1
UNITED
STATES
ENVIRONMENTAL
PROTECTION
AGENCY
WASHINGTON,
D.
C.
20460
OFFICE
OF
PREVENTION,
PESTICIDES
AND
TOXIC
SUBSTANCES
July
13,
2004
Mr.
Aaron
Colangelo,
Esq.
Natural
Resources
Defense
Council
1200
New
York
Avenue,
NW
Suite
400
Washington,
DC
20005
Subject:
Lindane
­
Response
to
June
7,
2004,
NRDC
Letter
Dear
Mr.
Colangelo:

Thank
you
for
your
June
7,
2004,
letter
concerning
the
lindane
risk
assessment
and
Reregistration
Eligibility
Decision
(
RED)
document
and
for
meeting
with
the
Agency
on
July
2,
2004.
As
stated
in
the
meeting,
we
are
sending
this
letter
to
summarize
the
Agency's
intended
actions
with
regards
to
the
pesticide
lindane:

$
the
Agency
intends
to
revoke
current
tolerances
for
lindane,
as
proposed
in
the
July
31,
2002,
RED
document
for
lindane,
and
will
be
initiating
this
process
shortly;

$
the
Agency
intends
to
expedite
the
review
of
revised
lindane
end­
use
product
labels
that
are
being
submitted
in
October
to
reflect
the
mitigation
specified
in
the
2002
RED;

$
the
Agency
intends
to
consider
establishing
tolerances
for
the
seed
treatment
uses
of
lindane;
and
$
at
the
appropriate
time,
the
Agency
will
prepare
a
response
to
comments
document
that
addresses
comments
received
during
the
public
comment
period
for
the
RED.

In
order
for
the
Agency
to
establish
all
required
tolerances
for
residues
of
lindane
on
food,
2
the
Agency
must
receive
and
review
additional
data
to
characterize
lindane
metabolites
and
must
be
able
to
determine
that
the
new
tolerances
meet
the
safety
standard
in
the
Federal
Food,
Drug,
and
Cosmetic
Act
(
FFDCA).
The
registrant
is
conducting
studies
on
the
nature
of
lindane
residues
on
commodities
grown
from
treated
seed,
and
the
Agency
expects
to
receive
the
data
by
the
end
of
this
calendar
year.
After
we
receive
the
residue
data,
Agency
scientists
will
review
these
data
to
determine
if
residues
of
significance
other
than
lindane
per
se
are
present.
Depending
on
the
outcome
of
this
review,
further
data
may
be
required
as
described
in
the
2002
lindane
RED.
Concurrent
with
these
science
reviews,
the
Agency
will
consider
whether
it
must
aggregate
exposure
from
the
pharmaceutical
use
of
lindane
in
order
to
make
the
safety
finding.
The
Agency
will
then
review
the
existing
risk
assessments
and
relevant
new
information
in
order
to
make
a
decision
as
to
whether
or
not
new
tolerances
can
be
established
that
meet
the
safety
standard
in
FFDCA.
At
that
time,
the
Agency
may
find
it
appropriate
to
revise
portions
of
the
existing
risk
assessments.
If
the
Agency
decides
to
establish
the
new
tolerances,
the
Agency
will
publish
that
decision
in
the
Federal
Register.

As
stated
in
the
2002
lindane
RED,
the
currently
registered
lindane
seed
treatment
products
would
be
eligible
for
reregistration
provided
that
the
following
conditions
are
met:
registrants
make
the
changes
to
the
terms
and
conditions
of
product
registrations
as
specified
in
the
RED;
registrants
provide
the
required
data;
and
EPA
is
able
to
establish
all
required
tolerances
for
residues
of
lindane
on
food.

Please
note
that
the
Agency
plans
to
place
the
June
7,
2004,
letter,
this
letter,
and
a
meeting
summary
in
the
lindane
public
docket.
Please
contact
Kimberly
Nesci
at
(
703)
308­
8059
or
by
email
at
nesci.
kimberly@
epa.
gov
if
you
have
any
questions
regarding
this
letter.

Sincerely,

Debra
Edwards,
Ph.
D.
Director
Special
Review
and
Reregistration
Division
Office
of
Pesticide
Programs
