Document ID: EPA-HQ-OPP-2002-0343-0001
Agency: epa
Document Type: Notice
Title: Prosulfuron; Notice of Filing Pesticide Petitions to Establish Tolerances for a Certain                
Pesticide Chemical in or on Food
Posted Date: 2002-12-31T05:00Z

79914
Federal
Register
/
Vol.
67,
No.
251
/
Tuesday,
December
31,
2002
/
Notices
conference
meeting.
See
below
for
time
limitations
on
public
comments.
Members
of
the
public
desiring
additional
information
about
the
meeting
locations
must
contact
Ms.
Zisa
Lubarov­
Walton,
EPA
Science
Advisory
Board
(
1400A),
Suite
6450FF,
U.
S.
EPA,
1200
Pennsylvania
Avenue,
NW.,
Washington,
DC
20460;
telephone/
voice
mail
at
(
202)
564
 
4533;
fax
at
(
202)
501
 
0582;
or
via
e­
mail
at
lubarovwalton
zisa@
epa.
gov.
A
copy
of
the
draft
agenda,
and
other
information
for
the
review
for
each
meeting,
will
be
posted
on
the
SAB
Web
site
(
www.
epa.
gov/
SAB/
whatsnew.
htm)
approximately
10
days
before
that
meeting.
(
a)
Availability
of
Review
Materials
 
Materials
that
are
the
subject
of
this
review
are
available
from
Ms.
Laura
Miner­
Nordstrom,
Office
of
the
Chief
Financial
Officer
or
from
Mr.
Kevin
Teichman,
Office
of
Research
and
Development.
Ms.
Laura
Miner­
Nordstrom
can
be
reached
on
(
202)
564
 
1601
or
by
e­
mail
at
Miner­
Nordstrom.
Laura@
epa.
gov
and
Mr.
Teichman
can
be
reached
on
(
202)
564
 
6705
or
via
e­
mail
on
teichman.
kevin@
epa.
gov.
(
b)
Meeting
Access
 
Individuals
requiring
special
accommodation
at
this
meeting,
including
wheelchair
access
to
the
conference
room,
should
contact
Mr.
Miller
at
least
five
business
days
prior
to
the
meeting
so
that
appropriate
arrangements
can
be
made.
(
c)
General
Information
 
Additional
information
concerning
the
Science
Advisory
Board,
its
structure,
function,
and
composition,
may
be
found
on
the
SAB
Web
site
(
http://
www.
epa.
gov/
sab)
and
in
the
Science
Advisory
Board
FY2001
Annual
Staff
Report
which
is
available
from
the
SAB
Publications
Staff
at
(
202)
564
 
4533
or
via
fax
at
(
202)
501
 
0256.

4.
Providing
Oral
or
Written
Comments
at
SAB
Meetings
It
is
the
policy
of
the
EPA
Science
Advisory
Board
to
accept
written
public
comments
of
any
length,
and
to
accommodate
oral
public
comments
whenever
possible.
The
EPA
Science
Advisory
Board
expects
that
public
statements
presented
at
its
meetings
will
not
be
repetitive
of
previously
submitted
oral
or
written
statements.
Oral
Comments:
In
general,
each
individual
or
group
requesting
an
oral
presentation
at
a
face­
to­
face
meeting
will
be
limited
to
a
total
time
of
ten
minutes
(
unless
otherwise
indicated).
For
teleconference
meetings,
opportunities
for
oral
comment
will
usually
be
limited
to
no
more
than
three
minutes
per
speaker
and
no
more
than
fifteen
minutes
total.
Deadlines
for
getting
on
the
public
speaker
list
for
a
meeting
are
given
above.
Speakers
should
bring
at
least
35
copies
of
their
comments
and
presentation
slides
for
distribution
to
the
reviewers
and
public
at
the
meeting.
Written
Comments:
Although
the
SAB
accepts
written
comments
until
the
date
of
the
meeting
(
unless
otherwise
stated),
written
comments
should
be
received
in
the
SAB
Staff
Office
at
least
one
week
prior
to
the
meeting
date
so
that
the
comments
may
be
made
available
to
the
review
panel
for
their
consideration.
Comments
should
be
supplied
to
the
appropriate
DFO
at
the
address/
contact
information
noted
above
in
the
following
formats:
one
hard
copy
with
original
signature,
and
one
electronic
copy
via
e­
mail
(
acceptable
file
format:
Adobe
Acrobat,
WordPerfect,
Word,
or
Rich
Text
files
(
in
IBM­
PC/
Windows
95/
98
format).
Those
providing
written
comments
and
who
attend
the
meeting
are
also
asked
to
bring
35
copies
of
their
comments
for
public
distribution.

Dated:
December
24,
2002.
Robert
Flaak,
Acting
Director,
EPA
Science
Advisory
Board
Staff
Office.
[
FR
Doc.
02
 
32987
Filed
12
 
30
 
02;
8:
45
am]

BILLING
CODE
6560
 
50
 
P
ENVIRONMENTAL
PROTECTION
AGENCY
[
OPP
 
2002
 
0343;
FRL
 
7284
 
7]

Prosulfuron;
Notice
of
Filing
Pesticide
Petitions
to
Establish
Tolerances
for
a
Certain
Pesticide
Chemical
in
or
on
Food
AGENCY:
Environmental
Protection
Agency
(
EPA).
ACTION:
Notice.

SUMMARY:
This
notice
announces
the
initial
filing
of
pesticide
petitions
proposing
the
establishment
of
regulations
for
residues
of
prosulfuron
in
or
on
various
food
commodities.
DATES:
Comments,
identified
by
docket
ID
number
OPP
 
2002
 
0343,
must
be
received
on
or
before
January
30,
2003.
ADDRESSES:
Comments
may
be
submitted
electronically,
by
mail,
or
through
hand
delivery/
courier.
Follow
the
detailed
instructions
as
provided
in
Unit
I.
of
the
SUPPLEMENTARY
INFORMATION.

FOR
FURTHER
INFORMATION
CONTACT:
Jim
Tompkins,
Registration
Division
(
7505C),
Office
of
Pesticide
Programs,
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460
 
0001;
telephone
number:
(
703)
305
 
5697;
e­
mail
address:
tompkins.
jim@
epa.
gov.

SUPPLEMENTARY
INFORMATION:

I.
General
Information
A.
Does
this
Action
Apply
to
Me?

You
may
be
affected
by
this
action
if
you
are
an
agricultural
producer,
food
manufacturer,
or
pesticide
manufacturer.
Potentially
affected
categories
and
entities
may
include,
but
are
not
limited
to:
 
Crop
production
(
NAICS
code
111)
 
Animal
production
(
NAICS
code
112)
 
Food
manufacturing
(
NAICS
code
311)
 
Pesticide
manufacturing
(
NAICS
code
32532)
This
listing
is
not
intended
to
be
exhaustive,
but
rather
provides
a
guide
for
readers
regarding
entities
likely
to
be
affected
by
this
action.
Other
types
of
entities
not
listed
in
this
unit
could
also
be
affected.
The
North
American
Industrial
Classification
System
(
NAICS)
codes
have
been
provided
to
assist
you
and
others
in
determining
whether
this
action
might
apply
to
certain
entities.
If
you
have
questions
regarding
the
applicability
of
this
action
to
a
particular
entity,
consult
the
person
listed
under
FOR
FURTHER
INFORMATION
CONTACT.

B.
How
Can
I
Get
Copies
of
this
Document
and
Other
Related
Information?

1.
Docket.
EPA
has
established
an
official
public
docket
for
this
action
under
docket
identification
(
ID)
number
OPP
 
2002
 
0343.
The
official
public
docket
consists
of
the
documents
specifically
referenced
in
this
action,
any
public
comments
received,
and
other
information
related
to
this
action.
Although
a
part
of
the
official
docket,
the
public
docket
does
not
include
Confidential
Business
Information
(
CBI)
or
other
information
whose
disclosure
is
restricted
by
statute.
The
official
public
docket
is
the
collection
of
materials
that
is
available
for
public
viewing
at
the
Public
Information
and
Records
Integrity
Branch
(
PIRIB),
Rm.
119,
Crystal
Mall
#
2,
1921
Jefferson
Davis
Hwy.,
Arlington,
VA.
This
docket
facility
is
open
from
8:
30
a.
m.
to
4
p.
m.,
Monday
through
Friday,
excluding
legal
holidays.
The
docket
telephone
number
is
(
703)
305
 
5805.
2.
Electronic
access.
You
may
access
this
Federal
Register
document
electronically
through
the
EPA
Internet
under
the
``
Federal
Register''
listings
at
http://
www.
epa.
gov/
fedrgstr/.
An
electronic
version
of
the
public
docket
is
available
through
EPA's
VerDate
Dec<
13>
2002
16:
26
Dec
30,
2002
Jkt
200001
PO
00000
Frm
00014
Fmt
4703
Sfmt
4703
E:\
FR\
FM\
31DEN1.
SGM
31DEN1
79915
Federal
Register
/
Vol.
67,
No.
251
/
Tuesday,
December
31,
2002
/
Notices
electronic
public
docket
and
comment
system,
EPA
Dockets.
You
may
use
EPA
Dockets
at
http://
www.
epa.
gov/
edocket/
to
submit
or
view
public
comments,
access
the
index
listing
of
the
contents
of
the
official
public
docket,
and
to
access
those
documents
in
the
public
docket
that
are
available
electronically.
Although
not
all
docket
materials
may
be
available
electronically,
you
may
still
access
any
of
the
publicly
available
docket
materials
through
the
docket
facility
identified
in
Unit
I.
B.
1.
Once
in
the
system,
select
``
search,''
then
key
in
the
appropriate
docket
ID
number.
Certain
types
of
information
will
not
be
placed
in
the
EPA
Dockets.
Information
claimed
as
CBI
and
other
information
whose
disclosure
is
restricted
by
statute,
which
is
not
included
in
the
official
public
docket,
will
not
be
available
for
public
viewing
in
EPA's
electronic
public
docket.
EPA's
policy
is
that
copyrighted
material
will
not
be
placed
in
EPA's
electronic
public
docket
but
will
be
available
only
in
printed,
paper
form
in
the
official
public
docket.
To
the
extent
feasible,
publicly
available
docket
materials
will
be
made
available
in
EPA's
electronic
public
docket.
When
a
document
is
selected
from
the
index
list
in
EPA
Dockets,
the
system
will
identify
whether
the
document
is
available
for
viewing
in
EPA's
electronic
public
docket.
Although
not
all
docket
materials
may
be
available
electronically,
you
may
still
access
any
of
the
publicly
available
docket
materials
through
the
docket
facility
identified
in
Unit
I.
B.
EPA
intends
to
work
towards
providing
electronic
access
to
all
of
the
publicly
available
docket
materials
through
EPA's
electronic
public
docket.
For
public
commenters,
it
is
important
to
note
that
EPA's
policy
is
that
public
comments,
whether
submitted
electronically
or
in
paper,
will
be
made
available
for
public
viewing
in
EPA's
electronic
public
docket
as
EPA
receives
them
and
without
change,
unless
the
comment
contains
copyrighted
material,
CBI,
or
other
information
whose
disclosure
is
restricted
by
statute.
When
EPA
identifies
a
comment
containing
copyrighted
material,
EPA
will
provide
a
reference
to
that
material
in
the
version
of
the
comment
that
is
placed
in
EPA's
electronic
public
docket.
The
entire
printed
comment,
including
the
copyrighted
material,
will
be
available
in
the
public
docket.
Public
comments
submitted
on
computer
disks
that
are
mailed
or
delivered
to
the
docket
will
be
transferred
to
EPA's
electronic
public
docket.
Public
comments
that
are
mailed
or
delivered
to
the
docket
will
be
scanned
and
placed
in
EPA's
electronic
public
docket.
Where
practical,
physical
objects
will
be
photographed,
and
the
photograph
will
be
placed
in
EPA's
electronic
public
docket
along
with
a
brief
description
written
by
the
docket
staff.

C.
How
and
To
Whom
Do
I
Submit
Comments?

You
may
submit
comments
electronically,
by
mail,
or
through
hand
delivery/
courier.
To
ensure
proper
receipt
by
EPA,
identify
the
appropriate
docket
ID
number
in
the
subject
line
on
the
first
page
of
your
comment.
Please
ensure
that
your
comments
are
submitted
within
the
specified
comment
period.
Comments
received
after
the
close
of
the
comment
period
will
be
marked
``
late.''
EPA
is
not
required
to
consider
these
late
comments.
If
you
wish
to
submit
CBI
or
information
that
is
otherwise
protected
by
statute,
please
follow
the
instructions
in
Unit
I.
D.
Do
not
use
EPA
Dockets
or
e­
mail
to
submit
CBI
or
information
protected
by
statute.
1.
Electronically.
If
you
submit
an
electronic
comment
as
prescribed
in
this
unit,
EPA
recommends
that
you
include
your
name,
mailing
address,
and
an
email
address
or
other
contact
information
in
the
body
of
your
comment.
Also
include
this
contact
information
on
the
outside
of
any
disk
or
CD
ROM
you
submit,
and
in
any
cover
letter
accompanying
the
disk
or
CD
ROM.
This
ensures
that
you
can
be
identified
as
the
submitter
of
the
comment
and
allows
EPA
to
contact
you
in
case
EPA
cannot
read
your
comment
due
to
technical
difficulties
or
needs
further
information
on
the
substance
of
your
comment.
EPA's
policy
is
that
EPA
will
not
edit
your
comment,
and
any
identifying
or
contact
information
provided
in
the
body
of
a
comment
will
be
included
as
part
of
the
comment
that
is
placed
in
the
official
public
docket,
and
made
available
in
EPA's
electronic
public
docket.
If
EPA
cannot
read
your
comment
due
to
technical
difficulties
and
cannot
contact
you
for
clarification,
EPA
may
not
be
able
to
consider
your
comment.
i.
EPA
Dockets.
Your
use
of
EPA's
electronic
public
docket
to
submit
comments
to
EPA
electronically
is
EPA's
preferred
method
for
receiving
comments.
Go
directly
to
EPA
Dockets
at
http://
www.
epa.
gov/
edocket,
and
follow
the
online
instructions
for
submitting
comments.
Once
in
the
system,
select
``
search,''
and
then
key
in
docket
ID
number
OPP
 
2002
 
0343.
The
system
is
an
``
anonymous
access''
system,
which
means
EPA
will
not
know
your
identity,
e­
mail
address,
or
other
contact
information
unless
you
provide
it
in
the
body
of
your
comment.
ii.
E­
mail.
Comments
may
be
sent
by
e­
mail
to
opp­
docket@
epa.
gov,
Attention:
Docket
ID
Number
OPP
 
2002
 
0343.
In
contrast
to
EPA's
electronic
public
docket,
EPA's
e­
mail
system
is
not
an
``
anonymous
access''
system.
If
you
send
an
e­
mail
comment
directly
to
the
docket
without
going
through
EPA's
electronic
public
docket,
EPA's
e­
mail
system
automatically
captures
your
e­
mail
address.
E­
mail
addresses
that
are
automatically
captured
by
EPA's
e­
mail
system
are
included
as
part
of
the
comment
that
is
placed
in
the
official
public
docket,
and
made
available
in
EPA's
electronic
public
docket.
iii.
Disk
or
CD
ROM.
You
may
submit
comments
on
a
disk
or
CD
ROM
that
you
mail
to
the
mailing
address
identified
in
Unit
I.
C.
2.
These
electronic
submissions
will
be
accepted
in
WordPerfect
or
ASCII
file
format.
Avoid
the
use
of
special
characters
and
any
form
of
encryption.
2.
By
mail.
Send
your
comments
to:
Public
Information
and
Records
Integrity
Branch
(
PIRIB)
(
7502C),
Office
of
Pesticide
Programs
(
OPP),
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460
 
0001,
Attention:
Docket
ID
Number
OPP
 
2002
 
0343.
3.
By
hand
delivery
or
courier.
Deliver
your
comments
to:
Public
Information
and
Records
Integrity
Branch
(
PIRIB),
Office
of
Pesticide
Programs
(
OPP),
Environmental
Protection
Agency,
Rm.
119,
Crystal
Mall
#
2,
1921
Jefferson
Davis
Hwy.,
Arlington,
VA,
Attention:
Docket
ID
Number
OPP
 
2002
 
0343.
Such
deliveries
are
only
accepted
during
the
docket's
normal
hours
of
operation
as
identified
in
Unit
I.
B.
1.

D.
How
Should
I
Submit
CBI
To
the
Agency?
Do
not
submit
information
that
you
consider
to
be
CBI
electronically
through
EPA's
electronic
public
docket
or
by
e­
mail.
You
may
claim
information
that
you
submit
to
EPA
as
CBI
by
marking
any
part
or
all
of
that
information
as
CBI
(
if
you
submit
CBI
on
disk
or
CD
ROM,
mark
the
outside
of
the
disk
or
CD
ROM
as
CBI
and
then
identify
electronically
within
the
disk
or
CD
ROM
the
specific
information
that
is
CBI).
Information
so
marked
will
not
be
disclosed
except
in
accordance
with
procedures
set
forth
in
40
CFR
part
2.
In
addition
to
one
complete
version
of
the
comment
that
includes
any
information
claimed
as
CBI,
a
copy
of
the
comment
that
does
not
contain
the
information
claimed
as
CBI
must
be
submitted
for
inclusion
in
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/
Vol.
67,
No.
251
/
Tuesday,
December
31,
2002
/
Notices
docket
and
EPA's
electronic
public
docket.
If
you
submit
the
copy
that
does
not
contain
CBI
on
disk
or
CD
ROM,
mark
the
outside
of
the
disk
or
CD
ROM
clearly
that
it
does
not
contain
CBI.
Information
not
marked
as
CBI
will
be
included
in
the
public
docket
and
EPA's
electronic
public
docket
without
prior
notice.
If
you
have
any
questions
about
CBI
or
the
procedures
for
claiming
CBI,
please
consult
the
person
listed
under
FOR
FURTHER
INFORMATION
CONTACT.

E.
What
Should
I
Consider
as
I
Prepare
My
Comments
for
EPA?

You
may
find
the
following
suggestions
helpful
for
preparing
your
comments:
1.
Explain
your
views
as
clearly
as
possible.
2.
Describe
any
assumptions
that
you
used.
3.
Provide
copies
of
any
technical
information
and/
or
data
you
used
that
support
your
views.
4.
If
you
estimate
potential
burden
or
costs,
explain
how
you
arrived
at
the
estimate
that
you
provide.
5.
Provide
specific
examples
to
illustrate
your
concerns.
6.
Make
sure
to
submit
your
comments
by
the
deadline
in
this
notice.
7.
To
ensure
proper
receipt
by
EPA,
be
sure
to
identify
the
docket
ID
number
assigned
to
this
action
in
the
subject
line
on
the
first
page
of
your
response.
You
may
also
provide
the
name,
date,
and
Federal
Register
citation.

II.
What
Action
is
the
Agency
Taking?

EPA
has
received
a
pesticide
petition
as
follows
proposing
the
establishment
and/
or
amendment
of
regulations
for
residues
of
a
certain
pesticide
chemical
in
or
on
various
food
commodities
under
section
408
of
the
Federal
Food,
Drug,
and
Cosmetic
Act
(
FFDCA),
21
U.
S.
C.
346a.
EPA
has
determined
that
this
petition
contains
data
or
information
regarding
the
elements
set
forth
in
FFDCA
section
408(
d)(
2);
however,
EPA
has
not
fully
evaluated
the
sufficiency
of
the
submitted
data
at
this
time
or
whether
the
data
support
granting
of
the
petition.
Additional
data
may
be
needed
before
EPA
rules
on
the
petition.

List
of
Subjects
Environmental
protection,
Agricultural
commodities,
Feed
additives,
Food
additives,
Pesticides
and
pests,
Reporting
and
recordkeeping
requirements.
Dated:
December
20,
2002.
Debra
Edwards,
Acting
Director,
Registration
Division,
Office
of
Pesticide
Programs.

Summary
of
Petitions
The
petitioner's
summary
of
the
pesticide
petitions
is
printed
below
as
required
by
FFDCA
section
408(
d)(
3).
The
summary
of
the
petitions
was
prepared
by
the
petitioner
and
represents
the
view
of
the
petitioner.
The
petitions
summary
announces
the
availability
of
a
description
of
the
analytical
methods
available
to
EPA
for
the
detection
and
measurement
of
the
pesticide
chemical
residues
or
an
explanation
of
why
no
such
method
is
needed.
EPA
has
received
pesticide
petitions
(
PP
5F4469)
and
(
PP
4F4336),
from
Syngenta
Crop
Protection,
Inc.,
P.
O.
Box
18300,
Greensboro,
NC
27419
 
8300
proposing,
pursuant
to
section
408(
d)
of
the
Federal
Food,
Drug,
and
Cosmetic
Act
(
FFDCA),
21
U.
S.
C.
346a(
d),
to
amend
40
CFR
part
180
by
establishing
a
tolerance
for
residues
of
prosulfuron,
1­(
4­
methoxy­
6­
methyl­
triazin­
2­
yl)­
3­
[
2­(
3,3,3­
trifluoropropyl)­
phenylsulfonyl]­
urea
in
or
on
the
raw
agricultural
commodities,
cereal
grains
group
(
except
rice
and
wild
rice)
grain
at
0.01
parts
per
million
(
ppm),
cereal
grains
group
(
except
rice
and
wild
rice)
forage
at
0.10
ppm,
cereal
grains
group
(
except
rice
and
wild
rice)
fodder
at
0.01
ppm,
cereal
grains
group
(
except
rice
and
wild
rice)
straw
at
0.02
ppm,
cereal
grains
group
(
except
rice
and
wild
rice)
hay
at
0.20
ppm,
milk
at
0.01
ppm,
meat,
fat,
kidney,
liver,
and
meat
byproducts
of
cattle,
goats,
hogs,
horses,
and
sheep
at
0.05
ppm.
EPA
has
determined
that
the
petition
contains
data
or
information
regarding
the
elements
set
forth
in
section
408(
d)(
2)
of
the
FFDCA;
however,
EPA
has
not
fully
evaluated
the
sufficiency
of
the
submitted
data
at
this
time
or
whether
the
data
support
granting
of
the
petition.
Additional
data
may
be
needed
before
EPA
rules
on
the
petition.
This
is
a
revised
notice
of
filing
to
amend
a
previous
notice
of
filing
published
in
the
Federal
Register
of
August
25,
1999
(
FR
64
46382)
(
FRL
 
6093
 
7),
to
propose
permanent
tolerances,
instead
of
the
current
timelimited
tolerances
for
prosulfuron.

A.
Residue
Chemistry
1.
Plant
metabolism.
The
nature
of
the
residue
of
prosulfuron
in
corn
is
adequately
understood.
Significant
pathways
involve
oxidation
of
the
phenyl
ring
to
give
5
 
hydroxy
prosulfuron,
which
is
followed
by
sugar
conjugation.
Hydrolytic
cleavage
of
the
sulfonylurea
bridge
occurs
for
both
prosulfuron
and
5
 
hydroxy
prosulfuron,
yielding
the
corresponding
sulfonamide
and
triazine
amine
moieties.
The
sulfonamide
metabolites
are
subsequently
conjugated
with
sugars.
Demethylation
of
the
triazine
amine
results
in
the
formation
of
the
corresponding
hydroxy
triazine,
which
is
further
hydrolyzed
at
the
amino
group
to
form
the
dihydroxy
triazine.
2.
Analytical
method.
Adequate
analytical
methods
exist
for
the
detection
and
measurement
of
residue
levels
of
prosulfuron
in
or
on
raw
and
processed
commodities
of
cereal
grains,
and
for
meat,
milk
and
eggs.
The
limit
of
quantitation
(
LOQ)
is
0.01
ppm
for
crop
commodities,
processed
fractions
and
milk,
and
0.05
ppm
for
meat
and
eggs.
The
method
is
based
on
commodity­
specific
cleanup
procedures
followed
by
determination
by
high
performance
liquid
chromatography
with
ultraviolet
(
UV)
detection.
3.
Magnitude
of
residues.
Complete,
full
geography
residue
programs,
including
processing,
have
been
conducted
on
corn,
wheat
and
grain
sorghum.
A
three­
level
dairy
animal
feeding
study
to
determine
the
transfer
of
residues
of
prosulfuron
from
animal
feed
commodities
to
meat
and
milk
has
also
been
conducted.

B.
Toxicological
Profile
1.
Acute
toxicity.
EPA
has
set
an
acute
reference
dose
of
0.1
milligram/
kilogram/
day
(
mg/
kg/
day)
based
upon
a
no
observed
adverse
effect
level
(
NOAEL)
of
10
mg/
kg/
day
from
the
rat
acute
neurotoxicity
study
(
lowest
observed
adverse
effect
level
(
LOAEL)
of
250
mg/
kg/
day
due
to
reduced
motor
activity
and
body
temperature
in
males
and
impaired
righting
reflex
in
females)
and
a
100
 
fold
uncertainty
factor
(
UF).
2.
Genotoxicty.
Prosulfuron
was
negative
for
mutagenic/
genotoxic
effects
when
tested
in
a
bacterial
reverse
gene
mutation
assay
with
and
without
metabolic
activation
using
different
S.
typhimurium
and
E.
coli
stains;
in
a
mammalian
gene
mutation
study
using
V79
cells;
in
an
in
vitro
mammalian
cytogenetic
test
using
Chinese
hamster
ovary
(
CHO)
cells
with
and
without
metabolic
activation;
in
a
micronucleus
test
in
mice;
and
in
a
DNA­
repair
using
freshly
isolated
rat
liver
hepatocytes.
3.
Reproductive
and
developmental
toxicity.
The
data
base
on
prosulfuron
relative
to
prenatal
and
postnatal
effects
for
children
is
considered
to
be
essentially
complete
with
no
data
gaps.
The
developmental
and
reproductive
toxicity
data
do
not
indicate
increase
susceptibility
of
rats
or
rabbits
to
in
utero
and/
or
postnatal
exposure
to
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Vol.
67,
No.
251
/
Tuesday,
December
31,
2002
/
Notices
prosulfuron.
In
a
rat
teratology
study,
evidence
of
maternal
toxicity
(
decreased
body
weight
gain
and
reduced
food
consumption)
and
developmental
toxicity
(
increased
incidence
of
skeletal
variations
that
was
not
significantly
different
from
the
historical
control)
was
found
at
the
maximum
tolerated
dose
of
400
mg/
kg.
There
was
no
evidence
of
teratogenicity
at
any
dose,
and
the
maternal
and
developmental
NOAELs
were
established
at
200
mg/
kg.
In
a
rabbit
teratology
study,
maternal
toxicity
(
decreased
body
weight
gain
and
reduced
food
consumption)
was
observed
in
the
100
mg/
kg
dose
group.
There
was
no
evidence
of
teratogenicity
at
any
dose.
Since
a
range­
finding
rabbit
teratology
study
had
seen
additional
clinical
findings
and
fetotoxicity
at
maternally
toxic
doses
( 
150
mg/
kg)
but
not
in
the
definitive
study
at
up
to
100
mg/
kg,
a
second
rabbit
teratology
study
was
conducted
at
doses
of
0,
20,
100,
and
200
mg/
kg/
day.
Maternal
toxicity
was
observed
at
200
mg/
kg.
The
developmental
NOAEL
was
100
mg/
kg
and
the
maternal
NOAEL
was
20
mg/
kg
in
this
study.
There
was
no
evidence
of
teratogenicity
at
any
dose.
A
rat
multigenerational
reproduction
study
indicated
reproductive
and
systemic
NOAELs
of
13.3
mg/
kg/
day
based
on
decreased
mean
body
weights
and
body
weight
gain
observed
at
136
mg/
kg/
day
for
both
pups
and
parental
animals.
No
treatment­
related
effects
on
reproductive
performance
(
i.
e.,
to
produce,
deliver
or
raise
litters),
litter
sizes,
viability
of
pups,
and
necropsy
findings
in
parental
animals
and
offspring
were
noted
up
to
the
highest
dose
level.
4.
Subchronic
toxicity.
The
liver
was
identified
as
a
target
organ
at
high
doses
in
the
rat,
mouse,
and
dog
as
indicated
by
slightly
increased
liver
enzymes
and
liver
weights.
No
histomorphologic
correlates
of
liver
damage
was
noted
in
the
90
 
day
studies
except
in
the
mouse
study
where
centrilobular
hypertrophy
was
found
in
males
at
feeding
levels
 
1,750
ppm
and
in
females
at
levels
 
3,500
ppm.
In
general,
NOAELs
for
target
organ
effects
were
established
at
doses
that
were
much
higher
than
overall
study
NOAELs,
which
were
based
on
other
indicators
of
toxicity
such
body
weight
gain.
5.
Chronic
toxicity.
In
the
1
 
year
dog
chronic
dosing
study,
the
NOAEL
was
1.84
mg/
kg/
day
based
on
hematologic
and
clinical
chemistry
effects
and
incidence
of
lipofuscin
accumulation
in
the
liver
at
18.6
mg/
kg/
day.
In
the
18
 
month
mouse
carcinogenicity
study,
there
was
no
evidence
of
carcinogenic
effects
up
to
the
highest
dose
tested
(
HDT)
of
1,062
mg/
kg/
day.
The
NOAEL
was
1.71
mg/
kg/
day
in
males,
and
100
mg/
kg/
day
in
females
based
on
increased
incidence/
severity
of
centrilobular
hepatocellular
hypertrophy.
A
2
 
year
chronic
feeding/
carcinogenicity
study
in
rats
indicated
systemic
NOAEL
of
7.9
mg/
kg/
day
was
based
on
decreased
body
weight
and
body
weight
gain,
hematopoietic
effects
(
males),
and
possibly
increased
serum
GGT
and
decreased
liver,
kidney,
and
adrenal
weights
(
females)
at
79.9
mg/
kg/
day.
There
was
uncertain
evidence
of
carcinogenicity
with
slight
increases
in
the
incidence
of
mammary
gland
adenocarcinomas
in
females
at
95.7
and
205.8
mg/
kg/
day,
slight
increase
in
incidence
of
benign
testicular
interstitial
cell
tumors
at
79.9
and
160.9
mg/
kg/
day
(
significant
trend
only).
Considering
the
weight
of
the
evidence,
the
EPA
Reference
Dose
Committee
previously
concluded
that
the
chemical
should
be
classified
as
a
Group
D
carcinogen
(
inadequate
evidence),
not
classifiable
as
to
human
carcinogenicity.
The
HIARC
(
meeting
December
2,
1999)
accepted
the
previous
conclusions
and
updated
the
cancer
classification
to
the
new
classification:
``
data
are
inadeqate,''
with
no
new
studies
required.
EPA
has
set
a
chronic
reference
dose
of
0.02
mg/
kg
based
on
a
NOAEL
of
1.84
mg/
kg
in
a
dog
feeding
study
and
a
100
 
fold
UF.
6.
Animal
metabolism.
The
metabolic
pathways
in
the
rat,
goat,
and
hen
are
similar
and
are
adequately
understood.
Prosulfuron
is
rapidly
absorbed
from
the
gastrointestinal
(
GI)
tract
of
rats
and
is
rapidly
excreted.
Approximately
90%
of
the
administered
dose
is
excreted
during
the
first
48
hours,
predominately
via
urine.
Tissue
residues
are
low.
Prosulfuron
is
metabolized
primarily
via
hydroxylation
at
side
chain
and
phenyl
ring
positions
and
O­
demethylation
of
the
triazyl
methoxy
group.
Minor
pathways
include
unsaturation
of
the
trifluoropropyl
side
chain,
hydrolysis
of
the
phenylsulfonylurea
bridge
and
oxidative/
hydrolytic
cleavage
of
the
triazine
ring
system.
In
the
goat,
the
orally
administered
prosulfuron
is
quickly
eliminated
primarily
via
the
urine
as
prosulfuron.
The
metabolism
of
prosulfuron
in
the
goat
follows
a
similar
pathway
as
observed
in
the
rat
although
not
as
extensive.
The
majority
of
the
residues
were
accounted
for
as
prosulfuron,
the
triazine
amine,
which
results
from
bridge
hydrolysis
(
CGA
 
150829)
and
the
triazinyl
hydroxymethyl
metabolite
(
CGA
 
273437).
In
the
hen,
metabolism
is
similar
to
that
observed
in
the
rat
and
goat.
The
major
residues
found
in
edible
tissues
and
eggs
were
prosulfuron,
the
triazine
amine
(
CGA
 
150829),
and
the
sulfonamide
(
CGA
 
159902)
which
results
from
hydrolysis
of
the
sulfonylurea
bridge.
7.
Metabolite
toxicology.
Metabolic
pathways
of
prosulfuron
in
plants
and
animals
are
comparable
and
no
detectable
residues
are
found
in
or
on
crops.
All
relevant
plant
metabolites
are
observed
in
the
animals
and
are
thus
toxicologically
covered.
The
remaining
plant
metabolites
are
toxicologically
insignificant.
Therefore,
parent
prosulfuron
is
the
appropriate
compound
for
the
tolerance
expression
and
analytical
monitoring.
8.
Endocrine
disruption.
Prosulfuron
does
not
belong
to
a
class
of
chemicals
known
for
having
significant
adverse
effects
on
the
endocrine
system.
Developmental
toxicity
studies
in
rats
and
rabbits
and
reproduction
study
in
rats
gave
no
indication
that
prosulfuron
might
have
any
effects
on
endocrine
function
related
to
development
and
reproduction.
The
subchronic
and
chronic
studies
also
showed
no
evidence
of
a
long­
term
effect
related
to
the
endocrine
system.

C.
Aggregate
Exposure
1.
Dietary
exposure.
Acute
and
chronic
dietary
exposure
assessments
were
conducted
for
prosulfuron
using
tolerance
values
published
in
40
CFR
180.481.
In
both
assessments
it
was
assumed
that
100%
of
all
corn
and
cereal
grains
were
treated
with
prosulfuron
(
100%
market
share).
The
exposure
analyses
was
conducted
using
food
consumption
data
from
USDA's
1994
 
1996
Continuing
Survey
of
Intake
by
Individuals
(
CSFII)
and
Novigen
Sciences,
Inc.
Dietary
Exposure
Evaluation
Model
(
DEEM).
i.
Food.
Chronic
exposure
was
compared
to
a
RfD
of
0.02
mg/
kg
based
on
a
NOAEL
of
1.84
mg/
kg
in
a
dog
feeding
study
and
a
100
 
fold
UF.
This
exposure
analysis
showed
that
the
U.
S.
population
had
an
exposure
of
less
than
1%
of
the
chronic
RfD.
The
most
sensitive
subpopulation
was
children
(
1
 
6
years
old)
with
a
chronic
exposure
of
2.4%.
Acute
exposure
was
compared
to
an
acute
RfD
of
0.1
mg/
kg,
which
was
based
on
a
NOAEL
of
10
mg/
kg
from
an
acute
neurotoxicity
study
in
the
rat
and
a
100
 
fold
UF.
The
most
sensitive
subpopulation
was
all
infants
with
an
exposure
of
2.2%
of
the
acute
RfD.
The
U.
S.
population
showed
an
exposure
of
1.5%
of
the
RfD.
These
results
show
that
there
is
more
than
a
reasonable
certainty
of
no
harm,
through
exposure
to
prosulfuron
residues
in
the
diet.
ii.
Drinking
water.
For
estimated
surface
water
concentrations
using
generic
expected
environmental
concentration
(
GENEEC),
the
peak
day
 
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Federal
Register
/
Vol.
67,
No.
251
/
Tuesday,
December
31,
2002
/
Notices
0
estimate,
1.86
parts
per
billion
(
ppb),
was
used
in
the
acute
exposure
analysis
and
the
corrected
56
 
day
drinking
water
concentration
of
0.4667
ppb
was
used
in
the
chronic
exposure
analysis.
The
SCIGROW
estimated
ground
water
concentration
for
the
prosulfuron
uses
of
0.406585
ppb
contributed
little
to
the
overall
exposure.
The
acute
drinking
water
levels
of
concern
(
DWLOC)
for
prosulfuron
were
based
on
the
acute
RfD,
a
margin
of
exposure
(
MOE),
the
99.9th
percentile
of
the
acute
dietary
exposure
for
U.
S.
population
subgroups
and
the
body
weight
­
daily
water
consumption
of
each
respective
subgroup.
The
calculated
acute
DWLOC
values
for
the
population
subgroups
ranged
from
978
 
3447
ppb.
The
estimated
ground
water
concentration
(
0.406585
ppb)
and
the
peak
day
 
0
surface
water
concentration
(
1.86
ppb)
of
prosulfuron
did
not
exceed
the
acute
DWLOC
values.
The
chronic
(
noncancer
DWLOC
for
prosulfuron
were
based
on
the
chronic
RfD,
any
estimated
residential
exposure,
the
chronic
dietary
exposure
for
select
U.
S.
population
subgroups
and
the
body
weight
­
daily
water
consumption
of
each
respective
subgroup.
The
calculated
chronic
DWLOC
values
for
the
population
subgroups
ranged
from
197
 
694.
The
estimated
ground
water
concentration
(
0.406585
ppb)
and
the
corrected
average
56
 
day
surface
water
concentration
(
0.4667
ppb)
of
prosulfuron
did
not
exceed
the
chronic
DWLOC
values.
Therefore,
there
is
reasonable
certainty
that
the
residues
of
prosulfuron
in
the
drinking
water
would
not
result
in
unacceptable
levels
of
acute
or
chronic
aggregate
human
health
risk,
and
that
such
exposure
would
not
exceed
the
exposure
allowable
by
the
risk
cup.
Nondietary
exposure.
Nondietary
exposure
to
prosulfuron
is
considered
negligible
as
the
chemical
is
registered
for
agricultural
use
only.
For
workers
handling
this
chemical,
acceptable
MOE
(
in
the
range
of
thousands)
have
been
obtained
for
both
acute
and
chronic
scenarios.

D.
Cumulative
Effects
Consideration
of
a
common
mechanism
of
toxicity
is
not
appropriate
at
this
time
since
there
is
no
information
to
indicate
that
toxic
effects
produced
by
prosulfuron
would
be
cumulative
with
those
of
any
other
types
of
chemicals.

E.
Safety
Determination
1.
U.
S.
population.
The
calculation
shows
that
less
than
1%
of
the
RfD
will
be
utilized
for
the
U.
S.
population
based
on
chronic
toxicity
endpoints.
EPA
generally
has
no
concern
for
exposures
below
100%
of
the
RfD
because
the
RfD
represents
the
level
at
or
below
which
daily
aggregate
dietary
exposure
over
a
lifetime
will
not
pose
appreciable
risks
to
human
health.
It
is
concluded
that
there
is
a
reasonable
certainty
that
no
harm
will
result
from
aggregate
exposure
to
prosulfuron
residue.
2.
Infants
and
children.
The
calculated
percent
of
the
RfD
that
will
be
utilized
by
aggregate
exposure
to
residues
of
prosulfuron
is
only
2.4%
for
children
(
1
to
6
years
old),
the
most
impacted
subpopulation.
There
were
no
adverse
reproductive
or
developmental
effects
indicated
in
the
prosulfuron
toxicity
data
base,
which
is
considered
to
be
essentially
complete
with
no
data
gaps.
It
is
concluded
that
there
is
a
reasonable
certainty
that
no
harm
will
result
to
infants
and
children
from
aggregate
exposure
to
prosulfuron
residues.

F.
International
Tolerances
No
codex
MRLs
have
been
established
for
residues
of
prosulfuron.
[
FR
Doc.
02
 
32988
Filed
12
 
30
 
02;
8:
45
am]

BILLING
CODE
6560
 
50
 
S
ENVIRONMENTAL
PROTECTION
AGENCY
[
OPP
 
2002
 
0349;
FRL
 
7285
 
6]

Flumioxazin;
Notice
of
Filing
a
Pesticide
Petition
to
Establish
a
Tolerance
for
a
Certain
Pesticide
Chemical
in
or
on
Food
AGENCY:
Environmental
Protection
Agency
(
EPA).
ACTION:
Notice.

SUMMARY:
This
notice
announces
the
initial
filing
of
pesticide
petitions
proposing
the
establishment
of
regulations
for
residues
of
a
certain
pesticide
chemical
in
or
on
various
food
commodities.
DATES:
Comments,
identified
by
docket
ID
number
OPP
 
2002
 
0349,
must
be
received
on
or
before
January
30,
2003.
ADDRESSES:
Comments
may
be
submitted
electronically,
by
mail,
or
through
hand
delivery/
courier.
Follow
the
detailed
instructions
as
provided
in
Unit
I.
of
the
SUPPLEMENTARY
INFORMATION.

FOR
FURTHER
INFORMATION
CONTACT:
Joanne
I.
Miller,
Registration
Division
(
7505C),
Office
of
Pesticide
Programs,
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460
 
0001;
telephone
number:
(
703)
305
 
6224;
e­
mail
address:
Miller.
Joanne@
epamail.
epa.
gov.
SUPPLEMENTARY
INFORMATION:

I.
General
Information
A.
Does
this
Action
Apply
to
Me?

You
may
be
affected
by
this
action
if
you
are
an
agricultural
producer,
food
manufacturer,
or
pesticide
manufacturer.
Potentially
affected
categories
and
entities
may
include,
but
are
not
limited
to:
 
Crop
production
(
NAICS
111)
 
Animal
production
(
NAICS
112)
 
Food
manufacturing
(
NAICS
311)
 
Pesticide
manufacturing
(
NAICS
32532)
This
listing
is
not
intended
to
be
exhaustive,
but
rather
provides
a
guide
for
readers
regarding
entities
likely
to
be
affected
by
this
action.
Other
types
of
entities
not
listed
in
the
table
could
also
be
affected.
The
North
American
Industrial
Classification
System
(
NAICS)
codes
have
been
provided
to
assist
you
and
others
in
determining
whether
or
not
this
action
might
apply
to
certain
entities.
If
you
have
questions
regarding
the
applicability
of
this
action
to
a
particular
entity,
consult
the
person
listed
under
FOR
FURTHER
INFORMATION
CONTACT.

B.
How
Can
I
Get
Copies
of
this
Document
and
Other
Related
Information?

1.
Docket.
EPA
has
established
an
official
public
docket
for
this
action
under
docket
identification
(
ID)
number
OPP
 
2002
 
0349.
The
official
public
docket
consists
of
the
documents
specifically
referenced
in
this
action,
any
public
comments
received,
and
other
information
related
to
this
action.
Although
a
part
of
the
official
docket,
the
public
docket
does
not
include
Confidential
Business
Information
(
CBI)
or
other
information
whose
disclosure
is
restricted
by
statute.
The
official
public
docket
is
the
collection
of
materials
that
is
available
for
public
viewing
at
the
Public
Information
and
Records
Integrity
Branch
(
PIRIB),
Rm.
119,
Crystal
Mall
#
2,
1921
Jefferson
Davis
Hwy.,
Arlington,
VA.
This
docket
facility
is
open
from
8:
30
a.
m.
to
4
p.
m.,
Monday
through
Friday,
excluding
legal
holidays.
The
docket
telephone
number
is
(
703)
305
 
5805.
2.
Electronic
access.
You
may
access
this
Federal
Register
document
electronically
through
the
EPA
Internet
under
the
``
Federal
Register''
listings
at
http://
www.
epa.
gov/
fedrgstr/.
An
electronic
version
of
the
public
docket
is
available
through
EPA's
electronic
public
docket
and
comment
system,
EPA
Dockets.
You
may
use
EPA
Dockets
at
http://
www.
epa.
gov/
edocket/
to
submit
or
view
public
comments,

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