July
18,
2002
Mr.
Anthony
Britten,
SRRD
Document
Processing
Desk
(7504C)
Office
of
Pesticide
Programs
U.
S.
Environmental
Protection
Agency
Room
266A,
Crystal
Mall
2
1921
Jefferson
Davis
Highway
Arlington,
Virginia
22202
Dear
Mr.
Britten,

Re:
Carbaryl;
Chemical
number
56801;
EPA
Reg.
No.
264­
324
Error
Correction
of
Carbaryl
Risk
Assessments
Attached
are
our
comments
on
the
error
correction
review
of
the
revised
HED
and
EFED
Risk
Assessments
for
Carbaryl.
We
have
also
included
some
comments
on
certain
supporting
documents
for
the
HED
Chapter.

One
issue
of
concern
was
noted
during
our
review
of
the
risk
assessments.
It
appears
that
the
Agency
intends
to
include
the
Data
Evaluation
Records
(DERs)
for
a
number
of
carbaryl
studies
in
the
draft
EFED
Chapter
which
will
be
made
available
to
the
public
for
the
60­
day
comment
period.
We
believe
that
it
is
inappropriate
to
include
the
DERs
in
the
RED
document.
A
sufficiently
detailed
summary
of
study
findings
is
already
provided
in
the
EFED
Chapter.
The
summary
of
endpoints
that
is
included
in
the
draft
Carbaryl
EFED
Chapter
is
typical
of
other
Draft
EFED
REDs
that
have
been
issued
recently
and
provides
sufficient
information
to
allow
the
reader
to
determine
the
endpoints
that
were
selected
for
modeling
and
the
justification
for
their
selection.
The
inclusion
of
the
more
detailed
information
present
in
the
DERs
is
unnecessary.

We
have
reviewed
the
dockets
for
many
of
the
RED
documents
that
have
recently
been
issued
(many
other
insecticides
and
several
fungicides)
and
none
of
them
include
DERs
in
any
of
the
preliminary
Environmental
Fate
and
Effects
Assessments.
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.
The
inclusion
of
the
DERs
in
the
docket
that
is
publicly
available
circumvents
this
process
and
is
a
departure
from
the
procedures
that
have
been
followed
until
now
by
the
Agency.
It
is
unclear
why
the
Agency
chose
to
change
their
policy
for
only
certain
DERs
for
a
single
product
when
adequate
summary
information
is
already
provided
in
the
text
of
the
Carbaryl
EFED
Chapter.

This
issue
deserves
careful
consideration
before
the
Agency
makes
the
decision
to
amend
their
existing
policy
on
providing
this
type
of
information
to
the
public.
Your
help
in
ensuring
that
July
12,
2002
Mr.
Anthony
Britten
Page
2
of
2
accepted
procedures
are
followed
for
the
public
review
of
the
Carbaryl
RED
Chapters
is
greatly
appreciated.

Sincerely,

Danielle
A.
Larochelle
Registration
Manager
Corr.
#
daL018­
02
CARBARYL
PC
Code
No.
056801;
Case
0080
Human
Health
Risk
Assessment
and
Supporting
Documents
–
Phase
1
Error
Correction
–
July
12,
2002
Aventis
CropScience
P.
O.
Box
12014,
2
T.
W.
Alexander
Drive
Research
Triangle
Park,
NC
27709
CARBARYL
Human
Health
Risk
Assessment
and
Supporting
Documents
­
Phase
1
Error
Correction
TABLE
OF
CONTENTS
TABLE
OF
CONTENTS
................................................................................................................
2
HUMAN
HEALTH
RISK
ASSESSMENT,
JUNE
7,
2002............................................................
3
General.....................................................................................................................................
3
1.0
Executive
Summary..........................................................................................................
3
Dietary
Risk
Estimates....................................................................................................
3
Aggregate
Risks
and
DWLOCs......................................................................................
3
Issues
for
Considerations
................................................................................................
4
4.0
Non­
Occupational
Risk
Assessment
and
Characterization...............................................
4
4.1
Summary
of
Registered
Uses...................................................................................
4
4.2
Dietary
Risk
Assessment
.........................................................................................
5
4.3
Estimated
Environmental
Concentrations
in
Water.........................................
5
4.3.1
Environmental
Fate
Characteristics
.......................................................
5
4.4
Residential
Risk
Assessment
...........................................................................
6
4.4.2.2
Residential
Handler
Cancer
Risks
......................................................
6
4.4.3
Residential
Postapplication
Risk
Assessment........................................
6
5.0
Aggregate
Risk
Assessments
and
Risk
Characterization..................................................
7
5.1
Calculation
of
Aggregate
Risks
and
DWLOCs.......................................................
7
5.7
Summary
of
Aggregate
Risks
..................................................................................
7
7.1
Occupational
Handler
Risk
Assessment
..................................................................
8
REVISED
PRODUCT
AND
RESIDUE
CHEMISTRY
CHAPTERS
FOR
THE
REREGISTRATION
ELIGIBILITY
DECISION;
MAY
30,
2002........................................
9
General.....................................................................................................................................
9
Product
Chemistry
Chapter
of
the
RED
Document.................................................................
9
Manufacturing­
Use
Products
..........................................................................................
9
Residue
Chemistry
Chapter
of
the
RED
Document
................................................................
9
Regulatory
Background
................................................................................................
10
Summary
of
Science
Findings
......................................................................................
10
GLN
860.1200:
Directions
for
Use...............................................................
10
GLN
860.1380:
Storage
Stability
Data
­
Plants............................................
10
GLN
860.1500:
Crop
Field
Trials.................................................................
10
GLN
860.1520:
Processed
Food/
Feed
..........................................................
11
GLN
860.1480:
Meat,
Milk,
Poultry,
Eggs
..................................................
11
Tolerance
Reassessment
Summary...............................................................................
12
Table
C.
Tolerance
Reassessment
Summary
for
Carbaryl
...........................
12
Miscellaneous
Typographical
Errors
............................................................................
12
3
Human
Health
Risk
Assessment,
June
7,
2002
General
Several
References
Throughout
the
Document
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.

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
….".

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
4
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
…"

Issues
for
Considerations
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
for
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."

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.
5
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.

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.]
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.

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).
6
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".

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
).

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.

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
7
intended
to
represent
the
higher
percentiles
of
the
exposure
distribution.
A
more
detailed
analysis
will
be
completed
upon
submission.

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
…"

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
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,
8
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
…"

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.
9
Revised
Product
and
Residue
chemistry
Chapters
for
the
Reregistration
Eligibility
Decision;
May
30,
2002
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.

Product
Chemistry
Chapter
of
the
RED
Document
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.

¨
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.

Residue
Chemistry
Chapter
of
the
RED
Document
Several
References
Throughout
the
Document
EPA
statement:
The
company
name
of
the
registrant
is
listed
throughout
the
document
as
Aventis
Ag
Company,
Aventis
Ag
Co.,
and
Aventis
Crop
Science.

Aventis'
comment:
Reference
should
be
to
Aventis
CropScience.
10
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
…"

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
in
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.

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
for
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).

GLN
860.1500:
Crop
Field
Trials
Page
7;
Paragraph
5
EPA
statement:
11
"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
page
73).

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.

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
indicates
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.

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
...".
12
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."

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
sentence).

Miscellaneous
Typographical
Errors
­
Under
"REGULATORY
BACKGROUND",
paragraph
3
of
section,
line
5
(page
2):
remove
"on"
from
the
sentence
"...
should
not
delay
on
the
reregistration
...".

­
Under
"SUMMARY
OF
SCIENCE
FINDINGS,
GLN
860.1500:
Crop
Field
Trials",
paragraph
4,
line
5,
page
7:
remove
period
(.)
after
"ppm"
in
"...
current
tolerance
of
10
ppm.
and
all
residue
data
...".
Also
in
memorandum,
page
3,
paragraph
1.

­
Under
"SUMMARY
OF
SCIENCE
FINDINGS,
GLN
860.1520:
Processed
Food/
Feed",
paragraph
2,
line
2
(page
9):
add
"to"
to
the
statement
"...
when
this
concentration
factor
is
applied
(to)
the
HAFT
residue
...".

­
Footnotes
to
Table
B.
Residue
Chemistry
Science
Assessment
for
Reregistration
of
Carbaryl:
#38:
correct
the
spelling
of
"canceled".

­
Table
C.
Tolerance
Reassessment
Summary
of
Carbaryl,
under
the
commodity
"Sorghum,
stover"
(under
"Comments":
correct
spelling
of
sorghum).
CARBARYL
PC
Code
No.
056801;
Case
0080
Revised
EFED
Risk
Assessment
of
Carbaryl
in
Support
of
the
Reregistration
Eligibility
Decision
(RED)

–
Phase
1
Error
Correction
–
July
12,
2002
Aventis
CropScience
P.
O.
Box
12014,
2
T.
W.
Alexander
Drive
Research
Triangle
Park,
NC
27709
CARBARYL
Revised
EFED
Risk
Assessment
of
Carbaryl
in
Support
of
the
Reregistration
Eligibility
Decision
(RED)

­
Phase
1
Error
Correction
TABLE
OF
CONTENTS
TABLE
OF
CONTENTS
................................................................................................................
2
ENVIRONMENTAL
FATE
AND
ECOLOGICAL
RISK
ASSESSMENT
FOR
THE
REREGISTRATION
OF
CARBARYL..................................................................................
3
General.....................................................................................................................................
3
1.0
Summary
and
Environmental
Risk
Conclusions
..............................................................
3
Fate
and
Water
Assessment
............................................................................................
3
3.0
Integrated
Risk
Characterization.......................................................................................
3
Introduction.....................................................................................................................
3
4.0
Environmental
Fate
Assessment
.......................................................................................
4
Exposure
Characterization..............................................................................................
4
5.0
Drinking
Water
Assessment
.............................................................................................
5
Drinking
Water
Modeling...............................................................................................
5
Appendix
D:
Toxicity
Assessment
.........................................................................................
5
Toxicity
to
Terrestrial
Animals.......................................................................................
5
3
Environmental
Fate
and
Ecological
Risk
Assessment
for
the
Reregistration
of
Carbaryl
General
Several
References
Throughout
the
Document
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.

1.0
Summary
and
Environmental
Risk
Conclusions
Fate
and
Water
Assessment
Page:
4
Paragraph:
1
Line:
16
EPA
statement:
…to
those
reported
n
non­
targeted…
Aventis'
comment:
extra
"n"
in
sentence
3.0
Integrated
Risk
Characterization
Introduction
Page:
8
Paragraph:
1
Line:
8
EPA
statement:
alkaline
(pH
half­
life
=
5
hours
environments.
Aventis'
comment:
alkaline
(pH
half­
life
=
3.2
hours)
environments.

half­
life
is
3.2
not
5
hours
as
noted
elsewhere
in
the
document.
Missing
closing
parenthesis.
4
4.0
Environmental
Fate
Assessment
Exposure
Characterization
Page:
17
Paragraph:
3
Line:
last
sentence
EPA
statement:
Detailed
discussion
and
reviews
(DERs)
of
the
studies
that
are
included
in
this
assessment
are
attached
in
Appendix
A.
Aventis'
comment:
It
is
inappropriate
to
include
the
DERs
in
the
RED.
A
sufficiently
detailed
summary
of
study
findings
is
already
included
in
the
EFED
Chapter.
The
summary
of
endpoints
that
is
included
in
the
draft
Carbaryl
EFED
Chapter
is
typical
of
other
Draft
EFED
REDs
that
have
been
issued
recently
and
provides
sufficient
information
to
allow
the
reader
to
determine
the
endpoints
that
were
selected
for
modeling
and
the
justification
for
their
selection.
The
inclusion
of
the
more
detailed
information
present
in
the
DERs
is
unnecessary.

We
have
reviewed
the
dockets
for
many
of
the
RED
documents
that
have
recently
been
issued
(many
other
insecticides
and
several
fungicides)
and
none
of
them
include
DERs
in
any
of
the
preliminary
Environmental
Fate
and
Effects
Assessments.
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.
The
inclusion
of
the
DERs
in
the
docket
that
is
publicly
available
circumvents
this
process
and
is
a
departure
from
the
procedures
that
have
been
followed
until
now
by
the
Agency.
It
is
unclear
why
the
Agency
chose
to
change
their
policy
for
only
certain
DERs
for
a
single
product
when
adequate
summary
information
is
already
provided
in
the
text
of
the
Carbaryl
EFED
Chapter.

Page:
17
Paragraph:
4
Line:
4
EPA
statement:
lower
levels
(generally
less
than
0.01
µ/
L).
Aventis'
comment:
value
missing
units
­
(generally
less
than
0.01
µg/
L).

Persistence
Microbially­
Mediated
Processes
Page:
22
Paragraph:
2
Line:
1
EPA
statement:
A
number
of
soil
microorganisms
5
Aventis'
comment:
"microorga
nisms"

5.0
Drinking
Water
Assessment
Drinking
Water
Modeling
Page:
33
Table
6
EPA
statement:
Crop
name
–
Sugar
Beats
(MN)
Aventis'
comment:
Correct
spelling
is
Sugar
Beets
Appendix
D:
Toxicity
Assessment
Toxicity
to
Terrestrial
Animals
Mammals,
Acute
and
Chronic
Page:
237
above
Table
4
EPA
statement:
"Although
at
this
time
two­
generation
rat
reproduction
study
data
are
not
available,
…"
Aventis'
comment:
A
two­
generation
rat
reproduction
study
has
been
submitted
and
found
to
be
acceptable
by
the
Agency
(MRID#
45448101).
