Document ID: EPA-HQ-OPP-2002-0138-0018
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2002-07-31T04:00Z

UNITED
STATES
ENVIRONMENTAL
PROTECTION
AGENCY
WASHINGTON,
D.
C.
20460
OFFICE
OF
PREVENTION,
PESTICIDES,
AND
TOXIC
SUBSTANCES
DP
Barcode:
D276945
PCCode:
056801
Date:
August
17,
2002
MEMORANDUM:

SUBJECT:
Response
to
Registrant's
30­
day
Error
Correction
Comments
on
the
EFED
Risk
Assessment
Chapter
in
Support
of
the
Reregistration
Eligibility
Decision
(RED)
on
Carbaryl
To:
Anthony
Britten,
PM
Team
Reviewer
Betty
Shackleford,
Product
Manager
53
Special
Review
and
Reregistration
Division
(7508C)

FROM:
E.
Laurence
Libelo,
Ph.
D.,
Environmental
Engineer
Thomas
Steeger,
Ph.
D.,
Senior
Biologist
Environmental
Risk
Branch
IV
Environmental
Fate
and
Effects
Division
(7507C)
Angel
Chiri,
Ph.
D.,
Biologist
Biological
and
Economic
Assessment
Division
THRU:
Betsy
Behl,
Chief
ERB
IV/
EFED
(7507C)

The
Environmental
Fate
and
Effects
Division
(EFED)
has
reviewed
the
registrant
30­
day
(Phase
I)
error
response
from
Aventis
CropScience
entitled
"Review
of
the
Draft
Environmental
Fate
and
Ecological
Risk
Assessment
of
the
Reregistration
of
Carbaryl."
EFED
has
revised
its
risk
assessment
for
the
reregistration
eligibility
decision
(RED)
and
is
attaching
the
revised
document.
Revisions
to
the
chapter
(identified
below)
reflect
only
those
instances
where
an
actual
error
was
identified.
Comments
from
the
registrant
that
did
not
identify
an
actual
error
but
rather
were
editorial
in
nature
will
be
addressed
after
the
public
comment
period
(Phase
II)
has
ended.
However,
several
generic
issues
were
raised
by
the
registrant
that
EFED
would
like
to
comment
on.
These
include
endocrine
disruption,
the
use
of
open
literature
to
supplement
core
data
submissions,
status
of
Aventis'
water­
monitoring
studies,
and
the
role
of
new
data
submissions
in
characterizing
risk
in
the
current
version
of
the
RED.

Endocrine
Disruption
The
risk
assessment
chapter
is
not
intended
to
resolve
the
endocrine
disrupting
potential
of
carbaryl.
Rather,
the
chapter
summarizes
available
ecological
effect
data;
EFED
believes
there
are
sufficient
data
to
raise
concern
regarding
the
endocrine
disrupting
potential
of
carbaryl.
EFED
is
required
to
identify
effects
that
it
believes
are
consistent
with
responses
to
endocrine­
mediated
pathways.
Those
chemicals
identified
as
potential
endocrine
disruptors
such
as
carbaryl,
will
likely
be
subject
to
more
refined
testing
for
such
effects
once
the
appropriate
testing
procedures
have
been
2
identified.
However,
at
this
stage
of
the
process
EFED
is
simply
identifying
potential
endocrine
disruptors.

Open
Literature
Open
literature
studies
are
not
intended
to
fulfill
guideline
data
requirements
but
rather
they
are
intended
to
help
reduce
uncertainty
and
support
concerns
regarding
risk.
Additionally,
EFED
relies
on
open
literature
from
peer­
reviewed
journals
that
require
proposed
publications
to
undergo
the
scrutiny
of
review
prior
to
release
to
the
general
public.
The
registrant
contends
that
toxicity
data
obtained
from
published
literature
are
".
.
.
at
times
at
least
questionable
and
other
times
does
not
fulfill
the
requirements
set
by
EPA
for
studies
submitted
by
the
registrant.
Data
of
such
poor
quality
should
not
be
used
as
key
information
in
the
risk
assessment."
EFED
has
routinely
relied
on
published
literature
particularly
in
cases
where
there
are
insufficient
core
data
and/
or
the
existing
data
introduce
considerable
uncertainty
into
the
risk
assessment
process.
In
general,
published
literature
is
drawn
from
peer
reviewed
journals;
while
EFED
does
not
have
access
to
the
original
data
on
which
these
studies
are
based,
it
is
assumed
that
the
study
conclusions
have
undergone
some
degree
of
scientific
scrutiny
to
warrant
publication.

Status
of
Aventis'
Drinking
Water
Monitoring
Studies
The
registrant
makes
repeated
reference
to
the
drinking
water
monitoring
study
data
that
were
submitted.
The
study
is
very
limited
in
scope
and
it
is
unclear
how
sites
that
were
monitored
relate
to
locations
where
carbaryl
has
been
used
nationally.
It
is
extremely
unlikely
that
this
study
sampled
peak
concentrations.
In
addition,
the
study
design
did
not
allow
EFED
to
evaluate
the
effect
of
drinking
water
treatment
on
carbaryl
concentrations.
The
study
is
also
of
only
limited
usefulness
for
determining
concentrations
in
surface
water
for
use
in
ecological
exposure
assessment.
Water
bodies
represented
in
the
study
are
generally
larger
then
those
of
concern
for
ecological
exposure.
The
limitations
on
this
study
have
been
discussed
in
the
reviews
of
the
study
interim
reports.

Additional
Data
In
several
instances,
the
registrant
references
recently
submitted
data
as
addressing
uncertainties
characterized
in
the
RED.
Since
these
data
were
not
available
when
the
draft
RED
was
written,
they
were
not
captured
in
the
RED.
Depending
on
the
quality
of
the
new
data,
they
may
be
included
in
the
RED
after
they
have
been
reviewed.
However,
the
30­
day
error
response
phase
is
not
intended
to
represent
an
opportunity
to
submit
additional
data.
Additionally,
if
data
are
provided
that
demonstrate
that
certain
environmental
fate
and
ecological
effects
endpoints
might
be
substantially
different
than
those
used
in
the
RED,
it
does
not
discount
the
reliability
and/
or
utility
of
the
original
studies.
For
example,
if
the
newly
submitted
2­
generation
rat
study
provides
a
no­
observe
effect
concentration
which
is
significantly
less
sensitive
than
the
endpoint
used
from
the
rat
developmental
study,
then
it
is
likely
that
EFED
would
continue
to
use
the
results
of
the
original
developmental
study,
i.
e.,
the
most
sensitive
endpoint,
to
evaluate
chronic
toxicity.
In
the
attached
document
(Attachment
A)
each
of
the
registrant's
comments
is
addressed.
The
attachment
is
in
three
sections,
i.
e.,
General
Comments,
Transmittal
and
RED
Document
Line­
by­
Line
Review
of
the
Carbaryl
RED
Chapter,
and
Discussion.
In
the
line­
by­
line
review,
the
registrant
cites
specific
EPA
comments
and
then
provides
their
response
to
the
comment.
In
all
three
sections,
the
EFED
response
to
discussions
and/
or
comments
is
entitled
"EFED
Response".
In
many
cases
the
registrant
has
provided
constructive
comments
on
the
EFED
science
chapter
and
has
helped
to
assure
the
document's
accuracy.
Overall
though,
the
registrant's
comments
have
not
affected
the
basic
3
concerns
and
uncertainties
identified
in
environmental
fate
and
ecological
effects
assessment
of
carbaryl.
4
Attachment
A.
EFED
Responses
to
30­
day
Error
Correction
Comments
by
Registrant
CARBARYL
PC
Code
No.
056801;
Case
0080
Review
of
the
Draft
Environmental
Fate
and
Ecological
Risk
Assessment
for
the
Reregistration
of
Carbaryl
August
6,
2001
Aventis
CropScience
P.
O.
Box
12014,
2
T.
W.
Alexander
Drive
Research
Triangle
Park,
NC
27709
5
General
Comments
The
EFED
draft
chapter
of
the
carbaryl
RED
is
very
thorough
using
a
wealth
of
references.
The
use
of
published
literature
over
submitted
data
is
significant.
The
quality
of
the
published
literature
is
at
times
at
least
questionable
and
other
times
does
not
fulfill
the
requirements
set
by
EPA
for
studies
submitted
by
the
registrant
(e.
g.
thorough
description
of
test
conditions,
clear
identification
of
the
test
material,
analytical
verification,
GLP
etc.).
Data
of
such
poor
quality
should
not
be
used
as
key
information
in
the
risk
assessment.
For
the
30­
day
response
not
all
literature
references
could
be
verified
or
the
quality
ascertained.

EFED
Response:

EFED
feels
that
all
available
relevant
information
should
be
used
in
evaluating
risk
of
pesticides
with
long
registration
histories.
As
in
other
risk
assessments
literature
data
were
used
to
supplement
and
to
help
evaluate
registrant
submitted
data.
Literature
data
were
also
used
when
required
core
data
were
not
submitted.
Literature
data
were
evaluated
by
EFED
scientists
prior
to
the
data's
inclusion
into
the
risk
assessment
and
data
of
questionable
validity
were
not
used.

There
is
a
high
level
of
redundancy
in
the
document
making
it
difficult
to
read.
Reducing
repetitions
to
a
minimum
would
facilitate
the
reading.

EFED
Response:

While
EFED
agrees
that
the
chapter
includes
some
redundancy,
this
does
not
represent
a
factual
error
in
the
document.
EFED
has
found
utility
in
repeatedly
emphasizing
certain
themes
to
underscore
concern
or
uncertainty.

We
believe
it
is
inappropriate
to
include
DERs
[data
evaluation
records]
in
the
RED
Chapters.
A
summary
of
study
findings
is
already
presented
in
the
document.
DERs
should
be
made
available
to
the
public
through
the
regular
procedure
under
the
Freedom
of
Information
Act
after
they
have
been
reviewed
and
cleared
for
confidential
business
information.

EFED
Response:

EFED
concurs
with
the
registrant's
comments
that
DERs
should
be
made
available
to
the
public
under
the
Freedom
of
Information
Act
after
they
have
been
reviewed
and
cleared
for
confidential
business
information.

The
use
of
carbaryl
on
barley,
oats,
rye,
cotton,
and
livestock
are
cancelled
.
It
should
be
noted
that
Aventis
CropScience
labels
for
the
technical
materials
and
the
end­
use
products
containing
carbaryl
were
amended
to
delete
these
uses.
The
Agency
has
already
approved
the
labeling
changes
(please
refer
to
HED
response
document,
Section
III
for
details).
6
EFED
Response:

The
cancelled
uses
have
been
removed.
The
document
reflects
uses
that
were
supported
at
the
time
the
chapter
was
written;
EFED
does
not
have
the
resources
to
revise
chapters
to
remain
consistent
with
current
mitigation
measures;
however
the
chapter
does
provide
a
better
understanding
of
why
certain
mitigation
agreements
were
reached.

Aventis
CropScience
will
no
longer
support
the
use
of
carbaryl
on
poultry
(direct
application
and
poultry
quarters
treatment).
We
will
shortly
submit
a
request
for
cancellation
of
these
uses
in
accordance
with
section
6(
f)(
1)
of
the
Federal
Insecticide,
Fungicide
and
Rodenticide
Act
(FIFRA)
(please
refer
to
HED
response
document,
Section
III
for
details).

Aventis
CropScience
is
in
the
process
of
conducting,
or
has
scheduled,
studies
relevant
to
the
refinement
of
the
environmental
risk
assessments
for
carbaryl
and
the
major
degradate
1­
naphthol.
These
studies
are
as
follows:
C
Rate
and
Route
of
Aerobic
Degradation
in
Soils.
These
studies
have
been
initiated
with
parent
carbaryl
applied
to
four
diverse
U.
S.
soils.
The
data
are
intended
to
provide
additional
half­
life
determinations
for
parent
carbaryl
and
the
major
degradate
1­
naphthol.
Expected
completion
date:
March
2002
C
Aerobic
Aquatic
Metabolism
in
Two
Water/
Sediment
Systems.
These
studies
have
been
initiated
with
parent
carbaryl
applied
to
two
distinct
U.
S.
water/
sediment
systems.
The
data
are
intended
to
provide
additional
half­
life
determinations
for
parent
carbaryl
and
the
major
degradate
1­
naphthol.
In
addition,
further
identification
of
additional
degradation
products
is
anticipated.
Expected
completion
date:
March
2002
C
Adsorption
and
Desorption
of
1­
Napthol
to
five
soils.
This
study
has
been
scheduled
to
evaluate
the
adsorption
and
desorption
of
the
major
carbaryl
degradate
to
five
soils/
sediment.
The
data
are
intended
to
provide
information
necessary
to
evaluate
the
environmental
risks
from
1­
naphthol
in
standard
models.
Expected
completion
date:
March
2002
EFED
Response:

These
studies
will
be
reviewed
and
evaluated
when
they
are
received
and
if
the
studies
are
determined
to
be
scientifically
valid,
they
will
be
used
in
future
assessments.

For
the
reregistration
process
in
the
EU,
Aventis
CropScience
is
in
the
process
of
conducting,
or
has
scheduled,
studies
relevant
to
the
refinement
of
the
ecotoxicological
risk
assessments
for
carbaryl
and
the
major
degradate
1­
naphthol.
These
studies
are
as
follows:

Studies
with
Carbaryl:
Acute
oral
LD50
in
mallard
ducks
Dynamic
acute
LC50
in
bluegill
sunfish
Acute
toxicity
in
Daphnia
7
Acute
toxicity
in
Chironomus
riparius
Toxicity
in
Selenastrum
capricornutum
Acute
oral
and
contact
toxicity
in
honeybees
14­
d
toxicity
in
earthworms
Effects
on
soil
microorganisms
(nitrification/
carbon
cycle)
Effect
on
sewage
treatment
Studies
with
1­
naphthol
Early
life­
stage
study
in
fathead
minnow
Acute
toxicity
in
Daphnia
Acute
toxicity
in
Daphnia
in
presence
of
sediment
Chronic
toxicity
in
Daphnia
14­
d
toxicity
in
earthworms
Formulated
Product
Vegetative
Vigor
Toxicity
in
Selenastrum
capricornutum
Acute
oral
and
contact
toxicity
in
honeybees
Effect
on
non­
target
arthropods
14­
d
toxicity
in
earthworms
Effects
on
soil
microorganisms
(nitrification/
carbon
cycle)

Ecotoxicological
Risk
Assessments
Aventis
has
pointed
out
several
errors
in
the
PRZM
input
parameters
(see
comments
made
to
Tables
5
and
6
of
the
draft
RED),
overly
conservative
estimates
of
foliar
dissipation
half­
lives
and
changes
in
ecotoxicology
study
endpoints.
This
indicates
that
a
re­
calculation
of
the
EECs
and
risk
quotients
are
warranted
in
a
number
of
instances.

EFED
Response:

EFED
has
reviewed
the
estimated
environmental
concentrations
[EECs]
and
does
not
agree
with
Aventis'
perspective
on
PRZM
input
parameters.
Specific
comments
are
addressed
in
the
appropriate
sections
below.

Endocrine
Disruption
Reports
in
the
open
literature
on
the
reproductive
effects
of
carbaryl
in
wild
mammals
are
at
best
ambivalent.
The
recently
submitted
2­
generation
study
in
rats
demonstrates
the
absence
of
reproductive
effects.
As
EPA
pointed
out,
findings
reported
in
the
literature
were
made
at
concentrations
well
above
the
highest
peak
concentration
modeled.
Therefore
these
findings
are
irrelevant
for
a
risk
assessment
and
at
the
current
stage
of
discussion
about
endocrine
disruption.
If
the
concern
about
the
endocrine
potential
of
carbaryl
persists,
the
issue
should
be
revisited
once
the
Agency's
endocrine
disrupter
screening
and
testing
program
as
well
as
a
policy
on
how
to
8
incorporate
positive
findings
into
an
ecological
risk
assessment
have
been
fully
developed.

EFED
Response:

The
ecological
risk
assessment
does
not
conclude
that
carbaryl
is
an
endocrine
disrupter.
EFED
has
cited
open
literature
and
has
noted
effects
in
chronic
reproduction
studies
that
are
consistent
with
endocrine­
mediated
effects.
EFED
is
uncertain
regarding
the
endocrine
disrupting
capacity
of
carbaryl
and
is
therefore
requesting
additional
data
when
the
appropriate
testing
procedures
have
been
identified.

Mobility
The
classification
of
carbaryl
as
mobile
to
very
mobile
is
inconsistent
with
measured
Koc
values
of
177
to
249
(MRID
43259301).
According
to
the
widely
used
classification
scheme
of
McCall,
et
al.
(1980)
wherein
Koc
values
between
150
and
500
denote
medium
mobility
in
soil,
carbaryl
would
be
classified
as
having
medium
mobility
in
most
soils.
This
classification
of
medium
mobility
is
further
supported
by
the
acceptable
column
leaching
study
(MRID
43320701)
in
which
aged
carbaryl
residues
were
only
slightly
mobile
in
a
number
of
soils.
The
mobility
of
carbaryl
would
be
expected
to
be
higher
in
sandy
soils
or
in
soils
of
low
organic
matter.

EFED
Response:

There
are
a
number
of
classification
schemes
available
and
EFED
does
not
agree
that
Macall
et
al
1980
is
the
definitive
one.
However,
EFED
has
revised
the
chapter
to
read
that
"Carbaryl
is
considered
to
be
moderately
mobile
in
soils."

1­
Napthol
Fate
and
Transport
The
Agency
is
requiring
additional
information
on
the
persistence
and
mobility
of
1­
naphthol,
a
major
environmental
degradate
of
carbaryl.
However,
a
half­
life
for
1­
naphthol
of
less
than
1
day
can
be
calculated
from
the
carbaryl
aerobic
soil
metabolism
study
(MRID
42785101).
The
data
from
this
study
demonstrate
that
under
aerobic
soil
conditions
the
formation
and
decline
of
1­
naphthol,
starting
from
parent
carbaryl,
is
complete
in
less
than
14
days.
This
half­
life
can
be
used
for
preliminary
environmental
fate
modeling
to
estimate
EECs
for
1­
naphthol.

EFED
Response:

Based
on
the
aerobic
soil
metabolism
study
of
carbaryl
it
does
appear
that
1­
naphthol
degrades
rapidly.
However,
there
are
a
number
of
processes
occurring
simultaneously
in
the
test
system.
It
is
not
possible
to
solve
for
the
multiple
degradation
and
sorption/
desorption
rate
constants
from
the
limited
data
provided.
The
registrant
is
encouraged
to
provide
additional
data
to
resolve
this
uncertainty.

The
EPA
suggested
that
1­
naphthol
is
not
strongly
sorbed
to
soil.
Additional
information
available
in
the
literature
demonstrates
that
the
sorption
of
1­
naphthol
to
soil
is
stronger
than
that
seen
for
9
carbaryl
itself.
Hassett
et
al.
(1981)
has
demonstrated
that
the
sorption
of
1­
naphthol
was
the
result
of
sorption
to
organic
carbon
resulting
in
Koc
values
between
431
and
15,618.
These
data
indicate
that
1­
naphthol
is
less
mobile
and
less
susceptible
to
leaching
than
carbaryl
itself,
and
they
demonstrate
that
at
least
a
portion
of
the
1­
naphthol
residue
is
tightly
sorbed
to
soil
constituents.
(A
copy
of
this
article
is
being
submitted
with
the
response
to
the
draft
RED.)
To
meet
the
requirement
for
information
on
the
adsorption
and
desorption
of
1­
naphthol
by
the
Agency,
the
registrant
is
conducting
an
adsorption/
desorption
study
to
meet
the
163­
1
guideline.
Study
results
should
be
available
for
submission
to
the
Agency
in
the
first
quarter
of
the
calendar
year
2002.

EFED
Response:

EFED
will
review
the
data
on
the
mobility
of
1­
naphthol
when
it
is
submitted.
EFED
agrees
that
literature
data
indicated
that
the
degradate
is
less
mobile
then
the
parent.

Surface
Water/
Drinking
Water
Aventis
disagrees
with
EPA
that
the
modeling
simulations
provide
a
conservative,
though
not
unreasonable,
estimate
on
possible
concentrations
in
drinking
water.
Drinking
water
concentrations
derived
from
PRZM/
EXAMS
greatly
overestimate
the
potential
exposure
to
carbaryl
in
drinking
water,
generally
by
several
orders
of
magnitude.
Results
from
the
drinking
water
monitoring
program
conducted
by
the
registrant
provides
a
`real
world'
assessment
of
the
potential
for
human
exposure
to
carbaryl
in
drinking
water
derived
from
surface
water.

EFED
Response:

EFED
has
reviewed
the
registrant's
drinking
water
survey,
and
has
discussed
its
limitations
in
the
RED
chapter
and
elsewhere.
The
study
is
very
limited
in
scope
and
it
is
unclear
how
sites
that
were
monitored
relate
to
locations
where
carbaryl
has
been
used
nationally.
It
is
extremely
unlikely
that
this
study
sampled
peak
concentrations.
Until
a
detailed
description
of
how
the
sampling
locations
were
chosen
and
how
those
sites
relate
to
the
rest
of
the
country
has
been
evaluated,
it
is
not
possible
to
use
this
small­
scale
study
in
our
assessment.
This
information
was
submitted
as
part
of
the
registrant's
30­
day
comment
period
response.
It
will
be
reviewed
along
with
other
submitted
data
and
included
in
future
risk
assessments.

Ground
Water
EPA
summarized
information
on
the
detection
of
carbaryl
in
groundwater
from
the
EPA
Pesticides
in
Groundwater
Database,
the
EPA
STORET
database
and
the
NAWQA
database.
Each
of
the
databases
shows
a
pattern
of
very
low
levels
of
carbaryl
detection
in
few
groundwater
resources.
These
analyses
confirm
several
statements
made
by
the
Agency
that
carbaryl
has
limited
potential
to
impact
groundwater
resources.
However,
on
page
2
of
the
Memorandum
issued
June
28,
2001,
in
conjunction
with
the
EFED
RED
chapter
for
carbaryl,
EPA
is
requiring
additional
information
on
"surface
and
groundwater
monitoring
in
urban
and
suburban
use
areas
(non­
guideline)."
Based
on
the
characteristics
of
carbaryl
and
the
available
data
demonstrating
limited
impact
of
carbaryl
on
ground
water
resources,
additional
studies
to
evaluate
the
potential
for
carbaryl
to
contaminate
10
groundwater
are
unnecessary
and
unwarranted.

EFED
Response:

Carbaryl
use
in
agricultural
setting
is
expected
to
have
only
limited
impact
on
groundwater
resources.
However,
because
of
its
widespread
use
by
homeowners,
it
is
likely
that
groundwater
impacts
will
be
greatest
in
residential
settings.
EFED
does
not
require
additional
data
for
groundwater
contamination
evaluation
(e.
g.
prospective
groundwater
studies)
for
agricultural
uses
but
does
for
residential
use.
11
Line­
by­
Line
Review
of
the
Carbaryl
EFED
RED
Chapter
Transmittal
Document
Data
Gaps
Environmental
Fate
and
Transport
Page:
2
Paragraph:
1
Line:
1
EPA
comment:

Fate
information
on
the
degradation
product
1­
naphthol
is
required.

1.
Mobility
–
adsorption
and
desorption
studies
for
the
1­
naphthol
degradate
(163­
1)
2.
Persistence
–
aerobic
soil
metabolism
study
on
1­
naphthol
Aventis'
response:

Literature
data
(Hassett
et
al.
1981)
on
the
adsorption
of
1­
naphthol
are
provided
in
this
response.
Aventis
is
in
the
process
of
conducting
an
additional
adsorption/
desorption
study
on
1­
naphthol
and
intends
to
submit
study
data
to
EPA
by
March
2002.

The
degradation
of
1­
naphthol
under
aerobic
soil
conditions
has
been
widely
reported
in
the
literature.
Several
citations
are
included
in
the
EPA
draft
RED.
The
half­
life
of
1­
naphthol
estimated
from
the
acceptable
aerobic
soil
persistence
study
on
carbaryl
(MRID
42785101)
is
less
than
1
day.
Aventis
is
conducting
additional
laboratory
aerobic
soil
degradation
studies
on
carbaryl
that
will
be
used
to
provide
additional
determinations
of
the
half­
life
for
the
degradate
1­
naphthol
and
satisfy
the
Agency's
requirement
for
data
on
the
persistence
of
1­
naphthol.
Aventis
intends
to
submit
these
study
data
to
EPA
by
March
2002.

EFED
Response:

EPA
will
review
and
evaluate
the
new
data
when
it
is
submitted
and
will
incorporated
it
into
future
risk
assessments.

From
the
aerobic
soil
study
it
does
appear
that
1­
naphthol
degrades
rapidly.
However,
there
are
a
number
of
processes
occurring
simultaneously
in
the
test
system,
and
it
is
not
possible
to
solve
for
the
multiple
degradation
and
sorption/
desorption
rate
constants
from
the
limited
data
provided.

Water
Resources
Page:
2
Paragraph:
3
and
4
EPA
comment:
"EFED
believes
that
adequate
data
are
available
to
support
the
conclusions
reached
for
carbaryl's
impact
on
surface
water
and
groundwater
quality
with
the
exceptions
noted
below.
Additional
information
is
needed
to
characterize
the
impact
of
the
degradate
1­
naphthol
[in]
groundwater
and
surface
water.
ÿ
Surface
and
groundwater
monitoring
in
urban
and
suburban
use
areas
(non­
guideline)"
are
required.
12
Aventis'
response:

The
surface
water­
monitoring
program
conducted
by
Aventis
includes
monitoring
in
urban
and
suburban
use
areas.
Aventis
believes
that
the
need
for
information
on
the
degradate
1­
naphthol
will
be
satisfied
by
the
aerobic
soil
and
adsorption/
desorption
data
that
will
be
submitted
to
the
Agency.
These
data
can
be
used
to
evaluate
the
availability
of
1­
naphthol
using
established
EPA
modeling
guidelines.
The
Agency's
proposed
requirement
for
groundwater
monitoring
is
unnecessary
and
is
addressed
in
Aventis'
response
to
Agency
comments
in
the
draft
RED.

EFED
Response:

EFED
will
review
all
additional
data
when
they
are
submitted.
New
data
will
be
included
in
future
risk
assessments.

EFED
has
reviewed
this
small­
scale
study
and
does
not
agree
with
the
registrant's
assessment.
The
limitations
of
the
study
have
been
described
in
the
RED
chapter.

Ecological
Effects
Data
requirement
Page:
2
EPA
comment:
The
ecological
toxicity
database
is
complete
except
for:
6.
Aquatic
Plant
Growth
Guideline
122­
2
Aventis'
response:
The
data
requirement
should
be
deleted.
Aquatic
plant
growth
studies
were
submitted
to
the
Agency
in
1992.
An
October
04,
2000
OPP
Guideline
Status
Report
(Chemical
Review
Management
System)
lists
the
guideline
122­
2
status
as
"Acceptable/
Satisfied".
The
studies
are:

MRID
No.
Title
Acceptability
Code
42372101
Lintott,
D.
(1992)
Carbaryl
Technical:
Acute
Toxicity
To
The
Freshwater
Blue­
Green
Alga,
Anabaena
flos­
aquae,
Under
Static
Test
Conditions:
Lab
Project
Number:
J9112004E.
Unpublished
Study
Prepared
By
Toxikon
Environmental
Sciences.
53
P.
June
25,
1992
Upgradable
42372102
Lintott,
D.
(1992)
Carbaryl
Technical:
Acute
Toxicity
To
Duckweed,
Lemna
gibba
G3,
Under
Static
Test
Conditions:
Lab
Project
Number:
J9112004G.
Unpublished
Study
Prepared
By
Toxikon
Environmental
Sciences.
53
P.
January
1,
1992
Upgradable
42372802
Lintott,
D.
(1992)
Carbaryl
Technical:
Acute
Toxicity
To
The
Freshwater
Green
Alga,
Selenastrum
capricornutum
Under
Static
Conditions:
Lab
Project
Number:
J9112004C.
Unpublished
Study
Prepared
By
Toxikon
Environmental
Sciences.
53
P.
June
9,
1992
Acceptable
MRID
No.
Title
Acceptability
Code
13
42431601
Lintott,
D.
(1992)
Carbaryl
Technical:
Acute
Toxicity
To
The
Freshwater
Diatom,
Navicula
pelliculosa,
Under
Static
Test
Conditions:
Lab
Project
Number:
J9112004F.
Unpublished
Study
Prepared
By
Toxikon
Environmental
Sciences.
52
P.
August
10,
1992
Acceptable
42431602
Lintott,
D.
(1992)
Carbaryl
Technical:
Acute
Toxicity
To
The
Saltwater
Diatom,
Skeletonema
costatum,
Under
Static
Test
Conditions:
Lab
Project
Number:
J9112004D.
Unpublished
Study
Prepared
By
Toxikon
Environmental
Sciences.
49
P.
August
10,
1992
Supplemental
EFED
Response:

EPA
requires
data
on
5
aquatic
plant
species.
Only
two
of
the
five
species
provided
data
that
were
classified
as
acceptable
and
as
having
fulfilled
guideline
test
requirements.
Therefore,
EFED
is
requesting
that
aquatic
plant
studies
are
repeated
following
EPA
guidelines.

Page:
2
EPA
comment:
The
ecological
toxicity
database
is
complete
except
for:
7.
Submission
of
a
FETOX
amphibian
toxicity
study
is
required.
Aventis'
response:
The
data
requirement
should
be
deleted.
From
the
published
results
it
is
evident
that
carbaryl
is
practically
non­
toxic
to
the
bullfrog.
Effects
in
plain
leopard
frogs
are
reported
at
levels
well
above
environmental
concentrations.
These
results
were
obtained
testing
U.
S.
native
species.
In
the
proposed
FETOX
assay,
a
non­
native
species
Xenopus
laevis
is
used.
This
African
species
is
unique
in
its
behavior.
Neither
the
species
nor
the
test
methods
are
suitable
for
ecotoxicological
purposes.
As
the
risk
to
amphibians
can
be
evaluated
from
the
studies
cited,
and
as
the
effects
are
only
at
levels
well
above
the
EEC,
this
study
should
not
be
required.

EFED
Response:

While
EFED
is
concerned
about
the
documented
effects
of
carbaryl
on
native
frogs,
it
will
not
require
the
FETOX
study
at
this
time.
However,
when
appropriate
test
methods
have
been
developed
for
demonstrating
endocrine
disrupting
effects,
EFED
will
request
that
carbaryl
undergo
these
tests
to
better
understand
the
developmental
toxicity
of
carbaryl.
14
Label
Information
Page:
3
EPA
comment:
For
terrestrial
and
residential
uses:
1.
"Do
not
apply
directly
to
water,
or
to
areas
where
surface
water
is
present
or
to
intertidal
areas
below
the
mean
high
water
mark.
Do
not
contaminate
water
when
disposing
of
equipment
washwater
or
rinsate."
Aventis'
response:
Similar
language
is
already
present
on
Aventis'
SEVIN
®
labels.

EFED
Response:

The
label
language
that
EFED
is
requesting
is
standard
language
that
is
consistent
with
the
risks
identified
for
this
chemical.

Page:
3
EPA
comment:
For
terrestrial
and
residential
uses:
3.
"This
product
may
contaminate
water
through
drift
of
spray
in
wind.
This
product
has
a
high
potential
for
runoff
for
several
days
after
application
after
application
(sic).
Poorly
draining
soils
and
soils
with
shallow
water
tables
are
more
prone
to
produce
runoff
that
contains
this
product.

Household
labels
–
Avoid
applying
this
product
to
ditches,
swales,
and
drainage
ways.
Runoff
of
this
product
will
be
reduced
by
avoiding
applications
when
rainfall
is
forecasted
to
occur
within
48
hours.

Agricultural
Label
–
A
level,
well
maintained
vegetative
buffer
strip
between
areas
to
which
this
product
is
applied
and
surface
water
features
such
as
ponds,
streams,
and
springs
will
reduce
the
potential
for
contamination
of
water
from
rainfall­
runoff.
Runoff
of
this
product
will
be
reduced
by
avoiding
applications
when
rainfall
is
forecasted
to
occur
within
48
hours."
Aventis'
response:
Aventis
would
like
to
further
discuss
appropriate
label
language
with
the
Agency.
However,
it
should
be
noted
that
light
to
moderate
rainfall
(or
irrigation)
after
application
will
also
help
move
carbaryl
residues
deeper
into
the
soil,
thus
making
them
less
susceptible
to
runoff.
The
language
in
the
last
sentence
should
be
changed
to
read,
"…
when
heavy
rainfall
is….".
15
EFED
Response:

EFED
believes
that
it
is
difficult
to
predict
rate
at
which
rain
will
fall
and
that
the
degree
of
runoff
from
or
penetration
into
soil
relative
to
the
amount
of
rainfall
depends
on
the
consistency
of
the
soil.
The
recommended
label
language
is
standard.
This
is
not
an
error.
Further
discussion
on
this
topic
is
more
appropriate
in
a
later
phase
of
the
reregistration
process.

Page:
3
EPA
comment:
For
terrestrial
and
residential
uses:
4.
This
pesticide
is
toxic
to
fish
and
aquatic
invertebrates.
Aventis'
response:
Aventis'
SEVIN
labels
currently
state
"This
product
is
extremely
toxic
to
aquatic
and
estuarine
invertebrates."

EFED
Response:

EFED
has
requested
label
language
to
mitigate
risks
to
both
freshwater
and
estuarine/
marine
fish
and
invertebrates.

Page:
3
EPA
comment:
For
terrestrial
and
residential
uses:
5.
This
product
is
highly
toxic
to
bees
exposed
to
direct
treatment
or
residues
on
blooming
crops
or
weeds.
Do
not
apply
this
product
or
allow
it
to
drift
to
blooming
crops
or
weeds
if
bees
are
visiting
the
treatment
area.
Aventis'
response:
Aventis'
SEVIN
labels
currently
contain
similar
language.

EFED
Response:

The
label
language
that
EFED
has
requested
is
intended
to
emphasize
the
risk
to
bees
when
plants
are
blooming.
16
Draft
RED
Document
1.0
Summary
and
Environmental
Risk
Conclusions
Risk
to
Terrestrial
Organisms
Page:
1
Paragraph:
4
Line:
2
EPA
comment:
As
discussed
in
pp.
44
­
45
and
in
Appendix
D.

Aventis'
response:
The
mammalian
risk
quotients
are
discussed
on
pages
48
to
50
and
in
Appendix
C,
not
as
described
in
this
text.

EFED
Response:

EFED
concurs
with
the
registrant's
comments.
The
references
to
specific
pages
and
to
the
appendix
have
been
deleted.

Fate
and
Water
Assessment
Page:
3
Paragraph:
5
Line:
3
EPA
comment:
…in
the
U.
S.
G.
S
NAQWA
program.
NAQWA…
Aventis'
response:
The
abbreviation
for
the
U.
S.
G.
S.
program
is
NAWQA
EFED
Response:

EFED
concurs
with
the
registrant's
comment
and
has
corrected
the
references
to
NAWQA
acronym
throughout
the
document.

Page:
5
Paragraph:
1
Line:
7
EPA
comment:
…estimate
of
possible
concentrations
drinking
water.

Aventis'
response:
missing
word
–
…concentrations
"in"
drinking…
17
EFED
Response:

EFED
concurs
with
the
registrant's
comment
and
has
included
the
word
"in".

Page:
5
Paragraph:
4
Line:
4
EPA
comment:
…hydrolyzes
in
neutral
(half­
life
=
12
days)
and
alkaline
environments
(pH
9
half­
life
=
3.2).

Aventis'
response:
Missing
units
of
after
second
half­
life.
The
units
are
hours,
so
"=
3.2
hours)".

EFED
Response:

EFED
concurs
with
the
registrant's
comment
and
has
included
the
proper
units,
i.
e.,
hours.

Page:
5
Paragraph:
4
Line:
5
EPA
comment:
…photolysis
in
water
with
a
half­
life
of
21
days
Aventis'
response:
this
is
for
photolysis
in
sterile
water,
not
microbially­
active
water,
so
the
phrase
would
be
more
precise
as
"…
photolysis
in
sterile
water…".

EFED
Response:

EFED
concurs
with
the
registrant's
comment
and
has
changed
the
wording
to
read
"Carbaryl
is
degraded
by
abiotic
photolysis
.
.
.."

Page:
5
Paragraph:
4
Line:
last
EPA
comment:
(Kf
=1.7
to
3.2).
Aventis'
response:
The
upper
value
Kf
for
carbaryl
should
be
listed
as
3.5
as
referenced
by
EPA
elsewhere
(e.
g.
Table
3,
page
20)
in
the
document.

EFED
Response:

EFED
concurs
with
the
registrant's
comment
and
has
changed
the
range
of
Kf
to
read
1.7
–
3.5.
18
2.0
Introduction
Page:
6
Paragraph:
2
Line:
1­
3
EPA
comment:
Carbaryl
(1­
naphthyl
N­
methylcarbamate)
is
a
broad­
spectrum
carbamate
insecticide
and
acaricide
registered
for
control
of
over
300
species
of
insects
and
mites
on
over
100
crop
and
noncrop
use
sites,
including
homeowner
uses;
pet,
poultry,
and
livestock
uses;…
Aventis'
response:
Carbaryl
is
no
longer
registered
for
use
on
livestock.
Aventis
CropScience
will
not
support
the
reregistration
of
the
use
on
poultry
(direct
application
and
poultry
quarters
treatment).
We
will
shortly
submit
a
request
for
cancellation
of
this
use
in
accordance
with
section
6(
f)(
1)
of
the
Federal
Insecticide,
Fungicide
and
Rodenticide
Act
(FIFRA).

EFED
Response:

At
this
time,
carbaryl
is
registered
for
use
on
livestock.
When
the
cancellation
is
processed
the
wording
will
be
changed
for
future
risk
assessments.

Page:
6
Paragraph:
3
Line:
2­
3
EPA
comment:
Approximately
2.5
million
pounds
of
carbaryl
are
applied
annually
in
the
U.
S.
A
map
showing
the
widespread
use
of
carbaryl
in
agriculture
is
shown
in
figure
1.
Aventis'
response:
Summation
of
the
data
in
Figure
1
gives
a
total
of
approximately
3.3
million
pounds
of
carbaryl.
Both
the
2.5
and
3.3
million­
pound
figures
are
inconsistent
with
the
value
of
4
million
pounds
cited
on
page
35.
The
2.5
million
pounds
is
an
average
of
usage
over
1987
to
1996
developed
in
a
memo
by
Frank
Hernandez,
July
21,
1998.
The
value
of
2.5
million
pounds
in
the
text
should
be
qualified
with
the
additional
information
on
the
fact
that
it
is
an
average
for
usage
over
1987
to
1996
and
is
not
a
value
for
a
single
year.

EFED
Response:

EFED
concurs
with
the
registrant's
comments
and
the
text
has
been
revised.

Page:
7
Paragraph:
1
Line:
3­
4
EPA
comment:
Carbaryl
is
also
used
extensively
for
residential
and
other
non­
agricultural
uses,
being
the
second
most
commonly
insecticide
(sic)
used
in
the
home.
19
Aventis'
response:
Carbaryl
is
not
registered
for
use
inside
homes.
It
is
registered
for
use
outdoors
in
the
lawn
and
garden
around
homes.
In
addition,
an
evaluation
of
the
Vista
(Triad)
data
for
the
last
seasonal
year
from
October
1999
to
September
2000
shows
retail
sales
for
carbaryl
at
18.7
million
dollars.
Carbaryl
is
listed
as
number
7
based
on
retail
sales
behind
other
active
ingredients
such
as
chlorpyrifos,
diazinon,
imidacloprid,
hydramethylnon
and
tralomethrin.
Therefore
this
sentence
would
be
more
appropriately
worded
as:
"Carbaryl
is
also
used
for
residential
and
other
non­
agricultural
uses,
being
the
seventh
most
commonly
used
insecticide
around
the
home."

EFED
Response:

EFED
concurs
with
the
registrant's
comments
and
the
text
has
been
revised
to
read
"Carbaryl
is
also
used
for
residential
and
other
non­
agricultural
uses,
being
the
seventh
most
commonly
used
insecticide
around
the
home."

Page:
7
Figure
1
EPA
comment:
Figure
2
Aventis'
response:
This
is
labeled
as
Figure
2
when
it
is
Figure
1
EFED
Response:

EFED
concurs
with
the
registrant's
comments
and
the
figure
showing
carbaryl
use
in
agriculture
has
been
relabeled
as
Figure
1.

3.0
Integrated
Risk
Characterization
Introduction
Page:
8
Paragraph:
1
Line:
last
EPA
comment:
Carbaryl
is
mobile
to
very
mobile
in
the
environment
(Kf
=1.7
to
3.2).
Aventis'
response:
The
upper
value
Kf
for
carbaryl
should
be
listed
as
3.5
as
referenced
by
EPA
elsewhere
(e.
g.
Table
3,
page
20)
in
the
document.
The
classification
of
carbaryl
as
mobile
to
very
mobile
is
inconsistent
with
measured
Koc
values
of
177
to
249.
According
to
the
widely
used
classification
scheme
of
McCall
et
al.
carbaryl
would
be
classified
as
having
medium
mobility
in
soil.
This
classification
of
medium
mobility
is
further
supported
by
the
20
acceptable
column
leaching
study
(MRID
43320701)
in
which
carbaryl
residues
were
only
slightly
mobile
in
a
number
of
soils.

EFED
Response:

There
are
many
classification
systems
available;
EPA
does
not
agree
that
the
McCall
et
al.
classification
is
the
definitive
classification.
For
example,
ASTM
(1996)
puts
Koc
of
177
in
the
medium
mobility
class
approaching
the
high
class.
EFED
has
however
revised
the
chapter
to
read
that
"Carbaryl
is
considered
to
be
moderately
mobile
in
soils."

Aquatic
Organisms
Page:
10,
Paragraph:
1,
Line:
13
EPA
comment:
Submission
of
a
FETOX
amphibian
toxicity
study
is
encouraged.
Aventis'
response:
The
data
requirement
should
be
deleted.
From
the
published
results
it
is
evident
that
carbaryl
is
practically
non­
toxic
to
the
bullfrog.
Effects
in
plain
leopard
frogs
are
reported
at
levels
well
above
environmental
concentrations.
These
results
were
obtained
testing
U.
S.
native
species.
In
the
proposed
FETOX
assay
a
non­
native
species
Xenopus
laevis
is
used.
This
African
species
is
unique
in
its
behavior.
Neither
the
species
nor
the
test
methods
are
suitable
for
ecotoxicological
purposes.
As
the
risk
to
amphibians
can
be
evaluated
from
the
studies
cited,
and
as
the
effects
are
only
at
levels
well
above
the
EEC,
this
study
should
not
be
required.

EFED
Response:

EFED
concurs
that
the
FETOX
assay
may
not
represent
the
most
appropriate
test
for
examining
the
effects
of
carbaryl
on
amphibian
behavior
and
development;
therefore,
EFED
is
not
requiring
the
study
at
this
time.
EFED
is
however
concerned
about
the
effects
of
carbaryl
on
amphibians
and
particularly
the
developmental
effects.
When
appropriate
test
methodologies
have
been
identified
for
examining
endocrine
disrupting
effects,
EFED
will
request
that
carbaryl
undergo
these
toxicity
tests.

Page:
10,
Paragraph:
3,
Line:
6/
7
EPA
comment:
…resulting
in
a
temporary
impairment
of
burying
behavior
and
increasing
exposure
to
predators.

Aventis'
response:
A
reference
for
this
statement
should
be
added.
21
EFED
Response:

EFED
concurs
with
the
registrant's
comments
and
the
appropriate
literature
citation,
i.
e.,
Pozorycki,
1999,
has
been
added.

Page:
11,
Paragraph:
2,
Line:
7
EPA
comment:
In
a
mesocosms
study,
at
carbaryl…
Aventis'
response:
Typographical
error.
Change
to
"In
a
mesocosm
study,
at
carbaryl…"

EFED
Response:

EFED
concurs
with
the
registrant's
comments
and
the
singular
form
of
the
noun
has
been
used.

Terrestrial
Organisms
Page:
12
Paragraph:
2
EPA
comment:
(use
of
rock
dove
LD50
)

Aventis'
response:
The
reference
cited
for
this
value
in
Table
1
of
Appendix
D
is
currently
not
available
to
Aventis.
Table
1
of
Appendix
D
gives
a
range
of
1000
–
3000
mg/
kg
for
the
LD50.
It
should
be
assured
that
1000
is
indeed
the
correct
value.

EFED
Response:

The
reference,
i.
e.,
Hudson,
R.
H.,
R.
K,
Tucker,
and
M.
A.
Haegele.
1984.
Handbook
of
toxicity
of
pesticides
to
wildlife.
U.
S.
Department
of
Interior,
Fish
and
Wildlife
Service
Resource
Publication
153.
Washington
DC,
is
routinely
cited
by
EFED.
The
acute
toxicity
value
(LD50
=1,000
mg/
Kg)
cited
for
rock
dove
represents
the
lower
95%
confidence
interval.
The
text
has
been
revised
to
note
that
this
number
represents
the
lower
95%
confidence
interval.

Page:
12
Paragraph:
3
Line:
3
­
6
EPA
comment:
On
a
chronic
basis,
the
NOAEC
is
300
ppm
for
the
mallard
duck,
based
on
adverse
reproduction
effects,
including
reduced
egg
production,
decreased
fertility,
increase
incidence
of
cracked
eggs,
increased
embryonic
mortality,
and
reduced
hatching
success.
22
Aventis'
response:
The
sentence
should
be
changed.
The
embryonic
mortality
and
the
hatching
success
were
not
different
from
the
control.

EFED
Response:

Although
the
data
evaluation
record
for
the
avian
reproduction
study
lists
increased
embryonic
mortality
and
reduced
hatching
success
as
significant
effects,
reference
to
these
two
effects
has
been
deleted
from
the
text
since
the
original
study
by
Fletcher
was
not
available
for
secondary
review.
However,
reduced
egg
production,
increased
incidence
of
cracked
eggs
and
decreased
fertility
are
reproductive
effects
that
support
EFED's
concerns
regarding
the
endocrine
disrupting
potential
of
carbaryl.

Page:
13
Paragraph:
1
Line:
1
EPA
comment:
…(
rat
LD50
=
307
mg/
kg)
Aventis'
response:
Typographical
error,
the
LD50
is
301
mg/
kg.

EFED
Response:

EFED
concurs
with
the
registrant's
comments
and
the
text
has
been
revised
to
read
"(
rat
LD50
=
301
mg/
L)
.
.
."

Page:
13
Paragraph:
1
Line:
2
–
4
EPA
comment:
…based
on
decreased
fetal
body
weights
and
increased
incomplete
ossification
of
multiple
bones
in
the
laboratory
rat
(LOAEC
=
600
ppm,
NOAEC
=
80
ppm),
has
the
potential
for
mammalian
chronic
effects.

Aventis'
response:
A
new
chronic
reproduction
study
in
rats
has
been
submitted
by
Aventis.
This
study
is
more
relevant
for
an
ecological
risk
assessment
than
the
developmental
study
cited.
The
new
study
resulted
in
a
NOAEC
of
75
ppm.

EFED
Response:

At
the
time
the
ecological
risk
assessment
was
written,
the
more
recent
chronic
mammalian
toxicity
data
were
not
available
for
EFED
to
review.
The
difference
in
NOAEC
would
not
likely
impact
the
magnitude
of
the
chronic
risk
quotient
though.
23
Page:
13
Paragraph:
3
Line:
1
EPA
comment:
Information
available
in
the
open
literature
suggests
potential
reproduction
effects
of
carbaryl
on
mammals.
Aventis'
response:
The
sentence
should
be
changed
or
deleted.
The
literature
cited
in
the
paragraph
show
ambivalent
results.
While
some
references
seem
to
support
that
sentence,
other
references
do
not
substantiate
such
a
claim.
The
potential
for
reproductive
effects
in
mammals
is
evaluated
in
the
recently
submitted
2­
generation
study
in
rats.
No
reproductive
effects
were
seen
in
that
guideline
study.
The
NOAEC
of
75
ppm
was
based
on
pup
mortality.

EFED
Response:

EFED
believes
that
the
chronic
effects
cited,
i.
e.,
reduced
reproduction,
disturbances
in
spermatogenesis,
increased
resorption
of
embryos,
increased
incidence
of
infertility
in
females
and
underdeveloped
testes
in
males,
are
serious
reproductive
effects
that
support
EFED's
concerns
regarding
the
endocrine
disrupting
potential
of
carbaryl.

Page:
13
Paragraph:
4
Line:
5
EPA
comment:
According
to
surveys
conducted
by
the
American
Beekeeping
Federation
and
the
Washington
State
Department
of
Agriculture,
carbaryl
is
one
of
the
pesticides
most
frequently
mentioned
as
being
associated
with
bee
kills.
Aventis'
response:
A
reference
should
be
provided
for
this
statement.

EFED
Response:

EFED
concurs
with
the
registrant's
comments
and
two
literature
citations,
i.
e.,
Brandi
1997
and
Johansen
1997,
have
been
inserted
into
the
text.

Page:
14
Paragraph:
4
Line:
1­
4
EPA
comment:
The
uses
of
carbaryl
on
crops
(corn,
cotton,
soybeans,
sorghum,
wheat,
barley,
oats,
and
rye),
forests
and
pasture/
rangeland
were
addressed
by
the
US
Fish
and
Wildlife
Service
(USFWS)
in
the
reinitiation
of
consultation
in
September
1989.
The
Service
found
jeopardy
to
a
total
of
86
species
–
6
amphibians,
47
freshwater
fish,
27
freshwater
mussels,
and
5
aquatic
crustaceans.
24
Aventis'
response:
The
use
of
carbaryl
on
barley,
oats,
rye,
and
cotton
has
been
cancelled.
It
should
be
noted
that
all
Aventis
CropScience
labels
for
the
technical
materials
and
the
end­
use
products
containing
carbaryl
were
amended
to
delete
these
uses.
The
Agency
has
already
approved
the
labeling
changes.
Findings
from
the
assessment
made
by
the
USFWS
should
be
reevaluated
considering
the
cancellation
of
the
use
on
barley,
oats,
rye,
and
cotton.

EFED
Response:

EFED
does
not
have
the
resources
to
continually
revise
ecological
effects
assessments
each
time
mitigation
efforts
have
been
reached;
however,
the
chapter
has
been
revised
to
read
"
.
.
.
on
field
crops
(corn,
soybeans,
sorghum
wheat)
.
.
.."

Page:
14
Paragraph:
5
Line:
7
EPA
comment:
The
RPAs
and
RPMs
in
the
1989
B.
O.
may
need
to
be
reassessed…
Aventis'
response:
The
acronyms
used
should
be
explained.

EFED
Response:

EFED
concurs
with
the
registrant's
comments
and
the
text
has
been
revised
to
read
"Reasonable
and
Prudent
Alternatives
(RPA)
.
.
.
Reasonable
and
Prudent
Measures
(RPM)
.
.
.."
The
acronym
B.
O.
has
been
replaced
with
the
term
Biological
Opinion.

Endocrine
Disruption
Concerns
Page:
15
Paragraph:
3
EPA
comment:
(Report
on
potential
endocrine
effects)
Aventis'
response:
The
paragraph
should
be
deleted.
As
EPA
pointed
out,
the
findings
reported
in
the
literature
were
made
at
concentrations
well
above
the
highest
peak
concentration
modeled.
Therefore
these
findings
are
irrelevant
for
a
risk
assessment
and
at
the
current
stage
of
discussion
about
endocrine
disruption.
If
the
concern
about
the
endocrine
potential
of
carbaryl
persists,
the
issue
should
be
revisited
once
the
Agency's
endocrine
disrupter
screening
and
testing
program,
as
well
as
a
policy
on
how
to
incorporate
positive
findings
into
an
ecological
risk
assessment
have
been
fully
developed.
25
EFED
Response:

The
ecological
risk
assessment
reports
on
a
broad
range
of
chronic
effects
in
both
terrestrial
and
aquatic
animals
that
support
EFED's
concerns
regarding
the
endocrine
disrupting
potential
of
carbaryl.
EFED
is
aware
of
the
fact
that
its
current
chronic
toxicity
tests
may
not
be
sensitive
indicators
of
endocrine
disrupting
effects,
therefore
the
Agency
has
to
rely
on
open
literature
to
address
this
uncertainty.
EFED
agrees
that
some
effects
are
reported
at
concentrations
that
may
not
be
environmentally
relevant;
however,
the
data
suggest
that
carbaryl
can
elicit
effects
that
are
consistent
with
a
chemical
acting
on
endocrine­
mediated
pathways.
Therefore,
EFED
is
requesting
that
once
appropriate
methodologies
have
been
defined
for
screening
endocrine
disruption
effects,
carbaryl
should
undergo
such
testing.

Page:
15
Paragraph:
4
EPA
comment:
Furthermore,
a
number
of
field
and
laboratory
studies
report
reproduction
effects
with
mammals,
suggesting
that
the
possibility
of
endocrine
disruption
effects
on
wild
mammals
should
be
further
examined.
Aventis'
response:
The
statement
should
be
deleted
or
modified.
As
pointed
out
above,
reports
on
reproductive
effects
of
carbaryl
in
the
open
literature
are
at
least
ambivalent.
The
recently
submitted
2­
generation
study
in
rats
demonstrated
the
absence
of
reproductive
effects.
If
the
general
statement
about
the
potential
for
endocrine
disruption
of
carbaryl
is
maintained,
references
(or
a
cross­
reference
within
the
document)
for
the
above
claim
should
be
provided.

EFED
Response:

As
stated
previously,
chronic
reproductive
tests
have
resulted
in
effects
that
support
EFED's
concerns
regarding
the
endocrine
disrupting
potential
of
carbaryl.
Just
because
one
study
failed
to
show
similar
effects
to
another,
EFED
does
not
believe
that
it
would
be
reasonable
to
discount
the
validity
of
the
earlier
study.
If
anything,
the
data
strongly
suggests
that
additional
data
are
needed
to
better
understand
the
likelihood
of
adverse
effects.
Furthermore,
carbaryl
should
be
subjected
to
tests
specifically
designed
to
address
whether
the
chemical
is
acting
through
endocrinemediated
pathways.

Uncertainties
Page:
15
Paragraph:
Last
Line:
4
EPA
comment:
In
the
absence
of
a
valid
two­
generation
rat
reproduction
study,
mammalian
chronic
RQs
were
based
on
a
rat
prenatal
development
study
NOAEC
(MRID#
44732901).
26
Aventis'
response:
A
new
two­
generation
study
in
rats
was
recently
submitted.

EFED
Response:

As
mentioned
previously,
the
most
recent
two­
generation
reproduction
study
of
rats
was
not
available
for
review
when
the
risk
assessment
was
written;
however,
the
proposed
difference
in
the
NOAEC,
i.
e.,
75
vs
80,
would
not
significantly
impact
the
magnitude
of
the
chronic
mammalian
risk
quotients
nor
would
it
alter
the
fact
that
significant
effects
were
noted
in
the
developmental
study.
However,
the
text
has
been
revised
to
read
"Additionally,
mammalian
chronic
RQs
were
based
on
a
rat
prenatal
development
study
NOAEC
(MRID#
44732901)
rather
than
the
more
traditional
use
of
a
2­
generation
reproduction
study."

4.0
Environmental
Fate
Assessment
Exposure
Characterization
Page:
16
Paragraph:
3
Line:
8
EPA
comment:
Environment
(Kf
=1.7
to
3.2).
Aventis'
response:
The
upper
value
Kf
for
carbaryl
should
be
listed
as
3.5
as
referenced
by
EPA
elsewhere
in
the
document
(e.
g.
Table
3,
page
20).

EFED
Response:

EFED
concurs
with
the
registrant's
comments
and
the
test
has
been
revised
to
read
"Kf
=
1.7
to
3.7".

Page:
16
Paragraph:
3
Line:
last
sentence
EPA
comment:
Detailed
discussion
and
reviews
(DERs)
of
the
studies
that
are
included
in
this
assessment
are
attached
in
Appendix
A.
Aventis'
response:
It
is
inappropriate
to
include
the
DERs
in
the
RED.
A
summary
of
study
findings
is
already
included
in
the
EFED
Chapter.
DERs
should
be
made
available
to
the
public
through
the
regular
procedure
under
the
Freedom
of
Information
Act
after
they
have
been
reviewed
and
cleared
for
confidential
business
information.
27
EFED
Response:

EFED
concurs
with
the
registrant's
comments
that
DERs
should
be
made
available
to
the
public
under
the
Freedom
of
Information
Act
after
they
have
been
reviewed
and
cleared
for
confidential
business
information.

Page:
16
Paragraph:
4
Line:
4
EPA
comment:
lower
levels
(generally
less
than
0.01
µ/
L).
Aventis'
response:
value
missing
units
­
(generally
less
than
0.01
µg/
L).
EFED
Response:

EFED
concurs
with
the
registrant's
comments
and
has
revised
the
text
to
read
"0.01
µg/
L".

Page:
16
Paragraph:
5
Line:
4
EPA
comment:

…monitoring
data
is
of
limited
utility
in
developing
EECs
for
ecological
and
human
health
risk
assessment.
Aventis'
response:
The
drinking
water
monitoring
program
conducted
by
the
registrant
provides
a
real
world
assessment
of
the
potential
for
human
exposure
to
carbaryl
in
drinking
water
derived
from
surface
water.
Drinking
water
concentrations
derived
from
PRZM/
EXAMS
greatly
overestimate
the
potential
exposure
to
carbaryl
in
drinking
water,
generally
by
several
orders
of
magnitude.

EFED
Response:

The
limitations
of
the
monitoring
studies
are
discussed
within
the
chapter
and
provide
sufficient
detail
to
support
EFED's
contention
that
"Because
of
the
limited
amount
of
data
available
and
because
of
potential
problems
with
extant
data
.
.
.
monitoring
data
are
of
limited
utility
in
developing
EECs
for
ecological
and
human
health
risk
assessment."

Page:
17
Paragraph:
1
Line:
2­
3
EPA
comment:
The
maximum
rate
was
taken
from
the
carbaryl
labels.
Aventis'
response:
It
would
be
of
benefit
for
the
Agency
to
be
explicit
and
list
the
carbaryl
labels
that
were
used
to
develop
the
maximum
application
rates
for
the
model
scenarios.
The
reference
cited
in
the
EFED
Chapter
regarding
the
use
of
carbaryl
on
crops
indicates
that
current
labels
were
not
used
for
the
Agency's
assessment.
Many
of
these
crops
have
been
deleted
from
Aventis'
labels
for
a
few
years
Application
28
rates,
number
of
applications
per
season,
and
PHI's
also
have
changed
for
several
crops
on
the
labels.

EFED
Response:

While
EFED
agrees
that
additional
details
are
of
interest
to
some
readers,
it
isn't
possible
to
address
all
potential
interests
concurrently
and
still
have
a
reasonably
sized
document.
As
noted
in
the
chapter
"Average
and
maximum
reported
rates
were
determined
by
BEAD
[Biological
and
Economic
Assessment
Division]
based
on
data
collected
by
Doane
surveys
and
registrant
market
analysis."

Page:
17
Paragraph:
2
Line:
2
EPA
comment:
For
the
Index
Reservoir
scenario
using
maximum
label
rates,
acute
EEC
values
ranged
from
about
10
µg/
L
from
sugar
beets
to
about
500
µg/
L
from
citrus
(Table
6).
Aventis'
response:
Table
6
on
page
33
shows
a
concentration
of
19
µg/
L
for
sugar
beets
treated
with
the
maximum
label
rate
of
2
x
1.5
lb
ai,
not
10
as
stated
in
this
sentence.
A
low
EEC
value
of
9
µg/
L
for
sugar
beets
results
from
the
"maximum
reported"
application
scenario
of
1
x
1.2
lb
ai/
A.

EFED
Response:

EFED
concurs
with
the
registrant's
comments
and
the
text
has
been
revised
to
read
".
.
.
acute
EEC
values
ranged
from
about
19
:g/
L
from
sugar
beets
to
about
500
:g/
L
.
.
.."

Page:
17
Paragraph:
2
Line:
3
EPA
comment:
Chronic
EECs
ranged
from
about
1
to
28
µg/
L.

Aventis'
response:

Table
6
on
page
33
shows
that
this
is
correct
when
considering
all
of
the
model
scenarios.
However,
either
the
same
maximum
label
rate
reference
should
be
used
as
in
the
preceding
sentence
(in
which
case
the
minimum
chronic
EEC
would
be
2),
or
the
basis
for
the
preceding
sentence
should
be
changed
from
the
maximum
label
rate
to
include
all
application
scenarios
to
keep
the
comparisons
consistent.
29
EFED
Response:

EFED
concurs
with
the
registrant's
comments
and
the
text
has
been
revised
to
read
"Chronic
EECs
ranged
from
about
2
to
28
:g/
L."

Page:
17
Paragraph:
2
Line:
8
EPA
comment:
The
results
of
the
modeling
provide
an
(sic)
conservative,
though
not
unreasonable,
estimate
on
(sic)
possible
concentrations
[in]
drinking
water.

Aventis'
response:

It
should
be
clear
that
Aventis'
surface
water
monitoring
program
provides
a
more
reasonable
estimate
of
the
potential
drinking
water
exposure
to
carbaryl
than
the
modeling
numbers,
which
overestimate
exposure
by
several
orders
of
magnitude.

EFED
Response:

The
limitations
of
this
study
are
discussed
in
the
chapter.

Page:
17
Paragraph:
2
Line:
last
EPA
comment:
…and
model
input
and
output
files
are
attached
in
appendix
B.

Aventis'
response:
The
PRZM
input
files
for
only
the
Index
Reservoir
drinking
water
modeling
were
provided
as
an
electronic
copy.
The
PRZM
input
files
for
the
standard
pond
scenarios
were
not
provided
in
the
draft
RED
so
Aventis
could
not
assess
the
data.
None
of
the
output
files
were
provided.

EFED
Response:

EFED
concurs
with
the
registrant's
comments;
a
more
comprehensive
set
of
input
files
have
now
been
included
in
the
chapter
(Appendix
F).

Page:
18
Figure
2
EPA
comment:
Figure
1.
Generalized
carbaryl
degradation
pathway
Aventis'
response:
This
should
be
labeled
Figure
2,
not
Figure
1.
30
EFED
Response:

EFED
concurs
with
the
registrant's
comments
and
the
figure
entitled
Generalized
carbaryl
degradation
pathway
has
been
renumbered
Figure
2
Page:
19
Table
3
EPA
comment:
Hydrolysis
half­
life
at
pH
9
stated
to
be
5
hours.

Aventis'
response:
The
study
results,
and
the
summary
of
the
study
presented
on
page
20,
show
the
correct
halflife
at
pH
9
to
be
3.2
hours.

EFED
Response:

EFED
concurs
with
the
registrant's
comments
and
the
hydrolysis
half­
life
reported
for
pH
in
Table
3
has
been
revised
to
read
3.2
hours.

Page:
19
Table
3
EPA
comment:
Aerobic
Aquatic
half­
life
­
4.9.

Aventis'
response:
The
Aerobic
Aquatic
half­
life
is
4.9
days
EFED
Response:

EFED
concurs
with
the
registrant's
comments
and
the
aerobic
aquatic
metabolism
half­
life
reported
in
Table
3
has
been
revised
to
read
4.9
days.

Page:
19
Table
3
EPA
comment:
Soil
metabolism
T1/
2,
anaerobic,
assumed
stable
31
Aventis'
response:
If
this
guideline
is
satisfied
by
the
data
submitted
for
guideline
162­
3,
it
is
not
clear
why
the
compound
is
assumed
to
be
stable
rather
than
having
a
half­
life
in
line
with
the
72
days
that
resulted
from
the
anaerobic
aquatic
study.
Although
this
parameter
plays
a
fairly
insignificant
role
in
estimating
the
amount
of
carbaryl
available
for
runoff
in
the
models,
it
could
play
a
significant
role
if
one
were
to
use
this
value
in
estimating
leaching
potential
in
subsurface
horizons.

EFED
Response:

EFED
concurs
with
the
registrant's
comments
and
anaerobic
soil
metabolism
half­
life
reported
in
Table
3
has
been
revised
to
read
72
days.
This
does
not
significantly
change
the
model
results.

Page:
20
Table
3
EPA
comment:
Batch
Equilibrium
1/
n
values
ranged
from
0.86­
1.02
Aventis'
response:
These
values
are
for
the
desorption
isotherms
only.
For
the
adsorption
isotherms
that
were
used
to
calculate
the
adsorption
Kf
and
Koc
values
listed
in
the
table,
the
correct
range
of
1/
n
values
are
0.78
to
0.84
as
stated
on
page
22.

EFED
Response:

EFED
concurs
with
the
registrant's
comments
and
the
batch
equilibrium
1/
n
value
range
reported
in
Table
3
has
been
revised
to
read
0.78
to
0.84.

Page:
20
Table
3
EPA
comment:
Foliar
Dissipation
30
days
Willis
and
McDowell,
1987
Aventis'
response:
The
foliar
dissipation
half­
life
listed
by
EFED
is
incorrect.
Table
IV
of
the
Willis
and
McDowell
review
lists
10
foliar
half­
lives
for
various
formulations
of
carbaryl
applied
to
different
crops.
Five
of
these
half­
lives
are
for
a
study
designed
to
evaluate
a
new
analytical
procedure
for
measuring
carbaryl
residues
on
plants.
This
study
was
conducted
on
plants
grown
in
a
greenhouse,
with
some
of
them
receiving
an
unknown
amount
of
simulated
rainfall.
These
studies
on
greenhouse­
grown
plants
should
not
be
used
to
evaluate
foliar
persistence
in
the
field.
The
foliar
persistence
of
pesticides
can
be
considerably
different
for
residues
on
and
in
plants
grown
in
greenhouses
versus
the
field.
Eliminating
the
half­
lives
for
the
greenhouse­
grown
plants
results
in
the
following
half­
lives
for
carbaryl
on
field
32
plants:
Cotton,
1.2,
1.3,
1.5
days;
strawberry,
4.1
days;
tomato
1.4
days.
Therefore,
the
longest
half­
life
of
4.1
days
should
be
listed
in
this
table.

Aventis
intends
to
conduct
a
more
thorough
review
of
the
data
on
the
foliar
dissipation
of
carbaryl
and
prepare
a
more
detailed
response
during
the
60­
day
public
comment
period.

EFED
Response:

EFED
has
reviewed
the
Willis
paper
and
agrees
that
the
foliar
dissipation
rate
for
carbaryl
is
not
well
known
and
may
be
significantly
shorter
then
the
default
value
used.
However,
as
defined
in
EFED
policy,
the
default
value
is
used
when
scientifically
valid,
statistically
robust
data
are
not
available
to
make
a
more
accurate
estimation.
EFED
encourages
development
of
better
data
to
justify
using
a
different
value.

Persistence
Microbially­
Mediated
Processes
Page:
21
Paragraph:
3
Line:
3
EPA
comment:
with
an
initial
concentration
of
11.2
mg/
L,
degraded
with
a
half­
life
of
4.0
days
in
sandy
Aventis'
response:
The
units
for
ppm
soil
concentration
should
be
given
as
mg/
kg.

EFED
Response:

EFED
concurs
with
the
registrant's
comments
and
the
text
has
been
revised
to
read
"11.2
mg/
kg".

Page:
21
Paragraph:
3
Line:
4­
5
EPA
comment:
The
major
degradate
was
1­
naphthol
which
further
degraded
rapidly
to
non­
detectable
levels
within
14
days.

Aventis'
response:
The
data
from
this
study
demonstrate
that
under
aerobic
soil
conditions
the
formation
and
decline
of
1­
naphthol,
starting
from
parent
carbaryl
is
complete
in
less
than
14
days.
The
study
data
show
an
average
maximum
1­
naphthol
level
of
34.5%
of
applied
carbaryl
by
day
1,
declining
to
2.8%
by
day
2,
0%
by
day
4,
0.2%
by
day
7
and
0%
at
day
14.
These
data
suggest
a
preliminary
half­
life
of
less
than
1
day
for
the
major
degradate
1­
naphthol.
33
EFED
Response:

EFED
agrees
that
the
pattern
of
formation
and
decline
suggests
that
1­
naphthol
degrades
rapidly.
However,
from
the
data
it
is
not
possible
to
calculate
a
valid
half­
life
for
1­
naphthol
degradation.
There
are
too
many
processes
(formation
and
degradation,
sorption
and
desorption
for
example)
to
permit
solving
the
multiple
differential
equations
for
the
different
rate
constants.

Page:
21
Paragraph:
3
Line:
8­
9
EPA
comment:
In
anaerobic
aquatic
soil
carbaryl
with
an
about
10
mg/
L
degraded
with
a
half­
life
of
72.2
days.

Aventis'
response:
Several
words
appear
to
be
missing
from
this
sentence.
One
suggestion:
"Carbaryl
degraded
with
a
half­
life
of
72.2
days
in
anaerobic
aquatic
sediment
with
an
initial
carbaryl
concentration
of
about
10
mg/
L."

EFED
Response:

EFED
concurs
with
the
registrant's
comments
and
the
text
has
been
revised
to
read
"Carbaryl
degraded
with
a
half­
life
of
72.2
days
in
anaerobic
aquatic
sediment
with
an
initial
carbaryl
concentration
of
about
10
mg/
L;
1­
naphthol
was
the
major
degradate."

Page:
22
Paragraph
carried
over
from
page
21
Line:
4
on
pg
22
EPA
comment:
Chudhry
and
Wheeler,
1988
Aventis'
response:
This
reference
is
not
included
in
the
reference
list
EFED
Response:

EFED
concurs
with
the
registrant's
comments
and
the
text
has
been
revised
to
read
"Chaudhry
et
al.,
1988.
The
references
section
has
been
revised
to
include
"Chaudhry,
G.
R.,
A.
N.
Ali,
and
W.
B.
Wheeler,
1988.
Isolation
of
a
methyl
parathion_
degrading
Pseudomonas
sp.
that
possesses
DNA
homologous
to
the
opd
gene
from
a
Flavobacterium
sp.
Appl.
Environ.
Microbiol.,
54:
288_
293.

Mobility
Page:
22
Paragraph:
1
Line:
1
EPA
comment:
Carbaryl
is
considered
to
be
mobile
to
very
mobile
in
soils.
34
Aventis'
response:
See
response
directly
below.

EFED
Response:

EFED
concurs
with
the
registrant's
comments
and
the
text
has
been
revised
to
read
"Carbaryl
is
considered
to
be
moderately
mobile
in
soils."

Page:
22
Paragraph:
3
Line:
1­
2
EPA
comment:
Based
on
batch
equilibrium
experiments
(MRID
43259301)
carbaryl
was
determined
to
be
very
mobile
to
mobile
in
soils.

Aventis'
response:
The
classification
of
carbaryl
as
mobile
to
very
mobile
is
inconsistent
with
measured
Koc
values
of
177
to
249.
According
to
the
widely
used
classification
scheme
of
McCall,
et
al.
(1980)
wherein
Koc
values
between
150
and
500
denote
medium
mobility
in
soil,
carbaryl
would
be
classified
as
having
medium
mobility
in
most
soils.
This
classification
of
medium
mobility
is
further
supported
by
the
acceptable
column
leaching
study
(MRID
43320701)
in
which
aged
carbaryl
residues
were
only
slightly
mobile
in
a
number
of
soils.
The
mobility
of
carbaryl
would
be
expected
to
be
higher
in
sandy
soils
or
in
soils
of
low
organic
matter.

EFED
Response:

EFED
concurs
with
the
registrant's
comments
and
the
text
has
been
revised
to
read
"Based
on
batch
equilibrium
experiments
(MRID
43259301)
carbaryl
was
determined
to
be
moderately
mobile
to
mobile
in
soils."

Field
Dissipation
Page:
22
Paragraph:
5
Line:
3
EPA
comment:
The
submitted
field
and
aquatic
dissipation
studies
were
determined
to
be
unacceptable,
and
did
not
provide
useful
information
on
movement
and
dissipation
of
carbaryl
or
its
degradation
products.

Aventis'
response:
The
field
dissipation
study
(MRID
41982605)
submitted
in
1991
demonstrated
that
carbaryl
dissipated
very
rapidly
(t1/
2
<
1
week)
with
no
measurable
leaching.
The
study
included
two
sites,
one
in
North
Carolina
and
one
in
California.
At
the
North
Carolina
site,
~
95%
of
the
Time
0
residues
had
dissipated
by
the
first
sampling
period
7
days
after
application
(the
planned
first
sampling
at
3
days
was
not
collected
due
to
rain).
Similarly,
~
85%
of
the
Time
0
residues
had
dissipated
by
7
days
after
application
at
the
California
site.
Concerning
the
35
movement
of
carbaryl,
samples
were
taken
to
a
depth
of
0.9
meters
in
increments
of
0.15
meters.
No
residues
were
found
below
the
upper
0.15
meters.

EFED
Response:

This
field
dissipation
study
(MRID
41982605)
was
reviewed
and
determined
to
be
scientifically
invalid.
As
described
in
the
text,
these
studies
do
not
provide
reliable
information
on
the
rate
of
dissipation
of
parent
carbaryl
or
formation
of
degradation
products
because
of
inappropriate
sampling
intervals,
poor
sample
storage
stability,
lack
of
degradate
monitoring,
rainfall
and
irrigation
that
were
less
than
evapotranspiration,
and
irrigation
water
with
high
pH.
The
registrant
is
required
to
conduct
additional
studies
and
submit
new
data.
When
the
studies
have
been
reviewed
and
determined
to
be
acceptable,
the
data
will
be
incorporated
into
future
assessments.

Page:
23
Paragraph:
3
Line:
2
EPA
comment:
Because
of
inappropriate
sampling
intervals,
poor
sample
storage
stability,
lack
of
degradate
monitoring,
rainfall
and
irrigation
that
were
less
than
evapotranspiration,
and
irrigation
water
with
high
pH,
these
studies
do
not
provide
reliable
information
on
the
rate
of
dissipation
of
parent
carbaryl
or
formation
of
degradation
products.

Aventis'
response:
The
estimated
half­
life
determined
from
this
study
was
<
3
days.
Sampling
at
intervals
such
that
several
sampling
events
are
taken
prior
to
the
half­
life
of
the
product
is
impractical
for
rapidly
degrading
chemicals
(e.
g.,
those
with
half­
lives
less
than
a
week).
For
this
rapidly
degrading
chemical
an
estimate
of
the
half­
life
should
be
sufficient
for
risk
assessments
even
if
it
is
not
precise.
After
the
report
was
submitted
to
California,
the
freezer
storage
stability
recoveries
at
six
and
nine
months
were
measured
but
not
reported.
Rainfall
plus
irrigation
approximated
an
inch
a
week
and
was
more
than
enough
to
maintain
a
good
soil
moisture
for
agricultural
purposes.
Sulfuric
acid
is
routinely
added
to
irrigation
water
in
the
region
of
California
where
the
field
test
was
conducted
to
neutralize
the
water's
high
pH.
Although
not
stated
in
the
report,
the
irrigation
water
in
the
California
trial
was
treated
in
the
typical
commercial
fashion.
The
acid
is
injected
into
the
irrigation
pipe
as
water
is
pumped
through
it.
Unfortunately,
the
pH
of
the
water
arriving
at
the
field
after
treatment
was
not
measured.

EFED
Response:

As
discussed
in
the
preceding
response,
the
terrestrial
field
dissipation
study
was
reviewed
and
determined
to
be
scientifically
invalid.
The
registrant
is
required
to
conduct
additional
studies
and
submit
new
data.
When
the
studies
have
been
completed
and
reviewed
and
determined
to
be
acceptable
the
data
will
be
incorporated
into
future
assessments.
36
Aquatic
Field
Dissipation
Page:
24
Paragraph:
2
Line:
3
EPA
comment:
They
(do)
not
provide
useable
information
on
the
dissipation
of
carbaryl
and
1­
naphthol
in
aquatic
field
conditions.

Aventis'
response:
The
soil
metabolism
study
referred
to
in
the
report
found
that
the
total
water
soluble
metabolites
did
not
exceed
5%
of
the
total
radioactive
residue,
the
primary
hydrolysis
product,
1­
naphthol,
was
not
found,
and
that
the
only
analyte
of
concern
was
the
parent
insecticide,
carbaryl.
A
soil
metabolism
study
reviewed
concurrently
by
the
Agency
was
issued
later
(MRID
42785101,
classified
"acceptable")
with
similar
results.
Although
the
major
soil
metabolite,
1­
naphthol,
was
found
at
significant
levels
at
day
0
and
day
1,
the
levels
were
less
than
0.7%
by
day
4
and
non­
detectable
by
day
14.
Two
other
metabolites
were
identified
but
never
exceeded
levels
of
1.7%
of
the
total
residue.
Again
the
only
residue
of
concern
was
the
parent
insecticide,
carbaryl.

If
present,
1­
naphthol
would
have
been
detected
by
the
residue
method
used
to
measure
the
residues
of
carbaryl
in
the
soil.

The
estimated
half­
life
determined
from
this
study
was
<
2
days.
Sampling
at
intervals
such
that
several
sampling
events
are
taken
prior
to
the
half­
life
of
the
product
is
impractical
for
rapidly
degrading
chemicals
(e.
g.
those
with
half­
lives
less
than
a
week).

EFED
Response:

The
aquatic
field
dissipation
study
was
reviewed
and
determined
to
be
unacceptable
since
it
did
not
provide
useable
information
on
the
dissipation
of
carbaryl
and
1­
naphthol
under
aquatic
field
conditions.
The
registrant
is
encouraged
to
conduct
additional
studies
and
submit
new
data.
In
future
studies
sampling
intervals
should
be
selected
that
are
appropriate
for
the
expected
half­
life.
When
the
studies
have
been
reviewed
and
determined
to
be
acceptable
the
data
will
be
incorporated
into
future
assessments.
37
Page:
24
Paragraph:
2
Line:
4
EPA
comment:
Frozen
storage
stability
data
were
provided
for
only
6
months,
although
the
water
samples
were
stored
for
up
to
14
months
and
the
soil
samples
were
stored
for
up
to
17.5
months
prior
to
analysis.
The
data
suggest
that
carbaryl
and
1­
naphthol
degraded
significantly
during
storage.
In
the
six
months
of
storage
carbaryl
degraded
an
average
of
34
%
in
Texas
water
and
39%
in
from
Mississippi.
1­
naphthol
degraded
50%
in
water
from
Texas
and
69%
from
Mississippi.
Degradation
did
not
appear
linear,
and
it
is
not
possible
to
extrapolate
out
to
14
months.
It
was
therefore
not
possible
to
evaluate
the
actual
concentrations
of
carbaryl
and
1­
naphthol
in
the
samples
or
estimate
the
dissipation
rates.

Aventis'
response:
The
existing
6­
month
storage
stability
provides
sufficient
information
to
calculate
the
concentrations
of
carbaryl
in
the
samples.
However,
the
metabolite
1­
naphthol
was
shown
to
degrade
significantly
under
the
same
freezer
conditions.
This
instability
simply
confirms
that
1­
naphthol's
presence
in
the
environment
would
be
very
limited
and
should
not
be
of
concern.

EFED
Response:

As
discussed
in
the
preceding
response,
the
aquatic
field
dissipation
study
was
classified
as
unacceptable.
Degradation
did
not
appear
to
be
linear,
and
it
is
not
possible
to
extrapolate
out
to
14
months;
therefore
it
is
not
possible
to
evaluated
the
actual
concentrations
of
carbaryl
and
1­
naphthol
in
the
samples
or
estimate
the
dissipation
rates.

Foliar
Dissipation
Page:
24
Paragraph:
Last
EPA
comment:
The
reported
rates
of
carbaryl
dissipation
from
foliar
surfaces
varies
from
1
days
to
30
days.
In
their
review
of
literature
data
on
pesticide
foliar
persistence,
Willis
and
McDowell
(1987)
report
that
carbaryl
dissipation
rates
varied
from
1.2
to
29.5
days…
For
terrestrial
risk
assessment
modeling
EFED
used
35
days…
Aventis'
response:
As
stated
in
comments
to
Table
3,
the
foliar
dissipation
half­
life
used
by
EFED
for
terrestrial
risk
assessment
is
too
long
and
should
be
corrected.
Table
IV
of
the
Willis
and
McDowell
review
lists
10
foliar
half­
lives
for
various
formulations
of
carbaryl
applied
to
different
crops.
Five
of
these
half­
lives
are
for
a
study
designed
to
evaluate
a
new
analytical
procedure
for
measuring
carbaryl
residues
on
plants.
This
study
was
conducted
on
plants
grown
in
a
greenhouse,
with
some
of
them
receiving
an
unknown
amount
of
simulated
rainfall.
These
studies
on
greenhouse­
grown
plants
should
not
be
used
to
evaluate
foliar
persistence
in
the
field.
The
foliar
persistence
of
pesticides
can
be
considerably
different
for
38
residues
on
and
in
plants
grown
in
greenhouses
versus
the
field.
Eliminating
the
half­
lives
for
the
greenhouse­
grown
plants
results
in
the
following
half­
lives
for
carbaryl
on
field
plants:
Cotton,
1.2,
1.3,
1.5
days;
strawberry,
4.1
days;
tomato
1.4
days.
Therefore,
the
longest
half­
life
of
4.1
days
should
be
used
for
terrestrial
risk
assessment
modeling.

Aventis
will
conduct
a
more
thorough
review
of
the
data
on
the
foliar
dissipation
of
carbaryl
and
prepare
a
more
detailed
response
during
the
60­
day
public
comment
period.

EFED
Response:

EFED
agrees
that
the
dissipation
of
carbaryl
on
foliar
surfaces
is
not
well
understood.
The
registrant
is
encouraged
to
submit
additional
data
on
foliar
dissipation
to
help
clarify
the
rate
and
processes
involved.
Until
scientifically
valid,
statistically
robust
data
are
submitted,
EFED
policy
is
to
use
a
default
value
of
35
days
and
assume
first
order
degradation
kinetics.

Atmospheric
Transport
Page:
25
Paragraph:
1
Line:
2
EPA
comment:
Waite,
et
al.,
1995
Aventis'
response:
This
reference
is
not
included
in
the
reference
list
EFED
Response:

EFED
concurs
with
the
registrant's
comments.
The
reference
section
has
been
revised
to
include
the
following
reference:
Waite,
D.
T.,
R.
Grover,
N.
D.
Westcott,
D.
G.
Irvine,
L.
A.
Kerr
and
H.
Sommerstad,
1995.
Atmospheric
Deposition
of
Pesticides
in
a
Small
Southern
Saskatchewan
Watershed.
Environ.
Toxicol.
and
Chem.,
14:
1171­
1175.

Page:
25
Paragraph:
1
Line:
3
EPA
comment:
Beyer
et
al.,
(1995)
Aventis'
response:
This
reference
is
not
included
in
the
reference
list
EFED
Response:

EFED
concurs
with
the
registrant's
comments.
The
reference
section
has
been
revised
to
include
the
following
reference:
Beyer,
D.
W.,
M.
S.
Farmer
and
P.
J.
Sikoski,
1995.
Effects
of
rangeland
aerial
application
on
Sevin­
4­
Oil
®
on
fish
and
aquatic
invertebrate
drift
in
the
Little
Missouri
River,
North
Dakota.
Arch.
Environ.
Contam.
Toxicol.,
28:
27­
34.
39
Page:
25
Paragraph:
3
Line:
5
EPA
comment:
Schomburg
et
al.
(1991)
Aventis'
response:
This
reference
is
not
included
in
the
reference
list
EFED
Response:

EFED
concurs
with
the
registrant's
comments.
The
reference
section
has
been
revised
to
include
the
following
reference:
Schomburg,
C.
J.,
D.
E.
Glotfelty,
and
J.
N.
Seiber,
1991.
Pesticide
occurrence
and
distribution
in
fog
collected
near
Monetery
California.
Environ.
Sci.
Technol.
25:
155­
160.

1­
Naphthol
Fate
and
Transport
Page:
26
Paragraph:
2
Line:
1­
2
EPA
comment:
In
an
aerobic
soil
metabolism
study
(MRID
42785101),
1­
naphthol
degraded
rapidly
to
nondetectable
levels
within
14
days.
Aventis'
response:
The
data
from
this
study
demonstrate
that
under
aerobic
soil
conditions
the
formation
and
decline
of
1­
naphthol,
starting
from
parent
carbaryl,
is
complete
in
less
than
14
days.
The
study
data
show
an
average
maximum
1­
naphthol
level
of
34.5%
of
applied
carbaryl
by
day
1,
declining
to
2.8%
by
day
2,
0%
by
day
4,
0.2%
by
day
7
and
0%
at
day
14.
These
data
suggest
a
preliminary
half­
life
of
less
than
1
day
for
the
major
degradate
1­
naphthol.
This
half­
life
can
be
used
for
preliminary
environmental
fate
modeling
to
estimate
EECs
for
1­
naphthol.

EFED
Response:

As
stated
previously,
it
is
not
possible
to
separate
the
multiple
processes
occurring
in
this
study,
and
it
is
not
possible
to
calculate
rate
constant
for
degradation
of
1­
naphthol.
Additional
data
on
the
degradation
of
1­
naphthol
are
required.
40
Page:
26
Paragraph:
3
Line:
1
EPA
comment:
No
guideline
information
was
submitted
on
1­
naphthol
sorption.
Literature
information
suggests
that
it
is
not
strongly
sorbed.

Aventis'
response:
The
statement
suggesting
that
1­
naphthol
is
not
strongly
sorbed
to
soil
should
be
deleted.
In
support
of
the
1­
naphthol
sorption
statement
the
Agency
has
cited
only
one
paper
by
Karthikeyan
et
al.
(1999)
that
was
conducted
using
aluminum
hydroxide
as
the
sorbent.
Soil
is
composed
of
much
more
than
aluminum
hydroxide,
so
this
study
is
more
of
a
mechanistic
description
of
sorption
to
this
one
component
of
soil
and
not
a
study
of
sorption
to
soil
as
a
whole.
This
cited
study
reported
that
1­
naphthol
does
not
show
significant
sorption
to
aluminum
hydroxide
when
allowed
to
sorb
for
20
hours
in
the
dark
in
the
absence
of
oxygen.
However,
there
was
a
significant
increase
in
sorption
with
increasing
equilibration
time,
and
as
the
Agency
stated,
the
increase
is
influenced
by
pH,
as
would
be
expected
for
an
acidic
phenolic
compound.

Additional
information
available
in
the
literature
demonstrates
that
the
sorption
of
1­
naphthol
to
soil
is
stronger
than
that
seen
for
carbaryl
itself.
Hassett
et
al.
(1981)
have
demonstrated
that
the
sorption
of
1­
naphthol
was
the
result
of
sorption
to
organic
carbon
resulting
in
an
average
Koc
of
431
±
40
for
10
of
the
16
soil
samples
they
tested.
In
the
remaining
6
soil
samples
the
Koc
was
even
higher
(1,645
to
15,618).
Hassett
et
al.
(reference
submitted
as
part
of
30­
day
response
document)
hypothesized
that
the
higher
Kocs
in
these
6
soils,
in
which
the
organic
carbon
to
clay
ratio
was
very
low,
the
clay
surfaces
were
more
accessible
and
the
sorption
of
1­
naphthol
was
apparently
controlled
by
the
clay
fraction.
In
Burgos
et
al.
(1999),
cited
by
EPA
elsewhere
in
the
RED,
it
was
shown
that
there
is
significant
sorption
of
1­
naphthol
to
two
sandy
soils,
and
that
oxidative
coupling
reactions
were
responsible
for
the
strongly
bound
portion.
In
an
earlier
paper
by
Burgos
et
al.
(1996)
it
was
shown
that
both
biologically­
mediated
and
soil­
catalyzed
oxidative
coupling
lead
to
significant
binding
of
1­
naphthol
residues
to
soil.
These
data
indicate
that
1­
naphthol
is
less
mobile
and
less
susceptible
to
leaching
than
carbaryl
itself,
and
they
demonstrate
that
at
least
a
portion
of
the
1­
naphthol
residue
is
tightly
sorbed
to
soil
constituents.

To
meet
the
requirement
by
the
Agency
for
information
on
the
adsorption
and
desorption
of
1­
naphthol,
the
registrant
is
conducting
an
adsorption/
desorption
study
to
meet
the
163­
1
guideline.
Study
results
should
be
available
for
submission
to
the
Agency
in
the
first
quarter
of
the
calendar
year
2002.

EFED
Response:

Data
from
the
Hassett
paper
have
been
included.
The
text
reads
"Hassett
et
al.
(1981)
reported
an
average
1­
naphthol
Koc
of
431
(±
40)
for
10
of
the
16
soils
tested.
They
also
found
that
in
other
soils
with
very
low
organic
carbon
to
clay
ratios
clay
surfaces
controlled
sorption.
Additional
data
on
41
1­
naphthol
sorption
is
required
to
fully
characterize
mobility."
Additional
data
will
be
reviewed
and
incorporated
into
future
risk
assessments.

Aquatic
Exposure
Assessment
Surface
Water
Page:
26
Paragraph
4
Line
1
EPA
comment:
Five
crop
scenarios:
apples,
field
corn,
sweet
corn,
oranges
and
sweet
potatoes
scenarios
were
use
in
modeling
for
surface
water
EEC.

Aventis'
response:
The
fifth
crop
modeled
was
sugar
beets
(not
sweet
potatoes).

EFED
Response:

EFED
concurs
with
the
registrant's
comments.
The
text
has
been
revised
to
read
"Five
crop
scenarios:
apples,
field
corn,
sweet
corn,
oranges
and
sugar
beets
scenarios
were
used
in
modeling
for
surface
water
EEC."

Page:
27
Table
4
EPA
comment:
Hydrolysis
half­
life
at
pH
9
stated
to
be
5
hours.

Aventis'
response:
The
study
results,
and
the
summary
of
the
study
presented
on
page
20,
show
the
correct
halflife
at
pH
9
to
be
3.2
hours.

EFED
Response:

EFED
concurs
with
the
registrant's
comments.
The
hydrolysis
half­
life
at
pH
9
reported
in
Table
4
has
been
revised
to
read
"3.2
hours".

Page:
27
Table
4
EPA
comment:
(Koc
=
211
for
SCIGROW)
Aventis'
response:
This
is
the
mean
Koc.
According
to
EPA
guidance
the
median
Koc
(209)
should
be
used
for
SCI­
GROW,
although
this
difference
would
not
be
expected
to
affect
the
model
results.
42
EFED
Response:

EFED
concurs
with
the
registrant's
comments.
The
mean
soil
partitioning
coefficient
(Koc)
reported
in
Table
4
now
reads
"(
Koc
=
209
for
SCIGROW)".

Pages:
27­
28
Table
5
EPA
comment:
Tier
II
surface
water
estimated
environmental
concentration
(EEC)
values
derived
from
PRZM/
EXAMS
modeling
for
use
in
ecorisk
assessment
(calculated
using
standard
pond.)

Aventis'
response:
The
PRZM
input
tables
were
not
provided
for
the
standard
pond
scenarios,
so
the
assumption
is
made
that
the
same
application
methods
were
used
for
the
standard
pond
as
for
the
Index
Reservoir
scenarios
that
were
provided
as
an
electronic
copy
of
a
draft
of
Appendix
B.

EFED
Response:

The
registrant's
assumption
is
correct,
i.
e.,
the
same
application
methods
were
used
for
the
standard
pond
as
for
the
Index
Reservoir
scenarios.

Aventis'
comment:

It
would
be
of
benefit
for
the
Agency
to
state
which
of
the
carbaryl
labels
were
used
to
develop
the
"maximum"
label
application
rate
scenarios.
It
would
be
useful
to
add
another
column
to
this
table
to
specify
which
method
of
application
was
used
to
generate
the
EECs
rather
than
the
generic
"air/
ground"
in
column
1.
There
are
a
number
of
errors
in
the
input
parameters
(noted
below)
that
would
lead
to
changes
in
the
calculated
EECs
and
therefore
the
risk
quotients
for
these
uses.

EFED
Response:

EFED
has
reviewed
the
application
rates
used
in
modeling.
The
changes
suggested
by
the
registrant
do
not
result
in
significant
changes
in
the
risk
assessment;
therefore,
the
modeling
was
not
redone.
As
with
most
chemicals,
the
labels
are
in
a
constant
state
of
flux.
Uses
are
dropped
and
rates
varied
constantly.
Also
this
chemical
has
a
large
number
of
labels
making
it
difficult
for
EFED
to
monitor
the
changing
"current"
labels.

The
use
of
average
use
rates
was
to
allow
evaluation
of
EECs
based
on
rates
other
then
the
maximum
allowed.
The
data
that
were
used
to
calculate
"average"
are
not
highly
robust.
It
is
also
not
always
possible
to
use
the
values
in
the
Quantitative
Use
Assessment
(QUA)
as
presented.
For
example
the
average
number
of
applications
for
sugar
beets
was
1.1
per
year.
EFED
selected
rates
and
timing
to
try
to
capture
the
information
in
the
QUA
table.
The
values
should
nor
be
considered
hard,
exact
numbers.
43
If
the
modeling
for
the
"average"
scenarios
were
conducted
using
aerial
applications
for
citrus
and
apples
(as
was
the
case
for
the
Index
Reservoir
scenarios),
then
the
model
results
over­
estimate
the
contributions
from
spray
drift.
Few
applications
to
these
crops
are
made
aerially.
Therefore,
the
model
results
over­
estimate
the
contributions
from
spray
drift
since
the
"average"
applications
to
these
crops
are
made
using
ground
airblast
equipment
with
a
spray
drift
of
6.3%
in
the
model
versus
aerial
applications
with
a
spray
drift
of
16%.

The
"average"
scenario
for
sweet
corn
in
Ohio
should
be
3
applications
at
1.1
lb.
ai/
A/
application
(as
noted
in
the
memo,
"Average
application
rate
from
Quantitative
Usage
Analysis
for
Carbaryl,
prepared
July
21,
1998
by
Frank
Hernandez,
OPP/
BEAD")
and
not
the
2
applications
at
3.4
lb.
ai/
A/
application
as
listed
in
the
table.
It
should
be
noted
that
the
"average"
scenario
presented
in
this
table,
2
applications
per
year
at
3.4
lb.
ai
per
application,
exceed
the
maximum
rate
allowed
on
the
label.

The
maximum
label
rate
application
scenario
for
apples
that
is
allowed
by
the
Sevin
brand
XLR
PLUS
label
(E.
P.
A.
Reg.
No
264­
333),
the
Sevin
brand
80WSP
and
CHIPCO
Sevin
brand
80WSP
labels
(E.
P.
A.
Reg.
No
264­
526)
and
the
CHIPCO
Sevin
brand
SL
label
(E.
P.
A.
Reg.
No
264­
335)
is
5
applications
at
3
lb.
ai/
A/
application
made
every
14
days.
The
scenario
used
in
the
model
applies
less
than
the
maximum
amount
of
product
allowed
by
the
labels.
In
addition,
if
the
same
application
timing
was
used
in
the
modeling
for
the
standard
pond
scenario
as
was
used
in
the
index
reservoir
scenario
(applications
made
by
air
every
4
days)
this
would
be
a
violation
of
the
Aventis
labels
which
restrict
applications
to
a
minimum
of
every
14
days.

The
"average"
scenario
for
sugar
beets
in
Minnesota
should
be
1
application
at
1.3
lb.
ai/
A/
application
(as
noted
in
the
memo,
"Average
application
rate
from
Quantitative
Usage
Analysis
for
Carbaryl,
prepared
July
21,
1998
by
Frank
Hernandez,
OPP/
BEAD")
and
not
1
application
at
1.5
lb.
ai/
A/
application
as
listed
in
the
table.

EFED
Response:

The
Quantitative
Use
Assessment
lists
the
"average"
lb
A.
I./
acre
at
1.5
and
the
average
number
of
applications
as
1.1.

The
"Citrus"
scenario
would
be
more
appropriately
labeled
Oranges.
For
the
average
scenario,
the
3.4
lb.
ai/
A/
application
rate
listed
in
Table
5
is
for
oranges
(as
noted
in
the
memo,
"Average
application
rate
from
Quantitative
Usage
Analysis
for
Carbaryl,
prepared
July
21,
1998
by
Frank
Hernandez,
OPP/
BEAD"),
which
is
the
highest
"average"
application
rate
for
any
type
of
citrus.
Therefore,
this
"average"
scenario
for
oranges
are
at
the
high
end
for
all
citrus
and
overestimates
the
PRZM/
EXAMS
derived
EECs
for
use
in
the
other
citrus
crops.
"Average"
application
rates
for
other
citrus
as
listed
in
the
memo
are:
44
Lemons
–
1.3
applications
at
2.7
lb
ai/
A/
appl
Grapefruit
–
1.6
applications
at
1.4
lb
ai/
A/
appl
Citrus,
other
–
1.8
applications
at
1.8
lb
ai/
A/
appl
The
maximum
label
application
rate
for
citrus
is
7.5
lb
ai
per
application,
not
5
lb
ai,
with
a
maximum
of
20
lb
ai
total
allowed
per
year.
In
California
only,
a
single
application
is
allowed
at
the
rate
of
5
to
16
lb
ai
per
season
for
control
of
California
red
scale
and
yellow
scale.

EFED
Response:

Table
5
has
been
revised
to
read
"oranges"
instead
of
"citrus".

Estimated
Environmental
Concentrations
for
Terrestrial
Ecological
Risk
Assessment
Page:
29
Paragraph:
2
Line:
2­
4
EPA
comment:
In
the
absence
of
reliable
foliar
dissipation
data
a
dissipation
half­
life
of
35
days
is
used.
Published
literature
shows
that
carbaryl
dissipation
rates
vary,
and
are
among
the
highest
observed
for
any
pesticide
(Willis
and
McDowell,
1987).
Aventis'
response:
As
stated
in
more
detail
above,
some
of
the
foliar
dissipation
half­
lives
listed
in
this
reference
are
high
because
they
were
generated
in
the
greenhouse,
not
in
the
field,
and
therefore
they
should
not
be
used.
Eliminating
the
half­
lives
for
the
greenhouse­
grown
plants
results
in
the
following
half­
lives
for
carbaryl
on
field
plants:
Cotton,
1.2,
1.3,
1.5
days;
strawberry,
4.1
days;
tomato
1.4
days.
Therefore,
the
longest
half­
life
of
4.1
days
should
be
used
for
terrestrial
risk
assessment
modeling.

EFED
Response:

As
in
the
response
provided
above,
EFED
agrees
that
the
dissipation
of
carbaryl
on
foliar
surfaces
is
not
well
known.
Until
additional
data
are
provided
the
default
value
is
used.

Page:
29
Paragraph:
2
Line:
6
EPA
comment:
A
more
thorough
description
of
the
model
calculations
and
ELL­
FATE
outputs
are
attached
in
Appendix
B.

Aventis'
response:
No
such
description
or
attachments
were
provided,
so
Aventis
did
not
have
the
opportunity
to
evaluate
the
model.
45
EFED
Response:

EFED
concurs
with
the
registrant's
comments.
A
more
thorough
description
of
the
ELL­
FATE
model
along
with
copies
of
its
input
and
output
files
are
contained
in
Appendix
E.

Page:
29
Paragraph:
2
Line:
last
EPA
comment:
…Tables
4,7,
8
and
9,
Appendix
D.
Aventis'
response:
These
tables
are
in
Appendix
C.

EFED
Response:

EFED
concurs
with
the
registrant's
comments.
The
text
has
been
revised
to
read
"EEC
values
calculated
for
different
crop
applications
are
presented
in
Tables
4,
7,
8,
and
9,
Appendix
C."

5.0
Drinking
Water
Assessment
Water
Resources
Assessment
Page:
29
Paragraph:
3
Line:
3
EPA
comment:
Carbaryl
tends
not
to
partition
to
soil,
aquifer
solids,
or
sediment.
Aventis'
response:
This
sentence
is
misleading
and
should
be
reworded.
Carbaryl
does
partition
onto
these
sorbents,
but
the
sorption
coefficients
are
not
high.
Suggest
rewording
this
such
as:
"Carbaryl
tends
not
to
bind
tightly
to
soil,
aquifer
solids,
or
sediment."

EFED
Response:

EFED
concurs
with
the
registrant's
comments.
The
text
has
been
revised
to
read
"Carbaryl
tends
not
to
bind
tightly
to
soil,
aquifer
solids,
or
sediment."

Page:
29
Paragraph:
4
EPA
comment:
Under
certain
conditions
carbaryl
can
be
expected
to
persist
in
the
environment.
Under
low
pH
conditions
the
compound
is
stable
to
hydrolysis.
In
anaerobic
environments
metabolism
is
fairly
slow
(t½
=
72
days).
This
suggests
that
carbaryl
may
leach
to
ground
water
and
persist
in
some
aquifers.
46
Aventis'
response:
This
last
statement
should
be
removed.
In
contrast
to
this
hypothesis
are
the
data
presented
in
the
NAWQA
and
EPA
databases
that
demonstrate
that
carbaryl
is
not
likely
to
leach
to
ground
water
and
is
not
likely
to
persist
in
aquifers.
The
fact
that
carbaryl
has
been
widely
used
in
agricultural
and
urban
settings
for
more
than
35
years,
and
yet
is
found
at
concentrations
greater
than
0.1
µg
/L
in
only
0.027%
of
the
agricultural
wells,
urban
wells
and
aquifers
sampled
by
NAWQA
(Kolpin,
2001),
indicates
that
this
statement
has
little
merit.
Furthermore,
the
last
sentence
is
in
direct
contradiction
to
the
statement
made
at
the
beginning
of
the
preceding
paragraph
that
carbaryl
"…
has
limited
potential
to
leach
to
ground
water."

EFED
Response:

EFED
concurs
with
the
registrant's
comments.
The
last
sentence
of
the
paragraph
has
been
deleted
and
the
text
reads
"Under
certain
limited
conditions
carbaryl
may
be
expected
to
persist
in
the
environment.
Under
low
pH
conditions
the
compound
is
stable
to
hydrolysis.
In
anaerobic
environments
metabolism
is
fairly
slow
(t½
=
72
days)."

Page:
30
Paragraph:
1
Lines
1­
3
EPA
comment:
Surface
water
monitoring
studies
show
that
carbaryl
is
the
second
most
widely
detected
insecticide
after
diazinon.
Carbaryl,
at
typically
low
concentrations,
is
found
in
greater
than
20
%
of
surface
samples
at
concentrations
up
to
7
ppb.

Aventis'
response:
These
summary
statements
are
based
on
the
NAWQA
database,
with
the
exception
of
the
7
ppb
concentration.
The
highest
reported
value
in
the
NAWQA
database
is
5.5
ppb.
The
value
of
7
ppb
does
not
come
from
the
NAWQA
database
but
from
the
report
by
Werner
et
al.
(2000).
In
fact,
a
maximum
carbaryl
concentration
of
8.4
ppb
was
reported
for
surface
water
samples
in
the
California
DPR
surface
water
database
(see
discussion
section).
The
sources
of
the
information
should
not
be
mixed,
or
the
source
of
the
information
should
be
explicitly
stated.

EFED
Response:

EFED
concurs
with
the
registrant's
comments.
The
text
has
been
revised
to
read
"Surface
water
monitoring
studies
show
that
carbaryl
is
the
second
most
widely
detected
insecticide
after
diazinon.
Carbaryl,
at
typically
low
concentrations,
is
found
in
greater
than
20
%
of
surface
samples
in
NAWQA
studies
at
concentrations
up
to
5.5
ppb.
Carbaryl
is
detected
more
frequently
in
nonagricultural
areas
(about
40%)
then
in
agricultural
areas
(about
5
%).
A
maximum
carbaryl
concentration
of
8.4
ppb
was
reported
for
surface
water
samples
in
the
California
DPR
surface
water
database.
Carbaryl
is
generally
not
widely
detected
in
groundwater
monitoring
studies
though
some
studies
have
found
concentrations
of
up
to
several
hundred
ppb.
Concentrations
as
high
as
610
:
g/
L
have
been
detected
in
one
case
but
typical
groundwater
concentrations
are
much
lower.
NAWQA
47
studies
have
found
that
about
1
%
of
groundwater
samples
have
measurable
levels
(>
0.003
:
g/
L)
of
carbaryl,
with
a
maximum
concentration
of
0.02
:
g/
L.
Targeted
studies
designed
to
measure
carbaryl
in
groundwater
are
not
available."

Drinking
Water
Exposure
Assessment
Page:
30
Paragraph:
2
Line:
3­
4
EPA
comment:
Carbaryl
is
the
second
most
commonly
detected
insecticide
in
surface
water,
and
can
be
expected
to
contaminate
drinking
water
derived
from
surface
water
bodies.

Aventis'
response:
The
surface
water­
monitoring
program
conducted
by
Aventis
shows
an
insignificant
impact
of
carbaryl
on
drinking
water.

EFED
Response:

EFED's
interpretation
of
the
surface
water­
monitoring
program
conducted
by
Aventis
has
been
discussed
previously
in
this
document.

Page:
30
Paragraph:
2
Line:
7
EPA
comment:
The
maximum
reported
value
was
7.0
µg
/L.

Aventis'
response:
The
maximum
value
reported
in
the
NAWQA
database
is
5.5
µg
/L.
The
only
carbaryl
detection
reported
in
the
study
by
Werner
et
al.
(2000)
was
7.0
µg
/L.
The
maximum
value
reported
in
the
California
DPR
Surface
Water
database
is
8.4
µg/
L.
Since
all
of
the
statistics
made
in
this
paragraph
refer
to
the
NAWQA
data,
the
reference
to
the
maximum
reported
concentration
should
be
5.5
µg
/L.

EFED
Response:

EFED
concurs
with
the
registrant's
comments.
The
text
has
been
revised
to
read
"The
maximum
reported
value
in
surface
water
was
8.4
µg/
L."

Page:
30
Paragraph:
4
Line:
2
EPA
comment:
Older
studies
using
GC
or
GC/
MS
generally
have
poor
recovery
and
quantitation
limits.
Because
of
this
difficulty
in
analysis
the
actual
concentration
of
carbaryl
in
groundwater
and
surface
waters
may
be
higher
than
reported.
48
Aventis'
response:
The
basis
for
making
this
generalization
is
not
readily
apparent
and
these
statements
should
be
removed.
Comments
regarding
the
recovery
reported
for
the
GC/
MS
method
used
in
the
NAWQA
survey
are
made
below
in
reference
to
statements
made
on
page
34
paragraph
5,
and
are
elucidated
in
the
discussion
section
at
the
end
of
this
response
document.
The
method
detection
limit
(MDL)
reported
for
the
GC/
MS
method
used
for
the
NAWQA
program
is
0.003
ppb
(Zaugg
et
al.,
1995;
Larson
et
al.
,
1999).
The
limit
of
detection
for
the
HPLC/
MS/
MS
method
used
in
the
carbaryl
surface
water
monitoring
study
being
conducted
by
the
registrant
(LOD,
0.002
ppb;
LOQ
0.030
ppb)
is
similar
to
the
GC/
MS
method
used
for
the
NAWQA
program.
In
addition
to
the
GC/
MS
method
used
in
the
NAWQA
program,
carbaryl
was
also
analyzed
by
HPLC/
photodiode­
array
detection
in
a
limited
number
of
samples
with
a
MDL
of
0.008
(Werner
et
al.,
1996).
Therefore,
the
quantification
limits
reported
for
the
GC/
MS
method
used
to
generate
a
majority
of
the
carbaryl
data
in
the
NAWQA
database
is
very
similar
to
the
quantification
limits
for
available
HPLC
methods.
See
the
discussion
section
at
the
end
of
this
response
document
for
a
summary
of
the
available
NAWQA
data
obtained
by
the
GC/
MS
and
HPLC/
PDA
methods.

EFED
Response:

EFED
has
concerns
that
poor
detection
limits
in
the
past
may
have
underestimated
the
concentration
of
carbaryl
in
surface
and
groundwater.
However,
a
sentence
has
been
added
to
the
paragraph
stating
"More
recent
studies
using
HPLC/
MS
should
provide
better
data
on
the
true
extent
and
magnitude
of
water
contamination
from
the
use
of
carbaryl."

Page:
30
Paragraph:
4
Line:
4
EPA
comment:
More
recent
studies
using
HPLC/
MS
should
provide
better
data
on
the
true
extent
and
magnitude
of
water
contamination
from
the
use
of
carbaryl.

Aventis'
response:
Aventis
believes
that
our
ongoing
targeted
surface
water­
monitoring
program
using
HPLC/
MS/
MS
accurately
reflects
the
extent
and
magnitude
of
carbaryl
exposure
in
drinking
water
derived
from
surface
water.

EFED
Response:

EFED
agrees
that
the
ongoing
study
applies
more
appropriate
analytical
methods.
The
limitations
of
the
study
have
been
discussed
elsewhere.
49
Drinking
Water
Modeling
Page:
31
Paragraph:
carried
over
from
page
30
Line:
8
EPA
comment:
A
partial
list
of
input
parameters
for
the
PRZM/
EXAMS
modeling
are
given
in
Table
4.

Aventis'
response:
The
partial
list
of
input
parameters
in
Table
4
includes
multiple
conservative
assumptions
likely
to
lead
to
significant
over­
estimation
of
the
potential
surface
water
concentrations
of
carbaryl.

EFED
Response:

The
modeling
was
done
following
EFED
policy
and
standard
procedures.
EFED
concurs
with
the
registrant
that
the
PRZM/
EXAMS
model
includes
a
number
of
conservative
assumptions.

Page:
31
Paragraph:
2
Line:
1
EPA
comment:
For
the
Index
Reservoir
scenario
using
maximum
label
rates,
acute
EEC
values
ranged
from
19
µg/
L
from
sugar
beets
to
494
µg/
L
for
oranges
(Table
6).

Aventis'
response:
Table
6
on
page
33
shows
a
concentration
of
19
µg/
L
for
sugar
beets
treated
with
the
maximum
label
rate
of
2
x
1.5
lb
ai,
not
10
as
stated
in
this
sentence.
A
low
EEC
value
of
9
µg/
L
for
sugar
beets
results
from
the
"maximum
reported"
application
scenario
of
1
x
1.2
lb
ai/
A.

EFED
Response:

EFED
concurs
with
the
registrant's
comment.
The
text
had
been
revised
to
present
more
generalized
ranges
and
reads
".
.
.
acute
EEC
values
ranged
from
about
10
µg/
L
from
sugar
beets
to
about
500
µg/
L
from
citrus
(Table
6)."

Page:
31
Paragraph:
2
Line:
3
EPA
comment:
Chronic
EECs
ranged
from
about
1
to
28
µg/
L.
50
Aventis'
response:
Table
6
on
page
33
shows
that
this
is
correct
when
considering
all
of
the
model
scenarios.
However,
either
the
same
maximum
label
rate
reference
should
be
used
as
in
the
preceding
sentence
(in
which
case
the
minimum
chronic
EEC
would
be
2),
or
the
basis
for
the
preceding
sentence
should
be
changed
from
the
maximum
label
rate
to
include
all
application
scenarios
to
keep
the
comparisons
consistent.

EFED
Response:

EFED
concurs
with
the
registrant's
comments.
The
text
has
been
revised
and
now
reads
"Chronic
EECs
ranged
from
about
2
to
28
µg/
L."

Page:
31
Paragraph:
2
Line:
6
EPA
comment:
It
is
highly
unlikely
that
any
but
the
most
extensive
targeted
monitoring
would
capture
the
actual
peak
concentrations.

Aventis'
response:
The
role
of
a
peak
concentration
in
dietary
exposure
assessment
is
undergoing
reexamination
within
EPA.
The
current
policy
of
EPA
appears
to
define
a
certain
percentile
as
an
appropriate
value
for
use
in
screening
assessments,
but
the
exact
percentile
to
be
used
is
being
currently
set
by
EPA
management.
(The
most
recent
documents
from
EPA
cite
the
95
th
or
99
th
percentile.)
For
more
comprehensive
assessments,
a
distribution
of
values
is
preferred.

EFED
Response:

EFED
further
qualifies
its
statement
by
saying
"The
results
of
the
modeling
provide
a
very
conservative,
though
not
unreasonable,
estimate
of
possible
concentrations
in
drinking
water.
A
more
detailed
assessment
of
the
source
of
water
used
to
provide
drinking
water
and
the
relationship
between
the
areas
where
carbaryl
is
used
and
surface
water
sources
is
required
to
more
accurately
evaluate
possible
human
exposures."

Page:
31
Paragraph:
2
Line:
7
EPA
comment:
The
results
of
the
modeling
provide
a
conservative,
though
not
unreasonable,
estimate
on
possible
concentrations
drinking
water.(
sic)

Aventis'
response:
The
modeling,
performed
according
to
EPA
procedures,
provides
an
upper
bound
estimate
on
potential
concentrations
in
drinking
water
from
surface
water.
Whether
the
modeling
estimates
are
reasonable
depends
on
the
specific
assumptions.
For
carbaryl,
the
three­
year
monitoring
program
(conducted
according
to
EPA
and
ILSI
guidance
available
at
the
time
51
the
study
was
started)
shows
that
the
model
calculations
are
unreasonable.
These
conservative
assumptions
include
a
3x
factor
on
both
the
aerobic
soil
and
aerobic
aquatic
half
lives,
assuming
the
maximum
drift
rate
for
aerial
applications
throughout
the
county
(in
Florida
citrus
almost
all
applications
are
by
air
blast
with
ground
equipment),
and
the
application
rate
over
a
watershed.
The
conservative
nature
of
the
application
assumption
alone
probably
results
in
an
overprediction
by
at
least
two
orders
of
magnitude.
The
modeling
calculations
assume
an
application
rate
of
17.4
lbs/
acre
of
watershed
annually.
In
Hardee
County,
the
county
with
the
highest
usage
of
carbaryl,
the
average
use
rate
on
a
countywide
basis
is
only
0.31
lb/
acre
(See
Appendix
II).
In
Manatee
County,
the
county
with
the
highest
usage
containing
a
watershed
used
to
supply
drinking
water,
the
average
rate
on
a
countywide
basis
is
0.027
lb/
acre.

EFED
Response:

EFED
concurs
with
the
registrant's
comments
and
as
noted
in
the
previous
response,
the
text
has
been
revised
and
now
reads
"The
results
of
the
modeling
provide
a
[very]
conservative,
though
not
unreasonable,
estimate
of
possible
concentrations
[in]
drinking
water."

Page:
31
Paragraph:
2
Line:
8
EPA
comment:
A
more
detailed
assessment
of
the
source
of
water
used
to
provide
drinking
water
and
the
relationship
between
the
areas
where
carbaryl
is
used
and
surface
water
sources
is
required
to
more
accurately
evaluate
possible
human
exposures.

Aventis'
response:
As
mentioned
by
EPA
in
this
document,
ground
water
is
the
source
of
the
majority
of
Florida
drinking
water.
Many
of
the
counties
with
the
highest
use
of
carbaryl
contain
no
watersheds
used
to
provide
drinking
water.
As
discussed
more
fully
in
Appendix
I,
the
watershed
supplying
the
Manatee
County
Water
Treatment
Plant
appears
to
have
the
most
carbaryl
usage
of
drinking
water
watersheds
in
Florida.

EFED
Response:

The
registrant's
response
is
expressing
their
perspective
on
the
likelihood
that
watersheds
in
particular
areas
serve
as
drinking
water
sources;
the
comments
do
not
reflect
an
error
in
the
EFED
risk
assessment.
52
Water
Treatment
Effects
Page:
31
Paragraph:
3
Line:
8
EPA
comment:
Since
relatively
(sic)
few
water
treatment
facilities
in
the
U.
S.
use
ozone
the
limited
data
available
do
not
indicate
that
carbaryl
is
likely
to
be
degraded
in
the
majority
of
treatment
plants.
Aventis'
response:
The
monitoring
program
conducted
by
the
registrant
shows
that
removal
occurs
in
some
treatment
plants.
The
effect
of
treatment
seemed
to
be
greater
in
systems
using
carbon
treatment.

EFED
Response:

The
design
of
the
water
monitoring
study
does
not
allow
the
results
to
be
used
to
evaluate
treatment.
For
example,
raw
and
treated
water
samples
were
not
collected
from
the
same
mass
of
water,
and
treated
water
was
not
analyzed
for
all
sampling
periods.
Treated
water
was
found
to
have
higher
concentration
in
at
least
one
case.
The
limitations
of
the
study
have
been
discussed
elsewhere.

Page:
33
Table
6
EPA
comment:
Drinking
Water
EECs
(Table
6
entitled)
Aventis'
response:
Many
of
the
comments
for
this
table
are
similar
to
those
for
the
EECs
for
ecological
risk
found
in
Table
5.

The
PRZM
model
input
parameters
for
the
Index
Reservoir
scenarios
were
received
as
an
electronic
copy
of
a
draft
of
Appendix
B.
These
input
files
are
very
useful
for
assessing
the
scenarios
that
have
been
modeled.

It
would
be
useful
to
add
another
column
to
Table
6
to
specify
which
method
of
application
was
used
to
generate
the
EECs
(and
thus
the
application
efficiency
and
spray
drift
values).
It
would
be
of
benefit
for
the
Agency
to
state
which
of
the
carbaryl
labels
were
used
to
develop
the
"maximum"
label
application
rate
scenarios.
There
are
a
number
of
errors
in
the
input
parameters
(noted
below)
that
would
lead
to
changes
in
the
calculated
EECs
and
therefore
the
risk
quotients
for
these
uses.

The
model
parameters
listed
in
the
electronic
draft
of
Appendix
B
show
that
the
"average"
scenarios
for
citrus
and
apples
were
conducted
using
aerial
applications.
Few
applications
to
these
crops
are
made
aerially.
Therefore,
the
model
results
over­
estimate
the
contributions
from
spray
drift
since
the
"average"
applications
to
these
crops
are
made
using
ground
airblast
equipment
with
a
spray
drift
of
6.3%
versus
aerial
applications
with
a
spray
drift
of
16%.
53
The
"maximum
label
rate"
application
scenario
for
apples
that
is
allowed
by
the
Sevin
brand
XLR
PLUS
label
(E.
P.
A.
Reg.
No
264­
333),
the
Sevin
brand
80WSP
and
CHIPCO
Sevin
brand
80WSP
labels
(E.
P.
A.
Reg.
No
264­
526)
and
the
CHIPCO
Sevin
brand
SL
label
(E.
P.
A.
Reg.
No
264­
335)
is
5
applications
at
3
lb
ai/
A/
application
made
every
14
days.
The
scenario
used
in
the
model
applies
less
than
the
maximum
amount
of
product
allowed
by
the
labels.
In
addition,
application
timing
was
used
in
the
modeling
for
the
index
reservoir
scenario
(applications
made
by
air
every
4
days)
that
would
be
a
violation
of
the
Aventis
labels
which
restrict
applications
to
a
minimum
of
every
14
days.

The
"average"
scenario
for
sweet
corn
in
Ohio
should
be
3
applications
at
1.1
lb
ai/
A/
application
(as
noted
in
the
memo,
"Average
application
rate
from
Quantitative
Usage
Analysis
for
Carbaryl,
prepared
July
21,
1998
by
Frank
Hernandez,
OPP/
BEAD")
and
not
the
2
applications
at
3.4
lb
ai/
A/
application
as
listed
in
the
table.
The
PRZM
input
file
shows
the
correct
inputs
of
3
applications
at
1.1
lb
ai/
A/
application.

The
"average"
scenario
for
sugar
beets
in
Minnesota
should
be
1
application
at
1.3
lb
ai/
A/
application
(as
noted
in
the
memo,
"Average
application
rate
from
Quantitative
Usage
Analysis
for
Carbaryl,
prepared
July
21,
1998
by
Frank
Hernandez,
OPP/
BEAD")
and
not
1
application
at
1.5
lb
ai/
A/
application
as
listed
in
the
table
and
the
PRZM
input
file.

The
"Citrus"
scenario
would
be
more
appropriately
labeled
Oranges.
For
the
average
scenario,
the
3.4
lb
ai/
A/
application
rate
listed
in
Table
5
is
for
oranges
(as
noted
in
the
memo,
"Average
application
rate
from
Quantitative
Usage
Analysis
for
Carbaryl,
prepared
July
21,
1998
by
Frank
Hernandez,
OPP/
BEAD"),
which
is
the
highest
"average"
application
rate
for
any
type
of
citrus.
Therefore,
this
"average"
scenario
for
oranges
is
at
the
high
end
for
all
citrus
and
overestimates
the
EECs
for
use
in
the
other
citrus
crops.
"Average"
application
rates
for
other
citrus
as
listed
in
the
memo
are:
Lemons
–
1.3
applications
at
2.7
lb
ai/
A/
appl
Grapefruit
–
1.6
applications
at
1.4
lb
ai/
A/
appl
Citrus,
other
–
1.8
applications
at
1.8
lb
ai/
A/
appl
EFED
Response:

EFED
used
available
data
from
the
Biological
and
Economic
Assessment
Division
(BEAD)
in
2001
to
develop
the
risk
assessment.
However,
the
recommended
changes
would
not
substantially
change
EFED's
risk
assessment;
therefore,
the
table
has
not
been
significantly
revised
other
than
changing
"citrus"
to
read
"oranges".

Ground
Water
Resources
Page:
34
Paragraph:
carried
over
from
page
33
Line:
3
EPA
comment:
U.
S.
EPA.
Pesticides
in
Groundwater
Database
(Jacoby
et
al.,
1992)
54
Aventis'
response:
This
reference
is
not
provided
in
the
reference
list.

EFED
Response:

EFED
concurs
with
the
registrant's
comments
and
the
reference
section
has
been
revised
to
include
the
following
reference:
Jacoby,
H.,
C.
Hoheisel,
J.
Karrie,
S.
Lees,
L.
Davies­
Hilliard,
P.
Hannon,
R.
Bingham,
E.
Behl,,
D.
Wells,
and
E.
Waldman,
1992.
Pesticides
in
groundwater
database:
a
compilation
of
monitoring
studies:
1971­
1991
National
Summary.
EPA
734­
12­
92­
001.

Page:
34
Paragraph:
3
Line:
3
EPA
comment:
Detections
were
from
(sic)
mainly
from
three
use
sites:
wheat
(5.8
%
of
well
samples
from
wheat
land
use),
orchards
and
vineyards
(1.7
%
of
well
samples
from
orchard
and
vineyard
land
use),
and
urban
(1.8%
of
urban
groundwater
samples).

Aventis'
response:
Updated
information
(noted
below)
is
not
summarized
in
the
same
manner
as
in
this
statement,
so
direct
comparisons
cannot
be
made
easily.
However,
the
updated
information
indicates
a
similar
pattern
of
low
concentrations
of
carbaryl
detections
in
a
limited
number
of
ground
water
resources.

EFED
Response:

EFED
concurs
with
the
registrant's
comments
and
the
text
has
been
revised
to
read
"Detections
were
mainly
from
three
use
sites:
wheat
(5.8
%
of
well
samples
from
wheat
land
use
),
orchards
and
vineyards
(1.7
%
of
well
samples
from
orchard
and
vineyard
land
use),
and
urban
(1.8%
of
urban
groundwater
samples).
Data
on
pesticides
in
groundwater
were
reviewed
by
Kolpin
et
al.
(1998)
and
updated
information
is
available
at:
http://
water.
wr.
usgs.
gov/
pnsp/
pestgw/."

Page:
34
Paragraph:
3
Line:
6
EPA
comment:
Limitations
in
analytical
methodology
(described
elsewhere)
apply
to
groundwater
sample
analysis
also
suggesting
that
there
(sic)
actual
maximum
concentrations
and
extent
of
contamination
may
be
significantly
higher.
Aventis'
response:
This
statement
is
misleading
and
should
be
deleted.
The
validation
of
the
most
widely
used
GC/
MS
method
for
the
data
contained
in
NAWQA
show
recoveries
of
86
to
94%
at
spiking
levels
of
0.1
to
1.0
µg/
L
with
an
MDL
of
0.003
µg/
L.
The
HPLC
method
validation
reported
recoveries
of
58
to
64%
%
at
spiking
levels
of
0.1
to
1.0
µg/
L
with
an
MDL
of
0.018
µg/
L.
Furthermore,
using
the
GC/
MS
method,
a
mean
recovery
of
115%
was
found
for
field
matrix
55
spikes
of
carbaryl
at
spiking
levels
of
0.1
µg/
L.
With
the
GC/
MS
method
MDL
of
0.003
µg/
L
and
a
mean
recovery
of
115%
for
the
field
matrix
spikes,
this
method
cannot
reasonably
be
characterized
as
stated
by
EPA.
Additional
details
of
the
method
validations
and
field
matrix
spikes
are
provided
in
the
`Discussion
Section'
at
the
end
of
this
response.

EFED
Response:

EFED
has
revised
the
text
to
read
"Because
of
limitation
in
the
analytical
methods
used
there
is
some
uncertainty
in
the
quantitative
accuracy
of
carbaryl
analysis."

Page:
34
Paragraph:
3
Line:
last
EPA
comment:
…and
updated
information
is
available
at:
.

Aventis'
response:
This
web
page
was
last
updated
in
1998.
A
more
recent
update
by
Kolpin
was
posted
June
11,
2001
at:
http://
water.
wr.
usgs.
gov/
pnsp/
pestgw/
and
is
the
source
of
the
updated
information
included
in
the
`Discussion
Section'
at
the
end
of
this
response.

EFED
Response:

EFED
concurs
with
the
registrant's
comment
and
the
website
has
been
updated
to
read
"
http://
water.
wr.
usgs.
gov/
pnsp/
pestgw/".

Surface
Water
Resources
Monitoring
Data
Page:
34
Paragraph:
4
Line:
5­
6
EPA
comment:
Because
of
limitation
in
the
analytical
methods
used
there
is
some
question
as
to
the
accuracy
of
carbaryl
analysis.

Aventis'
response:
This
generalized
statement
needs
to
be
qualified
or
deleted.
Whereas
the
authors
of
reports
written
as
part
of
the
NAWQA
program
have
been
clear
about
the
potential
limitations
of
the
quantitative
nature
of
the
carbaryl
data
in
the
database,
they
have
also
been
clear
about
the
validity
of
the
qualitative
nature
of
the
data.
The
use
of
the
multi­
residue
method
in
the
NAWQA
program
does
have
some
limitations
as
a
result
of
the
large
numbers
of
diverse
pesticides
and
degradation
products
that
they
are
monitoring.
However,
the
QC/
QA
data
generated
as
part
of
the
NAWQA
program
(described
in
the
discussion
section
on
surface
56
water
at
the
end
of
this
response)
demonstrate
the
validity
of
the
detections
of
carbaryl
in
the
studies.
The
monitoring
study
conducted
by
the
registrant,
and
reported
in
this
section,
does
not
have
the
same
potential
limitations
in
the
analytical
method
since
the
method
is
looking
specifically
for
carbaryl.
Therefore,
the
analytical
method
used
by
the
registrant
does
not
raise
questions
about
the
accuracy
of
the
carbaryl
analysis.

EFED
Response:

EFED
concurs
with
the
registrant's
comment
and
the
text
has
been
revised
to
read
"Because
of
limitations
in
the
analytical
methods
used
there
is
some
uncertainty
in
the
quantitative
accuracy
of
carbaryl
analysis."

Page:
34
Paragraph:
4
Line:
5­
6
EPA
comment:
Poor
analytical
methods
probably
have
resulted
in
lower
detection
rates
and
lower
concentrations
than
actually
present.

Aventis'
response:
This
generalized
statement
should
be
deleted
for
reasons
provided
above
and
in
the
discussion
section.

NAQWA
(sic)

EFED
Response:

EFED
concurs
with
the
registrant's
comments
and
the
sentence
has
been
deleted.
Additionally,
all
references
to
the
National
Water
Quality
Assessment
(NAWQA)
acronym
have
been
corrected.

Page:
34
­
35
Paragraph:
5
Lines:
5­
8
EPA
comment:
Carbaryl
analytical
results
are
fairly
poor,
with
a
typical
mean
percent
recovery
of
24%
(
F
=
15)
in
laboratory
quality
control
samples,
and
a
method
detection
limit
(MDL)
of
0.003
ug/
L.
This
suggests
that
the
values
reported
do
not
represent
the
maximum
concentrations
that
exist,
and
that
surface
water
contamination
may
be
more
widespread
than
the
data
show.

Aventis'
response:
These
statements
are
misleading
and
should
be
updated
with
further
quality
control
data
supplied
by
NAWQA.
57
A
discussion
of
the
analytical
method
used
in
the
NAWQA
program
is
presented
in
the
USGS
Open­
File
Report
95­
181
(see
Zaugg
et
al.
(1995)
in
references).
The
mean
percent
recovery
of
24%
noted
above
can
be
found
in
Table
9
of
this
report
and
is
by
no
means
"typical".
A
mean
recovery
value
of
24%
was
reported
for
reagent­
grade
water
fortified
at
a
level
of
0.03
:
g/
L
with
a
method
detection
limit
said
to
be
0.003
:
g/
L.
Additional
recoveries
for
fortified
water
samples
(reagent­
grade,
ground
and
surface
waters)
ranged
from
10
to
202%
(see
discussion
section).
The
carbaryl
data
in
thenot
because
the
carbaryl
concentrations
are
underestimated.

Additional
evaluations
of
field
blank,
field
matrix
spike
and
lab
control
spike
samples
as
part
of
the
NAWQA
program
can
be
found
in
a
provisional
report
by
Martin
(1999).
This
report
demonstrates
the
lack
of
detection
of
carbaryl
in
100%
of
the
field
blanks,
and
median
recoveries
of
94.4%
in
306
field
matrix
spikes
and
93.0%
in
1000
lab
control
spikes,
each
at
spiking
levels
of
0.1
:
g/
L.
These
data
suggest
an
adequate
level
of
detection
of
carbaryl
in
the
method
used
in
the
NAWQA
survey
of
surface
and
ground
water.
See
the
additional
discussion
at
the
end
of
this
document
for
further
information
regarding
recoveries
in
spiked
surface
and
ground
water.

EFED
Response:

EFED
has
revised
the
text
to
read
"Carbaryl
is
the
second
most
widely
detected
insecticide
after
diazinon
in
the
USGS
NAWQA
program
(http://
water.
usgs.
gov/
nawqa/
nawqa_
home.
html).
Carbaryl
was
detected
in
46%
of
36
NAWQA
study
units
between
1991
and
1998.
The
reported
concentrations
are
believed
to
be
reliable
detections
but
have
greater
than
average
uncertainty
in
quantification.
The
data
in
the
NAWQA
database
are
amended
with
an
"E"
qualifier
to
indicate
the
variability
found
in
the
analysis.
This
suggests
that
the
reported
values
may
not
represent
the
maximum
concentrations
that
exist.

Page:
35
Paragraph:
2
Line:
7
EPA
comment:
…at
about
0.1
percent
of
the
amount
used
in
the
basins
(Larson
et
al.,
1999)
.
The
estimated
carbaryl
use
on
in
agricultural
applications
is
about
4
million
pounds
suggesting
that
400,000
pounds
are
delivered
to
the
nations
streams
draining
agricultural
areas.

Aventis'
response:
This
estimated
use
of
carbaryl
for
agricultural
applications
over­
estimates
the
use
of
carbaryl
by
about
1
million
pounds.
BEAD
and
USGS
data
cited
on
pages
6
and
7
are
consistent
with
lower
total
pounds
of
carbaryl
applied.
In
addition,
0.1
percent
of
4
million
pounds
would
be
4,000
pounds,
not
400,000
pounds.
If
the
1987
–
1996
average
of
2.5
million
pounds
carbaryl
is
used
in
the
calculation,
the
total
load
suggested
to
be
delivered
to
streams
draining
agricultural
areas
would
be
2,500
pounds.
58
EFED
Response:

EFED
concurs
with
the
registrant's
comments
and
the
text
has
been
revised
to
read
"A
significant
portion
of
the
total
carbaryl
applied
was
transported
to
streams.
In
areas
with
high
agricultural
use
the
load
measured
in
surface
waters
was
relatively
consistent
across
the
country
at
about
0.1
percent
of
the
amount
used
in
the
basins
(Larson
et
al.,
1999)
http://
water.
wr.
usgs.
gov/
pnsp/
rep/
wrir984222/
load.
html.
The
estimated
carbaryl
use
on
in
agricultural
applications
is
about
2.5
million
pounds
suggesting
that
2,500
pounds
are
delivered
to
the
nations
streams
draining
agricultural
areas.

Registrant
Monitoring
Study
Page:
35
Paragraph:
4
Line:
11
EPA
comment:
Carbaryl
was
analyzed
by
HPLC/
MS
with
a
limit
of
detection…
Aventis'
response:
The
analytical
method
used
by
the
registrant
in
the
surface
water
monitoring
study
uses
tandem
mass
spectrometry
(MS/
MS)
as
the
detection
method.
This
type
of
detection
involves
quantification
of
"daughter"
ions
from
a
selected
mass
fragment
and
is
more
selective
than
an
MS
method.
Therefore,
to
accurately
reflect
these
differences,
the
method
should
be
labeled
as
HPLC/
MS/
MS.

EFED
Response:

EFED
concurs
with
the
registrant's
comments
and
the
text
has
been
revised
to
read
"Carbaryl
was
analyzed
by
HPLC/
MS/
MS
with
a
limit
of
detection
of
0.002
ppb
(2
ppt)
and
a
limit
of
quantitation
(LOQ)
of
0.030
ppb
(30
ppt)."

Page:
36
Paragraph:
3
Line:
9
EPA
comment:
In
several
cases
finished
water
had
higher
concentration
than
raw
water,
and
finished
water
had
detectable
carbaryl
when
the
raw
did
not.
The
highest
concentration
measured
was
in
finished
water
(0.18
ppb).
Raw
water
sampled
at
the
same
time
had
much
lower
concentration
(0.010).
59
Aventis'
response:
This
statement
is
misleading
and
certainly
does
not
consider
the
analytical
uncertainty
for
concentrations
below
the
level
of
quantification
and
near
the
level
of
detection.
There
were
only
two
cases
when
finished
water
was
greater
than
raw
water
when
the
concentrations
in
finished
water
were
greater
than
0.01
ppb
(only
one­
third
of
the
quantification
limit).
One
case
was
when
the
raw
water
was
0.009
ppb
and
the
finished
water
was
0.011
ppb.
These
two
analyses
are
essentially
equivalent,
especially
considering
that
they
are
only
about
a
third
of
the
quantification
limit.
The
other
case
was
at
the
Deerfield
community
water
system.
This
drinking
water
facility
uses
a
small
river
without
a
reservoir
as
a
source
for
a
small
Community
Water
System.
Farms
are
located
immediately
upstream
of
the
facility.
The
intake
is
also
not
continuous
(shut
down
over
weekends).
Therefore,
getting
a
matching
sample
is
quite
difficult,
especially
for
a
short
duration
spike
as
a
result
of
spray
drift,
summer
thunderstorm,
or
perhaps
a
spill
that
almost
immediately
enters
the
river
a
runoff
event.
The
rarity
of
this
event
is
demonstrated
by
the
absence
of
residues
of
this
magnitude
the
next
year
(2000).
Samples
collected
through
this
time
of
the
year
in
2001
also
do
not
indicate
a
similar
event.
Although
the
data
from
this
site
cannot
be
used
to
determine
the
peak
concentration,
the
data
provide
a
distribution
of
residues
through
the
three
year
period
which
will
define
up
to
the
99
th
percentile
concentration
of
the
distribution.

The
Deerfield,
Michigan
community
water
system
is
one
of
the
systems
in
which
the
greatest
variability
of
residues
would
be
expected.
Most
of
the
other
community
water
systems
are
located
on
larger
rivers,
lakes,
or
reservoirs.

Because
the
design
of
study
called
for
analysis
of
finished
water
only
when
there
were
residues
in
the
raw
water,
there
was
only
one
finished
sample
analyzed
when
the
raw
water
contained
no
residues.
This
sample
was
collected
at
the
Deerfield
community
water
system
at
the
sampling
interval
after
the
finding
of
0.16
ppb
in
the
Deerfield
system.
The
residue
level
in
this
sample
was
0.004
ppb.
The
difference
between
0.004
ppb
and
non­
detect
is
insignificant,
and
if
real
can
probably
be
attributed
to
water
at
much
higher
concentrations
remaining
in
the
system
from
the
previous
week.

EFED
Response:

The
registrant's
comments
point
out
a
major
flaw
in
the
water
monitoring
study
design.
The
study
should
have
analyzed
finished
water
at
all
sampling
times.
Because
of
this
and
other
shortcomings
discussed
previously,
the
results
of
this
study
cannot
be
used
to
evaluate
the
effects
of
treatment
on
carbaryl.

Page:
36
Paragraph:
4
Line:
1
EPA
comment:
Non­
targeted
monitoring,
such
as
the
NAWQA
program,
has
shown
much
higher
concentrations
occur
indicating
that
this
study,
while
useful,
can
not
be
used
to
describe
the
overall
distributions
that
occur
throughout
the
entire
use
area.
Aventis'
response:
60
The
targets
of
the
drinking
water
monitoring
conducted
by
the
registrant
and
the
NAWQA
program
are
different.
The
NAWQA
program
characterized
surface
water
concentrations
within
a
study
area
while
the
Aventis
drinking
water
monitoring
measured
residues
in
inlets
and
outlets
of
drinking
water
facilities.
Also
the
drinking
water
monitoring
program
considered
only
use
areas
with
drinking
water
supplies.
However,
for
FQPA
dietary
assessments,
the
appropriate
target
is
drinking
water
rather
than
surface
water.

The
main
reason
why
the
drinking
water
monitoring
study
did
not
show
residues
as
high
as
in
the
NAWQA
program
is
the
location
of
the
sampling
points.
Drinking
water
supplies
tend
to
be
located
on
larger
surface
water
bodies
than
NAWQA
sampling
points
(or
in
other
words,
the
intakes
for
community
water
systems
tend
to
be
downstream
of
NAWQA
sampling
points).
This
additional
time
allows
for
additional
degradation
and
dilution
to
occur.
Finding
the
highest
concentration
at
the
Deerfield,
Michigan
system
is
not
surprising
since
this
intake
is
on
one
of
the
smallest
surface
water
bodies
included
in
the
monitoring
study
(see
response
to
Page:
36,
Paragraph:
3,
Line:
9
above
for
a
more
detailed
explanation).

EFED
Response:

The
registrant's
comments
express
their
perspective
on
non­
targeted
monitoring
studies
and
do
not
reflect
an
error
in
the
risk
assessment.

Page:
36
Paragraph:
4
Line:
4
EPA
comment:
This
study
does
not
provide
sufficient
information
to
allow
estimation
of
actual
peak
and
mean
concentrations
that
actually
occur
in
all
use
areas.
Aventis'
response:
Because
most
of
the
samples
did
not
contain
carbaryl
residues,
accurate
estimates
of
the
actual
peak
and
mean
concentrations
can
not
be
obtained.
However,
the
distributions
obtained
from
all
sites
can
be
used
to
define
up
to
the
99
th
percentile
concentration.
The
average
cannot
be
accurately
determined;
however,
the
time­
weighted
average
is
only
slightly
above
the
limit
of
detection
(and
certainly
less
than
0.01
ppb)
at
all
20
sites.

The
peak
concentration
in
this
study
was
measured
at
a
community
water
system
on
a
small
river.
The
registrant
agrees
that
the
sampling
schedule
was
not
adequate
to
determine
the
true
peak
in
such
systems.
Most
of
the
other
community
water
systems
are
located
on
larger
rivers,
lakes,
or
reservoirs.
Therefore,
the
peak
values
are
not
likely
to
be
an
order
of
magnitude
greater
than
the
amounts
present
in
the
collected
samples.

The
distributions
obtained
in
this
study
are
suitable
for
use
in
dietary
exposure
assessments.
When
EPA
policy
establishes
what
percentile
concentration
is
an
appropriate
regulatory
endpoint,
then
these
percentiles
can
be
determined
for
each
of
the
community
water
systems
monitoring.
These
percentiles
can
then
be
compared
with
DWLOC
values
in
screening
assessments.
61
EFED
Response:

EFED
has
responded
previously
to
the
utility
of
Aventis'
water
monitoring
study.

Page:
37
Paragraph:
2
Line:
1
EPA
comment:
Only
limited
information
was
submitted
on
sampling
site
selection…
Aventis'
response:
The
summary
in
Appendix
I
of
this
response
provides
a
description
of
the
sites
considered
for
the
monitoring
study
and
the
rationale
for
the
selection
of
the
twenty
sites.
This
information
demonstrates
that
the
community
water
systems
selected
for
this
study
are
representative
of
the
systems
that
are
most
likely
to
contain
the
highest
concentrations
of
carbaryl
residues.

EFED
Response:

EFED
will
review
new
submissions
and
data
when
available.
This
does
not
represent
an
error
in
the
EFED
document
and
so
will
not
be
addresses
here.
It
will
be
addressed
in
an
appropriate
review
document
when
it
has
been
completed.

Page:
37
Paragraph:
3
Line:
3
EPA
comment:
This
should
include
an
explanation
of
why
this
study
did
not
observe
concentrations
as
high
as
those
found
in
other,
non­
targeted
studies,
and
how
the
results
of
this
study
can
be
related
to
concentrations
that
occur
throughout
the
country.
Aventis'
response:
The
main
reason
why
the
drinking
water
monitoring
study
did
not
show
residues
as
high
as
in
the
NAWQA
program
is
the
location
of
the
sampling
points.
Drinking
water
supplies
tend
to
be
located
on
larger
surface
water
bodies
than
NAWQA
sampling
points
(or
in
other
words,
the
intakes
for
community
water
systems
tend
to
be
downstream
of
NAWQA
sampling
points).
This
additional
time
allows
for
additional
degradation
and
dilution
to
occur.
Finding
the
highest
concentration
at
the
Deerfield,
Michigan
system
is
not
surprising
since
this
intake
is
on
one
of
the
smallest
surface
water
bodies
included
in
the
monitoring
study
(see
response
to
Page:
36,
Paragraph:
3,
Line:
9
above).

Since
the
drinking
water
study
targeted
drinking
water
systems
in
high­
use
watersheds,
the
data
from
this
study
are
representative
of
the
drinking
water
systems
most
likely
to
contain
carbaryl.
62
EFED
Response:

EFED
has
already
commented
on
the
utility
of
Aventis'
water­
monitoring
study.
Please
refer
to
the
previous
discussions.

Sacramento­
San
Joaquin
River
Delta
Page:
37
Paragraph:
4
Line:
4
­
5
EPA
comment:
Carbaryl
was
found
to
be
the
sole
causative
agent
at
one
of
20
sites…
The
toxicity
seemed
to
persist
for
several
days…
Aventis'
response:
The
statement
should
be
revised.
The
reference
cited
(Werner
et
al.,
2000)
lists
carbaryl
as
"the
primary
toxicant"
(not
as
the
"sole
causative
agent"),
even
though
an
unknown
was
also
found
at
the
same
time.
No
information
about
the
"unknown"
is
provided.
Both
conclusions
of
"sole
causative"
and
of
"primary
toxicant"
cannot
be
substantiated
without
further
evidence
about
the
nature
and
concentration
of
the
unknown.
Actually,
for
another
site
the
authors
concluded
about
the
unknown
found
there
"in
3
of
21
samples,
toxicity
observed
could
not
be
entirely
explained
by
the
identified
primary
toxicants."
Additionally,
it
is
at
least
questionable
if
the
analytical
method
employed
would
detect
all
potential
toxicants
beside
the
insecticides
it
was
set
up
for.

The
toxicity
seeming
to
persist
is
not
explained
or
substantiated
in
the
reference.
The
citation
of
such
dubious
results
should
be
removed
from
the
RED.

EFED
Response:

EFED
has
revised
the
text;
it
now
reads
"Carbaryl
was
found
to
be
the
[primary]
toxicant
at
one
of
20
sites
sampled
in
1995,
with
concentration
of
7.0
µg/
L."
Furthermore,
the
reference
cited
(Werner,
et
al.
2000)
is
taken
from
a
peer­
reviewed
journal,
i.
e.,
Environmental
Toxicology
and
Chemistry,
which
EFED
does
not
consider
to
be
a
dubious
source.

6.0
Hazard
and
Risk
Assessment
for
Aquatic
Organisms
Hazard
assessment
for
Aquatic
organisms
Estuarine/
Marine
Fish
Page:
39
Paragraph:
2
Line:
6
EPA
comment:
…carbaryl
water
concentration
of
1.2
µg/
ml…
63
Aventis'
response:
To
be
consistent
with
the
rest
of
the
document
the
units
should
be
presented
in
ppm
("
carbaryl
water
concentration
of
1.2
ppm")

EFED
Response:

EFED
concurs
with
the
registrant's
comments
and
the
text
has
been
revised
to
read
"1.2
ppb".

Aquatic
Plants
Page:
40
Paragraph:
2
Line:
6
EPA
comment:
Guideline
122­
2
is
not
fulfilled.
Aventis'
response:
The
chapter
should
be
revised.
As
detailed
above
(comments
to
Page
2
of
the
Memorandum),
studies
were
submitted
in
1992.
The
status
for
this
requirement
in
an
October
04,
2000
OPP
Guideline
Status
Report
(Chemical
Review
Management
System)
lists
the
guideline
122­
2
status
as
"Acceptable/
Satisfied".

EFED
Response:

As
EFED
has
noted
previously
in
its
response
to
comments,
EPA
requires
data
on
5
aquatic
plant
species.
The
registrant
has
provided
data
on
only
two
of
the
five
species
that
were
classified
as
acceptable
and
as
having
fulfilled
guideline
test
requirements.
Therefore,
EFED
is
requesting
that
aquatic
plant
studies
be
repeated
following
EPA
guidelines.

Risk
Assessment
for
Aquatic
Organisms
Page:
40
Paragraph:
4
Line:
3
EPA
comment:
…corresponding
levels
of
concern
(LOCs)
is
presented
in
Appendix
D.

Aventis'
response:
The
risk
quotients
are
currently
listed
in
Appendix
C.

EFED
Response:

EFED
concurs
with
the
registrant's
comments
and
the
text
has
been
revised;
the
sentence
now
reads
"A
detailed
analyses
of
risk
quotients
(RQs)
in
relation
to
their
corresponding
levels
of
concern
(LOCs)
is
presented
in
Appendix
C."
64
Estuarine/
Marine
Fish
Page:
42
Paragraph:
1
Line:
17/
18
EPA
comment:
Chronic
toxicity
studies
with
an
estuarine/
marine
fish
species
is
required.

Aventis'
response:
This
requirement
should
be
waived.
Given
the
relatively
short
half­
life
of
carbaryl
in
the
aquatic
environment
and
the
low
acute
risk,
it
is
unlikely
that
estuarine/
marine
fish
species
would
be
exposed
to
a
chronic
risk.

EFED
Response:

This
is
not
an
error
and
is
more
appropriately
addressed
in
a
later
phase
of
the
reregistration
process.

Page:
42
Paragraph:
2
Line:
1
EPA
comment:
There
is
one
carbaryl
use
in
particular
that
presents
a
major
acute
and
chronic
risk
to
estuarine/
marine
fish.

Aventis'
response:
This
sentence
should
be
rephrased.
While
there
might
be
an
acute
risk
from
the
application
to
oyster
beds,
given
that
there
is
only
one
application
every
six
years
according
to
the
reference
cited
by
EPA,
it
is
improbable
that
estuarine/
marine
fish
would
be
exposed
to
a
chronic
risk.

EFED
Response:

In
a
study
by
Stonic
(1999)
application
of
carbaryl
to
mud
flats
in
Willapa
Bay,
Washington,
resulted
in
post­
spray
carbaryl
concentrations
at
sprayed
sites
ranging
from
2,000
to
3,400
ppb
by
2
days
after
treatment
(DAT),
180
to
220
ppb
by
30
DAT,
and
86
­
120
ppb
by
60
DAT.
These
data
suggest
that
the
potential
for
chronic
exposure
to
estuarine/
marine
fish
is
possible.
However,
EFED
has
rephrased
the
sentence
to
read
"There
is
one
carbaryl
use
in
particular
that
represents
a
potential
acute
and
chronic
risk
to
estuarine/
marine
fish."
The
full
reference
for
these
data
is:
Stonic,
Cynthia.
1999.
Screening
Survey
of
Carbaryl
(Sevin
™
)
and
1­
naphthol
Concentrations
in
Willapa
Bay
Sediments.
Washington
State
Department
of
Ecology.
Publication
No.
99­
323.
65
7.0
Hazard
and
Risk
Assessment
for
Terrestrial
Organisms
Hazard
Assessment
for
Terrestrial
Organisms
Mammalian
Page:
46
Paragraph:
4
Line:
1
EPA
comment:
With
a
rat
LD50
of
307
mg/
kg…
Aventis'
response:
Typographical
error,
the
rat
LD50
is
301
mg/
kg.

EFED
Response:

EFED
concurs
with
the
registrant's
comments
and
has
corrected
the
text
to
indicate
a
rat
LD50
of
301
mg/
kg.

Risk
Assessment
for
Terrestrial
Organisms
Avian
Risk
Nongranular
Formulations
Page:
47
Paragraph:
4
Line:
5
EPA
comment:
…levels
of
concern
(LOCs)
is
presented
in
Appendix
D.

Aventis'
response:
The
risk
quotients
are
currently
listed
in
Appendix
C.

EFED
Response:

EFED
concurs
with
the
registrant's
comments
and
has
revised
the
text
to
reflect
that
risk
quotients
and
their
associated
levels
of
concern
(LOCs)
are
presented
in
Appendix
C.

Page:
48
Paragraph:
1
Line:
3
EPA
comment:
…
for
34
of
43
uses
at
maximum
reported
rates,
and
for
37
of
72
uses
at
"average"
rates.
(Appendix
D,
…
Aventis'
response:
The
risk
quotients
are
currently
listed
in
Appendix
C.
66
EFED
Response:

EFED
concurs
with
the
registrant's
comments
and
has
revised
the
text
to
reflect
that
risk
quotients
and
their
associated
levels
of
concern
(LOCs)
are
presented
in
Appendix
C.

Granular
Formulations
Page:
48
Paragraph:
2
Line:
5
EPA
comment:
…for
any
of
the
granular
carbaryl
uses
(Appendix
D,
Table
6).

Aventis'
response:
The
risk
quotients
are
currently
listed
in
Appendix
C.

EFED
Response:

EFED
concurs
with
the
registrant's
comments
and
has
revised
the
text
to
reflect
that
risk
quotients
and
their
associated
levels
of
concern
(LOCs)
are
presented
in
Appendix
C.

Mammalian
Risk
Risk
to
Herbivores/
Insectivores:
Nongranular
Formulations
Risk
Quotients
for
Herbivores/
Insectivores
Based
on
Less
than
Maximum
Label
Use
Rates
Page:
48
Paragraph:
3
Line:
3
&
4
EPA
comment:
…
(Appendix
D,
Table
10a)
and
maximum
reported
(Doane
data)
use
rates
data
available
for
43
uses
(Appendix
D,
Table
10b)

Aventis'
response:
The
risk
quotients
are
currently
listed
in
Appendix
C.

EFED
Response:

EFED
concurs
with
the
registrant's
comments
and
has
revised
the
text
to
reflect
that
risk
quotients
and
their
associated
levels
of
concern
(LOCs)
are
presented
in
Appendix
C.
67
Risk
Quotients
for
Herbivores/
Insectivores
Based
on
Maximum
Label
Use
Rates
Page:
48
Paragraph:
6
Line:
1
EPA
comment:
Carbaryl
is
moderately
toxic
to
small
mammals
on
an
acute
oral
basis
(rat
LD50
=
307
mg/
kg)

Aventis'
response:
Typographical
error,
the
rat
LD50
is
301
mg/
kg.
By
using
the
lower
LD50
all
acute
mammalian
risk
quotients
will
change
slightly.

EFED
Response:

EFED
concurs
with
the
registrant's
comments
and
has
corrected
the
text
to
indicate
a
rat
LD50
of
301
mg/
kg.
The
mammalian
risk
quotient
tables
in
Appendix
C
and
the
ranges
reported
in
the
text
have
been
revised
to
reflect
the
modest
change
in
numbers.

Page:
49
Paragraph:
1
Line:
3
EPA
comment:
…corresponding
levels
of
concern
(LOCs)
is
presented
in
Appendix
D.
Aventis'
response:
The
risk
quotients
are
currently
listed
in
Appendix
C.

EFED
Response:

EFED
concurs
with
the
registrant's
comments.
The
sentence
has
been
revised
to
read
"A
detailed
analysis
of
mammalian
RQs
in
relation
to
their
corresponding
levels
of
concern
(LOCs)
is
presented
in
Appendix
C."

Risk
to
Granivores:
Nongranular
Uses
Chronic
risk:
Nongranular
Uses
Page:
50
Paragraph:
2
Line:
8
EPA
comment:
…summarized
in
Appendix
D,
Table
9.

Aventis'
response:
The
risk
quotients
are
currently
listed
in
Appendix
C.
68
EFED
Response:

EFED
concurs
with
the
registrant's
comments
and
has
revised
the
text
to
reflect
that
risk
quotients
and
their
associated
levels
of
concern
(LOCs)
are
presented
in
Appendix
C.

Reproduction
Effects
Page:
50
&
51
Paragraph:
4
/
1
EPA
comment:
(Review
of
alleged
reproduction
effects
of
carbaryl).

Aventis'
response:

The
paragraphs
should
be
changed.
The
literature
cited
in
these
paragraphs
show
ambivalent
results.
While
some
references
seem
to
support
the
claim
of
reproductive
effects,
other
references
do
not.
The
potential
for
reproductive
effects
in
mammals
was
evaluated
in
the
recently
submitted
2­
generation
study
in
rats.
No
reproductive
effects
were
seen
in
this
guideline
study.
The
NOAEC
of
75
ppm
was
based
on
pup
mortality.

EFED
Response:

EFED
believes
that
the
chronic
effects
cited
from
the
open
literature
are
legitimate.
As
stated
previously,
chronic
reproductive
tests
have
resulted
in
effects
that
support
EFED's
concerns
regarding
the
endocrine
disrupting
potential
of
carbaryl.
EFED
believes
that
the
chronic
effects
cited
from
rat
developmental
studies,
i.
e.,
reduced
reproduction,
disturbances
in
spermatogenesis,
increased
resorption
of
embryos,
increased
incidence
of
infertility
in
females
and
underdeveloped
testes
in
males,
also
represent
serious
reproductive
effects
that
support
EFED's
concerns
regarding
the
chronic
reproductive/
developmental
toxicity
of
carbaryl.
Just
because
one
study
failed
to
show
similar
effects
to
another,
EFED
does
not
believe
that
it
would
be
reasonable
to
discount
the
validity
of
the
earlier
studies.
If
anything,
the
data
strongly
suggests
that
additional
data
are
needed
to
better
understand
the
likelihood
of
adverse
effects.

Page:
51
Paragraph:
4
EPA
comment:
Feeding
2
or
20
mg/
kg
of
carbaryl
to
pregnant
rhesus
monkeys
(Macacca
mulatta)

Aventis'
response:
This
paragraph
should
be
deleted.
As
there
are
no
native
monkey
species
in
the
U.
S.,
this
reference
is
irrelevant
for
U.
S.
wildlife
species.
Additionally,
the
reference
cited
is
only
a
brief
abstract
article
consisting
of
one
17­
line
paragraph.
Such
information
should
not
be
the
basis
for
use
in
a
RED
risk
assessment.
69
EFED
Response:

The
basis
for
the
EFED
risk
assessment
is
the
mammalian
acute
(LD50
=
301
mg/
kg)
and
chronic
(NOAEC
=
80
ppm)
rat
toxicity
data.
The
data
from
rhesus
monkeys
are
used
to
further
characterize
risk.
While
the
registrant
is
correct
that
rhesus
monkeys
are
not
native
to
the
United
States,
these
animals
are
routinely
used
in
primate
research
and
are
considered
reasonable
surrogates
for
studying
the
effects
of
chemicals
on
humans.

9.0
References
(non­
MRID)

Some
of
the
references
cited
in
EPA's
list
are
not
full
scientific
articles,
but
only
abstracts
from
meetings
(e.
g.
DeNorsica,
1973;
Doughtery
et
al.
,
1971,
Chapin
et
al.
1997).
Such
"publications"
should
not
be
used
as
references
considered
in
risk
assessments.
Without
a
sufficient
description
of
methods
and
a
presentation
of
detailed
results
these
studies
cannot
be
evaluated
to
determine
if
the
findings
are
or
are
not
scientifically
plausible.
Similarly,
at
least
three
of
the
references
(Gladenko
et
al.
1970,
Krylova
et
al.
1975,
Smirnov
et
al.
1971)
cited
as
proof
for
reproductive
toxicity
are
in
Russian
in
Cyrillic
writing
making
an
appropriate
and
timely
evaluation
difficult.
Due
to
the
limited
review
time
during
the
30­
day
comment
period,
the
registrant
could
not
peruse
all
references.
A
more
detailed
response
will
be
provided
during
the
60­
day
comment
period.

EFED
Response:

EFED
has
cited
literature
from
peer­
reviewed
journals
and
considers
these
sources
to
be
reliable.
Furthermore,
the
registrant
is
providing
their
perspective
on
open
literature
and
is
not
citing
a
specific
error
in
the
risk
assessment.

Page:
59
EPA
comment:
Carmel,
R.
F.,
Imhoff,
J.
C.,
Hummel,
P.
R.,
Cheplick,
J.
M.
and
Donigan,
A.
S.,
1997.

Aventis'
response:
The
first
name
should
be
Carsel.

EFED
Response:

EFED
concurs
with
the
registrant's
comment
and
has
corrected
the
reference
to
reflect
the
correct
spelling
of
the
name
"Carsel".
70
Page:
59
EPA
comment:
Nkedi­
Kizza
and
Brown
(1988)

Aventis'
response:
The
date
should
be
1998.

EFED
Response:

EFED
concurs
with
the
registrant's
comment
and
has
corrected
the
reference
to
reflect
the
correct
date
of
publication,
i.
e.,
1998.

Appendix
A:
Environmental
Fate
Study
Reviews
(DERs)

Page:
62
ff
EPA
comment:
(Environmental
fate
DERs
are
included)

Aventis'
response:
The
DERs
should
not
be
included
in
the
RED.
Publication
of
DERs
together
with
the
RED
is
unusual
and
will
put
Aventis
in
a
competitive
disadvantage.

EFED
Response:

EFED
concurs
with
the
registrant's
comments
that
DERs
should
be
made
available
to
the
public
under
the
Freedom
of
Information
Act
after
they
have
been
reviewed
and
cleared
for
confidential
business
information.
EFED
also
wants
to
reduce
the
overall
size
and
level
of
detail
of
its
risk
assessment
for
readability.
EFED
does
not,
however,
take
a
position
regarding
Aventis'
statement
on
"a
competitive
disadvantage"
resulting
from
DER
publication.
71
Appendix
B:
Refined
Water
Memo
Aventis'
response:
This
memo
was
provided
as
an
electronic
copy
and
needs
to
be
inserted
into
the
document.
It
included
text
that
repeated
several
sections
of
the
EFED
document
and
it
included
PRZM
input
tables
for
the
drinking
water
concentrations
using
the
Index
Reservoir
scenario.
It
would
have
been
of
benefit
to
have
the
same
PRZM
inputs
for
the
"standard
pond"
scenarios
that
were
used
to
estimate
surface
water
concentrations
used
in
the
aquatic
risk
assessments.

EFED
Response:

The
full
text
of
the
Refined
Water
Memo
has
been
included
in
Appendix
B
of
the
EFED
chapter.
The
memo
includes
both
PRZM
input
and
output
files.

Appendix
C:
Ecological
Risk
Assessment
Toxicity
Endpoints
Used
in
the
Risk
Assessment
Page:
129
(e­
version)

EPA
comment:
Aventis'
response:

Mammalian
acute
oral
LD50
rat
=
307
mg/
kg
The
correct
LD50
is
301
mg/
kg
Mammalian
chronic
(reproduction)
NOAEC
rat
=
80
ppm
Th
e
r
e
s
u
l
t
o
f
t
h
e
recently
submitted
2­
generation
rat
study
should
be
used
(75
ppm)

EFED
Response:

As
indicated
previously,
EFED
has
corrected
the
typographical
error
regarding
the
mammalian
acute
oral
LD50
of
301
mg/
kg.
Additionally,
EFED
has
already
commented
regarding
the
recently
submitted
2­
generation
rat
study;
even
if
the
study
is
classified
as
acceptable,
the
change
in
NOAEC
from
80
ppm
to
75
ppm
will
not
significantly
affect
the
magnitude
of
the
risk
quotients.
Neither
of
these
changes
have
a
marked
impact
on
EFED's
risk
assessment.

Avian
Acute
and
Chronic
Risk
Page:
130
(e­
version)
Paragraph:
1
Line:
1
EPA
comment:
Since
the
avian
LC50
is
greater
than
5,000
ppm
(Appendix
E),
72
Aventis'
response:
The
toxicity
data
are
currently
listed
in
Appendix
D.

EFED
Response:

EFED
concurs
with
the
registrant's
comments
and
the
text
has
been
revised
to
read
that
toxicity
data
are
listed
in
Appendix
D.

Page:
132
–
135
(e­
version)
EPA
comment:
(Acute
Risk
Quotients
in
Tables
4
and
5,
as
well
as
throughout
the
document
were
a
reference
is
made
to
these
quotients)

Aventis'
response:
As
the
acute
risk
quotients
are
calculated
on
the
basis
of
an
LC50
of
>
5000
ppm,
the
quotients
should
be
given
as
"<
(value)",
not
just
the
value.
The
values
should
also
be
changed
accordingly
throughout
the
document
where
a
reference
is
made
to
these
quotients.

EFED
Response:

EFED
concurs
with
the
registrant's
comments
and
Appendix
C
Tables
4
and
5
have
been
revised
to
show
that
acute
risk
quotients
are
less
than
the
values
presented.
No
further
changes
were
necessary
in
the
text
since
acute
avian
risk
quotients
were
reported
as
being
less
than
levels
of
concern.

Risk
from
Exposure
to
Non­
granular
Products
Page:
137
–
147
(e­
version)
EPA
comment:
(Text
and
tables
7
­
10)
Aventis'
response:
Text
and
tables
should
be
revised.
A
rat
LD50
of
307
mg/
kg
was
used
to
calculate
the
acute
risk
quotients.
The
correct
value
is
301
mg/
kg.
For
calculation
of
the
chronic
risk
quotient
a
NOAEC
of
80
ppm
was
taken
from
a
developmental
study.
The
NOAEC
of
75
ppm
from
a
more
relevant
2­
generation
rat
study
recently
submitted
should
be
used
instead.

EFED
Response:

As
noted
previously,
the
mammalian
acute
LD50
value
has
been
corrected
to
301
mg/
kg
and
the
acute
risk
quotients
have
been
revised.
Additionally,
the
chronic
risk
quotients
are
still
based
on
73
a
NOAEC
of
80
ppm.
The
data
from
the
2­
generation
rat
study
have
not
been
reviewed;
however,
the
change
in
NOAEC
from
80
to
75
ppm
will
have
no
marked
effect
in
EFED's
risk
assessment.

Risk
from
Exposure
to
Granular
Products
Page:
147
&
148
(e­
version)
EPA
comment:
(Text
and
Table
11)

Aventis'
response:
Text
and
tables
should
be
revised.
A
rat
LD50
of
307
mg/
kg
was
used
to
calculate
the
acute
risk
quotients.
The
correct
value
is
301
mg/
kg.

EFED
Response:

As
noted
previously,
references
to
the
rat
LD50
have
been
corrected
to
represent
a
value
of
301
mg/
kg.
Table
11
has
been
corrected.

Aquatic
Plants
Page:
152
(e­
version)
EPA
comment:
Based
on
a
single
core
aquatic
plant
toxicity
study
available…
…recommended
that
toxicity
studies
with
Lemna
gibba,
Anabaena
flos­
aquae,
Skeletonema
costatum,
and
a
freshwater
diatom
be
submitted.
Aventis'
response:
The
respective
studies
were
submitted
to
the
Agency
in
1992
(see
comments
above
to
Page
2
of
the
Memorandum
for
a
complete
list
and
status).

EFED
Response:

As
noted
previously,
EPA
requires
data
on
5
aquatic
plant
species.
Only
two
of
the
five
species
provided
data
that
were
classified
as
acceptable
and
as
having
fulfilled
guideline
test
requirements.
Therefore,
EFED
is
requesting
that
aquatic
plant
studies
are
repeated
following
EPA
guidelines.
74
Appendix
D:
Toxicity
Assessment
Page:
157
(e­
version)
EPA
comment:
Table
1
(spelling
of
author
in
MRID
No.
00160000)

Aventis'
response:
The
author
of
MRID
No.
00160000
should
be
"Hudson
et
al.
".
Also,
it
is
not
obvious
why
the
same
reference
is
one
time
classified
"core"
and
six
times
"supplemental".
The
agency
should
reconsider
if
the
use
of
a
"supplemental"
study
(i.
e.,
rock
dove)
in
calculating
all
acute
RQ
values
is
justified.

EFED
Response:

Table
1
has
been
revised
to
contain
the
correct
spelling
of
the
reference
"Hudson
et
al."
Study
classifications
reported
in
Table
1
are
based
on
whether
recommended
species
were
used
for
testing.
The
only
study
reported
in
Table
to
use
the
recommended
species,
i.
e.,
mallard
ducks,
is
classified
as
core;
the
remaining
studies
did
not
use
recommended
species
and
thus
are
classified
as
supplemental.

Birds,
Chronic
Toxicity
Page:
158
(e­
version)
Paragraph:
3
EPA
comment:
Bird
kills
attributed
to
carbaryl
and
involving
blackbirds,
ducks,
starlings,
grackles
turkey,
and
cardinals
have
been
reported
in
Pennsylvania,
Virginia,
New
Jersey,
North
Carolina
and
Michigan
(#
1002048­
001,
#1000802­
001,
#1007720­
020,
##
1000799­
003,
#1004375­
004).

Aventis'
response:
The
paragraph
should
be
moved
to
the
acute
bird
section.
Also,
only
individuals
familiar
with
this
information
will
recognize
the
numbers
as
the
incident
numbers
from
the
EIIS
database.
An
appropriate
reference
should
be
inserted
here
and
in
similar
citations.

EFED
Response:

EFED
concurs
with
the
registrant's
comments
and
the
paragraph
has
been
moved
to
the
discussion
on
acute
avian
toxicity.
Additionally,
a
reference
has
been
inserted
into
the
paragraph
indicating
that
the
information
was
based
on
6(
a)
2
ecological
incident
data.
75
Page:
158
Paragraph:
1
Line:
2
&
3
EPA
comment:
Exposure
to
carbaryl
at
levels
equal
to
or
greater
than
1000
ppm
in
the
mallard
duck
results
in
adverse
reproduction
effects,
such
as
decrease
in
number
of
eggs
produced
include
cracked
eggs,
fertility,
embryonic
mortality,
and
hatching
success.

Aventis'
response:
The
sentence
should
be
changed.
The
embryonic
mortality
and
the
hatching
success
were
not
different
from
the
control.

EFED
Response:

As
stated
previously,
although
the
data
evaluation
record
for
the
avian
reproduction
study
lists
increased
embryonic
mortality
and
reduced
hatching
success
as
significant
effects,
reference
to
these
two
effects
has
been
deleted
from
the
text
since
the
original
study
by
Fletcher
was
not
available
for
secondary
review.
However,
reduced
egg
production,
increased
incidence
of
cracked
eggs
and
decreased
fertility
are
reproductive
effects
that
support
EFED's
concerns
regarding
the
endocrine
disrupting
potential
of
carbaryl.

Mammals,
Acute
and
Chronic
Page:
158
&
159
(e­
version)
EPA
comment:
(rat
LD50
of
307
mg/
kg,
NOAEC
80
ppm)
Aventis'
response:
The
acute
LD50
value
for
rat
should
be
corrected
to
301
mg/
kg,
and
the
chronic
NOEAC
to
75
ppm
from
the
2­
generation
rat
study.

EFED
Response:

As
noted
previously,
the
mammalian
acute
LD50
value
has
been
corrected
to
301
mg/
kg
and
the
acute
risk
quotients
have
been
revised.
Additionally,
the
chronic
risk
quotients
are
still
based
on
a
NOAEC
of
80
ppm.
Data
from
the
2­
generation
rat
study
have
not
been
reviewed;
however,
the
change
in
NOAEC
from
80
to
75
ppm
will
have
no
marked
effect
in
EFED's
risk
assessment.
76
Freshwater
Fish,
Acute
Page:
161
(e­
version)
EPA
comment:
Table
6
Aventis'
response:
The
study
classification
of
reference
MRID
40098001
(Mayer
&
Ellersieck,
1986)
should
be
reconsidered
(and
handled
in
a
consistent
fashion).
A
number
of
times
the
reference
is
classified
"core",
while
in
other
instances
the
classification
is
"supplemental".
The
reference
is
an
overview
article
with
little
description
of
test
methods,
analytical
procedures,
GLP,
or
study
details.
The
results
are
generally
listed
in
extensive
tables
(although
summarized
in
the
text
for
some
chemicals).
Such
a
review
article
cannot
be
regarded
as
a
"core"
study
equivalent
to
the
guideline
studies
that
have
to
be
prepared
by
registrants.
Also,
such
studies
with
insufficient
test
method
descriptions
should
not
be
used
in
a
risk
assessment
as
the
primary
source
of
information.
A
submission
based
on
such
data
would
have
certainly
been
rejected
by
the
Agency
EFED
Response:

The
classification
of
Mayer
and
Ellerieck
(1986)
data
reported
in
Table
6
as
either
core
or
supplemental
depends
on
whether
EPA­
recommended
species
were
used
for
testing.
Unlike
avian
toxicity
studies
where
only
a
limited
number
of
species
are
recommended
for
testing,
there
is
a
broad
range
of
fish
species
that
EPA
views
as
acceptable
for
testing.
In
Table
6,
chinook
salmon
were
the
only
species
not
recommended
by
EPA
for
testing;
therefore,
the
data
based
on
Chinook
salmon
were
classified
as
supplemental.

The
only
acceptable
data
available
on
technical
grade
carbaryl
other
than
a
study
on
largemouth
bass
by
Johnson
and
Finley
(1980)
were
from
Mayer
and
Ellersieck
(1986).
The
registrant
is
encouraged
to
submit
data
on
the
acute
toxicity
of
technical
grade
carbaryl
to
address
the
uncertainties
that
they
have
identified.

Freshwater
Invertebrates,
Acute
Page:
163
(e­
version)
EPA
comment:
Table
9
Aventis'
response:
The
study
classification
of
reference
MRID
40098001
(Mayer
&
Ellersieck,
1986)
should
be
reconsidered
(and
handled
in
a
consistent
fashion).
A
number
of
times
the
reference
is
classified
"core",
while
in
other
instances
the
classification
is
"supplemental".
The
reference
is
a
review
article
with
little
description
of
test
methods,
analytical
procedures,
GLP,
or
77
study
details.
The
results
are
generally
listed
in
extensive
tables
(although
summarized
in
the
text
for
some
chemicals).
Such
an
overview
article
cannot
be
regarded
as
a
"core"
study
equivalent
to
the
guideline
studies
that
have
to
be
prepared
by
registrants.
Also,
such
studies
with
insufficient
test
method
descriptions
should
not
be
used
in
a
risk
assessment
as
the
primary
source
of
information.

EFED
Response:

The
classification
of
Mayer
and
Ellerieck
(1986)
data
reported
in
Table
6
as
either
core
or
supplemental
depends
on
whether
EPA­
recommended
species
were
used
for
testing.
As
with
the
freshwater
fish
studies
discussed
previously,
the
registrant
is
encouraged
to
submit
data
on
the
acute
toxicity
of
technical
grade
carbaryl
to
address
the
uncertainties
that
they
have
identified.

Estuarine
and
Marine
Invertebrates,
Acute
Page:
165
(e­
version)
EPA
comment:
Table
13,
reference
for
glass
shrimp:
Mayer
&
Ellerersieck
Aventis'
response:
The
reference
should
be
corrected
in
Mayer
&
Ellersieck.

EFED
Response:

EFED
concurs
with
the
registrant's
comments
and
the
reference
in
Table
13
has
been
corrected
to
read
"Mayer
&
Ellersieck
(1986)."

Page:
167
(e­
version)
Table
15
EPA
comment:
Table
15,
reference
for
MRID
No.
00265665
Aventis'
response:
The
reference
for
MRID
No.
00265665
should
also
contain
the
citation
of
an
author.

EFED
Response:

The
reference
to
MRID
00265665
(Eastern
oyster
LC50
=
2.5
ppm)
has
been
deleted
from
Table
15.
78
DISCUSSION
EFED
Response:

EFED
has
already
responded
to
all
of
the
issues
discussed
in
this
section.
The
reader
is
referred
to
earlier
responses
to
comments.

1.
Surface
Water
Concentrations
Summary
of
Registrant
Surface
Water/
Drinking
Water
Monitoring
Program
In
section
V,
page
31
EPA
states
that
the
modeling
simulations
provide
a
conservative,
though
not
unreasonable,
estimate
on
possible
concentrations
in
drinking
water.
The
data
from
the
registrant
drinking
water
monitoring
program
provide
the
best
estimate
of
concentrations
of
carbaryl
in
drinking
water.
This
study
uses
the
sampling
design
for
acute
endpoints
recommended
in
industry/
EPA
meetings
during
1999
(weekly
sampling
during
times
of
peak
concentrations
over
a
three
year
period).
Twenty
sites
representing
the
highest
carbaryl
use
areas
were
selected
based
on
the
information
provided
in
Appendix
I.
These
included
16
sites
in
agricultural
areas
and
4
locations
in
urban
areas.
Samples
were
collected
from
the
inlet
and
outlet
water
at
each
sampling
interval.
Outlet
samples
were
only
analyzed
when
residues
were
present
in
the
inlet
samples.
The
analytical
method
had
a
limit
of
quantification
of
0.030
ppb
and
a
limit
of
detection
of
0.002
ppb.

Table
1
summarizes
the
results
of
the
monitoring
at
each
of
the
20
community
water
systems.
The
maximum
concentration
observed
was
0.16
ppb
(average
of
four
samples,
the
highest
was
0.18
ppb)
in
a
finished
water
sample
from
the
Deerfield
community
water
system
located
on
the
River
Raisin
in
Lenawee
County,
Michigan.
There
were
only
five
other
samples
above
the
limit
of
quantification
of
0.030
ppb.
One
was
a
raw
water
sample
containing
0.31
ppb
from
the
Little
Potato
Slough
Mutual
community
water
system
near
Lodi
in
San
Joaquin
County,
California
(the
source
is
the
Little
Potato
Slough).
The
corresponding
finished
water
sample
was
0.007
ppb.
A
second
one
was
a
raw
water
sample
in
Brockton,
MA,
which
contained
0.031
ppb.
No
detectable
residues
were
found
in
the
corresponding
finish
water
sample.
The
last
three
samples
were
from
the
Shades
Mountain
plant
of
the
Birmingham
community
water
system
on
the
Cahaba
River
in
Jefferson
County,
Alabama.
Two
were
raw
and
finished
samples
of
0.038
and
0.032
ppb
at
the
same
sampling
interval
in
2001.
The
other
sample
was
0.035
ppb
in
the
raw
water
in
a
2000
sample
(the
corresponding
finished
sample
did
not
contain
carbaryl
residues.
All
residues
were
transient
so
the
time­
weighted
average
concentration
of
carbaryl
in
each
of
the
years
was
0.005
ppb
or
less
at
all
20
community
water
systems.
79
Table
1.
Summary
of
Results
from
the
Carbaryl
Drinking
Water
Monitoring
Study.

Site
Major
Uses
Maximum
Concentration
(ppt)
T
W
A
C
o
n
c
.
(ppt)*
in
Outlet
Water
Inlet
Water
Outlet
Water
1999
2000
2001*
*
1999
2000
2001**
1999
2000
Manatee,
FL
citrus
9
3
ND
11
ND
NA
1
1
West
Sacramento,
orchards,
3
24
ND
3
10
NA
1
1
Lodi,
CA
orchards,
12
31
ND
4
7
NA
1
1
Riverside,
CA
grapes,
tree
8
ND
ND
ND
NA
NA
1
1
Lake
Elsinore,
citrus
ND
3
6
NA
NA
Analysis
1
1
Corona,
CA
citrus
ND
ND
ND
NA
NA
NA
1
1
Beaumont,
TX
various
ND
ND
ND
NA
NA
NA
1
1
Point
Comfort,
rice,
tree
18
5
ND
ND
ND
NA
1
1
Penn
Yan,
NY
grapes,
ND
23
ND
NA
ND
NA
1
1
Westfield,
NY
grapes,
21
5
ND
ND
9
NA
1
1
Jefferson,
OR
vegetables,
ND
10
ND
NA
ND
NA
1
1
Coweta,
OK
pecans
4
ND
***
ND
NA
***
1
1
Pasco,
WA
apples,
2
3
ND
ND
ND
NA
1
1
Manson,
WA
apples
ND
ND
ND
NA
NA
NA
1
1
Deerfield,
MI
vegetables
10
4
ND
160
ND
NA
5
1
Brockton,
MA
cranberries
31
27
ND
ND
3
NA
1
1
East
P
oint,
G
Ahome
a
nd18184
3
8
ND11
Midlothian,
TX
home
and
14
ND
14
ND
NA
ND
1
1
Cary,
NC
home
and
4
ND
ND
ND
NA
NA
1
1
Birmingham,
AL
home
and
23
35
38
ND
ND
32
1
1
*
Annual
Time
Weighted
Concentration,
outlet
values
substituted
for
inlet
values
when
available;
values
below
the
detection
limit
were
considered
to
be
half
the
detection
limit.
**
Results
represent
one
to
six
months
of
sampling
into
the
third
year
program.
***
No
results
available
for
the
third
year
of
sampling.
ND
Not
detected.

NA
No
outlet
samples
analyzed
due
to
carbaryl
residues
not
being
detected
in
inlet
samples.
80
Summary
of
Surface
Water
Data
from
the
NAWQA
Program
In
Section
1
page
3,
Section
4
page
28
and
in
Section
5
page
34,
EPA
has
summarized
the
available
surface
water
monitoring
data
from
the
NAWQA
program
as
having
detections
in
46%
of
the
36
NAWQA
study
units
between
1991
and
1998
with
a
maximum
concentration
of
5.5
ppb.
The
following
tables
summarize
the
carbaryl
analyses
presently
available
from
this
database.

Table
2
is
a
summary
of
the
carbaryl
detections
in
the
updated
database
analysis
recently
reported
by
Larson
(2001).
This
analysis
was
conducted
only
for
samples
collected
during
a
oneyear
period
of
the
most
intensive
sampling
from
each
of
the
sampling
sites.
Numerous
samples
were
excluded
from
this
analysis
as
described
by
Larson:

"A
few
sites
with
sufficient
sampling
for
pesticides
were
excluded
from
the
analysis,
in
order
to
minimize
bias
caused
by
over­
representation
of
a
particular
land
use
or
agricultural
setting.
…
The
sampling
requirements
for
a
site
to
be
included
in
the
analysis
were
a
minimum
of
8
samples
collected
in
6
or
more
months
during
the
1­
year
period.
In
addition,
samples
must
have
been
collected
during
the
expected
period
of
elevated
pesticide
concentrations.
At
most
of
the
sites
used
in
this
analysis,
20
to
30
samples
were
collected
during
the
selected
1­
year
period.…
Not
all
samples
collected
during
the
year
at
each
site
were
used
in
the
calculation
of
the
summary
statistics,
however.
Samples
collected
as
part
of
a
fixed­
frequency
sampling
schedule
were
included,
along
with
a
much
smaller
number
of
samples
collected
during
selected
high
or
low
flow
conditions.
Samples
collected
over
a
storm
hydrograph,
or
as
part
of
a
study
of
diurnal
variability,
were
excluded
in
order
to
avoid
bias
resulting
from
repeated
sampling
during
extreme
conditions.
"

Table
2.
Carbaryl
Detections
Reported
in
Pesticides
in
Streams
Update
(Larson,
2001)

Site
Type
Number
of
Number
Carbaryl
Detection
Frequency
(%)
Maximum
All
>=
0.01
>=
0.05
>=
0.10
Agricultural
62
1560
9.2
5.
7
1.8
0.
9
5.2
Urban
Streams
22
611
43
37
19
12
3.2
Integrator
A
31
595
15
11
2.7
1.
2
0.43
A
Large
streams
and
rivers
Results
in
Table
3
and
Table
4
show
a
breakdown
of
all
the
carbaryl
analyses
reported
in
the
USGS
NAWQA
database,
which
was
downloaded
from
their
web
site
July
16,
2001.
The
data
are
reported
separately
for
the
GC/
MS
and
HPLC/
PDA
analyses.
81
Table
3.
Frequency
of
Carbaryl
Detections
by
GC/
MS
in
Different
Concentration
Ranges
Reported
in
the
NAWQA
Database
as
of
July
16,
2001
Land
Use
Number
<=
MDL
C
>0.003
to
>0.01
to
0.1
>0.1
to
1
ppb
>1
ppb
No.
%
No.
%
No.
%
No.
%
No.
%
All
Samples
10379
8388
80.82
617
5.94
1065
10.26
283
2.73
26
0.25
Agricultural
4349
3888
89.40
188
4.32
225
5.17
46
1.06
2
0.
05
Urban
1763
921
52.24
161
9.13
463
26.26
195
11.06
23
1.30
Mixed
A
3648
3022
82.84
247
6.77
345
9.46
33
0.90
1
0.
03
Other
B
619
557
89.98
21
3.39
32
5.17
9
1.
45
0
0
A
Large
streams
and
rivers.
Includes
all
of
the
"Integrator"
sites
listed
in
Larson,
et
al.
.,
1999
and
many
more.
B
Includes
forest,
rangeland,
mining,
etc.
C
The
method
detection
limit
(MDL)
for
carbaryl
analyzed
by
the
GC/
MS
method
is
0.003
:
g/
L,
but
updated
MDLs
presented
in
the
database
may
be
higher
for
some
analyses
and
are
included
in
this
category.

Table
4.
Frequency
of
Carbaryl
Detections
by
LC/
PDA
in
Different
Concentration
Ranges
Reported
in
the
NAWQA
Database
as
of
July
16,
2001
Land
Use
Number
<=
MDL
C
>0.008
to
>0.01
to
0.1
>0.1
to
1
ppb
>1
ppb
No.
%
No.
%
No.
%
No.
%
No.
%
All
Types
5516
5348
96.
95
9
0.16
93
1.69
54
0.98
12
0.22
Agricultural
2528
2509
99.
25
1
0.
04
13
0.
51
3
0.12
2
0.
08
Urban
1189
1064
89.
49
4
0.34
64
5.38
47
3.95
10
0.84
Mixed
A
1523
1501
98.
56
4
0.
26
15
0.
98
3
0.2
0
0
Other
B
27627499.
280
0
1
0.
3610.
360
0
A
Large
streams
and
rivers.
Includes
all
of
the
"Integrator"
sites
listed
in
Larson,
et
al.
.,
1999
and
many
more.
B
Includes
forest,
rangeland,
mining,
etc.
C
The
method
detection
limit
(MDL)
for
carbaryl
analyzed
by
the
LC/
PDA
method
is
0.008
:
g/
L,
but
updated
MDLs
presented
in
the
database
may
be
higher
for
some
analyses
and
are
included
in
this
category.

Summary
of
Carbaryl
Analytical
Methods
used
in
the
NAWQA
Program
In
a
number
of
instances
throughout
their
review,
EPA
has
made
reference
to
the
"poor
recovery"
for
carbaryl
noted
in
a
NAWQA
summary
document
(Larson,
1999).
In
this
document,
reference
is
made
to
mean
percent
recovery
of
24%
for
carbaryl
with
a
method
detection
limit
(MDL)
of
0.003
ppb.
The
Agency
cites
this
low
mean
recovery
several
times
as
evidence
that
the
concentrations
of
carbaryl
reported
in
the
database
widely
underestimate
the
actual
concentrations
of
carbaryl
in
the
water
samples.
This
claim
is
misleading
and
should
be
removed
from
each
location
in
the
draft
RED
for
reasons
discussed
below.

Two
analytical
methods
were
developed
as
part
of
the
NAWQA
program
and
both
of
them
have
been
used
in
the
analysis
of
carbaryl.
The
first
method,
used
for
a
majority
of
the
NAWQA
data
reported
for
carbaryl,
is
a
GC/
MS
method
with
an
MDL
of
0.003
ppb
(Zaugg,
et
al.,
1995).
The
second
method,
used
for
a
limited
number
of
samples
in
which
carbaryl
was
analyzed,
is
an
82
LC/
Photodiode­
Array
(PDA)
method
with
an
MDL
of
0.008
ppb
(Werner
et
al.
.,
1996).
In
the
NAWQA
database
the
quantitative
data
for
carbaryl
determined
by
the
GC/
MS
method
are
flagged
with
an
"E",
as
are
data
for
several
other
analytes,
indicating
that
the
analysts
have
noted
"the
potential
for
variable
performance"
in
the
analysis
of
carbaryl.
None
of
the
carbaryl
data
in
the
NAWQA
database
has
been
corrected
for
procedural
recoveries
that
were
noted
in
the
documents
described
above.
Both
of
these
methods
are
discussed
below
in
relation
to
the
recoveries
found
for
the
methods
and
the
potential
impact
this
could
have
on
the
analytical
data
for
carbaryl.

Gas
Chromatography/
Mass
Spectroscopy
Method
The
analytical
method
most
used
in
the
NAWQA
program
for
the
analysis
of
carbaryl
in
water
samples
is
the
GC/
MS
method
described
by
Zaugg,
et
al.,
1995.
In
this
multi­
residue
method,
the
analytes
are
first
removed
from
the
water
sample
by
sorption
on
a
C­
18
solid
phase
and
are
subsequently
eluted
from
the
solid
phase,
separated
by
GC
and
quantified
by
mass
spectroscopy
with
selected
ion
monitoring.
The
identity
of
each
analyte
is
confirmed
by
the
appropriate
combination
of
retention
time
and
the
ratios
of
three
mass
ions
that
are
characteristic
for
the
analyte.

The
recoveries
for
carbaryl
spiked
at
different
levels
into
three
different
types
of
water
and
analyzed
by
the
GC/
MS
method
are
shown
in
Table
5
Mean
percent
recoveries
of
151
and
202%
were
found
for
carbaryl
fortified
at
0.1
and
1.0
:
g/
L
in
reagent
grade
water.
A
preliminary
MDL
of
0.046
:
g/
L
was
calculated
for
the
0.1
:
g/
L
spiking
level.
Mean
percent
recoveries
of
10
and
75%
were
found
for
carbaryl
fortified
at
0.1
and
1.0
:
g/
L
in
a
surface
water
sample
collected
from
the
South
Platte
River.
However,
carbaryl
was
detected
at
0.18
:
g/
L
in
this
water,
or
nearly
twice
the
low
spike
level,
raising
questions
about
the
validity
of
this
result.
Mean
percent
recoveries
of
94
and
86%
were
found
for
carbaryl
fortified
at
0.1
and
1.0
:
g/
L
in
a
ground
water
sample
collected
from
a
well
in
Denver.
A
mean
recovery
value
of
24%
was
reported
for
reagent­
grade
water
fortified
at
a
level
of
0.03
:
g/
L
with
a
method
detection
limit
calculated
at
0.003
:
g/
L.

Table
5.
Recovery
and
Precision
for
Multiple
Determinations
of
Carbaryl
in
GC/
MS
Method
for
Carbaryl
Spiked
in
Different
Water
Samples
Water
type
Spike
Concentration
Mean
Recovery
(%)
MDL
Calculated
Reagent
Grade
0.
1
151
0.046
Reagent
Grade
1.
0
202
­
Surface
A
0.1
10
­
Surface
A
1.0
75
­
Ground
B
0.1
94
­
Ground
B
1.0
86
­
Reagent
Grade
0.
03
24
0.
003
A
Surface
water
was
collected
from
the
South
Platte
River
near
Henderson,
Colorado.
This
water
was
found
to
contain
significant
concentrations
of
several
pesticides
including
0.18
:
g/
L
carbaryl.
This
concentration
was
subtracted
from
the
values
determined
to
give
corrected
results.
B
Ground
water
was
collected
from
the
Denver
Federal
Center
Well
15.
83
Whereas
the
values
reported
by
Zaugg,
et
al.
(1995)
are
of
interest
in
validating
the
analytical
method,
they
are
not
as
useful
in
evaluating
the
validity
of
the
data
contained
in
the
NAWQA
database.
Therefore,
quoting
the
mean
recovery
value
of
24%
for
reagent
grade
water
spiked
with
carbaryl
at
0.03
:
g/
L
as
evidence
that
the
concentrations
reported
in
the
database
underestimate
the
actual
concentrations
of
carbaryl
present
in
the
water
samples
is
misleading.
A
more
useful
measure
of
the
validity
of
the
values
in
the
database
lies
with
the
quality
control
checks
that
have
been
incorporated
into
the
analysis
of
samples
in
the
NAWQA
program.

In
a
preliminary
report,
Martin
(1999)
reported
the
quality
control
data
collected
as
part
of
the
NAWQA
surface
and
ground
water
programs
by
the
1991
NAWQA
Study
Unit
teams
or
the
National
Water
Quality
Laboratory
(NWQL)
during
1992
to
1996.
The
data
that
were
compiled
includes
field
blanks,
laboratory
control
spikes
and
field
matrix
spikes,
which
are
defined
below
by
Martin.

"Field
blanks
were
collected
at
the
field
site
with
pesticide­
grade
blank
water
and
are
exposed
to
the
field
and
laboratory
environments
and
equipment
similarly
to
environmental
samples.
Field
blanks
measure
the
frequency
and
magnitude
of
contamination
(one
type
of
positive
bias)
in
environmental
water
samples
from
sources
in
the
field
and/
or
laboratory.
Contamination
is
the
main
cause
of
falsepositive
detections
(detecting
a
pesticide
in
a
sample
when,
in
truth,
it
is
absent)."

"Laboratory
control
spikes
measure
the
bias
and
variability
of
the
analytical
method
at
a
particular
concentration.
One
laboratory
control
spike
is
measured
in
each
analytical
set
of
environmental
samples.
The
laboratory
control
spike
has
the
target
pesticides
spiked
into
pesticide­
grade
blank
water
at
the
laboratory
and
extracted,
processed,
and
analyzed
like
environmental
samples.
Laboratory
control
spikes
analyzed
by
GCMS
were
spiked
at
0.1
µg/
L…"

"Field
matrix
spikes
measure
the
bias
and
variability
of
the
analytical
method
PLUS
any
potential
effects
caused
by
(1)
degradation
of
pesticides
during
shipment
to
the
laboratory,
(2)
inferences
in
the
determination
of
pesticides
from
unusual
characteristics
of
the
environmental
water
sample
("
matrix
effects"),
and
(3)
other
chemical
processes
that
cause
bias
or
variability
in
the
measurements
of
pesticides
in
environmental
water
samples.
Field
matrix
spikes
analyzed
by
GCMS
were
spiked
at
0.1
µg/
L,…"

All
of
the
carbaryl
analyses
in
the
field
blanks,
field
matrix
spikes
and
lab
control
spikes
were
conducted
following
the
same
method
described
by
Zaugg
et
al.,
1995
that
was
used
to
generate
a
majority
of
the
carbaryl
data
contained
in
the
NAWQA
database.
The
data
below
were
excerpted
from
Tables
1
to
4
of
the
Martin
report.
Carbaryl
is
found
in
these
tables
under
parameter
82680.

Out
of
145
samples
taken
as
ground
water
field
blanks,
carbaryl
was
not
detected
in
any
of
the
samples
indicating
a
lack
of
false
positives.
Out
of
171
samples
taken
as
surface
water
field
84
blanks,
carbaryl
was
reported
in
two
samples
(1.2%
false
positives)
at
reported
concentrations
of
0.009
and
0.012
:
g/
L.

A
summary
of
the
results
for
the
field
matrix
spikes
and
the
lab
control
spikes
is
presented
in
Table
6
Mean
recovery
for
the
306
field
matrix
spikes
was
115%
of
the
spiking
level
of
0.1
:
g/
L
with
a
median
recovery
of
94.4%
and
a
90
th
percentile
recovery
of
200%.
This
indicates
the
potential
for
the
method
to
over­
estimate
the
concentration
of
carbaryl
present
in
the
water
samples
and
is
consistent
with
the
initial
data
reported
for
the
reagent
water
samples
by
Zaugg
et
al.
(1995).
Mean
recovery
for
the
1000
lab
control
spikes
was
99.6%
of
the
spiking
level
of
0.1
:
g/
L
with
a
median
recovery
of
93%
and
a
90
th
percentile
recovery
of
185%.
These
data
suggest
an
adequate
level
of
detection
of
carbaryl
in
QC
samples
that
were
analyzed
as
part
of
the
same
process
used
in
the
NAWQA
survey
of
pesticides
in
surface
and
ground
water.
85
Table
6.
Percent
Recoveries
of
Carbaryl
Detected
by
the
NAWQA
GC/
MS
Method
in
Laboratory
Control
Spikes
and
Field
Matrix
Spikes
at
a
Spiking
level
of
0.1
:
g/
L
Sample
Type
Number
of
10
th
Median
Mean
90
th
Maximum
Field
Matrix
Spike
306
40
94.4
115.0
199.9
456
Laboratory
Control
1000
20
93.0
99.6
185.1
329
The
following
disclaimer
was
taken
verbatim
from
the
provisional
report
by
Martin
(1999)
and
pertains
to
the
data
provided
above
on
the
recovery
of
carbaryl
in
the
field
matrix
spike
samples.
"The
field
matrix­
spike
data
have
not
been
reviewed
thoroughly,
are
provisional,
and
are
subject
to
change.
Further
review
of
the
field­
spike
data
is
expected
to
identify
spikes
that
have
extremely
high
or
low
recoveries
because
the
spikes
either
were
improperly
collected
or
incorrectly
documented
in
the
NAWQA
QC
data
base.
The
expected
result
of
further
review
is
a
data
set
of
field
matrix
spikes
with
fewer
extreme
values
than
the
provisional
data
set
described
in
this
paper;
consequently,
the
provisional
data
set
provides
a
conservative
estimate
of
the
quality
of
the
NAWQA
pesticide
data.
Interpretations
of
field
matrix
spike
data
in
this
paper
are
not
expected
to
change
greatly
as
a
result
of
further
review
of
the
data,
however,
the
statistics
and
confidence
limits
reported
in
the
text
and
tables
will
change
on
further
review
(especially
for
pesticides
with
low
numbers
of
field
spikes
[less
than
50])."

High­
Performance
Liquid
Chromatography/
Photodiode­
Array
Method
Another
analytical
method
used
in
the
NAWQA
program
for
the
analysis
of
carbaryl
in
water
samples
is
the
LC/
PDA
method
described
by
Werner,
et
al.,
1996.
This
method
was
used
for
the
analysis
of
carbaryl
in
a
limited
number
of
samples
as
noted
above.
In
this
multi­
residue
method,
the
analytes
are
first
removed
from
the
water
sample
by
sorption
on
a
Carbopak­
B
solid
phase
extraction
cartridge
and
are
subsequently
eluted
from
the
solid
phase,
separated
by
HPLC
and
quantified
by
light
absorption
using
a
photodiode­
array
detector.
The
identity
of
each
analyte
is
confirmed
by
the
appropriate
combination
of
retention
time
and
light
absorption
characteristics.
The
recoveries
for
carbaryl
spiked
at
different
levels
into
three
water
samples
and
analyzed
by
this
method
is
shown
in
Table
7
The
recoveries
ranged
from
58%
to
84%
for
the
different
water
and
spiking
levels.
Laboratory
control
spikes
in
organic­
free
water
resulted
in
a
mean
recovery
of
61%
over
a
two­
year
sampling
period.
These
results
indicate
reasonable
levels
of
carbaryl
recovery
from
each
of
the
different
types
of
water
evaluated
for
the
method.
86
Table
7.
Recovery
and
Precision
for
Multiple
Determinations
of
Carbaryl
in
LC/
PDA
Method
for
Carbaryl
Spiked
in
Different
Water
Samples
Water
type
Spike
Concentration
Mean
Recovery
(%)
MDL
Calculated
Organic­
Free
0.1
82
0.
008
Organic­
Free
1.0
70
­
Surface
A
0.1
84
0.
016
Surface
A
1.0
84
­
Ground
B
0.1
58
0.
018
Ground
B
1.0
64
­
Organic­
Free
0.5
61
C
­
A
Surface
water
was
collected
from
the
South
Platte
River
at
Englewood,
Colorado.
B
Ground
water
was
collected
from
Jefferson
County,
Colorado
(Arvada
Well
14).
C
National
Water
Quality
Laboratory
results
produced
using
5
operators
and
7
instruments
over
2
years
(about
350
data
points).

Summary
of
Surface
Water
Data
from
the
California
DPR
Surface
Water
Database
In
Section
5
pages
34
to
37
EPA
has
summarized
surface
water
monitoring
data
from
various
sources.
One
source
not
included
in
this
discussion
is
the
California
Surface
Water
Monitoring
Database.
The
number
of
analyses
and
the
detections
of
carbaryl
residues
reported
in
the
database
are
summarized
in
Table
8.
Carbaryl
was
detected
at
levels
above
the
LOQ
in
only
5.1%
of
the
2,690
samples
analyzed.
The
mean
concentration
of
carbaryl
in
the
140
samples
above
the
LOQ
was
0.42
ppb.
The
highest
concentration
of
carbaryl
that
was
detected
was
8.4
ppb.

An
analysis
of
the
data
in
the
California
Department
of
Pesticide
Regulation's
surface
water
database
as
of
July
15,
2000
was
conducted
for
carbaryl.
The
following
summary
of
the
contents
of
the
database
is
adapted
from
information
provided
by
the
California
DPR.
The
database
contains
monitoring
results
for
pesticides
in
samples
taken
from
California
rivers,
creeks,
urban
streams,
agricultural
drains,
the
Delta,
and
urban
stormwater
runoff.
As
of
July
15,
2000,
the
database
contained
the
results
of
30
studies
conducted
by
federal,
state,
and
local
agencies,
private
industry,
and
an
environmental
group.
A
total
of
4,660
samples
were
taken
in
16
counties
from
January
1991
through
March
2000.
Each
record
in
the
database
is
the
result
of
one
analysis
for
a
pesticide
active
ingredient
or
breakdown
product.
The
database
contains
a
total
of
92,296
analytical
records.
Only
information
on
the
analytical
detection
of
carbaryl
in
these
water
samples
is
summarized
in
Table
8
below.

Table
8.
Carbaryl
Detections
Reported
in
California
DPR
Surface
Water
Monitoring
Database
Land
Use
Number
<=
LOQ
>0.003
to
>0.01
to
0.1
>0.1
to
1
ppb
>1
ppb
No.
%
No.
%
No.
%
No.
%
No.
%
All
Samples
2690
2553
94.91
13
0.48
55
2.04
55
2.04
14
0.52
Concentrations
of
analytical
results
that
are
reported
below
the
limit
of
quantification
are
reported
as
a
zero
in
the
database
concentration
field.
The
LOQs
for
the
different
methods
used
to
generate
the
data
contained
in
the
database
ranged
from
0.003
to
0.5
:
g/
L,
with
a
majority
of
the
samples
analyzed
with
an
LOQ
of
0.05
:
g/
L
or
less
(Table
9)
.
87
Table
9.
Limits
of
Quantification
for
Carbaryl
Analytical
Methods
Reported
in
California
DPR
Surface
Water
Monitoring
Database
LOQ
(
:
g/
L)
0.003
0.041
0.044
0.05
0.07
0.1
0.
5
Number
of
267
238
168
1353
92
53
146
88
2.
Ground
Water
Concentrations
In
Section
5
page
34
EPA
summarized
information
on
the
detection
of
carbaryl
in
groundwater
from
the
EPA
Pesticides
in
Groundwater
Database,
the
EPA
STORET
database
and
the
NAWQA
database.
Each
of
the
databases
shows
a
pattern
of
very
low
levels
of
carbaryl
detection
in
few
groundwater
resources.
These
analyses
confirm
several
statements
made
by
the
Agency
that
carbaryl
has
limited
potential
to
impact
groundwater
resources.
However,
on
page
2
of
the
Memorandum
issued
June
28,
2001,
in
conjunction
with
the
EFED
RED
chapter
for
carbaryl,
EPA
is
requiring
additional
information
on
"Surface
and
groundwater
monitoring
in
urban
and
suburban
use
areas
(non­
guideline)."
Based
on
the
characteristics
of
carbaryl
and
the
available
data
demonstrating
limited
impact
of
carbaryl
on
ground
water
resources,
additional
studies
to
evaluate
the
potential
for
carbaryl
to
contaminate
groundwater
are
unnecessary
and
unwarranted.

Summary
of
Ground
Water
Data
from
the
NAWQA
Program
In
Section
5,
pages
33
­
34,
EPA
has
summarized
ground
water
monitoring
data
available
for
carbaryl.
The
database
that
contains
the
most
extensive
evaluation
of
the
impact
of
the
most
recent
uses
of
carbaryl
on
ground
water
is
the
NAWQA
database.
One
deficiency
of
the
NAWQA
program
is
that
samples
are
targeted
to
agricultural
and
urban
areas
but
not
to
areas
treated
with
the
specific
chemical
being
analyzed.
However,
given
the
use
patterns
of
carbaryl,
the
use
of
carbaryl
has
certainly
occurred
near
a
number
of
these
wells.
Another
deficiency
is
that
when
residues
are
found,
that
while
they
may
be
representative
of
residues
in
ground
water,
they
may
not
be
representative
of
residues
in
ground
water
used
for
drinking
water
due
to
the
location
of
the
sampled
wells
relative
to
potable
drinking
water
wells.

EPA
cited
a
1998
review
of
the
NAWQA
database
by
Kolpin
and
stated:

"Carbaryl
was
detected
at
greater
than
the
detection
limit
(0.003
µg/
L)
in
1.1
%
of
groundwater
samples
from
1034
sites
across
the
U.
S.
by
U.
S.
G.
S.
NAQWA
(sic)
program.
The
maximum
observed
concentration
was
0.021
µg/
L."

This
1998
analysis
has
been
extended
by
additional
study
data
collected
by
the
NAWQA
program.
The
additional
data
continue
to
show
a
limited
number
of
low
level
detections
of
carbaryl
in
ground
water
samples.
Table
10
below
summarizes
a
more
recent
provisional
review
by
Kolpin
(2001)
of
the
updated
NAWQA
database.
Not
all
of
the
water
samples
were
used
to
calculate
the
summary
statistics
as
noted
by
Kolpin:

"To
preclude
bias
in
these
summary
statistics
from
wells
that
were
sampled
more
than
once,
the
data
set
was
condensed
such
that
each
well
had
a
single
pesticide
analysis.
This
generally
was
the
first
sample
collected.
However,
subsequent
samples
were
selected
if
these
samples
contained
more
pesticide
data
(i.
e.,
a
larger
number
of
pesticides
were
analyzed).
Wells
that
were
designed
to
be
a
part
of
both
a
land­
use
study
and
a
major
aquifer
survey
were
used
in
each
summary.
Because
of
89
uncertainties
in
the
source
of
water
and
contributing
land­
use
area,
springs
and
drains
were
excluded
from
these
summaries."

Table
10.
Carbaryl
Detections
Reported
in
Pesticides
in
Ground
Water
Update
(Kolpin,
2001)

Site
Type
Number
Carbaryl
Detection
Frequency
(%)
Maximum
All
>=
0.01
>=
0.05
>=
0.10
Agricultural
Land­
1244
0.40
0.16
0.0
0.
0
0.019
Urban
Land­
Use
634
2.1
1.
3
0.0
0.
0
0.031
Major
Aquifers
1849
0.59
0.54
0.05
0.05
0.539
90
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Binding
of
Naphthalene
and
"
­Naphthol
to
Soil:
Elucidation
of
Processes.
Environ.
Sci.
Technol.,
30:
1205­
1211.

Burgos,
W.
D.,
D.
F.
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92
Confidential
Business
Attachment
APPENDIX
1
Surface
Water
Monitoring
for
Residues
of
Carbaryl
in
High
Use
Areas
of
the
United
States
(Stone
Environmental,
Inc.
Report
#99­
1005­
F)
(hard
copy
provided).
93
Confidential
Business
Attachment
APPENDIX
2
Calculation
of
County
Average
Carbaryl
Use
Rates
(hard
copy
provided)