UNITED
STATES
ENVIRONMENTAL
PROTECTION
AGENCY
WASHINGTON,
D.
C.
20460
Office
of
Prevention,
Pesticides
and
Toxic
Substances
August
6,
2002
SUBJECT:
Carbaryl:
Agency
Response
To
Aventis
Crop
Science
Error
Correction
Comments
On
Revised
HED
Risk
Assessment
and
Supporting
Documents,
DP
Barcode:
D284591,
PC
Code:
056801
FROM:
Jeffrey
L.
Dawson,
Chemist/
Risk
Assessor
Reregistration
Branch
1
Health
Effects
Division
(7509C)

THRU:
Whang
Phang,
PhD,
Branch
Senior
Scientist
Reregistration
Branch
1
Health
Effects
Division
(7509C)

TO:
Anthony
Britten,
Chemical
Review
Manager
Reregistration
Branch
3
Special
Review
&
Reregistration
Division
(7508C)

Attached
is
the
Agency's
response
to
30
day
error
correction
comments
provided
by
Aventis
Crop
Science
on
the
previous
version
of
the
human
health
effects
risk
assessment
(D281420/
June
7,
2002).
The
registrant
comments
were
included
in
the
document
entitled
Human
Health
Risk
and
Supporting
Documents
­
Phase
1
Error
Correction
(Date:
July
12,
2002).
The
Agency's
human
health
risk
assessment
was
updated
based
on
a
number
of
the
comments
and
re­
issued
on
July
30,
2002
(D284580).
The
intent
of
this
document
is
to
illustrate
how
the
comments
were
considered
in
the
revisions
to
the
risk
assessment.
The
comments
addressed
the
risk
assessment,
the
product
and
residue
chemistry
chapter,
and
the
occupational
and
residential
risk
assessment.
Note
that
only
the
Agency
risk
assessment
and
not
the
supporting
documents
have
been
updated
at
this
point.
The
Agency
response
is
provided
for
each
set
of
comments,
respectively,
in
Sections
1,
2,
and
3
of
this
document
below.
2
Section
1:
Human
Health
Risk
Assessment
The
Aventis
Crop
Science
comments
on
the
human
health
risk
assessment
are
presented
below
as
well
as
the
Agency's
responses
to
each.

Aventis
Crop
Science
Comment
1:

EPA
statement:
The
company
name
of
the
registrant
is
listed
throughout
the
document
as
Aventis
Corporation,
Aventis
Crop
Sciences,
Aventis
Crop
Science,
and
Aventis
Crop
Science
Corporation.

Aventis'
comment:
Reference
should
be
either
to
Aventis
or
Aventis
CropScience.

Agency
Response
To
Aventis
Crop
Science
Comment
1:

The
Agency
has
used
Aventis
Crop
Science
throughout
the
document.

Aventis
Crop
Science
Comment
2:

1.0
Executive
Summary
Dietary
Risk
Estimates
(Page
7;
Paragraph
3;
Lines
4­
6)
EPA
statement:
"In
livestock
commodities,
carbaryl,
5,6­
dihydro­
5,6­
dihydroxy
carbaryl,
5­
methoxy­
6­
dydroxy
carbaryl
and
all
residues
which
can
be
hydrolyzed
to
carbaryl,
5,6­
dihydro­
5,6­
dihydroxy
carbaryl,
5­
methoxy­
6­
hydroxy
carbaryl
under
acidic
conditions
…."

Aventis'
comment:
Add
"and"
before
"5­
methoxy­
6­
hydroxy
carbaryl
under
acidic
conditions
….".

Agency
Response
To
Aventis
Crop
Science
Comment
2:

The
"and"
has
been
added.
3
Aventis
Crop
Science
Comment
3:

1.0
Executive
Summary
Aggregate
Risks
and
DWLOCs
(Page
11;
Paragraph
4;
Lines
9­
14)
EPA
statement:
"Additionally,
acute
dietary
risks
were
also
exceeded
for
infants
and
children
(1
to
6
years
old)
at
the
99.9
th
percentile
when
the
Carbamate
Market
Basket
Survey
(CMBS)
was
not
considered
in
the
assessment
(133%
of
aPAD).
However,
the
risk
picture
could
substantively
change
if
residential
risks
are
refined
based
on
updated
use
information
from
the
carbaryl
use
survey
yet
to
be
submitted
to
the
Agency,
and
the
Agency
uses
the
CMBS
data
even
with
the
caveats
associated
with
that
study."

Aventis'
comment:
This
statement
is
inconsistent
with
information
presented
elsewhere
in
the
HED
Chapter.
As
written,
the
statement
implies
that
the
Agency
has
not
yet
approved
the
use
of
the
CMBS
data
in
the
dietary
risk
assessment
for
carbaryl.
However,
EPA
states
in
the
Hazard
Characterization
section
of
the
Executive
Summary,
page
6,
paragraph
2,
line
9,
"Dietary
exposures
were
calculated
using
FDA
and
PDP
monitoring
data,
a
carbamate
market
basket
survey,
and
…"
which
indicates
that
the
EPA
approved
the
use
of
the
CMBS
data.
In
addition,
it
is
stated
on
pages
8
and
31
(Footnotes)
and
page
37,
first
paragraph:
"At
the
present
time,
information
from
the
industry­
sponsored
Carbamate
Market
Basket
Survey
has
been
approved
for
use
in
dietary
risk
assessments
with
appropriate
characterization
of
uncertainties
associated
with
the
conduct
of
the
study.
Hence,
the
use
of
these
data
in
this
assessment
should
be
considered
with
associated
caveats
…"

Agency
Response
To
Aventis
Crop
Science
Comment
3:

The
Agency
has
considered
this
and
other
comments
related
to
the
use
and
interpretation
of
the
carbamate
market
basket
survey
results
in
a
similar
fashion.
The
intent
of
the
Agency
in
any
risk
assessment
is
to
present
as
broad
a
picture
as
possible
to
risk
managers
so
they
can
make
the
most
informed
decisions
possible
given
the
resources
available.
This
approach
is
very
consistent
with
the
Agency's
available
guidelines
for
exposure
assessment
and
risk
characterization.

In
this
case,
both
the
CMBS
and
the
PDP
data
(as
well
as
the
other
data
used
in
the
Agency's
dietary
risk
assessment)
were
considered
to
be
acceptable
for
use
in
the
risk
assessment.
However,
both
sources
of
data
have
associated
uncertainties
such
as
the
rubbing
issue
in
the
CMBS.
Additionally,
it
should
be
noted
that
if
the
Agency
considers
multiple
sources
of
data
acceptable
for
risk
assessment,
it
does
not
mean
that
the
4
Agency
would
disregard
other
sources
of
information.
This
is
particularly
true
when
each
one
is
considered
to
be
of
high
quality
yet
still
has
uncertainties
associated
with
its
use.
As
such,
the
Agency
has
retained
the
comparative
risk
analyses
based
on
the
use,
or
not,
of
the
CMBS
in
the
recently
revised
risk
assessment
(D284580/
July
30,
2002).

Aventis
Crop
Science
Comment
4:

1.0
Executive
Summary
Issues
for
Consideration
(Page
16,
Paragraph
1,
Lines
19­
26)
EPA
statement:
It
should
also
be
noted
that
Aventis
Crop
Sciences
is
in
the
process
of
conducting
biological
monitoring
studies
in
residences
where
there
have
been
carbaryl
applications
(sampling
urine
from
children)
and
also
for
field
workers
during
harvesting
and
hand
thinning
operations
in
apples
and
cherries.
Preliminary
results
from
these
studies,
based
on
personal
communication
with
Aventis
scientists
(they
have
not
been
submitted
to
the
Agency
yet),
indicate
body
burden
levels
similar
to
those
calculated
by
the
Agency
for
risk
assessment
purposes.
For
example,
the
turf
risk
assessments
completed
by
the
Agency
are
intended
to
provide
upper
percentile
exposures.
The
data
from
the
monitored
children
appear
to
indicate
similar
results
a
the
upper
percentiles.

Aventis'
comment:
This
statement
does
not
accurately
reflect
the
true
scope
of
the
study
and
would
be
misleading.
The
comment
would
be
more
accurate
as
follows:
"It
should
also
be
noted
that
Aventis
CropScience
has
completed
and
is
in
the
process
of
submitting
to
the
Agency
a
biomonitoring
study
of
individuals
in
residences
following
the
application
by
a
member
of
the
household
to
the
lawn
and
either
the
vegetable
garden
or
ornamental
flowers.
A
biomonitoring
study
of
field
workers
during
harvesting
and
hand
thinning
operations
in
apples
and
cherries
will
also
be
submitted
to
the
Agency.
Based
on
personal
communication
with
Aventis
scientists,
preliminary
results
from
the
residential
biomonitoring
study
indicate
that
the
highest
percentiles
of
the
distribution
of
the
younger
children
in
the
homes
were
similar
to
those
predicted
in
the
Agency's
turf
risk
assessment
for
toddlers
that
are
intended
to
represent
the
higher
percentiles
of
the
exposure
distribution."

Agency
Response
To
Aventis
Crop
Science
Comment
4:

The
Agency
replaced
the
text
in
the
revised
assessment
with
that
suggested
by
Aventis
Crop
Science.
5
Aventis
Crop
Science
Comment
5:

4.0
Non­
Occupational
Risk
Assessment
and
Characterization
4.1
Summary
of
Registered
Uses
(Page
28;
Table
3:
Technical
and
Manufacturing
Carbaryl
Products)
Aventis'
comment:
Carbaryl
–
Technical
Products
°
EPA
Registration
No.
45735­
24
(99%),
Carbaryl
99%
Technical
Grade
Insecticide,
Burlington
Scientific
Corporation,
should
be
added
to
the
list
of
registered
carbaryl
technical.
°
EPA
Registration
No.
264­
325
(97.5%),
Aventis
CropScience,
should
be
included
in
the
list
of
manufacturing­
use
products.

Carbaryl
–
Manufacturing­
Use
Products
°
EPA
Registration
No.
5481­
190
(46%
FI),
AMVAC
Chemical
corporation
,
is
an
active
registration
and
should
be
added
to
the
list
of
Manufacturing­
Use
Products.
(It
is
listed
in
Table
1,
page
2,
of
the
Product
and
Residue
Chemistry
Chapters)
°
EPA
Registration
No.
4816­
270
(97.5%)
is
no
longer
active;
it
was
transferred
to
EPA
Registration
No.
432­
982
(97.5%),
Aventis
Environmental
Science
USA
LP,
on
February
22,
2000.
°
EPA
Registration
No.
4816­
407
(1%)
is
no
longer
active;
it
was
transferred
to
Reg.
No.
432­
1006
on
February
22,
2000
and
subsequently
transferred
to
Reg.
No.
73049­
238,
Valent
Bioscience
Corporation,
on
June
27,
2001
(neither
4816­
407
or
432­
1006
are
active).
°
As
stated
above,
EPA
Registration
No.
264­
325
(97.5%),
Aventis
CropScience,
should
be
added
to
the
list
of
manufacturing­
use
products.

Agency
Response
To
Aventis
Crop
Science
Comment
5:

The
suggested
modifications
have
been
made
to
the
risk
assessment.

Aventis
Crop
Science
Comment
6:

4.0
Non­
Occupational
Risk
Assessment
and
Characterization
4.2
Dietary
Risk
Assessment
(Page
31;
Paragraph
1;
Lines
3­
5)
EPA
statement:
Carbaryl
is
used
late
in
the
season
at
maximal
seasonal
rates
of
6­
12
lb
ai/
acre.
[Note:
A
Special
Local
Needs
registration
in
California
uses
16
lb
ai/
acre
as
a
maximum
rate
on
citrus.]
6
Aventis'
comment:
The
Section
3
registration
of
carbaryl
products
cover
the
use
on
citrus
at
the
rate
of
5­
16
lbs
ai/
acre
in
the
state
of
California
only.

Agency
Response
To
Aventis
Crop
Science
Comment
6:

The
suggested
modifications
have
been
made
to
the
risk
assessment.

Aventis
Crop
Science
Comment
7:

4.0
Non­
Occupational
Risk
Assessment
and
Characterization
4.3
Estimated
Environmental
Concentrations
in
Water
4.3.1
Environmental
Fate
Characteristics
(Section
4.3.1,
Pages
39­
40)

Aventis'
comment:
The
text
in
section
4.3.1
does
not
include
the
revisions
that
were
made
to
the
EFED
draft
Chapter
and
is
inconsistent.
For
example:
°
on
Page
39,
first
paragraph
of
Section
4.3.1,
first
sentence
"Carbaryl
and
its
degradate
1­
naphthol
are
fairly
mobile
but
are
not
likely
to
persist
or
accumulate
in
the
environment."
°
on
Page
40,
Paragraph
1,
last
sentence
"Carbaryl
is
mobile
to
very
mobile
in
the
environment
(Kf
=
1.7
to
3.2)."

The
information
in
the
EFED
chapter
has
been
revised
to
°
"Carbaryl
is
considered
to
be
moderately
mobile
in
soils"
and
the
Kf
range
is
1.7
to
3.5
(EFED
Chapter,
Page
20
–
Table
3;
Page
22
–
Mobility).
°
"…
literature
information
suggest
that
it
[1­
naphthol]
is
less
persistent
and
less
mobile
than
parent
carbaryl."(
EFED
Chapter,
Page
26,
1­
Naphthol
Fate
and
Transport).

Agency
Response
To
Aventis
Crop
Science
Comment
7:

The
suggested
modifications
have
been
made
to
the
risk
assessment.
7
Aventis
Crop
Science
Comment
8:

4.0
Non­
Occupational
Risk
Assessment
and
Characterization
4.3
Estimated
Environmental
Concentrations
in
Water
4.3.1
Environmental
Fate
Characteristics
(Section
4.3.1,
Paragraphs
2
and
3
(pages
39­
40))

EPA
statement:
In
these
2
paragraphs,
the
chemical
name
for
the
major
carbaryl
degradation
product
is
typed
as
"1­
napthol".

Aventis'
comment:
Correct
spelling
is
"1­
naphthol".

Agency
Response
To
Aventis
Crop
Science
Comment
8:

The
suggested
modifications
have
been
made
to
the
risk
assessment.

Aventis
Crop
Science
Comment
9:

4.0
Non­
Occupational
Risk
Assessment
and
Characterization
4.4
Residential
Risk
Assessment
4.4.2.2
Residential
Handler
Cancer
Risks
(Page
52;
Paragraph
1;
Lines
11­
12)

EPA
statement:
"…[
Note:
Scenarios
where
risks
are
still
of
concern
(i.
e.,
<1x10
­6
)
are
highlighted
in
the
table.].

Aventis'
comment:
(i.
e.,
"<"
1x10
­6
)
should
be
corrected
to
(i.
e.,
">"
1x10
­6
).

Agency
Response
To
Aventis
Crop
Science
Comment
9:

The
suggested
modifications
have
been
made
to
the
risk
assessment.
8
Aventis
Crop
Science
Comment
10:

4.0
Non­
Occupational
Risk
Assessment
and
Characterization
4.4
Residential
Risk
Assessment
4.4.3
Residential
Postapplication
Risk
Assessment
(Page
59;
Paragraph
1;
Lines
4­
6)

EPA
statement:
These
levels
were
The
Agency
instead
considers
them
a
qualitative
indicator
that
exposures
in
the
general
population
are
likely
to
occur.

Aventis'
comment:
Words
are
missing
from
the
first
part
of
the
sentence.

Agency
Response
To
Aventis
Crop
Science
Comment
10:

The
suggested
modifications
have
been
made
to
the
risk
assessment.

Aventis
Crop
Science
Comment
11:

4.0
Non­
Occupational
Risk
Assessment
and
Characterization
4.4
Residential
Risk
Assessment
4.4.3
Residential
Postapplication
Risk
Assessment
(Page:
59
Paragraph:
2
Lines:
1­
6)

EPA
statement:
Aventis
Crop
Science
is
in
the
process
of
conducting
a
biomonitoring
study
with
children
who
live
in
households
where
carbaryl
has
been
used.
Based
on
discussions
with
Aventis,
the
preliminary
results
indicate
that
levels
at
the
highest
percentiles
of
the
distribution
are
similar
to
those
predicted
in
the
Agency's
turf
risk
assessment
for
toddlers
which
are
intended
to
represent
the
higher
percentiles
of
the
exposure
distribution.
A
more
detailed
analysis
will
be
completed
upon
submission
Aventis'
comment:
The
statement
does
not
accurately
reflect
the
true
scope
of
the
study
and
would
be
misleading.
The
comment
would
be
more
accurate
as
follows:

Aventis
CropScience
has
completed
and
is
in
the
process
of
submitting
to
the
Agency
a
biomonitoring
study
of
individuals
in
residences
following
the
application
by
a
member
of
the
household
to
the
lawn
and
either
the
vegetable
garden
or
ornamental
flowers.
Based
on
discussions
with
Aventis,
preliminary
results
indicate
that
the
highest
percentiles
of
the
distribution
of
the
younger
children
in
the
homes
were
similar
to
those
predicted
in
the
Agency's
turf
risk
assessment
for
toddlers
that
are
intended
to
represent
the
higher
percentiles
of
the
exposure
distribution.
A
more
detailed
analysis
will
be
completed
upon
submission.
9
Agency
Response
To
Aventis
Crop
Science
Comment
11
The
suggested
modifications
have
been
made
to
the
risk
assessment.

Aventis
Crop
Science
Comment
12:

5.0
Aggregate
Risk
Assessments
and
Risk
Characterization
5.1
Calculation
of
Aggregate
Risks
and
DWLOCs
(Page
72;
Paragraph
2;
Lines
6­
11)

EPA
statement:
"Additionally,
acute
dietary
risks
were
also
exceeded
for
infants
and
children
(1
to
6
years
old)
at
the
99.9
th
percentile
when
the
Carbamate
Market
Basket
Survey
(CMBS)
was
not
considered
in
the
assessment.
However,
the
risk
picture
could
substantively
change
if
residential
risks
are
refined
based
on
updated
use
information
from
the
carbaryl
use
survey
yet
to
be
submitted
to
the
Agency
and
the
Agency
chooses
to
regulate
using
the
results
of
the
CMBS."

Aventis'
comment:
This
statement
is
inconsistent
with
information
presented
elsewhere
in
the
HED
Chapter.
As
written,
the
statement
implies
that
the
Agency
has
not
yet
approved
the
use
of
the
CMBS
data
in
the
dietary
risk
assessment
for
carbaryl.
However,
EPA
states
in
the
Hazard
Characterization
section
of
the
Executive
Summary,
page
6,
paragraph
2,
line
9,
"Dietary
exposures
were
calculated
using
FDA
and
PDP
monitoring
data,
a
carbamate
market
basket
survey,
and
…"
which
indicates
that
the
EPA
approved
the
use
of
the
CMBS
data.
In
addition,
it
is
stated
on
pages
8
and
31
(Footnotes)
and
page
37,
first
paragraph:
"At
the
present
time,
information
from
the
industry­
sponsored
Carbamate
Market
Basket
Survey
has
been
approved
for
use
in
dietary
risk
assessments
with
appropriate
characterization
of
uncertainties
associated
with
the
conduct
of
the
study.
Hence,
the
use
of
these
data
in
this
assessment
should
be
considered
with
associated
caveats
…"

Agency
Response
To
Aventis
Crop
Science
Comment
12:

Please
refer
to
the
Agency
response
to
Aventis
Crop
Science
comment
3
above.

Aventis
Crop
Science
Comment
13:

5.0
Aggregate
Risk
Assessments
and
Risk
Characterization
5.7
Summary
of
Aggregate
Risks
(Page
76;
Paragraph
2;
Lines
3­
4
continued
on
page
77)

EPA
statement:
"Additionally,
acute
dietary
risks
were
also
exceeded
for
infants
and
children
(1
to
6
years
old)
at
the
99.9
th
percentile
when
the
Carbamate
Market
Basket
Survey
(CMBS)
was
not
considered
in
the
assessment.
However,
the
risk
picture
10
could
substantively
change
if
residential
risks
are
refined
based
on
updated
use
information
from
the
carbaryl
use
survey
yet
to
be
submitted
to
the
Agency
and
the
Agency
chooses
to
regulate
using
the
results
of
the
CMBS."

Aventis'
comment:
This
statement
is
inconsistent
with
information
presented
elsewhere
in
the
HED
Chapter.
As
written,
the
statement
implies
that
the
Agency
has
not
yet
approved
the
use
of
the
CMBS
data
in
the
dietary
risk
assessment
for
carbaryl.
However,
EPA
states
in
the
Hazard
Characterization
section
of
the
Executive
Summary,
page
6,
paragraph
2,
line
9,
"Dietary
exposures
were
calculated
using
FDA
and
PDP
monitoring
data,
a
carbamate
market
basket
survey,
and
…"
which
indicates
that
the
EPA
approved
the
use
of
the
CMBS
data.
In
addition,
it
is
stated
on
pages
8
and
31
(Footnotes)
and
page
37,
first
paragraph:
"At
the
present
time,
information
from
the
industry­
sponsored
Carbamate
Market
Basket
Survey
has
been
approved
for
use
in
dietary
risk
assessments
with
appropriate
characterization
of
uncertainties
associated
with
the
conduct
of
the
study.
Hence,
the
use
of
these
data
in
this
assessment
should
be
considered
with
associated
caveats
…"

Agency
Response
To
Aventis
Crop
Science
Comment
13:

Please
refer
to
the
Agency
response
to
Aventis
Crop
Science
comment
3
above.

Aventis
Crop
Science
Comment
14:

7.1
Occupational
Handler
Risk
Assessment
(Page:
83;
Paragraph
5;
Lines
9­
10
and
Footnote)

EPA
statement:
There
are
no
data
compensation
issues
with
any
of
these
data.
11
.

(Footnote)
11
Non­
ORETF
data
included
in
MRIDs
451672­
01
and
452507­
01
were
from
studies
submitted
by
Aventis
CropScience.
The
propoxur
trigger
sprayer
study
has
a
signed
PHED
data
waiver
but
has
not
been
included
into
PHED.

Aventis'
comment:
Aventis
concurs
that
there
are
no
data
compensation
issues.
However,
the
rationale
presented
for
the
propoxur
trigger
sprayer
study
is
not
accurate.
The
PHED
data
waiver
is
applicable
only
when
the
data
are
in
PHED
and
not
when
cited
outside
of
PHED.
The
propoxur
study
does
not
trigger
data
compensation
because
the
study
is
the
property
of
Bayer
CropScience
which
has
recently
acquired
Aventis
CropScience.

Agency
Response
To
Aventis
Crop
Science
Comment
14:

The
suggested
modifications
have
been
made
to
the
risk
assessment.
11
Section
2:
Product
and
Residue
Chemistry
This
section
addresses
the
comments
received
from
Aventis
Crop
Science
pertaining
to
the
product
and
residue
chemistry
supporting
document
(D283328).
This
document
has
not
been
altered
at
this
point
to
reflect
the
changes
suggested
by
the
registrant,
Aventis
Crop
Sciences.
Rather,
specific
changes
which
could
impact
the
results
of
the
risk
assessment
were
considered
and
the
appropriate
modifications
were
made
to
the
risk
assessment.
The
Agency
response
to
comments
provided
by
Aventis
will
serve
as
errata
to
the
product
and
residue
chemistry
chapter
(D283328).

Aventis
Crop
Science
Comment
15:

General
several
References
Throughout
the
Document
EPA
statement:
The
company
name
of
the
registrant
is
listed
throughout
the
document
as
Aventis
Ag
Company.

Aventis'
comment:
Reference
should
be
to
Aventis
CropScience.

[Note:
This
issue
was
repeated
in
the
Aventis
Crop
Science
comments
pertaining
to
the
product
and
residue
chemistry
chapters.
It
is
only
addressed
here.]

Agency
Response
To
Aventis
Crop
Science
Comment
15:

The
suggested
modifications
will
be
made
to
the
product
and
residue
chemistry
chapter
(D283328)
if
and
when
the
document
is
reissued.
Otherwise
the
Agency
acknowledges
this
comment
and
has
altered
the
overall
risk
assessment
document
to
reflect
the
suggested
change.

Aventis
Crop
Science
Comment
16:

Product
Chemistry
Chapter/
Manufacturing­
Use
Products
(Page
2;
Table
1
–
Registered
Carbaryl
Manufacturing­
Use
Products)

Aventis'
comment:
°
EPA
Registration
No.
45735­
24
(99%),
Carbaryl
99%
Technical
Grade
Insecticide,
Burlington
Scientific
Corporation,
should
be
added
to
the
list
of
registered
carbaryl
technical.

°
EPA
Registration
No.
4816­
270
(97.5%)
is
no
longer
active;
it
was
transferred
to
EPA
Registration
No.
432­
982
(97.5%),
Aventis
Environmental
Science
USA
LP,
on
February
22,
2000.
12
°
EPA
Registration
No.
4816­
407
(1%)
is
no
longer
active;
it
was
transferred
to
Reg.
No.
432­
1006
on
February
22,
2000
and
subsequently
transferred
to
Reg.
No.
73049­
238,
Valent
Bioscience
Corporation,
on
June
27,
2001
(neither
4816­
407
or
432­
1006
are
active).

°
The
name
of
the
registrant
for
EPA
Registration
No.
769­
971
is
Value
Gardens
Supply,
LLC.

Corresponding
corrections
should
be
made
to
the
Product
Chemistry
Section
of
the
Memorandum
for
this
Chapter
and
in
other
sections
of
the
Product
Chemistry
Chapter
of
the
Reregistration
Eligibility
Decision
(RED)
Document.

Agency
Response
To
Aventis
Crop
Science
Comment
16:

The
suggested
modifications
will
be
made
to
the
product
and
residue
chemistry
chapter
(D283328)
if
and
when
the
document
is
reissued.
Otherwise
the
Agency
acknowledges
this
comment
and
has
altered
the
overall
risk
assessment
document
to
reflect
the
suggested
change.

Aventis
Crop
Science
Comment
17:

Regulatory
Background
(Page
2:
Paragraph
2:
Line
5)

EPA
statement:
"...
but
should
not
delay
on
the
reregistration
eligibility
decisions
for
carbaryl."

Aventis'
comment:
Remove
"on"
from
the
sentence,
"...
but
should
not
delay
on
the
reregistration..."

Agency
Response
To
Aventis
Crop
Science
Comment
17:

The
Agency
is
unclear
about
this
comment
but
will
review
the
affected
text
and
make
appropriate
changes.

Aventis
Crop
Science
Comment
18:

Summary
of
Science
Findings
GLN
860.1200:
Directions
for
Use
(Page
3:
Table
A1.
Carbaryl
EPs
with
Food/
Feed
Uses
Registered
to
Aventis
Ag
Company)

EPA
statement:
EPA
Registration
No.
264­
430
is
listed
on
this
table.

Aventis'
comment:
The
registration
of
Sevin
Brand
Granular
Carbaryl
Insecticide
For
Outdoor
Home
Use,
EPA
Registration
No.
264­
430,
was
transferred
to
Aventis
Environmental
Science,
EPA
Registration
No.
432­
885
on
February
9,
2000.
13
Agency
Response
To
Aventis
Crop
Science
Comment
18:

The
appropriate
changes
to
the
product
and
residue
chemistry
chapter
will
be
made
after
verification
by
the
chemical
review
manager.
There
is
no
anticipated
impact
on
the
results
of
the
risk
assessment.

Aventis
Crop
Science
Comment
19:

GLN
860.1380:
Storage
Stability
Data
­
Plants
(page
6:
Paragraph
1;
Lines
2­
3)

EPA
statement:
Additional
data
are
required
depicting
the
storage
stability
of
carbaryl
per
se
in
an
oilseed,
processed
commodities
of
an
oily
crop,
and
a
dried
fruit
stored
up
to
10
months.

Aventis'
comment:
Inconsistencies
are
noted
between
the
information
presented
in
the
section
"Summary
of
Science
Findings"
and
Table
B.
Residue
Chemistry
Science
Assessments
for
Reregistration
of
Carbaryl
(page
63)

Paragraph
1
of
the
"GLN
860.1380:
Storage
Stability
Data
­
Plants"
section
indicates
the
need
for
storage
stability
data
for
dried
fruit
(in
addition
to
other
items).
Table
B
data
requirements
(page
63
along
with
footnote
#14
on
page
73)
does
not
request
storage
stability
data
for
dried
fruit;
neither
does
the
4
th
paragraph
on
page
6
(GLN
860.1380).

Agency
Response
To
Aventis
Crop
Science
Comment
19:

The
appropriate
modifications
will
be
made
to
the
product
and
residue
chemistry
chapter
(D283328)
if
and
when
the
document
is
reissued.
Otherwise
the
Agency
acknowledges
this
comment
and
has
altered
the
overall
risk
assessment
document
to
reflect
appropriate
changes.

Aventis
Crop
Science
Comment
20:

GLN
860.1500:
Crop
Field
Trials
(Page
7,
paragraph
5)

EPA
statement:
"In
addition,
conclusions
regarding
the
adequacy
of
the
data
for
alfalfa,
apples,
potatoes...
are
contingent
upon
receipt
and
acceptance
of
adequate
supporting
storage
stability
data."

Aventis'
comment:
The
statement
is
inconsistent
with
information
elsewhere
in
the
document.
There
is
no
requirement
for
storage
stability
data
on
apples
in
the
"GLN
860.1380:
Storage
Stability
Data
­
Plants"
section
(page
6)
nor
in
Table
B
(page
63
along
with
footnote
#14
on
pate
73).
14
Agency
Response
To
Aventis
Crop
Science
Comment
20:

The
appropriate
modifications
will
be
made
to
the
product
and
residue
chemistry
chapter
(D283328)
if
and
when
the
document
is
reissued.
Otherwise
the
Agency
acknowledges
this
comment
and
has
altered
the
overall
risk
assessment
document
to
reflect
appropriate
changes.

Aventis
Crop
Science
Comment
21:

GLN
860.1500:
Crop
Field
Trials
(Page
8,
paragraph
14,
Line
4)

EPA
statement:
"However,
additional
residue
data
are
required
if
the
registrant
seeks
tolerances
for
residues
in/
on
succulent,
shelled
pea
and
bean
commodities."
(Also
stated
in
the
Memorandum
on
page
3,
paragraph
3).

Aventis'
comment:
This
statement
is
in
contradiction
with
paragraph
6
of
this
section:
"...
adequate
magnitude
of
the
residue
data
are
available
on
the
following
crops:
...
beans
(dried
and
succulent),
...
peas
(dried
and
succulent..."
and
Table
B
requirements
for
crop
field
trials
(page
65).
Also,
MRID
43984701
(succulent
bean)
and
MRID
43703102
(fresh
pea)
were
found
to
be
acceptable.

Agency
Response
To
Aventis
Crop
Science
Comment
21:

The
appropriate
modifications
will
be
made
to
the
product
and
residue
chemistry
chapter
(D283328)
if
and
when
the
document
is
reissued
after
verification
by
the
chemical
review
manager.
There
is
no
anticipated
impact
on
the
results
of
the
risk
assessment.

Aventis
Crop
Science
Comment
22:

GLN
860.1520:
Processed
Food/
Feed
(page
9,
paragraph
1,
lines
4­
6)

EPA
statement:
Based
on
the
available
processing
studies,
tolerances
are
required
for
residues
in
citrus
fruit
oil,
raisins,
wet
apple
pomace,
and
rice
hulls
only.

Aventis'
comment:
EPA
requests
processed
commodity
tolerances
for
(among
other
commodities)
wet
apple
pomace
and
raisins
(see
also
Table
C,
page
85).
Calculations
according
to
the
860.1520
Guidelines
indicate
that
processed
commodity
tolerances
are
not
needed
for
these
commodities.
The
Agency's
statement
appears
to
be
the
result
of
a
mathematical
or
computational
type
error
since
the
860.1520
Guidelines
are
rather
clear
on
determination
of
need
for
processed
commodity
tolerances.
15
Agency
Response
To
Aventis
Crop
Science
Comment
22:

The
appropriate
modifications
will
be
made
to
the
product
and
residue
chemistry
chapter
(D283328)
if
and
when
the
document
is
reissued.
Otherwise
the
Agency
acknowledges
this
comment
and
has
altered
the
overall
risk
assessment
document
to
reflect
appropriate
changes.

Aventis
Crop
Science
Comment
23:

GLN
860.1480:
Meat,
Milk,
Poultry,
Eggs
(page
11:
paragraph
3,
line
5)

EPA
statement:
"The
calculation
of
the
maximum
dietary
is
tentative..."

Aventis'
comment:
Add
the
word
"burden"
to
the
statement
"The
calculation
of
the
maximum
dietary
(burden)
is
tentative...".

Agency
Response
To
Aventis
Crop
Science
Comment
23:

The
Agency
will
add
the
word
"burden"
to
the
text
of
the
document.

Aventis
Crop
Science
Comment
24:

GLN
860.1480:
Meat,
Milk,
Poultry,
Eggs
(page
11:
paragraph
4,
lines
1­
2)

EPA
statement:
"...
tolerances
for
residues
of
carbaryl
per
se
in
livestock
(excluding
swine)
commodities
should
be
reassessed..."

Aventis'
comment:
The
tolerance
expression
in
GLN
860.1480
should
be
modified
to
agree
with
the
one
in
GLN
860.1300
(page
4):
"...
tolerances
for
ruminant
meat
and
milk
should
be
expressed
as
residues
of
free
and
conjugated
carbaryl,
5,6­
dihydro­
5,6­
dihydroxy
carbaryl,
and
5­
methoxy­
6­
hydroxy
carbaryl."

Agency
Response
To
Aventis
Crop
Science
Comment
24:

The
appropriate
modifications
will
be
made
to
the
product
and
residue
chemistry
chapter
(D283328)
if
and
when
the
document
is
reissued.
Otherwise
the
Agency
acknowledges
this
comment
and
has
altered
the
overall
risk
assessment
document
to
reflect
appropriate
changes.
16
Aventis
Crop
Science
Comment
25:

Tolerance
Reassessment
Summary,
Table
C.
Tolerance
Reassessment
Summary
For
Carbaryl,
Tolerance
Listed
Under
40
CFR
§180.169
(a),
page
79
Aventis'
comment:
Under
the
commodity
"Corn,
forage",
Comments
on
"Corn,
sweet,
forage":
should
read
"Residue
data
indicate
that
the
tolerance
for
sweet
corn
forage
should
be
increased."
(i.
e.,
replace
"field"
with
"sweet"
in
the
sentence).

Agency
Response
To
Aventis
Crop
Science
Comment
25:

The
appropriate
modifications
will
be
made
to
the
product
and
residue
chemistry
chapter
(D283328)
if
and
when
the
document
is
reissued.
Otherwise
the
Agency
acknowledges
this
comment
and
has
altered
the
overall
risk
assessment
document
to
reflect
appropriate
changes.
17
Section
3:
Occupational
&
Residential
Exposure
This
section
addresses
the
comments
received
from
Aventis
Crop
Science
pertaining
to
the
occupational
and
residential
exposure
supporting
document
(D281418).
This
document
has
not
been
altered
at
this
point
to
reflect
the
changes
suggested
by
the
registrant,
Aventis
Crop
Sciences.
Rather,
specific
changes
which
could
impact
the
results
of
the
risk
assessment
were
considered
and
the
appropriate
modifications
were
made
to
the
risk
assessment.
The
Agency
response
to
comments
provided
by
Aventis
will
serve
as
errata
to
the
occupational
and
residential
exposure/
risk
assessment
chapter
(D281418).

Aventis
Crop
Science
Comment
26:

General,
Several
References
Throughout
the
Document
EPA
statement:
The
company
name
of
the
registrant
is
listed
throughout
the
document
as
Aventis
Corporation
and
Aventis
Crop
Science.

Aventis'
comment:
Reference
should
either
to
Aventis
or
Aventis
CropScience.

Agency
Response
To
Aventis
Crop
Science
Comment
26:

The
suggested
modifications
will
be
made
to
the
occupational
and
residential
exposure
chapter
(D281418)
if
and
when
the
document
is
reissued.
Otherwise
the
Agency
acknowledges
this
comment
and
has
altered
the
overall
risk
assessment
document
to
reflect
the
suggested
change.

Aventis
Crop
Science
Comment
27:

Executive
Summary
(Page
10,
paragraph:
3,
Lines
16­
20)

EPA
comment:
[Note:
The
Aventis
Corporation
is
in
the
process
of
conducting
a
biomonitoring
study
with
children
who
live
in
households
where
carbaryl
has
been
used.
Preliminary
results
indicate
that
levels
at
the
highest
percentiles
of
the
distribution
were
similar
to
those
predicted
in
the
Agency's
turf
risk
assessment
for
toddlers
which
are
intended
to
represent
the
higher
percentiles
of
the
exposure
distribution.
A
more
detailed
analysis
will
be
completed
upon
submission.]

Aventis's
response:
The
statement
does
not
accurately
reflect
the
true
scope
of
the
study
and
would
be
misleading.
The
comment
would
be
more
accurate
as
follows:

Aventis
Crop
Science
has
completed
and
is
in
the
process
of
submitting
to
the
Agency
a
biomonitoring
study
of
individuals
in
residences
following
the
application
by
a
member
of
the
household
to
the
lawn
and
either
the
vegetable
garden
or
ornamental
18
flowers.
Preliminary
results
indicate
that
the
highest
percentiles
of
the
distribution
of
the
younger
children
in
the
homes
were
similar
to
those
predicted
in
the
Agency's
turf
risk
assessment
for
toddlers
that
are
intended
to
represent
the
higher
percentiles
of
the
exposure
distribution.
A
more
detailed
analysis
will
be
completed
upon
submission.

Agency
Response
To
Aventis
Crop
Science
Comment
27:

The
suggested
modifications
will
be
made
to
the
occupational
and
residential
exposure
chapter
(D281418)
if
and
when
the
document
is
reissued.
Otherwise
the
Agency
acknowledges
this
comment
and
has
altered
the
overall
risk
assessment
document
to
reflect
the
suggested
change.

Aventis
Crop
Science
Comment
28:

1.0
Occupational
and
Residential
Exposure/
Risk
Assessment
1.5
Summary
of
Use
Patterns
and
Formulations
1.5.1
End­
Use
Products
(page
15,
table
2)

Aventis'
comment:
Carbaryl
–
Technical
Products
°
EPA
Registration
No.
45735­
24
(99%),
Carbaryl
99%
Technical
Grade
Insecticide,
Burlington
Scientific
Corporation,
should
be
added
to
the
list
of
registered
carbaryl
technical.
°
EPA
Registration
No.
264­
325
(97.5%),
Aventis
CropScience,
should
be
included
in
the
list
of
manufacturing­
use
products.

Carbaryl
–
Manufacturing­
Use
Products
°
EPA
Registration
No.
5481­
190
(46%
FI),
AMVAC
Chemical
corporation
,
is
an
active
registration
and
should
be
added
to
the
list
of
Manufacturing­
Use
Products.
(It
is
listed
in
Table
1,
page
2,
of
the
Product
and
Residue
Chemistry
Chapters)
°
EPA
Registration
No.
4816­
270
(97.5%)
is
no
longer
active;
it
was
transferred
to
EPA
Registration
No.
432­
982
(97.5%),
Aventis
Environmental
Science
USA
LP,
on
February
22,
2000.
°
EPA
Registration
No.
4816­
407
(1%)
is
no
longer
active;
it
was
transferred
to
Reg.
No.
432­
1006
on
February
22,
2000
and
subsequently
transferred
to
Reg.
No.
73049­
238,
Valent
Bioscience
Corporation,
on
June
27,
2001
(neither
4816­
407
or
432­
1006
are
active).
°
As
stated
above,
EPA
Registration
No.
264­
325
(97.5%),
Aventis
CropScience,
should
be
added
to
the
list
of
manufacturing­
use
products.
19
Agency
Response
To
Aventis
Crop
Science
Comment
28:

The
suggested
modifications
will
be
made
to
the
occupational
and
residential
exposure
chapter
(D281418)
if
and
when
the
document
is
reissued
pending
verification
by
the
chemical
review
manager.
Otherwise
the
Agency
acknowledges
this
comment
and
has
altered
the
overall
risk
assessment
document
to
reflect
the
suggested
change.
[Note:
This
comment
was
also
addressed
above
in
the
risk
assessment
section.]

Aventis
Crop
Science
Comment
29:

1.5.3
Registered
Use
Categories
and
Sites
(page
20,
animal
uses)

EPA
statement:

Poultry
(Chickens,
ducks,
geese,
game
birds,
turkeys)
Livestock
(cattle,
sheep,
horses,
etc.)

Aventis'
comment:
Both
uses
should
be
removed
from
the
list
of
registered
uses.
Aventis
voluntarily
requested
the
deletion
of
the
use
on
poultry.
A
Federal
Register
Notice
dated
October
24,
2001
announced
receipt
by
the
Agency
of
an
application
from
Aventis
Crop
Science
to
delete
this
use.
The
use
on
livestock
(cattle,
sheep,
horses,
etc.)
is
no
longer
registered.
Aventis
will
not
support
the
reregistration
of
this
use.

Agency
Response
To
Aventis
Crop
Science
Comment
29:

The
suggested
modifications
will
be
made
to
the
occupational
and
residential
exposure
chapter
(D281418)
if
and
when
the
document
is
reissued
once
the
suggested
changes
are
verified
by
the
chemical
review
manager.
It
should
be
noted
that
an
August
1,
2002
review
of
the
Agency's
REFs
system
still
had
active
registrations
listed
for
both
poultry
and
unspecified
livestock
and
horses.
There
were
some
registrations
for
cattle
that
were
listed
as
inactive.

Aventis
Crop
Science
Comment
30:

1.5.3
Registered
Use
Categories
and
Sites
(page
21,
aquatic
food
crop)

EPA
statement:
Aquatic
sites
­
commercial
fishery
water
systems
Aventis'
comment:
This
use
is
not
listed
on
Aventis
Carbaryl
product
labels.
20
Agency
Response
To
Aventis
Crop
Science
Comment
30:

The
use
likely
attributed
to
this
site
is
from
EPA
Reg.
No.
264­
316,
SLN
WA­
900013
which
is
for
Sevin
Brand
80S
Carbaryl
Insecticide
For
Control
Of
Ghost
and
Mud
Shrimp
in
Oyster
Beds
in
Washington
state.

Aventis
Crop
Science
Comment
31:

1.5.3
Registered
Use
Categories
and
Sites
(page
21,
aquatic
non­
food
industrial)

EPA
statement:
Aquatic
sites
­
drainage
systems
Aventis'
comment:
This
use
is
not
listed
on
Aventis
carbaryl
products
labels.

Agency
Response
To
Aventis
Crop
Science
Comment
31:

The
suggested
modifications
will
be
made
to
the
occupational
and
residential
exposure
chapter
(D281418)
if
and
when
the
document
is
reissued
once
the
suggested
changes
are
verified
by
the
chemical
review
manager
and
another
review
of
available
labels
is
completed.
It
should
be
noted
that
an
August
1,
2002
review
of
the
Agency's
REFs
system
still
had
an
active
registration
for
this
site.

Aventis
Crop
Science
Comment
32:

2.0
Occupational
Exposures
and
Risks
2.1
Occupational
Handler
Exposures
and
Risks
2.1.2
Data
and
Assumptions
For
Handler
Exposure
Scenarios
(page
36,
paragraph
1,
lines
1
­
4)

EPA
statement:
There
are
no
data
compensation
issues
associated
with
the
use
of
nonORETF
data...
and
the
propoxur
trigger
sprayer
study
has
a
signed
PHED
data
waiver
but
just
has
not
been
included
into
PHED
at
this
time.

Aventis'
response:
Aventis
concurs
that
there
are
no
data
compensation
issues.
However,
the
rationale
for
the
propoxur
trigger
sprayer
study
is
not
correct.
The
PHED
data
waiver
is
applicable
only
when
the
data
are
in
PHED
and
not
when
cited
outside
of
PHED.
The
propoxur
study
does
not
trigger
data
compensation
because
the
study
is
the
property
of
Bayer
Crop
Science
which
has
acquired
Aventis
Crop
Science.
21
Agency
Response
To
Aventis
Crop
Science
Comment
32:

The
suggested
modifications
will
be
made
to
the
occupational
and
residential
exposure
chapter
(D281418)
if
and
when
the
document
is
reissued.
Otherwise
the
Agency
acknowledges
this
comment
and
has
altered
the
overall
risk
assessment
document
to
reflect
the
suggested
change.
[Note:
This
comment
was
also
addressed
above
in
the
risk
assessment
section.]

Aventis
Crop
Science
Comment
33:

3.0
Residential
and
Other
Non­
Occupational
Exposures
and
Risks
3.1
Residential
Handler
Exposures
and
Risks
3.1.2
Data
and
Assumptions
For
Handler
Exposure
Scenarios
(page
99,
paragraph:
2,
line
9)

EPA
statement:
"Longitudinal
data,
however,
were
not
available
to
establish
that
such
populations
definitively
exist."

Aventis'
comment:
The
following
should
be
added
after
this
sentence
to
accurately
reflect
the
submission
of
Residential
Exposure
Joint
Venture
data
for
carbaryl
that
covers
use
patterns
by
the
same
individuals
between
May
and
August.

"Note:
Aventis
has
recently
submitted
an
analysis
of
longitudinal
residential
use
patterns
of
carbaryl
that
monitored
the
use
of
carbaryl
within
several
thousand
households
between
the
months
of
May
through
August."

Agency
Response
To
Aventis
Crop
Science
Comment
33:

At
the
time
the
occupational
and
residential
exposure/
risk
assessment
was
completed,
the
Residential
Exposure
Joint
Venture
data
for
carbaryl
had
not
yet
been
submitted
by
Aventis
Crop
Science.
The
Agency
will
review
this
information,
both
in
the
context
of
a
deterministic
and
a
probabilistic
risk
assessment
strategy.
Results
from
this
study
will
be
incorporated
into
any
revisions
to
the
human
health
risk
assessment
and
the
occupational
and
residential
exposure/
risk
assessment
documents
as
appropriate.
22
Aventis
Crop
Science
Comment
34:

3.0
Residential
and
Other
Non­
Occupational
Exposures
and
Risks
3.1
Residential
Handler
Exposures
and
Risks
3.1.2
Data
and
Assumptions
For
Handler
Exposure
Scenarios
(pages
104­
105,
Discussion
of
OMA004)

EPA
statement:
The
discussion
presents
exposure
data
for
Dial­
type
(DTS)
Homeowner
Hose­
End
sprayers
and
Ready­
to­
Use
Sprayers.
However,
Table
23
and
subsequent
risk
and
exposure
tables
only
present
exposure
estimates
based
on
the
DTS
sprayer.

Aventis'
response:
The
RTU
sprayer
is
an
important
component
of
the
carbaryl
market
and
was
developed
as
an
exposure
mitigation
product
that
eliminates
the
homeowner's
need
to
pour
concentrated
formulations
of
carbaryl.
The
OMA004
study
demonstrated
significant
reductions
in
the
exposure
to
homeowners
and
the
presentation
of
the
resultant
RTU
hose­
end
sprayer
data,
exposure,
and
risk
is
essential
to
the
residential
handler
section.

Agency
Response
To
Aventis
Crop
Science
Comment
34:

The
Agency
did
not
include
a
quantitative
analysis
based
on
the
ready­
to­
use
(no
mixing/
loading)
product
because
it
is
unclear
if
the
packaging
used
in
the
study
is
similar
to
the
containers
used
for
carbaryl
and
it
is
also
not
clear
what
percentage
of
the
market
for
carbaryl
is
accounted
for
by
the
no­
mix
containers.
The
Agency
calculated
risk
estimates
based
solely
on
the
hose­
end
sprayer
data
that
required
users
to
add
concentrated
formulation
to
the
device.
Both
sets
of
information
will
be
considered
in
any
risk
management
decision.
The
Agency
used
the
following
unit
exposures
in
its
assessment
(i.
e.,
the
open
mixing
data
from
ORETF
Study
OMA004):

°
Dermal
geo.
mean
for
a
person
wearing
shorts
and
a
short­
sleeved
shirt:
11
mg/
lb
ai
°
Inhalation
geo.
mean
for
a
person
not
wearing
a
respirator:
16
µg/
lb
ai
[Dermal
exposure
drives
the
overall
risk
estimate
so
any
change
in
dermal
exposure
would
clearly
and
proportionally
alter
the
overall
risk
estimate.
The
total
MOE
(includes
both
dermal
and
inhalation
exposures)
for
broadcast
applications
to
lawns
is
25
while
the
MOE
for
spot
treatments
is
495
(Agency
target
is
100).]

The
unit
exposure
values
from
ORETF
Study
OMA004
where
no
mixing
dial
type
sprayers
were
used
are
as
follows:

°
Dermal
geo.
mean
for
a
person
wearing
shorts
and
a
short­
sleeved
shirt:
2.6
mg/
lb
ai
°
Inhalation
geo.
mean
for
a
person
not
wearing
a
respirator:
11
µg/
lb
ai
23
If
the
MOE
for
broadcast
applications
is
adjusted
for
changes
in
the
dermal
exposure
estimate,
then
the
MOE
would
be
~106
(25*
11/
2.6)
which
exceeds
Agency
targets.
This
information
will
be
considered
in
the
risk
management
decisions
as
well
as
the
feasability
of
using
the
no­
mix
containers
in
100
percent
of
the
carbaryl
market.

Aventis
Crop
Science
Comment
35:

3.2
Residential
Postapplication
Exposures
and
Risks
3.2.2
Data
and
Assumptions
For
Residential
Postapplication
Exposure
Scenarios
(Page:
122
Paragraph:
5
Lines:
1­
6)

EPA
statement:
Aventis
Crop
Science
is
in
the
process
of
conducting
a
biomonitoring
study
with
children
who
live
in
households
where
carbaryl
has
been
used.
Preliminary
results
indicate
that
levels
at
the
highest
percentiles
of
the
distribution
were
similar
to
those
predicted
in
the
Agency's
turf
risk
assessment
for
toddlers
which
are
intended
to
represent
the
higher
percentiles
of
the
exposure
distribution.
A
more
detailed
analysis
will
be
completed
upon
submission
Aventis'
comment:
The
statement
does
not
accurately
reflect
the
true
scope
of
the
study
and
would
be
misleading.
The
comment
would
be
more
accurate
as
follows:

Aventis
CropScience
has
completed
and
is
in
the
process
of
submitting
to
the
Agency
a
biomonitoring
study
of
individuals
in
residences
following
the
application
by
a
member
of
the
household
to
the
lawn
and
either
the
vegetable
garden
or
ornamental
flowers.
Preliminary
results
indicate
that
the
highest
percentiles
of
the
distribution
of
the
younger
children
in
the
homes
were
similar
to
those
predicted
in
the
Agency's
turf
risk
assessment
for
toddlers
that
are
intended
to
represent
the
higher
percentiles
of
the
exposure
distribution.
A
more
detailed
analysis
will
be
completed
upon
submission.

Agency
Response
To
Aventis
Crop
Science
Comment
35:

The
suggested
modifications
have
been
made
to
the
risk
assessment.

Aventis
Crop
Science
Comment
36:

3.2.4
Residential
Postapplication
Exposure
and
Noncancer
Risk
Estimates
(page
132
and
135,
Tables
26
and
28)

EPA
comment:
The
residential
turf
(lawncare)
scenario
does
not
differentiate
between
liquid
spray
and
granular
formulation
applications.
24
Aventis'
response:
There
is
significant
differences
in
the
postapplication
exposure
potential
following
a
liquid
spray
application
compared
to
a
granular
application.
ORETF
data
submitted
to
the
Agency
indicate
that
transferable
residues
following
a
granular
application
are
about
10
times
less
than
a
liquid
spray
application
.
In
addition,
ORETF
has
recently
conducted
a
large
postapplication
exposure
study
in
Moses
Lake,
Washington
that
will
provide
both
adult
Jazzercise
and
Children's
Activity
Pattern
(CHAPs)
transfer
coefficients.
Although
the
Moses
Lake
data
have
not
yet
been
submitted,
the
conduct
of
the
study
should
be
referenced
and
the
tables
should
differentiate
between
the
very
different
liquid
spray
and
granular
lawn
postapplication
exposure
scenarios.

Agency
Response
To
Aventis
Crop
Science
Comment
36:

The
Agency
acknowledges
this
comment
and
will
incorporate
data
from
this
study
as
appropriate
in
the
risk
assessment
and
risk
management
process.
It
should
be
noted
that
even
there
appears
to
be
differences
between
TTR
(turf
transferable
residues)
levels
after
liquid
or
granular
formulation
applications,
Aventis
Crop
Science
only
completed
a
TTR
study
using
a
liquid
formulation
of
carbaryl.
