Document ID: EPA-HQ-OPP-2003-0268-0005
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2003-07-30T04:00Z

UNITED
STATES
ENVIRONMENTAL
PROTECTION
AGENCY
WASHINGTON,
D.
C.
20460
OFFICE
OF
PREVENTION,
PESTICIDES
AND
TOXIC
SUBSTANCES
November
13,
2001
MEMORANDUM
SUBJECT:
Dinocap.
(
Chemical
ID
No.
036001,
Case
No.
2200).
Product
and
Residue
Chemistry
Chapters
for
the
Dinocap
Reregistration
Eligibility
Decision
Document.
No
MRID
#.
DP
Barcode
No.
D278613.

FROM:
Felecia
Fort,
Chemist
Reregistration
Branch
1
Health
Effects
Division
(
7509C)

THRU:
Whang
Phang,
Ph.
D.,
Branch
Senior
Scientist
Reregistration
Branch
1
Health
Effects
Division
(
7509C)

TO:
Christina
Swartz
Reregistration
Branch
1
Health
Effects
Division
(
7509C)

and
Margaret
Rice
Reregistration
Branch
II
Special
Review
and
Reregistration
Division
(
7508W)

Attached
are
the
Product
and
Residue
Chemistry
chapters
for
the
Dinocap
Reregistration
Eligibility
Decision
(
RED)
Document.
The
information
contained
within
this
document
was
reviewed
by
Dynamac
Corporation
under
the
supervision
of
RRB1/
HED.
The
data
assessment
has
undergone
secondary
review
in
the
HED
and
has
been
revised
to
reflect
Agency
policies.

HED
makes
the
following
conclusions
with
respect
to
the
Product
and
Residue
chemistry
chapters:
2
Product
Chemistry
One
product,
the
Rohm
and
Haas
92.5%
T/
TGAI,
is
subject
to
a
reregistration
eligibility
decision.
Most
pertinent
data
requirements
are
satisfied
except
data
concerning
UV/
visible
absorption
(
OPPTS
830.7050)
are
required.
Provided
that
the
registrant
submits
the
data
required
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
dinocap
with
respect
to
product
chemistry
data
requirements.

Residue
Chemistry
There
are
currently
no
registered
food/
feed
uses
of
dinocap
in
the
U.
S.
The
established
dinocap
tolerances
for
food
and
feed
commodities
have
been
revoked
except
those
for
apples
and
grapes.
Rohm
and
Haas
Company,
the
basic
producer,
intends
to
support
tolerances
for
dinocap
residues
in/
on
apples
and
grapes
to
permit
legal
importation
of
these
commodities
into
the
U.
S.

Tolerances
for
dinocap
are
currently
expressed
in
terms
of
combined
negligible
residues
of
a
fungicide
and
insecticide
that
is
a
mixture
of
2,4­
dinitro­
6­
octylphenyl
crotonate
and
2,6­
dinitro­
4­
octylphenyl
crotonate
in/
on
apples
and
grapes
at
0.1
ppm
[
40
CFR
§
180.341(
a)].

To
fulfill
reregistration
requirements,
the
registrant
must
submit
a
description
of
the
uses
of
dinocap
in
all
foreign
countries
in
which
dinocap
is
marketed
for
use
on
apples
and
grapes
that
may
be
exported
to
the
U.
S.
It
is
preferable
to
submit
copies
of
the
labels
(
which
have
been
translated
to
English).
The
information
must
include,
but
is
not
limited
to,
the
maximum
single
application
rate,
the
maximum
annual
application
rate,
application
timing
(
as
it
relates
to
the
plant
growth
stage),
retreatment
interval(
s),
application
tank­
mix
preparation,
volume
of
spray
mix
per
unit
area,
application
equipment,
and
the
pre­
harvest
interval
(
PHI).
Application
rates
should
be
expressed
in
units
of
pounds
of
active
ingredient
per
acre
(
or
kilograms
of
active
ingredient
per
hectare).

The
qualitative
nature
of
the
residue
in
plants
is
not
adequately
understood.
To
fulfill
reregistration
requirements,
the
registrant
must
submit
either
an
apple
or
a
grape
metabolism
study
to
determine
the
qualitative
metabolic
fate
of
dinocap
on
a
fruit
crop
when
it
has
been
applied
under
conditions
similar
to
the
foreign
uses.

The
qualitative
nature
of
the
residue
in
livestock
is
not
adequately
understood.
Because
wet
apple
pomace
is
a
livestock
feed
item,
the
registrant
must
submit
a
ruminant
metabolism
study
to
fulfill
reregistration
requirements.
If
Rohm
and
Haas
wishes
to
request
a
waiver
for
the
ruminant
metabolism
study,
they
must
convincingly
document
that
it
is
unlikely
that
imported
apples
or
wet
apple
pomace
would
be
significant
feed
items
in
the
U.
S.
or
exporting
countries
and/
or
that
there
are
not
significant
imports
of
livestock
commodities
from
the
exporting
countries
into
the
U.
S.
A
poultry
metabolism
study
is
not
required
because
there
are
no
poultry
feed
items
derived
from
the
imported
crops
for
which
dinocap
uses
are
being
supported.
3
An
adequate
enforcement
method
exists;
however,
the
method
must
be
revised
to
remove
the
use
of
benzene.
Additionally,
when
the
required
plant
metabolism
study
has
been
received,
and
the
residues
of
concern
have
been
determined,
the
Agency
may
require
new
plant
residue
analytical
method(
s)
for
the
purposes
of
data
collection
and
tolerance
enforcement.
The
requirement
for
animal
residue
analytical
methods
is
reserved
pending
submission/
review
of
the
required
ruminant
metabolism
study
and
determination
of
the
need
for
animal
tolerances.

No
acceptable
storage
stability
data
are
available
for
plant
commodities
to
fulfill
reregistration
requirements.
The
registrant
must
submit
data
pertaining
to
the
storage
stability
of
residues
of
the
parent
and
all
residues
of
regulatory
and/
or
risk
concern
in/
on
apples
and
grapes.
Storage
stability
studies
must
reflect
the
storage
conditions
and
intervals
of
samples
used
in
the
required
plant
metabolism
and
magnitude
of
the
residue
studies.
Storage
stability
data
are
not
needed
for
analytes
not
known
to
be
labile
or
volatile
if
samples
are
stored
for
less
than
4­
6
months
for
the
metabolism
study
or
30
days
for
magnitude
of
the
residue
studies.

The
requirement
for
storage
stability
data
for
animal
commodities
is
reserved
pending
submission/
review
of
the
required
ruminant
metabolism
study
and
determination
of
the
need
for
animal
tolerances.

The
reregistration
requirements
for
magnitude
of
the
residue
in/
on
imported
apples
and
grapes
have
not
been
addressed.
Field
residue
data
must
be
submitted
reflecting
the
maximum
use
patterns
for
representative
dinocap
formulations
on
apples
and
grapes
to
be
exported
to
the
U.
S.
It
is
recommended
that
the
registrant
submit
a
protocol
before
generating
field
trial
data
for
these
commodities.

The
registrant
must
also
conduct
processing
studies
on
apples
and
grapes.
The
Agency
has
determined
that
processing
studies
must
be
conducted
to
support
import
tolerances
if
the
imported
commodities
are
likely
to
be
processed
once
they
have
been
imported
into
the
U.
S.
or
if
processed
commodities
are
imported
into
the
U.
S..
In
the
required
processing
studies,
the
raw
agricultural
commodity
(
RAC)
should
be
processed
in
a
manner
simulating
typical
commercial
practice.
The
RAC
should
have
detectable
residues
so
that
a
concentration
factor
may
be
calculated.
Exaggerated
rates
and/
or
reduced
preharvest
intervals
may
be
necessary
to
ensure
that
the
RAC
to
be
processed
contains
sufficient
residues.
The
registrant
is
advised
to
consult
the
Agency
if
they
believe
processing
studies
are
not
necessary
for
imported
apples
or
grapes.

The
requirement
for
a
ruminant
feeding
study
is
reserved
pending
submission/
review
of
the
requested
ruminant
metabolism
study
and
determination
of
terminal
residues
of
concern.
A
poultry
feeding
study
is
not
required
because
there
are
no
poultry
feed
items
derived
from
the
imported
crops
for
which
dinocap
uses
are
being
supported.

cc:
List
B
Rereg.
File,
SRRD
RDI:
WPhang
11/
12/
01,
CHEMSAC
11/
7/
01
7509C:
FFort:
RRB1:
CM2:
Rm
722H:
703
305­
7478:
11/
07/
2001
4
O
2
N
O
NO
2
R
O
CH
3
O
2
N
O
R
O
CH
3
NO
2
R
=
CH
3
CH
3
or
CH
3
CH
3
or
CH
3
CH
3
DINOCAP
AND
ITS
COMPONENTS
REREGISTRATION
ELIGIBILITY
DECISION:

PRODUCT
CHEMISTRY
CONSIDERATIONS
PC
Codes
036001,
36002,
and
36003;
Case
No.
2200
DESCRIPTION
OF
CHEMICAL
Dinocap
(
PC
Code
036001)
is
the
common
name
for
a
mixture
of
2,4­
dinitro­
6­
octylphenyl
crotonate,
2,6­
dinitro­
4­
octylphenyl
crotonate,
and
nitrooctylphenols
(
principally
dinitro),
in
which
the
octyl
groups
are
a
mixture
of
1­
methylheptyl,
1­
ethylhexyl,
and
1­
propylpentyl
isomers.
The
other
two
active
ingredients
included
in
the
case,
which
pertain
to
specific
components
of
the
dinocap
mixture,
2,4­
dinitro­
6­
octylphenyl
crotonate
(
PC
Code
036002)
and
2,6­
dinitro­
4­
octylphenyl
crotonate
(
PC
Code
036003),
have
been
canceled.
Dinocap
has
limited
use
as
a
miticide,
but
its
main
pesticidal
classification
is
as
a
fungicide
for
the
control
of
powdery
mildew
on
ornamental
plants.
There
are
currently
no
registered
food/
feed
uses
of
dinocap
in
the
U.
S.
The
established
dinocap
tolerances
for
food
and
feed
commodities
have
been
revoked
except
for
those
for
apples
and
grapes.
Rohm
and
Haas
Company
intends
to
support
tolerances
for
dinocap
residues
in/
on
apples
and
grapes
to
permit
legal
importation
of
these
commodities
into
the
U.
S.

Empirical
Formula:
C18H24N2O6
Molecular
Weight:
364.39
CAS
Registry
No.:
39300­
45­
3
PC
Code:
036001
5
IDENTIFICATION
OF
ACTIVE
INGREDIENT
Dinocap
is
a
dark
brown
liquid
with
a
boiling
point
of
138­
140
C
at
0.05
mm
Hg,
bulk
density
of
1.10
g/
mL,
vapor
pressure
of
3.33
x
10­
6
Pa
at
25
C,
and
octanol/
water
partition
coefficient
(
Pow)
of
34,300
(
log
Pow
=
4.54)
at
20
C.
Dinocap
is
practically
insoluble
in
water
(<
0.1
ppm)
and
is
incompatible
with
oil
and
oil­
based
sprays.
Dinocap
is
soluble
in
most
organic
solvents,
including
acetone,
heptane,
methanol,
and
octane.

MANUFACTURING­
USE
PRODUCTS
A
search
of
the
Reference
Files
System
(
REFS)
conducted
12/
22/
99
identified
a
single
dinocap
manufacturing­
use
product
(
MP)
registered
under
PC
Code
036001:
the
Rohm
and
Haas
Company
92.5%
technical
(
T;
EPA
Reg.
No.
707­
95).
Because
dinocap
is
a
List
B
chemical,
only
the
92.5%
T/
TGAI
is
subject
to
a
reregistration
eligibility
decision.

REGULATORY
BACKGROUND
The
Dinocap
Phase
4
Review
dated
1/
30/
91
by
J.
Smith
determined
that
additional
data
were
required
concerning
stability,
octanol/
water
partition
coefficient,
and
vapor
pressure
(
OPPTS
830.6313,
7550,
and
7950);
all
other
product
chemistry
data
submissions
were
determined
to
be
acceptable
for
Phase
5
review.
Most
of
the
submissions
cited
in
the
Phase
4
Review
were
reviewed
in
support
of
a
revised
manufacturing
process
for
the
dinocap
technical
(
CBRS
No.
3352,
3/
10/
88,
R.
Loranger).

The
current
status
of
the
product
chemistry
data
requirements
for
the
dinocap
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
data
requirements
are
satisfied
for
the
Rohm
and
Haas
92.5%
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
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
dinocap
with
respect
to
product
chemistry
data
requirements.
6
AGENCY
MEMORANDA
CITED
IN
THIS
DOCUMENT
CBRS
No(
s).:
3352
Subject:
EPA
Reg.
No.
707­
95.
Amended
registration
for
dinocap
(
Karathane
®
)
technical.
Revised
manufacturing
process
to
increase
purity.
From:
R.
Loranger
To:
D.
Edwards
and
P.
Parsons
Dated:
3/
10/
88
MRID(
s):
40492901
and
40492902
CBRS
No(
s).:
9964
DP
Barcode(
s)
D178967
Subject:
Dinocap.
Case
No.
2200.
Request
for
waiver
of
data
requirements.
From:
F.
Fort
To:
S.
Rathman/
B.
Briscoe
Dated:
7/
14/
92
MRID(
s):
00147266
(
Accession
No.
257924)

CBRS
No(
s).:
11211
DP
Barcode(
s)
D186965
Subject:
Reregistration
of
Dinocap.
Rohm
&
Haas
11/
6/
92
Product
Chemistry
[
63­
9
&
­
13]
response
to
Phase
4
9/
16/
91
DCI.
Rereg
Case
2200;
Chemical
36001.
Action:
627
Generic
Data
Submission
S433765.
From:
K.
Dockter
To:
B.
Briscoe/
S.
Rathman
Dated:
2/
18/
93
MRID(
s):
42546601
and
42546602
DP
Barcode(
s)
D274784
Subject:
Product
Chemistry
Data
in
Support
of
Reregistration
of
the
Rohm
and
Haas
Company
92.5%
T
(
EPA
Reg.
No.
707­
95)
From:
F.
Fort
To:
M.
Rice
Dated:
11/
07/
01
MRID(
s):
40800901­
40800903
7
PRODUCT
CHEMISTRY
CITATIONS
Bibliographic
citations
include
only
MRIDs
containing
data
which
fulfill
data
requirements.

References
(
cited):

00147266
Rohm
and
Haas
Co.
(
1985)
Product
Chemistry
Data
of
Karathane:
Water
Solubility,
Vapor
Pressure,
and
Octanol/
Water
Partition
Coefficient
.
Unpublished
compilation.
24
p.

40492901
Berrier,
J.
(
1987)
Karathane
Technical
­
Physical
and
Chemical
Characteristics:
RWN­
87­
151.
Unpublished
compilation
prepared
by
Rohm
and
Haas
Co.
41
p.

40492902
Berrier,
J.
(
1987)
Karathane
Technical
­
Product
Identity
and
Composition;
Analysis
and
Certification
of
Product
Ingredients:
RWN­
87­
150.
Unpublished
study
prepared
by
Rohm
and
Haas
Co.
223
p.

40800901
Nichols,
R.
(
1988)
Addendum
to
Karathane
Technical
Product
Chemistry
(
RWN­
87­
150):
Project
I.
D.
No.
RWN­
88­
089.
Unpublished
compilation
prepared
by
Rohm
and
Haas
Co.
70
p.

40800902
Doshi,
D.
(
1986)
Reversed
Phase
HPLC
Analysis
of
Karathane
Technical
for
Active
Ingredients
(
Crotonates):
Project
I.
D.
No.
86­
10­
1.
Unpublished
study
prepared
by
Rohm
and
Haas
Co.
15
p.
40800903
Berrios,
E.
(
1987)
Reverse
Phase
HPLC
Analysis
of
Purified
Karathane
Technical
for
Dinitrooctyl
Phenols:
Project
I.
D.
No.
87­
52­
01.
Unpublished
study
prepared
by
Rohm
and
Haas
Co.
11
p.

42546601
Batra,
R.
(
1992)
Addendum
to
Product
Chemistry
Series
63:
Physical
and
Chemical
Characterization
Studies
of
Karathane
Technical:
63­
13
Sensitivity
to
Metal
and
Metal
Ions:
Lab
Project
Number:
APR/
SH­
92­
196.
Unpublished
study
prepared
by
Rohm
and
Haas
Co.
69
p.

42546602
Yeh,
L.
(
1992)
Dinocap
­
Vapor
Pressure:
Lab
Project
Number:
1960­
92­
0052­
AS:
1960­
92­
0052­
AS­
001:
34P­
92­
17.
Unpublished
study
prepared
by
Ricerca,
Inc.
79
p.
8
Case
No.
2200
Chemical
No.
036001
Case
Name:
Dinocap,
and
its
Components
Registrant:
Rohm
and
Haas
Company
Product(
s):
92.5%
T
(
EPA
Reg.
No.
707­
95)

PRODUCT
CHEMISTRY
DATA
SUMMARY
Guideline
Number
Requirement
Are
Data
Requirements
Fulfilled?
1
MRID
Number
2
830.1550
Product
identity
and
composition
Y
40492902
3
830.1600
Description
of
materials
used
to
produce
the
product
Y
40492902
3
830.1620
Description
of
production
process
Y
40492902
3,
40800901
4
830.1670
Discussion
of
formation
of
impurities
Y
40492902
3,
40800901
4
830.1700
Preliminary
analysis
Y
40492902
3,
40800901
4
830.1750
Certified
limits
Y
40492902
3
830.1800
Enforcement
analytical
method
Y
40492902
3,
40800902
4,
40800903
4
830.6302
Color
Y
40492901
3
830.6303
Physical
state
Y
40492901
3
830.6304
Odor
Y
40492901
3
830.6313
Stability
to
normal
and
elevated
temperatures,
metals,
and
metal
ions
Y
40492901
3,
42546601
5
830.7000
pH
Y
40492901
3
830.7050
UV/
visible
absorption
N
6
830.7200
Melting
point/
melting
range
N/
A
7
830.7220
Boiling
point/
boiling
range
Y
40492901
3
830.7300
Density/
relative
density/
bulk
density
Y
40492901
3
830.7370
Dissociation
constants
in
water
Y
40492901
3
830.7550
Partition
coefficient
(
n­
octanol/
water),
shake
flask
method
Y
40492901
3,
00147266
8
830.7840
Water
solubility:
Column
elution
method;
shake
flask
method
Y
40492901
3
830.7950
Vapor
pressure
Y
40492901
3,
42546602
5
1
Y
=
Yes;
N
=
No;
N/
A
=
Not
Applicable.

2
Bolded
references
were
determined
to
be
acceptable
for
Phase
5
review
under
the
Dinocap
Phase
4
Review
dated
1/
30/
91
by
J.
Smith
and
were
reviewed
as
noted;
all
other
references
were
reviewed
as
noted.

3
CBRS
No.
3352,
3/
10/
88,
R.
Loranger
4
D278784,
11/
07/
01,
F.
Fort
5
CBRS
No.
11211,
D186965,
2/
18/
93,
K.
Dockter.

6
The
OPPTS
Series
830,
Product
Properties
Test
Guidelines
require
data
pertaining
to
UV/
visible
absorption
for
the
PAI.

7
Data
are
not
required
because
the
TGAI
is
a
liquid
at
room
temperature.

8
CBRS
No.
9964,
D178967,
7/
14/
92,
F.
Fort.
DINOCAP,
AND
ITS
COMPONENTS
REREGISTRATION
ELIGIBILITY
DECISION
RESIDUE
CHEMISTRY
CONSIDERATIONS
PC
Codes
036001,
036002,
and
036003;
Case
2200
TABLE
OF
CONTENTS
page
INTRODUCTION
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1
REGULATORY
BACKGROUND
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1
SUMMARY
OF
SCIENCE
FINDINGS
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2
GLN
860.1200:
Directions
for
Use
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2
GLN
860.1300:
Nature
of
the
Residue
­
Plants
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3
GLN
860.1300:
Nature
of
the
Residue
­
Animals
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3
GLN
860.1340:
Residue
Analytical
Methods
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3
GLN
860.1360:
Multiresidue
Methods
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4
GLN
860.1380:
Storage
Stability
Data
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4
GLN
860.1500:
Crop
Field
Trials
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4
GLN
860.1520:
Processed
Food/
Feed
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5
GLN
860.1480:
Meat,
Milk,
Poultry,
Eggs
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5
GLN
860.1400:
Water,
Fish,
and
Irrigated
Crops
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5
GLN
860.1460:
Food
Handling
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5
GLN
860.1850
and
860.1900:
Confined/
Field
Accumulation
in
Rotational
Crops
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6
TOLERANCE
REASSESSMENT
SUMMARY
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10
Tolerances
Listed
Under
40
CFR
§
180.341(
a)
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10
CODEX
HARMONIZATION
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10
DIETARY
EXPOSURE
ASSESSMENT
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10
AGENCY
MEMORANDA
RELEVANT
TO
REREGISTRATION
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11
DINOCAP,
AND
ITS
COMPONENTS
REREGISTRATION
ELIGIBILITY
DECISION
RESIDUE
CHEMISTRY
CONSIDERATIONS
PC
Codes
036001,
036002,
and
036003;
Case
2200
INTRODUCTION
Dinocap
(
PC
Code
036001)
is
the
common
name
for
a
mixture
of
2,4­
dinitro­
6­
octylphenyl
crotonate,
2,6­
dinitro­
4­
octylphenyl
crotonate,
and
nitrooctylphenols
(
principally
dinitro),
in
which
the
octyl
groups
are
a
mixture
of
1­
methylheptyl,
1­
ethylhexyl,
and
1­
propylpentyl
isomers.
Products
containing
the
two
individual
isomers,
which
pertain
to
specific
components
of
the
dinocap
mixture,
2,4­
dinitro­
6­
octylphenyl
crotonate
(
PC
Code
036002)
and
2,6­
dinitro­
4­
octylphenyl
crotonate
(
PC
Code
036003),
have
been
canceled.
Dinocap
has
limited
use
as
a
miticide,
but
its
main
pesticidal
classification
is
as
a
fungicide
for
the
control
of
powdery
mildew
on
ornamental
plants.
There
are
currently
no
registered
food/
feed
uses
of
dinocap
in
the
U.
S.
The
established
dinocap
tolerances
for
food
and
feed
commodities
have
been
revoked
except
for
those
for
apples
and
grapes.
Rohm
and
Haas
Company,
the
basic
producer,
intends
to
support
tolerances
for
dinocap
residues
in/
on
apples
and
grapes
to
permit
legal
importation
of
these
commodities
into
the
U.
S.
This
document
presents
an
overall
and
up­
to­
date
Residue
Chemistry
Science
Assessment
with
respect
to
the
reregistration
of
dinocap,
and
specifically
addresses
data
requirements
for
support
of
import
tolerances
on
apples
and
grapes.

REGULATORY
BACKGROUND
Dinocap,
a
List
B
chemical,
was
the
subject
of
a
Phase
4
Review
dated
1/
30/
91
and
a
Data­
Call­
In
Notice
(
DCI)
issued
9/
10/
91.
At
that
time
Rohm
and
Haas
had
indicated
that
they
intended
to
amend
registrations
to
drop
all
food/
feed
uses
for
end­
use
products
(
EPs).
In
the
Phase
4
Review,
data
were
required
under
residue
chemistry
guidelines
pending
submission
of
the
required
amendment
forms
and
revised
labels
for
all
EPs
confirming
that
food/
feed
uses
had
been
removed.
In
their
90­
day
response
to
the
Phase
4
DCI
(
DP
Barcode
D178967,
7/
14/
92,
F.
Fort),
Rohm
and
Haas
requested
a
waiver
of
residue
chemistry
data
requirements
based
on
their
intention
to
delete
all
food/
feed
uses
from
their
product
labels.
The
registrant
subsequently
requested
that
the
Agency
retain
dinocap
tolerances
for
apples
and
grapes
as
import
tolerances
(
DP
Barcode
D198079,
2/
24/
94,
M.
Metzger).
Following
cancellation
by
Rohm
and
Haas
of
all
dinocap
food/
feed
uses
registered
in
the
U.
S.,
the
Agency
revoked
all
dinocap
tolerances
except
those
for
apples
and
grapes
(
63
FR
206,
10/
26/
98).

Tolerances
for
dinocap
are
currently
expressed
in
terms
of
combined
negligible
residues
of
a
fungicide
and
insecticide
that
is
a
mixture
of
2,4­
dinitro­
6­
octylphenyl
crotonate
and
2,6­
dinitro­
4­
octylphenyl
crotonate
in/
on
apples
and
grapes
at
0.1
ppm
[
40
CFR
§
180.341(
a)].

Dinocap
was
the
subject
of
a
Special
Review
because
of
Agency
concerns
about
developmental
toxicity.
The
PD
1
was
published
on
1/
9/
85
(
50
FR
1119)
and
the
PD
2/
3
on
10/
29/
86
(
51
FR
2
39577).
Special
Review
was
concluded
with
the
publication
of
the
PD
4
on
2/
6/
89
(
54
FR
5908).
In
the
PD
4,
the
Agency
required
that
all
dinocap
labels
be
revised
to
include
appropriate
health
hazard
statements
and
to
require
the
use
of
additional
protective
clothing
and
equipment
for
mixer/
loaders
and
applicators.

A
tabular
summary
of
the
residue
chemistry
science
assessments
for
reregistration
of
dinocap
is
presented
in
Table
A.

SUMMARY
OF
SCIENCE
FINDINGS
GLN
860.1200:
Directions
for
Use
A
search
of
the
Agency's
Reference
Files
System
(
REFS)
on
10/
04/
01,
indicated
that
there
are
no
registered
dinocap
EPs
with
food/
feed
uses.
The
only
active
products
containing
dinocap
are
registered
to
Rohm
and
Haas
for
use
on
ornamental
crops.

To
fulfill
reregistration
requirements,
the
registrant
must
submit
a
description
of
the
uses
of
dinocap
in
all
foreign
countries
in
which
dinocap
is
marketed
for
use
on
apples
and
grapes
that
may
be
exported
to
the
U.
S.
It
is
preferable
to
submit
copies
of
the
labels
(
which
have
been
translated
to
English).
The
information
must
include,
but
is
not
limited
to,
the
maximum
single
application
rate,
the
maximum
annual
application
rate,
application
timing
(
as
it
relates
to
the
plant
growth
stage),
retreatment
interval(
s),
application
tank­
mix
preparation,
volume
of
spray
mix
per
unit
area,
application
equipment,
and
the
pre­
harvest
interval
(
PHI).
Application
rates
should
be
expressed
in
units
of
pounds
of
active
ingredient
per
acre
(
or
kilograms
of
active
ingredient
per
hectare).

GLN
860.1300:
Nature
of
the
Residue
­
Plants
The
qualitative
nature
of
the
residue
in
plants
is
not
adequately
understood.
To
fulfill
reregistration
requirements,
the
registrant
must
submit
either
an
apple
or
a
grape
metabolism
study
to
determine
the
qualitative
metabolic
fate
of
dinocap
on
a
fruit
crop
when
it
has
been
applied
under
conditions
similar
to
the
foreign
uses.

In
conjunction
with
a
defunct
petition
(
PP#
9F0847)
for
the
establishment
of
dinocap
tolerances
on
cucurbits,
pome
fruits,
small
fruits,
stone
fruits,
and
strawberries,
the
results
of
a
series
of
cucumber
metabolism
studies
were
reported
(
9/
15/
69
memo
of
E.
Gunderson).
Based
on
separate
studies
performed
on
rind
and
pulp,
dinocap
residues
were
reported
to
be
primarily
surface
in
nature
with
terminal
residues
consisting
of
dinitrooctylphenyl
crotonates
and
related
dinitrooctylphenols;
quantitative
data
were
not
provided.
3
GLN
860.1300:
Nature
of
the
Residue
­
Livestock
The
qualitative
nature
of
the
residue
in
livestock
is
not
adequately
understood.
Under
current
policy,
the
Agency
considers
all
feed
items
included
in
Table
1
of
860.1000
to
be
feed
items
for
import
tolerance
purposes.
Because
wet
apple
pomace
is
a
livestock
feed
item,
the
registrant
must
submit
a
ruminant
metabolism
study
to
fulfill
reregistration
requirements.
If
Rohm
and
Haas
wishes
to
request
a
waiver
for
the
ruminant
metabolism
study,
they
must
convincingly
document
that
it
is
unlikely
that
imported
apples
or
wet
apple
pomace
would
be
significant
feed
items
in
the
U.
S.
or
exporting
countries
and/
or
that
there
are
not
significant
imports
of
livestock
commodities
from
the
exporting
countries
into
the
U.
S.

A
poultry
metabolism
study
is
not
required
because
there
are
no
poultry
feed
items
derived
from
the
imported
crops
for
which
dinocap
uses
are
being
supported.

GLN
860.1340:
Residue
Analytical
Methods
Plant
commodities:
The
Pesticide
Analytical
Manual
(
PAM)
Volume
II
lists
a
colorimetric
method
(
designated
as
Method
I,
Pesticide
Reg.
Sec.
180.341)
for
the
determination
of
dinocap
residues
in/
on
plant
(
caneberries,
fruits,
and
vegetables)
commodities.
Using
this
method,
dinocap
residues
are
extracted
with
benzene
and
hydrolyzed
with
pyridine
to
convert
dinitrophenyl
crotonates
to
the
corresponding
dinitrophenols.
Following
alumina
column
cleanup,
steam
distillation,
and
extraction
with
methylene
chloride,
the
dinitrooctylphenol
residues
are
converted
with
pyridine
to
the
corresponding
phenolates.
Residues
are
quantitated
with
a
spectrophotometer
at
442
nm.
The
reported
sensitivity
of
the
method
is
0.1
ppm.
This
method
must
be
revised
to
remove
the
use
of
benzene.
When
the
required
plant
metabolism
study
has
been
received,
and
the
residues
of
concern
have
been
determined,
the
Agency
may
require
new
plant
residue
analytical
method(
s)
for
the
purposes
of
data
collection
and
tolerance
enforcement.

Animal
commodities:
Enforcement
analytical
methods
are
not
available
for
dinocap
residues
in
animal
commodities.
The
requirement
for
animal
residue
analytical
methods
is
reserved
pending
submission/
review
of
the
required
ruminant
metabolism
study
and
determination
of
the
need
for
animal
tolerances.

GLN
860.1360:
Multiresidue
Methods
The
10/
99
FDA
PESTDATA
database
(
PAM
Volume
I,
Appendix
I)
indicates
that
dinocap
residues
are
completely
recovered
(>
80%)
using
Multiresidue
Methods
Section
302
(
Luke
Method;
Protocol
D)
but
are
only
partially
recovered
(
50­
80%)
using
Multiresidue
Methods
Sections
303
(
Mills,
Onley,
and
Gaither;
Protocol
E,
nonfatty)
and
304
(
Mills,
fatty
food).
The
Agency
may
require
additional
multiresidue
methods
data
when
the
required
plant
metabolism
study
has
been
received
and
the
residues
of
concern
have
been
determined.
4
GLN
860.1380:
Storage
Stability
Data
Plant
commodities:
No
acceptable
storage
stability
data
are
available
for
plant
commodities
to
fulfill
reregistration
requirements.
The
registrant
must
submit
data
pertaining
to
the
storage
stability
of
residues
of
the
parent
and
all
residues
of
regulatory
and/
or
risk
concern
in/
on
apples
and
grapes.
Storage
stability
studies
must
reflect
the
storage
conditions
and
intervals
of
samples
used
in
the
required
plant
metabolism
and
magnitude
of
the
residue
studies.
Storage
stability
data
are
not
needed
for
analytes
not
known
to
be
labile
or
volatile
if
samples
are
stored
for
less
than
4­
6
months
for
the
metabolism
study
or
30
days
for
magnitude
of
the
residue
studies.

Animal
commodities:
The
requirement
for
storage
stability
data
for
animal
commodities
is
reserved
pending
submission/
review
of
the
required
ruminant
metabolism
study
and
determination
of
the
need
for
animal
tolerances.

GLN
860.1500:
Crop
Field
Trials
The
reregistration
requirements
for
magnitude
of
the
residue
in/
on
imported
apples
and
grapes
have
not
been
addressed.
Field
residue
data
must
be
submitted
reflecting
the
maximum
use
patterns
for
representative
dinocap
formulations
on
apples
and
grapes
to
be
exported
to
the
U.
S.
Because
Rohm
and
Haas
has
not
provided
any
use
pattern
data
or
indicated
in
which
countries
dinocap
is
used
or
intended
to
be
used
on
apples
and
grapes
for
export,
the
Agency
cannot
make
specific
recommendations
concerning
the
number
and
locations
of
the
foreign
field
trials
to
be
conducted.
In
general,
trials
must
be
conducted
in
all
countries
in
which
dinocap
is
sold
or
intended
to
be
sold.
All
countries
which
represent
at
least
5%
of
the
U.
S.
imports,
and
all
major
growing
areas
within
each
country
should
be
represented.
Substitution
of
data
from
one
country
to
another
is
acceptable
if
the
registrant
can
demonstrate
similar
climatic
conditions
and
cultural
practices.
The
Agency
is
in
the
process
of
developing
guidance
on
the
conduct
of
crop
field
trials
to
support
import
tolerances.
It
is
recommended
that
the
registrant
submit
a
protocol
before
generating
field
trial
data
for
these
commodities.

GLN
860.1520:
Processed
Food/
Feed
The
reregistration
requirements
for
magnitude
of
the
residue
in/
on
imported
apples
and
grapes
have
not
been
addressed.
The
Agency
has
determined
that
processing
studies
must
be
conducted
to
support
import
tolerances
if
the
imported
commodities
are
likely
to
be
processed
once
they
have
been
imported
into
the
U.
S.
or
if
processed
commodities
are
imported
into
the
U.
S.;
therefore,
the
registrant
must
conduct
processing
studies
on
apples
and
grapes.
In
the
required
processing
studies,
the
raw
agricultural
commodity
(
RAC)
should
be
processed
in
a
manner
simulating
typical
commercial
practice.
The
RAC
should
have
detectable
residues
so
that
a
concentration
factor
may
be
calculated.
Exaggerated
rates
and/
or
reduced
preharvest
intervals
may
be
necessary
to
ensure
that
the
RAC
to
be
processed
contains
sufficient
residues.
The
registrant
is
advised
to
consult
the
Agency
if
they
believe
processing
studies
are
not
necessary
for
imported
apples
or
grapes.
5
GLN
860.1480:
Meat,
Milk,
Poultry,
Eggs
The
requirement
for
a
ruminant
feeding
study
is
reserved
pending
submission/
review
of
the
requested
ruminant
metabolism
study
and
determination
of
terminal
residues
of
concern.
A
poultry
feeding
study
is
not
required
because
there
are
no
poultry
feed
items
derived
from
the
imported
crops
for
which
dinocap
uses
are
being
supported.

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

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

GLN
860.1850
and
860.1900:
Confined/
Field
Accumulation
in
Rotational
Crops
Residue
data
concerning
these
guideline
topics
are
not
required
because
apples
and
grapes
are
not
rotatable
crops.
In
addition,
rotational
crop
studies
are
not
required
for
import
tolerances
because
of
enforcement
issues.
(
continued;
footnotes
follow)
6
Table
A.
Residue
Chemistry
Science
Assessments
for
Reregistration
of
Dinocap.

GLN:
Data
Requirements
Current
Tolerances,
ppm
[
40
CFR]
Must
Additional
Data
Be
Submitted?
References
860.1200:
Directions
for
Use
N/
A
=
Not
Applicable
Yes
1
REFS
database
860.1300:
Plant
Metabolism
N/
A
Yes
2
PP#
9F0847
860.1300:
Animal
Metabolism
N/
A
Yes
3
860.1340:
Residue
Analytical
Methods
­
Plant
commodities
N/
A
Reserved
4
PAM
Volume
II
­
Animal
commodities
N/
A
Reserved
5
860.1360:
Multiresidue
Methods
N/
A
Reserved
6
PAM
Volume
I
860.1380:
Storage
Stability
Data
­
Plant
commodities
N/
A
Yes
7
­
Animal
commodities
N/
A
Reserved
8
860.1500:
Crop
Field
Trials
Pome
Fruits
Group
­
Apples
0.1
[
180.341(
a)]
Yes
9
Miscellaneous
Commodities
­
Grapes
0.1
[
180.341(
a)]
Yes
9
860.1520:
Processed
Food/
Feed
­
Apple
None
established
Yes
10
­
Grape
None
established
Yes
10
Table
A
(
continued).

GLN:
Data
Requirements
Current
Tolerances,
ppm
[
40
CFR]
Must
Additional
Data
Be
Submitted?
References
7
1.
The
registrant
must
submit
a
description
of
the
uses
of
dinocap
in
all
foreign
countries
in
which
dinocap
is
marketed
for
use
on
apples
and
grapes
that
may
be
exported
to
the
U.
S.
It
is
preferable
to
submit
copies
of
the
labels
(
which
have
been
translated
to
English).
The
information
must
include,
but
is
not
limited
to,
the
maximum
single
application
rate,
the
maximum
annual
application
rate,
application
timing
(
as
it
relates
to
the
plant
growth
stage),
retreatment
interval(
s),
application
tank­
mix
preparation,
volume
of
spray
mix
per
unit
area,
application
equipment,
and
the
pre­
harvest
interval
(
PHI).
Application
rates
should
be
expressed
in
units
of
pounds
of
active
ingredient
per
acre
(
or
kilograms
of
active
ingredient
per
hectare).

2.
The
registrant
must
submit
either
an
apple
or
a
grape
metabolism
study
to
determine
the
qualitative
metabolic
fate
of
dinocap
on
a
fruit
crop
when
it
has
been
applied
under
conditions
similar
to
the
foreign
uses.

3.
Because
wet
apple
pomace
is
a
livestock
feed
item,
the
registrant
must
submit
a
ruminant
metabolism
study
to
fulfill
reregistration
requirements.
If
Rohm
and
Haas
wishes
to
request
a
waiver
for
the
ruminant
metabolism
study,
they
must
convincingly
document
that
it
is
unlikely
that
imported
apples
or
wet
apple
pomace
would
be
significant
feed
items
in
the
U.
S.
or
exporting
countries
and/
or
that
there
are
not
significant
imports
of
livestock
commodities
from
the
exporting
countries
into
the
U.
S.

4.
A
single
analyte
method
is
available
in
PAM
Volume
II
for
the
enforcement
of
dinocap
tolerances,
as
currently
expressed.
This
method
must
be
revised
to
remove
the
use
of
benzene.
When
the
required
plant
metabolism
study
has
been
received,
and
the
residues
of
concern
have
been
determined,
the
Agency
may
require
new
plant
residue
analytical
method(
s)
for
the
purposes
of
data
collection
and
tolerance
enforcement.

5.
Enforcement
analytical
methods
are
not
available
for
dinocap
residues
in
animal
commodities.
The
requirement
for
animal
residue
analytical
method
is
reserved
pending
submission/
review
of
the
requested
ruminant
metabolism
study
and
determination
of
the
need
for
animal
tolerances.
860.1480:
Meat,
Milk,
Poultry,
Eggs
­
Milk,
Fat,
Meat,
and
Meat
Byproducts
of
Cattle,
Goats,
Hogs,
Horses,
and
Sheep
None
established
Reserved
11
­
Eggs
and
the
Fat,
Meat,
and
Meat
Byproducts
of
Poultry
None
established
No
860.1400:
Water,
Fish,
and
Irrigated
Crops
None
established
No
860.1460:
Food
Handling
None
established
No
860.1850:
Confined
Rotational
Crops
N/
A
No
860.1900:
Field
Rotational
Crops
None
established
No
Table
A
(
continued).

8
6.
A
multiresidue
method
is
available
in
PAM
Volume
I
for
the
determination
of
dinocap
residues.
The
Agency
may
require
additional
multiresidue
methods
data
when
the
required
plant
metabolism
study
has
been
received
and
the
residues
of
concern
have
been
determined.

7.
The
registrant
must
submit
data
pertaining
to
the
storage
stability
of
residues
of
the
parent
and
all
residues
of
regulatory
and/
or
risk
concern
in/
on
apples
and
grapes.
Storage
stability
studies
must
reflect
the
storage
conditions
and
intervals
of
samples
used
in
the
required
plant
metabolism
and
magnitude
of
the
residue
studies.
Storage
stability
data
are
not
needed
for
analytes
not
known
to
be
labile
or
volatile
if
samples
are
stored
for
less
than
4­
6
months
for
the
metabolism
study
30
days
for
magnitude
of
the
residue
studies.

8.
The
requirement
for
storage
stability
data
for
animal
commodities
is
reserved
pending
submission/
review
of
the
requested
ruminant
metabolism
study
and
determination
of
the
need
for
animal
tolerances.

9.
Field
residue
data
must
be
submitted
reflecting
the
maximum
use
patterns
for
representative
dinocap
formulations
on
apples
and
grapes
to
be
exported
to
the
U.
S.
Because
Rohm
and
Haas
has
not
provided
any
use
pattern
data
or
indicated
in
which
countries
dinocap
is
used
or
intended
to
be
used
on
apples
and
grapes
for
export,
the
Agency
cannot
make
specific
recommendations
concerning
the
number
and
locations
of
the
foreign
field
trials
to
be
conducted.
In
general,
trials
must
be
conducted
in
all
countries
in
which
dinocap
is
sold
or
intended
to
be
sold.
All
countries
which
represent
at
least
5%
of
the
U.
S.
imports,
and
all
major
growing
areas
within
each
country
should
be
represented.
Substitution
of
data
from
one
country
to
another
is
acceptable
if
the
registrant
can
demonstrate
similar
climatic
conditions
and
cultural
practices.
The
Agency
is
in
the
process
of
developing
guidance
on
the
conduct
of
crop
field
trials
to
support
import
tolerances.
It
is
recommended
that
the
registrant
submit
a
protocol
before
generating
field
trial
data
for
these
commodities.

10.
The
registrant
must
conduct
processing
studies
on
apples
and
grapes.
In
the
required
processing
studies,
the
raw
agricultural
commodity
(
RAC)
should
be
processed
in
a
manner
simulating
typical
commercial
practice.
The
RAC
should
have
detectable
residues
so
that
a
concentration
factor
may
be
calculated.
Exaggerated
rates
and/
or
reduced
preharvest
intervals
may
be
necessary
to
ensure
that
the
RAC
to
be
processed
contains
sufficient
residues.
The
registrant
is
advised
to
consult
the
Agency
if
they
believe
processing
studies
are
not
necessary
for
imported
apples
or
grapes.

11.
The
requirement
for
a
ruminant
feeding
study
is
reserved
pending
submission/
review
of
the
requested
ruminant
metabolism
study
and
determination
of
terminal
residues
of
concern.
9
TOLERANCE
REASSESSMENT
SUMMARY
Tolerances
for
residues
of
dinocap
in/
on
raw
agricultural
commodities
are
currently
expressed
in
terms
of
the
"
combined
negligible
residues
of
a
fungicide
and
insecticide
that
is
a
mixture
of
2,4­
dinitro­
6­
octylphenyl
crotonate
and
2,6­
dinitro­
4­
octylphenyl
crotonate"
[
40
CFR
§
180.341(
a)].
The
adequacy
of
the
tolerance
expression
will
be
reassessed
following
submission
and
evaluation
of
the
requested
fruit
metabolism
study.
The
HED
Metabolism
Assessment
Review
Committee
(
MARC)
may
be
consulted
to
determine
dinocap
residues
of
regulatory
and/
or
risk
concern.

Tolerances
Listed
Under
40
CFR
§
180.341(
a):

Tolerances
of
0.1
ppm
have
been
established
for
apples
and
grapes;
see
Table
B
below.
The
adequacy
of
these
RAC
tolerances,
as
import
tolerances,
cannot
be
determined
at
this
time
because
additional
residue
data
from
foreign
field
trials
are
required.
Processing
data
on
apples
and
grapes
are
also
required.
If
the
requested
processing
data
indicate
that
dinocap
residues
of
concern
concentrate
in
the
processed
fractions
of
apples
and
grapes
imported
into
the
U.
S.,
then
the
registrant
will
be
required
to
propose
tolerances.

Table
B.
Tolerance
Reassessment
Summary
for
Dinocap.

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

Tolerances
Established
Under
40
CFR
§
180.341(
a)

Apples
0.1
To
be
determined.
[
Apple]

Grapes
0.1
To
be
determined.
[
Grape]

CODEX
HARMONIZATION
There
are
currently
no
Codex
MRLs
established
for
residues
of
dinocap.
JMPR
has
recommended
MRLs
of
0.2
ppm
for
apples
and
1
ppm
for
grapes
based
on
residues
in
European
trials
which
showed
<
0.05
(
ND)­
0.09
ppm
in
apples
and
<
0.05­
0.67
ppm
in
grapes;
in
1998.
These
values
have
not
been
adopted
because
of
acute
dietary
risk
concerns.
The
issue
is
to
be
addressed
in
2002.
The
Codex
MRLs
are
expressed
in
terms
of
dinocap
isomers
and
phenols,
expressed
as
dinocap.
Current
U.
S.
tolerances
are
0.1
ppm
(
negligible)
for
both
apples
and
grapes
(
40
CFR
180.341).
Harmonization
of
the
tolerance
expression/
definition
and
tolerances
between
Codex
MRLs
and
U.
S.
tolerances
can
not
be
achieved
until
outstanding
metabolism
and
residue
data
are
submitted.
10
AGENCY
MEMORANDA
RELEVANT
TO
REREGISTRATION
DP
Barcode:
None
Subject:
PP#
9F0847:
Karathane
on
various
commodities.
Evaluation
of
analytical
method
and
residue
data.
From:
E.
Gunderson
To:
Petition
Evaluation
Branch,
Division
of
Pesticides
Dated:
9/
15/
69
MRID(
s):
N/
A.

DP
Barcode:
None
Subject:
Request
for
the
establishment
of
tolerances
of
0.05
ppm
for
negligible
residues
of
the
fungicide­
miticide
Karathane
in
or
on
cucurbits,
pome
fruits,
stone
fruits,
and
strawberries.
From:
J.
Svirbely
To:
D.
Baker
Dated:
8/
17/
72
MRID(
s):
N/
A.

DP
Barcode:
D178967
Subject:
Dinocap.
Case
No.
2200.
Request
for
waiver
of
data
requirements.
From:
F.
Fort
To:
S.
Rathman/
B.
Briscoe
Dated:
7/
14/
92
MRID(
s):
None
DP
Barcode:
D198079
Subject:
Dinocap.
Data
Required
to
Support
Tolerances
with
Canceled
U.
S.
Registrations
as
Import
Tolerances.
From:
M.
Metzger
To:
S.
Rathman
and
R.
Kumar
Dated:
2/
24/
94
MRID(
s):
None