
mildewcide
in
paint.
With
mitigation,
there
are
no
concerns
for
noncancer
risks
to
occupational
handlers
exposed
to
paints
containing
diuron,
except
for
intermediate
term
inhalation
risks
from
applying
paints
with
an
airless
sprayer
(
indoors).
With
mitigation,
all
occupational
mildewcide
scenarios
have
potential
cancer
risks
between
1
x
10
4
and
1
x
10
6.
Postapplication
exposures
are
expected
to
be
minimal.
!
The
occupational
handler
scenarios
identified
for
the
use
of
diuron
in
commercial
fish
production
have
estimated
noncancer
risks
that
are
not
of
concern
at
the
baseline
level
of
mitigation.
With
maximum
mitigation
measures,
all
the
fish
production
scenarios
have
estimated
cancer
risks
of
less
than
1
x
10
6
and
are
not
of
concern.
Postapplication
exposures
to
diuron
in
treated
fish
production
ponds
is
minimal
and
not
of
concern.
!
For
residential
handlers
exposed
during
paint
and,
pond
and
aquarium
uses,
the
noncancer
risks
are
not
of
concern
but,
potential
cancer
risks
are
greater
than
1
x
10
6
and
are
of
concern,
except
for
the
loading
ready
to
use
liquids
for
ponds
and
aquariums
scenario,
which
is
not
of
concern.
Postapplication
inhalation
and
dermal
exposure
resulting
from
the
use
of
diuron
in
ponds
and
aquariums,
and
from
the
indoor
use
of
diuron
in
paints,
is
expected
to
be
minimal.
7
2.0
PHYSICAL/
CHEMICAL
PROPERTIES
CHARACTERIZATION
Diuron
[
3(
3,4
dichlorophenyl)
1,1
dimethylurea]
Empirical
formula:
C9H10Cl
2N2O
Molecular
weight:
233.1
CAS
Registry
No.:
330
54
1
PC
Code:
035505
NH
N
CH
3
CH3
O
Cl
Cl
The
product
chemistry
data
base
is
not
complete;
new
confidential
statement
of
formula
(
CSF)
data
are
required
which
reflect
preliminary
analyses
of
current
products
together
with
discussions
of
formation
of
impurities.
Trace
amounts
of
a
manufacturing
impurity,
tetrachloro
azobenzene
(
TCAB),
that
are
of
toxicological
concern,
may
be
present
(
see
Section
3.5).
The
available
Generic
Series
830
physical
and
chemical
properties
of
diuron
are
given
below
(
Diuron.
List
A
Reregistration
Case
0046.
PC
Code
035505.
Product
Chemistry
Chapter
for
the
Reregistration
Eligibility
Decision
[
RED]
Document.
DP
Barcode
D274489.
Ken
Dockter.
June
26,
2001).
Table
1.
Generic
Series
830
Physical
and
Chemical
Properties
GLN
MRID
Data
6302
Color
1
White
6303
Physical
state
1
Crystal
6304
Odor
1
None
7200
MP
1
158o
C
7840
Water
solubility
1
42
ppm
@
25o
C
7950
vp
1
2
x
10
7
mm
Hg
@
30o
C
7550
Log
Pow
2
2.68
6320
Corrosion
characteristics
43842201
Not
corrosive
8
6313
Stability
to
normal
and
elevated
temperatures,
metals,
and
metal
ions
43842201
Stable
for
2
yrs.
in
double
polyethylene
bag
inside
a
fiber
drum
under
warehouse
conditions.
Metals
and
metal
ion
data
not
given.
7050
UV/
Visible
absorption
NG
NG:
Not
Given.
1
Diuron.
CASRN:
330
54
1.
http://
toxnet.
nlm.
nih.
gov/
egi
bin/
sis/
search.
2
Reddy,
K.
N.
and
M.
A.
Locke.
1996.
Molecular
Properties
as
Descriptors
of
Octanol
Water
Partition
Coefficients
of
Herbicides.
Water,
Air
and
Soil
Pollution
Vol.
86:
pp
389
405.
3.0
HAZARD
CHARACTERIZATION
3.1
Hazard
Profile
Diuron
is
a
substituted
urea
herbicide
for
the
control
of
a
wide
variety
of
annual
and
perennial
broad
leaved
and
grassy
weeds
on
both
crop
and
non
crop
sites.
The
mechanism
of
herbicidal
action
is
the
inhibition
of
photosynthesis.
Diuron
has
a
low
acute
toxicity
(
Toxicity
Category
3
or
4)
by
the
oral,
dermal,
or
inhalation
exposure
routes.
Diuron
is
not
an
eye
or
skin
irritant,
and
not
a
skin
sensitizer.
A
rat
metabolism
study
indicated
that
diuron
is
rapidly
absorbed
and
metabolized
within
24
hours
post
dose
at
the
low
dose
and
within
48
hours
post
dose
at
the
high
dose.
The
urine
is
the
major
route
of
excretion
in
both
sexes.
A
small
amount
of
diuron
is
detected
in
the
feces.
The
highest
tissue
residue
levels
were
found
in
the
liver
and
kidneys
4
days
post
14C
diuron
dose.
The
metabolism
of
diuron
involved
N
oxidation,
some
ring
hydroxylation,
demethylation,
dechlorination,
and
conjugation
to
sulfate
and
glucuronic
acid
(
Diuron
Toxicology
Disciplinary
Chapter
for
the
Reregistration
Eligibility
Decision.
Yung
Yang.
0ctober
2,
2001).
The
primary
diuron
target
organs
are
the
hematopoietic
system,
bladder,
and
renal
pelvis.
Erythrocyte
damage
resulted
in
hemolytic
anemia
and
compensatory
hematopoiesis,
which
are
manifested
as
significantly
decreased
erythrocyte
counts,
hemoglobin
levels,
and
hematocrit,
and
increased
mean
corpuscular
volume
(
MCV),
mean
corpuscular
hemoglobin
(
MCH),
abnormal
erythrocyte
forms,
reticulocyte
counts,
and
leukocyte
count.
Consistent
observations
of
erythocytic
regeneration
are
seen
in
chronic
toxicity
studies
in
rats,
mice
and
dogs.
Gross
pathology
findings
in
chronic
rat
and
mouse
studies
showed
increased
incidences
of
urinary
bladder
edema
and
wall
thickening
at
high
doses.
Microscopic
evaluation
showed
dose
related
increases
in
the
severity
of
epithelial
focal
hyperplasia
of
the
urinary
bladder
and
renal
pelvis
in
both
sexes.
9
Although
the
developmental
toxicity
study
in
rats
is
classified
as
unacceptable,
the
data
base
as
a
whole
is
adequate
for
pre
and
post
natal
toxicity
evaluation
and
did
not
reveal
developmental
or
reproductive
toxicity.
The
NOAELs
for
maternal/
parental
toxicity
were
either
less
than
or
equal
to
the
NOAELs
for
fetal
or
reproductive
toxicity.
The
HED
Carcinogenicity
Peer
Review
Committee
(
CPRC)
characterized
diuron
as
a
"
known/
likely"
human
carcinogen,
based
on
urinary
bladder
carcinomas
in
both
sexes
of
the
Wistar
rat,
kidney
carcinomas
in
the
male
rat
(
a
rare
tumor),
and
mammary
gland
carcinomas
in
the
female
NMRI
mouse.
The
CPRC
also
recommended
a
low
dose
linear
extrapolation
model
with
a
Q1
*
of
1.91
x
10
2
(
mg/
kg/
day)
1
be
applied
to
the
animal
data
for
the
quantification
of
human
risk,
based
on
the
urinary
bladder
carcinomas
in
the
rat.
Diuron
was
not
mutagenic
in
bacteria
or
in
cultured
mammalian
cells
and
no
indication
of
DNA
damage
in
primary
rat
hepatocytes
was
observed.
There
were
marginal
statistically
significant
increases
in
cells
with
structural
aberrations
in
a
Sprague
Dawley
rat
in
vivo
bone
marrow
chromosomal
aberration
assay.
However,
the
levels
of
aberrations
were
within
the
historical
control
range
and
assessed
negative.
The
Hazard
Identification
Assessment
Review
Committee
(
HIARC)
determined
that
a
28
day
inhalation
study
is
required
to
address
the
concern
for
inhalation
exposure
potential
based
on
the
use
pattern.
The
registrant
can
follow
the
90
day
inhalation
study
protocol
but
cease
exposure
at
28
days.
The
HIARC
also
determined
that
a
repeated
chronic
dog
study
is
not
required;
a
new
study
would
not
provide
additional
data
since
the
observed
effects
are
similar
in
the
rat
and
the
rat
is
the
more
sensitive
species
for
this
chemical.
Table
2.
Acute
Toxicity
of
Diuron
Guideline
No.
Study
Type
MRID
#
Results
Toxicity
Category
870.1100
Acute
Oral
00146144
LD50
=
4721
mg/
kg
(
M)
>
5000
mg/
kg
(
F)
III
870.1200
Acute
Dermal
00146146
LD50
>
2000
mg/
kg
III
870.1300
Acute
Inhalation
40228803
LC50
>
7.1
mg/
L
IV
870.2400
Primary
Eye
Irritation
00146147
At
48
hrs,
all
irritation
had
cleared.
III
870.2500
Primary
Skin
Irritation
00146148
All
irritation
had
cleared
by
72
hrs.
IV
870.2600
Dermal
Sensitization
00146149
Nonsensitizer
N/
A
870.6200
Acute
Neurotoxicity
N/
A
Not
available
N/
A
10
Table
3.
Subchronic,
Chronic
and
Other
Toxicity
Guideline
#/
Study
Type
MRID
#
(
year)/
Classification/
Doses
Results
870.3100
90
Day
oral
toxicity
in
rats
MRID
40886502
(
1988)
Acceptable/
Nonguideline
0,
4,
10,
or
25
ppm
(
0,
0.3,
0.7,
or
1.6
mg/
kg/
day
for
males
and
0,
0.3,
0.8,
1.8
mg/
kg/
day
for
females)
The
NOAEL
can
not
be
determined
based
on
equivocal
findings
in
the
urinary
bladder
including
blood
vessel
dilation,
reduced
transparency,
and
increased
firmness.
870.3200
21/
28
Day
dermal
toxicity
in
rabbits
MRID
42718301
(
1992)
Acceptable/
Guideline
0,
50,
500,
or
1200
mg/
kg/
day
Systemic
toxicity
NOAEL
=
1200
mg/
kg/
day
(
HDT)
870.3465
90
Day
inhalation
toxicity
Not
available
Not
available
870.3700a
Prenatal
developmental
toxicity
in
rats
MRID
40228801
(
1986)
Unacceptable/
Guideline
0,
16,
80,
or
400
mg/
kg/
day
Maternal
toxicity
NOAEL
=
16
mg/
kg/
day.
Maternal
toxicity
LOAEL
=
80
mg/
kg/
day,
based
on
decreased
body
weight
gain
and
food
consumption.
Developmental
toxicity
NOAEL=
80
mg/
kg/
day.
Developmental
toxicity
LOAEL
=
400
mg/
kg/
day,
based
on
whole
litter
resorption,
reduced
fetal
body
weights,
and
delayed
ossification
of
the
vertebrae
and
sternebrae.
870.3700b
Prenatal
developmental
toxicity
in
rabbits
MRID
40228802
(
1986)
Acceptable/
Guideline
0,
2,
10,
or
50
mg/
kg/
day
Maternal
toxicity
NOAEL
=
10
mg/
kg/
day.
Maternal
toxicity
LOAEL
=
50
mg/
kg/
day,
based
on
decreased
body
weight
and
food
consumption.
Developmental
toxicity
NOAEL
=
50
mg/
kg/
day
(
HDT).
870.3800
Reproduction
and
fertility
effects
in
rats
MRID
41957301
(
1990)
Acceptable/
Guideline
0,
10,
250,
or
1750
ppm.
(
0,
0.58,
14.8,
or
101
mg/
kg/
day
for
males
and
0,
0.71,
18.6,
or
132
mg/
kg/
day
for
females,
respectively.
Parental
NOAEL
=
250
ppm
(
18.6
mg/
kg/
day).
Parental
LOAEL
=
1750
ppm
(
132
mg/
kg/
day)
based
on
decreased
body
weight,
body
weight
gain,
food
consumption
and
food
efficiency
in
both
generations.
Reproductive
NOAEL
=
1750
ppm
(
HDT).
Offspring
NOAEL
=
250
ppm
(
18.6
mg/
kg/
day).
Offspring
LOAEL
=
1750
ppm
(
132
mg/
kg/
day)
based
on
decreased
body
weight
of
the
F1
and
F2
pups
during
lactation.
870.4200b
Chronic
toxicity
in
dogs
MRID
00091192
(
1964)
Unacceptable/
Guideline
0,
25,
125,
250,
or
2500/
1250
ppm
(
0,
1.8,
9.4,
18.8,
or
93.8
mg/
kg/
day
by
conversion
factor
of
0.075)
for
24
months.
NOAEL
=
125
ppm
(
9.4
mg/
kg/
day)
in
males
and
250
ppm
(
18.8
mg/
kg/
day)
for
females.
LOAEL
=
250
ppm
(
18.8
mg/
kg/
day)
for
males
and
1250
ppm
(
93.8
mg/
kg/
day)
for
females
based
on
anemia
and
body
weight
losses.
Guideline
#/
Study
Type
MRID
#
(
year)/
Classification/
Doses
Results
11
870.4300
Combined
Chronic/
Carcinogenicity
in
rats
MRID
40886501,43871901,
43804501,
44302003
(
1986)
Acceptable/
Guideline
0,
25,
250,
2500
ppm
(
0,
1.0,
10,
or
111
mg/
kg/
day
for
males
and
0,
1.7,
17,
or
203
mg/
kg/
day
for
females)
for
24
months.
NOAEL
=
Not
established.
LOAEL
=
25
ppm
(
1.0
mg/
kg/
day
for
males
and
1.7
mg/
kg/
day
for
females)
based
on
evidence
of
hemolysis
and
compensatory
hematopoiesis
(
decreased
erythrocyte
counts,
increased
reticulocyte
counts,
increased
spleen
weight
and
bone
marrow
activation).
Dosing
was
considered
adequate.
870.4300
Carcinogenicity
in
mice
MRID
42159501
(
1983)
Acceptable/
Guideline
0,
25,
250,
or
2500
ppm
(
0,
5.4,
50.8,
or
640.13
mg/
kg/
day
for
males
and
0,
7.5,
77.5,
or
867.0
mg/
kg/
day
for
females)
for
24
months
NOAEL
=
250
ppm
(
50.8
and
77.5
mg/
kg/
day)
for
males
and
females.
LOAEL
=
2500
ppm
(
640.1
and
867.0
mg/
kg/
day)
for
males
and
females
based
on
hemolytic
anemia
and
liver
toxicity
in
both
sexes
and
urinary
bladder
toxicity
in
females.
Dosing
was
considered
adequate.
870.5100
Gene
mutation
Salmonella
typhimurium
reverse
gene
mutation
MRID
00146608
(
1985),
40228805
(
1991)
Acceptable/
Guideline
Independent
trials
were
negative
in
S.
typhimurium
strains
TA1535,
TA97,
TA98
and
TA100
up
to
the
highest
doses
tested
(
10
µ
g/
plate
S9;
250
µ
g/
plate
+
S9);
higher
concentrations
(
$
50
µ
g/
plate
S9;
500
µ
g/
plate
+
S9)
were
cytotoxic.
870.5300
Gene
mutation
Chinese
hamster
ovary
(
CHO)/
HGPRT
cell
forward
gene
mutation
assay
MRID
00146609
(
1985)
Acceptable/
Guideline
Independent
tests
were
negative
up
to
cytotoxic
doses
without
S9
activation
(
1.250
mM,
.
291
µ
g/
mL)
and
with
S9
activation
(
0.5
mM
.
117
µ
g/
mL).
870.5375
Chromosomal
aberration
in
vivo
rat
bone
marrow
cytogenetic
assay
MRID00146611
(
1985)
MRID
44350301
(
1997)
(
revised)
Acceptable/
Guideline
The
test
was
negative
in
Sprague
Dawley
rats
up
to
cytotoxic
doses.
A
significant
(
p<
0.05)
increase
in
the
percentage
of
abnormal
cells
and
the
average
number
of
aberrations
per
cell
was
seen
but
only
when
the
data
were
combined
for
the
high
and
mid
dose
males
and
females
at
the
48
hour
sampling
time.
A
significant
positive
linear
trend
was
also
recorded
for
the
combined
(
by
sex)
aberrations
per
cell
and
percentage
abnormal
cells.
Nevertheless,
the
values
fell
well
within
the
range
of
historical
control
ranges.
870.5375
Mouse
Bone
Marrow
Micronucleus
MRID
45494502
(
1995)
80%
ai,
45494503
(
1995)
42.4%
ai,
45494504
(
1996)
80%
ai,
45494505
(
1998)
98.1%
ai
Acceptable/
Guideline
Preliminary
review
indicates
no
evidence
of
cytogenetic
effect
in
mice
administered
either
technical
grade
or
formulated
diuron.
870.5550
Unscheduled
DNA
Synthesis
MRID
00146610
(
1985)
Acceptable/
Guideline
The
test
was
negative
up
to
cytotoxic
doses
(
$
0.33
mM,
equivalent
to
.
76
F
g/
mL).
Guideline
#/
Study
Type
MRID
#
(
year)/
Classification/
Doses
Results
12
870.7485
Metabolism
and
pharmacokinetics
MRID
42010501
(
1996)
Acceptable/
Guideline
Diuron
was
rapidly
absorbed,
metabolized
and
excreted.
Urine
was
the
major
route
of
excretion.
Metabolism
of
diuron
involved
Noxidation
ring
hydroxylation,
demethylation,
dechlorination,
and
conjugation
to
sulfate
and
glucuronic
acid.
870.7600
Dermal
penetration
Not
available
for
diuron.
Not
available.
3.2
FQPA
Considerations
There
is
an
acceptable
developmental
toxicity
study
in
rabbits
and
an
acceptable
two
generation
reproduction
study
in
rats.
A
developmental
toxicity
study
in
rats
was
classified
as
unacceptable
due
to
deficiencies
in
analytical
data
on
the
sample
analysis;
however,
the
HIARC
considered
the
developmental
toxicity
study
in
rats
adequate
for
the
FQPA
susceptibility
assessment
based
on
the
observation
that
the
developmental
toxicity
NOAEL
was
higher
than
the
maternal
NOAEL.
The
HIARC
concluded
that
a
developmental
neurotoxicity
(
DNT)
study
is
not
required.
There
is
no
indication
of
increased
susceptibility
to
young
exposed
to
diuron
in
the
available
studies.
In
the
developmental
toxicity
study
in
rabbits,
there
were
no
developmental
effects
at
the
highest
dose
tested.
In
the
developmental
toxicity
study
in
rabbits
and
in
the
2
generation
rat
reproduction
study,
developmental/
offspring
effects
were
observed
only
at
maternally/
parentally
toxic
dose
levels.
No
acute
or
subchronic
neurotoxicity
study
is
available.
However,
there
are
no
neurotoxic
signs
in
any
of
the
submitted
subchronic
or
chronic
studies
and
a
literature
search
did
not
reveal
any
studies
relevant
for
assessing
the
potential
neurotoxicity
of
diuron.
The
FQPA
Safety
Factor
Committee
concluded
that
the
safety
factor
could
be
removed
(
1x)
for
diuron
because
(
DIURON
Report
of
the
FQPA
Safety
Factor
Committee.
Brenda
Tarplee.
August
7,
2001):
g)
There
is
no
indication
of
quantitative
or
qualitative
increased
susceptibility
of
rats
or
rabbits
to
in
utero
or
postnatal
exposure;
h)
A
DNT
study
with
diuron
is
not
required;
and
i)
The
dietary
(
food
and
drinking
water)
and
non
dietary
(
residential)
exposure
assessments
will
not
underestimate
the
potential
exposures
for
infants
and
children.
3.3
Dose
Response
Assessment
13
Diuron
has
low
acute
toxicity
and
no
developmental
or
neurotoxic
concerns.
Since
no
adverse
effects
attributable
to
a
single
exposure
were
identified
in
available
studies,
no
acute
dietary
endpoint
was
chosen.
Also,
no
systemic
toxicity
was
observed
following
repeated
dermal
dosing
up
to
1200
mg/
kg/
d.
Therefore,
no
short
or
intermediate
term
dermal
endpoints
were
chosen
either.
The
shortterm
incidental
oral
and
the
inhalation
endpoints
are
based
on
maternal
decreased
body
weight
and
food
consumption
observed
in
a
rabbit
developmental
toxicity
study.
The
chronic
dietary,
intermediate
term
inhalation,
and
long
term
dermal
and
inhalation
endpoints
are
based
on
hemolytic
anemia
and
compensatory
hematopoiesis
(
DIURON:
2nd
Report
of
the
Hazard
Identification
Assessment
Review
Committee.
Yung
Yang.
August
28,
2001).
3.3.1
Acute
RfD
None
selected.
No
adverse
effects
attributed
to
a
single
exposure
(
dose)
were
identified
including
in
the
rat
or
rabbit
developmental
toxicity
studies.
3.3.2
Chronic
RfD
The
study
selected
was
an
acceptable/
guideline
chronic
toxicity/
oncogenicity
study
(
MRID
40886501;
supplemental
MRIDs
43871901,
43804501,
and
44302003),
in
which
diuron
(
98.7%
a.
i)
was
administered
to
groups
of
60
male
and
60
female
Wistar
rats
at
dietary
concentrations
of
0,
25,
250,
or
2500
ppm
(
0,
1.0,
10,
or
111
mg/
kg/
d,
respectively,
for
males
and
0,
1.7,
17,
or
203
mg/
kg/
d
for
females,
respectively)
for
up
to
24
months.
At
12
months,
10
animals/
sex/
group
were
sacrificed
for
interim
evaluation.
Treatment
with
diuron
did
not
affect
the
survival
of
rats.
The
only
reported
treatment
related
clinical
sign
was
reddish
discolored
or
bloody
urine
in
some
high
dose
males.
A
significant
decrease
in
body
weight
and
body
weight
gain
was
seen
in
both
sexes
of
high
dose
rats
throughout
the
study.
Diuron
affected
the
hematopoietic
system
resulting
in
hemolytic
anemia
and
compensatory
hematopoiesis,
which
were
manifested
as
significantly
decreased
erythrocyte
counts,
hemoglobin
levels,
and
hematocrit
and
increased
MCV,
MCH,
abnormal
erythrocyte
forms,
reticulocyte
counts,
and
leukocyte
counts.
See
Diuron
Toxicology
Disciplinary
Chapter
for
the
Reregistration
Eligibility
Decision.
Yung
Yang.
October
2,
2001.
Gross
pathology
showed
that
the
incidence
of
urinary
bladder
wall
thickening
was
elevated
at
24
months
for
low
and
high
dose
males
and
high
dose
females
(
p<
0.05
or
0.01).
Microscopic
evaluation
showed
that
epithelial
focal
hyperplasia
of
the
urinary
tract
and
renal
pelvis
increased
in
severity
in
both
sexes
at
12
and/
or
24
months,
and
increased
in
incidence
in
highdose
males
at
12
months
and
in
high
dose
females
at
12
and/
or
24
months
with
mid
dose
females
showing
an
increased
incidence
at
24
months.
Some
gross
and/
or
microscopic
changes
were
also
seen
in
the
liver
(
increased
weight,
swelling,
discoloration,
vacuolar
cell
degeneration,
round
cell
infiltration,
hyperemia),
although
these
effects
were
not
clearly
primary
effects
of
treatment.
The
dose
and
endpoint
for
establishing
the
chronic
RfD
is
the
LOAEL
=
1.0
mg/
kg/
day
based
on
14
Chronic
RfD
=
1.0
(
LOAEL)
mg/
kg/
day
=
0.003
mg/
kg/
day
300
(
UF)
evidence
of
hemolytic
anemia
and
compensatory
hematopoiesis
(
decreased
erythrocyte
count,
increased
reticulocyte
counts,
increased
spleen
weight
and
bone
marrow
activation).
A
NOAEL
was
not
established.
A
total
UF
of
300
was
applied
(
UF
of
100
to
account
for
both
interspecies
extrapolation
and
intra
species
variability,
an
additional
UF
of
3
to
account
for
the
lack
of
a
NOAEL).
3.3.3
Short
term
(
1
30
days)
Incidental
Oral
Exposure
The
study
selected
was
an
acceptable/
guideline
developmental
toxicity
study
in
rabbits
(
MRID#
40228802).
In
the
developmental
toxicity
study,
24
25
artificially
inseminated
New
Zealand
white
rabbits
per
group
were
administered
0,
2,
10,
or
50
mg/
kg/
day
of
Diuron
(
99%
a.
i.)
by
gavage
on
gestation
days
(
GD)
7
19,
inclusive.
On
GD
29,
all
surviving
does
were
sacrificed
and
examined
grossly.
One
control
animal
died
on
GD
0
due
to
an
anaphylactic
shock
reaction
during
insemination
and
one
high
dose
doe
aborted
and
was
killed
on
GD
26.
These
deaths
were
considered
unrelated
to
treatment.
All
remaining
animals
survived
to
scheduled
termination.
No
treatment
related
clinical
signs
of
toxicity
were
observed
in
any
animal.
Maternal
liver
weights
were
comparable
between
the
treated
and
control
groups
and
gross
necropsy
was
unremarkable.
Maternal
body
weights,
body
weight
gains,
and
food
consumption
for
the
low
and
mid
dose
groups
were
similar
to
the
control
levels
throughout
the
study.
Absolute
body
weights
of
the
high
dose
does
were
significantly
less
than
the
controls
on
GD
20.
Mean
body
weight
gains
by
the
high
dose
group
were
significantly
reduced
as
compared
with
the
controls
during
the
intervals
of
GD
10
13,
13
16,
and
7
20
(
weight
loss).
Weight
gain
by
the
high
dose
group
was
significantly
greater
than
the
controls
during
the
post
dosing
interval.
Food
consumption
by
the
high
dose
group
was
significantly
less
than
the
controls
during
the
GD
13
16,
16
20
and
7
20
intervals.
The
maternal
toxicity
LOAEL
was
established
at
50
mg/
kg/
day
based
on
decreased
body
weights
and
food
consumption
during
the
dosing
interval.
The
maternal
toxicity
NOAEL
was
established
at
10
mg/
kg/
day.
At
cesarean
section,
the
pregnancy
rates,
numbers
of
corpora
lutea,
implantation
sites,
resorptions,
and
live
fetuses,
and
fetal
body
weights
were
similar
between
the
treated
and
control
groups.
No
doseor
treatment
related
external,
visceral,
or
skeletal
malformations/
variations
were
observed
in
any
fetus.
Therefore,
the
developmental
toxicity
NOAEL
is
$
50
mg/
kg/
day
and
the
developmental
toxicity
LOAEL
is
not
identified.
The
dose
and
endpoint
selected
for
risk
assessment
is
10
mg/
kg/
day
(
NOAEL)
based
on
maternal
toxicity
(
decreased
body
weights
and
food
consumption
during
the
dosing
interval)
at
50
mg/
kg/
day
(
LOAEL).
An
UF
of
100
to
account
for
both
interspecies
extrapolation
and
intra
species
variability
was
applied
and,
since
the
FQPA
safety
factor
was
reduced
to
1x,
the
LOC
is
100
and
the
calculated
15
MOEs
must
be
100
or
above.
NOTE:
This
study
was
previously
classified
as
unacceptable/
upgradable
based
on
deficiencies
in
analytical
data
of
sample
analysis.
However,
the
HIARC
determined
that
this
study
is
acceptable
because
the
low
nominal
level
of
sample
concentration
was
observed
at
the
low
dose
only
and
the
NOAEL
was
established
at
the
mid
dose
with
the
LOAEL
at
the
high
dose.
Therefore,
the
deficiencies
in
the
analytical
data
did
not
affect
the
results
of
the
study.
The
systemic
toxicity
(
expressed
as
maternal
toxicity)
is
relevant
for
the
populations
(
infants
and
children)
and
duration
(
1
30
days)
of
concern.
Short
term
incidental
oral
LOC
=
100
3.3.4
Intermediate
term
(
1
6
months)
Incidental
Oral
Exposure
The
study
selected
was
the
chronic
toxicity/
carcinogenicity
study
in
rats
(
MRID#
40886501,
43871901,
43804501,
44302003).
See
Chronic
RfD,
section
3.3.2.
The
dose
and
endpoint
for
risk
assessment
was
a
NOAEL
of
1.0
mg/
kg/
day
based
on
hematological
effects
observed
at
10
mg/
kg/
day
(
LOAEL)
at
the
6th
month
observation.
It
is
noted
that
this
NOAEL/
LOAEL
is
different
from
the
24th
month
observation
where
the
NOAEL
is
not
established
(
LOAEL=
1.0
mg/
kg/
day).
The
endpoint
observed
at
the
6th
month
observation
period
is
appropriate
for
this
exposure
duration
and
is
relevant
for
the
population
of
concern.
A
UF
of
100
and
the
FQPA
safety
factor
of
1x
were
applied
to
the
risk
assessment;
therefore
the
LOC
=
100
and
the
calculated
MOEs
must
be
100
or
above.
Intermediate
term
incidental
oral
LOC
=
100
3.3.5
Dermal
Absorption
No
dermal
absorption
study
is
available.
An
upper
bound
estimation
of
dermal
absorption
of
4%
was
extrapolated
using
the
maternal
LOAEL
of
50
mg/
kg/
day
from
the
oral
developmental
toxicity
study
in
the
rabbit
and
the
NOAEL
of
1200
mg/
kg/
day
(
HDT)
from
the
21
day
dermal
toxicity
study
in
the
rabbit:
the
ratio
is
50/
1200
or
4%.
Dermal
absorption
factor
=
4%
3.3.6
Short
(
1
30
days)
and
Intermediate
term
(
1
6
months)
Dermal
Exposure
None
selected.
No
systemic
toxicity
was
seen
following
repeated
dermal
dosing
at
1200
mg/
kg/
day
in
the
rabbit
dermal
toxicity
study.
Also,
there
is
no
developmental
toxicity
concern.
No
hazard
was
identified
and
no
quantitative
assessment
is
required.
16
3.3.7
Long
term
(
6
months
to
life
time)
Dermal
Exposure
The
study
selected
was
the
chronic
toxicity/
carcinogenicity
study
in
rats
(
MRID#
40886501,
43871901,
43804501,
44302003).
See
Chronic
RfD,
section
3.3.2.
The
dose
and
endpoint
selected
for
risk
assessment
was
1.0
mg/
kg/
day
(
LOAEL)
based
on
evidence
of
hemolytic
anemia
and
compensatory
hematopoiesis
(
decreased
erythrocyte
count,
increased
reticulocyte
counts,
increased
spleen
weight
and
bone
marrow
activation).
A
NOAEL
was
not
established.
An
additional
UF
of
3
is
applied
to
account
for
the
lack
of
a
NOAEL
in
this
study.
Therefore,
the
LOC
=
300.
An
MOE
<
300
with
a
dermal
absorption
factor
of
4%,
is
potentially
of
concern.
3.3.8
Inhalation
Exposure
(
All
Durations)
Except
for
an
acute
inhalation
study,
for
which
diuron
was
placed
in
Toxicity
Category
4
(
LC
50
>
7.1
mg/
L),
no
other
studies
are
available
via
this
route.
Therefore,
the
HIARC
selected
the
NOAELs
from
oral
studies
for
risk
assessment.
Since
the
doses
identified
for
inhalation
risk
assessment
are
from
oral
studies,
route
to
route
extrapolation
should
be
as
follows:
The
inhalation
exposure
component
(
i.
e.,
F
g
a.
i./
day)
using
a
100%
(
default)
absorption
rate
and
application
rate
should
be
converted
to
an
equivalent
oral
dose
(
mg/
kg/
day).
Then,
the
oral
equivalent
doses
should
be
compared
to
the
following
NOAELs/
LOAEL
to
calculate
the
MOEs.
Short
term
NOAEL=
10
mg/
kg/
day
(
developmental
rabbit
study)
Intermediate
term
NOAEL=
1.0
mg/
kg/
day
(
chronic
rat
study
at
6
month)
Long
term
LOAEL=
1.0
mg/
kg/
day
(
chronic
rat
study)
A
UF
of
100
for
short
and
intermediate
term
exposures
and
a
UF
of
300
(
additional
3
is
applied
to
account
for
the
lack
of
a
NOAEL
in
the
study)
for
long
term
exposures,
and
the
FQPA
safety
factor
of
1x,
were
applied
to
the
risk
assessment;
therefore
the
LOCs
=
100,
100,
and
300,
respectively.
Short
term
inhalation
LOC
=
100
Intermediate
term
inhalation
LOC
=
100
Long
term
inhalation
LOC
=
300
3.3.9
Carcinogenic
Potential
3.3.9.1
Combined
Chronic
Toxicity/
Carcinogenicity
Study
in
Rats
An
acceptable/
guideline
combined
chronic
toxicity/
carcinogenicity
study
in
rats
was
submitted
(
MRID#
40886501,
43871901,
43804501,
44302003).
This
study
showed
conclusive
evidence
for
the
carcinogenicity
of
diuron
in
male
and
female
rats.
The
incidence
of
urinary
bladder
carcinoma
was
increased
at
2500
ppm
in
both
sexes
(
males:
33/
49
vs.
1/
50
for
controls;
females:
11/
50
vs.
0/
48
for
17
controls;
p<
0.01).
The
malignancies
were
usually
characterized
as
transitional
epithelial
carcinomas.
The
slight
increase
(
not
statistically
significant)
in
the
incidence
of
urinary
bladder
papillomas
and
the
3
neoplasms
in
the
renal
pelvis
in
high
dose
males
(
one
papilloma
and
two
carcinomas)
were
also
considered
treatment
related.
Dosing
was
adequate
based
on
numerous
toxic
effects
(
hematological,
microscopic,
etc.)
observed
in
the
animals
at
all
tested
doses.
3.3.9.2
Carcinogenicity
Study
in
Mice
An
acceptable/
guideline
carcinogenicity
study
in
mice
was
submitted
(
MRID#
42159501,
43349301).
Treatment
of
up
to
102
weeks
with
2500
ppm
diuron
resulted
in
a
significant
increase
in
the
incidences
of
mammary
adenocarcinomas
(
control,
4%;
2500
ppm,
12%,
p
#
0.05)
and
ovarian
luteomas
(
control,
6%;
2500
ppm,
14%,
p
#
0.01)
in
female
NMRI
(
SPF
HAN)
mice
under
the
conditions
of
this
study.
However,
the
incidence
of
mammary
adenocarcinoma
in
high
dose
females
was
at
or
near
the
high
range
of
incidences
seen
in
historic
controls.
Dosing
was
adequate
based
on
observations
at
the
highest
dose
tested,
including
decreased
body
weight
of
both
sexes,
increased
spleen
and
liver
weights
in
males
and
increased
incidence
of
urinary
bladder
edema
and
epithelial
hyperplasia,
thickened
mucosa
and
enlarged
uterine
horn
in
females.
3.3.9.3
Classification
of
Carcinogenic
Potential
The
HED
Carcinogenicity
Peer
Review
Committee
(
CPRC)
met
on
December
18,
1996
and
classified
diuron
as
a
"
known/
likely"
human
carcinogen,
based
on
urinary
bladder
carcinomas
in
both
sexes
of
the
Wistar
rat,
kidney
carcinomas
in
the
male
rat
(
a
rare
tumor),
and
mammary
gland
carcinomas
in
the
female
NMRI
mouse
(
Carcinogenicity
Peer
Review
of
Diuron.
Linda
Taylor
and
Esther
Rinde.
May
8,
1997).
The
CPRC
also
recommended
a
low
dose
linear
extrapolation
model
with
a
Q1
*
of
1.91
x
10
2
(
mg/
kg/
day)
1
be
applied
to
the
animal
data
for
the
quantification
of
human
risk,
based
on
the
urinary
bladder
carcinomas
in
the
rat
(
Diuron
Revised
Q1*,
(
3/
4'
s
Interspecies
Scaling
Factor),
1985
Wistar
Rat
2
Year
Dietary
Study.
PC
035505.
Bernice
Fisher.
September
23,
1998).
3.3.10
Mutagenicity
Acceptable
genetic
toxicology
studies
with
diuron
have
been
submitted
to
the
Agency.
Findings
from
these
studies
indicated
the
following:
Gene
Mutations
1)
Salmonella
typhimurium
reverse
gene
mutation
assay
(
MRID#
00146608/
40228805):
Independent
trials
were
negative.
2)
Chinese
Hamster
Ovary
(
CHO)/
HGPRT)
cell
forward
gene
mutation
assay
(
MRID#
00146609):
Independent
tests
were
negative
up
to
cytotoxic
doses
with/
without
S9
activation.
Chromosome
Aberrations
18
3)
In
vivo
bone
marrow
cytogenetic
assay
in
male
Sprague
Dawley
rats
administered
0,
50,
500
or
5000
mg/
kg/
day
by
single
oral
gavage
(
MRID#
00146611
and
44350301):
The
test
was
negative.
Signs
of
overt
toxicity
(
mortality,
body
weight
loss,
ocular
discharge,
depression,
labored
respiration,
diarrhea,
and
tremors)
were
noted
at
5000
mg/
kg.
Cytotoxicity
to
the
target
organ
as
indicated
by
the
significantly
decreased
(
p
#
0.01)
mitotic
indices
at
24
and
48
hours
for
high
dose
males;
data
combined
for
both
sexes
were
also
significantly
decreased
at
24
hours.
A
significant
positive
linear
trend
was
also
recorded
for
the
combined
(
by
sex)
aberrations
per
cell
and
the
percentage
of
abnormal
cells.
Nevertheless,
the
values
fell
well
within
the
range
of
historical
controls.
4)
Mouse
bone
marrow
micronucleus
assays
(
MRIDs
45494502
05):
Preliminary
review
indicates
no
evidence
of
cytogenetic
effect
in
mice
administered
either
technical
grade
or
formulated
diuron.
Other
Mutagenic
Mechanisms
5)
Unscheduled
DNA
synthesis
(
UDS)
in
primary
rat
hepatocytes
assay
(
MRID#
00146610):
The
test
was
negative
up
to
cytotoxic
doses.
Diuron
was
not
mutagenic
in
bacteria
or
in
cultured
mammalian
cells
and
no
indication
of
DNA
damage
in
primary
rat
hepatocytes
was
observed.
There
were
marginal
statistically
significant
increases
in
cells
with
structural
aberrations
in
a
Sprague
Dawley
rat
in
vivo
bone
marrow
chromosomal
aberration
assay.
However,
the
levels
of
aberrations
were
within
the
historical
control
range
and
assessed
negative.
3.3.11
Mechanism
of
Carcinogenicity
In
1996,
the
HED
CPRC
classified
diuron
as
a
"
known/
likely"
human
carcinogen,
based
on
urinary
bladder
carcinoma
in
both
sexes
of
the
Wistar
rat,
kidney
carcinomas
in
the
male
rat
(
a
rare
tumor),
and
mammary
gland
carcinomas
in
the
female
NMRI
mouse
[
Diuron
(
PC
035505):
Assessment
of
Mode
of
Action
on
Bladder
Carcinogenicity.
Yung
Yang.
September
20,
2001].
The
CPRC
also
recommended
a
low
dose
linear
extrapolation
model
with
Q1
*
of
1.91x10
2
(
mg/
kg/
day)
1
be
applied
to
the
animal
data
for
the
quantification
of
human
risk,
based
on
the
urinary
bladder
carcinomas
in
the
rat.
The
registrant
has
argued
that
this
assessment
needed
reconsideration
for
the
following
reasons
(
MRID
45494501):
1)
there
is
no
history
of
human
carcinogenesis
as
a
result
of
diuron
exposure,
2)
there
is
a
plausible
mode
of
action
that
discounts
the
relevance
of
the
rat
bladder
carcinomas
to
humans,
3)
the
mouse
historical
data
were
not
considered
in
their
entirety
and
should
be
considered
`
spontaneous,"
4)
the
structure
activity
relationships
actually
decrease
the
weight
of
the
evidence
of
diuron
carcinogenicity
rather
than
increase
the
weight,
and
5)
new
guidelines
are
in
place
that
separate
the
`
known'
from
`
likely'
category.
The
Agency's
CPRC
and
Mechanism
of
Toxicity
Assessment
Review
Committee
(
MTARC)
have
reviewed
the
submitted
information/
data
[
Cancer
Classification
and
Mechanism
of
Action
(
MRID
19
45494501)
and
mutagenicity
studies
(
MRIDs
45494502
05)],
considered
the
registrant's
proposed
mechanism
of
action
and
determined
that
diuron
will
not
be
re
classified
at
this
time
(
DIURON:
Cancer
Classification
and
Mechanism
of
Action.
Yung
Yang.
October
10,
2001).
The
Agency
based
its
decision
on:
1)
the
registrant
did
not
submit
any
data
or
information
to
support
its
claim
that
there
is
no
evidence
of
human
carcinogenesis,
2)
the
submitted
information
is
insufficient
to
support
a
mode
of
action
on
bladder
carcinogenicity
for
diuron,
3)
the
mouse
historical
data
have
been
reviewed
and
included
in
the
updated
DER
(
MRIDs
42159501
and
43349301)
and
the
Agency
concluded
that
a
positive
oncogenic
response
was
seen
in
high
dose
female
mice
compared
to
the
control
group,
4)
there
is
insufficient
evidence
to
support
the
notion
that
the
structure
activity
relationships
actually
decrease
the
weight
of
the
evidence
of
diuron
carcinogenicity
rather
than
increase
the
weight,
and
5)
preliminary
reviews
have
been
conducted
on
newly
submitted
in
vivo
cytogenetic
mutagenicity
studies
[
Mouse
bone
marrow
micronucleus
assays
(
MRIDs
45494502
05)]
and
no
evidence
of
cytogenetic
effect
was
seen
in
mice
administered
either
technical
grade
or
formulated
diuron;
however,
these
studies
provide
little
additional
information
since
the
CPRC
has
already
concluded
that
there
is
little
or
no
concern
for
the
mutagenic
activity
of
diuron.
20
Table
4.
Summary
of
Toxicology
Endpoint
Selection
EXPOSURE
SCENARIO
DOSE
(
mg/
kg/
day)
ENDPOINT
STUDY
Acute
Dietary
No
appropriate
endpoint
attributed
to
a
single
dose
was
identified.
Therefore,
an
acute
RfD
was
not
established.
Chronic
Dietary
LOAEL
=
1.0
UF
=
300
FQPA
SF
=
1*
Evidence
of
hemolytic
anemia
and
compensatory
hematopoiesis
(
significantly
decreased
erythrocyte
counts,
hemoglobin
levels,
and
hematocrit,
and
increased
MCV,
MCH,
abnormal
erythrocyte
forms,
reticulocyte
counts,
and
leukocyte
count)
Combined
chronic
toxicity/
carcinogenicity
study
in
rats
MRID
40886501,
43871901,
43804501,
44302003
Chronic
RfD
=
0.003
mg/
kg/
day
cPAD
=
0.003
mg/
kg/
day
Incidental
Oral,
short
term
(
1
30
days)
NOAEL=
10
UF
=
100
FQPA
SF
=
1*
Decreased
body
weight
and
food
consumption
at
maternal
LOAEL
of
50
mg/
kg/
day.
Developmental
toxicity
study
in
rabbits
MRID
40228802
LOC
for
residential
MOE
=
100
Incidental
Oral,
Intermediate
Term
(
1
6
months)
NOAEL
=
1.0
UF
=
100
FQPA
SF
=
1*
Altered
hematological
parameters
at
LOAEL
of
10
mg/
kg/
day,
observed
at
6
months.
Chronic
toxicity/
carcinogenicity
study
in
rats
MRID
40886501,
43871901,
43804501,
44302003
LOC
for
residential
MOE
=
100
Dermal,
Short
Intermediate
Term
No
systemic
toxicity
was
seen
following
repeated
dermal
dosing
at
1200
mg/
kg/
day
in
the
rabbit
dermal
toxicity
study.
Also,
there
is
no
developmental
concern.
No
hazard
was
identified
and
no
quantitative
assessment
is
required.
Dermal,
Long
Term
(
6
months
to
lifetime
Absorption
factor
of
4%
used
for
conversion
from
oral
to
dermal
route
LOAEL
=
1.0
UF
=
300
FQPA
SF
=
1*
Evidence
of
hemolytic
anemia
and
compensatory
hematopoiesis
(
significantly
decreased
erythrocyte
counts,
hemoglobin
levels,
and
hematocrit,
and
increased
MCV,
MCH,
abnormal
erythrocyte
forms,
reticulocyte
counts,
and
leukocyte
count).
Chronic
toxicity/
carcinogenicity
study
in
rats
MRID
40886501,
43871901,
43804501,
44302003
LOC
for
occupational/
residential
MOE
=
300
Inhalation,
Short
Term
(
1
30
days)**
NOAEL
=
10
UF
=
100
FQPA
SF
=
1*
Decreased
body
weight
and
food
consumption
at
maternal
LOAEL
of
50
mg/
kg/
day.
Developmental
toxicity
study
in
rabbits
MRID
40228802
LOC
for
occupational/
residential
MOE
=
100
21
Inhalation,
Intermediate
Term
(
1
6
months)**
NOAEL
=
1.0
UF
=
100
FQPA
SF
=
1*
Altered
hematological
parameters
at
LOAEL
of
10
mg/
kg/
day,
observed
at
6
months.
Chronic
toxicity/
carcinogenicity
study
in
rats
MRID
40886501,
43871901,
43804501,
44302003
LOC
for
occupational/
residential
MOE
=
100
Inhalation,
Long
Term
(
6
months
to
life
time)**
LOAEL
=
1.0
UF
=
300
FQPA
SF
=
1*
Evidence
of
hemolytic
anemia
and
compensatory
hematopoiesis
(
significantly
decreased
erythrocyte
counts,
hemoglobin
levels,
and
hematocrit,
and
increased
MCV,
MCH,
abnormal
erythrocyte
forms,
reticulocyte
counts,
and
leukocyte
count).
Chronic
toxicity/
carcinogenicity
study
in
rats
MRID
40886501,
43871901,
43804501,
44302003
LOC
for
occupational/
residential
MOE
=
300
Cancer
Known/
likely
human
carcinogen
Urinary
bladder
carcinoma
in
both
sexes
of
the
Wistar
rat,
kidney
carcinomas
in
the
male
rat
(
a
rare
tumor),
and
mammary
gland
carcinomas
in
the
female
NMRI
mouse
Carcinogenicity
study
in
rats
and
mice
MRID
40886501,
43871901,
43804501,
44302003
and
42159501,
43349301
Q1*
=
1.91
x
10
2
(
mg/
kg/
day)
1
*
FQPA
SF
only
applied
to
residential
and
other
non
occupational
exposures
**
An
oral
endpoint
was
used
for
inhalation
exposure:
inhalation
exposure
assumed
equivalent
to
oral
exposure.
3.4
Endocrine
Disruption
EPA
is
required
under
the
FFDCA,
as
amended
by
FQPA,
to
develop
a
screening
program
to
determine
whether
certain
substances
(
including
all
pesticide
active
and
other
ingredients)
"
may
have
an
effect
in
humans
that
is
similar
to
an
effect
produced
by
a
naturally
occurring
estrogen,
or
other
such
endocrine
effects
as
the
Administrator
may
designate."
Following
the
recommendations
of
its
Endocrine
Disruptor
Screening
and
Testing
Advisory
Committee
(
EDSTAC),
EPA
determined
that
there
was
scientific
bases
for
including,
as
part
of
the
program,
the
androgen
and
thyroid
hormone
systems,
in
addition
to
the
estrogen
hormone
system.
EPA
also
adopted
EDSTAC's
recommendation
that
the
Program
include
evaluations
of
potential
effects
in
wildlife.
For
pesticide
chemicals,
EPA
will
use
FIFRA
and,
to
the
extent
that
effects
in
wildlife
may
help
determine
whether
a
substance
may
have
an
effect
in
humans,
FFDCA
authority
to
require
the
wildlife
evaluations.
As
the
science
develops
and
resources
allow,
screening
of
additional
hormone
systems
may
be
added
to
the
Endocrine
Disruptor
Screening
Program
(
EDSP).
When
the
appropriate
screening
and/
or
testing
protocols
being
considered
under
the
Agency's
EDSP
have
been
developed,
diuron
may
be
subjected
to
additional
screening
and/
or
testing
to
better
22
characterize
effects
related
to
endocrine
disruption.
At
this
time,
neither
the
available
submitted
studies
on
diuron
nor
the
literature
show
any
indication
of
endocrine
disruption
effects.
3.5
Potential
Tetrachloroazobenzene
Contamination
Diuron
has
been
reported
to
contain
trace
amounts
of
a
manufacturing
impurity,
3,3',
4,4'
tetrachloroazobenzene,
a.
k.
a.
TCAB,
which
has
been
shown
to
be
a
cytochrome
P450
enzyme
inducer.
A
summary
of
short
term
bioassays
compiled
by
the
National
Toxicology
Program
states
that
(
TOX
65,
1998),
"
3,3',
4,4'
tetrachloroazobenzene
caused
typical
dioxin
like
effects,
such
as
thymic
atrophy,
an
increase
in
liver
weights,
induction
of
hepatic
cytochrome
P4501A,
and
decreased
mean
body
weight
gains.
Furthermore,
in
the
13
week
studies,
a
sharp
decrease
in
circulating
thyroxine
concentrations
was
observed
even
at
the
lowest
dose
(
0.1
mg/
kg)
tested
in
rats.
Other
effects
included
a
decrease
in
epididymal
spermatozoal
concentration
in
mice,
major
effects
on
the
hematopoietic
system,
and
increased
incidences
of
hyperplasia
of
the
forestomach
in
3
and
30
mg/
kg
males
and
30
mg/
kg
females.
A
no
observable
adverse
effect
level
(
NOAEL)
was
not
reached
in
rats.
The
NOAEL
in
mice
was
0.1
mg/
kg.
Comparison
of
various
dioxin
like
effects
in
these
studies
with
those
reported
in
the
literature
indicate
that
3,3',
4,4'
tetrachloroazobenzene
is
six
to
two
orders
of
magnitude
less
potent
than
2,3,7,8
tetrachlorodibenzo
p
dioxin."
Chronic
toxicity/
carcinogenicity
studies
are
not
available
for
TCAB.
The
specific
endpoint(
s)
and
related
dose
levels
that
may
be
observed
in
chronic
toxicity
studies,
or
the
specific
carcinogenic
potential
of
this
compound
is
not
known.
However,
since
it
is
assumed
that
TCAB
may
have
been
present
in
all
diuron
toxicological
test
materials,
including
the
test
material
for
the
chronic
toxicity/
carcinogenicity
studies,
the
Agency
believes
that
the
risks
from
exposure
to
diuron
(
including
carcinogenic
potential)
have
not
been
underestimated.
4.0
EXPOSURE
ASSESSMENT
AND
CHARACTERIZATION
4.1
Summary
of
Registered
Uses
Diuron
is
an
herbicide
currently
registered
for
use
on
a
variety
of
fruit,
vegetable,
nut,
and
field
crops.
At
this
time,
products
containing
diuron
are
intended
for
both
occupational
and
non
occupational
(
residential)
uses.
Occupational
uses
include
agricultural
food
and
non
food
crops;
fruit
and
nut
crops;
ornamental
trees,
flowers,
and
shrubs;
paints
and
coatings;
ornamental
fish
and
catfish
production;
and
non
crop
areas
such
as
rights
of
way
and
industrial
sites.
Non
occupational
uses
include
residential
ponds,
aquariums,
and
paints.
23
Diuron
is
a
pre
and
post
emergent
herbicide
that
controls
a
wide
variety
of
annual
and
perennial
broad
leafed
and
grassy
weeds
on
both
crop
and
non
crop
sites.
Examples
of
the
types
of
weeds
that
diuron
is
used
to
control
include
(
but
are
not
limited
to)
the
following:
button
weed,
pigweed,
carpetweed,
poison
ivy,
milkweed,
vines,
chickweed,
ragweed,
aster,
thistle,
dandelion,
morning
glory,
mustard,
wild
turnip,
pepper
weed,
wild
oat,
Bermuda
grass,
orchard
grass,
crabgrass,
love
grass,
fescue,
velvet
grass,
rye
grass,
witch
grass,
and
blue
grass.
Diuron
is
also
used
as
a
mildewcide
in
paints
and
an
algaecide
in
ponds.
Diuron
is
formulated
as
a
technical
product
and
formulation
intermediate
(
98.8
to
80
%
ai),
granular
(
0.2
%
to
20
%
ai),
pellet/
tablet
(
0.51
%
to
19
%
ai),
wettable
powder
(
25
%
to
80
%
ai),
dry
flowable
(
water
dispersible
granules;
40
%
to
80
%
ai),
emulsifiable
concentrate
(
2
%
to
80
%
ai),
flowable
concentrate
(
19
%
to
47.5
%
ai),
soluble
concentrate
(
5.1
%
to
40
%
ai),
and
ready
to
use
solution
(
0.67
%
to
19
%
ai).
Application
rates
range
from
0.8
to
87.1
lbs
ai/
acre.
Equipment
for
commercial
use
includes
groundboom
sprayer,
aerial
equipment,
chemigation,
rightsof
way
sprayer,
high
pressure
handwand,
low
pressure
handwand,
tractor
drawn
spreader,
push
type
spreader,
airless
sprayer,
paintbrush,
shaker
type
applicator,
backpack
sprayer,
backpack
granular
spreader,
belly
grinder,
and
by
hand.
Products
intended
for
residential
use
may
be
applied
using
a
spoon,
by
hand,
by
airless
sprayer,
or
by
paintbrush/
roller.
Diuron
is
generally
applied
to
the
soil
prior
to
germination
of
weed
seeds
or
when
weeds
are
in
an
active
growth
stage.
Diuron
may
also
be
applied
as
a
post
emergent
herbicide,
either
as
a
directed
spray
or
over
the
top
of
resistant
foliage.
It
may
be
applied
one
to
two
times
per
season,
with
the
exception
of
sugarcane
(
three
times
per
season)
to
control
a
wide
range
of
broad
leafed
and
grassy
weeds.
Occupational
Use
Sites
The
occupational
crop
use
sites
in
this
assessment
have
been
grouped
as
follows:
Vegetables
and
Field
Crops:
alfalfa
(
forage),
artichokes,
asparagus,
barley,
blackberries,
boysenberries,
blueberries,
cane
berries,
corn
(
field
corn
only),
cotton,
currants,
dewberries,
elderberries,
gooseberries,
grapes,
huckleberries,
loganberries,
mint,
oats,
olives,
peas
(
field
or
southern),
pineapples,
raspberries,
sorghum,
sugarcane,
and
wheat.
Fruit
and
Nut
Trees
(
orchard
crops),
including
apples,
bananas,
citrus,
filberts
(
hazelnuts),
macadamia
nuts,
pecans,
peaches,
pears,
papayas,
plantains,
and
walnuts.
Ornamental
Trees,
Flowers,
and
Shrubs,
including
shade
trees,
citrus
trees
(
non
bearing
and
nursery
stock),
tree
plantings
(
including
ash,
cedar,
elm,
oak,
pine,
poplar,
and
fir),
Easter
lilies,
gladiolus,
iris,
lilies,
narcissus,
and
ornamental
grasses.
24
Cotton
Defoliant
(
state
labels
only)
Non
crop
Areas,
including
rights
of
way;
industrial
sites;
drainage
systems;
irrigation
systems;
lakes,
ponds,
holding
basins,
and
other
similar
sites
that
have
been
drained;
airports
and
landing
fields;
fire
plugs;
cable
closures;
and
warehouses.
Paints,
Solvents,
Adhesives,
and
Coatings
Ornamental
Fish
and
Catfish
Ponds
Residential
Use
Sites
Residential
Ponds
and
Aquariums
Paints,
Solvents,
Adhesives,
and
Coatings
4.2
Dietary
Exposure/
Risk
Pathway
Tolerances
range
from
0.05
ppm
(
meats,
milk)
to
7
ppm
in/
on
asparagus
(
Residue
Chemistry
Chapter
for
the
Diuron
Reregistration
Eligibility
Decision
Document.
John
Punzi.
July
29,
2001).
Diuron
is
applied
1
or
2
times
per
season
using
single
application
rates
of
approximately
1
pound
per
acre.
Usage
data
concerning
domestic
percent
crop
treated
data
from
the
Biological
and
Economic
Assessment
Division
(
BEAD)
indicate
that
~
50%
of
citrus,
25%
of
berries,
15%
of
nuts,
10%
of
cotton,
grapes,
peaches,
or
pome
fruit,
and
1%
of
field
crops
are
treated
with
diuron.
Nearly
10
million
pounds
of
diuron
are
used
annually
in
the
United
States.
Tolerances
for
residues
of
diuron
in/
on
plant
and
animal
commodities
are
established
under
40
CFR
§
180.106.
Diuron
tolerances
are
currently
expressed
as
diuron
per
se.
The
Agency
is
recommending
that
the
tolerance
expression
for
diuron
be
revised
to
include
metabolites
hydrolyzable
to
3,4
dichloroaniline
(
3,4
DCA).
This
determination
is
based
on
the
results
of
the
reviewed
plant
and
animal
metabolism
studies.
Adequate
analytical
methods
exist
for
data
collection
and
tolerance
enforcement
in
plants.
Independent
laboratory
validation
of
the
enforcement
method
is
required
for
livestock
methods
prior
to
Agency
validation.
Label
revisions
are
required
for
many
crops
in
order
to
reflect
the
parameters
of
use
patterns
for
which
residue
data
are
available.
Many
of
the
revisions
concern
retreatment
intervals,
preharvest
intervals
(
PHI's)
and
rotational
crop
restrictions.
The
Metabolism
Assessment
Review
Committee
(
MARC)
met
on
July
3,
2001
to
discuss
the
metabolism
of
diuron
in
plants
and
animals
from
the
results
of
wheat,
corn,
orange,
ruminant,
and
poultry
studies
together
with
the
environmental
fate
studies
conducted
in
soil
and
water
(
Diuron
Metabolism
Committee
Briefing
Memo.
John
Punzi.
August,
27,
2001).
25
NH
N
O
Cl
Cl
CH
3
CH
3
NH
NH
O
Cl
Cl
CH
3
NH
NH
2
O
Cl
Cl
The
14C
containing
residues
that
were
identified
in
plants
(
Table
5):
diuron,
3,4
dichlorophenylurea
(
DCPU),
and
3(
3,4
dichlorophenyl)
1
methylurea
(
DCPMU).
No
other
dichloroaniline
containing
metabolites
were
identified.
The
majority
of
radioactivity
in
the
aqueous/
organic
fractions
was
characterized
as
polar
unknowns.
Radiovalidation
of
a
GC/
ECD
data
collection
method
which
is
similar
to
the
enforcement
method
suggested
that
a
good
portion
of
these
polar
metabolites
can
be
converted
to
3,4
DCA.
Table
5.
Parent
and
Major
Metabolites
Diuron:
3(
3,4
dichlorophenyl)
1,1
dimethylurea
DCPMU;
IN
15654:
3(
3,4
dichlorophenyl)
1
methylurea
DCPU;
IN
R915:
3,4
dichlorophenylurea
In
animals,
the
principal
residue
identified
was
DCPU.
The
parent
and
other
dichloroanilinecontaining
metabolites
(
i.
e.,
3,4
DCA
and
DCPMU)
that
can
be
determined
by
the
current
enforcement
methods
were
detected
in
much
smaller
quantities.
Four
minor
hydroxylated
metabolites
(
2
OH
DCA;
2
OH
DCPU;
2
OH
DCPMU;
and
N
acetyl
2
OH
DCA)
were
also
detected;
these
metabolites
were
not
observed
in
plants
and
would
not
be
determined
by
the
current
enforcement
method.
The
major
portion
of
radioactive
residues
in
milk
(
in
lactating
goats)
was
comprised
of
several
conjugated
polar
components
which
collectively
accounted
for
56%
of
total
radioactive
residue
(
TRR).
These
polar
components
also
accounted
for
substantial
portions
of
the
total
radioactivity
in
liver
(
collectively
25%
of
TRR)
and
kidney
(
collectively
23%
of
TRR).
Attempts
to
further
elucidate
the
nature
of
these
polar
materials
using
various
techniques
(
e.
g.,
enzyme
digestions,
heat
treatment)
were
not
successful.
Although
these
polar
components
were
not
wholly
identified,
the
registrant
noted
that
the
results
from
a
radiovalidation
study
suggest
that
a
large
portion
of
these
polar
components
are
hydrolyzable
to
3,4
DCA
and
would
be
quantified
using
the
residue
enforcement
method.
The
environmental
data
base
indicates
that
diuron
has
potential
for
leaching
to
ground
and
surface
water.
The
environmental
metabolism
studies,
conducted
under
a
variety
of
conditions,
demonstrate
that
monochlorinated
methylphenyl
urea
(
MCMPU)
and
monochlorinated
dimethylphenyl
urea
(
MCDMPU)
can
be
formed
under
some
conditions
and
that
MCDMPU
is
a
major
degradate
in
aquatic
aerobic
and
anaerobic
studies.
DCPMU
was
also
identified
as
a
major
environmental
degradate
in
several
studies
and
3,4
DCA,
DCMU,
PDMU
were
identified
as
minor
metabolites.
The
MARC
concluded
that
for
tolerance
expression
and
risk
assessment
purposes,
the
residues
of
26
concern
in/
on
plants
and
animals
are
diuron
and
its
metabolites
that
are
hydrolyzable
to
3,4
DCA
[
Diuron.
Results
of
the
Health
Effects
Division
(
HED)
Metabolism
Assessment
Review
Committee(
MARC)
Meeting
Held
on
03
JULY
2001.
John
Punzi.
August
10,
2001].
This
decision
was
based
on:
1)
the
assumption
that
the
metabolites
would
not
be
any
more
toxic
than
the
parent
and
2)
the
consideration
that
the
analytical
methods
used
to
collect
the
field
trial
data
are
not
capable
of
measuring
each
metabolite
individually.
To
account
for
the
poor
recovery
of
hydroxylated
metabolites
from
milk,
it
was
determined
that
the
levels
of
diuron
residues
in
milk
identified
in
the
ruminant
feeding
study
would
be
multiplied
by
10
(
The
Metabolism
Committee
Meetings
for
Diuron
Held
on
October
21
and
November
5,
1993.
Randy
Perfetti.
November
17,
1993)
to
account
for
all
of
the
exposure
to
diuron
related
residues
in
the
risk
assessment.
The
MARC
also
concluded
that
for
risk
assessment
purposes,
the
residues
of
concern
in
drinking
water
are
parent,
and
metabolites
that
are
hydrolyzable
to
3,4
DCA,
and
MCPDMU.
The
MARC
raised
concerns
for
MCPDMU
based
on
an
analogous
compound,
monuron.
With
the
exception
of
the
position
of
the
chlorine,
the
structures
are
identical.
There
are
cancer
concerns
for
monuron
but
the
target
organs
are
different
than
those
affected
by
diuron.
The
MARC
recommended
that
a
separate
cancer
assessment
be
conducted
for
MCPDMU.
4.2.1
Residue
Profile
Diuron
is
used
on
a
wide
variety
of
food
and
feed
crops.
Residue
levels
from
United
States
Department
of
Agriculture
(
USDA)
and
Food
and
Drug
Administration
(
FDA)
monitoring
programs
do
not
include
all
the
residues
of
concern
needed
for
the
Agency's
diuron
risk
assessment
(
diuron
and
metabolites
convertible
to
3,4
DCA)
and
would
be
inappropriate
for
this
analysis.
Anticipated
residues
(
ARs)
from
field
trial
data
were
utilized
to
estimate
the
dietary
exposure
to
diuron
from
the
diets
of
the
U.
S.
population
as
well
as
certain
population
subgroups.
These
ARs
were
developed
previously
(
D250038,
Rick
Loranger.
October
8,
1998
and
D169227,
Christina
Swartz.
April
27,
2001).
The
field
trials
were
conducted
at
the
highest
application
rates
for
the
crop
tested
and
therefore,
the
residues
from
these
trials
are
considered
high
end.
Available
processing
data
for
apple,
citrus
and
grapes
were
available
and
indicated
that
there
was
no
concentration,
nor
reduction,
in
residue
values
for
these
processed
commodities
(
i.
e.
juice,
dried
fruit).
The
sugarcane
processing
study
showed
a
reduction
of
residues
in
refined
sugar
but
a
concentration
of
residues
in
molasses.
With
the
exception
of
residue
data
from
the
processing
of
sugarcane
into
refined
sugar
and
molasses,
the
only
additional
refinements
to
the
residue
data
are
the
use
of
averaged
percent
crop
treated
(%
CT)
information
(
Quantitative
Usage
Analysis
for
Diuron.
Alan
Halvorson.
March
20,
2001
and
Updated
QUA.
Alan
Halvorson.
April
27,
2001).
The
registrants
have
committed
to
label
changes
which
would
restrict
the
application
of
diuron
to
asparagus
plantings
prior
to
the
appearance
of
spears.
Residues
of
diuron
in/
on
asparagus
are
reduced
by
approximately
one
order
of
magnitude
(
from
2.8
to
0.26
ppm)
by
this
proposed
use.
To
examine
the
effect
of
the
differing
residue
values
for
asparagus
on
the
dietary
risk,
calculations
were
performed
using
27
residue
levels
reflecting
treatment
of
asparagus
crops
before
and
after
spears
appear.
There
were
minimal
changes
in
the
chronic
exposure
estimates
using
data
from
pre
emergence
or
post
emergence
applications
of
diuron
to
asparagus.
4.2.2
Acute
Dietary
Diuron
is
not
acutely
toxic.
No
adverse
effects
attributed
to
a
single
exposure
were
identified
in
any
available
study.
Therefore,
no
acute
dietary
risk
assessment
was
conducted.
4.2.3
Chronic
Dietary
A
chronic
exposure
analysis
for
diuron
and
its
metabolites
that
are
hydrolyzable
to
3,4
DCA
was
performed
utilizing
the
Dietary
Exposure
Evaluation
Model
(
DEEMTM)
software
Version
7.73,
which
incorporates
USDA's
Continuing
Surveys
of
Food
Intake
by
Individuals
(
CSFII),
1989
1992.
The
1989
1992
data
are
based
on
the
reported
consumption
patterns
of
more
than
10,000
individuals
over
three
consecutive
days,
and
therefore
represent
more
than
30,000
unique
"
person
days"
of
data.
Foods
"
as
consumed"
(
e.
g.
apple
pie)
are
linked
to
raw
agricultural
commodities
and
their
food
forms
(
e.
g.
apples
cooked/
canned
or
wheat
flour)
by
proprietary
recipe
translation
files
within
DEEM.
Consumption
data
are
averaged
for
the
entire
U.
S.
population
and
within
population
subgroups
for
chronic
exposure
assessment.
For
chronic
exposure
and
risk
assessment,
an
estimate
of
the
residue
level
in
each
food
or
food
form
(
e.
g.
orange
or
orange
juice)
on
the
commodity
residue
list
is
multiplied
by
the
average
daily
consumption
estimate
for
that
food/
food
form.
The
resulting
residue
consumption
estimate
for
each
food/
food
form
is
summed
with
the
residue
consumption
estimates
for
all
other
food/
food
forms
on
the
commodity
residue
list
to
arrive
at
the
total
estimated
exposure.
The
calculated
chronic
exposure
(
residue
x
consumption)
was
compared
to
a
cPAD
of
0.003
mg/
kg/
day,
which
reflects
an
FQPA
factor
of
1x.
Noncancer
dietary
exposure
estimates
are
expressed
in
mg/
kg
bw/
d
and
as
a
percent
of
the
cPAD
(
Diuron
Chronic
Dietary
Exposure
Assessment
(
PC
Code
035505);
DP
Barcode
D276683;
Case
0046.
John
Punzi.
September
10,
2001).
Estimated
chronic
dietary
(
food)
risk
estimates
associated
with
the
use
of
diuron
do
not
exceed
the
Agency's
level
of
concern
(>
100%
cPAD)
for
any
population
subgroup
including
the
most
highly
exposed
population
subgroup,
children
ages
1
6
years.
The
chronic
dietary
risk
for
children
ages
1
6
years
is
7%
of
the
chronic
PAD
and
3%
for
the
general
U.
S.
population
(
Table
6).
Approximately
40%
of
the
exposure
to
diuron
from
food
is
from
orange
juice
and
orange
juice
concentrate.
Table
6:
Chronic
Dietary
Risk
Estimates
Population
Exposure
mg/
kg/
day
%
Chronic
PAD
U.
S.
Population
0.000088
3
All
Infants
(<
1
year)
0.000077
3
Population
Exposure
mg/
kg/
day
%
Chronic
PAD
28
Children
1
6
years
0.00020
7
Children
7
12
years
0.000118
4
Females
13
50
years
0.000069
2
Males
13
19
years
0.000098
3
Males
20+
years
0.000066
2
Seniors
55+
years
0.000083
3
4.2.4
Cancer
Dietary
The
estimated
cancer
dietary
risk
associated
with
the
use
of
diuron
indicates
a
borderline
exceedance
above
1
x
10
6
and
shows
a
lifetime
risk
estimate
of
1.68
x
10
6
for
the
general
population
but,
is
not
of
concern
(
Table
7).
As
discussed
earlier,
the
residues
used
in
the
calculations
are
from
field
trials
conducted
at
the
highest
application
rates
and
some
processing
data
are
still
outstanding.
Therefore,
the
exposure
calculation
is
a
conservative
estimate.
Again,
the
Agency
assumed
that
exposure
was
to
diuron
and
its
metabolites
that
are
hydrolyzable
to
3,4
DCA.
For
the
cancer
risk
assessment,
the
calculated
chronic
exposure
(
residue
x
consumption)
was
calculated
with
a
Q1*
of
1.91
x
10
2
(
mg/
kg/
day)
1
in
human
equivalents.
Table
7.
Summary
of
Dietary
Exposure
and
Risk
for
Diuron
Population
Acute
Dietary
Chronic
Dietary
Cancer
Dietary
NA
Exposure
(
mg/
kg/
day)
Risk
(%
cPAD)
Exposure
(
mg/
kg/
day)
Lifetime
Risk
(
Q1*=
0.0191)
U.
S.
Population
0.000088
3
0.000088
1.68
x
10
6
All
Infants
<
1
year
0.000077
3
Not
Applicable
Children
1
6
years
0.000200
7
Children
7
12
years
0.000118
4
Females
13
50
years
0.000069
2
4.3
Water
Exposure/
Risk
Pathway
The
diuron
drinking
water
exposure
assessment
was
based
primarily
on
1)
submitted
environmental
fate
studies,
2)
limited
but
targeted
monitoring
data
for
diuron
and
its
degradates,
and
3)
monitoring
data
for
the
parent
only.
Although
monitoring
data
for
the
parent
and
its
degradates
were
not
extensive,
the
29
available
measured
data
were
revealing.
For
example,
monitoring
of
32
lakes
in
Texas
showed
that
diuron
was
the
predominant
contaminate
detected.
Surface
and
ground
water
conclusions
from
these
sources
were
compared
with
simulation
model
predictions.
Monitoring
sources
included
United
States
Geological
Survey
(
USGS)
and
published
literature
(
Drinking
Water
Assessment
for
diuron
and
its
degradates.
Ibrahim
Abdel
Saheb.
March
11,
2001).
There
is
no
Maximum
Contaminant
Level
Goal
(
MCLG)
or
Maximum
Contaminant
Level
(
MCL)
established
by
the
Agency's
Office
of
Water
for
diuron.
Diuron
has
the
potential
to
leach
to
ground
water
and
to
contaminate
surface
waters
through
run
off.
Environmental
fate
data
analyzed
by
EFED
show
that
diuron
is
persistent.
Diuron
is
stable
to
hydrolysis
at
pH's
5,
7,
and
9.
The
calculated
half
lives
in
aqueous
and
soil
photolysis
studies
were
43
and
173
days,
respectively.
The
half
lives
in
aerobic
and
anaerobic
soil
metabolism
studies
were
372
and
1000
days,
respectively.
However,
in
viable
laboratory
aquatic
systems,
degradation
appeared
to
be
accelerated
with
half
lives
of
33
and
5
days
in
aerobic
and
anaerobic
systems,
respectively.
The
predominant
degradate
formed
in
both
the
soil
photolysis
and
aerobic
soil
metabolism
studies
was
DCPMU.
The
only
significant
(>
10
%
of
applied)
degradate
in
the
aerobic
and
anaerobic
aquatic
metabolism
studies
was
MCDMPU.
Diuron
dissipated
from
bare
ground
plots
with
half
lives
ranging
from
73
to
133
days,
and
the
major
degradate
(
MCDMPU)
dissipated
from
the
same
plots
with
half
lives
ranging
from
217
to
1733
days.
Diuron
and
MCDMPU
residues
were
detected
mainly
at
the
upper
15
30
cm
depths
at
all
sites
and
sporadically
detected
below
this
depth.
An
upgradable
adsorption/
desorption/
leaching
study
(
MRID#
44490501)
showed
that
diuron
has
a
low
medium
Koc
(
468
1666).
In
addition,
diuron
has
low
water
solubility
(
42
ppm).
The
degradate
3,4
DCA
is
an
environmental
degradate
common
to
diuron,
linuron,
and
propanil.
EFED
does
not
have
sufficient
fate
and
transport
data
on
3,4
DCA.
In
an
aerobic
soil
metabolism
study
with
the
compound
propanil,
3,4
DCA
had
a
half
life
of
30
days
(
MRID#
41537801),
and
in
a
water
paddy
the
half
life
ranged
from
2
3
days
(
MRID#
42200401,
42200501).
Even
though
these
studies
suggest
that
3,4
DCA
will
not
persist
in
soil
or
water,
3,4
DCA
has
been
detected
often
in
surface
water.
Thus,
more
data
are
needed
to
understand
the
fate
of
this
degradate
in
soil
and
water.
TCAB,
also
a
compound
of
concern
for
human
health
(
see
Section
3.5),
was
identified
as
having
a
minor
presence
in
a
diuron
soil
photolysis
study
(
MRID#
41719302)
with
a
maximum
concentration
of
0.038
ppm.
Surface
Water
Exposure:
EFED
has
targeted,
but,
limited
monitoring
data
on
the
concentrations
of
diuron
and
its
degradates
in
surface
water.
A
study
on
the
occurrence
of
cotton
herbicides
and
insecticides
in
the
Playa
lakes
of
the
high
plains
of
western
Texas
concluded
that
diuron
was
the
major
pesticide
detected
in
water
samples
collected
from
32
lakes
with
a
mean
concentration
of
2.7
ppb.
Diuron
metabolites
(
DCPMU,
DCPU,
and
3,4
DCA)
were
found
in
71%
of
the
samples
analyzed.
The
mean
concentrations
of
these
metabolites
were
0.45
ppb
for
DCPMU,
0.31
ppb
for
3,4
DCA,
and
0.2
ppb
for
DCPU.
In
this
study,
water
samples
30
were
taken
within
two
days
after
diuron
application
to
cotton
in
the
region.
Diuron
usage
on
cotton
in
this
part
of
the
state
reached
an
average
of
$
1.379
lb
ai/
mile/
yr.
Even
though,
the
monitoring
of
diuron
concentrations
from
use
on
cotton
in
this
part
of
the
state
is
an
example
of
a
targeted
study,
the
frequency
of
surface
water
sampling
and
the
length
of
the
sampling
period
were
insufficient
to
satisfy
the
temporal
and
spatial
requirements
for
regulatory
purposes.
This
study
has
limited
use
in
a
national
assessment
because
EFED
does
not
expect
western
Texas
to
be
one
of
the
most
vulnerable
use
areas
for
runoff.
However,
because
the
samples
were
taken
within
two
days
after
application,
the
results
may
represent
a
lower
bound
of
possible
peak
concentrations
that
could
occur
in
drinking
water
in
that
area.
The
USGS
National
Water
Quality
Assessment
Program
(
NAWQA)
collected
1420
surface
water
samples
from
62
agricultural
stream
sites
during
the
period
from
1992
1998.
Sampling
was
for
the
parent
only.
One
to
two
samples
were
collected
each
month
throughout
the
year
during
periods
when
pesticide
transport
in
the
streams
was
expected
to
be
low.
At
most
sites,
the
sampling
frequency
was
increased
to
1
to
3
samples
per
week
during
periods
when
elevated
levels
of
pesticides
were
expected
in
the
streams.
Diuron
was
detected
in
7.32%
of
the
samples
(
detection
limit
=
0.05
ppb)
with
an
average
concentration
of
0.13
ppb
in
95%
of
samples.
The
maximum
concentration
of
diuron
was
13
ppb
(
estimated
concentration).
The
monitoring
data,
though
useful
in
a
limited
capacity,
are
either
not
nationally
representative
or
did
not
monitor
for
any
of
the
degradates
and
would
underestimate
potential
drinking
water
exposures.
Therefore,
EFED
calculated
estimated
exposure
concentrations
(
EEC)
in
surface
waters
employing
Tier
II
surface
water
modeling
using
the
Index
Reservoir
(
IR)
and
Percent
Crop
Area
(
PCA)
modifications
to
PRZM
and
EXAMS.
The
IR
represents
a
potential
vulnerable
drinking
water
source
from
a
specific
area
(
Illinois)
with
specific
cropping
patterns,
weather,
soils,
and
other
factors.
The
PCA
is
a
generic
watershed
based
adjustment
factor
which
represents
the
portion
of
a
watershed
planted
to
a
crop
or
crops
and
will
be
applied
to
pesticide
concentrations
estimated
for
the
surface
water
component
of
the
drinking
water
exposure
assessment.
The
IR
PCA
PRZM/
EXAMS
model
was
used
to
determine
estimated
surface
water
concentrations
of
diuron
and
its
degradates
DCPMU,
DCPU,
3,4
DCA,
and
N'(
3
chlorophenyl)
N
N
dimethylurea
(
MCPDMU).
Modeling
results
are
shown
in
Table
9.
The
modeled
concentrations
are
higher
(
9
100
times)
than
the
levels
found
in
existing
surface
water
monitoring
data
targeted
to
pesticide
use
areas.
Ground
Water
Exposure:
EFED
has
limited
targeted
monitoring
data
on
the
concentrations
of
diuron
and
its
degradates
in
groundwater.
Table
8
shows
validated
monitoring
data
for
diuron
that
were
collected
for
the
states
of
California
(
CA),
Florida
(
FL),
Georgia
(
GA),
and
Texas
(
TX)
from
1971
1991.
Table
8.
Groundwater
monitoring
data
for
diuron
(
USEPA
1992).
Number
of
wells
sampled
(
number
of
wells
with
residues).
State
number
of
well
(
detections)
range
of
conc.
(
ppb)
31
CA
2010
(
82)
0.05
3.95
FL
15385
(
9)
1.18
5.37
GA
70
(
67)
1.00
5.00
TX
31
(
2)
0.01
0.02
According
to
the
Ground
Water
Protection
Section
of
the
Florida
Department
of
Environmental
Protection,
ground
water
samples
collected
from
wells
between
May/
1990
and
November/
1997,
showed
diuron
detections
ranging
from
0.94
12
ppb
(
detection
limit
=
0.48
ppb).
The
arithmetic
mean
concentration
was
2.44
ppb.
Well
water
samples
were
collected
from
the
following
counties:
Highlands,
Jackson,
Lake,
Orange,
and
Polk.
With
the
exception
of
the
12
ppb
sample
in
Orange
County,
the
majority
of
the
detections
were
in
Highlands
County
where
citrus
is
grown.
Diuron
concentrations
in
Highlands
County
decreased
with
time
to
about
1
ppb
but
were
detected
every
year.
In
Polk
County,
diuron
concentrations
showed
a
seasonal
pattern,
with
the
highest
concentrations
in
the
spring
and
lowest
concentrations
in
the
fall,
but
it
was
not
detected
in
all
years.
The
USGS
NAWQA
analyzed
pesticide
occurrence
and
concentrations
for
major
aquifers
and
shallow
ground
water
in
agricultural
areas
(
detection
limit
=
0.05
ppb).
Analysis
of
2608
samples
(
major
aquifers
study)
showed
diuron
in
71%
of
the
samples
analyzed
with
a
maximum
concentration
of
0.34
ppb.
The
maximum
diuron
concentration
in
897
samples
from
shallow
groundwater
sites
was
2.0
ppb,
with
diuron
detected
in
only
1.23%
of
samples
analyzed
(
USGS,
1998).
A
major
component
of
the
sampling
design
in
the
NAWQA
study
was
to
target
specific
watersheds
and
shallow
ground
water
areas
that
are
influenced
primarily
by
a
single
dominant
land
use(
agricultural
or
urban)
that
is
important
in
the
particular
area.
The
ground
water
data
were
primarily
collected
from
a
combination
of
production
and
monitoring
wells.
Even
though
the
ground
water
monitoring
data
collected
by
NAWQA
are
from
sites
considered
typical
for
use
areas,
the
frequency
of
sampling
and
the
length
of
sampling
period
were
not
sufficient
to
represent
the
temporal
and
spatial
requirements
for
regulatory
purposes.
In
addition,
USGS
studies
only
monitored
for
the
parent.
Therefore,
the
Screening
Concentration
in
Groundwater
(
SCI
GROW)
model
was
used
to
estimate
potential
ground
water
concentrations
for
diuron
and
its
degradates.
Modeling
results
are
shown
in
Table
9.
32
Table
9.
Estimated
environmental
concentrations
in
surface
and
ground
water
for
diuron
and
its
degradates
from
diuron
use
on
citrus.
model
EECs
(
F
g/
L)
use(
s)
modeled
PCA
Diuron
DCPM
U
DCPU
3,4
DCA
MCPDMU
one
application
of
diuron
on
citrus
@
9.6
lb
ai/
acre,
ground
application
Default
(
0.87)
Surface
water/
peak
613
130
5.80
0.08
136
Surface
water/
1
10
year
average
128
27.0
1.20
0.02
36.4
Surface
water/
mean
of
annual
values
85.0
18.0
0.80
0.01
25.5
Groundwater/
(
peak
and
long
term
average)
6.5
2.50
0.1
2X10
4
1.38
The
IR
PCA
modeling
results
indicate
that
diuron
and
its
degradates
have
the
potential
to
contaminate
surface
waters
by
runoff
in
areas
with
large
amounts
of
annual
rainfall.
Modeling
results
(
EECs)
were
several
orders
of
magnitude
(
ranging
from
9
100
times)
higher
than
diuron
surface
water
monitoring
data
from
known
pesticide
use
areas.
Though
environmental
metabolism
studies
indicate
that
MCPDMU
is
an
environmental
degradate
of
diuron,
it
either
was
not
detected
in
any
of
the
monitoring
studies
or
the
researchers
did
not
look
for
it.
Since
EFED
lacks
complete
environmental
fate
data
(
such
as
the
aerobic
aquatic
and
anaerobic
aquatic
studies)
on
any
of
the
degradates,
the
EECs
for
surface
and
ground
water
were
based
on
half
lives
that
were
calculated
on
cumulative
residues
(
Drinking
Water
Assessment
for
diuron
and
its
degradates.
Ibrahim
Abdel
Saheb.
March
11,
2001).
4.4
Residential
Exposure/
Risk
Pathway
4.4.1
Home
Uses
There
are
potential
residential
exposures
from
activities
associated
with:
1)
pond
and
aquarium
use
and
2)
paint
use.
Though
there
are
existing
labels
for
applications
of
granular
formulations
of
diuron
to
turf,
most
are
limited
to
industrial
and
non
crop
uses.
Others
(
reg.
#
33560
46
and
#
802
352)
are
either
pending
cancellation
by
the
registrant
or
the
registrant
has
agreed
to
place
language
specifically
restricting
residential
uses
on
the
label.
Therefore,
with
these
actions
by
the
registrants
of
the
labels
mentioned
above,
no
residential
turf
uses
exist
for
diuron
and
a
residential
assessment
for
turf
was
not
conducted
(
Occupational
and
Residential
Exposure
Assessment
and
Recommendations
for
the
Reregistration
Eligibility
Decision
Document
for
Diuron.
Renee
Sandvig
and
Christina
Jarvis.
October
16,
2001).
Pond
and
Aquarium
Use
Three
diuron
products
are
designed
for
residential
use
as
algaecide
in
ponds
and
aquariums
and
are
being
supported
for
reregistration.
They
are
Pond
Block
(
0.51%
ai,
reg.
#
33034
1)
and
No
More
33
Algae
(
0.67%
ai,
reg.
#
33034
2),
which
are
both
in
tablet/
block
form,
and
No
More
Algae
(
0.67%
ai,
reg.
#
33034
3),
which
is
in
ready
to
use
liquid
form.
No
exposure
data
exist
for
the
use
of
the
algaecide
tablets/
blocks.
Since
the
products
are
formulated
as
tablets/
blocks
and
dissolve
in
less
than
5
minutes,
minimal
exposure
is
expected
and
was
not
quantified.
Furthermore,
exposure
from
the
block/
tablet
forms
of
diuron
are
expected
to
be
less
than
exposure
from
the
liquid
formulation,
since
spillage
may
occur
from
measuring
and
pouring
liquid
diuron.
The
No
More
Algae
liquid
is
used
at
a
rate
of
one
teaspoon
(
5
ml)
for
every
10
gallons
of
aquarium
or
pond
water.
Treatment
should
be
repeated
once
a
month
or
when
algae
growth
reappears.
Residential
exposure
may
result
from
measuring
the
liquid
and
pouring
the
liquid
into
the
aquarium
or
pond.
Unit
exposure
data
from
the
Pesticide
Handlers
Exposure
Database
(
PHED)
for
the
mixing/
loading
of
liquids
will
be
used
to
assess
this
exposure.
Dermal
exposure
for
noncancer
risk
estimates
was
not
calculated,
since
no
toxicity
by
the
dermal
route
is
expected
for
this
duration.
Exposure
is
expected
to
be
short
term
(
1
to
30
days).
Paint
Use
Antimicrobial
exposures
to
handlers
are
defined
by
the
Antimicrobial
Division
(
OPP/
EPA)
as
"
primary"
and
"
secondary"
handlers.
The
primary
handlers
are
defined
as
those
individuals
exposed
to
the
formulated
product
(
adding
the
diuron
product
into
vats
of
paint
during
its
manufacturing),
while
the
secondary
handlers
are
those
individuals
exposed
to
the
active
ingredient
as
a
direct
result
of
its
incorporation
into
an
end
use
product
(
individuals
using
the
caulk
or
paint
that
in
itself
is
not
a
registered
pesticidal
product).
HED
has
identified
and
assessed
the
primary
handlers
as
those
individuals
who
mix
and
load
diuron
formulation
at
the
manufacturing
facility
for
use
as
a
mildewcide
in
adhesives,
caulks,
sealants,
and
paints.
The
secondary
handlers
are
commercial
and
residential
applicators
who
apply
adhesives,
caulks,
sealants,
and
paints.
Since
diuron
is
only
added
during
the
manufacturing
process,
only
the
secondary
handler
use
(
application
of
the
products
containing
diuron)
was
assessed
in
the
residential
assessment.
No
handler
exposure
data
have
been
submitted
to
determine
the
extent
of
these
exposures.
Secondary
residential
handlers
were
assessed
using
an
airless
sprayer
and
a
paint
brush.
Unit
exposure
data
used
to
assess
the
exposure
resulting
from
applying
paint
containing
diuron
with
an
airless
sprayer
and
a
paintbrush
were
taken
from
a
previous
chlorothalonil
assessment
(
Revised
Occupational
and
Residential
Exposure
Assessment
for
the
Chlorothalonil
Reregistration
Eligibility
Decision
(
RED).
Jeff
Evans.
January
22,
1997).
This
assessment
used
data
from
a
proprietary
worker
exposure
study
conducted
on
the
use
of
chlorothalonil
in
paint.
These
data
were
merged
with
data
contained
in
PHED
to
increase
the
number
of
replicates
and
the
quality
of
the
unit
exposure
data.
The
surrogate
chlorothalonil
study
data
are
assumed
to
be
representative
of
the
exposure
from
the
use
of
diuron
using
the
same
equipment,
since
the
two
chemicals
are
formulated
together
in
three
out
of
the
four
currently
registered
diuron
paint
products.
The
clothing
and
personal
protective
equipment
(
PPE)
scenarios
for
each
type
of
exposure
reflect
the
clothing
and
PPE
worn
in
the
study
from
which
the
unit
exposure
values
were
derived.
The
clothing
worn
in
the
chlorothalonil
assessment
were
long
pants
and
long
34
sleeved
shirt,
which
are
different
from
the
short
sleeved
and
short
pants
clothing
normally
considered
possible
for
residential
exposures.
Therefore,
for
comparison,
data
representing
both
clothing
scenarios
(
long
sleeves
and
long
pants,
as
well
as
short
sleeves
and
short
pants)
were
also
included
in
the
assessment
for
the
application
of
paint
with
an
airless
sprayer
and
a
paint
brush/
roller.
Although
there
is
potential
exposure
during
the
application
of
the
other
treated
materials
(
e.
g.,
caulks
and
sealants),
they
were
not
included
in
this
assessment
because
no
data
are
available
to
assess
these
uses.
There
is
also
a
potential
for
exposure
from
applying
paint
with
a
roller.
It
is
HED's
professional
judgement
that
the
airless
sprayer
and
paintbrush
scenarios
represent
the
high
end
exposures
for
diuron
antimicrobial
secondary
uses
and
therefore,
would
likely
be
protective
of
the
exposures
from
caulk
and
sealant
uses
and
painting
with
a
roller.
No
data
are
available
to
determine
whether
or
not
diuron
contained
in
paint
products
would
be
more
or
less
readily
absorbed
through
the
skin.
35
4.4.1.1
Handler
The
Agency
has
determined
that
there
are
potential
exposures
to
residential
mixers,
loaders,
and
applicators
during
the
usual
use
patterns
associated
with
diuron.
Based
on
the
use
patterns,
five
major
residential
exposure
scenarios
were
identified
for
diuron:
(
1)
Loading
ready
to
use
liquids;
(
2)
Applying
paints/
stains
with
a
paintbrush;
(
3)
Applying
paints/
stains
with
a
paintbrush
(
study
data);
(
4)
Applying
paints
with
an
airless
sprayer;
and
(
5)
Applying
paints
with
an
airless
sprayer
(
study
data).
In
addition
to
diuron's
mildewcide
use
in
paints
and
stains,
it
is
also
used
in
plaster,
stuccos,
sealants,
caulking,
and
fillers.
Unit
exposure
data
only
exists
for
the
use
of
paints/
stains
with
airless
sprayer
and
paintbrush.
These
exposure
scenarios
are
assumed
to
have
a
higher
exposure
than
the
use
of
diuron
in
plaster,
stucco,
sealants,
caulking
and
fillers,
since
less
material
would
be
applied
in
a
day.
Therefore,
the
paint/
stain
assessment
is
considered
protective
for
exposure
resulting
from
the
use
of
diuron
in
plaster,
stucco,
sealants,
caulking,
and
fillers.
The
exposures
to
residential
secondary
handlers
are
expected
to
be
of
a
short
term
duration
(
less
than
30
days).
For
homeowners,
the
airless
sprayer
is
assumed
to
be
used
for
outdoor
applications
only.
Homeowner
use
of
diuron
treated
paint
indoors
is
restricted
to
small
rooms
such
as
bathrooms,
laundry
rooms,
etc.
where
the
use
of
an
airless
sprayer
is
unlikely
to
occur.
For
the
cancer
risk
assessment,
homeowners
applying
diuron
treated
paint
are
assumed
to
be
exposed
two
days
per
year,
which
is
considered
a
high
end
assumption.
Short
term
Exposure/
Risk
Table
10
presents
the
short
term
(
1
30
days)
dermal
and
inhalation
exposures
at
baseline
as
well
as
the
risk
assessments
for
the
inhalation
exposures.
No
systemic
toxicity
was
seen
following
repeated
dermal
dosing
in
the
dermal
toxicity
study
therefore,
no
quantitative
assessment
of
risk
by
the
dermal
route
is
required.
No
PPE
or
engineering
controls
are
assumed
for
residential
exposures.
Residential
handlers
are
assumed
to
be
wearing
short
sleeved
shirts
and
short
pants.
The
short
term
risk
assessment
incorporated
a
NOAEL
of
10
mg/
kg/
day
for
noncancer
inhalation
exposures
and
had
an
LOC
or
target
MOE
of
100,
including
the
1x
FQPA
factor.
The
calculations
of
short
term
inhalation
risk
indicate
that
the
inhalation
MOEs
are
more
than
100
at
the
baseline
level
for
the
all
the
assessed
exposure
scenarios
and
are
not
considered
risks
of
concern.
Cancer
Exposure/
Risk
To
assess
cancer
risk,
an
average
daily
dose,
a
lifetime
daily
dose
and
a
total
cancer
risk
are
calculated.
For
the
cancer
assessment,
potential
dermal
exposure
was
included
with
a
high
end
dermal
absorption
factor
(
measured
from
a
submitted
study)
of
4%.
Assumptions
included
in
the
calculations
were
an
average
adult
lifetime
of
70
years
and
an
exposure
duration
of
50
years.
The
number
of
exposures
per
year
for
the
pond
and
aquarium
uses
are
based
on
the
label
recommendations.
The
"
No
More
Algae"
liquid
label
states
that
"
For
regular
maintenance,
use
once
a
month
or
as
algae
starts
to
36
reappear."
Therefore,
12
exposures
per
year
were
assumed.
Homeowners
applying
diuron
treated
paint
are
exposed
two
days
per
year.
Since
it
would
be
unusual
for
a
homeowner
to
paint
their
house
every
year
with
diuron
treated
paint,
this
is
considered
a
high
end
estimate.
Cancer
risks
equal
to
or
less
than
1
x
10
6
are
not
considered
to
be
of
concern.
Risks
greater
than
1
x
10
6
for
the
general
population
are
considered
to
be
of
concern.
The
residential
cancer
risk
assessment
was
conducted
using
the
diuron
Q1*
of
1.91
x
10
2
and
is
summarized
in
Table
11.
The
following
scenarios
have
cancer
risks
greater
than
1
x
10
6
at
the
baseline
level
of
exposure
(
bracketed
numbers
can
be
matched
to
the
exposure
scenarios
in
the
tables):
(
2)
Applying
paints/
stains
with
a
paint
brush;
(
3)
Applying
paints/
stains
with
a
paint
brush
(
study
data)
for
stains;
(
4)
Applying
paint
with
an
airless
sprayer;
and
(
5)
Applying
paint
with
an
airless
sprayer
(
study
data).
The
following
scenarios
have
cancer
risks
less
than
1
x
10
6
at
the
baseline
level
of
exposure:
(
1)
Loading
ready
to
use
liquids
for
ponds
and
aquariums
All
scenarios
were
assessed
at
the
maximum
rate
of
application.
Average
application
rate
for
the
paint
use
is
unknown
and
is
requested
to
refine
this
risk.
The
residential
cancer
risk
is
considered
conservative
since
an
upper
bound
dermal
absorption
rate
was
used
(
no
dermal
penetration
study
was
submitted),
coupled
with
maximum
application
rates.
4.4.1.2
Postapplication
Postapplication
inhalation
and
dermal
exposure
resulting
from
the
use
of
diuron
in
ponds
and
aquariums
is
expected
to
be
minimal.
Diuron
is
applied
to
ponds/
aquariums
in
the
form
of
a
liquid
and
an
effervescent
tablet.
Due
to
the
high
dilution
rate
of
the
liquid
in
pond
and
aquarium
water
(
0.0000074
lb
ai
per
gallon
of
water),
and
the
effervescent
nature
of
the
tablet
(
expected
to
dissolve
in
less
than
five
minutes),
postapplication
exposure
to
diuron
in
pond
and
aquarium
water
is
expected
to
be
minimal.
Furthermore,
postapplication
activities
in
and
around
ponds/
aquariums
treated
with
diuron
are
assumed
to
be
infrequent.
Postapplication
inhalation
and
dermal
exposure
resulting
from
the
indoor
use
of
diuron
in
paints
is
also
expected
to
be
minimal.
The
Agency
has
conducted
a
screening
level
inhalation
assessment
using
the
Multi
Chamber
Concentration
and
Exposure
Model
(
MCCEM).
MCCEM
uses
air
infiltration
and
37
interzonal
air
flow
rates,
together
with
user
inputs
for
emission
rates,
decay
rates,
and
outdoor
concentrations
to
calculate
time
varying
indoor
concentrations
and
associated
indoor
inhalation
exposure
due
to
product
or
material
emissions
in
several
zones
or
chambers
within
a
residence.
The
results
of
this
model,
coupled
with
diuron's
low
vapor
pressure
(
2
x
10
7
mm
Hg
at
30
E
C),
show
minimal
postapplication
inhalation
exposure.
Furthermore,
diuron
treated
paint
is
only
likely
to
be
used
in
rooms
where
high
humidity
is
expected
(
i.
e.
a
bathroom),
and
would
rarely
be
used
in
the
entire
house.
It
is
unlikely
that
a
homeowner
would
receive
a
significant
amount
of
postapplication
inhalation
exposure
from
diuron
treated
paint,
as
the
very
nature
of
its
use
is
as
a
mildewcide,
and
any
substantial
loss
of
the
active
ingredient
from
the
paint
would
render
the
product
ineffective.
4.4.2
Recreational
There
are
no
recreational
use
sites
for
diuron.
4.4.3
Other
(
Spray
Drift;
Farm
Worker
Children,
etc.)
Spray
drift
is
always
a
potential
source
of
exposure
to
residents
nearby
to
spraying
operations.
This
is
particularly
the
case
with
aerial
application,
but,
to
a
lesser
extent,
could
also
be
a
potential
source
of
exposure
from
groundboom
application
methods.
The
Agency
has
been
working
with
the
Spray
Drift
Task
Force,
EPA
regional
offices
and
state
lead
agencies
for
pesticide
regulation
and
other
parties
to
develop
the
best
spray
drift
management
practices.
The
Agency
is
now
requiring
interim
mitigation
measures
for
aerial
applications
that
must
be
placed
on
product
labels/
labeling.
The
Agency
has
completed
its
evaluation
of
the
new
data
base
submitted
by
the
Spray
Drift
Task
Force,
of
which
U.
S.
pesticide
registrants
are
members,
and
is
developing
a
policy
on
how
to
appropriately
apply
the
data
and
the
AgDRIFT
computer
model
to
its
risk
assessments
for
pesticides
applied
by
air,
orchard
airblast
and
ground
hydraulic
methods.
After
the
policy
is
in
place,
the
Agency
may
impose
further
refinements
in
spray
drift
management
practices
to
reduce
off
target
drift
and
risks
associated
with
aerial
as
well
as
other
application
types,
where
appropriate.
38
Table
10:
Residential
Short
Term
Baseline
Table
Exposure
Scenario
(
Scenario
#)
Dermal
Unit
Exposure
(
mg/
lb
ai)
a
Inhalatio
n
Unit
Exposure
(
F
g/
lb
ai)
b
Data
Source
Site/
Use
Application
Ratec
Amount
Treatedd
Dermal
Dosee
Inhalation
Dose
(
mg/
kg/
day)
f
Inhalation
MOEg
Mixer/
Loader
Loading
Ready
to
Use
Liquids
(
1)
2.9
1.2
PHED
V1.1
Pond
0.0000074
lb
ai
per
gallon
3000
Gallons
per
day
0.00092
0.00000038
26,000,000
PHED
V1.1
Pond
0.0000074
lb
ai
per
gallon
1000
Gallons
per
day
0.00031
0.00000013
79,000,000
PHED
V1.1
Aquarium
0.0000074
lb
ai
per
gallon
50
Gallons
per
day
0.000015
0.0000000063
1,600,000,000
Applicator
Applying
Paint/
Stains
with
Paintbrush
(
2)
230
280
PHED
V1.1
Paint
0.0532
lb
ai
per
gallon
2
Gallons
per
day
0.35
0.00043
23,000
PHED
V1.1
Stain
0.0532
lb
ai
per
gallon
5
Gallons
per
day
0.87
0.0011
9,400
Applying
Paint/
Stains
with
Paintbrush
(
study
data)
(
3)
290
507
Chlorothalonil
Study/
PHED
Paint
0.0532
lb
ai
per
gallon
2
Gallons
per
day
0.44
0.00077
13,000
Chlorothalonil
Study/
PHED
Stain
0.0532
lb
ai
per
gallon
5
Gallons
per
day
1.1
0.0019
5,200
Applying
Paint
with
Airless
Sprayer
(
4)
79
830
PHED
V1.1
Paint
0.0532
lb
ai
per
gallon
15
Gallons
per
day
0.90
0.0095
1,100
Applying
Paint
with
Airless
Sprayer
(
study
data)
(
5)
33.33
433
Chlorothalonil
Study/
PHED
Paint
0.0532
lb
ai
per
gallon
15
Gallons
per
day
0.38
0.0049
2,000
Footnotes:
a
Baseline
dermal
exposure
represents
short
pants,
short
sleeves
and
no
gloves,
except
for
the
chlorothalonil
study,
MRID
43600102,
which
represent
long
pants,
long
sleeved
shirts
and
no
gloves.
b
Baseline
inhalation
unit
exposure
represents
no
respirator.
c
Application
rates
are
based
on
the
maximum
application
rates
listed
on
the
"
No
More
Algae"
liquid
label
and
paint
labels.
d
Amount
treated
per
day
are
from
EPA
estimates
of
average
aquarium
and
pond
size
and
the
maximum
pond
size
listed
on
the
label.
Paint/
stain
assumptions
are
from
Expo
SAC
39
policy
#
12.15
e
Daily
Dermal
Dose
(
mg/
kg/
day)
=
(
Dermal
Unit
Exposure
(
mg/
lb
ai)
x
Application
Rates
(
lb
ai/
A
and
lb
ai/
sq.
ft.)
x
Area
Treated
per
day
(
acres
and
square
feet))/
body
weight
(
70
kg).
f
Daily
Inhalation
dose
(
mg/
kg/
day)
=
(
Inhalation
Unit
Exposure
(
F
g/
lb
ai)
x
(
1mg/
1000
F
g)
Conversion
Factor
x
Application
Rate
(
lb
ai/
gallon)
x
Amount
Treated
per
day
(
gallons/
day))/
body
weight
(
70
kg).
g
Short
term
Inhalation
MOE
=
Inhalation
NOAEL
(
10
mg/
kg/
day)
/
Daily
Inhalation
Dose
(
mg/
kg/
day).
40
Table
11:
Residential
Cancer
(
Q*)
Risk
Table
Exposure
Scenario
(
Scenario
#)
Use
site
Application
Rate
Amount
Treated
Total
Daily
Dosea
Baseline
Daily
LADDb,
c
Baseline
Riskd
Mixer/
Loader
(
12
days/
year)
Loading
Ready
to
Use
Liquids
(
1)
pond
0.0000074
lb
ai
per
gallon
3000
Gallons
per
day
0.000037
8.7
E
7
1.7
E
8
pond
0.0000074
lb
ai
per
gallon
1000
Gallons
per
day
0.000012
2.9
E
7
5.5
E
9
aquarium
0.0000074
lb
ai
per
gallon
50
Gallons
per
day
0.00000062
1.5
E
8
3.0
E
10
Applicator
(
2
days/
year)
Applying
Paint/
Stains
with
Paintbrush
(
2)
Paint
0.0532
lb
ai
per
gallon
2
Gallons
per
day
0.014
5.5
E
5
1.1
E
6
Stains
0.0532
lb
ai
per
gallon
5
Gallons
per
day
0.036
1.4
E
4
2.7
E
6
Applying
Paint/
Stains
with
Paintbrush
(
study
data)
(
3)
Paint
0.0532
lb
ai
per
gallon
2
Gallons
per
day
0.018
5.0
E
5
9.5
E
7
Stains
0.0532
lb
ai
per
gallon
5
Gallons
per
day
0.046
1.3
E
4
2.4
E
6
Applying
Paint
with
Airless
Sprayer
(
4)
Paint
0.0532
lb
ai
per
gallon
15
Gallons
per
day
0.045
1.8
E
4
3.4
E
6
Applying
Paint
with
Airless
Sprayer
(
study
data)
(
5)
Paint
0.0532
lb
ai
per
gallon
15
Gallons
per
day
0.020
5.5
E
5
1.1
E
6
Footnotes:
a
Total
Daily
Dose
(
mg/
kg/
day)
=
Daily
Dermal
Dose
(
mg/
kg/
day)
*
Dermal
Absorption
(
4%)
+
Daily
Inhalation
Dose
(
mg/
kg/
day).
See
Table
10
for
daily
dermal
and
inhalation
doses.
b
The
number
of
exposures
per
year
are
based
on
the
label
recommendations.
The
No
More
Algae
Liquid
label
states
that
"
For
regular
maintenance,
use
once
a
month
or
as
algae
starts
to
reappear."
Therefore,
12
exposures
per
year
were
assumed.
Two
exposures
per
year
assumed
for
residential
person
painting
their
home.
15
c
Lifetime
average
daily
dose
(
LADD)
(
mg/
kg/
day)
=
Total
Daily
Dose
(
mg/
kg/
day)
*
(
number
of
days
of
exposure
per
year
/
365
days/
year)
*
(
50
years
exposed
/
70
years
in
a
lifetime).
d
Cancer
risk
=
LADD
(
mg/
kg/
day)
*
Q1
(
1.91E
2
mg/
kg/
day1).
41
5.0
AGGREGATE
RISK
ASSESSMENTS
AND
RISK
CHARACTERIZATIONS
Risk
is
a
function
of
exposure
multiplied
by
hazard
(
Risk
=
Exposure
x
Hazard).
Exposure
may
be
measured
or
modeled,
depending
on
the
available
data.
Ideally
the
exposure
data
would
be
chemical
specific
occupational
or
residential
monitoring
data,
at
the
tap
drinking
water
data,
and
close
to
theplate
food
residue
data
on
all
crops.
In
the
absence
of
an
ideal
data
set,
surrogate
data,
and
other
factors
are
incorporated
into
the
exposure
assessments
(
dietary
and
non
dietary)
to
present
a
reasonable
exposure
picture
based
on
the
best
available
data.
The
hazard
portion
of
the
risk
equation
has
several
layers
of
safety
built
into
it
to
provide
a
cushion
between
exposure
and
the
dose
at
which
adverse
effects
were
seen
in
an
animal
study.
Generally,
endpoints
are
based
on
the
dose
at
which
no
observable
adverse
effect
is
seen
in
an
animal
study.
This
is
the
No
Observable
Adverse
Effect
Level
(
NOAEL).
The
Lowest
Observable
Adverse
Effect
Level
(
LOAEL)
is
the
next
highest
dose
in
an
animal
study,
up
from
the
NOAEL,
at
which
the
adverse
effect
of
concern
is
seen.
Since
the
toxicity
studies
used
for
endpoint
selection
are
conducted
in
animals,
and
there
are
differences
between
individual
humans,
additional
uncertainty
factors
for
inter
and
intra
species
variability
are
integrated
into
the
hazard
portion
of
the
risk
equation.
Since
the
passage
of
the
FQPA,
an
additional
layer
of
protection
is
factored
in
(
when
appropriate)
to
provide
an
even
greater
safety
cushion
between
exposure
and
toxic
effects
for
particularly
sensitive
populations.
It
is
in
this
light
that
expressions
of
risk
(
risk
numbers)
should
be
viewed
with
an
understanding
that
they
are
not
portrayals
of
imminent
toxic
effects
to
humans
but
as
a
measure
of
the
distance
between
potential
exposure
and
possible
toxic
effects.
In
accordance
with
current
HED
policy
(
effective
03/
11/
99)
the
acute
and
chronic
dietary
endpoints
are
expressed
as
acute
Population
Adjusted
Dose
(
aPAD)
and
chronic
PAD
(
cPAD),
and
no
longer
as
an
adjusted
Reference
Dose
(
RfD).
RfD
=
acute
or
chronic
NOAEL
Uncertainty
Factor
(
UF)
Generally,
an
UF
of
100
is
applied
for
intra
and
inter
species
differences.
PAD
=
acute
or
chronic
RfD
FQPA
factor
The
use
of
the
PAD
will
apply
whether
the
FQPA
factor
is
retained
(
10x
or
3x)
or
not
(
1x).
When
a
PAD
is
used,
such
as
in
the
dietary
assessment,
the
risk
is
expressed
as
a
percentage
of
the
PAD
which
is
equal
to
the
measured
exposure
divided
by
the
PAD
and
then
multiplied
by
100
or:
Risk
(%
PAD)
=
Exposure
x
100
PAD
Occupational,
residential
(
when
applicable),
and
the
aggregate
risk
(
when
appropriate)
will
still
be
42
expressed
as
the
Margin
of
Exposure
(
MOE).
MOE
=
NOAEL
(
mg/
kg/
d
Exposure
(
mg/
kg/
d)
Current
HED
policy
requires
that
FQPA
safety
factors
be
retained
for
dietary
and
non
occupational
exposures,
when
appropriate,
not
occupational
exposures
(
Memorandum,
Special
Report
of
the
FQPA
Safety
Factor
Committee,
B.
Tarplee
and
J.
Rowland,
April
15,
1998).
Therefore,
an
MOE
of
>
100
is
generally
needed
in
the
occupational
exposure
risk
assessment.
For
diuron,
if
there
were
long
term
occupational
exposures
(
none
are
expected)
an
MOE
of
>
300
would
be
needed
since
a
3x
was
factored
in
because
a
LOAEL
was
selected
for
the
endpoint.
Since
the
FQPA
factor
is
1x,
for
residential
uses,
MOEs
>
100/
300
are
also
needed
for
short
and
intermediate
term,
and
long
term
exposures,
respectively.
Generally,
the
Agency
calculates
Drinking
Water
Levels
of
Comparison
(
DWLOC)
for
comparison
to
measured
or
modeled
drinking
water
concentrations
for
the
risk
analysis.
The
DWLOC
is
the
concentration
in
drinking
water,
as
part
of
the
aggregate
exposure,
that
occupies
no
more
than
100%
of
the
PAD.
The
dietary
exposure
from
food
and
DWLOC
together,
cannot
be
greater
than
100%
of
the
PAD.
Any
measured
or
modeled
drinking
water
estimates
that
are
less
than
the
DWLOC
are
not
of
concern.
The
Agency
has
calculated
DWLOCs
for
chronic
(
noncancer)
and
short
term
exposure
to
diuron
and
its
degradates
(
metabolites
hydrolyzable
to
3,4
DCA)
in
surface
and
ground
water
for
the
population
subgroups;
children
1
6
years
(
most
highly
exposed
population),
infants
<
1
year,
females
13
50
years,
and
the
general
U.
S.
population.
No
adverse
effects
attributed
to
a
single
exposure
to
diuron
were
identified
in
any
available
studies.
Therefore,
no
acute
dietary
risk
assessment
was
conducted
and
hence,
no
acute
DWLOC
(
DWLOCacute)
was
calculated.
The
DWLOCcancer
is
the
concentration
in
drinking
water
as
a
part
of
the
aggregate
chronic
exposure
that
results
in
a
negligible
cancer
risk
(
10
6).
Residential
exposures
to
adult
handlers
would
be
factored
into
the
DWLOCcancer;
however,
the
estimated
residential
risks
alone
are
above
the
Agency's
level
of
concern,
therefore,
DWLOCcancer
=
0.
Since
no
systemic
toxicity
was
seen
in
the
dermal
toxicity
study,
no
short
or
intermediate
term
occupational
or
residential
risk
assessment
by
the
dermal
route
was
needed.
The
exception
was
for
the
cancer
assessment,
for
which
the
oral
study
and
a
dermal
absorption
factor
(
measured
from
a
submitted
study)
were
used.
Based
on
the
labeled
uses,
no
incidental
oral
exposures
are
expected.
Due
to
the
lack
of
availability/
submission
of
acceptable/
guideline
inhalation
studies
using
diuron,
occupational
and
residential
risk
assessments
were
conducted
using
endpoints
selected
from
oral
studies.
To
fully
characterize
the
hazard
and
subsequent
potential
risk
from
exposures
to
diuron
and
its
metabolites
a
28
day
inhalation
study
in
rats
is
needed.
43
5.1
Acute
Risk
No
adverse
effects
attributed
to
a
single
exposure
to
diuron
were
identified
in
any
available
studies.
Therefore,
no
acute
dietary
risk
assessment
was
conducted,
no
DWLOCacute
was
calculated,
and
hence,
no
acute
aggregate
risk
was
conducted.
5.2
Short
term
Risk
5.2.1
Aggregate
Short
term
Risk
Assessment
When
potential
food
and
residential
inhalation
exposures
are
combined
they
result
in
aggregate
short
term
MOEs
=
1043
and
1045
for
adult
males
and
females,
respectively,
which
are
not
of
concern.
Based
on
labeled
uses,
no
intermediate
or
long
term
residential
handler,
or
postapplication
exposures
of
any
duration,
are
expected.
Aggregate
short
term
risk
estimates
for
diuron
and
its
metabolites
hydrolyzable
to
3,4
DCA
would
combine
exposures
from
food
(
average),
water,
and
inhalation.
Since
measured
drinking
water
data
(
monitoring
data)
are
limited
and
cannot
be
quantitatively
included
in
the
risk
assessment,
estimates
of
allowable
levels
of
drinking
water
were
calculated
(
see
DWLOCs
below)
instead.
The
Agency
determined
that
it
was
unlikely
that
more
than
one
of
the
residential
handler
activities
would
occur
concurrently
during
a
short
term
time
period.
Therefore,
the
Agency
took
the
protective
approach
of
including
the
exposures
from
the
activity
which
could
potentially
result
in
the
most
exposure
to
the
homeowner,
applying
paint
with
an
airless
sprayer,
in
the
aggregate
assessment.
It
should
be
noted
that
residential
exposures
are
calculated
at
baseline
(
no
personal
protective
equipment,
no
engineering
controls).
The
"
MOE
approach"
was
used
to
calculate
the
short
term
aggregate
risk,
combining
food
and
inhalation
exposures,
and
using
a
NOAEL
of
10
mg/
kg/
day.
A
UF
of
100
(
10x
for
interspecies
extrapolation,
10x
for
intraspecies
variability)
and
the
1x
FQPA
safety
factor
for
diuron
were
applied
to
the
assessment;
therefore,
an
MOE
of
greater
than
100
is
not
of
concern.
5.2.2
Short
term
DWLOC
Calculations
Though
some
limited
chemical
specific
water
monitoring
data
are
available,
they
are
not
nationally
representative
and
not
at
the
tap
data.
Though
they
may
be
indicative
of
surface
water
and
ground
water
levels
of
diuron
and
its
metabolites,
under
very
limited
conditions,
the
Agency
believes
that
they
are
unsuitable
to
be
quantitatively
included
in
aggregate
risk
assessment.
Therefore,
estimated
environmental
concentrations
(
EECs)
were
calculated
by
EFED
to
estimate
the
potential
contribution
to
the
averaged
(
chronic)
exposure
from
drinking
water,
and
the
EECs
were
compared
to
the
short
term
DWLOCs.
44
The
current
Agency
default
body
weight
and
consumption
values
are
10
kg
and
1
liter/
day,
respectively,
for
all
infants
and
children,
70
kg
and
2
liters/
day
for
adult
males,
and
60
kg
and
2
liters/
day
for
adult
females.
These
default
values
and
others
are
presently
under
review
in
the
Agency
(
Office
of
Research
and
Development).
If
at
a
future
time,
the
Agency
decides
to
change
the
default
assumptions
used,
the
impact
of
the
changes
on
the
diuron
risk
assessment
will
be
considered.
The
DWLOCshort
term
is
the
concentration
in
drinking
water,
as
part
of
the
aggregate
exposure,
that
combined
with
average
food
exposures
and
residential
exposures
and
divided
into
the
short
term
NOAEL,
results
in
an
MOE
that
is
greater
than
the
LOC
or
target
MOE.
Any
measured
or
modeled
drinking
water
estimates
that
are
less
than
the
DWLOC
are
not
of
concern.
As
part
of
the
aggregate
risk
assessment
for
diuron,
the
short
term
assessment
was
handled
using
the
reciprocal
MOE
equation
("
1/
MOE
approach")
for
calculating
the
aggregate
MOE
and
solving
for
the
term
MOEwater.
The
reciprocal
MOE
equation
is
only
used
when
the
toxic
effects
on
which
the
endpoints
are
selected
are
the
same
and
when
the
LOCs
are
identical
for
all
MOEs
in
the
calculation.
Based
on
the
supported
uses
of
diuron,
no
incidental
oral
(
hand
to
mouth)
exposures
are
expected
and
therefore,
were
not
factored
into
the
aggregate
and
DWLOC
calculations,
i.
e.
no
exposures
to
children
are
expected.
Also,
no
systemic
toxicity
following
repeated
dermal
dosing
was
observed
in
submitted
studies
therefore,
dermal
exposures
were
not
factored
into
the
equation
either.
Taking
into
account
the
uses
proposed
in
this
action,
the
Agency
can
conclude
with
reasonable
certainty
that
residues
of
diuron
plus
its
metabolites
hydrolyzable
to
3,4
DCA,
resulting
from
applications
of
diuron,
in
drinking
water
would
not
likely
result
in
an
aggregate
short
term
risk
to
male
and
female
adult
homeowners
above
the
Agency's
level
of
concern.
The
Agency
based
this
determination
on
a
comparison
of
estimated
concentrations
of
diuron
and
its
metabolites
(
DCPMU,
DCPU,
3,4
DCA)
in
surface
and
ground
waters
to
back
calculated
"
levels
of
comparison"
for
diuron
plus
its
metabolites
in
drinking
water.
The
EECs
in
surface
and
ground
waters
were
derived
from
water
quality
models
that
used
conservative
assumptions
(
health
protective)
regarding
the
pesticide
transport
from
the
point
of
application
to
surface
or
ground
water,
and
were
supplemented
with
limited
monitoring
data.
Modeled
Tier
2
(
PRZM/
EXAMS)
estimates
of
concentrations
of
diuron
plus
its
metabolites
in
surface
water
were
below
the
short
term
DWLOCs
for
male
and
female
adults
and
are
not
of
concern.
The
EECs
calculated
by
EFED
were
based
on
the
highest
labeled
rate
of
application
for
citrus.
Modeled
Tier
1
SCI
GROW
estimates
of
ground
water
concentrations
of
diuron
plus
its
metabolites
were
below
the
short
term
DWLOCs
and
are
not
of
concern.
45
Table
12.
Aggregate
Short
Term
Risk
and
DWLOC
Calculations
(
Inhalation/
Oral
Endpoints
and
NOAELs
the
Same)
Population
Short
Term
Scenario
NOAEL
mg/
kg/
d
LOC1
Max
Exposure2
mg/
kg/
d
Average
Food
Exposure
mg/
kg/
d
Residential
Exposure3
mg/
kg/
d
Aggregate
MOE
(
food
and
residential)
4
Max
Water
Exposure5
mg/
kg/
d
Surface
Water
EEC6
(
F
g/
L)
Ground
Water
EEC6
(
F
g/
L)
Short
Term
DWLOC7
(
F
g/
L)
Adult
Male
10
100
0.1
0.000088
0.0095
1043
0.09
104
9.1
3153
Adult
Female
10
100
0.1
0.000069
0.0095
1045
0.09
104
9.1
2700
1
LOC
(
Target
MOE)
includes
safety
factors
totaling
100
for
inter
species
extrapolation
(
10x)
and
intra
species
variability
(
10x).
2
Maximum
Exposure
(
mg/
kg/
day)
=
NOAEL/
LOC
3
Residential
Exposure
=
Inhalation
Exposure
4
Aggregate
MOE
=
[
NOAEL
÷
(
Avg
Food
Exposure
+
Residential
Exposure)]
5
Maximum
Water
Exposure
(
mg/
kg/
day)
=
Target
Maximum
Exposure
(
Food
Exposure
+
Residential
Exposure)
6
The
crop
producing
the
highest
level
was
used
to
assess
exposure
to
diuron,
DCPMU,
DCPU,
3,4
DCA,
total.
7
DWLOC(
F
g/
L)
=
[
maximum
water
exposure
(
mg/
kg/
day)
x
body
weight
(
kg)]
[
water
consumption
(
L)
x
10
3
mg/
F
g]
5.4
Chronic
Risk
5.4.1
Chronic
Aggregate
Risk
Assessment
Aggregate
chronic
(
noncancer)
risk
estimates
include
the
contribution
of
risk
from
dietary
sources
(
food
+
water)
and
residential
sources.
However,
based
on
the
labeled
uses,
no
long
term
or
chronic
residential
exposures
are
expected.
Chronic
risk
estimates
from
exposures
to
food,
associated
with
the
use
of
diuron
do
not
exceed
the
Agency's
level
of
concern
for
the
most
highly
exposed
population
subgroup,
children
ages
1
6
years
of
age.
The
chronic
dietary
(
food
only)
risk
estimate
for
children
ages
1
6
years
of
age
was
<
7%
of
the
chronic
PAD.
As
mentioned
above,
though
some
limited
chemical
specific
water
monitoring
data
are
available,
they
are
not
nationally
representative
and
not
at
the
tap
data.
Therefore,
EECs
were
calculated
by
EFED
to
estimate
the
potential
contribution
to
the
chronic
exposure
from
drinking
water,
and
the
EECs
were
compared
to
the
chronic
DWLOCs.
5.4.2
Chronic
DWLOC
Calculations
To
calculate
the
DWLOC
for
chronic
(
noncancer)
exposure
relative
to
a
chronic
toxicity
endpoint,
the
dietary
food
exposure
(
from
DEEM
)
was
subtracted
from
the
PAD
to
obtain
the
exposure
to
46
diuron
and
its
3,4
DCA
containing
metabolites
in
drinking
water
that
would
not
be
of
concern.
A
chronic
DWLOC
(
DWLOCchronic)
was
calculated
using
the
following
formulae:
DWLOCchronic
(
µ
g/
L)
=
chronic
water
exposure
(
mg/
kg/
d)
x
body
weight
(
kg)
consumption
(
L/
d)
x
10
3
mg/
µ
g
chronic
water
exposure
(
mg/
kg/
d)
=
[
cPAD
(
chronic
food
+
residential(
ADD)(
mg/
kg/
d))]
Where
ADD
=
average
daily
dose
Residential
exposures
were
not
factored
into
the
DWLOCchronic
since
no
long
term
residential
exposures
(
handler
or
postapplication)
are
expected.
Taking
into
account
the
uses
proposed
in
this
action,
the
Agency
cannot
conclude
with
reasonable
certainty
that
residues
of
diuron
plus
its
metabolites
hydrolyzable
to
3,4
DCA,
resulting
from
applications
of
diuron,
in
drinking
water
would
not
likely
result
in
a
chronic
dietary
risk
to
infants,
children,
and
adults
above
the
Agency's
level
of
concern.
The
Agency
based
this
determination
on
a
comparison
of
estimated
concentrations
of
diuron
and
its
metabolites
in
surface
waters
to
backcalculated
"
levels
of
comparison"
for
diuron
plus
its
metabolites
in
drinking
water.
Modeled
Tier
2
(
PRZM/
EXAMS)
estimates
of
concentrations
of
diuron
plus
its
metabolites
(
DCPMU,
DCPU,
3,4
DCA)
in
surface
water
were
above
the
chronic
DWLOCs
for
all
population
subgroups
and
are
of
concern
(
Table
13).
The
EECs
calculated
by
EFED
were
based
on
the
highest
labeled
rate
of
application
for
citrus.
Modeled
Tier
1
SCI
GROW
estimates
of
ground
water
concentrations
of
diuron
plus
its
metabolites
(
DCPMU,
DCPU,
3,4
DCA)
were
below
the
chronic
DWLOCs
and
are
not
of
concern.
Table
13
Summary
of
Chronic
DWLOC
Calculations
Population
Subgroups
cPAD
mg/
kg/
d
Food
Exposure
mg/
kg/
d
Maximum
Water
Exposure
mg/
kg/
d
PRZM/
EXAMS
(
ppb)
surface
water
(
total
EECs)
SCI
GROW
(
ppb)
ground
water
(
total
EECs)
DWLOCchronic
(
ppb)
U.
S.
Population
0.003
0.000088
0.0029
104
9.1
102
Females
13
50
yrs
0.003
0.000069
0.0029
104
9.1
88
Infants
<
1
yr
0.003
0.000077
0.0029
104
9.1
29
47
Children
1
6
yrs
0.003
0.00020
0.0028
104
9.1
28
5.5
Cancer
Risk
5.5.1
Aggregate
Cancer
Risk
Assessment
Though
estimated
exposure
to
food
alone
results
in
a
cancer
risk
(
1.68
x
10
6)
for
the
U.
S.
general
population,
it
is
not
of
concern.
The
estimates
of
exposures
from
food
are
based
on
a
refined
analysis
(%
CT
and
some
processing
data),
but
used
data
from
field
trails
conducted
at
the
maximum
application
rates
and
cannot
be
further
refined
without
additional
data
(
processing
data,
monitoring
data
that
includes
the
parent
and
its
metabolites
that
are
hydrolyzable
to
3,4
DCA).
Residential
exposures
to
applicators
(
adults)
applying
paint
with
a
paintbrush
or
airless
sprayer
result
in
potential
cancer
risks
that
are
of
concern
(
range
1.9
x
10
6
to
6.8
x
10
6).
This
is
a
conservative
assessment
based
on
Residential
SOPs
and
includes
an
estimate
of
dermal
exposure
and
an
upper
bound
dermal
absorption
factor.
Residential
exposures
to
homeowners
loading
ready
to
use
liquids
do
not
result
in
potential
cancer
risks
that
are
of
concern.
5.5.2
Cancer
DWLOC
Calculations
For
the
cancer
(
Q1*)
exposure
calculations,
the
Agency
uses
a
multi
year
mean
water
concentration
values.
The
DWLOCcancer
is
the
concentration
in
drinking
water
as
a
part
of
the
aggregate
chronic
exposure
that
results
in
a
negligible
cancer
risk
(
10
6).
Residential
exposures
to
adult
handlers
would
be
factored
into
the
DWLOCcancer
however,
since
the
potential
cancer
risks
from
exposures
during
residential
activities,
alone,
are
of
concern,
no
DWLOCs
were
calculated
and
allowable
exposures
to
water
are
essentially
"
0."
5.5.3
Additional
Cancer
Risks
The
MARC
recommended
that
a
separate
dietary
cancer
assessment
be
conducted
for
MCPDMU,
a
potential
residue
of
concern
in
water,
but
not
found
in
plant
or
animal
residue
studies.
The
MARC
raised
concerns
for
N'(
3
chlorophenyl)
N,
N
dimethyl
urea
(
MCPDMU)
based
on
an
analogous
compound,
N'(
4
chlorophenyl)
N,
N
dimethyl
urea
(
monuron).
With
the
exception
of
the
position
of
the
chlorine,
the
structures
are
identical.
There
are
cancer
concerns
for
monuron
but
the
target
organs
are
different
than
those
affected
by
diuron.
Monuron
produces
kidney
and
liver
tumors
in
male
rats
(
NTP
technical
Report
266,
1988).
The
most
potent
unit
risk,
Q1
*
of
those
calculated
for
monuron
is
that
for
male
rat
liver
neoplastic
nodule
and/
or
carcinoma
combined
tumor
rates
at
1.52
x
10
2
(
mg/
kg/
day)
1,
in
human
equivalents
(
MONURON:
Quantitative
Risk
Assessment
(
Q1
*)
Based
On
F344/
N
Rat
Dietary
Study
With
3/
4'
s
Interspecies
Scaling
Factor.
PC
Code
035501.
Lori
L.
Brunsman.
July
5,
2001).
48
Since
there
is
potential
for
MCPDMU
to
occur
in
water,
the
Agency
considered
possible
exposures
to
MCPDMU
from
ingestion
of
catfish,
as
well
as
from
drinking
water.
The
AR
of
MCPDMU
in
catfish
was
calculated
using
the
following
inputs:
2
ppm
tolerance
for
catfish
x
0.251
x
0.352
=
anticipated
residue
Where:
1
The
fraction
of
applied
radioactive
diuron
converted
to
MCPDMU
in
an
aerobic
aquatic
metabolism
study
(
see
EFED
chapter).
The
data
were
obtained
from
a
sample
taken
30
days
after
initiation
of
the
study
and
was
the
highest
residue
value
found.
The
study
indicated
an
approximately
linear
correlation
of
MCPDMU
vs
time
and
the
30
day
sample
was
the
longest
interval
provided.
2
%
CT
for
catfish.
Using
the
Q1*
for
monuron,
the
calculated
cancer
risk
to
the
U.
S.
general
population
from
potential
exposure
to
MCPDMU
in
catfish
alone
is
1.02
x
10
7
and
is
not
of
concern.
A
DWLOCcancer
for
MCPDMU
was
calculated
to
determine
whether
potential
exposures
to
MCPDMU
only
(
Drinking
Water
Assessment
for
diuron
and
its
degradates.
Ibrahim
Abdel
Saheb.
March
11,
2001)
in
drinking
water
from
surface
or
ground
water
sources
is
of
concern.
As
illustrated
below,
the
EEC
of
MCPDMU
from
surface
water
(
PRZM/
EXAMS)
exceeds
the
DWLOCcancer
and
is
of
concern.
Summary
of
Cancer
DWLOC
Calculations
for
MCPDMU
Population
Subgroup
Negligible
Risk
Q1*
(
mg/
kg/
d)
1
Chronic
Food
Exposure
PRZM/
EXAMS
(
ppb)
SCIGROW
(
ppb)
DWLOCcancer
(
ppb)
U.
S.
Population
0.000001
0.0152
0.000007
26
1.4
2.0
There
are
several
issues
to
consider
when
characterizing
the
magnitude
of
the
potential
cancer
risk
from
exposure
to
MCPDMU,
and
the
appropriateness
of
the
analogy
to
monuron
(
Personal
communication.
Alberto
Protzel.
October
4,
2001):
°
There
is
no
proven
mechanism
for
the
carcinogenic
effect
of
monuron
in
rats,
to
allow
for
the
satisfactory
evaluation
of
the
effect
on
carcinogenicity
of
going
from
the
4
chloro
isomer
in
monuron
to
the
3
chloro
isomer
in
the
water
metabolite.
°
There
are
no
toxicity
data
on
the
3
chloro
isomer
to
comfortably
rule
it
out
as
a
carcinogen.
In
the
absence
of
the
data
needed
for
a
more
comprehensive
evaluation,
the
carcinogenic
risk
assessment
was
conducted
using
the
Q1
*
of
monuron.
It
is
possible
to
speculate
that
the
actual
risk
for
49
the
3
chlorophenyl
isomer
might
be
lower
(
how
much
lower
cannot
be
established)
than
the
calculations
indicate
based
on
the
following
observations:
°
Both
monuron
and
its
metabolic
product
p
chloroaniline
(
a.
k.
a.
4
chloroaniline)
have
been
shown
to
be
carcinogens.
Monuron
produced
tumors
of
the
kidney
and
liver
in
male
rats
(
NTP
technical
Report
266,
1988).
PCA
produced
tumors
of
the
liver
and
spleen
in
male
mice
(
NTP
Technical
Report
351,
1989).
In
contrast,
the
pesticide
chlorpropham
(
isopropyl
m
chlorcarbanilate),
which
releases
3
chloroaniline
(
excreted
in
urine
as
1
2%
of
the
dose
and
is
a
moiety
associated
with
the
3
chloro
water
metabolite
of
diuron),
is
currently
classified
by
the
Agency
as
an
E
carcinogen.
Although
3
chloroaniline
produced
a
statistically
significant
increase
in
testicular
interstitial
cell
adenomas
in
rats,
well
above
historical
controls,
the
significant
increase
occurred
at
1000
mg/
kg/
day,
a
dose
considered
by
the
Agency
to
be
excessive.
°
Sabbioni
and
Neuman
(
Carcinogenesis
11:
111
115,1990)
studied
the
in
vivo
binding
of
arylamines
to
a
cellular
macromolecule
(
hemoglobin).
3
Chloroaniline
(
administered
to
rats
pure
or
as
chlorpropham)
produced
1/
10
or
less
the
amount
of
hemoglobin
adducts
that
was
produced
by
4
chloroaniline
(
administered
to
rats
pure
or
as
monuron).
This
observation
might
suggest
less
avidity
of
3
chloroaniline
than
4
chloroaniline
for
cellular
macromolecules.
6.0
CUMULATIVE
The
Agency
does
not
currently
have
data
available
to
determine
with
certainty
whether
diuron
has
a
common
mechanism
of
toxicity
with
any
other
substances.
For
purposes
of
this
human
health
risk
assessment,
the
Agency
has
assumed
that
diuron
does
not
have
a
common
mechanism
of
toxicity
with
any
other
pesticides.
Additional
weight
of
the
evidence
supports
this
approach
as
is
discussed
below.
In
May
1999,
the
Agency
performed
a
Section
18
risk
assessment
for
diuron
use
in
catfish
ponds
(
ID#
99MS0001.
SECTION
18
EXEMPTION
FOR
THE
USE
OF
DIURON
80W
IN
CATFISH
PONDS
IN
MISSISSIPPI.
DP
Barcode:
D255462.
Pamela
Hurley,
Richard
Loranger,
Steven
Weiss.
May
13,
1999).
At
that
time,
the
estimated
residues
of
propanil
and
linuron
were
added
to
those
of
diuron
and
the
risk
assessment
was
performed
using
the
noncancer
endpoints
selected
for
diuron.
All
three
chemicals
contain
within
their
structures,
3,4
DCA.
However,
linuron
and
diuron
are
ureas,
while
propanil
is
not.
Though
propanil
readily
metabolizes
to
3,4
DCA,
neither
diuron
nor
linuron
metabolize
to
3,4
DCA
in
plant
or
animal
metabolism
studies.
Since
1999,
the
Agency
has
received
and
evaluated
new
information,
performed
a
more
comprehensive
assessment
of
propanil
and
linuron,
and
re
evaluated
its
approach
to
the
assessment
of
diuron.
The
MARC
does
not
recommend
aggregating
residues
of
3,4
DCA
for
the
propanil
and
diuron
risk
assessments
[
Personal
communication.
Christine
Olinger
(
MARC
Chair)
to
Sherrie
Kinard.
September
19,
2001].
3,4
DCA
is
a
significant
residue
of
concern
for
propanil,
but
is
not
a
residue
of
50
concern
per
se
for
diuron.
The
analytical
method
for
quantifying
residues
of
concern
from
applications
of
diuron
converts
all
residues
to
3,4
DCA
as
a
technical
convenience.
However,
3,4
DCA
is
not
a
significant
residue
in
diuron
plant
and
animal
metabolism
or
hydrolysis
studies.
Therefore,
the
MARC
recommended
that
all
residues
hydrolyzable
to
3,4
DCA
would
be
included
in
the
tolerance
expression
for
diuron,
because
no
validated
enforcement
method
is
available
for
quantification
for
the
actual
residues
of
concern
for
diuron
[
Diuron.
Results
of
the
Health
Effects
Division
(
HED)
Metabolism
Assessment
Review
Committee
(
MARC)
Meeting
Held
on
03
JULY
2001.
John
Punzi.
August
10,
2001].
Additionally,
propanil
and
its
metabolite
3,4
DCA
were
found
to
induce
methemoglobinemia,
the
endpoint
of
concern
for
propanil.
Diuron
has
not
been
shown
to
cause
this
effect.
Diuron
induces
hemolytic
anemia
and
compensatory
hematopoiesis,
which
are
mechanistically
different
from
methemoglobinemia.
Linuron
and
diuron
metabolism
studies
show
that
both
chemicals
metabolize
to
DCPU
and
DCPMU.
However,
for
reasons
that
are
yet
unknown,
these
chemicals
do
not
induce
the
same
toxic
effects
in
mammals.
Submitted
data
indicate
that
diuron
is
primarily
(
though
not
exclusively)
metabolized
by
the
hydroxylation
of
the
urea
group
in
either
the
methyl
or
the
amino
position
and
conjugated.
Linuron,
on
the
other
hand,
appears
to
be
primarily
ring
hydroxylated
and
conjugated.
The
methoxy
group
is
removed,
followed
by
the
methyl
group,
with
ring
hydroxylation.
Unlike
linuron,
hydroxylation
of
the
phenyl
ring
is
not
a
major
metabolite
pathway
of
diuron
and,
both
methyl
groups
are
lost.
Methemoglobinemia
is
the
dominant
toxic
effect
of
concern
for
linuron.
As
mentioned
above,
diuron
does
not
induce
methemoglobinemia.
Mechanistic
and
reproductive
studies
show
that
linuron,
and
to
some
extent
propanil,
is
an
androgen
receptor
antagonist
and
that
linuron
induces
testicular
abnormalities
in
rodents.
Studies
with
diuron
showed
no
indications
of
any
endocrine
effects
and
no
developmental
or
reproductive
effects.
Though
the
mechanisms
of
action
for
the
differing
effects
induced
by
the
two
ureas,
diuron
and
linuron,
are
not
entirely
known,
there
is
sufficient
cause
to
believe
that
exposures
from
the
two
compounds
should
not
be
cumulated.
In
addition,
in
1999
the
estimated
dietary
cancer
risk
for
diuron
did
not
include
residues
from
linuron
and
propanil
since
it
was
recognized
that
the
target
organs
for
tumor
induction
for
diuron
are
different
from
those
for
linuron
and
propanil,
and
data
were
available
which
indicated
that
the
mechanism
of
action
may
be
different
for
diuron.
Currently
available
data
support
that
decision.
In
conclusion,
the
Agency
has
assumed
that
diuron
does
not
have
a
common
mechanism
of
toxicity
with
any
other
pesticides.
For
purposes
of
this
human
health
risk
assessment,
a
cumulative
risk
assessment
is
not
warranted.
7.0
OCCUPATIONAL
EXPOSURE
The
Agency
has
determined
that
there
are
potential
exposures
to
mixers,
loaders,
applicators
and
other
handlers
during
the
usual
use
patterns
associated
with
diuron.
Based
on
the
use
patterns,
31
51
major
occupational
exposure
scenarios
were
identified
for
diuron.
Calculations
of
noncancer
risk
based
on
inhalation
exposure
indicate
that
the
inhalation
margins
of
exposure
(
MOEs)
are
more
than
100
at
the
highest
possible
level
of
mitigation
for
all
of
the
short
term
occupational
exposure
scenarios
except
applying
sprays
with
a
high
pressure
handwand.
Sixteen
of
the
31
occupational
scenarios
were
identified
as
having
intermediate
term
durations
of
exposure.
Of
these,
none
have
a
non
cancer
risk
of
concern
for
intermediate
term
inhalation
exposure
at
the
highest
possible
level
of
mitigation.
A
noncancer
postapplication
risk
assessment
was
not
conducted,
since
no
systemic
toxicity
by
the
dermal
route
is
expected
for
the
short
or
intermediate
term
durations.
Postapplication
cancer
risks
for
private
growers
were
calculated
at
both
the
typical
application
rate
and
the
maximum
application
rate
for
each
crop
grouping.
All
cancer
risks
to
private
growers
were
less
than
1
x
10
4
on
the
day
of
treatment.
Postapplication
cancer
risks
for
commercial
applicators
were
calculated
at
the
typical
application
rate
for
each
crop
grouping.
All
potential
cancer
risks
to
commercial
applicators
were
less
than
1
x
10
4
on
the
day
of
treatment.
Occupational
risk
assessments
were
conducted
for
the
use
of
diuron
as
a
mildewcide
in
paint.
Four
occupational
handler
scenarios
were
identified
for
the
use
of
diuron
in
paint
and
are
expected
to
be
of
short
and
intermediate
term
exposure
duration.
The
calculations
of
short
and
intermediate
term
inhalation
risk
from
the
use
of
diuron
in
paint
indicate
that
MOEs
are
more
than
100
at
the
assessed
level
of
mitigation
for
all
the
exposure
scenarios,
except
applying
paints
with
an
airless
sprayer
(
indoors).
At
the
assessed
level
of
mitigation,
all
four
scenarios
have
potential
cancer
risks
between
1
x
10
4
and
1
x
10
6.
Occupational
postapplication
exposures
to
paint
containing
diuron
may
occur
in
industrial
settings
around
open
vats
used
in
paint
processing.
Inhalation
and
dermal
exposures
may
also
occur
while
maintaining
industrial
equipment.
No
postapplication
exposure
data
have
been
submitted
to
determine
the
extent
of
postapplication
exposures
in
the
industrial
settings.
Nonetheless,
inhalation
exposures
are
expected
to
be
minimal
because
of
the
low
vapor
pressure
of
diuron
(
2
x
10
7
mm
Hg
at
30
E
C)
and
aerosol
formation
is
not
expected.
Dermal
postapplication
exposures
are
expected
to
be
lower
than
when
handling/
loading
the
formulated
product.
Therefore,
postapplication
exposures
in
the
industrial
settings
are
expected
to
be
minimal
and
not
of
concern.
Occupational
risk
assessments
were
also
conducted
for
the
use
of
diuron
as
an
algaecide
in
commercial
fish
ponds.
Four
short
term
occupational
handler
scenarios
were
identified
for
the
use
of
diuron
in
commercial
fish
production
and
the
inhalation
MOEs
from
all
four
of
the
commercial
fish
production
scenarios
were
greater
than
100
at
the
baseline
level
of
mitigation
and
are
not
of
concern.
With
maximum
mitigation
measures
(
engineering
control
level),
all
four
scenarios
have
estimated
cancer
risks
of
less
than
1
x
10
6
and
are
not
of
concern.
Occupational
postapplication
exposure
to
diuron
in
treated
fish
production
ponds
is
not
likely
to
result
in
a
risk
of
concern
based
on
the
extremely
high
dilution
rate.
7.1
Agricultural
and
Non
crop/
Utility
Uses
7.1.1
Handler
52
The
EPA
has
determined
that
there
are
potential
exposures
to
mixers,
loaders,
applicators,
and
other
handlers
during
usual
use
patterns
associated
with
diuron.
Based
on
the
use
patterns,
31
major
occupational
exposure
scenarios
were
identified
for
diuron:
(
1a)
mixing/
loading
liquid
formulations
for
aerial
application;
(
1b)
mixing/
loading
liquid
formulations
for
chemigation;
(
1c)
mixing/
loading
liquid
formulations
for
groundboom
application;
(
1d)
mixing/
loading
liquid
formulations
for
rights
of
way
sprayers;
(
1e)
mixing/
loading
liquid
formulations
for
high
pressure
hand
wand;
(
2a)
mixing/
loading
dry
flowables
for
aerial
application;
(
2b)
mixing/
loading
dry
flowables
for
chemigation;
(
2c)
mixing/
loading
dry
flowables
for
groundboom
application;
(
2d)
mixing/
loading
dry
flowables
for
rights
of
way
spray
application;
(
2e)
mixing/
loading
dry
flowables
for
high
pressure
hand
wand;
(
3a)
mixing/
loading
wettable
powders
for
aerial
application;
(
3b)
mixing/
loading
wettable
powders
for
chemigation;
(
3c)
mixing/
loading
wettable
powders
for
groundboom
application;
(
3d)
mixing/
loading
wettable
powders
for
rights
of
way
spray
application;
(
3e)
mixing/
loading
wettable
powders
for
high
pressure
hand
wand;
(
4)
loading
granulars
for
tractor
drawn
spreaders;
(
5)
applying
sprays
for
aerial
application;
(
6)
applying
sprays
for
groundboom
application;
(
7)
applying
sprays
with
a
rights
of
way
sprayer;
(
8)
applying
sprays
with
a
high
pressure
hand
wand;
(
9)
applying
granulars
for
a
tractor
drawn
spreader;
(
10)
applying
granulars
with
a
spoon;
(
11)
applying
granulars
for
hand
application;
(
12)
flagging
aerial
spray
applications;
(
13)
mixing/
loading/
applying
liquids
with
a
low
pressure
hand
wand;
(
14)
mixing/
loading/
applying
liquids
with
a
backpack
sprayer;
(
15)
mixing/
loading/
applying
wettable
powders
with
a
low
pressure
hand
wand;
(
16)
loading/
applying
granulars
with
a
pump
feed
backpack
spreader;
(
17)
loading/
applying
gravity
feed
backpack
spreader;
(
18)
loading/
applying
granulars
for
a
belly
grinder
application;
and
(
19)
loading/
applying
granulars
with
a
push
type
spreader.
Since
granulars
are
only
used
on
non
crop/
utility
areas,
aerial
application
of
granulars
and
flaggers
supporting
aerial
operations
were
not
assessed.
Current
diuron
labels
have
PPE
requirements
ranging
from
no
PPE
listed
to
long
sleeved
shirt
and
long
pants,
waterproof
gloves,
shoes,
socks,
protective
eye
wear,
chemical
resistant
headgear,
and
a
dust/
mist
filtering
respirator.
Mixer
and
loaders
must
also
wear
a
chemical
resistant
apron.
Table
3
in
the
attached
document,
Occupational
and
Residential
Exposure
Assessment
and
Recommendations
for
the
Reregistration
Eligibility
Decision
Document
for
Diuron.
Renee
Sandvig
and
Christina
Jarvis.
October
16,
2001,
summarizes
the
caveats
and
parameters
specific
to
the
surrogate
data
used
for
each
handler
scenario
and
the
corresponding
exposure/
risk
assessment.
These
caveats
include
the
source
of
the
data
and
an
assessment
of
the
overall
quality
of
the
data.
The
assessment
of
data
quality
is
based
solely
on
the
number
of
observations
and
the
available
quality
control
data.
The
quality
control
data
are
based
on
a
grading
criteria
established
by
the
PHED
Task
Force.
The
PHED
Task
Force
is
comprised
of
representatives
from
the
U.
S.
EPA,
Health
Canada,
the
California
Department
of
Pesticide
regulation,
and
member
companies
of
the
American
Crop
Protection
Association.
The
sources
of
the
surrogate
include:
!
Pesticide
Handlers
Exposure
Database
(
PHED).
53
!
Outdoor
Residential
Exposure
Task
Force
(
ORETF).
The
task
force
recently
submitted
proprietary
data
to
the
Agency
on
hose
end
sprayers,
push
type
granular
spreaders,
and
handgun
sprayers
(
MRID
#
44972201).
The
ORETF
data
were
used
in
this
assessment
in
place
of
PHED
data
for
the
"
loading/
applying
granulars
using
a
push
type
spreader"
scenario.
!
Worker
Exposure
Study
During
Application
In
Banana
Plantation
With
Temik
10G
(
MRID
#
451672
01).
The
Agency
has
used
data
from
the
aldicarb
(
Temik)
study
to
assess
exposures
and
risks
to
handlers
applying
granulars
with
a
pump
feed
backpack
sprayer.
!
Worker
Exposure
Study
During
Application
of
Regent
20GR
In
Banana
Plantation
(
MRID
#
452507
02).
The
Agency
has
used
data
from
the
fipronil
(
Regent
20
GR)
study
to
assess
exposures
and
risks
to
handlers
loading
and
applying
granulars
with
a
gravity
feed
backpack
sprayer.
In
addition,
the
Agency
has
also
used
data
from
the
fipronil
study
to
assess
exposures
and
risks
to
occupational
handlers
loading
and
applying
granulars
using
a
scoop
and
bucket.
Calculations
for
the
handler
risk
assessment
were
completed
for
a
range
of
maximum
application
rates
for
specific
crops
recommended
by
the
available
diuron
labels
and
the
LUIS
report.
These
rates
were
assessed
in
order
to
bracket
risk
levels
associated
with
the
various
use
patterns.
7.1.1.1
Noncancer
Exposure
and
Risk
Estimates
Noncancer
handler
exposure
assessments
were
completed
using
a
baseline
exposure
scenario
and,
if
required,
increasing
levels
of
risk
mitigation
(
PPE
and
engineering
controls)
in
an
attempt
to
achieve
an
appropriate
margin
of
exposure.
The
baseline
scenario
generally
represents
a
handler
wearing
long
pants,
a
long
sleeved
shirt,
no
respirator,
and
no
chemical
resistant
gloves
(
there
are
exceptions
pertaining
to
the
use
of
gloves,
and
these
are
noted).
Noncancer
dermal
risks
from
the
use
of
diuron
were
not
calculated.
No
systemic
toxicity
following
repeated
dermal
dosing
at
1200
mg/
kg/
day
was
seen
in
the
rabbit
dermal
toxicity
study;
therefore,
a
quantitative
noncancer
dermal
risk
assessment
(
short
and
intermediate
term)
is
not
required.
However,
calculations
of
daily
dermal
exposure
and
daily
dermal
dose
were
included
for
purposes
of
the
cancer
risk
assessment.
Handler
exposures
to
diuron
are
expected
to
be
mainly
of
short
term
duration
(
one
day
to
one
month).
Intermediate
term
exposure
(
one
month
to
several
months)
for
handlers
is
possible
for
large
field
crops,
including
corn,
wheat,
oats
and
cotton,
because
of
their
long
planting
seasons.
Rights
ofway
sprayer
scenarios
for
utility
and
industrial
areas
are
assumed
to
be
of
intermediate
term
duration,
because
utility
workers
could
possibly
treat
rights
of
way
areas
(
roadsides,
railroads,
etc)
all
summer
long.
The
short
term
inhalation
MOEs
were
calculated
using
the
NOAEL
of
10
mg/
kg/
day,
from
the
developmental
toxicity
study
in
rabbits.
The
intermediate
term
MOEs
were
calculated
using
the
NOAEL
of
1.0
mg/
kg/
day,
from
the
chronic
toxicity
study
in
rats.
An
LOC
or
target
MOE
of
100
has
been
identified
as
the
target
risk
level
for
short
and
intermediate
term
occupational
exposure
scenarios.
Tables14
and
15
show
a
summary
of
the
short
and
intermediate
term
exposures
and
MOEs.
54
Of
the
31
identified
occupational
handler
exposure
scenarios,
all
short
and
intermediate
term
exposure
scenarios
resulted
in
MOEs
greater
than
100
with
PPE
and
Engineering
Control
mitigation
for
all
scenarios
for
which
engineering
controls
are
feasible.
The
only
scenario
for
which
the
estimated
risks
(
MOEs)
were
calculated
to
be
less
than
100,
and
therefore
of
concern
to
the
Agency,
is
Applying
Sprays
for
High
Pressure
Handwand
Application
at
the
maximum
application
rate
of
0.96
lb
ai
per
gallon,
at
both
minimum
and
maximum
levels
of
PPE
protection
(
MOEs
range
from
46
to
92).
Engineering
Controls
are
not
feasible
for
this
scenario.
7.1.1.2
Cancer
Exposure
and
Risk
Estimates
The
cancer
handler
exposure
scenarios
are
identical
to
those
assessed
in
the
noncancer
handler
assessment.
To
assess
cancer
risk,
a
total
daily
dose,
a
lifetime
daily
dose
and
a
total
cancer
risk
are
calculated.
The
total
daily
dose
is
calculated
to
include
both
dermal
and
inhalation
exposure
(
dermal
dose
includes
dermal
absorption
since
an
oral
cancer
endpoint
was
used)
and
used
a
Q1*=
1.91
x
10
2
(
mg/
kg/
day)
1
in
human
equivalents.
The
assessment
assumed
that
the
average
lifetime
is
70
years,
exposure
duration
is
35
years,
and
that
the
exposures
per
year
are:
10
days
per
year
for
the
private
grower
and
30
days
per
year
for
a
commercial
applicator.
Maximum
application
rates
were
used
in
the
private
grower
assessment.
Typical
application
rates
were
used
in
both
the
private
grower
and
commercial
applicator
assessments.
It
was
assumed
that
as
the
frequency
of
exposure
increased,
the
probability
of
being
exposed
to
a
maximum
application
rate
would
decrease.
Therefore,
maximum
application
rates
were
not
assessed
for
the
commercial
applicator.
Table
16
summarizes
the
cancer
risks
associated
with
the
handling
of
diuron
for
the
baseline,
maximum
PPE
and
engineering
control
level
of
mitigation.
In
general,
the
Agency
is
concerned
when
occupational
cancer
risk
estimates
exceed
1
x
10
4.
The
Agency
will
seek
ways
to
mitigate
the
risks,
to
the
extent
that
it
is
practical
and
economically
feasible,
to
lower
the
risks
to
1
x
10
6
or
less.
Five
of
the
assessed
scenarios
have
cancer
risks
greater
than
1
x
10
4
at
the
highest
feasible
level
of
mitigation
(
private
farmer/
commercial
applicator,
typical/
max
rate)
and
are
of
concern
(
See
Occupational
and
Residential
Exposure
Assessment
and
Recommendations
for
the
Reregistration
Eligibility
Decision
Document
for
Diuron.
Renee
Sandvig
and
Christina
Jarvis.
October
16,
2001).
Twenty
six
of
the
scenarios
have
cancer
risks
between
1
x
10
4
and
1
x
10
6
at
the
highest
feasible
level
of
mitigation
(
private
farmer/
commercial
applicator,
typical/
max
rate).
7.1.2
Postapplication
Exposures
EPA
has
determined
that
there
are
potential
postapplication
exposures
to
individuals
entering
treated
fields.
The
current
diuron
labels
have
a
restricted
entry
interval
(
REI)
requirement
of
12
hours
with
the
following
early
entry
PPE
required:
coveralls
over
long
sleeved
shirt
and
long
pants,
waterproof
gloves,
chemical
resistant
footwear
plus
socks,
protective
eye
wear
and
chemical
resistant
headgear
for
55
overhead
exposures.
Many
of
the
applications
of
diuron
are
soil
directed
or
pre
plant,
since
the
application
of
diuron
to
most
of
the
registered
crops
would
result
in
plant
damage.
Only
the
crops
whose
foliage
can
be
sprayed
without
damage
were
assessed
for
postapplication
exposure
to
foliage.
The
crops
that
can
be
sprayed
without
foliage
damage
are
oats,
wheat,
birdsfoot
treefoil,
clover,
grass
grown
for
seed,
alfalfa,
asparagus,
pineapple,
and
sugarcane.
Significant
exposure
to
diuron
may
result
from
contact
with
treated
soil
when
planting
seedlings,
moving
irrigation
lines,
or
other
soil
related
activities
since
diuron
is
applied
directly
to
the
soil.
At
this
time,
no
transfer
coefficients
exist
for
activities
resulting
in
contact
with
treated
soil.
There
are
also
no
data
on
the
soil
residue
dissipation
of
diuron.
A
worker
exposure
study
and
a
diuron
soil
residue
dissipation
study
would
be
needed
to
assess
this
risk.
Transfer
coefficients
do
not
exist
for
the
mechanical
harvesting
of
alfalfa
and
asparagus
and
these
activities
are
considered
of
special
concern
according
to
the
Agriculture
Transfer
Coefficient
Exposure
SAC
policy
3.1.
Significant
worker
exposure
is
possible
from
mechanical
harvesting
of
these
crops.
Since
diuron
can
be
applied
as
a
defoliant
soon
before
harvest,
exposure
to
cotton
harvesters
is
of
special
concern
for
this
chemical.
Data
recently
submitted
to
the
Agency
show
that
there
is
exposure
during
the
mechanical
harvesting
of
cotton.
Exposure
can
result
from
the
following
occupational
job
functions:
picker
operator,
module
builder,
tramper,
and
raker.
A
picker
operator
is
the
individual
that
drives
the
harvesting
machine,
usually
with
an
enclosed
cab.
A
module
builder
operator
is
the
individual
that
operates
the
controls
of
the
module
builder
into
which
the
picker
loads
the
cotton.
The
module
builder
is
used
to
receive
the
cotton
and
then
compact
it
into
modules
or
bales.
A
tramper
is
the
individual
who
stands
on
top
of
the
module
builder
and
helps
direct
the
cotton
out
of
the
picker
and
into
the
module
builder.
The
tramper
than
jumps
into
the
module
builder
and
redistributes
the
cotton
within
the
module
builder.
A
raker
is
the
individual
who
rakes
up
the
spilled
cotton
and
puts
it
back
into
the
module
builder.
The
models
presently
used
to
assess
occupational
postapplication
exposure
cannot
be
used
since
the
foliage
has
dropped
off
of
the
cotton
plants
by
the
time
of
harvest.
There
are
no
standard
default
transfer
coefficients
for
these
activities
at
this
time.
Data
on
these
exposure
potentials
are
requested.
Diuron
labels
with
the
cotton
defoliant
use
should
specify
that
cotton
can
only
be
harvested
mechanically.
Chemical
specific
postapplication
exposure
and/
or
environmental
fate
data
have
not
yet
been
submitted
by
the
registrant
in
support
of
reregistration
of
diuron.
In
lieu
of
these
data,
a
surrogate
postapplication
assessment
was
conducted
to
determine
potential
human
risks
incurred
from
applying
diuron
to
the
foliage
of
the
crops
that
can
be
sprayed
without
damage
to
the
leaves.
The
surrogate
assessment
in
Table
17
is
based
on
both
the
typical
and
maximum
application
rates
that
a
private
farmer/
grower
may
reasonably
be
expected
to
be
exposed
to
for
a
short
duration
(
10
days).
The
surrogate
assessment
in
Table
18
is
based
on
the
typical
application
rates
that
a
commercial
applicator
may
be
reasonably
expected
to
be
exposed
to
for
a
more
extended
duration
(
30
days).
The
maximum
56
application
rates
are
not
included
in
the
postapplication
assessment
for
the
commercial
applicator,
as
it
is
unlikely
that
a
commercial
applicator
would
be
exposed
at
the
maximum
application
rate
for
30
days
a
year,
i.
e.
it
was
assumed
that
as
the
frequency
of
the
exposure
increased,
the
probability
of
being
exposed
to
a
maximum
application
rate
would
decrease.
7.1.2.1
Noncancer
Postapplication
Exposure
and
Risk
Estimates
A
noncancer
postapplication
risk
assessment
was
not
conducted,
since
no
systemic
toxicity
by
the
dermal
route
is
expected
for
the
short
or
intermediate
term
durations.
57
7.1.2.2
Postapplication
Exposure
and
Risk
Estimates
for
Cancer
In
general,
the
Agency
is
concerned
when
postapplication
occupational
cancer
risk
estimates
exceed
1
x10
4.
This
diuron
postapplication
cancer
assessment
assumes
that
a
worker
would
contact
day
zero
residues
(
residues
on
the
day
of
application)
for
ten
or
thirty
days
a
year,
every
year
for
35
years.
Since
it
is
unlikely
that
a
postapplication
worker
would
contact
the
highest
possible
residue
value
for
that
length
of
time,
this
assessment
is
considered
very
conservative.
7.1.2.2.1
Private
Growers
(
10
Days
Exposure
Per
Year)
Postapplication
cancer
risks
for
private
growers
were
calculated
at
both
the
typical
application
rate
and
the
maximum
application
rate
for
each
crop
grouping.
All
cancer
risks
to
private
growers
were
less
than
1
x
10
4
on
the
day
of
treatment
(
Table
17).
7.1.2.2.2
Commercial
Farm
Workers
(
30
Days
Exposure
Per
Year)
Postapplication
cancer
risks
for
commercial
farm
workers
were
calculated
at
the
typical
application
rate
for
each
crop
grouping.
All
potential
cancer
risks
to
commercial
farm
workers
were
less
than
1
x
10
4
on
the
day
of
treatment
(
Table
18).
Historically,
setting
REIs
on
cancer
endpoints
has
been
difficult
because
of
the
need
for
lifetime
use
assumptions.
To
estimate
the
LADD
(
Life
time
Average
Daily
Dose),
the
typical
application
rate,
the
number
of
days
worked
per
year,
and
the
number
of
years
one
would
be
exposed
during
a
working
lifetime
are
needed.
Each
one
of
these
variables
is
dependent
upon
many
factors.
For
example,
the
number
of
days
worked
per
year
must
correspond
to
the
days
worked
when
the
pesticide
of
concern
has
been
applied.
Additionally,
the
residue
dissipation
over
the
work
interval
should
be
estimated.
Without
an
estimate
for
residue
dissipation
one
needs
to
assume
(
conservatively)
that
the
worker
travels
from
one
treated
field
to
another
so
that
the
highest
residue
value
is
always
contacted.
In
the
case
of
diuron,
a
screening
estimate
was
developed
because
lifetime
use
data
are
not
available.
7.2
Mildewcide
in
Paints,
Solvents,
Adhesives,
and
Coatings
7.2.1
Occupational
Handler
Exposures/
Risks
Diuron
is
used
as
a
mildewcide
in
paints,
solvents,
adhesives,
stains,
polymer
latices,
plaster,
stuccos,
sealants,
caulking,
fillers,
and
coatings.
For
these
uses,
four
labels
exist:
EPA
Reg.
Nos.
67071
15,
67071
2,
67071
17,
and
5383
101.
These
products
are
formulated
as
a
flowable
concentrate,
a
tablet,
an
emulsifiable
concentrate,
and
a
paste
form,
respectively.
Traditionally,
OPP's
Antimicrobial
Division
assesses
antimicrobial
uses
of
pesticides.
However,
in
the
case
of
diuron,
the
antimicrobial
uses
were
assessed
by
HED.
These
pesticide
products
are
incorporated
into
paint
at
0.20
to
2.5
%
during
the
initial
phase
of
the
manufacturing
process.
HED
has
identified
and
assessed
the
58
primary
handlers
as
those
individuals
who
mix
and
load
diuron
formulation
at
the
manufacturing
facility
for
use
as
a
mildewcide
in
adhesives,
caulks,
sealants,
and
paints
(
see
discussion
of
primary
vs.
secondary
handlers
in
section
4.4.1
Home
Uses).
The
secondary
handlers
are
commercial
applicators
who
apply
adhesives,
caulks,
sealants,
and
paints.
No
handler
exposure
data
have
been
submitted
to
determine
the
extent
of
these
exposures.
The
Agency
assessed
the
risks
to
the
primary
handlers
using
the
dermal
and
inhalation
exposure
data
for
loading
liquids
and
tablet
formulations
from
the
proprietary
Chemical
Manufacturers
Association
(
CMA)
antimicrobial
exposure
study
(
MRID
42587501).
No
unit
exposure
data
exist
to
assess
the
mixing
and
loading
of
the
paste
formulation
into
paint.
It
is
assumed
that
this
exposure
would
be
similar
to
mixing
and
loading
liquids
into
paint
products.
Two
primary
handler
exposure
scenarios
have
been
identified
and
include:
1)
Mixing/
Loading
liquids
and
2)
Loading
tablets.
In
addition
to
the
primary
handlers,
secondary
handlers
are
assessed
using
an
airless
sprayer
and
a
paint
brush.
Unit
exposure
data
used
to
assess
the
exposure
resulting
from
applying
paint
containing
diuron
with
an
airless
sprayer
and
a
paintbrush
were
taken
from
a
previous
chlorothalonil
assessment
(
again,
see
discussion
in
section
4.4.1
Home
Uses).
The
clothing
and
PPE
scenarios
for
each
type
of
exposure
reflect
the
clothing
and
PPE
worn
in
the
study
from
which
the
unit
exposure
values
were
derived.
Although
there
is
potential
exposure
during
the
application
of
the
other
treated
materials
(
e.
g.,
caulks
and
sealants),
they
are
not
included
because
no
data
are
available
to
assess
the
uses.
There
is
also
potential
for
exposure
from
applying
paint
with
a
roller.
It
is
HED's
professional
judgement
that
the
airless
sprayer
and
paintbrush
scenarios
represent
the
high
end
exposures
for
diuron
antimicrobial
secondary
uses.
Two
secondary
handler
exposure
scenarios
have
been
identified
and
include:
3)
Applying
paints
with
an
airless
sprayer,
and
4)
Applying
paints
with
a
paint
brush.
These
four
exposure
scenarios
were
used
to
assess
the
handler
risks
to
diuron's
antimicrobial
uses.
The
noncancer
and
cancer
risk
equations
and
assumptions
stated
previously
in
this
assessment
were
also
used
to
calculate
exposure
from
diuron's
antimicrobial
uses.
The
industrial
and
commercial
painter
exposure
scenarios
are
believed
to
have
a
short
(
one
to
30
days)
and
intermediate
term
(
one
month
to
180
days)
exposure
duration.
It
is
assumed
that
diuron
would
only
be
mixed
into
paint
every
other
week,
five
days
a
week.
This
type
of
intermittent
exposure
frequency
is
not
considered
a
chronic
exposure
scenario
(
greater
then
180
days)
because
diuron
is
not
believed
to
be
used
continuously
for
at
least
180
days
and
the
rat
metabolism
study
(
MRID
440196
01)
indicates
that
urinary
and
fecal
excretion
of
diuron
is
nearly
complete
within
24
hours
in
the
low
dose
groups
(
10
mg/
kg/
day)
and
within
48
hours
in
high
dose
groups
(
400
mg/
kg/
day).
For
the
cancer
risk
assessment,
workers
handling
diuron
in
the
industrial
setting
(
mixing
diuron
into
paints)
are
assumed
to
be
exposed
to
diuron
in
paints
125
days
per
year
(
50
weeks
worked/
year
x
0.5
"
every
other
week"
x
5
days/
week)
and
commercial
painters
applying
diuron
treated
paint
are
assumed
to
be
exposed
50
days
per
year
(
only
in
paints
needing
mildewcide
and
not
all
paint
is
treated
with
diuron).
59
7.2.1.1
Noncancer
Risks
The
short
term
inhalation
NOAEL
of
10
mg/
kg/
day
and
the
intermediate
term
inhalation
NOAEL
of
1.0
mg/
kg/
day
were
used
for
all
noncancer
exposures
and
have
a
target
MOE
of
100.
The
calculations
of
short
term
inhalation
risk
indicate
that
inhalation
MOEs
are
more
than
100
at
the
assessed
level
of
mitigation
for
the
all
the
exposure
scenarios
and
therefore,
not
of
concern.
The
calculations
of
intermediate
term
inhalation
risk
indicate
that
inhalation
MOEs
are
more
than
100
at
the
assessed
level
of
mitigation
for
the
all
the
exposure
scenarios
except
the
following
(
Table
19):
!
Applying
paints
with
an
airless
sprayer
indoors.
7.2.1.1
Cancer
Risks
In
general,
the
Agency
is
concerned
when
occupational
cancer
risk
estimates
exceed
1
x
10
4.
The
Agency
will
seek
ways
to
mitigate
the
risks,
to
the
extent
that
it
is
practical
and
economically
feasible,
to
lower
the
risks
to
1
x
10
6
or
less.
The
following
scenarios
have
cancer
risks
between
1
x
10
4
and
1
x
10
6
at
the
assessed
level
of
mitigation
(
Table
20):
!
(
1)
Mixing/
loading
of
liquids
into
paint
products;
!
(
2)
Loading
of
tablets
into
paint
products;
!
(
3)
Applying
paints
with
an
airless
sprayer;
and
!
(
4)
Applying
paints
with
a
paint
brush.
All
scenarios
were
assessed
at
the
maximum
rate
of
application.
Average
application
rate
for
the
paint
use
is
unknown
and
is
requested
to
refine
this
risk.
7.2.2
Postapplication
Exposures
to
Paint
Containing
Diuron
Postapplication
exposures
may
occur
in
industrial
settings
around
open
vats
used
in
paint
processing.
Inhalation
and
dermal
exposures
may
also
occur
while
maintaining
industrial
equipment.
No
postapplication
exposure
data
have
been
submitted
to
determine
the
extent
of
postapplication
exposures
in
the
industrial
settings.
Nonetheless,
inhalation
exposures
are
expected
to
be
minimal
because
of
the
low
vapor
pressure
of
diuron
(
2
x
10
7
mmHg
at
30
E
C)
and
aerosol
formation
is
not
expected.
Dermal
postapplication
exposures
are
expected
to
be
lower
than
when
handling/
loading
the
formulated
product.
Therefore,
postapplication
exposures
in
the
industrial
settings
are
expected
to
be
minimal
and
not
of
concern.
60
7.3
Algaecide
in
Commercial
Fish
Production
7.3.1
Handlers
Diuron
is
also
used
as
an
algaecide
in
the
commercial
production
of
ornamental
fish,
bait
fish,
and
catfish.
For
these
uses,
there
are
two
state
labels
(
FL99000200
and
AR99000800),
a
section
18,
and
several
other
Griffin
labels
pending
approval.
Based
on
the
use
patterns
of
diuron
as
an
algaecide,
four
occupational
exposure
scenarios
were
identified:
(
1a)
Mixing/
loading
dry
flowables
for
catfish
production;
(
1b)
Mixing/
loading
dry
flowables
for
ornamental
fish
production;
(
2a)
Mixing/
loading
wettable
powders
for
catfish
production;
and
(
2b)
Mixing/
loading
wettable
powders
for
ornamental
fish
production.
All
handler
exposures
are
expected
to
be
short
term
in
duration.
An
occupational
assessment
on
the
use
of
diuron
in
commercial
catfish
production
has
already
been
conducted
by
the
Agency
(
ID
#
99MS0001.
Section
18
Exemption
for
the
Use
of
Diuron
80W
in
Catfish
Ponds
in
Mississippi.
Pam
Hurley,
Rick
Loranger,
and
Steven
Weiss.
May
13,
1999).
All
assumptions
used
to
calculate
exposure
are
based
on
this
assessment.
Since
no
other
data
exist
at
this
time,
the
assumptions
used
for
catfish
production
in
this
assessment
are
assumed
to
be
applicable
to
ornamental
fish
production
as
well.
The
noncancer
and
cancer
risk
equations
and
assumptions
stated
previously
in
this
assessment
were
also
used
to
calculate
exposure
from
commercial
fish
production.
HED
assumed
an
average
pond
size
of
15
acres,
4
feet
deep,
with
20
ponds
per
farm
(
no
more
than
25%
would
be
expected
to
be
treated
per
day).
The
assumptions
on
pond
size
and
numbers
of
ponds
per
farm
are
based
on
telephone
conversations
between
HED
staff
(
Pilot
Interdisciplinary
Risk
Assessment
Team)
and
contacts
at
Auburn
and
Mississippi
State
Universities
in
1996.
7.3.1.1
Noncancer
Exposures/
Risks
for
Pond
Uses
The
LOC
or
target
MOE
for
short
term
inhalation
exposures
is
100.
The
inhalation
MOEs
from
all
four
of
the
commercial
fish
production
scenarios
were
greater
than
100
at
the
baseline
level,
without
mitigation,
and
are
not
considered
a
risk
of
concern
(
Table
21).
7.3.1.2
Cancer
Exposures/
Risks
In
general,
the
Agency
is
concerned
when
occupational
cancer
risk
estimates
exceed
1
x
10
4.
The
Agency
will
seek
ways
to
mitigate
the
risks,
to
the
extent
that
it
is
practical
and
economically
feasible,
to
lower
the
risks
to
1
x
10
6
or
less.
All
four
exposure
scenarios
have
cancer
risks
between
1
x
10
4
and
1
x
10
6
at
the
baseline
level
of
mitigation.
When
additional
PPE
was
added
as
a
mitigation
measure,
exposures
from
mixing/
loading
dry
flowables
for
catfish
ponds
and
mixing/
loading
wettable
powders
resulted
in
potential
cancer
risks
of
less
than
1
x
10
6
and
not
of
concern.
When
additional
PPE
was
added
to
the
mixing/
loading
dry
flowables
for
ornamental
fish
ponds
scenario,
the
potential
cancer
risk
was
calculated
to
be
between
1
x
10
4
and
1
x
10
6.
All
four
exposure
scenarios
have
cancer
risks
of
less
than
1
x
10
6
with
maximum
feasible
mitigation,
including
engineering
controls
(
Table
22).
61
7.3.2
Occupational
Postapplication
Exposures
to
Commercial
Fish
Ponds
Occupational
postapplication
exposure
to
diuron
in
treated
fish
production
ponds
is
not
likely
to
result
in
a
risk
of
concern
based
on
the
extremely
high
dilution
rate
(
maximum
application
rate
is
0.00000838
lb
ai/
gallon
of
pond
water),
low
frequency
of
postapplication
activities,
and
a
low
dermal
absorption
value
(
4%).
7.4
Incident
Data
The
Agency
searched
several
databases
for
reports
of
incidents
occurring
resulting
from
exposures
to
diuron.
The
databases
searched
were
the
Incident
Data
System
(
IDS),
American
Association
of
Poison
Control
Centers
(
AAPCC),
California
Pesticide
Illness
Surveillance
Program,
and
National
Pesticide
Telecommunication
Network
(
NPTN).
There
were
incidents
reported
involving
both
adults
and
children.
Most
were
treated
on
an
outpatient
basis
but
a
few
required
hospitalization
and
one
death
occurred.
A
direct
connection
between
exposure
to
diuron
as
the
cause
and
the
reported
death
has
not
been
made
as
of
this
writing.
Some
incident
reports
described
symptoms
such
as
eye
irritation,
rash,
dizziness,
respiratory
irritation
and
headaches
for
both
agricultural
and
nonagricultural
exposures.
Specific
details
may
be
found
in
Review
of
Diuron
Poisoning
Incident
Data.
Chemical:
#
035505.
Ruth
Allen.
October
11,
2001.
The
incident
data
show
that
the
number
of
poisoning
incidents
for
diuron
alone
is
relatively
small
in
any
one
surveillance
system.
Also,
the
incidents
are
scattered
in
time
and
location,
and
many
of
the
incidents
involve
diuron
use
in
mixtures.
Therefore,
few
conclusions
can
be
drawn.
However,
the
1995
Louisiana
elementary
school
incident
in
which
diuron
was
associated
with
the
illnesses
of
23
children
and
9
adults,
remains
unexplained.
There
are
no
known
recreational
or
school
building
registered
uses
of
diuron.
The
Agency
has
an
independent
initiative
to
reduce
the
use
of
pesticides
in
and
around
schools.
If
diuron
is
associated
with
other
illnesses
in
schools,
consideration
should
be
given
to
label
language
modifications
that
would
specifically
prohibit
use
in
and
around
schools.
8.0
DATA
NEEDS/
LABEL
REQUIREMENTS
Product
Chemistry
1.
The
product
chemistry
data
base
is
not
complete;
new
confidential
statements
of
formula
(
CSFs)
are
required
which
reflect
preliminary
analyses
of
current
products
together
with
discussions
of
formation
of
impurities.
2.
UV/
Visible
absorption
data/
spectra
are
required
(
830.7050).
Residue
Chemistry
62
Refer
to
Table
B
on
page
52
of
the
Residue
Chemistry
Chapter
for
the
Diuron
Reregistration
Eligibility
Decision
(
RED)
Document.
John
Punzi.
July
29,
2001
for
more
details
of
the
requirements,
listed
by
guideline.
3.
Label
revisions
are
required
for
many
crops
in
order
to
reflect
the
parameters
of
use
patterns
for
which
residue
data
are
available.
Many
of
the
revisions
concern
retreatment
intervals,
Preharvest
Intervals
(
PHI's)
and
rotational
crop
restrictions.
4.
Though
adequate
analytical
methods
exist
for
data
collection
and
tolerance
enforcement
in
plants,
independent
laboratory
validation
of
the
enforcement
method
is
required
for
livestock
methods
prior
to
Agency
validation.
5.
Multiresidue
methods
for
diuron
and
metabolites
of
toxic
concern
are
required
for
plants
and
livestock.
6.
Results
from
animal
feeding
studies
suggest
that
tolerances
are
necessary
for
poultry
or
egg
commodities
and
for
meats
and
milk.
Residue
data
are
not
available
for
several
potential
feed
items.
If
the
maximum
dietary
burden
does
not
increase
when
recalculated
from
all
potential
feed
items
after
acceptable
field
trial
data
are
submitted,
then
the
established
tolerances
for
residues
in
fat,
meat,
and
meat
byproducts
of
cattle,
goats,
hogs,
horses,
and
sheep
can
be
lowered.
7.
The
reregistration
requirements
for
magnitude
of
the
residue
in
plants
are
not
fulfilled
for:
alfalfa
forage;
globe
artichoke;
barley
hay;
cotton
gin
byproducts;
field
corn
aspirated
grain
fractions;
field
corn
forage
and
stover;
filbert;
grass
forage,
hay,
seed
screenings,
and
straw;
lemon;
pear;
oat
forage,
hay;
olive;
field
pea
vines
and
hay;
sorghum
aspirated
grain
fractions,
stover,
and
forage;
wheat
forage
and
hay.
Additional
crop
field
trial
data
are
required
for
these
commodities.
8.
The
reregistration
requirements
for
processing
data
are
not
fulfilled
for:
field
corn
and
olives.
9.
The
registrants
have
indicated
that
a
Section
3
tolerance
for
diuron
in/
on
catfish
is
desired.
Since
the
metabolism
committee
is
concerned
with
a
monochlorinated
diuron
metabolite
identified
in
water,
a
metabolism
study
of
diuron
in
fish
is
required.
The
registrants
are
directed
to
OPPTS
860.1400
for
study
guidelines
and
encouraged
to
submit
a
study
protocol
prior
to
initiating
the
study.
10.
Field
rotational
crop
trials
have
been
conducted
on
representative
crops
at
less
that
the
maximum
application
rates,
and
with
1
year
plant
back
intervals
(
PBI).
Some
labels
indicate
a
2
year
PBI.
The
Agency
recommends
that
the
registrants
provide
additional
data
to
support
the
higher
application
rate
and
believes
that
the
2
yr
PBI
is
not
practical.
The
registrants
should
remove
the
2
63
yr
PBI
from
the
registered
uses
and
provide
data
to
support
the
3.2
lb
ai/
A
application
rate
and
1
yr
PBI.
Until
adequate
data
are
supplied,
labels
should
be
amended
to
restrict
rotational
crops
to
those
crops
which
currently
are
registered
as
primary
crops.
Toxicology
11.
A
28
day
inhalation
study
is
required
to
address
the
concern
for
inhalation
exposure
potential
based
on
the
use
pattern.
The
registrant
can
follow
the
90
day
inhalation
study
protocol
but
cease
exposure
at
28
days.
Occupational/
Residential
Exposures
12.
Data
are
needed
to
assess
the
following
occupational
handler
scenarios:
mixing/
loading/
applying
wettable
powders
or
dry
flowables
with
a
backpack
sprayer,
and
mixing/
loading/
applying
dry
flowables
with
a
low
pressure
handwand.
13.
Average
application
rate
for
the
paint
use
is
unknown
and
is
requested
to
refine
the
cancer
risk
from
paint
use.
14.
No
transfer
coefficients
exist
for
activities
resulting
in
contact
with
treated
soil.
There
are
also
no
data
on
the
soil
residue
dissipation
of
diuron.
A
worker
exposure
study
and
a
diuron
soil
residue
dissipation
study
would
be
needed
to
assess
the
risk
from
postapplication
contact
with
treated
soil.
15.
Transfer
coefficients
do
not
exist
for
the
mechanical
harvesting
of
alfalfa
and
asparagus
and
these
activities
are
considered
of
special
concern
according
to
the
Agriculture
Transfer
Coefficient
Exposure
SAC
policy
3.1.
ATTACHMENTS
Carcinogenicity
Peer
Review
of
Diuron.
Linda
Taylor
and
Esther
Rinde.
May
8,
1997.
Diuron
(
PC
035505):
Assessment
of
Mode
of
Action
on
Bladder
Carcinogenicity.
Yung
Yang.
September
20,
2001.
DIURON:
Cancer
Classification
and
Mechanism
of
Action.
Yung
Yang.
October
10,
2001.
Diuron
Chronic
Dietary
Exposure
Assessment
(
PC
Code
035505);
DP
Barcode
D276683;
Case
0046.
John
Punzi.
September
10,
2001.
Diuron.
List
A
Reregistration
Case
0046.
PC
Code
035505.
Product
Chemistry
Chapter
for
the
64
Reregistration
Eligibility
Decision
[
RED]
Document.
DP
Barcode
D274489.
Ken
Dockter.
June
26,
2001.
Diuron
Metabolism
Committee
Briefing
Memo.
John
Punzi.
August
27,
2001.
DIURON
Report
of
the
FQPA
Safety
Factor
Committee.
Brenda
Tarplee.
August
7,
2001.
DIURON:
2nd
Report
of
the
Hazard
Identification
Assessment
Review
Committee.
Yung
Yang.
August
28,
2001.
Diuron.
Results
of
the
Health
Effects
Division
(
HED)
Metabolism
Assessment
Review
Committee
(
MARC)
Meeting
Held
on
03
JULY
2001.
John
Punzi.
August
10,
2001.
Diuron
Revised
Q1*,
(
3/
4'
s
Interspecies
Scaling
Factor),
1985
Wistar
Rat
2
Year
Dietary
Study.
PC
035505.
Bernice
Fisher.
September
23,
1998.
Diuron
Toxicology
Disciplinary
Chapter
for
the
Reregistration
Eligibility
Decision.
Yung
Yang.
0ctober
2,
2001.
Drinking
Water
Assessment
for
Diuron
and
its
Degradates.
Ibrahim
Abdel
Saheb.
March
11,
2001.
MONURON:
Quantitative
Risk
Assessment
(
Q1
*)
Based
On
F344/
N
Rat
Dietary
Study
With
3/
4'
s
Interspecies
Scaling
Factor.
PC
Code
035501.
Lori
L.
Brunsman.
July
5,
2001.
Occupational
and
Residential
Exposure
Assessment
and
Recommendations
for
the
Reregistration
Eligibility
Decision
Document
for
Diuron.
Renee
Sandvig
and
Christina
Jarvis.
December
5,
2001.
Quantitative
Usage
Analysis
for
Diuron.
Alan
Halvorson.
March
20,
2001.
Residue
Chemistry
Chapter
for
the
Diuron
Reregistration
Eligibility
Decision
Document.
John
Punzi.
July
29,
2001.
Review
of
Diuron
Poisoning
Incident
Data.
Chemical:
#
035505.
Ruth
Allen.
October
11,
2001.
Updated
QUA.
Alan
Halvorson.
April
27,
2001.
65
Table
14:
Summary
of
Short
Term
Exposure
Variables
and
MOEs
for
Agricultural
and
Non
crop
Uses
Exposure
Scenario
(
Scenario
#)
Cropa
Application
ratesb
Area
Treatedc
Inhalation
Baseline
MOEd,
e
Inhalation
Min
PPE
MOEd,
f
Inhalation
Max
PPE
MOEd,
g
Short
term
Inhalation
Eng.
Control
MOEd,
h
Mixer/
Loader
Mixing/
Loading
Liquids
for
Aerial
application
(
1a)
Sugarcane
6
lb
ai
per
acre
350
Acres
per
day
280
Alfalfa
3.2
lb
ai
per
acre
1200
Acres
per
day
150
Mixing/
Loading
Liquids
for
Chemigation
application
(
1b)
Sugarcane
6
lb
ai
per
acre
350
Acres
per
day
280
Mixing/
Loading
Liquids
for
Groundboom
application
(
1c)
Grapes
9.6
lb
ai
per
acre
80
Acres
per
day
760
Alfalfa
3.2
lb
ai
per
acre
200
Acres
per
day
910
Mixing/
Loading
Liquids
for
Rights
of
Way
Sprayer
application
(
1d)
Grapes
0.19
lb
ai
per
gallon
1000
Gallons
per
day
3,000
Utility/
industrial
areas
0.90
lb
ai
per
gallon
650
Mixing/
Loading
Liquids
for
High
Pressure
Handwand
application
(
1e)
Grapes
0.19
lb
ai
per
gallon
1000
Gallons
per
day
3,000
Utility/
industrial
areas
0.90
lb
ai
per
gallon
650
Mixing/
Loading
Dry
Flowables
for
Aerial
application
(
2a)
Sugarcane
6.4
lb
ai
per
acre
350
Acres
per
day
410
Alfalfa
3.2
lb
ai
per
acre
1200
Acres
per
day
240
Mixing/
Loading
Dry
Flowables
for
Chemigation
application
(
2b)
Sugarcane
6.4
lb
ai
per
acre
350
Acres
per
day
410
Mixing/
Loading
Dry
Flowables
for
Groundboom
application
(
2c)
Grapes
9.6
lb
ai
per
acre
80
Acres
per
day
1,200
Exposure
Scenario
(
Scenario
#)
Cropa
Application
ratesb
Area
Treatedc
Inhalation
Baseline
MOEd,
e
Inhalation
Min
PPE
MOEd,
f
Inhalation
Max
PPE
MOEd,
g
Short
term
Inhalation
Eng.
Control
MOEd,
h
66
Alfalfa
3.2
lb
ai
per
acre
1200
Acres
per
day
1,400
Mixing/
Loading
Dry
Flowables
for
Rights
of
Way
Sprayer
application
(
2d)
Grapes
0.19
lb
ai
per
gallon
1000
Gallons
per
day
4,700
Utility/
Industrial
Areas
0.96
lb
ai
per
gallon
950
Mixing/
Loading
Dry
Flowables
for
High
Pressure
handwand
application
(
2e)
Grapes
0.19
lb
ai
per
gallon
1000
Gallons
per
day
4,700
Utility/
Industrial
Areas
0.96
lb
ai
per
gallon
950
Mixing/
Loading
Wettable
Powders
for
Aerial
application
(
3a)
Sugarcane
6.4
lb
ai
per
acre
350
Acres
per
day
7.3
36
73
1,300
Alfalfa
3.2
lb
ai
per
acre
1200
Acres
per
day
4.2
21
42
760
Mixing/
Loading
Wettable
Powders
for
Chemigation
application
(
3b)
Sugarcane
6.4
lb
ai
per
acre
350
Acres
per
day
7.3
36
73
1,300
Mixing/
Loading
Wettable
Powders
for
Groundboom
application
(
3c)
Grapes
9.6
lb
ai
per
acre
80
Acres
per
day
21
110
Alfalfa
3.2
lb
ai
per
acre
200
Acres
per
day
25
130
Mixing/
Loading
Wettable
Powders
for
Rights
of
Way
Sprayer
application
(
3d)
Grapes
0.19
lb
ai
per
gallon
1000
Gallons
per
day
85
420
Utility/
Industrial
Areas
0.96
lb
ai
per
gallon
17
85
170
Mixing/
Loading
Wettable
Powders
for
High
Pressure
handwand
application
(
3e)
Grapes
0.19
lb
ai
per
gallon
1000
Gallons
per
day
85
420
Exposure
Scenario
(
Scenario
#)
Cropa
Application
ratesb
Area
Treatedc
Inhalation
Baseline
MOEd,
e
Inhalation
Min
PPE
MOEd,
f
Inhalation
Max
PPE
MOEd,
g
Short
term
Inhalation
Eng.
Control
MOEd,
h
67
Utility/
Industrial
Areas
0.96
lb
ai
per
gallon
17
85
170
Loading
Granulars
for
Tractor
Drawn
Spreaders
application
(
4)
Utility/
Industrial
Areas
87.1
lb
ai
per
acre
80
Acres
per
day
59
300
Applicator
Applying
Sprays
for
Aerial
application
(
5)
Sugarcane
6.4
lb
ai
per
acre
350
Acres
per
day
see
eng.
controls
see
eng.
controls
see
eng.
controls
4,600
Alfalfa
3.2
lb
ai
per
acre
1200
Acres
per
day
see
eng.
controls
see
eng.
controls
see
eng.
controls
2,700
Applying
Sprays
for
Groundboom
application
(
6)
Grapes
9.6
lb
ai
per
acre
80
Acres
per
day
1200
Alfalfa
3.2
lb
ai
per
acre
200
Acres
per
day
1500
Applying
Sprays
for
Rightsof
Way
Sprayer
application
(
7)
Grapes
0.19
lb
ai
per
gallon
1000
Gallons
per
day
930
NF
Utility/
Industrial
Areas
0.96
lb
ai
per
gallon
190
NF
Applying
Sprays
for
High
Pressure
handwand
application
(
8)
Grapes
0.19
lb
ai
per
gallon
1000
Gallons
per
day
46
230
NF
Utility/
Industrial
Areas
0.96
lb
ai
per
gallon
9.2
46
92
NF
Applying
Granulars
for
Tractor
Drawn
Spreaders
application
(
9)
Utility/
Industrial
Areas
87.1
lb
ai
per
acre
80
Acres
per
day
84
420
460
Applying
Granulars
with
a
spoon
(
10)
Industrial
Areas
87.1
lb
ai
per
acre
100
sq
ft
per
day
78,000
NF
Applying
Granulars
for
Hand
application
(
11)
Industrial
Areas
87.1
lb
ai
per
acre
100
sq
ft
per
day
740
NF
Flagger
Exposure
Scenario
(
Scenario
#)
Cropa
Application
ratesb
Area
Treatedc
Inhalation
Baseline
MOEd,
e
Inhalation
Min
PPE
MOEd,
f
Inhalation
Max
PPE
MOEd,
g
Short
term
Inhalation
Eng.
Control
MOEd,
h
68
Flagging
for
Sprays
application
(
12)
Sugarcane
6.4
lb
ai
per
acre
350
Acres
per
day
890
Mixer/
Loader/
Applicator
Mixing/
Loading/
Applying
Liquids
for
Low
Pressure
Handwand
application
(
13)
Industrial
Areas
0.90
lb
ai
per
gallon
40
Gallons
per
day
650
NF
Mixing/
Loading/
Applying
Liquids
for
Backpack
sprayer
application
(
14)
Industrial
Areas
0.90
lb
ai
per
gallon
40
Gallons
per
day
650
NF
Mixing/
Loading/
Applying
Wettable
Powders
for
Low
Pressure
Handwand
application
(
15)
Industrial
Areas
0.96
lb
ai
per
gallon
40
Gallons
per
day
17
83
170
NF
Loading/
Applying
Granulars
with
a
pump
feed
granular
spreader
(
16)
Industrial
Areas
87.1
lb
ai
per
acre
5
Acres
per
day
380
NF
Loading/
Applying
Granulars
with
a
gravity
feed
granular
spreader
(
17)
Industrial
Areas
87.1
lb
ai
per
acre
5
Acres
per
day
36
180
NF
Loading/
Applying
Granulars
for
Belly
Grinder
application
(
18)
Industrial
Areas
87.1
lb
ai
per
acre
1
Acre
per
day
130
NF
Loading/
Applying
Granulars
for
Push
type
spreader
(
ORETF)
application
(
19)
Industrial
Areas
87.1
lb
ai
per
acre
5
Acres
per
day
210
NF
Footnotes:
a
Crops
named
are
index
crops
which
are
chosen
to
represent
all
other
crops
at
or
near
that
application
rate
for
that
use.
See
the
application
rates
listing
in
the
use
summary
section
of
this
document
for
further
information
on
application
rates
used
in
this
assessment.
b
Application
Rates
are
based
on
the
maximum
application
rates
listed
on
the
diuron
labels.
c
Amount
handled
per
day
are
from
Science
Advisory
Council
on
Exposure's
Policy
#
9.1.9
d
Short
term
MOE
=
Short
term
NOAEL
(
mg/
kg/
day)/
Daily
Inhalation
Dose
(
mg/
kg/
day).
e
Baseline:
no
respirator.
f
Minimum
PPE:
dust
mist
respirator.
g
Maximum
PPE:
organic
vapor
respirator.
h
Engineering
controls:
closed
mixing/
loading,
enclosed
cab,
truck
or
cockpit.
See
the
appendix,
Tables
A,
B,
C
and
D
for
the
inputs
and
dermal
and
inhalation
dose
calculations.
69
Scenario's
calculated
MOE
exceeds
the
target
MOE
at
the
previous
level
of
mitigation.
(
MOE
>
100),
NF
=
Not
feasible
for
this
scenario
(
no
available
engineering
controls).
Bolded
MOE
values
show
a
risk
of
concern
at
the
highest
possible
level
of
mitigation
for
the
corresponding
scenario.
70
Table
15:
Summary
of
Intermediate
Term
Exposure
Variables
and
MOEs
for
Agricultural
and
Non
crop
Uses
Exposure
Scenario
(
Scenario
#)
Cropa
Application
ratesb
Area
Treatedc
Inhalation
Baseline
MOEd,
e
Inhalation
Min
PPE
MOEd,
f
Inhalation
Max
PPE
MOEd,
g
Inhalation
Eng.
Control
MOEd,
h
Mixer/
Loader
Mixing/
Loading
Liquids
for
Aerial
application
(
1a)
cotton
2.2
lb
ai
per
acre
350
Acres
per
day
76
380
1200
Acres
per
day
22
110
Mixing/
Loading
Liquids
for
Chemigation
application
(
1b)
cotton
2.2
lb
ai
per
acre
350
Acres
per
day
76
380
Mixing/
Loading
Liquids
for
Groundboom
application
(
1c)
cotton
2.2
lb
ai
per
acre
80
Acres
per
day
330
200
Acres
per
day
130
Mixing/
Loading
Liquids
for
Rights
Of
Way
Sprayer
(
1d)
utility/
industrial
areas
0.9
lb
ai
per
gallon
1000
gallons
per
day
65
320
Mixing/
Loading
Dry
Flowables
for
Aerial
application
(
2a)
cotton
2.2
lb
ai
per
acre
350
Acres
per
day
120
1200
Acres
per
day
34
180
Mixing/
Loading
Dry
Flowables
for
Chemigation
application
(
2b)
cotton
2.2
lb
ai
per
acre
350
Acres
per
day
120
Mixing/
Loading
Dry
Flowables
for
Groundboom
application
(
2c)
cotton
2.2
lb
ai
per
acre
80
Acres
per
day
520
1200
Acres
per
day
210
Mixing/
Loading
Dry
Flowables
for
Rights
Of
Way
Sprayer
(
2d)
utility/
industrial
areas
0.96
lb
ai
per
gallon
1000
gallons
per
day
95
490
Mixing/
Loading
Wettable
Powders
for
Aerial
application
(
3a)
cotton
2.2
lb
ai
per
acre
350
Acres
per
day
2.1
11
21
380
1200
Acres
per
day
0.62
3.1
6.2
110
Mixing/
Loading
Wettable
Powders
for
Chemigation
application
(
3b)
cotton
2.2
lb
ai
per
acre
350
Acres
per
day
2.1
11
21
380
Exposure
Scenario
(
Scenario
#)
Cropa
Application
ratesb
Area
Treatedc
Inhalation
Baseline
MOEd,
e
Inhalation
Min
PPE
MOEd,
f
Inhalation
Max
PPE
MOEd,
g
Inhalation
Eng.
Control
MOEd,
h
71
Mixing/
Loading
Wettable
Powders
for
Groundboom
application
(
3c)
cotton
2.2
lb
ai
per
acre
80
Acres
per
day
9.2
46
92
1,700
200
Acres
per
day
3.7
18
37
660
Mixing/
Loading
Wettable
Powders
for
Rights
Of
Way
Sprayer
(
3d)
utility/
industrial
areas
0.96
lb
ai
per
gallon
1000
gallons
per
day
1.7
8.5
17
300
Applicator
Applying
Sprays
for
Aerial
application
(
5)
cotton
2.2
lb
ai
per
acre
350
Acres
per
day
see
eng.
controls
see
eng.
controls
see
eng.
controls
1,300
1200
Acres
per
day
see
eng.
controls
see
eng.
controls
see
eng.
controls
390
Applying
Sprays
for
Groundboom
application
(
6)
cotton
2.2
lb
ai
per
acre
80
Acres
per
day
540
200
Acres
per
day
210
Applying
Sprays
for
Rights
Of
Way
(
7)
utility/
industrial
areas
0.96
lb
ai
per
gallon
1000
gallons
per
day
19
93
190
Flagger
Flagging
for
Sprays
application
(
12)
cotton
2.2
lb
ai
per
acre
350
Acres
per
Day
260
Footnotes:
a
Crops
named
are
index
crops
which
are
chosen
to
represent
all
other
crops
at
or
near
that
application
rate
for
that
use.
See
the
application
rates
listing
in
the
use
summary
section
of
this
document
for
further
information
on
application
rates
used
in
this
assessment.
b
Application
Rates
are
based
on
the
maximum
application
rates
listed
on
the
diuron
labels.
c
Amount
handled
per
day
are
from
Science
Advisory
Council
on
Exposure's
Policy
#
9.1.9
d
Short
term
MOE
=
Short
term
NOAEL
(
mg/
kg/
day)/
Daily
Inhalation
Dose
(
mg/
kg/
day).
e
Baseline:
no
respirator.
f
Minimum
PPE:
dust
mist
respirator.
g
Maximum
PPE:
organic
vapor
respirator.
h
Engineering
controls:
Closed
mixing/
loading,
enclosed
cab,
truck
or
cockpit.
See
the
appendix,
Tables
E,
F,
G,
and
H
for
the
inputs
and
dermal
and
inhalation
dose
calculations.
Scenario's
calculated
MOE
exceeds
the
target
MOE
at
the
previous
level
of
mitigation.
(
MOE
>
100),
NF
=
Not
feasible
for
this
scenario
(
no
available
engineering
controls).
Bolded
MOE
values
show
a
risk
of
concern
at
the
highest
possible
level
of
mitigation
for
the
corresponding
scenario.
72
Table
16:
Cancer(
Q*)
Risk
Summary
for
Agricultural
and
Non
crop
Uses
Exposure
Scenario
(
Scenario
#)
Baselinea
Maximum
PPEb
Engineering
Controlc
Private
Farmer/
10
days/
Maximu
m
Rate
Cancer
Riskd
Private
Farmer/
10
days/
Typical
Rate
Cancer
Riske
Commercial
applicator/
30
days/
Typical
Rate
Cancer
Riskf
Private
Farmer/
10
days/
Maximu
m
Rate
Cancer
Riskd
Private
Farmer/
10
days/
Typica
l
Rate
Cancer
Riske
Commercial
applicator/
30
days/
Typical
Rate
Cancer
Riskf
Private
Farmer/
10
days/
Maximu
m
Rate
Cancer
Riskd
Private
Farmer/
10
days/
Typical
Rate
Cancer
Riske
Commercial
applicator/
30
days/
Typical
Rate
Cancer
Riskf
Mixer/
Loader
Mixing/
Loading
Liquids
for
Aerial
application
(
1a)
9.2
E
4
6.1
E
4
1.8
E
3
6.3
E
6
4.2
E
6
1.3
E
5
3.4
E
6
2.2
E
6
6.7
E
6
1.7
E
3
1.3
E
3
3.9
E
3
1.2
E
5
9.0
E
6
2.7
E
5
6.1
E
6
4.8
E
6
1.4
E
5
Mixing/
Loading
Liquids
for
Chemigation
application
(
1b)
9.2
E
4
6.1
E
4
1.8
E
3
6.3
E
6
4.2
E
6
1.3
E
5
3.4
E
6
2.2
E
6
6.7
E
6
Mixing/
Loading
Liquids
for
Groundboom
application
(
1c)
3.4
E
4
1.4
E
4
4.2
E
4
2.3
E
6
9.6
E
7
2.9
E
6
1.2
E
6
5.1
E
7
1.5
E
6
2.8
E
4
2.2
E
4
6.6
E
4
1.9
E
6
1.5
E
6
4.5
E
6
1.0
E
6
8.0
E
7
2.4
E
6
Mixing/
Loading
Liquids
for
Rights
of
Way
Sprayer
application
(
1d)
8.4
E
5
2.8
E
5
8.4
E
5
5.7
E
7
1.9
E
7
5.7
E
7
3.1
E
7
1.0
E
7
3.1
E
7
3.9
E
4
3.9
E
4
1.2
E
3
2.7
E
6
2.7
E
6
8.1
E
6
1.4
E
6
1.4
E
6
4.3
E
6
Mixing/
Loading
Liquids
for
High
Pressure
handwand
application
(
1e)
8.4
E
5
2.8
E
5
8.4
E
5
5.7
E
7
1.9
E
7
5.7
E
7
3.1
E
7
1.0
E
7
3.1
E
7
3.9
E
4
3.9
E
4
1.2
E
3
2.7
E
6
2.7
E
6
8.1
E
6
1.4
E
6
1.4
E
6
4.3
E
6
Mixing/
Loading
Dry
Flowables
for
Aerial
application
(
2a)
2.9
E
5
1.8
E
5
5.4
E
5
1.6
E
5
1.0
E
5
3.1
E
5
5.6
E
7
3.5
E
7
1.1
E
6
4.9
E
5
3.8
E
5
1.2
E
4
2.8
E
5
2.2
E
5
6.6
E
5
9.6
E
7
7.5
E
7
2.3
E
6
Mixing/
Loading
Dry
Flowables
for
Chemigation
application
(
2b)
2.9
E
5
1.8
E
5
5.4
E
5
1.6
E
5
1.0
E
5
3.1
E
5
5.6
E
7
3.5
E
7
1.1
E
6
Mixing/
Loading
Dry
Flowables
for
Groundboom
application
(
2c)
9.8
E
6
4.1
E
6
1.2
E
5
5.6
E
6
2.3
E
6
7.0
E
6
1.3
E
7
8.0
E
8
2.4
E
7
8.2
E
6
6.4
E
6
1.9
E
5
4.7
E
6
3.7
E
6
1.1
E
5
1.9
E
7
1.3
E
7
3.8
E
7
Exposure
Scenario
(
Scenario
#)
Baselinea
Maximum
PPEb
Engineering
Controlc
Private
Farmer/
10
days/
Maximu
m
Rate
Cancer
Riskd
Private
Farmer/
10
days/
Typical
Rate
Cancer
Riske
Commercial
applicator/
30
days/
Typical
Rate
Cancer
Riskf
Private
Farmer/
10
days/
Maximu
m
Rate
Cancer
Riskd
Private
Farmer/
10
days/
Typica
l
Rate
Cancer
Riske
Commercial
applicator/
30
days/
Typical
Rate
Cancer
Riskf
Private
Farmer/
10
days/
Maximu
m
Rate
Cancer
Riskd
Private
Farmer/
10
days/
Typical
Rate
Cancer
Riske
Commercial
applicator/
30
days/
Typical
Rate
Cancer
Riskf
73
Mixing/
Loading
Dry
Flowables
for
Rights
of
Way
Sprayer
application
(
2d)
2.5
E
6
8.2
E
7
2.5
E
6
1.4
E
6
4.7
E
7
1.4
E
6
4.8
E
8
1.6
E
8
4.8
E
8
1.2
E
5
1.2
E
5
3.7
E
5
7.0
E
6
7.0
E
6
2.1
E
5
2.4
E
7
2.4
E
7
7.2
E
7
Mixing/
Loading
Dry
Flowables
for
High
Pressure
handwand
application
(
2e)
2.5
E
6
8.2
E
7
2.5
E
6
1.4
E
6
4.7
E
7
1.4
E
6
4.8
E
8
1.6
E
8
4.8
E
8
1.2
E
5
1.2
E
5
3.7
E
5
7.0
E
6
7.0
E
6
2.1
E
5
2.4
E
7
2.4
E
7
7.2
E
7
Mixing/
Loading
Wettable
Powders
for
Aerial
application
(
3a)
1.6
E
3
10.0
E
4
3.0
E
3
8.0
E
5
5.0
E
5
1.5
E
4
5.3
E
6
3.3
E
6
9.9
E
6
2.7
E
3
2.1
E
3
6.4
E
3
1.4
E
4
1.1
E
4
3.2
E
4
9.1
E
6
7.1
E
6
2.1
E
5
Mixing/
Loading
Wettable
Powders
for
Chemigation
application
(
3b)
1.6
E
3
10.0
E
4
3.0
E
3
8.0
E
5
5.0
E
5
1.5
E
4
5.3
E
6
3.3
E
6
9.9
E
6
Mixing/
Loading
Wettable
Powders
for
Groundboom
application
(
3c)
5.5
E
4
2.3
E
4
6.9
E
4
2.7
E
5
1.1
E
5
3.4
E
5
1.8
E
6
7.6
E
7
2.3
E
6
4.6
E
4
3.6
E
4
1.1
E
3
2.3
E
5
1.8
E
5
5.3
E
5
1.5
E
6
1.2
E
6
3.5
E
6
Mixing/
Loading
Wettable
Powders
for
Rights
of
Way
Sprayer
application
(
3d)
1.4
E
4
4.6
E
5
1.4
E
4
6.8
E
6
2.3
E
6
6.8
E
6
4.5
E
7
1.5
E
7
4.5
E
7
6.9
E
4
6.9
E
4
2.1
E
3
3.4
E
5
3.4
E
5
1.0
E
4
2.3
E
6
2.3
E
6
6.8
E
6
Mixing/
Loading
Wettable
Powders
for
High
Pressure
handwand
application
(
3e)
1.4
E
4
4.6
E
5
1.4
E
4
6.8
E
6
2.3
E
6
6.8
E
6
4.5
E
7
1.5
E
7
4.5
E
7
6.9
E
4
6.9
E
4
2.1
E
3
3.4
E
5
3.4
E
5
1.0
E
4
2.3
E
6
2.3
E
6
6.8
E
6
Loading
Granulars
for
Tractor
Drawn
Spreaders
application
(
4)
5.3
E
5
5.3
E
5
1.6
E
4
8.0
E
6
8.0
E
6
2.4
E
5
1.1
E
6
1.1
E
6
3.2
E
6
Applicator
Exposure
Scenario
(
Scenario
#)
Baselinea
Maximum
PPEb
Engineering
Controlc
Private
Farmer/
10
days/
Maximu
m
Rate
Cancer
Riskd
Private
Farmer/
10
days/
Typical
Rate
Cancer
Riske
Commercial
applicator/
30
days/
Typical
Rate
Cancer
Riskf
Private
Farmer/
10
days/
Maximu
m
Rate
Cancer
Riskd
Private
Farmer/
10
days/
Typica
l
Rate
Cancer
Riske
Commercial
applicator/
30
days/
Typical
Rate
Cancer
Riskf
Private
Farmer/
10
days/
Maximu
m
Rate
Cancer
Riskd
Private
Farmer/
10
days/
Typical
Rate
Cancer
Riske
Commercial
applicator/
30
days/
Typical
Rate
Cancer
Riskf
74
Applying
Sprays
for
Aerial
application
(
5)
See
eng
controls
See
eng
controls
See
eng
controls
See
eng
controls
See
eng
controls
See
eng
controls
2.2
E
6
1.4
E
6
4.2
E
6
See
eng
controls
See
eng
controls
See
eng
controls
See
eng
controls
See
eng
controls
See
eng
controls
3.9
E
6
3.0
E
6
9.0
E
6
Applying
Sprays
for
Groundboom
application
(
6)
3.7
E
6
1.6
E
6
4.7
E
6
1.5
E
6
6.2
E
7
1.8
E
6
7.0
E
7
2.9
E
7
8.7
E
7
3.1
E
6
2.4
E
6
7.3
E
6
1.2
E
6
9.6
E
7
2.9
E
6
5.8
E
7
4.5
E
7
1.4
E
6
Applying
Sprays
for
Rights
of
Way
Sprayer
application
(
7)
4.0
E
5
1.3
E
5
4.0
E
5
8.6
E
6
2.9
E
6
8.6
E
6
NF
NF
NF
2.0
E
4
2.0
E
4
6.0
E
4
4.3
E
5
4.3
E
5
1.3
E
4
NF
NF
NF
Applying
Sprays
for
High
Pressure
handwand
application
(
8)
1.1
E
4
3.6
E
5
1.1
E
4
1.6
E
5
5.3
E
6
1.6
E
5
NF
NF
NF
5.2
E
4
5.4
E
4
1.6
E
3
8.0
E
5
8.0
E
5
2.4
E
4
NF
NF
NF
Applying
Granulars
for
Tractor
Drawn
Spreaders
application
(
9)
4.2
E
5
4.2
E
5
1.3
E
4
7.5
E
6
7.5
E
6
2.3
E
5
7.9
E
6
7.9
E
6
2.4
E
5
Applying
Granulars
with
a
Spoon
(
10)
9.3
E
8
9.3
E
8
2.8
E
7
6.6
E
8
6.6
E
8
2.0
E
7
NF
NF
NF
Applying
Granulars
for
Hand
application
(
11)
2.5
E
5
2.5
E
5
7.4
E
5
1.2
E
5
1.2
E
5
3.7
E
5
NF
NF
NF
Flagger
Flagging
for
Spray
application
(
12)
6.6
E
6
4.1
E
6
1.2
E
5
3.6
E
6
2.3
E
6
6.8
E
6
1.3
E
7
8.3
E
8
2.5
E
7
Mixer/
Loader/
App
Mixing/
Loading/
Applyin
g
Liquids
for
Low
Pressure
Handwand
application
(
13)
5.4
E
4
5.4
E
4
1.6
E
3
2.4
E
6
2.4
E
6
7.2
E
6
NF
NF
NF
Exposure
Scenario
(
Scenario
#)
Baselinea
Maximum
PPEb
Engineering
Controlc
Private
Farmer/
10
days/
Maximu
m
Rate
Cancer
Riskd
Private
Farmer/
10
days/
Typical
Rate
Cancer
Riske
Commercial
applicator/
30
days/
Typical
Rate
Cancer
Riskf
Private
Farmer/
10
days/
Maximu
m
Rate
Cancer
Riskd
Private
Farmer/
10
days/
Typica
l
Rate
Cancer
Riske
Commercial
applicator/
30
days/
Typical
Rate
Cancer
Riskf
Private
Farmer/
10
days/
Maximu
m
Rate
Cancer
Riskd
Private
Farmer/
10
days/
Typical
Rate
Cancer
Riske
Commercial
applicator/
30
days/
Typical
Rate
Cancer
Riskf
75
Mixing/
Loading/
Applyin
g
Liquids
for
Backpack
sprayer
application
(
14)
1.8
E
5
1.8
E
5
5.3
E
5
9.0
E
6
9.0
E
6
2.7
E
5
NF
NF
NF
Mixing/
Loading/
Applyin
g
Wettable
Powders
for
Low
Pressure
Handwand
application
(
15)
2.1
E
4
2.1
E
4
6.2
E
4
5.1
E
5
5.1
E
5
1.5
E
4
NF
NF
NF
Loading/
Applying
Granulars
with
a
Pump
Feed
Backpack
Spreader
(
16)
1.4
E
5
1.4
E
5
4.0
E
5
7.8
E
6
7.8
E
6
2.4
E
5
Loading/
Applying
Granulars
with
a
Gravity
Feed
Backpack
Spreader
(
17)
1.1
E
4
1.1
E
4
3.3
E
4
5.4
E
5
5.4
E
5
1.6
E
4
Loading/
Applying
Granulars
for
Belly
Grinder
application
(
18)
1.5
E
4
1.5
E
4
4.5
E
4
7.6
E
5
7.6
E
5
3.1
E
4
NF
NF
NF
Loading/
Applying
Granulars
for
Push
type
spreader
(
ORETF)
application
(
19)
3.5
E
5
3.5
E
5
1.1
E
4
5.5
E
6
5.5
E
6
1.7
E
5
NF
NF
NF
Footnotes:
a
Baseline
represents
long
pants,
long
sleeved
shirt,
no
gloves
(
except
scenarios
10,
11,
14,
15,
16
and
17
which
represent
gloves),
open
mixing/
loading,
open
cab/
tractor,
and
no
respirator.
b
Maximum
PPE
represents
long
sleeves,
long
pants,
coveralls,
chemical
resistant
gloves,
open
mixing/
loading,
open
cab
tractor
and
an
organic
vapor
respirator,
except
for
scenarios
10,
16
and
17,
which
represent
single
layer
of
clothing,
gloves
and
a
dust
mist
respirator
(
minimum
PPE)
which
is
the
clothing
scenarios
from
the
proprietary
studies
(
EPA
MRIDs
451672
01
and
452507
02).
c
Engineering
controls:
closed
mixing/
loading,
enclosed
cab,
truck
or
cockpit.
Baseline
level
clothing.
Chemical
resistant
gloves
for
the
mixing/
loading
of
liquids.
d
Cancer
risk
assessed
using
the
maximum
label
application
rates
and
10
days
of
exposure
per
year
assumed
for
a
private
farmer.
e
Cancer
risk
assessed
using
the
typical
application
rates
given
to
EPA
by
Griffin,
sources
quoted
are
Doanes,
NCFAP,
USDA,
and
Griffin
Information.
Maximum
application
rates
were
used
for
the
non
crop/
industrial
areas,
because
no
information
of
the
typical
rates
of
these
uses
is
available.
10
days
of
exposure
per
year
assumed
for
a
private
farmer.
f
Cancer
risk
assessed
using
the
typical
application
rates
given
to
EPA
by
Griffin,
sources
quoted
are
Doanes,
NCFAP,
USDA,
and
Griffin
Information.
Maximum
application
rates
were
used
for
the
non
crop/
industrial
areas,
because
no
information
of
the
typical
rates
of
these
uses
is
available.
30
days
of
exposure
per
year
assumed
for
a
commercial
applicator.
Cancer
risk
=
LADD
(
mg/
kg/
day)
*
Q1
(
1.91
E
2
mg/
kg/
day1).
See
appendix
Tables
I
,
J
,
and
K
for
the
inputs
and
calculations
of
total
daily
dose,
LADD
and
cancer
risk.
NF
=
Not
feasible
for
this
scenario
(
no
available
engineering
controls).
76
Bolded
cancer
risks
values
have
risks
less
than
1.0
E
4
at
the
highest
possible
level
of
mitigation.
77
Table
17:
Cancer
Postapplication
for
Private
Growers
(
Shorter
Term
Duration/
10
Days
Exposure
Per
Year)
Transfer
Coefficient
Crop
Groupinga
Diuron
Specific
Crops
b
Highest
Crop
Group
Application
Rate
(
lbs
ai/
acre)
c
Transfer
Coefficient
d
(
cm2/
hr)
Activitye
DATf
DFRg
(
F
g/
cm2)
LADDh
Cancer
Riski
Field/
row
crops,
low/
medium
Oats,
Wheat,
Birdsfoot
Trefoil,
Clover,
Grass
Grown
For
Seed,
and
Alfalfa.
2.5
(
typical)
100
(
low)
Irrigation,
scouting,
thinning
0
5.61
3.5e
5
6.7e
7
1500
(
medium)
Irrigation,
scouting
0
5.61
5.3e
4
1.0e
5
3.25
(
maximum)
100
(
low)
Irrigation,
scouting,
thinning
0
7.29
4.6e
5
8.7e
7
1500
(
medium)
Irrigation,
scouting
0
7.29
6.8e
4
1.3e
5
Sugarcane
Sugarcane
2.4
(
typical)
1000
(
medium)
Scouting
immature
plants
0
5.39
3.4e
4
6.4e
6
6.4
(
maximum)
1000
(
medium)
Scouting
immature
plants
0
14.36
9.0e
4
1.7e
5
Vegetable,
Stem./
Stalk
Asparagus
and
Pineapple.
4
(
typical)
300
(
low)
Irrigation,
scouting,
thinning
0
8.98
1.7e
4
3.2e
6
500
(
medium)
Irrigation
and
scouting
mature
plants
0
8.98
2.8e
4
5.4e
6
1000
(
high)
hand
harvesting
and
pruning
0
8.98
5.6e
4
1.1e
5
6.4
(
maximum)
300
(
low)
Irrigation,
scouting,
thinning
0
14.36
2.7e
4
5.2e
6
500
(
medium)
Irrigation
and
scouting
mature
plants
0
14.36
4.5e
4
8.6e
6
1000
(
high)
hand
harvesting
and
pruning
0
14.36
9.0e
4
1.7e
5
Footnotes:
a
Crops
were
grouped
according
to
the
transfer
coefficient
crop
groups
listed
in
Science
Advisory
Council
on
Exposure
Policy
3.1.14
b
Crops
within
the
transfer
coefficient
group
that
are
registered
for
diuron.
c
Highest
application
rate
for
all
of
the
diuron
specific
crops
within
the
transfer
coefficient
crop
group.
d
Transfer
Coefficients
from
Science
Advisory
Council
on
Exposure
Policy
3.1.14
e
Activities
from
Science
Advisory
Council
on
Exposure
Policy
3.1.14
Every
activity
listed
may
not
occur
for
every
crop
in
the
group.
f
DAT
is
"
days
after
treatment"
(
0
days
=
12
hours
after
application).
g
DFR
(
F
g/
cm2)
=
application
rate
*
correction
factor
*
fraction
of
ai
retained
on
foliage
(
20%)
*
(
1
dissipation
rate
(
10%))
time(
hours).
78
h
Lifetime
average
daily
dose
(
LADD)
(
mg/
kg/
day)
=
Average
Daily
Dose
(
mg/
kg/
day)
*
(
10
days
of
exposure
per
year
/
365
days/
year)
*
(
35
years
exposed
/
70
years
in
a
lifetime).
i
Cancer
risk
=
LADD
(
mg/
kg/
day)
*
Q1
(
1.91
E
2
mg/
kg/
day1).
79
Table
18:
Cancer
Postapplication
for
Commercial
Farm
Workers
(
Longer
Term
Duration/
30
Days
Exposure
Per
Year)
Transfer
Coefficient
Crop
Groupinga
Diuron
Specific
Crops
b
Highest
Crop
Group
Application
Rate
(
lbs
ai/
acre)
c
Transfer
Coefficient
d
(
cm2/
hr)
Activitye
DATf
DFRg
(
F
g/
cm2)
LADDh
Cancer
Riski
Field/
row
crops,
low/
medium
Oats,
Wheat,
Birdsfoot
Trefoil,
Clover,
Grass
Grown
For
Seed,
and
Alfalfa.
2.5
(
typical)
100
(
low)
Irrigation,
scouting,
thinning,
weeding
immature/
low
foliage
plants
0
5.61
1.1e
4
2.0e
6
1500
(
medium)
Irrigation,
scouting,
weeding
mature/
high
foliage
plants
0
5.61
1.6e
3
3.0e
5
Sugarcane
Sugarcane
2.4
(
typical)
1000
(
medium)
Scouting
immature
plants
0
5.39
1.0e
3
1.9e
5
Vegetable,
Stem./
Stalk
Asparagus
and
Pineapple.
4
(
typical)
300
(
low)
Irrigation,
scouting,
thinning,
weeding
immature
plants
0
8.98
5.1e
4
9.7e
6
500
(
medium)
Irrigation
and
scouting
mature
plants
0
8.98
8.4e
4
1.6e
5
1000
(
high)
hand
harvesting
and
pruning
0
8.98
1.7e
3
3.2e
5
Footnotes:
a
Crops
were
grouped
according
to
the
transfer
coefficient
crop
groups
listed
in
Science
Advisory
Council
on
Exposure
Policy
3.1.14.
b
Crops
within
the
transfer
coefficient
group
that
are
registered
for
diuron.
c
Highest
application
rate
for
all
of
the
diuron
specific
crops
within
the
transfer
coefficient
crop
group.
d
Transfer
Coefficients
from
Science
Advisory
Council
on
Exposure
Policy
3.1.14
e
Activities
from
Science
Advisory
Council
on
Exposure
Policy
3.1.14
Every
activity
listed
may
not
occur
for
every
crop
in
the
group.
f
DAT
is
"
days
after
treatment"
(
0
days
=
12
hours
after
application).
g
DFR
(
F
g/
cm2)
=
application
rate
*
correction
factor
*
fraction
of
ai
retained
on
foliage
(
20%)
*
(
1
dissipation
rate
(
10%))
time(
hours).
h
Lifetime
average
daily
dose
(
LADD)
(
mg/
kg/
day)
=
Average
Daily
Dose
(
mg/
kg/
day)
*
(
30
days
of
exposure
per
year
/
365
days/
year)
*
(
35
years
exposed
/
70
years
in
a
lifetime).
i
Cancer
risk
=
LADD
(
mg/
kg/
day)
*
Q1
(
1.91
E
2
mg/
kg/
day1).
80
Table
19:
Short
and
Intermediate
term
Antimicrobial
Uses
of
Diuron
and
MOEs
Exposure
Scenario
(
Scenario
#)
Clothing
Attire
Dermal
Unit
Exposure
(
mg/
lb
ai)
a
Inhalation
Unit
Exposure
(
F
g/
lb
ai)
b
Max
Appl.
Ratec
(
lb
ai/
gal)
Amount
Treatedd
Dermal
Dose
(
mg/
kg/
day)
e
Inhalation
Dose
(
mg/
kg/
day)
f
Short
term
Inhalation
MOEg
Int.
term
Inhalation
MOEg
Primary
Handlers
Mixing/
loading
of
Liquids
into
Paint
Products
(
1)
Open
pour,
long
pants,
long
sleeved
shirt,
chemical
resistant
gloves,
and
a
5
fold
PF
dust/
mist
type
respirator
0.184
1.7
0.0532
100
gal
0.014
0.00013
77,000
7,700
1,000
gal
0.14
0.0013
7,700
770
Loading
of
Tablets
into
Paint
Products
(
2)
0.412
11.8
0.0532
100
gallons
0.031
0.00090
11,000
1,100
1,000
gal
0.31
0.0090
1,100
110
Secondary
Handlers
Applying
Paints
with
an
Airless
Sprayer
(
3)
Indoor
Long
pants,
long
sleeved
shirt,
and
a
5
fold
PF
dust/
mist
type
respirator
36.22
470
0.0532
50
gallons
1.4
0.018
560
56
Long
pants,
long
sleeved
shirt,
gloves,
and
a
5
fold
PF
dust/
mist
type
respirator
12
470
0.46
0.018
560
56
Outdoor
Long
pants,
long
sleeved
shirt,
and
a
5
fold
PF
dust/
mist
type
respirator
33.33
86.6
0.0532
50
gallons
1.3
0.0033
3,000
300
Long
pants,
long
sleeved
shirt,
gloves,
and
a
5
fold
PF
dust/
mist
type
respirator
8.87
86.6
0.34
0.0033
3,000
300
Applying
Paints
with
a
Paint
Brush
(
4)
Long
pants,
long
sleeved
shirt,
and
a
5
fold
PF
dust/
mist
type
respirator
290
101
0.0532
5
gallons
1.1
0.00038
26,000
2,600
Footnotes:
a,
b
Dermal
and
inhalation
unit
exposures
are
from
CMA
and
Chlorothalonil
studies.
11,12
c
Application
rates
are
based
on
diuron
paint
labels
d
Amount
treated
is
based
on
assumptions
from
EPA's
Antimicrobial
Division
and
HED
Expo
SAC
Policy
#
9.1.9
e
Dermal
dose
(
mg/
kg/
day)
=
[(
unit
exposure
(
mg/
lb
ai)
*
Appl.
rate
(
lb
ai/
gallon)
*
gallons
handled)/
Body
weight
(
70
kg).
f
Inhalation
dose
(
mg/
kg/
day)
=
[
unit
exposure
(
F
g/
lb
ai)
*
0.001
mg/
F
g
unit
conversion
*
max
appl
rate
(
lb
ai/
gal)
*
gallons
handled]
/
Body
weight
(
70
kg).
g
MOE
=
NOAEL
(
mg/
kg/
day)
/
Daily
Dose
[
Intermediate
term
inhalation
NOAEL
=
1.0
mg/
kg/
day].
Target
MOE
is
100
for
occupational/
commercial.
81
Table
20:
Diuron
Cancer
Assessment
for
Antimicrobial
Uses
Exposure
Scenario
(
Scenario
#)
Clothing
Attire
Dermal
Unit
Exposure
(
mg/
lb
ai)
a
Inhalation
Unit
Exposure
(
F
g/
lb
ai)
b
Maximum
Application
Ratec
(
lb
ai/
gal)
Amount
Treatedd
Total
Absorbed
Dose
(
mg/
kg/
day)
e
LADD
(
mg/
kg/
day)
f
Riskg
Primary
Handlers
(
125
day/
year)
Mixing/
loading
of
Liquids
into
Paint
Products
(
1)
Open
pour,
long
pants,
long
sleeved
shirt,
chemical
resistant
gloves,
and
a
5
fold
PF
dust/
mist
type
respirator
0.184
1.7
0.0532
100
gal
6.9
E
4
1.2
E
4
2.3
E
6
1,000
gal
6.9
E
3
1.2
E
3
2.3
E
5
Loading
of
Tablets
into
Paint
Products
(
2)
0.412
11.8
0.0532
100
gallons
2.1
E
3
3.7
E
4
7.0
E
6
1,000
gallons
2.1
E
2
3.7
E
3
7.0
E
5
Secondary
Handlers
(
50
day/
year)
Applying
Paints
with
an
Airless
Sprayer
(
3)
Indoor
Long
pants,
long
sleeved
shirt,
and
a
5
fold
PF
dust/
mist
type
respirator
36.22
470
0.0532
50
gallons
7.3
E
2
5.0
E
3
9.5
E
5
Long
pants,
long
sleeved
shirt,
gloves,
and
a
5
fold
PF
dust/
mist
type
respirator
12
470
3.6
E
2
2.5
E
3
4.7
E
5
Outdoor
Long
pants,
long
sleeved
shirt,
and
a
5
fold
PF
dust/
mist
type
respirator
33.33
86.6
0.0532
50
gallons
5.4
E
2
3.7
E
3
7.1
E
5
Long
pants,
long
sleeved
shirt,
gloves,
and
a
5
fold
PF
dust/
mist
type
respirator
8.87
86.6
1.7
E
2
1.1
E
3
2.2
E
5
Applying
Paints
with
a
Paint
Brush
(
4)
Long
pants,
long
sleeved
shirt,
and
a
5
fold
PF
dust/
mist
type
respirator
290
101
0.0532
5
gallons
4.4
E
2
3.0
E
3
5.8
E
5
Footnotes:
a,
b
Dermal
and
inhalation
unit
exposures
are
from
CMA
and
Chlorothalonil
studies.
11,12
c
Application
rates
are
based
on
diuron
paint
labels
d
Amount
treated
is
based
on
assumptions
from
EPA's
Antimicrobial
Division
and
HED
Expo
SAC
Policy
#
9.1.9
e
Total
daily
absorbed
dose
(
mg/
kg/
day)
=
[(
dermal
dose
(
mg/
lb
ai)
*
dermal
absorption
(
4%)+
inhalation
dose
(
mg/
lb
ai)].
See
Table
6
for
the
corresponding
dermal
dose
and
inhalation
dose.
f
LADD
(
Lifetime
average
daily
dose)
mg/
kg/
day
=
Total
daily
absorbed
dose
(
mg/
kg/
day)
*
(
days
worked
per
year/
365
days
per
year)
*
(
35
years
worked/
70
year
lifetime).
Days
worked
per
year
are
estimates.
g
Risk
=
LADD
(
mg/
kg/
day)
*
Q1
*
=
1.91e
2
(
mg/
kg/
day)
1.
82
83
Table
21:
Short
Term
Baseline
Table
for
Algaecide
Use
in
Commercial
Fish
Production
Exposure
Scenario
(
Scenario
#)
Dermal
Unit
Exposure
(
mg/
lb
ai)
a
Inhalation
Unit
Exposure
(
F
g/
lb
ai)
b
Use
Application
Rate
c
Dermal
Dose
(
mg/
kg/
day)
d
Inhalation
Dose
(
mg/
kg/
day)
e
Inhalation
MOE
f
Mixer/
Loader
Mixing/
Loading
Dry
Flowables
(
1a)
0.066
0.77
Catfish
Production
7.5
lb
ai
per
day
0.0071
0.000083
120,000
Mixing/
Loading
Dry
Flowables
(
1b)
0.066
0.77
Ornamental
Fish
Production
819
lb
ai
per
day
0.77
0.0090
1,100
Mixing/
Loading
Wettable
Powders
(
2a)
3.7
43
Catfish
Production
7.5
lb
ai
per
day
0.40
0.0046
2,200
Mixing/
Loading
Wettable
Powders
(
2b)
3.7
43
Ornamental
Fish
Production
15.0
lb
ai
per
day
0.79
0.0092
1,100
Footnotes:
a
Baseline
dermal
exposure
represents
long
sleeves
and
long
pants.
b
Baseline
inhalation
unit
exposure
represents
no
respirator.
c
Application
Rates
are
based
on
the
diuron
commercial
fish
production
labels
and
EPA
estimates.
d
Daily
Dermal
Dose
(
mg/
kg/
day)
=
(
Dermal
Unit
Exposure
(
mg/
lb
ai)
x
Application
Rates
(
lb
ai/
A
and
lb
ai/
sq.
ft.)
x
Area
Treated
per
day
(
acres
and
square
feet))/
body
weight
(
70
kg).
e
Daily
Inhalation
dose
(
mg/
kg/
day)
=
(
Inhalation
Unit
Exposure
(
F
g/
lb
ai)
x
(
1mg/
1000
F
g)
Conversion
Factor
x
Application
Rate
(
lb
ai/
gallon)
x
Amount
Treated
per
day
(
gallons/
day))/
body
weight
(
70
kg).
f
Short
term
Inhalation
MOE
=
Inhalation
NOAEL
(
10
mg/
kg/
day)
/
Daily
Inhalation
Dose
(
mg/
kg/
day).
84
Table
22:
Cancer(
Q*)
Risk
Table
for
Algaecide
Use
in
Commercial
Fish
Production
Exposure
Scenario
(
Scenario
#)
Use
Applicatio
n
Rate
a
Exposure
s
Per
Yeara
Baselin
e
Total
Daily
Doseb
Baselin
e
Daily
LADDc
Baselin
e
Riskd
Max
PPE
Total
Daily
Doseb
Max
PPE
LADDc
Max
PPE
Riskd
Eng
Cont
Total
Daily
Doseb
Eng
Cont
LADDc
Eng
Cont
Riskd
Mixer/
Loader
Mixing/
Loading
Dry
Flowables
(
1a)
Catfish
Production
7.5
lb
ai
per
day
9
0.00037
4.50E
6
8.60E
8
0.00021
2.59E
6
4.94E
8
0.000007
2
8.85E
8
1.70E
9
Mixing/
Loading
Dry
Flowables
(
1b)
Ornamental
Fish
Production
819
lb
ai
per
day
3
0.040
1.64E
4
3.13E
6
0.023
9.41E
5
1.80E
6
0.00078
9.66E
6
1.85E
7
Mixing/
Loading
Wettable
Powders
(
2a)
Catfish
Production
7.5
lb
ai
per
day
9
0.020
2.52E
4
4.82E
6
0.0010
1.25E
5
2.40E
7
0.000068
8.35E
7
1.59E
8
Mixing/
Loading
Wettable
Powders
(
2b)
Ornamental
Fish
Production
15.0
lb
ai
per
day
9
0.041
5.05E
4
9.64E
6
0.0020
2.51E
5
4.79E
7
0.00014
1.67E
6
3.19E
8
Footnotes:
a
Based
on
diuron
commercial
fish
production
labels
and
EPA
estimates.
b
Total
Daily
Dose
(
mg/
kg/
day)
=
Daily
Dermal
Dose
(
mg/
kg/
day)
+
Daily
Inhalation
Dose
(
mg/
kg/
day).
See
Table
8
for
daily
dermal
and
inhalation
doses.
c
Lifetime
average
daily
dose
(
LADD)
(
mg/
kg/
day)
=
Average
Daily
Dose
(
mg/
kg/
day)
*
(
number
of
days
of
exposure
per
year
/
365
days/
year)
*
(
35
years
exposed
/
70
years
in
a
lifetime).
d
Cancer
risk
=
LADD
(
mg/
kg/
day)
*
Q1
(
1.91E
2
mg/
kg/
day1).
| epa | 2024-06-07T20:31:43.568427 | regulations | {
"license": "Public Domain",
"url": "https://downloads.regulations.gov/EPA-HQ-OPP-2002-0249-0009/content.txt"
} |
EPA-HQ-OPP-2002-0249-0010 | Supporting & Related Material | "2002-10-01T04:00:00" | null | MEMORANDUM
7/
29/
2001
SUBJECT:
Residue
Chemistry
Chapter
For
The
Diuron
Reregistration
Eligibility
Decision
(
RED)
Document.
DP
Barcode:
D274492
Chemical
No.
035505
Case
No:
0046
FROM:
John
S.
Punzi,
Ph.
D.,
Chemist
(
Signed
8/
7/
2001)
Reregistration
Branch
2
Health
Effects
Division
[
7509C]
THRU:
Alan
Nielsen,
Branch
Senior
Scientist
Reregistration
Branch
2
Health
Effects
Division
[
7509C]
TO:
Diana
Locke,
Ph.
D.,
Risk
Assessor
Reregistration
Branch
2
Health
Effects
Division
[
7509C]
Attached
is
the
Residue
Chemistry
Chapter
for
the
Diuron
Reregistration
Eligibility
Decision
(
RED)
document.
This
chapter
was
completed
by
the
Dynamac
Corporation
under
supervision
of
HED
and
has
undergone
secondary
review/
modification
in
Reregistration
Branch
2
for
consistency
with
current
EPA
policies.
This
document
was
reviewed
by
the
ChemSac
on
7/
25/
01
and
recommendations
have
been
incorporated.
The
existing
residue
chemistry
database
is
incomplete.
Label
revisions
are
required
for
many
crops
in
order
to
reflect
the
parameters
of
use
patterns
for
which
residue
data
are
available.
Many
of
the
revisions
concern
retreatment
intervals,
Preharvest
intervals
(
PHI's)
and
rotational
crop
restrictions.
The
qualitative
nature
of
the
residue
of
diuron
in
plants
and
animals
has
been
adequately
identified/
characterized.
The
Agency
is
recommending
that
the
tolerance
expression
for
diuron
be
revised
to
include
metabolites
hydrolyzable
to
3,4
dichloroaniline.
Adequate
analytical
methods
exist
for
data
collection
and
tolerance
enforcement
in
plants.
Independent
laboratory
validation
of
the
enforcement
method
is
required
for
livestock
methods
prior
to
Agency
validation.
Multiresidue
methods
for
diuron
and
metabolites
of
toxic
concern
are
required
for
plants
and
livestock.
Adequate
storage
stability
data
are
available
for
many
supported
crops.
Results
from
animal
feeding
studies
suggest
that
tolerances
are
necessary
for
poultry
or
egg
commodities
and
for
meats
and
milk.
Residue
data
are
not
available
for
several
potential
feed
items.
If
the
maximum
dietary
burden
does
not
increase
when
recalculated
from
all
potential
feed
items
after
acceptable
field
trial
data
are
submitted
then
the
established
tolerances
for
residues
in
fat,
meat,
and
meat
byproducts
of
cattle,
goats,
hogs,
horses,
and
sheep
can
be
lowered.
Adequate
residue
data
exist
for
some
processed
food/
feed
commodities.
The
reregistration
requirements
for
magnitude
of
the
residue
in
plants
are
not
fulfilled
for:
alfalfa
forage;
globe
artichoke;
barley
hay;
cotton
gin
byproducts;
field
corn
aspirated
grain
fractions;
field
corn
forage
and
stover;
filbert;
grass
forage,
hay,
seed
screenings,
and
straw;
lemon;
pear;
oat
forage,
hay;
olive;
field
pea
vines
and
hay;
sorghum
aspirated
grain
fractions,
stover,
and
forage;
wheat
forage
and
hay.
Additional
crop
field
trial
data
are
required
for
these
commodities.
The
reregistration
requirements
for
magnitude
of
the
residue
in
plants
are
fulfilled
for:
alfalfa
hay;
apple;
asparagus;
banana;
barley
grain,
straw;
blackberry;
blueberry;
clover
forage
and
hay;
field
corn
grain;
popcorn
grain
and
popcorn
stover;
cotton
seed;
gooseberry;
grape;
grapefruit;
loganberry;
macadamia
nut;
oat
grain
and
straw;
orange;
papaya;
field
pea
seed;
peach;
pecan;
peppermint;
pineapple;
raspberry;
sorghum
grain;
sugarcane;
trefoil
forage
and
hay;
vetch
forage
and
hay;
walnut;
and
wheat
grain,
aspirated
grain
fractions,
and
straw.
Adequate
field
trial
data
depicting
diuron
residues
of
concern
following
applications
made
according
to
the
maximum
registered
use
patterns
have
been
submitted
for
these
commodities
or
data
have
been
translated
from
appropriate
crops.
The
registrants
have
indicated
that
a
Section
3
tolerance
for
diuron
in/
on
catfish
is
desired.
Since
the
metabolism
committee
is
concerned
with
a
monochloronated
diuron
metabolite
identified
in
water,
a
metabolism
study
of
diuron
in
fish
is
required.
The
registrants
are
directed
to
OPPTS
860.1400
for
study
guidelines
and
encouraged
to
submit
a
study
protocol
prior
to
initiating
the
study.
Field
rotational
crop
trials
have
been
conducted
on
representative
crops
at
less
that
the
maximum
application
rates
with
1
year
plant
back
intervals
and
some
labels
indicate
a
2
year
plant
back
interval.
RRB2
recommends
that
the
registrants
provide
additional
data
to
support
the
higher
application
rate
and
believes
that
the
2
yr
PBI
is
not
practical.
The
registrants
should
remove
the
2
yr
PBI
from
the
registered
uses
and
provide
data
to
support
the
3.2
lb
ai/
A
application
rate
and
1
yr
PBI.
Until
adequate
data
are
supplied
labels
should
be
amended
to
restrict
rotational
crops
to
those
crops
which
currently
are
registered
as
primary
crops..
cc:
JSPunzi
(
RRB2),
Diuron
Reg.
Std.
File,
Diuron
SF,
RF,
LAN.
7509C:
RRB2:
John
S.
Punzi:
CM2:
Rm
712M:
703
305
7727:
07/
29/
2000.
Diuron
PC
Code
035505;
Case
0046
DP
Barcode
D274492
Reregistration
Eligibility
Decision;
Residue
Chemistry
Considerations
May
29,
2001
Contract
No.
68
W
99
053
Submitted
to:
U.
S.
Environmental
Protection
Agency
Arlington,
VA
Submitted
by:
Dynamac
Corporation
The
Dynamac
Building
2275
Research
Boulevard
Rockville,
MD
20850
3268
DIURON
REREGISTRATION
ELIGIBILITY
DECISION
RESIDUE
CHEMISTRY
CONSIDERATIONS
PC
Code
035505;
Case
0046
(
DP
Barcode
D274492)
TABLE
OF
CONTENTS
page
INTRODUCTION
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1
REGULATORY
BACKGROUND
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1
SUMMARY
OF
SCIENCE
FINDINGS
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2
GLN
860.1200:
Directions
for
Use
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2
GLN
860.1300:
Nature
of
the
Residue
Plants
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29
GLN
860.1300:
Nature
of
the
Residue
Livestock
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30
GLN
860.1340:
Residue
Analytical
Methods
Plants
and
Livestock
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32
GLN
860.1360:
Multiresidue
Methods
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33
GLN
860.1380:
Storage
Stability
Data
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33
Plant
commodities
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33
Livestock
commodities
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34
GLN
860.1500:
Crop
Field
Trials
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34
Legume
Vegetables
Group
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35
Pea,
field,
seed
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35
Foliage
of
Legume
Vegetables
Group
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35
Pea,
field,
vines
and
hay
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35
Citrus
Fruit
Group
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36
Grapefruit
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36
Lemon
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36
Orange
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36
Pome
Fruit
Group
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36
Apple
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36
Pear
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36
Stone
Fruit
Group
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37
Peach
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37
Berry
Group
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37
Blackberry
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37
Blueberry
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37
Gooseberry
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37
Loganberry
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37
Table
of
Contents
(
continued)
page
v
Raspberry
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37
Tree
Nut
Group
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38
Filbert
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38
Macadamia
nut
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.
38
Pecan
.
.
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.
38
Walnut
.
.
.
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.
38
Cereal
Grains
Group
.
.
.
.
.
.
.
.
.
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.
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.
.
.
.
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.
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.
.
38
Barley,
grain
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
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.
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.
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.
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.
.
.
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.
.
.
.
.
38
Corn,
field,
grain
and
aspirated
grain
fractions
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
38
Corn,
pop,
grain
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
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.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
39
Corn,
sweet,
K+
CWHR
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
39
Oat,
grain
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
39
Sorghum,
grain
and
aspirated
grain
fractions
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
39
Wheat,
grain
and
aspirated
grain
fractions
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
39
Forage,
Fodder,
and
Straw
of
Cereal
Grains
Group
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
40
Barley,
hay
and
straw
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
40
Corn,
field,
forage
and
stover
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
40
Corn,
pop,
stover
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
40
Corn,
sweet,
forage
and
stover
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
40
Oat,
forage,
hay,
and
straw
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
40
Sorghum,
forage
and
stover
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
40
Wheat,
forage,
hay,
and
straw
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
41
Grass
Forage,
Fodder,
and
Hay
Group
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
41
Grass,
forage,
hay,
seed
screenings,
and
seed
straw
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
41
Nongrass
Livestock
Feeds
(
Forage,
Fodder,
Hay,
and
Straw)
Group
.
.
.
.
.
.
.
.
.
.
.
.
.
42
Alfalfa,
forage
and
hay
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
42
Clover,
forage
and
hay
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
42
Trefoil,
forage
and
hay
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
42
Vetch,
forage
and
hay
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
42
Miscellaneous
Commodities
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
43
Artichoke,
globe
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
43
Asparagus
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
43
Banana
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
43
Cotton,
seed
and
gin
byproducts
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
43
Grape
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
44
Olive
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
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.
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.
.
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.
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.
.
.
.
.
44
Papaya
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
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.
.
.
.
.
.
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.
.
.
.
.
.
.
.
.
.
.
44
Peppermint
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
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.
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.
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.
.
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.
.
.
.
.
44
Pineapple
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
45
Sugarcane
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
45
Table
of
Contents
(
continued)
page
vi
GLN
860.1520:
Processed
Food/
Feed
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
45
Apple
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
45
Barley
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
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.
.
.
.
.
.
.
.
.
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.
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.
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.
.
.
.
.
45
Citrus
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
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.
.
.
.
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.
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.
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.
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.
.
.
.
.
.
.
46
Corn,
field
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
46
Cottonseed
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
46
Grape
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
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.
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.
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.
.
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.
.
.
.
.
.
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.
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.
.
.
.
.
.
.
46
Mint
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
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.
.
.
.
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.
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.
.
.
.
.
46
Oats
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
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.
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.
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.
.
.
.
.
.
.
.
46
Olive
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
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.
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.
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.
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.
.
.
.
.
46
Pineapple
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
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.
.
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.
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.
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.
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.
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.
.
.
.
.
.
.
46
Sugarcane
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
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.
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.
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.
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.
.
.
47
Wheat
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
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.
.
.
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.
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.
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.
.
.
.
.
.
.
.
.
47
GLN
860.1480:
Meat,
Milk,
Poultry,
and
Eggs
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
47
GLN
860.1400:
Water,
Fish,
and
Irrigated
Crops
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
49
GLN
860.1460:
Food
Handling
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
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.
.
50
GLN
860.1850
and
860.1900:
Confined/
Field
Accumulation
in
Rotational
Crops
.
.
.
.
.
.
.
.
.
50
TOLERANCE
REASSESSMENT
SUMMARY
.
.
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.
.
60
Tolerances
Listed
Under
40
CFR
§
180.106(
a)
.
.
.
.
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.
60
Tolerances
To
Be
Proposed
Under
40
CFR
§
180.106(
a)
.
.
.
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.
61
Tolerances
Listed
Under
40
CFR
§
180.106(
b)
.
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.
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.
61
Tolerances
To
Be
Proposed
Under
40
CFR
§
180.106(
c)
.
.
.
.
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61
Pending
Tolerance
Petitions
.
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61
INTERNATIONAL
HARMONIZATION
.
.
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68
AGENCY
MEMORANDA
RELEVANT
TO
REREGISTRATION
.
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69
MASTER
RECORD
IDENTIFICATION
NUMBERS
.
.
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.
77
DIURON
REREGISTRATION
ELIGIBILITY
DECISION
RESIDUE
CHEMISTRY
CONSIDERATIONS
PC
Code
035505;
Case
0046
INTRODUCTION
Diuron
[
3(
3,4
dichlorophenyl)
1,1
dimethylurea]
is
an
herbicide
currently
registered
for
use
on
a
variety
of
fruit,
vegetable,
nut,
and
field
crops
including
alfalfa,
apple,
artichoke,
asparagus,
banana
and
plantain,
winter
barley,
bermudagrass,
blueberry,
caneberry,
citrus,
red
clover,
field
corn,
cotton,
filbert,
gooseberry,
grape,
grass
seed
crops,
macadamia
nut,
oats,
olive,
papaya,
field
pea,
peach,
pear,
pecan,
peppermint,
pineapple,
grain
sorghum,
sugarcane,
trefoil,
walnut,
and
winter
wheat.
The
reregistration
of
diuron
is
being
supported
by
Griffin
Corporation,
E.
I.
du
Pont
de
Nemours
and
Company,
Drexel
Chemical
Company,
and
Aventis
CropScience
USA.
The
diuron
formulation
classes
registered
to
these
companies
for
food/
feed
uses
include
the
wettable
powder
(
WP),
emulsifiable
concentrate
(
EC),
dry
flowable
(
DF),
and
flowable
concentrate
(
FlC).
These
formulations
are
typically
applied
as
preplant,
preemergence,
soil
directed,
or
postemergence
treatments
using
ground
or
aerial
equipment.
REGULATORY
BACKGROUND
Diuron
was
the
subject
of
a
Reregistration
Standard
Guidance
Document
dated
9/
83;
the
Residue
Chemistry
Science
Chapter
of
the
Guidance
Document
was
dated
6/
25/
82.
The
Residue
Chemistry
Chapter
Update
of
the
Diuron
Reregistration
Standard
was
issued
on
3/
9/
92.
These
documents
summarized
the
available
residue
chemistry
data
and
specified
reregistration
requirements
in
support
of
food/
feed
uses.
Several
data
submissions
have
been
received
and
evaluated
since
the
Update.
The
information
contained
in
this
document
outlines
the
Residue
Chemistry
Science
Assessments
with
respect
to
the
reregistration
of
diuron.
We
note
that
although
Du
Pont
was
the
primary
registrant
of
diuron
when
the
Update
was
issued,
Du
Pont
has
since
transferred,
cancelled,
or
substantially
reduced
its
registered
uses
of
diuron;
Griffin
LLC
is
now
the
primary
registrant
of
diuron,
and
is
taking
the
lead
in
a
data
sharing
agreement
with
the
other
diuron
registrants.
Diuron
has
been
classified
as
a
"
known/
likely"
human
carcinogen
by
all
routes.
Tolerances
for
residues
of
diuron
in/
on
plant
and
livestock
commodities
are
established
under
40
CFR
§
180.106.
Diuron
tolerances
are
expressed
as
diuron
per
se.
HED
is
now
recommending
that
the
tolerance
expression
for
diuron
be
revised
to
include
metabolites
hydrolyzable
to
3,4
dichloroaniline
(
3,4
DCA).
This
determination
is
based
on
the
results
of
the
reviewed
plant
and
livestock
metabolism
2
1.
Date
of
the
most
recently
EPA
approved
label
found
in
the
Pesticide
Product
Label
System
(
PPLS).
2.
This
product
is
a
multiple
active
ingredient
(
MAI)
product,
containing
thidiazuron
at
1
lb/
gal.
3.
This
product
is
an
MAI
product,
containing
thidiazuron
at
50%.
4.
This
product
is
an
MAI
product,
containing
bromacil
at
40%.
5.
Including
SLN
LA980002.
6.
Including
SLN
LA980003
and
TX000011.
7.
Including
SLN
OR950032.
studies.
Adequate
residue
analytical
methods
are
available
for
determination
of
diuron
total
toxic
residues.
GLN
860.1200:
Directions
for
Use
A
search
of
the
Agency's
REFS
database,
conducted
on
2/
8/
01,
identified
seven
active
diuron
end
use
products
(
EPs)
registered
to
diuron
data
submitters
under
FIFRA
Section
3
for
use
on
food/
feed
crops.
These
EPs,
including
the
associated
Special
Local
Need
(
SLN)
registrations
under
FIFRA
Section
24
(
c),
are
listed
in
Table
A1.
Table
A1.
Diuron
EPs
with
Food/
Feed
Uses
Registered
to
Diuron
Data
Submitters.
EPA
Reg.
No.
Label
Acceptance
Date1
Formulation
Product
Name
Aventis
CropScience
USA
264
634
4/
14/
98
0.5
lb/
gal
EC2
Ginstar
®
EC
Cotton
Defoliant
264
661
6/
18/
96
25%
WP3
Dropp
®
Ultra
Cotton
Defoliant
E.
I.
du
Pont
de
Nemours
and
Co.
352
505
7/
1/
99
40%
DF4
Krovar
®
I
DF
Herbicide
Griffin
Corporation
1812
2575
3/
15/
01
4
lb/
gal
FlC
Direx
4L
®
Herbicide
1812
3626
3/
15/
01
80%
DF
Karmex
®
DF
Herbicide
Drexel
Chemical
Company
19713
36
3/
15/
01
4
lb/
gal
FlC
Diuron
4L
Herbicide
19713
2747
11/
30/
00
80%
WP
Diuron
80
Herbicide
A
comprehensive
summary
of
diuron
food/
feed
use
patterns,
based
on
the
registered
product
labels
of
the
diuron
data
submitters,
is
presented
in
Table
A2.
A
tabular
summary
of
the
residue
chemistry
science
assessments
for
reregistration
of
diuron
is
presented
in
Table
B.
The
status
of
reregistration
requirements
for
each
guideline
topic
listed
in
Table
B
3
is
based
on
the
use
patterns
registered
to
the
members
of
the
Diuron
Task
Force,
the
basic
registrants.
When
end
use
product
DCIs
are
developed
(
e.
g.,
at
issuance
of
the
RED),
RD
should
require
that
all
end
use
product
labels
(
e.
g.,
MAI
labels,
SLNs,
and
products
subject
to
the
generic
data
exemption)
be
amended
such
that
they
are
consistent
with
the
labels
of
the
basic
registrants.
For
the
purpose
of
generating
this
Residue
Chemistry
Chapter,
the
Agency
compared
the
diuron
food/
feed
uses
currently
registered
to
Griffin,
Drexel,
Du
Pont,
and
Aventis
(
Table
A2)
with
the
available
crop
field
trial
data.
As
a
result,
label
amendments
are
required
for
some
formulations,
as
specified
below.
For
apple,
the
label
for
the
4
lb/
gal
FlC
[
EPA
Reg.
No.
19713
36]
formulation
must
be
amended
to
correct
an
apparent
typographical
error.
The
label
currently
states
"
Apply
4
pounds
per
acre
in
the
Spring;"
this
should
be
modified
to
state
"
Apply
3.2
quarts
per
acre
in
the
Spring."
Once
corrected,
the
maximum
application
rate
for
apples
will
be
3.2
lb
ai/
A,
which
is
the
maximum
rate
supported
by
available
field
trial
data.
For
banana,
the
labels
for
the
4
lb/
gal
FlC
[
EPA
Reg.
Nos.
1812
257
and
19713
36],
80%
DF
[
EPA
Reg.
No.
1812
362]
and
80%
WP
[
EPA
Reg.
No.
19713
274]
formulations
must
be
modified
to
specify
that
application
may
only
be
made
to
bananas
grown
in
HI.
For
citrus
fruits,
the
product
labels
for
the
4
lb/
gal
FlC
[
EPA
Reg.
Nos.
1812
257
and
19713
36],
40%
DF
[
EPA
Reg.
No.
352
505],
80%
DF
[
EPA
Reg.
No.
1812
362]
and
80%
WP
[
EPA
Reg.
No.
19713
274]
formulations
must
be
modified
to
specify
the
following
maximum
seasonal
application
rates:
6.4
lb
ai/
A
for
FL
and
PR,
and
3.2
lb
ai/
A
for
all
other
areas.
For
corn,
the
labels
for
the
4
lb/
gal
FlC
[
EPA
Reg.
Nos.
1812
257
and
19713
36],
80%
DF
[
EPA
Reg.
No.
1812
362],
and
80%
WP
[
EPA
Reg.
No.
19713
274]
formulations
must
be
amended
to
make
it
clear,
under
the
use
directions
for
"
Corn
(
field)"
that
application
is
only
to
be
made
to
field
corn
or
popcorn.
For
cotton,
the
labels
for
the
4
lb/
gal
FlC
[
EPA
Reg.
Nos.
1812
257
and
19713
36],
80%
DF
[
EPA
Reg.
No.
1812
362],
and
80%
WP
[
EPA
Reg.
No.
19713
274]
formulations
must
be
amended
to
remove
the
maximum
seasonal
rate
for
application
to
cotton
in
loamy
sand
soils
because
the
labels
also
state
that
application
should
not
be
made
to
loamy
sand
soils.
For
cotton,
the
labels
for
the
25%
WP
[
EPA
Reg.
No.
264
661]
and
0.5
lb/
gal
EC
[
EPA
Reg.
No.
264
634]
formulations
must
be
modified
to
remove
the
restriction
against
the
feeding
of
cotton
gin
byproducts
to
livestock.
The
Agency
does
not
believe
that
this
restriction
is
practical.
For
grass
seed
crops,
current
product
labels
allow
application
at
up
3.2
lb
ai/
A
in
the
fall
or
up
to
2.4
3.2
lb
ai/
A
in
the
spring
(
depending
on
geographical
location).
No
data
reflecting
spring
application
at
4
2.4
3.2
lb
ai/
A
are
available.
The
registrants
must
modify
product
labels
to
specify
a
maximum
application
rate
of
1.6
lb
ai/
A
for
spring
applications.
Alternatively,
crop
field
trial
data
reflecting
spring
application
at
2.4
3.2
lb
ai/
A
may
be
submitted.
For
winter
wheat,
the
labels
for
the
4
lb/
gal
FlC
[
EPA
Reg.
No.
1812
257]
and
the
80%
DF
[
EPA
Reg.
No.
1812
362]
formulations
must
be
modified.
The
heading
"
Other
Areas
of
Oregon
and
Washington"
should
be
modified
to
state
"
Other
Areas."
The
products
labels
for
EPA
Reg.
Nos.
19713
36
and
19713
274
include
use
directions
for
Bermudagrass.
The
use
of
diuron
on
Bermudagrass
is
not
supported
by
field
trial
data
or
any
tolerances.
Tolerances
for
diuron
residues
in
Bermudagrass
forage
and
hay
had
previously
been
established;
however,
these
tolerances
were
revoked
in
1998.
The
use
directions
for
Bermudagrass
must
be
removed
from
the
product
labels
for
EPA
Reg.
Nos.
19713
36
and
19713
274.
SLN
CA850060
is
associated
with
EPA
Reg.
No.
254
247,
a
diuron
product
that
was
canceled
in
1996.
In
addition,
the
use
on
SLN
CA850060
is
a
use
on
lakes,
ponds,
holding
basins,
and
other
similar
sites
which
may
be
used
for
irrigation.
No
data
to
support
these
uses
are
available;
therefore,
SLN
CA850060
should
be
canceled.
Rotational
crop
restrictions
should
be
made
consistent
between
various
formulations.
A
2
year
plant
back
interval
may
not
be
practical
unless
phytotoxicity
is
a
concern.
| epa | 2024-06-07T20:31:43.597769 | regulations | {
"license": "Public Domain",
"url": "https://downloads.regulations.gov/EPA-HQ-OPP-2002-0249-0010/content.txt"
} |
EPA-HQ-OPP-2002-0249-0011 | Supporting & Related Material | "2002-10-01T04:00:00" | null | 6/
26/
01
MEMORANDUM
SUBJECT:
Diuron.
List
A
Reregistration
Case
0046.
PC
Code
035505.
Product
Chemistry
Chapter
for
the
Reregistration
Eligibility
Decision
[
RED]
Document.
DP
Barcode
D274489.
FROM:
K.
Dockter,
Chemist
Reregistration
Branch
2
Health
Effects
Division
[
7509C]
THRU:
Alan
Nielsen,
Branch
Senior
Scientist
Reregistration
Branch
2
Health
Effects
Division
[
7509C]
TO:
Diana
Locke,
Ph.
D.,
Risk
Assessor
Reregistration
Branch
2
Health
Effects
Division
[
7509C]
Diuron
[
3(
3,4
dichlorophenyl)
1,1
dimethylurea]
is
registered
for
selective
and
total
weed
control
in
crops
such
as:
alfalfa,
asparagus,
citrus,
cotton,
orchards,
sugar
cane,
wheat,
and
vineyards.
Empirical
formula:
C
9H10Cl
2N2O
Molecular
weight:
233.1
CAS
Registry
No.:
330
54
1
PC
Code:
035505
Chemical
structure
by
J.
Punzi
2
A
search
of
REFS
conducted
4/
26/
01
identified
95
active
diuron
products;
6
of
which
are
technicals
or
manufacturing
use
products,
which
are
subject
to
a
RED.
They
are
identified
in
Table
1.
Table
1.
Technical
Diuron
Active
Products
EPA
Reg.
No.
CSF*
Date
Registrant
Product
Name
%
a.
i.
1812
4121
10/
30/
97
Griffin
L.
L.
C.
Dupont
Diuron
Technical
Herbicide
98.4
19713
66
2/
15/
95
Drexel
Chml.
Co.
Drexel
Diuron
Technical
98.0
19713
2752
1/
6/
89
"
Diuron
Technical
97.
67640
XX(
E)
2
10/
24/
95
Sanachem
U.
S.
A.,
Inc.
"
98.8
12020
1
8/
26/
86
Staveley
Chmls.
Ltd.
"
99.25
46120
13
1/
26/
84
United
Phosphorus
Europe
Ltd.
"
Herbicide
98
*
Confidential
Statement
of
Formula.
1
Transferred
from
Dupont
352
324
on
4/
8/
98.
2
Transferred
from
IDA,
INC.
45115
27
CSF
dated
1/
6/
89,
RD
scanned
4/
15/
92.
3
Transferred
from
Aceto
Agric.
Chmls.
Corp.
2749
58
on
5/
24/
90.
The
product
chemistry
data
base
is
not
complete;
new
CSFs
are
required
which
reflect
preliminary
analyses
of
current
products
together
with
discussions
of
formation
of
impurities.
The
available
Generic
Series
830
physical
and
chemical
properties
are
given
in
Table
2.
3
Table
2.
Generic
Series
830
Physical
and
Chemical
Properties
GLN
MRID
Data
6302
Color
net1
white
6303
Physical
state
"
crystal
6304
Odor
"
none
7200
MP
"
158
9
C
7840
Water
solubility
"
42
ppm
@
25
C
7950
vp
"
2x10
7
mm
Hg
@
30
C
7550
Log
Pow
2
2.68
6320
Corrosion
characteristics
43842201
not
corrosive
6313
Stability
to
normal
and
elevated
temperatures,
metals,
and
metal
ions
"
stable
for
2
Yrs.
in
double
polyethylene
bag
inside
a
fiber
drum
under
warehouse
conditions.
Metals
and
metal
ion
data
not
given.
7050
UV/
Visible
absorption
NG
NG:
Not
Given.
Bibliography
1
Diuron.
CASRN:
330
54
1.
http://
toxnet.
nlm.
nih.
gov/
egi
bin/
sis/
search.
2
Reddy,
K.
N.
and
M.
A.
Locke.
1996.
Molecular
Properties
as
Descriptors
of
Octanol
Water
Partition
Coefficients
of
Herbicides.
Water,
Air
and
Soil
Pollution
Vol.
86:
pp
389
405.
cc:
Reg.
Std.
F,
SF,
RF,
Dockter,
J.
Punzi,
R.
Sandvig,
C.
Jarvis,
Y.
Yang,
R.
Allen.
RD\
I
Diuron
RED
Team.
7509C:
RRB2:
Rm712G:
57886:
KD/
kd
Diuron
RED
[
983Sr8]
=
D274489.
mem.
| epa | 2024-06-07T20:31:43.607036 | regulations | {
"license": "Public Domain",
"url": "https://downloads.regulations.gov/EPA-HQ-OPP-2002-0249-0011/content.txt"
} |
EPA-HQ-OPP-2002-0249-0012 | Supporting & Related Material | "2002-10-01T04:00:00" | null | UNITED
STATES
ENVIRONMENTAL
PROTECTION
AGENCY
WASHINGTON,
D.
C.
20460
OFFICE
OF
PREVENTION,
PESTICIDES
AND
TOXIC
SUBSTANCES
09/
10/
2001
MEMORANDUM
SUBJECT:
Diuron
Chronic
Dietary
Exposure
Assessment
(
PC
Code
035505);
DP
Barcode
D276683;
Case
0046.
FROM:
John
S.
Punzi,
Ph.
D.,
Chemist
Reregistration
Branch
II
Health
Effects
Division
(
7509C)
THROUGH:
Alan
Nielsen,
Branch
Senior
Scientist
Reregistration
Branch
II
Health
Effects
Division
(
7509C)
Dietary
Exposure
Science
Advisory
Council
(
DE
SAC)
Health
Effects
Division
(
7509C)
TO:
Diana
Locke,
Ph.
D.,
Risk
Assessor
Reregistration
Branch
II
Health
Effects
Division
(
7509C)
Executive
Summary
This
chronic
dietary
exposure
assessment
was
conducted
for
the
herbicide
diuron
to
estimate
the
dietary
risk
associated
with
registered
uses
of
this
product.
Diuron
is
used
on
a
wide
variety
of
food
and
feed
crops.
Residue
levels
from
USDA
and
FDA
monitoring
programs
do
not
include
all
residues
of
concern
needed
for
this
assessment
(
diuron
and
metabolites
converted
to
3,4
DCA)
and
would
be
inappropriate
for
this
analysis.
Anticipated
residues
(
ARs)
from
field
trial
data
were
utilized
to
estimate
the
dietary
exposure
to
diuron
from
the
diets
of
the
U.
S.
population,
as
well
as
certain
population
subgroups.
These
ARs
were
developed
previously
(
D250038,
R.
Loranger,
10/
08/
1998,
and
D169227,
C.
Swartz
02/
13/
1992).
With
the
exception
of
residue
data
from
processing
of
sugarcane
into
refined
sugar
and
molasses,
the
only
refinements
to
the
residue
data
are
the
use
of
averaged
percent
crop
treated
(%
CT)
information
(
BEAD
email
messages
from
Rafael
Prieto
6/
14/
2001
and
Alan
Halverson,
4/
27/
2001).
Estimated
chronic
dietary
risks
associated
with
the
use
of
diuron
do
not
exceed
HED's
level
of
concern
(>
100%
cPAD)
for
the
US
population
or
any
population
subgroup
examined.
The
chronic
dietary
2
risk
estimates
for
the
US
population
and
children
aged
1
6
years
(
the
highest
exposed
group)
are
approximately
3%
and
7%
cPAD,
respectively.
Approximately
40%
of
the
exposure
to
diuron
from
food
is
from
orange
juice
and
orange
juice
concentrate.
The
registrants
have
committed
to
label
changes
which
would
restrict
the
application
of
diuron
to
asparagus
plantings
prior
to
appearance
of
spears.
Residues
of
diuron
in/
on
asparagus
are
reduced
by
approximately
one
order
of
magnitude
(
from
2.8
to
0.26
ppm)
by
this
proposed
use.
To
examine
the
effect
of
the
residue
value
on
the
dietary
exposure,
calculations
were
performed
using
residues
levels
reflecting
treatment
of
asparagus
crops
before
and
after
spears
appear.
There
were
minimal
changes
in
the
chronic
exposure
estimates
using
data
from
the
pre
emergence
or
post
emergence
applications
of
diuron
to
asparagus.
Estimated
cancer
risk
from
exposure
to
diuron
from
food
exceeds
HED's
level
of
concern
(>
1.0x10
6)
for
the
US
population.
The
lifetime
cancer
risk
for
the
US
population
is
approximately
2x10
6.
Toxicological
Information
On
June
18,
2001,
the
Hazard
Identification
Assessment
Review
Committee
(
HIARC)
met
to
discuss
acute
and
chronic
hazard
endpoint
selection
for
dietary
exposure
to
diuron
(
Table
1).
In
a
meeting
on
August
7,
2001,
the
Food
Quality
Protection
Act
(
FQPA)
Safety
Factor
Committee
recommended
that
the
10X
FQPA
Safety
Factor
(
as
required
by
Food
Quality
Protection
Act
of
August
3,
1996)
be
reduced
to
1X
in
assessing
the
potential
risks
posed
by
diuron
use
(
B.
Tarplee
memo,
09/
01/
01).
Chronic
and
Cancer
Endpoints:
Table
1:
Doses
and
Endpoints
Selected
for
Chronic
Dietary
Risk
Assessment
EXPOSURE
SCENARIO
DOSE
(
mg/
kg/
day)
ENDPOINT
Acute
Dietary
No
appropriate
endpoint
attributed
to
a
single
dose
was
identified;
therefore,
an
acute
RfD
was
not
established.
Chronic
Dietary
LOAEL
=
1.0
UF
=
300
FQPA=
1x
Evidence
of
hemolytic
anemia
and
compensatory
hematopoiesis.
CPAD=
Chronic
RfD
=
0.003
mg/
kg/
day
Cancer
Known/
likely
human
carcinogen
Q*=
1.191x10
2.
Urinary
bladder
carcinoma
in
both
sexes
of
the
Wistar
rat,
kidney
carcinomas
in
the
male
rat
(
a
rare
tumor),
and
mammary
gland
carcinomas
in
the
female
NMRI
mouse.
3
Consumption
Data
and
Dietary
Risk
Analysis
The
diuron
chronic
dietary
exposure
assessment
was
conducted
using
the
Dietary
Exposure
Evaluation
Model
(
DEEM
)
software
Version
7.73,
which
incorporates
consumption
data
from
USDA's
Continuing
Surveys
of
Food
Intake
by
Individuals
(
CSFII),
1989
1992.
The
1989
92
data
are
based
on
the
reported
consumption
of
more
than
10,000
individuals
over
three
consecutive
days,
and
therefore
represent
more
than
30,000
unique
"
person
days"
of
data.
Foods
"
as
consumed"
(
e.
g.,
apple
pie)
are
linked
to
raw
agricultural
commodities
and
their
food
forms
(
e.
g.,
apples
cooked/
canned
or
wheat
flour)
by
proprietary
recipe
translation
files
within
DEEM.
Consumption
data
are
averaged
for
the
entire
US
population
and
within
population
subgroups
for
chronic
exposure
assessment.
For
chronic
exposure
and
risk
assessment,
an
estimate
of
the
residue
level
in
each
food
or
food
form
(
e.
g.,
orange
or
orange
juice)
on
the
commodity
residue
list
is
multiplied
by
the
average
daily
consumption
estimate
for
that
food/
food
form.
The
resulting
residue
consumption
estimate
for
each
food/
food
form
is
summed
with
the
residue
consumption
estimates
for
all
other
food/
food
forms
on
the
commodity
residue
list
to
arrive
at
the
total
estimated
exposure.
Exposure
estimates
are
expressed
in
mg/
kg
body
weight/
day
and
as
a
percent
of
the
cPAD.
Residue
Information
Diuron
Use:
Diuron
is
a
substituted
urea
herbicide
used
for
the
control
of
a
wide
variety
of
annual
and
perennial
broadleaves
and
grassy
weeds
on
both
crop
and
noncrop
sites.
Its
main
use
is
as
a
pre
emergent,
soil
applied
herbicide,
but
it
can
also
be
used
to
control
emerged
weeds.
Diuron
formulation
classes
registered
for
food/
feed
uses
include
wettable
powder,
emulsifiable
concentrate,
dry
flowable,
and
flowable
concentrate.
These
formulations
are
typically
applied
preplant,
preemergence,
soil
directed,
or
postemergence
treatments
using
ground
or
aerial
equipment.
Tolerances
have
been
established
for
a
number
of
commodities
and
are
listed
in
40
CFR
§
180.106.
Anticipated
residues
from
field
trial
data
were
utilized
to
estimate
the
dietary
exposure
to
diuron
from
the
diets
of
the
U.
S.
population,
as
well
as
certain
population
subgroups.
These
ARs
were
developed
previously
(
D250038,
R.
Loranger,
10/
08/
1998,
and
D169227,
C.
Swartz
02/
13/
1992).
With
the
exception
of
residue
data
from
processing
of
sugarcane
into
refined
sugar
and
molasses,
the
only
refinements
to
the
residue
data
are
the
use
of
average
%
CT
information
(
BEAD
email
messages
from
Rafael
Prieto
6/
14/
2001
and
Alan
Halvorson,
4/
27/
2001).
4
Table
2.
Anticipated
Residues
to
be
Used
in
Chronic
Dietary
Assessment
Commodity
Reassesse
d
Tolerance
Weighted
Average
%
CT
Anticipated
Residue
Apples
0.10
13
0.016*
Juice
13
use
DEEM
default
Artichokes
TBD(
1)
2***
0.3**
Asparagus
7.0
53
2.8**
Asparagus
(
preemergence
use)
TBD
53
0.26**
Banana
0.05
14***
0.025**
Barley
grain
0.20
1
0.20
Barley
bran
1
0.30
Birdsfoot
trefoil
TBD(
0.1)
1
Blackberries
0.10
53
0.10
Blueberries
0.10
29
0.10
Boysenberries
0.10
7
0.10
Cattle,
fat
TBD(
1)
100
0.000003**
Cattle,
meat
TBD(
1)
100
0.000001**
Cattle,
meat
byproducts
TBD(
1)
Liver
100
0.00005**
Kidney
100
0.000026**
Grapefruit
TBD(
1)
47
0.012**
Lemons
TBD(
1)
26
0.05*
5
Oranges
TBD(
1)
51
0.030**
Oranges,
juice
51
default**
Limes
TBD(
1)
33
0.05*
Tangelos
TBD(
1)
47
0.05*
Tangerine
TBD(
1)
30
0.05*
Temples
TBD(
1)
51
0.05*
Citrus
oil
TBD(
21x)
Corn,
grain,
pop
0.01
1
0.086*
Corn,
grain,
field
0.01
1
0.086*
Cottonseed
0.20
11
0.02
oil**/
0.1
meal**
Currants
0.10
32
0.10
Dewberries
0.10
53
0.10
Eggs
whole
yolks
whites
0.05
100
0.00026**
0.00069**
0.000027**
Goats,
fat
TBD(
1)
see
cattle
Goats,
meat
TBD(
1)
see
cattle
Goats,
meat
byproducts
TBD(
1)
see
cattle
Gooseberries
0.10
32
0.10
Grapes
0.05
10
0.021*
Grapes,
juice
and
raisins
10
0.021**
Hogs,
fat
TBD(
1)
100
see
cattle
Hogs,
meat
TBD(
1)
100
see
cattle
Hogs,
meat
byproducts
TBD(
1)
100
see
cattle
6
Horses,
fat
TBD(
1)
100
see
cattle
Horses,
meat
TBD(
1)
100
see
cattle
Horses,
meat
byproducts
TBD(
1)
100
see
cattle
Huckelberries
0.10
29
0.10
Loganberries
0.10
33***
0.10
Nuts
0.10
Almonds
0.10
1
0.10
Filberts
TBD
14
0.10
Macadamia/
pistachio
0.10
5
0.10
Pecans
0.10
3
0.10
Walnuts
0.10
12
0.10
Milk
TBD
0.000058**
Oat,
grain
0.10
1
0.10
Olives
TBD
(
1)
24
1.0/
1.0
oil
Papayas
0.50
13***
0.50
Peaches
0.10
10
0.10
Pears
TBD(
1)
9
0.016*
Peas
0.10
1***
0.10
Peppermint
hay
1.5
41
1.5
Pineapple
0.1
13***
0.1/
0.07
juice
Poultry
meat
by
products
TBD
100
0.00017**
Raspberries
0.10
13
0.10
Sheep,
fat
TBD(
1)
100
see
cattle
Sheep,
meat
TBD(
1)
100
see
cattle
Sheep,
meat
byproducts
TBD(
1)
100
see
cattle
7
Sorghum,
grain
0.50
1
0.134*
Sugarcane
0.20
4
0.027*
Refined
sugar
0.00018*
Molasses
0.088*
Vetch
2
1
2
Wheat,
grain
0.50
1
0.136**
Wheat,
bran
0.70
0.30**
Wheat,
flour
0.019**
section
18
Catfish
fillet
2
35***
2
Footnotes:
Anticipated
residues
based
on
tolerances
or
taken
from
D169227,
02/
13/
1992,
C.
Swartz
as
indicated
by
(*)
or
D250038,
10/
08/
1998,
R.
Loranger
as
indicated
by
**.
%
Crop
treated
data
were
obtained
from
a
Lotus
notes
link
to
a
QUA
supplied
by
BEAD
via
email
(
6/
14/
2001)
and
supplemented
with
data
from
Alan
Halvorson,
BEAD/
EAB,
04/
27/
2001
as
indicated
by
(***)..
TBD
To
be
determined.
Results
and
Discussion
Chronic
Dietary
Exposure
Analysis:
A
chronic
dietary
exposure
analysis
for
diuron
was
performed
utilizing
DEEMTM
exposure
modeling
software.
The
input
values
include
the
anticipated
residues
incorporating
%
CT
and
processing
factors
for
commodities
on
which
diuron
is
used.
The
calculated
chronic
exposure
(
residue
x
consumption)
was
compared
to
a
cPAD
of
0.003
mg/
kg/
day,
which
reflects
a
FQPA
factor
of
1X.
The
results
of
the
chronic
dietary
analysis
are
presented
in
Table
3.
Estimated
chronic
dietary
risk
associated
with
the
use
of
diuron
do
not
exceed
HED's
level
of
concern
(>
100%
cPAD)
for
any
population
subgroup
examined.
The
chronic
dietary
risk
estimates
for
the
U.
S.
population
and
children
aged
1
6
years
are
approximately
3%
and
7%,
respectively,
of
the
cPAD.
Approximately
40
%
of
the
exposure
to
diuron
from
food
is
from
orange
juice
and
orange
juice
concentrate.
The
registrants
have
committed
to
label
changes
for
the
application
of
diuron
to
asparagus.
There
were
8
minimal
changes
in
the
chronic
exposure
estimates
using
data
from
the
preemergence
or
postemergence
applications
of
diuron
to
asparagus
(
Table
3).
Cancer
Dietary
Exposure
Analysis:
Estimated
cancer
risk
from
exposure
to
diuron
from
food
exceeds
HED's
level
of
concern
(>
1.0x10
6)
for
the
US
population.
The
lifetime
cancer
risk
for
the
US
population
is
approximately
2x10
6
(
Table
4).
Table
3:
Chronic
Dietary
Risk
Estimates.
U.
S.
Environmental
Protection
Agency
Ver.
7.73
DEEM
Chronic
analysis
for
DIURON
(
1989
92
data)
Residue
file
name:
C:\
WINDOWS\
Desktop\
diuron.
RS7
Adjustment
factor
#
2
used.
Analysis
Date
08
09
2001/
14:
32:
37
Residue
file
dated:
08
09
2001/
14:
26:
07/
8
Reference
dose
(
RfD,
Chronic)
=
.003
mg/
kg
bw/
day
===============================================================================
Total
exposure
by
population
subgroup
Total
Exposure
Population
mg/
kg
Percent
of
Rfd
Subgroup
body
wt/
day
Asparagus
(
ppm)
0.26
2.8
U.
S.
Population
(
total)
0.000088
2.9%
3.4%
U.
S.
Population
(
spring
season)
0.000088
2.9%
3.9%
U.
S.
Population
(
summer
season)
0.000086
2.9%
3.1%
U.
S.
Population
(
autumn
season)
0.000091
3.0%
3.3%
U.
S.
Population
(
winter
season)
0.000087
2.9%
3.5%
Northeast
region
0.000074
2.5%
3.1%
Midwest
region
0.000074
2.5%
3.0%
Southern
region
0.000113
3.8%
4.2%
Western
region
0.000078
2.6%
3.1%
Hispanics
0.000094
3.1%
3.3%
Non
hispanic
whites
0.000080
2.7%
3.3%
Non
hispanic
blacks
0.000130
4.3%
4.5%
Non
hisp/
non
white/
non
black
0.000101
3.4%
4.7%
All
infants
(<
1
year)
0.000077
2.6%
2.6%
Nursing
infants
0.000054
1.8%
1.8%
Non
nursing
infants
0.000087
2.9%
2.9%
Children
1
6
yrs
0.000200
6.7%
6.7%
Children
7
12
yrs
0.000118
3.9%
4.0%
Females
13
19
(
not
preg
or
nursing)
0.000068
2.3%
2.3%
Females
20+
(
not
preg
or
nursing)
0.000073
2.4%
3.3%
9
Females
13
50
yrs
0.000069
2.3%
2.8%
Females
13+
(
preg/
not
nursing)
0.000087
2.9%
3.2%
Females
13+
(
nursing)
0.000084
2.8%
3.8%
Males
13
19
yrs
0.000098
3.3%
3.5%
Males
20+
yrs
0.000066
2.2%
2.8%
Seniors
55+
0.000083
2.8%
3.9%
Pacific
Region
0.000080
2.7%
3.2%
Table
4:
Cancer
Dietary
Risk
Estimates.
U.
S.
Environmental
Protection
Agency
Ver.
7.73
DEEM
Chronic
analysis
for
DIURON
(
1989
92
data)
Residue
file
name:
C:\
WINDOWS\
Desktop\
diuron.
RS7
Adjustment
factor
#
2
used.
Analysis
Date
08
09
2001/
14:
39:
27
Residue
file
dated:
08
09
2001/
14:
26:
07/
8
Q*
=
0.0191
===============================================================================
Total
exposure
by
population
subgroup
Total
Exposure
Population
mg/
kg
Lifetime
risk
Subgroup
body
wt/
day
(
Q*=
.0191)
U.
S.
Population
(
total)
0.000088
1.68E
06
U.
S.
Population
(
spring
season)
0.000088
1.67E
06
U.
S.
Population
(
summer
season)
0.000086
1.64E
06
U.
S.
Population
(
autumn
season)
0.000091
1.75E
06
U.
S.
Population
(
winter
season)
0.000087
1.67E
06
Northeast
region
0.000074
1.40E
06
Midwest
region
0.000074
1.41E
06
Southern
region
0.000113
2.15E
06
Western
region
0.000078
1.49E
06
Hispanics
0.000094
1.79E
06
Non
hispanic
whites
0.000080
1.53E
06
Non
hispanic
blacks
0.000130
2.49E
06
Non
hisp/
non
white/
non
black
0.000101
1.94E
06
10
All
infants
(<
1
year)
0.000077
1.48E
06
Nursing
infants
0.000054
1.03E
06
Non
nursing
infants
0.000087
1.66E
06
Children
1
6
yrs
0.000200
3.81E
06
Children
7
12
yrs
0.000118
2.25E
06
Females
13
19
(
not
preg
or
nursing)
0.000068
1.30E
06
Females
20+
(
not
preg
or
nursing)
0.000073
1.39E
06
Females
13
50
yrs
0.000069
1.32E
06
Females
13+
(
preg/
not
nursing)
0.000087
1.67E
06
Females
13+
(
nursing)
0.000084
1.60E
06
Males
13
19
yrs
0.000098
1.87E
06
Males
20+
yrs
0.000066
1.26E
06
Seniors
55+
0.000083
1.59E
06
Pacific
Region
0.000080
1.53E
06
Attachment
1.
DEEM
Residue
Input
File.
Filename:
C:\
WINDOWS\
Desktop\
diuron\
diuron.
RS7
Chemical:
diuron
RfD(
Chronic):
.003
mg/
kg
bw/
day
NOEL(
Chronic):
0
mg/
kg
bw/
day
RfD(
Acute):
0
mg/
kg
bw/
day
NOEL(
Acute):
0
mg/
kg
bw/
day
Date
created/
last
modified:
08
09
2001/
14:
26:
07/
8
Program
ver.
7.73
Food
Crop
Def
Res
Adj.
Factors
Code
Grp
Food
Name
(
ppm)
#
1
#
2
40
14
Almonds
0.100000
1.000
0.010
52
11
Apples
0.016000
1.000
0.130
53
11
Apples
dried
0.016000
8.000
0.130
54
11
Apples
juice/
cider
0.016000
1.300
0.130
377
11
Apples
juice
concentrate
0.016000
3.900
0.130
11
181
O
Artichokes
globe
0.300000
1.000
0.020
260
O
Asparagus
0.260000
1.000
0.530
72
O
Bananas
0.025000
1.000
0.140
73
O
Bananas
dried
0.025000
3.900
0.140
378
O
Bananas
juice
0.025000
1.000
0.140
265
15
Barley
0.100000
1.000
0.010
323
M
Beef
dried
0.000001
1.920
1.000
324
M
Beef
fat
w/
o
bones
0.000003
1.000
1.000
325
M
Beef
kidney
0.000026
1.000
1.000
327
M
Beef
lean
(
fat/
free)
w/
o
bones
0.000001
1.000
1.000
326
M
Beef
liver
0.000050
1.000
1.000
321
M
Beef
meat
byproducts
0.000050
1.000
1.000
322
M
Beef
other
organ
meats
0.000050
1.000
1.000
1
13A
Blackberries
0.100000
1.000
0.530
380
13A
Blackberries
juice
0.100000
1.000
0.530
7
13B
Blueberries
0.100000
1.000
0.290
2
13A
Boysenberries
0.100000
1.000
0.070
366
P
Chicken
byproducts
0.000170
1.000
1.000
368
P
Chicken
fat
w/
o
bones
0.000170
1.000
1.000
367
P
Chicken
giblets(
liver)
0.001500
1.000
1.000
385
P
Chicken
giblets
(
excl.
liver)
0.000170
1.000
1.000
369
P
Chicken
lean/
fat
free
w/
o
bones
0.000170
1.000
1.000
267
15
Corn
grain
bran
0.086000
1.000
0.010
266
15
Corn
grain
endosperm
0.086000
1.000
0.010
289
15
Corn
grain
oil
0.086000
1.000
0.010
268
15
Corn
grain/
sugar/
hfcs
0.086000
1.500
0.010
388
15
Corn
grain/
sugar
molasses
0.086000
1.500
0.010
237
15
Corn/
pop
0.086000
1.000
0.010
238
15
Corn/
sweet
0.066000
1.000
0.010
291
O
Cottonseed
meal
0.100000
1.000
0.110
290
O
Cottonseed
oil
0.020000
1.000
0.110
10
13B
Currants
0.100000
1.000
0.320
3
13A
Dewberries
0.100000
1.000
0.530
364
P
Eggs
white
only
0.000027
1.000
1.000
363
P
Eggs
whole
0.000260
1.000
1.000
365
P
Eggs
yolk
only
0.000690
1.000
1.000
44
14
Filberts
(
hazelnuts)
0.100000
1.000
0.140
352
F
Fish
finfish/
freshwater
2.000000
1.000
0.350
330
M
Goat
fat
w/
o
bone
0.000003
1.000
1.000
331
M
Goat
kidney
0.000026
1.000
1.000
333
M
Goat
lean
(
fat/
free)
w/
o
bone
0.000001
1.000
1.000
332
M
Goat
liver
0.000050
1.000
1.000
328
M
Goat
meat
byproducts
0.000050
1.000
1.000
329
M
Goat
other
organ
meats
0.000050
1.000
1.000
12
13B
Gooseberries
0.100000
1.000
0.320
12
23
10
Grapefruit
juice
0.012000
2.100
0.470
441
10
Grapefruit
juice
concentrate
0.012000
8.260
0.470
448
10
Grapefruit
peel
0.012000
1.000
0.470
22
10
Grapefruit
peeled
fruit
0.012000
1.000
0.470
13
O
Grapes
0.021000
1.000
0.100
15
O
Grapes
juice
0.021000
1.200
0.100
392
O
Grapes
juice
concentrate
0.021000
3.600
0.100
195
O
Grapes
leaves
0.021000
1.000
0.100
14
O
Grapes
raisins
0.021000
4.300
0.100
315
O
Grapes
wine
and
sherry
0.021000
1.000
0.100
334
M
Horsemeat
0.000001
1.000
1.000
16
13B
Huckleberries
0.100000
1.000
0.290
28
10
Lemons
juice
0.050000
2.000
0.260
442
10
Lemons
juice
concentrate
0.050000
11.400
0.260
27
10
Lemons
peel
0.050000
1.000
0.260
26
10
Lemons
peeled
fruit
0.050000
1.000
0.260
32
10
Limes
juice
0.050000
2.000
0.330
443
10
Limes
juice
concentrate
0.050000
6.000
0.330
31
10
Limes
peel
0.050000
1.000
0.330
30
10
Limes
peeled
fruit
0.050000
1.000
0.330
4
13A
Loganberries
0.100000
1.000
0.330
46
14
Macadamia
nuts
(
bush
nuts)
0.100000
1.000
0.050
398
D
Milk
based
water
0.000058
1.000
1.000
319
D
Milk
fat
solids
0.000058
1.000
1.000
318
D
Milk
nonfat
solids
0.000058
1.000
1.000
320
D
Milk
sugar
(
lactose)
0.000058
1.000
1.000
911
O
Molasses
nfs
0.088000
1.000
0.040
399
15
Oats
bran
0.300000
1.000
0.010
269
15
Oats
0.100000
1.000
0.010
82
O
Olives
1.000000
1.000
0.240
300
O
Olive
oil
1.000000
1.000
0.240
36
10
Oranges
juice
0.030000
1.800
0.510
33
10
Oranges
juice
concentrate
0.030000
6.700
0.510
35
10
Oranges
peel
0.030000
1.000
0.510
34
10
Oranges
peeled
fruit
0.030000
1.000
0.510
85
O
Papayas
dried
0.500000
1.800
0.130
86
O
Papayas
juice
0.500000
1.500
0.130
84
O
Papayas
pulp
0.500000
1.000
0.130
65
12
Peaches
0.100000
1.000
0.100
66
12
Peaches
dried
0.100000
7.000
0.100
402
12
Peaches
juice
0.100000
1.000
0.100
56
11
Pears
0.016000
1.000
0.090
57
11
Pears
dried
0.016000
6.250
0.090
404
11
Pears
juice
0.016000
1.000
0.090
240
6C
Peas
(
garden)
dry
1.000000
1.000
0.010
13
241
6AB
Peas
(
garden)
green
1.000000
1.000
0.010
405
6B
Peas
succulent/
blackeye/
cowpea
1.000000
1.000
1.000
47
14
Pecans
0.100000
1.000
0.030
310
O
Peppermint
1.500000
1.000
0.410
311
O
Peppermint
oil
1.500000
1.000
0.410
90
O
Pineapples
dried
0.100000
5.000
0.130
91
O
Pineapples
juice
0.070000
1.700
0.130
406
O
Pineapples
juice
concentrate
0.070000
6.300
0.130
89
O
Pineapples
peeled
fruit
0.100000
1.000
0.130
50
O
Pistachio
nuts
0.100000
1.000
0.050
344
M
Pork
fat
w/
o
bone
0.000003
1.000
1.000
345
M
Pork
kidney
0.000026
1.000
1.000
347
M
Pork
lean
(
fat
free)
w/
o
bone
0.000001
1.000
1.000
346
M
Pork
liver
0.000050
1.000
1.000
342
M
Pork
meat
byproducts
0.000050
1.000
1.000
343
M
Pork
other
organ
meats
0.000050
1.000
1.000
362
P
Poultry
other
fat
w/
o
bones
0.000170
1.000
1.000
361
P
Poultry
other
giblets(
liver)
0.001500
1.000
1.000
360
P
Poultry
other
lean
(
fat
free)
w/
0.000170
1.000
1.000
5
13A
Raspberries
0.100000
1.000
0.130
338
M
Sheep
fat
w/
o
bone
0.000003
1.000
1.000
339
M
Sheep
kidney
0.000026
1.000
1.000
341
M
Sheep
lean
(
fat
free)
w/
o
bone
0.000001
1.000
1.000
340
M
Sheep
liver
0.000050
1.000
1.000
336
M
Sheep
meat
byproducts
0.000050
1.000
1.000
337
M
Sheep
other
organ
meats
0.000050
1.000
1.000
275
15
Sorghum
(
including
milo)
0.134000
1.000
0.010
283
O
Sugar
cane
0.000180
1.000
0.040
284
O
Sugar
cane/
molasses
0.088000
1.000
0.040
37
10
Tangelos
0.050000
1.000
0.470
38
10
Tangerines
0.050000
1.000
0.300
39
10
Tangerines
juice
0.050000
2.300
0.300
420
10
Tangerines
juice
concentrate
0.050000
7.350
0.300
355
P
Turkey
byproducts
0.000170
1.000
1.000
357
P
Turkey
fat
w/
o
bones
0.000170
1.000
1.000
356
P
Turkey
giblets
(
liver)
0.001500
1.000
1.000
358
P
Turkey
lean/
fat
free
w/
o
bones
0.000170
1.000
1.000
449
P
Turkey
other
organ
meats
0.000170
1.000
1.000
431
14
Walnut
oil
0.100000
1.000
0.120
48
14
Walnuts
0.100000
1.000
0.120
278
15
Wheat
bran
0.300000
1.000
0.010
279
15
Wheat
flour
0.019000
1.000
0.010
277
15
Wheat
germ
0.300000
1.000
0.010
437
15
Wheat
germ
oil
0.300000
1.000
0.010
276
15
Wheat
rough
0.136000
1.000
0.010
14
cc:
JS
Punzi
(
RRB2),
Diuron
List
B
File,
Diuron
Subject
File,
RF,
LAN.
RD/
I:
RRB2
Chem
Team
Review
(
9/
12/
01),
Dietary
Exposure
SAC
(
9/
12/
01).
7509C:
RRB2:
J.
Punzi:
CM#
2:
Rm
712M:
703
305
7727.
| epa | 2024-06-07T20:31:43.612704 | regulations | {
"license": "Public Domain",
"url": "https://downloads.regulations.gov/EPA-HQ-OPP-2002-0249-0012/content.txt"
} |
EPA-HQ-OPP-2002-0249-0013 | Supporting & Related Material | "2002-10-01T04:00:00" | null | 1
UNITED
STATES
ENVIRONMENTAL
PROTECTION
AGENCY
WASHINGTON,
D.
C.
20460
HED
DOC.
NO.
014596
OFFICE
OF
PREVENTION,
PESTICIDES
AND
TOXIC
SUBSTANCES
DATE:
June
20,
2001
MEMORANDUM
SUBJECT:
DIURON:
Report
of
the
Hazard
Identification
Assessment
Review
Committee
FROM:
Yung
G.
Yang,
Ph.
D.
Toxicology
Branch
Health
Effects
Division
(
7509C)
THROUGH:
Jess
Rowland,
Co
Chair
and
Elizabeth
Doyle,
Co
Chair
Hazard
Identification
Assessment
Review
Committee
Health
Effects
Division
(
7509C)
TO:
Diana
Locke,
Ph.
D.
Risk
Assessor,
RRB2
Health
Effects
Division
(
7509C)
PC
CODE:
035505
On
May
29,
2001,
the
Health
Effects
Division
(
HED)
Hazard
Identification
Assessment
Review
Committee
(
HIARC)
convened
to
review
the
toxicology
data
base
of
diuron
for
hazard
identification
and
to
select
doses
and
endpoints
for
acute
dietary,
chronic
dietary
(
RfD)
as
well
as
occupational
and
residential
exposure
assessments
and
to
address
the
sensitivity
of
infants
and
children
from
exposure
to
diuron
as
required
by
the
Food
Quality
Protection
Act
(
FQPA)
of
1996.
The
HIARC's
conclusions
are
presented
in
this
report.
2
Committee
Members
in
Attendance
Members
in
attendance:
Ayaad
Assaad,
Jonathan
Chen,
Pamela
Hurley,
Jess
Rowland
(
Chair),
David
Nixon,
Brenda
Tarplee,
and
Yung
Yang.
Members
in
absentia:
William
Burnam,
Elizabeth
Doyle,
and
Elizabeth
Mendez.
Also,
in
attendance:
Paula
Deschamp,
Diana
Locke,
Alberto
Protzel,
John
Punzi,
Renee
Sandvig,
and
Ibrahim
Abdel
Saheb
(
EFED)
Data
evaluation
/
presentation:
Yung
G.
Yang
Toxicology
Branch.
Diuron
3
INTRODUCTION
Diuron
is
a
substituted
urea
herbicide
for
the
control
of
a
wide
variety
of
annual
and
perennial
broadleaves
and
grassy
weeds
on
both
crop
and
noncrop
sites.
Its
main
use
is
as
a
pre
emergent,
soil
applied
herbicide,
but
it
can
also
be
used
to
control
emerged
weeds.
Diuron
is
available
as
a
technical
material,
at
95
98%
active
ingredient
or
as
a
manufacturing
use
product
containing
80%
diuron
for
formulation
of
diuron
end
use
formulations
or
as
manufacturing
use
products.
As
a
sole
active
ingredient,
diuron
is
available
in
wettable
powder,
granular,
flowables,
pelleted/
tableted,
liquid
suspensions,
and
soluble
concentrate
formulations.
The
exposure
duration
is
expected
to
be
short
term
for
residential
uses
and
short
and
intermediate
term
for
occupational
uses.
Empirical
formula:
C9H10Cl
2N2O
Molecular
weight:
233.1
CAS
Registry
No.:
330
54
1
PC
Code:
035505
NH
N
CH
3
CH3
O
Cl
Cl
The
toxicology
data
base
of
diuron
has
been
evaluated
by
the
Health
Effects
Division
RfD
Review
Committee
on
September
26,
1996
and
the
Carcinogenicity
Peer
Review
Committee
on
December
12,
1996.
A
Section
18
exemption
for
the
use
of
diuron
80W
in
catfish
ponds
in
Mississippi
has
been
issued
on
May
13,
1999
after
brief
reviews
by
the
HIARC
on
March
18,
1999
and
FQPA
Safety
Factor
Committee
on
March
22,
1999.
Since
then,
the
toxicology
data
base
of
diuron
has
been
rereviewed
and
updated
by
the
Toxicology
Branch
for
a
Reregistration
Eligibility
Decision
(
RED).
On
May
29,
2001
the
HIARC
reviewed
the
toxicology
data
base
of
diuron
for
hazard
identification
and
to
select
doses
and
endpoints
for
acute
dietary,
chronic
dietary
(
RfD)
as
well
as
occupational
and
residential
exposure
assessments
in
support
of
a
RED
and
to
address
the
sensitivity
of
infants
and
children
from
exposure
to
diuron
as
required
by
the
Food
Quality
Protection
Act
(
FQPA)
of
1996.
The
HIARC's
conclusions
are
as
follows.
Diuron
4
Acute
RfD
=
N/
A
1.
HAZARD
IDENTIFICATION
1.1
Acute
Reference
Dose
(
RfD)
Study
Selected:
None
MRID
No.:
N/
A
Executive
Summary:
N/
A
Dose
and
Endpoint
for
Establishing
RfD:
N/
A
Uncertainty
Factor
(
UF):
N/
A
Comments
about
Study/
Endpoint/
Uncertainty
Factor:
No
appropriate
effects
attributed
to
a
single
exposure
(
dose)
was
identified
including
in
the
rat
or
rabbit
developmental
toxicity
study.
It
should
be
noted
that
at
the
5/
13/
99
HIARC
meeting
for
Section
18
Exemption,
a
NOAEL
of
16
mg/
kg/
day
from
a
rat
developmental
study
with
an
uncertainty
factor
of
100
was
selected
for
the
acute
reference
dose
based
on
decreased
maternal
body
weight
(
beginning
at
gestation
day
9)
and
food
consumption
(
during
gestation
day
6
10)
at
80
mg/
kg/
day
(
LOAEL).
This
dose/
endpoint
was
selected
to
provide
a
conservative
risk
assessment
for
that
action.
However,
at
this
meeting
(
5/
29/
01)
the
HIARC
determined
that
it
is
unlikely
that
one
dose
will
cause
body
weight
decrease.
In
addition,
there
was
no
developmental
or
neurotoxic
concern
for
diuron;
therefore,
no
hazard
was
identified
and
quantitative
risk
assessment
is
not
required.
1.2
Chronic
Reference
Dose
(
RfD)
Study
Selected:
Chronic
toxicity/
carcinogenicity
study
rats
Guideline
#:
870.4300
MRID
No.:
40886501,
43871901,43804501,44302003
Executive
Summary:
In
a
chronic
toxicity/
oncogenicity
study
(
MRID
40886501;
supplementary
data
provided
in
MRIDs
43871901,
43804501,
and
44302003),
diuron
(
98.7%
a.
i.;
batch
no.
232114080)
was
administered
to
groups
of
60
male
and
60
female
Wistar
rats
at
dietary
concentrations
of
0,
25,
250,
or
2500
ppm
(
0,
1.0,
10,
or
111
mg/
kg/
day,
respectively,
for
males
Diuron
5
and
0,
1.7,
17,
or
202
mg/
kg/
day
for
females,
respectively)
for
up
to
24
months.
At
12
months,
10
animals/
sex/
group
were
sacrificed
for
interim
evaluation.
Treatment
with
diuron
did
not
affect
the
survival
of
rats.
The
only
reported
treatment
related
clinical
sign
was
reddish
discolored
or
bloody
urine
in
high
dose
males.
A
significant
decrease
in
body
weight
was
seen
in
both
sexes
of
high
dose
rats
(
12
15%
for
males;
6
14%
for
females,
p<
0.01)
throughout
the
study.
Body
weight
gains
were
similarly
depressed,
the
total
gains
for
high
dose
males
and
females
were
82
and
79%
of
controls,
respectively.
The
slight
decreases
in
body
weights
and
weight
gains
of
mid
dose
males
(
4
6%;
p<
0.05
or
0.01)
were
not
biologically
significant.
Food
consumption
was
unaffected
but
overall
food
efficiency
was
lowered
for
high
dose
males
and
females
(
86%
and
76%
of
controls,
respectively).
Diuron
affected
hematopoietic
system
resulting
in
hemolytic
anemia
and
compensatory
hematopoiesis,
which
were
manifested
as
significantly
decreased
(
p<
0.05
or
0.01)
erythrocyte
counts,
hemoglobin
levels,
and
hematocrit
and
increased
MCV,
MCH,
abnormal
erythrocyte
forms,
reticulocyte
counts,
and
leukocyte
counts
(
with
no
effect
on
differential
counts)
in
midand
or
high
dose
males
and
females,
and
in
low
dose
females
(
#
25%
change
for
most
parameters;
3
fold
increase
for
reticulocytes).
Hemolysis
also
led
to
increased
(
39
50%)
plasma
bilirubin
in
high
dose
males
and
females.
Consistent
with
erythrocyte
damage,
postmortem
gross
examination
showed
a
dose
related
increase
(
18
220%)
in
spleen
weight
(
absolute
and
relative
to
body)
for
all
test
groups
at
12
and/
or
24
months,
and
an
increased
incidence
of
spleen
dark
discoloration
and/
or
swelling
in
mid
and
high
dose
males
and
females
after
12
and/
or
24
months.
Morphometric
analysis
of
spleen
sections
to
determine
the
percentage
area
of
hemosiderin
revealed
an
increase
at
$
250
ppm
in
both
sexes
at
12
months
and
in
all
groups
at
24
months
(
p<
0.05
or
0.01),
with
the
females
being
affected
more
severely.
The
chronic
overburden
of
spleen
function
led
to
an
increased
incidence
of
spleen
fibrosis
in
2500
ppm
males
and
females
(
p<
0.01).
Bone
marrow
activation
occurred
in
both
sexes
at
all
test
doses
at
24
months
(
p<
0.05
or
0.01
for
all
but
low
dose
females).
This
was
evident
morphometrically
as
an
increase
in
hematopoietic
(
red)
bone
marrow
for
mid
and
high
dose
rats
at
12
and/
or
24
months
(
possibly
in
low
dose
males
at
12
months)
with
a
concomitant
decrease
in
fat
marrow
at
12
months
(
not
evaluated
at
24
months).
Gross
pathology
showed
that
the
incidence
of
urinary
bladder
wall
thickening
was
elevated
at
24
months
for
low
and
high
dose
males
and
high
dose
females
(
p<
0.05
or
0.01).
Microscopic
evaluation
showed
that
epithelial
focal
hyperplasia
of
the
urinary
tract
and
renal
pelvis
increased
in
severity
in
both
sexes
at
12
and/
or
24
months,
and
increased
in
incidence
(
p<
0.01)
in
high
dose
males
at
12
months
and
in
mid
and
high
dose
females
at
12
and/
or
24
months.
Some
gross
and/
or
microscopic
changes
were
also
seen
in
the
liver
(
increased
weight,
swelling,
discoloration,
vacuolar
cell
degeneration,
round
cell
infiltration,
hyperemia)
although
Diuron
6
Chronic
RfD
=
1.0
(
LOAEL)
mg/
kg/
day
=
0.003
mg/
kg/
day
300
(
UF)
these
effects
were
not
clearly
primary
effects
of
treatment.
Based
on
evidence
of
hemolytic
anemia
and
compensatory
hematopoiesis
(
decreased
erythrocyte
count,
increased
reticulocyte
counts,
increased
spleen
weight
and
bone
marrow
activation),
the
LOAEL
is
25
ppm
for
both
sexes
of
rats
(
1.0
and
1.7
mg/
kg/
day
for
males
and
females,
respectively).
A
NOAEL
was
not
established.
This
chronic
toxicity
/
carcinogenicity
study
in
rats
is
classified
as
Acceptable/
Guideline.
Dose
and
Endpoint
for
Establishing
RfD:
1.0
mg/
kg/
day
(
LOAEL)
based
on
evidence
of
hemolytic
anemia
and
compensatory
hematopoiesis
(
decreased
erythrocyte
count,
increased
reticulocyte
counts,
increased
spleen
weight
and
bone
marrow
activation).
A
NOAEL
was
not
established.
Uncertainty
Factor(
s):
300
Comments
about
Study/
Endpoint/
Uncertainty
Factor:
An
uncertainty
factor
(
UF)
of
100
is
applied
to
account
for
both
interspecies
extrapolation
and
intra
species
variability.
An
additional
UF
of
3
is
applied
for
the
use
of
a
LOAEL.
1.3
Occupational/
Residential
Exposure
1.3.1
Short
Term
(
1
7
days)
Incidental
Oral
Exposure
Study
Selected:
Developmental
toxicity
study
rabbits
§
870.3700
MRID
No.:
40228802
Executive
Summary:
In
a
developmental
toxicity
study
(
MRID
40228802),
24
25
artificially
inseminated
New
Zealand
white
rabbits
per
group
were
administered
0,
2,
10,
or
50
mg/
kg/
day
of
Diuron
(
99%
a.
i.;
Lot
No.
not
given)
by
gavage
on
gestation
days
(
GD)
7
19,
inclusive.
On
GD
29,
all
surviving
does
were
sacrificed
and
examined
Diuron
7
grossly.
One
control
animal
died
on
GD
0
due
to
an
anaphylactic
shock
reaction
during
insemination
and
one
high
dose
doe
aborted
and
was
killed
on
GD
26.
These
deaths
were
considered
unrelated
to
treatment.
All
remaining
animals
survived
to
scheduled
termination.
No
treatment
related
clinical
signs
of
toxicity
were
observed
in
any
animal.
Maternal
liver
weights
were
comparable
between
the
treated
and
control
groups
and
gross
necropsy
was
unremarkable.
Maternal
body
weights,
body
weight
gains,
and
food
consumption
for
the
low
and
mid
dose
groups
were
similar
to
the
control
levels
throughout
the
study.
Absolute
body
weights
of
the
high
dose
does
were
significantly
(
p
#
0.01)
less
than
the
controls
on
GD
20.
Mean
body
weight
gains
by
the
high
dose
group
were
significantly
(
p
#
0.05
or
0.01)
reduced
as
compared
with
the
controls
during
the
intervals
of
GD
10
13,
13
16,
and
7
20
(
weight
loss).
Weight
gain
by
the
high
dose
group
was
significantly
(
p
#
0.05
or
0.01)
greater
than
the
controls
during
the
post
dosing
interval.
Food
consumption
by
the
high
dose
group
was
significantly
(
p
#
0.01)
less
than
the
controls
during
the
GD
13
16,
16
20
and
7
20
intervals.
The
maternal
toxicity
LOAEL
is
established
at
50
mg/
kg/
day
based
on
decreased
body
weights
and
food
consumption
during
the
dosing
interval.
The
maternal
toxicity
NOAEL
is
established
at
10
mg/
kg/
day.
At
cesarean
section,
the
pregnancy
rates,
numbers
of
corpora
lutea,
implantation
sites,
resorptions,
and
live
fetuses,
and
fetal
body
weights
were
similar
between
the
treated
and
control
groups.
No
dose
or
treatment
related
external,
visceral,
or
skeletal
malformations/
variations
were
observed
in
any
fetus.
The
developmental
toxicity
NOAEL
is
$
50
mg/
kg/
day
and
the
developmental
toxicity
LOAEL
is
not
identified.
This
study
is
classified
as
Acceptable
and
satisfy
the
guideline
requirements
for
a
developmental
toxicity
study
[
OPPTS
870.3700
(
83
3b)]
in
rabbits.
Dose
and
Endpoint
for
Risk
Assessment:
10
mg/
kg/
day
(
NOAEL)
based
on
maternal
toxicity
(
decreased
body
weights
and
food
consumption
during
the
dosing
interval)
at
50
mg/
kg/
day
(
LOAEL).
Comments
about
Study/
Endpoint:
This
study
was
previously
classified
as
Diuron
8
unacceptable/
upgradable
based
on
deficiencies
in
analytical
data
of
sample
analysis.
However,
the
HIARC
determined
that
this
study
is
acceptable
because
the
low
nominal
level
of
sample
concentration
was
observed
at
the
low
dose
only
and
the
NOAEL
was
established
at
the
mid
dose
with
the
LOAEL
at
the
high
dose.
Therefore,
the
deficiencies
in
the
analytical
data
did
not
affect
the
results
of
the
study.
The
systemic
toxicity
(
expressed
as
maternal
toxicity)
is
relevant
for
the
populations
(
infants
and
children)
and
duration
(
1
7
days)
of
concern.
1.3.2
Intermediate
Term
(
7
Days
to
Several
Months)
Incidental
Oral
Exposure
Study
Selected:
Chronic
toxicity/
carcinogenicity
study
rats
§
MRID
No.:
40886501,
43871901,
43804501,
44302003
Executive
Summary:
See
Chronic
RfD.
Dose
and
Endpoint
for
Risk
Assessment:
A
NOAEL
of
1.0
mg/
kg/
day
based
on
hematological
effects
observed
at
10
mg/
kg/
day
(
LOAEL)
at
the
6th
month
observations.
Comments
about
Study/
Endpoint:
The
HIARC
established
a
NOAEL
of
1.0
mg/
kg/
day
for
this
time
period
based
on
hematological
effects
observed
at
10
mg/
kg/
day
at
the
6th
month
observation.
It
is
noted
that
this
NOAEL/
LOAEL
is
different
from
the
24th
month
observation
where
the
NOAEL
is
not
established
(
LOAEL=
1.0
mg/
kg/
day).
The
endpoint
observed
at
the
6th
month
observation
period
is
appropriate
for
this
exposure
scenario
and
is
relevant
for
the
population
of
concern.
1.3.3
Dermal
Absorption
No
dermal
absorption
study
is
available.
Dermal
Absorption
Factor:
An
upper
bound
estimation
of
dermal
absorption
factor
of
4%
is
extrapolated
using
the
maternal
LOAEL
of
50
mg/
kg/
day
from
the
developmental
study
in
the
rabbit
and
the
NOAEL
of
1200
mg/
kg/
day
(
HDT)
from
the
21
day
dermal
toxicity
study
in
the
rabbit:
the
ratio
is
50/
1200
or
4%.
1.3.4
Short
Term
Dermal
(
1
7
days)
Exposure
Diuron
9
Study
Selected:
None
MRID
No.:
N/
A
Executive
Summary:
N/
A
Dose
and
Endpoint
for
Risk
Assessment:
N/
A
Comments
about
Study/
Endpoint:.
No
systemic
toxicity
following
repeated
dermal
dosing
at
1200
mg/
kg/
day
was
seen
in
the
rabbit
dermal
toxicity
study.
Also,
there
is
no
developmental
concern.
No
hazard
was
identified
and
no
quantitative
assessment
is
required.
1.3.5
Intermediate
Term
Dermal
(
7
Days
to
Several
Months)
Exposure
Study
Selected:
None
MRID
No.:
N/
A
Executive
Summary:
N/
A
Dose/
Endpoint
for
Risk
Assessment:
N/
A
Comments
about
Study/
Endpoint:
No
systemic
toxicity
following
repeated
dermal
dosing
at
1200
mg/
kg/
day
was
seen
in
the
rabbit
dermal
toxicity
study.
Also,
there
is
no
developmental
concern.
No
hazard
was
identified
and
no
quantitative
assessment
is
required.
1.3.6
Long
Term
Dermal
(
Several
Months
to
Life
Time)
Exposure
Study
Selected:
Chronic
toxicity/
carcinogenicity
study
rats
MRID
No.:
40886501,
43871901,
43804501,
44302003
Executive
Summary:
See
chronic
RfD.
Dose
and
Endpoint
for
Risk
Assessment:
1.0
mg/
kg/
day
(
LOAEL)
based
on
evidence
of
hemolytic
anemia
and
compensatory
hematopoiesis
(
decreased
erythrocyte
count,
Diuron
10
increased
reticulocyte
counts,
increased
spleen
weight
and
bone
marrow
activation).
A
NOAEL
was
not
established.
Comments
about
Study/
Endpoint:
An
additional
UF
of
3
is
applied
to
account
for
the
lack
of
a
NOAEL
in
this
study.
A
MOE
of
300
is
required
for
this
risk
assessment
with
a
dermal
absorption
factor
of
4%.
1.3.7
Inhalation
Exposure
Except
for
an
acute
inhalation
study,
for
which
diuron
was
placed
in
Toxicity
Category
IV
(
LC
50>
7.1
mg/
L),
no
other
studies
are
available
via
this
route.
Therefore,
the
HIARC
selected
the
NOAELs
from
oral
studies
for
risk
assessment.
Since
the
doses
identified
for
inhalation
risk
assessment
are
from
oral
studies,
route
to
route
extrapolation
should
be
as
follows:
The
inhalation
exposure
component
(
i.
e.,
F
g
a.
i./
day)
using
a
100%
(
default)
absorption
rate
and
application
rate
should
be
converted
to
an
equivalent
oral
dose
(
mg/
kg/
day).
Then,
the
oral
equivalent
doses
should
be
compared
to
the
following
NOAELs/
LOAEL
to
calculate
the
MOEs.
Short
term
NOAEL=
10
mg/
kg/
day
(
developmental
rabbit
study)
Intermediated
term
NOAEL=
1.0
mg/
kg/
day
(
chronic
rat
study
at
6
month)
Long
term
LOAEL=
1.0
mg/
kg/
day
(
chronic
rat
study)
1.3.8
Margins
of
Exposure
for
Occupational/
Residential
Risk
Assessments
A
MOE
of
100
is
adequate
for
short
and
intermediate
term
occupational
inhalation
exposure.
However,
a
MOE
of
300
is
required
for
long
term
occupational
dermal
and
inhalation
exposure
due
to
the
use
of
LOAEL.
The
acceptable
MOEs
for
residential
exposure
will
be
determined
by
the
FQPA
SF
committee.
1.4
Recommendation
for
Aggregate
Exposure
Risk
Assessments
A
toxicological
endpoint
was
not
identified
for
acute
dietary
risk
assessment;
therefore,
the
acute
aggregate
is
not
required.
A
common
toxicological
endpoint
(
decreased
body
weight
and
food
consumption)
was
Diuron
11
selected
for
assessment
of
short
term
exposure
by
oral
and
inhalation
routes.
These
routes
can
be
aggregated
for
this
scenario.
A
common
toxicological
endpoint
(
altered
hematological
parameters)
was
selected
for
intermediated
term
exposure
by
oral
and
inhalation
routes.
These
routes
can
be
aggregated
for
this
scenario.
A
common
toxicological
endpoint
(
evidence
of
hemolytic
anemia
and
compensatory
hematopoiesis)
was
selected
for
long
term
exposure
by
oral,
dermal,
and
inhalation
routes.
These
routes
can
be
aggregated
for
this
scenario.
2
CLASSIFICATION
OF
CARCINOGENIC
POTENTIAL
2.1
Combined
Chronic
Toxicity/
Carcinogenicity
Study
in
Rats
MRID
No.
40886501,
43871901,
43804501,
44302003
Discussion
of
Tumor
Data:
This
study
showed
conclusive
evidence
for
the
carcinogenicity
of
diuron
in
male
and
female
rats.
The
incidence
of
urinary
bladder
carcinoma
was
increased
at
2500
ppm
in
both
sexes
(
males:
33/
49
vs.
1/
50
for
controls;
females:
11/
50
vs.
0/
48
for
controls;
p<
0.01).
The
malignancies
were
usually
characterized
as
transitional
epithelial
carcinomas.
The
slight
increase
(
NS)
in
the
incidence
of
urinary
bladder
papilloma
and
the
3
neoplasms
in
the
renal
pelvis
in
high
dose
males
(
one
papilloma
and
two
carcinomas)
were
also
considered
treatment
related.
Adequacy
of
the
Dose
Levels
Tested:
Dosing
was
adequate
based
on
numerous
toxic
effects
(
hematological,
microscopic,
etc.)
observed
in
the
animals
at
all
tested
doses.
2.2
Carcinogenicity
Study
in
Mice
MRID
No.
:
42159501,
43349301
Discussion
of
Tumor
Data:
Treatment
of
up
to
102
weeks
with
2500
ppm
diuron
resulted
in
a
significant
increase
in
the
incidences
of
mammary
adenocarcinomas
(
control,
4%;
2500
ppm,
12%,
p
#
0.05)
and
ovarian
luteomas
(
control,
6%;
2500
ppm,
14%,
p
#
0.01)
in
female
NMRI
(
SPF
HAN)
mice
under
the
conditions
of
this
study.
However,
the
incidence
of
mammary
adenocarcinoma
in
high
dose
females
was
at
or
near
the
high
range
of
incidences
seen
in
historic
controls.
Diuron
12
Adequacy
of
the
Dose
Levels
Tested:
Dosing
was
adequate
based
on
observations
at
the
highest
dose
tested
including
decreased
body
weight
of
both
sexes,
increased
spleen
and
liver
weights
in
males
and
increased
incidence
of
urinary
bladder
edema
and
epithelial
hyperplasia,
thickened
mucosa
and
enlarged
uterine
horn
in
females.
2.3
Classification
of
Carcinogenic
Potential
The
HED
Carcinogenicity
Peer
Review
Committee
(
CPRC)
met
on
December
18,
1996
and
classified
diuron
as
a
"
known/
likely"
human
carcinogen
by
all
routes,
based
on
urinary
bladder
carcinoma
in
both
sexes
of
the
Wistar
rat,
kidney
carcinomas
in
the
male
rat
(
a
rare
tumor),
and
mammary
gland
carcinomas
in
the
female
NMRI
mouse.
The
CPRC
also
recommended
a
low
dose
linear
extrapolation
model
with
Q1
*
(
mg/
kg/
day)
1
of
1.91x10
2
be
applied
to
the
animal
data
for
the
quantification
of
human
risk,
based
on
the
urinary
bladder
carcinomas
in
the
rat.
The
HIARC
acknowledged
that
this
classification
may
be
re
evaluated
by
the
CARC
pending
Registrant's
submissions
of
mechanistic
study
for
cancer.
3
MUTAGENICITY
Five
acceptable
genetic
toxicology
studies
with
Diuron
have
been
submitted
to
the
Agency.
Findings
from
these
studies
indicated
the
following:
GENE
MUTATIONS
1)
Salmonella
typhimurium
reverse
gene
mutation
assay
(
MRID
No.
00146608/
40228805):
Independent
trials
were
negative
in
S.
typhimurium
strains
TA1535,
TA97,
TA98
and
TA100
up
to
the
highest
does
tested
(
10
µ
g/
plate
S9;
250
µ
g/
plate
+
S9);
higher
concentrations
(
$
50
µ
g/
plate
S9;
500
µ
g/
plate
+
S9)
were
cytotoxic.
The
assay
is
Acceptable
and
satisfies
the
guideline
requirement
for
gene
mutation
in
microbial
test
systems.
2)
Chinese
Hamster
Ovary
(
CHO)/
HGPRT
cell
forward
gene
mutation
assay
(
MRID
No.
00146609):
Independent
tests
were
negative
up
to
cytotoxic
doses
without
S9
activation
(
1.250
mM,
.
291
µ
g/
mL)
and
with
S9
activation
(
0.5
mM
,
.
117
µ
g/
mL).
The
assay
is
Acceptable
and
satisfies
the
guideline
requirement
for
gene
mutation
in
cultured
mammalian
cells.
CHROMOSOME
ABERRATIONS
Diuron
13
3)
In
vivo
bone
marrow
cytogenetic
assay
(
MRID
No.
00146611):
The
test
was
weakly
positive
in
male
Sprague
Dawley
rats
administered
0,
50,
500
or
5000
mg/
kg/
day
by
single
oral
gavage.
Signs
of
overt
toxicity
(
mortality,
body
weight
loss,
ocular
discharge,
depression,
labored
respiration,
diarrhea,
and
tremors)
and
cytotoxicity
to
the
target
organ
(
significantly
decreased
mitotic
index)
were
seen
at
5000
mg/
kg
in
conjunction
with
a
significant
(
p<
0.05)
increase
in
the
percentage
of
abnormal
cells
when
the
data
for
both
sexes
were
combined
(
0.11
versus
0.00
in
controls).
A
significant
positive
linear
trend
(
p<
0.01)
was
also
recorded
for
the
percentage
abnormal
cells
combined.
A
total
of
4/
10
animals
in
the
high
dose
group
were
affected:
single
chromatid
breaks
were
seen
in
two
males
and
one
female
and
a
chromatid
fragment
was
seen
in
one
male.
This
study
is
classified
as
Acceptable
and
satisfies
the
guideline
requirement
for
in
vivo
cytogenetic
mutagenicity
data.
4)
In
vivo
bone
marrow
cytogenetic
assay
(
MRID
No.
44350301):
The
test
was
negative
in
male
Sprague
Dawley
rats
administered
0,
50,
500
or
5000
mg/
kg/
day
by
single
oral
gavage.
Signs
of
overt
toxicity
(
mortality,
body
weight
loss,
ocular
discharge,
depression,
labored
respiration,
diarrhea,
and
tremors)
were
noted
at
5000
mg/
kg.
Cytotoxicity
to
the
target
organ
as
indicated
by
the
significantly
decreased
(
p
#
0.01)
mitotic
indices
at
24
and
48
hours
for
high
dose
males;
data
combined
for
both
sexes
were
also
significantly
decreased
at
24
hours.
A
significant
(
p<
0.05)
increase
in
the
percentage
of
abnormal
cells
and
the
average
number
of
aberrations
per
cell
was
seen
but
only
when
the
data
were
combined
for
the
high
and
mid
dose
males
and
females
at
the
48
hour
sampling
time.
Values
were
0.6
and
0.9
%
(
combined
percentage
abnormal
cells)
at
500
and
5000
mg/
kg,
respectively
and
0.008
and
0.009
(
combined
number
of
aberrations/
cell)
at
500
and
5000
mg/
kg,
respectively.
A
significant
positive
linear
trend
was
also
recorded
for
the
combined
(
by
sex)
aberrations
per
cell
and
percentage
abnormal
cells.
Nevertheless,
the
values
fell
well
within
the
range
of
historical
control
[
percent
abnormal
cells/
group:
0
2.6%
(
%
)
and
0
2.0%
(
&
)
;
average
number
of
aberrations/
cell:
0
0.023%
(
%
)
and
0
0.060
%
(
&
)
].
This
study
is
classified
as
Acceptable
and
satisfies
the
guideline
requirement
for
in
vivo
cytogenetic
mutagenicity
data.
OTHER
MUTAGENIC
MECHANISMS
4)
Unscheduled
DNA
synthesis
(
UDS)
in
primary
rat
hepatocytes
assay
(
MRID
No.
00146610):
The
test
was
negative
up
to
cytotoxic
doses
(
$
0.33
mM,
equivalent
to
.
76
F
g/
mL).
The
assay
is
Acceptable
and
satisfies
the
guideline
requirement
for
a
UDS
assay.
Conclusions:
Diuron
was
not
mutagenic
in
bacteria
or
in
cultured
mammalian
cells
and
no
indication
of
DNA
damage
in
primary
rat
hepatocytes
was
observed.
There
was
weak
evidence
of
an
in
vivo
clastogenic
response
in
Sprague
Dawley
rats
in
one
study
and
statistically
significant
increases
in
cells
with
structural
aberrations
in
a
second
study
conducted
with
the
same
rat
strain.
The
data
from
the
latter
study,
however,
were
shown
to
fall
within
the
historical
control
range.
Diuron
14
4
FQPA
CONSIDERATIONS
4.1
Adequacy
of
the
Data
Base
The
data
base
is
adequate
for
FQPA
assessment.
Acute
delayed
neurotoxicity
study
in
hen:
Not
required.
Acute
and
subchronic
neurotoxicity
studies:
Not
available.
Developmental
toxicity
studies
in
Rats:
Study
was
Unacceptable.
Developmental
toxicity
studies
in
Rabbits:
Acceptable
study
available.
Two
Generation
Reproduction
Study
in
rats:
Acceptable
study
available.
Developmental
neurotoxicity
study:
Not
available.
4.2
Neurotoxicity
No
acute
or
subchronic
neurotoxicity
study
is
available.
There
are
no
neurotoxic
signs
in
any
of
the
subchronic
or
chronic
studies.
Literature
search
did
not
reveal
studies
relevant
for
assessing
the
potential
neurotoxicity.
4.3
Developmental
Toxicity
Developmental
toxicity
study
in
rabbits
See
short
term
incidental
oral
exposure.
Developmental
toxicity
study
in
rats
In
a
developmental
toxicity
study
(
MRID
40228801),
25
presumed
pregnant
Crl:
COBS
®
CD
®
(
SD)
BR
rats
per
group
were
administered
H
16035
(
99%;
Lot
No.
not
given)
by
gavage
in
0.5%
aqueous
hydroxypropyl
methylcellulose
at
doses
of
0,
16,
80,
or
400
mg/
kg/
day
on
gestation
days
(
GD)
6
15,
inclusive.
On
GD
20,
dams
were
sacrificed,
subjected
to
gross
necropsy,
and
all
fetuses
were
examined
externally.
Approximately
one
half
of
all
fetuses
were
examined
viscerally
by
the
Staples
technique;
these
fetuses
were
decapitated,
and
the
heads
fixed
in
Bouin's
solution
for
subsequent
free
hand
sectioning.
The
remaining
one
half
of
the
fetuses
were
eviscerated
and
all
carcasses
were
processed
for
Diuron
15
skeletal
examination.
All
dams
survived
to
terminal
sacrifice.
One
high
dose
animal
appeared
thin
on
GD
13
18
as
a
result
of
marked
weight
loss.
No
other
treatment
related
clinical
signs
of
toxicity
were
observed
in
any
group.
Body
weights,
body
weight
gains,
and
food
consumption
by
the
lowdose
group
were
similar
to
the
controls
throughout
the
study.
No
treatment
related
lesions
were
observed
in
any
dam
at
necropsy.
Absolute
body
weights
of
the
mid
and
high
dose
groups
were
significantly
(
p
#
0.01)
less
than
the
controls
during
the
dosing
interval
and
ranged
from
92
94%
and
84
88%,
respectively,
of
the
control
levels.
Body
weight
gains
by
the
mid
and
high
dose
dams
were
significantly
(
p
#
0.05
or
0.01)
less
than
that
of
the
controls
during
the
dosing
period
with
the
exception
of
GD
12
16.
The
most
pronounced
effect
on
body
weight
gain
occurred
immediately
after
the
initiation
of
dosing
(
GD
6
9)
when
the
mid
and
high
dose
groups
had
a
net
weight
loss
compared
to
a
gain
by
the
controls.
The
high
dose
group
also
had
a
weight
loss
for
GD
9
12.
Weight
change
during
the
entire
dosing
interval
was
37%
of
the
control
level
for
the
mid
dose
group
and
a
weight
loss
of
12.2
g
by
the
high
dose
group.
Food
consumption
by
the
mid
and
high
dose
groups
was
significantly
(
73
and
47%,
respectively,
of
controls;
p
#
0.01)
less
than
the
controls
during
the
dosing
interval.
Weight
gain
and
food
consumption
by
the
mid
and
high
dose
dams
during
the
post
dosing
period
was
significantly
(
p
#
0.01)
greater
than
the
controls.
The
maternal
toxicity
LOAEL
is
established
at
80
mg/
kg/
day
based
on
decreased
body
weights,
body
weight
gains,
and
food
consumption.
The
maternal
toxicity
NOAEL
is
16
mg/
kg/
day.
No
differences
were
observed
between
the
treated
and
control
groups
for
pregnancy
rate,
number
of
corpora
lutea,
number
of
implantation
sites,
number
of
fetuses/
litter,
or
fetal
sex
ratios.
No
dead
fetuses
or
late
resorptions
were
observed.
Two
high
dose
dams
had
total
litter
resorption
and
the
number
of
early
resorptions/
dam
in
the
high
dose
group
(
3.2)
was
slightly
greater
than
that
of
the
controls
(
1.2).
Mean
fetal
body
weight
in
the
high
dose
group
was
significantly
(
p
#
0.01;
91%
of
controls)
less
than
that
of
the
controls.
In
the
0,
16,
80,
and
400
mg/
kg/
day
groups,
the
total
number
of
fetuses(
litters)
examined
for
external
and
skeletal
malformations/
variations
was
288(
22),
305(
23),
297(
22),
and
279(
20),
respectively,
and
for
visceral
malformations/
variations
was
138(
22),
149(
23),
144(
22),
and
134(
20),
respectively.
No
treatment
related
external
or
visceral
malformations/
variations
were
observed
in
any
group.
Diuron
16
Delayed
ossification
of
the
vertebrae
and
sternebrae
was
observed
in
fetuses
of
the
high
dose
group.
In
the
0,
16,
80,
and
400
mg/
kg/
day
groups
the
incidence
rates
for
litters
containing
fetuses
with
bifid
thoracic
vertebral
centra
was
1/
22,
1/
23,
2/
22,
and
7/
20
(
p
#
0.05),
respectively.
Incomplete
ossification
of
the
sternebrae
was
observed
in
fetuses
from
3/
22,
3/
23,
1/
22,
and
9/
20
(
p
#
0.05),
litters
respectively.
Unossified
thoracic
vertebral
centra
was
observed
in
fetuses
from
3/
20
(
p
#
0.05)
high
dose
litters
but
not
in
fetuses
from
the
other
treated
or
control
groups.
The
developmental
toxicity
LOAEL
is
established
at
400
mg/
kg/
day
based
on
whole
litter
resorption,
reduced
fetal
body
weights,
and
delayed
ossification
of
the
vertebrae
and
sternebrae.
The
developmental
toxicity
NOAEL
is
80
mg/
kg/
day.
This
study
is
classified
as
Unacceptable
and
does
not
satisfy
the
requirements
for
a
developmental
toxicity
study
[
870.3700
(
§
83
3a)]
in
rats.
Test
article
concentrations
in
the
mid
and
high
dose
solutions
were
highly
variable
and
well
outside
of
acceptable
ranges.
Based
upon
available
analytical
data,
it
appears
that
target
doses
may
not
have
been
representative
of
the
actual
doses
to
the
animals.
In
addition,
the
lot
number
and
corresponding
analyses
were
not
provided.
It
is
unlikely
that
this
study
may
be
upgraded.
However,
the
HIARC
determined
that
this
study
is
adequate
for
the
assessment
of
susceptibility
in
rats.
This
decision
was
made
based
on
the
fact
that
maternal
toxicity
was
seen
at
a
lower
dose
(
80
mg/
kg/
day)
compared
to
developmental
toxicity
(
400
mg/
kg/
day).
At
400
mg/
kg/
say,
developmental
effects
(
increased
incidence
of
early
resorption
and
decreased
fetal
body
weight)
were
seen
in
the
presence
of
maternal
toxicity
(
significantly
decreased
body
weight
gain
and
food
consumption).
The
HIARC
also
determined
that
a
repeat
of
this
study
is
not
required
since
the
effects
of
the
range
finding
study
showed
maternal
toxicity
(
decreased
body
weight
gain
and
food
consumption)
at
100,
200,
and
400
mg/
kg/
day
and
developmental
toxicity
(
increased
incidence
of
early
resorption
and
decreased
fetal
body
weight)
at
400
mg/
kg/
day.
Also,
the
rabbit
was
shown
to
be
the
more
susceptible
species
for
developmental
toxicity
study.
A
repeat
rat
study
would
not
provide
additional
data
for
risk
assessment/
risk
characterization.
4.4
Reproductive
Toxicity
In
a
two
generation
reproduction
study
Diuron
(
97.1%
a.
i.,
Lot
No.
8805540)
was
administered
to
groups
of
30
male
and
30
female
Crl:
CD
®
BR
rats
in
the
diet
at
concentrations
of
0,
10,
250,
or
1750
ppm
(
MRID
41957301).
One
litter
was
produced
by
each
generation.
Test
substance
intake
for
the
treated
F0
groups
was
0.58,
14.8,
and
101
mg/
kg/
day,
respectively,
for
males
and
0.71,
18.5,
and
131
mg/
kg/
day,
respectively,
for
females.
Test
substance
intake
for
the
treated
F1
groups
was
0.77,
18.9,
and
139
mg/
kg/
day,
respectively,
Diuron
17
for
males
and
0.8,
22.1,
and
157
mg/
kg/
day,
respectively,
for
females.
F0
and
F1
parental
animals
were
administered
test
or
control
diet
for
73
or
105
days,
respectively,
prior
to
mating
and
throughout
mating,
gestation,
and
lactation,
and
until
necropsy.
Deaths
or
premature
sacrifices
of
several
F0
and
F1
parental
animals
were
considered
incidental
to
treatment.
No
treatment
related
clinical
signs
of
toxicity
were
observed
in
the
adult
animals
of
either
generation.
Gross
necropsy
was
unremarkable
and
testes
weights
were
not
affected
by
treatment.
For
the
low
and
mid
dose
groups
of
both
generations,
occasional
significant
differences
from
the
control
group
for
body
weights,
body
weight
gains,
food
consumption,
and
food
efficiencies
were
considered
incidental
to
treatment.
Body
weights
of
the
high
dose
F0
males
and
females
were
significantly
(
p
#
0.05)
decreased
by
an
average
of
7%
beginning
on
day
7.
Body
weight
gains
by
the
high
dose
F0
males
were
significantly
(
p
#
0.05)
less
than
the
control
group
on
days
0
14,
21
28,
42
49,
77
84,
and
91
98.
Premating,
post
mating,
and
overall
(
entire
study)
body
weight
gains
by
the
F0
males
were
significantly
(
p
#
0.05)
decreased
by
16%,
28%,
and
18%,
respectively,
compared
with
the
controls.
Body
weight
gains
by
the
high
dose
F0
females
were
significantly
(
p
#
0.05)
less
than
the
control
group
on
days
0
14
and
21
28
with
overall
premating
body
weight
gains
significantly
(
p
#
0.05)
decreased
by
28%
compared
with
the
controls.
Significant
(
p
#
0.05)
reductions
in
food
consumption
were
observed
in
the
high
dose
F0
males
and
females
on
days
0
14,
21
28,
35
49
(
females),
42
56
(
males),
and
0
70.
Food
efficiencies
for
the
F0
males
and
females
were
significantly
(
p
#
0.05)
reduced
at
similar
intervals
to
food
consumption
with
overall
premating
food
efficiency
reduced
by
8.3%
and
22.7%,
respectively.
Body
weights
of
the
high
dose
F1
males
and
females
were
significantly
(
p
#
0.05)
decreased
by
an
average
of
16%
beginning
on
day
0
of
premating.
Body
weight
gains
by
the
high
dose
F1
males
were
significantly
(
p
#
0.05)
less
than
the
control
group
on
days
0
28,
42
49,
63
70,
91
98,
and
147
154.
Premating,
post
mating,
and
overall
(
entire
study)
body
weight
gains
by
the
F1
males
were
significantly
(
p
#
0.05)
decreased
by
15%,
41%,
and
17%,
respectively,
compared
with
the
controls.
Body
weight
gains
by
the
high
dose
F1
females
were
significantly
(
p
#
0.05)
less
than
the
control
group
on
days
0
14
with
overall
premating
body
weight
gains
significantly
(
p
#
0.05)
decreased
by
14%
compared
with
the
controls.
Significant
(
p
#
0.05)
reductions
in
food
consumption
were
observed
in
the
high
dose
F0
males
and
females
throughout
premating
with
the
exception
of
days
77
84
for
males.
Food
efficiencies
were
significantly
(
p
#
0.05)
reduced
for
the
high
dose
F1
males
on
days
91
98
and
for
the
high
dose
F1
females
on
days
0
7,
21
28,
and
0
70.
Diuron
18
The
systemic
toxicity
LOAEL
is
1750
ppm
(
approximately
132
mg/
kg/
day)
based
on
reduced
body
weight,
body
weight
gain,
food
consumption,
and
food
efficiency
during
both
generations.
The
systemic
toxicity
NOAEL
is
250
ppm
(
approximately
18.6
mg/
kg/
day).
For
the
F0
and
F1
females,
reduced
body
weights
and
food
consumption
during
gestation
were
considered
a
continuation
of
premating
effects.
No
treatment
related
effects
were
noted
in
either
generation
on
fertility
indices,
gestation
length,
pup
survival,
pup
clinical
observations,
and
pup
anomalies.
Pup
body
weights
for
sexes
combined
or
separate
were
significantly
(
p
#
0.05)
reduced
in
high
dose
litters
as
compared
with
the
controls
throughout
lactation
for
the
F1
pups
and
beginning
on
lactation
day
7
for
the
F2
pups.
The
offspring
toxicity
LOAEL
is
1750
ppm
(
approximately
132
mg/
kg/
day)
based
on
decreased
body
weights
of
the
F1
and
F2
pups
during
lactation.
The
offspring
toxicity
NOAEL
is
250
ppm
(
18.6
mg/
kg/
day).
The
reproductive
toxicity
NOAEL
is
1750
ppm
(
HDT).
This
study
is
classified
as
Acceptable/
Guideline
and
satisfies
the
guideline
requirements
for
a
reproductive
toxicity
study
[
OPPTS
870.3800
(
§
83
4)]
in
rats.
4.5
Additional
Information
from
Literature
Sources
Literature
searches
have
been
conducted
and
no
additional
neurotoxicity,
developmental
or
reproductive
toxicity
was
found.
4.6
Determination
of
Susceptibility
Base
on
the
developmental
and
reproductive
toxicity
studies,
there
was
no
evidence
(
qualitative
or
quantitative)
for
increased
susceptibility
following
in
utero
and/
or
pre/
post
natal
exposure.
4.7
Recommendation
for
a
Developmental
Neurotoxicity
Study
There
are
no
evidence
that
suggest
requiring
a
developmental
neurotoxicity
study.
The
Diuron
19
developmental
toxicity
studies
in
rats
and
rabbits
as
well
as
the
reproductive
toxicity
study
in
rats
did
not
show
any
adverse
effects
below
maternal
or
parental
doses.
5
HAZARD
CHARACTERIZATION
Diuron
is
a
substituted
urea
herbicide
for
the
control
of
a
wide
variety
of
annual
and
perennial
broadleaved
and
grassy
weeds
on
both
crop
and
noncrop
sites.
The
mechanism
of
action
is
the
inhibition
of
photosynthesis.
Diuron
has
a
low
acute
toxicity
(
Tox.
Cat.
3
or
4)
by
oral,
dermal,
or
inhalation
route
exposure.
Diuron
is
not
an
eye
or
skin
irritant
and
not
a
skin
sensitizer.
A
rat
metabolism
study
indicated
that
diuron
is
rapidly
absorbed
and
metabolized
within
24
hours
post
dose
at
low
dose
and
within
48
hours
post
dose
at
high
dose.
The
urine
is
the
major
route
of
excretion
in
both
sexes.
A
small
amount
of
diuron
is
detected
in
the
feces.
The
highest
tissue
residue
levels
were
found
in
the
liver
and
kidneys
4
days
post
14C
diuron
dose.
Metabolism
of
diuron
involved
N
oxidation,
ring
hydroxylation,
demethylation,
dechlorination,
and
conjugation
to
sulfate
and
glucuronic
acid.
The
primary
diuron
target
organs
are
hematopoietic
system
and
bladder
(
and
renal
pelvis).
Erythrocyte
damage
resulted
in
hemolytic
anemia
and
compensatory
hematopoiesis,
which
are
manifested
as
significantly
decreased
erythrocyte
counts,
hemoglobin
levels,
and
hematocrit,
and
increased
MCV,
MCH,
abnormal
erythrocyte
forms,
reticulocyte
counts,
and
leukocyte
count.
Consistent
observations
of
erythocytic
regeneration
are
seen
in
chronic
toxicity
studies
in
rats,
mice
and
dogs.
Gross
pathology
findings
in
chronic
rat
and
mouse
studies
showed
increased
incidences
of
urinary
bladder
edema
and
wall
thickening
at
high
doses.
Microscopic
evaluation
showed
dose
related
increases
in
the
severity
of
epithelial
focal
hyperplasia
of
the
urinary
bladder
and
renal
pelvis
in
both
sexes.
Although
the
developmental
toxicity
studies
in
rats
is
classified
unacceptable,
the
data
base
on
diuron
are
adequate
for
pre
and
post
natal
toxicity
evaluation
and
did
not
reveal
developmental
or
reproductive
toxicity.
The
NOAELs
for
maternal/
parental
toxicity
were
either
less
than
or
equal
to
the
NOAELs
for
fetal
or
reproductive
toxicity
The
HED
Carcinogenicity
Peer
Review
Committee
(
CPRC)
characterized
diuron
as
a
"
known/
likely"
human
carcinogen
by
all
routes,
based
on
urinary
bladder
carcinoma
in
both
sexes
of
the
Wistar
rat,
kidney
carcinomas
in
the
male
rat
(
a
rare
tumor),
and
mammary
gland
carcinomas
in
the
female
NMRI
mouse.
The
CPRC
also
recommended
a
low
dose
linear
extrapolation
model
with
Q1
*
(
mg/
kg/
day)
1
of
1.91x10
2
be
applied
to
the
animal
data
for
the
quantification
of
human
risk,
based
on
the
urinary
bladder
carcinomas
in
the
rat.
Diuron
20
6
DATA
GAPS
The
HIARC
determined
that
a
28
day
inhalation
study
is
required
to
address
the
concern
for
inhalation
exposure
potential
based
on
the
use
pattern.
The
Registrant
can
follow
the
90
day
inhalation
study
protocol
but
cease
exposure
at
28
days.
The
HIARC
also
determined
that
a
repeated
chronic
dog
study
is
not
required
because
a
new
study
would
not
provide
additional
data
since
the
observed
effects
are
similar
in
the
rat
and
the
rat
is
the
more
sensitive
species
for
this
chemical.
Diuron
21
7
ACUTE
TOXICITY
Acute
Toxicity
of
Diuron
Guideline
No.
Study
Type
MRIDs
#
Results
Toxicity
Category
81
1
Acute
Oral
00146144
LD50
=
4721
mg/
kg
(
M)
>
5000
mg/
kg
(
F)
III
81
2
Acute
Dermal
00146146
LD50
>
2000
mg/
kg
III
81
3
Acute
Inhalation
40228803
LC50
>
7.1
mg/
L
IV
81
4
Primary
Eye
Irritation
00146147
At
48
hrs,
all
irritation
had
cleared.
III
81
5
Primary
Skin
Irritation
00146148
All
irritation
had
cleared
by
72
hrs.
IV
81
6
Dermal
Sensitization
00146149
Nonsensitizer
N/
A
81
8
Acute
Neurotoxicity
N/
A
Not
available
N/
A
Diuron
22
8.
SUMMARY
OF
TOXICOLOGY
ENDPOINT
SELECTION
The
doses
and
toxicological
endpoints
selected
for
various
exposure
scenarios
are
summarized
below.
EXPOSURE
SCENARIO
DOSE
(
mg/
kg/
day)
ENDPOINT
STUDY
Acute
Dietary
There
is
no
appropriate
endpoint
attributed
to
a
single
dose
was
identified.
Therefore,
an
acute
RfD
was
not
established.
Chronic
Dietary
LOAEL
=
1.0
UF
=
300
Evidence
of
hemolytic
anemia
and
compensatory
hematopoiesis.
Chronic
toxicity/
carcinogenicity
study
in
rats
Chronic
RfD
=
0.003
mg/
kg/
day
Cancer
Known/
likely
human
carcinogen
Q1*
=
1.91
x
10
2
Urinary
bladder
carcinoma
in
both
sexes
of
the
Wistar
rat,
kidney
carcinomas
in
the
male
rat
(
a
rare
tumor),
and
mammary
gland
carcinomas
in
the
female
NMRI
mouse
Carcinogenicity
study
in
rats
and
mice
Incidental
Oral,
short
Term
NOAEL=
10
Decreased
body
weight
and
food
consumption
Developmental
toxicity
study
in
rabbits
Incidental
Oral,
Intermediate
Term
NOAEL
=
1.0
Altered
hematological
parameters
observed
at
6
months.
Chronic
toxicity/
carcinogenicity
study
in
rats
Dermal,
Short
Intermediate
Term
No
systemic
toxicity
following
repeated
dermal
dosing
at
1200
mg/
kg/
day
was
seen
in
the
dermal
toxicity
study.
Also,
there
is
no
developmental
concern.
No
hazard
was
identified
and
no
quantitative
assessment
is
required.
Dermal,
Long
Terma
LOAEL
=
1.0
Evidence
of
hemolytic
anemia
and
compensatory
hematopoiesis.
Chronic
toxicity/
carcinogenicity
study
in
rats
Inhalation,
Short
Termb
NOAEL
=
10
Decreased
body
weight
and
food
consumption
Developmental
toxicity
study
in
rabbits
Inhalation,
Intermediate
Termb
NOAEL
=
1.0
Altered
hematological
parameters
observed
at
6
months.
Chronic
toxicity/
carcinogenicity
study
in
rats
Inhalation,
Long
Termb
LOAEL
=
1.0
Evidence
of
hemolytic
anemia
and
compensatory
hematopoiesis.
Chronic
toxicity/
carcinogenicity
study
in
rats
a
An
oral
endpoint
was
used
for
dermal
exposure:
dermal
absorption
factor
of
4%
of
oral
exposure
shall
be
used.
b
An
oral
endpoint
was
used
for
inhalation
exposure:
inhalation
exposure
assumed
equivalent
to
oral
exposure.
| epa | 2024-06-07T20:31:43.626327 | regulations | {
"license": "Public Domain",
"url": "https://downloads.regulations.gov/EPA-HQ-OPP-2002-0249-0013/content.txt"
} |
EPA-HQ-OPP-2002-0249-0015 | Supporting & Related Material | "2002-10-01T04:00:00" | null | UNITED
STATES
ENVIRONMENTAL
PROTECTION
AGENCY
WASHINGTON,
D.
C.
20460
OFFICE
OF
PREVENTION,
PESTICIDES
AND
TOXIC
SUBSTANCES
TXR:
0050570
Date:
March
6,
2002
MEMORANDUM
SUBJECT:
Diuron
Phase
2:
Revised
Toxicology
Disciplinary
Chapter
for
the
Reregistration
Eligibility
Decision
FROM:
Yung
G.
Yang,
Ph.
D.,
Toxicologist
Toxicology
Branch
Health
Effects
Division
(
7509C)
THROUGH:
Alan
Nielsen,
Branch
Senior
Scientist
Reregistration
Branch
II
Health
Effects
Division
(
7509C)
TO:
Carol
Christensen,
Risk
Assessor
Reregistration
Branch
II
Health
Effects
Division
(
7509C)
PC
Code:
035505
Chemicals:
Diuron
DP
BARCODE:
D281425
Submission:
S611595
Case:
818790
ACTION
REQUESTED:
Prepare
a
toxicology
chapter
for
diuron
to
reflect
comments
received
from
the
Registrant
in
Phase
1
of
the
public
participation
process.
RESPONSE:
The
toxicology
chapter
has
been
revised
to
reflect
comments
received
from
the
Registrant.
A
revised
toxicology
chapter
for
diuron
is
as
follows.
2
DIURON
PC
Codes:
035505
Toxicology
Disciplinary
Chapter
for
the
Reregistration
Eligibility
Decision
March
6,
2002
Prepared
by:
Yung
G.
Yang,
Ph.
D.
Toxicology
Branch
Health
Effects
Division
Mail
Code
7509C
Peer
Reviewed
by:
Alan
Nielsen
Branch
Senior
Scientist
Reregistration
Branch
II
Health
Effects
Division
Mail
Code
7509C
Yung
G.
Yang,
Toxicologist
Alan
Nielsen,
Branch
Senior
Scientist
3
TABLE
OF
CONTENTS
1.0
HAZARD
CHARACTERIZATION
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
4
2.0
REQUIREMENTS
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
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6
3.0
DATA
GAP(
S)
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7
4.0
HAZARD
ASSESSMENT
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7
4.1
Acute
Toxicity
.
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7
4.2
Subchronic
Toxicity
.
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7
4.3
Prenatal
Developmental
Toxicity
.
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10
4.4
Reproductive
Toxicity
.
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12
4.5
Chronic
Toxicity
.
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.
14
4.6
Carcinogenicity
.
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17
4.7
Mutagenicity
.
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19
4.8
Neurotoxicity
.
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21
4.9
Metabolism
.
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21
5.0
TOXICITY
ENDPOINT
SELECTION
.
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22
5.1
See
Section
9.2
for
Endpoint
Selection
Table.
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22
5.2
Dermal
Absorption
.
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22
5.3
Classification
of
Carcinogenic
Potential
.
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23
6.0
FQPA
CONSIDERATIONS
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.
23
6.1
Special
Sensitivity
to
Infants
and
Children
.
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23
6.2
Recommendation
for
a
Developmental
Neurotoxicity
Study
.
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.
23
8.0
REFERENCES
.
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23
9.0
APPENDICES
.
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27
9.1
Toxicity
Profile
Summary
Tables
.
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28
9.1.1
Acute
Toxicity
Table
.
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28
9.1.2
Subchronic,
Chronic
and
Other
Toxicity
Tables
.
.
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28
9.2
Summary
of
Toxicological
Dose
and
Endpoints
.
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.
32
Diuron
RED
Toxicology
Chapter
4
1.0
HAZARD
CHARACTERIZATION
The
toxicity
database
for
diuron
is
adequate
to
assess
the
potential
hazard
to
humans,
including
special
sensitivity
of
infants
and
children.
The
database
will
support
a
reregistration
eligibility
decision
(
RED)
for
the
currently
registered
uses.
However,
a
new
28
day
inhalation
toxicity
study
has
been
required
to
provide
better
hazard
characterization.
Diuron
is
a
substituted
urea
herbicide
for
the
control
of
a
wide
variety
of
annual
and
perennial
broadleaved
and
grassy
weeds
on
both
crop
and
noncrop
sites.
Diuron
has
a
low
acute
toxicity
(
Toxicity
Category
3
or
4)
by
oral,
dermal,
or
inhalation
route
exposure.
Diuron
is
not
an
eye
or
skin
irritant
and
not
a
skin
sensitizer.
The
primary
diuron
target
organs
are
hematopoietic
system
and
bladder
(
and
renal
pelvis).
Exposure
to
diuron
causes
erythrocyte
damage
resulting
in
hemolytic
anemia
and
compensatory
hematopoiesis,
which
are
manifested
as
significantly
decreased
erythrocyte
counts,
hemoglobin
levels,
and
hematocrit,
and
increased
MCV,
MCH,
abnormal
erythrocyte
forms,
reticulocyte
counts,
and
leukocyte
count.
Consistent
observations
of
erythocytic
regeneration
are
seen
in
chronic
toxicity
studies
in
rats,
mice
and
dogs.
No
evidence
of
neurotoxicity
was
observed
in
the
rat,
rabbit,
or
dog
in
any
of
the
subchronic
or
chronic
studies.
Results
from
developmental
and
reproductive
toxicity
studies
indicated
that
there
was
no
evidence
(
qualitative
or
quantitative)
for
increased
susceptibility
following
in
utero
and/
or
pre/
postnatal
exposure.
Administration
of
diuron
in
the
diet
to
rats
and
mice
resulted
in
increases
in
urinary
bladder
carcinomas
in
rats
of
both
sexes
at
the
highest
dose
and
mammary
gland
adenocarcinomas
in
female
mice.
Gross
pathology
findings
in
chronic
rat
and
mouse
studies
showed
increased
incidences
of
urinary
bladder
edema
and
wall
thickening
at
high
doses.
Microscopic
evaluation
showed
dose
related
increases
in
the
severity
of
epithelial
focal
hyperplasia
of
the
urinary
bladder
and
renal
pelvis
in
both
sexes.
These
findings
provide
further
support
that
the
increase
of
bladder
tumors
is
compound
related.
Diuron
has
been
reviewed
by
the
HED
Carcinogenicity
Peer
Review
Committee
(
CPRC)
and
is
classified
as
a
"
known/
likely"
human
carcinogen
based
on
urinary
bladder
carcinoma
in
both
sexes
of
the
Wistar
rat,
kidney
carcinomas
in
the
male
rat
(
a
rare
tumor),
and
mammary
gland
carcinomas
in
the
female
NMRI
mouse.
The
CPRC
also
recommended
a
low
dose
linear
extrapolation
model
with
Q1
*
of
1.91x10
2
(
mg/
kg/
day)
1
be
applied
to
the
animal
data
for
the
quantification
of
human
risk,
based
on
the
urinary
bladder
carcinomas
in
the
rat.
A
proposed
mode
of
action
on
bladder
carcinogenicity
has
been
submitted
by
the
Registrant.
The
HED
Mechanism
of
Toxicity
Assessment
Review
Committee
(
MTARC)
reviewed
the
proposed
mode
of
Diuron
RED
Toxicology
Chapter
5
action
and
concluded
that
the
submitted
information
is
insufficient
to
support
a
mode
of
action
on
bladder
carcinogenicity
for
diuron.
Diuron
will
not
be
re
classified
at
this
time.
A
rat
metabolism
study
indicated
that
diuron
is
rapidly
absorbed
and
metabolized
within
24
hours
postdose
at
low
dose
and
within
48
hours
post
dose
at
high
dose.
The
urine
is
the
major
route
of
excretion
in
both
sexes.
A
small
amount
of
diuron
is
detected
in
the
feces.
No
apparent
difference
was
observed
between
single
and
multiple
low
oral
doses.
There
was
no
apparent
sex
related
difference
in
either
absorption
or
elimination.
Metabolism
of
diuron
involved
N
oxidation,
ring
hydroxylation,
demethylation,
dechlorination,
and
conjugation
to
sulfate
and
glucuronic
acid.
The
major
urine
metabolite
was
IN
R915
(
3,4
dichlorophenylurea),
which
accounted
for
>
20%
of
the
total
administered
dose.
Other
metabolites
were
glucuronide
conjugates,
sulfate
conjugates
and
free
metabolites.
Diuron
RED
Toxicology
Chapter
6
2.0
REQUIREMENTS
The
requirements
(
CFR
158.340)
for
food
use
for
Diuron
are
in
Table
1.
Use
of
the
new
guideline
numbers
does
not
imply
that
the
new
(
1998)
guideline
protocols
were
used.
Table
1.
Test
Technical
Required
Satisfied
870.1100
Acute
Oral
Toxicity
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
870.1200
Acute
Dermal
Toxicity
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
870.1300
Acute
Inhalation
Toxicity
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
870.2400
Primary
Eye
Irritation
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
870.2500
Primary
Dermal
Irritation
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
870.2600
Dermal
Sensitization
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
yes
yes
yes
yes
yes
yes
yes
yes
yes
yes
yes
yes
870.3100
Oral
Subchronic
(
rodent)
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
870.3150
Oral
Subchronic
(
nonrodent)
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
870.3200
21
Day
Dermal
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
870.3250
90
Day
Dermal
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
870.3465
90
Day
Inhalation
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
yes
yes
yes
no
yes2
yes1
yes1
yes
no
no2
870.3700a
Developmental
Toxicity
(
rodent)
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
870.3700b
Developmental
Toxicity
(
nonrodent)
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
870.3800
Reproduction
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
yes
yes
yes
yes3
yes
yes
870.4100a
Chronic
Toxicity
(
rodent)
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
870.4100b
Chronic
Toxicity
(
nonrodent)
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
870.4200a
Oncogenicity
(
rat)
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
870.4200b
Oncogenicity
(
mouse)
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
870.4300
Chronic/
Oncogenicity
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
yes
yes
yes
yes
yes
yes
yes4
yes
yes
yes
870.5100
Mutagenicity
Gene
Mutation
bacterial
.
.
.
.
.
.
.
.
.
.
.
870.5300
Mutagenicity
Gene
Mutation
mammalian
.
.
.
.
.
.
.
.
.
870.5375
Mutagenicity
Structural
Chromosomal
Aberrations
.
870.5550
Mutagenicity
Other
Genotoxic
Effects
.
.
.
.
.
.
.
.
.
.
.
.
yes
yes
yes
yes
yes
yes
yes
yes
870.6100a
Acute
Delayed
Neurotox.
(
hen)
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
870.6100b
90
Day
Neurotoxicity
(
hen)
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
870.6200a
Acute
Neurotox.
Screening
Battery
(
rat)
.
.
.
.
.
.
.
.
.
.
.
.
870.6200b
90
Day
Neuro.
Screening
Battery
(
rat)
.
.
.
.
.
.
.
.
.
.
.
.
.
.
870.6300
Develop.
Neuro
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
no
no
no
no
no
no
no
no
no
no
870.7485
General
Metabolism
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
870.7600
Dermal
Penetration
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
yes
no
yes
no
Special
Studies
for
Ocular
Effects
Acute
Oral
(
rat)
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
Subchronic
Oral
(
rat)
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
Six
month
Oral
(
dog)
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
no
no
no
no
no
no
1.
Requirements
are
satisfied
by
chronic
oral
toxicity
studies.
2.
The
HIARC
determined
that
a
28
Day
inhalation
toxicity
study
is
required
(
5/
29/
2001).
3.
The
HIARC
determined
that
this
study
is
adequate
for
assessment
of
susceptibility
(
5/
29/
2001).
4.
The
HIARC
determined
that
a
repeated
chronic
dog
study
is
not
required
(
5/
29/
2001).
Diuron
RED
Toxicology
Chapter
7
3.0
DATA
GAP(
S)
28
day
subchronic
inhalation
toxicity,
OPPTS
870.3465
4.0
HAZARD
ASSESSMENT
4.1
Acute
Toxicity
Adequacy
of
data
base
for
acute
toxicity:
The
data
base
for
acute
toxicity
is
considered
adequate.
No
additional
studies
are
required
at
this
time.
Diuron
has
low
acute
oral
and
dermal
toxicity
(
Category
III)
and
low
acute
inhalation
toxicity
(
Category
IV).
Diuron
is
not
an
eye
or
skin
irritant
and
not
a
skin
sensitizer.
Acute
Toxicity
of
Diuron
OPPTS
Guideline
No.
Study
Type
MRIDs
#
Results
Toxicity
Category
870.1100
Acute
Oral,
rat
00146144
LD50
=
4721
mg/
kg
(
M)
>
5000
mg/
kg
(
F)
III
870.1200
Acute
Dermal,
rat
00146146
LD50
>
2000
mg/
kg
III
870.1300
Acute
Inhalation,
rat
40228803
LD50
>
7.1
mg/
L
IV
870.2400
Primary
Eye
Irritation,
rabbit
00146147
At
48
hrs,
all
irritation
had
cleared.
III
870.2500
Primary
Skin
Irritation,
rabbit
00146148
All
irritation
had
cleared
by
72
hrs.
IV
870.2600
Dermal
Sensitization,
guinea
pig
00146149
Nonsensitizer
N/
A
N/
A:
Not
applicable.
4.2
Subchronic
Toxicity
Adequacy
of
database
for
subchronic
toxicity:
The
database
for
subchronic
toxicity
is
incomplete;
however,
chronic
studies
are
available
and
considered
adequate
for
risk
assessment
purposes.
A
28
day
inhalation
toxicity
study
is
required
at
this
time
to
address
the
concern
for
inhalation
exposure
potential
based
on
the
use
pattern
(
HIARC,
5/
29/
2001).
Diuron
RED
Toxicology
Chapter
8
870.3100
90
Day
Oral
Toxicity
Rat
EXECUTIVE
SUMMARY:
In
a
6
month
oral
toxicity
study
(
MRID
40886502),
Diuron
(
98.8%
a.
i.,
Lot
No.
232114123)
was
administered
to
groups
of
10
male
and
10
female
BOR:
WISW
(
SPF
Cpb)
rats
in
the
diet
at
concentrations
of
0,
4,
10,
or
25
ppm.
Time
weighted
average
doses
were
0,
0.3,
0.7,
and
1.6
mg/
kg/
day,
respectively,
for
males
and
0,
0.3,
0.8,
and
1.8
mg/
kg/
day,
respectively,
for
females.
Deaths
of
one
mid
dose
male
and
one
mid
dose
female
after
blood
collection
during
week
12
were
considered
incidental
to
treatment;
all
remaining
animals
survived
to
scheduled
sacrifice.
No
treatmentrelated
clinical
signs
of
toxicity
were
observed
in
any
animal.
Body
weights,
food
consumption,
differential
blood
counts,
erythrocyte
morphology,
and
organ
weights
were
unaffected
by
treatment.
Reticulocyte
counts
in
the
high
dose
females
were
increased
at
all
intervals
with
statistical
significance
(
p
#
0.05)
attained
at
weeks
12
and
26
(
150
165%
of
control
values).
Mean
hemoglobin
concentrations
in
the
high
dose
females
were
slightly
(
n.
s.)
depressed
at
all
intervals
as
compared
to
the
controls
(
within
5%
of
control
levels).
Increased
incidences
of
gross
lesions
on
the
urinary
bladder
were
observed
in
all
treated
groups
of
males
and
females.
In
the
control,
low,
mid,
and
high
dose
groups,
dilated
blood
vessels
were
observed
in
0/
10,
3/
10,
1/
10,
and
3/
10
males,
respectively,
and
in
1/
10,
3/
10,
3/
10,
and
5/
10
females,
respectively;
increased
firmness
was
observed
in
0/
10,
1/
10,
2/
10,
and
3/
10
males,
respectively,
and
in
0/
10,
5/
10,
2/
10,
and
3/
10
females,
respectively;
and
reduced
transparency
was
observed
in
0/
10,
1/
10,
1/
10,
and
2/
10
females,
respectively.
Microscopic
examinations
and
morphometric
measurements
of
the
urinary
bladder
were
done
in
an
attempt
to
characterize
the
gross
findings.
Hyperplasia
of
the
epithelium
was
observed
in
1
low
dose
male,
1
control
female,
2
low
dose
females,
and
2
high
dose
females.
Thickening
of
the
epithelium
by
enlargement
of
the
epithelial
cells
(
hypertrophy)
was
seen
in
2
low
dose
males
and
1
high
dose
male.
In
females
from
the
control,
low,
mid,
and
high
dose
groups,
the
thickness
of
the
urinary
bladder
wall
was
437,
492,
448,
and
486
µ
m,
respectively;
males
were
not
measured.
These
observations
are
judged
to
be
equivocal.
Pigment
deposition
(
iron)
in
the
spleen
was
observed
in
all
treated
and
control
animals,
however,
the
severity
and
extent
were
increased
in
the
high
dose
groups.
In
the
control,
low,
mid,
and
high
dose
groups,
severity
ratings
were
2.3,
2.3,
2.3,
and
3.0,
respectively
for
males,
and
2.5,
3.1,
2.9,
and
3.7,
respectively,
for
females
(
based
on
a
scale
of
increasing
severity
of
1
5).
Morphometric
measurements
showed
the
percent
area
of
iron
deposits
to
be
8.4,
10.1,
9.8,
and
14.1,
respectively,
for
males,
and
14.7,
15.7,
15.1,
and
19.4,
respectively,
for
females.
Diuron
RED
Toxicology
Chapter
9
Under
the
study
condition,
the
NOAEL
can
not
be
determined
because
some
findings
were
judged
to
be
equivocal.
This
study
is
not
designed
for
a
guideline
study
and
is
classified
as
acceptable/
nonguideline
as
a
supplementary
subchronic
study
in
rats.
870.3100
90
Day
Oral
Toxicity
Mouse
No
study
is
available.
870.3150
90
Day
Oral
Toxicity
Dog
No
study
is
available.
870.3465
90
Day
Inhalation
Rat
No
study
is
available.
The
HIARC
(
5/
29/
2001)
determined
that
a
28
day
inhalation
study
is
required
to
address
the
concern
for
inhalation
exposure
potential
based
on
use
pattern.
870.3200
21
Day
Dermal
Toxicity
Rabbit
EXECUTIVE
SUMMARY:
In
a
21
day
dermal
toxicity
study
(
MRID
42718301),
diuron
(
98.6%)
was
administered
dermally
at
0
(
deionized
water),
50,
500
and
1200
mg/
kg/
day
to
5
New
Zealand
White
rabbits/
sex/
dose
for
6
hours/
day.
Diuron
was
administered
on
the
backs
of
rabbits
whose
hair
was
clipped.
Body
weight,
food
consumption,
clinical
signs,
mortality,
clinical
chemistry,
hematology,
gross
pathology,
histopathology,
and
organ
weights
were
observed.
Erythema
and
edema
were
scored
using
the
Draize
scoring
system.
There
were
no
treatment
related
effects
on
clinical
signs,
body
weight,
body
weight
gain,
food
consumption,
hematology,
organ
weights,
or
histopathology
parameters
were
noted.
In
treatment
and
control
groups,
slight
to
mild
erythema
was
observed
by
days
10
14
and
was
attributed
to
mechanical
skin
injury
from
experimental
treatment.
In
the
1200
mg/
kg/
day
group,
moderate
erythema
was
noted
at
1200
mg/
kg/
day
in
2
of
5
females.
Slight
or
mild
edema
was
noted
in
one
male
and
one
female,
respectively,
of
the
1200
mg/
kg/
day
group.
The
systemic
toxicity
NOAEL
for
21
day
dermal
toxicity
study
is
1200
mg/
kg/
day
(
HDT).
This
study
is
classified
acceptable/
guideline
and
satisfies
the
guideline
requirement
for
a
subchronic
dermal
study
in
rabbits.
Diuron
RED
Toxicology
Chapter
10
4.3
Prenatal
Developmental
Toxicity
Adequacy
of
database
for
Prenatal
Developmental
Toxicity:
The
database
for
prenatal
developmental
toxicity
is
considered
adequate.
No
additional
studies
are
required
at
this
time.
There
is
no
quantitative
or
qualitative
evidence
of
increased
susceptibility
of
rats
or
rabbit
fetuses
to
in
utero
exposure
in
available
developmental
toxicities.
870.3700a
Prenatal
Developmental
Toxicity
Study
Rat
EXECUTIVE
SUMMARY:
In
a
developmental
toxicity
study
(
MRID
40228801),
25
presumed
pregnant
Crl:
COBS
®
CD
®
(
SD)
BR
rats
per
group
were
administered
H
16035
(
99%;
Lot
No.
not
given)
by
gavage
in
0.5%
aqueous
hydroxypropyl
methylcellulose
at
doses
of
0,
16,
80,
or
400
mg/
kg/
day
on
gestation
days
(
GD)
6
15,
inclusive.
On
GD
20,
dams
were
sacrificed,
subjected
to
gross
necropsy,
and
all
fetuses
were
examined
externally.
Approximately
one
half
of
all
fetuses
were
examined
viscerally
by
the
Staples
technique;
these
fetuses
were
decapitated,
and
the
heads
fixed
in
Bouin's
solution
for
subsequent
free
hand
sectioning.
The
remaining
one
half
of
the
fetuses
were
eviscerated
and
all
carcasses
were
processed
for
skeletal
examination.
All
dams
survived
to
terminal
sacrifice.
One
high
dose
animal
appeared
thin
on
GD
13
18
as
a
result
of
marked
weight
loss.
No
other
treatment
related
clinical
signs
of
toxicity
were
observed
in
any
group.
Body
weights,
body
weight
gains,
and
food
consumption
by
the
low
dose
group
were
similar
to
the
controls
throughout
the
study.
No
treatment
related
lesions
were
observed
in
any
dam
at
necropsy.
Absolute
body
weights
of
the
mid
and
high
dose
groups
were
significantly
(
p
#
0.01)
less
than
the
controls
during
the
dosing
interval
and
ranged
from
92
94%
and
84
88%,
respectively,
of
the
control
levels.
Body
weight
gains
by
the
mid
and
high
dose
dams
were
significantly
(
p
#
0.05
or
0.01)
less
than
that
of
the
controls
during
the
dosing
period
with
the
exception
of
GD
12
16.
The
most
pronounced
effect
on
body
weight
gain
occurred
immediately
after
the
initiation
of
dosing
(
GD
6
9)
when
the
mid
and
high
dose
groups
had
a
net
weight
loss
compared
to
a
gain
by
the
controls.
The
high
dose
group
also
had
a
weight
loss
for
GD
9
12.
Weight
change
during
the
entire
dosing
interval
was
37%
of
the
control
level
for
the
mid
dose
group
and
a
weight
loss
of
12.2
g
by
the
high
dose
group.
Food
consumption
by
the
mid
and
high
dose
groups
was
significantly
(
73
and
47%,
respectively,
of
controls;
p
#
0.01)
less
than
the
controls
during
the
dosing
interval.
Weight
gain
and
food
consumption
by
the
mid
and
high
dose
dams
during
the
post
dosing
period
was
significantly
(
p
#
0.01)
greater
than
the
controls.
The
maternal
toxicity
LOAEL
is
established
at
80
mg/
kg/
day
based
on
decreased
body
weights,
body
weight
gains,
and
food
consumption.
The
maternal
toxicity
NOAEL
is
16
Diuron
RED
Toxicology
Chapter
11
mg/
kg/
day.
No
differences
were
observed
between
the
treated
and
control
groups
for
pregnancy
rate,
number
of
corpora
lutea,
number
of
implantation
sites,
number
of
fetuses/
litter,
or
fetal
sex
ratios.
No
dead
fetuses
or
late
resorptions
were
observed.
Two
high
dose
dams
had
total
litter
resorption
and
the
number
of
early
resorptions/
dam
in
the
high
dose
group
(
3.2)
was
slightly
greater
than
that
of
the
controls
(
1.2).
Mean
fetal
body
weight
in
the
high
dose
group
was
significantly
(
p
#
0.01;
91%
of
controls)
less
than
that
of
the
controls.
In
the
0,
16,
80,
and
400
mg/
kg/
day
groups,
the
total
number
of
fetuses(
litters)
examined
for
external
and
skeletal
malformations/
variations
was
288(
22),
306(
23),
297(
22),
and
279(
20),
respectively,
and
for
visceral
malformations/
variations
was
138(
22),
149(
23),
144(
22),
and
134(
20),
respectively.
No
treatment
related
external
or
visceral
malformations/
variations
were
observed
in
any
group.
Delayed
ossification
of
the
vertebrae
and
sternebrae
was
observed
in
fetuses
of
the
high
dose
group.
In
the
0,
16,
80,
and
400
mg/
kg/
day
groups
the
incidence
rates
for
litters
containing
fetuses
with
bifid
thoracic
vertebral
centra
was
1/
22,
1/
23,
2/
22,
and
7/
20
(
p
#
0.05),
respectively.
Incomplete
ossification
of
the
sternebrae
was
observed
in
fetuses
from
3/
22,
3/
23,
1/
22,
and
9/
20
(
p
#
0.05),
litters
respectively.
Unossified
thoracic
vertebral
centra
was
observed
in
fetuses
from
3/
20
(
p
#
0.05)
highdose
litters
but
not
in
fetuses
from
the
other
treated
or
control
groups.
The
developmental
toxicity
LOAEL
is
400
mg/
kg/
day
based
on
whole
litter
resorption,
reduced
fetal
body
weights,
and
delayed
ossification
of
the
vertebrae
and
sternebrae.
The
developmental
toxicity
NOAEL
is
80
mg/
kg/
day.
This
study
is
classified
as
unacceptable/
guideline
because
test
article
concentrations
in
the
mid
and
high
dose
solutions
were
highly
variable
and
well
outside
of
acceptable
ranges.
Also,
based
upon
available
analytical
data,
it
appears
that
target
doses
may
not
have
been
representative
of
the
actual
doses
to
the
animals.
In
addition,
the
lot
number
and
corresponding
analyses
were
not
provided.
However,
the
HIARC
determined
that
this
study
is
adequate
for
the
assessment
of
susceptibility
in
rats.
This
decision
was
made
based
on
the
fact
that
maternal
toxicity
was
seen
at
a
lower
dose
(
80
mg/
kg/
day)
compared
to
developmental
toxicity
(
400
mg/
kg/
day).
At
400
mg/
kg/
day,
developmental
effects
(
increased
incidence
of
early
resorption
and
decreased
fetal
body
weight)
were
seen
in
the
presence
of
maternal
toxicity
(
significantly
decreased
body
weight
gain
and
food
consumption).
The
HIARC
also
determined
that
a
repeat
of
this
study
is
not
required
since
the
effects
of
the
range
finding
study
showed
maternal
toxicity
(
decreased
body
weight
gain
and
food
consumption)
at
100,
200,
and
400
mg/
kg/
day
and
developmental
toxicity
(
increased
incidence
of
early
resorption
and
decreased
fetal
body
weight)
at
400
mg/
kg/
day.
Also,
the
rabbit
was
shown
to
be
the
more
susceptible
species
for
developmental
toxicity
study.
A
repeat
rat
study
would
not
provide
additional
data
for
risk
assessment/
risk
characterization
(
HIARC
Report,
HED
DOC.
No.
014657)
.
Diuron
RED
Toxicology
Chapter
12
870.3700b
Prenatal
Developmental
Toxicity
Study
Rabbit
EXECUTIVE
SUMMARY:
In
a
developmental
toxicity
study
(
MRID
40228802),
24
25
artificially
inseminated
New
Zealand
white
rabbits
per
group
were
administered
0,
2,
10,
or
50
mg/
kg/
day
of
Diuron
(
99%
a.
i.)
by
gavage
on
gestation
days
(
GD)
7
19,
inclusive.
On
GD
29,
all
surviving
does
were
sacrificed
and
examined
grossly.
One
control
animal
died
on
GD
0
due
to
an
anaphylactic
shock
reaction
during
insemination
and
one
high
dose
doe
aborted
and
was
killed
on
GD
26.
These
deaths
were
considered
unrelated
to
treatment.
All
remaining
animals
survived
to
scheduled
termination.
No
treatment
related
clinical
signs
of
toxicity
were
observed
in
any
animal.
Maternal
liver
weights
were
comparable
between
the
treated
and
control
groups
and
gross
necropsy
was
unremarkable.
Maternal
body
weights,
body
weight
gains,
and
food
consumption
for
the
low
and
mid
dose
groups
were
similar
to
the
control
levels
throughout
the
study.
Absolute
body
weights
of
the
high
dose
does
were
significantly
(
p
#
0.01)
less
than
the
controls
on
GD
20.
Mean
body
weight
gains
by
the
highdose
group
were
significantly
(
p
#
0.05
or
0.01)
reduced
as
compared
with
the
controls
during
the
intervals
of
GD
10
13,
13
16,
and
7
20
(
weight
loss).
Weight
gain
by
the
high
dose
group
was
significantly
(
p
#
0.05
or
0.01)
greater
than
the
controls
during
the
post
dosing
interval.
Food
consumption
by
the
high
dose
group
was
significantly
(
p
#
0.01)
less
than
the
controls
during
the
GD
13
16,
16
20
and
7
20
intervals.
The
maternal
toxicity
LOAEL
is
50
mg/
kg/
day
based
on
decreased
body
weights
and
food
consumption
during
the
dosing
interval.
The
maternal
toxicity
NOAEL
is
10
mg/
kg/
day.
At
cesarean
section,
the
pregnancy
rates,
numbers
of
corpora
lutea,
implantation
sites,
resorptions,
and
live
fetuses,
and
fetal
body
weights
were
similar
between
the
treated
and
control
groups.
No
dose
or
treatment
related
external,
visceral,
or
skeletal
malformations/
variations
were
observed
in
any
fetus.
The
developmental
toxicity
NOAEL
is
50
mg/
kg/
day
and
the
developmental
toxicity
LOAEL
is
not
identified.
This
study
is
classified
as
acceptable/
guideline
and
satisfy
the
guideline
requirements
for
a
developmental
toxicity
study
in
rabbits.
4.4
Reproductive
Toxicity
Adequacy
of
database
for
Reproductive
Toxicity:
The
database
for
reproductive
toxicity
is
Diuron
RED
Toxicology
Chapter
13
considered
adequate.
No
additional
studies
are
required
at
this
time.
There
is
no
reproductive
toxicity
observed.
870.3800
Reproduction
and
Fertility
Effects
Rat
EXECUTIVE
SUMMARY:
In
a
two
generation
reproduction
study
Diuron
(
97.1%
a.
i.,
Lot
No.
8805540)
was
administered
to
groups
of
30
male
and
30
female
Crl:
CD
®
BR
rats
in
the
diet
at
concentrations
of
0,
10,
250,
or
1750
ppm
(
MRID
41957301).
One
litter
was
produced
by
each
generation.
Overall
test
substance
intake
for
the
treated
F0
groups
was
0.58,
14.8,
and
101
mg/
kg/
day,
respectively,
for
males
and
0.71,
18.5,
and
131
mg/
kg/
day,
respectively,
for
females.
Test
substance
intake
for
the
treated
F1
groups
was
0.77,
18.9,
and
139
mg/
kg/
day,
respectively,
for
males
and
0.8,
22.1,
and
157
mg/
kg/
day,
respectively,
for
females.
F0
and
F1
parental
animals
were
administered
test
or
control
diet
for
73
or
105
days,
respectively,
prior
to
mating
and
throughout
mating,
gestation,
and
lactation,
and
until
necropsy.
Deaths
or
premature
sacrifices
of
several
F0
and
F1
parental
animals
were
considered
incidental
to
treatment.
No
treatment
related
clinical
signs
of
toxicity
were
observed
in
the
adult
animals
of
either
generation.
Gross
necropsy
was
unremarkable
and
testes
weights
were
not
affected
by
treatment.
For
the
low
and
mid
dose
groups
of
both
generations,
occasional
significant
differences
from
the
control
group
for
body
weights,
body
weight
gains,
food
consumption,
and
food
efficiencies
were
considered
incidental
to
treatment.
Body
weights
of
the
high
dose
F0
males
and
females
were
significantly
(
p
#
0.05)
decreased
by
an
average
of
7%
beginning
on
day
7.
Body
weight
gains
by
the
high
dose
F0
males
were
significantly
(
p
#
0.05)
less
than
the
control
group
on
days
0
14,
21
28,
42
49,
77
84,
and
91
98.
Premating,
postmating
and
overall
(
entire
study)
body
weight
gains
by
the
F0
males
were
significantly
(
p
#
0.05)
decreased
by
16%,
28%,
and
18%,
respectively,
compared
with
the
controls.
Body
weight
gains
by
the
high
dose
F0
females
were
significantly
(
p
#
0.05)
less
than
the
control
group
on
days
0
14
and
21
28
with
overall
premating
body
weight
gains
significantly
(
p
#
0.05)
decreased
by
28%
compared
with
the
controls.
Significant
(
p
#
0.05)
reductions
in
food
consumption
were
observed
in
the
high
dose
F0
males
and
females
on
days
0
14,
21
28,
35
49
(
females),
42
56
(
males),
and
0
70.
Food
efficiencies
for
the
F0
males
and
females
were
significantly
(
p
#
0.05)
reduced
at
similar
intervals
to
food
consumption
with
overall
premating
food
efficiency
reduced
by
8.3%
and
22.7%,
respectively.
Body
weights
of
the
high
dose
F1
males
and
females
were
significantly
(
p
#
0.05)
decreased
by
an
average
of
16%
beginning
on
day
0
of
premating.
Body
weight
gains
by
the
high
dose
F1
males
were
significantly
(
p
#
0.05)
less
than
the
control
group
on
days
0
28,
42
49,
63
70,
91
98,
and
147
154.
Premating,
post
mating,
and
overall
(
entire
study)
body
weight
gains
by
the
F1
males
were
significantly
(
p
#
0.05)
decreased
by
15%,
41%,
and
17%,
respectively,
compared
with
the
controls.
Body
weight
Diuron
RED
Toxicology
Chapter
14
gains
by
the
high
dose
F1
females
were
significantly
(
p
#
0.05)
less
than
the
control
group
on
days
0
14
with
overall
premating
body
weight
gains
significantly
(
p
#
0.05)
decreased
by
14%
compared
with
the
controls.
Significant
(
p
#
0.05)
reductions
in
food
consumption
were
observed
in
the
high
dose
F0
males
and
females
throughout
premating
with
the
exception
of
days
77
84
for
males.
Food
efficiencies
were
significantly
(
p
#
0.05)
reduced
for
the
high
dose
F1
males
on
days
91
98
and
for
the
high
dose
F1
females
on
days
0
7,
21
28,
and
0
70.
The
systemic
toxicity
LOAEL
is
1750
ppm
(
approximately
132
mg/
kg/
day)
based
on
reduced
body
weight,
body
weight
gain,
food
consumption,
and
food
efficiency
during
both
generations.
The
systemic
toxicity
NOAEL
is
250
ppm
(
approximately
18.6
mg/
kg/
day).
For
the
F0
and
F1
females,
reduced
body
weights
and
food
consumption
during
gestation
were
considered
a
continuation
of
premating
effects.
No
treatment
related
effects
were
noted
in
either
generation
on
fertility
indices,
gestation
length,
pup
survival,
pup
clinical
observations,
and
pup
anomalies.
Pup
body
weights
for
sexes
combined
or
separate
were
significantly
(
p
#
0.05)
reduced
in
high
dose
litters
as
compared
with
the
controls
throughout
lactation
for
the
F1
pups
and
beginning
on
lactation
day
7
for
the
F2
pups.
The
offspring
toxicity
LOAEL
is
1750
ppm
(
approximately
132
mg/
kg/
day)
based
on
decreased
body
weights
of
the
F1
and
F2
pups
during
lactation.
The
offspring
toxicity
NOAEL
is
250
ppm
(
18.6
mg/
kg/
day).
The
reproductive
toxicity
NOAEL
is
1750
ppm
(
132
mg/
kg/
day)
(
HDT).
This
study
is
classified
as
acceptable/
guideline
and
satisfies
the
guideline
requirements
for
a
reproductive
toxicity
study
in
rats.
4.5
Chronic
Toxicity
Adequacy
of
database
for
chronic
toxicity:
The
database
for
chronic
toxicity
is
considered
adequate.
No
additional
studies
are
required
at
this
time.
A
two
year
chronic
toxicity
study
in
dogs
was
classified
as
unacceptable/
guideline
based
on
deficiences
in
analytical
data
for
dietary
analysis.
However,
the
HIARC
determined
that
a
repeated
chronic
dog
study
is
not
required
because
a
new
study
would
not
provide
additional
data
since
the
observed
effects
are
similar
in
the
rat
and
the
rat
is
the
more
sensitive
species
for
this
chemical
(
HIARC
Report,
HED
Doc.
No.
14657).
870.4300
Combined
Chronic
Toxicity/
Carcinogenicity
Rat
Diuron
RED
Toxicology
Chapter
15
EXECUTIVE
SUMMARY:
In
a
chronic
toxicity/
oncogenicity
study
(
MRID
40886501;
supplementary
data
provided
in
MRIDs
43871901,
43804501,
and
44302003),
diuron
(
98.7%
a.
i.;
batch
no.
232114080)
was
administered
to
groups
of
60
male
and
60
female
Wistar
rats
at
dietary
concentrations
of
0,
25,
250,
or
2500
ppm
(
0,
1.0,
10,
or
111
mg/
kg/
day,
respectively,
for
males
and
0,
1.7,
17,
or
203
mg/
kg/
day
for
females,
respectively)
for
up
to
24
months.
At
12
months,
10
animals/
sex/
group
were
sacrificed
for
interim
evaluation.
Treatment
with
diuron
did
not
affect
the
survival
of
rats.
The
only
reported
treatment
related
clinical
sign
was
reddish
discolored
or
bloody
urine
in
some
high
dose
males.
A
significant
decrease
in
body
weight
was
seen
in
both
sexes
of
high
dose
rats
(
12
15%
for
males;
6
14%
for
females,
p<
0.01)
throughout
the
study.
Body
weight
gains
were
similarly
depressed,
the
total
gains
for
high
dose
males
and
females
were
82
and
79%
of
controls,
respectively.
The
slight
decreases
in
body
weights
and
weight
gains
of
mid
dose
males
(
4
6%;
p<
0.05
or
0.01)
were
not
biologically
significant.
Food
consumption
was
unaffected
but
overall
food
efficiency
was
lowered
for
high
dose
males
and
females
(
86%
and
76%
of
controls,
respectively).
The
hematopoietic
system
and
urinary
bladder
(
and
renal
pelvis)
were
the
primary
diuron
target
organs.
Erythrocyte
damage
resulted
in
hemolytic
anemia
and
compensatory
hematopoiesis,
which
were
manifested
as
significantly
decreased
(
p<
0.05
or
0.01)
erythrocyte
counts,
hemoglobin
levels,
and
hematocrit
and
increased
MCV,
MCH,
abnormal
erythrocyte
forms,
reticulocyte
counts,
and
leukocyte
counts
(
with
no
effect
on
differential
counts)
in
mid
and/
or
high
dose
males
and
females,
and
in
lowdose
females
(
#
25%
change
for
most
parameters;
3
fold
increase
for
reticulocytes).
Hemolysis
also
led
to
increased
(
39
50%)
plasma
bilirubin
in
high
dose
males
and
females.
Consistent
with
erythrocyte
damage,
post
mortem
gross
examination
showed
a
dose
related
increase
(
18
220%)
in
spleen
weight
(
absolute
and
relative
to
body)
for
all
test
groups
at
12
and/
or
24
months,
and
an
increased
incidence
of
spleen
dark
discoloration
and/
or
swelling
in
mid
and
high
dose
males
and
females
after
12
and/
or
24
months.
Morphometric
analysis
of
spleen
sections
to
determine
the
percentage
area
of
hemosiderin
revealed
an
increase
at
$
250
ppm
in
both
sexes
at
12
months
and
in
all
groups
at
24
months
(
p<
0.05
or
0.01),
with
the
females
being
affected
more
severely.
The
chronic
overburden
of
spleen
function
led
to
an
increased
incidence
of
spleen
fibrosis
in
2500
ppm
males
and
females
(
p<
0.01).
Bone
marrow
activation
occurred
in
both
sexes
at
all
test
doses
at
24
months
(
p<
0.05
or
0.01
for
all
but
low
dose
females).
This
was
evident
morphometrically
as
an
increase
in
hematopoietic
(
red)
bone
marrow
for
mid
and
high
dose
rats
at
12
and/
or
24
months
(
possibly
in
lowdose
males
at
12
months)
with
a
concomitant
decrease
in
fat
marrow
at
12
months
(
not
evaluated
at
24
months).
Gross
pathology
showed
that
the
incidence
of
urinary
bladder
wall
thickening
was
elevated
at
24
months
for
low
and
high
dose
males
and
high
dose
females
(
p<
0.05
or
0.01).
Microscopic
evaluation
showed
that
epithelial
focal
hyperplasia
of
the
urinary
tract
and
renal
pelvis
increased
in
severity
in
both
sexes
at
12
and/
or
24
months,
and
increased
in
incidence
(
p<
0.01)
in
high
dose
males
Diuron
RED
Toxicology
Chapter
16
at
12
months
and
in
high
dose
females
at
12
and/
or
24
months
with
mid
dose
females
showing
an
increased
incidence
at
24
months.
Some
gross
and/
or
microscopic
changes
were
also
seen
in
the
liver
(
increased
weight,
swelling,
discoloration,
vacuolar
cell
degeneration,
round
cell
infiltration,
hyperemia)
although
these
effects
were
not
clearly
primary
effects
of
treatment.
Under
the
conditions
of
this
study,
the
LOAEL
is
25
ppm
for
both
sexes
of
rats
(
1.0
and
1.7
mg/
kg/
day
for
males
and
females,
respectively)
based
on
evidence
of
hemolysis
and
compensatory
hematopoiesis
(
decreased
erythrocyte
count,
increased
reticulocyte
counts,
increased
spleen
weight
and
bone
marrow
activation).
A
NOAEL
is
not
established.
This
study
showed
conclusive
evidence
for
the
carcinogenicity
of
Diuron
in
male
and
female
rats.
The
incidence
of
urinary
bladder
carcinoma
was
increased
at
2500
ppm
in
both
sexes
(
males:
33/
49
vs.
1/
50
for
controls;
females:
11/
50
vs.
0/
48
for
controls;
p<
0.01).
The
malignancies
were
usually
characterized
as
transitional
epithelial
carcinomas.
The
slight
increase
(
NS)
in
the
incidence
of
urinary
bladder
papilloma
and
the
3
neoplasms
in
the
renal
pelvis
in
high
dose
males
(
one
papilloma
and
two
carcinomas)
were
also
considered
treatment
related.
Dosing
was
adequate
based
on
numerous
toxic
effects
(
hematological,
microscopic,
etc.)
observed
in
the
animals
at
all
tested
doses.
This
chronic
toxicity
/
carcinogenicity
study,
together
with
the
subsequently
submitted
supplementary
materials,
is
acceptable/
guideline
and
does
satisfy
the
guideline
requirement
for
a
chronic
toxicity/
oncogenicity
oral
study
in
the
rat.
There
were
some
noted
deficiencies
but
none
that
would
invalidate
the
study.
870.4100b
Chronic
Toxicity
Dog
EXECUTIVE
SUMMARY:
In
a
24
month
dietary
toxicity
study
(
MRID
00091192),
groups
of
three
male
and
three
female
beagle
dogs
were
given
Diuron
(
80%
purity;
initial
lot
number
not
reported,
second
quantity
coded
T
7111
3D)
administered
in
feed
at
0,
25,
125,
250,
or
2500/
1250
ppm
(
0,
1.8,
9.4,
18.8,
or
93.8
mg/
kg/
day
by
conversion
factor
of
0.075).
The
high
dose
group
received
a
diet
containing
2500
ppm
of
the
test
material
for
two
weeks,
then
received
only
the
basal
diet
for
a
three
week
reconditioning
period,
then
received
a
diet
containing
1250
ppm
of
the
test
material
for
the
remainder
of
the
two
year
study.
There
were
no
treatment
related
deaths
and
aside
from
occasional
partial
food
refusal
at
the
highest
dietary
concentration,
there
were
no
treatment
related
clinical
signs.
Adverse
effects
of
treatment
on
body
weight
included
an
overall
day
0
735
body
weight
losses
at
the
2500/
1250
ppm
dietary
concentration
by
both
males
(
18%
loss
of
the
pre
treatment
weight
vs
a
15%
body
weight
gain
by
controls)
and
females
(
13%
loss
of
the
pretreatment
weight
vs
a
15%
body
weight
gain
by
controls)
and
decreased
day
0
364
body
weight
gains
by
males
at
the
250
ppm
dietary
concentration
(
44%
of
Diuron
RED
Toxicology
Chapter
17
controls).
At
the
2500/
1250
ppm
dietary
concentration,
normocytic
to
macrocytic,
normochromic
anemia
was
noted
in
males
on
days
225
720
and
in
females
at
all
time
points
starting
at
week
2,
and
the
observation
of
brown
pigment
(
likely
hemosiderin)
observed
in
Kupffer
cells
of
all
high
dose
animals
is
suggestive
of
hemolysis.
At
the
highest
dietary
concentration,
increased
numbers
of
erythroid
precursors/
1000
bone
marrow
progenitor
cells
for
male
and
female
dogs
(
520
vs.
352
for
controls),
and
moderately
reduced
marrow
fat
[
implying
hypercellularity]
in
histopathological
preparations
are
consistent
with
attempts
at
erythrocytic
regeneration.
At
the
highest
dietary
concentration,
absolute
and
relative
liver
weights
were
increased
in
both
males
(
22
and
54%
greater
than
controls)
and
females
(
35
and
62%
greater
than
controls),
and
liver
to
brain
weight
ratios
were
increased
in
both
sexes
(
25
and
23%
for
males
and
females,
respectively).
There
were
no
other
gross
or
histopathological
hepatic
changes,
and
clinical
chemistry
parameters
were
not
evaluated.
Although
the
increased
liver
weights
may
be
associated
with
erythrocyte
sequestration,
a
hepatotoxic
treatment
related
effect
cannot
be
definitely
ruled
out.
Under
the
conditions
of
this
study,
the
LOAEL
for
Diuron
in
male
Beagle
dogs
is
250
ppm
(
18.8
mg/
kg/
day),
based
on
decreased
body
weight
gains,
and
the
LOAEL
in
female
Beagle
dogs
is
1250
ppm
(
93.8
mg/
kg/
day),
based
on
a
normocytic
to
macrocytic,
normochromic
anemia
and
body
weight
losses.
The
NOAEL
is
125
ppm
(
9.4
mg/
kg/
day)
in
males
and
250
ppm
(
18.8
mg/
kg/
day)
in
females.
This
study
is
classified
as
unacceptable/
guideline
and
does
not
satisfy
the
Subdivision
F
guideline
requirements.
The
exact
dietary
concentrations
administered
to
the
animals
is
unknown,
due
to
the
following
deficiencies:
1)
the
test
material
purity
was
80%
and
it
is
unknown
whether
the
amount
of
test
material
used
in
diet
preparation
was
adjusted
to
account
for
this;
2)
stability,
homogeneity,
and
concentration
of
the
test
material
in
food
were
not
determined
prior
to
study
initiation;
and
3)
the
physical
properties
(
including
stability)
of
the
test
substance
were
not
provided.
However,
after
reviewing
the
toxicity
database
of
diuron,
the
HIARC
determined
that
a
repeated
chronic
dog
study
is
not
required
because
a
new
study
would
not
provide
additional
data
since
the
observed
effects
are
similar
in
the
rat
and
the
rat
is
the
more
sensitive
species
for
this
chemical
(
HIARC
Report,
HED
DOC.
No.
014657).
4.6
Carcinogenicity
Adequacy
of
database
for
Carcinogenicity:
The
database
for
carcinogenicity
is
considered
adequate.
No
additional
studies
are
required
at
this
time.
The
HED
Carcinogenicity
Peer
Review
Committee
(
CPRC)
met
on
December
18,
1996
and
classified
diuron
as
a
"
known/
likely"
human
carcinogen
based
on
urinary
bladder
carcinoma
in
both
sexes
of
the
Wistar
rat,
kidney
carcinomas
in
the
male
rat
(
a
rare
tumor),
and
mammary
gland
carcinomas
in
the
female
NMRI
mouse.
The
CPRC
Diuron
RED
Toxicology
Chapter
18
also
recommended
a
low
dose
linear
extrapolation
model
with
Q1
*
of
1.91x10
2
(
mg/
kg/
day)
1
be
applied
to
the
animal
data
for
the
quantification
of
human
risk,
based
on
the
urinary
bladder
carcinomas
in
the
rat.
The
HED
Mechanism
of
Toxicity
Assessment
Review
Committee
(
MTARC)
has
evaluated
a
proposed
mode
of
action
submitted
by
the
Registrant
and
concluded
that
the
submitted
information
is
insufficient
to
support
a
mode
of
action
on
bladder
carcinogenicity
for
diuron.
Diuron
will
not
be
re
classified
at
this
time.
870.4300
Combined
Chronic
Toxicity/
Carcinogenicity
Rat
See
executive
summary
above.
870.4200b
Carcinogenicity
(
feeding)
Mouse
EXECUTIVE
SUMMARY:
In
a
carcinogenicity
study
(
MRID
42159501),
Diuron
(
98.7%
a.
i.,
batch
no.
232114080)
was
administered
to
groups
of
60
male
and
60
female
NMRI
(
SPF
HAN)
mice
in
the
diet
at
concentrations
of
0,
25,
250,
or
2500
ppm.
The
test
diets
were
given
for
24
months
except
for
10
mice/
sex/
group
which
were
sacrificed
after
12
months
for
an
interim
study.
The
concentrations
of
25,
250,
and
2500
ppm
resulted
in
mean
daily
compound
intakes
for
males
of
5.4,
50.8,
or
640.13
mg/
kg/
day;
and
for
females
of
7.5,
77.5,
or
867.0
mg/
kg/
day,
respectively.
A
supplementary
document
(
MRID
43349301)
provided
additional
summary
data
from
the
original
study
on
body
weight
gain,
food
efficiency,
macroscopic
findings
at
12
months,
ovarian
and
mammary
gland
tumors;
and
also
provided
historical
control
tumor
frequencies.
No
significant
treatment
related
effects
were
seen
in
clinical
signs
or
survival.
Body
weights
after
78
weeks
of
treatment
were
7%
(
p
#
0.01)
and
4%
(
NS)
less
than
the
controls
for
high
dose
males
and
females,
respectively;
and
cumulative
body
weight
gains
were
21%
and
12%
less
than
the
controls
at
78
weeks.
The
overall
food
intake
was
about
17%
greater
for
high
dose
males
and
12%
greater
for
high
dose
females
than
the
controls.
Food
efficiency
for
the
2
year
study
was
decreased
in
high
dose
males
and
females
by
21
22%
compared
to
the
controls.
Small,
but
statistically
significant
increases
of
4
10%
in
group
mean
erythrocyte
cell
volume
and
mean
cell
hemoglobin
were
seen
in
males
and
females
at
various
times
during
the
study.
Reticulocyte
counts
were
increased
in
high
dose
males
by
9
62%
and
in
females
by
24
63%
compared
to
the
controls.
These
hematology
changes
were
accompanied
by
increased
absolute
and
relative
(
to
body)
spleen
weights,
increased
serum
bilirubin,
and
increased
iron
deposits
(
hemosiderin)
in
the
spleens
of
highdose
males
and
females.
These
observations
are
consistent
with
a
treatment
related
compensated
hemolytic
anemia
at
2500
ppm.
Total
leukocyte
counts
were
increased
by
48%
and
51%
(
p
#
0.01)
in
high
dose
males
and
females,
respectively,
at
18
months
and
by
95%
(
p
#
0.01)
in
high
dose
females
at
Diuron
RED
Toxicology
Chapter
19
24
months.
Differential
counts
were
within
normal
parameters
for
both
sexes
at
all
doses.
Serum
alanine
aminotransferase
activity
was
increased
by
95%
in
males
and
by
66%
in
females
at
2500
ppm
compared
to
the
controls
after
24
and
6
months
of
treatment,
respectively.
The
absolute
and
relative
(
to
body)
liver
weights
were
increased
by
9%
and
11
%,
respectively
in
high
dose
males
at
24
months
compared
to
the
control.
Microscopic
evidence
of
liver
toxicity
at
2500
ppm
included
increased
incidences
of
increased
mitosis
in
both
sexes,
centrilobular
hypertrophy
in
males,
Kupffer
cell
clusters
in
males,
enlarged/
degenerative
liver
cells
in
females,
and
single
cell
necroses
in
females.
Increased
incidences
of
urinary
bladder
edema,
thickened
mucosa,
and
epithelia
hyperplasia
were
seen
in
high
dose
females
after
24
months
of
treatment
compared
to
the
control.
The
epithelia
hyperplasia
incidence
was
increased
after
12
months
in
high
dose
females.
There
was
also
an
increased
incidence
of
uterine
horn
diameters
measuring
greater
than
2
mm
in
females
at
2500
ppm,
but
no
adverse
microscopic
findings
were
noted.
The
LOAEL
is
2500
ppm
in
the
diet
for
males
(
640.13
mg/
kg/
day)
and
females
(
867.0
mg/
kg/
day),
based
on
hemolytic
anemia
and
liver
toxicity
in
both
sexes,
and
urinary
bladder
toxicity
in
females.
The
NOAEL
is
250
ppm
for
males
(
50.8
mg/
kg/
day)
and
females
(
77.5
mg/
kg/
day).
Treatment
of
up
to
102
weeks
with
2500
ppm
Diuron
resulted
in
a
significant
increase
in
the
incidences
of
mammary
adenocarcinomas
(
control,
4%;
2500
ppm,
12%,
p
#
0.05)
and
ovarian
luteomas
(
control,
6%;
2500
ppm,
14%,
p
#
0.01)
in
female
NMRI
(
SPF
HAN)
mice
under
the
conditions
of
this
study.
However,
the
incidence
of
mammary
adenocarcinoma
in
high
dose
females
was
at
or
near
the
high
range
of
incidences
seen
in
historic
controls.
On
December
18,
1996
the
Carcinogenicity
Peer
review
Committee
(
CPRC)
determined
that
the
female
mouse
ovarian
tumor
rates
table
should
reflect
the
more
appropriate
'
combined
sex
cordstromal
tumors'
nomenclature
in
lieu
of
the
"
luteoma"
terminology
used
in
the
qualitative
risk
assessment
(
Lori
L.
Brunsman
to
Linda
L.
Taylor,
11/
20/
96).
Dr.
Lucas
Brennecke,
EPA's
consulting
pathologist,
confirmed
that
the
combined
tumor
counts
are
more
appropriate
than
the
individual
counts
for
ovarian
tumors,
as
it
is
difficult
to
distinguish
between
the
different
types
of
ovarian
tumors.
The
CPRC
concluded
that
female
mice
do
not
have
a
significant
increasing
trend,
or
any
significant
differences
in
the
pair
wise
comparisons
of
the
dosed
groups
with
the
controls,
for
ovarian
combined
sex
cordstromal
tumors.
This
carcinogenicity
study
in
the
mouse
is
acceptable/
guideline
and
does
satisfy
the
guideline
requirement
for
an
oncogenicity
study
in
mice.
Diuron
RED
Toxicology
Chapter
20
4.7
Mutagenicity
Adequacy
of
database
for
Mutagenicity:
The
database
for
mutagenicity
is
considered
adequate.
Diuron
was
not
mutagenic
in
bacteria
or
in
cultured
mammalian
cells
and
no
indication
of
DNA
damage
in
primary
rat
hepatocytes
was
observed.
There
were
marginal
statistically
increases
in
cells
with
structural
aberrations
in
Sprague
Dawley
rats
in
vivo
bone
marrow
chromosomal
aberration
assay.
However,
the
levels
of
aberrations
were
within
the
historical
control
range
and
assessed
negative.
In
addition,
there
is
no
eveidence
of
a
clastogenic
effect
of
diuron
in
an
in
vivo
mouse
micronucleus
test.
Gene
Mutation
Guideline
870.5100
Gene
mutation:
Salmonella
typhimurium
reverse
gene
mutation
MRID
00146608/
40228805
Acceptable/
Guideline
Independent
trials
were
negative
in
S.
typhimurium
strains
TA1535,
TA97,
TA98
and
TA100
up
to
the
highest
dose
tested
(
10
µ
g/
plate
S9;
250
µ
g/
plate
+
S9);
higher
concentrations
(
$
50
µ
g/
plate
S9;
500
µ
g/
plate
+
S9)
were
cytotoxic.
Guideline
870.5300
Gene
mutation
Chinese
Hamster
Ovary
(
CHO)/
HGPRT
cell
forward
gene
mutation
assay
MRID
00146609
Acceptable/
Guideline
Independent
tests
were
negative
up
to
cytotoxic
doses
without
S9
activation
(
1.250
mM,
.
291
µ
g/
mL)
and
with
S9
activation
(
0.5
mM
,
.
117
µ
g/
mL).
Cytogenetics
Guideline
870.5385
Chromosomal
aberration
In
vivo
bone
marrow
cytogenetic
assay
MRID
00146611
MRID
44350301
(
revised)
Acceptable/
Guideline
The
test
was
negative
in
male
Sprague
Dawley
rats
administered
0,
50,
500
or
5000
mg/
kg/
day
by
single
oral
gavage.
Signs
of
overt
toxicity
(
mortality,
body
weight
loss,
ocular
discharge,
depression,
labored
respiration,
diarrhea,
and
tremors)
were
noted
at
5000
mg/
kg.
Cytotoxicity
to
the
target
organ
as
indicated
by
the
significantly
decreased
(
p
#
0.01)
mitotic
indices
at
24
and
48
hours
for
high
dose
males;
data
combined
for
both
sexes
were
also
significantly
decreased
at
24
hours.
A
significant
(
p<
0.05)
increase
in
the
percentage
of
abnormal
cells
and
the
average
number
of
aberrations
per
cell
was
seen
but
only
when
the
data
were
combined
for
the
high
and
mid
dose
males
and
females
at
the
48
hour
sampling
time.
Values
were
0.6
and
0.9
%
(
combined
percentage
abnormal
cells)
at
500
and
5000
mg/
kg,
respectively
and
0.008
and
0.009
(
combined
number
of
aberrations/
cell)
at
500
and
5000
mg/
kg,
respectively.
A
significant
positive
linear
trend
was
also
recorded
for
the
combined
(
by
sex)
aberrations
per
cell
and
percentage
abnormal
cells.
Nevertheless,
the
values
fell
well
within
the
range
of
historical
control
[
percent
abnormal
cells/
group:
0
2.6%
(
%
)
and
0
2.0%
(
&
)
;
average
number
of
aberrations/
cell:
0
0.023%
(
%
)
and
0
0.060
%
(
&
)
].
Guideline
870.5385
Chromosomal
aberration
In
vivo
bone
marrow
cytogenetic
assay
MRID
45494505
Acceptable/
Guideline
The
test
was
negative
in
male
and
female
Hsd/
Win:
NMRI
mice
administered
0
or
700
mg/
kg
by
a
single
intraperitoneal
injection.
Signs
of
overt
toxicity
(
apathy,
roughened
flur,
staggering
gait,
sternal
recumbency,
spasm,
twitching,
difficulty
in
breathing
and
eyelids
stuck
together)
were
seen
at
700
mg/
kg.
No
compound
related
mortality
was
seen.
There
is
no
evidence
of
clastogenic
effect
of
diuron.
Other
Genotoxicity
Diuron
RED
Toxicology
Chapter
21
Guideline
870.5550
Unscheduled
DNA
Synthesis
MRID
00146610
Acceptable/
Guideline
The
test
was
negative
up
to
cytotoxic
doses
(
$
0.33
mM,
equivalent
to
.
76
F
g/
mL).
4.8
Neurotoxicity
Adequacy
of
database
for
Neurotoxicity:
No
acute
or
subchronic
neurotoxicity
study
is
available.
There
are
no
neurotoxic
signs
in
any
of
the
subchronic
or
chronic
studies.
Literature
search
did
not
reveal
studies
relevant
for
assessing
the
potential
neurotoxicity.
870.6100
Delayed
Neurotoxicity
Study
Hen
Not
available
and
not
required
for
diuron
at
this
time.
870.6200
Acute
Neurotoxicity
Screening
Battery
Not
available
and
not
required
at
this
time.
870.6200
Subchronic
Neurotoxicity
Screening
Battery
Not
available
and
not
required
at
this
time.
870.6300
Developmental
Neurotoxicity
Study
Not
available
and
not
required
for
diuron
at
this
time.
4.9
Metabolism
Adequacy
of
database
for
metabolism:
The
database
for
metabolism
is
considered
adequate.
No
additional
studies
are
required
at
this
time.
870.7485
Metabolism
Rat
EXECUTIVE
SUMMARY:
In
a
metabolism
study
(
MRID
44019601)
in
rats,
14C
Diuron
[
radiolabel
>
98.3%;
>
95%
a.
i.]
was
administered
to
5
Sprague
Dawley
rats/
sex/
dose
as
(
1)
a
single
oral
high
[
400
mg/
kg]
dose,
(
2)
a
single
oral
low
[
10
mg/
kg]
dose,
or
(
3)
a
multiple
oral
low
dose
[
10
mg/
kg/
day]
of
unlabeled
Diuron
for
15
consecutive
days
followed
by
a
single
oral
low
[
10
mg/
kg]
dose
[
14C
Diuron].
The
objectives
of
this
study
were
to
determine
(
1)
the
Diuron
RED
Toxicology
Chapter
22
absorption/
distribution/
metabolism/
excretion
of
14C
Diuron
in
rats
following
single
or
multiple
dose
exposure,
(
2)
to
identify/
characterize,
and
to
the
extent
possible,
quantify
products
of
excreta,
and
(
3)
to
determine
any
possible
bioaccumulation
and/
or
bioretention
of
Diuron
and
its
metabolites.
Diuron
was
rapidly
absorbed
and
metabolized
following
all
dosing
regimens.
The
total
recovery
of
radioactivity
following
all
exposure
was
>
95%.
Greater
than
90%
of
the
administered
radiolabel
was
recovered
in
excreta
and
cage
wash
of
the
low
dose
groups
within
24
hours
postdose
and
within
48
hours
postdose
in
the
high
dose
group.
The
urine
was
the
major
route
of
excretion
for
all
groups
in
both
sexes.
A
slightly
higher
percent
of
the
dose
was
excreted
in
the
feces
following
the
single
high
dose
[
%
%
.
15%/
&
&
.
13%]
than
was
found
following
both
low
dose
exposures
[
%
%
9%
10%/
&
&
8%
9%].
The
highest
tissue
residue
levels
were
found
in
the
liver
and
kidneys
4
days
post
14C
Diuron
dose,
at
which
time
the
blood
levels
were
0.04%
0.08%
of
the
administered
dose.
The
major
urine
metabolite
in
both
sexes
following
all
dosing
regimens
was
IN
R915,
which
accounted
for
>
20%
of
the
total
administered
radiolabel.
Other
metabolites
were
glucuronide
conjugates
of
IN
U1232,
HO
Me
IND0432
IN
D0230,
IN
T1035,
and
sulfate
conjugate
of
IN
U1232
[
only
found
in
low
dose
groups],
and
free
metabolites
IN
U1232,
IN
JT680,
IN
T1035,
and
IN
KH289.
A
small
amount
of
Diuron
was
detected
in
the
feces
following
all
dosing
regimens.
Metabolism
of
Diuron
involved
N
oxidation,
ring
hydroxylation,
demethylation,
dechlorination,
and
conjugation
to
sulfate
and
glucuronic
acid.
Diuron
was
well
absorbed
following
all
exposure
regimens,
and
the
majority
of
the
radioactivity
was
eliminated
via
the
urine.
No
apparent
difference
was
observed
between
single
and
multiple
low
oral
doses.
There
was
no
apparent
sex
related
difference
in
either
absorption
or
elimination,
and
minimal
tissue
accumulation
was
observed.
This
metabolism
study
in
the
rat
is
classified
Acceptable/
guideline
and
does
satisfy
the
guideline
requirement
for
a
metabolism
study.
5.0
TOXICITY
ENDPOINT
SELECTION
5.1
See
Section
9.2
for
Endpoint
Selection
Table.
5.2
Dermal
Absorption
Dermal
Absorption
Factor:
4%
No
dermal
absorption
study
is
available
for
diuron
at
the
time
of
this
assessment.
A
dermal
absorption
factor
of
4%
for
diuron
was
extrapolated
using
the
maternal
toxicity
LOAEL
of
50
mg/
kg/
day
from
a
developmental
toxicity
study
in
the
rabbit
and
the
NOAEL
of
1200
mg/
kg/
day
from
a
21
day
dermal
toxicity
study
in
the
rabbit:
the
ratio
is
50/
1200
or
4%
(
HIARC
Report,
HED
DOC.
No.
014657).
Diuron
RED
Toxicology
Chapter
23
5.3
Classification
of
Carcinogenic
Potential
5.3.1
Conclusions
Treatment
of
diuron
resulted
in
a
significant
increase
in
the
incidences
of
urinary
bladder
carcinoma
in
both
sexes
of
the
Wistar
rat,
kidney
carcinomas
in
the
male
rat
(
a
rare
tumor),
and
mammary
gland
carcinomas
in
the
female
NMRI
mouse.
There
are
no
acceptable
modes
of
action
on
mechanism
of
carcinogenicity
for
diuron.
5.3.2
Classification
of
Carcinogenic
Potential
The
HED
Carcinogenicity
Peer
Review
Committee
(
CPRC)
classified
diuron
as
"
known/
likely"
human
carcinogen.
5.3.3
Quantification
of
Carcinogenic
Potential
The
CPRC
recommended
a
low
dose
linear
extrapolation
model
with
Q1
*
of
1.91x10
2
(
mg/
kg/
day)
1
be
applied
to
the
animal
data
for
the
quantification
of
human
risk,
based
on
the
urinary
bladder
carcinomas
in
the
male
rat.
6.0
FQPA
CONSIDERATIONS
6.1
Special
Sensitivity
to
Infants
and
Children
Base
on
the
developmental
and
reproductive
toxicity
studies,
there
was
no
evidence
(
qualitative
or
quantitative)
for
increased
susceptibility
following
in
utero
and/
or
pre/
post
natal
exposure.
6.2
Recommendation
for
a
Developmental
Neurotoxicity
Study
There
is
no
evidence
to
suggest
requiring
a
developmental
neurotoxicity
study.
The
developmental
toxicity
studies
in
rats
and
rabbits
as
well
as
the
reproductive
toxicity
study
in
rats
did
not
show
any
adverse
effects
below
maternal
or
parental
doses.
7.0
OTHER
ISSUES
None.
8.0
REFERENCES
Diuron
RED
Toxicology
Chapter
24
00091192
Hodge,
H.
C.;
Downs,
W.
L.;
Maynard,
E.
A.;
et
al.
(
1964)
Chronic
Feeding
Studies
of
Diuron
in
Dogs.
(
Unpublished
study
received
Aug
8,
1964
under
5F0432;
prepared
by
Univ.
of
Rochester,
Dept.
of
Pharmacology,
submitted
by
E.
I.
du
Pont
de
Nemours
&
Co.,
Inc.,
Wilmington,
Del.;
CDL:
090468
B)
00146144
Rosenfeld,
G.
(
1985)
Acute
Oral
Toxicity
Study
in
Rats.
Diurex
Tech
(
Diuron):
Study
#
1222A.
Unpublished
study
prepared
by
Cosmopolitan
Safety
Evaluation,
Inc.
28
p.
00146146
Rosenfeld,
G.
(
1985)
Acute
Dermal
Toxicity
Study
in
Rabbits.
Diurex
Tech
(
Diuron):
Study
#
1222B.
Unpublished
study
prepared
by
Cosmopolitan
Safety
Evaluation,
Inc.
18
p.
00146147
Rosenfeld,
G.
(
1985)
Primary
Eye
Irritation
Study
in
Rabbits.
Diurex
Technical
(
Diuron):
Study
#
1222D.
Unpublished
study
prepared
by
Cosmopolitan
Safety
Evaluation,
Inc.
17
p.
00146148
Rosenfeld,
G.
(
1985)
Primary
Dermal
Irritation
Study
in
Rabbits
Diurex
Tech
(
Diuron):
Study
#
1222E.
Unpublished
study
prepared
by
Cosmopolitan
Safety
Evaluation,
Inc.
14
p.
00146149
Rosenfeld,
G.
(
1985)
Guinea
Pig
Sensitization
Study
(
Buehler).
Diurex
Tech
(
Diuron):
Study
#
1222F.
Unpublished
study
prepared
by
Cosmopolitan
Safety
Evaluation,
Inc.
16
p.
00146611
Ullman,
D.
(
1985)
In
vivo
Assay
of
Diuron
for
Chromosome
Aberrations
in
Rat
Bone
Marrow
Cells:
Report
No.
366
85.
Unpublished
study
prepared
by
E.
I.
du
Pont
de
Nemours
&
Co.,
Inc.
22
p.
00146608
Poet,
L.
(
1985)
Mutagenicity
Evaluation
in
Salmonella
typhimurium:
Diuron:
Report
No.
471
84.
Unpublished
study
prepared
by
E.
I.
du
Pont
de
Nemours
&
Co.,
Inc.
17
p.
00146609
Rickard,
L.
(
1985)
Mutagenicity
Evaluation
of
Diuron
in
the
CHO/
HGPRT
Assay:
Chinese
Hamster
Ovary
(
CHO)
Cells:
Report
No.
282
85.
Unpublished
study
prepared
by
E.
I.
du
Pont
de
Nemours
&
Co.,
Inc.
17
p.
00146610
Arce,
G.
(
1985)
Assessment
of
Diuron
in
the
in
vitro
Unscheduled
DNA
Synthesis
Assay
in
Primary
Rat
Hepatocytes:
Report
No.
349
85.
Unpublished
study
prepared
by
E.
I.
du
Pont
de
Nemours
&
Co.,
Inc.
18
p.
40228801
Dearlove,
G.
(
1986)
Developmental
Toxicity
Study
of
H
16035
(
Diuron)
Administered
by
Gavage
to
Rats:
Haskell
Laboratory
Report
No.
HLO
410
86.
Unpublished
study
prepared
by
Argus
Research
Laboratories,
Inc.
240
p.
40228802
Dearlove,
G.
(
1986)
Developmental
Toxicity
Study
of
H
16035
(
Diuron)
Administered
by
Gavage
to
New
Zealand
White
Rabbits:
Haskell
Laboratory
Report
No.
HLO
332
86.
Unpublished
study
prepared
by
Argus
Research
Laboratories,
Inc.
242
p.
41957301
Cook,
J.
(
1990)
40228803
Kinney,
L.
(
1987)
Acute
Inhalation
Toxicity
Study
with
Diuron
in
Rats:
Haskell
Laboratory
Report
No.
101
87:
Medical
Research
No.
4581
432.
Unpublished
study
prepared
by
E.
I.
du
Pont
de
Nemours
&
Co.,
Inc.,
Haskell
Laboratory
for
Toxicology
Diuron
RED
Toxicology
Chapter
25
and
Industrial
Medicine.
22
p.
40228805
Arce,
G.
(
1984)
Mutagenicity
Evaluation
(
of
Diuron)
in
Salmonella
Typhimurium:
Haskell
Laboratory
Report
No.
HLR
471
84.
Unpublished
study
prepared
by
E.
I.
du
Pont
de
Nemours
&
Co.,
Inc.,
Haskell
Laboratory
for
Toxicology
and
Industrial
Medicine.
22
40886501
Schmidt,
W.
(
1985)
Diuron:
Study
for
Chronic
Toxicity
and
Carcinogenicity
with
Wistar
Rats
(
Administration
in
Diet
for
Up
to
Two
Years:
Project
ID:
T/
8010647;
Du
Pont
Report
No.
D/
TOX
17.
Unpublished
study
prepared
by
Bayer
AG.
1473
p.
40886502
Schmidt,
W.;
Karbe,
E.
(
1986)
Diuron:
Toxicological
Study
with
Wistar
Rats
Paying
Special
Attention
to
Effects
on
the
Blood
(
Administration
in
Diet
for
Six
Months):
Project
ID:
T7018927;
Du
Pont
Report
No.
D/
TOX
18.
Unpublished
study
prepared
by
Bayer
AG.
135
p.
41957301
Cook,
J.
(
1990)
Reproductive
and
Fertility
Effects
with
Diuron
(
IN
14740):
Multigeneration
Reproductive
Study
in
Rats:
Lab
Project
Number:
8670
001:
560
90.
Unpublished
study
prepared
by
E.
I.
du
Pont
de
Nemours
and
Co.
1080
p.
42159501
Eiben,
R.
(
1983)
Diuron:
Study
for
Chronic
Toxicity
and
Carcinogencity
with
NMRI
Mice
(
Administration
in
Diet
for
24
Months):
(
Trans.)
Lab
Project
Number:
T4010922:
DIUR/
TOX
9.
Unpublished
study
prepared
by
Bayer
Ag.
(
Wuppertal).
1532
p.
42718301
MacKenzie,
S.
(
1992)
Repeated
Dose
Dermal
Toxicity:
21
Day
Study
with
DPX
14740
166
(
Diuron)
in
Rabbits:
Lab
Project
Number:
9122
001:
484
92.
Unpublished
study
prepared
by
E.
I.
du
Pont,
Haskell
Lab.
198
p.
43349301
Hardesty,
P.;
van
Pelt,
C.
(
1994)
Volume
I
of
Supplementary
Data
Supporting
the
Diuron
2
Year
Feeding
Study
in
NMRI
Mice:
Lab
Project
Number:
MFS
1:
21534.
Unpublished
study
prepared
by
E.
I.
du
Pont
de
Nemours
and
Co.,
Inc.
131
p.
43804501
Rossberg,
W.
(
1995)
Volume
1
of
Supplementary
Data
Supporting
the
Diuron
2
Year
Feeding
Study
in
Rats:
Lab
Project
Number:
D/
TOX
17:
T8010647.
Unpublished
study
prepared
by
Bayer
Ag
Institute
of
Toxicology.
46
p.
43871901
Rossberg,
W.;
Wirnitzer,
U.
(
1995)
Addendum
1
Supporting
the
Diuron
2
Year
Feeding
Study
in
Rats:
Lab
Project
Number:
13962A:
T8010647.
Unpublished
study
prepared
by
Bayer
AG
Institute
of
Toxicology.
42
p.
44019601
Wu,
D.
(
1996)
Absorption,
Distribution,
Metabolism,
and
Elimination
of
(
carbon
14)
Diuron
in
Rats:
Lab
Project
Number:
AMR
3145
94:
XBL94161:
RPT00247.
Unpublished
study
prepared
by
XenoBiotic
Labs,
Inc.
and
E.
I.
du
Pont
de
Nemours
and
Co.
303
44302003
Malek,
D.
(
1997)
Volume
2
of
Supplementary
Data
Supporting
the
Diuron
Two
Year
Feeding
Study
in
Rats:
Lab
Project
Number:
D/
TOX
17:
T8010647:
13962
B.
Unpublished
study
prepared
by
DuPont
Agricultural
Products.
25
p.
44350301
Cox,
L.
(
1997)
In
vivo
Assay
of
Diuron
for
Chromosome
Aberrations
in
Rat
Bone
Marrow
Cells:
Revision
No.
2:
Lab
Project
Number:
7372
001:
HLR
#
366
85.
Unpublished
study
prepared
by
E.
I.
DuPont
Haskell
Laboratory
for
Toxicology
and
Diuron
RED
Toxicology
Chapter
26
Industrial
Medicine.
40
p.
45494501
Arce,
G
(
2001)
Diuron:
Cancer
Classification
and
mechanism
of
Action.
Report
No.
GRIFFDIUR052901.
Prepared
by
Griffin
LLC.
Valdosta,
GA.
781
p.
45494505
Herbold,
B.
(
1998)
Diuron:
Micronucleus
Test
on
the
Mouse.
Lab.
Project
Number:
PH
27204.
Unpublished
study
prepared
by
Bayer
Ag,
Toxicology.
U.
S.
EPA
Carcinogenicity
Peer
Review
of
Diuron.
December
18,
1996.
HED
Doc.
No.
012224.
Office
of
Pesticides
Program,
Health
Effects
Division,
U.
S.
EPA,
Washington,
DC.
U.
S.
EPA
Diuron:
Report
of
the
Hazard
Identification
Assessment
Review
Committee.
May
29,
2001.
HED
Doc.
No.
014596.
Office
of
Pesticides
Program,
Health
Effects
Division,
U.
S.
EPA,
Washington,
DC.
U.
S.
EPA
Diuron:
2nd
Report
of
the
Hazard
Identification
Assessment
Review
Committee.
August
28,
2001.
HED
Doc.
No.
014657.
Office
of
Pesticides
Program,
Health
Effects
Division,
U.
S.
EPA,
Washington,
DC.
U.
S.
EPA
Diuron:
Report
of
the
FQPA
Safety
Factor
Committee.
June
18,
2001.
HED
Doc.
No.
014635.
Office
of
Pesticides
Program,
Health
Effects
Division,
U.
S.
EPA,
Washington,
DC.
U.
S.
EPA
Diuron:
Assessment
of
Mode
of
Action
on
Bladder
Carcinogenicity.
September
20,
2001.
Office
of
Pesticides
Program,
Health
Effects
Division,
U.
S.
EPA,
Washington,
DC.
Diuron
RED
Toxicology
Chapter
27
9.0
APPENDICES
Tables
for
Use
in
Risk
Assessment
Diuron
RED
Toxicology
Chapter
28
9.1
Toxicity
Profile
Summary
Tables
9.1.1
Acute
Toxicity
Table
See
Section
4.1
9.1.2
Subchronic,
Chronic
and
Other
Toxicity
Tables
Guideline
No./
Study
Type
MRID
No.
(
year)/
Classification/
Doses
Results
870.3100
90
Day
oral
toxicity
in
rats
MRID
40886502
(
1988)
Acceptable/
Nonguideline
0,
4,
10,
or
25
ppm
(
0,
0.3,
0.7,
or
1.6
mg/
kg/
day
for
males
and
0,
0.3,
0.8,
1.8
mg/
kg/
day
for
females)
The
NOAEL
can
not
be
determined
based
on
equivocal
findings
in
the
urinary
bladder
including
blood
vessel
dilation,
reduced
transparency,
and
increased
firmness.
870.3200
21/
28
Day
dermal
toxicity
in
rabbits
MRID
42718301
(
1992)
Acceptable/
Guideline
0,
50,
500,
or
1200
mg/
kg/
day
Systemic
toxicity
NOAEL
=
1200
mg/
kg/
day
(
HDT)
870.3465
90
Day
inhalation
toxicity
Not
available
Not
available
870.3700a
Prenatal
developmental
toxicity
in
rats
MRID
40228801
(
1986)
Unacceptable/
Guideline
0,
16,
80,
or
400
mg/
kg/
day
Maternal
toxicity
NOAEL
=
16
mg/
kg/
day.
Maternal
toxicity
LOAEL
=
80
mg/
kg/
day,
based
on
decreased
body
weight
gain
and
food
consumption.
Developmental
toxicity
NOAEL=
80
mg/
kg/
day.
Developmental
toxicity
LOAEL
=
400
mg/
kg/
day,
based
on
whole
litter
resorption,
reduced
fetal
body
weights,
and
delayed
ossification
of
the
vertebrae
and
sternebrae.
870.3700b
Prenatal
developmental
toxicity
in
rabbits
MRID
40228802
(
1986)
Acceptable/
Guideline
0,
2,
10,
or
50
mg/
kg/
day
Maternal
toxicity
NOAEL
=
10
mg/
kg/
day.
Maternal
toxicity
LOAEL
=
50
mg/
kg/
day,
based
on
decreased
body
weight
and
food
consumption.
Developmental
toxicity
NOAEL
=
50
mg/
kg/
day
(
HDT).
Diuron
RED
Toxicology
Chapter
Guideline
No./
Study
Type
MRID
No.
(
year)/
Classification/
Doses
Results
29
870.3800
Reproduction
and
fertility
effects
in
rats
MRID
41957301
(
1990)
Acceptable/
Guideline
0,
10,
250,
or
1750
ppm.
(
0,
0.58,
14.8,
or
101
mg/
kg/
day
for
males
and
0,
0.71,
18.5,
or
131
mg/
kg/
day
for
females,
respectively.
Parental
NOAEL
=
250
ppm
(
18.6
mg/
kg/
day).
Parental
LOAEL
=
1750
ppm
(
132
mg/
kg/
day)
based
on
decreased
body
weight,
body
weight
gain,
food
consumption
and
food
efficiency
in
both
generations.
Reproductive
NOAEL
=
1750
ppm
(
HDT).
Offspring
NOAEL
=
250
ppm
(
18.6
mg/
kg/
day).
Offspring
LOAEL
=
1750
ppm
(
132
mg/
kg/
day)
based
on
decreased
body
weight
of
the
F1
and
F2
pups
during
lactation.
870.4200b
Chronic
toxicity
in
dogs
MRID
00091192
(
1964)
Unacceptable/
Guideline
0,
25,
125,
250,
or
2500/
1250
ppm
(
0,
1.8,
9.4,
18.8,
or
93.8
mg/
kg/
day
by
conversion
factor
of
0.075)
for
24
months.
NOAEL
=
125
ppm
(
9.4
mg/
kg/
day)
in
males
and
250
ppm
(
18.8
mg/
kg/
day)
for
females.
LOAEL
=
250
ppm
(
18.8
mg/
kg/
day)
for
males
and
1250
ppm
(
93.8
mg/
kg/
day)
for
females
based
on
anemia
and
body
weight
losses.
870.4300
Combined
Chronic/
Carcinogenicity
in
rats
MRID
40886501,43871901,
43804501,
44302003
(
1986)
Acceptable/
Guideline
0,
25,
250,
2500
ppm
(
0,
1.0,
10,
or
111
mg/
kg/
day
for
males
and
0,
1.7,
17,
or
202
mg/
kg/
day
for
females)
for
24
months.
NOAEL
=
Not
established.
LOAEL
=
25
ppm
(
1.0
mg/
kg/
day
for
males
and
1.7
mg/
kg/
day
for
females)
based
on
evidence
of
hemolysis
and
compensatory
hematopoiesis
(
decreased
erythrocyte
counts,
increased
reticylocyte
counts,
increased
spleen
weight
and
bone
marrow
activation).
Dosing
was
considered
adequate.
870.4300
Carcinogenicity
in
mice
MRID
42159501
(
1983)
Acceptable/
Guideline
0,
25,
250,
or
2500
ppm
(
0,
5.4,
50.8,
or
640.13
mg/
kg/
day
for
males
and
0,
7.5,
77.5,
or
867.0
mg/
kg/
day
for
females)
for
24
months
NOAEL
=
250
ppm
(
50.8
and
77.5
mg/
kg/
day)
for
males
and
females.
LOAEL
=
2500
ppm
(
640.1
and
867.0
mg/
kg/
day)
for
males
and
females
based
on
hemolytic
anemia
and
liver
toxicity
in
both
sexes
and
urinary
bladder
toxicity
in
females.
Dosing
was
considered
adequate.
870.5100
Gene
mutation
Salmonella
typhimurium
reverse
gene
mutation
MRID
00146608
(
1985),
40228805
(
1991)
Acceptable/
Guideline
Independent
trials
were
negative
in
S.
typhimurium
strains
TA1535,
TA97,
TA98
and
TA100
up
to
the
highest
dose
tested
(
10
µ
g/
plate
S9;
250
µ
g/
plate
+
S9);
higher
concentrations
(
$
50
µ
g/
plate
S9;
500
µ
g/
plate
+
S9)
were
cytotoxic.
Diuron
RED
Toxicology
Chapter
Guideline
No./
Study
Type
MRID
No.
(
year)/
Classification/
Doses
Results
30
870.5300
Gene
mutation
Chinese
hamster
ovary
(
CHO)/
HGPRT
cell
forward
gene
mutation
assay
MRID
00146609
(
1985)
Acceptable/
Guideline
Independent
tests
were
negative
up
to
cytotoxic
doses
without
S9
activation
(
1.250
mM,
.
291
µ
g/
mL)
and
with
S9
activation
(
0.5
mM
,
.
117
µ
g/
mL).
870.5375
Chromosomal
aberration
in
vivo
rat
bone
marrow
cytogenetic
assay
MRID
00146611
(
1985)
MRID
44350301
(
1997)(
Revised)
Acceptable/
Guideline
The
test
was
negative
in
Sprague
Dawley
rats
up
to
cytotoxic
doses.
A
significant
(
p<
0.05)
increase
in
the
percentage
of
abnormal
cells
and
the
average
number
of
aberrations
per
cell
was
seen
but
only
when
the
data
were
combined
for
the
high
and
mid
dose
males
and
females
at
the
48
hour
sampling
time.
A
significant
positive
linear
trend
was
also
recorded
for
the
combined
(
by
sex)
aberrations
per
cell
and
percentage
abnormal
cells.
Nevertheless,
the
values
fell
well
within
the
range
of
historical
control
ranges.
870.5550
Unscheduled
DNA
Synthesis
MRID
00146610
(
1985)
Acceptable/
Guideline
The
test
was
negative
up
to
cytotoxic
doses
(
$
0.33
mM,
equivalent
to
.
76
F
g/
mL).
870.7485
Metabolism
and
pharmacokinetics
MRID
42010501
(
1996)
Acceptable/
Guideline
Diuron
was
rapidly
absorbed,
metabolized
and
excreted.
Urine
was
the
major
route
of
excretion.
Metabolism
of
diuron
involved
N
oxidation,
ring
hydroxylation,
demethylation,
dechlorination,
and
conjugation
to
sulfate
and
glucuronic
acid.
870.7600
Dermal
penetration
Not
available
for
diuron.
Not
available.
Diuron
RED
Toxicology
Chapter
31
9.2
Summary
of
Toxicological
Dose
and
Endpoints
for
Diuron
for
Use
in
Human
Risk
Assessment1
Exposure
Scenario
Dose
Used
in
Risk
Assessment,
UF
FQPA
SF
and
Endpoint
for
Risk
Assessment
Study
and
Toxicological
Effects
Acute
Dietary
general
population
including
infants
and
children
There
is
no
appropriate
endpoint
attributed
to
a
single
exposure
(
dose)
was
identified
including
in
the
rat
or
rabbit
developmental
toxicity
study.
Therefore,
an
acute
RfD
was
not
established.
Chronic
Dietary
all
populations
LOAEL=
1.0
mg/
kg/
day
UF
=
300
Chronic
RfD
=
0.003
mg/
kg/
day
FQPA
SF
=
1x
cPAD
=
0.003
mg/
kg/
day
Combined
chronic/
carcinogenicity
study
in
rats.
LOAEL=
1.0
mg/
kg/
day
based
on
evidence
of
hemolytic
anemia
and
compensatory
hematopoiesis.
A
NOAEL
was
not
established.
Short
Term
Oral
(
1
30
days)
(
Residential)
NOAEL=
10
mg/
kg/
day
LOC
for
MOE
=
100
(
Residential,
includes
the
FQPA
SF)
Developmental
toxicity
study
in
rabbits.
LOAEL=
50
mg/
kg/
day
based
on
maternal
toxicity
(
decreased
body
weight
and
food
consumption).
Intermediate
Term
Oral
(
1
6
months)
(
Residential)
oral
study
NOAEL=
1.0
mg/
kg/
day
LOC
for
MOE
=
100
(
Residential,
includes
the
FQPA
SF)
Combined
chronic/
carcinogenicity
in
rats.
LOAEL
=
10
mg/
kg/
day
based
on
altered
hematological
parameters
observed
at
6
months.
Short
Term
Dermal
(
1
30
days)
Intermediate
Term
Dermal
(
1
6
months)
(
Occupational/
Residential)
No
systemic
toxicity
following
repeated
dermal
dosing
at
1200
mg/
kg/
day
was
seen
in
the
dermal
toxicity
study.
Also,
there
is
no
developmental
concern.
No
hazard
was
identified
and
no
quantitative
assessment
is
required.
Long
Term
Dermal
(
Longer
than
6
months)
(
Occupational/
Residential)
oral
study
LOAEL=
1.0
mg/
kg/
day
(
dermal
absorption
factor
=
4%)
LOC
for
MOE
=
300
(
Occupational)
LOC
for
MOE
=
300
(
Residential,
includes
the
FQPA
SF)
Combined
chronic/
carcinogenicity
in
rats.
Evidence
of
hemolytic
anemia
and
compensatory
hematopoiesis.
NOAEL
was
not
established.
Diuron
RED
Toxicology
Chapter
Exposure
Scenario
Dose
Used
in
Risk
Assessment,
UF
FQPA
SF
and
Endpoint
for
Risk
Assessment
Study
and
Toxicological
Effects
32
Short
Term
Inhalation
(
1
30
days)
(
Occupational/
Residential)
oral
study
NOAEL=
10
mg/
kg/
day
LOC
for
MOE
=
100
(
Occupational)
LOC
for
MOE
=
100
(
Residential,
includes
the
FQPA
SF)
Developmental
toxicity
study
in
rabbits.
LOAEL=
50
mg/
kg/
day
based
on
decreased
body
weight
and
food
consumption.
Intermediate
Term
Inhalation
(
1
6
months)
(
Occupational/
Residential)
oral
study
NOAEL=
1.0
mg/
kg/
day
LOC
for
MOE
=
100
(
Occupational)
LOC
for
MOE
=
100
(
Residential,
includes
the
FQPA
SF)
Combined
chronic/
carcinogenicity
in
rats.
LOAEL
=
10
mg/
kg/
day
based
on
altered
hematological
parameters
observed
at
6
months.
Long
Term
Inhalation
(
longer
than
6
months)
(
Occupational/
Residential)
oral
study
LOAEL=
1.0
mg/
kg/
day
LOC
for
MOE
=
300
(
Occupational)
LOC
for
MOE
=
300
(
Residential,
includes
the
FQPA
SF)
Combined
chronic/
carcinogenicity
in
rats.
Evidence
of
hemolytic
anemia
and
compensatory
hematopoiesis.
NOAEL
was
not
established.
Cancer
(
oral,
dermal,
inhalation)
Known/
likely
human
carcinogen
Q1*
=
1.91
x
10
2
(
mg/
kg/
day)
1
Urinary
bladder
carcinoma
in
both
sexes
of
the
Wistar
rat,
kidney
carcinomas
in
the
male
rat
(
a
rare
tumor),
and
mammary
gland
carcinomas
in
the
female
NMRI
mouse.
1
UF
=
uncertainty
factor,
FQPA
SF
=
FQPA
safety
factor,
NOAEL
=
no
observed
adverse
effect
level,
LOAEL
=
lowest
observed
adverse
effect
level,
PAD
=
population
adjusted
dose
(
a
=
acute,
c
=
chronic)
RfD
=
reference
dose,
LOC
=
level
of
concern,
MOE
=
margin
of
exposure
| epa | 2024-06-07T20:31:43.643473 | regulations | {
"license": "Public Domain",
"url": "https://downloads.regulations.gov/EPA-HQ-OPP-2002-0249-0015/content.txt"
} |
EPA-HQ-OPP-2002-0249-0016 | Supporting & Related Material | "2002-10-01T04:00:00" | null | R
UNITED
STATES
ENVIRONMENTAL
PROTECTION
AGENCY
WASHINGTON,
DC
20460
OFFICE
OF
PREVENTION,
PESTICIDES
AND
TOXIC
SUBSTANCES
MEMORANDUM
[
May
08,
1997]
[
TXR
#
0050671]
SUBJECT:
Carcinogenicity
Peer
Review
of
Diuron
FROM:
Linda
L.
Taylor,
Ph.
D.
Review
Section
II
Toxicology
Branch
II
Health
Effects
Division
(
7509C)
and
Esther
Rinde,
Ph.
D.
Manager,
Carcinogenicity
Peer
Review
Committee
Science
Analysis
Branch
Health
Effects
Division
(
7509C)
THROUGH:
Stephanie
R.
Irene,
Ph.
D.
Deputy
Director,
Health
Effects
Division
(
7509C)
TO:
Philip
Errico
Product
Manager
#
25
Fungicide
Herbicide
Branch
Registration
Division
(
7505C)
and
Larry
Schnaubelt
Special
Review
and
Reregistration
Division
(
7508W)
The
Health
Effects
Division
Carcinogenicity
Peer
Review
Committee
(
CPRC)
met
on
December
18,
1996
to
discuss
and
evaluate
the
weightof
the
evidence
on
Diuron
with
particular
reference
to
its
carcinogenic
potential.
In
accordance
with
the
EPA
proposed
Guidelines
for
Carcinogenic
Risk
Assessment
(
April
23,
1996)
Diuron
was
characterized
as
a
"
known/
likely"
human
carcinogen
by
all
routes,
based
on
urinary
bladder
carcinomas
in
both
sexes
of
the
Wistar
rat,
kidney
carcinomas
in
the
male
rat
(
a
rare
tumor),
and
mammary
gland
carcinomas
in
the
female
NMRI
mouse.
Information
from
structurally
related
analogs
provided
further
support.
Carcinogenicity
Peer
Review
of
Diuron
December
18,
1997
2
The
CPRC
recommended
that
for
the
purpose
of
risk
characterization,
a
low
dose
linear
extrapolation
model
be
applied
to
the
animal
data
for
the
quantification
of
human
risk,
based
on
the
urinary
bladder
carcinomas
in
the
male
rat.
Carcinogenicity
Peer
Review
of
Diuron
December
18,
1997
3
SUMMARY
Administration
of
Diuron
in
the
diet
to
NMRI
mice
resulted
in
increases
in
mammary
gland
adenocarcinomas
in
female
mice
which
had
statistically
significant
positive
trends;
there
were
no
pairwise
statistically
significant
increases.
The
incidence
of
tumors
at
the
highest
dose
(
2500
ppm)
exceeded
that
in
historical
controls
from
the
testing
facility.
There
were
no
apparent
significant
increases
in
tumors
in
male
mice.
The
CPRC
agreed
that
dosing
in
the
mouse
was
adequate,
and
not
excessive.
Administration
of
Diuron
in
the
diet
to
Wistar
rats
resulted
in
statistically
significant
increases
in
urinary
bladder
carcinomas
at
the
highest
dose
(
2500
ppm)
in
both
sexes;
there
were
also
statistically
significant
positive
trends
in
both
sexes.
The
incidences
at
the
highest
dose
was
73%
and
27%
(
vs
2%
in
concurrent
controls)
in
males
and
females,
respectively
and
were
well
in
excess
of
historical
controls
from
the
testing
facility.
In
male
rats
at
the
highest
dose,
there
were
also
increases
in
renal
epithelial
carcinomas
and
combined
papilloma/
carcinoma
which
had
a
statistically
significant
trend
for
the
combined
tumors
only.
There
were
no
pairwise
statistically
significant
increases
in
kidney
tumors;
however
the
numerical
increase
in
carcinomas
alone
(
4%
vs
O%
in
concurrent
controls)
was
considered
to
be
biologically
significant
because
of
the
rarity
of
this
tumor
type.
In
addition,
hyperplasia
of
the
urinary
bladder
at
lower
doses
noted
in
both
the
rat
and
mouse
studies
provided
further
support
that
the
kidney
tumors
(
as
well
as
the
bladder
tumors)
were
compound
related.
The
CPRC
agreed
that
dosing
in
the
rat
was
adequate,
and
not
excessive.
There
were
no
data
provided
by
the
Registrant
to
attribute
a
mechanism
for
the
carcinogenic
response
in
mice
or
rats.
Diuron
is
structurally
related
to
Linuron,
Fluometuron
and
Monuron
which
all
have
demonstrated
carcinogenic
activity
at
various
sites
in
rodents.
Only
Monuron
is
associated
with
tumors
in
the
kidney;
however,
differences
in
metabolism
may
account
for
the
site
differences
of
the
other
analogs.
Diuron
was
only
weakly
positive
(
considered
to
be
equivocal)
in
an
in
vivo
cytogenetic
study;
other
submitted
mutagenicity
studies
were
negative
or
inadequate.
Information
from
structurally
related
analogs
provided
further
support.
Carcinogenicity
Peer
Review
of
Diuron
December
18,
1997
1Also
a
member
of
the
PRC
for
this
chemical;
signature
indicates
concurrence
with
the
peer
review
unless
otherwise
stated.
2Signature
indicates
concurrence
with
pathology
report.
4
A.
Individuals
in
Attendance
at
the
meeting:
1.
Peer
Review
Committee:
(
Signatures
indicate
concurrence
with
the
peer
review
unless
otherwise
stated.)
William
Burnam
Marion
Copley
Kerry
Dearfield
Elizabeth
Doyle
Yiannakis
Ioannou
Esther
Rinde
2.
Reviewers:
(
Non
committee
members
responsible
for
data
presentation;
signatures
indicate
technical
accuracy
of
panel
report.)
Linda
Taylor1
Clark
Swentzel
Lori
Brunsman
Lucas
Brennecke2
(
PAI/
ORNL)
3.
Other
Attendees:
Albin
Kocialski
and
Bernice
Fisher
(
HED)
Carcinogenicity
Peer
Review
of
Diuron
December
18,
1997
5
Figure
2
Diuron
B.
Material
Reviewed
The
material
available
for
review
consisted
of
DER's,
oneliners
data
from
the
literature
and
other
data
summaries
prepared
and/
or
supplied
by
Dr.
Taylor,
and
tables
and
statistical
analysis
by
Lori
Brunsman.
The
material
reviewed
is
attached
to
the
file
copy
of
this
report.
C.
Background
Information
DIURON,
3[
3,4
dichlorophenyl]
1,1
dimethylurea
is
a
substituted
urea
herbicide
effective
against
emerging
and
young
broadleaf
and
grass
weeds
and
mosses.
Tolerances
for
residues
in
or
on
asparagus,
Bermuda
grass,
Bermuda
grass
hay;
alfalfa,
corn
fodder
or
forage
[
sweet
corn
field
corn,
popcorn],
grass
crops
[
other
than
Bermuda],
grass
hay
[
other
than
Bermuda],
hay,
forage
and
straw
of
barley,
oats,
rye,
and
wheat,
hay
and
forage
of
birdsfoot
trefoil,
clover,
peas,
and
vetch,
peppermint
hay,
sorghum
fodder
and
forage;
apples,
artichokes,
barley
grain,
blackberries,
blueberries,
boysenberries,
citrus
fruits,
corn
in
grain
and
ear
form
[
including
sweet,
field
and
popcorn],
cottonseed,
currants,
dewberries,
gooseberries,
grapes,
huckleberries,
loganberries,
oat
grain,
olives,
pears,
peas,
pineapple,
potatoes,
raspberries,
rye
grain,
sorghum
grain,
sugarcane,
vetch
(
seed),
wheat
grain;
meat,
fat
and
meat
byproducts
of
cattle,
goats,
hogs,
horses,
and
sheep;
bananas,
nuts,
and
peaches;
and
papayas
have
been
established.
The
CAS
Registry
Number
[
CAS
NO.]
is
150
68
5.
The
PC
Code
is
035505.
The
Tox.
Chemical
No.
is
410.
D.
Evaluation
of
Carcinogenicity
Evidence
1.
Carcinogenicity
Study
in
Mice
Reference:
DIURON:
Study
for
Chronic
Toxicity
and
Carcinogenicity
with
NMRI
Mice
(
Administration
in
Diet
for
24
Months).
[
Study
#
Bayer
AG
T
4010922,
DuPont
Report
#
DIUR/
TOX9,
dated
October,
1983
Carcinogenicity
Peer
Review
of
Diuron
December
18,
1997
6
[
translation
completed
January,
1991];
MRID
#
42159501;
Document
Nos.
009486
and
010902011030.
Addendum:
MRID
#
43349301
[
Supplemental
Data
and
Background
Tumor
Incidences].
a.
Experimental
Design
Groups
of
Bor
strain
NMRI
[
SPF
HAN]
mice
of
both
sexes
[
50
mice/
sex/
dose
(
carcinogenicity);
10
mice/
sex/
group
(
12
month
interim
group)]
were
administered
Diuron
[
98.7%
pure]
via
the
diet
at
dose
levels
of
0,
25
ppm
[
%
%
5.5/
&
&
7.5
mg/
kg/
day],
250
ppm
[
%
%
50.8/
&
&
77.5
mg/
kg/
day],
or
2500
ppm
[
%
%
640.1/
&
&
869.0
mg/
kg/
day]
for
24
months.
b.
Discussion
of
Tumor
Data
MALES
There
were
no
statistically
significant
tumors
observed
in
male
mice.
FEMALES
Female
mice
had
significant
increasing
trends
in
mammary
gland
adenocarcinomas
and
ovarian
luteomas,
both
at
p
<
0.05.
There
were
no
significant
differences
in
the
pair
wise
comparisons
of
the
dosed
groups
with
the
controls.
[
Table
8
from
L.
Brunsman
memo
dated
11/
20/
96;
reproduced
here
as
Table
1].
TABLE
1.
DIURON
NMRI
Mouse
Study
Female
Mammary
Gland
and
Ovarian
Tumor
Rates+
and
Peto's
Prevalence
Test
Results
(
p
values)
Dose
(
ppm)
0
25
250
2500
Mammary
Gland
Adenocarcinomas
2/
34
1a/
29
1/
44
6/
37
(%)
(
6)
(
3)
(
2)
(
16)
p
=
0.016*
0.560
0.403
0.159
Ovarian
Luteomas
3/
34
1/
32
2/
46
7b/
41
(%)
(
9)
(
3)
(
4)
(
17)
p
=
0.024*
0.330n
0.358n
0.243
+
Number
of
tumor
bearing
mice/
Number
of
mice
examined,
excluding
those
that
died
before
week
54.
Also
excludes
week
53
interim
sacrifice
mice.
aFirst
mammary
gland
adenocarcinoma
observed
at
week
78,
dose
25
ppm.
bFirst
uterine
luteoma
observed
at
week
53,
dose
0
ppm,
in
an
interim
Carcinogenicity
Peer
Review
of
Diuron
December
18,
1997
7
sacrifice
mouse.
Second
uterine
luteoma
observed
at
week
72,
dose
2500
ppm,
in
a
mouse
that
died
on
study.
nNegative
change
from
control.
(
)
Percent
Note:
One
animal
in
the
control
group
of
the
interim
sacrifice
group
had
a
uterine
luteoma.
Interim
sacrifice
mice
are
not
included
in
this
analysis.
Significance
of
trend
denoted
at
control.
Significance
of
pair
wise
comparison
with
control
denoted
at
dose
level.
If
*,
then
p
<
0.05.
If
**,
then
p
<
0.01.
Carcinogenicity
Peer
Review
of
Diuron
December
18,
1997
8
FEMALES:
When
compared
to
historical
control
data
from
published
papers
of
studies
on
NMRI
mice,
the
Registrant
stated
that
spontaneous
ovarian
tumors
are
usually
rare
in
mice
except
in
certain
strains,
which
include
Han:
NMRI
mice.
From
the
literature,
the
incidence
of
ovarian
tumors
in
these
mice
can
be
influenced
by
the
age
at
terminal
sacrifice,
husbandry
conditions,
source
of
stock,
and
the
nutritional
status
[
i.
e.,
obese
vs
lean],
and
variability
among
pathologists
in
classification
of
these
tumors
affects
the
reported
incidence.
The
Registrant
stated
that
primary
ovarian
tumors
are
classified
on
the
assumption
that
these
tumors
arise
from
one
of
three
ovarian
components:
epithelium
[
either
of
the
ovarian
surface
or
rete
ovarii],
germ
cells,
or
ovarian
stroma,
including
sex
cords,
which
probably
contribute
cells
to
ovarian
follicles
and
thus
to
the
endocrine
apparatus
of
the
ovary.
Tumors
of
the
latter
group
are
termed
sex
cord
stromal
tumors
and
include
granulosa
cell
tumors,
luteomas,
thecomas,
Sertoli
cell
tumors
of
the
ovary,
Leydig
cell
tumors,
androblastoma,
arrhenoblastoma,
or
lipid
cell
tumors.
It
is
further
stated
that
NTP
recommends
combining
the
incidence
of
the
sex
cord
stromal
tumors
for
statistical
assessment
of
tumor
data.
In
addition
to
the
similarity
in
the
histogenesis
of
the
granulosa/
theca
cell
tumors
and
luteomas,
any
one
of
these
tumors
may
have
components
of
the
other.
For
this
reason,
several
groups
of
pathologists
consider
luteoma
and
thecoma
as
morphologic
variants
of
granulosa
cell
tumors,
differing
only
in
their
degree
and
direction
of
differentiation.
Therefore,
the
Registrant
combined
the
sex
cord
stromal
tumors
[
Table
2]
in
the
ovaries
and
analyzed
by
the
Cochran
Armitage
test
for
trend
and
found
no
significant
increase
in
tumors
and
the
percent
incidence
falls
within
the
reported
range
for
spontaneous
occurrence
[
0
35.5%].
Also
provided
were
historical
control
data
from
18
studies
performed
at
the
BAYER
testing
facility.
With
respect
to
ovarian
tumor
data,
9
of
the
18
studies
list
luteoma
[
0
6.8%],
and
the
highest
number
is
3,
which
occurred
in
2
studies
[
3/
44
and
3/
45
mice].
Carcinogenicity
Peer
Review
of
Diuron
December
18,
1997
9
Table
2.
Ovarian
Tumor
Incidence
Registrant's
Analysis
Tumor/
Dose
0
ppm
25
ppm
250
ppm
2500
ppm
OVARIAN
TUMORS
n=
granulosa/
thec.
tumors
unilat.
benign
bilat.
benign
unilat.
malignant
luteoma
unilat.
benign
bilat.
benign
combined
sex
cord
stromal
tumors
*
tubular
cystadenoma,
benign
leiomyoma,
unilat.
benign
teratoma,
unilat.
benign
50
7
[
14]
Ë
1
[
2]
0
3
[
6]
0
11
[
22]
2
[
4]
00
47
4
[
9]
1
[
2]
1
[
2]
0
1
[
2]
7
[
15]
1
[
2]
0
1
[
2]
49
11
[
22]
2
[
4]
0
2
[
4]
0
15
[
31]
1
[
2]
00
50
5
[
10]
2
[
4]
0
7
[
14]**
0
14
[
28]
0
1
[
2]
0
Ë
[%];
*
sum
of
all
sex
cord
stromal
tumors,
including
all
granulosa/
theca
tumors
and
all
luteomas;
**
p<
0.01
At
the
Diuron
Carcinogenicity
Peer
Review
meeting
December
18,
1996,
it
was
decided
that
the
female
mouse
ovarian
tumor
rates
table
should
reflect
the
more
appropriate
"
combined
sex
chordstromal
tumors"
nomenclature
in
lieu
of
the
"
luteoma"
terminology
used
in
the
qualitative
risk
assessment
(
Lori
L.
Brunsman
to
Linda
L.
Taylor,
11/
20/
96).
Dr.
Lucas
Brennecke,
EPA's
consulting
pathologist,
confirmed
that
the
combined
tumor
counts
are
more
appropriate
than
the
individual
counts
for
ovarian
tumors,
as
it
is
difficult
to
distinguish
between
the
different
types
of
ovarian
tumors.
Since
only
the
luteoma
tumor
counts
have
been
verified,
the
counts
for
the
combined
sex
chord
stromal
tumors
have
been
taken
from
Table
2,
page
3,
of
the
Diuron
data
package,
which
was
extracted
from
the
registrant's
analysis.
Female
mice
do
not
have
a
significant
increasing
trend,
or
any
significant
differences
in
the
pair
wise
comparisons
of
the
dosed
groups
with
the
controls,
for
ovarian
combined
sex
cord
stromal
tumors
[
L.
Brunsman
memo
dated
12/
18/
96].
This
statistical
analysis
was
based
upon
the
Exact
trend
test
and
the
Fisher's
Exact
test
for
pair
wise
comparisons.
See
Table
1a
for
female
mouse
ovarian
tumor
analysis
results.
Carcinogenicity
Peer
Review
of
Diuron
December
18,
1997
10
Table
1a.
Diuron
NMRI
(
SPF
HAN)
Mouse
Study
Female
Ovarian
Tumor
Rates+
and
Exact
Trend
Test
and
Fisher's
Exact
Test
Results
(
p
values)
Dose
(
ppm)
0
25
250
2500
Combined
Sex
Cord
Stromal
Tumors
11/
34
7/
32
15/
46
14/
41
(%)
(
32)
(
22)
(
33)
(
34)
p
=
0.268
0.249n
0.588
0.534
+
Number
of
tumor
bearing
animals/
Number
of
animals
examined,
excluding
those
that
died
before
week
54.
Also
excludes
week
53
interim
sacrifice
animals.
nNegative
change
from
control.
Note:
Interim
sacrifice
animals
are
not
included
in
this
analysis.
Significance
of
trend
denoted
at
control.
Significance
of
pair
wise
comparison
with
control
denoted
at
dose
level.
If
*,
then
p
<
0.05.
If
**,
then
p
<
0.01.
With
regard
to
the
mammary
gland,
the
Registrant
states
that
mouse
mammary
gland
tumors
are
classified
as
1)
adenocarcinoma
type
A
[
synonyms:
adenoma
simple,
acinar
carcinoma,
adenocarcinoma
simple],
2)
adenocarcinoma
type
B
[
synonyms:
irregular
tubular
adenocarcinoma,
solid
polygonal
cell
carcinoma,
intratubular
carcinoma,
papillary
cystic
adenocarcinoma,
intracanalicular
adenocarcinoma],
3)
adenocarcinoma
type
C
[
synonyms:
fibroadenoma,
adenofibroma],
4)
adenocanthoma
[
synonyms:
keratinizing
tumors,
mammary
tumor
with
keratinization,
squamous
carcinoma,
metaplastic
carcinoma,
adenocarcinoma,
variable,
type
IV],
5)
carcinosarcoma
[
synonyms:
spindle
cell
carcinoma,
sarcomatoid
carcinoma],
6)
sarcoma,
and
7)
miscellaneous
tumors.
It
is
stated
that
the
mammary
tumors
observed
in
the
Diuron
study
in
mice
are
synonymous
with
adenocarcinoma
types
A
and
B.
Their
analysis
shows
a
statistically
significant
increase
in
the
incidence
of
malignant
[
12%]
mammary
adenocarcinomas
in
the
high
dose
females.
The
spontaneous
incidence
of
malignant
mammary
gland
tumors
[
carcinoma,
Types
A/
B
combined]
in
Han:
NMRI
female
mice
is
stated
to
be
9
14%
in
ad
libitum
fed
mice
and
2
9%
in
food
restricted
fed
mice.
There
is
no
age
specific
appearance
of
carcinomas.
The
Registrant
concludes
that
because
the
incidence
is
within
the
published
historical
control
range,
Diuron
is
not
carcinogenic
for
the
mammary
gland
[
Table
3].
In
the
historical
control
data
from
Carcinogenicity
Peer
Review
of
Diuron
December
18,
1997
11
the
testing
facility
[
16
studies],
the
highest
number
of
mice
observed
with
a
malignant
mammary
gland
tumor
was
3,
which
occurred
in
3
studies
[
3/
48,
3/
48,
3/
49
mice;
range
0
6.3%].
Table
3.
Mammary
Tumor
Incidence
Registrant's
Analysis
Tumor/
Dose
[
ppm]
0
25
250
2500
MAMMARY
GLAND
TUMORS
n=
mammary
adenocarcinoma,
malignant
mammary
carcinoma,
anaplastic,
malignant
mammary
gland
tumors,
combined
50
2
[
4]
Ë
02
[
4]
47
1
[
2]
1
[
2]
2
[
4]
49
1
[
2]
01
[
2]
50
6*
[
12]
0
6*
[
12]
Ë
[%];
*
p<
0.05
c.
Non
Neoplastic
Lesions
MALES:
The
incidence
of
several
non
neoplastic
liver
lesions
was
significantly
increased
at
the
high
dose
compared
to
the
concurrent
control
[
Table
4].
There
were
no
adverse
findings
in
the
urinary
bladder.
Tissue/
Lesion/
Dose
(
ppm)
MALES
Table
4.
Microscopic
Findings
Non
Neoplastic
[
%
%
/
&
&
]
0
25
250
2500
Liver
N=
enlarged
degenerative
hepatopathy
increased
mitosis
single
cell
necrosis
8
accumulation
of
Kupffer
Cells
45/
46
0/
0
1/
0
1/
0
3/
12
6/
9
48/
38
0/
1
0/
0
2/
3
2/
7
6/
9
46/
48
0/
3
0/
0
0/
0
5/
10
8/
9
46/
46
0/
10**
15**/
0
8**/
4*
7*/
19**
11*/
9
*
p<
0.05;
**
p<
0.01;
FEMALES:
The
incidence
of
non
neoplastic
lesions
in
the
mammary
gland
and
ovaries
were
comparable
among
the
groups.
At
the
highdose
level,
there
was
an
increased
incidence
of
epithelial
hyperplasia,
edema,
and
thickened
mucosa
in
the
urinary
bladder
[
Table
5].
Carcinogenicity
Peer
Review
of
Diuron
December
18,
1997
12
Tissue/
Lesion/
Dose
(
ppm)
FEMALES
Table
5.
Microscopic
Findings
Non
Neoplastic
0
25
250
2500
Urinary
Bladder
N=
epithelial
hyperplasia
edema
mucosa
thickened
46
500
36
500
45
300
44
23**
17**
5**
*
p<
0.05;
**
p<
0.01;
data
from
page
62
of
report.
d.
Adequacy
of
the
Dosing
for
Assessment
of
Carcinogenicity
The
statistical
evaluation
of
mortality
indicated
no
significant
incremental
change
with
increasing
doses
of
Diuron
in
either
male
or
female
mice.
The
highest
dose
tested
[
2500
ppm]
was
considered
adequate.
Signs
of
toxicity
at
this
dose
level
include
(
1)
decreased
body
weight
gain
for
both
sexes
[
%
%
90%/
&
&
87%
of
control
overall],
(
2)
increased
spleen
and
liver
weights
in
males,
(
3)
increased
leucocyte
and
reticulocyte
counts,
mean
corpuscular
volume,
mean
corpuscular
hemoglobin,
and
bilirubin
values
in
both
sexes,
(
4)
increased
incidence
of
intracellular
pigments
in
the
renal
tubules
in
females
and
in
the
spleen
of
both
sexes,
(
5)
increased
incidence
of
hemosiderin
deposits
in
liver
cells
in
males,
(
6)
increased
incidence
of
liver
single
cell
necrosis
and
cell
mitosis
in
both
sexes,
(
7)
increased
incidence
of
enlarged
degenerative
cells
in
the
liver
in
females
and
of
hepatopathy
and
accumulation
of
Kupffer
cells
in
males,
and
(
8)
increased
incidence
of
urinary
bladder
edema
and
epithelial
hyperplasia,
thickened
mucosa,
and
enlarged
uterine
horn
in
females.
The
HED
RfD
Committee
discussed
Diuron
at
the
9/
26/
96
meeting
and
concluded
that
the
study
was
acceptable;
i.
e.,
the
dose
levels
were
considered
adequate.
The
NOEL
is
250
ppm
[
%
%
50.5/
&
&
77.5
mg/
kg/
day],
and
the
LOEL
is
2500
ppm
[
%
%
640.1/
&
&
869.0
mg/
kg/
day],
based
on
the
effects
listed
above.
The
CPRC
agreed
that
dosing
in
the
mouse
study
was
adequate
(
not
excessive)
for
assessing
the
carcinogenicity
potential
of
Diuron
in
mice.
2.
Combined
Chronic
Toxicity/
Carcinogenicity
Study
in
Rats
Reference:
Diuron:
Study
for
Chronic
Toxicity
and
Carcinogenicity
with
Wistar
Rats
(
Administration
in
Diet
for
up
to
Two
Years)
[
BAYER
AG
T
8010647;
DuPont
Report
No.
D/
Tox
17,
dated
11/
29/
85;
MRID
#
40886501;
Document
No.
008160].
a.
Experimental
Design
Carcinogenicity
Peer
Review
of
Diuron
December
18,
1997
13
Wistar
rats
[
50/
sex/
group
for
104
weeks;
10/
sex/
group
for
interim
52
week
sacrifice]
were
fed
Diuron
at
dose
levels
of
0,
25
ppm
[
%
%
1.02/
&
&
1.69
mg/
kg/
day],
250
ppm
[
%
%
10.46/
&
&
16.88
mg/
kg/
day],
or
2500
ppm
[
%
%
111.17/
&
&
202.22
mg/
kg/
day].
b.
Discussion
of
Tumor
Data
MALES:
Male
rats
had
significant
increasing
trends,
and
significant
differences
in
the
pair
wise
comparisons
of
the
2500
ppm
dose
group
with
the
controls,
for
urinary
bladder
epithelial
carcinomas,
and
papillomas
and/
or
carcinomas
combined,
all
at
p
<
0.01.
Male
rats
also
had
a
significant
increasing
trend
in
kidney
renal
pelvis
epithelial
papillomas
and/
or
carcinomas
combined
at
p
<
0.05.
[
Tables
3
and
4
of
L.
Brunsman
memo,
reproduced
here
as
Tables
6
and
7].
FEMALES:
Female
rats
had
significant
increasing
trends,
and
significant
differences
in
the
pair
wise
comparisons
of
the
2500
ppm
dose
group
with
the
controls,
for
urinary
bladder
epithelial
carcinomas,
and
papillomas
and/
or
carcinomas
combined,
all
at
p
<
0.01.
[
Table
5
of
L.
Brunsman
memo,
reproduced
here
as
Table
8].
Table
6.
DIURON
Wistar
Rat
Study
Male
Urinary
Bladder
Epithelial
Tumor
Rates+
and
Exact
Trend
Test
and
Fisher's
Exact
Test
Results
(
p
values)
Dose
(
ppm)
0
25
250
2500
Papillomas
0/
49
0/
50
0/
49
1a/
48
(%)
(
0)
(
0)
(
0)
(
2)
p
=
0.245
1.000
1.000
0.495
Carcinomas
1/
49
0/
50
1/
49
35b/
48
(%)
(
2)
(
0)
(
2)
(
73)
p
=
0.000**
0.495n
0.753
0.000**
Combined
1/
49
0/
50
1/
49
35c/
48
(%)
(
2)
(
0)
(
2)
(
73)
p
=
0.000**
0.495n
0.753
0.000**
+
Number
of
tumor
bearing
rats/
Number
of
rats
examined,
excluding
those
that
died
or
were
sacrificed
before
week
53.
Also
excludes
week
52
interim
sacrifice
animals.
aFirst
papilloma
observed
at
week
104,
dose
2500
ppm.
Carcinogenicity
Peer
Review
of
Diuron
December
18,
1997
14
bFirst
carcinoma
observed
at
week
81,
dose
2500
ppm.
cOne
rat
in
the
2500
ppm
dose
group
had
both
a
papilloma
and
a
carcinoma.
nNegative
change
from
control.
(
)
Percent
Note:
Interim
sacrifice
rats
are
not
included
in
this
analysis.
Significance
of
trend
denoted
at
control.
Significance
of
pair
wise
comparison
with
control
denoted
at
dose
level.
If
*,
then
p
<
0.05.
If
**,
then
p
<
0.01.
Carcinogenicity
Peer
Review
of
Diuron
December
18,
1997
15
Table
7.
DIURON
Wistar
Rat
Study
Male
Kidney
Renal
Epithelial
Tumor
Rates+
and
Exact
Trend
Test
and
Fisher's
Exact
Test
Results
(
p
values)
Dose
(
ppm)
0
25
250
2500
Papillomas
0/
49
0/
50
0/
50
1a/
48
(%)
(
0)
(
0)
(
0)
(
2)
p
=
0.244
1.000
1.000
0.495
Carcinomas
0/
49
0/
50
0/
50
2b/
48
(%)
(
0)
(
0)
(
0)
(
4)
p
=
0.058
1.000
1.000
0.242
Combined
0/
49
0/
50
0/
50
3/
48
(%)
(
0)
(
0)
(
0)
(
6)
p
=
0.014*
1.000
1.000
0.117
+
Number
of
tumor
bearing
rats/
Number
of
rats
examined,
excluding
those
that
died
or
were
sacrificed
before
week
53.
Also
excludes
week
52
interim
sacrifice
rats.
aFirst
papilloma
observed
at
week
104,
dose
2500
ppm.
bFirst
carcinoma
observed
at
week
104,
dose
2500
ppm.
Note:
Interim
sacrifice
rats
are
not
included
in
this
analysis.
Significance
of
trend
denoted
at
control.
Significance
of
pair
wise
comparison
with
control
denoted
at
dose
level.
If
*,
then
p
<
0.05.
If
**,
then
p
<
0.01.
Carcinogenicity
Peer
Review
of
Diuron
December
18,
1997
16
Table
8.
DIURON
Wistar
Rat
Study
Female
Urinary
Bladder
Epithelial
Tumor
Rates+
and
Exact
Trend
Test
and
Fisher's
Exact
Test
Results
(
p
values)
Dose
(
ppm)
0
25
250
2500
Papillomas
0/
47
0/
49
2a/
50
0/
49
(%)
(
0)
(
0)
(
4)
(
0)
p
=
0.560
1.000
0.263
1.000
Carcinomas
1/
47
0/
49
1/
50
13b/
49
(%)
(
2)
(
0)
(
2)
(
27)
p
=
0.000**
0.490n
0.737
0.001**
Combined
1/
47
0/
49
3/
50
13c/
49
(%)
(
2)
(
0)
(
6)
(
27)
p
=
0.000**
0.490n
0.332
0.001**
+
Number
of
tumor
bearing
rats/
Number
of
rats
examined,
excluding
those
that
died
before
week
44.
Also
excludes
week
52
interim
sacrifice
rats.
aFirst
papilloma
observed
at
week
104,
dose
250
ppm.
bFirst
carcinoma
observed
at
week
44,
dose
2500
ppm.
cOne
rat
in
the
2500
ppm
dose
group
had
both
a
papilloma
and
a
carcinoma.
nNegative
change
from
control.
Note:
Interim
sacrifice
rats
are
not
included
in
this
analysis.
Significance
of
trend
denoted
at
control.
Significance
of
pair
wise
comparison
with
control
denoted
at
dose
level.
If
*,
then
p
<
0.05.
If
**,
then
p
<
0.01.
Carcinogenicity
Peer
Review
of
Diuron
December
18,
1997
17
When
compared
to
historical
controls
of
the
testing
facility,
the
incidence
of
transitional
epithelial
carcinomas
[
malignant
tumors
of
the
bladder
epithelium]
at
the
high
dose
level
exceeds
the
historical
control
incidence
[
range
not
provided],
and
the
maximum
[
2%]
incidence
at
the
low
and
mid
dose
levels
was
said
to
be
within
the
spontaneous
rate.
With
regard
to
the
uterus,
the
slight
increase
in
the
number
of
adenocarcinomas
and
total
malignant
neoplasias
observed
at
the
high
dose
level
was
not
statistically
significant
either
on
a
pairwise
comparison
or
trend
basis
[
personnel
communication
from
L.
Brunsman].
The
spontaneous
incidence
of
adenocarcinomas
was
listed
as
2%
20%,
with
a
mean
of
8%.
Table
9.
Uterine
Tumor
Incidence
Tumor/
Dose
[
ppm]
0
25
250
2500
UTERUS
n=
adenocarcinoma,
malignant
endometrial
sarcoma,
malignant
squamous
cell
carcinoma,
malignant
48
500
50
500
50
501
50
921
c.
Non
Neoplastic
Lesions
MALES
There
was
an
increased
incidence
of
hyperplasia
in
the
renal
pelvis
and
urinary
bladder
with
dose,
and
the
severity
of
the
lesion
was
also
increased
[
Table
10].
In
the
kidney,
round
cell
infiltration
was
increased
at
the
high
dose
level
compared
to
the
control
and
lower
dose
levels.
Carcinogenicity
Peer
Review
of
Diuron
December
18,
1997
18
Table
10.
Non
neoplastic
Lesions
in
the
Male
Rat
Lesion/
Dose
0
ppm
25
ppm
250
ppm
2500
ppm
Renal
Pelvis
#
examined
focal
hyperplasia/
epithelium
total
Grade
1
Grade
2
Grade
3
50
37
31
51
50
37
30
70
50
45
18
25
2
47
43
3
23
17
Urinary
Bladder
#
examined
urothelial
hyperplasia
total
Grade
1
Grade
2
Grade
3
50
13
11
20
50
5500
50
16
15
10
49
14
13
10
Kidney
#
examined
round
cell
infiltration
50
3
50
12
50
9
49
31
Spleen
#
examined
hyperemia/
blood
congestion
fibrosis
50
0
0
50
0
0
50
1
3
49
15
16
Thyroids
#
examined
C
cell
hyperplasia
50
29
48
27
50
37
49
39
Bone
Marrow
#
examined
activated
50
0
50
5
50
7
49
42
FEMALES
There
was
an
increased
incidence
of
hyperplasia
in
the
renal
pelvis
and
urinary
bladder
with
dose,
and
the
severity
of
the
lesion
was
also
increased
[
Table
11].
Glandular
cystic
hyperplasia
was
increased
slightly
at
the
high
dose
level,
and
the
high
dose
displayed
increased
fibrosis
in
the
spleen.
Increased
incidences
of
lesions
also
occurred
in
the
liver,
thyroid,
and
bone
marrow.
Carcinogenicity
Peer
Review
of
Diuron
December
18,
1997
19
Table
11.
Non
neoplastic
Lesions
in
the
Female
Rat
Lesion/
Dose
0
ppm
25
ppm
250
ppm
2500
ppm
Renal
Pelvis
#
examined
focal
hyperplasia/
epithelium
total
Grade
1
Grade
2
Grade
3
48
23
20
3
0
50
25
22
3
0
50
46
12
30
4
47
42
5
33
4
Urinary
Bladder
#
examined
urothelial
hyperplasia
total
Grade
1
Grade
2
Grade
3
48
11
10
10
49
7700
50
17
935
50
30
4
17
9
Kidney
#
examined
round
cell
infiltration
48
7
49
9
50
12
50
3
Uterus
#
examined
glandular
cystic
hyperplasia
48
3
50
5
50
2
50
7
Spleen
#
examined
hemosiderin
storage
fibrosis
48
44
0
50
46
0
50
50
0
50
49
17
Liver
#
examined
fatty
degeneration
round
cell
infiltration
hyperemia
bile
duct
infiltration
vacuolar
degeneration
of
liver
cells
48
04
19
16
0
50
09
32
10
1
50
1
10
33
15
3
50
3
13
36
25
11
Thyroids
#
examined
C
cell
hyperplasia
47
17
49
23
50
30
48
28
Bone
Marrow
#
examined
activated
48
5
50
12
50
22
50
42
d.
Adequacy
of
Dosing
for
Assessment
of
Carcinogenicity
The
statistical
evaluation
of
mortality
indicated
no
significant
incremental
changes
with
increasing
doses
of
Diuron
in
either
male
or
female
rats.
The
HED
RfD
Committee
discussed
Diuron
at
the
9/
26/
96
meeting
and
concluded
that
the
rat
study
was
Acceptable
as
supplementary
data
due
to
deficiencies
with
respect
to
the
Carcinogenicity
Peer
Review
of
Diuron
December
18,
1997
20
examination
of
organs.
Specific
concern
was
expressed
that
the
mammary
gland
was
not
examined
in
the
rat
study,
given
the
fact
that
mammary
gland
tumors
were
observed
to
be
increased
in
the
mouse
study.
There
was
no
NOEL
determined
in
the
rat
study,
and
the
LOEL
was
considered
to
be
25
ppm,
the
lowest
dose
tested,
based
on
decreased
erythrocyte
count
in
females,
increased
hemosiderin
in
the
spleen,
increased
spleen
weight,
bone
marrow
activation,
increased
hematopoietic
marrow,
decreased
fat
marrow,
and
thickened
urinary
bladder
wall
in
males.
The
RfD
Committee
recommended
that
the
chronic
toxicity/
carcinogenicity
study
in
rats
be
repeated.
The
CPRC
concluded
that
the
dosing
in
the
rat
study
was
adequate
(
not
excessive)
for
assessing
the
carcinogenic
potential
of
Diuron
in
rats.
E.
Additional
Toxicology
Data
on
Diuron
1.
Metabolism
Reference:
Although
the
HED
Metabolism
Peer
Review
Committee
expressed
concern
about
the
lack
of
metabolism
data
for
Diuron
in
the
rat,
and
TB
II
informed
SRRD
that
the
Registrant
should
be
requested
to
submit
a
rat
metabolism
study
[
memo
dated
11/
18/
93],
no
study
was
located
in
the
files.
2.
Mutagenicity
References:
(
a)
Rickard,
L.
B.,
et
al.
[
1985].
Mutagenicity
Evaluation
of
Diuron
in
the
CHO/
HGPRT
Assay
MRID#
00146609;
Document
No.
005039]
(
b)
Sarrif,
A.
[
1985].
Assessment
of
Diuron
in
the
In
Vivo
Cytogenetic
Study
in
Rats
MRID#
00146611,
Document
No.
005039]
(
c)
Arce,
G.
T.
and
Sarrif,
A.
M.
[
1985].
Assessment
of
Diuron
in
the
In
Vitro
Unscheduled
DNA
Synthesis
Assay
in
Primary
Rat
Hepatocytes
MRID#
00146610;
Document
No.
005039]
(
d)
Arce,
G.
T.
[
1987]
Mutagenicity
Evaluation
(
of
Diuron)
in
Salmonella
typhimurium
MRID#
s
00146608
and
40228805;
Document
Nos.
005039
and
008751].
a.
CHO/
HGPRT
assay.
Negative.
Under
the
conditions
of
the
experiment,
Diuron
up
to
cytotoxic
levels
with
and
without
metabolic
activation
was
negative.
b.
In
vivo
cytogenetic
study
in
rats.
Positive
Under
the
conditions
of
the
assay,
Diuron
was
weakly
clastogenic
at
5000
mg/
kg,
the
highest
dose
tested
[
HDT].
Carcinogenicity
Peer
Review
of
Diuron
December
18,
1997
21
c.
In
vitro
unscheduled
DNA
synthesis
[
UDS]
assay.
Negative.
Under
the
conditions
of
the
assay,
doses
of
Diuron
up
to
20
mM
[
HDT]
were
negative,
but
the
RfD
Committee
recommended
reevaluation
of
the
study.
d.
Salmonella
typhimurium
reverse
gene
mutation
assay.
Negative.
Under
the
conditions
of
the
study,
the
results
were
negative.
Carcinogenicity
Peer
Review
of
Diuron
December
18,
1997
22
Figure
3
Linuron
3.
Structure
Activity
Relationship
Diuron
is
a
substituted
urea
herbicide.
(
1)
Linuron
is
classified
a
Group
C
carcinogen
without
quantitation
[
hepatocellular
adenomas
in
female
CD
1
mice
at
HDT
[
1500
ppm]
and
testicular
adenoma/
hyperplasia
in
male
Crl:
CD(
SD)
BR
Sprague
Dawley
rats.
Linuron
was
negative
in
the
Ames
assay
at
dose
levels
up
to
5
g/
plate,
with
and
without
activation;
did
not
produce
gene
mutations
in
an
in
vitro
assay
using
CHO
cells
both
with
and
without
activation;
did
not
induce
bone
marrow
chromosome
aberrations
in
vivo;
did
not
induce
unscheduled
DNA
synthesis
in
rat
hepatocytes.
(
2)
Fluometuron
classified
a
Group
C
carcinogen
with
both
a
low
dose
extrapolation
model
(
Q*
1)
applied
to
the
animal
data
[
lung
tumors
in
male
CD
1
mice]
and
the
Reference
Dose
[
RfD]
approach
[
combined
adenomas/
carcinomas
of
the
lungs
in
male
mice
and
malignant
lymphocytic
lymphomas
in
female
mice
[
dose
levels
considered
inadequate
too
low].
Fluometuron
did
not
induce
UDS
in
primary
rat
hepatocytes
at
dose
levels
that
were
sufficiently
high;
was
negative
for
inducing
micronuclei
at
a
toxic
dose
level;
and
was
negative
in
the
Ames
assay
when
tested
up
to
the
limit
dose
[
5000
µ
g/
plate].
(
3)
Monuron
has
not
been
reviewed
by
HED
CPRC.
Kidney
and
liver
tumors
have
been
reported
in
F344/
N
rats;
malignant
gastric
adenoma,
microcellular
cancer
of
lung,
seminoma
in
testes
in
rats
and
benign
hepatoma,
alveolocellular
cancer
and
cancer
of
the
kidney
have
been
reported
in
old
Russian
studies.
(
4)
Siduron
was
not
reviewed
by
CPRC
and
data
has
not
been
reviewed.
During
the
Phase
II
review,
mutagenicity
studies
were
identified
and
assessed
as
adequate
for
review,
and
a
2
year
rat
study
was
to
be
submitted;
there
is
no
evidence
that
the
studies
were
forwarded
to
HED
for
review.
Carcinogenicity
Peer
Review
of
Diuron
December
18,
1997
23
Figure
4
Fluometuron
Figure
6
Siduron
Figure
5
Monuron
Carcinogenicity
Peer
Review
of
Diuron
December
18,
1997
24
F.
Weight
of
Evidence
Considerations
The
Committee
was
asked
to
consider
the
following
facts
regarding
the
toxicology
data
on
Diuron
in
the
Weight
of
the
Evidence
determination
of
its
carcinogenic
potential:
1.
Male
and
female
NMRI
(
SPF
Han)
mice
were
fed
0,
25,
250,
or
2500
ppm
of
Diuron
for
104
weeks.
There
was
no
adverse
effect
on
survival
of
either
sex.
Neoplastic
findings
were
observed
only
at
the
high
dose
in
females
compared
with
the
controls.
Female
mice
had
a
significant
increasing
trend
in
mammary
gland
adenocarcinomas
at
p
<
0.05.
There
were
no
significant
differences
in
the
pair
wise
comparisons
of
the
dosed
groups
with
the
controls.
The
incidence
of
this
tumor
appears
to
be
outside
the
testing
facility's
historical
control.
2.
Wistar
rats
were
fed
Diuron
at
dose
levels
of
0,
25
ppm
[
%
%
1.02/
&
&
1.69
mg/
kg/
day],
250
ppm
[
%
%
10.46/
&
&
16.88
mg/
kg/
day],
or
2500
ppm
[
%
%
111.17/
&
&
202.22
mg/
kg/
day].
There
was
no
adverse
effect
on
survival
of
either
sex.
Neoplastic
findings
were
observed
in
the
urinary
bladder
of
both
sexes
and
in
the
renal
pelvis
of
the
males
compared
with
the
controls.
Male
rats
had
significant
increasing
trends,
and
significant
differences
in
the
pair
wise
comparisons
of
the
2500
ppm
dose
group
with
the
controls,
for
urinary
bladder
epithelial
carcinomas,
and
papillomas
and/
or
carcinomas
combined.
Male
rats
also
had
a
significant
increasing
trend
in
kidney
renal
pelvis
epithelial
papillomas
and/
or
carcinomas
combined.
Female
rats
had
significant
increasing
trends,
and
significant
differences
in
the
pair
wise
comparisons
of
the
2500
ppm
dose
group
with
the
controls,
for
urinary
bladder
epithelial
carcinomas,
and
papillomas
and/
or
carcinomas
combined.
The
incidence
of
these
tumors
is
greater
than
the
historical
control
incidence.
3.
From
the
submitted
studies,
Diuron
was
very
weakly
positive
in
the
rat
in
vivo
cytogenetic
assay
at
5000
mg/
kg,
negative
in
the
CHO/
HGPRT
assay,
negative
in
the
in
vitro
UDS
assay
and
negative
Carcinogenicity
Peer
Review
of
Diuron
December
18,
1997
25
in
the
reverse
gene
mutation
assay
in
Salmonella
typhimurium.
There
is
little
identified
mutagenic
concern
with
respect
to
Diuron.
4.
Structure
Activity.
Linuron
is
a
Group
C
carcinogen
without
quantitation
[
hepatocellular
adenomas
in
female
CD
1
mice
at
HDT
[
1500
ppm]
and
testicular
adenoma/
hyperplasia
in
male
Crl:
CD(
SD)
BR
Sprague
Dawley
rats.
Fluometuron
is
a
Group
C
carcinogen
with
both
a
low
dose
extrapolation
model
(
Q*
1)
applied
to
the
animal
data
[
lung
tumors
in
male
CD
1
mice]
and
the
Reference
Dose
[
RfD]
approach
[
combined
adenomas/
carcinomas
of
the
lungs
in
male
mice
and
malignant
lymphocytic
lymphomas
in
female
mice
[
dose
levels
considered
inadequate
too
low].
Carcinogenicity
Peer
Review
of
Diuron
December
18,
1997
26
G.
Classification
of
Carcinogenic
Potential:
The
Peer
Review
Committee
considered
the
EPA
proposed
Guidelines
for
Carcinogenic
Risk
Assessment
(
April
10,
1996)
for
classifying
the
weight
of
evidence
for
Diuron.
In
accordance
with
these
proposed
Guidelines,
the
CPRC
unanimously
agreed
to
characterize
the
weight
of
the
evidence
for
Diuron
as
"
known/
likely"
to
be
carcinogenic
to
humans
by
all
routes
of
exposure
based
on:
the
robust
tumor
response
of
carcinomas
in
the
urinary
bladder
in
both
sexes
of
the
Wistar
rat;
kidney
carcinomas
(
a
rare
tumor)
in
the
male
Wistar
rat;
and
mammary
gland
carcinomas
in
the
female
NMRI
mouse.
There
is
no
known
data
on
human
exposure
to
Diuron.
Diuron
is
a
member
of
a
chemical
class
(
substituted
ureas)
of
which
Linuron,
Fluometuron
and
Monuron
have
demonstrated
carcinogenic
activity
at
various
sites
in
rodents.
Diuron
was
only
weakly
positive
in
an
in
vivo
cytogenicity
study,
which
was
considered
to
be
equivocal
and
other
submitted
mutagenicity
studies
were
either
negative
or
inadequate.
No
mechanistic
or
mode
of
action
data
were
presented
to
justify
the
quantification
of
human
risk
by
a
method
other
than
the
low
dose
linear
extrapolation
default.
The
CPRC
recommended
that
for
the
purpose
of
risk
characterization,
a
low
dose
linear
extrapolation
model
be
applied
to
the
animal
data
for
the
quantification
of
human
risk,
based
on
the
urinary
bladder
carcinomas
in
the
male
rat.
The
CPRC
recommended
that
the
in
vivo
cytogenicity
study
be
repeated.
| epa | 2024-06-07T20:31:43.665576 | regulations | {
"license": "Public Domain",
"url": "https://downloads.regulations.gov/EPA-HQ-OPP-2002-0249-0016/content.txt"
} |
EPA-HQ-OPP-2002-0249-0017 | Supporting & Related Material | "2002-10-01T04:00:00" | null | 1
UNITED
STATES
ENVIRONMENTAL
PROTECTION
AGENCY
WASHINGTON,
D.
C.
20460
OFFICE
OF
PREVENTION,
PESTICIDES
AND
TOXIC
SUBSTANCES
DATE:
October
10,
2001
MEMORANDUM
SUBJECT:
DIURON:
Cancer
Classification
and
Mechanism
of
Action
FROM:
Yung
G.
Yang,
Ph.
D.
Reregistration
Branch
2
Health
Effects
Division
(
7509C)
THROUGH:
Pauline
Wagner,
Branch
Chief
Reregistration
Branch
2
Health
Effects
Division
(
7509C)
TO:
Diana
Locke,
Ph.
D.,
Risk
Assessor
Reregistration
Branch
2
Health
Effects
Division
(
7509C)
And
Roberta
Farrell
/
Kathy
Monk
PM
52
Special
Review
and
Reregistration
Division
(
7508W)
DP
Barcode:
D278246
Submission:
S604292
Chemical:
Diuron
Case:
818790
PC
Code:
035505
CAS
No.:
330
54
1
Action:
Review
and
respond
to
Registrant's
submission
entitled
"
Cancer
Classification
and
Mechanism
of
Action"
(
MRID
45494501)
and
mutagenicity
studies
(
MRIDs
45494502
05).
Response:
The
Reregistration
Branch
2
(
RRB2)
reviewed
the
submitted
data
and
presented
it
to
the
HED
Mechanism
of
Toxicity
Assessment
Review
Committee
(
MTARC).
A
pre
screening
subgroup
of
the
MTARC
evaluated
the
proposed
mechanism
of
action
with
the
data
submitted
by
the
Registrant
and
concluded
that
the
submitted
information
is
insufficient
to
support
a
mode
of
action
on
bladder
carcinogenicity
for
diuron.
After
consulting
with
the
Chair
of
the
Cancer
Assessment
Review
Committee
(
CARC),
the
RRB2
determined
that
there
is
insufficient
information
to
support
a
2
reclassification
of
cancer
category
for
diuron
at
this
time.
Diuron
3
I.
Background
Diuron
[
3(
3,4
dichlorophenyl)
1,1
dimethylurea]
is
a
substituted
urea
herbicide
for
the
control
of
a
wide
variety
of
annual
and
perennial
broadleaves
and
grassy
weeds
on
both
crop
and
noncrop
sites.
In
1996,
the
HED
Carcinogenicity
Peer
Review
Committee
(
CPRC)
has
classified
diuron
as
a
"
known/
likely"
human
carcinogen
by
all
routes,
based
on
urinary
bladder
carcinoma
in
both
sexes
of
the
Wistar
rat,
kidney
carcinomas
in
the
male
rat
(
a
rare
tumor),
and
mammary
gland
carcinomas
in
the
female
NMRI
mouse.
The
CPRC
also
recommended
a
low
dose
linear
extrapolation
model
with
Q1
*
of
1.91x10
2
(
mg/
kg/
day)
1
be
applied
to
the
animal
data
for
the
quantification
of
human
risk,
based
on
the
urinary
bladder
carcinomas
in
the
rat.
The
Registrant
argues
that
this
assessment
needs
reconsideration
for
the
following
reasons:
(
1)
There
is
no
history
of
human
carcinogenesis
as
the
result
of
diuron
exposure.
(
2)
There
is
a
plausible
mode
of
action
that
discounts
the
relevance
of
the
rat
bladder
carcinomas
to
humans.
(
3)
The
mouse
historical
data
was
not
considered
in
its
entirety
and
should
be
considered
`
spontaneous'.
(
4)
The
structure
activity
relationships
actually
decrease
the
weight
of
the
evidence
of
diuron
carcinogenicity
rather
than
increase
the
weight,
and
(
5)
New
guidelines
are
in
place
that
separate
the
`
known'
from
`
likely'
category
(
extracted
from
pages
7
8
of
Registrant's
submission,
MRID
45494501).
The
responses
of
the
RRB2
are
as
follows.
II.
The
Responses
of
RRB2
1.
There
is
no
history
of
human
carcinogenesis
as
the
result
of
diuron
exposure.
RRB2
Response:
The
Registrant
did
not
submit
any
data
or
information
to
support
its
claim;
in
addition,
it
cannot
be
used
to
rule
out
any
remote
possibility
of
human
carcinogenesis
as
the
result
of
diuron
exposure.
2.
There
is
a
plausible
mode
of
action
that
discounts
the
relevance
of
the
rat
bladder
carcinomas
to
humans.
RRB2
Response:
The
document
entitled
"
Diuron:
Cancer
Classification
and
mechanism
of
Action"
(
MRID
44302002,
resubmitted
as
MRID
45494501)
has
been
submitted
to
the
HED
MTARC
for
evaluation.
The
MTARC
concluded
that
the
submitted
information
is
insufficient
to
support
a
mode
of
action
on
bladder
carcinogenicity
for
diuron
based
on
the
following
reasons
(
extracted
from
the
HED
MTARC
Report):
(
1)
The
Registrant
claimed
that
a
mechanism
or
mode
of
action
document
has
been
submitted
to
the
Diuron
4
Agency
without
being
reviewed
by
the
CPRC.
The
pre
screening
committee
reviewed
the
document
and
found
that
the
document
is
only
a
report
of
an
analysis
using
two
models
(
quantal
polynomial
multistage
and
Weibull
models)
to
evaluate
carcinogenic
risk
to
human
of
dietary
exposure
to
diuron.
This
study
was
not
designed
to
nor
was
it
intended
to
address
a
mode
of
action
on
bladder
carcinogenicity
of
diuron.
(
2)
A
study
entitled
"
Study
for
toxicity
to
Wistar
rats
with
special
attention
to
urothelial
alterations,
unpublished
data"
by
Schmidt
and
Karbe
(
1987)
indicated
that
male
Wistar
rats
were
fed
diuron
in
their
diet
at
a
concentration
of
2500
ppm
for
2,
4,
12,
or
26
weeks.
Recovery
groups
were
similarly
treated
for
4
or
26
weeks
and
then
observed
for
4
8
weeks.
Histopathological
examination
of
urinary
bladders
revealed
a
treatment
related
increased
incidence
of
hyperplasia
of
the
epithelium
and
an
increase
in
the
degree
of
hyperplasia
from
a
treatment
duration
of
four
weeks
onwards.
Examination
of
animals
in
the
recovery
groups
revealed
a
clear
trend
toward
reversibility
of
the
induced
alterations
after
cessation
of
treatment.
The
pre
screening
committee
concluded
that
this
study
suggested
a
reversibility
of
possible
precancerosis
but
did
not
present
or
propose
a
mode
of
action
on
bladder
carcinogenicity
for
diuron.
(
3)
The
Registrant
submitted
published
literature
in
an
attempt
to
address
the
role
of
diet
and
pH
of
the
rat
urine
for
supporting
the
mode
of
action
on
bladder
carcinogenicity
of
diuron.
The
pre
screening
committee
reviewed
these
literature
reports
and
determined
that
these
reports
were
either
non
diuron
specific
or
irrelevant
to
diuron.
The
Registrant
did
not
provide
direct
evidence
to
support
a
mode
of
action
on
dietary
influence
and
high
pH
value
as
the
mechanism
on
bladder
carcinogenicity
for
diuron.
(
4)
The
Registrant
cited
a
rat
metabolism
study
on
diuron
(
HED
Doc.
No.
012408)
and
stated
that
there
are
no
common
mechanisms
among
diuron,
linuron,
and
propanil
with
regard
to
cancer
endpoints.
No
further
information
was
presented.
The
pre
screening
committee
determined
that
the
Registrant
did
not
demonstrate
a
relevance
of
the
metabolism
of
diuron
to
mode
of
action
on
bladder
carcinogenicity.
(
5)
The
CPRC
report
(
1997)
has
indicated
that
diuron
was
only
weakly
positive
(
considered
being
equivocal)
in
an
in
vitro
cytogenetic
study.
The
Registrant
submitted
several
reports
on
mouse
bone
marrow
micronucleus
study
to
show
that
diuron
is
non
genotoxic.
The
pre
screening
committee
referred
its
decision
to
latest
HIARC
Report
on
mutagenicity
(
HED
Doc.
No.
014657,
dated
August
28,
2001).
The
HIARC
report
stated
that
"
diuron
was
not
mutagenic
in
bacteria
or
in
cultured
mammalian
cells
and
no
indication
of
DNA
damage
in
primary
rat
hepatocytes
was
observed.
There
was
weak
evidence
of
an
in
vivo
clastogenic
response
in
Sprague
Dawley
rats
in
one
study
and
statistically
significant
increases
in
cells
with
structural
aberrations
in
a
second
study
conducted
with
the
same
rat
strain.
The
data
from
the
latter
study,
however,
were
shown
to
fall
within
the
historical
control
range."
The
pre
screening
committee
concurred
with
the
Registrant
that
there
is
little
or
no
concern
on
mutagenic
activity
of
diuron.
Diuron
5
3.
The
mouse
historical
data
was
not
considered
in
its
entirety
and
should
be
considered
`
spontaneous'.
RRB2
Response:
The
mouse
historical
data
has
been
reviewed
and
included
in
the
updated
DER
(
MRIDs
42159501
and
43349301).
It
was
concluded
that
a
positive
oncogenic
response
was
seen
in
high
dose
female
mice
compared
to
the
control
group.
The
following
conclusions
are
extracted
from
the
discussion
section
of
the
DER.
The
study
authors
presented
data
from
historic
controls
performed
from
1981
to
1988
using
mice
of
the
same
strain
from
the
same
source
that
showed
mammary
gland
adenocarcinoma
incidences
that
ranged
from
0%
to
13%
with
the
average
frequency
being
3.2%.
This
same
source
showed
ovarian
luteoma
frequencies
ranging
from
0%
to
7%
[
Bomhard,
E.
(
1992)
Historical
control
data
showing
the
frequency
of
tumors
in
NMRI
mice
taken
from
18
long
term
studies
over
21
months,
Bayer
Report
No.
21534].
An
additional
reference
provided
historic
control
data
collected
from
studies
done
from
1974
through
1981
[
Bomhard,
E.
and
Mohr,
U.
(
1989)
Spontaneous
tumors
in
NMRI
mice
from
carcinogenicity
studies.
Exp.
Pathol.
36:
129
145].
In
the
latter
reference,
the
mammary
adenocarcinoma
average
incidence
was
3.9%
with
a
range
of
0%
to
10.8%
and
the
ovarian
granulosa
cell
tumor
average
frequency
was
19.1%
with
a
range
of
5.0%
to
35.5%.
Ovarian
luteomas
develop
from
granulosa
cells,
but
were
not
specifically
identified
in
the
reference.
Compared
to
the
historic
data,
the
mammary
adenocarcinoma
incidences
seen
in
the
control
group
in
the
current
study
agree
well,
but
the
incidences
in
the
high
dose
group
are
at,
or
slightly
above,
the
upper
limit
of
that
seen
in
control
animals.
The
ovarian
luteoma
instances
seen
in
the
current
study
are
slightly
high
in
the
control
group
and
well
above
the
normal
range
at
2500
ppm
compared
to
the
historic
control
animals;
however,
the
luteoma
incidences
are
not
outside
the
upper
range
for
all
granulosa
cells
derived
tumors
according
to
the
historic
data.
The
statistical
significance
of
the
increased
incidences
in
this
study
depends
on
a
test
for
trend;
the
differences
are
not
statistically
significant
according
to
the
Fisher's
exact
test
performed
by
the
reviewer.
The
study
authors
concluded
that
the
increased
incidences
of
mammary
and
ovarian
neoplasms
in
high
dose
female
mice
compared
to
the
control
group
were
not
treatment
related.
This
conclusion
is
questionable
because
the
incidences
of
spontaneous
tumors
in
normal
control
populations
of
this
strain
of
mice
vary
considerably,
and
the
best
control
is
usually
thought
to
be
the
one
that
was
performed
during
the
current
study.
Under
the
conditions
of
this
study,
a
positive
oncogenic
response
was
seen
in
high
dose
female
mice
compared
to
the
control
group.
4.
The
structure
activity
relationships
actually
decrease
the
weight
of
the
evidence
of
diuron
carcinogenicity
rather
than
increase
the
weight.
RRB2
Response:
This
issue
has
been
reviewed
and
addressed
by
the
MTARC.
Please
see
above
RRB2
response
#
2.
5.
New
guidelines
are
in
place
that
separate
the
`
known'
from
`
likely'
category.
Diuron
6
RRB2
Response:
The
1999
Guidelines
for
Carcinogen
Risk
Assessment
is
a
preliminary
draft
and
should
not
be
used
as
a
justification
for
cancer
reclassification.
The
document
has
a
notice
in
the
front
page
stated
that
"
THIS
DOCUMENT
IS
A
PRELIMINARY
DRAFT.
It
has
not
been
formally
released
by
the
U.
S.
Environmental
protection
Agency
and
should
not
at
this
stage
be
construed
to
represent
Agency
policy."
Additional
information
6.
Mouse
bone
marrow
micronucleus
assays
(
MRIDs
45494502
05).
RRB2
Response:
Preliminary
reviews
have
been
conducted
on
these
in
vivo
cytogenetic
mutagenicity
studies.
No
evidence
of
cytogenetic
effect
is
seen
in
mice
administered
either
technical
grade
or
formulated
diuron.
However,
these
studies
provide
little
additional
information
since
the
CARC
has
already
concluded
that
there
is
little
or
no
concern
on
mutagenic
activity
of
diuron.
III.
Conclusion
The
RRB2
evaluated
the
submitted
data
with
MTARC
report
and
concluded,
after
consulting
with
the
Chair
of
the
HED
CARC,
that
there
is
insufficient
information
to
support
a
reclassification
of
cancer
category
for
diuron
at
this
time.
Therefore,
the
cancer
classification
for
diuron
remains
the
same
as
"
known/
likely
human
carcinogen
with
a
Q1
*
of
1.91x10
2
(
mg/
kg/
day)
1
be
applied
to
the
animal
data
for
the
quantification
of
human
risk,
based
on
the
urinary
bladder
carcinomas
in
the
rat.
Diuron
7
SignOff
Date:
10/
10/
01
DP
Barcode:
D278246
HED
DOC
Number:
014696
Toxicology
Branch:
RRB2
| epa | 2024-06-07T20:31:43.674798 | regulations | {
"license": "Public Domain",
"url": "https://downloads.regulations.gov/EPA-HQ-OPP-2002-0249-0017/content.txt"
} |
EPA-HQ-OPP-2002-0249-0018 | Supporting & Related Material | "2002-10-01T04:00:00" | null | 1
UNITED
STATES
ENVIRONMENTAL
PROTECTION
AGENCY
WASHINGTON,
D.
C.
20460
OFFICE
OF
PREVENTION,
PESTICIDES
AND
TOXIC
SUBSTANCES
DATE:
September
20,
2001
MEMORANDUM
SUBJECT:
Diuron
(
PC
Code
035505):
Assessment
of
Mode
of
Action
on
Bladder
Carcinogenicity
FROM:
Yung
G.
Yang,
Ph.
D.
Reregistration
Branch
2
Health
Effects
Division
(
7509C)
THRU:
Pauline
Wagner,
Co
Chair
Mechanism
of
Toxicity
Assessment
Review
Committee
(
MTARC)
Health
Effects
Division
(
7509C)
and
Karl
Baetcke,
Co
Chair
Mechanism
of
Toxicity
Assessment
Review
Committee
(
MTARC)
Health
Effects
Division
(
7509C)
TO:
William
Burnham,
Senior
Science
Advisor
Chairman,
Cancer
Assessment
Review
Committee
(
CARC)
Immediate
Office
Health
Effects
Division
(
7509C)
cc:
Anna
Lowit,
Executive
Secretary,
MTARC
Diana
Locke,
Risk
Assessor,
RRB
2
Action:
The
Registrant
submitted
a
document
entitled
"
Cancer
Classification
and
Mechanism
of
Action
of
Diuron"
and
asked
the
Agency
to
reevaluate
the
cancer
classification
of
diuron
based
on
a
proposed
mode
of
action
on
bladder
carcinogenicity.
The
MTARC
is
asked
to
review
and
determine
the
relevance
of
the
proposed
mode
of
action
on
bladder
carcinogenicity
for
diuron.
Conclusion:
A
pre
screening
subgroup
of
the
MTARC
has
evaluated
the
proposed
mode
of
action
with
the
data
submitted
by
the
Registrant
and
concluded
that
the
submitted
information
is
insufficient
to
support
a
mode
of
action
on
bladder
carcinogenicity
for
diuron.
Diuron
2
I.
Background
Diuron
[
3(
3,4
dichlorophenyl)
1,1
dimethylurea]
is
a
substituted
urea
herbicide
for
the
control
of
a
wide
variety
of
annual
and
perennial
broadleaves
and
grassy
weeds
on
both
crop
and
noncrop
sites.
In
1997,
the
HED
Carcinogenicity
Peer
Review
Committee
(
CPRC)
has
classified
diuron
as
a
"
known/
likely"
human
carcinogen
by
all
routes,
based
on
urinary
bladder
carcinoma
in
both
sexes
of
the
Wistar
rat,
kidney
carcinomas
in
the
male
rat
(
a
rare
tumor),
and
mammary
gland
carcinomas
in
the
female
NMRI
mouse.
The
CPRC
also
recommended
a
low
dose
linear
extrapolation
model
with
Q1
*
of
1.91x10
2
(
mg/
kg/
day)
1
be
applied
to
the
animal
data
for
the
quantification
of
human
risk,
based
on
the
urinary
bladder
carcinomas
in
the
rat.
Empirical
formula:
C9H10Cl
2N2O
Molecular
weight:
233.1
CAS
Registry
No.:
330
54
1
PC
Code:
035505
NH
N
CH
3
CH3
O
Cl
Cl
II.
A
Proposed
Mode
of
Action
on
Bladder
Carcinogenicity
for
Diuron
The
Registrant
stated
that
the
tumorigenesis
of
diuron
does
not
represent
an
expression
of
primary
carcinogenic
potential
by
diuron
or
its
metabolites,
it
represents
a
concurrence
of
factors
such
as
a
high
dose,
dietary
influence,
metabolism
and
urinary
pH.
The
Registrant
proposed
several
basic
elements
to
support
this
mode
of
action.
The
first
is
the
etiology
of
the
lesion,
the
second
is
the
role
of
diet
and
pH
of
the
rat
urine,
the
third
is
the
actual
metabolism
of
diuron
and
the
fourth
is
the
nongenotoxicity
of
diuron.
Documents
submitted
by
the
Registrant
to
support
this
mode
of
action
are
as
follows.
(
1)
Diuron
Risk
Assessment:
Evaluation
of
Dietary
Exposure
(
MRID#
44302002).
Bogdanffy,
M.
S.,
1997.
Haskell
Lab.
No.
HL
1997
00613.
E.
I.
Du
Pont
de
Nemours
and
Company.
(
2)
Oral
Toxicity
and
Metabolism
of
Diuron
in
Rats
and
Dogs.
Hodge
et
al.,
1967.
Fd.
Cosmet.
Toxicol.
5:
513
531.
(
3)
Study
for
Toxicity
to
Wistar
Rats
with
Special
Attention
to
Urothelial
Alterations
(
Administration
in
Diet
for
2,
4,
12,
and
26
Weeks
with
Recovery).
Schmidt
and
Karbe,
1987.
unpublished
data.
(
4)
Risk
Assessment
Based
on
High
Dose
Animal
Exposure
Experiments.
Cohen
and
Ellwen,
1992.
Chem.
Res.
Toxicol.
5:
742
748.
(
5)
Induction
of
Hyperplasia
in
the
Bladder
Epithelium
of
Rats
by
a
Dietary
Excess
of
Acid
or
Base:
Diuron
3
Implications
for
Toxicity/
Carcinogenicity
Testing.
Groot
et
al.,
1988.
Fd.
Chem.
Toxicol.
5:
425
434.
(
6)
Lack
of
Bladder
Tumor
Promoting
Activity
in
Rats
Fed
Sodium
Saccharin
in
AIN
76A
Diet.
Okamura
et
al.,
1991.
Cancer
Research
51:
1778
1782.
(
7)
Mitogenic
Effects
of
Propoxur
on
Male
Rat
Bladder
Urothelium.
Cohen
et
al.,
1994.
Carcinogenesis
15:
2593
2597.
(
8)
Rapid
Induction
of
Hyperplasia
in
Vitro
in
Rat
Bladder
Explants
by
Elevated
Sodium
Ion
Concentrations
and
Alkaline
pH.
Storer
et
al.,
1996.
Toxicol.
Appl.
Pharm.
138:
219
230.
(
9)
Tributyl
Phosphate
Effects
on
Urine
and
Bladder
Epithelium
in
Male
Sprague
Dawley
Rats.
Arnold
et
al.,
1997.
Fund.
Appl.
Toxicol.
40:
247
255.
(
10)
Species
Specific
Mechanisms
of
Carcinogenesis.
Swenberg
et
al.
(
Eds.),
1992.
Mechanism
of
Carcinogenesis
in
Risk
Identification.
pp.
477
500.
(
11)
Tumors
of
the
Kidney,
Renal
Pelvis
and
Ureter.
Hard,
G.
C.
(
source
not
provided).
(
12)
Influence
of
Food
Restriction
and
Body
Fat
on
Life
Span
and
Tumor
Incidence
in
Female
Outbred
Han:
NMRI
Mice
and
Two
Sublines.
Rehm
et
al.,
1985.
Z.
Versuchtierk
27:
249
283.
(
13)
The
Interpretation
of
Equivocal
or
Marginal
Animal
Carcinogenicity
Tests.
Squire,
R.
A.
1989.
Cell
Biol.
Toxicol.
5:
371
376.
(
14)
Micronucleus
Induction
by
Diuron
in
Mouse
Bone
Marrow.
Agrawal
et
al.
1996.
Toxicol.
Lett.
89:
1
4.
(
15)
Diuron:
Micronucleus
Test
on
the
Mouse
to
Evaluate
for
Mutagenic
Effect.
Herbold,
B.
1983.
Report
No.
11915,
Bayer
AG,
Inst.
of
Toxicology.
(
16)
Diuron:
Micronucleus
Test
on
the
Mouse.
Herbold,
B.
1998.
Report
no.
PH
27204.
Bayer
AG
Toxicology.
(
17)
Mouse
Bone
Marrow
Micronucleus
Assay
of
DPX
14740
194
(
Karmex
®
DF).
Biegel,
L.
B.
1995.
Haskell
Lab
No.
682
95.
E.
I.
Du
pont
de
Nemours
and
Company.
(
18)
Mouse
Bone
Marrow
Micronucleus
Assay
of
DPX
14740
200
(
Karmex
®
500
SC).
Biegel,
L.
B.
1995.
Haskell
Lab
No.
683
95.
E.
I.
Du
pont
de
Nemours
and
Company.
(
19)
Mouse
Bone
Marrow
Micronucleus
Assay
of
DPX
14740
205
(
Karmex
®
800
WP).
Cox
L.
R.
1996.
Haskell
Lab
No.
688
95.
E.
I.
Du
pont
de
Nemours
and
Company.
III.
MTARC
Response
A
pre
screening
MTARC
(
Karl
Baetcke,
Mike
Ioannou,
Anna
Lowit,
Pauline
Wagner,
and
Yung
Yang)
reviewed
the
available
information
and
concluded
that
the
submitted
information
is
insufficient
to
support
a
mode
of
action
on
bladder
carcinogenicity
for
diuron
based
on
the
following
reasons:
(
1)
The
Registrant
claimed
that
a
mechanism
or
mode
of
action
document
(
MRID#
44302002)
has
been
submitted
to
the
Agency
without
being
reviewed
by
the
CPRC.
The
pre
screening
committee
Diuron
4
reviewed
the
document
and
found
that
the
document
is
only
a
report
of
an
analysis
using
two
models
(
quantal
polynomial
multistage
and
Weibull
models)
to
evaluate
carcinogenic
risk
to
human
of
dietary
exposure
to
diuron.
This
study
was
not
designed
to
nor
was
it
intended
to
address
a
mode
of
action
on
bladder
carcinogenicity
of
diuron.
(
2)
A
study
entitled
"
Study
for
toxicity
to
Wistar
rats
with
special
attention
to
urothelial
alterations
by
Schmidt
and
Karbe
(
1987),
unpublished
data"
indicated
that
male
Wistar
rats
were
fed
diuron
in
their
diet
at
a
concentration
of
2500
ppm
for
2,
4,
12,
or
26
weeks.
Recovery
groups
were
similarly
treated
for
4
or
26
weeks
and
then
observed
for
4
8
weeks.
Histopathological
examination
of
urinary
bladders
revealed
a
treatment
related
increased
incidence
of
hyperplasia
of
the
epithelium
and
an
increase
in
the
degree
of
hyperplasia
from
a
treatment
duration
of
four
weeks
onwards.
Examination
of
animals
in
the
recovery
groups
revealed
a
clear
trend
toward
reversibility
of
the
induced
alterations
after
cessation
of
treatment.
The
pre
screening
committee
concluded
that
this
study
suggested
a
reversibility
of
possible
precancerosis
but
did
not
present
or
propose
a
mode
of
action
on
bladder
carcinogenicity
for
diuron.
(
3)
The
Registrant
submitted
published
literature
in
an
attempt
to
address
the
role
of
diet
and
pH
of
the
rat
urine
for
supporting
the
mode
of
action
on
bladder
carcinogenicity
of
diuron.
The
prescreening
committee
reviewed
these
literature
reports
and
determined
that
these
reports
were
either
non
diuron
specific
or
irrelevant
to
diuron.
The
Registrant
did
not
provide
direct
evidence
to
support
a
mode
of
action
on
dietary
influence
and
high
pH
value
as
the
mechanism
on
bladder
carcinogenicity
for
diuron.
(
4)
The
Registrant
cited
a
rat
metabolism
study
on
diuron
(
HED
Doc.
No.
012408)
and
stated
that
there
are
no
common
mechanisms
among
diuron,
linuron,
and
propanil
with
regard
to
cancer
endpoints.
No
further
information
was
presented.
The
pre
screening
committee
determined
that
the
Registrant
did
not
demonstrate
a
relevance
of
the
metabolism
of
diuron
to
mode
of
action
on
bladder
carcinogenicity.
(
5)
In
1997,
the
CPRC
report
has
indicated
that
diuron
was
only
weakly
positive
(
considered
to
be
equivocal)
in
an
in
vitro
cytogenetic
study.
The
Registrant
submitted
several
reports
on
mouse
bone
marrow
micronucleus
study
to
show
that
diuron
is
non
genotoxic.
The
pre
screening
committee
referred
its
decision
to
latest
HIARC
Report
on
mutagenicity
(
HED
Doc.
No.
014657,
dated
August
28,
2001).
The
HIARC
report
stated
that
"
diuron
was
not
mutagenic
in
bacteria
or
in
cultured
mammalian
cells
and
no
indication
of
DNA
damage
in
primary
rat
hepatocytes
was
observed.
There
was
weak
evidence
of
an
in
vivo
clastogenic
response
in
Sprague
Dawley
rats
in
one
study
and
statistically
significant
increases
in
cells
with
structural
aberrations
in
a
second
study
conducted
with
the
same
rat
strain.
The
data
from
the
latter
study,
however,
were
shown
to
fall
within
the
historical
control
range."
The
pre
screening
committee
concurred
with
the
Registrant
that
there
is
little
or
no
Diuron
5
concern
on
mutagenic
activity
of
diuron.
IV.
MTARC
Conclusion
The
pre
screening
MTARC
concluded
that
the
submitted
information
is
insufficient
to
support
the
proposed
mode
of
action
on
bladder
carcinogenicity
for
diuron
at
this
time.
| epa | 2024-06-07T20:31:43.678003 | regulations | {
"license": "Public Domain",
"url": "https://downloads.regulations.gov/EPA-HQ-OPP-2002-0249-0018/content.txt"
} |
EPA-HQ-OPP-2002-0249-0019 | Supporting & Related Material | "2002-10-01T04:00:00" | null | HED
DOC.
NO.
014635
August
07,
2001
MEMORANDUM
SUBJECT:
DIURON
Report
of
the
FQPA
Safety
Factor
Committee
FROM:
Brenda
Tarplee,
Executive
Secretary
FQPA
Safety
Factor
Committee
Health
Effects
Division
(
7509C)
THROUGH:
Ed
Zager,
Chairman
FQPA
Safety
Factor
Committee
Health
Effects
Division
(
7509C)
TO:
Diana
Locke,
Risk
Assessor
Reregistration
Branch
2
Health
Effects
Division
(
7509C)
PC
Code:
035505
The
FQPA
Safety
Factor
Committee
evaluated
the
available
hazard
and
exposure
data
for
Diuron
on
June
18,
2001
and
recommended
the
FQPA
safety
factor
to
be
used
in
human
health
risk
assessments
(
as
required
by
Food
Quality
Protection
Act
of
August
3,
1996).
The
committee
concluded
that
the
FQPA
safety
factor
could
be
removed
(
1x)
in
assessing
the
risk
posed
by
this
chemical.
2
I.
HAZARD
ASSESSMENT
(
Correspondence:
Y.
Yang
to
B.
Tarplee
dated
06/
06/
01)
A.
Adequacy
of
the
Toxicology
Database
There
are
acceptable
studies
in
developmental
toxicity
study
in
rabbits
and
a
two
generation
reproduction
study
in
rats.
A
developmental
toxicity
study
in
rats
was
classified
as
unacceptable
due
to
deficiencies
in
analytical
data
on
sample
analysis;
however,
the
HIARC
considered
the
developmental
toxicity
study
in
rats
is
adequate
for
FQPA
susceptibility
assessment
based
on
the
NOAEL
of
developmental
toxicity
was
higher
than
the
maternal
NOAEL.
The
HIARC
concluded
that
a
developmental
neurotoxicity
study
with
Diuron
is
not
required.
B.
Determination
of
Susceptibility
There
is
no
indication
of
increased
susceptibility
to
young
exposed
to
Diuron
in
the
available
studies.
In
the
developmental
toxicity
study
in
rabbits,
there
were
no
developmental
effects
at
the
highest
dose
tested.
In
the
developmental
toxicity
study
in
rabbits
and
in
the
2
generation
rat
reproduction
study,
developmental
/
offspring
effects
were
observed
only
at
a
maternally
/
parentally
toxic
dose
levels.
II.
EXPOSURE
ASSESSMENTS
A.
Dietary
Food
Exposure
Considerations
(
Correspondence:
J.
Punzi
to
B.
Tarplee
dated
06/
12/
01)
Diuron
is
a
preplant,
pre
or
post
emergent
herbicide,
used
on
a
variety
of
fruits,
vegetables,
nuts,
and
field
crops.
Tolerances
are
established
for
residues
of
Diuron
in
or
on
food
commodities
at
level
ranging
from
0.1
ppm
to
7
ppm
(
40CFR
§
180.106).
The
HED
Metabolism
Assessment
Review
Committee
(
MARC)
concluded
that
for
tolerance
expression
and
risk
assessment
purposes,
the
residues
of
concern
in/
on
plants,
livestock,
and
poultry
are
diuron
and
its
metabolites
convertible
to
3,4
dichloroaniline
(
Memorandum:
J.
Punzi
to
Y.
Donovan;
dated
July
17,
2001).
USDA
Pesticide
Data
Program
(
PDP)
monitoring
data
are
available
for
Diuron,
however,
these
data
do
not
measure
3,4
DCA.
Therefore
only
field
trial
data
will
be
used
for
dietary
risk
assessment.
Additionally,
percent
crop
treated
data
are
available
from
BEAD.
The
HED
Dietary
Exposure
Evaluation
Model
(
DEEM
)
will
be
used
to
assess
the
risk
from
chronic
dietary
exposure
to
residues
in
food
resulting
from
the
use
of
Diuron
(
no
acute
endpoint
3
was
identified).
This
analysis
could
be
refined
using
the
available
percent
crop
treated
data
and
anticipated
residues
calculated
from
field
trials.
The
Committee
recognizes
that
further
refinement
to
the
dietary
food
exposure
analyses
may
be
required
as
the
risk
assessment
is
developed.
Therefore,
provided
the
final
dietary
food
exposure
assessment
does
not
underestimate
the
potential
risk
for
infants
and
children,
the
safety
factor
recommendations
of
this
Committee
stand.
B.
Dietary
Drinking
Water
Exposure
Considerations
(
Correspondence:
I.
Abdel
Saheb
to
B.
Tarplee
dated
06/
06/
01)
The
environmental
fate
database
is
adequate
to
characterize
drinking
water
exposure
for
the
parent
compound.
These
data
indicate
that
parent
Diuron
is
persistent
and
mobile.
The
only
significant
degradate
in
the
aerobic
and
anaerobic
aquatic
metabolism
studies
was
mCPDMU.
Diuron
has
the
potential
to
leach
to
ground
and
to
contaminate
surface
waters.
The
HED
MARC
concluded
that
for
risk
assessment
purposes,
the
residue
of
concern
in
drinking
water
are
parent,
DCPMU,
and
MCPDMU.
Based
on
a
structural
analogy
to
monuron,
the
MARC
recommended
that
a
separate
cancer
assessment
be
conducted
for
MCPDMU
(
Memorandum:
J.
Punzi
to
Y.
Donovan;
dated
July
17,
2001).
EFED
has
limited
monitoring
data
on
the
concentrations
of
Diuron
in
surface
water.
A
study
on
the
occurrence
of
cotton
herbicides
and
insecticides
in
Playa
lakes
of
the
high
plains
of
western
Texas
concluded
that
Diuron
was
the
major
pesticide
detected
in
water
samples
collected
from
32
lakes
(
USGS,
1992).
According
to
EFED,
even
though
the
use
of
Diuron
on
cotton
in
this
part
of
the
state
is
an
example
of
actual
use
area,
the
frequency
of
sampling
and
the
length
of
sampling
period
were
not
enough
to
represent
a
good
monitoring
data
to
be
used
for
a
regulatory
purposes.
EFED
also
has
limited
monitoring
data
on
the
concentrations
of
Diuron
in
groundwater.
The
USEPA
Pesticides
In
Groundwater
Database
(
1992)
shows
validated
monitoring
data
for
Diuron
that
are
available
for
the
states
of
California,
Florida,
Georgia,
and
Texas.
Screening
models
were
used
to
determine
estimated
concentrations
of
Diuron
in
groundwater
and
surface
water:
The
FQPA
Index
Reservoir
Screening
Tool
(
FIRST)
model
was
used
to
estimate
surface
water
concentrations
of
Diuron
from
the
use
on
citrus.
The
SCI
GROW
screening
model
was
used
to
estimate
groundwater
concentrations
of
Diuron.
The
groundwater
concentrations
estimated
from
the
modeling
agree
with
limited
existing
groundwater
monitoring
data
for
these
compounds.
4
The
Committee
recognizes
that
further
refinement
to
the
dietary
drinking
water
exposure
analyses
may
be
required
as
the
risk
assessment
is
developed.
Therefore,
provided
the
final
dietary
drinking
water
exposure
assessment
includes
all
environmental
degradates
of
toxicological
concern
and
does
not
underestimate
the
potential
risk
for
infants
and
children,
the
safety
factor
recommendations
of
this
Committee
stand.
C.
Residential
Exposure
Considerations
(
Correspondence:
R.
Sandvig
to
B.
Tarplee
dated
06/
07/
01)
Children
could
potentially
be
exposed
to
Diuron
since
it
is
used
for
weed
control
on
and
around
gravel
driveways,
patios,
and
wood
decks.
It
is
also
used
in
residential
ornamental
ponds.
There
are
no
chemical
specific
exposure
data
for
Diuron.
The
Pesticide
Handler's
Exposure
Database
(
PHED)
will
be
used
along
with
the
Outdoor
Residential
Exposure
Task
Force
(
ORETF)
database
and
the
Residential
SOPs
in
assessing
residential
risks
resulting
from
the
use
of
Diuron.
III.
SAFETY
FACTOR
RECOMMENDATION
AND
RATIONALE
A.
Recommendation
of
the
Factor
The
Committee
recommended
that
the
FQPA
safety
factor
be
removed
(
1x).
B.
Rationale
for
Removing
the
FQPA
Safety
Factor
The
Committee
concluded
that
the
safety
factor
could
be
removed
for
Diuron
because:
1.
There
is
no
indication
of
quantitative
or
qualitative
increased
susceptibility
of
rats
or
rabbits
to
in
utero
or
postnatal
exposure;
2.
A
developmental
neurotoxicity
study
(
DNT)
with
Diuron
is
not
required;
and
3.
The
dietary
(
food
and
drinking
water)
and
non
dietary
(
residential)
exposure
assessments
will
not
underestimate
the
potential
exposures
for
infants
and
children.
| epa | 2024-06-07T20:31:43.680843 | regulations | {
"license": "Public Domain",
"url": "https://downloads.regulations.gov/EPA-HQ-OPP-2002-0249-0019/content.txt"
} |
EPA-HQ-OPP-2002-0249-0020 | Supporting & Related Material | "2002-10-01T04:00:00" | null | MEMORANDUM
10
August
2001
SUBJECT:
Diuron.
Results
of
the
Health
Effects
Division
(
HED)
Metabolism
Assessment
Review
Committee
(
MARC)
Meeting
Held
on
03
JULY
2001.
Reregistration
Case
No.:
0046
PC
Code:
035505
DP
Barcode
No.:
D275688
FROM:
John
S.
Punzi,
Ph.
D.,
Chemist
Reregistration
Branch
II
Health
Effects
Division
[
7509C]
THROUGH:
Alan
Nielsen,
Branch
Senior
Scientist
Reregistration
Branch
II
Health
Effects
Division
[
7509C]
Christine
Olinger,
MARC
Chair
Health
Effects
Division
[
7509C]
TO:
Yan
W.
Donovan,
MARC
Executive
Secretary
Health
Effects
Division
[
7509C]
1.
Attendance
MARC
Members:
Alberto
Protzel,
Richard
Loranger,
Yan
Donovan,
Sheila
Piper,
Abdallah
Khasawinah,
Christine
Olinger,
David
Nixon.
Non
members
attended:
Rich
Griffin,
Ibrahim
Abdel
Saheb,
James
Jim
Breithaupt,
Sherrie
Kinard,
Carol
Christensen,
Diana
Locke,
John
Punzi.
2
MARC
Members
Absent:
William
Wassell.
MARC
Members
Absent
but
providing
comments:
John
Doherty
2.
Summary
of
Deliberations
The
metabolism
of
diuron
in
plants
and
animals
from
results
of
wheat,
corn,
orange,
ruminant,
and
poultry
studies
together
with
the
environmental
fate
studies
conducted
for
diuron
was
presented
to
the
HED
MARC
on
03/
July/
2001.
The
14C
containing
residues
that
were
identified
in
oranges
were:
diuron,
3,4
dichlorophenylurea
(
DCPU),
and
3(
3,4
dichlorophenyl)
1
methylurea
(
DCPMU)
(
Figure
1).
These
compounds
were
detected
only
in
trace
quantities
(<
0.01
0.03
ppm)
in
pulp
and
peels.
No
other
dichloroanilinecontaining
metabolites
were
identified.
The
majority
of
radioactivity
in
the
aqueous/
organic
fractions
was
characterized
as
polar
unknowns.
The
14C
containing
residues
that
were
identified
in
corn
plants
were:
Following
postemergence
treatment,
diuron
was
found
at
13.2
95.2%
of
TRR
(
0.62
1.21
ppm)
in
whole
plants,
4.1
13.1%
of
TRR
(
0.20
0.37
ppm)
in
foliage,
and
57.1
70.4%
of
TRR
(
0.04
0.22
ppm)
in
cobs;
very
minor
amounts
of
diuron
were
observed
in
kernels
(
2.4%
of
TRR,
<
0.01
ppm).
Following
preemergence
treatment,
diuron
was
detected
at
22.0
48.4%
of
TRR
(
0.22
1.15
ppm)
in
whole
plants
and
at
11%
of
TRR
(
0.35
ppm)
in
foliage;
diuron
was
not
detected
in
corn
cobs
or
kernels.
Other
residues
identified
in
corn
matrices
were
DCPMU
at
1.4
46.4%
of
TRR
(<
0.01
1.60
ppm)
and
DCPU
at
2.1
50.0%
of
TRR
(
0.02
2.22
ppm)
from
both
types
of
treatments.
No
other
metabolites
were
identified.
Polar
unknowns
accounting
for
0.5
23.6%
of
TRR
(
0.01
1.44
ppm)
in
whole
plants,
foliage,
cobs,
and
kernels
from
both
treatments
were
observed.
The
14C
containing
residues
that
were
identified
in
wheat
were:
diuron,
at
34.2
98.5%
TRR
(
0.12
80.79
ppm)
in
wheat
forage
harvested
0
71
days
posttreatment,
and
at
11.2%
TRR
(
0.002
ppm)
and
5.2%
TRR
(
0.051
ppm)
in
mature
wheat
grain
and
straw,
respectively.
The
diuron
metabolite
DCPMU
was
identified
at
7.7
25.6%
TRR
(
0.002
0.24
ppm)
in
all
wheat
commodities
except
forage
harvested
on
the
day
of
treatment,
and
DCPU
was
identified
at
1.2
34.5%
TRR
(
0.02
1.01
ppm)
in
all
wheat
commodities
except
mature
grain.
No
other
metabolites
were
identified.
Two
polar
unknowns
accounting
for
2.4
34.9%
TRR
(
0.007
0.023
ppm)
were
detected
in
wheat
forage
harvested
71
days
posttreatment
and
in
mature
grain
and
straw.
3
NH
N
O
Cl
Cl
CH
3
CH
3
NH
NH
O
Cl
Cl
CH
3
NH
NH
2
O
Cl
Cl
Diuron:
3(
3,4
dichlorophenyl)
1,1
dimethylurea
DCPMU;
IN
15654:
3(
3,4
dichlorophenyl)
1
methylurea
DCPU;
IN
R915:
3,4
dichlorophenylurea
Figure
1.
Livestock
Commodities:
The
14C
containing
residues
that
were
identified
in
lactating
goats
were:
The
principal
residue
identified
was
DCPU
which
comprised
10%
of
TRR
in
milk,
27%
of
TRR
in
fat,
35%
of
TRR
in
kidney,
23%
of
TRR
in
liver,
and
22%
of
TRR
in
muscle.
The
parent
and
other
dichloroaniline
containing
metabolites
(
i.
e.,
3,4
DCA
and
DCPMU)
were
detected
in
trace
quantities
(
#
0.01
ppm
each)
except
in
liver
(
0.12
ppm).
Four
minor
(
each
#
6%
of
TRR)
hydroxylated
metabolites
(
2
OH
DCA;
2
OH
DCPU;
2
OHDCPMU
and
N
acetyl
2
OH
DCA)
were
also
detected;
these
metabolites
were
not
observed
in
plants
and
would
not
be
determined
by
the
enforcement
method.
The
major
portion
of
radioactive
residues
in
milk
was
comprised
of
several
conjugated
polar
components
which
collectively
accounted
for
56%
of
TRR.
These
polar
components
also
accounted
for
substantial
portions
of
the
total
radioactivity
in
liver
(
collectively
25%
of
TRR
)
and
kidney
(
collectively
23%
of
TRR).
Attempts
to
further
elucidate
the
nature
of
these
polar
materials
using
various
techniques
(
e.
g.,
enzyme
digestions,
heat
treatment)
were
not
successful.
Poultry:
The
14C
containing
residues
that
were
identified
in
laying
hens
were:
DCPU,
which
comprised
-
45%
of
TRR
in
liver,
-
67
75%
of
TRR
in
muscle,
-
47%
of
TRR
in
skin
with
fat,
-
57%
of
TRR
in
egg
yolk,
and
-
54%
of
TRR
in
egg
white.
The
parent,
other
dichloroaniline
containing
metabolites
(
i.
e.,
DCPMU),
and
hydroxylated
metabolites
(
2
OH
diuron,
2
OH
DCA,
2
OH
DCPU,
2
OHDCPMU
and
N
acetyl
2
OH
DCA)
were
identified
only
in
trace
quantities
(
mostly
at
#
0.01
ppm
each).
Adequate
radiovalidation
data
were
submitted
for
the
proposed
enforcement
method
for
animal
commodities.
The
GC
method
recovered
-
86
to
>
100%
of
the
TRR
in
liver,
kidney,
and
muscle;
however,
the
method
recovered
only
10%
of
the
TRR
in
milk
and
25%
of
the
TRR
in
fat.
The
low
4
recovery
in
milk
was
previously
addressed
(
DP
Barcodes
D195058
and
D195068,
11/
30/
93,
R.
Perfetti).
It
was
concluded
that
because
the
major
portion
of
radioactive
residues
in
milk
appear
to
be
hydroxy
metabolites
which
cannot
be
converted
to
DCA
and
do
need
not
be
quantitated,
a
new
method
would
not
be
required
for
milk.
Instead,
it
was
determined
that
the
levels
of
diuron
residues
in
milk
identified
in
the
ruminant
feeding
study
would
be
multiplied
by
10
to
account
for
all
of
the
exposure
in
the
risk
assessment.
The
low
recovery
in
fat
was
most
likely
due
to
the
low
residue
levels
present
in
fat.
In
a
separate
radiovalidation
study,
the
GC
method
recovered
-
62
to
77%
of
the
TRR
in
poultry
liver
and
muscle,
and
58
to
65%
of
the
TRR
in
egg
whites
and
yolks.
Dietary
Water
The
environmental
data
base
is
complete,
diuron
is
persistent
in
the
environment
and
has
potential
for
leaching
to
ground
and
surface
water.
The
metabolism
studies
of
diuron
in
a
variety
of
environmental
conditions
demonstrate
that
monochlorinated
methylphenyl
urea
(
MCMPU)
and
monochlorinated
dimethylphenyl
urea
(
MCDMPU)
can
be
formed
under
some
conditions
and
that
MCDMPU
is
a
major
degredate
in
aquatic
aeobic
and
anerobic
studies.
DCPMU
was
identified
as
a
major
degradate
in
several
studies
and
3,4
DCA,
DCMU,
PDMU
were
identified
as
minor
metabolites.
The
MARC
raised
concerns
for
MCPDMU
based
on
an
analogous
compound,
monuron.
With
the
exception
of
the
position
of
the
chlorine,
the
structures
are
identical.
There
are
cancer
concerns
for
monuron
but
the
target
organs
are
different
than
those
effected
by
diuron.
The
MARC
recommended
that
a
separate
cancer
assessment
be
conducted
for
MCPDMU..
MARC
Decisions
&
Rationale
Plants:
The
MARC
concluded
that
for
tolerance
expression
and
risk
assessment
purposes,
the
residues
of
concern
in/
on
plants
are
diuron
and
its
metabolites
convertible
to
3,4
dichloroaniline.
This
decision
was
based
on
the
assumption
that
the
metabolites
DCPMU,
and
DCPU
would
not
be
any
more
or
less
toxic
than
the
parent
and
in
consideration
of
the
analytical
methods
used
to
collect
field
trial
data
which
are
not
capable
of
measuring
each
metabolite
individually.
3,4
Dichloroaniline
is
not
of
toxicological
concern
for
the
endpoints
regulated
for
diuron,
but
methods
specific
for
diuron,
DCPMU,
and
DCPU
are
not
widely
employed.
.
Livestock
Commodities:
The
MARC
concluded
that
for
the
tolerance
expression
and
risk
assessment
purposes,
the
residues
of
concern
in/
on
livestock
and
poultry
are
diuron
and
its
metabolites
convertible
to
3,
4
dichloroaniline.
This
decision
was
based
on
the
5
assumption
that
the
metabolites
DCPMU
and
DCPU
would
not
be
any
more
or
less
toxic
than
the
parent
and
in
consideration
the
analytical
methods
used
to
collect
field
trial
data
which
are
not
capable
of
measuring
each
metabolite
individually.
To
account
for
the
poor
recovery
of
hydroxylated
metabolites
from
milk,
it
was
determined
that
the
levels
of
diuron
residues
in
milk
identified
in
the
ruminant
feeding
study
would
be
multiplied
by
10
to
account
for
all
of
the
exposure
to
diuron
related
residues
in
the
risk
assessment.
Drinking
Water:
The
MARC
concluded
that
for
risk
assessment
purposes,
the
residues
of
concern
in
drinking
water
are
parent,
DCPMU,
and
MCPDMU.
Based
on
a
structural
analogy
to
monuron,
the
MARC
recommended
that
a
separate
cancer
assessment
be
conducted
for
MCPDMU.
cc:
JSPunzi
(
RRB2),
D.
Locke
(
RRB2),
Diuron
Reg.
Std.
File,
Diuron
SF,
RF,
LAN.
RD/
I:
RRB2
Chem
Review
Team
(
07/
11/
2001),
Alan
Nielsen
(
08/
31/
2001),
MARC
Chair
(
07/
11/
2001).
John
S.
Punzi:
7509C:
RRB2:
CM2:
Rm
712M:
703
305
7727:
07/
11/
2001.
| epa | 2024-06-07T20:31:43.683749 | regulations | {
"license": "Public Domain",
"url": "https://downloads.regulations.gov/EPA-HQ-OPP-2002-0249-0020/content.txt"
} |
EPA-HQ-OPP-2002-0249-0021 | Supporting & Related Material | "2002-10-01T04:00:00" | null | MEMORANDUM
July
5,
2001
SUBJECT:
MONURON:
Quantitative
Risk
Assessment
(
Q1*)
Based
On
F344/
N
Rat
Dietary
Study
With
3/
4'
s
Interspecies
Scaling
Factor,
P.
C.
Code
035501
TO:
Guruva
Reddy,
Veterinary
Medical
Officer
Registration
Action
Branch
1
Health
Effects
Division
(
7509C)
FROM:
Lori
L.
Brunsman,
Statistician
Science
Information
Management
Branch
Health
Effects
Division
(
7509C)
THROUGH:
Jess
Rowland,
Branch
Chief
Science
Information
Management
Branch
Health
Effects
Division
(
7509C)
Conclusion
The
most
potent
unit
risk,
Q1*(
mg/
kg/
day)
1,
of
those
calculated
for
Monuron
is
that
for
male
rat
liver
neoplastic
nodule
and/
or
carcinoma
combined
tumor
rates
at
1.52
x
10
2
in
human
equivalents.
The
dose
levels
used
from
the
104
week
dietary
study
were
0,
750
and
1500
ppm
of
Monuron.
The
corresponding
tumor
rates
were
1/
50,
6/
49,
and
9/
50,
respectively.
Background
Quantifications
of
risk
have
subsequently
been
estimated
for
male
rat
liver
and
kidney
tumors.
The
most
potent
unit
risk
will
be
used
for
the
purpose
of
lifetime
cancer
risk
assessment
by
the
Agency.
In
this
case,
the
most
potent
unit
risk,
Q1*,
is
that
for
male
rat
liver
neoplastic
nodule
and/
or
carcinoma
combined
tumor
rates
at
1.52
x
10
2
in
human
equivalents.
All
unit
risks
have
been
converted
from
animals
to
humans
by
use
of
the
3/
4'
s
scaling
factor
(
Tox_
Risk
program,
Version
3.5,
K.
Crump,
1994)
1.
For
the
conversion
to
human
equivalents,
weights
of
0.35
kg
for
the
rat,
70
kg
for
humans,
and
the
use
of
104
weeks
for
the
rat
life
span
default
were
used.
It
is
to
be
noted
that
the
Q1*
(
mg/
kg/
day)
1
is
an
estimate
of
the
upper
bound
on
risk
and
that,
as
stated
in
the
EPA
Risk
Assessment
Guidelines,
the
true
value
of
the
risk
is
unknown,
and
may
be
as
low
as
zero.
Dose
Response
Analysis
The
study
indicated
survival
rates
of
male
rats
of
the
high
dose
group
to
be
increased
relative
to
the
controls,
but
the
actual
statistical
significance
of
mortality
could
not
be
determined
due
to
lack
of
individual
animal
data.
These
unit
risks,
Q1*>
s,
were
obtained
by
the
application
of
the
Multi
Stage
model
(
Tox_
Risk
program,
Version
3.5,
K.
Crump,
1994).
Male
rats
had
a
significant
increasing
trend,
and
a
significant
difference
in
the
pairwise
comparison
of
the
1500
ppm
dose
group
with
the
controls,
for
liver
neoplastic
nodules
and/
or
carcinomas
combined,
both
at
p
<
0.01.
Additional
Q1*
Calculations
The
unit
risk,
Q1*(
mg/
kg/
day)
1,
of
Monuron
based
upon
male
rat
liver
neoplastic
nodule
tumor
rates
is
1.31
x
10
2
in
human
equivalents.
The
dose
levels
used
from
the
104
week
dietary
study
were
0,
750
and
1500
ppm
of
Monuron.
The
corresponding
tumor
rates
were
1/
50,
6/
49,
and
7/
50,
respectively.
The
unit
risk,
Q1*(
mg/
kg/
day)
1,
of
Monuron
based
upon
male
rat
kidney
renal
tubular
cell
adenoma
and/
or
adenocarcinoma
tumor
rates
is
1.30
x
10
2
in
human
equivalents.
The
dose
levels
used
from
the
104
week
dietary
study
were
0,
750
and
1500
ppm
of
Monuron.
The
corresponding
tumor
rates
were
0/
50,
3/
50,
and
15/
50,
respectively.
The
unit
risk,
Q1*(
mg/
kg/
day)
1,
of
Monuron
based
upon
male
rat
kidney
renal
tubular
cell
adenocarcinoma
tumor
rates
is
8.22
x
10
3
in
human
equivalents.
The
dose
levels
used
from
the
104
week
dietary
study
were
0,
750
and
1500
ppm
of
Monuron.
The
corresponding
tumor
rates
were
0/
50,
1/
50,
and
8/
50,
respectively.
The
unit
risk,
Q1*(
mg/
kg/
day)
1,
of
Monuron
based
upon
male
rat
kidney
renal
tubular
cell
adenoma
tumor
rates
is
9.91
x
10
3
in
human
equivalents.
The
dose
levels
used
from
the
104
week
dietary
study
were
0,
750
and
1500
ppm
of
Monuron.
The
corresponding
tumor
rates
were
0/
50,
2/
50,
and
7/
50,
respectively.
1See
memo
Deriving
Q1*
s
Using
the
Unified
Interspecies
Scaling
Factor,
P.
A.
Fenner
Crisp,
Director,
HED,
7/
1/
94.
| epa | 2024-06-07T20:31:43.687300 | regulations | {
"license": "Public Domain",
"url": "https://downloads.regulations.gov/EPA-HQ-OPP-2002-0249-0021/content.txt"
} |
EPA-HQ-OPP-2002-0249-0022 | Supporting & Related Material | "2002-10-01T04:00:00" | null | UNITED
STATES
ENVIRONMENTAL
PROTECTION
AGENCY
WASHINGTON,
D.
C.
20460
OFFICE
OF
PREVENTION,
PESTICIDES
AND
TOXIC
SUBSTANCES
August
8,2001
MEMORANDUM
SUBJECT:
Review
of
Diuron
Poisoning
Incident
Data
Chemical:
#
035505
FROM:
Ruth
H.
Allen,
Ph.
D.,
M.
P.
H.,
Environmental
Epidemiologist
Chemistry
and
Exposure
Branch
Health
Effects
Division
(
7509C)
THROUGH:
Francis
B.
Suhre,
Senior
Scientist
Chemistry
and
Exposure
Branch
1
Health
Effects
Division
(
7509C)
TO:
Diana
Locke,
Risk
Assessor
Reregistration
Branch
2
Health
Effects
Division
(
7509C)
BACKGROUND
In
response
to
the
request
that
Health
Effects
Division
Epidemiology
Group
review
the
incident
data
on
diuron,
the
following
data
bases
were
reviewed
for
the
poisoning
incident
data
on
the
active
ingredient
cacodylic
acid.
1)
OPP
Incident
Data
System
(
IDS)
reports
of
incidents
from
various
sources,
including
required
Federal
Insecticide
Fungicide
and
Rodenticide
Act
(
FIFRA)
Section
6
(
a)
(
2)
registrants,
other
federal
and
state
health
and
environmental
agencies
and
individual
consumers,
submitted
to
OPP
since
1992.
Reports
submitted
to
the
Incident
Data
System
represent
anecdotal
reports
or
allegations
only,
unless
otherwise
stated.
Typically
no
conclusions
can
be
drawn
implicating
the
pesticide
as
a
cause
of
any
of
the
reported
health
effects.
Nevertheless,
sometimes
with
enough
cases
and/
or
enough
documentation
risk
mitigation
measures
may
be
suggested.
2)
American
Association
of
Poison
Control
Centers
(
AAPCC)
as
the
result
of
Data
Call
Ins
issued
in
1993,
OPP
received
Poison
Control
2
Center
data
covering
the
years
1985
through
1992
for
28
organophosphate
and
carbamate
chemicals.
Most
of
the
national
Poison
Control
Centers
(
PCCs)
participate
in
a
national
data
collection
system,
the
Toxic
Exposure
Surveillance
System
which
obtains
data
from
about
70
centers
at
hospitals
and
universities.
PCCs
provide
telephone
consultation
for
individuals
and
health
care
providers
on
suspected
poisonings,
involving
drugs,
household
products,
pesticides,
etc.
3)
California
Department
of
Food
and
Agriculture
(
replaced
by
the
Department
of
Pesticide
Regulation
in
1991)
California
has
collected
uniform
data
on
suspected
pesticide
poisonings
since
1982.
Physicians
are
required,
by
statute,
to
report
to
their
local
health
officer
all
occurrences
of
illness
suspected
of
being
related
to
exposure
to
pesticides.
The
majority
of
the
incidents
involve
workers.
Information
on
exposure
(
worker
activity),
type
of
illness
(
systemic,
eye,
skin,
eye/
skin
and
respiratory),
likelihood
of
a
causal
relationship,
and
number
of
days
off
work
and
in
the
hospital
are
provided.
4)
National
Pesticide
Telecommunications
Network
(
NPTN)
NPTN
is
a
toll
free
information
service
supported
by
OPP.
A
ranking
of
the
top
200
active
ingredients
for
which
telephone
calls
were
received
during
calendar
years
1984
1991,
inclusive
has
been
prepared.
The
total
number
of
calls
was
tabulated
for
the
categories
human
incidents,
animal
incidents,
calls
for
information,
and
others.
DIURON
REVIEW
I.
Incident
Data
System(
IDS)
II.
American
Association
of
Poison
Control
Centers
(
AAPCC)
For
the
reporting
period
1993
1996,
III.
California
Pesticide
Illness
Surveillance
Program
Case
reports
are
described
in
investigation
by
the
Worker
Health
and
Safety
Branch
or
the
Department
of
Pesticide
Regulations
of
the
California
Environmental
Protection
Agency.
IV.
National
Pesticide
Telecommunication
Network
(
NPTN)
In
the
1984
1991
inclusive
NPTN
ranking
of
the
top
200
active
| epa | 2024-06-07T20:31:43.690183 | regulations | {
"license": "Public Domain",
"url": "https://downloads.regulations.gov/EPA-HQ-OPP-2002-0249-0022/content.txt"
} |
EPA-HQ-OPP-2002-0249-0023 | Supporting & Related Material | "2002-10-01T04:00:00" | null | Subject:
Diuron
Revised
Q1*,
(
3/
4'
s
Interspecies
Scaling
Factor),
1985
Wistar
Rat
2
Year
Dietary
Study
PC
035505
From:
Bernice
Fisher,
Biostatistician
Statistics
Section
Science
Analysis
Branch/
HED
(
7509C)
To:
Linda
Taylor,
Ph.
D,
Pharmacologist
Review
Section
II
Toxicology
Branch
II/
HED
(
7509C)
Thru:
Hugh
M.
Pettigrew,
PhD.,
Section
Head
Statistics
Section
Science
Analysis
Branch/
HED
(
7509C)
The
revised
unit
risk,
Q1*(
mg/
kg/
day)
1
of
Diuron,
based
upon
male
rat
urinary
bladder
carcinomas
is
1.91x10
2
in
human
equivalents
(
converted
from
animals
to
humans
by
use
of
the
3/
4'
s
scaling
factor
1994,
Tox_
Risk,
3.5
K.
Crump)
a.
The
dose
levels
used
in
the
Wistar
rat
dietary
study
(
1985
Bayer
AG
T
8010647)
were
0,
25,
250
and
2500
ppm
of
Diuron.
The
corresponding
tumor
rates
in
male
rats
were
1/
49,
0/
50,
1/
49
and
35/
48
respectively.
These
doses
and
rates
were
obtained
from
the
memorandum
by
L.
L.
Brunsman
Diuron
Qualitative
Risk
Assessment
Based
on
Wistar
Rat
and
NMRI(
SPF
Han)
Mouse
Dietary
Studies,
November
11,1996.
a
See
Memo
Deriving
Q1*
s
Using
the
Unified
Interspecies
Scaling
Factor,
P.
A.
Fenner
Crisp,
Director
HED,
7/
1/
94.
cc:
Caswell
file
M.
Metzger
E.
Waldman
B.
Doyle
C.
Scheltema
L.
Nisenson
Background
The
Health
Effects
Division
Carcinogenicity
Peer
Review
Committee,
December
18,
1996
recommended
that
the
estimate
of
unit
risk
should
be
based
on
male
Wistar
rat
carcinomas
in
the
urinary
bladder.
Dose
Response
Analysis
Since
mortality
was
not
affected
differentially
with
increasing
doses
of
Diuron,
the
estimate
of
the
unit
risk,
Q1*
in
human
equivalents
was
obtained
by
the
application
of
the
Multi
Stage
model(
Tox_
Risk
program,
version
3.5
K.
Crump).
The
estimate
of
unit
risk,
Q1*,
was
based
upon
the
urinary
bladder
carcinomas
in
male
rats.
For
the
conversion
to
human
equivalents,
weights
of
.40
kg
for
the
males
and
70
kg
for
humans
and
the
3/
4'
s
scaling
factor
were
used.
It
is
to
be
noted
that
Q1*
(
mg/
kg/
day)
1
is
an
estimate
of
the
upper
bound
on
risk
and
that
(
as
stated
in
the
EPA
Risk
Assessment
Guidelines)
"
the
true
value
of
the
risk
is
unknown,
and
may
be
as
l
| epa | 2024-06-07T20:31:43.693027 | regulations | {
"license": "Public Domain",
"url": "https://downloads.regulations.gov/EPA-HQ-OPP-2002-0249-0023/content.txt"
} |
EPA-HQ-OPP-2002-0249-0024 | Supporting & Related Material | "2002-10-01T04:00:00" | null | March
13,
2002
MEMORANDUM:
Response
to
Comment
Document
Phase
2
DIURON:
The
HED
Chapter
of
the
Reregistration
Eligibility
Decision
PC
Code
(
035505).
Case
0046.
DP
Barcode
D281396
FROM:
Carol
Christensen,
Risk
Assessor
Reregistration
Branch
II
Health
Effects
Division
(
7509C)
THRU:
Alan
Nielsen,
Branch
Senior
Scientist
Reregistration
Branch
II
Health
Effects
Division
(
7509C)
TO:
Richard
Dumas
Team
Leader
Reregistration
Branch
II
Special
Review
and
Reregistration
Division
(
7508W)
The
attached
document
was
generated
in
response
to
the
comments
received
from
the
Diuron
registrant
Griffin
Chemical
on
February
12th,
2002.
This
document
was
generated
as
part
of
Phase
2
(
error
only)
of
the
Interim
Public
Participation
Process.
The
comments
pertain
to
the
3(
3,4
dichlorophenyl)
1,1
dimethylurea
(
diuron)
RED
document
dated
December
13,
2002.
HED
has
acknowledged
these
comments
in
the
Response
to
Comment
document
as
well
as
in
an
updated
version
of
the
HED
Chapter
of
the
Diuron
RED
document
and
the
Diuron
Toxicology
Chapter.
The
responses
documented
here
reflect
the
Agency's
current
guidelines
and
policies
concerning
risk
assessment.
This
document
and
updated
HED
chapters
includes
replies
from
John
Punzi
on
residue
chemistry
and
dietary
risk
assessment,
Yung
Yang
concerning
toxicology
comments,
and
occupational
and
residential
exposure
responses
from
Renee
Sandvig
and
Christina
Jarvis,
as
well
as
risk
assessment
and
characterization
corrections
by
Carol
Christensen.
The
Environmental
Fate
and
Effects
Division
(
EFED)
revised
the
drinking
water
exposure
assessment
based
upon
Registrant
comments.
The
new
memorandum
entitled
"
Drinking
Water
Reassessment
for
Diuron
and
its
Degradates"
dated
March
11,
2002
has
been
incorporated
into
the
Revised
HED
Chapter
of
the
Reregistration
Eligibility
Decision
Document
(
RED)
as
appropriate.
Specific
comments
pertaining
to
the
Drinking
Water
Exposure
Assessment
for
Diuron
and
its
Degradates
2
are
completed
under
a
separate
memo.
HED's
Response
to
Registrant's
Phase
1
Error
Only
Comments
I.
Toxicology
Disciplinary
Chapter
Page
4.
1.0
Hazard
Characterization:
Para
1,
Line
3.
However,
a
new
28
day
inhalation
toxicity
study
has
been
required
to
provide
better
hazard
characterization.
Registrant's
Comment:
Although
inhalation
studies
are
preferred
for
the
assessment
of
inhalation
hazard,
there
is
no
triggering
for
a
28
day
inhalation
as
outlined
in
the
40CFR
regulation.
The
acute
inhalation
study
shows
no
inhalation
toxicity.
The
limit
test
showed
no
inhalation
toxicity.
There
is
no
volatility
of
the
diuron
either
as
a
solid
formulation
or
as
a
liquid
formulation.
The
use
pattern
does
not
suggest
a
particular
inhalation
risk
to
mixers
or
applicators.
No
use
exceeds
the
short
term
inhalation
designation
of
1
30
days.
Based
on
the
regulations,
there
must
be
a
mistake
in
this
requirement.
It
was
not
triggered.
HED's
Response:
This
is
a
policy
issue
and
will
be
addressed
in
the
phase
4
period.
Page
4.
1.0
Hazard
Characterization:
Para
3,
Line
5.
Consistent
observations
of
erythrocyte
regeneration
are
seen
in
chronic
toxicity
studies
in
rats,
mice
and
dogs.
Registrant's
Comment:
This
implies
incorrectly
that
the
mice
and
dogs
responded
in
a
similar
manner.
The
dose
that
resulted
in
similar
effects
was
at
substantially
higher
dosages
of
diuron.
The
phrase
should
be
added
for
correctness,
"
chronic
toxicity
studies
in
rats,
mice
and
dogs
but
at
significantly
higher
dosages
of
diuron
than
seen
in
the
rat
chronic
study."
HED's
Response:
Hematological
effects
have
been
consistently
observed
in
the
rat,
dog,
and
mouse
chronic
toxicity
studies.
No
change
is
necessary.
Page
4.
1.0
Hazard
Characterization:
Para
6,
Line
2.
Classified
as
"
known/
likely"
human
carcinogen
by
all
routes,
based
on
urinary
bladder .
Registrant's
Comment:
Data
is
only
for
the
oral
route.
No
studies
were
done
to
demonstrate
that
tumors
resulted
by
other
routes.
The
mechanism
of
action
of
diuron
is
specific
for
the
oral
route.
Because
the
studies
using
other
routes
of
exposure
have
not
been
done,
other
routes
cannot
be
excluded
at
this
time.
However,
for
correctness
the
phase
"
by
oral
route
only"
needs
to
be
added
to
the
end
of
the
sentence.
It
should
read,
"
in
the
female
NMRI
mouse
by
oral
routes
only."
HED's
Response:
The
sentence
is
revised
to
"
Classified
as
"
known/
likely"
human
carcinogen
based
on
urinary
bladder
......"
Page
5.
1.0
Hazard
Characterization:
Para
1
(
cont.),
Line
1.
There
is
no
additional
information
to
justify
a
reclassification
of
the
cancer
classification
for
diuron
at
this
time.
3
Registrant's
Comment:
This
statement
was
made
based
on
a
review
of
the
mechanistic
white
paper
that
the
MTARC
concluded
the
"
information
was
insufficient
to
support
a
mode
of
action
on
bladder
carcinogenicity."
However,
one
of
the
reasons
that
diuron
was
considered
as
a
`
known'
carcinogen
was
based
on
potential
genotoxicity.
Rereview
of
the
mouse
bone
marrow
chromosomal
aberration
study
changed
the
conclusion
of
the
study
from
positive
to
negative
based
on
a
review
of
the
historical
background
data
from
the
performing
laboratory.
This
was
the
only
positive
genotoxicity
result,
but
it
carried
much
weight
in
the
deliberation
of
the
cancer
classification
of
diuron.
The
change
in
the
classification
of
diuron
as
a
mutagen
to
a
non
mutagen
is,
in
fact,
new
information
that
was
not
considered.
The
last
sentence
either
needs
to
be
deleted
or
should
simply
state
"
Diuron
will
not
be
reclassified
at
this
time."
HED's
Response:
The
sentence
is
revised
to
"
Diuron
will
not
be
re
classified
at
this
time."
Page
6.
Requirement
870.3465:
90
day
Inhalation.
The
HIARC
determined
that
a
28
day
inhalation
toxicity
is
required.
Registrant's
Comment:
According
to
Section
158.340
of
the
40CFR,
a
90
day
inhalation
rat
study
is
conditionally
required.
Footnote
6
of
the
Toxicology
Data
Requirements
states,
"
Required
if
use
may
result
in
repeated
inhalation
exposure
at
a
concentration
likely
to
be
toxic.
A
test
with
duration
21
days
is
required
if
the
pesticide
is
used
on
tobacco."
The
following
agricultural
use
parameters
were
presented
at
the
SMART
meeting
held
on
May
3,
2001.
Table
1.
Diuron
Agricultural
Use
Parameters
Agricultural
Acreage
Treated
Per
Applicator
Unit
Application
Max
Acres/
Day
Max
Acre
Apps/
Year
(
Season)
On
Farm
Non
Specialized
Ground
150
3000
On
Farm
Specialized
Ground
800
6000
Custom
Ground
800
12000
Custom
Aerial
1200
30000
Even
in
the
worst
case
represented
by
aerial
application,
the
maximum
acre
application
per
year
averages
to
only
25
days
of
application.
Diuron
is
a
pre
emergent
herbicide.
There
is
a
small
window
between
when
the
crop
is
planted
and
when
the
seed
emerges
in
which
the
field
is
treated
to
kill
weeds
that
emerge
before
the
crop.
The
Occupational
and
Residential
Exposure
Assessment
assumes
10
days
of
exposure
for
a
private
farmer
and
30
days
of
exposure
for
a
commercial
applicator
in
a
few
large
acreage
crops.
Therefore,
no
use
exceeds
the
short
term
inhalation
designation
of
1
30
days.
Diuron
is
not
a
volatile
chemical
either
as
a
TGAI
or
as
a
TEP.
Given
the
physical
characteristics
of
the
TEPs,
there
should
be
no
respirable
particles
generated
in
the
mixing,
loading
and
application
of
the
product.
Secondly,
based
on
the
inhalation
data
from
the
acute
study,
there
is
no
reason
to
believe
that
the
concentration
of
diuron
in
the
spray
mix
is
likely
to
be
toxic.
The
LD50
in
this
study
was
7.1
mg/
L.
There
is
no
trigger
to
require
this
study
for
this
type
of
product.
Therefore,
the
requirement
for
a
28
day
inhalation
study
on
diuron
must
be
in
error.
4
HED's
Response:
This
is
a
policy
issue
and
will
be
addressed
in
the
phase
4
period.
Page
7.
4.2
Subchronic
Toxicity:
Para
1,
Line
3.
Registrant's
Comment:
The
28
day
inhalation
study
requirement
should
be
conditional
according
to
the
40CFR.
Diuron
does
not
meet
the
triggers
for
such
a
study.
See
discussion
above.
HED's
Response:
This
is
a
policy
issue
and
will
be
addressed
in
the
phase
4
period.
Page
8.
Requirement
870.3100:
90
Day
Oral
Toxicity
Rat,
Para
3.
General
Reticulocyte
counts
in
the
high
dose
females
were
increased
at
all
intervals
with
statistical
significance
(
p<
0.05)
attained
at
weeks
12
and
26
(
150
165%
of
control
values).
Mean
hemoglobin
concentrations
in
the
high
dose
females
were
slightly
(
n.
s.)
depressed
at
all
intervals
as
compared
to
the
controls
(
within
5%
of
control
levels).
Registrant's
Comment:
Although
the
high
dose
females
show
increased
reticulocyte
counts,
all
except
for
the
3
month
interval
are
within
the
control
values
for
the
study.
The
female
control
values
range
from
12
17.
Historically
in
the
conducting
laboratory,
the
1985
results
show
control
animals
to
range
between
0
34
in
reticulocyte
counts
(
attached).
The
values
of
28
at
the
3
month
interval
of
the
25
ppm
dosed
females
and
the
value
of
18
at
the
6
month
interval
of
the
25
ppm
dosed
females
are
well
within
the
expected
values
observed
in
the
performing
laboratory
during
the
time
period
in
which
the
study
was
conducted.
Thus,
despite
statistical
significance,
there
is
little
biological
significance
to
the
increase
in
reticulocyte
counts
at
the
25
ppm
dose
level
in
the
female
rats.
The
same
is
true
of
the
nonstatistically
increased
(<
5%)
hemoglobin
concentration.
By
discussing
the
statistical
significance
apart
from
the
biological
significance,
it
would
appear
that
the
effects
as
delineated
by
the
statement
in
paragraph
3
have
relevance
to
the
assessment.
HED's
Response:
The
hematological
effects
are
consistently
observed
in
other
studies
and
are
considered
biologically
significant.
No
change
is
necessary.
Page
8.
Requirement
870.3100:
90
Day
Oral
Toxicity
Rat,
Para
4,
5.
General
Increased
incidences
of
gross
lesions
on
the
urinary
bladder .
Microscopic
examination
and
morphometric
measurements
of
the
urinary
bladder
...
.
Registrant's
Comment:
The
discussion
in
these
two
paragraphs
misrepresents
the
conclusions
of
the
study
authors.
The
effects
as
described
were
noted
in
the
treated
groups
and
not
in
the
controls.
However,
a
closer
examination
of
the
incidences
in
both
males
and
females
demonstrate
little
dose
response
relationship.
On
page
15
of
the
study
report
the
authors
state:
"
The
following
alterations
were
noted
at
autopsy
at
the
end
of
study.
Part
of
the
animals'
urinary
bladder
walls
exhibited
dilation
of
blood
vessels,
increased
consistency
before
filling
with
the
fixative
or
reduced
transparency
after
filling
with
fixative.
These
findings
were
mostly
noted
only
in
the
treated
animals,
more
frequently
in
the
females
than
the
males."
Microscopic
examinations
were
also
made.
It
was
determined
that
2
low
dose
females
and
1
high
dose
female
showed
focal
hyperplasia.
The
degree
of
severity
was
1
(
slight)
5
on
a
scale
of
1
to
5.
One
low
dose
male
and
1
control
female
and
1
high
dose
female
showed
simple
hyperplasia
again
scored
as
1
or
slight
on
the
severity
scale.
One
low
dose
female
displayed
simple
hyperplasia
with
some
vascularization;
the
added
vascularization
pushed
the
severity
score
to
2
or
slight
to
moderate.
Two
low
dose
males
and
1
high
dose
male
showed
a
thickening
of
the
epithelial
cells
but
involved
less
than
three
cell
layers;
severity
score
of
1
or
slight.
There
is
no
dose
response
and
the
severity
of
the
lesions
are
slight
in
all
cases.
The
microscopic
observations
did
not
correlate
with
the
gross
findings.
On
the
basis
of
these
conflicting
qualitative
observations,
the
authors
decide
to
make
quantitative
measurements
of
the
bladder
wall
thickness.
They
measured
only
females
because
there
were
no
effects
that
differed
from
the
controls
in
the
males.
They
state
in
the
methods
section
on
page
7
of
the
report:
Gross
findings
made
in
particular
in
treated
females
indicated
possible
thickening
of
the
urinary
bladder
walls.
For
this
reason
the
thickness
of
all
the
females'
bladder
walls
was
quantitatively
measured
with
an
automatic
Omnicon
screen
unit
(
Bausch
&
Lomb
Co.).
Equally
long
paramedian
areas
of
the
two
wall
portions
of
each
bladder
half
were
measured,
that
is
four
measurements
per
animal.
The
area
contained
a
wall
portion
including
epithelium
and
peritoneal
tissue."
The
results
were
clear.
There
was
no
thickening
of
the
bladder
walls.
This
can
be
seen
in
Table
2
below
as
taken
from
the
study
report
on
page
17.
Table
2.
Females'
relative
bladder
wall
areas.
Mean
figures
per
group
on
measurement
of
4
area
portions
of
some
length
per
animal
(
area
=
paramedian
bladder
wall
section).
Dose
(
ppm)
0
4
10
25
Mean
437
492
448
486
Std
Deviation
58
80
50
51
Based
on
the
wide
variation
and
absence
of
dose
response
relationship,
no
differences
were
assessed
to
these
findings.
The
authors
conclude
on
page
17
of
the
study
report:
The
gross
findings
obtained
for
the
urinary
bladders
(
see
Section
5.7)
did
not
correlate
with
the
histopathological
results.
In
an
attempt
to
obtain
correlation
for
the
reduced
transparency
and
increased
consistency
of
the
bladder
walls,
automatic
measurements
of
the
bladder
wall
thickness
were
made.
The
results
of
these
measurements
are
compiled
in
Table
5
(
given
here
as
Table
2).
In
consideration
of
the
wide
variation
and
absence
of
dose
correlation,
no
major
differences
were
noted
between
the
figures
in
any
of
the
groups.
No
importance
is
therefore
attached
to
the
gross
findings.
These
observations
are
NOT
EQUIVOCAL.
There
are
no
effects
that
can
be
attributed
to
any
dose
level,
let
alone
the
low
dose
of
4
ppm.
The
NOEL
for
this
study
can
be
defined
by
the
blood
effects
for
which
the
study
was
designed.
HED's
Response:
This
nonguideline
study
was
conducted
in
1988
and
reviewed
by
the
HED
in
1990.
The
scope
of
the
study
was
primarily
restricted
to
parameters
associated
6
with
effects
on
erythrocytes.
However,
the
study
did
not
evaluate
the
status
of
the
bone
marrow.
Gross
macroscopic
observations
revealed
an
increase
of
urinary
bladder
incidences
related
to
blood
vessel
dilation,
and
reduced
transparency
and
increased
firmness
in
all
treated
groups
as
compared
to
the
control.
Quantitative
evaluation
of
the
urinary
bladder
wall
revealed
a
slight
increase
of
urinary
wall
thickening
in
all
treated
females
as
compared
to
the
controls.
Males
were
not
evaluated
in
this
study.
In
a
chronic
toxicity
study
(
MRID
40886501)
(
dose
levels
of
0,
25,
250,
or
2500
ppm),
a
treatment
related
urinary
bladder
thickening
was
observed
in
the
25
ppm
males.
The
HED
reviewer
concluded
that
a
NOAEL
could
not
be
determined
because
many
parameters
were
not
evaluated
in
this
study.
No
change
is
necessary.
Page
8.
Requirement
870.3100:
90
Day
Oral
Toxicity
Rat,
Para
3,
Line
2.
Specific
Mean
hemoglobin
concentrations
in
the
high
dose
females
were
slightly
(
n.
s.)
depressed
at
all
intervals
as
compared
to
the
controls
(
within
5%
of
the
control
levels).
Registrant's
Comment:
This
sentence
either
needs
to
be
deleted
or
it
needs
to
be
made
clear
that
this
is
not
an
effect
as
there
is
neither
biological
nor
statistical
significance
in
this
finding.
HED's
Response:
By
the
weight
of
evidence,
these
hematological
effects
are
considered
biologically
significant.
No
change
is
necessary.
Page
8.
Requirement
870.3100:
90
Day
Oral
Toxicity
Rat,
Para
5,
Line
2.
Specific
Hyperplasia
of
the
epithelium
was
observed
in
1
low
dose
male,
1
control
female,
2
low
dose
females
and
2
high
dose
females.
Registrant's
Comment:
When
the
focal
hyperplasia
is
separate
from
the
totals
as
given
in
the
EPA
document,
there
is
clearly
no
statistically
significant
hyperplasia
at
any
dose
level.
Focal
hyperplasia
is
given
as
2
females
at
the
low
and
1
female
at
the
high
dose.
Control
and
high
dose
females
(
one
each)
demonstrate
simple
hyperplasia
(
nonfocal
Secondly,
the
degree
of
hyperplasia
is
given
as
the
lowest
scored.
Severity
is
not
discussed.
It
needs
to
be
as
it
impacts
the
`
equivocal'
judgment
of
the
effect.
The
dose
response
needs
to
be
addressed.
The
lack
of
a
dose
correlation
is
omitted.
It
too
impacts
the
`
equivocal'
judgment
of
the
effect.
Also
omitted
is
the
lack
of
correlation
between
the
gross
examination
results
and
the
histopathological
results.
It
was
this
discordance
that
prompted
the
quantitative
measurements
of
the
female
bladders.
These
are
all
errors
of
omission
that
impact
the
assessment
of
the
effect.
HED's
Response:
See
above
HED's
response.
Page
8.
Requirement
870.3100:
90
Day
Oral
Toxicity
Rat,
Para
5,
Line
7
(
last).
These
observations
are
judged
to
be
equivocal.
Registrant's
Comment:
The
effects
are
not
equivocal;
there
are
no
effects.
No
dose
response
was
observed,
no
thickening
of
the
bladder
as
demonstrated
by
either
quantitative
measurement
or
a
correlation
between
gross
observation
and
microscopic
observation.
This
constitutes
a
negative
effect
and
not
`
equivocal'.
7
The
results
of
the
2
year
chronic
oncogenicity
study
in
rats
are
also
in
conflict
with
this
assessment.
The
females
displayed
bladder
carcinoma
only
at
the
high
dose
of
2500
ppm
in
contrast
to
the
males,
which
showed
effects
at
lower
dosages
of
diuron.
The
EPA
document
states
that
focal
hyperplasia
was
observed
in
the
female
only
at
the
mid
(
250
ppm)
and
high
(
2500
ppm)
dose
groups
at
12
and/
or
24
months.
There
were
effects
in
the
females
at
the
250
ppm
dosage,
but
only
at
24
months
and
not
at
12
months.
No
effects
at
the
25
ppm
dosage
in
the
females
were
seen
after
either
12
or
24
months
of
exposure.
These
results
should
cast
some
interpretative
light
on
the
nature
of
the
`
equivocal'
effects
in
the
6
month
study.
HED's
Response:
See
above
HED's
response.
Page
8.
Requirement
870.3100:
90
Day
Oral
Toxicity
Rat,
Para
7,
Line
1.
The
NOEL
cannot
be
determined
because
some
findings
were
judged
to
be
equivocal.
A
NOEL
is
not
defined
by
this
study.
No
effects
were
biologically
relevant
including
the
reticulocyte
count.
The
study
authors
give
10
ppm
as
the
NOEL
without
an
evaluation
of
the
historical
blood
values.
HED's
Response:
See
above
HED's
response.
Page
9.
Requirement
870.3100:
90
Day
Oral
Toxicity
Rat,
General
Registrant
Comment:
A
study
has
been
omitted
from
this
discussion.
It
is
the
"
Study
for
Toxicity
to
Wistar
Rats
with
Special
Attention
to
Urothelial
Alterations
(
Administration
in
Diet
for
2,4,12,
and
26
Weeks
with
Recovery)."
(
Reviewed
in
response
to
MRID
45494501).
Its
significance
is
that
it
allows
the
bladder
effects
that
EPA
judged
to
be
`
equivocal'
to
be
placed
into
perspective.
In
this
study,
male
Wistar
rats
were
administered
diuron
in
their
diet
at
a
concentration
of
2500
ppm
for
2,
4,
12,
or
26
weeks.
Further
animals
were
similarly
treated
for
4
or
26
weeks,
and
then
observed
for
4
or
8
weeks
(
recovery).
One
control
group
(
each
of
10
animals)
was
used
per
treatment
group
(
each
of
10
animals).
Histopathological
examination
of
the
urinary
bladders
revealed
a
treatment
related
increased
incidence
of
hyperplasia
of
the
epithelium,
and
an
increase
in
the
degree
of
hyperplasia
from
treatment
duration
of
four
weeks
onwards.
Hyperplasia
with
exo
and
endophytic
growth
(
within
4
weeks)
and
marked
squamous
epithelial
metaplasia
(
after
26
weeks)
were
found.
Morphometric
measurements
detected
in
addition
an
increase
in
the
sub
epithelial
urinary
bladder
tissue
(
already
apparent
after
treatment
fro
two
weeks).
Examination
of
the
animals
in
the
recovery
groups
revealed
a
clear
trend
towards
reversibility
of
the
induced
alterations
after
cessation
of
treatment.
Bladder
thickening
is
measured
and
given
in
Table
3
below.
The
highest
value
of
492
seen
in
the
blood
study
documented
above
is
well
within
the
normal
values
as
shown
in
this
study
(
noting
differences
between
sexes).
Thickening
of
the
bladder
is
readily
observed
and
exceeds
the
error
as
expressed
by
the
standard
deviations.
This
is
quite
different
than
the
rather
small
changes
seen
in
the
blood
effect
study
above
for
which
no
dose
effect
exceeded
the
standard
deviations.
Table
3.
Areas
of
equally
long
wall
regions
from
paramedian
sections
of
the
urinary
bladder
8
(
relative
units,
mean
and
standard
deviation,
also
number
of
animals
examined
per
group).
Study
Length
Control
Groups
2500
ppm
Diuron
Weeks
Mean
Std
Dev
n
Mean
Std
Dev
n
2
418
45
10
510
110
10
4
439
94
9
635
123
9
8*
521
84
9
565
89
9
12
590
92
10
847
99
9
26
307
110
10
778
115
7
34**
580
90
8
716
84
4
*
4
weeks
diuron,
4
weeks
recovery
**
26
weeks
diuron,
8
weeks
recovery
This
study
is
important
in
that
it
demonstrates
a
marked
trend
towards
reversibility
and
should
be
included
with
the
similar
study
that
focuses
on
the
blood
effects.
HED
Response:
This
study
was
submitted
as
part
of
the
document
entitled
"
Cancer
Classification
and
Mechanism
of
Action
of
Diuron
(
MRID
45494501)"
for
a
proposed
mode
of
action
on
bladder
carcinogenicity.
The
HED's
Mechanism
of
Toxicity
Assessment
Committee
(
MTAC)
reviewed
the
study
and
concluded
that
this
study
suggested
a
reversibility
of
possible
precancerosis
but
did
not
present
or
propose
a
mode
of
action
for
assessment
of
mode
of
action
on
bladder
carcinogenicity
on
diuron.
No
change
necessary.
Page
9.
Requirement
870.3465:
90
Day
Inhalation
Rat
The
HIARC
determined
that
a
28
day
inhalation
study
is
required
to
address
the
concern
for
inhalation
exposure
potential
based
on
use
pattern.
Registrant
Comment:
There
is
no
need
for
a
28
day
inhalation
study
based
either
on
the
use
pattern
or
the
inhalation
toxicity.
See
discussion
relating
to
this
issue
above.
HED
Response:
This
is
a
policy
issue
and
will
be
addressed
in
the
phase
4
period.
Page
9.
Requirement
870.3200:
21
Day
Dermal
Rabbit,
Para
1,
Line
4.
Body
weight,
good
consumption,
clinical
signs .
Registrant
Comment:
Typographical
error:
`
Good'
consumption
should
be
`
food'.
HED
Response:
Changed
to
"
food".
Page
10.
Requirement
870.3700a:
Prenatal
Developmental
Toxicity
Study
Rat,
Para
3.
General
Registrant
Comment:
Paragraph
3
general
comment
on
omission.
Weight
of
both
males
and
females
rebounded
to
nearly
normal
in
all
dose
groups
after
removal
of
diuron
treatment.
This
should
be
noted.
9
HED
Response:
This
observation
confirmed
a
finding
that
the
body
weight
decrease
is
treatmentrelated
No
change
is
necessary.
Page
11.
Requirement
870.3700a:
Prenatal
Developmental
Toxicity
Study
Rat,
Para
2,
Line
2.
Skeletal
malformations/
variations
was
288
(
22),
305(
23),
Registrant
Comment:
Typographical
error:
`
305'
should
be
`
306'.
HED
Response:
Changed
to
"
306".
Page
13.
Requirement
870.3800:
Reproduction
and
Fertility
Effects
Rat,
Para
1,
Line
2.
Test
substance
intake
for
the
treated .
Registrant
Comment:
Test
substance
intake
should
read
`
Overall
test
substance
intake'.
The
dosing
reflects
the
entire
dosing
period.
HED
Response:
The
intakes
of
test
substance
are
estimated
for
F0
and
F1
parental
animals
respectively
by
the
reviewer.
No
change
is
necessary.
Page
13.
Requirement
870.3800:
Reproduction
and
Fertility
Effects
Rat,
Para
3,
Line
8.
Significant
reductions
in
food
consumption
were
observed .
Registrant
Comment:
This
is
in
error.
There
was
not
a
significant
difference
in
the
7
14
day
interval
for
the
females.
HED
Response:
The
sentence
stated
that
"
.....
occasional
significant
differences
from
control
....
were
considered
incidental
to
treatment."
No
change
is
necessary.
Page
14.
Requirement
870.4300:
Combined
Chronic
Toxicity/
Carcinogenicity
Rat,
Para
1,
Line
5.
..
dietary
concentrations
of
0,
1.7,
17,
or
202
mg/
kg/
day
Registrant
Comment:
Typographical
error:
Should
read
`
203
mg/
kg/
day'
HED
Response:
Changed
to
"
203."
Page
14.
Requirement
870.4300:
Combined
Chronic
Toxicity/
Carcinogenicity
Rat,
Para
2,
Line
2.
The
only
treatment
related
clinical
sign
was
reddish
discolored
or
bloody
urine
in
high
dose
males.
Registrant
Comment:
This
implies
that
all
high
dose
males
demonstrated
this
adverse
effect.
The
sentence
should
read,
"
some
high
dose
males".
HED
Response:
Changed
to
"
some
high
dose
males".
Page
15.
Requirement
870.4300:
Combined
Chronic
Toxicity/
Carcinogenicity
Rat,
Para
2,
Line
2.
10
The
hematopoietic
system
and
urinary
bladder
(
and
renal
pelvis)
were
the
primary
diuron
target
organs.
Erythrocyte
damage
resulted
in
hemolytic
anemia
and
compensatory
hematopoiesis
which
were
manifested
as
significantly
decreased...
.
Registrant's
Comment:
The
effects
first
outlined
are
for
the
24
month
interval.
This
needs
to
be
noted.
Also,
in
line
5
of
the
same
sentence
the
parenthetical
phrase
that
states
(<
25%
change
for
most
parameters;
3
fold
increase
for
reticulocytes)
applies
only
to
the
high
dose
males
and
females.
The
mid
dose
animals
do
not
show
this
degree
of
change.
The
low
dose
females
show
a
very
small
increase
of
33%
in
the
erythrocyte
count
and
no
real
change
in
the
other
parameters.
(
Historical
control
data
from
the
conducting
laboratory
during
a
similar
time
period,
show
that
control
animals
can
have
the
same
33%
increase.
See
attached
historical
data.)
For
accuracy,
the
second
sentence
should
read,
"
Erythrocyte
damage
resulted
in
.
in
mid
and
/
or
high
dose
males
and
females,
and
in
low
dose
females.
In
the
high
dose
groups
there
was
<
25%
change
for
most
parameters
with
a
3
fold
increase
for
reticulocytes.
For
the
low
dose
females,
only
an
increase
of
33%
was
observed
in
erythrocyte
count
and
no
real
change
in
the
other
parameters."
HED's
Response:
The
DER
indicated
that
significant
hematological
effects
were
observed
in
the
mid
and
high
dose
males
and
females
as
early
as
6
months.
No
change
is
necessary.
Page
15.
Requirement
870.4300:
Combined
Chronic
Toxicity/
Carcinogenicity
Rat,
Para
3,
Line
2.
Microscopic
evaluation
showed
that
epithelial
focal
hyperplasia
of
the
urinary
tract
and
renal
pelvis
increased
in
severity
in
both
sexes
at
12
and/
or
24
months,
and
increased
in
incidence
(
p<
0.05)
or
0.01)
in
high
dose
males
at
12
months
and
in
mid
and
high
dose
females
at
12
and/
or
24
months.
Registrant's
Comment:
The
mid
dose
females
showed
an
increased
incidence
only
at
24
months.
The
sentence
should
read:
`
Microscopic
evaluation
showed
that
epithelial
focal
hyperplasia
of
the
urinary
tract
and
renal
pelvis
increased
in
severity
in
both
sexes
at
12
and/
or
24
months,
and
increased
in
incidence
(
p<
0.01)
in
high
dose
males
at
12
months
and
in
high
dose
females
at
12
and/
or
24
months
with
mid
dose
females
showing
an
increased
incidence
at
24
months.'
HED's
Response:
Changed
as
Registrant's
comment.
Page
17.
4.6
Carcinogenicity:
Para
3.
There
is
no
additional
information
to
justify
a
re
classification
of
the
cancer
classification
for
diuron
at
this
time.
Registrant's
comment:
The
change
in
classification
of
mutagenic
to
non
mutagenic
is
enough
information
to
re
classify
the
chemical
from
known/
likely
to
likely.
It
should
be
enough
to
just
indicate
that
diuron
will
not
be
re
classified
until
the
new
guidelines
are
finalized.
HED'
Response:
The
sentence
is
revised
to
"
Diuron
will
not
be
re
classified
at
this
time."
Page
19.
Requirement
870.4200b:
Carcinogenicity
(
feeding)
Mouse,
Para
3,
Line
1.
and
ovarian
luteomas
(
control,
6%;
2500
ppm,
14%)
in
female .
11
Registrant,'
Comment:
The
reference
to
luteomas
should
be
deleted.
The
CPRC
made
the
decision
(
May
8,
1997)
that
the
effect
was
inconsequential.
Combined
sex
cord
stromal
tumors
are
a
better
reflection
of
the
system
than
`
luteomas'.
There
is
no
statistical
difference
between
control
and
treated
groups
for
ovarian
combined
sex
cord
stromal
tumors.
HED'
Response:
Additional
wording
is
added
to
the
document
to
address
this
issue.
"
On
December
18,
1996
the
Carcinogenicity
Peer
review
Committee
(
CPRC)
determined
that
the
female
mouse
ovarian
tumor
rates
table
should
reflect
the
more
appropriate
'
combined
sex
cord
stromal
tumors'
nomenclature
in
lieu
of
the
"
luteoma"
terminology
used
in
the
qualitative
risk
assessment
(
Lori
L.
Brunsman
to
Linda
L.
Taylor,
11/
20/
96).
Dr.
Lucas
Brennecke,
EPA's
consulting
pathologist,
confirmed
that
the
combined
tumor
counts
are
more
appropriate
than
the
individual
counts
for
ovarian
tumors,
as
it
is
difficult
to
distinguish
between
the
different
types
of
ovarian
tumors.
The
CPRC
concluded
that
female
mice
do
not
have
a
significant
increasing
trend,
or
any
significant
differences
in
the
pair
wise
comparisons
of
the
dosed
groups
with
the
controls,
for
ovarian
combined
sex
cord
stromal
tumors."
Page
19.
4.7
Mutagenicity:
Para
1,
Line
5.
Sprague
Dawley
rats
in
one
study
and
statistically
significant
increases
in
cells
with
structural
aberrations
in
a
second
study
conducted
with
the
same
rat
strain.
The
data
from
the
latter
study,
however,
were
shown
to
fall
within
the
historical
control
range.
There
is
only
one
study
for
the
rat
bone
marrow
chromosomal
aberration
assay.
It
is
HLR
366
85.
It
was
assigned
the
MRID
00146611.
This
study
was
revised
in
1995
to
include
the
historical
aberration
frequencies
that
changed
the
assessment
of
the
results.
The
revised
report
bears
the
same
laboratory
designation
HLR
366
85
but
was
assigned
a
new
MRID
of
44350301.
All
references
to
the
first
study
designated
by
MRID
00146611
can
be
deleted.
The
reference
to
a
second
study
showing
statistically
significant
increases
in
structural
aberrations
was
only
at
the
48
hour
post
treatment
interval.
Nothing
was
observed
at
either
6
or
24
hours.
Suggested
wording:
"
There
were
marginal
statistically
significant
increases
in
cells
with
structural
aberrations
in
a
Sprague
Dawley
rat
in
vivo
bone
marrow
chromosomal
aberration
assay.
However,
the
levels
of
aberrations
were
within
the
historical
control
range
and
assessed
negative."
Note
the
type
in
the
word
evidence
in
the
last
sentence
of
the
paragraph.
Typographical
error:
The
word
`
does'
should
be
changed
to
`
dose.'
HED's
Response:
(
1)
Changed
to
"
dose".
(
2)
Deleted
the
study
(
MRID
00146611)
and
revised
wording
as
comment.
Page
20.
Requirement
870.5385:
Cytogenetics
Middle
Row
in
Table.
Registrant's
Comment:
Guideline
870.5385
..
MRID
#
00146611.
This
study
is
identical
to
the
one
above
and
should
be
deleted.
HED's
Response:
Deleted
the
study
(
MRID
00146611)
from
the
table.
Page
22.
5.3.1
Conclusions:
Line
1
Treatment
of
diuron
resulted
in
a
significant
increase
in
the
incidences
of
urinary
bladder
carcinoma
in
both
sexes
of
the
Wistar
rat,
kidney
carcinomas
in
the
male
rat
(
a
rare
tumor)
and
mammary
gland
carcinomas
in
the
female
NMRI
mouse.
Registrant's
Comment:
The
way
this
sentence
is
phrased,
it
implies
that
the
incidences
of
kidney
carcinomas
were
also
significant.
There
was
no
statistical
significance
attached
to
the
incidences
of
renal
pelvis
tumors.
Reference
should
either
be
deleted
or
the
lack
of
statistical
significance
for
this
tumor
should
be
referenced.
12
HED's
Response:
This
is
the
conclusion
of
the
HED's
Carcinogenicity
Peer
Review
Committee
(
HED
Doc.
No.
012224).
No
change
is
necessary.
Page
28.
9.1.2
Subchronic,
Chronic
and
Other
Toxicity
Tables:
870.3100
Results
The
NOEL
cannot
be
determined
based
on
equivocal
findings
in
the
urinary
bladder
including
blood
vessel
dilation,
reduced
transparency,
and
increased
firmness.
Registrant's
Comment:
A
NOEL
can
be
established.
In
the
discussion
of
this
study
above,
there
was
more
than
adequate
evidence
that
the
gross
observations
did
not
match
either
the
histopathology
or
the
measurement
of
bladder
thickness.
The
pathologist
dismissed
the
gross
findings
as
not
relevant
to
the
assessment.
The
NOEL
should
be
set
based
on
the
blood
effects.
The
doses
should
read
"
0,
0.3,
0.8,
1.8",
not
"
0,
0,
0.3,
0.8,
1.8."
HED's
Response:
(
1)
See
above
HED's
response
on
the
NOAEL
issue.
(
2)
Corrected
the
doses
as
comment.
Page
29.
9.1.2
Subchronic,
Chronic
and
Other
Toxicity
Tables:
870.5100
Results
TA100
up
to
the
highest
does
tested
Registrant's
Comment:
Typographical
error:
The
word
`
does'
should
be
changed
to
`
dose.'
HED's
Response:
Changed
to
"
dose".
Page
30.
9.1.2
Subchronic,
Chronic
and
Other
Toxicity
Tables:
870.5375
Results
Registrant's
Comment:
The
description
of
results
is
quite
long
and
inconsistent
with
the
brevity
of
the
rest
of
the
Table.
Would
suggest
deleting
much
of
the
material
and
matching
it
in
content
with
the
other
mutagenicity
experiments.
HED's
Response:
Revised
as
comment.
Page
31.
9.1.2
Subchronic,
Chronic
and
Other
Toxicity
Tables:
870.5375
Results
Registrant's
Comment:
This
first
item
on
page
31
of
the
Table
can
be
deleted.
The
study
was
revised
and
the
results
are
reflected
in
MRID#
44350301
on
the
last
page.
HED
Response:
Deleted
the
study
(
MRID
00146611).
II.
HED
Chapter
Page
1.
First
Para,
Line
15.
Application
rates
range
from
0.8
lbs
active
ingredient
(
ai)/
acre
for
corn
to
87.1
lbs
ai/
acre
for
non
crop
areas.
Registrant's
Comment:
The
rate
of
87.1
lbs
ai/
acre
is
exaggerated.
We
can
find
no
label
to
back
these
claims.
HED's
Response:
Registration
769
638
includes
a
label
rate
of
10
lbs
per
1000
ft2.
The
label
is
for
Granular
Dy
Kil
20
and
is
intended
for
use
in
irrigation
and
drainage
ditches.
It
is
manufactured
by
Southern
Mill
Creek
Product
Company.
Using
a
standard
conversion
of
43,560
ft2
per
acre
and
including
a
20%
a.
i.
concentration
from
the
end
use
label
the
resulting
application
rate
is
87.12
lbs
13
a.
i.
per
acre.
No
change
necessary.
Page
29.
Last
Para,
Line
7.
Registrant's
Comment:
The
word
"
mile"
should
be
"
mile2".
Also,
this
use
rate
(>
1379
lb
ai/
mile2/
yr)
is
not
possible,
both
in
this
document
and
in
the
Drinking
Water
Assessment
from
which
it
is
quoted.
This
rate
is
equivalent
to
2.15
lb
ai/
acre,
a
rate
that
is
obtainable
as
an
average
only
if
every
acre
in
the
area
was
planted
to
cotton
and
100%
of
those
acres
received
the
maximum
annual
diuron
rate
for
clay
soils,
a
treatment
program
that
would
also
require
all
the
acres
to
receive
2
treatments
each
year.
In
the
subject
area,
soils
are
primarily
sandy
loam,
the
percentage
of
the
crop
treated
averages
about
50%
and
only
about
30%
of
the
acres
received
two
treatments.
These
parameters
would
produce
a
maximum
use
rate
of
1.2
lb
ai/
treated
acre/
yr
or
827.4
lb
ai/
mile
2/
yr
for
the
whole
area
if
it
were
100%
planted
to
cotton
and
50%
was
treated.
HED's
Response:
The
Environmental
Fate
and
Effects
Division
will
respond
to
this
comment
under
separate
cover
memo.
III.
Chronic
Dietary
Exposure
Assessment
Page
2.
Table,
Last
row,
2nd
column.
Registrant's
Comment:
The
Q1
*
should
be
"
1.91",
not
"
1.191."
HED's
Response:
This
typographical
error
is
noted.
It
is
also
noted
that
the
correct
value
was
included
in
the
dietary
exposure
and
risk
assessment,
1.91.
IV.
Drinking
Water
Assessment
Registrant's
Comment:
The
Agency
used
the
PRZM/
EXAMS
model
that
has
never
been
adequately
validated.
Nevertheless,
the
model
can
produce
results
that
predict
residue
levels
in
surface
water
reasonably
well
if
used
properly.
The
results
produced
by
this
model
are
very
sensitive
to
the
input
parameters
that
drive
the
computations.
When
inappropriate
input
parameters
are
selected,
as
is
the
case
in
this
assessment,
the
model
grossly
overestimates
residues
moving
into
surface
water.
Consequently,
the
results
from
the
model
are
incorrect
and
misrepresents
the
diuron
residues
likely
to
occur
in
drinking
water.
Some
of
the
incorrect
input
parameters
are
discussed
below.
A
more
thorough
assessment,
including
results
of
the
PRZM/
EXAMS
model
using
the
appropriate
input
parameters,
will
be
filed
during
the
public
comment
period.
Some
examples
of
inappropriate
input
parameters
EPA
used
in
the
model
are:
1.
The
Agency
chose
to
model
drinking
reservoirs
in
Osceola
County,
FL,
an
area
in
which
there
are
no
large
drinking
reservoirs.
2.
The
wrong
soil
type
was
used
for
the
area
being
modeled.
The
soil
in
the
Osceola
County,
FL,
area
is
loamy
sand
which
has
a
good
recharge
capacity.
In
their
use
of
the
model,
the
Agency
used
high
clay
soil
which
has
high
runoff
rates
and
little
recharge
capacity.
3.
The
Agency
assumed
that
all
of
the
chemical
was
deposited
on
the
top
of
the
soil.
Diuron
has
measurable,
but
limited
mobility
in
soil.
Changes
to
the
model
that
assume
the
chemical
applied
resides
in
the
top
4
cm
produce
runoff
estimates
10
to
40
fold
lower
than
the
levels
produced
when
the
chemical
is
assumed
to
reside
on
the
surface.
The
Agency
has
acknowledged
that
the
results
obtained
from
the
PRZM/
EXAMS
model
are
from
9
to
100
times
higher
than
the
data
obtained
from
the
various
monitoring
programs,
including
the
14
monitoring
data
from
the
US
Geological
Survey
(
USGS)
National
Water
Quality
Assessment
Program
(
NAWQA)
.
It
appears
that
the
large
difference
between
the
modeling
results
and
the
results
of
the
USGS
program
have
contributed
to
the
Agency's
concern
as
to
whether
the
USGS
data
are
reasonably
representative
of
residue
levels
of
diuron
in
surface
waters.
EPA
has
expressed
this
concern
in
spite
of
the
fact
that
the
USGS
results
come
from
over
1400
samples
from
62
streams
over
a
7
year
period.
Griffin
fully
expects
that
when
appropriate
input
parameters
are
used,
the
PRZM/
EXAMS
model
will
produce
results
that
will
give
the
Agency
more
confidence
in
the
monitoring
data
from
the
US
Geological
Survey
(
USGS)
National
Water
Quality
Assessment
Program
(
NAWQA).
The
Agency
has
included
in
its
Drinking
Water
Assessment
the
results
of
a
monitoring
study
performed
in
the
playa
lakes
of
the
high
plains
of
western
Texas.
In
characterizing
the
results
of
this
study,
the
Agency
failed
to
recognize
that
the
playa
lakes
are
temporary
bodies
of
water
with
no
natural
outlets.
Water
from
these
"
lakes"
either
evaporates
or
infiltrates
into
the
soil.
The
area
that
becomes
a
playa
lake
may
be
planted
to
cotton
or
another
crop
in
a
previous
year
or
even
early
in
the
same
year
in
which
runoff
due
to
large
rainfall
events
create
the
playa
lake.
Consequently,
pesticide
residues
in
these
temporary
water
bodies
may
result,
not
only
from
surface
water
runoff
from
adjacent
fields
but
from
direct
application
to
the
area
of
the
lake
before
flooding
occurred.
Water
bodies
such
as
the
playa
lakes
are
never
used
as
sources
of
drinking
water.
Residue
levels
from
such
water
bodies,
while
of
academic
interest,
have
no
bearing
on
the
levels
of
pesticides
in
drinking
water.
In
their
lack
of
an
outlet
and
their
water
source
being
runoff
from
a
rather
large
area
of
heavily
cropped
land,
the
playa
lakes
bear
some
similarity
to
the
Index
Reservoir
scenario
EPA
utilized
in
its
use
of
the
PRZM/
EXAMS
model.
The
huge
differences
between
the
results
of
the
model
and
the
playa
lakes
results
should
have
led
the
Agency
to
re
examine
the
input
parameters
it
used
in
the
model.
In
its
discussion
of
the
playa
lakes
study,
EPA
stated
that
diuron
usage
in
the
area
of
Texas
that
includes
the
playa
lakes
"
reached
and
average
of
>
1379
lb
ai/
mile
2/
yr.".
This
use
rate
is
simply
not
possible.
This
rate
is
equivalent
to
2.15
lb
ai/
acre,
a
rate
that
is
obtainable
as
an
average
only
if
every
acre
in
the
area
was
planted
to
cotton
and
100%
of
those
acres
received
the
maximum
annual
diuron
rate
for
clay
soils,
a
treatment
program
that
would
also
require
all
the
acres
to
receive
2
treatments
each
year.
In
the
subject
area,
soils
are
primarily
sandy
loam,
the
percentage
of
the
crop
treated
averages
about
50%,
and
only
about
30%
of
the
acres
receive
two
treatments.
These
parameters
would
produce
an
maximum
use
rate
of
1.2
lb
ai/
treated
acre/
yr
or
827.4
lb
ai/
mile
2/
yr
for
the
whole
area
if
it
were
100%
planted
to
cotton
and
50%
was
treated.
The
Agency
stated
that
there
is
no
aerobic
and
anaerobic
aquatic
studies
available;
however,
DuPont
has
submitted
both
studies,
MRID
#
s
42260501
and
42661901.
The
Agency
assumed
a
one
year
half
life
in
water
which
is
contradictory
to
page
8,
paragraph
3
of
the
Diuron
Metabolism
Committee
Briefing
Memo
which
agrees
with
our
studies
estimating
a
half
life
of
33
days
in
water
and
1.2
days
in
sediment.
The
Agency
used
a
soil
half
life
of
372
days
and
our
data
show
half
lives
ranging
from
20
to
372
days.
MRID
#
s
41709305,
44654001,
44738001
and
44865001.
The
choice
of
the
most
extreme
half
life
is
just
not
a
conservative
choice
as
the
Agency
claims
but
is
a
worst
case
choice
and
is
not
representative
of
major
diuron
use
areas.
HED's
Response:
The
Environmental
Fate
and
Effects
Division
will
respond
to
this
comment
under
separate
cover
memo.
Page
43.
Registrant's
Comment:
The
references
are
misnumbered,
appear
to
be
incomplete
and
may
be
15
misplaced.
HED's
Response:
No
error
noted.
V.
Report
of
the
HIARC
Page
16.
First
Para,
Line
5.
Registrant's
Comment:
The
value
"
0.8"
should
be
"
0.88."
HED's
Response:
This
typographical
error
is
noted.
However,
no
change
is
necessary
in
the
revised
HED
chapter.
VI.
RED,
Residue
Chemistry
Considerations
Registrant's
Comment:
The
Table
of
Contents
is
not
numbered
correctly.
HED's
Response:
The
error
will
be
corrected
in
the
next
version
of
the
Residue
Chemistry
Chapter.
Registrant's
Comment:
Studies
have
been
submitted
for
the
following
crops:
alfalfa
MRID
#
45508703;
lemons
MRID
#
45509702;
wheat
MRID
#
45509703;
and
alfalfa
MRID
#
45509704.
HED's
Response:
The
study
identified
as
MRID
45508703
is
not
a
submission
from
the
registrant
that
concerns
diuron
or
alfalfa
in
any
matter
related
to
this
assessment.
We
acknowledge
that
lemon
MRID
45509702;
wheat
MRID
45509703;
and
alfalfa
MRID
45509704
were
inadvertently
not
included
in
the
Chemistry
Chapter
and
are
currently
in
the
Agency's
review
process.
HED
notes
the
MRID
numbers
quoted
by
the
registrant
for
wheat
and
alfalfa
are
incorrect.
The
correct
MRID
for
the
wheat
study
is
45509704
and
the
correct
MRID
for
the
alfalfa
study
is
45509703.
Registrant's
Comment:
Portions
of
the
residue
data
used
by
EPA
in
the
memorandum
entitled
Chronic
Dietary
Exposure
Assessment
differs
from
those
data
submitted
and
cited
in
the
Residue
Chemistry
Chapter,
but
apparently
were
not
used.
Below
is
a
summary
of
the
residue
data
in
which
we
differ
from
EPA,
along
with
an
explanation
for
that
difference,
MRID
numbers
and
references.
These
errors
lead
to
a
drastically
overstated
dietary
risk,
particularly
in
those
processed
commodities
where
the
Agency
has
ignored
the
available
data.
The
Agency
has
defaulted
to
their
percent
crop
treated
even
though
accurate
crop
treat
data
were
presented
by
Griffin
LLC.
HED's
Response:
The
residue
data
that
was
used
for
the
input
to
the
chronic
dietary
assessment
was
taken
from
field
trial
data
submitted
by
the
registrant
to
support
tolerances.
As
is
the
case
for
apple,
banana,
berries,
grapefruit,
grapes,
lemons,
limes,
oranges,
pineapples,
and
wheat
processed
commodities,
there
exists
more
than
one
field
trial
study.
If
the
application
rates
and
PHI's
are
appropriate
to
the
current
labeling
and
the
study
adheres
to
current
Agency
guidelines
for
geographic
distribution
and
analytical
methodology,
any
study
could
be
used
to
develop
the
residue
value(
s)
for
the
exposure
computation.
With
the
exception
of
wheat
and
berries,
the
residue
values
are
essentially
non
detectable
and
the
difference
between
the
studies
are
essentially
in
the
limits
of
detection
of
the
method.
The
studies
referred
to
by
the
registrants
will
be
examined
to
determination
if
the
processing
factors
reported
16
therein
are
more
appropriate
than
those
presently
used.
It
is
presently
HED
policy
to
use
the
percent
crop
treated
data
provided
by
BEAD.
Registrant's
Comment:
MRID
#
43434301
Apples
=
0.007
ppm
=
Mean
of
Field
Trial
data
(
All
samples
were
less
than
LOD
(
0.0145
ppm)
so
½
LOD
was
used)
Residue
Factor
of
2.
In
a
processing
study,
all
residues
in
pomace
and
juice
were
less
than
0.013
at
a
3X
treatment
rate.
Food
Name
Anticipated
Residues
from
Residue
Studies
Anticipated
Residues
from
EPA
Adj
#
1
Adj
#
1
EPA
Adj
#
2
Adj
#
2
EPA
Concentration
Factor
%
Crop
Treated
Apples
0.007
0.016
1
1
0.11
0.13
Apples
Dried
0.007
0.016
8
8
0.11
0.13
Apples
Juice
0.007
0.016
1
1.3
0.11
0.13
Apple
Juice
Conc
0.007
0.016
3
3.9
0.11
0.13
HED's
Response:
The
percent
of
crop
treated
are
weighted
averages
provided
by
the
Biological
and
Economic
Analysis
Division
(
BEAD)
in
a
Quantitative
Usage
Analysis
issued
3
20
01
and
supplemented
for
miscellaneous
usage
sites
on
04
27
2001.
Registrant's
Comment:
MRID
#
44583001
Bananas
=
0.005
ppm
=
Mean
of
Field
Trial
data.
All
values
were
less
than
LOQ,
but
were
reported
as
actual
values.
The
two
reported
values
above
LOQ
(
i.
e.
0.005
ppm)
were
used
while
the
values
reported
below
0.005
ppm
were
replaced
with
0.005
ppm.
This
led
to
a
mean
value
of
0.005
ppm.
Food
Name
Anticipated
Residues
from
Residue
Studies
Anticipated
Residues
from
EPA
Adj
#
1
Adj
#
1
EPA
Adj
#
2
Adj
#
2
EPA
Concentration
Factor
%
Crop
Treated
Bananas
0.005
0.025
1
1
0.05
0.14
Bananas
Dried
0.005
0.025
3.9
3.9
0.05
0.14
Bananas
Juice
0.005
0.025
1
1
0.05
0.14
HED's
Response:
The
percent
of
crop
treated
are
weighted
averages
provided
by
the
Biological
and
Economic
Analysis
Division
(
BEAD)
in
a
Quantitative
Usage
Analysis
issued
3
20
01
and
supplemented
for
miscellaneous
usage
sites
on
04
27
2001.
Registrant's
Comment:
MRID
#
44797701
Blackberries
=
0.02
ppm
=
Mean
of
Field
Trial
data.
The
LOQ
was
0.04
ppm
and
all
values
were
reported
as
either
0
or
0.017
ppm.
We
used
½
LOQ
(
i.
e.
0.02
ppm)
for
all
the
samples,
which
gives
an
average
residue
of
0.02
ppm.
MRID
#
44544101
Blueberries
=
0.02
ppm
=
Mean
of
Field
Trial
data.
The
LOQ
was
0.04
ppm
and
all
values
were
reported
as
zero,
therefore
½
LOQ
was
used.
Boysenberries,
Currants,
Dewberries,
Huckleberries
and
Loganberries
=
0.02
ppm
=
Mean
of
field
trial
data.
Value
taken
from
blackberry/
blueberry
study.
Food
Name
Anticipated
Residues
from
Residue
Studies
Anticipated
Residues
from
EPA
Adj
#
1
Adj
#
1
EPA
Adj
#
2
Adj
#
2
EPA
Concentration
Factor
%
Crop
Treated
Blackberries
0.02
0.1
1
1
0.53
0.53
17
Blackberries
Juice
0.02
0.1
1
1
0.53
0.53
Blueberries
0.02
0.1
1
1
0.29
0.29
Boysenberries
0.02
0.1
1
1
0.53
0.07
Currants
0.02
0.1
1
1
0.29
0.31
Dewberries
0.02
0.1
1
1
0.53
0.53
Huckleberries
0.02
0.1
1
1
0.29
0.29
Loganberries
0.02
0.1
1
1
0.53
0.33
HED's
Response:
The
percent
of
crop
treated
are
weighted
averages
provided
by
the
Biological
and
Economic
Analysis
Division
(
BEAD)
in
a
Quantitative
Usage
Analysis
issued
3
20
01
and
supplemented
for
miscellaneous
usage
sites
on
04
27
2001.
Registrant's
Comment:
MRID
#
43339201
Grapefruit
=
0.006
ppm
=
All
Field
Trial
values
are
less
than
LOD
of
0.0110
ppm,
therefore
½
of
the
LOD
was
used.
A
processed
commodity
study
accepted
by
the
Agency
which
demonstrated
no
concentration
in
juice
was
ignored.
Food
Name
Anticipated
Residues
from
Residue
Studies
Anticipated
Residues
from
EPA
Adj
#
1
Adj
#
1
EPA
Adj
#
2
Adj
#
2
EPA
Concentration
Factor
%
Crop
Treated
Grapefruit
Juice
0.006
0.012
1
2.1
0.36
0.47
Grapefruit
Juice
Concentrate
0.006
0.012
1
8.26
0.36
0.47
Grapefruit
Peeled
Fruit
0.006
0.012
1
1
0.36
0.47
HED's
Response:
The
percent
of
crop
treated
are
weighted
averages
provided
by
the
Biological
and
Economic
Analysis
Division
(
BEAD)
in
a
Quantitative
Usage
Analysis
issued
3
20
01
and
supplemented
for
miscellaneous
usage
sites
on
04
27
2001.
Registrant's
Comment:
MRID
#
43421501
Grapes
=
0.008
ppm.
All
Field
Trial
values
are
less
than
the
LOD
of
0.0160
ppm,
therefore
½
LOD
was
used.
A
processing
study
which
demonstrates
no
concentration
in
raisins
has
been
ignored.
Food
Name
Anticipated
Residues
from
Residue
Studies
Anticipated
Residues
from
EPA
Adj
#
1
Adj
#
1
EPA
Adj
#
2
Adj
#
2
EPA
Concentration
Factor
%
Crop
Treated
Grapes
0.008
0.021
1
1
0.1
0.1
Grapes
Juice
0.008
0.021
1
1.2
0.1
0.1
Grapes
Juice
Concentrate
0.008
0.021
1
3.6
0.1
0.1
Grapes
Leaves
0.008
0.021
1
1
0.1
0.1
Grapes
Raisins
0.008
0.021
1
4.3
0.1
0.1
Grapes
Wine
0.008
0.021
1
1
0.1
0.1
HED's
Response:
The
percent
of
crop
treated
are
weighted
averages
provided
by
the
18
Biological
and
Economic
Analysis
Division
(
BEAD)
in
a
Quantitative
Usage
Analysis
issued
3
20
01
and
supplemented
for
miscellaneous
usage
sites
on
04
27
2001.
Registrant's
Comment:
MRID
#
45509702
Lemons
=
0.09
ppm
=
Mean
of
Field
Trial
data.
Four
of
6
samples
were
less
than
LOQ,
so
½
LOQ
(
i.
e.
0.005
ppm)
was
used
for
those
samples.
The
other
two
samples
were
at
0.2
ppm
and
0.32
ppm.
When
taken
all
together,
this
gives
a
mean
of
0.09
ppm.
Food
Name
Anticipated
Residues
from
Residue
Studies
Anticipated
Residues
from
EPA
Adj
#
1
Adj
#
1
EPA
Adj
#
2
Adj
#
2
EPA
Concentration
Factor
%
Crop
Treated
Lemons
Juice
0.09
0.05
2
2
0.2
0.26
Lemons
Juice
Concentrate
0.09
0.05
11.4
11.4
0.2
0.26
Lemons
Peeled
Fruit
0.09
0.05
1
1
0.2
0.26
HED's
Response:
The
percent
of
crop
treated
are
weighted
averages
provided
by
the
Biological
and
Economic
Analysis
Division
(
BEAD)
in
a
Quantitative
Usage
Analysis
issued
3
20
01
and
supplemented
for
miscellaneous
usage
sites
on
04
27
2001.
Registrant's
Comment:
MRID
#
45509702
Limes
=
0.09
ppm
=
Lemon
Field
Trial
data
used
for
lime.
A
processed
commodity
study
accepted
by
the
Agency
which
demonstrated
no
concentration
in
juice
was
ignored.
Food
Name
Anticipated
Residues
from
Residue
Studies
Anticipated
Residues
from
EPA
Adj
#
1
Adj
#
1
EPA
Adj
#
2
Adj
#
2
EPA
Concentration
Factor
%
Crop
Treated
Limes
Juice
0.09
0.05
1
2
0.2
0.33
Limes
Juice
Concentrate
0.09
0.05
1
6
0.2
0.33
Limes
Peel
0.09
0.05
1
1
0.2
0.33
Limes
Peeled
Fruit
0.09
0.05
1
1
0.2
0.33
HED's
Response:
The
percent
of
crop
treated
are
weighted
averages
provided
by
the
Biological
and
Economic
Analysis
Division
(
BEAD)
in
a
Quantitative
Usage
Analysis
issued
3
20
01
and
supplemented
for
miscellaneous
usage
sites
on
04
27
2001.
Registrant's
Comment:
MRID
#
43339201
Oranges
=
0.007
ppm
=
Mean
orange
Field
Trial
residue
was
used.
Orange
juice
processing
factor
of
0.96
was
calculated
from
MRID
#
43260101.
To
get
orange
juice
concentrate,
the
ratio
of
the
orange
juice
concentrate
and
orange
juice
default
processing
factors
(
6.7/
1.8)
were
multiplied
by
0.96,
which
equals
3.6.
The
default
processing
factors
was
used
by
EPA.
A
processed
commodity
study
accepted
by
the
Agency
which
demonstrated
no
concentration
in
juice
was
ignored.
Food
Name
Anticipated
Residues
from
Residue
Studies
Anticipated
Residues
from
EPA
Adj
#
1
Adj
#
1
EPA
Adj
#
2
Adj
#
2
EPA
Concentration
Factor
%
Crop
Treated
19
Oranges
Juice
0.007
0.03
0.96
1.8
0.46
0.51
Oranges
Juice
Concentrate
0.007
0.03
1
6.7
0.46
0.51
Oranges
Peel
0.007
0.03
1
1
0.46
0.51
Oranges
Peeled
Fruit
0.007
0.03
1
1
0.46
0.51
HED's
Response:
The
percent
of
crop
treated
are
weighted
averages
provided
by
the
Biological
and
Economic
Analysis
Division
(
BEAD)
in
a
Quantitative
Usage
Analysis
issued
3
20
01
and
supplemented
for
miscellaneous
usage
sites
on
04
27
2001.
Registrant's
Comment:
MRID
#
42798501
Pineapples
=
0.004
ppm
=
Average
residue
data
from
RAC
portion
of
Processing
study.
These
were
used
because
they
were
from
a
4
5X
application
rate.
0.25
is
juice
processing
factor
from
processing
study.
0.93
=
0.25
x
the
ratio
of
the
juice
concentrate
to
juice
default
processing
factors
(
6.3/
1.7),
which
=
0.93.
Five
is
the
default
processing
factor
for
dried
pineapples.
Food
Name
Anticipated
Residues
from
Residue
Studies
Anticipated
Residues
from
EPA
Adj
#
1
Adj
#
1
EPA
Adj
#
2
Adj
#
2
EPA
Concentration
Factor
%
Crop
Treated
Pineapples
dried
0.04
0.1
5
5
0.8
0.13
Pineapples
juice
0.04
0.07
0.25
1.7
0.8
0.13
Pineapples
juice
Concentrate
0.04
0.07
0.93
6.3
0.8
0.13
Pineapples
peeled
fruit
0.04
0.1
1
1
0.8
0.13
HED's
Response:
The
percent
of
crop
treated
are
weighted
averages
provided
by
the
Biological
and
Economic
Analysis
Division
(
BEAD)
in
a
Quantitative
Usage
Analysis
issued
3
20
01
and
supplemented
for
miscellaneous
usage
sites
on
04
27
2001.
Registrant's
Comment:
MRID
#
42740401
Wheat
=
0.025
ppm
=
Mean
Field
Trial
residue
(
All
residues
less
than
LOQ
of
0.05
ppm,
so
0.025
ppm
was
used).
Wheat
bran
and
wheat
flour
processing
factors
calculated
from
wheat
processing
study.
Food
Name
Anticipated
Residues
from
Residue
Studies
Anticipated
Residues
from
EPA
Adj
#
1
Adj
#
1
EPA
Adj
#
2
Adj
#
2
EPA
Concentration
Factor
%
Crop
Treated
Wheat
Bran
0.025
0.3
2
1
0.01
0.01
Wheat
Flour
0.025
0.019
0.33
1
0.01
0.01
Wheat
Germ
0.025
0.3
1
1
0.01
0.01
Wheat
Germ
Oil
0.025
0.3
1
1
0.01
0.01
Wheat
Rough
0.025
0.136
1
1
0.01
0.01
HED's
Response:
The
percent
of
crop
treated
are
weighted
averages
provided
by
the
20
Biological
and
Economic
Analysis
Division
(
BEAD)
in
a
Quantitative
Usage
Analysis
issued
3
20
01
and
supplemented
for
miscellaneous
usage
sites
on
04
27
2001.
In
addition
to
this
review
of
the
Human
Health
Risk
Assessment
for
diuron,
several
discrepancies
were
noted
in
the
previous
review
of
the
RED
for
diuron.
These
comments
are
reiterated
below:
Diuron:
2nd
Report
of
the
Hazard
Identification
Assessment
Review
Committee
1.1
Acute
Reference
Dose
(
RfD)
No
errors
noted.
1.2
Chronic
Reference
Dose
(
RfD)
Registrant's
Comment:
Paragraph
1,
Line
5,
of
Executive
Summary.
The
high
dose
female
group,
according
to
the
text
of
the
study
report,
is
listed
as
"
203
mg/
kg/
day"
rather
than
"
202
mg/
kg/
day."
Paragraph
2,
Lines
1
2,
of
Executive
Summary.
The
sentence,
"
The
only
reported
related
clinical
sign
was
reddish
discolored
or
bloody
urine
in
high
dose
males."
This
implies
all
high
dose
males
showed
this
effect
which
was
not
the
case.
This
sentence
should
read,
"
in
some
high
dose
males."
Paragraph
3,
Line
1,
of
Executive
Summary.
The
first
sentence
should
be
prefaced
with,
"
At
24
months,"
to
be
correct.
Also
in
line
5
of
the
same
sentence,
the
parenthetical
phrase
that
states
(<
25%
change
for
most
parameters;
3
fold
increase
for
reticulocytes)
applies
only
to
the
high
dose
males
and
females.
The
mid
dose
animals
do
not
show
this
degree
of
change.
The
low
dose
females
show
a
very
small
increase
of
33%
in
the
erythrocyte
count
and
no
real
change
in
the
other
parameters.
For
accuracy,
the
first
sentence
of
the
second
paragraph
should
read:
At
24
months,
diuron
affected
hematopoietic
system
resulting
in
hemolytic
anemia
and
compensatory
hematopoiesis,
which
were
manifested
as
significantly
decreased
(
P<
0.05
or
0.01)
erythrocyte
counts,
hemoglobin
levels,
and
hematocrit
and
increased
MCV,
MCH,
abnormal
erythrocyte
forms,
reticulocyte
counts,
and
leukocyte
counts
(
with
no
effects
on
differential
counts)
in
mid
and/
or
high
dose
males
and
females,
and
in
low
dose
females.
In
the
high
dose
groups
there
was
<
25%
change
for
most
parameters
with
a
3
fold
increase
for
reticulocytes.
For
the
low
dose
females
only
an
increase
of
33%
was
observed
in
erythrocyte
count
and
no
real
change
in
the
other
parameters.
Paragraph
4,
Second
Sentence,
of
the
Executive
Summary
states,
"
Microscopic
evaluation
showed
that
epithelial
focal
hyperplasia
of
the
urinary
tract
and
renal
pelvis
increased
in
severity
in
both
sexes
at
12
and/
or
24
months,
and
increased
in
incidence
(
p<
0.01)
in
high
dose
males
at
12
months
and
in
mid
and
high
dose
females
at
12
and/
or
24
months."
The
mid
dose
females
showed
an
increased
incidence
only
at
24
months.
The
sentence
should
read:
Microscopic
evaluation
showed
that
epithelial
focal
hyperplasia
of
the
urinary
tract
and
renal
pelvis
increased
in
severity
in
both
sexes
at
12
and/
or
24
months,
and
increased
in
incidence
(
p<
0.01)
in
high
dose
males
at
12
months
and
in
high
dose
females
at
12
and/
or
24
months
with
mid
dose
females
showing
an
increased
incidence
at
24
months.
HED's
Response:
See
above
HED's
response
in
the
toxicology
chapter
section.
Dose
and
Endpoint
for
Establishing
RfD
Registrant's
Comment:
This
analysis
provides
a
1.0
mg/
kg/
day
LOAEL
and
no
NOAEL.
The
dose
of
1.0
mg/
kg/
day
represents
a
LOEL
and
not
a
LOAEL
because
of
the
compensatory
response
to
the
minor
changes
seen
in
the
females
at
the
low
dose
(
only
33%
increase
in
erythrocytes).
In
fact,
a
NOAEL
could
be
established
as
distinct
from
a
NOEL
or
LOEL.
Because
the
anemia
is
compensated
21
by
an
increase
in
erythrocytes,
the
end
effect
is
not
adverse.
We
would
suggest
that
the
Agency
consider
the
LOAEL
as
a
NOAEL.
HED's
Response:
The
LOAEL
was
established
based
on
evidence
of
hemolytic
anemia
and
compensatory
hematopoiesis.
No
change
is
necessary.
1.3
Occupational/
Residential
Exposure
1.3.1
Registrant's
Comment:
Paragraph
3,
Line
3,
of
the
Executive
Summary
states
the
absolute
body
weight
of
the
high
dose
does
were
significantly
less
than
the
controls
on
GD
20.
Although
this
is
accurate,
it
is
worth
noting
that
the
weight
rebounded
on
GD20
24
and
GD
24
29.
HED's
Response:
This
observation
also
support
the
finding
that
body
weight
decrease
is
treatment
related.
No
change
is
necessary.
1.3.2
Comments
about
Study/
Endpoint:
A
note
in
passing.
There
were
no
effects
observed
at
6
months
for
the
NOEL
of
1.0
mg/
kg/
d.
There
were
also
no
effects
for
this
dose
at
the
12
month
interval
as
well.
1.3.3
No
errors
noted.
1.3.4
No
errors
noted.
1.3.5
No
errors
noted.
1.3.6
Long
Term
Dermal
(
Longer
than
6
Months)
Exposure
Registrant's
Comment:
Dose
and
Endpoint
for
Risk
Assessment.
There
were
also
no
effects
at
the
1.0
mg/
kg/
d
females
at
12
months
exposure.
The
effects
seen
at
24
months
at
this
dose
in
the
female
group
were
compensatory
and
should
be
classified
as
a
NOAEL
rather
than
a
LOAEL.
HED's
Response:
The
LOAEL
was
based
on
evidence
of
hemolytic
anemia
and
compensatory
hematopoiesis
(
decreased
erythrocyte
counts,
increased
reticulocyte
counts,
increased
spleen
weight
and
bone
marrow
activation).
No
change
is
necessary.
1.3.7
No
errors
noted.
1.3.8
Registrant's
Comment:
If
the
LOAEL
were
corrected
to
a
NOAEL,
then
an
MOE
of
100
would
be
appropriate.
HED's
Response:
The
LOAEL
will
not
be
changed
to
a
NOAEL.
2.
Classification
of
Carcinogenic
Potential
2.1
Combined
Chronic
Toxicity/
Carcinogenicity
Study
in
Rats
No
errors.
Although
these
tumors
are
dose
related,
they
are
due
to
a
secondary
mechanism
that
is
not
relevant
to
humans.
2.2
Carcinogenicity
Study
in
Mice
Registrant's
Comment:
Line
1,
Paragraph
1,
of
Discussion
of
Tumor
Data:
Treatment
was
for
104
weeks.
Animals
were
treated
and
sacrificed
after
104
weeks
(
excluding
early
mortality).
Some
confusion
may
have
resulted
since
mortality
tables
were
developed
at
102
weeks,
body
weights
and
clinical
parameters
were
recorded
at
103
weeks.
22
Line
3,
Paragraph
1,
of
Discussion
of
Tumor
Data:
The
reference
to
ovarian
luteomas
should
be
deleted.
This
effect
was
determined
to
be
inconsequential
by
the
CPRC
report
(
May
8,
1997)
which
states:
The
female
mouse
ovarian
tumor
rates
table
should
reflect
the
more
appropriate
'
combined
sex
cord
stromal
tumors'
nomenclature
in
lieu
of
the
'
luteoma'
terminology
used
in
the
qualitative
risk
assessment
(
Lori
L.
Brunsman
to
Linda
L.
Taylor,
11/
20/
96).
Dr.
Lucas
Brennecke,
EPA's
consulting
pathologist,
confirmed
that
the
combined
tumor
counts
are
more
appropriate
than
the
individual
counts
for
ovarian
tumors,
as
it
is
difficult
to
distinguish
between
the
different
types
of
ovarian
tumors.
Since
only
the
luteoma
tumor
counts
have
been
verified,
the
counts
for
the
combined
sex
cord
stromal
tumors
have
been
taken
from
Table
2,
page
3,
of
the
Diuron
data
package,
which
was
extracted
from
the
registrant's
analysis.
Female
mice
do
not
have
a
significant
increasing
trend,
or
any
significant
differences
in
the
pair
wise
comparisons
of
the
dosed
groups
with
the
controls,
for
ovarian
combined
sex
cord
stromal
tumors.
(
from
page7).
Therefore,
Sentence
1
should
read:
"
Treatment
of
up
to
104
weeks
with
2500
ppm
diuron
resulted
in
a
significant
increase
in
the
incidences
of
mammary
adenocarcinomas
(
control,
4%;
2500
ppm,
12%,
p
#
0.05)
in
female
NMRI
(
SPF
HAN)
mice
under
the
conditions
of
this
study."
HED's
Response:
Additional
wording
has
been
added
to
the
document.
See
above
HED's
response
in
the
"
Requirement
870.4200b:
Carcinogenicity
(
feeding)
mouse".
2.3
Classification
of
Carcinogenic
Potential
Registrant's
Comment:
When
the
HED
CPRC
met
on
December
18,
1996,
they
classified
diuron
as
a
`
known/
likely'
carcinogen.
Since
then,
mechanistic
studies
and
additional
genotoxicity
studies
have
been
submitted.
These
need
to
be
evaluated
in
light
of
the
cancer
assessment.
In
addition,
the
classification
`
known/
likely'
is
no
longer
used.
We
would
encourage
the
CARC
to
re
evaluate
the
cancer
classification
of
diuron.
We
believe
the
classification
of
`
known/
likely'
to
be
incorrect.
HED's
Response:
The
HED
Mechanism
of
Toxicity
Assessment
Review
Committee
(
MTARC)
has
evaluated
a
proposed
mode
of
action
submitted
by
the
Registrant
and
concluded
that
the
submitted
information
is
insufficient
to
support
a
mode
of
action
on
bladder
carcinogenicity
for
diuron.
Diuron
will
not
be
re
classified
at
this
time.
3.
Mutagenicity
Registrant's
Comment:
In
addition
to
the
five
studies
previously
submitted
to
the
Agency,
Griffin
LLC
has
supplied
seven
additional
studies
on
June
4,
2001:
1)
Salmonella
typhimurium:
Line
3.
Typographical
error:
Highest
`
does'
should
be
`
dose'.
2)
Chinese
Hamster
Ovary.
No
errors
3)
Chromosome
Aberrations:
Paragraph
1.
This
study
is
the
same
as
the
study
given
as
4)
In
vivo
Bone
Marrow
Cytogenetics
Assay
(
MRID
#
44350301).
This
study
(
MRID#
00146611)
was
revised
with
additional
information
on
historical
background
frequencies.
This
study
can
be
removed
completely.
4)
In
Vivo
Bone
Marrow
Cytogenetics
Assay
(
MRID
#
44350301),
Line
6.
A
sentence
should
be
23
inserted
after
the
sentence
beginning
Cytotoxicity
to
the
target
organ
...
and
ending
...
decreased
at
24
hours.
It
should
read:
There
were
no
statistical
significant
dose
related
increases
observed
in
the
diuron
treated
groups
at
either
6
or
24
hours.
Numerical
designation
of
4)
will
become
3)
after
deletion
of
the
replicate/
revised
study.
5)
Unscheduled
DNA
Synthesis.
No
errors
noted.
Conclusions:
Line
2
6.
Because
these
`
two'
studies
are
actually
the
same
study,
this
sentence
needs
to
be
corrected.
It
should
read:
Diuron
was
not
clastogenic
when
evaluated
by
the
in
vivo
chromosomal
assay
in
Sprague
Dawley
rats.
The
additional
studies
submitted
in
June
further
document
the
negative
genotoxic
response
of
diuron.
These
studies
evaluated
in
vivo
mouse
bone
marrow
micronucleus
formation,
mouse
dominant
lethal
response
and
mouse
spermatogonial
chromosomal
aberrations.
All
were
negative.
(
MRID
#
s
45494501,
45494502,
45494503,
45494504,
and
45494505)
HED's
Response:
All
studies
have
been
reviewed
and
put
into
consideration
for
evaluation
of
mutagenicity.
4.3
Developmental
Toxicity
Registrant's
comment:
Paragraph
3,
General
Comment:
Weight
of
both
males
and
females
rebounded
to
nearly
normal
in
all
dose
groups
after
removal
of
diuron
treatment.
This
should
be
mentioned.
Line
2,
Paragraph
6:
The
number
of
fetuses
examined
in
the
low
dose
was
306
and
not
305.
This
should
read
288(
22),
306(
23),
297(
22)
and
279(
20).
HED's
Response:
See
above
HED's
response
in
the
toxicology
chapter.
4.4
Reproductive
Toxicity
Registrant's
Comment:
Line
3,
Paragraph
1:
Test
substance
intake
should
read
"
Overall
test
substance
intake".
The
dosing
reflects
the
entire
dosing
period.
Line
9,
Paragraph
4:
There
was
not
a
significant
difference
in
the
7
14
day
interval
for
the
females.
HED's
Response:
See
above
HED's
response
in
the
toxicology
chapter.
4.5
Additional
Information
No
errors
noted.
4.6
Determination
of
Susceptibility
No
errors
noted.
4.7
Recommendation
for
a
Developmental
Neurotoxicity
Study
No
errors
noted.
5.
Hazard
Characterization
Registrant's
Comment:
Line
3,
Paragraph
3:
The
NOAELS
for
the
maternal/
parental
toxicity
were
less
than
the
NOAELS
for
fetal
or
reproductive
toxicity.
The
reference
to
equal
can
be
deleted.
HED's
Response:
No
error
noted.
24
Registrant's
Comment:
Paragraph
4,
General
Comment:
There
needs
to
be
a
reassessment
of
the
cancer
classification
of
diuron.
It
is
inconsistent
with
the
care
that
was
taken
by
the
HIARC
to
evaluate
this
chemical
using
current
classifications
of
risk
and
exposure.
The
cancer
classification
of
"
known/
likely"
no
longer
exists.
This
assessment
was
also
performed
without
consideration
of
the
mechanism
of
action
of
diuron.
The
urinary
bladder
and
renal
tumor
(
not
statistically
significant)
carcinoma
is
induced
by
irritation
of
the
urinary
system.
The
mouse
mammary
tumors
observed
are
consistent
with
the
historical
background
incidences.
The
use
of
the
low
dose
linear
extrapolation
model
under
these
circumstances
is
not
warranted.
A
threshold
approach
with
benchmark
reference
doses
is
more
appropriate
given
the
scientific
data.
HED's
Response:
See
above
HED's
response
in
the
toxicology
chapter.
6.
Data
Gaps
No
errors
noted.
7.
Acute
Toxicity
No
errors
noted.
8.
Summary
of
Toxicological
Endpoint
Selection
Registrant's
Comment:
Acute
dietary:
No
errors
noted.
Chronic
Dietary:
The
LOAEL
=
1.0
should
read
LOEL.
There
was
an
absolute
effect.
The
effect
of
anemia
was
compensated
for
by
increased
hematopoiesis.
This
dose
should
be
considered
an
NOAEL
and
not
an
LOAEL.
With
the
establishment
of
an
NOAEL,
a
UF
of
100
could
be
set.
Cancer:
As
indicated
in
discussions
above,
the
classification
of
"
known/
likely"
is
incorrect.
Based
on
the
new
guidelines,
diuron
should
be
classified
as
either
`
unlikely'
or
`
suggestive'.
The
guidelines
properly
assert
that
application
of
a
descriptor
is
a
matter
of
judgement
and
subject
to
gray
areas
and
borderline
cases.
The
final
classification
depends
on
the
weight
that
is
given
to
the
mode
of
action
and
its
human
relevance.
A
new
assessment
needs
to
be
made
that
considers
the
mechanism
of
action.
The
reference
to
the
kidney
carcinoma
needs
to
indicate
that
the
incidence
observed
was
not
statistically
significant.
The
reference
to
the
mammary
gland
carcinoma
in
female
NMRI
mice
should
be
deleted.
The
incidence
is
within
the
historical
range.
Dermal,
Long
term:
As
indicated
in
the
Chronic
Dietary
exposure
scenario,
the
LOAEL
should
be
a
NOAEL.
Inhalation,
Long
term:
As
indicated
in
the
Chronic
Dietary
exposure
scenario,
the
LOAEL
should
be
a
NOAEL.
HED'S
Response:
These
issues
will
be
addressed
in
the
Phase
4
period.
| epa | 2024-06-07T20:31:43.696463 | regulations | {
"license": "Public Domain",
"url": "https://downloads.regulations.gov/EPA-HQ-OPP-2002-0249-0024/content.txt"
} |
EPA-HQ-OPP-2002-0250-0001 | Notice | "2002-12-04T05:00:00" | Fenarimol; Availability of the Risk Assessments on FQPA Tolerance Reassessment Progress and
Tolerance Reassessment Decision (TRED) | 72170
Federal
Register
/
Vol.
67,
No.
233
/
Wednesday,
December
4,
2002
/
Notices
The
sum
of
these
adjustments
is
a
decrease
of
57,855
responses
and
7,134,152
burden
hours
from
the
current
approved
total.
According
to
the
procedures
prescribed
in
5
CFR
1320.12,
EPA
has
submitted
this
ICR
to
OMB
for
review
and
approval.
Any
comments
related
to
the
renewal
of
this
ICR
should
be
submitted
within
30
days
of
this
notice,
as
described
above.
Dated:
November
22,
2002.
Oscar
Morales,
Director,
Collection
Strategies
Division,
Office
of
Environmental
Information.
[
FR
Doc.
02
30762
Filed
12
3
02;
8:
45
am]
BILLING
CODE
6560
50
P
ENVIRONMENTAL
PROTECTION
AGENCY
[
OPP
2002
0250;
FRL
7274
7]
Fenarimol;
Availability
of
the
Risk
Assessments
on
FQPA
Tolerance
Reassessment
Progress
and
Tolerance
Reassessment
Decision
(
TRED)
AGENCY:
Environmental
Protection
Agency
(
EPA).
ACTION:
Notice.
SUMMARY:
This
notice
announces
the
availability
of
EPA's
tolerance
reassessment
decision
and
related
documents
for
fenarimol
including
the
Fenarimol
Overview,
Fenarimol
Summary,
Fenarimol
Decision
Document
(
TRED),
and
supporting
risk
assessment
documents.
EPA
has
reassessed
the
42
tolerances,
or
legal
limits,
for
residues
of
fenarimol
in
or
on
raw
agricultural
commodities.
These
tolerances
are
now
considered
safe
under
the
Federal
Food,
Drug,
and
Cosmetic
Act
(
FFDCA),
as
amended
by
the
Food
Quality
Protection
Act
(
FQPA)
of
1996.
DATES:
Comments
on
the
tolerance
reassessment
decision
or
on
the
human
health
effects
risk
assessment
for
fenarimol,
identified
by
docket
ID
number
OPP
2002
0250,
must
be
received
by
EPA
on
or
before
January
3,
2003.
In
the
absence
of
substantive
comments,
the
tolerance
reassessment
decision
will
be
considered
final.
ADDRESSES:
Comments
may
be
submitted
by
mail,
electronically,
or
in
person.
Please
follow
the
detailed
instructions
for
each
method
as
provided
in
Unit
I.
of
the
SUPPLEMENTARY
INFORMATION.
To
ensure
proper
receipt
by
EPA,
it
is
imperative
that
you
identify
docket
ID
number
OPP
2002
0250
in
the
subject
line
on
the
first
page
of
your
response.
FOR
FURTHER
INFORMATION
CONTACT:
Tom
Myers,
Special
Review
and
Reregistration
Division
(
7508C),
Office
of
Pesticide
Programs,
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460;
telephone
number:
(
703)
308
8589;
email
address:
myers.
tom@
epa.
gov.
SUPPLEMENTARY
INFORMATION:
I.
General
Information
A.
Does
this
Action
Apply
to
Me?
This
action
is
directed
to
the
public
in
general,
but
will
be
of
interest
to
a
wide
range
of
stakeholders,
including
environmental,
human
health,
and
agricultural
advocates;
the
chemical
industry;
pesticide
users;
and
members
of
the
public
interested
in
the
use
of
pesticides.
The
Agency
has
not
attempted
to
describe
all
the
persons
or
entities
who
may
be
interested
in
or
affected
by
this
action.
If
you
have
questions
in
this
regard,
consult
the
person
listed
under
FOR
FURTHER
INFORMATION
CONTACT.
B.
How
Can
I
Get
Additional
Information,
Including
Copies
of
this
Document
and
Other
Related
Documents?
1.
Electronically.
You
may
obtain
electronic
copies
of
this
document,
and
certain
other
related
documents
that
might
be
available
electronically,
from
the
EPA
Internet
Home
Page
at
http://
www.
epa.
gov/.
To
access
this
document,
on
the
Home
Page
select
``
Laws
and
Regulations,''
``
Regulations
and
Proposed
Rules,''
and
then
look
up
the
entry
for
this
document
under
the
``
Federal
Register
Environmental
Documents.''
You
can
also
go
directly
to
the
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Register
listings
at
http://
www.
epa.
gov/
fedrgstr/.
You
can
obtain
copies
of
the
TRED
and
related
documents
discussed
in
this
notice
on
EPA's
website
at
http://
www.
epa.
gov/
pesticides/
reregistration/
status.
htm.
Information
on
pesticide
reregistration
and
tolerance
reassessment,
including
the
purpose
and
status
of
Agency
programs
to
complete
Reregistration
Eligibility
Decisions
(
REDs),
Interim
REDs,
and
tolerance
reassessment
decisions
(
TREDs),
is
available
at
http://
www.
epa.
gov/
pesticides/
reregistration.
General
information
is
available
on
the
Office
of
Pesticide
Programs'
home
page,
http://
www.
epa.
gov/
pesticides/.
2.
In
person.
The
Agency
has
established
an
official
record
for
this
action
under
docket
ID
numbers
OPP
2002
0250.
The
official
record
consists
of
the
documents
specifically
referenced
in
this
action,
and
other
information
related
to
this
action,
including
any
information
claimed
as
Confidential
Business
Information
(
CBI).
This
official
record
includes
the
documents
that
are
physically
located
in
the
docket,
as
well
as
the
documents
that
are
referenced
in
those
documents.
The
public
version
of
the
official
record
does
not
include
any
information
claimed
as
CBI.
The
public
version
of
the
official
record,
which
includes
printed,
paper
versions
of
any
electronic
comments
submitted
during
an
applicable
comment
period
is
available
for
inspection
in
the
Public
Information
and
Records
Integrity
Branch
(
PIRIB),
Rm.
119,
Crystal
Mall
#
2,
1921
Jefferson
Davis
Hwy.,
Arlington,
VA,
from
8:
30
a.
m.
to
4
p.
m.,
Monday
through
Friday,
excluding
legal
holidays.
The
PIRIB
telephone
number
is
(
703)
305
5805.
C.
How
and
to
Whom
Do
I
Submit
Comments?
You
may
submit
comments
through
the
mail,
in
person,
or
electronically.
To
ensure
proper
receipt
by
EPA,
it
is
imperative
that
you
identify
docket
ID
number
OPP
2002
0250
in
the
subject
line
on
the
first
page
of
your
response.
1.
By
mail.
Submit
your
comments
to:
Public
Information
and
Records
Integrity
Branch
(
PIRIB),
Information
Resources
and
Services
Division
(
7502C),
Office
of
Pesticide
Programs
(
OPP),
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460.
2.
In
person
or
by
courier.
Deliver
your
comments
to:
Public
Information
and
Records
Integrity
Branch
(
PIRIB),
Information
Resources
and
Services
Division
(
7502C),
Office
of
Pesticide
Programs
(
OPP),
Environmental
Protection
Agency,
Rm.
119,
Crystal
Mall
#
2,
1921
Jefferson
Davis
Hwy.,
Arlington,
VA.
The
PIRIB
is
open
from
8:
30
a.
m.
to
4
p.
m.,
Monday
through
Friday,
excluding
legal
holidays.
The
PIRIB
telephone
number
is
(
703)
305
5805.
3.
Electronically.
You
may
submit
your
comments
electronically
by
e
mail
to:
opp
docket@
epa.
gov,
or
you
can
submit
a
computer
disk
as
described
in
this
unit.
Do
not
submit
any
information
electronically
that
you
consider
to
be
CBI.
Avoid
the
use
of
special
characters
and
any
form
of
encryption.
Electronic
submissions
will
be
accepted
in
WordPerfect
6.1/
8.0/
9.0
or
ASCII
file
format.
All
comments
in
electronic
form
must
be
identified
by
docket
ID
number
OPP
2002
0250.
Electronic
comments
may
also
be
filed
online
at
many
Federal
Depository
Libraries.
D.
How
Should
I
Handle
CBI
that
I
Want
to
Submit
to
the
Agency?
Do
not
submit
any
information
electronically
that
you
consider
to
be
CBI.
You
may
claim
information
that
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Federal
Register
/
Vol.
67,
No.
233
/
Wednesday,
December
4,
2002
/
Notices
you
submit
to
EPA
in
response
to
this
document
as
CBI
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.
In
addition
to
one
complete
version
of
the
comment
that
includes
any
information
claimed
as
CBI,
a
copy
of
the
comment
that
does
not
contain
the
information
claimed
as
CBI
must
be
submitted
for
inclusion
in
the
public
version
of
the
official
record.
Information
not
marked
confidential
will
be
included
in
the
public
version
of
the
official
record
without
prior
notice.
If
you
have
any
questions
about
CBI
or
the
procedures
for
claiming
CBI,
please
consult
the
person
listed
under
FOR
FURTHER
INFORMATION
CONTACT.
E.
What
Should
I
Consider
as
I
Prepare
My
Comments
for
EPA?
You
may
find
the
following
suggestions
helpful
for
preparing
your
comments:
1.
Explain
your
views
as
clearly
as
possible.
2.
Describe
any
assumptions
that
you
used.
3.
Provide
copies
of
any
technical
information
and/
or
data
you
used
that
support
your
views.
4.
If
you
estimate
potential
burden
or
costs,
explain
how
you
arrived
at
the
estimate
that
you
provide.
5.
Provide
specific
examples
to
illustrate
your
concerns.
6.
Offer
alternative
ways
to
improve
the
notice
or
collection
activity.
7.
Make
sure
to
submit
your
comments
by
the
deadline
in
this
notice.
8.
To
ensure
proper
receipt
by
EPA,
be
sure
to
identify
the
docket
ID
number
assigned
to
this
action
in
the
subject
line
on
the
first
page
of
your
response.
You
may
also
provide
the
name,
date,
and
Federal
Register
citation.
II.
What
Action
is
the
Agency
Taking?
EPA
has
reassessed
the
risks
associated
with
current
food
uses
of
the
pesticide
fenarimol,
reassessed
42
existing
tolerances,
and
reached
a
tolerance
reassessment
and
risk
management
decision.
The
Agency
is
issuing
for
comment
the
resulting
report
on
FQPA
tolerance
reassessment
progress,
including
the
Fenarimol
Overview,
Fenarimol
Summary,
Fenarimol
Decision
Document
(
TRED),
and
supporting
risk
assessment
documents.
EPA
must
review
tolerances
and
tolerance
exemptions
that
were
in
effect
when
FQPA
was
enacted
in
August
1996,
to
ensure
that
these
existing
pesticide
residue
limits
for
food
and
feed
commodities
meet
the
safety
standard
established
by
the
new
law.
Tolerances
are
considered
reassessed
once
the
safety
finding
has
been
made
or
a
revocation
occurs.
EPA
has
reviewed
and
made
the
requisite
safety
finding
for
the
tolerances
and
exemptions
included
in
this
notice.
EPA
approved
registration
of
products
containing
fenarimol
as
an
active
ingredient
prior
to
the
1996
enactment
of
the
Food
and
Quality
Protection
Act;
therefore,
while
no
reregistration
decision
is
required
at
present,
risks
from
non
occupational
exposure
to
fenarimol
through
food,
drinking
water,
and
residential
uses
must
be
reassessed.
The
Agency
has
evaluated
the
dietary
risk
associated
with
fenarimol
and
has
determined
that
there
is
a
reasonable
certainty,
with
appropriate
mitigation,
that
no
harm
to
any
population
subgroup
will
result
from
aggregate
exposure
to
fenarimol
when
considering
dietary
exposure
and
all
other
nonoccupational
sources
of
pesticide
exposure
for
which
there
is
reliable
information.
Residential
postapplication
exposure
was
of
concern
for
children
and
infants
from
fenarimol
products
applied
in
residential
settings.
To
mitigate
this
risk,
the
registrant
has
agreed
to
remove
the
residential
uses
from
their
labels
until
they
conduct
a
special
developmental
toxicity
study
that
will
assess
possible
effects
of
fenarimol
on
the
adult
and
juvenile
rat
hormonal
systems.
Once
these
data
are
submitted
and
reviewed,
the
Agency
will
make
a
determination
regarding
the
reinstatement
of
the
residential
uses.
For
chronic
drinking
water
risk
from
surface
water,
potential
(
average)
estimated
environmental
concentrations
(
EECs)
of
fenarimol
(
84
parts
per
billion
(
ppb))
exceeds
the
chronic
drinking
water
level
of
comparison
(
DWLOC)
for
all
populations.
The
84
ppb
value
includes
all
residential
uses
and
the
golf
course
use
of
fenarimol.
However,
with
the
residential
uses
removed
from
the
label,
a
correction
factor
of
0.31
can
be
applied
to
the
84
ppb
surface
water
number
to
account
for
the
use
of
fenarimol
only
on
tees,
greens,
and
fairways
on
golf
courses.
This
would
reduce
the
chronic
EEC
to
26
ppb.
Infants
and
children,
the
most
sensitive
population
subgroups
would
still
exceed
the
chronic
DWLOC
of
20.
However,
the
chronic
EECs
were
estimated
using
Tier
I
modeling
and
only
slightly
exceed
the
DWLOC.
Additional
data
are
being
required
that
will
provide
important
information
on
the
mobility
of
fenarimol
and
its
degradates.
These
studies
will
help
to
refine
the
chronic
surface
water,
ground
water,
and
drinking
water
risk
assessments.
The
Agency
has
reassessed
all
42
tolerances
for
fenarimol
and
can
make
a
FQPA
safety
determination.
In
addition,
available
residue
chemistry
data
support
the
establishment
of
a
0.02
part
per
million
(
ppm)
permanent
tolerance
for
fenarimol
residues
in
filberts
under
40
CFR
180.421
(
a).
The
Agency
has
sufficient
residue
data
for
reassessing
the
tolerances
for
fenarimol.
The
chronic
dietary
exposure
assessment
for
fenarimol
is
highly
refined
using
anticipated
residues
based
on
1996
1999
Food
and
Drug
Administration
(
FDA)
monitoring
data
for
apples,
bananas,
cherries,
grapes,
and
pears.
Field
trial
residue
data
were
used
for
pecans
and
filberts.
Percent
crop
treated
information
and
processing
factors,
where
available,
were
used
in
the
assessment.
There
were
no
U.
S.
Department
of
Agriculture
Pesticide
Data
Program
monitoring
data
available
for
fenarimol.
Residues
of
fenarimol
per
se
were
non
detectable
(
below
the
method
limit
of
detection
(
LOD))
in
all
1996
1999
FDA
monitoring
samples
of
apples,
bananas,
grapes,
and
pears
(
a
total
of
more
than
3,000
samples).
Out
of
214
cherry
samples,
three
had
detectable
residues.
Residues
of
fenarimol
per
se
were
non
detectable
<
LOD
in/
on
all
but
one
pecan
nut
meat
sample
from
seven
trials.
There
were
no
detectable
residues
in
filbert
samples
from
four
field
trials.
Chronic
dietary
risks
from
exposure
do
not
exceed
the
Agency's
level
of
concern.
EPA
works
with
affected
parties
to
reach
the
tolerance
reassessment
decisions.
The
Agency
therefore
is
issuing
the
fenarimol
decision
as
a
final
decision
with
a
public
comment
period.
All
comments
received
during
the
public
comment
period
will
be
carefully
considered
by
the
Agency.
If
any
comment
significantly
affects
the
Agency's
decision,
EPA
will
publish
an
amendment
to
the
decision
in
the
Federal
Register.
In
the
absence
of
substantive
comments,
the
tolerance
reassessment
decisions
reflected
here
will
be
considered
final.
List
of
Subjects
Environmental
protection,
Chemicals,
Pesticides
and
pests.
Dated:
November
15,
2002.
Betty
Shackleford,
Acting
Director,
Special
Review
and
Reregistration
Division,
Office
of
Pesticide
Programs.
[
FR
Doc.
02
30471
Filed
12
3
02
8:
45
am]
BILLING
CODE
6560
50
S
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| epa | 2024-06-07T20:31:43.715246 | regulations | {
"license": "Public Domain",
"url": "https://downloads.regulations.gov/EPA-HQ-OPP-2002-0250-0001/content.txt"
} |
EPA-HQ-OPP-2002-0250-0002 | Supporting & Related Material | "2002-09-24T04:00:00" | null | UNITED
STATES
ENVIRONMENTAL
PROTECTION
AGENCY
WASHINGTON,
D.
C.
20460
OFFICE
OF
PREVENTION,
PESTICIDES
AND
TOXIC
SUBSTANCES
August
1,
2002
CERTIFIED
MAIL
Cindy
Baker
Gowan
Company
370
S.
Main
Street
PO
Box
5569
Yuma,
AZ
85366
5569
Dear
Ms.
Baker:
This
is
the
Environmental
Protection
Agency's
(
hereafter
referred
to
as
EPA
or
the
Agency)
"
Report
of
the
Food
Quality
Protection
Act
(
FQPA)
Tolerance
Reassessment
Progress
and
Risk
Management
Decision
(
TRED)
for
Fenarimol",
which
was
approved
on
August
1,
2002.
A
Notice
of
Availability
of
this
tolerance
reassessment
decision
will
be
published
in
the
Federal
Register
(
FR).
The
Federal
Food,
Drug
and
Cosmetic
Act
(
FFDCA),
as
amended
by
FQPA,
requires
EPA
to
reassess
all
the
tolerances
for
registered
chemicals
in
effect
on
or
before
the
date
of
the
enactment
of
the
FQPA,
which
was
in
August
of
1996.
In
reassessing
these
tolerances,
the
Agency
must
consider,
among
other
things,
aggregate
risks
from
non
occupational
sources
of
pesticide
exposure,
whether
there
is
increased
susceptibility
to
infants
and
children,
and
the
cumulative
effects
of
pesticides
with
a
common
mechanism
of
toxicity.
Once
a
safety
finding
has
been
made
that
aggregate
risks
are
not
of
concern,
the
tolerances
are
considered
reassessed.
Fenarimol
was
registered
prior
to
FQPA
enactment.
Therefore,
the
tolerances
need
to
be
reassessed
to
meet
the
FQPA
standard.
The
Agency
has
evaluated
the
dietary
risk
associated
with
fenarimol
and
has
determined
that
there
is
a
reasonable
certainty,
with
appropriate
mitigation,
that
no
harm
to
any
population
subgroup
will
result
from
aggregate
exposure
to
fenarimol
when
considering
dietary
exposure
and
all
other
non
occupational
sources
of
pesticide
exposure
for
which
there
is
reliable
information.
Residential
postapplication
exposure
was
of
concern
for
children
and
infants
from
incidental
ingestion
of
fenarimol
product
applied
in
residential
settings.
To
mitigate
this
risk
the
registrant
has
agreed
to
remove
the
residential
uses
from
their
labels
until
they
conduct
a
special
developmental
toxicity
study
that
will
assess
for
possible
effects
of
fenarimol
on
the
adult
and
juvenile
rat
hormonal
systems.
Once
these
data
are
submitted
and
reviewed,
the
Agency
will
make
a
determination
regarding
the
acceptability
of
the
residential
uses.
2
For
chronic
drinking
water
risk
from
surface
water,
potential
(
average)
Estimated
Environmental
Concentrations
(
EECs)
of
fenarimol
(
84
ppb)
exceeds
the
chronic
Drinking
Water
Level
of
Comparison
(
DWLOC)
for
all
populations.
The
84
ppb
value
includes
all
residential
uses
and
the
golf
course
use
of
fenarimol.
However,
with
the
residential
uses
removed
from
the
label
a
correction
factor
of
.31
can
be
applied
to
the
84
ppb
surface
water
number
to
account
for
the
use
of
fenarimol
only
on
tees,
greens,
and
fairways
on
golf
courses.
This
would
reduce
the
chronic
EEC
to
26
ppb.
Infants
and
children,
the
most
sensitive
population
subgroups
would
still
exceed
the
chronic
DWLOC
of
20.
However,
the
chronic
EECs
were
estimated
using
Tier
I
modeling
and
only
slightly
exceed
the
DWLOC.
Additional
data
are
being
required
that
will
provide
important
information
on
the
mobility
of
fenarimol
and
its
degradates.
These
studies
will
help
to
refine
the
chronic
surface
and
ground
water
drinking
water
risk
assessments.
FQPA
requires
that
EPA
consider
"
available
information"
concerning
the
cumulative
effects
of
a
particular
pesticide's
residues
and
"
other
substances
that
have
a
common
mechanism
of
toxicity."
The
reason
for
considering
other
substances
is
because
of
the
possibility
that
low
level
exposures
to
multiple
chemical
substances
that
cause
a
common
toxic
effect
by
a
common
mechanism
could
lead
to
the
same
adverse
health
effect,
as
would
a
higher
level
of
exposure
to
any
of
the
other
substances
individually.
EPA
did
not
perform
a
cumulative
risk
assessment
as
part
of
this
review
of
fenarimol,
because
the
Agency
has
not
determined
that
there
are
any
other
chemical
substances
that
have
a
mechanism
of
toxicity
common
with
that
of
fenarimol.
If
EPA
identifies
other
substances
that
share
a
common
mechanism
of
toxicity
with
fenarimol,
then
a
cumulative
risk
assessment
will
be
conducted
that
includes
fenarimol
once
the
final
framework
EPA
will
use
for
conducting
cumulative
risk
assessments
is
available.
Further,
EPA
is
in
the
process
of
developing
criteria
for
characterizing
and
testing
endocrine
disrupting
chemicals
and
plans
to
implement
an
Endocrine
Disruptor
Screening
Program.
Fenarimol
will
be
reevaluated
at
that
time
and
additional
studies
may
be
requested.
The
Agency's
human
health
findings
for
the
pesticide
fenarimol,
are
summarized
in
the
enclosed
Fenarimol
Overview
and
Fenarimol
Summary
of
the
risk
assessments.
The
risk
assessments
and
other
documents
pertaining
to
the
fenarimol
tolerance
reassessment
decision
are
available
on
the
Internet
at
http://
www.
epa.
gov/
pesticides/
reregistration/
status.
htm
and
are
in
the
public
docket
for
viewing.
The
Agency
has
reassessed
all
42
tolerances
for
fenarimol
and
can
make
a
FQPA
safety
determination.
In
addition,
available
residue
chemistry
data
support
the
establishment
of
a
0.02
ppm
permanent
tolerance
for
fenarimol
residues
in
filberts
under
40
CFR
180.421
(
a).
The
Agency
has
sufficient
residue
data
for
reassessing
the
tolerances
for
fenarimol.
The
chronic
dietary
exposure
assessment
for
fenarimol
is
highly
refined
using
anticipated
residues
based
on
1996
1999
Food
and
Drug
Administration
(
FDA)
monitoring
data
for
apples,
bananas,
cherries,
grapes
and
pears.
Field
trial
residue
data
were
used
for
pecans
and
filberts.
Percent
crop
treated
(%
CT)
information
and
processing
factors,
where
available,
were
used
in
the
assessment.
There
were
no
PDP
monitoring
data
available
for
fenarimol.
Residues
of
fenarimol
per
se
were
nondetectable
(
below
the
method
limit
of
detection,
or
LOD)
in
all
1996
1999
FDA
monitoring
samples
of
apples,
bananas,
grapes,
and
pears
(
a
total
of
more
than
3,000
samples).
Out
of
214
cherry
samples,
three
had
detectable
residues.
Residues
of
fenarimol
per
se
were
nondetectable
(<
LOD)
in/
on
all
but
one
pecan
nut
meat
sample
from
seven
trials.
There
were
no
detectable
residues
in
filbert
samples
from
four
field
trials.
Chronic
dietary
risks
from
exposure
do
not
exceed
the
Agency's
level
of
concern.
3
Table
1
Tolerance
Reassessment
Summary
For
Fenarimol.
Commodity
Established
Tolerance
(
ppm)
Reassessed
Tolerance
(
ppm)
Comment
[
Correct
Commodity
Definition]
Tolerance
Listed
Under
40
CFR
§
180.421(
a)(
1)
Apple
pomace
(
wet
and
dry)
2.0
0.3
The
available
data
indicate
that
the
tolerance
for
wet
apple
pomace
should
be
reduced.
Dry
apple
pomace
is
no
longer
considered
a
significant
livestock
feed
item.
[
Apple,
wet
pomace]
Apples
0.1
0.1
[
Apple]
Cattle,
fat
0.1
0.01
Residue
data
indicate
that
the
tolerance
should
be
reassessed
at
0.01
ppm
(
method
limit
of
quantitation
[
LOQ]).
Cattle,
meat
0.01
0.01
Residue
data
indicate
that
the
tolerance
should
be
reassessed
at
0.01
ppm
(
method
limit
of
quantitation
[
LOQ]).
Cattle,
mbyp
0.01
0.05
[
Cattle,
meat
byproducts,
except
kidney]
Residue
data
indicate
that
the
tolerance
should
be
reassessed
at
0.05
ppm.
Cattle,
kidney
0.1
0.01
Residue
data
indicate
that
the
tolerance
should
be
reassessed
at
0.01
ppm
(
method
limit
of
quantitation
[
LOQ]).
Cattle,
liver
0.1
Revoke
[
included
in
meat
byproducts]
Eggs
0.01
Revoke
There
are
no
poultry
feed
items
associated
with
presently
registered
uses.
Goat,
fat
0.1
0.01
Residue
data
indicate
that
the
tolerance
should
be
reassessed
at
0.01
ppm
(
method
limit
of
quantitation
[
LOQ]).
Goat,
meat
0.01
0.01
Residue
data
indicate
that
the
tolerance
should
be
reassessed
at
0.01
ppm
(
method
limit
of
quantitation
[
LOQ]).
Goat,
mbyp
0.01
0.05
[
Goat,
meat
byproducts,
except
kidney]
Residue
data
indicate
that
the
tolerance
should
be
reassessed
at
0.05
ppm.
Goat,
kidney
0.1
0.01
Residue
data
indicate
that
the
tolerance
should
be
reassessed
at
0.01
ppm
(
method
limit
of
quantitation
[
LOQ]).
Goat,
liver
0.1
Revoke
[
included
in
meat
byproducts]
Commodity
Established
Tolerance
(
ppm)
Reassessed
Tolerance
(
ppm)
Comment
[
Correct
Commodity
Definition]
4
Hog,
fat
0.1
Revoke
There
are
no
hog
feed
items
associated
with
presently
registered
uses.
Hog,
meat
0.01
Revoke
Hog,
mbyp
0.01
Revoke
Hog,
kidney
0.1
Revoke
Hog,
liver
0.1
Revoke
Horse,
fat
0.1
0.01
Residue
data
indicate
that
the
tolerance
should
be
reassessed
at
0.01
ppm
(
method
limit
of
quantitation
[
LOQ]).
Horse,
meat
0.01
0.01
Residue
data
indicate
that
the
tolerance
should
be
reassessed
at
0.01
ppm
(
method
limit
of
quantitation
[
LOQ]).
Horse,
mbyp
0.01
0.05
[
Horse,
meat
byproducts,
except
kidney]
Residue
data
indicate
that
the
tolerance
should
be
reassessed
at
0.05
ppm.
Horse,
liver
0.1
Revoke
[
included
in
meat
byproducts]
Horse,
kidney
0.1
0.01
Residue
data
indicate
that
the
tolerance
should
be
reassessed
at
0.01
ppm
(
method
limit
of
quantitation
[
LOQ]).
Milk
0.003
Revoke
Category
3
of
40
CFR
§
180.6(
a)
Pears
0.1
0.1
[
Pear]
Pecans
0.1
0.02
[
Pecan]
Residue
data
have
been
submitted
to
reassess
the
established
tolerance
for
pecans.
Poultry,
fat
0.01
Revoke
There
are
no
poultry
feed
items
associated
with
presently
registered
uses.
Poultry,
meat
0.01
Revoke
Poultry,
mbyp
0.01
Revoke
Sheep,
fat
0.1
0.01
Residue
data
indicate
that
the
tolerance
should
be
reassessed
at
0.01
ppm
(
method
limit
of
quantitation
[
LOQ]).
Sheep,
meat
0.01
0.01
Residue
data
indicate
that
the
tolerance
should
be
reassessed
at
0.01
ppm
(
method
limit
of
quantitation
[
LOQ]).
Sheep,
mbyp
0.01
0.05
[
Sheep,
meat
byproducts,
except
kidney]
Residue
data
indicate
that
the
tolerance
should
be
reassessed
at
0.05
ppm.
Commodity
Established
Tolerance
(
ppm)
Reassessed
Tolerance
(
ppm)
Comment
[
Correct
Commodity
Definition]
5
Sheep,
kidney
0.1
0.01
Residue
data
indicate
that
the
tolerance
should
be
reassessed
at
0.01
ppm
(
method
limit
of
quantitation
[
LOQ]).
Sheep,
liver
0.1
Revoke
[
included
in
meat
byproducts]
Tolerance
Listed
Under
40
CFR
§
180.421(
a)(
2)
Bananas
1
0.5
(
Not
more
than
0.25
ppm
shall
be
present
in
the
pulp
after
peel
is
removed)
0.25
[
Banana]
Residue
data
have
been
submitted
to
reassess
the
established
tolerance
for
bananas.
Cherries
1.0
1.0
[
Cherry]
Grape
juice
0.6
Revoke
Not
required
based
on
reexamination
of
available
grape
processing
data.
Grape
pomace
(
wet
and
dry)
2.0
Revoke
No
longer
considered
a
significant
livestock
feed
item.
Grapes
0.2
0.1
[
Grape]
Residue
data
have
been
submitted
to
reassess
the
established
tolerance
for
grapes.
Raisin
waste
3.0
Revoke
No
longer
considered
a
significant
livestock
feed
item.
Raisins
0.6
Revoke
Not
required
based
on
reexamination
of
available
grape
processing
data.
Tolerance
to
be
Established
Under
40
CFR
§
180.421(
a)(
1)
Filberts
not
applicable
0.02
Residue
chemistry
data
support
the
establishment
of
a
0.02
ppm
tolerance
for
filberts.
1
For
tolerance
reassessment
purposes,
the
banana
tolerance
is
counted
as
two
tolerances
to
reflect
the
baseline
count
determined
at
the
start
of
FQPA
(
bananas
and
bananas,
pulp).
Codex/
International
Harmonization
The
Codex
Alimentarius
Commission
has
established
several
maximum
residue
limits
(
MRLs)
for
residues
of
fenarimol
in/
on
various
raw
agricultural
and
processed
commodities.
The
Codex
MRLs
are
expressed
in
terms
of
fenarimol
per
se.
A
numerical
comparison
of
the
Codex
MRLs
and
the
corresponding
reassessed
U.
S.
tolerances
is
presented
in
the
Table
below.
The
Table
shows
that
except
for
cattle
liver,
cherries,
and
pecans,
the
U.
S.
tolerances
and
Codex
MRLs
are
not
in
harmony
with
respect
to
numerical
levels.
6
Table
2
Codex
MRLs
and
applicable
U.
S.
tolerances
for
fenarimol.
Recommendations
are
based
on
conclusions
following
reassessment
of
U.
S.
tolerances.
Codex
Reassessed
U.
S.
Tolerance,
ppm
Recommendation
And
Comments
Commodity,
As
Defined
MRL
1
(
mg/
kg)
Apple
pomace,
dry
5
wet
apple
pomace
=
0.3
Dry
apple
pomace
is
no
longer
considered
a
significant
livestock
feed
item.
Artichoke
globe
0.1
Banana
0.2
0.25
Cattle
kidney
0.02
(*)
0.01
(*)
Cattle
liver
0.05
Revoke
covered
by
tolerance
for
meat
byproducts
Cattle
meat
0.02
(*)
0.01
(*)
Cherries
1
1
Dried
grapes
(
currants,
raisins
and
sultanas)
0.2
Revoke
Grapes
0.3
0.1
Hops,
dry
5
Melons,
except
watermelon
0.05
Peach
0.5
Pecan
0.02
(*)
0.02
(*)
Peppers,
sweet
0.5
Pome
fruits
0.3
apple/
pear
=
0.1
Strawberry
1
1
All
MRLs
are
at
CXL
step.
An
asterisk
(*)
signifies
that
the
MRL
or
US
tolerance
was
established
at
or
about
the
limit
of
detection.
Note
that
you
will
be
sent
a
Section
3(
c)(
2)(
B)
Data
Call
In
(
DCI)
letter
under
the
Federal
Insecticide,
Fungicide,
Rodenticide
Act
(
FIFRA)
in
a
separate
mailing.
If
you
have
questions
on
this
document,
please
contact
the
Chemical
Review
Manager,
Tom
Myers,
at
(
703)
308
8589.
Sincerely,
Lois
A.
Rossi,
Director
Special
Review
and
Reregistration
Division
Enclosures:
"
Fenarimol
Overview"
and
"
Fenarimol
Summary"
| epa | 2024-06-07T20:31:43.720085 | regulations | {
"license": "Public Domain",
"url": "https://downloads.regulations.gov/EPA-HQ-OPP-2002-0250-0002/content.txt"
} |
EPA-HQ-OPP-2002-0250-0003 | Supporting & Related Material | "2002-09-24T04:00:00" | null | Fenarimol
Summary
Uses
$
Fenarimol
is
a
fungicide
registered
for
use
on
apples,
bananas,
cherries,
filberts,
grapes,
pears,
pecans.
It
is
also
registered
for
use
on
ornamental
plants,
trees,
and
residential/
recreational
turf.
Fenarimol
is
a
systemic
fungicide
that
inhibits
fungal
growth.
$
Fenarimol
is
formulated
as
a
flowable
concentrate,
granular,
soluble
concentrate/
liquid,
and
emulsifiable
concentrate.
Fenarimol
can
be
applied
by
a
belly
grinder,
push
type
spreader,
and
low
or
high
volume
ground
sprayers.
$
For
treating
fruit
and
nut
trees,
the
maximum
fenarimol
application
rate
is
0.09375
lb
ai/
A.
For
the
turf
use,
the
maximum
rate
is
2.73
lb
ai/
A.
$
Approximately
61,000
pounds
of
fenarimol
active
ingredient
are
used
in
the
U.
S.
annually.
The
turf
use
comprises
28%
or
approximately
17,000
pounds
of
the
total
use.
Health
Effects
Fenarimol
has
moderate
acute
toxicity.
The
developmental
and
reproductive
toxicity
studies
showed
no
evidence
of
increased
sensitivity
or
susceptibility
of
young
rats
or
rabbits
following
pre
or
postnatal
exposure
to
fenarimol.
$
In
the
rat
multi
generation
reproduction
studies
there
was
an
inhibition
of
aromatase.
Aromatase,
also
known
as
estrogen
synthetase,
is
the
key
enzyme
for
the
conversion
of
androgens
to
estrogens
and
is
therefore
a
potentially
critical
enzyme
in
maintaining
hormone
balance
in
human
physiology.
$
The
multi
generation
reproduction
studies
indicate
that
fenarimol
causes
reduced
fertility
and
dystocia
(
difficult
labor).
These
effects
of
fenarimol
were
demonstrated
to
be
attributed
to
inhibition
of
aromatase
in
adult
animals.
$
The
10x
FQPA
Safety
Factor
has
been
reduced
to
3x
to
account
for
the
potential
increased
sensitivity
of
young
organisms
to
the
hormonal
effects
elicited
by
fenarimol's
inhibition
of
aromatase.
Dietary
Risks
$
No
appropriate
endpoint
was
identified
to
estimate
risk
from
a
single
dose
of
fenarimol.
Therefore,
an
acute
dietary
exposure
assessment
was
not
performed.
2
$
Based
on
highly
refined
analyses,
chronic
dietary
risk
from
exposure
to
fenarimol
is
low
(<
1%
of
the
Population
Adjusted
Dose)
for
all
populations
and
is
below
the
Agency's
level
of
concern.
Drinking
Water
Risks
$
Based
on
SCI
GROW
(
Tier
I)
modeling
for
ground
water,
the
chronic
EECs
are
below
the
DWLOCs
for
all
populations
indicating
that
chronic
exposure
to
fenarimol
in
ground
water
is
not
of
concern.
$
Based
on
FIRST
(
Tier
I)
modeling
for
surface
water,
using
the
highest
application
rate
for
turf,
the
chronic
EECs
exceeds
the
DWLOC
for
all
populations
indicating
that
chronic
exposure
to
fenarimol
in
surface
water
is
potentially
of
concern.
$
The
EECs
for
surface
and
ground
water
are
based
on
upper
end
input
parameters
such
as
87%
of
a
watershed
being
treated
at
the
maximum
application.
$
Additional
data
are
being
required
that
will
provide
important
information
on
the
mobility
of
fenarimol
and
its
degradates.
These
studies
may
help
to
refine
the
assessment.
Residential
Postapplication
Risks
$
A
Margin
of
Exposure
(
MOE),
of
greater
than
900
does
not
exceed
the
Agency's
level
of
concern
for
residential
postapplication
risk.
$
Risk
estimates
for
dermal
contact
with
treated
turf
during
high
contact
lawn
activities
exceed
the
Agency's
level
of
concern
(
MOEs
<
900)
for
children
with
an
MOE
of
660.
$
Risk
estimates
for
dermal
contact
with
treated
turf
on
the
day
of
treatment
do
not
exceed
the
level
of
concern
for
adults
during
the
low
contact
activities
of
grass
mowing
(
MOE
=
27,000)
or
golfing
(
MOE
=
14,000).
$
Risk
estimates
for
small
children
from
non
dietary
hand
to
mouth
activities
indicate
that
risks
slightly
exceed
the
level
of
concern
(
MOE
860).
$
Incidental
ingestion
of
soil
(
MOE
=
260,000)
and
incidental
turfgrass
mouthing
(
MOE
=
3400)
did
not
exceed
the
level
of
concern
$
The
small
children's
combined
oral
hand
to
mouth
scenarios
exceeds
the
level
of
concern
(
MOE
=
690).
When
risk
estimates
to
small
children
from
short
term
dermal
exposures
are
combined
with
risk
estimates
from
all
incidental
oral
exposures
the
combined
short
term
risk
estimate
exceeds
the
level
of
concern
(
MOE
=
340).
3
Aggregate
Risks
$
The
aggregate
risk
assessment
for
fenarimol
examines
the
combined
risk
from
exposure
through
food,
drinking
water,
and
residential
exposures
where
applicable.
$
Because
an
acute
toxicity
endpoint
was
not
identified,
an
acute
aggregate
risk
assessment
is
not
required.
$
The
registrants
have
agreed
to
remove
residential
uses
from
their
labels
while
data
are
developed
to
address
uncertainty
related
to
effects
on
children.
Thus,
aggregate
risk
has
been
recalculated
excluding
exposure
from
residential
use.
$
For
the
short
term
aggregate
risk
assessment
dermal
postapplication
exposure
for
adult
golfers
was
combined
with
the
average
dietary
(
food
&
water)
exposures.
The
short
term
DWLOCs
for
adult
males
and
females
are
well
above
the
estimated
EECs
for
ground
and
surface
water
indicating
that
combined
short
term
dietary
(
food
&
water)
and
dermal
exposures
do
not
exceed
the
Agency's
level
of
concern.
$
The
EEC
for
surface
water
(
26
ppb)
slightly
exceeds
the
DWLOC
(
20
ppb)
for
children
under
6.
However,
the
estimated
EEC
for
surface
water
is
a
very
conservative
estimate.
Also,
given
the
relatively
low
usage
of
fenarimol
across
the
country
it
is
highly
unlikely
that
the
amount
applied
to
the
watershed
in
the
model
will
be
concentrated
in
any
real
watershed
used
to
derive
drinking
water.
$
The
EEC
for
ground
water
is
less
than
all
DWLOCs;
therefore,
there
is
no
concern
for
aggregate
chronic
exposure
to
fenarimol
and
its
degradates
from
food
and
drinking
water
derived
from
ground
water.
Occupational
and
Ecological
Risks
$
Because
fenarimol
is
under
review
for
tolerance
reassessment
only,
no
occupational
or
ecological
risk
assessment
was
conducted.
| epa | 2024-06-07T20:31:43.723969 | regulations | {
"license": "Public Domain",
"url": "https://downloads.regulations.gov/EPA-HQ-OPP-2002-0250-0003/content.txt"
} |
EPA-HQ-OPP-2002-0250-0004 | Supporting & Related Material | "2002-09-24T04:00:00" | null | OVERVIEW
OF
FENARIMOL
RISK
ASSESSMENT
Introduction
This
document
presents
an
overview
of
EPA's
human
health
findings
and
conclusions
for
the
fungicide
fenarimol,
as
presented
fully
in
the
documents:"
Fenarimol:
HED
Human
Health
Assessment
for
the
Tolerance
Reassessment
Eligibility
Decision
(
TRED),"
dated
February
12,
2002,
and
"
Drinking
Water
Assessment
to
Support
TRED
for
fenarimol,"
dated
August
6,
2001.
The
purpose
of
this
overview
is
to
assist
the
reader
by
identifying
the
key
features
and
findings
of
this
risk
reassessment
in
order
to
better
understand
the
conclusions
reached
in
the
tolerance
reassessment.
This
overview
was
developed
in
response
to
comments
and
requests
from
the
public,
which
indicated
that
the
risk
assessments
were
difficult
to
understand,
that
they
were
too
lengthy,
and
that
it
was
not
easy
to
compare
the
assessments
for
different
chemicals
due
to
the
use
of
different
formats.
The
Federal
Food,
Drug,
and
Cosmetic
Act
(
FFDCA),
as
amended
by
the
Food
Quality
Protection
Act
(
FQPA)
of
1996,
requires
EPA
to
review
all
the
tolerances
for
registered
chemicals
in
effect
on
or
before
the
date
of
the
enactment
of
FQPA.
In
reviewing
these
tolerances,
the
Agency
must
consider,
among
other
things,
aggregate
risks
from
non
occupational
sources
of
pesticide
exposure,
whether
there
is
increased
susceptibility
to
infants
and
children,
and
the
cumulative
effects
of
pesticides
with
a
common
mechanism
of
toxicity.
The
tolerances
are
considered
reassessed
once
the
safety
finding
has
been
made
or
a
revocation
occurs.
FQPA
stipulates
that
when
determining
the
safety
of
a
pesticide
chemical,
EPA
shall
base
its
assessment
of
the
risk
posed
by
the
chemical
on,
among
other
things,
available
information
concerning
the
cumulative
effects
to
human
health
that
may
result
from
dietary,
residential,
or
other
non
occupational
exposure
to
other
substances
that
have
a
common
mechanism
of
toxicity.
The
reason
for
consideration
of
other
substances
is
due
to
the
possibility
that
low
level
exposures
to
multiple
chemical
substances
that
cause
a
common
toxic
effect
by
a
common
mechanism
could
lead
to
the
same
adverse
health
effect
as
would
a
higher
level
of
exposure
to
any
of
the
substances
individually.
A
person
exposed
to
a
pesticide
at
a
level
that
is
considered
safe
may
in
fact
experience
harm
if
that
person
is
also
exposed
to
other
substances
that
cause
a
common
toxic
effect
by
a
mechanism
common
with
that
of
the
subject
pesticide,
even
if
the
individual
exposure
levels
to
the
other
substances
are
also
considered
safe.
EPA
did
not
perform
a
cumulative
risk
assessment
as
part
of
the
Tolerance
Reassessment
Decision
(
TRED)
for
fenarimol
because
the
Agency
has
not
yet
initiated
a
comprehensive
review
to
determine
if
there
are
any
other
chemical
substances
that
have
a
mechanism
of
toxicity
common
with
that
of
fenarimol.
For
purposes
of
this
risk
assessment,
EPA
has
assumed
that
fenarimol
does
not
have
a
common
mechanism
of
toxicity
with
other
substances.
In
the
future,
the
registrant
may
be
asked
to
submit,
upon
EPA's
request
and
according
to
2
a
schedule
determined
by
the
Agency,
such
information
as
the
Agency
directs
to
be
submitted
in
order
to
evaluate
issues
related
to
whether
fenarimol
shares
a
common
mechanism
of
toxicity
with
any
other
substance
and,
if
so,
whether
any
tolerances
for
fenarimol
need
to
be
modified
or
revoked.
The
Agency
has
developed
a
framework
for
conducting
cumulative
risk
assessments
on
substances
that
have
a
common
mechanism
of
toxicity.
This
guidance
was
issued
on
January
16,
2002
(
67
FR
2210
2214)
and
is
available
from
the
OPP
Website
at:
http://
www.
epa.
gov/
pesticides/
trac/
science/
cumulative_
guidance.
pdf.
The
risk
assessment,
and
documents
pertaining
to
the
Agency's
report
on
FQPA
tolerance
reassessment
progress
and
risk
management
decision
for
fenarimol
are
available
on
the
Internet
at
http://
www.
epa.
gov/
pesticides/
reregistration/
status.
htm
and
in
the
public
docket
for
viewing.
The
Agency's
report
on
FQPA
tolerance
reassessment
progress
and
risk
management
decision
for
fenarimol
will
be
announced
in
the
Federal
Register.
Use
Profile
$
Fungicide:
Fenarimol
is
registered
for
treatment
of
apples,
bananas,
cherries,
filberts,
grapes,
pears,
pecans.
It
is
also
registered
for
use
on
ornamental
plants,
trees,
and
residential/
recreational
turf.
Fenarimol
is
a
systemic
fungicide
that
inhibits
fungal
growth.
$
Formulations:
Formulated
as
flowable
concentrate
(
2.4%
ai),
granular
(
0.78%
ai,
turf
use
only),
soluble
concentrate
(
11.6%
ai),
and
emulsifiable
concentrates
(
12%
ai).
$
Methods
of
Application:
Granules
can
be
applied
by
hand
or
by
granule
applicator
(
belly
grinder,
push
type
spreader).
Other
formulations
are
applied
by
high
or
low
volume
ground
sprayers.
$
Use
Rates:
The
maximum
rate
for
fruit
and
nut
trees
is
0.09375
lb
ai/
A.
The
maximum
rate
for
ornamentals
is
0.34
lb/
350
gal.
The
maximum
rate
for
turf
is
2.73
lb
ai/
A.
$
Registrants:
Gowan
Company,
Riverdale,
and
Leesco.
$
Use
Summary:
Total
annual
domestic
use
averages
approximately
61,000
thousand
pounds
of
active
ingredient.
The
largest
markets,
in
terms
of
total
pounds
active
ingredient
are
apples
(
33%),
nursery
outdoors
(
20%),
turf
for
lawn
(
16%),
and
turf
for
golf
courses
(
12%).
The
remaining
usage
is
primarily
on
raisin
and
wine
grapes,
almonds,
cherries,
hazelnuts,
and
pears.
Crops
with
a
high
percentage
of
the
total
U.
S.
planted
acres
treated
include
apples
(
25%),
sweet
cherries
(
13%),
tart
cherries,
wine
grapes,
and
hazelnuts
(
9%
each),
and
table
grapes
(
8%).
3
Human
Health
Risk
Assessment
Acute
Dietary
Risk
(
Food)
No
appropriate
endpoint
was
identified
in
the
toxicological
data
base
to
estimate
risk
from
a
single
dose
administration
of
fenarimol.
Therefore,
an
acute
dietary
exposure
assessment
was
not
performed.
Chronic
Dietary
Risk
(
Food)
(
For
a
complete
discussion,
see
section
4.2
of
the
Human
Health
Risk
Assessment)
Chronic
dietary
risk
is
calculated
by
using
the
average
consumption
value
for
food
and
average
residue
values
on
those
foods
over
a
70
year
lifetime.
A
risk
estimate
that
is
less
than
100%
of
the
chronic
RfD
(
the
dose
at
which
an
individual
could
be
exposed
over
the
course
of
a
lifetime
and
no
adverse
health
effects
would
be
expected)
does
not
exceed
the
Agency's
level
of
concern.
The
cPAD
is
the
chronic
reference
dose
(
cRfD)
adjusted
for
the
FQPA
Safety
Factor.
Chronic
risk
estimates
from
exposures
to
food
do
not
exceed
the
Agency's
level
of
concern.
The
chronic
dietary
(
food
only)
risk
estimate
is
<
1%
of
the
cPAD,
for
the
U.
S.
Population
and
all
subpopulations.
This
is
not
surprising
based
on:
the
lack
of
detectable
residues
for
many
commodities
in
the
FDA
monitoring
data;
no
residues
expected
in
milk,
poultry
and
hogs;
and,
low
anticipated
residues
for
cattle
meat,
fat,
and
meat
by
products.
$
The
toxicity
endpoint
for
the
chronic
dietary
assessment
is
decreased
live
born
litter
size
in
the
F
1
and
F
2
generations
based
on
the
results
of
a
rat
reproduction
study
(
NOAEL
=
0.6
mg/
kg/
day).
These
effects
were
observed
at
1.2
mg/
kg/
day
(
LOAEL).
$
The
Uncertainty
Factor
is
100x;
10x
for
inter
species
variation
and
10x
for
intra
species
extrapolation.
$
The
10x
FQPA
Safety
Factor
has
been
reduced
to
3x
for
chronic
exposure
scenarios
to
account
for
the
potential
increased
sensitivity
of
young
organisms
to
the
hormonal
effects
elicited
by
fenarimol's
inhibition
of
aromatase.
$
The
chronic
dietary
exposure
assessment
for
fenarimol
is
highly
refined
using
anticipated
residues
based
on
1996
1999
Food
and
Drug
Administration
(
FDA)
monitoring
data
for
apples,
bananas,
cherries,
grapes
and
pears.
Field
trial
residue
data
were
used
for
pecans
and
filberts.
Percent
crop
treated
(%
CT)
information
and
processing
factors,
where
4
available,
were
used.
There
were
no
PDP
monitoring
data
available
for
fenarimol.
$
The
chronic
Population
Adjusted
Dose
(
cPAD)
is
0.002
mg/
kg/
day
(
chronic
RfD
0.006
mg/
kg/
day
÷
3x
FQPA
safety
factor).
$
Drinking
Water
Dietary
Risk
(
For
a
complete
discussion,
see
section
4.3
of
the
Human
Health
Risk
Assessment)
Drinking
water
exposure
to
pesticides
can
occur
through
groundwater
and
surface
water
contamination.
EPA
considers
both
acute
(
one
day)
and
chronic
(
lifetime)
drinking
water
risks
and
uses
either
modeling
or
actual
monitoring
data,
if
available,
to
estimate
those
risks.
To
determine
the
maximum
allowable
contribution
of
treated
water
allowed
in
the
diet,
EPA
first
looks
at
how
much
of
the
overall
allowable
risk
is
contributed
by
food,
then
calculates
a
"
drinking
water
level
of
comparison"
(
DWLOC)
to
determine
whether
modeled
or
monitoring
concentrations
exceed
this
level.
The
DWLOCs
represent
the
maximum
contribution
to
the
human
diet
(
in
ppb
or
µ
g/
L)
that
may
be
attributed
to
residues
of
a
pesticide
in
drinking
water
after
dietary
exposure
is
subtracted
from
the
aPAD
or
cPAD.
Risks
from
drinking
water
are
assessed
by
comparing
the
DWLOCs
to
the
estimated
environmental
concentrations
(
EECs)
in
surface
water
and
groundwater.
Drinking
water
modeling
is
considered
to
be
an
unrefined
assessment
and
provides
high
end
estimates.
Modeling
provides
a
screening
level
assessment,
using
conservative
assumptions
to
estimate
high
end
average
concentrations
(
EECs)
of
fenarimol
in
surface
water
and
groundwater.
$
An
acute
toxicity
endpoint
was
not
identified,
therefore,
an
acute
drinking
water
exposure
assessment
was
not
required.
$
Comparison
of
the
chronic
DWLOCs
with
the
chronic
EECs,
average
concentrations
of
fenarimol
in
surface
water
are
greater
than
the
DWLOCs
for
all
populations
indicating
a
concern
based
on
the
application
rate
to
turf.
$
The
chronic
surface
water
value
of
84
ppb
includes
all
residential
uses
and
the
golf
course
use
of
fenarimol.
However,
with
the
residential
uses
removed
from
the
label
a
correction
factor
of
.31
can
be
applied
to
the
84
ppb
surface
water
number
to
account
for
the
use
of
fenarimol
only
on
tees,
greens,
and
fairways
on
golf
courses.
This
would
reduce
the
chronic
EEC
to
26
ppb.
$
For
groundwater,
the
EECs
are
below
the
DWLOCs
for
all
populations
indicating
that
chronic
exposure
to
fenarimol
in
ground
water
is
not
of
concern.
5
Table
1
Fenarimol
Comparison
of
Chronic
DWLOC
and
EEC
Calculations
(
turf
uses)
Population
Subgroup
Chronic
DWLOC
Estimated
Environmental
Concentrations
Surface
Water
(
Chronic)
(
ppb)
Ground
Water
(
SCI
GROW)
(
ppb)
U.
S.
Population
70
ppb
84
ppb
(
with
residential
and
golf
course
turf
uses)
26
ppb
(
with
residential
uses
removed
and
only
golf
course
use
remaining)
16
Females
13
50
yrs
60
ppb
Children
1
6
yrs
20
ppb
All
Infants
20
ppb
$
Estimated
drinking
water
concentrations
for
ground
water
are
based
on
the
SCI
GROW
model,
which
is
a
Tier
I
assessment
that
provides
a
high
end
estimate.
$
Estimated
drinking
water
concentrations
for
surface
water
are
based
on
the
FIRST
model,
which
is
a
Tier
I
assessment
that
also
provides
a
high
end
estimate.
$
The
use
of
fenarimol
on
turf
was
modeled
for
both
ground
water
and
surface
water.
The
turf
use
has
the
highest
application
rate
of
2.7
lbs
ai/
A.
The
turf
use
comprises
28%
or
approximately
17,000
lbs
of
the
total
fenarimol
use
of
61,000
lbs
applied
annually.
About
9800
lbs
are
used
on
lawns
and
about
7000
lbs
are
used
on
golf
course
turf.
$
Model
estimates
can
be
refined
when
additional
fate
data
become
available.
$
For
chronic
risk
to
surface
water,
the
EEC
of
84
ppb
is
above
the
chronic
DWLOCs
of
70
ppb
for
general
population,
60
ppb
for
females
13
50
years
old,
and
20
ppb
for
infants
and
children
1
6
years,
indicating
that
chronic
exposure
to
fenarimol
in
surface
water
may
be
of
concern
for
residential
turf
uses.
$
Removing
the
residential
turf
uses
from
the
labels
and
with
only
the
golf
course
use
remaining
would
reduce
the
chronic
surface
water
DWLOC
to
26
ppb.
$
Surface
water
modeling
for
drinking
water
uses
a
percent
cropped
area
factor
(
PCA).
The
PCA
represents
the
fraction
of
a
watershed
that
is
cropped
and
treated
with
the
pesticide
being
modeled.
In
the
absence
of
having
a
PCA
factor
for
a
particular
crop
a
default
PCA
of
0.87
is
used.
The
0.87
factor
represents
the
maximum
fraction
of
a
watershed
in
the
US
that
is
agriculturally
cropped.
Given
the
relatively
low
usage
of
fenarimol
across
the
country
it
is
highly
unlikely
that
the
amount
applied
to
the
watershed
in
the
model
will
be
concentrated
in
any
real
watershed
used
to
derive
drinking
water.
$
For
chronic
risk
to
groundwater,
the
EEC
of
16
is
below
the
chronic
DWLOCs
of
70
ppb
for
general
population,
60
ppb
for
females
13
50
years
old,
and
20
ppb
for
infants
and
children
1
6
years,
indicating
that
chronic
exposure
to
fenarimol
in
ground
water
is
not
of
6
concern.
$
Additional
data
are
being
required
that
will
provide
important
information
on
the
mobility
of
fenarimol
and
its
degradates.
These
studies
will
help
refine
the
assessment.
$
Very
limited
water
monitoring
data
are
available
for
fenarimol.
Residential
Risk
The
registrants
have
agreed
to
add
prohibitions
on
the
labels
indicating
that
fenarimol
products
are
not
for
use
or
sale
to
homeowners.
Also,
the
registrants
have
agreed
to
delete
residential
uses
from
end
use
labels
until
data
are
developed
to
further
clarify
potential
risk
to
children.
The
following
summary
is
provided
to
outline
the
rationale
for
deleting
this
use
as
an
interim
mitigation
measure.
Residential
Postapplication
Risk
$
For
the
short
term
(
1
30
day)
incidental
oral,
dermal,
and
inhalation
risk
assessments,
a
LOAEL
of
35
mg/
kg/
day
was
selected.
This
endpoint
is
based
on
decreased
fertility
and
dystocia
(
difficult
labor),
an
indicator
of
hormonal
effects,
observed
in
a
special
nonguideline
cross
breeding
reproduction/
developmental
toxicity
study
in
rats.
Because
a
LOAEL
is
used
an
additional
3x
uncertainty
factor
was
applied
in
addition
to
the
10x
interspecies,
10x
intraspecies,
and
3x
FQPA
factor.
A
Margin
of
Exposure
or
MOE,
which
is
the
ratio
of
the
NOAEL
to
the
exposure
estimate,
of
greater
than
900
does
not
exceed
the
Agency's
level
of
concern
for
these
risk
assessments.
$
Increasing
the
minimum
retreatment
interval
on
residential/
recreational
turf
from
7
to
30
days
would
eliminate
the
residential
postapplication
intermediate
term
exposure
scenarios.
This
is
based
on
chemical
specific
data
from
a
turf
transferable
residue
(
TTR)
study
which
estimates
that
the
dissipation
of
fenarimol
is
approximately
8%
per
day.
$
Only
short
term
risks
from
residential
postapplication
dermal
and
incidental
oral
exposures
are
anticipated
and
were
estimated
for
fenarimol.
No
intermediate
or
long
term
exposure
scenarios
are
anticipated
due
to
proposed
labeling
changes.
Postapplication
inhalation
exposures
are
not
anticipated
because
the
vapor
pressure
of
fenarimol
is
low
(
2.2
x
10
7
mmHg).
$
A
5%
dermal
absorption
factor
was
derived
from
a
monkey
study.
Dermal
absorption
rates
of
1.36%,
2.32%,
3.12%
and
4.12%
(
mean
2.73%
±
1.17%)
were
observed
for
the
four
individual
monkeys.
However,
from
8
to
29%
of
the
dermally
applied
radioactivity
was
not
accounted
for.
Since
there
was
variation
in
the
dermal
absorption
in
the
four
monkeys
and
there
was
radioactivity
not
accounted
for,
a
value
of
5%
is
appropriate.
$
The
scenarios
assessed
for
the
purpose
of
determining
risk
estimates
included
adults
and
7
children
performing
high
contact
play
or
work
activities
on
treated
lawns,
and
adults
mowing
lawns
or
golfing.
Small
children
(
toddlers)
were
also
assessed
for
incidental
oral
exposure
from
hand
to
mouth
activities
while
playing
on
a
treated
lawn.
Some
of
these
exposures
were
combined,
where
it
was
deemed
reasonably
likely
that
activities
would
cooccur
$
Risk
estimates
for
short
term
dermal
contact
with
treated
turf
during
high
contact
lawn
activities
(
e.
g.
playing)
on
day
zero
following
application
exceed
the
Agency's
estimated
level
of
concern,
i.
e.
result
in
MOEs
<
900
for
children
(
MOE
=
660).
Risk
estimates
for
short
term
dermal
contact
with
fenarimol
residues
on
treated
turf
on
the
day
of
treatment
do
not
exceed
the
level
of
concern
for
adults
during
the
low
contact
activities
of
grass
mowing
(
MOE
=
27,000)
or
golfing
(
MOE
=
14,000).
$
EPA
assessed
short
term
exposure
of
small
children
from
incidental
episodic
ingestion
of
fenarimol
granules
following
application
to
residential
lawns.
The
risk
calculations
indicate
that
ingestion
of
fenarimol
granules
(
MOE
=
220)
exceed
the
level
of
concern
(
MOEs
<
900).
However,
EPA
considers
the
incidental
episodic
risk
of
ingestion
of
fenarimol
granules
to
be
unlikely
given
the
small
particle
size
of
fenarimol
granules
and
the
low
percentage
of
active
ingredient
(
0.78%).
Approximately
93%
of
the
product
has
a
particle
diameter
range
of
0.594
to
0.841
mm,
with
the
remaining
7%
in
the
0.841
to
2
mm
size.
The
granules
are
white
in
color.
If
evenly
distributed,
individual
grains
would
be
difficult
to
pick
up,
or
even
to
see
when
applied
on
a
lawn.
Therefore,
this
product
would
be
difficult
for
a
small
child
to
grasp
and
then
mouth
or
ingest.
$
EPA
also
assessed
short
term
exposures
to
small
children
from
incidental
episodic
ingestion
of
residues
following
application
to
residential
lawns.
The
risk
calculations
for
small
children's
non
dietary
hand
to
mouth
activities
(
MOE
=
860)
indicate
that
risks
exceed
the
level
of
concern
(
MOEs
<
900).
Incidental
ingestion
of
soil
(
MOE
=
260,000)
and
incidental
turfgrass
mouthing
(
MOE
=
3400)
did
not
exceed
the
level
of
concern
(
MOEs
<
900).
The
small
children's
combined
oral
hand
to
mouth
scenarios
(
except
granular
ingestion)
also
exceeds
the
level
of
concern
(
MOE
=
690).
When
risk
estimates
to
small
children
from
short
term
dermal
exposures
are
combined
with
risk
estimates
from
all
incidental
oral
exposures
(
except
episodic
ingestion
of
fenarimol
granules)
the
combined
short
term
risk
estimate
exceeds
the
level
of
concern
(
MOE
=
340).
$
Chemical
specific
data
from
a
turf
transferable
residue
(
TTR)
study
were
available.
A
dissipation
rate
of
8%
daily
was
derived
from
this
data
and
translated
to
residential
application.
The
Residential
SOPs
were
utilized
to
estimate
initial
residues
(
i.
e.
DAT
0
residues)
based
on
application
rate
and
to
estimate
contact
rates
with
turf.
The
data
show
that
6.1%,
0.85%,
and
0.59%
(
for
CA,
IN
&
MS,
respectively)
of
the
applied
fenarimol
was
detected
on
DAT
0.
By
comparison,
the
Agency's
SOP
uses
a
transfer
efficiency
(
percent
of
application
rate)
of
5%.
Therefore,
due
to
the
variability
of
the
study
transfer
efficiency
data,
the
poor
quality
of
the
study
itself,
and
because
no
transfer
coefficient
exists
for
the
California
roller
method
that
was
used
in
this
study,
a
5%
transfer
efficiency
8
rate
was
used
for
risk
assessment
purposes.
Additional
TTR
data
would
allow
further
refinement
of
the
exposure
estimate.
Aggregate
Risk
(
For
a
complete
discussion,
see
section
5.0
of
the
Human
Health
Risk
Assessment)
$
The
aggregate
risk
assessment
for
fenarimol
examines
the
combined
risk
from
exposure
through
food,
drinking
water,
and
residential
exposure
where
applicable.
$
Because
an
acute
toxicity
endpoint
was
not
identified,
an
acute
aggregate
risk
assessment
is
not
required.
$
Based
on
agreements
with
the
registrant
regarding
amendments
(
i.
e.,
removal
of
residential
uses)
to
product
labels,
the
Agency
anticipates
neither
residential
handler
nor
residential
postapplication
exposure
to
children.
Consequently,
these
scenarios
were
not
included
in
an
aggregate
risks
assessment.
$
Since
the
residential
uses
are
being
removed
from
the
labels
only
the
short
term
dermal
postapplication
exposures
for
adult
golfers
was
combined
with
the
average
dietary
(
food
&
water)
exposures
in
a
short
term
aggregate
risk
assessment.
The
aggregate
risk
estimate
for
the
postapplication
short
term
dermal
exposure
scenario
of
golfing
did
not
exceed
the
Agency's
level
of
concern.
The
exposure
from
food
is
zero
for
adults;
therefore,
the
aggregate
risk
estimates
include
only
dermal
and
water
exposures.
The
short
term
DWLOCs
are
calculated
to
be
1267
ppb
for
adult
males
and
1086
ppb
for
adult
females
which
are
well
above
the
estimated
EECs
for
ground
(
16
ppb)
and
surface
water
(
26
ppb),
and
indicate
that
combined
short
term
dietary
(
food
&
water)
and
dermal
exposures
do
not
exceed
the
Agency's
level
of
concern.
$
The
EEC
for
ground
water
is
less
than
all
DWLOCs;
therefore,
there
is
no
concern
for
aggregate
chronic
exposure
to
fenarimol
and
its
degradates
from
food
and
ground
water.
$
Excluding
the
residential
use,
the
EEC
for
surface
water
(
26
ppb)
slightly
exceeds
the
DWLOC
for
children
under
6.
However,
the
estimated
EEC
for
surface
water
is
a
very
conservative
estimate.
The
surface
water
EEC
is
not
likely
to
underestimate
exposure
to
fenarimol
and
its
degradates
based
on
the
conservative
inputs
to
the
model
(
i.
e.,
default
PCA,
no
decay
via
the
major
degradation
pathway,
and
the
concentrated
application
scenario
modeled
is
unlikely
to
occur
in
a
real
watershed
where
drinking
water
is
derived).
Occupational
and
Ecological
Risk
$
Because
fenarimol
is
under
review
for
tolerance
reassessment
only,
no
occupational
or
ecological
risk
assessment
was
not
conducted.
9
Tolerance
Reassessment
Summary
(
For
a
complete
discussion,
see
Fenarimol,
Product
and
Residue
Chemistry
Chapter
for
the
Tolerance
Reassessment
Eligibility
Decision,
dated
10/
18/
2001.)
The
Agency
has
reassessed
all
42
tolerances
for
fenarimol
and
can
make
a
FQPA
safety
determination.
Table
2
Tolerance
Reassessment
Summary
For
Fenarimol.
Commodity
Established
Tolerance
(
ppm)
Reassessed
Tolerance
(
ppm)
Comment
[
Correct
Commodity
Definition]
Tolerance
Listed
Under
40
CFR
§
180.421(
a)(
1)
Apple
pomace
(
wet
and
dry)
2.0
0.3
The
available
data
indicate
that
the
tolerance
for
wet
apple
pomace
should
be
reduced.
Dry
apple
pomace
is
no
longer
considered
a
significant
livestock
feed
item.
[
Apple,
wet
pomace]
Apples
0.1
0.1
[
Apple]
Cattle,
fat
0.1
0.01
Residue
data
indicate
that
the
tolerance
should
be
reassessed
at
0.01
ppm
(
method
limit
of
quantitation
[
LOQ]).
Cattle,
meat
0.01
0.01
Residue
data
indicate
that
the
tolerance
should
be
reassessed
at
0.01
ppm
(
method
limit
of
quantitation
[
LOQ]).
Cattle,
mbyp
0.01
0.05
[
Cattle,
meat
byproducts,
except
kidney]
Residue
data
indicate
that
the
tolerance
should
be
reassessed
at
0.05
ppm.
Cattle,
kidney
0.1
0.01
Residue
data
indicate
that
the
tolerance
should
be
reassessed
at
0.01
ppm
(
method
limit
of
quantitation
[
LOQ]).
Cattle,
liver
0.1
Revoke
[
included
in
meat
byproducts]
Eggs
0.01
Revoke
There
are
no
poultry
feed
items
associated
with
presently
registered
uses.
Goat,
fat
0.1
0.01
Residue
data
indicate
that
the
tolerance
should
be
reassessed
at
0.01
ppm
(
method
limit
of
quantitation
[
LOQ]).
Goat,
meat
0.01
0.01
Residue
data
indicate
that
the
tolerance
should
be
reassessed
at
0.01
ppm
(
method
limit
of
quantitation
[
LOQ]).
Goat,
mbyp
0.01
0.05
[
Goat,
meat
byproducts,
except
kidney]
Residue
data
indicate
that
the
tolerance
should
be
reassessed
at
0.05
ppm.
Goat,
kidney
0.1
0.01
Residue
data
indicate
that
the
tolerance
should
be
reassessed
at
0.01
ppm
(
method
limit
of
quantitation
[
LOQ]).
Goat,
liver
0.1
Revoke
[
included
in
meat
byproducts]
Hog,
fat
0.1
Revoke
There
are
no
hog
feed
items
associated
with
presently
registered
uses.
Hog,
meat
0.01
Revoke
Hog,
mbyp
0.01
Revoke
Hog,
kidney
0.1
Revoke
Commodity
Established
Tolerance
(
ppm)
Reassessed
Tolerance
(
ppm)
Comment
[
Correct
Commodity
Definition]
10
Hog,
liver
0.1
Revoke
Horse,
fat
0.1
0.01
Residue
data
indicate
that
the
tolerance
should
be
reassessed
at
0.01
ppm
(
method
limit
of
quantitation
[
LOQ]).
Horse,
meat
0.01
0.01
Residue
data
indicate
that
the
tolerance
should
be
reassessed
at
0.01
ppm
(
method
limit
of
quantitation
[
LOQ]).
Horse,
mbyp
0.01
0.05
[
Horse,
meat
byproducts,
except
kidney]
Residue
data
indicate
that
the
tolerance
should
be
reassessed
at
0.05
ppm.
Horse,
liver
0.1
Revoke
[
included
in
meat
byproducts]
Horse,
kidney
0.1
0.01
Residue
data
indicate
that
the
tolerance
should
be
reassessed
at
0.01
ppm
(
method
limit
of
quantitation
[
LOQ]).
Milk
0.003
Revoke
Category
3
of
40
CFR
§
180.6(
a)
Pears
0.1
0.1
[
Pear]
Pecans
0.1
0.02
[
Pecan]
Residue
data
have
been
submitted
to
reassess
the
established
tolerance
for
pecans.
Poultry,
fat
0.01
Revoke
There
are
no
poultry
feed
items
associated
with
presently
registered
uses.
Poultry,
meat
0.01
Revoke
Poultry,
mbyp
0.01
Revoke
Sheep,
fat
0.1
0.01
Residue
data
indicate
that
the
tolerance
should
be
reassessed
at
0.01
ppm
(
method
limit
of
quantitation
[
LOQ]).
Sheep,
meat
0.01
0.01
Residue
data
indicate
that
the
tolerance
should
be
reassessed
at
0.01
ppm
(
method
limit
of
quantitation
[
LOQ]).
Sheep,
mbyp
0.01
0.05
[
Sheep,
meat
byproducts,
except
kidney]
Residue
data
indicate
that
the
tolerance
should
be
reassessed
at
0.05
ppm.
Sheep,
kidney
0.1
0.01
Residue
data
indicate
that
the
tolerance
should
be
reassessed
at
0.01
ppm
(
method
limit
of
quantitation
[
LOQ]).
Sheep,
liver
0.1
Revoke
[
included
in
meat
byproducts]
Tolerance
Listed
Under
40
CFR
§
180.421(
a)(
2)
Bananas
1
0.5
(
Not
more
than
0.25
ppm
shall
be
present
in
the
pulp
after
peel
is
removed)
0.25
[
Banana]
Residue
data
have
been
submitted
to
reassess
the
established
tolerance
for
bananas.
Cherries
1.0
1.0
[
Cherry]
Grape
juice
0.6
Revoke
Not
required
based
on
reexamination
of
available
grape
processing
data.
Commodity
Established
Tolerance
(
ppm)
Reassessed
Tolerance
(
ppm)
Comment
[
Correct
Commodity
Definition]
11
Grape
pomace
(
wet
and
dry)
2.0
Revoke
No
longer
considered
a
significant
livestock
feed
item.
Grapes
0.2
0.1
[
Grape]
Residue
data
have
been
submitted
to
reassess
the
established
tolerance
for
grapes.
Raisin
waste
3.0
Revoke
No
longer
considered
a
significant
livestock
feed
item.
Raisins
0.6
Revoke
Not
required
based
on
reexamination
of
available
grape
processing
data.
Tolerance
to
be
Established
Under
40
CFR
§
180.421(
a)(
1)
Filberts
not
applicable
0.02
Residue
chemistry
data
support
the
establishment
of
a
0.02
ppm
tolerance
for
filberts.
1
For
tolerance
reassessment
purposes,
the
banana
tolerance
is
counted
as
two
tolerances
to
reflect
the
baseline
count
determined
at
the
start
of
FQPA
(
bananas
and
bananas,
pulp).
Codex/
International
Harmonization
The
Codex
Alimentarius
Commission
has
established
several
maximum
residue
limits
(
MRLs)
for
residues
of
fenarimol
in/
on
various
raw
agricultural
and
processed
commodities.
The
Codex
MRLs
are
expressed
in
terms
of
fenarimol
per
se.
A
numerical
comparison
of
the
Codex
MRLs
and
the
corresponding
reassessed
U.
S.
tolerances
is
presented
in
the
Table
below.
The
Table
shows
that
except
for
cattle
liver,
cherries,
and
pecans,
the
U.
S.
tolerances
and
Codex
MRLs
are
not
in
harmony
with
respect
to
numerical
levels.
Table
3
Codex
MRLs
and
applicable
U.
S.
tolerances
for
fenarimol.
Recommendations
are
based
on
conclusions
following
reassessment
of
U.
S.
tolerances.
Codex
Reassessed
U.
S.
Tolerance,
ppm
Recommendation
And
Comments
Commodity,
As
Defined
MRL
1
(
mg/
kg)
Apple
pomace,
dry
5
wet
apple
pomace
=
0.3
Dry
apple
pomace
is
no
longer
considered
a
significant
livestock
feed
item.
Artichoke
globe
0.1
Banana
0.2
0.25
Cattle
kidney
0.02
(*)
0.01
(*)
Cattle
liver
0.05
Revoke
covered
by
tolerance
for
meat
byproducts
Cattle
meat
0.02
(*)
0.01
(*)
Cherries
1
1
Dried
grapes
(
currants,
raisins
and
sultanas)
0.2
Revoke
Codex
Reassessed
U.
S.
Tolerance,
ppm
Recommendation
And
Comments
Commodity,
As
Defined
MRL
1
(
mg/
kg)
12
Grapes
0.3
0.1
Hops,
dry
5
Melons,
except
watermelon
0.05
Peach
0.5
Pecan
0.02
(*)
0.02
(*)
Peppers,
sweet
0.5
Pome
fruits
0.3
apple/
pear
=
0.1
Strawberry
1
1
All
MRLs
are
at
CXL
step.
An
asterisk
(*)
signifies
that
the
MRL
or
US
tolerance
was
established
at
or
about
the
limit
of
detection.
Fenarimol
Data
Gaps
The
following
confirmatory
data
requirements
have
been
initially
identified
by
the
Agency:
Environmental
Fate
Data:
835.1230
Sediment
and
Soil
Adsorption/
Desorption
for
parent
and
degradates
835.2240
Direct
Photolysis
Rate
of
Parent
and
Degradates
in
Water
835.2410
Photodegradation
of
Parent
and
Degradates
in
Soil
835.4300
Aerobic
Aquatic
Metabolism
for
parent
and
degradates
835.4400
Anaerobic
Aquatic
Metabolism
for
parent
and
degradates
835.6100
Terrestrial
Field
Dissipation
Product
and
Residue
Chemistry
Data:
Additional
data
are
required
concerning
enforcement
analytical
methods,
stability,
storage
stability,
pH,
UV/
Visible
absorption,
density,
octanol/
water
partition
coefficient,
and
solubility
(
OPPTS
830.1800,
6313,
6317,
7000,
7050,
7300,
7550,
and
7840)
of
the
T/
TGAI.
Storage
stability
data
for
livestock
commodities
are
required
to
support
the
storage
intervals
used
in
the
livestock
feeding
studies.
Toxicology
Data:
870.2500
Primary
Dermal
Irritation
Study
13
870.3465
28
Day
Subchronic
Inhalation
Study
870.6300
Special
Developmental
Toxicity
Study
in
Rats
| epa | 2024-06-07T20:31:43.728460 | regulations | {
"license": "Public Domain",
"url": "https://downloads.regulations.gov/EPA-HQ-OPP-2002-0250-0004/content.txt"
} |
EPA-HQ-OPP-2002-0250-0005 | Supporting & Related Material | "2002-09-24T04:00:00" | null | UNITED
STATES
ENVIRONMENTAL
PROTECTION
AGENCY
WASHINGTON,
D.
C.
20460
OFFICE
OF
PREVENTION,
PESTICIDES
AND
TOXIC
SUBSTANCES
September
3,
2002
MEMORANDUM
SUBJECT:
Fenarimol.
Updated
HED
Human
Health
Assessment
for
the
Tolerance
Reassessment
Eligibility
Decision
(
TRED)
Document.
Chemical
No.
206600.
No
MRID
#.
DP
Barcode
No.
D285162.
FROM:
Barry
O'Keefe,
Residential
Exposure
Assessor/
Risk
Assessor
John
Doherty,
Toxicologist
Danette
Drew,
Chemist
Reregistration
Branch
3
Health
Effects
Division
(
7509C)
THRU:
Catherine
Eiden,
Branch
Senior
Scientist
Reregistration
Branch
3
Health
Effects
Division
(
7509C)
TO:
Tom
Myers,
Chemical
Review
Manager
Special
Review
and
Reregistration
Division
(
7508C)
This
memorandum
and
attachments
are
the
Amended
&
Revised
Health
Effects
Division's
Tolerance
Reassessment
Eligibility
Decision
(
TRED)
Document
for
fenarimol,
taking
into
consideration
comments
and
additional
information
on
the
aquatic
photodegradates
recieved
from
the
registrant,
Gowan
Company,
and
requirements
of
the
1996
Food
Quality
Protection
Act
(
FQPA).
This
additional
information
prompted
the
Environmental
Fate
and
Effects
Division
(
EFED)
to
reassess
the
drinking
water
exposure
for
fenarimol.
The
updated
drinking
water
assessment
(
July
31,
2002;
D284487)
was
revised
to
include
fenarimol
and
its
aquatic
photodegradates.
The
model
inputs
were
adjusted
so
that
aquatic
concentrations
were
estimated
assuming
no
aqueous
photolysis,
which
appears
to
be
fenarimol's
most
significant
route
of
dissipation
in
the
environment.
The
result
provided
a
screening
level
estimate
of
combined
concentrations
of
fenarimol
and
its
aquatic
degradates
that
is
conservative
and
that
does
not
underestimate
exposure.
Although,
there
is
still
some
uncertainty
as
to
the
identity,
fate,
and
behavior
of
the
photolysis
degradates
of
fenarimol,
data
will
be
required
to
address
this
uncertainty.
Subsequently,
the
HED
FQPA
Safety
Factor
Committee
(
SFC)
met
to
reevaluate
fenarimol.
Based
on
the
updated
drinking
water
assessment
and
the
recent
HIARC
conclusions
regarding
aromatase,
the
FQPA
SFC
recommended
that
the
FQPA
safety
factor
for
fenarimol
be
reduced
from
10x
to
3x.
2
Additionally,
HED
has
been
informed
by
SRRD
that
the
registrant
has
agreed
to
amend
their
product
labels
to
prohibit
residential
use
and
handling
(
i.
e.
mixing,
loading
or
applying)
of
fenarimol
in
residential
settings.
Applications
to
turf
will
be
limited
to
golf
courses,
and
stadium
fields
or
professional
athletic
fields
only.
Additionally,
the
minimum
re
application
interval
to
turf
will
be
increased
to
30
days.
Therefore,
residential
handler
and
residential
postapplication
exposure
scenarios
should
no
longer
exist.
The
only
non
occupational
postapplication
exposure
scenario
remaining
to
evaluate
is
short
term
dermal
exposure
to
adult
golfers.
Applications
to
residential
turf
will
not
be
permitted
by
product
labels
until
such
time
as
additional
toxicity
data
are
submitted
and
reviewed.
Then
the
Agency
will
reevaluate
the
risk
assessment
for
residential
uses.
This
assessment
only
discusses
the
human
health
risks
required
for
reassessment
of
tolerances
and
does
not
include
an
occupational
risk
assessment
required
for
reregistration
of
products.
Fenarimol
was
registered
after
1984,
so
it
is
not
subject
to
reregistration
under
FIFRA
88.
However,
fenarimol
is
subject
to
tolerance
reassessment
under
the
FQPA.
When
fenarimol
undergoes
product
reregistration,
SRRD
should
insure
that
all
product
labels
are
in
compliance
with
the
worker
protection
standard
(
WPS).
Cumulative
risk
assessment
considering
risks
from
other
pesticides
which
may
have
a
common
mechanism
of
toxicity
is
also
not
addressed
in
this
document.
Attachments:
Fenarimol
2nd
Report
of
the
FQPA
Safety
Factor
Committee
(
B.
Tarplee,
8/
13/
01)
Third
Report
of
the
Hazard
Identification
Assessment
Review
Committee
(
J.
Doherty,
7/
29/
02)
Updated
Drinking
Water
Assessment
to
Support
TRED
for
Fenarimol
(
N.
Birchfield,
7/
31/
02)
Fenarimol.
Amendment
to
Revised
HED
Human
Health
Assessment
for
the
Tolerance
Reassessment
Eligibility
Decision
(
TRED)
Document
(
B.
O'Keefe,
8/
1/
02)
Hazard
Identification
Assessment
Review
Committee
Report
(
J.
Doherty,
9/
5/
01)
FQPA
Committee
Report
(
B.
Tarplee,
9/
28/
01)
Mechanism
of
Toxicity
Committee
(
METARC)
report
(
J.
Doherty,
9/
17/
01),
Toxicology
Chapter
(
J.
Doherty,
D275392,
10/
12/
01)
Chemistry
Chapter
(
D.
Drew,
D277505,
10/
18/
01)
Dietary
Exposure
Analysis
(
D.
Drew,
D278898,
11/
19/
01)
Metabolism
Assessment
Review
Committee
report
(
D.
Drew,
D277692,
9/
17/
01)
Residential
Exposure
Analysis
(
B.
O'Keefe,
D280935,
2/
12/
02)
Drinking
Water
Assessment
to
Support
the
TRED
for
Fenarimol
(
L.
Libelo,
8/
6/
01).
1.0
EXECUTIVE
SUMMARY
Fenarimol
is
a
member
of
the
pyrimidine
class
of
fungicides,
which
also
includes
dimethirimol,
bupirimate,
and
ethirimol.
It
is
the
only
member
of
this
class
registered
for
use
in
the
U.
S.
Fenarimol
is
a
localized
systemic
foliar
fungicide
used
for
control
of
such
pests
as
scab,
powdery
mildew,
rusts,
and
leaf
spot.
Fenarimol
inhibits
fungal
growth
by
adversely
affecting
the
formation
of
the
fungal
sterol
ergosterol.
The
chemical
name
of
fenarimol
is
alpha(
2
chlorophenyl)
alpha(
4
chlorophenyl)
5
pyrimidinemethanol.
3
Use
Profile
Fenarimol
is
currently
registered
for
use
on
the
following
fruit
and
nut
crops:
apples,
cherries,
filberts,
grapes,
pears,
bananas
and
pecans.
It
is
also
registered
for
use
on
ornamental
plants,
trees,
grasses,
and
turf.
The
registration
of
fenarimol
is
being
supported
by
Gowan
Company.
Fenarimol
total
domestic
usage
for
years
1990
1999
averaged
approximately
61,000
pounds
active
ingredient.
Its
largest
markets,
in
terms
of
total
pounds
active
ingredient
(
ai),
are
allocated
to
apples
(
33%),
outdoor
nurseries
(
20%),
turf
for
lawns
(
16%),
and
turf
for
golf
courses
(
12%).
The
remaining
usage
is
primarily
on
raisin
and
wine
grapes,
cherries,
filberts,
and
pears.
Crops
with
a
high
percentage
of
the
total
U.
S.
planted
acres
treated
include
apples
(
25%),
raisin
grapes
(
21%),
sweet
cherries
(
13%),
tart
cherries,
wine
grapes,
and
filberts
(
9%
each),
and
table
grapes
(
8%).
Fenarimol
formulations
include
granular
(
0.78%
ai,
turf
use
only),
soluble
concentrate/
liquid
(
11.6%
ai),
flowable
concentrate
(
2.4%
ai)
and
emulsifiable
concentrates
(
11.6%
ai
and
12%
ai).
Only
applications
to
lawns
and
turf
are
expected
to
result
in
residential
exposures.
Although
some
end
use
products
have
label
restrictions
and
wording
indicative
of
non
homeowner
use,
fenarimol
is
not
a
restricted
use
pesticide
and
can
be
purchased
and
applied
by
anyone.
Only
the
granular
formulation
is
assumed
to
be
applied
by
residents.
However,
HED
has
been
informed
by
SRRD
that
the
registrants
of
fenarimol
have
agreed
to
amend
their
product
labels
to
prohibit
residential
use
and
handling
(
i.
e.
mixing,
loading
or
applying)
of
fenarimol
in
residential
settings.
Applications
to
turf
will
be
limited
to
golf
courses,
and
stadium
fields
or
professional
athletic
fields
only.
Hazard
Identification
and
Dose
Response
Assessment
The
toxicity
database
for
fenarimol
is
substantially
complete,
with
the
following
data
gaps
identified:
Primary
Dermal
Irritation
Study
(
870.2400);
28
Day
Subchronic
Inhalation
Study
(
870.3465);
and
Special
Developmental
Study
(
870.6300).
Fenarimol
has
moderate
acute
toxicity
via
the
oral,
dermal
or
inhalation
routes
(
all
Category
III).
Fenarimol
causes
corneal
opacity
in
rabbit
eyes
(
Category
II).
There
are
no
data
on
dermal
irritation.
Fenarimol
was
not
shown
to
be
a
contact
dermal
sensitizer
in
the
guinea
pig.
The
rat
metabolism
study
indicates
that
following
oral
administration,
fenarimol
is
rapidly
absorbed
and
excreted,
with
the
biliary
route
being
the
major
route
of
excretion.
Subchronic
oral
dosing
in
rats
demonstrates
very
little
toxicity
except
for
some
slight
body
weight
changes
and
liver
pathology
of
low
degree
and
consistency
(
liver
weight
increase
and
fatty
liver).
In
dogs,
there
was
little
overt
toxicity.
Dermal
absorption
was
estimated
by
HIARC
(
9/
6/
01)
to
be
20%
based
on
a
weight
of
the
evidence
assessment
using
rabbit
and
monkey
dermal
absorption
studies
along
with
a
comparison
of
the
rabbit
oral
developmental
toxicity
and
rabbit
21
day
dermal
toxicity
studies.
However,
based
on
additional
data
supplied
by
the
registrant
(
Gowan
Company),
the
HIARC
(
5/
23/
02)
determined
that
a
dermal
absorption
rate
estimate
of
5%
was
more
appropriate
for
risk
assessment
purposes.
The
liver
is
the
most
evident
target
organ
for
chronic
toxicity,
aside
from
the
effects
of
fenarimol
on
aromatase.
Liver
toxicity
was
manifested
by
liver
weight
increases
and
the
presence
of
"
fatty
liver"
in
rats.
In
dogs,
liver
weight
was
increased
and
there
were
also
increases
in
serum
enzymes
indicative
of
liver
toxicity.
The
data
base
for
carcinogenicity
is
considered
complete.
Fenarimol
has
been
4
classified
as
a
"
not
likely"
human
carcinogen
(
Group
E).
The
mutagenicity/
genetic
toxicity
data
base
is
considered
complete
and
indicates
no
mutagenicity
concern.
The
data
base
for
prenatal
developmental
and
reproductive
toxicity
is
considered
complete.
The
developmental
and
reproductive
toxicity
studies
showed
no
evidence
of
increased
sensitivity
or
susceptibility
of
young
rats
or
rabbits
following
pre
or
postnatal
exposure
to
fenarimol.
The
studies
demonstrated
that
fenarimol
is
associated
with
hydronephrosis
that
is
reversible.
The
most
prominent
aspect
of
fenarimol
toxicity
was
evident
in
the
rat
multi
generation
reproduction
studies
and
relates
to
inhibition
of
aromatase.
Aromatase,
also
known
as
estrogen
synthetase,
is
the
key
enzyme
for
the
conversion
of
androgens
to
estrogens
and
is
therefore
a
potentially
critical
enzyme
in
maintaining
hormone
balance
in
human
physiology.
Without
aromatase,
there
could
potentially
be
deficits
in
estrogens
which
are
important
for
a
variety
of
physiological
functions.
Estrogens
are
largely
responsible
for
the
changes
that
take
place
during
puberty
in
human
females
and
affect
secondary
sexual
characteristics.
It
is
also
recognized
that
aromatase
deficient
males
do
not
develop
normal
skeletal
characteristics.
The
Mechanism
of
Toxicity
Assessment
Review
Committee
(
METARC)
met
to
evaluate
the
data
concerning
fenarimol's
effects
on
aromatase
and
their
decision
memorandum
contains
a
more
detailed
discussion
of
aromatase
(
J.
Doherty,
9/
16/
01).
The
multi
generation
reproduction
studies
indicate
that
fenarimol
causes
reduced
fertility
and
dystocia
(
difficult
labor).
Separate
cross
dosing
studies
(
dosing
males
and
mating
with
untreated
females
and
dosing
females
and
mating
with
untreated
males)
indicated
that
the
reduced
fertility
is
due
to
an
effect
in
males
and
the
dystocia
is
an
effect
in
females.
These
effects
of
fenarimol
were
demonstrated
to
be
attributed
to
inhibition
of
aromatase
in
adult
animals.
The
decrease
in
fertility
in
males
results
from
the
decreased
conversion
of
testosterone
(
an
androgen)
to
estradiol
which
is
essential
for
male
sexual
development.
The
increase
in
dystocia
in
rats
was
also
attributed
to
inhibition
of
aromatase
because
in
the
rat,
progesterone
is
converted
to
estrogen
by
aromatase
to
facilitate
parturition
(
birth).
The
FQPA
required
the
Agency
to
consider
potential
special
sensitivity
to
infants
and
children
from
exposure
to
fenarimol.
Submitted
toxicity
studies
showed
that
there
is
no
increased
sensitivity
or
susceptibility
to
infants
and
children
based
mainly
on
the
results
of
the
developmental/
reproductive
toxicity
studies.
However,
a
special
developmental
study
is
required
to
determine
if
the
potential
hormonal
effects
as
elicited
by
inhibition
of
aromatase
will
result
in
effects
in
offspring.
Additionally,
the
environmental
fate
database
is
incomplete
for
the
aquatic
photolytic
degradate
of
fenarimol,
4
chloro
2(
5
pyrimidyl)
2'
chlorobenzophenone.
Previously,
the
Environmental
Fate
and
Effects
Division
(
EFED)
determined
that
a
screening
level
drinking
water
assessment,
including
this
degradate
of
potential
toxicological
concern,
was
not
possible
at
that
time.
Therefore,
based
on
residual
uncertainties
regarding
the
toxicology
database
and
exposure
considerations,
the
FQPA
committee
determined
that
the
10x
FQPA
factor
should
be
retained
for
all
fenarimol
risk
assessments.
However,
EFED
has
recently
received
additional
information
on
this
aquatic
photo
degradate
of
concern,
and
subsequently
revised
the
drinking
water
assessment
for
fenarimol.
The
updated
drinking
water
assessment
(
July
31,
2002;
D284487)
was
revised
to
include
fenarimol
and
its
aquatic
photodegradates.
The
model
inputs
were
adjusted
so
that
aquatic
concentrations
were
estimated
assuming
no
aqueous
photolysis,
which
appears
to
be
fenarimol's
most
significant
route
of
dissipation
in
the
environment.
The
result
provides
a
screening
level
estimate
of
combined
concentrations
of
fenarimol
and
its
aquatic
degradates
that
is
conservative
and
that
does
not
underestimate
exposure.
5
As
a
result
of
this
reassessment
the
chronic
EECs
increased
from
59
to
84
g/
L
for
surface
water,
and
from
14
to
16
g/
L
for
ground
water.
Although,
there
is
still
some
uncertainty
as
to
the
identity,
fate,
and
behavior
of
the
photolysis
degradates
of
fenarimol,
data
will
be
required
to
address
this
uncertainty.
Therefore,
the
FQPA
Safety
Factor
Committee
met
on
July
29,
2002,
to
reevaluate
fenarimol.
The
committee
also
reassessed
the
uncertainty
surrounding
the
potential
effects
elicited
by
inhibition
of
aromatase
by
fenarimol.
The
FQPA
SFC
agreed
with
the
HIARC
conclusion
that
a
special
developmental
toxicity
study
to
assess
for
hormonal
effects
is
required
for
fenarimol,
and
a
database
uncertainty
factor
of
3x
is
required
until
the
data
are
received
and
reviewed.
Based
on
the
updated
drinking
water
assessment
and
the
recent
HIARC
conclusions
regarding
aromatase,
the
FQPA
SFC
recommended
that
the
FQPA
safety
factor
for
fenarimol
be
reduced
from
10x
to
3x.
The
METARC
recommended,
and
the
HIARC
confirmed,
that
the
reduced
male
fertility
and
dystocia
effects
of
fenarimol
should
be
endpoints
for
human
health
risk
assessment.
It
is
noted
that
the
endpoint
from
the
multi
generation
reproduction
study
is
based
on
decreased
litter
size.
This
decrease
in
litter
size
may
be
a
reflection
of
the
maternal
toxicity
(
dystocia)
or
the
potential
for
fenarimol
to
inhibit
aromatase
in
males
(
reduced
fertility).
Because
both
males
and
females
are
affected,
the
toxicological
endpoint
from
the
multi
generation
reproduction
study
is
applicable
to
all
populations.
After
examining
all
of
the
available
toxicity
data,
the
HIARC
concluded
that
an
acute
toxicity
endpoint
and
dose
for
risk
assessment
could
not
be
identified.
That
is,
no
appropriate
endpoint
was
available
to
quantitate
risk
to
the
general
population
or
females
13
50
years
old
from
a
single
dose
administration
of
fenarimol.
Although
hydronephrosis
seen
in
the
rat
developmental
and
multigeneration
reproductive
toxicity
studies
had
been
identified
as
an
acute
adverse
toxic
effect
(
endpoint)
in
earlier
fenarimol
risk
assessments,
the
HIARC
concluded
that
it
is
not
appropriate
because:
1)
the
hydronephrosis
is
not
severe
(
its
is
considered
an
effect
of
low
degree
or
magnitude);
2)
the
hydronephrosis
was
shown
to
be
reversible;
3)
the
hydronephrosis
developed
after
multiple
exposures
and
there
is
no
indication
that
it
would
develop
following
a
single
exposure;
and,
4)
the
hydronephrosis
may
be
related
to
a
developmental
delay
and
not
a
target
specific
effect
of
fenarimol.
For
risks
associated
with
chronic
dietary
exposures,
the
HIARC
identified
a
reference
dose
for
chronic
exposure
(
cRfD)
of
0.006
mg/
kg/
day
from
the
multi
generation
reproduction
study
based
on
a
no
observed
adverse
effect
level
(
NOAEL)
of
0.6
mg/
kg/
day,
and
a
10X
uncertainty
factor
for
interspecies
extrapolation
and
a
10X
uncertainty
factor
for
intraspecies
variation.
The
NOAEL
of
0.6
mg/
kg/
day
is
based
on
decreased
live
born
litter
size
in
the
F
1
and
F
2
generations
at
a
lowest
observed
adverse
effect
level
(
LOAEL)
of
1.2
mg/
kg/
day.
HED
calculated
a
chronic
Population
Adjusted
Dose
(
cPAD)
of
0.002
mg/
kg/
day.
The
cPAD
is
the
RfD
divided
by
the
FQPA
safety
factor
(
3X).
Chronic
dietary
exposure
estimates
greater
than
100%
of
the
cPAD
would
exceed
HED's
level
of
concern.
For
risks
associated
with
intermediate
term
residential
exposures
(
1
6
months),
the
same
endpoint
(
NOAEL
of
0.6
mg/
kg/
day)
was
used
for
incidental
oral,
dermal,
and
inhalation
risk
assessments.
A
Margin
of
Exposure
or
MOE,
which
is
the
ratio
of
the
NOAEL
to
the
exposure
estimate,
of
greater
than
or
equal
to
300
does
not
exceed
HED's
level
of
concern
for
intermediate
term
risk
assessments.
A
MOE
of
greater
than
or
equal
to
300
is
required
for
these
intermediate
term
exposure
scenarios
because
of
the
10x
interspecies
factor,
the
10x
intraspecies
factor
and
the
10x
3X
FQPA
factor.
Because
the
same
endpoint
was
used
for
all
intermediate
term
exposure
assessments,
the
risk
6
estimates
for
the
various
routes
of
exposure
may
be
aggregated.
For
the
short
term
(
1
30
day)
incidental
oral,
dermal,
and
inhalation
risk
assessments,
a
LOAEL
of
35
mg/
kg/
day
was
selected.
This
endpoint
is
based
on
decreased
fertility
and
dystocia,
an
indicator
of
hormonal
effects,
observed
in
a
special
non
guideline
cross
breeding
reproduction/
developmental
toxicity
study
in
rats.
Because
a
NOAEL
could
not
be
identified
in
the
study,
and
effects
were
seen
at
the
lowest
dose
tested,
a
LOAEL
was
used,
and
an
additional
3x
uncertainty
factor
was
applied.
Therefore,
a
MOE
greater
than
900
does
not
exceed
HED's
level
of
concern
for
short
term
risk
assessments.
Because
the
same
endpoint
was
used
for
all
short
term
exposure
assessments,
the
risk
estimates
for
the
various
routes
of
exposure
may
be
aggregated.
Exposure
and
Risk
Assessment
Dietary
Exposure
and
Risk
Estimates
The
residue
chemistry
database
for
fenarimol
is
substantially
complete
and
is
adequate
for
tolerance
reassessment.
The
Metabolism
Assessment
Review
Committee
(
MARC)
has
determined
that
for
enforcement
purposes,
the
tolerance
for
plant
commodities
should
be
expressed
as
parent
only.
However
the
dietary
assessment
for
grapes
and
bananas
should
include
the
metabolites
[
alpha(
2
chlorophenyl)
alpha(
4
chlorophenyl)
1,4
dihydro
5
pyrimidinemethanol]
and
(
5[
2
chlorophenyl)
(
4
chlorophenyl)
methyl]
3,4
dihydro
4
pyrimidinol]),
because
of
their
structural
similarity
to
fenarimol.
The
residue
of
concern
in
livestock
commodities
is
fenarimol
per
se.
Tolerances
for
fenarimol
are
generally
low,
ranging
from
0.01
to
1.0
ppm
Because
an
acute
toxicity
endpoint
was
not
identified,
an
acute
dietary
exposure
assessment
was
neither
required
nor
conducted.
The
chronic
dietary
exposure
assessment
for
fenarimol
is
highly
refined
using
anticipated
residues
based
on
Food
and
Drug
Administration
(
FDA)
monitoring
data
for
apples,
bananas,
cherries,
grapes
and
pears.
There
were
no
USDA
Pesticide
Data
Program
(
PDP)
monitoring
data
available
for
fenarimol.
The
FDA
monitoring
data
indicated
no
detectable
residues
for
apples,
bananas,
grapes
and
pears.
Field
trial
residue
data
were
used
for
pecans
and
filberts.
Percent
crop
treated
(%
CT)
information
and
processing
factors,
where
available,
were
used
in
the
assessment.
Anticipated
residues
were
calculated
for
cattle
meat,
fat,
and
meat
by
products.
Wet
apple
pomace
is
the
only
animal
feed
item
associated
with
the
registered
uses
of
fenarimol.
There
are
no
poultry
or
hog
feedstuffs.
Milk
was
classified
as
Category
3
of
40
CFR
180.6(
a)
that
is,
there
is
no
reasonable
expectation
of
finite
residues.
Chronic
dietary
risk
estimates
are
provided
for
the
general
U.
S.
population
and
various
population
subgroups.
This
assessment
concludes
that
for
all
supported
registered
commodities,
the
chronic
risk
estimates
are
below
the
HED's
level
of
concern
(<
100%
of
the
chronic
population
adjusted
dose,
cPAD)
for
the
general
U.
S.
population
and
all
population
subgroups.
Dietary
(
food)
exposure
estimates
were
all
very
low
(
all
<
1%
of
the
cPAD).
This
is
not
surprising
based
on:
the
lack
of
detectable
residues
for
many
commodities
in
the
FDA
monitoring
data;
no
residues
expected
in
milk,
poultry
and
hogs;
and,
low
anticipated
residues
for
cattle
meat,
fat,
and
meat
by
products.
Environmental
fate
data
show
that
fenarimol
is
persistent
and
mobile
in
the
environment.
In
field
studies,
fenarimol
dissipated
with
half
lives
of
3
months
to
several
years
from
soil
and
turf
surfaces.
Fenarimol
is
stable
to
hydrolysis,
anaerobic
microbial
degradation
and
photolysis
on
soil.
It
is
degraded
very
slowly,
if
at
all,
by
aerobic
microbial
processes
with
reported
mean
aerobic
soil
7
metabolism
half
life
of
about
4
years.
It
is
degraded
by
photolysis
in
aqueous
solution.
The
primary
photolysis
product
was
4
chloro
2(
5
pyrimidyl)
2'
clorobenzophenone.
The
MARC
elected
not
to
exclude
this
degradate
in
the
drinking
water
exposure
assessment
because:
1)
its
potential
to
occur
in
surface
water;
and
2)
the
lack
of
data
to
determine
whether
it
is
of
toxicological
concern.
The
environmental
fate
studies
were
conducted
in
the
1970s
and
early
1980s.
The
quality
of
the
data
provided
by
these
studies
is
significantly
lower
then
currently
required.
By
current
standards
most
of
these
studies
would
not
be
considered
acceptable
and
the
results
would
not
be
considered
of
sufficient
quality
to
allow
a
reasonably
accurate
assessment
of
the
environmental
fate
of
this
compound.
Therefore,
the
estimated
environmental
concentrations
(
EECs)
presented
here
are
somewhat
uncertain,
and
may
change
substantially
when
better
data
become
available.
It
is
not
possible,
using
the
existing
data,
to
provide
a
more
refined
assessment.
To
estimate
risks
from
exposure
to
fenarimol
residues
potentially
present
in
drinking
water,
HED
has
compared
EECs
for
fenarimol
in
surface
water
and
ground
water
to
calculated
drinking
water
levels
of
comparison
(
DWLOCs).
The
DWLOC
chronic
is
the
concentration
in
drinking
water
as
a
part
of
the
aggregate
chronic
exposure
that
occupies
no
more
than
100%
of
the
cPAD
when
considered
together
with
other
sources
of
exposure.
If
the
EECs
are
greater
than
the
DWLOCs,
there
is
a
potential
drinking
water
concern.
Screening
level
assessments,
using
conservative
modeling
to
estimate
highend
average
concentrations
(
EECs)
of
fenarimol
in
surface
water
and
ground
water,
were
conducted
by
the
Environmental
Fate
and
Effects
Division
(
EFED).
Tier
I
modeling
was
performed
for
both
surface
water
(
FIRST
model)
and
groundwater
(
SCI
GROW
model).
EFED
modeled
the
turf
application
use
scenario
in
both
cases.
A
Tier
II
model
is
not
available
for
turf.
Initially,
the
drinking
water
assessment
did
not
include
the
water
degradate
of
concern,
because
the
environmental
fate
database
is
incomplete
for
the
aquatic
photo
degradate
of
fenarimol,
4
chloro
2
(
5
pyrimidyl)
2'
chlorobenzophenone.
Consequently,
there
was
some
residual
uncertainty
thatthe
drinking
water
assessment
may
underestimate
exposure.
However,
recently,
the
Environmental
Fate
and
Effects
Division
(
EFED)
received
additional
information
on
the
aquatic
photo
degradate
and
revised
the
drinking
water
assessment.
The
updated
drinking
water
assessment
(
July
31,
2002;
D284487)
includes
fenarimol
and
its
aquatic
photodegradates.
The
model
inputs
were
adjusted
so
that
aquatic
concentrations
were
estimated
assuming
no
aqueous
photolysis,
which
appears
to
be
fenarimol's
most
significant
route
of
dissipation
in
the
environment.
Minor
model
input
corrections
were
also
made
to
the
application
rate
and
interval.
The
result
provides
a
screening
level
estimate
of
combined
concentrations
of
fenarimol
and
its
aquatic
degradates
that
is
conservative
and
that
does
not
underestimate
exposure.
As
a
result
of
this
reassessment
the
chronic
EECs
increased
from
59
to
84
g/
L
for
surface
water,
and
from
14
to
16
g/
L
for
ground
water.
Although,
there
is
still
some
uncertainty
as
to
the
identity,
fate,
and
behavior
of
the
photolysis
degradates
of
fenarimol,
data
will
be
required
to
address
this
uncertainty.
The
EEC
for
ground
water
is
less
than
all
DWLOCs;
therefore,
there
is
no
concern
for
aggregate
chronic
exposure
to
fenarimol
and
its
degradates
from
food
and
ground
water.
The
EEC
for
surface
water
is
greater
than
all
DWLOCs;
therefore,
there
is
a
potential
concern
for
aggregate
chronic
exposures
to
fenarimol
from
food
and
surface
water.
However,
the
estimated
EEC
for
surface
water
is
a
very
conservative
estimate.
It
represents
the
1
in
10
year
mean
yearly
surface
water
concentration.
EFED's
surface
water
modeling
for
drinking
water
uses
a
default
percent
cropped
area
factor
(
PCA)
for
turf,
which
represents
the
fraction
of
the
watershed
that
is
cropped
and
treated
with
the
pesticide
being
modeled.
In
the
absence
of
a
crop
specific
PCA
factor,
a
default
PCA
of
8
0.87
is
used.
The
0.87
factor
represents
the
maximum
fraction
of
a
watershed
in
the
US
that
is
agriculturally
cropped.
This
default
PCA
was
used
for
fenarimol
modeling
on
turf.
EFED
is
currently
attempting
to
develop
PCA
factors
specific
for
turf
scenarios,
and
recognizes
that
it
is
unlikely
that
87%
of
a
watershed
used
for
drinking
water
would
be
grown
to
turf
and
treated
with
fenarimol
at
the
maximum
rate
allowed
only
for
turf
applications.
The
default
PCA
factor
assumed
and
used
in
fenarimol
modeling
is
most
likely
overestimated
and
adds
to
the
conservatism
of
the
assessment.
Given
the
relatively
low
usage
of
fenarimol
across
the
country
it
is
highly
unlikely
that
the
amount
applied
to
the
watershed
in
the
model
will
be
concentrated
in
any
real
watershed
used
to
derive
drinking
water.
In
summary,
the
surface
water
EEC
is
not
likely
to
underestimate
exposure
to
fenarimol
and
its
degradates
based
on
the
conservative
inputs
to
the
model
(
i.
e.,
default
PCA,
no
decay
via
the
major
degradation
pathway,
and
the
concentrated
application
scenario
modeled
is
unlikely
to
occur
in
a
real
watershed
where
drinking
water
is
derived).
The
uncertainties
related
to
the
aqueous
photoproducts
would
likely
be
addressed
through
completion
of
a
satisfactory
guideline
aqueous
photolysis
study.
Other
uncertainties
would
likely
be
addressed
through
the
satisfactory
completion
of
other
outstanding
guideline
studies,
as
detailed
by
EFED.
Residential
Exposure
and
Risk
Estimates
Potential
residential
exposures
may
occur
as
a
result
of
applications
of
fenarimol
to
residential
lawns
or
turf
by
residents
and
by
professional
lawn
care
operators
(
LCOs).
However,
HED
has
been
informed
by
SRRD
that
the
registrants
have
agreed
to
amend
their
product
labels
to
prohibit
residential
use
and
handling
(
i.
e.
mixing,
loading
or
applying)
of
fenarimol
in
residential
settings.
Applications
to
turf
will
be
limited
to
golf
courses,
and
stadium
fields
or
professional
athletic
fields
only.
Therefore,
residential
handler
and
residential
postapplication
exposure
scenarios
should
no
longer
exist.
The
only
non
occupational
postapplication
exposure
scenario
remaining
to
evaluate
is
short
term
dermal
exposure
to
adult
golfers.
Applications
to
residential
turf
will
not
be
permitted
by
products
labels
until
such
time
as
additional
toxicity
data
are
submitted
and
reviewed.
Then
the
Agency
will
reevaluate
the
risk
assessment
for
residential
uses.
Residential
exposures
have
been
estimated
based
on
label
application
rates
and
frequency,
and
the
persistence
of
fenarimol.
Several
post
application
exposure
scenarios
following
application
to
turf
are
anticipated;
however,
if
registrants
amend
their
product
labels
to
prohibit
residential
use
and
handling
of
fenarimol
in
residential
settings,
as
they
have
agreed
to
do,
then
the
only
non
occupational
postapplication
exposure
scenario
remaining
to
evaluate
is
short
term
dermal
exposure
to
adult
golfers.
The
updated
Residential
SOPs
were
used
to
address
the
exposures
of
adult
golfers
contacting
treated
turf.
The
SOPs
for
turf
use
transfer
coefficients
based
on
mowing
studies.
Chemical
specific
data
from
a
turf
transferable
residue
(
TTR)
study
were
available;
however,
these
TTR
data
were
unacceptable
for
use
in
postapplication
exposure
assessment.
Therefore,
default
assumptions
from
the
SOPs
were
used.
Risk
estimates
for
short
term
dermal
contact
with
treated
turf
during
the
low
contact
activity
of
golfing
resulted
in
a
margin
of
exposure
(
MOE)
of
14,000,
which
does
not
exceed
the
level
of
concern,
a
MOE
of
900.
9
N
N
OH
Cl
Cl
Based
upon
the
slow
dissipation
rate
of
fenarimol
and
the
possibility
of
multiple
applications
to
turf,
intermediate
term
exposures
of
adult
golfers
are
possible.
However,
if
registrants
amend
their
product
labels
to
increase
the
minimum
re
application
interval
to
turf
to
30
days,
as
they
have
agreed
to
do,
then
intermediate
term
exposures
should
no
longer
exist.
Mitigating
circumstances
for
exposure
to
fenarimol
residues
may
include
watering
in
after
application
to
turf.
This
instruction,
however,
does
not
prevent
contact
with
treated
turf
prior
to
watering
in.
The
current
granular
label
(
EPA
Reg.
No.
228
298)
recommends,
but
does
not
require
watering
in.
The
soluble
concentrate
label
(
EPA
Reg.
No.
62719
142)
does
not
mention
watering
in.
Therefore,
label
language
should
be
strengthened
to
ensure
that
watering
in
occurs
immediately
after
application.
When
fenarimol
is
applied
to
stadium
or
professional
athletic
fields,
applicators
should
water
in
product
immediately
after
application,
or
do
not
enter
or
allow
others
to
enter
treated
area
for
24
hours
after
application.
If
product
is
watered
in
after
treatment,
do
not
enter
or
allow
other
persons
to
enter
until
area
has
dried.
Aggregate
Exposure
and
Risk
Estimates
Because
no
acute
toxicity
endpoint
was
identified
for
risk
assessment,
an
aggregate
acute
risk
assessment
was
not
conducted.
Short
term
dermal
postapplication
exposures
for
adults
golfing
were
combined
with
average
dietary
(
food
&
water)
exposures
in
a
short
term
aggregate
risk
assessment.
This
aggregate
risk
estimate
did
not
exceed
the
Agency's
level
of
concern.
The
exposure
from
food
is
insignificant
(<
1%
cPAD)
for
adults;
therefore,
the
aggregate
risk
estimates
include
only
dermal
and
water
exposures.
The
short
term
DWLOCs
for
adults
are
well
above
the
estimated
EECs
for
ground
and
surface
water,
and
indicate
that
combined
short
term
dietary
(
food
&
water)
and
dermal
exposures
do
not
exceed
the
Agency's
level
of
concern.
Risk
estimates
for
chronic
aggregate
exposures
to
fenarimol
in
food
and
water
do
not
exceed
levels
of
concern.
2.0
PHYSICAL
CHEMICAL
PROPERTIES
CHARACTERIZATION
The
chemical
name
for
fenarimol
is
alpha(
2
chlorophenyl)
alpha(
4
chlorophenyl)
5
pyridinemethanol.
The
structure
is
as
follows:
Empirical
Formula:
C
17
H
12
Cl
2
N
2
O
10
Molecular
Weight:
331.2
CAS
Registry
No.:
60168
88
9
PC
Code:
206600
Fenarimol
is
a
white
to
buff
crystalline
solid
with
a
melting
point
of
117
119
C,
bulk
density
of
0.66
0.81
g/
cc
(
packed),
octanol/
water
partition
coefficient
(
log
K
ow)
of
3.69,
and
vapor
pressure
of
2.2
x
10
7
Torr
at
25
C.
Fenarimol
is
practically
insoluble
in
water
(
13.7
ppm
at
pH
7
and
25
C)
and
is
soluble
in
most
organic
solvents:
hexane
(
1.1
mg/
mL);
acetonitrile,
heavy
aromatic
naphtha,
and
xylene
(
50
mg/
mL);
benzene
and
methanol
(
100
125
mg/
mL);
acetone
(>
250
mg/
mL);
and
chloroform
and
cyclohexanone
(>
500
mg/
mL).
3.0
HAZARD
CHARACTERIZATION
3.1
Hazard
Profile
Toxicology
data
are
used
by
HED
to
assess
the
potential
hazards
to
humans.
The
data
are
derived
from
a
variety
of
acute,
subchronic,
and
chronic
toxicity
tests;
developmental/
reproductive
tests;
and
tests
to
assess
mutagenicity
and
pesticide
metabolism.
The
database
for
fenarimol
is
adequate
to
support
this
TRED.
Acute
toxicity
values
and
toxicity
categories
for
fenarimol
are
summarized
in
Table
1.
The
data
indicate
that
fenarimol
has
low
acute
oral,
dermal,
and
inhalation
toxicity
(
category
III).
Fenarimol
is
category
II
with
respect
to
ocular
irritation.
It
is
not
a
dermal
sensitizer.
A
primary
dermal
irritation
study
is
not
available.
11
Table
1.
Acute
Toxicity
of
Fenarimol.
Study
Type
MRID
No.:
Result
870.1100
Acute
Oral
Toxicity
rat.
Elanco,
Study
No.:
R
O
289
82,
December
30,
1982
00125392
LD50
>
599
mg/
kg.
Toxicity
Category
III
Classification:
Guideline
870.1200
Acute
Dermal
Toxicity
rabbit.
Elanco
Study
No.:
B
D
27
82,
February
17,
1983
00125392
LD50
>
1998
mg/
kg.
Toxicity
Category
III
Classification:
Minimum
870.1300.
Acute
Inhalation
Toxicity
rat.
Elanco,
Study
No.:
R
H
102
82,
November
16,
1982.
00125292
LC50
>
5.20
mg/
L
for
males.
LC50
between
2.87
and
5.2
mg/
L
for
females.
Toxicity
Category
III
Classification:
Guideline
870.2400
Primary
Ocular
Irritation
Rabbit.
Elanco,
Study
No.:
B
E
32
82,
February
1,
1982
00125392
Day
1:
6/
6
corneal
opacity
(
score
of
5);
5/
6
iris
irritation
(
score
5);
6/
6
conjunctival
irritation
(
score
of
1
2).
Day
7:
3/
6
corneal
opacity
and
conjunctival
irritation.
Day
14
all
irritation
cleared.
Toxicity
Category
II
Classification:
Minimum
870.2500
Primary
Dermal
Irritation
rabbit.
No
study
available.
870.2600
Dermal
Sensitization
guinea
pig.
Elanco,
Study
No.;
GP
9538,
January
1,
1980.
00084966
No
evidence
of
sensitization
in
the
Guinea
Pig
Maximization
test
of
Magnusson
and
Kligman.
Classification:
Minimum.
Table
2
presents
a
summary
of
subchronic
and
chronic
toxicity
studies
for
fenarimol.
Subchronic
oral
dosing
in
rats
demonstrates
very
little
toxicity
except
for
some
slight
body
weight
changes
and
liver
pathology
of
low
degree
and
inconsistency.
In
dogs
there
was
also
little
overt
toxicity
with
there
being
some
effects
in
the
liver.
A
28
day
subchronic
inhalation
study
is
required.
The
Gowan
Company
requested
that
the
Agency
rescind
the
data
requirement
for
the
28
day
inhalation
study.
They
disagree
on
its
need
and
cite
that
this
issue
was
addressed
recently
by
CropLife
America,
an
industrial
organization.
They
also
stated
that
the
sprays
that
will
typically
result
from
fenarimol
use
will
have
droplets
that
will
be
tens
or
thousands
of
micrometers
in
diameter
or
much
larger
than
the
respirable
droplets
of
a
few
micrometers
in
diameter.
These
larger
droplets
will
not
reach
the
alveoli
and
will
become
trapped
in
the
upper
respiratory
tract
and
eventually
swallowed.
Thus,
they
contended
that
the
endpoint
from
an
oral
toxicity
study
is
a
more
appropriate
endpoint.
In
a
written
response
to
comments
(
5/
8/
02),
the
HED
stated
there
have
been
some
recent
changes
in
HED
policy
regarding
the
need
for
subchronic
inhalation
toxicity
studies.
The
comments
of
the
CropLife
America
organization
have
been
taken
into
consideration
at
a
recent
presentation
to
the
Agency.
As
a
result
of
these
recent
changes,
the
Gowan
Company
may
submit
a
waiver
for
the
28
day
inhalation
study.
This
waiver
must
contain
sufficient
data
on
the
particle
size
of
the
sprays
and
other
preparations
that
may
result
in
inhalation
exposure.
It
also
must
contain
sufficient
other
information
regarding
the
potential
inhalation
exposure
such
as
duration
of
exposure
in
terms
of
hours
per
day,
per
week,
etc.
The
12
completed
waiver
request
will
be
presented
to
a
peer
review
committee
that
will
determine
the
need
for
the
subchronic
inhalation
toxicity
study.
This
peer
review
group
will
consist
of
toxicologists
with
expertise
in
inhalation
toxicology
as
well
as
occupational
and
residential
exposure
representatives.
The
decision
on
the
need
for
the
subchronic
inhalation
toxicity
study
will
be
based
on
all
relevant
factors.
The
more
complete
the
information
in
the
waiver
request
is,
the
better
the
chance
for
the
waiver
to
be
granted.
The
limited
information
provided
in
the
April
10,
2002
letter
is
not
sufficient
to
bring
to
a
peer
review
committee
to
consider
a
waiver
for
an
inhalation
toxicity
study.
Lastly,
the
HED
is
already
using
an
oral
toxicity
endpoint
for
the
inhalation
exposure
scenarios.
However,
the
subchronic
inhalation
toxicity
study
is
considered
more
appropriate
for
risk
assessment
based
on
inhalation
exposures.
Adequate
data
are
available
to
assess
the
chronic
toxicity
and
carcinogenic
potential
of
fenarimol.
The
liver
appears
to
be
the
most
evident
target
organ
for
chronic
toxicity
aside
from
the
effects
of
fenarimol
on
aromatase.
Liver
toxicity
was
manifested
by
liver
weight
increases
and
the
presence
of
"
fatty
liver"
in
rats.
In
dogs,
liver
weight
was
increased
and
there
was
also
associated
increases
in
serum
enzymes
to
indicate
liver
toxicity.
p
Nitroanisole
o
demethylase
was
also
increased
indicating
stimulation
of
liver
enzymes.
Fenarimol
has
been
classified
as
a
Group
E
"
not
likely"
carcinogen
(
no
evidence
of
carcinogenicity
for
humans).
Similarly,
the
genetic
toxicity
data
indicate
there
is
no
mutagenicity
concern.
Developmental
studies
in
rats
and
rabbits,
designed
to
identify
possible
adverse
effects
on
the
developing
organism
which
may
result
from
the
in
utero
exposure
to
the
pesticide
were
also
conducted.
The
data
base
for
prenatal
developmental
toxicity
is
considered
complete.
The
initial
guideline
study
was
classified
as
unacceptable,
but
this
study
together
with
a
special
study
to
assess
for
the
reversibility
of
hydronephrosis
are
combined
with
another
special
study
to
assess
for
reproductive
performance.
All
of
these
studies
combine
to
make
an
acceptable
study
and
to
satisfy
the
guideline
requirement.
The
rat
studies
revealed
that
fenarimol
is
associated
with
hydronephrosis
that
is
reversible.
The
developmental
toxicity
studies
showed
no
evidence
of
increased
sensitivity
or
susceptibility
of
young
rats
or
rabbits
following
pre
or
postnatal
exposure
to
fenarimol.
The
data
base
for
reproductive
toxicity
is
considered
complete.
The
multi
generation
reproduction
studies
indicate
that
fenarimol
causes
reduced
fertility
and
dystocia.
Separate
cross
dosing
studies
(
dosing
males
and
mating
with
untreated
females
and
dosing
females
and
mating
with
untreated
males)
indicated
that
the
reduced
fertility
is
due
to
an
effect
in
males
and
the
dystocia
is
an
effect
in
females.
These
effects
of
fenarimol
were
attributed
to
inhibition
of
aromatase
or
the
enzyme
that
converts
androgens
to
estrogens.
In
addition
to
the
guideline
multi
generation
reproduction
study
in
rats,
there
are
nonguideline
studies
that
assess
for
the
reproductive
performance
in
mice
(
MRID
No.:
45502307),
guinea
pigs
(
MRID
No.:
00126525,
00133474
and
00137159)
and
rabbits
(
MRID
No.:
00084967).
The
mouse
study
indicated
that
mice
are
similar
to
rats
in
that
there
is
a
decrease
in
the
reproductive
performance
in
the
males.
However,
neither
the
guinea
pig
or
rabbit
studies
demonstrated
a
decrease
in
reproductive
performance
indicating
that
the
effect
of
fenarimol
on
male
reproductive
performance
is
not
seen
in
all
species
tested.
13
There
is
no
Guideline
870.7600
dermal
absorption
study
available
with
rats.
The
upper
bound
limit
for
dermal
absorption
was
estimated
by
HIARC
(
J.
Doherty,
9/
6/
01)
to
be
20%
based
on
an
assessment
of
the
rabbit
and
monkey
dermal
absorption
studies
along
with
a
comparison
of
the
rabbit
developmental
toxicity
and
rabbit
21
day
dermal
toxicity
studies.
Subsequently,
Gowan
Company
responded
by
submitting
additional
information
regarding
the
dermal
absorption
study
in
monkeys,
as
well
as
other
background
information.
This
information
was
evaluated
during
a
special
HIARC
revisit,
on
5/
23/
02.
The
HIARC
decided
that
a
5%
dermal
absorption
factor
is
appropriate
to
use
for
risk
assessment
purposes.
The
5%
dermal
absorption
factor
was
derived
primarily
from
the
monkey
dermal
absorption
study
(
MRID
No.:
00162538,
1985)
using
the
Feldman
Maibach
model.
Dermal
absorption
rates
of
1.36%,
2.32%,
3.12%
and
4.12%
(
mean
2.73%
±
1.17%)
were
observed
for
the
four
individual
monkeys
in
the
study.
However,
from
8
to
29%
of
the
dermally
applied
radioactivity
was
not
accounted
for.
Since
there
was
variation
in
the
dermal
absorption
in
the
four
monkeys
and
there
was
unaccounted
for
radioactivity,
a
dermal
absorption
value
of
5%
from
this
study
was
considered
appropriate
for
risk
assessment.
In
addition,
the
result
of
a
dermal
absorption
study
with
rabbits
(
MRID
No.:
00046639,
1980),
using
three
formulations,
indicated
up
to
approximately
15%
dermal
absorption.
By
comparison
the
rabbit
developmental
toxicity
study
(
MRID
No.:
47716001)
and
the
rabbit
21
day
dermal
toxicity
study
(
MRID
No.:
00153312)
also
indicated
approximately
15%
dermal
absorption.
However,
the
rabbit
is
recognized
as
being
a
poor
model
for
estimating
dermal
absorption
in
humans,
since
rabbit
skin
is
more
permeable;
therefore,
the
5%
value
based
primarily
on
the
monkey
study
is
considered
appropriate.
Refer
to
the
Third
Report
of
the
HIARC
(
J.
Doherty,
7/
29/
02)
for
a
more
detailed
discussion
of
dermal
absorption.
The
database
for
metabolism
is
considered
to
be
complete.
The
biliary
route
is
the
predominant
route
of
elimination
in
the
rat
but
the
urinary
route
is
the
most
prominent
route
of
elimination
in
the
rabbit.
In
rats,
fenarimol
is
rapidly
absorbed
from
the
gastro
intestinal
tract
and
the
half
life
of
the
plasma
level
was
determined
to
be
11.8
to
16.8
hours.
Most
of
the
radiolabeled
material
was
recovered
in
the
urine
(
5
to
15%)
or
feces
(~
80%
of
the
recovered
isotope)
by
day
7.
Biliary
excretion
was
the
major
route
of
elimination.
Fenarimol
is
extensively
metabolized
in
the
rat;
less
than
one
percent
of
the
parent
is
recovered,
while
more
than
30
metabolites
are
recovered.
Metabolism
of
fenarimol
occurs
by
the
oxidation
of
the
carbinol
phenyl
ring
and
pyrimidine
ring
and
some
qualitative
and
quantitative
differences
in
sexes
and
dose
level
were
noted.
There
are
no
acute,
subchronic
or
developmental
neurotoxicity
studies
available.
The
HIARC
(
July
10,
2001)
determined
that
a
special
developmental
study
with
special
inclusions
to
assess
for
hormonal
effects
in
adults
and
post
weaning
pups,
and
in
vivo
inhibition
of
aromatase
should
be
required.
Acute
and
subchronic
neurotoxicity
studies
are
not
required.
The
toxicology
profile
of
fenarimol
is
shown
in
Table
2
of
this
document.
14
Table
2.
Toxicology
Profile
for
Fenarimol.
Guideline
No./
Study
Type
MRID
No.
(
year)/
Classification
/
Doses
Results
870.3100
(
12
and
18
month
oral
toxicity
rodents
fulfill
this
guideline)
00235175,
45502302
and
45502304
(
1978)/
Acceptable/
Non
Guideline
0,
2.5,
6.5
or
17.5
both
sexes.
NOAEL
=
6.5
mg/
kg/
day
LOAEL
=
17.5
mg/
kg/
day
based
on
increased
relative
liver
weight
and
increased
severity
of
fatty
liver.
870.3150
90
Day
oral
toxicity
in
nonrodents
00056090
(
1975)/
Acceptable/
Guideline
0,
1.25,
5
or
20
mg/
kg/
day.
NOAEL
and
LOAEL
>
20
mg/
kg/
day
(
HDT).
A
one
year
study
(
MRID
00146959
satisfies
this
guideline).
870.3200
21/
28
Day
dermal
toxicity
(
rat)
00153312
(
1985)
Acceptable/
Guideline
0,
500
or
1000
mg/
kg/
day
for
RUBIGAN
(
emulsifiable)
formulation
and
1000
mg/
kg/
day
for
technical
fenarimol.
NOAEL
<
1000
mg/
kg/
day
LOAEL
=
1000
mg/
kg/
day
based
on
slight
liver
weight
effects.
Although
this
study
is
acceptable,
it
is
of
limited
usefulness
for
risk
assessment
because
it
did
no
assess
for
reproductive
effects
or
possible
effects
on
aromatase.
870.3250
90
Day
dermal
toxicity
No
study.
No
study.
870.3465
90
Day
inhalation
toxicity
No
study.
No
study
870.3700a
Prenatal
developmental
in
rodents
00042543/(
1979)
Unacceptable/
Guideline
but
acceptable
with
other
studies
(
see
below).
0,
5,
13,
35
mg/
kg/
day
Maternal
NOAEL
>
35
mg/
kg/
day
(
HDT)
LOAEL
not
established
Developmental
NOEL
=
13
mg/
kg/
day
LOAEL
=
35
mg/
kg/
day
based
on
hydronephrosis
(
this
effect
was
shown
to
be
reversible
and
is
not
considered
adverse).
Special
study
to
assess
for
reversibility
of
hydronephrosis.
00132988/(
1983)
Acceptable/
Non
Guideline.
0
and
35
mg/
kg/
day.
Maternal
NOAEL
=
not
established
LOAEL
=
35
mg/
kg/
day
based
on
sporadic
dystocia.
Developmental
NOEL
<
35
mg/
kg/
day.
LOAEL
=
35
mg/
kg/
day
based
on
kidney
effects
(
hydronephrosis,
this
effect
was
shown
to
be
reversible
and
is
not
considered
adverse)
Above
two
studies
combine
to
satisfy
the
guideline
requirement
for
a
developmental
toxicity
study
in
rats.
870.3700b
Prenatal
developmental
in
rabbits
44716001/
1990/
Acceptable/
Guideline
0,
15,
50
or
150
mg/
kg/
day.
Maternal
NOAEL
=
50
mg/
kg/
day
LOAEL
=
150
mg/
kg/
day
based
on
increased
abortions
and
decreased
body
weights
and
gain
and
food
consumption.
Developmental
NOAEL
=
>
150
mg/
kg/
day
Guideline
No./
Study
Type
MRID
No.
(
year)/
Classification
/
Doses
Results
15
870.3800
Reproduction
and
fertility
effects
00235175,
45502301
(
1977)
Unacceptable/
Not
upgradeable
0,
2.9,
7.9
or
20
mg/
kg/
day
in
males;
0,
3.4,
9
or
23.5
mg/
kg/
day
in
females.
Parental/
Systemic
NOAEL
>
23.5
mg/
kg/
day
(
HDT)
LOAEL
not
established
Reproductive
LOAEL
<
2.9
mg/
kg/
day
based
on
decreased
fertility
in
the
F1
generation
second
mating.
Offspring
NOAEL
and
LOAEL
could
not
be
established
due
to
anti
fertility
effects
in
the
parental
generations,
which
prevented
valid
assessment
of
the
pup
generations.
Second
study
00235175,
45502302
(
1978)
Acceptable/
Guideline
0,
0.6,
1.2,
2.5
mg/
kg/
day
in
males
and
0,
0.8,
1.7
or
3.2
mg/
kg/
day
in
females.
Parental/
Systemic
NOAEL
>
2.5
mg/
kg/
day
in
males
and
3.2
mg/
kg/
day
in
females
(
HDT)
LOAEL
not
established
Parental
Reproductive
NOAEL
=
0.6
mg/
kg/
day
LOAEL
=
1.2
mg/
kg/
day
based
on
decreased
liveborn
litter
size
in
the
F1
and
F2
generations.
Offspring.
NOAEL
=
1.2
mg/
kg/
day.
LOAEL
=
2.5
mg/
kg/
day
based
on
decreased
survival
indices
and
possible
presence
of
hydronephrosis
Above
two
studies
combine
to
satisfy
the
guideline
requirement
for
a
multi
generation
reproduction
study
in
rats.
870.3800
Reproduction
and
fertility
effects
(
Special
Study)
00084968
Acceptable/
Non
Guideline
0,
35
mg/
kg/
day
LOAEL
for
males
and
females
>
35
mg/
kg/
d
(
males
decreased
mating
and
epididymal
weight,
females
dystocia
and
related
parameters)
NOAEL
not
established
870.4100a
Chronic
toxicity
rodents
See
combined
chronic
feeding
and
carcinogenicity
study.
870.4100b
Chronic
toxicity
dogs
00146959/
1985/
Acceptable/
Guideline
0,
1.25,
12.5
or
125
mg/
kg/
day.
NOAEL
=
12.5
mg/
kg/
day
LOAEL
=
125
mg/
kg/
day
based
on
reversible
increase
in
liver
weight
and
increase
in
alkaline
phosphatase.
870.4200
Combined
Chronic
Feeding
and
Carcinogenicity
rats
00235175/
1978/
Acceptable/
Guideline
0,2,
5.3,
or
14.6
mg/
kg/
day
for
male
and
0,
2.8,
7.6
or
21.55
mg/
kg/
day
for
females.
NOAEL
=
5.3
mg/
kg/
day.
LOAEL
=
14.6
mg/
kg/
day
based
on
hormonal
changes
(
prolactin
and
luteinizing
hormone)
and
possibly
fatty
liver
change
and
decreased
WBC
count
in
females.
870.4200
Combined
Chronic
Feeding
and
Carcinogenicity
rats
00153313/
1985/
Acceptable/
Guideline
0.5,
1,
2
mg/
kg/
day
for
males
and
0,
0.6,
1.2
or
2.3
mg/
kg/
day
for
females.
NOAEL
=
1
mg/
kg/
day
in
males
and
>
2.3
mg/
kg/
day
in
females.
LOAEL
=
2
mg/
kg/
day
in
males
based
on
minimal
gross
and
microscopic
changes
in
liver
and
possibly
testis.
There
was
no
evidence
of
carcinogenicity
or
increase
in
liver
tumors.
Guideline
No./
Study
Type
MRID
No.
(
year)/
Classification
/
Doses
Results
16
The
above
two
studies
combine
to
satisfy
the
guideline
requirement
for
carcinogenicity
testing
in
rats.
It
should
be
noted
that
the
potential
for
fenarimol
to
cause
decreased
fertility
and
dystocia
at
the
dose
levels
tested
in
the
rat
studies
contributed
to
the
weight
of
evidence
that
the
rat
was
assessed
at
adequate
dose
levels.
870.4300
Carcinogenicity
mice
0071920/
1978/
Acceptable/
Guideline
0,
7,
24
and
86
mg/
kg/
day
for
both
sexes.
NOAEL
=
>
86
mg/
kg/
day
(
HDT).
The
HIARC
and
CARC
concluded
that
there
was
no
evidence
of
carcinogenicity
although
liver
tumors
were
highest
in
the
high
dose
group
but
incidence
was
considered
too
low
to
be
meaningful.
Mutagenticity
870.
See
Table2.
a.
below.
870.6200a
Acute
neurotoxicity
screening
battery
No
study.
No
study.
Not
required.
870.6200b
Subchronic
neurotoxicity
screening
battery
No
study.
No
study.
Not
required.
870.6300
Developmental
neurotoxicity
Study
is
being
required
and
special
inclusions
to
assess
for
possible
effects
due
to
hormonal
disruption
required.
870.7485
Metabolism
and
pharmacokinetics
00261349
and
00261350
(
1985)
A
series
of
studies
with
radioactive
label
in
different
positions
established
that
fenarimol
is
readily
absorbed
and
excreted
with
the
biliary
route
being
most
important
in
rats
but
the
urinary
route
being
important
in
rabbits.
Metabolism
was
extensive
with
30
or
more
metabolites
noted.
Little
radioactivity
remained
in
the
tissue.
Guideline
No./
Study
Type
MRID
No.
(
year)/
Classification
/
Doses
Results
17
870.7600
Dermal
absorption
monkeys
00162538
(
1985)
A
5%
dermal
absorption
factor
is
appropriate
to
use
for
risk
assessment
purposes.
It
was
derived
primarily
from
the
monkey
study
(
00162538)
using
the
Feldman
Maibach
model.
Dermal
absorption
rates
of
1.36%,
2.32%,
3.12%
and
4.12%
(
mean
2.73%
±
1.17%)
were
observed
for
the
four
individual
monkeys.
However,
from
8
to
29%
of
the
dermally
applied
radioactivity
was
not
accounted
for.
Since
there
was
variation
in
the
dermal
absorption
in
the
four
monkeys
and
there
was
unaccounted
for
radioactivity,
a
value
of
5%
was
considered
appropriate.
In
addition,
the
result
of
a
dermal
absorption
study
with
rabbits
(
00046639),
using
three
formulations,
indicated
up
to
approximately
15%
dermal
absorption.
By
comparison
the
rabbit
developmental
toxicity
study
(
47716001)
and
the
rabbit
21
day
dermal
toxicity
study
(
00153312)
also
indicated
approximately
15%
dermal
absorption.
However,
the
rabbit
is
recognized
as
being
a
poor
model
for
estimating
dermal
absorption
in
humans,
since
rabbit
skin
is
more
permeable;
therefore,
the
5%
value
based
primarily
on
the
monkey
study
is
considered
appropriate.
Special
studies
Several
special
studies
were
presented
to
investigate
the
mechanism
of
the
decreased
fertility
and
dystocia.
These
are
listed
above
in
this
table
under
the
heading
for
the
study
type
which
they
most
closely
resemble
(
i.
e.
reproduction
or
developmental)
Table
2.
a.
Mutagenticity/
Genotoxicity
Studies
Study
Results
Bacterial
mutagenicity
(
Ames
test)
Salmonella
typhimurium
and
Escherichia
coli.
Elanco,
1976.
MRID
No.:
243372
(
Acc.
No.:).
Not
mutagenic
with
and
without
metabolic
activation
at
doses
up
to
100
g/
plate.
Classification:
"
Minimum"
(
Acceptable)
Forward
mutation
assay
in
TK
±
mouse
lymphoma
assay.
Elanco,
August
1,
1979.
MRID
No.:
00042538
No
evidence
of
mutagenicity
when
tested
at
0,
3,
6,
12,
50
or
100
g/
mL.
The
100
g/
mL
dose
level
was
toxic.
Classification:
"
minimum"
(
acceptable).
DNA
repair
synthesis.
Elanco,
Study
No.:
790503
1,
June
1979.
MRID
No.:
00042541
No
evidence
of
induction
of
DNA
repair
at
dose
levels
of
0,
0.05,
0.1,
0.5,
10,
50
or
100
nanomoles/
mL
for
five
hours
incubation.
Cytotoxicity
resulted
at
50
and
100
nano
moles/
mL.
Classification:
"
minimum"
(
acceptable).
In
vivo
cytogenetics
in
hamsters.
Cabinet
d'Etudes
et
de
Recherches
en
Tox.
Study
No.:
658,
May
10,
1982.
MRID
No.:
00144051
Negative
for
mutagenic
effects
at
does
of
250
mg/
kg
(
times
2
doses)
in
bone
marrow
cells.
Classification:
Acceptable.
Study
Results
18
micronucleus
assay
mouse
Cabinet
d'Etudes
et
de
Recherches
en
Tox.
Study
No.:
650,
May
1,
1982.
MRID
No.:
00144050
Positive
for
clastogenic
effects
in
male
mice
at
1
gm/
kg
at
24
hours.
Assessments
at
48
and
72
hours
were
considered
confounded
since
there
were
no
positive
controls.
Classification:
UNACCEPTABLE
for
48
and
72
hours.
ACCEPTABLE
for
24
hours.
Evaluation
of
carcinogenicity
in
the
mouse
C3H/
10T
½
embryonic
mouse
fibroblast
culture
system.
Elanco,
August
1,
1980.
MRID
No.:
00046637.
No
malignant
transformations
were
observed
in
fenarimol
treated
cultures
between
4
and
256
nanomoles/
mL.
Classification:
"
minimum"
(
acceptable).
Dominant
lethal
rat.
Lilly,
Study
No.:
R
346
January,
1977
MRID
No.:
00042542
A
single
dose
of
350
mg/
kg
fenarimol
(
in
acacia
solution)
did
not
result
in
symptoms
of
toxicity
to
the
males
and
did
not
indicate
a
dominant
lethal
effect
when
the
rats
were
mated
4
days
after
treatment.
Classification:
"
minimum"
(
acceptable).
Armoatase
inhibition
assay
in
stimulated
rat
ovarian
microsomal
system.
Elanco,
January
1,
1982.
MRID
No.:
00093876
Fenarimol
is
a
moderately
weak
inhibitor
of
aromatase
activity
in
the
stimulated
rat
ovarian
microsomal
system
Classification:
Supplementary.
3.2
FQPA
Considerations
The
FQPA
Safety
Factor
committee
addressed
the
potential
enhanced
sensitivity
of
infants
and
children
from
exposure
to
fenarimol
as
required
by
the
FQPA
of
1996.
The
HIARC
examined
the
prenatal
developmental
toxicity
studies
in
rats
and
rabbits
and
the
two
generation
reproduction
study
in
rats,
and
concluded
that
the
database
does
not
show
evidence
of
increased
susceptibility
to
fetuses
and
young
(
HIARC,
9/
5/
01).
The
HIARC
determined
that
a
special
developmental
toxicity
study
should
be
required
based
on
the
need
to
determine
if
the
potential
hormonal
effects
as
elicited
by
inhibition
of
aromatase
will
result
in
effects
in
the
rat
pups.
The
HIARC
confirmed
this
decision
on
May
23,
2002
during
a
revisit
of
the
issue
in
response
to
comments
received
on
4/
11/
02,
Gowan
Company
requesting
that
the
HED
re
evaluate
the
need
for
a
developmental
neurotoxicity
(
DNT)
study.
In
accordance
with
the
2002,
OPP
Guidance
Document
on
Determination
of
the
Appropriate
FQPA
Safety
Factor(
s)
in
Tolerance
Assessment,
this
data
requirement
is
considered
to
be
"
for
cause"
and
therefore
the
HIARC
concluded
(
July
29,2002;
TXR
No.
0050977)
that
a
Database
Uncertainty
Factor
of
3X
is
required
until
the
data
are
received
and
evaluated.
Evidence
suggesting
a
special
developmental
toxicity
study
to
assess
hormonal
effects
is
needed
is
given
below.
The
NOAEL
and
LOAEL
for
risk
assessments
are
based
on
reduced
fertility
in
males
and
dystocia
in
females
associated
with
fenarimol's
potential
to
affect
hormones
in
adult
rats.
The
potential
for
fenarimol
to
affect
the
hormonal
system
in
developing
rats
needs
to
be
assessed
to
determine
if
the
developing
fetus
and
neonate
may
also
be
affected
as
can
be
judged
by
the
special
developmental
toxicity
study
that
will
have
special
emphasis
on
potential
19
disruption
of
the
hormonal
system
by
biochemical
methods
and
include
special
provisions
to
assess
for
physiological
manifestations
of
hormonal
disruption.
The
LOAEL
on
which
risk
assessments
are
based
is
related
to
potential
hormonal
effects.
This
study
should
follow
the
same
dosing
regimen
as
a
developmental
neurotoxicity
study,
but
does
not
need
to
include
all
of
the
functional
observational
battery
(
FOB)
assessments.
The
protocol
for
this
study
should
be
submitted
to
HED
for
review
prior
to
initiating
the
study.
Based
on
the
HIARC
determinations,
the
FQPA
Safety
Factor
Committee
(
SFC)
initially
recommended
that
the
10x
Safety
Factor
should
be
retained
at
10x
for
all
populations
and
all
fenarimol
risk
assessments
fenarimol
due
to
the
following
data
gaps
(
B.
Tarplee,
9/
28/
01):
a
special
developmental
toxicity
study
with
fenarimol
is
required
to
determine
if
the
potential
hormonal
effects
elicited
by
inhibition
of
aromatase
will
result
in
effects
in
the
rat
pups;
and
the
environmental
fate
database
is
incomplete
for
the
aquatic
photolytic
degradate
of
fenarimol,
4
chloro
2(
5
pyrimidyl)
2'
chlorobenzophenone.
Consequently,
the
photolytic
degradate
was
not
included
in
the
assessment
and
there
was
residual
uncertainty
that
the
drinking
water
assessment
may
underestimate
exposure.
In
a
revisit
meeting
on
July
29,
2002,
the
FQPA
SFC
reevaluated
fenarimol
because
the
Environmental
Fate
and
Effects
Division
(
EFED)
received
additional
information
on
the
aquatic
photo
degradate
of
concern,
and
subsequently
revised
the
drinking
water
assessment
for
fenarimol.
The
updated
drinking
water
assessment
(
July
31,
2002;
D284487)
was
revised
to
include
fenarimol
and
its
aquatic
photodegradates.
The
model
inputs
were
adjusted
so
that
aquatic
concentrations
were
estimated
assuming
no
aqueous
photolysis,
which
appears
to
be
fenarimol's
most
significant
route
of
dissipation
in
the
environment.
Minor
model
input
corrections
were
also
made
to
the
application
rate
and
interval.
The
result
provides
a
screening
level
estimate
of
combined
concentrations
of
fenarimol
and
its
aquatic
degradates
that
is
conservative
and
that
does
not
underestimate
exposure.
As
a
result
of
this
reassessment
the
chronic
EECs
increased
from
59
to
84
g/
L
for
surface
water,
and
from
14
to
16
g/
L
for
ground
water.
Although,
there
is
still
some
uncertainty
as
to
the
identity,
fate,
and
behavior
of
the
photolysis
degradates
of
fenarimol,
data
will
be
required
to
address
this
uncertainty.
The
FQPA
SFC
also
reassessed
the
uncertainty
surrounding
the
potential
effects
elicited
by
inhibition
of
aromatase
by
fenarimol.
The
FQPA
SFC
agreed
with
the
HIARC
conclusion
that
a
special
developmental
toxicity
study
to
assess
for
hormonal
effects
is
required
for
fenarimol,
and
a
database
uncertainty
factor
of
3x
is
required
until
the
data
are
received
and
reviewed.
Based
on
the
updated
drinking
water
assessment
and
the
recent
HIARC
conclusions
regarding
aromatase,
the
FQPA
SFC
recommended
that
the
FQPA
safety
factor
for
fenarimol
be
reduced
from
10x
to
3x.
3.3
Dose
Response
Assessment
and
Hazard
Endpoint
Selection
The
strengths
and
weaknesses
of
the
fenarimol
toxicology
database
were
considered
during
the
process
of
toxicity
endpoint
and
dose
selection.
In
general,
most
of
the
required
guideline
studies
on
fenarimol
were
available
and
provided
reasonable
confidence
when
the
toxicity
endpoints
and
doses
for
risk
assessment
were
selected.
Based
on
the
evaluation
of
the
above
summarized
studies,
the
Hazard
Identification
Assessment
Review
Committee
(
HIARC)
identified
the
toxicity
endpoints
and
20
the
dose
levels
for
use
in
risk
assessment
(
HIARC
document
of
9/
5/
01).
The
recently
updated
HIARC
report
(
July
29,2002;
TXR
No.
0050977)
did
not
change
any
toxicity
endpoints
or
dose
levels
for
use
in
risk
assessment.
The
selected
toxicity
endpoints
are
summarized
in
Table
3.
The
METARC
recommended
(
J.
Doherty,
9/
17/
01),
and
the
HIARC
confirmed,
that
the
reduced
male
fertility
and
dystocia
effects
of
fenarimol
should
be
endpoints
for
human
health
risk
assessment.
It
is
noted
that
the
endpoint
from
the
multi
generation
reproduction
study
is
based
on
decreased
litter
size.
This
decrease
in
litter
size
may
be
a
reflection
of
the
maternal
toxicity
or
the
potential
for
fenarimol
to
inhibit
aromatase.
In
this
regard,
it
is
a
meaningful
endpoint
for
all
populations,
males
and
females.
Consequently,
HED
identified
a
reference
dose
for
chronic
exposure
(
cRfD)
of
0.006
mg/
kg/
day
from
the
multi
generation
reproduction
study
based
on
a
no
observed
adverse
effect
level
(
NOAEL)
of
0.6
mg/
kg/
day,
and
a
10X
uncertainty
factor
for
interspecies
extrapolation
and
a
10X
uncertainty
factor
for
intraspecies
variation.
The
NOAEL
of
0.6
mg/
kg/
day
is
based
on
decreased
live
born
litter
size
in
the
F
1
and
F
2
generations
at
a
lowest
observed
adverse
effect
level
(
LOAEL)
of
1.2
mg/
kg/
day.
The
HED
calculated
a
chronic
Population
Adjusted
Dose
(
cPAD)
of
0.002
mg/
kg/
day.
The
cPAD
is
the
RfD
divided
by
the
FQPA
safety
factor
(
3X).
Chronic
dietary
exposure
estimates
greater
than
100%
of
the
cPAD
would
exceed
HED's
level
of
concern.
For
risks
associated
with
intermediate
term
(
IT)
exposures
(
1
6
months),
the
same
endpoint
(
NOAEL
of
0.6
mg/
kg/
day)
was
used
for
incidental
oral,
dermal,
and
inhalation
risk
assessments.
A
Margin
of
Exposure
or
MOE,
which
is
the
ratio
of
the
NOAEL
to
the
exposure
estimate,
of
greater
than
300
does
not
exceed
HED's
level
of
concern
for
IT
risk
assessments.
An
MOE
of
greater
than
300
is
required
because
of
the
10x
interspecies
factor,
the
10x
intraspecies
factor
and
the
3x
FQPA
factor.
However,
HED
has
been
informed
by
SRRD
that
the
registrant
has
agreed
to
amend
their
product
labels
to
extend
the
re
application
interval
to
turf
to
30
days;
thereby
eliminating
any
residential
intermediate
term
exposure
scenarios.
Given
these
label
changes,
intermediate
term
scenarios
and
risks
should
no
longer
exist.
Refer
to
the
previous
HED
TRED
chapter
for
risk
estimates
involving
such
scenarios
(
i.
e.,
"
Fenarimol.
Revised
HED
Human
Health
Assessment
for
the
Tolerance
Reassessment
Eligibility
Decision
(
TRED)
Document.
Chemical
No.
206600.
No
MRID
#.
DP
Barcode
No.
D283429",
dated
June
7,
2002).
For
the
short
term
(
1
30
day)
incidental
oral,
dermal,
and
inhalation
risk
assessments,
a
LOAEL
of
35
mg/
kg/
day
was
selected.
This
endpoint
is
based
on
decreased
fertility
and
dystocia,
an
indicator
of
hormonal
effects,
observed
in
a
special
non
guideline
cross
breeding
reproduction/
developmental
toxicity
study
in
rats.
Because
a
NOAEL
could
not
be
identified,
and
effects
seen
at
the
lowest
dose
tested,
a
LOAEL
was
used,
and
an
additional
3x
uncertainty
factor
was
applied.
Therefore,
a
MOE
greater
than
900
does
not
exceed
HED's
level
of
concern
for
short
term
risk
assessments.
Dermal
absorption
was
estimated
to
be
5%
based
on
data
from
a
monkey
dermal
absorption
study
(
see
section
3.1
for
details).
An
acute
dietary
toxicity
endpoint
was
not
identified
by
HIARC,
and
consequently,
no
acute
risk
assessment
was
required.
21
Table
3.
Summary
of
Toxicity
Endpoints
and
Doses
for
Risk
Assessment.
EXPOSURE
SCENARIO
DOSE
(
mg/
kg/
day)
ENDPOINT
STUDY
Acute
Dietary
No
appropriate
study
for
a
single
dose
risk
assessment.
Chronic
Dietary
NOAEL
=
0.6
UF
=
100X
FQPA
=
3X
Decreased
liveborn
litter
size
in
rat
reproduction
study.
LOAEL
=
1.2
mg/
kg/
day
Rat
reproduction
MRID
#
00235175
Chronic
RfD
=
0.006
mg/
kg/
day
Chronic
PAD
=
0.002
mg/
kg/
day
Incidental
Oral,
Short
Term
LOAEL=
35
UF
=
300X
FQPA
=
3X
Decreased
fertility
and
dystocia
an
indication
of
hormonal
effects.
Special
reproduction
study
MRID
#
0084968
Incidental
Oral,
Intermediate
Term
NOAEL=
0.6
UF
=
100X
FQPA
=
3X
Decreased
liveborn
litter
size.
LOAEL
=
1.2
mg/
kg/
day
Rat
reproduction
MRID
#
00235175
Dermal,
Short
Term
Oral
LOAEL=
35
UF
=
300X
FQPA
=
3X
Decreased
fertility
and
dystocia
an
indication
of
hormonal
effects.
Special
reproduction
study
MRID
#
0084968
Dermal,
Intermediate
Term
Oral
NOAEL=
0.6
UF
=
100X
FQPA
=
3X
Decreased
liveborn
litter
size.
LOAEL
=
1.2
mg/
kg/
day
Rat
reproduction
MRID
#
00235175
Dermal,
Long
Term
Oral
NOAEL=
0.6
UF
=
100X
FQPA
=
3X
Decreased
liveborn
litter
size.
LOAEL
=
1.2
mg/
kg/
day
Rat
reproduction
MRID
#
00235175
Inhalation,
Short
Term
Oral
LOAEL
=
35
UF
=
300X
FQPA
=
3X
Decreased
fertility
and
dystocia
an
indication
of
hormonal
effects
Special
reproduction
study
MRID
#
0084968
Inhalation,
Intermediate
Term
Oral
NOAEL=
0.6
UF
=
100X
FQPA
=
3X
Decreased
liveborn
litter
size.
LOAEL
=
1.2
mg/
kg/
day
Rat
reproduction
MRID
#
00235175
Inhalation,
Long
Term
Oral
NOAEL=
0.6
UF
=
100X
FQPA
=
3X
Decreased
liveborn
litter
size.
LOAEL
=
1.2
mg/
kg/
day
Rat
reproduction
MRID
#
00235175
Because
a
toxicity
endpoint
from
an
oral
study
was
selected
for
dermal
and
inhalation
endpoints,
a
dermal
absorption
factor
of
5%
must
be
used
for
oral
to
dermal
route
to
route
exposures
and
a
100%
inhalation
absorption
factor
must
be
used
for
inhalation
exposures.
3.4
Endocrine
Disruption
The
Agency
is
required
under
the
FFDCA,
as
amended
by
FQPA,
to
develop
a
screening
program
to
determine
whether
certain
substances
(
including
all
pesticide
active
and
other
ingredients)
"
may
have
an
effect
in
humans
that
is
similar
to
an
effect
produced
by
a
naturally
occurring
estrogen,
or
other
such
endocrine
effects
as
the
Administrator
may
designate."
Following
the
recommendations
of
its
Endocrine
Disruptor
Screening
and
Testing
Advisory
Committee
(
EDSTAC),
EPA
determined
that
there
was
scientific
bases
for
including,
as
part
of
the
program,
the
androgen
and
thyroid
hormone
systems,
in
addition
to
the
estrogen
hormone
system.
EPA
also
adopted
EDSTAC's
recommendation
22
that
the
Program
include
evaluations
of
potential
effects
in
wildlife.
For
pesticide
chemicals,
EPA
will
use
FIFRA
and,
to
the
extent
that
effects
in
wildlife
may
help
determine
whether
a
substance
may
have
an
effect
in
humans,
FFDCA
authority
to
require
the
wildlife
evaluations.
As
the
science
develops
and
resources
allow,
screening
of
additional
hormone
systems
may
be
added
to
the
Endocrine
Disruptor
Screening
Program
(
EDSP).
Fenarimol
has
demonstrated
effects
on
hormonal
systems.
When
the
appropriate
screening
and/
or
testing
protocols
being
considered
under
the
Agency's
EDSP
have
been
developed,
fenarimol
may
be
subjected
to
additional
screening
and/
or
testing
to
better
characterize
effects
related
to
endocrine
disruption.
4.0
EXPOSURE
ASSESSMENT
4.1
Summary
of
Registered
Uses
Fenarimol
is
currently
registered
for
use
on
fruit
and
nut
crops
such
as
apples,
cherries,
filberts,
grapes,
pears,
and
pecans
as
well
as
on
ornamental
plants,
trees,
grasses,
and
turf.
Fenarimol
is
also
used
on
imported
bananas.
The
registration
of
fenarimol
is
being
supported
by
Gowan
Company.
The
sole
fenarimol
formulation
class
which
is
registered
for
use
on
fruit
and
nut
crops
is
an
emulsifiable
concentrate
sold
under
the
trade
name
RubiganJ,
and
this
formulation
is
typically
applied
using
ground
equipment.
HED
has
been
informed
by
SRRD
that
the
registrant
has
agreed
to
amend
their
product
labels
to
limit
applications
to
turf
to
golf
courses
and
professional
playing
fields
only.
Applications
to
residential
turf
will
not
be
permitted
on
products
labels
until
such
time
as
additional
data
are
submitted,
reviewed,
found
acceptable,
and
warrant
these
uses
to
be
reinstated
on
product
labels.
4.2
Dietary
Exposure
and
Risk
Assessment
4.2.1
Residue
Profile
The
established
permanent
and
time
limited
tolerances
for
fenarimol
are
published
in
40
CFR
§
180.421
and
are
expressed
in
two
different
ways.
Tolerances
listed
under
40
CFR
§
180.421(
a)(
1)
and
§
180.421(
b)
are
expressed
in
terms
of
residues
of
fenarimol
per
se.
Tolerances
listed
under
40
CFR
§
180.421(
a)(
2)
are
expressed
in
terms
of
the
combined
residues
of
fenarimol
and
its
metabolites
[
alpha(
2
chlorophenyl)
alpha(
4
chlorophenyl)
1,4
dihydro
5
pyrimidinemethanol(
Metabolite
B)
and
5[
2
chlorophenyl)(
4
chlorophenyl)
methyl]
3,4
dihydro
4
pyrimidinol]
(
Metabolite
C)
measured
as
the
total
of
fenarimol
and
5[
2
chlorophenyl)(
4
chlorophenyl)
methyl]
pyrimidine
(
calculated
as
fenarimol).
The
registration
requirements
for
plant
metabolism
are
fulfilled.
Acceptable
studies
depicting
the
metabolism
of
[
14C]
fenarimol
in
apples,
cherries,
and
grapes
are
available.
The
apple
and
cherry
metabolism
studies
indicate
that
the
parent
fenarimol
is
the
major
residue
component
whereas
the
grape
metabolism
study
identified
the
parent
plus
Metabolites
B
and
C
as
the
principal
residue
components.
The
Metabolism
Assessment
Review
Committee
(
MARC)
has
determined
that
for
enforcement
purposes,
the
tolerance
should
be
expressed
as
parent
only.
However,
the
dietary
assessment
for
grapes
and
bananas
should
include
the
Metabolites
B
and
C,
because
of
their
structural
similarity
to
parent
fenarimol
and
because
there
are
existing
residue
data
for
the
metabolites
on
those
commodities
(
D277692,
9/
17/
01,
D.
DREW).
Combined
residues
of
Metabolites
B
and
C
occur
on
banana
pulp
samples
at
a
range
of
0.24x
to
1.7x
that
of
parent
fenarimol,
and
on
grapes
at
a
range
of
23
N
N
OH
Cl
Cl
NH
N
OH
Cl
Cl
N
NH
Cl
Cl
OH
0.59x
to
3.3x
that
of
parent
fenarimol.
Analytical
methods
exist
for
determining
residues
of
Metabolites
B
and
C
(
measured
as
deshydroxyfenarimol)
in
plants.
The
chemical
names
and
structures
of
fenarimol
and
Metabolites
B
and
C
are
depicted
below
in
Figure
1.
Figure
1.
Chemical
Names
and
Structures
of
Fenarimol
and
Metabolites
B
and
C.
Common
Name
Chemical
Structure
Chemical
Name
Common
Name
Chemical
Structure
Chemical
Name
Common
Name
Chemical
Structure
Chemical
Name
Fenarimol
Metabolite
B
(
Compound
212746)
Metabolite
C
(
Compound
210302)
[
alpha(
2
chlorophenyl)
alpha(
4
chlorophenyl)
5
pyrimidinemethanol]
[
alpha(
2
chlorophenyl)
alpha(
4
chlorophenyl)
1,4
dihydro
5
pyrimidinemethanol]
[
5[
2
chlorophenyl)(
4
chlorophenyl
methyl]
3,4
dihydro
4
pyrimidinol]
The
qualitative
nature
of
the
residue
in
milk
and
ruminant
tissues
is
adequately
understood.
For
the
purpose
of
registration,
the
terminal
residue
of
concern
in
milk
and
ruminant
and
hog
tissues
is
fenarimol
per
se.
Wet
apple
pomace
is
the
only
animal
feed
item
associated
with
the
registered
uses
of
fenarimol.
There
are
no
hog
or
poultry
feed
items.
The
registration
requirements
for
residue
analytical
methods
are
fulfilled.
Adequate
methods
are
available
for
data
collection
and
enforcement
of
tolerances
for
residues
of
fenarimol
per
se
in/
on
plants
and
livestock.
Adequate
methods
are
also
available
for
determination
of
residues
of
fenarimol
and
Metabolites
B
and
C
in
plants
[
Pesticide
Analytical
Manual
(
PAM)
Volume
II,
Methods
I
(
AMAA
CA
R039
AB
755),
II
(
AM
AA
CA
R072
AA
755),
and
III
(
AM
AA
CA
R124
AA
755].
The
requirements
for
data
depicting
magnitude
of
the
residue
in/
on
plants
are
fulfilled
for
the
following
raw
agricultural
commodities
(
RACs):
apples,
cherries,
filberts,
grapes,
pears,
and
imported
bananas.
Overall,
a
sufficient
number
of
field
trials
were
conducted,
and
the
trials
were
conducted
using
representative
fenarimol
formulations
at
the
maximum
registered
application
rates.
In
some
cases,
residue
data
were
translated
from
closely
related
plant
groups
with
identical
use
patterns.
Adequate
processing
data
are
also
available.
Studies
indicate
that
fenarimol
per
se
concentrate
in
wet
apple
pomace
(
3.7x)
but
not
in
apple
juice
(
0.05x).
Grape
processing
studies
indicate
that
the
combined
residues
of
fenarimol
and
its
metabolites
concentrate
in
grape
juice
(
1.6x)
and
raisins
(
1.2x).
The
concentration
factors
for
grape
products
are
of
such
small
magnitude
that
tolerances
will
not
have
to
be
established
for
grape
juice
or
raisins.
24
4.2.2
Dietary
Exposure
Risk
from
Food
Sources
HED
conducts
dietary
risk
assessments
using
the
Dietary
Exposure
Evaluation
Model
(
DEEMJ
Version
7.075),
which
incorporates
consumption
data
generated
in
USDA's
Continuing
Surveys
of
Food
Intakes
by
Individuals
(
CSFII),
1989
1992.
For
chronic
dietary
risk
assessments,
the
three
day
average
of
consumption
for
each
sub
population
is
combined
with
average
residues
in
commodities
to
determine
average
exposures
in
mg/
kg/
day.
The
chronic
dietary
exposure
assessment
for
fenarimol
is
highly
refined
using
anticipated
residues
based
on
1996
1999
Food
and
Drug
Administration
(
FDA)
monitoring
data
for
apples,
bananas,
cherries,
grapes
and
pears.
Field
trial
residue
data
were
used
for
pecans
and
filberts.
Percent
crop
treated
(%
CT)
information
and
processing
factors,
where
available,
were
used
in
the
assessment.
There
were
no
PDP
monitoring
data
available
for
fenarimol.
Residues
of
fenarimol
per
se
were
nondetectable
(
below
the
method
limit
of
detection,
or
LOD)
in
all
1996
1999
FDA
monitoring
samples
of
apples,
bananas,
grapes,
and
pears
(
a
total
of
more
than
3,000
samples).
Out
of
214
cherry
samples,
three
had
detectable
residues.
Residues
of
fenarimol
per
se
were
nondetectable
(<
LOD)
in/
on
all
but
one
pecan
nut
meat
sample
from
seven
trials.
There
were
no
detectable
residues
in
filbert
samples
from
four
field
trials.
FDA
results
for
bananas
and
grapes
were
adjusted
to
account
for
potential
residues
of
Metabolites
B
and
C.
Banana
and
grape
field
trial
data
indicate
that
total
metabolites
of
fenarimol
occur
in
banana
pulp
at
a
maximum
2X
of
fenarimol
per
se,
and
in
grape
at
a
maximum
of
3x.
The
anticipated
secondary
residues
of
fenarimol
in
ruminant
tissues
(
meat,
fat
and
meat
byproducts)
are
derived
from
a
cattle
feeding
study
(
MRID
40098605,
PP#
4F3108,
F.
Boyd,
9/
20/
84).
Wet
apple
pomace
is
the
only
feedstuff
associated
with
registered
uses
of
fenarimol.
Anticipated
residues
were
all
very
low
(
all
less
than
0.003
ppm).
Milk,
eggs,
poultry
tissue
and
hog
tissue
were
not
included
in
the
dietary
assessment
because
the
Agency
has
determined
that
there
is
no
reasonable
expectation
of
finite
residues
of
fenarimol
in
these
animal
commodities,
and
is
recommending
that
established
tolerances
for
milk,
hog
tissues,
poultry
tissues,
and
eggs
be
revoked
as
per
Category
3
of
40
CFR
§
180.6(
a).
There
are
no
poultry
or
hog
feed
items
associated
with
the
registered
uses
of
fenarimol.
This
assessment
concludes
that
for
all
supported
registered
commodities,
the
chronic
risk
estimates
are
below
the
Agency's
level
of
concern
(<
100%
of
the
chronic
population
adjusted
dose,
cPAD)
for
the
general
U.
S.
population
and
all
population
subgroups
(<
1%
of
the
cPAD);
see
Table
4.
Table
4.
Results
of
Chronic
Dietary
Exposure
Analysis
Population
Subgroup
Exposure
(
mg/
kg/
day)
%
cPAD1
U.
S.
Population
(
total)
0.000000
<
1
All
Infants
(<
1
year)
0.000001
<
1
Children
1
6
years
0.000002
<
1
Children
7
12
years
0.000001
<
1
Females
13
50
0.000000
<
1
Males
13
19
0.000000
<
1
Population
Subgroup
Exposure
(
mg/
kg/
day)
%
cPAD1
25
Males
20+
years
0.000000
<
1
Seniors
55+
0.000000
<
1
1
cPAD
=
0.0006
mg/
kg/
day
4.3
Water
Exposure
Pathway
This
assessment
is
based
on
environmental
fate
studies
conducted
in
the
1970s
and
early
1980s.
The
quality
of
the
data
provided
by
these
studies
is
significantly
lower
than
currently
required.
By
current
standards
most
of
these
studies
would
not
be
considered
acceptable
and
the
results
would
not
be
considered
of
sufficient
quality
to
allow
a
reasonably
accurate
assessment
of
the
environmental
fate
of
this
compound.
Fenarimol
is
persistent
and
moderately
mobile
in
the
environment.
In
field
studies,
fenarimol
reportedly
dissipated
with
half
lives
of
three
months
to
several
years
from
soil
and
turf
surfaces
and
much
slower
when
incorporated
into
soil.
Based
on
fenarimol's
chemical
properties
it
is
likely
that
this
chemical
will
move
to
surface
water
and
groundwater,
and
it
may
accumulate
in
the
environment.
It
is
believed
to
be
stable
to
hydrolysis,
anaerobic
microbial
degradation
and
photolysis
on
soil.
It
is
degraded
very
slowly,
if
at
all,
by
aerobic
microbial
processes
with
reported
mean
aerobic
soil
metabolism
half
life
of
about
4
years.
It
is
degraded
by
photolysis
in
aqueous
solution.
The
primary
photolysis
product
is
4
chloro
2(
5
pyrimidyl)
2'
clorobenzophenone.
The
MARC
elected
not
to
exclude
this
aquatic
photolysis
degradate
in
the
drinking
water
exposure
assessment
because:
1)
its
potential
to
occur
in
surface
water;
and,
2)
the
lack
of
data
to
determine
whether
or
not
it
is
of
toxicological
concern.
Tier
I
surface
water
and
ground
water
Estimated
Environmental
Concentrations
(
EECs)
for
fenarimol
were
calculated
using
FIRST
(
surface
water)
and
SCI
GROW
(
groundwater)
modeling
of
application
to
turf.
FIRST
is
a
first
tier
screening
model
designed
as
a
coarse
screen
to
estimate
the
pesticide
concentrations
found
in
an
`
Index
Reservoir'
located
in
Shipman,
Illinois
for
use
in
environmental
risk
assessments
for
drinking
water.
As
such,
it
provides
high
end
estimates
of
the
concentrations
of
a
pesticide
in
drinking
water
that
might
be
derived
from
surface
water.
This
first
level
tier
is
designed
as
a
coarse
screen
and
estimates
concentrations
from
only
a
few
basic
chemical
parameters
and
pesticide
label
application
information.
The
FIRST
program
is
designed
to
mimic
a
more
complex
simulation
such
as
using
the
linked
PRZM
and
EXAMS
models,
but
requires
less
time
and
effort
to
complete.
If
a
risk
assessment
performed
using
FIRST
output
does
not
exceed
the
level
of
concern,
then
one
can
be
reasonably
confident
that
the
acute
risk
will
not
be
exceeded.
However,
for
stable
chemicals
with
long
environmental
half
lives
FIRST
may
significantly
underestimate
long
term
EECs.
SCI
GROW
provides
a
ground
water
screening
exposure
value
to
be
used
in
determining
the
potential
risk
to
human
health
from
drinking
water
contaminated
with
the
pesticide.
SCI
GROW
estimates
EEC
values
in
shallow
ground
water
for
only
a
single
season
and
so
is
much
less
useful
in
estimating
EEC
values
for
stable
compounds
that
may
persist
in
the
environment.
The
EEC
value
calculated
using
SCI
GROW
should
therefore
be
used
with
caution
since
it
probably
underestimates
possible
ground
water
concentrations.
Since
the
last
version
of
this
HED
TRED
(
June
7,
2002),
the
Environmental
Fate
and
Effects
Division
(
EFED)
received
additional
information
on
the
aquatic
photo
degradate
(
i.
e.
4
chloro
2(
5
pyrimidyl)
2'
clorobenzophenone)
and
has
subsequently
revised
the
drinking
water
assessment.
The
26
updated
drinking
water
assessment
(
N.
Birchfield;
July
31,
2002;
D284487)
was
revised
to
include
fenarimol
and
its
aquatic
photodegradates.
The
previous
drinking
water
assessment
(
L.
Liebelo,
August
6,
2001;
D276622)
did
not
attempt
to
account
for
possible
photo
degradates
of
concern.
In
the
new
updated
drinking
water
assessment,
the
model
inputs
were
adjusted
so
that
aquatic
concentrations
were
estimated
assuming
no
aqueous
photolysis,
which
appears
to
be
fenarimol's
most
significant
route
of
dissipation
in
the
environment.
Minor
model
input
corrections
were
also
made
to
the
application
rate
and
interval.
The
result
provides
a
screening
level
estimate
of
combined
concentrations
of
fenarimol
and
its
aquatic
degradates
that
is
conservative
and
that
does
not
underestimate
exposure.
The
EECs
for
surface
and
ground
water
are
summarized
in
Table
5.
As
a
result
of
this
reassessment,
the
surface
water
acute
EEC
increased
from
242
to
261
g/
L,
and
the
chronic
EECs
increased
from
59
to
84
g/
L
for
surface
water,
and
from
14
to
16
g/
L
for
ground
water.
These
surface
water
EEC
values
represent
the
maximum
surface
water
concentration
(
acute
EEC),
and
the
mean
yearly
concentration
(
chronic
EEC),
respectively,
resulting
from
fenarimol
use
on
turf.
The
ground
water
screening
concentration,
calculated
using
SCI
GROW,
represents
a
90
day
average
concentration
value.
This
value
should
be
used
for
both
chronic
and
acute
ground
water
estimates.
Although,
there
is
still
some
uncertainty
as
to
the
identity,
fate,
and
behavior
of
the
photolysis
degradates
of
fenarimol,
data
will
be
required
to
address
this
uncertainty.
Table
5.
Modeling
Results
(
Estimated
Environmental
Concentrations
(
EECs))
for
Application
of
Fenarimol
to
Turf.
Model
Concentrationa
FIRST
Peak
Day
(
Acute)
Surface
Water
261
g/
L
FIRST
Annual
Average
(
Chronic)
Surface
Water
84
g/
L
SCI
GROW
Ground
Water
Value
16
g/
L
a
EECs
are
for
parent
fenarimol
and
the
aqueous
photolytic
degradate.
4.4
Residential
Exposure
Potential
residential
exposures
were
possible
as
a
result
of
applications
of
fenarimol
to
residential
lawns
or
turf
by
residents
and
by
professional
lawn
care
operators
(
LCOs).
However,
as
mentioned
above,
HED
has
been
informed
by
SRRD
that
the
registrant
has
agreed
to
amend
their
product
labels
to
limit
applications
to
turf
to
golf
courses
and
professional
playing
fields
only.
Applications
to
residential
turf
will
not
be
permitted
on
products
labels
until
such
time
as
additional
data
are
submitted,
reviewed,
found
acceptable,
and
warrant
these
uses
to
be
reinstated
on
product
labels.
Therefore,
the
only
residential/
recreational
exposure
scenario
to
evaluate
is
adult
golfers.
These
residential/
recreational
exposures
have
been
estimated
based
on
label
application
frequency,
and
the
persistence
of
fenarimol.
Most
assumptions
for
risk
estimation
were
based
on
the
Residential
SOPs.
Chemical
specific
data
from
a
turf
transferable
residue
(
TTR)
study
were
available,
but
were
not
used
to
estimate
the
short
term
postapplication
risk
to
golfers,
because
of
several
limitations
of
the
day
zero
TTR
data.
As
a
result
of
uses
on
golf
courses
and
professional
playing
fields,
the
HED
has
concerns
for
potential
exposures
to
adults.
Application
and
subsequent
exposure
in
residential
settings
for
the
use
sites
other
than
turf
(
i.
e.
ornamentals,
roses,
grapes,
apples,
pears,
cherries,
and
pecans)
is
considered
unlikely.
Dow
AgroSciences,
the
previous
registrant,
has
asserted
to
HED
that
product
for
these
use
sites
is
intended
for
and
used
only
in
commercial
operations.
Product
packaging
and
label
language
suggest
27
that
applications
in
residential
settings
would
not
occur.
Label
language
restrictions
include
equipment
requirements
such
as
personal
protective
equipment
(
PPE)
requirements,
worker
protection
standard
(
WPS)
requirements,
restrictions
for
use
by
PCOs,
and
application
methods
that
would
never
occur
in
residential
settings.
4.4.1
Home
Uses
4.4.1.1
Handler
Exposure
Current
product
labels
indicate
that
residential
handler
exposure
could
occur
from
handling
the
granular
fenarimol
product.
However,
HED
has
been
informed
by
SRRD
that
the
registrant
has
agreed
to
amend
their
product
labels
to
prohibit
handling
(
i.
e.
mixing,
loading
or
applying)
of
fenarimol
by
residents.
Therefore,
residential
handler
exposure
scenarios
should
no
longer
exist.
Refer
to
the
previous
HED
TRED
chapter
for
risk
estimates
involving
such
scenarios
(
i.
e.,
"
Fenarimol.
Revised
HED
Human
Health
Assessment
for
the
Tolerance
Reassessment
Eligibility
Decision
(
TRED)
Document.
Chemical
No.
206600.
No
MRID
#.
DP
Barcode
No.
D283429",
dated
June
7,
2002).
4.4.1.2
Postapplication
Exposure
Current
product
labels
indicate
that
several
post
application
exposure
scenarios
following
application
to
turf
are
anticipated.
However,
since
the
registrant
has
agreed
to
amend
their
product
labels
to
prohibit
use
of
fenarimol
in
residential
settings
and
to
increase
the
re
application
interval
to
30
days,
then
the
only
remaining
postapplication
residential/
recreational
exposure
scenario
to
evaluate
is
shortterm
exposure
to
adult
golfers.
The
short
term
postapplication
dermal
exposure
and
risk
estimates
for
adult
golfers
are
presented
in
Table
6.
Margins
of
Exposure
(
MOEs)
greater
than
900
do
not
exceed
HED's
level
of
concern.
For
adult
golfers,
a
MOE
of
14,000
is
estimated
for
short
term
postapplication
dermal
exposure,
and
does
not
exceed
HED's
level
of
concern.
Table
6:
Residential
Postapplication
Activities
on
Treated
Turf:
Dermal
Exposure
and
Non
Cancer
Risk
Estimates
Short
term
Risk
Estimates
at
DAT
0
Activity
DAT0
TTR
(
g/
cm2)
(
a)
Transfer
Coefficient
(
cm2/
hr)
(
b)
Dermal
Dose
(
mg/
kg/
day)
(
c)
MOE
(
d)
golf
course
reentry
by
adults
1.53
500
0.0026
14,000
a
TTR
source:
Standard
Operating
Procedures
(
SOPs)
for
Residential
Exposure
Assessments,
SOP
2.2:
Postapplication
dermal
potential
dose
from
pesticide
residues
on
turf.
DAT
0
residue
values
were
used
for
the
short
term
assessments
at
day
0
after
application.
TTR
=
AR
x
F
x
(
1
D)
t
x
CF1
x
Cf2,
where
AR
=
application
rate
(
lbs
a.
i./
acre),
F
=
fraction
of
a.
i.
retained
on
foliage
(
unitless),
D
=
fraction
of
residue
that
dissipates
daily
(
unitless),
t
=
postapplication
day
on
which
exposure
is
being
assessed,
CF1
=
weight
unit
conversion
factor
to
convert
the
lbs
a.
i.
in
the
application
rate
to
g
for
the
DFR
value
(
4.54E8
g/
lb),
and
CF2
=
area
unit
conversion
factor
to
convert
the
surface
area
units
(
ft2)
in
the
application
rate
to
cm2
for
the
DFR
value
(
24.7E
9
acre/
cm2);
e.
g.
TTR
at
DAT
0
=
2.73
lbs
a.
i./
acre
x
0.05
x
4.54E8
g/
lb
x
24.7E
9
acre/
cm2
=
1.53
g/
cm2.
b
Transfer
coefficient
from
the
Residential
SOP's
(
02/
01).
c
Dermal
Dose
=
TTR
(
g/
cm2)
x
TC
(
cm2/
hr)
x
conversion
factor
(
1
mg/
1,000
g)
x
exposure
time
(
4
hrs
golfing)
x
Dermal
Absorption
Factor
(
5/
100)/
body
weight
(
60
kg
adult).
Short
term
MOEs
were
calculated
using
DAT
0
residue
values.
28
d
MOE
=
LOAEL
(
35
mg/
kg/
day;
based
on
a
oral
study)
/
dermal
dose;
Note:
Target
MOE
is
3000
or
greater,
since
a
NOAEL
was
not
established
and
a
LOAEL
is
used.
TTR
=
turf
transferable
residue
DAT
=
days
after
treatment
Uncertainties
Residential
SOPs
were
utilized
to
estimate
initial
residues
(
i.
e.
DAT
0
residues)
based
on
application
rate
and
to
estimate
contact
rates
with
turf.
Chemical
specific
data
from
a
turf
transferable
residue
(
TTR)
study
(
MRID
44690801)
were
available.
However,
these
TTR
data
were
found
to
be
generally
unacceptable
for
use
in
postapplication
exposure
assessment.
These
data
had
limitations,
as
follows:
1)
the
sampling
period
was
not
sufficiently
long
enough
to
adequately
characterize
dissipation;
2)
only
duplicate
samples
were
collected
at
each
sampling
interval,
not
the
Agency
recommended
triplicate
sampling;
and
3)
the
day
0
(
DAT
0)
data
from
the
California
site
were
inconsistent
with
data
from
the
other
two
sites.
Therefore,
based
on
the
weight
of
evidence
these
data
were
discounted.
A
dissipation
rate
of
8%
(
daily)
was
derived
from
these
data.
Also,
the
data
show
that
6.1%,
0.85%,
and
0.59%
(
for
CA,
IN
&
MS,
respectively)
of
the
applied
fenarimol
was
detected
on
DAT
0.
By
comparison,
the
Agency's
SOP
uses
a
transfer
efficiency
(
percent
of
application
rate)
of
5%.
Therefore,
due
to
the
variability
of
the
study
transfer
efficiency
data,
the
poor
quality
of
the
study
itself,
and
because
no
transfer
coefficient
exists
for
the
California
roller
method
that
was
used
in
this
study,
the
HED
will
use
the
5%
transfer
efficiency
rate
for
risk
assessment
purposes.
However,
the
HED
notes
that
the
6.1%
transfer
efficiency
rate
measured
from
the
CA
site
may
be
an
outlier,
since
the
DAT
1
data
(
residues
detected
one
day
after
application)
from
the
CA
site
were
an
order
of
magnitude
lower,
and
the
DAT
0
and
DAT
1
data
from
the
IN
and
MS
sites
were
considerably
lower.
Therefore,
use
of
the
5%
transfer
efficiency
rate
may
be
a
conservative
assumption.
Better
data
may
indicate
a
value
closer
to
1%,
which
would
increase
the
MOEs
by
five
fold.
The
exposure
estimates
generated
for
the
golfing
turf
use
using
the
Draft
SOPs
is
based
on
some
upper
percentile
assumptions
(
i.
e.,
duration
of
exposure
and
maximum
application
rate
for
this
shortterm
assessment)
and
is
considered
to
be
representative
of
high
end
exposures.
The
uncertainties
associated
with
this
assessment
stem
from
the
use
of
an
assumed
amount
of
pesticide
retained
on
turf,
and
assumptions
regarding
the
transfer
of
fenarimol
residues.
The
turf
risk
estimate
is
believed
to
be
a
reasonable
and
protective
estimate,
that
is
based
on
Agency
residential
SOPs.
Therefore,
the
level
of
confidence
is
fairly
high,
and
does
not
under
estimate
risk.
HED
assumes
that
the
general
public's
exposure
on
a
golf
course
will
not
be
mitigated
by
use
of
personal
protective
gear.
Therefore,
only
administrative
controls
(
e.
g.,
formulation
changes
or
use
rate
reductions)
are
feasible
methods
of
risk
reduction.
Mitigating
circumstances
for
residential
exposure
to
fenarimol
residues
may
include
the
watering
in
of
the
granular
formulation
to
turf.
This
instruction,
however,
does
not
prevent
contact
with
treated
turf
prior
to
watering
in.
The
current
granular
label
(
EPA
Reg.
No.
228
298)
recommends,
but
does
not
require
watering
in.
The
soluble
concentrate
label
(
EPA
Reg.
No.
62719
142)
does
not
mention
watering
in.
Therefore,
label
language
should
be
strengthened
to
ensure
that
watering
in
occurs
immediately
after
application.
When
fenarimol
is
applied
to
stadium
or
professional
athletic
fields,
applicators
should
water
in
product
immediately
after
application,
or
do
not
enter
or
allow
others
to
enter
treated
area
for
24
hours
after
application.
If
product
is
watered
in
after
treatment,
do
not
enter
or
allow
other
persons
to
enter
until
area
has
dried.
4.4.2
Spray
Drift
29
Spray
drift
is
always
a
potential
source
of
exposure
to
the
public
near
spraying
operations.
This
is
particularly
the
case
with
aerial
application,
but,
to
a
lesser
extent,
could
also
be
a
potential
source
of
exposure
from
groundboom
application
methods.
The
Agency
has
been
working
with
the
Spray
Drift
Task
Force,
EPA
Regional
Offices
and
State
Lead
Agencies
for
pesticide
regulation
and
other
parties
to
develop
the
best
spray
drift
management
practices.
The
Agency
is
now
requiring
interim
mitigation
measures
for
aerial
applications
that
must
be
placed
on
product
labels/
labeling.
The
Agency
has
completed
its
evaluation
of
the
new
data
base
submitted
by
the
Spray
Drift
Task
Force,
a
membership
of
U.
S.
pesticide
registrants,
and
is
developing
a
policy
on
how
to
appropriately
apply
the
data
and
the
AgDRIFT
computer
model
to
its
risk
assessments
for
pesticides
applied
by
air,
orchard
airblast
and
ground
hydraulic
methods.
After
the
policy
is
in
place,
the
Agency
may
impose
further
refinements
in
spray
drift
management
practices
to
reduce
off
target
drift
and
risks
associated
with
aerial
as
well
as
other
application
types
where
appropriate.
5.0
AGGREGATE
RISK
ASSESSMENT
AND
RISK
CHARACTERIZATION
5.1
Acute
Aggregate
Risk
Assessment
Because
an
acute
toxicity
endpoint
was
not
identified
by
HIARC,
an
acute
aggregate
risk
assessment
is
not
required.
5.2
Short
and
Intermediate
Term
Aggregate
Risk
Assessment
Based
on
agreements
with
the
registrant
regarding
amendments
to
product
labels
as
described
above,
HED
does
not
anticipate
any
intermediate
term
exposure,
nor
any
residential
handler
or
postapplication
exposures,
other
than
those
from
uses
on
golf
course
and
professional
playing
fields.
Short
term
dermal
postapplication
exposures
for
adults
golfing
were
combined
with
average
dietary
(
food
&
water)
exposures
in
a
short
term
aggregate
risk
assessment.
This
aggregate
risk
estimate
did
not
exceed
the
Agency's
level
of
concern.
The
exposure
from
food
is
insignificant
for
adults;
therefore,
the
aggregate
risk
estimates
include
only
dermal
and
water
exposures.
Table
7
presents
the
aggregate
risk
estimates
for
adult
males
and
females,
calculated
using
HED
SOP
99.5.
The
shortterm
DWLOCs
for
adults
are
well
above
the
estimated
EECs
for
ground
and
surface
water,
and
indicate
that
combined
short
term
dietary
(
food
&
water)
and
postapplication
dermal
exposures
do
not
exceed
the
Agency's
level
of
concern.
30
Table
7.
Short
Term
Aggregate
Risk
and
DWLOC
Calculations
(
Oral/
Dermal
Endpoints
and
NOAELs
the
Same)
Population
Short
Term
Scenario
NOAEL
mg/
kg/
day
Target
MOE1
Max
Exposure2
mg/
kg/
day
Average
Food
Exposure
mg/
kg/
day
Residential
Exposure3
mg/
kg/
day
Aggregate
MOE
(
food
and
residential)
4
Max
Water
Exposure5
mg/
kg/
day
Ground
Water
EEC6
(
g/
L)
Surface
Water
EEC6
(
g/
L)
Short
Term
DWLOC7
(
g/
L)
Adult
Male
35
900
0.0388
0.0
0.0026
13460
0.0362
16
84
1267
Adult
Female
35
900
0.0388
0.0
0.0026
13460
0.0362
16
84
1086
1
Target
MOE
=
10x
uncertainty
factor
(
UF)
for
intra
species
variability,
a
10x
UF
for
inter
species
extrapolation,
a
3x
UF
for
lack
of
a
NOAEL
in
the
study
used
as
the
basis
of
the
endpoint,
and
an
FQPA
Safety
Factor
of
3x
2
Maximum
Exposure
(
mg/
kg/
day)
=
NOAEL/
Target
MOE
3
Residential
Exposure
=
Dermal
Exposure
for
Adults
Golfing
4
Aggregate
MOE
=
[
NOAEL
÷
(
Avg
Food
Exposure
+
Residential
Exposure)]
5
Maximum
Water
Exposure
(
mg/
kg/
day)
=
Target
Maximum
Exposure
(
Food
Exposure
+
Residential
Exposure)
6
The
crop
producing
the
highest
level
was
used.
7
DWLOC
(
g/
L)
=
[
maximum
water
exposure
(
mg/
kg/
day)
x
body
weight
(
kg)]
Male
body
weight
=
70
kg;
Female
body
weight
=
60
kg;
water
consumption
=
2
L
[
water
consumption
(
L)
x
10
3
mg/
g]
31
5.3
Chronic
Aggregate
Risk
Assessment
5.3.1
Aggregate
Chronic
Risk
Assessment
The
aggregate
chronic
risk
assessment
for
fenarimol
considers
both
chronic
food
and
drinking
water
exposure
to
fenarimol.
Chronic
exposure
to
residues
of
fenarimol
in/
on
food
does
not
exceed
HED's
level
of
concern.
However,
the
EEC
for
surface
water
exceeds
the
chronic
DWLOCs
for
all
population
subgroups
(
see
below),
indicating
a
potential
concern
for
exposure
through
drinking
water.
Tier
I
EECs
were
calculated
for
the
turf
use
of
fenarimol.
A
Tier
II
model
is
not
available
for
turf.
5.3.2
Chronic
DWLOC
Calculations
HED
has
calculated
drinking
water
levels
of
comparison
(
DWLOCs)
for
chronic
exposure
to
fenarimol
in
surface
and
ground
water
which
are
presented
in
Table
8.
The
DWLOC
chronic
is
the
concentration
in
drinking
water
as
a
part
of
the
aggregate
chronic
exposure
that
occupies
no
more
than
100%
of
the
chronic
PAD.
To
calculate
the
DWLOC
for
chronic
exposure
relative
to
a
chronic
toxicity
endpoint,
the
chronic
dietary
food
exposure
(
from
DEEMJ)
was
subtracted
from
the
chronic
PAD
to
obtain
the
acceptable
chronic
exposure
to
fenarimol
in
drinking
water.
DWLOCs
were
then
calculated
using
default
body
weights
and
drinking
water
consumption
figures.
Assumptions
used
in
calculating
the
DWLOCs
include
70
kg
body
weight
for
the
U.
S.
population,
60
kg
body
weight
for
adult
females,
10
kg
body
weight
for
children,
two
liters
of
water
consumption
per
day
for
adults,
and
one
liter
consumption
for
children.
To
estimate
the
potential
risks
associated
with
chronic
exposure
to
fenarimol
in
drinking
water,
HED
compared
estimated
environmental
concentrations
(
EECs)
of
fenarimol
in
surface
and
ground
water
to
chronic
DWLOCs.
If
EECs
are
greater
than
DWLOCs,
then
risk
estimates
exceed
HED's
levels
of
concern.
The
surface
water
EECs
represent
annual
average
concentrations
of
fenarimol,
and
the
ground
water
EECs
represent
90
day
average
concentrations
of
fenarimol.
The
EECs
are
based
on
tier
1
models
(
FIRST
for
surface
water;
SCI
GROW
for
ground
water)
for
a
turf
use
scenario
with
maximum
application
rates.
Initially,
the
drinking
water
assessment
did
not
include
the
water
degradate
of
concern,
because
the
environmental
fate
database
is
incomplete
for
the
aquatic
photodegradate
of
fenarimol,
4
chloro
2(
5
pyrimidyl)
2'
chlorobenzophenone.
Consequently,
the
drinking
water
assessment
may
underestimate
exposure.
Recently,
the
Environmental
Fate
and
Effects
Division
(
EFED)
received
additional
information
on
the
aquatic
photo
degradate
and
revised
the
drinking
water
assessment.
The
updated
drinking
water
assessment
(
July
31,
2002;
D284487)
was
revised
to
include
fenarimol
and
its
aquatic
photodegradates.
The
model
inputs
were
adjusted
so
that
aquatic
concentrations
were
estimated
assuming
no
aqueous
photolysis,
which
appears
to
be
fenarimol's
most
significant
route
of
dissipation
in
the
environment.
Minor
model
input
corrections
were
also
made
to
the
application
rate
and
interval.
The
result
provides
a
screening
level
estimate
of
combined
concentrations
of
fenarimol
and
its
aquatic
degradates
that
is
conservative
and
that
does
not
underestimate
exposure.
As
a
result
of
this
reassessment
the
chronic
EECs
increased
from
59
to
84
g/
L
for
surface
water,
and
from
14
to
16
g/
L
for
ground
water.
Although,
there
is
still
some
uncertainty
as
to
the
identity,
fate,
and
behavior
of
the
photolysis
degradates
of
fenarimol,
data
will
be
required
to
address
this
uncertainty.
32
Table
8.
Fenarimol
Summary
of
Chronic
DWLOC
Calculations
Population
Subgroup
cPAD
(
mg/
kg/
day
)
Food
Exposure
(
mg/
kg/
day)
Available
Water
Exposure
(
mg/
kg/
day)
Chronic
DWLOC
(
g/
L)
EFED
Generated
EECs
(
Chronic)
Surface
Water
(
FIRST)
(
g/
L)
Ground
Water
(
SCI
GROW)
(
g/
L)
U.
S.
Populationa
0.002
0.000000
0.002
70
84
16
Females
13
50
yrs
0.000000
0.002
60
Children
1
6
yrs
b
0.000002
0.000598
20
All
Infants
0.000001
0.000599
20
EEC
=
Estimated
Environmental
Concentrations
for
fenarimol
and
its
aquatic
photodegradates.
NOAEL
(
No
Observable
Adverse
Effect
Level)
=
0.6
mg/
kg/
day
UF
(
Uncertainty
Factor)
=
100
cRfD
(
Chronic
Reference
Dose)
=
NOAEL
=
0.006
mg/
kg/
day
UF
FQPA
SF
(
Food
Quality
Protection
Act
Safety
Factor)
=
3
cPAD
=
Chronic
Population
Adjusted
Dose
=
cRfD
=
0.002
mg/
kg/
day
FQPA
SF
DWLOCchronic
=
water
exposure
X
body
weight
(
where
water
exposure
=
cPAD
average
food
exposure)
Liters
of
water/
day
X10
3
Body
weight
=
70
kg
for
U.
S.
Population,
60
kg
for
females,
10
kg
for
infants
and
children
Consumption
=
2L/
day
for
Adults
and
1L/
day
for
infants
and
children
a
Also
represents
Males
13
19
years,
Males
20+
years,
and
Seniors
55+
b
Also
represents
Children
7
12
years
old.
The
EEC
for
ground
water
is
less
than
all
DWLOCs;
therefore,
there
is
no
concern
for
aggregate
chronic
exposure
to
fenarimol
and
its
degradates
from
food
and
ground
water.
The
EEC
for
surface
water
is
greater
than
all
DWLOCs;
therefore,
there
is
a
potential
concern
for
aggregate
chronic
exposures
to
fenarimol
from
food
and
surface
water.
However,
the
estimated
EEC
for
surface
water
is
a
very
conservative
estimate.
It
represents
the
1
in
10
year
mean
yearly
surface
water
concentration.
EFED's
surface
water
modeling
for
drinking
water
uses
a
default
percent
cropped
area
factor
(
PCA)
for
turf,
which
represents
the
fraction
of
the
watershed
that
is
cropped
and
treated
with
the
pesticide
being
modeled.
In
the
absence
of
a
crop
specific
PCA
factor,
a
default
PCA
of
0.87
is
used.
The
0.87
factor
represents
the
maximum
fraction
of
a
watershed
in
the
US
that
is
agriculturally
cropped.
This
default
PCA
was
used
for
fenarimol
modeling
on
turf.
EFED
is
currently
attempting
to
develop
PCA
factors
specific
for
turf
scenarios,
and
recognizes
that
it
is
unlikely
that
87%
of
a
watershed
used
for
drinking
water
would
be
grown
to
turf
and
treated
with
fenarimol
at
the
maximum
rate
allowed
only
for
turf
applications.
The
default
PCA
factor
assumed
and
used
in
fenarimol
modeling
is
most
likely
overestimated
and
adds
to
the
conservatism
of
the
assessment.
Given
the
relatively
low
usage
of
fenarimol
across
the
country
it
is
highly
unlikely
that
the
amount
applied
to
the
watershed
in
the
model
will
be
concentrated
in
any
real
watershed
used
to
derive
drinking
water.
33
In
summary,
the
surface
water
EEC
is
not
likely
to
underestimate
exposure
to
fenarimol
and
its
degradates
based
on
the
conservative
inputs
to
the
model
(
i.
e.,
default
PCA,
no
decay
via
the
major
degradation
pathway,
and
the
concentrated
application
scenario
modeled
is
unlikely
to
occur
in
a
real
watershed
where
drinking
water
is
derived).
The
uncertainties
related
to
the
aqueous
photoproducts
would
likely
be
addressed
through
completion
of
a
satisfactory
guideline
aqueous
photolysis
study
(
Guidelines
161
2,
835.2240).
Other
uncertainties
would
likely
be
addressed
through
the
satisfactory
completion
of
other
outstanding
guideline
studies;
as
detailed
by
EFED.
6.0
Cumulative
Exposure
To
Substances
with
Common
Mechanism
of
Toxicity.
The
Food
Quality
Protection
Act
(
1996)
stipulates
that
when
determining
the
safety
of
a
pesticide
chemical,
EPA
shall
base
its
assessment
of
the
risk
posed
by
the
chemical
on,
among
other
things,
available
information
concerning
the
cumulative
effects
to
human
health
that
may
result
from
dietary,
residential,
or
other
non
occupational
exposure
to
other
substances
that
have
a
common
mechanism
of
toxicity.
The
reason
for
consideration
of
other
substances
is
due
to
the
possibility
that
low
level
exposures
to
multiple
chemical
substances
that
cause
a
common
toxic
effect
by
a
common
mechanism
could
lead
to
the
same
adverse
health
effect
as
would
a
higher
level
of
exposure
to
any
of
the
other
substances
individually.
A
person
exposed
to
a
pesticide
at
a
level
that
is
considered
safe
may
in
fact
experience
harm
if
that
person
is
also
exposed
to
other
substances
that
cause
a
common
toxic
effect
by
a
mechanism
common
with
that
of
the
subject
pesticide,
even
if
the
individual
exposure
levels
to
the
other
substances
are
also
considered
safe.
HED
did
not
perform
a
cumulative
risk
assessment
as
part
of
this
risk
assessment
for
fenarimol
because
HED
has
not
yet
initiated
a
review
to
determine
if
there
are
any
other
chemical
substances
that
have
a
mechanism
of
toxicity
common
with
that
of
fenarimol.
For
purposes
of
this
tolerance
reassessment
review,
EPA
has
assumed
that
fenarimol
does
not
have
a
common
mechanism
of
toxicity
with
other
substances.
7.0
TOLERANCE
REASSESSMENT
RECOMMENDATIONS
7.1
Tolerance
Reassessment
Recommendation
Table
9
summarizes
the
tolerance
reassessment
for
fenarimol.
Table
9.
Reassessed
fenarimol
tolerances.
Commodity
Established
Tolerance
(
ppm)
Reassessed
Tolerance
(
ppm)
Comment
[
Correct
Commodity
Definition]
Tolerance
Listed
Under
40
CFR
§
180.421(
a)(
1)
Apple
pomace
(
wet
and
dry)
2.0
0.3
The
available
data
indicate
that
the
tolerance
for
wet
apple
pomace
should
be
reduced.
Dry
apple
pomace
is
no
longer
considered
a
significant
livestock
feed
item.
[
Apple,
wet
pomace]
Apples
0.1
0.1
[
Apple]
Cattle,
fat
0.1
0.01
Cattle,
meat
0.01
0.01
Cattle,
mbyp
0.01
0.05
[
Cattle,
meat
byproducts,
except
kidney]
Commodity
Established
Tolerance
(
ppm)
Reassessed
Tolerance
(
ppm)
Comment
[
Correct
Commodity
Definition]
34
Cattle,
kidney
0.1
0.01
Cattle,
liver
0.1
Revoke
[
included
in
meat
byproducts]
Eggs
0.01
Revoke
There
are
no
poultry
feed
items
associated
with
presently
registered
uses.
Goat,
fat
0.1
0.01
Goat,
meat
0.01
0.01
Goat,
mbyp
0.01
0.05
[
Goat,
meat
byproducts,
except
kidney]
Goat,
kidney
0.1
0.01
Goat,
liver
0.1
Revoke
[
included
in
meat
byproducts]
Hog,
fat
0.1
Revoke
There
are
no
hog
feed
items
associated
with
presently
registered
uses.
Hog,
meat
0.01
Revoke
Hog,
mbyp
0.01
Revoke
Hog,
kidney
0.1
Revoke
Hog,
liver
0.1
Revoke
Horse,
fat
0.1
0.01
Horse,
meat
0.01
0.01
Horse,
mbyp
0.01
0.05
[
Horse,
meat
byproducts,
except
kidney]
Horse,
liver
0.1
Revoke
[
included
in
meat
byproducts]
Horse,
kidney
0.1
0.01
Milk
0.003
Revoke
Category
3
of
40
CFR
§
180.6(
a)
Pears
0.1
0.1
[
Pear]
Pecans
0.1
0.02
[
Pecan]
Poultry,
fat
0.01
Revoke
There
are
no
poultry
feed
items
associated
with
presently
registered
uses.
Poultry,
meat
0.01
Revoke
Poultry,
mbyp
0.01
Revoke
Sheep,
fat
0.1
0.01
Sheep,
meat
0.01
0.01
Sheep,
mbyp
0.01
0.05
[
Sheep,
meat
byproducts,
except
kidney]
Sheep,
kidney
0.1
0.01
Sheep,
liver
0.1
Revoke
[
included
in
meat
byproducts]
Tolerance
Listed
Under
40
CFR
§
180.421(
a)(
2)
Bananas
0.5
(
Not
more
than
0.25
ppm
shall
be
present
in
the
pulp
after
peel
is
removed)
0.25
[
Banana]
Cherries
1.0
1.0
[
Cherry]
Commodity
Established
Tolerance
(
ppm)
Reassessed
Tolerance
(
ppm)
Comment
[
Correct
Commodity
Definition]
35
Grape
juice
0.6
Revoke
Not
required
based
on
reexamination
of
available
grape
processing
data.
Grape
pomace
(
wet
and
dry)
2.0
Revoke
No
longer
considered
a
significant
livestock
feed
item.
Grapes
0.2
0.1
[
Grape]
Raisin
waste
3.0
Revoke
No
longer
considered
a
significant
livestock
feed
item.
Raisins
0.6
Revoke
Not
required
based
on
reexamination
of
available
grape
processing
data.
Tolerance
Listed
Under
40
CFR
§
180.421(
b)
Filberts
0.02
Revoke
(
expired)
Expiration/
revocation
date
of
12/
31/
98
*
Field
trial
data
support
a
0.02
ppm
tolerance
Hops
5
Revoke
(
expired)
Expiration/
revocation
date
of
12/
31/
98
7.2
Codex/
International
Harmonization
The
Codex
Alimentarius
Commission
has
established
several
maximum
residue
limits
(
MRLs)
for
residues
of
fenarimol
in/
on
various
raw
agricultural
and
processed
commodities.
The
Codex
MRLs
are
expressed
in
terms
of
fenarimol
per
se.
A
numerical
comparison
of
the
Codex
MRLs
and
the
corresponding
reassessed
U.
S.
tolerances
is
presented
in
Table
10.
Table
10
shows
that
except
for
cattle
liver,
cherries,
and
pecans,
the
U.
S.
tolerances
and
Codex
MRLs
are
not
in
harmony
with
respect
to
numerical
levels.
Table
10.
Codex
MRLs
and
applicable
U.
S.
tolerances
for
fenarimol.
Recommendations
are
based
on
conclusions
following
reassessment
of
U.
S.
tolerances.
Codex
Reassessed
U.
S.
Tolerance,
ppm
Recommendation
And
Comments
Commodity,
As
Defined
MRL
1
(
mg/
kg)
Apple
pomace,
dry
5
wet
apple
pomace
=
0.3
Dry
apple
pomace
is
no
longer
considered
a
significant
livestock
feed
item.
Artichoke
globe
0.1
Banana
0.2
0.25
Cattle
kidney
0.02
(*)
0.01
(*)
Cattle
liver
0.05
Revoke
covered
by
tolerance
for
meat
byproducts
Cattle
meat
0.02
(*)
0.01
(*)
Cherries
1
1
Dried
grapes
(
currants,
raisins
and
sultanas)
0.2
Revoke
Grapes
0.3
0.1
Codex
Reassessed
U.
S.
Tolerance,
ppm
Recommendation
And
Comments
Commodity,
As
Defined
MRL
1
(
mg/
kg)
36
Hops,
dry
5
Melons,
except
watermelon
0.05
Peach
0.5
Pecan
0.02
(*)
0.02
(*)
Peppers,
sweet
0.5
Pome
fruits
0.3
apple/
pear
=
0.1
Strawberry
1
1
All
MRLs
are
at
CXL
step.
An
asterisk
(*)
signifies
that
the
MRL
or
US
tolerance
was
established
at
or
about
the
limit
of
detection.
8.0
DATA
NEEDS
Toxicology:
A
primary
dermal
irritation
study
(
870.2400);
a
28
day
subchronic
inhalation
study
(
870.3465);
and
a
special
developmental
toxicity
study
(
870.6300).
The
special
developmental
toxicity
study
being
required
must
include
a
special
protocol
that
assesses
potential
hormonal
effects.
Product
and
Residue
Chemistry:
Additional
data
are
required
concerning
enforcement
analytical
methods,
stability,
storage
stability,
pH,
UV/
Visible
absorption,
density,
octanol/
water
partition
coefficient,
and
solubility
(
OPPTS
830.1800,
6313,
6317,
7000,
7050,
7300,
7550,
and
7840)
of
the
T/
TGAI.
Storage
stability
data
for
livestock
commodities
are
required
to
support
the
storage
intervals
used
in
the
livestock
feeding
studies.
Label
Language:
Mitigating
circumstances
for
exposure
to
fenarimol
residues
may
include
watering
in
after
application
to
turf.
This
instruction,
however,
does
not
prevent
contact
with
treated
turf
prior
to
watering
in.
The
current
granular
label
(
EPA
Reg.
No.
228
298)
recommends,
but
does
not
require
watering
in.
The
soluble
concentrate
label
(
EPA
Reg.
No.
62719
142)
does
not
mention
watering
in.
Therefore,
label
language
should
be
strengthened
to
ensure
that
watering
in
occurs
immediately
after
application.
When
fenarimol
is
applied
to
stadium
or
professional
athletic
fields,
applicators
should
water
in
product
immediately
after
application,
or
do
not
enter
or
allow
others
to
enter
treated
area
for
24
hours
after
application.
If
product
is
watered
in
after
treatment,
do
not
enter
or
allow
other
persons
to
enter
until
area
has
dried.
| epa | 2024-06-07T20:31:43.738410 | regulations | {
"license": "Public Domain",
"url": "https://downloads.regulations.gov/EPA-HQ-OPP-2002-0250-0005/content.txt"
} |
EPA-HQ-OPP-2002-0250-0006 | Supporting & Related Material | "2002-09-24T04:00:00" | null | UNITED
STATES
ENVIRONMENTAL
PROTECTION
AGENCY
WASHINGTON,
D.
C.
20460
PC
Code:
206600
DP
Barcode
D282389,
D284487
DATE:
July
31,
2002
MEMORANDUM
SUBJECT:
Updated
Drinking
Water
Assessment
to
Support
TRED
for
Fenarimol
FROM:
Norman
Birchfield,
Ph.
D.
Biologist
Environmental
Risk
Branch
IV
Environmental
Fate
and
Effects
Division
(
7507C)
THROUGH:
Elizabeth
Behl,
Chief
Environmental
Risk
Branch
IV,
Environmental
Fate
and
Effects
Division
(
7507C)
TO:
Barry
O'Keefe,
Risk
Assessor
(
7508C)
Health
Effects
Division
Tom
Myers,
Product
Manager
Special
Review
and
Reregistration
Division
(
7508C)
This
memo
presents
revised
Tier
I
surface
water
and
groundwater
Estimated
Environmental
Concentrations
(
EECs)
for
fenarimol
and
its
aquatic
photodegradates.
This
assessment
updates
the
August
6,
2000
Drinking
Water
Assessment
from
E.
Laurence
Libelo
(
D276622).
Submissions
from
the
registrant
(
MRID
45716301,
45716302,
45716303,
45716304)
were
considered
in
this
revision.
The
surface
water
values
presented
here
were
calculated
using
FIRST
(
surface
water)
modeling
of
applications
to
turf.
The
FIRST
inputs
in
this
assessment
are
identical
to
the
previous
assessment,
except
aquatic
concentrations
were
estimated
assuming
no
aqueous
photolysis,
which
appears
to
be
fenarimol's
most
significant
route
of
dissipation,
and
minor
corrections
were
made
to
the
application
rate
and
interval.
The
result
is
intended
to
provide
a
screening
level
estimate
of
combined
concentrations
of
fenarimol
and
its
aquatic
degradates.
Although
the
combined
exposure
estimates
presented
for
parent
and
degradates
are
expected
to
be
conservative,
there
is
substantial
uncertainty
as
to
the
identity,
fate,
and
behavior
of
photolysis
degradates
due
to
shortcomings
in
the
environmental
fate
studies.
Page
2
of
7
The
surface
water
acute
EEC
for
fenarimol
and
degradates
is
261
ppb.
The
surface
water
chronic
EEC
for
fenarimol
and
degradates
is
84
ppb.
These
values
represent
the
1
in
10
year
peak
surface
water
concentration
and
1
in
10
year
mean
yearly
concentration.
Fenarimol
is
generally
stable
(
except
in
water
exposed
to
sunlight)
and
moderately
mobile
in
the
environment.
Based
on
its
chemical
properties
it
is
likely
that
fenarimol
will
accumulate
in
the
environment.
The
fate,
persistence,
and
identity
of
fenarimol's
degradates
are
largely
unknown.
The
groundwater
values
presented
were
calculated
using
the
SCIGROW
model
and
the
application
rate
to
turf.
The
SCIGROW
inputs
are
identical
to
the
previous
assessment
except
the
application
rate
was
increased
slightly
to
be
consistent
with
labeled
rates.
The
concentration
estimates
for
groundwater
are
for
parent
fenarimol
only.
The
aqueous
photoproducts
which
may
occur
in
surface
water
are
unlikely
to
be
present
in
groundwater
at
a
significant
level.
The
groundwater
acute
and
chronic
estimated
concentration
for
fenarimol
is
16
ppb.
As
stated
in
the
previous
assessment,
these
concentration
estimates
are
based
on
environmental
fate
studies
conducted
in
the
1970s
and
early
1980s.
The
quality
of
the
data
provided
by
these
studies
is
significantly
lower
then
currently
required.
By
current
standards
most
of
these
studies
would
not
be
considered
acceptable
and
the
results
would
not
be
considered
of
sufficient
quality
to
allow
an
acceptable
assessment
of
the
environmental
fate
of
this
compound.
Therefore
the
EECs
presented
here
are
somewhat
uncertain,
and
may
change
if
additional
data
become
available.
Based
on
usage
information
from
USGS
(
see
Figure
1)
and
provided
by
the
registrant,
annual
fenarimol
usage
for
turf
and
agriculture
is
well
under
100,000
pounds
per
year
distributed
across
several
states.
Figure
1.
Agricultural
fenarimol
usage
estimates
from
the
USGS.
These
estimates
do
not
include
turf
usage.
(
http://
ca.
water.
usgs.
gov/
pnsp/
use92/
fenarml.
html)
Page
3
of
7
EFED
surface
water
modeling
for
drinking
water
uses
a
percent
cropped
area
factor
(
PCA).
The
PCA
represents
the
fraction
of
a
watershed
that
is
cropped
and
treated
with
the
pesticide
being
modeled.
In
the
absence
of
having
a
PCA
factor
for
a
particular
crop
a
default
PCA
of
0.87
is
used.
The
0.87
factor
represents
the
maximum
fraction
of
a
watershed
in
the
US
that
is
agriculturally
cropped.
This
default
was
used
for
fenarimol
modeling
on
turf.
EFED
is
currently
attempting
better
define
PCA
factors
for
turf
scenarios
but
recognizes
that
it
is
unlikely
that
87%
of
a
watershed
used
for
drinking
water
would
be
treated
with
fenarimol
at
the
maximum
rate
allowed
only
for
turf
applications.
The
percent
cropped
area
factor
used
in
fenarimol
modeling
is
most
likely
overestimated
and
adds
to
the
conservatism
of
the
surface
water
assessment.
The
model
estimates
for
fenarimol
drinking
water
exposure
assume
that
87%
of
a
watershed
are
treated
at
the
maximum
application
rate
for
turf
(
the
highest
rate
allowed
on
the
RubiganTM
AS
product
label).
Given
the
relatively
low
usage
of
fenarimol
across
the
country
it
is
highly
unlikely
that
the
amount
applied
to
the
watershed
in
the
model
will
be
concentrated
in
any
real
watershed
used
to
derive
drinking
water.
The
groundwater
concentration
estimates
are
not
expected
to
be
as
conservative
as
the
surface
water
estimate.
Groundwater
used
for
drinking
water
is
more
likely
to
be
affected
by
fenarimol
use
in
the
immediate
area.
Therefore,
the
relatively
low
usage
of
fenarimol
across
the
US
would
1
From
RubiganTM
AS
label
dated
03/
31/
2000.
Page
4
of
7
be
expected
to
reduce
the
number
of
people
exposed
but
not
the
magnitude
of
exposure.
Fenarimol's
chemical
properties
(
long
persistence,
moderate
mobility)
suggest
that
groundwater
contamination
is
likely
to
occur
as
a
result
of
use
of
this
chemical.
The
magnitude
of
groundwater
contamination
would
be
expected
depend
on
the
application
rate,
the
number
of
applications,
the
soil
type,
and
the
amount
of
rainfall
and
irrigation
at
the
site.
In
summary,
the
surface
water
EECs
are
not
likely
to
underestimate
exposure
to
fenarimol
and
its
degradates
based
on
the
conservative
inputs
to
the
model
(
i.
e.,
default
PCA,
no
decay
via
the
major
degradation
pathway,
and
the
concentrated
application
scenario
modeled
is
unlikely
to
occur
in
a
real
watershed
where
drinking
water
is
derived).
The
uncertainties
related
to
the
aqueous
photoproducts
would
likely
be
addressed
through
completion
of
a
satisfactory
guideline
aqueous
photolysis
study
(
161
2,
835.2240).
Other
uncertainties
would
likely
be
addressed
through
the
completion
of
satisfactory
guideline
studies
shown
in
Table
3.
If
modeled
groundwater
concentrations
exceed
levels
of
concern
a
prospective
groundwater
monitoring
study
should
be
conducted.
Table
1.
Model
Input
Parameters
for
Fenarimol
Water
Solubility
(
25
C)
14
mg/
L
Hydrolysis
Half
Life
(
pH7)
stable
Aerobic
Soil
Metabolism
Half
Life
1515
days
Aerobic
Aquatic
Metabolism
Stable
Photolysis
Half
Life
Stable
(
in
the
previous
assessment
for
fenarimol
alone
the
input
was
3
days)
Adsorption
Coefficient
Kd
(
Koc)
Kd
=
6.35
(
Koc
=
400)
Application
Method
low
pressure
ground
spray
Wetted
in
Yes
Application
Rate
2.73
lbs.
a.
i./
acre1
(
2.53
lbs.
a.
i./
acre
in
previous
assessment)
Application
Frequency
2
apps
30
days
apart1
(
2
apps
7
days
apart
in
previous
assessment)
2
No
MRID
is
listed
for
this
submission:
"
Photodegradation
Study
of
C14
Fenarimol
on
Soil
Surface"
Kent
Kabler
and
Mark
Carpenter.
September
30,
1988.
ABC
amended
final
report
#
36924.
Soil
photodegradate
concentrations
continued
to
increase
through
the
30
day
duration
of
the
study.
An
unknown
photodegradate
was
present
at
5.9%
at
study
termination.
Page
5
of
7
Table
2.
Modeling
Results
for
Application
of
Fenarimol
to
Turf
Model
Concentration
(
ppb)
current
assessment
previous
assessment
FIRST
Peak
Day
(
Acute)
261
242
FIRST
Annual
Average
(
Chronic)
84
59
SCIGROW
Ground
Water
Value
16
14
Table
3.
Status
of
Environmental
Fate
Data
Requirements
Guideline
#
Data
Requirement
MRID
/
ACC.#
Status
161
1
Hydrolysis
84916
Fulfilled
161
2
Photodegradation
water
129103
Unfulfilled
161
3
Photodegradation
soil
00129102
00084918
Kabler
and
Carpenter
19882
Unfulfilled
162
1
Aerobic
soil
metabolism
248702
Fulfilled
162
3
Anaerobic
aquatic
metabolism
248702
Unfulfilled
162
4
Aerobic
aquatic
metabolism
Not
available
Unfulfilled
163
1
Aged
leaching
Adsorption/
desorption
133472
142483
Unfulfilled
Unfulfilled
163
2
Volatility
lab
149384
Fulfilled
164
1
Terrestrial
field
dissipation
117511
Unfulfilled
165
4
Fish
Bio
Acc.
Not
available
Unfulfilled
Page
6
of
7
FIRST
MODEL
RUN
Previous
assessment:
RUN
No.
1
FOR
fenarimol
ON
turf
*
INPUT
VALUES
*
RATE
(#/
AC)
No.
APPS
&
SOIL
SOLUBIL
APPL
TYPE
%
CROPPED
INCORP
ONE(
MULT)
INTERVAL
Kd
(
PPM
)
(%
DRIFT)
AREA
(
IN)
2.530(
5.052)
2
7
6.3
14.0
GROUND(
6.4)
87.0
.0
FIELD
AND
RESERVOIR
HALFLIFE
VALUES
(
DAYS)
METABOLIC
DAYS
UNTIL
HYDROLYSIS
PHOTOLYSIS
METABOLIC
COMBINED
(
FIELD)
RAIN/
RUNOFF
(
RESERVOIR)
(
RES.
EFF)
(
RESER.)
(
RESER.)
1515.00
2
N/
A
3.00
372.00
.00
372.00
UNTREATED
WATER
CONC
(
MICROGRAMS/
LITER
(
PPB))
Ver
1.0
MAY
16,
2001
PEAK
DAY
(
ACUTE)
ANNUAL
AVERAGE
(
CHRONIC)
CONCENTRATION
CONCENTRATION
242.271
58.904
Current
assessment:
RUN
No.
1
FOR
fenarimol
ON
turf
*
INPUT
VALUES
*
RATE
(#/
AC)
No.
APPS
&
SOIL
SOLUBIL
APPL
TYPE
%
CROPPED
INCORP
ONE(
MULT)
INTERVAL
Kd
(
PPM
)
(%
DRIFT)
AREA
(
IN)
2.730(
5.423)
2
30
6.3
14.0
GROUND(
6.4)
87.0
.0
FIELD
AND
RESERVOIR
HALFLIFE
VALUES
(
DAYS)
METABOLIC
DAYS
UNTIL
HYDROLYSIS
PHOTOLYSIS
METABOLIC
COMBINED
(
FIELD)
RAIN/
RUNOFF
(
RESERVOIR)
(
RES.
EFF)
(
RESER.)
(
RESER.)
1515.00
0
N/
A
.00
.00
.00
.00
UNTREATED
WATER
CONC
(
MICROGRAMS/
LITER
(
PPB))
Ver
1.0
MAY
16,
2001
PEAK
DAY
(
ACUTE)
ANNUAL
AVERAGE
(
CHRONIC)
CONCENTRATION
CONCENTRATION
260.719
83.523
Page
7
of
7
SCIGROW
MODEL
RUNS
Previous
assessment:
RUN
No.
1
FOR
fenarimol
INPUT
VALUES
APPL
(#/
AC)
APPL.
URATE
SOIL
SOIL
AEROBIC
RATE
NO.
(#/
AC/
YR)
KOC
METABOLISM
(
DAYS)
2.530
2
5.060
400.0
1515.0
GROUND
WATER
SCREENING
CONCENTRATIONS
IN
PPB
14.490690
A=
1500.000
B=
405.000
C=
3.176
D=
2.607
RILP=
4.423
F=
.457
G=
2.864
URATE=
5.060
GWSC=
14.490690
Current
assessment:
SCIGROW
VERSION
2.1
MAY
1,
2001
RUN
No.
1
FOR
fenarimol
**
INPUT
VALUES
**
APP
RATE
APPS/
TOTAL/
SOIL
AEROBIC
SOIL
METAB
(
LBS/
AC)
YEAR
SEASON
KOC
HALFLIFE
(
DAYS)
2.730
2
5.460
400.0
1515.00
GROUND
WATER
SCREENING
CONCENTRATION
(
IN
PPB)
15.5444
| epa | 2024-06-07T20:31:43.755189 | regulations | {
"license": "Public Domain",
"url": "https://downloads.regulations.gov/EPA-HQ-OPP-2002-0250-0006/content.txt"
} |
EPA-HQ-OPP-2002-0250-0007 | Supporting & Related Material | "2002-09-24T04:00:00" | null | TXR
NO.
0051051
August
13,
2002
MEMORANDUM
SUBJECT:
FENARIMOL
2nd
Report
of
the
FQPA
Safety
Factor
Committee.
NOTE:
THIS
REPORT
REPLACES
THE
PREVIOUS
REPORT
OF
THE
FQPA
SAFETY
FACTOR
COMMITTEE
DATED
SEPT.
28,
2001
(
HED
DOC.
NO.
014688).
FROM:
Brenda
Tarplee,
Executive
Secretary
FQPA
Safety
Factor
Committee
Health
Effects
Division
(
7509C)
THROUGH:
Ed
Zager,
Chairman
FQPA
Safety
Factor
Committee
Health
Effects
Division
(
7509C)
TO:
Barry
O'Keefe,
Risk
Assessor
Reregistration
Branch
3
Health
Effects
Division
(
7509C)
PC
Code:
206600
The
Health
Effects
Division
(
HED)
FQPA
Safety
Factor
Committee
(
SFC)
met
on
July
29,
2002
to
evaluate
the
hazard
and
exposure
data
for
Fenarimol
with
regard
to
making
a
decision
on
the
additional
safety
factor
for
the
protection
of
infants
and
children.
The
SFC
concluded
that,
based
on
reliable
data,
an
additional
safety
factor
of
3X
is
necessary
to
protect
the
safety
of
infants
and
children
in
assessing
Fenarimol
exposures
and
risks.
This
report
replaces
the
previous
report
of
the
FQPA
Safety
Factor
Committee
dated
Sept.
28,
2001
(
HED
Doc.
No.
014688
).
2
I.
HAZARD
ASSESSMENT
(
Extracted
from
the
THIRD
Report
of
the
Hazard
Identification
Assessment
Review
Committee
for
Fenarimol
dated
July
29,
2002;
HED
DOC
No.
0050977
)
1.
Adequacy
of
the
Toxicology
Database
The
HED
Hazard
Identification
Assessment
Review
Committee
(
HIARC)
concluded
that
the
Fenarimol
toxicology
database
is
complete
with
respect
to
FQPA
with
the
exception
of
a
special
developmental
toxicity
study
to
assess
for
potential
hormonal
effects.
At
the
July
10,
2001
HIARC
meeting,
it
was
determined
that
a
developmental
neurotoxicity
(
DNT)
study
in
rat
that
incorporated
a
special
provision
to
assess
for
hormonal
effects
is
required
(
TXR.
No.
014662).
The
Registrant
responded
with
a
request
"
that
the
Agency
rescind
the
requirement
for
a
developmental
neurotoxicity
study
of
unproven
design"
since
the
DNT
is
not
designed
to
investigate
the
endpoints
mentioned
(
mating
behavior
in
male
and
difficult
labor
in
females)
(
Letter
from
Gowan,
dated
April
10,
2002).
On
May
23,
2002,
the
HIARC
concurred
with
the
Registrant's
rationale
and
rescinded
their
previous
request
for
the
DNT.
The
HIARC,
instead
is
requesting
a
special
developmental
toxicity
study
that
assesses
the
hormonal
effects
in
rats
especially
related
to
inhibition
of
aromatase.
The
protocol
for
this
study
should
be
submitted
to
HED
for
review
prior
to
initiating
the
study.
The
HIARC
concluded
that
a
3X
database
uncertainty
factor
(
UF
DB)
is
needed
in
the
absence
of
this
study.
The
committee
considered
3X
(
as
opposed
to10X)
to
be
adequate
since
there
is
a
2
fold
difference
between
the
NOAEL/
LOAEL
for
the
most
sensitive
indicator
and
it
is
considered
unlikely
that
the
results
of
the
special
developmental
toxicity
study
(
tested
at
comparable
doses
of
the
twogeneration
reproduction
study)
will
demonstrate
a
NOAEL
three
times
lower
than
the
current
NOAEL
of
0.6
mg/
kg/
day
from
the
two
generation
reproduction
study
used
for
establishing
the
chronic
RfD
(
HED
DOC
No.
0050977).
2.
Determination
of
Susceptibility
The
data
provided
no
indication
of
increased
susceptibility
of
rats
or
rabbits
to
in
utero
and/
or
postnatal
exposure
to
Fenarimol.
3.
Degree
of
Concern
and
Residual
Uncertainties
The
HIARC
concluded
that
there
are
no
residual
uncertainties
for
pre
and/
or
post
natal
toxicity
in
any
of
the
available
studies
with
Fenarimol.
4.
Other
Studies
There
are
several
studies
conducted
as
both
non
guideline
studies
by
the
registrant
as
well
as
reports
in
the
published
literature
that
investigate
the
mechanism
of
the
reduced
fertility
3
in
males
and
dystocia
in
females
caused
by
Fenarimol.
These
studies
indicate
that
Fenarimol
inhibits
aromatase
the
enzyme
that
converts
androgens
to
estrogens.
Thus,
Fenarimol
is
regarded
as
affecting
hormonal
balance
in
mammals.
Fenarimol
also
acts
as
a
fungicide
by
adversely
affecting
the
formation
of
the
fungal
sterol,
ergosterol.
The
HED
Mechanism
of
Toxicity
Assessment
Review
Committee
concluded
that
inhibition
of
aromatase
activity
and
its
expression
(
i.
e.
reduced
fertility
and
dystocia
in
rats)
should
be
regarded
as
endpoints
for
human
risk
assessment
(
June
21,
2001).
II.
EXPOSURE
ASSESSMENT
1.
Dietary
(
Food)
Exposure
Considerations
(
Correspondence:
S.
Knizner
to
B.
Tarplee
dated
08/
13/
01)
No
changes
since
the
last
review
per
Fenarimol
Team.
Fenarimol
is
a
fungicide
registered
for
use
on
many
foods
considered
to
be
highly
consumed
by
infants
and
children
including
apples,
bananas,
and
pears.
The
HED
Metabolism
Assessment
Review
Committee
(
MARC)
concluded
that
the
tolerance
expression
for
Fenarimol
should
be
expressed
as
Fenarimol
per
se.
For
risk
assessment
purposes,
residues
of
parent
and
two
metabolites
[
alpha(
2
chlorophenyl)
alpha(
4
chlorophenyl
1,4
dihydro
5
pyrimidinemethanol
and
5[(
2
chlorophenyl(
4
chlorophenyl)
methyl
3,4
dihydro
4
pyrimidinol
measured
as
the
total
of
5[(
2
chlorophenyl)(
4
chlorophenyl
methyl]
pyrimidine]
should
be
included
for
bananas
and
grapes.
Current
tolerances
are
established
at
levels
ranging
from
0.01
ppm
to
3.0
ppm
(
40CFR
§
180.421).
There
are
established
Codex
MRLs
for
Fenarimol
per
se.
The
available
data
bases
for
Fenarimol
consist
of
crop
field
trial
data,
FDA
monitoring
data,
and
Total
Diet
Survey
data.
FDA
monitoring
data
(
1997
through
1999;
LOD
=
0.003
ppm,
parent
only)
include:
more
than
300
apple
samples
with
no
detects;
more
than
500
grape
samples
with
no
detects;
more
than
300
pear
samples
with
no
detects;
more
than
600
banana
samples
with
no
detects;
and
more
than
100
cherry
samples
with
6
detects
and
a
maximum
detection
of
0.214
ppm.
A
Quantitative
Usage
Analysis
for
Fenarimol
was
prepared
by
BEAD
(
J.
Alsadek;
dated
05/
01/
01).
The
sources
cited
in
this
analysis
include
EPA
data
(
90
99),
USDA/
NASS
(
90
99),
Cal
DPR
(
93
95)
and
National
Center
for
Food
and
Agricultural
Policy
(
c.
92).
The
HED
Dietary
Exposure
Evaluation
Model
(
DEEM)
is
used
to
assess
the
risk
from
dietary
exposure
to
Fenarimol
residues
in
food
(
no
acute
RfD
is
established).
The
chronic
DEEM
analysis
will
be
refined
using
FDA
data
and
anticipated
residues
from
field
trial
data
with
the
available
percent
of
crop
treated
estimates
and
processing
data.
The
Committee
recognizes
that
further
refinement
to
the
dietary
food
exposure
analyses
may
be
required
as
the
risk
assessment
is
developed.
Therefore,
provided
the
final
dietary
food
exposure
assessment
includes
all
metabolic
residues
of
concern
and
does
not
4
underestimate
the
potential
risk
for
infants
and
children,
the
safety
factor
recommendations
of
this
Committee
stand.
2.
Dietary
(
Drinking
Water)
Exposure
Considerations
(
Correspondence:
N.
Birchfield
to
B.
Tarplee
dated
July
24,
2002)
The
environmental
fate
database
is
complete
enough
to
provide
a
Tier
1
assessment
of
drinking
water
exposure.
The
data
are
based
on
studies
done
in
the
late
1970s
and
early
1980s
so
are
somewhat
uncertain.
Based
on
current
standards
most
of
the
studies
would
be
judged
to
be
unacceptable
but
they
appear
to
provide
useable
information.
If
a
higher
tier
assessment
is
required
new
studies
must
be
done.
The
data
indicate
that
parent
Fenarimol
is
stable
and
moderately
mobile
in
the
environment.
It
has
been
shown
to
persist
in
treated
field
for
several
years,
and
accumulation
in
soil
and
groundwater
over
time
is
possible.
EFED
concluded
that
the
only
significant
degradation
pathway
appears
to
be
aqueous
photolysis
and
one
significant
degradate
has
been
identified,
4
chloro
2(
5
pyrimidyl)
2'
clorobenzophenone.
Because
of
limitations
in
analytical
methodology
in
the
1970s
and
early
1980s
when
the
fate
studies
were
conducted,
the
identification
and
quantification
of
degradation
products
is
limited.
No
information
is
available
on
the
fate
and
transport
properties
of
this
or
other
possible
degradates.
The
HED
MARC
concluded
that
the
aqueous
photolysis
degradate
of
Fenarimol
[
4
chloro
2(
5
pyrimidyl)
2'
chlorobenzophenone]
should
be
included
in
the
drinking
water
risk
assessment.
Only
very
limited
monitoring
data
are
available
and
the
studies
have
not
been
reviewed.
Therefore,
Tier
1
screening
models
were
used
to
determine
estimated
environmental
concentrations
(
EECs)
for
use
in
drinking
water
risk
assessment:
FIRST
for
surface
water
and
SCIGROW
for
groundwater.
For
surface
water,
combined
EECs
for
Fenarimol
and
all
aqueous
photolysis
degradates
(
major
and
minor)
were
included
in
the
most
recent
drinking
water
assessment
by
modeling
Fenarimol
as
being
stable
in
surface
water.
The
SCIGROW
modeling
did
not
include
degradates
but
the
aqueous
photoproduct
is
expected
to
occur
predominately
in
surface
water.
3.
Residential
Exposure
Considerations
(
Correspondence:
B.
O'Keefe
to
B.
Tarplee
dated
July
25,
2002)
Fenarimol
is
currently
registered
for
use
on
ornamental
trees,
shrubs,
lawns,
and
turf
including
golf
courses.
Postapplication
dermal
and
incidential
oral
exposures
to
children
and
infants
are
possible;
mainly
from
exposure
to
treated
turf.
It
is
possible
that
Fenarimol
could
be
applied
twice
in
a
season
to
residential
turf
by
resident
or
professional
applicators;
i.
e.
once
or
twice
at
the
maximum
application
rate
(
2.73
lb
ai/
acre)
or
twice
as
a
split
application
(
half
max.
rate).
Additionally,
Fenarimol
could
be
applied
to
residential
turf
as
many
as
12
times
per
season
at
significantly
lower
rates;
i.
e.
0.51
lb
ai/
acre.
However,
based
upon
conversations
with
the
registrants,
only
one
to
two
applications
per
season
are
anticipated
to
turf,
since
users
rotate
and
switch
between
different
systemic
and
5
contact
fungicides,
and
applications
are
only
anticipated
when
conditions
are
suitable
for
fungal
growth.
It
is
also
possible
that
Fenarimol
could
be
applied
up
to
seven
times
per
season
to
residential
ornamentals
(
0.04875
lb
ai/
acre)
and
backyard
orchards
(
0.09375
lb
ai/
acre);
although
these
scenarios
are
considered
unlikely
based
upon
label
language.
Only
short
term
non
cancer
risks
to
residential
handlers
were
anticipated.
The
assessment
uses
the
revised
draft
Standard
Operating
Procedures
(
SOPs)
for
Residential
Exposure
Assessment,
and
includes
surrogate
data
from
the
Pesticide
Handlers
Exposure
Database
(
PHED)
for
loading/
applying
with
a
belly
grinder
type
granular
spreader
and
applying
by
hand,
and
the
Outdoor
Residential
Exposure
Task
Force
(
ORETF)
for
loading/
applying
with
a
push
type
granular
spreader.
Short
term
non
cancer
risks
from
residential
postapplication
exposures
were
estimated
for
Fenarimol.
The
scenarios
assessed
for
the
purpose
of
screening
level
risk
estimates
included
adults
and
children
performing
high
contact
play
or
work
activities
on
treated
lawns,
and
adults
mowing
lawns
or
golfing.
Small
children
were
also
assessed
for
incidental
oral
exposure
from
hand
to
mouth
activities
while
playing
on
a
treated
lawn.
Some
of
these
exposures
were
combined,
where
it
was
deemed
reasonably
likely
activities
would
co
occur.
Residential
risk
estimates
utilized
dissipation
rate
data
from
a
turf
transferable
residue
(
TTR)
study,
as
well
as
the
EPA's
original
and
revised
Draft
SOPs
for
Residential
Exposure
Assessment.
The
TTR
data
from
the
submitted
turf
study
had
several
limitations
and
were
considered
unacceptable.
However,
a
dissipation
rate
(
8%
daily)
derived
from
these
data
was
used
to
calculate
exposure
after
day
zero.
This
is
a
slower
dissipation
rate
than
the
10%
rate
listed
in
HED's
SOP.
Also,
the
data
showed
that
6.1%,
0.85%,
and
0.59%
(
for
CA,
IN
&
MS,
respectively)
of
the
applied
Fenarimol
was
detected
on
DAT
0.
By
comparison,
the
Agency's
SOP
uses
a
transfer
efficiency
(
percent
of
application
rate)
of
5%.
The
more
conservative
data
will
be
used
in
the
assessment.
NOTE:
Since
the
time
of
this
meeting,
the
FQPA
SFC
has
been
informed
that
the
registrant
has
agreed
to
drop
all
residential
uses
from
the
label.
III.
SAFETY
FACTOR
RECOMMENDATION
AND
RATIONALE
1.
FQPA
Safety
Factor
Recommendations
The
FQPA
SFC
recommends
that
OPP
depart
from
the
default
10X
additional
safety
factor
and
instead
use
a
different
additional
safety
factor
of
3X.
This
recommendation
is
based
on
reliable
data
supporting
the
findings
set
forth
below.
A.
Traditional
Additional
Safety
Factor
(
Addressing
Data
Deficiencies)
The
HIARC
concluded,
and
the
FQPA
SFC
concurred,
that
a
3X
additional
traditional
database
uncertainty
factor
to
address
the
data
deficiency
for
the
developmental
6
neurotoxicity
study.
The
rationale
for
why
reliable
data
support
the
safety
of
using
a
3X
to
address
this
data
deficiency
is
discussed
above
in
§
I.
1.
B.
Special
FQPA
Safety
Factors
Taking
into
account
the
recommendation
regarding
the
data
deficiency,
the
FQPA
SFC
recommends
that
no
Special
FQPA
Safety
Factor
is
necessary
to
protect
the
safety
of
infants
and
children
in
assessing
Fenarimol
exposure
and
risks.
2.
Rationale
and
Findings
Regarding
Recommendation
on
Special
FQPA
Safety
Factor
No
special
FQPA
safety
factor
was
needed
because:
There
is
no
evidence
of
increased
susceptibility
of
rat
or
rabbit
fetuses
following
in
utero
exposure
in
the
developmental
studies
with
Fenarimol.
There
is
no
evidence
of
increased
susceptibility
of
young
rats
in
the
reproduction
study
with
Fenarimol.
HIARC
concluded
there
are
no
residual
uncertainties
for
pre
and/
or
postnatal
exposure.
There
are
no
residual
uncertainties
identified
in
the
exposure
databases.
The
dietary
food
exposure
assessment
(
chronic
only;
no
acute
endpoint
was
identified)
is
refined
using
FDA
data
and
anticipated
residues
from
field
trial
data
with
the
available
percent
of
crop
treated
estimates
and
processing
data.
EFED
has
provided
conservative
surface
water
modeling
estimates
which
include
Fenarimol
and
all
aqueous
photolysis
degradates
(
which
are
expected
to
occur
predominately
in
surface
water).
The
HED
Residential
SOPs
and
dissipation
rate
data
from
a
TTR
study
will
be
used
to
assess
post
application
exposure
to
children
as
well
as
incidental
oral
exposure
of
toddlers.
These
assessments
will
not
underestimate
the
exposure
and
risks
posed
by
Fenarimol.
NOTE:
Since
the
time
of
this
meeting,
the
FQPA
SFC
has
been
informed
that
the
registrant
has
agreed
to
drop
all
residential
uses
from
the
label.
3.
Application
of
the
FQPA
Safety
Factors
(
Population
Subgroups
/
Risk
Assessment
Scenarios)
The
FQPA
safety
factor
recommendation
is
for
a
3X
traditional
database
uncertainty
factor
to
address
data
deficiencies
and
no
additional
Special
FQPA
safety
factor.
The
3X
safety
factor
should
be
applied
to
all
dietary
and
residential
non
dietary
exposure
scenarios.
No
other
FQPA
safety
factor
would
be
appropriate
for
Fenarimol.
4.
Summary
of
FQPA
Safety
Factors
Summary
of
FQPA
Safety
Factors
for
Fenarimol
7
LOAEL
to
NOAEL
(
UF
L)
Subchronic
to
Chronic
(
UFS)
Incomplete
Database
(
UFDB)
Special
FQPA
Safety
Factor
(
Hazard
and
Exposure)
Magnitude
of
Factor
1X
1X
3X
1X
Rationale
for
the
Factor
No
LOAEL
to
NOAEL
extrapolations
performed
No
subchronic
to
Chronic
extrapolations
performed
For
the
lack
of
a
special
developmental
toxicity
study
to
assess
for
potential
hormonal
effects
No
residual
concerns
regarding
preor
post
natal
toxicity
or
completeness
of
the
toxicity
or
exposure
databases
Endpoints
to
which
the
Factor
is
Applied
Not
Applicable
Not
Applicable
All
Dietary
and
Residential
Non
Dietary
exposure
assessments.
Not
Applicable
| epa | 2024-06-07T20:31:43.761089 | regulations | {
"license": "Public Domain",
"url": "https://downloads.regulations.gov/EPA-HQ-OPP-2002-0250-0007/content.txt"
} |
EPA-HQ-OPP-2002-0250-0008 | Supporting & Related Material | "2002-09-24T04:00:00" | null | UNITED
STATES
ENVIRONMENTAL
PROTECTION
AGENCY
WASHINGTON,
D.
C.
20460
OFFICE
OF
PREVENTION,
PESTICIDES
AND
TOXIC
SUBSTANCES
August
1,
2002
MEMORANDUM
SUBJECT:
Fenarimol.
Amendment
to
Revised
HED
Human
Health
Assessment
for
the
Tolerance
Reassessment
Eligibility
Decision
(
TRED)
Document.
Chemical
No.
206600.
DP
Barcode
No.
D284644.
FROM:
Barry
O'Keefe,
Risk
Assessor
Reregistration
Branch
3
Health
Effects
Division
(
7509C)
THRU:
Catherine
Eiden,
Branch
Senior
Scientist
Reregistration
Branch
3
Health
Effects
Division
(
7509C)
TO:
Tom
Myers,
Chemical
Review
Manager
Special
Review
and
Reregistration
Division
(
7508C)
This
memorandum
describes
amendments
to
the
Revised
Health
Effects
Division's
(
HED's)
Tolerance
Reassessment
Eligibility
Decision
(
TRED)
Document
for
fenarimol
(
June
7,
2002;
D283429)
taking
into
consideration
recent
decisions
from
the
HED's
Food
Quality
Protection
Act
(
FQPA)
Safety
Factor
Committee
(
SFC).
Previously,
the
FQPA
SFC
recommended
that
the
FQPA
safety
factor
for
protection
of
infants
and
children
should
be
retained
at
10x
for
fenarimol
based
on
the
following:
1)
a
developmental
neurotoxicity
study
with
fenarimol
is
required
to
determine
if
the
potential
effects
elicited
by
inhibition
of
aromatase
will
result
in
effects
in
the
offspring;
and
2)
the
drinking
water
assessment
did
not
include
the
water
degradate
of
concern,
because
the
environmental
fate
database
is
incomplete
for
the
aquatic
photo
degradate
of
fenarimol,
4
chloro
2(
5
pyrimidyl)
2'
chlorobenzophenone.
Consequently,
the
drinking
water
assessment
may
underestimate
exposure.
The
FQPA
SFC
reevaluated
fenarimol
because
the
Environmental
Fate
and
Effects
Division
(
EFED)
received
additional
information
on
the
aquatic
photo
degradate
and
revised
the
drinking
water
assessment.
The
updated
drinking
water
assessment
(
July
31,
2002;
D284487)
was
revised
to
include
fenarimol
and
its
aquatic
photodegradates.
The
model
inputs
were
adjusted
so
that
aquatic
concentrations
were
estimated
assuming
no
aqueous
photolysis,
which
appears
to
be
fenarimol's
most
significant
route
of
dissipation
in
the
environment.
Minor
model
input
corrections
were
also
made
to
2
the
application
rate
and
interval.
The
result
provides
a
screening
level
estimate
of
combined
concentrations
of
fenarimol
and
its
aquatic
degradates
that
is
conservative
and
that
does
not
underestimate
exposure.
As
a
result
of
this
reassessment
the
chronic
EECs
increased
from
59
to
84
g/
L
for
surface
water,
and
from
14
to
16
g/
L
for
ground
water.
Although,
there
is
still
some
uncertainty
as
to
the
identity,
fate,
and
behavior
of
the
photolysis
degradates
of
fenarimol,
data
will
be
required
to
address
this
uncertainty.
The
FQPA
SFC
also
reassessed
the
uncertainty
surrounding
the
potential
effects
elicited
by
inhibition
of
aromatase
by
fenarimol.
On
May
23,
2002,
the
HED
Hazard
Identification
Assessment
Review
Committee
(
HIARC)
met
and
reassessed
the
need
for
a
developmental
neurotoxicity
study
with
fenarimol.
The
HIARC
concluded
(
July
29,
2002;
TXR
No.
0050977)
that
a
special
developmental
toxicity
study
to
assess
for
hormonal
effects
is
required
for
fenarimol,
and
a
database
uncertainty
factor
of
3x
is
required
until
the
data
are
received
and
reviewed.
Based
on
the
updated
drinking
water
assessment
and
the
recent
HIARC
conclusions
regarding
aromatase,
the
FQPA
SFC
recommended
that
the
FQPA
safety
factor
for
fenarimol
be
reduced
from
10x
to
3x.
Given
this
reduction
in
the
FQPA
safety
factor,
the
target
margins
of
exposure
(
MOEs)
for
fenarimol
are
therefore
reduced;
i.
e.
for
residential
short
term
handler
and
postapplication
exposures
the
target
MOE
is
reduced
from
3000
to
900,
and
for
residential
intermediate
term
handler
and
postapplication
exposures
the
target
MOE
is
reduced
from
1000
to
300.
The
MOEs
(
i.
e.
risk
estimates)
for
each
exposure
scenario
remain
unchanged.
Based
on
these
reductions
in
target
MOEs,
risk
estimates
for
several
short
and
intermediate
term
handler
and
postapplication
exposure
scenarios
still
exceed
the
Agency's
level
of
concern.
However,
HED
has
been
informed
by
SRRD
that
the
registrant
has
agreed
to
amend
their
product
labels
to
prohibit
handling
(
i.
e.
mixing,
loading
or
applying)
of
fenarimol
by
residents.
Therefore,
residential
handler
exposure
scenarios
should
no
longer
exist.
Additionally,
the
registrants
have
agreed
to
extend
the
re
application
interval
to
turf
to
30
days;
thereby
eliminating
any
residential
intermediate
term
exposure
scenarios.
If
these
label
changes
are
made,
then
the
only
exposure
scenarios
that
still
exceed
the
Agency's
level
of
concern
are
the
following
short
term
postapplication
scenarios
to
turf,
affecting
only
toddlers:
1)
high
contact
dermal
activities
(
MOE
=
660),
incidental
oral
hand
to
mouth
activities
(
MOE
=
860).
Additionally,
the
combined
risk
estimates
for
short
term
postapplication
exposures
to
turf
for
toddlers
also
still
exceed
the
Agency's
level
of
concern;
i.
e.,
for
the
following
combinations:
1)
all
combined
incidental
oral
non
dietary
exposures
to
toddlers
(
except
episodic
ingestion
of
fenarimol
granules)
(
MOE
=
690);
and
2)
combined
dermal
and
all
incidental
oral
non
dietary
exposures
to
toddlers
(
except
episodic
ingestion
of
fenarimol
granules)
(
MOE
=
340).
Aggregate
Risk
Assessment
Based
on
agreements
with
the
registrant
regarding
amendments
to
product
labels
as
described
above,
HED
anticipates
neither
residential
handler
nor
intermediate
term
residential
exposures.
Consequently,
HED
has
not
estimated
aggregate
risks
for
these
scenarios.
Because
several
of
the
risk
estimates
for
short
term
oral
incidental
and
dermal
postapplication
exposures
exceed
HED's
level
of
concern
for
children,
aggregation
of
these
exposures
with
food
and
drinking
water
exposures
would
result
in
risk
estimates
that
further
exceed
HED's
level
of
concern.
HED
has
however
estimated
aggregate
risks
for
chronic
exposures
to
residues
of
fenarimol
in
food
and
drinking
water,
and
for
short
term
postapplication
dermal
food
and
water
exposures
for
adults
golfing.
3
The
reduction
in
the
FQPA
safety
factor
also
affects
the
aggregate
risk
assessment
for
chronic
exposure
to
fenarimol
in
surface
and
ground
water,
resulting
in
increased
drinking
water
levels
of
concern
(
DWLOCs).
Table
1
summarizes
the
changes
in
the
DWLOCs.
Table
1.
Summary
of
Chronic
DWLOC
Calculations
Population
Subgroup
cPAD
(
mg/
kg/
day
)
Food
Exposure
(
mg/
kg/
day)
Available
Water
Exposure
(
mg/
kg/
day)
Chronic
DWLOC
(
g/
L)
EFED
Generated
EECs
(
Chronic)
Surface
Water
(
FIRST)
(
g/
L)
Ground
Water
(
SCI
GROW)
(
g/
L)
U.
S.
Population
a
0.002
0.000000
0.002
70
84
16
Females
13
50
yrs
0.000000
0.002
60
Children
1
6
yrs
b
0.000002
0.001998
20
All
Infants
0.000001
0.001999
20
EEC
=
Estimated
Environmental
Concentrations
for
fenarimol
and
its
aquatic
photodegradates.
NOAEL
(
No
Observable
Adverse
Effect
Level)
=
0.6
mg/
kg/
day
UF
(
Uncertainty
Factor)
=
100
cRfD
(
Chronic
Reference
Dose)
=
NOAEL
=
0.006
mg/
kg/
day
UF
FQPA
SF
(
Food
Quality
Protection
Act
Safety
Factor)
=
3
cPAD
=
Chronic
Population
Adjusted
Dose
=
cRfD
=
0.002
mg/
kg/
day
FQPA
SF
DWLOCchronic
=
water
exposure
X
body
weight
(
where
water
exposure
=
cPAD
average
food
exposure)
Liters
of
water/
day
X10
3
Body
weight
=
70
kg
for
U.
S.
Population,
60
kg
for
females,
10
kg
for
infants
and
children
Consumption
=
2L/
day
for
Adults
and
1L/
day
for
infants
and
children
a
Also
represents
Males
13
19
years,
Males
20+
years,
and
Seniors
55+
b
Also
represents
Children
7
12
years
old.
The
EECs
are
based
on
a
tier
1
model
(
FIRST)
for
a
turf
use
scenario
with
maximum
application
rates.
The
EEC
for
ground
water
is
less
than
all
DWLOCs;
therefore,
there
is
no
concern
for
aggregate
chronic
exposure
to
fenarimol
and
its
degradates
from
food
and
ground
water.
The
EEC
for
surface
water
is
greater
than
all
DWLOCs;
therefore,
there
is
a
potential
concern
for
aggregate
chronic
exposures
to
fenarimol
from
food
and
surface
water.
However,
the
estimated
EEC
for
surface
water
is
a
very
conservative
estimate.
It
represents
the
1
in
10
year
mean
yearly
surface
4
water
concentration.
EFED's
surface
water
modeling
for
drinking
water
uses
a
default
percent
cropped
area
factor
(
PCA)
for
turf,
which
represents
the
fraction
of
the
watershed
that
is
cropped
and
treated
with
the
pesticide
being
modeled.
In
the
absence
of
a
crop
specific
PCA
factor,
a
default
PCA
of
0.87
is
used.
The
0.87
factor
represents
the
maximum
fraction
of
a
watershed
in
the
US
that
is
agriculturally
cropped.
This
default
PCA
was
used
for
fenarimol
modeling
on
turf.
EFED
is
currently
attempting
to
develop
PCA
factors
specific
for
turf
scenarios,
and
recognizes
that
it
is
unlikely
that
87%
of
a
watershed
used
for
drinking
water
would
be
grown
to
turf
and
treated
with
fenarimol
at
the
maximum
rate
allowed
only
for
turf
applications.
The
default
PCA
factor
assumed
and
used
in
fenarimol
modeling
is
most
likely
overestimated
and
adds
to
the
conservatism
of
the
assessment.
Given
the
relatively
low
usage
of
fenarimol
across
the
country
it
is
highly
unlikely
that
the
amount
applied
to
the
watershed
in
the
model
will
be
concentrated
in
any
real
watershed
used
to
derive
drinking
water.
In
summary,
the
surface
water
EEC
is
not
likely
to
underestimate
exposure
to
fenarimol
and
its
degradates
based
on
the
conservative
inputs
to
the
model
(
i.
e.,
default
PCA,
no
decay
via
the
major
degradation
pathway,
and
the
concentrated
application
scenario
modeled
is
unlikely
to
occur
in
a
real
watershed
where
drinking
water
is
derived).
The
uncertainties
related
to
the
aqueous
photoproducts
would
likely
be
addressed
through
completion
of
a
satisfactory
guideline
aqueous
photolysis
study
(
Guidelines
161
2,
835.2240).
Other
uncertainties
would
likely
be
addressed
through
the
satisfactory
completion
of
other
outstanding
guideline
studies;
as
detailed
by
EFED.
Short
term
dermal
postapplication
exposures
for
adults
golfing
were
combined
with
average
dietary
(
food
&
water)
exposures
in
a
short
term
aggregate
risk
assessment.
The
aggregate
risk
estimate
for
the
postapplication
short
term
dermal
exposure
scenario
of
golfing
did
not
exceed
the
Agency's
level
of
concern.
The
exposure
from
food
is
zero
for
adults;
therefore,
the
aggregate
risk
estimates
include
only
dermal
and
water
exposures.
Table
2
presents
the
aggregate
risk
estimates
for
adult
males
and
females,
calculated
using
HED
SOP
99.5.
The
short
term
DWLOCs
for
adults
are
well
above
the
estimated
EECs
for
ground
and
surface
water,
and
indicate
that
combined
short
term
dietary
(
food
&
water)
and
dermal
exposures
do
not
exceed
the
Agency's
level
of
concern.
5
Table
2.
Short
Term
Aggregate
Risk
and
DWLOC
Calculations
(
Oral/
Dermal
Endpoints
and
NOAELs
the
Same)
Population
Short
Term
Scenario
NOAEL
mg/
kg/
day
Target
MOE1
Max
Exposure2
mg/
kg/
day
Average
Food
Exposure
mg/
kg/
day
Residential
Exposure3
mg/
kg/
day
Aggregate
MOE
(
food
and
residential)
4
Max
Water
Exposure5
mg/
kg/
day
Ground
Water
EEC6
(
g/
L)
Surface
Water
EEC6
(
g/
L)
Short
Term
DWLOC7
(
g/
L)
Adult
Male
35
900
0.0388
0.0
0.0026
13460
0.0362
16
84
1267
Adult
Female
35
900
0.0388
0.0
0.0026
13460
0.0362
16
84
1086
1
Target
MOE
=
10x
uncertainty
factor
(
UF)
for
intra
species
variability,
a
10x
UF
for
inter
species
extrapolation,
a
3x
UF
for
lack
of
a
NOAEL
in
the
study
used
as
the
basis
of
the
endpoint,
and
an
FQPA
Safety
Factor
of
3x
2
Maximum
Exposure
(
mg/
kg/
day)
=
NOAEL/
Target
MOE
3
Residential
Exposure
=
Dermal
Exposure
for
Adults
Golfing
4
Aggregate
MOE
=
[
NOAEL
÷
(
Avg
Food
Exposure
+
Residential
Exposure)]
5
Maximum
Water
Exposure
(
mg/
kg/
day)
=
Target
Maximum
Exposure
(
Food
Exposure
+
Residential
Exposure)
6
The
crop
producing
the
highest
level
was
used.
7
DWLOC
(
g/
L)
=
[
maximum
water
exposure
(
mg/
kg/
day)
x
body
weight
(
kg)]
Male
body
weight
=
70
kg;
Female
body
weight
=
60
kg;
water
consumption
=
2
L
[
water
consumption
(
L)
x
10
3
mg/
g]
| epa | 2024-06-07T20:31:43.765546 | regulations | {
"license": "Public Domain",
"url": "https://downloads.regulations.gov/EPA-HQ-OPP-2002-0250-0008/content.txt"
} |
EPA-HQ-OPP-2002-0250-0009 | Supporting & Related Material | "2002-09-24T04:00:00" | null | UNITED
STATES
ENVIRONMENTAL
PROTECTION
AGENCY
WASHINGTON,
D.
C.
20460
OFFICE
OF
PREVENTION,
PESTICIDES
AND
TOXIC
SUBSTANCES
June
7,
2002
MEMORANDUM
SUBJECT:
Fenarimol.
Revised
HED
Human
Health
Assessment
for
the
Tolerance
Reassessment
Eligibility
Decision
(
TRED)
Document.
Chemical
No.
206600.
No
MRID
#.
DP
Barcode
No.
D283429.
FROM:
Barry
O'Keefe,
Residential
Exposure
Assessor/
Risk
Assessor
John
Doherty,
Toxicologist
Danette
Drew,
Chemist
Reregistration
Branch
3
Health
Effects
Division
(
7509C)
THRU:
Catherine
Eiden,
Branch
Senior
Scientist
Reregistration
Branch
3
Health
Effects
Division
(
7509C)
TO:
Tom
Myers,
Chemical
Review
Manager
Special
Review
and
Reregistration
Division
(
7508C)
This
memorandum
and
attachments
are
the
Revised
Health
Effects
Division's
Tolerance
Reassessment
Eligibility
Decision
(
TRED)
Document
for
fenarimol,
taking
into
consideration
comments
from
the
registrant,
Gowan
Company,
and
requirements
of
the
1996
Food
Quality
Protection
Act
(
FQPA).
This
assessment
only
discusses
the
human
health
risk
assessment
required
for
reassessment
of
tolerances
and
does
not
include
an
occupational
risk
assessment
required
for
reregistration
of
products.
Fenarimol
was
registered
after
1984,
so
it
is
not
subject
to
reregistration
under
FIFRA
88.
However,
fenarimol
is
subject
to
tolerance
reassessment
under
the
FQPA.
When
fenarimol
undergoes
product
reregistration,
SRRD
should
insure
that
all
product
labels
are
in
compliance
with
the
worker
protection
standard
(
WPS).
Cumulative
risk
assessment
considering
risks
from
other
pesticides
which
may
have
a
common
mechanism
of
toxicity
is
also
not
addressed
in
this
document.
Attachments:
Hazard
Identification
Assessment
Review
Committee
Revisit
(
HIARC)
report
(
J.
Doherty,
6/
02)
Hazard
Identification
Assessment
Review
Committee
(
HIARC)
report
(
J.
Doherty,
9/
5/
01)
FQPA
Committee
Report
(
B.
Tarplee,
9/
28/
01)
Mechanism
of
Toxicity
Committee
(
METARC)
report
(
J.
Doherty,
9/
17/
01),
Toxicology
Chapter
(
J.
Doherty,
D275392,
10/
12/
01)
Chemistry
Chapter
(
D.
Drew,
D277505,
10/
18/
01)
2
Dietary
Exposure
Analysis
(
D.
Drew,
D278898,
11/
19/
01)
Metabolism
Assessment
Review
Committee
report
(
D.
Drew,
D277692,
9/
17/
01)
Residential
Exposure
Analysis
(
B.
O'Keefe,
D280935,
2/
12/
02)
Drinking
Water
Assessment
to
Support
the
TRED
for
Fenarimol
(
L.
Libelo,
8/
6/
01).
1.0
EXECUTIVE
SUMMARY
Fenarimol
is
a
member
of
the
pyrimidine
class
of
fungicides,
which
also
includes
dimethirimol,
bupirimate,
and
ethirimol.
It
is
the
only
member
of
this
class
registered
for
use
in
the
U.
S.
Fenarimol
is
a
localized
systemic
foliar
fungicide
used
for
control
of
such
pests
as
scab,
powdery
mildew,
rusts,
and
leaf
spot.
Fenarimol
inhibits
fungal
growth
by
adversely
affecting
the
formation
of
the
fungal
sterol
ergosterol.
The
chemical
name
of
fenarimol
is
alpha(
2
chlorophenyl)
alpha(
4
chlorophenyl)
5
pyrimidinemethanol.
Use
Profile
Fenarimol
is
currently
registered
for
use
on
the
following
fruit
and
nut
crops:
apples,
cherries,
filberts,
grapes,
pears,
bananas
and
pecans.
It
is
also
registered
for
use
on
ornamental
plants,
trees,
grasses,
and
turf.
The
registration
of
fenarimol
is
being
supported
by
Gowan
Company.
Fenarimol
total
domestic
usage
for
years
1990
1999
averaged
approximately
61,000
pounds
active
ingredient.
Its
largest
markets,
in
terms
of
total
pounds
active
ingredient
(
ai),
are
allocated
to
apples
(
33%),
outdoor
nurseries
(
20%),
turf
for
lawns
(
16%),
and
turf
for
golf
courses
(
12%).
The
remaining
usage
is
primarily
on
raisin
and
wine
grapes,
cherries,
filberts,
and
pears.
Crops
with
a
high
percentage
of
the
total
U.
S.
planted
acres
treated
include
apples
(
25%),
raisin
grapes
(
21%),
sweet
cherries
(
13%),
tart
cherries,
wine
grapes,
and
filberts
(
9%
each),
and
table
grapes
(
8%).
Fenarimol
formulations
include
granular
(
0.78%
ai,
turf
use
only),
soluble
concentrate/
liquid
(
11.6%
ai),
flowable
concentrate
(
2.4%
ai)
and
emulsifiable
concentrates
(
11.6%
ai
and
12%
ai).
Only
applications
to
lawns
and
turf
are
expected
to
result
in
residential
exposures.
Although
some
end
use
products
have
label
restrictions
and
wording
indicative
of
non
homeowner
use,
fenarimol
is
not
a
restricted
use
pesticide
and
can
be
purchased
and
applied
by
anyone.
However,
only
the
granular
formulation
is
assumed
to
be
applied
by
residents.
However,
due
to
communications
with
the
Agency,
Riverdale
Chemical
Company,
the
registrant
of
this
granular
product,
has
agreed
to
change
the
label
to
prohibit
the
sale
to
and
use
by
homeowners
of
the
granular
product.
Hazard
Identification
and
Dose
Response
Assessment
The
toxicity
database
for
fenarimol
is
substantially
complete,
with
the
following
data
gaps
identified:
Primary
Dermal
Irritation
Study
(
870.2400);
28
Day
Subchronic
Inhalation
Study
(
870.3465);
and
Special
Developmental
Study
(
870.6300).
Fenarimol
has
moderate
acute
toxicity
via
the
oral,
dermal
or
inhalation
routes
(
all
Category
III).
Fenarimol
causes
corneal
opacity
in
rabbit
eyes
(
Category
II).
There
are
no
data
on
dermal
irritation.
Fenarimol
was
not
shown
to
be
a
contact
dermal
sensitizer
in
the
guinea
pig.
The
rat
metabolism
study
indicates
that
following
oral
administration,
fenarimol
is
rapidly
absorbed
3
and
excreted,
with
the
biliary
route
being
the
major
route
of
excretion.
Subchronic
oral
dosing
in
rats
demonstrates
very
little
toxicity
except
for
some
slight
body
weight
changes
and
liver
pathology
of
low
degree
and
consistency
(
liver
weight
increase
and
fatty
liver).
In
dogs,
there
was
little
overt
toxicity.
Dermal
absorption
was
estimated
by
HIARC
(
9/
6/
01)
to
be
20%
based
on
a
weight
of
the
evidence
assessment
using
rabbit
and
monkey
dermal
absorption
studies
along
with
a
comparison
of
the
rabbit
oral
developmental
toxicity
and
rabbit
21
day
dermal
toxicity
studies.
However,
based
on
additional
data
supplied
by
the
registrant
(
Gowan
Company),
the
HIARC
(
5/
23/
02)
determined
that
a
dermal
absorption
rate
estimate
of
5%
was
more
appropriate
for
risk
assessment
purposes.
The
liver
is
the
most
evident
target
organ
for
chronic
toxicity,
aside
from
the
effects
of
fenarimol
on
aromatase.
Liver
toxicity
was
manifested
by
liver
weight
increases
and
the
presence
of
"
fatty
liver"
in
rats.
In
dogs,
liver
weight
was
increased
and
there
were
also
increases
in
serum
enzymes
indicative
of
liver
toxicity.
The
data
base
for
carcinogenicity
is
considered
complete.
Fenarimol
has
been
classified
as
a
"
not
likely"
human
carcinogen
(
Group
E).
The
mutagenicity/
genetic
toxicity
data
base
is
considered
complete
and
indicates
no
mutagenicity
concern.
The
data
base
for
prenatal
developmental
and
reproductive
toxicity
is
considered
complete.
The
developmental
and
reproductive
toxicity
studies
showed
no
evidence
of
increased
sensitivity
or
susceptibility
of
young
rats
or
rabbits
following
pre
or
postnatal
exposure
to
fenarimol.
The
studies
demonstrated
that
fenarimol
is
associated
with
hydronephrosis
that
is
reversible.
The
most
prominent
aspect
of
fenarimol
toxicity
was
evident
in
the
rat
multi
generation
reproduction
studies
and
relates
to
inhibition
of
aromatase.
Aromatase,
also
known
as
estrogen
synthetase,
is
the
key
enzyme
for
the
conversion
of
androgens
to
estrogens
and
is
therefore
a
potentially
critical
enzyme
in
maintaining
hormone
balance
in
human
physiology.
Without
aromatase,
there
could
potentially
be
deficits
in
estrogens
which
are
important
for
a
variety
of
physiological
functions.
Estrogens
are
largely
responsible
for
the
changes
that
take
place
during
puberty
in
human
females
and
affect
secondary
sexual
characteristics.
It
is
also
recognized
that
aromatase
deficient
males
do
not
develop
normal
skeletal
characteristics.
The
Mechanism
of
Toxicity
Assessment
Review
Committee
(
METARC)
met
to
evaluate
the
data
concerning
fenarimol's
effects
on
aromatase
and
their
decision
memorandum
contains
a
more
detailed
discussion
of
aromatase
(
J.
Doherty,
9/
16/
01).
The
multi
generation
reproduction
studies
indicate
that
fenarimol
causes
reduced
fertility
and
dystocia
(
difficult
labor).
Separate
cross
dosing
studies
(
dosing
males
and
mating
with
untreated
females
and
dosing
females
and
mating
with
untreated
males)
indicated
that
the
reduced
fertility
is
due
to
an
effect
in
males
and
the
dystocia
is
an
effect
in
females.
These
effects
of
fenarimol
were
demonstrated
to
be
attributed
to
inhibition
of
aromatase
in
adult
animals.
The
decrease
in
fertility
in
males
results
from
the
decreased
conversion
of
testosterone
(
an
androgen)
to
estradiol
which
is
essential
for
male
sexual
development.
The
increase
in
dystocia
in
rats
was
also
attributed
to
inhibition
of
aromatase
because
in
the
rat,
progesterone
is
converted
to
estrogen
by
aromatase
to
facilitate
parturition
(
birth).
The
FQPA
required
the
Agency
to
consider
potential
special
sensitivity
to
infants
and
children
from
exposure
to
fenarimol.
Submitted
toxicity
studies
showed
that
there
is
no
increased
sensitivity
or
susceptibility
to
infants
and
children
based
mainly
on
the
results
of
the
developmental/
reproductive
toxicity
studies.
However,
a
special
developmental
study
is
required
to
determine
if
the
potential
hormonal
effects
as
elicited
by
inhibition
of
aromatase
will
result
in
effects
in
offspring.
Additionally,
4
the
environmental
fate
database
is
incomplete
for
the
aquatic
photolytic
degradate
of
fenarimol,
4
chloro
2(
5
pyrimidyl)
2'
chlorobenzophenone.
A
screening
level
drinking
water
assessment,
which
includes
this
degradate
of
potential
toxicological
concern,
is
not
possible
at
this
time.
Therefore,
the
FQPA
committee
determined
that
the
10x
FQPA
factor
should
be
retained
for
all
fenarimol
risk
assessments.
The
METARC
recommended,
and
the
HIARC
confirmed,
that
the
reduced
male
fertility
and
dystocia
effects
of
fenarimol
should
be
endpoints
for
human
health
risk
assessment.
It
is
noted
that
the
endpoint
from
the
multi
generation
reproduction
study
is
based
on
decreased
litter
size.
This
decrease
in
litter
size
may
be
a
reflection
of
the
maternal
toxicity
(
dystocia)
or
the
potential
for
fenarimol
to
inhibit
aromatase
in
males
(
reduced
fertility).
Because
both
males
and
females
are
affected,
the
toxicological
endpoint
from
the
multi
generation
reproduction
study
is
applicable
to
all
populations.
After
examining
all
of
the
available
toxicity
data,
the
HIARC
concluded
that
an
acute
toxicity
endpoint
and
dose
for
risk
assessment
could
not
be
identified.
That
is,
no
appropriate
endpoint
was
available
to
quantitate
risk
to
the
general
population
or
females
13
50
years
old
from
a
single
dose
administration
of
fenarimol.
Although
hydronephrosis
seen
in
the
rat
developmental
and
multigeneration
reproductive
toxicity
studies
had
been
identified
as
an
acute
adverse
toxic
effect
(
endpoint)
in
earlier
fenarimol
risk
assessments,
the
HIARC
concluded
that
it
is
not
appropriate
because:
1)
the
hydronephrosis
is
not
severe
(
its
is
considered
an
effect
of
low
degree
or
magnitude);
2)
the
hydronephrosis
was
shown
to
be
reversible;
3)
the
hydronephrosis
developed
after
multiple
exposures
and
there
is
no
indication
that
it
would
develop
following
a
single
exposure;
and,
4)
the
hydronephrosis
may
be
related
to
a
developmental
delay
and
not
a
target
specific
effect
of
fenarimol.
For
risks
associated
with
chronic
dietary
exposures,
the
HIARC
identified
a
reference
dose
for
chronic
exposure
(
cRfD)
of
0.006
mg/
kg/
day
from
the
multi
generation
reproduction
study
based
on
a
no
observed
adverse
effect
level
(
NOAEL)
of
0.6
mg/
kg/
day,
and
a
10X
uncertainty
factor
for
interspecies
extrapolation
and
a
10X
uncertainty
factor
for
intraspecies
variation.
The
NOAEL
of
0.6
mg/
kg/
day
is
based
on
decreased
live
born
litter
size
in
the
F
1
and
F
2
generations
at
a
lowest
observed
adverse
effect
level
(
LOAEL)
of
1.2
mg/
kg/
day.
HED
calculated
a
chronic
Population
Adjusted
Dose
(
cPAD)
of
0.0006
mg/
kg/
day.
The
cPAD
is
the
RfD
divided
by
the
FQPA
safety
factor
(
10X).
Chronic
dietary
exposure
estimates
greater
than
100%
of
the
cPAD
would
exceed
HED's
level
of
concern.
For
risks
associated
with
intermediate
term
residential
exposures
(
1
6
months),
the
same
endpoint
(
NOAEL
of
0.6
mg/
kg/
day)
was
used
for
incidental
oral,
dermal,
and
inhalation
risk
assessments.
A
Margin
of
Exposure
or
MOE,
which
is
the
ratio
of
the
NOAEL
to
the
exposure
estimate,
of
greater
than
or
equal
to1000
does
not
exceed
HED's
level
of
concern
for
intermediate
term
risk
assessments.
A
MOE
of
greater
than
or
equal
to1000
is
required
for
these
intermediate
term
exposure
scenarios
because
of
the
10x
interspecies
factor,
the
10x
intraspecies
factor
and
the
10x
FQPA
factor.
Because
the
same
endpoint
was
used
for
all
intermediate
term
exposure
assessments,
the
risk
estimates
for
the
various
routes
of
exposure
may
be
aggregated.
For
the
short
term
(
1
30
day)
incidental
oral,
dermal,
and
inhalation
risk
assessments,
a
LOAEL
of
35
mg/
kg/
day
was
selected.
This
endpoint
is
based
on
decreased
fertility
and
dystocia,
an
indicator
of
5
hormonal
effects,
observed
in
a
special
non
guideline
cross
breeding
reproduction/
developmental
toxicity
study
in
rats.
Because
a
NOAEL
could
not
be
identified
in
the
study,
and
effects
were
seen
at
the
lowest
dose
tested,
a
LOAEL
was
used,
and
is
used
an
additional
3x
uncertainty
factor
was
applied.
Therefore,
a
MOE
greater
than
3000
does
not
exceed
HED's
level
of
concern
for
short
term
risk
assessments.
Because
the
same
endpoint
was
used
for
all
short
term
exposure
assessments,
the
risk
estimates
for
the
various
routes
of
exposure
may
be
aggregated.
Exposure
and
Risk
Assessment
Dietary
Exposure
and
Risk
Estimates
The
residue
chemistry
database
for
fenarimol
is
substantially
complete
and
is
adequate
for
tolerance
reassessment.
The
Metabolism
Assessment
Review
Committee
(
MARC)
has
determined
that
for
enforcement
purposes,
the
tolerance
for
plant
commodities
should
be
expressed
as
parent
only.
However
the
dietary
assessment
for
grapes
and
bananas
should
include
the
metabolites
[
alpha(
2
chlorophenyl)
alpha(
4
chlorophenyl)
1,4
dihydro
5
pyrimidinemethanol]
and
(
5[
2
chlorophenyl)
(
4
chlorophenyl)
methyl]
3,4
dihydro
4
pyrimidinol]),
because
of
their
structural
similarity
to
fenarimol.
The
residue
of
concern
in
livestock
commodities
is
fenarimol
per
se.
Tolerances
for
fenarimol
are
generally
low,
ranging
from
0.01
to
1.0
ppm
Because
an
acute
toxicity
endpoint
was
not
identified,
an
acute
dietary
exposure
assessment
was
neither
required
nor
conducted.
The
chronic
dietary
exposure
assessment
for
fenarimol
is
highly
refined
using
anticipated
residues
based
on
Food
and
Drug
Administration
(
FDA)
monitoring
data
for
apples,
bananas,
cherries,
grapes
and
pears.
There
were
no
USDA
Pesticide
Data
Program
(
PDP)
monitoring
data
available
for
fenarimol.
The
FDA
monitoring
data
indicated
no
detectable
residues
for
apples,
bananas,
grapes
and
pears.
Field
trial
residue
data
were
used
for
pecans
and
filberts.
Percent
crop
treated
(%
CT)
information
and
processing
factors,
where
available,
were
used
in
the
assessment.
Anticipated
residues
were
calculated
for
cattle
meat,
fat,
and
meat
by
products.
Wet
apple
pomace
is
the
only
animal
feed
item
associated
with
the
registered
uses
of
fenarimol.
There
are
no
poultry
or
hog
feedstuffs.
Milk
was
classified
as
Category
3
of
40
CFR
180.6(
a)
that
is,
there
is
no
reasonable
expectation
of
finite
residues.
Chronic
dietary
risk
estimates
are
provided
for
the
general
U.
S.
population
and
various
population
subgroups.
This
assessment
concludes
that
for
all
supported
registered
commodities,
the
chronic
risk
estimates
are
below
the
HED's
level
of
concern
(<
100%
of
the
chronic
population
adjusted
dose,
cPAD)
for
the
general
U.
S.
population
and
all
population
subgroups.
Dietary
(
food)
exposure
estimates
were
all
very
low
(
all
<
1%
of
the
cPAD).
This
is
not
surprising
based
on:
the
lack
of
detectable
residues
for
many
commodities
in
the
FDA
monitoring
data;
no
residues
expected
in
milk,
poultry
and
hogs;
and,
low
anticipated
residues
for
cattle
meat,
fat,
and
meat
by
products.
Environmental
fate
data
show
that
fenarimol
is
persistent
and
mobile
in
the
environment.
In
field
studies,
fenarimol
dissipated
with
half
lives
of
3
months
to
several
years
from
soil
and
turf
surfaces.
Fenarimol
is
stable
to
hydrolysis,
anaerobic
microbial
degradation
and
photolysis
on
soil.
It
is
degraded
very
slowly,
if
at
all,
by
aerobic
microbial
processes
with
reported
mean
aerobic
soil
metabolism
half
life
of
about
4
years.
It
is
degraded
by
photolysis
in
aqueous
solution.
The
primary
photolysis
product
was
4
chloro
2(
5
pyrimidyl)
2'
clorobenzophenone.
The
MARC
elected
not
to
exclude
this
degradate
in
the
drinking
water
exposure
assessment
because:
1)
its
potential
to
occur
in
surface
water;
and
2)
the
lack
of
data
to
determine
whether
it
is
of
toxicological
concern.
6
The
environmental
fate
studies
were
conducted
in
the
1970s
and
early
1980s.
The
quality
of
the
data
provided
by
these
studies
is
significantly
lower
then
currently
required.
By
current
standards
most
of
these
studies
would
not
be
considered
acceptable
and
the
results
would
not
be
considered
of
sufficient
quality
to
allow
a
reasonably
accurate
assessment
of
the
environmental
fate
of
this
compound.
Therefore,
the
estimated
environmental
concentrations
(
EECs)
presented
here
are
somewhat
uncertain,
and
may
change
substantially
when
better
data
become
available.
It
is
not
possible,
using
the
existing
data,
to
provide
a
more
refined
assessment.
To
estimate
risks
from
exposure
to
fenarimol
residues
potentially
present
in
drinking
water,
HED
has
compared
EECs
for
fenarimol
in
surface
water
and
groundwater
to
calculated
drinking
water
levels
of
comparison
(
DWLOCs).
The
DWLOC
chronic
is
the
concentration
in
drinking
water
as
a
part
of
the
aggregate
chronic
exposure
that
occupies
no
more
than
100%
of
the
cPAD
when
considered
together
with
other
sources
of
exposure.
If
the
EECs
are
greater
than
the
DWLOCs,
there
is
a
potential
drinking
water
concern.
Screening
level
assessments,
using
conservative
modeling
to
estimate
highend
average
concentrations
(
EECs)
of
fenarimol
in
surface
water
and
groundwater,
were
conducted
by
the
Environmental
Fate
and
Effects
Division
(
EFED).
Tier
I
modeling
was
performed
for
both
surface
water
(
FIRST
model)
and
groundwater
(
SCI
GROW
model).
EFED
modeled
the
turf
application
use
scenario
in
both
cases.
A
Tier
II
model
is
not
available
for
turf.
Upon
comparison
of
the
chronic
DWLOCs
with
the
chronic
EECs,
average
concentrations
of
fenarimol
in
surface
and
groundwater
are
greater
than
the
DWLOCs
for
several
populations.
For
surface
water,
EECs
were
approximately
three
(
children
1
6
yrs
and
all
infants)
to
ten
(
females
13
50
yrs
and
the
general
U.
S.
population)
times
higher
than
the
DWLOC
chronic.
For
those
populations
with
ground
water
EECs
greater
than
the
DWLOC
chronic,
the
EECs
were
approximately
two
times
higher
than
the
DWLOCs.
Consequently,
there
is
a
potential
concern
for
chronic
exposure
through
drinking
water
from
surface
water
sources
for
all
populations,
and
for
infants
and
children
from
groundwater
sources.
Residential
Exposure
and
Risk
Estimates
Potential
residential
exposures
may
occur
as
a
result
of
applications
of
fenarimol
to
residential
lawns
or
turf
by
residents
and
by
professional
lawn
care
operators
(
LCOs).
Residential
exposures
have
been
estimated
based
on
label
application
rates
and
frequency,
and
the
persistence
of
fenarimol.
The
following
use
patterns
have
been
assessed
for
non
occupational
(
residential)
handler
exposures:
1)
granular
application
to
turf
with
a
belly
grinder
spreader;
2)
granular
application
to
turf
with
a
pushtype
spreader;
and
3)
granular
spot
treatment
to
turf
by
hand.
The
short
term
risks
to
residential
handlers
were
assessed
using
the
updated
draft
Standard
Operating
Procedures
(
SOPs)
for
Residential
Exposure
Assessment,
and
includes
surrogate
data
from
the
Pesticide
Handlers
Exposure
Database
(
PHED)
for
loading/
applying
with
a
belly
grinder
type
granular
spreader
and
applying
by
hand,
and
the
Outdoor
Residential
Exposure
Task
Force
(
ORETF)
for
loading/
applying
with
a
push
type
granular
spreader.
The
ORETF
data
are
recent
high
quality
studies.
The
data
used
for
the
hand
dispersal
and
belly
grinder
type
granular
spreader
are
not
as
high
quality.
Central
tendency
exposure
data
were
used
together
with
the
label
maximum
rate
for
short
term
exposures,
so
the
assessment
is
considered
protective
for
most
uses,
but
not
conservative.
For
residential
adult
handlers
applying
granular
product
to
turf,
risk
estimates
for
short
term
dermal
exposures
exceed
HED's
level
of
concern
(
MOEs
are
less
than
3000)
for
the
application
by
a
belly
grinder
type
spreader
(
MOE
=
280)
or
by
hand
dispersal
for
spot
treatments
(
MOE
=
1600).
However,
for
the
other
short
term
handler
exposures
to
fenarimol
(
using
a
push
type
spreader),
HED's
level
of
concern
is
not
exceeded,
i.
e.
all
risk
estimates
(
MOEs)
are
3000
or
greater.
Note:
If
7
label
restrictions
prohibiting
sale
to
or
use
by
homeowners
of
the
granular
product,
as
agreed
to
by
the
registrant,
are
implemented,
then
these
homeowner
handler
scenarios
should
not
occur.
Several
post
application
exposure
scenarios
following
application
to
turf
are
anticipated;
these
are
as
follows:
1)
short
term
(
1
30
days)
and
intermediate
term
(
30
days
to
6
months)
dermal
exposure
to
adults
and
children
(
toddlers);
2)
incidental
episodic
oral
exposure
to
children
from
ingestion
of
fenarimol
granules;
and
3)
short
and
intermediate
term
oral
exposure
to
children
from
incidental
ingestion
of
soil,
turf
grass
mouthing,
and
hand
to
mouth
activity.
These
exposures
could
occur
whether
a
professional
or
resident
applied
fenarimol.
The
updated
Residential
SOPs
were
used
to
address
the
exposures
of
children
contacting
treated
turf.
The
SOPs
for
turf
use
a
high
contact
activity
based
on
the
use
of
Jazzercise
®
to
represent
the
exposures
of
an
actively
playing
child
or
active
adult.
Lower
contact
activities,
such
as
walking,
mowing,
or
golfing,
for
example,
use
transfer
coefficients
based
on
mowing
studies.
Chemical
specific
data
from
a
turf
transferable
residue
(
TTR)
study
were
available
and
were
used
to
estimate
the
dissipation
of
fenarimol.
Dislodgeable
foliar
residue
(
DFR)
data
were
also
available
for
apple
trees.
These
apple
DFR
data
support
the
EFED
conclusions
concerning
the
persistence
of
fenarimol
in
the
environment.
In
the
DFR
study,
detectable
residues
were
still
present
on
leaf
surfaces
65
days
after
treatment.
Risk
estimates
for
short
term
dermal
contact
with
treated
turf
during
high
contact
lawn
activities
on
day
zero
following
application
exceed
HED's
estimated
level
of
concern
for
adults
and
toddlers
(
MOEs
of
950
and
660,
respectively).
For
low
contact
activities
(
such
as
grass
mowing
or
golfing
),
MOEs
were
3000
or
greater
and
did
not
exceed
the
level
of
concern.
Risk
estimates
for
intermediateterm
dermal
contact
with
treated
turf
MOEs
were
1000
or
greater
and
did
not
exceed
the
level
of
concern
for
high
contact
lawn
activities
(
MOE
of
1400
for
adults,
1000
for
toddlers).
Risk
estimates
for
adults
were
well
below
the
level
of
concern
for
the
low
contact
activities
of
golfing
and
mowing,
with
all
MOEs
10,000.
HED
assessed
short
term
exposures
of
small
children
following
application
of
fenarimol
to
residential
lawns,
including
exposures
from
incidental
episodic
ingestion
of
fenarimol
granules,
and
exposures
from
incidental
ingestion
of
fenarimol
residues
from
turf
grass
mouthing,
hand
to
mouth
activity,
and
soil
ingestion.
The
risk
estimates
for
small
children's
ingestion
of
fenarimol
from
treated
turf
indicate
that
risks
exceed
the
level
of
concern
(
MOEs
less
than
3000)
for
ingestion
of
granules
(
MOE
=
220)
and
hand
to
mouth
(
MOE
=
860)
activity.
However,
HED
considers
the
incidental
episodic
risk
of
ingestion
of
fenarimol
granules
to
be
unlikely
given
the
smaller
particle
size
of
fenarimol
granules
and
the
fact
that
watering
in
should
occur
immediately
or
soon
after
application
in
order
for
the
pesticide
to
be
efficacious.
Incidental
ingestion
of
soil
and
incidental
turf
grass
mouthing
did
not
exceed
the
level
of
concern.
The
small
children's
combined
oral
hand
to
mouth
scenarios
(
except
granular
ingestion)
also
exceeds
the
level
of
concern
(
MOE
=
690).
When
risk
estimates
for
small
children
from
short
term
dermal
exposures
are
combined
with
risk
estimates
from
short
term
incidental
oral
exposures
(
except
granular
ingestion),
the
combined
short
term
MOE
exceeds
the
level
of
concern
(
MOE
=
340).
Based
upon
the
slow
dissipation
rate
of
fenarimol
and
the
possibility
of
multiple
applications
to
turf,
HED
estimated
risks
for
intermediate
term
exposures
of
small
children
from
incidental
ingestion
of
soil,
hand
to
mouth
transfer,
and
incidental
turf
grass
mouthing.
Intermediate
term
risk
estimates
were
below
the
level
of
concern
for
ingestion
of
soil
(
MOE
=
24,000).
However,
the
intermediate
8
N
N
OH
Cl
Cl
term
risk
estimates
for
the
turf
grass
mouthing
(
MOE
=
320)
and
hand
to
mouth
activities
(
MOE
=
78)
exceed
the
level
of
concern.
The
small
children's
combined
oral
hand
to
mouth
scenarios
(
except
granular
ingestion)
also
exceed
the
level
of
concern
(
MOE
=
62).
When
risks
from
dermal
exposures
from
fenarimol
to
small
children
are
combined
with
risks
from
incidental
oral
exposures,
the
combined
intermediate
term
risk
estimates
exceed
the
level
of
concern
(
MOE
=
58).
These
intermediate
term
incidental
risk
estimates
do
not
account
for
the
fact
that
turf
periodically
receives
irrigation
and/
or
precipitation
and
is
routinely
mowed
resulting
in
the
removal
of
grass
and
residues,
and
therefore,
may
overestimate
exposure.
Additionally,
the
assumption
that
toddlers
will
play
on
turf
for
two
hours
per
day,
for
more
than
30
consecutive
days,
may
be
a
conservative
assumption.
Therefore,
intermediate
term
risks
to
toddlers
playing
on
turf
may
not
be
as
great
of
a
concern
as
the
risk
estimates
indicate.
Mitigating
circumstances
for
residential
exposure
to
fenarimol
residues
may
include
watering
in
after
application
to
turf.
This
instruction,
however,
does
not
prevent
contact
with
treated
turf
prior
to
watering
in.
The
current
granular
label
(
EPA
Reg.
No.
228
298)
recommends,
but
does
not
require
watering
in.
The
soluble
concentrate
label
(
EPA
Reg.
No.
62719
142)
does
not
mention
watering
in.
Therefore,
label
language
should
be
strengthened
to
ensure
that
watering
in
occurs
immediately
after
application.
Additionally,
the
current
labeling
does
not
clearly
specify
whether
the
granular
product
(
EPA
Reg.
No.
228
298)
is
for
professional
use
only.
Specific
labeling
would
help
eliminate
unintentional
use
by
residents.
Labeling
should
also
specifically
advise
against
the
hand
dispersal
and
belly
grinder
type
application
methods.
Note:
If
label
restrictions
prohibiting
sale
to
or
use
by
homeowners,
as
agreed
to
by
the
registrant
of
the
granular
product,
are
implemented,
then
these
homeowner
handler
scenarios
should
not
occur.
Aggregate
Exposure
and
Risk
Estimates
Because
no
acute
toxicity
endpoint
was
identified
for
risk
assessment,
an
aggregate
acute
risk
assessment
was
not
conducted.
Short
and
intermediate
term
aggregate
risk
estimates
exceed
HED's
level
of
concern.
These
risk
assessments
consider
residential
as
well
as
dietary
(
food
and
water)
exposures.
Because
risk
estimates
for
the
residential
uses
alone
exceed
HED's
level
of
concern,
additional
exposure
from
food
or
drinking
water
would
only
cause
risk
estimates
to
further
exceed
the
level
of
concern.
Chronic
aggregate
risk
estimates
also
exceed
HED's
level
of
concern.
Although
chronic
dietary
(
food)
estimates
are
low
(<
1%
of
the
cPAD),
EECs
for
ground
water
and
surface
water
exceed
DWLOCs
for
several
population
subgroups.
2.0
PHYSICAL
CHEMICAL
PROPERTIES
CHARACTERIZATION
The
chemical
name
for
fenarimol
is
alpha(
2
chlorophenyl)
alpha(
4
chlorophenyl)
5
pyridinemethanol.
The
structure
is
as
follows:
9
Empirical
Formula:
C
17
H
12
Cl
2
N
2
O
Molecular
Weight:
331.2
CAS
Registry
No.:
60168
88
9
PC
Code:
206600
Fenarimol
is
a
white
to
buff
crystalline
solid
with
a
melting
point
of
117
119
C,
bulk
density
of
0.66
0.81
g/
cc
(
packed),
octanol/
water
partition
coefficient
(
log
K
ow)
of
3.69,
and
vapor
pressure
of
2.2
x
10
7
Torr
at
25
C.
Fenarimol
is
practically
insoluble
in
water
(
13.7
ppm
at
pH
7
and
25
C)
and
is
soluble
in
most
organic
solvents:
hexane
(
1.1
mg/
mL);
acetonitrile,
heavy
aromatic
naphtha,
and
xylene
(
50
mg/
mL);
benzene
and
methanol
(
100
125
mg/
mL);
acetone
(>
250
mg/
mL);
and
chloroform
and
cyclohexanone
(>
500
mg/
mL).
3.0
HAZARD
CHARACTERIZATION
3.1
Hazard
Profile
Toxicology
data
are
used
by
HED
to
assess
the
potential
hazards
to
humans.
The
data
are
derived
from
a
variety
of
acute,
subchronic,
and
chronic
toxicity
tests;
developmental/
reproductive
tests;
and
tests
to
assess
mutagenicity
and
pesticide
metabolism.
The
database
for
fenarimol
is
adequate
to
support
this
TRED.
Acute
toxicity
values
and
toxicity
categories
for
fenarimol
are
summarized
in
Table
1.
The
data
indicate
that
fenarimol
has
low
acute
oral,
dermal,
and
inhalation
toxicity
(
category
III).
Fenarimol
is
category
II
with
respect
to
ocular
irritation.
It
is
not
a
dermal
sensitizer.
A
primary
dermal
irritation
study
is
not
available.
Table
1.
Acute
Toxicity
of
Fenarimol.
Study
Type
MRID
No.:
Result
870.1100
Acute
Oral
Toxicity
rat.
Elanco,
Study
No.:
R
O
289
82,
December
30,
1982
00125392
LD50
>
599
mg/
kg.
Toxicity
Category
III
Classification:
Guideline
Study
Type
MRID
No.:
Result
10
870.1200
Acute
Dermal
Toxicity
rabbit.
Elanco
Study
No.:
B
D
27
82,
February
17,
1983
00125392
LD50
>
1998
mg/
kg.
Toxicity
Category
III
Classification:
Minimum
870.1300.
Acute
Inhalation
Toxicity
rat.
Elanco,
Study
No.:
R
H
102
82,
November
16,
1982.
00125292
LC50
>
5.20
mg/
L
for
males.
LC50
between
2.87
and
5.2
mg/
L
for
females.
Toxicity
Category
III
Classification:
Guideline
870.2400
Primary
Ocular
Irritation
Rabbit.
Elanco,
Study
No.:
B
E
32
82,
February
1,
1982
00125392
Day
1:
6/
6
corneal
opacity
(
score
of
5);
5/
6
iris
irritation
(
score
5);
6/
6
conjunctival
irritation
(
score
of
1
2).
Day
7:
3/
6
corneal
opacity
and
conjunctival
irritation.
Day
14
all
irritation
cleared.
Toxicity
Category
II
Classification:
Minimum
870.2500
Primary
Dermal
Irritation
rabbit.
No
study
available.
870.2600
Dermal
Sensitization
guinea
pig.
Elanco,
Study
No.;
GP
9538,
January
1,
1980.
00084966
No
evidence
of
sensitization
in
the
Guinea
Pig
Maximization
test
of
Magnusson
and
Kligman.
Classification:
Minimum.
Table
2
presents
a
summary
of
subchronic
and
chronic
toxicity
studies
for
fenarimol.
Subchronic
oral
dosing
in
rats
demonstrates
very
little
toxicity
except
for
some
slight
body
weight
changes
and
liver
pathology
of
low
degree
and
inconsistency.
In
dogs
there
was
also
little
overt
toxicity
with
there
being
some
effects
in
the
liver.
A
28
day
subchronic
inhalation
study
is
required.
The
Gowan
Company
requested
that
the
Agency
rescind
the
data
requirement
for
the
28
day
inhalation
study.
They
disagree
on
its
need
and
cite
that
this
issue
was
addressed
recently
by
CropLife
America,
an
industrial
organization.
They
also
stated
that
the
sprays
that
will
typically
result
from
fenarimol
use
will
have
droplets
that
will
be
tens
or
thousands
of
micrometers
in
diameter
or
much
larger
than
the
respirable
droplets
of
a
few
micrometers
in
diameter.
These
larger
droplets
will
not
reach
the
alveoli
and
will
become
trapped
in
the
upper
respiratory
tract
and
eventually
swallowed.
Thus,
they
contended
that
the
endpoint
from
an
oral
toxicity
study
is
a
more
appropriate
endpoint.
In
a
written
response
to
comments
(
5/
8/
02),
the
HED
stated
there
have
been
some
recent
changes
in
HED
policy
regarding
the
need
for
subchronic
inhalation
toxicity
studies.
The
comments
of
the
CropLife
America
organization
have
been
taken
into
consideration
at
a
recent
presentation
to
the
Agency.
As
a
result
of
these
recent
changes,
the
Gowan
Company
may
submit
a
waiver
for
the
28
day
inhalation
study.
This
waiver
must
contain
sufficient
data
on
the
particle
size
of
the
sprays
and
other
preparations
that
may
result
in
inhalation
exposure.
It
also
must
contain
sufficient
other
information
regarding
the
potential
inhalation
exposure
such
as
duration
of
exposure
in
terms
of
hours
per
day,
per
week,
etc.
The
completed
waiver
request
will
be
presented
to
a
peer
review
committee
that
will
determine
the
need
for
the
subchronic
inhalation
toxicity
study.
This
peer
review
group
will
consist
of
toxicologists
with
expertise
in
inhalation
toxicology
as
well
as
occupational
and
residential
exposure
representatives.
The
decision
on
the
need
for
the
subchronic
inhalation
toxicity
study
will
be
based
on
all
relevant
factors.
The
more
complete
the
information
in
the
waiver
request
is,
the
better
the
chance
for
the
waiver
to
be
granted.
The
limited
information
provided
in
the
April
10,
2002
letter
is
not
sufficient
11
to
bring
to
a
peer
review
committee
to
consider
a
waiver
for
an
inhalation
toxicity
study.
Lastly,
the
HED
is
already
using
an
oral
toxicity
endpoint
for
the
inhalation
exposure
scenarios.
However,
the
subchronic
inhalation
toxicity
study
is
considered
more
appropriate
for
risk
assessment
based
on
inhalation
exposures.
Adequate
data
are
available
to
assess
the
chronic
toxicity
and
carcinogenic
potential
of
fenarimol.
The
liver
appears
to
be
the
most
evident
target
organ
for
chronic
toxicity
aside
from
the
effects
of
fenarimol
on
aromatase.
Liver
toxicity
was
manifested
by
liver
weight
increases
and
the
presence
of
"
fatty
liver"
in
rats.
In
dogs,
liver
weight
was
increased
and
there
was
also
associated
increases
in
serum
enzymes
to
indicate
liver
toxicity.
p
Nitroanisole
o
demethylase
was
also
increased
indicating
stimulation
of
liver
enzymes.
Fenarimol
has
been
classified
as
a
Group
E
"
not
likely"
carcinogen
(
no
evidence
of
carcinogenicity
for
humans).
Similarly,
the
genetic
toxicity
data
indicate
there
is
no
mutagenicity
concern.
Developmental
studies
in
rats
and
rabbits,
designed
to
identify
possible
adverse
effects
on
the
developing
organism
which
may
result
from
the
in
utero
exposure
to
the
pesticide
were
also
conducted.
The
data
base
for
prenatal
developmental
toxicity
is
considered
complete.
The
initial
guideline
study
was
classified
as
unacceptable,
but
this
study
together
with
a
special
study
to
assess
for
the
reversibility
of
hydronephrosis
are
combined
with
another
special
study
to
assess
for
reproductive
performance.
All
of
these
studies
combine
to
make
an
acceptable
study
and
to
satisfy
the
guideline
requirement.
The
rat
studies
revealed
that
fenarimol
is
associated
with
hydronephrosis
that
is
reversible.
The
developmental
toxicity
studies
showed
no
evidence
of
increased
sensitivity
or
susceptibility
of
young
rats
or
rabbits
following
pre
or
postnatal
exposure
to
fenarimol.
The
data
base
for
reproductive
toxicity
is
considered
complete.
The
multi
generation
reproduction
studies
indicate
that
fenarimol
causes
reduced
fertility
and
dystocia.
Separate
cross
dosing
studies
(
dosing
males
and
mating
with
untreated
females
and
dosing
females
and
mating
with
untreated
males)
indicated
that
the
reduced
fertility
is
due
to
an
effect
in
males
and
the
dystocia
is
an
effect
in
females.
These
effects
of
fenarimol
were
attributed
to
inhibition
of
aromatase
or
the
enzyme
that
converts
androgens
to
estrogens.
In
addition
to
the
guideline
multi
generation
reproduction
study
in
rats,
there
are
nonguideline
studies
that
assess
for
the
reproductive
performance
in
mice
(
MRID
No.:
45502307),
guinea
pigs
(
MRID
No.:
00126525,
00133474
and
00137159)
and
rabbits
(
MRID
No.:
00084967).
The
mouse
study
indicated
that
mice
are
similar
to
rats
in
that
there
is
a
decrease
in
the
reproductive
performance
in
the
males.
However,
neither
the
guinea
pig
or
rabbit
studies
demonstrated
a
decrease
in
reproductive
performance
indicating
that
the
effect
of
fenarimol
on
male
reproductive
performance
is
not
seen
in
all
species
tested.
There
is
no
Guideline
870.7600
dermal
absorption
study
available
with
rats.
The
upper
bound
limit
for
dermal
absorption
was
estimated
by
HIARC
(
J.
Doherty,
9/
6/
01)
to
be
20%
based
on
an
assessment
of
the
rabbit
and
monkey
dermal
absorption
studies
along
with
a
comparison
of
the
rabbit
developmental
toxicity
and
rabbit
21
day
dermal
toxicity
studies.
Subsequently,
Gowan
Company
responded
by
submitting
additional
information
regarding
the
dermal
absorption
study
in
monkeys,
as
well
as
other
background
information.
This
information
was
evaluated
during
a
special
HIARC
12
revisit,
on
5/
23/
02.
The
HIARC
decided
that
a
5%
dermal
absorption
factor
is
appropriate
to
use
for
risk
assessment
purposes.
The
5%
dermal
absorption
factor
was
derived
primarily
from
the
monkey
dermal
absorption
study
(
MRID
No.:
00162538,
1985)
using
the
Feldman
Maibach
model.
Dermal
absorption
rates
of
1.36%,
2.32%,
3.12%
and
4.12%
(
mean
2.73%
±
1.17%)
were
observed
for
the
four
individual
monkeys
in
the
study.
However,
from
8
to
29%
of
the
dermally
applied
radioactivity
was
not
accounted
for.
Since
there
was
variation
in
the
dermal
absorption
in
the
four
monkeys
and
there
was
unaccounted
for
radioactivity,
a
dermal
absorption
value
of
5%
from
this
study
was
considered
appropriate
for
risk
assessment.
In
addition,
the
result
of
a
dermal
absorption
study
with
rabbits
(
MRID
No.:
00046639,
1980),
using
three
formulations,
indicated
up
to
approximately
15%
dermal
absorption.
By
comparison
the
rabbit
developmental
toxicity
study
(
MRID
No.:
47716001)
and
the
rabbit
21
day
dermal
toxicity
study
(
MRID
No.:
00153312)
also
indicated
approximately
15%
dermal
absorption.
However,
the
rabbit
is
recognized
as
being
a
poor
model
for
estimating
dermal
absorption
in
humans,
since
rabbit
skin
is
more
permeable;
therefore,
the
5%
value
based
primarily
on
the
monkey
study
is
considered
appropriate.
Refer
to
the
HIARC
Revisit
report
(
J.
Doherty,
6/
02)
for
a
more
detailed
discussion
of
dermal
absorption.
The
database
for
metabolism
is
considered
to
be
complete.
The
biliary
route
is
the
predominant
route
of
elimination
in
the
rat
but
the
urinary
route
is
the
most
prominent
route
of
elimination
in
the
rabbit.
In
rats,
fenarimol
is
rapidly
absorbed
from
the
gastro
intestinal
tract
and
the
half
life
of
the
plasma
level
was
determined
to
be
11.8
to
16.8
hours.
Most
of
the
radiolabeled
material
was
recovered
in
the
urine
(
5
to
15%)
or
feces
(~
80%
of
the
recovered
isotope)
by
day
7.
Biliary
excretion
was
the
major
route
of
elimination.
Fenarimol
is
extensively
metabolized
in
the
rat;
less
than
one
percent
of
the
parent
is
recovered,
while
more
than
30
metabolites
are
recovered.
Metabolism
of
fenarimol
occurs
by
the
oxidation
of
the
carbinol
phenyl
ring
and
pyrimidine
ring
and
some
qualitative
and
quantitative
differences
in
sexes
and
dose
level
were
noted.
There
are
no
acute,
subchronic
or
developmental
neurotoxicity
studies
available.
The
HIARC
(
July
10,
2001)
determined
that
a
special
developmental
study
with
special
inclusions
to
assess
for
hormonal
effects
in
adults
and
post
weaning
pups,
and
in
vivo
inhibition
of
aromatase
should
be
required.
Acute
and
subchronic
neurotoxicity
studies
are
not
required.
The
toxicology
profile
of
fenarimol
is
shown
in
Table
2
of
this
document.
Table
2.
Toxicology
Profile
for
Fenarimol.
13
Guideline
No./
Study
Type
MRID
No.
(
year)/
Classification
/
Doses
Results
870.3100
(
12
and
18
month
oral
toxicity
rodents
fulfill
this
guideline)
00235175,
45502302
and
45502304
(
1978)/
Acceptable/
Non
Guideline
0,
2.5,
6.5
or
17.5
both
sexes.
NOAEL
=
6.5
mg/
kg/
day
LOAEL
=
17.5
mg/
kg/
day
based
on
increased
relative
liver
weight
and
increased
severity
of
fatty
liver.
870.3150
90
Day
oral
toxicity
in
nonrodents
00056090
(
1975)/
Acceptable/
Guideline
0,
1.25,
5
or
20
mg/
kg/
day.
NOAEL
and
LOAEL
>
20
mg/
kg/
day
(
HDT).
A
one
year
study
(
MRID
00146959
satisfies
this
guideline).
870.3200
21/
28
Day
dermal
toxicity
(
rat)
00153312
(
1985)
Acceptable/
Guideline
0,
500
or
1000
mg/
kg/
day
for
RUBIGAN
(
emulsifiable)
formulation
and
1000
mg/
kg/
day
for
technical
fenarimol.
NOAEL
<
1000
mg/
kg/
day
LOAEL
=
1000
mg/
kg/
day
based
on
slight
liver
weight
effects.
Although
this
study
is
acceptable,
it
is
of
limited
usefulness
for
risk
assessment
because
it
did
no
assess
for
reproductive
effects
or
possible
effects
on
aromatase.
870.3250
90
Day
dermal
toxicity
No
study.
No
study.
870.3465
90
Day
inhalation
toxicity
No
study.
No
study
870.3700a
Prenatal
developmental
in
rodents
00042543/(
1979)
Unacceptable/
Guideline
but
acceptable
with
other
studies
(
see
below).
0,
5,
13,
35
mg/
kg/
day
Maternal
NOAEL
>
35
mg/
kg/
day
(
HDT)
LOAEL
not
established
Developmental
NOEL
=
13
mg/
kg/
day
LOAEL
=
35
mg/
kg/
day
based
on
hydronephrosis
(
this
effect
was
shown
to
be
reversible
and
is
not
considered
adverse).
Special
study
to
assess
for
reversibility
of
hydronephrosis.
00132988/(
1983)
Acceptable/
Non
Guideline.
0
and
35
mg/
kg/
day.
Maternal
NOAEL
=
not
established.
LOAEL
=
35
mg/
kg/
day
based
on
sporadic
dystocia.
Developmental
NOEL
<
35
mg/
kg/
day.
LOAEL
=
35
mg/
kg/
day
based
on
kidney
effects
(
hydronephrosis,
this
effect
was
shown
to
be
reversible
and
is
not
considered
adverse)
Above
two
studies
combine
to
satisfy
the
guideline
requirement
for
a
developmental
toxicity
study
in
rats.
870.3700b
Prenatal
developmental
in
rabbits
44716001/
1990/
Acceptable/
Guideline
0,
15,
50
or
150
mg/
kg/
day.
Maternal
NOAEL
=
50
mg/
kg/
day
LOAEL
=
150
mg/
kg/
day
based
on
increased
abortions
and
decreased
body
weights
and
gain
and
food
consumption.
Developmental
NOAEL
=
>
150
mg/
kg/
day
Guideline
No./
Study
Type
MRID
No.
(
year)/
Classification
/
Doses
Results
14
870.3800
Reproduction
and
fertility
effects
00235175,
45502301
(
1977)
Unacceptable/
Not
upgradeable
0,
2.9,
7.9
or
20
mg/
kg/
day
in
males;
0,
3.4,
9
or
23.5
mg/
kg/
day
in
females.
Parental/
Systemic
NOAEL
>
23.5
mg/
kg/
day
(
HDT)
LOAEL
not
established
Reproductive
LOAEL
<
2.9
mg/
kg/
day
based
on
decreased
fertility
in
the
F1
generation
second
mating.
Offspring
NOAEL
and
LOAEL
could
not
be
established
due
to
anti
fertility
effects
in
the
parental
generations,
which
prevented
valid
assessment
of
the
pup
generations.
Second
study
00235175,
45502302
(
1978)
Acceptable/
Guideline
0,
0.6,
1.2,
2.5
mg/
kg/
day
in
males
and
0,
0.8,
1.7
or
3.2
mg/
kg/
day
in
females.
Parental/
Systemic
NOAEL
>
2.5
mg/
kg/
day
in
males
and
3.2
mg/
kg/
day
in
females
(
HDT)
LOAEL
not
established
Parental
Reproductive
NOAEL
=
0.6
mg/
kg/
day.
LOAEL
=
1.2
mg/
kg/
day
based
on
decreased
liveborn
litter
size
in
the
F1
and
F2
generations.
Offspring.
NOAEL
=
1.2
mg/
kg/
day.
LOAEL
=
2.5
mg/
kg/
day
based
on
decreased
survival
indices
and
possible
presence
of
hydronephrosis
Above
two
studies
combine
to
satisfy
the
guideline
requirement
for
a
multi
generation
reproduction
study
in
rats.
870.3800
Reproduction
and
fertility
effects
(
Special
Study)
00084968
Acceptable/
Non
Guideline
0,
35
mg/
kg/
day
LOAEL
for
males
and
females
>
35
mg/
kg/
d
(
males
decreased
mating
and
epididymal
weight,
females
dystocia
and
related
parameters)
NOAEL
not
established
870.4100a
Chronic
toxicity
rodents
See
combined
chronic
feeding
and
carcinogenicity
study.
870.4100b
Chronic
toxicity
dogs
00146959/
1985/
Acceptable/
Guideline
0,
1.25,
12.5
or
125
mg/
kg/
day.
NOAEL
=
12.5
mg/
kg/
day
LOAEL
=
125
mg/
kg/
day
based
on
reversible
increase
in
liver
weight
and
increase
in
alkaline
phosphatase.
870.4200
Combined
Chronic
Feeding
and
Carcinogenicity
rats
00235175/
1978/
Acceptable/
Guideline
0,2,
5.3,
or
14.6
mg/
kg/
day
for
male
and
0,
2.8,
7.6
or
21.55
mg/
kg/
day
for
females.
NOAEL
=
5.3
mg/
kg/
day.
LOAEL
=
14.6
mg/
kg/
day
based
on
hormonal
changes
(
prolactin
and
luteinizing
hormone)
and
possibly
fatty
liver
change
and
decreased
WBC
count
in
females.
870.4200
Combined
Chronic
Feeding
and
Carcinogenicity
rats
00153313/
1985/
Acceptable/
Guideline
0.5,
1,
2
mg/
kg/
day
for
males
and
0,
0.6,
1.2
or
2.3
mg/
kg/
day
for
females.
NOAEL
=
1
mg/
kg/
day
in
males
and
>
2.3
mg/
kg/
day
in
females.
LOAEL
=
2
mg/
kg/
day
in
males
based
on
minimal
gross
and
microscopic
changes
in
liver
and
possibly
testis.
There
was
no
evidence
of
carcinogenicity
or
increase
in
liver
tumors.
Guideline
No./
Study
Type
MRID
No.
(
year)/
Classification
/
Doses
Results
15
The
above
two
studies
combine
to
satisfy
the
guideline
requirement
for
carcinogenicity
testing
in
rats.
It
should
be
noted
that
the
potential
for
fenarimol
to
cause
decreased
fertility
and
dystocia
at
the
dose
levels
tested
in
the
rat
studies
contributed
to
the
weight
of
evidence
that
the
rat
was
assessed
at
adequate
dose
levels.
870.4300
Carcinogenicity
mice
0071920/
1978/
Acceptable/
Guideline
0,
7,
24
and
86
mg/
kg/
day
for
both
sexes.
NOAEL
=
>
86
mg/
kg/
day
(
HDT).
The
HIARC
and
CARC
concluded
that
there
was
no
evidence
of
carcinogenicity
although
liver
tumors
were
highest
in
the
high
dose
group
but
incidence
was
considered
too
low
to
be
meaningful.
Mutagenticity
870.
See
Table2.
a.
below.
870.6200a
Acute
neurotoxicity
screening
battery
No
study.
No
study.
Not
required.
870.6200b
Subchronic
neurotoxicity
screening
battery
No
study.
No
study.
Not
required.
870.6300
Developmental
neurotoxicity
Study
is
being
required
and
special
inclusions
to
assess
for
possible
effects
due
to
hormonal
disruption
required.
870.7485
Metabolism
and
pharmacokinetics
00261349
and
00261350
(
1985)
A
series
of
studies
with
radioactive
label
in
different
positions
established
that
fenarimol
is
readily
absorbed
and
excreted
with
the
biliary
route
being
most
important
in
rats
but
the
urinary
route
being
important
in
rabbits.
Metabolism
was
extensive
with
30
or
more
metabolites
noted.
Little
radioactivity
remained
in
the
tissue.
Guideline
No./
Study
Type
MRID
No.
(
year)/
Classification
/
Doses
Results
16
870.7600
Dermal
absorption
monkeys
00162538
(
1985)
A
5%
dermal
absorption
factor
is
appropriate
to
use
for
risk
assessment
purposes.
It
was
derived
primarily
from
the
monkey
study
(
00162538)
using
the
Feldman
Maibach
model.
Dermal
absorption
rates
of
1.36%,
2.32%,
3.12%
and
4.12%
(
mean
2.73%
±
1.17%)
were
observed
for
the
four
individual
monkeys.
However,
from
8
to
29%
of
the
dermally
applied
radioactivity
was
not
accounted
for.
Since
there
was
variation
in
the
dermal
absorption
in
the
four
monkeys
and
there
was
unaccounted
for
radioactivity,
a
value
of
5%
was
considered
appropriate.
In
addition,
the
result
of
a
dermal
absorption
study
with
rabbits
(
00046639),
using
three
formulations,
indicated
up
to
approximately
15%
dermal
absorption.
By
comparison
the
rabbit
developmental
toxicity
study
(
47716001)
and
the
rabbit
21
day
dermal
toxicity
study
(
00153312)
also
indicated
approximately
15%
dermal
absorption.
However,
the
rabbit
is
recognized
as
being
a
poor
model
for
estimating
dermal
absorption
in
humans,
since
rabbit
skin
is
more
permeable;
therefore,
the
5%
value
based
primarily
on
the
monkey
study
is
considered
appropriate.
Special
studies
Several
special
studies
were
presented
to
investigate
the
mechanism
of
the
decreased
fertility
and
dystocia.
These
are
listed
above
in
this
table
under
the
heading
for
the
study
type
which
they
most
closely
resemble
(
i.
e.
reproduction
or
developmental)
Table
2.
a.
Mutagenticity/
Genotoxicity
Studies
Study
Results
Bacterial
mutagenicity
(
Ames
test)
Salmonella
typhimurium
and
Escherichia
coli.
Elanco,
1976.
MRID
No.:
243372
(
Acc.
No.:).
Not
mutagenic
with
and
without
metabolic
activation
at
doses
up
to
100
g/
plate.
Classification:
"
Minimum"
(
Acceptable)
Forward
mutation
assay
in
TK
±
mouse
lymphoma
assay.
Elanco,
August
1,
1979.
MRID
No.:
00042538
No
evidence
of
mutagenicity
when
tested
at
0,
3,
6,
12,
50
or
100
g/
mL.
The
100
g/
mL
dose
level
was
toxic.
Classification:
"
minimum"
(
acceptable).
DNA
repair
synthesis.
Elanco,
Study
No.:
790503
1,
June
1979.
MRID
No.:
00042541
No
evidence
of
induction
of
DNA
repair
at
dose
levels
of
0,
0.05,
0.1,
0.5,
10,
50
or
100
nanomoles/
mL
for
five
hours
incubation.
Cytotoxicity
resulted
at
50
and
100
nano
moles/
mL.
Classification:
"
minimum"
(
acceptable).
In
vivo
cytogenetics
in
hamsters.
Cabinet
d'Etudes
et
de
Recherches
en
Tox.
Study
No.:
658,
May
10,
1982.
MRID
No.:
00144051
Negative
for
mutagenic
effects
at
does
of
250
mg/
kg
(
times
2
doses)
in
bone
marrow
cells.
Classification:
Acceptable.
Study
Results
17
micronucleus
assay
mouse
Cabinet
d'Etudes
et
de
Recherches
en
Tox.
Study
No.:
650,
May
1,
1982.
MRID
No.:
00144050
Positive
for
clastogenic
effects
in
male
mice
at
1
gm/
kg
at
24
hours.
Assessments
at
48
and
72
hours
were
considered
confounded
since
there
were
no
positive
controls.
Classification:
UNACCEPTABLE
for
48
and
72
hours.
ACCEPTABLE
for
24
hours.
Evaluation
of
carcinogenicity
in
the
mouse
C3H/
10T
½
embryonic
mouse
fibroblast
culture
system.
Elanco,
August
1,
1980.
MRID
No.:
00046637.
No
malignant
transformations
were
observed
in
fenarimol
treated
cultures
between
4
and
256
nanomoles/
mL.
Classification:
"
minimum"
(
acceptable).
Dominant
lethal
rat.
Lilly,
Study
No.:
R
346
January,
1977
MRID
No.:
00042542
A
single
dose
of
350
mg/
kg
fenarimol
(
in
acacia
solution)
did
not
result
in
symptoms
of
toxicity
to
the
males
and
did
not
indicate
a
dominant
lethal
effect
when
the
rats
were
mated
4
days
after
treatment.
Classification:
"
minimum"
(
acceptable).
Armoatase
inhibition
assay
in
stimulated
rat
ovarian
microsomal
system.
Elanco,
January
1,
1982.
MRID
No.:
00093876
Fenarimol
is
a
moderately
weak
inhibitor
of
aromatase
activity
in
the
stimulated
rat
ovarian
microsomal
system
Classification:
Supplementary.
3.2
FQPA
Considerations
The
FQPA
Safety
Factor
committee
addressed
the
potential
enhanced
sensitivity
of
infants
and
children
from
exposure
to
fenarimol
as
required
by
the
FQPA
of
1996.
HIARC
examined
the
prenatal
developmental
toxicity
studies
in
rats
and
rabbits
and
the
two
generation
reproduction
study
in
rats,
and
concluded
that
the
database
does
not
show
evidence
of
increased
susceptibility
to
fetuses
and
young
(
HIARC,
9/
5/
01).
The
HIARC
determined
that
a
special
developmental
toxicity
study
should
be
required
based
on
the
need
to
determine
if
the
potential
hormonal
effects
as
elicited
by
inhibition
of
aromatase
will
result
in
effects
in
the
rat
pups.
The
FQPA
Safety
Factor
Committee
(
B.
Tarplee,
9/
28/
01)
recommended
that
the
10x
Safety
Factor
should
be
retained
at
10x
for
fenarimol
due
to
the
following
data
gaps:
a
special
developmental
toxicity
study
with
fenarimol
is
required
to
determine
if
the
potential
hormonal
effects
elicited
by
inhibition
of
aromatase
will
result
in
effects
in
the
rat
pups;
and
the
environmental
fate
database
is
incomplete
for
the
aquatic
photolytic
degradate
of
fenarimol,
4
chloro
2(
5
pyrimidyl)
2'
chlorobenzophenone.
A
screening
level
drinking
water
assessment
which
includes
this
degradate
of
concern
is
not
possible
at
this
time
because
of
a
lack
of
data.
The
FQPA
committee
determined
that
the
10x
FQPA
safety
factor
should
be
retained
for
all
populations
and
all
fenarimol
risk
assessments.
18
In
comments
received
on
4/
11/
02,
Gowan
Company
requested
that
the
HED
re
evaluate
this
determination
to
retain
the
10x
FQPA
safety
factor,
and
they
rebuted
the
need
for
a
developmental
neurotoxicity
(
DNT)
study.
In
a
special
revisit
on
May
23,
2002,
the
HIARC
reviewed
and
evaluated
the
potential
for
increased
susceptibility
of
infants
and
children
from
exposure
to
fenarimol
as
required
by
the
Food
Quality
Protection
Act
(
FQPA)
of
1996
and
in
accordance
with
changes
in
HED's
policy
in
determining
the
FQPA
Safety
Factor.
The
HIARC
noted
that
fenarimol
was
not
indicated
as
being
neurotoxic,
but
rather
was
demonstrated
to
cause
hormonal
effects
in
rats,
especially
related
to
inhibition
of
aromatase.
Thus,
the
need
for
a
special
developmental
toxicity
study
that
assesses
the
effects
of
fenarimol
on
hormones.
Evidence
that
suggests
requiring
a
special
developmental
toxicity
study
to
assess
hormonal
effects
is
as
follows:
The
NOAEL
and
LOAEL
for
risk
assessments
are
based
on
reduced
fertility
in
males
and
dystocia
in
females
associated
with
fenarimol's
potential
to
affect
hormones
in
adult
rats.
The
potential
for
fenarimol
to
affect
the
hormonal
system
in
developing
rats
needs
to
be
assessed
to
determine
if
the
developing
fetus
and
neonate
may
also
be
affected
as
can
be
judged
by
the
special
developmental
toxicity
study
that
will
have
special
emphasis
on
potential
disruption
of
the
hormonal
system
by
biochemical
methods
and
include
special
provisions
to
assess
for
physiological
manifestations
of
hormonal
disruption.
The
LOAEL
on
which
risk
assessments
are
based
is
related
to
potential
hormonal
effects.
Based
on
the
weight
of
evidence
presented,
the
HIARC
concluded
that
a
special
developmental
toxicity
study
to
assess
for
hormonal
effects
is
required
for
fenarimol.
This
study
should
follow
the
same
dosing
regimen
as
a
developmental
neurotoxicity
study,
but
does
not
need
to
include
all
of
the
functional
observational
battery
(
FOB)
assessments.
The
protocol
for
this
study
should
be
submitted
to
HED
for
review
prior
to
initiating
the
study.
In
accordance
with
the
2002,
OPP
Guidance
Document
on
Determination
of
the
Appropriate
FQPA
Safety
Factor(
s)
in
Tolerance
Assessment,
this
data
requirement
is
considered
to
be
"
for
cause"
and
therefore
the
HIARC
concluded
that
a
Database
Uncertainty
Factor
of
3X
is
required
until
the
data
are
received
and
evaluated.
3.3
Dose
Response
Assessment
and
Hazard
Endpoint
Selection
The
strengths
and
weaknesses
of
the
fenarimol
toxicology
database
were
considered
during
the
process
of
toxicity
endpoint
and
dose
selection.
In
general,
most
of
the
required
guideline
studies
on
fenarimol
were
available
and
provided
reasonable
confidence
when
the
toxicity
endpoints
and
doses
for
risk
assessment
were
selected.
Based
on
the
evaluation
of
the
above
summarized
studies,
the
Hazard
Identification
Assessment
Review
Committee
(
HIARC)
identified
the
toxicity
endpoints
and
the
dose
levels
for
use
in
risk
assessment
(
HIARC
document
of
9/
5/
01).
The
selected
toxicity
endpoints
are
summarized
in
Table
3.
The
METARC
recommended
(
J.
Doherty,
9/
17/
01),
and
the
HIARC
confirmed,
that
the
reduced
male
fertility
and
dystocia
effects
of
fenarimol
should
be
endpoints
for
human
health
risk
assessment.
It
is
noted
that
the
endpoint
from
the
multi
generation
reproduction
study
is
based
on
decreased
litter
size.
This
decrease
in
litter
size
may
be
a
reflection
of
the
maternal
toxicity
or
the
potential
for
19
fenarimol
to
inhibit
aromatase.
In
this
regard,
it
is
a
meaningful
endpoint
for
all
populations,
males
and
females.
Consequently,
HED
identified
a
reference
dose
for
chronic
exposure
(
cRfD)
of
0.006
mg/
kg/
day
from
the
multi
generation
reproduction
study
based
on
a
no
observed
adverse
effect
level
(
NOAEL)
of
0.6
mg/
kg/
day,
and
a
10X
uncertainty
factor
for
interspecies
extrapolation
and
a
10X
uncertainty
factor
for
intraspecies
variation.
The
NOAEL
of
0.6
mg/
kg/
day
is
based
on
decreased
live
born
litter
size
in
the
F
1
and
F
2
generations
at
a
lowest
observed
adverse
effect
level
(
LOAEL)
of
1.2
mg/
kg/
day.
HED
calculated
a
chronic
Population
Adjusted
Dose
(
cPAD)
of
0.0006
mg/
kg/
day.
The
cPAD
is
the
RfD
divided
by
the
FQPA
safety
factor
(
10X).
Chronic
dietary
exposure
estimates
greater
than
100%
of
the
cPAD
would
exceed
HED's
level
of
concern.
For
risks
associated
with
intermediate
term
(
IT)
exposures
(
1
6
months),
the
same
endpoint
(
NOAEL
of
0.6
mg/
kg/
day)
was
used
for
incidental
oral,
dermal,
and
inhalation
risk
assessments.
A
Margin
of
Exposure
or
MOE,
which
is
the
ratio
of
the
NOAEL
to
the
exposure
estimate,
of
greater
than
1000
does
not
exceed
HED's
level
of
concern
for
IT
risk
assessments.
An
MOE
of
greater
than
1000
is
required
because
of
the
10x
interspecies
factor,
the
10x
intraspecies
factor
and
the
10x
FQPA
factor.
For
the
short
term
(
1
30
day)
incidental
oral,
dermal,
and
inhalation
risk
assessments,
a
LOAEL
of
35
mg/
kg/
day
was
selected.
This
endpoint
is
based
on
decreased
fertility
and
dystocia,
an
indicator
of
hormonal
effects,
observed
in
a
special
non
guideline
cross
breeding
reproduction/
developmental
toxicity
study
in
rats.
Because
a
NOAEL
could
not
be
identified,
and
effects
seen
at
the
lowest
dose
tested,
a
LOAEL
was
used,
and
an
additional
3x
uncertainty
factor
was
applied.
Therefore,
a
MOE
greater
than
3000
does
not
exceed
HED's
level
of
concern
for
short
term
risk
assessments.
Dermal
absorption
was
estimated
to
be
5%
based
on
data
from
a
monkey
dermal
absorption
study
(
see
section
3.1
for
details).
An
acute
dietary
toxicity
endpoint
was
not
identified
by
HIARC,
and
consequently,
no
acute
risk
assessment
was
required.
20
Table
3.
Summary
of
Toxicity
Endpoints
and
Doses
for
Risk
Assessment.
EXPOSURE
SCENARIO
DOSE
(
mg/
kg/
day)
ENDPOINT
STUDY
Acute
Dietary
No
appropriate
study
for
a
single
dose
risk
assessment.
Chronic
Dietary
NOAEL
=
0.6
UF
=
100X
FQPA
=
10X
Decreased
liveborn
litter
size
in
rat
reproduction
study.
LOAEL
=
1.2
mg/
kg/
day
Rat
reproduction
MRID
#
00235175
Chronic
RfD
=
0.006
mg/
kg/
day
Chronic
PAD
=
0.0006
mg/
kg/
day
Incidental
Oral,
Short
Term
LOAEL=
35
UF
=
300X
FQPA
=
10X
Decreased
fertility
and
dystocia
an
indication
of
hormonal
effects.
Special
reproduction
study
MRID
#
0084968
Incidental
Oral,
Intermediate
Term
NOAEL=
0.6
UF
=
100X
FQPA
=
10X
Decreased
liveborn
litter
size.
LOAEL
=
1.2
mg/
kg/
day
Rat
reproduction
MRID
#
00235175
Dermal,
Short
Term
Oral
LOAEL=
35
UF
=
300X
FQPA
=
10X
Decreased
fertility
and
dystocia
an
indication
of
hormonal
effects.
Special
reproduction
study
MRID
#
0084968
Dermal,
Intermediate
Term
Oral
NOAEL=
0.6
UF
=
100X
FQPA
=
10X
Decreased
liveborn
litter
size.
LOAEL
=
1.2
mg/
kg/
day
Rat
reproduction
MRID
#
00235175
Dermal,
Long
Term
Oral
NOAEL=
0.6
UF
=
100X
FQPA
=
10X
Decreased
liveborn
litter
size.
LOAEL
=
1.2
mg/
kg/
day
Rat
reproduction
MRID
#
00235175
Inhalation,
Short
Term
Oral
NOAEL
=
35
UF
=
100X
FQPA
=
10X
Decreased
fertility
and
dystocia
an
indication
of
hormonal
effects
Special
reproduction
study
MRID
#
0084968
Inhalation,
Intermediate
Term
Oral
NOAEL=
0.6
UF
=
100X
FQPA
=
10X
Decreased
liveborn
litter
size.
LOAEL
=
1.2
mg/
kg/
day
Rat
reproduction
MRID
#
00235175
Inhalation,
Long
Term
Oral
NOAEL=
0.6
UF
=
100X
FQPA
=
10X
Decreased
liveborn
litter
size.
LOAEL
=
1.2
mg/
kg/
day
Rat
reproduction
MRID
#
00235175
Because
a
toxicity
endpoint
from
an
oral
study
was
selected
for
dermal
and
inhalation
endpoints,
a
dermal
absorption
factor
of
5%
must
be
used
for
oral
to
dermal
route
to
route
exposures
and
a
100%
inhalation
absorption
factor
must
be
used
for
inhalation
exposures.
3.4
Endocrine
Disruption
The
Agency
is
required
under
the
FFDCA,
as
amended
by
FQPA,
to
develop
a
screening
program
to
determine
whether
certain
substances
(
including
all
pesticide
active
and
other
ingredients)
"
may
have
an
effect
in
humans
that
is
similar
to
an
effect
produced
by
a
naturally
occurring
estrogen,
or
other
such
endocrine
effects
as
the
Administrator
may
designate."
Following
the
recommendations
of
its
Endocrine
Disruptor
Screening
and
Testing
Advisory
Committee
(
EDSTAC),
EPA
determined
that
there
was
scientific
bases
for
including,
as
part
of
the
program,
the
androgen
and
thyroid
hormone
systems,
in
addition
to
the
estrogen
hormone
system.
EPA
also
adopted
EDSTAC's
recommendation
21
that
the
Program
include
evaluations
of
potential
effects
in
wildlife.
For
pesticide
chemicals,
EPA
will
use
FIFRA
and,
to
the
extent
that
effects
in
wildlife
may
help
determine
whether
a
substance
may
have
an
effect
in
humans,
FFDCA
authority
to
require
the
wildlife
evaluations.
As
the
science
develops
and
resources
allow,
screening
of
additional
hormone
systems
may
be
added
to
the
Endocrine
Disruptor
Screening
Program
(
EDSP).
Fenarimol
has
demonstrated
effects
on
hormonal
systems.
When
the
appropriate
screening
and/
or
testing
protocols
being
considered
under
the
Agency's
EDSP
have
been
developed,
fenarimol
may
be
subjected
to
additional
screening
and/
or
testing
to
better
characterize
effects
related
to
endocrine
disruption.
4.0
EXPOSURE
ASSESSMENT
4.1
Summary
of
Registered
Uses
Fenarimol
is
currently
registered
for
use
on
fruit
and
nut
crops
such
as
apples,
cherries,
filberts,
grapes,
pears,
and
pecans
as
well
as
on
ornamental
plants,
trees,
grasses,
and
turf.
Fenarimol
is
also
used
on
imported
bananas.
The
registration
of
fenarimol
is
being
supported
by
Gowan
Company.
The
sole
fenarimol
formulation
class
which
is
registered
for
use
on
fruit
and
nut
crops
is
an
emulsifiable
concentrate
sold
under
the
trade
name
RubiganJ,
and
this
formulation
is
typically
applied
using
ground
equipment.
4.2
Dietary
Exposure
and
Risk
Assessment
4.2.1
Residue
Profile
The
established
permanent
and
time
limited
tolerances
for
fenarimol
are
published
in
40
CFR
§
180.421
and
are
expressed
in
two
different
ways.
Tolerances
listed
under
40
CFR
§
180.421(
a)(
1)
and
§
180.421(
b)
are
expressed
in
terms
of
residues
of
fenarimol
per
se.
Tolerances
listed
under
40
CFR
§
180.421(
a)(
2)
are
expressed
in
terms
of
the
combined
residues
of
fenarimol
and
its
metabolites
[
alpha(
2
chlorophenyl)
alpha(
4
chlorophenyl)
1,4
dihydro
5
pyrimidinemethanol(
Metabolite
B)
and
5[
2
chlorophenyl)(
4
chlorophenyl)
methyl]
3,4
dihydro
4
pyrimidinol]
(
Metabolite
C)
measured
as
the
total
of
fenarimol
and
5[
2
chlorophenyl)(
4
chlorophenyl)
methyl]
pyrimidine
(
calculated
as
fenarimol).
The
registration
requirements
for
plant
metabolism
are
fulfilled.
Acceptable
studies
depicting
the
metabolism
of
[
14C]
fenarimol
in
apples,
cherries,
and
grapes
are
available.
The
apple
and
cherry
metabolism
studies
indicate
that
the
parent
fenarimol
is
the
major
residue
component
whereas
the
grape
metabolism
study
identified
the
parent
plus
Metabolites
B
and
C
as
the
principal
residue
components.
The
Metabolism
Assessment
Review
Committee
(
MARC)
has
determined
that
for
enforcement
purposes,
the
tolerance
should
be
expressed
as
parent
only.
However,
the
dietary
assessment
for
grapes
and
bananas
should
include
the
Metabolites
B
and
C,
because
of
their
structural
similarity
to
parent
fenarimol
and
because
there
are
existing
residue
data
for
the
metabolites
on
those
commodities
(
D277692,
9/
17/
01,
D.
DREW).
Combined
residues
of
Metabolites
B
and
C
occur
on
banana
pulp
samples
at
a
range
of
0.24x
to
1.7x
that
of
parent
fenarimol,
and
on
grapes
at
a
range
of
0.59x
to
3.3x
that
of
parent
fenarimol.
Analytical
methods
exist
for
determining
residues
of
Metabolites
B
and
C
(
measured
as
deshydroxyfenarimol)
in
plants.
The
chemical
names
and
structures
of
fenarimol
and
Metabolites
B
and
C
are
depicted
below
in
Figure
1.
22
N
N
OH
Cl
Cl
NH
N
OH
Cl
Cl
N
NH
Cl
Cl
OH
Figure
1.
Chemical
Names
and
Structures
of
Fenarimol
and
Metabolites
B
and
C.
Common
Name
Chemical
Structure
Chemical
Name
Common
Name
Chemical
Structure
Chemical
Name
Common
Name
Chemical
Structure
Chemical
Name
Fenarimol
Metabolite
B
(
Compound
212746)
Metabolite
C
(
Compound
210302)
[
alpha(
2
chlorophenyl)
alpha(
4
chlorophenyl)
5
pyrimidinemethanol]
[
alpha(
2
chlorophenyl)
alpha(
4
chlorophenyl)
1,4
dihydro
5
pyrimidinemethanol]
[
5[
2
chlorophenyl)(
4
chlorophenyl
methyl]
3,4
dihydro
4
pyrimidinol]
The
qualitative
nature
of
the
residue
in
milk
and
ruminant
tissues
is
adequately
understood.
For
the
purpose
of
registration,
the
terminal
residue
of
concern
in
milk
and
ruminant
and
hog
tissues
is
fenarimol
per
se.
Wet
apple
pomace
is
the
only
animal
feed
item
associated
with
the
registered
uses
of
fenarimol.
There
are
no
hog
or
poultry
feed
items.
The
registration
requirements
for
residue
analytical
methods
are
fulfilled.
Adequate
methods
are
available
for
data
collection
and
enforcement
of
tolerances
for
residues
of
fenarimol
per
se
in/
on
plants
and
livestock.
Adequate
methods
are
also
available
for
determination
of
residues
of
fenarimol
and
Metabolites
B
and
C
in
plants
[
Pesticide
Analytical
Manual
(
PAM)
Volume
II,
Methods
I
(
AMAA
CA
R039
AB
755),
II
(
AM
AA
CA
R072
AA
755),
and
III
(
AM
AA
CA
R124
AA
755].
The
requirements
for
data
depicting
magnitude
of
the
residue
in/
on
plants
are
fulfilled
for
the
following
raw
agricultural
commodities
(
RACs):
apples,
cherries,
filberts,
grapes,
pears,
and
imported
bananas.
Overall,
a
sufficient
number
of
field
trials
were
conducted,
and
the
trials
were
conducted
using
representative
fenarimol
formulations
at
the
maximum
registered
application
rates.
In
some
cases,
residue
data
were
translated
from
closely
related
plant
groups
with
identical
use
patterns.
Adequate
processing
data
are
also
available.
Studies
indicate
that
fenarimol
per
se
concentrate
in
wet
apple
pomace
(
3.7x)
but
not
in
apple
juice
(
0.05x).
Grape
processing
studies
indicate
that
the
combined
residues
of
fenarimol
and
its
metabolites
concentrate
in
grape
juice
(
1.6x)
and
raisins
(
1.2x).
The
concentration
factors
for
grape
products
are
of
such
small
magnitude
that
tolerances
will
not
have
to
be
established
for
grape
juice
or
raisins.
4.2.2
Dietary
Exposure
Risk
from
Food
Sources
HED
conducts
dietary
risk
assessments
using
the
Dietary
Exposure
Evaluation
Model
(
DEEMJ
Version
7.075),
which
incorporates
consumption
data
generated
in
USDA's
Continuing
Surveys
of
Food
Intakes
by
Individuals
(
CSFII),
1989
1992.
For
chronic
dietary
risk
assessments,
the
three
day
average
of
consumption
for
each
sub
population
is
combined
with
average
residues
in
commodities
to
23
determine
average
exposures
in
mg/
kg/
day.
The
chronic
dietary
exposure
assessment
for
fenarimol
is
highly
refined
using
anticipated
residues
based
on
1996
1999
Food
and
Drug
Administration
(
FDA)
monitoring
data
for
apples,
bananas,
cherries,
grapes
and
pears.
Field
trial
residue
data
were
used
for
pecans
and
filberts.
Percent
crop
treated
(%
CT)
information
and
processing
factors,
where
available,
were
used
in
the
assessment.
There
were
no
PDP
monitoring
data
available
for
fenarimol.
Residues
of
fenarimol
per
se
were
nondetectable
(
below
the
method
limit
of
detection,
or
LOD)
in
all
1996
1999
FDA
monitoring
samples
of
apples,
bananas,
grapes,
and
pears
(
a
total
of
more
than
3,000
samples).
Out
of
214
cherry
samples,
three
had
detectable
residues.
Residues
of
fenarimol
per
se
were
nondetectable
(<
LOD)
in/
on
all
but
one
pecan
nut
meat
sample
from
seven
trials.
There
were
no
detectable
residues
in
filbert
samples
from
four
field
trials.
FDA
results
for
bananas
and
grapes
were
adjusted
to
account
for
potential
residues
of
Metabolites
B
and
C.
Banana
and
grape
field
trial
data
indicate
that
total
metabolites
of
fenarimol
occur
in
banana
pulp
at
a
maximum
2X
of
fenarimol
per
se,
and
in
grape
at
a
maximum
of
3x.
The
anticipated
secondary
residues
of
fenarimol
in
ruminant
tissues
(
meat,
fat
and
meat
byproducts)
are
derived
from
a
cattle
feeding
study
(
MRID
40098605,
PP#
4F3108,
F.
Boyd,
9/
20/
84).
Wet
apple
pomace
is
the
only
feedstuff
associated
with
registered
uses
of
fenarimol.
Anticipated
residues
were
all
very
low
(
all
less
than
0.003
ppm).
Milk,
eggs,
poultry
tissue
and
hog
tissue
were
not
included
in
the
dietary
assessment
because
the
Agency
has
determined
that
there
is
no
reasonable
expectation
of
finite
residues
of
fenarimol
in
these
animal
commodities,
and
is
recommending
that
established
tolerances
for
milk,
hog
tissues,
poultry
tissues,
and
eggs
be
revoked
as
per
Category
3
of
40
CFR
§
180.6(
a).
There
are
no
poultry
or
hog
feed
items
associated
with
the
registered
uses
of
fenarimol.
This
assessment
concludes
that
for
all
supported
registered
commodities,
the
chronic
risk
estimates
are
below
the
Agency's
level
of
concern
(<
100%
of
the
chronic
population
adjusted
dose,
cPAD)
for
the
general
U.
S.
population
and
all
population
subgroups
(<
1%
of
the
cPAD).
Table
4.
Results
of
Chronic
Dietary
Exposure
Analysis
Population
Subgroup
Exposure
(
mg/
kg/
day)
%
cPAD1
U.
S.
Population
(
total)
0.000000
<
1
All
Infants
(<
1
year)
0.000001
<
1
Children
1
6
years
0.000002
<
1
Children
7
12
years
0.000001
<
1
Females
13
50
0.000000
<
1
Males
13
19
0.000000
<
1
Males
20+
years
0.000000
<
1
Seniors
55+
0.000000
<
1
1
cPAD
=
0.0006
mg/
kg/
day
4.3
Water
Exposure
Pathway
24
This
assessment
is
based
on
environmental
fate
studies
conducted
in
the
1970s
and
early
1980s.
The
quality
of
the
data
provided
by
these
studies
is
significantly
lower
than
currently
required.
By
current
standards
most
of
these
studies
would
not
be
considered
acceptable
and
the
results
would
not
be
considered
of
sufficient
quality
to
allow
a
reasonably
accurate
assessment
of
the
environmental
fate
of
this
compound.
Fenarimol
is
persistent
and
moderately
mobile
in
the
environment.
In
field
studies,
fenarimol
reportedly
dissipated
with
half
lives
of
3
months
to
several
years
from
soil
and
turf
surfaces
and
much
slower
when
incorporated
into
soil.
Based
on
fenarimol's
chemical
properties
it
is
likely
that
this
chemical
will
move
to
surface
water
and
groundwater,
and
it
may
accumulate
in
the
environment.
It
is
believed
to
be
stable
to
hydrolysis,
anaerobic
microbial
degradation
and
photolysis
on
soil.
It
is
degraded
very
slowly,
if
at
all,
by
aerobic
microbial
processes
with
reported
mean
aerobic
soil
metabolism
half
life
of
about
4
years.
It
is
degraded
by
photolysis
in
aqueous
solution.
The
primary
photolysis
product
is
4
chloro
2(
5
pyrimidyl)
2'
clorobenzophenone.
The
MARC
elected
not
to
exclude
this
aquatic
photolysis
degradate
in
the
drinking
water
exposure
assessment
because:
1)
its
potential
to
occur
in
surface
water;
and,
2)
the
lack
of
data
to
determine
whether
or
not
it
is
of
toxicological
concern.
Tier
I
surface
water
and
groundwater
Estimated
Environmental
Concentrations
(
EECs)
for
fenarimol
were
calculated
using
FIRST
(
surface
water)
and
SCI
GROW
(
groundwater)
modeling
of
application
to
turf.
FIRST
is
a
first
tier
screening
model
designed
as
a
coarse
screen
to
estimate
the
pesticide
concentrations
found
in
an
`
Index
Reservoir'
located
in
Shipman,
Illinois
for
use
in
environmental
risk
assessments
for
drinking
water.
As
such,
it
provides
high
end
estimates
of
the
concentrations
of
a
pesticide
in
drinking
water
that
might
be
derived
from
surface
water.
This
first
level
tier
is
designed
as
a
coarse
screen
and
estimates
concentrations
from
only
a
few
basic
chemical
parameters
and
pesticide
label
application
information.
The
FIRST
program
is
designed
to
mimic
a
more
complex
simulation
such
as
using
the
linked
PRZM
and
EXAMS
models,
but
requires
less
time
and
effort
to
complete.
If
a
risk
assessment
performed
using
FIRST
output
does
not
exceed
the
level
of
concern,
then
one
can
be
reasonably
confident
that
the
acute
risk
will
not
be
exceeded.
However,
for
stable
chemicals
with
long
environmental
half
lives
FIRST
may
significantly
underestimate
long
term
EECs.
SCI
GROW
provides
a
groundwater
screening
exposure
value
to
be
used
in
determining
the
potential
risk
to
human
health
from
drinking
water
contaminated
with
the
pesticide.
SCI
GROW
estimates
EEC
values
in
shallow
groundwater
for
only
a
single
season
and
so
is
much
less
useful
in
estimating
EEC
values
for
stable
compounds
that
may
persist
in
the
environment.
The
EEC
value
calculated
using
SCI
GROW
should
therefore
be
used
with
caution
since
it
probably
underestimates
possible
groundwater
concentrations.
EECs
for
surface
and
ground
water
are
summarized
in
Table
5.
The
surface
water
acute
EEC
is
242
ppb.
The
surface
water
chronic
EEC
is
59
ppb.
These
values
represent
the
maximum
surface
water
concentration,
and
the
mean
yearly
concentration,
respectively,
resulting
from
fenarimol
use
on
turf.
The
groundwater
screening
concentration
calculated
using
SCI
GROW
is
14
ppb
and
represents
a
90
day
average
concentration
value.
This
value
should
be
used
for
both
chronic
and
acute
groundwater
estimates.
It
is
not
possible
to
identify
possible
degradates
of
concern
at
this
time.
Table
5.
Modeling
Results
(
Estimated
Environmental
Concentrations
(
EECs))
for
Application
of
Fenarimol
to
Turf.
25
Model
Concentrationa
FIRST
Peak
Day
(
Acute)
Surface
Water
242
ppb
FIRST
Annual
Average
(
Chronic)
Surface
Water
59
ppb
SCIGROW
Ground
Water
Value
14
ppb
a
EECs
are
for
parent
fenarimol
only
and
do
not
include
aqueous
photolytic
degradate.
4.4
Residential
Exposure
Potential
residential
exposures
may
occur
as
a
result
of
applications
of
fenarimol
to
residential
lawns
or
turf
by
residents
and
by
professional
lawn
care
operators
(
LCOs).
Residential
exposures
have
been
estimated
based
on
label
application
frequency,
and
the
persistence
of
fenarimol.
Most
assumptions
for
risk
estimation
were
based
on
the
Residential
SOPs.
Chemical
specific
data
from
a
turf
transferable
residue
(
TTR)
study
were
available
and
were
used
to
estimate
the
dissipation
of
fenarimol.
As
a
result
of
home
lawn
uses,
the
HED
has
concerns
for
potential
exposures
to
both
adults
and
children.
Application
and
subsequent
exposure
in
residential
settings
for
the
use
sites
other
than
turf
(
i.
e.
ornamentals,
roses,
grapes,
apples,
pears,
cherries,
and
pecans)
is
considered
unlikely.
Dow
AgroSciences,
the
previous
registrant,
has
asserted
to
HED
that
product
for
these
use
sites
is
intended
for
and
used
only
in
commercial
operations.
Product
packaging
and
label
language
suggest
that
applications
in
residential
settings
would
not
occur.
Label
language
restrictions
include
equipment
requirements
such
as
personal
protective
equipment
(
PPE)
requirements,
worker
protection
standard
(
WPS)
requirements,
restrictions
for
use
by
PCOs,
and
application
methods
that
would
never
occur
in
residential
settings.
4.4.1
Home
Uses
4.4.1.1
Handler
Exposure
The
following
use
patterns
have
been
assessed
for
non
occupational
(
residential)
handler
exposures:
1)
granular
application
to
turf
with
a
belly
grinder
spreader;
2)
granular
application
to
turf
with
a
push
type
spreader;
and
3)
granular
spot
treatment
application
by
hand.
Short
term
dermal
and
inhalation
exposures
to
adults
are
likely
from
residents
handling
(
i.
e.
mixing,
loading
and
applying)
granular
product
to
lawns.
As
stated
above,
fenarimol
can
be
applied
to
residential
turf
by
residents
or
LCOs,
either
once
at
the
maximum
application
rate
(
2.73
lb
ai/
acre)
or
twice
as
a
split
application
of
half
the
maximum
rate
per
application.
Additionally,
fenarimol
could
be
applied
to
residential
turf
by
LCOs
as
many
as
12
times
per
season
at
significantly
lower
rates;
i.
e.
0.51
lb
ai/
acre
per
application.
However,
the
registrants
have
stated
that
only
one
to
two
applications
per
season
to
turf
are
anticipated,
since
users
rotate
between
different
systemic
and
contact
fungicides.
To
estimate
aggregate
risks,
the
short
term
dermal
risk
estimates
from
handler
exposures
and
dermal
risk
estimates
from
post
application
exposures
(
post
application
inhalation
exposures
are
not
anticipated)
can
be
combined.
Additionally,
short
term
dermal
and
inhalation
risk
estimates
from
handler
exposures
were
combined.
Table
10
details
the
exposure
and
risk
estimates
for
residents
handling
fenarimol.
Note:
If
label
restrictions
prohibiting
sale
to
or
use
by
homeowners
of
the
granular
product,
as
agreed
to
by
the
registrant,
are
implemented,
then
these
homeowner
handler
scenarios
should
not
occur.
Data
26
confidence
levels
are
described
in
Table
13.
For
short
term
(
1
30
days)
non
occupational
risk
assessments,
HED
has
established
a
level
of
concern
for
MOEs
less
than
3000.
Estimated
risks
to
residential
handlers
from
short
term
dermal
exposures
exceed
HED's
level
of
concern
for
the
scenarios
involving
broadcast
application
to
lawns
by
loading/
applying
the
granular
formulation
with
a
belly
grinder
(
MOE
=
280)
and
by
hand
dispersal
for
spot
treatments
(
MOE
=
1600).
The
risk
estimate
from
dermal
exposures
did
not
exceed
the
level
of
concern
for
residents
applying
fenarimol
granular
formulations
via
a
push
type
spreader
(
MOE
=
45,000).
Additionally,
handler
risk
estimates
from
short
term
inhalation
exposures
did
not
exceed
the
level
of
concern
for
residents
applying
fenarimol
granular
formulations
with
a
belly
grinder
(
MOE
=
25,000),
a
push
type
spreader
(
MOE
=
1,700,000),
or
by
hand
dispersal
spot
treatments
(
MOE
=
71,000).
The
combined
short
term
dermal
and
inhalation
risk
estimates
were
as
follows:
i.
e.
for
belly
grinder
(
MOE
=
280),
hand
dispersal
(
MOE
=
1500),
and
push
type
spreader
(
MOE
=
44,000).
These
estimates
are
not
significantly
different
from
the
dermal
estimates,
because
estimated
inhalation
exposures
are
much
less
than
the
estimated
dermal
exposures
for
homeowner
pesticide
handlers.
4.4.1.2
Postapplication
Exposure
Several
post
application
exposure
scenarios
following
application
to
turf
are
anticipated;
these
are
as
follows:
1)
short
and
intermediate
term
dermal
exposure
to
adults
and
children
(
toddlers,
1
6
years
old);
2)
short
term
incidental
episodic
oral
exposure
to
children
from
ingestion
of
fenarimol
granules;
and
3)
short
and
intermediate
term
oral
exposure
to
children
from
incidental
ingestion
of
soil,
turf
grass
mouthing,
and
hand
to
mouth
activity.
Postapplication
dermal
and
inhalation
exposure
and
risk
estimates
are
presented
in
detail
in
Tables
11
and
12.
For
post
application
residential
exposures,
the
scenarios
with
risks
estimates
that
exceed
HED's
level
of
concern
(
short
term
(
ST)
MOEs
<
3000;
intermediate
term
(
IT)
MOEs
<
1000)
are
as
follows:
1)
the
high
contact
ST
dermal
exposure
activities
(
adults
&
toddlers)
of
working
or
playing
on
lawns;
2)
the
ST
&
IT
incidental
oral
exposure
by
toddlers
through
hand
to
mouth
activities,
and
mouthing
treated
turf
while
playing
on
treated
lawns;
and
3)
the
ST
incidental
episodic
oral
exposure
activity
by
toddlers
of
ingesting
fenarimol
granules
while
playing
on
treated
lawns
[
Note:
HED
considers
this
risk
unlikely
given
the
smaller
particle
size
of
fenarimol
granules
and
the
fact
that
watering
in
likely
occurs
immediately
or
soon
after
application,
in
order
for
the
pesticide
to
be
efficacious.].
However,
for
post
application
residential
exposures,
the
scenarios
with
risks
estimates
that
do
not
exceed
HED's
level
of
concern
(
ST
MOEs
3000;
IT
MOEs
1000)
are
as
follows:
1)
the
high
contact
IT
dermal
exposure
activities
of
working
or
playing
on
lawns
by
adults
or
toddlers;
2)
the
low
contact
ST
&
IT
dermal
exposure
activities
of
mowing
lawns
and
golfing
on
treated
turf;
and
3)
the
ST
&
IT
incidental
oral
exposure
activity
by
toddlers
of
ingesting
soil
while
playing
on
treated
lawns.
Combining
risk
estimates
for
exposure
scenarios
that
are
likely
to
occur
together
resulted
in
risk
estimates
of
greater
concern.
For
example,
it
is
possible
that
the
same
individual
could
apply
granular
fenarimol
product
to
a
residential
lawn
and
immediately
afterwards
perform
high
contact
activities
on
that
lawn.
Combining
the
risk
estimates
for
the
residential
handler
using
a
belly
grinder
spreader
and
the
high
contact
post
application
activities
on
a
lawn
resulted
in
a
MOE
that
exceeds
HED's
level
of
concern
(
MOE
=
214).
Combining
the
post
application
turf
short
term
risk
estimates
for
the
incidental
oral
non
dietary
exposures
to
small
children
(
except
episodic
ingestion
of
fenarimol
granules)
resulted
in
a
risk
estimate
(
MOE
=
690)
that
exceeds
HED's
level
of
concern
(
MOE
<
3000).
Also,
combining
the
post
application
turf
intermediate
term
risk
estimates
for
incidental
oral
non
dietary
exposures
to
small
children
(
except
episodic
ingestion
of
fenarimol
granules)
resulted
in
a
27
risk
estimate
(
MOE
=
62)
that
exceeds
HED's
level
of
concern
(
MOE
<
1000).
Additionally,
combining
the
post
application
turf
dermal
and
incidental
oral
risk
estimates
for
small
children
(
except
episodic
ingestion
of
fenarimol
granules)
resulted
in
MOEs
(
short
term
MOE
=
340;
intermediateterm
MOE
=
58)
that
exceed
HED's
levels
of
concern
(
MOEs
<
3000
&
1000,
respectively).
Summary
of
Risk
Estimates
HED
calculates
risk
estimates
and
expresses
them
as
Margins
of
Exposure
(
MOEs).
For
fenarimol,
MOEs
that
are
less
than
3000
exceed
HED's
level
of
concern
for
short
term
(
ST)
exposures,
and
MOEs
less
than
1000
exceed
HED's
level
of
concern
for
intermediate
term
(
IT)
exposures.
Therefore,
the
target
MOEs
for
non
occupational
ST
and
IT
exposures
to
fenarimol
are
3000
and
1000,
respectively.
Exposure
scenarios
and
their
associated
risk
estimates
are
summarized
in
Table
6.
Risk
estimates
exceeding
HED's
level
of
concern
have
been
bolded
in
the
table.
Tables
10
13
in
Appendix
1
present
a
more
detailed
description
of
the
results
summarized
in
Table
6.
Table
6.
Summary
of
Exposure
Scenarios
and
Risk
Estimates
Exposure
Scenario
Route
of
Exposure
Population
ST
MOEa
IT
MOEb
Residential
Handlers
(
Mixers/
Loaders/
Applicators)
Exposures
Applying
Granular
Product
by
Hand
Application
Dermal
Adult
1600
N/
A
Loading/
Applying
Granular
for
Belly
Grinder
Application
Dermal
Adult
280
N/
A
Loading/
Applying
Granular
for
Push
type
Spreader
Application
Dermal
Adult
45,000
N/
A
Applying
Granular
Product
by
Hand
Application
Inhalation
Adult
71,000
N/
A
Loading/
Applying
Granular
for
Belly
Grinder
Application
Inhalation
Adult
25,000
N/
A
Loading/
Applying
Granular
for
Push
type
Spreader
Application
Inhalation
Adult
1.7E+
6
N/
A
Combined
Residential
Handlers
Exposures
Applying
Granular
Product
by
Hand
Application
Dermal
&
Inhalation
Adult
1500
N/
A
Loading/
Applying
Granular
for
Belly
Grinder
Application
Dermal
&
Inhalation
Adult
280
N/
A
Loading/
Applying
Granular
for
Push
type
Spreader
Application
Dermal
&
Inhalation
Adult
44,000
N/
A
Postapplication
Exposures
High
Contact
Activities
e.
g.
Working
Dermal
Adult
950
1400
High
Contact
Activities
e.
g.
Playing
Dermal
Toddler
660
1000
Low
Contact
Activity
Mowing
Dermal
Adult
27,000
21,000
Low
Contact
Activity
Golfing
Dermal
Adult
14,000
10,000
Exposure
Scenario
Route
of
Exposure
Population
ST
MOEa
IT
MOEb
28
Hand
to
Mouth
Activity
Oral
Toddler
860
78
Incidental
Turf
grass
Mouthing
Oral
Toddler
3400
320
Incidental
Ingestion
of
Soil
Oral
Toddler
2.6E+
5
2.4E+
4
Ingestion
of
Fenarimol
Product
Granules
Oral
Toddler
220
N/
A
Combined
Post
application
Exposures
All
Incidental
Oral
Non
Dietary
(
except
granular
ingestion)
Oral
Toddler
690
62
Dermal
&
All
Incidental
Oral
Non
Dietary
(
except
granular
ingestion)
Oral
&
Dermal
Toddler
340
58
Residential
Handler
(
Belly
Grinder
Spreader)
&
High
Contact
Post
Application
Activities
Dermal
Adult
214
N/
A
a
ST
MOE
=
Short
term
Margin
of
Exposure.
MOEs
that
are
<
3000
are
of
concern
for
short
term
exposures
and
are
shown
in
bold.
N/
A
=
Not
Applicable.
b
IT
MOE
=
Intermediate
term
Margin
of
Exposure.
MOEs
that
are
<
1000
are
of
concern
for
intermediate
term
exposures
and
are
shown
in
bold.
N/
A
=
Not
Applicable.
Uncertainties
Chemical
specific
data
from
a
turf
transferable
residue
(
TTR)
study
(
MRID
44690801)
were
available.
However,
these
TTR
data
were
found
to
be
generally
unacceptable
for
use
in
postapplication
exposure
assessment.
These
data
had
limitations,
as
follows:
1)
the
sampling
period
was
not
sufficiently
long
enough
to
adequately
characterize
dissipation;
2)
only
duplicate
samples
were
collected
at
each
sampling
interval,
not
the
Agency
recommended
triplicate
sampling;
and
3)
the
day
0
(
DAT
0)
data
from
the
California
site
were
inconsistent
with
data
from
the
other
two
sites.
Therefore,
based
on
the
weight
of
evidence
these
data
were
discounted.
However,
a
dissipation
rate
(
8%
daily)
derived
from
these
data
was
used
and
translated
to
residential
application
and
the
Residential
SOPs
were
utilized
to
estimate
initial
residues
(
i.
e.
DAT
0
residues)
based
on
application
rate
and
to
estimate
contact
rates
with
turf.
This
is
a
slow
dissipation
rate.
Also,
the
data
show
that
6.1%,
0.85%,
and
0.59%
(
for
CA,
IN
&
MS,
respectively)
of
the
applied
fenarimol
was
detected
on
DAT
0.
By
comparison,
the
Agency's
SOP
uses
a
transfer
efficiency
(
percent
of
application
rate)
of
5%.
Therefore,
due
to
the
variability
of
the
study
transfer
efficiency
data,
the
poor
quality
of
the
study
itself,
and
because
no
transfer
coefficient
exists
for
the
California
roller
method
that
was
used
in
this
study,
the
HED
will
use
the
5%
transfer
efficiency
rate
for
risk
assessment
purposes.
However,
the
HED
notes
that
the
6.1%
transfer
efficiency
rate
measured
from
the
CA
site
may
be
an
outlier,
since
the
DAT
1
data
(
residues
detected
one
day
after
application)
from
the
CA
site
were
an
order
of
magnitude
lower,
and
the
DAT
0
and
DAT
1
data
from
the
IN
and
MS
sites
were
considerably
lower.
Therefore,
use
of
the
5%
transfer
efficiency
rate
may
be
a
conservative
assumption.
Better
data
may
indicate
a
value
closer
to
1%,
which
would
increase
the
MOEs
by
five
fold.
Dislodgeable
foliar
residue
(
DFR)
data
were
available
for
apple
trees.
These
apple
DFR
data
support
the
EFED
conclusions
concerning
the
persistence
of
fenarimol
in
the
environment.
In
the
DFR
study,
detectable
residues
were
still
present
on
leaf
surfaces
65
days
after
treatment.
The
exposure
estimates
generated
for
the
residential
turf
uses
using
the
Draft
SOPs
are
based
on
29
some
upper
percentile
assumptions
(
i.
e.,
duration
of
exposure
and
maximum
application
rate
for
short
term
assessments,
and
duration
of
exposure
for
intermediate
term
assessments)
and
are
considered
to
be
representative
of
high
end
exposures.
The
uncertainties
associated
with
this
assessment
stem
from
the
use
of
an
assumed
amount
of
pesticide
retained
on
turf,
and
assumptions
regarding
the
transfer
of
fenarimol
residues.
The
turf
risk
estimates
are
believed
to
be
reasonable
and
protective
estimates,
that
are
based
on
Agency
residential
SOPs
that
incorporated
dissipation
data
from
a
fenarimol
turf
transferrable
residue
study
which
met
most
of
the
OPPTS
guidelines.
Therefore,
the
level
of
confidence
is
fairly
high.
By
using
surrogate
study
data
from
PHED,
it
is
assumed
that
pesticides
of
similar
formulation
result
in
similar
exposures
when
handled
in
the
same
manner.
Several
handler
assessments
were
completed
using
"
low
quality"
PHED
data
due
to
the
lack
of
a
more
acceptable
data.
HED
assumes
that
the
general
public's
exposure
may
not
be
mitigated
by
use
of
personal
protective
gear.
Therefore,
only
administrative
controls
(
e.
g.,
formulation
changes
or
use
rate
reductions)
are
feasible
methods
of
risk
reduction.
Mitigating
circumstances
for
residential
exposure
to
fenarimol
residues
may
include
the
watering
in
of
the
granular
formulation
to
turf.
This
instruction,
however,
does
not
prevent
contact
with
treated
turf
prior
to
watering
in.
The
current
granular
label
(
EPA
Reg.
No.
228
298)
recommends,
but
does
not
require
watering
in.
The
soluble
concentrate
label
(
EPA
Reg.
No.
62719
142)
does
not
mention
watering
in.
Therefore,
label
language
should
be
strengthened
to
ensure
that
watering
in
occurs
immediately
after
application.
Additionally,
the
current
labeling
does
not
clearly
specify
whether
the
granular
product
(
EPA
Reg.
No.
228
298)
is
for
professional
use
only.
Specific
labeling
would
help
eliminate
unintentional
use
by
residents.
Labeling
should
also
specifically
advise
against
the
hand
dispersal
and
belly
grinder
type
application
methods.
Note:
If
label
restrictions
prohibiting
sale
to
or
use
by
homeowners
of
the
granular
product,
as
agreed
to
by
the
registrant,
are
implemented,
then
these
homeowner
handler
scenarios
should
not
occur.
4.4.2
Spray
Drift
Spray
drift
is
always
a
potential
source
of
exposure
to
the
public
near
spraying
operations.
This
is
particularly
the
case
with
aerial
application,
but,
to
a
lesser
extent,
could
also
be
a
potential
source
of
exposure
from
groundboom
application
methods.
The
Agency
has
been
working
with
the
Spray
Drift
Task
Force,
EPA
Regional
Offices
and
State
Lead
Agencies
for
pesticide
regulation
and
other
parties
to
develop
the
best
spray
drift
management
practices.
The
Agency
is
now
requiring
interim
mitigation
measures
for
aerial
applications
that
must
be
placed
on
product
labels/
labeling.
The
Agency
has
completed
its
evaluation
of
the
new
data
base
submitted
by
the
Spray
Drift
Task
Force,
a
membership
of
U.
S.
pesticide
registrants,
and
is
developing
a
policy
on
how
to
appropriately
apply
the
data
and
the
AgDRIFT
computer
model
to
its
risk
assessments
for
pesticides
applied
by
air,
orchard
airblast
and
ground
hydraulic
methods.
After
the
policy
is
in
place,
the
Agency
may
impose
further
refinements
in
spray
drift
management
practices
to
reduce
off
target
drift
and
risks
associated
with
aerial
as
well
as
other
application
types
where
appropriate.
5.0
AGGREGATE
RISK
ASSESSMENT
AND
RISK
CHARACTERIZATION
5.1
Acute
Aggregate
Risk
Assessment
Because
an
acute
toxicity
endpoint
was
not
identified
by
HIARC,
an
acute
aggregate
risk
assessment
is
not
required.
30
5.2
Short
and
Intermediate
Term
Aggregate
Risk
Assessment
Because
short
and
intermediate
term
risk
estimates
from
the
turf
use
of
fenarimol
exceed
HED's
level
of
concern,
a
short
and
intermediate
term
aggregate
risk
assessment
cannot
be
performed.
Additional
exposure
to
fenarimol
residues
in
food
or
drinking
water
would
only
cause
short
and
intermediateterm
risk
estimates
to
further
exceed
HED's
level
of
concern.
5.3
Chronic
Aggregate
Risk
Assessment
5.3.1
Aggregate
Chronic
Risk
Assessment
The
aggregate
chronic
risk
assessment
for
fenarimol
considers
both
chronic
food
and
drinking
water
exposure
to
fenarimol.
Chronic
exposure
to
residues
of
fenarimol
in/
on
food
does
not
exceed
HED's
level
of
concern.
However,
the
EECs
for
both
surface
and
ground
water
exceed
the
chronic
DWLOCs
for
some
or
all
population
subgroups
(
see
below),
indicating
a
potential
concern
for
exposure
through
drinking
water.
Tier
I
EECs
were
calculated
for
the
turf
use
of
fenarimol.
A
Tier
II
model
is
not
available
for
turf.
5.3.2
Chronic
DWLOC
Calculations
HED
has
calculated
drinking
water
levels
of
comparison
(
DWLOCs)
for
chronic
exposure
to
fenarimol
in
surface
and
groundwater
which
are
presented
in
Table
7.
The
DWLOC
chronic
is
the
concentration
in
drinking
water
as
a
part
of
the
aggregate
chronic
exposure
that
occupies
no
more
than
100%
of
the
chronic
PAD.
To
calculate
the
DWLOC
for
chronic
exposure
relative
to
a
chronic
toxicity
endpoint,
the
chronic
dietary
food
exposure
(
from
DEEMJ)
was
subtracted
from
the
chronic
PAD
to
obtain
the
acceptable
chronic
exposure
to
fenarimol
in
drinking
water.
DWLOCs
were
then
calculated
using
default
body
weights
and
drinking
water
consumption
figures.
Assumptions
used
in
calculating
the
DWLOCs
include
70
kg
body
weight
for
the
U.
S.
population,
60
kg
body
weight
for
adult
females,
10
kg
body
weight
for
children,
two
liters
of
water
consumption
per
day
for
adults,
and
one
liter
consumption
for
children.
To
estimate
the
potential
risks
associated
with
chronic
exposure
to
fenarimol
in
drinking
water,
HED
compared
estimated
environmental
concentrations
(
EECs)
of
fenarimol
in
surface
and
ground
water
to
chronic
DWLOCs.
If
EECs
are
greater
than
DWLOCs,
then
risk
estimates
exceed
HED's
levels
of
concern.
The
surface
water
EECs
represent
annual
average
concentrations
of
fenarimol,
and
the
ground
water
EECs
represent
90
day
average
concentrations
of
fenarimol.
Table
7.
Fenarimol
Summary
of
Chronic
DWLOC
Calculations
31
Population
Subgroup
cPAD
(
mg/
kg/
day
)
Food
Exposure
(
mg/
kg/
day)
Available
Water
Exposure
(
mg/
kg/
day)
Chronic
DWLOC
(
g/
L)
EFED
Generated
EECs
Surface
Water
(
Chronic)
(
g/
L)
Ground
Water
(
SCI
GROW)
(
g/
L)
U.
S.
Populationa
0.0006
0.000000
0.0006
21
59
14
Females
13
50
yrs
0.000000
0.0006
18
Children
1
6
yrs
b
0.000002
0.000598
6
All
Infants
0.000001
0.000599
6
EEC
=
Estimated
Environmental
Concentrations
for
fenarimol
(
does
not
include
aqueous
photolytic
degradate)
Fenarimol
surface
water
EECs
are
from
FIRST
modeling
.
DWLOC
chronic
=
water
exposure
X
body
weight
(
where
water
exposure
=
cPAD
average
food
exposure)
Liters
of
water/
day
X10
3
Body
weight
=
70
kg
for
U.
S.
Population,
60
kg
for
females,
10
kg
for
infants
and
children
Consumption
=
2L/
day
for
Adults
and
1L/
day
for
infants
and
children
a
Also
represents
Males
13
19
years,
Males
20+
years,
and
Seniors
55+
b
Also
represents
Children
7
12
years
old.
Upon
comparison
of
the
chronic
DWLOCs
with
the
EECs
for
fenarimol,
estimated
using
conservative
modeling
(
Table
7)
there
is
a
potential
concern
for
exposure
from
drinking
water
from
surface
water
sources
for
all
populations,
and
for
infants
and
children
from
ground
water
sources.
That
is,
the
EEC
for
surface
water
is
greater
than
all
DWLOCs,
and
the
EEC
for
ground
water
is
greater
than
the
DWLOCs
for
infants
and
children.
6.0
Cumulative
Exposure
To
Substances
with
Common
Mechanism
of
Toxicity.
The
Food
Quality
Protection
Act
(
1996)
stipulates
that
when
determining
the
safety
of
a
pesticide
chemical,
EPA
shall
base
its
assessment
of
the
risk
posed
by
the
chemical
on,
among
other
things,
available
information
concerning
the
cumulative
effects
to
human
health
that
may
result
from
dietary,
residential,
or
other
non
occupational
exposure
to
other
substances
that
have
a
common
mechanism
of
toxicity.
The
reason
for
consideration
of
other
substances
is
due
to
the
possibility
that
low
level
exposures
to
multiple
chemical
substances
that
cause
a
common
toxic
effect
by
a
common
mechanism
could
lead
to
the
same
adverse
health
effect
as
would
a
higher
level
of
exposure
to
any
of
the
other
substances
individually.
A
person
exposed
to
a
pesticide
at
a
level
that
is
considered
safe
may
in
fact
experience
harm
if
that
person
is
also
exposed
to
other
substances
that
cause
a
common
toxic
effect
by
a
mechanism
common
with
that
of
the
subject
pesticide,
even
if
the
individual
exposure
levels
to
the
other
substances
are
also
considered
safe.
HED
did
not
perform
a
cumulative
risk
assessment
as
part
of
this
risk
assessment
for
fenarimol
because
HED
has
not
yet
initiated
a
review
to
determine
if
there
are
any
other
chemical
substances
that
have
a
mechanism
of
toxicity
common
with
that
of
fenarimol.
For
purposes
of
this
tolerance
reassessment
review,
EPA
has
assumed
that
fenarimol
does
not
have
a
common
mechanism
of
toxicity
with
other
substances.
7.0
TOLERANCE
REASSESSMENT
RECOMMENDATIONS
32
7.1
Tolerance
Reassessment
Recommendation
Table
8
summarizes
the
tolerance
reassessment
for
fenarimol.
Table
8.
Reassessed
fenarimol
tolerances.
Commodity
Established
Tolerance
(
ppm)
Reassessed
Tolerance
(
ppm)
Comment
[
Correct
Commodity
Definition]
Tolerance
Listed
Under
40
CFR
§
180.421(
a)(
1)
Apple
pomace
(
wet
and
dry)
2.0
0.3
The
available
data
indicate
that
the
tolerance
for
wet
apple
pomace
should
be
reduced.
Dry
apple
pomace
is
no
longer
considered
a
significant
livestock
feed
item.
[
Apple,
wet
pomace]
Apples
0.1
0.1
[
Apple]
Cattle,
fat
0.1
0.01
Cattle,
meat
0.01
0.01
Cattle,
mbyp
0.01
0.05
[
Cattle,
meat
byproducts,
except
kidney]
Cattle,
kidney
0.1
0.01
Cattle,
liver
0.1
Revoke
[
included
in
meat
byproducts]
Eggs
0.01
Revoke
There
are
no
poultry
feed
items
associated
with
presently
registered
uses.
Goat,
fat
0.1
0.01
Goat,
meat
0.01
0.01
Goat,
mbyp
0.01
0.05
[
Goat,
meat
byproducts,
except
kidney]
Goat,
kidney
0.1
0.01
Goat,
liver
0.1
Revoke
[
included
in
meat
byproducts]
Hog,
fat
0.1
Revoke
There
are
no
hog
feed
items
associated
with
presently
registered
uses.
Hog,
meat
0.01
Revoke
Hog,
mbyp
0.01
Revoke
Hog,
kidney
0.1
Revoke
Hog,
liver
0.1
Revoke
Horse,
fat
0.1
0.01
Horse,
meat
0.01
0.01
Horse,
mbyp
0.01
0.05
[
Horse,
meat
byproducts,
except
kidney]
Horse,
liver
0.1
Revoke
[
included
in
meat
byproducts]
Horse,
kidney
0.1
0.01
Milk
0.003
Revoke
Category
3
of
40
CFR
§
180.6(
a)
Pears
0.1
0.1
[
Pear]
Pecans
0.1
0.02
[
Pecan]
Commodity
Established
Tolerance
(
ppm)
Reassessed
Tolerance
(
ppm)
Comment
[
Correct
Commodity
Definition]
33
Poultry,
fat
0.01
Revoke
There
are
no
poultry
feed
items
associated
with
presently
registered
uses.
Poultry,
meat
0.01
Revoke
Poultry,
mbyp
0.01
Revoke
Sheep,
fat
0.1
0.01
Sheep,
meat
0.01
0.01
Sheep,
mbyp
0.01
0.05
[
Sheep,
meat
byproducts,
except
kidney]
Sheep,
kidney
0.1
0.01
Sheep,
liver
0.1
Revoke
[
included
in
meat
byproducts]
Tolerance
Listed
Under
40
CFR
§
180.421(
a)(
2)
Bananas
0.5
(
Not
more
than
0.25
ppm
shall
be
present
in
the
pulp
after
peel
is
removed)
0.25
[
Banana]
Cherries
1.0
1.0
[
Cherry]
Grape
juice
0.6
Revoke
Not
required
based
on
reexamination
of
available
grape
processing
data.
Grape
pomace
(
wet
and
dry)
2.0
Revoke
No
longer
considered
a
significant
livestock
feed
item.
Grapes
0.2
0.1
[
Grape]
Raisin
waste
3.0
Revoke
No
longer
considered
a
significant
livestock
feed
item.
Raisins
0.6
Revoke
Not
required
based
on
reexamination
of
available
grape
processing
data.
Tolerance
Listed
Under
40
CFR
§
180.421(
b)
Filberts
0.02
Revoke
(
expired)
Expiration/
revocation
date
of
12/
31/
98
*
Field
trial
data
support
a
0.02
ppm
tolerance
Hops
5
Revoke
(
expired)
Expiration/
revocation
date
of
12/
31/
98
7.2
Codex/
International
Harmonization
The
Codex
Alimentarius
Commission
has
established
several
maximum
residue
limits
(
MRLs)
for
residues
of
fenarimol
in/
on
various
raw
agricultural
and
processed
commodities.
The
Codex
MRLs
are
expressed
in
terms
of
fenarimol
per
se.
A
numerical
comparison
of
the
Codex
MRLs
and
the
corresponding
reassessed
U.
S.
tolerances
is
presented
in
Table
9.
Table
9
shows
that
except
for
cattle
liver,
cherries,
and
pecans,
the
U.
S.
tolerances
and
Codex
MRLs
are
not
in
harmony
with
respect
to
numerical
levels.
34
Table
9.
Codex
MRLs
and
applicable
U.
S.
tolerances
for
fenarimol.
Recommendations
are
based
on
conclusions
following
reassessment
of
U.
S.
tolerances.
Codex
Reassessed
U.
S.
Tolerance,
ppm
Recommendation
And
Comments
Commodity,
As
Defined
MRL
1
(
mg/
kg)
Apple
pomace,
dry
5
wet
apple
pomace
=
0.3
Dry
apple
pomace
is
no
longer
considered
a
significant
livestock
feed
item.
Artichoke
globe
0.1
Banana
0.2
0.25
Cattle
kidney
0.02
(*)
0.01
(*)
Cattle
liver
0.05
Revoke
covered
by
tolerance
for
meat
byproducts
Cattle
meat
0.02
(*)
0.01
(*)
Cherries
1
1
Dried
grapes
(
currants,
raisins
and
sultanas)
0.2
Revoke
Grapes
0.3
0.1
Hops,
dry
5
Melons,
except
watermelon
0.05
Peach
0.5
Pecan
0.02
(*)
0.02
(*)
Peppers,
sweet
0.5
Pome
fruits
0.3
apple/
pear
=
0.1
Strawberry
1
1
All
MRLs
are
at
CXL
step.
An
asterisk
(*)
signifies
that
the
MRL
or
US
tolerance
was
established
at
or
about
the
limit
of
detection.
8.0
DATA
NEEDS
Toxicology:
A
primary
dermal
irritation
study
(
870.2400);
a
28
day
subchronic
inhalation
study
(
870.3465);
and
a
special
developmental
toxicity
study
(
870.6300).
The
special
developmental
toxicity
study
being
required
must
include
a
special
protocol
that
assesses
potential
hormonal
effects.
Product
and
Residue
Chemistry:
Additional
data
are
required
concerning
enforcement
analytical
methods,
stability,
storage
stability,
pH,
UV/
Visible
absorption,
density,
octanol/
water
partition
coefficient,
and
solubility
(
OPPTS
830.1800,
6313,
6317,
7000,
7050,
7300,
7550,
and
7840)
of
the
T/
TGAI.
Storage
stability
data
for
livestock
commodities
are
required
to
support
the
storage
intervals
used
in
the
livestock
feeding
studies.
35
Residential:
Mitigating
circumstances
for
residential
exposure
to
fenarimol
residues
may
include
watering
in
after
application
to
turf.
This
instruction,
however,
does
not
prevent
contact
with
treated
turf
prior
to
watering
in.
The
current
granular
label
(
EPA
Reg.
No.
228
298)
recommends,
but
does
not
require
watering
in.
The
soluble
concentrate
label
(
EPA
Reg.
No.
62719
142)
does
not
mention
watering
in.
Therefore,
label
language
should
be
strengthened
to
ensure
that
watering
in
occurs
immediately
after
application.
Additionally,
the
current
labeling
does
not
clearly
specify
whether
the
granular
product
(
EPA
Reg.
No.
228
298)
is
for
professional
use
only.
Specific
labeling
would
help
eliminate
unintentional
use
by
residents.
Labeling
should
also
specifically
advise
against
the
hand
dispersal
and
belly
grinder
type
application
methods.
Note:
If
label
restrictions
prohibiting
sale
to
or
use
by
homeowners,
as
agreed
to
by
the
registrant
of
the
granular
product,
are
implemented,
then
these
homeowner
handler
scenarios
should
not
occur.
36
Appendix
1.
Detailed
tables
describing
residential
exposure
assessment.
Table
10:
Short
Term
Baseline
Residential
Handler
Exposure
and
Risk
Estimates
Exposure
Scenario
(
Scenario
#)
Crop
Application
Ratea
Amount
Treatedb
Short
Term
Baseline
Dermal
Unit
Exposure
(
mg/
lb
ai)
c
Dermal
Dose
(
mg/
kg/
day)
d
Dermal
MOE
e
Inhalation
Unit
Exposure
(
mg/
lb
ai)
f
Inhalation
Dose
(
mg/
kg/
day)
g
Inhalation
MOEh
Combined
Dermal
&
Inhalation
MOEi
Applicator
Applying
Granular
for
Hand
application
(
1)
Turf
2.73
lb
ai
per
acre
0.023
Acres
per
day
430
0.022
1600
0.470
0.00049
71,000
1500
Mixer/
Loader/
App
Loading/
Applying
Granular
for
Belly
Grinder
application
(
2)
Turf
2.73
lb
ai
per
acre
0.5
Acres
per
day
110
0.13
280
0.062
0.0014
25,000
280
Loading/
Applying
Granular
for
Push
type
spreader
(
ORETF)
application
(
3)
Turf
2.73
lb
ai
per
acre
0.5
Acres
per
day
0.68
0.0008
45,000
0.00091
0.000021
1,700,000
44,000
*
Values
rounded
to
two
significant
figures
a
Maximum
application
rate
based
on
label.
b
Amounts
of
acreage
treated
per
day
are
from
the
Residential
SOP
for
area
treated
in
a
single
day
for
each
exposure
scenario
of
concern.
c
Dermal
Unit
Exposure
(
mg/
lb
ai)
for
hand
and
belly
grinder
application
from
PHED
represents
short
sleeved
shirt
and
shorts,
no
gloves;
open
mixing/
loading
and
application
by
same
person.
Dermal
Unit
Exposure
for
push
type
spreader
from
Outdoor
Residential
Exposure
Task
Force
(
ORETF)
study
OMA003
(
MRID
44972201).
d
Daily
Dermal
Dose
(
mg/
kg/
day)
=
Dermal
Unit
Exposure
(
mg/
lb
ai)
x
lb
ai/
acre
x
Acres
treated
/
day
x
Dermal
Absorption
Factor
(
5/
100)
/
Body
Weight
(
60
kg).
e
Dermal
MOE
=
LOAEL
(
35
mg/
kg/
day)
/
Daily
Dermal
Dose
mg/
kg/
day).
f
Inhalation
Unit
Exposure
from
PHED
for
hand
and
belly
grinder
application.
Inhalation
Unit
Exposure
for
push
type
spreader
from
Outdoor
Residential
Exposure
Task
Force
(
ORETF)
study
OMA003
(
MRID
44972201).
g
Daily
Inhalation
Dose
(
mg/
kg/
day)
=
Inhalation
Unit
Exposure
(
mg/
lb
ai)
x
lb
ai/
acre
x
Acres
treated/
day
/
Body
Weight
(
60
kg).
h
Inhalation
MOE
=
LOAEL
(
35
mg/
kg/
day)
/
Daily
Inhalation
Dose
mg/
kg/
day).
i
Combined
MOE
=
1
/
(
1
/
Dermal
MOE
+
1
/
Inhalation
MOE)
37
Table
11:
Fenarimol:
Residential
Postapplication
Activities
on
Treated
Turf:
Dermal
Exposure
and
Non
Cancer
Risk
Estimates
Short
term
Risk
Estimates
at
DAT
0
Intermediate
term
Risk
Estimates
Activity
TTR
g/
cm2
DAT
0
(
a)
Transfer
Coefficient
(
cm2/
hr)
(
b)
Dermal
Dose
(
mg/
kg/
day)
(
c)
MOE
(
d)
TTR
g/
cm2(
e)
Transfer
Coefficient
(
cm2/
hr)
(
b)
Dermal
Dose
(
mg/
kg/
day)
(
c)
MOE
(
f)
high
contact
lawn
activities:
adults
1.53
14,500
0.037
950
0.0346
7,300
0.00042
1400
high
contact
lawn
activities:
toddler
1.53
5,200
0.053
660
0.0346
2,600
0.0006
1000
mowing
turf:
adults
1.53
500
0.0013
27,000
0.0346
500
0.000029
21,000
golf
course
reentry:
adult
1.53
500
0.0026
14,000
0.0346
500
0.000058
10,000
a
TTR
source:
Standard
Operating
Procedures
(
SOPs)
for
Residential
Exposure
Assessments,
SOP
2.2:
Postapplication
dermal
potential
dose
from
pesticide
residues
on
turf.
DAT
0
residue
values
were
used
for
the
short
term
assessments
at
day
0
after
application.
TTR
=
AR
x
F
x
(
1
D)
t
x
CF1
x
Cf2,
where
AR
=
application
rate
(
lbs
a.
i./
acre),
F
=
fraction
of
a.
i.
retained
on
foliage
(
unitless),
D
=
fraction
of
residue
that
dissipates
daily
(
unitless),
t
=
postapplication
day
on
which
exposure
is
being
assessed,
CF1
=
weight
unit
conversion
factor
to
convert
the
lbs
a.
i.
in
the
application
rate
to
g
for
the
DFR
value
(
4.54E8
g/
lb),
and
CF2
=
area
unit
conversion
factor
to
convert
the
surface
area
units
(
ft2)
in
the
application
rate
to
cm2
for
the
DFR
value
(
24.7E
9
acre/
cm2);
e.
g.
TTR
at
DAT
0
=
2.73
lbs
a.
i./
acre
x
0.05
x
4.54E8
g/
lb
x
24.7E
9
acre/
cm2
=
1.53
g/
cm2.
The
fraction
of
residue
that
dissipates
daily
(
D
=
8%)
was
derived
from
the
turf
transferrable
residue
study
submitted
by
the
registrant,
i.
e.
MRID
44690801.
b
Transfer
coefficient
from
the
Residential
SOP's
(
02/
01).
c
Dermal
Dose
=
TTR
(
g/
cm2)
x
TC
(
cm2/
hr)
x
conversion
factor
(
1
mg/
1,000
g)
x
exposure
time
(
2
hrs/
day
playing
&
mowing;
4
hrs
golfing)
x
Dermal
Absorption
Factor
(
5/
100)/
body
weight
(
60
kg
adult
or
15
kg
child
1
6
yrs).
Short
term
MOEs
were
calculated
using
DAT
0
residue
values
and
intermediate
term
MOEs
were
calculated
using
average
residue
values
(
see
below)
and
TC/
2
(
half
TC
values).
d
MOE
=
LOAEL
(
35
mg/
kg/
day;
based
on
a
oral
study)
/
dermal
dose;
Note:
Target
MOE
is
3000
or
greater,
since
a
NOAEL
was
not
established
and
a
LOAEL
is
used.
e
TTR
source:
MRID
44690801.
Although
this
study
was
unacceptable
for
regulatory
purposes,
average
residue
data
were
used
to
estimate
an
intermediate
term
TTR
value.
An
average
residue
value
from
DAT
1
through
DAT
7
residue
values
from
all
three
sites
for
the
four
days
sampled
was
used;
i.
e.
0.185
g/
cm2/
day.
This
value
was
then
normalized
for
the
lower
application
rate
used
with
multiple
applications,
i.
e.
0.51
lbs
ai/
acre
versus
the
2.73
lbs
ai/
acre
maximum
application
rate
used
for
the
field
studies;
i.
e
0.51/
2.73
x
0.185
=
0.0346
g/
cm2/
day.
f
MOE
=
NOAEL
(
0.6
mg/
kg/
day;
based
on
a
oral
study)
/
dermal
dose;
Note:
Target
MOE
is
1000
or
greater.
Note:
TTR
=
turf
transferable
residue
DAT
=
days
after
treatment
38
Table
12.
Residential
Oral
Nondietary
Short
term
Postapplication
Risks
to
Children
from
"
Hand
to
Mouth"
and
Ingestion
Exposure
When
Reentering
Lawns
Treated
with
Fenarimol
Type
of
Exposure
Short
term
Oral
Dosea
(
mg/
kg/
day)
Short
term
MOEb
Intermediate
term
Oral
Dosea
(
mg/
kg/
day)
Intermediate
term
MOEb
(
1)
Hand
to
Mouth
Activity
(
Finger
licking)
0.040768
860
0.007616
78
(
2)
Incidental
Turfgrass
Mouthing
0.010192
3400
0.002
320
(
3)
Incidental
Ingestion
of
Soil
1.367E
4
260,000
0.0000255
2.4E+
4
(
4)
Ingestion
of
Granules
0.156
224
Combined
Oral
Nondietary
(
except
granular
ingestion)
c
0.0511
690
0.00964
62
Combined
Oral
(
except
granular
ingestion)
and
Dermald
340
58
Footnotes:
a
Application
rate
for
the
short
term
estimates
represents
maximum
label
rate
from
current
EPA
registered
labels:
EPA
Reg.
No.
62719
142
soluble
concentrate/
liquid
formulation
&
EPA
Reg.
No.
228
298
granular
product
formulations,
max
rate
is
2.73
lb
ai/
acre
for
both.
For
intermediate
term
estimates,
the
application
rate
of
0.51
lbs
ai/
acre
was
used.
Incidental
oral
doses
were
calculated
using
formulas
presented
in
the
Residential
SOPs
(
updated
1999
2000).
Short
and
intermediate
term
doses
were
calculated
using
the
following
formulas:
(
1)
Hand
to
mouth
oral
dose
to
children
on
the
day
of
treatment
(
mg/
kg/
day)
=
[
application
rate
(
lb
ai/
acre)
x
fraction
of
residue
dislodgeable
from
potentially
wet
hands
(
5%)
x
11.2
(
conversion
factor
to
convert
lb
ai/
acre
to
g/
cm2)]
x
median
surface
area
for
1
3
fingers
(
20
cm2/
event)
x
hand
to
mouth
rate
(
20
events/
hour)
x
exposure
time
(
2
hr/
day)
x
0.001
mg/
µ
g]
x
50%
extraction
by
saliva
/
bw
(
15
kg
child
1
6
yrs).
This
formula
is
based
on
proposed
changes
to
the
December
1999
Residential
SOPs.
[
Note:
The
intermediate
term
estimates
used
10
events
per
hour.]
(
2)
Turf
mouthing
oral
dose
to
child
on
the
day
of
treatment
(
mg/
kg/
day)
=
[
application
rate
(
lb
ai/
acre)
x
fraction
of
residue
dislodgeable
from
potentially
wet
hands
(
20%)
x
11.2
(
conversion
factor
to
convert
lb
ai/
acre
to
g/
cm2)
x
ingestion
rate
of
grass
(
25
cm2/
day)
x
0.001
mg/
µ
g]
/
bw
(
15
kg
child
1
6
yrs).
(
3)
Soil
ingestion
oral
dose
to
child
on
the
day
of
treatment
(
mg/
kg/
day)
=
[(
application
rate
(
lb
ai/
acre)
x
fraction
of
residue
retained
on
uppermost
1
cm
of
soil
(
100%
or
1.0/
cm)
x
4.54e+
08
g/
lb
conversion
factor
x
2.47e
08
acre/
cm2
conversion
factor
x
0.67
cm3/
g
soil
conversion
factor)
x
100
mg/
day
ingestion
rate
x
1.0e
06
g/
g
conversion
factor]
/
bw
(
15
kg;
child
1
6
yrs).
Short
term
dose
based
residue
on
the
soil
on
day
of
application.
(
4)
Granular
pellet
ingestion
(
mg/
kg/
day)
oral
dose
to
child
=
[
granule
ingestion
rate
(
300
mg/
day)
x
fraction
of
ai
of
granule
formulations
(
0.0078)]
/
bw
(
15
kg
child
1
6
yrs).
b
Short
term
MOE
=
LOAEL
(
35
mg/
kg/
day)
/
Oral
Dose
(
mg/
kg/
day).
LOAEL
from
a
rat
cross
fertility
study;
target
MOE
of
3000,
because
a
NOAEL
was
not
established.
Intermediate
term
MOE
=
NOAEL
(
0.6
mg/
kg/
day)
/
Oral
dose
(
mg/
kg/
day).
NOAEL
from
a
two
generation
rat
reproduction
study;
target
MOE
of
1000.
c
Combined
MOEs
=
LOAEL
/
[
sum
of
incidental
oral
doses],
with
a
target
MOEs
of
3000
&
1000
for
short
&
intermediate
term,
respectively.
d
Combined
Dermal
+
Incidental
Oral
MOEs
=
1/
[
1/
MOEdermal
+
1/
MOEoral
];
see
Table
6
for
dermal
MOE
for
high
contact
short
term
activity
(
MOE
=
660)
and
intermediate
term
activity
(
MOE
=
1000)
on
turf
.
39
Table
13.
Residential
Exposure
Scenario
Descriptions,
Assumptions,
and
Data
Sources
for
the
Use
of
Fenarimol
Exposure
Scenario
(
Number)
Data
Source
Standard
Assumptionsa
Commentsb
Loading/
Applying
with
a
Push
type
Granular
Spreader
(
1)
ORETF
Study
OMA003
MRID
449722
01
0.5
acres
Baseline:
Hand,
dermal,
and
inhalation
(
30
replicates
each)
data
used
to
establish
exposure
values.
Average
laboratory
and
field
recoveries
were
within
guideline
parameters;
data
of
acceptable
quality
(
AB
grade).
Loading/
Applying
Granular
with
a
Belly
grinder
(
2)
SOPs
for
Residential
Exposure
Assessments
(
12/
97)
0.5
acres
turf;
or
0.025
acres
(
1,000
ft2)
for
turf
spot
treatment
Baseline:
Dermal
(
20
45
replicates)
and
hand
(
23
replicates)
exposure
values
are
based
on
ABC
grade
data.
Inhalation
(
40
replicates)
exposure
value
is
based
on
AB
grade
data.
Medium
confidence
in
dermal/
hand
data
and
high
confidence
in
inhalation
data.
Applying
Granular
by
Hand
(
3)
SOPs
for
Residential
Exposure
Assessments
(
12/
97)
0.025
acres
(
1,000
ft2)
for
spot
treatment
Baseline:
Dermal.
hand,
inhalation
(
each
16
replicates)
exposure
values
are
based
on
ABC
grade
data.
Medium
confidence
in
all
data.
"
No
gloved"
hand
exposure
was
back
calculated
applying
a
90
percent
protection
factor
to
"
gloved"
hand
exposure
data;
therefore
a
10x
FQPA
safety
factor
has
been
applied
to
the
hand
exposure.
a
Standard
Assumptions
based
on
HED
estimates.
b
"
Best
Available"
grades
are
defined
by
HED
SOP
for
meeting
Subdivision
U
Guidelines.
Best
available
grades
are
assigned
as
follows:
matrices
with
grades
A
and
B
data
and
a
minimum
of
15
replicates;
if
not
available,
then
grades
A,
B
and
C
data
and
a
minimum
of
15
replicates;
if
not
available,
then
all
data
regardless
of
the
quality
and
number
of
replicates.
Data
confidence
are
assigned
as
follows:
High
=
grades
A
and
B
and
15
or
more
replicates
per
body
part
Medium
=
grades
A,
B,
and
C
and
15
or
more
replicates
per
body
part
Low
=
grades
A,
B,
C,
D
and
E
or
any
combination
of
grades
with
less
than
15
replicates
| epa | 2024-06-07T20:31:43.772774 | regulations | {
"license": "Public Domain",
"url": "https://downloads.regulations.gov/EPA-HQ-OPP-2002-0250-0009/content.txt"
} |
EPA-HQ-OPP-2002-0250-0010 | Supporting & Related Material | "2002-09-24T04:00:00" | null | UNITED
STATES
ENVIRONMENTAL
PROTECTION
AGENCY
WASHINGTON,
D.
C.
20460
OFFICE
OF
PREVENTION,
PESTICIDES
AND
TOXIC
SUBSTANCES
May
8,
2002
MEMORANDUM
SUBJECT:
HED
Response
to
Registrants
30
Day
Error
Only
Comments
Concerning
the
Preliminary
Residential
Risk
and
Exposure
Assessment
for
Fenarimol,
as
Part
of
the
Human
Health
Assessment
for
the
Tolerance
Reassessment
Eligibility
Decision
(
TRED)
Document.
Chemical
No.
206600.
No
MRID
#.
DP
Barcode
No.
D282386.
FROM:
Barry
O'Keefe,
Residential
Exposure
Assessor
Reregistration
Branch
3
Health
Effects
Division
(
7509C)
THRU:
Catherine
Eiden,
Branch
Senior
Scientist
Reregistration
Branch
3
Health
Effects
Division
(
7509C)
TO:
Tom
Myers,
Chemical
Review
Manager
Special
Review
and
Reregistration
Division
(
7508C)
This
review
is
in
response
to
Gowan
Company's
comments
and
questions
concerning
the
residential
risk
and
exposure
assessment
portion
of
the
Health
Effects
Division's
(
HED's)
Tolerance
Reassessment
Eligibility
Decision
(
TRED)
document
for
fenarimol.
Gowan
Company
made
several
comments
and
asked
several
questions
concerning
this
assessment.
Gowan
Company's
comments
and
questions,
and
the
HED's
responses
are
as
follows:
Comment/
Question
#
1:
Gowan
Company
agreed
with
the
Agency
that
the
two
methods
of
applying
the
Riverdale
Chemical
Company's
granular
product
(
EPA
Reg.
No.
228
298)
should
be
prohibited
on
the
label;
i.
e.
the
bellygrinder
for
broadcast
application
or
hand
application
for
spot
treatments.
Gowan
commented
that
the
possibility
of
either
a
homeowner
or
professional
applicator
choosing
either
one
of
these
application
methods
is
remote
given
the
fact
that
up
to
350
lb
of
product
per
acre
can
be
applied.
HED
Response:
The
HED
is
required
to
assess
these
two
application
method
scenarios,
since
the
label
does
not
prohibit
handlers
from
applying
this
granular
product
using
these
application
methods.
The
HED
does
not
consider
the
application
of
350
lb
of
product
per
acre
to
be
a
remote
possibility.
However,
the
preliminary
risk
assessment
was
based
upon
0.5
acres
treated
for
the
bellygrinder
scenario,
and
0.023
(
1000
ft2)
acres
treated
for
the
hand
application
spot
treatment
scenario.
HED
recommends
prohibition
of
these
two
types
of
application
for
granular
products;
i.
e.
broadcast
by
2
belly
grinder,
and
spot
treatment
by
hand.
Comment/
Question
#
2:
Gowan
agreed
with
the
Agency's
recommendation
that
prompt
watering
in
should
be
required
for
the
granular
product
used
on
residential
turf.
HED
Response:
HED
actually
recommended
that
label
language
should
be
strengthened
to
ensure
that
watering
in
occurs
immediately
after
application
for
all
end
use
products
used
on
turf.
This
recommendation
was
not
exclusive
only
to
the
granular
product,
nor
was
it
exclusive
only
to
residential
turf.
HED
recommends
that
all
end
use
products
be
watered
in
immediately
after
application
on
turf,
lawns
and
playing
fields.
However,
watering
in
immediately
after
application
cannot
be
mandated
on
the
labels,
because
there
is
no
way
to
ensure
that
applicators
will
adhere
to
this
direction.
Also,
watering
in
would
probably
be
a
lot
more
difficult
to
do
on
playing
fields,
than
on
home
lawns.
Comment/
Question
#
3:
Gowan
stated
that
the
Agency's
exposure
calculations
compounded
a
number
of
conservative
default
assumptions,
as
follows:
Comment/
Question
#
3a:
Gowan
stated
that
the
Agency
used
a
5%
transfer
coefficient
from
turf
that
is
two
orders
of
magnitude
higher
than
the
transfer
coefficients
observed
with
other
liquid
products
on
turf.
HED
Response:
As
stated
in
the
preliminary
risk
assessment,
HED
used
the
Agency's
SOP
default
transfer
efficiency
rate
(
percent
of
application
rate)
of
5%;
i.
e.
5%
of
application
rate
available
for
transfer
from
treated
turf
to
wet
hands.
HED
will
continue
to
use
this
5%
transfer
efficiency
rate
until
data
indicate
that
a
different
rate
should
be
used.
Data
from
the
registrant
submitted
turf
transfer
residue
(
TTR)
study
showed
that
6.1%,
0.85%
and
0.59%
(
for
CA,
IN
and
MS,
respectively)
of
the
applied
fenarimol
was
detected
on
turf
immediately
after
application.
This
study
itself
was
of
poor
quality,
and
therefore
the
data
were
not
used
to
generate
risk
estimates
because
the
data
were
too
variable,
and
because
no
relevant
transfer
coefficient
exists
for
the
California
roller
method
that
was
used
in
this
study.
There
is
interdependence
of
the
transferable
residue
value
and
the
human
activity
expressed
in
the
transfer
coefficient
(
TC).
The
TC
for
short
term
exposures
is
based
on
a
study
by
Formoli
(
1996)
evaluated
by
the
California
Department
of
Pesticide
Regulation
(
CDPR),
in
which
propetamaphos
was
applied
to
carpets.
The
transferable
residues
in
that
study
were
approximately
1%
of
the
application
rate.
The
TTR
method
used
to
measure
concurrent
transferable
residues
was
the
California
roller
(
also
referred
to
as
the
cloth
roller
and
CDFA
roller).
Other
proprietary
studies
using
this
method
suggest
1.6
3%
transferability.
The
California
EPA,
in
a
letter
to
the
USEPA
during
the
time
the
SOPs
were
taken
to
the
USEPA
Science
Advisory
Panel
(
SAP)
also
affirm
that
the
transferability
of
this
method
is
less
than
5%.
TTR
data
generated
by
members
of
the
Outdoor
Residential
Entry
Task
Force
(
ORETF)
rely
on
a
modified
version
of
the
California
roller
(
ORETF
roller)
that
appears
to
have
a
much
lower
transfer
efficiency
(
percent
of
application
rate)
than
the
original
version.
Many
TTR
data
submitted
by
ORETF
members
show
transfer
efficiencies
of
<
1%
for
sprayable
3
formulations
and
<
0.5%
for
granular
formulations.
The
USEPA
Office
of
Research
and
Development
(
ORD)
has
conducted
a
round
robin
test
of
TTR
methods
that
included
the
ORETF
roller
(
Fortune
1997).
While
ORD
concluded
that
the
ORETF
roller
method
performed
the
best
of
all
methods,
transfer
efficiency
for
three
liquid
herbicide
formulations
indicated
a
transfer
efficiency
of
approximately
0.5%.
The
ORETF
data
should
not
be
used
with
the
revised
transfer
coefficients
of
approximately
1
to
5%.
The
ORETF
is
generating
task
force
specific
transfer
coefficients
to
be
used
with
the
ORETF
member
TTR
data.
ORETF
post
application
exposure
data
has
been
submitted
and
is
being
reviewed.
Comment/
Question
#
3b:
Gowan
believes
that
the
assumed
20%
dermal
absorption
number
used
by
HED
should
be
reduced
by
an
order
of
magnitude.
Gowan
submitted
rationale
and
numerous
literature
to
support
their
rationale.
HED
Response:
HED
toxicologists
will
address
these
comments
and
questions.
Please
refer
to
that
formal
response
for
further
details.
Comment
#
3c:
Gowan
commented
that
they
had
"
observed
in
two
other
studies
that
presumably
persistent
compounds
are
rapidly
removed
from
home
lawns
for
the
simple
reason
that
grass
is
mowed."
HED
Response:
HED
suggests
that
Gowan
Company
submit
copies
of
these
studies
to
the
Agency.
Comment
#
3d:
Gowan
commented
that
the
safety
factors
(
target
MOEs
of
1000
for
intermediate
term
exposure
and
3000
for
short
term
exposure)
are
very
conservative.
HED
Response:
HED
toxicologists
will
address
this
comment.
Please
refer
to
that
formal
response
for
further
details.
4
Internal
Points
for
SRRD
(
i.
e.
not
meant
to
be
part
of
the
formal
response
to
comments)
1.
Watering
In
Is
it
practical
and/
or
enforceable
to
require
registrants
to
add
a
requirement
or
recommendation
to
their
end
use
labels
to
water
in
the
product
immediately
after
it
is
applied
to
turf,
lawns
or
playing
fields?
In
the
real
world,
does
this
truly
mean
anything?
What
percentage
of
applicators
will
actually
adhere
to
this
requirement
or
recommendation?
Fenarimol
is
a
systemic
fungicide.
Therefore,
in
order
to
be
efficacious,
it
must
enter
the
root
zone
so
that
it
can
be
taken
up
by
the
grass.
The
current
labels
advise
users
to
irrigate
if
precipitation
does
not
occur
within
24
hours.
Whether
by
precipitation
and/
or
irrigation
the
watering
in
of
fenarimol
product
will
undoubtedly
remove
fenarimol
residues
from
the
surface
of
grass
blades,
and
therefore
reduce
the
amount
of
fenarimol
residues
transferable
to
individuals
contacting
treated
grass.
The
question
is,
by
how
much
is
the
potentially
transferrable
residue
reduced
by
watering
in?
Based
upon
data
from
other
pesticides
applied
to
turf,
watering
in
may
provide
an
average
reduction
in
residues
of
2
to
5
fold
for
granular
formulations.
Watering
in
liquid
formulations
after
application
to
turf
result
in
greater
reductions
in
dislodgeable
residues,
e.
g.
residues
of
the
herbicide
diazinon
were
reduced
by
80
fold.
For
the
liquid
herbicide
pronamide,
watering
in
resulted
in
a
13
fold
reduction
in
residues.
For
the
nematicide
fenamiphos
(
emulsifiable
concentrate),
watering
in
resulted
in
a
30
fold
reduction
in
residues.
Unfortunately,
OPP/
ORE
scientists
cannot
provide
SRRD
with
a
quantitative
reduction
factor
or
range.
However,
common
sense
dictates
that
a
sizable
reduction
in
residues
and
associated
risk
will
occur
with
watering
in.
Therefore,
SRRD
can
use
this
knowledge
to
discuss
why
mitigation
is
not
being
required
while
MOEs
of
concern
remain
(
i.
e.
MOEs
somewhat
below
our
targets).
2.
Episodic
Ingestion
of
Fenarimol
Granules
by
Toddlers
In
the
preliminary
residential
risk
assessment,
a
short
term
MOE
of
220
was
estimated
for
episodic
ingestion
of
fenarimol
product
granules.
This
is
well
below
the
target
MOE
of
3000.
However,
based
upon
the
particle
sizes
of
these
granules,
HED
characterized
this
potential
risk
to
be
less
likely
or
difficult
to
occur,
and
therefore,
not
of
great
concern.
Is
this
a
valid
characterization?
The
characterization
in
the
preliminary
residential
risk
assessment
is
as
follows:
"
Information
was
received
from
Riverdale
Chemical
Company
regarding
the
size
and
distribution
of
the
granular
formulation
they
manufacture.
This
information
is
helpful
in
refining
or
characterizing
the
estimate
of
potential
risk
from
episodic
incidental
ingestion
of
granules
beyond
the
current
screening
level.
For
example,
the
granules
would
be
considered
more
attractive
and
more
likely
to
be
consumed
if
readily
visible
and
easily
picked
up
by
a
child.
The
Riverdale
Chemical
Company
product
information,
provided
to
HED
by
telephone
conversation
on
July
18,
2001,
indicates
that
93%
of
the
product
has
a
particle
diameter
range
of
0.594
to
0.841
mm,
with
the
remaining
7%
in
the
0.841
to
2
mm
size.
The
granules
are
white
in
color.
If
evenly
distributed,
individual
grains
would
be
difficult
to
pick
up,
or
even
to
see
when
applied
on
a
lawn,
and
if
used
according
to
label
directions
and
soil
5
incorporated
by
watering
in.
Therefore,
given
proper
application
this
product
would
be
difficult
for
a
small
child
to
grasp
and
then
mouth
or
ingest."
Additionally,
if
hand
dispersal
application
is
prohibited,
then
unevenly
distributed
granules
will
be
much
less
likely.
Also,
watering
in,
whether
recommended
or
required
will
reduce
the
chances
of
toddlers
grasping
granules.
| epa | 2024-06-07T20:31:43.789822 | regulations | {
"license": "Public Domain",
"url": "https://downloads.regulations.gov/EPA-HQ-OPP-2002-0250-0010/content.txt"
} |
EPA-HQ-OPP-2002-0250-0011 | Supporting & Related Material | "2002-09-24T04:00:00" | null | 1
OFFICE
OF
PREVENTION,
PESTICIDES,
AND
TOXIC
SUBSTANCES
UNITED
STATES
ENVIRONMENTAL
PROTECTION
AGENCY
WASHINGTON,
D.
C.
20460
MEMORANDUM
Subject:
EPA
Id
No.:
206600.
Fenarimol:
Tentative
response
to
the
registrant's
comments
on
the
preliminary
human
health
risk
assessment
Toxicology
issues.
PC
Code
No.:
206600
DP
Barcode
No.:
D282387
Submission
No.:
S614096
From:
Barry
O'Keefe
and
John
Doherty
ReRegistration
Branch
III
Health
Effects
Division
7509C
To:
Tom
Myers
and
Margaret
Rice
Product
Manager
#
52
Special
Review
and
ReRegistration
Division
7507C
Through:
Catherine
Eiden
Branch
Senior
Scientist
ReRegistration
Branch
III
Health
Effects
Division
7509C
Introduction
The
Gowan
Company
submitted
several
comments
and
questions
concerning
the
data
requirements
and
data
interpretation
presented
in
the
toxicology
assessment
portion
of
the
Health
Effects
Division's
(
HED's)
Tolerance
Reassessment
Eligibility
Decision
(
TRED)
document
for
fenarimol.
HED
is
currently
conducting
a
detailed
review
of
these
comments
and
questions.
No
conclusions
can
be
reached
for
some
of
these
issues
until
all
of
the
supporting
data
and
information
provided
to
the
Agency
is
assessed
and
reviewed
by
appropriate
peer
review
committees
in
HED.
This
process
is
currently
underway.
After
review,
some
of
the
issues
raised
by
the
Gowan
Company
may
result
in
changes
in
risk
estimates.
Toxicology
issues
of
concern
to
the
Gowan
Company
and
tentative
comments
on
their
status
are
listed
below.
Other
issues
such
as
those
related
to
exposure
and
chemistry
have
been
addressed
separately.
1.
Requirement
for
the
Primary
Dermal
Irritation
Study.
2
A
primary
dermal
irritation
study
for
technical
fenarimol
was
indicated
as
a
data
gap.
The
registrant
has
agreed
to
conduct
the
Primary
Dermal
Irritation
Study
to
satisfy
the
requirement
and
expects
to
submit
this
study
before
the
end
of
2002.
2.
Requirement
for
a
28
Day
Inhalation
Toxicity
Study.
The
Gowan
Company
requested
that
the
Agency
rescind
the
data
requirement
for
the
28
day
inhalation
study.
They
disagree
on
its
need
and
cite
that
this
issue
was
addressed
recently
by
the
CropLife
America
an
industrial
organization.
They
also
state
that
the
sprays
that
will
typically
result
from
fenarimol
use
will
have
droplets
that
will
be
tens
or
thousands
of
micrometers
in
diameter
or
much
larger
than
the
respirable
droplets
of
a
few
micrometers
in
diameter.
There
larger
droplets
will
not
reach
the
alveoli
and
will
become
trapped
in
the
upper
respiratory
tract
and
eventually
swallowed.
Thus,
the
endpoint
from
an
oral
toxicity
study
is
a
more
appropriate
endpoint.
There
have
been
some
recent
changes
in
HED
policy
regarding
the
need
for
subchronic
inhalation
toxicity
studies.
The
comments
of
the
CropLife
America
organization
have
been
taken
into
consideration
at
a
recent
presentation
to
the
Agency.
As
a
result
of
these
recent
changes,
the
Gowan
Company
may
submit
a
waiver
for
the
28
day
inhalation
study.
This
waiver
must
contain
sufficient
data
on
the
particle
size
of
the
sprays
and
other
preparations
that
may
result
in
inhalation
exposure.
It
also
must
contain
sufficient
other
information
regarding
the
potential
inhalation
exposure
such
as
duration
of
exposure
in
terms
of
hours
per
day,
per
week
etc.
The
completed
waiver
request
will
be
presented
to
a
peer
review
committee
that
will
determine
the
need
for
the
subchronic
inhalation
toxicity
study.
This
peer
review
group
will
consist
of
toxicologists
with
expertise
in
inhalation
toxicology
as
well
as
occupational
and
residential
exposure
representatives.
The
decision
on
the
need
for
the
subchronic
inhalation
toxicity
study
will
be
based
all
relevant
factors.
The
more
complete
the
information
in
the
waiver
request
is,
the
better
chance
for
the
waiver
to
be
granted.
The
limited
information
provided
in
the
April
10,
2002
letter
in
not
sufficient
to
bring
to
a
peer
review
committee
to
consider
a
waiver
for
an
inhalation
toxicity
study.
Lastly,
HED
is
already
using
an
oral
toxicity
endpoint
for
the
inhalation
exposure
scenarios.
However,
the
subchronic
inhalation
toxicity
study
is
considered
more
appropriate
for
risk
assessment.
3.
Requirement
for
a
Special
"
Developmental
Neurotoxicity"
Study.
The
registrant
has
stated
that
the
special
"
developmental
neurotoxicity"
study
(
DNT)
is
not
needed
and
HED's
rationale
is
flawed,
since
DNT
triggers
were
not
met.
They
also
state
that
since
the
DNT
study
is
not
needed,
that
the
Food
Quality
Protection
Act
(
FQPA)
10
x
safety
factor
should
not
be
retained.
HED
agrees
that
there
is
some
confusion
with
regard
to
making
the
request
for
a
Developmental
Neurotoxicity
Study.
In
particular,
this
study
should
not
have
been
called
a
Developmental
Neurotoxicity
Study
but
more
correctly
a
Special
Developmental
Toxicity
Study.
3
To
help
clarify
this
issue,
the
registrant
is
now
being
asked
to
develop
a
protocol
for
a
Special
Developmental
Toxicity
study
that
will
assess
for
possible
effects
of
fenarimol
on
the
rat
hormonal
systems.
This
protocol
will
follow
the
same
dosing
regimen
during
gestation
and
lactation
that
is
normally
used
for
the
developmental
neurotoxicity
study.
The
pups
should
then
be
examined
for
potential
hormonal
effects
such
as
levels
of
circulating
androgens
and
estrogens
and
close
examination
of
target
organs
for
androgens
and
estrogens
as
well
as
behavioral
modifications
related
to
hormonal
imbalance
that
might
result
from
fenarimol.
Should
there
be
any
particular
parameters
in
the
FOB
paradigm
that
might
be
used
to
assess
for
hormonal
disruption,
then
these
parameters
should
remain
in
the
special
developmental
toxicity
study
protocol
for
fenarimol.
Additional
parameters
specific
for
assuring
that
fenarimol
does
not
affect
systems
related
to
development
as
influenced
by
the
hormonal
system
may
also
need
to
be
included.
For
example,
the
rat
pups
may
need
to
be
allowed
to
reach
adulthood
and
be
assessed
for
reproductive
performance
to
assure
that
in
utero
exposure
to
fenarimol
did
not
affect
sexual
development.
HED
acknowledges
that
inclusions
of
hormonal
endpoints
in
a
special
developmental
toxicity
study
protocol
is
a
departure
from
the
current
harmonized
guidelines.
However,
since
the
critical
endpoint
for
risk
assessment
for
fenarimol
is
based
on
the
effects
of
this
chemical
on
aromatase
an
enzyme
critical
to
hormone
metabolism,
HED
believes
it
has
the
responsibility
under
FQPA
to
require
additional
testing
to
demonstrate
potential
toxicity
during
fetal
and
neonatal
development
related
to
hormonal
effects.
The
registrant
is
strongly
advised
to
submit
the
protocol
to
the
Agency
prior
to
initiating
the
study.
The
issue
of
appropriateness
of
retaining
the
10x
FQPA
safety
factor
will
also
be
addressed
by
the
HIARC
in
terms
of
evolving
policies
regarding
incomplete
data
bases.
1.
Dermal
Absorption
Factor.
The
Gowan
Company
disagrees
with
the
Agency's
recommendations
to
use
a
20%
dermal
absorption
factor
in
dermal
exposure
risk
assessments.
The
Gowan
Company
provided
a
rationale
and
supporting
data
to
demonstrate
a
lower
dermal
absorption
factor
of
2.6%
is
appropriate.
It
was
indicated
that
if
this
lower
dermal
absorption
factor
is
formally
approved
by
HED,
then
dermal
MOEs
would
be
increased
approximately
seven
fold.
The
registrant
also
provided
additional
information
that
was
requested
by
HED
for
the
monkey
dermal
absorption
study.
ReRegistration
Branch
III
has
incorporated
the
information
provided
for
the
monkey
study
into
an
updated
DER.
The
issue
of
selecting
the
dermal
absorption
factor
for
fenarimol
will
be
discussed
in
a
special
peer
review
HIARC
meeting
within
the
next
several
weeks.
The
updated
DER
for
the
monkey
study,
the
commentary
by
the
European
Union
and
the
registrant's
other
suggestions
related
to
the
selection
of
the
dermal
absorption
factor
will
be
considered
in
this
peer
review
process.
| epa | 2024-06-07T20:31:43.797295 | regulations | {
"license": "Public Domain",
"url": "https://downloads.regulations.gov/EPA-HQ-OPP-2002-0250-0011/content.txt"
} |
EPA-HQ-OPP-2002-0250-0012 | Supporting & Related Material | "2002-09-24T04:00:00" | null | UNITED
STATES
ENVIRONMENTAL
PROTECTION
AGENCY
WASHINGTON,
D.
C.
20460
PC
Code:
206600
DP
Barcode
D282389
DATE:
May
3,
2002
MEMORANDUM
SUBJECT:
Response
to
Registrant's
30
Day
Error
Comments
on
the
Drinking
Water
Assessment
and
Aqueous
Photolysis
Photodegradation
of
Fenarimol
FROM:
E.
Laurence
Libelo,
Ph.
D.,
Environmental
Engineer
Norman
B.
Birchfield,
Ph.
D.
Biologist
Environmental
Risk
Branch
IV
Environmental
Fate
and
Effects
Division
(
7507C)
THROUGH:
Elizabeth
Behl,
Chief
Environmental
Risk
Branch
IV,
Environmental
Fate
and
Effects
Division
(
7507C)
TO:
Tom
Myers,
Product
Manager
Reregistration
Branch
II,
SRRD
(
7508C)
Gowan
has
submitted
comments
on
the
EFED
Drinking
Water
Assessment
to
Support
the
TRED
for
fenarimol.
The
few
comments
on
estimated
drinking
water
exposure
are
general
criticisms
of
the
tools,
approaches
and
policies
used
by
the
Agency
to
estimate
pesticide
concentrations
in
drinking
water.
The
registrant
states
the
results
of
the
FIRST
model
is
not
adequate
to
support
"
risk
mitigation
decisions".
Gowan
supports
this
position
by
stating
that
the
FIRST
model
is
a
screening
model
and
that
an
earlier
Gowan
submission
suggests
that
monitored
concentrations
in
a
study
on
organophosphates
are
substantially
lower
than
EFED
modeling
results.
EFED
agrees
that
there
is
a
large
amount
of
uncertainty
in
the
EECs
produced
using
the
Tier
I
screening
model
FIRST.
FIRST,
and
other
models
used
in
EFED
risk
assessments
have
been
reviewed
by
the
Science
Advisory
Panel,
and
it
is
a
standard,
accepted
tool
for
generating
initial,
conservative
EECs.
In
contrast
to
Gowan's
statement
that
EFED
uses
a
pond
scenario
to
estimate
drinking
water
exposures,
FIRST
models
pesticides
applied
to
a
vulnerable
agricultural
watershed
which
drains
into
a
drinking
water
reservoir.
The
Agency
routinely
uses
FIRST
modeling
in
screening
level
assessments
and
if
levels
of
concern
are
exceeded
more
refined
modeling
is
typically
used
to
refine
estimates.
However,
the
FIRST
model
(
as
well
and
PRZM
and
EXAMS)
requires
a
certain
amount
of
information
to
be
input
on
the
persistence
and
mobility
2
of
a
pesticide.
Typically
these
inputs
are
derived
from
CFR
part
158
data
required
in
support
of
registration.
In
the
case
of
fenarimol,
this
data
is
lacking.
Until
data
on
the
fate
and
transport
of
the
compound
is
submitted
it
is
not
possible
to
refine
the
assessment
using
higher
tier
models.
An
initial
attempt
to
use
PRZM/
EXAMS
modeling
with
the
current
lack
of
data
has
shown
that
"
refinement"
may
result
in
an
increase
in
the
drinking
water
exposure
values
by
more
than
an
order
of
magnitude.
EFED
does
not
believe
that
a
refinement
would
be
meaningful
at
this
point
in
time
given
the
lack
of
required
basic
data;
with
the
current
lack
of
reliable
data
it
is
not
possible
to
determine
drinking
water
concentrations
with
any
reasonable
level
of
certainty.
EFED
has
requested
that
additional
data
be
provided
to
fulfill
the
basic
core
data
requirements
for
this
compound.
Upon
submission
of
adequate
data
more
refined
modeling
may
be
used
to
better
estimate
fenarimol
concentrations
in
drinking
water.
In
addition
to
the
uncertainty
around
fenarimol
concentrations
in
drinking
water
there
is
also
substantial
uncertainty
regarding
the
occurrence,
identity
and
concentration
of
fenarimol
degradates.
Only
one
of
the
degradates
formed
in
the
aqueous
photolysis
study
has
been
identified.
This
degradate,
4
chloro
2(
5
pyrimidyl)
2'
clorobenzophenone,
was
deemed
to
be
of
toxicological
concern
by
the
Health
Effects
Division's
MARC
panel.
Gowan
has
supplied
no
data
on
the
mobility,
persistence
or
toxicity
of
this
degradate.
In
their
comments
the
registrant
states
that
this
degradate
is
one
of
many
unknown
degradates
which
form
as
a
result
of
aqueous
photolysis.
The
lack
of
identification
and
assessment
of
these
compounds
increases
the
uncertainty
in
this
assessment.
A
default
Percent
Cropped
Area
(
PCA)
factor
of
0.87
should
be
applied
to
the
surface
water
EECs
as
the
registrant
indicated.
This
has
resulted
in
recalculated
EEC
values
that
are
slightly
lower
then
initially
modeled.
Using
this
PCA,
the
new,
highly
uncertain
EEC
values
for
surface
water
are:
211
ppb
for
the
acute
and
51
ppb
for
the
chronic
drinking
water
exposure
values.
These
values
represent
the
1
in
10
year
peak
surface
water
concentration
and
1
in
10
year
mean
yearly
concentration
based
on
very
limited
data
for
estimating
the
magnitude
and
duration
of
exposure.
This
concentration
applies
to
fenarimol
alone
(
insufficient
data
exists
to
model
the
photodegradate
of
toxicological
concern).
The
registrant
makes
reference
to
the
formation
and
information
on
the
identity
of
"
more
then
80"
degradates.
This
and
any
other
data
which
may
be
used
to
better
understand
the
environmental
behavior
of
fenarimol
and
its
degradates
should
submitted
to
the
Agency.
Similarly,
the
monitoring
study
conducted
by
the
CDC
that
the
registrant
refers
to
in
their
comments
should
be
submitted.
| epa | 2024-06-07T20:31:43.800409 | regulations | {
"license": "Public Domain",
"url": "https://downloads.regulations.gov/EPA-HQ-OPP-2002-0250-0012/content.txt"
} |
EPA-HQ-OPP-2002-0250-0013 | Supporting & Related Material | "2002-09-24T04:00:00" | null | UNITED
STATES
ENVIRONMENTAL
PROTECTION
AGENCY
WASHINGTON,
D.
C.
20460
OFFICE
OF
PREVENTION,
PESTICIDES
AND
TOXIC
SUBSTANCES
February
12,
2002
MEMORANDUM
SUBJECT:
Fenarimol.
HED
Human
Health
Assessment
for
the
Tolerance
Reassessment
Eligibility
Decision
(
TRED).
Chemical
No.
206600.
No
MRID
#.
DP
Barcode
No.
D280863.
FROM:
Barry
O'Keefe,
Residential
Exposure
Assessor/
Risk
Assessor
John
Doherty,
Toxicologist
Danette
Drew,
Chemist
Reregistration
Branch
3
Health
Effects
Division
(
7509C)
THRU:
Catherine
Eiden,
Branch
Senior
Scientist
Reregistration
Branch
3
Health
Effects
Division
(
7509C)
TO:
Tom
Myers,
Chemical
Review
Manager
Special
Review
and
Reregistration
Division
(
7508C)
This
memorandum
and
attachments
are
the
Health
Effects
Division's
Tolerance
Reassessment
Eligibility
Decision
Document
(
TRED)
for
fenarimol,
taking
into
consideration
requirements
of
the
1996
Food
Quality
Protection
Act
(
FQPA).
This
assessment
only
discusses
the
human
health
risk
assessment
required
for
reassessment
of
tolerances
and
does
not
include
an
occupational
risk
assessment
required
for
reregistration
of
products.
Fenarimol
was
registered
after
1984,
so
it
is
not
subject
to
reregistration
under
FIFRA
88.
However,
fenarimol
is
subject
to
tolerance
reassessment
under
the
FQPA.
When
fenarimol
undergoes
product
reregistration,
SRRD
should
insure
that
all
product
labels
are
in
compliance
with
the
worker
protection
standard
(
WPS).
Cumulative
risk
assessment
considering
risks
from
other
pesticides
which
may
have
a
common
mechanism
of
toxicity
is
also
not
addressed
in
this
document.
Attachments:
Hazard
Identification
Review
Committee
(
HIARC)
report
(
J.
Doherty,
9/
5/
01)
FQPA
Committee
Report
(
B.
Tarplee,
9/
28/
01)
Mechanism
of
Toxicity
Committee
(
METARC)
report
(
J.
Doherty,
9/
17/
01),
Toxicology
Chapter
(
J.
Doherty,
D275392,
10/
12/
01)
Chemistry
Chapter
(
D.
Drew,
D277505,
10/
18/
01)
Dietary
Exposure
Analysis
(
D.
Drew,
D278898,
11/
19/
01)
Metabolism
Assessment
Review
Committee
report
(
D.
Drew,
D277692,
9/
17/
01)
2
Residential
Exposure
Analysis
(
B.
O'Keefe,
D280935,
2/
12/
02)
Drinking
Water
Assessment
to
Support
the
TRED
for
Fenarimol
(
L.
Libelo,
8/
6/
01).
1.0
EXECUTIVE
SUMMARY
Fenarimol
is
a
member
of
the
pyrimidine
class
of
fungicides,
which
also
includes
dimethirimol,
bupirimate,
and
ethirimol.
It
is
the
only
member
of
this
class
registered
for
use
in
the
U.
S.
Fenarimol
is
a
localized
systemic
foliar
fungicide
used
for
control
of
such
pests
as
scab,
powdery
mildew,
rusts,
and
leaf
spot.
Fenarimol
inhibits
fungal
growth
by
adversely
affecting
the
formation
of
the
fungal
sterol
ergosterol.
The
chemical
name
of
fenarimol
is
alpha(
2
chlorophenyl)
alpha(
4
chlorophenyl)
5
pyrimidinemethanol.
Use
Profile
Fenarimol
is
currently
registered
for
use
on
the
following
fruit
and
nut
crops:
apples,
cherries,
filberts,
grapes,
pears,
bananas
and
pecans.
It
is
also
registered
for
use
on
ornamental
plants,
trees,
and
grasses
and
turf
lawns.
The
registration
of
fenarimol
is
being
supported
by
Dow
AgroSciences
LLC.
Fenarimol
total
domestic
usage
for
years
1990
1999
averaged
approximately
61,000
pounds
active
ingredient.
Its
largest
markets,
in
terms
of
total
pounds
active
ingredient
(
ai),
are
allocated
to
apples
(
33%),
outdoor
nurseries
(
20%),
turf
for
lawns
(
16%),
and
turf
for
golf
courses
(
12%).
The
remaining
usage
is
primarily
on
raisin
and
wine
grapes,
cherries,
filberts,
and
pears.
Crops
with
a
high
percentage
of
the
total
U.
S.
planted
acres
treated
include
apples
(
25%),
raisin
grapes
(
21%),
sweet
cherries
(
13%),
tart
cherries,
wine
grapes,
and
filberts
(
9%
each),
and
table
grapes
(
8%).
Fenarimol
formulations
include
granular
(
0.78%
ai,
turf
use
only),
soluble
concentrate/
liquid
(
11.6%
ai),
flowable
concentrate
(
2.4%
ai)
and
emulsifiable
concentrates
(
11.6%
ai
and
12%
ai).
Although
some
end
use
products
have
label
restrictions
and
wording
indicative
of
non
home
owner
use,
fenarimol
is
not
a
restricted
use
pesticide
and
can
be
purchased
and
applied
by
anyone.
However,
only
the
granular
formulation
is
assumed
to
be
applied
by
residents.
Additionally,
only
applications
to
lawns
and
turf
are
expected
to
result
in
residential
exposures.
Hazard
Identification
and
Dose
Response
Assessment
The
toxicity
database
for
fenarimol
is
substantially
complete,
with
the
following
data
gaps
identified:
Dermal
Irritation
Study
(
870.2400);
Subchronic
Inhalation
Study
(
870.3465);
and
Developmental
Neurotoxicity
Study
(
870.6300).
Fenarimol
has
moderate
acute
toxicity
via
the
oral,
dermal
or
inhalation
routes
(
all
Category
III).
Fenarimol
causes
corneal
opacity
in
rabbit
eyes
(
Category
II).
There
are
no
data
on
dermal
irritation.
Fenarimol
was
not
shown
to
be
a
contact
dermal
sensitizer
in
the
guinea
pig.
The
rat
metabolism
study
indicates
that
following
oral
administration,
fenarimol
is
rapidly
absorbed
and
excreted,
with
the
biliary
route
being
the
major
route
of
excretion.
Subchronic
oral
dosing
in
rats
demonstrates
very
little
toxicity
except
for
some
slight
body
weight
changes
and
liver
pathology
of
low
degree
and
consistency
(
liver
weight
increase
and
fatty
liver).
In
dogs,
there
was
little
overt
toxicity.
Dermal
absorption
was
estimated
to
be
20%
based
on
a
weight
3
of
the
evidence
assessment
using
rabbit
and
monkey
dermal
absorption
studies
along
with
a
comparison
of
the
rabbit
oral
developmental
toxicity
and
rabbit
21
day
dermal
toxicity
studies.
The
liver
is
the
most
evident
target
organ
for
chronic
toxicity,
aside
from
the
effects
of
fenarimol
on
aromatase.
Liver
toxicity
was
manifested
by
liver
weight
increases
and
the
presence
of
"
fatty
liver"
in
rats.
In
dogs,
liver
weight
was
increased
and
there
were
also
increases
in
serum
enzymes
indicative
of
liver
toxicity.
The
data
base
for
carcinogenicity
is
considered
complete.
Fenarimol
has
been
classified
as
a
"
not
likely"
human
carcinogen
(
Group
E).
The
mutagenicity/
genetic
toxicity
data
base
is
considered
complete
and
indicates
no
mutagenicity
concern.
The
data
base
for
prenatal
developmental
and
reproductive
toxicity
is
considered
complete.
The
developmental
and
reproductive
toxicity
studies
showed
no
evidence
of
increased
sensitivity
or
susceptibility
of
young
rats
or
rabbits
following
pre
or
postnatal
exposure
to
fenarimol.
The
studies
demonstrated
that
fenarimol
is
associated
with
hydronephrosis
that
is
reversible.
The
most
prominent
aspect
of
fenarimol
toxicity
was
evident
in
the
rat
multi
generation
reproduction
studies
and
relates
to
inhibition
of
aromatase.
Aromatase,
also
known
as
estrogen
synthetase,
is
the
key
enzyme
for
the
conversion
of
androgens
to
estrogens
and
is
therefore
a
potentially
critical
enzyme
in
maintaining
hormone
balance
in
human
physiology.
Without
aromatase,
there
could
potentially
be
deficits
in
estrogens
which
are
important
for
a
variety
of
physiological
functions.
Estrogens
are
largely
responsible
for
the
changes
that
take
place
during
puberty
in
human
females
and
affect
secondary
sexual
characteristics.
It
is
also
recognized
that
aromatase
deficient
males
do
not
develop
normal
skeletal
characteristics.
The
Mechanism
of
Toxicity
Assessment
Review
Committee
(
METARC)
met
to
evaluate
the
data
concerning
fenarimol's
effects
on
aromatase
and
their
decision
memorandum
contains
a
more
detailed
discussion
of
aromatase
(
J.
Doherty,
9/
16/
01).
The
multi
generation
reproduction
studies
indicate
that
fenarimol
causes
reduced
fertility
and
dystocia
(
difficult
labor).
Separate
cross
dosing
studies
(
dosing
males
and
mating
with
untreated
females
and
dosing
females
and
mating
with
untreated
males)
indicated
that
the
reduced
fertility
is
due
to
an
effect
in
males
and
the
dystocia
is
an
effect
in
females.
These
effects
of
fenarimol
were
demonstrated
to
be
attributed
to
inhibition
of
aromatase.
The
decrease
in
fertility
in
males
results
from
the
decreased
conversion
of
testosterone
(
an
androgen)
to
estradiol
which
is
essential
for
male
sexual
development.
The
increase
in
dystocia
in
rats
was
also
attributed
to
inhibition
of
aromatase
because
in
the
rat,
progesterone
is
converted
to
estrogen
by
aromatase
to
facilitate
parturition.
The
FQPA
required
the
Agency
to
consider
potential
special
sensitivity
to
infants
and
children
from
exposure
to
fenarimol.
Submitted
toxicity
studies
showed
that
there
is
no
increased
sensitivity
or
susceptibility
to
infants
and
children
based
mainly
on
the
results
of
the
developmental/
reproductive
toxicity
studies.
However,
a
developmental
neurotoxicity
study
is
required
to
determine
if
the
potential
hormonal
effects
as
elicited
by
inhibition
of
aromatase
will
result
in
effects
in
offspring.
Additionally,
the
environmental
fate
database
is
incomplete
for
the
aquatic
photolytic
degradate
of
fenarimol,
4
chloro
2(
5
pyrimidyl)
2'
chlorobenzophenone.
A
screening
level
drinking
water
assessment
which
includes
this
degradate
of
potential
toxicological
concern
is
not
possible
at
this
time.
Therefore,
the
FQPA
committee
determined
that
the
10x
FQPA
factor
should
be
retained
for
all
fenarimol
risk
assessments.
4
The
METARC
recommended,
and
the
HIARC
confirmed,
that
the
reduced
male
fertility
and
dystocia
effects
of
fenarimol
should
be
endpoints
for
human
health
risk
assessment.
It
is
noted
that
the
endpoint
from
the
multi
generation
reproduction
study
is
based
on
decreased
litter
size.
This
decrease
in
litter
size
may
be
a
reflection
of
the
maternal
toxicity
(
dystocia)
or
the
potential
for
fenarimol
to
inhibit
aromatase
in
males
(
reduced
fertility).
Because
both
males
and
females
are
affected,
the
toxicological
endpoint
from
the
multi
generation
reproduction
study
is
applicable
to
all
populations.
After
examining
all
of
the
available
toxicity
data,
the
HIARC
concluded
that
an
acute
toxicity
endpoint
and
dose
for
risk
assessment
could
not
be
identified.
That
is,
no
appropriate
endpoint
was
available
to
quantitate
risk
to
the
general
population
or
females
13
50
years
old
from
a
single
dose
administration
of
fenarimol.
Although
hydronephrosis
seen
in
the
rat
developmental
and
multigeneration
reproductive
toxicity
studies
had
been
identified
as
an
acute
adverse
toxic
effect
(
endpoint)
in
earlier
fenarimol
risk
assessments,
the
HIARC
concluded
that
it
is
not
appropriate
because:
1)
the
hydronephrosis
is
not
severe
(
its
is
considered
low
degree);
2)
the
hydronephrosis
was
shown
to
be
reversible;
3)
the
hydronephrosis
developed
after
multiple
exposures
and
there
is
no
indication
that
it
would
develop
following
a
single
exposure;
and,
4)
the
hydronephrosis
may
be
related
to
a
developmental
delay
and
not
a
target
specific
effect
of
fenarimol.
The
HIARC
identified
a
reference
dose
for
chronic
exposure
(
cRfD)
of
0.006
mg/
kg/
day
from
the
multi
generation
reproduction
study
based
on
a
no
observed
adverse
effect
level
(
NOAEL)
of
0.6
mg/
kg/
day,
and
a
10X
uncertainty
factor
for
interspecies
extrapolation
and
a
10X
uncertainty
factor
for
intraspecies
variation.
The
NOAEL
of
0.6
mg/
kg/
day
is
based
on
decreased
live
born
litter
size
in
the
F
1
and
F
2
generations
at
a
lowest
observed
adverse
effect
level
(
LOAEL)
of
1.2
mg/
kg/
day.
HED
calculated
a
chronic
Population
Adjusted
Dose
(
cPAD)
of
0.0006
mg/
kg/
day.
The
cPAD
is
the
RfD
divided
by
the
FQPA
safety
factor
(
10X).
Chronic
dietary
exposure
estimates
greater
than
100%
of
the
cPAD
would
exceed
HED's
level
of
concern.
The
endpoint
and
dose
was
also
used
for
the
intermediate
term
(
1
6
months)
incidental
oral,
dermal,
and
inhalation
risk
assessments.
A
Margin
of
Exposure
or
MOE,
which
is
the
ratio
of
the
NOAEL
to
the
exposure
estimate,
of
greater
than
1000
does
not
exceed
HED's
level
of
concern
for
these
risk
assessments.
An
MOE
of
greater
than
1000
is
required
for
these
intermediate
term
exposure
scenarios
because
of
the
10x
interspecies
factor,
the
10x
intraspecies
factor
and
the
10x
FQPA
factor.
Because
the
same
endpoint
was
used
for
all
intermediate
term
exposure
assessments,
the
risk
estimates
for
the
various
routes
of
exposure
may
be
aggregated.
For
the
short
term
(
1
30
day)
incidental
oral,
dermal,
and
inhalation
risk
assessments,
a
LOAEL
of
35
mg/
kg/
day
was
selected.
This
endpoint
is
based
on
decreased
fertility
and
dystocia,
an
indicator
of
hormonal
effects,
observed
in
a
special
non
guideline
cross
breeding
reproduction/
developmental
toxicity
study
in
rats.
Because
a
LOAEL
is
used
an
additional
3x
uncertainty
factor
was
applied.
Therefore,
a
MOE
greater
than
3000
does
not
exceed
HED's
level
of
concern
for
short
term
risk
assessments.
Because
the
same
endpoint
was
used
for
all
short
term
exposure
assessments,
the
risk
estimates
for
the
various
routes
of
exposure
may
be
aggregated.
Exposure
and
Risk
Assessment
Dietary
Exposure
and
Risk
Estimates
5
The
residue
chemistry
database
for
fenarimol
is
substantially
complete
and
is
adequate
for
tolerance
reassessment.
The
Metabolism
Assessment
Review
Committee
(
MARC)
has
determined
that
for
enforcement
purposes,
the
tolerance
for
plant
commodities
should
be
expressed
as
parent
only.
However
the
dietary
assessment
for
grapes
and
bananas
should
include
the
metabolites
[
alpha(
2
chlorophenyl)
alpha(
4
chlorophenyl)
1,4
dihydro
5
pyrimidinemethanol]
and
(
5[
2
chlorophenyl)
(
4
chlorophenyl)
methyl]
3,4
dihydro
4
pyrimidinol]),
because
of
their
structural
similarity
to
fenarimol.
The
residue
of
concern
in
livestock
commodities
is
fenarimol
per
se.
Tolerances
for
fenarimol
are
generally
low,
ranging
from
0.01
to
1.0
ppm
Because
an
acute
toxicity
endpoint
was
not
identified,
an
acute
dietary
exposure
assessment
was
neither
required
nor
conducted.
The
chronic
dietary
exposure
assessment
for
fenarimol
is
highly
refined
using
anticipated
residues
based
on
Food
and
Drug
Administration
(
FDA)
monitoring
data
for
apples,
bananas,
cherries,
grapes
and
pears.
There
were
no
USDA
Pesticide
Data
Program
(
PDP)
monitoring
data
available
for
fenarimol.
The
FDA
monitoring
data
indicated
no
detectable
residues
for
apples,
bananas,
grapes
and
pears.
Field
trial
residue
data
were
used
for
pecans
and
filberts.
Percent
crop
treated
(%
CT)
information
and
processing
factors,
where
available,
were
used
in
the
assessment.
Anticipated
residues
were
calculated
for
cattle
meat,
fat,
and
meat
by
products.
Wet
apple
pomace
is
the
only
animal
feed
item
associated
with
the
registered
uses
of
fenarimol.
There
are
no
poultry
or
hog
feedstuffs.
Milk
was
classified
as
Category
3
of
40
CFR
180.6(
a)
that
is,
there
is
no
reasonable
expectation
of
finite
residues.
Chronic
dietary
risk
estimates
are
provided
for
the
general
U.
S.
population
and
various
population
subgroups.
This
assessment
concludes
that
for
all
supported
registered
commodities,
the
chronic
risk
estimates
are
below
the
HED's
level
of
concern
(<
100%
of
the
chronic
population
adjusted
dose,
cPAD)
for
the
general
U.
S.
population
and
all
population
subgroups.
Dietary
(
food)
exposure
estimates
were
all
very
low
(
all
<
1%
of
the
cPAD).
This
is
not
surprising
based
on:
the
lack
of
detectable
residues
for
many
commodities
in
the
FDA
monitoring
data;
no
residues
expected
in
milk,
poultry
and
hogs;
and,
low
anticipated
residues
for
cattle
meat,
fat,
and
meat
by
products.
Environmental
fate
data
show
that
fenarimol
is
persistent
and
mobile
in
the
environment.
In
field
studies,
fenarimol
dissipated
with
half
lives
of
3
months
to
several
years
from
soil
and
turf
surfaces.
Fenarimol
is
stable
to
hydrolysis,
anaerobic
microbial
degradation
and
photolysis
on
soil.
It
is
degraded
very
slowly,
if
at
all,
by
aerobic
microbial
processes
with
reported
mean
aerobic
soil
metabolism
half
life
of
about
4
years.
It
is
degraded
by
photolysis
in
aqueous
solution.
The
primary
photolysis
product
was
4
chloro
2(
5
pyrimidyl)
2'
clorobenzophenone.
The
MARC
elected
not
to
exclude
this
degradate
in
the
drinking
water
exposure
assessment
because:
1)
its
potential
to
occur
in
surface
water;
and
2)
the
lack
of
data
to
determine
whether
it
is
of
toxicological
concern.
The
environmental
fate
studies
were
conducted
in
the
1970s
and
early
1980s.
The
quality
of
the
data
provided
by
these
studies
is
significantly
lower
then
currently
required.
By
current
standards
most
of
these
studies
would
not
be
considered
acceptable
and
the
results
would
not
be
considered
of
sufficient
quality
to
allow
a
reasonably
accurate
assessment
of
the
environmental
fate
of
this
compound.
Therefore,
the
estimated
environmental
concentrations
(
EECs)
presented
here
are
somewhat
uncertain,
and
may
change
substantially
when
better
data
become
available.
It
is
not
possible,
using
the
existing
data,
to
provide
a
more
refined
assessment.
To
estimate
risks
from
exposure
to
fenarimol
residues
potentially
present
in
drinking
water,
HED
has
6
compared
EECs
for
fenarimol
in
surface
water
and
groundwater
to
calculated
drinking
water
levels
of
comparison
(
DWLOCs).
The
DWLOC
chronic
is
the
concentration
in
drinking
water
as
a
part
of
the
aggregate
chronic
exposure
that
occupies
no
more
than
100%
of
the
cPAD
when
considered
together
with
other
sources
of
exposure.
If
the
EECs
are
greater
than
the
DWLOCs,
there
is
a
potential
drinking
water
concern.
Screening
level
assessments,
using
conservative
modeling
to
estimate
highend
average
concentrations
(
EECs)
of
fenarimol
in
surface
water
and
groundwater,
were
conducted
by
the
Environmental
Fate
and
Effects
Division
(
EFED).
Tier
I
modeling
was
performed
for
both
surface
water
(
FIRST
model)
and
groundwater
(
SCI
GROW
model).
EFED
modeled
the
turf
application
use
scenario
in
both
cases.
A
Tier
II
model
is
not
available
for
turf.
Upon
comparison
of
the
chronic
DWLOCs
with
the
chronic
EECs,
average
concentrations
of
fenarimol
in
surface
and
groundwater
are
greater
than
the
DWLOCs
for
several
populations.
For
surface
water,
EECs
were
approximately
3
to
10
times
higher
than
the
DWLOC
chronic.
For
those
populations
with
ground
water
EECs
greater
than
the
DWLOC
chronic,
the
EECs
were
approximately
2
times
higher
than
the
DWLOCs.
Consequently,
there
is
a
potential
concern
for
chronic
exposure
through
drinking
water
from
surface
water
sources
for
all
populations,
and
for
infants
and
children
from
groundwater
sources.
Residential
Exposure
and
Risk
Estimates
Potential
residential
exposures
may
occur
as
a
result
of
applications
of
fenarimol
to
residential
lawns
or
turf
by
residents
and
by
professional
lawn
care
operators
(
LCOs).
Residential
exposures
have
been
estimated
based
on
label
application
rates
and
frequency,
and
the
persistence
of
fenarimol.
The
following
use
patterns
have
been
assessed
for
non
occupational
(
residential)
handler
exposures:
1)
granular
application
to
turf
with
a
belly
grinder
spreader;
2)
granular
application
to
turf
with
a
pushtype
spreader;
and
3)
granular
spot
treatment
to
turf
by
hand.
The
short
term
risks
to
residential
handlers
were
assessed
using
the
updated
draft
Standard
Operating
Procedures
(
SOPs)
for
Residential
Exposure
Assessment,
and
includes
surrogate
data
from
the
Pesticide
Handlers
Exposure
Database
(
PHED)
for
loading/
applying
with
a
belly
grinder
type
granular
spreader
and
applying
by
hand,
and
the
Outdoor
Residential
Exposure
Task
Force
(
ORETF)
for
loading/
applying
with
a
push
type
granular
spreader.
The
ORETF
data
are
recent
high
quality
studies.
The
data
used
for
the
hand
dispersal
and
belly
grinder
type
granular
spreader
are
not
as
high
quality.
Central
tendency
exposure
data
were
used
together
with
the
label
maximum
rate
for
short
term
exposures,
so
the
assessment
is
considered
protective
for
most
uses,
but
not
conservative.
For
residential
adult
handlers
applying
granular
product
to
turf,
risk
estimates
for
short
term
dermal
exposures
exceed
HED's
level
of
concern
(
MOEs
are
less
than
3000)
for
the
scenarios
of
a
belly
grinder
type
spreader
or
by
hand
dispersal
for
spot
treatments.
However,
for
the
other
short
term
handler
exposures
to
fenarimol
(
using
a
push
type
spreader),
HED's
level
of
concern
is
not
exceeded,
i.
e.
all
risk
estimates
(
MOEs)
are
3000
or
greater.
Several
post
application
exposure
scenarios
following
application
to
turf
are
anticipated;
these
are
as
follows:
1)
short
and
intermediate
(
1
6
months)
term
dermal
exposure
to
adults
and
children
(
toddlers);
2)
incidental
episodic
oral
exposure
to
children
from
ingestion
of
fenarimol
granules;
and
3)
short
and
intermediate
term
oral
exposure
to
children
from
incidental
ingestion
of
soil,
turf
grass
mouthing,
and
hand
to
mouth
activity.
These
exposures
could
occur
whether
a
professional
or
resident
applied
fenarimol.
The
updated
Residential
SOPs
were
used
to
address
the
exposures
of
children
contacting
treated
turf.
7
The
SOPs
for
turf
use
a
high
contact
activity
based
on
the
use
of
Jazzercise
®
to
represent
the
exposures
of
an
actively
playing
child
or
active
adult.
Lower
contact
activities,
such
as
walking,
mowing,
or
golfing,
for
example,
use
transfer
coefficients
based
on
mowing
studies.
Chemical
specific
data
from
a
turf
transferable
residue
(
TTR)
study
were
available
and
were
used
to
estimate
the
dissipation
of
fenarimol.
Dislodgeable
foliar
residue
(
DFR)
data
were
also
available
for
apple
trees.
These
apple
DFR
data
support
the
EFED
conclusions
concerning
the
persistence
of
fenarimol
in
the
environment.
In
the
DFR
study,
detectable
residues
were
still
present
on
leaf
surface
65
days
after
treatment.
Risk
estimates
for
short
term
dermal
contact
with
treated
turf
during
high
contact
lawn
activities
on
day
zero
following
application
exceed
HED's
estimated
level
of
concern
for
adults
and
toddlers
(
MOEs
of
240
and
170,
respectively).
For
low
contact
activities
(
such
as
grass
mowing
or
golfing
),
MOEs
did
not
exceed
the
level
of
concern.
Risk
estimates
for
intermediate
term
dermal
contact
with
treated
turf
had
a
similar
pattern;
i.
e.
risk
estimates
exceeded
the
level
of
concern
for
high
contact
lawn
activities
(
MOE
of
360
for
adults,
250
for
toddlers).
Risk
estimates
for
adults,
however,
were
below
the
level
of
concern
for
the
low
contact
activities
of
golfing
and
mowing.
HED
assessed
short
term
exposures
of
small
children
following
application
of
fenarimol
to
residential
lawns,
including
exposures
from
incidental
episodic
ingestion
of
fenarimol
granules,
and
exposures
from
incidental
ingestion
of
fenarimol
residues
from
turf
grass
mouthing,
hand
to
mouth
activity,
and
soil
ingestion.
The
risk
estimates
for
small
children's
ingestion
of
fenarimol
from
treated
turf
indicate
that
risks
exceed
the
level
of
concern
(
MOEs
less
than
3000)
for
ingestion
of
granules
(
MOE
=
220)
and
hand
to
mouth
(
MOE
=
860).
However,
HED
considers
the
incidental
episodic
risk
of
ingestion
of
fenarimol
granules
to
be
unlikely
given
the
smaller
particle
size
of
fenarimol
granules
and
the
fact
that
watering
in
should
occur
immediately
or
soon
after
application
in
order
for
the
pesticide
to
be
efficacious.
Incidental
ingestion
of
soil
and
incidental
turf
grass
mouthing
did
not
exceed
the
level
of
concern.
The
small
children's
combined
oral
hand
to
mouth
scenarios
(
except
granular
ingestion)
also
exceeds
the
level
of
concern
(
MOE
=
685).
When
risk
estimates
for
small
children
from
shortterm
dermal
exposures
are
combined
with
risk
estimates
from
short
term
incidental
oral
exposures
(
except
granular
ingestion),
the
combined
short
term
MOE
exceeds
the
level
of
concern
(
MOE
=
140).
Based
upon
the
slow
dissipation
rate
of
fenarimol
and
the
possibility
of
multiple
applications
to
turf,
HED
estimated
risks
for
intermediate
term
exposures
of
small
children
from
incidental
ingestion
of
soil,
hand
to
mouth
transfer,
and
incidental
turf
grass
mouthing.
Intermediate
term
risk
estimates
were
below
the
level
of
concern
for
ingestion
of
soil
(
MOE
=
2400).
However,
the
intermediate
term
risk
estimates
for
the
turf
grass
mouthing
(
MOE
=
320)
and
hand
to
mouth
activities
(
MOE
=
78)
exceed
the
level
of
concern.
The
small
children's
combined
oral
hand
to
mouth
scenarios
(
except
granular
ingestion)
also
exceed
the
level
of
concern
(
MOE
=
62).
When
risks
from
dermal
exposures
from
fenarimol
to
small
children
are
combined
with
risks
from
incidental
oral
exposures,
the
combined
intermediate
term
risk
estimates
exceed
the
level
of
concern
(
MOE
=
50).
These
intermediate
term
incidental
risk
estimates
do
not
account
for
the
fact
that
turf
periodically
receives
irrigation
and/
or
precipitation
and
is
routinely
mowed
resulting
in
the
removal
of
grass
and
residues,
and
therefore,
may
overestimate
exposure.
Additionally,
the
assumption
that
toddlers
will
play
on
turf
for
two
hours
per
day,
for
more
than
30
consecutive
days,
may
be
a
conservative
assumption.
Therefore,
intermediate
term
risks
to
toddlers
playing
on
turf
may
not
be
as
great
of
a
concern
as
the
risk
estimates
indicate.
8
N
N
OH
Cl
Cl
Mitigating
circumstances
for
residential
exposure
to
fenarimol
residues
may
include
watering
in
after
application
to
turf.
This
instruction,
however,
does
not
prevent
contact
with
treated
turf
prior
to
watering
in.
The
current
granular
label
(
EPA
Reg.
No.
228
298)
recommends,
but
does
not
require
watering
in.
The
soluble
concentrate
label
(
EPA
Reg.
No.
62719
142)
does
not
mention
watering
in.
Therefore,
label
language
should
be
strengthened
to
ensure
that
watering
in
occurs
immediately
after
application.
Additionally,
the
current
labeling
does
not
clearly
specify
whether
the
granular
product
(
EPA
Reg.
No.
228
298)
is
for
professional
use
only.
Specific
labeling
would
help
eliminate
unintentional
use
by
residents.
Labeling
should
also
specifically
advise
against
the
hand
dispersal
and
belly
grinder
type
application
methods.
Aggregate
Exposure
and
Risk
Estimates
Because
no
acute
toxicity
endpoint
was
identified
for
risk
assessment,
an
aggregate
acute
risk
assessment
was
not
conducted.
Short
and
intermediate
term
aggregate
risk
estimates
exceed
HED's
level
of
concern.
These
risk
assessments
consider
residential
as
well
as
dietary
(
food
and
water)
exposures.
Because
risk
estimates
for
the
residential
uses
alone
exceed
HED's
level
of
concern,
additional
exposure
from
food
or
drinking
water
would
only
cause
risk
estimates
to
further
exceed
the
level
of
concern.
Chronic
aggregate
risk
estimates
also
exceed
HED's
level
of
concern.
Although
chronic
dietary
(
food)
estimates
are
low
(<
1%
of
the
cPAD),
EECs
for
ground
water
and
surface
water
exceed
DWLOCs
for
several
population
subgroups.
2.0
PHYSICAL
CHEMICAL
PROPERTIES
CHARACTERIZATION
The
chemical
name
for
fenarimol
is
alpha(
2
chlorophenyl)
alpha(
4
chlorophenyl)
5
pyridinemethanol.
The
structure
is
as
follows:
Empirical
Formula:
C
17
H
12
Cl
2
N
2
O
Molecular
Weight:
331.2
CAS
Registry
No.:
60168
88
9
PC
Code:
206600
Fenarimol
is
a
white
to
buff
crystalline
solid
with
a
melting
point
of
117
119
C,
bulk
density
of
0.66
0.81
g/
cc
(
packed),
octanol/
water
partition
coefficient
(
log
K
ow)
of
3.69,
and
vapor
pressure
of
2.2
x
9
10
7
Torr
at
25
C.
Fenarimol
is
practically
insoluble
in
water
(
13.7
ppm
at
pH
7
and
25
C)
and
is
soluble
in
most
organic
solvents:
hexane
(
1.1
mg/
mL);
acetonitrile,
heavy
aromatic
naphtha,
and
xylene
(
50
mg/
mL);
benzene
and
methanol
(
100
125
mg/
mL);
acetone
(>
250
mg/
mL);
and
chloroform
and
cyclohexanone
(>
500
mg/
mL).
3.0
HAZARD
CHARACTERIZATION
3.1
Hazard
Profile
Toxicology
data
are
used
by
HED
to
assess
the
potential
hazards
to
humans.
The
data
are
derived
from
a
variety
of
acute,
subchronic,
and
chronic
toxicity
tests;
developmental/
reproductive
tests;
and
tests
to
assess
mutagenicity
and
pesticide
metabolism.
The
database
for
fenarimol
is
adequate
to
support
this
TRED.
Acute
toxicity
values
and
toxicity
categories
for
fenarimol
are
summarized
in
Table
1.
The
data
indicate
that
fenarimol
has
low
acute
oral,
dermal,
and
inhalation
toxicity
(
category
III).
Fenarimol
is
category
II
with
respect
to
ocular
irritation.
It
is
not
a
dermal
sensitizer.
A
primary
dermal
irritation
study
is
not
available.
Table
1.
Acute
Toxicity
of
Fenarimol.
Study
Type
MRID
No.:
Result
870.1100
Acute
Oral
Toxicity
rat.
Elanco,
Study
No.:
R
O
289
82,
December
30,
1982
00125392
LD50
>
599
mg/
kg.
Toxicity
Category
III
Classification:
Guideline
870.1200
Acute
Dermal
Toxicity
rabbit.
Elanco
Study
No.:
B
D
27
82,
February
17,
1983
00125392
LD50
>
1998
mg/
kg.
Toxicity
Category
III
Classification:
Minimum
870.1300.
Acute
Inhalation
Toxicity
rat.
Elanco,
Study
No.:
R
H
102
82,
November
16,
1982.
00125292
LC50
>
5.20
mg/
L
for
males.
LC50
between
2.87
and
5.2
mg/
L
for
females.
Toxicity
Category
III
Classification:
Guideline
870.2400
Primary
Ocular
Irritation
Rabbit.
Elanco,
Study
No.:
B
E
32
82,
February
1,
1982
00125392
Day
1:
6/
6
corneal
opacity
(
score
of
5);
5/
6
iris
irritation
(
score
5);
6/
6
conjunctival
irritation
(
score
of
1
2).
Day
7:
3/
6
corneal
opacity
and
conjunctival
irritation.
Day
14
all
irritation
cleared.
Toxicity
Category
II
Classification:
Minimum
870.2500
Primary
Dermal
Irritation
rabbit.
No
study
available.
870.2600
Dermal
Sensitization
guinea
pig.
Elanco,
Study
No.;
GP
9538,
January
1,
1980.
00084966
No
evidence
of
sensitization
in
the
Guinea
Pig
Maximization
test
of
Magnusson
and
Kligman.
Classification:
Minimum.
10
Table
2
presents
a
summary
of
subchronic
and
chronic
toxicity
studies
for
fenarimol.
Subchronic
oral
dosing
in
rats
demonstrates
very
little
toxicity
except
for
some
slight
body
weight
changes
and
liver
pathology
of
low
degree
and
inconsistency.
In
dogs
there
was
also
little
overt
toxicity
with
there
being
some
effects
in
the
liver.
A
28
day
subchronic
inhalation
study
is
required.
Adequate
data
are
available
to
assess
the
chronic
toxicity
and
carcinogenic
potential
of
fenarimol.
The
liver
appears
to
be
the
most
evident
target
organ
for
chronic
toxicity
aside
from
the
effects
of
fenarimol
on
aromatase.
Liver
toxicity
was
manifested
by
liver
weight
increases
and
the
presence
of
"
fatty
liver"
in
rats.
In
dogs,
liver
weight
was
increased
and
there
was
also
associated
increases
in
serum
enzymes
to
indicate
liver
toxicity.
p
Nitroanisole
o
demethylase
was
also
increased
indicating
stimulation
of
liver
enzymes.
Fenarimol
has
been
classified
as
a
Group
E
"
not
likely"
carcinogen
(
no
evidence
of
carcinogenicity
for
humans).
Similarly,
the
genetic
toxicity
data
indicate
there
is
no
mutagenicity
concern.
Developmental
studies
in
rats
and
rabbits,
designed
to
identify
possible
adverse
effects
on
the
developing
organism
which
may
result
from
the
in
utero
exposure
to
the
pesticide
were
also
conducted.
The
data
base
for
prenatal
developmental
toxicity
is
considered
complete.
The
initial
guideline
study
was
classified
as
unacceptable,
but
this
study
together
with
a
special
study
to
assess
for
the
reversibility
of
hydronephrosis
are
combined
with
another
special
study
to
assess
for
reproductive
performance.
All
of
these
studies
combine
to
make
an
acceptable
study
and
to
satisfy
the
guideline
requirement.
The
rat
studies
revealed
that
fenarimol
is
associated
with
hydronephrosis
that
is
reversible.
The
developmental
toxicity
studies
showed
no
evidence
of
increased
sensitivity
or
susceptibility
of
young
rats
or
rabbits
following
pre
or
postnatal
exposure
to
fenarimol.
The
data
base
for
reproductive
toxicity
is
considered
complete.
The
multi
generation
reproduction
studies
indicate
that
fenarimol
causes
reduced
fertility
and
dystocia.
Separate
cross
dosing
studies
(
dosing
males
and
mating
with
untreated
females
and
dosing
females
and
mating
with
untreated
males)
indicated
that
the
reduced
fertility
is
due
to
an
effect
in
males
and
the
dystocia
is
an
effect
in
females.
These
effects
of
fenarimol
were
attributed
to
inhibition
of
aromatase
or
the
enzyme
that
converts
androgens
to
estrogens.
In
addition
to
the
guideline
multi
generation
reproduction
study
in
rats,
there
are
nonguideline
studies
that
assess
for
the
reproductive
performance
in
mice
(
MRID
No.:
45502307),
guinea
pigs
(
MRID
No.:
00126525,
00133474
and
00137159)
and
rabbits
(
MRID
No.:
00084967).
The
mouse
study
indicated
that
mice
are
similar
to
rats
in
that
there
is
a
decrease
in
the
reproductive
performance
in
the
males.
However,
neither
the
guinea
pig
or
rabbit
studies
demonstrated
a
decrease
in
reproductive
performance
indicating
that
the
effect
of
fenarimol
on
male
reproductive
performance
is
not
seen
in
all
species
tested.
There
is
no
Guideline
870.7600
dermal
absorption
study
available
with
rats.
The
upper
bound
limit
for
dermal
absorption
was
estimated
to
be
20%
based
on
a
assessment
of
the
rabbit
and
monkey
dermal
absorption
studies
along
with
a
comparison
of
the
rabbit
developmental
toxicity
and
rabbit
21
day
dermal
toxicity
studies.
Refer
to
the
HIARC
report
(
J.
Doherty,
9/
5/
01)
for
a
more
detailed
discussion
of
dermal
absorption.
11
The
database
for
metabolism
is
considered
to
be
complete.
The
biliary
route
is
the
predominant
route
of
elimination
in
the
rat
but
the
urinary
route
is
the
most
prominent
route
of
elimination
in
the
rabbit.
In
rats,
fenarimol
is
rapidly
absorbed
from
the
gastro
intestinal
tract
and
the
half
life
of
the
plasma
level
was
determined
to
be
11.8
to
16.8
hours.
Most
of
the
radiolabeled
material
was
recovered
in
the
urine
(
5
to
15%)
or
feces
(~
80%
of
the
recovered
isotope)
by
day
7.
Biliary
excretion
was
the
major
route
of
elimination.
Fenarimol
is
extensively
metabolized
in
the
rat;
less
than
one
percent
of
the
parent
is
recovered,
while
more
than
30
metabolites
are
recovered.
Metabolism
of
fenarimol
occurs
by
the
oxidation
of
the
carbinol
phenyl
ring
and
pyrimidine
ring
and
some
qualitative
and
quantitative
differences
in
sexes
and
dose
level
were
noted.
There
are
no
acute,
subchronic
or
developmental
neurotoxicity
studies
available.
The
HIARC
(
July
10,
2001)
determined
that
only
a
developmental
neurotoxicity
study
with
special
inclusions
to
assess
for
hormonal
effects
and
in
vivo
inhibition
of
aromatase
should
be
required.
Acute
and
subchronic
neurotoxicity
studies
are
not
required.
The
toxicology
profile
of
fenarimol
is
shown
in
Table
2
of
this
document.
Table
2.
Toxicology
Profile
for
Fenarimol.
Guideline
No./
Study
Type
MRID
No.
(
year)/
Classification
/
Doses
Results
870.3100
(
12
and
18
month
oral
toxicity
rodents
fulfill
this
guideline)
00235175,
45502302
and
45502304
(
1978)/
Acceptable/
Non
Guideline
0,
2.5,
6.5
or
17.5
both
sexes.
NOAEL
=
6.5
mg/
kg/
day
LOAEL
=
17.5
mg/
kg/
day
based
on
increased
relative
liver
weight
and
increased
severity
of
fatty
liver.
870.3150
90
Day
oral
toxicity
in
nonrodents
00056090
(
1975)/
Acceptable/
Guideline
0,
1.25,
5
or
20
mg/
kg/
day.
NOAEL
and
LOAEL
>
20
mg/
kg/
day
(
HDT).
A
one
year
study
(
MRID
00146959
satisfies
this
guideline).
870.3200
21/
28
Day
dermal
toxicity
(
rat)
00153312
(
1985)
Acceptable/
Guideline
0,
500
or
1000
mg/
kg/
day
for
RUBIGAN
(
emulsifiable)
formulation
and
1000
mg/
kg/
day
for
technical
fenarimol.
NOAEL
<
1000
mg/
kg/
day
LOAEL
=
1000
mg/
kg/
day
based
on
slight
liver
weight
effects.
Although
this
study
is
acceptable,
it
is
of
limited
usefulness
for
risk
assessment
because
it
did
no
assess
for
reproductive
effects
or
possible
effects
on
aromatase.
870.3250
90
Day
dermal
toxicity
No
study.
No
study.
870.3465
90
Day
inhalation
toxicity
No
study.
No
study
Guideline
No./
Study
Type
MRID
No.
(
year)/
Classification
/
Doses
Results
12
870.3700a
Prenatal
developmental
in
rodents
00042543/(
1979)
Unacceptable/
Guideline
but
acceptable
with
other
studies
(
see
below).
0,
5,
13,
35
mg/
kg/
day
Maternal
NOAEL
>
35
mg/
kg/
day
(
HDT)
LOAEL
not
established
Developmental
NOEL
=
13
mg/
kg/
day
LOEL
=
35
mg/
kg/
day
based
on
hydronephrosis
(
this
effect
was
shown
to
be
reversible
and
is
not
considered
adverse).
Special
study
to
assess
for
reversibility
of
hydronephrosis.
00132988/(
1983)
Acceptable/
Non
Guideline.
0
and
35
mg/
kg/
day.
Maternal
NOAEL
=
not
established.
LOAEL
=
35
mg/
kg/
day
based
on
sporadic
dystocia.
Developmental
NOEL
<
35
mg/
kg/
day.
LOEL
=
35
mg/
kg/
day
based
on
kidney
effects
(
hydronephrosis,
this
effect
was
shown
to
be
reversible
and
is
not
considered
adverse)
Above
two
studies
combine
to
satisfy
the
guideline
requirement
for
a
developmental
toxicity
study
in
rats.
870.3700b
Prenatal
developmental
in
rabbits
44716001/
1990/
Acceptable/
Guideline
0,
15,
50
or
150
mg/
kg/
day.
Maternal
NOAEL
=
50
mg/
kg/
day
LOAEL
=
150
mg/
kg/
day
based
on
increased
abortions
and
decreased
body
weights
and
gain
and
food
consumption.
Developmental
NOAEL
=
>
150
mg/
kg/
day
870.3800
Reproduction
and
fertility
effects
00235175,
45502301
(
1977)
Unacceptable/
Not
upgradeable
0,
2.9,
7.9
or
20
mg/
kg/
day
in
males;
0,
3.4,
9
or
23.5
mg/
kg/
day
in
females.
Parental/
Systemic
NOAEL
>
23.5
mg/
kg/
day
(
HDT)
LOAEL
not
established
Reproductive
LOAEL
<
2.9
mg/
kg/
day
based
on
decreased
fertility
in
the
F1
generation
second
mating.
Offspring
NOAEL
and
LOAEL
could
not
be
established
due
to
anti
fertility
effects
in
the
parental
generations,
which
prevented
valid
assessment
of
the
pup
generations.
Second
study
00235175,
45502302
(
1978)
Acceptable/
Guideline
0,
0.6,
1.2,
2.5
mg/
kg/
day
in
males
and
0,
0.8,
1.7
or
3.2
mg/
kg/
day
in
females.
Parental/
Systemic
NOAEL
>
2.5
mg/
kg/
day
in
males
and
3.2
mg/
kg/
day
in
females
(
HDT)
LOAEL
not
established
Parental
Reproductive
NOAEL
=
0.6
mg/
kg/
day.
LOAEL
=
1.2
mg/
kg/
day
based
on
decreased
liveborn
litter
size
in
the
F1
and
F2
generations.
Offspring.
NOAEL
=
1.2
mg/
kg/
day.
LOAEL
=
2.5
mg/
kg/
day
based
on
decreased
survival
indices
and
possible
presence
of
hydronephrosis
Above
two
studies
combine
to
satisfy
the
guideline
requirement
for
a
multi
generation
reproduction
study
in
rats.
870.3800
Reproduction
and
fertility
effects
(
Special
Study)
00084968
Acceptable/
Non
Guideline
0,
35
mg/
kg/
day
LOAEL
for
males
and
females
>
35
mg/
kg/
d
(
males
decreased
mating
and
epididymal
weight,
females
dystocia
and
related
parameters)
NOAEL
not
established
870.4100a
Chronic
toxicity
rodents
See
combined
chronic
feeding
and
carcinogenicity
study.
Guideline
No./
Study
Type
MRID
No.
(
year)/
Classification
/
Doses
Results
13
870.4100b
Chronic
toxicity
dogs
00146959/
1985/
Acceptable/
Guideline
0,
1.25,
12.5
or
125
mg/
kg/
day.
NOAEL
=
12.5
mg/
kg/
day
LOAEL
=
125
mg/
kg/
day
based
on
reversible
increase
in
liver
weight
and
increase
in
alkaline
phosphatase.
870.4200
Combined
Chronic
Feeding
and
Carcinogenicity
rats
00235175/
1978/
Acceptable/
Guideline
0,2,
5.3,
or
14.6
mg/
kg/
day
for
male
and
0,
2.8,
7.6
or
21.55
mg/
kg/
day
for
females.
NOAEL
=
5.3
mg/
kg/
day.
LOAEL
=
14.6
mg/
kg/
day
based
on
hormonal
changes
(
prolactin
and
luteinizing
hormone)
and
possibly
fatty
liver
change
and
decreased
WBC
count
in
females.
870.4200
Combined
Chronic
Feeding
and
Carcinogenicity
rats
00153313/
1985/
Acceptable/
Guideline
0.5,
1,
2
mg/
kg/
day
for
males
and
0,
0.6,
1.2
or
2.3
mg/
kg/
day
for
females.
NOAEL
=
1
mg/
kg/
day
in
males
and
>
2.3
mg/
kg/
day
in
females.
LOAEL
=
2
mg/
kg/
day
in
males
based
on
minimal
gross
and
microscopic
changes
in
liver
and
possibly
testis.
There
was
no
evidence
of
carcinogenicity
or
increase
in
liver
tumors.
The
above
two
studies
combine
to
satisfy
the
guideline
requirement
for
carcinogenicity
testing
in
rats.
It
should
be
noted
that
the
potential
for
fenarimol
to
cause
decreased
fertility
and
dystocia
at
the
dose
levels
tested
in
the
rat
studies
contributed
to
the
weight
of
evidence
that
the
rat
was
assessed
at
adequate
dose
levels.
870.4300
Carcinogenicity
mice
0071920/
1978/
Acceptable/
Guideline
0,
7,
24
and
86
mg/
kg/
day
for
both
sexes.
NOAEL
=
>
86
mg/
kg/
day
(
HDT).
The
HIARC
and
CARC
concluded
that
there
was
no
evidence
of
carcinogenicity
although
liver
tumors
were
highest
in
the
high
dose
group
but
incidence
was
considered
too
low
to
be
meaningful.
Mutagenticity
870.
See
Table2.
a.
below.
870.6200a
Acute
neurotoxicity
screening
battery
No
study.
No
study.
Not
required.
870.6200b
Subchronic
neurotoxicity
screening
battery
No
study.
No
study.
Not
required.
870.6300
Developmental
neurotoxicity
Study
is
being
required
and
special
inclusions
to
assess
for
possible
effects
due
to
hormonal
disruption
required.
870.7485
Metabolism
and
pharmacokinetics
00261349
and
00261350
(
1985)
A
series
of
studies
with
radioactive
label
in
different
positions
established
that
fenarimol
is
readily
absorbed
and
excreted
with
the
biliary
route
being
most
important
in
rats
but
the
urinary
route
being
important
in
rabbits.
Metabolism
was
extensive
with
30
or
more
metabolites
noted.
Little
radioactivity
remained
in
the
tissue.
Guideline
No./
Study
Type
MRID
No.
(
year)/
Classification
/
Doses
Results
14
870.7600
Dermal
absorption
monkeys
00162538
(
1985)
Study
currently
under
review
The
range
of
dermal
absorption
factors
as
determined
by
the
Feldman
Maibach
model
(
2.8%),
area
under
the
curve
method
(
1.6%)
and
the
net
recovery
plus
unaccounted
for
material
(~
19%)
can
be
considered
in
a
weight
of
evidence
approach
to
estimate
a
dermal
absorption
factor
for
risk
assessment
purposes.
Special
studies
Several
special
studies
were
presented
to
investigate
the
mechanism
of
the
decreased
fertility
and
dystocia.
These
are
listed
above
in
this
table
under
the
heading
for
the
study
type
which
they
most
closely
resemble
(
i.
e.
reproduction
or
developmental)
Table
2.
a.
Mutagenticity/
Genotoxicity
Studies
Study
Results
Bacterial
mutagenicity
(
Ames
test)
Salmonella
typhimurium
and
Escherichia
coli.
Elanco,
1976.
MRID
No.:
243372
(
Acc.
No.:).
Not
mutagenic
with
and
without
metabolic
activation
at
doses
up
to
100
g/
plate.
Classification:
"
Minimum"
(
Acceptable)
Forward
mutation
assay
in
TK
±
mouse
lymphoma
assay.
Elanco,
August
1,
1979.
MRID
No.:
00042538
No
evidence
of
mutagenicity
when
tested
at
0,
3,
6,
12,
50
or
100
g/
mL.
The
100
g/
mL
dose
level
was
toxic.
Classification:
"
minimum"
(
acceptable).
DNA
repair
synthesis.
Elanco,
Study
No.:
790503
1,
June
1979.
MRID
No.:
00042541
No
evidence
of
induction
of
DNA
repair
at
dose
levels
of
0,
0.05,
0.1,
0.5,
10,
50
or
100
nanomoles/
mL
for
five
hours
incubation.
Cytotoxicity
resulted
at
50
and
100
nano
moles/
mL.
Classification:
"
minimum"
(
acceptable).
In
vivo
cytogenetics
in
hamsters.
Cabinet
d'Etudes
et
de
Recherches
en
Tox.
Study
No.:
658,
May
10,
1982.
MRID
No.:
00144051
Negative
for
mutagenic
effects
at
does
of
250
mg/
kg
(
times
2
doses)
in
bone
marrow
cells.
Classification:
Acceptable.
micronucleus
assay
mouse
Cabinet
d'Etudes
et
de
Recherches
en
Tox.
Study
No.:
650,
May
1,
1982.
MRID
No.:
00144050
Positive
for
clastogenic
effects
in
male
mice
at
1
gm/
kg
at
24
hours.
Assessments
at
48
and
72
hours
were
considered
confounded
since
there
were
no
positive
controls.
Classification:
UNACCEPTABLE
for
48
and
72
hours.
ACCEPTABLE
for
24
hours.
Evaluation
of
carcinogenicity
in
the
mouse
C3H/
10T
½
embryonic
mouse
fibroblast
culture
system.
Elanco,
August
1,
1980.
MRID
No.:
00046637.
No
malignant
transformations
were
observed
in
fenarimol
treated
cultures
between
4
and
256
nanomoles/
mL.
Classification:
"
minimum"
(
acceptable).
Dominant
lethal
rat.
Lilly,
Study
No.:
R
346
January,
1977
MRID
No.:
00042542
A
single
dose
of
350
mg/
kg
fenarimol
(
in
acacia
solution)
did
not
result
in
symptoms
of
toxicity
to
the
males
and
did
not
indicate
a
dominant
lethal
effect
when
the
rats
were
mated
4
days
after
treatment.
Classification:
"
minimum"
(
acceptable).
Study
Results
15
Armoatase
inhibition
assay
in
stimulated
rat
ovarian
microsomal
system.
Elanco,
January
1,
1982.
MRID
No.:
00093876
Fenarimol
is
a
moderately
weak
inhibitor
of
aromatase
activity
in
the
stimulated
rat
ovarian
microsomal
system
Classification:
Supplementary.
3.2
FQPA
Considerations
The
FQPA
Safety
Factor
committee
addressed
the
potential
enhanced
sensitivity
of
infants
and
children
from
exposure
to
fenarimol
as
required
by
the
FQPA
of
1996.
HIARC
examined
the
prenatal
developmental
toxicity
studies
in
rats
and
rabbits
and
the
two
generation
reproduction
study
in
rats,
and
concluded
that
the
database
does
not
show
evidence
of
increased
susceptibility
to
fetuses
and
young
(
HIARC,
9/
5/
01).
The
HIARC
determined
that
a
developmental
neurotoxicity
study
should
be
required
based
on
the
need
to
determine
if
the
potential
hormonal
effects
as
elicited
by
inhibition
of
aromatase
will
result
in
effects
in
the
rat
pups.
Thus
the
FQPA
Safety
Factor
Committee
(
B.
Tarplee,
9/
28/
01)
recommended
that
the
10x
Safety
Factor
should
be
retained
at
10x
for
fenarimol
due
to
the
following
data
gaps:
a
developmental
neurotoxicity
study
with
fenarimol
is
required
to
determine
if
the
potential
hormonal
effects
elicited
by
inhibition
of
aromatase
will
result
in
effects
in
the
rat
pups;
and
the
environmental
fate
database
is
incomplete
for
the
aquatic
photolytic
degradate
of
fenarimol,
4
chloro
2(
5
pyrimidyl)
2'
chlorobenzophenone.
A
screening
level
drinking
water
assessment
which
includes
this
degradate
of
concern
is
not
possible
at
this
time
because
of
a
lack
of
data.
The
FQPA
committee
determined
that
the
10x
FQPA
factor
should
be
retained
for
all
populations
and
all
fenarimol
risk
assessments.
3.3
Dose
Response
Assessment
and
Hazard
Endpoint
Selection
The
strengths
and
weaknesses
of
the
fenarimol
toxicology
database
were
considered
during
the
process
of
toxicity
endpoint
and
dose
selection.
In
general,
most
of
the
required
guideline
studies
on
fenarimol
were
available
and
provided
reasonable
confidence
when
the
toxicity
endpoints
and
doses
for
risk
assessment
were
selected.
Based
on
the
evaluation
of
the
above
summarized
studies,
the
Hazard
Identification
Assessment
Review
Committee
(
HIARC)
identified
the
toxicity
endpoints
and
the
dose
levels
for
use
in
risk
assessment
(
HIARC
document
of
9/
5/
01).
The
selected
toxicity
endpoints
are
summarized
in
Table
3.
The
METARC
recommended
(
J.
Doherty,
9/
17/
01),
and
the
HIARC
confirmed,
that
the
reduced
male
fertility
and
dystocia
effects
of
fenarimol
should
be
endpoints
for
human
health
risk
assessment.
It
is
noted
that
the
endpoint
from
the
multi
generation
reproduction
study
is
based
on
decreased
litter
size.
This
decrease
in
litter
size
may
be
a
reflection
of
the
maternal
toxicity
or
the
potential
for
fenarimol
to
inhibit
aromatase.
In
this
regard,
it
is
a
meaningful
endpoint
for
all
populations,
males
and
females.
Consequently,
HED
identified
a
reference
dose
for
chronic
exposure
(
cRfD)
of
0.006
mg/
kg/
day
from
the
multi
generation
reproduction
study
based
on
a
no
observed
adverse
effect
level
(
NOAEL)
of
0.6
16
mg/
kg/
day,
and
a
10X
uncertainty
factor
for
interspecies
extrapolation
and
a
10X
uncertainty
factor
for
intraspecies
variation.
The
NOAEL
of
0.6
mg/
kg/
day
is
based
on
decreased
live
born
litter
size
in
the
F
1
and
F
2
generations
at
a
lowest
observed
adverse
effect
level
(
LOAEL)
of
1.2
mg/
kg/
day.
HED
calculated
a
chronic
Population
Adjusted
Dose
(
cPAD)
of
0.0006
mg/
kg/
day.
The
cPAD
is
the
RfD
divided
by
the
FQPA
safety
factor
(
10X).
Chronic
dietary
exposure
estimates
greater
than
100%
of
the
cPAD
would
exceed
HED's
level
of
concern.
The
endpoint
and
dose
was
also
used
for
the
intermediate
term
(
1
6
months)
incidental
oral,
dermal,
and
inhalation
risk
assessments.
A
Margin
of
Exposure
or
MOE,
which
is
the
ratio
of
the
NOAEL
to
the
exposure
estimate,
of
greater
than
1000
does
not
exceed
HED's
level
of
concern
for
these
risk
assessments.
An
MOE
of
greater
than
1000
is
required
because
of
the
10x
interspecies
factor,
the
10x
intraspecies
factor
and
the
10x
FQPA
factor.
For
the
short
term
(
1
30
day)
incidental
oral,
dermal,
and
inhalation
risk
assessments,
a
LOAEL
of
35
mg/
kg/
day
was
selected.
This
endpoint
is
based
on
decreased
fertility
and
dystocia,
an
indicator
of
hormonal
effects,
observed
in
a
special
non
guideline
cross
breeding
reproduction/
developmental
toxicity
study
in
rats.
Because
a
LOAEL
is
used
an
additional
3x
uncertainty
factor
was
applied.
Therefore,
a
MOE
greater
than
3000
does
not
exceed
HED's
level
of
concern
for
short
term
risk
assessments.
An
acute
dietary
toxicity
endpoint
was
not
identified
by
HIARC,
and
consequently,
no
acute
risk
assessment
was
required.
17
Table
3.
Summary
of
Toxicity
Endpoints
and
Doses
for
Risk
Assessment.
EXPOSURE
SCENARIO
DOSE
(
mg/
kg/
day)
ENDPOINT
STUDY
Acute
Dietary
No
appropriate
study
for
a
single
dose
risk
assessment.
Chronic
Dietary
NOAEL
=
0.6
UF
=
100X
FQPA
=
10X
Decreased
liveborn
litter
size
in
rat
reproduction
study.
LOAEL
=
1.2
mg/
kg/
day
Rat
reproduction
MRID
#
00235175
Chronic
RfD
=
0.006
mg/
kg/
day
Chronic
PAD
=
0.0006
mg/
kg/
day
Incidental
Oral,
Short
Term
LOAEL=
35
UF
=
300X
FQPA
=
10X
Decreased
fertility
and
dystocia
an
indication
of
hormonal
effects.
Special
reproduction
study
MRID
#
0084968
Incidental
Oral,
Intermediate
Term
NOAEL=
0.6
UF
=
100X
FQPA
=
10X
Decreased
liveborn
litter
size.
LOAEL
=
1.2
mg/
kg/
day
Rat
reproduction
MRID
#
00235175
Dermal,
Short
Term
Oral
LOAEL=
35
UF
=
300X
FQPA
=
10X
Decreased
fertility
and
dystocia
an
indication
of
hormonal
effects.
Special
reproduction
study
MRID
#
0084968
Dermal,
Intermediate
Term
Oral
NOAEL=
0.6
UF
=
100X
FQPA
=
10X
Decreased
liveborn
litter
size.
LOAEL
=
1.2
mg/
kg/
day
Rat
reproduction
MRID
#
00235175
Dermal,
Long
Term
Oral
NOAEL=
0.6
UF
=
100X
FQPA
=
10X
Decreased
liveborn
litter
size.
LOAEL
=
1.2
mg/
kg/
day
Rat
reproduction
MRID
#
00235175
Inhalation,
Short
Term
Oral
NOAEL
=
35
UF
=
100X
FQPA
=
10X
Decreased
fertility
and
dystocia
an
indication
of
hormonal
effects
Special
reproduction
study
MRID
#
0084968
Inhalation,
Intermediate
Term
Oral
NOAEL=
0.6
UF
=
100X
FQPA
=
10X
Decreased
liveborn
litter
size.
LOAEL
=
1.2
mg/
kg/
day
Rat
reproduction
MRID
#
00235175
Inhalation,
Long
Term
Oral
NOAEL=
0.6
UF
=
100X
FQPA
=
10X
Decreased
liveborn
litter
size.
LOAEL
=
1.2
mg/
kg/
day
Rat
reproduction
MRID
#
00235175
Because
a
toxicity
endpoint
from
an
oral
study
was
selected
for
dermal
and
inhalation
endpoints,
a
dermal
absorption
factor
of
20%
must
be
used
for
oral
to
dermal
route
to
route
exposures
and
a
100%
inhalation
absorption
factor
must
be
used
for
inhalation
exposures.
3.4
Endocrine
Disruption
The
Agency
is
required
under
the
FFDCA,
as
amended
by
FQPA,
to
develop
a
screening
program
to
determine
whether
certain
substances
(
including
all
pesticide
active
and
other
ingredients)
"
may
have
an
effect
in
humans
that
is
similar
to
an
effect
produced
by
a
naturally
occurring
estrogen,
or
other
such
endocrine
effects
as
the
Administrator
may
designate."
Following
the
recommendations
of
its
Endocrine
Disruptor
Screening
and
Testing
Advisory
Committee
(
EDSTAC),
EPA
determined
that
there
was
scientific
bases
for
including,
as
part
of
the
program,
the
androgen
and
thyroid
hormone
systems,
in
addition
to
the
estrogen
hormone
system.
EPA
also
adopted
EDSTAC's
recommendation
18
that
the
Program
include
evaluations
of
potential
effects
in
wildlife.
For
pesticide
chemicals,
EPA
will
use
FIFRA
and,
to
the
extent
that
effects
in
wildlife
may
help
determine
whether
a
substance
may
have
an
effect
in
humans,
FFDCA
authority
to
require
the
wildlife
evaluations.
As
the
science
develops
and
resources
allow,
screening
of
additional
hormone
systems
may
be
added
to
the
Endocrine
Disruptor
Screening
Program
(
EDSP).
Fenarimol
has
demonstrated
effects
on
hormonal
systems.
When
the
appropriate
screening
and/
or
testing
protocols
being
considered
under
the
Agency's
EDSP
have
been
developed,
fenarimol
may
be
subjected
to
additional
screening
and/
or
testing
to
better
characterize
effects
related
to
endocrine
disruption.
4.0
EXPOSURE
ASSESSMENT
4.1
Summary
of
Registered
Uses
Fenarimol
is
currently
registered
for
use
on
fruit
and
nut
crops
such
as
apples,
cherries,
filberts,
grapes,
pears,
and
pecans
as
well
as
on
ornamental
plants,
trees,
and
grasses
and
turf
lawns.
Fenarimol
is
also
used
on
imported
bananas.
The
registration
of
fenarimol
is
being
supported
by
Dow
AgroSciences
LLC.
The
sole
fenarimol
formulation
class
which
is
registered
for
use
on
fruit
and
nut
crops
is
an
emulsifiable
concentrate
sold
under
the
trade
name
RubiganJ,
and
this
formulation
is
typically
applied
using
ground
equipment.
It
is
also
registered
for
use
on
ornamental
plants,
trees,
and
grasses
and
turf
lawns
4.2
Dietary
Exposure
and
Risk
Assessment
4.2.1
Residue
Profile
The
established
permanent
and
time
limited
tolerances
for
fenarimol
are
published
in
40
CFR
§
180.421
and
are
expressed
in
two
different
ways.
Tolerances
listed
under
40
CFR
§
180.421(
a)(
1)
and
§
180.421(
b)
are
expressed
in
terms
of
residues
of
fenarimol
per
se.
Tolerances
listed
under
40
CFR
§
180.421(
a)(
2)
are
expressed
in
terms
of
the
combined
residues
of
fenarimol
and
its
metabolites
[
alpha(
2
chlorophenyl)
alpha(
4
chlorophenyl)
1,4
dihydro
5
pyrimidinemethanol(
Metabolite
B)
and
5[
2
chlorophenyl)(
4
chlorophenyl)
methyl]
3,4
dihydro
4
pyrimidinol]
(
Metabolite
C)
measured
as
the
total
of
fenarimol
and
5[
2
chlorophenyl)(
4
chlorophenyl)
methyl]
pyrimidine
(
calculated
as
fenarimol).
The
registration
requirements
for
plant
metabolism
are
fulfilled.
Acceptable
studies
depicting
the
metabolism
of
[
14C]
fenarimol
in
apples,
cherries,
and
grapes
are
available.
The
apple
and
cherry
metabolism
studies
indicate
that
the
parent
fenarimol
is
the
major
residue
component
whereas
the
grape
metabolism
study
identified
the
parent
plus
Metabolites
B
and
C
as
the
principal
residue
components.
The
Metabolism
Assessment
Review
Committee
(
MARC)
has
determined
that
for
enforcement
purposes,
the
tolerance
should
be
expressed
as
parent
only.
However,
the
dietary
assessment
for
grapes
and
bananas
should
include
the
Metabolites
B
and
C,
because
of
their
structural
similarity
to
parent
fenarimol
and
because
there
are
existing
residue
data
for
the
metabolites
on
those
commodities
(
D277692,
9/
17/
01,
D.
Drew).
Combined
residues
of
Metabolites
B
and
C
occur
on
banana
pulp
samples
at
a
range
of
0.24x
to
1.7x
that
of
parent
fenarimol,
and
on
grapes
at
a
range
of
0.59x
to
3.3x
that
of
parent
fenarimol.
Analytical
methods
exist
for
determining
residues
of
Metabolites
B
and
C
(
measured
as
deshydroxyfenarimol)
in
plants.
The
chemical
names
and
structures
of
fenarimol
and
Metabolites
B
and
C
are
depicted
below
in
Figure
1.
19
N
N
OH
Cl
Cl
NH
N
OH
Cl
Cl
N
NH
Cl
Cl
OH
Figure
1.
Chemical
Names
and
Structures
of
Fenarimol
and
Metabolites
B
and
C.
Common
Name
Chemical
Structure
Chemical
Name
Common
Name
Chemical
Structure
Chemical
Name
Common
Name
Chemical
Structure
Chemical
Name
Fenarimol
Metabolite
B
(
Compound
212746)
Metabolite
C
(
Compound
210302)
[
alpha(
2
chlorophenyl)
alpha(
4
chlorophenyl)
5
pyrimidinemethanol]
[
alpha(
2
chlorophenyl)
alpha(
4
chlorophenyl)
1,4
dihydro
5
pyrimidinemethanol]
[
5[
2
chlorophenyl)(
4
chlorophenyl
methyl]
3,4
dihydro
4
pyrimidinol]
The
qualitative
nature
of
the
residue
in
milk
and
ruminant
tissues
is
adequately
understood.
For
the
purpose
of
registration,
the
terminal
residue
of
concern
in
milk
and
ruminant
and
hog
tissues
is
fenarimol
per
se.
Wet
apple
pomace
is
the
only
animal
feed
item
associated
with
the
registered
uses
of
fenarimol.
There
are
no
hog
or
poultry
feed
items.
The
registration
requirements
for
residue
analytical
methods
are
fulfilled.
Adequate
methods
are
available
for
data
collection
and
enforcement
of
tolerances
for
residues
of
fenarimol
per
se
in/
on
plants
and
livestock.
Adequate
methods
are
also
available
for
determination
of
residues
of
fenarimol
and
Metabolites
B
and
C
in
plants
[
Pesticide
Analytical
Manual
(
PAM)
Volume
II,
Methods
I
(
AMAA
CA
R039
AB
755),
II
(
AM
AA
CA
R072
AA
755),
and
III
(
AM
AA
CA
R124
AA
755].
The
requirements
for
data
depicting
magnitude
of
the
residue
in/
on
plants
are
fulfilled
for
the
following
raw
agricultural
commodities
(
RACs):
apples,
cherries,
filberts,
grapes,
pears,
and
imported
bananas.
Overall,
a
sufficient
number
of
field
trials
were
conducted,
and
the
trials
were
conducted
using
representative
fenarimol
formulations
at
the
maximum
registered
application
rates.
In
some
cases,
residue
data
were
translated
from
closely
related
plant
groups
with
identical
use
patterns.
Adequate
processing
data
are
also
available.
Studies
indicate
that
fenarimol
per
se
concentrate
in
wet
apple
pomace
(
3.7x)
but
not
in
apple
juice
(
0.05x).
Grape
processing
studies
indicate
that
the
combined
residues
of
fenarimol
and
its
metabolites
concentrate
in
grape
juice
(
1.6x)
and
raisins
(
1.2x).
The
concentration
factors
for
grape
products
are
of
such
small
magnitude
that
tolerances
will
not
have
to
be
established
for
grape
juice
or
raisins.
4.2.2
Dietary
Exposure
Risk
from
Food
Sources
HED
conducts
dietary
risk
assessments
using
the
Dietary
Exposure
Evaluation
Model
(
DEEMJ
Version
7.075),
which
incorporates
consumption
data
generated
in
USDA's
Continuing
Surveys
of
Food
Intakes
by
Individuals
(
CSFII),
1989
1992.
For
chronic
dietary
risk
assessments,
the
three
day
average
of
consumption
for
each
sub
population
is
combined
with
average
residues
in
commodities
to
20
determine
average
exposures
in
mg/
kg/
day.
The
chronic
dietary
exposure
assessment
for
fenarimol
is
highly
refined
using
anticipated
residues
based
on
1996
1999
Food
and
Drug
Administration
(
FDA)
monitoring
data
for
apples,
bananas,
cherries,
grapes
and
pears.
Field
trial
residue
data
were
used
for
pecans
and
filberts.
Percent
crop
treated
(%
CT)
information
and
processing
factors,
where
available,
were
used
in
the
assessment.
here
were
no
PDP
monitoring
data
available
for
fenarimol.
Residues
of
fenarimol
per
se
were
nondetectable
(
below
the
method
limit
of
detection,
or
LOD)
in
all
1996
1999
FDA
monitoring
samples
of
apples,
bananas,
grapes,
and
pears
(
a
total
of
more
than
3,000
samples).
Out
of
214
cherry
samples,
three
had
detectable
residues.
Residues
of
fenarimol
per
se
were
nondetectable
(<
LOD)
in/
on
all
but
one
pecan
nut
meat
sample
from
seven
trials.
There
were
no
detectable
residues
in
filbert
samples
from
four
field
trials.
FDA
results
for
bananas
and
grapes
were
adjusted
to
account
for
potential
residues
of
Metabolites
B
and
C.
Banana
and
grape
field
trial
data
indicate
that
total
metabolites
of
fenarimol
occur
in
banana
pulp
at
a
maximum
2X
of
fenarimol
per
se,
and
in
grape
at
a
maximum
of
3x.
The
anticipated
secondary
residues
of
fenarimol
in
ruminant
tissues
(
meat,
fat
and
meat
byproducts)
are
derived
from
a
cattle
feeding
study
(
MRID
40098605,
PP#
4F3108,
F.
Boyd,
9/
20/
84).
Wet
apple
pomace
is
the
only
feedstuff
associated
with
registered
uses
of
fenarimol.
Anticipated
residues
were
all
very
low
(
all
less
than
0.003
ppm).
Milk,
eggs,
poultry
tissue
and
hog
tissue
were
not
included
in
the
dietary
assessment
because
the
Agency
has
determined
that
there
is
no
reasonable
expectation
of
finite
residues
of
fenarimol
in
these
animal
commodities,
and
is
recommending
that
established
tolerances
for
milk,
hog
tissues,
poultry
tissues,
and
eggs
be
revoked
as
per
Category
3
of
40
CFR
§
180.6(
a).
There
are
no
poultry
or
hog
feed
items
associated
with
the
registered
uses
of
fenarimol.
This
assessment
concludes
that
for
all
supported
registered
commodities,
the
chronic
risk
estimates
are
below
the
Agency's
level
of
concern
(<
100%
of
the
chronic
population
adjusted
dose,
cPAD)
for
the
general
U.
S.
population
and
all
population
subgroups
(<
1%
of
the
cPAD).
Table
4.
Results
of
Chronic
Dietary
Exposure
Analysis
Population
Subgroup
Exposure
(
mg/
kg/
day)
%
cPAD1
U.
S.
Population
(
total)
0.000000
<
1
All
Infants
(<
1
year)
0.000001
<
1
Children
1
6
years
0.000002
<
1
Children
7
12
years
0.000001
<
1
Females
13
50
0.000000
<
1
Males
13
19
0.000000
<
1
Males
20+
years
0.000000
<
1
Seniors
55+
0.000000
<
1
1
cPAD
=
0.0006
mg/
kg/
day
21
4.3
Water
Exposure
Pathway
This
assessment
is
based
on
environmental
fate
studies
conducted
in
the
1970s
and
early
1980s.
The
quality
of
the
data
provided
by
these
studies
is
significantly
lower
than
currently
required.
By
current
standards
most
of
these
studies
would
not
be
considered
acceptable
and
the
results
would
not
be
considered
of
sufficient
quality
to
allow
a
reasonably
accurate
assessment
of
the
environmental
fate
of
this
compound.
Fenarimol
is
persistent
and
moderately
mobile
in
the
environment.
In
field
studies,
fenarimol
reportedly
dissipated
with
half
lives
of
3
months
to
several
years
from
soil
and
turf
surfaces
and
much
slower
when
incorporated
into
soil.
Based
on
fenarimol's
chemical
properties
it
is
likely
that
this
chemical
will
move
to
surface
water
and
groundwater,
and
it
may
accumulate
in
the
environment.
It
is
believed
to
be
stable
to
hydrolysis,
anaerobic
microbial
degradation
and
photolysis
on
soil.
It
is
degraded
very
slowly,
if
at
all,
by
aerobic
microbial
processes
with
reported
mean
aerobic
soil
metabolism
half
life
of
about
4
years.
It
is
degraded
by
photolysis
in
aqueous
solution.
The
primary
photolysis
product
is
4
chloro
2(
5
pyrimidyl)
2'
clorobenzophenone.
The
MARC
elected
not
to
exclude
this
aquatic
photolysis
degradate
in
the
drinking
water
exposure
assessment
because:
1)
its
potential
to
occur
in
surface
water;
and,
2)
the
lack
of
data
to
determine
whether
or
not
it
is
of
toxicological
concern.
Tier
I
surface
water
and
groundwater
Estimated
Environmental
Concentrations
(
EECs)
for
fenarimol
were
calculated
using
FIRST
(
surface
water)
and
SCI
GROW
(
groundwater)
modeling
of
application
to
turf.
FIRST
is
a
first
tier
screening
model
designed
as
a
coarse
screen
to
estimate
the
pesticide
concentrations
found
in
an
`
Index
Reservoir'
located
in
Shipman,
Illinois
for
use
in
environmental
risk
assessments
for
drinking
water.
As
such,
it
provides
high
end
estimates
of
the
concentrations
of
a
pesticide
in
drinking
water
that
might
be
derived
from
surface
water.
This
first
level
tier
is
designed
as
a
coarse
screen
and
estimates
concentrations
from
only
a
few
basic
chemical
parameters
and
pesticide
label
application
information.
The
FIRST
program
is
designed
to
mimic
a
more
complex
simulation
such
as
using
the
linked
PRZM
and
EXAMS
models,
but
requires
less
time
and
effort
to
complete.
If
a
risk
assessment
performed
using
FIRST
output
does
not
exceed
the
level
of
concern,
then
one
can
be
reasonably
confident
that
the
acute
risk
will
not
be
exceeded.
However,
for
stable
chemicals
with
long
environmental
half
lives
FIRST
may
significantly
underestimate
long
term
EECs.
SCI
GROW
provides
a
groundwater
screening
exposure
value
to
be
used
in
determining
the
potential
risk
to
human
health
from
drinking
water
contaminated
with
the
pesticide.
SCI
GROW
estimates
EEC
values
in
shallow
groundwater
for
only
a
single
season
and
so
is
much
less
useful
in
estimating
EEC
values
for
stable
compounds
that
may
persist
in
the
environment.
The
EEC
value
calculated
using
SCI
GROW
should
therefore
be
used
with
caution
since
it
probably
underestimates
possible
groundwater
concentrations.
EECs
for
surface
and
ground
water
are
summarized
in
Table
5.
The
surface
water
acute
EEC
is
242
ppb.
The
surface
water
chronic
EEC
is
59
ppb.
These
values
represent
the
maximum
surface
water
concentration,
and
the
mean
yearly
concentration,
respectively,
resulting
from
fenarimol
use
on
turf.
The
groundwater
screening
concentration
calculated
using
SCI
GROW
is
14
ppb
and
represents
a
90
day
average
concentration
value.
This
value
should
be
used
for
both
chronic
and
acute
groundwater
estimates.
It
is
not
possible
to
identify
possible
degradates
of
concern
at
this
time.
Table
5.
Modeling
Results
(
Estimated
Environmental
Concentrations
(
EECs))
for
Application
22
of
Fenarimol
to
Turf.
Model
Concentrationa
FIRST
Peak
Day
(
Acute)
Surface
Water
242
ppb
FIRST
Annual
Average
(
Chronic)
Surface
Water
59
ppb
SCIGROW
Ground
Water
Value
14
ppb
a
EECs
are
for
parent
fenarimol
only
and
do
not
include
aqueous
photolytic
degradate.
4.4
Residential
Exposure
Potential
residential
exposures
may
occur
as
a
result
of
applications
of
fenarimol
to
residential
lawns
or
turf
by
residents
and
by
professional
lawn
care
operators
(
LCOs).
Residential
exposures
have
been
estimated
based
on
label
application
frequency,
and
the
persistence
of
fenarimol.
Most
assumptions
for
risk
estimation
were
based
on
the
Residential
SOPs.
Chemical
specific
data
from
a
turf
transferable
residue
(
TTR)
study
were
available
and
were
used
to
estimate
the
dissipation
of
fenarimol.
As
a
result
of
home
lawn
uses,
the
HED
has
concerns
for
potential
exposures
to
both
adults
and
children.
Application
and
subsequent
exposure
in
residential
settings
for
the
use
sites
other
than
turf
(
i.
e.
ornamentals,
roses,
grapes,
apples,
pears,
cherries,
and
pecans)
is
considered
unlikely.
Dow
AgroSciences
has
asserted
to
HED
that
product
for
these
use
sites
is
intended
for
and
used
only
in
commercial
operations.
Product
packaging
and
label
language
suggest
that
applications
in
residential
settings
would
not
occur.
Label
language
restrictions
include
equipment
requirements
such
as
personal
protective
equipment
(
PPE)
requirements,
worker
protection
standard
(
WPS)
requirements,
restrictions
for
use
by
PCOs,
and
application
methods
that
would
never
occur
in
residential
settings.
4.4.1
Home
Uses
4.4.1.1
Handler
Exposure
The
following
use
patterns
have
been
assessed
for
non
occupational
(
residential)
handler
exposures:
1)
granular
application
to
turf
with
a
belly
grinder
spreader;
2)
granular
application
to
turf
with
a
push
type
spreader;
and
3)
granular
spot
treatment
application
by
hand.
Short
term
dermal
and
inhalation
exposures
to
adults
are
likely
from
residents
handling
(
i.
e.
mixing,
loading
and
applying)
granular
product
to
lawns.
As
stated
above,
fenarimol
can
be
applied
to
residential
turf
by
residents
or
LCOs,
either
once
at
the
maximum
application
rate
(
2.73
lb
ai/
acre)
or
twice
as
a
split
application
of
half
the
maximum
rate
per
application.
Additionally,
fenarimol
could
be
applied
to
residential
turf
by
LCOs
as
many
as
12
times
per
season
at
significantly
lower
rates;
i.
e.
0.51
lb
ai/
acre
per
application.
However,
the
registrants
have
stated
that
only
one
to
two
applications
per
season
to
turf
are
anticipated,
since
users
rotate
between
different
systemic
and
contact
fungicides.
To
estimate
aggregate
risks,
the
short
term
dermal
risk
estimates
from
handler
exposures
and
dermal
risk
estimates
from
post
application
exposures
(
post
application
inhalation
exposures
are
not
anticipated)
can
be
combined.
Additionally,
short
term
dermal
and
inhalation
risk
estimates
from
handler
exposures
were
combined.
Table
10
details
the
exposure
and
risk
estimates
for
residents
handling
fenarimol.
Data
confidence
levels
are
described
in
Table
13.
For
short
term
(
1
30
days)
non
occupational
risk
assessments,
HED
has
established
a
level
of
concern
for
MOEs
less
than
3000.
Estimated
risks
to
residential
handlers
23
from
short
term
dermal
exposures
exceed
HED's
level
of
concern
for
the
scenarios
involving
broadcast
application
to
lawns
by
loading/
applying
the
granular
formulation
with
a
belly
grinder
(
MOE
=
69)
and
by
hand
dispersal
for
spot
treatments
(
MOE
=
390).
The
risk
estimate
from
dermal
exposures
did
not
exceed
the
level
of
concern
for
residents
applying
fenarimol
granular
formulations
via
a
push
type
spreader
(
MOE
=
11,000).
Additionally,
handler
risk
estimates
from
short
term
inhalation
exposures
did
not
exceed
the
level
of
concern
for
residents
applying
fenarimol
granular
formulations
with
a
belly
grinder
(
MOE
=
25,000),
a
push
type
spreader
(
MOE
=
1,700,000),
or
by
hand
dispersal
spot
treatments
(
MOE
=
71,000).
The
combined
short
term
dermal
and
inhalation
risk
estimates
were
the
same
as
those
computed
for
the
dermal
exposures;
i.
e.
for
belly
grinder
(
MOE
=
69),
hand
dispersal
(
MOE
=
390),
and
push
type
spreader
(
MOE
=
11,000),
because
estimated
inhalation
exposures
are
much
less
than
the
estimated
dermal
exposures
for
homeowner
pesticide
handlers.
4.4.1.2
Postapplication
Exposure
Several
post
application
exposure
scenarios
following
application
to
turf
are
anticipated;
these
are
as
follows:
1)
short
and
intermediate
term
dermal
exposure
to
adults
and
children
(
toddlers,
1
6
years
old);
2)
short
term
incidental
episodic
oral
exposure
to
children
from
ingestion
of
fenarimol
granules;
and
3)
short
and
intermediate
term
oral
exposure
to
children
from
incidental
ingestion
of
soil,
turf
grass
mouthing,
and
hand
to
mouth
activity.
Postapplication
dermal
and
inhalation
exposure
and
risk
estimates
are
presented
in
detail
in
Tables
11
and
12.
For
post
application
residential
exposures,
the
scenarios
with
risks
estimates
that
exceed
HED's
level
of
concern
(
short
term
(
ST)
MOEs
<
3000;
intermediate
term
(
IT)
MOEs
<
1000)
are
as
follows:
1)
the
high
contact
ST
&
IT
dermal
exposure
activities
(
adults
&
toddlers)
of
playing
or
working
on
lawns;
2)
the
ST
&
IT
incidental
oral
exposure
activity
by
toddlers
of
hand
to
mouth
while
playing
on
treated
lawns;
and
3)
the
ST
incidental
episodic
oral
exposure
activity
by
toddlers
of
ingesting
fenarimol
granules
while
playing
on
treated
lawns
[
Note:
HED
considers
this
risk
unlikely
given
the
smaller
particle
size
of
fenarimol
granules
and
the
fact
that
watering
in
likely
occurs
immediately
or
soon
after
application,
in
order
for
the
pesticide
to
be
efficacious.].
However,
for
post
application
residential
exposures,
the
scenarios
with
risks
estimates
that
do
not
exceed
HED's
level
of
concern
(
ST
MOEs
3000;
IT
MOEs
1000)
are
as
follows:
1)
the
low
contact
ST
&
IT
dermal
exposure
activities
of
mowing
lawns
and
golfing
on
treated
turf;
and
2)
the
ST
&
IT
incidental
oral
exposure
activity
by
toddlers
of
ingesting
soil
while
playing
on
treated
lawns.
Combining
risk
estimates
for
exposure
scenarios
that
are
likely
to
occur
together
resulted
in
risk
estimates
of
greater
concern.
For
example,
it
is
possible
that
the
same
individual
could
apply
granular
fenarimol
product
to
a
residential
lawn
and
immediately
afterwards
perform
high
contact
activities
on
that
lawn.
Combining
the
risk
estimates
for
the
residential
handler
using
a
belly
grinder
spreader
and
the
high
contact
post
application
activities
on
a
lawn
resulted
in
an
MOE
that
exceeds
HED's
level
of
concern
(
MOE
=
63).
Combining
the
post
application
turf
short
term
risk
estimates
for
the
incidental
oral
non
dietary
exposures
to
small
children
(
except
episodic
ingestion
of
fenarimol
granules)
resulted
in
a
risk
estimate
(
MOE
=
690)
that
exceeds
HED's
level
of
concern
(
MOE
<
3000).
Also,
combining
the
post
application
turf
intermediate
term
risk
estimates
for
incidental
oral
non
dietary
exposures
to
small
children
(
except
episodic
ingestion
of
fenarimol
granules)
resulted
in
a
risk
estimate
(
MOE
=
62)
that
exceeds
HED's
level
of
concern
(
MOE
<
1000).
Additionally,
combining
the
post
application
turf
dermal
and
incidental
oral
risk
estimates
for
small
children
(
except
episodic
ingestion
of
fenarimol
granules)
resulted
in
MOEs
(
short
term
MOE
=
140;
intermediate
term
MOE
=
50)
that
exceed
HED's
levels
of
concern
(
MOEs
<
3000
&
1000,
respectively).
24
Summary
of
Risk
Estimates
HED
calculates
risk
estimates
and
expresses
them
as
Margins
of
Exposure
(
MOEs).
For
fenarimol,
MOEs
that
are
less
than
3000
exceed
HED's
level
of
concern
for
short
term
(
ST)
exposures,
and
MOEs
less
than
1000
exceed
HED's
level
of
concern
for
intermediate
term
(
IT)
exposures.
Therefore,
the
target
MOEs
for
non
occupational
ST
and
IT
exposures
to
fenarimol
are
3000
and
1000,
respectively.
Exposure
scenarios
and
their
associated
risk
estimates
are
summarized
in
Table
6.
Risk
estimates
exceeding
HED's
level
of
concern
have
been
bolded
in
the
table.
Tables
10
13
in
Appendix
1
present
a
more
detailed
description
of
the
results
summarized
in
Table
6.
Table
6.
Summary
of
Exposure
Scenarios
and
Risk
Estimates
Exposure
Scenario
Route
of
Exposure
Population
ST
MOEa
IT
MOEb
Residential
Handlers
(
Mixers/
Loaders/
Applicators)
Exposures
Applying
Granular
Product
by
Hand
Application
Dermal
Adult
390
N/
A
Loading/
Applying
Granular
for
Belly
Grinder
Application
Dermal
Adult
69
N/
A
Loading/
Applying
Granular
for
Push
type
Spreader
Application
Dermal
Adult
11,000
N/
A
Applying
Granular
Product
by
Hand
Application
Inhalation
Adult
71,000
N/
A
Loading/
Applying
Granular
for
Belly
Grinder
Application
Inhalation
Adult
25,000
N/
A
Loading/
Applying
Granular
for
Push
type
Spreader
Application
Inhalation
Adult
1.7E+
6
N/
A
Combined
Residential
Handlers
Exposures
Applying
Granular
Product
by
Hand
Application
Dermal
&
Inhalation
Adult
390
N/
A
Loading/
Applying
Granular
for
Belly
Grinder
Application
Dermal
&
Inhalation
Adult
69
N/
A
Loading/
Applying
Granular
for
Push
type
Spreader
Application
Dermal
&
Inhalation
Adult
11,000
N/
A
Post
application
Exposures
High
Contact
Activities
e.
g.
Working
Dermal
Adult
240
360
High
Contact
Activities
e.
g.
Playing
Dermal
Toddler
170
250
Low
Contact
Activity
Mowing
Dermal
Adult
6800
5200
Low
Contact
Activity
Golfing
Dermal
Adult
3400
2600
Hand
to
Mouth
Activity
Oral
Toddler
860
78
Incidental
Turf
grass
Mouthing
Oral
Toddler
3400
320
Incidental
Ingestion
of
Soil
Oral
Toddler
2.6E+
5
2.4E+
4
Ingestion
of
Fenarimol
Product
Granules
Oral
Toddler
220
N/
A
Exposure
Scenario
Route
of
Exposure
Population
ST
MOEa
IT
MOEb
25
Combined
Post
application
Exposures
All
Incidental
Oral
Non
Dietary
(
except
granular
ingestion)
Oral
Toddler
690
62
Dermal
&
All
Incidental
Oral
Non
Dietary
(
except
granular
ingestion)
Oral
&
Dermal
Toddler
140
50
Residential
Handler
(
Belly
Grinder
Spreader)
&
High
Contact
Post
Application
Activities
Dermal
Adult
53
N/
A
a
ST
MOE
=
Short
term
Margin
of
Exposure.
MOEs
that
are
<
3000
are
of
concern
for
short
term
exposures
and
are
shown
in
bold.
N/
A
=
Not
Applicable.
b
IT
MOE
=
Intermediate
term
Margin
of
Exposure.
MOEs
that
are
<
1000
are
of
concern
for
intermediate
term
exposures
and
are
shown
in
bold.
N/
A
=
Not
Applicable.
Uncertainties
Chemical
specific
data
from
a
turf
transferable
residue
(
TTR)
study
(
MRID
44690801)
were
available.
However,
these
TTR
data
were
found
to
be
generally
unacceptable
for
use
in
postapplication
exposure
assessment.
These
data
had
limitations,
as
follows:
1)
the
sampling
period
was
not
sufficiently
long
enough
to
adequately
characterize
dissipation;
2)
only
duplicate
samples
were
collected
at
each
sampling
interval,
not
the
Agency
recommended
triplicate
sampling;
and
3)
the
day
0
(
DAT
0)
data
from
the
California
site
were
inconsistent
with
data
from
the
other
two
sites.
Therefore,
based
on
the
weight
of
evidence
these
data
were
discounted.
However,
a
dissipation
rate
(
8%
daily)
derived
from
these
data
was
used
and
translated
to
residential
application
and
the
Residential
SOPs
were
utilized
to
estimate
initial
residues
(
i.
e.
DAT
0
residues)
based
on
application
rate
and
to
estimate
contact
rates
with
turf.
This
is
a
slow
dissipation
rate.
Also,
the
data
show
that
6.1%,
0.85%,
and
0.59%
(
for
CA,
IN
&
MS,
respectively)
of
the
applied
fenarimol
was
detected
on
DAT
0.
By
comparison,
the
Agency's
SOP
uses
a
transfer
efficiency
(
percent
of
application
rate)
of
5%.
Therefore,
due
to
the
variability
of
the
study
transfer
efficiency
data,
the
poor
quality
of
the
study
itself,
and
because
no
transfer
coefficient
exists
for
the
California
roller
method
that
was
used
in
this
study,
HED
will
use
the
5%
transfer
efficiency
rate
for
risk
assessment
purposes.
Dislodgeable
foliar
residue
(
DFR)
data
were
available
for
apple
trees.
These
apple
DFR
data
support
the
EFED
conclusions
concerning
the
persistence
of
fenarimol
in
the
environment.
In
the
DFR
study,
detectable
residues
were
still
present
on
leaf
surface
65
days
after
treatment.
The
exposure
estimates
generated
for
the
residential
turf
uses
using
the
Draft
SOPs
are
based
on
some
upper
percentile
assumptions
(
i.
e.,
duration
of
exposure
and
maximum
application
rate
for
short
term
assessments,
and
duration
of
exposure
for
intermediate
term
assessments)
and
are
considered
to
be
representative
of
high
end
exposures.
The
uncertainties
associated
with
this
assessment
stem
from
the
use
of
an
assumed
amount
of
pesticide
retained
on
turf,
and
assumptions
regarding
the
transfer
of
fenarimol
residues.
The
turf
risk
estimates
are
believed
to
be
reasonable
and
protective
estimates,
that
are
based
on
Agency
residential
SOPs
that
incorporated
dissipation
data
from
a
fenarimol
turf
transferrable
residue
study
which
met
most
of
the
OPPTS
guidelines.
Therefore,
the
level
of
confidence
is
fairly
high.
However,
the
20
percent
dermal
absorption
factor
which
was
used
to
generate
dermal
exposure
estimates
may
represent
an
upper
bound
estimate.
By
using
surrogate
study
data
from
PHED,
it
is
assumed
that
pesticides
of
similar
formulation
result
26
in
similar
exposures
when
handled
in
the
same
manner.
Several
handler
assessments
were
completed
using
"
low
quality"
PHED
data
due
to
the
lack
of
a
more
acceptable
data.
HED
assumes
that
the
general
public's
exposure
may
not
be
mitigated
by
use
of
personal
protective
gear.
Therefore,
only
administrative
controls
(
e.
g.,
formulation
changes
or
use
rate
reductions)
are
feasible
methods
of
risk
reduction.
Mitigating
circumstances
for
residential
exposure
to
fenarimol
residues
may
include
the
watering
in
of
the
granular
formulation
to
turf.
This
instruction,
however,
does
not
prevent
contact
with
treated
turf
prior
to
watering
in.
The
current
granular
label
(
EPA
Reg.
No.
228
298)
recommends,
but
does
not
require
watering
in.
The
soluble
concentrate
label
(
EPA
Reg.
No.
62719
142)
does
not
mention
watering
in.
Therefore,
label
language
should
be
strengthened
to
ensure
that
watering
in
occurs
immediately
after
application.
Additionally,
the
current
labeling
does
not
clearly
specify
whether
the
granular
product
(
EPA
Reg.
No.
228
298)
is
for
professional
use
only.
Specific
labeling
would
help
eliminate
unintentional
use
by
residents.
Labeling
should
also
specifically
advise
against
the
hand
dispersal
and
belly
grinder
type
application
methods.
4.4.2
Spray
Drift
Spray
drift
is
always
a
potential
source
of
exposure
to
the
public
near
spraying
operations.
This
is
particularly
the
case
with
aerial
application,
but,
to
a
lesser
extent,
could
also
be
a
potential
source
of
exposure
from
groundboom
application
methods.
The
Agency
has
been
working
with
the
Spray
Drift
Task
Force,
EPA
Regional
Offices
and
State
Lead
Agencies
for
pesticide
regulation
and
other
parties
to
develop
the
best
spray
drift
management
practices.
The
Agency
is
now
requiring
interim
mitigation
measures
for
aerial
applications
that
must
be
placed
on
product
labels/
labeling.
The
Agency
has
completed
its
evaluation
of
the
new
data
base
submitted
by
the
Spray
Drift
Task
Force,
a
membership
of
U.
S.
pesticide
registrants,
and
is
developing
a
policy
on
how
to
appropriately
apply
the
data
and
the
AgDRIFT
computer
model
to
its
risk
assessments
for
pesticides
applied
by
air,
orchard
airblast
and
ground
hydraulic
methods.
After
the
policy
is
in
place,
the
Agency
may
impose
further
refinements
in
spray
drift
management
practices
to
reduce
off
target
drift
and
risks
associated
with
aerial
as
well
as
other
application
types
where
appropriate.
5.0
AGGREGATE
RISK
ASSESSMENT
AND
RISK
CHARACTERIZATION
5.1
Acute
Aggregate
Risk
Assessment
Because
an
acute
toxicity
endpoint
was
not
identified
by
HIARC,
an
acute
aggregate
risk
assessment
is
not
required.
5.2
Short
and
Intermediate
Term
Aggregate
Risk
Assessment
Because
short
and
intermediate
term
risk
estimates
from
the
turf
use
of
fenarimol
exceed
HED's
level
of
concern,
a
short
and
intermediate
term
aggregate
risk
assessment
cannot
be
performed.
Additional
exposure
to
fenarimol
residues
in
food
or
drinking
water
would
only
cause
short
and
intermediateterm
risk
estimates
to
further
exceed
HED's
level
of
concern.
5.3
Chronic
Aggregate
Risk
Assessment
5.3.1
Aggregate
Chronic
Risk
Assessment
The
aggregate
chronic
risk
assessment
for
fenarimol
considers
both
chronic
food
and
drinking
water
27
exposure
to
fenarimol.
Chronic
exposure
to
residues
of
fenarimol
in/
on
food
does
not
exceed
HED's
level
of
concern.
However,
the
EECs
for
both
surface
and
ground
water
exceed
the
chronic
DWLOCs
for
some
or
all
population
subgroups
(
see
below),
indicating
a
potential
concern
for
exposure
through
drinking
water.
Tier
I
EECs
were
calculated
for
the
turf
use
of
fenarimol.
A
Tier
II
model
is
not
available
for
turf.
5.3.2
Chronic
DWLOC
Calculations
HED
has
calculated
drinking
water
levels
of
comparison
(
DWLOCs)
for
chronic
exposure
to
fenarimol
in
surface
and
groundwater
which
are
presented
in
Table
7.
The
DWLOC
chronic
is
the
concentration
in
drinking
water
as
a
part
of
the
aggregate
chronic
exposure
that
occupies
no
more
than
100%
of
the
chronic
PAD
when
considered
together
with
other
sources
of
exposure.
To
calculate
the
DWLOC
for
chronic
exposure
relative
to
a
chronic
toxicity
endpoint,
the
chronic
dietary
food
exposure
(
from
DEEMJ)
was
subtracted
from
the
chronic
PAD
to
obtain
the
acceptable
chronic
exposure
to
fenarimol
in
drinking
water.
DWLOCs
were
then
calculated
using
default
body
weights
and
drinking
water
consumption
figures.
Assumptions
used
in
calculating
the
DWLOCs
include
70
kg
body
weight
for
the
U.
S.
population,
60
kg
body
weight
for
adult
females,
10
kg
body
weight
for
children,
two
liters
of
water
consumption
per
day
for
adults,
and
one
liter
consumption
for
children.
Table
7.
Fenarimol
Summary
of
Chronic
DWLOC
Calculations
Population
Subgroup
cPAD
(
mg/
kg/
day
)
Food
Exposure
(
mg/
kg/
day)
Available
Water
Exposure
(
mg/
kg/
day)
Chronic
DWLO
C
(
g/
L)
EFED
Generated
EECs
Surface
Water
(
Chronic)
(
g/
L)
Ground
Water
(
SCI
GROW)
(
g/
L)
U.
S.
Populationa
0.0006
0.000000
0.0006
21
59
14
Females
13
50
yrs
0.000000
0.0006
18
Children
1
6
yrs
b
0.000002
0.000598
6
All
Infants
0.000001
0.000599
6
EEC
=
Estimated
Environmental
Concentrations
for
fenarimol
(
does
not
include
aqueous
photolytic
degradate)
Fenarimol
surface
water
EECs
are
from
FIRST
modeling
.
DWLOC
=
water
exposure
X
body
weight
(
where
water
exposure
=
cPAD
food
exposure)
Liters
of
water
X10
3
Body
weight
=
70
kg
for
U.
S.
Population,
60
kg
for
females,
10
kg
for
infants
and
children
Consumption
=
2L/
day
for
Adults
and
1L/
day
for
infants
and
children
a
Also
represents
Males
13
19
years,
Males
20+
years,
and
Seniors
55+
b
Also
represents
Children
7
12
years
old.
Upon
comparison
of
the
chronic
DWLOCs
with
the
EECs
for
fenarimol,
estimated
using
conservative
modeling,
all
surface
and
some
ground
water
EECs
are
greater
than
the
DWLOCs
(
Table
7)
for
all
populations.
Consequently,
there
is
a
potential
concern
for
exposure
from
drinking
water
from
surface
water
sources
for
all
populations,
and
for
infants
and
children
from
groundwater
sources.
6.0
Cumulative
Exposure
To
Substances
with
Common
Mechanism
of
Toxicity.
28
The
Food
Quality
Protection
Act
(
1996)
stipulates
that
when
determining
the
safety
of
a
pesticide
chemical,
EPA
shall
base
its
assessment
of
the
risk
posed
by
the
chemical
on,
among
other
things,
available
information
concerning
the
cumulative
effects
to
human
health
that
may
result
from
dietary,
residential,
or
other
non
occupational
exposure
to
other
substances
that
have
a
common
mechanism
of
toxicity.
The
reason
for
consideration
of
other
substances
is
due
to
the
possibility
that
low
level
exposures
to
multiple
chemical
substances
that
cause
a
common
toxic
effect
by
a
common
mechanism
could
lead
to
the
same
adverse
health
effect
as
would
a
higher
level
of
exposure
to
any
of
the
other
substances
individually.
A
person
exposed
to
a
pesticide
at
a
level
that
is
considered
safe
may
in
fact
experience
harm
if
that
person
is
also
exposed
to
other
substances
that
cause
a
common
toxic
effect
by
a
mechanism
common
with
that
of
the
subject
pesticide,
even
if
the
individual
exposure
levels
to
the
other
substances
are
also
considered
safe.
HED
did
not
perform
a
cumulative
risk
assessment
as
part
of
this
risk
assessment
for
fenarimol
because
HED
has
not
yet
initiated
a
review
to
determine
if
there
are
any
other
chemical
substances
that
have
a
mechanism
of
toxicity
common
with
that
of
fenarimol.
For
purposes
of
this
tolerance
reassessment
review,
EPA
has
assumed
that
fenarimol
does
not
have
a
common
mechanism
of
toxicity
with
other
substances.
7.0
TOLERANCE
REASSESSMENT
RECOMMENDATIONS
7.1
Tolerance
Reassessment
Recommendation
Table
8
summarizes
the
tolerance
reassessment
for
fenarimol.
Table
8.
Reassessed
fenarimol
tolerances.
Commodity
Established
Tolerance
(
ppm)
Reassessed
Tolerance
(
ppm)
Comment
[
Correct
Commodity
Definition]
Tolerance
Listed
Under
40
CFR
§
180.421(
a)(
1)
Apple
pomace
(
wet
and
dry)
2.0
0.3
The
available
data
indicate
that
the
tolerance
for
wet
apple
pomace
should
be
reduced.
Dry
apple
pomace
is
no
longer
considered
a
significant
livestock
feed
item.
[
Apple,
wet
pomace]
Apples
0.1
0.1
[
Apple]
Cattle,
fat
0.1
0.01
Cattle,
meat
0.01
0.01
Cattle,
mbyp
0.01
0.05
[
Cattle,
meat
byproducts,
except
kidney]
Cattle,
kidney
0.1
0.01
Cattle,
liver
0.1
Revoke
[
included
in
meat
byproducts]
Eggs
0.01
Revoke
There
are
no
poultry
feed
items
associated
with
presently
registered
uses.
Goat,
fat
0.1
0.01
Goat,
meat
0.01
0.01
Goat,
mbyp
0.01
0.05
[
Goat,
meat
byproducts,
except
kidney]
Commodity
Established
Tolerance
(
ppm)
Reassessed
Tolerance
(
ppm)
Comment
[
Correct
Commodity
Definition]
29
Goat,
kidney
0.1
0.01
Goat,
liver
0.1
Revoke
[
included
in
meat
byproducts]
Hog,
fat
0.1
Revoke
There
are
no
hog
feed
items
associated
with
presently
registered
uses.
Hog,
meat
0.01
Revoke
Hog,
mbyp
0.01
Revoke
Hog,
kidney
0.1
Revoke
Hog,
liver
0.1
Revoke
Horse,
fat
0.1
0.01
Horse,
meat
0.01
0.01
Horse,
mbyp
0.01
0.05
[
Horse,
meat
byproducts,
except
kidney]
Horse,
liver
0.1
Revoke
[
included
in
meat
byproducts]
Horse,
kidney
0.1
0.01
Milk
0.003
Revoke
Category
3
of
40
CFR
§
180.6(
a)
Pears
0.1
0.1
[
Pear]
Pecans
0.1
0.02
[
Pecan]
Poultry,
fat
0.01
Revoke
There
are
no
poultry
feed
items
associated
with
presently
registered
uses.
Poultry,
meat
0.01
Revoke
Poultry,
mbyp
0.01
Revoke
Sheep,
fat
0.1
0.01
Sheep,
meat
0.01
0.01
Sheep,
mbyp
0.01
0.05
[
Sheep,
meat
byproducts,
except
kidney]
Sheep,
kidney
0.1
0.01
Sheep,
liver
0.1
Revoke
[
included
in
meat
byproducts]
Tolerance
Listed
Under
40
CFR
§
180.421(
a)(
2)
Bananas
0.5
(
Not
more
than
0.25
ppm
shall
be
present
in
the
pulp
after
peel
is
removed)
0.25
[
Banana]
Cherries
1.0
1.0
[
Cherry]
Grape
juice
0.6
Revoke
Not
required
based
on
reexamination
of
available
grape
processing
data.
Grape
pomace
(
wet
and
dry)
2.0
Revoke
No
longer
considered
a
significant
livestock
feed
item.
Grapes
0.2
0.1
[
Grape]
Raisin
waste
3.0
Revoke
No
longer
considered
a
significant
livestock
feed
item.
Raisins
0.6
Revoke
Not
required
based
on
reexamination
of
available
grape
processing
data.
Tolerance
Listed
Under
40
CFR
§
180.421(
b)
Commodity
Established
Tolerance
(
ppm)
Reassessed
Tolerance
(
ppm)
Comment
[
Correct
Commodity
Definition]
30
Filberts
0.02
Revoke
(
expired)
Expiration/
revocation
date
of
12/
31/
98
*
Field
trial
data
support
a
0.02
ppm
tolerance
Hops
5
Revoke
(
expired)
Expiration/
revocation
date
of
12/
31/
98
7.2
Codex/
International
Harmonization
The
Codex
Alimentarius
Commission
has
established
several
maximum
residue
limits
(
MRLs)
for
residues
of
fenarimol
in/
on
various
raw
agricultural
and
processed
commodities.
The
Codex
MRLs
are
expressed
in
terms
of
fenarimol
per
se.
A
numerical
comparison
of
the
Codex
MRLs
and
the
corresponding
reassessed
U.
S.
tolerances
is
presented
in
Table
9.
Table
9
shows
that
except
for
cattle
liver,
cherries,
and
pecans,
the
U.
S.
tolerances
and
Codex
MRLs
are
not
in
harmony
with
respect
to
numerical
levels.
Table
9.
Codex
MRLs
and
applicable
U.
S.
tolerances
for
fenarimol.
Recommendations
are
based
on
conclusions
following
reassessment
of
U.
S.
tolerances.
Codex
Reassessed
U.
S.
Tolerance,
ppm
Recommendation
And
Comments
Commodity,
As
Defined
MRL
1
(
mg/
kg)
Apple
pomace,
dry
5
wet
apple
pomace
=
0.3
Dry
apple
pomace
is
no
longer
considered
a
significant
livestock
feed
item.
Artichoke
globe
0.1
Banana
0.2
0.25
Cattle
kidney
0.02
(*)
0.01
(*)
Cattle
liver
0.05
Revoke
covered
by
tolerance
for
meat
byproducts
Cattle
meat
0.02
(*)
0.01
(*)
Cherries
1
1
Dried
grapes
(
currants,
raisins
and
sultanas)
0.2
Revoke
Grapes
0.3
0.1
Hops,
dry
5
Melons,
except
watermelon
0.05
Peach
0.5
Pecan
0.02
(*)
0.02
(*)
Peppers,
sweet
0.5
Pome
fruits
0.3
apple/
pear
=
0.1
Strawberry
1
1
All
MRLs
are
at
CXL
step.
An
asterisk
(*)
signifies
that
the
MRL
or
US
tolerance
was
established
at
or
about
the
limit
of
detection.
31
8.0
DATA
NEEDS
Toxicology:
Dermal
irritation
(
870.2400);
Subchronic
inhalation
(
870.3465);
and
Developmental
Neurotoxicity
(
870.6300).
The
developmental
neurotoxicity
study
being
required
must
include
a
special
protocol
that
assesses
potential
hormonal
effects.
Product
and
Residue
Chemistry:
Additional
data
are
required
concerning
enforcement
analytical
methods,
stability,
storage
stability,
pH,
UV/
Visible
absorption,
density,
octanol/
water
partition
coefficient,
and
solubility
(
OPPTS
830.1800,
6313,
6317,
7000,
7050,
7300,
7550,
and
7840)
of
the
T/
TGAI.
Storage
stability
data
for
livestock
commodities
are
required
to
support
the
storage
intervals
used
in
the
livestock
feeding
studies.
Residential:
Mitigating
circumstances
for
residential
exposure
to
fenarimol
residues
may
include
watering
in
after
application
to
turf.
This
instruction,
however,
does
not
prevent
contact
with
treated
turf
prior
to
watering
in.
The
current
granular
label
(
EPA
Reg.
No.
228
298)
recommends,
but
does
not
require
watering
in.
The
soluble
concentrate
label
(
EPA
Reg.
No.
62719
142)
does
not
mention
watering
in.
Therefore,
label
language
should
be
strengthened
to
ensure
that
watering
in
occurs
immediately
after
application.
Additionally,
the
current
labeling
does
not
clearly
specify
whether
the
granular
product
(
EPA
Reg.
No.
228
298)
is
for
professional
use
only.
Specific
labeling
would
help
eliminate
unintentional
use
by
residents.
Labeling
should
also
specifically
advise
against
the
hand
dispersal
and
belly
grinder
type
application
methods.
32
Appendix
1.
Detailed
tables
describing
residential
exposure
assessment.
Table
10:
Short
Term
Baseline
Residential
Handler
Exposure
and
Risk
Estimates
Exposure
Scenario
(
Scenario
#)
Crop
Application
Ratea
Amount
Treatedb
Short
Term
Baseline
Dermal
Unit
Exposure
(
mg/
lb
ai)
c
Dermal
Dose
(
mg/
kg/
day)
d
Dermal
MOE
e
Inhalation
Unit
Exposure
(
mg/
lb
ai)
f
Inhalation
Dose
(
mg/
kg/
day)
g
Inhalation
MOEh
Combined
Dermal
&
Inhalation
MOEi
Applicator
Applying
Granular
for
Hand
application
(
1)
Turf
2.73
lb
ai
per
acre
0.023
Acres
per
day
430
0.09
390
0.470
0.00049
71,000
390
Mixer/
Loader/
App
Loading/
Applying
Granular
for
Belly
Grinder
application
(
2)
Turf
2.73
lb
ai
per
acre
0.5
Acres
per
day
110
0.51
69
0.062
0.0014
25,000
69
Loading/
Applying
Granular
for
Push
type
spreader
(
ORETF)
application
(
3)
Turf
2.73
lb
ai
per
acre
0.5
Acres
per
day
0.68
0.0032
11,000
0.00091
0.000021
1,700,000
11,000
*
Values
rounded
to
two
significant
figures
a
Maximum
application
rate
based
on
label.
b
Amounts
of
acreage
treated
per
day
are
from
the
Residential
SOP
for
area
treated
in
a
single
day
for
each
exposure
scenario
of
concern.
c
Dermal
Unit
Exposure
(
mg/
lb
ai)
for
hand
and
belly
grinder
application
from
PHED
represents
short
sleeved
shirt
and
shorts,
no
gloves;
open
mixing/
loading
and
application
by
same
person.
Dermal
Unit
Exposure
for
push
type
spreader
from
Outdoor
Residential
Exposure
Task
Force
(
ORETF)
study
OMA003
(
MRID
44972201).
d
Daily
Dermal
Dose
(
mg/
kg/
day)
=
Dermal
Unit
Exposure
(
mg/
lb
ai)
x
lb
ai/
acre
x
Acres
treated
/
day
x
Dermal
Absorption
Factor
(
20%/
100)
/
Body
Weight
(
60
kg).
e
Dermal
MOE
=
LOAEL
(
35
mg/
kg/
day)
/
Daily
Dermal
Dose
mg/
kg/
day).
f
Inhalation
Unit
Exposure
from
PHED
for
hand
and
belly
grinder
application.
Inhalation
Unit
Exposure
for
push
type
spreader
from
Outdoor
Residential
Exposure
Task
Force
(
ORETF)
study
OMA003
(
MRID
44972201).
g
Daily
Inhalation
Dose
(
mg/
kg/
day)
=
Inhalation
Unit
Exposure
(
mg/
lb
ai)
x
lb
ai/
acre
x
Acres
treated/
day
/
Body
Weight
(
60
kg).
h
Inhalation
MOE
=
LOAEL
(
35
mg/
kg/
day)
/
Daily
Inhalation
Dose
mg/
kg/
day).
i
Combined
MOE
=
1
/
(
1
/
Dermal
MOE
+
1
/
Inhalation
MOE)
33
Table
11:
Fenarimol:
Residential
Postapplication
Activities
on
Treated
Turf:
Dermal
Exposure
and
Non
Cancer
Risk
Estimates
Short
term
Risk
Estimates
at
DAT
0
Intermediate
term
Risk
Estimates
Activity
TTR
g/
cm2
DAT
0
(
a)
Transfer
Coefficient
(
cm2/
hr)
(
b)
Dermal
Dose
(
mg/
kg/
day)
(
c)
MOE
(
d)
TTR
g/
cm2(
e)
Transfer
Coefficient
(
cm2/
hr)
(
b)
Dermal
Dose
(
mg/
kg/
day)
(
c)
MOE
(
f)
high
contact
lawn
activities:
adults
1.53
14,500
0.148
240
0.0346
7,300
0.0017
360
high
contact
lawn
activities:
toddler
1.53
5,200
0.212
170
0.0346
2,600
0.0024
250
mowing
turf:
adults
1.53
500
0.00515
6800
0.0346
500
0.000115
5200
golf
course
reentry:
adult
1.53
500
0.0103
3400
0.0346
500
0.00023
2600
a
TTR
source:
Standard
Operating
Procedures
(
SOPs)
for
Residential
Exposure
Assessments,
SOP
2.2:
Postapplication
dermal
potential
dose
from
pesticide
residues
on
turf.
DAT
0
residue
values
were
used
for
the
short
term
assessments
at
day
0
after
application.
TTR
=
AR
x
F
x
(
1
D)
t
x
CF1
x
Cf2,
where
AR
=
application
rate
(
lbs
a.
i./
acre),
F
=
fraction
of
a.
i.
retained
on
foliage
(
unitless),
D
=
fraction
of
residue
that
dissipates
daily
(
unitless),
t
=
postapplication
day
on
which
exposure
is
being
assessed,
CF1
=
weight
unit
conversion
factor
to
convert
the
lbs
a.
i.
in
the
application
rate
to
g
for
the
DFR
value
(
4.54E8
g/
lb),
and
CF2
=
area
unit
conversion
factor
to
convert
the
surface
area
units
(
ft2)
in
the
application
rate
to
cm2
for
the
DFR
value
(
24.7E
9
acre/
cm2);
e.
g.
TTR
at
DAT
0
=
2.73
lbs
a.
i./
acre
x
0.05
x
4.54E8
g/
lb
x
24.7E
9
acre/
cm2
=
1.53
g/
cm2.
The
fraction
of
residue
that
dissipates
daily
(
D
=
8%)
was
derived
from
the
turf
transferrable
residue
study
submitted
by
the
registrant,
i.
e.
MRID
44690801.
b
Transfer
coefficient
from
the
Residential
SOP's
(
02/
01).
c
Dermal
Dose
=
TTR
(
g/
cm2)
x
TC
(
cm2/
hr)
x
conversion
factor
(
1
mg/
1,000
g)
x
exposure
time
(
2
hrs/
day
playing
&
mowing;
4
hrs
golfing)
x
Dermal
Absorption
Factor
(
20%/
100)/
body
weight
(
60
kg
adult
or
15
kg
child
1
6
yrs).
Short
term
MOEs
were
calculated
using
DAT
0
residue
values
and
intermediate
term
MOEs
were
calculated
using
average
residue
values
(
see
below)
and
TC/
2
(
half
TC
values).
d
MOE
=
LOAEL
(
35
mg/
kg/
day;
based
on
a
oral
study)
/
dermal
dose;
Note:
Target
MOE
is
3000
or
greater,
since
a
NOAEL
was
not
established
and
a
LOAEL
is
used.
e
TTR
source:
MRID
44690801.
Although
this
study
was
unacceptable
for
regulatory
purposes,
average
residue
data
were
used
to
estimate
an
intermediate
term
TTR
value.
An
average
residue
value
from
DAT
1
through
DAT
7
residue
values
from
all
three
sites
for
the
four
days
sampled
was
used;
i.
e.
0.185
g/
cm2/
day.
This
value
was
then
normalized
for
the
lower
application
rate
used
with
multiple
applications,
i.
e.
0.51
lbs
ai/
acre
versus
the
2.73
lbs
ai/
acre
maximum
application
rate
used
for
the
field
studies;
i.
e
0.51/
2.73
x
0.185
=
0.0346
g/
cm2/
day.
f
MOE
=
NOAEL
(
0.6
mg/
kg/
day;
based
on
a
oral
study)
/
dermal
dose;
Note:
Target
MOE
is
1000
or
greater.
Note:
TTR
=
turf
transferable
residue
DAT
=
days
after
treatment
34
Table
12.
Residential
Oral
Nondietary
Short
term
Postapplication
Risks
to
Children
from
"
Hand
to
Mouth"
and
Ingestion
Exposure
When
Reentering
Lawns
Treated
with
Fenarimol
Type
of
Exposure
Short
term
Oral
Dosea
(
mg/
kg/
day)
Short
term
MOEb
Intermediate
term
Oral
Dosea
(
mg/
kg/
day)
Intermediate
term
MOEb
(
1)
Hand
to
Mouth
Activity
(
Finger
licking)
0.040768
860
0.007616
78
(
2)
Incidental
Turfgrass
Mouthing
0.010192
3400
0.002
320
(
3)
Incidental
Ingestion
of
Soil
1.367E
4
260,000
0.0000255
2.4E+
4
(
4)
Ingestion
of
Granules
0.156
224
Combined
Oral
Nondietary
(
except
granular
ingestion)
c
0.0511
690
0.00964
62
Combined
Oral
(
except
granular
ingestion)
and
Dermald
140
50
Footnotes:
a
Application
rate
for
the
short
term
estimates
represents
maximum
label
rate
from
current
EPA
registered
labels:
EPA
Reg.
No.
62719
142
soluble
concentrate/
liquid
formulation
&
EPA
Reg.
No.
228
298
granular
product
formulations,
max
rate
is
2.73
lb
ai/
acre
for
both.
For
intermediate
term
estimates,
the
application
rate
of
0.51
lbs
ai/
acre
was
used.
Incidental
oral
doses
were
calculated
using
formulas
presented
in
the
Residential
SOPs
(
updated
1999
2000).
Short
and
intermediate
term
doses
were
calculated
using
the
following
formulas:
(
1)
Hand
to
mouth
oral
dose
to
children
on
the
day
of
treatment
(
mg/
kg/
day)
=
[
application
rate
(
lb
ai/
acre)
x
fraction
of
residue
dislodgeable
from
potentially
wet
hands
(
5%)
x
11.2
(
conversion
factor
to
convert
lb
ai/
acre
to
g/
cm2)]
x
median
surface
area
for
1
3
fingers
(
20
cm2/
event)
x
hand
to
mouth
rate
(
20
events/
hour)
x
exposure
time
(
2
hr/
day)
x
0.001
mg/
µ
g]
x
50%
extraction
by
saliva
/
bw
(
15
kg
child
1
6
yrs).
This
formula
is
based
on
proposed
changes
to
the
December
1999
Residential
SOPs.
[
Note:
The
intermediate
term
estimates
used
10
events
per
hour.]
(
2)
Turf
mouthing
oral
dose
to
child
on
the
day
of
treatment
(
mg/
kg/
day)
=
[
application
rate
(
lb
ai/
acre)
x
fraction
of
residue
dislodgeable
from
potentially
wet
hands
(
20%)
x
11.2
(
conversion
factor
to
convert
lb
ai/
acre
to
g/
cm2)
x
ingestion
rate
of
grass
(
25
cm2/
day)
x
0.001
mg/
µ
g]
/
bw
(
15
kg
child
1
6
yrs).
(
3)
Soil
ingestion
oral
dose
to
child
on
the
day
of
treatment
(
mg/
kg/
day)
=
[(
application
rate
(
lb
ai/
acre)
x
fraction
of
residue
retained
on
uppermost
1
cm
of
soil
(
100%
or
1.0/
cm)
x
4.54e+
08
g/
lb
conversion
factor
x
2.47e
08
acre/
cm2
conversion
factor
x
0.67
cm3/
g
soil
conversion
factor)
x
100
mg/
day
ingestion
rate
x
1.0e
06
g/
g
conversion
factor]
/
bw
(
15
kg;
child
1
6
yrs).
Short
term
dose
based
residue
on
the
soil
on
day
of
application.
(
4)
Granular
pellet
ingestion
(
mg/
kg/
day)
oral
dose
to
child
=
[
granule
ingestion
rate
(
300
mg/
day)
x
fraction
of
ai
of
granule
formulations
(
0.0078)]
/
bw
(
15
kg
child
1
6
yrs).
b
Short
term
MOE
=
LOAEL
(
35
mg/
kg/
day)
/
Oral
Dose
(
mg/
kg/
day).
LOAEL
from
a
rat
cross
fertility
study;
target
MOE
of
3000,
because
a
NOAEL
was
not
established.
Intermediate
term
MOE
=
NOAEL
(
0.6
mg/
kg/
day)
/
Oral
dose
(
mg/
kg/
day).
NOAEL
from
a
two
generation
rat
reproduction
study;
target
MOE
of
1000.
c
Combined
MOEs
=
LOAEL
/
[
sum
of
incidental
oral
doses],
with
a
target
MOEs
of
3000
&
1000
for
short
&
intermediate
term,
respectively.
d
Combined
Dermal
+
Incidental
Oral
MOEs
=
1/
[
1/
MOEdermal
+
1/
MOEoral
];
see
Table
6
for
dermal
MOE
for
high
contact
short
term
activity
on
turf
(
MOE
=
170).
35
Table
13.
Residential
Exposure
Scenario
Descriptions,
Assumptions,
and
Data
Sources
for
the
Use
of
Fenarimol
Exposure
Scenario
(
Number)
Data
Source
Standard
Assumptionsa
Commentsb
Loading/
Applying
with
a
Push
type
Granular
Spreader
(
1)
ORETF
Study
OMA003
MRID
449722
01
0.5
acres
Baseline:
Hand,
dermal,
and
inhalation
(
30
replicates
each)
data
used
to
establish
exposure
values.
Average
laboratory
and
field
recoveries
were
within
guideline
parameters;
data
of
acceptable
quality
(
AB
grade).
Loading/
Applying
Granular
with
a
Belly
grinder
(
2)
SOPs
for
Residential
Exposure
Assessments
(
12/
97)
0.5
acres
turf;
or
0.025
acres
(
1,000
ft2)
for
turf
spot
treatment
Baseline:
Dermal
(
20
45
replicates)
and
hand
(
23
replicates)
exposure
values
are
based
on
ABC
grade
data.
Inhalation
(
40
replicates)
exposure
value
is
based
on
AB
grade
data.
Medium
confidence
in
dermal/
hand
data
and
high
confidence
in
inhalation
data.
Applying
Granular
by
Hand
(
3)
SOPs
for
Residential
Exposure
Assessments
(
12/
97)
0.025
acres
(
1,000
ft2)
for
spot
treatment
Baseline:
Dermal.
hand,
inhalation
(
each
16
replicates)
exposure
values
are
based
on
ABC
grade
data.
Medium
confidence
in
all
data.
"
No
gloved"
hand
exposure
was
back
calculated
applying
a
90
percent
protection
factor
to
"
gloved"
hand
exposure
data;
therefore
a
10x
FQPA
safety
factor
has
been
applied
to
the
hand
exposure.
a
Standard
Assumptions
based
on
HED
estimates.
b
"
Best
Available"
grades
are
defined
by
HED
SOP
for
meeting
Subdivision
U
Guidelines.
Best
available
grades
are
assigned
as
follows:
matrices
with
grades
A
and
B
data
and
a
minimum
of
15
replicates;
if
not
available,
then
grades
A,
B
and
C
data
and
a
minimum
of
15
replicates;
if
not
available,
then
all
data
regardless
of
the
quality
and
number
of
replicates.
Data
confidence
are
assigned
as
follows:
High
=
grades
A
and
B
and
15
or
more
replicates
per
body
part
Medium
=
grades
A,
B,
and
C
and
15
or
more
replicates
per
body
part
Low
=
grades
A,
B,
C,
D
and
E
or
any
combination
of
grades
with
less
than
15
replicates
| epa | 2024-06-07T20:31:43.808038 | regulations | {
"license": "Public Domain",
"url": "https://downloads.regulations.gov/EPA-HQ-OPP-2002-0250-0013/content.txt"
} |
EPA-HQ-OPP-2002-0251-0001 | Notice | "2002-09-25T04:00:00" | Availability of Interim R.E.D. Decision Document for Comment. | 60231
Federal
Register
/
Vol.
67,
No.
186
/
Wednesday,
September
25,
2002
/
Notices
II.
Tentative
Agenda
The
following
outlines
the
tentative
agenda
of
the
2Ð
day
meeting.
1.
Introductions
and
new
members.
2.
Review
of
isoxaflutole
registration
and
monitoring
experiences.
3.
EPA
Office
of
Water
and
Office
of
Pesticide
Program
presentation
and
discussion,
various
topics
including:
319
guidance
development
Re:
How
to
Address
Pesticides
and
Monitoring
Standards
Development/
Setting
and
Selection
of
Priority
Compounds
Resources
for
Surface
Water
Monitoring
Responsibility
for
New
Products
versus
Reregistrations.
4.
Pesticide
regulatory
education
program
(PREP)
report
and
content
of
revised
pesticide/
water
quality
management
plan.
5.
Issue
team
reportÑ
disposal
label
language
project.
6.
Disposal
initiativesÑ
national
pesticide
stewardship
alliance
mamagememt
report.
7.
Iodosulfuron
registration
reviewÑ
issue
team
and
EPA
perspectives.
8.
FY
2003
registration
work
plan
(EPA).
9.
Review
ad
hoc
rosterÑ
FY
2003
work
group
assignments.
10.
Issue
team
reportÑ
registration
authority
project.
11.
EPA
update
on
copper
chromated
arsenate
(CCA)
update.
12.
State
and
regional
reports.
13.
Farm
association
and
environment
review
training
experience.
14.
Office
of
Pesticide
Program
update
15.
Office
of
Enforcement
and
Compliance
Assurance
up
date.
List
of
Subjects
Environmental
protection,
Pesticides
and
pests.
Dated:
September
18,
2002.
Jay
S.
Ellenberger,
Acting
Director,
Field
and
External
Affairs
Division,
Office
of
Pesticide
Programs.
[FR
Doc.
02Ð
24225
Filed
9Ð
24Ð
02;
8:
45
am]
BILLING
CODE
6560–
50–
S
ENVIRONMENTAL
PROTECTION
AGENCY
[OPP–
2002–
0251;
FRL–
7274–
4]
Availability
of
Interim
Reregistration
Eligibility
Decision
Document
for
Comment
AGENCY:
Environmental
Protection
Agency
(EPA).
ACTION:
Notice.
SUMMARY:
This
notice
announces
availability
and
starts
a
60
day
public
comment
period
on
the
Interim
Reregistration
Eligibility
Decision
(IRED)
document
for
the
pesticide
active
ingredient
diazinon.
The
IRED
represents
EPA's
formal
regulatory
assessment
of
the
health
and
environmental
data
base
of
the
subject
chemical
and
presents
the
Agency's
determination
regarding
which
pesticidal
uses
are
eligible
for
reregistration.
DATES:
Comments,
identified
by
docket
ID
number
OPPÐ
2002Ð
0251,
must
be
received
on
or
before
November
25,
2002.
ADDRESSES:
Comments
may
be
submitted
electronically,
by
mail,
or
through
hand
delivery/
courier.
Follow
the
detailed
instructions
as
provided
in
Unit
I.
of
the
SUPPLEMENTARY
INFORMATION.
FOR
FURTHER
INFORMATION
CONTACT:
Laura
Parsons,
Special
Review
and
Reregistration
Division
(7508C),
Office
of
Pesticide
Programs,
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460Ð
0001;
telephone
number:
(703)
305Ð
5776;
e
mail
address:
parsons.
laura@
epa.
gov.
SUPPLEMENTARY
INFORMATION:
I.
General
Information
A.
Does
this
Action
Apply
to
Me?
This
action
is
directed
to
the
public
in
general.
This
action
may,
however,
be
of
interest
to
persons
who
are
or
may
be
required
to
conduct
testing
of
chemical
substances
under
the
Federal
Insecticide,
Fungicide,
and
Rodenticide
Act
(FIFRA)
or
the
Federal
Food,
Drug
and
Cosmetic
Act
(FFDCA);
environmental,
human
health,
and
agricultural
advocates;
pesticides
users;
and
members
of
the
public
interested
in
the
use
of
pesticides.
Since
other
entities
may
also
be
interested,
the
Agency
has
not
attempted
to
describe
all
the
specific
entities
that
may
be
affected
by
this
action.
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
OPPÐ
2002Ð
0251.
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)
305Ð
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/.
To
access
RED
documents
and
RED
fact
sheets
electronically,
go
directly
to
the
REDs
table
on
the
EPA
Office
of
Pesticide
Programs
Home
Page,
at
http://
www.
epa.
gov/
pesticides/
reregistration/
status.
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.
Certain
types
of
information
will
not
be
placed
in
the
EPA
Dockets.
Information
claimed
as
CBI
and
other
information
whose
disclosure
is
restricted
by
statute,
which
is
not
included
in
the
official
public
docket,
will
not
be
available
for
public
viewing
in
EPA's
electronic
public
docket.
EPA's
policy
is
that
copyrighted
material
will
not
be
placed
in
EPA's
electronic
public
docket
but
will
be
available
only
in
printed,
paper
form
in
the
official
public
docket.
To
the
extent
feasible,
publicly
available
docket
materials
will
be
made
available
in
EPA's
electronic
public
docket.
When
a
document
is
selected
from
the
index
list
in
EPA
Dockets,
the
system
will
identify
whether
the
document
is
available
for
viewing
in
EPA's
electronic
public
docket.
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.
EPA
intends
to
work
towards
providing
electronic
access
to
all
of
the
publicly
available
docket
materials
through
EPA's
electronic
public
docket.
For
public
commenters,
it
is
important
to
note
that
EPA's
policy
is
VerDate
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16:
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24,
2002
Jkt
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Frm
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60232
Federal
Register
/
Vol.
67,
No.
186
/
Wednesday,
September
25,
2002
/
Notices
that
public
comments,
whether
submitted
electronically
or
in
paper,
will
be
made
available
for
public
viewing
in
EPA's
electronic
public
docket
as
EPA
receives
them
and
without
change,
unless
the
comment
contains
copyrighted
material,
CBI,
or
other
information
whose
disclosure
is
restricted
by
statute.
When
EPA
identifies
a
comment
containing
copyrighted
material,
EPA
will
provide
a
reference
to
that
material
in
the
version
of
the
comment
that
is
placed
in
EPA's
electronic
public
docket.
The
entire
printed
comment,
including
the
copyrighted
material,
will
be
available
in
the
public
docket.
Public
comments
submitted
on
computer
disks
that
are
mailed
or
delivered
to
the
docket
will
be
transferred
to
EPA's
electronic
public
docket.
Public
comments
that
are
mailed
or
delivered
to
the
docket
will
be
scanned
and
placed
in
EPA's
electronic
public
docket.
Where
practical,
physical
objects
will
be
photographed,
and
the
photograph
will
be
placed
in
EPA's
electronic
public
docket
along
with
a
brief
description
written
by
the
docket
staff.
C.
How
and
To
Whom
Do
I
Submit
Comments?
You
may
submit
comments
electronically,
by
mail,
or
through
hand
delivery/
courier.
To
ensure
proper
receipt
by
EPA,
identify
the
appropriate
docket
ID
number
in
the
subject
line
on
the
first
page
of
your
comment.
Please
ensure
that
your
comments
are
submitted
within
the
specified
comment
period.
Comments
received
after
the
close
of
the
comment
period
will
be
marked
``
late.
''
EPA
is
not
required
to
consider
these
late
comments.
If
you
wish
to
submit
CBI
or
information
that
is
otherwise
protected
by
statute,
please
follow
the
instructions
in
Unit
I.
D.
Do
not
use
EPA
Dockets
or
e
mail
to
submit
CBI
or
information
protected
by
statute.
1.
Electronically.
If
you
submit
an
electronic
comment
as
prescribed
in
this
unit,
EPA
recommends
that
you
include
your
name,
mailing
address,
and
an
email
address
or
other
contact
information
in
the
body
of
your
comment.
Also
include
this
contact
information
on
the
outside
of
any
disk
or
CD
ROM
you
submit,
and
in
any
cover
letter
accompanying
the
disk
or
CD
ROM.
This
ensures
that
you
can
be
identified
as
the
submitter
of
the
comment
and
allows
EPA
to
contact
you
in
case
EPA
cannot
read
your
comment
due
to
technical
difficulties
or
needs
further
information
on
the
substance
of
your
comment.
EPA's
policy
is
that
EPA
will
not
edit
your
comment,
and
any
identifying
or
contact
information
provided
in
the
body
of
a
comment
will
be
included
as
part
of
the
comment
that
is
placed
in
the
official
public
docket,
and
made
available
in
EPA's
electronic
public
docket.
If
EPA
cannot
read
your
comment
due
to
technical
difficulties
and
cannot
contact
you
for
clarification,
EPA
may
not
be
able
to
consider
your
comment.
i.
EPA
Dockets.
Your
use
of
EPA's
electronic
public
docket
to
submit
comments
to
EPA
electronically
is
EPA's
preferred
method
for
receiving
comments.
Go
directly
to
EPA
Dockets
at
http://
www.
epa.
gov/
edocket,
and
follow
the
online
instructions
for
submitting
comments.
Once
in
the
system,
select
``
search,
''
and
then
key
in
docket
ID
number
OPPÐ
2002Ð
0251.
The
system
is
an
``
anonymous
access''
system,
which
means
EPA
will
not
know
your
identity,
e
mail
address,
or
other
contact
information
unless
you
provide
it
in
the
body
of
your
comment.
ii.
E
mail.
Comments
may
be
sent
by
e
mail
to
opp
docket@
epa.
gov,
Attention:
Docket
ID
Number
OPPÐ
2002Ð
0251.
In
contrast
to
EPA's
electronic
public
docket,
EPA's
e
mail
system
is
not
an
``
anonymous
access''
system.
If
you
send
an
e
mail
comment
directly
to
the
docket
without
going
through
EPA's
electronic
public
docket,
EPA's
e
mail
system
automatically
captures
your
e
mail
address.
E
mail
addresses
that
are
automatically
captured
by
EPA's
e
mail
system
are
included
as
part
of
the
comment
that
is
placed
in
the
official
public
docket,
and
made
available
in
EPA's
electronic
public
docket.
iii.
Disk
or
CD
ROM.
You
may
submit
comments
on
a
disk
or
CD
ROM
that
you
mail
to
the
mailing
address
identified
in
Unit
I.
C.
2.
These
electronic
submissions
will
be
accepted
in
WordPerfect
or
ASCII
file
format.
Avoid
the
use
of
special
characters
and
any
form
of
encryption.
2.
By
mail.
Send
your
comments
to:
Public
Information
and
Records
Integrity
Branch
(PIRIB)
(7502C),
Office
of
Pesticide
Programs
(OPP),
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460Ð
0001,
Attention:
Docket
ID
Number
OPPÐ
2002Ð
0251.
3.
By
hand
delivery
or
courier.
Deliver
your
comments
to:
Public
Information
and
Records
Integrity
Branch
(PIRIB),
Office
of
Pesticide
Programs
(OPP),
Environmental
Protection
Agency,
Rm.
119,
Crystal
Mall
#2,
1921
Jefferson
Davis
Hwy.,
Arlington,
VA,
Attention:
Docket
ID
Number
OPPÐ
2002Ð
0251.
Such
deliveries
are
only
accepted
during
the
docket's
normal
hours
of
operation
as
identified
in
Unit
I.
B.
1.
D.
How
Should
I
Submit
CBI
To
the
Agency?
Do
not
submit
information
that
you
consider
to
be
CBI
electronically
through
EPA's
electronic
public
docket
or
by
e
mail.
You
may
claim
information
that
you
submit
to
EPA
as
CBI
by
marking
any
part
or
all
of
that
information
as
CBI
(if
you
submit
CBI
on
disk
or
CD
ROM,
mark
the
outside
of
the
disk
or
CD
ROM
as
CBI
and
then
identify
electronically
within
the
disk
or
CD
ROM
the
specific
information
that
is
CBI).
Information
so
marked
will
not
be
disclosed
except
in
accordance
with
procedures
set
forth
in
40
CFR
part
2.
In
addition
to
one
complete
version
of
the
comment
that
includes
any
information
claimed
as
CBI,
a
copy
of
the
comment
that
does
not
contain
the
information
claimed
as
CBI
must
be
submitted
for
inclusion
in
the
public
docket
and
EPA's
electronic
public
docket.
If
you
submit
the
copy
that
does
not
contain
CBI
on
disk
or
CD
ROM,
mark
the
outside
of
the
disk
or
CD
ROM
clearly
that
it
does
not
contain
CBI.
Information
not
marked
as
CBI
will
be
included
in
the
public
docket
and
EPA's
electronic
public
docket
without
prior
notice.
If
you
have
any
questions
about
CBI
or
the
procedures
for
claiming
CBI,
please
consult
the
person
listed
under
FOR
FURTHER
INFORMATION
CONTACT.
E.
What
Should
I
Consider
as
I
Prepare
My
Comments
for
EPA?
You
may
find
the
following
suggestions
helpful
for
preparing
your
comments:
1.
Explain
your
views
as
clearly
as
possible.
2.
Describe
any
assumptions
that
you
used.
3.
Provide
copies
of
any
technical
information
and/
or
data
you
used
that
support
your
views.
4.
If
you
estimate
potential
burden
or
costs,
explain
how
you
arrived
at
the
estimate
that
you
provide.
5.
Provide
specific
examples
to
illustrate
your
concerns.
6.
Offer
alternative
ways
to
improve
the
notice
or
collection
activity.
7.
Make
sure
to
submit
your
comments
by
the
deadline
in
this
document.
8.
To
ensure
proper
receipt
by
EPA,
be
sure
to
identify
the
docket
ID
number
assigned
to
this
action
in
the
subject
line
on
the
first
page
of
your
response.
You
may
also
provide
the
name,
date,
and
Federal
Register
citation.
II.
Background
A.
What
Action
is
the
Agency
Taking?
The
Agency
has
issued
an
IRED
for
the
pesticide
active
ingredient
diazinon.
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Federal
Register
/
Vol.
67,
No.
186
/
Wednesday,
September
25,
2002
/
Notices
Under
FIFRA,
as
amended
in
1988,
EPA
is
conducting
an
accelerated
reregistration
program
to
reevaluate
existing
pesticides
to
make
sure
they
meet
current
scientific
and
regulatory
standards.
The
data
base
to
support
the
reregistration
of
diazinon
is
substantially
complete.
Taking
into
account
both
the
risks
and
benefits
of
diazinon
uses,
the
Agency
has
determined
that
with
the
adoption
of
all
the
mitigation
measures
recommended
in
the
IRED,
use
of
diazinon
will
not
pose
unreasonable
adverse
risks
to
people
or
the
environment
when
used
according
to
its
currently
approved
labeling.
Please
note
that
this
is
only
an
interim
decision.
Upon
the
Agency's
completion
of
its
assessment
of
the
cumulative
risk
posed
by
the
organophosphates
as
a
class,
EPA
will
issue
a
final
reregistration
eligibility
decision
on
pesticides
containing
diaizinon.
All
registrants
of
pesticide
products
containing
diazinon
will
be
sent
the
appropriate
REDs,
labeling
requirements
and
product
specific
data
requirements
pending
OMB
approval
of
the
diazinon
Data
Call
In.
The
reregistration
program
is
being
conducted
under
Congressionally
mandated
time
frames,
and
EPA
recognizes
both
the
need
to
make
timely
reregistration
decisions
and
to
involve
the
public.
Therefore,
EPA
is
issuing
this
IRED
with
a
60
day
comment
period.
The
comment
period
is
intended
to
provide
an
opportunity
for
public
input
and
a
mechanism
for
initiating
any
necessary
amendment
to
the
IRED.
EPA
invites
comment
specifically
on
the
use
of
the
diazinon
benefit
assessments
which
can
be
found
with
the
diazinon
documents
on
the
EPA's
website
at
http://
www.
epa.
gov/
pesticides/
reregistration/
status.
htm.
All
comments
will
be
carefully
considered
by
the
Agency.
If
any
comment
significantly
affects
this
IRED,
EPA
will
amend
the
IRED
by
publishing
the
amendment
in
the
Federal
Register.
B.
What
is
the
Agency's
Authority
for
Taking
this
Action?
The
legal
authority
for
this
IRED
falls
under
FIFRA,
as
amended
in
1988
and
1996.
Section
4(
g)(
2)(
A)
of
FIFRA
directs
that,
after
submission
of
all
data
concerning
a
pesticide
active
ingredient,
``
the
Administrator
shall
determine
whether
pesticides
containing
such
active
ingredient
are
eligible
for
reregistration,
''
before
calling
in
product
specific
data
on
individual
end
use
products,
and
either
reregistering
products
or
taking
``
other
appropriate
regulatory
action.
''
List
of
Subjects
Environmental
protection,
Chemicals,
Pesticides
and
pests.
Dated:
September
13,
2002.
Lois
Ann
Rossi,
Director,
Special
Review
and
Reregistration
Division,
Office
of
Pesticide
Programs.
[FR
Doc.
02Ð
24231
Filed
9Ð
24Ð
02;
8:
45
am]
BILLING
CODE
6560–
50–
S
ENVIRONMENTAL
PROTECTION
AGENCY
[OPP–
2002–
0214;
FRL–
7194–
1]
Notice
of
Filing
a
Pesticide
Petition
to
Establish
a
Tolerance
fora
Certain
Pesticide
Chemical
in
or
on
Food
AGENCY:
Environmental
Protection
Agency
(EPA).
ACTION:
Notice.
SUMMARY:
This
notice
announces
the
initial
filing
of
a
pesticide
petition
proposing
the
establishment
of
regulations
for
residues
of
a
certain
pesticide
chemical
in
or
on
various
food
commodities.
DATES:
Comments,
identified
by
docket
ID
number
OPPÐ
2002Ð
0214,
must
be
received
on
or
before
October
25,
2002.
ADDRESSES:
Comments
may
be
submitted
by
mail,
electronically,
or
in
person.
Please
follow
the
detailed
instructions
for
each
method
as
provided
in
Unit
I.
C.
of
the
SUPPLEMENTARY
INFORMATION.
To
ensure
proper
receipt
by
EPA,
it
is
imperative
that
you
identify
docket
ID
number
OPPÐ
2002Ð
0214
in
the
subject
line
on
the
first
page
of
your
response.
FOR
FURTHER
INFORMATION
CONTACT:
By
mail:
Andrew
Bryceland,
Biochemical
Pesticides
Branch,
Biopesticides
and
Pollution
Prevention
Division
(7511C),
Office
of
Pesticide
Programs,
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460;
telephone
number:
(703)
305Ð
6928;
e
mail
address;
bryceland.
andrew@
epa.
gov.
SUPPLEMENTARY
INFORMATION:
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:
Categories
NAICS
codes
Examples
of
potentially
affected
entities
Industry
111
Crop
production
112
Animal
production
311
Food
manufacturing
32532
Pesticide
manufacturing
This
listing
is
not
intended
to
be
exhaustive,
but
rather
provides
a
guide
for
readers
regarding
entities
likely
to
be
affected
by
this
action.
Other
types
of
entities
not
listed
in
the
table
could
also
be
affected.
The
North
American
Industrial
Classification
System
(NAICS)
codes
have
been
provided
to
assist
you
and
others
in
determining
whether
or
not
this
action
might
apply
to
certain
entities.
If
you
have
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
Additional
Information,
Including
Copies
of
this
Document
and
Other
Related
Documents?
1.
Electronically.
You
may
obtain
electronic
copies
of
this
document,
and
certain
other
related
documents
that
might
be
available
electronically,
from
the
EPA
Internet
Home
Page
at
http://
www.
epa.
gov/.
To
access
this
document,
on
the
Home
Page
select
``
Laws
and
Regulations,
''
``
Regulations
and
Proposed
Rules,
''
and
then
look
up
the
entry
for
this
document
under
the
``
Federal
RegisterÑ
Environmental
Documents.
''
You
can
also
go
directly
to
the
Federal
Register
listings
at
http://
www.
epa.
gov/
fedrgstr/.
2.
In
person.
The
Agency
has
established
an
official
record
for
this
action
under
docket
ID
number
OPPÐ
2002Ð
0214.
The
official
record
consists
of
the
documents
specifically
referenced
in
this
action,
any
public
comments
received
during
an
applicable
comment
period,
and
other
information
related
to
this
action,
including
any
information
claimed
as
confidential
business
information
(CBI).
This
official
record
includes
the
documents
that
are
physically
located
in
the
docket,
as
well
as
the
documents
that
are
referenced
in
those
documents.
The
public
version
of
the
official
record
does
not
include
any
information
claimed
as
CBI.
The
public
version
of
the
official
record,
which
includes
printed,
paper
versions
of
any
electronic
comments
submitted
during
an
applicable
comment
period,
is
available
for
inspection
in
the
Public
Information
and
Records
Integrity
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| epa | 2024-06-07T20:31:43.832444 | regulations | {
"license": "Public Domain",
"url": "https://downloads.regulations.gov/EPA-HQ-OPP-2002-0251-0001/content.txt"
} |
EPA-HQ-OPP-2002-0251-0039 | Supporting & Related Material | "2002-11-25T05:00:00" | null | November
22,
2002
Public
Information
and
Records
Integrity
Branch
(
7502C)
Office
of
Pesticide
Programs
Environmental
Protection
Agency
1200
Pennsylvania
Avenue,
NW
Washington
DC,
20460
0001
To
Whom
It
May
Concern:
Re:
Diazinon
Availability
of
Interim
Reregistration
Eligibility
Decision
Document
for
Comment;
OPP
2002
0251,
FRL
7274
4
The
U.
S.
Apple
Association
(
USApple)
is
the
national
trade
association
representing
all
segments
of
the
apple
industry.
Members
include
40
state
and
regional
apple
associations
representing
the
9,000
apple
growers
throughout
the
country,
as
well
as
more
than
400
individual
firms
involved
in
the
apple
business.
USApple
appreciates
this
opportunity
to
comment
on
the
critical
need
for
diazinon
use
on
apples.
USApple
understands
that
the
U.
S.
Environmental
Protection
Agency
(
EPA)
plans
to
delete
from
the
current
diazinon
label
all
pests
and
directions
for
use
except
for
one
application
to
control
woolly
apple
aphids.
USApple
wishes
to
emphasize
the
critical
need
for
diazinon
use
on
apples
to
control
woolly
apple
aphid.
No
other
tool
is
available
to
apple
growers
to
control
infestations
of
this
destructive
pest.
This
use
is
needed
to
avoid
debilitating
apple
tree
damage
that
reduces
tree
vigor,
productivity
and
apple
size.
The
inability
to
control
woolly
apple
aphid
will
result
in
lower
productivity,
which
reduces
grower
revenue
and
our
industry's
international
competitiveness.
Therefore,
USApple
supports
the
agency's
plans
to
maintain
this
critical
use.
Additionally,
USApple
urges
the
agency
to
maintain
a
single
application
of
diazinon
to
control
San
Jose
scale
crawlers.
Apple
growers
are
experiencing
greater
persistence
of
scale
in
apple
orchards
due
to
the
loss
of
methyl
parathion
and
chlorpyrifos.
While
pyriproxyfen
(
Esteem
®
)
provides
excellent
control
of
San
Jose
scale
crawlers,
apple
growers
are
concerned
that
this
is
currently
the
only
available
alternative
for
this
pest.
Thus,
USApple
urges
the
agency
to
maintain
this
use
to
assist
apple
growers
with
their
insect
resistance
management
plans
that
would
prolong
the
efficacy
of
pyriproxyfen
and
avoid
future
problems
controlling
San
Jose
scale.
It
has
come
to
USApple's
attention
that
the
use
of
thiamethoxam
(
Actara
®
)
may
be
limited
to
the
states
of
Michigan,
Pennsylvania
and
New
York.
If
thiamethoxam's
use
is
restricted
to
these
states
in
the
future,
many
apple
growers
will
need
diazinon
to
control
rosy
apple
aphids
and
mealybugs.
Thiamethoxam
controls
both
rosy
apple
aphids
and
mealybugs.
However,
if
growers
do
not
have
access
to
this
tool,
diazinon
would
be
the
preferred
alternative.
Should
North
Carolina
growers
lose
the
thiamethoxam
use,
only
dimethoate
and
diazinon
would
be
available
for
adequate
mealybug
control.
Therefore,
USApple
urges
EPA
to
allow
a
single
application
of
diazinon
to
control
rosy
apple
aphids
and
mealybugs.
The
agency's
interim
reregistration
eligibility
decision
for
diazinon
mandates
use
of
diazinon
in
closed
cabs.
USApple
requests
that
the
agency
remove
this
restriction,
since
the
majority
of
apple
growers
either
do
not
use
closed
cab
tractors
or
they
are
impossible
to
use
in
many
orchard
production
systems
currently
in
use
in
the
apple
industry.
The
U.
S.
apple
industry
has
been
transitioning
to
higher
density
orchards
with
narrower
rows
or
trellis
systems
that
cannot
accommodate
the
higher
profile
of
closed
cab
tractors.
Should
the
agency
maintain
this
restriction,
it
will
effectively
prohibit
diazinon
use
on
significant
apple
acreage.
USApple
recommends
the
following
protective
measures
as
an
alternative
when
closed
cabs
are
not
used
for
diazinon
applications:
chemical
resistant
coveralls
over
long
sleeve
shirt
and
long
pants,
chemical
resistant
gloves,
chemical
resistant
footwear
plus
socks,
protective
eyewear,
chemical
resistant
apron
if
exposed
to
the
concentrate,
chemical
resistant
headgear
for
overhead
exposure,
and
A
respirator
with
an
organic
vapor
removing
cartridge
with
a
prefilter
approved
for
pesticides
(
MSHA/
NIOSH
approval
number
prefix
TC
23C),
or
a
canister
approved
for
pesticides
(
MSHA/
NIOSH
approval
number
prefix
TC
14G),
or
a
NIOSHapproved
respirator
with
an
organic
vapor
(
OV)
cartridge
or
canister
with
any
N,
R
or
P
or
He
prefilter.
Note:
The
registrant
must
drop
the
N
series
filter
from
the
respirator
filter
designation
if
the
pesticide
product
contains
or
is
used
with
oil.
USApple
appreciates
your
consideration
of
these
recommendations.
Sincerely
yours,
James
R.
Cranney,
Jr.
Vice
President
| epa | 2024-06-07T20:31:43.837424 | regulations | {
"license": "Public Domain",
"url": "https://downloads.regulations.gov/EPA-HQ-OPP-2002-0251-0039/content.txt"
} |
EPA-HQ-OPP-2002-0251-0052 | Notice | "2002-12-11T05:00:00" | Diazinon; Availability of Interim Reregistration Eligibility Decision Document for Comment; Reopening
of Comment Period | [
Federal
Register:
December
11,
2002
(
Volume
67,
Number
238)]
[
Notices]
[
Page
76175
76176]
From
the
Federal
Register
Online
via
GPO
Access
[
wais.
access.
gpo.
gov]
[
DOCID:
fr11de02
34]
ENVIRONMENTAL
PROTECTION
AGENCY
[
OPP
2002
0251;
FRL
7283
9]
Diazinon;
Availability
of
Interim
Reregistration
Eligibility
Decision
Document
for
Comment;
Reopening
of
Comment
Period
AGENCY:
Environmental
Protection
Agency
(
EPA).
ACTION:
Notice;
reopening
of
comment
period.
SUMMARY:
EPA
issued
a
notice
in
the
Federal
Register
of
September
25,
2002,
announcing
the
availability
and
start
of
a
60
day
public
comment
period
on
the
Interim
Reregistration
Eligibility
Decision
(
IRED)
document
for
the
pesticide
active
ingredient
diazinon.
This
document
is
reopening
the
comment
period
from
November
25,
2002,
to
January
10,
2003.
DATES:
Comments
identified
by
docket
ID
number
OPP
2002
0251
must
be
received
on
or
before
January
10,
2003.
ADDRESSES:
Comments
may
be
submitted
electronically,
by
mail,
or
through
hand
delivery/
courier.
Follow
the
detailed
instructions
as
provided
in
Unit
I.
C.
of
the
SUPPLEMENTARY
INFORMATION
of
the
September
25,
2002
Federal
Register
document.
FOR
FURTHER
INFORMATION
CONTACT:
Laura
Parsons,
Special
Review
and
Reregistration
Division
(
7508C),
Office
of
Pesticide
Programs,
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460
0001;
telephone
number:
(
703)
305
5776;
e
mail
address:
parsons.
laura@
epa.
gov.
SUPPLEMENTARY
INFORMATION:
I.
General
Information
A.
Does
this
Action
Apply
to
Me?
The
Agency
included
in
the
September
25,
2002
Federal
Register
Notice,
a
list
of
those
who
may
be
potentially
affected
by
this
action.
If
you
have
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
ID
number
OPP
2002
0251.
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
are
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/.
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.
C.
How
and
to
Whom
Do
I
Submit
Comments?
To
submit
comments,
or
access
the
official
public
docket,
please
follow
the
detailed
instructions
as
provided
in
Unit
I.
C.
of
the
SUPPLEMENTARY
INFORMATION
of
the
September
25,
2002
Federal
Register
document.
If
you
have
questions,
consult
the
person
listed
under
FOR
FURTHER
INFORMATION
CONTACT.
II.
What
Action
is
EPA
Taking?
This
document
reopens
the
public
comment
period
established
in
the
Federal
Register
of
September
25,
2002
(
67
FR
60231)
(
FRL
7274
4).
In
that
document,
EPA
announced
the
availability
of
the
IRED
for
the
pesticide
active
ingredient
diazinon
and
invited
comment
on
the
benefit
assessments
and
risk
mitigation
in
the
document.
EPA
is
hereby
reopening
the
comment
[[
Page
76176]]
period,
which
ended
on
November
25,
2002,
to
January
10,
2003.
List
of
Subjects
Environmental
protection,
Pesticides
and
pests.
Dated:
November
27,
2002.
Lois
Rossi,
Director,
Registration
Division,
Office
of
Pesticide
Programs.
[
FR
Doc.
02
31242
Filed
12
10
02;
8:
45
am]
BILLING
CODE
6560
50
S
| epa | 2024-06-07T20:31:43.840258 | regulations | {
"license": "Public Domain",
"url": "https://downloads.regulations.gov/EPA-HQ-OPP-2002-0251-0052/content.txt"
} |
EPA-HQ-OPP-2002-0253-0001 | Rule | "2002-09-20T04:00:00" | Diflubenzuron; Pesticide Tolerances for Emergency Exemption. | 59177
Federal
Register
/
Vol.
67,
No.
183
/
Friday,
September
20,
2002
/
Rules
and
Regulations
commodities
to
the
table
in
paragraph
(a)
to
read
as
follows:
§
180.507
Azoxystrobin;
tolerances
for
residues.
(a)
General.
***
Commodity
Parts
per
million
*****
Caneberry
subgroup
.................
5.0
Cranberry
..............
0.50
*****
Hops,
dried
cones
20.0
*****
Pea
and
bean,
dried
shelled,
except
soybean,
subgroup,
except
cowpea,
and
field
pea
............
0.50
Pea
and
bean,
succulent
shelled,
subgroup
except
cowpea
..............
0.50
Pistachio
...............
0.50
*****
Vegetable,
legume,
edible
podded,
subgroup,
except
soybean
.............
3.0
*****
*
*
*
*
*
[FR
Doc.
02–
23808
Filed
9–
19–
02;
8:
45
am]
BILLING
CODE
6560–
50–
S
ENVIRONMENTAL
PROTECTION
AGENCY
40
CFR
Part
180
[OPP–
2002–
0253;
FRL–
7273–
7]
Diflubenzuron;
Pesticide
Tolerances
for
Emergency
Exemption
AGENCY:
Environmental
Protection
Agency
(EPA).
ACTION:
Final
rule.
SUMMARY:
This
regulation
establishes
time
limited
tolerances
for
residues
of
diflubenzuron
in
or
on
forage
and
hay
of
alfalfa.
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
alfalfa.
This
regulation
establishes
a
maximum
permissible
level
for
residues
of
diflubenzuron
in
these
feed
commodities.
The
tolerances
will
expire
and
are
revoked
on
June
30,
2004.
DATES:
This
regulation
is
effective
September
20,
2002.
Objections
and
requests
for
hearings,
identified
by
docket
control
number
OPP–
2002–
0253,
must
be
received
on
or
before
November
19,
2002.
ADDRESSES:
Written
objections
and
hearing
requests
may
be
submitted
by
mail,
in
person,
or
by
courier.
Please
follow
the
detailed
instructions
for
each
method
as
provided
in
Unit
VII.
of
the
SUPPLEMENTARY
INFORMATION.
To
ensure
proper
receipt
by
EPA,
your
objections
and
hearing
requests
must
identify
docket
control
number
OPP–
2002–
0253
in
the
subject
line
on
the
first
page
of
your
response.
FOR
FURTHER
INFORMATION
CONTACT:
By
mail:
Andrea
Conrath,
Registration
Division
(7505C),
Office
of
Pesticide
Programs,
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460;
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
categories
and
entities
may
include,
but
are
not
limited
to:
Categories
NAICS
codes
Examples
of
potentially
affected
entities
Industry
111
112
311
32532
Crop
production
Animal
production
Food
manufacturing
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
the
table
could
also
be
affected.
The
North
American
Industrial
Classification
System
(NAICS)
codes
have
been
provided
to
assist
you
and
others
in
determining
whether
or
not
this
action
might
apply
to
certain
entities.
If
you
have
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
Additional
Information,
Including
Copies
of
This
Document
and
Other
Related
Documents?
1.
Electronically.
You
may
obtain
electronic
copies
of
this
document,
and
certain
other
related
documents
that
might
be
available
electronically,
from
the
EPA
Internet
Home
Page
at
http://
www.
epa.
gov/.
To
access
this
document,
on
the
Home
Page
select
``
Laws
and
Regulations,
''
``
Regulations
and
Proposed
Rules,
''
and
then
look
up
the
entry
for
this
document
under
the
``
Federal
Register—
Environmental
Documents.
''
You
can
also
go
directly
to
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.
2.
In
person.
The
Agency
has
established
an
official
record
for
this
action
under
docket
control
number
OPP–
2002–
0253.
The
official
record
consists
of
the
documents
specifically
referenced
in
this
action,
and
other
information
related
to
this
action,
including
any
information
claimed
as
Confidential
Business
Information
(CBI).
This
official
record
includes
the
documents
that
are
physically
located
in
the
docket,
as
well
as
the
documents
that
are
referenced
in
those
documents.
The
public
version
of
the
official
record
does
not
include
any
information
claimed
as
CBI.
The
public
version
of
the
official
record,
which
includes
printed,
paper
versions
of
any
electronic
comments
submitted
during
an
applicable
comment
period
is
available
for
inspection
in
the
Public
Information
and
Records
Integrity
Branch
(PIRIB),
Rm.
119,
Mall
#
2,
1921
Jefferson
Davis
Hwy.,
Arlington,
VA,
from
8:
30
a.
m.
to
4
p.
m.,
Monday
through
Friday,
excluding
legal
holidays.
The
PIRIB
telephone
number
is
(703)
305–
5805.
II.
Background
and
Statutory
Findings
EPA,
on
its
own
initiative,
in
accordance
with
sections
408(
e)
and
408
(l)(
6)
of
the
Federal
Food,
Drug,
and
Cosmetic
Act
(FFDCA),
21
U.
S.
C.
346a,
is
establishing
tolerances
for
residues
of
the
insecticide
diflubenzuron,
[N[[(
4
chlorophenyl)
amino]
carbonyl]
2,6
difluorobenzamide],
in
or
on
alfalfa,
forage
and
alfalfa,
hay
at
6.0
parts
per
million
(ppm).
These
tolerances
will
expire
and
are
revoked
on
June
30,
2004.
EPA
will
publish
a
document
in
the
Federal
Register
to
remove
the
revoked
tolerances
from
the
Code
of
Federal
Regulations.
Section
408(
l)(
6)
of
the
FFDCA
requires
EPA
to
establish
a
time
limited
tolerance
or
exemption
from
the
requirement
for
a
tolerance
for
pesticide
chemical
residues
in
food
that
will
result
from
the
use
of
a
pesticide
under
an
emergency
exemption
granted
by
EPA
under
section
18
of
FIFRA.
Such
VerDate
Sep<
04>
2002
17:
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19,
2002
Jkt
197001
PO
00000
Frm
00043
Fmt
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Sfmt
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E:\
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20SER1.
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20SER1
59178
Federal
Register
/
Vol.
67,
No.
183
/
Friday,
September
20,
2002
/
Rules
and
Regulations
tolerances
can
be
established
without
providing
notice
or
period
for
public
comment.
EPA
does
not
intend
for
its
actions
on
section
18
related
tolerances
to
set
binding
precedents
for
the
application
of
section
408
and
the
new
safety
standard
to
other
tolerances
and
exemptions.
Section
408(
e)
of
the
FFDCA
allows
EPA
to
establish
a
tolerance
or
an
exemption
from
the
requirement
of
a
tolerance
on
its
own
initiative,
i.
e.,
without
having
received
any
petition
from
an
outside
party.
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)
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)
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.
.
.
.''
Section
18
of
FIFRA
authorizes
EPA
to
exempt
any
Federal
or
State
agency
from
any
provision
of
FIFRA,
if
EPA
determines
that
``
emergency
conditions
exist
which
require
such
exemption.
''
This
provision
was
not
amended
by
the
Food
Quality
Protection
Act
(FQPA).
EPA
has
established
regulations
governing
such
emergency
exemptions
in
40
CFR
part
166.
Recently,
EPA
has
received
objections
to
a
tolerance
it
established
for
diflubenzuron
on
a
different
food
commodity.
The
objections
were
filed
by
the
Natural
Resources
Defense
Council
(NRDC)
and
raised
several
issues
regarding
aggregate
exposure
estimates
and
the
additional
safety
factor
for
the
protection
of
infants
and
children.
Although
these
objections
concern
separate
rulemaking
proceedings
under
the
FFDCA,
EPA
has
considered
whether
it
is
appropriate
to
establish
the
emergency
exemption
tolerances
for
diflubenzuron
while
the
objections
are
still
pending.
Factors
taken
into
account
by
EPA
included
how
close
the
Agency
is
to
concluding
the
proceedings
on
the
objections,
the
nature
of
the
current
action,
whether
NRDC's
objections
raised
frivolous
issues,
and
extent
to
which
the
issues
raised
by
NRDC
had
already
been
considered
by
EPA.
Although
NRDC's
objections
are
not
frivolous,
the
other
factors
all
support
establishing
these
tolerances
at
this
time.
First,
the
objections
proceeding
is
not
near
to
conclusion.
NRDC's
objections
raise
complex
legal,
scientific,
policy,
and
factual
matters
and
on
August
16,
2002,
EPA
extended
(for
an
additional
30
days)
the
public
comment
period
on
these
objections,
first
initiated
for
60
days
in
the
Federal
Register
of
June
19,
2002
(67
FR
41628)
(FRL–
7167–
7)
and
on
August
16,
2002
(67
FR
53505)
(FRL–
7193–
6).
Second,
the
nature
of
the
current
action
is
extremely
time
sensitive
as
it
addresses
an
emergency
situation.
Third,
the
issues
raised
by
NRDC
are
not
new
matters
but
questions
that
have
been
the
subject
of
considerable
study
by
EPA
and
comment
by
stakeholders.
Accordingly,
EPA
is
proceeding
with
establishing
these
tolerances
for
diflubenzuron.
III.
Emergency
Exemption
for
Diflubenzuron
on
Alfalfa
and
FFDCA
Tolerances
The
Applicant
(Utah
Department
of
Agriculture
and
Food)
states
that
outbreaks
of
the
Mormon
cricket
and
various
grasshopper
species
have
increased
in
Utah's
alfalfa
fields
this
season,
due
in
large
part
to
the
drought
being
experienced.
Because
of
the
drought
conditions,
there
is
no
feed
on
public
lands
for
the
insects,
and
the
insects
are
moving
faster
to
the
private
farmland
in
Utah.
Historically,
grasshoppers
and
crickets
have
posed
a
threat
to
all
crops,
even
plaguing
pioneers
150
years
ago.
The
Mormon
cricket
can
be
economically
devastating,
and
destroys
sagebrush,
alfalfa,
small
grains,
seed,
grasses,
and
vegetable
crops.
Grasshoppers
have
also
been
increasing
in
localized
areas
during
the
past
four
years,
and
in
2001,
the
Applicant
states
that
crop
production
was
hit
hard
from
the
heavily
infested
spots
from
both
the
grasshoppers
and
the
Mormon
cricket.
Many
fields
left
untreated
in
2001
experienced
a
100%
reduction
in
yield,
and
the
Applicant
states
that
the
infestation
levels
for
2002
are
even
greater
than
estimated.
While
there
are
several
chemical
controls
registered
for
use
in
Utah
for
crickets
and
grasshoppers,
regulations
prohibiting
more
than
one
application
combined
with
prohibitive
costs
make
multiple
applications
an
ineffective
solution.
The
Applicant
states
that
diflubenzuron
is
the
only
pesticide
that
has
been
proven
effective
for
full
season
control
of
grasshopper
and
cricket
outbreaks.
Diflubenzuron
has
a
longer
period
of
residual
activity
than
the
registered
alternatives,
which
allows
for
control
of
delayed
hatching
nymphs,
later
hatching
grasshopper
species,
and
secondary
infestations,
which
precludes
the
need
for
additional
applications.
The
Applicant
asserts
that
the
registered
alternative
have
very
short
residual
activity
and/
or
are
prohibitively
expensive
for
use
in
this
situation.
Significant
economic
losses
were
expected
to
occur
this
year
for
alfalfa
producers,
without
the
use
of
diflubenzuron
to
control
these
pests.
EPA
has
authorized
under
section
18
of
FIFRA
the
use
of
diflubenzuron
on
alfalfa
for
control
of
the
Mormon
cricket
and
various
grasshopper
species
in
Utah.
After
having
reviewed
the
submission,
EPA
concurs
that
emergency
conditions
exist
for
this
State.
As
part
of
its
assessment
of
this
emergency
exemption,
EPA
assessed
the
potential
risks
presented
by
residues
of
diflubenzuron
in
or
on
alfalfa
forage
and
hay.
In
doing
so,
EPA
considered
the
safety
standard
in
section
408(
b)(
2)
of
the
FFDCA,
and
EPA
decided
that
the
necessary
tolerances
under
section
408(
l)(
6)
of
the
FFDCA
would
be
consistent
with
the
safety
standard
and
with
section
18
of
FIFRA.
Consistent
with
the
need
to
move
quickly
on
the
emergency
exemption
in
order
to
address
an
urgent
non
routine
situation
and
to
ensure
that
the
resulting
food
is
safe
and
lawful,
EPA
is
establishing
these
tolerances
without
notice
and
opportunity
for
public
comment
as
provided
in
section
408(
l)(
6).
Although
these
tolerances
will
expire
and
are
revoked
on
June
30,
2004,
under
section
408(
l)(
5)
of
the
FFDCA,
residues
of
the
pesticide
not
in
excess
of
the
amounts
specified
in
the
tolerances
remaining
in
or
on
alfalfa
forage
and
hay
after
that
date
will
not
be
unlawful,
provided
the
pesticide
is
applied
in
a
manner
that
was
lawful
under
FIFRA,
and
the
residues
do
not
exceed
the
level
that
was
authorized
by
these
tolerances
at
the
time
of
that
application.
EPA
will
take
action
to
revoke
these
tolerances
earlier
if
any
experience
with,
scientific
data
on,
or
other
relevant
information
on
this
pesticide
indicate
that
the
residues
are
not
safe.
Because
these
tolerances
are
being
approved
under
emergency
conditions,
EPA
has
not
made
any
decisions
about
whether
diflubenzuron
meets
EPA's
registration
requirements
for
use
on
alfalfa
or
whether
permanent
tolerances
for
this
use
would
be
appropriate.
Under
these
circumstances,
EPA
does
not
believe
that
these
tolerances
serve
as
a
basis
for
registration
of
diflubenzuron
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183
/
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September
20,
2002
/
Rules
and
Regulations
by
a
State
for
special
local
needs
under
section
24(
c)
of
FIFRA.
Nor
do
these
tolerances
serve
as
the
basis
for
any
State
other
than
Utah
to
use
this
pesticide
on
this
crop
under
section
18
of
FIFRA
without
following
all
provisions
of
EPA's
regulations
implementing
section
18
as
identified
in
40
CFR
part
166.
For
additional
information
regarding
the
emergency
exemption
for
diflubenzuron,
contact
the
Agency's
Registration
Division
at
the
address
provided
under
FOR
FURTHER
INFORMATION
CONTACT.
IV.
Aggregate
Risk
Assessment
and
Determination
of
Safety
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
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)
.
Consistent
with
section
408(
b)(
2)(
D),
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
diflubenzuron
and
to
make
a
determination
on
aggregate
exposure,
consistent
with
section
408(
b)(
2),
for
time
limited
tolerances
for
residues
of
diflubenzuron
in
or
on
alfalfa
hay
and
forage
at
6.0
ppm.
No
alfalfa
residue
data
were
submitted
for
this
request.
The
proposed
use
rate
of
diflubenzuron
for
alfalfa
is
the
same
as
that
registered
for
use
on
grass.
Therefore,
the
data
from
grass
was
translated
to
alfalfa
for
this
section
18
use.
The
established
tolerances
for
meat
and
milk
commodities
are
adequate
to
cover
any
residues
which
may
result
from
this
section
18
use.
Based
upon
previous
feeding
studies,
the
secondary
residues
in
meat
and
milk
will
not
exceed
the
established
tolerances
as
a
result
of
this
section
18
use.
Residues
of
diflubenzuron
in/
on
alfalfa
are
not
expected
to
increase
dietary
exposure.
Since
alfalfa
is
not
consumed
by
humans,
any
exposure
to
residues
of
diflubenzuron
from
this
emergency
exemption
use
will
result
from
the
consumption
of
meat
or
milk.
The
use
of
diflubenzuron
in
alfalfa
is
not
expected
to
result
in
exceedances
of
the
tolerances
that
already
exist
for
meat
and
milk.
Therefore,
establishing
the
alfalfa
tolerances
will
not
increase
the
most
recent
estimated
aggregate
risks
resulting
from
the
use
of
diflubenzuron,
as
discussed
in
the
Federal
Register
for
February
15,
2002
(67
FR
7085)
(FRL–
6821–
7)
final
rule
establishing
a
tolerance
for
residues
of
diflubenzuron
in/
on
pears,
because
in
that
prior
action,
risk
was
estimated
assuming
all
meat
and
milk
commodities
contained
tolerance
level
residues.
Refer
to
the
February
15,
2002
Federal
Register
document
for
a
detailed
discussion
of
the
aggregate
risk
assessments
and
determination
of
safety.
EPA
relies
upon
that
risk
assessment
and
the
findings
made
in
the
Federal
Register
document
in
support
of
this
action.
Below
is
a
brief
summary
of
the
aggregate
risk
assessment.
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.
A
summary
of
the
toxicological
dose
and
endpoints
for
diflubenzuron
for
use
in
human
risk
assessment
is
discussed
in
final
rule
mentioned
above,
published
in
the
Federal
Register
of
February
15,
2002.
EPA
assessed
risk
scenarios
for
diflubenzuron
under
chronic
exposures
only.
Acute
toxicological
endpoints
have
not
been
identified
for
diflubenzuron,
and
there
are
no
registered
or
proposed
uses
which
would
result
in
short
and
intermediateterm
exposure;
thus
these
exposure
analyses
were
not
necessary.
Although
diflubenzuron
itself
is
not
classified
as
a
carcinogen,
two
of
its
metabolites,
PCA
(p
chloroaniline)
and
CPU
pchlorophenylurea
are
probable
human
carcinogens
and
have
been
assigned
Q1*
s.
Since
these
degradates
are
found
in
mushrooms,
milk,
and
liver,
as
a
result
of
diflubenzuron
use,
EPA
has
concluded
that
the
residues
of
concern
are
diflubenzuron
and
its
metabolites
PCA
and
CPU.
The
Dietary
Exposure
Evaluation
Model
(DEEM
TM
)
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:
Anticipated
residue
information
based
on
field
trial
data,
and
percent
of
crop
treated
(%
CT)
information
for
some
commodities
were
used
(Tier
3).
A
value
of
1%
was
used
for
%CT
values
<
1%.
Using
these
exposure
assessments,
the
EPA
concluded
that
exposure
to
diflubenzuron
from
food
will
utilize
<
1%
of
the
chronic
population
adjusted
dose
(cPAD)
for
the
US
Population,
5%
for
Infants
(
1
yr
old),
and
<
1%
for
Children
(1
to
6
years
old).
In
addition,
despite
the
potential
for
dietary
exposure
to
diflubenzuron
in
drinking
water,
after
calculating
drinking
water
levels
of
concern
(DWLOCs)
and
comparing
them
to
conservative
model
estimated
environmental
concentrations
(EECs)
of
diflubenzuron
in
surface
and
ground
water,
EPA
does
not
expect
the
aggregate
exposure
to
exceed
100%
of
the
cPAD,
as
shown
in
the
following
Table
1.
TABLE
1.—
AGGREGATE
RISK
ASSESSMENT
FOR
ACUTE
EXPOSURE
TO
DIFLUBENZURON
Population
Subgroup
cPAD
(mg/
kg)
%
cPAD
(Food)
Surface
Water
EEC
(ppb)
Ground
Water
EEC
(ppb)
Chronic
DWLOC
(ppb)
U.
S.
Population
0.02
<
1
0.09
0.0023
700
All
Infants
(
1
yr)
0.02
5
0.09
0.0023
190
Children
(1
6
yr)
0.02
<
1
0.09
0.0023
200
Cancer
aggregate
risk
assessments
were
not
performed
for
diflubenzuron
and
PCA,
since
diflubenzuron
is
not
a
carcinogen
and
PCA
is
not
a
significant
degradate
in
drinking
water.
The
potential
cancer
risk
from
dietary
(food
only),
exposure
to
residues
of
PCA
is
4.7
x
10
7
,
which
is
negligible.
The
results
of
the
cancer
analysis
for
CPU
indicate
that
the
estimated
cancer
dietary
(food
only)
risk
from
CPU
3.8
x
10
8
associated
with
the
proposed
use
of
diflubenzuron
is
below
the
Agency's
level
of
concern.
In
addition,
there
is
potential
for
chronic
dietary
exposure
to
CPU
in
drinking
water.
After
calculating
DWLOCs
and
comparing
them
to
the
EECs
for
surface
and
ground
water,
EPA
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20,
2002
/
Rules
and
Regulations
does
not
expect
the
aggregate
cancer
risk
to
exceed
EPA's
level
of
concern,
as
shown
in
the
following
Table
2:
TABLE
2.—
AGGREGATE
CANCER
RISK
ASSESSMENT
FOR
EXPOSURE
TO
DIFLUBENZURON
Population
Subgroup
Residential
Exposure
Aggregate
Cancer
Risk
(food
and
residential)
Surface
Water
EEC
(ppb)
Ground
Water
EEC
(ppb)
Cancer
DWLOC
(ppb)
U.
S.
population
0
3.8
x
10
8
0.23
0.065
2.2
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
diflubenzuron
residues.
V.
Other
Considerations
A.
Analytical
Enforcement
Methodology
Adequate
enforcement
methodology
is
available
to
enforce
the
tolerance
expression.
The
method
may
be
requested
from:
Calvin
Furlow,
PRRIB,
IRSD
(7502C),
Office
of
Pesticide
Programs,
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW,
Washington,
DC
20460;
telephone
number:
(703)
305–
5229;
e
mail
address:
furlow.
calvin@
epa.
gov.
B.
International
Residue
Limits
There
are
no
Codex
maximum
residue
limits
(MRLs)
established
for
diflubenzuron
on
alfalfa
forage
and
hay.
Therefore,
no
compatibility
problems
exist
for
the
proposed
tolerances.
C.
Conditions
One
application
may
be
made
using
ground
or
aerial
equipment,
at
a
rate
of
2
fl.
oz.
of
product
(0.0325
lb.
active
ingredient)
per
acre.
A
14
day
preharvest
interval
and
a
12
hour
re
entry
interval
must
be
observed.
VI.
Conclusion
Therefore,
the
tolerances
are
established
for
residues
of
diflubenzuron,
[N[[(
4
chlorophenyl)
amino]
carbonyl]
2,6
difluorobenzamide],
in
or
on
alfalfa
forage,
and
alfalfa
hay
at
6.0
ppm.
VII.
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
of
1996,
EPA
will
continue
to
use
those
procedures,
with
appropriate
adjustments,
until
the
necessary
modifications
can
be
made.
The
new
section
408(
g)
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),
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
control
number
OPP–
2002–
0253
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
November
19,
2002.
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.
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.
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.
3.
Copies
for
the
Docket.
In
addition
to
filing
an
objection
or
hearing
request
with
the
Hearing
Clerk
as
described
in
Unit
VII.
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.
2.
Mail
your
copies,
identified
by
the
docket
control
number
OPP–
2002–
0253,
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.
In
person
or
by
courier,
bring
a
copy
to
the
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20,
2002
/
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and
Regulations
location
of
the
PIRIB
described
in
Unit
I.
B.
2.
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).
VIII.
Regulatory
Assessment
Requirements
This
final
rule
establishes
time
limited
tolerances
under
section
408
of
the
FFDCA.
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
section
18
FIFRA
exemption
under
section
408
of
the
FFDCA,
such
as
the
tolerances
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.
IX.
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:
September
11,
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
374.
2.
Section
180.377
is
amended
by
adding
the
following
language
and
table
under
paragraph
(b)
to
read
as
follows:
§
180.377
Diflubenzuron;
tolerances
for
residues.
*
*
*
*
*
(b)
Section
18
emergency
exemptions.
Time
limited
tolerances
are
established
for
the
residues
of
diflubenzuron
and
its
metabolites
PCA
(p
chloroaniline)
and
CPU
(p
chlorophenylurea),
expressed
as
the
parent
diflubenzuron,
in
connection
with
use
of
the
pesticide
under
section
18
emergency
exemptions
granted
by
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183
/
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20,
2002
/
Rules
and
Regulations
EPA.
The
tolerances
are
specified
in
the
following
table,
and
will
expire
and
are
revoked
on
the
dates
specified.
Commodity
Parts
per
million
Expiration/
revocation
date
Alfalfa,
forage
...............................................................................................................................................
6.0
6/
30/
2004
Alfalfa,
hay
...................................................................................................................................................
6.0
6/
30/
2004
*
*
*
*
*
[FR
Doc.
02–
23819
Filed
9–
19–
02;
8:
45
am]
BILLING
CODE
6560–
50–
S
ENVIRONMENTAL
PROTECTION
AGENCY
40
CFR
Part
180
[OPP–
2002–
0243;
FRL–
7200–
8]
Halosulfuron
methyl;
Pesticide
Tolerance
AGENCY:
Environmental
Protection
Agency
(EPA).
ACTION:
Final
rule.
SUMMARY:
This
regulation
establishes
tolerances
for
residues
of
halosulfuronmethyl
methyl
5[(
4,6
dimethoxy
2
pyrimidinyl)
amino]
carbonyaminosulfonyl
3
chloro
1
methyl
1H
pyrazole
4
carboxylate
in
or
on
asparagus;
vegetables,
fruiting
(except
cucurbits),
group;
bean,
dry,
seed
and
bean,
snap,
succulent.
Gowan
Company
and
Interregional
Research
Project
Number
4
(IR–
4)
requested
these
tolerances
under
the
Federal
Food,
Drug,
and
Cosmetic
Act,
as
amended
by
the
Food
Quality
Protection
Act
of
1996.
DATES:
This
regulation
is
effective
September
20,
2002.
Objections
and
requests
for
hearings,
identified
by
docket
ID
number
OPP–
2002–
0243,
must
be
received
on
or
before
November
19,
2002.
ADDRESSES:
Written
objections
and
hearing
requests
may
be
submitted
by
mail,
in
person,
or
by
courier.
Please
follow
the
detailed
instructions
for
each
method
as
provided
in
Unit
VI.
of
the
SUPPLEMENTARY
INFORMATION.
To
ensure
proper
receipt
by
EPA,
your
objections
and
hearing
requests
must
identify
docket
ID
number
OPP–
2002–
0243
in
the
subject
line
on
the
first
page
of
your
response.
FOR
FURTHER
INFORMATION
CONTACT:
By
mail:
James
A.
Tompkins
and
Hoyt
Jamerson,
Registration
Division
(7505C),
Office
of
Pesticide
Programs,
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460;
telephone
number:
(703)
305–
5687
and
(703)
308–
9368,
respectively;
e
mail
address:
tompkins.
jim@
epa.
gov
and
jamerson.
hoyt@
epa.
gov.
SUPPLEMENTARY
INFORMATION:
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:
Categories
NAICS
codes
Examples
of
potentially
affected
entities
Industry
111
112
311
32532
Crop
production
Animal
production
Food
manufacturing
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
the
table
could
also
be
affected.
The
North
American
Industrial
Classification
System
(NAICS)
codes
have
been
provided
to
assist
you
and
others
in
determining
whether
or
not
this
action
might
apply
to
certain
entities.
If
you
have
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
Additional
Information,
Including
Copies
of
this
Document
and
Other
Related
Documents?
1.
Electronically.
You
may
obtain
electronic
copies
of
this
document,
and
certain
other
related
documents
that
might
be
available
electronically,
from
the
EPA
Internet
home
page
at
http://
www.
epa.
gov/.
To
access
this
document,
on
the
home
page
select
``
Laws
and
Regulations,
''
``
Regulations
and
Proposed
Rules,
''
and
then
look
up
the
entry
for
this
document
under
the
``
Federal
Register—
Environmental
Documents.
''
You
can
also
go
directly
to
theFederal
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.
2.
In
person.
The
Agency
has
established
an
official
record
for
this
action
under
docket
ID
number
OPP–
2002–
0243.
The
official
record
consists
of
the
documents
specifically
referenced
in
this
action,
and
other
information
related
to
this
action,
including
any
information
claimed
as
Confidential
Business
Information
(CBI).
This
official
record
includes
the
documents
that
are
physically
located
in
the
docket,
as
well
as
the
documents
that
are
referenced
in
those
documents.
The
public
version
of
the
official
record
does
not
include
any
information
claimed
as
CBI.
The
public
version
of
the
official
record,
which
includes
printed,
paper
versions
of
any
electronic
comments
submitted
during
an
applicable
comment
period
is
available
for
inspection
in
the
Public
Information
and
Records
Integrity
Branch
(PIRIB),
Rm.
119,
Crystal
Mall
#2,
1921
Jefferson
Davis
Hwy.,
Arlington,
VA,
from
8:
30
a.
m.
to
4
p.
m.,
Monday
through
Friday,
excluding
legal
holidays.
The
PIRIB
telephone
number
is
(703)
305–
5805.
II.
Background
and
Statutory
Findings
In
the
Federal
Register
of
June
3,
2002
(67
FR
38276)
(FRL–
7179–
2),
EPA
issued
a
notice
pursuant
to
section
408
of
the
Federal
Food,
Drug,
and
Cosmetic
Act
(FFDCA),
21
U.
S.
C.
346a,
as
amended
by
the
Food
Quality
Protection
Act
of
1996
(FQPA)
(Public
Law
104–
170),
announcing
the
filing
of
a
pesticide
petition
(PP
1E6322)
by
Interregional
Research
Project
Number
4(
IR–
4),
681
U.
S.
Highway
1
South,
North
Brunswick,
New
Jersey
08902–
3390.
In
addition
to
the
Federal
Register
of
August
31,
2001
(66
FR
45993)
(FRL–
6796–
1),
EPA
issued
a
notice
pursuant
to
section
408
of
the
Federal
Food,
Drug,
and
Cosmetic
Act
(FFDCA)
21
U.
S.
C.
346a,
as
amended
by
the
FQPA
announcing
the
filing
of
pesticide
petitions
0F6169
and
1F6229)
by
Gowan
Company,
P.
O.
Box
5569;
Yuma,
AZ
85366.
These
notices
included
a
summary
of
the
petitions
prepared
by
Gowan
Company,
the
registrant.
There
were
no
comments
received
in
response
to
these
notices
of
filing.
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| epa | 2024-06-07T20:31:43.843840 | regulations | {
"license": "Public Domain",
"url": "https://downloads.regulations.gov/EPA-HQ-OPP-2002-0253-0001/content.txt"
} |
EPA-HQ-OPP-2002-0255-0001 | Notice | "2002-10-30T05:00:00" | Oxyfluorfen; Availability of the Registration Eligibility Decision Document for Comment | 66149
Federal
Register
/
Vol.
67,
No.
210
/
Wednesday,
October
30,
2002
/
Notices
and
health
care
providers
of
the
CFC
phaseout
and
the
transition
to
alternatives.
Accordingly,
applicants
are
strongly
advised
to
present
detailed
information
on
these
points,
including
the
scope
and
cost
of
such
efforts
and
the
medical
and
patient
organizations
involved
in
the
work.
Applicants
should
submit
their
exemption
requests
to
EPA
as
noted
in
the
Addresses
section
at
the
beginning
of
today's
document.
III.
Availability
of
Pharmaceutical
Grade
CFCs
for
the
Year
2005
and
Beyond
The
plant
that
currently
produces
pharmaceutical
grade
CFCs
for
U.
S.
MDIs
is
scheduled
to
close
at
the
end
of
2005.
As
such,
it
is
necessary
for
MDI
manufacturers
who
wish
to
continue
production
after
that
time
to
identify
a
source
of
pharmaceutical
grade
CFC
past
this
date.
The
Parties
to
the
Protocol
have
identified
two
possible
options.
One
is
to
qualify
another
plant
to
continue
to
produce
pharmaceutical
grade
CFCs
on
a
just
in
time
basis.
A
second
option
is
to
request
that
CFCs
be
produced
from
the
existing
plant
in
a
``
final
campaign''
production
of
CFC
to
be
produced
in
2005.
The
CFCs
produced
in
a
final
campaign
could,
in
theory,
then
supply
the
remainder
of
the
transition
to
CFC
free
MDIs.
It
is
important
to
note
that
this
second
option
is
under
consideration
but
has
not
yet
been
approved
by
the
Parties.
In
order
for
EPA
to
plan
effectively
for
the
future
of
the
essential
use
process,
and
in
order
for
the
U.
S.
Government
to
be
fully
informed,
EPA
must
gather
information
about
how
MDI
manufacturers
intend
to
procure
CFCs
after
2005.
Therefore,
we
request
that
all
essential
use
applicants
for
MDIs
answer
the
following
two
questions
as
completely
as
possible.
1.
What
steps
has
your
company
taken
to
ensure
a
continued
supply
of
CFCs
beyond
2005?
Please
be
specific
and
explain
whether
there
are
plans
to
qualify
a
plant
to
produce
pharmaceutical
grade
CFCs.
Please
identify
the
chemical
company,
the
location
of
the
plant,
and
the
date
the
new
plant
is
expected
to
begin
production.
2.
Does
your
company
wish
to
make
an
essential
use
request
for
final
campaign
production
of
pharmaceutical
grade
CFCs
for
the
year
2005
and
beyond?
If
yes,
how
much
CFCs
does
your
company
anticipate
requesting?
The
answers
you
provide
will
be
considered
confidential
business
information,
and
will
only
be
shared
with
authorized
government
officials.
While
we
are
requesting
information
related
to
the
possibility
of
campaign
production
of
CFCs
for
MDIs
in
2005,
we
are
not
requesting
that
companies
make
an
official
nomination
for
campaign
production
in
2005.
If
it
is
determined
that
campaign
production
is
necessary
and
allowed
under
the
Montreal
Protocol,
EPA
will
issue
a
separate
notice
requesting
nominations
for
campaign
production.
Dated:
October
22,
2002.
Robert
Brenner,
Acting
Assistant
Administrator,
Office
of
Air
and
Radiation.
[FR
Doc.
02–
27623
Filed
10–
29–
02;
8:
45
am]
BILLING
CODE
6560–
50–
P
ENVIRONMENTAL
PROTECTION
AGENCY
[FRL–
7402–
1]
Environmental
Laboratory
Advisory
Board
(ELAB)
Meeting
Date,
and
Agenda
AGENCY:
Environmental
Protection
Agency
(EPA).
ACTION:
Notice
of
teleconference
meeting.
SUMMARY:
The
Environmental
Protection
Agency's
Environmental
Laboratory
Advisory
Board
(ELAB)
will
have
a
teleconference
meeting
on
December
18,
2002,
at
11:
00
AM
EDT
to
discuss
the
ideas,
comments,
and
suggestions
presented
at
the
November
21,
2002,
ELAB
Meeting
and
Open
Forum.
Items
to
be
discussed
include:
(1)
Opinions
and
comments
made
at
the
New
Mexico
ELAB
meetings,
(2)
restructuring
of
the
National
Environmental
Laboratory
Accreditation
Conference
(NELAC),
(3)
discussion
on
future
ELAB
recommendations
to
EPA,
and
(4)
recommendations
for
increasing
the
number
of
States
that
are
Accrediting
Authorities.
ELAB
is
soliciting
input
from
the
public
on
these
and
other
issues
related
to
the
National
Environmental
Laboratory
Accreditation
Program
(NELAP)
and
the
NELAC
standards.
Written
comments
on
NELAP
laboratory
accreditation
and
the
NELAC
standards
are
encouraged
and
should
be
sent
to
Mr.
Edward
Kantor,
DFO,
US
EPA,
P.
O.
Box
93478,
Las
Vegas
NV
89193–
3478,
or
faxed
to
(702)
798–
2261,
or
emailed
to
kantor.
edward@
epa.
gov.
Members
of
the
public
are
invited
to
listen
to
the
teleconference
calls
and,
time
permitting,
will
be
allowed
to
comment
on
issues
discussed
during
this
and
previous
ELAB
meetings.
Those
persons
interested
in
attending
should
call
Edward
Kantor
at
702–
798–
2690
to
obtain
teleconference
information.
The
number
of
lines
are
limited
and
will
be
distributed
on
a
first
come,
first
served
basis.
Preference
will
be
given
to
a
group
wishing
to
attend
over
a
request
from
an
individual.
Dated:
October
23,
2002.
John
G.
Lyon,
Director,
Environmental
Sciences
Division,
National
Environmental
Research
Laboratory.
[FR
Doc.
02–
27624
Filed
10–
29–
02;
8:
45
am]
BILLING
CODE
6560–
50–
P
ENVIRONMENTAL
PROTECTION
AGENCY
[OPP–
2002–
0255;
FRL–
7275–
1]
Oxyfluorfen;
Availability
of
Reregistration
Eligibility
Decision
Document
for
Comment
AGENCY:
Environmental
Protection
Agency
(EPA).
ACTION:
Notice.
SUMMARY:
This
notice
announces
availability
and
starts
a
60–
day
public
comment
period
on
the
Reregistration
Eligibility
Decision
(RED)
document
for
the
pesticide
active
ingredient
oxyfluorfen.
The
RED
represents
EPA's
formal
regulatory
assessment
of
the
health
and
environmental
data
base
of
the
subject
chemical
and
presents
the
Agency's
determination
regarding
which
pesticidal
uses
are
eligible
for
reregistration.
DATES:
Comments,
identified
by
docket
ID
number
OPP–
2002–
0255,
must
be
received
on
or
before
December
30,
2002.
ADDRESSES:
Comments
may
be
submitted
electronically,
by
mail,
or
through
hand
delivery/
courier.
Follow
the
detailed
instructions
as
provided
in
Unit
I.
of
the
SUPPLEMENTARY
INFORMATION.
FOR
FURTHER
INFORMATION
CONTACT:
Patrick
Dobak,
Special
Review
and
Reregistration
Division
(7508C),
Office
of
Pesticide
Programs,
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460;
telephone
number:
(703)
308–
8180;
email
address:
dobak.
pat@
epa.
gov.
SUPPLEMENTARY
INFORMATION:
I.
General
Information
A.
Does
This
Action
Apply
to
Me?
This
action
is
directed
to
the
public
in
general.
This
action
may,
however,
be
of
interest
to
persons
who
are
or
may
be
required
to
conduct
testing
of
chemical
substances
under
the
Federal
Insecticide,
Fungicide,
and
Rodenticide
Act
(FIFRA)
or
the
Federal
Food,
Drug,
and
Cosmetic
Act
(FFDCA);
environmental,
human
health,
and
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Register
/
Vol.
67,
No.
210
/
Wednesday,
October
30,
2002
/
Notices
agricultural
advocates;
pesticides
users;
and
members
of
the
public
interested
in
the
use
of
pesticides.
Since
other
entities
may
also
be
interested,
the
Agency
has
not
attempted
to
describe
all
the
specific
entities
that
may
be
affected
by
this
action.
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
ID
number
OPP–
2002–
0255.
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/.
To
access
RED
documents
and
RED
fact
sheets
electronically,
go
directly
to
the
REDs
table
on
the
EPA
Office
of
Pesticide
Programs
Home
Page,
at
http://
www.
epa.
gov/
pesticides/
reregistration/
status.
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.
Certain
types
of
information
will
not
be
placed
in
EPA's
Dockets.
Information
claimed
as
CBI
and
other
information
whose
disclosure
is
restricted
by
statute,
which
is
not
included
in
the
official
public
docket,
will
not
be
available
for
public
viewing
in
EPA's
electronic
public
docket.
EPA's
policy
is
that
copyrighted
material
will
not
be
placed
in
EPA's
electronic
public
docket,
but
will
be
available
only
in
printed,
paper
form
in
the
official
public
docket.
To
the
extent
feasible,
publicly
available
docket
materials
will
be
made
available
in
EPA's
electronic
public
docket.
When
a
document
is
selected
from
the
index
list
in
EPA
Dockets,
the
system
will
identify
whether
the
document
is
available
for
viewing
in
EPA's
electronic
public
docket.
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.
EPA
intends
to
work
towards
providing
electronic
access
to
all
of
the
publicly
available
docket
materials
through
EPA's
electronic
public
docket.
For
public
commenters,
it
is
important
to
note
that
EPA's
policy
is
that
public
comments,
whether
submitted
electronically
or
in
paper,
will
be
made
available
for
public
viewing
in
EPA's
electronic
public
docket
as
EPA
receives
them
and
without
change,
unless
the
comment
contains
copyrighted
material,
CBI,
or
other
information
whose
disclosure
is
restricted
by
statute.
When
EPA
identifies
a
comment
containing
copyrighted
material,
EPA
will
provide
a
reference
to
that
material
in
the
version
of
the
comment
that
is
placed
in
EPA's
electronic
public
docket.
The
entire
printed
comment,
including
the
copyrighted
material,
will
be
available
in
the
public
docket.
Public
comments
submitted
on
computer
disks
that
are
mailed
or
delivered
to
the
docket
will
be
transferred
to
EPA's
electronic
public
docket.
Public
comments
that
are
mailed
or
delivered
to
the
docket
will
be
scanned
and
placed
in
EPA's
electronic
public
docket.
Where
practical,
physical
objects
will
be
photographed,
and
the
photograph
will
be
placed
in
EPA's
electronic
public
docket
along
with
a
brief
description
written
by
the
docket
staff.
C.
How
and
To
Whom
Do
I
Submit
Comments?
You
may
submit
comments
electronically,
by
mail,
or
through
hand
delivery/
courier.
To
ensure
proper
receipt
by
EPA,
identify
the
appropriate
docket
ID
number
in
the
subject
line
on
the
first
page
of
your
comment.
Please
ensure
that
your
comments
are
submitted
within
the
specified
comment
period.
Comments
received
after
the
close
of
the
comment
period
will
be
marked
``
late.
''
EPA
is
not
required
to
consider
these
late
comments.
If
you
wish
to
submit
CBI
or
information
that
is
otherwise
protected
by
statute,
please
follow
the
instructions
in
Unit
I.
D.
Do
not
use
EPA
Dockets
or
e
mail
to
submit
CBI
or
information
protected
by
statute.
1.
Electronically.
If
you
submit
an
electronic
comment
as
prescribed
in
this
unit,
EPA
recommends
that
you
include
your
name,
mailing
address,
and
an
email
address
or
other
contact
information
in
the
body
of
your
comment.
Also
include
this
contact
information
on
the
outside
of
any
disk
or
CD
ROM
you
submit,
and
in
any
cover
letter
accompanying
the
disk
or
CD
ROM.
This
ensures
that
you
can
be
identified
as
the
submitter
of
the
comment
and
allows
EPA
to
contact
you
in
case
EPA
cannot
read
your
comment
due
to
technical
difficulties
or
needs
further
information
on
the
substance
of
your
comment.
EPA's
policy
is
that
EPA
will
not
edit
your
comment,
and
any
identifying
or
contact
information
provided
in
the
body
of
a
comment
will
be
included
as
part
of
the
comment
that
is
placed
in
the
official
public
docket,
and
made
available
in
EPA's
electronic
public
docket.
If
EPA
cannot
read
your
comment
due
to
technical
difficulties
and
cannot
contact
you
for
clarification,
EPA
may
not
be
able
to
consider
your
comment.
i.
EPA
Dockets.
Your
use
of
EPA's
electronic
public
docket
to
submit
comments
to
EPA
electronically
is
EPA's
preferred
method
for
receiving
comments.
Go
directly
to
EPA
Dockets
at
http://
www.
epa.
gov/
edocket,
and
follow
the
online
instructions
for
submitting
comments.
Once
in
the
system,
select
``
search,
''
and
then
key
in
docket
ID
number
OPP–
2002–
0255.
The
system
is
an
``
anonymous
access''
system,
which
means
EPA
will
not
know
your
identity,
e
mail
address,
or
other
contact
information
unless
you
provide
it
in
the
body
of
your
comment.
ii.
E
mail.
Comments
may
be
sent
by
e
mail
to
opp
docket@
epa.
gov,
Attention:
Docket
ID
number
OPP–
2002–
0255.
In
contrast
to
EPA's
electronic
public
docket,
EPA's
e
mail
system
is
not
an
``
anonymous
access''
system.
If
you
send
an
e
mail
comment
directly
to
the
docket
without
going
through
EPA's
electronic
public
docket,
EPA's
e
mail
system
automatically
captures
your
e
mail
address.
E
mail
addresses
that
are
automatically
captured
by
EPA's
e
mail
system
are
included
as
part
of
the
comment
that
is
placed
in
the
official
public
docket,
and
made
available
in
EPA's
electronic
public
docket.
iii.
Disk
or
CD
ROM.
You
may
submit
comments
on
a
disk
or
CD
ROM
that
you
mail
to
the
mailing
address
identified
in
Unit
I.
C.
2.
These
electronic
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/
Vol.
67,
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210
/
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October
30,
2002
/
Notices
submissions
will
be
accepted
in
WordPerfect
or
ASCII
file
format.
Avoid
the
use
of
special
characters
and
any
form
of
encryption.
2.
By
mail.
Send
your
comments
to:
Public
Information
and
Records
Integrity
Branch
(PIRIB),
Office
of
Pesticide
Programs
(OPP),
Environmental
Protection
Agency
(7502C),
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460.
Attention:
Docket
ID
number
OPP–
2002–
0255.
3.
By
hand
delivery
or
courier.
Deliver
your
comments
to:
Public
Information
and
Records
Integrity
Branch
(PIRIB),
Office
of
Pesticide
Programs
(OPP),
Environmental
Protection
Agency,
Rm.
119,
Crystal
Mall
#2,
1921
Jefferson
Davis
Hwy.,
Arlington,
VA,
Attention:
Docket
ID
number
OPP–
2002–
0255.
Such
deliveries
are
only
accepted
during
the
docket's
normal
hours
of
operation
as
identified
in
Unit
I.
B.
1.
D.
How
Should
I
Submit
CBI
to
the
Agency?
Do
not
submit
information
that
you
consider
to
be
CBI
electronically
through
EPA's
electronic
public
docket
or
by
e
mail.
You
may
claim
information
that
you
submit
to
EPA
as
CBI
by
marking
any
part
or
all
of
that
information
as
CBI
(if
you
submit
CBI
on
disk
or
CD
ROM,
mark
the
outside
of
the
disk
or
CD
ROM
as
CBI
and
then
identify
electronically
within
the
disk
or
CD
ROM
the
specific
information
that
is
CBI).
Information
so
marked
will
not
be
disclosed
except
in
accordance
with
procedures
set
forth
in
40
CFR
part
2.
In
addition
to
one
complete
version
of
the
comment
that
includes
any
information
claimed
as
CBI,
a
copy
of
the
comment
that
does
not
contain
the
information
claimed
as
CBI
must
be
submitted
for
inclusion
in
the
public
docket
and
EPA's
electronic
public
docket.
If
you
submit
the
copy
that
does
not
contain
CBI
on
disk
or
CD
ROM,
mark
the
outside
of
the
disk
or
CD
ROM
clearly
that
it
does
not
contain
CBI.
Information
not
marked
as
CBI
will
be
included
in
the
public
docket
and
EPA's
electronic
public
docket
without
prior
notice.
If
you
have
any
questions
about
CBI
or
the
procedures
for
claiming
CBI,
please
consult
the
person
listed
under
FOR
FURTHER
INFORMATION
CONTACT.
E.
What
Should
I
Consider
as
I
Prepare
My
Comments
for
EPA?
You
may
find
the
following
suggestions
helpful
for
preparing
your
comments:
1.
Explain
your
views
as
clearly
as
possible.
2.
Describe
any
assumptions
that
you
used.
3.
Provide
copies
of
any
technical
information
and/
or
data
you
used
that
support
your
views.
4.
If
you
estimate
potential
burden
or
costs,
explain
how
you
arrived
at
the
estimate
that
you
provide.
5.
Provide
specific
examples
to
illustrate
your
concerns.
6.
Offer
alternative
ways
to
improve
the
notice
or
collection
activity.
7.
Make
sure
to
submit
your
comments
by
the
deadline
in
this
document.
8.
To
ensure
proper
receipt
by
EPA,
be
sure
to
identify
the
docket
ID
number
assigned
to
this
action
in
the
subject
line
on
the
first
page
of
your
response.
You
may
also
provide
the
name,
date,
and
Federal
Register
citation.
II.
Background
A.
What
Action
Is
the
Agency
Taking?
The
Agency
has
issued
a
RED
for
the
pesticide
active
ingredient
listed
in
this
document.
Under
FIFRA,
as
amended
in
1988,
EPA
is
conducting
an
accelerated
reregistration
program
to
reevaluate
existing
pesticides
to
make
sure
they
meet
current
scientific
and
regulatory
standards.
The
data
base
to
support
the
reregistration
of
the
chemical
listed
in
this
document
is
substantially
complete,
and
the
pesticide's
risks
have
been
mitigated
so
that
it
will
not
pose
unreasonable
risks
to
people
or
the
environment
when
used
according
to
its
approved
labeling.
In
addition,
EPA
is
reevaluating
existing
pesticides
and
reassessing
tolerances
under
the
Food
Quality
Protection
Act
(FQPA)
of
1996.
The
pesticides
included
in
this
notice
also
have
been
found
to
meet
the
FQPA
safety
standard.
All
registrants
of
pesticide
products
containing
the
active
ingredient
listed
in
this
document
have
been
sent
the
appropriate
RED,
and
must
respond
to
labeling
requirements
and
product
specific
data
requirements
(if
applicable)
within
8
months
of
receipt.
Products
also
containing
other
pesticide
active
ingredients
will
not
be
reregistered
until
those
other
active
ingredients
are
determined
to
be
eligible
for
reregistration.
The
reregistration
program
is
being
conducted
under
Congressionally
mandated
time
frames,
and
EPA
recognizes
both
the
need
to
make
timely
reregistration
decisions
and
to
involve
the
public.
Therefore,
EPA
is
issuing
this
RED
as
a
final
document
with
a
60–
day
comment
period.
Although
the
60–
day
public
comment
period
does
not
affect
the
registrant's
response
due
date,
it
is
intended
to
provide
an
opportunity
for
public
input
and
a
mechanism
for
initiating
any
necessary
amendments
to
the
RED.
All
comments
will
be
considered
by
the
Agency.
If
any
comment
significantly
affects
the
RED,
EPA
will
amend
the
RED
by
publishing
the
amendment
in
the
Federal
Register.
B.
What
Is
the
Agency's
Authority
for
Taking
This
Action?
The
legal
authority
for
these
REDs
falls
under
FIFRA,
as
amended
in
1988
and
1996.
Section
4(
g)(
2)(
A)
of
FIFRA
directs
that,
after
submission
of
all
data
concerning
a
pesticide
active
ingredient,
``
the
Administrator
shall
determine
whether
pesticides
containing
such
active
ingredient
are
eligible
for
reregistration,
''
before
calling
in
product
specific
data
on
individual
enduse
products,
and
either
reregistering
products
or
taking
``
other
appropriate
regulatory
action.
''
List
of
Subjects
Environmental
protection,
Chemicals,
Pesticides
and
pests.
Dated:
October
24,
2002.
Betty
Shackleford,
Acting
Director,
Special
Review
and
Reregistration
Division,
Office
of
Pesticide
Programs.
[FR
Doc.
02–
27626
Filed
10–
29–
02;
8:
45
am]
BILLING
CODE
6560–
50–
S
ENVIRONMENTAL
PROTECTION
AGENCY
[FRL–
7402–
2]
Health
Assessment
of
1,3
Butadiene
AGENCY:
Environmental
Protection
Agency.
ACTION:
Notice
of
Availability.
SUMMARY:
This
notice
announces
the
availability
of
a
final
report
titled,
Health
Assessment
of
1,3
Butadiene
(EPA/
600/
P–
98/
001F),
which
was
prepared
by
the
U.
S.
Environmental
Protection
Agency's
(EPA)
National
Center
for
Environmental
Assessment
(NCEA)
of
the
Office
of
Research
and
Development
(ORD).
DATES:
This
document
will
be
available
on
or
about
October
30,
2002.
ADDRESSES:
The
document
will
be
made
available
electronically
through
the
NCEA
Web
site
(http://
www.
epa.
gov/
ncea).
A
limited
number
of
paper
copies
will
be
available
from
the
EPA's
National
Service
Center
for
Environmental
Publications
(NSCEP),
P.
O.
Box
42419,
Cincinnati,
OH
45242;
telephone:
1–
800–
490–
9198
or
513–
489–
8190;
facsimile:
513–
489–
8695.
Please
provide
your
name,
your
mailing
address,
the
title
and
the
EPA
number
of
the
requested
publication.
VerDate
0ct<
09>
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15:
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Oct
29,
2002
Jkt
200001
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00000
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E:\
FR\
FM\
30OCN1.
SGM
30OCN1
| epa | 2024-06-07T20:31:43.851713 | regulations | {
"license": "Public Domain",
"url": "https://downloads.regulations.gov/EPA-HQ-OPP-2002-0255-0001/content.txt"
} |
EPA-HQ-OPP-2002-0255-0003 | Supporting & Related Material | "2002-10-23T04:00:00" | null | United
States
Prevention,
Pesticides
EPA738
R
02
014
Environmental
Protection
And
Toxic
Substances
October
2002
Agency
(7508W)
Reregistration
Eligibility
Decision
(RED)
OXYFLUORFEN
United
States
Prevention,
Pesticides
EPA
738
F02
013
Environmental
Protection
And
Toxic
Substances
October,
2002
Agency
(7508C)
R.
E.
D.
FACTS
Oxyfluorfen
Pesticide
Reregistration
All
pesticides
sold
or
distributed
in
the
United
States
must
be
registered
by
EPA,
based
on
scientific
studies
showing
that
they
can
be
used
without
posing
unreasonable
risks
to
people
or
the
environment.
Because
of
advances
in
scientific
knowledge,
the
law
requires
that
pesticides
which
were
first
registered
before
November
1,
1984,
be
reregistered
to
ensure
that
they
meet
today's
more
stringent
standards.
In
evaluating
pesticides
for
reregistration,
EPA
obtains
and
reviews
a
complete
set
of
studies
from
pesticide
producers,
describing
the
human
health
and
environmental
effects
of
each
pesticide.
To
implement
provisions
of
the
Food
Quality
Protection
Act
of
1996,
EPA
considers
the
special
sensitivity
of
infants
and
children
to
pesticides,
as
well
as
aggregate
exposure
of
the
public
to
pesticide
residues
from
all
sources,
and
the
cumulative
effects
of
pesticides
and
other
compounds
with
common
mechanisms
of
toxicity.
The
Agency
develops
any
mitigation
measures
or
regulatory
controls
needed
to
effectively
reduce
each
pesticide's
risks.
EPA
then
reregisters
pesticides
that
meet
the
safety
standard
of
the
FQPA
and
can
be
used
without
posing
unreasonable
risks
to
human
health
or
the
environment.
When
a
pesticide
is
eligible
for
reregistration,
EPA
explains
the
basis
for
its
decision
in
a
Reregistration
Eligibility
Decision
(RED)
document.
This
fact
sheet
summarizes
the
information
in
the
RED
document
for
reregistration
case
2670,
oxyfluorfen.
Use
Profile
Oxyfluorfen
is
a
diphenyl
ether
herbicide
used
for
broad
spectrum
pre
and
post
emergent
control
of
annual
broadleaf
and
grassy
weeds
in
a
variety
of
tree
fruit,
nut,
vine,
and
field
crops.
The
largest
agricultural
markets
in
terms
of
total
pounds
active
ingedient
are
wine
grapes
and
almonds.
There
are
also
nonagricultural
ornamental
and
forestry
uses.
Oxyfluorfen
is
also
used
for
weed
control
in
landscapes,
patios,
driveways,
and
similar
areas
in
residential
sites.
Regulatory
History
Oxyfluorfen
was
first
registered
in
the
United
States
in
1979
to
control
preemergent
and
post
emergent
broadleaf
and
grassy
weeds
in
a
variety
of
field,
fruit,
and
vegetable
crops,
ornamentals,
as
well
as
non
crop
sites.
It
is
manufactured
by
Dow
AgroSciences
and
Makhteshim
Agan
under
the
trade
names
Goal
and
Galigan.
Data
call
ins
were
issued
in
1991,
1993,
and
1995.
In
January
2002,
the
risk
assessments
were
made
publicly
available
for
comment
and
a
close
out
conference
call
was
conducted
on
July
25,
2002,
to
discuss
the
risk
management
decisions
and
resultant
changes
to
the
oxyfluorfen
labels.
2
Human
Health
Assessment
Toxicity
Oxyfluorfen
is
of
low
acute
oral,
dermal,
and
inhalation
toxicity.
The
primary
toxic
effects
are
alterations
in
blood
parameters
(anemia)
and
in
the
liver.
Oxyfluorfen
is
classified
as
a
possible
human
carcinogen
based
on
combined
hepatocellular
adenomas/
carcinomas
in
the
mouse
carcinogenicity
study.
A
cancer
potency
factor
(Q1*)
was
used
to
estimate
human
risk.
The
FQPA
Safety
Factor
for
protection
of
infants
and
children
was
reduced
to
1X
for
all
population
subgroups
as
there
was
no
increased
susceptibility
in
animals
due
to
pre
or
postnatal
exposure
to
oxyfluorfen.
Dietary
Exposure
No
adverse
effects
reflecting
a
single
dose
were
identified
in
toxicological
studies;
therefore,
no
acute
endpoint
was
selected
and
an
acute
dietary
risk
assessment
was
not
conducted.
EPA's
dietary
risk
analysis
for
oxyfluorfen
evaluated
chronic
(non
cancer)
and
cancer
risk.
For
these
chronic
food
risk
assessments,
anticipated
residues
were
calculated
using
either
USDA
Pesticide
Data
Program
(PDP)
monitoring
data
or
field
trial
data.
Both
data
sets
are
consistent
in
that
they
show
all
non
detectable
residues.
Based
on
this
analysis,
the
percentage
of
cPAD
utilized
is
expected
to
be
less
than
1
percent
for
the
U.
S.
population
and
all
subpopulations.
Therefore,
the
chronic
(non
cancer)
dietary
risk
estimate
from
food
alone
is
not
of
concern.
Cancer
risk
from
food
is
calculated
by
using
a
linear
low
dose
risk
model
("
Q1*")
to
determine
the
lifetime
cancer
risk
estimate.
The
Agency
generally
considers
risks
greater
than
1
x
10
6
(1
in
1
million)
to
exceed
its
level
of
concern
for
cancer
dietary
exposure.
Using
the
Q1*
of
7.32
x
10
2
results
in
a
maximum
estimated
lifetime
cancer
risk
to
the
U.
S.
general
population
of
3.8
x
10
7
.
Therefore,
the
cancer
risk
from
food
alone
is
also
not
of
concern.
People
may
be
exposed
to
residues
of
oxyfluorfen
through
the
diet.
Tolerances
or
maximum
residue
limits
have
been
established
for
33
fruits,
vegetables
and
nut
trees
as
well
as
meat
commodities
(please
see
40
CFR
180.381).
EPA
has
reassessed
the
oxyfluorfen
tolerances
and
found
that
the
majority
are
acceptable.
New
tolerances
must
be
proposed/
established
for
cotton
gin
byproducts,
soybean
forage,
soybean
hay,
and
grass
forage,
grass
hay,
and
grass
seed
screenings.
Occupational
and
Residential
Exposure
Based
on
current
use
patterns,
handlers
(mixers,
loaders,
and
applicators)
may
be
exposed
to
oxyfluorfen
during
and
after
normal
use
of
liquid
and
granular
formulations
in
agricultural
and
other
settings.
Oxyfluorfen
is
used
in
the
residential
environment
by
homeowners
to
kill
weeds
on
patios,
driveways
and
similar
surfaces.
Oxyfluorfen
homeowner
products
are
intended
solely
for
spot
treatment;
they
are
not
used
for
broadcast
treatment
of
lawns
because
they
kill
grass.
3
FQPA
Considerations
Chronic
(non
cancer)
Aggregate
Risk
This
assessment
addresses
exposure
to
oxyfluorfen
residues
in
food
and
water
only,
as
there
are
no
chronic
residential
scenarios
identified.
Comparison
of
the
chronic
DWLOCs
with
the
environmental
concentrations
of
oxyfluorfen
shows
that
estimated
surface
and
groundwater
concentrations
are
substantially
less
than
the
DWLOCs
for
all
populations.
Consequently,
the
Agency
concludes
that
residues
of
oxyfluorfen
in
food
and
drinking
water
do
not
result
in
a
chronic
aggregate
risk
of
concern.
Short
term
Aggregate
Risk
Short
term
DWLOCs
were
calculated
based
upon
average
food
residues,
and
the
residential
handler
exposure
which
resulted
in
the
greatest
risk
(spot
treatment
of
weeds
using
a
RTU
trigger
pump
sprayer).
DWLOC
calculations
are
for
adults
only
since
the
residential
exposure
is
to
applicators.
Surface
and
ground
water
concentrations
estimated
using
conservative
modeling
are
less
than
the
short
term
DWLOCs
for
oxyfluorfen.
Consequently,
there
are
no
short
term
aggregate
risk
concerns
from
food,
drinking
water
and
residential
exposures.
Cancer
Aggregate
Risk
The
chronic
food
cancer
risk
estimate
of
3.8
x
10
7
,
combined
with
the
highest
residential
cancer
risk
estimate
of
8.7
x
10
7
,
results
in
a
food
+
residential
cancer
risk
of
1.3
x
10
6
.
Since
the
Agency's
level
of
concern
is
1.0
x
10
6
,
cancer
risk
slightly
exceeds
EPA's
level
of
concern
when
considering
both
food
and
residential
exposures.
However,
since
PDP
monitoring
and
field
trial
data
showed
all
residues
on
food
were
non
detects,
the
food
risk
estimate
is
considered
upper
bound.
Screening
level
surface
water
modeling
indicates
that
there
may
be
a
concern
for
oxyfluorfen
in
drinking
water,
but
this
water
modeling
is
also
considered
upper
bound.
Occupational
and
Residential
Risk
Cancer
risk
to
workers
is
of
greater
concern
than
non
cancer
risk.
Occupational
cancer
risks,
when
calculated
without
personal
protective
equipment
or
engineering
controls,
can
range
up
to
1
x
10
3
.
With
the
protection
specified
on
several
current
labels,
most
scenarios
result
in
cancer
risks
in
the
10
5
range.
The
residential
assessment
for
oxyfluorfen
only
addresses
the
applicator,
because
negligible
postapplication
exposure
is
anticipated
from
spot
treatment
of
weeds.
None
of
the
residential
applicator
scenarios
are
of
concern
because
the
short
term
MOEs
are
greater
than
100
and
the
cancer
risks
are
less
than
1.0
x
10
6
.
Environmental
Assessment
Oxyfluorfen
has
the
potential
to
affect
terrestrial
plants
and
aquatic
ecological
systems
at
all
levels,
as
it
is
toxic
to
plants,
invertebrates,
and
fish,
and
has
been
shown
to
drift
from
application
sites
to
nearby
areas.
Birds
and
mammals
may
also
experience
subchronic
and
chronic
effects
from
oxyfluorfen
use.
4
Environmental
Fate
Oxyfluorfen
is
persistent
and
relatively
immobile
in
soil.
The
most
likely
route
of
dissipation
is
soil
binding.
Laboratory
data
suggest
that
once
the
soilbound
oxyfluorfen
reaches
deep
or
turbid
surface
water
it
will
persist
since
it
is
stable
to
hydrolysis
and
since
light
penetration
would
be
limited;
however,
it
may
degrade
by
photolysis
in
clear,
shallow
water.
Oxyfluorfen
can
contaminate
surface
water
through
spray
drift
and
runoff;
however,
it
is
unlikely
to
contaminate
ground
water
because
it
is
relatively
immobile
in
the
soil
column;
therefore,
the
likelihood
of
leaching
is
small.
No
degradates
were
identified,
and
therefore,
only
the
parent,
oxyfluorfen,
is
of
toxicological
concern
for
risk
assessment.
Ecological
Effects
For
acute
exposures,
oxyfluorfen
is
practically
non
toxic
to
birds,
mammals,
and
bees,
and
the
Agency
has
no
risk
concerns.
However,
subchronic
and
chronic
risks
to
terrestrial
birds
and
mammals
do
present
a
concern.
These
toxic
effects
may
be
manifested
as
reproductive,
developmental,
and
hemolytic
consequences.
Assuming
maximum
residue
values,
the
chronic
level
of
concern
is
exceeded
when
oxyfluorfen
is
applied
to
crops
at
application
rates
greater
than
or
equal
to
0.25
lbs
ai/
acre/
year
for
birds
and
greater
than
or
equal
to
2.0
lbs
ai/
acre
for
mammals.
In
addition,
the
potential
of
oxyfluorfen
(as
a
lightdependent
peroxidizing
herbicide)
to
be
more
toxic
in
the
presence
of
intense
light
may
lead
to
the
occurrence
of
more
serious
environmental
effects
that
are
not
predicted
by
standard
guideline
toxicity
tests.
Oxyfluorfen
is
highly
toxic
to
very
highly
toxic
to
fish
and
aquatic
invertebrates.
However,
concentrations
predicted
by
the
Agency's
surface
water
models
from
normal
use
are
generally
not
high
enough
to
cause
an
acute
concern
for
fish.
Chronic
risk
to
fish
and
acute
and
chronic
risk
to
aquatic
invertebrates
may
occur
from
some
uses
of
oxyfluorfen.
There
are
acute
concerns
for
freshwater
algal
plants
for
all
uses
of
oxyfluorfen.
The
risk
to
vascular
aquatic
plants
cannot
be
assessed
due
to
lack
of
data.
Oxyfluorfen
is
expected
and
has
been
shown
to
negatively
impact
seedling
emergence
and
vegetative
vigor
of
terrestrial
plants.
Non
target
terrestrial
plants
are
exposed
to
oxyfluorfen
as
a
result
of
spray
drift
and
runoff
and
most
incidents
reported
to
the
Agency
are
related
to
plants
affected
by
spray
drift.
Acute
levels
of
concern
are
exceeded
for
all
uses
of
oxyfluorfen
for
terrestrial
plants
and
semiaquatic
plants
adjacent
to
treated
areas.
Ecological
Effects
Risk
Assessment
Generally,
the
Agency
believes
that
oxyfluorfen
presents
the
greatest
risks
to
terrestrial
plants
and
to
aquatic
organisms
through
spray
drift
of
liquid
formulations
and
runoff
of
dissolved
and
soil
entrained
oxyfluorfen.
5
Risk
Mitigation
To
lessen
the
risks
of
cancer
from
drinking
water,
occupational
risks,
and
risks
to
wildlife
posed
by
oxyfluorfen,
EPA
is
requiring
the
following
risk
mitigation
measures:
N
Lower
the
maximum
rate
to
1.5
lbs
ai/
broadcast
acre/
season
for
food
crops
and
2
lbs
ai/
acre/
season
for
conifer
seedlings.
N
For
liquid
formulations
and
granulars
applied
to
field
grown
ornamentals,
registrants
have
agreed
to
lower
this
seasonal
maximum
rate
to
4.5
lbs
ai/
A
(1.5
lbs
ai/
A/
application).
For
granulars
applied
to
containerized
ornamentals,
the
rate
will
be
lowered
to
a
seasonal
maximum
of
6
lbs
ai/
A
(2
lbs
ai/
A/
application).
N
Label
language
will
be
added
to
require
25
foot,
no
spray,
vegetative
buffer
zones
around
surface
water
bodies
such
as
rivers,
lakes,
streams,
and
ponds.
N
To
minimize
oxyfluorfen
drift,
only
use
of
a
coarse,
very
coarse,
or
extremely
coarse
spray
will
be
allowed
according
to
the
ASAE
572
definitions
for
standard
nozzles,
or
a
volume
median
diameter
(VMD)
of
385
microns
or
larger
for
spinning
atomizer
nozzles.
N
The
maximum
application
rate
on
residential
products
will
be
reduced
to
3
lbs
ai/
A
or
less
unless
efficacy
data
support
the
need
for
higher
rates.
N
Closed
mixing/
loading
systems
to
support
applications
to
corn,
cotton,
soybeans,
and
aerial
applications
to
fallow
land.
N
Enclosed
cab
for
applications
to
corn,
and
closed
cockpit
aircraft
for
applications
to
fallow
land.
N
Double
layer
Personal
Protective
Equipment
(PPE)
for
all
other
mixers,
loaders,
and
applicators.
Additional
Data
Required
EPA
is
requiring
the
following
additional
generic
studies
for
oxyfluorfen
to
confirm
its
regulatory
assessments
and
conclusions:
21
day
Dermal
Toxicity
Study
in
Rats;
Crop
Field
Trials
in
Bananas
and
Cacao
Beans;
Estuarine/
marine
Fish
Early
life
Stage;
Whole
Sediment
Invertebrate
Freshwater
Acute
Toxicity;
Whole
Sediment
Invertebrate
Estuarine/
marine
Acute
Toxicity;
Seed
Germination/
Seedling
Emergence;
Vegetative
Vigor;
Aquatic
Plant
Growth;
Dislodgeable
Foliar
Residue
Study
in
Conifers;
Fish
Phototoxicity
Study;
and
Edge
of
Field
Water
and
Sediment
Monitoring.
Product
Labeling
Changes
Required
All
oxyfluorfen
end
use
products
must
comply
with
EPA's
current
pesticide
product
labeling
requirements.
For
a
comprehensive
list
of
labeling
requirements,
please
see
the
oxyfluorfen
RED
document.
The
labeling
requirements
table
is
available
as
a
separate
document.
Regulatory
Conclusion
The
use
of
currently
registered
products
containing
oxyfluorfen
in
accordance
with
approved
labeling
will
not
pose
unreasonable
risks
or
adverse
effects
to
humans
or
the
environment.
Therefore,
all
uses
of
these
products
are
eligible
for
reregistration.
6
All
products
will
be
reregistered
once
the
required
product
specific
data,
revised
Confidential
Statements
of
Formula,
and
revised
labeling
are
received
and
accepted
by
EPA.
For
More
Information
EPA
is
requesting
public
comments
on
the
Reregistration
Eligibility
Decision
(RED)
document
for
oxyfluorfen
during
a
60
day
time
period,
as
announced
in
a
Notice
of
Availability
published
in
the
Federal
Register.
To
obtain
a
copy
of
the
RED
document
or
to
submit
written
comments,
please
contact
the
Pesticide
Docket,
Public
Information
and
Records
Integrity
Branch,
Information
Resources
and
Services
Division
(7502C),
Office
of
Pesticide
Programs
(OPP),
US
EPA,
Washington,
DC
20460,
telephone
703
305
5805.
Electronic
copies
of
the
RED
and
this
fact
sheet
are
available
on
the
Internet.
See
http://
www.
epa.
gov/
REDs.
Printed
copies
of
the
RED
and
fact
sheet
can
be
obtained
from
EPA's
National
Service
Center
for
Environmental
Publications
(EPA/
NSCEP),
PO
Box
42419,
Cincinnati,
OH
45242
2419,
telephone
1
800
490
9198;
fax
513
489
8695.
Following
the
comment
period,
the
oxyfluorfen
RED
document
also
will
be
available
from
the
National
Technical
Information
Service
(NTIS),
5285
Port
Royal
Road,
Springfield,
VA
22161,
telephone
1
800
553
6847,
or
703
605
6000.
For
more
information
about
EPA's
pesticide
reregistration
program,
the
oxyfluorfen
RED,
or
reregistration
of
individual
products
containing
oxyfluorfen,
please
contact
the
Special
Review
and
Reregistration
Division
(7508C),
OPP,
US
EPA,
Washington,
DC
20460,
telephone
703
308
8000.
For
information
about
the
health
effects
of
pesticides,
or
for
assistance
in
recognizing
and
managing
pesticide
poisoning
symptoms,
please
contact
the
National
Pesticide
Information
Center
(NPIC).
Call
toll
free
1
800
858
7378,
from
6:
30
am
to
4:
30
pm
Pacific
Time,
or
9:
30
am
to
7:
30
pm
Eastern
Standard
Time,
seven
days
a
week.
Their
internet
address
is
http://
npic.
orst.
edu.
UNITED
STATES
ENVIRONMENTAL
PROTECTION
AGENCY
WASHINGTON,
D.
C.
20460
OFFICE
OF
PREVENTION,
PESTICIDES
AND
TOXIC
SUBSTANCES
CERTIFIED
MAIL
Dear
Registrant:
This
is
to
inform
you
that
the
Environmental
Protection
Agency
(hereafter
referred
to
as
EPA
or
the
Agency)
has
completed
its
review
of
the
available
data
and
public
comments
received
related
to
the
preliminary
risk
assessment
for
the
herbicide
oxyfluorfen.
The
Agency
has
revised
the
human
health
and
environmental
effects
risk
assessments
based
on
the
comments
received
during
the
public
comment
period
and
additional
data
received
from
the
registrant.
Based
on
the
EPA's
revised
risk
assessments
for
oxyfluorfen,
EPA
has
identified
risk
mitigation
measures
that
the
Agency
believes
are
necessary
to
address
the
human
health
and
environmental
risks
associated
with
the
current
use
of
oxyfluorfen.
EPA
is
now
publishing
its
reregistration
eligibility,
risk
management,
and
tolerance
reassessment
decisions
for
the
current
uses
of
oxyfluorfen,
and
its
associated
human
health
and
environmental
risks.
The
Agency's
decision
on
the
individual
chemical
oxyfluorfen
can
be
found
in
the
attached
document
entitled,
"Reregistration
Eligibility
Decision
for
Oxyfluorfen"
which
was
approved
on
August
2,
2002.
A
Notice
of
Availability
for
the
Reregistration
Eligibility
Decision
for
Oxyfluorfen
is
being
published
in
the
Federal
Register.
To
obtain
copies
of
the
RED
document,
please
contact
the
Pesticide
Docket,
Public
Response
and
Program
Resources
Branch,
Field
Operations
Division
(7506C),
Office
of
Pesticide
Programs
(OPP),
USEPA,
Washington,
DC
20460,
telephone
(703)
305
5805.
Electronic
copies
of
the
RED
and
all
supporting
documents
are
available
on
the
Internet.
See
http://
www.
epa.
gov/
pesticides/
reregistration/
status.
htm.
As
part
of
the
Agency's
effort
to
involve
the
public
in
the
implementation
of
the
Food
Quality
Protection
Act
of
1996
(FQPA),
the
Agency
is
undertaking
a
special
effort
to
maintain
open
public
dockets
and
to
engage
the
public
in
the
reregistration
and
tolerance
reassessment
processes.
During
the
public
comment
period,
comments
on
the
risk
assessment
were
submitted
by
Dow
AgroSciences,
the
technical
registrant.
EPA
also
received
letters
from
approximately
65
growers,
extension
agents,
and
commodity
organizations
testifying
to
the
importance
of
oxyfluorfen
to
their
weed
control
programs
for
commodities
such
as
forest
seedlings,
wine
grapes,
artichokes,
raspberries,
blackberries,
strawberries,
garbanzo
beans,
onions,
garlic,
and
almonds.
The
Confederated
Tribes
of
the
Warm
Springs
Reservation
of
Oregon
raised
concern
that
the
dietary
risk
assessment
for
oxyfluorfen
is
not
protective,
because
estimated
fish
consumption
was
based
on
an
amount
representative
of
the
general
public
rather
than
subpopulations
which
may
consume
higher
levels
of
fish.
A
close
out
conference
call
with
interested
stakeholders
was
conducted
on
July
25,
2002
to
discuss
the
risk
management
decisions
and
resultant
changes
to
the
oxyfluorfen
labels.
Please
note
that
the
oxyfluorfen
risk
assessment
and
the
attached
RED
concern
only
this
particular
pesticide.
The
Food
Quality
Protection
Act
(FQPA)
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."
Oxyfluorfen
is
a
diphenyl
ether
herbicide
structurally
related
to
lactofen,
fomesafen
and
acifluorfen.
At
this
time,
the
Agency
has
not
made
a
decision
as
to
whether
oxyfluorfen
shares
a
common
mechanism
of
toxicity
with
these
other
diphenyl
ethers
or
any
other
pesticide.
A
careful
evaluation
of
all
the
available
data
is
still
needed,
as
well
as
peer
review
by
the
FIFRA
Science
Advisory
Panel,
before
a
formal
decision
is
made.
Therefore,
for
the
purposes
of
this
risk
assessment,
the
Agency
has
assumed
that
oxyfluorfen
does
not
share
a
common
mechanism
of
toxicity
with
other
pesticides.
After
a
decision
is
made
regarding
common
mechanism
of
toxicity,
and
if
the
Agency
has
determined
that
a
cumulative
assessment
is
necessary,
the
Agency
will
address
any
outstanding
risk
concerns
at
that
time.
This
document
contains
a
generic
and/
or
a
product
specific
Data
Call
In(
s)
(DCI)
that
outline(
s)
further
data
requirements
for
this
chemical.
Note
that
registrants
of
oxyfluorfen
must
respond
to
DCIs
issued
by
the
Agency
within
90
days
of
receipt
of
this
letter.
This
RED
also
contains
labeling
requirements
for
oxyfluorfen
products.
End
use
product
labels
must
be
revised
by
the
manufacturer
to
adopt
the
changes
set
forth
in
Section
IV
of
this
document.
Instructions
for
registrants
on
submitting
revised
labeling
and
the
time
frame
established
to
do
so
can
be
found
in
Section
V
of
this
document.
Should
a
registrant
fail
to
implement
any
of
the
risk
mitigation
measures
outlined
in
this
document,
the
Agency
will
continue
to
have
concerns
about
the
risks
posed
by
oxyfluorfen.
Where
the
Agency
has
identified
any
unreasonable
adverse
effect
to
human
health
and
the
environment,
the
Agency
may
at
any
time
initiate
appropriate
regulatory
action
to
address
this
concern.
At
that
time,
any
affected
person(
s)
may
challenge
the
Agency's
action.
There
will
be
a
60
day
public
comment
period
for
this
document,
commencing
on
the
day
the
Notice
of
Availability
publishes
in
the
Federal
Register.
If
you
have
questions
on
this
document
or
the
proposed
label
changes,
please
contact
the
Special
Review
and
Reregistration
Division
representative,
John
Leahy
(703)
305
6703.
For
questions
about
product
reregistration
and/
or
the
Product
DCI
that
accompanies
this
document,
please
contact
Bonnie
Adler
at
(703)
308
8523.
Lois
A.
Rossi,
Director
Special
Review
and
Reregistration
Division
Attachment
Reregistration
Eligibility
Decision
(RED)
for
Oxyfluorfen
Case
No.
2490
TABLE
OF
CONTENTS
Executive
Summary
...........................................................
v
I.
Introduction
............................................................
1
II.
Chemical
Overview
......................................................
2
A.
Regulatory
History
..................................................
2
B.
Chemical
Identification
..............................................
3
C.
Use
Profile
.........................................................
3
D.
Estimated
Usage
of
Pesticide
..........................................
5
III.
Summary
of
Oxyfluorfen
Risk
Assessment
...................................
6
A.
Human
Health
Risk
Assessment
......................................
7
1.
Dietary
Risk
from
Food
.........................................
7
a.
Toxicity
.................................................
7
b.
FQPA
Safety
Factor
.......................................
9
c.
Population
Adjusted
Dose
(PAD)
............................
9
d.
Endpoints
and
Doses
for
Risk
Assessment
.....................
9
e.
Exposure
Assumptions
....................................
10
f.
Dietary
Risk
from
Food
...................................
11
2.
Dietary
Risk
from
Drinking
Water
..............................
11
a.
Surface
Water
...........................................
12
b.
Ground
Water
...........................................
13
c.
Drinking
Water
Levels
of
Comparison
(DWLOCs)
............
13
(1)
DWLOCs
for
Chronic
(Cancer
and
Non
cancer)
Exposure
..................................................
13
(2)
Chronic
Dietary
Risk
................................
14
(3)
Cancer
............................................
14
3.
Non
dietary
Risk
from
Residential
Uses
..........................
15
a.
Exposure
...............................................
15
b.
Residential
Handler
Risk
Estimates
.........................
16
4.
Aggregate
Risk
...............................................
16
a.
Chronic
(Non
Cancer)
Aggregate
Risk
......................
17
b.
Short
term
Aggregate
Risk
................................
17
c.
Aggregate
Risk
for
Cancer
................................
17
5.
Occupational
Risk
............................................
18
a.
Toxicity
................................................
19
b.
Handler
Exposure
........................................
19
c.
Handler
(Non
cancer)
Risk
................................
21
d.
Handler
Cancer
Risk
.....................................
22
(1)
Post
Application
Occupational
Risk
....................
24
(2)
Data
Sources
.......................................
24
(3)
Assumptions
.......................................
25
e.
Reentry
Worker
(Non
cancer)
Risk
.........................
25
f.
Reentry
Worker
Cancer
Risk
..............................
25
6.
Human
Incident
Data
..........................................
26
B.
Environmental
Risk
Assessment
......................................
27
1.
Environmental
Fate
and
Transport
..............................
27
2.
Ecological
Risk
...............................................
28
3.
Risk
to
Terrestrial
Organisms
..................................
28
a.
Toxicity
(Hazard)
Assessment
..............................
28
b.
Exposure
and
Risk
....................................
29
4.
Uncertainties
in
Terrestrial
Risk
Assessment
......................
31
5.
Risk
to
Aquatic
Animals
.......................................
32
a.
Toxicity
(Hazard)
Assessment
..............................
32
b.
Exposure
and
Risk
.......................................
32
6.
Risk
to
Aquatic
Plants
.........................................
34
a.
Uncertainties
in
the
Aquatic
Assessment
.....................
34
7.
Endangered
Species
...........................................
35
8.
Ecological
Incidents
...........................................
37
IV.
Risk
Management
and
Reregistration
Decision
..............................
37
A.
Determination
of
Reregistration
Eligibility
.............................
37
B.
Public
Comments
and
Responses
.....................................
38
C.
Regulatory
Position
................................................
39
1.
FQPA
Assessment
.............................................
39
a.
"Risk
Cup"
Determination
................................
39
b.
Determination
of
Safety
for
U.
S.
Population
..................
40
c.
Determination
of
Safety
for
Infants
and
Children
.............
40
d.
Endocrine
Disruptor
Effects
...............................
41
e.
Cumulative
Risks
........................................
41
f.
Tolerances
Summary
.....................................
42
D.
Regulatory
Rationale
...............................................
46
1.
Human
Health
Risk
Management
...............................
46
a.
Dietary
(Food)
Risk
Mitigation
.............................
46
(1)
Chronic
Dietary
(Food)
..............................
46
(2)
Cancer
Dietary
(Food)
...............................
46
(3)
Drinking
Water
.....................................
47
(4)
Aggregate
Risk
Mitigation
(short
term,
chronic,
and
cancer)
..................................................
49
b.
Occupational
Risk
Mitigation
..............................
50
(1)
Handler
Risks
......................................
50
(2)
Post
application
Exposure
............................
51
2.
Environmental
Risk
Mitigation
.................................
53
a.
Risk
Characterization
....................................
53
(1)
Aquatic
Organisms
..................................
53
(2)
Terrestrial
Organisms
...............................
53
(3)
Endangered
Species
.................................
53
(4)
Mitigation
Measures
.................................
54
3.
Other
Label
Statements
........................................
54
a.
Endangered
Species
Statement
.............................
54
b.
Spray
Drift
Management
..................................
55
V.
What
Registrants
Need
to
Do
.............................................
56
A.
Manufacturing
Use
Products
........................................
57
1.
Additional
Generic
Data
Requirements
...........................
57
2.
Labeling
for
Manufacturing
Use
Products
........................
58
B.
End
Use
Products
..................................................
58
1.
Additional
Product
Specific
Data
Requirements
...................
58
2.
Labeling
for
End
Use
Products
..................................
59
C.
Existing
Stocks
....................................................
59
VI.
APPENDICES
...........................................................
66
Appendix
A:
Use
Patterns
Eligible
for
Reregistration
......................
67
Appendix
B:
Data
Supporting
the
Reregistration
of
Oxyfluorfen
............
89
Appendix
C:
Technical
Support
Documents
.............................
95
Appendix
D.
Citations
Considered
to
be
Part
of
the
Database
...............
96
Appendix
E.
Generic
Data
Call
In
....................................
127
Appendix
F.
Product
Specific
Data
Call
In
.............................
129
Appendix
G:
EPA'S
Batching
of
Oxyfluorfen
Products
for
Meeting
Acute
Toxicity
Data
Requirements
for
Reregistration
..............
131
Appendix
H.
List
of
Registrants
Sent
This
Data
Call
In
...................
134
Appendix
I.
List
of
Available
Related
Documents
and
Electronically
Available
Forms
.................................................
136
i
Oxyfluorfen
Team
Office
of
Pesticide
Programs:
Health
Effects
Risk
Assessment
Timothy
Dole
Kit
Farwell
Felecia
Fort
Jose
Morales
Environmental
Fate
Risk
Assessment
Amer
Al
Mudallal
Norman
Birchfield
Christine
Hartless
Use
and
Usage
Analysis
Jihad
Alsadek
Neil
Anderson
Registration
Support
Eugene
Wilson
Risk
Management
Deanna
Scher
John
Leahy
ii
GLOSSARY
OF
TERMS
AND
ABBREVIATIONS
AE
Acid
Equivalent
a.
i.
Active
Ingredient
AGDCI
Agricultural
Data
Call
In
ai
Active
Ingredient
aPAD
Acute
Population
Adjusted
Dose
AR
Anticipated
Residue
ARC
Anticipated
Residue
Contribution
BCF
Bioconcentration
Factor
CNS
Central
Nervous
System
cPAD
Chronic
Population
Adjusted
Dose
CSF
Confidential
Statement
of
Formula
CFR
Code
of
Federal
Regulations
CSFII
USDA
Continuing
Surveys
for
Food
Intake
by
Individuals
DCI
Data
Call
In
DEEM
Dietary
Exposure
Evaluation
Model
DFR
Dislodgeable
Foliar
Residue
DRES
Dietary
Risk
Evaluation
System
DWEL
Drinking
Water
Equivalent
Level
(DWEL)
The
DWEL
represents
a
medium
specific
(i.
e.,
drinking
water)
lifetime
exposure
at
which
adverse,
noncarcinogenic
health
effects
are
not
anticipated
to
occur.
DWLOC
Drinking
Water
Level
of
Comparison.
EC
Emulsifiable
Concentrate
Formulation
EEC
Estimated
Environmental
Concentration.
The
estimated
pesticide
concentration
in
an
environment,
such
as
a
terrestrial
ecosystem.
EP
End
Use
Product
EPA
U.
S.
Environmental
Protection
Agency
FAO
Food
and
Agriculture
Organization
FDA
Food
and
Drug
Administration
FIFRA
Federal
Insecticide,
Fungicide,
and
Rodenticide
Act
FFDCA
Federal
Food,
Drug,
and
Cosmetic
Act
FQPA
Food
Quality
Protection
Act
FOB
Functional
Observation
Battery
G
Granular
Formulation
GENEEC
Tier
I
Surface
Water
Computer
Model
GLC
Gas
Liquid
Chromatography
GLN
Guideline
Number
GM
Geometric
Mean
GRAS
Generally
Recognized
as
Safe
as
Designated
by
FDA
HA
Health
Advisory
(HA).
The
HA
values
are
used
as
informal
guidance
to
municipalities
and
other
organizations
when
emergency
spills
or
contamination
situations
occur.
HAFT
Highest
Average
Field
Trial
HDT
Highest
Dose
Tested
IR
Index
Reservoir
LC50
Median
Lethal
Concentration.
A
statistically
derived
concentration
of
a
substance
that
can
be
expected
to
cause
death
in
50%
of
test
animals.
It
is
usually
expressed
as
the
weight
of
substance
per
weight
or
volume
of
water,
air
or
feed,
e.
g.,
mg/
l,
mg/
kg
or
ppm.
LD50
Median
Lethal
Dose.
A
statistically
derived
single
dose
that
can
be
expected
to
cause
death
in
50%
of
the
test
animals
when
administered
by
the
route
indicated
(oral,
dermal,
inhalation).
It
is
expressed
as
a
weight
of
substance
per
unit
weight
of
animal,
e.
g.,
mg/
kg.
LEL
Lowest
Effect
Level
LOC
Level
of
Concern
iii
LOD
Limit
of
Detection
LOAEL
Lowest
Observed
Adverse
Effect
Level
MATC
Maximum
Acceptable
Toxicant
Concentration
MCLG
Maximum
Contaminant
Level
Goal
(MCLG)
The
MCLG
is
used
by
the
Agency
to
regulate
contaminants
in
drinking
water
under
the
Safe
Drinking
Water
Act.
mg/
kg/
day
Milligram
Per
Kilogram
Per
Day
mg/
L
Milligrams
Per
Liter
MOE
Margin
of
Exposure
MP
Manufacturing
Use
Product
MPI
Maximum
Permissible
Intake
MRID
Master
Record
Identification
(number).
EPA's
system
of
recording
and
tracking
studies
submitted.
NA
Not
Applicable
N/
A
Not
Applicable
NAWQA
USGS
National
Water
Quality
Assessment
NOEC
No
Observable
Effect
Concentration
NOEL
No
Observed
Effect
Level
NOAEL
No
Observed
Adverse
Effect
Level
NPDES
National
Pollutant
Discharge
Elimination
System
NR
Not
Required
OP
Organophosphate
OPP
EPA
Office
of
Pesticide
Programs
OPPTS
EPA
Office
of
Prevention,
Pesticides
and
Toxic
Substances
Pa
pascal,
the
pressure
exerted
by
a
force
of
one
newton
acting
on
an
area
of
one
square
meter.
PAD
Population
Adjusted
Dose
PADI
Provisional
Acceptable
Daily
Intake
PAG
Pesticide
Assessment
Guideline
PAM
Pesticide
Analytical
Method
PCA
Percent
Crop
Area
PDP
USDA
Pesticide
Data
Program
PHED
Pesticide
Handler's
Exposure
Data
PHI
Preharvest
Interval
ppb
Parts
Per
Billion
PPE
Personal
Protective
Equipment
ppm
Parts
Per
Million
PRN
Pesticide
Registration
Notice
PRZM/
EXAMS
Tier
II
Surface
Water
Computer
Model
Q1*
The
Carcinogenic
Potential
of
a
Compound,
Quantified
by
the
EPA's
Cancer
Risk
Model
RAC
Raw
Agriculture
Commodity
RED
Reregistration
Eligibility
Decision
REI
Restricted
Entry
Interval
RfD
Reference
Dose
RQ
Risk
Quotient
RS
Registration
Standard
RUP
Restricted
Use
Pesticide
SAP
Science
Advisory
Panel
SCI
GROW
Tier
I
Ground
Water
Computer
Model
SF
Safety
Factor
SLC
Single
Layer
Clothing
SLN
Special
Local
Need
(Registrations
Under
Section
24(
c)
of
FIFRA)
TC
Toxic
Concentration.
The
concentration
at
which
a
substance
produces
a
toxic
effect.
TD
Toxic
Dose.
The
dose
at
which
a
substance
produces
a
toxic
effect.
TEP
Typical
End
Use
Product
iv
TGAI
Technical
Grade
Active
Ingredient
TLC
Thin
Layer
Chromatography
torr
A
unit
of
pressure
needed
to
support
a
column
of
mercury
1
mm
high
under
standard
conditions.
TRR
Total
Radioactive
Residue
UF
Uncertainty
Factor
µg/
g
Micrograms
Per
Gram
µg/
L
Micrograms
Per
Liter
USDA
United
States
Department
of
Agriculture
USGS
United
States
Geological
Survey
UV
Ultraviolet
WHO
World
Health
Organization
WP
Wettable
Powder
WPS
Worker
Protection
Standard
v
Executive
Summary
EPA
has
completed
its
review
of
public
comments
on
the
preliminary
risk
assessments
and
is
issuing
its
risk
management
decision
for
oxyfluorfen.
The
revised
risk
assessments
are
based
on
review
of
the
required
target
data
base
supporting
the
use
patterns
of
currently
registered
products
and
additional
information
received.
After
considering
the
risks
identified
in
the
revised
risk
assessment
and
comments
and
mitigation
suggestions
from
interested
parties,
EPA
developed
its
risk
management
decision
for
uses
of
oxyfluorfen
that
pose
risks
of
concern.
This
decision
is
discussed
fully
in
this
document.
Oxyfluorfen
is
a
broad
spectrum
pre
and
postemergent
herbicide
used
on
a
variety
of
tree
and
vine
crops,
selected
annual
and
perennial
crops,
as
well
as
fallow
bed
and
non
crop
uses
(e.
g.
roadsides),
to
control
annual
broadleaf
and
grassy
weeds.
Residential
homeowners
may
use
oxyfluorfen
products
for
spot
treatment
of
weeds.
It
was
first
registered
in
1979.
Approximately
761,000
pounds
of
oxyfluorfen
active
ingredient
are
applied
annually.
Sites
on
which
oxyfluorfen
has
the
highest
percent
of
crop
treated
include
wine
grapes,
almonds,
cotton,
walnuts,
and
table
grapes.
The
Food
Quality
Protection
Act
(FQPA)
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."
Oxyfluorfen
is
structurally
related
to
other
diphenyl
ethers
including
lactofen,
acifluorfen,
and
fomesafen.
The
Agency
has
not
determined
whether
or
not
oxyfluorfen
shares
a
common
mechanism
of
toxicity
with
these
pesticides
or
any
other
pesticide.
As
a
result,
the
Agency
has
not
determined
if
it
would
be
appropriate
to
include
them
in
a
cumulative
risk
assessment.
After
a
decision
is
made
regarding
common
mechanism
of
toxicity,
and
if
the
Agency
has
determined
that
a
cumulative
assessment
is
necessary,
the
Agency
will
address
any
outstanding
concerns
at
that
time.
Overall
Risk
Summary
Acute
risks
were
not
evaluated
for
oxyfluorfen
because
adverse
effects
reflecting
a
single
dose
were
not
identified
in
toxicological
studies
at
the
highest
dose
tested.
EPA's
human
health
risk
assessment
for
oxyfluorfen
indicates
that
chronic
food
risk
is
not
of
concern
(<
1%
of
cPAD).
Oxyfluorfen
is
classified
in
group
C
(possible
human
carcinogen)
based
on
combined
hepatocellular
adenomas/
carcinomas
in
the
mouse
carcinogenicity
study.
The
cancer
dietary
risk
from
food
alone
is
3.8
x
10
7
for
the
general
U.
S.
population,
and
is
not
a
concern
for
the
Agency
(<
1
x
10
6
).
The
drinking
water
risk
estimates
for
chronic
(non
cancer)
exposures
are
below
EPA's
level
of
concern
for
ground
or
surface
waters.
However,
cancer
risk
estimates
from
modeling
for
surface
water
sources
of
drinking
water
indicate
a
concern
based
on
conservative
assumptions
for
model
inputs.
Residential
risks
are
below
EPA's
level
of
concern,
however,
there
is
a
concern
for
aggregate
risk
when
considering
exposures
from
food,
drinking
water,
and
residential
uses.
There
are
cancer
risk
concerns
for
workers
who
mix,
load,
and
apply
oxyfluorfen
to
agricultural
sites,
as
well
as
workers
who
re
enter
treated
sites.
Finally,
vi
EPA
has
identified
risks
of
concern
to
plant
and
aquatic
species
and
chronic
concerns
to
birds
and
mammals.
To
mitigate
risks
of
concern
posed
by
the
uses
of
oxyfluorfen,
EPA
considered
the
comments
and
mitigation
ideas
from
interested
parties,
and
has
decided
on
a
number
of
label
amendments
to
address
the
drinking
water,
aggregate,
worker,
and
ecological
concerns.
Results
of
the
risk
assessments,
and
required
label
amendments
to
mitigate
those
risks,
are
presented
in
this
RED.
Dietary
Risk
–
Food
No
adverse
effects
reflecting
a
single
dose
were
identified
in
toxicological
studies;
therefore,
no
acute
endpoint
was
selected
and
an
acute
dietary
risk
assessment
was
not
conducted.
EPA's
dietary
risk
analysis
for
oxyfluorfen
evaluated
chronic
(non
cancer)
and
cancer
risk.
For
these
chronic
food
risk
assessments,
anticipated
residues
were
calculated
using
either
USDA
Pesticide
Data
Program
(PDP)
monitoring
data
or
field
trial
data.
Both
data
sets
are
consistent
in
that
they
show
all
non
detectable
residues.
Based
on
this
analysis,
the
percentage
of
cPAD
utilized
is
expected
to
be
less
than
1
percent
for
the
U.
S.
population
and
all
subpopulations.
Therefore,
the
chronic
(non
cancer)
dietary
risk
estimate
from
food
alone
is
not
of
concern.
Cancer
risk
from
food
is
calculated
by
using
a
linear
low
dose
risk
model
("
Q1*")
to
determine
the
lifetime
cancer
risk
estimate.
The
Agency
generally
considers
risks
greater
than
1
x
10
6
(1
in
1
million)
to
exceed
its
level
of
concern
for
cancer
dietary
exposure.
Using
the
Q1*
of
7.32
x
10
2
results
in
a
maximum
estimated
lifetime
cancer
risk
to
the
U.
S.
general
population
of
3.8
x
10
7
.
Therefore,
the
cancer
risk
from
food
alone
is
also
not
of
concern.
Dietary
Risk
–
Drinking
Water
Drinking
water
exposure
to
pesticides
can
occur
through
groundwater
and
surface
water
contamination.
For
oxyfluorfen,
EPA
considered
chronic
(lifetime)
drinking
water
risk
and
used
modeling
to
estimate
those
risks.
To
determine
the
maximum
allowable
contribution
from
water
allowed
in
the
diet,
EPA
first
looks
at
how
much
of
the
overall
allowable
risk
is
contributed
by
food
and
then
determines
a
"drinking
water
level
of
comparison"
(DWLOC)
to
determine
whether
modeled
or
monitoring
estimated
environmental
concentration
(EEC)
levels
exceed
this
level.
EECs
that
are
above
the
corresponding
DWLOC
exceed
the
Agency's
level
of
concern.
Since
the
chronic
EECs
for
surface
water
and
groundwater
are
less
than
the
lowest
DWLOC,
chronic
non
cancer
dietary
risk
from
food
and
drinking
water
is
not
of
concern.
However,
modeling
does
indicate
a
possible
concern
for
cancer
risk,
as
the
EEC
in
surface
water
exceeds
the
cancer
DWLOC.
To
address
surface
water
concerns,
the
technical
registrants
have
agreed
to
implement
measures
to
reduce
the
potential
for
oxyfluorfen
to
reach
surface
water,
including
a
reduction
in
maximum
seasonal
rates
and
implementation
of
vegetative
buffers
between
treated
areas
and
natural
water
bodies.
Actual
drinking
water
exposure
to
oxyfluorfen
vii
from
surface
water
sources
is
expected
to
be
less
than
the
DWLOCs
and
the
registrants
have
also
agreed
to
conduct
an
edge
of
field
monitoring
study
to
confirm
that
drinking
water
exposure
will
not
exceed
the
level
of
concern.
Residential
Risk
Oxyfluorfen
is
used
in
the
residential
environment
by
homeowners
to
kill
weeds
on
patios,
driveways
and
similar
surfaces.
Oxyfluorfen
homeowner
products
are
intended
solely
for
spot
treatment;
they
are
not
used
for
broadcast
treatment
of
lawns
because
they
kill
grass.
The
residential
assessment
for
oxyfluorfen
only
addresses
the
applicator,
because
negligible
postapplication
exposure
is
anticipated
from
spot
treatment
of
weeds.
None
of
the
residential
applicator
scenarios
are
of
concern
because
the
short
term
MOEs
are
greater
than
100
and
the
cancer
risks
are
less
than
1.0
x
10
6
.
Aggregate
Risk
An
aggregate
risk
assessment
looks
at
the
combined
risk
from
dietary
exposure
(food
and
drinking
water
pathways)
as
well
as
exposures
from
non
occupational
sources
(e.
g.,
residential
uses).
Generally,
all
risks
from
these
exposures
must
have
MOEs
greater
than
100
to
not
be
of
concern
to
the
Agency.
Chronic
(Non
cancer)
Aggregate
Risk.
The
chronic
(non
cancer)
aggregate
risk
assessment
addresses
exposure
to
oxyfluorfen
residues
in
food
and
water
only,
as
there
are
no
chronic
residential
scenarios
identified.
As
discussed
previously,
comparison
of
the
chronic
DWLOCs
with
the
environmental
concentrations
of
oxyfluorfen
shows
that
estimated
surface
and
groundwater
concentrations
are
substantially
less
than
the
DWLOCs
for
all
populations.
Consequently,
the
Agency
concludes
that
residues
of
oxyfluorfen
in
food
and
drinking
water
do
not
result
in
a
chronic
aggregate
risk
of
concern.
Short
term
Aggregate
Risk.
Short
term
DWLOCs
were
calculated
based
upon
average
food
residues,
and
the
residential
handler
exposure
which
resulted
in
the
greatest
risk
(spot
treatment
of
weeds
using
a
RTU
trigger
pump
sprayer).
DWLOC
calculations
are
for
adults
only
since
the
residential
exposure
is
to
applicators.
Surface
and
ground
water
concentrations
estimated
using
conservative
modeling
are
less
than
the
short
term
DWLOCs
for
oxyfluorfen.
Consequently,
there
is
no
short
term
aggregate
risk
concerns
from
food,
drinking
water
and
residential
exposures.
Cancer
Aggregate
Risk.
The
chronic
food
cancer
risk
estimate
of
3.8
x
10
7
,
combined
with
the
highest
residential
cancer
risk
estimate
of
8.7
x
10
7
,
results
in
a
food
+
residential
cancer
risk
of
1.3
x
10
6
.
Since
the
Agency's
level
of
concern
is
1.0
x
10
6
,
cancer
risk
slightly
exceeds
EPA's
level
of
concern
when
considering
both
food
and
residential
exposures.
However,
since
PDP
monitoring
and
field
trial
data
showed
all
residues
on
food
were
non
detects,
the
food
risk
estimate
is
considered
upper
bound.
Screening
level
surface
water
modeling
indicates
that
there
viii
may
be
a
concern
for
oxyfluorfen
in
drinking
water,
but
this
water
modeling
is
also
considered
upper
bound.
Occupational
Risk
Cancer
risk
to
workers
is
of
greater
concern
than
non
cancer
risk.
Occupational
cancer
risks,
when
calculated
without
personal
protective
equipment
or
engineering
controls,
can
range
up
to
1
x
10
3
.
With
the
protection
specified
on
several
current
labels,
most
scenarios
result
in
cancer
risks
in
the
10
5
range.
EPA
believes
these
risks
can
be
mitigated
to
an
acceptable
level
with
the
following
label
restrictions:
(1)
requiring
additional
personal
protective
equipment
or
engineering
controls
for
certain
scenarios,
and
(2)
increasing
restricted
entry
intervals
for
certain
uses.
Ecological
Risk
Ecological
risks
are
of
concern
to
the
Agency.
Based
on
toxicity
studies
submitted
by
the
registrant,
oxyfluorfen
has
the
potential
to
result
in
adverse
effects
to
birds,
mammals,
aquatic
organisms
and
plants.
To
address
these
ecological
risks,
the
registrants
have
agreed
to
decrease
seasonal
maximum
rates
for
certain
crops,
add
label
statements
prohibiting
application
of
oxyfluorfen
within
25
feet
of
aquatic
areas,
and
require
coarse
droplet
size
for
all
spray
applications.
The
registrants
will
also
conduct
additional
ecological
effects
and
environmental
fate
studies
to
better
characterize
exposure
to
non
target
species.
Conclusions
The
Agency
is
issuing
this
Reregistration
Eligibility
Document
(RED)
for
oxyfluorfen,
as
announced
in
a
Notice
of
Availability
published
in
the
Federal
Register.
This
RED
document
includes
guidance
and
time
frames
for
complying
with
any
required
label
changes
for
products
containing
oxyfluorfen.
With
the
addition
of
the
label
restrictions
and
amendments
detailed
in
this
document,
the
Agency
has
determined
that
all
currently
registered
uses
of
oxyfluorfen
are
eligible
for
reregistration.
The
risk
assessments
for
oxyfluorfen
are
based
on
the
best
scientific
data
currently
available
to
the
Agency
and
are
adequate
for
regulatory
decision
making.
Registrants
have
committed
to
provide
additional
data
that
may
remove
some
of
the
uncertainties
associated
with
exposures
and
risks
posed
by
oxyfluorfen,
including
studies
to
define
the
cancer
mechanism
and
efficacy
studies
to
determine
an
appropriate
rate
for
residential
uses.
If
data
are
provided
which
enable
EPA
to
refine
the
exposure
or
risk
conclusions
presented
in
this
document,
EPA
will
evaluate
the
risk
mitigation
measures
identified
above,
and
if
appropriate,
will
amend
this
RED
to
reflect
any
new
risk
conclusions.
There
is
a
60
day
public
comment
period
for
this
document.
1
I.
Introduction
The
Federal
Insecticide,
Fungicide,
and
Rodenticide
Act
(FIFRA)
was
amended
in
1988
to
accelerate
the
reregistration
of
products
with
active
ingredients
registered
prior
to
November
1,
1984.
The
amended
Act
calls
for
the
development
and
submission
of
data
to
support
the
reregistration
of
an
active
ingredient,
as
well
as
a
review
of
all
submitted
data
by
the
U.
S.
Environmental
Protection
Agency
(referred
to
as
EPA
or
"the
Agency").
Reregistration
involves
a
thorough
review
of
the
scientific
database
underlying
a
pesticide's
registration.
The
purpose
of
the
Agency's
review
is
to
reassess
the
potential
hazards
arising
from
the
currently
registered
uses
of
the
pesticide;
to
determine
the
need
for
additional
data
on
health
and
environmental
effects;
and
to
determine
whether
the
pesticide
meets
the
"no
unreasonable
adverse
effects"
criteria
of
FIFRA.
On
August
3,
1996,
the
Food
Quality
Protection
Act
of
1996
(FQPA)
was
signed
into
law.
This
Act
amends
FIFRA
to
require
tolerance
reassessment
during
reregistration.
It
also
requires
that
by
2006,
EPA
must
review
all
tolerances
in
effect
on
the
day
before
the
date
of
the
enactment
of
the
FQPA,
which
was
August
3,
1996.
FQPA
also
amends
the
FFDCA
to
require
a
safety
finding
in
tolerance
reassessment
based
on
factors
including
an
assessment
of
cumulative
effects
of
chemicals
with
a
common
mechanism
of
toxicity.
Oxyfluorfen
is
a
diphenyl
ether
herbicide
structurally
related
to
lactofen,
fomesafen
and
acifluorfen.
At
this
time,
the
Agency
has
not
made
a
decision
as
to
whether
oxyfluorfen
shares
a
common
mechanism
of
toxicity
with
these
other
diphenyl
ethers
or
any
other
pesticide.
A
careful
evaluation
of
all
the
available
data
is
still
needed,
as
well
as
peer
review
by
the
FIFRA
Science
Advisory
Panel,
before
a
formal
decision
is
made.
Therefore,
for
the
purposes
of
this
risk
assessment,
the
Agency
has
assumed
that
oxyfluorfen
does
not
share
a
common
mechanism
of
toxicity
with
other
pesticides.
After
a
decision
is
made
regarding
common
mechanism
of
toxicity,
and
if
the
Agency
has
determined
that
a
cumulative
assessment
is
necessary,
the
Agency
will
address
any
outstanding
risk
concerns
at
that
time.
The
implementation
of
FQPA
has
required
the
Agency
to
revisit
some
of
its
existing
policies
relating
to
the
determination
and
regulation
of
dietary
risk,
and
has
also
raised
a
number
of
new
issues
for
which
policies
need
to
be
created.
These
issues
were
refined
and
developed
through
collaboration
between
the
Agency
and
the
Tolerance
Reassessment
Advisory
Committee
(TRAC),
which
was
composed
of
representatives
from
industry,
environmental
groups,
and
other
interested
parties.
The
TRAC
identified
the
following
science
policy
issues
it
believed
were
key
to
the
implementation
of
FQPA
and
tolerance
reassessment:
°
Applying
the
FQPA
10
fold
safety
factor
°
Whether
and
how
to
use
probabilistic
analyses
in
dietary
exposure
assessments
°
How
to
interpret
"no
detectable
residues"
in
dietary
exposure
assessments
°
Refining
dietary
(food)
exposure
estimates
°
Refining
dietary
(drinking
water)
exposure
estimates
°
Assessing
residential
exposure
2
°
Aggregating
exposure
from
all
non
occupational
sources
°
How
to
conduct
a
cumulative
risk
assessment
for
organophosphate
or
other
pesticides
with
a
common
mechanism
of
toxicity
°
Selection
of
appropriate
toxicity
endpoints
for
risk
assessments
of
organophosphates
°
Whether
and
how
to
use
data
derived
from
human
studies
The
process
developed
by
the
TRAC
calls
for
EPA
to
provide
one
or
more
documents
for
public
comment
on
each
of
the
policy
issues
described
above.
Each
of
these
issues
is
evolving
and
in
a
different
stage
of
refinement.
Some
issue
papers
have
already
been
published
for
comment
in
the
Federal
Register
and
others
will
be
published
shortly.
This
document
consists
of
six
sections.
Section
I
contains
the
regulatory
framework
for
reregistration/
tolerance
reassessment.
Section
II
provides
a
profile
of
the
use
and
usage
of
the
chemical.
Section
III
gives
an
overview
of
the
revised
human
health
and
environmental
effects
risk
assessments
resulting
from
public
comments
and
other
information.
Section
IV
presents
the
Agency's
reregistration
eligibility
and
risk
management
decisions.
Section
V
summarizes
required
label
changes
based
on
the
risk
mitigation
measures
outlined
in
Section
IV.
Section
VI
provides
information
on
how
to
access
related
documents.
Finally,
the
Appendices
list
Data
Call
In
(DCI)
information.
The
revised
risk
assessments
and
related
addenda
are
not
included
in
this
document,
but
are
available
on
the
Agency's
web
page
www.
epa.
gov/
pesticides,
and
in
the
Public
Docket.
II.
Chemical
Overview
A.
Regulatory
History
Oxyfluorfen
was
first
registered
in
the
United
States
in
1979
to
control
pre
emergent
and
post
emergent
broadleaf
and
grassy
weeds
in
the
culture
of
a
variety
of
field,
fruit,
and
vegetable
crops,
ornamentals,
as
well
as
non
crop
sites.
It
is
manufactured
by
Dow
AgroSciences
and
Makhteshim
Agan
under
the
trade
names
Goal
and
Galigan.
Data
call
ins
were
issued
in
1991,
1993,
and
1995.
In
an
effort
to
promote
transparency
of
the
reregistration
process
and
public
understanding
of
regulatory
decisions,
the
Agency,
in
cooperation
with
the
U.
S.
Department
of
Agriculture
(USDA)
modified
the
reregistration
and
tolerance
reassessment
process
in
1998.
This
modified
process
provides
opportunities
for
stakeholders
to
ask
questions
about
and
provide
input
to
the
risk
assessment
and
risk
mitigation
strategies,
via
conference
calls
and
other
formats.
Consistent
with
this
process,
the
January
2002
risk
assessments
were
made
publicly
available
for
comment
and
a
close
out
conference
call
was
conducted
on
July
25,
2002
to
discuss
the
risk
management
decisions
and
resultant
changes
to
the
oxyfluorfen
labels.
3
O
Cl
F
3
C
NO
2
O
CH
3
B.
Chemical
Identification
°
Common
Name:
Oxyfluorfen
°
Chemical
Name:
2
chloro
1(
3
ethoxy
4
nitrophenoxy)
4
(trifluoromethyl)
benzene
°
Chemical
family:
Diphenyl
ether
herbicide
°
Case
number:
2490
°
CAS
registry
number:
42874
03
3
°
OPP
chemical
code:
111601
°
Empirical
formula:
C15H11ClF3NO4
°
Molecular
weight:
361.72
g/
mole
°
Trade
and
other
names:
Goal,
Galigan
°
Basic
manufacturer:
Dow
AgroSciences
Oxyfluorfen
is
an
orange
to
deep
red
brown
crystalline
solid
with
a
melting
point
of
65
84
°C,
density
of
1.49
g/
mL,
octanol/
water
partition
coefficient
of
>20,
and
vapor
pressure
of
2.5
x
10
7
Torr
at
25°
C.
Oxyfluorfen
is
practically
insoluble
in
water
(0.1
ppm),
but
is
readily
soluble
in
most
organic
solvents.
C.
Use
Profile
The
following
information
is
based
on
the
currently
registered
uses
of
oxyfluorfen:
Type
of
Pesticide:
Contact
herbicide
used
for
pre
or
post
emergence
control
of
monocotyledenous
and
broad
leaved
weeds.
4
Mode
of
Action:
Oxyfluorfen
targets
a
specific
enzyme,
protoporphyrinogen
oxidase,
in
the
chlorophyll
biosynthetic
pathway.
Inhibiting
protoporphyringen
oxidase
in
plants
leads
to
an
accumulation
of
phototoxic
chlorophyll
precursors
which,
in
the
presence
of
light,
produce
activated
oxygen
species
which
rapidly
disrupt
cell
membrane
integrity.
Oxyfluorfen
must
contact
plant
foliage
to
cause
effects.
Plants
that
are
actively
growing
are
most
susceptible
to
oxyfluorfen.
By
forming
a
chemical
barrier
on
the
soil
surface,
oxyfluorfen
affects
plants
at
emergence.
This
barrier
is
formed
with
adequate
spray
coverage
or
irrigation
following
granule
application
(to
partially
dissolve
granules
and
promote
dispersion
of
oxyfluorfen
over
the
soil
surface).
Because
of
the
length
of
oxyfluorfen
soil
half
life,
this
barrier
may
last
up
to
three
months.
All
plants
attempting
to
emerge
through
the
soil
surface
will
be
affected
through
contact.
Oxyfluorfen
also
affects
plants
through
direct
contact
of
spray
or
granules
to
exposed
tissues.
Summary
of
Use
Sites:
Food:
Treefruit/
Nut/
Vine
Crops:
Almonds,
apple,
apricot,
avocado,
banana,
beechnut,
brazil
nut,
butternut,
cashew,
cherry,
chestnut,
chinquapin,
citrus
(non
bearing),
crab
apple,
dates,
feijoa,
fig,
filbert,
grapes,
hickory
nut,
kiwi,
loquat,
macadamia
nut,
mango,
mayhaw,
nectarine,
olives,
papaya,
peach,
pear,
pecan,
persimmon,
pistachio,
plum,
pomegranates,
prune,
quince,
and
walnut.
Field
Crops:
Artichokes
(globe),
blackberries,
broccoli,
cabbage,
cacao,
cauliflower,
clary
sage,
clover,
coffee,
corn,
cotton,
garbanzo
beans,
garlic,
guava,
horseradish,
jojoba,
mint,
onions,
raspberries,
soybeans
and
taro.
Fallow
Bed:
Broccoli,
cabbage,
cauliflower,
cotton,
garlic,
grapes,
kiwi,
onion,
potato,
soybeans,
tree
fruit/
nut/
citrus,
dry
beans.
Fallow
Bed
(non
food,
no
tolerance):
Cantaloupe,
carrot,
cereal
grains,
celery,
conifers,
dry
beans,
peanut
(other
legumes),
pepper,
safflower,
squash,
strawberries,
sugarbeet
(other
root/
tuber
crops),
tomato
(other
fruiting
vegetables),
watermelon
(other
cucurbits).
Non
food
Uses:
Ornamental
plants/
trees/
shrubs,
conifer
seed
beds
and
transplants,
cut
flowers,
forest
trees,
Christmas
tree
plantations,
rights
of
way/
fencerows
and
non
crop
areas
(nonagricultural
uncultivated
areas,
roadsides,
industrial
areas,
storage
yards,
non
grazed
meadows
and
farmsteads.)
5
Residential
Uses:
Landscape,
curbs/
gutters,
patios,
brick
walls,
sidewalks/
walkways
and
driveways.
Formulation
Types
Registered:
Oxyfluorfen
is
formulated
for
agricultural
uses
as
an
emulsifiable
liquid
concentrate
containing
0.2
to
4
pounds
active
ingredient
(ai)
per
gallon
and
as
a
granular
product
containing
2%
oxyfluorfen
by
weight.
Oxyfluorfen
is
most
frequently
used
in
a
liquid
formulation
for
food
crops
and
as
a
granular
formulation
for
ornamental
nursery
crops.
There
are
also
several
ready
to
use
products
and
a
liquid
concentrate
available
for
residential
use.
Residential
formulations
contain
0.25%
to
0.70%
oxyfluorfen
by
volume
and
are
packaged
in
a
ready
to
use
(RTU)
sprinkler
jug,
a
RTU
trigger
sprayer
or
as
a
liquid
to
be
mixed
in
a
sprinkler
can
or
tank
sprayer.
Application
Methods
and
Equipment:
Agricultural
liquid
formulations
of
oxyfluorfen
are
applied
using
large,
small
or
ATV
groundboom
rigs.
Aerial
application
is
used
mainly
for
fallow
fields
and
bulb
vegetables.
Backpack
sprayers
can
be
used
in
Christmas
tree
plantations
and
right
of
way
areas.
Chemigation
is
used
for
over
the
top
application
to
bulb
vegetables
and
for
drip
application
to
some
orchard
trees,
however,
chemigation
is
often
prohibited
per
the
product
labels.
Right
of
way
sprayers
are
used
in
right
of
way
areas.
Granular
oxyfluorfen
is
applied
to
field
and
container
grown
ornamentals
with
broadcast
spreaders.
Application
Rates
and
Frequency:
0.25
2.0
lbs
ai/
acre/
application.
Typically
one
or
two
applications
are
made
in
the
growing
season
to
prevent
weed
growth
(pre
emergent)
and/
or
to
kill
small
weeds
(post
emergent).
Some
crops
allow
a
greater
number
of
applications/
season,
including
tropical
commodities
(e.
g.
guava,
coffee,
macadamia
nut)
in
Hawaii
and
ornamentals.
Use
Classification:
General
use
pesticide
D.
Estimated
Usage
of
Pesticide
A
full
listing
of
all
uses
of
oxyfluorfen,
with
the
corresponding
use
and
usage
data
for
each
site,
has
been
completed
and
is
in
the
"Quantitative
Use
Analysis"
document,
which
is
available
in
the
public
docket.
The
data,
reported
on
an
aggregate
and
site
(crop)
basis,
reflect
annual
fluctuations
in
use
patterns
as
well
as
the
variability
in
using
data
from
various
information
sources.
Based
on
available
pesticide
survey
usage
information
for
the
years
1990
through
1999,
an
annual
estimate
of
oxyfluorfen's
total
domestic
usage
averaged
approximately
761,000
pounds
a..
i.
for
1,167,000
acres
treated.
Use
of
oxyfluorfen
is
increasing.
From
1992
to
1997
the
use
of
oxyfluorfen
increased
by
54%,
from
an
estimated
458,000
pounds
active
ingredient
in
1992
to
an
estimated
705,000
lbs
active
ingredient
in
1997.
The
largest
markets
in
terms
of
total
pounds
active
ingredient
are
wine
grapes
(32%),
almonds
(23%),
cotton
(7%),
walnuts
(6%),
and
table
grapes
(4%).
The
remaining
usage
is
primarily
on
apples,
corn,
raisin
grapes,
mint,
dry
6
onion,
ornamentals,
peaches,
pistachios,
prunes,
and
artichokes.
Crops
with
a
high
percentage
of
the
total
U.
S.
planted
acres
treated
include
wine
grapes
(54%),
artichokes
(53%),
pistachios
(44%),
almonds
(43%),
table
grapes
and
nectarines
(35%
each),
and
figs
(33%).
Most
of
the
usage
is
in
CA,
OR,
WA
and
the
cotton
growing
regions
along
the
Mississippi
River.
Table
1.
Oxyfluorfen
Estimated
Usage
for
Representative
Sites
1
Crop
Lbs.
Active
Ingredient
Applied
(Wt.
Avg.)
2
Percent
Crop
Treated
(Wt.
Avg.)
Percent
Crop
Treated
(Likely
Maximum)
Almonds
170,000
43%
86%
Artichokes
4,
000
53%
78%
Blackberries
1,000
18%
29%
Corn
7,000
.02%
0.1%
Cotton
54,000
1%
3%
Figs
3,000
33%
69%
Table
grapes
30,000
35%
61%
Wine
grapes
240,000
54%
84%
Kiwifruit
1,000
9%
29%
Mint
10,000
18%
26%
Nectarines
5,000
35%
61%
Olives
5,000
13%
21%
Onions,
dry
15,000
29%
57%
Peaches
24,000
14%
23%
Pistachios
26,000
44%
76%
Plums
6,
000
24%
52%
Pomegranates
1,000
26%
54%
Raspberries
1,000
28%
56%
Walnuts
48,000
28%
42%
Total
non
agricultural
(pasture,
ornamentals,
right
of
way,
rangeland,
etc.)
41,000
N/
A
N/
A
1
Uses
with
more
than
5,000
lbs
applied
(weighted
average)
and/
or
over
20%
crop
treated
were
selected
as
representative
sites.
2
Weighted
Average
is
based
on
data
for
1990
through
1999;
the
most
recent
years
and
more
reliable
data
are
weighted
more
heavily.
III.
Summary
of
Oxyfluorfen
Risk
Assessment
Following
is
a
summary
of
EPA's
revised
human
health
and
ecological
risk
findings
and
conclusions
for
the
herbicide
oxyfluorfen,
as
fully
presented
in
the
documents,
"Oxyfluorfen.
Revised
Human
Health
Risk
Assessment"
dated
April
29,
2002,
and
"Environmental
Fate
and
Effects
Division
Science
Chapter
for
Reregistration
Eligibility
Document
for
Oxyfluorfen,"
dated
May
2,
2002.
The
purpose
of
this
summary
is
to
assist
readers
by
identifying
the
key
7
features
and
findings
of
these
risk
assessments,
so
that
they
may
better
understand
the
conclusions
reached
in
the
assessments.
The
original
risk
assessments
for
oxyfluorfen
were
made
available
in
the
public
docket
and
on
the
Internet
on
January
30,
2002.
The
Agency
reviewed
and
addressed
all
comments
on
the
risk
assessment
documents.
There
is
a
discussion
of
these
comments
in
Section
IV,
later
in
this
document.
A.
Human
Health
Risk
Assessment
In
response
to
comments
and
studies
submitted,
the
risk
assessments
were
updated
and
refined.
The
conclusions
of
the
risk
assessment
are
summarized
below.
1.
Dietary
Risk
from
Food
a.
Toxicity
The
Agency
has
reviewed
all
toxicity
studies
submitted
and
has
determined
that
the
toxicity
database
is
sufficiently
complete,
and
that
it
supports
a
reregistration
eligibility
determination
for
all
currently
registered
uses.
The
Agency
Metabolism
Assessment
Review
Committee
has
concluded
that
the
residue
of
concern
in
plants
and
animals
is
oxyfluorfen
per
se
and
not
its
metabolites
or
degradate
products.
It
should
be
noted
that
older
toxicity
studies
with
oxyfluorfen
used
technical
material
of
approximately
71%
or
85%
purity.
The
newer
toxicity
studies
used
a
technical
material
of
approximately
98%
purity,
which
is
the
basis
for
the
current
registrations
of
oxyfluorfen.
The
newer
technical
material
has
similar
impurities
to
the
older
technical
material,
but
in
reduced
concentrations.
Toxicity
was
less
severe
for
studies
with
the
98%
product
than
for
the
71%
product;
however,
one
mammal
developmental
study
with
the
98%
technical
was
submitted
in
which
animals
experienced
the
most
severe
anemia
and
related
hematologic
effects
of
any
of
the
mammalian
studies.
When
there
were
studies
with
both
the
new
and
old
technical
material,
preference
for
an
endpoint
for
risk
assessment
purposes
was
generally
given
to
the
newer,
98%
technical
material
(current
registrations).
Oxyfluorfen
is
of
low
acute
toxicity
and
is
in
toxicity
category
IV
for
acute
oral,
dermal,
and
inhalation
toxicity.
It
is
a
slight
eye
and
dermal
irritant
and
is
not
a
dermal
sensitizer.
Toxicity
was
similar
for
subchronic
and
chronic
rat,
mouse,
and
dog
studies
in
both
sexes.
Oxyfluorfen
inhibits
heme
production,
which
results
in
a
variety
of
anemias.
Heme
is
the
part
of
the
hemoglobin
molecule
that
contains
iron
and
binds
oxygen.
In
the
1997
subchronic
rat
study
which
used
the
current
98%
a.
i.
formulation,
the
red
blood
cell
count
was
normal,
but
the
red
blood
cell
mass
was
decreased
due
to
the
small
size
of
the
red
blood
cells,
presumably
because
of
inhibition
of
the
protoporphyrinogen
oxidase
enzyme.
The
anemia
was
generally
mild
in
other
studies,
with
varying
hematologic
abnormalities
described
in
the
rat,
mouse,
and
dog
studies.
8
Mild
liver
toxicity
was
described
in
the
1997
subchronic
rat
study
which
used
the
current
98%
formulation.
Increased
liver
weight
was
accompanied
by
very
slight
increases
in
liver
enzyme
activities
and
minimal
histopathologic
changes.
Similar
effects
also
occurred
in
the
other
subchronic
and
chronic
rat,
mouse,
and
dog
studies.
There
were
typically
few
histopathological
lesions
seen
in
the
liver,
although
hepatocyte
necrosis
did
occur
in
the
mouse
and
dog
studies.
Renal
toxicity
was
most
severe
in
the
2
generation
reproduction
study
in
rats,
in
which
pelvic
mineralization
occurred.
Developmental
studies
using
the
current
98%
technical
material
found
no
developmental
toxicity
in
rats
whereas
an
increase
in
late
resorptions
occurred
in
the
rabbit
study
(principally
in
1
litter).
A
developmental
study
in
rats
using
the
older
71%
technical
material
found
increased
early
resorptions,
decreased
fetal
weight,
and
increased
incidence
of
fetal
visceral
and
skeletal
variations
and
malformations.
A
developmental
study
in
rabbits
with
formulation
manufactured
from
the
older
technical
material
found
increased
early
resorptions
and
decreased
litter
size.
A
reproduction
study
with
71%
technical
material
reported
decreased
live
pups
per
litter
and
decreased
pup
body
weights.
The
newer
technical
material
(96
99%
a.
i.)
was
tested
in
12
genetic
toxicology
studies,
which
included
assessments
of
gene
mutation,
chromosomal
aberrations,
and
DNA
damage.
All
assays
were
negative,
except
for
one
Ames
assay
which
was
positive
only
at
high,
insoluble
levels.
A
subsequent
Ames
assay
with
96%
material
was
negative.
The
older
72%
technical
material
and
a
polar
fraction
were
tested
in
eight
genetic
toxicology
studies.
Both
Ames
assays
and
a
mouse
lymphoma
study
were
positive
for
the
72%
technical
material.
The
polar
fraction
of
the
72%
technical
material
was
also
positive
in
an
Ames
assay.
Oxyfluorfen
is
classified
as
a
category
C,
possible
human
carcinogen
based
upon
combined
hepatocellular
adenomas/
carcinomas
in
the
mouse
carcinogenicity
study.
The
Cancer
Peer
Review
Committee
recommended
a
linear,
low
dose
extrapolation
for
human
risk
assessments,
with
a
Q1*
of
7.32
x
10
2
(mg/
kg/
day)
1
in
human
equivalents.
Lactofen,
a
compound
that
is
structurally
related
to
oxyfluorfen,
has
recently
been
identified
as
a
non
genotoxic
hepatocarcinogen
with
a
mechanism
of
action
due
to
peroxisome
proliferation.
Peroxisome
proliferator
compounds
are
known
to
cause
an
increased
number
of
peroxisomes
in
rodent
liver
cells.
Peroxisomes
are
membrane
bound
vesicles
of
enzymes
in
liver
cells
which
produce
hydrogen
peroxide.
The
increased
peroxisomes
leak
hydrogen
peroxide
which
cause
DNA
effects
and
act
as
promoters
for
cancer
in
rodent
livers.
Dow
AgroSciences
has
committed
to
undertake
mechanistic
studies
to
determine
whether
or
not
oxyfluorfen
acts
via
a
mechanism
involving
peroxisome
proliferation.
If
oxyfluorfen
is
shown
to
be
a
peroxisome
proliferator,
an
MOE
approach
(indicative
of
a
non
linear
dose
response),
rather
than
a
Q*
approach
would
be
more
appropriate
to
quantify
cancer
risks.
If
oxyfluorfen
is
determined
to
be
a
peroxisome
proliferator,
EPA
will
re
evaluate
cancer
risks
and
risk
mitigation
decisions
for
oxyfluorfen.
9
Further
details
on
the
toxicity
of
oxyfluorfen
can
be
found
in
the
April
29,
2002,
Human
Health
Risk
Assessment,
and
the
August
8,
2001
memo
entitled,
"Oxyfluorfen:
Toxicology
Chapter
for
the
RED".
A
brief
overview
of
the
studies
used
for
the
human
health
risk
assessment
and
other
relevant
information
is
outlined
in
Table
2
.
b.
FQPA
Safety
Factor
The
FQPA
Safety
Factor
was
removed
(i.
e.
reduced
to
1X)
based
on
the
following
factors:
1)
There
does
not
appear
to
be
any
increased
susceptibility
in
animals
due
to
pre
or
postnatal
exposure
to
oxyfluorfen
based
upon
the
developmental
and
reproductive
toxicity
studies
reviewed.
Although
two
does
in
the
high
dose
group
of
the
98%
ai
rabbit
developmental
study
aborted,
these
abortions
were
considered
secondary
to
the
debilitating
condition
(generalized,
systemic
toxicity)
of
the
mothers
and
occurred
at
the
same
dose
that
cause
maternal
toxicity;
2)
Although
neurotoxicity
studies
were
not
performed,
there
was
no
indication
of
neurotoxicity
in
the
submitted
developmental
and
reproductive
studies
or
in
the
published
literature.
A
developmental
neurotoxicity
study
was
not
required;
and
3)
The
dietary
(food
and
drinking
water)
and
non
dietary
(residential)
exposure
assessments
will
not
underestimate
the
potential
exposures
for
infants
and
children.
The
FQPA
safety
factor
is
applicable
to
the
dietary
and
residential
risk
assessments
for
all
population
subgroups.
c.
Population
Adjusted
Dose
(PAD)
Dietary
exposure
estimates
are
expressed
in
mg/
kg
body
weight/
day
and
as
a
percent
of
the
acute/
chronic
Population
Adjusted
Dose
(a/
cPAD)
which
is
the
RfD
taking
into
account
the
FQPA
safety
factor.
This
procedure
is
performed
for
each
population
subgroup.
There
are
no
aPADs
for
oxyfluorfen
because
an
appropriate
acute
endpoint
was
not
identified.
Resorptions
seen
in
the
rabbit
developmental
study
were
not
used
as
an
acute
endpoint
because
they
were
not
considered
indicative
of
a
one
time
exposure;
rather,
they
were
considered
secondary
to
the
debilitating
condition
of
the
mothers.
The
cPAD
is
a
risk
expression
reflecting
the
Reference
Dose
that
has
been
adjusted
to
account
for
the
FQPA
safety
factor
(i.
e.,
RfD/
FQPA
safety
factor).
In
the
case
of
oxyfluorfen,
the
FQPA
safety
factor
is
1;
therefore,
the
chronic
RfD
equals
the
chronic
PAD.
A
risk
estimate
that
is
less
than
100%
of
the
chronic
PAD
does
not
exceed
the
Agency's
risk
concern.
d.
Endpoints
and
Doses
for
Risk
Assessment
All
doses
for
risk
assessment
purposes
were
assessed
along
with
the
uncertainty
factors
of
10X
for
interspecies
extrapolation
and
10X
for
intraspecies
variability.
An
additional
uncertainty
factor
of
3X
was
applied
to
intermediate
term
exposures
because
the
dose
was
derived
from
the
LOAEL.
No
short
or
immediate
term
oral
endpoints
are
necessary
due
to
negligible
postapplication
residential
exposure.
Long
term
endpoints
are
also
not
needed,
as
all
exposures
are
expected
to
be
of
short
or
intermediate
term
duration.
10
Table
2.
Summary
of
Toxicological
Endpoints
and
Other
Factors
Used
in
the
Human
Health
Risk
Assessment
for
Oxyfluorfen
Assessment
Dose
(mg/
kg/
day)
Endpoint
UF
c
Study
Chronic
Dietary
NOAEL
=
3.0
Liver
toxicity
occurring
in
dogs
and
mice
at
the
LOAEL
of
33
mg/
kg/
day
(
)
and
42
mg/
kg/
day
(
)
mice.
100
Chronic
dog
and
mouse
carcinogenicity
studies
Cancer
Q1*
=
7.32
x
10
2
(mg/
kg/
day)
1
Combined
hepatocellular
adenomas
and
carcinomas.
n/
a
Mouse
carcinogenicity
study
Dermal,
Short
Term
a
NOAEL=
30
Clinical
signs
seen
at
the
maternal
LOAEL
of
90
mg/
kg/
day
100
Developmental
rabbit
study
(1998)
Dermal,
Intermediate
Term
a
LOAEL
=
32
Liver
toxicity
and
anemia
seen
at
the
LOAEL
of
32
mg/
kg/
day.
300
90
day
mouse
Inhalation,
ShortTerm
b
NOAEL
=
30
Clinical
signs
seen
at
the
maternal
LOAEL
of
90
mg/
kg/
day.
100
Developmental
rabbit
study
(1998)
Inhalation,
Intermediate
Term
b
LOAEL
=
32
Liver
toxicity
and
anemia
seen
at
the
LOAEL
of
32
mg/
kg/
day.
300
90
day
mouse
NOAEL
=
no
observed
adverse
effect
level;
LOAEL
=
lowest
observed
adverse
effect
level;
UF=
uncertainty
factor;
RfD
=
reference
dose.
a.
An
oral
endpoint
was
used
for
dermal
exposure:
a
dermal
absorption
factor
of
18%
of
oral
exposure
was
selected
from
a
dermal
absorption
study
in
rats.
b.
An
oral
endpoint
was
used
for
inhalation
exposure:
inhalation
exposure
is
assumed
equivalent
to
oral
exposure.
c.
Uncertainty
factors
of
10x
for
intraspecies
variability,
10x
for
interspecies
extrapolation
and
3x
for
lack
of
a
NOAEL
e.
Exposure
Assumptions
Oxyfluorfen
chronic
dietary
exposure
assessments
were
conducted
using
the
Dietary
Exposure
Evaluation
Model
(DEEM™)
software
Version
7.73,
which
incorporates
consumption
data
from
USDA's
Continuing
Surveys
of
Food
Intake
by
Individuals
(CSFII),
1989
1992.
The
1989
92
data
are
based
on
the
reported
consumption
of
more
than
10,000
individuals
over
three
consecutive
days,
and
therefore
represent
more
than
30,000
unique
"person
days"
of
data.
Foods
"as
consumed"
(e.
g.,
apple
pie)
are
linked
to
raw
agricultural
commodities
and
their
food
forms
(e.
g.,
apples
cooked/
canned
or
wheat
flour)
by
recipe
translation
files
internal
to
the
DEEM
software.
Consumption
data
are
averaged
for
the
entire
US
population
and
within
population
subgroups
for
chronic
exposure
assessment.
For
chronic
exposure
and
risk
assessment,
an
estimate
of
the
residue
level
in
each
food
or
food
form
(e.
g.,
orange
or
orange
juice)
on
the
commodity
residue
list
is
multiplied
by
the
average
daily
consumption
estimate
for
that
food/
food
form.
The
resulting
residue
consumption
estimate
for
each
food/
food
form
is
summed
with
the
residue
consumption
estimates
for
all
other
food/
food
forms
on
the
commodity
residue
list
to
arrive
at
the
total
estimated
exposure.
Exposure
estimates
are
expressed
in
mg/
kg
body
weight/
day
and
as
a
percent
of
the
cPAD.
This
procedure
is
performed
for
each
population
subgroup.
Anticipated
residues
were
calculated
using
either
USDA
Pesticide
Data
Program
(PDP)
monitoring
data
or
field
trial
data.
Both
data
sets
are
consistent
in
that
they
show
essentially
all
non
detectable
residues,
with
the
same
limit
of
detection
(0.01
ppm).
Monitoring
data
for
11
oxyfluorfen
generated
through
the
USDA
PDP
were
from
the
years
1996
to
1999
(total
of
3,720
samples
analyzed).
These
data
were
used
for
the
following
crops:
apple
juice,
apples,
carrots,
grapes,
green
beans
(canned
and
fresh),
high
fructose
corn
syrup,
oranges,
peaches,
spinach
(
fresh
and
canned),
sweet
corn,
sweet
peas,
tomatoes
(fresh
and
canned),
sweet
potatoes,
orange
juice,
pears,
winter
squash
(fresh
and
canned),
cantaloupe,
grape
juice,
strawberries
(fresh
and
frozen)
and
sweet
bell
peppers.
There
were
no
residues
detected
on
these
commodities.
In
addition,
estimates
of
percent
crop
treated
(%
CT)
generated
by
the
Biological
and
Economic
Analysis
Division
(BEAD),
Office
of
Pesticide
Programs,
were
used
to
refine
the
assessment.
Although
a
Tier
2/
3
dietary
risk
assessment
was
conducted
and
is
the
most
refined
assessment
to
date
for
oxyfluorfen,
there
are
some
uncertainties
associated
with
the
exposure
estimates
as
follows:
(i)
the
use
of
½
LOQs
instead
of
½
LODs
for
field
trial
residue
values
will
tend
to
overestimate
the
residue
values
from
the
field
trial
studies
(all
of
the
field
trial
studies
were
non
detects;
therefore,
this
assessment
is
an
upper
bound
and
the
real
residues
are
somewhere
between
this
estimate
and
zero);
(ii)
no
cooking
studies
were
used;
(iii)
tolerance
level
residues
for
bananas
and
cacao
beans
and
100%
crop
treated
for
cacao
beans
were
used;
and
(iv)
DEEM
default
processing
factors
were
used
in
the
assessment.
f.
Dietary
Risk
from
Food
In
general,
a
non
cancer
chronic
dietary
(food)
risk
estimate
of
less
than
100%
of
the
chronic
PAD
is
not
of
concern
to
the
Agency.
Cancer
risks
less
than
1
x
10
6
are
also
not
of
concern
to
the
Agency.
Oxyfluorfen
is
classified
as
a
category
C,
possible
human
carcinogen
based
upon
combined
hepatocellular
adenomas/
carcinomas
in
the
mouse
carcinogenicity
study.
A
cancer
dietary
(food)
risk
assessment
using
a
low
dose
linear
extrapolation
was
conducted.
As
shown
in
Table
3,
chronic
dietary
risk
is
<1%
of
the
chronic
PAD
for
the
U.
S.
general
population
and
all
population
subgroups.
Using
the
Q1*
of
7.32
x
10
2
results
in
a
maximum
estimated
lifetime
cancer
risk
to
the
U.
S.
general
population
of
3.8
x
10
7
.
Neither
the
non
cancer
or
the
cancer
risk
estimates
pose
a
dietary
risk
concern
for
food
for
any
population
subgroup.
Table
3.
Summary
of
Dietary
Exposure
and
Risk
for
Oxyfluorfen
Population
Subgroup
Chronic
Dietary
Cancer
Dietary
Exposure
(mg/
kg/
day)
%
cPAD
Risk
U.
S.
Population
0.
000005
<1
3.8
x
10
7
Infants
(<
1
year
old)
0.000011
<1
Children
1
6
years
0.
000012
<1
2.
Dietary
Risk
from
Drinking
Water
Drinking
water
exposure
to
pesticides
can
occur
through
ground
water
and
surface
water
contamination.
For
oxyfluorfen,
EPA
considered
chronic
(lifetime)
drinking
water
risks
and
used
modeling
to
estimate
those
risks.
The
PRZM
EXAMS/
IR
model
was
used
to
estimate
12
surface
water
concentrations,
and
SCI
GROW
was
used
to
estimate
groundwater
concentrations.
Both
of
these
models
are
considered
to
be
screening
tools,
with
the
PRZM
EXAMS
model
being
somewhat
more
refined
than
SCI
GROW.
Oxyfluorfen
in
the
environment
is
expected
to
be
very
persistent
with
low
mobility.
In
general,
oxyfluorfen
degrades
very
slowly
in
both
soil
and
water
and
binds
strongly
to
soil
containing
organic
matter.
Oxyfluorfen
contaminates
surface
water
through
spray
drift
and
runoff;
the
latter
is
considered
a
much
larger
contributor
to
surface
water
contamination.
Oxyfluorfen
is
unlikely
to
contaminate
ground
water
because
it
is
relatively
immobile
in
the
soil
column;
therefore,
the
likelihood
of
leaching
is
small.
Some
samples
have
been
collected
and
analyzed
for
oxyfluorfen
in
water
and
sediments
in
the
Columbia
River
basin
of
Oregon
and
Washington
as
a
result
of
an
August,
2000
oxyfluorfen
(Goal
2XL)
spill
into
the
Fifteen
Mile
Creek
near
its
mouth
into
the
Columbia
River.
Of
35
background
sediment
measurements
made
in
nearby
rivers
and
streams
which
were
reportedly
unaffected
by
the
spill,
2
detections
of
oxyfluorfen
in
sediment
were
noted.
The
higher
detection,
541
ppb,
was
downstream
of
orchards.
Except
for
the
data
collected
near
the
spill
site
in
Fifteen
Mile
Creek
(near
the
Columbia
River),
no
targeted
water
monitoring
data
are
available
for
dissolved
phase
oxyfluorfen.
The
U.
S.
Geological
Survey
(USGS)
monitored
oxyfluorfen
concentrations
in
suspended
sediment
at
one
site
in
the
San
Joaquin
River
in
central
California
during
several
years
in
the
1990's.
The
highest
average
concentration
of
oxyfluorfen
in
sediment
was
27.2
ppb.
Assuming
partitioning
between
water
and
sediment
is
reversible
and
at
equilibrium,
the
dissolved
oxyfluorfen
concentration
was
estimated
to
by
0.27
µg/
L
(calculated
using
the
average
Kd
partitioning
coefficient
of
100.)
Additionally,
the
USGS
EPA
pilot
reservoir
monitoring
program
did
not
detect
oxyfluorfen
concentrations
in
raw
and
finished
drinking
water.
However,
due
to
the
limited
geographic
range
of
these
data
and
the
uncertainties
in
estimating
the
dissolved
concentration,
these
data
are
insufficient
for
use
in
the
drinking
water
assessment.
The
monitoring
data
are
not
adequate
to
perform
a
quantitative
drinking
water
assessment
for
the
following
reasons:
1)
The
majority
of
the
data
are
limited
to
sediment
levels,
whereas
dissolved
phase
concentrations
are
more
useful
for
estimating
drinking
water
exposure;
and
2)
Oxyfluorfen
use
is
widespread
but
the
monitoring
data
are
limited
to
a
few
locations.
The
monitoring
data
are
temporally
limited.
a.
Surface
Water
PRZM/
EXAMS,
a
Tier
II
model
with
index
reservoir
(IR)
scenarios
and
a
percent
cropped
area
(PCA)
adjustment
factor,
was
used.
For
Tier
II
surface
water
screening
assessments,
OPP
uses
the
PRZM
EXAMS
model
which
accommodates
the
specific
characteristics
of
the
chemical
and
which
include
site
specific
information
regarding
the
application
method
and
impact
of
daily
weather
on
the
treated
field
over
a
period
of
30
more
years.
The
PRZM
EXAMS
model
was
developed
to
provide
`best
estimates'
of
chemical
concentrations
in
the
modeled
water
bodies
based
on
the
fate
characteristics
of
the
chemical.
The
13
input
values
specific
to
each
of
the
modeled
cropping
scenarios
and
the
fate
parameter
inputs
for
a
given
chemical
are
intended
to
be
conservative.
Apples
in
Oregon
(2
lbs
ai/
acre,
1X/
season)
was
chosen
to
estimate
the
concentration
of
oxyfluorfen
in
surface
drinking
water.
This
scenario
was
selected
after
evaluating
results
from
additional
scenarios
chosen
to
represent
areas
where
oxyfluorfen
is
heavily
used
or
has
the
potential
for
heavy
use.
b.
Ground
Water
The
SCI
GROW
model,
a
Tier
I
model,
was
used
to
estimate
the
concentration
of
oxyfluorfen
in
drinking
water
from
shallow
ground
water
sources.
Currently,
there
is
no
Tier
II
assessment
tool
for
groundwater.
Since
SCI
GROW,
unlike
the
PRZM/
EXAMS
surface
water
model,
does
not
require
a
specific
crop
scenario,
EFED
used
the
highest
use
rate
of
four
applications
at
2.0
lbs
ai/
acre
as
allowed
for
ornamentals
to
estimate
the
concentration
of
oxyfluorfen
in
drinking
water
from
shallow
groundwater
sources.
c.
Drinking
Water
Levels
of
Comparison
(DWLOCs)
To
determine
the
maximum
allowable
contribution
of
pesticide
residues
in
water,
EPA
first
looks
at
how
much
of
the
overall
allowable
risk
is
contributed
by
food
and
then
determines
a
"drinking
water
level
of
comparison"(
DWLOC)
to
determine
whether
modeled
or
monitoring
levels
exceed
this
level.
The
Agency
uses
the
DWLOC
as
a
surrogate
to
capture
risk
associated
with
exposure
from
pesticides
in
drinking
water.
The
DWLOC
is
the
maximum
concentration
in
drinking
water
which,
when
considered
together
with
dietary
exposure,
does
not
exceed
a
level
of
concern.
The
results
of
the
Agency's
drinking
water
analysis
are
summarized
here.
Details
of
the
drinking
water
analysis
are
found
in
the
Revised
Human
Health
Risk
Assessment
for
Oxyfluorfen,
dated
April
29,
2002.
(1)
DWLOCs
for
Chronic
(Cancer
and
Non
cancer)
Exposure
Chronic
and
cancer
DWLOCs
for
oxyfluorfen
were
calculated
based
on
anticipated
residues
in
food
only;
DWLOCs
calculated
from
food
+
residential
exposure
are
presented
in
the
aggregate
risk
section
of
this
document.
Comparisons
made
between
DWLOCs
and
the
estimated
concentrations
of
oxyfluorfen
in
surface
water
and
ground
water
are
presented
in
Table
4.
If
model
estimates
are
less
than
the
DWLOC,
there
is
generally
no
dietary
(food
+
water)
concern.
14
Table
4.
Oxyfluorfen
Summary
of
Chronic
(Non
cancer)
DWLOC
Calculations
Population
Subgroup
DWLOCs
(ppb)
1
EECs
(ppb)
Chronic
Cancer
Surface
Water
(PRZM/
EXAMS)
Ground
Water
(SCI
GROW)
Chronic
2
Cancer
3
Chronic
and
Cancer
U.
S.
Population
1050
0.315
7.1
5.
7
0.08
All
Infants
(<
1Year)
900
N/
A
Children
(1
6
years)
300
N/
A
Females
(13
50
years)
300
N/
A
1
DWLOCs
based
on
food
exposure
only.
2
Chronic
risk
based
on
the
1
in
10
yearly
concentration
3
Cancer
risk
based
on
the
36
year
annual
mean
concentration
(2)
Chronic
Dietary
Risk
As
shown
in
Table
4,
the
chronic
DWLOCs,
ranging
from
300
1050
for
all
populations,
are
substantially
higher
than
the
estimated
environmental
concentrations
(EECs)
of
oxyfluorfen
in
surface
and
groundwater
(7.1
ppb
and
0.08
ppb
respectively)
based
on
conservative
modeling.
Consequently,
chronic
drinking
water
risk
from
surface
or
groundwater
sources
is
below
EPA's
level
of
concern.
(3)
Cancer
Dietary
Risk
The
cancer
DWLOC
is
the
concentration
of
a
pesticide
in
drinking
water
that
results
in
a
negligible
cancer
risk
when
considered
together
with
estimated
food
exposure
(1
x
10
6
or
less).
Upon
comparison
of
the
cancer
DWLOC
with
the
environmental
concentrations
of
oxyfluorfen
estimated
using
conservative
modeling,
the
surface
water
concentration
(5.7
ppb)
is
greater
than
the
cancer
DWLOC
(0.315
ppb).
Thus,
there
appears
to
be
a
potential
concern
for
oxyfluorfen
residues
in
surface
water.
However,
the
estimated
drinking
water
concentrations
are
considered
to
be
conservative.
First,
the
2
lb
ai/
broadcast
acre/
season
maximum
labeled
rate
used
in
the
drinking
water
modeling
assessment
is
not
typically
applied
as
a
broadcast
spray
but
rather
as
a
banded
application
between
rows
of
perennial
crops
such
as
fruit/
nut
trees
and
artichokes,
which
leaves
approximately
50
75%
of
the
actual
land
area
untreated.
Careful
targeting
of
the
spray
is
required
because
oxyfluorfen
is
non
selective
and
will
damage
crops.
The
use
rate
for
the
perennial
crops
per
acre
of
total
land
area
is
generally
around
0.5
to
1.0
lbs
ai/
acre.
Although
there
are
oxyfluorfen
use
sites
that
are
broadcast
treated,
such
as
bulb
vegetables
or
fallow
land,
these
sites
have
a
lower
maximum
rate,
typically
0.5
lbs
ai/
acre.
The
drinking
water
assessment
also
assumes
that
the
maximum
labeled
rate
of
2
lbs
ai/
acre
is
applied
every
year
for
70
years
when
it
is
known
that
the
average
reported
use
rate
(regardless
of
application
method)
is
less
than
½
of
the
maximum
labeled
rate
(<
1
lb
ai/
acre).
Based
on
information
provided
by
growers,
extension
service,
and
industry,
the
higher
2
lb
rate
15
is
used
more
during
the
first
couple
of
establishment
years
or
when
a
poorly
managed
orchard/
field
is
purchased;
after
which
lower
rates
are
generally
used
to
manage
weeds
at
a
maintenance
level.
3.
Non
dietary
Risk
from
Residential
Uses
Oxyfluorfen
is
used
in
the
residential
environment
by
homeowners
to
kill
weeds
on
patios,
driveways
and
similar
surfaces.
Oxyfluorfen
homeowner
products
are
intended
solely
for
spot
treatment;
they
are
not
used
for
broadcast
treatment
of
lawns
because
they
kill
grass.
Residential
formulations
contain
0.25%
to
0.70%
oxyfluorfen
by
weight
and
are
packaged
in
a
RTU
sprinkler
jug,
a
RTU
trigger
sprayer
or
as
a
liquid
to
be
mixed
in
a
sprinkler
can
or
tank
sprayer.
Table
5.
Residential
Use
Product
Information
for
Oxyfluorfen
Product/
Registrant
Formulation
and
Application
Method
Application
Rate
(lbs
ai/
acre)
Kleenup
Super
Edger/
Platte
Chemical
Corp
Contains
0.25%
oxyfluorfen
in
pre
mixed
one
pint
to
one
gallon
containers.
Applied
from
a
RTU
trigger
sprayer,
a
RTU
sprinkler
jug
or
from
a
tank
sprayer.
4.8
Ortho
GroundClear
SuperEdger/
Scotts
Company
Ready
to
use
liquid
containing
0.25%
oxyfluorfen.
Applied
directly
from
the
jug
which
has
an
applicator
spout.
4.8
Ortho
GroundClear
Triox
Total
Vegetation
Killer
A
/Scotts
Company
Concentrate
containing
0.70%
oxyfluorfen.
Mixed
with
water
and
applied
from
a
sprinkler
can.
8.9
a.
Exposure
The
assessment
evaluated
four
methods
of
application:
1)
low
pressure
tank
sprayer,
2)
"mix
your
own"
sprinkler
can,
3)
ready
to
use
(RTU)
invert
sprayer,
and
4)
RTU
trigger
sprayer.
The
residential
assessment
for
oxyfluorfen
only
addresses
the
applicator,
because
negligible
postapplication
exposure
is
anticipated
from
spot
treatment
of
weeds.
Exposure
data
for
scenarios
1
and
4
were
taken
from
an
Outdoor
Residential
Exposure
Task
Force
(ORETF)
mixer/
loader/
applicator
exposure
study
with
carbaryl.
Exposure
data
for
scenarios
2
and
3
were
derived
from
an
ORETF
proprietary
study
that
was
conducted
during
the
application
of
diazinon
to
lawns
using
"Mix
Your
Own"
and
"Ready
to
Use"
hose
end
sprayers.
Dermal
and
inhalation
exposures
are
combined
in
this
assessment.
MOEs
were
calculated
for
short
term
(1
30
day)
exposure
scenarios
only
based
on
the
use
pattern.
General
assumptions
used
in
the
residential
handler
risk
assessment
are
as
follows:
°
Clothing
consisted
of
a
short
sleeved
shirt,
short
pants
and
no
gloves.
16
°
An
area
of
200
sq
ft
per
application
was
treated
with
one
gallon
of
the
"ready
to
use"
product
or
2.67
quarts
of
the
"mix
your
own"
product
in
an
invert
jug
or
sprinkler
can.
An
area
of
300
sq
ft
per
application
was
treated
with
one
gallon
of
product
in
a
low
pressure
hand
carried
tank
sprayer.
°
Two
applications
are
made
per
year.
°
Applicators
are
assumed
to
have
50
years
of
potential
exposure
over
a
70
year
life
span.
b.
Residential
Handler
Risk
Estimates
Residential
handler
non
cancer
risk
is
measured
as
a
Margin
of
Exposure
(MOE),
which
determines
how
closely
the
exposure
comes
to
a
NOAEL.
Since
the
FQPA
safety
factor
was
reduced
to
1X,
the
Agency's
level
of
concern
(i.
e.,
target
MOE)
is
100.
As
with
dietary
risk,
residential
cancer
risk
estimates
less
than
1.0
x
10
6
do
not
exceed
the
Agency's
level
of
concern.
As
shown
in
Table
6,
none
of
the
residential
applicator
scenarios
alone
are
of
concern
because
the
MOEs
for
non
cancer
effects
are
greater
than
100
and
the
cancer
risks
are
less
than
1.0
x
10
6
.
The
highest
residential
applicator
cancer
risk
is
8.7
x
10
7
for
the
trigger
pump
sprayer
scenario;
however,
this
risk
estimate
is
considered
conservative
because
it
is
not
anticipated
that
homeowners
would
use
two
gallons
of
product/
year
if
applying
with
a
trigger
sprayer.
Assuming
one
gallon/
year,
the
cancer
risk
estimate
for
the
trigger
pump
sprayer
is
4.4
x
10
7
.
Table
6.
Residential
Risk
Estimates
for
Non
cancer
and
Cancer
Effects
Spot
Treatment
Scenarios
Combined
Absorbed
Daily
Dose
(mg/
kg/
day)
Non
Cancer
Short
term
Risk
(MOE)
Lifetime
Absorbed
Daily
Dose
(mg/
kg/
day)
Cancer
Risk
Low
Pressure
Tank
Sprayer
2.
5
x
10
3
12,000
8.5
x
10
6
6.2
x
10
7
"Mix
Your
Own"
Sprinkler
Can
1.4
x
10
3
22,000
4.6
x
10
6
3.3
x
10
7
RTU
Invert
Sprayer
1.8
x
10
4
170,000
5.9
x
10
7
4.3
x
10
8
RTU
Trigger
Pump
Sprayer
3.
5
x
10
3
8,500
1.2
x
10
5
8.7
x
10
7
4.
Aggregate
Risk
The
Food
Quality
Protection
Act
amendments
to
the
Federal
Food,
Drug,
and
Cosmetic
Act
(FFDCA,
Section
408(
b)(
2)(
A)(
ii))
require
that
for
establishing
a
pesticide
tolerance,
"that
there
is
reasonable
certainty
that
no
harm
will
result
from
aggregate
exposure
to
pesticide
chemical
residue,
including
all
anticipated
dietary
exposures
and
other
exposures
for
which
there
are
reliable
information."
Aggregate
exposure
will
typically
include
exposures
from
food,
drinking
water,
residential
uses
of
a
pesticide,
and
other
non
occupational
sources
of
exposure.
For
oxyfluorfen,
aggregate
risk
assessments
were
conducted
for
short
term
(one
to
thirty
days)
and
chronic
(cancer/
non
cancer)
exposure.
Occupational
exposure
is
not
considered
in
any
aggregate
exposure
assessment.
As
noted
previously,
no
acute
dietary/
aggregate
risks
were
assessed
for
oxyfluorfen
because
no
adverse
effects
reflecting
a
single
dose
were
identified.
17
a.
Chronic
(Non
Cancer)
Aggregate
Risk
The
chronic
aggregate
risk
assessment
addresses
exposure
to
oxyfluorfen
residues
in
food
and
water
only,
as
there
are
no
chronic
residential
scenarios
identified.
As
shown
previously
in
Table
4,
comparison
of
the
chronic
DWLOCs
with
the
estimated
environmental
concentrations
of
oxyfluorfen
shows
that
estimated
surface
and
groundwater
concentrations
are
substantially
less
than
the
DWLOCs
for
all
populations.
Consequently,
the
Agency
concludes
that
residues
of
oxyfluorfen
in
food
and
drinking
water
do
not
result
in
a
chronic
aggregate
risk
of
concern.
b.
Short
term
Aggregate
Risk
Short
term
DWLOCs
were
calculated
based
upon
average
food
residues,
and
the
residential
handler
exposure
which
resulted
in
the
greatest
risk
estimate
(spot
treatment
of
weeds
using
a
RTU
trigger
pump
sprayer).
DWLOC
calculations
are
for
adults
only
since
the
residential
exposure
is
to
adult
handlers.
The
DWLOC
calculation
was
done
using
standard
body
weight
and
daily
water
consumption,
i.
e.,
70
kg/
2L
(adult
male)
and
60
kg/
2L
(adult
female).
As
shown
in
Table
7,
surface
and
ground
water
concentrations
(7.1
ppb
and
0.08
ppb
respectively),
estimated
using
modeling,
are
below
the
short
term
DWLOCs
of
8900
ppb
(females)
and
10400
ppb
(males).
Consequently,
there
are
no
short
term
aggregate
risk
concerns
from
food,
drinking
water
and
residential
exposures.
Table
7.
Short
Term
Aggregate
Risk
and
DWLOC
Calculations
Population
Aggregate
Risk
MOE
(food
+
residential)
Surface
Water
EEC
(ppb)
Ground
Water
EEC
(ppb)
Short
Term
DWLOC
1
(ppb)
Adult
Male
8600
7.1
0.
08
10400
Adult
Female
8600
7.1
0.
08
8900
c.
Aggregate
Risk
for
Cancer
Cancer
DWLOCs
were
calculated
using
average
food
residues
together
with
residential
exposure
estimates.
The
handler
exposure
scenario
which
resulted
in
the
greatest
risk
estimate
(spot
treatment
of
weeds
using
a
RTU
Trigger
Pump
Sprayer)
was
used
in
the
calculation.
DWLOC
calculations
were
done
for
adults
only
using
standard
body
weight
and
daily
water
consumption,
i.
e.,
70
kg/
2L
(adult
male).
The
chronic
food
cancer
risk
estimate
of
3.8
x
10
7
,
combined
with
the
residential
cancer
risk
estimate
of
8.7
x
10
7
,
results
in
a
food
+
residential
cancer
risk
of
1.3
x
10
6
.
Since
the
Agency's
level
of
concern
is
1.0
x
10
6
,
the
DWLOC
is
effectively
zero
and
any
additional
water
exposure
will
further
contribute
to
potential
risks
of
concern.
18
Table
8.
Cancer
Aggregate
Risk
(
Food
and
Residential)
and
DWLOC
Calculations
Population
Chronic
Food
Risk
Residential
Risk
Aggregate
Cancer
Risk
(food
and
residential)
Surface
Water
EEC
(ppb)
Ground
Water
EEC
(ppb)
Cancer
DWLOC
(ppb)
U.
S.
Pop
3.
8
x
10
7
8.7
x
10
7
1.3
x
10
6
5.7
0.
08
0
The
estimated
food
risk
is
considered
highly
conservative.
First,
PDP
analyzed
3,700
samples
on
approximately
20
different
commodities
from
1996
1999
and
found
zero
detects.
This
is
not
surprising
considering
the
fact
that,
except
for
bulb
vegetables,
oxyfluorfen
is
not
directly
applied
to
crops
due
to
damage
to
the
foliage.
Secondly,
field
trial
data
also
showed
all
residues
were
non
detects
at
an
LOD
of
0.01
ppm.
Third,
½
LOQ
(0.01
ppm)
was
used
in
the
dietary
assessment
instead
of
½
LOD
(0.003
ppm),
which
over
estimates
the
residue
values.
EPA
used
½
LOQ
rather
than
½
LOD
for
field
trial
residue
values
because
of
the
possibility
of
an
occasional
residue
of
oxyfluorfen
greater
than
0.01
ppm,
and
the
registrant's
intention
to
propose
a
new
single
analyte
enforcement
method
for
oxyfluorfen
with
a
quantitation
limit
of
0.02
ppm.
Actual
residues
are
expected
to
be
somewhere
in
between
the
calculated
estimates
and
zero.
In
addition,
the
residential
cancer
risk
estimate
of
8.7
x
10
7
is
believed
to
be
an
overestimate
since
residential
applicators
are
not
likely
to
apply
two
gallons/
year
of
a
ready
to
use
product
with
a
trigger
sprayer.
Assuming
one
gallon/
year,
the
cancer
risk
estimate
for
the
trigger
pump
sprayer
is
4.4
x
10
7
.
Therefore,
the
cancer
risk
of
6.2
x
10
7
from
use
of
the
low
pressure
tank
sprayer
can
be
considered
"worst
case".
Regardless
of
food
and
residential
exposure,
estimated
cancer
risk
from
drinking
water
alone
is
of
concern
based
on
the
surface
water
EEC
of
5.7
ppb.
As
noted
previously,
the
Agency
believes
that
the
surface
water
modeling
overestimates
the
concentration
of
oxyfluorfen
that
may
be
present
in
drinking
water.
Targeted
drinking
water
monitoring
data
would
allow
refinement
of
the
EECs.
5.
Occupational
Risk
Occupational
workers
can
be
exposed
to
a
pesticide
through
mixing,
loading,
and/
or
applying
a
pesticide,
or
re
entering
treated
sites.
Occupational
handlers
of
oxyfluorfen
include:
individual
farmers
or
growers
who
mix,
load,
and/
or
apply
pesticides,
and
professional
or
custom
agricultural
applicators.
Non
cancer
risk
for
all
of
these
potentially
exposed
populations
is
measured
by
a
Margin
of
Exposure
(MOE)
which
determines
how
close
the
occupational
exposure
comes
to
a
No
Observed
Adverse
Effect
Level
(NOAEL).
In
the
case
of
oxyfluorfen,
dermal/
inhalation
MOEs
greater
than
100
for
short
term
and
300
for
intermediate
term
do
not
exceed
the
Agency's
level
of
concern.
Cancer
risks
greater
than
1.0
X
10
4
(one
in
ten
thousand)
for
the
occupational
population
exceeds
the
Agency's
level
of
concern.
EPA
closely
examines
occupational
cancer
risks
in
the
1
x
10
4
to
1
x
10
6
range
and
seeks
cost
effective
ways
to
reduce
occupational
cancer
risks
to
the
greatest
extent
feasible,
preferably
10
6
or
less.
19
a.
Toxicity
The
toxicological
endpoints,
and
other
factors
used
in
the
occupational
risk
assessment
for
oxyfluorfen
are
listed
previously
in
Table
2.
The
acute
toxicity
profile
for
technical
oxyfluorfen
is
listed
below
in
Table
9.
Oxyfluorfen
is
of
low
acute
toxicity
and
is
in
toxicity
category
IV
for
acute
oral
and
inhalation
toxicity
and
is
category
III
for
acute
dermal
toxicity.
Oxyfluorfen
is
a
slight
eye
and
dermal
irritant
and
is
not
a
dermal
sensitizer.
Table
9.
Acute
Toxicity
of
Technical
Oxyfluorfen
Study
Type
Test
Material
MRID
Results
Toxicity
Category
Acute
Oral
96%
44712010
LD50
>
5000
mg/
kg
IV
97.1%
44828903
LD50
>
5000
mg/
kg
IV
Acute
Dermal
96%
44712011
LD50
>
2000
mg/
kg
III
97.1%
44828904
LD50
>
5000
mg/
kg
IV
Acute
Inhalation
96%
44712012
LC50
>
3.71
mg/
L
IV
Primary
Eye
Irritation
96%
44712013
slight
irritant
IV
96%
44828906
negative
IV
Primary
Skin
Irritation
96%
44712014
slight
irritant
IV
96%
44828905
negative
IV
Dermal
Sensitization
96%
44712015
negative
23%
44814901
negative
b.
Handler
Exposure
EPA
has
determined
that
there
are
potential
exposures
to
mixers,
loaders,
applicators,
or
other
handlers
during
usual
use
patterns
associated
with
oxyfluorfen.
Agricultural
liquid
formulations
of
oxyfluorfen
are
applied
using
large,
average
or
all
terrain
vehicle
(ATV)
groundboom
rigs.
Aerial
application
is
generally
used
only
for
fallow
fields
and
bulb
vegetables.
Chemigation
is
mainly
used
for
over
the
top
application
to
bulb
vegetables
and
for
drip
application
to
some
orchard
trees,
however,
chemigation
is
often
prohibited
on
product
labels.
Granular
oxyfluorfen
is
applied
to
field
and
container
grown
ornamentals
with
broadcast
spreaders.
Based
upon
the
application
methods,
the
following
exposure
scenarios
were
developed:
Application
Method
Exposure
Scenario
1.
Large
Groundboom
1A
Mix/
Load
Liquids
Large
Groundboom
(can
treat
200
acres/
day)
1B
Spray
Application
Large
Groundboom
2.
Average
Groundboom
2A
Mix/
Load
Liquids
Average
Groundboom
(can
treat
80
acres/
day)
2B
Spray
Application
Average
Groundboom
3.
ATV
Groundboom
3A
Mix/
Load
Liquids
ATV
Groundboom
3B
Spray
Application
ATV
Groundboom
20
4.
Fixed
Wing
Aircraft
4A
Mix/
Load
Liquids
for
Aerial
Application
4B
Spray
Application
Fixed
Wing
Aircraft
4C
Flag
Aerial
Applications
5.
Chemigation
5
Mix/
Load
Liquids
Chemigation
6.
Right
of
Way
(ROW)
Sprayer
6A
Mix/
Load
Liquids
ROW
Sprayer
6B
Spray
Application
ROW
Sprayer
7.
Backpack
Sprayer
7
Mix/
Load/
Apply
Liquids
Backpack
8.
Tractor
Drawn
Broadcast
Spreader
8A
Load
Granules
into
Broadcast
Spreader
8B
Apply
Granules
with
Broadcast
Spreader
9.
Push
Type
Broadcast
Spreader
9
Broadcast
Spreader
(Load/
Apply)
EPA
has
adopted
a
methodology
to
present
the
risks
separately
for
some
scenarios
and
combine
others.
Most
of
the
hand
held
equipment
such
as
backpack
sprayers
and
push
type
granular
spreaders
are
assessed
as
a
combined
function.
With
these
types
of
small
operations
the
mixing,
loading,
and
applying
are
almost
always
carried
out
by
the
same
individual
and
there
are
data
available
to
estimate
exposure
from
these
activities.
For
equipment
such
as
fixed
wingaircraft
or
groundboom
tractors,
the
applicators
are
assessed
separately
from
the
individual
who
mixes
and
loads
the
formulated
product.
EPA
assumes
that
the
pilots
are
rarely
involved
in
mixing/
loading
procedures.
By
separating
the
two
job
functions,
EPA
can
determine
the
most
appropriate
PPE
or
engineering
controls
without
requiring
the
handler
to
wear
PPE
throughout
the
entire
workday
or
to
use
engineering
controls
that
are
not
needed.
Handler
Data
Sources
With
the
exception
of
the
push
type
broadcast
spreader
scenario,
which
relied
upon
a
high
quality
Outdoor
Residential
Exposure
Task
Force
(ORETF)
study
with
DCPA,
exposure
analyses
were
performed
with
The
Pesticide
Handlers
Exposure
Database
(PHED).
PHED
was
designed
by
a
task
force
of
representatives
from
the
US
EPA,
Health
Canada,
the
California
Department
of
Pesticide
Regulation,
and
member
companies
of
the
American
Crop
Protection
Association.
It
is
a
software
system
consisting
of
two
parts
–
a
database
of
measured
exposure
values
for
workers
involved
in
the
handling
of
pesticides
under
actual
field
conditions
and
a
set
of
computer
algorithms
used
to
subset
and
statistically
summarize
the
selected
data.
Currently,
the
database
contains
values
for
over
1,700
monitored
individuals
(i.
e.,
replicates).
The
quality
of
the
data
and
exposure
factors
represents
the
best
sources
of
data
currently
available
to
the
Agency
for
completing
these
kinds
of
assessments.
Handler
Exposure
Assumptions
The
following
assumptions
and
factors
were
used
in
order
to
complete
the
exposure
and
risk
assessments
for
occupational
handlers/
applicators:
°
The
average
work
day
was
8
hours.
21
°
Maximum
application
rates
and
daily
acreage
were
used
to
evaluate
non
cancer
occupational
risk.
°
Average
application
rates
and
daily
acreage
were
used
to
evaluate
cancer
occupational
risk.
°
A
body
weight
of
60
kg
was
assumed
for
short
term
exposures
because
the
short
term
endpoint
relates
to
females
13
50
years
of
age.
°
A
body
weight
of
70
kg
was
assumed
for
intermediate
term
exposures
because
the
intermediate
term
endpoint
is
not
gender
specific.
°
A
body
weight
of
70
kg
was
assumed
for
cancer
scenarios.
°
A
private
grower
is
assumed
to
mix,
load
and
apply
liquid
formulation
of
oxyfluorfen
5
days
per
year.
This
is
based
upon
the
90
th
to
95
th
percentile
farm
size
(taken
from
the
1997
Census
of
Agriculture)
divided
by
the
assumed
acres
treated
per
day.
It
is
also
assumed
that
approximately
one
or
two
applications
are
made
per
year
as
listed
in
the
National
Agricultural
Statistics
Service
(NASS)
data.
°
A
private
grower
is
assumed
to
load
and
apply
granular
formulations
of
oxyfluorfen
10
days
per
year
because
the
granular
labels
allow
up
to
4
applications
of
2
lb/
ai
per
year.
°
A
custom
applicator
mixes,
loads
and
applies
oxyfluorfen
30
days
per
year.
°
Baseline
PPE
includes
long
sleeve
shirts,
long
pants
and
no
gloves
or
respirator.
°
Single
Layer
PPE
includes
baseline
PPE
with
gloves.
°
Double
Layer
PPE
includes
coveralls
over
single
layer
PPE
.
°
Double
Layer
PPE
PF5
includes
a
dust/
mist
respirator.
°
Double
Layer
PPE
PF10
includes
a
cartridge
respirator.
Anticipated
use
patterns
and
application
methods,
range
of
application
rates,
and
daily
amount
of
acres
treated
were
derived
from
current
product
labeling.
With
the
exception
of
some
tropical
commodities,
application
rates
specified
on
oxyfluorfen
labels
range
from
0.5
to
2.0
pounds
of
active
ingredient
per
acre
in
agricultural
settings.
The
Agency
typically
uses
acres
treated
per
day
values
that
are
thought
to
represent
8
hours
of
application
work
for
specific
types
of
application
equipment.
c.
Handler
(Non
cancer)
Risk
Since
the
endpoint
of
concern
was
the
same
for
dermal
and
inhalation,
the
exposures
and
risks
were
combined.
The
target
MOEs
are
100
for
short
term
exposures
and
300
for
intermediate
term
exposures.
Scenarios
with
MOEs
greater
than
the
target
MOEs
are
not
of
concern
for
the
occupational
population.
Table
10
summarizes
the
ranges
of
the
combined
MOEs
for
the
various
exposure
scenarios.
A
brief
summary
of
the
specific
exposure
scenarios
with
risks
of
concern
(i.
e.
combined
MOEs
less
than
100
or
300)
is
presented
in
Table
11.
22
Table
10.
Non
Cancer
Combined
MOEs
for
Occupational
Exposure
to
Oxyfluorfen
Endpoint
Baseline
MOEs
Single
Layer
MOEs
1
Short
Term
6
14000
490
14000
Intermediate
Term
7
17000
520
15000
1
Single
layer
=
baseline
clothing
+
gloves
Table
11.
Oxyfluorfen
Handler
Exposure
Scenarios
of
Concern
a
Mitigation
Level
Scenarios
of
Concern
(MOE
=
Short
Term,
Intermediate
Term)
Baseline
PPE
1A
Mix/
load
liquids
Large
Groundboom
(MOE
=23
to
34,
29
to
43)
2A
Mix/
load
liquids
Average
Groundboom
(MOE
=
22
to
85,
27
to
110)
3A
Mix/
load
liquids
ATV
Groundboom
(MOE
=
43,
54)
4A
Mix/
load
liquids
Aerial
(MOE
=
6,
7)
5
Mix/
load
liquids
Chemigation
(MOE
=20,
24)
6A
Mix/
load
liquids
Right
of
Way
Sprayer
(MOE
=
69,
86)
6B
Spray
Application
Right
of
Way
(MOE
=
150,
190)
Single
layer
PPE
(without
respirators)
None
a.
Scenarios
are
of
concern
when
the
MOE
<100
for
short
term
exposures
or
the
MOE
<300
for
intermediate
term
exposures
The
calculations
of
occupational
handler/
applicator
non
cancer
risk
indicate
that,
at
the
single
layer
PPE
level
(which
includes
baseline
PPE
+
chemical
resistant
gloves)
none
of
the
scenarios
are
of
concern
for
short
or
intermediate
term
non
cancer
risks.
Currently,
PPE
requirements
on
labels
ranges
from
baseline
to
double
layer
with
most
of
the
labels
requiring
waterproof
or
chemical
resistant
gloves.
d.
Handler
Cancer
Risk
For
occupational
risks
between
1
x
10
6
and
1
x
10
4
,
the
Agency
will
pursue
risk
mitigation
where
feasible
and
cost
effective
to
manage
the
risks
to
1
x
10
6
.
The
cancer
risks
were
calculated
starting
with
the
PPE
level
(single
layer)
that
achieved
acceptable
MOEs
for
non
cancer
risks.
As
shown
in
Table
12,
the
cancer
risks
for
all
of
the
custom
applicator
scenarios
are
less
than
1
x
10
4
at
the
single
layer
PPE
level
and
some
of
the
applicator
scenarios
are
less
than
1
x
10
6
.
At
the
highest
level
of
mitigation
(engineering
controls)
the
risks
for
most
of
the
custom
applicator
scenarios
are
reduced
to
less
than
1
x
10
5
and
some
are
reduced
to
less
than
1
x
10
6
.
In
general,
cancer
risks
to
private
growers
were
three
to
six
times
less
than
those
for
custom
applicators
due
to
the
assumption
that
they
handle
oxyfluorfen
fewer
number
of
days
per
year
(30
days/
year
=
custom
applicators,
10
days/
year
=
private
grower
[granular],
5
days/
year
=
private
grower
[liquid]).
Cancer
risk
estimates
for
private
growers
can
be
found
in
the
May
1,
2002
Revised
Occupational
and
Residential
Exposure
and
Risk
Assessment
for
oxyfluorfen.
23
Table
12.
Summary
of
Oxyfluorfen
Cancer
Risks
for
Custom
Applicators
(30
Exposure
Days
per
Year)
Exposure
Scenario
Crops
Average
Application
Rate
(lb
ai/
Acre)
Treated
Area
(Acres/
day)
Single
Layer
Cancer
Risk
Double
Layer
Cancer
Risk
Double
Layer
PF5
Cancer
Risk
Double
Layer
PF10
Cancer
Risk
Engineering
Controls
Cancer
Risk
1A
Mix/
Load
Liquids
Large
Groundboom
Corn
0.5
200
2.3e
05
1.
9e
05
1.5e
05
1.
4e
05
7.0e
06
1B
Spray
Application
Large
Groundboom
1.4e
05
1.
2e
05
9.2e
06
8.
8e
06
4.1e
06
1A
Mix/
Load
Liquids
Large
Groundboom
Cotton,
Soybeans
0.
25
200
1.1e
05
9.
3e
06
7.3e
05
7.
2e
06
3.5e
06
1B
Spray
Application
Large
Groundboom
7.0e
06
5.
8e
06
4.6e
06
4.
4e
06
2.0e
06
2A
Mix/
Load
Liquids
Average
Groundboom
Orchards/
Vineyards
Nursery
Trees,
Mint
1.0
80
1.8e
05
1.
5e
05
1.2e
05
1.
1e
05
5.6e
06
2B
Spray
Application
Average
Groundboom
1.1e
05
9.
4e
06
7.3e
06
7.
1e
06
3.2e
06
2A
Mix/
Load
Liquids
Average
Groundboom
Onions,
Brassica
0.25
80
4.6e
06
3.
7e
06
2.9e
06
2.
8e
06
1.4e
06
2B
Spray
Application
Average
Groundboom
2.8e
06
2.
3e
06
1.8e
06
1.
8e
06
8.1e
07
3A
Mix/
Load
Liquids
ATV
Groundboom
Artichokes
1.
0
40
9.2e
06
7.
5e
06
5.8e
06
5.
6e
06
2.8e
06
3B
Spray
Application
ATV
Groundboom
5.6e
06
4.
7e
06
3.7e
06
3.
5e
06
1.6e
06
4A
Mix/
Load
Liquids
for
Aerial
Application
Fallow
Fields
0.25
350
2.0e
05
1.
6e
05
1.3e
05
1.
2e
05
6.1e
06
4B
Spray
Application
Aerial
Not
applicable
(N/
A)
N/
A
N/
A
N/
A
3.
6e
06
4C
Flag
Aerial
Applications
9.4e
06
8.
8e
06
7.7e
06
7.
6e
06
1.8e
07
5
Chemigation
Onions,
Garlic,
Horseradish
0.
25
350
2.0e
05
1.
6e
05
1.3e
05
1.
2e
05
6.1e
06
6A
Mix/
Load
Liquids
Right
of
Way
Sprayer
Right
of
Ways
1.0
50
5.7e
05
4.
7e
06
3.6e
06
3.
5e
06
1.8e
06
6B
Spray
Application
Right
of
Way
Sprayer
8.
0e
05
6.0e
05
5.
7e
05
5.7e
05
N/
A
7
Mix/
Load/
Apply
Liquids
Backpack
Conifers
1.0
2
4.1e
05
2.
7e
05
2.5e
05
2.
5e
05
N/
Aa
7
Mix/
Load/
Apply
Liquids
Backpack
Conifers
0.375
2
1.
5e
05
1.0e
05
9.
5e
06
9.4e
06
N/
A
8A
Tractor
Drawn
Broadcast
Spreader
Load
Ornamentals
1.
0
40
5.1e
06
4.
0e
06
1.6e
06
1.
3e
06
1.1e
07
8B
Tractor
Drawn
Broadcast
Spreader
Apply
Ornamentals
1.0
40
4.
3e
06
3.4e
06
1.
7e
06
1.5e
06
1.
0e
06
9
Load
and
Apply
Using
Broadcast
Spreader
Ornamentals
1.
0
5
1.
0e
05
5.9e
06
4.
6e
06
4.4e
06
N/
A
24
(1)
Post
Application
Occupational
Risk
The
post
application
occupational
risk
assessment
considered
exposures
to
workers
entering
treated
sites.
Oxyfluorfen
is
a
non
selective
herbicide
that
can
cause
leaf
damage
to
most
of
the
labeled
crops.
With
the
exception
of
bulb
vegetables
and
conifers,
which
have
more
tolerance
to
oxyfluorfen,
over
the
top
applications
are
not
recommended.
Therefore,
it
was
determined
that
significant
postapplication
exposure
is
only
anticipated
following
applications
of
oxyfluorfen
to
conifer
seedlings,
conifer
trees
and
bulb
vegetables.
Only
dermal
exposures
were
evaluated
in
the
postapplication
worker
assessment;
inhalation
exposures
are
not
anticipated
due
to
the
low
vapor
pressure
of
oxyfluorfen
(2.0
x
10
7
torr
at
20
C).
Because
oxyfluorfen
is
typically
applied
only
a
few
times
per
season
and
because
the
agricultural
scenarios
generally
occur
for
only
a
few
months
per
year,
it
was
determined
that
oxyfluorfen
exposures
would
be
in
the
range
covered
by
the
short
and
intermediate
term
toxicological
endpoints.
In
the
Worker
Protection
Standard
(WPS),
a
restricted
entry
interval
(REI)
is
defined
as
the
duration
of
time
which
must
elapse
before
residues
decline
to
a
level
so
entry
into
a
previously
treated
area
and
engaging
in
any
task
or
activity
would
not
result
in
exposures
which
are
of
concern.
Typically,
the
activity
with
the
highest
risk
will
drive
the
selection
of
the
appropriate
REI
for
the
crop.
The
restricted
entry
interval
for
oxyfluorfen
is
currently
set
at
24
hours.
(2)
Data
Sources
The
registrant
submitted
a
chemical
specific
Dislodgeable
Foliar
Residue
(DFR)
study
for
postapplication
worker
exposure.
This
study
measured
dislodgeable
foliar
residues
following
groundboom
application
of
oxyfluorfen
(Goal)
to
control
weeds
in
conifer
seedling
beds
at
a
nursery
in
Oregon.
This
study
is
of
marginally
sufficient
quality
for
use
in
risk
assessment.
The
lack
of
validation
data,
high
fortification
levels
and
low
recovery
during
the
study
are
the
most
significant
deficiencies.
In
the
absence
of
acceptable
chemical
specific
DFR
data,
standard
Agency
assumptions
were
also
used
for
comparative
purposes:
the
initial
percent
of
application
rate
assumed
to
be
available
as
DFR
was
20%
for
bulb
vegetables
and
conifers,
and
the
dissipation
rate
per
day
was
assumed
to
be
10%.
The
transfer
coefficients
are
based
on
proprietary
data
from
the
Agricultural
Re
entry
Task
Force
(ARTF).
These
coefficients
range
from
300
for
low
contact
activities
such
as
scouting,
irrigating
and
thinning
fields
of
bulb
vegetables
to
3000
for
higher
contact
activities
such
as
shearing
Christmas
trees.
The
exact
transfer
coefficient
for
a
given
scenario
also
depends
upon
the
crop
height
and
foliage
development.
Currently
there
are
no
transfer
coefficients
for
conifer
seedlings
and
a
value
of
~1000
cm
2
/hr
was
chosen
for
conifer
seedling
irrigation/
scouting
based
upon
professional
judgement,
transfer
coefficients
for
similar
activities
on
other
low
crops,
and
preliminary
ARTF
data
that
is
being
collected
for
a
variety
of
related
crops.
1
Chemical
mowing
is
a
term
used
to
describe
the
practice
of
applying
post
emergent
herbicides
at
low
rates
to
stunt
or
suppress
weeds,
which
is
cost
effective
and
promotes
soil
conservation.
Chemical
mowing
can
be
used
as
a
broadcast
application
or
as
a
treatment
for
row
middles.
25
(3)
Assumptions
The
following
assumptions
were
made
regarding
post
application
occupational
exposure:
°
Occupational
post
application
cancer
risks
were
calculated
using
a
30
day
rolling
average
DFR
that
was
predicted
using
the
default
dissipation
rate
of
10
percent
per
day.
These
calculations
are
based
upon
the
assumption
that
post
application
exposure
would
only
occur
on
one
particular
farm.
This
assumption
is
considered
valid
for
conifer
seedling
nurseries
and
Christmas
tree
farms,
because
these
industries
are
less
likely
to
employ
migrant
labor
that
would
move
from
one
farm
to
the
next.
This
assumption
is
less
valid
for
bulb
vegetable
farms
that
use
migrant
labor.
°
Non
Cancer
short
term
risks
were
assessed
using
the
maximum
label
rates.
Intermediate
term
and
cancer
risks
were
assessed
using
average
application
rates.
Risks
for
conifer
trees
were
also
assessed
at
the
rate
of
0.375
lbs
ai/
acre,
which
can
be
used
for
"chemical
mowing
1
"
around
Christmas
trees.
°
It
was
assumed
that
a
private
grower
has
ten
days
of
post
application
exposure
per
year
and
a
commercial
re
entry
worker
has
thirty
days
of
post
application
exposure
per
year.
e.
Reentry
Worker
(Non
cancer)
Risk
The
length
of
time
for
non
cancer
risks
to
decline
to
levels
that
are
not
of
concern
(i.
e.,
MOEs
$
300)
was
shorter
than
the
current
REI
of
24
hours
for
all
activities
except
for
Christmas
tree
shearing,
which
required
3
days.
f.
Reentry
Worker
Cancer
Risk
A
summary
of
the
cancer
risks
for
commercial
re
entry
workers
is
presented
in
Table
13.
Risks
for
conifer
tree
activities
exceed
1.0x10
4
on
day
of
treatment.
These
risks
decline
to
less
than
1.0x10
4
in
3
days
for
all
activities.
All
of
the
scenarios
have
cancer
risks
in
excess
of
1.0x10
6
on
day
zero
and
the
time
for
these
risks
to
decline
to
1.0x10
6
ranges
from
12
to
47
days.
Cancer
risks
for
private
growers
are
three
times
less
than
commercial
workers
due
to
the
assumption
that
they
work
fewer
days
per
year.
26
Table
13.
Post
Application
Cancer
Risks
for
Commercial
Workers
(Default
Data)
Crops
Average
Application
Rate
(lbs
ai/
acre)
Activities
Cancer
Risk
on
Day
Zero
After
Treatment
Day
After
Treatment
When
Cancer
Risk
is
Less
Than:
1.0x10
4
1.0
x
10
5
1.0x10
6
Bulb
Vegetables
0.25
Irrigating,
scouting,
hand
weeding
3.3e
06
0
0
12
Tree
Seedlings,
Conifer
0.5
Irrigation,
Scouting,
Hand
Weeding
2.2e
05
0
8
30
Trees,
Conifer
1.0
Irrigation,
Scouting
4.
5e
05
0
15
37
Shearing
1.
3e
04
3
25
47
Trees,
Conifer
0.375
(chemical
mowing)
Irrigation,
Scouting
1.7e
05
0
5
27
Shearing
5.
0e
05
0
16
38
Although
the
chemical
specific
study
data
on
conifer
seedlings
has
serious
deficiencies,
the
study
is
useful
for
characterizing
oxyfluorfen
specific
DFR
levels
on
conifers,
as
the
study
suggests
dissipation
is
faster
than
default
assumptions.
Cancer
risk
using
a
30
day
rolling
average
could
not
be
calculated
using
the
conifer
DFR
data
because
the
conifer
DFR
dissipated
to
the
LOD
by
DAT
5.
When
using
the
study
data,
reentry
risks
for
conifer
tree
activities
decline
to
less
than
1.0x10
4
in
one
day
and
the
time
for
these
risks
to
decline
to
1.0x10
6
ranges
from
6
to
11
days.
Table
14.
Postapplication
Cancer
Risks
for
Commercial
Workers
(Conifer
Study
Data)
Crops
Application
Rate
(lbs
ai/
acre)
Activities
Cancer
Risk
on
Day
Zero
After
Treatment
Day
After
Treatment
When
Cancer
Risk
is
Less
Than:
1.0x10
4
1.0x10
6
Tree
Seedlings,
Conifer
0.5
Irrigation,
Scouting,
Hand
Weeding
6.9e
05
0
6
Trees,
Conifer
1.0
Irrigation,
Scouting
1.4e
04
1
8
Shearing
4.
2e
04
1
11
Trees,
Conifer
0.375
Irrigation,
Scouting
5.2e
05
0
6
Shearing
1.
6e
04
1
8
6.
Human
Incident
Data
The
Agency
consulted
and
reviewed
sources
of
information
on
health
incidents
involving
human
exposure.
Oxyfluorfen
cases
mostly
relate
to
handler
and
worker
exposure.
The
four
sources
of
information
are
OPP's
Incident
Data
System
(IDS),
American
Association
of
Poison
Control
Centers
(PCC),
California
Department
of
Pesticide
Regulation
(CDPR),
and
the
National
Pesticides
Telecommunication
Network.
CDPR
and
OPP
data
tend
to
provide
the
most
insight
into
oxyfluorfen's
association
with
human
health
incidents.
A
total
of
66
incidents
connected
with
oxyfluorfen
were
reported
in
the
OPP
Incident
Data
System
(IDS)
from
1994
to
2000.
Most
of
these
incidents
involved
irritant
effects
to
the
eyes,
skin
and
occasionally
respiratory
27
passages.
There
were
25
cases
reported
in
the
California
Pesticide
Illness
Surveillance
Program
and
the
majority
of
these
cases
involved
minor
symptoms
of
systemic
illness
such
as
headache,
dizziness
and
nausea.
During
one
of
these
incidents,
nine
of
15
field
workers
developed
symptoms
while
transplanting
cauliflower
plants
in
a
field
that
was
sprayed
about
30
minutes
earlier.
The
reentry
interval
required
on
the
label
was
24
hours.
These
illnesses
included
symptoms
of
chemical
conjunctivitis,
eye
irritation,
tingling
and
itching
of
the
skin,
nausea,
dizziness,
headache,
and
vomiting.
The
incident
report
recommends
that
measures
be
taken
to
enforce
the
reentry
interval
and
that
skin
and
eye
protection
be
worn
by
handlers
and
those
who
are
likely
to
have
substantial
contact
with
oxyfluorfen
products.
Both
PCC
and
CDPR
data
indicate
that
incidents
rarely
result
in
hospitalization
or
prolonged
absences
from
work,
which
is
expected
due
to
the
low
acute
toxicity
profile
for
oxyfluorfen.
However,
in
the
case
of
oxyfluorfen,
the
Agency
does
not
have
as
great
a
concern
for
acute
poisoning
as
for
cancer
risk,
which
is
not
covered
by
incident
data.
B.
Environmental
Risk
Assessment
A
summary
of
the
Agency's
environmental
risk
assessment
is
presented
below.
For
detailed
discussions
of
all
aspects
of
the
environmental
risk
assessment,
see
the
Environmental
Fate
and
Effects
Division
Science
Chapter
for
the
Oxyfluorfen
Reregistration
Eligibility
Decision,
dated
May
2,
2002,
available
in
the
public
docket.
1.
Environmental
Fate
and
Transport
Except
for
the
photolysis
in
water
study
(which
indicates
relatively
rapid
degradation),
laboratory
data
indicate
that
oxyfluorfen
is
persistent
(aerobic
soil
metabolism
half
lives
of
291
and
294
days
in
a
clay
loam
soil
and
556
and
596
days
in
a
sandy
loam
soil;
and
anaerobic
soil
metabolism
half
lives
between
554
and
603
days).
Adsorption/
desorption
studies
suggest
oxyfluorfen
is
relatively
immobile,
except
perhaps
when
used
on
very
sandy
soils.
The
most
likely
route
of
dissipation
is
soil
binding.
Laboratory
data
suggest
that
once
the
soil
bound
oxyfluorfen
reaches
deep
or
turbid
surface
water
it
will
persist
since
it
is
stable
to
hydrolysis
and
since
light
penetration
would
be
limited;
however,
it
may
degrade
by
photolysis
in
clear,
shallow
water.
Oxyfluorfen
can
contaminate
surface
water
through
spray
drift
and
runoff;
however,
it
is
unlikely
to
contaminate
ground
water
because
it
is
relatively
immobile
in
the
soil
column;
therefore,
the
likelihood
of
leaching
is
small.
The
major
degradate
found
in
the
environmental
fate
studies
was
2
chloro
1(
3
ethoxy
4
hydroxyphenol)
4(
trifluoromethyl)
benzene,
which
was
identified
in
the
aqueous
photolysis
study
at
$
10
%
of
the
applied
radioactivity.
Other
degradates
were
identified
in
the
aqueous
photolysis
study
but
not
quantified.
In
the
hydrolysis
study,
2
chloro
1(
3
hydroxy
4
nitrophenoxy)
4(
trifluoromethyl)
benzene
was
identified
at
a
maximum
concentration
of
1.2
1.7%
of
the
applied
radioactivity.
There
were
no
degradates
identified
in
the
anaerobic
soil
metabolism,
leaching
adsorption/
desorption
and
soil
photolysis
studies.
The
Health
Effects
Division
has
determined
that
only
parent
oxyfluorfen
is
of
toxicological
concern
for
human
health
risk
assessment.
28
2.
Ecological
Risk
The
Agency's
ecological
risk
assessment
compares
toxicity
endpoints
from
ecological
toxicity
studies
to
estimated
environmental
concentrations
based
on
environmental
fate
characteristics,
pesticide
use,
and/
or
monitoring
data.
To
evaluate
the
potential
risk
to
nontarget
organisms
from
the
use
of
oxyfluorfen
products,
EPA
calculates
a
Risk
Quotient
(RQ),
which
is
the
ratio
of
the
estimated
exposure
concentration
to
the
toxicity
endpoint
values,
such
as
the
LC50
(the
concentration
of
a
substance
which
causes
death
to
50%
of
the
test
animals).
The
RQ
is
simply
a
means
of
integrating
the
results
of
ecological
exposure
and
ecological
toxicity.
These
RQ
values
are
compared
to
levels
of
concern
(LOCs),
given
in
Table
15
which
provide
an
indication
of
the
relative
risk
the
particular
pesticide
and/
or
use
may
pose
for
nontarget
organisms.
If
the
RQ
does
not
exceed
the
LOC,
it
is
unlikely
that
the
pesticide
will
pose
a
significant
risk.
Similarly,
when
RQs
are
equal
to
or
greater
than
the
LOC,
then
the
Agency
does
have
concerns.
These
concerns
may
be
addressed
by
further
refinements
of
the
risk
assessment
or
by
mitigation.
Use,
toxicity,
fate,
and
exposure
are
considered
to
characterize
the
risk
as
well
as
the
level
of
certainty
and
uncertainty
in
the
assessment.
EPA
further
characterizes
ecological
risk
based
on
any
reported
aquatic
or
terrestrial
incidents
to
nontarget
organisms
in
the
field
(e.
g.,
fish
or
bird
kills).
Table
15.
Risk
Presumptions
for
Terrestrial
and
Aquatic
Animals
Risk
Presumption
LOC
terrestrial
animals
LOC
aquatic
animals
Acute
Risk
there
is
potential
for
acute
risk;
regulatory
action
may
be
warranted
in
addition
to
restricted
use
classification,
0.5
0.
5
Acute
Restricted
Use
there
is
potential
for
acute
risk,
but
may
be
mitigated
through
restricted
use
classification,
0.2
0.
1
Acute
Endangered
Species
endangered
species
may
be
adversely
affected;
regulatory
action
may
be
warranted,
0.1
0.
05
Chronic
Risk
there
is
potential
for
chronic
risk;
regulatory
action
may
be
warranted.
1
1
Specific
uses
chosen
for
modeling
include
non
bearing
citrus,
apples,
grapes,
walnuts,
cotton,
and
cole
crops.
Although
this
only
represents
a
portion
of
the
crops
for
which
oxyfluorfen
has
a
labeled
use,
it
does
represent
crops
with
higher
application
rates
and
crops
which
have
a
large
percentage
of
their
total
acreage
treated
with
oxyfluorfen.
By
encompassing
crops
with
large
percentages
of
acreage
treated
with
oxyfluorfen
and
a
large
geographic
area,
some
crops
with
lower
maximum
application
rates
were
also
included
in
the
set
of
scenarios.
3.
Risk
to
Terrestrial
Organisms
a.
Toxicity
(Hazard)
Assessment
Toxicity
values
for
risk
calculations
for
all
terrestrial
assessments
are
given
in
Table
16.
Toxicity
tests
with
terrestrial
species
show
that
oxyfluorfen
is
"practically
non
toxic"
to
birds
and
mammals
exposed
for
short
periods;
however,
adverse
effects
were
demonstrated
in
one
of
29
the
two
avian
reproduction
toxicity
studies
and
in
the
mammalian
sub
chronic,
chronic,
developmental,
and
2
generation
toxicity
studies.
Guideline
toxicity
tests
show
oxyfluorfen
is
"practically
non
toxic"
to
honeybees;
however,
a
non
guideline
study
demonstrated
that
an
oxyfluorfen
end
use
product
caused
almost
100%
mortality
of
predaceous
mites
at
an
application
rate
of
1.28
lbs
ai/
acre/
application.
In
general,
toxicity
tests
demonstrate
that
oxyfluorfen
negatively
impacts
seedling
emergence
and
vegetative
vigor
of
terrestrial
plants.
Table
16.
Summary
of
toxicity
values
for
terrestrial
risk
assessments
Test
Species
%
a.
i.
Endpoint
Toxicity
Category
and/
or
Most
Sensitive
Endpoint
MRID
Acute
Avian
and
Mammalian
Bobwhite
quail
(oral)
70.1
LD50
>
2150
mg
ai/
kg
bw
practically
nontoxic
921361
02
a
Bobwhite
quail
(dietary)
70.2
LC50
>
5000
mg
ai/
kg
diet
practically
nontoxic
921361
03
Laboratory
rat
(dietary)
97.1
LD50
>
5000
mg
ai/
kg
bw
practically
nontoxic
447120
10
Chronic
(reproductive)
Avian
and
Mammalian
Bobwhite
quail
72.5
NOAEC
<50
mg
ai/
kg
diet
LOAEC
=
50
mg
ai/
kg
diet
Reduced
body
weight
of
14
day
chicks
4153012
06
Laboratory
rat
71.4
NOAEC
=
400
mg
ai/
kg
diet
LOAEC
=
1600
mg
ai/
kg
diet
Parental
=
mortality,
decreased
BW
and
liver
and
kidney
histopathology
Reproductive
=
decreased
BW
and
decreased
number
of
live
pups/
litter
420149
01
Non
Target
Insects
Honey
bee
71.4
LD50
>
100
µ
g/
bee
practically
non
toxic
423681
01
Terrestrial
Plants
Seedling
EmergenceMonocot
71.5
EC25
=
0.0058
lbs
ai/
acre
shoot
length
(ryegrass)
416440
01
Seedling
Emergence
Dicot
71.5
EC25
=
0.0026
lbs
ai/
acre
shoot
length
(cabbage)
416440
01
Vegetative
Vigor
Monocot
71.5
EC25
=
0.0062
lbs
ai/
acre
shoot
weight
(onion)
416440
01
Vegetative
Vigor
Dicot
71.5
EC25
=
0.00043
lbs
ai/
acre
shoot
weight
(tomato)
416440
01
a
Also
reviewed
under
MRID
422559
01.
b.
Exposure
and
Risk
For
pesticides
applied
as
liquids,
the
estimated
environmental
concentrations
(EECs)
on
food
items
following
product
application
are
compared
to
LC50
values
to
assess
risk
with
a
Risk
Quotient
(RQ)
method.
For
birds
and
mammals,
estimates
of
maximum
residue
levels
of
oxyfluorfen
on
wildlife
food
was
based
on
the
model
of
Hoerger
and
Kenega
(1972),
as
modified
by
Fletcher
et
al.
(1994).
EECs
resulting
from
multiple
applications
are
calculated
from
the
maximum
number
of
applications,
minimum
application
interval,
and
foliar
half
life
data.
The
Agency
does
not
calculate
assess
chronic
risk
from
granular
applications.
For
terrestrial
and
semi
aquatic
plants,
the
exposure
model
incorporates
runoff
and
spray
drift.
30
RQs
were
not
calculated
to
evaluate
the
potential
acute
risks
to
birds
and
mammals
because
no
adverse
effects
reflecting
a
single
dose
were
identified
at
the
highest
dose.
For
the
current
labeled
application
rates,
minimal
acute
risks
to
birds
and
mammals
are
anticipated.
Subchronic
and
chronic
risks
to
terrestrial
birds
and
mammals
do
present
a
concern.
Assuming
maximum
residue
values,
the
chronic
LOC
of
1.0
is
exceeded
for
birds
consuming
short
grass
when
oxyfluorfen
is
applied
to
crops
at
application
rates
greater
than
or
equal
to
0.25
lbs
ai/
acre/
year.
The
chronic
RQs
are
lower
for
birds
consuming
other
food
stuffs,
but
there
are
chronic
exceedences
at
higher
application
rates.
Since
the
NOEC
in
the
chronic
avian
toxicity
study
was
not
determined
(<
50
mg
ai/
kg
diet),
the
RQs
represent
a
lower
bound.
Consumption
of
short
grass
leads
to
the
highest
chronic
risk
estimates
for
birds.
Table
17.
Summarized
Chronic
Avian
Risk
Quotients
for
Spray
Applications
a
Crop
(Site)
Max
Single
App.
Rate
(
lbs
ai/
A)
Max
No.
of
Apps.
Chronic
RQs
for
Predicted
Max
Residue
Levels
Fruits,
pods,
seeds,
large
insects
Broadleaf
forage,
small
insects
Tall
grass
Short
grass
Citrus
(Florida)
2.
0
2
>0.9
>8.4+
>6.8+
>14.9+
Apples
(Oregon)
Walnut
(California)
Grapes
(New
York)
2.0
1
>0.6
>5.4+
>4.4+
>9.6+
Cotton
(Mississippi)
Cole
crops
(California)
0.5
1
>0.2
>1.4+
>1.1+
>2.4+
Cole
crops
(California)
0.25
1
>0.1
>0.7
>0.6
>1.2+
+
indicates
an
exceedence
of
Chronic
LOC
a
Chronic
toxicity
threshold
(NOEC)
was
<50
mg
ai/
kg
diet;
Chronic
LOC
=
1.0.
For
mammals,
chronic
risk
quotients
are
estimated
to
exceed
the
Chronic
LOC
of
1.0
for
the
citrus
scenario
with
the
highest
application
rate
(2
lbs
ai/
acre,
2
applications/
season)
and
for
all
scenarios
with
a
2
lb
ai/
acre/
year
application
rate
(chronic
RQs
#
2).
Multiple
applications
of
a
pesticide
may
raise
the
risk
to
an
organism
by
increasing
the
concentration
of
residues
on
food
items
and
by
extending
the
period
during
which
these
residues
may
be
present.
31
Table
18.
Summarized
Chronic
Mammalian
Risk
Quotients
for
Spray
Applications
a
Crop
(Site)
Max
Single
App.
Rate
(
lbs
ai/
A)
Max
No.
of
Apps.
Chronic
RQs
for
Predicted
Max
Residue
Levels
Seeds
Broadleaf
forage,
small
insects
Short
grass
Citrus
(Florida)
2.
0
2
0.12
1.05
1.86+
Apples
(Oregon)
Walnut
(California)
Grapes
(New
York)
2.0
1
0.08
0.68
1.20+
Cotton
(Mississippi)
Cole
crops
(California)
0.5
1
0.
02
0.
17
0.
30
Cole
crops
(California)
0.25
1
0.
01
0.
09
0.
15
+
indicates
an
exceedence
of
the
Chronic
Risk
LOC.
a
Chronic
toxicity
threshold
(NOEC)
was
400
mg
ai/
kg
diet.
The
Agency
currently
does
not
quantify
risks
to
terrestrial
non
target
insects;
therefore,
risk
quotients
are
not
calculated
for
these
organisms.
As
a
herbicide,
oxyfluorfen
is
expected
and
has
been
shown
to
negatively
impact
seedling
emergence
and
vegetative
vigor
of
terrestrial
plants.
For
nearly
all
modeled
scenarios,
the
acute
risk
LOC
of
1.0
for
terrestrial
plants
adjacent
to
treated
areas
and
plants
in
semi
aquatic
areas
is
exceeded.
The
RQs
range
from
1
to
169.
The
risk
assessment
for
terrestrial
plants
was
based
on
RQs
calculated
from
toxicity
studies
using
the
technical
grade
of
oxyfluorfen
instead
of
a
typical
end
use
product
(TEP).
Often
the
TEPs
include
surfactants
or
adjuvants
to
increase
the
herbicide's
adsorption
into
the
plant,
thereby
increasing
its
efficacy.
If
the
toxicity
tests
were
conducted
using
a
TEP
of
oxyfluorfen
(e.
g.,
Goal
2XL)
at
the
same
rates
as
the
technical
grade,
the
toxicity
endpoints
may
be
much
lower.
Furthermore,
if
the
toxicity
endpoints
were
reduced
with
the
TEP,
the
RQs
and
the
risks
would
be
higher
than
currently
estimated.
Table
19.
Summarized
Acute
Non
endangered
Terrestrial
Plant
Risk
Quotients
Crop
Application
Rate
(lbs
ai/
acre)
Acute
RQs
Adjacent
to
treated
sites
Semi
aquatic
areas
Citrus
2
lbs
ai/
acre,
2
applications/
year
6
93
6
169
Apples,
Walnuts,
Grapes
2
lbs
ai/
acre,
1
application/
year
3
47
3
85
Cotton
(aerial)
0.5
lbs
ai/
acre,
1
application/
year
4
58
4
58
Cole
crops
(aerial)
0.25
lbs
ai/
acre,
1
application/
year
2
30
2
30
4.
Uncertainties
in
Terrestrial
Risk
Assessment
There
are
a
number
of
areas
of
uncertainty
in
the
terrestrial
risk
assessment.
Sensitivity
differences
between
species
can
be
considerable
(even
up
to
two
orders
of
magnitude)
for
some
chemicals.
The
rank
of
the
tested
species
relative
to
the
distribution
of
all
species'
sensitivities
to
oxyfluorfen
is
unknown.
In
addition,
the
toxicity
of
oxyfluorfen
to
wild
(non
laboratory)
species
relative
to
laboratory
species
is
unknown.
32
The
risk
assessment
only
considered
a
subset
of
possible
use
scenarios.
It
is
possible
that
some
of
the
labeled
uses
that
were
not
modeled
will
have
a
greater
risk
to
the
environment
than
those
included
in
this
risk
assessment.
For
example,
coffee,
cacao,
and
ornamentals
have
a
higher
seasonal
maximum
application
rate
than
those
modeled.
There
is
uncertainty
in
the
Chronic
RQ
estimates
for
birds
because
a
NOEC
was
not
established
in
the
study
used
for
risk
assessment.
The
true
magnitude
of
the
RQs
for
chronic
avian
toxicity
is
unknown,
as
these
represent
lower
bound
estimates.
Only
dietary
exposure
is
included
in
the
exposure
assessment.
Other
exposure
routes
are
possible
for
animals
in
treated
areas.
These
routes
include
ingestion
of
contaminated
drinking
water,
ingestion
of
contaminated
soils,
preening/
grooming,
dermal
contact,
and
inhalation.
5.
Risk
to
Aquatic
Animals
a.
Toxicity
(Hazard)
Assessment
Toxicity
values
for
risk
calculations
for
all
aquatic
assessments
are
given
in
Table
20.
Based
on
toxicity
studies
with
aquatic
species
submitted
by
the
registrant,
oxyfluorfen
is
"highly
toxic"
to
fish
exposed
for
short
or
extended
periods
of
time,
"very
highly
toxic"
to
"moderately
toxic"
to
aquatic
invertebrates
exposed
for
short
or
extended
periods
of
time,
and
"highly
toxic"
to
aquatic
plants.
Table
20.
Summary
of
toxicity
values
for
aquatic
risk
assessments.
Test
Species
%
a.
i.
Endpoint
Toxicity
Category
and/
or
Most
Sensitive
Endpoint
MRID
Acute
Freshwater
Bluegill
Sunfish
94.0
96
hr
LC50
=
200
µg/
L
Highly
toxic
Acc.
95583
Daphnia
magna
23.2
48
hr
EC50
=
80
µg/
L
Very
highly
toxic
Acc.
96881
Acute
Estuarine/
Marine
Sheepshead
Minnow
71.4
96
hr
LC50
>
170
µg/
L
Highly
toxic
416988
01
Grass
shrimp
74.0
96
hr
LC50
=
32
µg/
L
Very
highly
toxic
309701
17
Chronic
Freshwater
Fathead
Minnow
71
NOAEC
=
38
µg/
L
LOAEC
=
74
µg/
L
Survival,
larval
length
and
weight
921360
57
a
Daphnia
magna
71.8
NOAEC
=
13
µg/
L
LOAEC
=
28
µg/
L
growth
(length),
reproduction
421423
05
b
Aquatic
Plants
Selenastrum
capricornutum
23.2
96
hr
EC50
=
0.29
µg/
L
reduction
in
growth
452713
02
a
Also
reviewed
under
Acc.
99270.
b
Raw
data
submitted
under
MRID
455502
01.
b.
Exposure
and
Risk
For
exposure
to
aquatic
animals,
EPA
considers
surface
water
only
since
most
organisms
are
not
found
in
ground
water.
Surface
water
models
are
used
to
estimate
exposure
to
freshwater
33
aquatic
animals
since
monitoring
data
are
generally
not
targeted
studies
on
small
water
bodies
and
primary
streams
where
many
aquatic
animals
are
found.
The
modeling
results
used
in
risk
calculations
are
detailed
in
the
EFED
chapter.
The
Agency
used
PRZM
EXAMS
to
calculate
refined
EECs.
The
Pesticide
Root
Zone
Model
(PRZM,
version
3.12)
simulates
pesticides
in
field
runoff
and
erosion,
while
the
Exposure
Analysis
Modeling
System
(EXAMS,
version
2.7.95)
simulates
pesticide
fate
and
transport
in
an
aquatic
environment
(one
hectare
body
of
water,
two
meters
deep).
EECs
were
calculated
for
surface
water
using
the
highest
application
rate
on
non
bearing
citrus,
apples,
grapes,
walnuts,
cotton,
and
cole
crops.
Although
this
only
represents
a
portion
of
the
crops
for
which
oxyfluorfen
has
a
labeled
use,
it
does
represent
crops
with
higher
application
rates
and
crops
which
have
a
large
percentage
of
their
total
acreage
treated
with
oxyfluorfen.
By
encompassing
crops
with
large
percentages
of
acreage
treated
with
oxyfluorfen
and
a
large
geographic
area,
some
crops
with
lower
maximum
application
rates
were
also
included
in
the
set
of
scenarios.
For
freshwater
and
estuarine
fish,
the
acute
and
chronic
risk
LOCs
are
not
exceeded.
For
freshwater
invertebrates,
the
acute
risk
LOC
of
0.5
is
exceeded
for
two
citrus
scenarios
with
higher
application
rates
(RQs
#
0.62).
For
estuarine
invertebrates,
the
acute
risk
LOC
of
0.5
is
exceeded
for
all
citrus
scenarios
(RQs
#
1.56).
Though
oxyfluorfen
is
highly
toxic
to
all
fish
and
invertebrate
species
tested,
the
RQs
calculated
from
EECs
derived
from
Tier
II
simulations
suggest
little
potential
for
acute
risk
to
fish
or
invertebrates.
Of
the
scenarios
modeled,
there
were
no
Chronic
Risk
LOC
exceedences
for
freshwater
fish.
For
freshwater
invertebrates,
the
Chronic
LOC
was
exceeded
in
all
Florida
citrus
scenarios
and
for
the
maximum
application
rate
on
New
York
grapes.
Table
21.
Acute/
Chronic
Risk
Quotients
for
Aquatic
Species
Crop
(Site)
Max
Single
App.
Rate
(
lbs
ai/
A)
Max
No.
of
Apps./
Method
Type
Freshwater
Estuarine/
Marine
Acute
RQ
Chronic
RQ
Acute
RQ
Fish
Invert.
Fish
Invert.
Invert.
Citrus
(Florida)
2.
0
2/
ground
0.25**
0.62***
0.67
2.35+
1.56***
Apples
(Oregon)
2.0
1/
ground
0.04
0.10**
0.10
0.38
0.25**
Grapes
(New
York)
2.
0
1/
ground
0.10**
0.25**
0.33
1.11+
0.61***
Walnut
(California)
2.0
1/
ground
0.02
0.04
0.11
0.82
0.10*
Cotton
(Mississippi)
0.
5
1/
aerial
1/
ground
0.02
0.06*
0.06*
0.08
0.09
0.29
0.27
0.15**
0.14**
Cole
crops
(California)
0.25
1/
aerial
1/
ground
0.01
0.02
0.02
0.08
0.06
0.05*
0.04
*
indicates
an
exceedence
of
Endangered
Species
LOC
**
indicates
an
exceedence
of
Acute
Restricted
Use
LOC
***
indicates
an
exceedence
of
Acute
Risk
LOC
+
indicates
an
exceedence
of
Chronic
LOC
34
Limited
monitoring
data
provide
further
information
for
the
evaluation
of
environmental
risk
to
aquatic
organisms.
Based
on
sampling
during
February
1992
in
the
San
Joaquin
River,
oxyfluorfen
concentrations
in
water
were
estimated
to
be
between
0.1
and
1.0
:
g/
L.
Using
1.0
:
g/
L
as
an
EEC,
the
Acute
Risk
LOC
was
exceeded
for
aquatic
plants
(RQ
=
3.45),
but
there
were
no
acute
LOC
exceedences
for
freshwater
fish
(RQ
<
0.01)
and
invertebrates
(RQ
=
0.01),
and
estuarine
fish
(RQ
<
0.01)
and
invertebrates
(RQ
=
0.03).
Long
term
sampling
at
four
sites
had
estimated
average
concentrations
of
oxyfluorfen
in
water
ranging
from
0.01
to
0.27
:
g/
L,
indicating
a
lower
risk
to
aquatic
organisms;
however,
localized
high
concentrations
of
oxyfluorfen
have
been
observed.
As
a
result
of
the
Goal
2XL
spill
in
the
Columbia
River
Basin
(Fifteen
Mile
Creek)
on
August
24,
2000,
focused
sediment
and
water
sampling
was
conducted.
Water
and
sediment
samples
were
collected
as
background
measures
from
areas
thought
not
to
be
impacted
by
the
spill.
The
few
background
water
samples
did
not
have
detectable
amounts
of
oxyfluorfen,
but
2
of
the
35
background
sediment
samples
did
have
detectible
amounts
of
oxyfluorfen
(the
highest
was
541
ppb).
It
is
important
to
note
that
these
background
samples
were
collected
seven
months
after
most
oxyfluorfen
applications
would
have
occurred
(oxyfluorfen
is
primarily
applied
during
the
dormant
winter
season).
6.
Risk
to
Aquatic
Plants
The
RQs
for
all
modeled
scenarios
currently
exceed
the
acute
risk
LOC
of
1.0
for
freshwater
algal
plants,
and
range
from
5
to
172.
Risks
to
aquatic
vascular
plants
cannot
be
assessed
at
this
time
since
no
data
have
been
submitted.
Table
22.
Acute
Risk
Quotients
for
Aquatic
Plants*
Crop
(Site)
Max
Single
App.
Rate
(
lbs
ai/
A)
Max
No.
of
Apps./
Method
Type
Freshwater
algae
(Nonvascular)
Acute
RQ
Citrus
(Florida)
2.
0
2/
ground
171.59
Apples
(Oregon)
2.0
1/
ground
28.38
Grapes
(New
York)
2.
0
1/
ground
67.59
Walnut
(California)
2.0
1/
ground
44.72
Cotton
(Mississippi)
0.5
1/
aerial
1/
ground
16.72
15.31
Cole
crops
(California)
0.25
1/
aerial
1/
ground
5.45
4.59
*
Acute
toxicity
for
Aquatic
Plants
(The
plant
growth
study
on
Selenastrum
capricornutum
(MRID
452713
02)
with
Goal
2XL
indicated
a
96
hr
EC50
of
0.29
ppb
at
23.2
%
ai,
classifying
oxyfluorfen
as
"highly
toxic")
a.
Uncertainties
in
the
Aquatic
Assessment
There
are
a
number
of
areas
of
uncertainty
in
the
aquatic
organism
risk
assessment.
The
risk
assessment
only
considers
the
most
sensitive
species
tested.
The
position
of
the
tested
species
relative
to
the
distribution
of
all
species'
sensitivities
to
oxyfluorfen
is
unknown.
The
aquatic
plant
risk
assessment
is
based
on
only
one
species,
a
freshwater
algae.
There
is
a
large
uncertainty
because
the
response
of
non
vascular
plants
to
oxyfluorfen
may
be
different
than
the
response
of
the
vascular
plants
to
oxyfluorfen.
The
risk
assessment
only
considered
a
subset
of
35
possible
use
scenarios.
Some
of
the
labeled
uses
that
were
not
modeled
may
have
a
greater
risk
to
the
environment
than
those
included
in
this
risk
assessment.
No
chronic
toxicity
studies
for
estuarine
fish
or
invertebrates
were
submitted
to
the
Agency,
so
the
toxicity
of
oxyfluorfen
to
these
organisms
is
unknown.
Aquatic
risks
have
not
been
assessed
for
a
myriad
of
aquatic
habitats
(e.
g.,
marshes,
streams,
intermittent
aquatic
areas)
which
are
more
extensive
and
are
frequently
more
productive
than
2
meter
deep
ponds.
The
benthic
environment
(aquatic
soil
environment)
provides
habitat
to
many
invertebrates
that
provide
important
food
sources
to
fish
and
other
aquatic
organisms.
Based
on
toxicity
data
to
invertebrates,
oxyfluorfen
may
pose
long
term
effects
to
benthic
organisms.
Because
of
oxyfluorfen's
high
affinity
to
soil,
soil
eroding
from
application
areas
is
likely
to
carry
bound
oxyfluorfen
to
aquatic
areas.
Guideline
studies
for
aerobic
and
anaerobic
soil
metabolism
suggest
oxyfluorfen
is
highly
persistent
on
soil
and
would
likely
accumulate
in
depositing
sediments.
This
information,
combined
with
oxyfluorfen
measurements
in
river
suspended
sediment
and
aquatic
toxicity
data,
suggests
benthic
organisms
may
be
impacted
and
aquatic
habitat
degraded
as
a
result
of
oxyfluorfen
usage.
EPA
is
requesting
a
10
day
survival
and
growth
toxicity
test
for
sediments
using
freshwater
sediment
toxicity
organisms.
Oxyfluorfen
may
pose
risks
to
animals
not
conveyed
by
standard
guideline
toxicity
studies
because
oxyfluorfen's
mode
of
action
suggests
it
may
be
more
toxic
in
the
presence
of
light
(phototoxic).
Oxyfluorfen,
and
other
light
dependent
peroxidizing
herbicides,
act
in
plants
by
producing
phototoxic
compounds.
Toxicity
studies
with
oxyfluorfen
and
other
similar
herbicides
suggest
the
same
phototoxic
compounds
may
occur
in
animals
as
a
result
of
herbicide
exposure.
Because
guideline
toxicity
studies
are
normally
conducted
under
relatively
low,
artificial
light
conditions,
the
effects
of
being
exposed
simultaneously
to
oxyfluorfen
and
sunlight
are
not
known.
To
provide
information
on
the
magnitude
of
this
effect,
EPA
is
requesting
fish
phototoxicity
studies
be
conducted
for
oxyfluorfen.
7.
Endangered
Species
The
preliminary
risk
assessment
for
endangered
species
indicates
that
oxyfluorfen
exceeds
the
endangered
species
LOCs
for
the
following
combinations
of
analyzed
uses
and
species:
°
terrestrial
plants
for
all
uses;
°
avian
chronic
for
non
bearing
citrus
and
all
applications
with
rates
greater
than
0.5
lb
ai/
acre/
application
(such
as
rights
of
way,
apples,
walnuts
and
grapes)
based
on
both
maximum
and
mean
residue
levels;
°
mammalian
chronic
for
non
bearing
citrus,
and
applications
with
rates
of
2
lbs
ai/
acre
(such
as
rights
of
way,
apples,
walnuts
and
grapes)
based
on
maximum
residues;
°
freshwater
fish
for
non
bearing
citrus
and
grapes
(of
those
scenarios
modeled);
and
°
estuarine
fish
for
non
bearing
citrus,
apples
and
grapes
(of
those
scenarios
modeled);
and
°
freshwater
invertebrates
for
non
bearing
citrus,
apples,
grapes
and
cotton
(of
those
scenarios
modeled).
36
Although
the
endangered
species
LOC
for
estuarine
invertebrates
has
been
exceeded,
there
are
no
federally
listed
species
in
this
group.
Risks
to
endangered
aquatic
vascular
plants
cannot
be
assessed
at
this
time
since
no
acceptable
toxicity
test
for
Lemna
gibba
has
been
submitted
to
the
Agency.
Further
analysis
regarding
the
overlap
of
individual
species
and
their
behavior
with
each
use
site
is
required
prior
to
determining
the
likelihood
of
potential
impact
to
listed
species.
The
Agency
had
a
consultation
in
1985
(amended
in
1986)
with
the
US
Fish
and
Wildlife
Service
(FWS
or
the
Service)
on
oxyfluorfen
(Goal
1.6E
and
Goal
2E)
regarding
its
use
on
noncrop
areas
including
rights
of
ways,
fence
rows,
roadsides,
and
levee
banks.
The
Service
found
jeopardy
to
76
species
of
endangered
plants,
54
species
of
endangered
fish,
23
species
of
endangered
mussels
(clams),
two
species
of
snails,
eleven
species
of
endangered
insects,
four
endangered
amphibians
and
one
endangered
bird
(piping
plover).
The
Service
proposed
a
Reasonable
and
Prudent
Alternatives
(RPA)
to
avoid
jeopardy
to
these
species.
The
RPA
prohibited
the
application
of
Goal
within
a
quarter
mile
of
the
habitat
of
the
listed
plants
and
terrestrial
invertebrates
and
within
a
quarter
mile
of
the
streams
or
bodies
of
water
where
the
aquatic
species
occur.
Oxyfluorfen
was
included
in
the
corn
cluster
consultation
in
1983,
and
it's
uses
on
crops
and
forests
were
also
included
in
the
"reinitiation"
of
clusters
in
1988.
The
resulting
1989
opinion
found
jeopardy
to
one
amphibian
(the
Wyoming
toad
which
is
extirpated
in
the
wild
except
on
FWS
refuges),
five
fish
species,
two
species
of
crustaceans
and
one
bird
species
(the
wood
stork).
The
Service
proposed
Reasonable
and
Prudent
Alternatives
(RPA)
for
each
of
these
jeopardized
species.
In
addition,
the
Service
had
Reasonable
and
Prudent
Measures
(RPM)
to
reduce
incidental
take
of
34
aquatic
and
three
bird
species.
The
details
of
the
RPM
recommendations
are
provided
in
the
FWS
1989
biological
opinion.
Acute
risks
to
endangered
birds
is
no
longer
a
concern
for
oxyfluorfen,
as
the
study
used
as
the
basis
for
the
earlier
findings
of
jeopardy
to
birds
has
since
been
determined
to
be
invalid.
However,
many
additional
species,
especially
aquatic
species,
have
been
federally
listed
as
endangered/
threatened
since
the
biological
opinion
of
1989
was
written,
and
determination
of
potential
effect
to
these
species
has
not
been
assessed
for
oxyfluorfen.
In
addition,
endangered
plants,
which
were
considered
in
the
1985
and
1986
biological
opinions
for
the
rights
of
way
uses,
were
not
considered
in
the
1989
opinion
and
need
to
be
addressed.
Finally,
not
only
are
more
refined
methods
to
define
ecological
risks
of
pesticides
being
used
but
also
new
data,
such
as
that
for
spray
drift,
are
now
available
that
did
not
exist
in
1989.
The
RPAs
and
RPMs
in
the
1989
opinion
may
need
to
be
reassessed
and
modified
based
on
these
new
approaches.
The
Agency
is
currently
engaged
in
a
Proactive
Conservation
Review
with
FWS
and
the
National
Marine
Fisheries
Service
under
section
7(
a)(
1)
of
the
Endangered
Species
Act
to
clarify
and
develop
consistent
processes
for
endangered
species
risk
assessments
and
consultations.
Subsequent
to
the
completion
of
this
process,
the
Agency
will
reassess
both
those
species
listed
since
the
completion
of
the
biological
opinion
and
those
not
considered
in
the
opinion.
The
Agency
will
also
consider
regulatory
changes
implemented
in
this
RED
when
the
reassessment
is
undertaken.
37
8.
Ecological
Incidents
There
is
one
reported
incident
in
the
EIIS
database
with
an
aquatic
organism
effect.
On
August
22,
2000,
Fifteen
Mile
Creek
near
the
Dalles
Dam
in
Oregon
was
the
site
of
an
oxyfluorfen
spill.
A
truck
carrying
formulated
oxyfluorfen
(Goal
2XL)
crashed
on
a
bridge
spilling
approximately
20,000
gallons
of
herbicide
into
the
creek
yards
from
where
the
creek
enters
the
Columbia
River.
Two
weeks
after
the
spill,
samples
of
filtered
and
unfiltered
water
near
the
spill
site
contained
an
average
of
32
:
g/
L
and
340
:
g/
L,
respectively.
This
spill
was
estimated
to
cause
a
35%
decrease
in
the
numbers
of
adult
chinook
salmon
and
a
26%
decrease
in
the
numbers
of
steelhead
passing
over
the
Dalles
Dam
the
day
immediately
following
the
spill,
relative
to
the
day
prior
to
the
spill.
The
spill
was
also
reported
to
kill
thousands
of
young
lampreys.
An
extensive
cleanup
operation
(removal
of
water
and
sediment)
removed
a
majority
of
the
chemical,
and
the
estimated
quantity
of
oxyfluorfen
not
recovered
was
less
than
1000
gallons.
There
are
several
reported
plant
incidents
in
the
Environmental
Incident
Information
System
(EIIS)
database.
One
incident
occurred
on
March
7,
1996,
when
a
pest
control
operator
in
Madera
County,
California,
applied
Roundup
(glyphosate)
and
Goal
(oxyfluorfen)
to
an
unspecified
site.
These
herbicides
drifted
to
40
acres
of
plums
and
90
100
acres
of
almonds
with
total
damage
estimated
at
$520,000
to
$760,000.
A
similar
incident
occurred
in
1996
in
Arkansas.
A
grower
stated
that
aerial
drift
of
Roundup
Ultra
and
Goal
damaged
160
acres
of
rice,
and
80
acres
had
to
be
replanted.
Another
aerial
drift
incident
occurred
in
1996
in
California.
A
grower
stated
that
aerial
drift
of
Roundup
Ultra
and
Goal
damaged
10
acres
of
oranges.
Investigation
by
Monsanto
representatives
revealed
that
adequate
buffer
zones
had
not
been
employed.
In
these
cases,
either
of
these
compounds
may
have
contributed
to
the
damage
of
these
crops.
There
are
2
reported
incidents
of
damage
attributed
to
a
home
use
product
(Ortho
GroundClear
Triox).
Both
incidents
involved
damage
and
death
to
small
numbers
of
ornamentals
and
juniper
trees.
The
damage
may
have
been
caused
by
oxyfluorfen
and/
or
the
other
active
ingredient
in
Triox,
isopropylamine
salt.
The
lack
of
reported
incidents
to
birds,
mammals,
and
aquatic
species
cannot
be
considered
as
evidence
of
lack
of
risk.
For
example,
the
major
concerns
for
risks
to
birds
and
mammals
are
chronic
effects.
If
oxyfluorfen
is
having
a
chronic
impact
to
bird
and
mammal
populations
in
the
wild,
observance
of
these
effects
is
much
less
likely
than
if
the
risks
of
concern
were
acute
effects
(e.
g.,
mortality).
IV.
Risk
Management
and
Reregistration
Decision
A.
Determination
of
Reregistration
Eligibility
Section
4(
g)(
2)(
A)
of
FIFRA
calls
for
the
Agency
to
determine,
after
submissions
of
relevant
data
concerning
an
active
ingredient,
whether
products
containing
the
active
ingredient
38
are
eligible
for
reregistration.
The
Agency
has
previously
identified
and
required
the
submission
of
the
generic
(i.
e.,
an
active
ingredient
specific)
data
required
to
support
reregistration
of
products
containing
the
active
ingredient
oxyfluorfen.
The
Agency
has
completed
its
assessment
of
the
occupational,
non
occupational,
and
ecological
risks
associated
with
the
use
of
pesticide
products
the
active
ingredient
oxyfluorfen,
as
well
as
an
oxyfluorfen
specific
dietary
risk
assessment.
Based
on
a
review
of
these
data
and
on
public
comments
on
the
Agency's
assessments
for
the
active
ingredient
oxyfluorfen,
EPA
has
sufficient
information
on
the
human
health
and
ecological
effects
of
oxyfluorfen
to
make
decisions
as
part
of
the
tolerance
reassessment
process
under
FFDCA
and
reregistration
process
under
FIFRA,
as
amended
by
FQPA.
The
Agency
has
determined
that
oxyfluorfen
products
are
eligible
for
reregistration
provided
that:
(i)
current
data
gaps
and
additional
confirmatory
data
needs
are
addressed;
(ii)
the
risk
mitigation
measures
outlined
in
this
document
are
adopted,
and
(iii)
label
amendments
are
made
to
reflect
these
measures.
Label
changes
are
described
in
Section
V.
Appendix
A
summarizes
the
uses
of
oxyfluorfen
that
are
eligible
for
reregistration.
Appendix
B
identifies
the
generic
data
requirements
that
the
Agency
reviewed
as
part
of
its
determination
of
reregistration
eligibility
of
oxyfluorfen,
and
lists
the
submitted
studies
that
the
Agency
found
acceptable.
Data
gaps
are
identified
as
generic
data
requirements
that
have
not
been
satisfied
with
acceptable
data.
Based
on
its
evaluation
of
oxyfluorfen,
the
Agency
has
determined
that
oxyfluorfen
products,
unless
labeled
and
used
as
specified
in
this
document,
would
present
risks
inconsistent
with
FIFRA.
Accordingly,
should
a
registrant
fail
to
implement
any
of
the
risk
mitigation
measures
identified
in
this
document,
the
Agency
may
take
regulatory
action
to
address
the
risk
concerns
from
use
of
oxyfluorfen.
If
all
changes
outlined
in
this
document
are
incorporated
into
the
product
labels,
then
all
current
risks
for
oxyfluorfen
will
be
adequately
mitigated
for
the
purposes
of
this
determination.
B.
Public
Comments
and
Responses
When
making
its
reregistration
decision,
the
Agency
took
into
account
all
comments
received
after
opening
of
the
public
docket.
These
comments
in
their
entirety
are
available
in
the
docket
(OPP
#34252).
Comments
on
the
risk
assessment
were
submitted
by
two
registrants,
Dow
AgroSciences
and
the
Scotts
Company.
EPA
also
received
letters
from
approximately
65
growers,
extension
agents,
and
commodity
organizations
attesting
to
the
importance
of
oxyfluorfen
to
their
weed
control
programs
for
commodities
such
as
forest
seedlings,
grapes,
artichokes,
various
brassica
and
crucifer
crops,
Christmas
trees,
raspberries,
blackberries,
garbanzo
beans,
onions,
ornamentals,
various
orchard
crops,
garlic,
walnuts,
and
almonds.
The
majority
of
comments
were
submitted
by
the
forestry
and
nursery
industries,
which
point
out
that
oxyfluorfen
is
one
of
the
most
important,
if
not
the
most
important,
pesticides
used
for
weed
control
based
on
its
cost
effectiveness
and
efficacy.
The
Oregon
Strawberry
Commission
submitted
a
comment
regarding
their
pending
Section
3
petition
for
use
of
oxyfluorfen
on
strawberries.
Strawberry
growers
have
used
oxyfluorfen
(Goal
2XL)
under
the
Section
18
Emergency
Exemption
Program
from
1997
2001.
39
The
Confederated
Tribes
of
the
Warm
Springs
Reservation
of
Oregon
raised
concern
that
the
dietary
risk
assessment
for
oxyfluorfen
is
not
protective,
because
estimated
fish
consumption
was
based
on
an
amount
representative
of
the
general
public
rather
than
subpopulations
which
may
consume
higher
levels
of
fish.
EPA
did
not
address
this
comment
in
the
Response
to
Comments
documents,
so
this
comment
is
being
addressed
here.
The
fish
bioconcentration
study
suggests
that
accumulation
would
occur,
but
residues
would
depurate
rapidly
when
fish
move
to
clean
water.
In
contrast,
the
fish
monitoring
data
from
the
Columbia
river
(gathered
as
a
part
of
the
oxyfluorfen
spill
incident)
suggests
a
slower
depuration
period.
The
fish
in
the
Columbia
River
were
not
sediment
dwelling
but
frequently
contained
residues
greater
than
10
ppb
and
a
couple
of
instances
over
100
ppb.
It
is
uncertain
whether
or
not
residues
were
caused
by
the
spill
because
the
fish
were
collected
either
upstream
or
many
miles
downstream.
These
measurements
in
the
Columbia
River
are
useful
in
defining
bioaccumulation
potential
since
they
were
collected
in
the
field
and
represent
a
variety
of
fish
(including
those
eaten
by
tribes
and
recreational
anglers).
The
Columbia
River
results
do
suggest
that
oxyfluorfen
has
the
potential
to
accumulate
in
fish
in
the
environment
to
a
certain
extent.
The
Office
of
Pesticide
Programs
has
provided
the
information
relevant
to
potential
oxyfluorfen
accumulation
in
fish
to
the
Office
of
Water
who
will
determine
if
state
advisory
actions
and/
or
additional
monitoring
programs
are
needed.
The
Office
of
Pesticide
Programs
will
continue
to
work
with
the
Office
of
Water
to
ensure
that
potential
exposures
and
risks
are
appropriately
assessed.
Formal
Agency
responses
to
comments
related
to
the
risk
assessments
can
be
found
in
the
following
documents,
which
are
available
in
the
public
docket:
"Oxyfluorfen:
Response
to
Public
Comments
to
the
Human
Health
Risk
Assessment"
dated
May
1,
2002;
"Oxyfluorfen:
Response
to
the
Occupational/
Residential
Exposure
(ORE)
Comments
Submitted
in
Response
to
the
60
Day
Public
Comment
Period"
dated
May
2,
2002;
and
"Environmental
Fate
and
Effects
Division
Response
to
Public
Comments
Made
by
Dow
AgroSciences
and
the
California
Almond
Board
on
EFED's
Risk
Assessment
for
Oxyfluorfen"
dated
May
2,
2002.
C.
Regulatory
Position
1.
FQPA
Assessment
a.
"Risk
Cup"
Determination
As
part
of
the
FQPA
tolerance
reassessment
process,
EPA
assessed
the
risks
associated
with
this
pesticide.
EPA
has
determined
that
risk
from
dietary
(food
sources
only)
exposure
to
oxyfluorfen
is
within
its
own
"risk
cup."
In
other
words,
EPA
has
concluded
that
the
tolerances
for
oxyfluorfen
meet
the
FQPA
safety
standards.
In
reaching
this
determination
EPA
has
considered
the
available
information
on
the
special
sensitivity
of
infants
and
children,
as
well
as
the
acute
and
chronic
food
exposure.
An
aggregate
assessment
was
conducted
for
exposures
through
food,
drinking
water,
and
residential
uses.
The
Agency
has
determines
that
the
human
health
risks
from
these
combined
exposures
are
within
acceptable
levels.
40
Therefore,
there
are
no
changes
in
oxyfluorfen
tolerances
due
to
risk
concerns
and
most
tolerances
will
remain
in
effect;
however,
the
following
tolerance
changes
and
data
are
necessary:
Tolerances
for
field
corn
fodder
and
forage
are
not
warranted
because
oxyfluorfen's
registered
use
on
field
corn
is
limited
to
the
states
of
NC
and
SC
in
conjunction
with
a
USDA
program
to
eradicate
"witchweed"
(Striga
asiatica);
the
treated
forage
and
fodder
of
field
corn
are
not
fed
to
livestock
to
avoid
the
spread
of
the
weed.
With
respect
to
animal
commodities,
the
established
oxyfluorfen
tolerances
for
milk,
fat,
meat,
and
meat
by
products
of
cattle,
goats,
hogs,
horses,
and
sheep
should
be
lowered
from
0.05
to
0.01
ppm
based
on
the
reviewed
cattle
feeding
study.
Similarly,
adjustments
in
the
tolerance
levels
of
the
following
poultry
commodities
are
required
based
on
the
results
of
the
poultry
feeding
study:
eggs
(from
0.05
to
0.03
ppm);
meat
and
meat
by
products
(from
0.05
to
0.01
ppm);
and
fat
(from
0.05
to
0.2
ppm).
The
registrant
may
impose
label
restrictions
on
the
feeding
of
oxyfluorfen
treated
soybean
forage
and
hay
in
lieu
of
submitting
field
residue
data
and
proposing
tolerances
for
these
soybean
commodities.
The
Agency
will
establish
tolerances
for
cotton
gin
byproducts,
and
citrus
oil.
Tolerances
with
regional
registration
for
grass
forage,
grass
hay,
and
grass
seed
screenings
at
0.05
ppm
each
should
also
be
established.
The
need
to
modify
tolerances
for
bananas
and
cacao
beans
will
be
determined
upon
receipt
of
confirmatory
data.
b.
Determination
of
Safety
for
U.
S.
Population
EPA
has
determined
that
the
established
tolerances
for
oxyfluorfen,
with
amendments
and
changes
as
specified
in
this
document,
meet
the
safety
standards
under
the
FQPA
amendments
to
section
408(
b)(
2)(
D)
of
the
FFDCA,
that
there
is
a
reasonable
certainty
of
no
harm
for
the
general
population.
In
reaching
this
determination,
EPA
has
considered
all
available
information
on
the
toxicity,
use
practices,
and
scenarios,
and
the
environmental
behavior
of
oxyfluorfen.
As
discussed
in
chapter
3,
the
chronic
dietary
(food
alone)
risk
is
below
the
level
of
concern,
as
is
the
cancer
dietary
risk
from
food
alone.
Risks
from
residential
exposures
alone
are
also
below
the
level
of
concern.
Regarding
risks
from
drinking
water
exposures,
chronic
risks
from
drinking
water
are
not
of
concern
for
surface
or
groundwater
supplies.
Although
the
projected
surface
water
concentrations
exceed
the
Agency's
cancer
concern
level,
the
Agency
believes
that
those
projections
are
conservative
and
over
estimate
the
human
exposure
to
oxyfluorfen
that
will
result
from
drinking
water
sources
from
surface
water
(See
Regulatory
Rationale
under
Drinking
Water
in
section
IV.
D.
1.
a.
iv.).
c.
Determination
of
Safety
for
Infants
and
Children
EPA
has
determined
that
the
established
tolerances
for
oxyfluorfen,
with
amendments
and
changes
as
specified
in
this
document,
meet
the
safety
standards
under
the
FQPA
amendments
to
section
408(
b)(
2)(
C)
of
the
FFDCA,
that
there
is
a
reasonable
certainty
of
no
harm
for
infants
and
children.
The
safety
determination
for
infants
and
children
considers
the
factors
noted
above
for
the
general
population,
but
also
takes
into
account
the
possibility
of
41
increased
dietary
exposure
due
to
the
specific
consumption
patterns
of
infants
and
children,
as
well
as
the
possibility
of
increased
susceptibility
to
the
toxic
effects
of
oxyfluorfen
residues
in
this
population
subgroup.
In
determining
whether
or
not
infants
and
children
are
particularly
susceptible
to
toxic
effects
from
oxyfluorfen
residues,
EPA
considered
the
completeness
of
the
database
for
developmental
and
reproductive
effects,
the
nature
of
the
effects
observed,
and
other
information.
An
FQPA
safety
factor
is
not
required
for
oxyfluorfen
because:
1)
There
does
not
appear
to
be
any
increased
susceptibility
in
animals
due
to
pre
or
postnatal
exposure
to
oxyfluorfen
based
upon
the
developmental
and
reproductive
toxicity
studies
reviewed.
Although
two
does
in
the
high
dose
group
of
the
rabbit
developmental
study
aborted,
these
abortions
are
considered
secondary
to
the
debilitating
condition
(generalized,
systemic
toxicity)
of
the
mothers;
2)
Although
neurotoxicity
studies
were
not
performed,
there
was
no
indication
of
neurotoxicity
in
the
submitted
developmental
and
reproductive
studies
or
in
the
published
literature.
A
developmental
neurotoxicity
study
was
not
required;
and
3)
the
dietary
(food
and
drinking
water)
and
non
dietary
(residential)
exposure
assessments
will
not
underestimate
the
potential
exposures
for
infants
and
children.
d.
Endocrine
Disruptor
Effects
EPA
is
required
under
the
FFDCA,
as
amended
by
FQPA,
to
develop
a
screening
program
to
determine
whether
certain
substances
(including
all
pesticide
active
and
other
ingredients)
"may
have
an
effect
in
humans
that
is
similar
to
an
effect
produced
by
a
naturally
occurring
estrogen,
or
other
endocrine
effects
as
the
Administrator
may
designate."
Following
recommendations
of
its
Endocrine
Disruptor
Screening
and
Testing
Advisory
Committee
(EDSTAC),
EPA
determined
that
there
was
scientific
basis
for
including,
as
part
of
the
program,
the
androgen
and
thyroid
hormone
systems,
in
addition
to
the
estrogen
hormone
system.
EPA
also
adopted
EDSTAC's
recommendation
that
EPA
include
evaluations
of
potential
effects
in
wildlife.
For
pesticides,
EPA
will
use
FIFRA
and,
to
the
extent
that
effects
in
wildlife
may
help
determine
whether
a
substance
may
have
an
effects
in
humans,
FFDCA
authority
to
require
the
wildlife
evaluations.
As
the
science
develops
and
resources
allows,
screening
of
additional
hormone
systems
may
be
added
to
the
Endocrine
Disruptor
Screening
Program
(EDSP).
When
the
appropriate
screening
and/
or
testing
protocols
being
considered
under
the
EDSP
have
been
developed,
oxyfluorfen
may
be
subject
to
additional
screening
and/
or
testing
to
better
characterize
effects
related
to
endocrine
disruption.
e.
Cumulative
Risks
The
Food
Quality
Protection
Act
(FQPA)
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."
Oxyfluorfen
is
a
diphenyl
ether
herbicide
structurally
related
to
lactofen,
fomesafen
and
acifluorfen.
Although
chemical
class
is
not
necessarily
synonymous
42
with
a
common
mechanism
of
toxicity,
structurally
similar
chemical
substances
do
frequently
exhibit
common
modes
of
toxicity.
At
this
time,
the
Agency
has
not
made
a
decision
as
to
whether
oxyfluorfen
shares
a
common
mechanism
of
toxicity
with
these
other
diphenyl
ethers
or
any
other
pesticide.
A
careful
evaluation
of
all
the
available
data,
as
well
as
additional
data
on
the
cancer
mechanism
of
the
diphenyl
ether
herbicides
are
still
needed.
A
peer
review
by
the
FIFRA
Science
Advisory
Panel
is
also
necessary
before
a
formal
decision
is
made.
Therefore,
for
the
purposes
of
this
risk
assessment,
the
Agency
has
assumed
that
oxyfluorfen
does
not
share
a
common
mechanism
of
toxicity
with
other
pesticides.
After
a
decision
is
made
regarding
common
mechanism
of
toxicity,
and
if
the
Agency
has
determined
that
a
cumulative
assessment
is
necessary,
the
Agency
will
address
any
outstanding
risk
concerns
at
that
time.
f.
Tolerances
Summary
A
summary
of
the
oxyfluorfen
tolerance
reassessments
is
presented
in
Table
23.
In
the
assessment,
tolerances
for
residues
of
oxyfluorfen
in/
on
plant
commodities
[40
CFR
§180.381]
are
presently
expressed
in
terms
of
the
parent
only.
No
Codex
MRLs
have
been
established
for
oxyfluorfen;
therefore,
issues
of
compatibility
between
Codex
MRLs
and
U.
S.
tolerances
do
not
exist.
The
majority
of
data
indicate
that
oxyfluorfen
residues
in/
on
most
plant
commodities
were
below
the
LOQ
(<
0.01
ppm)
of
the
data
collection
method
following
application
of
oxyfluorfen
formulation(
s)
according
to
maximum
registered
uses.
At
this
time,
EPA
is
reassessing
most
plant
commodity
tolerances
at
the
established
level
of
0.05
ppm
until
an
adequate
single
analyte
enforcement
method
becomes
available.
The
need
to
modify
tolerances
for
bananas
and
cacao
beans
will
be
determined
upon
receipt
of
confirmatory
data.
The
reassessed
tolerance
for
broccoli
is
based
on
residue
data
translated
from
cabbage
and
cauliflower.
As
per
40
CFR
§180.1
a
separate
tolerance
for
garlic
is
not
needed
because
the
established
tolerance
for
dry
bulb
onions
will
apply
to
garlic.
Tolerances
for
field
corn
fodder
and
forage
are
not
warranted
because
oxyfluorfen's
registered
use
on
field
corn
is
limited
to
the
states
of
NC
and
SC
in
conjunction
with
a
USDA
program
to
eradicate
"witchweed"
(Striga
asiatica);
the
treated
forage
and
fodder
of
field
corn
are
not
fed
to
livestock
to
avoid
the
spread
of
the
weed.
With
respect
to
animal
commodities,
the
established
oxyfluorfen
tolerances
for
milk,
fat,
meat,
and
meat
by
products
of
cattle,
goats,
hogs,
horses,
and
sheep
should
be
lowered
from
0.05
to
0.01
ppm
based
on
the
reviewed
cattle
feeding
study.
Similarly,
adjustments
in
the
tolerance
levels
of
the
following
poultry
commodities
are
required
based
on
the
results
of
the
poultry
feeding
study:
eggs
(from
0.05
to
0.03
ppm);
meat
and
meat
by
products
(from
0.05
to
0.01
ppm);
and
fat
(from
0.05
to
0.2
ppm).
43
An
oxyfluorfen
tolerance
for
cotton
gin
byproducts
must
be
proposed
once
adequate
field
residue
data,
reflecting
the
maximum
registered
use
pattern,
have
been
submitted
and
evaluated.
The
registrant
may
impose
label
restrictions
on
the
feeding
of
oxyfluorfen
treated
soybean
forage
and
hay
in
lieu
of
submitting
field
residue
data
and
proposing
tolerances
for
these
soybean
commodities.
Adequate
data
are
available
to
reassess
the
established
tolerances
with
regional
registrations
for
the
following
commodities,
as
defined:
blackberry,
garbanzo
beans,
guava,
papaya,
raspberry,
and
taro
(corms
and
leaves).
Table
23.
Tolerance
Reassessment
Summary
for
Oxyfluorfen.
Commodity
Current
Tolerance
(ppm)
Tolerance
Reassessment
(ppm)
Comment/
[Correct
Commodity
Definition]
Tolerances
Listed
Under
40
CFR
§180.381
(a):
Almond
hulls
0.1
0.
1
[Almond,
hulls]
Artichokes
0.
05
0.
05
[Artichoke,
globe]
Avocados
0.05
0.05
[Avocado]
Bananas
(including
plantain)
0.05
TBD
1
[Banana
(including
plantain)]
Broccoli
0.05
0.05
The
registrant
may
wish
to
propose
a
crop
group
tolerance
of
0.05
ppm
for
Head
and
stem
Brassica
subgroup.
Cabbage
0.05
0.05
Cauliflower
0.
05
0.
05
Cattle,
fat
0.
05
0.
01
Cattle,
mbyp
0.05
0.01
Cattle,
meat
0.05
0.01
Cocoa
beans
0.
05
TBD
1
[Cacao
bean]
Coffee
0.
05
0.
05
[Coffee
bean,
green]
Corn,
grain
0.
05
0.
05
[Corn,
field,
grain]
Cottonseed
0.05
0.05
[Cotton,
undelinted
seed]
Dates
0.
05
0.
05
[Date]
Eggs
0.05
0.03
Feijoa
0.
05
0.
05
[Feijoa
(pineapple
guava)]
Figs
0.05
0.05
[Fig]
Garlic
0.05
Goat,
fat
0.
05
0.
01
Goat,
mbyp
0.05
0.01
Goat,
meat
0.05
0.01
Grapes
0.05
0.05
[Grape]
Hogs,
fat
0.
05
0.
01
Hogs,
mbyp
0.05
0.01
Hogs,
meat
0.05
0.01
Commodity
Current
Tolerance
(ppm)
Tolerance
Reassessment
(ppm)
Comment/
[Correct
Commodity
Definition]
44
Horseradish
0.
05
0.
05
Horses,
fat
0.
05
0.
01
Horses,
mbyp
0.05
0.01
Horses,
meat
0.05
0.01
Kiwifruit
0.05
0.05
Olives
0.05
0.05
[Olive]
Onions
(dry
bulb)
0.05
0.05
[Onion,
dry
bulb
(only)]
Milk
0.05
0.01
Mint
hay
(peppermint
and
spearmint)
0.1
0.
05
Separate
tolerances
should
be
established,
each
at
0.05
ppm
for:
[Peppermint,
tops]
[Spearmint,
tops]
Persimmons
0.05
0.05
[Persimmon]
Pistachios
0.
05
0.
05
[Pistachio]
Pome
fruits
group
0.05
0.05
[Fruit,
Pome,
Group]
Pomegranates
0.05
0.05
[Pomegranate]
Poultry,
fat
0.
05
0.
2
Poultry,
mbyp
0.05
0.01
Poultry,
meat
0.05
0.01
Sheep,
fat
0.
05
0.
01
Sheep,
mbyp
0.05
0.01
Sheep,
meat
0.05
0.01
Soybeans
0.
05
0.
05
[Soybean]
Stone
fruits
group
0.05
0.05
[Fruits,
Stone,
Group]
Tree
nuts
group
(except
almond
hulls)
0.05
0.05
[Nuts,
Tree,
Group]
For
tolerance
reassessment
counting
purposes
walnut
was
counted
separately
because
it
had
been
listed
separately
in
the
Tolerance
Index
System
.
Tolerances
To
Be
Proposed
Under
40
CFR
§180.381
(a):
Cotton,
gin
byproducts
None
TBD
1
New
RAC
according
to
Table
1
(OPPTS
860.1000).
Soybean
forage
None
TBD
1
A
feeding
restriction
may
be
established
in
lieu
of
proposing
tolerances.
Soybean
hay
None
TBD
1
Tolerances
Listed
Under
40
CFR
§180.381
(c):
Blackberry
0.05
0.05
Recently
established
under
PP#
5E04429
(60
FR
62330,
12/
6/
95)
Garbanzo
beans
0.
05
0.
05
[Chickpea
(bean,
garbanzo)]
Guava
0.
05
0.
05
Papaya
0.05
0.05
Raspberry
0.05
0.05
Recently
established
under
PP#
5E04429
(60
FR
62330,
12/
6/
95)
Commodity
Current
Tolerance
(ppm)
Tolerance
Reassessment
(ppm)
Comment/
[Correct
Commodity
Definition]
45
Taro
(corms
and
leaves)
0.05
0.05
Separate
tolerances
should
be
established,
each
at
0.05
ppm
for:
[Taro,
corm],
[Taro,
foliage]
Tolerances
To
Be
Proposed
Under
40
CFR
§180.381
(c)
Grass
Forage,
Grass
Hay,
and
Grass
Seed
Screenings
None
0.05
Separate
tolerances
should
be
established,
each
at
0.05
ppm
for
grass
forage,
grass
hay
and
grass
seed
screenings
TBD
=
To
be
determined.
This
term
means
the
tolerance
to
be
set
will
be
safe.
However,
additional
confirmatory
data
are
needed
to
be
able
to
set
the
tolerance
level.
Residue
Analytical
Methods
The
Pesticide
Analytical
Manual
(PAM)
Vol.
II
lists
two
GLC/
electron
capture
detector
(ECD)
methods,
designated
as
Methods
I
and
II,
for
the
enforcement
of
tolerances
for
oxyfluorfen
residues
in/
on
plant
and
animal
commodities,
respectively.
Both
methods
determine
levels
of
oxyfluorfen
and
its
reduced
metabolites
by
a
common
moiety
(as
heptafluorobutyryl
derivatives
of
oxyfluorfen).
The
tolerance
expression
for
oxyfluorfen
was
amended
(60
FR
62330,
12/
6/
95)
to
delete
the
metabolites
of
oxyfluorfen
containing
the
diphenyl
ether
linkage.
The
established
tolerances
for
plant
and
animal
commodities
[40
CFR
§180.381
(a),
(b),
and
(c)]
are
now
expressed
in
terms
of
oxyfluorfen
per
se
[2
chloro
1(
3
ethoxy
4
nitrophenoxy)
4
(trifluoromethyl)
benzene].
Because
oxyfluorfen
per
se
is
now
the
residue
of
concern,
the
PAM
Vol.
II
methods
are
no
longer
suitable
for
enforcement
purposes.
EPA
recommends
that
FDA's
Multiresidue
Methods
for
oxyfluorfen
per
se
be
utilized
as
the
primary
enforcement
method
for
plant
commodities
until
the
registrant
submits
a
proposed
enforcement
method
for
plants
to
determine
oxyfluorfen
per
se.
An
enforcement
method
for
the
determination
of
oxyfluorfen
per
se
in
animal
commodities
is
required
as
FDA's
Multiresidue
Methods
are
not
suitable
for
animal
commodities.
New
single
analyte
methods
are
being
proposed
for
determination
of
residues
of
oxyfluorfen
per
se
for
enforcement
and
data
collection
purposes.
In
conjunction
with
a
pending
tolerance
petition
(PP#
3F4229/
FAP#
3H5674)
on
peanut,
the
registrant
proposed
a
GC/
ECD
method
(Method
TR
34
94
150,
renamed
as
Method
TR
34
95
111)
including
a
confirmatory
GC/
MS
method
for
the
enforcement
of
oxyfluorfen
tolerances
on
plant
commodities.
The
stated
limits
of
quantitation
(LOQ)
and
detection
(LOD)
for
Method
TR
34
95
111
are
0.01
ppm
and
0.003
ppm,
respectively,
except
on
peanut
vine,
shell,
and
hay
for
which
the
reported
LOQ
and
LOD
are
0.02
ppm
and
0.007
ppm,
respectively.
Method
TR
34
95
111
was
adequately
validated
by
the
registrant
using
a
wide
array
of
plant
matrices
and
by
an
independent
laboratory
using
peanut
nutmeat.
The
method
will
be
forwarded
to
the
Biological
and
Economic
Analysis
Division's
Analytical
Chemical
Laboratory
for
a
petition
method
validation
trial
to
ensure
that
the
procedures
are
appropriate
for
tolerance
enforcement.
46
Also
in
conjunction
with
PP#
3F4229/
FAP#
3H5674,
the
registrant
proposed
a
GC/
ECD
method
(Method
TR
34
95
110)
including
a
confirmatory
GC/
MS
method
for
the
enforcement
of
oxyfluorfen
tolerances
on
animal
commodities.
The
stated
LOQ
and
LOD
for
Method
TR
34
95
110
are
0.01
ppm
and
0.003
ppm,
respectively,
for
all
animal
commodities.
Method
TR
34
95
110
was
adequately
validated
by
the
registrant
using
a
variety
of
animal
matrices
and
by
an
independent
laboratory
using
milk
and
chicken
fat.
The
method
was
also
successfully
radiovalidated
using
aged
samples
from
the
hen
and
goat
metabolism
studies.
EPA
will
forward
Method
TR
34
95
110
to
the
Biological
and
Economic
Analysis
Division's
Analytical
Chemical
Laboratory
(ACL)
for
a
petition
method
validation
trial.
D.
Regulatory
Rationale
The
following
is
a
summary
of
the
rationale
for
managing
risks
associated
with
the
current
use
of
oxyfluorfen.
Where
labeling
revisions
are
warranted,
specific
language
is
set
forth
in
the
summary
tables
of
Section
V
of
this
document.
1.
Human
Health
Risk
Management
a.
Dietary
(Food)
Risk
Mitigation
No
adverse
effects
reflecting
a
single
dose
were
identified;
therefore,
no
acute
endpoint
was
selected
and
an
acute
dietary
risk
assessment
was
not
conducted.
A
refined
Tier
3
dietary
risk
assessment
using
the
Dietary
Exposure
Evaluation
Model
(DEEM
TM
)
was
completed
for
chronic
food
exposure.
The
DEEM
TM
analysis
evaluated
the
individual
food
consumption
as
reported
by
respondents
in
the
USDA
1989
91
Continuing
Surveys
for
Food
Intake
by
Individuals
(CSFII)
and
accumulated
exposure
to
the
chemical
for
each
commodity.
For
all
analyses,
anticipated
residues
and
percent
of
crop
treated
data
were
used.
(1)
Chronic
Dietary
(Food)
The
chronic
dietary
analysis
utilized
USDA
Pesticide
Data
Program
(PDP)
monitoring
data,
field
trial
data,
and
percent
crop
treated
information.
Based
on
that
analysis,
the
percentage
of
cPAD
utilized
is
expected
to
be
less
than
1
percent
for
the
U.
S.
population
and
all
subpopulations.
Therefore,
the
chronic
dietary
(food)
risk
estimate
is
not
of
concern,
and
no
mitigation
measures
are
needed.
(2)
Cancer
Dietary
(Food)
A
cancer
dietary
exposure
and
risk
analysis
was
performed
based
upon
revised
cancer
Q1*
of
7.32
x
10
2
derived
from
a
mouse
carcinogenicity
study
and
upon
Agency
analyses
of
anticipated
residues
in
food.
Based
on
that
analysis,
which
yielded
a
cancer
risk
of
3.8
x
10
7
,
the
Agency
has
concluded
that
the
cancer
dietary
risk
from
food
alone
is
not
of
concern
(<
1
x
10
6
),
and
that
no
mitigation
measures
are
needed
to
address
the
cancer
food
risk.
47
(3)
Drinking
Water
As
previously
mentioned,
acute
endpoints
were
not
established
for
oxyfluorfen
and
an
acute
drinking
water
assessment
was
not
performed.
The
Agency
has
determined
that
there
are
no
chronic
(non
cancer)
drinking
water
concerns,
as
the
chronic
EECs
are
substantially
less
than
the
DWLOCs
for
all
populations
(see
Section
III.
A.
2).
However,
the
Agency
risk
assessment
shows
potential
dietary
cancer
risks
of
concern
for
drinking
water
derived
from
surface
waters.
This
assessment
was
based
on
modeling
simulations
which
predict
that
oxyfluorfen
residues
in
surface
waters
have
a
36
year
annual
mean
concentration
of
5.7
ppb.
In
comparison,
the
cancer
DWLOC
based
on
food
exposure
is
0.315
ppb.
EPA
believes
that
the
DWLOC
based
on
food
exposure
is
upper
bound
because
PDP
and
field
trial
residue
data
show
all
non
detectable
residues,
and
½
the
LOQ
was
used
in
the
dietary
(food)
assessment
which
overestimates
residue
values.
EPA
used
½
LOQ
rather
than
½
LOD
for
field
trial
residue
values
because
of
the
possibility
of
an
occasional
residue
of
oxyfluorfen
greater
than
0.01
ppm,
and
the
registrant's
intention
to
propose
a
new
single
analyte
enforcement
method
for
oxyfluorfen
with
a
quantitation
limit
of
0.02
ppm.
Actual
residues
are
expected
to
be
somewhere
in
between
the
calculated
estimates
and
zero.
The
Agency
also
believes
that
the
modeling
simulations
over
estimate
exposures
through
drinking
water.
First,
the
model
input
variables
assumed
maximum
use
rates
and
frequencies.
Usage
data
indicate
that
typical
use
rates
are
below
maximum
use
rates
by
approximately
50%.
Secondly,
the
modeling
assumed
that
the
2
lb
ai/
acre
application
rate
was
being
applied
as
a
broadcast
treatment;
however,
oxyfluorfen
is
typically
applied
as
a
banded
application
between
rows
of
crops.
Careful
targeting
of
the
spray
is
required
because
oxyfluorfen
is
non
selective
and
will
damage
crops.
The
maximum
use
rate
for
crops
per
acre
of
total
land
area
treated
is
generally
around
1.0
lb
ai/
acre.
There
are
oxyfluorfen
use
sites
that
are
broadcast
treated
rather
than
banded,
such
as
bulb
vegetables
or
fallow
land,
but
these
sites
have
a
lower
maximum
rate,
typically
0.5
lbs
ai/
acre/
season.
Nut
trees
may
also
require
broadcast
treatment
to
clear
the
orchard
floor
before
harvest,
but
typically
at
a
rate
of
0.5
lbs
ai/
acre.
Monitoring
data
also
indicate
that
concentrations
may
be
lower
than
what
was
estimated
with
the
PRZM/
EXAMS
model.
For
example,
USGS
conducted
monitoring
of
oxyfluorfen
bound
to
suspended
sediment
for
several
years
in
central
California,
within
an
area
of
high
usage.
The
highest
average
concentration
of
oxyfluorfen
associated
with
the
suspended
sediment
was
27.2
ppb.
From
this
monitoring,
it
is
estimated
that
approximately
0.27
ppb
of
oxyfluorfen
may
be
available
in
the
water,
assuming
reversible
partitioning
with
an
average
Kd
partitioning
coefficient
of
100.
These
water
monitoring
results
are
useful,
but
do
not
negate
the
need
for
targeted
water
monitoring.
The
monitoring
data
available
are
not
adequate
because
the
data
are
mainly
limited
to
sediment
levels,
they
are
limited
to
only
a
few
locations,
and
the
data
are
temporally
limited;
samples
were
often
taken
outside
the
major
use
season.
Also,
the
samples
collected
as
a
result
of
the
August
24,
2000
spill
in
Oregon
indicated
that
a
sediment
detection
of
541
ppb
was
found
in
2
Use
rates
are
higher
(up
to
6
lbs
ai/
broadcast
acre/
season)
for
some
Hawaiian
commodities
such
as
guava,
coffee,
and
macadamia
nuts
because
high
humidity,
heat,
and
rain
require
a
higher
single
application
rate
and
more
frequent
applications.
EPA
is
not
concerned
with
surface
water
contamination
for
drinking
water
risk
purposes
because
drinking
water
sources
are
predominately
groundwater
in
Hawaii.
The
higher
rates
are
addressed
in
more
detail
in
the
ecological
risk
mitigation
section.
48
a
nearby
creek
believed
to
be
unaffected
by
the
spill
and
downstream
from
orchards.
EPA
needs
additional
information
to
ascertain
whether
this
detection
was
actually
related
to
the
spill
or
due
to
the
presence
of
the
upstream
orchards.
In
response
to
potential
dietary
cancer
risks
from
drinking
water
derived
from
surface
waters,
the
registrants
have
agreed
to
several
measures
which
are
expected
to
decrease
the
amount
of
oxyfluorfen
reaching
surface
water:
°
The
maximum
seasonal
application
rate
for
oxyfluorfen
use
on
food
crops
is
currently
2
lbs
ai/
broadcast
acre/
season
2
.
Registrants
have
agreed
to
lower
this
maximum
rate
to
1.5
lbs
ai/
broadcast
acre/
season
and
2
lbs
ai/
acre/
season
for
conifer
seedlings.
The
time
interval
of
the
total
chemical
applied
is
inconsistent
and
unclear
on
some
labels,
and
for
some
uses
the
maximum
poundage
to
be
applied
per
year
or
the
maximum
number
of
applications
per
year
is
not
specified
(e.
g.
right
of
way).
The
maximum
poundage
of
the
chemical
applied
per
acre
must
be
given
on
a
calendar
year
basis
for
all
uses,
or
the
terms
"season"
and
"growing
season"
must
be
clearly
defined
on
the
labels.
°
The
maximum
seasonal
application
rate
for
oxyfluorfen
use
on
ornamentals
is
currently
8
lbs
ai/
A.
For
liquid
formulations
and
granulars
applied
to
field
grown
ornamentals,
registrants
have
agreed
to
lower
this
seasonal
maximum
rate
to
4.5
lbs
ai/
A
(1.5
lbs
ai/
A/
application).
For
granulars
applied
to
containerized
ornamentals,
the
rate
will
be
lowered
to
a
seasonal
maximum
of
6
lbs
ai/
A
(2
lbs
ai/
A/
application).
°
Labeling
will
clearly
limit
the
seasonal
maximum
rate
for
conifer
seedlings
to
2
lbs
ai/
acre.
Information
provide
by
conifer
seedling
growers
indicate
the
need
for
greater
than
1.5
lbs
ai/
acre,
particularly
in
the
South.
Since
conifer
seedling
nurseries
tend
to
be
relatively
small
operations
(20
to
40
acres)
and
only
about
2,500
acres
are
in
U.
S.
production,
EPA
concludes
that
the
2
lb
ai/
acre/
season
rate
is
appropriate
and
will
add
negligible
risk.
°
Label
language
will
be
added
to
require
25
foot,
no
spray,
vegetative
buffer
zones
around
surface
water
bodies
such
as
rivers,
lakes,
streams,
and
ponds.
°
Spray
requirements
will
be
added
to
labels
to
minimize
oxyfluorfen
drift.
Only
use
of
a
coarse,
very
coarse,
or
extremely
coarse
spray
will
be
allowed
according
to
the
ASAE
572
definitions
for
standard
nozzles,
or
a
volume
median
diameter
(VMD)
of
385
microns
or
larger
for
spinning
atomizer
nozzles.
49
The
registrant
(Dow
AgroSciences)
has
further
agreed
to
conduct
a
tiered
surface
water
monitoring
study
to
provide
additional
information
on
potential
drinking
water
contamination.
The
initial
tier
consists
of
an
edge
of
field
water
and
sediment
monitoring
in
a
limited
number
of
vulnerable
sites
around
the
country.
Vulnerability
would
be
based
on
soil
types,
historical
precipitation
levels,
and/
or
other
relevant
factors.
Study
sites
as
well
as
the
monitoring
study
protocol
would
be
agreed
upon
by
the
registrant
and
the
Agency
in
advance
of
study
initiation.
Higher
tiers
(e.
g.,
full
scale
monitoring
study
at
drinking
water
treatment
plants)
would
be
initiated
based
on
the
results
of
the
initial
monitoring.
(4)
Aggregate
Risk
Mitigation
(short
term,
chronic,
and
cancer)
The
short
term
aggregate
risk
assessment
considers
exposures
from
food,
drinking
water,
and
residential
exposures.
As
shown
in
Section
III.
A.
4,
surface
and
ground
water
concentrations
(7.1
ppb
and
0.08
ppb
respectively),
estimated
using
modeling,
are
below
the
short
term
DWLOCs
of
8900
ppb
(females)
and
10400
ppb
(males).
Consequently,
there
are
no
short
term
aggregate
risks
of
concern.
The
chronic
(non
cancer)
aggregate
risk
assessment
addresses
exposure
to
oxyfluorfen
residues
in
food
and
water
only,
as
there
are
no
chronic
residential
scenarios
identified.
The
lowest
DWLOC
of
300
is
substantially
higher
than
the
estimated
environmental
concentrations
of
oxyfluorfen
in
surface
and
groundwater
(7.1
ppb
and
0.08
ppb
respectively).
Consequently,
the
Agency
concludes
that
residues
of
oxyfluorfen
in
food
and
drinking
water
do
not
result
in
a
chronic
aggregate
risk
of
concern.
To
evaluate
cancer
aggregate
risk,
the
chronic
food
cancer
risk
estimate
combined
with
the
highest
residential
cancer
risk
estimate
results
in
a
food
+
residential
cancer
risk
of
1.3
x
10
6
.
Since
the
Agency's
level
of
concern
is
1.0
x
10
6
,
this
cancer
risk
exceeds
EPA's
level
of
concern
when
considering
just
food
and
residential
exposures
combined.
As
stated
previously,
the
exposure
and
risk
estimate
from
food
is
upper
bound
as
all
field
trial
and
PDP
samples
contained
non
detectable
residues
of
oxyfluorfen.
Therefore,
no
mitigation
measures
are
necessary
to
address
dietary
risk
from
food
due
to
aggregate
risk
concerns.
Although
residential
cancer
risk
alone
is
not
of
concern
(<
1.0
x
10
6
),
it
contributes
to
aggregate
risk.
It
is
realistic
to
assume
that
residential
applicators
are
only
applying
1
gallon/
year
with
a
trigger
sprayer;
therefore,
the
highest
residential
cancer
risk
is
6
x
10
7
for
spot
treatment
of
weeds
using
a
low
pressure
tank
sprayer.
Currently,
residential
rates
(4.5
to
8.9
lbs
ai/
acre)
are
considerably
higher
than
agricultural
rates
(2
lbs
ai/
acre).
The
Scotts
Company,
a
registrant
of
two
oxyfluorfen
residential
products,
has
stated
that
a
4.5
lb
ai/
acre
rate
is
necessary
to
control
perennial
grassy
weeds
and
for
effective
residual
control.
The
registrant
is
conducting
efficacy
trials
to
support
appropriate
residential
use
rates.
In
response
to
the
residential/
aggregate
cancer
risks,
the
registrants
have
agreed
to
several
measures
which
are
expected
to
decrease
the
amount
of
oxyfluorfen
used
in
residential
settings:
50
°
The
maximum
application
rate
on
residential
products
will
be
reduced
to
3
lbs
ai/
A
or
less
unless
efficacy
data
support
the
need
for
higher
rates.
This
measure
will
bring
the
residential
rates
in
line
with
the
highest
rate
(2
lb
ai/
A/
season)
needed
for
efficacy
in
agricultural
use
scenarios.
EPA
will
consider
the
results
of
the
efficacy
studies
to
determine
whether
the
data
support
a
different
rate.
Notwithstanding
the
food
+
residential
risk
estimate,
aggregate
cancer
risk
is
still
of
concern
because
surface
water
modeling
indicates
that
there
may
be
a
risk
exceedence
from
oxyfluorfen
in
drinking
water
alone.
The
Agency
believes
this
risk
can
be
reduced
by
implementing
the
risk
mitigation
actions
previously
mentioned
under
drinking
water
risk
management.
The
modeled
drinking
water
concentrations
are
believed
to
be
high
end
estimates
that
may
not
represent
levels
that
people
actually
consume
in
finished
drinking
water
(for
reasons
discussed
earlier
in
the
drinking
water
sections
of
this
document).
However,
the
extent
to
which
the
modeling
may
overestimate
surface
water
concentrations
is
not
known
and
additional
information
is
necessary.
The
registrants
of
oxyfluorfen
must
submit
edge
of
field
water
and
sediment
monitoring.
Pending
review
of
these
studies,
no
additional
mitigation
measures
are
necessary
to
address
drinking
water
concerns
at
this
time.
b.
Occupational
Risk
Mitigation
(1)
Handler
Risks
Handler
exposure
assessments
are
completed
by
EPA
using
a
baseline
exposure
scenario
and,
if
required,
increasing
levels
of
mitigation
(PPE
and
engineering
controls)
to
achieve
an
adequate
margin
of
exposure
(MOE).
For
oxyfluorfen
the
target
MOE
is
100
or
greater
for
short
term
risks
and
300
or
greater
for
intermediate
term
risks.
Analyses
for
handler/
applicator
exposures
were
performed
using
PHED.
These
calculations
indicate
that
the
MOEs
for
most
mixing/
loading
scenarios
and
the
Right
of
Way
application
scenario
are
below
100
at
the
baseline
level
and
exceed
EPA's
level
of
concern.
At
the
single
layer
PPE
level
(which
includes
chemical
resistant
gloves),
all
of
the
scenarios
have
MOEs
of
490
or
greater.
Cancer
risks
to
handlers
are
of
greater
concern
than
non
cancer
risks;
therefore,
risk
mitigation
measures
will
be
determined
based
on
the
cancer
risk
assessment
for
occupational
handlers.
Occupational
cancer
risks
greater
than
1
x
10
4
are
of
concern.
For
risks
between
10
6
and
10
4
,
EPA
carefully
evaluates
exposure
scenarios
to
seek
cost
effective
ways
to
reduce
cancer
risks
to
the
greatest
extent
feasible,
preferably
to
a
risk
of
1
x
10
6
or
less.
At
baseline
and
single
layer
PPE,
cancer
risks
for
all
handler
scenarios
are
greater
than
1
x
10
6
,
but
less
than
1
x
10
4
.
Assuming
the
use
of
double
layer
protective
clothing
currently
on
some
oxyfluorfen
labels,
most
cancer
risks
are
in
the
10
5
range.
To
address
cancer
risks
to
agricultural
handlers,
EPA
has
determined
that
the
following
mitigation
measures
are
necessary,
reasonable,
and
cost
effective:
51
°
closed
mixing/
loading
systems
to
support
applications
to
corn,
cotton,
soybeans,
and
aerial
applications
to
fallow
land;
°
enclosed
cab
for
applications
to
corn,
and
closed
cockpit
aircraft
for
applications
to
fallow
land;
and
°
double
layer
PPE
for
all
other
mixers,
loaders,
and
applicators.
For
high
acreage
crops
such
as
corn,
cotton,
and
soybeans,
engineering
controls
for
mixing
and
loading,
and
closed
cabs
are
increasingly
common
for
exposure
reduction
as
well
as
for
comfort
and
increased
efficiency
of
mixing
and
transferring
high
volumes
of
chemicals
necessary
to
treat
large
fields.
Also,
EPA
understands
that
virtually
all
agricultural
aviators
currently
use
closed
cockpit
aircraft.
As
such,
EPA
believes
that
these
requirements
are
cost
effective
and
appropriate.
Likewise,
EPA
has
determined
that
the
use
of
engineering
controls
for
additional
handler
scenarios
would
further
reduce
exposure
to
handlers,
but
for
some
scenarios,
such
as
mixing/
loading
and
applying
with
handheld
(backpack)
equipment
and
applying
with
Right
ofWay
spray
equipment,
engineering
controls
are
not
currently
available.
For
other
scenarios,
such
as
mixing/
loading
to
support
applications
to
perennials
including
tree
fruit,
nut,
and
vine
crops,
while
some
engineering
controls
may
be
available
they
are
not
common
with
the
equipment
typically
used
to
make
ground
directed
herbicide
applications
in
these
crops.
Such
equipment
tends
to
be
smaller
and
less
sophisticated
than
the
equipment
used
for
foliar
sprays
of
fungicides
and
insecticides.
EPA
encourages
the
use
of
engineering
controls
in
all
settings
where
practical
and
feasible,
and
allows
for
handlers
to
reduce
PPE
when
engineering
controls
are
used.
But
EPA
concludes
that
the
risk
reduction
potential
of
requiring
engineering
controls
for
additional
scenarios
would
not
be
commensurate
with
the
costs
and
difficulties
associated
with
implementing
the
requirement.
(2)
Post
application
Exposure
Oxyfluorfen
is
a
non
selective
herbicide
that
can
cause
leaf
damage
to
most
of
the
labeled
crops.
For
this
reason,
the
liquid
product
labels
specify
that
it
should
be
applied
to
the
ground
in
such
a
manner
as
to
minimize
crop
damage
and
the
granular
product
labels
specify
that
it
should
be
watered
in
to
rinse
the
granules
off
of
the
foliage.
With
the
exceptions
of
bulb
vegetables
and
conifers,
which
have
more
tolerance
to
oxyfluorfen,
over
the
top
applications
are
not
recommended.
Based
upon
these
factors
it
was
determined
that
re
entry
workers
would
only
have
significant
post
application
exposure
following
applications
of
oxyfluorfen
to
conifer
seedlings,
conifer
trees
and
bulb
vegetables.
The
Restricted
Entry
Interval
(REI)
represents
the
amount
of
time
required
for
residues
to
dissipate
in
treated
areas
prior
to
beginning
a
job
or
task
in
that
area
such
that
the
resulting
exposures
do
not
exceed
the
Agency's
level
of
risk
concern.
In
order
to
determine
the
REI
for
a
crop,
EPA
calculates
the
number
of
days
that
must
elapse
after
pesticide
application
until
residues
dissipate
and
risk
to
a
worker
falls
below
the
target
risk
estimate.
For
a
specific
crop/
pesticide
combination,
the
duration
required
to
achieve
the
target
risk
estimate
can
vary
depending
on
the
activity
assessed.
52
To
address
potential
risks
to
post
application
workers,
the
Agency
is
modifying
the
REIs
for
oxyfluorfen
as
described
in
Table
24
below.
Since
the
conifer
REIs
are
based
on
the
chemical
specific
DFR
study
which
has
serious
deficiencies,
a
confirmatory
DFR
study
on
conifers
is
necessary.
For
all
post
application
commercial
worker
exposure
scenarios,
the
proposed
REIs
provide
estimated
dermal
MOEs
greater
than
the
target
MOE
of
300.
Although
the
estimated
cancer
risks
for
some
of
the
scenarios
are
slightly
above
the
1
x
10
6
target
value,
they
are
still
in
the
10
6
range,
and
the
Agency
believes
these
REIs
provide
an
acceptable
level
of
protection
without
disruption
to
needed
cultural
practices.
Table
24.
Restricted
Entry
Intervals
(REIs)
for
Oxyfluorfen
Crop
Pre
harvest
Interval
(days)
REI
(days)
Comments
Bulb
vegetables
45
(dry
bulb
onion)
60
(onions
grown
for
seed)
60
(dry
bulb
garlic)
6
months
(taro)
2
A
two
day
REI
results
in
a
cancer
risk
estimate
of
2.7
x
10
6
.
Conifer
seedlings
N/
A
3
A
three
day
REI
results
in
a
cancer
risk
estimate
of
3.1
x
10
6
.
Conifer
trees
N/
A
6
An
REI
of
6
days
results
in
a
cancer
risk
estimate
of
1.8
x
10
6
for
low
exposure
activities
(e.
g.
irrigation,
scouting,
hand
weeding)
and
5.4
x
10
6
for
medium
exposure
activities
(shearing).
Since
oxyfluorfen
is
applied
to
weeds
in
Christmas
tree
plantations
in
a
semi
directed
manner
to
reduce
tree
contact,
only
the
lower
branches
typically
receive
overspray.
Therefore,
the
risk
estimates
for
Christmas
tree
shearing
are
probably
conservative.
All
other
crops
N/
A
24
hours
Current
Labeling
Scouting
is
a
handler
activity
under
the
WPS,
so
anyone
performing
this
activity
may
legally
enter
the
treated
field
during
the
REI
provided
they
use
the
handler
personal
protective
equipment
(PPE)
specified
on
the
label.
In
addition,
if
the
scout
is
a
certified
crop
advisor
as
defined
in
the
WPS
[40
CFR
170.204(
b)],
the
individual
can
determine
the
appropriate
PPE
to
be
used.
For
many
of
these
crops,
irrigation
equipment
is
not
routinely
moved
by
hand.
For
these
methods,
the
primary
activity
involves
entering
the
field
to
turn
the
watering
equipment
on
and
off.
This
activity
is
allowed
during
the
REI
under
the
no
contact
exception
to
WPS
[40
CFR
170.112(
b)].
Should
irrigation
equipment
need
unexpected
repairs
during
the
REI,
WPS
allows
workers
to
enter
a
treated
field
provided
early
entry
PPE
is
used
[40
CFR
170.112(
c)].
This
exception
also
usually
applies
to
mechanical
harvesting
and
tree
shaking
for
nut
crops
in
enclosed
cabs.
53
2.
Environmental
Risk
Mitigation
a.
Risk
Characterization
(1)
Aquatic
Organisms
Oxyfluorfen
has
the
potential
to
affect
aquatic
ecological
systems
at
all
levels,
as
it
is
toxic
to
plants,
invertebrates,
and
fish,
and
exceeds
the
LOCs
based
on
modeled
EECs.
For
freshwater
invertebrates,
the
chronic
level
of
concern
was
exceeded
in
all
Florida
citrus
scenarios,
as
well
as
for
the
maximum
application
rate
on
New
York
grapes.
For
estuarine
invertebrates,
the
acute
risk
level
of
concern
is
exceeded
for
all
citrus
scenarios.
Based
on
toxicity
data
to
invertebrates,
oxyfluorfen
may
pose
long
term
effects
to
benthic
(soil
dwelling)
aquatic
organisms;
however,
data
on
persistence
and
toxicity
in
the
benthic
environment
is
poor.
Dissolved
oxyfluorfen
concentrations
are
expected
to
be
relatively
low
in
runoff
water.
However,
because
of
oxyfluorfen's
high
affinity
to
soil,
soil
eroding
from
application
areas
is
likely
to
carry
bound
oxyfluorfen
to
aquatic
areas.
The
RQs
for
all
modeled
scenarios
exceed
the
acute
risk
level
of
concern
for
freshwater
algal
plants.
The
risk
to
vascular
aquatic
plants
cannot
be
assessed
due
to
lack
of
data.
(2)
Terrestrial
Organisms
For
acute
exposures,
oxyfluorfen
is
practically
non
toxic
to
birds,
mammals,
and
bees,
and
the
Agency
has
no
risk
concerns.
However,
subchronic
and
chronic
risks
to
terrestrial
birds
and
mammals
do
present
a
concern.
These
toxic
effects
may
be
manifested
as
reproductive,
developmental,
and
hemolytic
consequences.
Assuming
maximum
residue
values,
the
chronic
level
of
concern
is
exceeded
when
oxyfluorfen
is
applied
to
crops
at
application
rates
greater
than
or
equal
to
0.25
lbs
ai/
acre/
year
for
birds
and
greater
than
or
equal
to
2.0
lbs
ai/
acre
for
mammals.
Oxyfluorfen
is
expected
and
has
been
shown
to
negatively
impact
seedling
emergence
and
vegetative
vigor
of
terrestrial
plants.
Non
target
terrestrial
plants
are
exposed
to
oxyfluorfen
as
a
result
of
spray
drift
and
runoff
and
most
incidents
reported
to
the
Agency
are
related
to
plants
affected
by
spray
drift.
Acute
levels
of
concern
are
exceeded
for
all
uses
of
oxyfluorfen
for
terrestrial
plants
and
semi
aquatic
plants
adjacent
to
treated
areas.
(3)
Endangered
Species
The
preliminary
risk
assessment
for
endangered
species
indicates
that
oxyfluorfen
exceeds
the
endangered
species
LOCs
for
the
following
combinations
of
analyzed
uses
and
species:
°
terrestrial
plants
for
all
uses;
54
°
avian
chronic
for
non
bearing
citrus
and
all
applications
with
rates
greater
than
0.5
lb
ai/
acre/
application
(such
as
rights
of
way,
apples,
walnuts
and
grapes)
based
on
both
maximum
and
mean
residue
levels;
°
mammalian
chronic
for
non
bearing
citrus,
and
applications
with
rates
of
2
lbs
ai/
acre
such
as
rights
of
way,
apples,
walnuts
and
grapes)
based
on
maximum
residues;
°
freshwater
fish
for
non
bearing
citrus
and
grapes
(of
those
scenarios
modeled);
and
°
freshwater
invertebrates
for
non
bearing
citrus,
apples,
grapes
and
cotton
(of
thosescenarios
modeled).
Based
on
the
available
data,
oxyfluorfen
acute
toxicity,
RQs,
and
LOC
exceedences
for
estuarine/
marine
fish
were
assumed
to
be
similar
to
that
of
freshwater
fish.
Although
the
endangered
species
LOC
for
estuarine
invertebrates
has
been
exceeded,
there
are
no
federally
listed
species
in
this
group.
Risks
to
endangered
aquatic
vascular
plants
cannot
be
assessed
at
this
time
since
no
acceptable
toxicity
test
for
Lemna
gibba
has
been
submitted
to
the
Agency.
(4)
Mitigation
Measures
Those
same
mitigation
measures
that
will
reduce
drinking
water
exposure
will
also
reduce
exposure
to
non
target
organisms.
A
reduction
in
maximum
seasonal
rates
from
2.0
lbs
ai/
broadcast
acre
to
1.5
lbs
ai/
broadcast
acre
will
protect
both
aquatic
and
terrestrial
organisms.
The
maintained
25
foot
vegetative
buffer
strip
is
designed
to
reduce
the
potential
for
oxyfluorfen
to
contaminate
water
through
runoff.
The
buffer
strips
in
combination
with
use
of
only
coarse,
very
coarse,
or
extremely
coarse
spray
will
also
reduce
exposure
to
aquatic
organisms
through
spray
drift.
The
water
and
sediment
monitoring
will
further
refine
the
exposure
potential
for
aquatic
and
sediment
dwelling
species.
3.
Other
Label
Statements
In
order
to
be
eligible
for
reregistration,
various
use
and
safety
information
must
also
be
placed
on
the
labeling
of
all
end
use
products
containing
oxyfluorfen.
For
the
specific
labeling
statements,
refer
to
Section
V
of
this
document.
a.
Endangered
Species
Statement
The
Agency
has
developed
the
Endangered
Species
Protection
Program
to
identify
pesticides
whose
use
may
cause
adverse
impacts
on
endangered
and
threatened
species,
and
to
implement
mitigation
measures
that
address
these
impacts.
The
Endangered
Species
Act
requires
federal
agencies
to
ensure
that
their
actions
are
not
likely
to
jeopardize
listed
species
or
adversely
modify
designated
critical
habitat.
To
analyze
the
potential
of
registered
pesticide
uses
to
affect
any
particular
species,
EPA
puts
basic
toxicity
and
exposure
data
developed
for
REDs
into
context
for
individual
listed
species
and
their
locations
by
evaluating
important
ecological
parameters,
pesticide
use
information,
the
geographic
relationship
between
specific
pesticides
uses
and
species
locations,
and
biological
requirements
and
behavioral
aspects
of
the
particular
species.
This
analysis
will
take
into
consideration
any
regulatory
changes
55
recommended
in
this
RED
that
are
being
implemented
at
that
time.
A
determination
that
there
is
a
likelihood
of
potential
impact
to
a
listed
species
may
result
in
limitations
on
use
of
the
pesticide,
other
measures
to
mitigate
any
potential
impact,
or
consultations
with
the
Fish
and
Wildlife
Service
and/
or
the
National
Marine
Fisheries
Service
as
necessary.
The
Endangered
Species
Protection
Program
as
described
in
a
Federal
Register
notice
(54
FR
27984
28008,
July
3,
1989)
is
currently
being
implemented
on
an
interim
basis.
As
part
of
the
interim
program,
the
Agency
has
developed
County
Specific
Pamphlets
that
articulate
many
of
the
specific
measures
outlined
in
the
Biological
Opinions
issued
to
date.
These
Pamphlets
are
available
for
voluntary
use
by
pesticide
applicators,
on
EPA's
web
site
at
www.
EPA.
gov/
espp
.
A
final
Endangered
Species
Protection
Program,
which
may
be
altered
from
the
interim
program,
is
scheduled
to
be
proposed
for
public
comment
in
the
Federal
Register
in
2002.
b.
Spray
Drift
Management
The
Agency
is
in
the
process
of
developing
more
appropriate
label
statements
for
spray,
and
dust
drift
control
to
ensure
that
public
health,
and
the
environment
is
protected
from
unreasonable
adverse
effects.
In
August
2001,
EPA
published
draft
guidance
for
label
statements
in
a
pesticide
registration
(PR)
notice
("
Draft
PR
Notice
2001
X"
http://
www.
epa.
gov/
PR_
Notices/#
2001).
A
Federal
Register
notice
was
published
on
August
22,
2001,
66
FR
44141
(http://
www.
epa.
gov/
fedrgstr)
announcing
the
availability
of
this
draft
guidance
for
a
90
day
public
comment
period.
After
receipt,
and
review
of
the
comments,
the
Agency
will
publish
final
guidance
in
a
PR
notice
for
registrants
to
use
when
labeling
their
products.
Until
EPA
decides
upon,
and
publishes
the
final
label
guidance
for
spray,
and
dust
drift,
the
registrant
for
oxyfluorfen
has
agreed
to
add
the
following
spray
drift
related
language,
in
part
to
address
concerns
of
surface
water
runoff
of
oxyfluorfen.
A
25
ft.
vegetative
buffer
strip
must
be
maintained
between
all
areas
treated
with
this
product
and
lakes,
reservoirs,
rivers,
permanent
streams,
marshes
or
natural
ponds,
estuaries
and
commercial
fish
farm
ponds.
"Do
not
allow
spray
to
drift
from
the
application
site
and
contact
people,
structures
people
occupy
at
any
time
and
the
associated
property,
parks
and
recreation
areas,
nontarget
crops,
aquatic
and
wetland
areas,
woodlands,
pastures,
rangelands,
or
animals.
For
groundboom
applications,
apply
with
nozzle
height
no
more
than
4
feet
above
the
ground
or
crop
canopy
and
when
wind
speed
is
10
mph
or
less
at
the
application
site
as
measured
by
an
anemometer.
Use
coarse
spray
according
to
ASAE
572
definition
for
standard
nozzles
or
VMD
of
475
microns
for
spinning
atomizer
nozzles.
The
applicator
also
must
use
all
other
measures
necessary
to
control
drift."
56
V.
What
Registrants
Need
to
Do
The
Agency
has
determined
that
oxyfluorfen
is
eligible
for
reregistration
provided
that:
(i)
additional
data
that
the
Agency
intends
to
require
confirm
this
interim
decision;
and
(ii)
the
risk
mitigation
measures
outlined
in
this
document
are
adopted,
and
label
amendments
are
made
to
reflect
these
measures.
To
implement
the
risk
mitigation
measures,
the
registrants
must
amend
their
product
labeling
to
incorporate
the
label
statements
set
forth
in
the
Label
Summary
Table
in
Section
V.
D
below.
The
additional
data
requirements
that
the
Agency
intends
to
obtain
will
include,
among
other
things,
submission
of
the
following:
A.
For
oxyfluorfen
technical
grade
active
ingredient
products,
registrants
need
to
submit
the
following
items.
Within
90
days
from
receipt
of
the
generic
data
call
in
(DCI):
(1)
completed
response
forms
to
the
generic
DCI
(i.
e.,
DCI
response
form
and
requirements
status
and
registrant's
response
form);
and
(2)
submit
any
time
extension
and/
or
waiver
requests
with
a
full
written
justification.
Within
the
time
limit
specified
in
the
generic
DCI:
(1)
cite
any
existing
generic
data
which
address
data
requirements
or
submit
new
generic
data
responding
to
the
DCI.
Please
contact
John
Leahy
at
(703)
305
6703
with
questions
regarding
generic
reregistration
and/
or
the
DCI.
All
materials
submitted
in
response
to
the
generic
DCI
should
be
addressed:
By
US
mail:
By
express
or
courier
service:
Document
Processing
Desk
(DCI/
SRRD)
Document
Processing
Desk
(DCI/
SRRD)
John
Leahy
John
Leahy
US
EPA
(7508C)
Office
of
Pesticide
Programs
(7508C)
1200
Pennsylvania
Ave.,
NW
Room
266A,
Crystal
Mall
2
Washington,
DC
20460
1921
Jefferson
Davis
Highway
Arlington,
VA
22202
B.
For
products
containing
the
active
ingredient
oxyfluorfen
registrants
need
to
submit
the
following
items
for
each
product.
Within
90
days
from
the
receipt
of
the
product
specific
data
call
in
(PDCI):
57
(1)
completed
response
forms
to
the
PDCI
(i.
e.,
PDCI
response
form
and
requirements
status
and
registrant's
response
form);
and
(2)
submit
any
time
extension
or
waiver
requests
with
a
full
written
justification.
Within
eight
months
from
the
receipt
of
the
PDCI:
(1)
two
copies
of
the
confidential
statement
of
formula
(EPA
Form
8570
4);
(2)
a
completed
original
application
for
reregistration
(EPA
Form
8570
1).
Indicate
on
the
form
that
it
is
an
"application
for
reregistration";
(3)
five
copies
of
the
draft
label
incorporating
all
label
amendments
outlined
in
Table
25
of
this
document;
(4)
a
completed
form
certifying
compliance
with
data
compensation
requirements
(EPA
Form
8570
34);
(5)
if
applicable,
a
completed
form
certifying
compliance
with
cost
share
offer
requirements
(EPA
Form
8570
32);
and
(6)
the
product
specific
data
responding
to
the
PDCI.
Please
contact
Bonnie
Adler
at
(703)
308
8523
with
questions
regarding
product
reregistration
and/
or
the
PDCI.
All
materials
submitted
in
response
to
the
PDCI
should
be
addressed:
By
US
mail:
By
express
or
courier
service
only:
Document
Processing
Desk
(PDCI/
PRB)
Document
Processing
Desk
(PDCI/
PRB)
Bonnie
Adler
Bonnie
Adler
US
EPA
(7508C)
Office
of
Pesticide
Programs
(7508C)
1200
Pennsylvania
Ave.,
NW
Room
266A,
Crystal
Mall
2
Washington,
DC
20460
1921
Jefferson
Davis
Highway
Arlington,
VA
22202
A.
Manufacturing
Use
Products
1.
Additional
Generic
Data
Requirements
The
generic
data
base
supporting
the
reregistration
of
oxyfluorfen
for
the
above
eligible
uses
has
been
reviewed
and
determined
to
be
substantially
complete.
However
the
following
data
requirements
are
necessary
to
confirm
the
reregistration
eligibility
decision
documented
in
this
RED.
58
OPPTS
GLN
870.3200:
21
day
Dermal
Toxicity
Study
in
Rats
OPPTS
GLN
870.3465:
90
day
Subchronic
Inhalation
Toxicity
OPPTS
GLN
860.1200:
(Directions
for
Use
)
Label
revisions
are
required
OPPTS
GLN
860.1500:
Crop
Field
Trials
in
Bananas
and
Cacao
Beans
OPPTS
GLN
850.1400:
Estuarine/
marine
Fish
Early
life
Stage
OPPTS
GLN
850.1735:
Whole
sediment
acute
toxicity
invertebrates,
Fresh
Water
OPPTS
GLN
850.1740:
Whole
sediment
acute
toxicity
invertebrates,
Estuarine/
marine
OPPTS
GLN
850.1300:
Daphnid
Chronic
Toxicity
OPPTS
GLN
850.2300:
Avian
Reproduction
Studies,
Quail
and
Duck
OPPTS
GLN
850.4225:
Seed
Germination/
seedling
Emergence
OPPTS
GLN
850.4250:
Vegetative
Vigor
OPPTS
GLN
850.4400:
Aquatic
Plant
Growth
OPPTS
GLN
875.2100:
Dislodgeable
Foliar
Residue
Study
in
Conifers
Non
Guideline
Studies:
Fish
Phototoxicity
Study.
Oxyfluorfen
has
a
light
dependent
peroxidase
and
may
be
more
toxic
to
fish
in
clear
natural
waters
than
the
guideline
fish
acute
toxicity
study
would
indicate.
This
study
should
quantify
any
additional
toxicity
which
is
light
induced.
Edge
of
Field
Water
and
Sediment
Monitoring.
Simple
initial
tier
study
to
determine
oxyfluorfen
residues
in
drinking
water.
Monitoring
of
drinking
water
is
reserved
pending
the
results
of
this
study.
2.
Labeling
for
Manufacturing
Use
Products
To
ensure
compliance
with
FIFRA,
manufacturing
use
product
(MUP)
labeling
should
be
revised
to
comply
with
all
current
EPA
regulations,
PR
Notices
and
applicable
policies.
The
MP
labeling
should
bear
the
labeling
contained
in
Table
25
at
the
end
of
this
section.
B.
End
Use
Products
1.
Additional
Product
Specific
Data
Requirements
Section
4(
g)(
2)(
B)
of
FIFRA
calls
for
the
Agency
to
obtain
any
needed
product
specific
data
regarding
the
pesticide
after
a
determination
of
eligibility
has
been
made.
Registrants
must
review
previous
data
submissions
to
ensure
that
they
meet
current
EPA
acceptance
criteria
and
if
not,
commit
to
conduct
new
studies.
If
a
registrant
believes
that
previously
submitted
data
meet
current
testing
standards,
then
the
study
MRID
numbers
should
be
cited
according
to
the
instructions
in
the
Requirement
Status
and
Registrants
Response
Form
provided
for
each
product.
59
A
product
specific
data
call
in,
outlining
specific
data
requirements,
accompanies
this
RED.
2.
Labeling
for
End
Use
Products
Labeling
changes
are
necessary
to
implement
the
mitigation
measures
outlined
in
Section
IV
above.
Specific
language
to
incorporate
these
changes
is
specified
in
Table
25.
C.
Existing
Stocks
Registrants
may
generally
distribute
and
sell
products
bearing
old
labels/
labeling
for
12
months
from
the
date
of
the
issuance
of
this
Reregistration
Eligibility
Decision
document.
Persons
other
than
the
registrant
may
generally
distribute
or
sell
such
products
for
24
months
from
the
date
of
the
issuance
of
this
RED.
However,
existing
stocks
time
frames
will
be
established
case
by
case,
depending
on
the
number
of
products
involved,
the
number
of
label
changes,
and
other
factors.
Refer
to
"Existing
Stocks
of
Pesticide
Products;
Statement
of
Policy";
Federal
Register,
Volume
56,
No.
123,
June
26,
1991.
60
D.
Required
Labeling
Changes
Summary
Table
Table
25
Summary
of
Required
Labeling
Changes
for
Oxyfluorfen
Description
Required
Labeling
Placement
on
Label
Manufacturing
Use
Products
One
of
these
statements
may
be
added
to
a
label
to
allow
reformulation
of
the
product
for
a
specific
use
or
all
additional
uses
supported
by
a
formulator
or
user
group
"Only
for
formulation
into
an
herbicide
for
the
following
use(
s):
artichokes
(globe),
broccoli,
cabbage,
cauliflower,
cacao,
citrus
(non
bearing),
coffee,
conifers
(seedbeds,
transplants,
container
stock)
and
selected
deciduous
trees,
corn,
cotton,
cottonwood,
eucalyptus,
fallow
bed
(cotton/
soybeans),
fallow
land,
garbanzo
beans,
garlic,
guava
(Hawaii
only),
horseradish,
jojoba,
mint,
onions,
onions
grown
for
seed,
papayas
(Hawaii
only),
soybeans,
taro,
and
tree
fruit,
nuts,
and
vines
(which
includes
almond,
apple,
avocado,
beechnut,
brazil
nut,
butternut,
cashew,
cherry,
chestnut,
chinquapin,
crabapple,
date,
feijoa,
fig,
filbert,
grapes,
hickory
nut,
kiwi,
loquat,
macadamia
nut,
mayhaw,
nectarines,
olives,
peach,
pear,
pecan,
persimmon,
pistachio,
plum,
pomegranates,
prune,
quince,
walnut).
Directions
for
Use
"This
product
may
be
used
to
formulate
products
for
specific
use(
s)
not
listed
on
the
MP
label
if
the
formulator,
user
group,
or
grower
has
complied
with
U.
S.
EPA
submission
requirements
regarding
support
of
such
use(
s)."
Directions
for
Use
Environmental
Hazards
Statements
Required
by
the
RED
and
Agency
Label
Policies
This
pesticide
is
toxic
to
fish.
Do
not
discharge
effluent
into
lakes,
streams,
ponds,
estuaries,
oceans,
or
public
waters
unless
in
accordance
with
the
requirements
of
a
National
Pollutant
Discharge
Elimination
System
(NPDES)
permit
and
the
permitting
authority
has
been
notified
in
writing
prior
to
discharge.
Do
not
discharge
effluent
containing
this
product
to
sewer
systems
without
previously
notifying
the
sewage
treatment
plant
authority.
For
guidance,
contact
your
State
Water
Board
or
Regional
Office
of
the
EPA.
Directions
for
Use
Handler
PPE
Guidelines
(all
formulations)
Note
the
following
information
when
preparing
labeling
for
all
end
use
products:
For
sole
active
ingredient
end
use
products
that
contain
oxyfluorfen,
the
product
label
must
be
revised
to
adopt
the
handler
personal
protective
equipment
(PPE)/
engineering
control
requirements
set
forth
in
this
section.
Any
conflicting
PPE
requirements
on
the
current
label
must
be
removed.
For
multiple
active
ingredient
end
use
products
that
contain
oxyfluorfen,
the
handler
PPE/
engineering
control
requirements
set
forth
in
this
section
must
be
compared
with
the
requirements
on
the
current
label,
and
the
more
protective
language
must
be
retained.
For
guidance
on
which
requirements
are
considered
to
be
more
protective,
see
PR
Notice
93
7.
PPE
that
will
be
established
on
the
basis
of
Acute
Toxicity
testing
on
end
use
products
undergoing
product
reregistration
must
be
compared
with
the
active
ingredient
PPE
specified
below
by
the
RED.
The
more
protective
PPE
must
be
placed
in
the
product
labeling.
For
guidance
on
which
PPE
is
considered
more
protective,
see
PR
Notice
93
7.
Handler
PPE
Statements
Description
Required
Labeling
Placement
on
Label
61
End
Use
Products
Intended
for
Occupational
Use
(WPS
and
Non
WPS
Uses)
PPE
Requirements
Established
by
the
RED
for
liquid
products
"Personal
Protective
Equipment
(PPE)
Some
materials
that
are
chemical
resistant
to
this
product
are"
(registrant
inserts
correct
chemical
resistant
material).
"If
you
want
more
options,
follow
the
instructions
for
category
[registrant
inserts
A,
B,
C,
D,
E,
F,
G,
or
H]
on
an
EPA
chemical
resistance
category
selection
chart."
Mixers,
loaders
and
applicators
using
engineering
controls
(see
engineering
controls
requirements
below),
must
wear:
Long
sleeved
shirt
and
long
pants
Shoes
plus
socks
Chemical
resistant
gloves
when
mixing
and
loading
Chemical
resistant
apron
when
mixing
and
loading
All
other
mixers,
loaders,
applicators
and
other
handlers
must
wear:
Coveralls
over
long
sleeved
shirt
and
long
pants
Chemical
resistant
footwear
plus
socks
Chemical
resistant
gloves
Chemical
resistant
headgear
when
exposed
overhead
Chemical
resistant
apron
when
exposed
to
the
concentrate
Immediately
following/
below
Precautionary
Statements:
Hazards
to
Humans
and
Domestic
Animals
PPE
Requirements
Established
by
the
RED
for
Granular
product
formulations.
"Personal
Protective
Equipment
(PPE)
Some
materials
that
are
chemical
resistant
to
this
product
are"
(registrant
inserts
correct
chemical
resistant
material).
"If
you
want
more
options,
follow
the
instructions
for
category
[registrant
inserts
A,
B,
C,
D,
E,
F,
G,
or
H]
on
an
EPA
chemical
resistance
category
selection
chart."
Mixers,
loaders,
applicators
and
other
handlers
must
wear:
Coveralls
over
long
sleeved
shirt
and
long
pants
Chemical
resistant
footwear
plus
socks
Chemical
resistant
gloves
Chemical
resistant
apron
for
mixers
and
loaders.
Immediately
following/
below
Precautionary
Statements:
Hazards
to
Humans
and
Domestic
Animals
Description
Required
Labeling
Placement
on
Label
62
User
Safety
Requirements
"Follow
manufacturer's
instructions
for
cleaning/
maintaining
PPE.
If
no
such
instructions
for
washables
exist,
use
detergent
and
hot
water.
Keep
and
wash
PPE
separately
from
other
laundry."
"Discard
clothing
and
other
absorbent
materials
that
have
been
drenched
or
heavily
contaminated
with
this
product's
concentrate.
Do
not
reuse
them."
Precautionary
Statements:
Hazards
to
Humans
and
Domestic
Animals
immediately
following
the
PPE
requirements
Engineering
Controls
Established
by
the
RED
for
liquid
products
"Engineering
Controls
"Mixers
and
loaders
supporting
aerial
applications
to
fallow
land
or
ground
applications
to
corn,
cotton,
or
soybeans
must
use
a
closed
system
that
meets
the
requirements
listed
in
the
Worker
Protection
Standard
(WPS)
for
agricultural
pesticides
[40
CFR
170.240(
d)(
4)],
and
must:
wear
the
personal
protective
equipment
required
above
for
mixers/
loaders
using
engineering
controls,
wear
protective
eyewear
if
the
system
operates
under
pressure,
and
be
provided
and
have
immediately
available
for
use
in
an
emergency,
such
as
a
broken
package,
spill,
or
equipment
breakdown:
coveralls,
and
chemical
resistant
footwear
."
"Handlers
performing
applications
to
corn
must
use
an
enclosed
cab
that
meets
the
definition
in
the
Worker
Protection
Standard
for
Agricultural
Pesticides
[40
CFR
170.240(
d)(
5)]
for
dermal
protection.
In
addition,
such
applicators
must:
wear
the
personal
protective
equipment
required
above
for
applicators
using
engineering
controls,
be
provided
and
must
have
immediately
available
for
use
in
an
emergency
when
they
must
exit
the
cab
in
the
treated
area:
coveralls,
chemical
resistant
gloves,
chemical
resistant
footwear,
and
chemical
resistant
headgear,
if
overhead
exposure,
take
off
any
PPE
that
was
worn
in
the
treated
area
before
reentering
the
cab,
and
store
all
such
PPE
in
a
chemical
resistant
container,
such
as
a
plastic
bag,
to
prevent
contamination
of
the
inside
of
the
cab."
"Pilots
must
use
an
enclosed
cockpit
in
a
manner
that
meets
the
requirements
listed
in
the
Worker
Protection
Standard
(WPS)
for
agricultural
pesticides
[40
CFR
170.240(
d)(
6)];
"When
handlers
use
closed
systems
or
enclosed
cabs
in
a
manner
that
meets
the
requirements
listed
in
the
Worker
Protection
Standard
(WPS)
for
agricultural
pesticides
(40
CFR
170.240(
d)(
4
6),
the
handler
PPE
requirements
may
be
reduced
or
modified
as
specified
in
the
WPS."
Precautionary
Statements:
Hazards
to
Humans
and
Domestic
Animals
(Immediately
following
PPE
and
User
Safety
Requirements.)
Engineering
Controls
Established
by
the
RED
for
Granular
Formulations.
"Engineering
controls"
"When
handlers
use
closed
systems
or
enclosed
cabs
in
a
manner
that
meets
the
requirements
listed
in
the
Worker
Protection
Standard
(WPS)
for
agricultural
pesticides
(40
CFR
170.240(
d)(
4
6),
the
handler
PPE
requirements
may
be
reduced
or
modified
as
specified
in
the
WPS."
Precautionary
Statements:
Hazards
to
Humans
and
Domestic
Animals
(Immediately
following
PPE
and
User
Safety
Requirements.)
Description
Required
Labeling
Placement
on
Label
63
User
Safety
Recommendations
"User
Safety
Recommendations
Users
should
wash
hands
before
eating,
drinking,
chewing
gum,
using
tobacco,
or
using
the
toilet.
Users
should
remove
clothing/
PPE
immediately
if
pesticide
gets
inside.
Then
wash
thoroughly
and
put
on
clean
clothing.
Users
should
remove
PPE
immediately
after
handling
this
product.
Wash
the
outside
of
gloves
before
removing.
As
soon
as
possible,
wash
thoroughly
and
change
into
clean
clothing."
Precautionary
Statements
under:
Hazards
to
Humans
and
Domestic
Animals
immediately
following
Engineering
Controls
(Must
be
placed
in
a
box.)
Environmental
Hazards
"This
product
is
toxic
to
aquatic
invertebrates
and
wildlife.
Do
not
apply
directly
to
water,
or
areas
where
surface
water
is
present
or
to
intertidal
areas
below
the
mean
high
water
mark.
Runoff
from
treated
areas
may
be
hazardous
to
aquatic
organisms
in
neighboring
areas.
See
Directions
for
Use
for
additional
restrictions.
Do
not
contaminate
water
when
disposing
of
equipment
wash
water."
Precautionary
Statements
immediately
following
the
User
Safety
Recommendations
Restricted
Entry
Interval
In
the
Agricultural
Use
Requirements
box,
place
the
following
statements:
"Do
not
enter
or
allow
workers
to
enter
during
the
restricted
entry
interval
(REI).
Directions
for
Use,
Agricultural
Use
Requirements
Box
and
Application
Instructions
for
Appropriate
Crop
In
the
Directions
for
Use
under
Application
Instructions
for
each
crop,
specify
the
following
REIs:
The
REI
is
24
hours
for
all
crops
except
for
the
following:
Onions,
garlic
and
horseradish:
The
REI
is
48
hours.
Conifer
seedlings:
The
REI
is
three
days.
Conifer
trees:
The
REI
is
six
days.
Early
Re
entry
Personal
Protective
Equipment
established
by
the
RED.
"
PPE
required
for
early
entry
to
treated
areas
that
is
permitted
under
the
Worker
Protection
Standard
and
that
involves
contact
with
anything
that
has
been
treated,
such
as
plants,
soil,
or
water,
is:
coveralls,
chemical
resistant
gloves
made
of
any
waterproof
material,
shoes
plus
socks
Directions
for
Use,
Agricultural
Use
Requirements
Box
Description
Required
Labeling
Placement
on
Label
64
REI
Statements
required
if
non
WPS
uses
are
on
the
label
Liquid
Formulations:
"Do
not
enter
or
allow
others
to
enter
until
sprays
have
dried."
Granular
formulations:
"Do
not
enter
or
allow
others
to
enter
until
dusts
have
settled."
Directions
for
Use
Non
Agricultural
Use
Requirements
Box
General
Application
Restrictions
Do
not
apply
this
product
in
a
way
that
will
contact
workers
or
other
persons,
either
directly
or
through
drift.
Only
protected
handlers
may
be
in
the
area
during
application."
Place
in
the
Direction
for
Use
directly
above
the
Agricultural
Use
Box.
Other
Application
Restrictions
The
following
risk
mitigation
measures
must
be
reflected
in
the
directions
for
use:
New
Maximum
Annual
Application
Rates
Restrictions:
All
Food/
Feed
Crops
(except
tropical
commodities
grown
in
HI):
1.5
lbs
ai/
A
All
ornamentals:
liquid
application
rate
of
1.5
lbs/
ai/
application
(4.5
lbs
ai/
season)
Container
grown
ornamentals:
granular
application
rate
of
2
lbs
ai/
A/
application
(6
lbs
ai/
season).
Conifer
seedlings:
2
lbs/
ai/
A.
Directions
for
Use
Description
Required
Labeling
Placement
on
Label
65
Spray
Drift
Buffer
Restrictions
The
following
spray
drift
statement
is
required.
"A
25
ft.
vegetative
buffer
strip
must
be
maintained
between
all
areas
treated
with
this
product
and
lakes,
reservoirs,
rivers,
permanent
streams,
marshes
or
natural
ponds,
estuaries
and
commercial
fish
farm
ponds."
"Do
not
allow
spray
to
drift
from
the
application
site
and
contact
people,
structures
people
occupy
at
any
time
and
the
associated
property,
parks
and
recreation
areas,
non
target
crops,
aquatic
and
wetland
areas,
woodlands,
pastures,
rangelands,
or
animals.
For
groundboom
applications,
apply
with
nozzle
height
no
more
than
4
feet
above
the
ground
or
crop
canopy
and
when
wind
speed
is
10
mph
or
less
at
the
application
site
as
measured
by
an
anemometer.
Use
coarse
spray
according
to
ASAE
572
definition
for
standard
nozzles
or
VMD
of
475
microns
for
spinning
atomizer
nozzles.
The
applicator
also
must
use
all
other
measures
necessary
to
control
drift."
Directions
for
Use
under
General
Application
Instructions
and/
or
Restrictions
End
Use
Products
Intended
for
Residential
Consumer
Use
Environmental
Hazards
"Environmental
Hazards"
"Do
not
apply
directly
to
water.
Do
not
contaminate
water
when
disposing
of
equipment
washwaters
or
rinsate."
Precautionary
Statements
Entry
Restrictions
"Do
not
allow
people
or
pets
to
enter
treated
area
until
spays
have
dried."
Directions
for
Use
General
Application
Restrictions
"Do
not
apply
this
product
in
a
way
that
will
contact
people
or
pets"
Directions
for
Use
Other
Application
Restrictions/
Risk
Mitigation
The
application
instructions
must
be
revised
to
reflect
the
maximum
consumer
product
(residential)
rate
of
3
lbs
ai/
A.
Directions
for
Use
Instructions
in
the
Labeling
Required
section
appearing
in
quotations
represent
the
exact
language
that
must
appear
on
the
label.
Instructions
in
the
Labeling
Required
section
not
in
quotes
represent
actions
that
the
registrant
must
take
to
amend
their
labels
or
product
registrations.
66
VI.
APPENDICES
This
Reregistration
Eligibility
Document
is
supported
by
documents
that
are
presently
maintained
in
the
OPP
docket.
The
OPP
docket
is
located
in
Room
119,
Crystal
Mall
#2,
1921
Jefferson
Davis
Highway,
Arlington,
VA.
It
is
open
Monday
through
Friday,
excluding
legal
holidays
from
8:
30
am
to
4
pm.
All
documents,
in
hard
copy
form,
may
be
viewed
in
the
OPP
docket
room
or
downloaded
or
viewed
via
the
Internet
at
the
following
site:
www.
epa.
gov/
pesticides/
reregistration/
oxyfluorfen.
67
Appendix
A:
Use
Patterns
Eligible
for
Reregistration
Site
Application
Type
Application
Timing
Application
Equipment
Formulation
Example
[EPA
Reg.
No.]
Maximum
Single
Application
Rate
(ai)
Maximum
No.
of
Applications
Per
Season
Maximum
Seasonal
Rate
(ai)
Preharvest
Interval
(Days)
Use
Limitations
1
Almonds
(See
also
"Tree
nuts")
Directed
spray
application
Nondormant
Ground
equipment
1.6
lb/
gal
EC
[CA890012]
2
lb/
gal
EC
[CA960020]
1.5
lb/
A
Not
specified
(NS)
1.5
lb/
A
(nondormant
season)
30
Use
limited
to
CA.
Application
may
be
made
in
a
minimum
of
20
gal
of
water/
A
(minimum
of
10
gal/
A
for
certain
tank
mix
applications).
Application
may
be
made
alone
or
as
a
tank
mix
with
other
herbicides.
Chemigation
Nondormant
Flood
(basin)
irrigation,
low
volume
sprinkler
(microsprinkler)
or
drip
trickle
irrigation
2
lb/
gal
EC
[CA960020]
1.5
lb/
A
NS
1.5
lb/
A
(nondormant
season)
30
Use
limited
to
CA.
Apples
(See
"Pome
fruits")
Apricots
(See
"Stone
fruits")
Artichokes,
Globe
Directed
spray
application
Postemergence
Ground
equipment
1.6
lb/
gal
EC
[62719
400]
2
lb/
gal
EC
[62719
424]
1.5
lb/
A
1
1.
5
lb/
A
5
Applications
may
be
made
in
a
minimum
of
40
gal
of
water/
A.
The
use
of
any
treated
plants
for
feed
or
forage
and
the
feeding
or
grazing
of
any
treated
area
are
prohibited
for
the
1.6
lb/
gal
EC
formulation
only.
1.0
lb/
A
2
1.
5
lb/
A
5
The
first
application
is
made
to
susceptible
weed
seedlings
and
the
second
application
is
made
8
10
weeks
later.
Applications
may
be
made
in
a
minimum
of
40
gal
of
water/
A.
The
use
of
any
treated
plants
for
feed
or
forage
and
the
feeding
or
grazing
of
any
treated
area
are
prohibited
for
the
1.6
lb/
gal
EC
formulation
only.
Site
Application
Type
Application
Timing
Application
Equipment
Formulation
Example
[EPA
Reg.
No.]
Maximum
Single
Application
Rate
(ai)
Maximum
No.
of
Applications
Per
Season
Maximum
Seasonal
Rate
(ai)
Preharvest
Interval
(Days)
Use
Limitations
1
68
Avocados
Directed
spray
application
Dormant
Ground
equipment
1.6
lb/
gal
EC
[62719
400]
2
lb/
gal
EC
[62719
395]
[62719
424]
1.5
lb/
A
NS
1.5
lb/
A
NS
Applications
may
be
made
in
a
minimum
of
40
gal
of
water/
A.
Applications
may
be
made
alone
or
as
a
tank
mix
with
other
herbicides.
The
use
of
any
treated
plants
for
feed
or
forage,
the
feeding
or
grazing
of
any
treated
area,
and
application
after
buds
start
to
swell
or
when
foliage
or
fruit
are
present
are
prohibited.
Beech
nut
(See
"Tree
nuts")
Blackberries
Directed
spray
application
Early
season
(primocane
growth
4
to
6
inches)
or
dormant
Ground
equipment
1.6
lb/
gal
EC
[OR960005]
2
lb/
gal
EC
[OR960036]
[OR000028]
0.8
lb/
A
(early
season)
1.0
lb/
A
(dormant)
4
1.
5
lb/
A
15
Use
limited
to
OR.
Applications
may
be
made
in
a
minimum
of
50
gal
water/
A.
Brazil
nut
(See
"Tree
nuts")
Broccoli
Broadcast
application
Pretransplant
(preplant)
Ground
equipment
1.6
lb/
gal
EC
[62719
400]
2
lb/
gal
EC
[62719
424]
0.5
lb/
A
NS
0.5
lb/
A
NS
Applications
may
be
made
in
a
minimum
of
20
gal
of
water/
A.
Butternut
(See
"Tree
nuts")
Cabbage
Broadcast
application
Pretransplant
(preplant)
Ground
equipment
1.6
lb/
gal
EC
[62719
400]
2
lb/
gal
EC
[62719
424]
0.5
lb/
A
NS
0.5
lb/
A
NS
See
"Broccoli."
Site
Application
Type
Application
Timing
Application
Equipment
Formulation
Example
[EPA
Reg.
No.]
Maximum
Single
Application
Rate
(ai)
Maximum
No.
of
Applications
Per
Season
Maximum
Seasonal
Rate
(ai)
Preharvest
Interval
(Days)
Use
Limitations
1
69
Cacao
beans
(bearing
and
nonbearing)
Directed
spray
application
Postemergence
Ground
equipment
1.6
lb/
gal
EC
[62719
400]
2
lb/
gal
EC
[62719
424]
2.0
lb/
A
NS
6.0
lb/
A
1
Applications
may
be
made
in
a
minimum
of
15
gal
of
water/
A.
Directed
spray
application
Pretransplant
Ground
equipment
1.6
lb/
gal
EC
[62719
400]
2
lb/
gal
EC
[62719
424]
1.0
lb/
A
NS
6.0
lb/
A
1
Cashew
(See
"Tree
nuts")
Cauliflower
Broadcast
application
Pretransplant
(preplant)
Ground
equipment
1.6
lb/
gal
EC
[62719
400]
2
lb/
gal
EC
[62719
424]
0.5
lb/
A
NS
0.5
lb/
A
NS
See
"Broccoli."
Cherries
(See
"Stone
fruits")
Chestnut
(See
"Tree
nuts")
Chickpea
(Garbanzo
bean)
Broadcast
application
Preemergence
Ground
equipment
1.6
lb/
gal
EC
[62719
400]
2
lb/
gal
EC
[62719
424]
0.25
lb/
A
NS
NS
NS
Use
limited
to
CA.
Applications
may
be
made
in
a
minimum
of
25
gal
of
water/
A.
Feeding
of
bean,
vines,
or
hay
is
prohibited.
Site
Application
Type
Application
Timing
Application
Equipment
Formulation
Example
[EPA
Reg.
No.]
Maximum
Single
Application
Rate
(ai)
Maximum
No.
of
Applications
Per
Season
Maximum
Seasonal
Rate
(ai)
Preharvest
Interval
(Days)
Use
Limitations
1
70
Chickpea
(Garbanzo
bean)
(continued)
Broadcast
application
Preemergence
Ground
equipment
1.6
lb/
gal
EC
[CA920029]
2
lb/
gal
EC
[AZ000001]
[CA960022]
0.25
lb/
A
NS
NS
NS
Use
limited
to
AZ
and
CA.
Applications
may
be
made
in
a
minimum
of
20
gal
of
water/
A.
Chinquapin
(See
"Tree
nuts")
Coffee
(bearing
and
nonbearing)
Broadcast
application
(over
the
top)
Dormant
transplants
Ground
equipment
1.6
lb/
gal
EC
[62719
400]
2
lb/
gal
EC
[62719
424]
2.0
lb/
A
NS
6.0
lb/
A
1
Use
limited
to
HI.
Applications
may
be
made
in
a
minimum
of
30
gal
of
water/
A.
Applications
may
be
made
alone
or
as
a
tank
mix
with
other
herbicides.
Directed
spray
application
Postemergence
Ground
equipment
1.6
lb/
gal
EC
[62719
400]
2
lb/
gal
EC
[62719
424]
2.0
lb/
A
NS
6.0
lb/
A
1
Directed
spray
application
Pretransplant
Ground
equipment
1.6
lb/
gal
EC
[62719
400]
2
lb/
gal
EC
[62719
424]
1.0
lb/
A
NS
6.0
lb/
A
1
Site
Application
Type
Application
Timing
Application
Equipment
Formulation
Example
[EPA
Reg.
No.]
Maximum
Single
Application
Rate
(ai)
Maximum
No.
of
Applications
Per
Season
Maximum
Seasonal
Rate
(ai)
Preharvest
Interval
(Days)
Use
Limitations
1
71
Corn,
field
Directed
spray
application
Foliar/
postemergence
Ground
equipment
1.6
lb/
gal
EC
[62719
400]
2
lb/
gal
EC
[62719
395]
[62719
424]
[NC990007]
[SC000002]
0.75
lb/
A
(first
application)
0.5
lb/
A
(subsequent
applications)
NS
1.25
lb/
A
30
[62719
395]
[62719
400]
60
[62719
424]
[NC990007]
[SC000002]
Use
in
conjunction
with
the
USDA
"witchweed"
eradication
program
in
NC
and
SC.
Applications
may
be
made
in
a
minimum
of
10
gal
of
water/
A.
The
use
of
any
plants
from
a
treated
field
for
green
chop,
ensilage,
forage,
or
fodder
is
prohibited.
PHI
is
60
days.
Broadcast
application
Fallow
bed
Ground
or
aerial
equipment
1.6
lb/
gal
EC
[LA930011]
2
lb/
gal
EC
[AR960009]
[LA960012]
[MS960015]
0.5
lb/
A
NS
0.5
lb/
A
(per
fallow
season)
Not
applicable
(NA)
Use
limited
to
AR,
LA,
and
MS.
Application
may
be
made
in
a
minimum
of
20
gal
of
water/
A
using
ground
equipment
or
5
gal/
A
by
air.
Applications
may
be
made
alone
or
as
a
tank
mix
with
other
herbicides.
A
7
day
interval
from
treatment
to
planting
is
specified.
The
use
of
any
plants
from
a
treated
field
for
green
chop,
ensilage,
forage
or
fodder
or
the
feeding
or
grazing
of
animals
on
any
treated
area
is
prohibited.
PHI
is
60
days.
Cotton
Directed
spray
application
Postemergence
Ground
equipment
1.6
lb/
gal
EC
[62719
400]
[VA930010]
2
lb/
gal
EC
[62719
395]
[62719
424]
0.5
lb/
A
NS
0.5
lb/
A
(single
or
multiple
applications)
90
[62719
400]
[62719
424]
[VA930010]
NS
[62719
395]
Use
limited
to
AL,
AR,
GA,
LA,
MS,
MO,
NM,
NC,
OK,
SC,
TN,
TX,
and
VA
(Southern
cotton).
Applications
may
be
made
in
a
minimum
of
20
gal
of
water/
A.
Applications
may
be
made
alone
or
as
a
tank
mix
with
other
herbicides.
Application
after
initiation
of
bloom
is
prohibited.
1.0
lb/
A
(multiple
applications)
0.5
lb/
A
(single
application)
75
[62719
400]
[62719
424]
NS
[62719
395]
Use
limited
to
AZ
and
CA
(Western
cotton).
Applications
may
be
made
in
a
minimum
of
20
gal
of
water/
A.
Applications
may
be
made
alone
or
as
a
tank
mix
with
other
herbicides.
Application
after
initiation
of
bloom
is
prohibited.
Site
Application
Type
Application
Timing
Application
Equipment
Formulation
Example
[EPA
Reg.
No.]
Maximum
Single
Application
Rate
(ai)
Maximum
No.
of
Applications
Per
Season
Maximum
Seasonal
Rate
(ai)
Preharvest
Interval
(Days)
Use
Limitations
1
72
Cotton
(continued)
Broadcast
application
Fallow
bed
Aerial
equipment
2
lb/
gal
EC
[62719
395]
0.5
lb/
A
NS
0.5
lb/
A
(per
fallow
season)
NA
Use
limited
to
AZ
and
CA.
Applications
may
be
made
in
a
minimum
of
10
gal
of
water/
A
(minimum
of
5
gal/
A
for
certain
tank
mix
applications).
Applications
may
be
made
alone
or
as
a
tank
mix
with
other
herbicides.
A
14
day
interval
from
treatment
to
incorporation
and
planting
is
specified.
Broadcast
application
Fallow
bed
Ground
equipment
2
lb/
gal
EC
[62719
395]
0.5
lb/
A
NS
0.5
lb/
A
(per
fallow
season)
NA
Applications
may
be
made
in
a
minimum
of
20
gal
of
water/
A.
Applications
may
be
made
alone
or
as
a
tank
mix
with
other
herbicides.
A
14
day
interval
from
treatment
to
incorporation
and
planting
is
specified.
Broadcast
application
Fallow
bed
Ground
or
aerial
equipment
1.6
lb/
gal
EC
[62719
400]
2
lb/
gal
EC
[62719
424]
0.5
lb/
A
NS
0.5
lb/
A
(per
fallow
season)
NA
Applications
may
be
made
in
a
minimum
of
20
gal
of
water/
A
using
ground
equipment
or
5
gal/
A
by
air
(minimum
of
10
gal/
A
by
air
in
CA).
Applications
may
be
made
alone
or
as
a
tank
mix
with
other
herbicides.
A
7
day
interval
from
treatment
to
planting
is
specified.
Crabapples
(See
"Pome
fruits")
Dates
Directed
spray
application
Dormant
Ground
equipment
1.6
lb/
gal
EC
[62719
400]
2
lb/
gal
EC
[62719
395]
[62719
424]
1.5
lb/
A
NS
1.5
lb/
A
NS
Applications
may
be
made
in
a
minimum
of
40
gal
of
water/
A.
Applications
may
be
made
alone
or
as
a
tank
mix
with
other
herbicides.
The
use
of
any
treated
plants
for
feed
or
forage,
the
feeding
or
grazing
of
any
treated
area,
and
application
after
buds
start
to
swell
or
when
foliage
or
fruit
are
present
are
prohibited.
Fallow
land
Broadcast
application
Fallow
bed
Ground
or
aerial
equipment
1.6
lb/
gal
EC
[62719
400]
2
lb/
gal
EC
[62719
424]
0.5
lb/
A
NS
0.5
lb/
A
NA
Applications
may
be
made
in
a
minimum
of
20
gal
of
water/
A
using
ground
equipment
or
10
gal/
A
by
air.
Applications
may
be
made
alone
or
as
a
tank
mix
with
other
herbicides.
Site
Application
Type
Application
Timing
Application
Equipment
Formulation
Example
[EPA
Reg.
No.]
Maximum
Single
Application
Rate
(ai)
Maximum
No.
of
Applications
Per
Season
Maximum
Seasonal
Rate
(ai)
Preharvest
Interval
(Days)
Use
Limitations
1
73
Fallow
land
(continued)
Broadcast
application
Fallow
bed
Ground
equipment
1.6
lb/
gal
EC
[62719
400]
2
lb/
gal
EC
[62719
395]
[62719
424]
0.5
lb/
A
NS
NS
NA
Use
limited
to
ID,
OR,
and
WA.
Use
is
restricted
to
summer
fallow
land
that
will
be
planted
back
the
following
year
to
barley,
oats,
or
winter
wheat.
Applications
may
be
made
in
a
minimum
of
20
gal
of
water/
A.
Applications
may
be
made
alone
or
as
a
tank
mix
with
other
herbicides.
Feijoa
Directed
spray
application
Dormant
Ground
equipment
1.6
lb/
gal
EC
[62719
400]
2
lb/
gal
EC
[62719
424]
1.5
lb/
A
NS
1.5
lb/
A
NS
Applications
may
be
made
in
a
minimum
of
40
gal
of
water/
A.
Applications
may
be
made
alone
or
as
a
tank
mix
with
other
herbicides.
The
use
of
any
treated
plants
for
feed
or
forage,
the
feeding
or
grazing
of
any
treated
area,
and
application
after
buds
start
to
swell
or
when
foliage
or
fruit
are
present
are
prohibited.
Figs
Directed
spray
application
Dormant
Ground
equipment
1.6
lb/
gal
EC
[62719
400]
2
lb/
gal
EC
[62719
395]
[62719
424]
1.5
lb/
A
NS
1.5
lb/
A
NS
Applications
may
be
made
in
a
minimum
of
40
gal
of
water/
A.
Applications
may
be
made
alone
or
as
a
tank
mix
with
other
herbicides.
The
use
of
any
treated
plants
for
feed
or
forage,
the
feeding
or
grazing
of
any
treated
area,
and
application
after
buds
start
to
swell
or
when
foliage
or
fruit
are
present
are
prohibited.
Filberts
(See
"Tree
Nuts")
Garbanzo
bean
(see
"Chickpea")
Garlic
Broadcast
or
band
application
Postemergence
to
seeded
garlic
(at
least
2
true
leaves)
Ground
equipment
1.6
lb/
gal
EC
[62719
400]
2
lb/
gal
EC
[62719
424]
0.25
lb/
A
NS
0.5
lb/
A
60
Use
limited
to
direct
seeded
garlic
in
Western
states
of
AZ,
CA,
CO,
ID,
NV,
NM,
OR,
TX,
UT,
and
WA.
Applications
may
be
made
in
a
minimum
of
40
gal
of
water/
A.
For
use
on
dry
bulb
garlic
only;
use
on
garlic
grown
for
seed
is
prohibited.
Site
Application
Type
Application
Timing
Application
Equipment
Formulation
Example
[EPA
Reg.
No.]
Maximum
Single
Application
Rate
(ai)
Maximum
No.
of
Applications
Per
Season
Maximum
Seasonal
Rate
(ai)
Preharvest
Interval
(Days)
Use
Limitations
1
74
Garlic
(continued)
Broadcast
or
band
application
Postemergence
to
seeded
garlic
(at
least
3
true
leaves)
Ground
equipment
1.6
lb/
gal
EC
[62719
400]
2
lb/
gal
EC
[62719
424]
0.06
lb/
A
NS
0.5
lb/
A
60
Use
limited
to
direct
seeded
garlic
in
Northeastern
states
of
CT,
ME,
MA,
NH,
NJ,
NY,
RI,
and
VT.
Applications
may
be
made
in
a
minimum
of
40
gal
of
water/
A.
For
use
on
dry
bulb
garlic
only;
use
on
garlic
grown
for
seed
is
prohibited.
Broadcast
or
band
application
Postemergence
to
seeded
garlic
(at
least
2
true
leaves)
Ground
equipment
1.6
lb/
gal
EC
[62719
400]
2
lb/
gal
EC
[62719
424]
0.12
lb/
A
NS
0.5
lb/
A
60
Use
limited
to
direct
seeded
garlic
in
all
other
states
not
listed
above.
Applications
may
be
made
in
a
minimum
of
40
gal
of
water/
A.
For
use
on
dry
bulb
garlic
only;
use
on
garlic
grown
for
seed
is
prohibited.
Broadcast
or
band
application
After
transplanting
Ground
equipment
1.6
lb/
gal
EC
[62719
400]
2
lb/
gal
EC
[62719
424]
0.5
lb/
A
NS
0.5
lb/
A
60
Use
limited
to
transplanted
garlic
for
all
states
except
the
Northeastern
states
listed
above.
Applications
may
be
made
in
a
minimum
of
40
gal
of
water/
A.
For
use
on
dry
bulb
garlic
only;
use
on
garlic
grown
for
seed
is
prohibited.
0.06
lb/
A
NS
0.5
lb/
A
60
Use
limited
to
transplanted
garlic
in
the
Northeastern
states
listed
above.
Applications
may
be
made
in
a
minimum
of
40
gal
of
water/
A.
For
use
on
dry
bulb
garlic
only;
use
on
garlic
grown
for
seed
is
prohibited.
Broadcast
application
Preemergence
Ground
or
aerial
equipment
1.6
lb/
gal
EC
[CA920018]
2
lb/
gal
EC
[CA960021]
0.25
lb/
A
NS
0.5
lb/
A
60
Use
limited
to
CA.
Applications
may
be
made
in
a
minimum
of
20
gal
of
water/
A
using
ground
equipment
or
10
gal/
A
by
air.
For
use
on
dry
bulb
garlic
only.
Site
Application
Type
Application
Timing
Application
Equipment
Formulation
Example
[EPA
Reg.
No.]
Maximum
Single
Application
Rate
(ai)
Maximum
No.
of
Applications
Per
Season
Maximum
Seasonal
Rate
(ai)
Preharvest
Interval
(Days)
Use
Limitations
1
75
Garlic
(continued)
Directed
spray
application
Postemergence
Ground
equipment
1.6
lb/
gal
EC
[CA920018]
2
lb/
gal
EC
[CA960021]
[NV990001]
0.25
lb/
A
NS
0.5
lb/
A
60
Use
limited
to
CA
and
NV.
Applications
may
be
made
in
a
minimum
of
20
gal
of
water/
A.
For
use
on
dry
bulb
garlic
only.
Chemigation
Preemergence
or
postemergence
Sprinkler
irrigation
1.6
lb/
gal
EC
[CA920018]
2
lb/
gal
EC
[CA960021]
0.25
lb/
A
NS
0.5
lb/
A
60
Use
limited
to
CA.
For
use
on
dry
bulb
garlic
only.
Grapes
Directed
spray
application
Dormant
Ground
equipment
1.6
lb/
gal
EC
[62719
400]
2
lb/
gal
EC
[62719
395]
[62719
424]
1.5
lb/
A
NS
1.5
lb/
A
NS
Applications
may
be
made
in
a
minimum
of
40
gal
of
water/
A.
Applications
may
be
made
alone
or
as
a
tank
mix
with
other
herbicides.
The
use
of
any
treated
plants
for
feed
or
forage,
the
feeding
or
grazing
of
any
treated
area,
and
application
after
buds
start
to
swell
or
when
foliage
or
fruit
are
present
are
prohibited.
Directed
spray
or
broadcast
(over
the
top)
application
Dormant
(nonbearing)
Ground
equipment
1.6
lb/
gal
EC
[CA950008]
2
lb/
gal
EC
[CA960023]
[WA970023]
1.5
lb/
A
NS
NS
NS
Use
limited
to
CA
and
WA.
Applications
may
be
made
in
a
minimum
of
40
gal
of
water/
A.
Application
after
buds
start
to
swell
is
prohibited.
Site
Application
Type
Application
Timing
Application
Equipment
Formulation
Example
[EPA
Reg.
No.]
Maximum
Single
Application
Rate
(ai)
Maximum
No.
of
Applications
Per
Season
Maximum
Seasonal
Rate
(ai)
Preharvest
Interval
(Days)
Use
Limitations
1
76
Grapes
(continued)
Directed
spray
application
Nondormant
Ground
equipment
2
lb/
gal
EC
[CA970026]
0.5
lb/
A
NS
1.5
lb/
A
14
Use
limited
to
CA
as
a
nondormant
application
to
wine
grapes
and
raisin
grapes
only.
Applications
may
be
made
in
a
minimum
of
20
gal
of
water/
A
(minimum
of
10
gal/
A
for
certain
tank
mix
applications).
Application
may
be
made
alone
or
as
a
tank
mix
with
other
herbicides.
2
lb/
gal
EC
[OR000001]
[WA970013]
0.5
lb/
A
NS
1.5
lb/
A
60
Use
limited
to
OR
and
WA
as
a
nondormant
application
to
wine
and
processing
grapes
only.
Applications
may
be
made
in
a
minimum
o
f
50
gal
of
water/
A.
Application
may
be
made
alone
or
as
a
tank
mix
with
other
herbicides.
Chemigation
Nondormant
Low
volume
sprinkler
(microsprinkler)
or
drip
trickle
irrigation
2
lb/
gal
EC
[CA970026]
[WA970024]
0.5
lb/
A
NS
1.5
lb/
A
14
Use
limited
to
CA
and
WA
as
a
nondormant
application
to
grapes
grown
for
processing
(includes
juice,
wine,
and
raisin
grapes
only).
Grasses
grown
for
seed
Broadcast
application
Ground
equipment
2
lb/
gal
EC
[OR990006]
[WA990035]
0.125
0.375
lb/
A
2
0.
375
lb/
A
150
Use
limited
to
OR
and
WA
for
grass
grown
for
seed
(including
Kentucky
bluegrass,
tall
fescue,
orchardgrass,
bentgrass,
and
perennial
ryegrass).
Applications
may
be
made
in
a
minimum
of
20
gal
of
water/
A.
Applications
may
be
made
alone
or
as
a
tank
mix
with
other
herbicides.
A
150
day
pregrazing
interval
(PGI)
has
been
established.
2
lb/
gal
EC
[OR990006]
0.12
lb/
A
1
0.
12
lb/
A
150
Use
limited
to
OR
for
grass
grown
for
seed
(including
fine
fescues:
chewing,
creeping
red,
and
hard
types).
Applications
may
be
made
in
a
minimum
of
20
gal
of
water/
A.
Applications
may
be
made
alone
or
as
a
tank
mix
with
other
herbicides.
A
150
day
pregrazing
interval
(PGI)
has
been
established.
Site
Application
Type
Application
Timing
Application
Equipment
Formulation
Example
[EPA
Reg.
No.]
Maximum
Single
Application
Rate
(ai)
Maximum
No.
of
Applications
Per
Season
Maximum
Seasonal
Rate
(ai)
Preharvest
Interval
(Days)
Use
Limitations
1
77
2
lb/
gal
EC
[OR990036]
0.0375
lb/
A
1
NS
150
Use
limited
to
OR
for
grass
grown
for
seed
(including
perennial
ryegrass
and
tall
fescue).
Applications
may
be
made
in
a
minimum
of
20
gal
of
water/
A.
Applications
may
be
made
alone
or
as
a
tank
mix
with
other
herbicides.
A
150
day
pregrazing
interval
(PGI)
has
been
established.
Guavas
(bearing
and
nonbearing)
Directed
spray
application
Postemergence
(after
new
foliage
has
hardened
off)
Ground
equipment
1.6
lb/
gal
EC
[62719
400]
2
lb/
gal
EC
[62719
424]
2.0
lb/
A
NS
4.0
lb/
A
1
Use
limited
to
HI.
Applications
may
be
made
in
a
minimum
of
15
gal
of
water/
A.
Applications
may
be
made
alone
or
as
a
tank
mix
with
other
herbicides.
Hickory
Nut
(See
"Tree
Nuts")
Horseradish
Broadcast
application
Preemergence
Ground
equipment
1.6
lb/
gal
EC
[62719
400]
2
lb/
gal
EC
[62719
424]
0.5
lb/
A
NS
1.5
lb/
A
NS
Applications
may
be
made
in
a
minimum
of
20
gal
of
water/
A.
Kiwifruit
Directed
spray
application
Dormant
Ground
equipment
1.6
lb/
gal
EC
[62719
400]
2
lb/
gal
EC
[62719
395]
[62719
424]
1.5
lb/
A
NS
1.5
lb/
A
NS
Applications
may
be
made
in
a
minimum
of
40
gal
of
water/
A.
Applications
may
be
made
alone
or
as
a
tank
mix
with
other
herbicides.
The
use
of
any
treated
plants
for
feed
or
forage,
the
feeding
or
grazing
of
any
treated
area,
and
application
after
buds
start
to
swell
or
when
foliage
or
fruit
are
present
are
prohibited.
Loquat
(See
"Pome
fruits")
Site
Application
Type
Application
Timing
Application
Equipment
Formulation
Example
[EPA
Reg.
No.]
Maximum
Single
Application
Rate
(ai)
Maximum
No.
of
Applications
Per
Season
Maximum
Seasonal
Rate
(ai)
Preharvest
Interval
(Days)
Use
Limitations
1
78
Macadamia
Nut
(bearing
and
nonbearing;
see
also
"Tree
nuts")
Directed
spray
application
Postemergence
(after
new
foliage
has
hardened
off)
Ground
equipment
2
lb/
gal
EC
[HI960010]
2.0
lb/
A
1.0
lb/
A
(lava
soil)
NS
4.0
lb/
A
7
Use
limited
to
HI.
Applications
may
be
made
in
a
minimum
of
15
gal
of
water/
A.
Applications
may
be
made
alone
or
as
a
tank
mix
with
other
herbicides.
Feeding
or
grazing
of
animals
on
any
treated
area
is
prohibited.
Mayhaws
(See
"Pome
fruits")
Nectarines
(See
"Stone
fruits")
Olive
Directed
spray
application
Dormant
Ground
equipment
1.6
lb/
gal
EC
[62719
400]
2
lb/
gal
EC
[62719
395]
[62719
424]
1.5
lb/
A
NS
1.5
lb/
A
NS
Applications
may
be
made
in
a
minimum
of
40
gal
of
water/
A.
Applications
may
be
made
alone
or
as
a
tank
mix
with
other
herbicides.
The
use
of
any
treated
plants
for
feed
or
forage,
the
feeding
or
grazing
of
any
treated
area,
and
application
after
buds
start
to
swell
or
when
foliage
or
fruit
are
present
are
prohibited.
Onions,
bulb
Broadcast
or
band
application
Postemergence
to
seeded
onions
(at
least
2
true
leaves)
Ground
equipment
1.6
lb/
gal
EC
[62719
400]
2
lb/
gal
EC
[62719
424]
0.25
lb/
A
NS
0.5
lb/
A
45
Use
limited
to
direct
seeded
onions
in
Western
states
of
AZ,
CA,
CO,
ID,
NV,
NM,
OR,
TX,
UT,
and
WA.
Applications
may
be
made
in
a
minimum
of
40
gal
of
water/
A.
Broadcast
or
band
application
Postemergence
to
seeded
onions
(at
least
3
true
leaves)
Ground
equipment
1.6
lb/
gal
EC
[62719
400]
2
lb/
gal
EC
[62719
424]
0.06
lb/
A
NS
0.5
lb/
A
45
Use
limited
to
direct
seeded
onions
in
Northeastern
states
of
CT,
ME,
MA,
NH,
NJ,
NY,
RI,
and
VT.
Applications
may
be
made
in
a
minimum
of
40
gal
of
water/
A.
Site
Application
Type
Application
Timing
Application
Equipment
Formulation
Example
[EPA
Reg.
No.]
Maximum
Single
Application
Rate
(ai)
Maximum
No.
of
Applications
Per
Season
Maximum
Seasonal
Rate
(ai)
Preharvest
Interval
(Days)
Use
Limitations
1
79
Onions,
bulb
(continued)
Broadcast
or
band
application
Postemergence
to
seeded
onions
(at
least
2
true
leaves)
Ground
equipment
1.6
lb/
gal
EC
[62719
400]
2
lb/
gal
EC
[62719
424]
0.12
lb/
A
NS
0.5
lb/
A
45
Use
limited
to
direct
seeded
onions
in
all
other
states
not
listed
above.
Applications
may
be
made
in
a
minimum
of
40
gal
of
water/
A.
Broadcast
or
band
application
After
transplanting
Ground
equipment
1.6
lb/
gal
EC
[62719
400]
2
lb/
gal
EC
[62719
424]
0.5
lb/
A
NS
0.5
lb/
A
45
Use
limited
to
transplanted
onions
for
all
states
except
the
Northeastern
states
listed
above.
Applications
may
be
made
in
a
minimum
of
40
gal
of
water/
A.
0.06
lb/
A
NS
0.5
lb/
A
45
Use
limited
to
transplanted
onions
in
the
Northeastern
states
listed
above.
Applications
may
be
made
in
a
minimum
of
40
gal
of
water/
A.
Broadcast
or
band
application
Pre
transplanting
Ground
equipment
1.6
lb/
gal
EC
[62719
400]
2
lb/
gal
EC
[62719
424]
0.5
lb/
A
NS
0.5
lb/
A
45
Use
prohibited
in
Northeastern
and
Western
states
listed
above,
except
if
specifically
directed
on
other
approved
supplemental
labeling.
Applications
may
be
made
in
a
minimum
of
40
gal
of
water/
A.
Broadcast
application
Pre
transplanting
Ground
equipment
1.6
lb/
gal
EC
[GA890006]
0.5
lb/
A
NS
0.5
lb/
A
NS
Use
limited
to
GA.
Applications
may
be
made
in
a
minimum
of
40
gal
of
water/
A.
The
use
of
any
treated
plants
for
feed
or
forage
and
the
feeding
or
grazing
of
any
treated
area
are
prohibited.
Chemigation
Postemergence
(at
least
2
true
leaves)
or
after
transplanting
Sprinkler
irrigation
1.6
lb/
gal
EC
[CA880034]
[OR910026]
2
lb/
gal
EC
[OR970008]
0.25
lb/
A
NS
0.5
lb/
A
45
(OR)
60
(CA)
Use
limited
to
CA
and
OR.
Site
Application
Type
Application
Timing
Application
Equipment
Formulation
Example
[EPA
Reg.
No.]
Maximum
Single
Application
Rate
(ai)
Maximum
No.
of
Applications
Per
Season
Maximum
Seasonal
Rate
(ai)
Preharvest
Interval
(Days)
Use
Limitations
1
80
Onions,
bulb
(continued)
Chemigation
Postemergence
(at
least
2
true
leaves)
Sprinkler
irrigation
2
lb/
gal
EC
[CA960026]
[WA960033]
0.25
lb/
A
NS
0.5
lb/
A
45
Use
limited
to
CA
and
WA.
Chemigation
After
transplanting
Sprinkler
irrigation
2
lb/
gal
EC
[WA960033]
0.5
lb/
A
NS
0.5
lb/
A
45
Use
limited
to
WA.
Onions
Grown
for
Seed
Broadcast
application
Postemergence
(at
least
4
true
leaves)
Ground
equipment
1.6
lb/
gal
EC
[62719
400]
2
lb/
gal
EC
[62719
424]
0.03
lb/
A
NS
0.5
lb/
A
60
Use
limited
to
onions
grown
for
seed
in
Northeastern
states
of
CT,
ME,
MA,
NH,
NJ,
NY,
RI,
&
VT.
Applications
may
be
made
in
a
minimum
of
40
gal/
A.
Broadcast
application
Postemergence
(at
least
3
true
leaves)
Ground
equipment
1.6
lb/
gal
EC
[62719
400]
2
lb/
gal
EC
[62719
424]
0.12
lb/
A
NS
0.5
lb/
A
60
Use
limited
to
onions
grown
for
seed
in
all
other
states
not
listed
above.
Applications
may
be
made
in
a
minimum
of
40
gal/
A.
Ornamental
Plants
Field
grown
ornamentals
and
Containerized
ornamentals
Broadcast
application
Postemergence
(at
least
4
true
leaves)
Ground
equipment
2%
Granular
[538
172]
2
lb/
gal
EC
[62719
424]
1.5
lb/
A
NS
4.5
lb/
A
NA
Site
Application
Type
Application
Timing
Application
Equipment
Formulation
Example
[EPA
Reg.
No.]
Maximum
Single
Application
Rate
(ai)
Maximum
No.
of
Applications
Per
Season
Maximum
Seasonal
Rate
(ai)
Preharvest
Interval
(Days)
Use
Limitations
1
81
Ornamental
Plants
(continued)
Containerized
ornamentals
Broadcast
application
Postemergence
(at
least
4
true
leaves)
Ground
equipment
2%
Granular
[538
172]
2.0
lb/
A
NS
6.0
lb/
A
NA
Residential
ornamentals
Broadcast
application
Ground
equipment
0.25%
Solution
[239
2356]
1.5
lb/
A
NS
3.0
lb/
A
NA
Papayas
Directed
spray
application
Postemergence
Ground
equipment
1.6
lb/
gal
EC
[62719
400]
2
lb/
gal
EC
[62719
424]
1.0
lb/
A
NS
3.0
lb/
A
1
Use
limited
to
HI.
Initial
application
should
occur
no
earlier
than
4
months
after
transplanting
or
6
months
after
direct
seeding.
Applications
may
be
made
in
minimum
of
15
gal
of
water/
A
and
repeated
at
4
month
intervals.
Peaches
(See
"Stone
fruits")
Pears
(See
"Pome
fruits")
Pecans
(See
"Tree
nuts")
Site
Application
Type
Application
Timing
Application
Equipment
Formulation
Example
[EPA
Reg.
No.]
Maximum
Single
Application
Rate
(ai)
Maximum
No.
of
Applications
Per
Season
Maximum
Seasonal
Rate
(ai)
Preharvest
Interval
(Days)
Use
Limitations
1
82
Peppermint
Broadcast
or
band
application
Dormant
Ground
equipment
1.6
lb/
gal
EC
[62719
400]
2
lb/
gal
EC
[62719
395]
1.5
lb/
A
1
NS
NA
Use
limited
to
OR
and
WA
(East
of
Cascades)
and
western
ID.
Application
may
be
made
in
a
minimum
of
20
gal
of
water/
A.
0.75
lb/
A
1
NS
NA
Use
limited
to
western
OR
(Willamette
Valley).
Application
may
be
made
in
a
minimum
of
20
gal
of
water/
A.
1.6
lb/
gal
EC
[CA930014]
[NV930002]
[SD940001]
2
lb/
gal
EC
[MT960003]
[ND980001]
1.5
lb/
A
NS
1.5
lb/
A
NA
Use
limited
to
CA,
MT,
ND,
NV,
and
SD.
Applications
may
be
made
in
a
minimum
of
20
gal
of
water/
A.
Broadcast
application
Dormant
Ground
equipment
2
lb/
gal
EC
[62719
424]
1.5
lb/
A
1
NS
NA
Use
limited
to
OR
and
WA
(East
of
Cascades)
and
CA,
ID,
MT,
NV,
SD,
and
UT.
Application
may
be
made
in
a
minimum
of
20
gal
of
water/
A.
0.75
lb/
A
1
NS
NA
Use
limited
to
western
OR
(Willamette
Valley).
Application
may
be
made
in
a
minimum
of
20
gal
of
water/
A.
Broadcast
application
Dormant
Ground
equipment
2
lb/
gal
EC
[SD960007]
1.5
lb/
A
1
NS
NA
Use
limited
to
SD.
Application
may
be
made
in
a
minimum
of
20
gal
of
water/
A.
Site
Application
Type
Application
Timing
Application
Equipment
Formulation
Example
[EPA
Reg.
No.]
Maximum
Single
Application
Rate
(ai)
Maximum
No.
of
Applications
Per
Season
Maximum
Seasonal
Rate
(ai)
Preharvest
Interval
(Days)
Use
Limitations
1
83
Peppermint
(continued)
Broadcast
application
Preemergence
(dormant)
Ground
equipment
1.6
lb/
gal
EC
[IN840003]
[WI950001]
2
lb/
gal
EC
[IN960004]
[MI970002]
[WI960009]
1.5
lb/
A
NS
NS
NA
Use
limited
to
IN,
MI,
and
WI
for
mint
grown
in
muck
soil
(
$
20%
organic
matter).
Applications
may
be
made
in
a
minimum
of
20
gal
of
water/
A.
The
use
of
any
treated
plants
for
feed
or
forage
and
the
feeding
or
grazing
of
any
treated
area
are
prohibited.
Persimmons
Directed
spray
application
Dormant
Ground
equipment
1.6
lb/
gal
EC
[62719
400]
2
lb/
gal
EC
[62719
424]
1.5
lb/
A
NS
2.0
lb/
A
NS
Applications
may
be
made
in
a
minimum
of
40
gal
of
water/
A.
Applications
may
be
made
alone
or
as
a
tank
mix
with
other
herbicides.
The
use
of
any
treated
plants
for
feed
or
forage,
the
feeding
or
grazing
of
any
treated
area,
and
application
after
buds
start
to
swell
or
when
foliage
or
fruit
are
present
are
prohibited.
Pistachios
(See
also
"Tree
Nuts")
Directed
spray
application
Nondormant
Ground
equipment
1.6
lb/
gal
EC
[CA950007]
2
lb/
gal
EC
[CA960019]
1.5
lb/
A
NS
1.5
lb/
A
(nondormant
season)
7
Use
limited
to
CA.
Application
may
be
made
in
a
minimum
of
20
gal
of
water/
A
(minimum
of
10
gal/
A
for
certain
tank
mix
applications).
Application
may
be
made
alone
or
as
a
tank
mix
with
other
herbicides.
Chemigation
Nondormant
Flood
(basin)
irrigation
1.6
lb/
gal
EC
[CA950007]
1.5
lb/
A
NS
1.5
lb/
A
(nondormant
season)
7
Use
limited
to
CA.
Chemigation
Nondormant
Flood
(basin)
irrigation,
low
volume
sprinkler
(microsprinkler)
or
drip
trickle
irrigation
2
lb/
gal
EC
[CA960019]
Site
Application
Type
Application
Timing
Application
Equipment
Formulation
Example
[EPA
Reg.
No.]
Maximum
Single
Application
Rate
(ai)
Maximum
No.
of
Applications
Per
Season
Maximum
Seasonal
Rate
(ai)
Preharvest
Interval
(Days)
Use
Limitations
1
84
Plums
(See
"Stone
fruits")
Pome
fruits
(including
apple,
crabapple,
loquat,
mayhaws,
pear,
and
quince)
Directed
spray
application
Dormant
Ground
equipment
1.6
lb/
gal
EC
[62719
400]
2
lb/
gal
EC
[62719
395]
[62719
424]
1.5
lb/
A
NS
1.5
lb/
A
NS
Applications
may
be
made
in
a
minimum
of
40
gal
of
water/
A.
Applications
may
be
made
alone
or
as
a
tank
mix
with
other
herbicides.
The
use
of
any
treated
plants
for
feed
or
forage,
the
feeding
or
grazing
of
any
treated
area,
and
application
after
buds
start
to
swell
or
when
foliage
or
fruit
are
present
are
prohibited.
Pomegranates
Directed
spray
application
Dormant
Ground
equipment
1.6
lb/
gal
EC
[62719
400]
2
lb/
gal
EC
[62719
395]
[62719
424]
1.5
lb/
A
NS
1.5
lb/
A
NS
Applications
may
be
made
in
a
minimum
of
40
gal
of
water/
A.
Applications
may
be
made
alone
or
as
a
tank
mix
with
other
herbicides.
The
use
of
any
treated
plants
for
feed
or
forage,
the
feeding
or
grazing
of
any
treated
area,
and
application
after
buds
start
to
swell
or
when
foliage
or
fruit
are
present
are
prohibited.
Prunes
(See
"Stone
fruits")
Quince
(See
"Pome
fruits")
Raspberries
Directed
spray
application
Early
season
(primocane
growth
4
to
6
inches)
Ground
equipment
1.6
lb/
gal
EC
[OR960006]
0.8
lb/
A
2
1.
2
lb/
A
50
Use
limited
to
OR
and
WA.
Applications
may
be
made
in
a
minimum
of
50
gal
water/
A.
2
lb/
gal
EC
[OR960037]
[WA960034]
0.75
lb/
A
2
1.
25
lb/
A
50
Site
Application
Type
Application
Timing
Application
Equipment
Formulation
Example
[EPA
Reg.
No.]
Maximum
Single
Application
Rate
(ai)
Maximum
No.
of
Applications
Per
Season
Maximum
Seasonal
Rate
(ai)
Preharvest
Interval
(Days)
Use
Limitations
1
85
Soybeans
Broadcast
application
(Conservation
tillage)
Early
preplant
Ground
equipment
1.6
lb/
gal
EC
[62719
400]
2
lb/
gal
EC
[62719
395]
[62719
424]
0.75
lb/
A
2
0.75
lb/
A
(all
uses)
NS
Use
prohibited
in
CA.
Application
should
be
made
approximately
14
days
prior
to
planting.
Broadcast
application
(No
till)
Preemergence
Ground
equipment
1.6
lb/
gal
EC
[62719
400]
2
lb/
gal
EC
[62719
395]
[62719
424]
0.5
lb/
A
2
0.75
lb/
A
(all
uses)
0.5
lb/
A
(preemergent
uses)
NS
Use
prohibited
in
CA.
Application
should
be
made
within
1
day
of
planting.
Application
may
be
made
in
a
minimum
of
20
gal
of
water/
A.
Application
may
be
made
alone
or
as
a
tank
mix
with
other
herbicides.
Broadcast
application
(Conventional
till)
Preemergence
Ground
equipment
1.6
lb/
gal
EC
[62719
400]
2
lb/
gal
EC
[62719
395]
[62719
424]
0.38
lb/
A
2
0.75
lb/
A
(all
uses)
0.5
lb/
A
(preemergent
uses)
NS
Directed
spray
application
(Conventional
till)
Postemergence
Ground
equipment
1.6
lb/
gal
EC
[62719
400]
2
lb/
gal
EC
[62719
395]
[62719
424]
0.25
lb/
A
2
0.75
lb/
A
(all
uses)
0.5
lb/
A
(preemergent
uses)
NS
Use
prohibited
in
CA.
Application
should
be
made
when
soybean
plants
are
a
minimum
of
8
inches
tall
and
before
blooms
appear.
Application
may
be
made
in
a
minimum
of
20
gal
of
water/
A.
Application
may
be
made
alone
or
as
a
tank
mix
with
other
herbicides.
Site
Application
Type
Application
Timing
Application
Equipment
Formulation
Example
[EPA
Reg.
No.]
Maximum
Single
Application
Rate
(ai)
Maximum
No.
of
Applications
Per
Season
Maximum
Seasonal
Rate
(ai)
Preharvest
Interval
(Days)
Use
Limitations
1
86
Soybeans
(continued)
Broadcast
application
Fallow
bed
Ground
or
aerial
equipment
1.6
lb/
gal
EC
[62719
400]
2
lb/
gal
EC
[62719
424]
0.5
lb/
A
NS
0.5
lb/
A
(per
fallow
season)
NA
Use
prohibited
in
CA.
Applications
may
be
made
in
a
minimum
of
20
gal
of
water/
A
using
ground
equipment
or
5
gal/
A
by
air.
Applications
may
be
made
alone
or
as
a
tank
mix
with
other
herbicides.
A
7
day
interval
from
treatment
to
planting
is
specified.
Spearmint
Broadcast
or
band
application
Dormant
Ground
equipment
1.6
lb/
gal
EC
[62719
400]
2
lb/
gal
EC
[62719
395]
1.5
lb/
A
1
NS
NA
See
"Peppermint."
Broadcast
application
Dormant
Ground
equipment
2
lb/
gal
EC
[62719
424]
[SD960007]
1.5
lb/
A
1
NS
NA
See
"Peppermint."
Broadcast
or
band
application
Dormant
Ground
equipment
1.6
lb/
gal
EC
[CA930014]
[NV930002]
[SD940001]
2
lb/
gal
EC
[MT960003]
[ND980001]
1.5
lb/
A
NS
NS
NA
See
"Peppermint."
Site
Application
Type
Application
Timing
Application
Equipment
Formulation
Example
[EPA
Reg.
No.]
Maximum
Single
Application
Rate
(ai)
Maximum
No.
of
Applications
Per
Season
Maximum
Seasonal
Rate
(ai)
Preharvest
Interval
(Days)
Use
Limitations
1
87
Spearmint
(continued)
Broadcast
application
Preemergence
(dormant)
Ground
equipment
1.6
lb/
gal
EC
[IN840003]
[WI950001]
2
lb/
gal
EC
[IN960004]
[MI970002]
[WI960009]
1.5
lb/
A
NS
NS
NA
See
"Peppermint."
Stone
fruits
(including
apricot,
cherry,
nectarine,
peach,
plum,
and
prune)
Directed
spray
application
Dormant
Ground
equipment
1.6
lb/
gal
EC
[62719
400]
2
lb/
gal
EC
[62719
395]
[62719
424]
1.5
lb/
A
NS
1.5
lb/
A
NS
Applications
may
be
made
in
a
minimum
of
40
gal
of
water/
A.
Applications
may
be
made
alone
or
as
a
tank
mix
with
other
herbicides.
The
use
of
any
treated
plants
for
feed
or
forage,
the
feeding
or
grazing
of
any
treated
area,
and
application
after
buds
start
to
swell
or
when
foliage
or
fruit
are
present
are
prohibited.
Taro
Broadcast
or
band
application
Preemergence
(within
one
week
after
transplanting)
Ground
equipment
1.6
lb/
gal
EC
[62719
400]
2
lb/
gal
EC
[62719
424]
0.5
lb/
A
NS
1.0
lb/
A
(all
uses)
6
(months)
Use
limited
to
HI.
Applications
may
be
made
in
a
minimum
of
15
gal
of
water/
A.
Directed
spray
application
Postemergence
Ground
equipment
1.6
lb/
gal
EC
[62719
400]
2
lb/
gal
EC
[62719
424]
0.25
lb/
A
NS
1.0
lb/
A
(all
uses)
0.5
lb/
A
(multiple
post
direct
applications)
0.5
lb/
A
(preemergent
uses)
6
(months)
Use
limited
to
dryland
taro
grown
in
HI.
Applications
may
be
made
in
a
minimum
of
20
gal
of
water/
A.
Site
Application
Type
Application
Timing
Application
Equipment
Formulation
Example
[EPA
Reg.
No.]
Maximum
Single
Application
Rate
(ai)
Maximum
No.
of
Applications
Per
Season
Maximum
Seasonal
Rate
(ai)
Preharvest
Interval
(Days)
Use
Limitations
1
88
Tree
nurseries
and
plantations,
right
of
ways,
irrigation
systems,
uncultivated
non
agricultural
land,
industrial
sites
Directed
spray
application
Postemergence
Ground
equipment
2
lb/
gal
EC
[62719
424]
2.0
lb/
A
NS
2.0
lb/
A
NA
Tree
nuts
(including
almond,
beech
nut,
Brazil
nut,
butternut,
cashew,
chestnut,
chinquapin,
filbert,
hickory
nut,
macadamia
nut,
pecan,
pistachio,
and
walnut)
Directed
spray
application
Dormant
Ground
equipment
1.6
lb/
gal
EC
[62719
400]
2
lb/
gal
EC
[62719
395]
[62719
424]
1.5
lb/
A
NS
1.5
lb/
A
NS
Applications
may
be
made
in
a
minimum
of
40
gal
of
water/
A.
Applications
may
be
made
alone
or
as
a
tank
mix
with
other
herbicides.
The
use
of
any
treated
plants
for
feed
or
forage,
the
feeding
or
grazing
of
any
treated
area,
and
application
after
buds
start
to
swell
or
when
foliage
or
fruit
are
present
are
prohibited.
Walnuts
(See
also
"Tree
nuts")
Directed
spray
application
Nondormant
Ground
equipment
1.6
lb/
gal
EC
[CA890012]
2
lb/
gal
EC
[CA960020]
1.5
lb/
A
NS
1.5
lb/
A
(nondormant
season)
7
Use
limited
to
CA.
Application
may
be
made
in
a
minimum
of
20
gal
of
water/
A
(minimum
of
10
gal/
A
for
certain
tank
mix
applications).
Application
may
be
made
alone
or
as
a
tank
mix
with
other
herbicides.
Chemigation
Nondormant
Flood
(basin)
irrigation,
low
volume
sprinkler
(microsprinkler)
or
drip
trickle
irrigation
2
lb/
gal
EC
[CA960020]
1.5
lb/
A
NS
1.5
lb/
A
(nondormant
season)
7
Use
limited
to
CA.
89
Appendix
B:
Data
Supporting
the
Reregistration
of
Oxyfluorfen
Data
Supporting
Guideline
Requirements
for
the
Reregistration
of
Oxyfluorfen
REQUIREMENT
USE
PATTERN
CITATION(
S)
New
Guideline
Number
Old
Guideline
Number
Description
PRODUCT
CHEMISTRY
830.1550
61
1
Product
Identity
and
Composition
All
44828901,
CSF
11/
17/
99
44720201,
CSF
12/
4/
98
830.1600
830.1200
61
2A
Start.
Mat.
&
Mnfg.
Process
All
44828901,
44720201
830.1670
61
2B
Formation
of
Impurities
All
44828901,
44720201
830.1700
62
1
Preliminary
Analysis
All
44828901,
44720201,
44720202
830.1750
62
2
Certification
of
limits
All
44828901,
CSF
11/
17/
99,
44712001,
44712002,
CSF
12/
4/
98
830.1800
62
3
Analytical
Method
All
44828901,
44720201,
44720202
830.6302
63
2
Color
All
44828902,
44720203
830.6303
63
3
Physical
State
All
44828902,
44720203
830.6304
63
4
Odor
All
44828902,
44720203
830.7050
None
UV/
Visable
Absorption
All
44828902,
44720203
830.7200
63
5
Melting
Point
All
44828902,
44720203
830.7300
63
7
Density
All
44828902,
44720203
830.7840
830.7860
63
8
Solubility
All
44828902,
44712004,
44712005
830.7950
63
9
Vapor
Pressure
All
44828902,
44712006
830.7550
63
11
Octanol/
Water
Partition
Coefficient
All
44828902,
44712007
ECOLOGICAL
EFFECTS
850.2100
71
1
Avian
Acute
Oral
Toxicity
All
92136102
850.2200
71
2A
Avian
Dietary
Toxicity
Quail
All
92136103
850.2200
71
2B
Avian
Dietary
Toxicity
Duck
All
92136104
850.2300
71
4A
Avian
Reproduction
Quail
All
Data
Gap
850.2300
71
4B
Avian
Reproduction
Duck
All
Data
Gap
850.1075
72
1A
Fish
Toxicity
Bluegill
All
42129801
850.1075
72
1C
Fish
Toxicity
Rainbow
Trout
All
42129802
850.1010
72
2A
Invertebrate
Toxicity
All
45271301
850.1075
72
3A
Estuarine/
Marine
Toxicity
Fish
All
41698801
850.1025
72
3B
Estuarine/
Marine
Toxicity
Mollusk
All
42378901
850.1035
850.1045
72
3C
Estuarine/
Marine
Toxicity
Shrimp
All
30970117
850.1400
72
4A
Fish
Early
Life
Stage
All
92136057
(99270),
Data
Gap
Data
Supporting
Guideline
Requirements
for
the
Reregistration
of
Oxyfluorfen
REQUIREMENT
USE
PATTERN
CITATION(
S)
New
Guideline
Number
Old
Guideline
Number
Description
90
850.1300
850.1350
72
4B
Estuarine/
Marine
Invertebrate
Life
Cycle
All
Data
Gap
850.1735
None
Fresh
Water
Whole
Sediment
Acute
Toxicity
All
Data
Gap
850.1740
None
Estruarine/
marine
Whole
Sediment
Acute
Toxicity
All
Data
Gap
850.1500
72
5
Life
Cycle
Fish
All
Reserved
850.4225
123
1A
Seed
Germ./
Seedling
Emergence
All
41644001,
Data
Gap
850.4250
123
1B
Vegetative
Vigor
All
41644001,
Data
Gap
850.4400
123
2
Aquatic
Plant
Growth
All
45271302
TOXICOLOGY
870.1100
81
1
Acute
Oral
Toxicity
Rat
All
44712010,
44828903
870.1200
81
2
Acute
Dermal
Toxicity
Rabbit/
Rat
All
44712011,
44828904
870.1300
81
3
Acute
Inhalation
Toxicity
Rat
All
44712012
870.2400
81
4
Primary
Eye
Irritation
Rabbit
All
44712013,
44828906
870.2500
81
5
Primary
Skin
Irritation
All
44712014,
44828905
870.2600
81
6
Dermal
Sensitization
All
44712015,
44814901
870.3100
82
1A
90
Day
Feeding
Rodent
All
44933101,
00117601,
92136011,
42142317,
00117603,
0017602,
92136012,
42142316
870.3200
82
2
21
Day
Dermal
Rabbit/
Rat
All
Data
Gap
870.3465
82
4
90
Day
Inhalation
Rat
All
Data
Gap
870.4100
83
1B
Chronic
Feeding
Toxicity
Non
Rodent
All
00078767,
92136062,
92136016
870.4200
83
2B
Oncogenicity
Mouse
All
00037939,
92136017
870.3700
83
3A
Developmental
Toxicity
Rat
All
44933103
870.3700
83
3B
Developmental
Toxicity
Rabbit
All
44933102,
00094052,
00094051,
92136018,
92136019
870.3800
83
4
2
Generation
Reproduction
Rat
All
42014901
870.4300
83
5
Combined
Chronic
Toxicity/
Carcinogenicity
All
00083445,
00135072,
92136061
870.5140
84
2A
Gene
Mutation
(Ames
Test)
All
00098421,
44942801,
44933104,
40992201,
00098420,
00098422,
44947205
870.5375
84
2B
Structural
Chromosomal
Aberration
All
00098419,
44933105,
44933106,
44947204,
44947203,
41873801,
00098418,
00109283,
00098423
None
84
4
Other
Genotoxic
Effects
All
44947201,
00098424
870.7485
85
1
General
Metabolism
All
42374201,
42652401
870.7600
85
2
Dermal
Penetration
All
42142306,
92136095
Data
Supporting
Guideline
Requirements
for
the
Reregistration
of
Oxyfluorfen
REQUIREMENT
USE
PATTERN
CITATION(
S)
New
Guideline
Number
Old
Guideline
Number
Description
91
OCCUPATIONAL/
RESIDENTIAL
EXPOSURE
875.2100
132
1A
Foliar
Residue
Dissipation
ABC
42098301
875.2400
133
3
Dermal
Passive
Dosimetry
Exposure
ABC
42098301
None
231
Estimation
of
Dermal
Exposure
at
Outdoor
Sites
ABC
44972201,
444598
01
ENVIRONMENTAL
FATE
835.2120
161
1
Hydrolysis
All
96882
835.2240
161
2
Photodegradation
Water
All
42142307,
42129101
835.2410
161
3
Photodegradation
Soil
All
41999901
835.4100
162
1
Aerobic
Soil
Metabolism
All
42142309
835.4200
162
2
Anaerobic
Soil
Metabolism
All
42142310
835.1240
163
1
Leaching/
Adsorption/
Desorption
All
94336,
42142311
835.6100
164
1
Terrestrial
Field
Dissipation
All
43840101
None
165
4
Bioaccumulation
in
Fish
All
96883
840.1200
202
1
Drift
Field
Evaluation
ABC
144894
RESIDUE
CHEMISTRY
None
171
2
Chemical
Identity
AB
Data
Gap
860.1300
171
4A
Nature
of
Residue
Plants
AB
00160143,
42865001,
42873301,
42913201,
92136027,
92136101,
92136114,
92136121
860.1300
171
4B
Nature
of
Residue
Livestock
AB
42634701
,
42670601,
43317701
860.1340
171
4C
Residue
Analytical
Method
Plants
AB
00149622,
40223201,
92136028,
92136029,
92136065,
44400202,
44400203
860.1340
171
4D
Residue
Analytical
Method
Animals
AB
00135077,
43307502
,
43307503,
43346401,
92136030,
92136060,
44400204,
44407801,
44506601
860.1380
171
4E
Storage
Stability
AB
43424201,
43424202,
43813201,
43859801
860.1480
171
4J
Magnitude
of
Residues
Meat
Milk/
Poultry/
Egg
AB
43152201,
43152202
Root
and
Tuber
Vegetables
Group
860.1500
171
4K
Crop
Field
Trials
(Horseradish)
AB
43973701
860.1500
171
4K
Crop
Field
Trials
(Taro
Corm)
AB
40940301
Leaves
of
Root
and
Tuber
Vegetables
Group
860.1500
171
4K
Crop
Field
Trials
(Taro
Foliage)
AB
40940301
Bulb
Vegetables
Group
860.1500
171
4K
Crop
Field
Trials
(Garlic)
AB
No
additional
data
required
Data
Supporting
Guideline
Requirements
for
the
Reregistration
of
Oxyfluorfen
REQUIREMENT
USE
PATTERN
CITATION(
S)
New
Guideline
Number
Old
Guideline
Number
Description
92
860.1500
171
4K
Crop
Field
Trials
(Onions,
dry
bulb)
AB
00126583,
43965501,
92136049,
92136083
Brassica
Leafy
Vegetables
Group
860.1500
171
4K
Crop
Field
Trials
(Broccoli)
AB
00148291,
40007203,
92136034,
92136070
860.1500
171
4K
Crop
Field
Trials
(Cabbage)
AB
00148291,
40007201,
43986301,
92136035,
92136071
860.1500
171
4K
Crop
Field
Trials
(Cauliflower)
AB
00148291,
40007202,
43986302,
92136036,
92136072
Legume
Vegetables
(Succulent
or
Dried)
Group
860.1500
171
4K
Crop
Field
Trials
(Chickpea)
AB
41622701
860.1500
171
4K
Crop
Field
Trials
(Soybean
seed
and
aspirated
grain
fractions)
AB
00125632,
00136873,
92136053,
92136086
Foliage
of
Legume
Vegetables
Group
860.1500
171
4K
Crop
Field
Trials
(Soybean
forage
and
hay)
AB
Data
Gap
Pome
Fruits
Group
860.1500
171
4K
Crop
Field
Trials
(All)
AB
00079475,
00141092,
40223206,
43794001,
44575901,
92136050,
92136051,
92136084
Stone
Fruits
Group
860.1500
171
4K
Crop
Field
Trials
(All)
AB
00036704,
00036705,
00036708,
00079475,
00110745,
00146340,
43794008,
44025401,
92136054,
92136087
Berries
Group
860.1500
171
4K
Crop
Field
Trials
(Blackberries)
AB
43424201
860.1500
171
4K
Crop
Field
Trials
(Raspberries)
AB
43424202
,
43424203
Tree
Nuts
Group
860.1500
171
4K
Crop
Field
Trials
(All)
AB
00036707,
00071290,
00071291,
00071292,
00071293,
00110745,
00141093,
40223206,
92136055,
92136088
860.1500
171
4K
Crop
Field
Trials
(Pistachios)
AB
00071290,
00071291,
00071292,
00071293,
92136056,
92136089
Cereal
Grains
Group
860.1500
171
4K
Crop
Field
Trials
(Corn,
field,
grain
and
aspirated
grain
fractions)
AB
00135077,
43944801,
92136038,
92136074
Forage,
Fodder,
Hay,
and
Straw
of
Cereal
Grains
Group
860.1500
171
4K
Crop
Field
Trials
(Corn,
field,
forage
and
fodder)
AB
00135077,
92136038,
92136074
Data
Supporting
Guideline
Requirements
for
the
Reregistration
of
Oxyfluorfen
REQUIREMENT
USE
PATTERN
CITATION(
S)
New
Guideline
Number
Old
Guideline
Number
Description
93
Miscellaneous
Commodities
860.1500
171
4K
Crop
Field
Trials
(Artichokes)
AB
00145973,
43794007,
92136031,
92136067
860.1500
171
4K
Crop
Field
Trials
(Avocado)
AB
00145972,
40223202,
43794002,
92136032,
92136068
860.1500
171
4K
Crop
Field
Trials
(Bananas)
AB
00102529,
92136033,
92136069,
Data
Gap
860.1500
171
4K
Crop
Field
Trials
(Cacao
beans)
AB
PP#
0E3898
860.1500
171
4K
Crop
Field
Trials
(Coffee)
AB
00102529,
92136037,
92136073
860.1500
171
4K
Crop
Field
Trials
(Cotton,
seed,
and
gin
byproducts)
AB
00071290,
00071291,
00071292,
00071293,
00110747,
92136039,
92136040,
92136075
860.1500
171
4K
Crop
Field
Trials
(Dates)
AB
00145972,
40223205,
92136041,
92136076
860.1500
171
4K
Crop
Field
Trials
(Fallow
land)
AB
40567001
860.1500
171
4K
Crop
Field
Trials
(Feijoa)
AB
PP#
9E3779
860.1500
171
4K
Crop
Field
Trials
(Figs)
AB
00079475,
43794003
,
92136042,
92136077
860.1500
171
4K
Crop
Field
Trials
(Grapes)
AB
00036703,
00110745,
00146340,
92136043,
92136078,
44385401,
44385402
860.1500
171
4K
Crop
Field
Trials
(Guavas)
AB
00158014,
92136044,
92136079
860.1500
171
4K
Crop
Field
Trials
(Kiwifruits)
AB
00145972,
40223203,
43794005,
92136045,
92136080
860.1500
171
4K
Crop
Field
Trials
(Mint,
tops)
AB
00071290,
00071291,
00071292,
00071293,
92136046,
92136047,
92136081
860.1500
171
4K
Crop
Field
Trials
(Olives)
AB
00145972,
40223204,
43794006,
92136048,
92136082
860.1500
171
4K
Crop
Field
Trials
(Papayas)
AB
40783201
860.1500
171
4K
Crop
Field
Trials
(Persimmons)
AB
PP#
9E3718
860.1500
171
4K
Crop
Field
Trials
(Pomegranates)
AB
00145972,
43794004
,
92136052,
92136085
860.1500
171
4K
Crop
Field
Trials
(Strawberries)
AB
IR
4
Project
PR
3443
Processed
Commodities
860.1520
171
4L
Processed
Food
(Apples)
AB
00141092,
92136051
860.1520
171
4L
Processed
Food
(Coffee)
AB
44172301
860.1520
171
4L
Processed
Food
(Corn,
field,
grain)
AB
43944801
860.1520
171
4L
Processed
Food
(Cottonseed)
AB
00071290,
00071291,
00071292,
00071293,
00110747,
92136040,
92136075
860.1520
171
4L
Processed
Food
(Figs)
AB
No
additional
data
required
Data
Supporting
Guideline
Requirements
for
the
Reregistration
of
Oxyfluorfen
REQUIREMENT
USE
PATTERN
CITATION(
S)
New
Guideline
Number
Old
Guideline
Number
Description
94
860.1520
171
4L
Processed
Food
(Grapes)
AB
No
additional
data
required
860.1520
171
4L
Processed
Food
(Mint)
AB
00071290,
00071291,
00071292,
00071293,
92136046,
92136047
860.1520
171
4L
Processed
Food
(Olives)
AB
No
additional
data
required
860.1520
171
4L
Processed
Food
(Plums)
AB
No
additional
data
required
860.1520
171
4L
Processed
Food
(Soybeans)
AB
43764901
860.1850
165
1
Rotational
Crops
(Confined)
AB
40567001
95
Appendix
C:
Technical
Support
Documents
Additional
documentation
in
support
of
this
RED
is
maintained
in
the
OPP
docket,
located
in
Room
119,
Crystal
Mall
#2,
1921
Jefferson
Davis
Highway,
Arlington,
VA.
It
is
open
Monday
through
Friday,
excluding
legal
holidays,
from
8:
30
am
to
4
pm.
The
docket
initially
contained
preliminary
risk
assessments
and
related
documents
as
of
August
10,
1998.
Sixty
days
later
the
first
public
comment
period
closed.
The
EPA
then
considered
comments,
revised
the
risk
assessment,
and
added
the
formal
"Response
to
Comments"
document
and
the
revised
risk
assessment
to
the
docket
on
June
16,
1999.
All
documents,
in
hard
copy
form,
may
be
viewed
in
the
OPP
docket
room
or
downloaded
or
viewed
via
the
Internet
at
the
following
site:
www.
epa.
gov/
pesticides/
op
These
documents
include:
HED
Documents:
1.
Revised
Human
Health
Risk
Assessment
for
Oxyfluorfen,
4
29
02,
Felicia
Fort,
OPP/
HED
2.
Second
Revised
Occupational
and
Residential
Risk
Assessment
for
Oxyfluorfen,
5
01
02,
Timothy
Dole,
OPP/
HED
3.
Report
of
the
HIARC
for
Oxyfluorfen,
Kit
Farwell,
OPP/
HED
4.
Toxicity
Chapter
for
Oxyfluorfen,
4
08
02,
Kit
Farwell,
OPP/
HED
5.
FQPA
Safety
Factor
Report,
4
30
01,
Kit
Farwell,
OPP/
HED
6.
Product
and
Residue
Chemistry
Chapter
for
Oxyfluorfen,
6
06
01,
Jose
Morales,
OPP/
HED
7.
Dietary
Risk
Assessment
for
Oxyfluorfen,
7
12
01,
Jose
Morales,
OPP/
HED
EFED
Documents:
1.
Water
Estimates
for
Oxyfluorfen,
8
30
01,
Amer
Al
Mudallal,
OPP/
EFED
2.
Revised
EFED
Risk
Assessment,
5
02
02,
Christine
Hartless,
OPP/
EFED
96
Appendix
D.
Citations
Considered
to
be
Part
of
the
Database
Supporting
the
Interim
Reregistration
Decision
(Bibliography)
GUIDE
TO
APPENDIX
D
1.
CONTENTS
OF
BIBLIOGRAPHY.
This
bibliography
contains
citations
of
all
studies
considered
relevant
by
EPA
in
arriving
at
the
positions
and
conclusions
stated
elsewhere
in
the
Reregistration
Eligibility
Document.
Primary
sources
for
studies
in
this
bibliography
have
been
the
body
of
data
submitted
to
EPA
and
its
predecessor
agencies
in
support
of
past
regulatory
decisions.
Selections
from
other
sources
including
the
published
literature,
in
those
instances
where
they
have
been
considered,
are
included.
2.
UNITS
OF
ENTRY.
The
unit
of
entry
in
this
bibliography
is
called
a
"study".
In
the
case
of
published
materials,
this
corresponds
closely
to
an
article.
In
the
case
of
unpublished
materials
submitted
to
the
Agency,
the
Agency
has
sought
to
identify
documents
at
a
level
parallel
to
the
published
article
from
within
the
typically
larger
volumes
in
which
they
were
submitted.
The
resulting
"studies"
generally
have
a
distinct
title
(or
at
least
a
single
subject),
can
stand
alone
for
purposes
of
review
and
can
be
described
with
a
conventional
bibliographic
citation.
The
Agency
has
also
attempted
to
unite
basic
documents
and
commentaries
upon
them,
treating
them
as
a
single
study.
3.
IDENTIFICATION
OF
ENTRIES.
The
entries
in
this
bibliography
are
sorted
numerically
by
Master
Record
Identifier,
or
"MRID"
number.
This
number
is
unique
to
the
citation,
and
should
be
used
whenever
a
specific
reference
is
required.
It
is
not
related
to
the
six
digit
"Accession
Number"
which
has
been
used
to
identify
volumes
of
submitted
studies
(see
paragraph
4(
d)(
4)
below
for
further
explanation).
In
a
few
cases,
entries
added
to
the
bibliography
late
in
the
review
may
be
preceded
by
a
nine
character
temporary
identifier.
These
entries
are
listed
after
all
MRID
entries.
This
temporary
identifying
number
is
also
to
be
used
whenever
specific
reference
is
needed.
4.
FORM
OF
ENTRY.
In
addition
to
the
Master
Record
Identifier
(MRID),
each
entry
consists
of
a
citation
containing
standard
elements
followed,
in
the
case
of
material
submitted
to
EPA,
by
a
description
of
the
earliest
known
submission.
Bibliographic
conventions
used
reflect
the
standard
of
the
American
National
Standards
Institute
(ANSI),
expanded
to
provide
for
certain
special
needs.
a
Author.
Whenever
the
author
could
confidently
be
identified,
the
Agency
has
chosen
to
show
a
personal
author.
When
no
individual
was
identified,
the
Agency
has
shown
an
identifiable
laboratory
or
testing
facility
as
the
author.
When
no
author
or
laboratory
could
be
identified,
the
Agency
has
shown
the
first
submitter
as
the
author.
b.
Document
date.
The
date
of
the
study
is
taken
directly
from
the
document.
When
the
date
is
followed
by
a
question
mark,
the
bibliographer
has
deduced
the
date
from
the
evidence
contained
in
the
document.
When
the
date
appears
as
(1999),
the
Agency
was
unable
to
determine
or
estimate
the
date
of
the
document.
97
c.
Title.
In
some
cases,
it
has
been
necessary
for
the
Agency
bibliographers
to
create
or
enhance
a
document
title.
Any
such
editorial
insertions
are
contained
between
square
brackets.
d.
Trailing
parentheses.
For
studies
submitted
to
the
Agency
in
the
past,
the
trailing
parentheses
include
(in
addition
to
any
self
explanatory
text)
the
following
elements
describing
the
earliest
known
submission:
(1)
Submission
date.
The
date
of
the
earliest
known
submission
appears
immediately
following
the
word
"received."
(2)
Administrative
number.
The
next
element
immediately
following
the
word
"under"
is
the
registration
number,
experimental
use
permit
number,
petition
number,
or
other
administrative
number
associated
with
the
earliest
known
submission.
(3)
Submitter.
The
third
element
is
the
submitter.
When
authorship
is
defaulted
to
the
submitter,
this
element
is
omitted.
(4)
Volume
Identification
(Accession
Numbers).
The
final
element
in
the
trailing
parentheses
identifies
the
EPA
accession
number
of
the
volume
in
which
the
original
submission
of
the
study
appears.
The
six
digit
accession
number
follows
the
symbol
"CDL,"
which
stands
for
"Company
Data
Library."
This
accession
number
is
in
turn
followed
by
an
alphabetic
suffix
which
shows
the
relative
position
of
the
study
within
the
volume.
BIBLIOGRAPHY
MRID
CITATION
______________________________________________________________________________
98
Toxicology
Chapter
Bibliography
00037939
Goldenthal,
E.
and
Wazeter,
F.
(1977).
RH
2915
Technical
Twenty
month
dietary
feeding
study
in
mice.
Final
reports.
International
Research
and
Development
Corporation,
Mattawan,
MI.
Laboratory
Project
Identification:
None
given.
Unpublished.
00071915
Cruzan,
G.(
1978)
RH
2915,
Twenty
day
repeat
percutaneous
toxicity
in
rabbits.
Toxicology
Department,
Rohm
and
Haas
Company,
Spring
House,
PA.
Protocol
No.
TD
77P
35.
February,
1978.
Unpublished.
00071916
Goldenthal,
E.
1978.
One
month
inhalation
toxicity
study
in
rats.
International
Research
and
Development
Corporation
Toxicology
Department
(address
not
given).
Study
No.
285
018,
June
21,
1978.
Unpublished.
00078767
Weatherholtz
W.
W.
(1981)
104
Week
Toxicity
Study
in
Dogs
RH
2915.
Hazleton
Laboratories
of
America,
Inc.
Project
No.
417
367,
April
9,
1981.
Unpublished.
00083445,
Auletta,
C.
and
W.
Rinehart
(1990)
Goal
®
technical
Herbicide
(RH
2915
00096872,
technical):
twenty
four
month
oral
toxicity/
carcinogenicity
study
in
rats.
92136061
Bio/
dynamics,
Inc.
Mettler
Rd.,
East
Millstone,
NJ
08873,
Laboratory
project
ID
75
1111A,
May
16,
1990.
(This
study
was
completed
in
1977.)
00094051
Hoberman,
A.
M.;
Christian,
M.
S.
(1981)
Goal
herbicide–
oral
rangefinding
study
in
pregnant
rabbits:
Argus
Project
018
006P;
Rohm
and
Haas
Company
Study
81P
86.
Prepared
by
Argus
Research
Laboratories,
Inc.,
submitted
by
Rohm
&
Haas
Co.,
Philadelphia,
Pa.;
CDL:
246694
B).
Unpublished.
00094052
Hoberman,
A.
M.,
M.
S.
Christian,
and
G.
D.
Christian
(1981)
Goal
herbicide
teratogenicity
study
in
rabbits.
Argus
Research
Laboratories,
Inc..
Argus
Project
018
006,
November
26,
1981.
Unpublished.
00098418
McCarthy,
K.
L.;
O'Neill,
P.
J.
(1982)
Goal
Technical
Cytogenetic
Study
in
Rats:
Report
No.
81R
261.
(Unpublished
study
received
Apr
8,
1982
under
707
145;
submitted
by
Rohm
&
Haas
Co.,
Philadelphia,
Pa.;
CDL:
247206
B)
00098419
Cifone,
M.
A.;
Fisher,
J.
(1982)
Mutagenicity
Evaluation
of
RH
2915,
Pure,
TD
81
308
in
the
Mouse
Lymphoma
Forward
Mutation
Assay:
LBI
Project
No.
20989;
Report
No.
81RC
165.
Final
rept.
(Unpublished
study,
including
letter
BIBLIOGRAPHY
MRID
CITATION
______________________________________________________________________________
99
dated
Mar
10,
1982
from
K.
L.
McCarthy
to
S.
S.
Burke,
received
Apr
8,
1982
under
707
145;
prepared
by
Litton
Bionetics,
Inc.,
submitted
by
Rohm
&
Haas
Co.;
Philadelphia,
Pa.;
CDL:
247206
C)
00098420
Scribner,
H.
E.;
Melly,
J.
G.;
O'Neill,
P.
J.;
et
al.
(1982)
Goal
RH
2915:
Microbial
Mutagen
Assay:
Report
No.
80R
247.
(Unpublished
study,
including
letter
dated
Mar
10,
1982
from
M.
F.
Cochran
and
S.
S.
Burke
to
C.
Swithenbank,
received
Apr
8,
1982
under
707
145;
submitted
by
Rohm
&
Haas
Co.,
Philadelphia,
Pa.;
CDL:
247206
D)
00098421
Scribner,
H.
E.;
Melly,
J.
G.;
O'Neill,
P.
J.;
et
al.
(1980)
Goal
Tech,
Purified:
Microbial
Mutagen
Assay:
Report
No.
81R
28.
(Unpublished
study,
including
letter
dated
Oct
28,
1981
from
M.
F.
Cochran
and
W.
T.
Lynch
to
C.
Swithenbank,
received
Apr
8,
1982
under
707
145;
submitted
by
Rohm
&
Haas
Co.,
Philadelphia,
Pa.;
CDL:
247206
E)
00098422
Scribner,
H.
E.;
Melly,
J.
G.;
Lohse,
K.;
et
al.
(1982)
Goal
(Polar
Fraction):
Microbial
Mutagen
Assay:
Report
No.
82R
80.
(Unpublished
study
received
Apr
8,
1982
under
707
145;
submitted
by
Rohm
&
Haas
Co.,
Philadelphia,
Pa.;
CDL:
247206
F)
00098423
Myhr,
B.
C.;
McKeon,
M.
(1982)
Evaluation
of
RH
2915
(TD
81
561,
Lot
No.
7530)
in
the
Primary
Rat
Hepatocyte:
Unscheduled
DNA
Synthesis
Assay:
LBI
Project
No.
20991;
No.
82RC
20.
Final
rept.
(Unpublished
study,
including
letter
dated
Mar
23,
1982
from
K.
L.
McCarthy
to
S.
S.
Burke,
received
Apr
8,
1982
under
707
145;
prepared
by
Litton
Bionetics,
Inc.,
submitted
by
Rohm
&
Haas
Co.,
Philadelphia,
Pa.;
CDL:
247206
G)
00098424
Myhr,
B.
C.;
McKeon,
M.
(1982)
Evaluation
of
Polar
Fraction
from
Lot
2
3985
(TD
81
562,
WJZ
1861)
in
the
Primary
Rat
Hepatocyte:
Unscheduled
DNA
Synthesis
Assay:
LBI
Project
No.
20991;
No.
82RC
21.
Final
rept.
(Unpublished
study,
including
letter
dated
Mar
23,
1982
from
K.
L.
McCarthy
to
S.
S.
Burke,
received
Apr
8,
1982
under
707
145;
prepared
by
Litton
Bionetics,
Inc.,
submitted
by
Rohm
&
Haas
Co.,
Philadelphia,
Pa.;
CDL:
247206
H)
00109283
Cifone,
M.;
Fisher,
J.
(1982)
Mutagenicity
Evaluation
of
RH
2915
Technical
in
the
Mouse
Lymphoma
Forward
Mutation
Assay:
LBI
Project
No.
20989;
Rohm
and
Haas
Report
No.
82RC
37.
Final
rept.
(Unpublished
study
received
Jul
22,
1982
under
707
145;
prepared
by
Litton
Bionetics,
Inc.,
submitted
by
Rohm
&
Haas
Co.,
Philadelphia,
PA;
CDL:
247900
A)
BIBLIOGRAPHY
MRID
CITATION
______________________________________________________________________________
100
00117601
Harris,
J.
C.
and
O'Hara,
G.
P.
(1982).
RH
2915
Three
month
dietary
toxicity
study
in
rats.
Rohm
and
Haas
Company,
Toxicology
Department,
Spring
House,
PA.
Report
No.
82R
62.
10/
26/
82.
Unpublished.
00117602
DiDonato,
L.
J.
and
O'Hara,
G.
P.
(1982).
Goal
Three
month
mouse
dietary
study.
Rohm
and
Haas
Company,
Toxicology
Department,
Spring
House,
PA.
Report
No.
82R
12.
10/
26/
82.
Unpublished.
00117603
Burke,
S.
S.
(review,
translated
from
Japanese,
original
author
not
provided,
1982).
Goal:
thirteen
week
subacute
toxicity
study
by
dietary
administration
in
rats.
Nomura
Research
Institute
(Japan).
Report
No.
81RC1008.
Unpublished.
00135072
Tornaben,
J.;
Barthel,
C.;
Brown,
W.
(1977)
A
Twenty
four
Month
Oral
Toxicity/
Carcinogenicity
Study
of
RH
2512
and
RH
2915
in
Rats:
Project
No.
75
1111.
(Unpublished
study
received
Mar
8,
1978
under
707
142;
prepared
in
cooperation
with
Research
Pathology
Services,
Inc.,
submitted
by
Rohm
&
Haas
Co.,
Philadelphia,
PA;
CDL:
096872
A)
40992201
Sames,
J.;
Frank,
J.
(1988)
Goal
Herbicide
(Technical):
Salmonella
typhimurium
Gene
Mutation
Assay:
Report
No.
88R
191.
Unpublished
study
prepared
by
Rohm
and
Haas
Co.
25
p.
41873801
Gudi,
R.
(1990)
Acute
Test
for
Chemical
Induction
of
Chromosome
Aberration
in
Mouse
Bone
Marrow
Cells
in
Vivo:
Lab
Project
Number
0158
1541:
90RC
006.
Unpublished
study
prepared
by
Sitek
Research
Laboratories.
49
p.
41806501
Solomon,
H.
M.
and
Romanello,
A.
S.
(1991)
Goal:
oral
(gavage)
developmental
toxicity
study
in
rats.
Rohm
and
Haas
Company,
Spring
House,
PA.
Study
Number:
90R
008.
Unpublished.
2/
15/
91.
Unpublished.
42014901
Solomon,
H.
M.,
W.
R.
Brown,
R.
E.
Swenson,
and
T.
L.
Thomas
(1991)
Goal
®
Technical
Herbicide:
Two
generation
reproduction
study
in
rats.
Rohm
and
Haas
Company,
Toxicology
Department,
Spring
House,
PA
19477.
Report
No.
90P007
August
26,
1991.
Unpublished.
42142316
Spinnler,
J.
F.
and
Towson,
A.
J.
(1990)
Goal®
technical
herbicide:
analytical
report
on
Goal®
content
in
mouse
feed.
5/
15/
90.
Unpublished.
(In
support
of
MRID
00117602,
Goal
Three
month
mouse
dietary
study,
Rohm
and
Haas
Company,
1982.)
BIBLIOGRAPHY
MRID
CITATION
______________________________________________________________________________
101
42142317
Spinnler,
J.
F.
and
Towson,
A.
J.
(1990).
Goal®
technical
herbicide:
analytical
report
on
Goal®
content
in
rat
feed.
Report
Supplement
No.
82R
062A.
5/
15/
90.
Unpublished.
(in
support
of
MRID
00117601,
Three
month
dietary
toxicity
study
in
rats.
Rohm
and
Haas
Company,
1982)
42142318
Spinnler,
J.;
Towson,
A.
(1990)
Goal
Technical
Herbicide:
Analytical
Report
on
Goal
Content
in
Rabbit
Gavage
Dose
Samples:
Supplement
to
MRID
94051:
Project
ID:
SC
81
0258:
81RC
142A.
Prepared
by
Rohm
and
Haas.
Unpublished.
42142319
Spinnler,
J.;
Towson,
A.
(1990)
Goal
Technical
Herbicide:
Analytical
Report
on
Goal
Content
in
Rabbit
Gavage
Dose
Samples:
Supplement
to
MRID
94052:
Project
ID:
SC
81
0259:
81RC
173A.
Prepared
and
submitted
by
Rohm
&
Haas.
Unpublished.
42374201
DiDonato,
L;
Hazelton,
G.
(1992)
Oxyfluorfen
(carbon
14)
(Goal
Herbicide):
Pharmacokinetic
Study
in
Rats:
Lab
Project
Number:
90P
193:
90R
193.
Unpublished
study
prepared
by
Rohm
&
Haas
Co.
133
p.
42652401
Zhang,
Q.
(1993)
Final
Report:
Pharmacokinetic
Study
in
Rats:
(carbon
14)
Oxyfluorfen
Supplemental
Report
A:
Metabolism
of
(carbon
14)
Oxyfluorfen
in
Rats:
Lab
Project
Number:
90R
193:
34
92
97.
Unpublished
study
prepared
by
Rohm
and
Haas
Co.
251
p.
44712010
Dreher,
D.
(1995)
AG
510:
Acute
Oral
Toxicity
(Limit)
Test
in
the
Rat:
Lab
Project
Number:
008.297.
Unpublished
study
prepared
by
Safepharm
Laboratories,
Ltd.
18
p.
44712011
Dreher,
D.
(1995)
AG
510:
Acute
Dermal
Toxicity
(Limit
Test)
in
the
Rat:
Lab
Project
Number:
008.298.
Unpublished
study
prepared
by
Safepharm
Laboratories,
Ltd.
19
p.
44712012
Blagden,
S.
(1995)
AG
510:
Acute
Inhalation
Toxicity
(Nose
Only)
in
the
Rat:
Lab
Project
Number:
008.299.
Unpublished
study
prepared
by
Safepharm
Laboratories,
Ltd.
34
p.
44712013
Dreher,
D.
(1995)
AG
510:
Acute
Eye
Irritation
Test
in
the
Rabbit:
Lab
Project
Number:
008.301.
Unpublished
study
prepared
by
Safepharm
Laboratories,
Ltd.
20
p.
BIBLIOGRAPHY
MRID
CITATION
______________________________________________________________________________
102
44712014
Dreher,
D.
(1995)
AG
510:
Acute
Dermal
Irritation
Test
in
the
Rabbit:
Lab
Project
Number:
008.300.
Unpublished
study
prepared
by
Safepharm
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Haas
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Haas
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3
Summary
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and
Related
MRIDs
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Goal
Herbicide
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Study
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Rohm
and
Haas
Report
81RC
173;
Project
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018
006.
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Week
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Phase
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Analysis
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Technical:
Lab
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PAI)
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n
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Water
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97.1.6856:
11742.0896.6112.705.
Unpublished
study
prepared
by
Springborn
Laboratories,
Inc.
42
p.
44712008
Wells,
D.
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Galigan
TGAI
Determination
of
Stability:
Final
Report:
Lab
Project
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97.1.6837:
11742.0896.
6113.863.
Unpublished
study
prepared
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Final
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156
p.
44712002
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Analysis
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5
Lots
of
Oxyfluorfen
Technical:
Lab
Project
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96
08:
9000849B.
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High
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Technical
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Lab
Project
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99
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Chemistry
Series
830
Group
B:
Physical
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Chemical
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High
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Lab
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APR
99
061:
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Haas
Co.,
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Haas
Company
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(Unpublished
study
received
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14,
1975
under
6G1690;
CDL:
094687
F)
00036705
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and
Haas
Company
(1975)
Analytical
Results
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14,
1975
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CDL:
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Oct
14,
1975
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Haas
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Detailed
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CDL:
094687
I)
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Haas
Company
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(Unpublished
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Haas
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707
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liquid
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4
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trifluoromethyl)
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unpublished
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707
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submitted
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&
Haas
Co.,
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Pa.;
CDL:
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Haas
Company
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Goal¼(
R)
:
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(Unpublished
study
received
Mar
20,
1981
under
707
145;
CDL:
099954
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&
Haas
Company
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Discussion:
Goal
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(Unpublished
study
received
Mar
20,
1981
under
707
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CDL:
099954
G)
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Haas
Company
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Goal¼(
R)
:
2E
Herbicide:
2
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1(
3
ethoxy
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nitrophenoxy)
4(
trifluoromethyl)
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070261
A)
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Haas
Co.
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óGoal
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Herbicide.
(Compilation;
unpublished
study
received
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21,
1982
under
707
145;
CDL:
070878
A)
00110745
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&
Haas
Co.
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Goal
2E
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...:
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142;
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098209
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78
21.
(Unpublished
study
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Oct
19,1978
under
707
EX
91;
submitted
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Rohm
&
Haas
Co.,
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PA;
CDL:
235349
A)
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Haas
Co.
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Residue
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(Compilation;
unpublished
study
received
Dec
23,
1975
under
707
EX
83;
CDL:
095071
A)
00126583
Rohm
&
Haas
Co.
(1983)
Goal
1.6E
Herbicide:
Residue
Chemistry:
Onion.
(Compilation;
unpublished
study
received
Mar
23,
1983
under
707
174;
CDL:
071493
A)
00135077
Rohm
&
Haas
Co.
(1978)
GOAL
2E
Herbicide
(Formerly
RH
2915):
Residue
Reports
and
Methods
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Chemistry
12.03).
(Compilation;
unpublished
study
received
Mar
8,
1978
under
707
142;
CDL:
096873
A;
096874)
00136873
Rohm
&
Haas
Co.
(1978)
Goal
2E
Herbicide
(Formerly
RH
2915)
...:
Residue
Reports
and
Methods:
Soybeans
and
Other
Food
Crops.
(Compilation;
unpublished
study
received
Mar
8,
1978
under
707
142;
CDL:
096875
A;
096876)
00141092
Rohm
&
Haas
Co.
(1984)
Residue
Chemistry:
Goal
1.
GE;
Goal
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Unpublished
compilation.
99
p.
00141093
Rohm
&
Haas
Co.
(1984)
Residue
Chemistry:
Goal
1.
GE.
Unpublished
compilation.
322
p.
00145972
Rohm
&
Haas
Co
(1984)
Residue
Chemistry:
Goal
1.
GE;
Goal
2E.
Unpublished
compilation.
127
p.
00145973
Rohm
&
Haas
Co.
(1984)
Residue
Chemistry:
Goal
1.6E.
Unpublished
compilation.
50
p.
00146340
Rohm
and
Haas
Co.
(1984)
Residue
Chemistry:
Goal
1.6E
and
Goal
2E
Herbicides
in
Fruits.
Unpublished
compilation.
216
p.
00148291
Interregional
Research
Project
No.
4
(1985)
Residue
of
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in
Broccoli,
Cabbage
&
Cauliflower¿.
Unpublished
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275
p.
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Herbicide:
Technical
Report
No.
3923
75
22.
Unpublished
study
prepared
by
Rohm
and
Haas
Company.
145
p.
00158014
Interregional
Research
Project
No.
4
(1984?)
The
Results
of
Tests
on
the
Amount
of
Oxyfluorfen
Residues
Remaining
in
or
on
Guava
Including
a
Description
of
the
Analytical
Method
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Unpublished
compilation.
99
p.
00160143
Zogorski,
W.;
Lafferty,
J.
(1986)
Translocation
Studies
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Mature
Apple
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from
Soil
Treated
with
Carbon
14
Goal
Herbicide:
Technical
Report
No.
310
86
06.
Unpublished
study
prepared
by
Rohm
and
Haas
Co.
275
p.
40007201
Baron,
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(1986)
Oxyfluorfen
Magnitude
of
Residue
on
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Additional
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Project
ID:
86
0076.
Unpublished
compilation
prepared
by
Interregional
Research
Project
No.
4
in
cooperation
with
Craven
Laboratories.
41
p.
40007202
Baron,
J.
(1986)
Oxyfluorfen
Magnitude
of
Residue
on
Cauliflower:
Additional
Data:
Project
ID:
86
0077.
Unpublished
compilation
prepared
by
Interregional
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Project
No.
4
in
cooperation
with
Craven
Laboratories.
54
p.
40007203
Baron,
J.
(1986)
Oxyfluorfen
Magnitude
of
Residue
on
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Additional
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Project
ID:
84
0089.
Unpublished
compilation
prepared
by
Interregional
Research
Project
40223201
Zogorski,
W.;
Craven,
D.
(1987)
An
Improved
Terminal
Residue
Analytical
Method
for
Determining
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Due
to
Oxyfluorfen,
Its
Major
Isomers,
and
Reduced
Metabolites
in
a
Variety
of
Crops
and
Soils:
Rohm
&
Haas
Technical
Report
No.:
31C
87
16.
Unpublished
study
prepared
by
Rohm
&
Haas
Co.
in
cooperation
with
Craven
Labs,
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66
p.
40223202
Zogorski,
W.
(1987)
Magnitude
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to
Oxyfluorfen
in
Avocado:
Rohm
&
Haas
Analytical
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No.
31A
87
29.
Unpublished
study
prepared
by
Rohm
&
Haas
Co.
in
cooperation
with
Craven
Labs,
Inc.
101
p.
40223204
Zogorski,
W.
(1987)
Magnitude
of
Residues
Due
to
Oxyfluorfen
in
Olives:
Rohm
&
Haas
Analytical
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No.
31A
87
28.
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prepared
by
Rohm
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Magnitude
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Haas
Analytical
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31A
87
30.
Unpublished
study
prepared
by
Rohm
&
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in
cooperation
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144
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40223206
Holmdal,
J.
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Harvest
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Storage
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Nut
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Pome
Fruit
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Residue
Data
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PP4F3115
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4F3119):
Rohm
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Haas
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85
59
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84
233.
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&
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6
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Carbon
14
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Rohm
and
Haas
Technical
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34C
88
11.
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study
prepared
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153
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Baron,
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(1988)
Oxyfluorfen
Magnitude
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Residue
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IR
4
PR
2062.
Unpublished
study
prepared
by
Univ.,
of
Hawaii,
Pesticide
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95
p.
40940301
Baron,
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(1988)
Oxyfluorfen:
Magnitude
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Residue
on
Taro
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IR
4
PR
No.
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Unpublished
study
prepared
by
University
of
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66
p.
41622701
Choban,
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(1989)
Oxyfluorfen:
Magnitude
of
Residue
on
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Lab
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IR/
4/
4041.
Unpublished
study
prepared
by
University
of
Hawaii.
82
p.
42634701
Kim
Kang,
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Metabolism
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14)
Oxyfluorfen
in
the
Laying
Hen
Analytical
Phase:
Identification
and
Quantitation
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Metabolites
in
Eggs
and
Tissues:
Lab
Project
Number:
XBL
92002:
RPT00111:
3107.13.
Unpublished
study
prepared
by
Xenobiotic
Labs
Inc.
299
p
42670601
Reibach,
P.
(1993)
Metabolism
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(carbon
14)
Oxyfluorfen
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Lactating
Dairy
Goats:
Lab
Project
Number:
34
93
4.
Unpublished
study
prepared
by
Rohm
and
Haas
Co.
and
ABC
Labs.,
Inc.
332
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42865001
Sun,
Y.
(1993)
Oxyfluorfen:
Nature
of
the
Residue
in
Tomato:
Lab
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Number:
34
93
49.
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study
prepared
by
Rohm
and
Haas
Company.
115
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Oxyfluorfen:
Nature
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the
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Stone
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Lab
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Number:
34
93
50.
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study
prepared
by
Rohm
and
Haas
Co.
129
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42913201
Sun,
Y.
(1993)
Oxyfluorfen:
Nature
of
the
Residue
in
Onion:
Lab
Project
Number:
34
93
65:
34P
92
35.
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study
prepared
by
Rohm
and
Haas
Co.
138
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Zhang,
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(1994)
Oxyfluorfen
(Goal
Herbicide)
Cow
Feeding
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Lactating
Diary
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Lab
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34P/
92/
61:
34/
93/
114.
Unpublished
study
prepared
by
Biodevelopment
Labs,
Inc.,
Centre
Analytical
Labs,
Inc.,
Bio
Life
Associates,
Ltd.,
and
Enviro
Bio
Tech
Ltd.
715
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Zhang,
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(1994)
Oxyfluorfen
(Goal
Herbicide)
Hen
Feeding
Study;
Magnitude
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in
Full
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Lab
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34P/
92/
62:
34/
93/
115.
Unpublished
study
prepared
by
Centre
Analytical
Labs,
Inc.,
Bio
Life
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Enviro
Bio
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587
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Zhang,
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Oxyfluorfen
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Meat
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Lab
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34
93
72.
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study
prepared
by
Rohm
and
Haas
Co.
and
Centre
Analytical
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Inc.
88
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Li,
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Analytical
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Lab
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34
93
46.
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prepared
by
Centre
Analytical
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33
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Kim
Kang,
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Supplemental
Analyses
of
Liver
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from
Dairy
Goats
Dosed
with
(carbon
14)
Oxyfluorfen:
Supplement
to
Rohm
and
Haas
Technical
Report
No.
34
93
4
(MRID
No.
42670601):
Lab
Project
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XBL
93101:
RPT00145:
34
94
79.
Unpublished
study
prepared
by
XenoBiotic
Labs,
Inc.
98
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Zhang,
Q.;
Stavinski,
S.
(1993)
Oxyfluorfen
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Milk
Residue
Analytical
Method:
Lab
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Number:
34
93
17:
TR
34
93
17.
Unpublished
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prepared
by
Rohm
and
Haas
Co.
33
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43424201
Biehn,
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Oxyfluorfen:
Magnitude
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Residue
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1988
1989
Trials:
Lab
Project
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3485:
88
OR
001:
89
OR
001.
Unpublished
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prepared
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State
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75
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Biehn,
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(1994)
Oxyfluorfen:
Magnitude
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Residue
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Raspberry,
1988
1989
Trials:
Lab
Project
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3486:
88
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002:
89
OR
002.
Unpublished
study
prepared
by
Oregon
State
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64
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43424203
Biehn,
W.
(1994)
Oxyfluorfen:
Magnitude
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Residue
on
Raspberry,
1992
Trial:
Lab
Project
Number:
A3486:
3486.92
RHR
08:
3486.92
WA37.
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by
Arthur
D.
Little,
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Washington
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263
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Holmdal,
J.
(1995)
Levels
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Residues
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Soybeans
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its
Processed
Components:
Oxyfluorfen
Residues
in
Soybean
Seed:
Lab
Project
Number:
34A
94
36:
RAR
92
0107:
94
0136.
Unpublished
study
prepared
by
Rohm
and
Haas
Co.
79
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Martin,
D.;
Zhang,
Q.
(1995)
Oxyfluorfen
Residues
in
Apples:
RAR
94
0129,
94
0130,
94
0152:
Lab
Project
Number:
94365:
34P
95
28A:
34
95
113.
Unpublished
study
prepared
by
McKenzie
Labs
and
Rohm
and
Haas
Co.
108
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43794002
Martin,
D.;
Zhang,
Q.
(1995)
Oxyfluorfen
Residues
in
Avocado:
RAR
94
0141:
Lab
Project
Number:
94366:
34P
95
29A:
34
95
115.
Unpublished
study
prepared
by
Centre
Analytical
Labs.
75
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43794003
Martin,
D.;
Zhang,
Q.
(1995)
Oxyfluorfen
Residues
in
Fig:
RAR
94
0142:
Lab
Project
Number:
94367:
34P
95
30A:
34
95
116.
Unpublished
study
prepared
by
Centre
Analytical
Labs.
74
p.
43794004
Martin,
D.;
Zhang,
Q.
(1995)
Oxyfluorfen
Residues
in
Pomegranate:
RAR
94
0143:
Lab
Project
Number:
94368:
34P
95
31A:
34
95
117.
Unpublished
study
prepared
by
Centre
Analytical
Labs.
72
p.
43794005
Martin,
D.;
Zhang,
Q.
(1995)
Oxyfluorfen
Residues
in
Kiwi:
RAR
94
0146:
Lab
Project
Number:
94369:
34P
95
32A:
34
95
118.
Unpublished
study
prepared
by
Centre
Analytical
Labs.
79
p.
43794006
Martin,
D.;
Zhang,
Q.
(1995)
Oxyfluorfen
Residues
in
Olive:
RAR
94
0172:
Lab
Project
Number:
94369:
34P
95
33A:
34
95
119.
Unpublished
study
prepared
by
Centre
Analytical
Labs.
78
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Martin,
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Zhang,
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Oxyfluorfen
Residues
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Artichoke:
RAR
94
0060,
94
0061:
Lab
Project
Number:
94374:
34P
95
36A:
34
95
120.
Unpublished
study
prepared
by
Centre
Analytical
Labs.
95
p.
43794008
Martin,
D.;
Zhang,
Q.
(1995)
Oxyfluorfen
Residues
in
Cherry:
RAR
94
0041,
94
0042:
Lab
Project
Number:
92302:
34P
95
37A:
34
95
121.
Unpublished
study
prepared
by
Centre
Analytical
Lab.
90
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43813201
Martin,
D.;
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Q.
(1995)
Storage
Stability
of
Cow
Muscle,
Cow
Liver,
Milk,
and
Egg
Treated
With
Goal
Herbicide:
Lab
Project
Number:
34
95
83:
TR
34
95
83:
RAR
93
0160.
Unpublished
study
prepared
by
Centre
Analytical
Labs
and
Biodevelopment
Labs,
Inc.
488
p.
43859801
Martin,
D.;
Zhang,
Q.
(1995)
Storage
Stability
Study:
Oxyfluorfen
in
Apples,
Alfalfa,
Almond
Nuts
and
Hulls,
Banana
Pulp,
Cabbage,
Cottonseeds,
Onions,
Oranges,
Peaches,
Strawberries,
Wheat
Grain,
and
Soil:
Lab
Project
Number:
34
95
82:
34P
92
09:
3107
04.
Unpublished
study
prepared
by
Biodevelopment
Labs,
Inc.
731
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43944801
Leppert,
B.
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Nature
and
Levels
of
Residues
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Field
Corn
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Its
Processed
Commodities
When
Goal
Herbicide
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Applied
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a
Post
Directed
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Lab
Project
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TR
34
95
175:
SARS
94
86:
94376.
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study
prepared
by
Stewart
Agricultural
Research
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221
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43965501
Biehn,
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Kunkel,
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Oxyfluorfen:
Magnitude
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Residue
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Onion:
Lab
Project
Number:
PR
5739:
05739:
5739.95
IDR06.
Unpublished
study
prepared
by
University
of
Idaho.
456
p.
43973701
Biehn,
W.;
Kunkel,
D.
(1996)
Oxyfluorfen:
Magnitude
of
Residue
on
Horseradish:
Lab
Project
Number:
05738:
PR
5738:
05738.94
IDR07.
Unpublished
study
prepared
by
Interregional
Research
Project
No.
4.
174
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43986301
Biehn,
W.;
Kunkel,
D.
(1996)
Oxyfluorfen:
Magnitude
of
Residue
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Cabbage:
Lab
Project
Number:
5105:
5105.91
RHR03:
5105.95
IDR05.
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study
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Labs,
Inc.
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637
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Oxyfluorfen:
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Residue
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Lab
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Number:
4013:
4013.92
RHE05:
4013.95
IDR10.
Unpublished
study
prepared
by
Biodevelopment
Labs,
Inc.
and
University
of
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384
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44025401
Martin,
D.;
Zhang,
Q.
(1996)
Oxyfluorfen
Residues
in
Peach:
RAR
94
0117,
95
0196:
Lab
Project
Number:
34
95
114:
34P
95
35A:
34P
95
51A.
Unpublished
study
prepared
by
Mckenzie
Labs.
and
Rohm
and
Haas
Co.
122
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Kunkel,
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(1996)
Oxyfluorfen:
Magnitude
of
Residue
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Coffee:
Lab
Project
Number:
5154:
5154.93
HSR01:
5154.93
HI05.
Unpublished
study
prepared
by
Hawaiian
Sugar
Planters
Assoc.
and
Univ.
of
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Manoa.
151
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44385401
Martin,
D.;
Zhang,
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Oxyfluorfen
Residues
in
Non
Dormant
Grape
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CA
Trials);
Supplemental
to
TR
34
95
104:
Lab
Project
Number:
92308:
92308A:
34P
95
65A.
Unpublished
study
prepared
by
Rohm
and
Haas
Company
and
Centre
Analytical
Labs,
Inc.
168
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44385402
Martin,
D.;
Zhang,
Q.
(1995)
Oxyfluorfen
Residues
in
Grape
RAR's
92
0069,
92
0070,
92
0080,
92
0132,
93
0012:
Lab
Project
Number:
92308:
92308A:
34P
95
65A.
Unpublished
study
prepared
by
Rohm
and
Haas
Company
and
Centre
Analytical
Labs,
Inc.
168
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44400202
Martin,
D.;
Zhang,
Q.
(1996)
Enforcement
Residue
Analytical
Method
for
GOAL
Herbicide
(Oxyfluorfen)
in
Crop
Commodities
with
GC/
MS
Confirmation:
Lab
Project
Number:
34P
95
92:
34
95
111:
TR
34
95
111.
Unpublished
study
prepared
by
Rohm
and
Haas
Co.,
Centre
Analytical
Labs.,
Inc.
and
McKenzie
Labs.
246
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44400203
Bruns,
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Independent
Laboratory
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Tolerance
Enforcement
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95
111)
for
GOAL
Herbicide
(Oxyfluorfen)
in
Crop
Commodities
Using
Peanut
Nutmeat
as
a
Sample:
Lab
Project
Number:
34P
96
56:
3107.14:
RHC09.
REP.
Unpublished
study
prepared
by
Enviro
Test
Labs.
168
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44400204
Zhang,
Q.;
Martin,
D.
(1997)
Oxyfluorfen
(Goal)
Meat,
Milk
and
Egg
Tolerance
Enforcement
Method
with
GLC/
MSD
Confirmation:
Lab
Project
Number:
34
95
110:
TR
34
95
110:
34
93
114.
Unpublished
study
prepared
by
Rohm
and
Haas
Co.,
Centre
Analytical
Labs.,
Inc.
and
XenoBiotic
Labs.,
Inc.
279
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{OPPTS
860.1340}
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MRID
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Zhang,
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Rohm
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Haas
Company
Partial
Response
to
EPA
CBTS
Review
of
Livestock
Feeding,
Ruminant
Metabolism
and
Analytical
Method
Data
Submitted
for
Oxyfluorfen
(Case
2490)
Reregistration
(MRID
#43307502,
43346401,
433075503,
and
43317701
DB
Barcode
D207134,
CBTS
#14321
and
14323):
Lab
Project
Number:
34
95
164:
TR
34
95
164:
TR
34
93
46.
Unpublished
study
prepared
by
Rohm
and
Haas
Company.
393
p.
{OPPTS
860.1300}
44506601
Szuter,
S.
(1995)
Independent
Laboratory
Method
Validation:
Oxyfluorfen
(Goal
Herbicide)
and
its
Isomers
Residue
Analytical
Method
(TR
34
95
110)
for
Meat,
Milk,
and
Egg:
Final
Report:
Lab
Project
Number:
TR
34
96
151:
TR
34P
95
85:
TR
34
93
17.
Unpublished
study
prepared
by
McKenzie
Laboratories,
Inc.
194
p.
44575901
Martin,
D.
(1998)
Magnitude
of
Oxyfluorfen
(GOAL
Herbicide)
Residue
in
Pears:
Lab
Project
Number:
96317:
34P
96
96A:
34
97
18.
Unpublished
study
prepared
by
Centre
Analytical
Laboratories,
Agri
Business
Group,
and
A.
C.
D.
S.
Research
Inc.
114
p.
{OPPTS
860.1500}
44712001
Wells,
D.
(1997)
Galigan
Characterization
of
the
Pure
Active
Ingredient
(AI):
Final
Report:
Lab
Project
Number:
97
1
6852:
11742.0896.6108.210.
Unpublished
study
prepared
by
Springborn
Laboratories,
Inc.
61
p.
44712002
Guzikevich,
G.
(1996)
Analysis
of
5
Lots
of
Oxyfluorfen
Technical:
Lab
Project
Number:
96
08:
9000849B.
Unpublished
study
prepared
by
Agan
Chemical
Manufacturers
Ltd.
120
p.
44712003
Wells,
D.
(1997)
Galigan
TGAI
Determining
the
Product
Chemistry:
Final
Report:
Lab
Project
Number:
97.1.6831:
11742.0896.6109.885.
Unpublished
study
prepared
by
Springborn
Laboratories,
Inc.
66
p.
44712004
Harley,
D.
(1997)
Galigan
TGAI
Determination
of
Solubility
in
Water
and
Six
Organic
Solvents:
Final
Report:
Lab
Project
Number:
97.1.6861:
11742.0896.6110.700.
Unpublished
study
prepared
by
Springborn
Laboratories,
Inc.
51
p.
44712005
Wells,
D.
(1998)
Galigan
(Oxyfluorfen)
TGAI
Determination
of
Water
Solubility:
Final
Report:
Lab
Project
Number:
98.4.7297:
11742.0997.6137.702.
Unpublished
study
prepared
by
Springborn
Laboratories,
Inc.
33
p.
BIBLIOGRAPHY
MRID
CITATION
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44712006
Wells,
D.
(1997)
Galigan
(Oxyfluorfen)
TGAI
Determination
of
Vapor
Pressure
Using
a
Gas
Saturation
Method:
Final
Report:
Lab
Project
Number:
97.1.6853:
11742.0896.6111.740.
Unpublished
study
prepared
by
Springborn
Laboratories,
Inc.
57
p.
44712007
Hartley,
D.
(1997)
Oxyfluorfen
(Galigan
PAI)
Determination
of
the
n
Octanol/
Water
Partition
Coefficient:
Final
Report:
Lab
Project
Number:
97.1.6856:
11742.0896.6112.705.
Unpublished
study
prepared
by
Springborn
Laboratories,
Inc.
42
p.
44712008
Wells,
D.
(1997)
Galigan
TGAI
Determination
of
Stability:
Final
Report:
Lab
Project
Number:
97.1.6837:
11742.0896.
6113.863.
Unpublished
study
prepared
by
Springborn
Laboratories,
Inc.
43
p.
44712009
Wells,
D.
(1998)
Galigan
(Oxyfluorfen)
TGAI
Determination
of
the
Storage
Stability
Under
Controlled
Conditions:
Final
Report:
Lab
Project
Number:
97.1.6862:
11742.0986.6114.865.
Unpublished
study
prepared
by
Springborn
Laboratories,
Inc.
50
p.
44720201
Guzikevich,
G.
(1997)
Oxyfluorfen
Technical
Product
Properties:
Lab
Project
Number:
97
05.
Unpublished
study
prepared
by
Agan
Chemical
Manufacturers,
LTD.
156
p.
44828901
Crawford,
J.
(1999)
Product
Chemistry
Series
830
Group
A:
Product
Identity,
Composition,
and
Analysis
for
Goal
High
Purity
Technical
Active
Ingredient:
Lab
Project
Number:
APR
99
060:
13
99
013TR.
Unpublished
study
prepared
by
Lancaster
Laboratories.
425
p.
44828902
Crawford,
J.
(1999)
Product
Chemistry
Series
830
Group
B:
Physical
and
Chemical
Characteristics
of
Goal
High
Purity
Technical
Active
Ingredient:
Lab
Project
Number:
APR
99
061:
RAS
133/
992443:
18862P.
Unpublished
study
prepared
by
Huntingdon
Life
Sciences
Ltd.
447
p.
92136031
Fisher,
J.
(1990)
Rohm
&
Haas
Company
Phase
3
Summary
of
MRID
00072716.
Magnitude
of
Goal
Residue
in
Artichoke.
Prepared
by
Rohm
and
Haas
Co.
9
p.
92136033
Fisher,
J.
(1990)
Rohm
&
Haas
Company
Phase
3
Summary
of
MRID
00070878.
Magnitude
of
Goal
Residue
in
Banana/
Plantain.
Prepared
by
Rohm
and
Haas
Co.
1
p.
BIBLIOGRAPHY
MRID
CITATION
______________________________________________________________________________
117
92136037
Fisher,
J.
(1990)
Rohm
&
Haas
Company
Phase
3
Summary
of
MRID
00070878.
Magnitude
of
Goal
Residue
in
Coffee.
Prepared
by
Rohm
and
Haas
Co.
11
p.
92136041
Fisher,
J.
(1990)
Rohm
&
Haas
Company
Phase
3
Summary
of
MRID
00072715
and
Related
MRIDs
40223205.
Magnitude
of
Goal
Residue
in
Dates.
Prepared
by
Hazleton
Laboratories
America,
Inc.
10
p.
92136042
Fisher,
J.
(1990)
Rohm
&
Haas
Company
Phase
3
Summary
of
MRID
00070261.
Magnitude
of
Goal
Residue
in
Figs.
Prepared
by
Rohm
and
Haas
Co.
9
p.
92136043
Fisher,
J.
(1990)
Rohm
&
Haas
Company
Phase
3
Summary
of
MRID
00098209
and
Related
MRIDs
00036701.
Magnitude
of
Residue
in
Grape.
Prepared
by
American
Cyanamid
Co.
10
p.
92136044
Fisher,
J.
(1990)
Rohm
&
Haas
Company
Phase
3
Summary
of
MRID
00002537.
IR
4
Magnitude
of
Goal
Residue
in
Guava.
Prepared
by
University
of
Hawaii.
10
p
92136046
Fisher,
J.
(1990)
Rohm
&
Haas
Company
Phase
3
Summary
of
MRID
00099954.
Magnitude
of
Goal
Residue
in
Mint
Hay.
Prepared
by
Rohm
and
Haas
Co.
13
p.
92136047
Fisher,
J.
(1990)
Rohm
&
Haas
Company
Phase
3
Summary
of
MRID
00099954.
Magnitude
of
Goal
Residue
in
Mint
Oil.
Prepared
by
Rohm
and
Haas
Co.
17
p.
92136049
Fisher,
J.
(1990)
Rohm
&
Haas
Company
Phase
3
Summary
of
MRID
00071493.
Magnitude
of
Goal
Residue
in
Onion.
Prepared
by
Applied
Biological
Sciences
Lab.
Inc.
10
p.
92136050
Fisher,
J.
(1990)
Rohm
&
Haas
Company
Phase
3
Summary
of
MRID
00070261
and
Related
MRIDs
00072714,
40223206.
Magnitude
of
Goal
Residue
in
Pomefruit.
Prepared
by
Rohm
and
Haas
Co.
10
p.
92136051
Fisher,
J.
(1990)
Rohm
&
Haas
Company
Phase
3
Summary
of
MRID
00072714.
Magnitude
of
Goal
Residue
in
Processed
Apples.
Prepared
by
Rohm
and
Haas
Co.
10
p.
BIBLIOGRAPHY
MRID
CITATION
______________________________________________________________________________
118
92136052
Fisher,
J.
(1990)
Rohm
&
Haas
Company
Phase
3
Summary
of
MRID
00072715.
Magnitude
of
Goal
Residue
in
Pomegranate.
Prepared
by
Hazleton
Laboratories
America,
Inc.
9
p.
92136053
Fisher,
J.
(1990)
Rohm
&
Haas
Company
Phase
3
Summary
of
MRID
00096876
and
Related
MRIDs
00095071.
Magnitude
of
Goal
Residue
in
Soybean.
Prepared
by
Chevron
Chemical
Co.
13
p.
92136054
Fisher,
J.
(1990)
Rohm
&
Haas
Company
Phase
3
Summary
of
MRID
00036705
and
Related
MRIDs
00098209,
00036704,
00036708,
00070261,
00146340.
Magnitude
of
Goal
Residue
in
Stone
Fruits.
Prepared
by
Rohm
and
Haas
Co.
14
p.
92136055
Fisher,
J.
(1990)
Rohm
&
Haas
Company
Phase
3
Summary
of
MRID
00099954
and
Related
MRIDs
00072717,
00036707,
00098209,
40223206,
00072718.
Magnitude
of
Goal
Residue
in
Treenuts.
Prepared
by
Rohm
and
Haas
Co.
14
p.
92136056
Fisher,
J.
(1990)
Rohm
&
Haas
Company
Phase
3
Summary
of
MRID
00099954.
Magnitude
of
Goal
Residue
in
Pistachios.
Prepared
by
Rohm
and
Haas
Co.
9
p.
92136057
Godfrey,
W.;
Longacre,
S.
(1990)
Rohm
&
Haas
Company
Phase
3
Summary
of
MRID
00099270.
Goal
Technical
Herbicide
(Oxyfluorfen)
Acute
Toxicity
to
Fathead
Minnow
Eggs
and
Fry:
Rohm
and
Haas
Report
80RC
015;
Project
BW
79
7
523.
Prepared
by
EG&
G
Bionomics.
15
p.
92136060
Carpenter,
C.
(1990)
Rohm
&
Haas
Company
Phase
3
Reformat
of
MRID
40478002
and
Related
MRIDs
40966201.
Revised
Product
Chemistry
Series
63
Physical
and
Chemical
Characteristics
for
RH
2915
(Oxyfluorfen):
Laboratory
Project
ID
CRC
90
029.
108
p.
92136067
Rohm
and
Haas
Co.
(1990)
Rohm
&
Haas
Company
Phase
3
Reformat
of
MRID
00072716.
Magnitude
of
Oxyfluorfen
Residues
in
Artichoke:
RAR
Code
Nos.
83
0090,
83
0185,
83
0186
and
83
0187.
Prepared
by
Rohm
and
Haas
Co.
57
p.
92136069
Rohm
and
Haas
Co.
(1990)
Rohm
&
Haas
Company
Phase
3
Reformat
of
MRID
00070878.
Magnitude
of
Oxyfluorfen
Residues
in
Banana/
Plantain.
Prepared
by
Rohm
and
Haas
Co.
116
p.
BIBLIOGRAPHY
MRID
CITATION
______________________________________________________________________________
119
92136070
Rohm
and
Haas
Co.
(1990)
Rohm
&
Haas
Company
Phase
3
Reformat
of
MRID
00073644
and
Related
MRIDs
40007203.
Magnitude
of
Oxyfluorfen
Residues
in
Broccoli.
Prepared
by
Cannon
Laboratories,
Inc.
157
p.
92136072
Rohm
and
Haas
Co.
(1990)
Rohm
&
Haas
Company
Phase
3
Reformat
of
MRID
00073644
and
Related
MRIDs
40007202.
Magnitude
of
Oxyfluorfen
Residues
in
Cauliflower.
Prepared
by
Cannon
Laboratories,
Inc.
117
p.
92136073
Rohm
and
Haas
Co.
(1990)
Rohm
&
Haas
Company
Phase
3
Reformat
of
MRID
00070878.
Magnitude
of
Oxyfluorfen
Residues
in
Coffee.
Prepared
by
Rohm
and
Haas
Co.
191
p.
92136074
Rohm
and
Haas
Co.
(1990)
Rohm
&
Haas
Company
Phase
3
Reformat
of
MRID
00096874.
Magnitude
of
Oxyfluorfen
Residues
in
Corn.
Prepared
by
Rohm
and
Haas
Co.
269
p.
92136075
Rohm
and
Haas
Co.
(1990)
Rohm
&
Haas
Company
Phase
3
Reformat
of
MRID
00110747
and
Related
MRIDs
00099954.
Magnitude
of
Oxyfluorfen
Residues
in
Cottonseed
and
Cottonseed
Oil.
Prepared
by
Rohm
and
Haas
Co.
146
p.
92136076
Rohm
and
Haas
Co.
(1990)
Rohm
&
Haas
Company
Phase
3
Reformat
of
MRID
00072715
and
Related
MRIDs
40223205.
Magnitude
of
Oxyfluorfen
Residues
in
Dates.
Prepared
by
Hazleton
Laboratories,
Inc.
176
p.
92136077
Rohm
and
Haas
Co.
(1990)
Rohm
&
Haas
Company
Phase
3
Reformat
of
MRID
00070261.
Magnitude
of
Oxyfluorfen
Residues
in
Figs:
RAR
Code
Nos.
80
0229,
80
0230
and
80
0231.
Prepared
by
Rohm
and
Haas
Co.
49
p.
92136078
Rohm
and
Haas
Co.
(1990)
Rohm
&
Haas
Company
Phase
3
Reformat
of
MRID
00098209
and
Related
MRIDs
00036701,
00146340.
Magnitude
of
Oxyfluorfen
Residues
in
Grape.
Prepared
by
American
Cyanamid
Co.
175
p.
92136079
Nishimoto,
R.
(1990)
Rohm
&
Haas
Company
Phase
3
Reformat
of
MRID
00002537.
Magnitude
of
Oxyfluorfen
Residues
in
Guava.
Prepared
by
University
of
HawaiI.
79
p.
92136081
Rohm
and
Haas
Co.
(1990)
Rohm
&
Haas
Company
Phase
3
Reformat
of
MRID
00099954.
Magnitude
of
Oxyfluorfen
Residues
in
Mint
Hay
and
Oil.
Prepared
by
Rohm
and
Haas
Co.
100
p.
92136082
Rohm
and
Haas
Co.
(1990)
Rohm
&
Haas
Company
Phase
3
Reformat
of
MRID
00072715
and
Related
MRIDs
40223204.
Magnitude
of
Oxyfluorfen
Residues
in
Olives.
Prepared
by
Hazleton
Laboratories,
inc.
146
p.
BIBLIOGRAPHY
MRID
CITATION
______________________________________________________________________________
120
92136083
Rohm
and
Haas
Co.
(1990)
Rohm
&
Haas
Company
Phase
3
Reformat
of
MRID
00071493.
Magnitude
of
Oxyfluorfen
Residues
in
Onion.
Prepared
by
Applied
Biological
Sciences
Lab,
Inc.
261
p.
92136084
Rohm
and
Haas
Co.
(1990)
Rohm
&
Haas
Company
Phase
3
Reformat
of
MRID
00070261
and
Related
MRIDs
00072714,
40223206.
Magnitude
of
Oxyfluorfen
Residues
in
Pome
Fruit
and
Pome
Fruit
Byproducts.
Prepared
by
Rohm
and
Haas
Co.
310
p.
92136085
Rohm
and
Haas
Co.
(1990)
Rohm
&
Haas
Company
Phase
3
Reformat
of
MRID
00072715.
Magnitude
of
Oxyfluorfen
Residues
in
Pomegranate:
RAR
Code
Nos.
82
0413
and
82
0433.
Prepared
by
Hazleton
Laboratories,
Inc.
40
p.
92136086
Rohm
and
Haas
Co.
(1990)
Rohm
&
Haas
Company
Phase
3
Reformat
of
MRID
00096876
and
Related
MRIDs
00095071.
Magnitude
of
Oxyfluorfen
Residues
in
Soybean
and
Soybean
Oil.
Prepared
by
Chevron
Chemical
Co.
769
p.
92136087
Rohm
and
Haas
Co.
(1990)
Rohm
&
Haas
Company
Phase
3
Reformat
of
MRID
00036705
and
Related
MRIDs
00036704,
00036708,
00098209,
00070261,
00146340.
Magnitude
od
Oxyfluorfen
Residues
in
Stone
Fruit.
Prepared
by
Rohm
and
Haas
Co.
559
p.
92136088
Rohm
and
Hass
Co.
(1990)
Rohm
&
Haas
Company
Phase
3
Reformat
of
MRID
00099954
and
Related
MRIDs
00072718,
00072717,
00036707,
00098209,
40223206.
Magnitude
of
Oxyfluorfen
Residues
in
Treenuts.
Prepared
by
Rohm
and
Haas
Co.
436
p.
92136089
Rohm
and
Haas
Co.
(1990)
Rohm
&
Haas
Company
Phase
3
Reformat
of
MRID
00099954.
Magnitude
of
Oxyfluorfen
Residues
in
Pistachio:
RAR
Code
Nos.
78
0413,
78
0414
and
78
0416.
Prepared
by
Rohm
and
Haas
Co.
32
p.
92136101
Reibach,
P.
(1990)
Rohm
&
Haas
Company
Phase
3
Summary
of
MRID
92136114.
Carbon
14
Oxyfluorfen
Metabolism
by
Alfalfa
under
Field
Conditions:
Rohm
and
Haas
Technical
Report
No.
34
90
27.
Prepared
by
Rohm
and
Haas
Co.
44
p.
BIBLIOGRAPHY
MRID
CITATION
______________________________________________________________________________
121
Occupational
Exposure
Chapter
References
42098301
Massey,
J.
(1990)
Rohm
and
Haas
Response
to
the
Oxyfluorfen
Reregistration
Phase
4
Data
Call
In:
Persistence
of
Dislodgeable
Residues
Under
Tree
Nursery
Conditions.
Unpublished
study
prepared
by
Rohm
and
Haas.
10
p.
44459801
Merricks,
D.
(1997)
Carbaryl
Mixer/
Loader/
Applicator
Exposure
Study
During
Application
of
RP
2
Liquid
(21%),
Sevin
Ready
to
Use
Insect
Spray
or
Sevin
10
Dust
to
Home
Garden
Vegetables:
Lab
Project
Number:
1519:
10564:
ML97
0676
RHP.
Unpublished
study
prepared
by
Agrisearch
Inc.,
Rhone
Poulenc
Ag
Co.
and
Morse
Labs.,
Inc.
358
p.
44972201
Klonne,
D.
(1999)
Integrated
Report
for
Evaluation
of
PotentialExposures
to
Homeowners
and
Professional
Lawn
Care
Operators
Mixing,
Loading,
and
Applying
Granular
and
Liquid
Pesticides
to
Residential
Lawns:
Lab
Project
Number:
OMAOO5:
OMAOO1:
OMAOO2.
Unpublished
study
prepared
by
Ricerca,
Inc.,
and
Morse
Laboratories.
2213
p.
Revised
Oxyfluorfen
(Goal)
Quantitative
Risk
Assessment
(Q1*)
Based
on
CD
1
Male
Mouse
Dietary
Study
with
3/
4's
Interspecies
Scaling
Factor;
Author
Lori
L.
Brunsman,
SAB/
HED/
OPP
(09/
24/
98)
Oxyfluorfen
Report
of
Food
Quality
Protection
Act
Safety
Factor
Committee
;
Author:
Brenda
Tarplee,
(Hed
Document
#014554
of
04/
30/
01)
Oxyfluorfen
Hazard
Identification
And
Review
Committee
Report;
Author:
Kit
Farwell,
DVM,
RRB1/
HED/
OPP;
(HED
Document
#0145549
of
04/
23/
01)
Review
of
Oxyfluorfen
Incident
Reports;
Authors:
Jerome
Blondell,
PhD,
and
Monica
Spann,
MPH,
CEB1/
HED/
OPP;
(HED
Document
#276054
of
07/
03/
01)
Oxyfluorfen
Use
Closure
Memo;
Author:
Deanna
Scher,
Chemical
Review
Manager
for
oxyfluorfen,
SRRD/
OPP;
Memo
directed
to
Oxyfluorfen
Team
(7/
01/
99).
Draft
Standard
Operating
Procedures
for
Residential
Exposure
Assessments.
U.
S.
EPA.
February
10,
1998.
BIBLIOGRAPHY
MRID
CITATION
______________________________________________________________________________
122
HED
Science
Advisory
Council
for
Exposure,
Policy
003.1,
"Agricultural
Default
Transfer
Coefficients"
Health
Effect
Division,
Office
of
Pesticide
Programs.
August,
1998.
HED
Science
Advisory
Council
for
Exposure,
Policy.
007,
"Use
of
Values
from
the
PHED
Surrogate
Table
and
Chemical
Specific
Data."
Health
Effects
Division,
Office
of
Pesticide
Programs.
January,
1999.
HED
Science
Advisory
Council
for
Exposure,
Policy.
009,
"Standard
Values
for
Daily
Acres
Treated
in
Agriculture"
Health
Effects
Division,
Office
of
Pesticide
Programs.
July
2000.
PHED
Surrogate
Exposure
Guide,
V1.1.
Health
Effects
Division,
Office
of
Pesticide
Program.
August,
1998."
Application
of
Pesticides
to
Crops,
G.
A.
Matthews,
Imperial
College
Press,
1999
USDA
Crop
Profiles
"Chemical
Mowing
with
Post
Emergent
Herbicides
in
Fraser
Fir
Christmas
Trees",
North
Carolina
Cooperative
Extension
Service
"Weed
Management
in
Conifer
Seedbeds
and
Transplant
Beds",
HIL
449,
Joseph
C.
Neal,
NC
State
University,
1999
Growing
Christmas
Trees
in
North
Carolina,
North
Carolina
Cooperative
Extension
Service,
May
1997
"Exposure
of
Herbicide
Handlers
in
the
CALTRANS
Vegetation
Control
Program
1993
1994"
California
Environmental
Protection
Agency,
April
27,
1995.
A
Strategy
for
Assessing
and
Managing
Occupational
Exposures,
John
Mulhausen
and
Joseph
Damiano,
AIHA
Press,
2
nd
Edition,
1998.
Ecotoxicity
Chapter
References
41644001
Hoberg,
J.
(1990)
Goal
Technical:
Determination
of
Effects
on
Seed
Germination,
Seedling
Emergence
and
Vegetative
Vigor
of
Ten
Plant
Species:
Lab
Project
BIBLIOGRAPHY
MRID
CITATION
______________________________________________________________________________
123
Number:
34
90
58:
86
1289
6105
610:
90
7
3373.
Unpublished
study
prepared
by
Springborn
Laboratories
Inc.
289
p.
41698801
Graves,
W.
(1990)
Goal
Technical
Herbicide:
A
96
Hour
Static
Acute
Toxicity
Test
with
the
Sheepshead
Minnow
(Cyprinodon
variegatus)
Final
Report:
Lab
Project
Number:
129A
101;
90RC
0009.
Unpublished
study
prepared
by
Rohm
&
Haas
Co.
161
p.
42129801
Graves,
W.;
Smith,
G.
(1991)
Goal
Technical
Herbicide:
A
96
Hour
Static
Acute
Toxicity
Test
with
the
Bluegill
(Lepomis
macrochirus):
Final
Report:
Lab
Project
Number:
129A
103A:
90RC
0097.
Unpublished
study
prepared
by
Wildlife
International
Ltd.
85
p.
42129802
Graves,
W.;
Smith,
G.
(1991)
Goal
Technical
Herbicide:
A
96
Hour
Static
Acute
Toxicity
Test
with
the
Rainbow
Trout
(Oncorynchus
mykiss):
Final
Report:
Lab
Project
Number:
129A
102:
90RC
0098.
Unpublished
study
prepared
by
Wildlife
International
Ltd.
84
p.
42378901
Graves,
W.
(1992)
Goal
Technical
Herbicide:
A
96
Hour
Shell
Deposition
Test
with
the
Eastern
Oyster
(Crassostrea
virginica):
Final
Report:
Lab
Project
Number:
129A
111A:
91RC
0175.
Unpublished
study
prepared
by
Wildlife
Intl.
Ltd.
74
p.
45271301
Sutherland,
C.;
Kendall,
T.;
Krueger,
H.
(2000)
Goal
2XL
(P)
Herbicide:
A
48
Hour
Flow
Through
Acute
Toxicity
Test
with
the
Cladoceran
(Daphnia
magna):
Lab
Project
Number:
129A
174:
00RC
0020.
Unpublished
study
prepared
by
Wildlife
International,
Ltd.
71
p.
{OPPTS
850.1010}
45271302
Sutherland,
C.;
Kendall,
T.;
Krueger,
H.
(2000)
Goal
2XL
(P)
Herbicide:
A
96
Hour
Toxicity
Test
with
the
Freshwater
Alga
(Selenastrum
capricornutum):
Lab
Project
Number:
129A
176:
00RC
0021.
Unpublished
study
prepared
by
Wildlife
International,
Ltd.
84
p.
{OPPTS
850.5400}
92136057
Godfrey,
W.;
Longacre,
S.
(1990)
Rohm
&
Haas
Company
Phase
3
Summary
of
MRID
00099270.
Goal
Technical
Herbicide
(Oxyfluorfen)
Acute
Toxicity
to
Fathead
Minnow
Eggs
and
Fry:
Rohm
and
Haas
Report
80RC
015;
Project
BW
79
7
523.
Prepared
by
EG&
G
Bionomics.
15
p.
BIBLIOGRAPHY
MRID
CITATION
______________________________________________________________________________
124
92136090
Godfrey,
W.;
Longacre,
S.
(1990)
Rohm
&
Haas
Company
Phase
3
Summary
of
MRID
92136102.
Goal
Technical
Herbicide
(Oxyfluorfen)
21
Day
Acute
Oral
Toxicity
Study
in
Bobwhite
Quail:
Rohm
and
Haas
Report
86RC
077;
Project
BLAL
86
QD
76.
Prepared
by
Bio
Life
Associates,
Ltd.
14
p.
92136091
Godfrey,
W.;
Longacre,
S.
(1990)
Rohm
&
Haas
Company
Phase
3
Summary
of
MRID
92136103.
Goal
Technical
Herbicide
(Oxyfluorfen)
8
Day
Dietary
LC50
Study
in
Bobwhite
Quail:
Rohm
and
Haas
Report
86RC
075;
Project
BLAL
86
QC
74.
Prepared
by
Bio
Life
Associates,
Ltd.
14
p.
92136092
Godfrey,
W.;
Longacre,
S.
(1990)
Rohm
&
Haas
Company
Phase
3
Summary
of
MRID
92136104.
Goal
Technical
Herbicide
(Oxyfluorfen):
8
Day
Dietary
LC50
Study
in
Mallard
Ducklings:
Rohm
and
Haas
Report
86RC
076;
Project
BLAL
86
DC
75.
Prepared
by
Bio
Life
Associates,
Ltd.
15
p.
Environmental
Fate
Chapter
References
00094336
Root,
M.;
Taitel,
C.;
Doull,
J.
(1964)
Subacute
Oral
Toxicity
ofBayer
25141
to
Male
and
Female
Rats:
submitter
14243.
(Unpublished
study
received
June
22,
1965;
Feb
7,
1966
under
3125
EX
101;
prepared
by
Univ.
of
Chicago,
Dept.
of
Pharmacology,
submitted
by
Mobay
Chemical
Corp.,
Kansas
City,
Mo.;
CDL:
126969
C)
41999901
Reibach,
P.
(1991)
Carbon
14
Oxyfluorfen
Photolysis
On
Soil
Under
Natural
Sunlight:
Lab
Project
Number:
34
91
46.
Unpublished
study
prepared
by
Rohm
and
Haas
Co.,
and
PTRL
East.
309
p.
42129101
Reibach,
P.
(1991)
Aqueous
Photolysis
of
Carbon
14
Oxyfluorfen:
Lab
Project
Number:
34
91
47.
Unpublished
study
prepared
by
Rohm
and
Haas
Co.
and
Xenobiotics
Labs.
268
p.
42142307
Kesterson,
A.;
Lawrence,
B.;
King,
D.;
et
al.
(1989)
Aqueous
Photolysis
of
Carbon
14
Oxyfluorfen
(Nitrophenyl
Ring
labelled)
in
Natural
Sunlight:
RTRL
Project
No.
261;
Report
No.
1194.
Unpublished
study
prepared
by
Pharmacology
&
Toxicology
Research
Laboratory.
138
p.
42142310
Korsch,
B.;
Doran,
T.
(1988)
Anaerobic
Soil
Metabolism
of
Oxyfluorfen:
Project
No.
87
0093;
Doc.
No.
1668
87
0093
EF
001;
TR
34C
88
61.
Unpublished
study
prepared
by
Ricerca,
Inc.
116
p.
BIBLIOGRAPHY
MRID
CITATION
______________________________________________________________________________
125
42142311
Reibach,
P.
(1988)
Adsorption/
Desorption
of
Carbon
14
Oxyfluorfen
R&
H
Tech
Report
No.
34C
88
64;
Protocol
No.
34P
88
75.
Unpublished
study
prepared
by
Rohm
&
Haas
Co.
196
p.
43840101
Reibach,
P.
(1995)
Terrestrial
Field
Dissipation
of
Goal
Herbicide
at
Two
Sites
in
California:
Lab
Project
Number:
34
95
139:
002
105:
94345.
Unpublished
study
prepared
by
ABC
Labs,
Inc.
and
Centre
Analytical
Lab.
1416
p.
92136023
Reibach,
P.
(1990)
Rohm
&
Haas
Company
Phase
3
Summary
of
MRID
00096882.
Oxyfluorfen
Hydrolysis:
TR
No.
34H
77
30.
29
p.
92136026
Reibach,
P.
(1990)
Rohm
&
Haas
Company
Phase
3
Summary
of
MRID
00096883.
A
Residue
and
Metabolism
Study
of
Carbon
14
RH
2915
in
Bluegill
Sunfish:
TR
No.
34
23.
Prepared
by
Chevron
Chemical
Co.
31
p.
92136058
Holmdal,
J.
(1990)
Rohm
&
Haas
Company
Phase
3
Summary
of
MRID
00144894.
Oxyfluorfen
Spray
Drift
Field
Evaluation.
Prepared
by
Rohm
and
Haas
Co.
16
p.
126
127
Appendix
E.
Generic
Data
Call
In
See
the
following
table
for
a
list
of
generic
data
requirements.
Note
that
a
complete
Data
Call
In
(DCI),
with
all
pertinent
instructions,
is
being
sent
to
registrants
under
separate
cover.
128
129
Appendix
F.
Product
Specific
Data
Call
In
See
attached
table
for
a
list
of
product
specific
data
requirements.
Note
that
a
complete
Data
Call
In
(DCI),
with
all
pertinent
instructions,
is
being
sent
to
registrants
under
separate
cover.
130
131
Appendix
G:
EPA'S
Batching
of
Oxyfluorfen
Products
for
Meeting
Acute
Toxicity
Data
Requirements
for
Reregistration
In
an
effort
to
reduce
the
time,
resources
and
number
of
animals
needed
to
fulfill
the
acute
toxicity
data
requirements
for
reregistration
of
products
containing
Oxyfluorfen
as
the
active
ingredient,
the
Agency
has
batched
products
which
can
be
considered
similar
for
purposes
of
acute
toxicity.
Factors
considered
in
the
sorting
process
include
each
product's
active
and
inert
ingredients
(identity,
percent
composition
and
biological
activity),
type
of
formulation
(e.
g.,
emulsifiable
concentrate,
aerosol,
wettable
powder,
granular,
etc.),
and
labeling
(e.
g.,
signal
word,
use
classification,
precautionary
labeling,
etc.).
Note
that
the
Agency
is
not
describing
batched
products
as
"substantially
similar"
since
some
products
within
a
batch
may
not
be
considered
chemically
similar
or
have
identical
use
patterns.
Using
available
information,
batching
has
been
accomplished
by
the
process
described
in
the
preceding
paragraph.
Not
with
standing
the
batching
process,
the
Agency
reserves
the
right
to
require,
at
any
time,
acute
toxicity
data
for
an
individual
product
should
the
need
arise.
Registrants
of
products
within
a
batch
may
choose
to
cooperatively
generate,
submit
or
cite
a
single
battery
of
six
acute
toxicological
studies
to
represent
all
the
products
within
that
batch.
It
is
the
registrants'
option
to
participate
in
the
process
with
all
other
registrants,
only
some
of
the
other
registrants,
or
only
their
own
products
within
a
batch,
or
to
generate
all
the
required
acute
toxicological
studies
for
each
of
their
own
products.
If
a
registrant
chooses
to
generate
the
data
for
a
batch,
he/
she
must
use
one
of
the
products
within
the
batch
as
the
test
material.
If
a
registrant
chooses
to
rely
upon
previously
submitted
acute
toxicity
data,
he/
she
may
do
so
provided
that
the
data
base
is
complete
and
valid
by
today's
standards
(see
acceptance
criteria
attached),
the
formulation
tested
is
considered
by
EPA
to
be
similar
for
acute
toxicity,
and
the
formulation
has
not
been
significantly
altered
since
submission
and
acceptance
of
the
acute
toxicity
data.
Regardless
of
whether
new
data
is
generated
or
existing
data
is
referenced,
registrants
must
clearly
identify
the
test
material
by
EPA
Registration
Number.
If
more
than
one
confidential
statement
of
formula
(CSF)
exists
for
a
product,
the
registrant
must
indicate
the
formulation
actually
tested
by
identifying
the
corresponding
CSF.
In
deciding
how
to
meet
the
product
specific
data
requirements,
registrants
must
follow
the
directions
given
in
the
Data
Call
In
Notice
and
its
attachments
appended
to
the
RED.
The
DCI
Notice
contains
two
response
forms
which
are
to
be
completed
and
submitted
to
the
Agency
within
90
days
of
receipt.
The
first
form,
"Data
Call
In
Response,"
asks
whether
the
registrant
will
meet
the
data
requirements
for
each
product.
The
second
form,
"Requirements
Status
and
Registrant's
Response,"
lists
the
product
specific
data
required
for
each
product,
including
the
standard
six
acute
toxicity
tests.
A
registrant
who
wishes
to
participate
in
a
batch
must
decide
whether
he/
she
will
provide
the
data
or
depend
on
someone
else
to
do
so.
If
a
registrant
supplies
the
data
to
support
a
batch
of
products,
he/
she
must
select
one
of
the
following
options:
Developing
Data
(Option
1),
Submitting
an
Existing
Study
(Option
4),
Upgrading
an
Existing
132
Study
(Option
5)
or
Citing
an
Existing
Study
(Option
6).
If
a
registrant
depends
on
another's
data,
he/
she
must
choose
among:
Cost
Sharing
(Option
2),
Offers
to
Cost
Share
(Option
3)
or
Citing
an
Existing
Study
(Option
6).
If
a
registrant
does
not
want
to
participate
in
a
batch,
the
choices
are
Options
1,
4,
5
or
6.
However,
a
registrant
should
know
that
choosing
not
to
participate
in
a
batch
does
not
preclude
other
registrants
in
the
batch
from
citing
his/
her
studies
and
offering
to
cost
share
(Option
3)
those
studies.
Fourteen
products
were
found
which
contain
Oxyfluorfen
as
the
active
ingredient.
These
products
have
been
placed
into
four
batches
and
a
"No
Batch"
category
in
accordance
with
the
active
and
inert
ingredients
and
type
of
formulation.
Furthermore,
the
following
bridging
strategies
are
deemed
acceptable
for
this
chemical:
°
No
Batch:
Each
product
in
this
Batch
should
generate
their
own
data.
NOTE:
The
technical
acute
toxicity
values
included
in
this
document
are
for
informational
purposes
only.
The
data
supporting
these
values
may
or
may
not
meet
the
current
acceptance
criteria.
Batch
1
EPA
Reg.
No.
%
Active
Ingredient
11603
29
97.4
62719
399
99.0
Batch
2
EPA
Reg.
No.
%
Active
Ingredient
62719
395
23.5
62719
400
19.4
Batch
3
EPA
Reg.
No.
%
Active
Ingredient
62719
424
23.0
66222
28
22.2
Batch
4
EPA
Reg.
No.
%
Active
Ingredient
4
432
Oxyfluorfen:
0.25
Glyphosate:
0.25
239
2516
Oxyfluorfen:
0.25
Glyphosate:
0.25
133
No
Batch
EPA
Reg.
No.
%
Active
Ingredient
239
2622
Oxyfluorfen:
0.70
Imazapyr:
0.08
524
520
Oxyfluorfen:
2.50
Glyphosate:
40.00
538
172
Oxyfluorfen:
2.00
Pendimethalin:
1.00
48234
10
Oxyfluorfen:
2.00
Oxadiazon:
1.00
58185
27
Oxyfluorfen:
2.00
Oryzalin:
1.00
62719
447
41.00
134
Appendix
H.
List
of
Registrants
Sent
This
Data
Call
In
135
136
Appendix
I.
List
of
Available
Related
Documents
and
Electronically
Available
Forms
Pesticide
Registration
Forms
are
available
at
the
following
EPA
internet
site:
http://
www.
epa.
gov/
opprd001/
forms/
Pesticide
Registration
Forms
(These
forms
are
in
PDF
format
and
require
the
Acrobat
reader)
Instructions
1.
Print
out
and
complete
the
forms.
(Note:
Form
numbers
that
are
bolded
can
be
filled
out
on
your
computer
then
printed.)
2.
The
completed
form(
s)
should
be
submitted
in
hardcopy
in
accord
with
the
existing
policy.
3.
Mail
the
forms,
along
with
any
additional
documents
necessary
to
comply
with
EPA
regulations
covering
your
request,
to
the
address
below
for
the
Document
Processing
Desk.
DO
NOT
fax
or
e
mail
any
form
containing
'Confidential
Business
Information'
or
'Sensitive
Information.
'
If
you
have
any
problems
accessing
these
forms,
please
contact
Nicole
Williams
at
(703)
308
5551
or
by
e
mail
at
williams.
nicole@
epa.
gov.
The
following
Agency
Pesticide
Registration
Forms
are
currently
available
via
the
internet:
at
the
following
locations:
8570
1
Application
for
Pesticide
Registration/
Amendment
http://
www.
epa.
gov/
opprd001/
forms/
8570
1.
pdf
8570
4
Confidential
Statement
of
Formula
http://
www.
epa.
gov/
opprd001/
forms/
8570
4.
pdf
8570
5
Notice
of
Supplemental
Registration
of
Distribution
of
a
Registered
Pesticide
Product
http://
www.
epa.
gov/
opprd001/
forms/
8570
5.
pdf
8570
17
Application
for
an
Experimental
Use
Permit
http://
www.
epa.
gov/
opprd001/
forms/
8570
17.
pdf
8570
25
Application
for/
Notification
of
State
Registration
of
a
Pesticide
To
Meet
a
Special
Local
Need
http://
www.
epa.
gov/
opprd001/
forms/
8570
25.
pdf
8570
27
Formulator's
Exemption
Statement
http://
www.
epa.
gov/
opprd001/
forms/
8570
27.
pdf
137
8570
28
Certification
of
Compliance
with
Data
Gap
Procedures
http://
www.
epa.
gov/
opprd001/
forms/
8570
28.
pdf
8570
30
Pesticide
Registration
Maintenance
Fee
Filing
http://
www.
epa.
gov/
opprd001/
forms/
8570
30.
pdf
8570
32
Certification
of
Attempt
to
Enter
into
an
Agreement
with
other
Registrants
for
Development
of
Data
http://
www.
epa.
gov/
opprd001/
forms/
8570
32.
pdf
8570
34
Certification
with
Respect
to
Citations
of
Data
(PR
Notice
98
5)
http://
www.
epa.
gov/
opppmsd1/
PR_
Notices/
pr98
5.
pdf
8570
35
Data
Matrix
(PR
Notice
98
5)
http://
www.
epa.
gov/
opppmsd1/
PR_
Notices/
pr98
5.
pdf
8570
36
Summary
of
the
Physical/
Chemical
Properties
(PR
Notice
98
1)
http://
www.
epa.
gov/
opppmsd1/
PR_
Notices/
pr98
1.
pdf
8570
37
Self
Certification
Statement
for
the
Physical/
Chemical
Properties
(PR
Notice
98
1)
http://
www.
epa.
gov/
opppmsd1/
PR_
Notices/
pr98
1.
pdf
Pesticide
Registration
Kit
www.
epa.
gov/
pesticides/
registrationkit/
Dear
Registrant:
For
your
convenience,
we
have
assembled
an
online
registration
kit
which
contains
the
following
pertinent
forms
and
information
needed
to
register
a
pesticide
product
with
the
U.
S.
Environmental
Protection
Agency's
Office
of
Pesticide
Programs
(OPP):
1.
The
Federal
Insecticide,
Fungicide,
and
Rodenticide
Act
(FIFRA)
and
the
Federal
Food,
Drug
and
Cosmetic
Act
(FFDCA)
as
Amended
by
the
Food
Quality
Protection
Act
(FQPA)
of
1996.
2.
Pesticide
Registration
(PR)
Notices
a.
83
3
Label
Improvement
Program
Storage
and
Disposal
Statements
b.
84
1
Clarification
of
Label
Improvement
Program
c.
86
5
Standard
Format
for
Data
Submitted
under
FIFRA
d.
87
1
Label
Improvement
Program
for
Pesticides
Applied
through
Irrigation
Systems
(Chemigation)
e.
87
6
Inert
Ingredients
in
Pesticide
Products
Policy
Statement
f.
90
1
Inert
Ingredients
in
Pesticide
Products;
Revised
Policy
Statement
g.
95
2
Notifications,
Non
notifications,
and
Minor
Formulation
Amendments
h.
98
1
Self
Certification
of
Product
Chemistry
Data
with
Attachments
(This
document
is
in
PDF
format
and
requires
the
Acrobat
reader.)
138
Other
PR
Notices
can
be
found
at
http://
www.
epa.
gov/
opppmsd1/
PR_
Notices
3.
Pesticide
Product
Registration
Application
Forms
(These
forms
are
in
PDF
format
and
will
require
the
Acrobat
reader).
a.
EPA
Form
No.
8570
1,
Application
for
Pesticide
Registration/
Amendment
b.
EPA
Form
No.
8570
4,
Confidential
Statement
of
Formula
c.
EPA
Form
No.
8570
27,
Formulator's
Exemption
Statement
d.
EPA
Form
No.
8570
34,
Certification
with
Respect
to
Citations
of
Data
e.
EPA
Form
No.
8570
35,
Data
Matrix
4.
General
Pesticide
Information
(Some
of
these
forms
are
in
PDF
format
and
will
require
the
Acrobat
reader).
a.
Registration
Division
Personnel
Contact
List
B.
Biopesticides
and
Pollution
Prevention
Division
(BPPD)
Contacts
C.
Antimicrobials
Division
Organizational
Structure/
Contact
List
d.
53
F.
R.
15952,
Pesticide
Registration
Procedures;
Pesticide
Data
Requirements
(PDF
format)
e.
40
CFR
Part
156,
Labeling
Requirements
for
Pesticides
and
Devices
(PDF
format)
f.
40
CFR
Part
158,
Data
Requirements
for
Registration
(PDF
format)
g.
50
F.
R.
48833,
Disclosure
of
Reviews
of
Pesticide
Data
(November
27,
1985)
Before
submitting
your
application
for
registration,
you
may
wish
to
consult
some
additional
sources
of
information.
These
include:
1.
The
Office
of
Pesticide
Programs'
website.
2.
The
booklet
"General
Information
on
Applying
for
Registration
of
Pesticides
in
the
United
States",
PB92
221811,
available
through
the
National
Technical
Information
Service
(NTIS)
at
the
following
address:
National
Technical
Information
Service
(NTIS)
5285
Port
Royal
Road
Springfield,
VA
22161
The
telephone
number
for
NTIS
is
(703)
605
6000.
3.
The
National
Pesticide
Information
Retrieval
System
(NPIRS)
of
Purdue
University's
Center
for
Environmental
and
Regulatory
Information
Systems.
This
139
service
does
charge
a
fee
for
subscriptions
and
custom
searches.
You
can
contact
NPIRS
by
telephone
at
(765)
494
6614
or
through
their
website.
4.
The
National
Pesticide
Information
Center
(NPIC)
can
provide
information
on
active
ingredients,
uses,
toxicology,
and
chemistry
of
pesticides.
You
can
contact
NPIC
by
telephone
at
(800)
858
7378
or
through
their
website:
http://
npic.
orst.
edu..
The
Agency
will
return
a
notice
of
receipt
of
an
application
for
registration
or
amended
registration,
experimental
use
permit,
or
amendment
to
a
petition
if
the
applicant
or
petitioner
encloses
with
his
submission
a
stamped,
self
addressed
postcard.
The
postcard
must
contain
the
following
entries
to
be
completed
by
OPP:
a.
Date
of
receipt;
b.
EPA
identifying
number;
and
c.
Product
Manager
assignment.
Other
identifying
information
may
be
included
by
the
applicant
to
link
the
acknowledgment
of
receipt
to
the
specific
application
submitted.
EPA
will
stamp
the
date
of
receipt
and
provide
the
EPA
identifying
file
symbol
or
petition
number
for
the
new
submission.
The
identifying
number
should
be
used
whenever
you
contact
the
Agency
concerning
an
application
for
registration,
experimental
use
permit,
or
tolerance
petition.
To
assist
us
in
ensuring
that
all
data
you
have
submitted
for
the
chemical
are
properly
coded
and
assigned
to
your
company,
please
include
a
list
of
all
synonyms,
common
and
trade
names,
company
experimental
codes,
and
other
names
which
identify
the
chemical
(including
"blind"
codes
used
when
a
sample
was
submitted
for
testing
by
commercial
or
academic
facilities).
Please
provide
a
chemical
abstract
system
(CAS)
number
if
one
has
been
assigned.
Documents
Associated
with
this
RED
The
following
documents
are
part
of
the
Administrative
Record
for
this
RED
document
and
may
be
included
in
the
EPA's
Office
of
Pesticide
Programs
Public
Docket.
Copies
of
these
documents
are
not
available
electronically,
but
may
be
obtained
by
contacting
the
person
listed
on
the
respective
Chemical
Status
Sheet.
1.
Health
Effects
Division
and
Environmental
Fate
and
Effects
Division
Science
Chapters,
which
include
the
complete
risk
assessments
and
supporting
documents.
2.
Detailed
Label
Usage
Information
System
(LUIS)
Report.
| epa | 2024-06-07T20:31:43.861008 | regulations | {
"license": "Public Domain",
"url": "https://downloads.regulations.gov/EPA-HQ-OPP-2002-0255-0003/content.txt"
} |
EPA-HQ-OPP-2002-0257-0001 | Notice | "2002-09-27T04:00:00" | Nominations for FIFRA Scientific Advisory Panel; Request for Comments | <PRE>
[Federal
Register:
September
27,
2002
(Volume
67,
Number
188)]
[Notices]
[Page
61094
61097]
From
the
Federal
Register
Online
via
GPO
Access
[wais.
access.
gpo.
gov]
[DOCID:
fr27se02
93]
ENVIRONMENTAL
PROTECTION
AGENCY
[OPP
2002
0257;
FRL
7275
4]
Nominations
for
FIFRA
Scientific
Advisory
Panel;
Request
for
Comments
AGENCY:
Environmental
Protection
Agency
(EPA).
ACTION:
Notice.
SUMMARY:
This
notice
provides
the
names,
addresses,
professional
affiliations,
and
selected
biographical
data
of
persons
nominated
to
serve
on
the
Federal
Insecticide,
Fungicide,
and
Rodenticide
Act,
Scientific
Advisory
Panel
(FIFRA)/(
SAP)
established
under
section
25(
d)
of
the
FIFRA.
The
Panel
was
created
on
November
28,
1975,
and
made
a
statutory
Panel
by
amendment
to
FIFRA,
dated
October
25,
1988.
Public
comment
on
the
nominations
is
invited,
as
these
comments
will
be
used
to
assist
the
Agency
in
selecting
three
new
chartered
Panel
members.
[[
Page
61095]]
DATES:
Comments,
identified
by
docket
ID
number
OPP
2002
0257,
must
be
received
on
or
before
October
28,
2002.
ADDRESSES:
Comments
may
be
submitted
by
mail,
electronically,
or
in
person.
Please
follow
the
detailed
instructions
for
each
method
as
provided
in
Unit
I.
of
the
SUPPLEMENTARY
INFORMATION.
To
ensure
proper
receipt
by
EPA,
it
is
imperative
that
you
identify
docket
ID
number
OPP
2002
0257
in
the
subject
line
on
the
first
page
of
your
response.
FOR
FURTHER
INFORMATION
CONTACT:
By
mail:
Steven
Knott,
Office
of
Science
Coordination
and
Policy
(7201M),
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW,
Washington,
DC
20460;
telephone
number:
(202)
564
8450;
fax
number
(202)
564
8382;
e
mail
address:
<A
HREF="
mailto:
knott.
steven@
epa.
gov">
knott.
steven@
epa.
gov</
A>.
SUPPLEMENTARY
INFORMATION:
I.
General
Information
A.
Does
This
Action
Apply
to
Me?
This
action
is
directed
to
the
public
in
general.
Since
other
entities
may
also
be
interested,
the
Agency
has
not
attempted
to
describe
all
the
specific
entities
that
may
be
affected
by
this
action.
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
Additional
Information,
Including
Copies
of
This
Document
and
Other
Related
Documents?
1.
Electronically.
You
may
obtain
electronic
copies
of
this
document,
and
certain
other
related
documents
that
might
be
available
electronically,
from
the
EPA
Internet
Home
Page
at
<A
HREF="
http://
frwebgate.
acc
ess.
gpo.
gov/
cgi
bin/
leaving.
cgi?
from=
leavingFR.
html&
log=
linklog&
to=
http://
www.
ep
a.
gov/">
http://
www.
epa.
gov/</
A>.
To
access
this
document,
on
the
Home
Page
select
``
Laws
and
Regulations,
''
``
Regulations
and
Proposed
Rules,
''
and
then
look
up
the
entry
for
this
document
under
the
``
Federal
Register
Environmental
Documents.
''
You
can
also
go
directly
to
the
Federal
Register
listings
at
<A
HREF="
http://
frwebgate.
access.
gpo.
gov/
cgi
bin/
leaving.
cgi?
from=
leavingFR.
h
tml&
log=
linklog&
to=
http://
www.
epa.
gov/
fedrgstr/">
http://
www.
epa.
gov/
fedrgstr/</
A
>.
2.
In
person.
The
Agency
has
established
an
official
record
for
this
action
under
docket
ID
number
OPP
2002
0257.
The
official
record
consists
of
the
documents
specifically
referenced
in
this
action,
any
public
comments
received
during
an
applicable
comment
period,
and
other
information
related
to
this
action,
including
any
information
claimed
as
Confidential
Business
Information
(CBI).
This
official
record
includes
the
documents
that
are
physically
located
in
the
docket,
as
well
as
the
documents
that
are
referenced
in
those
documents.
The
public
version
of
the
official
record
does
not
include
any
information
claimed
as
CBI.
The
public
version
of
the
official
record,
which
includes
printed,
paper
versions
of
any
electronic
comments
submitted
during
an
applicable
comment
period
is
availabe
for
inspection
in
the
Public
Information
and
Records
Integrity
Branch
(PIRIB),
Rm.
119,
Crystal
Mall
<greek
i>
2,
1921
Jefferson
Davis
Hwy.,
Arlington,
VA,
from
8:
30
a.
m.
to
4
p.
m.,
Monday
through
Friday,
excluding
legal
holidays.
The
PIRIB
telephone
number
is
(703)
305
5805.
C.
How
and
to
Whom
Do
I
Submit
Comments?
You
may
submit
comments
through
the
mail,
in
person,
or
electronically.
To
ensure
proper
receipt
by
EPA,
it
is
imperative
that
you
identify
docket
ID
number
OPP
2002
0257
in
the
subject
line
on
the
first
page
of
your
response.
1.
By
mail.
Submit
your
written
comments
to:
Public
Information
and
Records
Integrity
Branch
(PIRIB),
Information
Resources
and
Services
Division
(7502C),
Office
of
Pesticide
Programs
(OPP),
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460.
2.
In
person
or
by
courier.
Deliver
your
written
comments
to:
Public
Information
and
Records
Integrity
Branch
(PIRIB),
Information
Resources
and
Services
Division
(7502C),
Office
of
Pesticide
Programs
(OPP),
Environmental
Protection
Agency,
Rm.
119,
Crystal
Mall
<greek
i>
2,
1921
Jefferson
Davis
Hwy.,
Arlington,
VA.
The
PIRIB
is
open
from
8:
30
a.
m.
to
4
p.
m.,
Monday
through
Friday,
excluding
legal
holidays.
The
PIRIB
telephone
number
is
(703)
305
5805.
3.
Electronically.
You
may
submit
your
comments
electronically
by
e
mail
to:
<A
HREF="
mailto:
opp
docket@
epa.
gov">
opp
docket@
epa.
gov</
A>.
Do
not
su
bmit
any
information
electronically
that
you
consider
to
be
CBI.
Use
WordPerfect
6.1/
8.0/
9.0
or
ASCII
file
format,
and
avoid
the
use
of
special
characters
or
any
form
of
encryption.
Be
sure
to
identify
by
docket
ID
number
OPP
2002
0257.
You
may
also
file
a
request
online
at
many
Federal
Depository
Libraries.
II.
Background
Amendments
to
FIFRA
enacted
November
28,
1975,
include
a
requirement
under
section
25(
d)
that
notices
of
intent
to
cancel
or
reclassify
pesticide
registrations
pursuant
to
section
6(
b)(
2),
as
well
as
proposed
and
final
forms
of
rulemaking
pursuant
to
section
25(
a),
be
submitted
to
FIFRA/
SAP
prior
to
being
made
public
or
issued
to
a
registrant.
In
accordance
with
section
25(
d),
the
FIFRA/
SAP
is
to
have
an
opportunity
to
comment
on
the
health
and
environmental
impact
of
such
actions.
The
Panel
shall
also
make
comments,
evaluations,
and
recommendations
for
operating
guidelines
to
improve
the
effectiveness
and
quality
of
analyses
made
by
Agency
scientists.
In
accordance
with
the
statute,
the
FIFRA/
SAP
is
composed
of
seven
permanent
members,
selected
and
appointed
by
the
Deputy
Administrator
of
EPA
from
nominees
submitted
by
both
the
National
Science
Foundation
(NSF)
and
the
National
Institutes
of
Health
(NIH).
The
Agency
is,
at
this
time,
selecting
three
new
members
to
serve
on
the
Panel
as
a
result
of
membership
terms
that
will
expire
this
year.
EPA's
Office
of
Prevention,
Pesticides
and
Toxic
Substances
(OPPTS)
requested
nominations
of
experts
to
be
selected
from,
but
not
limited
to,
the
fields
of
pediatric
medicine,
biostatistics,
and
toxicology/
veterinary
medicine.
Nominees
should
be
well
published
and
current
in
their
fields
of
expertise.
The
statute
further
stipulates
that
we
publish
the
name,
address,
professional
affiliation,
and
a
brief
biographical
sketch
of
each
nominee
in
the
Federal
Register
and
solicit
public
comments
concerning
the
candidates
nominated.
III.
Charter
A
Charter
for
the
FIFRA/
SAP,
dated
October
25,
2000,
was
issued
in
accordance
with
the
requirements
of
the
Federal
Advisory
Committee
Act
(FACA),
Public
Law
92
463,
86
Stat.
770
(5
U.
S.
C.
App.
I).
The
qualifications
of
members
as
provided
by
the
Charter
follow.
A.
Qualifications
of
Members
Members
are
scientists
who
have
sufficient
professional
qualifications,
including
training
and
experience,
to
be
capable
of
providing
expert
comments
as
to
the
impact
on
health
and
the
environment
of
regulatory
actions
under
sections
6(
b)
and
25(
a)
of
FIFRA.
No
persons
shall
be
ineligible
to
serve
on
the
Panel
by
reason
of
their
membership
on
any
other
advisory
committee
to
a
Federal
department
or
agency
or
their
employment
by
a
Federal
department
or
agency
(except
EPA).
The
Deputy
Administrator
appoints
individuals
to
serve
on
the
Panel
for
staggered
terms
of
4
years.
Panel
members
are
subject
to
the
provisions
of
40
CFR
part
3,
subpart
F,
Standards
of
Conduct
for
Special
Government
Employees,
which
include
rules
regarding
conflicts
of
interest.
Each
nominee
selected
by
the
Deputy
Administrator,
before
being
formally
appointed,
is
required
to
submit
a
[[
Page
61096]]
Confidential
Statement
of
Employment
and
Financial
Interests,
which
shall
fully
disclose,
among
other
financial
interests,
the
nominee's
sources
of
research
support,
if
any.
In
accordance
with
section
25(
d)
of
FIFRA,
the
Deputy
Administrator
shall
require
all
nominees
to
the
Panel
to
furnish
information
concerning
their
professional
qualifications,
educational
background,
employment
history,
and
scientific
publications.
The
Agency
is
required
to
publish
in
the
Federal
Register
the
name,
address,
and
professional
affiliations
of
each
nominee
and
to
seek
public
comment
on
the
nominees.
B.
Applicability
of
Existing
Regulations
With
respect
to
the
requirements
of
section
25(
d)
of
FIFRA
that
the
Administrator
promulgate
regulations
regarding
conflicts
of
interest,
the
Charter
provides
that
EPA's
existing
regulations
applicable
to
special
government
employees,
which
include
advisory
committee
members,
will
apply
to
the
members
of
the
FIFRA/
SAP.
These
regulations
appear
in
40
CFR
part
3,
subpart
F.
In
addition,
the
Charter
provides
for
open
meetings
with
opportunities
for
public
participation.
C.
Process
of
Obtaining
Nominees
In
accordance
with
the
provisions
of
section
25(
d)
of
FIFRA,
EPA,
in
April
2002,
requested
the
NIH
and
NSF
to
nominate
scientists
to
fill
three
vacancies
occurring
on
the
Panel.
The
Agency
requested
nomination
of
experts
in
the
fields
of
toxicology/
veterinary
medicine,
clinical
pediatric
research,
and
biostatistics,
and
related
fields.
NIH
and
NSF
responded
by
letter,
providing
the
Agency
with
six
nominees
each.
Three
of
the
twelve
nominees
withdrew
their
names
from
consideration,
because
they
believed
their
current
responsibilities
would
preclude
active
participation
in
FIFRA/
SAP
meetings.
IV.
Nominees
The
following
are
the
names,
addresses,
professional
affiliations,
and
selected
biographical
data
of
nominees
being
considered
for
membership
on
the
FIFRA/
SAP.
The
Agency
expects
to
select
three
of
the
nominees
to
fill
three
vacancies
occurring
during
the
calendar
year
2002.
A.
Nominations
for
the
Field
of
Toxicology/
Veterinary
Medicine
1.
Nominee.
Faustman,
Elaine
M.,
Ph.
D.,
D.
A.
B.
T.,
Professor
and
Director,
Institute
for
Risk
Analysis
and
Risk
Communication,
School
of
Public
Health
and
Community
Medicine,
University
of
Washington.
i.
Expertise.
Reproductive
and
developmental
toxicology
of
metals,
in
vitro
and
molecular
biological
methodologies,
quantitative
risk
assessment.
ii.
Education.
A.
B.
Chemistry
and
Zoology,
Hope
College,
1976;
Ph.
D.,
Pharmacology/
Toxicology,
Michigan
State
University,
1980;
postdoctoral
studies
in
Toxicology
and
Environmental
Pathology,
School
of
Medicine,
University
of
Washington.
iii.
Professional
experience.
Dr.
Faustman
has
served
on
the
National
Institute
of
Environmental
Health
Sciences/
National
Toxicology
Program
(NIEHS
NTP)
Board
of
Scientific
Counselors
and
the
National
Academy
of
Sciences
Committee
in
Toxicology.
She
has
also
served
as
Associate
Editor
of
Fundamental
and
Applied
Toxicology
and
on
the
editorial
boards
of
Reproductive
Toxicology
and
Toxicology
Methods.
Dr.
Faustman
is
the
Director
of
EPA
NIEHS
funded
Child
Health
Care
Center
which
is
evaluating
key
mechanisms
defining
children's
susceptibility
to
pesticides.
She
is
an
elected
Fellow
of
the
American
Association
for
the
Advancement
of
Science,
and
has
recently
served
as
Chair
for
the
American
Academy
of
Sciences
Committee
on
Developmental
Toxicology.
She
is
a
member
of
the
NIEHS
NTP
Committee
on
Alternative
Toxicology
Methods.
2.
Nominee.
Froines,
John
R.,
Ph.
D.,
Professor,
Department
of
Environmental
Health
Sciences,
UCLA
School
of
Public
Health;
Director,
UCLA
Center
for
Occupational
and
Environmental
Health;
Director,
Southern
California
Particle
Center
and
Supersite.
i.
Expertise.
Chemical
toxicology
and
risk
assessment,
biomarkers
and
toxicokinetics
of
chemical
carcinogens,
policy
and
priorities
in
environmental
and
occupational
health.
ii.
Education.
B.
S.
Chemistry,
University
of
California,
Berkeley,
1963;
M.
S.,
Physical
Organic
Chemistry,
Yale
University,
1964;
Ph.
D.,
Physical
Organic
Chemistry,
Yale
University,
1967.
iii.
Professional
experience.
Dr.
Froines
has
served
on
the
National
Academy
of
Sciences
(NAS)
Committee
on
Environmental
Epidemiology,
including
principal
authorship
of
two
chapters
on
exposure
assessment
in
two
NAS
reports.
He
has
served
as
chair
of
the
Advisory
Panel
for
the
Office
of
Technology
Assessment
project,
``
Gauging
Control
Technology
and
Regulatory
Impacts
in
Occupational
Safety
and
Health''
(1992
1995).
He
has
served
on
the
Federal
Committee
to
the
Department
of
Energy
(DOE)
on
the
Beryllium
Standard
(1997
1998),
on
the
Carcinogen
Identification
Committee
(1995
2001),
and
the
President's
(University
of
California
U.
C.)
committees
on
health,
safety,
and
environmental
concerns
with
the
three
national
laboratories
managed
by
U.
C.
Dr.
Froines
is
presently
Chairman
of
the
Scientific
Review
Panel,
Air
Resources
Board;
member
of
the
National
Toxicology
Program
Board
of
Scientific
Counselors;
member
of
several
committees
of
the
South
Coast
Air
Quality
Management
District
in
southern
California,
and
a
member
of
the
Scientific
Advisory
Board,
Center
for
Vulnerable
Populations
Research.
3.
Nominee.
Isom,
Gary
E.,
Ph.
D.,
Professor
of
Toxicology,
Vice
President
for
Research,
and
Dean
of
the
Graduate
School,
Purdue
University.
i.
Expertise.
Chemical
and
cyanide
toxicology
and
related
neurological
disorders.
ii.
Education.
B.
S.,
Pharmacy,
Idaho
State
University,
Ph.
D.,
Pharmacology,
Washington
State
University,
1973.
iii.
Professional
experience.
Associate
Professor
of
Toxicology
at
Idaho
State
University
and
at
Purdue
University.
Dr.
Isom
has
served
on
numerous
review
panels
for
NIH
and
NSF.
He
has
published
in
the
journals
Toxicology
and
Applied
Pharmacology,
Journal
of
Neurochemistry,
Neurotoxicology,
and
the
Journal
of
Pharmacology
and
Experimental
Therapeutics.
Dr.
Isom
presently
serves
on
the
Advisory
Committee
for
the
Engineering
Directorate
at
NSF.
In
1999
he
was
appointed
to
the
Science
and
Technology
Advisory
Board
of
the
Defense
Intelligence
Agency.
4.
Nominee.
Russell,
Stephen
W.,
D.
V.
M.,
Ph.
D.,
Wilkinson
Distinguished
Professor
of
Cancer
Research,
University
of
Kansas
Cancer
Center,
University
of
Kansas
Medical
Center,
Kansas
City,
KS
(emeritus
since
2001).
i.
Expertise.
Immunopathology.
ii.
Education.
B.
S.
Enology,
University
of
California,
Davis,
1960;
D.
V.
M.,
UC
Davis,
1966;
Ph.
D.,
Comparative
Pathology,
UC
Davis,
1972;
postdoctoral
fellowship,
Scripps
Clinic
and
Research
Foundation,
immunopathology,
1972
1973.
iii.
Professional
experience.
Dr.
Russell
has
served
as
member
and
as
Chair
of
the
Animal
Resources
Review
Committee
of
NIH
(1986
1990).
He
has
served
on
a
Special
Review
Committee
on
Animal
Models
of
Solid
Tumors
for
NIH;
the
Immunological
Sciences
Review
Panel,
US
Army
Breast
Cancer
Research
Program;
and
on
the
Board
of
Scientific
Counselors,
National
Center
for
Research
Resources,
NIH.
Dr.
Russell
has
served
on
editorial
boards
of,
and
[[
Page
61097]]
has
published
in,
several
professional
journals,
including
Journal
of
Leucocyte
Biology,
Journal
of
Immunology,
Yearbook
of
Pathology
and
Clinical
Pathology,
Infection
and
Immunity,
and
Gene.
Dr.
Russell
was
Director
of
the
University
of
Kansas
Cancer
Center,
University
of
Kansas
Medical
Center,
Kansas
City,
KS
from
1991
1995.
He
was
Associate
Director
for
Research
at
the
University
of
Kansas
Cancer
Center
from
1987
1991.
From
1980
1987
he
was
Professor
and
Chairman
of
the
Department
of
Comparative
and
Experimental
Pathology,
College
of
Veterinary
Medicine,
and
Professor,
Departments
of
Pathology
and
Immunology
and
Medical
Microbiology,
College
of
Medicine,
University
of
Florida,
Gainesville,
FL.
B.
Nominations
for
the
Field
of
Clinical
Pediatrics
Research
1.
Nominee.
Frank,
Michael
M.,
M.
D.,
Professor
and
Chairman,
Department
of
Pediatrics;
Professor
of
Medicine;
Professor
of
Immunology,
Duke
University.
i.
Expertise.
Pediatric
Immunology
and
Toxicology.
Education.
A.
B.,
Zoology,
University
of
Wisconsin,
1956;
M.
D.,
Harvard
Medical
School,
1960.
ii.
Professional
experience.
Chief,
Laboratory
of
Clinical
Investigation,
National
Institute
of
Allergy
and
Infectious
Diseases,
National
Institutes
of
Health,
1977
1990;
Clinical
Director,
NIAID,
NIH,
1977
1990;
Head,
Clinical
Immunology
Section,
Laboratory
of
Clinical
Investigation,
NIAID,
NIH,
1971
1990;
Senior
Investigator,
LCI,
NIAID,
NIH,
1968
1971.
Dr.
Frank
has
served
on
editorial
boards
of,
and
has
published
in,
several
professional
journals,
including
Journal
of
Immunology,
Journal
of
Clinical
Investigation,
Blood,
Reviews
in
Infectious
Diseases,
Current
Opinions
in
Pediatrics,
and
Medicine.
2.
Nominee.
Handwerger,
Stuart,
M.
D.,
Director
of
Endocrinology,
Cincinnati
Children's
Hospital
Medical
Center,
Cincinnati,
OH;
Robert
and
Mary
Shoemaker
Professor
of
Pediatrics
and
Professor
of
Cell
Biology,
Neurobiology
and
Anatomy,
University
of
Cincinnati
College
of
Medicine,
Cincinnati,
OH.
i.
Expertise.
Placental
and
uterine
biology,
fetal
and
reproductive
endocrinology,
diagnosis
and
treatment
of
growth
disorders.
ii.
Education.
B.
A.,
Biological
Sciences,
Johns
Hopkins
University,
Baltimore,
MD,
1960;
M.
D.,
University
of
Maryland,
Baltimore,
MD,
1964.
iii.
Professional
experience.
Professor
of
Cell
Biology,
Neurobiology
and
Anatomy,
Senior
Member,
Developmental
Biology
Program,
Member,
Barrett
Cancer
Center,
University
of
Cincinnati
College
of
Medicine,
1990
to
present;
Director,
Post
Doctoral
Training,
Department
of
Pediatrics,
Cincinnati
Children's
Medical
Center,
Cincinnati,
OH
1993
to
present.
Dr.
Handwerger
was
Director
of
the
Division
of
Endocrinology,
Department
of
Pediatrics,
Duke
University
School
of
Medicine,
Durham,
NC,
1979
to
1990.
During
this
same
time
period,
he
was
a
Senior
Member,
Duke
Comprehensive
Cancer
Center,
Duke
University
School
of
Medicine.
C.
Nominations
for
the
Field
of
Biostatistics
1.
Nominee.
Bailer,
A.
John,
Ph.
D.,
Professor,
Department
of
Mathematics
and
Statistics,
and
affiliate
member,
Department
of
Zoology,
Miami
University,
Oxford,
OH.
i.
Expertise.
Biostatistics,
risk
estimation
and
characterization.
ii.
Education.
B.
S.,
Mathematics
and
Statistics,
1978;
B.
A.,
Psychology,
1982,
Miami
University,
Oxford,
OH;
M.
A.,
Quantitative
Psychology,
University
of
North
Carolina,
Chapel
Hill,
1984;
Ph.
D.,
Biostatistics,
University
of
North
Carolina,
Chapel
Hill,
1986.
iii.
Professional
experience.
Professor
of
Statistics,
Miami
University,
Oxford,
OH,
1988
to
present;
invited
participant
in
technical
workshop
on
Whole
Effluent
Toxicity
sponsored
by
the
Society
of
Environmental
Toxicology
and
Chemistry,
September
1995;
member
on
two
subcommittees
of
the
Board
of
Scientific
Counselors
of
the
National
Toxicology
Program,
1997
to
2000;
member
of
International
Statistical
Institute
risk
assessment
committee,
2000
to
present;
member
of
statistics
subcommittee
at
NIEHS/
NTP
Low
Dose
Peer
Review
for
Endocrine
Disruptors,
Research
Triangle,
NC,
2000;
member
of
National
Research
Council
Subcommittee
Toxologic
Assessment
of
Low
Level
Exposures
to
Chemical
Warfare,
2001
to
present;
consultant
to
NAS
committee
``
Implications
of
Dioxin
in
the
Food
Supply''
2001.
2.
Nominee.
Doerge,
Rebecca
W.,
Ph.
D.,
Associate
Professor
of
Agronomy
and
Statistics,
Purdue
University,
West
Lafayette,
IN.
i.
Expertise.
Statistical
genomics,
biostatistics.
ii.
Education.
B.
S.,
Mathematics,
University
of
Utah,
1986;
M.
Stat.,
University
of
Utah,
1988;
Ph.
D.,
Statistics,
North
Carolina
State
University,
1993;
post
doctoral
fellow,
Department
of
Biometrics
and
Plant
Breeding,
Cornell
University,
1995.
iii.
Professional
experience.
Dr.
Doerge
has
won
awards
for
her
teaching
skills,
among
them,
Outstanding
Teacher
of
Undergraduates
in
the
School
of
Science,
Purdue
University,
1998.
Dr.
Doerge
has
published
in
Endocrinology,
Journal
of
Immunology,
American
Journal
of
Pathology,
Statistical
Science,
Heredity,
Genetics,
and
Trends
in
Genetics.
She
will
co
chair
a
meeting
on
Quantitative
Genetics
and
Genomics,
in
February
2003.
3.
Nominee.
Heeringa,
Steven
G.,
Ph.
D.,
Director
of
the
Division
of
Surveys
and
Technologies,
Institute
for
Social
Research,
University
of
Michigan,
Ann
Arbor,
MI.
i.
Expertise.
Statistical
methods,
design
and
analysis.
ii.
Education.
Ph.
D.,
Biostatistics,
University
of
Michigan.
iii.
Professional
experience
Dr.
Heeringa
has
over
25
years
of
statistical
sampling
experience,
directing
the
development
of
the
Michigan
Institute
for
Social
Research
(ISR),
national
sample
design
as
well
as
sample
designs
for
ISR's
major
longitudinal
and
cross
sectional
survey
programs.
During
this
period
he
has
been
actively
involved
in
research
in
statistical
methods
and
procedures
such
as
weighting,
variance
estimation
and
the
imputation
of
missing
data
that
are
required
in
the
analysis
of
sample
survey
data.
His
publications
in
these
areas
have
been
extensive.
He
has
served
as
an
advisor
to
panels
of
the
NIH
and
the
World
Health
Organization
(WHO).
Since
2000,
Dr.
Heeringa
has
served
as
an
ad
hoc
member
of
more
than
10
EPA
scientific
review
panels.
He
teaches
survey
sampling
methods
internationally,
and
serves
as
a
sample
design
consultant
to
a
wide
variety
of
international
research
programs.
List
of
Subjects
Environmental
protection,
Pesticide
and
pests.
Dated:
September
19,
2002.
Joseph
Merenda,
Director,
Office
of
Science
Coordination
and
Policy.
[FR
Doc.
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strong><
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BILLING
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</
PRE>
| epa | 2024-06-07T20:31:43.908172 | regulations | {
"license": "Public Domain",
"url": "https://downloads.regulations.gov/EPA-HQ-OPP-2002-0257-0001/content.txt"
} |
EPA-HQ-OPP-2002-0258-0001 | Notice | "2002-09-16T04:00:00" | Exposure Modeling Work Group (EMWG); Notice of Public Meeting | 58423
Federal
Register
/
Vol.
67,
No.
179
/
Monday,
September
16,
2002
/
Notices
EXEMPT
Docket
No.
Date
filed
Presenter
or
requester
1.
CP01–
415–
000
....................................................................................................
8–
19–
02
Steven
D.
Irvin
2
CP01–
415–
000
.....................................................................................................
8–
22–
02
Sam
Dickson/
Richard
Slate.
3.
CP01–
415–
000
....................................................................................................
8–
22–
02
Brenda
R.
Durham.
4.
CP00–
415–
000
....................................................................................................
8–
22–
02
Stephen
B.
Corcoran.
5.
CP01–
415–
000
....................................................................................................
8–
24–
02
Donald
L.
Moss,
Jr.
6.
CP01–
415–
000
....................................................................................................
8–
24–
02
Phillip
J.
Kirk,
Jr.
7.
CP01–
415–
000
....................................................................................................
8–
29–
02
Andrew
S.
Hall.
8.
CP01–
415–
000
....................................................................................................
8–
29–
02
Wayne
Sexton.
9.
CP01–
415–
000
....................................................................................................
8–
29–
02
Gregory
R.
Seibert.
10.
CP01–
415–
000
..................................................................................................
8–
29–
02
Sharon
J.
Garner.
11.
CP01–
415–
000
..................................................................................................
9–
3–
02
John
E.
Grogan.
Linwood
A.
Watson,
Jr.,
Deputy
Secretary.
[FR
Doc.
02Ð
23445
Filed
9Ð
13Ð
02;
8:
45
am]
BILLING
CODE
6717–
01–
P
ENVIRONMENTAL
PROTECTION
AGENCY
[FRL–
7377–
1]
Environmental
Laboratory
Advisory
Board
(ELAB)
Meeting
Date,
and
Agenda
AGENCY:
Environmental
Protection
Agency
(EPA).
ACTION:
Notice
of
teleconference
meeting.
SUMMARY:
The
Environmental
Protection
Agency's
Environmental
Laboratory
Advisory
Board
(ELAB)
will
have
a
teleconference
meeting
on
October
16,
2002,
at
11
A.
M.
EDT
to
discuss
the
ideas,
comments,
and
suggestions
presented
at
the
July
11
ELAB
Meeting
and
the
August
21
teleconference
call,
as
well
as
new
business.
Items
to
be
discussed
include:
(1)
Restructuring
of
the
National
Environmental
Laboratory
Accreditation
Conference
(NELAC)
to
allow
it
to
better
serve
the
future
needs
of
EPA,
the
States,
and
the
private
sector,
(2)
discussion
of
ELAB
recommendations
to
EPA,
(3)
recommendations
for
increasing
small
laboratory
participation
in
NELAC,
and
(4)
recommendations
for
increasing
the
number
of
States
that
are
Accrediting
Authorities,
and
the
upcoming
November
ELAB
meeting
in
Santa
Fe,
New
Mexico.
ELAB
is
soliciting
input
from
the
public
on
these
and
other
issues
related
to
the
National
Environmental
Laboratory
Accreditation
Program
(NELAP)
and
the
NELAC
standards.
Written
comments
on
NELAP
laboratory
accreditation
and
the
NELAC
standards
are
encouraged
and
should
be
sent
to
Mr.
Edward
Kantor,
DFO,
P.
O.
Box
93478,
Las
Vegas,
NV
89193Ð
3478,
faxed
to
(702)
798Ð
2261,
or
e
mailed
to
kantor.
edward@
epa.
gov.
Members
of
the
public
are
invited
to
listen
to
the
teleconference
calls
and,
time
permitting,
will
be
allowed
to
comment
on
issues
discussed
during
this
and
previous
ELAB
meetings.
Those
persons
interested
in
attending
should
call
Edward
Kantor
at
702Ð
798Ð
2690
to
obtain
teleconference
information.
The
number
of
lines
are
limited
and
will
be
distributed
on
a
first
come,
first
serve
basis.
Preference
will
be
given
to
a
group
wishing
to
attend
over
a
request
from
an
individual.
John
G.
Lyon,
Director,
Environmental
Sciences
Division,
National
Environmental
Research
Laboratory.
[FR
Doc.
02Ð
23472
Filed
9Ð
13Ð
02;
8:
45
am]
BILLING
CODE
6560–
50–
P
ENVIRONMENTAL
PROTECTION
AGENCY
[OPP–
2002–
0258;
FRL–
7274–
6]
Exposure
Modeling
Work
Group
(EMWG);
Notice
of
Public
Meeting
AGENCY:
Environmental
Protection
Agency
(EPA).
ACTION:
Notice.
SUMMARY:
The
Exposure
Modeling
Work
Group
(EMWG)
will
hold
a
1Ð
day
meeting
on
September
24,
2002.
This
notice
announces
the
location
and
time
for
the
meeting
and
sets
forth
the
tentative
agenda
topics.
DATES:
The
meeting
will
be
held
on
September
24,
2002,
from
9
a.
m.
to
3
p.
m.
ADDRESSES:
This
meeting
will
be
held
at
the
Office
of
Pesticide
Programs
(OPP),
Environmental
Protection
Agency,
Crystal
Mall
#2,
Room
1110,
1921
Jefferson
Davis
Hwy.,
Arlington,
VA.
Comments
may
be
submitted
by
mail,
electronically,
or
in
person.
Please
follow
the
detailed
instructions
for
each
method
as
provided
in
Unit
I.
of
the
SUPPLEMENTARY
INFORMATION.
To
ensure
proper
receipt
by
EPA,
it
is
imperative
that
you
identify
docket
ID
number
OPPÐ
2002Ð
0258
in
the
subject
line
on
the
first
page
of
your
response.
FOR
FURTHER
INFORMATION
CONTACT:
Dirk
F.
Young,
Environmental
Fate
and
Effects
Division
(7507C)
Office
of
Pesticide
Programs,
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460;
telephone
number:
(703)
605Ð
0206;
fax
number:
(703)
308Ð
6309;
e
mail
address:
young.
dirk@
epa.
gov.
SUPPLEMENTARY
INFORMATION:
I.
General
Information
A.
Does
this
Action
Apply
to
Me?
This
action
is
directed
to
the
public
in
general.
This
action
may,
however,
be
of
interest
to
Tribes
with
pesticide
programs
or
pesticide
interests.
Since
other
entities
may
also
be
interested,
the
Agency
has
not
attempted
to
describe
all
the
specific
entities
that
may
be
affected
by
this
action.
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
Additional
Information,
Including
Copies
of
this
Document
and
Other
Related
Documents?
1.
Electronically.
You
may
obtain
electronic
copies
of
this
document,
and
certain
other
related
documents
that
might
be
available
electronically,
from
the
EPA
Internet
Home
Page
at
http://
www.
epa.
gov/.
To
access
this
document,
on
the
Home
Page
select
``
Laws
and
Regulations,
''
``
Regulations
and
Proposed
Rules,
''
and
then
look
up
the
entry
for
this
docuent
under
the
``
Federal
RegisterÑ
Environmental
Documents.
''
You
can
also
go
directly
to
the
Federal
Register
listings
at
http://
www.
epa.
gov/
fedrgstr/.
2.
In
person.
The
Agency
has
established
an
official
record
for
this
action
under
docket
ID
number
OPPÐ
2002Ð
0258.
The
official
record
consists
of
the
documents
specifically
referenced
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Federal
Register
/
Vol.
67,
No.
179
/
Monday,
September
16,
2002
/
Notices
in
this
action,
any
public
comments
received
during
an
applicable
comment
period,
and
other
information
related
to
this
action,
including
any
information
claimed
as
Confidential
Business
Information
(CBI).
This
official
record
includes
the
documents
that
are
physically
located
in
the
docket,
as
well
as
the
documents
that
are
referenced
in
those
documents.
The
public
version
of
the
official
record
does
not
include
any
information
claimed
as
CBI.
The
public
version
of
the
official
record,
which
includes
printed,
paper
versions
of
any
electronic
comments
submitted
during
an
applicable
comment
period,
is
available
for
inspection
in
the
Public
Information
and
Records
Integrity
Branch
(PIRIB),
Rm.
119,
Crystal
Mall
#2,
1921
Jefferson
Davis
Hwy.,
Arlington,
VA,
from
8:
30
a.
m.
to
4
p.
m.,
Monday
through
Friday,
excluding
legal
holidays.
The
PIRIB
telephone
number
is
(703)
305Ð
5805.
C.
How
and
to
Whom
Do
I
Submit
Comments?
You
may
submit
comments
through
the
mail,
in
person,
or
electronically.
To
ensure
proper
receipt
by
EPA,
it
is
imperative
that
you
identify
docket
ID
number
OPPÐ
2002Ð
0258
in
the
subject
line
on
the
first
page
of
your
response.
1.
By
mail.
Submit
your
comments
to:
Public
Information
and
Records
Integrity
Branch
(PIRIB),
Information
Resources
and
Services
Division
(7502C),
Office
of
Pesticide
Programs
(OPP),
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460.
2.
In
person
or
by
courier.
Deliver
your
comments
to:
Public
Information
and
Records
Integrity
Branch
(PIRIB),
Information
Resources
and
Services
Division
(7502C),
Office
of
Pesticide
Programs
(OPP),
Environmental
Protection
Agency,
Rm.
119,
Crystal
Mall
#2,
1921
Jefferson
Davis
Hwy.,
Arlington,
VA.
The
PIRIB
is
open
from
8:
30
a.
m.
to
4
p.
m.,
Monday
through
Friday,
excluding
legal
holidays.
The
PIRIB
telephone
number
is
(703)
305Ð
5805.
3.
Electronically.
You
may
submit
your
comments
electronically
by
e
mail
to:
opp
docket@
epa.
gov,
or
you
can
submit
a
computer
disk
as
described
above.
Do
not
submit
any
information
electronically
that
you
consider
to
be
CBI.
Avoid
the
use
of
special
characters
and
any
form
of
encryption.
Electronic
submissions
will
be
accepted
in
WordPerfect
6.1/
8.0
or
ASCII
file
format.
All
comments
in
electronic
form
must
be
identified
by
docket
ID
number
OPPÐ
2002Ð
0258.
Electronic
comments
may
also
be
filed
online
at
many
Federal
Depository
Libraries.
D.
How
Should
I
Handle
CBI
that
I
Want
to
Submit
to
the
Agency?
Do
not
submit
any
information
electronically
that
you
consider
to
be
CBI.
You
may
claim
information
that
you
submit
to
EPA
in
response
to
this
document
as
CBI
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.
In
addition
to
one
complete
version
of
the
comment
that
includes
any
information
claimed
as
CBI,
a
copy
of
the
comment
that
does
not
contain
the
information
claimed
as
CBI
must
be
submitted
for
inclusion
in
the
public
version
of
the
official
record.
Information
not
marked
confidential
will
be
included
in
the
public
version
of
the
official
record
without
prior
notice.
If
you
have
any
questions
about
CBI
or
the
procedures
for
claiming
CBI,
please
consult
the
person
listed
under
FOR
FURTHER
INFORMATION
CONTACT.
E.
What
Should
I
Consider
as
I
Prepare
My
Comments
for
EPA?
You
may
find
the
following
suggestions
helpful
for
preparing
your
comments:
1.
Explain
your
views
as
clearly
as
possible.
2.
Describe
any
assumptions
that
you
used.
3.
Provide
copies
of
any
technical
information
and/
or
data
you
used
that
support
your
views.
4.
If
you
estimate
potential
burden
or
costs,
explain
how
you
arrived
at
the
estimate
that
you
provide.
5.
Provide
specific
examples
to
illustrate
your
concerns.
6.
Offer
alternative
ways
to
improve
the
notice
or
collection
activity.
7.
Make
sure
to
submit
your
comments
by
the
deadline
in
this
notice.
8.
To
ensure
proper
receipt
by
EPA,
be
sure
to
identify
the
docket
ID
number
assigned
to
this
action
in
the
subject
line
on
the
first
page
of
your
response.
You
may
also
provide
the
name,
date,
and
Federal
Register
citation.
II.
Tentative
Agenda:
This
unit
provides
tentative
agenda
topics
for
the
1Ð
day
meeting.
1.
Welcome
and
introductions.
2.
Disseminate
new
EMWG
charter.
3.
Old
action
items.
4.
Brief
updates:
Pesticide
Root
Zone/
Exposure
Analysis
Modeling
System
(PRZM/
EXAMS)
model.
Spray
drift
task
force
progress.
Rice
modeling.
European
union
activities.
USDA
Agricultural
Research
Service
Activities.
Environmental
fate
data
base.
New
meteorological
files.
Turf
umbrella.
5.
Environmental
Fate
and
Effects
Division
priorities
for
FY
2003.
6.
Refined
risk
assessment.
7.
PRZM/
EXAMS
scenarios:
industry
feedback.
8.
Sci
Grow
and
PGW
data
base.
9.
Industry
thoughts
on
ground
water
modeling.
10.
Update
on
WARP.
11.
Estuary
model
development.
12.
Update
on
standard
water
body
model,
fast
solution.
13.
Curve
number/
moisture
relationship.
List
of
Subjects
Environmental
protection,
Pesticide
and
pests.
September
10,
2002,
Steven
Bradbury,
Acting
Division
Director,
Environmental
Fate
and
Effects
Division,
Office
of
Pesticide
Programs.
[FR
Doc.
02Ð
23580
Filed
9Ð
12Ð
02;
1:
25
pm]
BILLING
CODE
6560–
50–
S
ENVIRONMENTAL
PROTECTION
AGENCY
[FRL–
7376–
9]
Proposed
Administrative
Settlement
Under
the
Comprehensive
Environmental
Response,
Compensation
and
Liability
Act;
Amchem
CERCLA
Removal
Site
AGENCY:
Environmental
Protection
Agency.
ACTION:
Notice;
request
for
public
comment.
SUMMARY:
In
accordance
with
section
122(
i)(
1)
of
CERCLA,
42
U.
S.
C.
9622(
i)(
1),
notice
is
hereby
given
of
a
proposed
administrative
settlement
concerning
the
Amchem
CERCLA
Removal
Site,
Ambler,
Pennsylvania.
The
administrative
settlement
was
signed
by
the
United
States
Environmental
Protection
Agency,
Region
III's
Regional
Administrator
on
August
28,
2002,
and
is
subject
to
review
by
the
public
pursuant
to
this
document.
The
Environmental
Protection
Agency
(EPA)
is
proposing
to
enter
into
a
settlement
pursuant
to
section
122(
h)
of
the
Comprehensive
Environmental
Response,
Compensation,
and
Liability
Act
of
1980,
as
amended,
(CERCLA),
42
U.
S.
C.
9622(
h).
The
proposed
settlement
resolves
EPA's
claim
for
past
response
costs
under
section
107
of
CERCLA,
42
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| epa | 2024-06-07T20:31:43.917817 | regulations | {
"license": "Public Domain",
"url": "https://downloads.regulations.gov/EPA-HQ-OPP-2002-0258-0001/content.txt"
} |
EPA-HQ-OPP-2002-0260-0001 | Notice | "2002-09-27T04:00:00" | Caffeine; Receipt of Application for Emergency Exemption, Solicitation of Public Comment.
| 61099
Federal
Register
/
Vol.
67,
No.
188
/
Friday,
September
27,
2002
/
Notices
E.
What
Should
I
Consider
as
I
Prepare
My
Comments
for
EPA?
You
may
find
the
following
suggestions
helpful
for
preparing
your
comments:
1.
Explain
your
views
as
clearly
as
possible.
2.
Describe
any
assumptions
that
you
used.
3.
Provide
copies
of
any
technical
information
and/
or
data
you
used
that
support
your
views.
4.
If
you
estimate
potential
burden
or
costs,
explain
how
you
arrived
at
the
estimate
that
you
provide.
5.
Provide
specific
examples
to
illustrate
your
concerns.
6.
Offer
alternative
ways
to
improve
the
notice
or
collection
activity.
7.
Make
sure
to
submit
your
comments
by
the
deadline
in
this
notice.
8.
To
ensure
proper
receipt
by
EPA,
be
sure
to
identify
the
docket
ID
number
assigned
to
this
action
in
the
subject
line
on
the
first
page
of
your
response.
You
may
also
provide
the
name,
date,
and
Federal
Register
citation.
II.
Background
A.
Cancellations
EPA
is
publishing
this
notice
in
response
to
the
registrant's
request
to
cancel
all
their
registrations
for
products
containing
fenamiphos,
effective
as
of
May
31,
2007.
Please
refer
to
the
table
below
for
specific
product
registrations
that
are
subject
to
cancellation.
EPA
assessed
the
risk
associated
with
the
use
of
fenamiphos
pesticide
products
and
determined
additional
data
needs
and/
or
mitigation
measures
were
necessary,
where
applicable,
to
support
the
continued
use
of
fenamiphos
products.
Consequently,
Bayer
Corporation,
the
sole
registrant
of
fenamiphos,
elected
to
request
voluntary
cancellation
of
all
their
fenamiphos
product
registrations.
Bayer
noted
its
decision
was
predicated
largely
on
the
limited
use
of
fenamiphos,
relative
to
the
expenses
associated
with
supporting
the
chemical.
In
conjunction
with
the
request
for
voluntary
cancellation,
Bayer
Corporation
has
also
agreed
to
amend
their
existing
fenamiphos
product
registrations
and
implement
interim
risk
mitigation
measures.
EPA
intends
to
accept
the
registrant's
request
barring
adverse
comments
received
during
the
30Ð
day
public
comment
period.
Pursuant
to
section
6(
f)(
1)(
A)
of
FIFRA,
Bayer
Corporation,
8400
Hawthorne
Rd.,
P.
O.
Box
4913,
Kansas
City,
MO
64120Ð
0013
has
submitted
a
request
to
cancel
their
existing
manufacturing
and
end
use
product
registrations
containing
fenamiphos,
effective
as
of
May
31,
2007.
The
product
registrations,
for
which
cancellations
were
requested,
are
identified
in
the
following
table:
Fenamiphos
Products
EPA
Registrations
Nemacur
TechnicalInsecticide
3125
269
Nemacur
Concentrate
Nematicide
Insecticide
3125
333
Nemacur
3
3125
283
Nemacur
15%
Granular
3125
283
Nemacur
10%
Turf
and
Ornamental
Nematicide
3125
237
B.
Amendments
In
addition
to
the
request
to
cancel
all
of
their
fenamiphos
product
registrations,
Bayer
has
also
agreed
to
amend
their
existing
fenamiphos
product
registrations
to:
(1)
Prohibit
all
use
and
formulation
for
use
on
extremely
vulnerable
soils
after
May
31,
2005;
(2)
cap
production
at
500,000
pounds
for
fenamiphos
manufacturinguse
products
used
in
the
United
States
for
the
year
ending
May
31,
2003;
and
(3)
cap
production
for
each
subsequent
year
at
20%
of
the
previous
year's
production
during
the
5Ð
year
phase
out
period.
Lastly,
Bayer
has
submitted
revised
labels
to
the
Agency
to
implement
the
risk
mitigation
measures
and
changes
to
the
product
labels
identified
in
the
fenamiphos
IRED
document
(i.
e.,
establishing
seasonal
maximum
application
rates
and
reducing
current
rates).
III.
Proposed
Existing
Stocks
and
Import
Tolerances
Provisions
A.
Existing
Stocks
Bayer
has
requested
voluntary
cancellation
of
the
fenamiphos
registrations
identified
in
the
table
above.
EPA
intends
to
grant
the
request
for
voluntary
cancellation,
effective
as
of
May
31,
2007.
For
purposes
of
the
cancellation
order
that
the
Agency
intends
to
issue
at
the
close
of
the
comment
period
for
this
announcement,
the
term
``
existing
stocks''
will
be
defined,
pursuant
to
EPA's
existing
stocks
policy
at
56
FR
29362,
as
those
stocks
of
a
registered
pesticide
product
which
are
currently
in
the
United
States
and
which
have
been
packaged,
labeled,
and
released
for
shipment
prior
to
the
effective
date
of
the
cancellation
or
amendment.
As
of
May
31,
2007,
all
sale
and
distribution
by
Bayer,
the
sole
registrant,
of
existing
stocks
(manufacturing
use
and
end
use
products),
shall
be
prohibited.
Persons
other
than
the
registrant
may
sell
and
distribute
such
products
until
May
31,
2008.
Use
of
stocks
in
the
channels
of
trade
may
continue
until
depleted,
except
where
prohibited
by
the
label.
Any
distribution,
sale,
or
use
of
existing
stocks
after
the
effective
date
of
the
cancellation
order
that
the
Agency
intends
to
issue
that
is
not
consistent
with
the
terms
of
that
order
will
be
considered
a
violation
of
section
12(
a)(
2)(
K)
and/
or
12(
a)(
1)(
A)
of
FIFRA.
B.
Import
Tolerances
The
registrant
anticipates
that
commodities
treated
with
fenamiphos
may
continue
to
be
imported
into
the
United
States
after
the
final
effective
date
of
cancellation,
and
after
existing
stocks
in
the
United
States
are
exhausted.
As
such,
Bayer
intends
to
support
import
tolerances
for
banana,
citrus,
grape,
pineapple,
and
garlic.
List
of
Subjects
Environmental
protection,
Chemicals,
Cancellations.
September
19,
2002.
Lois
A.
Rossi,
Director,
Special
Review
and
Reregistration
Division,
Office
of
Pesticide
Programs.
[FR
Doc.
02Ð
24648
Filed
9Ð
26Ð
02;
8:
45
am]
BILLING
CODE
6560–
50–
S
ENVIRONMENTAL
PROTECTION
AGENCY
[OPP–
2002–
0260;
FRL–
7275–
2]
Caffeine;
Receipt
of
Application
for
Emergency
Exemption,
Solicitation
of
Public
Comment
AGENCY:
Environmental
Protection
Agency
(EPA).
ACTION:
Notice.
SUMMARY:
EPA
has
received
a
quarantine
exemption
request
from
the
U.
S.
Department
of
Agriculture
Animal
and
Plant
Health
Inspection
Service
to
use
the
pesticide
caffeine
(1H
purine2,6
dione,
3,7
dihydro
1,3,7
trimethyl)
(CAS
No.
58Ð
08Ð
2)
to
treat
up
to
200
acres
of
floriculture
and
nursery
crops,
parks,
hotels
and
resort
areas,
and
forest
habitats
to
control
Coqui
and
Greenhouse
frogs.
The
Applicant
proposes
the
use
of
a
new
chemical
which
has
not
been
registered
by
EPA.
EPA
is
soliciting
public
comment
before
making
the
decision
whether
or
not
to
grant
the
exemption.
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27,
2002
/
Notices
DATES:
Comments,
identified
by
docket
ID
number
OPPÐ
2002Ð
0260
must
be
received
on
or
before
October
15,
2002.
ADDRESSES:
Comments
may
be
submitted
electronically,
by
mail,
or
through
hand
delivery/
courier.
Follow
the
detailed
instructions
as
provided
in
Unit
I.
of
the
SUPPLEMENTARY
INFORMATION.
FOR
FURTHER
INFORMATION
CONTACT:
Barbara
Madden,
Registration
Division
(7505C),
Office
of
Pesticide
Programs,
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460Ð
0001;
telephone
number:
(703)
305Ð
6463;
fax
number:
(703)
308Ð
5433;
e
mail
address:
Sec
18
Mailbox@
epamail.
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
a
federal
or
state
government
agency
involved
in
administration
of
environmental
quality
programs.
Potentially
affected
entities
may
include,
but
are
not
limited
to:
Federal
or
state
government
entity,
(NAICS
9241),
e.
g.,
Department
of
Agriculture,
Environment,
etc.
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
OPPÐ
2002Ð
0260.
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)
305Ð
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/.
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.
Certain
types
of
information
will
not
be
placed
in
the
EPA
Dockets.
Information
claimed
as
CBI
and
other
information
whose
disclosure
is
restricted
by
statute,
which
is
not
included
in
the
official
public
docket,
will
not
be
available
for
public
viewing
in
EPA's
electronic
public
docket.
EPA's
policy
is
that
copyrighted
material
will
not
be
placed
in
EPA's
electronic
public
docket
but
will
be
available
only
in
printed,
paper
form
in
the
official
public
docket.
To
the
extent
feasible,
publicly
available
docket
materials
will
be
made
available
in
EPA's
electronic
public
docket.
When
a
document
is
selected
from
the
index
list
in
EPA
Dockets,
the
system
will
identify
whether
the
document
is
available
for
viewing
in
EPA's
electronic
public
docket.
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.
EPA
intends
to
work
towards
providing
electronic
access
to
all
of
the
publicly
available
docket
materials
through
EPA's
electronic
public
docket.
For
public
commenters,
it
is
important
to
note
that
EPA's
policy
is
that
public
comments,
whether
submitted
electronically
or
in
paper,
will
be
made
available
for
public
viewing
in
EPA's
electronic
public
docket
as
EPA
receives
them
and
without
change,
unless
the
comment
contains
copyrighted
material,
CBI,
or
other
information
whose
disclosure
is
restricted
by
statute.
When
EPA
identifies
a
comment
containing
copyrighted
material,
EPA
will
provide
a
reference
to
that
material
in
the
version
of
the
comment
that
is
placed
in
EPA's
electronic
public
docket.
The
entire
printed
comment,
including
the
copyrighted
material,
will
be
available
in
the
public
docket.
Public
comments
submitted
on
computer
disks
that
are
mailed
or
delivered
to
the
docket
will
be
transferred
to
EPA's
electronic
public
docket.
Public
comments
that
are
mailed
or
delivered
to
the
docket
will
be
scanned
and
placed
in
EPA's
electronic
public
docket.
Where
practical,
physical
objects
will
be
photographed,
and
the
photograph
will
be
placed
in
EPA's
electronic
public
docket
along
with
a
brief
description
written
by
the
docket
staff.
C.
How
and
To
Whom
Do
I
Submit
Comments?
You
may
submit
comments
electronically,
by
mail,
or
through
hand
delivery/
courier.
To
ensure
proper
receipt
by
EPA,
identify
the
appropriate
docket
ID
number
in
the
subject
line
on
the
first
page
of
your
comment.
Please
ensure
that
your
comments
are
submitted
within
the
specified
comment
period.
Comments
received
after
the
close
of
the
comment
period
will
be
marked
``
late.
''
EPA
is
not
required
to
consider
these
late
comments.
If
you
wish
to
submit
CBI
or
information
that
is
otherwise
protected
by
statute,
please
follow
the
instructions
in
Unit
I.
D.
Do
not
use
EPA
Dockets
or
e
mail
to
submit
CBI
or
information
protected
by
statute.
1.
Electronically.
If
you
submit
an
electronic
comment
as
prescribed
in
this
unit,
EPA
recommends
that
you
include
your
name,
mailing
address,
and
an
email
address
or
other
contact
information
in
the
body
of
your
comment.
Also
include
this
contact
information
on
the
outside
of
any
disk
or
CD
ROM
you
submit,
and
in
any
cover
letter
accompanying
the
disk
or
CD
ROM.
This
ensures
that
you
can
be
identified
as
the
submitter
of
the
comment
and
allows
EPA
to
contact
you
in
case
EPA
cannot
read
your
comment
due
to
technical
difficulties
or
needs
further
information
on
the
substance
of
your
comment.
EPA's
policy
is
that
EPA
will
not
edit
your
comment,
and
any
identifying
or
contact
information
provided
in
the
body
of
a
comment
will
be
included
as
part
of
the
comment
that
is
placed
in
the
official
public
docket,
and
made
available
in
EPA's
electronic
public
docket.
If
EPA
cannot
read
your
comment
due
to
technical
difficulties
and
cannot
contact
you
for
clarification,
EPA
may
not
be
able
to
consider
your
comment.
i.
EPA
Dockets.
Your
use
of
EPA's
electronic
public
docket
to
submit
comments
to
EPA
electronically
is
EPA's
preferred
method
for
receiving
comments.
Go
directly
to
EPA
Dockets
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67,
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188
/
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September
27,
2002
/
Notices
at
http://
www.
epa.
gov/
edocket,
and
follow
the
online
instructions
for
submitting
comments.
Once
in
the
system,
select
``
search,
''
and
then
key
in
docket
ID
number
OPPÐ
2002Ð
0260.
The
system
is
an
``
anonymous
access''
system,
which
means
EPA
will
not
know
your
identity,
e
mail
address,
or
other
contact
information
unless
you
provide
it
in
the
body
of
your
comment.
ii.
E
mail.
Comments
may
be
sent
by
e
mail
to
opp
docket@
epa.
gov,
Attention:
Docket
ID
Number
OPPÐ
2002Ð
0260.
In
contrast
to
EPA's
electronic
public
docket,
EPA's
e
mail
system
is
not
an
``
anonymous
access''
system.
If
you
send
an
e
mail
comment
directly
to
the
docket
without
going
through
EPA's
electronic
public
docket,
EPA's
e
mail
system
automatically
captures
your
e
mail
address.
E
mail
addresses
that
are
automatically
captured
by
EPA's
e
mail
system
are
included
as
part
of
the
comment
that
is
placed
in
the
official
public
docket,
and
made
available
in
EPA's
electronic
public
docket.
iii.
Disk
or
CD
ROM.
You
may
submit
comments
on
a
disk
or
CD
ROM
that
you
mail
to
the
mailing
address
identified
in
Unit
I.
C.
2.
These
electronic
submissions
will
be
accepted
in
WordPerfect
or
ASCII
file
format.
Avoid
the
use
of
special
characters
and
any
form
of
encryption.
2.
By
mail.
Send
your
comments
to:
Public
Information
and
Records
Integrity
Branch
(PIRIB),
Office
of
Pesticide
Programs
(OPP),
Environmental
Protection
Agency
(7502C),
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460Ð
0001,
Attention:
Docket
ID
Number
OPPÐ
2002Ð
0260.
3.
By
hand
delivery
or
courier.
Deliver
your
comments
to:
Public
Information
and
Records
Integrity
Branch
(PIRIB),
Office
of
Pesticide
Programs
(OPP),
Environmental
Protection
Agency,
Rm.
119,
Crystal
Mall
#2,
1921
Jefferson
Davis
Hwy.,
Arlington,
VA,
Attention:
Docket
ID
Number
OPPÐ
2002Ð
0260.
Such
deliveries
are
only
accepted
during
the
Docket's
normal
hours
of
operation
as
identified
in
Unit
I.
B.
1.
D.
How
Should
I
Submit
CBI
to
the
Agency?
Do
not
submit
information
that
you
consider
to
be
CBI
electronically
through
EPA's
electronic
public
docket
or
by
e
mail.
You
may
claim
information
that
you
submit
to
EPA
as
CBI
by
marking
any
part
or
all
of
that
information
as
CBI
(if
you
submit
CBI
on
disk
or
CD
ROM,
mark
the
outside
of
the
disk
or
CD
ROM
as
CBI
and
then
identify
electronically
within
the
disk
or
CD
ROM
the
specific
information
that
is
CBI).
Information
so
marked
will
not
be
disclosed
except
in
accordance
with
procedures
set
forth
in
40
CFR
part
2.
In
addition
to
one
complete
version
of
the
comment
that
includes
any
information
claimed
as
CBI,
a
copy
of
the
comment
that
does
not
contain
the
information
claimed
as
CBI
must
be
submitted
for
inclusion
in
the
public
docket
and
EPA's
electronic
public
docket.
If
you
submit
the
copy
that
does
not
contain
CBI
on
disk
or
CD
ROM,
mark
the
outside
of
the
disk
or
CD
ROM
clearly
that
it
does
not
contain
CBI.
Information
not
marked
as
CBI
will
be
included
in
the
public
docket
and
EPA's
electronic
public
docket
without
prior
notice.
If
you
have
any
questions
about
CBI
or
the
procedures
for
claiming
CBI,
please
consult
the
person
listed
under
FOR
FURTHER
INFORMATION
CONTACT.
E.
What
Should
I
Consider
as
I
Prepare
My
Comments
for
EPA?
You
may
find
the
following
suggestions
helpful
for
preparing
your
comments:
1.
Explain
your
views
as
clearly
as
possible.
2.
Describe
any
assumptions
that
you
used.
3.
Provide
copies
of
any
technical
information
and/
or
data
you
used
that
support
your
views.
4.
If
you
estimate
potential
burden
or
costs,
explain
how
you
arrived
at
the
estimate
that
you
provide.
5.
Provide
specific
examples
to
illustrate
your
concerns.
6.
Offer
alternative
ways
to
improve
the
notice.
7.
Make
sure
to
submit
your
comments
by
the
deadline
in
this
document.
8.
To
ensure
proper
receipt
by
EPA,
be
sure
to
identify
the
docket
ID
number
assigned
to
this
action
in
the
subject
line
on
the
first
page
of
your
response.
You
may
also
provide
the
name,
date,
and
Federal
Register
citation.
II.
Background
A.
What
Action
is
the
Agency
Taking?
Under
section
18
of
the
Federal
Insecticide,
Fungicide,
and
Rodenticide
Act
(FIFRA)
(7
U.
S.
C.
136p),
at
the
discretion
of
the
Administrator,
a
Federal
or
State
agency
may
be
exempted
from
any
provision
of
FIFRA
if
the
Administrator
determines
that
emergency
conditions
exist
which
require
the
exemption.
The
U.
S.
Department
of
Agriculture,
Animal
and
Plant
Health
Inspection
Service
(USDA,
APHIS)
has
requested
the
Administrator
to
issue
a
quarantine
exemption
for
the
use
of
caffeine
on
floriculture
and
nursery
crops,
parks,
hotels
and
resort
areas,
and
forest
habitats
to
control
Coqui
and
Greenhouse
frogs.
Information
in
accordance
with
40
CFR
part
166
was
submitted
as
part
of
this
request.
As
part
of
this
request,
the
Applicant
asserts
that
it
is
necessary
to
control
the
Coqui
and
Greenhouse
frogs
(Eleutherodactylus
coqui
and
E.
planirostris),
in
areas
of
Hawaii
where
they
have
become
accidentally
introduced,
via
infested
nursery
plantings.
These
species
are
not
native
to
Hawaii,
but
come
from
the
Caribbean,
and
have
the
potential
to
cause
serious
damage
to
the
native
ecosystems,
including
endangered
and
threatened
species.
E.
coqui
is
now
firmly
established
on
Maui
and
the
Island
of
Hawaii
and
E.
planirostris
is
on
Kauai,
Oahu,
Maui,
and
the
Island
of
Hawaii.
The
sites
where
they
are
established
include
commercial
plant
nurseries,
residential
areas,
resorts
and
hotels,
parks,
and
forest
habitats.
Eleutherodactylus
are
spread
to
additional
sites
primarily
through
transportation
of
infested
plant
material
to
uninfested
areas.
There
is
great
concern
that
these
frogs
pose
a
serious
threat
to
both
agriculture
and
the
native
Hawaiian
forest
ecosystems,
including
many
endangered
species.
These
species
may
exert
tremendous
predation
pressure
on
a
wide
variety
of
native
arthropods,
many
of
which
are
already
stressed
to
the
edge
of
extinction
due
to
the
establishment
of
other
alien
predators
and
parasitoids.
Additionally,
these
frog
species
will
compete
for
insect
food
sources
with
native
birds,
the
majority
of
which
are
partially
or
completely
insectivorous.
The
Hawaiian
hoary
bat
and
other
arthropods
also
depend
upon
insects
and
spiders
as
a
food
source.
E.
coqui
tolerates
a
higher
elevational
range,
and
therefore
may
invade
native
rainforest
and
mesic
forests
in
Hawaii.
According
to
Dr.
Fred
Kraus,
Alien
Species
Coordinator
with
the
Hawaii
Department
of
Land
and
Natural
Resources,
Forestry
and
Wildlife
Division,
currently
none
of
the
sites
infested
with
Eleutherodactylus
are
habitats
for
endangered
species.
However,
there
is
a
potential
for
the
frogs
to
enter
these
habitats,
particularly
near
the
Hawaii
Volcanoes
National
Park,
where
the
nearest
infested
area
is
about
2
miles
away.
Another
concern
is
that
increase
in
populations
of
these
frog
species
will
provide
a
food
source
for,
and
enhance,
the
already
large
populations
of
introduced
predators,
such
as
rats
and
mongooses.
In
turn,
this
would
further
increase
predation
pressure
on
native
birds,
a
dynamic
which
has
been
demonstrated
elsewhere
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/
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67,
No.
188
/
Friday,
September
27,
2002
/
Notices
and
suspected
to
occur
for
other
species
in
Hawaii.
The
Applicant
proposes
to
make
up
to
12
applications
per
acre
per
year
of
100
200
pounds
of
product
(99
198
pounds
of
caffeine)
in
1,200
gallons
of
water
per
acre.
However,
a
maximum
of
only
1,200
pounds
of
product
(1,188
pounds
caffeine)
will
be
applied
per
acre
per
year.
The
projected
acreage
for
2002Ð
2003
is
200
acres
of
floriculture
and
nursery
crops,
parks,
hotels
and
resort
areas,
and
forest
habitats
throughout
the
state
of
Hawaii.
Therefore,
a
maximum
of
240,000
pounds
caffeine
could
be
applied.
This
notice
does
not
constitute
a
decision
by
EPA
on
the
application
itself.
The
regulations
governing
section
18
of
FIFRA
require
publication
of
a
notice
of
receipt
of
an
application
for
a
specific
exemption
proposing
use
of
a
new
chemical
(i.
e.,
an
active
ingredient)
which
has
not
been
registered
by
EPA.
The
notice
provides
an
opportunity
for
public
comment
on
the
application.
The
Agency,
will
review
and
consider
all
comments
received
during
the
comment
period
in
determining
whether
to
issue
the
quarantine
exemption
requested
by
the
USDA,
APHIS.
List
of
Subjects
Environmental
protection,
Pesticides
and
pests.
Dated:
September
20,
2002.
Peter
Caulkins,
Acting
Director,
Registration
Division,
Office
of
Pesticide
Programs.
[FR
Doc.
02Ð
24489
Filed
9Ð
26Ð
02;
8:
45
am]
BILLING
CODE
6560–
50–
S
ENVIRONMENTAL
PROTECTION
AGENCY
[OPPT–
2002–
0038;
FRL–
7188–
1]
Lead
Based
Paint
Activities
in
Target
Housing
and
Child
Occupied
Facilities;
State
of
Illinois
Authorization
of
LeadBased
Paint
Activities
Program
AGENCY:
Environmental
Protection
Agency
(EPA).
ACTION:
Notice;
final
approval
of
the
Illinois
TSCA
Section
402/
404
LeadBased
Paint
Accreditation
and
Certification
Program.
SUMMARY:
On
October
12,
2001,
the
State
of
Illinois,
through
the
Illinois
Department
of
Public
Health
(IDPH),
submitted
an
application
for
EPA
final
approval
to
administer
and
enforce
training
and
certification
requirements,
training
program
accreditation
requirements,
and
work
practice
standards
for
lead
based
paint
activities
in
target
housing
and
child
occupied
facilities
under
section
402
of
the
Toxic
Substances
Control
Act
(TSCA).
This
notice
announces
the
approval
of
Illinois'
application,
and
the
authorization
of
the
Illinois
Department
of
Public
Health's
lead
based
paint
program
to
apply
in
the
State
of
Illinois
effective
April
11,
2002,
in
lieu
of
the
Federal
program
under
section
402
of
TSCA.
DATES:
Lead
based
paint
activities
program
authorization
was
granted
to
the
State
of
Illinois
effective
April
11,
2002.
FOR
FURTHER
INFORMATION
CONTACT:
By
mail:
Larisa
Leonova,
State
of
Illinois
Project
Officer,
Pesticides
and
Toxics
Branch,
(DT
8J),
Environmental
Protection
Agency,
Region
V,
77
West
Jackson
Blvd.,
Chicago,
IL
60604;
telephone:
(312)
353Ð
5838;
e
mail
address:
leonova.
larisa@
epamail.
epa.
gov.
SUPPLEMENTARY
INFORMATION:
I.
General
Information
A.
Does
this
Action
Apply
to
Me?
This
action
is
directed
to
the
public
in
general.
This
action
may,
however,
be
of
interest
to
firms
and
individuals
engaged
in
lead
based
paint
activities
in
Illinois.
Since
other
entities
may
also
be
interested,
the
Agency
has
not
attempted
to
describe
all
the
specific
entities
that
may
be
affected
by
this
action.
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
Additional
Information,
Including
Copies
of
this
Document
or
Other
Related
Documents?
1.
Electronically.
You
may
obtain
electronic
copies
of
this
Federal
Register
notice
document,
and
certain
other
related
documents
that
might
be
available
electronically,
from
the
EPA
Internet
Home
Page
at
http://
www.
epa.
gov/.
To
access
this
document,
on
the
Home
Page
select
``
Laws
and
Regulations''
and
then
look
up
the
entry
for
this
document
under
the
``
Federal
RegisterÑ
Environmental
Documents.
''
You
can
also
go
directly
to
the
Federal
Register
listings
at
http://
www.
epa.
gov/
fedrgstr/.
2.
In
person.
The
Agency
has
established
an
official
record
for
this
action
under
docket
ID
number
OPPTÐ
2002Ð
0038.
The
official
record
consists
of
the
documents
specifically
referenced
in
this
action,
this
notice,
the
State
of
Illinois'
authorization
application,
any
public
comments
received
during
an
applicable
comment
period,
and
other
information
related
to
this
action,
including
any
information
claimed
as
Confidential
Business
Information
(CBI).
This
official
record
includes
the
documents
that
are
physically
located
in
the
docket,
as
well
as
the
documents
that
are
referenced
in
those
documents.
The
public
version
of
the
official
record
does
not
include
any
information
claimed
as
CBI.
The
public
version
of
the
official
record,
which
includes
printed,
paper
versions
of
any
electronic
comments
submitted
during
an
applicable
comment
period,
is
available
for
inspection
from
8
a.
m.
to
4:
30
p.
m.,
Monday
through
Friday,
excluding
legal
holidays.
The
docket
is
located
at
the
EPA
Region
V
Office,
Waste,
Pesticides
and
Toxics
Division,
Pesticides
and
Toxics
Branch,
Toxics
Program
Section,
(DT
8J),
77
West
Jackson
Blvd.,
Chicago,
IL
60604.
II.
Background
A.
What
Action
is
the
Agency
Taking?
EPA
issued
correspondence
to
the
Illinois
Department
of
Public
Health
dated
May
6,
1999,
which
granted
a
3Ð
year
interim
approval
of
the
Illinois
Lead
Poisoning
Prevention
Program.
The
interim
approval
authorized
the
Department
to
enforce
the
Illinois
Lead
Poisoning
Prevention
Act
(LPPA),
410
ILCS
45,
and
Lead
Poisoning
Prevention
Code
(LPPC),
77
Ill
Adm.
Code
845,
in
lieu
of
the
Federal
program.
The
effective
date
of
the
interim
approval
was
April
16,
1999
(published
by
EPA
in
the
Federal
Register
of
February
29,
2000
(65
FR
10787)
(FRLÐ
6399Ð
4).
As
a
condition
of
the
interim
approval,
the
Department
was
required
to
submit
a
request
for
full
(final)
approval
of
the
Illinois
Program
at
least
180
days
prior
to
the
expiration
of
the
3Ð
year
interim
approval.
Illinois
applied
for
final
approval
and
authorization
to
enforce
its
Lead
Poisoning
Prevention
Program
on
October
12,
2001.
The
Department
provided
amended
copies
of
the
LPPA,
LPPC,
and
the
program
policies
that
govern
the
administration
of
the
program.
Copies
of
the
correspondence
from
the
Illinois
Attorney
General's
office
indicating
the
inapplicability
of
the
Illinois
Environmental
Audit
Privilege
Law
to
the
Illinois
LPPA
and
EPA's
response
accepting
the
opinion
offered
by
the
Illinois
Attorney
General's
office
were
also
included
with
this
application.
These
materials
resolved
the
only
remaining
issue
dealing
with
the
applicability
of
the
Illinois
Environmental
Audit
Privilege
Law
to
the
enforcement
of
the
LPPA
and
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| epa | 2024-06-07T20:31:43.922008 | regulations | {
"license": "Public Domain",
"url": "https://downloads.regulations.gov/EPA-HQ-OPP-2002-0260-0001/content.txt"
} |
EPA-HQ-OPP-2002-0260-0014 | Notice | "2002-10-17T04:00:00" | Caffeine; Receipt of Application for Emergency Exemption, Solicitation of Public Comment;
Extension of Comment Period | 64113
Federal
Register
/
Vol.
67,
No.
201
/
Thursday,
October
17,
2002
/
Notices
www.
ferc.
gov
using
the
``
RIMS''
link,
select
``
Docket
#''
and
follow
the
instructions
(call
202–
208–
2222
for
assistance).
Protests
and
interventions
may
be
filed
electronically
via
the
Internet
in
lieu
of
paper;
see
18
CFR
385.2001(
a)(
1)(
iii)
and
the
instructions
on
the
Commission's
web
site
under
the
``
e
Filing''
link.
Magalie
R.
Salas,
Secretary.
[FR
Doc.
02–
26363
Filed
10–
15–
02;
8:
45
am]
BILLING
CODE
6717–
01–
P
ENVIRONMENTAL
PROTECTION
AGENCY
[FRL–
7394–
4]
RIN
2040–
AD55
Public
Meetings
on
the
Effluent
Limitations
Guidelines
and
New
Source
Performance
Standards
for
the
Concentrated
Aquatic
Animal
Production
(CAAP)
Point
Source
Category
AGENCY:
U.
S.
Environmental
Protection
Agency
(EPA).
ACTION:
Notice
of
public
meeting.
SUMMARY:
The
Office
of
Science
and
Technology
within
EPA's
Office
of
Water
is
conducting
public
meetings
during
the
comment
period
to
discuss
the
proposed
effluent
limitations
guidelines
and
standards
for
the
CAAP
industry.
EPA
will
sponsor
three
public
meetings
throughout
the
United
States
to
give
everyone
an
opportunity
to
attend.
No
registration
is
required
for
these
meetings.
EPA
will
report
on
the
status
of
the
regulatory
development,
and
the
public
can
ask
questions
and
provide
information
and
ideas
to
the
Agency
on
key
technical,
scientific,
economic,
and
other
issues.
DATES:
The
public
meeting
dates
are:
1.
October
30,
2002,
9
a.
m.
to
12
noon,
Washington,
DC.
2.
November
6,
2002,
9
a.
m.
to
12
noon,
Seattle,
WA.
3.
November
12,
2002,
9
a.
m.
to
12
noon,
Atlanta,
GA.
ADDRESSES:
The
meeting
locations
are:
1.
Washington—
EPA
East
(Room
1153),
1201
Constitution
Avenue,
Washington,
DC
20460.
The
closest
Metro
stop
is
Federal
Triangle.
2.
Seattle—
EPA
Region
10
Building
(Nisqually
Pend
Orielle—
Quinalt—
Shoshone
Conference
Room),
1200
6th
Avenue,
Seattle,
WA
98101.
You
can
find
more
information
on
Seattle
transportation,
directions,
etc.
on
the
following
Web
site:
http://
yosemite.
epa.
gov/
R10/
EXTAFF.
NSF/
webpage/
visiting+
our+
offices?
OpenDocument.
3.
Atlanta—
Sam
Nunn
Atlanta
Federal
Center
(Atlanta
Augusta
Room),
61
Forsyth
St,
SW,
Atlanta,
GA
30303.
You
can
find
more
information
on
Atlanta
hotels,
transportation,
etc.
at
http://
www.
epa.
gov/
region4/
visitors/
transpor1.
htm.
FOR
FURTHER
INFORMATION
CONTACT:
Marta
Jordan,
Engineering
and
Analysis
Division
(4303),
U.
S.
EPA,
1200
Pennsylvania
Ave
NW.,
Washington
DC
20460.
Telephone
(202)
566–
1049,
fax
(202)
566–
1053
or
e
mail
jordan.
marta@
epa.
gov.
SUPPLEMENTARY
INFORMATION:
On
September
12,
2002
(67
FR
57871),
EPA
proposed
effluent
limitations
guidelines
and
standards
for
the
CAAP
Category
under
authority
of
the
Clean
Water
Act
(33
U.
S.
C.
1251
et
seq.).
The
proposed
regulations
would
apply
to
discharges
from
certain
facilities
in
the
CAAP
Category
that
grow,
contain
or
produce
aquatic
animals
at
amounts
above
100,000
pounds
for
three
subcategories:
flow
through,
recirculating
and
net
pen
systems.
EPA
did
not
propose
to
amend
the
National
Pollutant
Discharge
Elimination
System
permitting
regulations
that
define
the
facilities
subject
to
permits.
The
proposed
effluent
guidelines
and
standards
would
apply
to
many,
but
not
all
CAAP
facilities.
The
public
meetings
will
include
a
discussion
of
the
scope
of
the
regulation
(including
subcategorization),
a
summary
of
industry
information,
technology
based
regulatory
options,
and
general
CAAP
industry
issues.
Because
EPA
did
not
propose
pretreatment
standards
for
CAAP
facilities,
meeting
agendas
do
not
include
pretreatment.
Although
EPA
will
not
record
and
transcribe
these
meetings,
EPA
will
prepare
meeting
summaries
and
add
them
to
the
rulemaking
record.
If
you
need
special
accommodations
at
these
meetings,
such
as
wheelchair
access
or
special
audio
visual
needs,
you
should
contact
the
following
at
least
five
business
days
before
the
meeting
so
that
EPA
can
make
appropriate
arrangements:
Marta
Jordan
at
(202)
566–
1049
for
the
meeting
in
Washington,
DC.
Cathe
Bell
at
(206)
553–
0308
and/
or
Margaret/
Maria
(audio
visual
needs)
at
(206)
553–
1050
for
the
meeting
in
Seattle.
You
can
also
use
the
following
Web
site
to
find
information
on
directions,
lodging,
and
transportation:
http://
yosemite.
epa.
gov/
R10/
EXTAFF.
NSF/
webpage/
visiting+
our+
offices?
OpenDocument.
Gary
Hosmer
at
(404)
562–
8151
for
the
meeting
in
Atlanta.
You
can
also
use
the
following
Web
site
to
find
information
on
directions,
lodging,
and
transportation:
http://
www.
epa.
gov/
region4/
visitors/
transpor1.
htm.
Those
who
are
unable
to
attend
the
meeting
can
get
a
copy
of
the
presentation
and
meeting
materials
after
the
meeting
by
making
an
e
mail
or
telephone
request
to
Mrs.
Marta
E.
Jordan,
see
the
FOR
FURTHER
INFORMATION
CONTACT
section
above.
Dated:
October
10,
2002.
Geoffrey
H.
Grubbs,
Director,
Office
of
Science
and
Technology.
[FR
Doc.
02–
26442
Filed
10–
16–
02;
8:
45
am]
BILLING
CODE
6560–
50–
P
ENVIRONMENTAL
PROTECTION
AGENCY
[OPP–
2002–
0260;
FRL–
7278–
4]
Caffeine;
Receipt
of
Application
for
Emergency
Exemption,
Solicitation
of
Public
Comment;
Extension
of
Comment
Period
AGENCY:
Environmental
Protection
Agency
(EPA).
ACTION:
Notice;
extension
of
comment
period.
SUMMARY:
On
September
27,
2002,
EPA
published
a
notice
soliciting
public
comments
regarding
the
receipt
of
an
application
for
a
quarantine
exemption
from
the
United
States
Department
of
Agriculture
Animal
and
Plant
Health
Inspection
Service
(USDA,
APHIS)
to
use
the
pesticide
caffeine
(1H
purine2,6
dione,
3,7
dihydro
1,3,7
trimethyl)
(CAS
No.
58–
08–
2)
to
treat
up
to
200
acres
of
floriculture
and
nursery
crops,
parks,
hotels
and
resort
areas,
and
forest
habitats
to
control
Coqui
and
Greenhouse
frogs.
Comments
were
being
requested
because
the
Applicant
proposes
the
use
of
a
new
chemical
which
has
not
been
registered
by
EPA.
EPA
is
extending
the
comment
period
for
8
days,
from
October
15,
2002,
to
October
23,
2002.
DATES:
Comments,
identified
by
docket
ID
number
OPP–
2002–
0260
must
be
received
on
or
before
October
23,
2002.
ADDRESSES:
Comments
may
be
submitted
electronically,
by
mail,
or
through
hand
delivery/
courier.
Follow
the
detailed
instructions
as
provided
in
Unit
I.
C.
of
the
SUPPLEMENTARY
INFORMATION
of
the
September
27,
2002
Federal
Register
document.
FOR
FURTHER
INFORMATION
CONTACT:
Barbara
Madden,
Registration
Division
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Federal
Register
/
Vol.
67,
No.
201
/
Thursday,
October
17,
2002
/
Notices
(7505C),
Office
of
Pesticide
Programs,
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460–
0001;
telephone
number:
(703)
305–
6463;
fax
number:
(703)
308–
5433;
e
mail
address:
Sec
18
Mailbox@
epamail.
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
a
federal
or
state
government
agency
involved
in
administration
of
environmental
quality
programs.
Potentially
affected
entities
may
include,
but
are
not
limited
to:
Federal
or
state
government
entity,
(NAICS
9241),
e.
g.,
Department
of
Agriculture,
Environment.
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–
0260.
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/.
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.
C.
How
and
to
Whom
Do
I
Submit
Comments?
To
submit
comments,
or
access
the
official
public
docket,
please
follow
the
detailed
instructions
as
provided
in
Unit
I.
C.
of
the
SUPPLEMENTARY
INFORMATION
of
the
September
27,
2002
Federal
Register
document.
If
you
have
questions,
consult
the
person
listed
under
FOR
FURTHER
INFORMATION
CONTACT.
II.
What
Action
is
EPA
taking?
This
document
extends
the
public
comment
period
established
in
the
Federal
Register
of
September
27,
2002
(67
FR
61099)
(FRL–
7275–
2).
In
that
document,
EPA
sought
comment
on
a
quarantine
exemption
request
from
USDA,
APHIS
to
use
the
pesticide
caffeine
(1H
purine
2,6
dione,
3,7
dihydro
1,3,7
trimethyl)
(CAS
No.
58–
08–
2)
to
treat
up
to
200
acres
of
floriculture
and
nursery
crops,
parks,
hotels
and
resort
areas,
and
forest
habitats
to
control
Coqui
and
Greenhouse
frogs.
The
Applicant
proposes
the
use
of
a
new
chemical
which
has
not
been
registered
by
EPA.
EPA
is
hereby
extending
the
comment
period,
which
was
set
to
end
on
October
15,
2002,
to
October
25,
2002.
III.
What
is
the
Agency's
Authority
for
Taking
this
Action?
In
accordance
with
40
CFR
166
the
Administrator
shall
issue
a
notice
of
receipt
for
a
quarantine
exemption
request
when
the
application
proposes
the
use
of
a
new
chemical.
Further
provisions
are
made
to
give
the
public
15
days
to
comment.
However,
the
Administrator
may
extend
the
comment
period
if
additional
time
for
comment
is
requested.
List
of
Subjects
Environmental
protection,
Pesticides
and
pests.
Dated:
October
10,
2002.
Peter
Caulkins,
Acting
Director,
Registration
Division,
Office
of
Pesticide
Programs.
[FR
Doc.
02–
26438
Filed
10–
11–
02;
4:
47
pm]
BILLING
CODE
6560–
50–
S
THE
PRESIDENT'S
CRITICAL
INFRASTRUCTURE
PROTECTION
BOARD
National
Strategy
To
Secure
Cyberspace
October
11,
2002.
AGENCY:
President's
Critical
Infrastructure
Protection
Board,
Executive
Office
Of
the
President,
The
White
House.
ACTION:
Notice
of
pending
request
for
public
comment
regarding
the
National
Strategy
to
Secure
Cyberspace
for
comment,
released
on
September
18,
2002.
SUMMARY:
Pursuant
to
the
President's
charge
in
Executive
Order
12321,
the
President's
Critical
Infrastructure
Protection
Board
(the
``
Board'')
has
been
engaged
in
development
of
the
National
Strategy
to
Secure
Cyberspace.
On
September
18,
2002,
the
Board
released
to
the
public
a
draft
of
the
Strategy
``
For
Comment''
(the
``
Strategy'').
The
Strategy
was
made
available
online
at
http://
www.
securecyberspace.
gov
for
viewing
and
downloading.
At
the
time
of
the
release
of
the
Strategy,
the
Board
invited
public
comments
and
set
a
deadline
of
November
18,
2002
for
such
comments.
The
most
efficient
way
to
provide
public
comment
is
to
do
so
online
through
the
feedback
link
at
http://
www.
securecyberspace.
gov.
By
this
Notice,
the
Board
continues
to
solicit
further
comments
and
views
from
the
public
on
the
Strategy.
DATES:
Comments
may
be
submitted
through
November
18,
2002.
ADDRESSES:
Comments
may
be
submitted
electronically
as
provided
at
http://
www.
securecyberspace.
gov.
In
addition,
written
comments
may
be
sent
to:
PCIPB/
Strategy
Public
Comment;
The
White
House;
Washington,
DC
20502.
Individual
hard
copies
of
the
draft
Strategy
may
be
obtained
by
calling
202–
456–
5420.
FOR
FURTHER
INFORMATION
CONTACT:
Tommy
J.
Cabe,
(202)
456–
5420.
SUPPLEMENTARY
INFORMATION:
On
October
16,
2001,
the
President
created
the
Board
by
Executive
Order
12321.
The
President
noted
that
``[
t]
he
information
technology
revolution
has
changed
the
way
business
is
transacted,
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| epa | 2024-06-07T20:31:43.929535 | regulations | {
"license": "Public Domain",
"url": "https://downloads.regulations.gov/EPA-HQ-OPP-2002-0260-0014/content.txt"
} |
EPA-HQ-OPP-2002-0261-0001 | Notice | "2002-10-11T04:00:00" | Notice of Receipt of Request for Amendments to Delete Uses in Certain Pesticide
Registrations | 63424
Federal
Register
/
Vol.
67,
No.
198
/
Friday,
October
11,
2002
/
Notices
B.
What
is
the
Agency's
Authority
for
Taking
this
Action?
The
legal
authority
for
this
action
falls
under
FIFRA,
as
amended
in
1988
and
1996.
Section
4(
g)(
2)(
A)
of
FIFRA
directs
that,
after
submission
of
all
data
concerning
a
pesticide
active
ingredient,
``
the
Administrator
shall
determine
whether
pesticides
containing
such
active
ingredient
are
eligible
for
reregistration,
''
before
calling
in
product
specific
data
on
individual
enduse
products,
and
either
reregistering
products
or
taking
``
other
appropriate
regulatory
action.
''
List
of
Subjects
Environmental
protection,
Chemicals,
Pesticides
and
pests.
Dated:
September
24,
2002.
Lois
Ann
Rossi,
Director,
Special
Review
and
Reregistration
Division,
Registration
Division,
Office
of
Pesticide
Programs.
[FR
Doc.
02–
25861
Filed
10–
10–
02;
8:
45
am]
BILLING
CODE
6560–
50–
S
ENVIRONMENTAL
PROTECTION
AGENCY
[OPP–
2002–
0261;
FRL–
7275–
9]
Notice
of
Receipt
of
Requests
for
Amendments
to
Delete
Uses
in
Certain
Pesticide
Registrations
AGENCY:
Environmental
Protection
Agency
(EPA).
ACTION:
Notice.
SUMMARY:
In
accordance
with
section
6(
f)(
1)
of
the
Federal
Insecticide,
Fungicide,
and
Rodenticide
Act
(FIFRA),
as
amended,
EPA
is
issuing
a
notice
of
receipt
of
request
for
amendments
by
registrants
to
delete
uses
in
certain
pesticide
registrations.
Section
6(
f)(
1)
of
FIFRA
provides
that
a
registrant
of
a
pesticide
product
may
at
any
time
request
that
any
of
its
pesticide
registrations
be
amended
to
delete
one
or
more
uses.
FIFRA
further
provides
that,
before
acting
on
the
request,
EPA
must
publish
a
notice
of
receipt
of
any
request
on
the
Federal
Register.
DATES:
The
deletions
are
effective
on
April
9,
2003,
or
on
November
12,
2002,
for
products
with
registration
numbers
007401–
00267,
062719–
00081,
and
062719–
84,
unless
the
Agency
receives
a
withdrawal
request
on
or
before
April
9,
2003,
or
on
before
November
12,
2002,
for
products
with
registration
numbers
007401–
00267,
062719–
00081,
and
062719–
00084.
Users
of
these
products
who
desire
continued
use
on
crops
or
sites
being
deleted
should
contact
the
applicable
registrant
on
or
before
dates
given
above.
ADDRESSES:
Withdrawal
requests
may
be
submitted
by
mail,
electronically,
or
in
person.
Please
follow
the
detailed
instructions
for
each
method
as
provided
in
Unit
I.
of
the
SUPPLEMENTARY
INFORMATION.
To
ensure
proper
receipt
by
EPA,
it
is
imperative
that
you
identify
docket
ID
number
OPP–
2002–
0261
in
the
subject
line
on
the
first
page
of
your
response.
FOR
FURTHER
INFORMATION
CONTACT:
By
mail:
James
A.
Hollins,
Office
of
Pesticide
Programs
(7502C),
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460–
0001;
telephone
number:
(703)
305–
5761;
e
mail
address:
hollins.
james@
epa.
gov.
SUPPLEMENTARY
INFORMATION:
I.
General
Information
A.
Does
this
Action
Apply
to
Me?
This
action
is
directed
to
the
public
in
general.
Although
this
action
may
be
of
particular
interest
to
persons
who
produce
or
use
pesticides,
the
Agency
has
not
attempted
to
describe
all
the
specific
entities
that
may
be
affected
by
this
action.
If
you
have
any
questions
regarding
the
information
in
this
notice,
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
ID
number
OPP–
2002–
0261.
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/.
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.
What
Action
is
the
Agency
Taking?
This
notice
announces
receipt
by
the
Agency
of
applications
from
registrants
to
delete
uses
in
certain
pesticide
registrations.
These
registrations
are
listed
in
the
following
Table
1
by
registration
number,
product
name/
active
ingredient,
and
specific
uses
deleted:
TABLE
1.—
REGISTRATIONS
WITH
REQUESTS
FOR
AMENDMENTS
TO
DELETE
USES
IN
CERTAIN
PESTICIDE
REGISTRATIONS
Registration
Number
Product
Name
Active
Ingredient
Delete
from
Label
006959–
00092
Cesso
Fire
Ant
Killer
Piperonyl
butoxide;
tetramethrin;
permethrin,
mixed
cis,
trans
Indoor
uses
and
use
on
outside
surfaces
of
buildings
007401–
00267
Hi
Yield
5%
Malathion
Dust
Malathion
dust
Use
on
corn
062719–
00081
Lontrel
F
Technical
Clopyralid
Residential
turf
062719–
00084
Lontrel
35A
Clopyralid
Residential
turf
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Federal
Register
/
Vol.
67,
No.
198
/
Friday,
October
11,
2002
/
Notices
TABLE
1.—
REGISTRATIONS
WITH
REQUESTS
FOR
AMENDMENTS
TO
DELETE
USES
IN
CERTAIN
PESTICIDE
REGISTRATIONS—
Continued
Registration
Number
Product
Name
Active
Ingredient
Delete
from
Label
062719–
00330
Esteron
638
2,4
Dichlorophenoxyacetic
acid,
2
butoxyethyl
ester
Cereals
underseeded
with
legumes,
orchard
floors
and
sugarcane
Users
of
these
products
who
desire
continued
use
on
crops
or
sites
being
deleted
should
contact
the
applicable
registrant
before
dates
indicated
in
DATES
section
of
this
notice
to
discuss
withdrawal
of
the
application
for
amendment.
This
180–
day
period,
or
30–
day
where
indicated,
will
also
permit
interested
members
of
the
public
to
intercede
with
registrants
prior
to
the
Agency's
approval
of
the
deletion.
Table
2
includes
the
names
and
addresses
of
record
for
all
registrants
of
the
products
in
Table
1,
in
sequence
by
EPA
company
number.
TABLE
2.—
REGISTRANTS
REQUESTING
AMENDMENTS
TO
DELETE
USES
IN
CERTAIN
PESTICIDE
REGISTRATIONS
EPA
Company
Number
Company
Name
and
Address
006959
Cessco
Inc.
3609A
River
Road
Johns
Island,
SC
29455
007401
Brazos
Associates
Inc.
Agent
For:
Voluntary
Purchasing
Group
Inc.
2001
Diamond
Ridge
Drive
Carrollton,
TX
75010
062719
Dow
Agrosciences
LLC.
9330
Zionsville
Road
308/
2E225
Indianapolis,
IN
46268
III.
What
is
the
Agency
Authority
for
Taking
This
Action?
Section
6(
f)(
1)
of
FIFRA
provides
that
a
registrant
of
a
pesticide
product
may
at
any
time
request
that
any
of
its
pesticide
registrations
be
amended
to
delete
one
or
more
uses.
The
Act
further
provides
that,
before
acting
on
the
request,
EPA
must
publish
a
notice
of
receipt
of
any
such
request
in
the
Federal
Register.
Thereafter,
the
Administrator
may
approve
such
a
request.
IV.
Procedures
for
Withdrawal
of
Request
Registrants
who
choose
to
withdraw
a
request
for
use
deletion
must
submit
such
withdrawal
in
writing
to
James
A.
Hollins,
at
the
address
under
FOR
FURTHER
INFORMATION
CONTACT,
postmarked
on
or
before
April
9,
2003,
or
on
or
before
November
12,
2002,
for
products
with
registration
numbers
007401–
00267,
062719–
00081,
and
062719–
00084.
V.
Provisions
for
Disposition
of
Existing
Stocks
The
Agency
has
authorized
the
registrants
to
sell
or
distribute
product
under
the
previously
approved
labeling
for
a
period
of
18
months
after
approval
of
the
revision,
unless
other
restrictions
have
been
imposed,
as
in
special
review
actions.
There
is
a
12–
month
existing
stocks
provision
for
Dow
AgroSciences,
EPA
registration
numbers
062719–
00081,
and
062719–
00084,
after
approval
of
revised
label.
List
of
Subjects
Environmental
protection,
Pesticides
and
pests.
Dated:
September
23,
2002.
Linda
Vlier
Moos,
Acting
Director,
Information
Resources
and
Services
Division,
Office
of
Pesticide
Programs.
[FR
Doc.
02–
25423
Filed
10–
10–
02;
8:
45
am]
BILLING
CODE
6560–
50–
S
OFFICE
OF
NATIONAL
DRUG
CONTROL
POLICY
Appointment
of
Members
of
Senior
Executive
Services
Performance
Review
Board
AGENCY:
Office
of
National
Drug
Control
Policy
(ONDCP).
ACTION:
Notice
of
Appointments.
SUMMARY:
The
following
persons
have
been
appointed
to
the
ONDCP
Senior
Executive
Service
Performance
Review
Board:
Dr.
Albert
E.
Brandenstein;
Mr.
Robert
Brown;
Mr.
Norman
R.
Deck;
and
Mr.
Edward
H.
Jurith.
FOR
FURTHER
INFORMATION
CONTACT:
Please
direct
any
questions
to
Linda
V.
Priebe,
Assistant
General
Counsel
(202)
395–
6622,
Office
of
National
Drug
Control
Policy,
Executive
Office
of
the
President,
Washington,
DC
20503.
Linda
V.
Priebe,
Assistant
General
Counsel.
[FR
Doc.
02–
25933
Filed
10–
10–
02;
8:
45
am]
BILLING
CODE
3180–
02–
M
FEDERAL
EMERGENCY
MANAGEMENT
AGENCY
[FEMA–
1435–
DR]
Louisiana;
Major
Disaster
and
Related
Determinations
AGENCY:
Federal
Emergency
Management
Agency
(FEMA).
ACTION:
Notice.
SUMMARY:
This
is
a
notice
of
the
Presidential
declaration
of
a
major
disaster
for
the
State
of
Louisiana
(FEMA–
1435–
DR),
dated
September
27,
2002,
and
related
determinations.
EFFECTIVE
DATE:
September
27,
2002.
FOR
FURTHER
INFORMATION
CONTACT:
Magda
Ruiz,
Response
and
Recovery
Directorate,
Federal
Emergency
Management
Agency,
Washington,
DC
20472,
(202)
646–
2705
or
Magda.
Ruiz@
fema.
gov.
SUPPLEMENTARY
INFORMATION:
Notice
is
hereby
given
that,
in
a
letter
dated
September
27,
2002,
the
President
declared
a
major
disaster
under
the
authority
of
the
Robert
T.
Stafford
Disaster
Relief
and
Emergency
Assistance
Act,
42
U.
S.
C.
5121–
5206
(Stafford
Act),
as
follows:
I
have
determined
that
the
damage
in
certain
areas
of
the
State
of
Louisiana,
resulting
from
Tropical
Storm
Isidore
beginning
on
September
21,
2002,
and
continuing
is
of
sufficient
severity
and
magnitude
to
warrant
a
major
disaster
declaration
under
the
Robert
T.
Stafford
Disaster
Relief
and
Emergency
Assistance
Act,
42
U.
S.
C.
5121–
5206
(Stafford
Act).
I,
therefore,
declare
that
such
a
major
disaster
exists
in
the
State
of
Louisiana.
In
order
to
provide
Federal
assistance,
you
are
hereby
authorized
to
allocate
from
funds
available
for
these
purposes,
such
amounts
as
you
find
necessary
for
Federal
disaster
assistance
and
administrative
expenses.
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| epa | 2024-06-07T20:31:43.932775 | regulations | {
"license": "Public Domain",
"url": "https://downloads.regulations.gov/EPA-HQ-OPP-2002-0261-0001/content.txt"
} |
EPA-HQ-OPP-2002-0262-0001 | Notice | "2002-11-06T05:00:00" | Endosulfan; Availability of the Reregistration Eligibility Decision Documents for Comment | 67617
Federal
Register
/
Vol.
67,
No.
215
/
Wednesday,
November
6,
2002
/
Notices
Guidelines
is
an
appropriate
step
in
effectively
implementing
SBLRBRA.
All
written
comments
must
be
received
by
the
Agency
no
later
than
seven
calendar
days
from
federal
notice
publication.
The
Agency
will
carefully
consider
written
comments
received
during
the
public
comment
period,
prior
to
issuing
final
Brownfields
Job
Training
Grant
Application
Guidelines
in
November,
2002.
2002.
However,
due
to
the
need
to
promptly
provide
the
final
FY
03
Job
Training
Guidelines
to
potential
applicants,
EPA
does
not
plan
to
respond
in
writing
to
written
comments.
Dated:
October
24,
2002.
Linda
Garczynski,
Director,
Office
of
Brownfields
Cleanup
and
Redevelopment,
Office
of
Solid
Waste
and
Emergency
Response.
[
FR
Doc.
02
28211
Filed
11
5
02;
8:
45
am]
BILLING
CODE
6560
50
M
ENVIRONMENTAL
PROTECTION
AGENCY
[
OPP
2002
0262;
FRL
7275
5]
Endosulfan;
Availability
of
Reregistration
Eligibility
Decision
Documents
for
Comment
AGENCY:
Environmental
Protection
Agency
(
EPA).
ACTION:
Notice.
SUMMARY:
This
notice
announces
availability
and
starts
a
60
day
public
comment
period
on
the
Reregistration
Eligibility
Decision
(
RED)
document
for
the
pesticide
active
ingredient
endosulfan.
The
RED
represents
EPA's
formal
regulatory
assessment
of
the
health
and
environmental
database
of
the
subject
chemical
and
presents
the
Agency's
determination
regarding
which
pesticidal
uses
are
eligible
for
reregistration.
DATES:
Comments,
identified
by
docket
ID
number
OPP
2002
0262,
must
be
received
on
or
before
January
6,
2003.
ADDRESSES:
Comments
may
be
submitted
electronically,
by
mail,
or
through
hand
delivery/
courier.
Follow
the
detailed
instructions
as
provided
in
Unit
I.
of
the
SUPPLEMENTARY
INFORMATION.
FOR
FURTHER
INFORMATION
CONTACT:
Stacey
Milan,
Chemical
Review
Manager,
Special
Review
and
Reregistration
Division
(
7508C),
Office
of
Pesticide
Programs,
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460
0001;
telephone
number:
(
703)
305
2505;
e
mail
address:
milan.
stacey@
epa.
gov.
SUPPLEMENTARY
INFORMATION:
I.
General
Information
A.
Does
this
Action
Apply
to
Me?
This
action
is
directed
to
the
public
in
general.
This
action
may,
however,
be
of
interest
to
persons
who
are
or
may
be
required
to
conduct
testing
of
chemical
substances
under
the
Federal
Insecticide,
Fungicide,
and
Rodenticide
Act
(
FIFRA)
or
the
Federal
Food,
Drug,
and
Cosmetic
Act
(
FFDCA);
environmental,
human
health,
and
agricultural
advocates;
pesticides
users;
and
members
of
the
public
interested
in
the
use
of
pesticides.
Since
other
entities
may
also
be
interested,
the
Agency
has
not
attempted
to
describe
all
the
specific
entities
that
may
be
affected
by
this
action.
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
0262.
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/.
To
access
RED
documents
and
RED
fact
sheets
electronically,
go
directly
to
the
REDs
table
on
the
EPA
Office
of
Pesticide
Programs
Home
Page,
at
http://
www.
epa.
gov/
pesticides/
reregistration/
status.
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.
Certain
types
of
information
will
not
be
placed
in
the
EPA
Dockets.
Information
claimed
as
CBI
and
other
information
whose
disclosure
is
restricted
by
statute,
which
is
not
included
in
the
official
public
docket,
will
not
be
available
for
public
viewing
in
EPA's
electronic
public
docket.
EPA's
policy
is
that
copyrighted
material
will
not
be
placed
in
EPA's
electronic
public
docket
but
will
be
available
only
in
printed,
paper
form
in
the
official
public
docket.
To
the
extent
feasible,
publicly
available
docket
materials
will
be
made
available
in
EPA's
electronic
public
docket.
When
a
document
is
selected
from
the
index
list
in
EPA
Dockets,
the
system
will
identify
whether
the
document
is
available
for
viewing
in
EPA's
electronic
public
docket.
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.
EPA
intends
to
work
towards
providing
electronic
access
to
all
of
the
publicly
available
docket
materials
through
EPA's
electronic
public
docket.
For
public
commenters,
it
is
important
to
note
that
EPA's
policy
is
that
public
comments,
whether
submitted
electronically
or
in
paper,
will
be
made
available
for
public
viewing
in
EPA's
electronic
public
docket
as
EPA
receives
them
and
without
change,
unless
the
comment
contains
copyrighted
material,
CBI,
or
other
information
whose
disclosure
is
restricted
by
statute.
When
EPA
identifies
a
comment
containing
copyrighted
material,
EPA
will
provide
a
reference
to
that
material
in
the
version
of
the
comment
that
is
placed
in
EPA's
electronic
public
docket.
The
entire
printed
comment,
including
the
copyrighted
material,
will
be
available
in
the
public
docket.
Public
comments
submitted
on
computer
disks
that
are
mailed
or
delivered
to
the
docket
will
be
transferred
to
EPA's
electronic
public
docket.
Public
comments
that
are
mailed
or
delivered
to
the
docket
will
be
scanned
and
placed
in
EPA's
electronic
public
docket.
Where
practical,
physical
objects
will
be
photographed,
and
the
photograph
will
be
placed
in
EPA's
electronic
public
docket
along
with
a
brief
description
written
by
the
docket
staff.
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16:
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Federal
Register
/
Vol.
67,
No.
215
/
Wednesday,
November
6,
2002
/
Notices
C.
How
and
To
Whom
Do
I
Submit
Comments?
You
may
submit
comments
electronically,
by
mail,
or
through
hand
delivery/
courier.
To
ensure
proper
receipt
by
EPA,
identify
the
appropriate
docket
ID
number
in
the
subject
line
on
the
first
page
of
your
comment.
Please
ensure
that
your
comments
are
submitted
within
the
specified
comment
period.
Comments
received
after
the
close
of
the
comment
period
will
be
marked
``
late.''
EPA
is
not
required
to
consider
these
late
comments.
If
you
wish
to
submit
CBI
or
information
that
is
otherwise
protected
by
statute,
please
follow
the
instructions
in
Unit
I.
D.
Do
not
use
EPA
Dockets
or
e
mail
to
submit
CBI
or
information
protected
by
statute.
1.
Electronically.
If
you
submit
an
electronic
comment
as
prescribed
in
this
unit,
EPA
recommends
that
you
include
your
name,
mailing
address,
and
an
email
address
or
other
contact
information
in
the
body
of
your
comment.
Also
include
this
contact
information
on
the
outside
of
any
disk
or
CD
ROM
you
submit,
and
in
any
cover
letter
accompanying
the
disk
or
CD
ROM.
This
ensures
that
you
can
be
identified
as
the
submitter
of
the
comment
and
allows
EPA
to
contact
you
in
case
EPA
cannot
read
your
comment
due
to
technical
difficulties
or
needs
further
information
on
the
substance
of
your
comment.
EPA's
policy
is
that
EPA
will
not
edit
your
comment,
and
any
identifying
or
contact
information
provided
in
the
body
of
a
comment
will
be
included
as
part
of
the
comment
that
is
placed
in
the
official
public
docket,
and
made
available
in
EPA's
electronic
public
docket.
If
EPA
cannot
read
your
comment
due
to
technical
difficulties
and
cannot
contact
you
for
clarification,
EPA
may
not
be
able
to
consider
your
comment.
i.
EPA
Dockets.
Your
use
of
EPA's
electronic
public
docket
to
submit
comments
to
EPA
electronically
is
EPA's
preferred
method
for
receiving
comments.
Go
directly
to
EPA
Dockets
at
http://
www.
epa.
gov/
edocket,
and
follow
the
online
instructions
for
submitting
comments.
Once
in
the
system,
select
``
search,''
and
then
key
in
docket
ID
number
OPP
2002
0262.
The
system
is
an
``
anonymous
access''
system,
which
means
EPA
will
not
know
your
identity,
e
mail
address,
or
other
contact
information
unless
you
provide
it
in
the
body
of
your
comment.
ii.
E
mail.
Comments
may
be
sent
by
e
mail
to
opp
docket@
epa.
gov,
Attention:
Docket
ID
Number
OPP
2002
0262.
In
contrast
to
EPA's
electronic
public
docket,
EPA's
e
mail
system
is
not
an
``
anonymous
access''
system.
If
you
send
an
e
mail
comment
directly
to
the
docket
without
going
through
EPA's
electronic
public
docket,
EPA's
e
mail
system
automatically
captures
your
e
mail
address.
E
mail
addresses
that
are
automatically
captured
by
EPA's
e
mail
system
are
included
as
part
of
the
comment
that
is
placed
in
the
official
public
docket,
and
made
available
in
EPA's
electronic
public
docket.
iii.
Disk
or
CD
ROM.
You
may
submit
comments
on
a
disk
or
CD
ROM
that
you
mail
to
the
mailing
address
identified
in
Unit
I.
C.
2.
These
electronic
submissions
will
be
accepted
in
WordPerfect
or
ASCII
file
format.
Avoid
the
use
of
special
characters
and
any
form
of
encryption.
2.
By
mail.
Send
your
comments
to:
Public
Information
and
Records
Integrity
Branch
(
PIRIB)
(
7502C),
Office
of
Pesticide
Programs
(
OPP),
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460
0001,
Attention:
Docket
ID
Number
OPP
2002
0262.
3.
By
hand
delivery
or
courier.
Deliver
your
comments
to:
Public
Information
and
Records
Integrity
Branch
(
PIRIB),
Office
of
Pesticide
Programs
(
OPP),
Environmental
Protection
Agency,
Rm.
119,
Crystal
Mall
#
2,
1921
Jefferson
Davis
Hwy.,
Arlington,
VA,
Attention:
Docket
ID
Number
OPP
2002
0262.
Such
deliveries
are
only
accepted
during
the
docket's
normal
hours
of
operation
as
identified
in
Unit
I.
B.
1.
D.
How
Should
I
Submit
CBI
to
the
Agency?
Do
not
submit
information
that
you
consider
to
be
CBI
electronically
through
EPA's
electronic
public
docket
or
by
e
mail.
You
may
claim
information
that
you
submit
to
EPA
as
CBI
by
marking
any
part
or
all
of
that
information
as
CBI
(
if
you
submit
CBI
on
disk
or
CD
ROM,
mark
the
outside
of
the
disk
or
CD
ROM
as
CBI
and
then
identify
electronically
within
the
disk
or
CD
ROM
the
specific
information
that
is
CBI).
Information
so
marked
will
not
be
disclosed
except
in
accordance
with
procedures
set
forth
in
40
CFR
part
2.
In
addition
to
one
complete
version
of
the
comment
that
includes
any
information
claimed
as
CBI,
a
copy
of
the
comment
that
does
not
contain
the
information
claimed
as
CBI
must
be
submitted
for
inclusion
in
the
public
docket
and
EPA's
electronic
public
docket.
If
you
submit
the
copy
that
does
not
contain
CBI
on
disk
or
CD
ROM,
mark
the
outside
of
the
disk
or
CD
ROM
clearly
that
it
does
not
contain
CBI.
Information
not
marked
as
CBI
will
be
included
in
the
public
docket
and
EPA's
electronic
public
docket
without
prior
notice.
If
you
have
any
questions
about
CBI
or
the
procedures
for
claiming
CBI,
please
consult
the
person
listed
under
FOR
FURTHER
INFORMATION
CONTACT.
E.
What
Should
I
Consider
as
I
Prepare
My
Comments
for
EPA?
You
may
find
the
following
suggestions
helpful
for
preparing
your
comments:
1.
Explain
your
views
as
clearly
as
possible.
2.
Describe
any
assumptions
that
you
used.
3.
Provide
copies
of
any
technical
information
and/
or
data
you
used
that
support
your
views.
4.
If
you
estimate
potential
burden
or
costs,
explain
how
you
arrived
at
the
estimate
that
you
provide.
5.
Provide
specific
examples
to
illustrate
your
concerns.
6.
Offer
alternative
ways
to
improve
the
notice
or
collection
activity.
7.
Make
sure
to
submit
your
comments
by
the
deadline
in
this
document.
8.
To
ensure
proper
receipt
by
EPA,
be
sure
to
identify
the
docket
ID
number
assigned
to
this
action
in
the
subject
line
on
the
first
page
of
your
response.
You
may
also
provide
the
name,
date,
and
Federal
Register
citation.
II.
Background
A.
What
Action
Is
the
Agency
Taking?
The
Agency
has
issued
a
RED
for
the
pesticide
active
ingredient
endosulfan.
Under
the
Federal
Insecticide,
Fungicide,
and
Rodenticide
Act
(
FIFRA),
as
amended
in
1988,
EPA
is
conducting
an
accelerated
reregistration
program
to
reevaluate
existing
pesticides
to
make
sure
they
meet
current
scientific
and
regulatory
standards.
The
database
to
support
the
reregistration
of
endosulfan
is
substantially
complete,
and
the
Agency
has
identified
risk
mitigation
measures
that
if
adopted
by
the
registrants
will
address
the
human
health
and
ecological
risks
associated
with
the
current
uses
of
endosulfan.
Additional
mitigation
measures
for
ecological
risk
may
be
warranted
following
the
completion
of
a
stakeholder
process,
which
will
be
conducted
to
address
environmental
risks
to
especially
vulnerable
aquatic
organisms.
In
addition,
EPA
is
reevaluating
existing
pesticides
and
reassessing
tolerances
under
the
Food
Quality
Protection
Act
(
FQPA)
of
1996.
The
tolerances
for
those
food
uses
that
will
remain,
following
mitigation
identified
in
the
RED,
have
been
found
to
meet
the
FQPA
Safety
Standard.
All
registrants
of
pesticide
products
containing
endosulfan
will
be
sent
the
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67619
Federal
Register
/
Vol.
67,
No.
215
/
Wednesday,
November
6,
2002
/
Notices
appropriate
RED,
and
in
order
to
be
reregistered,
the
risk
concerns
identified
in
the
RED
must
be
adequately
addressed,
including
appropriate
labeling
changes.
Further,
the
registrants
must
comply
with
product
specific
label
requirements
pending
Office
of
Management
and
Budget
(
OMB)
approval
of
the
endosulfan
Data
Call
In.
The
reregistration
program
is
being
conducted
under
Congressionally
mandated
timeframes,
and
EPA
recognizes
the
need
both
to
make
timely
reregistration
decisions
and
to
involve
the
public.
Therefore,
EPA
is
issuing
the
endosulfan
RED
as
a
final
document
with
a
60
day
comment
period.
Although
the
60
day
public
comment
period
does
not
affect
the
registrant's
response
due
date,
it
is
intended
to
provide
an
opportunity
for
public
input
and
a
mechanism
for
identifying
any
necessary
amendments
to
the
RED.
All
comments
will
be
carefully
considered
by
the
Agency.
If
any
comment
significantly
affects
the
endosulfan
RED,
EPA
will
amend
the
RED
by
publishing
the
amendment
in
the
Federal
Register.
B.
What
is
the
Agency's
Authority
for
Taking
this
Action?
The
legal
authority
for
this
RED
falls
under
FIFRA,
as
amended
in
1988
and
1996.
Section
4(
g)(
2)(
A)
of
FIFRA
directs
that,
after
submission
of
all
data
concerning
a
pesticide
active
ingredient,
``
the
Administrator
shall
determine
whether
pesticides
containing
such
active
ingredient
are
eligible
for
reregistration,''
before
calling
in
product
specific
data
on
individual
end
use
products,
and
either
reregistering
products
or
taking
``
other
appropriate
regulatory
action.''
List
of
Subjects
Environmental
protection,
Chemicals,
Pesticides
and
pests.
Dated:
October
30,
2002.
Betty
Shackleford,
Acting
Director,
Special
Review
and
Reregistration
Division,
Office
of
Pesticide
Programs.
[
FR
Doc.
02
28216
Filed
11
5
02;
8:
45
am]
BILLING
CODE
6560
50
S
ENVIRONMENTAL
PROTECTION
AGENCY
[
FRL
7404
9]
Koppers
Charleston
Superfund
Site;
Notice
To
Rescind
Federal
Register
Notice
Dated
October
1,
2002
AGENCY:
Environmental
Protection
Agency.
ACTION:
Notice
to
rescind
previous
Federal
Register
notice.
SUMMARY:
On
October
1,
2002
at
67
FR
61624,
the
Environmental
Protection
Agency
(
EPA)
published
a
Notice
of
Proposed
Settlement
for
response
costs
incurred
by
EPA
at
the
Koppers
Charleston
Superfund
Site
located
in
Charleston,
Charleston
County,
South
Carolina.
That
notice
was
published
prematurely.
The
purpose
of
this
notice
is
to
rescind
EPA's
October
1,
2002
Federal
Register
Notice
regarding
the
settlement
of
response
costs
at
the
Site.
The
Notice
of
Proposed
Settlement
for
the
Site
may
be
republished
in
the
future
following
final
approval
of
the
settlement.
FOR
FURTHER
INFORMATION
CONTACT:
Paula
Batchelor
at
404
562
8887.
Dated:
October
23,
2002.
Anita
L.
Davis,
Acting
Chief,
CERCLA
Program
Services
Branch,
Waste
Management
Division.
[
FR
Doc.
02
28214
Filed
11
5
02;
8:
45
am]
BILLING
CODE
6560
50
P
FEDERAL
COMMUNICATIONS
COMMISSION
[
WC
Docket
No.
02
214;
FCC
02
297]
Application
by
Verizon
Virginia
Inc.,
Verizon
Long
Distance
Virginia,
Inc.,
Verizon
Enterprise
Solutions
Virginia
Inc.,
Verizon
Global
Networks
Inc.,
and
Verizon
Select
Services
of
Virginia
Inc.,
Pursuant
to
Section
271
of
the
Telecommunications
Act
of
1996,
For
Provision
of
In
Region,
InterLATA
Services
in
the
State
of
Virginia
AGENCY:
Federal
Communications
Commission.
ACTION:
Notice.
SUMMARY:
In
this
document,
the
Federal
Communications
Commission
grants
the
section
271
application
of
Verizon
Virginia
Inc.,
et
al.
(
Verizon)
for
authority
to
enter
the
interLATA
telecommunications
market
in
the
state
of
Virginia.
The
Commission
grants
Verizon's
application
based
on
its
conclusion
that
Verizon
has
satisfied
all
of
the
statutory
requirements
for
entry,
and
opened
its
local
exchange
markets
to
full
competition.
DATES:
Effective
November
8,
2002.
FOR
FURTHER
INFORMATION
CONTACT:
Uzoma
Onyeije,
Attorney
Advisor,
Wireline
Competition
Bureau,
at
(
202)
418
7827
or
via
the
Internet
at
uonyeije@
fcc.
gov.
The
complete
text
of
this
Memorandum
Opinion
and
Order
is
available
for
inspection
and
copying
during
normal
business
hours
in
the
FCC
Reference
Information
Center,
Portals
II,
445
12th
Street,
SW,
Room
CY
A257,
Washington,
DC
20554.
Further
information
may
also
be
obtained
by
calling
the
Common
Carrier
Bureau's
TTY
number:
(
202)
418
0484.
SUPPLEMENTARY
INFORMATION:
This
is
a
summary
of
the
Commission's
Memorandum
Opinion
and
Order
(
MO&
O)
in
WC
Docket
No.
02
214,
FCC
02
297,
adopted
October
30,
2002,
and
released
October
30,
2002.
This
full
text
may
be
purchased
from
the
Commission's
duplicating
contractor,
Qualex
International,
Portals
II,
445
12th
Street,
SW,
Room
CY
B402,
Washington,
DC
20554,
telephone
202
863
2893,
facsimile
202
863
2898,
or
via
e
mail
qualexint@
aol.
com.
It
is
also
available
on
the
Commission's
website
at
http://
www.
fcc.
gov/
Bureaus/
Wireline_
Competition/
in
region
applications.
Synopsis
of
the
Order
1.
History
of
the
Application.
On
August
1,
2002,
Verizon
filed
an
application
pursuant
to
section
271
of
the
Telecommunications
Act
of
1996,
with
the
Commission
to
provide
inregion
interLATA
service
originating
in
the
state
of
Virginia.
Interested
parties
filed
comments
on
August
21,
2002,
and
reply
comments
on
September
12,
2002.
2.
The
State
Commission's
Evaluation.
On
March
15,
2002,
Verizon
made
a
compliance
filing
for
section
271
approval
with
the
Virginia
Commission.
On
July
12,
2002,
the
Virginia
Hearing
Examiner
issued
a
report
recommending
that
the
Virginia
Commission
``
advise
the
FCC
that
this
Commission
supports
granting
Verizon
authority
to
provide
in
region
interLATA
services
in
Virginia.''
On
August
1,
2002,
the
Virginia
Commission
forwarded
the
Virginia
Hearing
Examiner's
Report
to
this
Commission,
reporting
on
the
Virginia
Hearing
Examiner's
section
271
proceeding
and
urging
the
Commission
to
consider
his
recommendations
and
findings.
3.
The
Department
of
Justice's
Evaluation.
The
Department
of
Justice
filed
its
evaluation
on
September
5,
2002,
concluding
that
Verizon
has
generally
succeeded
in
opening
its
markets
to
competition
in
most
respects.
Accordingly,
the
Department
of
Justice
recommends
approval
of
Verizon's
application
for
section
271
authority
in
Virginia.
4.
Compliance
with
Section
271(
c)(
1)(
A).
The
Commission
concludes
that
Verizon
demonstrates
that
it
satisfies
the
requirements
of
section
271(
c)(
1)(
A)
based
on
the
interconnection
agreements
it
has
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| epa | 2024-06-07T20:31:43.936172 | regulations | {
"license": "Public Domain",
"url": "https://downloads.regulations.gov/EPA-HQ-OPP-2002-0262-0001/content.txt"
} |
EPA-HQ-OPP-2002-0262-0003 | Supporting & Related Material | "2002-09-17T04:00:00" | null | UNITED
STATES
ENVIRONMENTAL
PROTECTION
AGENCY
WASHINGTON,
D.
C.
20460
OFFICE
OF
PREVENTION,
PESTICIDES
AND
TOXIC
SUBSTANCES
January
18,
2002
MEMORANDUM
SUBJECT:
RESPONSE
TO
COMMENTS.
Response
to
Comments
on
EPA's
Human
Health
Risk
Assessment
of
Endosulfan
01/
31/
01.
PC
Code:
079401,
Case
#
819236,
DP
Barcode
D279252.
FROM:
Diana
Locke,
Ph.
D.
Toxicologist
Reregistration
Branch
II
Health
Effects
Division
(7509C)
THRU:
Alan
Nielsen,
Branch
Senior
Scientist
Reregistration
Branch
II
Health
Effects
Division
(7509C)
TO:
Dan
Helfgott,
Acting
Chief
Reregistration
Branch
II
Special
Review
and
Reregistration
Division
(7508W)
The
attached
document
titled,
"HED's
Response
to
Comments
for
Endosulfan,"
was
generated
in
Phase
4
of
the
Proposed
Public
Participation
Process
(FR
Notice
03/
15/
00)
to
address
comments
submitted
by
the
Endosulfan
Task
Force
(Aventis
CropScience
USA
LP,
FMC
Corporation,
and
Makhteshim
Agan
of
North
America,
Inc.),
the
Natural
Resources
Defense
Council
(NRDC),
the
Farmworker
Justice
Fund,
Inc.,
the
Institute
for
Agriculture
and
Trade
Policy,
the
Pesticide
Action
Network
North
America
(PANNA)
and
their
affiliate,
the
Pesticide
Action
Network
Asia
and
Pacific
(PANAP),
Respiratory
and
Environmental
Disabilities
Association
of
Hawaii,
and
the
Rural
Action
Safe
Pest
Control
Program
(RASPCP)
to
the
Agency
during
Phase
3
concerning
the
Agency's
Human
Health
Risk
Assessment
of
Endosulfan
01/
31/
01.
The
attached
document
is
the
Agency's
response
to
those
comments.
This
response
includes
input
from
John
Punzi
(Residue
Chemistry),
Sherrie
Kinard
(Dietary
Assessment)
Robert
Fricke
(Toxicology),
Elizabeth
Mendez
(Toxicology),
Renee
Sandvig
(Occupational
and
Residential
Exposure),
Ruth
Allen
(Incident
Data),
and
Diana
Locke
(Risk
Assessment).
cc:
Stacey
Milan
Margaret
Stasikowski
Lois
Rossi
Pauline
Wagner
TABLE
OF
CONTENTS
I.
Introduction
.............................................................
1
II.
ResidueChemistry........................................................
1
III.
Dietary
(Food)
Assessment
.................................................
4
IV.
DrinkingWater..........................................................
4
V.
Toxicology
.............................................................
4
VI.
OccupationalExposure....................................................
7
VII.
IncidentData
.........................................................
10
1
January
18,
2002
HED'S
RESPONSE
TO
COMMENTS
FOR
ENDOSULFAN
I.
Introduction
The
following
is
the
Health
Effects
Division's
(HED)
response
to
comments
(Phase
4)
for
endosulfan,
generated
in
response
to
the
comments
submitted
to
the
public
docket
by
the
Endosulfan
Task
Force
(ETF),
environmental
interests,
and
consumer
concerns
groups
in
Phase
3
of
the
Proposed
Public
Participation
Process.
Some
of
the
responses
serve
as
clarification
or
a
restatement
of
Agency
policies
and
guidance
and
it
is
hoped
that
this
will
provide
a
greater
understanding
of
the
Agency's
position
and
procedures
on
these
matters.
During
Phase
3,
HED's
endosulfan
risk
assessment
document
was
placed
in
the
public
docket
and
all
interested
parties
were
given
60
days
to
comment
to
the
Agency
in
writing.
Comments
concerning
the
rationale
behind
Agency
decisions,
endpoints
selected,
exposure
assessment,
and
interpretation
of
available
data,
were
submitted.
Since
there
were
a
number
of
comments
submitted
from
very
differing
sources,
HED's
responses
will
be
directed
to
the
issues
raised
and
not
to
each
of
the
commentors.
In
many
cases,
the
same
subject
matter
was
raised
by
several
of
the
commentors
but
with
very
different
view
points.
Several
issues
related
to
the
quantitative
risk
assessment
and
characterization
cannot
be
dealt
with
in
the
Phase
4
timeframe.
Emerging
Agency
policy
on
these
issues
is
expected
to
impact
the
risk
assessment
and
will
be
incorporated
into
a
revised
risk
assessment
document
in
the
Spring
of
2002.
During
Phase
3,
the
ETF
submitted
new
data
and
information
that
may
also
impact
the
quantitative
risk
assessment.
These
data/
information
are
being
reviewed
and
will
be
included,
where
appropriate,
in
the
revised
risk
assessment
(Spring
2002).
II.
Residue
Chemistry
The
reregistration
requirements
for
magnitude
of
the
residue
studies
in
grains
and
processed
grains
are
fulfilled
according
to
an
HED
memo
dated
January
10,
2001
(DP
Barcode,
D268415).
This
conclusion
will
be
incorporated
into
a
revised
chapter.
Existing
labels
carry
a
Lima
bean
use
restriction.
The
Agency
agreed
to
remove
this
restriction
(July
2001,
J.
Punzi
written
reply
to
Nang
Ly
Chow).
This
restriction
will
be
removed
in
the
revised
chapter.
The
ETF
is
proposing
a
tolerance
of
1.
0
ppm
for
crop
group
9.
2
As
noted
in
the
January
3,
2001
Residue
Chemistry
Chapter,
the
available
residue
data
are
adequate
to
support
this
use.
The
existing
tolerance
for
mustard
seed
will
be
maintained.
The
Agency
will
review
MRID#
00003724
for
this
use
and
examine
application
rates
and
use
parameters.
The
ETF
and
IR
4
are
asking
the
Agency
to
review
MRID#
s
00138256,
00003587,
and
00003843,
as
well
as
available
raspberry
data
for
adequacy
in
supporting
a
crop
group
tolerance
for
cane
berry.
The
Agency
will
review
the
appropriate
studies
for
this
use
and
examine
application
rates
and
use
parameters.
The
ETF
are
asking
the
Agency
to
consider
available
data
to
support
a
crop
group
tolerance
for
fruiting
vegetables
(Crop
Group
8).
The
Agency
will
review
the
available
data.
The
ETF
is
proposing
that
the
Agency
translate
existing
residue
data
from
potatoes
and
carrots
(root
portion)
and
turnip
greens,
sugarbeet
tops,
kale
and
spinach
(leafy
portion)
to
rutabaga
and
radish.
The
ETF
notes
that
radish
and
rutabaga
use
is
permitted
on
Canadian
labels
and
for
harmonization
reasons
under
NAFTA,
the
data
translation
described
above
is
appropriate.
The
Agency
will
review
the
appropriate
data.
The
ETF
is
requesting
a
tolerance
for
pistachio
nuts
by
translation
of
the
available
data
for
almonds
(MRID#
s
00003713
and
00004254).
The
Agency
will
review
the
available
data.
The
ETF
is
proposing
to
retain
current
labeled
Post
Harvest
Intervals
for
celery
and
leaf
lettuce
and
to
raise
the
tolerances
to
8
ppm
(celery)
and
6
ppm
(leaf
lettuce).
The
proposal
is
supported
by
residue
chemistry
studies
MRID#
s
44346904,
44346906
performed
in
1995.
The
Agency
will
review
all
available
data
for
endosulfan
in/
on
lettuce
and
celery
and
determine
the
adequacy
of
the
data.
The
ETF
notes
that
the
Agency
used
a
pineapple
processing
study
(MRID#
00157147)
to
determine
the
concentration
factors
in
pineapple
peel
and
pineapple
wet
bran.
The
Agency
did
not
review
MRID#
44617402
for
tolerance
reassessment.
Therefore,
the
ETF
requests
that
the
data
be
reviewed
to
determine
processing
factors
for
pineapple
juice
and
pineapple
processed
3
residue/
wet
bran.
The
Agency
will
review
all
available
data
for
endosulfan
in/
on
pineapple
and
determine
the
adequacy
of
the
data.
The
ETF
does
not
agree
with
the
Agency's
calculation
of
a
maximum
dietary
burden
(MDB)
using
pineapple
processed
residues
as
20
30
%
of
the
total
diet.
The
ETF
correctly
states
this
would
be
very
localized
since
Hawaii
is
the
only
state
where
pineapples
are
grown.
Furthermore,
since
the
MDB
is
based
on
the
pineapple
residues
from
the
processing
study,
inappropriate
values
were
used
in
the
computation.
The
MDB
reflects
very
conservative
diets
based
on
worst
case
scenarios.
Livestock
used
for
meat
and
milk
in
Hawaii
and
subsequent
exposure
to
residues
of
endosulfan
is
not
unrealistic
in
acute
assessments.
While
the
animal
diet
may
be
inappropriate
to
use
for
an
exposure
assessment,
the
dietary
risks
are
small.
Based
on
a
revised
MDB,
reassessed
tolerances
for
fat,
meat
byproducts,
liver,
meat
and
milk
need
to
be
revised.
We
will
review
the
appropriate
pineapple
study
and
make
a
recommendation.
The
ETF
identified
one
error
in
the
end
use
labels;
The
maximum
application
rate
for
the
emulsifiable
concentrate
(EC)
formulation
used
on
walnuts
reads
2.5
lb
ai/
A
in
the
text.
The
ETF
believes
this
is
an
error
as
the
labels
read
2.0
lb
ai/
A.
The
Agency
has
indeed
verified
that
there
is
a
label
(reg.#
10163
110)
for
an
EC
formulation
to
be
used
at
2.
5
lbs
ai/
A.
As
a
point
of
reference,
2
lbs
ai/
A
was
used
for
the
wettable
powder
(reg.#
279
2659).
The
Agency
assesses
exposures
up
to
the
highest
application
rate
for
which
there
is
a
current
registration.
The
Agency
is
reviewing
whether
the
submitted
residue
data
support
these
application
rates.
The
ETF
has
noted
possible
errors
and
requests
correction
for
revisions
to
the
chapter:
Errors
in
Table
8:
Almonds
reassessed
to
0.
2
ppm
vs
0.3
ppm
as
listed
in
the
text.
Cotton
gin
byproducts
reassessed
to
30
ppm
vs
28
ppm
listed
in
the
text.
The
Agency
will
revise
the
appropriate
sections
as
identified
in
this
response
before
the
RED
for
endosulfan
is
finalized.
4
III.
Dietary
(Food)
Assessment
99.9
th
Percentile
Policy
Not
Consistently
Applied
In
HED's
dietary
assessment,
exposure
to
all
populations
was
assessed
at
the
99.
9
th
percentile,
not
just
children
1
6
years
of
age.
Regulating
at
the
99.9
th
percentile
is
HED's
current
approach
when
the
assessment
includes
such
refinements
as
the
use
of
monitoring
data,
percent
crop
treated,
and
processing
data.
The
endosulfan
assessment
includes
all
of
these
refinements.
Percent
of
Food
Treated
in
Acute
Risk
Assessment
The
current
approach
for
the
application
of
percent
crop
treated
estimates
was
used
in
the
endosulfan
dietary
assessment.
The
maximum
percent
crop
treated
estimates
were
used
in
the
acute
dietary
assessment,
and
the
weighted
average
estimates
were
used
in
the
chronic
dietary
assessment.
The
acute
dietary
assessment
was
also
done
in
accordance
with
HED
SOP
99.6:
Classification
of
Food
Forms
With
Respect
to
Level
of
Blending
(8/
20/
99).
IV.
Drinking
Water
Drinking
Water
Levels
of
Comparison,
derived
from
dietary
(food)
exposures
estimated
at
the
99.9
th
percentile,
were
compared
to
drinking
water
exposures
calculated
at
the
90
th
percentile.
This
underestimates
risk.
The
Environmental
Fate
and
Effects
Division
(EFED),
which
conducts
the
drinking
water
assessment,
uses
the
90
th
percentile
in
its
calculations
to
provide
HED
with
a
somewhat
conservative
estimate
in
which
it
is
assumed
that
one
high/
maximum
concentration
event
will
occur
once
every
ten
years
for
just
one
day
during
that
year.
It
is
EFED's
standard
policy
to
use
this
1
in
10
year
storm
event.
With
additional
data,
further
refinements
could
be
made.
V.
Toxicology
Endocrine
disruption
As
part
of
the
hazard
characterization
required
for
risk
assessment,
the
toxicological
database
for
endosulfan
was
reviewed
and
evaluated,
and
is
suggestive
of
endocrine
related
effects
due
to
endosulfan
exposure.
The
concern
that
endosulfan
may
be
an
endocrine
disruptor
is
based
on
reports
in
the
open
literature
and
in
studies
submitted
to
the
Agency.
The
Agency's
weight
of
evidence
that
endosulfan
may
be
an
endocrine
disruptor
is
presented
in
Appendix
A
of
the
HED
Toxicology
Chapter
(HED
DOC
Number:
014049,
dated
November
12,
1999).
The
ETF
submitted
its
own
weight
of
evidence
report
(MRID
44939102)
in
evaluating
the
potential
endocrine
effects
of
endosulfan;
which
was
reviewed
by
the
Agency
(ENDOSULFAN:
1
Crisp,
T.
M.
et
al.
Environmental
Endocrine
Disruption:
An
Effects
Assessment
and
Analysis.
Environmental
Health
Perpectives
106
pp.
11
56.
2
ATSDR
Toxicity
Profile
for
Endosulfan.
September,
2000.
5
Evaluation
of
Registrant
Submission
Endosulfan:
Evaluation
of
Possible
Endocrine
Effects
in
Mammalian
Species.
Elizabeth
Méndez.
December
11,
2000).
After
reviewing
several
published
articles,
the
ETF
concluded
that
"endosulfan
does
not
meet
the
criteria
of
an
endocrine
disruptor."
The
registrant
stated
that
in
vitro
studies
show
that
endosulfan
has
a
low
binding
potency
to
the
human
estrogen
receptors
and
that
"no
effects
were
found
on
endocrine,
reproductive
or
sexually
regulated
systems
in
vivo
at
doses
causing
clear
toxicity."
The
Agency
identifies
an
environmental
endocrine
disruptor
as
an
exogenous
agent
that
interferes
with
the
synthesis,
secretion,
transport,
binding
action,
or
elimination
of
natural
hormones
in
the
body
that
are
responsible
for
the
maintenance
of
homeostasis,
reproduction,
development,
and/
or
behavior.
1
Based
on
these
criteria,
the
Agency
disagrees
with
the
conclusion
by
the
registrant
that
endosulfan
does
not
meet
the
definition
of
an
endocrine
disruptor.
Binding
to
the
estrogen
receptor
is
only
one
potential
mode
of
action
for
endocrine
disruptors,
namely
direct
interaction
with
a
receptor
in
the
target
cells.
Substances
that
act
as
endocrine
disruptors
may
perturb
the
endocrine
system
in
a
variety
of
ways
including
but
not
limited
to
interfering
with
the
synthesis,
secretion,
or
transport
of
hormones
in
the
organism.
Some
examples
of
endocrine
disruption
that
do
not
involve
receptor
binding
are:
1)
depression
of
the
steroidogenic
enzymes
and
cytochrome
P450
dependent
monooxygenases,
which
suggests
that
conversion
of
cholesterol
to
testosterone
may
be
affected
by
endosulfan;
2)
decreases
in
luteinizing
hormone
(LH)
activity
that
may
result
in
decreases
in
the
activity
of
Steroidogenic
Acute
Regulatory
Protein
responsible
for
translocation
of
cholesterol
from
the
cytosol
to
the
inner
mitochondria
[transport
and
synthesis
affected];
and
3)
effects
on
the
sex
hormone
binding
globulin
(SHBG)
as
indicated
by
decreases
in
plasma
and
testicular
testosterone
in
conjunction
with
serum
testosterone
[effect
on
hormone
transport].
2
Consequently,
the
absence
of
high
binding
affinity
to
the
estrogen
receptor
should
not
be
interpreted
as
lack
of
endocrine
disruption
potential.
The
Agency
notes
that
other
organochlorines
(i.
e.
DDT,
DDE,
dieldrin,
and
methoxychlor)
have
been
demonstrated
to
interact
with
the
endocrine
system
in
spite
of
differing
binding
affinities
to
the
estrogen
receptor.
Finally,
the
registrant
states
that
no
effects
were
reported
after
administration
of
endosulfan
on
the
endocrine,
reproductive
or
sexually
regulated
systems
at
doses
causing
clear
toxicity.
However,
it
is
noteworthy
that
testicular
atrophy
was
reported
during
a
Chronic
Oral
Toxicity
Study
in
Rats
(MRID#
00004256)
submitted
to
the
Agency.
Additionally,
increased
pituitary
and
uterine
weights
were
also
observed
during
a
Multi
Generation
Reproduction
Study
(MRID#
00148264).
Furthermore,
an
increase
in
the
incidence
of
parathyroid
hyperplasia
was
also
reported
during
the
Chronic
Oral
Toxicity
study
in
Rats.
The
Agency
emphasizes
the
fact
that
the
endocrine
system
integrates
a
variety
of
CNS
pituitary
target
organ
pathways
that
not
only
affect
reproductive
or
sexually
regulated
parameters
but
also
regulates
a
wide
array
of
bodily
3
R.
L.
Cooper
and
R.
J.
Kavlock.
Endocrine
Disruptors
and
Reproductive
Development:
a
Weight
of
Evidence
Overview.
J.
Endocrinology
152
pp.
159.
166
6
functions
and
homeostasis.
3
Though
this
is
not
the
case
for
endosulfan,
it
is
important
to
note
that
a
lack
of
overt
toxicity
to
the
reproductive
system
should
not
be
interpreted
as
conclusive
evidence
of
a
lack
of
endocrine
disruption.
Given
the
effects
noted
in
the
Chronic
Oral
Toxicity
Study
in
Rats
and
the
Multi
Generation
Reproduction
Study
submitted
to
the
Agency,
the
potential
of
endosulfan
to
act
as
an
endocrine
disruptor
can
not
be
discounted.
The
Agency
has
requested
that
a
Developmental
Neurotoxicity
Study
be
conducted;
the
Agency
believes
that
this
study
will
provide
additional
data
that
may
help
elucidate
this
matter.
Selection
of
toxicology
endpoints
for
dermal
and
inhalation
NOAELs
A
re
review
of
the
of
the
study
(MRID#
00146841,
00147744)
selected
for
establishing
the
dermal
NOAEL
and
LOAEL
indicates
that
9
mg/
kg/
day
is
not
an
effect
level.
In
this
study,
rats
were
treated
dermally
for
21
days
at
dose
levels
of
0,
1,
3,
9,
27
or
81
(males
only)
mg/
kg/
day.
At
9
mg/
kg/
day,
2/
6
males
died;
at
27
mg/
kg/
day
no
mortalities
were
observed
in
males
and
3/
6
females
died,
and
at
81
mg/
kg/
day
3/
6
males
died.
The
two
males
which
died
at
9
mg/
kg/
day
may
have
been
a
result
of
non
treatment
related
causes
(very
small
immature
testes
and
livers).
It
is
biologically
improbable
to
have
lethality
at
one
dose,
no
lethality
at
a
three
fold
higher
dose
and
lethality
again
at
a
nine
fold
higher
dose
The
histopathological
findings
were
also
reexamined.
The
study
pathology
report
states
that
the
two
males
in
the
9
mg/
kg/
day
group
and
the
5
females
in
the
27
mg/
kg/
day
group
"showed
signs
of
incipient
and
in
some
cases
advanced,
autolysis."
Further,
there
was
no
apparent
dose
response
for
the
incidence
of
histopathological
findings
in
the
liver.
In
another
dermal
toxicity
study,
animals
were
dosed
at
0,
3,
6,
12,
48,
96
(males
only)
or
192
(males
only)
mg/
kg/
day.
The
NOAEL
for
this
study
was
established
at
12
mg/
kg/
day
in
females
and
96
mg/
kg/
day
in
males,
based
on
increased
mortalities
at
48
mg/
kg/
day
in
females
and
at
192
mg/
kg/
day
in
males.
The
selection
of
the
appropriate
NOAEL
for
dermal
toxicity
will
be
deferred
to
HED's
Hazard
Identification
Assessment
Review
Committee
(HIARC).
Endosulfan
is
not
likely
to
bioaccumulate
The
most
compelling
evidence
to
support
the
ETF
claim
that
endosulfan
does
not
bioaccumulate
was
presented
in
a
recently
submitted
toxicokinetic
study
(MRID#
45546201).
In
this
study,
14
C
endosulfan
(1
mg/
kg/
day)
was
administered
to
male
and
female
rats
for
up
to
28
days.
A
steady
state
concentration
in
blood
and
tissues
was
achieved
by
day
23.
At
day
28,
7
treatment
was
stopped
and
blood
and
tissue
levels
of
labeled
residues
were
measured
for
5
days.
At
the
end
of
the
treatment
free
period,
there
was
no
evidence
that
indicated
that
endosulfan
bioaccumulates.
Only
9.253%
of
the
total
administered
dose
remained
in
males
and
9.
794%,
in
females
at
the
end
of
the
treatment
free
period
(i.
e.
over
90%
of
the
radioactivity
was
eliminated).
The
use
of
a
3
fold
factor
to
account
for
lack
of
long
term
dermal
study
In
the
absence
of
dermal
toxicity
studies
beyond
30
days
exposure,
the
HIARC
concluded
(HED
Doc
No:
014024)
that
an
additional
3X
factor
is
needed
to
address
the
uncertainty
in
extrapolating
data
from
greater
than
30
days
up
to
several
months
and/
or
years.
This
factor
was
added
based
on
concerns
that
endosulfan
bioaccumulates.
A
recently
submitted
toxicokinetic
study
(MRID#
45546201)
provides
evidence
that
endosulfan
does
not
bioaccumulate.
However,
the
decision
to
retain
or
remove
the
3
fold
safety
factor
will
be
made
by
the
HIARC.
The
NOAEL
from
the
oral
study
for
assessing
worker
inhalation
risks
While
there
appears
to
be
merit
to
the
ETF
evaluation
of
the
inhalation
data,
the
action
requested
by
the
ETF
is
global
in
nature
and
effects
not
only
endosulfan,
but
other
chemicals
as
well.
The
use
of
oral
toxicity
data
to
establish
an
inhalation
NOAEL
will
have
to
be
deferred
until
management
review.
VI.
Occupational
Exposure
Spray
Drift
and
Take
home
Exposures,
and
Exposures
to
Farmworker
Children
Spray
drift
is
always
a
potential
source
of
exposure
to
residents
nearby
to
spraying
operations.
This
is
particularly
the
case
with
aerial
application,
but,
to
a
lesser
extent,
could
also
be
a
potential
source
of
exposure
from
groundboom
application
methods.
The
Agency
has
been
working
with
the
Spray
Drift
Task
Force,
EPA
regional
offices
and
state
lead
agencies
for
pesticide
regulation
and
other
parties
to
develop
the
best
spray
drift
management
practices.
The
Agency
is
now
requiring
interim
mitigation
measures
for
aerial
applications
that
must
be
placed
on
product
labels/
labeling.
The
Agency
has
completed
its
evaluation
of
the
new
data
base
submitted
by
the
Spray
Drift
Task
Force,
of
which
U.
S.
pesticide
registrants
are
members,
and
is
developing
a
policy
on
how
to
appropriately
apply
the
data
and
the
AgDRIFT
computer
model
to
its
risk
assessments
for
pesticides
applied
by
air,
orchard
airblast
and
ground
hydraulic
methods.
After
the
policy
is
in
place,
the
Agency
may
impose
further
refinements
in
spray
drift
management
practices
to
reduce
off
target
drift
and
risks
associated
with
aerial
as
well
as
other
application
types,
where
appropriate.
In
addition,
the
Agency
is
currently
in
the
process
of
revising
its
guidance
for
completing
other
types
of
assessments,
such
as
exposure
to
farmworker
children.
Modifications
to
this
assessment
shall
be
incorporated
as
updated
guidance
becomes
available.
This
will
include
8
expanding
the
scope
of
the
residential
exposure
assessments
by
developing
guidance
for
characterizing
exposures
from
other
sources
already
not
addressed,
such
as
from
spray
drift;
residential
residue
track
in;
exposures
to
farmworker
children;
and
exposures
to
children
in
schools.
Assessing
baseline
clothing
for
occupational
mixing/
loading
activities
using
endosulfan
is
inconsistent
with
the
product
labels
and
US
EPA's
Worker
Protection
standard
and
should
be
dropped
from
the
assessment.
Baseline
clothing
attire
is
always
assessed
in
reregistration
assessments.
This
is
done
for
informational
purposes
in
order
to
determine
at
which
mitigation
level
the
risks
to
the
workers
are
no
longer
of
concern.
Also,
personal
protective
equipment
(PPE)
and
engineering
control
requirements
often
differ
on
currently
registered
labels
for
older
chemicals,
because
many
older
chemicals,
including
endosulfan,
have
a
large
number
of
registered
products
held
by
several
different
manufactures
and
the
registration
approval
dates
can
often
vary
widely.
The
Agency
does
take
the
present
PPE
and
engineering
controls
on
the
product
labels
into
consideration
during
the
risk
mitigation
process.
Many
of
the
occupational
handler
scenarios
presented
in
the
RED
represent
uses
that
are
not
supported
by
ETF
labels
and
should
be
removed
from
the
assessment.
These
are:
(1e)
mixing/
loading
of
liquids
for
rights
of
way
application;
(2d)
mixing/
loading
of
wettable
powders
for
rights
of
way
applications;
(6)
rights
of
way
spray
application;
(8)
mixing/
loading/
applying
of
liquids
with
a
low
pressure
handwand;
(9)
mixing/
loading/
applying
of
wettable
powders
with
a
low
pressure
handwand;
(10)
mixing/
loading/
applying
of
liquids
with
a
high
pressure
handwand.
The
rights
of
way
sprayer,
the
low
pressure
handwand,
and
the
high
pressure
handwand
are
considered
the
application
techniques
used
to
apply
liquids
and
wettable
powders
in
tree
bark
treatments.
The
low
and
the
high
pressure
handwands
are
also
known
to
be
commonly
used
in
greenhouses
and
in
drench
treatments.
Since
uses
in
greenhouses,
bark
and
drench
treatments
are
all
currently
registered
for
endosulfan,
the
above
occupational
scenarios
will
continue
to
be
assessed
by
the
Agency
and
included
in
the
risk
assessment.
The
use
of
a
50
percent
protection
factor
for
a
second
layer
of
clothing
is
conservative
and
overestimates
exposure.
This
is
in
conflict
with
the
90%
protection
factor
used
by
the
California
Department
of
Pesticide
Regulation.
According
to
Agency
data,
there
is
a
range
of
protection
levels
provided
by
a
second
layer
of
clothing.
While
the
90%
protection
factor
is
included
in
this
range,
the
Agency
uses
the
50
percent
protection
factor
in
order
to
provide
the
maximum
protection
to
the
worker.
This
number
takes
into
account
the
variations
in
the
types
of
clothing
that
could
be
used
and
any
possible
rips
or
holes
in
the
second
layer
of
clothing.
In
the
case
of
endosulfan,
it
is
more
appropriate
to
use
the
NOEL
from
the
oral
study
for
9
assessing
worker
inhalation
risks
than
the
NOEL
from
the
inhalation
study.
The
Agency
is
currently
considering
this
matter,
since
this
is
an
issue
that
has
arisen
for
several
other
pesticides
and
will
affect
the
overall
regulation
of
all
pesticides.
When
there
is
a
decision
on
this
issue
in
the
Agency,
the
occupational
risk
assessment
will
be
revised
as
appropriate.
Until
then,
the
inhalation
endpoint
will
be
used
as
it
currently
stands
and
this
issue
will
be
considered
when
characterizing
the
inhalation
risk
during
the
risk
mitigation
phase.
Also
see
Section
V
above.
Use
of
biphasic
kinetics
to
calculate
predicted
dislodgeable
foliar
residue
(DFR)
values
better
represents
the
data
and
provides
higher
R
squared
values
for
the
critical
phase
1
period
than
a
linear
assumption.
HED
will
reanalyze
the
distribution
of
the
DFR
data
using
the
biphasic
method
and
will
determine
which
method,
linear
or
biphasic,
best
represents
the
distribution
of
the
data
and
produces
the
highest
R
squared
value.
Any
changes
in
the
analysis
of
the
DFR
data
will
be
reflected
in
the
next
revision
of
the
occupational
exposure
assessment.
ETF
believes
that
a
50%
protection
factor
is
a
reasonable
default
for
the
use
of
protective
headgear.
HED
agrees
that
a
chemical
resistant
headgear
may
reduce
pesticide
exposure.
A
protection
factor
has
not
been
established
by
the
Agency
for
the
use
of
headgear;
therefore,
occupational
exposure
risk
estimates
are
not
quantitatively
reduced
to
take
this
protective
clothing
into
account.
One
problem
in
setting
a
generic
protection
factor
for
chemical
resistant
headgear
is
that
headgear
can
come
in
a
wide
range
of
styles,
materials,
etc.
This
causes
the
amount
of
protection
that
headgear
can
provide
to
vary
widely.
Even
so,
the
MOEs
for
airblast
applicators
presently
range
from
3.
2
to
24
at
the
additional
PPE
mitigation
level
for
dermal
risk.
The
use
of
a
50%
protection
factor
for
head/
neck
exposure
would
not
increase
the
highest
MOE
to
more
than
36,
which
is
still
far
below
the
target
MOE
of
100.
HED
will
take
into
consideration
any
data
submitted
to
support
the
ETF's
assumption
that
chemical
resistant
headgear
reduces
head/
neck
exposure
by
50%.
600
acres/
day
should
be
used
for
applications
to
small
grains
instead
of
1200
acres/
day,
based
on
California
Department
of
Pesticide
Regulation
defaults.
Due
to
the
small
size
of
ornamental
operations,
40
acres
per
day
is
not
realistic,
and
10
acres
per
day
should
be
used.
The
small
grains
treated
with
endosulfan;
rye,
oats,
barley
and
wheat;
were
considered
to
have
a
1,
200
acre
per
day
amount
treated
rate
based
on
the
values
for
wheat
in
the
National
Agricultural
Aviation
Association's
1998
Industrial
Survey
for
Agricultural
Aviation,
Timber
Mill
Research,
Inc.,
June
1998
(values
for
acres
treated
per
day
range
from
970
to
1,625
for
wheat
).
Barley,
rye,
oats
and
wheat
all
have
the
same
maximum
application
rate
of
0.
75
lbs
ai/
acre.
HED
considers
1,
200
acres
per
day
to
be
a
reasonable
assumption
for
small
grains
treated
with
10
endosulfan.
HED
now
considers
10
acres
treated
per
day
to
be
a
realistic
assumption
for
ornamentals
and
future
revisions
of
the
occupational
assessment
will
reflect
this.
Some
of
the
MOEs
are
calculated
assuming
that
PPE
or
engineering
controls
will
be
in
use.
EPA
must
remember
that
in
many
instances
PPE
is
not
provided,
does
not
fit
properly
or
is
uncomfortable
to
wear.
Occupational
risks
are
assessed
with
PPE
or
engineering
controls
in
order
to
determine
what
risk
mitigation
can
be
employed.
If
PPE
or
engineering
controls
are
determined
to
be
necessary
to
reduce
the
risk
to
a
pesticide,
then
that
condition/
restriction
will
be
placed
on
the
label
(if
not
already
present).
Any
deviations
from
the
use
of
required
label
PPE
or
engineering
controls
is
considered
by
the
EPA
to
be
a
misuse
of
the
pesticide
product.
HED
does
not
assess
risks
resulting
from
the
misuse
of
a
pesticide
product.
VII.
Incident
Data
The
Agency
has
not
included
a
number
of
important
incident
reports
in
its
evaluation
of
the
incident
data.
The
Agency's
Incident
Report
was
written
in
the
year
2000
and
the
Agency
is
aware
that
a
great
deal
more
information
is
now
available.
A
quick
MEDLINE/
PubMed
search
at
the
National
Library
of
Medicine
web
site,
revealed
560
entries
for
endosulfan.
Many
recent
entries
use
new
multiresidue
analytical
chemistry
measurement
methods.
Some
poisonings
date
back
to
1970
in
Germany.
The
literature
entries
reflect
mostly
international
pesticide
poisoning
incident
case
reports
referred
to
by
PAN
Asia
and
the
Pacific/
PAN
North
America
{Docket
#34242}
and
Ohio
based
Rural
Action
Safe
Pest
Control
Program
{Docket
#34242},
and
some
studies
appear
to
be
consistent
with
the
thrust
of
their
concerns.
Specifically,
endosulfan
is
a
wide
spread
and
commonly
measured
contaminant
of
the
human
environment.
Evidence
from
various
places
and
test
systems
is
beginning
to
suggest
internal
enzyme,
endocrine,
and
neuronal
regulation
changes
at
the
cellular
and
sub
cellular
levels.
Of
particular
concern
are
the
neuronal
gap
junction
and
MAP
K
(kinase)
nerve
to
nerve
cell
communication
disturbances
in
test
cell
systems
and
other
evidence
of
endocrine
disruption.
A
further
concern
is
that
persistent
organochlorine
pesticides
(POPS)
tend
to
co
occur
in
fatty
foods
like
fish,
thus
necessitating
more
complex
analysis
on
the
implications
of
aggregate
and
cumulative
exposure.
The
number
and
diversity
of
recent
publications
that
include
endosulfan,
suggest
the
need
for
a
more
careful
literature
review
during
the
upcoming
risk
assessment
revision
process.
| epa | 2024-06-07T20:31:43.940822 | regulations | {
"license": "Public Domain",
"url": "https://downloads.regulations.gov/EPA-HQ-OPP-2002-0262-0003/content.txt"
} |
EPA-HQ-OPP-2002-0263-0001 | Notice | "2002-10-22T04:00:00" | Notice of Filing a Pesticide Peititionto Establish a Tolerance for a Certain Pesticide Chemical in or on
Food | 64881
Federal
Register
/
Vol.
67,
No.
204
/
Tuesday,
October
22,
2002
/
Notices
ENVIRONMENTAL
PROTECTION
AGENCY
[OPP–
2002–
0263;
FRL–
7275–
7]
Notice
of
Filing
a
Pesticide
Petition
to
Establish
a
Tolerance
for
a
Certain
Pesticide
Chemical
in
or
on
Food
AGENCY:
Environmental
Protection
Agency
(EPA).
ACTION:
Notice.
SUMMARY:
This
notice
announces
the
initial
filing
of
a
pesticide
petition
proposing
the
establishment
of
regulations
for
residues
of
Bacillus
subtilis
var.
amyloliquefaciens
strain
FZB24
in
or
on
various
food
commodities.
DATES:
Comments,
identified
by
docket
ID
number
OPP–
2002–
0263,
must
be
received
on
or
before
November
21,
2002.
ADDRESSES:
Comments
may
be
submitted
electronically,
by
mail,
or
through
hand
delivery/
courier.
Follow
the
detailed
instructions
as
provided
in
Unit
I.
of
the
SUPPLEMENTARY
INFORMATION.
FOR
FURTHER
INFORMATION
CONTACT:
Robyn
Rose,
Biopesticides
and
Pollution
Prevention
Division
(7511C),
Office
of
Pesticide
Programs,
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460–
0001;
telephone
number:
(703)
308–
9581;
e
mail
address:
rose.
robyn@
epa.
gov.
SUPPLEMENTARY
INFORMATION:
I.
General
Information
A.
Does
this
Action
Apply
to
Me?
You
may
be
potentially
affected
by
this
action
if
you
are
an
agricultural
producer,
food
manufacturer,
or
pesticide
manufacturer.
Potentially
affected
entities
may
include,
but
are
not
limited
to:
Industry
(NACIS
111,
112,
311,
32532),
e.
g.,
crop
production,
animal
production,
food
manufacturing,
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
ID
number
OPP–
2002–
0263.
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/.
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.
Certain
types
of
information
will
not
be
placed
in
EPA
Dockets.
Information
claimed
as
CBI
and
other
information
whose
disclosure
is
restricted
by
statute,
which
is
not
included
in
the
official
public
docket,
will
not
be
available
for
public
viewing
in
EPA's
electronic
public
docket.
EPA's
policy
is
that
copyrighted
material
will
not
be
placed
in
EPA's
electronic
public
docket
but
will
be
available
only
in
printed,
paper
form
in
the
official
public
docket.
To
the
extent
feasible,
publicly
available
docket
materials
will
be
made
available
in
EPA's
electronic
public
docket.
When
a
document
is
selected
from
the
index
list
in
EPA
Dockets,
the
system
will
identify
whether
the
document
is
available
for
viewing
in
EPA's
electronic
public
docket.
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.
EPA
intends
to
work
towards
providing
electronic
access
to
all
of
the
publicly
available
docket
materials
through
EPA's
electronic
public
docket.
For
public
commenters,
it
is
important
to
note
that
EPA's
policy
is
that
public
comments,
whether
submitted
electronically
or
in
paper,
will
be
made
available
for
public
viewing
in
EPA's
electronic
public
docket
as
EPA
receives
them
and
without
change,
unless
the
comment
contains
copyrighted
material,
CBI,
or
other
information
whose
disclosure
is
restricted
by
statute.
When
EPA
identifies
a
comment
containing
copyrighted
material,
EPA
will
provide
a
reference
to
that
material
in
the
version
of
the
comment
that
is
placed
in
EPA's
electronic
public
docket.
The
entire
printed
comment,
including
the
copyrighted
material,
will
be
available
in
the
public
docket.
Public
comments
submitted
on
computer
disks
that
are
mailed
or
delivered
to
the
docket
will
be
transferred
to
EPA's
electronic
public
docket.
Public
comments
that
are
mailed
or
delivered
to
the
docket
will
be
scanned
and
placed
in
EPA's
electronic
public
docket.
Where
practical,
physical
objects
will
be
photographed,
and
the
photograph
will
be
placed
in
EPA's
electronic
public
docket
along
with
a
brief
description
written
by
the
docket
staff.
C.
How
and
To
Whom
Do
I
Submit
Comments?
You
may
submit
comments
electronically,
by
mail,
or
through
hand
delivery/
courier.
To
ensure
proper
receipt
by
EPA,
identify
the
appropriate
docket
ID
number
in
the
subject
line
on
the
first
page
of
your
comment.
Please
ensure
that
your
comments
are
submitted
within
the
specified
comment
period.
Comments
received
after
the
close
of
the
comment
period
will
be
marked
``
late.
''
EPA
is
not
required
to
consider
these
late
comments.
If
you
wish
to
submit
CBI
or
information
that
is
otherwise
protected
by
statute,
please
follow
the
instructions
in
Unit
I.
D.
Do
not
use
EPA
Dockets
or
e
mail
to
submit
CBI
or
information
protected
by
statute.
1.
Electronically.
If
you
submit
an
electronic
comment
as
prescribed
in
this
unit,
EPA
recommends
that
you
include
your
name,
mailing
address,
and
an
email
address
or
other
contact
information
in
the
body
of
your
comment.
Also
include
this
contact
information
on
the
outside
of
any
disk
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Register
/
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67,
No.
204
/
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October
22,
2002
/
Notices
or
CD
ROM
you
submit,
and
in
any
cover
letter
accompanying
the
disk
or
CD
ROM.
This
ensures
that
you
can
be
identified
as
the
submitter
of
the
comment,
and
allows
EPA
to
contact
you
in
case
EPA
cannot
read
your
comment
due
to
technical
difficulties
or
needs
further
information
on
the
substance
of
your
comment.
EPA's
policy
is
that
EPA
will
not
edit
your
comment,
and
any
identifying
or
contact
information
provided
in
the
body
of
a
comment
will
be
included
as
part
of
the
comment
that
is
placed
in
the
official
public
docket,
and
made
available
in
EPA's
electronic
public
docket.
If
EPA
cannot
read
your
comment
due
to
technical
difficulties
and
cannot
contact
you
for
clarification,
EPA
may
not
be
able
to
consider
your
comment.
2.
EPA
Dockets—
i.
Your
use
of
EPA's
electronic
public
docket
to
submit
comments
to
EPA
electronically
is
EPA's
preferred
method
for
receiving
comments.
Go
directly
to
EPA
Dockets
at
http://
www.
epa.
gov/
edocket,
and
follow
the
online
instructions
for
submitting
comments.
Once
in
the
system,
select
``
search,
''
and
then
key
in
docket
ID
number
OPP–
2002–
0263.
The
system
is
an,
``
anonymous
access''
system,
which
means
EPA
will
not
know
your
identity,
e
mail
address,
or
other
contact
information
unless
you
provide
it
in
the
body
of
your
comment.
ii.
E
mail.
Comments
may
be
sent
by
e
mail
to
opp
docket@
epa.
gov,
Attention:
Docket
ID
Number
OPP–
2002–
0263.
In
contrast
to
EPA's
electronic
public
docket,
EPA's
e
mail
system
is
not
an
``
anonymous
access''
system.
If
you
send
an
e
mail
comment
directly
to
the
docket
without
going
through
EPA's
electronic
public
docket,
EPA's
e
mail
system
automatically
captures
your
e
mail
address.
E
mail
addresses
that
are
automatically
captured
by
EPA's
e
mail
system
are
included
as
part
of
the
comment
that
is
placed
in
the
official
public
docket,
and
made
available
in
EPA's
electronic
public
docket.
iii.
Disk
or
CD
ROM.
You
may
submit
comments
on
a
disk
or
CD
ROM
that
you
mail
to
the
mailing
address
identified
in
Unit
I.
C.
2.
These
electronic
submissions
will
be
accepted
in
WordPerfect
or
ASCII
file
format.
Avoid
the
use
of
special
characters
and
any
form
of
encryption.
2.
By
mail.
Send
your
comments
to:
Public
Information
and
Records
Integrity
Branch
(PIRIB),
Office
of
Pesticide
Programs
(OPP),
Environmental
Protection
Agency
(7502C),
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460–
0001,
Attention:
Docket
ID
Number
OPP–
2002–
0263.
3.
By
hand
delivery
or
courier.
Deliver
your
comments
to:
Public
Information
and
Records
Integrity
Branch
(PIRIB),
Office
of
Pesticide
Programs
(OPP),
Environmental
Protection
Agency,
Rm.
119,
Crystal
Mall
#2,
1921
Jefferson
Davis
Hwy.,
Arlington,
VA,
Attention:
Docket
ID
Number
OPP–
2002–
0263.
Such
deliveries
are
only
accepted
during
the
docket's
normal
hours
of
operation
as
identified
in
Unit
I.
B.
1.
D.
How
Should
I
Submit
CBI
To
the
Agency?
Do
not
submit
information
that
you
consider
to
be
CBI
electronically
through
EPA's
electronic
public
docket
or
by
e
mail.
You
may
claim
information
that
you
submit
to
EPA
as
CBI
by
marking
any
part
or
all
of
that
information
as
CBI
(if
you
submit
CBI
on
disk
or
CD
ROM,
mark
the
outside
of
the
disk
or
CD
ROM
as
CBI
and
then
identify
electronically
within
the
disk
or
CD
ROM
the
specific
information
that
is
CBI).
Information
so
marked
will
not
be
disclosed
except
in
accordance
with
procedures
set
forth
in
40
CFR
part
2.
In
addition
to
one
complete
version
of
the
comment
that
includes
any
information
claimed
as
CBI,
a
copy
of
the
comment
that
does
not
contain
the
information
claimed
as
CBI
must
be
submitted
for
inclusion
in
the
public
docket
and
EPA's
electronic
public
docket.
If
you
submit
the
copy
that
does
not
contain
CBI
on
disk
or
CD
ROM,
mark
the
outside
of
the
disk
or
CD
ROM
clearly
that
it
does
not
contain
CBI.
Information
not
marked
as
CBI
will
be
included
in
the
public
docket
and
EPA's
electronic
public
docket
without
prior
notice.
If
you
have
any
questions
about
CBI
or
the
procedures
for
claiming
CBI,
please
consult
the
person
listed
under
FOR
FURTHER
INFORMATION
CONTACT.
E.
What
Should
I
Consider
as
I
Prepare
My
Comments
for
EPA?
You
may
find
the
following
suggestions
helpful
for
preparing
your
comments:
1.
Explain
your
views
as
clearly
as
possible.
2.
Describe
any
assumptions
that
you
used.
3.
Provide
copies
of
any
technical
information
and/
or
data
you
used
that
support
your
views.
4.
If
you
estimate
potential
burden
or
costs,
explain
how
you
arrived
at
the
estimate
that
you
provide.
5.
Provide
specific
examples
to
illustrate
your
concerns.
6.
Make
sure
to
submit
your
comments
by
the
deadline
in
this
notice.
7.
To
ensure
proper
receipt
by
EPA,
be
sure
to
identify
the
docket
ID
number
assigned
to
this
action
in
the
subject
line
on
the
first
page
of
your
response.
You
may
also
provide
the
name,
date,
and
Federal
Register
citation.
II.
What
Action
is
the
Agency
Taking?
EPA
has
received
a
pesticide
petition
as
follows
proposing
the
establishment
and/
or
amendment
of
regulations
for
residues
of
a
certain
pesticide
chemical
in
or
on
various
food
commodities
under
section
408
of
the
Federal
Food,
Drug,
and
Cosmetic
Act
(FFDCA),
21
U.
S.
C.
346a.
EPA
has
determined
that
this
petition
contains
data
or
information
regarding
the
elements
set
forth
in
FFDCA
section
408(
d)(
2);
however,
EPA
has
not
fully
evaluated
the
sufficiency
of
the
submitted
data
at
this
time
or
whether
the
data
support
granting
of
the
petition.
Additional
data
may
be
needed
before
EPA
rules
on
the
petition.
List
of
Subjects
Environmental
protection,
Agricultural
commodities,
Feed
additives,
Food
additives,
Pesticides
and
pests,
Reporting
and
recordkeeping
requirements.
Dated:
October
7,
2002.
Janet
L.
Andersen,
Director,
Biopesticides
and
Pollution
Prevention
Division,
Office
of
Pesticide
Programs.
Summary
of
Petition
PP
2F06453
The
petitioner
summary
of
the
pesticide
petition
is
printed
below
as
required
by
FFDCA
section
408(
d)(
3).
The
summary
of
the
petition
was
prepared
by
Taensa,
Inc.
and
represents
the
view
of
the
petitioner.
The
petition
summary
announces
the
availability
of
a
description
of
the
analytical
methods
available
to
EPA
for
the
detection
and
measurement
of
the
pesticide
chemical
residues
or
an
explanation
of
why
no
such
method
is
needed.
EPA
has
received
a
pesticide
petition
2F06453
from
Taensa,
Inc.,
26
Sherman
Ct,
P.
O.
Box
764,
Fairfield,
CT
06430,
proposing
pursuant
to
section
408(
d)
of
the
Federal
Food,
Drug,
and
Cosmetic
Act
(FFDCA),
21
U.
S.
C.
346a(
d),
to
amend
40
CFR
part
180
to
establish
an
exemption
from
the
requirement
of
a
tolerance
for
the
microbial
pesticide
Bacillus
subtilis
var.
amyloliquefaciens
strain
FZB24.
Pursuant
to
section
408(
d)(
2)(
A)(
i)
of
the
FFDCA,
as
amended,
Taensa,
Inc.
has
submitted
the
following
summary
of
information,
data,
and
arguments
in
support
of
their
pesticide
petition.
This
summary
was
prepared
by
Taensa,
Inc.
EPA
has
not
fully
evaluated
the
merits
of
the
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204
/
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October
22,
2002
/
Notices
pesticide
petition.
The
summary
may
have
been
edited
by
EPA
if
the
terminology
used
was
unclear,
the
summary
contained
extraneous
material,
or
the
summary
unintentionally
made
the
reader
conclude
that
the
findings
reflected
EPA's
position
and
not
the
position
of
the
petitioner.
A.
Product
Name
and
Proposed
Use
Practices
TAEGRO
TM
is
currently
registered
with
EPA
for
use
on
ornamentals
in
greenhouses
and
indoors
(EPA
Registration
Number
72098–
5).
TAEGRO
TM
Technical
(EPA
Registration
Number
72098–
6)
is
also
registered
with
EPA.
Registration
of
TAEGRO
TM
is
being
proposed
for
the
following
sites
(including
those
previously
registered):
Herbs
and
spices;
ornamentals;
shrubs,
shade
and
forest
trees;
tree,
vine,
bush
and
other
crops;
turf;
and
vegetables.
Methods
of
application
of
TAEGRO
TM
will
include
seed
treatment,
incorporation
into
growth
substrate
as
a
dry
powder
or
as
an
aqueous
suspension,
drenching,
spraying,
dipping
(roots
or
cuttings),
spraying,
chemigation,
and
hydroponic
use.
As
a
plant
strengthening
agent,
TAEGRO
TM
increases
yield
of
many
crops,
improves
flowering
and
plant
quality,
stimulates
resistance
of
plants
to
disease,
plant
disease
suppressant
and
can
be
used
with
fungicides.
Directions
for
use
of
TAEGRO
TM
are
as
follows:
Apply
TAEGRO
TM
as
early
as
possible
in
the
life
cycle
of
the
plant
to
enhance
growth
and
disease
resistance.
TAEGRO
TM
should
be
applied
to
plants
every
few
weeks
for
up
to
three
to
four
applications
as
needed.
For
best
results,
apply
TAEGRO
TM
to
seedlings
or
to
newly
rooted
cuttings.
1.
Transplants,
including
plugs.
TAEGRO
TM
may
be
applied
to
transplants
by
dipping
or
by
drenching,
making
sure
the
root
system
is
thoroughly
soaked.
For
dipping,
follow
the
instructions
for
``
Cutting
and
Root
Dips''
before
planting
transplants
into
soil
medium.
For
drenching,
first
plant
the
transplants
into
soil
medium
and
then
follow
instructions
for
``
Drenching.
''
2.
Drenching.
Apply
TAEGRO
TM
to
seedlings
or
to
newly
rooted
cuttings.
Drench
plants
with
the
TAEGRO
TM
suspension
making
sure
the
root
system
is
thoroughly
soaked.
Allowing
TAEGRO
TM
to
work
into
the
root
zone.
Apply
TAEGRO
TM
as
follows:
Per
100
gallons
of
water
by
weight
use
75
grams
or
2.6
ounces;
by
volume
use
3.5
fluid
ounces
of
TAEGRO
TM
.
Per
1
gallon
of
water
5
grams
by
weight
use
0.75
gram;
by
volume
use
0.2
teaspoon
of
TAEGRO
TM
.
3.
Cutting
and
root
dips.
Stir
suspension
for
several
minutes
to
ensure
complete
mixture
and
to
eliminate
clumps.
Place
rootstock
in
the
suspension
for
5
to
10
minutes
allowing
time
for
TAEGRO
TM
to
penetrate
the
root
zone.
Ornamentals
should
receive
at
least
one
follow
up
drench
treatment
2
to
3
weeks
following
initial
treatment.
Apply
TAEGRO
TM
as
follows:
Per
10
gallons
of
water
by
weight,
use
40
grams;
by
volume,
1.8
fluid
ounces
of
TAEGRO
TM
.
Per
1
gallon
of
water
by
weight,
use
4
grams;
by
volume,
use
1
teaspoon
of
TAEGRO
TM
.
Per
1
Liter
of
water
by
weight,
use
1
gram
of
TAEGRO
TM
.
4.
Turf.
As
an
overhead
spray,
mix
75
grams
of
TAEGRO
TM
in
100
gallons
of
water.
Before
applying,
stir
product
for
several
minutes
to
ensure
complete
suspension.
Apply
solution
with
a
conventional
sprayer
using
at
least
50
gallons
of
water
per
acre.
Water
in
TAEGRO
TM
immediately
after
application
with
a
minimum
of
1/
10
inch
of
water.
For
best
results,
make
two
or
three
applications
spaced
1
week
apart.
5.
Row
crops.
Mix
75
grams
of
TAEGRO
TM
in
100
gallons
of
water.
Before
applying,
stir
product
for
several
minutes
to
ensure
complete
suspension.
At
time
of
(or
just
following)
planting,
apply
as
a
spray
over
furrow.
Water
in
TAEGRO
TM
immediately
after
application
with
a
minimum
of
1/
10
inch
of
water.
For
best
results,
make
two
or
three
applications
spaced
1
week
apart.
6.
Hydroponics.
Prepare
a
stock
solution
by
adding
1
gram
of
TAEGRO
TM
,
for
every
50
feet
of
irrigation
tubing,
in
1
gallon
of
water.
Stir
product
for
several
minutes
to
ensure
complete
suspension.
Add
solution
to
circulating
water
system
and
allow
to
go
through
three
to
five
watering
cycles
before
clearing
the
system.
For
best
results,
make
two
or
three
applications
spaced
1
week
apart.
7.
Seed
treatments.
Prior
to
planting,
mix
4
grams
of
TAEGRO
TM
in
1
liter
of
water
(or
3
teaspoons
per
gallon
of
water).
Stir
solution
for
several
minutes
to
ensure
complete
suspension.
Pour
seeds
into
solution
and
allow
to
soak
for
10
to
30
minutes.
For
very
small
seeds,
soaking
seedlings
in
plug
trays
after
germination
might
be
easier.
8.
Tubers,
bulbs
and
corms.
Mix
4
grams
of
TAEGRO
TM
in
1
liter
of
water
(or
3
teaspoons
per
gallon
of
water).
Stir
solution
for
several
minutes
to
ensure
complete
suspension.
Dip
tubers
(or
bulbs,
etc.)
for
10
to
30
minutes
before
planting.
For
best
results,
make
two
or
three
applications
spaced
1
week
apart.
9.
Soil
incorporation.
Mix
TAEGRO
TM
into
soil
or
soilless
growing
media
at
a
rate
of
250
grams
per
cubic
yard.
Thoroughly
mix
media,
using
mechanical
mixing
equipment,
to
ensure
a
uniform
distribution
of
product.
Incorporated
into
soil,
TAEGRO
TM
can
be
raked
into
growing
beds
prior
to
planting.
10.
Mushrooms.
Mix
TAEGRO
TM
into
spawn
medium
at
a
rate
of
10
grams
per
cubic
foot.
Thoroughly
mix,
using
mechanical
mixing
equipment,
to
ensure
a
uniform
distribution
of
product.
11.
Interiorscapes.
Before
application,
thoroughly
moisten
root
zone
with
water.
Mix
1
gram
of
TAEGRO
TM
per
1
liter
of
water
(or
3/
4
teaspoon
per
gallon
of
water).
Stir
solution
for
several
minutes
to
ensure
complete
suspension.
Drench
solution
onto
root
zone
to
ensure
coverage
to
all
roots.
TAEGRO
TM
performs
best
when
applied
to
seedlings
or
young
plants.
For
best
results,
make
two
or
three
applications
spaced
1
week
apart.
12.
Orchids
and
ferns.
For
potted
orchids
and
ferns,
follow
directions
for
drenching.
For
orchids
and
ferns
with
exposed
roots,
prepare
4
grams
of
TAEGRO
TM
in
1
liter
of
water
(or
3
teaspoons
per
gallon
of
water).
Pour
solution
into
spray
container
(or
squirt
bottle)
and
spray
roots
to
point
of
drip.
TAEGRO
TM
performs
best
when
applied
to
seedlings
or
young
plants.
For
best
results,
make
two
or
three
applications
spaced
1
week
apart.
B.
Product
Identity/
Chemistry
1.
Identity
of
pesticide
and
corresponding
residues.
The
active
ingredient
in
TAEGRO
TM
is
Bacillus
subtilis
var.
amyloliquefaciens
strain
FZB24.
The
mechanism
by
which
Bacillus
subtilis
var.
amyloliquefaciens
strain
FZB24
acts
as
a
plant
strengthening
agent,
increases
yield
of
many
crops,
improves
flowering
and
plant
quality,
stimulates
resistance
of
plants
to
disease,
plant
disease
suppressant
appears
to
be
primarily
via
secondary
exudates.
Suppression
of
plant
disease
by
Bacillus
subtilis
var.
amyloliquefaciens
strain
FZB24
may
also
be
competitive.
Bacillus
subtilis
var.
amyloliquefaciens
strain
FZB24
is
not
known
to
produce
toxins
or
antibiotics.
Further,
Bacillus
subtilis
var.
amyloliquefaciens
strain
FZB24
is
a
naturally
occurring
microorganism.
Bacillus
subtilis
var.
amyloliquefaciens
is
widespread
in
the
environment
and
occurs
in
most
arable
soils
of
the
world.
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Notices
2.
Magnitude
of
residue
anticipated
at
the
time
of
harvest
and
method
used
to
determine
the
residue.
No
residues
of
Bacillus
subtilis
var.
amyloliquefaciens
strain
FZB24
are
anticipated
in
treated
crops
at
harvest.
Subdivision
M
Series
153A
3(
a)
indicates
that
``
if
Tier
I
toxicology
tests
indicate
no
toxic
or
other
harmful
properties,
then
no
residue
data
would
be
indicated.
''
Studies
with
Bacillus
subtilis
var.
amyloliquefaciens
strain
FZB24
demonstrated
low
mammalian
toxicity.
No
pathogenicity
or
infectivity
was
observed
in
any
of
the
tests
conducted
with
Bacillus
subtilis
var.
amyloliquefaciens
strain
FZB24.
Further,
Bacillus
subtilis
var.
amyloliquefaciens
strain
FZB24
is
a
naturally
occurring
microorganism.
Bacillus
subtilis
var.
amyloliquefaciens
is
widespread
in
the
environment.
3.
Statement
of
why
an
analytical
method
for
detecting
and
measuring
the
levels
of
the
pesticide
residue
are
not
needed.
Subdivision
M
Series
153A3
a)
indicates
that
``
if
Tier
I
toxicology
tests
indicate
no
toxic
or
other
harmful
properties,
then
no
residue
data
would
be
indicated
and
thus
a
recommendation
for
an
exemption
from
the
requirement
of
a
tolerance
can
be
made.
''
Studies
with
Bacillus
subtilis
var.
amyloliquefaciens
strain
FZB24
demonstrated
low
mammalian
toxicity.
No
pathogenicity
or
infectivity
was
observed
in
any
of
the
tests
conducted
with
Bacillus
subtilis
var.
amyloliquefaciens
strain
FZB24.
Further,
Bacillus
subtilis
var.
amyloliquefaciens
strain
FZB24
is
a
naturally
occurring
microorganism.
Bacillus
subtilis
var.
amyloliquefaciens
is
widespread
in
the
environment.
C.
Mammalian
Toxicological
Profile
Taensa,
Inc.
conducted
the
required
toxicology
studies
to
support
its
petition
for
an
exemption
from
the
requirement
of
tolerance
and
associated
registrations
of
Bacillus
subtilis
var.
amyloliquefaciens
strain
FZB24.
The
studies
conducted
indicate
a
low
mammalian
toxicity
for
Bacillus
subtilis
var.
amyloliquefaciens
strain
FZB24.
No
pathogenicity
or
infectivity
was
observed
in
any
of
the
tests
conducted
with
Bacillus
subtilis
var.
amyloliquefaciens
strain
FZB24.
With
the
exception
of
an
inhalation
study
for
the
end
use
product
(TAEGRO
TM
),
which
is
being
submitted
in
support
of
this
application,
all
toxicology
data
generated
by
Taensa
have
been
reviewed
by
EPA's
Biopesticides
and
Pollution
Prevention
Division
(BPPD).
Toxicology
data
in
support
of
the
exemption
from
the
requirement
of
a
tolerance
for
Bacillus
subtilis
var.
amyloliquefaciens
strain
FZB24
included
studies
with
spores
(technical)
and
with
the
formulated
product
(water
dispersible
powder)
as
follows:
1.
Acute
toxicity
and/
or
pathogenicity—
a.
Bacillus
subtilis
var.
amyloliquefaciens
strain
FZB24
Spores
(Technical):
Acute
oral
toxicity/
pathogenicity
in
rats
``
does
not
appear
to
be
toxic
and/
or
pathogenic
when
dosed
at
1.3
x
10
8
cfu.
''
BPPD
Review
December
20,
1999.
Acute
dermal
toxicity/
pathogenicity
in
rabbits
``
The
severity
of
irritation
persisted
72
h,
and
slight
irritation
persisted
for
10
d,
and
all
resolved
by
day
11.
No
deaths
observed.
The
acute
lethal
dose
(LD50)
is
greater
than
2,000
mg/
kg.
.
.Dermal
irritation
=
Toxicity
II;
Dermal
Toxicity
=
Toxicity
III.
''
BPPD
Review
December
20,
1999.
Acute
pulmonary
toxicity/
pathogenicity
in
rats
``
does
not
appear
to
be
toxic
and/
or
pathogenic
in
rats,
when
dosed
at
1.3
x
10
8
cfu/
animal.
No
total
clearance
is
seen
form
the
lungs
of
treated
test
animals
showed
a
distinct
pattern
of
clearance
from
kidney,
liver,
and
spleen.
''
BPPD
Review
December
20,
1999.
Acute
intravenous
toxicity/
pathogenicity
in
rats
``
does
not
appear
to
be
toxic
and/
or
pathogenic
in
rats,
when
dosed
at
1.7
x
10
8
cfu/
animal.
''
BPPD
Review
December
20,
1999.
Primary
eye
irritation
``
showed
no
signs
of
persistent
irritation
into
day
21,
when
dosed
at
4.7
x
10
10
cfu/
right
eye/
animal.
''
BPPD
Review
December
20,
1999
The
initial
review
indicated
Toxicity
Category
I,
but
was
amended
to
Toxicity
Category
II
(BPPD
Review
March
7,
2000).
Hypersensitivity
testing
``
Based
on
the
submitted
data
does
not
appear
to
be
a
sensitizer
when
dosed
at
3.6
x
10
10
cfu.
''
BPPD
Review
December
20,
1999.
Hypersensitivity
incident
reporting
``
No
recorded
or
reported
hypersensitivity
reaction
based
on
handling
MCPA
in
lab
control
setting,
equating
to
55
person
years.
''
BPPD
Review
December
20,
1999.
Potential
health
effects
``
Based
on
information
given,
there
are
no
apparent
negative
effects
cited
literature
on
B.
Subtilis
indicate
and/
or
support
the
development
as
a
biological
control.
''
BPPD
Review
December
20,
1999.
Growth
parameters
``
is
shown
to
grow
at
all
tested
temperatures
(e.
g.,
30,
34,
37,
and
50
o
C).
The
enumeration
shows
a
low
4.2
x
10
11
cfu/
g
at
37
o
C
to
a
high
6.0
x
10
11
cfu/
g
at
34
o
C.
''
BPPD
Review
December
20,
1999.
b.
Bacillus
subtilis
var.
amyloliquefaciens
strain
FZB24
WDG
(formulation):
Acute
oral
LD50
toxicity
in
rats
``
Toxic/
limit
dose
greater
than
2.8
g/
kg
body
weight
(6.7
x
10
10
cfu/
kg)
Toxicity
Category
III.
''
BPPD
Review
December
20,
1999.
Acute
dermal
LD50
toxicity
in
rats
``
The
severity
of
irritation
persisted
>
72
h,
but
resolved
by
day
11.
No
deaths
observed.
The
acute
dose
(LD50)
is
greater
than
2,000
mg/
kg
Dermal
irritation
=
Toxicity
Category
II;
Dermal
Toxicity
=
Toxicity
Category
III.
''
BPPD
Review
December
20,
1999.
Acute
inhalation
LC50
toxicity
in
rats
(formulation)
``
an
acute
inhalation
medium
lethal
concentration
(LC50)
in
male
and
female
rats
is
greater
than
0.93
mg/
L
Toxicity
Category
II.
''
IIT
Research
Institute
(Document
2
of
this
submission)
Primary
eye
irritation
``
no
corneal
opacity,
and
no
signs
of
irritation
by
day
7,
when
dosed
at
3.6
x
10
10
cfu/
right
eye/
animal
Toxicity
Category
III.
''
BPPD
Review
December
20,
1999.
c.
The
inert
ingredients
contained
in
the
Bacillus
subtilis
var.
amyloliquefaciens
strain
FZB24
formulation,
TAEGRO
TM
are
all
minimal
risk
(List
4).
2.
Genotoxicity.
Subdivision
M
Guidelines
do
not
require
the
conduct
of
genotoxicity
studies
to
support
the
registration
of
a
microbial
pest
control
agent,
such
as
Bacillus
subtilis
var.
amyloliquefaciens
strain
FZB24.
3.
Reproductive
and
developmental
toxicity.
Subdivision
M
Guidelines
do
not
require
the
conduct
of
reproductive
and
developmental
toxicity
studies
to
support
the
registration
of
a
microbial
pest
control
agent,
such
as
Bacillus
subtilis
var.
amyloliquefaciens
strain
FZB24.
4.
Subchronic
toxicity.
Subdivision
M
Guidelines
do
not
require
the
conduct
of
subchronic
toxicity
studies
to
support
the
registration
of
a
microbial
pest
control
agent,
such
as
Bacillus
subtilis
var.
amyloliquefaciens
strain
FZB24.
5.
Chronic
toxicity.
Subdivision
M
Guidelines
do
not
require
the
conduct
of
chronic
toxicity
studies
to
support
the
registration
of
a
microbial
pest
control
agent,
such
as
Bacillus
subtilis
var.
amyloliquefaciens
strain
FZB24.
According
to
Taensa,
Inc.,
sufficient
data
exist
to
assess
the
hazards
of
Bacillus
subtilis
var.
amyloliquefaciens
strain
FZB24
and
to
make
a
determination
on
aggregate
exposure,
consistent
with
section
408(
c)(
2),
for
the
exemptions
from
the
requirement
of
a
tolerance.
The
exposures,
including
dietary
exposure,
and
risks
associated
with
establishing
the
requested
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Vol.
67,
No.
204
/
Tuesday,
October
22,
2002
/
Notices
exemption
from
the
requirement
of
a
tolerance
follows.
D.
Aggregate
Exposure
Bacillus
subtilis
var.
amyloliquefaciens
is
naturally
occurring
and
widespread
in
the
environment.
The
low
toxicity
and
non
pathogenicity/
infectivity
of
Bacillus
subtilis
var.
amyloliquefaciens
strain
FZB24
is
demonstrated
by
the
data
summarized
herein.
The
product
will
be
applied
as
a
seed
treatment
and
via
incorporation,
drenching,
spraying,
dipping,
chemigation
and
hydroponics.
1.
Dietary
exposure—
a.
Food.
It
is
not
anticipated
that
residues
of
Bacillus
subtilis
var.
amyloliquefaciens
strain
FZB24
will
occur
in
treated
raw
agricultural
commodities.
b.
Drinking
water.
It
is
not
anticipated
that
residues
of
Bacillus
subtilis
var.
amyloliquefaciens
strain
FZB24
will
occur
in
drinking
water.
2.
Non
dietary
exposure.
The
potential
for
non
occupational,
nondietary
exposure
to
the
general
population
is
not
expected
to
be
significant.
E.
Cumulative
Exposure
There
is
no
anticipated
potential
for
cumulative
effects
of
Bacillus
subtilis
var.
amyloliquefaciens
strain
FZB24
and
other
substances
that
have
a
common
mode
of
action.
F.
Safety
Determination
1.
U.
S.
population.
Bacillus
subtilis
var.
amyloliquefaciens
strain
FZB24
is
a
naturally
occurring
microorganism.
Bacillus
subtilis
var.
amyloliquefaciens
is
widespread
in
the
environment.
The
low
toxicity
of
Bacillus
subtilis
var.
amyloliquefaciens
strain
FZB24
is
demonstrated
by
the
data
summarized
above.
Based
on
this
information,
the
aggregate
exposure
to
Bacillus
subtilis
var.
amyloliquefaciens
strain
FZB24
over
a
lifetime
should
not
pose
appreciable
risks
to
human
health.
There
is
a
reasonable
certainty
that
no
harm
will
result
from
aggregate
exposure
to
Bacillus
subtilis
var.
amyloliquefaciens
strain
FZB24
residues.
Exempting
Bacillus
subtilis
var.
amyloliquefaciens
strain
FZB24
from
the
requirement
of
a
tolerance
should
be
considered
safe
and
pose
insignificant
risk.
2.
Infants
and
children.
The
toxicity
and
exposure
data
are
sufficiently
complete
to
adequately
address
the
potential
for
additional
sensitivity
of
infants
and
children
to
residues
of
Bacillus
subtilis
var.
amyloliquefaciens
strain
FZB24.
There
is
a
reasonable
certainty
that
no
harm
will
result
to
infants
and
children
from
aggregate
exposure
to
Bacillus
subtilis
var.
amyloliquefaciens
strain
FZB24
residues.
G.
Effects
on
the
Immune
and
Endocrine
Systems
No
specific
tests
have
been
conducted
with
Bacillus
subtilis
var.
amyloliquefaciens
strain
FZB24
to
determine
whether
it
may
have
an
effect
in
humans
that
is
similar
to
an
effect
produced
by
a
naturally
occurring
estrogen
or
other
endocrine
effects.
However,
it
is
not
likely
that
Bacillus
subtilis
var.
amyloliquefaciens
strain
FZB24
would
have
estrogen
or
endocrine
effects
because:
It
is
a
naturally
occurring
microorganism.
Bacillus
subtilis
is
widespread
in
the
environment
It
has
demonstrated
low
mammalian
toxicity.
No
pathogenicity
or
infectivity
was
observed
in
any
of
the
tests
conducted
with
Bacillus
subtilis
var.
amyloliquefaciens
strain
FZB24
The
mechanism
by
which
Bacillus
subtilis
var.
amyloliquefaciens
strain
FZB24
controls
diseases
appears
to
be
via
exudates
Bacillus
subtilis
var.
amyloliquefaciens
strain
FZB24
does
not
produce
toxins
or
antibiotics.
H.
Existing
Tolerances
No
tolerances
or
exemptions
from
the
requirement
of
tolerance
have
been
established
or
applied
for
domestically
or
internationally
other
that
subject
petition.
I.
International
Tolerances
No
maximum
residue
levels
have
been
established
for
Bacillus
subtilis
var.
amyloliquefaciens
strain
FZB24
by
codex
Alimentarius
Commission.
[FR
Doc.
02–
26844
Filed
10–
21–
02;
8:
45
am]
BILLING
CODE
6560–
50–
S
ENVIRONMENTAL
PROTECTION
AGENCY
[FRL–
7396–
9]
Proposed
Modification
of
and
Request
for
Additional
Public
Comment
on
the
General
National
Pollutant
Discharge
Elimination
System
Permits
for
Log
Transfer
Facilities
in
Alaska:
AK–
G70–
0000
and
AK–
G70–
1000
AGENCY:
Environmental
Protection
Agency
(EPA).
ACTION:
Notice
of
proposed
modification
of
and
request
for
additional
public
comments
on
general
NPDES
permits
for
log
transfer
facilities
in
Alaska.
SUMMARY:
The
Director,
Office
of
Water,
EPA
Region
10,
provides
notice
of
and
requests
public
comment
on
proposed
modifications
of
the
two
general
National
Pollutant
Discharge
Elimination
System
(NPDES)
permits
for
Alaskan
log
transfer
facilities
(LTFs),
which
include
log
storage
areas
(LSAs),
that
were
issued
on
March
7,
2000
(65
FR
11999):
NPDES
permit
no.
AK–
G70–
0000,
which
modifies
Clean
Water
Act
(CWA)
section
404
dredge
and
fill
permits
issued
to
LTFs
by
the
U.
S.
Army
Corps
of
Engineers
(ACoE)
prior
to
October
22,
1985,
by
adding
CWA
section
402
effluent
limitations
and
conditions
to
those
permits,
and
NPDES
permit
no.
AK–
G70–
1000,
which
may
cover
all
other
log
transfer
facilities
in
Alaska.
The
EPA
issued
two
general
permits
for
Alaskan
log
transfer
facilities
on
March
7,
2000.
In
response
to
petitions
to
review
the
permits
brought
by
the
Natural
Resources
Defense
Council
and
nine
other
petitioners,
the
United
States
Court
of
Appeals
for
the
Ninth
Circuit,
on
February
13,
2002,
ruled
that
the
EPA
did
not
provide
adequate
notice
of
and
opportunity
to
comment
on
the
general
NPDES
permits
AK–
G70–
0000
and
AK–
G70–
1000
and
remanded
the
permits
to
the
EPA
to
take
further
comment
on
the
project
area
Zone
of
Deposit
(ZOD)
authorized
by
the
Alaska
Department
of
Environmental
Conservation
(ADEC),
and
subsequently
included
in
the
final
permits
by
the
EPA.
To
comply
with
the
Ninth
Circuit's
order,
the
EPA
is
seeking
public
comment
on
the
authorization
of
a
``
project
area''
zone
of
deposit
for
trace,
discontinuous,
and
continuous
coverage
in
the
general
permits.
The
EPA
also
is
proposing
to
modify
these
permits.
The
most
significant
proposal
would
add
a
limit
on
continuous
coverage
within
the
project
area
zone
of
deposit,
but
would
retain
the
project
area
zone
of
deposit
limit
for
bark
and
woody
debris
for
trace,
discontinuous,
and
continuous
coverage
if
less
than
one
acre
and
less
than
10
centimeters
in
depth.
This
notice
seeks
comment
on
the
proposed
major
modifications.
Finally,
the
notice
describes
various
minor
modifications
the
EPA
is
making
to
correct
typographical
errors.
DATES:
Interested
persons
may
submit
written
comments
on
the
proposed
modifications
to
general
NPDES
permits
AK–
G70–
0000
and
AK–
G70–
1000
and
on
the
project
area
zone
of
deposit
on
or
before
December
23,
2002.
ADDRESSES:
Comments
must
be
sent
to
the
attention
of
Alaskan
LTF
Public
Comments,
EPA
Region
10
(OW–
130),
1200
Sixth
Avenue,
Seattle,
WA
98101.
All
comments
should
include
the
name
of
the
commenter,
a
concise
statement
VerDate
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20:
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| epa | 2024-06-07T20:31:43.948505 | regulations | {
"license": "Public Domain",
"url": "https://downloads.regulations.gov/EPA-HQ-OPP-2002-0263-0001/content.txt"
} |
EPA-HQ-OPP-2002-0265-0001 | Notice | "2002-10-10T04:00:00" | FIFRA Scientific Advisory Panel; Notice of Public Meeting: Pre Meeting Teleconference - November
21, 2002. Face-to-Face Meeting: December 3-4, 2002 | 63084
Federal
Register
/
Vol.
67,
No.
197
/
Thursday,
October
10,
2002
/
Notices
numbers
for
EPA's
regulations
are
listed
in
40
CFR
part
9
and
48
CFR
chapter
15.
The
Federal
Register
document
required
under
5
CFR
1320.8(
d),
soliciting
comments
on
this
collection
of
information
was
published
on
January
29,
2002
(67
FR
4253);
one
comment
was
received.
Burden
Statement:
The
annual
public
reporting
and
recordkeeping
burden
for
this
collection
of
information
is
estimated
to
average
25
minutes
per
response.
Burden
means
the
total
time,
effort,
or
financial
resources
expended
by
persons
to
generate,
maintain,
retain,
or
disclose
or
provide
information
to
or
for
a
Federal
agency.
This
includes
the
time
needed
to
review
instructions;
develop,
acquire,
install,
and
utilize
technology
and
systems
for
the
purposes
of
collecting,
validating,
and
verifying
information,
processing
and
maintaining
information,
and
disclosing
and
providing
information;
adjust
the
existing
ways
to
comply
with
any
previously
applicable
instructions
and
requirements;
train
personnel
to
be
able
to
respond
to
a
collection
of
information;
search
data
sources;
complete
and
review
the
collection
of
information;
and
transmit
or
otherwise
disclose
the
information.
Respondents/
Affected
Entities:
Individuals
or
households.
Estimated
Number
of
Respondents:
2350.
Frequency
of
Response:
Once.
Estimated
Total
Annual
Hour
Burden:
979
hours.
Estimated
Total
Annualized
Capital,
O&
M
Cost
Burden:
0.
Send
comments
on
the
Agency's
need
for
this
information,
the
accuracy
of
the
provided
burden
estimates,
and
any
suggested
methods
for
minimizing
respondent
burden,
including
through
the
use
of
automated
collection
techniques
to
the
addresses
listed
above.
Please
refer
to
EPA
ICR
No.
2057.01
in
any
correspondence.
Dated:
October
4,
2002.
Oscar
Morales,
Director,
Collection
Strategies
Division.
[FR
Doc.
02–
25859
Filed
10–
9–
02;
8:
45
am]
BILLING
CODE
6560–
50–
P
ENVIRONMENTAL
PROTECTION
AGENCY
[FRL–
7393–
5]
Investigator
Initiated
Grants:
Request
for
Applications
AGENCY:
Environmental
Protection
Agency
(EPA).
ACTION:
Notice
of
requests
for
applications.
SUMMARY:
This
notice
provides
information
on
the
availability
of
fiscal
year
2003
investigator
initiated
grants
program
announcements,
in
which
the
areas
of
research
interest,
eligibility
and
submission
requirements,
evaluation
criteria,
and
implementation
schedules
are
set
forth.
Grants
will
be
competitively
awarded
following
peer
review.
DATES:
Receipt
dates
vary
depending
on
the
specific
research
areas
within
the
solicitations.
FOR
FURTHER
INFORMATION
CONTACT:
(1)
Technology
for
a
Sustainable
Environment,
karn.
barbara@
epa.
gov,
(2)
Measurement,
modeling
and
analysis
methods
for
airborne
fine
particulate
matter
(PM2.5),
winner.
darrel@
epa.
gov,
(3)
ECOHAB
(Ecology
of
Hazardous
Algal
Blooms),
(4)
Watershed
Classification,
perovich.
gina@
epa.
gov,
and
(5)
Computational
Toxicology
Approaches
for
Endocrine
Disruptors
Screening
Program,
reese.
david@
epa.
gov.
The
complete
program
announcement
can
be
accessed
on
the
Internet
at
http://
www.
epa.
gov/
ncer,
under
``
announcements.
''
The
required
forms
for
applications
with
instructions
are
accessible
on
the
Internet
at
http://
es.
epa.
gov/
ncer/
rfa/
forms/
downlf.
html.
Forms
may
be
printed
from
this
site.
SUPPLEMENTARY
INFORMATION:
In
its
Requests
for
Applications
(RFA)
the
U.
S.
Environmental
Protection
Agency
invites
research
applications
in
the
following
areas
of
special
interest
to
its
mission:
(1)
Technology
for
a
Sustainable
Environment,
(2)
Measurement,
modeling
and
analysis
methods
for
airborne
fine
particulate
matter
(PM2.5),
(3)
ECOHAB
(Ecology
of
Hazardous
Algal
Blooms),
(4)
Watershed
Classification,
and
(5)
Computational
Toxicology
Approaches
for
Endocrine
Disruptors
Screening
Program.
Dated:
October
1,
2002.
John
C.
Puzak,
Acting
Director,
National
Center
for
Environmental
Research.
[FR
Doc.
02–
25863
Filed
10–
9–
02;
8:
45
am]
BILLING
CODE
6560–
50–
P
ENVIRONMENTAL
PROTECTION
AGENCY
[FRL–
7393–
4]
Investigator
Initiated
Grants:
Requests
for
Applications
AGENCY:
Environmental
Protection
Agency
(EPA).
ACTION:
Notice
of
request
for
applications
(RFA).
SUMMARY:
This
notice
provides
information
on
the
availability
of
a
fiscal
year
2003
program
announcement
in
which
areas
of
research
interest,
eligibility
and
submission
requirements,
evaluation
criteria,
and
implementation
schedules
are
set
forth.
DATES:
The
RFA
opened
September
30,
2002
and
closes
January
7,
2003.
FOR
FURTHER
INFORMATION
CONTACT:
April
Richards,
(202)
564–
2297.
Richards.
April@
epa.
gov
or
Bob
Thurnau,
(513)
569–
7504
Thurnau.
Bob@
epa.
gov.
The
complete
program
announcement
can
be
accessed
on
the
Internet
at
http://
www.
epa.
gov/
ncer
under
``
announcements.
''
Unlike
other
EPA
RFAs,
all
necessary
forms
are
included
in
the
RFA.
SUPPLEMENTARY
INFORMATION:
In
its
Requests
for
Applications
the
U.
S.
Environmental
Protection
Agency
invites
research
applications
in
the
following
are
of
special
interest
to
its
mission:
Treatment
Technologies
for
Arsenic
Removal
for
Small
Drinking
Water
Systems:
Request
for
Applications.
The
objective
of
this
program
is
to
pre
qualify
treatment
technologies
for
a
subsequent
demonstration
program
which
will
evaluate
the
efficiency
and
effectiveness
of
drinking
water
treatment
technologies
to
meet
the
new
arsenic
maximum
contaminant
level
(MCL)
of
0.01
mg/
l
for
varying
source
water
quality
conditions.
Proposals
selected
under
this
competition
will
be
pre
qualified
for
demonstration
projects
at
selected
utilities
throughout
the
country.
Dated:
September
30,
2002.
John
C.
Puzak,
Acting
Director,
National
Center
for
Environmental
Research.
[FR
Doc.
02–
25864
Filed
10–
9–
02;
8:
45
am]
BILLING
CODE
6560–
50–
P
ENVIRONMENTAL
PROTECTION
AGENCY
[OPP–
2002–
0265;
FRL–
7276–
4]
FIFRA
Scientific
Advisory
Panel;
Notice
of
Public
Meetings
AGENCY:
Environmental
Protection
Agency
(EPA).
ACTION:
Notice.
SUMMARY:
There
will
be
a
public
premeeting
teleconference
and
a
3–
day
face
to
face
meeting
of
the
Federal
Insecticide,
Fungicide,
and
Rodenticide
Act
Scientific
Advisory
Panel
(FIFRA
SAP)
to
consider
and
review
studies
on
water
disinfection
and
softening
as
related
to
the
Food
Quality
Protection
VerDate
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02>
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23:
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09,
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63085
Federal
Register
/
Vol.
67,
No.
197
/
Thursday,
October
10,
2002
/
Notices
Act
of
1996
(FQPA)
drinking
water
exposure
assessments.
DATES:
Pre
meeting
teleconference:
November
21,
2002,
from
1
p.
m.
to
3
p.
m,
eastern
standard
time.
Face
to
face
meetings:
December
3–
5,
2002,
from
8:
30
a.
m.
to
5
p.
m,
eastern
standard
time.
Comments:
For
deadlines
for
submission
of
requests
to
present
oral
comments
and
submission
of
written
comments,
see
Unit
I.
E.
of
the
SUPPLEMENTARY
INFORMATION.
Nominations:
Requests
for
nominations
to
serve
as
an
ad
hoc
member
of
the
FIFRA
SAP
for
the
premeeting
teleconference
and
face
to
face
meetings
should
be
provided
on
or
before
October
25,
2002.
Special
seating:
Requests
for
special
seating
arrangements
should
be
made
at
least
5
business
days
prior
to
the
meeting.
ADDRESSES:
Pre
meeting
teleconference:
This
meeting
will
be
held
at
the
Environmental
Protection
Agency,
EPA
East
Bldg.,
1201
Constitution
Ave.,
NW.,
Conference
Room
4225,
Washington,
DC.
For
additional
information
about
the
pre
meeting
teleconference,
including
how
to
receive
the
teleconference
telephone
number,
contact
the
Designated
Federal
Official
(DFO)
listed
under
FOR
FURTHER
INFORMATION
CONTACT.
To
ensure
proper
receipt
by
EPA,
your
request
must
identify
docket
ID
number
OPP–
2002–
0265
in
the
subject
line
on
the
first
page
of
your
response.
Face
to
face
meetings:
These
meetings
will
be
held
at
the
Sheraton
Crystal
City
Hotel,
1800
Jefferson
Davis
Hwy.,
Arlington,
VA.
The
telephone
number
for
the
Sheraton
Crystal
City
Hotel
is
(703)
486–
1111.
Comments:
Written
comments
may
be
submitted
electronically,
by
mail,
or
through
hand
delivery/
courier.
Follow
the
detailed
instructions
as
provided
in
Unit
I.
of
the
SUPPLEMENTARY
INFORMATION.
Nominations,
Requests
to
present
oral
comments,
and
Special
seating:
To
submit
nominations
to
serve
as
an
ad
hoc
member
of
the
FIFRA
SAP
for
the
face
to
face
meetings
and
pre
meeting
teleconference,
or
requests
for
special
seating
arrangements,
or
requests
to
present
oral
comments,
notify
the
DFO
listed
under
FOR
FURTHER
INFORMATION
CONTACT.
To
ensure
proper
receipt
by
EPA,
your
request
must
identify
docket
ID
number
OPP–
2002–
0265
in
the
subject
line
on
the
first
page
of
your
response.
FOR
FURTHER
INFORMATION
CONTACT:
Paul
Lewis,
DFO,
Office
of
Science
Coordination
and
Policy
(7202M),
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460–
0001;
telephone
number:
(202)
564–
8450;
fax
number:
(202)
564–
8382;
e
mail
address:
lewis.
paul@
epa.
gov.
SUPPLEMENTARY
INFORMATION:
I.
General
Information
A.
Does
this
Action
Apply
to
Me?
This
action
is
directed
to
the
public
in
general.
This
action
may,
however,
be
of
interest
to
persons
who
are
or
may
be
required
to
conduct
testing
of
chemical
substances
under
the
Federal
Food,
Drug,
and
Cosmetic
Act
(FFDCA),
FIFRA,
and
FQPA.
Since
other
entities
may
also
be
interested,
the
Agency
has
not
attempted
to
describe
all
the
specific
entities
that
may
be
affected
by
this
action.
If
you
have
any
questions
regarding
the
applicability
of
this
action
to
a
particular
entity,
consult
the
DFO
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–
0265.
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
meeting
agenda
relevant
to
these
meetings
is
now
available.
EPA's
position
paper,
questions
to
FIFRA
SAP,
and
FIFRA
SAP
composition
(i.
e.,
members
and
consultants
for
this
meeting)
will
be
available
as
soon
as
possible,
but
no
later
than
early
November.
In
addition,
the
Agency
may
provide
additional
background
documents
as
the
materials
become
available.
You
may
obtain
electronic
copies
of
these
documents,
and
certain
other
related
documents
that
might
be
available
electronically,
from
the
FIFRA
SAP
Internet
Home
Page
at
http://
www.
epa.
gov/
scipoly/
sap.
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.
Certain
types
of
information
will
not
be
placed
in
the
EPA
Dockets.
Information
claimed
as
CBI
and
other
information
whose
disclosure
is
restricted
by
statute,
which
is
not
included
in
the
official
public
docket,
will
not
be
available
for
public
viewing
in
EPA's
electronic
public
docket.
EPA's
policy
is
that
copyrighted
material
will
not
be
placed
in
EPA's
electronic
public
docket
but
will
be
available
only
in
printed,
paper
form
in
the
official
public
docket.
To
the
extent
feasible,
publicly
available
docket
materials
will
be
made
available
in
EPA's
electronic
public
docket.
When
a
document
is
selected
from
the
index
list
in
EPA
Dockets,
the
system
will
identify
whether
the
document
is
available
for
viewing
in
EPA's
electronic
public
docket.
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.
EPA
intends
to
work
towards
providing
electronic
access
to
all
of
the
publicly
available
docket
materials
through
EPA's
electronic
public
docket.
For
public
commenters,
it
is
important
to
note
that
EPA's
policy
is
that
public
comments,
whether
submitted
electronically
or
in
paper,
will
be
made
available
for
public
viewing
in
EPA's
electronic
public
docket
as
EPA
receives
them
and
without
change,
unless
the
comment
contains
copyrighted
material,
CBI,
or
other
information
whose
disclosure
is
restricted
by
statute.
When
EPA
identifies
a
comment
containing
copyrighted
material,
EPA
will
provide
a
reference
to
that
material
in
the
version
of
the
comment
that
is
placed
in
EPA's
electronic
public
docket.
The
entire
printed
comment,
including
the
copyrighted
material,
will
be
available
in
the
public
docket.
Public
comments
submitted
on
computer
disks
that
are
mailed
or
delivered
to
the
docket
will
be
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Notices
transferred
to
EPA's
electronic
public
docket.
Public
comments
that
are
mailed
or
delivered
to
the
docket
will
be
scanned
and
placed
in
EPA's
electronic
public
docket.
Where
practical,
physical
objects
will
be
photographed,
and
the
photograph
will
be
placed
in
EPA's
electronic
public
docket
along
with
a
brief
description
written
by
the
docket
staff.
C.
How
and
To
Whom
Do
I
Submit
Comments?
You
may
submit
comments
electronically,
by
mail,
or
through
hand
delivery/
courier.
To
ensure
proper
receipt
by
EPA,
identify
the
appropriate
docket
ID
number
in
the
subject
line
on
the
first
page
of
your
comment.
Please
ensure
that
your
comments
are
submitted
within
the
specified
comment
period.
Comments
received
after
the
close
of
the
comment
period
will
be
marked
``
late.
''
EPA
is
not
required
to
consider
these
late
comments.
If
you
wish
to
submit
CBI
or
information
that
is
otherwise
protected
by
statute,
please
follow
the
instructions
in
Unit
I.
D.
Do
not
use
EPA
Dockets
or
e
mail
to
submit
CBI
or
information
protected
by
statute.
1.
Electronically.
If
you
submit
an
electronic
comment
as
prescribed
in
this
unit,
EPA
recommends
that
you
include
your
name,
mailing
address,
and
an
email
address
or
other
contact
information
in
the
body
of
your
comment.
Also
include
this
contact
information
on
the
outside
of
any
disk
or
CD
ROM
you
submit,
and
in
any
cover
letter
accompanying
the
disk
or
CD
ROM.
This
ensures
that
you
can
be
identified
as
the
submitter
of
the
comment
and
allows
EPA
to
contact
you
in
case
EPA
cannot
read
your
comment
due
to
technical
difficulties
or
needs
further
information
on
the
substance
of
your
comment.
EPA's
policy
is
that
EPA
will
not
edit
your
comment,
and
any
identifying
or
contact
information
provided
in
the
body
of
a
comment
will
be
included
as
part
of
the
comment
that
is
placed
in
the
official
public
docket,
and
made
available
in
EPA's
electronic
public
docket.
If
EPA
cannot
read
your
comment
due
to
technical
difficulties
and
cannot
contact
you
for
clarification,
EPA
may
not
be
able
to
consider
your
comment.
i.
EPA
Dockets.
Your
use
of
EPA's
electronic
public
docket
to
submit
comments
to
EPA
electronically
is
EPA's
preferred
method
for
receiving
comments.
Go
directly
to
EPA
Dockets
at
http://
www.
epa.
gov/
edocket,
and
follow
the
online
instructions
for
submitting
comments.
Once
in
the
system,
select
``
search,
''
and
then
key
in
docket
ID
number
OPP–
2002–
0265.
The
system
is
an
``
anonymous
access''
system,
which
means
EPA
will
not
know
your
identity,
e
mail
address,
or
other
contact
information
unless
you
provide
it
in
the
body
of
your
comment.
ii.
E
mail.
Comments
may
be
sent
by
e
mail
to
opp
docket@
epa.
gov,
Attention:
Docket
ID
Number
OPP–
2002–
0265.
In
contrast
to
EPA's
electronic
public
docket,
EPA's
e
mail
system
is
not
an
``
anonymous
access''
system.
If
you
send
an
e
mail
comment
directly
to
the
docket
without
going
through
EPA's
electronic
public
docket,
EPA's
e
mail
system
automatically
captures
your
e
mail
address.
E
mail
addresses
that
are
automatically
captured
by
EPA's
e
mail
system
are
included
as
part
of
the
comment
that
is
placed
in
the
official
public
docket,
and
made
available
in
EPA's
electronic
public
docket.
iii.
Disk
or
CD
ROM.
You
may
submit
comments
on
a
disk
or
CD
ROM
that
you
mail
to
the
mailing
address
identified
in
Unit
I.
C.
2.
These
electronic
submissions
will
be
accepted
in
WordPerfect
or
ASCII
file
format.
Avoid
the
use
of
special
characters
and
any
form
of
encryption.
2.
By
mail.
Send
your
comments
to:
Public
Information
and
Records
Integrity
Branch
(PIRIB)
(7502C),
Office
of
Pesticide
Programs
(OPP),
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460–
0001,
Attention:
Docket
ID
Number
OPP–
2002–
0265.
3.
By
hand
delivery
or
courier.
Deliver
your
comments
to:
Public
Information
and
Records
Integrity
Branch
(PIRIB),
Office
of
Pesticide
Programs
(OPP),
Environmental
Protection
Agency,
Rm.
119,
Crystal
Mall
#2,
1921
Jefferson
Davis
Hwy.,
Arlington,
VA,
Attention:
Docket
ID
Number
OPP–
2002–
0265.
Such
deliveries
are
only
accepted
during
the
docket's
normal
hours
of
operation
as
identified
in
Unit
I.
B.
1.
D.
How
Should
I
Submit
CBI
to
the
Agency?
Do
not
submit
information
that
you
consider
to
be
CBI
electronically
through
EPA's
electronic
public
docket
or
by
e
mail.
You
may
claim
information
that
you
submit
to
EPA
as
CBI
by
marking
any
part
or
all
of
that
information
as
CBI
(if
you
submit
CBI
on
disk
or
CD
ROM,
mark
the
outside
of
the
disk
or
CD
ROM
as
CBI
and
then
identify
electronically
within
the
disk
or
CD
ROM
the
specific
information
that
is
CBI).
Information
so
marked
will
not
be
disclosed
except
in
accordance
with
procedures
set
forth
in
40
CFR
part
2.
In
addition
to
one
complete
version
of
the
comment
that
includes
any
information
claimed
as
CBI,
a
copy
of
the
comment
that
does
not
contain
the
information
claimed
as
CBI
must
be
submitted
for
inclusion
in
the
public
docket
and
EPA's
electronic
public
docket.
If
you
submit
the
copy
that
does
not
contain
CBI
on
disk
or
CD
ROM,
mark
the
outside
of
the
disk
or
CD
ROM
clearly
that
it
does
not
contain
CBI.
Information
not
marked
as
CBI
will
be
included
in
the
public
docket
and
EPA's
electronic
public
docket
without
prior
notice.
If
you
have
any
questions
about
CBI
or
the
procedures
for
claiming
CBI,
please
consult
the
person
listed
under
FOR
FURTHER
INFORMATION
CONTACT.
E.
How
May
I
Participate
in
These
Meetings?
Requests
to
present
oral
comments,
written
comments,
or
requests
for
special
seating
arrangements
may
be
submitted
electronically,
by
mail,
or
through
hand
delivery/
courier.
(See
Units
I.
C.
D.)
Do
not
submit
any
information
in
your
request
that
is
considered
CBI.
To
ensure
proper
receipt
by
EPA,
it
is
imperative
that
you
identify
docket
ID
number
OPP–
2002–
0265
in
the
subject
line
on
the
first
page
of
your
request.
1.
Oral
comments.
Oral
comments
presented
at
the
meetings
should
not
be
repetitive
of
previously
submitted
oral
or
written
comments.
Although
requests
to
present
oral
comments
are
accepted
until
the
date
of
the
meeting
(unless
otherwise
stated),
to
the
extent
that
time
permits,
interested
persons
may
be
permitted
by
the
Chair
of
FIFRA
SAP
to
present
oral
comments
at
the
meeting.
Each
individual
or
group
wishing
to
make
brief
oral
comments
to
FIFRA
SAP
is
strongly
advised
to
submit
their
request
to
the
DFO
listed
under
FOR
FURTHER
INFORMATION
CONTACT
no
later
than
noon,
eastern
standard
time,
November
14,
2002,
for
the
pre
meeting
teleconference
or
no
later
than
noon,
eastern
standard
time,
November
25,
2002,
for
the
face
to
face
meetings
in
order
to
be
included
on
the
meeting
agenda.
The
request
should
identify
the
name
of
the
individual
making
the
presentation
and
the
organization
(if
any)
the
individual
will
represent.
In
addition,
any
requirements
for
audiovisual
equipment
(e.
g.,
overhead
projector,
35
mm
projector,
chalkboard)
at
the
face
to
face
meetings
should
be
requested
at
this
time.
Oral
comments
before
the
FIFRA
SAP
are
limited
to
approximately
5
minutes
unless
prior
arrangements
have
been
made.
In
addition,
each
speaker
should
bring
30
copies
of
his
or
her
comments
and
presentation
slides
to
the
face
to
face
meeting.
2.
Written
comments.
Although
submission
of
written
comments
are
accepted
until
the
date
of
the
meeting
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Notices
(unless
otherwise
stated),
the
Agency
encourages
that
written
comments
be
submitted
no
later
than
noon,
eastern
standard
time,
November
14,
2002,
for
the
pre
meeting
teleconference
or
no
later
than
noon,
eastern
standard
time,
November
25,
2002,
for
the
face
to
face
meetings,
to
provide
the
FIFRA
SAP
the
time
necessary
to
consider
and
review
the
written
comments.
There
is
no
limit
on
the
extent
of
written
comments
for
consideration
by
FIFRA
SAP.
Persons
wishing
to
submit
written
comments
at
the
meeting
should
contact
the
DFO
listed
under
FOR
FURTHER
INFORMATION
CONTACT
and
submit
30
copies.
3.
Seating
at
the
meetings.
Seating
at
both
meetings
will
be
on
a
first
come
basis.
Individuals
requiring
special
accommodations
at
this
meeting,
including
wheelchair
access,
should
contact
the
DFO
at
least
5
business
days
prior
to
the
meeting
using
the
information
under
FOR
FURTHER
INFORMATION
CONTACT
so
that
appropriate
arrangements
can
be
made.
II.
Background
A.
Purpose
of
the
FIFRA
SAP
Pursuant
to
the
Federal
Advisory
Committee
Act,
Public
Law
92–
463,
notice
is
hereby
given
of
two
meetings
of
the
EPA
FIFRA
SAP.
Amendments
to
FIFRA
enacted
November
28,
1975
(7
U.
S.
C.
136w(
d)),
include
a
requirement
under
section
25(
d)
of
FIFRA
that
notices
of
intent
to
cancel
or
reclassify
pesticide
regulations
pursuant
to
section
6(
b)(
2)
of
FIFRA,
as
well
as
proposed
and
final
forms
of
rulemaking
pursuant
to
section
25(
a)
of
FIFRA,
be
submitted
to
a
SAP
prior
to
being
made
public
or
issued
to
a
registrant.
In
accordance
with
section
25(
d)
of
FIFRA,
the
FIFRA
SAP
is
to
have
an
opportunity
to
comment
on
the
health
and
environmental
impact
of
such
actions.
The
FIFRA
SAP
also
shall
make
comments,
evaluations,
and
recommendations
for
operating
guidelines
to
improve
the
effectiveness
and
quality
of
analyses
made
by
Agency
scientists.
Members
are
scientists
who
have
sufficient
professional
qualifications,
including
training
and
experience,
to
be
capable
of
providing
expert
comments
as
to
the
impact
on
health
and
the
environment
of
regulatory
actions
under
sections
6(
b)
and
25(
a)
of
FIFRA.
The
Deputy
Administrator
appoints
seven
individuals
to
serve
on
the
FIFRA
SAP
for
staggered
terms
of
4
years,
based
on
recommendations
from
the
National
Institutes
of
Health
and
the
National
Science
Foundation.
Section
104
of
FQPA
(Public
Law
104–
170)
established
the
FQPA
Science
Review
Board
(SRB).
These
scientists
shall
be
available
to
the
FIFRA
SAP
on
an
ad
hoc
basis
to
assist
in
reviews
conducted
by
the
FIFRA
SAP.
B.
Pre
meeting
Teleconference
The
FIFRA
SAP
will
meet
on
November
21,
2002,
via
teleconference
from
1
p.
m.
to
3
p.
m.,
eastern
standard
time.
This
teleconference
meeting
will
be
hosted
out
of
Conference
Room
4225,
Environmental
Protection
Protection,
EPA
East
Bldg.,
1201
Constitution
Ave.,
NW.,
Washington,
DC.
The
meeting
is
open
to
the
public
and
seating
will
be
on
a
first
come
basis.
The
public
may
also
attend
via
telephone.
For
further
information
concerning
the
meeting
or
how
to
obtain
the
telephone
number,
please
contact
the
DFO
listed
under
FOR
FURTHER
INFORMATION
CONTACT.
The
purpose
of
this
public
premeeting
teleconference
is
to:
1.
Discuss
the
charge
and
the
adequacy
of
the
review
materials
provided
to
the
FIFRA
SAP.
2.
Clarify
any
questions
and
issues
relating
to
the
charge
and
the
review
materials.
3.
Discuss
specific
charge
assignments
to
the
Panelists.
4.
Clarify
specific
points
of
interest
raised
by
the
Panelists
in
preparation
for
the
face
to
face
meetings
to
be
held
on
December
3,
December
4,
and
December
5,
2002.
C.
Face
to
Face
Public
Meetings
On
December
3–
5,
2002,
the
Agency
will
be
continuing
its
consultation
with
the
FIFRA
SAP
to
review
studies
on
water
disinfection
and
softening
as
related
to
FQPA
drinking
water
exposure
assessments.
On
September
29,
2000,
the
Agency
updated
the
FIFRA
SAP
on
their
progress
in
improving
its
drinking
water
assessment
process.
In
addition,
the
Agency
presented
a
review
of
the
scientific
literature
on
the
impacts
of
drinking
water
treatment
on
the
removal
and
transformation
of
pesticides.
In
their
recommendations,
the
FIFRA
SAP
supported
the
Agency's
efforts
to
better
understand
the
effects
of
water
treatment
on
pesticides
and
encouraged
the
Agency
to
return
to
the
FIFRA
SAP
to
report
on
its
progress
in
developing
approaches
that
factor
treatment
into
drinking
water
exposure
assessments.
Since
the
previous
meeting,
the
Agency
has
reviewed
additional
pesticide
laboratory
and
field
monitoring
studies
plus
new
information
on
the
effects
of
drinking
water
treatment
processes
on
pesticide
removal
and
transformation.
In
addition,
the
Agency
has
developed
a
proposed
laboratory
protocol
to
determine
the
effects
of
individual
and
combined
drinking
water
treatment
processes
on
pesticide
removal
and
transformation.
The
purpose
of
this
consultation
is
to
update
the
Panel
on
the
Agency's
efforts
to
identify
various
U.
S.
drinking
water
treatment
processes
and
to
present
laboratory
studies
and
field
monitoring
studies
that
consider
treatment
effects
on
pesticides.
The
Agency
will
also
present
a
proposed
laboratory
protocol
for
determining
the
effects
of
treatment
on
pesticide
removal
and
transformation
plus
a
plan
for
testing
the
protocol
design
and
implementation.
For
this
consultation,
the
Panel
will
review:
1.
The
Agency's
progress
report
on
effects
of
treatment
processes
on
the
levels
and
stability
of
pesticides
in
community
water
systems
and;
2.
The
Agency's
proposed
laboratory
protocol
for
assessing
water
treatment
effects.
D.
Request
for
Nominations
to
Serve
as
Ad
Hoc
Members
of
the
FIFRA
SAP
for
These
Meetings
The
FIFRA
SAP
staff
routinely
solicit
the
stakeholder
community
for
nominations
to
serve
as
ad
hoc
members
of
the
FIFRA
SAP
for
each
meeting.
Any
interested
person
or
organization
may
nominate
qualified
individuals
to
serve
on
the
FIFRA
SAP
for
a
specific
meeting.
No
interested
person
shall
be
ineligible
to
serve
by
reason
of
their
membership
on
any
other
advisory
committee
to
a
Federal
Department
or
Agency
or
their
employment
by
a
Federal
Department
or
Agency
(except
the
EPA).
Individuals
nominated
should
have
expertise
in
one
or
more
of
the
following
areas:
Water
treatment,
chemical
oxidation,
water
quality
assessment,
and
drinking
water
risk
assessment.
Nominees
should
be
scientists
who
have
sufficient
professional
qualifications,
including
training
and
experience,
to
be
capable
of
providing
expert
comments
on
the
issues
for
this
meeting.
Nominees
should
be
identified
by
name,
occupation,
position,
address,
and
telephone
number.
Nominations
should
be
provided
to
the
DFO
listed
under
FOR
FURTHER
INFORMATION
CONTACT
by
October
25,
2002.
The
criteria
for
selecting
scientists
to
serve
on
the
FIFRA
SAP
are
that
these
persons
be
recognized
scientists—
experts
in
their
fields;
that
they
be
as
impartial
and
objective
as
possible;
that
they
represent
an
array
of
backgrounds
and
perspectives
(within
their
disciplines);
have
no
financial
conflict
of
interest;
have
not
previously
been
involved
with
the
scientific
peer
review
of
the
issue(
s)
presented;
and
that
they
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/
Vol.
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No.
197
/
Thursday,
October
10,
2002
/
Notices
be
available
to
participate
fully
in
the
review,
which
will
be
conducted
over
a
relatively
short
time
frame.
Nominees
will
be
asked
to
attend
the
public
meetings
and
to
participate
in
the
discussion
of
key
issues
and
assumptions
at
these
meetings.
Finally,
they
will
be
asked
to
review
and
to
help
finalize
the
meeting
minutes.
If
a
FIFRA
SAP
nominee
is
considered
to
assist
in
a
review
by
the
FIFRA
SAP
for
a
particular
session,
the
nominee
is
subject
to
the
provisions
of
5
CFR
part
2634,
Executive
Branch
Financial
Disclosure,
as
supplemented
by
the
EPA
in
5
CFR
part
6401.
As
such,
the
FIFRA
SAP
nominee
is
required
to
submit
a
Confidential
Financial
Disclosure
Report
which
shall
fully
disclose,
among
other
financial
interests,
the
nominee's
employment,
stocks
and
bonds,
and
where
applicable,
sources
of
research
support.
EPA
will
evaluate
the
nominee's
financial
disclosure
form
to
assess
that
there
are
no
formal
conflict
of
interests
before
the
nominee
is
considered
to
serve
on
the
FIFRA
SAP.
Selected
FIFRA
SAP
members
will
be
hired
as
a
Special
Government
Employee.
The
Agency
will
review
all
nominations;
a
decision
on
FIFRA
SAP
members
for
the
meeting
will
be
posted
on
the
FIFRA
SAP
web
site
or
may
be
obtained
by
contacting
the
PIRIB
at
the
address
or
telephone
number
listed
in
Unit
I.
E.
FIFRA
SAP
Meeting
Minutes
The
FIFRA
SAP
will
prepare
meeting
minutes
summarizing
its
recommendations
to
the
Agency
in
approximately
60
days.
The
meeting
minutes
will
be
posted
on
the
FIFRA
SAP
web
site
or
may
be
obtained
by
contacting
the
PIRIB
at
the
address
or
telephone
number
listed
in
Unit
I.
List
of
Subjects
Environmental
protection,
Pesticides
and
pests.
Dated:
October
3,
2002.
Joseph
J.
Merenda,
Jr.,
Director,
Office
of
Science
Coordination
and
Policy.
[FR
Doc.
02–
25860
Filed
10–
9–
02;
8:
45
am]
BILLING
CODE
6560–
50–
S
ENVIRONMENTAL
PROTECTION
AGENCY
[OPPT–
2002–
0052;
FRL–
7276–
3]
Forum
on
State
and
Tribal
Toxics
Action;
Notice
of
Public
Meeting
AGENCY:
Environmental
Protection
Agency
(EPA).
ACTION:
Notice.
SUMMARY:
EPA
is
announcing
the
fall
meeting
of
the
Forum
on
State
and
Tribal
Toxics
Action
(FOSTTA)
to
collaborate
on
environmental
protection
and
chemical
and
prevention
issues.
The
Chemical
Information
and
Management,
Pollution
Prevention,
Toxics
Release
Inventory,
and
Tribal
Affairs
Projects,
components
of
FOSTTA,
will
hold
meetings
October
21–
22,
2002.
This
notice
announces
the
location
and
times
for
the
meetings
and
sets
forth
some
tentative
agenda
topics.
EPA
invites
all
interested
parties
to
attend
the
public
meetings.
DATES:
The
four
projects
will
meet
concurrently
October
21,
2002,
from
10
a.
m.
to
5
p.
m.,
and
October
22,
2002,
from
8
a.
m.
to
noon.
A
plenary
session
is
being
planned
for
the
participants
on
Monday,
October
21,
2002,
from
8
a.
m.
to
9:
30
a.
m.
Requests
to
participate
in
the
fall
FOSTTA
meeting,
identified
by
docket
ID
number
OPPT–
2002–
0052,
must
be
received
by
EPA
on
or
before
October
11,
2002.
ADDRESSES:
The
meetings
will
be
held
at
the
Hall
of
States,
444
North
Capitol
Street,
NW.,
Washington,
DC.
The
building
is
located
across
from
the
Union
Station
metro
stop
on
the
red
line.
Requests
to
participate
in
the
meeting
may
be
submitted
to
Christine
Eppstein,
listed
under
FOR
FURTHER
INFORMATION
CONTACT.
FOR
FURTHER
INFORMATION
CONTACT:
For
general
information
contact:
Barbara
Cunningham,
Acting
Director,
Environmental
Assistance
Division
(7408M),
Office
of
Pollution
Prevention
and
Toxics,
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460–
0001;
telephone
number:
(202)
554–
1404;
e
mail
address:
TSCA
Hotline@
epa.
gov.
For
technical
information
contact:
Darlene
Harrod,
Environmental
Assistance
Division
(7408M),
Office
of
Pollution
Prevention
and
Toxics,
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460–
0001;
telephone
number:
(202)
564–
8814;
fax
number:
(202)
564–
8813;
e
mail
address:
harrod.
darlene@
epa.
gov.
Christine
Eppstein,
Environmental
Council
of
the
States,
444
North
Capitol
Street,
NW.,
Suite
445,
Washington,
DC
20001;
telephone
number:
(202)
624–
3661;
fax
number:
(202)
624–
3666;
email
address:
ceppstein@
sso.
org.
SUPPLEMENTARY
INFORMATION:
I.
Does
this
Action
Apply
to
Me?
You
may
be
potentially
affected
by
this
action
if
you
are
interested
in
FOSTTA
and
hearing
more
about
the
perspectives
of
the
states
and
tribes
on
EPA
programs
and
information
exchange
regarding
important
issues
related
to
human
health
and
environmental
exposure
to
toxics.
Potentially
affected
entities
may
include,
but
are
not
limited
to:
States
and
federally
recognized
tribes.
State,
Federal,
and
local
environmental
and
public
health
organizations.
Chemical
trade
associations.
The
listing
is
not
intended
to
be
exhaustive,
but
rather
provides
a
guide
for
readers
regarding
entities
likely
to
be
affected
by
this
action.
If
you
have
any
questions
regarding
the
applicability
of
this
action
to
a
particular
entity,
consult
the
technical
persons
listed
under
FOR
FURTHER
INFORMATION
CONTACT.
II.
How
Can
I
Get
Copies
of
this
Document
and
Other
Related
Documents?
1.
Docket.
EPA
has
established
an
official
public
docket
for
this
action
under
docket
ID
number
OPPT–
2002–
0052.
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
EPA
Docket
Center,
Rm.
B102–
Reading
Room,
EPA
West,
1301
Constitution
Ave.,
NW.,
Washington,
DC.
The
EPA
Docket
Center
is
open
from
8:
30
a.
m.
to
4:
30
p.
m.,
Monday
through
Friday,
excluding
legal
holidays.
The
EPA
Docket
Center
Reading
Room
telephone
number
is
(202)
566–
1744
and
the
telephone
number
for
the
OPPT
Docket,
which
is
located
in
EPA
Docket
Center,
is
(202)
566–
0280.
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/.
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
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"url": "https://downloads.regulations.gov/EPA-HQ-OPP-2002-0265-0001/content.txt"
} |
EPA-HQ-OPP-2002-0265-0002 | Notice | "2002-11-13T05:00:00" | FIFRA Scientific Advisory Panel; Notice of Cancellation of Public Meetings | 68863
Federal
Register
/
Vol.
67,
No.
219
/
Wednesday,
November
13,
2002
/
Notices
in
40
CFR
part
9
and
48
CFR
chapter
15.
The
Federal
Register
document
required
under
5
CFR
1320.8(
d),
soliciting
comments
on
this
collection
of
information
was
published
on
June
20,
2002.
No
comments
were
received.
Burden
Statement:
The
annual
public
reporting
and
recordkeeping
burden
for
this
collection
of
information
is
estimated
to
average
36
hours
per
response.
Burden
means
the
total
time,
effort,
or
financial
resources
expended
by
persons
to
generate,
maintain,
retain,
or
disclose
or
provide
information
to
or
for
a
Federal
agency.
This
includes
the
time
needed
to
review
instructions;
develop,
acquire,
install,
and
utilize
technology
and
systems
for
the
purposes
of
collecting,
validating,
and
verifying
information,
processing
and
maintaining
information,
and
disclosing
and
providing
information;
adjust
the
existing
ways
to
comply
with
any
previously
applicable
instructions
and
requirements;
train
personnel
to
respond
to
a
collection
of
information;
search
data
sources;
complete
and
review
the
collection
of
information;
and
transmit
or
otherwise
disclose
the
information.
Respondents/
Affected
Entities:
Owners/
Operators
of
Metal
Coil
Surface
Coating
Plants.
Estimated
Number
of
Respondents:
165.
Frequency
of
Response:
semiannual
for
all,
every
other
year
for
excess
emission
report.
Estimated
Total
Annual
Hour
Burden:
14,531.
Estimated
Total
Annualized
Capital,
O&
M
Cost
Burden:
$
318,000.
Send
comments
on
the
Agency's
need
for
this
information,
the
accuracy
of
the
provided
burden
estimates,
and
any
suggested
methods
for
minimizing
respondent
burden,
including
through
the
use
of
automated
collection
techniques
to
the
addresses
listed
above.
Please
refer
to
EPA
ICR
Number
0660.08
and
OMB
Control
Number
2060
0107
in
any
correspondence.
Dated:
November
4,
2002.
Oscar
Morales,
Director,
Collection
Strategies
Division.
[
FR
Doc.
02
28849
Filed
11
2
02;
8:
45
am]
BILLING
CODE
6560
50
P
ENVIRONMENTAL
PROTECTION
AGENCY
[
FRL
7407
9]
Proposed
Settlement
Agreement
AGENCY:
Environmental
Protection
Agency.
ACTION:
Notice
of
proposed
settlement
agreement;
request
for
public
comment.
SUMMARY:
In
accordance
with
section
113(
g)
of
the
Clean
Air
Act,
as
amended,
42
U.
S.
C.
7413(
g),
notice
is
hereby
given
of
a
proposed
settlement
agreement
in
Utility
Air
Regulatory
Group
(
UARG)
v.
Environmental
Protection
Agency
(
EPA),
No.
02
1023
and
consolidated
cases
(
Nos.
02
1026,
02
1027,
02
1028,
02
1088)(
D.
C.
Circuit).
These
consolidated
cases
concern
a
November
15,
2001
Federal
Register
notice
entitled
Recent
Posting
of
Agency
Regulatory
Interpretations
Pertaining
to
Applicability
and
Monitoring
for
Standards
of
Performance
for
New
Stationary
Sources
and
National
Emission
Standards
for
Hazardous
Air
Pollutants
to
the
Applicability
Index
(
ADI)
Database
System,
(
66
FR
57453)
and
a
January
10,
2002
Federal
Register
notice
entitled
Recent
Posting
to
the
Applicability
Determination
Index
(
ADI)
Database
System
of
Agency
Applicability
Determinations,
Alternative
Monitoring
Decisions,
and
Regulatory
Interpretations
Pertaining
to
Standards
of
Performance
for
New
Stationary
Sources
and
National
Emission
Standards
for
Hazardous
Air
Pollutants,
(
67
FR
1295).
DATES:
Written
comments
on
the
proposed
settlement
agreement
must
be
received
by
December
13,
2002.
ADDRESSES:
Written
comments
should
be
sent
to
Diane
E.
McConkey,
Air
and
Radiation
Law
Office
(
2344A),
Office
of
General
Counsel,
U.
S.
Environmental
Protection
Agency,
1200
Pennsylvania
Avenue,
NW.,
Washington,
DC
20004.
A
copy
of
the
proposed
settlement
agreement
is
available
from
Phyllis
J.
Cochran,
(
202)
564
7606.
SUPPLEMENTARY
INFORMATION:
From
time
to
time
EPA
publishes
in
the
Federal
Register
notices
of
recent
postings
to
the
Applicability
Determination
Index
Database
System
(
ADI
Posting
Notices),
similar
to
the
two
notices
at
issue
in
these
petitions
for
review.
The
following
entities
filed
petitions
for
review
of
one
or
both
of
the
ADI
Posting
Notices
described
above:
Utility
Air
Regulatory
Group
(
UARG),
January
11,
2002
(
November
15,
2001
notice)
and
March
11,
2002
(
January
10,
2002
notice);
Clean
Air
Implementation
Project
(
CAIP),
January
14,
2002
(
November
15,
2001
notice);
American
Chemistry
Council
(
ACC),
January
14,
2002
(
November
15,
2001
notice);
National
Environmental
Development
Association's
Clean
Air
Regulatory
Project
(
NEDA/
CARP),
January
14,
2002
(
November
15,
2001
and
January
10,
2002
notices).
UARG,
CAIP,
ACC,
NEDA/
CARP,
and
EPA
have
now
reached
initial
agreement
on
a
settlement
of
the
consolidated
cases
which
could
lead
to
the
voluntary
dismissal
of
the
petitions
for
review.
The
settlement
requires
the
EPA
Administrator
to
include
specific
language
in
the
first
ADI
Posting
Notice
signed
after
the
settlement
agreement
is
final
and
effective.
For
a
period
of
thirty
(
30)
days
following
the
date
of
publication
of
this
notice,
EPA
will
receive
written
comments
relating
to
the
proposed
settlement
agreement.
EPA
or
the
Department
of
Justice
may
withdraw
or
withhold
consent
to
the
proposed
settlement
agreement
if
the
comments
disclose
facts
or
considerations
that
indicate
that
such
consent
is
inappropriate,
improper,
inadequate,
or
inconsistent
with
the
requirements
of
the
Act.
Unless
EPA
or
the
Department
of
Justice
determines,
based
on
any
comment
which
may
be
submitted,
that
consent
to
the
settlement
agreement
should
be
withdrawn,
the
terms
of
the
agreement
will
be
affirmed.
Dated:
November
4,
2002.
Lisa
K.
Friedman,
Associate
General
Counsel,
Air
and
Radiation
Law
Office.
[
FR
Doc.
02
28843
Filed
11
12
02;
8:
45
am]
BILLING
CODE
6560
50
P
ENVIRONMENTAL
PROTECTION
AGENCY
[
OPP
2002
0265;
FRL
7280
8]
FIFRA
Scientific
Advisory
Panel;
Notice
of
Cancellation
of
Public
Meetings
AGENCY:
Environmental
Protection
Agency
(
EPA).
ACTION:
Notice.
SUMMARY:
In
the
Federal
Register
of
October
10,
2002
(
67
FR
63084)
(
FRL
7276
4),
EPA
announced
a
November
21,
2002,
pre
meeting
teleconference
and
a
December
3
5,
2002,
face
to
face
meeting
of
the
Federal
Insecticide,
Fungicide,
and
Rodenticide
Act
Scientific
Advisory
Panel
(
FIFRA
SAP)
to
consider
and
review
studies
on
water
disinfection
and
softening
as
related
to
the
Food
Quality
Protection
Act
(
FQPA)
drinking
water
exposure
assessments.
The
meetings
have
been
cancelled
because
of
logistical
problems.
A
new
set
of
meetings
will
be
announced
in
the
Federal
Register.
FOR
FURTHER
INFORMATION
CONTACT:
Paul
Lewis,
Designated
Federal
Official
(
DFO),
Office
of
Science
Coordination
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15:
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68864
Federal
Register
/
Vol.
67,
No.
219
/
Wednesday,
November
13,
2002
/
Notices
and
Policy
(
7201M),
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460
0001;
telephone
number:
(
202)
564
8450;
fax
number:
(
202)
564
8382;
email
address:
lewis.
paul@
epa.
gov.
SUPPLEMENTARY
INFORMATION:
I.
Does
this
Action
Apply
to
Me?
This
action
is
directed
to
the
public
in
general.
This
action
may
be
of
interest
to
persons
who
are
or
may
be
required
to
conduct
testing
of
chemical
substances
under
the
Federal
Food,
Drug,
and
Cosmetic
Act
(
FFDCA),
FIFRA,
and
FQPA.
Since
other
entities
may
also
be
interested,
the
Agency
has
not
attempted
to
describe
all
the
specific
entities
that
may
be
affected
by
this
action.
If
you
have
any
questions
regarding
the
applicability
of
this
action
to
a
particular
entity,
consult
the
DFO
listed
under
FOR
FURTHER
INFORMATION
CONTACT.
II.
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
0265.
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.
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.
List
of
Subjects
Environmental
protection,
Pesticides
and
pests.
Dated:
November
5,
2002.
Joseph
J.
Merenda,
Jr.,
Director,
Office
of
Science
Coordination
and
Policy.
[
FR
Doc.
02
28841
Filed
11
12
02;
8:
45
am]
BILLING
CODE
6560
50
S
ENVIRONMENTAL
PROTECTION
AGENCY
[
OPP
2002
0279;
FRL
7277
2]
Pesticide
Products;
Registration
Applications
AGENCY:
Environmental
Protection
Agency
(
EPA).
ACTION:
Notice.
SUMMARY:
This
notice
announces
receipt
of
applications
to
register
pesticide
products
containing
new
active
ingredients
not
included
in
any
previously
registered
products
pursuant
to
the
provisions
of
section
3(
c)(
4)
of
the
Federal
Insecticide,
Fungicide,
and
Rodenticide
Act
(
FIFRA),
as
amended.
DATES:
Written
comments,
identified
by
the
docket
ID
number
OPP
2002
0279,
must
be
received
on
or
before
December
13,
2002.
ADDRESSES:
Comments
may
be
submitted
electronically,
by
mail,
or
through
hand
delivery/
courier.
Follow
the
detailed
instructions
as
provided
in
Unit
I.
of
the
SUPPLEMENTARY
INFORMATION.
FOR
FURTHER
INFORMATION
CONTACT:
Joanne
I.
Miller,
Registration
Division
(
7505C),
Office
of
Pesticide
Programs,
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460
0001;
telephone
number:
(
703)
305
6224;
e
mail
address:
miller.
joanne@
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
a
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
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.
To
determine
whether
you
or
your
business
may
be
affected
by
this
action,
you
should
carefully
examine
the
applicability
provisions
in
unit
II
of
this
notice.
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
0279.
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.
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.
Certain
types
of
information
will
not
be
placed
in
the
EPA
Dockets.
Information
claimed
as
CBI
and
other
information
whose
disclosure
is
restricted
by
statute,
which
is
not
included
in
the
official
public
docket,
will
not
be
available
for
public
viewing
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15:
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12,
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| epa | 2024-06-07T20:31:43.974142 | regulations | {
"license": "Public Domain",
"url": "https://downloads.regulations.gov/EPA-HQ-OPP-2002-0265-0002/content.txt"
} |
EPA-HQ-OPP-2002-0266-0002 | Notice | "2002-10-11T04:00:00" | Methamidiphos; Organophosphate Pesticide; Availability of the Interim Risk Managment Decision
Document | 63423
Federal
Register
/
Vol.
67,
No.
198
/
Friday,
October
11,
2002
/
Notices
original
signature,
and
one
electronic
copy
via
e
mail
(acceptable
file
format:
Adobe
Acrobat,
WordPerfect,
Word,
or
Rich
Text
files
(in
IBM–
PC/
Windows
95/
98
format).
Those
providing
written
comments
and
who
attend
the
meeting
are
also
asked
to
bring
25
copies
of
their
comments
for
public
distribution.
Meeting
Access—
Individuals
requiring
special
accommodation
at
this
meeting,
including
wheelchair
access
to
the
conference
room,
should
contact
Dr.
Shallal
at
least
five
business
days
prior
to
the
meeting
so
that
appropriate
arrangements
can
be
made.
General
Information—
Additional
information
concerning
the
EPA
Science
Advisory
Board,
its
structure,
function,
and
composition,
may
be
found
on
the
SAB
Web
site
http://
www.
epa.
gov/
sab
and
in
the
EPA
Science
Advisory
Board
FY2001
Annual
Staff
Report
which
is
available
from
the
SAB
Publications
Staff
at
(202)
564–
4533
or
via
fax
at
(202)
501–
0256.
Dated:
October
8,
2002.
A.
Robert
Flaak,
Acting
Deputy
Director,
EPA
Science
Advisory
Board
Staff
Office.
[FR
Doc.
02–
26170
Filed
10–
10–
02;
8:
45
am]
BILLING
CODE
6560–
50–
P
ENVIRONMENTAL
PROTECTION
AGENCY
[OPP–
2002–
0266;
FRL–
7276–
1]
Methamidophos;
Organophosphate
Pesticide;
Availability
of
Interim
Risk
Management
Decision
Document
AGENCY:
Environmental
Protection
Agency
(EPA).
ACTION:
Notice.
SUMMARY:
This
notice
announces
the
availability
of
the
Interim
Reregistration
Eligibility
Decision
(IRED)
document
and
technical
support
documents
for
the
organophosphate
(OP)
pesticide,
methamidophos.
These
documents
have
been
developed
using
a
public
participation
process
designed
by
EPA
and
the
U.
S.
Department
of
Agriculture
to
involve
the
public
in
the
reassessment
of
pesticide
tolerances
under
the
Food
Quality
Protection
Act
and
the
reregistration
of
individual
OPs
under
the
Federal
Insecticide,
Fungicide,
and
Rodenticide
Act.
FOR
FURTHER
INFORMATION
CONTACT:
Mark
Hartman,
Special
Review
and
Reregistration
Division
(7508C),
Office
of
Pesticide
Programs,
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460–
0001;
telephone
number:
(703)
308–
0734;
fax
number:
(703)
308–
8041;
email
address:
hartman.
mark@
epa.
gov.
SUPPLEMENTARY
INFORMATION:
I.
General
Information
A.
Does
this
Action
Apply
to
Me?
This
action
is
directed
to
the
public
in
general,
but
will
interest
a
widerange
of
stakeholders,
including
environmental,
human
health,
and
agricultural
advocates;
the
chemical
industry;
pesticide
users;
and
members
of
the
public
interested
in
the
use
of
pesticides
on
food.
The
Agency
has
not
attempted
to
describe
all
the
persons
or
entities
who
may
be
interested
in
or
affected
by
this
action.
If
you
have
questions
in
this
regard,
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–
0266.
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.
Please
note
that
technical
supporting
documents
for
methamidophos
can
be
found
under
legacy
docket
number
OPP–
34166
and
may
not
be
available
in
EPA
Dockets.
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/.
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
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.
Please
note
that
technical
supporting
documents
for
methamidophos
can
be
found
under
legacy
docket
number
OPP–
34166
and
may
not
be
available
in
EPA
Dockets.
II.
Background
A.
What
Action
is
the
Agency
Taking?
For
the
OP
pesticide
methamidophos,
the
Agency
is
announcing
the
availability
of
the
IRED
document
and
supporting
technical
documents.
EPA
has
assessed
the
risks
associated
with
the
use
of
methamidophos
and
reached
an
interim
reregistration
eligibility
decision
for
methamidophos.
The
methamidophos
IRED
and
supporting
technical
documents
were
developed
using
the
OP
public
participation
process,
which
was
designed
to
increase
transparency
and
maximize
stakeholder
involvement
and
to
provide
numerous
opportunities
for
public
comment.
You
can
read
more
about
the
OP
public
participation
process
at
http://
www.
epa.
gov/
pesticides/
op/
process.
htm.
Below
is
a
brief
summary
of
EPA's
interim
decision,
which
is
fully
described
in
the
methamidophos
IRED
document.
EPA
has
determined
that
methamidophos
is
eligible
for
reregistration,
pending
a
full
reassessment
of
the
cumulative
risk
from
all
OP
pesticides,
and
provided
that
all
the
conditions
identified
in
the
IRED
document
are
satisfied,
including
implementation
of
risk
mitigation
measures.
Without
implementation
of
the
risk
mitigation
measures,
the
Agency
has
determined
that
methamidophos
products
may
pose
unreasonable
adverse
effects
on
human
health
and
the
environment.
Therefore,
EPA
expects
that
registrant
will
implement
the
risk
mitigation
measures
as
soon
as
possible.
The
IRED
document
describes,
in
detail,
what
is
necessary
for
implementing
the
risk
mitigation
measures,
such
as
submission
of
label
amendments
for
end
use
products
and
submission
of
any
required
data.
Mitigation
measures
for
methamidophos
include
a
phase
out
of
methamidophos
use
on
cotton
by
2007.
Should
a
registrant
fail
to
implement
any
of
the
risk
mitigation
identified
in
the
IRED
document,
the
Agency
may
take
regulatory
action
to
address
risk
concerns
from
the
use
of
methamidophos.
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Federal
Register
/
Vol.
67,
No.
198
/
Friday,
October
11,
2002
/
Notices
B.
What
is
the
Agency's
Authority
for
Taking
this
Action?
The
legal
authority
for
this
action
falls
under
FIFRA,
as
amended
in
1988
and
1996.
Section
4(
g)(
2)(
A)
of
FIFRA
directs
that,
after
submission
of
all
data
concerning
a
pesticide
active
ingredient,
``
the
Administrator
shall
determine
whether
pesticides
containing
such
active
ingredient
are
eligible
for
reregistration,
''
before
calling
in
product
specific
data
on
individual
enduse
products,
and
either
reregistering
products
or
taking
``
other
appropriate
regulatory
action.
''
List
of
Subjects
Environmental
protection,
Chemicals,
Pesticides
and
pests.
Dated:
September
24,
2002.
Lois
Ann
Rossi,
Director,
Special
Review
and
Reregistration
Division,
Registration
Division,
Office
of
Pesticide
Programs.
[FR
Doc.
02–
25861
Filed
10–
10–
02;
8:
45
am]
BILLING
CODE
6560–
50–
S
ENVIRONMENTAL
PROTECTION
AGENCY
[OPP–
2002–
0261;
FRL–
7275–
9]
Notice
of
Receipt
of
Requests
for
Amendments
to
Delete
Uses
in
Certain
Pesticide
Registrations
AGENCY:
Environmental
Protection
Agency
(EPA).
ACTION:
Notice.
SUMMARY:
In
accordance
with
section
6(
f)(
1)
of
the
Federal
Insecticide,
Fungicide,
and
Rodenticide
Act
(FIFRA),
as
amended,
EPA
is
issuing
a
notice
of
receipt
of
request
for
amendments
by
registrants
to
delete
uses
in
certain
pesticide
registrations.
Section
6(
f)(
1)
of
FIFRA
provides
that
a
registrant
of
a
pesticide
product
may
at
any
time
request
that
any
of
its
pesticide
registrations
be
amended
to
delete
one
or
more
uses.
FIFRA
further
provides
that,
before
acting
on
the
request,
EPA
must
publish
a
notice
of
receipt
of
any
request
on
the
Federal
Register.
DATES:
The
deletions
are
effective
on
April
9,
2003,
or
on
November
12,
2002,
for
products
with
registration
numbers
007401–
00267,
062719–
00081,
and
062719–
84,
unless
the
Agency
receives
a
withdrawal
request
on
or
before
April
9,
2003,
or
on
before
November
12,
2002,
for
products
with
registration
numbers
007401–
00267,
062719–
00081,
and
062719–
00084.
Users
of
these
products
who
desire
continued
use
on
crops
or
sites
being
deleted
should
contact
the
applicable
registrant
on
or
before
dates
given
above.
ADDRESSES:
Withdrawal
requests
may
be
submitted
by
mail,
electronically,
or
in
person.
Please
follow
the
detailed
instructions
for
each
method
as
provided
in
Unit
I.
of
the
SUPPLEMENTARY
INFORMATION.
To
ensure
proper
receipt
by
EPA,
it
is
imperative
that
you
identify
docket
ID
number
OPP–
2002–
0261
in
the
subject
line
on
the
first
page
of
your
response.
FOR
FURTHER
INFORMATION
CONTACT:
By
mail:
James
A.
Hollins,
Office
of
Pesticide
Programs
(7502C),
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460–
0001;
telephone
number:
(703)
305–
5761;
e
mail
address:
hollins.
james@
epa.
gov.
SUPPLEMENTARY
INFORMATION:
I.
General
Information
A.
Does
this
Action
Apply
to
Me?
This
action
is
directed
to
the
public
in
general.
Although
this
action
may
be
of
particular
interest
to
persons
who
produce
or
use
pesticides,
the
Agency
has
not
attempted
to
describe
all
the
specific
entities
that
may
be
affected
by
this
action.
If
you
have
any
questions
regarding
the
information
in
this
notice,
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
ID
number
OPP–
2002–
0261.
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/.
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.
What
Action
is
the
Agency
Taking?
This
notice
announces
receipt
by
the
Agency
of
applications
from
registrants
to
delete
uses
in
certain
pesticide
registrations.
These
registrations
are
listed
in
the
following
Table
1
by
registration
number,
product
name/
active
ingredient,
and
specific
uses
deleted:
TABLE
1.—
REGISTRATIONS
WITH
REQUESTS
FOR
AMENDMENTS
TO
DELETE
USES
IN
CERTAIN
PESTICIDE
REGISTRATIONS
Registration
Number
Product
Name
Active
Ingredient
Delete
from
Label
006959–
00092
Cesso
Fire
Ant
Killer
Piperonyl
butoxide;
tetramethrin;
permethrin,
mixed
cis,
trans
Indoor
uses
and
use
on
outside
surfaces
of
buildings
007401–
00267
Hi
Yield
5%
Malathion
Dust
Malathion
dust
Use
on
corn
062719–
00081
Lontrel
F
Technical
Clopyralid
Residential
turf
062719–
00084
Lontrel
35A
Clopyralid
Residential
turf
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| epa | 2024-06-07T20:31:43.997046 | regulations | {
"license": "Public Domain",
"url": "https://downloads.regulations.gov/EPA-HQ-OPP-2002-0266-0002/content.txt"
} |
EPA-HQ-OPP-2002-0267-0001 | Notice | "2002-10-24T04:00:00" | Thymol and Eucalyptus Oil; Receipt of Application for Emergencvy Exemption, Solicitation of Public
Comments. | 65351
Federal
Register
/
Vol.
67,
No.
206
/
Thursday,
October
24,
2002
/
Notices
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.
Did
EPA
Conditionally
Approve
the
Application?
A
conditional
registration
may
be
granted
under
section
3(
c)(
7)(
C)
of
FIFRA
for
a
new
active
ingredient
where
certain
data
are
lacking,
on
condition
that
such
data
are
received
by
the
end
of
the
conditional
registration
period
and
do
not
meet
or
exceed
the
risk
criteria
set
forth
in
40
CFR
154.7;
that
use
of
the
pesticide
during
the
conditional
registration
period
will
not
cause
unreasonable
adverse
effects;
and
that
use
of
the
pesticide
is
in
the
public
interest.
The
Agency
has
considered
the
available
data
on
the
risks
associated
with
the
proposed
use
of
Macleaya
extract,
and
information
on
social,
economic,
and
environmental
benefits
to
be
derived
from
such
use.
Specifically,
the
Agency
has
considered
the
nature
and
its
pattern
of
use,
application
methods
and
rates,
and
level
and
extent
of
potential
exposure.
Based
on
these
reviews,
the
Agency
was
able
to
make
basic
health
and
safety
determinations
which
show
that
use
of
Macleaya
extract
during
the
period
of
conditional
registration
will
not
cause
any
unreasonable
adverse
effect
on
the
environment,
and
that
use
of
the
pesticide
is,
in
the
public
interest.
Consistent
with
section
3(
c)(
7)(
C)
of
FIFRA,
the
Agency
has
determined
that
these
conditional
registrations
are
in
the
public
interest.
Use
of
the
pesticides
are
of
significance
to
the
user
community,
and
appropriate
labeling,
use
directions,
and
other
measures
have
been
taken
to
ensure
that
use
of
the
pesticides
will
not
result
in
unreasonable
adverse
effects
to
man
and
the
environment.
III.
Conditionally
Approved
Registrations
EPA
issued
a
notice,
published
in
the
Federal
Register
of
January
19,
2000
(65
FR
2948)
(FRL–
6485–
1),
which
announced
that
Camas
Technologies,
Inc.,
P.
O.
Box
1357,
Broomfield,
CO
80038–
1357,
had
submitted
an
application
to
conditionally
register
the
pesticide
product,
Qwel
Fungicide
(EPA
File
Symbol
69876–
R),
containing
Macleaya
extract
at
1.5%
an
active
ingredient
not
included
in
any
previously
registered
product.
The
application
was
conditionally
approved
on
September
19,
2002,
as
Qwel
(CTI
13
19B)
Liquid
Concentrate,
an
end
use
product;
for
foliar
application
to
ornamental
crops
in
enclosed
greenhouses
for
the
control
of
powdery
mildew
and
Alternaria
and
Septoria
leaf
spots
(EPA
Registration
Number
69876–
1).
List
of
Subjects
Environmental
protection,
Pesticides
and
pest.
Dated:
October
6,
2002.
Debra
Edwards,
Acting
Director,
Registration
Division,
Office
of
Pesticide
Programs.
[FR
Doc.
02–
27128
Filed
10–
23–
02;
8:
45
am]
BILLING
CODE
6560–
50–
S
ENVIRONMENTAL
PROTECTION
AGENCY
[OPP–
2002–
0267;
FRL–
7276–
2]
Thymol
and
Eucalyptus
Oil;
Receipt
of
Application
for
Emergency
Exemption,
Solicitation
of
Public
Comment
AGENCY:
Environmental
Protection
Agency
(EPA).
ACTION:
Notice.
SUMMARY:
EPA
has
received
a
specific
exemption
request
from
the
Maine
Department
of
Agriculture,
Food,
and
Rural
Resources
to
use
the
pesticide
thymol
and
eucalyptus
oil
(CAS
numbers
89–
83–
8
and
8000–
48–
4,
respectively)
to
treat
up
to
13,000
hives
of
honey
and
beeswax
to
control
Varroa
mite.
The
Applicant
proposes
the
use
of
the
new
chemical,
eucalyptus
oil
which
has
not
been
registered
by
EPA
and
the
Applicant
proposes
a
first
food
use
of
thymol.
EPA
is
soliciting
public
comment
before
making
the
decision
whether
or
not
to
grant
the
exemption.
DATES:
Comments,
identified
by
docket
ID
number
OPP–
2002–
0267,
must
be
received
on
or
before
November
8,
2002.
ADDRESSES:
Comments
may
be
submitted
electronically,
by
mail,
or
through
hand
delivery/
courier.
Follow
the
detailed
instructions
as
provided
in
Unit
I.
of
the
SUPPLEMENTARY
INFORMATION.
FOR
FURTHER
INFORMATION
CONTACT:
Barbara
Madden,
Registration
Division
(7505C),
Office
of
Pesticide
Programs,
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460–
0001;
telephone
number:
(703)
305–
6463;
fax
number:
(703)
308–
5433;
e
mail
address:
Sec
18
Mailbox@
epamail.
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
a
federal
or
state
government
agency
involved
in
administration
of
environmental
quality
programs.
Potentially
affected
entities
may
include,
but
are
not
limited
to:
Federal
or
state
government
entity,
(NAICS
9241),
e.
g.,
Department
of
Agriculture,
Environment,
etc.
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.
To
determine
whether
you
or
your
business
may
be
affected
by
this
action,
you
should
carefully
examine
the
applicability
provisions
in
Unit
II.
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–
0267.
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/.
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,
''
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Notices
then
key
in
the
appropriate
docket
ID
number.
Certain
types
of
information
will
not
be
placed
in
the
EPA
Dockets.
Information
claimed
as
CBI
and
other
information
whose
disclosure
is
restricted
by
statute,
which
is
not
included
in
the
official
public
docket,
will
not
be
available
for
public
viewing
in
EPA's
electronic
public
docket.
EPA's
policy
is
that
copyrighted
material
will
not
be
placed
in
EPA's
electronic
public
docket
but
will
be
available
only
in
printed,
paper
form
in
the
official
public
docket.
To
the
extent
feasible,
publicly
available
docket
materials
will
be
made
available
in
EPA's
electronic
public
docket.
When
a
document
is
selected
from
the
index
list
in
EPA
Dockets,
the
system
will
identify
whether
the
document
is
available
for
viewing
in
EPA's
electronic
public
docket.
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.
EPA
intends
to
work
towards
providing
electronic
access
to
all
of
the
publicly
available
docket
materials
through
EPA's
electronic
public
docket.
For
public
commenters,
it
is
important
to
note
that
EPA's
policy
is
that
public
comments,
whether
submitted
electronically
or
in
paper,
will
be
made
available
for
public
viewing
in
EPA's
electronic
public
docket
as
EPA
receives
them
and
without
change,
unless
the
comment
contains
copyrighted
material,
CBI,
or
other
information
whose
disclosure
is
restricted
by
statute.
When
EPA
identifies
a
comment
containing
copyrighted
material,
EPA
will
provide
a
reference
to
that
material
in
the
version
of
the
comment
that
is
placed
in
EPA's
electronic
public
docket.
The
entire
printed
comment,
including
the
copyrighted
material,
will
be
available
in
the
public
docket.
Public
comments
submitted
on
computer
disks
that
are
mailed
or
delivered
to
the
docket
will
be
transferred
to
EPA's
electronic
public
docket.
Public
comments
that
are
mailed
or
delivered
to
the
Docket
will
be
scanned
and
placed
in
EPA's
electronic
public
docket.
Where
practical,
physical
objects
will
be
photographed,
and
the
photograph
will
be
placed
in
EPA's
electronic
public
docket
along
with
a
brief
description
written
by
the
docket
staff.
C.
How
and
To
Whom
Do
I
Submit
Comments?
You
may
submit
comments
electronically,
by
mail,
or
through
hand
delivery/
courier.
To
ensure
proper
receipt
by
EPA,
identify
the
appropriate
docket
ID
number
in
the
subject
line
on
the
first
page
of
your
comment.
Please
ensure
that
your
comments
are
submitted
within
the
specified
comment
period.
Comments
received
after
the
close
of
the
comment
period
will
be
marked
``
late.
''
EPA
is
not
required
to
consider
these
late
comments.
If
you
wish
to
submit
CBI
or
information
that
is
otherwise
protected
by
statute,
please
follow
the
instructions
in
Unit
I.
D.
Do
not
use
EPA
Dockets
or
e
mail
to
submit
CBI
or
information
protected
by
statute.
1.
Electronically.
If
you
submit
an
electronic
comment
as
prescribed
in
this
unit,
EPA
recommends
that
you
include
your
name,
mailing
address,
and
an
email
address
or
other
contact
information
in
the
body
of
your
comment.
Also
include
this
contact
information
on
the
outside
of
any
disk
or
CD
ROM
you
submit,
and
in
any
cover
letter
accompanying
the
disk
or
CD
ROM.
This
ensures
that
you
can
be
identified
as
the
submitter
of
the
comment
and
allows
EPA
to
contact
you
in
case
EPA
cannot
read
your
comment
due
to
technical
difficulties
or
needs
further
information
on
the
substance
of
your
comment.
EPA's
policy
is
that
EPA
will
not
edit
your
comment,
and
any
identifying
or
contact
information
provided
in
the
body
of
a
comment
will
be
included
as
part
of
the
comment
that
is
placed
in
the
official
public
docket,
and
made
available
in
EPA's
electronic
public
docket.
If
EPA
cannot
read
your
comment
due
to
technical
difficulties
and
cannot
contact
you
for
clarification,
EPA
may
not
be
able
to
consider
your
comment.
i.
EPA
Dockets.
Your
use
of
EPA's
electronic
public
docket
to
submit
comments
to
EPA
electronically
is
EPA's
preferred
method
for
receiving
comments.
Go
directly
to
EPA
Dockets
at
http://
www.
epa.
gov/
edocket,
and
follow
the
online
instructions
for
submitting
comments.
Once
in
the
system,
select
``
search,
''
and
then
key
in
docket
ID
number
OPP–
2002–
0267.
The
system
is
an
``
anonymous
access''
system,
which
means
EPA
will
not
know
your
identity,
e
mail
address,
or
other
contact
information
unless
you
provide
it
in
the
body
of
your
comment.
ii.
E
mail.
Comments
may
be
sent
by
e
mail
to
opp
docket@
epa.
gov,
Attention:
Docket
ID
Number
OPP–
2002–
0267.
In
contrast
to
EPA's
electronic
public
docket,
EPA's
e
mail
system
is
not
an
``
anonymous
access''
system.
If
you
send
an
e
mail
comment
directly
to
the
docket
without
going
through
EPA's
electronic
public
docket,
EPA's
e
mail
system
automatically
captures
your
e
mail
address.
E
mail
addresses
that
are
automatically
captured
by
EPA's
e
mail
system
are
included
as
part
of
the
comment
that
is
placed
in
the
official
public
docket,
and
made
available
in
EPA's
electronic
public
docket.
iii.
Disk
or
CD
ROM.
You
may
submit
comments
on
a
disk
or
CD
ROM
that
you
mail
to
the
mailing
address
identified
in
Unit
I.
C.
2.
These
electronic
submissions
will
be
accepted
in
WordPerfect
or
ASCII
file
format.
Avoid
the
use
of
special
characters
and
any
form
of
encryption.
2.
By
mail.
Send
your
comments
to:
Public
Information
and
Records
Integrity
Branch
(PIRIB),
Office
of
Pesticide
Programs
(OPP),
Environmental
Protection
Agency
(7502C),
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460–
0001,
Attention:
Docket
ID
Number
OPP–
2002–
0267.
3.
By
hand
delivery
or
courier.
Deliver
your
comments
to:
Public
Information
and
Records
Integrity
Branch
(PIRIB),
Office
of
Pesticide
Programs
(OPP),
Environmental
Protection
Agency,
Rm.
119,
Crystal
Mall
#2,
1921
Jefferson
Davis
Hwy.,
Arlington,
VA,
Attention:
Docket
ID
Number
OPP–
2002–
0267.
Such
deliveries
are
only
accepted
during
the
docket's
normal
hours
of
operation
as
identified
in
Unit
I.
B.
1.
D.
How
Should
I
Submit
CBI
To
the
Agency?
Do
not
submit
information
that
you
consider
to
be
CBI
electronically
through
EPA's
electronic
public
docket
or
by
e
mail.
You
may
claim
information
that
you
submit
to
EPA
as
CBI
by
marking
any
part
or
all
of
that
information
as
CBI
(if
you
submit
CBI
on
disk
or
CD
ROM,
mark
the
outside
of
the
disk
or
CD
ROM
as
CBI
and
then
identify
electronically
within
the
disk
or
CD
ROM
the
specific
information
that
is
CBI).
Information
so
marked
will
not
be
disclosed
except
in
accordance
with
procedures
set
forth
in
40
CFR
part
2.
In
addition
to
one
complete
version
of
the
comment
that
includes
any
information
claimed
as
CBI,
a
copy
of
the
comment
that
does
not
contain
the
information
claimed
as
CBI
must
be
submitted
for
inclusion
in
the
public
docket
and
EPA's
electronic
public
docket.
If
you
submit
the
copy
that
does
not
contain
CBI
on
disk
or
CD
ROM,
mark
the
outside
of
the
disk
or
CD
ROM
clearly
that
it
does
not
contain
CBI.
Information
not
marked
as
CBI
will
be
included
in
the
public
docket
and
EPA's
electronic
public
docket
without
prior
notice.
If
you
have
any
questions
about
CBI
or
the
procedures
for
claiming
CBI,
please
consult
the
person
listed
under
FOR
FURTHER
INFORMATION
CONTACT.
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24,
2002
/
Notices
E.
What
Should
I
Consider
as
I
Prepare
My
Comments
for
EPA?
You
may
find
the
following
suggestions
helpful
for
preparing
your
comments:
1.
Explain
your
views
as
clearly
as
possible.
2.
Describe
any
assumptions
that
you
used.
3.
Provide
copies
of
any
technical
information
and/
or
data
you
used
that
support
your
views.
4.
If
you
estimate
potential
burden
or
costs,
explain
how
you
arrived
at
the
estimate
that
you
provide.
5.
Provide
specific
examples
to
illustrate
your
concerns.
6.
Offer
alternative
ways
to
improve
the
notice.
7.
Make
sure
to
submit
your
comments
by
the
deadline
in
this
document.
8.
To
ensure
proper
receipt
by
EPA,
be
sure
to
identify
the
docket
ID
number
assigned
to
this
action
in
the
subject
line
on
the
first
page
of
your
response.
You
may
also
provide
the
name,
date,
and
Federal
Register
citation.
II.
Background
A.
What
Action
is
the
Agency
Taking?
Under
section
18
of
the
Federal
Insecticide,
Fungicide,
and
Rodenticide
Act
(FIFRA)
(7
U.
S.
C.
136p),
at
the
discretion
of
the
Administrator,
a
federal
or
state
agency
may
be
exempted
from
any
provision
of
FIFRA
if
the
Administrator
determines
that
emergency
conditions
exist
which
require
the
exemption.
The
Maine
Department
of
Agriculture,
Food,
and
Rural
Resources
has
requested
the
Administrator
to
issue
a
specific
exemption
for
the
use
of
thymol
and
eucalyptus
oil
on
honey
and
beeswax
to
control
Varroa
mite.
Information
in
accordance
with
40
CFR
part
166
was
submitted
as
part
of
this
request.
As
part
of
this
request,
the
Applicant
asserts
that
Varroa
mites
were
first
detected
in
Maine
in
November
of
1987.
Since
1988,
beekeepers
have
treated
their
colonies
with
fluvalinate
to
control
Varroa.
Varroa
mite
resistance
to
fluvalinate
is
widespread
in
Maine.
In
1999,
a
section
18
emergency
exemption
was
granted
by
EPA
for
the
treatment
of
Varroa
and
the
small
hive
beetle.
During
the
fall
of
2001,
a
Florida
Maine
migratory
beekeeping
operation
was
determined
to
have
Varroa
with
resistance
to
coumaphos
and
fluvalinate.
Maine
produced
231,000
pounds
of
honey
in
2000
valued
at
$173,000
wholesale.
The
honey
bee
and
beekeeping
industry
is
essential
for
crop
pollination.
Maine
is
the
primary
producer
of
blueberries
in
the
world,
an
industry
that
contributes
$75
100
million
to
the
state's
annual
economy.
Honey
bees
also
pollinate
the
state's
apple
crop
and
other
fruits
and
vegetables
with
an
estimated
value
of
over
$30
million
per
year.
The
Applicant
proposes
to
treat
13,000
hives
in
late
summer
or
fall
at
least
5
months
prior
to
harvesting
the
honey.
A
maximum
of
26,000
tablets
weighing
11
grams
each
will
be
used.
This
notice
does
not
constitute
a
decision
by
EPA
on
the
application
itself.
The
regulations
governing
section
18
of
FIFRA
require
publication
of
a
notice
of
receipt
of
an
application
for
a
specific
exemption
proposing
use
of
a
new
chemical
(i.
e.,
an
active
ingredient)
which
has
not
been
registered
by
EPA,
as
well
as
a
first
food
use
of
a
chemical.
The
notice
provides
an
opportunity
for
public
comment
on
the
application.
The
Agency,
will
review
and
consider
all
comments
received
during
the
comment
period
in
determining
whether
to
issue
the
specific
exemption
requested
by
the
Maine
Department
of
Agriculture,
Food,
and
Rural
Resources.
List
of
Subjects
Environmental
protection,
Pesticides
and
pests.
Dated:
October
6,
2002.
Debra
Edwards,
Acting
Director,
Registration
Division,
Office
of
Pesticide
Programs.
[FR
Doc.
02–
27129
Filed
10–
23–
02;
8:
45
am]
BILLING
CODE
6560–
50–
S
ENVIRONMENTAL
PROTECTION
AGENCY
[FRL–
7398–
3]
Proposed
Prospective
Purchaser
Agreement
under
CERCLA
for
the
Midwest
Portland
Cement
Superfund
Site
AGENCY:
United
States
Environmental
Protection
Agency
(``
USEPA'').
ACTION:
Proposal
of
CERCLA
prospective
purchaser
agreement
for
the
Midwest
Portland
Cement
Superfund
Site.
SUMMARY:
USEPA
is
proposing
to
execute
a
Prospective
Purchaser
Agreement
(``
PPA'')
under
authority
of
the
Comprehensive
Environmental
Response,
Compensation,
and
Liability
Act
of
1980
(``
CERCLA''),
42
U.
S.
C.
9601
et
seq.,
as
amended,
and
under
the
inherent
authority
of
the
Attorney
General
of
the
United
States
to
compromise
and
settle
claims
of
the
United
States,
for
the
transfer
of
title
to
property
at
the
Midwest
Portland
Cement
Superfund
Site,
located
in
East
Fultonham,
Ohio,
to
a
purchaser
who
will
obtain
title
to
the
Site
through
the
judicial
sale
process.
The
PPA
is
intended
to
resolve
the
liability
under
CERCLA
of
the
purchaser
for
costs
incurred
by
USEPA
in
conducting
response
actions
at
the
Site.
In
return
for
a
covenant
not
to
sue
and
contribution
protection
from
USEPA,
subject
to
standard
reservations
of
rights,
the
purchaser
will
pay
$350,000
in
reimbursement
of
USEPA's
response
costs.
The
Site
was
operated
by
the
Midwest
Portland
Cement
Company
(``
MPC'')
as
a
cement
manufacturing
and
limestone
mining
facility
until
ceasing
operations
in
March,
1993.
USEPA's
response
action
at
the
Site
was
completed
on
January
20,
1998.
The
Site
is
not
on
the
National
Priorities
List.
No
further
response
activities
by
USEPA
are
anticipated
at
the
Site
at
this
time.
The
MPC
estate
is
being
liquidated
under
Chapter
7
of
the
Bankruptcy
Code
in
the
United
States
Bankruptcy
Court
for
the
Western
District
of
Pennsylvania
(Case
No.
97–
23098–
JLC).
MPC's
real
estate
was
the
subject
of
a
judicial
sale
that
took
place
on
June
18,
2002.
DATES:
Comments
on
this
proposed
PPA
must
be
received
by
November
25,
2002.
ADDRESSES:
A
copy
of
the
proposed
PPA
is
available
for
review
at
USEPA,
Region
5,
77
West
Jackson
Boulevard,
Chicago,
Illinois
60604.
Please
contact
Kevin
C.
Chow
at
(312)
353–
6181,
prior
to
visiting
the
Region
5
office.
Comments
on
the
proposed
PPA
should
be
addressed
to
Kevin
C.
Chow,
Office
of
Regional
Counsel
(C–
14J),
USEPA,
Region
5,
77
West
Jackson
Boulevard,
Chicago,
Illinois
60604.
FOR
FURTHER
INFORMATION
CONTACT:
Kevin
C.
Chow,
Office
of
Regional
Counsel,
at
(312)
353–
6181.
SUPPLEMENTARY
INFORMATION:
In
accordance
with
CERCLA,
notice
is
hereby
given
of
a
proposed
Prospective
Purchaser
Agreement
concerning
the
Midwest
Portland
Cement
Superfund
Site,
located
at
6400
Maysville
Pike,
East
Fultonham,
Muskingum
County,
Ohio.
The
proposed
PPA
has
been
signed
and
approved
by
USEPA
and
the
Department
of
Justice,
subject
to
review
by
the
public
pursuant
to
this
Notice.
The
purchaser—
Belmont
Leasing,
Inc.
(``
Belmont
Leasing'')—
participated
in
the
judicial
sale
of
the
Site
and
successfully
bid
for
title
to
the
property.
Belmont
Leasing
will
be
required
to
execute
the
signature
page
for
the
PPA
at
the
closing
of
the
sale.
Under
the
proposed
PPA,
the
Settling
Respondent
will
pay
$350,000
in
reimbursement
of
USEPA's
response
costs,
and
will
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| epa | 2024-06-07T20:31:44.004598 | regulations | {
"license": "Public Domain",
"url": "https://downloads.regulations.gov/EPA-HQ-OPP-2002-0267-0001/content.txt"
} |
EPA-HQ-OPP-2002-0268-0001 | Notice | "2002-10-16T04:00:00" | Notice of Receipt of Requests to Voluntarily Cancel Certain Pesticide Registration | 63909
Federal
Register
/
Vol.
67,
No.
200
/
Wednesday,
October
16,
2002
/
Notices
September
30,
2002,
and
request
any
waivers
of
the
Commission's
regulations
that
may
be
necessary
to
permit
such
an
effective
date.
Comment
Date:
October
23,
2002.
11.
Southern
Company
Services,
Inc.
[Docket
No.
ER03–
8–
000]
Take
notice
on
October
2,
2002,
Southern
Company
Services,
Inc.
(SCS),
acting
on
behalf
of
Georgia
Power
Company
(Georgia
Power),
tendered
for
filing
the
Amendment
to
the
Interchange
Contract
Between
Georgia
Power
and
Crisp
County
Power
Commission
(Crisp
County)
dated
as
of
September
27,
2002
(the
Amendment).
The
Amendment
modifies
that
certain
Interchange
Contract
between
Georgia
Power
and
Crisp
County
dated
as
of
July
1,
1980.
The
amended
Interchange
Contract
has
been
designated
as
First
Revised
Rate
Schedule
FERC
No.
803.
The
Amendment
revises
Service
Schedule
B
and
Service
Schedule
C
of
the
Interchange
Contract.
SCS
has
requested
an
effective
date
of
October
3,
2002,
for
the
Amendment.
Comment
Date:
October
23,
2002.
12.
Westar
Energy,
Inc.
[Docket
No.
ER03–
9–
000]
Take
notice
that
on
October
2,
2002,
Westar
Energy,
Inc.
(Westar
Energy)
filed
a
Notification
of
Change
in
Status
and
Petition
for
Acceptance
of
Revised
Market
Rate
Schedules
to
reflect
(1)
Westar
Energy's
name
change
from
Western
Resources,
Inc.
and
(2)
cancellation
of
Westar
Energy's
proposed
merger
with
Public
Service
Company
of
New
Mexico,
all
as
more
fully
described
in
the
Application.
Comment
Date:
October
23,
2002.
13.
ONEOK
Energy
Marketing
and
Trading
Company,
L.
P.
[Docket
No.
ER03–
10–
000]
Take
notice
that
on
October
2,
2002,
ONEOK
Energy
Marketing
and
Trading
Company,
L.
P.
(OEMT)
tendered
for
filing
Electric
Tariff,
Original
Volume
No.
1,
which
will
supercede
ONEOK
Power
Marketing
Company's
(OPMC)
FERC
Electric
Tariff,
Original
Volume
No.
1.
This
filing
is
the
result
of
the
merger
by
and
between
OEMT
and
OPMC,
which
was
consummated
on
October
1,
2002.
OEMT
requests
an
effective
date
of
April
1,
2001.
A
copy
of
the
filing
was
served
upon
the
Oklahoma
Corporation
Commission.
Comment
Date:
October
23,
2002.
14.
Louisville
Gas
and
Electric
Company/
Kentucky
Utilities
Company
[Docket
No.
ER03–
11–
000]
Take
notice
that
on
October
3,
2002,
Louisville
Gas
and
Electric
Company
(LG&
E)/
Kentucky
Utilities
(KU)
(hereinafter
Companies)
tendered
for
filing
an
unexecuted
unilateral
Service
Sales
Agreement
between
Companies
and
Southern
Illinois
Power
Cooperative
under
the
Companies'
Rate
Schedule
MBSS.
Comment
Date:
October
24,
2002.
15.
MidAmerican
Energy
Company
[Docket
No.
ER03–
12–
000]
Take
notice
that
on
October
3,
2002,
MidAmerican
Energy
Company
(MidAmerican),
401
Douglas
Street,
P.
O.
Box
778,
Sioux
City
Iowa
51102,
filed
with
the
Federal
Energy
Regulatory
Commission
(Commission)
an
Electric
Transmission
Interconnection
Agreement
between
Iowa
Public
Service
Company
n/
k/
a
MidAmerican
Energy
Company,
dated
March
1,
1991,
which
incorporates
the
Fifth
Amendment
to
the
Agreement,
dated
June
28,
2002.
The
Agreement
is
pursuant
to
MidAmerican's
Open
Access
Transmission
Tariff.
MidAmerican
has
served
a
copy
of
the
filing
on
the
Iowa
Utilities
Board,
the
Illinois
Commerce
Commission
and
the
South
Dakota
Public
Utilities
Commission.
Comment
Date:
October
24,
2002.
16.
New
York
Independent
System
Operator,
Inc.
[Docket
No.
ER03–
13–
000]
Take
notice
that
on
October
3,
2002,
the
New
York
Independent
System
Operator,
Inc.
(NYISO)
filed
revisions
to
its
Market
Administration
and
Control
Area
Services
Tariff
(Services
Tariff)
to
implement
an
Unforced
Capacity
Deliverability
Rights
(UDR)
product
in
the
Installed
Capacity
market
in
New
York.
The
NYISO
has
served
a
copy
of
this
filing
to
all
parties
that
have
executed
Service
Agreements
under
the
NYISO's
Open
Access
Transmission
Tariff
or
Services
Tariff,
the
New
York
State
Public
Service
Commission
and
to
the
electric
utility
regulatory
agencies
in
New
Jersey
and
Pennsylvania.
Comment
Date:
October
24,
2002.
17.
Southwest
Power
Pool,
Inc.
[Docket
No.
ER03–
14–
000
Take
notice
that
on
October
3,
2002,
Southwest
Power
Pool,
Inc.
(SPP)
filed
changes
to
the
SPP
Open
Access
Transmission
Tariff
(SPP
Tariff)
intended
to
implement
certain
rate
changes
applicable
to
the
Southwestern
Power
Administration
pricing
zone.
SPP
seeks
an
effective
date
of
October
1,
2002
for
these
changes.
A
copy
of
this
filing
was
served
on
all
transmission
customers
under
the
SPP
Tariff
and
on
all
affected
state
commission.
Comment
Date:
October
24,
2002.
Standard
Paragraph
Any
person
desiring
to
intervene
or
to
protest
this
filing
should
file
with
the
Federal
Energy
Regulatory
Commission,
888
First
Street,
NE.,
Washington,
DC
20426,
in
accordance
with
rules
211
and
214
of
the
Commission's
rules
of
practice
and
procedure
(18
CFR
385.211
and
385.214).
Protests
will
be
considered
by
the
Commission
in
determining
the
appropriate
action
to
be
taken,
but
will
not
serve
to
make
protestants
parties
to
the
proceeding.
Any
person
wishing
to
become
a
party
must
file
a
motion
to
intervene.
All
such
motions
or
protests
should
be
filed
on
or
before
the
comment
date,
and,
to
the
extent
applicable,
must
be
served
on
the
applicant
and
on
any
other
person
designated
on
the
official
service
list.
This
filing
is
available
for
review
at
the
Commission
or
may
be
viewed
on
the
Commission's
Web
site
at
http://
www.
ferc.
gov
using
the
``
RIMS''
link,
select
``
Docket
#''
and
follow
the
instructions
(call
202–
208–
2222
for
assistance).
Protests
and
interventions
may
be
filed
electronically
via
the
Internet
in
lieu
of
paper;
see
18
CFR
385.2001(
a)(
1)(
iii)
and
the
instructions
on
the
Commission's
Web
site
under
the
``
e
Filing''
link.
Magalie
R.
Salas,
Secretary.
[FR
Doc.
02–
26259
Filed
10–
15–
02;
8:
45
am]
BILLING
CODE
6717–
01–
P
ENVIRONMENTAL
PROTECTION
AGENCY
[OPP–
2002–
0268;
FRL–
7276–
6]
Notice
of
Receipt
of
Requests
to
Voluntarily
Cancel
Certain
Pesticide
Registrations
AGENCY:
Environmental
Protection
Agency
(EPA).
ACTION:
Notice.
SUMMARY:
In
accordance
with
section
6(
f)(
1)
of
the
Federal
Insecticide,
Fungicide,
and
Rodenticide
Act
(FIFRA),
as
amended,
EPA
is
issuing
a
notice
of
receipt
of
request
by
registrants
to
voluntarily
cancel
certain
pesticide
registrations.
DATES:
Unless
a
request
is
withdrawn
by
April
14,
2003,
or
unless
indicated
otherwise,
orders
will
be
issued
canceling
all
of
these
registrations.
Comments
on
EPA
Registration
Numbers
000655–
00741,
000655–
00742,
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Federal
Register
/
Vol.
67,
No.
200
/
Wednesday,
October
16,
2002
/
Notices
001812–
00354,
001812–
00448,
009688–
00131,
and
034911–
00027
must
be
received
by
November
15,
2002.
FOR
FURTHER
INFORMATION
CONTACT:
James
A.
Hollins,
Information
Resources
Services
Division
(7502C),
Office
of
Pesticide
Programs,
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460–
0001;
telephone
number:
(703)
305–
5761;
e
mail
address:
hollins.
james@
epa.
gov.
SUPPLEMENTARY
INFORMATION:
I.
General
Information
A.
Does
this
Action
Apply
to
Me?
This
action
is
directed
to
the
public
in
general.
Although
this
action
may
be
of
particular
interest
to
persons
who
produce
or
use
pesticides,
the
Agency
has
not
attempted
to
describe
all
the
specific
entities
that
may
be
affected
by
this
action.
If
you
have
any
questions
regarding
the
information
in
this
notice,
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
ID
number
OPP–
2002–
0268.
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/.
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.
What
Action
is
the
Agency
Taking?
This
notice
announces
receipt
by
the
Agency
of
applications
from
registrants
to
cancel
33
pesticide
products
registered
under
section
3
or
24(
c)
of
FIFRA.
These
registrations
are
listed
in
sequence
by
registration
number
(or
company
number
and
24(
c)
number)
in
the
following
Table
1
of
this
unit:
TABLE
1.—
REGISTRATIONS
WITH
PENDING
REQUESTS
FOR
CANCELLATION
Registration
Number
Product
Name
Chemical
Name
000100
OR–
02–
0016
Cyclone
Concentrate/
Gramoxone
Max
1,1'
Dimethyl
4,4'
bipyridinium
dichloride
000100
WA–
02–
0018
Cyclone
Concentrate/
Gramoxone
Max
1,1'
Dimethyl
4,4'
bipyridinium
dichloride
000352
AZ–
01–
0001
Dupont
Staple
Herbicide
Sodium
2
chloro
6(
4,6
dimethoxypyrimidin
2
ylthio)
benzoate
000352
AZ–
01–
0002
Dupont
PE
350/
MON
B
In
B
Herbicide
Sodium
2
chloro
6(
4,6
dimethoxypyrimidin
2
ylthio)
benzoate
Isopropylamine
glyphosate
N
phosphonomethyl)
glycine)
000524–
00476
Harness
Plus
Herbicide
2'
Ethyl
6'
methyl
N(
ethoxymethyl)
2
chloroacetanilide
000655–
00741
Prentox
Methoxychlor
50W
Methoxychlor
(2,2
bis(
p
methoxyphenyl)
1,1,1
trichloroethane
000655–
00742
Prentox
2
Lb.
Methoxychlor
Spray
Methoxychlor
(2,2
bis(
p
methoxyphenyl)
1,1,1
trichloroethane
001812–
00351
Pro
Tex
Manganese
ethylenebis(
dithiocarbamate)
Triphenyltin
hydroxide
001812–
00354
Indoor
Roach
Bait
1
Octanesulfonamide,
N
ethyl1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8
heptadecafluoro001812
00448
Finitron
Brand
Sulfuramid
RB
MUP
1
Octanesulfonamide,
N
ethyl1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8
heptadecafluoro003008
00069
Bardec
Part
I
Arsenic
acid
003008–
00070
Bardec
Part
2
Cuprous
oxide
003008–
00071
Bardec
Part
3
Zinc
oxide
003125–
00102
Guthion
2l
Emulsifiable
Insecticide
O,
O
Dimethyl
S((
4
oxo
1,2,3
benzotriazin
3(
4H)
yl
methyl)
phosphorodithioate
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16,
2002
/
Notices
TABLE
1.—
REGISTRATIONS
WITH
PENDING
REQUESTS
FOR
CANCELLATION—
Continued
Registration
Number
Product
Name
Chemical
Name
004691–
00157
Commando
Insecticide
Cattle
Ear
Tag
O,
O,
O',
O'
Tetraethyl
S,
S'
methylene
bis(
phosphorodithioate)
008177–
00073
Enterprise
Clear
Wood
Preservative
3
Iodo
2
propynyl
butylcarbamate
009688–
00131
Chemsico
Roach
Control
System
CS
O,
O
Diethyl
O(
3,5,6
trichloro
2
pyridyl)
phosphorothioate
1
Octanesulfonamide,
N
ethyl1,1,2,2,3,3,4,4,5,5,6,6,7,7,8,8,8
heptadecafluoro010163
00166
Imidan
50–
WP
Agricultural
Insecticide
N(
Mercaptomethyl)
phthalimide
S(
O,
O
dimethyl
phosphorodithioate)
010163–
00170
Imidan
12.5–
WP
Home
Garden
Insecticide
N(
Mercaptomethyl)
phthalimide
S(
O,
O
dimethyl
phosphorodithioate)
010163–
00173
Imidan
1
E
Home
Garden
Insecticide
N(
Mercaptomethyl)
phthalimide
S(
O,
O
dimethyl
phosphorodithioate)
010163–
00227
Prolate
Technical
Livestock
Insecticide
N(
Mercaptomethyl)
phthalimide
S(
O,
O
dimethyl
phosphorodithioate)
034704–
00691
Clean
Crop
Sniper
2
E
Azinphos
Methyl
Insecticide
O,
O
Dimethyl
S((
4
oxo
1,2,3
benzotriazin
3(
4H)
yl
methyl)
phosphorodithioate
034704
OR–
88–
0014
Clean
Crop
Cheat
Stop
90
WDG
2
Chloro
4(
ethylamino)
6(
isopropylamino)
s
triazine
034704
WA–
88–
0019
Clean
Crop
Cheat
Stop
90
WDG
2
Chloro
4(
ethylamino)
6(
isopropylamino)
s
triazine
034911–
00027
Hi
Yield
Benomyl
Systemic
Fungicide
Methyl
1(
butylcarbamoyl)
2
benzimidazolecarbamate
045385–
00087
Cenol
Dairy
Cattle
Spray
Dipropyl
isocinchomeronate
N
Octyl
bicycloheptene
dicarboximide
(Butylcarbityl)(
6
propylpiperonyl)
ether
80%
and
related
compounds
20%
Pyrethrins
051036–
00073
Dibrom
8EC
1,2
Dibromo
2,2
dichloroethyl
dimethyl
phosphate
059639
GA–
99–
0001
Select
Herbicide
2
Cyclohexen
1
one,
2(
1(((
3
chloro
2
propenyl
oxy)
imino)
propyl)
5(
2
059639
WA–
89–
0026
Orthene
75
S
Soluble
Powder
O,
S
Dimethyl
acetylphosphoramidothioate
062190–
00005
Wolmanac
Concentrate
70%
Arsenic
pentoxide
Chromic
acid
Cupric
oxide
062190–
00011
CCA
Type
C
50%
Chromated
Copper
Arsenate
Arsenic
pentoxide
Chromic
acid
Cupric
oxide
066222–
00016
Cotnion
Methyl
Azinphos
Methyl
2EC
O,
O
Dimethyl
S((
4
oxo
1,2,3
benzotriazin
3(
4H)
yl
methyl)
phosphorodithioate
070171–
00004
Ioblend
20
Nonylphenoxypolyethoxyethanol
iodine
complex
Unless
a
request
is
withdrawn
by
the
registrant
within
the
180
or
30–
day
comment
period,
orders
will
be
issued
canceling
all
of
these
registrations.
Users
of
these
pesticides
or
anyone
else
desiring
the
retention
of
a
registration
should
contact
the
applicable
registrant
directly
during
either
of
these
comment
periods.
Registrations
001812–
00448,
Finitron
Brand
Sulfluramid
RB
MUP,
001812–
00354,
Indoor
Roach
Bait,
and
009688–
00131,
Chemsico
Roach
Control
System
CS
are
registrations
for
which
the
terms
and
conditions
for
cancellation
and
disposition
of
existing
stocks
were
previously
agreed
to
between
EPA,
Griffin
L.
L.
C.
and
Chemsico
and
expressed
in
the
July
9,
2001
Registration/
Amendment
Notices
for
these
products.
Thus,
EPA
intends
to
grant
Griffin
and
Chemsico's
request
for
voluntary
cancellation
of
these
registrations
on
December
31,
2002.
Griffin
and
Chemsico
have
waived
the
180–
day
comment
period
provided
for
in
FIFRA
section
6(
f).
The
comment
period
will
be
the
required
30
days
from
notice
in
the
Federal
Register.
After
the
registrations
are
canceled,
EPA
will
permit
Griffin
to
sell
and
distribute
Registration
001812–
00448,
Finitron
Brand
Sulfluramid
RB
MUP
until
July
25,
2003,
and
Registration
001812–
00354,
Indoor
Roach
Bait
until
December
31,
2003,
and
permit
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16,
2002
/
Notices
Chemisco
to
sell
and
distribute
Registration
009688–
0013,
Chemsico
Roach
Control
System
CS
until
December
31,
2003.
Table
2
of
this
unit
includes
the
names
and
addresses
of
record
for
all
registrants
of
the
products
in
Table
1
of
this
unit,
in
ascending
sequence
by
EPA
company
number:
TABLE
2—
REGISTRANTS
REQUESTING
VOLUNTARY
CANCELLATION
EPA
Company
Number
Company
Name
and
Address
000100
Syngenta
Crop
Protection
Inc.
Box
18300
Greensboro,
NC
27419
000352
E.
I.
Du
Pont
De
Nemours
and
Company
Dupont
Crop
Protection
Stine
Haskell
Research
Center
S300
Box
30
Newark,
DE
19714
000524
Monsanto
Company
Agent
For:
Monsanto
Company
600
13th
Street,
NW.,
Suite
660
Washington,
DC
20005
000655
Prentiss
Inc.
C.
B.
2000
Floral
Park,
NY
11001
001812
Griffin
L.
L.
C.
Box
1847
Valdosta,
GA
31603
003008
Osmose
Inc.
980
Ellicott
Street
Buffalo,
NY
14209
003125
Bayer
Corp.
Agriculture
Division
8400
Hawthorn
Rd.,
Box
4913
Kansas
City,
MO
64120
004691
Boehringer
Ingelheim
Vetmedica,
Inc.
15th
&
Oak
Streets,
Way,
Box
338
Elwood,
KS
66024
008177
Valspar
Corp.
1101
Third
Street
South
Minneapolis,
MN
55415
009688
Chemsico,
Division
of
United
Industries
Corp.
Box
142642
St
Louis,
MO
63114
TABLE
2—
REGISTRANTS
REQUESTING
VOLUNTARY
CANCELLATION—
Continued
EPA
Company
Number
Company
Name
and
Address
010163
Gowan
Company
Box
5569
Yuma,
AZ
85366
034704
Jane
Cogswell
Agent
For:
Platte
Chemical
Co.
Inc.
Box
667
Greeley,
CO
80632
034911
Brazos
Associates,
Inc.
Agent
For:
Hi
Yield
Chemical
Co.
2001
Diamond
Ridge
Drive
Carrollton,
TX
75010
045385
CTX
Cenol,
Inc.
Box
472
Twinsburg,
OH
44087
051036
Micro
Flo
Co.
LLC
Box
772099
Memphis,
TN
38117
059639
Valent
U.
S.
A.
Corp.
1333
N.
California
Blvd,
Suite
600
Walnut
Creek,
CA
94596
062190
Arch
Wood
Protection,
Inc.
1955
Lake
Park
Drive,
Suite
250
Smyrna,
GA
30080
066222
Makhteshim
Agan
of
North
America
Inc.
551
Fifth
Avenue
Suite
1100
New
York,
NY
10176
070171
Unicore
Technologies
Inc.
Box
3877
Turlock,
CA
95381
III.
Loss
of
Active
Ingredients
Unless
the
request
for
cancellation
is
withdrawn,
the
pesticide
active
ingredient
listed
in
Table
3
below
will
no
longer
appear
in
any
registered
products.
Those
who
are
concerned
about
the
potential
loss
of
this
active
ingredient
for
pesticidal
use
are
encouraged
to
work
directly
with
the
registrant
to
explore
the
possibility
of
the
registrant
withdrawing
the
request
for
cancellation.
The
active
ingredient
is
listed
in
the
following
Table
3,
with
EPA
company
number
and
chemical
name.
TABLE
3—
ACTIVE
INGREDIENT
DISAPPEARING
AS
A
RESULT
OF
REGISTRANT'S
REQUEST
TO
CANCEL
EPA
Company
Number
Company
Name
and
Address
034911
Benomyl
IV.
What
is
the
Agency's
Authority
for
Taking
this
Action?
Section
6(
f)(
1)
of
FIFRA
provides
that
a
registrant
of
a
pesticide
product
may
at
any
time
request
that
any
of
its
pesticide
registrations
be
canceled.
FIFRA
further
provides
that,
before
acting
on
the
request,
EPA
must
publish
a
notice
of
receipt
of
any
such
request
in
the
Federal
Register.
Thereafter,
the
Administrator
may
approve
such
a
request.
V.
Procedures
for
Withdrawal
of
Request
Registrants
who
choose
to
withdraw
a
request
for
cancellation
must
submit
such
withdrawal
in
writing
to
the
person
listed
under
FOR
FURTHER
INFORMATION
CONTACT,
postmarked
before
either
of
the
comment
periods
listed
under
DATES.
This
written
withdrawal
of
the
request
for
cancellation
will
apply
only
to
the
applicable
FIFRA
section
6(
f)(
1)
request
listed
in
this
notice.
If
the
product(
s)
have
been
subject
to
a
previous
cancellation
action,
the
effective
date
of
cancellation
and
all
other
provisions
of
any
earlier
cancellation
action
are
controlling.
The
withdrawal
request
must
also
include
a
commitment
to
pay
any
reregistration
fees
due,
and
to
fulfill
any
applicable
unsatisfied
data
requirements.
VI.
Provisions
for
Disposition
of
Existing
Stocks
The
effective
date
of
cancellation
will
be
the
date
of
the
cancellation
order.
The
orders
effecting
these
requested
cancellations
will
generally
permit
a
registrant
to
sell
or
distribute
existing
stocks
for
1–
year
after
the
date
the
cancellation
request
was
received.
This
policy
is
in
accordance
with
the
Agency's
statement
of
policy
as
prescribed
in
the
Federal
Register
of
June
26,
1991
(56
FR
29362)
(FRL–
3846–
4).
Exceptions
to
this
general
rule
will
be
made
if
a
product
poses
a
risk
concern,
or
is
in
noncompliance
with
reregistration
requirements,
or
is
subject
to
a
Data
Call
In.
In
all
cases,
productspecific
disposition
dates
will
be
given
in
the
cancellation
orders.
Existing
stocks
are
those
stocks
of
registered
pesticide
products
which
are
currently
in
the
United
States
and
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/
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16,
2002
/
Notices
which
have
been
packaged,
labeled,
and
released
for
shipment
prior
to
the
effective
date
of
the
cancellation
action.
Unless
the
provisions
of
an
earlier
order
apply,
existing
stocks
already
in
the
hands
of
dealers
or
users
can
be
distributed,
sold,
or
used
legally
until
they
are
exhausted,
provided
that
such
further
sale
and
use
comply
with
the
EPA
approved
label
and
labeling
of
the
affected
product.
Exception
to
these
general
rules
will
be
made
in
specific
cases
when
more
stringent
restrictions
on
sale,
distribution,
or
use
of
the
products
or
their
ingredients
have
already
been
imposed,
as
in
a
Special
Review
action,
or
where
the
Agency
has
identified
significant
potential
risk
concerns
associated
with
a
particular
chemical.
List
of
Subjects
Environmental
protection,
Pesticides
and
pests.
Dated:
September
30,
2002.
Lind
Vlier
Moos,
Acting
Director,
Information
Resources
Services
Division,
Office
of
Pesticide
Programs.
[FR
Doc.
02–
26177
Filed
10–
15–
02;
8:
45
am]
BILLING
CODE
6560–
50–
S
ENVIRONMENTAL
PROTECTION
AGENCY
[OPPT–
2002–
0056;
FRL–
7275–
8]
1,1,2
Trichloroethane
Tier
I
Program
Review
Testing;
Notice
of
Availability
and
Solicitation
of
Comment
AGENCY:
Environmental
Protection
Agency
(EPA).
ACTION:
Notice.
SUMMARY:
Under
section
4
of
the
Toxic
Substances
Control
Act
(TSCA),
EPA
issued
a
testing
consent
order
that
incorporated
an
enforceable
consent
agreement
(ECA)
relating
to
1,1,2
trichloroethane
(TCE).
The
companies
subject
to
this
ECA
agreed
to
conduct
toxicity
testing,
develop
a
computational
dosimetry
model
for
route
to
route
extrapolations,
and
develop
pharmacokinetics
and
mechanistic
testing
data
that
are
intended
to
satisfy
the
toxicological
data
needs
for
TCE
identified
in
a
TSCA
section
4
proposed
test
rule
for
a
number
of
hazardous
air
pollutant
chemicals.
This
notice
announces
that
EPA
is
starting
the
Program
Review
component
of
the
TCE
ECA
alternative
testing
program,
and
solicits
comment
on
data
received
under
the
Tier
I
Program
Review
testing
segment
of
the
TCE
ECA.
Comments
are
expected
to
inform
EPA's
decision
on
whether
or
not
additional
data
and/
or
model
development
are
needed
before
Tier
II
testing
and
computational
dosimetry
modeling
for
route
to
route
extrapolations
proceed
for
the
Tier
II
endpoints
listed
in
the
TCE
ECA.
DATES:
Comments,
identified
by
docket
ID
number
OPPT–
2002–
0056,
must
be
received
on
or
before
November
15,
2002.
ADDRESSES:
Comments
may
be
submitted
electronically,
by
mail,
or
through
hand
delivery/
courier.
Follow
the
detailed
instructions
as
provided
in
Unit
I.
of
the
SUPPLEMENTARY
INFORMATION.
FOR
FURTHER
INFORMATION
CONTACT:
For
general
information
contact:
Barbara
Cunningham,
Acting
Director,
Environmental
Assistance
Division
(7408M),
Office
of
Pollution
Prevention
and
Toxics,
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460–
0001;
telephone
number:
(202)
554–
1404;
e
mail
address:
TSCA
Hotline@
epa.
gov.
For
technical
information
about
EPA's
Program
Review
contact:
Richard
Leukroth
or
John
Schaeffer,
Chemical
Control
Division
(7405M),
Office
of
Pollution
Prevention
and
Toxics,
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460–
0001;
telephone
number:
(202)
564–
8157;
e
mail
address:
ccd.
citb@
epa.
gov.
SUPPLEMENTARY
INFORMATION:
I.
General
Information
A.
Does
this
Action
Apply
to
Me?
This
action
is
directed
to
the
public
in
general,
and
may
be
of
particular
interest
to
those
persons
who
are
or
may
be
required
to
conduct
testing
of
chemical
substances
under
TSCA.
Since
other
entities
may
also
be
interested,
the
Agency
has
not
attempted
to
describe
all
the
specific
entities
that
may
be
affected
by
this
action.
If
you
have
any
questions
regarding
the
applicability
of
this
action
to
a
particular
entity,
consult
the
technical
person
listed
under
FOR
FURTHER
INFORMATION
CONTACT.
B.
How
Can
I
Get
Copies
of
this
Document
or
Other
Related
Documents?
1.
Docket.
EPA
has
established
an
official
public
docket
for
this
action
under
docket
identification
(ID)
number
OPPT–
2002–
0056.
OPPT–
2002–
0056
is
the
continuation
docket
for
the
TCE
ECA
which
originated
under
OPPTS
Docket
Number
42198.
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
EPA
Docket
Center,
Rm.
B102–
Reading
Room,
EPA
West,
1301
Constitution
Avenue,
NW.,
Washington,
DC.
The
EPA
Docket
Center
is
open
from
8:
30
a.
m.
to
4:
30
p.
m.,
Monday
through
Friday,
excluding
legal
holidays.
The
EPA
Docket
Center
Reading
Room
telephone
number
is
(202)
566–
1744
and
the
telephone
number
for
the
OPPT
Docket,
which
is
located
in
the
EPA
Docket
Center,
is
(202)
566–
0280.
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/.
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.
Certain
types
of
information
will
not
be
placed
in
the
EPA
Dockets.
Information
claimed
as
CBI
and
other
information
whose
disclosure
is
restricted
by
statute,
which
is
not
included
in
the
official
public
docket,
will
not
be
available
for
public
viewing
in
EPA's
electronic
public
docket.
EPA's
policy
is
that
copyrighted
material
will
not
be
placed
in
EPA's
electronic
public
docket
but
will
be
available
only
in
printed,
paper
form
in
the
official
public
docket.
To
the
extent
feasible,
publicly
available
docket
materials
will
be
made
available
in
EPA's
electronic
public
docket.
When
a
document
is
selected
from
the
index
list
in
EPA
Dockets,
the
system
will
identify
whether
the
document
is
available
for
viewing
in
EPA's
electronic
public
docket.
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.
EPA
intends
to
work
towards
providing
electronic
access
to
all
of
the
publicly
available
docket
materials
through
EPA's
electronic
public
docket.
VerDate
0ct<
02>
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20:
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15,
2002
Jkt
200001
PO
00000
Frm
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Fmt
4703
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4703
E:\
FR\
FM\
16OCN1.
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16OCN1
| epa | 2024-06-07T20:31:44.014107 | regulations | {
"license": "Public Domain",
"url": "https://downloads.regulations.gov/EPA-HQ-OPP-2002-0268-0001/content.txt"
} |
EPA-HQ-OPP-2002-0269-0001 | Notice | "2002-12-11T05:00:00" | Ethoprop; Availability of Interim Reregistration Eligibility Decision Document | [
Federal
Register:
December
11,
2002
(
Volume
67,
Number
238)]
[
Notices]
[
Page
76176
76177]
From
the
Federal
Register
Online
via
GPO
Access
[
wais.
access.
gpo.
gov]
[
DOCID:
fr11de02
35]
ENVIRONMENTAL
PROTECTION
AGENCY
[
OPP
2002
0269;
FRL
7189
6]
Ethoprop;
Availability
of
Interim
Reregistration
Eligibility
Decision
Document
AGENCY:
Environmental
Protection
Agency
(
EPA).
ACTION:
Notice.
SUMMARY:
This
notice
announces
availability
of
the
Interim
Reregistration
Eligibility
Decision
(
IRED)
document
for
the
pesticide
active
ingredient
ethoprop.
The
IRED
represents
EPA's
formal
regulatory
assessment
of
the
health
and
environmental
data
base
of
the
subject
chemical
and
presents
the
Agency's
interim
determination
regarding
which
pesticidal
uses
are
eligible
for
reregistration.
FOR
FURTHER
INFORMATION
CONTACT:
Anthony
Britten,
Special
Review
and
Reregistration
Division
(
7508C),
Office
of
Pesticide
Programs,
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460
0001;
telephone
number:
(
703)
308
8179;
e
mail
address:
britten.
anthony@
epa.
gov.
SUPPLEMENTARY
INFORMATION:
I.
General
Information
A.
Does
this
Action
Apply
to
Me?
This
action
is
directed
to
the
public
in
general.
This
action
may,
however,
be
of
interest
to
persons
who
are
or
may
be
required
to
conduct
testing
of
chemical
substances
under
the
Federal
Insecticide,
Fungicide,
and
Rodenticide
Act
(
FIFRA)
or
the
Federal
Food,
Drug,
and
Cosmetic
Act
(
FFDCA);
environmental,
human
health,
and
agricultural
advocates;
pesticide
users;
and
members
of
the
public
interested
in
the
use
of
pesticides.
Since
other
entities
may
also
be
interested,
the
Agency
has
not
attempted
to
describe
all
the
specific
entities
that
may
be
affected
by
this
action.
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
0269.
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/.
To
access
IRED
documents
and
IRED
fact
sheets
electronically,
go
directly
to
the
REDs
table
on
the
EPA
Office
of
Pesticide
Programs
Web
site,
at
http://
www.
epa.
gov/
pesticides/
rere
gistration/
status.
htm
.
An
electronic
version
of
the
latest
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.
Certain
types
of
information
will
not
be
placed
in
the
EPA
Dockets.
Information
claimed
as
CBI
and
other
information
whose
disclosure
is
restricted
by
statute,
which
is
not
included
in
the
official
public
docket,
will
not
be
available
for
public
viewing
in
EPA's
electronic
public
docket.
EPA's
policy
is
that
copyrighted
material
will
not
be
placed
in
EPA's
electronic
public
docket
but
will
be
available
only
in
printed,
paper
form
in
the
official
public
docket.
To
the
extent
feasible,
publicly
available
docket
materials
will
be
made
available
in
EPA's
electronic
public
docket.
When
a
document
is
selected
from
the
index
list
in
EPA
Dockets,
the
system
will
identify
whether
the
document
is
available
for
viewing
in
EPA's
electronic
public
docket.
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.
EPA
intends
to
work
towards
providing
electronic
access
to
all
of
the
publicly
available
docket
materials
through
EPA's
electronic
public
docket.
II.
Background
A.
What
Action
is
the
Agency
Taking?
EPA
has
assessed
the
risks
posed
by
the
use
of
the
active
ingredient
ethoprop,
and
issued
an
IRED
for
this
organophosphate
(
OP)
pesticide.
EPA
issues
an
IRED
for
a
pesticide
that
is
undergoing
reregistration,
requires
a
reregistration
eligibility
decision,
and
also
needs
a
cumulative
assessment
under
FQPA.
The
IRED,
issued
after
EPA
completes
the
individual
pesticide's
aggregate
risk
assessment,
may
include
taking
risk
reduction
measures;
for
example,
reducing
risks
to
workers
or
eliminating
uses
that
the
registrant
no
longer
wishes
to
maintain,
to
gain
the
benefits
of
these
changes
before
the
final
RED
can
be
issued
following
the
Agency's
consideration
of
cumulative
risks.
Through
cumulative
risk
assessment,
EPA
will
consider
whether
the
risks
posed
by
a
group
of
pesticides
that
act
the
same
way
in
the
body
meet
the
current
safety
standard
of
``
reasonable
certainty
of
no
harm''
as
defined
by
the
FQPA.
Provided
that
risk
mitigation
measures
stipulated
in
the
IRED
document
are
adopted,
EPA
has
made
the
determination
that
ethoprop
fits
into
its
own
``
risk
cup''
that
is,
its
individual
and
aggregate
risks
are
within
acceptable
levels.
Thus,
ethoprop
products,
except
for
the
liquid
formulation,
are
eligible
for
reregistration,
pending
consideration
of
the
cumulative
risk
for
all
OPs.
The
Agency
will
make
a
reregistration
eligibility
decision
for
the
liquid
formulation
of
ethoprop
at
a
later
time,
provided
certain
conditions
are
fulfilled.
All
registrants
of
pesticide
products
containing
the
active
ingredient
listed
in
this
document
have
been
sent
the
IRED
document,
and
must
respond
to
labeling
requirements
and
product
specific
data
requirements
(
if
applicable)
within
8
months
of
its
receipt.
Products
also
containing
other
pesticide
active
ingredients
will
not
be
reregistered
until
those
other
active
ingredients
are
[[
Page
76177]]
determined
to
be
eligible
for
reregistration.
The
reregistration
program
is
being
conducted
under
Congressionally
mandated
time
frames,
and
EPA
recognizes
both
the
need
to
make
timely
reregistration
decisions
and
to
involve
the
public.
EPA
worked
extensively
with
affected
parties
to
reach
the
decisions
presented
in
the
IRED
document.
Numerous
opportunities
for
public
comment
were
offered
as
the
IRED
was
being
developed.
The
ethoprop
IRED
document,
therefore,
is
issued
in
final,
without
a
formal
public
comment
period.
B.
What
is
the
Agency's
Authority
for
Taking
this
Action?
The
legal
authority
for
this
IRED
falls
under
FIFRA,
as
amended
in
1988
and
1996.
Section
4(
g)(
2)(
A)
of
FIFRA
directs
that,
after
submission
of
all
data
concerning
a
pesticide
active
ingredient,
``
the
Administrator
shall
determine
whether
pesticides
containing
such
active
ingredient
are
eligible
for
reregistration,''
before
calling
in
product
specific
data
on
individual
end
use
products,
and
either
reregistering
products
or
taking
``
other
appropriate
regulatory
action.''
List
of
Subjects
Environmental
protection,
Chemicals,
Pesticides
and
pests.
Dated:
November
22,
2002.
Lois
Rossi,
Director,
Special
Review
and
Reregistration
Division,
Office
of
Pesticide
Programs.
[
FR
Doc.
02
31163
Filed
12
10
02;
8:
45
am]
BILLING
CODE
6560
50
S
| epa | 2024-06-07T20:31:44.022480 | regulations | {
"license": "Public Domain",
"url": "https://downloads.regulations.gov/EPA-HQ-OPP-2002-0269-0001/content.txt"
} |
EPA-HQ-OPP-2002-0270-0001 | Notice | "2002-10-09T04:00:00" | Pesticide Product; Registration Applications. | 62965
Federal
Register
/
Vol.
67,
No.
196
/
Wednesday,
October
9,
2002
/
Notices
or
charges
under
the
Interchange
Agreement
as
previously
approved
and
on
file
with
this
Commission.
Comment
Date:
October
18,
2002.
Standard
Paragraph
Any
person
desiring
to
intervene
or
to
protest
this
filing
should
file
with
the
Federal
Energy
Regulatory
Commission,
888
First
Street,
NE.,
Washington,
DC
20426,
in
accordance
with
rules
211
and
214
of
the
Commission's
rules
of
practice
and
procedure
(18
CFR
385.211
and
385.214).
Protests
will
be
considered
by
the
Commission
in
determining
the
appropriate
action
to
be
taken,
but
will
not
serve
to
make
protestants
parties
to
the
proceeding.
Any
person
wishing
to
become
a
party
must
file
a
motion
to
intervene.
All
such
motions
or
protests
should
be
filed
on
or
before
the
comment
date,
and,
to
the
extent
applicable,
must
be
served
on
the
applicant
and
on
any
other
person
designated
on
the
official
service
list.
This
filing
is
available
for
review
at
the
Commission
or
may
be
viewed
on
the
Commission's
Web
site
at
http://
www.
ferc.
gov
using
the
``
RIMS''
link,
select
``
Docket
#''
and
follow
the
instructions
(call
202–
208–
2222
for
assistance).
Protests
and
interventions
may
be
filed
electronically
via
the
Internet
in
lieu
of
paper;
see
18
CFR
385.2001(
a)(
1)(
iii)
and
the
instructions
on
the
Commission's
web
site
under
the
``
e
Filing''
link.
Linwood
A.
Watson,
Jr.,
Deputy
Secretary.
[FR
Doc.
02–
25646
Filed
10–
8–
02;
8:
45
am]
BILLING
CODE
6717–
01–
P
DEPARTMENT
OF
ENERGY
Federal
Energy
Regulatory
Commission
Notice
of
Meeting,
Notice
of
Vote,
Explanation
of
Action
Closing
Meeting
and
List
of
Persons
To
Attend
October
2,
2002.
The
following
notice
of
meeting
is
published
pursuant
to
Section
3(
a)
of
the
Government
in
the
Sunshine
Act
(Pub.
L.
No.
94–
409),
5
U.
S.
C.
552b:
AGENCY
HOLDING
MEETING:
Federal
Energy
Regulatory
Commission.
DATE
AND
TIME:
October
9,
2002
(30
Minutes
Following
Regular
Commission
Meeting).
PLACE:
Hearing
Room
5,
888
First
Street,
NE.,
Washington,
DC
20426.
STATUS:
Closed.
MATTERS
TO
BE
CONSIDERED:
Non
Public,
Investigations
and
Inquiries
and
Enforcement
Related
Matters.
CONTACT
PERSON
FOR
MORE
INFORMATION:
Magalie
R.
Salas,
Secretary,
Telephone
(202)
502–
8400.
Chairman
Wood
and
Commissioners
Massey,
Breathitt
and
Brownell
voted
to
hold
a
closed
meeting
on
October
9,
2002.
The
certification
of
the
General
Counsel
explaining
the
action
closing
the
meeting
is
available
for
public
inspection
in
the
Commission's
Public
Reference
Room
at
888
First
Street,
NE.,
Washington,
DC
20426.
The
Chairman
and
the
Commissioners,
their
assistants,
the
Commission's
Secretary
and
her
assistant,
the
General
Counsel
and
members
of
her
staff,
and
a
stenographer
are
expected
to
attend
the
meeting.
Other
staff
members
from
the
Commission's
program
offices
who
will
advise
the
Commissioners
in
the
matters
discussed
will
also
be
present.
Magalie
R.
Salas,
Secretary.
[FR
Doc.
02–
25735
Filed
10–
4–
02;
8:
45
am]
BILLING
CODE
6717–
01–
P
ENVIRONMENTAL
PROTECTION
AGENCY
[FRL–
7392–
8]
Gulf
of
Mexico
Program
Citizens
Advisory
Committee
Meeting
AGENCY:
Environmental
Protection
Agency
(
EPA).
ACTION:
Notice
of
meeting.
SUMMARY:
Under
the
Federal
Advisory
Committee
Act
(Pub.
L.
92–
463),
EPA
gives
notice
of
a
meeting
of
the
Gulf
of
Mexico
Program
(GMP)
Citizens
Advisory
Committee
(CAC).
DATES:
The
meeting
will
be
held
on
Wednesday,
November
6,
2002,
from
1
p.
m.
to
5
p.
m.,
and
on
Thursday,
November
7,
2002,
from
8:
30
a.
m.
to
12
p.
m.
ADDRESSES:
The
meeting
will
be
held
at
the
Bay
Tower
Hotel
and
Conference
Center,
711
Casino
Magic
Drive,
Bay
St.
Louis,
MS
39520
(1–
800–
5–
MAGIC–
5)
FOR
FURTHER
INFORMATION
CONTACT:
Gloria
D.
Car,
Designated
Federal
Officer,
Gulf
of
Mexico
Program
Office,
Mail
Code
EPA/
GMPO,
Stennis
Space
Center,
MS
39529–
6000
at
(228)
688–
2421.
SUPPLEMENTARY
INFORMATION:
Proposed
agenda
is
attached.
The
meeting
is
open
to
the
public.
Dated:
September
30,
2002.
Gloria
D.
Car,
Designated
Federal
Officer.
Gulf
of
Mexico
Program—
Citizens
Advisory
Committee
Meeting—
Bay
Towers
Hotel
and
Conference
Center,
Bay
St.
Louis,
Mississippi,
November
6–
7,
2002
Draft
Agenda
Wednesday,
November
6
11:
45–
1:
00
CAC
Members
Networking
Luncheon
(at
hotel)
1:
00–
1:
20
p.
m.
Opening
Remarks/
Introductions
(Jim
Kachtick,
Chair),
Review
and
approval
of
November
7–
8,
2001
and
June
11–
13,
2002,
Meeting
Summaries,
Jim
Kachtick,
Chair
1:
20–
1:
45
Chair
Report,
Jim
Kachtick,
Chair
Follow
up
on
CAC
Action
Items
1:
45–
2:
15
GMP
Director's
Report,
Gloria
Car,
GMPO
Associate
Director
2:
15–
2:
30
Break
2:
30–
3:
15
Presentation:
Dockwatch
Update
(Jellyfish),
Dr.
William
Graham,
Dauphin
Island
Sea
Lab
3:
15–
5:
00
Casino
Magic
Golf
Course
Gulf
Guardian
Award
Video
Golf
Course
Tour
(tentative)
Evening
Dinner
Sponsored
by
Hancock
County
Board
of
Supervisors—
location
to
be
announced
Thursday,
November
7
7:
30–
8:
30
Continental
Breakfast
8:
30–
9:
15
CAC
Projects
Report,
Jennyfer
Smith,
Battelle
Dockwatch
Project
Coastal
Bird
Trail
FFA
Environmental
Speech
Project
GMP
Presentation
for
CAC
Members
CAC
Web
Page
and
Status
of
Bulletin
Board
9:
15–
9:
45
Election
of
Officers
9:
45–
10:
30
Members
Roundtable
and
Participation
Reports
10:
30–
10:
45
Break
10:
45–
11:
30
Presentation
on
the
Gulf
Restoration
Network,
Cynthia
Sarthou,
Gulf
Restoration
Network
11:
15–
11:
30
Meeting
Calendar
for
2003
11:
30–
12:
00
Citizens
Advisory
Committee
Wrap
up
Discussion
and
Recommendations
12:
00
Adjourn
[FR
Doc.
02–
25683
Filed
10–
8–
02;
8:
45
am]
BILLING
CODE
6560–
50–
P
ENVIRONMENTAL
PROTECTION
AGENCY
[OPP–
2002–
0270;
FRL–
7276–
7]
Pesticide
Product;
Registration
Application
AGENCY:
Environmental
Protection
Agency
(EPA).
ACTION:
Notice.
SUMMARY:
This
notice
announces
receipt
of
an
application
to
register
a
pesticide
product
containing
a
new
active
ingredient
not
included
in
any
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19:
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Oct
08,
2002
Jkt
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PO
00000
Frm
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Fmt
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4703
E:\
FR\
FM\
09OCN1.
SGM
09OCN1
62966
Federal
Register
/
Vol.
67,
No.
196
/
Wednesday,
October
9,
2002
/
Notices
previously
registered
products
pursuant
to
the
provisions
of
section
3(
c)(
4)
of
the
Federal
Insecticide,
Fungicide,
and
Rodenticide
Act
(FIFRA),
as
amended.
DATES:
Written
comments,
identified
by
the
docket
ID
number
OPP–
2002–
0270,
must
be
received
on
or
before
November
8,
2002.
ADDRESSES:
Comments
may
be
submitted
electronically,
by
mail,
or
through
hand
delivery/
courier.
Follow
the
detailed
instructions
as
provided
in
Unit
I.
of
the
SUPPLEMENTARY
INFORMATION.
FOR
FURTHER
INFORMATION
CONTACT:
Alan
Reynolds,
Biopesticides
and
Pollution
Prevention
Division
(7511C),
Office
of
Pesticide
Programs,
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460–
0001;
telephone
number:
(703)
605–
0515;
e
mail
address:
reynolds.
alan@
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
a
pesticide
manufacturer.
Potentially
affected
entities
may
include,
but
are
not
limited
to:
Pesticide
manufacturers
(NAICS
32532)
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–
0270.
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/.
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.
Certain
types
of
information
will
not
be
placed
in
EPA's
Dockets.
Information
claimed
as
CBI
and
other
information
whose
disclosure
is
restricted
by
statute,
which
is
not
included
in
the
official
public
docket,
will
not
be
available
for
public
viewing
in
EPA's
electronic
public
docket.
EPA's
policy
is
that
copyrighted
material
will
not
be
placed
in
EPA's
electronic
public
docket
but
will
be
available
only
in
printed,
paper
form
in
the
official
public
docket.
To
the
extent
feasible,
publicly
available
docket
materials
will
be
made
available
in
EPA's
electronic
public
docket.
When
a
document
is
selected
from
the
index
list
in
EPA
Dockets,
the
system
will
identify
whether
the
document
is
available
for
viewing
in
EPA's
electronic
public
docket.
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.
EPA
intends
to
work
towards
providing
electronic
access
to
all
of
the
publicly
available
docket
materials
through
EPA's
electronic
public
docket.
For
public
commenters,
it
is
important
to
note
that
EPA's
policy
is
that
public
comments,
whether
submitted
electronically
or
in
paper,
will
be
made
available
for
public
viewing
in
EPA's
electronic
public
docket
as
EPA
receives
them
and
without
change,
unless
the
comment
contains
copyrighted
material,
CBI,
or
other
information
whose
disclosure
is
restricted
by
statute.
When
EPA
identifies
a
comment
containing
copyrighted
material,
EPA
will
provide
a
reference
to
that
material
in
the
version
of
the
comment
that
is
placed
in
EPA's
electronic
public
docket.
The
entire
printed
comment,
including
the
copyrighted
material,
will
be
available
in
the
public
docket.
Public
comments
submitted
on
computer
disks
that
are
mailed
or
delivered
to
the
docket
will
be
transferred
to
EPA's
electronic
public
docket.
Public
comments
that
are
mailed
or
delivered
to
the
Docket
will
be
scanned
and
placed
in
EPA's
electronic
public
docket.
Where
practical,
physical
objects
will
be
photographed,
and
the
photograph
will
be
placed
in
EPA's
electronic
public
docket
along
with
a
brief
description
written
by
the
docket
staff.
C.
How
and
To
Whom
Do
I
Submit
Comments?
You
may
submit
comments
electronically,
by
mail,
or
through
hand
delivery/
courier.
To
ensure
proper
receipt
by
EPA,
identify
the
appropriate
docket
ID
number
in
the
subject
line
on
the
first
page
of
your
comment.
Please
ensure
that
your
comments
are
submitted
within
the
specified
comment
period.
Comments
received
after
the
close
of
the
comment
period
will
be
marked
``
late.
''
EPA
is
not
required
to
consider
these
late
comments.
If
you
wish
to
submit
CBI
or
information
that
is
otherwise
protected
by
statute,
please
follow
the
instructions
in
Unit
I.
D.
Do
not
use
EPA
Dockets
or
e
mail
to
submit
CBI
or
information
protected
by
statute.
1.
Electronically.
If
you
submit
an
electronic
comment
as
prescribed
in
this
unit,
EPA
recommends
that
you
include
your
name,
mailing
address,
and
an
email
address
or
other
contact
information
in
the
body
of
your
comment.
Also
include
this
contact
information
on
the
outside
of
any
disk
or
CD
ROM
you
submit,
and
in
any
cover
letter
accompanying
the
disk
or
CD
ROM.
This
ensures
that
you
can
be
identified
as
the
submitter
of
the
comment
and
allows
EPA
to
contact
you
in
case
EPA
cannot
read
your
comment
due
to
technical
difficulties
or
needs
further
information
on
the
substance
of
your
comment.
EPA's
policy
is
that
EPA
will
not
edit
your
comment,
and
any
identifying
or
contact
information
provided
in
the
body
of
a
comment
will
be
included
as
part
of
the
comment
that
is
placed
in
the
official
public
docket,
and
made
available
in
EPA's
electronic
public
docket.
If
EPA
cannot
read
your
comment
due
to
technical
difficulties
and
cannot
contact
you
for
clarification,
EPA
may
not
be
able
to
consider
your
comment.
i.
EPA
Dockets.
Your
use
of
EPA's
electronic
public
docket
to
submit
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Federal
Register
/
Vol.
67,
No.
196
/
Wednesday,
October
9,
2002
/
Notices
comments
to
EPA
electronically
is
EPA's
preferred
method
for
receiving
comments.
Go
directly
to
EPA
Dockets
at
http://
www.
epa.
gov/
edocket,
and
follow
the
online
instructions
for
submitting
comments.
Once
in
the
system,
select
``
search,
''
and
then
key
in
docket
ID
number
OPP–
2002–
0270.
The
system
is
an
``
anonymous
access''
system,
which
means
EPA
will
not
know
your
identity,
e
mail
address,
or
other
contact
information
unless
you
provide
it
in
the
body
of
your
comment.
ii.
E
mail.
Comments
may
be
sent
by
e
mail
to
opp
docket@
epa.
gov,
Attention:
Docket
ID
Number
OPP–
2002–
0270.
In
contrast
to
EPA's
electronic
public
docket,
EPA's
e
mail
system
is
not
an
``
anonymous
access''
system.
If
you
send
an
e
mail
comment
directly
to
the
docket
without
going
through
EPA's
electronic
public
docket,
EPA's
e
mail
system
automatically
captures
your
e
mail
address.
E
mail
addresses
that
are
automatically
captured
by
EPA's
e
mail
system
are
included
as
part
of
the
comment
that
is
placed
in
the
official
public
docket,
and
made
available
in
EPA's
electronic
public
docket.
iii.
Disk
or
CD
ROM.
You
may
submit
comments
on
a
disk
or
CD
ROM
that
you
mail
to
the
mailing
address
identified
in
Unit
I.
C.
2.
These
electronic
submissions
will
be
accepted
in
WordPerfect
or
ASCII
file
format.
Avoid
the
use
of
special
characters
and
any
form
of
encryption.
2.
By
mail.
Send
your
comments
to:
Public
Information
and
Records
Integrity
Branch
(PIRIB),
Office
of
Pesticide
Programs
(OPP),
Environmental
Protection
Agency
(7502C),
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460–
0001,
Attention:
Docket
ID
Number
OPP–
2002–
0270.
3.
By
hand
delivery
or
courier.
Deliver
your
comments
to:
Public
Information
and
Records
Integrity
Branch
(PIRIB),
Office
of
Pesticide
Programs
(OPP),
Environmental
Protection
Agency,
Rm.
119,
Crystal
Mall
#2,
1921
Jefferson
Davis
Hwy.,
Arlington,
VA,
Attention:
Docket
ID
Number
OPP–
2002–
0270.
Such
deliveries
are
only
accepted
during
the
docket's
normal
hours
of
operation
as
identified
in
Unit
I.
B.
1.
D.
How
Should
I
Submit
CBI
To
the
Agency?
Do
not
submit
information
that
you
consider
to
be
CBI
electronically
through
EPA's
electronic
public
docket
or
by
e
mail.
You
may
claim
information
that
you
submit
to
EPA
as
CBI
by
marking
any
part
or
all
of
that
information
as
CBI
(if
you
submit
CBI
on
disk
or
CD
ROM,
mark
the
outside
of
the
disk
or
CD
ROM
as
CBI
and
then
identify
electronically
within
the
disk
or
CD
ROM
the
specific
information
that
is
CBI).
Information
so
marked
will
not
be
disclosed
except
in
accordance
with
procedures
set
forth
in
40
CFR
part
2.
In
addition
to
one
complete
version
of
the
comment
that
includes
any
information
claimed
as
CBI,
a
copy
of
the
comment
that
does
not
contain
the
information
claimed
as
CBI
must
be
submitted
for
inclusion
in
the
public
docket
and
EPA's
electronic
public
docket.
If
you
submit
the
copy
that
does
not
contain
CBI
on
disk
or
CD
ROM,
mark
the
outside
of
the
disk
or
CD
ROM
clearly
that
it
does
not
contain
CBI.
Information
not
marked
as
CBI
will
be
included
in
the
public
docket
and
EPA's
electronic
public
docket
without
prior
notice.
If
you
have
any
questions
about
CBI
or
the
procedures
for
claiming
CBI,
please
consult
the
person
listed
under
FOR
FURTHER
INFORMATION
CONTACT.
E.
What
Should
I
Consider
as
I
Prepare
My
Comments
for
EPA?
You
may
find
the
following
suggestions
helpful
for
preparing
your
comments:
1.
Explain
your
views
as
clearly
as
possible.
2.
Describe
any
assumptions
that
you
used.
3.
Provide
copies
of
any
technical
information
and/
or
data
you
used
that
support
your
views.
4.
If
you
estimate
potential
burden
or
costs,
explain
how
you
arrived
at
the
estimate
that
you
provide.
5.
Provide
specific
examples
to
illustrate
your
concerns.
6.
Offer
alternative
ways
to
improve
the
registration
activity.
7.
Make
sure
to
submit
your
comments
by
the
deadline
in
this
notice.
8.
To
ensure
proper
receipt
by
EPA,
be
sure
to
identify
the
docket
ID
number
assigned
to
this
action
in
the
subject
line
on
the
first
page
of
your
response.
You
may
also
provide
the
name,
date,
and
Federal
Register
citation.
II.
Registration
Application
EPA
received
an
application
as
follows
to
register
a
pesticide
product
containing
an
active
ingredient
not
included
in
any
previously
registered
products
pursuant
to
the
provision
of
section
3(
c)(
4)
of
FIFRA.
Notice
of
receipt
of
this
application
does
not
imply
a
decision
by
the
Agency
on
the
application.
Product
Containing
an
Active
Ingredient
Not
Included
in
any
Previously
Registered
Products
File
symbol:
74411–
R.
Applicant:
Insect
Biotechnology,
Inc.,
100
Capitola
Drive,
Suite
307,
Durham,
NC
27713.
Product
name:
Technical
Trypsin
Modulating
Oostatic
Factor
(TMOF).
Product
type:
Insecticide.
Active
ingredient:
Trypsin
Modulating
Oostatic
Factor
at
100%.
Proposed
classification/
Use:
Manufacturing
use
product
for
formulation
into
insecticidal
products
for
mosquito
control.
List
of
Subjects
Environmental
protection,
Pesticides
and
pest.
Dated:
September
30,
2002.
Janet
L.
Andersen,
Director,
Biopesticides
and
Pollution
Prevention
Division,
Office
of
Pesticide
Programs.
[FR
Doc.
02–
25684
Filed
10–
8–
02;
8:
45
am]
BILLING
CODE
6560–
50–
S
ENVIRONMENTAL
PROTECTION
AGENCY
[OPP–
2002–
0244;
FRL–
7198––
2]
Notice
of
Filing
a
Pesticide
Petition
to
Establish
a
Tolerance
for
a
Certain
Pesticide
Chemical
in
or
on
Food
AGENCY:
Environmental
Protection
Agency
(EPA).
ACTION:
Notice.
SUMMARY:
This
notice
announces
the
initial
filing
of
a
pesticide
petition
proposing
the
establishment
of
regulations
for
residues
of
a
certain
pesticide
chemical
in
or
on
various
food
commodities.
DATES:
Comments,
identified
by
docket
ID
number
OPP–
2002–
0244,
must
be
received
on
or
before
November
8,
2002.
ADDRESSES:
Comments
may
be
submitted
electronically,
by
mail,
or
through
hand
delivery/
courier.
Follow
the
detailed
instructions
as
provided
in
Unit
I.
of
the
SUPPLEMENTARY
INFORMATION.
To
ensure
proper
receipt
by
EPA,
it
is
imperative
that
you
identify
docket
ID
number
OPP–
2002–
0244
in
the
subject
line
on
the
first
page
of
your
response.
FOR
FURTHER
INFORMATION
CONTACT:
By
mail:
Leonard
Cole,
Biopesticide
and
Pollution
Prevention
Division,
Office
of
Pesticide
Programs,
(7511C)
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460;
telephone
number:
(703)
305–
5412;
e
mail
address:
cole.
leonard@
epa.
gov.
SUPPLEMENTARY
INFORMATION:
I.
General
Information
A.
Does
this
Action
Apply
to
Me?
You
may
be
affected
by
this
action
if
you
are
an
agricultural
producer,
food
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| epa | 2024-06-07T20:31:44.025948 | regulations | {
"license": "Public Domain",
"url": "https://downloads.regulations.gov/EPA-HQ-OPP-2002-0270-0001/content.txt"
} |
EPA-HQ-OPP-2002-0271-0001 | Notice | "2002-10-24T04:00:00" | Pesticide Product Registrations; Conditional Approval | 65350
Federal
Register
/
Vol.
67,
No.
206
/
Thursday,
October
24,
2002
/
Notices
D.
Greenspace/
Open
Space
(a
maximum
of
15
points
may
be
received
for
this
criterion)
E.
Community
Involvement
(a
maximum
of
20
points
may
be
received
for
this
criterion)
Revolving
Loan
Fund
Grants—
Final
Proposal
(By
Invitation
Only)
Budget
(a
maximum
of
15
points
may
be
received
for
this
criterion)
Ranking
Criteria
A.
Business
Plan
(a
maximum
of
20
points
may
be
received
for
this
criterion)
B.
Sustainable
Reuse
of
Brownfields/
Development
Potential
(a
maximum
of
15
points
may
be
received
for
this
criterion)
C.
Reduction
of
Threats
to
Human
Health
and
the
Environment
(a
maximum
of
20
points
may
be
received
for
this
criterion)
D.
Reuse
of
Existing
Infrastructure
(a
maximum
of
15
points
may
be
received
for
this
criterion)
E.
Greenspace/
Open
Space
(a
maximum
of
15
points
may
be
received
for
this
criterion)
F.
Community
Involvement
(a
maximum
of
20
points
may
be
received
for
this
criterion)
Cleanup
Grants—
Final
Proposal
(By
Invitation
Only)
Budget
(a
maximum
of
15
points
may
be
received
for
this
criterion)
Ranking
Criteria
A.
Sustainable
Reuse
of
Brownfields/
Development
Potential
(a
maximum
of
15
points
may
be
received
for
this
criterion)
B.
Reduction
of
Threats
to
Human
Health
and
the
Environment
(a
maximum
of
20
points
may
be
received
for
this
criterion)
C.
Reuse
of
Existing
Infrastructure
(a
maximum
of
15
points
may
be
received
for
this
criterion)
D.
Greenspace/
Open
Space
(a
maximum
of
15
points
may
be
received
for
this
criterion)
E.
Community
Involvement
(a
maximum
of
20
points
may
be
received
for
this
criterion)
EPA
decisions
may
take
into
account
other
statutory
and
policy
considerations,
such
as
urban
and
nonurban
distribution
and
other
geographic
factors;
compliance
with
the
statutory
petroleum
funding
allocation;
the
benefits
of
promoting
the
long
term
availability
of
funds
under
the
RLF
grants;
designation
as
a
federal
Empowerment
Zone,
Enterprise
Community,
or
Renewal
Community;
population;
and
whether
the
applicant
is
a
federally
recognized
Indian
tribe.
Dated:
October
15,
2002.
Linda
Garczynski,
Director,
Office
of
Brownfields
Cleanup
and
Redevelopment,
Office
of
Solid
Waste
and
Emergency
Response.
[FR
Doc.
02–
27126
Filed
10–
23–
02;
8:
45
am]
BILLING
CODE
6560–
50–
P
ENVIRONMENTAL
PROTECTION
AGENCY
[OPP–
2002–
0271;
FRL–
7276–
5]
Pesticide
Product
Registrations;
Conditional
Approval
AGENCY:
Environmental
Protection
Agency
(EPA).
ACTION:
Notice.
SUMMARY:
This
notice
announces
Agency
approval
of
an
application
submitted
by
Camas
Technologies,
Inc.,
to
conditionally
register
the
pesticide
product
Qwel
(CTI
13
19B)
Liquid
Concentrate
containing
a
new
active
ingredient
not
included
in
any
previously
registered
products
pursuant
to
the
provisions
of
section
3(
c)(
7)(
C)
of
the
Federal
Insecticide,
Fungicide,
and
Rodenticide
Act
(FIFRA),
as
amended.
FOR
FURTHER
INFORMATION
CONTACT:
Mary
L.
Waller,
Registration
Division
(7505C),
Office
of
Pesticide
Programs,
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460–
0001;
telephone
number:
(703)
308–
9354;
e
mail
address:
waller.
mary@
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
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–
0271.
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.
In
accordance
with
section
3(
c)(
2)
of
FIFRA,
a
copy
of
the
approved
label,
the
list
of
data
references,
the
data
and
other
scientific
information
used
to
support
registration,
except
for
material
specifically
protected
by
section
10
of
FIFRA,
are
also
available
for
public
inspection.
Requests
for
data
must
be
made
in
accordance
with
the
provisions
of
the
Freedom
of
Information
Act
and
must
be
addressed
to
the
Freedom
of
Information
Office
(A–
101),
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460–
0001.
The
request
should:
Identify
the
product
name
and
registration
number
and
specify
the
data
or
information
desired.
A
paper
copy
of
the
fact
sheet,
which
provides
more
detail
on
this
registration,
may
be
obtained
from
the
National
Technical
Information
Service
(NTIS),
5285
Port
Royal
Rd.,
Springfield,
VA
22161.
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/.
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
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16:
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65351
Federal
Register
/
Vol.
67,
No.
206
/
Thursday,
October
24,
2002
/
Notices
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.
Did
EPA
Conditionally
Approve
the
Application?
A
conditional
registration
may
be
granted
under
section
3(
c)(
7)(
C)
of
FIFRA
for
a
new
active
ingredient
where
certain
data
are
lacking,
on
condition
that
such
data
are
received
by
the
end
of
the
conditional
registration
period
and
do
not
meet
or
exceed
the
risk
criteria
set
forth
in
40
CFR
154.7;
that
use
of
the
pesticide
during
the
conditional
registration
period
will
not
cause
unreasonable
adverse
effects;
and
that
use
of
the
pesticide
is
in
the
public
interest.
The
Agency
has
considered
the
available
data
on
the
risks
associated
with
the
proposed
use
of
Macleaya
extract,
and
information
on
social,
economic,
and
environmental
benefits
to
be
derived
from
such
use.
Specifically,
the
Agency
has
considered
the
nature
and
its
pattern
of
use,
application
methods
and
rates,
and
level
and
extent
of
potential
exposure.
Based
on
these
reviews,
the
Agency
was
able
to
make
basic
health
and
safety
determinations
which
show
that
use
of
Macleaya
extract
during
the
period
of
conditional
registration
will
not
cause
any
unreasonable
adverse
effect
on
the
environment,
and
that
use
of
the
pesticide
is,
in
the
public
interest.
Consistent
with
section
3(
c)(
7)(
C)
of
FIFRA,
the
Agency
has
determined
that
these
conditional
registrations
are
in
the
public
interest.
Use
of
the
pesticides
are
of
significance
to
the
user
community,
and
appropriate
labeling,
use
directions,
and
other
measures
have
been
taken
to
ensure
that
use
of
the
pesticides
will
not
result
in
unreasonable
adverse
effects
to
man
and
the
environment.
III.
Conditionally
Approved
Registrations
EPA
issued
a
notice,
published
in
the
Federal
Register
of
January
19,
2000
(65
FR
2948)
(FRL–
6485–
1),
which
announced
that
Camas
Technologies,
Inc.,
P.
O.
Box
1357,
Broomfield,
CO
80038–
1357,
had
submitted
an
application
to
conditionally
register
the
pesticide
product,
Qwel
Fungicide
(EPA
File
Symbol
69876–
R),
containing
Macleaya
extract
at
1.5%
an
active
ingredient
not
included
in
any
previously
registered
product.
The
application
was
conditionally
approved
on
September
19,
2002,
as
Qwel
(CTI
13
19B)
Liquid
Concentrate,
an
end
use
product;
for
foliar
application
to
ornamental
crops
in
enclosed
greenhouses
for
the
control
of
powdery
mildew
and
Alternaria
and
Septoria
leaf
spots
(EPA
Registration
Number
69876–
1).
List
of
Subjects
Environmental
protection,
Pesticides
and
pest.
Dated:
October
6,
2002.
Debra
Edwards,
Acting
Director,
Registration
Division,
Office
of
Pesticide
Programs.
[FR
Doc.
02–
27128
Filed
10–
23–
02;
8:
45
am]
BILLING
CODE
6560–
50–
S
ENVIRONMENTAL
PROTECTION
AGENCY
[OPP–
2002–
0267;
FRL–
7276–
2]
Thymol
and
Eucalyptus
Oil;
Receipt
of
Application
for
Emergency
Exemption,
Solicitation
of
Public
Comment
AGENCY:
Environmental
Protection
Agency
(EPA).
ACTION:
Notice.
SUMMARY:
EPA
has
received
a
specific
exemption
request
from
the
Maine
Department
of
Agriculture,
Food,
and
Rural
Resources
to
use
the
pesticide
thymol
and
eucalyptus
oil
(CAS
numbers
89–
83–
8
and
8000–
48–
4,
respectively)
to
treat
up
to
13,000
hives
of
honey
and
beeswax
to
control
Varroa
mite.
The
Applicant
proposes
the
use
of
the
new
chemical,
eucalyptus
oil
which
has
not
been
registered
by
EPA
and
the
Applicant
proposes
a
first
food
use
of
thymol.
EPA
is
soliciting
public
comment
before
making
the
decision
whether
or
not
to
grant
the
exemption.
DATES:
Comments,
identified
by
docket
ID
number
OPP–
2002–
0267,
must
be
received
on
or
before
November
8,
2002.
ADDRESSES:
Comments
may
be
submitted
electronically,
by
mail,
or
through
hand
delivery/
courier.
Follow
the
detailed
instructions
as
provided
in
Unit
I.
of
the
SUPPLEMENTARY
INFORMATION.
FOR
FURTHER
INFORMATION
CONTACT:
Barbara
Madden,
Registration
Division
(7505C),
Office
of
Pesticide
Programs,
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460–
0001;
telephone
number:
(703)
305–
6463;
fax
number:
(703)
308–
5433;
e
mail
address:
Sec
18
Mailbox@
epamail.
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
a
federal
or
state
government
agency
involved
in
administration
of
environmental
quality
programs.
Potentially
affected
entities
may
include,
but
are
not
limited
to:
Federal
or
state
government
entity,
(NAICS
9241),
e.
g.,
Department
of
Agriculture,
Environment,
etc.
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.
To
determine
whether
you
or
your
business
may
be
affected
by
this
action,
you
should
carefully
examine
the
applicability
provisions
in
Unit
II.
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–
0267.
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/.
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,
''
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| epa | 2024-06-07T20:31:44.033076 | regulations | {
"license": "Public Domain",
"url": "https://downloads.regulations.gov/EPA-HQ-OPP-2002-0271-0001/content.txt"
} |
EPA-HQ-OPP-2002-0275-0001 | Notice | "2002-10-23T04:00:00" | Hydrogenated Starch Hydrolysate; Notice of Filing a Pesticide Petition to Establish an Exemption
from the Requirement of a Tolerance for a Certain Pesticide Chemical in or on Food | 65115
Federal
Register
/
Vol.
67,
No.
205
/
Wednesday,
October
23,
2002
/
Notices
Drinking
Water
(4607M),
1200
Pennsylvania
Avenue,
NW.,
Washington,
DC
20460
(e
mail:
kapadia.
amit@
epa.
gov;
Tel:
202–
564–
4879).
SUPPLEMENTARY
INFORMATION:
As
part
of
the
2002
appropriations
process,
Congress
directed
EPA
to
``
begin
immediately
to
review
the
Agency's
affordability
criteria
and
how
small
system
variance
and
exemption
programs
should
be
implemented
for
arsenic''
(Conference
Report
107–
272,
page
175).
Congress
further
directed
the
Agency
to
prepare
a
report,
which
EPA
submitted
(Report
to
Congress:
Small
System
Arsenic
Implementation
Issues:
EPA
815–
R–
02–
003),
``
on
its
review
of
the
affordability
criteria
and
the
administrative
actions
undertaken
or
planned
to
be
undertaken
by
the
Agency,
as
well
as
potential
funding
mechanisms
for
small
community
compliance
and
other
legislative
actions,
which,
if
taken
by
the
Congress,
would
best
achieve
appropriate
extensions
of
time
for
small
communities
while
also
guaranteeing
maximum
compliance.
''
(Conference
Report
107–
272,
page
175).
In
evaluating
treatment
technologies
for
small
systems,
EPA
currently
uses
an
affordability
threshold
of
2.5%
of
median
household
income.
EPA's
national
level
affordability
criteria
consist
of
two
major
components:
an
expenditure
baseline
and
an
affordability
threshold.
The
expenditure
baseline
(derived
from
annual
median
household
water
bills)
is
subtracted
from
the
affordability
threshold
(a
share
of
median
household
income
that
EPA
believes
to
be
a
reasonable
upper
limit
for
these
water
bills)
to
determine
the
expenditure
margin
(the
maximum
increase
in
household
water
bills
that
can
be
imposed
by
treatment
and
still
be
considered
affordable).
EPA
compares
the
cost
of
treatment
technologies
against
the
available
expenditure
margin
to
determine
if
an
affordable
compliance
technology
can
be
identified.
If
EPA
cannot
identify
an
affordable
compliance
technology,
then
it
attempts
to
identify
a
variance
technology.
Findings
must
be
made
at
both
the
Federal
and
State
level
that
compliance
technologies
are
not
affordable
for
small
systems
before
a
variance
can
be
granted.
EPA
is
asking
the
NDWAC
for
advice
on
its
national
level
affordability
criteria
and
the
methodology
used
to
establish
these
criteria.
Taking
into
consideration
the
structure
of
the
Safe
Drinking
Water
Act
and
the
limitations
of
readily
available
data
and
information
sources,
EPA
is
seeking
the
Council's
opinion
of
the
national
level
affordability
criteria,
methodology
for
deriving
the
criteria,
and
approach
to
applying
those
criteria
to
NPDWRs.
As
part
of
the
Council's
review
of
EPA's
national
level
affordability
criteria,
the
Agency
is
seeking
input
on
(1)
the
Agency's
overall
approach,
(2)
alternatives,
if
any,
to
the
use
of
median
household
income
as
a
metric,
(3)
alternatives,
if
any,
to
2.5%
as
a
metric,
(4)
alternatives,
if
any,
to
calculating
the
expenditure
baseline,
(5)
the
usefulness
of
a
separate
criteria
for
ground
and
surface
water
systems,
(6)
including
an
evaluation
of
the
potential
availability
of
financial
assistance,
and
(7)
the
need
for
making
affordability
determinations
on
a
regional
basis.
Other
issue
areas
may
also
be
discussed.
The
meeting
is
open
to
the
public;
statements
from
the
public
will
be
taken
at
the
close
of
the
meeting.
EPA
is
not
soliciting
written
comments
and
is
not
planning
to
formally
respond
to
comments.
This
will
be
the
third,
fourth,
and
fifth
work
group
meetings
on
this
topic.
At
the
first
meeting
held
on
September
11–
12
,
the
work
group
was
briefed
by
EPA
on
the
approach
to
affordability
taken
by
the
Agency.
At
the
first
meeting,
the
work
group
also
devised
an
approach
to
answer
the
Agency's
charge
questions.
For
the
second
work
group
meeting
(to
be
held
on
October
21–
22),
other
technical
experts
on
financial
assistance
have
been
invited
to
speak.
The
purpose
of
these
last
three
meetings
is
to
continue
the
workgroup
deliberations
and
to
draft
a
report
for
the
full
National
Drinking
Water
Advisory
Council.
Dated:
October
17,
2002.
Cynthia
C.
Dougherty,
Director,
Office
of
Ground
Water
and
Drinking
Water.
[FR
Doc.
02–
26994
Filed
10–
22–
02;
8:
45
am]
BILLING
CODE
6560–
50–
P
ENVIRONMENTAL
PROTECTION
AGENCY
[OPP–
2002–
0275;
FRL–
7276–
8]
Hydrogenated
Starch
Hydrolysate;
Notice
of
Filing
a
Pesticide
Petition
to
Establish
an
Exemption
From
the
Requirement
of
a
Tolerance
for
a
Certain
Pesticide
Chemical
in
or
on
Food
AGENCY:
Environmental
Protection
Agency
(EPA).
ACTION:
Notice.
SUMMARY:
This
notice
announces
the
initial
filing
of
a
pesticide
petition
proposing
the
establishment
of
regulations
for
residues
of
a
certain
pesticide
chemical
in
or
on
various
food
commodities.
DATES:
Comments,
identified
by
docket
ID
number
OPP–
2002–
0275
must
be
received
on
or
before
November
22,
2002.
ADDRESSES:
Comments
may
be
submitted
electronically,
by
mail,
or
through
hand
delivery/
courier.
Follow
the
detailed
instructions
as
provided
in
Unit
I.
of
the
SUPPLEMENTARY
INFORMATION.
FOR
FURTHER
INFORMATION
CONTACT:
Treva
Alston,
Registration
Division
(7505C),
Office
of
Pesticide
Programs,
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460–
0001;
telephone
number:
(703)
308–
8373;
e
mail
address:
alston.
treva@
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
categories
and
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
affected
by
this
action.
Other
types
of
entities
not
listed
in
the
table
could
also
be
affected.
The
North
American
Industrial
Classification
System
(NAICS)
codes
have
been
provided
to
assist
you
and
others
in
determining
whether
or
not
this
action
might
apply
to
certain
entities.
If
you
have
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
ID
number
OPP–
2002–
0275.
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
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65116
Federal
Register
/
Vol.
67,
No.
205
/
Wednesday,
October
23,
2002
/
Notices
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/.
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.
Certain
types
of
information
will
not
be
placed
in
the
EPA
Dockets.
Information
claimed
as
CBI
and
other
information
whose
disclosure
is
restricted
by
statute,
which
is
not
included
in
the
official
public
docket,
will
not
be
available
for
public
viewing
in
EPA's
electronic
public
docket.
EPA's
policy
is
that
copyrighted
material
will
not
be
placed
in
EPA's
electronic
public
docket
but
will
be
available
only
in
printed,
paper
form
in
the
official
public
docket.
To
the
extent
feasible,
publicly
available
docket
materials
will
be
made
available
in
EPA's
electronic
public
docket.
When
a
document
is
selected
from
the
index
list
in
EPA
Dockets,
the
system
will
identify
whether
the
document
is
available
for
viewing
in
EPA's
electronic
public
docket.
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.
EPA
intends
to
work
towards
providing
electronic
access
to
all
of
the
publicly
available
docket
materials
through
EPA's
electronic
public
docket.
For
public
commenters,
it
is
important
to
note
that
EPA's
policy
is
that
public
comments,
whether
submitted
electronically
or
in
paper,
will
be
made
available
for
public
viewing
in
EPA's
electronic
public
docket
as
EPA
receives
them
and
without
change,
unless
the
comment
contains
copyrighted
material,
CBI,
or
other
information
whose
disclosure
is
restricted
by
statute.
When
EPA
identifies
a
comment
containing
copyrighted
material,
EPA
will
provide
a
reference
to
that
material
in
the
version
of
the
comment
that
is
placed
in
EPA's
electronic
public
docket.
The
entire
printed
comment,
including
the
copyrighted
material,
will
be
available
in
the
public
docket.
Public
comments
submitted
on
computer
disks
that
are
mailed
or
delivered
to
the
docket
will
be
transferred
to
EPA's
electronic
public
docket.
Public
comments
that
are
mailed
or
delivered
to
the
docket
will
be
scanned
and
placed
in
EPA's
electronic
public
docket.
Where
practical,
physical
objects
will
be
photographed,
and
the
photograph
will
be
placed
in
EPA's
electronic
public
docket
along
with
a
brief
description
written
by
the
docket
staff.
C.
How
and
To
Whom
Do
I
Submit
Comments?
You
may
submit
comments
electronically,
by
mail,
or
through
hand
delivery/
courier.
To
ensure
proper
receipt
by
EPA,
identify
the
appropriate
docket
ID
number
in
the
subject
line
on
the
first
page
of
your
comment.
Please
ensure
that
your
comments
are
submitted
within
the
specified
comment
period.
Comments
received
after
the
close
of
the
comment
period
will
be
marked
``
late.
''
EPA
is
not
required
to
consider
these
late
comments.
If
you
wish
to
submit
CBI
or
information
that
is
otherwise
protected
by
statute,
please
follow
the
instructions
in
Unit
I.
D.
Do
not
use
EPA
Dockets
or
e
mail
to
submit
CBI
or
information
protected
by
statute.
1.
Electronically.
If
you
submit
an
electronic
comment
as
prescribed
in
this
unit,
EPA
recommends
that
you
include
your
name,
mailing
address,
and
an
email
address
or
other
contact
information
in
the
body
of
your
comment.
Also
include
this
contact
information
on
the
outside
of
any
disk
or
CD
ROM
you
submit,
and
in
any
cover
letter
accompanying
the
disk
or
CD
ROM.
This
ensures
that
you
can
be
identified
as
the
submitter
of
the
comment
and
allows
EPA
to
contact
you
in
case
EPA
cannot
read
your
comment
due
to
technical
difficulties
or
needs
further
information
on
the
substance
of
your
comment.
EPA's
policy
is
that
EPA
will
not
edit
your
comment,
and
any
identifying
or
contact
information
provided
in
the
body
of
a
comment
will
be
included
as
part
of
the
comment
that
is
placed
in
the
official
public
docket,
and
made
available
in
EPA's
electronic
public
docket.
If
EPA
cannot
read
your
comment
due
to
technical
difficulties
and
cannot
contact
you
for
clarification,
EPA
may
not
be
able
to
consider
your
comment.
i.
EPA
Dockets.
Your
use
of
EPA's
electronic
public
docket
to
submit
comments
to
EPA
electronically
is
EPA's
preferred
method
for
receiving
comments.
Go
directly
to
EPA
Dockets
at
http://
www.
epa.
gov/
edocket,
and
follow
the
online
instructions
for
submitting
comments.
Once
in
the
system,
select
``
search,
''
and
then
key
in
docket
ID
number
OPP–
2002–
0275.
The
system
is
an
``
anonymous
access''
system,
which
means
EPA
will
not
know
your
identity,
e
mail
address,
or
other
contact
information
unless
you
provide
it
in
the
body
of
your
comment.
ii.
E
mail.
Comments
may
be
sent
by
e
mail
to
opp
docket@
epa.
gov,
Attention:
Docket
ID
Number
OPP–
2002–
0275.
In
contrast
to
EPA's
electronic
public
docket,
EPA's
e
mail
system
is
not
an
``
anonymous
access''
system.
If
you
send
an
e
mail
comment
directly
to
the
docket
without
going
through
EPA's
electronic
public
docket,
EPA's
e
mail
system
automatically
captures
your
e
mail
address.
E
mail
addresses
that
are
automatically
captured
by
EPA's
e
mail
system
are
included
as
part
of
the
comment
that
is
placed
in
the
official
public
docket,
and
made
available
in
EPA's
electronic
public
docket.
iii.
Disk
or
CD
ROM.
You
may
submit
comments
on
a
disk
or
CD
ROM
that
you
mail
to
the
mailing
address
identified
in
Unit
I.
C.
2.
These
electronic
submissions
will
be
accepted
in
WordPerfect
or
ASCII
file
format.
Avoid
the
use
of
special
characters
and
any
form
of
encryption.
2.
By
mail.
Send
your
comments
to:
Public
Information
and
Records
Integrity
Branch
(PIRIB)
(7502C),
Office
of
Pesticide
Programs
(OPP),
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460–
0001,
Attention:
Docket
ID
Number
OPP–
2002–
0275.
3.
By
hand
delivery
or
courier.
Deliver
your
comments
to:
Public
Information
and
Records
Integrity
Branch
(PIRIB),
Office
of
Pesticide
Programs
(OPP),
Environmental
Protection
Agency,
Rm.
119,
Crystal
Mall
#2,
1921
Jefferson
Davis
Hwy.,
Arlington,
VA,
Attention:
Docket
ID
Number
OPP–
2002–
0275.
Such
deliveries
are
only
accepted
during
the
docket's
normal
hours
of
operation
as
identified
in
Unit
I.
B.
1.
D.
How
Should
I
Submit
CBI
to
the
Agency?
Do
not
submit
information
that
you
consider
to
be
CBI
electronically
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205
/
Wednesday,
October
23,
2002
/
Notices
through
EPA's
electronic
public
docket
or
by
e
mail.
You
may
claim
information
that
you
submit
to
EPA
as
CBI
by
marking
any
part
or
all
of
that
information
as
CBI
(if
you
submit
CBI
on
disk
or
CD
ROM,
mark
the
outside
of
the
disk
or
CD
ROM
as
CBI
and
then
identify
electronically
within
the
disk
or
CD
ROM
the
specific
information
that
is
CBI).
Information
so
marked
will
not
be
disclosed
except
in
accordance
with
procedures
set
forth
in
40
CFR
part
2.
In
addition
to
one
complete
version
of
the
comment
that
includes
any
information
claimed
as
CBI,
a
copy
of
the
comment
that
does
not
contain
the
information
claimed
as
CBI
must
be
submitted
for
inclusion
in
the
public
docket
and
EPA's
electronic
public
docket.
If
you
submit
the
copy
that
does
not
contain
CBI
on
disk
or
CD
ROM,
mark
the
outside
of
the
disk
or
CD
ROM
clearly
that
it
does
not
contain
CBI.
Information
not
marked
as
CBI
will
be
included
in
the
public
docket
and
EPA's
electronic
public
docket
without
prior
notice.
If
you
have
any
questions
about
CBI
or
the
procedures
for
claiming
CBI,
please
consult
the
person
listed
under
FOR
FURTHER
INFORMATION
CONTACT.
E.
What
Should
I
Consider
as
I
Prepare
My
Comments
for
EPA?
You
may
find
the
following
suggestions
helpful
for
preparing
your
comments:
1.
Explain
your
views
as
clearly
as
possible.
2.
Describe
any
assumptions
that
you
used.
3.
Provide
copies
of
any
technical
information
and/
or
data
you
used
that
support
your
views.
4.
If
you
estimate
potential
burden
or
costs,
explain
how
you
arrived
at
the
estimate
that
you
provide.
5.
Provide
specific
examples
to
illustrate
your
concerns.
6.
Make
sure
to
submit
your
comments
by
the
deadline
in
this
notice.
7.
To
ensure
proper
receipt
by
EPA,
be
sure
to
identify
the
docket
ID
number
assigned
to
this
action
in
the
subject
line
on
the
first
page
of
your
response.
You
may
also
provide
the
name,
date,
and
Federal
Register
citation.
II.
What
Action
is
the
Agency
Taking?
EPA
has
received
a
pesticide
petition
as
follows
proposing
the
establishment
and/
or
amendment
of
regulations
for
residues
of
a
certain
pesticide
chemical
in
or
on
various
food
commodities
under
section
408
of
the
Federal
Food,
Drug,
and
Cosmetic
Act
(FFDCA),
21
U.
S.
C.
346a.
EPA
has
determined
that
this
petition
contains
data
or
information
regarding
the
elements
set
forth
in
FFDCA
section
408(
d)(
2);
however,
EPA
has
not
fully
evaluated
the
sufficiency
of
the
submitted
data
at
this
time
or
whether
the
data
support
granting
of
the
petition.
Additional
data
may
be
needed
before
EPA
rules
on
the
petition.
List
of
Subjects
Environmental
protection,
Agricultural
commodities,
Feed
additives,
Food
additives,
Pesticides
and
pests,
Reporting
and
recordkeeping
requirements.
Dated:
October
9,
2002.
Debra
Edwards,
Acting
Director,
Registration
Division,
Office
of
Pesticide
Programs.
Summary
of
Petition
The
petitioner
summary
of
the
pesticide
petition
is
printed
below
as
required
by
FFDCA
section
408(
d)(
3).
The
summary
of
the
petition
was
prepared
by
the
petitioner,
and
represents
the
view
of
the
petitioner.
The
petition
summary
announces
the
availability
of
a
description
of
the
analytical
methods
available
to
EPA
for
the
detection
and
measurement
of
the
pesticide
chemical
residues
or
an
explanation
of
why
no
such
method
is
needed.
Hydrogenated
Starch
Hydrolysate
PP
2E6503
EPA
has
received
a
pesticide
petition
(2E6503)
from
Grain
Processing
Corporation,
1600
Oregon
Street,
Muscatine,
Iowa
52761
proposing,
pursuant
to
section
408(
d)
of
the
FFDCA,
21
U.
S.
C.
346a(
d),
to
amend
40
CFR
part
180
to
establish
an
exemption
from
the
requirement
of
a
tolerance
for
hydrogenated
starch
hydrolysate
(HSH)
in
or
on
growing
crops
or
when
applied
to
the
raw
agricultural
commodity
after
harvest.
EPA
has
determined
that
the
petition
contains
data
or
information
regarding
the
elements
set
forth
in
section
408(
d)(
2)
of
the
FFDCA;
however,
EPA
has
not
fully
evaluated
the
sufficiency
of
the
submitted
data
at
this
time
or
whether
the
data
support
granting
of
the
petition.
Additional
data
may
be
needed
before
EPA
rules
on
the
petition.
A.
Residue
Chemistry
1.
Plant
metabolism.
Like
any
other
carbohydrate,
HSH
degrades
readily
in
the
soil
and
other
substrates
into
carbon
dioxide
and
water.
HSH
(CAS
number
68425–
17–
2)
is
a
carbohydrate
polymer
with
a
theoretical
molecular
weight
(in
amu)
of
1,000–
3,600.
It
can
be
supplied
as
a
liquid
syrup
or
white
powder.
The
empirical
formula
of
the
components
of
HSH
are:
Components
Formula
Sorbitol
C6H14O6
Maltitol
C12H24O11
Hydrogenated
polysaccharides
C12H24O11
plus
C6H10O5
for
each
additional
glucose
moiety
in
the
chain
HSH
is
highly
soluble
in
water.
The
aqueous
solution
has
a
pH
range
of
4.0–
6.0.
It
hydrolyzes
slowly
to
glucose
and
sorbitol.
It
combusts
at
300
0
C
to
carbon
dioxide
and
water.
2.
Analytical
method.
The
qualitative
analysis
of
HSH
in
the
products
to
which
it
has
been
added
may
be
accomplished
by
extraction
of
the
sorbitol
and
maltitol
moieties
with
appropriate
solvents,
followed
by
gas
chromatography
of
the
extracts.
Similarly,
the
quantity
of
HSH
occurring
in
food
may
be
estimated
by
determining
the
amount
of
maltitol
recovered
and
applying
an
appropriate
factor.
Information
on
the
sensitivity
and
reproducibility
of
the
method
has
also
been
developed.
3.
Magnitude
of
residues.
HSH
is
readily
degraded
by
microorganisms
on
leaf
surfaces
and
in
the
soil.
Due
to
the
solubility
of
this
carbohydrate,
rain,
or
other
water
sources
wash
the
carbohydrate
into
the
soil
where
it
is
degraded
by
microorganisms
into
carbon
dioxide
and
water.
No
harmful
residues
are
produced.
B.
Toxicological
Profile
HSH
has
been
widely
used
in
foods
since
the
early
1980s.
It
has
been
marketed
extensively
by
Roquette,
Lonza
and
SPI
Polyols
for
years.
Grain
Processing
Corporation
produces
HSH
using
a
process
that
is
equivalent
to
the
process
petitioned
to
the
Food
and
Drug
Administration
by
Lonza
and
Roquette
Freres
for
GRAS
(generally
recognized
as
safe)
affirmation.
In
support
of
the
safety
of
our
HSH,
Grain
Processing
Corporation
and
SPI
Polyols
cites
data
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/
Vol.
67,
No.
205
/
Wednesday,
October
23,
2002
/
Notices
submitted
by
Roquette
in
its
Lycasin
80/
55
petition
regarding
numerous
studies
relating
to
the
safety
of
the
ingredient,
including
reports
on:
Digestion,
absorption,
distribution
and
excretion;
acute
oral
toxicity,
subchronic
toxicity,
genotoxicity,
reproduction,
biological
tolerance,
human
exposure,
and
laxation
effects.
1.
Acute
toxicity.
The
acute
oral
toxicity
of
HSH
has
been
evaluated.
The
acute
oral
lethal
dose
(LD50)
of
HSH
is
greater
than
10
grams/
kilogram
(g/
kg).
2.
Genotoxicty.
As
stated
in
Roquette's
GRAS
submission
of
Lycasin
80/
55,
HSH
is
nonmutagenic
and
nonclastogenic
in
short
term
in
vivo,
and
in
vitro
studies.
3.
Reproductive
and
developmental
toxicity.
Again
as
noted
in
Roquette's
GRAS
submission
of
Lycasin
80/
55
HSH
products,
when
administered
to
rats
over
3
generations,
produce
no
significant
effects
on
reproduction.
4.
Subchronic
toxicity.
In
Roquette's
GRAS
submission
for
Lycasin
80/
55,
it
is
noted
that
when
administered
orally
to
rats
and
dogs
in
amounts
of
5
g/
kg
to
15
g/
kg
of
body
weight
per
day
for
90
days,
HSH
produced
no
toxicologically
meaningful
effects
which
could
not
be
accounted
for
by
the
presence
of
sorbitol.
The
possible
treatment
related
effects
are
aggregates
in
the
renal
pelvis
of
some
rats,
diarrhea
in
most
dogs,
and
minimal
ectasia
in
the
renule
tubules
of
some
dogs.
5.
Chronic
toxicity.
HSH
is
used
extensively
in
foods.
Grain
Processing
Corporation
is
not
aware
of
any
chronic
toxic
effects
associated
with
this
product.
6.
Animal
metabolism.
The
GRAS
submission
for
Lycasin
80/
55
developed
by
Roquette
Freres
states
that
over
96%
of
HSH
(Lycasin
80/
55)
is
broken
down
by
the
mammalian
digestive
system
into
the
GRAS
substances,
glucose
and
sorbitol,
the
remaining
4%
is
in
the
form
of
maltitol.
One
half
of
the
maltitol
is
excreted
in
the
feces
and
the
majority
of
the
remainder
is
excreted
in
the
urine.
Within
the
first
2
hours
after
oral
administration
of
HSH
(Lycasin
80/
55),
virtually
all
of
the
glucose
to
glucose
bonds
are
broken
down
in
the
digestive
system,
producing
a
resulting
mixture
of
glucose,
sorbitol,
and
maltitol.
Within
7
hours,
95%
of
the
total
maltitol,
is
broken
down
into
glucose
and
sorbitol.
Of
the
remaining
5%
of
maltitol,
2%
is
found
in
the
digestive
tube
and
fecal
contents,
less
than
1%
is
found
in
the
plasma,
and
approximately
1%
is
excreted
in
the
urine.
There
is
no
accumulation
of
maltitol
in
the
plasma,
liver,
kidneys,
or
spleen
of
rats
fed
13.5
g/
kg/
day
of
Lycasin
80/
55
for
10
days
irrespective
of
whether
measurements
are
made
12
hours
or
10
days
after
cessation
of
dosing.
Lycasin
80/
55
at
the
dose
levels
tested,
30
to
180
grams
per
day,
produces
no
significant
variations
in
the
clinical
chemical,
hematological
or
urinary
profile
of
humans
with
the
exception
of
glucose
and
insulin
peaks
which
are
less
than
50%
of
those
produced
by
equivalent
amounts
of
glucose,
and
50
to
90%
of
those
produced
by
sucrose.
The
only
significant
clinical
effects
are
flatulence
and
diarrhea,
which
can
be
accounted
for
by
the
presence
of
free
and
bound
sorbitol.
The
mean
laxative
threshold
in
adult
males
is
approximately
180
grams
per
day,
while
in
females
the
threshold
is
approximately
100
grams
per
day.
In
children,
the
threshold
is
approximately
60
grams
per
day,
about
half
that
of
adults.
7.
Metabolite
toxicology.
None
of
the
metabolites
of
HSH
are
considered
to
be
of
toxicological
significance
for
the
use
of
this
product
as
a
pesticide
inert
ingredient.
8.
Endocrine
disruption.
Grain
Processing
Corporation
is
not
aware
of
any
endocrine
disruption
with
the
use
of
this
product.
C.
Aggregate
Exposure
1.
Dietary
exposure.
This
product
is
already
used
extensively
in
foods.
Studies
have
shown
that
it
is
safe
even
when
consumed
at
levels
of
up
to
100
g/
day.
i.
Food.
As
a
pesticide
inert
ingredient
HSH
will
not
result
in
any
harmful
exposure.
The
proposed
use
will
not
result
in
any
dietary
exposure
beyond
what
is
currently
present
in
commonly
consumed
foods.
ii.
Drinking
water.
There
is
no
anticipated
human
exposure
to
HSH
through
drinking
water.
HSH
is
expected
to
be
degraded
by
soil
microorganisms
to
carbon
dioxide
and
water
before
it
reaches
surface
or
ground
water.
Moreover,
in
water,
HSH
hydrolyses
to
glucose
and
sorbitol.
2.
Non
dietary
exposure.
No
significant
non
dietary
human
exposure
to
HSH
is
anticipated.
D.
Cumulative
Effects
HSH
is
a
widely
used
food
ingredient,
is
readily
digested
by
humans,
and
there
are
no
cumulative
effects.
Except
for
possible
occupational
exposure
of
the
pesticide
mixer/
loader/
applicator,
the
proposed
use
of
HSH
will
not
result
in
the
exposure
of
other
persons.
E.
Safety
Determination
1.
U.
S.
population.
The
proposed
use
of
HSH
does
not
pose
a
safety
concern
for
the
U.
S.
population
due
to
the
nontoxic
nature
of
the
compound
and
the
absence
of
exposure.
2.
Infants
and
children.
Infants
and
children
will
not
be
exposed
to
HSH
from
its
proposed
use
as
a
pesticide
inert
ingredient.
F.
International
Tolerances
Grain
Processing
Corporation
is
unaware
of
any
international
tolerances
for
this
product.
HSH
was
developed
by
a
Swedish
company
in
the
1960's
and
has
been
widely
used
by
the
food
industry
for
many
years,
especially
in
confectionery
products.
Roquette's
petition
indicates
that
Roquette's
Lycasin
products
have
been
approved
for
use
in
food
in
Europe
since
1963,
as
indicated
below.
Country
Year
of
Approval
Sweden
1963
(reaffirmed
in
1975)
Switzerland
1968
Norway
1975
Finland
1975
(reaffirmed
in
1980)
Denmark
1976
[FR
Doc.
02–
26993
Filed
10–
22–
02;
8:
45
am]
BILLING
CODE
6560–
50–
S
ENVIRONMENTAL
PROTECTION
AGENCY
[OPP–
2002–
0188;
FRL–
7199–
7]
Availability
of
the
Risk
Assessments
on
FQPA
Tolerance
Reassessment
Progress
and
Tolerance
Reassessment
Decision
(TRED)
for
Hexazinone
AGENCY:
Environmental
Protection
Agency
(EPA).
ACTION:
Notice.
SUMMARY:
This
notice
announces
the
availability
of
EPA's
tolerance
reassessment
decision
and
related
documents
for
hexazinone
including
the
Hexazinone
Overview,
Hexazinone
Summary,
Hexazinone
Decision
Document
(TRED),
and
supporting
risk
assessment
documents.
EPA
has
reassessed
the
25
tolerances,
or
legal
limits,
for
residues
of
hexazinone
in
or
on
raw
agricultural
commodities.
These
tolerances
are
now
considered
safe
under
the
Federal
Food,
Drug,
and
Cosmetic
Act
(FFDCA),
as
amended
by
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| epa | 2024-06-07T20:31:44.037971 | regulations | {
"license": "Public Domain",
"url": "https://downloads.regulations.gov/EPA-HQ-OPP-2002-0275-0001/content.txt"
} |
EPA-HQ-OPP-2002-0276-0001 | Rule | "2002-12-26T05:00:00" | Urea; Revocation of Tolerance Exemptions | 78713
Federal
Register
/
Vol.
67,
No.
248
/
Thursday,
December
26,
2002
/
Rules
and
Regulations
DEPARTMENT
OF
LABOR
Mine
Safety
and
Health
Administration
30
CFR
Parts
48
and
75
RIN
1219
A33
Emergency
Temporary
Standard;
Correction
AGENCY:
Mine
Safety
and
Health
Administration
(
MSHA),
Labor.
ACTION:
Emergency
Temporary
Standard;
correction.
SUMMARY:
This
document
corrects
errors
that
appeared
in
MSHA's
preamble
for
Emergency
Evacuations;
Emergency
Final
Rule.
EFFECTIVE
DATE:
December
26,
2002.
FOR
FURTHER
INFORMATION
CONTACT:
Marvin
W.
Nichols,
Jr.,
Director,
Office
of
Standards,
Regulations,
and
Variances,
MSHA,
(
202)
693
9440.
SUPPLEMENTARY
INFORMATION:
On
December
12,
2002,
we
(
MSHA)
published
in
the
Federal
Register
(
67
FR
76658)
an
Emergency
Temporary
Standard
on
Emergency
Evacuations.
In
a
separate
document,
the
Office
of
the
Federal
Register
has
corrected
a
printing
error
in
the
regulatory
text:
On
p.
76665,
third
column,
next
to
last
line
of
the
last
paragraph,
the
Federal
Register
has
corrected
``(
a)(
1)''
to
read
``(
a)(
1)
through
(
4)''.
The
preamble
contained
errors;
therefore,
we
are
correcting
the
preamble
to
the
rule
as
follows:
1.
On
p.
76659,
third
column,
last
line,
change
``
determined''
to
``
concluded''.
2.
On
p.
76660,
first
column,
17th
&
18th
lines,
correct
``
report
concluded''
to
read
``
team
also
determined''.
3.
On
p.
76662,
first
column,
8th
line
in
second
full
paragraph
beginning
with
``
Because'',
correct
``(
a)(
1)
through
(
3)''
to
read
``(
a)(
1)(
i)
through
(
iii)''.
Dated:
December
19,
2002.
John
R.
Caylor,
Deputy
Assistant
Secretary
of
Labor
for
Mine
Safety
and
Health.
[
FR
Doc.
02
32583
Filed
12
24
02;
8:
45
am]
BILLING
CODE
4510
43
P
ENVIRONMENTAL
PROTECTION
AGENCY
40
CFR
Part
180
[
OPP
2002
0276;
FRL
7284
3]
Urea:
Revocation
of
Tolerance
Exemptions
AGENCY:
Environmental
Protection
Agency
(
EPA).
ACTION:
Direct
Final
rule.
SUMMARY:
EPA
is
amending
40
CFR
part
180
subpart
D
to
revoke
four
exemptions
from
the
requirement
of
a
tolerance
for
urea
because
these
tolerance
exemptions
are
no
longer
necessary.
The
Agency
is
acting
on
its
own
initiative.
This
direct
final
rule
is
being
published
today
with
a
companion
final
rule
titled
``
Urea:
Exemption
From
The
Requirement
of
A
Tolerance.''
DATES:
This
final
rule
is
effective
on
March
26,
2003
without
further
notice,
unless
EPA
receives
adverse
comment
within
30
days
after
publication
in
the
Federal
Register.
If
EPA
receives
adverse
comment,
EPA
will
publish
a
timely
withdrawal
in
the
Federal
Register
informing
the
public
that
this
rule
will
not
take
effect.
FOR
FURTHER
INFORMATION
CONTACT:
Treva
C.
Alston,
Registration
Division
7505C,
Office
of
Pesticide
Programs,
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460;
telephone
number:
(
703)
308
8373;
e
mail
address:
alston.
treva@
epa.
gov.
SUPPLEMENTARY
INFORMATION:
I.
General
Information
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:
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
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
0276.
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.
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
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.
Authority
A.
What
is
the
Agency's
Authority
for
Taking
this
Action?
This
direct
final
rule
is
issued
pursuant
to
section
408(
e)
of
the
Federal
Food
Drug
and
Cosmetic
Act
(
FFDCA),
as
amended
by
the
Food
Quality
Proctection
Act
(
FQPA)
(
21
U.
S.
C.
346a(
e)).
Section
408
of
FFDCA
authorizes
the
establishment
of
tolerances,
exemptions
from
the
requirement
of
a
tolerance,
modifications
in
tolerances,
and
revocation
of
tolerances
for
residues
of
pesticide
chemicals
in
or
on
raw
agricultural
commodities
and
processed
foods.
Without
a
tolerance
or
tolerance
exemption,
food
containing
pesticide
residues
is
considered
to
be
unsafe
and
therefore,
``
adulterated''
under
section
402(
a)
of
the
FFDCA.
If
food
containing
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248
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2002
/
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and
Regulations
pesticide
residues
is
found
to
be
adulterated,
the
food
may
not
be
distributed
in
interstate
commerce
(
21
U.
S.
C.
331(
a)
and
342
(
a)).
B.
Why
is
EPA
Issuing
this
as
a
Direct
Final
Rule?
EPA
is
issuing
this
action
as
a
direct
final
rule
without
prior
proposal
because
the
Agency
believes
that
this
action
is
not
controversial
and
is
not
likely
to
result
in
any
adverse
comments.
This
action
removes
four
exemptions
from
the
requirement
of
a
tolerance
for
the
pesticide
chemical,
urea.
These
tolerance
exemptions
are
not
necessary.
III.
Background
A.
What
Action
is
the
Agency
Taking?
In
a
companion
final
rule
published
in
today's
Federal
Register,
the
Agency
discussed
the
reasons
and
rationale
for
establishing
a
tolerance
exemption
for
urea
in
40
CFR
180.950.
Given
the
establishment
of
this
unlimited
tolerance
exemption,
the
tolerance
exemptions
for
urea
in
40
CFR
180.1001
(
c),
(
d),
and
(
e)
and
180.1117
are
no
longer
needed.
Therefore,
the
Agency
is
removing
these
exemptions.
No
uses
are
lost
through
the
removal
of
these
tolerance
exemptions.
All
uses
are
covered
under
the
tolerance
exemption
established
today
in
40
CFR
180.950.
B.
Which
Tolerance
Exemptions
are
Being
Removed?
1.
In
40
CFR
180.1001
(
c)
and
(
e),
there
are
two
exemptions
from
the
requirement
of
a
tolerance
for
urea.
These
exemptions
are
restricted
to
use
as
a
stabilizer
and
inhibitor.
2.
There
is
an
exemption
from
the
requirement
of
a
tolerance
for
urea
in
40
CFR
180.1001
(
d).
This
exemption
is
for
its
use
as
an
adjuvant/
intensifer
for
herbicides.
3.
Another
exemption
from
the
requirement
of
a
tolerance
is
listed
in
40
CFR
180.1117.
This
tolerance
exemption
was
established
for
residues
of
urea
when
used
as
a
frost
protectant
in
or
on
the
following
raw
agricultural
commodities
when
used
before
harvest
in
the
production
of:
Alfalfa,
almonds,
apples,
apricots,
artichokes,
asparagus,
avocados,
beans,
bell
pepppers,
blackberries,
blueberries,
broccoli,
brussels
sprouts,
boysenberries,
craneberries,
canola,
cantaloupes,
carrots,
cauliflower,
casaba,
celery,
cherries,
chili
pepers,
chinese
cabbage
(
bok
choy,
napa),
cooking
peppers,
corn,
cotton,
crenshaw,
cucumbers,
figs,
grapefruit,
grapes,
honeydew
melon,
hops,
kiwifruit,
kohlrabi,
lemons,
lentils,
lettuce,
limes,
macadamia
nuts,
musk
melon,
nectarines,
olives,
onions,
oranges,
peaches,
pears,
peanuts,
peas,
persian
melon,
pistachios,
plums,
potatoes,
pumpkin,
prunes,
radish,
raspberries,
rice,
safflower,
sorghum,
spinach,
spinach
(
New
Zealand),
squash
(
winter
and
summer),
strawberries,
sugar
beets,
sunflower,
sweet
pepper,
table
beets,
tangerines,
tomatoes,
walnuts,
watermelon,
and
zucchini.
IV.
Statute
and
Executive
Order
Reviews
Under
Executive
Order
12866,
entitled
Planning
and
Review
(
58
FR
51735,
October
4,
1993),
it
has
been
determined
that
this
direct
final
rule
is
not
a
``
significant
regulatory
action''
under
section
3(
f)
of
the
Executive
Order,
because
EPA
is
removing
four
tolerance
exemptions
that
are
no
longer
necessary
given
the
publication
of
the
companion
final
rule
that
establishes
a
broader
tolerance
exemption
that
will
cover
these
four
tolerance
exemptions.
This
direct
final
rule
is
not
expected
to
have
any
adverse
impact
and
does
not
otherwise
impose
any
new
requirements.
Since
it
is
not
significant
under
Executive
Order
12866,
it
is
not
subject
to
review
by
the
Office
of
Management
and
Budget
(
OMB)
under
Executive
Order
13045,
entitled
Protection
of
Children
from
Environmental
Health
Risks
and
Safety
Risks
(
62
FR
19885,
April
23,
1997),
or
Executive
Order
13211,
entitled
Actions
Concerning
Regulations
That
Significantly
Affect
Energy
Supply,
Distribution,
or
Use
(
66
FR
28355,
May
22,
2001).
This
direct
final
rule
directly
regulates
food
processors,
food
handlers,
and
food
retailers,
but
does
not
affect
States,
local
or
Tribal
governments
directly.
This
action
does
not
alter
the
relationships
or
distribution
of
power
and
responsibilities
established
by
Congress
in
the
preemption
provisions
of
FFDCA
section
408(
n)(
4).
This
action
will
not
have
substantial
direct
effects
on
State
or
tribal
governments,
on
the
relationship
between
the
Federal
government
and
States
or
Indian
tribes,
or
on
the
distribution
of
power
and
responsibilities
between
the
Federal
government
and
States
or
Indian
tribes.
As
a
result,
this
action
does
not
require
any
action
under
Executive
Order
13132,
entitled
Federalism
(
64
FR
43255,
August
10,
1999),
or
under
Executive
Order
13175,
entitled
Consultation
and
Coordination
with
Indian
Tribal
Governments
(
65
FR
67249,
November
6,
2000).
Nor
does
it
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
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
Executive
Order
12630,
entitled
Governmental
Actions
and
Interference
with
Constitutionally
Protected
Property
Rights
(
53
FR
8859,
March
15,
1988).
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).
Under
section
605(
b)
of
the
Regulatory
Flexibility
Act
(
RFA)
(
5
U.
S.
C.
601
et
seq.),
the
Agency
hereby
certifies
that
these
revocations
will
not
have
significant
negative
economic
impact
on
a
substantial
number
of
small
entities.
The
rationale
supporting
this
conclusion
is
as
follows.
The
rationale
here
is
that
we
are
replacing
these
exemptions
with
a
broader
one.
V.
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
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
the
rule
in
the
Federal
Register.
This
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:
December
12,
2002.
Peter
Caulkins,
Acting
Director,
Registration
Division
Director,
Office
of
Pesticide
Programs.
Therefore,
40
CFR
chapter
I
is
amended
as
follows:
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248
/
Thursday,
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26,
2002
/
Rules
and
Regulations
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.
§
180.1001
[
Amended]
2.
In
subpart
D,
§
180.1001
is
amended
by:
i.
Removing
from
the
table
in
paragraph
(
c)
the
entry
for
urea
``
use
as
a
stabilizer
and
inhibitor.''
ii.
Removing
from
the
table
in
paragraph
(
d)
the
entry
for
urea
``
use
as
an
adjuvant/
intensifier
for
herbicides.''
iii.
Removing
from
the
table
in
paragraph
(
e)
the
entry
for
urea
``
use
as
a
stabilizer
and
inhibitor.''
§
180.1117
[
Removed]
3.
Section
180.1117
is
removed.
[
FR
Doc.
02
32563
Filed
12
24
02;
8:
45
a.
m.]
BILLING
CODE
6560
50
S
ENVIRONMENTAL
PROTECTION
AGENCY
40
CFR
Part
180
[
OPP
2002
0277;
FRL
7284
2]
Urea;
Exemption
from
the
Requirement
of
a
Tolerance
AGENCY:
Environmental
Protection
Agency
(
EPA).
ACTION:
Final
rule.
SUMMARY:
This
regulation
establishes
an
exemption
from
the
requirement
of
a
tolerance
for
residues
of
urea
when
used
in
pesticide
formulations.
Ecolab,
Inc.
submitted
a
petition
to
EPA
under
the
Federal
Food,
Drug,
and
Cosmetic
Act,
as
amended
by
the
Food
Quality
Protection
Act
of
1996,
requesting
an
exemption
from
the
requirement
of
a
tolerance.
This
regulation
eliminates
the
need
to
establish
a
maximum
permissible
level
for
residues
of
urea.
This
final
rule
is
being
published
in
today's
Federal
Register
with
a
companion
Direct
Final
Rule
entitled
``
Urea:
Revocation
of
Tolerance
Exemptions''
DATES:
This
regulation
is
effective
December
26,
2002.
Objections
and
requests
for
hearings,
identified
by
docket
ID
number
OPP
2002
0277,
must
be
received
on
or
before
February
24,
2003.
ADDRESSES:
Written
objections
and
hearing
requests
submitted
electronically,
by
mail,
or
through
hand
delivery/
courier.
Follow
the
detailed
instructions
as
provided
in
Unit
VIII.
of
the
SUPPLEMENTARY
INFORMATION.
FOR
FURTHER
INFORMATION
CONTACT:
Treva
C.
Alston,
Registration
Division
(
7505C),
Office
of
Pesticide
Programs,
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460
0001;
telephone
number:
(
703)
308
8373;
e
mail
address:
alston.
treva@
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
categories
and
entities
may
include,
but
are
not
limited
to:
Crop
production
(
NAICS
111)
Animal
production
(
NAICS
112)
Food
manufacturing
(
NAICS
311)
Pesticide
manufacturing
(
NAICS
32532)
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
table
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
0277.
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.
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
April
7,
2000
(
65
FR
18324)
(
FRL
6499
7),
EPA
issued
a
notice
pursuant
to
section
408
of
the
Federal
Food,
Drug,
and
Cosmetic
Act
(
FFDCA),
21
U.
S.
C.
346a,
as
amended
by
the
Food
Quality
Protection
Act
(
FQPA)
(
Public
Law
104
170),
announcing
the
filing
of
a
pesticide
tolerance
petition
(
PP
9E6028)
by
Ecolab,
Inc.,
370
N.
Wabasha
Street,
St.
Paul,
MN
55102.
This
notice
included
a
summary
of
the
petition
prepared
by
the
petitioner
Ecolab.
There
were
no
comments
received
in
response
to
the
notice
of
filing.
The
petition
requested
that
40
CFR
180.1001
be
amended
by
establishing
an
exemption
from
the
requirement
of
a
tolerance
for
residues
of
urea
in
or
on
raw
agricultural
commodities,
in
processed
commodities,
and
in
or
on
meat
and
meat
by
products
of
cattle,
sheep,
hogs,
goats,
horses,
poultry,
milk,
dairy
products,
eggs,
seafood
and
shellfish,
and
fruits
and
vegetables
when
such
residues
result
from
the
use
of
urea
as
a
component
of
a
food
contact
surface
sanitizing
solution
for
use
in
food
handling
establishments.
Section
408(
b)(
2)(
A)(
i)
of
the
FFDCA
allows
EPA
to
establish
an
exemption
from
the
requirement
for
a
tolerance
(
the
legal
limit
for
a
pesticide
chemical
residue
in
or
on
a
food)
only
if
EPA
determines
that
the
exemption
from
tolerance
is
``
safe.''
Section
408(
b)(
2)(
A)(
ii)
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
VerDate
Dec<
13>
2002
17:
05
Dec
24,
2002
Jkt
200001
PO
00000
Frm
00051
Fmt
4700
Sfmt
4700
E:\
FR\
FM\
26DER1.
SGM
26DER1
| epa | 2024-06-07T20:31:44.046845 | regulations | {
"license": "Public Domain",
"url": "https://downloads.regulations.gov/EPA-HQ-OPP-2002-0276-0001/content.txt"
} |
EPA-HQ-OPP-2002-0277-0001 | Rule | "2002-12-26T05:00:00" | Urea; Exemption from the Requirement of a Tolerance | 78715
Federal
Register
/
Vol.
67,
No.
248
/
Thursday,
December
26,
2002
/
Rules
and
Regulations
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.
§
180.1001
[
Amended]
2.
In
subpart
D,
§
180.1001
is
amended
by:
i.
Removing
from
the
table
in
paragraph
(
c)
the
entry
for
urea
``
use
as
a
stabilizer
and
inhibitor.''
ii.
Removing
from
the
table
in
paragraph
(
d)
the
entry
for
urea
``
use
as
an
adjuvant/
intensifier
for
herbicides.''
iii.
Removing
from
the
table
in
paragraph
(
e)
the
entry
for
urea
``
use
as
a
stabilizer
and
inhibitor.''
§
180.1117
[
Removed]
3.
Section
180.1117
is
removed.
[
FR
Doc.
02
32563
Filed
12
24
02;
8:
45
a.
m.]
BILLING
CODE
6560
50
S
ENVIRONMENTAL
PROTECTION
AGENCY
40
CFR
Part
180
[
OPP
2002
0277;
FRL
7284
2]
Urea;
Exemption
from
the
Requirement
of
a
Tolerance
AGENCY:
Environmental
Protection
Agency
(
EPA).
ACTION:
Final
rule.
SUMMARY:
This
regulation
establishes
an
exemption
from
the
requirement
of
a
tolerance
for
residues
of
urea
when
used
in
pesticide
formulations.
Ecolab,
Inc.
submitted
a
petition
to
EPA
under
the
Federal
Food,
Drug,
and
Cosmetic
Act,
as
amended
by
the
Food
Quality
Protection
Act
of
1996,
requesting
an
exemption
from
the
requirement
of
a
tolerance.
This
regulation
eliminates
the
need
to
establish
a
maximum
permissible
level
for
residues
of
urea.
This
final
rule
is
being
published
in
today's
Federal
Register
with
a
companion
Direct
Final
Rule
entitled
``
Urea:
Revocation
of
Tolerance
Exemptions''
DATES:
This
regulation
is
effective
December
26,
2002.
Objections
and
requests
for
hearings,
identified
by
docket
ID
number
OPP
2002
0277,
must
be
received
on
or
before
February
24,
2003.
ADDRESSES:
Written
objections
and
hearing
requests
submitted
electronically,
by
mail,
or
through
hand
delivery/
courier.
Follow
the
detailed
instructions
as
provided
in
Unit
VIII.
of
the
SUPPLEMENTARY
INFORMATION.
FOR
FURTHER
INFORMATION
CONTACT:
Treva
C.
Alston,
Registration
Division
(
7505C),
Office
of
Pesticide
Programs,
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460
0001;
telephone
number:
(
703)
308
8373;
e
mail
address:
alston.
treva@
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
categories
and
entities
may
include,
but
are
not
limited
to:
Crop
production
(
NAICS
111)
Animal
production
(
NAICS
112)
Food
manufacturing
(
NAICS
311)
Pesticide
manufacturing
(
NAICS
32532)
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
table
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
0277.
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.
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
April
7,
2000
(
65
FR
18324)
(
FRL
6499
7),
EPA
issued
a
notice
pursuant
to
section
408
of
the
Federal
Food,
Drug,
and
Cosmetic
Act
(
FFDCA),
21
U.
S.
C.
346a,
as
amended
by
the
Food
Quality
Protection
Act
(
FQPA)
(
Public
Law
104
170),
announcing
the
filing
of
a
pesticide
tolerance
petition
(
PP
9E6028)
by
Ecolab,
Inc.,
370
N.
Wabasha
Street,
St.
Paul,
MN
55102.
This
notice
included
a
summary
of
the
petition
prepared
by
the
petitioner
Ecolab.
There
were
no
comments
received
in
response
to
the
notice
of
filing.
The
petition
requested
that
40
CFR
180.1001
be
amended
by
establishing
an
exemption
from
the
requirement
of
a
tolerance
for
residues
of
urea
in
or
on
raw
agricultural
commodities,
in
processed
commodities,
and
in
or
on
meat
and
meat
by
products
of
cattle,
sheep,
hogs,
goats,
horses,
poultry,
milk,
dairy
products,
eggs,
seafood
and
shellfish,
and
fruits
and
vegetables
when
such
residues
result
from
the
use
of
urea
as
a
component
of
a
food
contact
surface
sanitizing
solution
for
use
in
food
handling
establishments.
Section
408(
b)(
2)(
A)(
i)
of
the
FFDCA
allows
EPA
to
establish
an
exemption
from
the
requirement
for
a
tolerance
(
the
legal
limit
for
a
pesticide
chemical
residue
in
or
on
a
food)
only
if
EPA
determines
that
the
exemption
from
tolerance
is
``
safe.''
Section
408(
b)(
2)(
A)(
ii)
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
VerDate
Dec<
13>
2002
17:
05
Dec
24,
2002
Jkt
200001
PO
00000
Frm
00051
Fmt
4700
Sfmt
4700
E:\
FR\
FM\
26DER1.
SGM
26DER1
78716
Federal
Register
/
Vol.
67,
No.
248
/
Thursday,
December
26,
2002
/
Rules
and
Regulations
information.''
This
includes
exposure
through
drinking
water
and
in
residential
settings,
but
does
not
include
occupational
exposure.
Section
408(
b)(
2)(
C)
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.
First,
EPA
determines
the
toxicity
of
pesticides.
Second,
EPA
examines
exposure
to
the
pesticide
through
food,
drinking
water,
and
through
other
exposures
that
occur
as
a
result
of
pesticide
use
in
residential
settings.
III.
Toxicological
Profile
Consistent
with
section
408(
b)(
2)(
D)
of
FFDCA,
EPA
has
reviewed
the
available
scientific
data
and
other
relevant
information
in
support
of
this
action
and
considered
its
validity,
completeness
and
reliability
and
the
relationship
of
this
information
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
urea
are
discussed
in
this
unit.
In
the
Federal
Register
of
April
15,
2002
(
67
FR
18197)
(
FRL
6860
6),
the
Agency
published
its
report
of
the
Tolerance
Reassessment
Decision
for
urea.
This
Report
contained
the
hazard
characterization
of
urea.
For
a
complete
description
of
the
use
summary,
hazard
characterization,
exposure
assessment
and
risk
assessment
findings,
see
the
Notice
of
April
15,
2002.
These
data
are
considered
by
the
Agency
to
be
sufficient
to
assess
the
potential
hazard
to
humans,
including
infants
and
children.
IV.
Summary
of
Risk
Assessment
Findings
From
the
available
animal
studies
and
other
data,
EPA
has
concluded
that
urea
exhibits
a
low
toxicity
and
exposures
to
urea
used
either
as
an
active
or
inert
pesticide
ingredient
present
a
reasonable
certainty
of
no
harm
to
human
health.
V.
Cumulative
Effects
Section
408(
b)(
2)(
D)(
v)
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.
Urea
is
a
low
toxicity
chemical.
EPA
does
not
have,
at
this
time,
available
data
to
determine
whether
urea
has
a
common
mechanism
of
toxicity
with
other
subtances
or
how
to
include
these
pesticide
chemicals
in
a
cumulative
risk
assessment.
VI.
Determination
of
Safety
for
U.
S.
Population,
Infants
and
Children
Based
on
the
available
data,
EPA
concludes
that
urea
does
not
pose
a
dietary
risk
under
reasonable
foreseeable
circumstances.
Accordingly,
EPA
finds
that
there
is
a
reasonable
certainty
that
no
harm
will
result
to
the
general
population,
and
to
infants
and
chldren
from
aggregate
exposure
to
urea.
Because
of
the
low
toxicity
of
urea,
a
safety
factor
analysis
has
not
been
used
to
assess
the
risk.
For
the
same
reason,
the
tenfold
safety
factor
for
the
protection
of
infants
and
children
is
unnecessary.
VII.
Other
Considerations
A.
Endocrine
Disruptors
FQPA
requires
EPA
to
develop
a
screening
program
to
determine
whether
certain
substances,
including
all
pesticide
chemicals
(
both
inert
and
active
ingredients),
may
have
an
effect
in
humans
that
is
similar
to
an
effect
produced
by
a
naturally
occurring
estrogen,
or
such
other
endocrine
effect.
EPA
has
been
working
with
interested
stakeholeders
to
develop
a
screening
and
testing
program
as
well
as
a
priority
setting
scheme.
As
the
Agency
proceeds
with
implementation
of
this
program,
further
testing
of
products
containing
urea
may
be
required.
B.
Analytical
Method(
s)
An
analytical
method
is
not
required
for
enforcement
purposes
since
the
Agency
is
establishing
an
exemption
from
the
requirement
of
a
tolerance
without
any
numerical
limitation.
C.
Existing
Tolerances
There
are
four
existing
tolerance
exemptions
for
urea.
They
are
as
follows:
§
180.1001(
c),
(
d),
and
(
e);
and
§
180.1117.
However,
in
today's
Federal
Register,
the
Agency,
acting
on
its
on
initiative,
published
a
direct
final
rule
revoking
these
four
tolerance
exemptions
as
they
are
no
longer
necessary.
No
uses
are
lost
by
revoking
the
above
four
tolerance
exemptions,
as
the
tolerance
exemption
established
in
this
rule
will
cover
these
uses
and
the
use
requested
by
the
petitioner.
D.
International
Tolerances
The
Agency
is
not
aware
of
any
country
requiring
a
tolerance
for
urea
nor
have
any
CODEX
Maximum
Residue
Levels
been
established
for
any
food
crops
at
this
time.
E.
List
4A
Classification
Based
on
its
low
toxicity,
urea
will
be
classified
as
a
List
4A
inert
ingredient.
List
4A
inert
ingredients
are
minimal
risk
inert
ingredients.
Minimal
risk
does
not
imply
no
risk
under
any
circumstances.
Every
substance
can
present
some
risk
in
certain
circumstances.
Minimal
risk
is
used
to
indicate
a
substance
for
which
there
is
no
information
to
indicate
that
there
is
a
basis
for
concern.
Thus,
the
tolerance
exemption
will
be
established
in
40
CFR
180.950
which
holds
minimal
risk
chemicals
instead
of
40
CFR
180.1001
as
requested
by
the
petitioner,
Ecolab.
VIII.
Conclusions
Based
on
the
information
in
the
record,
EPA
concludes
that
there
is
a
reasonable
certainty
of
no
harm
from
aggregate
exposure
to
residues
of
urea.
Accordingly,
EPA
finds
that
exempting
urea
from
the
requirement
of
a
tolerance
will
be
safe.
IX.
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
of
1996,
EPA
will
continue
to
use
those
procedures,
with
appropriate
adjustments,
until
the
necessary
modifications
can
be
made.
The
new
section
408(
g)
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),
as
was
provided
in
the
old
FFDCA
sections
408
and
409.
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
0277
in
the
subject
line
on
the
first
page
of
your
submission.
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/
Vol.
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No.
248
/
Thursday,
December
26,
2002
/
Rules
and
Regulations
requests
must
be
in
writing,
and
must
be
mailed
or
delivered
to
the
Hearing
Clerk
on
or
before
February
24,
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
IX.
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
0277,
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.
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).
X.
Regulatory
Assessment
Requirements
This
final
rule
establishes
an
exemption
from
the
tolerance
requirement
under
FFDCA
section
408(
d)
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,
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
FFDCA
section
408(
d),
such
as
the
tolerance
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
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Vol.
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248
/
Thursday,
December
26,
2002
/
Rules
and
Regulations
alter
the
relationships
or
distribution
of
power
and
responsibilities
established
by
Congress
in
the
preemption
provisions
of
FFDCA
section
408(
n)(
4).
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.
XI.
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:
December
12,
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
180.950
is
amended
by
adding
alphabetically
the
following
ingredient
to
the
table
in
paragraph
(
e)
to
read
as
follows.
§
180.950
Tolerance
exemptions
for
minimal
risk
active
and
inert
ingredients.
*
*
*
*
*
(
e)
*
*
*
Chemical
CAS
No.
*
*
*
*
*
Urea
...................................................................................................................................
57
13
6
[
FR
Doc.
02
32564
Filed
12
24
02;
8:
45
am]
BILLING
CODE
6560
50
S
ENVIRONMENTAL
PROTECTION
AGENCY
40
CFR
Part
261
[
FRL
7429
3]
RIN
2003
AA00
Regulatory
Innovations:
Pilot
Specific
Rule
for
Electronic
Materials
in
the
EPA
Region
III
Mid
Atlantic
States;
Hazardous
Waste
Management
System;
Modification
of
the
Hazardous
Waste
Program;
Cathode
Ray
Tubes
AGENCY:
Environmental
Protection
Agency.
ACTION:
Direct
final
rule.
SUMMARY:
Many
used
cathode
ray
tubes
(
CRTs)
are
currently
classified
as
characteristic
hazardous
wastes
under
the
Resource
Conservation
and
Recovery
Act
(
RCRA).
Such
CRTs
are
therefore
subject
to
the
hazardous
waste
regulations
of
RCRA
Subtitle
C
unless
they
come
from
a
household
or
a
conditionally
exempt
small
quantity
generator.
Today
EPA
is
taking
direct
final
action
on
a
revision
to
its
hazardous
waste
program
under
RCRA
to
exclude
used
CRTs
and
glass
removed
from
CRTs
from
the
definition
of
``
solid
waste''
in
the
EPA
Region
III
Mid
Atlantic
States
(
which
include
the
States
of
Delaware,
Maryland,
and
West
Virginia,
the
Commonwealths
of
Pennsylvania
and
Virginia,
and
the
District
of
Columbia).
Additionally,
the
preamble
to
this
rule
clarifies
when
used
CRTs
and
other
used
electronic
equipment
become
a
``
solid
waste.''
This
rule
will
support
an
ongoing
e
Cycling
Pilot
Project
of
EPA
Region
III's
Mid
Atlantic
States,
which
is
promoting
reuse
and
recycling
of
electronics.
EPA
believes
that
today's
direct
final
rule
will
encourage
increased
recycling
and
better
management
of
these
materials
in
Region
III
states.
EPA
has
proposed
a
similar,
albeit
broader,
conditional
exclusion
for
CRTs
and
certain
other
electronic
materials
that
would
be
effective
nationwide
(
June
12,
2002,
67
FR
40508
40528).
EPA
is
promulgating
this
regional
rule
now
because
it
believes
that
implementing
the
rule
in
the
Region
III
states
will
produce
information
about
the
CRT
conditional
exclusion
that
will
be
useful
to
EPA
as
it
assesses
the
appropriateness
of
adopting
the
RCRA
exclusion
nationally.
EPA
expects
to
withdraw
the
regional
rule
if
and
when
a
final
national
rule
becomes
effective.
DATES:
This
direct
final
rule
is
effective
on
February
24,
2003
without
further
notice,
unless
EPA
receives
adverse
comment
by
January
27,
2003.
If
we
receive
such
comment,
EPA
will
publish
a
timely
withdrawal
in
the
Federal
Register
informing
the
public
that
this
rule
will
not
take
effect.
ADDRESSES:
Comments
may
be
submitted
by
mail
or
electronically.
Commenters
must
send
an
original
and
two
copies
of
their
comments
referencing
docket
number
III
02
OEI
01
to:
Marie
Holman
(
3EI00),
U.
S.
EPA
Region
III,
Office
of
Environmental
Innovation,
1650
Arch
Street,
Philadelphia,
PA
19103
2029
or
holman.
marie@
epa.
gov.
Further
VerDate
Dec<
13>
2002
11:
20
Dec
24,
2002
Jkt
200001
PO
00000
Frm
00054
Fmt
4700
Sfmt
4700
E:\
FR\
FM\
26DER1.
SGM
26DER1
| epa | 2024-06-07T20:31:44.053685 | regulations | {
"license": "Public Domain",
"url": "https://downloads.regulations.gov/EPA-HQ-OPP-2002-0277-0001/content.txt"
} |
EPA-HQ-OPP-2002-0278-0001 | Rule | "2002-12-03T05:00:00" | Pesticides; Tolerance Exemptions for Active and Inert Ingredients for Use in Antimicrobial
Formulations (Food-Contact Surface Sanitizing Solutions) | [
Federal
Register:
December
3,
2002
(
Volume
67,
Number
232)]
[
Rules
and
Regulations]
[
Page
71847
71861]
From
the
Federal
Register
Online
via
GPO
Access
[
wais.
access.
gpo.
gov]
[
DOCID:
fr03de02
20]
ENVIRONMENTAL
PROTECTION
AGENCY
40
CFR
Part
180
[
OPP
2002
0278;
FRL
6824
2]
Pesticides;
Tolerance
Exemptions
for
Active
and
Inert
Ingredients
for
Use
in
Antimicrobial
Formulations
(
Food
Contact
Surface
Sanitizing
Solutions)
AGENCY:
Environmental
Protection
Agency
(
EPA).
ACTION:
Direct
final
rule.
SUMMARY:
EPA
is
taking
direct
final
action
to
add
a
new
section
to
part
180
which
lists
the
pesticide
chemicals
that
are
exempt
from
the
requirement
of
a
tolerance
when
used
in
food
contact
surface
sanitizing
solutions.
The
initial
list
of
exempt
pesticide
chemicals
in
the
new
section
is
duplicated
from
the
Food
and
Drug
Administration's
(
FDA)
regulations
in
21
CFR
178.1010.
EPA
is
also
changing
FDA's
naming
[[
Page
71848]]
conventions
for
some
of
the
chemical
substances
that
were
duplicated.
Until
recently,
FDA
under
the
Federal
Food,
Drug,
and
Cosmetic
Act
(
FFDCA)
section
409,
regulated
food
contact
surface
sanitizing
solutions.
With
the
amendments
to
FFDCA
by
the
Food
Quality
Protection
Act
(
FQPA)
of
1996
and
by
the
Antimicrobial
Regulation
Technical
Corrections
Act
(
ARTCA)
of
1998,
these
responsibilities
have
been
restructured.
Under
FFDCA
section
408,
EPA
will
now
regulate
the
pesticide
uses
of
these
chemical
substances
and
FDA
under
FFDCA
section
409
will
continue
to
regulate
any
indirect
food
additive
uses
of
these
chemical
substances.
Registrants
of
existing
food
contact
surface
sanitizing
solutions
that
contain
chemical
substances
other
than
those
listed
in
this
direct
final
rule
should
identify
these
chemical
substances
and
support
their
claim
that
the
chemical
substance
is
generally
recognized
as
safe
(
GRAS),
or
permitted
by
FDA
prior
sanction,
or
approval,
or
subject
to
a
letter
of
no
objection
in
order
to
remain
exempt
from
the
requirement
of
a
FFDCA
section
408
tolerance.
DATES:
This
direct
final
rule
is
effective
on
April
2,
2003
without
further
notice,
unless
EPA
receives
a
relevant
adverse
comment
by
February
3,
2003.
If,
however,
EPA
receives
a
relevant
adverse
comment
during
the
comment
period,
then
EPA
will
publish
a
timely
withdrawal
in
the
Federal
Register
informing
the
public
that
the
direct
final
rule
will
not
take
effect.
We
will
also
publish
a
notice
of
proposed
rulemaking
in
a
future
issue
of
the
Federal
Register.
We
will
address
the
comments
on
the
direct
final
rule
as
part
of
that
notice
of
proposed
rulemaking.
Registrants
should
submit
chemical
substances
not
listed
in
this
document
and
support
their
claims
of
GRAS,
or
prior
sanction,
or
approval,
or
no
objection
of
these
chemical
substances
on
or
before
June
2,
2003.
ADDRESSES:
Comments
may
be
submitted
electronically,
by
mail,
or
through
hand
delivery/
courier.
Follow
the
detailed
instructions
as
provided
in
Unit
I.
of
the
SUPPLEMENTARY
INFORMATION.
Registrants
identifying
chemical
substances
not
listed
in
this
document
and
the
supporting
documentation
for
their
claims
of
GRAS,
or
prior
sanction,
or
approval,
or
no
objection
of
these
chemical
substances
for
inclusion
in
40
CFR
180.940
should
submit
the
information
directly
to
the
person
listed
under
FOR
FURTHER
INFORMATION.
Identification
of
a
chemical
substance
is
not
a
comment
and
should
be
identified
as
``
Submission
of
Non
designated
Prior
Approved
Chemical
Substance.''
FOR
FURTHER
INFORMATION
CONTACT:
Kathryn
Boyle,
Registration
Division
(
7505C),
Office
of
Pesticide
Programs,
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460
0001;
telephone
number:
(
703)
305
6304;
fax
number:
(
703)
305
0599;
e
mail
address:
boyle.
kathryn@
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
a
food
manufacturer,
or
antimicrobial
pesticide
manufacturer.
Potentially
affected
categories
and
entities
may
include,
but
are
not
limited
to:
Examples
of
Categories
NAICS
codes
potentially
affected
entities
Industry
311
Food
manufacturing
Producers
32561
Antimicrobial
pesticides
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
0278.
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.
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.
Certain
types
of
information
will
not
be
placed
in
the
EPA
Dockets.
Information
claimed
as
CBI
and
other
information
whose
disclosure
is
restricted
by
statute,
which
is
not
included
in
the
official
public
docket,
will
not
be
available
for
public
viewing
in
EPA's
electronic
public
docket.
EPA's
policy
is
that
copyrighted
material
will
not
be
placed
in
EPA's
electronic
public
docket
but
will
be
available
only
in
printed,
paper
form
in
the
official
public
docket.
To
the
extent
feasible,
publicly
available
docket
materials
will
be
made
available
in
EPA's
electronic
public
docket.
When
a
document
is
selected
from
the
index
list
in
EPA
Dockets,
the
system
will
identify
whether
the
document
is
available
for
viewing
in
EPA's
electronic
public
docket.
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.
EPA
intends
to
work
towards
providing
electronic
access
to
all
of
the
publicly
[[
Page
71849]]
available
docket
materials
through
EPA's
electronic
public
docket.
For
public
commenters,
it
is
important
to
note
that
EPA's
policy
is
that
public
comments,
whether
submitted
electronically
or
in
paper,
will
be
made
available
for
public
viewing
in
EPA's
electronic
public
docket
as
EPA
receives
them
and
without
change,
unless
the
comment
contains
copyrighted
material,
CBI,
or
other
information
whose
disclosure
is
restricted
by
statute.
When
EPA
identifies
a
comment
containing
copyrighted
material,
EPA
will
provide
a
reference
to
that
material
in
the
version
of
the
comment
that
is
placed
in
EPA's
electronic
public
docket.
The
entire
printed
comment,
including
the
copyrighted
material,
will
be
available
in
the
public
docket.
Public
comments
submitted
on
computer
disks
that
are
mailed
or
delivered
to
the
docket
will
be
transferred
to
EPA's
electronic
public
docket.
Public
comments
that
are
mailed
or
delivered
to
the
docket
will
be
scanned
and
placed
in
EPA's
electronic
public
docket.
Where
practical,
physical
objects
will
be
photographed,
and
the
photograph
will
be
placed
in
EPA's
electronic
public
docket
along
with
a
brief
description
written
by
the
docket
staff.
C.
How
and
To
Whom
Do
I
Submit
Comments?
You
may
submit
comments
electronically,
by
mail,
or
through
hand
delivery/
courier.
To
ensure
proper
receipt
by
EPA,
identify
the
appropriate
docket
ID
number
in
the
subject
line
on
the
first
page
of
your
comment.
Please
ensure
that
your
comments
are
submitted
within
the
specified
comment
period.
Comments
received
after
the
close
of
the
comment
period
will
be
marked
``
late.''
EPA
is
not
required
to
consider
these
late
comments.
If
you
wish
to
submit
CBI
or
information
that
is
otherwise
protected
by
statute,
please
follow
the
instructions
in
Unit
I.
D.
Do
not
use
EPA
Dockets
or
e
mail
to
submit
CBI
or
information
protected
by
statute.
1.
Electronically.
If
you
submit
an
electronic
comment
as
prescribed
in
this
unit,
EPA
recommends
that
you
include
your
name,
mailing
address,
and
an
e
mail
address
or
other
contact
information
in
the
body
of
your
comment.
Also
include
this
contact
information
on
the
outside
of
any
disk
or
CD
ROM
you
submit,
and
in
any
cover
letter
accompanying
the
disk
or
CD
ROM.
This
ensures
that
you
can
be
identified
as
the
submitter
of
the
comment
and
allows
EPA
to
contact
you
in
case
EPA
cannot
read
your
comment
due
to
technical
difficulties
or
needs
further
information
on
the
substance
of
your
comment.
EPA's
policy
is
that
EPA
will
not
edit
your
comment,
and
any
identifying
or
contact
information
provided
in
the
body
of
a
comment
will
be
included
as
part
of
the
comment
that
is
placed
in
the
official
public
docket,
and
made
available
in
EPA's
electronic
public
docket.
If
EPA
cannot
read
your
comment
due
to
technical
difficulties
and
cannot
contact
you
for
clarification,
EPA
may
not
be
able
to
consider
your
comment.
i.
EPA
Dockets.
Your
use
of
EPA's
electronic
public
docket
to
submit
comments
to
EPA
electronically
is
EPA's
preferred
method
for
receiving
comments.
Go
directly
to
EPA
Dockets
at
http://
www.
epa.
gov/
edocket
,
and
follow
the
online
instructions
for
submitting
comments.
Once
in
the
system,
select
``
search,''
and
then
key
in
docket
ID
number
OPP
2002
0278.
The
system
is
an
``
anonymous
access''
system,
which
means
EPA
will
not
know
your
identity,
e
mail
address,
or
other
contact
information
unless
you
provide
it
in
the
body
of
your
comment.
ii.
E
mail.
Comments
may
be
sent
by
e
mail
to
opp
docket@
epa.
gov,
Attention:
Docket
ID
Number
OPP
2002
0278.
In
contrast
to
EPA's
electronic
public
docket,
EPA's
e
mail
system
is
not
an
``
anonymous
access''
system.
If
you
send
an
e
mail
comment
directly
to
the
docket
without
going
through
EPA's
electronic
public
docket,
EPA's
e
mail
system
automatically
captures
your
e
mail
address.
E
mail
addresses
that
are
automatically
captured
by
EPA's
e
mail
system
are
included
as
part
of
the
comment
that
is
placed
in
the
official
public
docket,
and
made
available
in
EPA's
electronic
public
docket.
iii.
Disk
or
CD
ROM.
You
may
submit
comments
on
a
disk
or
CD
ROM
that
you
mail
to
the
mailing
address
identified
in
Unit
I.
C.
2.
These
electronic
submissions
will
be
accepted
in
WordPerfect
or
ASCII
file
format.
Avoid
the
use
of
special
characters
and
any
form
of
encryption.
2.
By
mail.
Send
your
comments
to:
Public
Information
and
Records
Integrity
Branch
(
PIRIB)
(
7502C),
Office
of
Pesticide
Programs
(
OPP),
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460
0001,
Attention:
Docket
ID
Number
OPP
2002
0278.
3.
By
hand
delivery
or
courier.
Deliver
your
comments
to:
Public
Information
and
Records
Integrity
Branch
(
PIRIB),
Office
of
Pesticide
Programs
(
OPP),
Environmental
Protection
Agency,
Rm.
119,
Crystal
Mall
2,
1921
Jefferson
Davis
Hwy.,
Arlington,
VA,
Attention:
Docket
ID
Number
OPP
2002
0278.
Such
deliveries
are
only
accepted
during
the
docket's
normal
hours
of
operation
as
identified
in
Unit
I.
B.
1.
D.
How
Should
I
Submit
CBI
to
the
Agency?
Do
not
submit
information
that
you
consider
to
be
CBI
electronically
through
EPA's
electronic
public
docket
or
by
e
mail.
You
may
claim
information
that
you
submit
to
EPA
as
CBI
by
marking
any
part
or
all
of
that
information
as
CBI
(
if
you
submit
CBI
on
disk
or
CD
ROM,
mark
the
outside
of
the
disk
or
CD
ROM
as
CBI
and
then
identify
electronically
within
the
disk
or
CD
ROM
the
specific
information
that
is
CBI).
Information
so
marked
will
not
be
disclosed
except
in
accordance
with
procedures
set
forth
in
40
CFR
part
2.
In
addition
to
one
complete
version
of
the
comment
that
includes
any
information
claimed
as
CBI,
a
copy
of
the
comment
that
does
not
contain
the
information
claimed
as
CBI
must
be
submitted
for
inclusion
in
the
public
docket
and
EPA's
electronic
public
docket.
If
you
submit
the
copy
that
does
not
contain
CBI
on
disk
or
CD
ROM,
mark
the
outside
of
the
disk
or
CD
ROM
clearly
that
it
does
not
contain
CBI.
Information
not
marked
as
CBI
will
be
included
in
the
public
docket
and
EPA's
electronic
public
docket
without
prior
notice.
If
you
have
any
questions
about
CBI
or
the
procedures
for
claiming
CBI,
please
consult
the
person
listed
under
FOR
FURTHER
INFORMATION
CONTACT.
E.
What
Should
I
Consider
as
I
Prepare
My
Comments
for
EPA?
You
may
find
the
following
suggestions
helpful
for
preparing
your
comments:
1.
Explain
your
views
as
clearly
as
possible.
2.
Describe
any
assumptions
that
you
used.
3.
Provide
copies
of
any
technical
information
and/
or
data
you
used
that
support
your
views.
4.
If
you
estimate
potential
burden
or
costs,
explain
how
you
arrived
at
the
estimate
that
you
provide.
5.
Provide
specific
examples
to
illustrate
your
concerns.
6.
Offer
alternative
ways
to
improve
the
rule
or
collection
activity.
7.
Make
sure
to
submit
your
comments
by
the
deadline
in
this
document.
8.
To
ensure
proper
receipt
by
EPA,
be
sure
to
identify
the
docket
ID
number
assigned
to
this
action
in
the
subject
line
on
the
first
page
of
your
response.
You
may
also
provide
the
name,
date,
and
Federal
Register
citation.
[[
Page
71850]]
II.
Authority
A.
What
is
the
Agency's
Authority
for
Taking
this
Action?
This
direct
final
rule
is
issued
under
FFDCA
section
408,
21
U.
S.
C.
346a,
as
amended
by
FQPA
(
Public
Law
104
170),
and
ARTCA
(
Public
Law
105
324).
Section
408
of
FFDCA
authorizes
the
establishment
of
tolerances,
exemptions
from
the
requirement
of
a
tolerance,
modifications
in
tolerances,
and
revocation
of
tolerances
for
residues
of
pesticide
chemicals
in
or
on
raw
agricultural
commodities
and
processed
foods.
Section
408(
j)(
2)
of
FFDCA
provides
that
all
regulations
issued
by
FDA
under
FFDCA
section
409
that
stated
conditions
for
safe
use
of
substances
that
are
now,
post
FQPA,
considered
pesticide
chemical
residues
in
or
on
processed
food
or
that
otherwise
stated
the
conditions
under
which
such
pesticide
chemicals
could
be
safely
used,
shall
be
deemed
to
be
regulations
issued
under
FFDCA
section
408.
Due
to
the
FQPA
and
ARTCA
amedments
to
FFDCA,
those
chemical
substances
originally
regulated
by
FDA
under
FFDCA
section
409
as
foodcontact
surface
sanitizing
solutions
are
now
the
responsibility
of
EPA.
These
pesticide
chemicals
are
now
subject
to
modification
or
revocation
at
EPA's
initiative
under
FFDCA
section
408(
e).
This
direct
final
rule
duplicates
those
chemical
substances
found
in
21
CFR
178.1010
which
are
now
pesticide
tolerance
exemptions
to
40
CFR
180.940.
EPA's
rulemaking
activity
will
have
no
effect
on
any
of
the
FDA
regulated
FFDCA
section
409
food
additive
regulations
in
21
CFR
178.1010.
B.
Why
is
EPA
Issuing
this
as
a
Direct
Final
Rule?
EPA
is
issuing
this
action
as
a
direct
final
rule
without
prior
proposal
because
the
Agency
believes
that
this
action
is
not
controversial
and
is
not
likely
to
result
in
any
adverse
comments,
inasmuch
as
this
action
simply
implements
amendments
to
the
statutory
authority
and
reflects
the
statutory
transfer
of
jurisdiction
from
FDA
to
EPA.
Its
primary
effect
is
to
substitute
EPA's
regulatory
procedures
for
those
of
FDA
in
approving
food
contact
surface
sanitizing
solutions
under
FFDCA.
The
chemical
substances
were
subject
to
FDA
review
under
FFDCA
section
409
and
have
food
additive
clearances
codified
at
21
CFR
178.1010.
This
direct
final
rule
duplicates
the
conditions
for
use
of
certain
pesticide
chemical
residues
that
are
currently
listed
in
21
CFR
178.1010
to
40
CFR
180.940.
In
addition,
this
direct
final
rule
changes
the
process
by
which
pesticide
registrants
obtain
approval
of
food
contact
surface
sanitizing
solutions
as
well
as
how
those
approvals
are
expressed
in
the
CFR.
However,
it
does
not
alter
the
quantity
or
nature
of
residues
of
these
food
contact
surface
sanitizing
solutions
that
might
lawfully
be
present
in
food.
The
Agency
believes
that
it
is
important
to
make
this
action
effective
as
soon
as
possible,
in
order
to
clarify
the
jurisdiction
between
EPA
and
FDA
over
these
chemical
substances.
This
direct
final
rule
is
effective
on
April
2,
2003
without
further
notice,
unless
EPA
receives
a
relevant
adverse
comment
by
February
3,
2003.
If,
however,
EPA
receives
a
relevant
adverse
comment
during
the
comment
period,
then
EPA
will
publish
a
timely
withdrawal
in
the
Federal
Register
informing
the
public
that
the
direct
final
rule
will
not
take
effect.
We
will
also
publish
a
notice
of
proposed
rulemaking
in
a
future
issue
of
the
Federal
Register.
We
will
address
the
comments
on
the
direct
final
rule
as
part
of
that
notice
of
proposed
rulemaking.
III.
Summary
of
this
Action
A.
Why
is
There
an
Overlap
of
EPA's
and
FDA's
Regulatory
Authorities?
Since
EPA
was
created
in
1970,
EPA
and
FDA
have
shared
authority
under
FFDCA
over
pesticide
chemical
residues
in
food.
Enactment
of
FQPA
in
1996
amended
FFDCA,
and
shifted
to
EPA
regulatory
authority
over
certain
pesticide
residues
which
were
previously
subject
to
FDA
authority.
Prior
to
1996,
products
used
to
sanitize
or
disinfect
permanent
or
semi
permanent
food
contact
surfaces
were
regulated
by
FDA
as
indirect
food
additives
under
FFDCA
section
409.
Under
the
FQPA
and
ARTCA
amendments
to
FFDCA,
antimicrobial
formulations
used
on
permanent
or
semi
permanent
food
contact
surfaces
other
than
food
packaging
are
now
considered
``
pesticide
chemicals''
and
are
regulated
by
EPA
under
FFDCA
section
408.
FQPA
added
a
provision
to
FFDCA
to
assure
an
orderly
transition
to
the
new
regulatory
system.
Section
408(
j)(
2)
of
FFDCA
provides
that
all
food
additive
regulations
issued
under
FFDCA
section
409
prior
to
the
enactment
of
FQPA
for
antimicrobial
uses
that
became
pesticide
chemical
uses
subsequent
to
FQPA
and
that
were
not
affected
by
ARTCA
shall
be
deemed
to
be
regulations
issued
under
FFDCA
section
408.
Thus,
FQPA
converted
existing
food
additive
regulations
issued
by
FDA
under
FFDCA
section
409,
for
chemical
substances
that
post
FQPA
became
pesticide
chemicals,
into
FFDCA
section
408
pesticide
chemical
tolerances
or
tolerance
exemptions.
This
``
grandfather''
provision
of
FFDCA
section
408(
j)
assures
that
pesticide
chemical
residues
conforming
to
regulations
issued
under
the
authority
of
FFDCA
section
409
will
not
render
food
adulterated
as
a
result
of
the
jurisdictional
shift
from
FDA
to
EPA.
In
1998,
ARTCA
amended
the
definition
of
``
pesticide
chemical''
in
FFDCA
section
201(
q)
so
as
to
exclude
certain
antimicrobial
pesticide
residues
from
the
authority
of
FFDCA
section
408.
Consistent
with
FFDCA
section
408(
j)(
4),
these
residues
now
fall
within
the
authority
of
FFDCA
section
409.
As
a
result,
certain
uses
of
food
contact
surface
sanitizing
solutions
identified
in
FDA's
regulations
at
21
CFR
178.1010
remain
subject
to
FFDCA
section
409
regulations
just
as
they
did
pre
FQPA,
while
other
uses
are
now
subject
to
EPA's
jurisdiction
under
FFDCA
section
408.
B.
Why
are
These
Tolerance
Exemptions
not
Subject
to
Tolerance
Reassessment
at
this
Time?
Under
FFDCA
section
408(
q),
EPA
is
required
to
reassess
all
tolerance
exemptions
that
were
in
effect
on
the
day
before
the
enactment
of
the
FQPA.
The
tolerance
exemptions
for
inert
ingredients
as
well
as
those
active
ingredients
not
yet
completed
will
be
reassessed
in
accordance
with
EPA's
schedule
for
tolerance
reassessment
published
in
the
Federal
Register
of
August
4,
1997
(
62
FR
42019)
(
FRL
5734
6).
The
tolerance
exemptions
in
this
direct
final
rule
codified
in
40
CFR
180.940
already
exist
as
valid
FFDCA
section
408
regulations.
FDA
promulgated
the
food
additive
regulations
in
21
CFR
178.1010
under
the
authority
of
FFDCA
section
409
prior
to
the
enactment
of
FQPA.
By
operation
of
FFDCA
section
408(
j)(
2),
those
portions
of
21
CFR
178.1010
that
pertain
to
chemical
substances
that
are
pesticide
chemicals
post
FQPA
and
remain
as
such
post
ARTCA
were
converted
to
FFDCA
section
408
tolerance
exemptions.
EPA's
duplication
of
these
tolerance
exemptions
is
not
``
establishing,
modifying,
or
revoking
a
tolerance''
under
FFDCA
section
408(
b).
EPA
is,
therefore,
not
required
to
conduct
a
full
reassessment
of
these
tolerance
exemptions
at
this
time.
[[
Page
71851]]
C.
Why
is
40
CFR
180.940
Being
Created?
The
Agency
is
duplicating
in
40
CFR
180.940
only
those
portions
of
the
regulations
in
21
CFR
178.1010
that
pertain
to
pesticide
chemicals.
This
duplication
will
have
no
effect
on
any
of
FDA's
regulated
FFDCA
section
409
food
additive
regulations
in
21
CFR
178.1010.
In
establishing
food
additive
regulations
for
food
contact
surface
sanitizing
solutions
in
21
CFR
178.1010,
FDA
used
a
formulationspecific
approach.
Consistent
with
its
authority
under
FFDCA
section
409,
FDA
issued
regulations
prescribing
the
conditions
under
which
food
contact
surface
sanitizing
solutions
might
be
safely
used.
FDA
approved
the
use
of
each
food
contact
surface
sanitizing
solution
formulation
as
a
whole,
rather
than
regulating
each
component
chemical
substance
individually.
In
addition,
FDA
included
a
generic
exemption
for
any
chemical
substance
considered
to
be
GRAS,
and
in
some
cases,
issued
letters
not
objecting
to
certain
additional
chemical
substances
in
the
formulations.
By
contrast,
FFDCA
section
408
authorizes
EPA
to
issue
regulations
establishing
tolerances
or
exemptions
from
the
requirement
of
a
tolerance.
EPA's
practice
has
been
to
issue
these
regulations
on
a
chemical
specific
basis,
whereby
each
ingredient
in
the
product
is
the
subject
of
a
separate
tolerance
or
exemption
regulation.
Food
contact
surface
sanitizing
solutions
meet
the
requirements
of
FFDCA
if
each
ingredient
has
an
appropriate
clearance
under
FFDCA,
either
a
tolerance
or
an
exemption
from
the
requirement
of
a
tolerance,
and
any
conditions
on
the
clearance
are
observed.
Translating
the
regulatory
decisions
made
by
FDA
into
a
comparable
EPA
scheme
requires
considerably
greater
work
on
EPA's
part
than
merely
copying
those
portions
of
the
existing
regulations
in
21
CFR
178.1010
that
pertain
to
pesticide
chemicals
directly
into
40
CFR
180.940.
EPA
must
disaggregate
the
formulations
in
21
CFR
178.1010
that
pertain
to
pesticide
chemicals
into
their
component
ingredients.
EPA
must
also
provide
a
mechanism
to
address
those
ingredients
not
identified
by
name
in
21
CFR
178.1010
but
that
were,
for
example,
permitted
by
prior
sanction
or
approval,
not
objected
to,
or
generally
recognized
as
safe.
This,
in
fact,
places
a
higher
initial
demand
on
EPA
resources
than
would
be
required
to
simply
copy
FDA's
approach.
However,
EPA
is
convinced
that
the
long
term
administrative
convenience
of
using
a
consistent
regulatory
scheme
for
all
pesticide
chemicals
subject
to
FFDCA
section
408
outweighs
the
initial
burdens.
FDA's
formulation
specific
approach
is
different
from
EPA's
chemical
specific
approach.
Under
EPA's
approach,
a
tolerance
exemption
would
be
approved
once
for
each
particular
pesticide
chemical,
and
would
not
need
to
be
repeated
as
new
products
containing
that
chemical
substance
enter
the
market.
EPA's
approval
process
is
not
complex,
will
allow
for
a
wide
variety
of
potential
products,
and
fosters
innovative
formulation
approaches.
In
addition,
by
listing
in
one
place
(
40
CFR
180.940)
all
chemical
substances
exempted
from
the
requirement
of
a
tolerance
when
used
in
food
contact
surface
sanitizing
solutions,
EPA's
approach
will
increase
the
transparency
of
its
regulatory
process.
This
duplication
will
not
allow
any
residues
beyond
those
already
permitted
by
21
CFR
178.1010.
EPA
believes
that
the
chemical
specific
approach
and
FDA's
formulation
specific
approach
are
equivalent
from
a
risk
management
perspective,
inasmuch
as
each
would
result
in
the
same
levels
of
residues
from
these
chemical
substances.
As
part
of
the
duplication,
EPA
changed
the
naming
conventions
(
chemical
nomenclature),
as
well
as
combining,
as
appropriate,
chemical
substances
that
appear
in
21
CFR
178.1010
under
two
or
more
names
under
a
single
name.
The
Agency
has
attempted
to
identify
each
of
the
listed
chemical
substances
using
the
Chemical
Abstracts
Service
Registry
Number
(
CAS
No.).
The
CAS
No.
provides
one
of
the
most
distinct
and
universally
accepted
means
of
identifying
chemical
substances.
Generally,
there
will
be
only
one
CAS
No.
per
listed
chemical
substance;
however,
it
is
possible
that
more
than
one
CAS
No.
may
be
appropriate
for
some
chemical
substances.
The
lack
of
a
CAS
No.
will
not
preclude
EPA
from
including
chemical
substances
in
40
CFR
180.940.
The
lower
concentration
limits
specified
in
21
CFR
178.1010
are
not
included
in
40
CFR
180.940
because
of
the
differences
between
FDA's
approach
and
EPA's
approach.
Although
EPA
establishes
tolerance
exemptions
for
use
in
food
contact
surface
sanitizing
solutions
under
FFDCA,
all
pesticide
products
must
also
meet
the
criteria
for
registration
under
the
Federal
Insecticide,
Fungicide,
and
Rodenticide
Act
(
FIFRA)
before
being
offered
for
sale.
EPA
relies
on
conditions
imposed
through
the
FIFRA
registration
process
to
address
safety
and
for
antimicrobial
formulated
products
efficacy.
Accordingly,
the
lower
limits
on
concentrations
of
pesticide
chemicals,
that
appear
in
21
CFR
178.1010
will
not
appear
in
40
CFR
180.940.
Three
types
of
food
contact
surface
sanitizing
solutions
are
described
in
21
CFR
178.1010:
[
sbull]
Those
used
on
food
contact
surfaces
in
public
eating
places.
[
sbull]
Those
used
on
dairy
processing
equipment.
[
sbull]
Those
used
on
food
processing
equipment
and
utensils.
According
to
FDA,
food
contact
surface
sanitizing
solutions
that
are
acceptable
for
use
on
food
contact
surfaces
in
public
eating
places
can
also
be
used
on
dairy
processing
equipment,
and
on
food
processing
equipment
and
utensils.
Food
contact
surface
sanitizing
solutions
that
are
acceptable
for
use
on
dairy
equipment
can
also
be
used
on
foodprocessing
equipment
and
utensils.
EPA
has
separated
the
component
ingredients
by
both
chemical
and
concentration
for
these
three
types
of
food
contact
surface
sanitizing
solutions,
which
will
be
included
in
40
CFR
180.940.
IV.
Addition
of
Non
Designated
Prior
Approved
Chemical
Substances
21
CFR
178.1010
allows
the
use
of
GRAS
chemical
substances
and
chemical
substances
``
permitted
by
prior
sanction
or
approval,''
that
are
not
expressly
identified.
These
chemical
substances
were
subject
to
the
sanitizer
formulation
approval
under
FDA's
regulation
before
these
uses
became
FFDCA
section
408
tolerance
exemptions
under
FFDCA
section
408(
j)(
2).
Accordingly,
many
food
contact
sanitizing
solutions
that
presently
are
authorized
for
use
under
21
CFR
178.1010
contain
ingredients
which
are
not
identified
in
this
direct
final
rule.
As
discussed
in
this
unit,
EPA
is
asking
registrants
to
identify
these
other
ingredients
that
they
believe
should
be
included
in
40
CFR
180.940.
EPA
intends
to
publish
a
revision
to
40
CFR
180.940
adding
these
chemical
substances.
In
the
interim,
to
preserve
the
use
of
foodcontact
surface
sanitizing
solutions
that
were
cleared
for
use
before
FQPA's
enactment
and
that
contain
chemical
substances
that
are
not
specifically
identified
in
21
CFR
178.1010,
EPA
has
decided
to
honor
those
approvals
under
21
CFR
178.1010
until
EPA
has
received
and
reviewed
registrant's
claims
with
respect
to
unspecified
pesticide
chemicals,
as
discussed
in
this
unit.
FDA's
regulations
(
21
CFR
178.1010(
b))
allowed
the
addition
to
food
contact
surface
sanitizing
solutions
[[
Page
71852]]
of
GRAS
components,
and
components
permitted
by
prior
sanction
or
approval
or
subject
to
a
letter
of
no
objection.
Much
of
this
information
should
be
in
EPA's
files.
The
Agency
will
access
this
information.
However,
EPA
may
not
have
ready
access
to
all
information
on
all
chemicals
in
existing
food
contact
surface
sanitizing
solution
formulations
which
could
meet
these
criteria.
Submission
of
this
information
to
EPA
would
also
reduce
the
possibility
of
an
existing
food
contact
surface
sanitizing
solution
having
a
component
that
lacks
a
tolerance
exemption
under
40
CFR
180.940.
Therefore,
registrants
who
believe
that
components
of
their
food
contact
surface
sanitizing
solutions
are
exempted
under
21
CFR
178.1010(
b)
should
advise
EPA
in
writing
that
these
chemical
substances
(
along
with
the
CAS
No.)
should
be
included
in
40
CFR
180.940.
The
submission
of
this
information
facilitates
EPA's
process
for
adding
these
chemical
substances
cleared
under
21
CFR
178.1010(
b),
but
not
specifically
listed
by
name,
to
40
CFR
180.940.
The
EPA
will
also
need
any
available
information
documenting
the
claim
that
the
component
is
GRAS,
prior
sanctioned
or
approved,
or
subject
to
a
letter
of
no
objection.
Claims
and
supporting
documentation
should
be
sent
directly
to
the
person
listed
under
FOR
FURTHER
INFORMATION
CONTACT.
Claims
are
not
comments
on
this
direct
final
rule
and
should
be
identified
on
the
subject
line
as
``
Submission
of
Non
designated
Prior
Approved
Chemical
Substance.''
If
you
have
any
questions
about
the
many
types
of
information
that
could
be
submitted
please
consult
the
person
listed
under
FOR
FURTHER
INFORMATION
CONTACT.
The
Agency
does
not
anticipate
that
registrants
will
be
required
to
submit
an
excessive
amount
of
information,
and,
in
fact,
believes
that
most
registrants
will
be
able
to
submit
the
necessary
information
with
minimal
effort.
EPA
will
review
and
evaluate
the
information
provided.
Chemical
substances
identified
in
claims
received
not
later
than
June
2,
2003
may
be
eligible
for
inclusion
in
Sec.
180.940
under
FFDCA
section
408(
j)(
2).
EPA
anticipates
publishing
a
notice
of
proposed
rulemaking
identifying
those
chemical
substances
shortly
after
that
date.
V.
Regulatory
Assessment
Requirements
EPA
is
taking
direct
final
action
to
add
a
new
Sec.
180.940
to
40
CFR
part
180,
subpart
D
which
lists
the
pesticide
chemicals
that
are
exempt
from
the
requirement
of
a
tolerance
when
used
in
food
contact
surface
sanitizing
solutions.
The
initial
list
duplicates
pesticide
chemicals
in
40
CFR
180.940
that
are
active
and
inert
ingredients
listed
in
21
CFR
178.1010.
Since
this
direct
final
rule
does
not
impose
any
new
requirements,
it
is
not
subject
to
review
by
the
Office
of
Management
and
Budget
(
OMB)
under
Executive
Order
12866,
entitled
Regulatory
Planning
and
Review
(
58
FR
51735,
October
4,
1993),
Executive
Order
13045,
entitled
Protection
of
Children
from
Environmental
Health
Risks
and
Safety
Risks
(
62
FR
19885,
April
23,
1997),
or
Executive
Order
13211,
entitled
Actions
Concerning
Regulations
That
Significantly
Affect
Energy
Supply,
Distribution,
or
Use
(
66
FR
28355,
May
22,
2001).
This
direct
final
rule
directly
regulates
food
processors,
food
handlers,
and
food
retailers,
but
does
not
affect
States,
local,
or
Tribal
governments
directly.
This
action
does
not
alter
the
relationships
or
distribution
of
power
and
responsibilities
established
by
Congress
in
the
preemption
provisions
of
FFDCA
section
408(
n)(
4).
This
action
does
not
have
substantial
direct
effects
on
State
or
tribal
governments,
on
the
relationship
between
the
Federal
government
and
States
or
Indian
tribes,
or
on
the
distribution
of
power
and
responsibilities
between
the
Federal
government
and
States
or
Indian
tribes.
As
a
result,
this
action
does
not
require
any
action
under
Executive
Order
13132,
entitled
Federalism
(
64
FR
43255,
August
10,
1999),
or
under
Executive
Order
13175,
entitled
Consultation
and
Coordination
with
Indian
Tribal
Governments
(
65
FR
67249,
November
6,
2000).
Nor
does
it
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
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
Executive
Order
12630,
entitled
Governmental
Actions
and
Interference
with
Constitutionally
Protected
Property
Rights
(
53
FR
8859,
March
15,
1988).
This
action
does
not
involve
any
technical
standards
that
would
require
Agency
consideration
of
voluntary
consensus
standards
under
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).
Under
section
605(
b)
of
the
Regulatory
Flexibility
Act
(
RFA)
(
5
U.
S.
C.
601
et
seq.),
the
Agency
hereby
certifies
that
the
creation
of
a
new
Sec.
180.940
does
not
have
significant
negative
economic
impact
on
a
substantial
number
of
small
entities.
The
rationale
supporting
this
conclusion
is
as
follows.
This
direct
final
rule
does
not
impose
any
requirements,
it
establishes
exemptions
from
the
requirement
for
a
tolerance.
The
Agency
is,
however,
also
commencing
a
process
whereby
EPA
will
require
certain
persons
to
identify
chemical
substances
considered
to
be
GRAS
(
which
could
include
self
affirmed
GRAS
chemicals),
or
permitted
by
prior
sanction
or
approval
in
existing
food
contact
surface
sanitizing
solutions.
The
information
available
to
the
Agency
indicates
that
fewer
than
500
companies
have
approximately
1,300
products
that
could
fall
under
this
category.
EPA
anticipates
the
economic
burden
on
small
entities
to
be
minor,
since
the
Agency
is
only
asking
for
confirmation
that
the
chemical
substances
considered
to
be
GRAS
or
permitted
by
prior
sanction
or
approval
in
existing
foodcontact
surface
sanitizing
solutions
are
in
fact
part
of
an
existing
formulation,
and
information
as
to
why
the
chemical
is
considered
to
be
GRAS,
or
a
copy
of
an
FDA
letter
not
objecting
to
the
use
of
a
chemical
substance.
By
contrast,
this
direct
final
rule
is
beneficial
to
the
regulated
community
by
increasing
the
number
of
inert
ingredients
for
use
in
antimicrobial
formulations
and
by
reducing
the
regulatory
burden
on
persons
seeking
to
market
new
combinations
of
ingredients
for
certain
hard
surface
sanitizing
solutions.
Additionally,
this
direct
final
rule
provides
a
more
transparent
listing
of
pesticide
chemicals
used
in
food
contact
surface
sanitizing
solutions
to
the
public.
According
to
the
Paperwork
Reduction
Act
(
PRA),
44
U.
S.
C.
3501
et
seq.,
an
Agency
may
not
conduct
or
sponsor,
and
a
person
is
not
required
to
respond
to
a
collection
of
information
that
requires
OMB
approval
under
the
PRA,
unless
it
has
been
approved
by
OMB
and
displays
a
currently
valid
OMB
control
number.
The
OMB
control
numbers
for
EPA's
regulations,
after
initial
display
in
the
preamble
of
the
final
rule
and
in
addition
to
its
display
on
any
related
collection
instrument,
are
listed
in
40
CFR
part
9.
This
direct
final
rule
does
not
impose
any
new
information
collection
requirements
that
would
require
separate
approval
by
OMB
under
the
PRA.
Under
5
CFR
1320.3(
h),
the
request
for
information
discussed
in
[[
Page
71853]]
Unit
VII.
is
not
subject
to
approval
under
the
PRA,
and
the
information
collection
activities
related
to
the
Agency's
tolerance
exemption
process
have
already
been
approved
by
OMB
under
OMB
control
numbers
2070
0024
(
EPA
ICR
No.
597).
The
annual
``
respondent''
(
petitioner)
burden
for
the
pesticide
tolerance
petitions
program
is
estimated
to
average
1,726
hours
per
petition.
According
to
the
PRA,
``
burden''
means
the
total
time,
effort,
or
financial
resources
expended
by
persons
to
generate,
maintain,
retain,
or
disclose
or
provide
information
to
or
for
a
Federal
agency.
For
this
collection,
it
is
the
time
reading
the
regulations;
planning
the
necessary
data
collection
activities;
conducting
tests;
analyzing
data;
generating
reports
and
completing
other
required
paperwork;
and
storing,
filing,
and
maintaining
the
data.
Send
comments
regarding
this
burden
estimate
or
any
other
aspect
of
the
collection
activity,
including
suggestions
for
reducing
the
burden
to:
Director,
Collection
Strategies
Division,
Environmental
Protection
Agency
(
2822),
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460.
Include
the
OMB
control
number
2070
0024
in
any
correspondence
about
this
collection
activity,
but
do
not
submit
the
requested
information
or
forms
to
this
address.
VI.
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,
Pesticides
and
pests,
Reporting
and
recordkeeping
requirements.
Dated:
November
22,
2002.
James
Jones,
Acting
Director,
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),
346a
and
371.
2.
A
new
Sec.
180.940
is
added
to
subpart
D
of
part
180
to
read
as
follows.
Sec.
180.940
Food
contact
surface
sanitizing
solutions;
exemptions
from
the
requirement
of
a
tolerance.
Residues
of
the
following
chemical
substances
are
exempted
from
the
requirement
of
a
tolerance
when
used
in
accordance
with
good
manufacturing
practice
as
ingredients
in
an
antimicrobial
pesticide
formulation,
provided
that
the
chemical
substance
is
applied
on
a
semipermanent
or
permanent
food
contact
surface
(
other
than
being
applied
on
food
packaging)
with
adequate
draining
before
contact
with
food.
(
a)
The
following
chemical
substances
when
used
as
ingredients
in
an
antimicrobial
pesticide
formulation
may
be
applied
to:
Food
contact
surfaces
in
public
eating
places,
dairy
processing
equipment,
and
foodprocessing
equipment
and
utensils.
Pesticide
chemical
CAS
No.
Limits
Acetic
acid
64
19
7
When
ready
for
use,
the
end
use
concentration
is
not
to
exceed
290
parts
per
million
(
ppm)
[
alpha]
Alkyl(
C10
C14)[
<]
hydroxypoly(
oxyethylene)
poly
(
oxypropylene)
average
molecular
weight
(
in
amu),
768
to
837
[
alpha]
Alkyl(
C12
C18)[
<]
hydroxypoly(
oxyethylene)
poly(
oxypropylene)
average
molecular
weight
(
in
amu),
950
to
1,120
Ammonium
chloride
12125
02
9
When
ready
for
use,
the
end
use
concentration
is
not
to
exceed
48
ppm
D&
C
Blue
No.
1
(
methylene
blue)
61
73
4
When
ready
for
use,
the
end
use
concentration
is
not
to
exceed
0.4
ppm
Dextrin
9004
53
9
When
ready
for
use,
the
end
use
concentration
is
not
to
exceed
16
ppm
Ethanol
64
17
5
None
Ethylenediaminetetraacetic
64
02
8
None
acid
(
EDTA),
tetrasodium
salt
Hydrogen
peroxide
7722
84
1
When
ready
for
use,
the
end
use
concentration
is
not
to
exceed
91
ppm
Hypochlorous
acid,
sodium
salt
7681
52
9
When
ready
for
use,
the
end
use
concentration
is
not
to
exceed
200
ppm
determined
as
total
available
chlorine
Iodine
7553
56
2
When
ready
for
use,
the
end
use
concentration
is
not
to
exceed
25
ppm
of
titratable
iodine
Magnesium
oxide
1309
48
4
None
[[
Page
71854]]
[
alpha](
p
Nonylphenyl)
None
None
[<
g]
hydroxypoly(
oxyethylene)
average
poly(
oxyethylene)
content
11
moles)
Octadecanoic
acid,
calcium
1592
23
0
When
ready
for
use,
salt
the
end
use
concentration
is
not
to
exceed
16
ppm
1
Octanesulfonic
acid,
sodium
5324
84
5
When
ready
for
use,
salt
the
end
use
concentration
is
not
to
exceed
46
ppm
of
total
active
fatty
acids
Octanoic
acid
124
07
2
When
ready
for
use,
the
end
use
concentration
is
not
to
exceed
52
ppm
of
total
active
fatty
acids
Oxirane,
methyl,
polymer
with
9003
11
6
None
oxirane,
minimum
molecular
weight
(
in
amu),
1,900
Peroxyacetic
acid
79
21
0
When
ready
for
use,
the
end
use
concentration
is
not
to
exceed
58
ppm
Peroxyoctanoic
acid
33734
57
5
When
ready
for
use,
the
end
use
concentration
is
not
to
exceed
52
ppm
Phosphonic
acid,
(
1
2809
21
4
When
ready
for
use,
hydroxyethylidene)
bis
the
end
use
concentration
is
not
to
exceed
14
ppm
Phosphoric
acid,
trisodium
7601
54
9
When
ready
for
use,
salt
the
end
use
concentration
is
not
to
exceed
5,916
ppm
Potassium
bromide
7758
02
3
When
ready
for
use,
the
end
use
concentration
is
not
to
exceed
46
ppm
total
available
halogen
Potassium
iodide
7681
11
0
When
ready
for
use,
the
end
use
concentration
is
not
to
exceed
25
ppm
of
titratable
iodine
Potassium
permanganate
7722
64
7
When
ready
for
use,
the
end
use
concentration
is
not
to
exceed
0.7
ppm
2
Propanol
(
isopropanol)
67
63
0
None
Quaternary
ammonium
compounds,
None
When
ready
for
use,
alkyl
(
C12
C16)
the
end
use
benzyldimethyl,
chlorides,
concentration
is
not
average
molecular
weight
(
in
to
exceed
150
ppm
of
amu),
351
to
380
active
quaternary
compound
Quaternary
ammonium
compounds,
None
When
ready
for
use,
alkyl
(
C12
C18)
the
end
use
benzyldimethyl,
chlorides
concentration
is
not
to
exceed
200
ppm
of
active
quaternary
compound
in
the
formulated
product
Quaternary
ammonium
compounds,
None
When
ready
for
use,
n
alkyl
(
C12
C14)
dimethyl
the
end
use
ethylbenzyl
ammonium
concentration
is
not
chloride,
average
molecular
to
exceed
200
ppm
of
weight
(
in
amu),
377
to
384
active
quaternary
compound
Quaternary
ammonium
compounds
None
When
ready
for
use,
n
alkyl
(
C12
C18)
dimethyl
the
end
use
ethylbenzyl
ammonium
chloride
concentration
is
not
average
molecular
weight
(
in
to
exceed
200
ppm
of
amu),
384
active
quaternary
compound
Quaternary
ammonium
compounds
None
When
ready
for
use,
di
n
alkyl
(
C8
C10)
dimethyl
the
end
use
ammonium
chloride,
average
concentration
is
not
molecular
weight
(
in
amu),
to
exceed
150
ppm
of
332
to
361
active
quaternary
compound
Sodium
bicarbonate
144
55
8
When
ready
for
use,
the
end
use
concentration
is
not
to
exceed
120
ppm
Starch
9005
25
8
When
ready
for
use,
the
end
use
concentration
is
not
to
exceed
16
ppm
Sulfuric
acid
monododecyl
151
21
3
When
ready
for
use,
ester,
sodium
salt
(
sodium
the
end
use
lauryl
sulfate)
concentration
is
not
to
exceed
3
ppm
1,3,5
Triazine
2,4,6(
1H,
3H,
5H)
2893
78
9
When
ready
for
use,
trione,
1,3
dichloro,
sodium
the
end
use
salt
concentration
is
not
to
exceed
100
ppm
determined
as
total
available
chlorine
(
b)
The
following
chemical
substances
when
used
as
ingredients
in
an
antimicrobial
pesticide
formulation
may
be
applied
to:
Dairyprocessing
equipment,
and
food
processing
equipment
and
utensils.
[[
Page
71855]]
Pesticide
chemical
CAS
No.
Limits
Acetic
acid
64
19
7
When
ready
for
use,
the
end
use
concentration
is
not
to
exceed
686
ppm
Acetic
acid,
chloro,
sodium
68608
66
2
When
ready
for
use,
salt,
reaction
products
with
the
end
use
4,5
dihydro
2
undecyl
1H
concentration
is
not
imidazole
1
ethanol
and
to
exceed
42
ppm
sodium
hydroxide
chloroacetic
acid
Benzenesulfonic
acid,
dodecyl
27176
87
0
When
ready
for
use,
the
end
use
concentration
is
not
to
exceed
5.5
ppm
Butanedioic
acid,
octenyl
28805
58
5
When
ready
for
use,
the
end
use
concentration
is
not
to
exceed
156
ppm
Butoxy
monoether
of
mixed
None
None
(
ethylene
propylene)
polyalkylene
glycol,
minimum
average
molecular
weight
(
in
amu),
2400
Calcium
chloride
10043
52
4
When
ready
for
use,
the
end
use
concentration
is
not
to
exceed
17
ppm
n
Carboxylic
acids
(
C6
C12),
None
When
ready
for
use,
consisting
of
a
mixture
of
the
end
use
not
less
than
56%
octanoic
concentration
is
not
acid
and
not
less
than
40%
to
exceed
39
ppm
decanoic
acid
Citric
acid
77
92
9
None
Decanoic
acid
334
48
5
When
ready
for
use,
the
end
use
concentration
is
not
to
exceed
90
ppm
total
active
fatty
acids
Ethanesulfonic
acid,
2
132
43
4
When
ready
for
use,
[
cyclohexyl
(
1
the
end
use
oxohexadecyl)
amino],
sodium
concentration
is
not
salt
to
exceed
237
ppm
Ethylenediaminetetraacetic
139
33
3
When
ready
for
use,
acid
(
EDTA),
disodium
salt
the
end
use
concentration
is
not
to
exceed
1,400
ppm
FD&
C
Yellow
No.
5
(
Tartrazine)
1934
21
0
None
(
conforming
to
21
CFR
74.705)
D
Gluconic
acid,
monosodium
527
07
1
When
ready
for
use,
salt
the
end
use
concentration
is
not
to
exceed
760
ppm
Hydriodic
acid
10034
85
2
When
ready
for
use,
the
end
use
concentration
is
not
to
exceed
25
ppm
of
titratable
iodine
Hydrogen
peroxide
7722
84
1
When
ready
for
use,
the
end
use
concentration
is
not
to
exceed
465
ppm
Hypochlorous
acid
7790
92
3
When
ready
for
use,
the
end
use
concentration
is
not
to
exceed
200
ppm
determined
as
total
available
chlorine
Iodine
7553
56
2
When
ready
for
use,
the
end
use
concentration
is
not
to
exceed
25
ppm
of
titratable
iodine
Lactic
acid
50
21
5
When
ready
for
use,
the
end
use
concentration
is
not
to
exceed
138
ppm
[
alpha]
Lauroyl[
<]
hydroxypoly
(
oxyethylene)
with
an
average
of
8
9
moles
ethylene
oxide,
average
molecular
weight
(
in
amu),
400
Nonanoic
acid
112
05
0
When
ready
for
use,
the
end
use
concentration
is
not
to
exceed
90
ppm
1
Octanamine,
N,
N
dimethyl
7378
99
6
When
ready
for
use,
the
end
use
concentration
is
not
to
exceed
113
ppm
1,2
Octanedisulfonic
acid
113669
58
2
When
ready
for
use,
the
end
use
concentration
is
not
to
exceed
102
ppm
1
Octanesulfonic
acid
3944
72
7
When
ready
for
use,
the
end
use
concentration
is
not
to
exceed
172
ppm
1
Octanesulfonic
acid,
sodium
5324
84
5
When
ready
for
use,
salt
the
end
use
concentration
is
not
to
exceed
297
ppm
[[
Page
71856]]
1
Octanesulfonic
acid,
2
113652
56
5
When
ready
for
use,
sulfino
the
end
use
concentration
is
not
to
exceed
102
ppm
Octanoic
acid
124
07
2
When
ready
for
use,
the
end
use
concentration
is
not
to
exceed
176
ppm
of
total
active
fatty
acids
Oxirane,
methyl,
polymer
with
11111
34
5
When
ready
for
use,
oxirane,
ether
with
(
1,2
the
end
use
ethanediyldinitrilo)
tetrakis[
concentration
is
not
propanol]
(
4:
1)
to
exceed
20
ppm
in
the
formulated
product
Oxychloro
species
(
including
None
When
ready
for
use,
chlorine
dioxide)
generated
the
end
use
by
acidification
of
an
concentration
is
not
aqueous
solution
of
sodium
to
exceed
200
ppm
of
chlorite
chlorine
dioxide
as
determined
by
the
method
entitled,
``
Iodometric
Method
for
the
Determination
of
Available
Chlorine
Dioxide''
(
50
250
ppm
available
chlorine
dioxide)
Peroxyacetic
acid
79
21
0
When
ready
for
use,
the
end
use
concentration
is
not
to
exceed
315
ppm
Peroxyoctanoic
acid
33734
57
5
When
ready
for
use,
the
end
use
concentration
is
not
to
exceed
122
ppm
Phosphonic
acid,
(
1
2809
21
4
When
ready
for
use,
hydroxyethylidene)
bis
the
end
use
concentration
is
not
to
exceed
34
ppm
Phosphoric
acid
7664
38
2
None
Phosphoric
acid,
monosodium
7558
80
7
When
ready
for
use,
salt
the
end
use
concentration
is
not
to
exceed
350
ppm
Potassium
iodide
7681
11
0
When
ready
for
use,
the
end
use
concentration
is
not
to
exceed
25
ppm
of
titratable
iodine
Propanoic
acid
79
09
4
When
ready
for
use,
the
end
use
concentration
is
not
to
exceed
297
ppm
2
Propanol
(
isopropanol)
67
63
0
2,6
Pyridinedicarboxylic
acid
499
83
2
When
ready
for
use,
the
end
use
concentration
is
not
to
exceed
1.2
ppm
Sodium
mono
and
None
When
ready
for
use,
didodecylphenoxy
the
end
use
benzenedisulfonate
concentration
is
not
to
exceed
1,920
ppm
Sulfuric
acid
7664
93
9
When
ready
for
use,
the
end
use
concentration
is
not
to
exceed
288
ppm
Sulfuric
acid
monododecyl
151
21
3
When
ready
for
use,
ester,
sodium
salt
(
sodium
the
end
use
lauryl
sulfate)
concentration
is
not
to
exceed
350
ppm
(
c)
The
following
chemical
substances
when
used
as
ingredients
in
an
antimicrobial
pesticide
formulation
may
be
applied
to:
Foodprocessing
equipment
and
utensils.
Pesticide
chemical
CAS
No.
Limits
Acetic
acid
64
19
7
When
ready
for
use,
the
end
use
concentration
is
not
to
exceed
686
ppm
Acetic
acid,
chloro,
sodium
68608
66
2
When
ready
for
use,
salt,
reaction
products
with
the
end
use
4,5
dihydro
2
undecyl
1H
concentration
is
not
imidazole
1
ethanol
and
to
exceed
42
ppm
sodium
hydroxide
chloroacetic
acid
[
alpha]
Alkyl(
C10
C14)[
<]
hydroxypoly(
oxyethylene)
poly
(
oxypropylene)
average
molecular
weight
(
in
amu),
768
to
837
[
alpha]
Alkyl(
C11
C15)[
<]
hydroxypoly(
oxyethylene)
with
ethylene
oxide
content
9
to
13
moles
[
alpha]
Alkyl(
C12
C15)[
<]
hydroxypoly
(
oxyethylene)
polyoxypropylene,
average
molecular
weight
(
in
amu),
965
[[
Page
71857]]
[
alpha]
Alkyl(
C12
C18)[
<]
hydroxypoly(
oxyethylene)
poly(
oxypropylene)
average
molecular
weight
(
in
amu),
950
to
1,120
Alkyl
(
C12
C15)
monoether
of
None
None
mixed
(
ethylene
propylene)
polyalkylene
glycol,
cloud
point
of
70
77
[
deg]
C
in
1%
aqueous
solution,
average
molecular
weight
(
in
amu),
807
Ammonium
chloride
12125
02
9
When
ready
for
use,
the
end
use
concentration
is
not
to
exceed
48
ppm
Benzenesulfonamide,
N
chloro
4
127
65
1
None
methyl,
sodium
salt
Benzenesulfonic
acid,
dodecyl
27176
87
0
When
ready
for
use,
the
end
use
concentration
is
not
to
exceed
400
ppm
Benzenesulfonic
acid,
dodecyl
25155
30
0
When
ready
for
use,
,
sodium
salt
the
end
use
concentration
is
not
to
exceed
430
ppm
Benzenesulfonic
acid,
30260
73
2
When
ready
for
use,
oxybis[
dodecyl
the
end
use
concentration
is
not
to
exceed
474
ppm
[
1,1'
Biphenyl]
2
ol
90
43
7
When
ready
for
use,
the
end
use
concentration
is
not
to
exceed
400
ppm
Boric
acid,
sodium
salt
7775
19
1
Butanedioic
acid,
octenyl
28805
58
5
When
ready
for
use,
the
end
use
concentration
is
not
to
exceed
156
ppm
Butanedioic
acid,
sulfo,
1,4
1639
66
3
None
dioctyl
ester,
sodium
salt
Butoxy
monoether
of
mixed
None
None
(
ethylene
propylene)
polyalkylene
glycol,
cloudpoint
of
90
100
[
deg]
C
in
0.5
aqueous
solution,
average
molecular
weight
(
in
amu),
3,300
Butoxy
monoether
of
mixed
None
None
(
ethylene
propylene)
polyalkylene
glycol,
minimum
average
molecular
weight
(
in
amu),
2,400
Calcium
bromide
7789
41
5
When
ready
for
use,
the
end
use
concentration
is
not
to
exceed
200
ppm
total
available
halogen
Calcium
chloride
10043
52
4
When
ready
for
use,
the
end
use
concentration
is
not
to
exceed
17
ppm
n
Carboxylic
acids
(
C6
C12),
None
When
ready
for
use,
consisting
of
a
mixture
of
the
end
use
not
less
than
56%
octanoic
concentration
is
not
acid
and
not
less
than
40%
to
exceed
39
ppm
decanoic
acid
Citric
acid
77
92
9
None
3
Cyclohexene
1
methanol,
98
55
5
None
[
alpha],[
alpha],
4
trimethyl
D&
C
Blue
No.
1
(
methylene
blue)
61
73
4
When
ready
for
use,
the
end
use
concentration
is
not
to
exceed
0.4
ppm
1
Decanaminium,
N
decyl
N,
N
7173
51
5
When
ready
for
use,
dimethyl,
chloride
the
end
use
concentration
is
not
to
exceed
200
ppm
of
active
quaternary
compound
Decanoic
acid
334
48
5
When
ready
for
use,
the
end
use
concentration
is
not
to
exceed
234
ppm
total
active
fatty
acids
Dextrin
9004
53
9
When
ready
for
use,
the
end
use
concentration
is
not
to
exceed
16
ppm
Ethanesulfonic
acid,
2
132
43
4
When
ready
for
use,
[
cyclohexyl
(
1
the
end
use
oxohexadecyl)
amino],
sodium
concentration
is
not
salt
to
exceed
237
ppm
Ethanol
64
17
5
None
Ethanol,
2
butoxy
111
76
2
None
Ethanol,
2(
2
ethoxyethoxy)
111
90
0
None
[[
Page
71858]]
Ethylenediaminetetraacetic
139
33
3
When
ready
for
use,
acid
(
EDTA),
disodium
salt
the
end
use
concentration
is
not
to
exceed
1,400
ppm
Ethylenediaminetetraacetic
64
02
8
None
acid
(
EDTA),
tetrasodium
salt
Fatty
acids,
coco,
potassium
61789
30
8
None
salts
Fatty
acids,
tall
oil,
68309
27
3
When
ready
for
use,
sulfonated,
sodium
salts
the
end
use
concentration
is
not
to
exceed
66
ppm
FD&
C
Yellow
No.
5
(
Tartrazine)
1934
21
0
None
(
conforming
to
21
CFR
74.705)
D
Gluconic
acid,
monosodium
527
07
1
When
ready
for
use,
salt
the
end
use
concentration
is
not
to
exceed
760
ppm
Hydriodic
acid
10034
85
2
When
ready
for
use,
the
end
use
concentration
is
not
to
exceed
25
ppm
of
titratable
iodine
Hydrogen
peroxide
7722
84
1
When
ready
for
use,
the
end
use
concentration
is
not
to
exceed
1,100
ppm
Hypochlorous
acid
7790
92
3
When
ready
for
use,
the
end
use
concentration
is
not
to
exceed
200
ppm
determined
as
total
available
chlorine
Hypochlorous
acid,
calcium
7778
54
3
When
ready
for
use,
salt
the
end
use
concentration
is
not
to
exceed
200
ppm
determined
as
total
available
chlorine
Hypochlorous
acid,
lithium
13840
33
0
When
ready
for
use,
salt
the
end
use
concentration
is
not
to
exceed
200
ppm
determined
as
total
available
chlorine
and
30
ppm
lithium
Hypochlorous
acid,
potassium
7778
66
7
When
ready
for
use,
salt
the
end
use
concentration
is
not
to
exceed
200
ppm
determined
as
available
chlorine
Hypochlorous
acid,
sodium
salt
7681
52
9
When
ready
for
use,
the
end
use
concentration
is
not
to
exceed
200
ppm
determined
as
available
chlorine
Iodine
7553
56
2
When
ready
for
use,
the
end
use
concentration
is
not
to
exceed
25
ppm
of
titratable
iodine
Lactic
acid
50
21
5
None
[
alpha]
Lauroyl[
<]
hydroxypoly
(
oxyethylene)
with
an
average
of
8
9
moles
ethylene
oxide,
average
molecular
weight
(
in
amu),
400
Magnesium
oxide
1309
48
4
None
Naphthalene
sulfonic
acid,
1321
69
3
When
ready
for
use,
sodium
salt
the
end
use
concentration
is
not
to
exceed
332
ppm
total
naphthalene
sulfonates
Naphthalene
sulfonic
acid
None
When
ready
for
use,
sodium
salt,
and
its
methyl,
the
end
use
dimethyl
and
trimethyl
concentration
is
not
derivatives
to
exceed
332
ppm
total
naphthalene
sulfonates
Naphthalene
sulfonic
acid
None
When
ready
for
use,
sodium
salt,
and
its
methyl,
the
end
use
dimethyl
and
trimethyl
concentration
is
not
derivatives
alkylated
at
3%
to
exceed
332
ppm
by
weight
with
C6
C9
linear
total
naphthalene
olefins
sulfonates
Neodecanoic
acid
26896
20
8
When
ready
for
use,
the
end
use
concentration
is
not
to
exceed
174
ppm
Nonanoic
acid
112
05
0
When
ready
for
use,
the
end
use
concentration
is
not
to
exceed
90
ppm
[
alpha](
p
Nonylphenyl)
None
None
[<
g]
hydroxypoly(
oxyethylene)
maximum
average
molecular
weight
(
in
amu),
748
[
alpha](
p
Nonylphenol)
None
None
[<
g]
hydroxypoly(
oxyethylene)
average
poly(
oxyethylene)
content
11
moles
[
alpha](
p
Nonylphenyl)
None
None
[<
g]
hydroxypoly(
oxyethylene)
produced
by
the
condensation
of
1
mole
p
nonylphenol
with
9
to12
moles
ethylene
oxide
[[
Page
71859]]
[
alpha](
p
Nonylphenyl)
None
None
[<
g]
hydroxypoly(
oxyethylene),
9
to
13
moles
ethylene
oxide
Octadecanoic
acid,
calcium
1592
23
0
When
ready
for
use,
salt
the
end
use
concentration
is
not
to
exceed
16
ppm
9
Octadecenoic
acid
(
9Z),
68988
76
1
When
ready
for
use,
sulfonated
the
end
use
concentration
is
not
to
exceed
312
ppm
9
Octadecenoic
acid
(
9Z)
68443
05
0
When
ready
for
use,
sulfonated,
sodium
salts
the
end
use
concentration
is
not
to
exceed
200
ppm
1
Octanamine,
N,
N
dimethyl
7378
99
6
When
ready
for
use,
the
end
use
concentration
is
not
to
exceed
113
ppm
1,2
Octanedisulfonic
acid
113669
58
2
When
ready
for
use,
the
end
use
concentration
is
not
to
exceed
102
ppm
1
Octanesulfonic
acid
3944
72
7
When
ready
for
use,
the
end
use
concentration
is
not
to
exceed
172
ppm
1
Octanesulfonic
acid,
sodium
5324
84
5
When
ready
for
use,
salt
the
end
use
concentration
is
not
to
exceed
312
ppm
1
Octanesulfonic
acid,
2
113652
56
5
When
ready
for
use,
sulfino
the
end
use
concentration
is
not
to
exceed
102
ppm
Octanoic
acid
124
07
2
When
ready
for
use,
the
end
use
concentration
is
not
to
exceed
234
ppm
of
total
active
fatty
acids
Oxirane,
methyl,
polymer
with
9003
11
6
None
oxirane,
minimum
molecular
weight
(
in
amu),
1,900
Oxirane,
methyl,
polymer
with
106392
12
5
None
oxirane,
block,
average
molecular
weight
(
in
amu),
1,900
Oxirane,
methyl,
polymer
with
None
None
oxirane,
block,
minimum
average
molecular
weight
(
in
amu),
2,000
Oxirane,
methyl,
polymer
with
None
None
oxirane,
block,
27
to
31
moles
of
polyoxypropylene,
average
molecular
weight
(
in
amu)
2,000
Oxirane,
methyl,
polymer
with
11111
34
5
When
ready
for
use,
oxirane,
ether
with
(
1,2
the
end
use
ethanediyldinitrilo)
tetrakis[
concentration
is
not
propanol]
(
4:
1)
to
exceed
20
ppm
Oxychloro
species
None
When
ready
for
use,
(
predominantly
chlorite,
the
end
use
chlorate
and
chlorine
dioxide
concentration
is
not
in
an
equilibrium
mixture)
to
exceed
200
ppm
of
generated
either:
By
directly
chlorine
dioxide
as
metering
a
concentrated
determined
by
the
chlorine
dioxide
solution
method
entitled,
prepared
just
prior
to
use,
``
Iodometric
Method
into
potable
water,
or
by
for
the
acidification
of
an
aqueous
Determination
of
alkaline
solution
of
Available
Chlorine
oxychloro
species
Dioxide''
(
50
250
(
predominately
chlorite
and
ppm
available
chlorate)
followed
by
chlorine
dioxide)
dilution
with
potable
water
Oxychloro
species
(
including
None
When
ready
for
use,
chlorine
dioxide)
generated
the
end
use
by
acidification
of
an
concentration
is
not
aqueous
solution
of
sodium
to
exceed
200
ppm
of
chlorite
chlorine
dioxide
as
determined
by
the
method
entitled,
``
Iodometric
Method
for
the
Determination
of
Available
Chlorine
Dioxide''
(
50
250
ppm
available
chlorine
dioxide)
2,4
Pentanediol,
2
methyl
107
41
5
None
Peroxyacetic
acid
79
21
0
When
ready
for
use,
the
end
use
concentration
is
not
to
exceed
315
ppm
in
the
formulated
product
Peroxyoctanoic
acid
33734
57
5
When
ready
for
use,
the
end
use
concentration
is
not
to
exceed
122
ppm
Phenol,
4
chloro
2
120
32
1
When
ready
for
use,
(
phenylmethyl)
the
end
use
concentration
is
not
to
exceed
320
ppm
Phenol,
4(
1,1
dimethylpropyl)
80
46
6
When
ready
for
use,
the
end
use
concentration
is
not
to
exceed
80
ppm
[[
Page
71860]]
Phosphonic
acid,
(
1
2809
21
4
When
ready
for
use,
hydroxyethylidene)
bis
the
end
use
concentration
is
not
to
exceed
34
ppm
Phosphoric
acid
7664
38
2
None
Phosphoric
acid,
monosodium
7558
80
7
When
ready
for
use,
salt
the
end
use
concentration
is
not
to
exceed
350
ppm
Phosphoric
acid,
trisodium
7601
54
9
When
ready
for
use,
salt
the
end
use
concentration
is
not
to
exceed
5916
ppm
in
the
formulated
product
Poly(
oxy
1,2
ethanediyl),
None
None
[
alpha][(
1,1,3,3
tetramethylbutyl)
phenyl]
[<
g]
hydroxy,
produced
with
one
mole
of
the
phenol
and
4
to
14
moles
ethylene
oxide
Potassium
bromide
7758
02
3
When
ready
for
use,
the
end
use
concentration
is
not
to
exceed
200
ppm
total
available
halogen
Potassium
iodide
7681
11
0
When
ready
for
use,
the
end
use
concentration
is
not
to
exceed
25
ppm
of
titratable
iodine
Potassium
permanganate
7722
64
7
When
ready
for
use,
the
end
use
concentration
is
not
to
exceed
0.7
ppm
Propanoic
acid
79
09
4
When
ready
for
use,
the
end
use
concentration
is
not
to
exceed
297
ppm
2
Propanol
(
isopropanol)
67
63
0
None
2,6
Pyridinedicarboxylic
acid
499
83
2
When
ready
for
use,
the
end
use
concentration
is
not
to
exceed
1.2
ppm
Quaternary
ammonium
compounds,
8001
54
5
When
ready
for
use,
alkyl
(
C12
C16)
the
end
use
benzyldimethyl,
chlorides,
concentration
is
not
to
exceed
200
ppm
of
active
quaternary
compound
Quaternary
ammonium
compounds,
8001
54
5
When
ready
for
use,
alkyl
(
C12
C18)
the
end
use
benzyldimethyl,
chlorides
concentration
is
not
to
exceed
200
ppm
of
active
quaternary
compound
Quaternary
ammonium
compounds,
None
When
ready
for
use,
n
alkyl
(
C12
C14)
dimethyl
the
end
use
ethylbenzyl
ammonium
concentration
is
not
chloride,
average
molecular
to
exceed
200
ppm
of
weight
(
in
amu),
377
to
384
active
quaternary
compound
Quaternary
ammonium
compounds,
None
When
ready
for
use,
n
alkyl
(
C12
C18)
dimethyl
the
end
use
ethylbenzyl
ammonium
chloride
concentration
is
not
average
molecular
weight
(
in
to
exceed
200
ppm
of
amu)
384
active
quaternary
compound
Quaternary
ammonium
compounds,
None
When
ready
for
use,
di
n
Alkyl
(
C8
C10)
dimethyl
the
end
use
ammonium
chloride,
average
concentration
is
not
molecular
weight
(
in
amu),
to
exceed
240
ppm
of
332
to
361
active
quaternary
compound
Sodium[
alpha]
alkyl(
C12
C15)
None
None
[<
g]
hydroxypoly
(
oxyethylene)
sulfate
with
the
poly(
oxyethylene)
content
averaging
one
mole
Sodium
bicarbonate
144
55
8
When
ready
for
use,
the
end
use
concentration
is
not
to
exceed
120
ppm
Sodium
bromide
7647
15
6
When
ready
for
use,
the
end
use
concentration
is
not
to
exceed
200
ppm
total
available
halogen
Sodium
iodide
7681
82
5
When
ready
for
use,
the
end
use
concentration
is
not
to
exceed
25
ppm
of
titratable
iodine
Sodium
mono
and
None
When
ready
for
use,
didodecylphenoxy
the
end
use
benzenedisulfonate
concentration
is
not
to
exceed
1,920
ppm
Starch
9005
25
8
When
ready
for
use,
the
end
use
concentration
is
not
to
exceed
16
ppm
Sulfuric
acid
7664
93
9
When
ready
for
use,
the
end
use
concentration
is
not
to
exceed
228
ppm
Sulfuric
acid
monododecyl
151
21
3
None
ester,
sodium
salt
(
sodium
lauryl
sulfate)
[[
Page
71861]]
1,3,5
Triazine
2,4,6(
1H,
3H,
5H)
2782
57
2
When
ready
for
use,
trione,
1,3
dichloro
the
end
use
concentration
is
not
to
exceed
100
ppm
determined
as
total
available
chlorine
1,3,5
Triazine
2,4,6(
1H,
3H,
5H)
2244
21
5
When
ready
for
use,
trione,
1,3
dichloro,
the
end
use
potassium
salt
concentration
is
not
to
exceed
100
ppm
determined
as
total
available
chlorine
1,3,5
Triazine
2,4,6(
1H,
3H,
5H)
2893
78
9
When
ready
for
use,
trione,
1,3
dichloro,
sodium
the
end
use
salt
concentration
is
not
to
exceed
100
ppm
determined
as
total
available
chlorine
1,3,5
Triazine
2,4,6(
1H,
3H,
5H)
87
90
1
When
ready
for
use,
trione,
1,3,5
trichloro
the
end
use
concentration
is
not
to
exceed
100
ppm
determined
as
total
available
chlorine
1,3,5
Triazine,
N,
N',
N''
7673
09
8
When
ready
for
use,
trichloro
2,4,6
triamino
the
end
use
concentration
is
not
to
exceed
200
ppm
as
total
available
chlorine
Xylenesulfonic
acid,
sodium
1300
72
7
When
ready
for
use,
salt
the
end
use
concentration
is
not
to
exceed
62
ppm
[
FR
Doc.
02
30473
Filed
12
2
02;
8:
45
am]
BILLING
CODE
6560
50
S
| epa | 2024-06-07T20:31:44.062487 | regulations | {
"license": "Public Domain",
"url": "https://downloads.regulations.gov/EPA-HQ-OPP-2002-0278-0001/content.txt"
} |
EPA-HQ-OPP-2002-0279-0001 | Notice | "2002-11-13T05:00:00" | Pesticide Products; Registration Applications | 68864
Federal
Register
/
Vol.
67,
No.
219
/
Wednesday,
November
13,
2002
/
Notices
and
Policy
(
7201M),
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460
0001;
telephone
number:
(
202)
564
8450;
fax
number:
(
202)
564
8382;
email
address:
lewis.
paul@
epa.
gov.
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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.
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.
List
of
Subjects
Environmental
protection,
Pesticides
and
pests.
Dated:
November
5,
2002.
Joseph
J.
Merenda,
Jr.,
Director,
Office
of
Science
Coordination
and
Policy.
[
FR
Doc.
02
28841
Filed
11
12
02;
8:
45
am]
BILLING
CODE
6560
50
S
ENVIRONMENTAL
PROTECTION
AGENCY
[
OPP
2002
0279;
FRL
7277
2]
Pesticide
Products;
Registration
Applications
AGENCY:
Environmental
Protection
Agency
(
EPA).
ACTION:
Notice.
SUMMARY:
This
notice
announces
receipt
of
applications
to
register
pesticide
products
containing
new
active
ingredients
not
included
in
any
previously
registered
products
pursuant
to
the
provisions
of
section
3(
c)(
4)
of
the
Federal
Insecticide,
Fungicide,
and
Rodenticide
Act
(
FIFRA),
as
amended.
DATES:
Written
comments,
identified
by
the
docket
ID
number
OPP
2002
0279,
must
be
received
on
or
before
December
13,
2002.
ADDRESSES:
Comments
may
be
submitted
electronically,
by
mail,
or
through
hand
delivery/
courier.
Follow
the
detailed
instructions
as
provided
in
Unit
I.
of
the
SUPPLEMENTARY
INFORMATION.
FOR
FURTHER
INFORMATION
CONTACT:
Joanne
I.
Miller,
Registration
Division
(
7505C),
Office
of
Pesticide
Programs,
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460
0001;
telephone
number:
(
703)
305
6224;
e
mail
address:
miller.
joanne@
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
a
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
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.
To
determine
whether
you
or
your
business
may
be
affected
by
this
action,
you
should
carefully
examine
the
applicability
provisions
in
unit
II
of
this
notice.
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
0279.
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.
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.
Certain
types
of
information
will
not
be
placed
in
the
EPA
Dockets.
Information
claimed
as
CBI
and
other
information
whose
disclosure
is
restricted
by
statute,
which
is
not
included
in
the
official
public
docket,
will
not
be
available
for
public
viewing
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13,
2002
/
Notices
in
EPA's
electronic
public
docket.
EPA's
policy
is
that
copyrighted
material
will
not
be
placed
in
EPA's
electronic
public
docket
but
will
be
available
only
in
printed,
paper
form
in
the
official
public
docket.
To
the
extent
feasible,
publicly
available
docket
materials
will
be
made
available
in
EPA's
electronic
public
docket.
When
a
document
is
selected
from
the
index
list
in
EPA
Dockets,
the
system
will
identify
whether
the
document
is
available
for
viewing
in
EPA's
electronic
public
docket.
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.
EPA
intends
to
work
towards
providing
electronic
access
to
all
of
the
publicly
available
docket
materials
through
EPA's
electronic
public
docket.
For
public
commenters,
it
is
important
to
note
that
EPA's
policy
is
that
public
comments,
whether
submitted
electronically
or
in
paper,
will
be
made
available
for
public
viewing
in
EPA's
electronic
public
docket
as
EPA
receives
them
and
without
change,
unless
the
comment
contains
copyrighted
material,
CBI,
or
other
information
whose
disclosure
is
restricted
by
statute.
When
EPA
identifies
a
comment
containing
copyrighted
material,
EPA
will
provide
a
reference
to
that
material
in
the
version
of
the
comment
that
is
placed
in
EPA's
electronic
public
docket.
The
entire
printed
comment,
including
the
copyrighted
material,
will
be
available
in
the
public
docket.
Public
comments
submitted
on
computer
disks
that
are
mailed
or
delivered
to
the
docket
will
be
transferred
to
EPA's
electronic
public
docket.
Public
comments
that
are
mailed
or
delivered
to
the
Docket
will
be
scanned
and
placed
in
EPA's
electronic
public
docket.
Where
practical,
physical
objects
will
be
photographed,
and
the
photograph
will
be
placed
in
EPA's
electronic
public
docket
along
with
a
brief
description
written
by
the
docket
staff.
C.
How
and
To
Whom
Do
I
Submit
Comments?
You
may
submit
comments
electronically,
by
mail,
or
through
hand
delivery/
courier.
To
ensure
proper
receipt
by
EPA,
identify
the
appropriate
docket
ID
number
in
the
subject
line
on
the
first
page
of
your
comment.
Please
ensure
that
your
comments
are
submitted
within
the
specified
comment
period.
Comments
received
after
the
close
of
the
comment
period
will
be
marked
``
late.''
EPA
is
not
required
to
consider
these
late
comments.
If
you
wish
to
submit
CBI
or
information
that
is
otherwise
protected
by
statute,
please
follow
the
instructions
in
Unit
I.
D.
Do
not
use
EPA
Dockets
or
e
mail
to
submit
CBI
or
information
protected
by
statute.
1.
Electronically.
If
you
submit
an
electronic
comment
as
prescribed
in
this
unit,
EPA
recommends
that
you
include
your
name,
mailing
address,
and
an
email
address
or
other
contact
information
in
the
body
of
your
comment.
Also
include
this
contact
information
on
the
outside
of
any
disk
or
CD
ROM
you
submit,
and
in
any
cover
letter
accompanying
the
disk
or
CD
ROM.
This
ensures
that
you
can
be
identified
as
the
submitter
of
the
comment
and
allows
EPA
to
contact
you
in
case
EPA
cannot
read
your
comment
due
to
technical
difficulties
or
needs
further
information
on
the
substance
of
your
comment.
EPA's
policy
is
that
EPA
will
not
edit
your
comment,
and
any
identifying
or
contact
information
provided
in
the
body
of
a
comment
will
be
included
as
part
of
the
comment
that
is
placed
in
the
official
public
docket,
and
made
available
in
EPA's
electronic
public
docket.
If
EPA
cannot
read
your
comment
due
to
technical
difficulties
and
cannot
contact
you
for
clarification,
EPA
may
not
be
able
to
consider
your
comment.
i.
EPA
Dockets.
Your
use
of
EPA's
electronic
public
docket
to
submit
comments
to
EPA
electronically
is
EPA's
preferred
method
for
receiving
comments.
Go
directly
to
EPA
Dockets
at
http://
www.
epa.
gov/
edocket,
and
follow
the
online
instructions
for
submitting
comments.
Once
in
the
system,
select
``
search,''
and
then
key
in
docket
ID
number
OPP
2002
0279
The
system
is
an
``
anonymous
access''
system,
which
means
EPA
will
not
know
your
identity,
e
mail
address,
or
other
contact
information
unless
you
provide
it
in
the
body
of
your
comment.
ii.
E
mail.
Comments
may
be
sent
by
e
mail
to
opp
docket@
epa.
gov,
Attention:
Docket
ID
Number
OPP
2002
0279.
In
contrast
to
EPA's
electronic
public
docket,
EPA's
e
mail
system
is
not
an
``
anonymous
access''
system.
If
you
send
an
e
mail
comment
directly
to
the
docket
without
going
through
EPA's
electronic
public
docket,
EPA's
e
mail
system
automatically
captures
your
e
mail
address.
E
mail
addresses
that
are
automatically
captured
by
EPA's
e
mail
system
are
included
as
part
of
the
comment
that
is
placed
in
the
official
public
docket,
and
made
available
in
EPA's
electronic
public
docket.
iii.
Disk
or
CD
ROM.
You
may
submit
comments
on
a
disk
or
CD
ROM
that
you
mail
to
the
mailing
address
identified
in
Unit
I.
C.
2.
These
electronic
submissions
will
be
accepted
in
WordPerfect
or
ASCII
file
format.
Avoid
the
use
of
special
characters
and
any
form
of
encryption.
2.
By
mail.
Send
your
comments
to:
Public
Information
and
Records
Integrity
Branch
(
PIRIB),
Office
of
Pesticide
Programs
(
OPP),
Environmental
Protection
Agency
(
7502C),
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460
0001,
Attention:
Docket
ID
Number
OPP
2002
0279.
3.
By
hand
delivery
or
courier.
Deliver
your
comments
to:
Public
Information
and
Records
Integrity
Branch
(
PIRIB),
Office
of
Pesticide
Programs
(
OPP),
Environmental
Protection
Agency,
Rm.
119,
Crystal
Mall
#
2,
1921
Jefferson
Davis
Hwy.,
Arlington,
VA.,
Attention:
Docket
ID
Number
OPP
2002
0279.
Such
deliveries
are
only
accepted
during
the
docket's
normal
hours
of
operation
as
identified
in
Unit
I.
B.
1.
D.
How
Should
I
Submit
CBI
To
the
Agency?
Do
not
submit
information
that
you
consider
to
be
CBI
electronically
through
EPA's
electronic
public
docket
or
by
e
mail.
You
may
claim
information
that
you
submit
to
EPA
as
CBI
by
marking
any
part
or
all
of
that
information
as
CBI
(
if
you
submit
CBI
on
disk
or
CD
ROM,
mark
the
outside
of
the
disk
or
CD
ROM
as
CBI
and
then
identify
electronically
within
the
disk
or
CD
ROM
the
specific
information
that
is
CBI).
Information
so
marked
will
not
be
disclosed
except
in
accordance
with
procedures
set
forth
in
40
CFR
part
2.
In
addition
to
one
complete
version
of
the
comment
that
includes
any
information
claimed
as
CBI,
a
copy
of
the
comment
that
does
not
contain
the
information
claimed
as
CBI
must
be
submitted
for
inclusion
in
the
public
docket
and
EPA's
electronic
public
docket.
If
you
submit
the
copy
that
does
not
contain
CBI
on
disk
or
CD
ROM,
mark
the
outside
of
the
disk
or
CD
ROM
clearly
that
it
does
not
contain
CBI.
Information
not
marked
as
CBI
will
be
included
in
the
public
docket
and
EPA's
electronic
public
docket
without
prior
notice.
If
you
have
any
questions
about
CBI
or
the
procedures
for
claiming
CBI,
please
consult
the
person
listed
under
FOR
FURTHER
INFORMATION
CONTACT.
E.
What
Should
I
Consider
as
I
Prepare
My
Comments
for
EPA?
You
may
find
the
following
suggestions
helpful
for
preparing
your
comments:
1.
Explain
your
views
as
clearly
as
possible.
2.
Describe
any
assumptions
that
you
used.
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Notices
3.
Provide
copies
of
any
technical
information
and/
or
data
you
used
that
support
your
views.
4.
If
you
estimate
potential
burden
or
costs,
explain
how
you
arrived
at
the
estimate
that
you
provide.
5.
Provide
specific
examples
to
illustrate
your
concerns.
6.
Offer
alternative
ways
to
improve
the
registration
activity.
7.
Make
sure
to
submit
your
comments
by
the
deadline
in
this
notice.
8.
To
ensure
proper
receipt
by
EPA,
be
sure
to
identify
the
docket
ID
number
assigned
to
this
action
in
the
subject
line
on
the
first
page
of
your
response.
You
may
also
provide
the
name,
date,
and
Federal
Register
citation.
II.
Registration
Applications
EPA
received
applications
as
follows
to
register
pesticide
products
containing
active
ingredients
not
included
in
any
previously
registered
products
pursuant
to
the
provision
of
section
3(
c)(
4)
of
FIFRA.
Notice
of
receipt
of
these
applications
does
not
imply
a
decision
by
the
Agency
on
the
applications.
Products
Containing
Active
Ingredients
not
Included
in
any
Previously
Registered
Products
1.
File
symbol:
71771
T.
Applicant:
Nichino
America,
Inc.,
4550
New
Linden
Hill
Road,
Wilmington,
DE
19808.
Product
name:
ET
751
2.5%
EC
Herbicide.
Product
type:
Herbicide.
Active
ingredient:
Pyraflufen
ethyl
(
ethyl
2
chloro
5(
4
chloro
5
difluoromethoxy
1
methylpyrazol
3
yl)
4
fluorophenoxyacetate)
at
2.5%.
Proposed
classification/
Use:
None.
For
use
on
terrestrial
non
cropland
to
control
broadleaf
weeds.
2.
File
symbol:
71711
A.
Applicant:
Nichino
America,
Inc.
Product
name:
ET
751
Technical.
Product
type:
Herbicide.
Active
ingredient:
Pyraflufenethyl
at
97.9%.
Proposed
classification/
Use:
None.
For
manufacturing
use
of
end
use
products
to
be
used
to
control
certain
broadleaf
weeds
on
terrestrial
non
cropland.
3.
File
symbol:
59639
RNO.
Applicant:
Valent
U.
S.
A.
Corporation,
1333
North
Carolina
Blvd.,
Suite
600,
P.
O.
Box
8025,
Walnut
Creek,
CA
94596
8025.
Product
name:
S
3153
Flufenpyr
ethyl
Technical.
Product
type:
Herbicide.
Active
ingredient:
Flufenpyr
ethyl,
ethyl
[
2
chloro
4
fluoro
5(
5
methyl
6
oxo
4
trifluoromethyl
1,6
dihydropyridazin
1
yl)
phenoxy]
acetate
at
98.0%.
Proposed
classification/
Use:
None.
For
formulation
into
herbicide
products
to
control
postemergence
broadleaf
weed
species
in
field
corn,
forage;
field
corn,
grain;
field
corn,
stover;
soybean,
seed;
sugarcane.
4.
File
symbol:
59639
RRN.
Applicant:
Valent
U.
S.
A.
Corporation.
Product
name:
S
3153
WDG
Herbicide.
Product
type:
Herbicide.
Active
ingredient:
Flufenpyr
ethyl
at
57.6%.
Proposed
classification/
Use:
None.
For
manufacturing
use
of
end
use
products
to
be
used
to
control
postemergence
broadleaf
weed
species
in
field
corn,
soybeans
and
sugarcane.
5.
File
symbol:
59639
RRR.
Applicant:
Valent
U.
S.
A.
Corporation.
Product
name:
S
3153
Atrazine
WDG.
Product
type:
Herbicide.
Active
ingredient:
Flufenpyr
ethyl
75.0%.
Proposed
classification/
Use:
None.
For
manufacturing
use
of
end
use
products
to
be
used
to
control
postemergence
broadleaf
weed
species
in
field
corn
and
sugarcane.
List
of
Subjects
Environmental
protection,
Pesticides
and
pest.
Dated:
October
27,
2002.
Debra
Edwards,
Acting
Director,
Registration
Division,
Office
of
Pesticide
Programs.
[
FR
Doc.
02
28504
Filed
11
12
02;
8:
45am]
BILLING
CODE
6560
50
S
ENVIRONMENTAL
PROTECTION
AGENCY
[
OPP
2002
0285;
FRL
7278
1]
Draft
Guidance
on
How
to
Comply
with
Data
Citation
Regulations;
Notice
of
Availability
AGENCY:
Environmental
Protection
Agency
(
EPA).
ACTION:
Notice.
SUMMARY:
This
notice
announces
the
availability
of
draft
guidance
on
how
to
comply
with
the
Agency's
data
citation
requirements
for
registration
of
new
pesticide
products
under
the
Federal
Insecticide,
Fungicide,
and
Rodenticide
Act.
When
applicants
do
not
fully
comply
with
the
data
citation
regulations,
the
result
can
be
significant
delays
in
the
processing
of
registration
applications,
the
potential
for
an
increase
in
adversarial
petitions
being
submitted
to
the
Agency
by
data
submitters,
and
increased
expenditures
of
resources
for
all
involved,
the
Agency,
applicants,
and
data
submitters.
EPA
believes
that
the
guidance
provided
through
the
notice
will
assist
applicants
comply
with
the
data
citation
requirements
and
ultimately
result
in
fewer
delays
in
the
registration
process.
DATES:
Comments,
identified
by
docket
ID
number
OPP
2002
0285,
must
be
received
on
or
before
December
13,
2002.
ADDRESSES:
Comments
may
be
submitted
electronically,
by
mail,
or
through
hand
delivery/
courier.
Follow
the
detailed
instructions
as
provided
in
Unit
I.
of
the
SUPPLEMENTARY
INFORMATION.
FOR
FURTHER
INFORMATION
CONTACT:
Peter
Caulkins,
Registration
Division
(
7505C),
Office
of
Pesticide
Programs,
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460
0001;
telephone
number:
(
703)
305
5447;
fax
number:
(
703)
305
6920;
e
mail
address:
caulkins.
peter@
epa.
gov.
SUPPLEMENTARY
INFORMATION:
I.
General
Information
A.
Does
this
Action
Apply
to
Me?
You
may
be
potentially
affected
by
this
action
if
you
submit
applications
for
registration
of
pesticides
pursuant
to
the
Federal
Insecticide,
Fungicide,
and
Rodenticide
Act
(
FIFRA),
or
if
you
submit
data
to
the
Agency
in
support
of
registration
or
reregistration
under
FIFRA.
Potentially
affected
entities
may
include,
but
are
not
limited
to:
Pesticide
Manufacturing
(
NAICS
32532)
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
0285.
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
VerDate
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31>
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15:
21
Nov
12,
2002
Jkt
200001
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00000
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FR\
FM\
13NON1.
SGM
13NON1
| epa | 2024-06-07T20:31:44.074895 | regulations | {
"license": "Public Domain",
"url": "https://downloads.regulations.gov/EPA-HQ-OPP-2002-0279-0001/content.txt"
} |
EPA-HQ-OPP-2002-0280-0001 | Proposed Rule | "2002-11-20T05:00:00" | Pesticides; Minimal Risk Tolerance Exemptions | 70036
Federal
Register
/
Vol.
67,
No.
224
/
Wednesday,
November
20,
2002
/
Proposed
Rules
may
result
in
estimated
costs
to
State,
local,
or
tribal
governments
in
the
aggregate;
or
to
the
private
sector,
of
$
100
million
or
more.
Under
section
205,
EPA
must
select
the
most
costeffective
and
least
burdensome
alternative
that
achieves
the
objectives
of
the
rule
and
is
consistent
with
statutory
requirements.
Section
203
requires
EPA
to
establish
a
plan
for
informing
and
advising
any
small
governments
that
may
be
significantly
or
uniquely
impacted
by
the
rule.
EPA
has
determined
that
the
proposed
action
does
not
include
a
Federal
mandate
that
may
result
in
estimated
costs
of
$
100
million
or
more
to
either
State,
local,
or
tribal
governments
in
the
aggregate,
or
to
the
private
sector.
This
proposed
Federal
action
acts
on
pre
existing
requirements
under
State
or
local
law,
and
imposes
no
new
requirements.
Accordingly,
no
additional
costs
to
State,
local,
or
tribal
governments,
or
to
the
private
sector,
result
from
this
action.
H.
National
Technology
Transfer
and
Advancement
Act
Section
12
of
the
National
Technology
Transfer
and
Advancement
Act
(
NTTAA)
of
1995
requires
Federal
agencies
to
evaluate
existing
technical
standards
when
developing
a
new
regulation.
To
comply
with
NTTAA,
EPA
must
consider
and
use
``
voluntary
consensus
standards''
(
VCS)
if
available
and
applicable
when
developing
programs
and
policies
unless
doing
so
would
be
inconsistent
with
applicable
law
or
otherwise
impractical.
EPA
believes
that
VCS
are
inapplicable
to
today's
proposed
action
because
it
does
not
require
the
public
to
perform
activities
conducive
to
the
use
of
VCS.
List
of
Subjects
in
40
CFR
Part
52
Environmental
protection,
Air
pollution
control,
Intergovernmental
relations,
Nitrogen
oxides,
Ozone,
Particulate
matter,
Reporting
and
recordkeeping
requirements.
Authority:
42
U.
S.
C.
7401
et
seq.
Dated:
October
29,
2002.
Alexis
Strauss,
Acting
Regional
Administrator,
Region
IX.
[
FR
Doc.
02
29477
Filed
11
19
02;
8:
45
am]
BILLING
CODE
6560
50
P
ENVIRONMENTAL
PROTECTION
AGENCY
40
CFR
Part
52
[
IN145
1b;
FRL
7398
6]
Approval
and
Promulgation
of
Implementation
Plans;
Indiana
AGENCY:
Environmental
Protection
Agency
(
EPA).
ACTION:
Proposed
rule.
SUMMARY:
The
EPA
is
proposing
to
approve
revisions
to
particulate
matter
(
PM)
emissions
regulations
for
Union
Tank
Car
of
Lake
County,
Indiana.
The
Indiana
Department
of
Environmental
Management
(
IDEM)
submitted
the
revised
regulations
on
April
30,
2002
and
September
6,
2002
as
an
amendment
to
its
State
Implementation
Plan
(
SIP).
The
revisions
consist
of
relaxing
the
PM
limits
for
one
emissions
unit;
however,
actual
emissions
will
not
increase,
and
the
PM
National
Ambient
Air
Quality
Standards
(
NAAQS)
should
be
protected.
EPA
is
approving
revisions
for
Union
Tank
Car
because
complying
with
the
current
limits
is
infeasible,
and
because
the
revisions
should
not
harm
air
quality.
DATES:
The
EPA
must
receive
written
comments
on
this
proposed
rule
by
December
20,
2002.
ADDRESSES:
You
should
mail
written
comments
to:
J.
Elmer
Bortzer,
Chief,
Regulation
Development
Section,
Air
Programs
Branch
(
AR
18J),
U.
S.
Environmental
Protection
Agency,
Region
5,
77
West
Jackson
Boulevard,
Chicago,
Illinois
60604.
You
may
inspect
copies
of
Indiana's
submittal
at:
Regulation
Development
Section,
Air
Programs
Branch
(
AR
18J),
U.
S.
Environmental
Protection
Agency,
Region
5,
77
West
Jackson
Boulevard,
Chicago,
Illinois
60604.
FOR
FURTHER
INFORMATION
CONTACT:
Matt
Rau,
Environmental
Engineer,
Regulation
Development
Section,
Air
Programs
Branch
(
AR
18J),
U.
S.
Environmental
Protection
Agency,
Region
5,
77
West
Jackson
Boulevard,
Chicago,
Illinois
60604,
Telephone
Number:
(
312)
886
6524,
E
Mail
Address:
rau.
matthew@
epa.
gov.
SUPPLEMENTARY
INFORMATION:
Table
of
Contents
I.
What
Action
Is
EPA
Taking
Today?
II.
Where
can
I
find
more
information
about
this
proposal
and
the
corresponding
direct
final
rule?
I.
What
Action
Is
EPA
Taking
Today?
The
EPA
is
proposing
to
approve
revisions
to
particulate
matter
emissions
regulations
for
Union
Tank
Car's
railcar
manufacturing
facility
in
Lake
County,
Indiana.
IDEM
submitted
the
revised
regulations
to
EPA
on
April
30,
2002
and
September
6,
2002
as
an
amendment
to
its
SIP.
The
revisions
consist
of
relaxing
the
limits
for
one
emissions
unit;
however,
actual
emissions
will
not
increase,
and
the
PM
NAAQS
should
be
protected.
EPA
is
proposing
approving
revisions
for
Union
Tank
Car
because
complying
with
the
current
limits
is
infeasible,
and
because
the
revisions
should
not
harm
air
quality.
II.
Where
Can
I
Find
More
Information
About
This
Proposal
and
the
Corresponding
Direct
Final
Rule?
For
additional
information
see
the
direct
final
rule
published
in
the
rules
section
of
this
Federal
Register.
Dated:
October
15,
2002.
David
A.
Ullrich,
Acting
Regional
Administrator,
Region
5.
[
FR
Doc.
02
29474
Filed
11
19
02;
8:
45
am]
BILLING
CODE
6560
50
P
ENVIRONMENTAL
PROTECTION
AGENCY
40
CFR
Part
180
[
OPP
2002
0280;
FRL
7278
3]
Pesticides;
Minimal
Risk
Tolerance
Exemptions
AGENCY:
Environmental
Protection
Agency
(
EPA).
ACTION:
Proposed
rule.
SUMMARY:
This
document
proposes
to
reorganize
certain
existing
tolerance
exemptions.
All
of
these
chemical
substances
were
reviewed
as
part
of
the
tolerance
reassessment
process
required
under
the
Food
Quality
Protection
Act
of
1996
(
FQPA).
As
a
result
of
that
review,
certain
chemical
substances
are
now
classified
as
``
minimal
risk,''
and
are
therefore
being
shifted
to
the
section
of
40
CFR
part
180
that
holds
minimal
risk
chemical
substances.
The
Agency
is
merely
moving
certain
tolerance
exemptions
from
one
section
of
the
CFR
to
another
section:
No
tolerance
exemptions
are
lost
as
a
result
of
this
action.
DATES:
Comments,
identified
by
docket
ID
number
OPP
2002
0280,
must
be
received
on
or
before
January
21,
2003.
ADDRESSES:
Comments
may
be
submitted
electronically,
by
mail,
or
through
hand
delivery/
courier.
Follow
the
detailed
instructions
as
provided
in
Unit
I.
of
the
SUPPLEMENTARY
INFORMATION.
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31>
2002
14:
03
Nov
19,
2002
Jkt
200001
PO
00000
Frm
00008
Fmt
4702
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4702
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FM\
20NOP1.
SGM
20NOP1
70037
Federal
Register
/
Vol.
67,
No.
224
/
Wednesday,
November
20,
2002
/
Proposed
Rules
FOR
FURTHER
INFORMATION
CONTACT:
Kathryn
Boyle,
Registration
Division
(
7505C),
Office
of
Pesticide
Programs,
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460
0001;
telephone
number:
(
703)
305
6304;
fax
number:
(
703)
305
0599;
e
mail
address:
boyle.
kathryn@
epa.
gov.
SUPPLEMENTARY
INFORMATION:
I.
General
Information
A.
Does
This
Action
Apply
to
Me?
You
may
be
potentially
affected
by
this
action
if
you
formulate
or
market
pesticide
products
or
if
you
market
certain
pesticides
that
have
been
exempted
from
the
Federal
Insecticide,
Fungicide,
and
Rodenticide
Act
(
FIFRA)
pursuant
to
section
25(
b)
of
FIFRA.
Potentially
affected
categories
and
entities
may
include,
but
are
not
limited
to:
Crop
production
(
NAICS
111)
Animal
production
(
NAICS
112)
Food
manufacturing
(
NAICS
311)
Pesticide
manufacturing
(
NAICS
32532)
Antimicrobial
pesticides
(
NAICS
32561)
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
0280.
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.
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.
Certain
types
of
information
will
not
be
placed
in
the
EPA
Dockets.
Information
claimed
as
CBI
and
other
information
whose
disclosure
is
restricted
by
statute,
which
is
not
included
in
the
official
public
docket,
will
not
be
available
for
public
viewing
in
EPA's
electronic
public
docket.
EPA's
policy
is
that
copyrighted
material
will
not
be
placed
in
EPA's
electronic
public
docket
but
will
be
available
only
in
printed,
paper
form
in
the
official
public
docket.
To
the
extent
feasible,
publicly
available
docket
materials
will
be
made
available
in
EPA's
electronic
public
docket.
When
a
document
is
selected
from
the
index
list
in
EPA
Dockets,
the
system
will
identify
whether
the
document
is
available
for
viewing
in
EPA's
electronic
public
docket.
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.
EPA
intends
to
work
towards
providing
electronic
access
to
all
of
the
publicly
available
docket
materials
through
EPA's
electronic
public
docket.
For
public
commenters,
it
is
important
to
note
that
EPA's
policy
is
that
public
comments,
whether
submitted
electronically
or
in
paper,
will
be
made
available
for
public
viewing
in
EPA's
electronic
public
docket
as
EPA
receives
them
and
without
change,
unless
the
comment
contains
copyrighted
material,
CBI,
or
other
information
whose
disclosure
is
restricted
by
statute.
When
EPA
identifies
a
comment
containing
copyrighted
material,
EPA
will
provide
a
reference
to
that
material
in
the
version
of
the
comment
that
is
placed
in
EPA's
electronic
public
docket.
The
entire
printed
comment,
including
the
copyrighted
material,
will
be
available
in
the
public
docket.
Public
comments
submitted
on
computer
disks
that
are
mailed
or
delivered
to
the
docket
will
be
transferred
to
EPA's
electronic
public
docket.
Public
comments
that
are
mailed
or
delivered
to
the
docket
will
be
scanned
and
placed
in
EPA's
electronic
public
docket.
Where
practical,
physical
objects
will
be
photographed,
and
the
photograph
will
be
placed
in
EPA's
electronic
public
docket
along
with
a
brief
description
written
by
the
docket
staff.
C.
How
and
To
Whom
Do
I
Submit
Comments?
You
may
submit
comments
electronically,
by
mail,
or
through
hand
delivery/
courier.
To
ensure
proper
receipt
by
EPA,
identify
the
appropriate
docket
ID
number
in
the
subject
line
on
the
first
page
of
your
comment.
Please
ensure
that
your
comments
are
submitted
within
the
specified
comment
period.
Comments
received
after
the
close
of
the
comment
period
will
be
marked
``
late.''
EPA
is
not
required
to
consider
these
late
comments.
If
you
wish
to
submit
CBI
or
information
that
is
otherwise
protected
by
statute,
please
follow
the
instructions
in
Unit
I.
D.
Do
not
use
EPA
Dockets
or
e
mail
to
submit
CBI
or
information
protected
by
statute.
1.
Electronically.
If
you
submit
an
electronic
comment
as
prescribed
in
this
unit,
EPA
recommends
that
you
include
your
name,
mailing
address,
and
an
email
address
or
other
contact
information
in
the
body
of
your
comment.
Also
include
this
contact
information
on
the
outside
of
any
disk
or
CD
ROM
you
submit,
and
in
any
cover
letter
accompanying
the
disk
or
CD
ROM.
This
ensures
that
you
can
be
identified
as
the
submitter
of
the
comment
and
allows
EPA
to
contact
you
in
case
EPA
cannot
read
your
comment
due
to
technical
difficulties
or
needs
further
information
on
the
substance
of
your
comment.
EPA's
policy
is
that
EPA
will
not
edit
your
comment,
and
any
identifying
or
contact
information
provided
in
the
body
of
a
comment
will
be
included
as
part
of
the
comment
that
is
placed
in
the
official
public
docket,
and
made
available
in
EPA's
electronic
public
docket.
If
EPA
cannot
read
your
comment
due
to
technical
difficulties
and
cannot
contact
you
for
clarification,
EPA
may
not
be
able
to
consider
your
comment.
i.
EPA
Dockets.
Your
use
of
EPA's
electronic
public
docket
to
submit
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Proposed
Rules
comments
to
EPA
electronically
is
EPA's
preferred
method
for
receiving
comments.
Go
directly
to
EPA
Dockets
at
http://
www.
epa.
gov/
edocket,
and
follow
the
online
instructions
for
submitting
comments.
Once
in
the
system,
select
``
search,''
and
then
key
in
docket
ID
number
OPP
2002
0280.
The
system
is
an
``
anonymous
access''
system,
which
means
EPA
will
not
know
your
identity,
e
mail
address,
or
other
contact
information
unless
you
provide
it
in
the
body
of
your
comment.
ii.
E
mail.
Comments
may
be
sent
by
e
mail
to
opp
docket@
epa.
gov,
Attention:
Docket
ID
Number
OPP
2002
0280.
In
contrast
to
EPA's
electronic
public
docket,
EPA's
e
mail
system
is
not
an
``
anonymous
access''
system.
If
you
send
an
e
mail
comment
directly
to
the
docket
without
going
through
EPA's
electronic
public
docket,
EPA's
e
mail
system
automatically
captures
your
e
mail
address.
E
mail
addresses
that
are
automatically
captured
by
EPA's
e
mail
system
are
included
as
part
of
the
comment
that
is
placed
in
the
official
public
docket,
and
made
available
in
EPA's
electronic
public
docket.
iii.
Disk
or
CD
ROM.
You
may
submit
comments
on
a
disk
or
CD
ROM
that
you
mail
to
the
mailing
address
identified
in
Unit
I.
C.
2.
These
electronic
submissions
will
be
accepted
in
WordPerfect
or
ASCII
file
format.
Avoid
the
use
of
special
characters
and
any
form
of
encryption.
2.
By
mail.
Send
your
comments
to:
Public
Information
and
Records
Integrity
Branch
(
PIRIB)
(
7502C),
Office
of
Pesticide
Programs
(
OPP),
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC,
20460
0001,
Attention:
Docket
ID
Number
OPP
2002
0280.
3.
By
hand
delivery
or
courier.
Deliver
your
comments
to:
Public
Information
and
Records
Integrity
Branch
(
PIRIB),
Office
of
Pesticide
Programs
(
OPP),
Environmental
Protection
Agency,
Rm.
119,
Crystal
Mall
#
2,
1921
Jefferson
Davis
Hwy.,
Arlington,
VA,
Attention:
Docket
ID
Number
OPP
2002
0280.
Such
deliveries
are
only
accepted
during
the
docket's
normal
hours
of
operation
as
identified
in
Unit
I.
A.
1.
D.
How
Should
I
Submit
CBI
to
the
Agency?
Do
not
submit
information
that
you
consider
to
be
CBI
electronically
through
EPA's
electronic
public
docket
or
by
e
mail.
You
may
claim
information
that
you
submit
to
EPA
as
CBI
by
marking
any
part
or
all
of
that
information
as
CBI
(
if
you
submit
CBI
on
disk
or
CD
ROM,
mark
the
outside
of
the
disk
or
CD
ROM
as
CBI
and
then
identify
electronically
within
the
disk
or
CD
ROM
the
specific
information
that
is
CBI).
Information
so
marked
will
not
be
disclosed
except
in
accordance
with
procedures
set
forth
in
40
CFR
part
2.
In
addition
to
one
complete
version
of
the
comment
that
includes
any
information
claimed
as
CBI,
a
copy
of
the
comment
that
does
not
contain
the
information
claimed
as
CBI
must
be
submitted
for
inclusion
in
the
public
docket
and
EPA's
electronic
public
docket.
If
you
submit
the
copy
that
does
not
contain
CBI
on
disk
or
CD
ROM,
mark
the
outside
of
the
disk
or
CD
ROM
clearly
that
it
does
not
contain
CBI.
Information
not
marked
as
CBI
will
be
included
in
the
public
docket
and
EPA's
electronic
public
docket
without
prior
notice.
If
you
have
any
questions
about
CBI
or
the
procedures
for
claiming
CBI,
please
consult
the
person
listed
under
FOR
FURTHER
INFORMATION
CONTACT.
E.
What
Should
I
Consider
as
I
Prepare
My
Comments
for
EPA?
You
may
find
the
following
suggestions
helpful
for
preparing
your
comments:
1.
Explain
your
views
as
clearly
as
possible.
2.
Describe
any
assumptions
that
you
used.
3.
Provide
any
technical
information
and/
or
data
you
used
that
support
your
views.
4.
If
you
estimate
potential
burden
or
costs,
explain
how
you
arrived
at
your
estimate.
5.
Provide
specific
examples
to
illustrate
your
concerns.
6.
Offer
alternatives.
7.
Make
sure
to
submit
your
comments
by
the
comment
period
deadline
identified.
8.
To
ensure
proper
receipt
by
EPA,
identify
the
appropriate
docket
ID
number
in
the
subject
line
on
the
first
page
of
your
response.
It
would
also
be
helpful
if
you
provided
the
name,
date,
and
Federal
Register
citation
related
to
your
comments.
II.
What
Action
is
the
Agency
Taking?
In
the
Federal
Register
published
on
May
24,
2002
(
67
FR
36534)
(
FRL
6834
8)
EPA
established
a
new
§
180.950
to
list
the
pesticide
chemical
substances
that
are
exempted
from
the
requirement
of
a
tolerance
based
on
the
Agency's
determination
that
these
chemical
substances
are
of
``
minimal
risk.''
As
the
first
step
in
populating
this
section,
the
Agency
shifted
the
existing
tolerance
exemptions
for
commonly
consumed
food
commodities,
animal
feed
items,
and
edible
fats
and
oils
to
this
section.
This
proposed
rule
shifts
existing
tolerance
exemptions
for
certain
inert
ingredients
that
have
been
classified
by
the
Agency
as
List
4A,
``
minimal
risk,''
to
40
CFR
180.950.
The
decision
documents
supporting
the
minimal
risk,
List
4A
Classification,
are
in
the
docket.
The
following
tolerance
exemptions
are
being
shifted
from
40
CFR
180.2:
Citric
acid,
fumaric
acid,
lime,
sodium
chloride,
and
sulfur.
The
following
tolerance
exemptions
are
being
shifted
from
40
CFR
180.1001(
c):
Animal
glue;
bentonite;
calcareous
shale;
calcite;
calcium
carbonate;
calcium
citrate;
calcium
silicate;
a
cellulose;
citric
acid;
coffee
grounds;
corn
dextrin;
dextrin;
dolomite;
graphite;
guar
gum;
gypsum;
hydroxyethyl
cellulose;
hydroxypropyl
methylcellulose;
iron
oxide;
kaolinitetype
clay;
lecithin;
licorice
root;
magnesium
carbonate;
magnesium
lime;
magnesium
oxide;
magnesium
silicate;
magnesium
sulfate;
methylcellulose;
mica;
montmorillonite
type
clay;
potassium
aluminum
silicate;
potassium
chloride;
potassium
citrate;
potassium
sulfate;
silica,
hydrated;
silicon
dioxide,
fumed,
amorphous;
sodium
acetate;
sodium
alginate;
sodium
aluminum
silicate;
sodium
bicarbonate;
sodium
carboxymethylcellulose;
sodium
chloride;
sodium
sulfate;
vermiculite;
xanthan
gum;
zeolite
(
hydrated
alkali
aluminum
silicate);
and
zinc
oxide.
The
following
tolerance
exemptions
are
being
shifted
from
40
CFR
180.1001(
d):
Cellulose
acetate;
graphite;
hydroxypropylcellulose;
locust
bean
gum;
paper
fiber,
deinked
or
recycled;
paper
fiber,
produced
by
the
kraft
(
sulfate)
or
sulfite
pulping
processes;
silicon
dioxide,
fumed,
amorphous;
soap
bark
(
quillaja);
sodium
citrate;
and
wool
fat
(
anhydrous
lanolin).
The
following
tolerance
exemptions
are
being
shifted
from
40
CFR
180.1001(
e):
Calcium
carbonate;
calcium
silicate
(
hydrated
calcium
silicate);
calcium
sulfate;
castor
oil,
u.
s.
p.;
a
cellulose;
citric
acid;
dextrin;
graphite;
iron
oxide;
kaolinite
type
clay;
magnesium
carbonate;
methylcellulose;
montmorillonite
type
clay;
potassium
citrate;
silica,
amorphous,
fumed
(
crystalline
free);
silica,
hydrated
silica;
silica
aerogel;
sodium
carboxymethylcellulose,
sodium
sulfate;
sulfur;
xanthan
gum;
and
zinc
oxide.
The
following
tolerance
exemptions
are
also
being
shifted
from:
§
180.1036:
Hydrogenated
castor
oil,
§
180.1176:
Sodium
bicarbonate,
§
180.1177:
Potassium
bicarbonate,
and
§
180.1180:
Kaolin.
Because
this
action
merely
moves
certain
tolerance
exemptions
from
one
section
of
the
CFR
to
another
section,
it
will
have
no
substantive
or
procedural
effect
on
the
moved
tolerance
exemptions.
No
tolerance
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2002
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Proposed
Rules
exemptions
are
lost
as
a
result
of
this
action.
III.
What
is
the
Agency's
Authority
for
Taking
this
Action?
This
proposed
rule
is
issued
under
section
408
of
the
Federal
Food,
Drug,
and
Cosmetic
Act
(
FFDCA),
21
U.
S.
C.
346a,
as
amended
by
the
FQPA
(
Public
Law
104
170).
Section
408(
e)
of
FFDCA
authorizes
EPA
to
establish,
modify,
or
revoke
tolerances,
or
exemptions
from
the
requirement
of
a
tolerance
for
residues
of
pesticide
chemical
substances
in
or
on
raw
agricultural
commodities
and
processed
foods.
IV.
What
is
``
Minimal
Risk?''
The
term
``
minimal
risk''
has
been
used
by
EPA
for
over
10
years,
and
has
generally
meant
List
4A
inert
ingredient
chemical
substances.
On
April
22,
1987
(
52
FR
13305),
EPA
created
a
series
of
four
lists
as
part
of
an
initiative
to
address
the
risks
potentially
posed
by
inert
ingredients
in
pesticide
products.
At
that
time
all
List
4
inert
ingredients
were
classified
as
``
inerts
of
minimal
concern.''
The
4A
Inert
Ingredient
List
was
created
on
November
22,
1989
(
54
FR
48314)
by
subdividing
List
4
into
Lists
4A
and
4B.
List
4B
inert
ingredients
are
``
inerts
for
which
EPA
has
sufficient
information
to
reasonably
conclude
that
the
current
use
pattern
in
pesticide
products
will
not
adversely
affect
public
health
or
the
environment.''
List
4A
inert
ingredients
are
``
minimal
risk
inert
ingredients.''
Only
substances
on
List
4A
are
permitted
to
be
used
as
inert
ingredients
in
certain
pesticides
that
have
been
exempted
from
FIFRA,
7
U.
S.
C.
136
et
seq.,
pursuant
to
section
25(
b)
of
FIFRA,
7
U.
S.
C.
136w(
b).
Minimal
risk
does
not
imply
no
risk
under
any
circumstances.
Every
substance
can
present
some
risk
in
certain
circumstances.
Minimal
risk
is
used
to
indicate
a
substance
for
which
there
is
no
information
to
indicate
that
there
is
a
basis
for
concern.
Many
minimal
risk
or
List
4A
substances
are
naturally
occurring
substances
to
which
some
refinement
has
occurred,
such
as
beeswax,
limestone,
red
cedar
chips,
salt,
and
sugar.
The
determination
that
a
chemical
substance
is
minimal
risk
would
be
based
on
a
recognition
of
the
overall
safety
of
the
chemical
(
such
as
very
low
toxicity
or
practically
nontoxic
considering
the
widely
available
information
on
the
chemical
substances
known
properties,
and
a
history
of
safe
use
under
reasonable
circumstances.
Minimal
risk
(
List
4A)
chemical
substances
are
recognized
as
safe
for
use
in
all
pesticide
products
subject
only
to
good
agricultural
practices
or
good
manufacturing
practices.
Classification
as
a
List
4A,
minimal
risk,
chemical
substance
is
a
high
standard
to
meet.
As
an
example,
chemical
substances
of
high
acute
toxicity
are
usually
not
considered
for
classification
to
List
4A.
The
critical
distinction
between
List
4A
minimal
risk
chemical
substances
and
other
chemical
substances,
is
that
the
Agency
does
not
define
how,
where,
when
or
in
what
manner
the
chemical
substance
can
be
used.
Any
reasonably
foreseeable
use
of
these
chemical
substances
in
a
pesticide
product
is
not
expected
to
present
a
risk
to
humans.
Accordingly,
there
should
not
be
any
unreasonable
adverse
effects
from
the
inclusion
of
a
List
4A
chemical
substance
in
a
pesticide
product
to
the
person
applying
a
pesticide
product
in
and
around
their
home,
to
a
child
in
a
daycare
center,
or
when
ingesting
a
food
commodity
that
has
been
treated.
A
List
4A
chemical
substance
used
as
an
inert
ingredient,
incorporated
into
a
25(
b)
product
(
meeting
all
the
appropriate
exemption
criteria)
is
subject
to
no
Federal
regulation
under
FIFRA
except
as
provided
in
40
CFR
152.25(
g).
The
Agency
must
give
consideration
to
all
routes
of
exposure
to
determine
that
a
chemical
substance
used
in
a
pesticide
product
can
be
classified
as
minimal
risk.
Several
of
the
chemical
substances
being
shifted
to
the
new
section
are
naturally
occurring
materials
that
have
been
referred
to
as
weathered
materials.
Weathered
materials
is
the
term
that
the
Agency
is
using
to
describe
a
group
of
substances
that
could
also
be
referred
to
as
rocks
and
minerals.
Generally,
weathered
materials
are
decayed
or
weathered
rocks
that
are
mostly
unrefined,
i.
e.,
not
altered
or
manufactured
by
man.
When
referring
to
weathered
materials
as
mostly
unrefined,
the
Agency
is
including
the
mechanical
grinding
of
larger
rocks
into
smaller
pieces
that
are
essentially
the
same,
but
not
the
chemical
or
physical
alteration
of
the
rock
into
a
different
substance.
Naturally
occurring
materials
such
as
these
can
contain
impurities
such
as
asbestos
or
silica
which
can
lead
to
health
effects
including
pneumoconiosis,
silicosis,
or
kaolinosis.
To
evaluate
these
effects,
the
Agency
conducted
a
screening
level
assessment
on
weathered
materials
that
compared
an
estimated
residential
exposure
to
the
OSHA
threshold
limit
value
(
TLV).
A
TLV
is
a
limit
on
inhalation
exposure
in
the
workplace.
Only
those
chemical
substances
that
passed
this
screening
level
assessment
were
considered
for
List
4A
status.
V.
Nomenclature
Changes
For
some
of
the
chemical
substances
that
are
being
shifted
to
40
CFR
180.950,
EPA
is
making
minor
changes
to
the
chemical
substance
names
that
were
previously
used.
Additionally,
the
Agency
has
attempted
to
identify
each
of
the
listed
chemical
substances
using
the
Chemical
Abstracts
Service
Registry
Number
(
CAS
No.).
The
CAS
No.
provides
one
of
the
most
distinct
and
universally
accepted
means
of
identifying
chemical
substances.
The
lack
of
a
CAS
No.
will
not
preclude
the
Agency
from
including
substances
in
40
CFR
180.950.
Generally,
there
will
be
only
one
CAS
No.
per
listed
substance;
however,
it
is
possible
that
more
than
one
CAS
No.
may
be
appropriate
for
some
substances,
such
as
when
there
is
both
a
hydrated
and
anhydrous
form.
EPA
has
both
broadened
and
consolidated
names
to
account
for
differing
terminologies
and
current
usage
status.
Also,
additional
information
to
better
define
the
impurities
in
some
naturally
occurring
substances
and
thus
limit
the
inhalation
concerns
that
can
occur
with
naturallyoccurring
materials
in
a
respirable
form
may
have
been
added.
VI.
Issues
for
Future
Agency
Actions
A.
Chemical
Substances
Being
Transferred
From
List
4A
to
List
4B
The
proposed
rule
published
in
the
Federal
Register
of
January
15,
2002
(
67
FR
1925)
(
FRL
6807
8)
indicated
that
several
allergen
containing
food
commodities
would
be
moved
from
List
4A
to
List
4B.
The
Agency
has
now
determined
that
there
are
additional
chemical
substances
that
no
longer
meet
the
criteria
of
List
4A.
These
chemical
substances
are
acetic
acid,
activated
charcoal,
attapulgite
clay,
gum
arabic,
and
granite.
These
chemical
substances
will
be
transferred
from
the
Agency's
4A
list
to
the
4B
list.
Pesticide
products
containing
these
inert
ingredients
will
no
longer
be
considered
exempt
under
FIFRA
section
25(
b)
once
that
transfer
is
made.
Manufacturers
of
such
products
will
have
the
option
of
either
reformulating
their
product,
substituting
a
different
List
4A
inert
ingredient,
or
of
registering
the
product
with
the
Agency.
It
is
noted
that
vinegar
(
maximum
of
8%
acetic
acid
in
solution),
a
commonly
consumed
food
commodity,
is
still
classified
as
List
4A.
B.
Chemical
Substances
That
Have
Been
Classified
as
List
4A
The
Agency
has
classified
more
chemical
substances
as
List
4A,
and
is
likely
to
classify
additional
chemical
substances
as
List
4A.
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/
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67,
No.
224
/
Wednesday,
November
20,
2002
/
Proposed
Rules
existing
tolerance
exemptions
for
all
of
these
chemical
substances
to
40
CFR
180.950
is
a
multi
step
process
that
will
continue.
Additionally,
on
its
own
initiative,
the
Agency
will
propose
to
establish
tolerance
exemptions
in
40
CFR
180.950
for
some
chemical
substances
that
are
currently
classified
as
List
4A,
but
do
not
have
tolerance
exemptions.
At
the
conclusion
of
this
multi
step
process,
all
chemical
substances
classified
as
List
4A
will
be
included
in
40
CFR
180.950
and
will
thus
have
tolerance
exemptions.
VII.
Regulatory
Assessment
Requirements
This
proposed
rule
merely
reorganizes
existing
exemptions
in
40
CFR
part
180.
This
has
no
substantive
effect
and
hence
causes
no
impact.
The
Agency
is
acting
on
its
own
initiative
under
FFDCA
section
408
(
e)
in
shifting
these
existing
tolerance
exemptions
to
a
new
section.
Under
Executive
Order
12866,
entitled
Regulatory
Planning
and
Review
(
58
FR
51735,
October
4,
1993),
this
action
is
not
a
``
significant
regulatory
action''
subject
to
review
by
the
Office
of
Management
and
Budget
(
OMB).
Because
the
proposed
rule
has
been
exempted
from
review
under
Executive
Order
12866
due
to
its
lack
of
significance,
this
proposed
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
proposed
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
require
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).
Pursuant
to
section
605(
b)
of
the
Regulatory
Flexibility
Act
(
RFA)
(
5
U.
S.
C.
601
et
seq.),
the
Agency
hereby
certifies
that
these
proposed
actions
will
not
have
significant
negative
economic
impact
on
a
substantial
number
of
small
entities.
As
noted
in
this
unit,
this
action
will
have
no
substantive
or
procedural
effect
on
the
tolerance
exemptions
affected.
However,
by
grouping
tolerance
exemptions
that
have
qualified
as
minimal
risk
inerts
in
one
location
in
the
CFR,
this
action
will
make
it
easier
for
small
entities
to
efficiently
use
EPA's
tolerance
regulations.
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
proposed
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
FFDCA
section
408(
n)(
4).
For
these
same
reasons,
the
Agency
has
determined
that
this
proposed
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
proposed
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
proposed
rule.
List
of
Subjects
in
40
CFR
Part
180
Environmental
protection,
Administrative
practice
and
procedure,
Pesticides
and
pests,
Reporting
and
recordkeeping
requirements.
Dated:
October
27,
2002.
Debra
Edwards,
Acting
Director,
Registration
Division,
Office
of
Pesticide
Programs.
Therefore,
it
is
proposed
that
40
CFR
chapter
I
be
amended
as
follows:
PART
180
[
AMENDED]
1.
The
authority
citation
for
part
180
would
continue
to
read
as
follows:
Authority:
21
U.
S.
C.
321(
q),
346(
a)
and
374.
§
180.2
[
Amended]
2.
In
§
180.2,
paragraph
(
a),
is
amended
by
removing
``
citric
acid,''
``
fumaric
acid,''
``
lime,''
``
sodium
chloride,''
and
``
sulfur.''
3.
In
§
180.950,
paragraph
(
e)
is
amended
by
alphabetically
adding
the
following
chemical
substances
to
read
as
follows:
§
180.950
Tolerance
exemptions
for
minimal
risk
active
and
inert
ingredients.
*
*
*
*
*
(
e)
*
*
*
Chemical
substances
CAS
No.
Acetic
acid,
sodium
salt
.....................
127
09
3
Animal
glue
...........
None
Bentonite
...............
1302
78
9
Bentonite,
sodian
..
85049
30
5
Calcium
oxide
silicate
(
Ca3O(
SiO4))
.....
12168
85
3
Carbonic
acid,
calcium
salt,
(
limestone)
(
marble)
(
chalk)
(
mollusc/
bivalve
shells)
(
no
asbestos
and
less
than
1%
crystalline
silica)
......
1317
65
3
Carbonic
acid,
calcium
salt
(
calcite)
(
no
asbestos
and
less
than
1%
crystalline
silica)
......
13397
26
7
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224
/
Wednesday,
November
20,
2002
/
Proposed
Rules
Chemical
substances
CAS
No.
Carbonic
acid,
calcium
salt
(
1:
1),
(
no
asbestos
and
less
than
1%
crystalline
silica)
.................
471
34
1
Carbonic
acid,
calcium
salt
(
1:
1),
hexahydrate
......
15634
14
7
Carbonic
acid,
magnesium
salt
(
1:
1)
(
less
than
1%
crystalline
silica)
.................
546
93
0
Carbonic
acid,
monopotassium
salt
.....................
298
14
6
Carbonic
acid,
monosodium
salt
144
55
8
Carob
gum
(
locust
bean
gum)
.........
9000
40
2
Castor
oil
..............
8001
79
4
Castor
oil,
hydrogenated
.............
8001
78
3
Cellulose
...............
9004
34
6
Cellulose
acetate
..
9004
35
7
Cellulose,
carboxy
methyl
ether,
sodium
salt
............
9004
32
4
Cellulose,
2
hydroxyethyl
ether
9004
62
0
Cellulose,
2
hydroxypropyl
ether
..................
9004
64
2
Cellulose,
2
hydroxypropyl
methyl
ester
......
9004
65
3
Cellulose,
methyl
ether
..................
9004
67
5
Cellulose,
mixture
with
cellulose
carboxymethyl
ether,
sodium
salt
.....................
51395
75
6
Cellulose,
pulp
......
65996
61
4
Cellulose,
regenerated
................
68442
85
3
Citric
acid
..............
77
92
9
Citric
acid,
calcium
salt
.....................
7693
13
2
Citric
acid,
calcium
salt
(
2:
3)
............
813
94
5
Citric
acid,
dipotassium
salt
3609
96
9
Citric
acid,
disodium
salt
............
144
33
2
Citric
acid,
monohydrate
.....
5949
29
1
Citric
acid,
monopotassium
salt
.....................
866
83
1
Citric
acid,
monosodium
salt
........
18996
35
5
Citric
acid,
potassium
salt
............
7778
49
6
Citric
acid,
sodium
salt
.....................
994
36
5
Citric
acid,
tripotassium
salt
866
84
2
Citric
acid,
tripotassium
salt
monohydrate
.....
6100
05
6
Chemical
substances
CAS
No.
Citric
acid,
trisodium
salt
........
68
04
2
Citric
acid,
trisodium
salt,
dihydrate
..............
6132
04
3
Citric
acid,
trisodium
salt,
pentahydrate
.....
6858
44
2
Coffee
grounds
.....
68916
18
7
Dextrins
.................
9004
53
9
Dolomite
(
CaMg(
CO3)
2)
(
no
asbestos
and
less
than
1%
crystalline
silica)
.................
16389
88
1
Feldspar
group
minerals
(
no
asbestos
and
less
than
1%
crystalline
silica)
......
68476
25
5
Fuller's
earth
.........
8031
18
3
Fumaric
acid
.........
110
17
8
Graphite
(
no
asbestos
and
less
than
1%
crystalline
silica)
......
7782
42
5
Guar
gum
..............
9000
30
0
Gypsum
(
sulfuric
acid,
calcium
salt,
dihydrate)
(
no
asbestos
and
less
than
1%
crystalline
silica)
.................
13397
24
5
Iron
oxide
(
FeO)
...
1345
25
1
Iron
oxide
(
Fe2O3)
1309
37
1
Iron
oxide
(
Fe2O3),
hydrate
..............
12259
21
1
Iron
oxide
(
Fe3O4)
1317
61
9
Kaolin
(
no
asbestos
and
less
than
1%
crystalline
silica)
.................
1332
58
7
*
*
*
*
*
Lanolin
..................
8006
54
0
Lecithins
................
8002
43
5
Lecithins,
soya
......
8030
76
0
Licorice
Extract
.....
68916
91
6
Lime
(
chemical)
dolomitic
(
magnesium
and
calcium
carbonate
(
magnesiumlime
..................
12001
27
3
Magnesium
oxide
1309
48
4
Magnesium
silicon
oxide
(
Mg2Si3O8)
14987
04
3
Maltodextrin
..........
9050
36
6
Mica
group
minerals
(
no
asbestos
and
less
than
1%
crystalline
silica)
.................
12001
26
2
Montmorillonite
.....
1318
93
0
Paper
....................
None
Perlite
(
no
asbestos
and
less
than
1%
crystalline
silica)
.................
130885
09
5
Chemical
substances
CAS
No.
Perlite,
expanded
(
no
asbestos
and
less
than
1%
crystalline
silica)
.................
93763
70
3
Plaster
of
Paris
(
sulfuric
acid,
calcium
salt,
hemihydrate);
(
no
asbestos
and
less
than
1%
crystalline
silica)
.................
26499
65
0
Potassium
chloride
7447
40
7
Silica
aerogel
........
Silica,
amorphous,
diatomaceous
earth
(
Kieselguhr)(
less
than1%
crystalline
silica)
......
61790
53
2
Silica,
amorphous,
fumed
(
crystalline
free)
112945
52
5
Silica,
amorphous,
perlite,
...............
Silica,
amorphous,
precipitated
and
gel
.....................
7699
41
4
Silica
(
crystallinefree
forms
only)
7631
86
9
Silica
gel
...............
63231
67
4
Silica
gel,
precipitated
crystalline
free
.........
112926
00
8
Silica,
hydrate
.......
10279
57
9
Silica,
vitreous
......
60676
86
0
Silicic
acid,
aluminum
potassium
salt
............
1327
44
2
Silicic
acid,
aluminum
salt
.........
1327
36
2
Silicic
acid,
aluminum
salt,
hydrate
..................
1335
30
4
Silicic
acid,
aluminum
sodium
salt
(
1:
1:
1)
.........
12003
51
9
Silicic
acid,
aluminum
sodium
salt
.....................
1344
00
9
Silicic
acid,
calcium
salt
.....................
1344
95
2
Silicic
acid,
calcium
salt,
(
wollastonite)
(
no
asbestos
and
less
than
1%
crystalline
silica)
13983
17
0
Silicic
acid,
magnesium
salt
............
1343
88
0
Silicic
acid,
magnesium
salt,
hydrate
..................
1343
90
4
Silicic
acid,
magnesium
salt
(
1:
1)
...
13776
74
4
Soapbark
(
Quillaja
saponin)
............
1393
03
9
Sodium
alginate
....
9005
38
3
Sodium
chloride
(
table
salt)
.........
7647
14
5
Sulfur
....................
7704
34
9
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Federal
Register
/
Vol.
67,
No.
224
/
Wednesday,
November
20,
2002
/
Proposed
Rules
Chemical
substances
CAS
No.
Sulfuric
acid,
calcium
salt
(
1:
1)
...
7778
18
9
Sulfuric
acid,
calcium
salt,
dihydrate
(
1:
1)
.........
10101
41
4
Sulfuric
acid,
calcium
salt,
hydrate
(
2:
2:
1)
......
10034
76
1
Sulfuric
acid,
magnesium
salt,
(
1:
1)
...................
7487
88
9
Sulfuric
acid,
magnesium
salt
(
1:
1)
heptahydrate
.....
10034
99
8
Sulfuric
acid,
magnesium
salt
(
1:
1)
monohydrate
.....
14168
73
1
Sulfuric
acid,
monopotassium
salt
.....................
7646
93
7
Sulfuric
acid,
dipotassium
salt
7778
80
5
Sulfuric
acid,
disodium
salt
............
7757
82
6
Sulfuric
acid,
disodium
salt,
decahydrate
..............
7727
73
3
Sulfuric
acid,
disodium
salt,
heptadydrate
.....
13472
39
4
Vermiculite
(
no
asbestos
and
less
than
1%
crystalline
silica)
......
1318
00
9
Xanthan
gum
........
11138
66
2
Zeolites
(
excluding
erionite;
CAS
No.
12510
42
8)
.......................
1318
02
1
Zinc
oxide
.............
1314
13
2
§
180.1001
[
Amended]
4.
In
§
180.1001
the
table
in
paragraph
(
c)
is
amended
by
removing
the
following
entries:
``
Animal
glue;''
``
Bentonite;''
``
Calcareous
shale;''
``
Calcite;''
``
Calcium
carbonate;''
``
Calcium
citrate;''
``
Calcium
silicate;''
``
a
Cellulose;''
``
Citric
acid;''
``
Coffee
grounds;''
``
Corn
dextrin;''
``
Dextrin;''
``
Dolomite;''
``
Graphite;''
``
Guar
gum;''
``
Gypsum;''
``
Hydroxyethyl
cellulose;''
``
Hydroxypropyl
methylcellulose;''
``
Iron
oxide;''
``
Kaolinite
type
clay;''
``
Lecithin;''
``
Licorice
root;''
``
Magnesium
carbonate;''
``
Magnesiumlime
``
Magnesium
oxide;''
``
Magnesium
silicate;''
``
Magnesium
sulfate;''
``
Methylcellulose;''
``
Mica;''
``
Montmorillonite
type
clay;''
``
Potassium
aluminum
silicate;''
``
Potassium
chloride;''
``
Potassium
citrate;''
``
Potassium
sulfate;''
``
Silica,
hydrated;''
``
Silicon
dioxide,
fumed,
amorphous;''
``
Sodium
acetate;
``
Sodium
alginate;''
``
Sodium
aluminum
silicate;''
``
Sodium
bicarbonate;''
``
Sodium
carboxymethylcellulose;''
``
Sodium
chloride;''
``
Sodium
sulfate;''
``
Vermiculite;''
``
Xanthan
Gum;''
``
Zeolite
(
hydrated
alkali
aluminum
silicate;''
``
Zinc
oxide.''
5.
In
§
180.1001
the
table
in
paragraph
(
d)
is
amended
by
removing
the
following
inert
ingredients:
``
Cellulose
acetate
(
CAS
Reg.
No.
9004
35
7),
minimum
number
average
molecular
weight,
28,000;
``
Graphite;''
``
Hydroxypropyl
cellulose;''
``
Locust
bean
gum;''
``
Paper
fiber,
deinked
or
recycled,
conforming
to
21
CFR
109.30(
a)(
9)
and
21
CFR
176.260;''
``
Paper
fiber,
produced
by
the
kraft
(
sulfate)
or
sulfite
pulping
processes;''
``
Silicon
dioxide,
fumed,
amorphous;''
``
Soap
bark
(
quillaja);''
``
Sodium
citrate;''
``
Wool
fat
(
anhydrous
lanolin).''
6.
In
§
180.1001
the
table
in
paragraph
(
e)
is
amended
by
removing
the
following
inert
ingredients:
``
Calcium
carbonate;''
Calcium
silicate
(
hydrated
calcium
silicate);''
Calcium
sulfate;''
``
Castor
oil,
U.
S.
P.;''
``
a
Cellulose;''
``
Citric
acid;''
``
Dextrin
(
CAS
Reg.
No.
9004
53
9);''
``
Graphite;''
``
Iron
Oxide
(
CAS
Reg.
No.
1309
37
1);''
``
Kaolinitetype
clay;''
``
Magnesium
carbonate;''
``
Methylcellulose;''
``
Montmorillonitetype
clay;''
``
Potassium
citrate
(
CAS
Reg.
No.
866
84
2);''
``
Silica,
amorphous,
fumed
(
crystalline
free)
(
CAS
Reg.
No.
112945
52
5);''
``
Silica,
hydrated
silica,;''
``
Silica
aerogel
(
finely
powdered
microcellular
silica
foam
having
a
minimum
silica
content
of
89.5%);''
``
Sodium
carboxymethylcellulose;''
``
Sodium
sulfate;''
``
Sulfur
(
CAS
Reg.
No.
7704
34
9);''
``
Xanthan
gum;''
``
Zinc
oxide.''
§
180.1036
[
Removed]
7.
Section
180.1036
is
removed.
§
180.1176
[
Removed]
8.
Section
180.1176
is
removed.
§
180.1177
[
Removed]
9.
Section
180.1177
is
removed.
§
180.1180
[
Removed]
10.
Section
180.1180
is
removed.
[
FR
Doc.
02
29172
Filed
11
19
02;
8:
45
am]
BILLING
CODE
6560
50
S
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E:\
FR\
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20NOP1.
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20NOP1
| epa | 2024-06-07T20:31:44.078986 | regulations | {
"license": "Public Domain",
"url": "https://downloads.regulations.gov/EPA-HQ-OPP-2002-0280-0001/content.txt"
} |