Document ID: EPA-HQ-OPP-2002-0202-0004
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2002-08-14T04:00Z

December
13,
2001
MEMORANDUM
SUBJECT:
Lindane
(009001)
Reregistration
Case
No.
0315.
Revised
Anticipated
Residues,
Acute
and
Chronic
Dietary
Exposure
and
Risk
Analyses
for
the
HED
Human
Health
Risk
Assessment.
DP
Barcode
D279260.

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

THROUGH:
David
Soderberg,
Chemist
Sheila
Piper,
Chemist
Dietary
Exposure
Science
Advisory
Council
and
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)

Action
Requested
Prepare
the
revised
anticipated
residues
and
acute,
chronic,
and
cancer
dietary
exposure
and
risk
analyses
for
lindane
(009001)
incorporating
comments
from
the
public
and
deleting
seed
treatment
uses
on
broccoli,
Brussels
sprouts,
cabbage,
cauliflower,
lettuce,
radishes,
and
spinach
which
are
no
longer
being
supported
for
reregistration
by
Inquinosa.
The
OPP/
Cancer
Assessment
Review
Committee
(CARC)
has
completed
the
reviewof
newlysubmitted
carcinogenicitystudyinCD­
1
mice
2
along
with
other
data.
In
accordance
with
the
EPADraft
Guidelines
for
Carcinogen
Risk
Assessment
(July,
1999),
the
CARC
has
classified
lindane
into
the
category
"Suggestive
evidence
of
carcinogenicity,
but
not
sufficient
to
assess
human
carcinogenic
potential"
based
on
an
increased
incidence
of
benign
lung
tumors
in
female
mice
only.
The
Committee,
therefore,
recommended
that
the
quantification
of
human
cancer
risk
is
not
required.

Executive
Summary
°
Estimated
acute
dietary
exposure
is
below
HED's
level
of
concern
for
all
population
subgroups
at
the
99.9
th
percentile.
The
maximum
dietary
risk
estimate
is
17
%
of
the
acute
PAD
(%
aPAD)
for
the
population
subgroup
All
Infants
(Table
18)
and
7
%
of
the
aPAD
for
the
U.
S.
Population
when
the
feeding
studies
were
adjusted
using
the
metabolism
studies.

°
Estimated
chronic
dietary
risk
is
below
HED's
level
of
concern
for
all
population
subgroups.
The
resulting
risk
estimates
are
3
%
of
the
chronic
PAD
(%
cPAD)
for
the
U.
S.
Population
and
11
%
of
the
cPAD
for
Children
1­
6
years
of
age
(highest
exposed
population
subgroup)
and
6
%
of
the
cPAD
for
Children
7­
12
yrs.
The
remaining
population
subgroups
were

5
%of
the
cPAD(
Table
18)
when
the
feeding
studies
were
adjusted
using
the
ratio
of
ppm
TRR/
ppm
lindane
identified
in
the
metabolism
studies
(Table
18).

Toxicological
Information
Memoranda
providing
details
of
relevant
toxicological
information
include
the
HIARC
report
dated
7/
27/
00
and
the
FQPA
Safety
Factor
Committee
report
dated
8/
2/
00.

The
acute
and
chronic
FQPA
safety
factors
of
10X
were
reduced
to
3X
(see
FQPA
Safety
Factor
Document,
8/
2/
00).
Areference
dose
(RfD)
which
includes
the
FQPA
safety
factor
(10X,
3Xor
1X)
is
defined
as
the
Population
Adjusted
Dose
(PAD).
Doses
and
endpoints
for
dietary
risk
assessment
are
presented
in
Table
1.

The
OPP/
Cancer
Assessment
Review
Committee
(CARC)
has
completed
the
review
of
newly
submitted
carcinogenicity
study
in
CD­
1
mice
along
with
other
data.
In
accordance
with
the
EPA
Draft
Guidelines
for
Carcinogen
Risk
Assessment
(July,
1999),
the
CARC
has
classified
lindane
into
the
category
"Suggestive
evidence
of
carcinogenicity,
but
not
sufficient
to
assess
human
carcinogenic
potential"
based
on
an
increased
incidence
of
benign
lung
tumors
in
female
mice
only.
The
Committee,
therefore,
recommended
that
the
quantification
of
human
cancer
risk
is
not
required.
3
Table
1.
Lindane:
Toxicological
Doses
and
Endpoints
for
Dietary
Risk
Assessment.

EXPOSURE
SCENARIO
DOSE
(mg/
kg/
day)
ENDPOINT
STUDY
TYPE/
MRID
Acute
Dietary­
general
population
NOAEL=
6
mg/
kg
UF
=
100
FQPA
=
3X
LOAELis20
mg/
kgbased
on
increasedgrip
strength,
increased
Motor
Activity
Acute
Neurotoxicity
in
Rats/
44769201
Acute
RfD
(Gen.
Pop.)
=
0.
06
mg/
kg/
day
Acute
Population
Adjusted
Dose
(aPAD)
=
0.
02
mg/
kg/
day
Chronic
Dietary
NOAEL=
10
ppm
(0.
47
mg/
kg/
day)

UF
=
100
FQPA
=
3X
LOAEL
is
100
ppm
(4.
81
mg/
kg/
day)
periacinar
hepatocyte
hypertrophy,
increased
liver/
spleen
weight,
and
increased
platelets
Chronic
Feeding
and
Carcinogenicity
in
Rats
41094101
41853701
42891201
Chronic
RfD
=
0.
0047
mg/
kg/
day
Chronic
Population
Adjusted
Dose
(cPAD)
=
0.
0016
mg/
kg/
day
Consumption
Data
HED
conducts
dietary
risk
assessments
using
the
Dietary
Exposure
Evaluation
Model
(DEEM™),
which
incorporates
consumption
data
generated
in
USDA's
Continuing
Surveys
of
Food
Intakes
by
Individuals
(CSFII),
1989­
1992.
For
acute
dietary
risk
assessments,
the
entire
distribution
of
single
day
food
consumption
events
is
combined
with
either
a
single
residue
level
(deterministic
analysis,
risk
at
95th
percentile
of
exposure
reported)
or
a
distribution
of
residues
(probabilistic
analysis,
referred
to
as
"Monte
Carlo,"
with
risk
at
99.
9th
percentile
of
exposure
reported)
to
obtain
a
distribution
of
exposures
in
mg/
kg/
day.
For
chronic
dietary
risk
assessments,
the
three­
day
average
of
consumption
for
each
sub­
population
is
combined
with
average
residues
in/
on
commodities
to
determine
an
average
exposure
in
mg/
kg/
day.

Residue
Information
Tolerances
for
residues
of
lindane
in/
on
food
and
feed
commodities
are
currently
established
under
40
CFR
§180.133
and
are
expressed
in
terms
of
lindane
per
se.
The
nature
of
the
residue
in
plants
and
ruminants
is
not
adequately
understood.
New
nature
of
the
residue
studies
fromseed
treatment
are
required
for
a
cereal
grain,
leafy
vegetable,
and
radish.
Additional
data
are
required
for
the
ruminant
metabolismstudy.
The
nature
ofthe
residue
in
poultry
is
adequately
understood.
The
HED
MetabolismAssessment
ReviewCommittee(T.
Morton,
8/
30/
00,
D267069)
concluded
that
theTRRs
should
be
used
for
risk
assessment
purposes
and
calculation
of
dietary
burdens,
pending
receipt
of
additional
metabolismdata.
The
anticipated
residues
(ARs)
were
presented
to
the
HED
ChemSAC
on
9/
6/
00.
Exposure
to
lindane
was
determined
by
using
the
ratio
(ppm
TRR/
ppm
lindane
parent)
fromthelivestock
metabolismstudies.
TheBiologicaland
EconomicAnalysisDivision
(OPP/
BEAD)
verified
the
registrant's
percent
market
share
estimate
for
lindane
(I.
Yusuf
email,
7/
17/
00).
The
usage
data
are
provided
as
Attachment
1;
inclusion
of
the
data
in
dietary
exposure
analyses
is
discussed
below.
Acanola
processing
studyfor
lindane
wasrecentlyreviewed
(T.
Morton,
D269388,
5/
10/
01).
Lindane
was
not
detected
in
bleached/
deodorized
canola
oil
(<
0.005
ppm).
Therefore,
½
4
LOQ
(0.0025
ppm)
will
be
used
as
the
DEEM™
adjustment
factor
1.
DEEM™
default
concentrations
factors
(adjustment
factor
1)
will
be
used
for
all
other
concentration
factors.
The
wheat
grain
and
forage
TRRs
were
translated
to
barley,
oats,
and
rye.
The
corn
grain
and
forage
TRRs
were
translated
to
sorghum.

The
following
metabolism
and
feeding
studies
were
used
to
determine
the
appropriate
residue
values
to
be
used
in
both
the
dietary
burden
calculation
and
the
DEEM™
input
files.

Seed
Treatment
Metabolism
Study
(N.
Dodd,
3/
24/
88,
RCB
3259,
MRID
40431207)

Various
seeds
were
treated
with
14
C
lindane.
Spring
wheat
seeds
were
treated
at
370
ppm
(0.
3x),
field
corn
seeds
at
1800
ppm
(0.
8x),
and
sweet
corn
seeds
at
1400
ppm
(0.
6x).
Seeds
were
then
planted
outdoors.
Samples
were
analyzed
for
radioactivity
periodically
by
oxidative
combustion
and
autoradiography.
Samples
were
extracted
and
analyzed
for
14
C
by
liquid
scintillation
counting
(LSC)
and
for
lindane
by
gas
liquid
chromatography
(GLC)
when
significant
residues
were
found
by
combustion.
This
study
was
deemed
inadequate
due
to
insufficient
characterization/
identification
of
the
radioactive
residues.
A
new
nature
of
the
residue
study
from
seed
treatment
is
required
for
a
cereal
grain.
The
HED
MARC
(T.
Morton,
8/
30/
00,
D267069)
concluded
that
the
TRRs
should
be
used
for
calculation
of
dietary
burdens.
The
TRRs
are
summarized
in
the
following
table.

Table
2.
Summary
of
TRR
in
various
crops
after
seed
treatment
with
14
C
labeled
lindane.

Crop
Matrix
TRR
(ppm)

Field
corn
root
0.
340
Field
corn
foliage
0.064
Field
corn
grain
<
0.
01
Sweet
corn
foliage
0.051
Sweet
corn
grain
<
0.01
Wheat
foliage
2.925
Wheat
grain
0.052
The
TRR
used
for
barley,
canola,
oats,
rye,
and
wheat
grain
was
0.052
ppm.
The
TRR
value
used
for
corn
grain
and
sorghum
grain
was
0.01
ppm.

Meat,
Milk,
Poultry,
&
Eggs
5
The
following
acute
dietary
burdens
(Table
3)
were
calculated
using
the
appropriate
TRRs
fromthe
seed
treatment
metabolism
study
presented
in
the
previous
table
(Table
2).
The
chronic
dietary
burdens
(Table
4)
have
incorporated
the
percent
market
share
of
the
feed
item
into
the
dietary
contribution.

Table
3.
Lindane
Acute
Dietary
Burden.
6
Feed
Commodity
%
Dry
Matter
%
Diet
Anticipated
Residue
(ppm)
Dietary
Contribution
(ppm)

Beef
Cattle
Field
corn
grain
88
50
0.01
0.0057
Wheat
forage
25
25
2.
925
2.925
Sorghum
forage
35
15
0.
064
0.028
Wheat
grain
89
10
0.052
0.006
Total
100
2.96
Dairy
Cattle
Field
corn
grain
88
40
0.01
0.0045
Wheat
grain
89
10
0.052
0.006
Wheat
forage
25
50
2.
925
5.85
Total
100
5.86
Poultry
Field
corn
grain
NA
20
0.01
0.002
Wheat
grain
NA
80
0.052
0.0416
Total
100
0.044
Swine
Field
corn
grain
NA
20
0.01
0.002
Wheat
grain
NA
80
0.052
0.0416
Total
100
0.044
Table
4.
Lindane
Chronic
Dietary
Burden.
7
Feed
Commodity
%
Dry
Matter
%
Diet
Anticipated
Residue
(ppm)
Percent
Market
Share
Dietary
Contribution
(ppm)

Beef
Cattle
Field
corn
grain
88
50
0.01
0.15
0.0009
Wheat
forage
25
25
2.
925
0.03
0.0878
Sorghum
forage
35
15
0.
064
0.03
0.0008
Wheat
grain
89
10
0.052
0.03
0.0002
Total
100
0.0897
Dairy
Cattle
Field
corn
grain
88
40
0.01
0.15
0.0007
Wheat
grain
89
10
0.052
0.03
0.0002
Wheat
forage
25
50
2.
925
0.03
0.1755
Total
100
0.1764
Poultry
Field
corn
grain
NA
20
0.01
0.15
0.0003
Wheat
grain
NA
80
0.052
0.03
0.0012
Total
100
0.0015
Swine
Field
corn
grain
NA
20
0.01
0.15
0.0003
Wheat
grain
NA
80
0.052
0.03
0.0012
Total
100
0.0015
Ruminant
Metabolism
Study
(MRID
44867104)
8
Lactating
goats
were
orally
administered
14
C­
Lindane
capsules
(via
balling
gun)
immediately
after
the
morning
milking
once
per
day
for
7
days.
The
actual
dose
rat
e
was
13
mg/
kg.
This
dose
rate
is
equivalent
to
approximately
a
2x
exaggerated
rate
for
dairy
cattle
and
approximately
4.4x
for
beef
cattle
based
on
an
acute
dietary
burden
as
calculated
by
HED.
The
acute
anticipated
residues
using
the
TRR
alone
for
cattle
and
swine
are
summarized
in
Table
6
and
7.
The
chronic
anticipated
residues
usingthe
TRRalone
forcattle
andswine
aresummarizedinTable
8
and
9.

Table
5.
Summary
of
TRR
characterized/
identified
in
tissues
of
lactating
goats
orally
dosed
with
14
C­
Lindane
at
13
ppm.

Tissue
Total
Radioactive
Residue
(TRR)
ppm
Fat
3.
46
ppm
Liver
2.
25
ppm
Kidney
0.
48
ppm
Muscle
0.20
ppm
Milk
Fat
0.
136
ppm
Table
6.
Cattle
Acute
Anticipated
Residues
From
Nature
of
the
residue
study
(M.
Kovacs
Jr.,
9/
20/
88,
RCB
4037).

Tissue
13
ppm
Feeding
Level
(4.
4X)
a
Cattle
AR
Fat
3.
46/
4.4=
0.786
0.786
ppm
Muscle
0.2/
4.4=
0.045
0.045
ppm
Milk
Fat
0.
136/
2=
0.068
0.068
ppm
Liver
2.
25/
4.4=
0.511
0.511
ppm
b
Kidney
0.48/
4.4=
0.109
0.109
ppm
a
The
13
ppm
feeding
level
represented
2x
the
dairy
dietary
burden.
b
Use
for
liver,
meat
byproducts,
and
other
organ
meats
for
beef,
goat,
horses,
sheep,
and
veal.

Table
7.
Swine
Acute
Anticipated
Residues
based
on
metabolism
data
from
the
ruminant
metabolism
study.

Tissue
13
ppm
Feeding
Level
(295X)
Swine
AR
Fat
3.
46/
295=
0.012
0.012
ppm
Muscle
0.2/
295=
0.001
0.001
ppm
Liver
2.
25/
295=
0.008
0.008
ppm
a
Kidney
0.48/
295=
0.002
0.002
ppm
a
Use
for
liver,
meat
byproducts,
and
other
organ
meats
for
pork.

Table
8.
Cattle
Chronic
Anticipated
Residues
From
Nature
of
the
residue
study
(M.
Kovacs
Jr.,
9/
20/
88,
RCB
4037).
9
Tissue
13
ppm
Feeding
Level
(145X)
a
Cattle
AR
Fat
3.
46/
145=
0.02
0.02
ppm
Muscle
0.2/
145=
0.001
0.001
ppm
Milk
Fat
0.
136/
74=
0.002
0.002
ppm
Liver
2.
25/
145=
0.02
0.02
ppm
b
Kidney
0.48/
145=
0.003
0.003
ppm
a
The
13
ppm
feeding
level
represented
74x
the
chronic
dairy
dietary
burden.
b
Use
for
liver,
meat
byproducts,
and
other
organ
meats
for
beef,
goat,
horses,
sheep,
and
veal.

Table
9.
Swine
Chronic
Anticipated
Residues
based
on
metabolism
data
from
the
ruminant
metabolism
study.

Tissue
13
ppm
Feeding
Level
(8700X)
Swine
AR
Fat
3.
46/
8700=
0.0004
0.0004
ppm
Muscle
0.2/
8700=
0.00002
0.00002
ppm
Liver
2.
25/
8700=
0.0003
0.0003
ppm
a
Kidney
0.48/
8700=
0.00006
0.00006
ppm
a
Use
for
liver,
meat
byproducts,
and
other
organ
meats
for
pork.

Poultry
Metabolism
Study
(MRID
40271301)

Following
4
days
of
dosing
with
[
14
C]
lindane
at
levels
equivalent
to
120
(2700x)
ppm
in
the
acute
diet,
14
C­
residues
accumulated
to
the
greatest
extent
in
fatty
tissues.
In
the
high­
dose
hens,
TRRs
were
highest
in
fat
(96.98
ppm)
followed
by
skin
(49.93
ppm),
thigh
muscle
(11.81
ppm),
liver
(11.65
ppm),
and
breast
muscle
(1.44
ppm).

14
C­
Residues
were
readily
extracted
(80­
141%
TRR)
fromyolks,
thigh
muscle,
liver,
skin,
and
fat
of
high­
dose
hens
using
organic
solvents,
and
66.4­
121.3%
of
the
TRR
was
subsequently
identified.
Lindane
was
the
principal
14
C­
residue
identified
in
eggs
and
tissues,
accounting
for
94.5%
of
the
TRR
in
egg
yolks,
70.8­
86.0%
of
the
TRR
in
muscle,
skin,
and
fat,
and
51.5%
of
the
TRR
in
liver.
1,
2,
4Trichlorobenzene
was
identified
as
accounting
for
19.4%
of
the
TRR
in
liver,
and
0.6­
3.5%
of
the
TRR
in
egg
yolks
and
other
tissues.
1,
3,
5­
Trichlorobenzene
and
dichlorobenzene(
s)
were
also
detected
in
liver
at
6.4
and
9.5%
of
the
TRR,
respectively.
Tetrachlorobenzene
(either
1,2,4,5­
or
1,2,3,4­)
was
detected
in
thigh
muscle
at
17.7%
of
the
TRR
and
in
other
tissues
at
2.2­
3.1%
of
the
TRR.
Pentachlorocyclohexene
was
identified
as
accounting
for
3.
8­
6.
1%
of
the
TRR
in
yolks
and
tissues.
The
remaining
metabolites
(1,
2,
3,
4­
tetrachlorobenzene/
tetrachlorocyclohexene;
1,2,3,4,5­
pentachlorobenzene;
and
hexachlorocyclohexene)
detected
intissues
and/
or
yolks
each
accounted
for

4.4%
of
the
TRR.
The
acute
anticipated
residues
using
the
TRR
alone
for
poultry
are
summarized
in
Table
10.
The
chronic
anticipated
residues
using
the
TRR
alone
for
poultry
are
summarized
in
Table
11.
10
Table
10.
Summary
of
TRR
characterized/
identified
in
tissues
of
laying
hens
orally
dosed
with
14
C­
Lindane
at
120
ppm
(2700x
acute
dietary
burden)
normalized
to
1x
the
acute
dietary
burden.

Tissue
Total
Radioactive
Residue
(TRR)
ppm
Acute
Anticipated
Residue
(ppm)

Fat
97.0
ppm/
2700=
0.04
0.04
Liver
11.7
ppm/
2700=
0.004
0.004
Skin
49.9
ppm/
2700=
0.02
0.02*

Thigh
11.8
ppm/
2700=
0.004
0.004
Egg
White
0.21/
2700=
0.00008
0.00008
Egg
Yolk
10.8
ppm/
2700=
0.004
0.004
Whole
Egg
0.7(
0.00008)+
0.
3(
0.
004)=
0.
001
*Use
for
poultry
meat
byproducts
Table
11.
Summary
of
TRR
characterized/
identified
in
tissues
of
laying
hens
orally
dosed
with
14
C­
Lindane
at
120
ppm
(80000x
acute
dietary
burden)
normalized
to
1x
the
chronic
dietary
burden.

Tissue
Total
Radioactive
Residue
(TRR)
ppm
Chronic
Anticipated
Residue
(ppm)

Fat
97.0
ppm/
80000=
0.001
0.001
Liver
11.7
ppm/
80000=
0.0001
0.0001
Skin
49.9
ppm/
80000=
0.0006
0.0006*

Thigh
11.8
ppm/
80000=
0.0001
0.0001
Egg
White
0.21/
80000=
0.000003
0.000003
Egg
Yolk
10.8
ppm/
80000
0.0001
Whole
Egg
0.7(
0.000003)+
0.
3(
0.
0001)=
0.
00003
*Use
for
poultry
meat
byproducts
Ruminant
Feeding
Study
(M.
Kovacs
Jr.,
9/
20/
88,
RCB
4037)

Dairy
cattle
were
fed
at
three
feeding
levels
of
20
ppm(
6.
7x
acute
beef
cattle
dietary
burden),
60
ppm
(20x
acute
beef
cattle
dietary
burden),
and
200
ppm
(67x
acute
beef
cattle
dietary
burden).
The
exaggerated
feeding
rates
correspond
to
3.
4x,
10x,
and
34x
for
the
acute
dairy
cattle
dietary
burden,
respectively.
The
exaggerated
feeding
rates
correspond
to
450x,
1400x,
and
4500x
for
the
acute
swine
dietary
burden,
respectively.
The
acute
anticipated
residues
for
cattle
and
swine
using
the
feeding
studies
along
with
information
fromthe
metabolismstudies
are
summarized
in
Tables
12
and
13.
The
chronic
anticipated
residues
for
cattle
and
swine
using
the
feeding
studies
along
with
information
from
the
metabolism
studies
are
summarized
in
Tables
14
and
15.

Table
12.
Summary
of
lindane
residues
in
cattle
fed
at
20,
60,
and
200
ppm
normalized
to
a
1x
acute
feeding
level.
11
Sample
20
ppm
(6.7x)
a
60
ppm
(20x)
a
200
ppm
(67x)
a
Average
(ppm)
*
(ppm
TRR/
ppm
lindane)
b
Milk
(Day
7)
0.41/
3.4
=
0.120
1.64/
10
=
0.
164
3.95/
34
=
0.
116
0.133
*
1.
22
=
0.163
Liver
0.
10/
6.7
=
0.015
0.19/
20
=
0.
009
0.72/
67
=
0.
011
0.012
*
6.
25
=
0.073
Kidney
0.34/
6.7
=
0.051
1.07/
20
=
0.
053
4.57/
67
=
0.
068
0.057
*
2.
82
=
0.162
Muscle
0.97/
6.7
=
0.145
1.80/
20
=
0.
090
8.75/
67
=
0.
130
0.122
*
1.
25
=
0.152
Fat
11.9/
6.7
=
1.78
20.2/
20
=
1.
01
58.1/
67
=
0.
87
1.
22
*
1.
18
=
1.44
a
First
number
in
column
is
residue
value
from
feeding
study
which
is
then
divided
by
the
exaggerated
feeding
rate.
b
Average
residue
value
from
three
feeding
levels
multiplied
by
the
ratio
of
(ppm
TRR/
ppm
lindane)
in
metabolism
study.

Table
13.
Summary
of
lindane
residues
in
swine
translated
from
the
cattle
feeding
study
and
normalized
to
1x
acute
feeding
level.

Sample
20
ppm
(450x)
a
60
ppm
(1400x)
a
200
ppm
(4500x)
a
Average
(ppm)
*
(ppm
TRR/
ppm
lindane)
b
Liver
0.
10/
450=
0.0002
0.19/
1400=
0.0001
0.72/
4500=
0.0002
0.0002
*
6.
25
=
0.001
Kidney
0.34/
450=
0.0007
1.07/
1400=
0.0008
4.57/
4500=
0.001
0.0008
*
2.
82
=
0.002
Muscle
0.97/
450=
0.002
1.80/
1400=
0.001
8.75/
4500=
0.002
0.002
*
1.
25
=
0.002
Fat
11.9/
450=
0.026
20.2/
1400=
0.014
58.1/
4500=
0.013
0.018
*
1.
18
=
0.021
a
First
number
in
column
is
residue
value
from
feeding
study
which
is
then
divided
by
the
exaggerated
feeding
rate.
b
Average
residue
value
from
three
feeding
levels
multiplied
by
the
ratio
of
(ppm
TRR/
ppm
lindane)
in
metabolism
study.

Table
14.
Summary
of
lindane
residues
in
cattle
fed
at
20,
60,
and
200
ppm
normalized
to
a
1x
chronic
feeding
level.

Sample
20
ppm
(223x)
a
60
ppm
(669x)
a
200ppm(
2230x)
a
Average
(ppm)
*
(ppm
TRR/
ppm
lindane)
b
Milk
(Day
7)
0.41/
113=
0.004
1.64/
340=
0.005
3.95/
1134=
0.003
0.004
*
1.
22
=
0.005
Liver
0.
10/
223=
0.0004
0.19/
669=
0.0003
0.72/
2230=
0.0003
0.0003
*
6.
25
=
0.002
Kidney
0.
34/
223=
0.002
1.07/
669=
0.002
4.57/
2230=
0.002
0.002
*
2.
82
=
0.006
Muscle
0.97/
223=
0.004
1.80/
669=
0.003
8.75/
2230=
0.004
0.004
*
1.
25
=
0.005
Fat
11.9/
223=
0.05
20.2/
669=
0.03
58.1/
2230=
0.03
0.04
*
1.
18
=
0.05
a
First
number
in
column
is
residue
value
from
feeding
study
which
is
then
divided
by
the
exaggerated
feeding
rate.
b
Average
residue
value
from
three
feeding
levels
multiplied
by
the
ratio
of
(ppm
TRR/
ppm
lindane)
in
metabolism
study.

Table
15.
Summary
of
lindane
residues
in
swine
translated
fromthe
cattle
feeding
study
and
normalized
to
1x
chronic
12
feeding
level.

Sample
20
ppm
(13300x)
a
60
ppm
(40000x)
a
200
ppm
(133000x)
a
Average
(ppm)
*
(ppm
TRR/
ppm
lindane)
b
Liver
0.
10/
13300=
0.000
008
0.19/
40000=
0.0000
05
0.72/
133000=
0.000005
0.000006
*
6.
25
=
0.00004
Kidney
0.34/
13300=
0.000
03
1.07/
40000=
0.0000
3
4.57/
133000=
0.00003
0.00003
*
2.
82
=
0.00008
Muscle
0.97/
13300=
0.000
07
1.80/
40000=
0.0000
5
8.75/
133000=
0.00007
0.00006
*
1.
25
=
0.00008
Fat
11.9/
13300=
0.000
9
20.2/
40000=
0.0005
58.1/
133000=
0.0004
0.0006
*
1.
18
=
0.0007
a
First
number
in
column
is
residue
value
from
feeding
study
which
is
then
divided
by
the
exaggerated
feeding
rate.
b
Average
residue
value
from
three
feeding
levels
multiplied
by
the
ratio
of
(ppm
TRR/
ppm
lindane)
in
metabolism
study.

Poultry
Feeding
Study
(G.
Otakie,
8/
31/
88,
RCB
4034)

Poultry
were
fed
lindane
at
1.5
(34x
the
acute
dietary
burden),
4.
5
(102x
the
acute
dietary
burden),
and
15
(340x
the
acute
dietary
burden)
ppmfeeding
levels.
The
acute
anticipated
residues
for
poultry
using
the
feeding
study
along
with
information
from
the
metabolism
study
are
summarized
in
Table
16.
The
chronic
anticipated
residues
for
poultry
using
the
feeding
study
along
with
information
from
the
metabolism
study
are
summarized
in
Table
17.

Table
16.
Summary
of
lindane
residues
in
poultry
fed
at
1.5,
4.5,
and
15
ppm
normalized
to
a
1x
acute
feeding
level.

Sample
1.5
ppm
(34x)
a
4.5
ppm
(102x)
a
15
ppm
(340x)
a
Average
(ppm)
*
(ppm
TRR/
ppm
lindane)
b
Eggs
0.216/
34
=
0.
006
0.672/
102
=
0.
006
2.357/
340
=
0.
007
0.006
*
1.
06
=
0.006
Liver
0.
12/
34
=
0.
003
0.51/
102
=
0.
005
0.78/
340
=
0.
002
0.003
*
1.
95
=
0.006
Heart
0.
33/
34=
0.
010
0.
89/
102=
0.
009
2.
26/
340=
0.
007
0.
009
*1
=0.
009
c
Thigh
0.
19/
34
=
0.
005
0.36/
102
=
0.
003
1.35/
340
=
0.
004
0.004
*
1.
40
=
0.006
Fat
2.
54/
34
=
0.
075
7.8/
102
=
0.
076
27.7/
340
=
0.
081
0.077
*
1.
17
=
0.090
a
First
number
in
column
is
residue
value
from
feeding
study
which
is
then
divided
by
the
exaggerated
feeding
rate.
b
Average
residue
value
from
three
feeding
levels
multiplied
by
the
ratio
of
(ppm
TRR/
ppm
lindane)
in
metabolism
study.
c
100%
of
the
TRR
in
the
chicken
heart
was
identified
as
lindane.
This
residue
was
used
for
chicken
byproducts,
chicken
giblets
(excl.
liver),
turkey
byproducts,
turkey
other
organ
meats,
and
turkey
giblets
(excl.
liver).

Table
17.
Summaryof
lindane
residues
in
poultry
fed
at
1.5,
4.5,
and
15
ppm
normalized
to
a
1x
chronic
feeding
level.
13
Sample
1.5
ppm
(1000x)
a
4.5
ppm
(3000x)
a
15
ppm
(10000x)
a
Average
(ppm)
*
(ppm
TRR/
ppm
lindane)
b
Eggs
0.216/
1000=
0.0002
0.672/
3000=
0.0002
2.357/
10000=
0.0002
0.002
*
1.
06
=
0.0002
Liver
0.
12/
1000=
0.0001
0.51/
3000=
0.0002
0.78/
10000=
0.00008
0.0001
*
1.
95
=
0.0002
Heart
0.
33/
1000=
0.0003
0.89/
3000=
0.0003
2.26/
10000=
0.0002
0.0003
*1
=0.
0003
c
Thigh
0.
19/
1000=
0.0002
0.36/
3000=
0.0001
1.35/
10000=
0.0001
0.0001
*
1.
40
=
0.0002
Fat
2.
54/
1000=
0.003
7.8/
3000=
0.003
27.7/
10000=
0.003
0.003
*
1.
17
=
0.004
a
First
number
in
column
is
residue
value
from
feeding
study
which
is
then
divided
by
the
exaggerated
feeding
rate.
b
Average
residue
value
from
three
feeding
levels
multiplied
by
the
ratio
of
(ppm
TRR/
ppm
lindane)
in
metabolism
study.
c
100%
of
the
TRR
in
the
chicken
heart
was
identified
as
lindane.
This
residue
was
used
for
chicken
byproducts,
chicken
giblets
(excl.
liver),
turkey
byproducts,
turkey
other
organ
meats,
and
turkey
giblets
(excl.
liver).

Uncertainties
There
are
no
adequate
nature
of
the
residue
studies
for
plants
fromseed
treatment
application.
Anew
metabolism
study
is
required
for
a
grain
crop;
however,
a
seed
treatment
metabolism
study
(which
was
classified
as
inadequate)
was
reviewed
by
HED
and
used
in
the
determination
of
the
TRR
for
use
in
this
dietary
exposure
analysis.
The
wheat
grain
and
forage
TRRs
were
translated
to
barley,
oats,
and
rye.
The
corn
grain
and
forage
TRRs
were
translated
to
sorghum.
The
nature
of
the
residue
in
poultry
is
understood.
The
nature
of
the
residue
in
livestock
is
adequately
understood.
The
magnitude
of
the
residue
studies
in
poultry
and
cattle
only
analyzed
for
lindane.
The
lindane
residue
values
were
derived
using
a
ratio
of
total
radioactive
residue
divided
by
the
amount
of
lindane
present
in
the
livestock
metabolism
studies.
This
would
be
worst
case
estimate
since
we
are
assuming
that
all
of
the
TRR
would
be
residues
of
concern
and
adjusting
the
lindane
residues
in
the
livestock
magnitude
of
the
residue
studies
accordingly
to
account
for
the
TRR.

The
dietaryexposure
analyses
using
the
total
radioactive
residues
is
a
Tier
3
assessment
since
percent
crop
treated
was
used
in
the
analyses.
The
dietary
exposure
analyses
that
were
based
on
the
adjustment
of
the
lindane
residues
in
the
feeding
studies
is
a
Tier
3
assessment.
Percent
market
share
was
available
for
all
crops
included
in
the
analyses.
Since
lindane
is
being
supported
for
reregistration
for
seed
treatments
only,
there
is
no
difference
in
the
percent
crop
treated
values
between
crops
grown
for
the
fresh
market
and
those
grown
for
processing.
A
processing
study
was
available
for
canola
only;
the
default
DEEM™
processing
factors
were
used
for
all
other
foods.

Results/
Discussion
14
Estimated
acute
dietary
exposure
is
below
HED's
level
of
concern
for
all
population
subgroups
at
the
99.9
th
percentile.
The
maximum
dietary
risk
estimate
is
17
%
of
the
aPAD
for
All
Infants
when
the
feeding
studies
were
adjusted
using
the
metabolism
studies
(Table
18).

Estimated
chronic
dietary
risk
is
below
HED's
level
of
concern
for
all
population
subgroups.
The
resulting
risk
estimates
are
3
%
of
the
chronic
PAD
(%
cPAD)
for
the
U.
S.
Population
and
11
%
of
the
cPADfor
Children
1­
6
years
of
age
(highest
exposed
population
subgroup)
and
6
%of
the
cPAD
for
Children
7­
12
yrs.
The
remaining
population
subgroups
were

5%
ofthe
cPAD
(Table
18)
when
the
feeding
studies
were
adjusted
using
the
ratio
of
ppm
TRR/
ppm
lindane
identified
in
the
metabolism
studies
(Table
18).

Table
18.
Estimated
Acute
and
Chronic
Dietary
Exposure
and
Risk
using
the
feeding
studies
and
adjusting
lindane
residues
using
the
metabolism
studies.

Population
Subgroup
Acute
(99.9th
%­
ile)
Chronic
Exposure
(mg/
kg/
day)
%aPAD
Exposure
(mg/
kg/
day)
%
cPAD
U.
S.
Population
0.
001305
7
0.
000054
3
All
infants
(<
1
yr)
0.003320
17
0.000072
5
Children
(1­
6
yrs)
0.
001973
10
0.000173
11
Children
(7­
12
yrs)
0.001088
5
0.
000096
6
Females
(13­
50
yrs)
0.000467
2
0.
000034
2
Males
(13­
19
yrs)
0.000670
3
0.
000061
4
Males
(20+
yrs)
0.000458
2
0.
000034
2
Seniors
(55+
yrs)
0.000409
2
0.
000030
2
cc
:
Chem
F,
Chron
F.
Morton
,
L.
Richardson
RDI:
Chemistry
SAC
(9/
6/
00);
DE
SAC
(9/
25/
00)
(S.
Piper,
12/
13/
01
&
D.
Soderberg,
12/
13/
01);
SVH:
12/
13/
01
TM,
Thurston
Morton,
Rm.
816D
CM2,
305­
6691,
mail
code
7509C
List
of
Attachments:
Attachment
1:
Quantitative
Usage
Analysis,
7/
17/
00
(I.
Yusuf,
BEAD/
OPP).
Attachment
2:
Residue
Distribution
Files.
Attachment
3:
Residue
Information.
Attachment
4:
Acute
Analysis.
Attachment
5:
Chronic
Analysis.

Attachment
1:
Quantitative
Usage
Analysis,
7/
17/
00
(I.
Yusuf,
BEAD/
OPP).

(Registrant
submission
approved
by
BEAD)
15
From
the
Small
Grains
petition,
Page
79.

B.
Market
share
representing
maximum
percent
of
crop
treated
is
15%
for
field
corn,
10%
for
canola,
1%
for
sweet
corn,
and
3%
each
for
wheat,
oats,
barley,
and
grain
sorghum.

From
the
Small
Grains
petition,
Page
35
MARKET
SHARE
Reasonable
estimates
for
the
percentage
of
seeds
of
wheat,
barley,
oats,
rye,
and
sorghum
treated
with
lindane
i.
e.,
the
market
share,
are
1%
to
3%.
The
market
share
on
corn
may
be
as
high
as
15%.
Market
share
information
was
used
in
calculations
of
Maximum
Theoretical
Dietary
Burdens
for
livestock,
and
was
considered
in
some
estimations
of
human
dietary
exposure.

From
the
vegetables
petition,
Page
22.

MARKET
SHARE:

Reasonable
estimates
for
the
percentage
of
acres
employing
lindane­
treated
seeds
are:
corn
15%,
brassica
<
1%,
leafy
vegetables
<
1%,
and
radishes
<
1%.
(Personal
Communication:
T.
McArtle,
Trace
Chemical
and
Seed
Treatment
Coalition
representative,
December
1998).

Attachment
2:
RDFs
Documentation:
doc
beef
fat
lindane
DOC
ASSUMING
15%
crop
treated
for
highest
feed
item
TOTALZ=
85
16
TOTALFREQ=
1
15,1.44
Documentation:
doc
beef
meat
lindane
DOC
ASSUMING
15%
crop
treated
for
highest
feed
item
TOTALZ=
85
TOTALFREQ=
1
15,0.152
Documentation:
doc
beef
meat
by
products
lindane
DOC
ASSUMING
15%
crop
treated
for
highest
feed
item
TOTALZ=
85
TOTALFREQ=
1
15,0.162
Documentation:
doc
beef
liver
lindane
DOC
ASSUMING
15%
crop
treated
for
highest
feed
item
TOTALZ=
85
TOTALFREQ=
1
15,0.073
Documentation:
doc
milk
lindane
DOC
ASSUMING
15%
crop
treated
for
highest
feed
item
TOTALZ=
85
TOTALFREQ=
1
15,0.163
Documentation:
doc
poultry
eggs
lindane
DOC
ASSUMING
15%
crop
treated
for
highest
feed
item
TOTALZ=
85
TOTALFREQ=
1
15,0.006
Documentation:
doc
poultry
meat
byproducts
lindane
DOC
ASSUMING
15%
crop
treated
for
highest
feed
item
TOTALZ=
85
TOTALFREQ=
1
15,0.009
Documentation:
doc
poultry
liver
lindane
DOC
ASSUMING
15%
crop
treated
for
highest
feed
item
TOTALZ=
85
TOTALFREQ=
1
15,0.006
17
Documentation:
doc
poultry
giblets
lindane
DOC
ASSUMING
15%
crop
treated
for
highest
feed
item
TOTALZ=
85
TOTALFREQ=
1
15,0.009
Documentation:
doc
poultry
fat
lindane
DOC
ASSUMING
15%
crop
treated
for
highest
feed
item
TOTALZ=
85
TOTALFREQ=
1
15,0.09
Documentation:
doc
poultry
meat
lindane
DOC
ASSUMING
15%
crop
treated
for
highest
feed
item
TOTALZ=
85
TOTALFREQ=
1
15,0.006
Documentation:
doc
swine
fat
lindane
DOC
ASSUMING
15%
crop
treated
for
highest
feed
item
TOTALZ=
85
TOTALFREQ=
1
15,0.021
Documentation:
doc
swine
meat
byproducts
lindane
DOC
ASSUMING
15%
crop
treated
for
highest
feed
item
TOTALZ=
85
TOTALFREQ=
1
15,0.002
Documentation:
doc
swine
liver
lindane
DOC
ASSUMING
15%
crop
treated
for
highest
feed
item
TOTALZ=
85
TOTALFREQ=
1
15,0.001
Documentation:
doc
swine
meat
lindane
DOC
ASSUMING
15%
crop
treated
for
highest
feed
item
TOTALZ=
85
TOTALFREQ=
1
15,0.002
Attachment
3:
Residue
Information
Acute
Analysis
using
feeding
study
18
F
i
l
e
n
a
m
e
: 
C
:\d
e
e
m
\
9
1\R
e
v
i
s
e
d
Analysis\
12­
11­
1\
12­
11­
1RevacuteTRR.
RS7
Chemical: 
Lindane
R
D(
Chronic): .
16 
mg/
kg 
bw/
day  
NOEL(
Chronic): .
47 
mg/
kg 
bw/
day
R
D(
Acute): .
2 
mg/
kg 
bw/
day  
NOEL(
Acute):  
6 
mg/
kg 
bw/
day 
Q*= 
1.
1
Date 
created/
last 
modi
ied: 
12­
3­
2
1/
5:
14:
17/
8          
Program
ver. 
7.
75
Comment: 
Re
erence 
doses 
have 
3X 
FQPA 
actored 
in. 
 
This 
is 
a
dietary 
analysis 
using 
the 
total 
radioactive 
residues 
rom 
the
plant 
and 
animal 
metabolism 
studies.

­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­

­­­­­­­­­­­­­­

RDL 
indices 
and 
parameters 
or 
Monte 
Carlo 
Analysis:

Index 
Dist 
Parameter #
1        
Param #
2  
Param #
3
  #   
Code 

­­­­­ ­­­­ ­­­­­­­­­­­­        ­­­­­­­­  ­­­­­­­

  
1    
6   
bee
meat.
rd
  
2    
6   
bee
at.
rd
  
3    
6   
bee
liver.
rd
  
4    
6   
bee
mbyp.
rd
  
5    
6   
poultryegg.
rd
  
6    
6   
poultry
at.
rd
  
7    
6   
poultrygiblets.
rd
  
8    
6   
poultryliver.
rd
  
9    
6   
poultrymbyp.
rd
  
1
   
6   
poultrymeat.
rd
  
11   
6   
swine
at.
rd
  
12   
6   
swineliver.
rd
  
13   
6   
swinembyp.
rd
  
14   
6   
swinemeat.
rd
  
15   
6   
milk.
rd
Food 
Crop 
Food 
Name                         
De
 Res     
Adj.
Factors
RDL
Code  
Grp                                    (
ppm)       #
1     #
2
 Pntr
­­­­ 
­­­­ 
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ 
 
­­­­­­­­­­ 
 
­­­­­

­­­­­­ ­­

 265 
15   
Barley                             
.
52
   
1.

.
3
 

 323 
M    
Bee
­dried                         
.
45
   
1.
92
.15
   
1
19
 324 
M    
Bee
­
at 
w/
o 
bones                 
.786
   
1.

.15
   
2
 325 
M    
Bee
­kidney                        
.1
9
   
1.

.15
   
4
 327 
M    
Bee
­lean (
at/
ree) 
w/
o 
bones     
.
45
   
1.

.15
   
1
 326 
M    
Bee
­liver                         
.511
   
1.

.15
   
3
 321 
M    
Bee
­meat 
byproducts               
.511
   
1.

.15
   
4
 322 
M    
Bee
­other 
organ 
meats             
.511
   
1.

.15
   
4
 3
1 
O    
Canola 
oil (
rape 
seed 
oil)         
.
25
   
1.

.1
 

 366 
P    
Chicken­
byproducts                 
.
4
   
1.

.15
   
9
 368 
P    
Chicken­
at 
w/
o 
bones              
.
4
   
1.

.15
   
6
 367 
P    
Chicken­
giblets(
liver)             
.
4
   
1.

.15
   
8
 385 
P    
Chicken­
giblets (
excl. 
liver)      
.
4
   
1.

.15
   
7
 369 
P    
Chicken­
lean/
at 
ree 
w/
o 
bones    
.
4
   
1.

.15
  
1
 267 
15   
Corn 
grain­
bran                    
.
1
   
1.

.15
 

 266 
15   
Corn 
grain­
endosperm               
.
1
   
1.

.15
 

 289 
15   
Corn 
grain­
oil                     
.
1
   
1.

.15
 

 268 
15   
Corn 
grain/
sugar/
h
cs              
.
1
   
1.
5
.15
 

 388 
15   
Corn 
grain/
sugar­
molasses          
.
1
   
1.
5
.15
 

 237 
15   
Corn/
pop                           
.
1
   
1.

.15
 

 238 
15   
Corn/
sweet                         
.
1
   
1.

.
1
 

 364 
P    
Eggs­
white 
only                    
.
8
   
1.

.15
   
5
 363 
P    
Eggs­
whole                         
.
1
   
1.

.15
   
5
20
 365 
P    
Eggs­
yolk 
only                     
.
4
   
1.

.15
   
5
 33
 M    
Goat­
at 
w/
o 
bone                  
.786
   
1.

.15
   
2
 331 
M    
Goat­
kidney                        
.1
9
   
1.

.15
   
4
 333 
M    
Goat­
lean (
at/
ree) 
w/
o 
bone      
.
45
   
1.

.15
   
1
 332 
M    
Goat­
liver                         
.511
   
1.

.15
   
3
 328 
M    
Goat­
meat 
byproducts               
.511
   
1.

.15
   
4
 329 
M    
Goat­
other 
organ 
meats             
.511
   
1.

.15
   
4
 334 
M    
Horsemeat                          
.
45
   
1.

.15
   
1
 398 
D    
Milk­
based 
water                   
.
68
   
1.

.15
  
15
 319 
D    
Milk­
at 
solids                    
.
68
   
1.

.15
  
15
 318 
D    
Milk­
non
at 
solids                 
.
68
   
1.

.15
  
15
 32
 D    
Milk 
sugar (
lactose)               
.
68
   
1.

.15
  
15
 399 
15   
Oats­
bran                          
.
52
   
1.

.
3
 

 269 
15   
Oats                               
.
52
   
1.

.
3
 

 344 
M    
Pork­
at 
w/
o 
bone                  
.
12
   
1.

.15
  
11
 345 
M    
Pork­
kidney                        
.
2
   
1.

.15
  
13
 347 
M    
Pork­
lean (
at 
ree) 
w/
o 
bone      
.
1
   
1.

.15
  
14
 346 
M    
Pork­
liver                         
.
8
   
1.

.15
  
12
 342 
M    
Pork­
meat 
byproducts               
.
8
   
1.

.15
  
13
 343 
M    
Pork­
other 
organ 
meats             
.
8
   
1.

.15
  
13
 362 
P    
Poultry­
other­
at 
w/
o 
bones        
.
4
   
1.

.15
   
6
21
 361 
P    
Poultry­
other­
giblets(
liver)       
.
4
   
1.

.15
   
8
 
36
 
P    
Poultry­
other­
lean 
(
at 
ree) 
w/ 
 
 
.
4
 
 
 
1.

.15
  
1
 274 
15   
Rye­
lour                          
.
52
   
1.

.
3
 

 273 
15   
Rye­
germ                           
.
52
   
1.

.
3
 

 272 
15   
Rye­
rough                          
.
52
   
1.

.
3
 

 338 
M    
Sheep­
at 
w/
o 
bone                 
.786
   
1.

.15
   
2
 339 
M    
Sheep­
kidney                       
.1
9
   
1.

.15
   
4
 341 
M    
Sheep­
lean (
at 
ree) 
w/
o 
bone     
.
45
   
1.

.15
   
1
 34
 M    
Sheep­
liver                        
.511
   
1.

.15
   
3
 336 
M    
Sheep­
meat 
byproducts              
.511
   
1.

.15
   
4
 337 
M    
Sheep­
other 
organ 
meats            
.511
   
1.

.15
   
4
 275 
15   
Sorghum (
including 
milo)           
.
1
   
1.

.
3
 

 355 
P    
Turkey­
byproducts                  
.
4
   
1.

.15
   
9
 357 
P    
Turkey­­
at 
w/
o 
bones              
.
4
   
1.

.15
   
6
 356 
P    
Turkey­
giblets (
liver)             
.
4
   
1.

.15
   
8
 358 
P    
Turkey­ 
lean/
at 
ree 
w/
o 
bones    
.
4
   
1.

.15
  
1
 449 
P    
Turkey­
other 
organ 
meats           
.
4
   
1.

.15
   
9
 429 
M    
Veal­
dried                         
.
45
   
1.
92
.15
   
1
 424 
M    
Veal­
at 
w/
o 
bones                 
.786
   
1.

.15
   
2
 426 
M    
Veal­
kidney                        
.1
9
   
1.

.15
   
4
 425 
M    
Veal­
lean (
at 
ree) 
w/
o 
bones     
.
45
   
1.

.15
   
1
22
 427 
M    
Veal­
liver                         
.511
   
1.

.15
   
3
 43
 M    
Veal­
meat 
byproducts               
.511
   
1.

.15
   
4
 428 
M    
Veal­
other 
organ 
meats             
.511
   
1.

.15
   
4
 278 
15   
Wheat­
bran                         
.
52
   
1.

.
3
 

 279 
15   
Wheat­
lour                        
.
52
   
1.

.
3
 

 277 
15   
Wheat­
germ                         
.
52
   
1.

.
3
 

 437 
15   
Wheat­
germ 
oil                     
.
52
   
1.

.
3
 

 276 
15   
Wheat­
rough                        
.
52
   
1.

.
3
 

Chronic
Analysis
using
feeding
study
F
i
l
e
n
am
e
: 
C
:\d
e
e
m
\
9
1
\R
e
v
i
s
e
d
Analysis\
12­
11­
1\
12­
11­
1RevchronicTRR.
RS7
Chemical: 
Lindane
R
D(
Chronic): .
16 
mg/
kg 
bw/
day  
NOEL(
Chronic): .
47 
mg/
kg 
bw/
day
R
D(
Acute): .
2 
mg/
kg 
bw/
day  
NOEL(
Acute):  
6 
mg/
kg 
bw/
day 
Q*= 
1.
1
Date 
created/
last 
modi
ied: 
12­
3­
2
1/
5:
15:
47/
8          
Program
ver. 
7.
75
Comment: 
Fe
erence 
doses 
have 
3X 
FQPA 
actored 
in.  
This 
is 
the
dietary 
analysis 
using 
the 
metabolism 
and 
eeding 
studies.

­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­

­­­­­­­­­­­­­­

Food 
Crop                                   
De
 Res     
Adj.
Factors
Code  
Grp  
Food 
Name                         (
ppm)       #
1    #
2
 

­­­­ 
­­­­ 
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­ 
 
­­­­­­­­­­ 
 
­­­­­

­­­­­

 265  
15  
Barley                             
.
52
   
1.

.
3
 323  
M   
Bee
­dried                         
.
5
   
1.
92
1.

 324  
M   
Bee
­
at 
w/
o 
bones                 
.
5
   
1.

1.

 325  
M   
Bee
­kidney                        
.
6
   
1.
23
1.

 327  
M   
Bee
­lean (
at/
ree) 
w/
o 
bones     
.
5
   
1.

1.

 326  
M   
Bee
­liver                         
.
2
   
1.

1.

 321  
M   
Bee
­meat 
byproducts               
.
6
   
1.

1.

 322  
M   
Bee
­other 
organ 
meats             
.
6
   
1.

1.

 3
1  
O   
Canola 
oil (
rape 
seed 
oil)         
.
25
   
1.

.1
 366  
P   
Chicken­
byproducts                 
.
3
   
1.

1.

 368  
P   
Chicken­
at 
w/
o 
bones              
.
4
   
1.

1.

 367  
P   
Chicken­
giblets(
liver)             
.
2
   
1.

1.

 385  
P   
Chicken­
giblets (
excl. 
liver)      
.
3
   
1.

1.

 369  
P   
Chicken­
lean/
at 
ree 
w/
o 
bones    
.
2
   
1.

1.

 267  
15  
Corn 
grain­
bran                    
.
1
   
1.

.15
 266  
15  
Corn 
grain­
endosperm               
.
1
   
1.

.15
 289  
15  
Corn 
grain­
oil                     
.
1
   
1.

.15
 268  
15  
Corn 
grain/
sugar/
h
cs              
.
1
   
1.
5
.15
 388  
15  
Corn 
grain/
sugar­
molasses          
.
1
   
1.
5
.15
 237  
15  
Corn/
pop                           
.
1
   
1.

.15
 238  
15  
Corn/
sweet                         
.
1
   
1.

.
1
 364  
P   
Eggs­
white 
only                    
.
2
   
1.

1.

 363  
P   
Eggs­
whole                         
.
2
   
1.

1.

 365  
P   
Eggs­
yolk 
only                     
.
2
   
1.

1.

 33
  
M   
Goat­
at 
w/
o 
bone                  
.
5
   
1.
24
1.

 331  
M   
Goat­
kidney                        
.
6
   
1.

1.

 333  
M   
Goat­
lean (
at/
ree) 
w/
o 
bone      
.
5
   
1.

1.

 332  
M   
Goat­
liver                         
.
2
   
1.

1.

 328  
M   
Goat­
meat 
byproducts               
.
6
   
1.

1.

 329  
M   
Goat­
other 
organ 
meats             
.
6
   
1.

1.

 334  
M   
Horsemeat                          
.
5
   
1.

1.

 398  
D   
Milk­
based 
water                   
.
5
   
1.

1.

 319  
D   
Milk­
at 
solids                    
.
5
   
1.

1.

 318  
D   
Milk­
non
at 
solids                 
.
5
   
1.

1.

 32
  
D   
Milk 
sugar (
lactose)               
.
5
   
1.

1.

 399  
15  
Oats­
bran                          
.
52
   
1.

.
3
 269  
15  
Oats                               
.
52
   
1.

.
3
 344  
M   
Pork­
at 
w/
o 
bone                  
.
7
   
1.

1.

 345  
M   
Pork­
kidney                        
.
8
   
1.

1.

 347  
M   
Pork­
lean (
at 
ree) 
w/
o 
bone      
.
8
   
1.

1.

 346  
M   
Pork­
liver                         
.
4
   
1.

1.

 342  
M   
Pork­
meat 
byproducts               
.
8
   
1.

1.

 343  
M   
Pork­
other 
organ 
meats             
.
8
   
1.

1.

 362  
P   
Poultry­
other­
at 
w/
o 
bones        
.
4
   
1.

1.

 361  
P   
Poultry­
other­
giblets(
liver)       
.
2
   
1.

1.

 
36
 
 
P 
 
 
Poultry­
other­
lean 
(
at 
ree) 
w/ 
 
 
.
2
 
 
 
1.
25
1.

 274  
15  
Rye­
lour                          
.
52
   
1.

.
3
 273  
15  
Rye­
germ                           
.
52
   
1.

.
3
 272  
15  
Rye­
rough                          
.
52
   
1.

.
3
 338  
M   
Sheep­
at 
w/
o 
bone                 
.
5
   
1.

1.

 339  
M   
Sheep­
kidney                       
.
6
   
1.

1.

 341  
M   
Sheep­
lean (
at 
ree) 
w/
o 
bone     
.
5
   
1.

1.

 34
  
M   
Sheep­
liver                        
.
2
   
1.

1.

 336  
M   
Sheep­
meat 
byproducts              
.
6
   
1.

1.

 337  
M   
Sheep­
other 
organ 
meats            
.
6
   
1.

1.

 275  
15  
Sorghum (
including 
milo)           
.
1
   
1.

.
3
 355  
P   
Turkey­
byproducts                  
.
3
   
1.

1.

 357  
P   
Turkey­­
at 
w/
o 
bones              
.
4
   
1.

1.

 356  
P   
Turkey­
giblets (
liver)             
.
2
   
1.

1.

 358  
P   
Turkey­ 
lean/
at 
ree 
w/
o 
bones    
.
2
   
1.

1.

 449  
P   
Turkey­
other 
organ 
meats           
.
3
   
1.

1.

 429  
M   
Veal­
dried                         
.
5
   
1.
92
1.

 424  
M   
Veal­
at 
w/
o 
bones                 
.
5
   
1.

1.

 426  
M   
Veal­
kidney                        
.
6
   
1.

1.

 425  
M   
Veal­
lean (
at 
ree) 
w/
o 
bones     
.
5
   
1.

1.

 427  
M   
Veal­
liver                         
.
2
   
1.

1.

 43
  
M   
Veal­
meat 
byproducts               
.
6
   
1.
26
1.

 428  
M   
Veal­
other 
organ 
meats             
.
6
   
1.

1.

 278  
15  
Wheat­
bran                         
.
52
   
1.

.
3
 279  
15  
Wheat­
lour                        
.
52
   
1.

.
3
 277  
15  
Wheat­
germ                         
.
52
   
1.

.
3
 437  
15  
Wheat­
germ 
oil                     
.
52
   
1.

.
3
 276  
15  
Wheat­
rough                        
.
52
   
1.

.
3
Attachment
4:
Acute
Analysis
Acute
Analysis
Using
Feeding
Studies
U.
S. 
Environmental 
Protection 
Agency                             

   
Ver. 
7.
74
DEEM 
ACUTE 
Analysis 
or 
LINDANE                                

(1989­
92 
data)

Residue 
ile: 
12­
11­
1RevacuteTRR.
RS7                 
Adjustment
actor #
2 
used.

Analysis 
Date: 
12­
11­
2
1/
16:
9:
    
Residue 
ile 
dated:

12­
3­
2
1/
5:
14:
17/
8
NOEL (
Acute) =   
6.
 mg/
kg 
body­
wt/
day
Daily 
totals 
or 
ood 
and 
ood
orm 
consumption 
used.

MC 
iterations = 
5
      
MC 
list 
in 
residue 
ile     
MC 
seed =

1
281
Run 
Comment: "
Re
erence 
doses 
have 
3X 
FQPA 
actored 
in.  
This 
is 
a
dietary 
ana
lysis 
using 
the 
total 
radioactive 
residues 
rom 
the 
plant 
and
animal 
metabolism
 studies."

=================================================================

==============

Summary 
calculations (
per 
capita):
27
      
95th 
Percentile             
99th 
Percentile           

99.
9th 
Percentile
 Exposure  % 
aR
D     
MOE    
Exposure  % 
aR
D     
MOE    
Exposure
% 
aR
D     
MOE  

­­­­­­­­­­ ­­­­­­­ ­­­­­­­­ ­­­­­­­­­­ ­­­­­­­ ­­­­­­­­ ­­­­­­­­­

­­­­­­­ ­­­­­­­

U.
S. 
Population:

  
.
16
    
.8
   
37614    
.
516    
2.
58   
11627    
.
13
5
  
6.
52    
4598  

U.
S. 
Population (
spring 
season):

  
.
16
    
.8
   
3739
    
.
5
3    
2.
51   
11934    
.
129
  
6.
45    
465
  

U.
S. 
Population (
summer 
season):

  
.
152    
.76   
39455    
.
521    
2.
6
   
11525    
.
1434
  
7.
17    
4185  

U.
S. 
Population (
autumn 
season):

  
.
166    
.83   
36
52    
.
563    
2.
82   
1
648    
.
1294
  
6.
47    
4636  

U.
S. 
Population (
winter 
season):

  
.
161    
.8
   
37353    
.
478    
2.
39   
12541    
.
1221
  
6.
1
    
4914  

Northeast 
region:

  
.
152    
.76   
39479    
.
521    
2.
61   
1151
    
.
1414
  
7.
7    
4243  

Midwest 
region:

  
.
181    
.91   
331
1    
.
574    
2.
87   
1
452    
.
1383
  
6.
92    
4337  

Southern 
region:

  
.
151    
.76   
39732    
.
457    
2.
29   
13125    
.
11
6
  
5.53    
5424  

Western 
region:

  
.
158    
.79   
37994    
.
523    
2.
62   
11466    
.
1376
  
6.
88    
436
  

Hispanics:

  
.
179    
.89   
336
4    
.
616    
3.
8    
9745    
.
1456
  
7.
28    
4122  

Non­
hispanic 
whites:

  
.
159    
.79   
37742    
.
5
9    
2.
54   
11795    
.
1281
  
6.
41    
4682  

Non­
hispanic 
blacks:

  
.
15
    
.75   
4
4
    
.
474    
2.
37   
12662    
.
13
7
  
6.
54    
459
  
28
Non­
hisp/
non­
white/
non­
black:

  
.
158    
.79   
38
1
    
.
591    
2.
96   
1
149    
.
1593
  
7.
97    
3765  

All 
in
ants:

  
.
2
4    
1.
2   
29448    
.
837    
4.
19    
7167    
.
332
 16.
6
    
18
7  

Nursing 
in
ants (<
1 
yr 
old):

  
.
64    
.32   
941
    
.
288    
1.
44   
2
823    
.
698
  
3.
49    
8599  

Non­
nursing 
in
ants (<
1 
yr 
old):

  
.
234    
1.
17   
25658    
.
1521    
7.
6
    
3945    
.
3626
 18.
13    
1654  

Children 
1­
6  
yrs:

  
.
668    
3.34    
8987    
.
1264    
6.
32    
4748    
.
1973
  
9.
86    
3
41  

Children 
7­
12 
yrs:

  
.
353    
1.
76   
17
17    
.
642    
3.
21    
9342    
.
1
88
  
5.
44    
5513  

Females 
13+ (
preg/
not 
nursing):

  
.
191    
.95   
31424    
.
342    
1.
71   
17528    
.
5
9
  
2.
54   
11797  

Females 
13+ (
nursing):

  
.
148    
.74   
4
598    
.
352    
1.
76   
17
23    
.
623
  
3.
11    
9632  

Females 
13­
19 (
not 
preg 
or 
nursing):

  
.
16
    
.8
   
374
5    
.
311    
1.
55   
19293    
.
676
  
3.38    
8874  

Females 
2
+ (
not 
preg 
or 
nursing):

  
.
99    
.5
   
6
5
3    
.
2
7    
1.
4   
28962    
.
4
5
  
2.
2   
14816  

Females 
13­
5
 yrs:

  
.
111    
.55   
54255    
.
245    
1.
23   
24444    
.
467
  
2.
34   
12844  

Males 
13­
19 
yrs:

  
.
2
1    
1.
   
29852    
.
413    
2.
6   
14542    
.
67
  
3.35    
896
  

Males 
2
+ 
yrs:

  
.
1
6    
.53   
56425    
.
225    
1.
13   
26647    
.
458
  
2.
29   
131
4  

Seniors 
55+:

  
.
99    
.5
   
6
477    
.
2
3    
1.
1   
29619    
.
4
9
  
2.
4   
14676  
29
Paci
ic:

  
.
156    
.78   
38498    
.
531    
2.
66   
11297    
.
1344
  
6.
72    
4462  

      
30
Attachment
5:
Chronic
Analysis
Chronic
Analysis
Using
Feeding
Study
U.
S. 
Environmental 
Protection 
Agency                             

  
Ver. 
7.
73
DEEM 
Chronic 
analysis 
or 
LINDANE                             

(1989­
92 
data)

Res
i
d
u
e
 
i
l
e
 
n
a
m
e
: 
C
:\d
e
e
m
\
9
1
\R
e
v
i
s
e
d
Analysis\
12­
11­
1\
12­
11­
1RevchronicTRR.
RS7
                                                     
Adjustment
actor #
2 
used.

Analysis 
Date 
12­
12­
2
1/
13:
26:
48     
Residue 
ile 
dated:

12­
3­
2
1/
5:
15:
47/
8
Re
erence 
dose (
R
D, 
Chronic) = .
16 
mg/
kg 
bw/
day
COMMENT 
1: 
Re
erence 
doses 
have 
3X 
FQPA 
actored 
in.  
This 
is 
the
dietary 
analysis 
using 
the 
metabolism 
and 
eeding 
studies.

=================================================================

==============

                    
Total 
exposure 
by 
population 
subgroup
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­

­­­­­­­­­­­­­

                                                    
Total 
Exposure
                                       

­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­

          
Population                         
mg/
kg           

Percent 
o
   

           
Subgroup                       
body 
wt/
day           

R
d       

­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­   ­­­­­­­­­­­­­     

­­­­­­­­­­­­­­

U.
S. 
Population (
total)                     
.
54             

  
3.
4%

U.
S. 
Population (
spring 
season)             
.
54             

  
3.3%

U.
S. 
Population (
summer 
season)             
.
53             
31
  
3.3%

U.
S. 
Population (
autumn 
season)             
.
56             

  
3.5%

U.
S. 
Population (
winter 
season)             
.
53             

  
3.3%

Northeast 
region                            
.
53             

  
3.3%

Midwest 
region                              
.
6
             

  
3.
7%

Southern 
region                             
.
51             

  
3.
2%

Western 
region                              
.
53             

  
3.3%

Hispanics                                   
.
59             

  
3.
7%

Non­
hispanic 
whites                         
.
54             

  
3.
4%

Non­
hispanic 
blacks                         
.
49             

  
3.
1%

Non­
hisp/
non­
white/
non­
black                
.
56             

  
3.5%

All 
in
ants (< 
1 
year)                      
.
72             

  
4.
5%

Nursing 
in
ants                             
.
19             

  
1.
2%

Non­
nursing 
in
ants                         
.
94             

  
5.
9%

Children 
1­
6  
yrs                           
.
173             

 1
.8%

Children 
7­
12 
yrs                           
.
96             

  
6.
%

Females 
13­
19 (
not 
preg 
or 
nursing)         
.
46             

  
2.
9%

Females 
2
+ (
not 
preg 
or 
nursing)           
.
29             

  
1.
8%

Females 
13­
5
 yrs                           
.
34             

  
2.
1%

Females 
13+ (
preg/
not 
nursing)              
.
49             
32
  
3.
%

Females 
13+ (
nursing)                       
.
43             

  
2.
7%

Males 
13­
19 
yrs                             
.
61             

  
3.8%

Males 
2
+ 
yrs                               
.
34             

  
2.
1%

Seniors 
55+                                 
.
3
             

  
1.
9%

Paci
ic 
Region                              
.
53             

  
3.3%

­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­

­­­­­­­­­­­­­­