December
11,
2001
MEMORANDUM:

SUBJECT:
Lindane
(009001):
Reregistration
Case
0315.
Revised
Product
and
Residue
Chemistry
Chapters
for
the
Lindane
Reregistration
Eligibility
Document
(RED).
DP
Barcode:
D279259.

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

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

TO:
Rebecca
Daiss,
Risk
Assessor
Reregistration
Branch
4
Health
Effects
Division
(7509C)

And
Mark
Howard/
Betty
Shackleford
Reregistration
Branch
3
Special
Review
&
Reregistration
Division
(7508C)

Attached
are
the
revised
Product
and
Residue
Chemistry
Chapters
for
the
lindane
RED.
The
chapters
were
assembled
by
Dynamac
Corporation
under
supervision
of
HED.
The
data
assessment
has
undergone
secondary
review
in
the
branch
and
has
been
revised
to
reflect
branch
policies.
This
memorandum
serves
to
update
the
Product
and
Residue
Chemistry
Chapter
(T.
Morton,
6/
7/
01,
D274754)
by
incorporating
comments
from
the
public
comment
period
and
incorporating
submissions
reviewed
by
the
Agency
since
9/
26/
00.
Only
uses
supported
for
reregistration
by
Inquinosa
are
included.
2
EXECUTIVE
SUMMARY:

Product
Chemistry

Pertinent
product
chemistry
data
remain
outstanding
for
the
Inquinosa
99.5%
T/
TGAI
concerning
product
identity,
starting
materials
and
production
process,
preliminary
analysis,
certified
limits,
oxidation/
reduction,
explodability,
storage
stability,
corrosion
characteristics,
and
UV/
visible
absorption
(OPPTS
830.1550,
1600,
1620,
1700,
1750,
6314,
6316,
6317,
6320,
and
7050).
Technical
products
registered
to
Kanoria
Chemicals
&
Industries
were
suspended
effective
12/
5/
00
for
failure
to
comply
with
a
cost
sharing
agreement
with
Inquinosa.
Therefore,
all
technical
products
registered
which
are
repackages
of
the
Kanoria
products
would
be
required
to
change
suppliers.
The
Prentiss,
Drexel,
and
Amvac
99.5%
Ts
are
repackaged
from
EPA­
registered
products,
and
all
data
requirements
will
be
satisfied
by
data
for
the
technical
source
products.
Provided
that
the
registrants
submit
the
data
required
in
the
attached
data
summary
tables
for
the
lindane
T/
TGAIs,
and
either
certify
that
the
suppliers
of
beginning
materials
and
the
manufacturing
processes
have
not
changed
since
the
last
comprehensive
product
chemistry
reviews
or
submit
complete
updated
product
chemistry
data
packages,
the
Branch
has
no
objections
to
the
reregistration
of
lindane
with
respect
to
product
chemistry
data
requirements.

Residue
Chemistry

The
Agency
will
not
require
a
new
confined
rotational
crop
study
provided
the
registrants
propose
a
30­
day
plantback
interval
for
leafy
vegetables
and
a
12­
month
plantback
interval
for
all
other
unregistered
crops
on
all
of
their
end­
use
product
labels
for
lindane.
The
registrants
have
informed
the
Agency
they
will
propose
the
specified
plantback
intervals.


A
new
nature
of
the
residue
study
is
required
for
application
of
lindane
as
a
seed
treatment
to
a
cereal
grain.


If
the
HED
Metabolism
Assessment
Review
Committee
determines
the
residues
of
concern
to
include
metabolites
in
addition
to
lindane,
then
additional
crop
field
trial
data,
magnitude
of
the
residue
in
poultry
and
cattle,
and
processing
studies
are
required.
In
addition,
an
adequate
residue
analytical
method
and
storage
stability
data
will
be
required.
3
Dietary
Exposure/
Risk
Assessment

Anticipated
residues
(DP
Barcode
D279260,
T.
Morton,
12/
4/
01)
will
be
provided
for
all
commodities
and
should
be
used
when
calculating
the
dietary
risk
associated
with
the
RED.
Although
the
database
for
lindane
is
substantially
complete,
additional
data
are
needed
to
eliminate
the
uncertainties
associated
with
the
exposure/
risk
assessment.
The
anticipated
residue
values
are
the
best
estimates
HED
can
provide
using
the
residue
data
available
at
the
time
of
the
RED.
These
values
have
an
inherent
uncertainty
associated
with
variations
in
analytical
methods,
geographical
representation
of
field
trials,
seasonal
variation
of
residue
levels,
use
of
TRR
from
metabolism
studies,
etc.

cc
:
Chem
F,
Chron
F.
Morton
,
Shallal
RDI:
ChemSAC:
9/
13/
00;
SVH:
12/
11/
01
TM,
Thurston
Morton,
Rm.
816D
CM2,
305­
6691,
mail
code
7509C
4
LINDANE
Case
0315;
PC
Code
009001
D279259
Reregistration
Eligibility
Decision:
Product
Chemistry
Considerations
December
11,
2001
Contract
No.
68­
W­
99­
053
Submitted
to:
U.
S.
Environmental
Protection
Agency
Arlington,
VA
Submitted
by:
Dynamac
Corporation
2275
Research
Boulevard
Rockville,
MD
22850­
3268
5
Cl
Cl
Cl
Cl
Cl
Cl
LINDANE
REREGISTRATION
ELIGIBILITY
DECISION:

PRODUCT
CHEMISTRY
CONSIDERATIONS
Case
No.
0315;
PC
Code
009001
DESCRIPTION
OF
CHEMICAL
Lindane
(gamma
isomer
of
benzene
hexachloride,
gamma
isomer
of
hexachlorocyclohexane)
is
a
broad­
spectrum
organochlorine
insecticide/
acaricide
registered
for
control
of
insects
and
other
invertebrates.
The
only
registered
food/
feed
use
is
seed
treatment
for
field
and
vegetable
crops.

Empirical
Formula:
C6
H6
Cl6
Molecular
Weight:
290.9
CAS
Registry
No.:
58­
89­
9
PC
Code:
009001
IDENTIFICATION
OF
ACTIVE
INGREDIENT
Lindane
is
a
white
crystalline
solid
with
a
melting
point
of
112­
113
C,
specific
gravity
of
1.85,
octanol/
water
partition
coefficient
(Kow
)
of
3135,
and
vapor
pressure
of
9.4
x
10
­6
mm
Hg
at
20
C.
Lindane
is
soluble
in
water
(10
ppm
at
20
C)
and
most
organic
solvents,
including
acetone
and
aromatic
and
chlorinated
hydrocarbons.
Lindane
is
only
slightly
soluble
in
mineral
oils.
Lindane
is
stable
to
light,
heat,
air,
and
strong
acids,
but
decomposes
upon
exposure
to
trichlorobenzenes
and
HCl
in
alkali.

MANUFACTURING­
USE
PRODUCTS
According
to
a
search
of
the
Reference
Files
System
(REFS)
conducted
5/
29/
01,
there
are
eight
registered
manufacturing­
use
products
(MPs)
under
PC
Code
009001.
The
registered
MPs
subject
to
a
reregistration
eligibility
decision
are
listed
in
Table
1.
6
Table
1.
Registered
lindane
manufacturing­
use
products.

Formulation
EPA
Registry
Number
Registrant
99.5%
T
655­
28
1
Prentiss
Incorporated
99.5%
T
655­
393
1
99.5%
T
5481­
225
1
Amvac
Chemical
Corporation
99.5%
T
19713­
61
1
Drexel
Chemical
Company
99.5%
T
19713­
191
1
99.5%
T
40083­
1
Inquinosa
Internacional,
S.
A.

99.5%
T
66951­
1
Kanoria
Chemicals
&
Industries
Ltd.
99.5%
T
66951­
2
1
Repackaged
from
an
EPA­
registered
product.

REGULATORY
BACKGROUND
The
Lindane
Reregistration
Standard
and
the
Addendum
to
the
Lindane
Reregistration
Standard
were
issued
6/
7/
85
and
7/
16/
85,
respectively,
and
required
additional
product
chemistry
data
concerning
lindane.
The
Lindane
Guidance
Document
dated
9/
85
reiterated
the
data
gaps
outlined
under
the
Addendum
to
the
Reregistration
Standard.
Data
submitted
in
response
to
the
Guidance
Document
for
the
lindane
T/
TGAIs
were
evaluated
in
the
Lindane
Reregistration
Standard
Update
dated
1/
31/
91
with
regard
to
adequacy
in
fulfilling
product
chemistry
requirements.
The
Centre
International
d'Etudes
du
Lindane
(CIEL)
members
(Rhone­
Poulenc,
Inc.,
EM
Industries,
Inc.
(representing
Celamerck
GmbH
and
Company),
and
Inquinosa)
have
submitted
data
jointly.
Kanoria
Chemicals
and
Industries,
Inc.
became
a
member
of
CIEL
in
1994
(Letter
from
McKenna
and
Cuneo
on
behalf
of
CIEL
dated
11/
30/
94,
in
support
of
application
to
register
a
technical
lindane
product).
Prentiss
and
Amvac
previously
entered
into
data
sharing
agreements
with
CIEL
in
accordance
with
the
provisions
of
FIFRA
§3(
C)(
2)(
B)(
ii).
Technical
products
registered
to
Kanoria
Chemicals
&
Industries
were
suspended
effective
12/
5/
00
for
failure
to
comply
with
a
cost
sharing
agreement
with
Inquinosa.

The
current
status
of
the
product
chemistry
data
requirements
for
the
lindane
T/
TGAIs
is
presented
in
the
attached
data
summary
tables.
Refer
to
these
tables
for
a
listing
of
the
outstanding
product
chemistry
data
requirements.

CONCLUSIONS
Pertinent
product
chemistry
data
remain
outstanding
for
the
Inquinosa
99.5%
T/
TGAI
concerning
product
identity,
starting
materials
and
production
process,
preliminary
analysis,
certified
limits,
oxidation/
reduction,
explodability,
storage
stability,
corrosion
characteristics,
and
UV/
visible
absorption
(OPPTS
830.1550,
1600,
1620,
1700,
1750,
6314,
6316,
6317,
6320,
and
7050).
7
Technical
products
registered
to
Kanoria
Chemicals
&
Industries
were
suspended
effective
12/
5/
00
for
failure
to
comply
with
a
cost
sharing
agreement
with
Inquinosa.
Therefore,
all
technical
registered
which
are
repackages
of
the
Kanoria
products
would
be
required
to
change
suppliers.
The
Kanoria
products
are
shown
in
attached
data
summary
tables
for
informational
purposes
only.
The
Prentiss,
Drexel,
and
Amvac
99.5%
Ts
are
repackaged
from
EPA­
registered
products,
and
all
data
requirements
will
be
satisfied
by
data
for
the
technical
source
products.
Provided
that
the
registrants
submit
the
data
required
in
the
attached
data
summary
tables
for
the
lindane
T/
TGAIs,
and
either
certify
that
the
suppliers
of
beginning
materials
and
the
manufacturing
processes
have
not
changed
since
the
last
comprehensive
product
chemistry
reviews
or
submit
complete
updated
product
chemistry
data
packages,
HED
has
no
objections
to
the
reregistration
of
lindane
with
respect
to
product
chemistry
data
requirements.

AGENCY
MEMORANDA
CITED
IN
THIS
DOCUMENT
DP
Barcode:
D211047
Subject:
RD
Product
Chemistry
Review
for
EPA
File
Symbol
Number
66951­
R,
Kanoria
Lindane
Crystals
From:
S.
Mathur
To:
G.
Larocca
Dated:
3/
21/
95
MRID(
s):
43498201­
43498203
DP
Barcode:
D211063
Subject:
RD
Product
Chemistry
Review
for
EPA
File
Symbol
Number
66951­
E,
Kanoria
Lindane
Powder
From:
S.
Mathur
To:
G.
Larocca
Dated:
3/
21/
95
MRID(
s):
43498201­
43498203
PRODUCT
CHEMISTRY
CITATIONS
Bibliographic
citations
include
only
MRIDs
containing
data
which
fulfill
data
requirements.

References
(cited):

00072468
Hooker
Chemical
&
Plastics
Corporation
(19??)
Product
Chemistry
Data:
Lindane
HGI.
(Unpublished
study
received
May
7,
1981
under
935­
17;
CDL:
245029­
A)

00102995
Zoecon
Corp.
(1981)
[Study
of
the
Chemical
Lindane].
(Compilation;
unpublished
study
received
Sep
15,
1981
under
20954­
107;
CDL:
246026­
A)

00118712
Commerce
Industrial
Chemicals,
Inc.
(1969)
Laboratory
Report:
[Lindane]:
Lab
No.
C11,131,
Supplement
#1.
(Unpublished
study
received
May
12,
1969
under
10531­
1;
submitted
by
Petland
Products,
Inc.,
Chicago,
IL;
CDL:
026276­
A)
8
00118743
Makhteshim
Beer­
Sheva
Chemical
Works,
Ltd.
(1976)
[Chemistry
of
Lindane].
(Compilation;
unpublished
study
received
Jul
11,
1978
under
11678­
16;
CDL:
234441­
A)

00160127
Inquinosa
(19??)
Synthesis
of
Lindane.
Unpublished
study.
4
p.

00160129
Buys,
M.
(1986)
Lindane...
Product
Identity
and
Composition...
Discussion
of
the
Formation
of
Impurities:
Report
AG/
CRLD/
AN/
MB/
ID/
15274.86.
Unpublished
study
prepared
by
Rhone­
Poulenc
Agrochimie.
10
p.

00160130
Mirfakhrae,
K.;
Norris,
F.
(1986)
Determination
of
the
Octanol/
Water
Partition
Coefficient
of
Lindane:
Ref.
No.
86/
BHL/
191/
AG:
ASD
No.
86/
187.
Unpublished
study
prepared
by
Rhone­
Poulenc
Inc.
26
p.

00164782
Viziere,
G.
(1986)
Lindane:
Analysis
and
Certification
of
Product
Ingredients:
AG/
CRLD/
AN/
MB/
ID/
15871.86.
Unpublished
study
prepared
by
Rhone­
Poulenc
Agrochimie.
57
p.

00164783
Buys,
M.
(1986)
Lindane:
Analytical
Data
for
the
Technical
Grade
Lindane
Produced
by
Inquinosa:
Report
AG/
CRLD/
AN/
MB/
ID/
158874.86.
Unpublished
study
prepared
by
Rhone­
Poulenc
Agrochimie.
9
p.

43498201
Brookman,
D.;
Curry,
K.
(1994)
The
Product
Chemistry
of
Kanoria
Lindane
(Product
Identity
and
Disclosure
of
Ingredients).
Unpublished
study
prepared
by
Technology
Sciences
Group,
Inc.
35
p.

43498202
Brookman,
D.;
Curry,
K.
(1994)
The
Product
Chemistry
of
Kanoria
Lindane
(Analysis
and
Certification
of
Product
Ingredients).
Unpublished
study
prepared
by
Technology
Sciences
Group,
Inc.
49
p.

43498203
Brookman,
D.;
Curry,
K.
(1994)
The
Product
Chemistry
of
Kanoria
Lindane
(Physical
and
Chemical
Characteristics).
Unpublished
study
prepared
by
Technology
Sciences
Group,
Inc.
18
p.
9
Case
No.
0315
PC
Code:
009001
Case
Name:
Lindane
Registrant:
Prentiss,
Inc.
Product(
s):
99.5%
Ts
(EPA
Reg.
Nos.
655­
28
and
655­
393)

PRODUCT
CHEMISTRY
DATA
SUMMARY
Guideline
Number
Requirement
Are
Data
Requirements
Fulfilled?
1
MRID
Number
2
830.1550
Product
identity
and
composition
Y
CSF
4/
21/
97
(655­
28)
CSF
4/
23/
97
(655­
393)
830.1600
Description
of
materials
used
to
produce
the
product
N/
A
830.1620
Description
of
production
process
N/
A
830.1670
Discussion
of
formation
of
impurities
N/
A
830.1700
Preliminary
analysis
N/
A
830.1750
Certified
limits
Y
CSF
4/
21/
97
(655­
28)
CSF
4/
23/
97
(655­
393)
830.1800
Enforcement
analytical
method
N/
A
830.6302
Color
N/
A
830.6303
Physical
state
N/
A
830.6304
Odor
N/
A
830.6313
Stability
to
normal
and
elevated
temperatures,
metals,
and
metal
ions
N/
A
830.6314
Oxidation/
reduction:
chemical
incompatability
N/
A
830.6315
Flammability
N/
A
830.6316
Explodability
N/
A
830.6317
Storage
stability
N/
A
830.6319
Miscibility
N/
A
830.6320
Corrosion
characteristics
N/
A
830.7000
pH
N/
A
830.7050
UV/
visible
absorption
N/
A
830.7100
Viscosity
N/
A
830.7200
Melting
point/
melting
range
N/
A
830.7220
Boiling
point/
boiling
range
N/
A
830.7300
Density/
relative
density/
bulk
density
N/
A
830.7370
Dissociation
constants
in
water
N/
A
830.7550
Partition
coefficient
(n­
octanol/
water),
shake
flask
method
N/
A
830.7840
Water
solubility:
column
elution
method;
shake
flask
method
N/
A
830.7950
Vapor
pressure
N/
A
1
Y
=
Yes;
N
=
No;
N/
A
=
Not
Applicable.
The
Prentiss
technical
products
are
repackaged
from
EPA­
registered
products;
data
requirements
will
be
satisfied
by
data
for
the
source
products.

2
The
CSFs
were
obtained
from
the
product
jackets.
10
Case
No.
0315
PC
Code:
009001
Case
Name:
Lindane
Registrant:
Amvac
Chemical
Corp.
Product(
s):
99.5%
T
(EPA
Reg.
No.
5481­
225)

PRODUCT
CHEMISTRY
DATA
SUMMARY
Guideline
Number
Requirement
Are
Data
Requirements
Fulfilled?
1
MRID
Number
2
830.1550
Product
identity
and
composition
N
3
CSF
6/
19/
86
830.1600
Description
of
materials
used
to
produce
the
product
N/
A
830.1620
Description
of
production
process
N/
A
830.1670
Discussion
of
formation
of
impurities
N/
A
830.1700
Preliminary
analysis
N/
A
830.1750
Certified
limits
N
3
CSF
6/
19/
86
830.1800
Enforcement
analytical
method
N/
A
830.6302
Color
N/
A
830.6303
Physical
state
N/
A
830.6304
Odor
N/
A
830.6313
Stability
to
normal
and
elevated
temperatures,
metals,
and
metal
ions
N/
A
830.6314
Oxidation/
reduction:
chemical
incompatability
N/
A
830.6315
Flammability
N/
A
830.6316
Explodability
N/
A
830.6317
Storage
stability
N/
A
830.6319
Miscibility
N/
A
830.6320
Corrosion
characteristics
N/
A
830.7000
pH
N/
A
830.7050
UV/
visible
absorption
N/
A
830.7100
Viscosity
N/
A
830.7200
Melting
point/
melting
range
N/
A
830.7220
Boiling
point/
boiling
range
N/
A
830.7300
Density/
relative
density/
bulk
density
N/
A
830.7370
Dissociation
constants
in
water
N/
A
830.7550
Partition
coefficient
(n­
octanol/
water),
shake
flask
method
N/
A
830.7840
Water
solubility:
column
elution
method;
shake
flask
method
N/
A
830.7950
Vapor
pressure
N/
A
1
Y
=
Yes;
N
=
No;
N/
A
=
Not
Applicable.
The
available
CSF
indicates
that
the
Amvac
technical
product
is
repackaged
from
EPA­
registered
products
which
have
been
canceled
(1/
28/
98).
If
the
product
is
repackaged
from
a
currently
registered
product,
data
requirements
will
be
satisfied
by
data
for
the
source
product;
otherwise,
additional
product
chemistry
data
may
be
required.

2
The
CSF
was
reviewed
in
the
Lindane
Reregistration
Standard
Update
dated
1/
31/
91.

3
The
CSF
must
be
revised
to
cite
the
current
registered
source(
s)
of
the
technical
product
(PPIS
Deficiency
Notice,
11/
1/
99,
J.
Hinkle).
11
Case
No.
0315
PC
Code:
009001
Case
Name:
Lindane
Registrant:
Drexel
Chemical
Company
Product(
s):
99.5%
Ts
(EPA
Reg.
Nos.
19713­
61
and
19713­
191)

PRODUCT
CHEMISTRY
DATA
SUMMARY
Guideline
Number
Requirement
Are
Data
Requirements
Fulfilled?
1
MRID
Number
2
830.1550
Product
identity
and
composition
Y
CSFs
2/
25/
98
830.1600
Description
of
materials
used
to
produce
the
product
N/
A
830.1620
Description
of
production
process
N/
A
830.1670
Discussion
of
formation
of
impurities
N/
A
830.1700
Preliminary
analysis
N/
A
830.1750
Certified
limits
Y
3
CSFs
2/
25/
98
830.1800
Enforcement
analytical
method
N/
A
830.6302
Color
N/
A
830.6303
Physical
state
N/
A
830.6304
Odor
N/
A
830.6313
Stability
to
normal
and
elevated
temperatures,
metals,
and
metal
ions
N/
A
830.6314
Oxidation/
reduction:
chemical
incompatability
N/
A
830.6315
Flammability
N/
A
830.6316
Explodability
N/
A
830.6317
Storage
stability
N/
A
830.6319
Miscibility
N/
A
830.6320
Corrosion
characteristics
N/
A
830.7000
pH
N/
A
830.7050
UV/
visible
absorption
N/
A
830.7100
Viscosity
N/
A
830.7200
Melting
point/
melting
range
N/
A
830.7220
Boiling
point/
boiling
range
N/
A
830.7300
Density/
relative
density/
bulk
density
N/
A
830.7370
Dissociation
constants
in
water
N/
A
830.7550
Partition
coefficient
(n­
octanol/
water),
shake
flask
method
N/
A
830.7840
Water
solubility:
column
elution
method;
shake
flask
method
N/
A
830.7950
Vapor
pressure
N/
A
1
Y
=
Yes;
N
=
No;
N/
A
=
Not
Applicable.
The
Drexel
technical
products
are
repackaged
from
EPA­
registered
products;
data
requirements
will
be
satisfied
by
data
for
the
source
products.
Data
previously
submitted
by
Drexel
in
support
of
the
reregistration
of
these
products
are
no
longer
applicable.

2
The
CSFs
were
obtained
from
the
product
jackets.

3
The
CSFs
should
be
revised
to
propose
certified
limits
for
the
active
ingredient
which
reflect
the
actual
levels
in
the
technical
products.
12
Case
No.
0315
PC
Code:
009001
Case
Name:
Lindane
Registrant:
Inquinosa
Internacional,
S.
A.
Product(
s):
99.5%
Ts
(EPA
Reg.
No.
40083­
1)

PRODUCT
CHEMISTRY
DATA
SUMMARY
Guideline
Number
Requirement
Are
Data
Requirements
Fulfilled?
1
MRID
Number
2
830.1550
Product
identity
and
composition
N
3
830.1600
Description
of
materials
used
to
produce
the
product
N
4
00160127
830.1620
Description
of
production
process
N
5
00160127
830.1670
Discussion
of
formation
of
impurities
Y
00160129
830.1700
Preliminary
analysis
N
6
00164783
830.1750
Certified
limits
N
3
830.1800
Enforcement
analytical
method
Y
7
00164782
830.6302
Color
Y
00072468
830.6303
Physical
state
Y
00118743
830.6304
Odor
Y
00102995
830.6313
Stability
to
normal
and
elevated
temperatures,
metals,
and
metal
ions
Y
00072468
830.6314
Oxidation/
reduction:
chemical
incompatability
N
830.6315
Flammability
N/
A
8
830.6316
Explodability
N
830.6317
Storage
stability
N
830.6319
Miscibility
N/
A
8
830.6320
Corrosion
characteristics
N
830.7000
pH
N/
A
9
830.7050
UV/
visible
absorption
N
10
830.7100
Viscosity
N/
A
8
830.7200
Melting
point/
melting
range
Y
00118743
830.7220
Boiling
point/
boiling
range
N/
A
8
830.7300
Density/
relative
density/
bulk
density
Y
00072468
830.7370
Dissociation
constants
in
water
N/
A
9
830.7550
Partition
coefficient
(n­
octanol/
water),
shake
flask
method
Y
00160130
830.7840
Water
solubility:
column
elution
method;
shake
flask
method
Y
00118712
830.7950
Vapor
pressure
Y
00118743
1
Y
=
Yes;
N
=
No;
N/
A
=
Not
Applicable.
A
CSF
for
the
Inquinosa
technical
product
was
not
available
from
the
product
jacket.
Until
a
current
CSF
is
available
for
comparison,
the
Agency
cannot
ascertain
whether
TGAI
data
(physical/
chemical
data)
from
other
CIEL
members
are
applicable
to
the
Inquinosa
product.

2
Bolded
references
were
reviewed
in
the
Lindane
Reregistration
Standard
dated
6/
7/
85
and
all
other
references
were
reviewed
in
the
Lindane
Reregistration
Standard
Update
dated
1/
31/
91.

3
An
updated
CSF
is
required
for
evaluation
of
the
product
chemistry
data
(Lindane
Reregistration
Standard
Update
dated
1/
31/
91).
13
4
Information
is
required
concerning
the
relative
amounts
and
order
in
which
the
starting
materials
are
added.

5
Additional
information
is
required
concerning:
(I)
clarification
as
to
whether
the
process
is
a
batch
or
continuous
process;
(ii)
the
duration
of
each
step
and
the
entire
process;
(iii)
description
of
the
equipment
used;
and
(iv)
quality
control
measures
used
to
ensure
the
integrity
of
the
product.

6
Data
demonstrating
that
the
method
used
for
analysis
of
dioxins
and
dibenzofurans
can
quantitate
the
2,
3,
7,
8TCDD
reference
standard
to
0.
1
ppb
must
be
provided.

7
If
the
CIPAC
normalized
4
gamma/
1/
M/
1
cryoscopic
method
is
to
be
used
for
enforcement
of
certified
limits
of
the
active
ingredient,
then
a
complete
description
of
the
method,
along
with
supporting
validation
data,
is
required.

8
Data
are
not
required
because
the
TGAI/
MP
is
a
solid
at
room
temperature.

9
Data
were
not
required
by
the
Lindane
Registration
Standard
concerning
pH
and
dissociation
constant.

10
The
OPPTS
Series
830,
Product
Properties
Test
Guidelines
require
data
pertaining
to
UV/
visible
absorption
for
the
PAI.
14
LINDANE
Case
0315;
PC
Code
009001
D279259
Reregistration
Eligibility
Decision
Residue
Chemistry
Considerations
December
11,
2001
Contract
No.
68­
W­
99­
053
Submitted
to:
U.
S.
Environmental
Protection
Agency
Arlington,
VA
Submitted
by:
Dynamac
Corporation
The
Dynamac
Building
2275
Research
Boulevard
Rockville,
MD
20850­
3268
15
LINDANE
REREGISTRATION
ELIGIBILITY
DECISION
RESIDUE
CHEMISTRY
CONSIDERATIONS
Case
0315;
PC
Code
009001
TABLE
OF
CONTENTS
page
INTRODUCTION
.........................................................
16
REGULATORY
BACKGROUND
.............................................
16
SUMMARYOFSCIENCE
FINDINGS
.........................................
17
GLN
860.1200:
Directions
for
Use
........................................
17
GLN
860.1300:
Nature
of
the
Residue
­
Plants
...............................
18
GLN
860.1300:
Nature
of
the
Residue
­
Animals
..............................
18
GLN
860.1340:
Residue
Analytical
Methods
.................................
19
GLN
860.1360:
Multiresidue
Methods
.....................................
20
GLN
860.1380:
Storage
Stability
Data
.....................................
21
GLN
860.1500:
Crop
Field
Trials
.........................................
21
GLN
860.1520:
Processed
Food/
Feed
......................................
23
GLN
860.1480:
Meat,
Milk,
Poultry,
Eggs
..................................
23
GLN
860.1400:
Water,
Fish,
and
Irrigated
Crops
.............................
26
GLN
860.1460:
Food
Handling
...........................................
26
GLN
860.1850
and
860.1900:
Confined/
Field
Accumulation
in
Rotational
Crops
.....
26
TOLERANCE
REASSESSMENT
SUMMARY
...................................
39
Tolerances
Listed
Under
40
CFR
§180.133
..................................
39
Tolerances
To
Be
Proposed
Under
40
CFR
§180.133
...........................
40
PendingTolerancePetitions
..............................................
40
CODEXHARMONIZATION.................................................
43
DIETARYEXPOSUREASSESSMENT
........................................
45
AGENCYMEMORANDARELEVANTTOREREGISTRATION
....................
46
MASTERRECORDIDENTIFICATIONNUMBERS
..............................
50
16
Cl
Cl
Cl
Cl
Cl
Cl
LINDANE
REREGISTRATION
ELIGIBILITY
DECISION
RESIDUE
CHEMISTRY
CONSIDERATIONS
Case
0315;
PC
Code
009001
INTRODUCTION
Lindane
(gamma
isomer
of
benzene
hexachloride,
gamma
isomer
of
hexachlorocyclohexane)
is
a
broad
spectrum
organochlorine
insecticide/
acaricide
registered
for
control
of
insects
and
other
invertebrates
on
a
wide
variety
of
field
crops
and
vegetable
crops
(seed
treatment
only).
According
to
a
REFS
search,
conducted
on
5/
29/
01,
there
are
approximately
34
federally
registered
end­
use
products
(EPs)
containing
lindane
as
the
active
ingredient
and
three
Section
24C
registrations.
Lindane
end­
use
products
are
formulated
as
dust
(D),
wettable
powder
(WP),
emulsifiable
concentrate
(EC),
flowable
concentrate
(FlC),
and
ready­
to­
use
(RTU)
solution.

The
reregistration
of
lindane
is
being
supported
by
Centre
International
d'Etudes
du
Lindane
(CIEL)
and
its
member
company
holding
U.
S.
registrations,
Inquinosa,
S.
A.
Currently,
Inquinosa
does
not
have
any
registered
lindane
end­
use
products.
In
1993,
CIEL
offered
to
voluntarily
cancel
all
crop
uses
of
lindane
except
seed
treatment
and
certain
non­
food
uses.
The
Agency
considers
lindane
seed
treatment
as
a
food
use
requiring
tolerances
based
on
existing
data
from
radiolabeled
studies
indicating
uptake
of
residues
from
the
treated
seeds
into
the
aerial
portion
of
the
growing
crop.

REGULATORY
BACKGROUND
Lindane
is
a
List
A
reregistration
pesticide.
A
Reregistration
Standard
for
Lindane
was
issued
9/
85.
The
Residue
Chemistry
Chapter
to
the
Reregistration
Standard
was
issued
on
6/
7/
85,
an
addendum
on
9/
5/
85,
and
an
Update
on
1/
31/
91.
The
Reregistration
Standard
along
with
its
Science
Chapters
summarized
the
available
data
for
each
residue
chemistry
guideline
and
specified
what
additional
data
are
required
for
reregistration
purposes.
Data
Call­
In
(DCI)
Notices
for
lindane
were
issued
by
the
Agency
on
9/
30/
91,
3/
3/
95,
10/
13/
95,
and
3/
31/
97.
The
information
contained
in
this
document
outlines
the
current
Residue
Chemistry
Science
Assessments
with
respect
to
supporting
seed
treatment
uses
of
lindane,
as
well
as
the
reregistration
of
the
pesticide.
17
In
1983,
EPA
concluded
a
major
Special
Review
effort
of
lindane
based
on
carcinogenicity,
fetotoxicity/
teratogenicity,
reproductive
effects,
and
acute
effects
on
aquatic
organisms.
This
effort
resulted
in
the
cancellation
of
indoor
uses
of
smoke
fumigation
devices
and
greatly
limited
the
use
of
pet
dips
on
dogs.
In
addition,
there
were
uses
that
were
allowed
to
continue
only
if
certain
imposed
restrictions
were
implemented.
The
restrictions
were
based
on
the
degree
of
associated
hazards,
and
included
changes
in
warning
labels,
the
wearing
of
protective
clothing,
and
restrictions
to
limit
uses
to
certified
pest
control
operators.

In
1995,
EPA
announced
(FR
Vol.
60,
No.
143,
38329­
38331,
7/
26/
95)
its
decision
not
to
initiate
a
Special
Review
of
lindane
based
on
worker
health
concerns
arising
from
studies
showing
irreversible
renal
effects
in
the
rat.
The
Agency
has
determined
that
these
effects
occur
only
in
the
kidneys
of
male
rat
and
are
not
relevant
for
human
risk
assessment.

Tolerances
are
currently
established
under
40
CFR
§180.133
for
residues
of
lindane
per
se
in/
on
various
raw
agricultural
commodities
at
0.01
ppm
(pecans)
to
3
ppm
(cucumbers,
lettuce,
melons,
mushrooms,
pumpkins,
squash,
summer
squash,
and
tomatoes).
Lindane
tolerances
are
also
established
at
4
ppm
in
the
fat
of
meat
from
hogs
and
at
7
ppm
in
the
fat
of
meat
from
cattle,
goats,
horses,
and
sheep.
No
tolerances
have
been
established
for
processed
food/
feed
commodities.
Adequate
methods
are
available
for
the
enforcement
of
tolerances
for
residues
of
lindane
per
se
in/
on
plant
and
animal
commodities.

SUMMARY
OF
SCIENCE
FINDINGS
GLN
860.1200:
Directions
for
Use
The
basic
registrants,
CIEL
and
its
member
company
(Inquinosa)
presently
do
not
have
any
registered
lindane
end­
use
products.
However,
it
is
noted
that
lindane
remains
registered
by
other
companies
for
use
on
a
wide
variety
of
food/
feed
crops
such
as
fruit
crops,
field
crops,
and
vegetable
crops
(including
seed
treatment)
[Source:
5/
29/
01
search
of
EPA's
REFS
database].
CIEL
and
its
member
company
have
expressed
intentions
to
support
certain
non­
food
uses
and
seed
treatment
uses
of
lindane
on
cereal
grains
(including
barley,
corn,
oats,
rye,
sorghum,
and
wheat
but
excluding
rice
and
wild
rice).

The
registrants
have
submitted
PP#
9F05057,
for
the
establishment
of
time­
limited
tolerances
for
residues
of
lindane
per
se
in/
on
the
RACs
of
crops
for
which
seed
treatments
are
being
proposed.
Tolerances
cannot
be
established
or
reassessed
until
an
adequate
plant
metabolism
study
is
submitted.

The
registrants
have
also
submitted
PP#
9F6022,
for
the
establishment
of
tolerances
on
lindane
per
se
in/
on
canola
for
which
seed
treatment
is
being
proposed.
Tolerances
cannot
be
established
or
reassessed
until
an
adequate
plant
metabolism
study
is
submitted
and
additional
residue
data.

A
tabular
summary
of
the
residue
chemistry
science
assessments
for
reregistration
of
lindane
is
presented
in
Table
A.
When
end­
use
product
DCIs
are
developed
(e.
g.,
at
issuance
of
the
RED),
RD
should
require
that
all
end­
use
product
labels
(e.
g.,
MAI
labels,
SLNs,
and
products
subject
18
to
the
generic
data
exemption)
be
amended
such
that
they
are
consistent
with
the
residue
data
which
was
submitted.
A
30­
day
plantback
interval
for
leafy
vegetables
and
a
12­
month
plantback
interval
for
all
other
unregistered
crops
is
required
on
all
of
their
end­
use
product
labels
for
lindane.

GLN
860.1300:
Nature
of
the
Residue
­
Plants
The
qualitative
nature
of
lindane
residues
in
plants
reflecting
seed
treatment
is
inadequately
understood.
For
the
purpose
of
reregistration,
the
basic
registrants
are
required
to
conduct
a
new
plant
metabolism
study
on
lindane.
This
study
should
be
conducted
on
a
representative
cereal
grain,
as
the
registrants
have
indicated
that
the
only
food
uses
they
are
supporting
are
for
seed
treatment
of
these
crops.
The
new
studies
should
be
conducted
at
an
application
rate
which
will
insure
that
sufficient
14
C­
residues
are
available
for
analysis.
Crop
samples
should
be
harvested
at
the
appropriate
stage.
In
addition,
care
should
be
taken
to
insure
that
radioactivity
is
not
lost
during
analysis.
Identification
of
14
C­
residues
should
also
be
confirmed
using
more
than
one
method,
or
by
GC/
MS.

The
results
of
the
requested
plant
metabolism
study
will
be
considered
by
HED's
MARC
for
determination
of
terminal
residues
of
concern
in
cereal
grains.
Although
the
nature
of
the
residue
in
plants
remains
inadequately
understood
at
this
time,
HED
has
no
objection
to
proceeding
with
the
Lindane
RED
and
with
risk
assessments,
given
that
acceptable
enforcement
and
datacollection
methods
are
available
for
determining
residues
of
lindane
per
se
in/
on
plants
and
the
proposed
food/
feed
uses
of
lindane
are
limited
to
seed
treatment.
The
HED
MARC
(T.
Morton,
8/
30/
00,
D267069)
concluded
that
the
total
radioactive
residues
should
be
used
for
risk
assessment
purposes
until
adequate
plant
metabolism
studies
are
submitted.

Plant
metabolism
studies
reflecting
postemergence
foliar
application
on
apples
(MRID
40410902),
cucumbers
(MRID
40431204),
and
spinach
(MRID
40431201)
were
previously
submitted
by
the
basic
registrants
in
response
to
the
requirements
of
the
9/
85
Lindane
Reregistration
Guidance
Document.
These
studies
were
deemed
unacceptable
and
nonupgradable
because
of
several
deficiencies
including
inadequate
characterization
and
identification
of
14
C­
residues.

GLN
860.1300:
Nature
of
the
Residue
­
Animals
The
qualitative
nature
of
the
residue
in
ruminants
is
adequately
understood.
The
basic
registrants
had
submitted
a
ruminant
metabolism
study
(MRID
44867104)
which
was
deemed
inadequate
but
upgradable.
To
upgrade
the
study,
the
registrant
was
required
to
identify
the
metabolite
labeled
LiV
in
goat
liver's
aqueous
phase
which
accounted
for
25.2
%
of
the
total
radioactivity
(0.57
ppm).
In
addition,
storage
stability
data
was
required
showing
individual
tissue
sampling
dates
and
final
analysis
dates.
The
registrant
has
recently
submitted
the
required
data
(MRID
45224101,
45224102,
and
45277201)
thus,
adequately
addressing
this
deficiency.
A
brief
summary
of
the
recently
reviewed
goat
metabolism
study
follows.
Lactating
goats
were
orally
administered
with
[
14
C]
lindane
capsules
immediately
after
morning
milking
once
per
day
for
seven
19
days
at
a
level
equivalent
to
13
ppm.
Milk
was
collected
twice
daily
and
within
24
hours
of
the
last
dose,
the
animals
were
sacrificed.
The
total
radioactive
residues
(TRR;
expressed
as
lindane
equivalents)
in
collected
samples
were
3.
46
ppm
in
fat,
2.25
ppm
in
liver,
0.
48
ppm
in
kidney,
0.
20
ppm
in
muscle,
and
0.
20
ppm
in
milk.
The
parent,
lindane
was
the
major
residue
identified
in
all
goat
matrices
and
accounted
for
approximately
56%
of
the
TRR
in
milk
fat,
85%
of
the
TRR
in
fat,
81%
of
the
TRR
in
muscle,
36%
of
the
TRR
in
kidney,
and
16%
of
the
TRR
in
liver.
Other
metabolites
present
were:
gamma­
pentachlorocyclohexene
(PCCH);
1,2,4­
trichlorobenzene;
gamma­
tetrachlorocyclohexene
(TCCH);
1,2­
dichlorobenzene,
a
glutathione
conjugate
of
a
dichlorophenol,
and
a
conjugate
of
a
monochlorophenol.

The
qualitative
nature
of
the
residue
in
poultry
is
adequately
understood.
A
poultry
metabolism
study
(MRIDs
40271301
and
44405404),
submitted
by
the
registrants
in
response
to
the
9/
85
Lindane
Reregistration
Guidance
Document,
has
recently
been
upgraded
to
acceptable
status.
A
brief
summary
of
the
poultry
metabolism
study
follows.
Laying
hens
were
dosed
with
[
14
C]
lindane
at
levels
equivalent
to
1.2
ppm
or
120
ppm
in
the
diet
for
four
consecutive
days.
Radioactive
residues
accumulated
to
the
greatest
extent
in
fatty
tissues.
In
high
dose
hens,
TRR
levels
were
highest
in
fat
(96.98
ppm)
and
lowest
in
breast
muscle
(1.44
ppm).
TRR
levels
were
proportionally
less
in
tissues
of
low­
dose
hens
(fat,
1.
26
ppm;
breast
muscle
0.
02
ppm).
In
eggs
of
high­
dose
hens,
14
C­
residues
peaked
on
Day
4
at
10.83
ppm
in
yolks
and
0.21
ppm
in
whites.
Lindane
was
the
major
residue
component
identified
and
accounted
for
approximately
95%
of
the
TRR
in
egg
yolks,
71­
86%
of
the
TRR
in
muscle,
skin,
and
fat,
and
52%
of
the
TRR
in
liver.
Other
metabolites
that
were
identified
included:
1,2,4­
trichlorobenzene;
1,3,5­
trichlorobenzene
and
dichlorobenzene(
s);
tetrachlorobenzene
(either
1,2,4,5­
or
1,2,3,4­);
PCCH;
1,
2,
3,
4tetrachlorobenzene
tetrachlorocyclohexene;
1,2,3,4,5­
pentachlorobenzene;
and
hexachlorocyclohexene.

The
results
of
the
ruminant
and
poultry
metabolism
studies
will
be
presented
to
HED's
MARC
for
determination
of
terminal
residue
of
concern
in
eggs,
milk,
and
animal
tissues
when
an
acceptable
plant
metabolism
study
is
submitted.
If
the
Committee
determines
that
lindane
per
se
is
the
only
residue
of
concern
requiring
regulation,
then
the
existing
storage
stability
data
for
poultry
commodities,
the
analytical
method
used
for
data
collection,
and
the
poultry
feeding
study
will
be
upgraded
to
acceptable
status.

The
HED
MARC
(T.
Morton,
8/
30/
00,
D267069)
concluded
that
the
total
radioactive
residues
should
be
used
for
risk
assessment
purposes
until
an
adequate
plant
metabolism
study
is
submitted.

GLN
860.1340:
Residue
Analytical
Methods
Because
the
nature
of
the
residue
in
plants
resulting
from
seed
treatment
uses
have
not
been
adequately
delineated,
the
adequacy
of
the
available
analytical
methods
cannot
be
determined.
The
registrants
are
reminded
that
radiovalidation
of
enforcement
method(
s)
is
a
reregistration
requirement;
therefore,
representative
samples
from
the
requested
plant
metabolism
study
should
be
used
for
radiovalidation
and
analyzed
by
the
existing
or
proposed
enforcement
method(
s)
to
determine
whether
total
toxic
residues
are
extracted
from
weathered
samples.
20
Adequate
methods
are
available
for
determination
of
residues
of
lindane
per
se
in/
on
plant
and
animal
commodities.
The
Pesticide
Analytical
Manual
(PAM)
Vol.
II
lists
Methods
I
and
II
for
the
analysis
of
mixed
isomers
of
1,
2,
3,
4,
5,
6­
hexachlorocyclohexane
in/
on
plant
and
animal
commodities.
Method
I
is
a
multiresidue
method
(see
"GLN
860.1360:
Multiresidue
Methods"
section)
for
chlorinated
compounds.
Method
II
is
based
upon
the
official
final
AOAC
method
(1990,
15th
edition
of
AOAC)
and
is
suitable
for
determining
residues
of
lindane
in/
on
AOAC
Group
I
nonfatty
foods
(vegetables
and
fruits),
dairy
products,
fish,
and
eggs.
The
stated
limit
of
detection
of
Method
II
is
0.
05
ppm
for
most
commodities.

Adequate
data­
collection
methods
have
been
submitted
for
detection
of
lindane
per
se
in/
on
cucumbers
and
spinach.
The
analytical
procedures
for
detecting
lindane
in
cucumbers
and
spinach
are
essentially
the
same.
Residues
of
lindane
are
extracted
with
acetonitrile,
partitioned
with
hexane:
acetonitrile,
cleaned
up
using
Florisil
column
chromatography,
and
analyzed
by
gas
chromatography
with
electron
capture
detection
(ECD);
the
reported
detection
limit
was
0.01
ppm.
Based
on
acceptable
method
validation
recoveries,
the
Agency
has
deemed
the
GC/
ECD
method
to
be
adequate
for
determining
residues
of
lindane
per
se
in
nonfatty
crops.

A
GC/
MS
method
(SOP#
Meth­
109)
entitled
"Determination
of
Lindane
in
Wheat
and
Canola
Matrices"
was
utilized
as
the
data­
collection
method
in
a
recently
submitted
wheat
field
study.
Briefly,
residues
in/
on
wheat
forage,
hay,
grain,
and
straw
samples
were
extracted
with
acetonitrile
and
water.
The
water
was
salted
out,
and
an
aliquot
of
the
remaining
acetonitrile
extract
was
purified
by
means
of
a
hexane
solvent
partition,
gel
permeation
chromatography,
dichloromethane/
salt
water
solvent
partition,
and
a
carbon
black
solid
phase
extraction
cartridge
cleanup.
Detection
and
quantitation
were
conducted
using
a
gas
chromatograph
equipped
with
a
mass
selective
detector
(GC/
MS).
The
LOQ
was
0.
005
ppm.

A
data­
collection
method,
based
on
the
AOAC
method,
was
also
submitted
for
detection
of
lindane
per
se
in
eggs,
milk,
and
animal
tissues.
The
Agency
previously
required
an
EPA
method
validation
for
the
submitted
method
if
lindane
tolerances
for
lean
animal
tissues
were
to
be
established
because
the
AOAC
method
did
not
describe
techniques
which
the
registrant's
method
contained
(e.
g.,
gel
permeation
chromatography
and
rotary
evaporation).
The
FDA
method
now
utilizes
these
techniques;
therefore,
the
requirement
for
a
petition
method
validation
was
conditionally
waived
provided
HED's
MARC
determines
that
lindane
per
se
is
the
only
residue
of
concern
in
animal
commodities.

GLN
860.1360:
Multiresidue
Methods
The
10/
99
PESTDATA
database
(PAM,
Vol.
I,
Appendix
I)
contains
data
concerning
the
applicability
of
multiresidue
methods
to
lindane.
Lindane
is
completely
recovered
(>
80%
recovery)
using
protocols
302
(Luke
method),
303
(Mills,
Onley,
and
Gaither
method),
and
304
(Mills
method)
for
fatty
and
non­
fatty
foods.
Should
the
HED
MARC
determine
that
lindane
metabolites
other
than
the
parent
should
be
regulated,
the
Agency
will
require
the
registrants
to
submit
additional
multiresidue
methods
test
data
for
the
metabolites
of
concern.
21
GLN
860.1380:
Storage
Stability
Data
The
specifics
of
reregistration
requirements
for
storage
stability
data
in
plants
and
animals
cannot
be
ascertained
until
acceptable
plant
metabolism
studies
are
available,
and
the
HED
MARC
has
determined
the
terminal
residues
of
concern.
Assuming
that
lindane
per
se
is
the
terminal
residue
of
concern
and
provided
the
additional
temperature
information
is
submitted,
the
available
storage
stability
data
for
lindane
support
the
storage
conditions
and
intervals
of
samples
collected
from
existing
crop
field
trials
and
livestock
feeding
studies.
A
summary
of
available
storage
stability
data
for
lindane
per
se
is
summarized
below.

Raw
agricultural
and
processed
commodities:
Residues
of
lindane
per
se
are
relatively
stable
under
frozen
(­
20

C)
storage
conditions
for
up
to
8
months
in/
on
cucumbers
and
spinach
and
for
approximately
14
months
in/
on
tomatoes
and
wheat
forage.
Lindane
residues
are
stable
in
wheat
grain,
wheat
hay,
and
wheat
straw
for
up
to
approximately
18
months
when
stored
under
frozen
conditions.
Lindane
residues
in
canola
seed
were
stable
for
up
to
6.
5
months
when
stored
under
frozen
conditions
(no
temperature
given).
Lindane
residues
were
stable
for
up
to
2
months
in
canola
oil
and
1.
5
months
in
canola
meal
when
stored
under
frozen
conditions
(no
temperature
given).
The
registrant
is
required
to
submit
additional
storage
stability
data
(temperature
logs)
specifying
the
storage
conditions
of
the
canola
storage
stability
samples.
Assuming
that
lindane
per
se
is
the
terminal
residue
of
concern,
these
data
support
the
storage
conditions
and
intervals
of
samples
collected
from
existing
crop
field
trials.

Animal
commodities:
Residues
of
lindane
per
se
are
relatively
stable
in
eggs,
milk,
and
edible
tissues
of
animals
stored
frozen
(­
18

C)
for
up
to
9
months.
Assuming
that
lindane
per
se
is
the
terminal
residue
of
concern,
these
data
support
the
storage
conditions
and
intervals
of
samples
collected
from
existing
ruminant
and
poultry
feeding
studies.

GLN
860.1500:
Crop
Field
Trials
A
translocation
study
(MRID
40431207)
formed
the
basis
for
food­
use
classification
of
lindane
when
the
pesticide
is
applied
as
a
seed
treatment.
In
this
study,
[
14
C]
lindane
was
applied
as
a
seed
treatment
to
corn
(field
and
sweet),
mustard,
radish,
spinach,
sugar
beet,
and
wheat
at
approximately
1x
the
label
rate.
The
treated
seeds
were
then
planted
outdoors
in
55
gallon
drum
halves
and
allowed
to
grow
under
simulated
normal
agricultural
practices.
Samples
of
immature
and
mature
crop
commodities
were
analyzed
for
total
14
C,
and
some
fractions
were
extracted
with
hexane
and
analyzed
by
a
GC
method
for
total
lindane.
The
above
study
failed
to
adequately
identify
radioactive
residues
in/
on
all
commodities
grown
from
treated
seed.
Nonetheless,
with
the
possible
exception
of
wheat
grain
and
foliage,
residues
were
characterized
to
be
not
associated
with
biological
molecules
(e.
g.,
amino
acid,
sugar,
etc.)
that
have
incorporated
the
radiolabel.
The
total
residues
found,
the
hexane­
extractable
residues,
and
the
residues
attributable
to
lindane
are
summarized
in
the
table
below.
Should
the
HED
MARC
determine
that
lindane
metabolites
other
than
the
parent
should
be
regulated,
the
Agency
will
require
the
registrants
to
submit
additional
crop
field
trial
data
for
all
residues
of
concern.
22
Table
1.
Residues
in
Various
Crops
Grown
from
Seed
Treated
with
Lindane.

Crop
Matrix
TRR
(ppm)
Radioactivity
in
Hexane
Extract
Residues
Attributed
to
Lindane
Radish
Root
0.056
0.038
ppm;
68%
TRR
0.
030
ppm;
54%
TRR
Mustard
Foliage
0.021
0.012
ppm;
57%
TRR
0.
017
ppm;
81%
TRR
1
Field
Corn
Root
0.340
0.307
ppm;
90%
TRR
0.
165
ppm;
49%
TRR
Field
Corn
Foliage
0.064
0.016
ppm;
25%
TRR
0.
008
ppm;
13%
TRR
Field
Corn
Grain
<0.
01
­­


Sweet
Corn
Foliage
0.051
0.060
ppm;
118%
TRR
0.
012
ppm;
24%
TRR
Sweet
Corn
Grain
<0.01
­­


Sugar
Beet
Root
(Immature)
0.297
0.175
ppm;
59%
TRR
0.
090
ppm;
30%
TRR
Sugar
Beet
Foliage
0.181
0.174
ppm;
96%
TRR
0.
035
ppm;
19%
TRR
Wheat
Foliage
2.925
0.136
ppm;
4.
6%
TRR
0.016
ppm;
0.
55%
TRR
Wheat
Grain
0.052
­­
0.002
ppm;
3.
8%
TRR
Spinach
Leaves
0.
020
­­


1
Lindane
exceeds
the
TRR
of
extract.

The
registrants
have
submitted
PP#
9F05057,
for
the
establishment
of
time­
limited
tolerances
for
residues
of
lindane
per
se
in/
on
the
RACs
of
crops
for
which
seed
treatments
are
being
proposed.
Tolerances
cannot
be
established
or
reassessed
until
adequate
plant
metabolism
studies
are
submitted.

The
registrants
have
also
submitted
PP#
9F6022,
for
the
establishment
of
tolerances
on
lindane
per
se
in/
on
canola
for
which
seed
treatment
is
being
proposed.
Tolerances
cannot
be
established
or
reassessed
until
adequate
plant
metabolism
studies
are
submitted.

In
addition,
the
registrants
recently
submitted
acceptable
residue
data
reflecting
seed
treatment
on
wheat
RACs.
A
representative
formulation
(Lindane
30­
C)
was
applied
as
a
seed
treatment
to
wheat
at
0.52
oz.
ai/
cwt
(or
330
ppm
lindane
on
the
seed).
Following
treatment,
the
treated
seeds
were
planted
in
15
diverse
geographic
locations.
Wheat
forage
samples
were
collected
at
or
near
the
jointing
stage,
the
hay
samples
at
early
flower
to
soft
dough
stage,
and
the
grain
and
straw
samples
at
normal
harvest
maturity.
Residues
of
lindane
were
nondetectable
(<
0.
005
ppm)
in/
on
all
treated
wheat
grain
and
straw
samples.
Residues
of
lindane
ranged
from
<0.005
ppm
(nondetectable)
to
0.
04
ppm
in/
on
treated
wheat
forage
and
from
<0.005
ppm
(nondetectable)
to
0.02
ppm
in/
on
treated
wheat
hay.
Additional
residue
data
would
be
required
if
the
HED
MARC
determines
residues
of
concern
include
metabolites
of
lindane
in
addition
to
lindane
per
se.
23
GLN
860.1520:
Processed
Food/
Feed
No
data
are
available
to
determine
whether
lindane
residues
of
concern
concentrate
in
the
processed
fractions
of
corn
following
seed
treatment.
A
processing
study
on
corn
is
required
for
the
purpose
of
reregistration.
A
processing
study
on
wheat
would
also
be
required
if
the
HED
MARC
determines
residues
of
concern
include
metabolites
of
lindane
in
addition
to
lindane
per
se.

A
processing
study
for
wheat
processed
fractions
is
not
being
required
if
lindane
per
se
is
the
only
residue
of
concern
(S.
Funk,
10/
31/
95,
D213401).
In
1998,
the
U.
S.
Food
and
Drug
Administration
(FDA)
monitoring
program
analyzed
a
total
of
227
samples
of
milled
grain
products
for
lindane
residues
at
an
LOQ
of
0.01
ppm.
Commodities
analyzed
included
flour
and
other
milled
products,
breakfast
foods,
and
baked
goods.
Lindane
was
not
detected
in
any
sample.

The
registrant
submitted
a
canola
processing
study
along
with
PP#
9F6022
where
lindane
residues
in/
on
canola
refined
oil,
canola
meal,
and
bleached/
deodorized
canola
oil
were
determined.
Lindane
in
canola
refined
oil
concentrated
by
a
factor
of
at
least
5.
2x.
Lindane
did
not
concentrate
in
canola
meal
and
bleached/
deodorized
canola
oil.

GLN
860.1480:
Meat,
Milk,
Poultry,
Eggs
The
nature
of
the
residue
in
plants
is
not
understood.
Upon
receipt
of
the
requested
plant
metabolism
data,
the
Agency
will:
(I)
determine
the
adequacy
of
established
tolerances
for
animal
commodities;
(ii)
calculate
the
expected
dietary
intake
for
beef
cattle,
dairy
cattle,
and
swine;
and
(iii)
re­
evaluate
the
need
for
additional
feeding
studies.

It
should
be
noted
that
ruminant
(M.
Kovacs,
9/
20/
88,
CB
No.
4037)
and
poultry
feeding
(G.
Otakie,
8/
31/
88,
RCB
No.
4034)
studies
are
available
(summarized
below)
assuming
that
lindane
per
se
is
the
only
residue
of
concern
in
animals.

Ruminant
Feeding
Study
Thirteen
lactating
Holstein
cows
were
orally
administered
gelatin
capsules
containing
lindane
daily
for
28
consecutive
days.
The
cows
were
assigned
to
four
groups
(four
cows
per
dose
group
plus
one
control).
Three
of
the
four
cows
in
each
dosing
level
were
also
dermally
treated
via
a
dip
tank
on
day
21
and
28.
Lindane
residues
in
Table
2
are
from
the
single
cow
which
did
not
receive
the
dip
treatment.
Cows
were
housed
in
a
common
area.
The
administered
dose
levels
were
20
ppm,
60
ppm,
and
200
ppm
which
are
equivalent
to
143x,
426x,
and
1,418x
the
maximum
lindane
dietary
burden
of
0.
141
ppm
for
dairy
cattle
(assuming
lindane
is
the
sole
residue
of
concern).
Using
the
total
radioactive
residues
for
feed
items
as
required
by
the
HED
MARC,
the
feeding
levels
are
equivalent
to
3x,
10x,
and
34x
the
maximum
lindane
dietary
burden
for
dairy
cattle
(equivalent
to
7x,
20x,
and
67x
the
maximum
lindane
dietary
burden
for
beef
cattle).
The
calculation
of
expected
dietary
intake
for
beef
and
dairy
cattle,
using
feed
items
derived
from
proposed
seed
treatment
uses,
is
presented
in
Table
2.
The
daily
dose
was
given
to
each
cow
after
the
morning
milking.
Milk
subsamples
were
collected
for
analysis
on
days
0,
1,
3,
24
7,
14,
21,
25,
and
28.
Tissue
samples
were
collected
from
each
cow
after
sacrifice
by
exsanguination.

All
tissue
samples
were
immediately
frozen
on
dry
ice
and
stored
at
­15

C
for
4
to
4½
months
prior
to
residue
analysis.
Milk
samples
were
stored
at
­15

C
for
1
to
3
months
prior
to
analysis.
The
available
storage
stability
data
indicate
that
lindane
per
se
is
relatively
stable
in
eggs,
milk,
and
edible
tissues
of
animals
stored
frozen
(­
18

C)
for
up
to
9
months.
These
data
support
the
storage
conditions
and
intervals
of
samples
collected
from
dairy
cattle
feeding
study.
Samples
were
analyzed
for
lindane
residues
by
validated
AOAC
Multiresidue
GLC
methodology
with
electron
capture
detection.

Table
2.
Calculation
of
maximum
dietary
burdens
of
beef
cattle,
dairy
cattle,
and
swine
for
lindane
using
feed
items
derived
from
seed
treatment.

Feed
Commodity
%
Dry
Matter
%
Diet
Reassessed
Tolerance
(ppm)
2
Dietary
Contribution
(ppm)
1
Beef
Cattle
Corn
forage
40
40
0.1
0.
100
Corn
grain
88
60
0.
01
0.
007
Total
Burden
0.107
Dairy
Cattle
Corn
forage
40
50
0.1
0.
125
Corn
grain
88
40
0.
01
0.
004
Corn
stover
83
10
0.
1
0.012
Total
Burden
0.141
Swine
Corn
grain
NA
80
0.
01
0.
008
Wheat
grain
NA
20
0.005
0.001
Total
Burden
0.009
1
Contribution
=
[reassessed
tolerance
/
%
DM]
X
%
diet).

2
Reassessed
tolerance
if
lindane
per
se
is
determined
by
the
HED
MARC
to
be
the
only
residue
of
concern.

The
results
of
the
dairy
cattle
feeding
study
are
presented
in
Table
3.
There
appears
to
be
a
linear
correlation
between
the
dose
level
and
the
residue
found
for
each
tissue
and
for
milk.
Residues
of
lindane
in
milk
plateaued
on
Day­
7.
By
extrapolation
of
residue
levels
obtained
at
the
20­
ppm
dosing
levels,
the
maximum
expected
residues
of
lindane
in
dairy
cattle
milk
and
tissues
are
all
below
0.
01
ppm
except
in
the
fat
where
the
predicted
maximum
residue
is
0.084
ppm.
25
Table
3.
Residues
of
lindane
in
milk
and
meat
of
dairy
cattle
dosed
with
lindane
in
the
diet
at
20,
60
and
200
ppm
for
28
consecutive
days.

Tissue
Lindane
Residues
(ppm)
Obtained
at
Various
Dosing
Levels
20
ppm
60
ppm
200
ppm
Liver
0.
10
0.
19
0.
72
Kidney
0.34
1.07
4.57
Heart
1.
23
1.
56
10.
3
Muscle
0.97
1.80
8.75
Fat
11.9
20.2
158.1
Milk
Day­
7
0.
47
1.
08
5.
20
Day­
14
0.17
0.75
3.12
Day­
21
0.19
1.02
7.08
Day­
25
0.31
1.19
5.49
Day­
28
0.67
1.90
10.81
Poultry
Feeding
Study
Sixty
White
Leghorn
laying
hens
were
orally
administered
gelatin
capsules
containing
lindane
daily
for
28
consecutive
days.
The
hens
were
assigned
to
fourteen
groups
(four
hens
per
group,
4
groups
per
dose
level
plus
two
control
groups).
The
administered
dose
levels
were
1.
5
ppm,
4.
5
ppm,
and
15
ppm
which
are
equivalent
to
15x,
45x,
and
150x
the
maximum
lindane
dietary
burden
of
0.10
ppm
for
poultry
as
calculated
by
the
registrant.
The
daily
dose
was
given
to
each
hen
at
the
daily
egg
sampling
and
feeding.
Egg
samples
were
collected
for
analysis
on
days
0,
1,
3,
7,
14,
21,
25,
and
28.
Tissue
samples
were
collected
from
each
hen
after
sacrifice
by
exsanguination.
Tissue
samples
were
composited
by
group
(four
hens).

All
tissue
samples
were
immediately
frozen
on
dry
ice
and
stored
at
­15

C
for
a
maximum
of
5
months
prior
to
residue
analysis.
Egg
samples
were
stored
at
­15

C
for
a
maximum
of
5
months
prior
to
analysis.
The
available
storage
stability
data
indicate
that
lindane
per
se
is
relatively
stable
in
eggs,
milk,
and
edible
tissues
of
animals
stored
frozen
(­
18

C)
for
up
to
9
months.
These
data
support
the
storage
conditions
and
intervals
of
samples
collected
from
the
poultry
feeding
study.
Samples
were
analyzed
for
lindane
residues
by
validated
AOAC
Multiresidue
GLC
methodology
with
electron
capture
detection.

The
results
of
the
poultry
feeding
study
are
presented
in
Table
4.
There
appears
to
be
a
linear
correlation
between
the
dose
level
and
the
residue
found
for
eggs
and
each
tissue.
Residues
of
lindane
in
eggs
plateaued
by
Day­
14.
By
extrapolation
of
residue
levels
obtained
at
the
1.
5­
ppm
dosing
levels,
the
maximum
expected
residues
of
lindane
in
poultry
eggs
and
tissues
are
all
below
0.01
ppm
except
in
the
kidney,
fat,
and
eggs
where
the
predicted
maximum
residues
are
0.011,
0.169,
and
0.
014
ppm,
respectively.
26
Table
4.
Residues
of
lindane
in
eggs
and
tissues
of
laying
hens
dosed
with
lindane
in
the
diet
at
1.
5,
4.
5
and
15
ppm
for
28
consecutive
days.

Tissue
Lindane
Residues
(ppm)
Obtained
at
Various
Dosing
Levels
1.5
ppm
4.5
ppm
15
ppm
Liver
0.
12
0.
51
0.
78
Kidney
0.17
0.55
2.03
Heart
0.
33
0.
89
2.
26
Gizzard
0.
10
0.
32
0.
95
Thigh
0.
19
0.
36
1.
35
Breast
0.03
0.10
0.37
Fat
2.
54
7.
75
27.65
Eggs
Day­
7
0.
110
0.258
0.878
Day­
14
0.216
0.609
2.14
Day­
21
0.185
0.603
2.36
Day­
25
0.189
0.672
2.10
Day­
28
0.205
0.588
2.38
GLN
860.1400:
Water,
Fish,
and
Irrigated
Crops
Lindane
is
presently
not
registered
for
direct
use
on
water
and
aquatic
food
and
feed
crops;
therefore,
no
residue
chemistry
data
are
required
under
this
guideline
topic.

GLN
860.1460:
Food
Handling
Lindane
is
presently
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
The
basic
registrants
have
submitted
a
confined
rotational
crop
study
which
was
deemed
unacceptable
and
not
upgradable
because
of
inadequate
characterization
and
identification
of
residues
due
to
significant
losses
of
organosoluble
residues
during
analysis.
Although
the
study
is
inadequate
and
the
application
rate
used
(0.75
lb
ai/
A)
greatly
exceeds
the
level
of
soil
residues
that
are
likely
to
result
from
seed­
treatment
uses,
the
data
indicate
that
residues
of
lindane
persist
in
the
soil
and
can
be
taken
up
by
rotational
crops
at
intervals
up
to
one
year.

For
the
purpose
of
reregistration,
the
Agency
will
not
require
a
new
confined
rotational
crop
study
provided
the
registrants
propose
a
30­
day
plantback
interval
for
leafy
vegetables
and
a
12­
month
plantback
interval
for
all
other
unregistered
crops
on
all
of
their
end­
use
product
labels
for
lindane.
If
this
recommendation
is
not
acceptable
to
the
registrants,
then
limited
rotational
field
trial
data
are
required.
The
limited
field
trials
should
be
conducted
on
a
representative
crop
(as
defined
in
40
CFR
180.41)
at
two
sites
per
crop
for
the
following
three
crop
groups:
root
and
tuber
vegetables,
leafy
vegetables
and
small
grains
(wheat,
barley,
oats,
and
rye)
for
a
total
of
six
27
trials.
As
with
confined
studies
(OPPTS
860.1850),
soybeans
may
be
substituted
for
the
leafy
vegetable.
The
six
trials
should
be
conducted
on
crops
which
a
registrant
intends
to
have
as
rotational
crops
on
the
label.
In
addition,
some
of
the
six
trials
could
be
conducted
using
other
crops
that
are
typically
involved
in
crop
rotation
such
as
alfalfa
and
soybeans.
The
registrants
have
informed
the
Agency
they
will
propose
the
specified
plantback
intervals.

The
results
of
the
confined
rotational
crop
study
are
summarized
in
the
tables
below.

Table
5a.
Summary
of
the
characterization/
identification
of
radioactive
residues
in/
on
barley
forage
grown
in
sandy
loam
soil
treated
with
[
14
C]
lindane
at
0.
75
lb
ai/
A
(22x
the
seed
treated
barley
application
rate).

30­
DAT
Barley
Forage
(TRR
=
0.
0991
ppm)
121­
DAT
Barley
Forage
(TRR
=
0.
3939
ppm)
365­
DAT
Barley
Forage
(TRR
=
0.
1082
ppm)

Metabolite
%TRR
ppm
%TRR
ppm
%TRR
ppm
Identified
Lindane
15.79
0.0156
26.18
0.1031
3.17
0.0034
2,4­
Dichlorophenol
2.43
0.0024
1.02
0.0040
­­

2,4,5
Trichlorophenol
2.
96
0.
0029
2.89
0.0114
­­

2,3,4,6
Tetrachlorophenol
­­
­­
4.
45
0.
0175
­­

Total
identified
21.18
0.0209
34.54
0.1360
3.17
0.0034
Characterized
Unidentified
Residues
3.
65
0.
0036
0.05
0.0002
9.31
0.0101
Total
identified/
characterized
24.83
0.0245
34.59
0.1362
12.48
0.0135
Nonextractable
51.36
0.0509
39.30
0.1548
40.39
0.0437
Table
5b.
Summary
of
the
characterization/
identification
of
radioactive
residues
in/
on
barley
straw
and
grain
grown
in
sandy
loam
soil
treated
with
[
14
C]
lindane
at
0.
75
lb
ai/
A.

30­
DAT
Barley
Straw
(TRR
=
0.
3866
ppm)
121­
DAT
Barley
Straw
(TRR
=
0.
9341
ppm)
30­
DAT
Barley
Grain
(TRR
=
0.
0478
ppm)

Metabolite
%TRR
ppm
%TRR
ppm
%TRR
ppm
Identified
Lindane
0.
36
0.
0014
2.42
0.0226
­­

4
Chlorophenol
16.61
0.0642
0.90
0.0084
8.79
0.0042
2,4­
Dichlorophenol
3.80
0.0147
2.28
0.0213
2.09
0.0010
2,4,5­
Trichlorophenol
1.
82
0.
0070
1.06
0.0099
3.35
0.0016
Total
identified
22.59
0.0873
6.66
0.0622
14.23
0.0068
Characterized
Unidentified
Residues
2.
58
0.
0100
1.73
0.0161
­­

Acid
hydrolysate
­­
­­
7.
37
0.
0688
­­

Total
identified/
characterized
25.17
0.0973
15.76
0.1471
14.23
0.0068
Nonextractable
NR
NR
78.21
0.7306
NR
NR
NR
=
not
reported
28
Table
6a.
Summary
of
the
characterization/
identification
of
radioactive
residues
in/
on
mature
carrot
root
grown
in
sandy
loam
soil
treated
with
[
14
C]
lindane
at
0.
75
lb
ai/
A.

30­
DAT
Mature
Carrot
Root
(TRR
=
0.
4447
ppm)
121­
DAT
Mature
Carrot
Root
(TRR
=
0.
4081
ppm)
365­
DAT
Mature
Carrot
Root
(TRR
=
0.
3984
ppm)

Metabolite
%TRR
ppm
%TRR
ppm
%TRR
ppm
Identified
Lindane
47.65
0.2119
83.12
0.3392
88.78
0.3537
Pentachlorocyclohexene
­­
­­
5.61
0.0229
3.21
0.0128
Total
identified
47.65
0.2119
88.73
0.3621
91.99
0.3665
Characterized
Unidentified
Residues
2.
41
0.
0107
3.16
0.0129
2.81
0.0112
Total
identified/
characterized
50.06
0.2226
91.89
0.3750
94.80
0.3777
Nonextractable
1.03
0.0046
2.50
0.0102
0.90
0.0036
Table
6b.
Summary
of
the
characterization/
identification
of
radioactive
residues
in/
on
mature
carrot
tops
grown
in
sandy
loam
soil
treated
with
[
14
C]
lindane
at
0.
75
lb
ai/
A.

30­
DAT
Mature
Carrot
Tops
(TRR
=
0.
0916
ppm)
121­
DAT
Mature
Carrot
Tops
(TRR
=
0.
1857
ppm)
365­
DAT
Mature
Carrot
Tops
(TRR
=
0.
0637
ppm)

Metabolite
%TRR
ppm
%TRR
ppm
%TRR
ppm
Identified
Lindane
69.19
0.0634
91.12
0.1692
18.45
0.0118
Total
identified
69.19
0.0634
91.12
0.1692
18.45
0.0118
Characterized
Unidentified
Residues
14.44
0.0132
2.80
0.0052
37.28
0.0237
Total
identified/
characterized
83.63
0.0766
93.92
0.1744
55.73
0.0355
Nonextractable
13.21
0.0121
10.29
0.0191
29.04
0.0409
29
Table
7.
Summary
of
the
characterization/
identification
of
radioactive
residues
in/
on
immature
and
mature
lettuce
grown
in
sandy
loam
soil
treated
with
[
14
C]
lindane
at
0.
75
lb
ai/
A.
a
30­
DAT
Immature
Lettuce
(TRR
=
0.
0207
ppm)
121­
DAT
Immature
Lettuce
(TRR
=
0.
0419
ppm)
30­
DAT
Mature
Lettuce
(TRR
=
0.
0429
ppm)

Metabolite
%TRR
ppm
%TRR
ppm
%TRR
ppm
Identified
Lindane
137.57
0.0285
26.08
0.0109
42.80
0.0184
4­
Chlorophenol
­­
­­
­­
­­
7.56
0.0032
2,4,5­
Trichlorophenol
­­
­­
­­
­­
7.
02
0.
0030
2,3,4,6­
Tetrachlorophenol
­­
­­
­­
­­
4.
30
0.
0018
Total
identified
137.57
0.0285
26.08
0.0109
61.68
0.0264
Characterized
Unidentified
Residues
­­
­­
5.
66
0.
0024
5.45
0.0023
Total
identified/
characterized
137.57
0.0285
31.74
0.0133
67.13
0.0287
Nonextractable
32.37
0.0067
24.58
0.0103
35.20
0.0151
a
Organosoluble
14
C­
residues
were

0.01
ppm
from
365­
day
immature
lettuce
and
121­
and
365­
day
mature
lettuce
samples
and
were
not
further
characterized.
(continued;
footnotes
follow)
30
Table
A.
Residue
Chemistry
Science
Assessments
for
Reregistration
of
Lindane.

GLN:
Data
Requirements
Current
Tolerances,
ppm
[40
CFR
§180.133]
Must
Additional
Data
Be
Submitted?
References
1
860.1200:
Directions
for
Use
N/
A
=
Not
Applicable
Yes
2
REFS
search
of
5/
29/
01
860.1300:
Plant
Metabolism
N/
A
Yes
3
00025707,
00060143,
00060150,
00105413,
GS­
00010,
GS­
00012,
GS­
00013,
GS­
00019,
40410902
4
,
40431201
4
,
40431204
4
,
44383001
5
,
44383002
5
,
44405403
6
860.1300:
Animal
Metabolism
N/
A
No
7
GS­
00014,
GS­
00015,
GS­
00016,
40271301
8
,
40271302
9
,
44405404
6
,
44867104
10
,
45224101
11
,
45224102
11
,
45277201
11
860.1340:
Residue
Analytical
Methods
­
Plant
commodities
N/
A
Reserved
12
05006312,
GS­
00018,
40431202
13
,
40431206
13
,
44383003
5
,
44383004
5
,
44909901
14
­
Animal
commodities
N/
A
Reserved
12
00025690,
00032233,
00099909,
05002348,
05003005,
GS­
00017,
40431208
15
,
44440601
16
,
44867105
10
860.1360:
Multiresidue
Methods
N/
A
Reserved
17
860.1380:
Storage
Stability
Data
­
Plant
commodities
N/
A
Yes
18
40431203
19
,
40431205
19
,
41699701
20
,
44440602
16
,
44909901
14
­
Animal
commodities
N/
A
Reserved
21
40660502
22
,
44440603
16
,
44867106
10
Table
A
(continued).

GLN:
Data
Requirements
Current
Tolerances,
ppm
[40
CFR
§180.133]
Must
Additional
Data
Be
Submitted?
References
1
(continued;
footnotes
follow)
31
860.1500:
Crop
Field
Trials
[NOTE:
The
basic
registrants
are
supporting
only
seed
treatment
uses
of
lindane
on
cereal
grains
(including
barley,
corn,
oats,
rye,
sorghum,
and
wheat
but
excluding
rice
and
wild
rice).
The
rows
corresponding
to
these
crops
are
shaded.]

Root
and
Tuber
Vegetables
Group
­
Beet,
sugar,
root
None
established
No
23
40431207
24
­
Radish,
root
None
established
No
25
40431207
24
Leaves
of
Root
and
Tuber
Vegetables
Group
­
Beet,
sugar,
tops
(leaves)
None
established
No
23
40431207
24
­
Radish,
tops
(leaves)
None
established
No
25
40431207
24
Bulb
Vegetables
(Allium
spp.)
Group
­
Onions
(dry
bulb)
1
No
23
Leafy
Vegetables
(Except
Brassica
Vegetables)
Group
­
Celery
(seed
treatment)
1
No
23
­
Lettuce
(seed
treatment)
3
No
26
41289407
­
Spinach
(seed
treatment)
1
No
26
40431207
24
­
Swiss
chard
(seed
treatment)
1
No
23
Brassica
(Cole)
Leafy
Vegetables
Group
­
Broccoli
(seed
treatment)
1
No
27
­
Brussels
sprouts
(seed
treatment)
1
No
27
­
Cabbage
(seed
treatment)
1
No
27
41289403
­
Cauliflower
(seed
treatment)
1
No
27
Table
A
(continued).

GLN:
Data
Requirements
Current
Tolerances,
ppm
[40
CFR
§180.133]
Must
Additional
Data
Be
Submitted?
References
1
(continued;
footnotes
follow)
32
­
Collards
(seed
treatment)
1
No
23
­
Kale
(seed
treatment)
1
No
23
­
Kohlrabi
(seed
treatment)
1
No
23
­
Mustard
greens
(seed
treatment)
1
No
23
40431207
24
­
Rape
greens
(seed
treatment)
None
established
No
23
Fruiting
Vegetables
(Except
Cucurbits)
Group
­
Eggplant
1
No
23
­
Pepper
1
No
23
­Tomato
3
No
23
41699701
20
,
41861201
28
Cucurbit
Vegetables
Group
­
Cucumber
3
No
23
41289404
­Melons
3
No
23
­
Pumpkin
3
No
23
­
Squash
3
No
23
Pome
Fruits
Group
­
Apple
1
No
23
41289401
­Pear
1
No
23
­Quince
1
No
23
Stone
Fruits
Group
­
Apricot
1
No
23
Table
A
(continued).

GLN:
Data
Requirements
Current
Tolerances,
ppm
[40
CFR
§180.133]
Must
Additional
Data
Be
Submitted?
References
1
(continued;
footnotes
follow)
33
­
Cherry
1
No
23
­
Nectarine
1
No
23
­
Peach
1
No
23
41289408
­Plum(
freshprune)
1
No
23
Tree
Nuts
Group
­
Pecan
0.
01
No
23
41289601,
41421001
Cereal
Grains
Group
­
Barley
grain
(seed
treatment)
None
established
No
29
­
Corn
grain
(seed
treatment)
None
established
No
40431207
24
­
Oats
grain
(seed
treatment)
None
established
No
29
­
Rye
grain
(seed
treatment)
None
established
No
29
­
Sorghum
grain
(seed
treatment)
None
established
No
32
40431207
24
­
Wheat
grain
(seed
treatment)
None
established
No
29
40431207
24
,
44909901
14
­
Canola
grain
(seed
treatment)
None
established
Yes
30
44864401
31
,
45310501
31
Forage,
Fodder,
and
Straw
of
Cereal
Grains
Group
(Excluding
Rice
and
Wild
Rice)

­
Barley
hay
and
straw
(seed
treatment)
None
established
No
29
­
Corn
forage
and
stover
(seed
treatment)
None
established
No
40431207
24
­
Oats
forage,
hay,
and
straw
(seed
treatment)
None
established
No
29
­
Rye
forage
and
straw
(seed
treatment)
None
established
No
29
Table
A
(continued).

GLN:
Data
Requirements
Current
Tolerances,
ppm
[40
CFR
§180.133]
Must
Additional
Data
Be
Submitted?
References
1
(continued;
footnotes
follow)
34
­
Sorghum
forage
and
stover
(seed
treatment)
None
established
No
32
40431207
24
­
Wheat
forage,
hay,
and
straw
(seed
treatment)
None
established
No
29
40431207
24
,
44909901
14
­
Canola
forage,
hay,
and
straw
(seed
treatment)
None
established
Yes
30
44864401
31
,
45310501
31
Miscellaneous
Commodities
­
Asparagus
1
No
23
­
Avocado
1
No
23
­
Grape
1
No
23
41289405
­
Guava
1
No
23
­
Mango
1
No
23
­
Miscellaneous
crops
with
seed
treatments
only
None
established
No
23
40431207
24
­
Mushroom
3
No
23
­Okra
1
No
23
­
Pineapple
1
No
23
­
Strawberry
1
No
23
­
Tobacco
None
established
No
23
41289409
860.1520:
Processed
Food/
Feed
­
Apple
None
established
No
23
41289402
­
Canola
None
established
Yes
18
44864401
31
,
45310501
31
Table
A
(continued).

GLN:
Data
Requirements
Current
Tolerances,
ppm
[40
CFR
§180.133]
Must
Additional
Data
Be
Submitted?
References
1
35
1.
Bolded
references
were
reviewed
in
the
Residue
Chemistry
Chapter
to
the
Lindane
Reregistration
Standard
dated
6/
7/
85
and
its
9/
5/
85
addendum.
Italicized
references
were
reviewed
in
the
Lindane
Product
and
Residue
Chemistry
Reregistration
Standard
Updates
(CB
No.
6961,
1/
31/
91,
E.
Zager).
All
other
references
were
reviewed
as
noted.
The
basic
registrants
are
supporting
only
seed
treatment
uses
of
lindane
on
cereal
grains
(including
barley,
corn,
oats,
rye,
sorghum,
and
wheat
but
excluding
rice
and
wild
rice).
The
rows
corresponding
to
these
crops
are
shaded.

2.
The
registrants
must
submit
a
formal
petition
for
the
establishment
of
tolerances
for
all
appropriate
RACs
being
supported
for
seed
treatment
uses.
The
petition
should
include
all
requisite
petition
sections
including
a
Section
B
specifying
the
maximum
use
rate
(in
terms
of
oz
ai/
100
lb
of
seeds
or
cwt)
and
information
pertaining
to
recommended
seeding
rate
per
acre
should
be
included
in
order
to
allow
the
Agency
to
calculate
rates
in
terms
of
lb
ai/
A.
In
addition,
the
registrants
should
formally
request
the
cancellation
of
all
­
Cereal
grains
None
established
Yes
33
­
Grape
None
established
No
23
41289406
­
Tomato
None
established
No
23
41861202
28
860.1480:
Meat,
Milk,
Poultry,
Eggs
­
Milk,
Fat,
Meat,
and
Meat
Byproducts
of
Cattle,
Goats,
Hogs,
Horses,
and
Sheep
7(
fat
ofmeat
from
cattle,
goats,
horses,
and
sheep);
4(
fat
ofmeat
from
hogs)
Reserved
40
00025685,
00045126,
00075989,
00088048,
00088165,
00089592,
00101478,
00104441,
00118722,
00118723,
00118724,
00118725,
00118739,
GS­
00018,
GS­
00021,
GS­
00022,
GS­
00023,
40660503
34
,
40660504
35
,
40660505
36
­
Eggs
and
the
Fat,
Meat,
and
Meat
Byproducts
of
Poultry
None
established
Reserved
40
40660501
37
,
44440604
16
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
38
41967301
39
860.1900:
Field
Rotational
Crops
None
established
Reserved
38
Table
A
(continued).

36
food/
feed
uses
except
seed
treatment
and
requests
that
all
labels
for
the
agricultural
use
of
formulated
lindane
be
revised
to
allow
only
seed
treatment
uses.

3.
A
new
plant
metabolism
study
reflecting
seed
treatment
are
required.
This
study
should
be
conducted
on
a
representative
cereal
grain
as
the
registrants
have
indicated
that
the
only
food/
feed
uses
they
are
supporting
are
for
seed
treatment
of
these
crops.
Crop
samples
should
be
harvested
at
the
appropriate
stage.
In
addition,
care
should
be
taken
to
insure
that
radioactivity
is
not
lost
during
analysis.
Identification
of
14
C­
residues
should
also
be
confirmed
using
more
than
one
method,
or
by
GC/
MS.

4.
CB
No.
3267,
3/
24/
88,
G.
Otakie.

5.
DP
Barcode
D239699,
12/
16/
97,
S.
Funk.

6.
DP
Barcode
D240495,
12/
14/
99,
T.
Morton.

7.
The
qualitative
nature
of
the
residue
in
ruminants
and
poultry
is
adequately
understood.
The
results
of
the
ruminant
and
poultry
metabolism
studies
will
be
presented
to
the
HED
Metabolism
Assessment
Review
Committee
(MARC)
for
determination
of
terminal
residue
of
concern
in
eggs,
milk,
and
animal
tissues
when
an
acceptable
plant
metabolism
study
is
submitted.
If
the
HED
MARC
determines
that
lindane
is
the
only
residue
of
concern
requiring
regulation,
then
the
existing
storage
stability
data
for
livestock
commodities,
the
analytical
method
used
for
data
collection,
and
the
livestock
feeding
studies
will
be
upgraded
to
acceptable
status.

8.
CB
No.
3315,
3/
24/
88,
J.
Onley.

9.
CB
No.
3312,
3/
24/
88,
C.
Deyrup.

10.
DP
Barcode
D257805,
12/
14/
99,
T.
Morton.

11.
DP
Barcode
D271442
and
D274158,
4/
18/
01,
T.
Morton.

12.
Adequate
methods
are
available
for
determination
of
residues
of
lindane
per
se
in/
on
plant
and
animal
commodities.
However,
the
adequacy
of
the
available
analytical
methods
cannot
be
determined
until
the
registrants
submit
acceptable
plant
metabolism
studies
reflecting
seed
treatment,
and
the
HED
MARC
has
determined
the
total
toxic
residues
of
lindane
that
need
to
be
included
in
the
tolerance
expression.
The
registrants
are
reminded
that
radiovalidation
of
enforcement
method(
s)
is
a
reregistration
requirement;
representative
samples
from
the
requested
plant
metabolism
study
should
be
used
for
radiovalidation
and
analyzed
by
the
existing
or
proposed
enforcement
method(
s)
to
determine
whether
total
toxic
residues
are
extracted
from
weathered
samples.

13.
CB
No.
3257,
3/
24/
88,
N.
Dodd.

14.
DP
Barcode
D259318,
8/
30/
00,
T.
Morton.

15.
CB
No.
3261,
3/
24/
88,
N.
Dodd.

16.
DP
Barcode
D242510,
12/
14/
99,
T.
Morton.

17.
Should
the
HED
MARC
determine
that
lindane
metabolites
other
than
the
parent
should
be
regulated,
the
Agency
will
require
the
registrants
to
submit
additional
multiresidue
methods
test
data
for
the
metabolites
of
concern.
Table
A
(continued).

37
18.
Additional
storage
stability
data
(temperature
logs)
are
required
for
the
canola
field
trials
and
the
canola
processing
study.
Storage
stability
data
are
also
required
to
support
the
requested
corn
processing
study.
Additional
storage
stability
data
may
be
required
if
the
HED
MARC
determines
that
additional
lindane
metabolites
of
concern
need
to
be
included
in
the
tolerance
expression.

19.
CB
No.
3260,
3/
24/
88,
N.
Dodd.

20.
CB
No.
7470,
3/
29/
91,
R.
Perfetti.

21.
Assuming
that
lindane
per
se
is
the
terminal
residue
of
concern
in
animal
commodities,
adequate
storage
stability
data
are
available
to
support
the
storage
conditions
and
intervals
of
samples
collected
from
existing
ruminant
and
poultry
feeding
studies.
Additional
storage
stability
data
may
be
required
if
the
HED
MARC
determines
that
additional
lindane
metabolites
of
concern
need
to
be
included
in
the
tolerance
expression.

22.
CB
No.
4035,
8/
23/
88
and
8/
26/
88
(addendum),
S.
Willett.

23.
Because
no
registrants
have
committed
to
support
use(
s)
of
lindane
on
this
crop,
no
residue
data
are
required.
The
Agency
recommends
that
this
use
site
be
deleted
from
all
lindane
end­
use
products.
The
Agency
also
recommends
the
revocation
of
existing
lindane
tolerances,
if
established,
on
the
RACs
of
crops
which
are
not
being
supported.

24.
CB
No.
3259,
3/
24/
88,
N.
Dodd.

25.
Because
no
registrants
have
committed
to
support
use(
s)
of
lindane
on
this
crop,
no
residue
data
are
required.
The
Agency
recommends
that
this
use
site
be
deleted
from
all
lindane
end­
use
products.
The
Agency
also
recommends
the
revocation
of
existing
lindane
tolerances,
if
established,
on
the
RACs
of
crops
which
are
not
being
supported.

26.
Because
no
registrants
have
committed
to
support
use(
s)
of
lindane
on
this
crop,
no
residue
data
are
required.
The
Agency
recommends
that
this
use
site
be
deleted
from
all
lindane
end­
use
products.
The
Agency
also
recommends
the
revocation
of
existing
lindane
tolerances,
if
established,
on
the
RACs
of
crops
which
are
not
being
supported.

27.
Because
no
registrants
have
committed
to
support
use(
s)
of
lindane
on
this
crop,
no
residue
data
are
required.
The
Agency
recommends
that
this
use
site
be
deleted
from
all
lindane
end­
use
products.
The
Agency
also
recommends
the
revocation
of
existing
lindane
tolerances,
if
established,
on
the
RACs
of
crops
which
are
not
being
supported.

28.
CB
No.
8075,
DP
Barcode
D164898,
4/
8/
92,
R.
Perfetti.

29.
Assuming
that
lindane
per
se
is
the
terminal
residue
of
concern
in
plants,
the
available
residue
data,
reflecting
seed
treatment,
for
wheat
grain,
forage,
hay,
and
straw
may
be
translated
to
the
RACs
of
barley,
oats,
and
rye,
provided
the
registrants
propose
identical
use
patterns
and
tolerances.
The
registrants
may
propose
a
maximum
seed
treatment
rate
of
0.
052
oz
ai/
cwt
(or
330
ppm
lindane
on
the
seed)
on
small
cereal
grains
which
is
supported
by
adequate
residue
data.

30.
Assuming
that
lindane
per
se
is
the
terminal
residue
of
concern
in
plants,
two
additional
field
trials
are
required
for
canola.

31.
DP
Barcode
269388
and
D273830,
5/
10/
01,
T.
Morton.
Table
A
(continued).

38
32.
Assuming
that
lindane
per
se
is
the
terminal
residue
of
concern
in
plants,
the
available
seed
treatment
data
for
corn
may
be
translated
to
sorghum,
provided
the
registrants
propose
identical
use
patterns
and
tolerances.

33.
The
registrants
are
required
to
submit
processing
data
to
determine
whether
lindane
residues
of
concern
concentrate
in
the
processed
fractions
of
corn
following
seed
treatment.

34.
CB
No.
4036,
8/
31/
88,
M.
Kovacs.

35.
CB
No.
4038,
8/
29/
88,
S.
Willett.

36.
CB
No.
4037,
9/
20/
88,
M.
Kovacs.

37.
CB
No.
4034,
8/
31/
88,
G.
Otakie.

38.
For
the
purpose
of
reregistration,
the
Agency
will
not
require
a
new
confined
rotational
crop
study
provided
the
registrants
propose
a
30­
day
plantback
interval
for
leafy
vegetables
and
a
12­
month
plantback
interval
for
all
other
unregistered
crops
on
all
of
their
end­
use
product
labels
for
lindane.
If
this
recommendation
is
not
acceptable
to
the
registrants,
then
limited
rotational
field
trial
data
are
required.
The
limited
field
trials
should
be
conducted
on
a
representative
crop
(as
defined
in
40
CFR
180.41)
at
two
sites
per
crop
for
the
following
three
crop
groups:
root
and
tuber
vegetables,
leafy
vegetables
and
small
grains
(wheat,
barley,
oats,
and
rye)
for
a
total
of
six
trials.
As
with
confined
studies
(OPPTS
860.1850),
soybeans
may
be
substituted
for
the
leafy
vegetable.
The
six
trials
should
be
conducted
on
crops
which
a
registrant
intends
to
have
as
rotational
crops
on
the
label.
In
addition,
some
of
the
six
trials
could
be
conducted
using
other
crops
that
are
typically
involved
in
crop
rotation
such
as
alfalfa
and
soybeans.
The
registrant
has
informed
the
Agency
they
will
propose
the
specified
plantback
intervals.

39.
DP
Barcodes
D172626
and
D198353,
8/
30/
00,
T.
Morton.

40.
The
nature
of
the
residue
in
plants
is
not
understood.
Upon
receipt
of
the
requested
plant
metabolism
data,
the
Agency
will:
(I)
determine
the
adequacy
of
established
tolerances
for
animal
commodities;
(ii)
calculate
the
expected
dietary
intake
for
beef
cattle,
dairy
cattle,
and
swine;
and
(iii)
reevaluate
the
need
for
additional
feeding
studies.
Assuming
that
lindane
per
se
is
the
only
residue
of
concern
in
animals,
acceptable
ruminant
and
poultry
feeding
studies
are
available.
39
TOLERANCE
REASSESSMENT
SUMMARY
Tolerances
for
residues
of
lindane
in/
on
raw
agricultural
and
animal
commodities
are
established
under
40
CFR
§180.133
and
expressed
in
terms
of
residues
of
lindane
per
se
[gamma
isomer
of
benzene
hexachloride].
The
residue
definition
for
lindane
is
misleading
and
should
be
amended
as
follows
to
harmonize
with
IUPAC
nomenclature:
gamma
isomer
of
1,
2,
3,
4,
5,
6hexachlorocyclohexane
Plant
commodity
tolerances
for
lindane
were
originally
established
based
on
registered
uses
which
included
preplant
soil
application,
foliar
applications,
and
seed
treatments.
Animal
commodity
tolerances
were
established
based
on
uses
which
included
direct
livestock
animal
treatment
as
well
as
animal
premise
treatment.
Refer
to
Table
B
for
a
list
of
established
lindane
tolerances.

The
only
food/
feed
use
of
lindane
which
is
being
supported
for
reregistration
is
seed
treatment
on
cereal
grains
(excluding
rice
and
wild
rice).

A
definitive
reassessment
of
the
currently
established
tolerances
for
lindane
cannot
be
made
at
this
time
due
to
major
deficiencies
in
the
residue
chemistry
database.
The
Agency
tentatively
concludes
that
no
changes
in
the
present
tolerance
expression
are
required
at
this
time
until
the
nature
of
the
residue
in
plants
and
animals
is
adequately
elucidated,
and
HED's
MARC
has
determined
the
terminal
residues
of
concern.
Because
of
the
Agency's
concerns
about
the
possibility
of
human
health
effects
due
to
dietary
exposure
to
lindane
and
the
lack
of
data
to
support
seed
treatment
uses,
no
additional
tolerances
other
than
those
required
to
support
the
basic
registrants'
proposed
seed
treatment
uses,
will
be
considered
until
the
data
gaps
identified
in
this
Residue
Chemistry
Chapter
are
fulfilled.

The
listing
of
lindane
tolerances
under
40
CFR
§180.133
should
be
subdivided
into
parts
(a),
(b),
(c),
and
(d).
Part
(a)
should
be
reserved
for
commodities
with
permanent
tolerances,
part
(b)
for
Section
18
emergency
exemptions,
part
©
for
tolerances
with
regional
registrations,
and
part
(d)
for
indirect
or
inadvertent
residues.

Tolerances
Listed
Under
40
CFR
§180.133:

Following
resolutions
of
residue
chemistry
data
deficiencies
specified
in
this
Residue
Chemistry
Science
Chapter,
a
statement
in
40
CFR
§180.133
should
be
added
to
specify
that
the
established
tolerances
result
from
seed
treatment
only.

The
established
tolerances
for
the
following
commodities
should
be
revoked
because
no
registrants
have
committed
to
support
their
uses:
apples,
apricots,
asparagus,
avocados,
broccoli,
Brussels
sprouts,
cabbage,
cauliflower,
celery,
cherry,
collards,
cucumbers,
eggplants,
grapes,
guavas,
kale,
kohlrabi,
lettuce,
mangoes,
melons,
mushrooms,
mustard
greens,
nectarines,
okra,
onions
(dry
bulb
only),
peaches,
pears,
pecans,
peppers,
pineapple,
plums
(fresh
prunes),
pumpkins,
quinces,
radish,
spinach,
squash,
strawberries,
summer
squash,
swiss
chard,
and
tomatoes.
40
Tolerances
To
Be
Proposed
Under
40
CFR
§180.133:

Tolerances
for
lindane
residues
of
concern
need
to
be
established
for:
barley,
grain;
barley,
hay;
barley,
straw;
corn,
grain;
corn,
forage;
corn,
stover;
oat,
grain;
oat,
forage;
oat,
hay;
oat,
straw;
rye,
grain;
rye,
forage;
rye,
straw;
sorghum,
grain;
sorghum,
forage;
sorghum,
stover;
wheat,
grain;
wheat,
forage;
wheat,
hay;
and
wheat,
straw
once
required
data
are
submitted.
In
addition,
the
need
for
tolerances
for
livestock
tissues,
milk,
poultry
tissues
and
eggs
will
be
reevaluated
once
additional
plant
metabolism
data
is
submitted.

Pending
Tolerance
Petitions:

In
1993,
CIEL
proposed
to
delete
all
food/
feed
uses
except
seed
treatment.
Concomitantly,
CIEL
proposed
to
establish
tolerances
of
0.1
ppm
for
residues
of
lindane
per
se
in/
on
several
RACs
as
a
result
of
seed
treatment.
In
an
initial
Agency
review
(DP
Barcode
D213401,
10/
31/
95,
S.
Funk)
of
available
residue
data
reflecting
seed
treatment,
the
Agency
concluded
that
the
proposed
tolerances
were
adequate
in
some
instances
and
inadequate
or
non­
acceptable
in
others.
In
those
instances
where
the
proposed
tolerances
were
deemed
inadequate,
the
reviewer
proposed
values
that
HED
would
consider
as
appropriate.

In
1998,
CIEL
submitted
a
petition,
PP#
9F05057,
for
the
establishment
of
time­
limited
tolerances
for
residues
of
lindane
per
se
in/
on
several
commodities
resulting
from
seed
treatment.
The
Agency
review
(DP
Barcodes
D254236,
8/
30/
00,
T.
Morton)
of
these
tolerance
proposals
concluded
that
tolerances
could
not
be
established
until
an
adequate
plant
metabolism
study
was
submitted.

The
registrants
have
also
submitted
PP#
9F6022,
(D269388,
T.
Morton,
5/
10/
01)
for
the
establishment
of
tolerances
on
lindane
per
se
in/
on
canola
for
which
seed
treatment
is
being
proposed.
Tolerances
cannot
be
established
or
reassessed
until
an
adequate
plant
metabolism
study
is
submitted.
41
Table
B.
Tolerance
Reassessment
Summary
for
Lindane.

Commodity
Tolerance
Listed
Under
40
CFR
(ppm)
Reassessed
Tolerance
(ppm)
Comment
[Correct
Commodity
Definition]

Tolerance
Listed
Under
40
CFR
§180.133
Apples
1
Revoke
Not
being
supported
for
reregistration.

Apricots
1
Revoke
Not
being
supported
for
reregistration.

Asparagus
1
Revoke
Not
being
supported
for
reregistration.

Avocados
1
Revoke
Not
being
supported
for
reregistration.

Broccoli
1
Revoke
Not
being
supported
for
reregistration.

Brussels
sprouts
1
Revoke
Not
being
supported
for
reregistration.

Cabbage
1
Revoke
Not
being
supported
for
reregistration.

Cauliflower
1
Revoke
Not
being
supported
for
reregistration.

Lettuce
3
Revoke
Not
being
supported
for
reregistration.

Spinach
1
Revoke
Not
being
supported
for
reregistration.

Celery
1
Revoke
Not
being
supported
for
reregistration.

Collards
1
Revoke
Not
being
supported
for
reregistration.

Kale
1
Revoke
Not
being
supported
for
reregistration.

Kohlrabi
1
Revoke
Not
being
supported
for
reregistration.

Mustard
greens
1
Revoke
Not
being
supported
for
reregistration.

Swiss
chard
1
Revoke
Not
being
supported
for
reregistration.

Cherry
1
Revoke
Not
being
supported
for
reregistration.

Cucumbers
3
Revoke
Not
being
supported
for
reregistration.

Eggplants
1
Revoke
Not
being
supported
for
reregistration.

Fat
of
meat
from
cattle,
goats,
horses,
and
sheep
7
To
be
determined
(TBD)
The
Agency
will
re­
calculate
the
maximum
theoretical
dietary
burden
for
livestock
animals
and
re­
assess
the
adequacy
of
the
available
animal
feeding
studies
when
the
requested
residue
data
for
livestock
feed
items
have
been
received
and
evaluated.
Fat
ofmeat
from
hogs
4
Grapes
1
Revoke
Not
being
supported
for
reregistration.

Guavas
1
Revoke
Not
being
supported
for
reregistration.

Mangoes
1
Revoke
Not
being
supported
for
reregistration.

Melons
3
Revoke
Not
being
supported
for
reregistration.

Mushrooms
3
Revoke
Not
being
supported
for
reregistration.

Nectarines
1
Revoke
Not
being
supported
for
reregistration.

Okra
1
Revoke
Not
being
supported
for
reregistration.

Onions
(dry
bulb
only)
1
Revoke
Not
being
supported
for
reregistration.

Peaches
1
Revoke
Not
being
supported
for
reregistration.

Pears
1
Revoke
Not
being
supported
for
reregistration.

Pecans
0.01
Revoke
Not
being
supported
for
reregistration.

Peppers
1
Revoke
Not
being
supported
for
reregistration.

Pineapple
1
Revoke
Not
being
supported
for
reregistration.
Table
B
(continued).

Commodity
Tolerance
Listed
Under
40
CFR
(ppm)
Reassessed
Tolerance
(ppm)
Comment
[Correct
Commodity
Definition]

42
Plums
(fresh
prunes)
1
Revoke
Not
being
supported
for
reregistration.

Pumpkins
3
Revoke
Not
being
supported
for
reregistration.

Quinces
1
Revoke
Not
being
supported
for
reregistration.

Squash
3
Revoke
Not
being
supported
for
reregistration.

Strawberries
1
Revoke
Not
being
supported
for
reregistration.

Summer
squash
3
Revoke
Not
being
supported
for
reregistration.

Tomatoes
3
Revoke
Not
being
supported
for
reregistration.

Tolerance
To
Be
Proposed
Under
40
CFR
§180.133
Barley,
grain
None
established
TBD
A
nature
of
the
residue
study
for
lindane
residues
resulting
from
seed
treatment
application
to
a
cereal
grain
is
required.
Barley,
hay
TBD
Barley,
straw
TBD
Canola,
seed
TBD
Corn,
grain
TBD
Corn,
forage
TBD
Corn,
stover
TBD
Oat,
grain
TBD
Oat,
forage
TBD
Oat,
hay
TBD
Oat,
straw
TBD
Rape
greens
TBD
Rye,
grain
TBD
Rye,
forage
TBD
Rye,
straw
TBD
Sorghum,
grain
TBD
Sorghum,
forage
TBD
Sorghum,
stover
TBD
Wheat,
grain
TBD
Wheat,
forage
TBD
Wheat,
hay
TBD
Wheat,
straw
TBD
TBD
=
To
be
determined.
43
CODEX
HARMONIZATION
The
Codex
Alimentarius
Commission
has
established
several
maximum
residue
limits
(MRLs)
for
lindane
in/
on
various
plant
and
animal
commodities.
The
Codex
MRLs
are
expressed
in
terms
of
gamma
HCH
(fat­
soluble).
With
respect
to
tolerance
expression,
the
Codex
MRL
and
U.
S.
tolerance
for
lindane
are
presently
in
harmony.
However,
the
nature
of
the
residue
in
plants
and
ruminants
remains
inadequately
understood,
and
the
HED's
MARC
may
determine
that
additional
lindane
metabolites
should
be
included
in
the
U.
S.
tolerance
expression.

A
numerical
comparison
of
the
Codex
MRLs
and
the
corresponding
reassessed
U.
S.
tolerances
resulting
from
seed
treatment
is
presented
in
Table
C.
The
established
Codex
MRLs
and
the
recommended
U.
S.
tolerances
for
Brussels
sprouts,
cabbage
(Savoy),
cabbages
(head),
cereal
grains,
lettuce
(head),
and
radish
are
not
in
harmony
presumably
because
of
differences
in
good
agricultural
practices.
Attempts
to
harmonize
residue
limits
in
animal
commodities
cannot
be
made
at
this
time
because
of
several
residue
chemistry
data
gaps.
44
(continued
next
page).
Table
C.
Codex
MRLs
and
applicable
U.
S.
tolerances
for
lindane.
Recommendations
are
based
on
conclusions
following
reassessment
of
U.
S.
tolerances
(see
Table
B).

Codex
Reassessed
U.
S.
Tolerance,
ppm
1
Codex
Comments
Commodity,
As
Defined
MRL
in
mg/
kg
(Step)

Apple
0.
5
(CXL)
Revoke
Not
being
supported
for
reregistration.

Beans
(dry)
1
(CXL)
2
None
established
Not
being
supported
for
reregistration.

Brussels
sprouts
0.
5
(CXL)
Revoke
Not
being
supported
for
reregistration.

Cabbage,
Savoy
0.5
(CXL)
Revoke
Not
being
supported
for
reregistration.

Cabbages,
Head
0.5
(CXL)
Revoke
Not
being
supported
for
reregistration.

Cacao
beans
1
(CXL)
None
established
Not
being
supported
for
reregistration.

Carrot
0.
2
(CXL)
None
established
Not
being
supported
for
reregistration.

Cauliflower
0.
5
(CXL)
Revoke
Not
being
supported
for
reregistration.

Cereal
grains
0.
5
(CXL)
2
TBD
for
the
grains
of
barley,
oats,
rye,
and
wheat
Cherries
0.5
(CXL)
Revoke
Not
being
supported
for
reregistration.

Cocoa
butter
1
(CXL)
None
established
Not
being
supported
for
reregistration.

Cocoa
mass
1
(CXL)
None
established
Not
being
supported
for
reregistration.

Cranberry
3
(CXL)
None
established
Not
being
supported
for
reregistration.

Currant,
Red,
White
0.5
(CXL)
None
established
Not
being
supported
for
reregistration.

Eggs
0.1
(CXL)
None
established
Endive
2
(CXL)
None
established
Not
being
supported
for
reregistration.

Grapes
0.5
(CXL)
Revoke
Not
being
supported
for
reregistration.

Kohlrabi
1
(CXL)
Revoke
Not
being
supported
for
reregistration
Lettuce,
Head
2
(CXL)
Revoke
Not
being
supported
for
reregistration.

Meat
of
cattle,
pigs,
and
sheep
2
(CXL)
To
be
determined
(TBD)

Milks
0.
1
(CXL)
None
established
Pear
0.5
(CXL)
Revoke
Not
being
supported
for
reregistration.

Peas
(pods
and
succulent
=
immature
seeds)
0.1
(CXL)
None
established
Not
being
supported
for
reregistration.

Plums
(including
prunes)
0.
5
(CXL)
Revoke
Not
being
supported
for
reregistration.

Potato
0.05
(CXL)
None
established
Not
being
supported
for
reregistration.

Poultry
meat
0.
7
(CXL)
None
established
Radish
1
(CXL)
Revoke
Not
being
supported
for
reregistration.

Rape
seed
0.05
(CXL)
None
established
Spinach
2
(CXL)
Revoke
Not
being
supported
for
reregistration.

Strawberry
3
(CXL)
Revoke
Not
being
supported
for
reregistration.
Codex
Reassessed
U.
S.
Tolerance,
ppm
1
Codex
Comments
Commodity,
As
Defined
MRL
in
mg/
kg
(Step)

45
Sugar
beet
0.1
(CXL)
None
established
Not
being
supported
for
reregistration.

Sugar
beet
leaves
or
tops
0.1
CXL)
None
established
Not
being
supported
for
reregistration.

Tomato
2
(CXL)
Revoke
Not
being
supported
for
reregistration.

1
Reassessed
U.
S.
tolerances
pending
compliance
by
the
registrants
with
the
recommendations
specified
in
"GLN
860.1200:
Directions
for
Use"
section
of
this
Chapter.
2
Postharvest
treatment
of
the
commodity.
TBD
=
To
be
determined.

DIETARY
EXPOSURE
ASSESSMENT
Anticipated
residues
of
lindane
were
recently
determined
by
HED
(DP
Barcode
D279260,
T.
Morton,
12/
4/
01)
using
data
from
available
plant
and
animal
metabolism
studies
along
with
animal
feeding
studies.
46
AGENCY
MEMORANDA
RELEVANT
TO
REREGISTRATION
CB
No.:
3257
Subject:
ID
No.
359­
686.
Lindane
Registration
Standard
Followup.
Analytical
Methods
for
Plants
From:
N.
Dodd
To:
A.
Rispin,
G.
LaRocca,
and
E.
Budd
Dated:
3/
24/
88
MRID(
s):
40431202
and
40431206
CB
No.:
3259
Subject:
ID
No.
359­
686.
Lindane
Registration
Standard
Followup
­
Residues
From
Seed
Treatment
From:
N.
Dodd
To:
A.
Rispin,
G.
LaRocca,
and
E.
Budd
Dated:
3/
24/
88
MRID(
s):
40431207
CB
No:
3260
Subject:
Lindane
Registration
Standard
Follow
up.
Storage
stability.
From:
N.
Dodd
To:
A.
Rispin,
G.
LaRocca,
and
E.
Budd
Dated:
3/
24/
88
MRIDs:
40431203
and
40431205
CB
No:
3261
Subject:
Lindane
Registration
Standard
Follow
up
­
Analytical
Methods
for
Animal
Tissues,
Eggs,
and
Milk.
From:
N.
Dodd
To:
A.
Rispin,
G.
LaRocca,
and
E.
Budd
Dated:
3/
24/
88
MRID:
40431208
CB
No.
3267
Subject:
Partial
Response
(November
10,
1987)
by
Centre
International
d'Etudes
du
Lindane
(CIEL)
to
Data
Gap
171­
4
(Nature
of
the
Residue
in
Plants
as
Identified
in
the
Residue
Chemistry
Chapter
of
the
September
30,
1985
Lindane
Registration
Standard
From:
G.
Otakie
To:
A.
Rispin,
G.
LaRocca,
and
E.
Budd
Dated:
3/
24/
88
MRID(
s):
40410902,
40431201,
and
40431204
CB
No:
3312
Subject:
Partial
Response
(7/
21/
87)
by
Centre
International
d'Etudes
du
Lindane
(CIEL)
to
Data
Gap
171­
4
(Nature
of
the
Residue
in
Livestock
Ruminants)
as
Identified
in
the
Residue
Chemistry
Chapter
of
the
September
30,
1985
Lindane
Registration
Standard.
From:
C.
Deyrup
To:
A.
Rispin,
G.
LaRocca,
and
E.
Budd
Dated:
3/
24/
88
MRID:
40271302
47
DEB
No.
3315
Subject:
Partial
Response
(July
15,
1987)
by
Centre
International
d'Etudes
du
Lindane
(CIEL)
to
Data
Gap
171­
4
(Nature
of
the
Residue
in
Livestock
Poultry)
as
Identified
in
the
Residue
Chemistry
Chapter
of
the
September
30,
1985
Lindane
Registration
Standard
From:
J.
Onley
To:
A.
Rispin,
G.
LaRocca,
and
E.
Budd
Dated:
3/
24/
88
MRID(
s):
40271301
CB
No:
4035
Subject:
ID
No.
52904­
C.
Lindane
Registration
Standard
Followup.
Storage
Stability
Data.
From:
S.
Willett
To:
R.
Engler,
G.
LaRocca,
and
E.
Budd
Dated:
8/
23/
88
and
8/
26/
88
(addendum)
MRID:
40660502
CB
No:
4034
Subject:
Partial
Response
(June
9,
1988)
by
Centre
International
d'Etudes
du
Lindane
(CIEL)
to
Data
Gap
Section
171­
4
(Magnitude
of
the
Residue
in
Poultry
and
Eggs)
as
Identified
in
the
Residue
Chemistry
Chapter
of
the
September
30,
1985
Lindane
Registration
Standard.
From:
G.
Otakie
To:
R.
Engler,
G.
LaRocca,
andE.
Budd
Dated:
8/
31/
88
MRID:
40660501
CB
No.:
4038
Subject:
ID
No.
52904­
C.
Lindane
Registration
Standard
Followup.
Residues
in
Swine
From:
S.
Willett
To:
R.
Engler,
G.
LaRocca,
andE.
Budd
Dated:
8/
29/
88
MRID(
s):
40660504
CB
No.:
4036
Subject:
Partial
Response
(April
7,
1988)
by
Centre
International
d'Etudes
du
Lindane
(CIEL)
to
Data
Gap
Section
171­
4
[Magnitude
of
Residue
in
Animals
(Sheep)]
as
Identified
in
the
Residue
Chemistry
Chapter
of
the
September
30,
1985
Lindane
Registration
Standard.
From:
M.
Kovacs
To:
R.
Engler,
G.
LaRocca,
andE.
Budd
Dated:
8/
31/
88
MRID(
s):
40660503
CB
No.:
4037
Subject:
Partial
Response
(December
15,
1987)
by
Centre
International
d'Etudes
du
Lindane
(CIEL)
to
Data
Gap
171­
4
[Magnitude
of
Residue
in
Animals
(Dairy
Cattle
Meat
and
Milk)]
as
Identified
in
the
Residue
Chemistry
Chapter
of
the
September
30,
1985
Lindane
Registration
Standard
From:
M.
Kovacs
To:
R.
Engler,
G.
LaRocca,
E.
Budd
Dated:
9/
20/
88
MRID(
s):
40660505
48
CB
No.:
7470
Subject:
Rhone­
Poulenc
AG
Company:
Response
to
the
Lindane
Reregistration
Standard:
Crop
field
Trials
and
Storage
Stability
Data
From:
R.
Perfetti
To:
R.
Engler
and
L.
Rossi
Dated:
3/
29/
91
MRID:
41699701
CB
No.
8075
DP
Barcode:
D164898
Subject:
CIEL:
Response
to
the
Lindane
Reregistration
Standard:
Residue
and
Processing
Data
From:
R.
Perfetti
To:
W.
Burnam
and
L.
Rossi
Dated:
4/
8/
92
MRID:
41861201
and
41861202
CB
No.
15325
DP
Barcode:
D213401
Subject:
Lindane
(Case
0315,
Chemical
009001,
List
A).
Seed
Treatment
Uses.
From:
S.
Funk
To:
L.
Schnaubelt/
R.
Richards
Dated:
10/
31/
95
MRID:
None
DP
Barcode:
D239699
Subject:
Lindane
(Chemical
009001,
List
A):
CIEL
Submissions
to
Upgrade
Plant
Analytical
Method,
Nature
of
the
Residue
in/
on
Cucumbers,
Nature
of
the
Residue
in/
on
Apples.
Time
Extension
Request
for
Ruminant
Feeding
Study,
Ruminant
Commodity
Storage
Stability
Study,
and
Ruminant
Commodity
Analytical
Method
Study.
From:
S.
Funk
To:
S.
Jennings/
W.
Waldrop
Dated:
12/
16/
97
MRID(
s):
44383001
through
44383004
DP
Barcode:
D240495
Subject:
Lindane
(009001):
Nature
of
the
Residue
in
Spinach
and
Poultry
(GLN
860.1300).
From:
T.
Morton
To:
M.
McDavit/
B.
Shackleford
Dated:
12/
14/
99
MRID(
s):
44405403
and
44405404
DP
Barcode:
D242510
Subject:
Lindane
(009001):
Nature
of
the
Residue
in
Plants
and
Animals
(GLN
860.1300),
Storage
Stability
(GLN
860.1380),
Residue
Analytical
Method
(GLN
860.1340),
and
Meat,
Milk,
Poultry,
Eggs
(GLN
860.1480).
From:
T.
Morton
To:
M.
McDavit/
B.
Shackleford
Dated:
12/
14/
99
MRID(
s):
44440601,
44440602,
44440603,
and
44440604.
49
DP
Barcode:
D257805
Subject:
Lindane
(009001):
Nature
of
the
Residue
in
Livestock
(GLN
860.1300),
Residue
Analytical
Method
(GLN
860.1340),
and
Storage
Stability
(GLN
860.1380).
From:
T.
Morton
To:
M.
McDavit/
B.
Shackleford
Dated:
12/
14/
99
MRID(
s):
44867104,
44867105,
and
44867106
DP
Barcode:
D259318
Subject:
Lindane
(009001):
Magnitude
of
the
Residue
in/
on
Wheat
From:
T.
Morton
To:
M.
Howard/
B.
Shackleford
Dated:
8/
30/
00
MRID(
s):
44909901
DP
Barcode:
D254236
and
D265919
Subject:
PP#
9F05057.
Lindane
(009001):
Time
Limited
Tolerances
for
Various
Crops.
From:
T.
Morton
To:
M.
Howard/
B.
Shackleford
Dated:
8/
30/
00
MRID(
s):
None
DP
Barcode:
D172626
and
D198353
Subject:
Lindane:
Confined
Rotational
Crop
Study.
From:
T.
Morton
To:
M.
Howard/
B.
Shackleford
Dated:
8/
30/
00
MRID(
s):
41967301
DP
Barcode:
D269094
Subject:
Lindane
(009001):
Waiver
Request
for
Nature
of
the
Residue
in
Plants
Grown
From
Seed
Treated
With
Lindane
(GLN
860.1300).
From:
T.
Morton
To:
M.
Howard/
B.
Shackleford
Dated:
1/
9/
01
MRID(
s):
None
DP
Barcode:
D272625
Subject:
Lindane
(009001):
Clarification
on
Waiver
Request
for
Nature
of
the
Residue
in
Plants
Grown
From
Seed
Treated
With
Lindane
(GLN
860.1300).
From:
T.
Morton
To:
M.
Howard/
B.
Shackleford
Dated:
2/
13/
01
MRID(
s):
None
DP
Barcode:
D243547
Subject:
Lindane
(009001):
Question
on
Applicability
of
Seed
Treatment
Data
for
Pre­
Plant
Soil
Treatment
Uses.
From:
T.
Morton
To:
M.
Howard/
B.
Shackleford
Dated:
2/
28/
01
MRID(
s):
None
50
DP
Barcode:
D244798
Subject:
Lindane
(009001):
Status
on
Residue
Chemistry
Requirements
for
Lindane
Seed
Treatment
Uses.
From:
T.
Morton
To:
M.
Howard/
B.
Shackleford
Dated:
3/
13/
01
MRID(
s):
None
DP
Barcode:
D258079
Subject:
Lindane
(009001):
Magnitude
of
the
Residue
in
Meat
and
Milk
of
Dairy
Cattle
(GLN
860.1480).
From:
T.
Morton
To:
M.
Howard/
B.
Shackleford
Dated:
3/
13/
01
MRID(
s):
44877501
DP
Barcode:
D269388
and
D273830
Subject:
PP#
9F6022
Lindane
(009001):
Lindane
in/
on
Canola.
From:
T.
Morton
To:
M.
Howard/
B.
Shackleford
Dated:
5/
10/
01
MRID(
s):
44864401
and
45310501
DP
Barcode:
D271442
and
D274158
Subject:
Lindane:
Nature
of
the
Residue
in
Livestock.
From:
T.
Morton
To:
M.
Howard/
B.
Shackleford
Dated:
4/
18/
01
MRID(
s):
45224101,
45224102,
45277201
DP
Barcode:
D274313
Subject:
Lindane
(009001):
Magnitude
of
the
Residue
in
Wheat.
From:
T.
Morton
To:
M.
Howard/
B.
Shackleford
Dated:
5/
10/
01
MRID(
s):
45330301
MASTER
RECORD
IDENTIFICATION
NUMBERS
References
Used
To
Support
Reregistration
00025685
Williams,
S.;
Mills,
P.
A.;
McDowell,
R.
E.
(1964)
Residues
in
milk
of
cows
fed
rations
containing
low
concentrations
of
five
Chlorinated
hydrocarbon
pesticides.
Journal
of
the
Association
of
Official
Analytical
Chemists
47(
6):
1124­
1128.
(unpublished
submission
received
Nov
5,
1970
under
1F1060;
submitted
by
Velsicol
Chemical
Corp.,
Chicago,
Ill.;
CDL:
099195­
AK)

00025690
Cummings,
J.
G.;
Eidelman,
M.;
Turner,
V.;
et
al.
(1967)
Residues
in
poultry
tissues
from
low
level
feeding
of
five
Chlorinated
hydrocarbon
insecticides
to
hens.
Journal
of
the
Association
of
Official
Analytical
Chemists
50(
2):
418­
425.
(unpublished
submission
received
Nov
5,
1970
under
1F1060;
submitted
by
Velsicol
Chemical
Corp.,
Chicago,
Ill.;
CDL:
099195­
AQ)

00025707
Hill,
K.
R.
(1970)
Pesticide
residues:
IUPAC
commission
on
terminal
residues.
Journal
of
the
Association
of
Official
Analytical
Chemists
53(
5):
987­
1003.
(unpublished
submission
received
Nov
5,
1970
under
1F1060;
submitted
by
Velsicol
Chemical
Corp.,
Chicago,
Ill.;
CDL:
099195­
BH)
51
00032233
Dionne,
E.;
Cary,
G.
A.;
Sleight,
B.
H.,
III
(1980)
Analytical
Procedure
for
the
Determination
of
Pesticides
and
PCB
in
Brine
Shrimp
Tissue.
(Unpublished
study
received
Feb
19,
1980
under
677­
313;
prepared
by
EG&
G,
Bionomics,
submitted
by
Diamond
Shamrock
Agricultural
Chemicals,
Cleveland,
Ohio;
CDL:
099247­
K)

00045126
Claborn,
H.
V.;
Radeleff,
R.
D.;
Bushland,
R.
C.
(1960)
Pesticide
Residues
in
Meat
and
Milk:
A
Research
Report.
(U.
S.
Agricultural
Research
Service,
Entomology
Research,
Div.
And
Animal
Disease
and
Parasite
Research
Div.,
unpublished
study;
CDL:
093429­
S)

00060143
Saha,
J.
G.
(1969)
Letter
sent
to
P.
E.
Porter
dated
Mar
10,
1969
[Metabolism
of
Lindane­
14C
by
wheat
plants].
(Canada,
Dept.
of
Agriculture,
Research
Branch,
unpublished
study;
CDL:
091355­
S)

00060150
Lichtenstein,
E.
P.;
Fuhremann,
T.
W.;
Scopes,
N.
E.
A.;
et
al.
(1967)
Translocation
of
insecticides
from
soils
into
pea
plants:
Effects
of
the
detergent
LAS
on
translocation
and
plant
growth.
Journal
of
Agricultural
and
Food
Chemistry
15(
5):
864­
869.
(unpublished
submission
received
Apr
5,
1969
under
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00075989
Chevron
Chemical
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Milk
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399;
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Gyrisco,
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Cornell
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Animal
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N.
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National
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Chemicals
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Supplementary
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00089592
California
Spray
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Residues
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00099909
Shell
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Determination
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GLC­
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Radeleff,
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Effects
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00104441
Hornstein,
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Lowering
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Caro,
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Accumulation
by
plants
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organochlorine
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Phytopathology
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unknown
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Hercules,
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Agricultural
Chemicals,
Wilmington,
DE;
CDL:
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AM)

00118722
National
Agricultural
Chemicals
Assoc.
(1955)
[Residues
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Lindane
in
Agricultural
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Cow
Products].
(Compilation;
unpublished
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24,
1956
under
PP0058;
CDL:
092338­
A)

00118723
California
Spray­
Chemical
Corp.
(1959)
[Lindane
Residues
in
Milk
and
Meat].
(Compilation;
unpublished
study
received
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unknown
date
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PP0190;
CDL:
092466­
A)
52
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Collett,
J.;
Harrison,
D.
(1968)
Lindane
residues
on
pasture
and
in
the
fat
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sheep
grazing
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N.
Z.
Jl
Agric.
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600.
(unpublished
submission
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1969
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9E0833;
submitted
by
Office
of
the
Commissioner,
Washington,
DC;
CDL:
093535­
A)

00118725
National
Agricultural
Chemicals
Assoc.
(1955)
The
Results
of
Tests
on
the
Amount
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Residue
Remaining,
Including
a
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the
Analytical
Method
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[Lindane].
(Compilation;
unpublished
study
received
on
unknown
date
under
PP0058;
CDL:
098733­
A)

00118739
Chevron
Chemical
Co.
(1949)
[BHC:
Residues
in
Milk].
(Compilation;
unpublished
study
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on
unknown
date
under
239­
229;
CDL:
224548­
A)

05002348
Burke,
J.;
Johnson,
L.
(1962)
Investigations
in
the
use
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the
micro­
coulometric
gas
chromatograph
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pesticide
residue
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Journal
of
the
Association
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Official
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45(
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348­
354
05003005
Kovacs,
M.
F.,
Jr.
(1966)
Rapid
detection
of
chlorinated
pesticide
residues
by
an
improved
TLC
technique:
3
1/
4
X
4"
micro
slides.
Journal
of
the
Association
of
Official
Analytical
Chemists
49(
2):
365­
370
05006312
Osadchuk,
M.;
Romach,
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McCully,
K.
A.
(1971)
Cleanup
and
separation
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for
multipesticide
residue
analysis
in
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regulatory
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Pages
357­
381,
in
Pesticide
Chemistry:
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the
International
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2nd;
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22­
26,
1971,
Tel­
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Israel.
Vol.
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in
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Edited
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40271301
Merricks,
D.
(1987)
Determining
the
Metabolic
Fate
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Radiolabeled
Lindane
Fed
to
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Hens:
Laboratory
Project
No.
1503.
Unpublished
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47
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40271302
Wilkes,
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Mulkey,
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al.
(1987)
Metabolism
Study
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Carbon
14­
Lindane
Fed
of
Topically
Applied
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Laboratory
Project
No.
ADC
957.
Unpublished
study
prepared
by
Analytical
Development
Corp.,
in
cooperation
with
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Poulenc
Inc.
304
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40410902
Gemma,
A.
(1987)
Metabolism
of
Carbon
14­
Lindane
in/
on
Apple
Leaves
and
Fruit
after
Treatment
with
Carbon
14­
Lindane
25%
EC:
Project
No.:
799R14:
File
No.:
40152.
Unpublished
study
prepared
by
Rhone­
Poulenc
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89
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40431201
England,
D.
(1987)
Insecticides:
Lindane:
Metabolism
in
Spinach
Plants
Following
Post­
emergence
Application:
Laboratory
Project
ID:
D.
Ag.
571.
Unpublished
study
prepared
by
May
&
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62
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40431202
Godward,
P.
(1987)
Insecticides:
Lindane:
Analytical
Procedure
for
the
Determination
of
Residues
in
Spinach:
Laboratory
Project
ID:
D.
Ag.
573.
Unpublished
study
prepared
by
May
&
Baker
Ltd.
41
p.

40431203
Godward,
P.
(1987)
Insecticides:
Lindane:
Storage
Stability
Study
on
Fortified
Spinach
Samples:
Laboratory
Project
ID:
D.
Ag
572.
Unpublished
study
prepared
by
May
&
Baker
Ltd.
20
p.

40431204
England,
D.
(1987)
Insecticides:
Lindane:
Metabolism
in
Cucumber
Plants
Following
Post­
emergency
Application:
Laboratory
Project
ID:
D.
Ag.
570.
Unpublished
study
prepared
by
May
&
Baker
Ltd.
96
p.

40431205
England,
P.
(1987)
Insecticides:
Lindane;
Storage
Stability
Study
on
Fortified
Cucumber
Samples:
Laboratory
Project
ID:
D.
Ag
569.
Unpublished
study
prepared
by
May
&
Baker
Ltd.
20
p.

40431206
Godward,
P.
(1987)
Insecticides:
Lindane:
Analytical
Procedure
for
the
Determination
of
Residues
in
Cucumber:
Laboratory
Project
ID:
D.
Ag.
568.
Unpublished
study
prepared
by
May
&
Baker
Ltd.
41
p.
53
40431207
Piznik,
M.
(1987)
The
Uptake
and
Translocation
of
Radioactive
Residues
in
Plants
Grown
from
Seeds
Treated
with
a
Carbon
14
Radiolabelled
Lindane
Emulsifiable
Concentrate
(EC)
Formulation:
ASD
No.
87/
243.
Unpublished
study
prepared
by
Rhone­
Poulenc
Inc.
107
p.

40431208
Piznik,
M.
(1987)
An
Analytical
Method
for
the
Determination
of
Lindane
in
Animal
Tissues,
Eggs
and
Milk:
Laboratory
Project
ID:
ASD
No.
87/
241.
Unpublished
study
prepared
by
Rhone­
Poulenc
Inc.
36
p.

40660501
Merricks,
D.
(1988)
Lindane
Tissue
and
Egg
Residue
Study
in
Poultry:
Final
Report:
Agrisearch
Project
No.
1507.
Unpublished
study
prepared
by
Agrisearch,
Inc.
96
p.

40660502
Piznik,
M.;
Ziegelbein,
J.;
Margitics,
I.;
et
al.
(1988)
Freezer
Storage
Stability
of
Lindane
in
Animal
Tissues,
Eggs,
and
Milk:
Project
No.
799R14.
Unpublished
study
prepared
by
Rhone­
Poulenc
Ag
Co.
38
p.

40660503
Billings,
T.
(1988)
Tissue
Residue
Study
in
Sheep
Using
Lindane:
Laboratory
Project
No.
8705o.
Unpublished
study
prepared
by
Southwest
Bio­
Labs,
Inc.
285
p.

40660504
Billings,
T.
(1988)
Tissue
Residue
Study
in
Swine
Using
Lindane:
Laboratory
Project
No.
8704s.
Unpublished
study
prepared
by
Southwest
Bio­
Labs,
Inc.
259
p.

40660505
Billings,
T.
(1988)
Tissue
Residue
Study
in
Swine
Using
Lindane:
Laboratory
Project
No.
8704s.
Unpublished
study
prepared
by
Southwest
Bio­
Labs,
Inc.
259
p.

41289401
Landis
Associates,
Inc.
(1988)
Lindane
25%
WP:
Raw
Agricultural
Commodity
Field
Residue
Protocol
on
Apples
in
California,
Michigan,
New
York,
Pennsylvania,
North
Carolina,
and
Washington:
Lab
Project
Number:
HLA/
6237/
116A.
Unpublished
study
prepared
by
Hazleton
Laboratories
America,
Inc.
386
p.

41289402
Landis
Associates,
Inc.
(1989)
Lindane
25%
WP:
Processed
Commodity
Field
Residue
Protocol
on
Apples
in
California,
Michigan,
North
Carolina,
and
Washington:
Lab
Project
Number:
HLA/
6237/
116PA.
Unpublished
study
prepared
by
Hazleton
Laboratories,
America.
588
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41289403
Landis
Associates,
Inc.
(1989)
Lindane
25%
WP
&
40%
F:
Raw
Agricultural
Commodity
Field
Residue
Protocol
on
Cabbage
in
California,
New
York,
Florida,
Georgia,
Texas,
and
Wisconsin:
Lab
Project
Number:
HLA/
6237/
116CA.
417
p.

41289404
Landis
Associates,
Inc.
(1989)
Lindane
25%
WP
&
Lindane
40%
F:
Raw
Agricultural
Commodity
Field
Residue
Protocol
on
Cucumbers
in
California,
Ohio,
and
Michigan:
Lab
Project
Number:
HLA/
6237/
116CU.
Unpublished
study
prepared
by
Hazleton
Laboratories,
America
438
p.

41289405
Landis
Associates,
Inc.
(1988)
Lindane
20%
EC:
Raw
Agricultural
Commodity
Field
Residue
Protocol
on
Grapes
in
California,
Michigan,
New
York,
and
Washington:
Lab
Project
Number:
HLA/
6237/
116G.
Unpublished
study
prepared
by
Hazleton
Laboratories
America,
Inc.
333
p.

41289406
Landis
Associates,
Inc.
(1988)
Lindane
20%
EC:
Processed
Commodity
Field
Residue
Protocol
on
Grapes
in
California,
New
York,
and
Washington:
Lab
Project
Number:
HLA/
6237/
116PG.
Unpublished
study
prepared
by
Hazleton
Laboratories
America,
Inc.
367
p.

41289407
Landis
Associates,
Inc.
(1989)
Lindane
25%
WP
and
40%
F:
Raw
Agricultural
Commodity
Field
Residue
Protocol
on
Lettuce
in
California,
Texas,
New
York,
and
New
Jersey:
Lab
Project
Number
HLA/
6237/
116L.
Unpublished
study
prepared
by
Hazleton
Laboratories
America,
Inc.
471
p.

41289408
Landis
Associates,
Inc.
(1989)
Lindane
25%
WP:
Raw
Agricultural
Commodity
Field
Residue
Protocol
on
Peaches
in
California,
Michigan,
Washington,
Pennsylvania,
and
Georgia:
Lab
Project
Number:
HLA/
6237/
116P.
Unpublished
study
prepared
by
Hazleton
Laboratories
America,
Inc.
345
p.
54
41289409
Landis
Associates,
Inc.
(1989)
Lindane
20%
EC:
Raw
Agricultural
Commodity
Field
Residue
Protocol
on
Tobacco
in
Virginia
and
Georgia:
Lab.
Project
No.
HLA/
6237/
116P.
Unpublished
study
prepared
by
Hazleton
Laboratories
America,
Inc.
237
p.

41289601
Landis
Associates,
Inc.
(1989)
Lindane
20%
EC:
Raw
Agricultural
Commodity
Field
Residue
Protocol
on
Pecans
in
Louisiana,
Texas,
and
Oklahoma:
Lab
Project
Number:
6237/
116.Unpublished
study
prepared
by
Hazleton
Laboratories
America,
Inc.
257
p.

41421001
Walker,
K.
(1990)
Lindane
20
[Percent]
EC:
Raw
Agricultural
Commodity
Field
Residue
Protocol
on
Pecans
in
Louisiana:
Lab
Project
Number:
6237­
116
PC.
Unpublished
study
prepared
by
Hazleton
Laboratories
America,
Inc.
153
p.

41699701
Landis
International,
Inc.
(1990)
Lindane
25%
WP:
Raw
Agricultural
Commodity
Field
Residue
on
Tomatoes
in
Florida,
Pennsylvania,
California,
New
Jersey,
Indiana,
Michigan,
and
South
Carolina:
Lab
Project
Number:
HLA
6237­
116PT:
W714­
89­
44­
04­
15B­
02.
Unpublished
study
prepared
by
Hazleton
Laboratories
America,
Inc.
568
p.

41861201
Landis
International,
Inc.
(1990)
Lindane
25(
percent)
WP
and
Lindane
40%
F:
Processed
Commodity
Field
Residue
Protocol
on
Tomatoes
in
California,
New
Jersey,
Pennsylvania,
and
Michigan:
Lab
Project
Number:
6237­
116PT:
1717­
89­
44­
04­
15B­
08:
1714­
89­
44­
04­
15B­
04.
Unpublished
study
prepared
by
Hazleton
Laboratories
America,
Inc.
742
p.

41861202
Hattermann,
D.
(1991)
Lindane
20%
EC:
Processed
Commodity
Residue
Evaluation
Study
on
Tomatoes
in
California:
Lab
Project
Number:
714­
90­
44­
01­
15B­
01:
6237­
130.
Unpublished
study
prepared
by
Hazleton
Wisconsin,
Inc.
65
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41967301
Hurshman,
B.;
Xiao,
G.
(1991)
Confined
Accumulation
Studies
on
Rotational
Crops
for
Lindane:
Lab
Project
Number:
36976:
EF­
88­
41.Unpublished
study
prepared
by
ABC
Labs
and
Pan­
Agricultural
Labs.,
Inc.
120
p.

44383001
Curry,
K.;
Brookman,
D.
(1997)
Metabolism
of
(carbon
14)­
Lindane
in/
on
Apple
Leaves
and
Fruit
After
Treatment
With
(carbon
14)­
Lindane
25%
EC:
Supplement:
Lab
Project
Number:
799R14:
40152.
Unpublished
study
prepared
by
Rhone­
Poulenc
Inc.
40
p.

44383002
Curry,
K.;
Brookman,
D.
(1997)
Insecticides:
Lindane­­(
carbon
14)­
Metabolism
in
Cucumber
Plants
Following
Post­
Emergence
Application:
Supplement:
Lab
Project
Number:
5738:
5812:
EC/
86/
004/
01.
Unpublished
study
prepared
by
May
&
Baker
Ltd.
68
p.

44383003
Curry,
K.;
Brookman,
D.
(1997)
Insecticides:
Lindane:
Analytical
Procedure
for
the
Determination
of
Residues
in
Cucumber:
Supplement:
Lab
Project
Number:
D.
AG
568.
Unpublished
study
prepared
by
May
&
Baker
Ltd.
11
p.

44383004
Curry,
K.;
Brookman,
D.
(1997)
Insecticides:
Lindane:
Analytical
Procedure
for
the
Determination
of
Residues
in
Cucumber:
Supplement:
Lab
Project
Number:
D.
AG
568.
Unpublished
study
prepared
by
May
&
Baker
Ltd.
11
p.

44405403
Curry,
K.;
Brookman,
D.
(1997)
Insecticides:
Lindane­­(
carbon
14)
Metabolism
in
Spinach
Plants
Following
Post­
Emergence
Application:
Supplement
Report:
Lab
Project
Number:
5739:
STUDY/
EC/
86/
001/
01:
STUDY/
EC/
86/
001/
02.
Unpublished
study
prepared
by
Technology
Sciences
Group
Inc.
53
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44405404
Curry,
K.;
Brookman,
D.
(1997)
Determining
the
Metabolic
Fate
of
Radiolabeled
Lindane
Fed
to
Laying
Hens:
Supplement
Report:
Lab
Project
Number:
1503.
Unpublished
study
prepared
by
Technology
Sciences
Group
Inc.
308
p.
55
44440601
Curry,
K.;
Brookman,
D.
(1997)
Insecticides:
Lindane:
Analytical
Procedure
for
the
Determination
of
Residues
in
Poultry
Tissues
and
Eggs.
Unpublished
study
Centre
International
d'Etudes
du
Lindane.
42
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44440602
Curry,
K.;
Brookman,
D.
(1997)
Insecticides:
Lindane:
Freezer
Storage
Stability
Study
on
Fortified
Spinach
and
Cucumber
Samples:
Supplement:
Lab
Project
Number:
572:
569.
Unpublished
study
prepared
by
Technology
Sciences
Group,
Inc.
21
p.

44440603
Curry,
K.;
Brookman,
D.
(1997)
Freezer
Storage
Stability
of
Lindane
in
Animal
Tissues,
Eggs
and
Milk:
Supplement.
Unpublished
study
prepared
by
Technology
Sciences
Group,
Inc.
28
p.

44440604
Curry,
K.;
Brookman,
D.
(1997)
Freezer
Storage
Stability
of
Lindane
in
Animal
Tissues,
Eggs
and
Milk:
Supplement.
Unpublished
study
prepared
by
Technology
Sciences
Group,
Inc.
28
p.

44864401
Willard,
T.
(1999)
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Magnitude
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Raw
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Treatment
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GS­
00010:
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Antonio,
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P.
"Demonstration
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and
a
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Ag.
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GS­
00012:
Herbst
M.
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G.
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"Investigations
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either
in
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or
Planned."
Presented
at
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EPA
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12/
18/
75.

GS­
00013:
Itokawa,
H.,
et
al.
"Beitrage
zur
Okologischen
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XXII,
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und
Ruckverhalten
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14C
in
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Pflanzen,
Tetrahedron,
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763­
773,
1970.

GS­
00014:
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3,
1980.

GS­
00015:
Lindane
Position
Document
4,
1984.

GS­
00016:
R.
W.
Chadwick,
et
al.
"Enhanced
Pesticide
Metabolism,
a
Previously
Unreported
Effect
of
Dietary
Fibre
in
Mammals."
Fd.
Cosmet.
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217­
225
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GS­
00017:
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C.,
et
al.
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Residue
in
Chickens
and
Eggs
Following
Poultry
House
Spray,"
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54(
3):
487­
488
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GS­
00018:
BHC­
Lindane
Report,
Special
Pesticide
Review
group.

GS­
00019
(Section
18
Exemption
for
the
use
of
lindane
on
sugarcane
in
Puerto
Rico,
4/
14/
80).

GS­
00021:
PP
#058,
Acc.
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113144.

GS­
00022:
No
citation
available
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00023:
Oehler,
D.
D.,
et
al.
"Residues
in
Milk
Following
Treatment
of
Cows
with
Lindane
or
Ronnel
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Screw­
worms,"
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Entomol.,
63,
1467
(1970).
