Document ID: EPA-HQ-OPP-2002-0202-0073
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2006-08-02T04:00Z

1
UNITED
STATES
ENVIRONMENTAL
PROTECTION
AGENCY
WASHINGTON,
D.
C.
20460
OFFICE
OF
PREVENTION,
PESTICIDES
AND
TOXIC
SUBSTANCES
July
24,
2006
MEMORANDUM
SUBJECT:
Agency
Response
to
Comments
on
the
2002
Lindane
RED
FROM:
Mark
T.
Howard
Chemical
Review
Manager
Reregistration
Branch
3
TO:
Public
Docket
for
Lindane
(
FDMS
Docket
#
OPP­
2002­
0202)

The
Agency
received
a
broad
range
of
comments
in
response
to
EPA's
Notice
of
Availability
for
Public
Comment
on
the
Lindane
Reregistration
Eligibility
Decision
(
67
FR
59500,
September
23,
2002).
The
Federal
Register
Notice
60­
day
public
comment
period
ran
from
September
23
to
November
22,
2002.
A
total
of
229
comments
were
received
from
registrants,
private
citizens,
state
and
local
government
agencies,
non­
profit
environmental
and
consumer
groups,
industry
interest
groups,
and
commodity­
based
associations.
The
vast
majority
of
comments
came
from
private
citizens
through
an
e­
mail
campaign
asking
to
discontinue
the
use
of
lindane,
particularly
pharmaceutical
uses
of
lindane.
The
attachments
to
this
memo
address
new
issues
raised
by
the
public.
Several
comments
received
were
redundant
from
previous
comment
periods
and
responses
can
be
found
in
earlier
response
to
comment
documents.

There
are
four
attachments
to
this
document,
as
follows:
Attachment
A,
a
memorandum
from
the
Health
Effects
Division
(
HED),
addresses
comments
on
the
human
health
risk
assessment;
Attachment
B,
a
memorandum
from
the
Environmental
Fate
and
Effects
Division
(
EFED),
addresses
comments
on
the
environmental
risk
assessment;
Attachment
C,
a
memorandum
from
the
Office
of
General
Counsel,
addresses
a
data
compensation
issue;
and
Attachment
D,
a
document
that
lists
all
the
names
of
stakeholder
groups
who
submitted
comments.

While
the
attachments
to
this
document
respond
to
technical
questions
and
comments
on
the
Lindane
RED,
this
memorandum
also
describes
EPA
policy
on
whether
the
Federal
Food,
Drug,
and
Cosmetic
Act
(
FFDCA)
requires
the
Agency
to
include
in
its
safety
assessment
those
exposures
resulting
from
the
use
of
lindane
in
pharmaceutical
products
in
response
to
the
public
comments
on
this
issue.

Public
Comments.
Crompton
Corporation
argued
that
pharmaceutical
uses
should
not
be
considered
in
the
risk
assessment.
The
Consumer
Specialty
Products
Association
argued
that
that
EPA
does
not
have
the
authority
under
FFDCA
&
FQPA
to
regulate
any
non­
pesticide,
food
use
2
(
such
as
pharmaceutical
uses).
The
Consumers
Union
argued
that
FQPA
requires
that
EPA
consider
pharmaceutical
uses.
Beyond
Pesticides
argued
that
all
pharmaceutical
uses
should
be
included
in
the
aggregate
risk
assessment.
The
American
Chemistry
Council
argued
that
FQPA
does
not
intend
for
EPA
to
incorporate
any
pharmaceutical
use
or
non­
pesticidal
uses
in
its
aggregate
assessments.
The
Natural
Resources
Defense
Council
argued
that
EPA
needs
to
aggregate
pharmaceutical
use
in
its
risk
assessments.

After
carefully
considering
the
comments
from
the
public,
FDA,
public
interest
groups,
industry
groups,
and
other
interested
parties,
EPA
has
concluded
the
following:

In
determining
the
risk
to
human
health,
the
Agency
examines
more
than
just
dietary
exposures.
Section
408
of
FFDCA
requires
EPA
to
consider
potential
sources
of
exposure
to
a
pesticide
and
related
substances
in
addition
to
the
dietary
sources
expected
to
result
from
a
pesticide
use
subject
to
the
tolerance.
In
order
to
determine
whether
to
maintain
a
pesticide
tolerance,
EPA
must
"
determine
that
there
is
a
reasonable
certainty
of
no
harm.
.
.
."
Under
FFDCA
section
505,
the
Federal
Drug
Administration
reviews
human
drugs
for
safety
and
effectiveness
and
may
approve
a
drug
notwithstanding
the
possibility
that
some
patients
may
experience
adverse
side
effects.
EPA
does
not
believe
that,
for
purposes
of
the
section
408
dietary
risk
assessment,
it
is
compelled
to
treat
a
pharmaceutical
patient
the
same
as
a
non­
patient,
or
to
assume
that
combined
exposures
to
pesticide
and
pharmaceutical
residues
that
lead
to
a
physiological
effect
in
the
patient
constitutes
"
harm"
under
the
meaning
of
section
408
of
the
FFDCA.

EPA
believes
the
appropriate
way
to
consider
the
pharmaceutical
use
of
lindane
in
its
risk
assessment
would
be
to
examine
the
impact
that
the
additional
non­
occupational
pesticide
exposures
would
have
to
a
pharmaceutical
patient
exposed
to
the
same
compound.
Where
the
additional
pesticide
exposure
has
no
more
than
a
minimal
impact
on
the
pharmaceutical
patient,
EPA
could
make
a
reasonable
certainty
of
no
harm
finding
for
the
pesticide
tolerances
of
that
compound
under
section
408
of
the
FFDCA.
If
the
potential
impact
on
the
pharmaceutical
user
as
a
result
of
co­
exposure
from
pesticide
use
is
more
than
minimal,
then
EPA
would
not
be
able
to
conclude
that
pesticide
residues
were
safe.

However,
in
the
case
of
lindane,
the
Agency
will
be
publishing
an
Addendum
to
the
RED
that
addresses
the
continued
registration
of
lindane.
Thus,
the
co­
exposure
approach
discussed
above
is
not
being
presented
in
this
document.

Further
information
on
FDA
and
how
it
regulates
lindane
can
be
obtained
from
its
website:
www.
fda.
gov;
e.
g.,
http://
www.
fda.
gov/
bbs/
topics/
ANSWERS/
ANS00725.
html.

Atttachments
Attachment
A
A
­
1
UNITED
STATES
ENVIRONMENTAL
PROTECTION
AGENCY
WASHINGTON,
D.
C.
20460
Office
of
Prevention,
Pesticides
and
Toxic
Substances
February
28,
2003
MEMORANDUM
SUBJECT:
Lindane;
Chemical
No.
009001.
HED's
Response
to
Public
Comment
on
HED's
Revised
Risk
Assessment
for
Lindane
Registration
Eligibility
Document
(
RED)

DP
Barcode:
D287964
Reregistration
Case
#:
0315
FROM:
Becky
Daiss
Environmental
Health
Scientist
Reregistration
Branch
4/
HED
(
7509C)

THROUGH:
Susan
Hummel
Branch
Senior
Scientist
Reregistration
Branch
4/
HED
(
7509C)

TO:
Mark
Howard
Reregistration
Branch
3
Special
Review
&
Reregistration
Division
(
7508C)

This
provides
the
Health
Effects
Division's
(
HED)
response
to
comments
from
the
public
on
EPA's
July
31,
2002
Revised
Human
Health
Risk
Assessment
for
Lindane
(
gammahexachlorocyclohexane
The
following
organizations
submitted
comments
on
the
human
health
risk
assessment;
National
Resources
Defence
Council
(
NRDC),
National
Pediculosis
Association,
Inc.
(
NPA),
Pesticide
Action
Network
North
America
(
PANNA),
Alaska
Community
Action
on
Toxics
(
ACAT),
Beyond
Pesticides,
Office
of
the
Attorney
General
of
the
State
of
New
York,
Crompton
Corporation,
American
Chemistry
Council
(
ACC),
and
Consumer
Specialties
Products
Association,
Inc
(
CSPA).
This
memorandum
addresses
only
those
comments
that
have
not
been
raised
and
responded
to
in
previous
public
comment
and
response
documents.
(
B.
Daiss,
D282320,
4/
25/
02,
D280623,
1/
30/
2002)
Attachment
A
A
­
2
Comments
on
the
Assessment
of
Risks
from
Use
of
Lindane
for
Treatment
of
Lice
and
Scabies
Public
Comment:
In
comments
on
the
blood
level
analysis
used
to
assess
potential
risks
from
lindane
used
as
a
scabies
treatment,
Crompton
Corporation
disagrees
with
HED's
use
of
a
10
fold
uncertainty
factor
to
account
for
variability
of
responses
in
humans.
Crompton
states
that
an
uncertainty
factor
of
10
is
not
necessary
because
the
comparison
of
blood
levels
rather
than
administered
dose
takes
into
account
the
phamacokinetics
portion
of
the
10­
fold
intraspecies
uncertainty
factor
and
that,
therefore,
a
3
fold
factor
is
sufficient.

HED
Response:
HED
believes
that
use
of
an
uncertainty
factor
of
10
to
address
intraspecies
variation
in
exposure
related
effects
is
reasonable
regardless
of
the
route
of
administration
and
irrespective
of
whether
potential
differences
in
phamacokinectic
uptake
and
distribution
are
accounted
for.

Public
Comment:
NRDC,
Office
of
Attorney
General
of
the
State
of
New
York,
PANNA,
ACAT,
and
NPA
commented
on
HED's
failure
to
perform
a
Margin
of
Exposure
(
MOE)
analysis
for
use
of
lindane
to
treat
head
lice.
Several
of
these
organizations
submitted
MOE
analyses
for
EPA's
consideration.

HED
Response:
As
should
have
been
pointed
out
in
HED's
Revised
Assessment
of
Risk
from
Use
of
Lindane
for
Treatment
of
Lice
and
Scabies,
HED
did
not
conduct
an
MOE
analysis
of
potential
risk
from
lindane
treatment
of
head
lice
because
we
do
not
believe
that
there
is
sufficient
data
to
conduct
a
reasonable,
scientifically
sound
quantification
of
MOE's
associated
with
lindane
treatment
of
head
lice.
Critical
data
on
the
dermal
absorption
associated
with
the
short
application
interval
typical
of
lice
treatment
are
unavailable.
While
HED
has
data
on
dermal
absorption
of
lindane
associated
with
24
hour
exposure
periods
(
which
were
used
to
assess
potential
risk
from
treatment
of
scabies),
we
do
not
have
absorption
data
for
the
5
to
15
minute
exposure
duration
associated
with
head
lice
treatment.
HED
does
not
believe
that
the
24
hour
dermal
absorption
factors
derived
from
both
human
and
monkey
studies
is
applicable
to
5
to
15
minute
exposures,
nor
do
we
believe
is
possible
to
extrapolate
to
a
shorter
duration
factor
with
any
degree
of
certainty.
A
linear
extrapolation
of
dermal
absorption
from
24
hours
to
15
minutes
would
result
in
dermal
absorption
factors
well
below
any
of
those
used
in
the
analyses
submitted
by
commenters.
An
assumption
of
positive
linear
correlation
is
highly
uncertain,
however,
and
has
minimal
scientific
basis.
Commenters
submitting
MOE
assessments
also
tended
to
assume
that
the
amount
of
lindane
available
for
absorption
from
head
lice
treatment
was
the
same
as
that
for
scabies
treatment.
This
is
not
the
case
as
lindane
products
used
for
lice
treatment
are
applied
to
a
much
smaller
area
(
i.
e.,
the
scalp)
than
scabies
treatment
products,
which
are
applied
to
the
entire
body
below
the
neck.
There
are
clearly
uncertainties
associated
with
the
blood
level
analysis
HED
used
to
assess
potential
risks
from
use
of
lindane
to
treat
lice,
as
discussed
in
the
analysis.
However,
HED
believes
that
the
significant
difference
in
blood
levels
associated
with
acute
accidental
ingestion
which
resulted
in
short­
term
adverse
effects
versus
blood
levels
associated
with
label
prescribed
head
lice
treatment
(
0.00613
ug/
mL
vs
0.32
ug/
mL
respectively)
Attachment
A
A
­
3
indicates
that
label
prescribed
use
of
lindane
head
lice
products
does
not
pose
human
health
risks
of
concern.

Public
Comment:
NPA
argued
that
the
Agency
for
Toxic
Substances
and
Drug
Registration's
(
ATSDR's)
NOAEL
of
1
mg/
kg/
day
for
acute
oral
exposure
should
have
been
used
by
HED
in
its
assessment
of
risk
from
lindane
treatment
of
lice
and
scabies.
NPA
submitted
an
MOE
analysis
of
potential
risks
from
lice
treatment
in
which
it
compared
MOEs
derived
using
the
ATSDR
NOAEL
and
the
NOAEL
used
by
HED
in
its
analysis
of
risk
from
scabies
treatment.

HED
Response:
HED
used
a
NOAEL
of
6
mg/
kg/
day
based
on
an
acute
oral
toxicity
study
in
rats.
The
ATSDR
NOAEL
of
1
mg/
kg/
day
is
similarly
based
on
a
short­
term
oral
rat
study
(
4
days,
1
dose
per
day).
HED
believes
that
the
determination
of
similar
NOAELs
by
EPA
and
ATSDR
supports
the
endpoint
used
in
HED's
assessment
of
scabies
treatment.
Use
of
a
NOAEL
of
1
mg/
kg/
day
would
not
significantly
increase
the
very
low
MOE's
derived
in
HED's
assessment
of
scabies
treatment
nor
would
it
alter
HED's
conclusion
that
our
analysis
indicates
MOE's
of
concern
from
both
high
and
low­
end
treatment
scenarios
for
all
ages
assessed.
Regarding
NPA's
MOE
analysis
of
head
lice
treatment,
as
noted
in
the
response
to
the
previous
comment,
HED
does
not
believe
that
there
is
sufficient
data
to
conduct
a
reasonable,
scientifically
sound
quantification
of
MOE's
associated
with
lindane
treatment
of
head
lice.

Comments
on
Assessment
of
Occupational
Risk
Public
Comment:
Crompton
Corporation
argued
that
EPA
should
note
that
the
occupational
risks
associated
with
treatment
of
canola
seed
are
acceptable
if
respiratory
protection
is
required
of
the
seed
treaters.

HED
Response:
HED
agrees
that
use
of
respirators
during
treatment
of
canola
seed
would
result
in
MOEs
that
are
above
the
target
MOE
of
100
for
occupational
exposure
and
would
therefore
not
pose
risks
of
concern.
Attachment
B
B
­
1
PC
Code:
009001
DP
Code:
D287966
MEMORANDUM
DATE:
March
26,
2003
SUBJECT:
Response
to
Final
Comments
the
RED
Lindane
TO:
Betty
Shackleford,
Branch
Chief
Mark
T.
Howard,
Team
Leader
Special
Review
and
Reregistration
Division
(
7508C)

FROM:
Nicholas
E.
Federoff,
Wildlife
Biologist,
Team
Leader
Faruque
Khan,
Ph.
D.,
Environmental
Scientist
José
L.
Meléndez,
Chemist
Environmental
Risk
Branch
V
Environmental
Fate
and
Effects
Division
(
7507C)

THROUGH:
Mah
T.
Shamim,
Ph.
D.,
Chief
Environmental
Risk
Branch
V
Environmental
Fate
and
Effects
Division
(
7507C)

EFED
has
received
a
number
of
comments
from
the
registrant
as
well
as
other
interested
groups
and
individuals
regarding
the
RED
chapter.
EFED
comments
are
as
follows:

Comments
#
34
California
Regional
Water
Quality
Control
Board
(
CRWQCB)

The
USEPA
underestimates
discharge
during
environmentally
relevant
time
frames.
The
risk
assessment
should
be
structured
to
include
concentrations
estimated
on
1­
hour
and
four­
hour
frames,
as
well
as
lifetime
exposure
risk
estimates.

EPA
selected
results
from
a
statistical
distribution
for
the
estimation
of
lindane
drinking
water
concentrations.
The
10th
percentile
stream
dilution
factor
(
SDF)
was
recommended
to
represent
acute
concentrations
likely
to
be
found
in
drinking
waters,
while
50th
percentile
SDF
was
recommended
to
represent
chronic
concentrations.
EFED
should
again
indicate
that
these
recommendations
are
based
on
statistical
distribution
curves,
for
the
estimation
of
acute
and
Attachment
B
B
­
2
chronic
time
frames.
These
values
are
used
for
the
estimation
of
risk
of
exposure
to
humans,
according
to
the
Guidelines
for
Exposure
Assessment
(
USEPA,
1992a).

The
analysis
relies
on
dilution
in
estimating
surface
water
concentrations
of
pesticides.
However,
numerous
wastewater
treatment
plants
discharge
into
otherwise
dry
streams
or
into
shallow,
poorly
mixed
water
bodies
composed
primarily
or
their
effluent:

EFED's
purpose
was
to
estimate
concentrations
of
lindane
in
possible
sources
of
drinking
water.
It
is
doubtful
that
wastewaters
coming
directly
from
treatment
facility
or
plant
would
be
used
as
a
source
of
drinking
waters.

Comments
#
43
Crompton
Corporation
Lindane
does
not
break
down
into
pentachlorohexane,
but
into
pentachlorohexene:

This
issue
has
been
addressed
previously
under
DP
Barcode
D274510.
EPA
states
that
lindane
is
highly
persistent,
with
a
half­
life
of
2.6
years
in
soil,
while
studies
in
the
field
showed
shorter
half­
lives
of
25,
65,
and
107
days:

This
issue
has
been
addressed
previously
under
DP
Barcode
D274510.

Comments
#
47
Pesticide
Action
Network
North
America
(
PANNA),
and
Alaska
Community
Action
on
Toxics
(
ACAT)

PANNA
and
ACAT
suggest
that
The
Agency
does
not
have
sufficient
evidence
and/
or
data
to
suggest
that
mammals
will
be
averse
to
the
consumption
of
treated
seeds
and
analysis
of
endocrine
disrupting
effects
of
lindane
to
wildlife.

EFED
fully
agrees
with
PANNA
and
ACAT
and
has
stated
such
in
our
DRAFT
chapter.
We
do
have
data
regarding
possible
aversion
in
some
avian
species
but
none
for
mammalian
species.
In
addition,
we
have
strongly
suggested
from
available
data
that
lindane
may
be
an
endocrine
disrupting
compound
and
should
fully
be
tested
as
such
when
such
policy,
directives
and
procedures
become
available
within
The
Agency.

Comments
#
49
Beyond
Pesticides
Lindane
is
highly
persistent
in
soils
and
is
stable
in
both
fresh
and
salt
water.

The
issue
of
the
persistence
of
Lindane
in
soil
and
water
has
been
addressed
previously
in
the
RED
chapter
and
under
DP
Barcode
D274510.
Attachment
B
B
­
3
Lindane's
use
as
a
lice
and
scabies
treatment
and
its
endocrine
disrupting
properties
must
be
considered
in
the
assessment
of
ecological
risk.
Also,
EPA
can't
assume
that
mammals
will
express
the
same
aversion
to
eating
lindane
treated
seed
as
birds
do.

EFED
fully
agrees
with
BEYOND
PESTICIDES
and
has
stated
such
in
our
DRAFT
chapter.
We
do
have
data
regarding
possible
aversion
in
some
avian
species
but
none
for
mammalian
species.
In
addition,
we
have
strongly
suggested
from
available
data
that
lindane
may
be
an
endocrine
disrupting
compound
and
should
be
fully
tested
as
such
when
policy,
directives
and
procedures
become
available
within
The
Agency.
Regarding
risks
from
Lindane's
scabies
and
lice
use,
EFED
did
run
a
"
down
the
drain"
model
and
concluded
that
risk
from
any
additional
concentrations
was
very
minor
and
would
not
increase
the
aquatic
risk
substantially
more
than
already
stated
in
the
RED
chapter
.

Comments
#
54
County
Sanitation
Districts,
of
Los
Angeles
County
(
CSDs)

The
CSDs
indicate
that
the
EFED
memorandum
relied
upon
sales
rates
of
lindane
pharmaceuticals
and
theoretical
calculations
to
determine
lindane
loadings
to
surface
waters,
not
actual
effluent
concentrations
at
a
POTW.
The
EFED
reported
0.03
ppb
from
the
Publicly
Owned
Treatment
Works
(
POTWs)
of
Sanitation
Districts
of
Los
Angeles
County.
However,
CSDs
indicates
that
theoretical
calculations
were
used
while
actual
POTW
effluent
values
were
available
to
EPA.
Data
were
submitted
to
the
EPA
by
the
Districts,
including
474
influent
lindane
samples,
and
743
effluent
lindane
samples
(
from
1990
to
1999).
The
OPP
model
does
not
account
for
the
significant
variability
in
the
actual
data.
While
the
average
effluent
lindane
concentrations
among
the
wastewater
treatment
plants
varied
from
10
to
40
ppt,
maximum
effluent
lindane
concentrations
up
to
340
ppt
were
recorded.

The
application
of
the
10th
stream
dilution
values
to
determine
acute
risks
is
inappropriate.
Acute
risk
is
generally
defined
as
a
risk
based
on
short­
term
exposure,
not
a
risk
based
on
having
drinking
water
coming
from
a
lower
flow
stream.

OPP­
EFED
used
sales
data
of
pharmaceutical
usages
of
lindane
and
actual
POTW
effluent
values
of
lindane
for
the
year
of
2000
to
estimate
the
loadings
to
surface
waters.
The
estimated
concentrations
are
comparable
for
both
scenarios.
EFED
was
not
aware
of
743
effluent
lindane
concentrations
collected
during
1990
to
1999.
However,
using
the
reported
maximum
effluent
lindane
concentration
of
0.340
µ
g/
L
(
340
ppt),
the
estimated
acute
concentration
4.5E­
03
µ
g/
L)
and
chtonic
concentratino
(
3.4
E­
04
µ
g/
L)
are
many
fold
lower
than
the
DWLOC
(
Crinking
Water
Level
of
Comparison)
for
acute
(
170
µ
g/
L)
and
chronic
(
14
µ
g/
L)
concentrations
as
well
as
current
MCL
(
0.2
µ
g/
L)
for
lindane.

The
EPA
OPP
needs
to
prepare
a
parallel
document
that
considers
the
concentrations
of
lindane
in
surface
waters
that
are
not
sources
of
drinking
waters.
Attachment
B
B
­
4
In
general,
the
estimated
acute
and
chronic
concentrations
of
drinking
water
are
always
more
conservative
than
the
surface
waters
that
are
not
sources
of
drinking
waters.
Therefore,
the
estimates
of
acute
and
chronic
exposures
due
to
pharmaceutical
usages
of
lindane
in
non­
drinking
surface
water
bodies
will
be
lower
than
the
surface
water
sources
of
drinking
water.
EFED
believes
that
further
assessment
of
pharmaceutical
usages
of
lindane
in
non­
drinking
surface
water
is
not
warranted
at
this
time.

REFERENCE:
U.
S.
Environmental
Protection
Agency.
1992a.
Guidelines
for
Exposure
Assessment.
Federal
Register
57(
104):
22888
 
22938
Attachment
C
C
­
1
MEMORANDUM
SUBJECT:
Lindane;
Chemical
No.
009001.
OGC's
Response
to
Public
Comment
on
the
Lindane
Registration
Eligibility
Document
(
RED)

Reregistration
Case
#:
0315
FROM:
Gautam
Srinivasan
Attorney­
Advisor
Pesticides
and
Toxic
Substances
Law
Office
(
2333A)

THROUGH:
Kevin
Lee
Assistant
General
Counsel
Pesticides
and
Toxic
Substances
Law
Office
(
2333A)

TO:
Mark
Howard
Reregistration
Branch
3
Special
Review
&
Reregistration
Division
(
7508C)

This
memorandum
responds
to
a
comment
submitted
by
Syngenta
Crop
Protection,
Inc.
on
the
Lindane
Registration
Eligibility
Document.

Comment:
Syngenta
Crop
Protection,
Inc.
("
Syngenta")
objected
to
the
use
of
an
occupational
exposure
study
(
the
"
Helix
Study")
conducted
by
Syngenta
to
support
the
registration
of
the
active
ingredient
thiamethoxam.
Syngenta
stated
that
the
Helix
Study
meets
the
statutory
and
regulatory
criteria
for
exclusive
use
protection.
Because
the
Helix
Study
is
an
exclusive
use
study,
Syngenta
argued
it
was
unlawful
for
EPA
to
use
the
Helix
Study
to
evaluate
certain
on­
farm
seed
treatment
uses
of
lindane.
Syngenta
asked
that
EPA
remove
all
references
to
the
Helix
Study
from
the
lindane
RED
and
that
EPA
not
reregister
any
remaining
uses
of
lindane
until
acceptable
occupational
exposure
data
are
provided
to
EPA.

Response:
EPA
disagrees
with
Syngenta
with
regard
to
use
of
the
Helix
Study.
EPA
is
not
limited
in
the
data
it
may
consider
when
making
a
risk­
benefit
determination
in
connection
with
the
development
of
a
reregistration
eligibility
determination
for
a
particular
pesticide.
EPA
has
long
drawn
a
distinction
between
data
that
must
be
submitted
to
satisfy
the
requirements
of
40
CFR
part
158,
and
data
that
may
be
reviewed
to
make
a
risk­
benefit
determination.
EPA
has
stated
that
when
reviewing
the
risk­
benefit
criteria,
"
EPA
may
consider
any
relevant
data
without
regard
to
who
submitted
the
data,
for
what
purpose,
or
when
the
data
were
submitted."
49
FR
30884,
30888
(
Aug.
1,
1984).
This
includes
review
of
exclusive
use
data.
When,
however,
EPA
reviews
individual
products
to
determine
whether
they
have
complied
with
the
data
requirements
of
registration
or
reregistration,
EPA
will
ensure
that
the
registrants
of
such
products
submit
or
cite
required
studies.
Attachment
C
C
­
2
The
fact
that
EPA
reviews
an
exclusive
use
study
in
making
a
risk­
benefit
determination
in
a
RED
document
does
not
deny
the
data
owner
the
protections
afforded
by
FIFRA.
The
economic
interests
of
the
data
submitter
are
protected
through
the
registration
and
reregistration
of
individual
products.
It
is
in
connection
with
those
activities
that
EPA
must
determine
whether
an
applicant
or
registrant
has
submitted
or
cited
data
required
for
the
registration
or
continued
registration
of
the
pesticide
product.

An
applicant
for
registration
or
reregistration
may
not
satisfy
a
40
CFR
part
158
requirement
by
citing
an
exclusive
use
study.
EPA
explained
this
in
detail
in
the
1984
FR
notice:
"
The
prohibition
against
unauthorized
citation
of
an
exclusive
use
study
applies
only
to
an
applicant's
right
to
cite
another's
study
in
his
application
for
registration,
not
to
the
Agency's
review
of
data
to
determine
whether
or
not
the
pesticide
should
be
registered
on
risk/
benefit
grounds.
The
Agency's
review
of
data
for
this
purpose
in
no
way
negates
or
compromises
the
rights
of
the
exclusive
use
data
submitter
or
undermines
the
intent
of
Congress
in
providing
such
protection.
A
second
applicant
who
wishes
to
cite
the
exclusive
use
study
must
obtain
the
written
authorization
of
the
exclusive
use
data
submitter.
If
permission
is
denied,
the
second
applicant
is
not
precluded
from
entering
the
market,
but
must
first
replicate
the
necessary
data
or
obtain
it
from
another
source.
Thus,
the
exclusive
use
data
submitter
is
assured
that
no
competitor
enters
the
market
without
either
having
his
permission
to
cite
data
submitted
to
EPA
(
which
he
may
condition
upon
the
payment
of
royalties
or
compensation)
or
having
generated
(
or
otherwise
acquired)
at
least
the
equivalent
set
of
data
required
for
registration."
49
FR
at
30888.

Therefore,
it
was
not
unlawful
for
EPA
to
utilize
the
Helix
Study
in
making
the
risk­
benefit
determination
captured
in
the
lindane
RED.
EPA
will
not
remove
references
to
the
Helix
Study
from
the
lindane
RED.
Such
references
do
not
violate
or
compromise
Syngenta's
exclusive
use
protection.
EPA
will,
however,
ensure
appropriate
protection
for
any
data
required
for
specific
product
registration
or
reregistration
in
connection
with
product
registration
and
reregistration
activities.
Attachment
D
D
­
1
List
of
organizations
submitting
comments
on
the
2002
Lindane
RED
(
OPP­
2002­
0202):

Various
Private
Citizens
California
Regional
Water
Quality
Control
Board
County
Sanitation
Districts
of
Los
Angeles
Technology
Sciences
Group,
Inc.

Consumer
Specialty
Products
Assoc.
(
CSPA)

Pesticide
Action
Network
North
America
(
PANNA)

Consumers
Union
Beyond
Pesticides
Syngenta
Crop
Protection,
Inc.

National
Pediculosis
Association
American
Chemistry
Council
Natural
Resources
Defense
Council
(
NRDC)

State
of
New
York;
Office
of
the
Attorney
General