Document ID: EPA-HQ-OPP-2003-0124-0009
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2003-04-10T04:00Z

RICHARD
J.
OTTEN
Registration
and
Regulatory
Services
PMB
239,
7474
Creedmoor
Road,
Raleigh,
NC
27613
PHONE:
919­
846­
7860
FAX:
919­
846­
2775
Email:
dgminc@
bellsouth.
net
March
5,
2003
Mr.
Mark
Howard
Reregistration
Branch,
SRRD
(
H7508W)

U.
S.
Environmental
Protection
Agency
Ariel
Rios
Building
1200
Pennsylvania
Ave,
N.
W.

Washington
DC
20460
RE:
Tolerance
Reregistration
Eligibility
Decision
(
TRED)
for
4­
CPA
Dear
Mark:

The
document
from
Mr.
Michael
Goodis
was
received
by
us
on
February
18,
2003.
Therefore,
we
are
responding
well
within
the
30­
day
period
requested
in
his
letter.
In
general,
we
agree
that
the
document
correctly
identifies
data,
discussion
at
the
previous
SMART
meetings,
waivers
and
minor
use
considerations.
Since
then,
there
are
several
additional
comments
for
your
consideration:

1.
I'm
told
that
all
use
of
this
compound
for
suppression
of
mung
bean
sprouting
has
been
consolidated
in
one
location
(
LaChoy)
rather
than
the
two
or
three
possible
locations
mentioned
in
the
TRED,
thus
reducing
potential
exposure
from
use
even
more.

2.
We
continue
to
recommend
that
EPA
take
the
administrative
steps
to
reduce
the
published
residue
tolerance
from
2.0
to
0.2
ppm.
Whereas
the
calculated
risk
is
acceptable
at
the
higher
level,
we
feel
it
is
in
the
best
interest
of
EPA
and
the
compound
to
have
the
published
residue
tolerance
more
accurately
reflect
the
real­
life
residue
potential.

3.
We
were
pleased
that
the
TRED
recognized
the
ongoing
discussions
between
EPA
and
registrants
of
the
major
phenoxy
herbicides
regarding
the
preference
of
using
rats
as
the
model
for
potential
toxicological
effects
on
man,
rather
than
dogs.

It
may
take
several
years
for
agreement
to
be
reached.
Thus,
it
is
understandable
that
EPA
take
the
conservative
approach
in
this
TRED
and
base
its
calculations
on
effect
levels
in
dogs.
In
the
interest
of
scientific
accuracy,
we
may
run
the
risk
calculations
using
effect
levels
in
rats
to
see
if
there
is
a
major
difference
in
conclusions.

4.
Otherwise,
there
is
no
additional
data
being
developed
by
Conagra
Grocery
Product
Company
at
this
time.

We
were
a
little
surprised
that
EPA
included
in
the
TRED
comments
on
older
(
1965
era)
non­
GLP
studies
on
reproductive
effects.
We
wonder
if
these
comments
add
anything
to
the
TRED,
other
than
to
show
for
the
record
that
EPA
considered
all
data
available
to
it.

5.
The
amount
of
compound
used
in
the
U.
S.
per
year
for
inhibition
of
mung
bean
root
development
continues
at
roughly
the
same
level
as
reported
to
you
previously.

Please
contact
me
if
you
or
your
associates
have
additional
questions.

Sincerely,

Dick
Richard
J.
Otten
Regulatory
Consultant
for
Conagra
Grocery
Products
Company
RJO/
dgm
cc:
Rennie
P.
Ruiz,
Ph.
D.,
Conagra
Grocery
Product
Company