UNITED
STATES
ENVIRONMENTAL
PROTECTION
AGENCY
WASHINGTON,
D.
C.
20460
OFFICE
OF
PREVENTION,
PESTICIDES
AND
TOXIC
SUBSTANCES
MEMORANDUM
Date:
4/
30/
04
Subject:
Amitraz.
TRED
­
Report
on
FQPA
Tolerance
Reassessment
Progress
and
Interim
Risk
Management
Decisions.
Residue
Chemistry
Considerations.
Case
No.
0234.

DP
Barcode:
D300301
PC
Code:
106201
40
CFR:
§
180.287
From:
José
J.
Morales,
Chemist
Reregistration
Branch
3
Health
Effects
Division
(
7509C)

Through:
Danette
Drew,
Branch
Senior
Scientist
Reregistration
Branch
3
Health
Effects
Division
(
7509C)

To:
John
Pates,
Chemical
Review
Manager
Reregistration
Branch
1
Special
Review
and
Reregistration
Division
(
7508C)
Amitraz
Residue
Chemistry
Considerations
­
TRED
Barcode:
D300301
2
Executive
Summary
Amitraz
[
N'­(
2,4­
dimethylphenyl)­
N­[[(
2,4­
dimethylphenyl)
imino]
methyl]­
Nmethylmethanimidamide
is
an
insecticide/
acaricide
with
registered
food/
feed
uses
in
the
U.
S.
on
cotton,
pears,
beef
and
dairy
cattle,
and
hogs.
Amitraz
is
currently
registered
for
use
on
cotton
to
control
various
insects
(
bollworm
larvae
and
eggs,
beet
armyworm,
whitefly,
aphids,
and
spider
mites)
as
well
as
on
pears
for
the
control
of
pear
psylla
and
grape
mealybug.
Amitraz
can
be
applied
by
airblast
and
concentrate
spray
(
pears)
with
up
to
3.0
lb
a.
i./
acre
applied
during
dormancy
and
throughout
the
growing
season
excluding
prebloom
applications.
It
can
also
be
applied
via
ground
boom
or
aircraft
(
cotton)
with
up
to
1.0
lb
a.
i./
acre
during
the
growing
season
with
a
maximum
of
eight
applications
per
year.
Current
formulations
include:
wettable
powder,
emulsifiable
concentrate,
and
soluble
concentrate/
liquid.
In
addition,
an
import
tolerance
has
been
established
to
support
amitraz
use
on
hops
to
be
imported
into
the
U.
S.
Amitraz
products
with
food/
feed
uses
are
registered
in
the
U.
S.
to
Bayer
CropScience
(
BCS)
LP
and
Intervet,
Inc.
under
the
trade
names
Ovasyn
®
,
Mitac
®
,
and
Taktic
®
.
Currently,
the
1.5
lb/
gal
soluble
concentrate
(
SC),
50%
wettable
powder
(
WP),
and
12.5%
emulsifiable
concentrate
(
EC)
formulations
are
registered
for
use
on
food/
feed
sites.
The
SC
formulation
is
registered
for
use
on
cotton,
and
the
WP
formulation
is
registered
for
use
on
pears.
The
EC
formulation
is
registered
for
use
on
cattle
and
swine
as
dermal
treatments.

Amitraz
is
also
used
for
tick
control
on
dogs
as
well
as
mite
and
lice
management
on
beef
cattle,
dairy
cattle
and
swine.
In
the
case
of
tick
and
flea
collars
(
Preventic
®
and
Preventic
®
Plus),
application
should
be
made
every
three
months
in
dogs
more
than
12
weeks
of
age.
Additionally,
amitraz
can
be
applied
via
dip
or
low
pressure
hand
spray
for
cattle
and
swine
with
up
to
0.2
lb
a.
i./
50
gallons
of
water.
For
the
use
of
Taktic
E.
C.
on
beef
cattle,
dairy
cattle
and
swine,
the
following
application
methods
are
suggested:
1)
cattle
applied
via
spraying
or
by
a
spray
dip
machine,
2)
swine
applied
via
spraying,
and
3)
piglets/
weaners
applied
by
dipping.
However,
Taktic
E.
C.
is
not
to
be
applied
within
three
days
of
slaughter
for
swine,
which
are
not
to
be
treated
more
than
four
times
per
year.
All
of
the
established
tolerances
for
meats,
meat
byproducts
and
milk
will
be
maintained
to
support
the
animal
health
uses.

In
a
recent
letter
to
the
Agency,
BCS
has
decided
to
voluntarily
withdraw
the
registrations
of
Ovaysn
Insecticide/
Miticide
(
EPA
Reg.
No.
264­
625)
and
Mitac
W
Insecticide
(
EPA
Reg.
No.
264­
636).
The
registrant
has
also
requested
to
maintain
the
registration
of
technical
amitraz,
to
revoke
established
tolerances
for
apples,
beeswax,
honey,
and
pears
as
well
as
maintain
import
tolerances
for
hops
and
cottonseed
(
Amitraz
Use
Closure
Memo,
10/
22/
03).
Amitraz
Residue
Chemistry
Considerations
­
TRED
Barcode:
D300301
3
Amitraz
is
a
FIFRA
List
A
pesticide
assigned
to
Case
No.
0234
and
was
the
subject
of
a
Reregistration
Standard
Guidance
Document
dated
10/
87.
The
Residue
Chemistry
Chapter
of
the
Amitraz
Reregistration
Standard
Update
was
issued
7/
6/
90.
The
Residue
Chemistry
Chapter
for
the
Amitraz
Reregistration
Eligibility
Decision
document
(
RED)
was
issued
9/
17/
93,
and
the
Amitraz
RED
was
signed
03/
95.
The
information
contained
in
this
document
outlines
the
Residue
Chemistry
Science
Assessments
with
respect
to
the
reassessment
of
tolerances
for
amitraz
residues
of
concern.

The
qualitative
nature
of
the
residue
in
plants
and
animals
is
adequately
understood
based
on
plant
metabolism
studies
with
apples,
beans,
lemons,
citrus,
cotton,
and
pears,
and
animal
metabolism
studies
with
cattle
and
swine
(
dermal
application)
and
cattle,
goats
and
hens
(
oral
dosing).

Tolerances
have
been
established
under
40
CFR
§
180.287
for
the
combined
residues
of
amitraz
and
its
two
metabolites,
N­(
2,4­
dimethylphenyl)
formamide
and
N­(
2,4­
dimethylphenyl)­
Nmethylmethanimidamide
both
calculated
as
the
parent
compound
in/
on
cotton,
undelinted
seed,
at
1
ppm,
honey
at
1
ppm,
honeycomb
at
6
ppm,
dried
hop
cones
at
60
ppm,
pear
at
3
ppm,
and
in
animal
commodities
at
levels
ranging
from
0.01
to
0.3
ppm.

Adequate
tolerance
enforcement
methods
are
listed
in
PAM
Volume
II
for
the
determination
of
amitraz
residues
of
concern
in
plant
and
animal
commodities.

Residue
Chemistry
Deficiencies
Provided
that
the
registered
uses
on
cotton
and
pears
are
cancelled,
there
are
no
residue
chemistry
deficiencies
pertaining
to
amitraz
reregistration.

The
registrant
has
indicated
that
they
would
like
to
keep
the
cotton
tolerance
as
an
import
tolerance.
HED
notes
that
there
is
a
Codex
MRL
for
cottonseed.
If
a
Codex
MRL
has
been
established,
the
NAFTA
countries
may
conduct
a
more
limited
review
of
the
residue
chemistry
data
under
certain
conditions.
The
NAFTA
countries
are
more
likely
to
adopt
MRLs
similar
to
Codex
MRL
levels
if
MRLs
for
the
pesticide
are
already
established
on
other
commodities
with
a
contemporary
robust
database.
Standard
data
and
review
requirements
would
be
applied
where
exposure
and/
or
risk
to
any
subpopulation
from
the
pesticide
is
high.
An
EPA­
specific
detailed
description
of
how
the
U.
S.
may
consider
Codex
MRLs
as
they
relate
to
data
requirements
can
be
found
in
Unit
VIII
of
the
U.
S.
Import
Tolerances
Guidance
document
(
65
FR
35069).
The
registrant
needs
to
submit
a
formal
request
to
the
Agency
for
establishment
of
the
cottonseed
tolerance
as
an
import
tolerance,
and
information
about
the
use
pattern
in
foreign
countries,
and
residue
data
from
those
countries
to
support
the
request.
Amitraz
Residue
Chemistry
Considerations
­
TRED
Barcode:
D300301
4
N
N
N
C
H
3
CH
3
C
H
3
CH
3
CH
3
Background
The
PC
Code
and
nomenclature
of
amitraz
are
listed
below
in
Table
1.
The
physicochemical
properties
of
amitraz
are
listed
in
Table
2.
The
chemical
names
and
structures
of
amitraz
residues
of
concern
are
presented
in
Table
3.

Table
1.
Amitraz
Nomenclature
Chemical
structure
Common
name
Amitraz
Molecular
Formula
C19H23N3
Molecular
Weight
293.42
IUPAC
name
N­
methylbis(
2,4­
xylyliminomethyl)
amine
CAS
name
N'­(
2,4­
dimethylphenyl)­
N­[[(
2,4­
dimethylphenyl)
imino]
methyl]­
Nmethylmethanimidamide
CAS
#
33089­
61­
1
PC
Code
106201
Current
Food/
Feed
Site
Registration
Cotton,
pear,
beef
and
dairy
cattle,
hog,
goats,
horses,
sheep
Table
2.
Physicochemical
Properties
of
Amitraz.

Parameter
Value
Reference
Melting
point/
range
86­
87

C
Amitraz
RED,
03/
95
pH
of
1%
aqueous
suspension
N/
A
(
low
solubility;
decomposes
in
water)
Amitraz
RED,
03/
95
Density
or
specific
gravity
1.128
g/
mL
at
20

C
Amitraz
RED,
03/
95
Water
solubility
<
1
ppm
at
20­
25

C
Amitraz
RED,
03/
95
Solvent
solubility
At
20­
25

C
xylene
66.6
g/
100
mL
acetone
50.0
g/
100
mL
methanol
2.38
g/
100
mL
Amitraz
RED,
03/
95
Vapor
pressure
3.4
x
10­
4
Pa
at
25

C
Amitraz
RED,
03/
95
Octanol/
water
partition
coefficient
(
Kow)
3.0
x
105
at
25

C
(
pH
5.8)
CBRS
No.
3975,
7/
21/
88,
H.
Fonouni.
Amitraz
Residue
Chemistry
Considerations
­
TRED
Barcode:
D300301
5
N
N
N
C
H
3
CH
3
C
H
3
CH
3
CH
3
NH
O
H
C
H
3
CH
3
N
NH
C
H
3
CH
3
CH
3
Table
3.
Chemical
Names
and
Structures
of
Amitraz
and
its
Residues
of
Concern.

Company
Name
Chemical
Name
Structure
Amitraz
N'­[
2,4­
dimethylphenyl]­
N­[[(
2,4­
dimethylphenyl)
imino]
methyl]]­
Nmethyl
methanimidamide
BTS­
27919
N­(
2,4­
dimethylphenyl)
formamide
BTS­
27271
N­(
2,4­
dimethylphenyl)­
Nmethylmethanimidamide
RESIDUE
CHARACTERIZATION
General
Discussion
on
Residue
Chemistry
of
Amitraz
860.1200
Directions
for
Use
Product
List
A
6/
9/
03
product
registration
query
of
the
Agency's
OPPIN
database
identified
three
amitraz
end­
use
products
(
EPs)
registered
for
use
on
food/
feed
sites.
These
EPs
are
listed
in
Table
4
below.
There
are
no
SLN
registrations
associated
with
amitraz.

At
the
time
of
the
9/
93
RED
Chapter,
there
were
six
registered
EPs
with
food/
feed
uses:
the
Nor­
Am
Chemical
Company
50%
WP
(
EPA
Reg.
No.
45639­
61),
1.5
lb/
gal
EC
(
EPA
Reg.
No.
45639­
49),
and
1.5
lb/
gal
SC
(
EPA
Reg.
No.
45639­
146),
and
the
Hoechst­
Roussel
Agri­
Vet
Company
12.5%
EC
(
EPA
Reg.
No.
54382­
3)
and
10%
Impr
(
EPA
Reg.
Nos.
54382­
4
and
54382­
5).
The
Nor­
Am
1.5
lb/
gal
SC
has
since
been
transferred
to
Bayer
CropScience,
the
Hoechst
12.5%
EC
is
currently
registered
to
Intervet
Inc.,
and
the
remaining
EPs
have
been
canceled.
Amitraz
Residue
Chemistry
Considerations
­
TRED
Barcode:
D300301
6
Table
4.
Amitraz
End­
Use
Products
(
EPs)
with
Food/
Feed
Uses.

EPA
Reg.
No.
Formulation
Registrant
Product
Name
264­
625
1.5
lb/
gal
SC
Bayer
CropScience
Ovasyn
®
Insecticide/
Miticide;
An
Organophosphate
Insecticide
for
Use
on
Cotton
264­
636
50%
WP
Bayer
CropScience
Mitac
®
W
Insecticide
For
Pears
54382­
3
12.5%
EC
Intervet
Inc.
Taktic
®
Emulsifiable
Concentrate
Miticide/
Insecticide
Use
Patterns
A
tabular
summary
of
the
residue
chemistry
science
assessments
for
reregistration
of
amitraz
is
presented
in
Table
5.
The
conclusions
listed
in
Table
5
regarding
the
reregistration
eligibility
of
amitraz
food/
feed
uses
are
based
on
the
use
patterns
to
be
supported
by
the
data
submitters,
Bayer
CropScience
and
Intervet,
Inc.
When
end­
use
product
DCIs
are
developed,
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
producers'
labels.

We
note
that
since
the
9/
93
RED
Chapter,
the
uses
in
beehives
have
been
cancelled.
In
addition,
Bayer
CropScience
has
stated
that
they
will
be
requesting
cancellation
of
use
of
amitraz
on
cotton
and
pears.

860.1300
Nature
of
the
Residue
­
Plants
The
qualitative
nature
of
the
residue
in
plants
is
adequately
understood.
Acceptable
plant
metabolism
studies
have
been
submitted
for
apples,
beans,
lemons,
citrus,
cotton,
and
pears,
and
were
reviewed
either
in
the
10/
15/
84
Residue
Chemistry
Science
Chapter
of
the
Registration
Standard
or
the
7/
6/
90
Reregistration
Standard
Update.
The
terminal
residues
of
concern
are
amitraz
and
its
metabolites
containing
the
2,4­
dimethylaniline
(
2,4­
DMA)
moiety
(
BTS­
27919
and
BTS­
27271);
these
are
the
residues
which
are
presently
included
in
the
tolerance
expression.
The
HED
Metabolism
Committee,
in
its
7/
15/
92
deliberations
concerning
the
toxicological
significance
of
2,4­
DMA
per
se,
has
determined
that
this
metabolite
does
not
require
separate
regulation
and/
or
quantitation
of
residues,
concluding
that
there
is
no
need
to
require
residue
data
for
2,4­
DMA
because
the
current
analytical
enforcement
methods
detect
all
residues
containing
the
2,4­
DMA
moiety.

The
HED
Chem
SAC
(
3/
31/
04
meeting)
has
recommended
that
the
current
tolerance
expression
for
amitraz
needs
to
be
changed
by
removing
the
reference
to
specific
metabolites.
The
tolerance
expression
should
specify
that
the
terminal
residues
of
concern
for
enforcement
purposes
are
amitraz
and
its
metabolites
containing
the
2,4­
dimethylaniline
moiety.
Amitraz
Residue
Chemistry
Considerations
­
TRED
Barcode:
D300301
7
860.1300
Nature
of
the
Residue
­
Livestock
Because
the
registrant
intends
to
cancel
use
of
amitraz
on
cotton,
data
pertaining
to
the
qualitative
nature
of
the
residue
in
poultry
and
ruminants
following
oral
dosing
is
not
required.

The
qualitative
nature
of
the
residue
in
livestock
following
dermal
application
is
adequately
understood.
The
terminal
residues
of
concern
are
amitraz
and
its
metabolites
containing
the
2,4­
dimethylaniline
(
2,4­
DMA)
moiety
(
BTS­
27919
and
BTS­
27271);
these
are
the
residues
which
are
presently
included
in
the
tolerance
expression
(
HED
Metabolism
Committee
review
of
7/
20/
92).

The
HED
Chem
SAC
(
3/
31/
04
meeting)
has
recommended
that
the
current
tolerance
expression
for
amitraz
needs
to
be
changed
by
removing
the
reference
to
specific
metabolites.
The
tolerance
expression
should
specify
that
the
terminal
residues
of
concern
for
enforcement
purposes
are
amitraz
and
its
metabolites
containing
the
2,4­
dimethylaniline
moiety.

860.1340
Residue
Analytical
Methods
Enforcement
methods:
There
are
two
adequate
methods
listed
in
FDA's
Pesticide
Analytical
Manual
(
PAM
Vol.
II)
for
purposes
of
data
collection
and
enforcement
of
tolerances
for
residues
of
amitraz
and
its
metabolites
containing
the
2,4­
dimethylaniline
moiety.
Methods
I
(
designed
for
animal
tissues
and
milk)
and
II
(
designed
for
plant
commodities)
are
both
GLC
methods
with
electron
capture
detection
(
ECD),
and
involve
conversion
of
residues
of
amitraz
and
its
metabolites
containing
the
2,4­
dimethylaniline
moiety
to
2,4­
DMA
using
acid
and
base
hydrolysis,
respectively.
The
detection
limits
of
the
methods
are
0.01
ppm
for
milk
and
0.05
ppm
for
plant
commodities
and
animal
tissues.

The
enforcement
methods
have
not
been
radiovalidated;
however,
the
data
collection
method
for
plant
commodities
(
similar
to
Method
II)
was
successfully
radiovalidated
using
samples
from
the
pear
metabolism
study.
Because
the
extraction
procedure
is
extensive
(
hydrolysis
with
acid
at
reflux),
the
Agency
will
not
require
radiovalidation
data
for
the
enforcement
method
for
animal
commodities.

Data
collection
methods:
A
GC/
ECD
method
was
used
for
the
determination
of
amitraz
residues
of
concern
in
hops.
A
brief
description
of
this
method
follows.

Samples
were
hydrolyzed
with
2N
HCl
at
reflux
for
3
hours
to
liberate
amitraz
and
its
metabolites
from
conjugates.
The
hydrolysate
was
basified
with
sodium
hydroxide,
and
the
mixture
was
refluxed
for
1.5
hours
to
convert
amitraz
and
metabolites
to
2,4­
dimethylaniline,
which
was
isolated
by
steam
distillation
and
then
partitioned
into
hexane.
Residues
were
cleaned
up
by
aqueous/
solvent
partition
and
then
derivatized
with
heptafluorobutyric
anhydride
for
GC/
ECD
analysis.
The
limit
of
quantitation
was
0.05
ppm
for
dried
hops.
Amitraz
Residue
Chemistry
Considerations
­
TRED
Barcode:
D300301
8
This
method
differs
from
the
enforcement
method
for
plant
commodities
in
that
residues
are
extracted/
hydrolyzed
using
acid
and
then
basified
to
convert
to
2,4­
dimethylaniline;
2,4­
dimethylaniline
residues
are
then
distilled
into
hexane.
In
Method
II
of
PAM
Vol.
II,
base
hydrolysis
is
used
to
extract
residues
and
convert
them
to
2,4­
dimethylaniline;
these
residues
are
then
partitioned
into
isooctane.
HED
has
recommended
that
this
method
be
forwarded
to
FDA
for
publication
in
PAM
Vol.
II
as
Method
A.

Amitraz
residues
of
concern
in
animal
commodities
were
determined
using
a
GC/
ECD
method
similar
to
the
method
used
for
hops.

860.1360
Multiresidue
Methods
The
FDA
PESTDATA
database
dated
11/
01
(
PAM
Volume
I,
Appendix
I)
indicates
that
amitraz
has
small
recovery
(<
50%)
using
Multiresidue
Method
Section
302
(
Luke
Method;
Protocol
D)
and
that
metabolite
BTS­
27919
is
completely
recovered
using
Section
302.
The
database
contains
no
information
on
the
recovery
of
amitraz
or
its
metabolites
using
Multiresidue
Method
Sections
303
(
Mills,
Onley,
and
Gaither
Method;
Protocol
E,
nonfatty
food)
and
304
(
Mills
Method;
Protocol
E,
fatty
food).

860.1380
Storage
Stability
Adequate
data
are
available
to
support
the
existing
crop
field
trial
and
feeding
studies.

Storage
stability
studies
have
been
conducted
using
fortified
samples
of
citrus
fruits,
cow
tissues
and
milk,
and
cottonseed.
Residues
of
amitraz
are
stable
in
cottonseed
for
13.5
months
of
frozen
storage,
and
residues
of
BTS­
27271
and
BTS­
27919
are
stable
in/
on
citrus
fruits
stored
frozen
(­
20

C)
for
up
to
18
months;
these
data
may
be
translated
to
hops.
Residues
of
amitraz,
BTS­
27271,
and
BTS­
27919
are
stable
in
cow
tissues
and
milk
stored
frozen
(­
20

C)
for
up
to
12­
15
months,
and
in
hog
muscle
and
fat
stored
frozen
(

­
15

C)
for
at
least
12
months.
The
storage
intervals
and
conditions
from
the
magnitude
of
the
residue
studies
in
plants
and
animals
are
adequately
supported
by
storage
stability
data.

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

860.1460
Food
Handling
Amitraz
is
not
presently
registered
for
use
in
food­
handling
establishments;
therefore,
no
residue
chemistry
data
are
required
under
this
guideline
topic.
Amitraz
Residue
Chemistry
Considerations
­
TRED
Barcode:
D300301
9
860.1480
Meat,
Milk,
Poultry,
and
Eggs
Currently,
there
are
registered
direct
animal
treatments
of
amitraz
to
beef
and
dairy
cattle
and
hogs.
The
only
registered
amitraz
use
with
associated
livestock
feed
items
is
cotton,
which
the
registrants
do
not
intend
to
support.
An
HED
document
dated
4/
21/
04
estated
the
following:
At
an
OECD
guidelines
harmonization
meeting
(
March
16
to
18,
2004),
the
Croplife
International
representative
from
Europe
stated
that
cotton
gin
byproducts
or
cotton
gin
trash
are
not
allowed
to
be
fed
to
livestock
in
Europe.
Therefore,
imported
meat
is
not
an
issue
with
respect
to
amitraz
secondary
residues
by
feeding
cotton
gin
trash.
The
imported
cottonseed
items
from
Australia
are
undelinted
cottonseed.
According
to
the
U.
S.
Department
of
Census
Bureau,
Foreign
Trade
Statistics
approximately
320,
959
MT
of
cottonseed
from
Australia
was
imported
in
to
the
U.
S.
in
2001,
and
264,
627
MT
in
2002.
In
comparison
the
US
produces
cotton
on
5.17
million
hectare
and
produces
18.6
million
480
lb
bales,
and
over
6,000,000
MT
of
cottonseed,
while
Australia
on
0.19
million
hectares
and
produces
0.34
million
480
lb
bales.
The
imported
cottonseed
from
Australia
is
used
by
California
dairy
industry
as
part
of
their
diet,
and
is
fed
as
cottonseed
only.
Some
is
planted
as
seed
cotton.
The
Californian
dairy
industry
is
run
like
a
cattle
feedlot,
unlike
other
areas
of
the
country
where
they
are
allowed
to
pasture.
Only
7­
9
lb
cottonseed/
cow
can
be
fed
each
day.
Therefore,
even
in
this
cottonseed
is
fed
to
animals,
the
contribution
to
the
diet
will
be
insignificant
when
compared
with
the
contribution
from
the
dermal
applications.

Currently,
amitraz
may
be
applied
twice
to
beef
and
dairy
cattle
as
a
0.05%
ai
spray,
with
a
7­
day
retreatment
interval
and
no
pre­
slaughter
interval
(
PSI).
Hogs
may
be
treated
four
times
per
year
with
a
solution
containing
0.36
lb
ai/
100
gal,
or
0.05%.
A
3­
day
PSI
has
been
established.
Although
an
acceptable
dairy
cattle
feeding
study
has
been
submitted,
the
only
magnitude
of
the
residue
data
relevant
to
the
current
use
pattern
are
dermal
application
data.

Data
have
been
submitted
reflecting
total
amitraz
residues
(
residues
of
amitraz
and
its
metabolites
convertible
to
2,4­
dimethylaniline)
in
cattle
matrices
following
dermal
treatment.
Cattle
were
treated
twice
with
either
a
0.05%
or
0.15%
ai
spray
solution
with
a
7­
day
retreatment
interval
and
then
sacrificed
at
pre­
slaughter
intervals
of
1,
3,
7,
and
14
days.
The
results
of
this
study
are
presented
below.
Amitraz
Residue
Chemistry
Considerations
­
TRED
Barcode:
D300301
10
Pre­
slaughter
Interval
(
days)
%
ai
in
Spray
Maximum
Total
Amitraz
Residues
(
ppm)
in
Cattle
Muscle
Liver
Kidney
Fat
1
0.05
(
2
applications)
0.02
0.09
0.13
0.04
3
0.01
0.08
0.08
0.07
7
<
0.01
0.04
0.02
0.02
14
<
0.01
0.02
0.01
0.01
1
0.15
(
2
applications)
0.05
0.24
0.31
0.09
3
0.02
0.15
0.21
0.09
7
<
0.01
0.07
0.07
0.04
14
<
0.01
0.03
0.01
0.02
In
addition,
in
a
study
in
which
lactating
dairy
cattle
were
treated
with
two
sprays
containing
0.025%
(
0.5X),
0.05%
(
1X),
or
0.10%
(
2X)
amitraz,
with
a
10­
day
retreatment
interval,
total
amitraz
residues
in
milk
were
0.003­
0.013
ppm,
0.006­
0.025
ppm,
and
0.012­
0.038
ppm,
respectively.
Residues
were
found
to
concentrate
5x
in
butterfat.

Data
have
been
submitted
reflecting
total
amitraz
residues
in
hog
matrices
following
dermal
treatment.
Hogs
were
sprayed
to
runoff
with
a
solution
containing
0.1%
amitraz.
Two
applications
were
made
seven
days
apart,
and
the
hogs
were
slaughtered
one
day
following
the
second
treatment.
Maximum
combined
residues
of
amitraz
and
its
metabolites
containing
the
2,4­
dimethylaniline
moiety
were
<
0.05
ppm
in
muscle,
0.06
ppm
in
fat,
0.05
ppm
in
liver,
and
0.07
ppm
in
kidney.

A
second
hog
study
reflecting
dermal
application
was
conducted
in
which
hogs
were
treated
with
a
solution
of
2
oz
(
0.05%
amitraz)
or
4
oz
(
0.10
%
amitraz)
of
product
(
Taktic
E.
C.)
in
3
gal
of
water.
A
second
application
was
made
seven
days
after
the
first,
and
hogs
were
slaughtered
1,
3,
7,
and
14
days
following
treatment.
Maximum
combined
residues
of
amitraz
and
its
metabolites
containing
the
2,4­
dimethylaniline
moiety
were
0.006
ppm
in
muscle,
0.017
ppm
in
fat,
0.038
ppm
in
liver,
and
0.039
ppm
in
kidney
from
hogs
slaughtered
3
days
following
treatments
at
2
oz
product/
3
gal
(
approximately
1x).

A
hog
skin
processing
study
has
also
been
submitted.
The
results
of
this
study
indicated
that
residues
in
hog
skin
and
puffed
rind
exceeded
0.2
ppm
and
that
a
0.3­
ppm
tolerance
was
appropriate
for
hog
meat
byproducts.
Amitraz
Residue
Chemistry
Considerations
­
TRED
Barcode:
D300301
11
860.1500
Crop
Field
Trials
The
9/
93
RED
Chapter
concluded
that
the
reregistration
data
requirements
for
magnitude
of
the
residue
in
plants
were
fulfilled
for
the
food/
feed
crops
registered
at
that
time,
cotton
and
pears.
It
was
also
concluded
that
reregistration
data
requirements
pertaining
to
magnitude
of
the
residue
were
fulfilled
for
honey.
Since
the
9/
93
RED
Chapter,
all
uses
of
amitraz
in
beehives
have
been
cancelled,
and
the
registrant
has
stated
that
they
intend
to
cancel
uses
of
amitraz
on
cotton
and
pears.
Therefore,
no
additional
data
pertaining
to
the
magnitude
of
the
residue
are
required
for
cotton,
pears,
honey,
or
honey
comb.

An
import
tolerance
petition
for
dried
hops
was
pending
at
the
time
of
the
9/
93
RED
Chapter.
This
tolerance
has
since
been
established.
Reregistration
requirements
pertaining
to
magnitude
of
the
residue
in
plants
are
fulfilled
for
dried
hops.
At
the
time
of
the
petition
request,
amitraz
was
registered
for
use
on
hops
in
the
UK
at
2
lb
ai/
A
with
a
49­
day
PHI,
and
in
Germany
and
Czechoslovakia
at
2.14
lb
ai/
A
with
a
21­
day
PHI.
In
trials
conducted
in
Germany,
Czechoslovakia,
and
the
UK,
combined
residues
of
amitraz
and
its
metabolites
convertible
to
2,4­
dimethylaniline
were
1.3­
45
ppm
in
dried
hops
harvested
28
days
following
the
last
of
two
applications
of
a
20%
EC
formulation
at
a
total
rate
of
3.2­
3.77
lb
ai/
A
(

1.5­
2x).
Combined
residues
were
12.6­
58.6
ppm
in/
on
dried
hops
harvested
20­
22
days
following
two
applications
of
a
20%
EC
formulation
at
1.11­
1.34
lb
ai/
A/
application
(
1­
1.3x)
in
Germany,
and
were
26­
42
ppm
in/
on
dried
hops
harvested
28­
35
days
following
two
applications
at
1.6
and
1.78
lb
ai/
A
(
total
rate
of
3.38
lb
ai/
A;
1.6x)
in
Germany.

860.1520
Processed
Food
and
Feed
The
9/
93
RED
Chapter
concluded
that
the
reregistration
data
requirements
pertaining
to
magnitude
of
the
residues
in
processed
food/
feed
were
fulfilled.
Adequate
cotton
processing
studies
indicate
that
amitraz
residues
of
concern
do
not
concentrate
in
the
hulls,
meal,
crude
oil,
refined
oil,
and
soapstock
processed
from
cottonseed
following
application
at
exaggerated
rates.

860.1850
and
860.1900
Confined
and
Field
Accumulation
in
Rotational
Crops
The
9/
93
RED
Chapter
concluded
that
additional
data
were
required
to
upgrade
the
available
confined
rotational
crop
study
to
allow
a
conclusion
to
be
made
regarding
the
magnitude
of
residues
in
rotational
crops.
These
data
were
considered
confirmatory
for
the
purposes
of
reregistration.
The
RED
Chapter
also
noted
that
field
rotational
crop
studies
had
been
reviewed
by
EFED
and
deemed
acceptable.

Since
the
9/
93
RED
Chapter,
the
available
field
rotational
crop
studies,
originally
reviewed
by
EFED,
have
been
evaluated
by
HED.
It
was
concluded
that
the
limited
field
rotational
crop
studies
were
adequate
and
that
additional
data
were
no
longer
needed
to
upgrade
the
confined
rotational
crop
study.
The
available
data
support
rotational
crop
restrictions
of
44
days
for
root
and
leafy
vegetables
and
60
days
for
small
grains
and
other
crops,
which
are
the
established
Amitraz
Residue
Chemistry
Considerations
­
TRED
Barcode:
D300301
12
rotational
crop
restrictions
for
use
of
amitraz
on
cotton.
Rotational
crop
tolerances
are
not
needed.

The
registrants
have
stated
that
they
intend
to
cancel
use
of
amitraz
on
cotton,
the
only
annual
crop
with
registered
uses.
Therefore,
no
data
pertaining
to
confined
and
field
accumulation
in
rotational
crops
are
required.

860.1650
Submittal
of
Analytical
Reference
Standards
As
of
8/
22/
03,
an
analytical
reference
standard
for
amitraz
is
available
at
the
EPA
National
Pesticide
Standards
Repository.
No
reference
standards
for
the
metabolites
BTS­
27919
and
BTS­
27271
are
available.
Amitraz
Residue
Chemistry
Considerations
­
TRED
Barcode:
D300301
13
Table
5.
Residue
Chemistry
Science
Assessment
for
Reregistration
of
Amitraz
(
PC
Code
106201).

GLN
Data
Requirements
Current
Tolerances
(
ppm)
[
§
180.287]
Additional
Data
Needed?
MRID
Nos.
1
860.1200:
Directions
for
Use
N/
A
=
Not
Applicable
No
See
Table
4
and
Appendix
1
860.1300:
Nature
of
the
Residue
­
Plants
N/
A
No
00028664
00028666
00055718
00161022
00161023
405906012
405908013
409995024
41206701
860.1300:
Nature
of
the
Residue
­
Animals
N/
A
No
408113055
409995034
426670016429693017
432871018
860.1340:
Residue
Analytical
Method
­
Plant
Commodities
N/
A
No
00046030
00051929
00051930
GS00234013
421613019
43699901­
4369990310
­
Animal
Commodities
N/
A
No
408113105
860.1360:
Multiresidue
Method
N/
A
No
40811311­
408113125,
11
4129550312
860.1380:
Storage
Stability
Data
­
Plant
Commodities
N/
A
No
00046029
GS00234014
408113095
409995084
­
Animal
Commodities
N/
A
No
408113085
426320016
860.1400:
Magnitude
of
the
Residue
­
Water,
Fish,
and
Irrigated
Crops
N/
A
N/
A
860.1460:
Magnitude
of
the
Residue
­
Food
Handling
N/
A
N/
A
860.1480:
Magnitude
of
the
Residue
­
Meat,
Milk,
Poultry,
Eggs
­
Cattle
fat,
meat,
and
meat
byproducts
0.05,
meat;
0.1,
fat;
0.3,
mbyp
No
No
MRID
No.
13
No
MRID
No.
14
40811306­
408113075
­
Goat
fat,
meat,
and
meat
byproducts
"
0",
fat,
meat,
and
mbyp
No
­
Hog
fat,
meat,
and
meat
byproducts
0.05,
meat;
0.1,
fat;
0.2,
kidney
&
liver;
0.3,
mbyp
No
0016039115
0016207316
­
Horse
fat,
meat,
and
meat
byproducts
None
established17
No
­
Sheep
fat,
meat,
and
meat
byproducts
"
0",
fat,
meat,
and
mbyp
No
Amitraz
Residue
Chemistry
Considerations
­
TRED
Barcode:
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Table
5.
Residue
Chemistry
Science
Assessment
for
Reregistration
of
Amitraz
(
PC
Code
106201).

GLN
Data
Requirements
Current
Tolerances
(
ppm)
[
§
180.287]
Additional
Data
Needed?
MRID
Nos.
1
14
­
Milk
0.03,
milk;
0.3,
milk
fat
No
40811306­
408113075
­
Eggs
and
the
Fat,
Meat,
and
Meat
Byproducts
of
Poultry
0.01,
eggs,
fat,
and
meat;
0.05,
mbyp
No
40999504­
409995054
860.1500:
Crop
Field
Trials
Pome
Fruit
Group
­
Pear
3
No18
00046029
00051717
4337030119
Miscellaneous
Commodities
­
Cotton,
seed
and
gin
byproducts
1.0,
seed
No20
409995064
41444201­
4144420321
­
Honey
1.0,
honey;
6.0,
honeycomb
No22
41295501­
4129550223
­
Hop,
dried
cones
60.0
No
42044502­
420445039
42161302­
421613049
421780019
43369901­
4336990310
860.1520:
Processed
Food/
Feed
­
Cotton
None
established
No20
409995074
4144420221
4147890124
860.1850:
Confined
Accumulation
in
Rotational
Crops
N/
A
No25
4267390126
860.1900:
Field
Accumulation
in
Rotational
Crops
N/
A
No25
4099950927
4163730227
Amitraz
Residue
Chemistry
Considerations
­
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15
1.
Bolded
reference(
s)
were
reviewed
in
the
Update
of
7/
6/
90.
Unbolded
references
were
reviewed
in
the
Residue
Chemistry
Science
Chapter
of
the
Registration
Standard
dated
10/
84.
All
other
references
were
reviewed
as
noted.

2.
CB
Nos.
3515
and
3735,
5/
5/
88,
F.
Suhre.

3.
CB
Nos.
3402
and
3403,
5/
11/
88,
F.
Suhre.

4.
CB
Nos.
5008,
5009,
5020,
5021,
5121,
and
5122;
5/
31/
89;
M.
Flood.

5.
CB
Nos.
4374
and
4375,
1/
10/
89,
M.
Kovacs.

6.
D185748,
D187485,
D188495,
and
D192950,
7/
27/
93,
F.
Griffith.

7.
DP
Barcode
D196559,
2/
15/
94,
C.
Swartz,
and
D210892,
1/
23/
95,
F.
Griffith.

8.
DP
Barcode
D205735,
8/
4/
94,
C.
Swartz.

9.
DP
Barcodes
D174990,
D181748,
and
D181628;
8/
21/
92;
F.
Griffith.

10.
DP
Barcodes
D207742,
D208224,
D208225,
D208229,
D208232,
D208234,
D208247,
D208356,
D208360,
D208365,
and
D208394;
11/
8/
94;
F.
Griffith.

11.
Memo
from
M.
Kovacs
to
L.
Sawyer,
1/
10/
89.

12.
Memo
from
S.
Koepke
to
L.
Sawyer,
4/
19/
90.

13.
45639­
EUP­
9,
2/
2/
83,
R.
Loranger.

14.
83­
PR­
02,
12/
3/
82,
E.
Zager.

15.
PP#
4F3081,
7/
11/
84,
E.
Haeberer.

16.
CB
No.
1241,
10/
15/
86,
F.
Griffith.

17.
Tolerances
for
horse
commodities
have
been
revoked
(
67
FR
49606;
7/
31/
2002).

18.
The
registrant
has
stated
that
they
intend
to
cancel
use
of
amitraz
on
pears.

19.
DP
Barcode
D209191,
11/
18/
94,
C.
Swartz.

20.
The
registrant
has
stated
that
they
intend
to
cancel
use
of
amitraz
on
cotton.

21.
CB
No.
6592,
5/
17/
90,
M.
Flood.

22.
The
previously
registered
uses
of
amitraz
in
beehives
have
been
cancelled.

23.
CB
No.
6046,
5/
7/
90,
S.
Koepke.

24.
CB
No.
6665,
6/
11/
90,
M.
Flood.
Amitraz
Residue
Chemistry
Considerations
­
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16
25.
Because
the
registrant
intends
to
cancel
use
of
amitraz
on
cotton,
the
only
annual
crop
with
registered
uses,
rotational
crop
data
are
no
longer
required.

26.
DP
Barcode
D189026,
7/
20/
93,
G.
Kramer.

27.
DP
Barcode
D195591,
11/
29/
93,
G.
Kramer.
Amitraz
Residue
Chemistry
Considerations
­
TRED
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17
TOLERANCE
REASSESSMENT
SUMMARY
Tolerance
Reassessments
for
Amitraz
Tolerances
for
residues
of
amitraz
in/
on
plant
and
animal
commodities
are
expressed
in
terms
of
the
combined
residues
of
"
amitraz
(
N'­[
2,4­
dimethylphenyl]­
N­[[(
2,4­
dimethylphenyl)
imino]
methyl]]­
N­
methylmethanimidamide)
and
its
metabolites
N­(
2,4­
dimethylphenyl)­
N­
methyl
formamide
and
N­(
2,4­
dimethylphenyl)­
N­
methylmethanimidamide,"
both
calculated
as
the
parent
compound
[
40
CFR
§
180.287].

There
is
an
error
in
the
name
of
one
of
the
metabolites
in
the
tolerance
expression
(
metabolite
BTS­
27919).
Currently
the
chemical
name
for
the
metabolite
reads:
N­(
2,4­
dimethylphenyl)­
N­
methyl
formamide.
The
correct
name
for
the
metabolite
is
as
follows:
N­(
2,4­
dimethylphenyl)
formamide.

The
HED
Chem
SAC
(
3/
31/
04
meeting)
has
recommended
that
the
current
tolerance
expression
for
amitraz
needs
to
be
changed
by
removing
the
reference
to
specific
metabolites.
The
tolerance
expression
should
specify
that
the
terminal
residues
of
concern
for
enforcement
purposes
are
amitraz
and
its
metabolites
containing
the
2,4­
dimethylaniline
moiety.

A
summary
of
the
amitraz
tolerance
reassessments
and
recommended
modifications
in
commodity
definitions
is
presented
in
Table
6.

Tolerances
Listed
Under
40
CFR
§
180.287:

Adequate
residue
data
have
been
submitted
to
reassess
the
established
tolerances
for
the
following
commodities:
cattle,
fat;
cattle,
meat
byproducts;
cattle,
meat;
hog,
fat;
hog,
kidney;
hog,
liver;
hog,
meat
byproducts;
hog,
meat;
hop,
dried
cones;
milk;
and
milk,
fat.
The
available
data
indicate
that
the
established
tolerances
for
cattle
meat
byproducts,
hog
liver
and
kidney,
and
milk
fat
may
be
reduced.
The
tolerances
for
cattle
fat,
hog
fat,
hog
meat
byproducts,
hog
meat,
hop
dried
cones,
and
milk
are
reassessed
at
the
same
level.
We
note
that
for
dried
hops,
because
the
percent
dry
matter
was
not
known
for
all
samples
submitted
in
support
of
the
tolerance
petition,
HED
recommended
a
tolerance
level
higher
than
the
maximum
observed
residues
to
account
for
the
potential
that
the
samples
had
dry
matter
contents
different
from
the
expected
value
of
approximately
85%.

Because
the
tolerance
for
dried
hops
under
40
CFR
§
180.287
is
an
import
tolerance,
the
tolerance
listing
should
be
amended
with
a
footnote
stating
"
No
U.
S.
registrations
as
of
[
date
of
FR
notice]".
The
registrant
has
indicated
that
they
would
like
to
keep
the
cotton
tolerance
as
an
import
tolerance.
HED
notes
that
there
is
a
Codex
MRL
for
cottonseed.
If
a
Codex
MRL
has
been
established,
the
NAFTA
countries
may
conduct
a
more
limited
review
of
the
residue
chemistry
data
under
certain
conditions.
The
NAFTA
countries
are
more
likely
to
adopt
MRLs
similar
to
Codex
MRL
levels
if
MRLs
for
the
pesticide
are
already
established
on
other
commodities
with
a
contemporary
robust
database.
Standard
data
and
review
requirements
Amitraz
Residue
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18
would
be
applied
where
exposure
and/
or
risk
to
any
subpopulation
from
the
pesticide
is
high.
An
EPA­
specific
detailed
description
of
how
the
U.
S.
may
consider
Codex
MRLs
as
they
relate
to
data
requirements
can
be
found
in
Unit
VIII
of
the
U.
S.
Import
Tolerances
Guidance
document
(
65
FR
35069).
The
registrant
needs
to
submit
a
formal
request
to
the
Agency
for
establishment
of
the
cottonseed
tolerance
as
an
import
tolerance,
and
information
about
the
use
pattern
in
foreign
countries,
and
residue
data
from
those
countries
to
support
the
request.
Also,
the
tolerance
listing
should
be
amended
with
a
footnote
stating
"
No
U.
S.
registrations
as
of
[
date
of
FR
notice]".

All
registered
uses
of
amitraz
in
beehives
have
been
cancelled,
and
the
registrants
intend
to
cancel
use
of
amitraz
on
cotton
and
pears
in
the
U.
S.
Therefore,
the
established
tolerances
for
the
following
commodities
should
be
revoked:
cotton,
undelinted
seed;
honey;
honeycomb;
and
pear.
In
addition,
because
there
will
no
longer
be
any
dietary
exposure
of
livestock
to
amitraz,
the
established
tolerances
for
the
following
animal
commodities
should
be
revoked:
egg;
goat,
fat;
goat,
meat
byproducts;
goat,
meat;
poultry
fat/
meat;
poultry
meat
byproducts;
sheep,
fat;
sheep,
meat
byproducts;
and
sheep,
meat.
Tolerances
for
horse
commodities
were
previously
revoked
(
67FR
49606,
7/
31/
02).

Proposed
Tolerances
PP#
9F3772:
Tolerances
have
been
proposed
for
residues
of
amitraz
and
its
metabolites
containing
the
2,4­
dimethylaniline
moiety
in
the
meat,
fat,
and
meat
byproducts
of
goats
and
sheep,
resulting
from
direct
dermal
application,
at
0.2
ppm
in
liver
and
kidney,
0.3
ppm
in
meat
and
meat
byproducts,
and
0.5
ppm
in
fat.
This
petition
has
received
a
favorable
recommendation,
toxicological
considerations
permitting,
(
CB
No.
6466,
6/
4/
90,
R.
Cook).
However,
the
registrant
does
not
intend
to
support
uses
on
goats
and
sheep.

We
note
that
a
petition
to
support
an
amended
registration
request
to
allow
use
of
pour­
on
mineral
oil­
based
formulation
on
swine
had
been
submitted
and
evaluated
by
the
Agency
(
PP#
2F4110).
This
petition
has
been
withdrawn
since
the
9/
93
RED
Chapter
(
60
FR
38333,
7/
26/
95).

Table
6.
Tolerance
Reassessment
Summary
for
Amitraz.

Commodity
Current
Tolerance
(
ppm)
Tolerance
Reassessment
(
ppm)
Comment/[
Correct
Commodity
Definition]

Tolerances
Listed
Under
40
CFR
§
180.287:

Cattle,
fat
0.1
0.04
Cattle,
meat
byproducts
0.3
0.2
Cattle,
meat
0.05
0.02
Cotton,
undelinted
seed
1
1
The
registrant
intends
to
cancel
use
of
amitraz
on
cotton
in
the
US
and
to
retain
the
tolerance
as
an
import
tolerance.
Amitraz
Residue
Chemistry
Considerations
­
TRED
Barcode:
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Table
6.
Tolerance
Reassessment
Summary
for
Amitraz.

Commodity
Current
Tolerance
(
ppm)
Tolerance
Reassessment
(
ppm)
Comment/[
Correct
Commodity
Definition]

19
Egg
0.01
Revoke
When
use
of
amitraz
on
cotton
is
cancelled,
there
will
be
no
need
for
tolerances
for
poultry
commodities.

Goat,
fat
0
Revoke
When
use
of
amitraz
on
cotton
is
cancelled,
there
will
be
no
need
for
tolerances
for
goat
commodities.
Goat,
meat
byproducts
0
Revoke
Goat,
meat
0
Revoke
Hog,
fat
0.1
0.1
Hog,
kidney
0.2
0.1
Hog,
liver
0.2
0.1
Hog,
meat
byproducts
0.3
0.3
Hog,
meat
byproducts,
except
kidney
and
liver
Hog,
meat
0.05
0.05
Honey
1
Revoke
There
are
no
longer
any
registered
uses
of
amitraz
in
beehives.
Honeycomb
6
Revoke
Hop,
dried
cones
60
60
The
following
footnote
should
be
added
to
the
tolerance
listing
for
dried
hop
cones:
"
No
U.
S.
registrations
as
of
[
date
of
FR
notice]."

Milk
0.03
0.03
Milk,
fat
0.3
0.2
Pear
3
Revoke
The
registrant
intends
to
cancel
use
of
amitraz
on
pears.

Poultry
fat/
meat
0.01
Revoke
When
use
of
amitraz
on
cotton
is
cancelled,
there
will
be
no
need
for
tolerances
for
poultry
commodities.
Poultry
meat
byproducts
0.05
Revoke
Sheep,
fat
0
Revoke
When
use
of
amitraz
on
cotton
is
cancelled,
there
will
be
no
need
for
tolerances
for
sheep
commodities.
Sheep,
meat
byproducts
0
Revoke
Sheep,
meat
0
Revoke
Codex/
International
Harmonization
Several
maximum
residue
limits
(
MRLs)
for
amitraz
have
been
established
by
Codex
in
various
commodities.
The
Codex
MRLs
are
currently
expressed
as
the
sum
of
amitraz
and
N­(
2,4­
dimethylphenyl)­
N'­
methylformamidine
calculated
as
N­(
2,4­
dimethylphenyl)­
N'­
methylformamidine.
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The
Codex
tolerance
expression
is
somewhat
different
from
the
U.
S.
tolerance
expression.
The
Codex
expression
is
the
sum
of
amitraz
plus
metabolite
BTS­
27271,
calculated
as
BTS­
27271.
The
U.
S.
expression
is
the
sum
of
amitraz
and
its
metabolites
BTS­
27271
and
BTS­
27919,
both
calculated
as
the
parent
compound.
The
enforcement
methods
for
amitraz
tolerances
in
the
U.
S.
(
Methods
I
and
II
of
PAM
Vol.
II)
consists
of
hydrolysis
of
all
metabolites
containing
the
2,4­
DMA
moiety
to
2,4­
DMA
and
determination
using
gas
chromatography
with
electron
capture
detection.
The
enforcement
method
under
the
Codex
system
involves
treatment
of
the
RAC
with
acidic
methanol
to
convert
the
parent
compound
to
metabolite
BTS­
27271,
followed
by
extraction,
cleanup,
and
determination
of
BTS­
27271
using
gas
liquid
chromatography
with
flame
ionization
detection.
Presently,
compatibility
between
the
Codex
MRL
and
U.
S.
tolerance
cannot
be
achieved
due
to
the
differences
between
the
tolerance
definitions
and
analytical
enforcement
methods.

A
summary
of
the
established
and
proposed
Codex
MRLs
is
presented
in
Table
7.
The
current
U.
S.
tolerances
and
Codex
MRLs
are
identical
in
magnitude
for
cattle
and
pig
meat.
However,
the
reassessed
tolerances
in
the
U.
S.
are
lower
than
Codex
MRLs
with
the
exception
of
milk
which
are
the
same.
There
are
several
Codex
MRLs
for
which
there
are
no
U.
S.
tolerances.

There
is
a
Mexican
MRL
established
for
amitraz
on
cottonseed
at
1.0
mg/
kg.
MRLs
have
been
established
in
Canada
for
amitraz
and
its
metabolite
N­(
2,4­
dimethylphenyl)­
N'­
methyl
formamidine
in/
on
pears
at
1.0
ppm,
apples
at
0.5
ppm,
and
liver
and
kidney
of
cattle
and
hogs
at
0.2
ppm.
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Table
7.
Codex
MRLs
and
Applicable
U.
S.
Tolerances
for
Amitraz.
Recommendations
are
Based
on
Conclusions
Following
Reassessment
of
U.
S.
Tolerances
(
see
Table
6).

Codex
Reassessed
U.
S.
Tolerance,
ppm
Recommendation
And
Comments
Commodity,
As
Defined
MRL
(
mg/
kg)
Step
Cattle
meat
0.051
CXL
0.02
Cherries
0.5
CXL
None
established
No
U.
S.
registrations
for
use
on
cherry.

Cotton
seed
0.5
CXL
1
Registrant
intends
to
cancel
use
on
cotton
in
the
U.
S.
and
retain
the
tolerance
as
an
import
tolerance.

Cotton
seed
oil,
Crude
0.05
CXL
None
established
Cucumber
0.5
CXL
None
established
No
U.
S.
registrations
for
use
on
cucumber.

Edible
offal
of
cattle,
pigs
&
sheep
0.21
CXL
0.1
hog
fat,
hog
kidney
&
liver;
0.04
for
cattle
fat;
and
0.3
hog
mbyp
Revoke
sheep
tolerances
When
use
on
cotton
is
cancelled,
there
will
be
no
need
for
tolerances
on
sheep.

Milks
0.01(*)
1,2
CXL
0.03
Oranges,
Sweet,
Sour
0.5
CXL
None
established
No
U.
S.
registrations
for
use
on
orange.

Peach
0.5
CXL
None
established
No
U.
S.
registrations
for
use
on
peach.

Pig
meat
0.051
CXL
0.05
Pome
fruits
0.5
CXL
Revoke
Registrant
intends
to
cancel
use
on
pears
in
the
U.
S.

Sheep
meat
0.11
CXL
Revoke
When
use
on
cotton
is
cancelled,
there
will
be
no
need
for
tolerances
on
sheep.

Tomato
0.5
CXL
None
established
No
U.
S.
registrations
for
use
on
tomato.

1
The
MRL
accommodates
external
animal
treatment.
2
(*)
=
At
or
about
the
limit
of
determination.
Amitraz
Residue
Chemistry
Considerations
­
TRED
Barcode:
D300301
22
BIBLIOGRAPHY
Study
Citations
00028664
Lewis,
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1980
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43142­
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Wilmington,
Del.;
CDL:
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27
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Metabolism
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AX
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242996­
C)

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36,059
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2,4­
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3­
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1,3,5­
triazapenta­
1,4­
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Mich.;
CDL:
242996­
D)

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B.
L.;
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1976
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submitted
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Co.,
Kalamazoo,
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CDL:
096422­
E)

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Nappier,
J.
L.;
Hornish,
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E.
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1975)
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Method
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Pears
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9760­
32.
Method
dated
Sep
26,
1975.
(
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Dec
18,
1975
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EX­
34;
submitted
by
Upjohn
Co.,
Kalamazoo,
Mich.;
CDL:
094993­
D)

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Upjohn
Company
(
1975)
Comparison
of
the
Analytical
Residue
Procedures
for
U­
36,059
and
U­
40,481
(
Used
in
1973
and
1974)
with
the
Degradative
Procedure
(
Used
in
1975).
(
Unpublished
study
received
Dec
18,
1975
under
1023­
EX­
34;
submitted
by
Upjohn
Co.,
Kalamazoo,
Mich.;
CDL:
094993­
E)

00055718
Somerville,
L.;
Nicholson,
J.
E.
(
1977)
BTS
27
419­­
Metabolism
in
Apples,
Variety
Cox's
Orange
Pippin.
(
Unpublished
study
received
Oct
7,
1974
under
5G1558;
submitted
by
Upjohn
Co.,
Kalamazoo,
Mich.;
CDL:
094250­
C)

00160391
Nor­
Am
Chemical
Co.
(
1984)
Residue
Chemistry:
Discussion
of
Amitraz
Residue
Data
in
Hogs.
Unpublished
compilation.
80
p.
Amitraz
Residue
Chemistry
Considerations
­
TRED
Barcode:
D300301
23
00161022
McGibbon,
A.;
Kelly,
I.
(
1984)
Metabolism
of
Carbon
14­
Amitraz
in
Pears:
(
An
Interim
Report):
Study
No.
44L:
Report
No.
METAB/
84/
4.
Unpublished
study
prepared
by
FBC
Ltd.,
Chesterford
Park
Research
Station.
20
p.

00161023
McGibbon,
A.;
Kelly,
I.
(
1984)
The
Metabolism
of
Carbon
14
¿
­
Amitraz
in
Lemons
under
Glasshouse
Conditions:
(
An
Interim
Report):
Study
No.
52L:
Report
No.
METAB/
84/
6.
Unpublished
study
prepared
by
FBC
Ltd.,
Chesterford
Park
Research
Station.
16
p.

00162073
Nor­
Am
Chemical
Co.
(
1986)
Amitraz
Residues
in
Hog
Skin
and
Processed
Food
Made
from
Hog
Skins.
Unpublished
compilation.
101
p.

40590601
Smith,
S.;
Campbell,
J.
(
1988)
M73
Metabolism
of
Carbon
14­
Amitraz
in
Lemons:
Laboratory
Project
ID
ENVIR/
87/
44.
Unpublished
study
prepared
by
Schering
Agrochemicals
Limited.
64
p.
64
p.

40590801
Fortsch,
A.
(
1988)
M77
Amitraz:
The
Fate
of
Amitraz
in
Cotton:
Late
Season
Application:
Laboratory
Project
ID
UPSR
5/
88.
Unpublished
study
prepared
by
Schering
AG.
76
p.

40811305
Phillips,
M.;
Swalwell,
L.;
Needham,
D.
(
1988)
M74­­
Identification
of
Metabolites
of
Amitraz
in
the
Milk
and
Meat
of
a
Cow
Dosed
for
4
Days
with
Amitraz:
Report
No.
ENVIR/
87/
46.
Unpublished
study
prepared
by
Schering
Agrochemicals
Ltd.
31
p.

40811306
Manley,
J.;
Snowden,
P.
(
1988)
R274
Amitraz­
derived
Residues
Containing
the
2,4­
Dimethylaniline
Moiety
in
the
Tissue
and
Milk
of
Cattle
Following
a
28
Day
Feeding
Study
in
the
UK,
1987:
Laboratory
Project
ID
RESID/
87/
117.
Unpublished
study
prepared
by
Schering
Agrochemicals
Ltd.
44
p.

40811307
Roberts,
N.;
Cameron,
D.;
Redgrave,
V.
(
1988)
R274A
Amitraz
Technical
Residues
in
Milk
and
Tissues
of
Dairy
Cows­­
Animal
Phase:
Laboratory
Project
ID
SMS/
81/
884:
Sponsor's
Project
No.
082/
05/­
011.
Unpublished
study
prepared
by
Huntingdon
Research
Centre.
29
p.

40811308
Manley,
J.;
Snowdon,
P.
(
1988)
R
249
Stability
of
Amitraz,
BTS
272­
71,
and
BTS
27919
Residues
in
Animal
Tissues
and
Milk
During
Deep
Freeze
Storage:
Laboratory
Project
ID
RESID/
87/
122.
Unpublished
study
prepared
by
Schering
Agrochemicals
Ltd.
31
p.

40811309
Chambers,
J.;
Longland,
R.;
Stalley,
F.
(
1988)
R222
2nd
edn.­­
Stability
of
the
Amitraz
Metabolites
BTS
27271
and
BTS
27919
in
Oranges
During
Deep
Freeze
Storage:
Interim
Report
to
18
Months:
Laboratory
Project
ID
RESID/
87/
125.
Unpublished
study
prepared
by
Schering
Agrochemicals
Ltd.
38
p.

40811310
Manley,
J.;
Snowdon,
P.
(
1988)
R206
2nd
edn.­­
Analytical
Method
for
the
Determination
of
Combined
Residues
of
Amitraz
and
Metabolites
Hydrolysing
to
2,4­
Amitraz
Residue
Chemistry
Considerations
­
TRED
Barcode:
D300301
24
Dimethylaniline
in
Animal
Tissues,
Milk
and
Eggs
by
Gas
Chromatography:
Laboratory
Project
ID
RESID/
87/­
108.
Unpublished
study
prepared
by
Schering
Agrochemicals
Ltd.
42
p.

40811311
Castro,
L.
(
1988)
R254
Behaviour
of
Amitraz,
BTS
27271­
HCl,
and
BTS
27919
Through
EPA
Multiresidue
Protocol
II:
Laboratory
Project
ID
12013A.
Unpublished
study
prepared
by
Nor­
Am
Chemical
Co.
35
p.

40811312
Bardalaye,
P.
(
1988)
R259
Amitraz
and
its
Metabolites,
BTS
27217
and
BTS
27919,
Through
EPA
Multiresidue
Protocol
III:
Laboratory
Project
ID
12013B.
Unpublished
study
prepared
by
Nor­
Am
Chemical
Co.
30
p.

40999502
Fortsch,
A.
(
1988)
M79
the
Fate
of
Amitraz
in
Cotton
Seed:
Project
ID:
UPSR
73/
88.
Unpublished
study
prepared
by
Schering
Ag.
52
p.

40999503
Needham,
D.;
Hemmings,
P.
(
1988)
(
M75)
the
Metabolism
and
Distribution
of
Amitraz
Residues
in
the
Laying
Hen
Following
the
Daily
Oral
Administration
of
24.5
mg
carbon
14­
Amitraz
per
Bird
for
4
Days:
Project
ID:
Envir/
88/
6.
Unpublished
study
prepared
by
Schering
Agrochemicals
Ltd.
40
p.

40999504
Manley,
J.;
Snowdon,
P.
(
1988)
R266
Amitraz
Derived
Residues
Containing
the
2,4­
Dimethylaniline
Moiety
in
the
Tissue
and
Eggs
of
Laying
Hens
Following
a
28­
Day
Feed
Study
in
the
UK,
1987:
Project
ID:
RESID/
88/
42.
Unpublished
study
prepared
by
Schering
Agrochemicals
Ltd.
38
p.

40999505
Roberts,
N.;
Hakin,
B.
(
1988)
R266A
Amitraz
Technical:
Residues
in
the
Eggs
and
Tissues
of
the
Laying
Hen
Following
Administration
by
Oral
Gavage
for
28
Days:
Project
ID:
RESID/
88/
42.
Unpublished
study
prepared
by
Huntingdon
Research
Centre.
39
p.

40999506
Catro,
L.
(
1988)
R257:
Total
Terminal
Residues
of
Amitraz
and
its
Major
Metabolites
in
Ginned
Cottonseed
Resulting
from
Application
of
Mitac
EC
in
Trials
Conducted
in
the
USA
in
1987:
Project
ID:
12016.
Unpublished
study
prepared
by
NOR­
AM
Chemical
Co.
70
p.

40999507
Castro,
L.
(
1988)
(
R258)
Effects
of
Processing
on
Total
Residues
of
Amitraz,
BTS
27271,
AND
bts
27919
in
Ginned
Cottonseed
from
Trials
Conducted
in
the
USA
in
1987:
Project
ID:
12017.
Unpublished
study
prepared
by
NOR­
AM
Chemical
Co.
51
p.

40999508
Kelly,
I.
(
1988)
(
R262)
Frozen
Storage
Stability
of
Amitraz
in
Cottonseed:
Project
ID:
12004.
Unpublished
study
prepared
by
NOR­
AM
Chemical
Co.
22
p.

40999509
Castro,
L.
(
1988)
R272
=
W104:
Residues
of
Amitraz
and
its
Major
Metabolites
in
Soil
and
Rotational
Crops
Following
Application
of
Mitac
EC
to
Cotton:
Project
ID:
12010.
Unpublished
study
prepared
by
NOR­
AM
Chemical
Co.
95
p.
Amitraz
Residue
Chemistry
Considerations
­
TRED
Barcode:
D300301
25
41206701
Smith,
S.
(
1989)
M80
The
Metabolism
of
Amitraz
in
Pears:
Proj.
ID
ENVIR/
89/
21.
Unpublished
study
prepared
by
Schering
Agrochemicals
Ltd.
47
p.

41295501
Brady,
S.
(
1989)
R294:
Amitraz:
Residues
of
Amitraz
in
Honey
and
Beeswax
from
Hives
Treated
with
10.0%
Amitraz
Strips
in
North
Carolina,
1989:
Lab
Project
Number:
R122/
12/
89.
Unpublished
study
prepared
by
Nor­
Am
Chemical
Co.
46
p.

41295502
Brady,
S.
(
1989)
R295:
Amitraz:
Residues
of
Amitraz
in
Honey
and
Beeswax
from
Hives
Treated
with
10.0%
Amitraz
Strips
for
104
Days,
Florida,
1989:
Lab
Project
Number:
R122/
06/
89.
Unpublished
study
prepared
by
Nor­
am
Chemical
Co.
46
p.

41295503
Bardalaye,
P.
(
1989)
R259
Amitraz
and
Its
Metabolites,
BTS
27271
and
BTS
17919,
Through
EPA
Multiresidue
Protocol
III:
Lab
Project
Number:
12013B.
Unpublished
study
prepared
by
Nor­
Am
Chemical
Co.
30
p.

41444201
Brady,
S.;
Castro,
L.
(
1990)
(
R296)
Total
Residues
of
Amitraz
and
Major
Metabolites
at
Harvest
in
Cottonseed
Treated
with
Ovasyn,
USA
1988:
Lab
Project
Number:
R122.01.88.
Unpublished
study
prepared
by
NOR­
AM
Chemical
Co.
291
p.

41444202
Brady,
S.
(
1989)
(
R258)
Amendment
1:
Effects
of
Processing
on
Total
Residues
of
Amitraz,
BTS
27271,
and
BTS
27929
in
Ginned
Cottonseed
from
Trials
Conducted
in
the
USA
in
1987:
Lab
Project
Number:
12017.
Unpublished
study
prepared
by
NOR­
AM
Chemical
Co.
18
p.

41444203
Snowdon,
P.
(
1988)
(
R266­
Addendum)
Amitraz
Derived
Residues
Contain
ing
2,4­
Dimethylaniline
Moiety
in
the
Tissues
and
Eggs
of
Laying
Hens
Following
a
28­
day
Feeding
Study
in
the
UK,
1987:
Lab
Project
Number:
RESID/
88/
42.
Unpublished
study
prepared
by
Schering
Agrochemicals
Ltd.
27
p.

41478901
Brady,
S.
(
1989)
Total
Amitraz­
derived
Residues
in
Ginned
Cottonseed
and
Hulls
following
Applications
of
Ovasyn
to
Cotton
prior
to
Boll
Opening,
USA
1989:
Study
Number:
R122.15.89.
Unpublished
study
prepared
by
Nor­
am
Chemical
Co.
62
p.

41637302
Castro,
L.
(
1990)
Residues
of
Amitraz
in
Rotational
Crops
following
Treatment
of
Cotton
with
Ovasyn,
USA
1988/
1989:
Lab
Project
Number:
R122.08.88.
Unpublished
study
prepared
by
Analytical
BioChemistry
Laboratories,
Inc.
494
p.

42044502
Cron,
J.
(
1982)
R146­
Amitraz:
Analysis
of
Residues
in
Hops
From
Trials
with
Amitraz
in
the
UK,
1980:
Lab
Project
Number:
RESID/
82/
85.
Unpublished
study
prepared
by
Schering
Agrochemicals
Limited.
16
p.

42044503
Chambers,
J.;
Snowdon,
P.
(
1991)
R305
Amitraz­
Derived
Residues
Containing
the
2,4­
Dimethylaniline
Moiety
in
Hops,
Spent
Hops
and
Beer
Following
Application
of
a
20EC
Formulation
in
the
Federal
Republic
of
Germany
1988:
Lab
Project
Number:
RESID/
90/
115.
Unpublished
study
prepared
by
Schering
Agrochemical
Ltd.
28
p.
Amitraz
Residue
Chemistry
Considerations
­
TRED
Barcode:
D300301
26
42161301
Longland,
R.
(
1987)
R64­
2nd
Edn:
Amitraz:
Method
of
Analysis
for
Residues
of
Amitraz
and
All
Metabolites
Hydrolysing
to
2,4­
dimethylaniline
in
Miscellaneous
Crops:
Lab
Project
Number:
RESID/
86/
91.
Unpublished
study
prepared
by
Schering
Agrochemicals
Ltd.
91
p.

42632001
Castro,
L.
(
1993)
Frozen
Storage
Stability
of
Amitraz
and
Its
Major
Metabolites
BTS
27271
and
BTS
27919
in
Hog
Fat
and
Muscle:
Lab
Project
Number:
12001.
Unpublished
study
prepared
by
Nor­
Am
Chemical
Co.
47
p.

42667001
Vukich,
J.
(
1993)
Discussion
of
the
Metabolism
Database
Available
for
Amitraz.
Unpublished
study
prepared
by
Nor­
Am
Chemical
Company.
15
p.

42673901
Fordham,
L.;
Campbell,
J.
(
1993)
M83
(
AMITRAZ):
The
Uptake
of
Amitraz
and
its
Soil
Metabolites
by
Rotational
Crops
(
Wheat,
Lettuce,
Radish)
and
Emergency
Plantings
under
Glasshouse
Conditions:
Lab
Project
Number:
ENVIR/
93/
001:
107L.
Unpublished
study
prepared
by
Schering
Agrochemicals
Ltd.
112
p.

42812801
Lauber,
J.;
Kanter,
S.
(
1993)
Survey
of
Swine
Experts
Concerning
the
Pre­
Slaughter
Interval
(
Time
between
Treatment
and
Slaughter)
with
the
Use
of
Taktic
Emulsifiable
Concentrate
Miticide/
Insecticide
and/
or
Taktic
Linebacker
Pour­
On
Insecticide.
Unpublished
study
prepared
by
Hoechst­
Roussel
Agri­
Vet
Co.
44
p.

42969301
Hawkins,
D.;
Elsom,
L.;
Winwick,
T.
et
al.
(
1993)
An
Investigation
of
the
Nature
of
the
Tissue
Metabolites
in
Pigs
Following
Dermal
Administration
of
(
carbon
14)­
Amitraz:
Lab
Project
Number:
HST/
392.
Unpublished
study
prepared
by
Huntingdon
Research
Centre
Ltd.
153
p.

43287101
Hawkins,
D.;
Elsom,
L.;
Curtis,
R.
et
al.
(
1994)
Response
to
EPA
Memorandum
dated
February
15,
1994:
Amitraz:
Reregistration
List
A
Case
No.
0234/
Chemical
ID
No.
106201.
Nature
of
the
Residue
in
Pigs
Following
Dermal
Application
of
(
carbon
14)­
Amitraz.
MRID
No.
42969301.
CBRS
No.
12801.
DB
Barcode
No.
D196559:
Lab
Project
Number.
Unpublished
study
prepared
by
Huntingdon
Research
Center
Ltd.,
Hoechst
Veterinar
Gmbh.
24
p.

43369901
Snowdon,
P.
(
1993)
Amitraz
20
EC
(
CR
19055:
Mitac
HF),
Green
and
Dried
Hops:
Combined
AI
and
Metabolite
Residues;
Germany
1992:
Lab
Project
Number:
RESID/
93/
36:
R346:
082/
03/
117.
Unpublished
study
prepared
by
Schering
Agrochemicals
Ltd.
24
p.

43369902
Snowdon,
P.
(
1993)
Amitraz
20
EC
(
CR
19055:
Mitac
HF),
Green
and
Dried
Hops:
Combined
AI
and
Metabolite
Residues;
Czechoslovakia
1992:
Lab
Project
Number:
RESID/
93/
38:
R348:
082/
03/
119.
Unpublished
study
prepared
by
Schering
Agrochemicals
Ltd.
24
p.
Amitraz
Residue
Chemistry
Considerations
­
TRED
Barcode:
D300301
27
43369903
Snowdon,
P.
(
1993)
Amitraz
20
EC
(
CR
19055:
Mitac
HF),
Green
and
Dried
Hops:
Combined
AI
and
Metabolite
Residues;
UK
1992:
Lab
Project
Number:
RESID/
93/
89:
R352:
082/
03/
120.
Unpublished
study
prepared
by
Schering
Agrochemicals
Ltd.
24
p.

43370301
Brady,
S.
(
1994)
At­
harvest
Residues
of
Amitraz
In
or
On
Pears
Resulting
from
Two
Applications
of
Mitac
EC
or
Mitac
WP
Using
Both
a
14­
Day
and
a
30­
Day
Interval
Between
Applications,
USA
and
Canada,
1991:
Lab
Project
Number:
L­
91R­
01:
JES­
01:
108­
065.
Unpublished
study
prepared
by
Nor­
Am
Chemical
Co.
173
p.
Amitraz
Residue
Chemistry
Considerations
­
TRED
Barcode:
D300301
28
Agency
Memoranda
Citations
Table
8.
Agency
Memoranda
Citations.

Date
DP
Barcode
CB
No.
From
To
MRID
Nos.
Subject
12/
3/
82
­­
­­
E.
Zager
C.
Trichilo
and
Toxicology
Branch
None
83­
PR­
02.
Proposed
Section
18
exemption
for
the
use
of
amitraz
on
cattle,
goats,
and
sheep
in
Puerto
Rico.

2/
2/
83
­­
­­
R.
Loranger
J.
Ellenberger
and
Toxicology
Branch
None
45639­
EUP­
9.
Request
for
use
of
amitraz
in
ear
tags
on
beef
cattle
and
hogs.

7/
11/
84
­­
­­
E.
Haeberer
J.
Ellenberger
and
Toxicology
Branch
00143111
00160391
PP#
4F3081.
Amitraz
in
the
Meat,
Fat,
and
Meat
By­

Products
of
Hogs.
Evaluation
of
Analytical
Methods
and
Residue
Data.

10/
15/
86
­­
1241
F.
Griffith
D.
Edwards
and
Toxicology
Branch
00162073
PP#
4F3081.
Amitraz
in
the
Meat,
Fat,
and
Meat
Byproducts
of
Hogs.
Evaluation
of
the
July
9,
1986
Amendment.

5/
5/
88
­­
3515
and
3735
F.
Suhre
D.
Edwards
40590601
PP#
2F2705/
FAP#
2H5353;
45639­
EUP;
Amitraz
for
Use
on
Citrus.

5/
11/
88
­­
3402
and
3403
F.
Suhre
D.
Edwards
40590801
PP#
7G3547;
45639­
EUP­
27;
Amitraz
for
Use
on
Cotton;

Revised
Section
G.

1/
10/
89
­­
4374
and
4375
M.
Kovacs
D.
Edwards
and
Toxicology
Branch
II
40811300­
40811312
PP#
2F2705/
FAP#
2H5353
­
Amitraz
on
Citrus
Fruits
­

Amendment
of
August
26,
1988.

1/
10/
89
 
 
M.
Kovacs
L.
Sawyer
40811311­
40811312
Submission
of
Multiresidue
Test
Information
for
Amitraz
to
FDA.

5/
31/
89
­­
5008,
5009,

5020,
5021,

5121,
and
5122
M.
Flood
D.
Edwards
and
Toxicology
Branch
40999501­
40999508
PP#
9F3742:
45639­
EUP­
39.
OVASYN
Insecticide/
Miticide
(
Amitraz)
in/
on
Cotton.

PP#
9F3730:
45639­
RUA:
OVASYN
(
Amitraz)
in/
on
Cotton.

4/
19/
90
­­
­­
S.
Koepke
L.
Sawyer
41295503
Submission
of
Multiresidue
Test
Information
for
Amitraz
to
FDA.
Amitraz
Residue
Chemistry
Considerations
­
TRED
Barcode:
D300301
Table
8.
Agency
Memoranda
Citations.

Date
DP
Barcode
CB
No.
From
To
MRID
Nos.
Subject
29
5/
7/
90
­­
6046
S.
Koepke
D.
Edwards/
P.

Johnson
and
Toxicology
Branch
I
41295500­
41295503
PP#
0F3825
Amitraz
on/
in
honey
and
beeswax.

Evaluation
of
Analytical
Methods
and
Residue
Data.

5/
17/
90
­­
6592
M.
Flood
D.
Edwards
41444200­
41444203
PP#
9F3730:
OVASYN
Insecticide/
Miticide
(
Amitraz)

in/
on
Cotton.

6/
4/
90
­­
6446
R.
Cook
D.
Edwards
None
PP#
9F3772
Amitraz
in
Meat,
Fat,
and
Meat
Byproducts
of
Goats
and
Sheep.
Amended
Section
F
and
B.

Submission
dated
2/
19/
90.

6/
11/
90
­­
6665
M.
Flood
D.
Edwards
and
Toxicology
Branch
41478901
PP#
9F3730.
OVASYN
®
Insecticide/
Miticide
(
Amitraz)

in/
on
Cotton.
Submission
dated
5/
8/
90.

12/
31/
91
D162246
7747
C.
Swartz
D.
Edwards
41798705
41798706
Amitraz.
Request
for
registration
of
a
new
pour­
on
mineral
oil­
based
formulation
of
Taktic
®
to
control
lice
and
mange
mites
on
hogs.
EPA
ID.
No.
45639­
RUO.

4/
6/
92
D173972
9371
C.
Swartz
M.
Fiol
42133501
Amitraz.
ID
No.
106201.
List
A
Reregistration
Case
No.
0234.

7/
20/
92
None
None
C.
Swartz
The
Metabolism
Committee
None
Amitraz.
List
A
Reregistration
Case
No.
0234.

Outcome
of
the
7/
15/
92
Meeting
of
the
HED
Metabolism
Committee.

8/
21/
92
D174990,

D181748,

and
D181628
9299,
10401,
and
10412
F.
Griffith
D.
Edwards
and
Toxicology
Branch
42161301­
42161305
42178001
42044501­

42044503
FAP
#
2H5618
­
Amitraz
(
Mitac
®
)
on
Dried
Hops.

Evaluation
of
Analytical
Method
and
Residue
Data,
and
the
August
12
and
17,
1992
Amendments.

9/
25/
92
D176531,

D181751,

and
D182145
9682,
10400,
and
10511
F.
Griffith
D.
Edwards
and
Toxicology
Branch
41798705
42247501
PP#
2F4110
­
Amitraz
(
Taktic
®
)
on
Hogs.
Review
of
Residue
Data
and
Analytical
Methods
and
Amendments
of
August
17
and
21,
1992.
Amitraz
Residue
Chemistry
Considerations
­
TRED
Barcode:
D300301
Table
8.
Agency
Memoranda
Citations.

Date
DP
Barcode
CB
No.
From
To
MRID
Nos.
Subject
30
9/
29/
92
D179596
10058
F.
Griffith
D.
Edwards
and
J.
Kariya
None
PP#
6F1872
Amitraz
on
Pears,
PP#
4F3081
and
2F4110
Amitraz
on
Hogs,
PP#
0F3825
Amitraz
on
Honey
and
Beeswax,
PP#
9F3730
Amitraz
on
Cottonseed,
Poultry,

and
Eggs,
PP#
9F3772
Amitraz
in
Sheep
and
Goats,

FAP#
2H5618
Amitraz
on
Dried
Hops.
Anticipated
Dietary
Exposure
Estimates.

12/
29/
92
D185142
10964
L.
Cheng
M.
Fiol
None
Amitraz.
Swine
Dermal
Metabolism
Protocol.

7/
20/
93
D189026
11538
G.
Kramer
D.
Edwards
42673901
ID#
045639­
RUA
Ovasyn.
Review
of
confined
rotational
study
of
amitraz
(
N'­[
2,4­
Dimethylphenyl]­
N­

[[(
2,4­
dimethylphenyl)
imino]
methyl]­

Nmethylmethanimidamide

7/
27/
93
D185748,

D187485,
D188495,

and
D192950
11052,
11310,
11431,
and
12228
F.
Griffith
D.
Edwards
42496001
41068401­

41068404
40650707
42632001
42667001
PP#
2F4110
­
Amitraz
(
Taktic
®
)
on
Hogs.
Review
of
the
December
16,
1992;
January
19,
February
12,
and
July
12,
1993,
Amendments.

8/
4/
93
D189989
11698
F.
Griffith
D.
Edwards
and
A.
Kocialski
None
PP#
6F1872
­
Amitraz
on
Pears,
PP#
4F3081
and
PP#

2F4110
­
Amitraz
on
Hogs,
PP#
0F3825
­
Amitraz
on
Honey
and
Beeswax,
PP#
9F3730
­
Amitraz
on
Cottonseed,
Poultry,
and
Eggs,
PP#
9F3772
­
Amitraz
in
Sheep
and
Goats,
FAP#
2H5618
­
Amitraz
on
Dried
Hops.
Anticipated
Dietary
Exposure
Estimates,

Addendum.

8/
20/
93
D186339
and
D192447
11122
and
12073
F.
Griffith
R.
Quick
42812801
PP#
2F4110
­
Amitraz
(
Taktic
®
)
on
Hogs.
Review
of
the
Petitioner's
Minutes
from
the
December
14,
1992
Meeting
with
EPA,
and
Use
Data
for
a
Longer
PSI.

9/
17/
93
D192357
12032
C.
Swartz
N.
Thoa
None
Amitraz.
List
A
Case
No.
0234/
Chemical
ID
No.

106201.
Reregistration
Eligibility
Document:
Product
and
Residue
Chemistry
Chapters.

11/
29/
93
D195591
12643
G.
Kramer
D.
Edwards
41637302
40999509
ID#
045639­
00146
Amitraz.
Review
of
limited
field
rotational
crop
studies.
Amitraz
Residue
Chemistry
Considerations
­
TRED
Barcode:
D300301
Table
8.
Agency
Memoranda
Citations.

Date
DP
Barcode
CB
No.
From
To
MRID
Nos.
Subject
31
2/
15/
94
D196559
12801
C.
Swartz
L.
Propst
and
D.

Edwards
42969301
Amitraz.
Reregistration
List
A
Case
No.
0234/
Chemical
ID
No.
106201.
Nature
of
the
Residue
in
Pigs
Following
Dermal
Application
of
14C­
Amitraz.

7/
27/
94
D205793
14068
C.
Swartz
D.
Edwards
None
Amitraz.
List
A
Reregistration
Case
No.
0234/
Chemical
ID
No.
106201.
Anticipated
Residues
in
Pears.

8/
4/
94
D205735
14088
C.
Swartz
E.
Saito
and
D.

Edwards
None
Amitraz.
Reregistration
List
A
Case
No.
0234/
Chemical
ID
No.
106201.
Hoechst­
Roussel
Submission
to
Upgrade
a
Swine
Dermal
Metabolism
Study.

8/
18/
94
D206605
14188
C.
Swartz
D.
Edwards
None
Amitraz.
List
A
Reregistration
Case
No.
0234/
Chemical
ID
No.
106201.
Anticipated
Residues
in
Pears.

9/
8/
94
D207131
14291
C.
Swartz
D.
Edwards
None
Amitraz.
List
A
Reregistration
Case
No.
0234/
Chemical
ID
No.
106201.
Revised
Anticipated
Residues
in
Pears.

9/
20/
94
D197514
and
D205238
12939
and
14056
F.
Griffith
D.
Edwards
None
PP#
2F4110
­
Amitraz
(
Taktic
®
)
on
hogs.
Review
of
the
December
7,
1993,
Amendment
and
RD
Concerns
on
the
Dermal
Metabolism
Study.

11/
8/
94
D207742,

D208224,
D208225,
D208229,
D208232,
D208234,
D208247,
D208356,
D208360,
D208365,

and
D208394
14418,
14516­

14520,
14522,
14539,
14540,
14542,
and
14543
F.
Griffith
D.
Edwards
and
A.
Kocialski
43369901­
43369903
PP#
4E4349
­
Amitraz
(
Mitac
®
)
on
Hops.
Evaluation
of
residue
data
and
analytical
method
and
the
October
12
and
17,1994
amendments.

11/
18/
94
D209191
14673
C.
Swartz
D.
Edwards
43370301
Amitraz.
List
A
Reregistration
Case
No.
0234/
Chemical
ID
No.
106201.
Inclusion
of
Residue
Data
Generated
to
Support
Registration
of
Amitraz
for
Use
on
Pears
in
Canada
in
the
Anticipated
Residue
Assessment
for
Pears.
Amitraz
Residue
Chemistry
Considerations
­
TRED
Barcode:
D300301
Table
8.
Agency
Memoranda
Citations.

Date
DP
Barcode
CB
No.
From
To
MRID
Nos.
Subject
32
12/
2/
94
D209867
14743
C.
Swartz
D.
Edwards
43396802
Amitraz.
List
A
Reregistration
Case
No.
0234/
Chemical
ID
No.
106201.
Consideration
of
Pear
Processing
Data.

12/
8/
94
None
None
N.
Thoa
and
J.

Redden
E.
Saito
None
The
Revised
HED
Chapter
of
the
Reregistration
Eligibility
Decision
Document
(
RED)
for
Amitraz,
Case
#
0234
(
Pesticide
Chemical
Code
106201;
Reg.
Group
A)

1/
12/
95
D210571
14886
F.
Griffith
D.
Edwards
and
A.
Kocialski
None
PP#
4E4349
­
Amitraz
(
Mitac
®
)
on
Hops.
Evaluation
of
the
November
28,
1994,
amendment.

1/
23/
95
D210892
14963
F.
Griffith
D.
Edwards
43287101
PP#
2F4110
­
Amitraz
(
Taktic
®
)
on
hogs.
Review
of
the
submission
to
Upgrade
the
Porcine
Dermal
Metabolism
Study.

2/
16/
95
D211688
15073
F.
Griffith
D.
Edwards
and
J.
Smith
None
PP#
2F4110
­
Amitraz
(
Taktic
®
)
on
Hogs.
Review
of
the
February
1,
1995,
Amendment.
Amitraz
Residue
Chemistry
Considerations
­
TRED
Barcode:
D300301
33
APPENDIX
1
Food/
Food
Use
Pattern
Table
for
Amitraz
Generated
by
BEAD/
OPP
