Document ID: EPA-HQ-OPP-2002-0202-0022
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2002-08-14T04:00Z

July
17,
2002
MEMORANDUM:

SUBJECT:
Lindane
(009001):
Reregistration
Case
0315.
Addendum
to
the
Revised
Chemistry
and
HED
Chapters
(DP
Barcode:
D279259
&
D283643)
for
the
Lindane
Reregistration
Eligibility
Document
(RED).
DP
Barcode:
D284183.

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)

This
memorandum
serves
to
update
the
Tolerance
Tables
contained
in
the
Product
and
Residue
Chemistry
Chapter
(T.
Morton,
12/
11/
01,
D279259)
and
the
HED
Risk
Assessment
(B.
Daiss,
6/
13/
02,
D283643)
by
amending
the
tolerances
which
were
listed
as
TBD
(to
be
determined).
Recommended
tolerance
levels
for
lindane,
per
se,
in
cereal
grains
are
derived
from
the
wheat
magnitude
of
the
residue
study
(T.
Morton,
8/
30/
00,
D259318).
Tolerances
will
be
re­
evaluated
when
the
required
nature
of
the
residue
study
is
submitted.
2
EXECUTIVE
SUMMARY:

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

C
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.

cc
:
Chem
F,
Chron
F.
Morton
RDI:
SVH:
7/
17/
02
TM,
Thurston
Morton,
Rm.
816D
CM2,
305­
6691,
mail
code
7509C
3
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
1,2,3,4,5,6­
hexachlorocyclohexane.
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
and
proposed
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).

At
this
time,
lindane
tolerances
are
being
reassessed
in
terms
of
lindane,
per
se.
The
nature
of
the
residue
in
plants
and
animals
must
be
adequately
elucidated,
and
HED's
MARC
must
determine
the
terminal
residues
of
concern.
The
tolerances
will
be
reevaluated
once
an
adequate
nature
of
the
residue
study
in
plants
is
submitted.

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
(c)
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.

Tolerances
To
Be
Proposed
Under
40
CFR
§180.133:

Tolerances
for
lindane,
per
se,
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;
4
sorghum,
stover;
wheat,
grain;
wheat,
forage;
wheat,
hay;
and
wheat,
straw.
In
addition,
tolerances
for
lindane,
per
se,
need
to
be
established
for
meat
byproducts
of
cattle,
goat,
horse,
and
sheep;
fat
of
cattle,
goat,
hog,
horse,
and
sheep;
milk;
and
fat
of
poultry.
The
remaining
livestock
tissues
(meat
and
meat
byproducts
of
hog
and
poultry;
and
eggs
are
40
CFR
180.6(
a)(
3)
[no
reasonable
expectation
of
finding
finite
lindane
residues]
provided
the
HED
MARC
determines
lindane,
per
se,
is
the
only
residue
of
concern.
The
tolerances
for
lindane,
per
se,
will
be
re­
evaluated
once
adequate
nature
of
the
residue
data
in
plants
are
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
acceptable
nature
of
the
residue
study
in
plants
was
submitted.
At
this
time,
tolerance
levels
for
lindane,
per
se,
are
being
recommended
for
cereal
grains.
These
tolerances
will
be
re­
evaluated
once
adequate
nature
of
the
residue
data
are
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
until
adequate
nature
of
the
residue
data
in
plants
are
submitted.
5
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
0.
05
The
Agency
will
re­
calculate
the
maximum
theoretical
dietary
burden
for
livestock
animals
and
re­
evaluate
the
adequacy
of
the
available
animal
feeding
studies
when
the
required
nature
of
the
residue
data
in
plants
have
been
received
and
evaluated.
/
Cattle,
fat;
goat,
fat;
horse,
fat;
sheep,
fat
Hog,
fat
Fat
of
meat
from
hogs
4
0.
01
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.
Commodity
Tolerance
Listed
Under
40
CFR
(ppm)
Reassessed
Tolerance
(ppm)
Comment
[Correct
Commodity
Definition]

6
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.

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
0.005
A
nature
of
the
residue
study
for
lindane
residues
resulting
from
seed
treatment
application
to
a
cereal
grain
is
required.
The
Agency
will
recalculate
the
maximum
theoretical
dietary
burden
for
livestock
animals
and
re­
evaluate
the
adequacy
of
the
available
animal
feeding
studies
when
the
required
nature
of
the
residue
data
in
plants
have
been
received
and
evaluated.
Barley,
hay
0.
02
Barley,
straw
0.
005
Corn,
field,
grain
0.
005
Corn,
pop,
grain
0.
005
Corn,
sweet,
kernel
plus
cob
with
husks
removed
0.005
Corn,
,
field,
forage
0.05
Corn,
sweet,
forage
0.05
Corn,
field,
stover
0.
05
Corn,
pop,
stover
0.
05
Corn,
sweet,
stover
0.
05
Oat,
grain
0.
005
Oat,
forage
0.05
Oat,
hay
0.
02
Oat,
straw
0.
005
Rye,
grain
0.
005
Rye,
forage
0.05
Rye,
straw
0.
005
Sorghum,
grain,
grain
0.
005
Sorghum,
forage
0.05
Sorghum,
grain,
stover
0.
05
Wheat,
grain
0.
005
Wheat,
forage
0.05
Wheat,
hay
0.
02
Wheat,
straw
0.
005
Cattle,
meat
byproducts
0.01
Commodity
Tolerance
Listed
Under
40
CFR
(ppm)
Reassessed
Tolerance
(ppm)
Comment
[Correct
Commodity
Definition]

7
Goat,
meat
byproducts
0.01
Horse,
meat
byproducts
0.01
Sheep,
meat
byproducts
0.01
Cattle,
meat
0.01
Goat,
meat
0.01
Horse,
meat
0.01
Sheep,
meat
0.01
Milk
0.01
Poultry,
fat
0.
01
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
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.

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).
8
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
0.005
ppm
for
the
grains
of
barley,
oats,
rye,
and
wheat
The
Agency
will
re­
evaluate
the
cereal
grain
tolerances
when
the
required
nature
of
the
residue
data
in
plants
have
been
received
and
evaluated.

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
The
Agency
will
re­
calculate
the
maximum
theoretical
dietary
burden
for
livestock
animals
and
re­
evaluate
the
adequacy
of
the
available
animal
feeding
studies
when
the
required
nature
of
the
residue
data
in
plants
have
been
received
and
evaluated.

Endive
2
(CXL)
None
established
Not
being
supported
for
reregistration.
Codex
Reassessed
U.
S.
Tolerance,
ppm
1
Codex
Comments
Commodity,
As
Defined
MRL
in
mg/
kg
(Step)

9
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)
0.01
(cattle
and
sheep)
See
"Eggs"

Milks
0.
1
(CXL)
0.
01
See
"Eggs"

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
See
"Eggs"

Radish
1
(CXL)
Revoke
Not
being
supported
for
reregistration.

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

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

Strawberry
3
(CXL)
Revoke
Not
being
supported
for
reregistration.

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.