Page
1
of
50
UNITED
STATES
ENVIRONMENTAL
PROTECTION
AGENCY
WASHINGTON,
D.
C.
20460
OFFICE
OF
PREVENTION,
PESTICIDES
AND
TOXIC
SUBSTANCES
February
1,
2006
SUBJECT:
Imazalil.
Reregistration
List
B
Chemical
Number
111901;
Case
No.
2325
Revised
Product
and
Residue
Chemistry
Chapters
for
the
HED
Risk
Assessment.
No
MRID
No.
DP
Barcode
D294373.

FROM:
Thurston
Morton,
Chemist
Reregistration
Branch
4
Health
Effects
Division
(
7509C)

and
David
E.
Hrdy,
Biologist
Reregistration
Branch
4
Health
Effects
Division
(
7509C)

THRU:
Susan
V.
Hummel,
Branch
Senior
Scientist
Reregistration
Branch
4
Health
Effects
Division
(
7509C)

TO:
Kendra
Tyler
Special
Review
Branch
Special
Review
&
Reregistration
Division
(
7508C)

Attached
is
the
revised
Residue
Chemistry
Chapter
for
the
reregistration
eligibility
document
(
RED).
This
revision
corrects
the
previous
Residue
Chemistry
Chapter
by
reassessing
the
horse,
fat
tolerance
at
0.01
ppm
and
correcting
the
commodity
definitions.
This
was
originally
completed
by
Dynamac
Corporation
under
supervision
of
HED.
It
has
undergone
secondary
review
in
the
branch
and
has
been
revised
to
reflect
current
Agency
policies.
Page
2
of
50
Outstanding
data
required
at
the
present
time
include:
GLN
830.7050,
UV/
Visible
Absorption,
GLN
860.1340,
analytical
method
for
imazalil
in
livestock
tissue
and
,
GLN
860.1360,
multiresidue
method
data
for
imazalil
metabolites,
GLN
860.1480,
residue
data
resulting
from
a
fumigation
application
to
poultry
houses.

cc
:
Chem
F,
Chron
F,
Morton,
Hrdy
RDI:
SVH:
2/
1/
06
TM,
Thurston
Morton,
Rm.
816D
CM2,
305­
6691,
mail
code
7509C
Page
3
of
50
Cl
Cl
O
N
N
CH
2
IMAZALIL
REREGISTRATION
ELIGIBILITY
DECISION:

PRODUCT
CHEMISTRY
CONSIDERATIONS
PC
Code
111901;
Case
No.
2325
DESCRIPTION
OF
CHEMICAL
Imazalil
[
1­(
2­(
2,4­
dichlorophenyl)­
2­(
2­
propenyloxy)
ethyl)­
1H­
imidazole]
is
a
systemic
fungicide
used
for
postharvest
treatment
of
citrus
fruits
and
bananas
(
foreign
use)
and
for
seed
treatment
of
barley
and
wheat
prior
to
planting.

Empirical
Formula:
C
14
H
14
Cl
2
N
2
O
Molecular
Weight:
297.17
CAS
Registry
No.:
73790­
28­
0
PC
Code:
111901
IDENTIFICATION
OF
ACTIVE
INGREDIENT
Imazalil
is
a
yellow
or
brown
crystalline
solid
with
a
melting
point
of
50
C,
density
of
1.348
x
103
kg/
m3,
octanol/
water
partition
coefficient
(
log
P
ow
)
of
3.82,
and
vapor
pressure
of
3.6
x
10­
4
Pa
at
25
C.
Imazalil
is
slightly
soluble
in
water
(
293
ppm
at
20
C),
and
is
very
soluble
in
methanol,
ethanol,
2­
propanol,
dimethylbenzene,
acetonitrile,
N,
N­
dimethylformamide,
tetrahydrofuran,
1­
methyl­
2­
pyrrolidinone,
1,2­
ethanediol,
1,2­
propanediol,
and
glacial
acetic
acid
(>
500
g/
L
at
25
C).

MANUFACTURING­
USE
PRODUCTS
A
search
of
the
Reference
Files
System
(
REFS)
conducted
1/
22/
02
identified
two
imazalil
manufacturing­
use
products
(
MP)
registered
under
PC
Code
111901:
the
Janssen
Pharmaceutic
97.5%
technical
(
T;
EPA
Reg.
No.
43813­
2)
and
the
Makhteshim­
Agan
of
North
America
Inc.
(
MANA)
98.5%
technical
(
T;
EPA
Reg.
No.
11678­
55).
Both
technicals
are
subject
to
a
reregistration
eligibility
decision.
Page
4
of
50
REGULATORY
BACKGROUND
The
Imazalil
Phase
4
Review
dated
10/
19/
90
by
S.
Funk
determined
that
additional
data
were
required
concerning
all
product
chemistry
guidelines
except
OPPTS
830.1550
(
product
identity)
for
imazalil;
the
product
chemistry
data
submission
for
OPPTS
830.1550
was
determined
to
be
acceptable
for
Phase
5
review.
Subsequent
to
the
Phase
4
Review,
all
new
product
chemistry
data
have
been
submitted
in
support
of
the
reregistration
of
imazalil.

The
current
status
of
the
product
chemistry
data
requirements
for
the
imazalil
T/
TGAI
is
presented
in
the
attached
data
summary
table.
Refer
to
this
table
for
a
listing
of
the
outstanding
product
chemistry
data
requirements.

CONCLUSIONS
All
pertinent
product
chemistry
data
requirements
have
been
satisfied
for
the
Janssen
97.5%
T/
TGAI,
except
that
additional
data
are
required
concerning
UV/
visible
absorption
(
OPPTS
830.7050).
Provided
that
the
registrant
submits
the
data
required
in
the
attached
data
summary
table
for
the
imazalil
T/
TGAI,
and
either
certifies
that
the
suppliers
of
beginning
materials
and
the
manufacturing
process
have
not
changed
since
the
last
comprehensive
product
chemistry
review
or
submits
a
complete
updated
product
chemistry
data
package,
HED
has
no
objections
to
the
reregistration
of
imazalil
with
respect
to
product
chemistry
data
requirements.

All
pertinent
product
chemistry
data
requirements
have
been
satisfied
for
the
Makhteshim­
Agan
of
North
America
Inc.
(
MANA)
98.5%
technical
T/
TGAI,
except
that
additional
data
are
required
concerning
UV/
visible
absorption
(
OPPTS
830.7050).
Provided
that
the
registrant
submits
the
data
required
in
the
attached
data
summary
table
for
the
imazalil
T/
TGAI,
and
either
certifies
that
the
suppliers
of
beginning
materials
and
the
manufacturing
process
have
not
changed
since
the
last
comprehensive
product
chemistry
review
or
submits
a
complete
updated
product
chemistry
data
package,
HED
has
no
objections
to
the
reregistration
of
imazalil
with
respect
to
product
chemistry
data
requirements.
Page
5
of
50
AGENCY
MEMORANDA
CITED
IN
THIS
DOCUMENT
CBRS
No(
s):
6098
Subject:
Dioxin
Review
for
Imazalil
From:
S.
Funk
To:
Dated:
2/
23/
90
MRID(
s):
40478201
CBRS
No(
s):
7014
Subject:
Product
Chemistry
Data
Review
for
Technical
Imazalil
to
Determine
the
Potential
for
Halogenated
Dibenzo­
p­
Dioxin/
Dibenzofuran
Formation.
Additional
Data.
I.
D.
No.
43813­
1.
Rereg
Case
No.
2325.
From:
S.
Funk
To:
K.
Davis
Dated:
11/
16/
90
MRID(
s):
41595901
CBRS
No(
s):
7117
DP
Barcode(
s):
D156801
Subject:
Supplement
to
Phase
3
Registrant
Response
and
Reply
to
Manufacturing
DCI
to
Evaluate
the
Potential
for
Halogenated
Dibenzo­
p­
dioxin/
Dibenzofuran
Formation.
Reregistration
Case
No.
2325
From:
S.
Funk
To:
K.
Davis
Dated:
5/
10/
91
MRID(
s):
41545101
CBRS
No(
s):
10342
DP
Barcode(
s):
D181284
Subject:
Imazalil.
Product
Chemistry
Data
and
Stability
of
3H­
Imazalil.
From:
L.
Cheng
To:
K.
Davis
Dated:
9/
25/
92
MRID(
s):
40478201
CBRS
No(
s):
8845
DP
Barcode(
s):
D170516
Subject:
Reregistration
of
Imazalil.
Janssen
Pharmaceutica
97.5%
T
(
EPA
Reg.
No.
43813­
2).
From:
P.
Deschamp
To:
J.
Ellenberger/
B.
Briscoe
Dated:
10/
8/
92
MRID(
s):
41606106
and
41889801
Page
6
of
50
CBRS
No(
s):
11365
DP
Barcode(
s):
D187938
Subject:
Reregistration
of
Imazalil.
Janssen
Pharmaceutica
Product
Chemistry
Data
for
their
97.5%
T
(
EPA
Reg.
No.
43813­
2).
List
B
Case
No.
2325.
Chemical
No.
111901.
From:
P.
Deschamp
To:
K.
Depukat
Dated:
3/
18/
93
MRID(
s):
None
CBRS
No(
s):
12010
DP
Barcode(
s):
D192069
Subject:
Reregistration
of
Imazalil.
Janssen
Pharmaceutical
Product
Chemistry
Data
for
the
97.5%
Technical
(
EPA
Reg.
No.
43813­
2).
List
B
Case
No.
2325.
From:
S.
Funk
To:
K.
Davis/
K.
Depukat
Dated:
8/
12/
93
MRID(
s):
42793800­
42793802,
and
42403101
CBRS
No(
s):
12920
DP
Barcode(
s):
D197279
Subject:
Imazalil.
Case
No.
2325.
Janssen
Pharmaceutical
Product
Chemistry
Data
§
61­
1
for
the
97.5%
Technical
(
EPA
Reg.
No.
43813­
2).
From:
L.
Cheng
To:
K.
Depukat
Dated:
3/
8/
94
MRID(
s):
43016801
CBRS
No(
s):
13708
DP
Barcode(
s):
D203270
Subject:
Imazalil
Reregistration.
Janssen's
5/
5/
94
Response
[
61­
2(
b)
Data
for
Product
43813­
2]
to
Agency
4/
6/
94
Letter.
From:
K.
Dockter
To:
K.
Davis/
K.
Depukat
Dated:
7/
18/
95
MRID(
s):
43223001
DP
Barcode(
s):
D231609
Subject:
Product
Chemistry
Review
of
Imazalil
Technical.
From:
A.
Smith
To:
J.
Stone
Dated:
4/
10/
97
MRID(
s):
44107201­
11,
44107218,
44134401,
44134402,
44145401
Page
7
of
50
PRODUCT
CHEMISTRY
CITATIONS
Bibliographic
citations
include
only
MRIDs
containing
data
which
fulfill
data
requirements.

References
(
cited):

40478201
Goodwine,
W.
(
1987)
Product
Identity
and
Composition
[
Imazalil]:
IMZ­
PC­
61.
Unpublished
study
prepared
by
Janssen
Pharmaceutica.
334
p.

41545101
Goodwine,
W.
(
1987)
Product
Identity
and
Composition:
Imazalil:
Lab
Project
Number:
IMZ­
PC­
61.
Unpublished
study
prepared
by
Janssen
Pharmaceutica.
8
p.

41595901
Janssen
Pharmaceutica
(
1990)
1,
3­
Dichlorobenzene
Manufacturing
Process
and
Impurities:
Supplement:
Lab
Project
Number:
IMZ­
PC­
61.
Unpublished
study.
8
p.

41606106
Crauwils,
R.;
Dingenen,
J.
(
1990)
Physical
and
Chemical
Characteristics
of
Imazalil
(
R23979):
Fungaflor
Technical:
Lab
Project
Number:
IMZ­
PC­
63
(
1).
Unpublished
study
prepared
by
Janssen
Pharmaceutica.
101
p.

41889801
Niusmans,
S.;
Lauwers,
W.;
Smet,
M.
(
1991)
Analysis
and
Certification
of
Product
Ingredients
Fungaflor
Technical:
Lab
Project
Number:
IMZ
PC­
62.
Unpublished
study
prepared
by
Janssen
Research
Foundation.
75
p.

42403101
Goodwine,
W.
(
1987)
Supplement
to
MRID
40478201:
Product
Identity
and
Composition,
Guideline
Series
61:
Description
of
Beginning
Materials
and
Manufacturing
Process.
Unpublished
study
prepared
by
Janssen
Pharmaceutica.
7
p.

42793801
Nijsmans,
G.;
Lauwers,
W.;
DeSmet,
M.
(
1993)
Analysis
and
Certification
of
Product
Ingredients
Fungaflor
Technical:
Lab
Project
Number:
IMZ
PC­
62:
ST­
BO
GC­
930323:
ST­
QA
93­
8.
Unpublished
study
prepared
by
Janssen
Pharmaceutica.
72
p.

42793802
Crauwels,
R.;
Van
Dingenen,
J.
(
1993)
Physical
and
Chemical
Characteristics
of
Imazalil
Fungaflor
Technical:
Lab
Project
Number:
IMZ
PC­
63:
930409:
PC­
CHAR
93­
17.
Unpublished
study
prepared
by
Janssen
Pharmaceutica.
21
p.
43016801
Janssen
(
1993)
Supplement
to
Primary
MRID
40478201
and
Secondary
MRID
41889801:
Product
Identity
and
Composition­
Imazalil:
Lab
Project
Number:
IMZ­
PC­
61.
Unpublished
study.
13
p.

43016801
Janssen
(
1993)
Supplement
to
Primary
MRID
40478201
and
Secondary
MRID
41889801:
Product
Identity
and
Composition­
Imazalil:
Lab
Project
Number:
IMZ­
PC­
61.
Unpublished
study.
13
p.

43223001
Goodwine,
W.
(
1994)
Product
Identity
&
Composition:
Discussion
of
Impurities:
Imazalil:
Supplement:
Lab
Project
Number:
IMZ­
PC­
61.
Unpublished
study
prepared
by
Janssen
Pharmaceutica.
7
p.

44107201
Morrisey,
M.
(
1995)
Determination
of
Identity,
Purity,
and
Stability
for
Standards
Used
for
Impurity
Analysis
of
Magnate
(
Technical):
Study
Number:
HWI6413­
115.
Unpublished
study
Submitted
by
Makhteshim
Chemical
Works,
Ltd.

44107202Registration
Department,
Makhteshim
Chemical
Works,
LTD.
(
1996)
Magnate
(
Imazalil
Technical)
Product
Chemistry
Data:
Study
Number:
R9236.
Unpublished
study
Submitted
by
Makhteshim
Chemical
Works,
Ltd.
Page
8
of
50
44107203
Morrisey,
M.
(
1995)
Analysis
of
Magnate
(
Imazalil)
Technical
and
its
Impurities:
Study
Number:
HWI6413­
116.
Unpublished
study
Submitted
by
Makhteshim
Chemical
Works,
Ltd.

44107204
Morrisey,
M.
(
1996)
Color
Determination
of
Imazalil
TGAI:
Study
Number:
HWI6413­
118.
Unpublished
study
Submitted
by
Makhteshim
Chemical
Works,
Ltd.

44107205
Morrisey,
M.
(
1996)
Physical
State
Determination
of
Imazalil
TGAI:
Study
Number:
HWI6413­
119.
Unpublished
study
Submitted
by
Makhteshim
Chemical
Works,
Ltd.

44107206
Morrisey,
M.
(
1996)
Odor
Determination
of
Imazalil
TGAI:
Study
Number:
HWI6413­
120.
Unpublished
study
Submitted
by
Makhteshim
Chemical
Works,
Ltd.

44107207
Morrisey,
M.
(
1995)
Series
63
Product
Chemistry
Determinations
of
Magnate
(
Imazalil)
Technical
(
Melting
Point):
Study
Number:
HWI6413­
117A.
Unpublished
study
Submitted
by
Makhteshim
Chemical
Works,
Ltd.

44107208
Morrisey,
M.
(
1995)
Series
63
Product
Chemistry
Determinations
of
Magnate
(
Imazalil)
Technical
(
Relative
Density):
Study
Number:
HWI6413­
117B.
Unpublished
study
Submitted
by
Makhteshim
Chemical
Works,
Ltd.

44107209
Morrisey,
M.
(
1995)
Series
63
Product
Chemistry
Determinations
of
Magnate
(
Imazalil)
Technical
(
Solubility
in
Organic
Solvents):
Study
Number:
HWI6413­
117C.
Unpublished
study
Submitted
by
Makhteshim
Chemical
Works,
Ltd.

44107210
Teeter,
D.
(
1996)
Dissociation
Constant
Determinations
of
Imazalil
TGAI:
Study
Number:
HWI6413­
123.
Unpublished
study
Submitted
by
Makhteshim
Chemical
Works,
Ltd.

44107211
Morrisey,
M.
(
1996)
Octanol/
Water
Partition
Coefficient
Determination
of
Imazalil
TGAI:
Study
Number:
HWI6413­
121.
Unpublished
study
Submitted
by
Makhteshim
Chemical
Works,
Ltd.

44107218
Hogg,
A.
(
1991)
Imazalil
(
Batch
No:
1471­
24/
2)
Determination
of
Vapor
Pressure:
Study
Number:
306/
59.
Unpublished
study
Submitted
by
Makhteshim
Chemical
Works,
Ltd.

44134401
August,
J.
(
1996)
pH
Determination
of
Magnate
(
Imazalil)
Technical:
Study
Number:
CHW
6413­
142.
Unpublished
study
Submitted
by
Makhteshim
Agan
of
North
America,
Inc.

44134402
August,
J.
(
1996)
Stability
Determination
of
Magnate
(
Imazalil)
Technical:
Study
Number:
CHW
6413­
142.
Unpublished
study
Submitted
by
Makhteshim
Agan
of
North
America,
Inc.
Page
9
of
50
Case
No.
2325
Chemical
No.
111901
Case
Name:
Imazalil
Registrant:
Janssen
Pharmaceutics
Product(
s):
97.5%
T
(
EPA
Reg.
No.
43813­
2)

PRODUCT
CHEMISTRY
DATA
SUMMARY
Guideline
Number
Requirement
Are
Data
Requirements
Fulfilled?
1
MRID
Number
2
830.1550
Product
identity
and
composition
Y
40478201,
42793800
3,
42793802
3,
43016801
4
830.1600
Description
of
materials
used
to
produce
the
product
Y
40478201,
41595901
5,
41545101
6,
42403101
3
830.1620
Description
of
production
process
Y
40478201,
41595901
5,
41545101
6,
42403101
3
830.1670
Discussion
of
formation
of
impurities
Y
40478201,
43223001
7
830.1700
Preliminary
analysis
Y
41889801
830.1750
Certified
limits
Y
41889801,
Letter
2/
9/
93
8,
42793800
3
830.1800
Enforcement
analytical
method
Y
41889801,
Letter
2/
9/
93
8,
42793801
3
830.6302
Color
Y
41606106
830.6303
Physical
state
Y
41606106
830.6304
Odor
Y
41606106
830.6313
Stability
to
normal
and
elevated
temperatures,
metals,
and
metal
ions
Y
41606106,
Letter
2/
9/
93
8,
42793802
3
830.7000
pH
Y
41606106
830.7050
UV/
Visible
absorption
N
9
830.7200
Melting
point/
melting
range
Y
41606106
830.7220
Boiling
point/
boiling
range
N/
A
10
830.7300
Density/
relative
density/
bulk
density
Y
41606106
830.7370
Dissociation
constants
in
water
Y
41606106
830.7550
Partition
coefficient
(
n­
octanol/
water),
shake
flask
method
Y
41606106
830.7840
Water
solubility:
column
elution
method;
shake
flask
method
Y
41606106,
Letter
2/
9/
93
8,
42793802
3
830.7950
Vapor
pressure
Y
41606106
1
Y
=
Yes;
N
=
No;
N/
A
=
Not
Applicable.

2
The
bolded
reference
was
evaluated
in
the
Imazalil
Phase
4
Review,
10/
19/
90,
S.
Funk
and
was
subsequently
reviewed
under
CBRS
No.
6098,
2/
23/
90,
S.
Funk,
and
CBRS
No.
10342,
D181384,
9/
25/
92
L.
Cheng
(
for
OPPTS
830.1600
and
1620
only);
underlined
references
were
reviewed
under
CBRS
No.
8845,
D170516,
10/
8/
92,
P.
Deschamp;
and
all
other
references
were
reviewed
as
noted.
Page
10
of
50
3
CBRS
No.
12010,
D192069,
8/
12/
93,
S.
Funk.

4
CBRS
No.
12920,
D197279,
3/
8/
94,
L.
Cheng.

5
CBRS
No.
7014,
11/
16/
90,
S.
Funk.

6
CBRS
No.
7117,
D156801,
5/
10/
91,
S.
Funk.

7
CBRS
No.
13708,
D203270,
7/
18/
95,
K.
Dockter.

8
CBRS
No.
11365,
D187938,
3/
18/
93,
P.
Deschamp.

9
The
OPPTS
Series
830,
Product
Properties
Test
Guidelines
require
data
pertaining
to
UV/
visible
absorption
for
the
PAI.

10
Data
are
not
required
because
the
TGAI
is
a
solid
at
room
temperature.
Page
11
of
50
Case
No.
2325
Chemical
No.
111901
Case
Name:
Imazalil
Registrant:
Makhteshim­
Agan
of
North
America
Inc.
(
MANA)
Product(
s):
98.5%
T
(
EPA
Reg.
No.
11678­
55)

PRODUCT
CHEMISTRY
DATA
SUMMARY
Guideline
Number
Requirement
Are
Data
Requirements
Fulfilled?
1
MRID
Number
830.1550
Product
identity
and
composition
Y
4410702
2
830.1600
Description
of
materials
used
to
produce
the
product
Y
4410702
2
830.1620
Description
of
production
process
Y
4410702
2
830.1670
Discussion
of
formation
of
impurities
Y
4410702
2
830.1700
Preliminary
analysis
Y
4410703
2
830.1750
Certified
limits
Y
4410703
2
830.1800
Enforcement
analytical
method
Y
4410703
2
830.6302
Color
Y
4410704
2
830.6303
Physical
state
Y
44107205
2
830.6304
Odor
Y
44107206
2
830.6313
Stability
to
normal
and
elevated
temperatures,
metals,
and
metal
ions
Y
44134402
2
830.7000
pH
Y
44134401
2
830.7050
UV/
Visible
absorption
N3
830.7200
Melting
point/
melting
range
Y
44107207
2
830.7220
Boiling
point/
boiling
range
N/
A
4
830.7300
Density/
relative
density/
bulk
density
Y
44107208
2
830.7370
Dissociation
constants
in
water
Y
44107210
2
830.7550
Partition
coefficient
(
n­
octanol/
water),
shake
flask
method
Y
44107211
2
830.7840
Water
solubility:
column
elution
method;
shake
flask
method
Y
44145401
2
830.7950
Vapor
pressure
Y
44107218
2
1
Y
=
Yes;
N
=
No;
N/
A
=
Not
Applicable.
2
D231609,
4/
10/
97,
A.
Smith.
3
The
OPPTS
Series
830,
Product
Properties
Test
Guidelines
require
data
pertaining
to
UV/
visible
absorption
for
the
PAI.
4
Data
are
not
required
because
the
TGAI
is
a
solid
at
room
temperature.
Page
12
of
50
IMAZALIL
REREGISTRATION
ELIGIBILITY
DECISION
RESIDUE
CHEMISTRY
CONSIDERATIONS
PC
Code
No.
111901;
Case
2325
TABLE
OF
CONTENTS
page
INTRODUCTION
.
.
.
.
.
.
.
.
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.
13
REGULATORY
BACKGROUND
.
.
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.
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.
.
.
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.
.
13
SUMMARY
OF
SCIENCE
FINDINGS
.
.
.
.
.
.
.
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.
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.
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.
.
.
.
.
14
GLN
860.1200:
Directions
for
Use
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
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.
.
.
.
14
GLN
860.1300:
Nature
of
the
Residue
­
Plants
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
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.
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.
.
.
16
GLN
860.1300:
Nature
of
the
Residue
­
Livestock
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
17
GLN
860.1340:
Residue
Analytical
Methods
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
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.
.
.
.
21
GLN
860.1360:
Multiresidue
Methods
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
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.
.
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.
.
.
.
.
.
.
.
.
22
GLN
860.1380:
Storage
Stability
Data
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
23
GLN
860.1400:
Water,
Fish,
and
Irrigated
Crops
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
23
GLN
860.1460:
Food
Handling
.
.
.
.
.
.
.
.
.
.
.
.
.
.
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.
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.
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.
.
.
.
.
.
.
.
.
.
.
.
23
GLN
860.1480:
Meat,
Milk,
Poultry,
Eggs
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
24
GLN
860.1500:
Crop
Field
Trials
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
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.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
26
GLN
860.1520:
Processed
Food/
Feed
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
27
GLN
860.1850
and
860.1900:
Confined/
Field
Accumulation
in
Rotational
Crops
.
.
.
.
27
TOLERANCE
REASSESSMENT
SUMMARY
.
.
.
.
.
.
.
.
.
.
.
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.
.
.
.
.
.
.
32
Tolerances
Established
Under
40
CFR
§
180.413
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
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.
.
.
.
.
.
.
33
Tolerances
To
Be
Proposed
Under
40
CFR
§
180.413
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
34
Tolerances
Established
Under
40
CFR
§
180.413(
b)
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
.
34
Pending
Tolerance
Petitions
.
.
.
.
.
.
.
.
.
.
.
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.
.
34
CODEX
HARMONIZATION
.
.
.
.
.
.
.
.
.
.
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.
.
.
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.
.
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.
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.
.
.
.
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.
.
.
.
.
.
.
.
37
AGENCY
MEMORANDA
RELEVANT
TO
REREGISTRATION
.
.
.
.
.
.
.
.
.
.
.
.
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.
.
.
.
.
.
.
38
MASTER
RECORD
IDENTIFICATION
NUMBERS
.
.
.
.
.
.
.
.
.
.
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.
.
.
44
Page
13
of
50
IMAZALIL
REREGISTRATION
ELIGIBILITY
DECISION
RESIDUE
CHEMISTRY
CONSIDERATIONS
PC
Code
No.
111901;
Case
2325
INTRODUCTION
Imazalil
[
1­(
2­(
2,4­
dichlorophenyl)­
2­(
2­
propenyloxy)
ethyl)­
1H­
imidazole]
is
a
systemic
fungicide
registered
for
postharvest
treatment
of
citrus
fruits
and
bananas
(
foreign
use)
and
for
seed
treatment
of
barley
and
wheat
prior
to
planting.
Imazalil's
end­
use
products
are
marketed
by
Janssen
Pharmaceutica
in
the
United
States
under
the
trade
names
Fecundal
®
and
Fungaflor
®
,
and
by
Makhteshim­
Agan
of
North
America
Inc.
as
Magnate
®
,
all
of
which
are
emulsifiable
concentrate
(
EC)
formulations.
Fungaflor
®
and
Magnate
®
are
also
formulated
as
a
soluble
powder
(
SP)
for
use
on
bananas
imported
into
the
United
States
from
Colombia,
Costa
Rica,
Ecuador,
Guatemala,
Honduras,
and
Mexico.
The
reregistration
of
imazalil
is
being
supported
by
Janssen
Pharmaceutica,
and
by
Makhteshim­
Agan
of
North
America
Inc.
(
MANA).

REGULATORY
BACKGROUND
The
Imazalil
Phase
4
Review
of
10/
19/
90
and
the
subsequent
Imazalil
Data­
Call­
In
(
DCI)
Notice
of
12/
31/
90
summarized
the
status
of
available
residue
chemistry
data
for
the
reregistration
of
imazalil.
The
Phase
4
Review
identified
several
data
deficiencies
including
plant
and
livestock
metabolism,
residue
analytical
methods,
storage
stability,
and
magnitude
of
the
residue
in
plants
and
livestock.
Several
studies
have
been
submitted
and
evaluated
in
response
to
the
Imazalil
DCI.
This
document
presents
an
overall
and
up
to
date
Residue
Chemistry
Science
Assessment
with
respect
to
the
reregistration
of
imazalil.

The
established
tolerances
for
plant
commodities
[
40
CFR
§
180.413(
a)]
are
expressed
in
terms
of
the
combined
residues
of
imazalil
and
its
metabolite
R014821
[
1­(
2,4­
dichlorophenyl)­
2­(
1Himidazole
1­
yl)­
1­
ethanol].
Plant
commodity
tolerances
range
from
0.05
ppm
(
barley
grain,
cottonseed,
and
wheat
grain)
to
10
ppm
(
citrus
fruits).
Tolerances
are
also
established
for
the
combined
residues
of
imazalil
and
R014821
in
citrus
oil
and
citrus
dried
pulp,
each
at
25
ppm.
The
established
tolerances
for
livestock
commodities
[
40
CFR
§
180.413(
b)]
are
expressed
in
terms
of
the
combined
residues
of
imazalil
and
its
metabolites
R014821
and
R042243
[
3­[
1­(
2,4­
dichlorophenyl)­
2­(
1H­
imidazole­
1­
yl)
ethoxyl]­
1,2­
propanediol].
Animal
commodity
tolerances
range
from
0.01
ppm
(
milk
and
fat,
meat,
and
meat
byproducts
of
cattle,
goats,
hogs,
horses,
and
sheep)
to
0.50
ppm
(
liver
of
cattle,
goats,
hogs,
horses,
and
sheep).
No
tolerances
are
established
for
eggs
or
poultry
tissues.
Adequate
GC/
ECD
methods
are
listed
in
the
Pesticide
Analytical
Manual
(
PAM),
Vol.
II
for
enforcement
of
imazalil
tolerances,
as
currently
expressed.
Codex
Page
14
of
50
MRLs
for
residues
of
imazalil
in/
on
plant
commodities
are
currently
defined
in
terms
of
imazalil
per
se,
and
as
such
are
not
compatible
with
U.
S.
tolerances.

SUMMARY
OF
SCIENCE
FINDINGS
GLN
860.1200:
Directions
for
Use
According
to
a
REFS
search,
conducted
on
1/
22/
2002,
there
are
three
active
end­
use
products
(
see
Table
A1)
registered
to
Janssen
Pharmaceutica
and
Makhteshim­
Agan
of
North
America
Inc.
(
MANA)
which
contain
the
active
ingredient
imazalil
which
is
registered
for
use
on
domestically
grown
food/
feed
crops
(
i.
e.,
citrus
fruits,
barley,
and
wheat).
There
are
additional
imazalil
enduse
products
registered
for
use
on
imported
bananas
grown
in
Costa
Rica,
Colombia,
Ecuador,
Guatemala,
Honduras,
and
Mexico.
HED
has
examined
translated
imazalil
foreign
labels
(
Fungaflor
®
75
SP
labels)
supplied
by
Janssen
Pharmaceutica.
The
foreign
uses
were
found
to
be
adequate
for
the
purpose
of
assessing
whether
or
not
the
submitted
banana
field
trial
data
reflect
the
maximum
imazalil
residues
of
concern
likely
to
occur
in/
on
bananas.

Table
A1.
Imazalil
End­
Use
Products
with
Food/
Feed
Uses
Registered
to
Janssen
Pharmaceutica
and
to
Makhteshim­
Agan
of
North
America
Inc.

EPA
Reg.
No.
Label
Acceptance
Date
Formulation
Product
Name
43813­
6
9/
9/
85
44.6%
(
4.17
lb/
gal)
EC
Fungaflor
®
500
EC
43813­
14
8/
7/
95
9.5%
(
0.84
lb/
gal)
EC
Fecundal
®
100
EC
66222­
20
8/
23/
01
44.5%
EC
Magnate
®
500
EC
The
above
labels
specify
a
re­
entry
interval
of
48
hours.
There
are
no
rotational
crop
restrictions
specified
on
the
labels.
A
review
of
the
imazalil
labels
and
supporting
residue
data
suggest
those
label
amendments
are
required
to
specify
the
number
of
applications
for
some
registered
crops.
The
9.5%
EC
(
EPA
Reg.
No.
43813­
14)
formulation
should
be
amended
to
specify
a
maximum
of
one
seed
treatment
prior
to
planting
of
fields
with
seed­
treated
barley
and
wheat.
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
basic
producer
labels.

A
comprehensive
summary
of
imazalil
food/
feed
use
patterns,
based
on
the
product
labels
registered
to
Janssen
Pharmaceutica
and
Makhteshim­
Agan
of
North
America
Inc.
(
MANA),
is
presented
in
Table
A2.
A
tabular
summary
of
the
residue
chemistry
science
assessments
for
the
reregistration
of
imazalil
is
presented
in
Table
B.
The
status
of
reregistration
requirements
for
each
guideline
topic
listed
in
Table
B
is
based
on
the
use
patterns
registered
by
the
basic
producers,
Janssen
Pharmaceutica
and
Makhteshim­
Agan
of
North
America
Inc.
(
MANA).
This
chapter
does
not
include
uses
registered
to
other
registrants,
such
as
the
poultry
hatchery
use
registered
to
Schering­
Plough
(
EPA
Reg.
No.
773­
55
and
773­
56)
for
which
no
residue
data
are
available.
Page
15
of
50
Table
A2.
Food/
Feed
Use
Patterns
on
EP
Labels
Subject
to
Reregistration
for
Imazalil
(
Case
2325).

Site
Application
Timing
Application
Type
Application
Equipment
Formulation
[
EPA
Reg.
No.]
Maximum
Single
Application
Rate
Maximum
Number
of
Applications
Per
Season
Maximum
Seasonal
Rate
Preharvest
Interval,
Days
Use
Directions
and
Limitations
Bananas
(
Imported)

Post­
harvest
treatment
Spray,
fog,
dip,
or
drench
Fungaflor
®
75
SP
(
no
U.
S.
registration)
0.07%
of
product
in
water
or
525
ppm
ai
1
(
Implied)
525
ppm
ai
(
Implied)
0
1
The
labels
recommend
that
"
crowns
and
fruit
need
to
be
wetted
carefully
and
thoroughly."

According
to
information
provided
by
Janssen
Pharmaceutica,
spray,
fog,
dip,
or
drench
application
should
be
made
for
3
to
25
seconds.

Barley
and
Wheat
Seed
treatment
Mechanical
slurry
or
misttype
of
seed
treatment
equipment
9.5%
(
0.84
lb/
gal)
EC
[
43813­
14]
1.5
fl.
oz
of
product/
100
lbs
of
seed(
cwt)

or
0.01
lb
ai/
cwt
(
equivalent
to
100
ppm;
mg
ai/
kg
seed)
Not
specified
(
NS)
NS
NS
Treated
seeds
should
be
adequately
dyed,
and
any
dye
added
to
treated
seeds
must
be
cleared
for
use
under
40
CFR
§
180.1001.
Treated
seeds
should
not
be
used
for
food,
feed,
or
oil
purposes.
The
grazing
or
feeding
of
livestock
on
treated
areas
for
six
weeks
after
planting
is
prohibited.

Seed
treatment
Mechanical
slurry
or
misttype
of
seed
treatment
equipment
44.5%

EC
[
66222­
20]
0.34
fl.
oz
of
product/
100
lbs
of
seed(
cwt)
Not
specified
(
NS)
NS
NS
Treated
seeds
should
be
adequately
dyed,
and
any
dye
added
to
treated
seeds
must
be
cleared
for
use
under
40
CFR
§
180.1001.
Treated
seeds
should
not
be
used
for
food,
feed,
or
oil
purposes.
The
grazing
or
feeding
of
livestock
on
treated
areas
for
six
weeks
after
planting
is
prohibited.

Citrus
Fruits
Post­
harvest
treatment
Dips,
wash
tanks,
and
drenches
44.6%
(
4.17
lb/
gal)
EC
[
43813­
6]

and
44.5%

EC
[
66222­
20]
19.2
fl.
oz
of
product/
100
gal
water
or
750
ppm
ai
2
4000ppm
ai
Not
applicable
(
NA)
Application
should
be
made
in
dips,
wash
tanks,

and
drenchers.
Length
of
dip
time
should
not
exceed
2
minutes.

Post­
harvest
treatment
Wax
25.5
fl.
oz
of
product/
100
gal
water
or
1000
ppm
ai
2
(
Should
not
exceed
4000
ppm
total)
*
or*

1
application
of
4000ppm
in
wax
4000ppm
ai
NA
Application
should
be
made
to
freshly
cleaned
fruits
immediately
prior
to
waxing.

Post­
harvest
treatment
Spray
brush
25.5
fl.
oz
of
product/
100
gal
water
or
1000
ppm
ai
2
4000ppm
ai
NA
Application
should
be
made
after
washing
and
prior
to
wax
application.

Post­
harvest
treatment
Foamer
51.0
fl.
oz
of
product/
100
gal
water
or
2000
ppm
ai
2
4000ppm
ai
NA
Application
should
be
made
as
a
ready­
to­
use
foam
detergent
using
a
mechanical
foamer.
Page
16
of
50
Cl
Cl
O
N
N
CH
2
1
A
0­
day
PHI
has
been
established
for
Costa
Rica,
Guatemala,
Honduras,
and
Mexico;
however,
pre­
harvest
foliar
application
of
imazalil
is
not
registered
for
use
on
bananas
at
this
time.

GLN
860.1300:
Nature
of
the
Residue
­
Plants
The
reregistration
requirements
for
plant
metabolism
are
fulfilled.
Acceptable
metabolism
studies,
reflecting
post­
harvest
treatment
of
imazalil
on
bananas
and
oranges
as
well
as
seed
treatment
of
imazalil
on
wheat,
were
conducted.
In
all
studies,
the
parent
was
the
predominant
residue
identified
in/
on
whole
bananas
(­
69­
82%
of
the
total
radioactive
residues
or
TRR),
banana
pulps
(­
68­
82%
TRR),
orange
fruits
(­
75%
TRR),
wheat
forage
(­
24%
TRR),
and
wheat
straw
(­
17%
TRR).
The
total
radioactivity
in
wheat
grain,
grown
from
wheat
seeds
treated
with
[
14C]
imazalil
at
5x
the
maximum
label
rate,
was
#
0.004
ppm
and
were
not
further
characterized.
The
metabolite
R014821
was
identified
as
a
minor
component
in/
on
banana,
whole
and
pulp
(<
5%
TRR),
orange
fruits
(­
3­
6%
TRR),
wheat
forage
(­
8%
TRR),
and
wheat
straw
(­
4%
TRR).
Several
additional
metabolites
containing
the
2,4­
dichlorophenyl
group
were
identified
in
analyzed
commodities
but
they
were
detected
at
relatively
low
(#
5%
TRR)
levels.
The
established
tolerances
for
plant
commodities
are
currently
expressed
in
terms
of
the
combined
residues
of
imazalil
and
its
metabolite
R014821.
HED
concludes
that
the
existing
tolerance
expression
for
plant
commodities
is
appropriate
for
the
purpose
of
reregistration.
The
chemical
structures
and
chemical
names
of
these
regulated
compounds
are
depicted
in
Figure
A.

Figure
A.
Chemical
Names
and
Structures
of
Imazalil
Residues
of
Concern
in
Plant
Commodities.

Compound
Chemical
Structure
Common
Name:
Imazalil
Janssen
Research
Code:
R023979
Chemical
Name:
1­[
2­(
2,4­
dichlorophenyl)­
2­(
2­
propenyloxy)
ethyl]­
1H­
imidazole
Compound
Chemical
Structure
Page
17
of
50
Cl
Cl
OH
N
N
Common
Name:
Despropenyl
imazalil;
ethanol
metabolite
Metabolite
Designation(
s):
R014821;
FK411
Chemical
Name:
1­[
2,4­
dichlorophenyl)­
2­(
1H­
imidazole­
1­
yl]­
1­
ethanol
GLN
860.1300:
Nature
of
the
Residue
­
Livestock
The
reregistration
requirements
for
livestock
metabolism
are
fulfilled
based
on
acceptable
goat
and
poultry
metabolism
studies.
These
studies
indicate
that
imazalil
is
extensively
metabolized
in
goat
and
hen.
Only
six
common
metabolites
(
out
of
about
twenty
identified)
were
found
in
both
goat
and
hen.
Radioactive
residue
levels
in
hen
eggs
and
tissues
were
<
0.01
ppm
(
except
0.028
ppm
in
liver)
when
the
exaggerated
dose
was
taken
into
consideration.
When
normalized
to
the
expected
dietary
burden,
residue
levels
in
the
goat
ranged
from
0.015
ppm
to
3.3
ppm
in
milk
and
tissues.
The
results
of
these
studies
were
presented
to
the
HED
Metabolism
Committee
(
L.
Cheng,
8/
30/
94),
and
members
of
the
Committee
were
asked
whether
the
current
tolerance
expression
for
livestock
commodities
should
remain
unchanged
or
whether
separate
tolerance
expressions
should
be
set
for
ruminant
and
poultry,
and
which
metabolites
should
require
regulation
in
each
case.

The
Committee
concluded
that
(
L.
Cheng,
8/
30/
94),
in
the
absence
of
information
to
the
contrary,
any
metabolite
containing
the
2,4­
dichlorophenyl
moiety
is
of
toxicological
concern,
and
must
be
included
in
the
dietary
risk
assessment.
The
Committee
also
concluded
that
HED
should
define
a
list
of
metabolites
containing
this
moiety
which
should
be
analyzed
in
livestock
feeding
studies
and
explicitly
included
in
the
tolerance
expression.
These
metabolites
together
with
the
parent
compound
should
serve
as
marker
compounds
which
should,
using
the
metabolite
ratios
found
in
the
metabolism
studies,
be
used
to
determine
residue
values
for
dietary
risk
assessment.
It
would
be
assumed
that
only
metabolites
identified
in
the
metabolism
study
as
having
the
2,4­
dichlorophenyl
moiety
constitute
the
residue
to
be
included
in
risk
assessment.

The
registrant
is
now
pursuing
the
development
of
a
new
GC/
ECD
method
capable
of
quantifying
residues
of
imazalil
and
appropriate
marker
compounds
that
account
for
a
high
percentage
of
the
total
toxic
residues
in
livestock
commodities;
see
"
Residue
Analytical
Methods"
section.
The
marker
compounds
in
milk
and
ruminant
tissues
are
imazalil,
FK772,
and
FK284
which
collectively
represent
the
following
percentages
of
the
total
toxic
residues,
as
determined
by
the
ruminant
metabolism
studies:
21%
in
milk,
72%
in
muscle,
71%
in
kidney,
44%
in
liver,
and
33%
Page
18
of
50
in
fat.
The
marker
compounds
in
eggs
and
poultry
tissues
are
imazalil,
FK858,
and
FK326
or
FK259
which
collectively
represent
the
following
percentages
of
the
total
toxic
residues,
as
determined
by
the
poultry
metabolism
studies:
69%
in
eggs,
45%
in
liver,
52%
in
fat,
and
100%
in
muscle.
The
chemical
names
and
structures
of
imazalil
and
marker
metabolites
in
livestock
commodities
are
depicted
in
Figures
B
(
milk
and
ruminant
tissues)
and
C
(
eggs
and
poultry
tissues).
Page
19
of
50
Cl
Cl
O
N
N
CH
2
Cl
Cl
O
N
H
N
OH
OH
O
O
Cl
Cl
OH
N
H
N
O
O
Figure
B.
Chemical
Names
and
Structures
of
Imazalil
and
Marker
Metabolites
In
Milk
and
Ruminant
Tissues.

Compound
Chemical
Structure
Common
Name:
Imazalil
Janssen
Research
Code:
R023979
Chemical
Name:
1­[
2­(
2,4­
dichlorophenyl)­
2­(
2­
propenyloxy)
ethyl]­
1H­
imidazole
Metabolite
Designation
in
Goat
Metabolism
Study:
FK772
Janssen
Research
Code:
R061000
Chemical
Name:
3­[
2­(
2,4­
dichlorophenyl)­
2­(
2,3­
dihydroxypropoxy)
ethyl]­
2,4­
imidazolidinedione
Metabolite
Designation
in
Goat
Metabolism
Study:
FK284
Janssen
Research
Code:
R042449
or
R043449
Chemical
Names:
3­(
2­(
2,4­
dichlorophenyl)­
2­(
hydroxy)­
2,4­
imidazolidinedione
or
1­[
2­(
2,4­
dichlorophenyl)­
2­
hydroxyethyl]­
2,4­
imidazolidinedione
Page
20
of
50
(
continued
next
page)
Cl
Cl
O
N
N
CH
2
Cl
Cl
O
N
N
OH
OH
Cl
Cl
OH
NH
N
H
2
O
Figure
C.
Chemical
Names
and
Structures
of
Imazalil
and
Marker
Metabolites
In
Eggs
and
Poultry
Tissues.

Compound
Chemical
Structure
Common
Name:
Imazalil
Janssen
Research
Code:
R023979
Chemical
Name:
1­[
2­(
2,4­
dichlorophenyl)­
2­(
2­
propenyloxy)
ethyl]­
1H­
imidazole
Metabolite
Designation
in
Poultry
Metabolism
Study:
FK858
Janssen
Research
Code:
R042639
or
bishydroxylated
imazalil
Chemical
Names:
3­[
1­(
2,4­
dichlorophenyl)­
2­(
1H­
imidazole­
1­
yl)
ethoxy]­
1,2­
propanediol
or
1­[
2­(
2,4­
dichlorophenyl)­
2­(
2,3­
dihydroxypropoxy)
ethyl]­
1H­
imidazole
Metabolite
Designation
in
Poultry
Metabolism
Study:
FK326
Janssen
Research
Code:
R044085
Chemical
Name:
(
±
)
­
N­[
2­(
2,4­
dichlorophenyl)­
2­
hydroxyethyl]
urea
Figure
C
(
continued).

Compound
Chemical
Structure
Page
21
of
50
Cl
Cl
OH
N
H
2
Metabolite
Designation
in
Poultry
Metabolism
Study:
FK259
Janssen
Research
Code:
R018238
Chemical
Name:
1­(
2,4­
dichlorophenyl)­
2­
aminoethanol
GLN
860.1340:
Residue
Analytical
Methods
An
adequate
residue
analytical
method
is
available
for
determining
the
total
toxic
residues
of
imazalil
in/
on
plant
commodities
but
not
in
livestock
commodities.

Method
for
determination
of
residues
in/
on
plant
commodities:
The
Pesticide
Analytical
Manual
(
PAM)
Volume
II
lists
a
GC/
ECD
method,
designated
as
Method
I,
for
the
quantitation
of
residues
of
imazalil
and
its
metabolite
R014821
in/
on
bananas,
citrus
fruits,
cottonseed,
and
small
grains.
Briefly,
residues
are
extracted
from
plant
samples
with
heptane:
isoamyl
alcohol
(
95:
5,
v:
v),
partitioned
into
0.1
N
H
2
SO
4
,
and
re­
extracted
from
alkaline
solution
into
heptane:
isoamyl
alcohol
(
95:
5,
v:
v).
The
extract
is
evaporated
to
dryness,
and
N,
O­
bis(
trimethylsilyl)
acetamide
is
added
to
convert
the
metabolite
to
the
trimethylsilyl
derivative.
Imazalil
and
the
derivatized
metabolite
are
determined
separately
by
GC
with
electron
capture
detection
from
a
single
injection
of
the
derivative
solution.
The
limits
of
detection
range
from
0.01­
0.05
ppm,
depending
on
the
plant
matrix.
Plant
commodity
samples
collected
from
studies
pertaining
to
magnitude
of
the
residues
in
plant
were
analyzed
for
residues
of
imazalil
and
its
metabolite
R014821
using
this
PAM
Volume
II
method
or
its
modification;
in
these
field
studies,
method
recoveries
obtained
from
concurrent
analyses
of
treated
samples
were
acceptable.
This
enforcement
method
has
been
adequately
radio­
validated
using
samples
from
the
banana
metabolism
study.

Methods
for
determination
of
residues
in
livestock
commodities:
The
PAM
Volume
II
also
lists
a
GC/
ECD
method,
designated
as
Method
II,
for
the
quantitation
of
residues
of
imazalil
and
the
metabolites
R014821
and
R042243.
The
limits
of
detection
range
from
0.01
to
0.05
ppm,
depending
on
the
specific
matrix.
Method
II
also
involves
the
conversion
of
the
metabolites
to
the
trimethylsilyl
derivatives
and
separate
determination
of
imazalil
and
the
derivatized
metabolites.
It
should
be
noted
that
this
method
is
not
a
precise
measure
of
the
total
toxic
imazalil
residues
in
meat,
milk,
poultry,
and
eggs,
as
determined
by
the
results
of
livestock
metabolism
studies.
Page
22
of
50
Because
of
the
recommended
changes
in
tolerance
expression,
a
new
enforcement
method
capable
of
determining
imazalil
and
any
metabolite
containing
the
2,4­
dichlorophenyl
group
in
livestock
commodities
is
required.
To
accomplish
this,
HED
suggested
that
the
registrant
develop
an
enforcement
method
capable
of
measuring
all
compounds
containing
the
2,4­
dichlorophenyl
group
using
a
method
which
converts
these
residues
to
a
common
moiety.
Alternatively,
the
registrant
was
given
the
option
of
developing
an
enforcement
method
for
a
set
of
marker
compounds
that
account
for
a
high
percentage
of
the
total
toxic
residues
in
ruminant
and
poultry.

Attempts
by
the
registrant
to
develop
a
common
moiety
method,
based
on
the
oxidation
of
imazalil
and
five
of
its
metabolites
to
2,4­
dichlorobenzoic
acid,
were
unsuccessful
due
to
extraction
inefficiency
and
method
recovery
variability.
The
registrant
is
now
pursuing
the
development
of
a
new
GC/
ECD
method
capable
of
quantitating
residues
of
imazalil
and
the
appropriate
marker
metabolites.
Preliminary
validation
data
indicate
that
the
proposed
GC/
ECD
method
is
adequate
for
collecting
data
on
residues
of
imazalil,
FK772,
and
FK284
in
milk
and
ruminant
tissues,
provided
fortified
control
samples
are
analyzed
concurrently
with
each
set
of
treated
samples
to
assure
that
acceptable
method
recoveries
are
being
achieved
for
each
analysis;
independent
laboratory
validation
must
be
conducted
prior
to
the
method
being
sent
to
the
Agency
for
validation
as
an
enforcement
method.
This
method
was
used
in
the
analysis
of
samples
collected
from
a
recently
reviewed
ruminant
feeding
study.

For
the
purpose
of
reregistration,
the
registrant
must
continue
to
develop/
validate
enforcement
method(
s)
for
a
set
of
marker
compounds
that
account
for
a
high
percentage
of
the
total
toxic
residues
in
ruminant
and
poultry.
HED
will
correct
residues
to
account
for
the
total
toxic
residue
for
the
purpose
of
tolerance
reassessment
as
well
as
for
dietary
risk
exposure
assessment.

GLN
860.1360:
Multiresidue
Methods
The
2/
97
FDA
PESTDATA
database
(
PAM
Volume
I,
Appendix)
indicates
that
the
parent
imazalil
is
completely
recovered
(>
80%)
using
Multiresidue
Methods
Section
302
(
Luke
Method;
Protocol
D)
but
is
not
recovered
using
Multiresidue
Methods
Sections
303
(
Mills,
Onley,
and
Gaither;
Protocol
E,
nonfatty)
and
304
(
Mills,
fatty
food).

Multiresidue
methods
data
have
not
been
submitted
for
imazalil
metabolites
that
warrant
inclusion
in
the
tolerance
expression.
To
fully
satisfy
reregistration
requirements,
the
following
metabolites
must
be
tested
through
FDA's
multiresidue
protocols:
(
I)
metabolite
R014821;
(
ii)
marker
metabolites
in
milk
and
ruminant
tissues
(
FK772
and
FK284);
and
(
iii)
marker
metabolites
in
eggs
and
poultry
tissues
(
FK858,
and
FK326
or
FK259).
The
registrant
is
required
to
follow
the
directions
for
the
protocols
found
in
PAM
Volume
I,
Appendix
II
starting
with
the
decision
tree
for
multiresidue
methods
testing
and
the
accompanying
guidance
found
in
the
suggestions
for
producing
quality
data;
i.
e.
decisions
on
what
protocols
to
follow
and
proper
application
of
methods.
If
the
decision
tree
indicates
that
recovery
is
likely,
the
registrant
should
consult
the
data
development
section
of
the
proper
protocols
and
follow
the
guidance
offered
precisely
to
generate
quality
data.
Page
23
of
50
GLN
860.1380:
Storage
Stability
Data
The
reregistration
requirements
for
storage
stability
data
are
satisfied.
Adequate
storage
stability
data
for
plant
and
livestock
commodities
have
been
submitted
and
evaluated.

Plant
commodities:
Several
storage
stability
studies
have
been
submitted
and
evaluated.
These
studies
showed
that
residues
of
imazalil
and
its
metabolite
R014821
are
stable
under
frozen
storage
conditions
in/
on:
(
I)
bananas
for
up
to
38
weeks;
(
ii)
citrus
fruits
and
their
processed
commodities
for
up
to
34
weeks;
and
(
iii)
wheat
grain
and
forage
for
up
to
24
weeks.
These
storage
stability
data
are
adequate
to
validate
the
storage
intervals
and
conditions
of
samples
collected
from
respective
field
and
processing
studies.
It
should
be
noted
that
HED
previously
concluded
that
residues
of
imazalil
and
its
metabolite
R014821
can
decline
significantly
in/
on
wheat
straw
(­
30­
40%)
over
relatively
short
(­
12­
24
weeks)
periods
of
time.
However,
reanalysis
of
treated
wheat
grain
and
straw
samples
collected
during
field
trials
indicate
that
residues
are
stable
in
these
wheat
RACs
for
at
least
300
days.

Livestock
commodities:
Storage
stability
data,
submitted
in
support
of
the
goat
metabolism
study,
are
adequate
and
indicate
that
radioactive
residues
of
imazalil
in
the
aqueous
extracts
of
milk,
liver,
and
kidney
are
stable
under
frozen
storage
conditions
for
up
to
15
months.
No
storage
stability
data
were
submitted
in
support
of
the
hen
metabolism
study;
however,
analysis
of
egg
and
tissue
samples
collected
from
the
hen
metabolism
study
were
completed
within
six
months
of
sampling.
Samples
collected
from
the
ruminant
feeding
studies
were
stored
frozen
for
30
days
prior
to
residue
analysis.

GLN
860.1400:
Water,
Fish,
and
Irrigated
Crops
Imazalil
is
presently
not
registered
for
direct
use
on
water
and
aquatic
food
and
feed
crops;
therefore,
no
residue
chemistry
data
are
required
under
these
guideline
topics.

GLN
860.1460:
Food
Handling
Imazalil
is
presently
not
registered
for
use
in
food­
handling
establishments;
therefore,
no
residue
chemistry
data
are
required
under
this
guideline
topic.

GLN
860.1480:
Meat,
Milk,
Poultry,
Eggs
Ruminants:
The
reregistration
requirements
for
data
depicting
the
magnitude
of
imazalil
residues
of
concern
in
milk
and
tissues
of
ruminants
are
fulfilled.
An
acceptable
ruminant
feeding
study
has
been
submitted
and
the
maximum
theoretical
dietary
intake
of
imazalil
derived
from
existing
or
proposed
tolerances
has
been
calculated.
As
determined
by
HED,
the
beef
and
dairy
cattle
diets
consisting
of
citrus
pulp,
wheat
straw,
wheat
grain,
and
wheat
forage
would
result
in
burdens
of
about
6.7
ppm
and
4.7
ppm
in
the
diets
of
dairy
cattle
and
beef
cattle,
respectively.
Page
24
of
50
In
the
ruminant
feeding
study,
dairy
cows
were
fed
imazalil
placed
into
gelatin
capsules
and
administered
by
balling
gun
twice
daily
for
28
consecutive
days
at
feeding
levels
of
33
ppm,
99
ppm,
and
330
ppm.
At
the
feeding
level
of
33
ppm,
the
maximum
combined
residues
of
imazalil
and
the
marker
metabolites
FK772
and
FK284
were
0.054
ppm
in
milk,
0.050
ppm
in
muscle,
0.956
ppm
in
liver,
0.155
ppm
in
kidney,
and
0.026
ppm
in
fat.
Presently
the
dietary
burden
does
not
contain
wet
apple
pomace
as
the
previous
chemistry
chapter
did.
The
Chemistry
files
indicate
the
apple
tolerance
petition
was
withdrawn
by
the
registrant.
The
33
ppm
feeding
level
is
now
5x
and
7x
the
dairy
and
beef
cattle
dietary
burden,
respectively.
The
reassessed
tolerances
for
livestock
commodities
are
presented
in
Table
C.

Hogs:
Secondary
residues
of
imazalil
in
hog
fall
under
CFR
180.6
(
a)(
3),
since
there
is
no
reasonable
expectation
of
finite
residues.
There
is
no
reasonable
expectation
of
residues
because
guidance
does
not
support
hogs
feeding
on
citrus
dried,
pulp
and
therefore
tolerances
are
recommended
to
be
revoked.

Maximum
residues
of
imazalil
in
the
diet
of
dairy
cattle
Feed
Item
Proposed
Tolerance
(
ppm)
%
Dry
Matter
%
Livestock
Diet
Dietary
Burden
(
ppm)

protein
source
(
soybeans)
na
na
20
0
citrus
pulp,
dried
25
91
20
5.5
wheat
forage
0.5
25
60
1.2
TOTAL
100
6.7
Maximum
residues
of
imazalil
in
the
diet
of
beef
cattle
Feed
Item
Proposed
Tolerance
(
ppm)
%
Dry
Matter
%
Livestock
Diet
Dietary
Burden
(
ppm)

citrus
pulp,
dried
25
91
15
4.1
protein
source
(
soybeans)
na
na
20
0
wheat
forage
0.5
25
20
0.4
wheat
straw
0.5
88
30
0.18
wheat
grain
0.05
89
15
0.01
TOTAL
100
4.7
Page
25
of
50
Residues
of
Imazalil
and
its
Metabolites
in
Raw
Milk
from
Cows
Fed
Imazalil
for
28
Days.

Imazalil
Feeding
Concentration
(
ppm)
Milk
Sampling
Day
Imazalil
Range
(
ppm)
FK772
ref.
B
FK284
ref.
C
Total
Residue
Range
(
ppm)

330
ppm
(
49x)
1
0.010­
0.029
0.013­
0.020
0.017­
0.063
0.040­
0.112
3
0.092­
0.158
0.021­
0.031
0.166­
0.209
0.279­
0.298
7
0.067­
0.078
0.041­
0.055
0.134­
0.180
0.242­
0.313
15
0.042­
0.057
0.033­
0.049
0.092­
0.167
0.167­
0.273
22
0.025­
0.028
0.026­
0.030
0.086­
0.127
0.137­
0.185
28
0.002­
0.016
0.017­
0.020
0.053­
0.084
0.072­
0.120
99
ppm
(
15x)
1
0.003­
0.012
0.002­
0.004
0.002­
0.008
0.007­
0.024
3
0.011­
0.031
0.011­
0.013
0.024­
0.049
0.046­
0.093
7
0.013­
0.021
0.016­
0.017
0.030­
0.033
0.059­
0.071
13
0.007­
0.009
0.006­
0.008
0.020­
0.032
0.033­
0.049
20
0.006­
0.007
0.011­
0.017
0.010­
0.017
0.027­
0.041
28
0.000­
0.005
0.015­
0.021
0.013­
0.028
0.028­
0.054
33
ppm
(
5x)
1
0.011­
0.015
0.002­
0.003
0.000­
0.001
0.013­
0.019
3
0.008­
0.013
0.007­
0.010
0.000­
0.001
0.015­
0.024
7
0.007­
0.017
0.002­
0.005
0.004­
0.007
0.013­
0.029
14
0.006­
0.010
0.002­
0.004
0.001­
0.006
0.009­
0.020
21
0.005­
0.007
0.007­
0.008
0.003­
0.005
0.015­
0.020
28
0.005­
0.016
0.002­
0.021
0.008­
0.017
0.015­
0.054
Residues
of
Imazalil
and
its
Metabolites
in
Ruminant
Tissues
from
Cows
Fed
Imazalil
for
28
Days.

Imazalil
Feeding
Concentration
(
ppm)
Tissue
Imazalil
Range
(
ppm)
Ref.
B
(
FK
772)
Ref.
C
(
FK284)
Total
Residue
Range
(
ppm)

330
ppm
(
70x)
Muscle
0.003­
0.023
0.015­
0.071
0.074­
0.105
0.092­
0.199
Liver
7.534­
12.253
0.622­
0.895
0.816­
1.535
8.972­
14.683
Kidney
0.606­
1.453
0.633­
1.298
0.355­
1.076
1.594­
3.827
Fat
0.067­
0.224
0.032­
0.043
0.014­
0.083
0.113­
0.350
Imazalil
Feeding
Concentration
(
ppm)
Tissue
Imazalil
Range
(
ppm)
Ref.
B
(
FK
772)
Ref.
C
(
FK284)
Total
Residue
Range
(
ppm)

Page
26
of
50
99
ppm
(
21x)
Muscle
0.000­
0.017
0.005­
0.017
0.017­
0.043
0.022­
0.077
Liver
1.380­
2.759
0.164­
0.514
0.165­
0.440
1.709­
3.713
Kidney
0.153­
0.271
0.191­
0.285
0.038­
0.072
0.382­
0.628
Fat
0.004­
0.014
0.004­
0.032
0.002­
0.021
0.010­
0.067
33
ppm
(
7x)
Muscle
0.001­
0.014
0.002­
0.014
0.000­
0.022
0.003­
0.050
Liver
0.142­
0.506
0.072­
0.229
0.107­
0.221
0.321­
0.956
Kidney
0.006­
0.035
0.055­
0.090
0.000­
0.030
0.061­
0.155
Fat
0.000­
0.014
0.000­
0.007
0.000­
0.005
0.000­
0.026
Poultry:
HED
has
made
a
determination
to
not
require
tolerances
for
imazalil
residues
of
concern
in
eggs
and
poultry
tissues
since
there
is
no
reasonable
expectation
of
finite
residues
[
40
CFR
§
180.6(
a)(
3)].
This
determination
is
based
on
a
review
of
a
poultry
feeding
study(
DP
barcode
D254805,
D.
Hrdy,
1/
19/
00.)
However,
a
determination
of
tolerances
resulting
from
a
fumigation
application
has
not
yet
been
made
and
remains
a
data
gap
(
see
773­
EUP­
R,
memo
of
8/
12/
85,
A.
Reiter
and
S.
Hummel).

GLN
860.1500:
Crop
Field
Trials
The
reregistration
requirements
for
data
depicting
the
magnitude
of
imazalil
and
its
metabolite
R014821
in/
on
the
following
raw
agricultural
commodities
(
RACs)
are
fulfilled:
bananas,
barley
grain,
barley
straw,
citrus
fruits,
wheat
grain,
wheat
forage,
and
wheat
straw.
Except
for
the
grains
of
barley
and
wheat,
the
available
crop
field
trials
reflecting
use
of
registered
formulations
at
1x
the
maximum
label
rate
showed
finite
residues
of
imazalil
and
its
metabolite
R014821
in/
on
the
RACs
of
crops
for
which
registration
exists.

The
Agency
has
updated
the
list
of
raw
agricultural
and
processed
commodities
and
feedstuffs
derived
from
crops
(
Table
1,
OPPTS
GLN
860.1000).
Table
1
now
lists
hay
as
a
RAC
of
barley,
and
barley
forage
was
removed
as
a
RAC.
No
data
for
barley
hay
have
been
submitted.
However,
the
available
data
for
barley
forage
and
straw
will
be
translated
to
barley
hay.

Table
1
also
lists
wheat
hay
as
a
RAC
of
wheat,
and
no
data
for
wheat
hay
have
been
submitted.
The
available
data
for
wheat
forage
and
straw
will
be
translated
to
wheat
hay.
Residue
data
for
wheat
aspirated
grain
fractions
are
not
required
because
imazalil's
registered
use
on
wheat
is
limited
to
seed
treatment,
which
typically
does
not
trigger
data
requirement
for
aspirated
grain
fractions.
(
continued;
footnotes
follow)
Page
27
of
50
There
are
no
registered
uses
of
imazalil
on
cottonseed
for
which
a
tolerance
is
established.
To
date,
no
registrants
have
committed
to
support
imazalil
use
on
cottonseed.
Unless,
Janssen
Pharmaceutica
or
other
registrants
submit
supporting
residue
data,
HED
will
recommend
for
tolerance
revocation.

GLN
860.1520:
Processed
Food/
Feed
The
reregistration
requirements
for
studies
pertaining
to
the
magnitude
of
the
residue
in
the
processed
commodities
of
citrus
fruits
are
fulfilled.
Acceptable
citrus
processing
studies,
reflecting
post­
harvest
treatments
and
conducted
according
to
commercial
practice,
were
separately
conducted
on
grapefruit,
oranges,
and
lemons.
Citrus
fruits
were
treated
with
imazalil
in
a
wax
formulation
at
1x
and
2x
the
maximum
registered
label
rates.
The
studies
showed
that
residues
of
imazalil
and
its
metabolite
R014821
do
not
concentrate
in
juice;
the
combined
residues
reduced
by
­
90%
in
citrus
juice.
However,
residues
of
imazalil
and
its
metabolite
R014821
do
concentrate
in
dried
pulp
and
oil.
In
dried
pulp,
the
maximum
average
concentration
factor
of
total
residues
in
oranges
was
2.5x;
the
overall
average
concentration
factor
of
total
residues
for
the
three
citrus
crops
was
1.7x.
In
oil,
the
average
concentration
of
total
residues
was
3.3x
in
lemon,
15.0x
in
grapefruit,
and
28.0x
in
oranges;
the
overall
average
concentration
factor
in
oil
for
the
three
citrus
crops
was
16.0x.
Refer
to
"
Tolerance
Reassessment
Summary"
section
for
recommendations
with
respect
to
the
need
for
tolerances
as
a
result
of
concentration
of
residues
in
citrus
processed
commodities.

HED
has
earlier
concluded
that
barley
and
wheat
grain
processing
studies
are
not
required.
This
determination
was
based
on
the
theoretical
concentration
factors
for
barley
and
wheat
grain
processed
commodities
(
1.2­
9x),
the
apparent
residues
<
LOQ
from
the
use
of
exaggerated
application
rates
(
6.3x
and
10x),
and
the
use
pattern
(
seed
treatment),
which
is
unlikely
to
result
in
surface
residues
on
the
grain.
The
combined
residues
of
imazalil
and
its
metabolite
R014821
in/
on
barley
and
wheat
processed
commodities
are
not
likely
to
exceed
the
reassessed
tolerances
for
barley
and
wheat
grains.

GLN
860.1850
and
860.1900:
Confined/
Field
Accumulation
in
Rotational
Crops
Confined
and/
or
field
accumulation
studies
are
not
required
because
the
use
of
imazalil
on
annual
crops
(
represented
by
barley
and
wheat)
eligible
for
reregistration
is
limited
to
seed
treatment
prior
to
crop
planting.
Furthermore,
the
available
plant
metabolism
data
indicate
that
the
total
radioactivity
in
wheat
grain,
grown
from
wheat
seeds
treated
with
[
14C]
imazalil
at
5x
the
maximum
label
rate,
was
#
0.004
ppm.
HED
does
not
anticipate
uptake
of
imazalil
residues
of
concern
in/
on
rotational
crops
when
registered
formulations
of
imazalil
are
applied
to
primary
crops
according
to
the
maximum
registered
use
patterns.
No
specific
rotational
crop
restrictions
should
be
imposed
at
this
time.

Table
B.
Residue
Chemistry
Science
Assessments
for
Reregistration
of
Imazalil.
Table
B
(
continued).

(
continued;
footnotes
follow)
Page
28
of
50
GLN:
Data
Requirements
Current
Tolerances,
ppm
[
40
CFR]
Must
Additional
Data
Be
Submitted?
References
1
860.1200:
Directions
for
Use
Not
applicable
(
N/
A)
Yes
2
See
Tables
A1
and
A2
860.1300:
Plant
Metabolism
N/
A
No
00027532,
00087542,
00087543,
00096418,
00157188,
42012006
3,
42012007
3,
42012008
4,
42012009
4,
42403102
5,
42626901
6,
43308401
7,
43965701
8,
92072019,
92072020,
92072035,
92072036,
92072037
860.1300:
Livestock
Metabolism
N/
A
No
00027533,
00084644,
42012005
3,
42454801
9,
42454802
9,
42593602
9,
42838201
10,
4294940111,
43076101
12,
92072021,
92072038
860.1340:
Residue
Analytical
Methods
­
Plant
commodities
N/
A
No
00109269,
00127900,
42454803
13,
42454804
13,
42454805
13,
42626902
6,
44532901
14,
92072022,
92072023
­
Livestock
commodities
N/
A
Yes
15
00109269,
44337701
16,
44455601
17,
92072024
860.1360:
Multiresidue
Methods
N/
A
Yes
18
FDA
PESTDATA
database
(
PAM
Volume
I,
Appendix)

860.1380:
Storage
Stability
Data
­
Plant/
processed
commodities
N/
A
No
00157189,
42626903
6,
42643301
19,
4275530120
,
92072025
­
Livestock
commodities
N/
A
No
42838201
10
860.1500:
Crop
Field
Trials
Citrus
Fruits
Group
10.0
[
§
180.413(
a)]
No
40509402,
40509403,
92072027,
92072030
21,
92072040
21
Cereal
Grains
Group
­
Barley,
grain
0.05
[
§
180.413(
a)]
No
00127900,
00150020,
00157190,
42852001
22,
92072026,
92072042
­
Wheat,
grain
and
aspirated
grain
fractions
0.05
[
§
180.413(
a)]
No
23
00127900,
00157190,
42852002
22,
42868101
22,
43285001
24,
92072029,
920722041
Fodder,
Forage,
Hay,
and
Straw
of
Cereal
Grains
Group
Table
B
(
continued).
GLN:
Data
Requirements
Current
Tolerances,
ppm
[
40
CFR]
Must
Additional
Data
Be
Submitted?
References
1
Page
29
of
50
1.
Bolded
references
were
evaluated
in
the
Imazalil
Phase
4
Review
(
S.
Funk,
10/
19/
90).
All
other
references
were
reviewed
as
noted.
­
Barley,
hay
and
straw
0.5,
forage
and
straw
[
§
180.413(
a)]
No
25
00127900,
00150020,
00157190,
42852001
22,
92072026,
92072042
­
Wheat,
forage,
hay,
and
straw
0.5,
forage
and
straw
[
§
180.413(
a)]
No
26
00127900,
00157190,
42852002
22,
42868101
22,
43285001
24,
92072029,
920722041
Miscellaneous
Commodities
­
Bananas
3.0,
whole;
0.2,
pulp
[
§
180.413(
a)]
No
42058701
27,
42710501
28
­
Cotton,
seed
and
gin
byproducts
0.05,
cottonseed
[
§
180.413(
a)]
No
29
00127900,
92072028,
92072039
860.1520:
Processed
Food/
Feed
­
Barley
0.05,
grain
[
§
180.413(
a)]
No
30
­
Citrus
10.0,
citrus
fruits
[
§
180.413(
a)];
25.0,
citrus
oil
[
§
185.3650];
25.0,
citrus
dried
pulp
[
§
186.3650]
No
40509403,
42348301
31,
42405501
31,
42454806
32,
92072040
21
­
Wheat
0.05,
grain
[
§
180.413(
a)]
No
30
860.1480:
Meat,
Milk,
Poultry,
Eggs
­
Milk
and
the
Fat,
Meat,
and
Meat
Byproducts
of
Cattle,
Goats,
Hogs,
Horses,
and
Sheep
0.01,
milk,
fat,
meat,
mbyp;
0.5,
liver
[
§
180.413(
b)]
No
00079192,
00079193,
00109269,
44568301
33
­
Eggs
and
the
Fat,
Meat,
and
Meat
Byproducts
of
Poultry
§
180.6(
a)
3
Yes34
860.1400:
Water,
Fish,
and
Irrigated
Crops
N/
A
N/
A
860.1460:
Food
Handling
N/
A
N/
A
860.1850:
Confined
Rotational
Crops
N/
A
No
860.1900:
Field
Rotational
Crops
None
established
No
Table
B
(
continued).

Page
30
of
50
2.
The
9.5%
EC
(
EPA
Reg.
No.
43813­
14)
formulation
of
imazalil
should
be
amended
to
specify
a
maximum
of
one
seed
treatment
prior
to
planting
of
fields
with
seed­
treated
barley
and
wheat.
3.
DP
Barcode
D171401,
2/
4/
92,
L.
Cheng.

4.
DP
Barcode
D198235,
5/
3/
94,
L.
Cheng.

5.
DP
Barcode
D181284,
9/
25/
92,
L.
Cheng.

6.
DP
Barcode
D187506,
1/
10/
94,
L.
Cheng.

7.
DP
Barcode
D205954,
9/
22/
94,
L.
Cheng.

8.
DP
Barcode
D224876,
6/
12/
96,
L.
Cheng.

9.
DP
Barcodes
D182706
and
D186541,
2/
17/
93,
J.
Abbotts.

10.
DP
Barcode
D193375,
8/
17/
93,
J.
Abbotts.

11.
DP
Barcode
D195726,
11/
17/
93,
S.
Funk.

12.
DP
Barcode
D198599,
7/
14/
94,
L.
Cheng.

13.
DP
Barcode
D182707,
6/
24/
93,
S.
Funk.

14.
DP
Barcode
245510,
1/
19/
00,
D.
Hrdy.

15.
Because
of
the
recommended
changes
in
tolerance
expression,
a
new
enforcement
method
capable
of
determining
imazalil
and
any
metabolite
containing
the
2,4­
dichlorophenyl
group
in
livestock
commodities
is
required.
The
registrant
must
continue
to
develop/
validate
enforcement
method(
s)
for
a
set
of
marker
compounds
that
account
for
a
high
percentage
of
the
total
toxic
residues
in
ruminant.
HED
will
correct
residues
to
account
for
the
total
toxic
residue
for
the
purpose
of
tolerance
reassessment
as
well
as
for
assessing
dietary
risk
exposure.

16.
DP
Barcode
D238452,
1/
20/
99,
S.
Piper.

17.
DP
Barcode
D242498
(
currently
under
secondary
review
at
HED).

18.
The
following
metabolites
must
be
tested
through
FDA's
multiresidue
protocols:
(
I)
metabolite
R014821;
(
ii)
marker
metabolites
in
milk
and
ruminant
tissues
(
FK772
and
FK284).
The
registrant
is
required
to
follow
the
directions
for
the
protocols
found
in
PAM
Volume
I,
Appendix
II
starting
with
the
decision
tree
for
multiresidue
methods
testing
and
the
accompanying
guidance
found
in
the
suggestions
for
producing
quality
data;
i.
e.
decisions
on
what
protocols
to
follow
and
proper
application
of
methods.
If
the
decision
tree
indicates
that
recovery
is
likely,
the
registrant
should
consult
the
data
development
section
of
the
proper
protocols
and
follow
the
guidance
offered
precisely
to
generate
quality
data.

19.
DP
Barcode
D187775,
3/
2/
93,
S.
Funk.

20.
DP
Barcode
D191318,
11/
18/
93,
D.
Miller.

21.
DP
Barcode
D220386,
5/
8/
96,
S.
Funk.
Table
B
(
continued).

Page
31
of
50
22.
DP
Barcode
D194151,
12/
21/
93,
S.
Funk.
23.
Adequate
residue
data
have
been
submitted
for
wheat
grain.
Residue
data
for
wheat
aspirated
grain
fractions
are
not
required
because
imazalil's
registered
use
on
wheat
is
limited
to
seed
treatment.

24.
DP
Barcode
D205092,
1/
20/
95,
L.
Cheng.

25.
Adequate
residue
data
have
been
submitted
for
barley
straw.
Table
1
of
OPPTS
GLN
860.1000
now
lists
hay
as
a
RAC
of
barley,
but
forage
was
removed
from
the
list.
No
data
for
barley
hay
have
been
submitted.
The
available
data
for
barley
forage
and
straw
will
be
translated
to
barley
hay.

26.
Adequate
residue
data
have
been
submitted
for
wheat
forage
and
straw.
Table
1
of
OPPTS
GLN
860.1000
now
lists
hay
as
a
RAC
of
wheat,
and
no
data
for
wheat
hay
have
been
submitted.
The
available
data
for
wheat
forage
and
straw
will
be
translated
to
wheat
hay.

27.
DP
Barcode
D170886,
8/
13/
92,
A.
Aikens.

28.
DP
Barcode
D189963,
7/
14/
94,
L.
Cheng.

29.
There
are
no
registered
uses
of
imazalil
on
cottonseed
for
which
a
tolerance
is
established.
To
date,
no
registrants
have
committed
to
support
imazalil
use
on
cottonseed.
Unless
Janssen
Pharmaceutica
or
other
registrants
submit
supporting
residue
data,
HED
will
recommend
for
tolerance
revocation.

30.
The
requirements
for
barley
and
wheat
processing
studies
are
waived
based
on
the
theoretical
concentration
factors
for
barley
and
wheat
grain
processed
commodities
(
1.2­
9x),
on
apparent
residues
<
LOQ
from
the
use
of
exaggerated
application
rates
(
6.3x
and
10x),
and
on
the
use
pattern
(
seed
treatment),
which
is
unlikely
to
result
in
surface
residues
on
the
grain.
The
combined
residues
of
imazalil
and
its
metabolite
R014821
in/
on
barley
and
wheat
processed
commodities
are
not
likely
to
exceed
the
reassessed
tolerance
of
barley
and
wheat
grains.

31.
DP
Barcode
D181319,
9/
3/
92,
S.
Funk.

32.
DP
Barcode
D182575,
2/
17/
93,
S.
Funk.

33.
DP
Barcode
D244510,
1/
22/
99,
S.
Piper.

34.
A
determination
of
tolerances
resulting
from
a
fumigation
application
has
not
yet
been
made.
Residue
data
for
this
use
remains
a
data
gap
(
see
773­
EUP­
R,
memo
of
8/
12/
85,
A.
Reiter
and
S.
Hummel).
Page
32
of
50
TOLERANCE
REASSESSMENT
SUMMARY
Tolerances
for
residues
in/
on
plant
commodities
are
established
under
40
CFR
§
180.413(
a).
They
are
currently
expressed
in
terms
of
the
combined
residues
of
imazalil
[
1­(
2­(
2,4­
dichlorophenyl)­
2­(
2­
propenyloxy)
ethyl)­
1H­
imidazole]
and
its
metabolite
R014821
[
1­(
2,4­
dichlorophenyl)­
2­
(
1H­
imidazole­
1­
yl)­
1­
ethanol].
The
qualitative
nature
of
the
residue
in
plants
is
adequately
understood.
HED
has
determined
that
the
current
tolerance
expression
for
plant
commodities
is
appropriate.

Tolerances
for
residues
in
livestock
commodities
are
established
under
40
CFR
§
180.413(
b).
They
are
currently
expressed
in
terms
of
the
combined
residues
of
imazalil
and
its
metabolites
R014821
and
R042243
[
3­[
1­(
2,4­
dichlorophenyl)­
2­(
1H­
imidazole­
1­
yl)
ethoxyl]­
1,2­
propanediol].
The
qualitative
nature
of
the
residue
in
livestock
is
adequately
understood.
The
HED
Metabolism
Committee
concluded
that,
in
the
absence
of
information
to
the
contrary,
any
metabolite
containing
the
2,4­
dichlorophenyl
moiety
is
of
toxicological
concern
and
must
be
included
in
the
conduct
of
the
dietary
risk
assessment
but
a
list
of
marker
metabolites
in
addition
to
imazalil
should
be
defined
for
inclusion
in
the
tolerance
expression
(
L.
Cheng,
8/
30/
94).

The
tolerance
expression
for
livestock
commodities
listed
under
40
CFR
§
180.413(
b)
should
be
amended
to
regulate
imazalil,
3­[
2­(
2,4­
dichlorophenyl)­
2­(
2,3­
dihydroxypropoxy)
ethyl]­
2,4­
imidazolidinedione
(
FK772),
and
3­[
2­(
2,4­
dichlorophenyl)­
2­(
hydroxy)]­
2,4­
imidazolidinedione
(
FK284).
Because
of
issues
related
to
residue
analytical
methods,
HED
hereby
defines
a
list
of
marker
metabolites
representing
the
2,4­
dichlorophenyl
group
moiety.
For
dietary
assessment,
the
total
toxic
residues
will
be
adjusted
using
the
ratios
of
imazalil
and
the
marker
metabolites
that
were
found
in
the
livestock
metabolism
studies.
The
marker
compounds
in
milk
and
ruminant
tissues
are
imazalil,
FK772,
and
FK284;
these
marker
compounds
collectively
represent
the
following
percentages
of
the
total
toxic
residues,
as
determined
by
the
ruminant
metabolism
studies:
21%
in
milk,
72%
in
muscle,
71%
in
kidney,
44%
in
liver,
and
33%
in
fat.
The
chemical
names
and
structures
of
these
marker
metabolites
are
depicted
in
Figure
B.

A
summary
of
imazalil
tolerance
reassessments
is
presented
in
Table
C.
The
reassessments
of
tolerances
for
some
commodities
are
contingent
upon
the
implementation
of
the
requested
label
revision.
Page
33
of
50
Tolerances
Established
Under
40
CFR
§
180.413(
a)

Sufficient
field
trial
data
reflecting
the
maximum
label
use
pattern
are
available
to
reassess
the
established
tolerances
for
the
following
RACs
as
defined:
bananas
(
whole);
bananas
(
pulp);
barley,
forage;
barley,
grain;
barley
straw;
citrus
fruits
(
POST­
H);
wheat,
forage;
wheat,
grain;
and
wheat,
straw.

The
established
tolerances
listed
under
40
CFR
§
180.413(
a)
are
reassessed
at
the
same
levels
except
those
listed
for
the
grains
of
barley
and
wheat.
Higher
tolerances
are
required
for
barley
and
wheat
grains,
from
0.05
ppm
to
0.1
ppm,
to
reflect
the
sensitivity
of
the
data­
collection
method
and
to
account
for
apparent
residues
in/
on
control
grain
samples.

Acceptable
citrus
processing
studies,
reflecting
postharvest
treatments,
have
been
submitted
and
evaluated.
The
data
from
these
studies
showed
that
residues
of
imazalil
and
its
metabolite
R014821
do
not
concentrate
in
juice
but
do
concentrate
in
oil.
In
oil,
the
average
concentration
of
total
residues
was
3.3x
in
lemon,
15.0x
in
grapefruit,
and
28.0x
in
oranges;
the
overall
average
concentration
factor
in
oil
for
the
three
citrus
crops
was
16.0x.
These
processing
data
suggest
that
a
tolerance
for
juice
is
not
needed,
and
that
the
established
tolerance
of
25
ppm
for
citrus
oil
is
too
low.
The
maximum
combined
residues
of
imazalil
and
its
metabolite
R014821
expected
in
citrus
oil,
based
on
the
HAFT
residue
for
oranges
(
6.68
ppm)
and
the
maximum
average
concentration
factor
for
oranges
(
28.0x)
would
be
187
ppm.
The
reassessed
tolerance
for
citrus
oil
is,
therefore,
200
ppm.

The
available
citrus
processing
studies
reflecting
postharvest
treatments
showed
that
residues
of
imazalil
and
its
metabolite
R014821
concentrated
marginally
in
dried
pulp.
The
maximum
average
concentration
factor
of
total
residues
in
orange
dried
pulp
was
2.5x;
the
overall
average
concentration
factor
of
total
residues
in
citrus
dried
pulp
was
1.7x.
These
processing
data
suggest
that
the
established
tolerance
of
25
ppm
for
dried
pulp
is
adequate.
The
maximum
combined
residues
of
imazalil
and
its
metabolite
R014821
expected
in
citrus
dried
pulp,
based
on
the
HAFT
residue
for
oranges
(
6.68
ppm)
and
the
maximum
average
concentration
factor
for
oranges
(
2.5x)
would
be
16.7
ppm.

The
reregistration
requirements
for
barley
and
wheat
grain
processing
studies
have
been
waived.
Therefore,
tolerances
for
the
processed
commodities
of
barley
and
wheat
are
not
required.

The
established
tolerance
for
banana
pulp
should
be
revoked
since
it
is
the
Agency
policy
to
establish
a
tolerance
on
the
whole
commodity
(
including
peel
after
removing
and
discarding
crown
tissue
and
stalk).
The
available
data
on
banana
pulp
may
be
used
for
the
purpose
of
dietary
risk
assessment.

The
established
tolerance
for
cottonseed
should
be
revoked
because
there
are
no
registered
uses
of
imazalil
on
cottonseed,
and
no
registrants
have
committed
to
support
imazalil
use
on
cotton.
Page
34
of
50
Tolerances
To
Be
Proposed
Under
40
CFR
§
180.413(
a)

Tolerances
for
barley
hay
and
wheat
hay
must
be
proposed.
The
available
data
for
barley
forage
and
straw
will
be
translated
to
barley
hay.
The
available
data
for
wheat
forage
and
straw
will
be
translated
to
wheat
hay.
A
tolerance
of
0.5
ppm
is
recommended
for
both
barley
and
wheat
hay.

Tolerances
Established
Under
40
CFR
§
180.413(
b)

An
acceptable
ruminant
feeding
study
has
been
submitted
and
evaluated.
At
the
feeding
level
of
33
ppm,
the
maximum
combined
residues
of
imazalil
and
the
marker
metabolites
(
FK772
and
FK284)
were
0.054
ppm
in
milk,
0.050
ppm
in
muscle,
0.956
ppm
in
liver,
0.155
ppm
in
kidney,
and
0.026
ppm
in
fat.

The
reassessed
tolerances
are
0.02
ppm
for
milk,
0.02
ppm
for
muscle
of
cattle,
goats,
horses,
and
sheep;
0.01
ppm
for
fat
of
cattle,
goats,
horses,
and
sheep;
0.20
ppm
for
mbyp
(
meat
by­
products)
of
cattle,
goats,
horses,
and
sheep;
and
0.20
ppm
for
liver
of
cattle,
goats,
horses,
and
sheep.

A
poultry
feeding
study
was
required
to
determine
whether
tolerances
would
be
required
for
imazalil
residues
of
concern
in
eggs
and
poultry
tissues.
There
is
no
reasonable
expectation
of
finite
residues
[
40
CFR
§
180.6(
a)(
3)].
However,
a
determination
of
tolerances
resulting
from
a
fumigation
application
has
not
yet
been
made
and
remains
a
data
gap
(
see
773­
EUP­
R,
memo
of
8/
12/
85,
A.
Reiter
and
S.
Hummel.)

Pending
Tolerance
Petitions
PP#
4F3096:
Janssen
Pharmaceutica
had
originally
proposed
in
a
petition,
FAP
4H5434,
the
establishment
of
tolerances
for
residues
of
imazalil
and
its
metabolite
R014821
[
1­(
2,4­
dichlorophenyl)­
2­(
1H­
imidazole­
1­
yl)­
1­
ethanol]
in/
on
the
pome
fruit
group
at
7.0
ppm
and
in
wet/
dry
apple
pomace
at
30
ppm.
The
petitioner
subsequently
withdrew
FAP
4H5434
and
revised
PP#
4F3096,
for
the
establishment
of
a
tolerance
on
pear
at
10
ppm.
Following
review
of
the
proposed
uses
and
residue
data,
HED
recommended
for
the
establishment
of
a
tolerance
on
pear
at
10
ppm
(
DP
Barcode
D197176,
6/
2/
94,
M.
I.
Rodriguez).
Janssen
Pharmaceutica
proposed
in
a
separate
petition,
PP#
7F3530,
for
tolerances
on
melons
(
excluding
watermelon)
by
post­
harvest
application
and
sweet
corn
by
seed
treatment.
Page
35
of
50
Table
C.
Tolerance
Reassessment
Summary
for
Imazalil.

Commodity
Current
Tolerance,
ppm
Reassessed
Tolerance,
ppm
Comment
[
Correct
Commodity
Definition]

Tolerances
Established
Under
40
CFR
§
180.413(
a)

Bananas
(
Whole)
3.00
3.0
The
tolerance
for
banana
pulp
should
be
revoked
because
it
is
the
Agency
policy
to
establish
a
tolerance
on
the
whole
commodity
(
including
peel
after
removing
and
discarding
crown
tissue
and
stalk).
The
available
data
on
banana
pulp
may
be
used
for
the
purpose
of
dietary
risk
assessment.
Bananas
(
Pulp)
0.20
Revoke
Barley,
forage
0.5
Revoke
This
RAC
has
been
deleted
from
Table
1
of
OPPTS
GLN
860.1000.

Barley,
grain
0.05
0.1
A
higher
tolerance
is
needed
to
reflect
the
sensitivity
of
the
data­
collection
method
and
to
account
for
apparent
residues
in/
on
control
grain
samples.

Barley,
straw
0.5
0.5
Citrus
fruit
(
POST­
H)
10.0
10.0
Citrus
oil
25.0
200
Citrus
pulp
(
dried)
25.0
25
Cottonseed
0.05
Revoke
The
tolerance
should
be
revoked
because
there
are
no
registered
uses
of
imazalil
on
cottonseed,
and
no
registrants
have
committed
to
support
imazalil
use
on
cottonseed.

Wheat,
forage
0.5
0.5
Wheat,
grain
0.05
0.1
A
higher
tolerance
is
needed
to
reflect
the
sensitivity
of
the
data­
collection
method
and
to
account
for
apparent
residues
in/
on
control
grain
samples.

Wheat,
straw
0.5
0.5
Tolerances
To
Be
Proposed
Under
40
CFR
§
180.413(
a)

Barley,
hay
None
established
0.5
The
available
data
for
barley
forage
and
straw
will
be
translated
to
barley
hay.

Wheat,
hay
None
established
0.5
The
available
data
for
wheat
forage
and
straw
will
be
translated
to
wheat
hay.

Tolerances
Established
Under
40
CFR
§
180.413(
b)

Cattle,
fat
0.01
0.01
Cattle,
liver
0.50
0.20
Cattle,
meat
0.01
0.02
Cattle,
mbyp
0.01
0.20
Cattle,
meat
byproducts
Goats,
fat
0.01
0.01
Goat,
fat
Goats,
liver
0.50
0.20
Goat,
liver
Goats,
meat
0.01
0.02
Goat,
meat
Goats,
mbyp
0.01
0.20
Goat,
meat
byproducts
Hogs,
fat
0.01
Revoke
§
180.6(
a)
3
Hogs,
liver
0.50
Revoke
§
180.6(
a)
3
Hogs,
meat
0.01
Revoke
§
180.6(
a)
3
Hogs,
mbyp
0.01
Revoke
§
180.6(
a)
3
Horses,
fat
0.01
0.01
Horse,
fat
Horses,
liver
0.50
0.20
Horse,
liver
Horses,
meat
0.01
0.02
Horse,
meat
Commodity
Current
Tolerance,
ppm
Reassessed
Tolerance,
ppm
Comment
[
Correct
Commodity
Definition]

Page
36
of
50
Horses,
mbyp
0.01
0.20
Horse,
meat
byproducts
Milk
0.01
0.02
Sheep,
fat
0.01
0.01
Sheep,
liver
0.50
0.20
Sheep,
meat
0.01
0.02
Sheep,
mbyp
0.01
0.20
Sheep,
meat
byproducts
However,
a
determination
of
tolerances
resulting
from
a
fumigation
application
has
not
yet
been
made
and
remains
a
data
gap
(
see
773­
EUP­
R,
memo
of
8/
12/
85,
A.
Reiter
and
S.
Hummel).
Page
37
of
50
CODEX
HARMONIZATION
The
Codex
Alimentarius
Commission
has
established
several
maximum
residue
limits
(
MRLs)
for
imazalil
in/
on
various
raw
agricultural
commodities.
The
Codex
MRLs
are
expressed
in
terms
of
imazalil
per
se.
The
Codex
MRLs
and
the
U.
S.
tolerances
are
incompatible
with
respect
to
tolerance
expression.
The
U.
S.
tolerances
for
plant
commodities
are
in
expressed
terms
of
the
combined
residues
of
imazalil
and
its
metabolite
R014821.
The
expression
of
U.
S.
tolerances
for
livestock
commodities
will
be
amended
to
include
imazalil,
marker
metabolite
FK772,
and
marker
metabolite
FK284.
Both
Codex
and
U.
S.
have
established
MRLs/
tolerances
for
bananas,
citrus
fruits,
and
wheat
grain,
forage,
hay,
and
straw.
However,
the
residue
levels
are
not
in
harmony
presumably
because
of
differences
in
good
agricultural
practices.
A
numerical
comparison
of
the
Codex
MRLs
and
the
corresponding
reassessed
U.
S.
tolerances
is
presented
in
Table
D.

Table
D.
Codex
MRLs
for
Imazalil
and
applicable
U.
S.
tolerances.

Codex
Reassessed
U.
S.
Tolerance
(
ppm)
Recommendation
and
Comments
Commodity
(
As
Defined)
MRL
(
mg/
kg)
Step
Banana
2
Po
a
CXL
3.0
Citrus
fruits
5
Po
CXL
10.0
Cucumber
0.5
CXL
No
U.
S.
registration.

Gherkin
0.5
CXL
No
U.
S.
registration.

Melons,
except
watermelon
2
CXL
No
U.
S.
registration.

Persimmon,
Japanese
2
Po
CXL
No
U.
S.
registration.

Pome
fruits
5
Po
CXL
No
U.
S.
registration.

Potato
5
Po
b
CXL
No
U.
S.
registration.

Raspberries,
Red,
Black
2
CXL
No
U.
S.
registration.

Strawberry
2
CXL
No
U.
S.
registration.

Wheat
0.01(*)
c
CXL
0.1
for
grain
Wheat
straw
and
fodder,
Dry
0.1
CXL
0.5
for
forage,
hay,
and
straw
a
Po
=
Postharvest
treatment
of
the
commodity.
b
Washed
before
analysis.
c
Asterisk
designates
MRL
set
at
the
limit
of
quantitation.
Page
38
of
50
AGENCY
MEMORANDA
RELEVANT
TO
REREGISTRATION
DP
Barcode:
None
Subject:
Imazalil.
DEB
Phase
4
Review.
From:
S.
Funk
To:
K.
Davis
Dated:
10/
18/
90
MRID:
None
DP
Barcode:
D164394
Subject:
Protocol
for
Determination
of
the
Nature
of
the
Residue
in
Ruminants
for
Imazalil.
From:
S.
Funk
To:
K.
Davis
Dated:
7/
2/
91
MRID:
None
DP
Barcode:
D165032
Subject:
Protocols
for
the
Citrus
Processing
and
Winter
Wheat
Field
Trials
for
Imazalil.
From:
S.
Funk
To:
K.
Davis
Date:
7/
16/
91
MRID(
s):
None
DP
Barcode:
D168504
Subject:
Reregistration
of
Imazalil.
Janssen
Pharmaceutica
90
Day
Response
to
Phase
4
DCI.
From:
S.
Funk
To:
K.
Davis
Dated:
12/
3/
91
MRID:
None
DP
Barcode:
D168495
Subject:
Response
to
Registrant's
Concerns/
Questions
Arising
from
the
Imazalil
Phase
4
Reregistration
DCI.
From:
B.
Cropp­
Kohlligian
To:
B.
Briscoe
Dated:
1/
28/
92
MRID:
None
DP
Barcode:
D171401
Subject:
ID#
111901­
43813.
Imazalil.
Response
to
Phase
IV
Review.
From:
L.
Cheng
To:
K.
Davis
Dated:
2/
4/
92
MRID:
42012005
through
42012009
DP
Barcode:
D173008
Subject:
Reregistration
of
Imazalil.
Protocol
for
Nature
of
the
Residue
in
Wheat.
From:
S.
Funk
To:
K.
Davis
Date:
2/
25/
92
MRID(
S):
None
Page
39
of
50
DP
Barcode:
D179225
Subject:
Reregistration
of
Imazalil.
Poultry
Metabolism
Protocol.
From:
S.
Funk
To:
K.
Davis
Dated:
8/
6/
92
MRID:
None
DP
Barcode
D170886
Subject:
Imazalil
Reregistration.
Magnitude
of
the
Residue
­
Post
Harvest
Treatment
of
Bananas
(
Foreign).
Guideline
171­
4k
(
Magnitude
of
the
Residue
­
Crop
Field
Trial).
From:
A.
Aikens
To:
B.
Briscoe
and
K.
Davis
Date:
8/
13/
92
MRID:
42058701
DP
Barcode:
D181319
Subject:
Imazalil:
FIFRA
6(
a)(
2)
Data
and
Reregistration.
Processing
Studies
for
Citrus:
Preliminary
Findings.
From:
S.
Funk
To:
K.
Davis
Dated:
9/
3/
92
MRID:
42348301
and
42405501
DP
Barcode:
D179225
Subject:
Reregistration
of
Imazalil.
Poultry
Metabolism
Protocol.
Addendum
to
Memorandum
of
8/
6/
92.
From:
S.
Funk
To:
K.
Davis
Dated:
9/
24/
92
MRID:
None
DP
Barcode:
D181284
Subject:
Imazalil.
Product
Chemistry
Data
and
Stability
of
3H­
Imazalil.
From:
L.
Cheng
To:
K.
Davis
Dated:
9/
25/
92
MRID:
42403101
and
42403102
DP
Barcode:
None
Subject:
Non­
concurrence
on
Draft
FR
Notice.
PP#
5F3250.
Imazalil
on
Forage
and
Hay
of
Wheat
and
Barley.
From:
R.
Cook
To:
C.
Giles­
Parker
Date:
1/
7/
93
MRID(
s):
None
DP
Barcodes:
D182706
and
D186541
Subject:
Imazalil,
Reregistration.
Nature
of
the
Residue
in
Ruminant
and
Analytical
Methods
for
Plants.
From:
J.
Abbotts
To:
K.
Depukat
Dated:
2/
17/
93
MRID:
42454801
through
42454804,
and
42593602
Page
40
of
50
DP
Barcode:
D182575
Subject:
Imazalil.
Citrus
processing
Studies.
From:
S.
Funk
To:
K.
Davis
Dated:
2/
17/
93
MRID:
42454806
DP
Barcode:
D187775
Subject:
Imazalil:
Citrus
and
Citrus
Processed
Commodities
Storage
Stability.
From:
S.
Funk
To:
K.
Depukat
Date:
3/
2/
93
MRID(
s):
42643301
DP
Barcode:
D189000
Subject:
Imazalil:
(
1)
Wheat
Processing
Waiver
Request;
(
2)
Poultry
Metabolism
Protocol
Change.
From:
S.
Funk
To:
K.
Davis
and
K.
Depukat
Date:
4/
6/
93
MRID(
s):
None
DP
Barcode:
None
Subject:
Meeting
with
Janssen
Pharmaceutica,
4/
28/
93,
on
Imazalil
Metabolism
in
Goat.
From:
J.
Abbotts
To:
K.
Depukat
Dated:
4/
30/
93
MRID:
None
DP
Barcode:
D182707
Subject:
Imazalil
(
List
B;
Case
2325;
Chemical
111901):
Analytical
Method
for
the
Determination
of
Imazalil
and
R14821
in/
on
Bananas,
Citrus,
and
Citrus
Processed
Commodities.
Research
Method
and
Enforcement
Method
Comparison.
From:
S.
Funk
To:
K.
Depukat
and
K.
Davis
Dated:
6/
24/
93
MRID(
s):
42454803
through
42454805
DP
Barcode:
D193375
Subject:
Imazalil,
Reregistration.
Nature
of
the
Residue
in
Ruminant,
Supplemental
Data.
From:
J.
Abbotts
To:
K.
Depukat
Dated:
8/
17/
93
MRID:
42838201
DP
Barcode:
D194053
Subject:
FAP#
3H5680.
Reregistration
of
Imazalil.
Petition
for
a
Revised
Tolerance
for
Banana
Pulp
(
PP#
8E2100).
Petition
for
a
Revised
Food
Additive
Tolerance
for
Citrus
Oil.
From:
S.
Funk
To:
C.
Giles­
Parker,
J.
Stone,
K.
Davis,
and
K.
Depukat
Dated:
11/
3/
93
MRID:
None
Page
41
of
50
DP
Barcode:
D195726
Subject:
Imazalil
(
List
B,
Chemical
111901,
Case
2325).
Nature
of
the
Residue
in
Poultry
(
Preliminary).
From:
S.
Funk
To:
K.
Davis
and
K.
Depukat
Date:
11/
17/
93
MRID:
42949401
DP
Barcode:
D191318
Subject:
Imazalil.
Storage
stability
in
Wheat
(
Grain,
Forage,
and
Straw).
From:
D.
Miller
To:
K.
Depukat
Date:
11/
18/
93
MRID:
42755301
DP
Barcode:
D194151
Subject:
Reregistration
of
Imazalil
(
List
B,
Chemical
111901,
Case
2325).
Magnitude
of
the
Residue
in
Wheat
and
Barley
(
171­
4(
k))
and
in
Processed
Commodities
of
Wheat
and
Barley
(
171­
4(
l)).
From:
S.
Funk
To:
K.
Davis
and
K.
Depukat
Dated:
12/
21/
93
MRID:
42852001,
42852002,
and
42868101
DP
Barcode:
D187506
Subject:
Imazalil.
Case
No.
2325.
Registrant's
Response
to
Reregistration.
From:
L.
Cheng
To:
K.
Depukat
Dated:
1/
10/
94
MRID:
42626901
through
42626903
DP
Barcode:
D198235
Subject:
Imazalil.
Case
2325.
Phase
IV
Review
of
Orange
and
Banana
Metabolism
Studies.
From:
L.
Cheng
To:
K.
Depukat
Dated:
5/
3/
94
MRIDs:
42012008
and
42012009
DP
Barcode:
D197176
Subject:
PP4F3096:
Imazalil
(
Fungaflor
500
EC)
in/
on
Pears.
Amendment
Dated
11/
22/
93.
From:
M.
I.
Rodriguez
To:
C.
Giles­
Parker,
J.
Stone,
and
A.
Kocialski
Dated:
6/
2/
94
MRID:
None
DP
Barcode:
D189963
Subject:
Imazalil.
Case
2325.
Registrant's
Response
to
Magnitude
of
the
Residue
in/
on
Bananas.
From:
L.
Cheng
To:
K.
Depukat
Dated:
7/
14/
94
MRID:
42710501
Page
42
of
50
DP
Barcode:
D198599
Subject:
Imazalil.
Case
No.
2325.
Nature
of
the
Residue
in
Laying
Hen.
From:
L.
Cheng
To:
K.
Depukat
Dated:
7/
14/
94
MRID:
43076101
DP
Barcode:
None
Subject:
Imazalil.
Hen
and
Ruminant
Metabolism
Studies.
To
be
Presented
to
the
HED
Metabolism
Committee
on
August
8,
1994.
From:
L.
Cheng
To:
HED
Metabolism
Committee
Dated:
8/
4/
94
MRID:
None
DP
Barcode:
None
Subject:
Imazalil.
Laying
Hen
and
Lactating
Goat
Metabolism.
The
Metabolism
Committee
Meeting
Held
on
August
18,
1994.
From:
L.
Cheng
To:
The
HED
Metabolism
Committee
Dated:
8/
30/
94
MRID(
s):
None
DP
Barcode:
D205954
Subject:
Imazalil.
Case
No.
2325.
Supplemental
Data
to
Orange
Metabolism
Study.
From:
L.
Cheng
To:
K.
Depukat
Dated:
9/
22/
94
MRID:
43308401
DP
Barcode:
None
Subject:
Imazalil.
Case
No.
2325.
Residues
to
be
Measured
in
the
Animal
Feeding
Studies.
From:
L.
Cheng
To:
K.
Depukat
Dated:
11/
1/
94
MRID(
s):
None
DP
Barcode:
D206723
Subject:
Imazalil.
Case
No.
2325.
Rebuttal
to
Geographic
Representation
for
Postharvest
Use:
Bananas.
From:
L.
Cheng
To:
K.
Depukat
Dated:
11/
29/
94
MRID:
None
DP
Barcode:
D209996
Subject:
Imazalil.
Case
No.
2325.
Metabolism
on
Banana
­
Postharvest
Treatment.
Review
of
Protocol.
From:
L.
Cheng
To:
K.
Depukat
Dated:
1/
3/
95
MRID:
None
Page
43
of
50
DP
Barcode:
D205092
Subject:
Imazalil.
Case
No.
2325.
Magnitude
of
Residue
in
Winter
Wheat
Forage,
Straw
and
Grain
Grown
From
Treated
Seed.
From:
L.
Cheng
To:
K.
Depukat
Dated:
1/
20/
95
MRID:
43285001
DP
Barcode:
D215063
Subject:
Imazalil
­
Application
of
DES
Proviso
to
Existing
Feed
Additive
Tolerances
From:
G.
Kramer
To:
Chemistry
Branch
Files
Dated:
5/
12/
95
MRID:
None
DP
Barcode:
D214575
Subject:
Imazalil.
Case
No.
2325.
Residue
Analytical
Method
for
the
Animal
Feeding
Studies.
From:
L.
Cheng
To:
K.
Depukat
Dated:
6/
8/
95
MRID(
s):
None
DP
Barcode:
D220386
Subject:
Imazalil
(
Chemical
111901,
Case
2325,
List
B):
Citrus
Oil
Food
Additive
Tolerance.
From:
S.
Funk
To:
N.
Nazmi
and
W.
Hazel
Dated:
5/
8/
96
MRIDs:
92072030
and
92072040
DP
Barcode:
D224876
Subject:
Imazalil.
Case
2325.
Metabolism
on
Bananas
From
Post­
Harvest
Treatment.
From:
L.
Cheng
To:
P.
Deschamp
Dated:
6/
12/
96
MRID(
s):
43965701
DP
Barcode:
D239118
Subject:
Imazalil
(
Chemical
111901,
Case
2325,
List
B).
GLN
860.1480.
Protocol
for
a
Ruminant
Feeding
Study.
From:
S.
Funk
To:
D.
Monos
and
W.
Waldrop
Dated:
10/
30/
97
MRID:
None
DP
Barcode:
D247703
Subject:
Imazalil
(
111901),
Registrant
response
to
Poultry
Feeding
Study.
From:
S.
Piper
To:
K.
Farwell
Dated:
9/
18/
98
MRID:
None
Page
44
of
50
DP
Barcode:
D238452
Subject:
Imazalil
(
Chemical
111901,
Case
2325,
List
B).
Analytical
Method
­
Ruminants
From:
S.
Piper
To:
M.
Metzger
Dated:
1/
20/
99
MRID:
44337701
DP
Barcode:
D245510
Subject:
Imazalil
(
Chemical
111901,
Case
2325,
List
B).
Janssen
Pharmaceutica.
GLN
860.1480.
Ruminant
Feeding
Study.
From:
S.
Piper
To:
M.
Metzger
Dated:
1/
22/
99
MRID:
44568301
DP
Barcode:
D242498
Subject:
Method
Validation
for
a
Proposed
Enforcement
Method
­
Animal
Commodities.
From:
David
E.
Hrdy,
Biologist
To:
Susan
V.
Hummel,
Branch
Senior
Scientist
Dated:
1/
19/
00
MRID:
44455601
DP
Barcode:
D244510
Subject:
Radiovalidation
of
PAM
Vol.
II
Method
Using
Samples
From
Banana
Metabolism
Study.
From:
David
E.
Hrdy,
Biologist
To:
Susan
V.
Hummel,
Branch
Senior
Scientist
Dated:
1/
19/
00
MRID:
44532901
MASTER
RECORD
IDENTIFICATION
NUMBERS
References
Used
To
Support
Reregistration
00027532
Meuldermans,
W.;
Swijsen,
E.;
Hendricks,
E.;
et
al.
(
1979)
The
Metabolic
Fate
of
Imazalil
on
Oranges.
(
Unpublished
study
received
Mar
5,
1980
under
AZ
79/
5;
prepared
by
Janssen
Pharmaceutica,
submitted
by
state
of
Arizona
for
Janssen
R
&
D,
Inc.,
New
Brunswick,
N.
J.;
CDL:
241950­
B)

00027533
Meuldermans,
W.;
Swijsen,
E.;
Hendricks,
E.;
et
al.
(
1979)
Plasma
and
Milk
Levels,
Distribution,
Excretion
and
Biotransformation
of
Imazalil
after
Repeated
Administration
to
a
Lactating
Goat.
(
Unpublished
study
received
Mar
5,
1980
under
AZ
79/
5;
prepared
by
Janssen
Pharmaceutica,
submitted
by
state
of
Arizona
for
Janssen
R
&
D,
Inc.,
New
Brunswick,
N.
J.;
CDL:
241950­
C)

00079192
Meuldermans,
W.;
Woestenborghs,
R.;
Michielsen,
L.;
et
al.
(
1981)
Residue
Levels
of
Imazalil
and
Two
of
Its
Basic
Metabolites
in
Cows
following
Repeated
Oral
Dosing
at
Three
Dose
Levels:
R
23
979/
24.
(
Unpublished
study
received
Jun
25,
1981
under
43818­
1;
prepared
by
Janssen
Pharmaceutica
N.
V.,
Belgium,
submitted
by
Edmar
Cleaning
Corp.,
Long
Island
City,
N.
Y.;
CDL:
245310­
E)

00079193
Meuldermans,
W.;
Woestenborghs,
R.;
Michielsen,
L.;
et
al.
(
1981)
Milk
Levels
of
Imazalil
and
Two
of
Its
Basic
Metabolites
in
Lactating
Cows
following
Repeated
Oral
Dosing
of
Three
Dose
Levels:
R
23
979/
23.
(
Unpublished
Page
45
of
50
study
received
Jun
25,
1981
under
43818­
1;
prepared
by
Janssen
Pharmaceutical
N.
V.,
Belgium,
submitted
by
Edmar
Cleaning
Corp.,
Long
Island
City,
N.
Y.;
CDL:
245310­
F)

00084644
Meuldermans,
W.;
Swysen,
E.;
Hendrickx,
J.;
et
al.
(
1981)
Plasma
and
Milk
Levels,
Distribution,
Excretion
and
Biotransformation
of
Imazalil
after
Repeated
Administration
to
a
Lactating
Goat:
Addendum
1:
Levels
of
Tritiated
Water
in
the
Various
Tissues,
and
Further
Data
on
the
Metabolite
Pattern
in
Liver:
Serial
No.
R
23
979/
14
Add.
1.
(
Unpublished
study
received
Oct
8,
1981
under
43813­
1;
prepared
by
Janssen
Pharmaceutica,
Belgium,
sub­
00087541
Janssen
R
&
D,
Incorporated
(
1981)
[
Residue
of
Imazalil
on
Bananas].
(
Unpublished
study
received
Dec
3,
1981
under
8E2100;
CDL:
070508­
A)

00087542
Meuldermans,
W.;
Hurkmans,
R.;
Hendrickx,
J.;
et
al.
(
1980)
The
Metabolic
Fate
of
Imazalil
on
Banana
Plants:
Serial
No.
R
23
979/
21.
(
Unpublished
study
received
Dec
3,
1981
under
8E2100;
prepared
by
Janssen
Pharmaceutica,
Belgium,
submitted
by
Janssen
R
&
D,
Inc.,
New
Brunswick,
N.
J.;
CDL:
070508­
B)

00087543
Meuldermans,
W.;
Hurkmans,
R.;
Buedts,
J.;
et
al.
(
1981)
The
Metabolic
Fate
of
Imazalil
on
Banana
Plants.
Addendum
1:
Translocation
into
Sleeved
Bunches:
Serial
No.
R
23
979/
25.
(
Unpublished
study
received
Dec
3,
1981
under
8E2100;
prepared
by
Janssen
Pharmaceutica,
Belgium,
submitted
by
Janssen
R
&
D,
Inc.,
New
Brunswick,
N.
J.;
CDL:
070508­
C)

00096418
Vonk,
J.
W.
(
1977)
The
Fate
of
Imazalil
in
Barley
Plants
Grown
from
Treated
Seed:
Report
of
Project
2.
(
Unpublished
study
received
Feb
24,
1982
under
43813­
1;
prepared
by
Organisch
Chemisch
Instituut
TNO,
The
Netherlands,
submitted
by
Janssen
R
&
D,
Inc.,
New
Brunswick,
N.
J.;
CDL:
070702­
C)

00109269
Goodwine,
W.
(
1982)
Letter
sent
to
H.
Jacoby
dated
Jul
27,
1982:
Imazalil­­
Citrus.
(
Unpublished
study
received
Jul
27,
1982
under
43813­
1;
submitted
by
Janssen
R
&
D,
Inc.,
New
Brunswick,
NJ;
CDL:
071009­
A)

00127900
Janssen
R
&
D,
Inc.
(
1983)
[
Residues
of
Imazalil].
(
Compilation;
unpublished
study
received
Apr
28,
1983
under
43813­
3;
CDL:
071574­
B)

00150020
Woestenborghs,
R.
(
1985)
Imazalil
Residue
in
Wheat
and
Barley
.
Unpublished
compilation
prepared
by
Janssen
Pharmaceutica.
44
p.

00157188
Janssen
Research
Products
Information
Service
(
1985)
Residue
and
Analytical
Methodology
of
Imazalil
in
Apples
and
Pears
.
Unpublished
compilation.
172
p.

00157189
Van
Leemput,
L.;
Swysen,
E.;
Woestenborghs,
R.;
et
al.
(
1986)
The
Stability
of
Imazalil
derived
Residue
on
Oat
Forage
and
Wheat
Straw
under
Various
Storage
Conditions:
Serial
No.
R
23979/
L17.
Unpublished
study
prepared
by
Janssen
Research
Products
Information
Service.
25
p.

00157190
Van
Leemput,
L.
(
1986)
Letter
sent
to
P.
Ruelene
dated
Feb
4,
1986:
Imazalil­
related
residues
in
forage,
grain
and
straw
samples
grown
from
treated
seeds:
Samples
collected
in
summer
and
winter
of
1985.
Prepared
by
Janssen
Research
Products
Information
Service.
151
p.

40509402
Leigh,
W.
(
1987)
Residues
of
Imazalil
and
Metabolite
T­
824
on
Citrus
Fruits
Following
Postharvest
Application:
Proj.
ID
X1
1988.
Unpublished
study
prepared
by
Pent­
A­
Vate,
Inc.
34
p.

40509403
Leigh,
W.
(
1988)
Residues
of
Imazalil
and
Metabolite
T­
824
on
Citrus
Fruits
and
Citrus
Juice
following
Postharvest
Application:
Proj.
ID
X2
1988.
Unpublished
study
prepared
by
Pent­
A­
Vate,
Inc.,
Biological
Testing
and
Research
Laboratory.
22
p.
Page
46
of
50
42012005
Van
Leemput,
L.
(
1991)
Phase
3
Summary:
Excretion,
Metabolism
and
Tissue
Depletion
of
[
14
Carbon]­
Enilconazole
(.
.
.)
After
Repeated
Oral
Dosing
in
Broiler
Chickens:
Lab
Project
Number:
R23979/
47:
V5388.
Unpublished
study
prepared
by
Janssen
Pharmaceutical
Foundation.
13
p.

42012006
Van
Leemput,
L.
(
1990)
Revised
Phase
3
Summary
of
Reformat
with
MRID
00027532
and
Related
MRID
00084643:
The
Metabolic
Fate
of
Imazalil
on
Oranges:
Lab
Project
No.
R23979/
18:
393.
Unpublished
study
prepared
by
Janssen
Pharmaceutica
N.
V.
12
p.

42012007
Van
Leemput,
L.
(
1990)
Revised
Phase
3
Summary
of
Reformat
with
MRID
00087542
and
Related
MRID
00087543:
The
Metabolic
Fate
of
Imazalil
on
Banana
Plants:
Lab
Project
No.
R23979/
21:
379.
Unpublished
study
prepared
by
Janssen
Pharmaceutica
N.
V.
13
p.

42012008
Reulens,
P.
(
1990)
Revised
Phase
3
Reformat
of
MRID
00027532:
The
Metabolic
Fate
of
Imazalil
on
Oranges:
Lab
Project
No.
R23979/
18:
393.
Unpublished
study
prepared
by
Janssen
Pharmaceutica
N.
V.
7
p.

42012009
Garnier,
A.
(
1990)
Revised
Phase
3
Reformat
of
MRID
00087542
&
Related
MRID
00087543:
The
Metabolic
Fate
of
Imazalil
on
Banana
Plants:
Lab
Project
No.
R
23979/
21:
379.
Unpublished
study
prepared
by
Janssen
Pharmaceutica
N.
V.
52
p.

42058701
Garnier,
A.
(
1991)
Analysis
of
Imazalil­
Derived
Residues
in
Bananas:
Lab
Project
Number:
AGR3.
Unpublished
study
prepared
by
Janssen
Pharmaceutica
N.
V.
777
p.

42348301
Goodwine,
W.
(
1992)
Magnitude
of
Residue:
Imazalil
and
Metabolite
(
R14821)
in
Processing
Fractions
of
Lemons,
Oranges,
and
Grapefruits
Resulting
from
Postharvest
Treatment
with
Fungaflor
500
EC­
Raw
Data
Summary:
Lab
Project
Number:
AGR8.
Unpublished
study
prepared
by
Janssen
Pharmaceutica.
23
p.

42403102
Ruelens,
P.;
Garnier,
A.
(
1992)
Supplement
to
MRIDs
42012008
and
42012009:
Response
to
Deficiencies
Noted
in
EPA
Correspondence
Dated
April
2,
1992:
Lab
Project
Number:
R23979/
FK1347.
Unpublished
study
prepared
by
Janssen
Pharmaceutica.
62
p.

42405501
Goodwine,
W.
(
1992)
Magnitude
of
Residue:
Imazalil
and
Metabolite
R14821
in
Processing
Fractions
of
Lemons,
Oranges,
and
Grapefruits
Resulting
From
Postharvest
Treatment
with
Fungaflor
500
EC­­
Survey
of
Imazalil
and
R14821
Residues
in
Citrus
Oils:
Lab
Project
Number:
AGR8.
Unpublished
study
prepared
by
PENT­
A­
Vate,
Inc.
5
p.

42454801
Van
Dijk,
A.
(
1992)
(
Carbon
14)­
Imazalil:
Distribution,
Degradation,
Metabolism
and
Excretion
After
Repeated
Oral
Administration
to
a
Lactating
Goat:
Lab
Project
Number:
296662:
R23979/
FK1206.
Unpublished
study
prepared
by
RCC
Umweltchemie
AG.
328
p.

42454802
Mannens,
G.
(
1992)
A
Study
on
Milk
and
Tissue
Metabolite
of
Imazalil
in
Lactating
Goat
After
Repeated
Oral
Administration
at
10
mg/
kg/
Day:
Lab
Project
Number:
R
23979/
FK1346.
Unpublished
study
prepared
by
Janssen
Research
Foundation.
55
p.

42454803
Ligtvoet,
T.
(
1992)
A
Validated
Gas
Chromatographic
Method
for
the
Determination
of
Total
Regulable
Residues
of
Imazalil
on
Bananas:
Lab
Project
Number:
AGR
16:
56.
Unpublished
study
prepared
by
Janssen
Research
foundation.
66
p.

42454804
Woestenborghs,
R.
(
1992)
A
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Ligtvoet,
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Garnier,
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Storage
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Woestenborghs,
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Storage
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42755301
Garnier,
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Mannens,
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carbon
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Helmer,
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Magnitude
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in
Spring
Barley
Forage,
Straw
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Grain
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Helmer,
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Magnitude
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Winter
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Forage,
Straw
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Imazalil:
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Nature
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Interim
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Lab
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Nature
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Final
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Lab
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JST/
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274
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43285001
Helmer,
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Magnitude
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Imazalil
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R14821)
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Winter
Wheat
Forage,
Straw
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Grain
Grown
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Treated
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Lab
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Number:
AGR30.
Unpublished
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43965701
Mannens,
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Nature
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Lab
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R023979/
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study
prepared
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Research
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van
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Feasibility
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AG­
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van
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Feasibility
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44455601
van
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Validation
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Two
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44532901
Remmerie,
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Validation
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HPLC
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Results
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GC­
ECD
Method
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44568301
van
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by
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Umweltchemie
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403
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92072019
Van
Leemput,
L.
(
1990)
Janssen
Pharmaceutic
Phase
3
Summary
of
MRID
00087542
and
Related
MRIDs
00087543.
The
Metabolic
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R23979/
21,
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Prepared
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10
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92072020
Van
Leemput,
L.
(
1990)
Janssen
Pharmaceutic
Phase
3
Summary
of
MRID
00027532.
The
Metabolic
Fate
of
Imazalil
on
Oranges:
Report
No.
R23979/
18,
Rec
#
393.
Prepared
by
Janssen
Pharmaceutica.
10
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92072021
Meuldermans,
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(
1990)
Janssen
Pharmaceutic
Phase
3
Summary
of
MRID
00027533
and
Related
MRIDs
00084644.
Plasma
and
Milk
Levels,
Distribution,
Excretion
and
Biotransformation
of
Imazalil
after
Repeated
Administration
to
a
Lactating
Goat:
Report
No.
R23979/
14,
Rec
#
380.
Prepared
by
Janssen
Pharmaceutica.
8
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92072022
Woestenborghs,
R.
(
1990)
Janssen
Pharmaceutic
Phase
3
Summary
of
MRID
00109269.
A
Gas­
liquid
Chromatographic
Method
for
Determining
Total
Regulable
Residues
of
Imazalil
in
Citrus
Fruit
and
Citrus
By­
Products:
Report
Nos.
R23979/
30,
Rec
#'
s
395
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396.
Prepared
by
Janssen
Pharmaceutica.
10
p.

92072023
Woestenborghs,
R.
(
1990)
Janssen
Pharmaceutic
Phase
3
Summary
of
MRID
00127900.
Gas­
liquid
Chromatographic
Method
for
Determining
[
sic]
Total
Regulable
Residues
of
Imazalil
in
Seeds,
Foliage
and
Straw
from
Page
49
of
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Cereals
and
Cotton:
Report
Nos.
R23979/
39
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R23979/
40,
Rec
#'
s
378
and
377.
Prepared
by
Janssen
Pharmaceutica.
8
p.

92072024
Woestenborghs,
R.
(
1990)
Janssen
Pharmaceutic
Phase
3
Summary
of
MRID
00109269.
Electron
Capture
GC
for
Imazalil
and
Two
Metabolites
in
Bovine
Tissues
and
Milk:
Report
Nos.
R23979/
31
and
R23979/
32
Rec
#'
s
386
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387.
Prepared
by
Janssen
Pharmaceutica.
11
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92072025
Van
Leemput,
L.
(
1990)
Janssen
Pharmaceutic
Phase
3
Summary
of
MRID
00157189.
The
Stability
of
Imazalil­
derived
Residue
on
Oat
Forage
and
Wheat
Straw
under
Various
Storage
Conditions:
Report
No.
R23979/
L19
Rec
#
376.
Prepared
by
Janssen
Pharmaceutica.
8
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92072026
Helmer,
D.
(
1990)
Janssen
Pharmaceutic
Phase
3
Summary
of
MRID
00127900
and
Related
MRIDs
00150020,
00157190.
Determinations
of
Imazalil
and
T­
824
Residue
in
Barley
Forage,
Straw
and
Grain
Grown
from
Imazalil
Treated
Seed:
Report
No.
79/
84,
Rec
#
374.
Prepared
by
Janssen
Pharmaceutica.
11
p.

92072027
Helmer,
D.
(
1990)
Janssen
Pharmaceutic
Phase
3
Summary
of
MRID
40509402
and
Related
MRIDs
40509403.
Residues
of
Imazalil
and
Metabolite
T­
824
on
Citrus
Fruits
following
Postharvest
Application:
Report
No.
X1,
1988,
Rec
#
405.
Prepared
by
PENT­
A­
VATE,
INC.
17
p.

92072028
Helmer,
D.
(
1990)
Janssen
Pharmaceutic
Phase
3
Summary
of
MRID
00127900.
Determinations
of
Imazalil
and
T­
824
Residue
in
Cotton
Seed
and
Foliage
Grown
from
Imazalil
Treated
Seed:
Report
No.
R23979/
39,
Rec
#
378.
Prepared
by
Janssen
Pharmaceutica.
8
p.

92072029
Helmer,
D.
(
1990)
Janssen
Pharmaceutic
Phase
3
Summary
of
MRID
00127900
and
Related
MRIDs
00157190,
00150020.
Determinations
of
Imazalil
and
T­
824
Residue
in
Wheat
Forage,
Straw
and
Grain
Grown
from
Imazalil
Treated
Seed:
Report
No.
860204,
Rec
#
375.
Prepared
by
Janssen
Pharmaceutica.
10
p.

92072030
Helmer,
D.
(
1990)
Janssen
Pharmaceutic
Phase
3
Summary
of
MRID
40509403.
Residues
of
Imazalil
and
Metabolite
T­
824
on
Processed
Citrus
Fruits
following
Postharvest
Application:
Report
No.
X1,
Rec.
#
405.
Prepared
by
PENT­
A­
VATE,
INC.
8
p.

92072035
Goodwine,
W.
(
1990)
Janssen
Pharmaceutic
Phase
3
Summary
of
MRID
00157188.
On
the
Fate
of
Imazalil
on
Golden
Delicious
Apples
during
a
Controlled
Atmosphere
Storage
for
Up
to
Seven
Months:
Report
No.
R23979/
L9,
Rec
#
400.
Prepared
by
Janssen
Pharmaceutica.
7
p.

92072036
Garnier,
A.
(
1990)
Janssen
Pharmaceutic
Phase
3
Reformat
of
MRID
00087542
and
Related
MRIDs
00087543.
The
Metabolic
Fate
of
Imazalil
on
Banana
Plants:
Report
No.
R23979/
21,
Rec
#
379.
Prepared
by
Janssen
Pharmaceutica.
36
p.

92072037
Ruelens,
P.
(
1990)
Janssen
Pharmaceutic
Phase
3
Reformat
of
MRID
00027532.
The
Metabolic
Fate
of
Imazalil
on
Oranges:
Report
No.
R23979/
18,
Rec
#
393.
Prepared
by
Janssen
Pharmaceutica.
51
p.

92072038
Garnier,
A.
(
1990)
Janssen
Pharmaceutic
Phase
3
Reformat
of
MRID
00027533
and
Related
MRIDs
00084644.
Plasma
and
Milk
Levels,
Distribution,
Excretion
and
Biotransformation
of
Imazalil
after
Repeated
Administration
to
a
Lactating
Goat:
Report
No.
R23979/
14,
Rec
#
380.
Prepared
by
Janssen
Pharmaceutica.
78
p.

92072039
Woestenborghs,
R.;
Van
Leemput,
L.
(
1990)
Janssen
Pharmaceutic
Phase
3
Reformat
of
MRID
00127900.
Determinations
of
Imazalil
and
T­
824
Residue
in
Cotton
Seed
and
Foliage
Grown
from
Imazalil
Treated
Seed:
Report
No.
R23979/
39
Rec
#
378.
Prepared
by
Janssen
Pharmaceutica
N.
V.
18
p.
Page
50
of
50
92072040
Leigh,
W.
(
1990)
Janssen
Pharmaceutic
Phase
3
Reformat
of
MRID
40509402
and
Related
MRIDs
40509403.
Residues
of
Imazalil
and
Metabolite
T­
824
on
Citrus
Fruits
Following
Postharvest
Application:
Report
No.
X1,
1988,
Rec
#
405.
Prepared
by
Janssen
Pharmaceutica.
137
p.

92072041
Helmer,
D.;
Goodwine,
W.
(
1990)
Janssen
Pharmaceutic
Phase
3
Reformat
of
MRID
00157900
and
Related
MRIDs
00127900,
00157190.
Determinations
of
Imazalil
and
T­
824
Residue
in
Wheat
Forage,
Straw
and
Grain
Grown
from
Imazalil
Treated
Seed:
Report
No.
860204,
Rec
#
375.
Prepared
by
Janssen
Pharmaceutica,
N.
V.
148
p.

92072042
Helmer,
D.;
Goodwine,
W.
(
1990)
Janssen
Pharmaceutic
Phase
3
Reformat
of
MRID
00127900
and
Related
MRIDs
00157190,
00150026.
Determinations
of
Imazalil
and
T­
824
Residue
in
Barley
Forage,
Straw
and
Grain
Grown
from
Imazalil
Treated
Seed:
Report
No.
79/
84,
Rec.
#
374.
Prepared
by
Janssen
Pharmaceutica
N.
V.
146
p.
