Document ID: EPA-HQ-OPP-2005-0293-0007
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2005-12-28T05:00Z

.

UNITED
STATES
ENVIRONMENTAL
PROTECTION
AGENCY
WASHINGTON,
D.
C.
20460
OFFICE
OF
PREVENTION,
PESTICIDES
AND
TOXIC
SUBSTANCES
05­
MAR­
2004
MEMORANDUM
SUBJECT:
Cypermethrin.
HED
Response
to
Error­
Only
Registrant
Comments
on
the
Cypermethrin
Preliminary
RED
and
Supporting
Documents,
PC
Code
109702;
DP
Barcode
D298690.

From:
William
H.
Donovan,
Ph.
D.,
Chemist
Pamela
M.
Hurley,
Ph.
D.,
Toxicologist
Reregistration
Branch
3
Health
Effects
Division
[
7509C]

Through:
Catherine
Eiden,
Branch
Chief
Reregistration
Branch
3
Health
Effects
Division
[
7509C]

To:
Mark
Seaton,
Chemical
Review
Manager
Reregistration
Branch
2
Special
Review
and
Reregistration
Division
[
7508C]

FMC
Corporation,
Syngenta,
and
United
Phosphorus,
Inc.
have
provided
error­
only
comments
for
the
cypermethrin
preliminary
RED
and
supporting
documents
(
HIARC
report,
dietary
exposure
analysis,
and
ORE
chapter).
Many
of
the
comments
concern
the
omission
of
zetacypermethrin
from
the
ORE
chapter
and
risk
assessment
document.
HED
concurs
that
zetacypermethrin
should
be
included
for
the
residential
exposure
assessment.
However,
revision
of
the
ORE
chapter,
the
short­
and
intermediate­
term
aggregate
risk
tables,
and
overall
risk
assessment
document
to
include
zeta­
cypermethrin
will
require
significant
effort
and
thus
will
be
forthcoming
in
a
separate
document.
For
the
purposes
of
the
present
memo,
HED
will
provide
updated
acute
and
chronic
DWLOC
tables,
and
a
point­
by­
point
response
to
each
comment
concerning
the
dietary
exposure
analysis
and
the
HIARC
report.
.
HED
responses
to
comments
on
the
dietary
exposure
analysis
for
cypermethrin
and
zetacypermethrin

1.
Spelling
corrections
and
isomer
concentrations
will
be
added.

2.
Section
II
 
Residue
information,
first
paragraph,
last
sentence.
This
sentence
will
be
modified
to
read
as
follows:
"
For
crops
registered
for
use
with
both
cypermethrin
and
zeta­
cypermethrin,
no
attempt
was
made
to
combine
residues
from
separate
treatments
because
of
label
restrictions
that
limit
the
maximum
seasonal
total
of
cypermethrin
plus
zeta­
cypermethrin
to
equal
the
maximum
seasonal
total
for
cypermethrin
use
alone."

3.
Attachment
1.
Point
of
clarification
noted.
However,
since
the
analysis
made
use
of
the
highest
%
CT
value
from
either
cypermethrin
or
zeta­
cypermethrin
data,
no
impact
on
the
analysis
results.

4.
Section
II
 
Table
1.
The
processing
factors
for
tomato
paste
and
puree
will
be
corrected
as
requested.

5.
Section
II
 
Table
3.
Acute
and
chronic
anticipated
dietary
burdens
of
cypermethrin
and
zetacypermethrin
from
feed
commodities.
A.
Alfalfa
hay.
Data
from
the
zeta­
cypermethrin
alfalfa
field
trials
are
now
included
in
the
determination
of
the
maximum
and
average
alfalfa
hay
residue
levels
used
in
the
dietary
burden
computation.
To
account
for
the
different
use
rates
in
the
cypermethrin
and
zeta­
cypermethrin
field
trials,
all
cypermethrin
residue
levels
were
divided
by
a
factor
of
two
while
the
zetacypermethrin
data
were
used
directly.
Inclusion
of
the
6
zeta­
cypermethrin
field
trials
results
in
an
increase
in
the
maximum
residue
level
from
16.4
to
18.3
ppm
and
an
increase
in
the
average
residue
level
from
7.25
to
7.68
ppm.
B.
Sweet
corn
forage.
Data
from
the
cypermethrin
sweet
corn
field
trials
are
now
included
in
the
determination
of
the
maximum
and
average
sweet
corn
forage
residue
levels
used
in
the
dietary
burden
computation.
To
account
for
the
different
use
rates
in
the
cypermethrin
and
zetacypermethrin
field
trials,
all
cypermethrin
residue
levels
were
divided
by
a
factor
of
two
while
the
zeta­
cypermethrin
data
were
used
directly.
Inclusion
of
the
10
cypermethrin
field
trials
results
in
no
change
for
the
maximum
residue
level
and
an
increase
in
the
average
residue
level
from
2.93
to
3.34
ppm.
C.
As
a
result
of
the
changes
from
5A
and
5B
above,
the
acute
anticipated
dietary
burden
for
beef
and
dairy
cattle
has
increased
from
15.1
to
15.6
ppm,
while
the
chronic
anticipated
dietary
burden
for
beef
and
dairy
cattle
has
increased
from
4.72
to
5.18
ppm.

6.
Section
II
 
Table
4.
Range
of
cypermethrin
residues
(
ppm)
found
in
cow
milk
and
tissue
samples.
A.
This
table
provides
the
maximum
residue
levels
(
for
use
in
acute
analysis)
and
average
residue
levels
(
for
use
in
chronic
analysis).
B.
Residue
levels
for
whole
milk
were
taken
from
MRID
432780­
02.

7.
Section
II
 
Table
5.
Acute
anticipated
residues
in
cattle.
.

3
The
updated
anticipated
dietary
burden
level
discussed
in
5A
above
has
been
incorporated
into
Table
5
along
with
the
recalculated
acute
anticipated
residue
levels
for
cattle
commodities.

8.
Section
II
 
Table
6.
Chronic
anticipated
residues
in
cattle.
A.
The
updated
anticipated
dietary
burden
level
discussed
in
5C
above
has
been
incorporated
into
Table
6
along
with
the
recalculated
chronic
anticipated
residue
levels
for
cattle
commodities.
B.
No
reason
was
provided
to
support
the
request
to
change
the
muscle
and
kidney
Residue
in
Tissue
levels
to
0.009
ppm.
However,
to
alleviate
concerns
the
registrants
may
have
about
using
residue
data
measured
at
the
5
ppm
dosing
level,
HED
will
instead
use
the
residue
data
from
the
15
ppm
dosing
level
for
muscle
and
kidney.
This
change
will
also
be
made
for
swine
in
Table
13.

9.
Section
II
 
Table
9.
Cypermethrin
Levels
in
Poultry
Tissue
and
Eggs.
A.
HED
concurs
that
the
average
fat
value
for
the
2
ppm
dose
is
<
0.010
ppm,
and
this
change
will
be
made.
B.
The
capitalized
footnotes
will
be
changed
to
lower
case
letters.
Also,
the
footnote
superscript
will
be
changed
from
"
3"
to
"
c".

10.
Section
II
 
Table
11.
Chronic
anticipated
residues
in
poultry.
To
alleviate
concerns
about
the
poultry
fat
residue
level
at
the
2
ppm
dosing
level,
HED
will
make
use
of
the
poultry
fat
residue
level
determined
at
the
20
ppm
dosing
level.
Using
this
value,
HED
notes
that
no
change
results
in
the
chronic
anticipated
residue
level
for
poultry
fat
(
0.00012
ppm).

11.
Section
II
 
Table
12.
Acute
anticipated
residues
in
Swine.
HED
concurs
with
the
registrants
about
the
proper
residue
levels
for
muscle
and
fat.
These
levels
will
be
updated
in
Table
12
and
incorporated
in
a
revised
DEEM­
FCID
run.

12.
Section
II
 
Table
13.
Chronic
anticipated
residues
in
Swine.
HED
concurs
that
the
average
value
for
muscle
and
kidney
may
be
used
in
the
determination
of
the
chronic
anticipated
residue
values
for
swine.
To
alleviate
concerns
about
residue
levels
at
the
5
ppm
dosing
level,
HED
will
make
use
of
the
residue
levels
from
the
15
ppm
dosing
level.
Consequently,
these
values
will
be
updated
in
Table
13
and
incorporated
in
a
revised
DEEMFCID
run.

13.
Section
II
 
Table
14.
Data
and
Residue
Estimates
Used
in
Dietary
Analysis.
A.
HED
will
update
the
anticipated
residue
values
as
appropriate
in
Table
14.
B
&
C.
Although
the
registrant
has
correctly
identified
the
crop
subgroups
for
head
lettuce,
radicchio,
and
Chinese
cabbage
bok
choy,
Table
14
is
not
intended
to
be
arranged
strictly
by
crop
subgroup.
Instead,
Table
14
followed
the
grouping
recommendations
given
in
HED
SOP
99.3
dated
3/
26/
1999,
which
specifically
addresses
how
HED
should
translate
monitoring
data.
See
Attachment
1
for
a
copy
of
this
SOP.
Thus,
no
changes
to
the
data
translations
involving
head
lettuce,
radicchio
or
Chinese
cabbage
bok
choy
are
appropriate.

14.
Sections
V,
VI,
&
VII.
Update
the
exposure
numbers
to
reflect
the
requested
changes
to
the
anticipated
residue
levels.
.

4
Section
VI
contains
no
exposure
values.
HED
will
update
the
exposure
numbers
as
appropriate
in
Sections
V
&
VII
to
match
the
changes
already
noted
above.

15.
Use
of
DEEM
software
The
DEEM­
FCID
software
program
was
used
to
evaluate
the
dietary
exposures
because
this
was
the
software
used
by
EPA
for
dietary
analysis
at
the
time
of
the
analysis
(
15­
SEP­
2003).
HED
is
now
in
the
process
of
switching
to
the
Lifeline
software
package.
However,
experience
has
shown
that
similar
exposure
estimates
are
obtained
from
DEEM
and
Lifeline
when
using
the
same
input
data.
In
light
of
these
findings,
HED
has
determined
that
the
dietary
exposure
estimates
would
not
change
appreciably
by
using
Lifeline
and
that
a
compelling
reason
justifying
this
extra
work
has
not
been
provided.

16.
Over­
estimation
of
%
Crop
Treated,
as
shown
in
Table
14.
HED
concurs
that
the
100%
CT
estimate
for
tomato
is
an
overestimate.
It
was
used
because
no
estimate
from
BEAD
was
available
at
the
time
of
the
analysis.
BEAD
has
recently
provided
an
estimate
for
cypermethrin/
zeta­
cypermethrin
use
in/
on
tomatoes
of
1%
and
2%
for
average
and
maximum
percent
crop
treated,
respectively
(
email
message
of
2/
11/
04
from
A.
Halvorson
to
W.
Donovan).
These
revised
%
CT
estimates
for
tomato
will
be
used
in
updated
DEEM­
FCID
analyses.

After
incorporating
all
the
suggested
changes
as
discussed
above,
the
updated
DEEM­
FCID
results
are
listed
below
for
the
acute
and
chronic
analyses:

Table
1.
Results
of
Revised
Acute
Dietary
Exposure
Analysis
of
Cypermethrin/
zeta­
Cypermethrin
Population
Subgroup
aPAD
(
mg/
kg/
day)
95th
Percentile
99th
Percentile
99.9th
Percentile
Exposure
(
mg/
kg/
day)
%
aPAD
Exposure
(
mg/
kg/
day)
%
aPAD
Exposure
(
mg/
kg/
day)
%
aPAD
General
U.
S.
Population
0.01
0.000322
3.2
0.000856
8.6
0.002600
26
All
Infants
(<
1
year
old)
0.01
0.000431
4.3
0.000990
9.9
0.005644
56
Children
1­
2
years
old
0.01
0.001179
12
0.003141
31
0.006084
61
Children
3­
5
years
old
0.01
0.000896
9.0
0.001924
19
0.003687
37
Children
6­
12
years
old
0.01
0.000554
5.5
0.001249
12
0.002293
23
Youth
13­
19
years
old
0.01
0.000313
3.1
0.000705
7.1
0.001675
17
Adults
20­
49
years
old
0.01
0.000258
2.6
0.000536
5.4
0.001383
14
Females
13­
49
years
old
0.01
0.000243
2.4
0.000535
5.4
0.001415
14
Adults
50+
years
old
0.01
0.000226
2.3
0.000471
4.7
0.001397
14
.

5
Table
2.
Results
of
Revised
Chronic
Dietary
Exposure
Analysis
for
Cypermethrin/
zeta­
Cypermethrin
Population
Subgroup
cPAD
(
mg/
kg/
day)
Exposure
(
mg/
kg/
day)
%
cPAD
General
U.
S.
Population
0.006
0.000043
0.7
All
Infants
(<
1
year
old)
0.006
0.000049
0.8
Children
1­
2
years
old
0.006
0.000095
1.6
Children
3­
5
years
old
0.006
0.000083
1.4
Children
6­
12
years
old
0.006
0.000057
0.9
Youth
13­
19
years
old
0.006
0.000038
0.6
Adults
20­
49
years
old
0.006
0.000037
0.6
Females
13­
49
years
old
0.006
0.000035
0.6
Adults
50+
years
old
0.006
0.000034
0.6
The
above
changes
will
be
incorporated
into
the
risk
assessment
document.
These
changes
should
address
all
the
dietary
and
residue
chemistry
concerns
raised
during
the
error­
only
comment
period,
except
for
Comment
#
50
questioning
the
derivation
of
the
theoretical
dietary
burden
values
used
for
tolerance­
setting
purposes.
These
values
were
presented
in
the
cypermethrin
residue
chemistry
chapter
of
the
RED
[
D289422,
W.
Donovan,
25­
SEP­
2003],
Tables
1
&
3.
Because
these
values
were
used
for
tolerance­
setting
purposes,
they
were
computed
assuming
tolerance­
level
residues
for
the
listed
feed
commodities.

With
the
updated
dietary
exposure
values
now
in
hand
together
with
updated
estimated
environmental
concentrations
(
EECs)
for
cypermethrin
and
zeta­
cypermethrin
(
D298661,
J.
L.
Melendez,
17­
FEB­
2004),
HED
is
now
able
to
update
the
acute
and
chronic
DWLOC
calculations
from
the
risk
assessment
document.
These
updated
tables
are
provided
below.
Once
the
ORE
revisions
are
completed,
the
short­
and
intermediate­
term
aggregate
risk
and
DWLOC
tables
will
also
be
updated.
.

6
Table
5.1.1
Acute
DWLOC
Calculations.

Population
Subgroup
aPAD
mg/
kg/
day
Food
Exp
mg/
kg/
day
Max
Water
Exp
mg/
kg/
daya
Ground
Water
EEC
(:
g/
L)
Surface
Water
EEC
(:
g/
L)
DWLOC
(
µ
g/
L)
b
General
U.
S.
Population
0.01
0.002600
0.007400
0.006
4
260
All
Infants
(<
1
year
old)
0.005644
0.004356
44
Children
1­
2
years
old
0.006084
0.003916
39
Children
3­
5
years
old
0.003687
0.006313
63
Children
6­
12
years
old
0.002293
0.007707
77
Youth
13­
19
years
old
0.001675
0.008325
250
Adults
20­
49
years
old
0.001383
0.008617
300
Females
13­
49
years
old
0.001415
0.008585
260
Adults
50+
years
old
0.001397
0.008603
300
a
Maximum
water
exposure
(
mg/
kg/
day)
=
[(
acute
(
mg/
kg/
day)
­
food
exposure
(
mg/
kg/
day)]
b
DWLOC(
µ
g/
L)
=
[
maximum
water
exposure
(
mg/
kg/
day)
x
body
weight
(
kg)]
÷
[
water
consumption
(
L)
x
10­
3
mg/
µ
g].
Consumption
=
1
L/
day
for
populations
<
13
years
old
and
2
L/
day
for
populations
$
13
years
old.
Default
body
weights
=
70
kg
for
males
>
20
years
old
and
general
U.
S.
population,
60
kg
for
females
$
13
years
old
and
youths
13­
19
years
old,
and
10
kg
for
all
others.
Values
are
rounded
to
2
significant
figures.

Table
5.3.1
Chronic
DWLOC
Calculations.

Population
Subgroup
cPAD
mg/
kg/
day
Food
Exp
mg/
kg/
day
Max
Water
Exp
mg/
kg/
daya
Ground
Water
EEC
(:
g/
L)
Surface
Water
EEC
(:
g/
L)
DWLOC
(
µ
g/
L)
b
General
U.
S.
Population
0.006
0.000043
0.005957
0.006
0.43
210
All
Infants
(<
1
year
old)
0.000049
0.005951
60
Children
1­
2
years
old
0.000095
0.005905
59
Children
3­
5
years
old
0.000083
0.005917
59
Children
6­
12
years
old
0.000057
0.005943
59
Youth
13­
19
years
old
0.000038
0.005962
180
Adults
20­
49
years
old
0.000037
0.005963
210
Females
13­
49
years
old
0.000035
0.005965
180
Adults
50+
years
old
0.000034
0.005966
210
a
Maximum
water
exposure
(
mg/
kg/
day)
=
[(
chronic
PAD
(
mg/
kg/
day)
­
food
exposure
(
mg/
kg/
day)]
b
DWLOC(
µ
g/
L)
=
[
maximum
water
exposure
(
mg/
kg/
day)
x
body
weight
(
kg)]
÷
[
water
consumption
(
L)
x
10­
3
mg/
µ
g].
Consumption
=
1
L/
day
for
populations
<
13
years
old
and
2
L/
day
for
populations
$
13
years
old.
Default
body
weights
=
70
kg
for
males
>
20
years
old
and
general
U.
S.
population,
60
kg
for
females
$
13
years
old
and
youths
13­
19
years
old,
and
10
kg
for
all
others.
Values
are
rounded
to
2
significant
figures.
.

7
HED
responses
to
Draft
RED
for
cypermethrin
and
Zeta­
Cypermethrin:
Comments
(
Error
only)
Concerning
Mammalian
Toxicology
and
Hazard
End­
point
Selection
1.
Discrepancy
between
the
HIARC
report
and
HED
risk
assessment
document
concerning
the
required
margin
of
exposure
for
long­
term
residential
inhalation
exposure.

The
correct
value
for
this
quantity
is
3000
as
listed
in
the
risk
assessment
document.
The
HIARC
report
will
be
updated
to
harmonize
with
the
risk
assessment
on
this
matter.

2.
Section
II.
2
of
HIARC
document
contains
a
grammatical/
typographical
error
in
the
5th
sentence
of
page
16.

HED
concurs
that
this
sentence
is
not
clear.
Consequently,
the
entire
paragraph
will
be
replaced
with
the
following
text:

"
In
1997,
the
HIARC
selected
the
chronic
dietary
endpoint
for
zeta­
cypermethrin
from
a
chronic
oral
study
in
the
dog
conducted
with
cypermethrin.
In
that
study,
the
test
article
was
administered
in
corn
oil
via
capsules.
The
NOAEL
was
1
mg/
kg/
day
based
on
an
increased
incidence
of
loose
stools,
starting
on
the
first
week
of
the
study
at
5
mg/
kg/
day.
Since
1997,
a
chronic
feeding
study
in
the
dog
was
conducted
with
cypermethrin.
The
current
HIARC
determined
that
the
new
chronic
feeding
study
is
more
appropriate
for
the
chronic
dietary
endpoint
because
dietary
exposure
is
more
relevant
for
the
anticipated
exposure
to
humans
and
the
gastrointestinal
effects
in
the
capsule
dog
study
may
be
due
to
focal
exposure
(
bolus
dose
with
corn
oil).
Although
no
chronic
oral
studies
have
been
conducted
with
zeta­
cypermethrin,
the
chronic
dietary
endpoint
selected
from
a
study
conducted
with
cypermethrin
is
expected
to
be
protective
of
chronic
dietary
exposure
to
zeta­
cypermethrin.
This
conclusion
is
based
on
a
comparison
of
the
results
from
the
multi­
generation
reproduction
studies
conducted
with
both
zeta­
cypermethrin
and
cypermethrin.
The
parental
NOAEL
and
LOAEL
for
the
2­
generation
reproduction
study
conducted
with
zeta­
cypermethrin
are
7
and
27
mg/
kg/
day,
respectively.
These
values
are
comparable
to
the
parental
NOAEL
(
7.5
mg/
kg/
day)
and
LOAEL
(
50/
37.5
mg/
kg/
day)
observed
with
the
acceptable
rat
reproduction
study
conducted
with
cypermethrin.
The
NOAEL/
LOAEL
(
7.5/
75
mg/
kg/
day)
in
the
chronic
rat
study
conducted
with
cypermethrin
provide
additional
support
to
the
critical
study
selected
for
the
chronic
dietary
endpoint.
In
addition,
the
A
target
organ
@

(
clinical
signs
of
neurotoxicity)
is
of
particular
relevance
to
pyrethroid
toxicity."

3.
Comments
pertaining
to
the
developmental
neurotoxicity
(
DNT)
data
requirement
for
cypermethrin.

HED
will
change
the
first
paragraph
of
the
DNT
section
in
the
HIARC
report
(
page
12)
to
read
as
follows:
.

8
"
The
HIARC
concluded
that
there
is
a
concern
for
developmental
neurotoxicity
resulting
from
exposure
to
zeta­
cypermethrin
and
cypermethrin.
On
November
16
and
December
19,
2000,
HIARC
recommended
that
a
developmental
neurotoxicity
study
in
rats
be
conducted.
Zeta­
cypermethrin
was
chosen
as
the
preferred
test
compound
since
it
produced
neurotoxic
effects
at
lower
doses
in
both
the
acute
and
subchronic
mammalian
neurotoxicity
studies
than
cypermethrin.
Using
this
test
compound
will
most
likely
result
in
a
NOAEL/
LOAEL
that
is
protective
of
any
effects
noted
in
a
study
with
cypermethrin,
thus
negating
the
need
for
two
studies,
one
on
each
chemical.
The
recommendation
to
conduct
a
developmental
neurotoxicity
study
with
zetacypermethrin
is
based
on
the
following
considerations:"

In
addition
to
the
above
text,
the
following
text
will
replace
the
existing
data
gap/
requirements
section
of
the
HIARC
report
(
page
27):

"
Cypermethrin
Developmental
neurotoxicity
study
(
83­
6,
870.6300).
This
requirement
may
be
fulfilled
by
a
developmental
neurotoxicity
study
conducted
using
zetacypermethrin

cc:
W.
Donovan,
C.
Eiden,
P.
Hurley
RDI:
C.
Eiden
(
3/
5/
04)
.
ATTACHMENT
1.
SOP
99.3
UNITED
STATES
ENVIRONMENTAL
PROTECTION
AGENCY
WASHINGTON,
D.
C.
20460
OFFICE
OF
PREVENTION,
PESTICIDES
AND
TOXIC
SUBSTANCES
MEMORANDUM
DATE:
March
26,
1999
SUBJECT:
Translation
of
Monitoring
Data.
HED
Standard
Operating
Procedure
99.3
(
3/
26/
99)

FROM:
Margaret
Stasikowski,
Director
Health
Effects
Division
TO:
Health
Effects
Division
Staff
Attached
is
SOP
99.3
 
"
Translation
of
Monitoring
Data."
This
is
the
latest
HED
Standard
Operating
Procedure;
it
was
issued
on
March
26,
1999.

This
policy
provides
guidance
on
translating
pesticide
monitoring
data
from
one
commodity
to
other
similar
commodities.
The
policy
is
based
on
the
crop
groupings
in
the
40
CFR
180.41,
and
180.34.

If
you
have
any
questions,
please
contact
Sue
Hummel
(
305­
7689)
or
William
Hazel
(
305­
7677).

Attachment:
HED
SOP
99.3
(
2
pp.)
.
HED
SOP
99.3
Translation
of
Monitoring
Data
(
March
26,
1999)
1
The
Health
Effects
Division
has
had
a
long­
standing
policy
in
which
composite
USDA
Pesticide
Data
Program
(
PDP)
or
FDA
data
can
be
used
in
chronic
risk
assessments.
This
policy
also
extended
to
use
of
composite
USDA
PDP
(
or
FDA)
data
for
blended
commodities
such
as
grains,
most
juices,
oils,
etc.
in
acute
risk
assessments.
The
Division
has
now
recently
proposed
a
policy
for
the
use
of
certain
composite
USDA
PDP
monitoring
data
for
non­
blended
commodities
in
acute
Monte­
Carlo
assessments
when
a
statistical
"
decompositing"
is
performed.
This
latter
policy
would
allow
more
widespread
use
of
USDA
PDP
data
in
our
acute
exposure
and
risk
assessments.

In
addition,
the
Division
also
now
permits
USDA
PDP
residue
data
on
certain
crops
to
be
translated
to
other
similar
crops
when
certain
conditions
are
met.
This
translation
can
be
performed
whenever
it
is
appropriate
to
use
PDP
monitoring
data
in
a
chronic
or
acute
risk
assessment
(
as
indicated
above).
This
SOP
details
these
translation
criteria
and
should
be
consulted
whenever
PDP
data
are
available
and
appropriate
for
use
in
chronic
and
acute
risk
assessments.
The
translation
criteria
are
primarily
based
on
the
crop
grouping
schemes
detailed
in
40
CFR
180.41,
which
should
be
consulted
for
a
complete
listing
of
crops
that
can
be
translated.*

Table
1
on
the
following
page
presents
the
crops
for
which
the
Division
permits
translation.
This
table
is
largely
based
on
crop
groups
and
crop
subgroups.
Generally
(
but
see
below),
residue
data
from
crops
in
the
first
column
can
be
translated
to
those
crops
listed
in
the
second
column.
Only
in
case­
by­
case
situations
should
reverse
translations
from
crops
in
the
second
column
to
those
in
the
first
be
performed.
In
many
cases
crops
in
the
second
column
are
consumed
with
less
frequency
and/
or
in
lower
quantities
than
those
in
the
first
column
and
translations
in
this
direction
(
e.
g.,
from
rhubarb
to
spinach)
would
potentially
subject
exposure
estimates
to
substantially
greater
uncertainty.
This
SOP
focuses
on
crops
PDP
has
analyzed.
In
the
event
additional
crops
are
analyzed,
HED,
via
ChemSAC,
will
address
the
extent
of
translation
possible.
Usually,
the
crop
group/
sub­
group
scheme
at
40
CFR
180.41
will
serve
as
a
guide.

In
the
translation
process,
the
reviewer
also
should
be
aware
of
the
food
form
being
analyzed.
The
PDP
also
has
collected
samples
of
processed
(
cooked
and
frozen)
vegetables
in
addition
to
raw
agricultural
commodities.

In
addition,
the
reviewer
should
take
special
note
of
the
requirement
that
the
use
scenarios
be
similar
among
translatable
commodities.
The
mode
of
application
(
e.
g.,
foliar,
preplant)
should
be
the
same.
The
label
application
rates
and
preharvest
intervals
should
be
similar.
The
percent
of
crop
treated
also
should
be
similar
(
or
lower
for
the
crop
in
the
"
translated
to"
column).
All
residues
of
concern
should
be
measured
or
accounted
for
including
conjugates.
Tolerances
and
field
trial
residues
are
to
be
similar,
as
well.
The
reviewer
should
check
with
the
Biological
and
Economic
Analysis
Division
(
BEAD)
to
ensure
that
use
scenarios
are
similar
and
that
agricultural
practices
do
not
differ
substantially.

For
example,
if
the
use
rate
on
potatoes
is
2
lbs
ai/
A
with
a
label­
specified
preharvest
.
HED
SOP
99.3
Translation
of
Monitoring
Data
(
March
26,
1999)
2
interval
of
14
days
while
the
use
rate
for
sweet
potato
is
4
lbs
ai/
A
with
a
7
day
PHI,
it
would
be
inappropriate
to
use
PDP
data
for
potatoes
as
a
surrogate
for
sweet
potato.

*
For
detailed
descriptions
of
each
crop
within
the
crop
groups,
see
G.
Markle,
J.
Baron,
and
B.
A.
Schneider,
Food
and
Feed
Crops
of
the
United
States,
Second
Edition,
Meister
Publishing,
Willoughby,
OH,
1998.
.
HED
SOP
99.3
Translation
of
Monitoring
Data
(
March
26,
1999)
3
Table
1.
Permissible
Crop
Translations
for
Pesticide
Monitoring
Data1
Commo
dity
Analyze
d
...
Commodity
translated
to...
Comments
Potato
Subgroup
1­
C
Carrot
Subgroup
1­
A
or
1­
C
Head
Lettuce
Cabbage,
Chinese
cabbage
napa
(
tight
headed
varieties),
Brussels
sprouts,
radicchio
All
have
a
head
morphology
best
represented
by
lettuce.
All
are
in
Subgroup
5­
A
except
radicchio
(
4­
A).

Broccoli
Cauliflower,
Chinese
broccoli,
Chinese
cabbage
bok
choy,
Chinese
mustard,
kohlrabi
Broccoli
better
represents
these
heading,
thickly
stemmed
and/
or
more
branching
cole
crops
than
spinach
does.

Spinach
Subgroup
4­
A,
Subgroup
5­
B
and
Subgroup
4­
B
(
except
celery
and
fennel
unless
a
strong
case
can
be
made)
Celery
and
fennel
typically
are
excluded
since
residues
may
be
higher
in
these
crops
due
to
the
whorled,
overlapping
petioles
which
may
retain
spray
residues.

Green
Bean
Subgroups
6­
A
and
6­
B
Soybean
Subgroup
6­
C
Tomato
or
bell
pepper
Group
8
All
are
fruiting
vegetables2.

Cucumb
er
Subgroup
9­
B
All
are
cucurbit
vegetables;
residues
in
melon
and
pumpkin
expected
to
be
lower
because
of
removal
of
rind
Cantalou
pe
or
Winter
squash
Subgroup
9­
A
and
pumpkin
Orange
Group
10
Fruit
will
be
peeled
before
analysis
by
PDP.

Apple
or
Pear
Group
11
All
are
pome
fruits.
.
HED
SOP
99.3
Translation
of
Monitoring
Data
(
March
26,
1999)
4
Peach
Group
12,
except
cherries
(
sweet
and
tart)
All
are
stone
fruits.

Grape
Kiwifruit
Based
on
similar
cultural
practices.

Wheat
Group
15,
except
corn,
rice,
or
wild
rice
All
are
small
grain
crops
or
closely
related
thereto
Milk
Meat
Metabolism
study
must
indicate
that
residues
in
meat,
fat,
and
meat­
byproducts
will
likely
be
equal
to
or
lower
than
residues
in
milk.
If
dermal
use
is
allowed
on
beef
cattle,
then
it
must
be
permitted
and
used
on
dairy
cattle
as
well.

1
The
reviewer
should
take
special
note
of
the
requirement
that
the
use
scenarios
be
similar
among
translatable
commodities.
The
mode
of
application
(
e.
g.,
foliar,
preplant)
should
be
the
same.
The
label
application
rates
and
preharvest
intervals
should
be
similar.
The
percent
of
crop
treated
also
should
be
similar
(
or
lower
for
the
crop
in
the
"
translated
to"
column).
All
residues
of
concern
should
be
measured
or
accounted
for
including
conjugates.
Tolerances
and
field
trial
residues
are
to
be
similar,
as
well.
The
reviewer
should
also
check
with
the
Biological
and
Economic
Analysis
Division
(
BEAD)
to
insure
that
use
scenarios
are
similar,
and
that
agricultural
practices
do
not
differ
substantially.
2
The
reviewer
should
be
careful
in
checking
for
comparable
residue
levels
because
of
weight
differences
in
tomatoes
and
peppers.