Document ID: EPA-HQ-OPP-2002-0202-0059
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2003-02-04T05:00Z

UNITED
STATES
ENVIRONMENTAL
PROTECTION
AGENCY
WASHINGTON,
D.
C.
20460
OFFICE
OF
PREVENTION,
PESTICIDES
AND
TOXIC
SUBSTANCES
CERTIFIED
MAIL
7001
1140
0001
4913
XXXX
Name
Company
Street
Address
City,
State;
zip
code
Re:
Lindane
Tolerances
Dear
Mr.
XXXXXX:

The
Environmental
Protection
Agency
(
EPA
or
the
Agency)
recently
completed
a
Reregistration
Eligibility
Decision
(
RED)
for
lindane
and
has
determined
that:
1)
the
use
of
lindane
for
seed
treatment
is
likely
to
result
in
residues
in
raw
agricultural
commodities
derived
from
plants
grown
from
seeds
treated
with
lindane;
2)
new
tolerances
must
be
established
for
residues
of
lindane
in
food/
feed
commodities
before
the
currently
registered
lindane
products
may
be
reregistered;
and
3)
currently
registered
seed
treatment
uses
would
be
eligible
for
reregistration
provided
that
registrants
submit
the
required
data,
make
changes
to
the
registration
terms
and
conditions
as
specified
in
the
lindane
RED,
and
EPA
is
able
to
establish
all
required
tolerances
for
residues
of
lindane
in
food
that
meet
the
safety
standard
in
Federal
Food,
Drug,
and
Cosmetic
Act
(
FFDCA).

The
lindane
RED
was
based
in
part
on
human
health
and
ecological
risk
assessments,
which
were
conducted
using
maximum
application
rates
for
lindane
seed
treatment
specified
on
currently
approved
labels
and
data
intended
to
support
these
uses.
The
wheat
field
trial
data,
submitted
in
conjunction
with
a
petition
(
PP#
9F05057)
to
establish
tolerances
for
seed
treatment
uses
on
wheat,
barley,
oats,
and
rye
reflect
an
application
rate
of
0.033
lb
ai/
100
lb
seed,
which
is
lower
than
the
maximum
application
rate
currently
permitted
on
some
lindane
product
labels
used
in
the
RED.
According
to
EPA's
regulatory
files,
the
maximum
label
rate
for
wheat
is
0.0426
lb
ai/
100
lb
seed
and
for
barley
is
0.0375
lb
ai/
100
lb
seed;
the
maximum
rate
for
oats
is
0.03125
lb
ai/
100
lb
seed
and
for
rye
is
0.0328
lb
ai/
100
lb
seed.
Consequently,
the
currently
available
wheat
field
trial
study
can
be
used
to
support
the
establishment
of
new
tolerances
for
lindane
in
oats
and
rye
at
the
current
maximum
application
rates
that
are
on
the
labels.
For
the
tolerances
to
be
established
for
lindane
use
on
wheat
and
barley,
which
would
be
based
on
the
wheat
field
trial
study,
the
maximum
application
rates
for
wheat
and
barley
seed
treatment
currently
permitted
on
lindane
labels
would
need
to
be
lowered
to
0.033
lb
ai/
100
lb
seed
or
less.
2
Alternatively,
additional
residue
field
trials
could
be
conducted
for
seed
treatment
at
the
higher
label
rates
and
to
support
tolerances
associated
with
the
higher
rates
that
were
used
for
the
lindane
RED.

Tolerances
for
corn
and
sorghum
are
supported
from
a
separate
field
trial
study
conducted
at
the
appropriate
rate.
Therefore,
no
additional
field
trials
or
label
modifications
are
necessary
to
support
corn
or
sorghum
tolerances
at
this
time.

Please
inform
the
Agency
of
your
intended
course
of
action
in
writing
by
specifying
one
of
the
following
options
within
30
days
of
receipt
of
this
letter:
1)
revise
the
maximum
application
rate
of
labels
registered
to
your
company
to
be
no
greater
than
0.033
lb
ai/
100
lb
of
seed
for
lindane
treatment
of
wheat
and
barley
seeds,
and
submit
the
revised
labels
within
the
same
(
eight
months
from
the
receipt
of
the
product
specific
data
call­
in
to
be
issued
later)
time
frame
for
other
label
amendments
cited
in
the
RED;
or
2)
conduct
residue
field
trials
necessary
to
support
tolerances
on
wheat
and
barley
that
would
result
from
the
higher
maximum
application
rates
used
to
determine
the
eligibility
of
the
wheat
and
barley
tolerances
in
the
lindane
RED;
or
3)
indicate
that
the
maximum
labeled
application
rates
for
lindane
treatment
of
wheat
and
barley
seeds
for
your
product
registrations
do
not
exceed
0.033
lb
ai/
100
lb
of
seed.

If
you
have
any
questions
or
comments,
please
contact
me
directly
by
phone
at
(
703)
308­
8172
or
by
e­
mail
at
howard.
markt@
epa.
gov.
If
for
some
reason
I
am
unavailable,
please
contact
Mike
Goodis,
the
Acting
Chief
of
Reregistration
Branch
3,
by
phone
at
(
703)
308­
8157
or
by
e­
mail
at
goodis.
michael@
epa.
gov.

Sincerely,

Mark
Howard
Chemical
Review
Manager,
Reregistration
Branch
3,
Special
Review
and
Reregistration
Division
copy:
All
lindane
registrants