Document ID: EPA-HQ-OPP-2002-0138-0019
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
CERTIFIED
MAIL
June
25,
2002
Danielle
LaRochelle
Registration
Product
Manager
Aventis
CropScience
USA
P.
O.
Box
12014
2
T.
W.
Alexander
Drive
Research
Triangle
Park,
NC
27709
Re:
Second
Error
Correction
of
Carbaryl
Risk
Assessments
Dear
Ms.
LaRochelle:

Within
two
weeks
from
the
date
of
this
letter,
please
identify
and
comment
on
any
errors
in
the
enclosed
risk
assessment
documents
for
carbaryl,
addressing
only
typographic,
mathematical,
or
computational­
type
errors.
The
enclosed
documents
include
the
human
health
and
the
environmental
fate
and
effects
risk
assessments.
Also
enclosed
for
your
reference
are
supporting
documents
for
the
human
health
risk
assessment.
Last
August,
Aventis
completed
its
first
error
correction
review
of
these
documents.
As
a
courtesy,
EPA
is
offering
Aventis
a
second
error
correction
review
of
these
documents
because
of
substantive
changes
described
later
in
this
letter.

On
receiving
your
error
correction
submission,
the
Agency
will
evaluate
your
comments
and
will
revise
the
risk
assessments
as
necessary.
At
this
phase,
EPA
will
not
address
comments
concerning
matters
of
policy,
interpretation,
or
applicability
of
data.
Aventis
will
have
ample
opportunity
to
submit
such
comments
during
the
60­
day
public
comment
period
that
will
begin
in
the
next
few
weeks.

As
part
of
your
two
week
review,
please
also
inform
the
Agency
in
writing
of
any
claims
of
confidential
business
information
(CBI)
contained
in
these
documents.
If
we
do
not
receive
notice
in
writing
of
any
such
claims
within
the
two
weeks,
we
will
assume
the
document
is
free
of
CBI.

Please
send,
in
writing,
the
results
of
your
error
correction
and
CBI
review
to:

Anthony
Britten
US
EPA
(7508C)
1200
Pennsylvania
Avenue,
N.
W.
Washington,
D.
C.
20460
E­
mail
Address:
britten.
anthony@
epa.
gov
Fax:
(703)
308­
8005
2
Background
EPA
is
offering
this
second
courtesy
error
review
because
of
substantive
changes
to
the
risk
assessments.
These
changes
were
prompted
by
new
data
Aventis
submitted
since
its
first
error
correction
review.
The
new
data
includes
a
two­
generation
rat
reproduction
study,
data
from
a
developmental
neurotoxicity
study,
and
three
dermal
studies.
EPA
also
rereviewed
carbaryl
under
the
latest
cancer
assessment
guidelines.

The
two
weeks
offered
for
this
error
review
coincides
with
the
time
necessary
to
publish
the
Federal
Register
notice
announcing
the
start
of
the
Phase
3
public
comment
period.
The
publication
process
is
now
underway.
Two
weeks
is
also
the
period
EPA
usually
offers
for
a
second
review
of
typographic,
mathematical
or
computational­
type
errors.

As
part
of
its
Phase
1
error
review,
Aventis
submitted
substantive
comments
to
the
Agency.
EPA
generally
does
not
consider
substantive
comments
received
during
Phase
1.
However,
in
this
case,
EPA
considered
the
comments
while
awaiting
and
then
analyzing
the
new
data
from
Aventis.
EPA
will
specifically
respond
to
these
comments
in
a
document
prepared
at
the
end
of
phase
3.
You
need
not
resubmit
your
substantive
comments.

Please
keep
your
review
in
the
next
two
weeks
focused
solely
on
typographic,
mathematical
or
computational­
type
errors.
Again,
Aventis
will
also
have
the
full
60­
days
of
Phase
3
to
submit
further
substantive
comments,
which
EPA
will
address
in
its
next
revision
of
the
risk
assessments.
The
appropriate
level
of
detail
for
your
error
response
would
be
the
amount
of
information
that
would
fit
in
the
margins
of
a
pen­
and­
ink
markup.
In
fact,
a
pen­
and­
ink
markup
would
be
the
preferred
response.
Please
complete
your
review
of
the
comprehensive
risk
assessments
before
focusing
attention
on
the
supporting
documents.
Prioritizing
your
review
in
this
way
will
help
ensure
the
most
significant
corrections
are
made
in
a
timely
way.
Sending
corrections
"piecemeal"
is
also
recommended.
Adopting
these
standards
of
review
should
allow
both
Aventis
and
EPA
enough
time
to
correct
the
enclosed
documents
before
their
release
for
Phase
3
public
comment.

If
you
have
questions
about
this
request,
please
contact
Anthony
Britten,
the
Chemical
Review
Manager
for
carbaryl,
at
(703)
308­
8179.

Sincerely,

//
signed
by
Anthony
Britten
for//

Betty
Shackleford,
Acting
Associate
Director
Special
Review
and
Reregistration
Division
Enclosures