Document ID: EPA-HQ-OPP-2002-0202-0068
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2005-03-16T05:00Z

Telephone
#
703­
308­
8000
Fax
#
703­
308­
8005
E­
mail:
Edwards.
Debbie@
epa.
gov
UNITED
STATES
ENVIRONMENTAL
PROTECTION
AGENCY
WASHINGTON,
D.
C.
20460
OFFICE
OF
PREVENTION,
PESTICIDES
AND
TOXIC
SUBSTANCES
OFFICE
OF
PESTICIDE
PROGRAMS
SPECIAL
REVIEW
and
REREGISTRATION
DIVISION
(
7508C)

Debra
Edwards,
Ph.
D.,
Director
March
16,
2005
Aaron
Colangelo
Natural
Resources
Defense
Council
1200
New
York
Avenue,
NW,
Suite
400
Washington,
DC
20005
Dear
Mr.
Colangelo,

I
am
writing
to
respond
to
the
two
letters
you
sent
to
me
dated
January
26,
2005
regarding
lindane.
Your
letters
focus
on
OPP's
response
to
a
June
7,
2004
letter
from
the
Natural
Resources
Defense
Council
(
NRDC)
which
posed
numerous
questions
regarding
the
lindane
Reregistration
Eligibility
Decision
(
RED).
As
you
note
in
your
January
26
letters,
OPP
met
with
NRDC
on
July
2,
2004
to
discuss
the
June
7,
2004
letter,
and
the
Agency
also
sent
a
letter
dated
July
13,
2004
in
response.

I
want
to
clarify
what
appear
to
be
several
misunderstandings
arising
from
the
July
2,
2004
meeting
and
OPP's
July
13,
2004
letter.
In
your
letter,
you
state
that
I
refused
to
respond
to
NRDC's
list
of
questions
because,
"
the
issuance
of
the
lindane
RED
closed
the
door
to
further
discourse
about
the
risks
of
lindane."
That
is
simply
not
the
case.
During
our
meeting,
I
specifically
stated
that
the
lindane
RED
left
open
several
issues
surrounding
the
seed
treatment
uses
and
that
an
assessment
of
risks
associated
with
those
uses
would
be
completed
by
the
Agency.
I
also
stated
that
Agency
scientists
would
consider
the
information
and
questions
in
NRDC's
letter
as
they
developed
a
risk
assessment
of
the
seed
treatment
uses,
in
addition
to
the
comments
submitted
earlier
by
NRDC
during
the
public
comment
period
following
issuance
of
the
RED.
I
stated
my
belief
that
a
more
appropriate
time
for
Agency
scientists
and
NRDC
scientists
to
meet
would
be
during
that
review
process.
Contrary
to
the
statement
in
your
most
recent
letter,
I
have
not
foreclosed
discussion
on
NRDC's
issues
because
the
RED
has
issued.
OPP
intends
to
complete
its
assessment
of
the
remaining
seed
treatment
uses
on
or
prior
to
August
3,
2006
and
so
you
may
expect
risk
assessment
activity
to
begin
within
the
coming
year.
As
is
our
usual
practice,
there
will
be
additional
opportunity
for
public
input
as
we
work
toward
a
regulatory
decision
on
these
uses.
Telephone
#
703­
308­
8000
Fax
#
703­
308­
8005
E­
mail:
Edwards.
Debbie@
epa.
gov
­
2
­

You
also
stated
that
I
refused
to
allow
further
meetings
between
OPP
and
NRDC
scientists
and
that
I
am
ignoring
NRDC's
questions
regarding
the
lindane
RED.
Again,
I
do
not
believe
this
is
an
accurate
description
of
our
July
2,
2004
meeting.
As
noted
above,
I
do
believe
it
will
be
appropriate
for
OPP
and
NRDC
scientists
to
meet
to
discuss
technical
issues
when
the
Agency
has
started
the
process
of
assessing
the
risks
of
the
seed
treatment
uses.
You
should
not
confuse
or
misconstrue
my
concerns
about
the
timing
of
such
a
meeting
as
an
outright
refusal
to
meet
with
NRDC.
Your
letter
clearly
reflects
a
misunderstanding
of
my
comments
during
the
July
2,
2004
meeting,
and
I
hope
this
letter
helps
to
clarify
my
intent.

Your
letter
also
states
that
OPP
has
acted
contrary
to
past
practice
and
legal
requirements
by
not
granting
NRDC
the
same
access
as
the
regulated
community.
I
strongly
disagree
with
your
characterizations
in
this
regard.
OPP
is
always
willing
to
meet
with
any
group,
whether
a
public
interest
group
or
regulated
entity,
that
wishes
to
present
data
or
information
to
OPP
or
to
advocate
a
specific
course
of
action.
I
believe
our
practice
has
been
consistent
with
this
policy.
Your
letter,
however,
seeks
a
different
type
of
meeting.
You
are
seeking
access
to
OPP
scientists
for
the
purpose
of
asking
well
over
100
detailed
questions
about
a
RED.
Rather
than
seeking
to
present
information
to
the
Agency,
you
are
essentially
asking
the
Agency
to
present
information
to
you.
Your
June
7,
2004
letter
thus
requests
a
different
type
of
meeting
than
that
to
which
OPP
typically
agrees.
Therefore,
I
do
not
believe
you
are
correct
in
asserting
that
OPP
is
providing
preferential
treatment
to
the
regulated
community
by
refusing
to
make
our
scientists
available
to
answer
your
questions.

Your
recent
letter
also
requested
an
update
on
the
actions
OPP
outlined
in
its
July
13,
2004
letter,
and
I
am
happy
to
do
that.
SRRD/
OPP
has
prepared
a
Federal
Register
notice
to
revoke
certain
lindane
tolerances.
I
expect
this
revocation
notice
to
publish
in
the
very
near
future.
The
2002
RED
set
forth
specific
risk
mitigation
measures
for
lindane
end­
use
product
labels.
The
revised
labels
have
been
received
from
the
registrants
and
have
been
reviewed
and
approved
by
OPP.
In
addition,
since
July
2004,
OPP
has
processed
several
cancellations
for
products
containing
lindane.
In
October
2004,
nine
products
were
cancelled
due
to
non­
payment
of
maintenance
fees
(
69
FR,
No.
207:
62666­
62678).
In
March
2005,
a
notice
of
receipt
of
request
to
voluntarily
cancel
eight
lindane
registrations
was
published
(
70
FR,
No.
45:
11634­
11646).
One
of
the
products
for
which
voluntary
cancellation
has
been
requested
(
42056­
11;
Kernel
Guard)
has
accounted
for
approximately
two
thirds
of
all
lindane
sales
in
the
U.
S.
Telephone
#
703­
308­
8000
Fax
#
703­
308­
8005
E­
mail:
Edwards.
Debbie@
epa.
gov
­
3
­

Finally,
in
our
July
2,
2004
meeting
you
indicated
that
NRDC
was
aware
of,
and
would
provide,
information
regarding
the
exposure
of
U.
S.
indigenous
populations
to
lindane
or
its
isomers
as
a
result
of
long
range,
i.
e.,
transcontinental
oceanic
and
atmospheric,
transport.
To
my
knowledge,
NRDC
has
yet
to
submit
this
information
to
the
OPP
docket
or
directly
to
me
or
my
staff.
We
are
very
interested
in
discussing
any
information
you
may
have
or
of
which
you
may
have
knowledge
regarding
the
relationship
of
the
traditional
subsistence
diet
of
indigenous
people
and
concentrations
of
the
isomers
of
hexachlorocyclohexane
in
human
milk
and
body
fat.
We
plan
to
carefully
consider
this
exposure
pathway
in
our
lindane
risk
assessment.
Thus,
I
hope
you
are
able
to
provide
what
you
have
in
the
near
future
and
would
envision
that
a
meeting
in
which
you
present
your
analysis
of
such
information
to
Agency
scientists
and
risk
managers
could
be
very
helpful
to
our
understanding
of
this
exposure
pathway.

Sincerely,

Debra
Edwards,
Ph.
D.
Director
Special
Review
and
Reregistration
Division