Document ID: EPA-HQ-OPP-2002-0126-0001
Agency: epa
Document Type: Notice
Title: Notice of Filing a Pesticide Petition to Establish a Tolerance for a Certain Pesticide Chemical in or on 
Food
Posted Date: 2002-11-20T05:00Z

70073
Federal
Register
/
Vol.
67,
No.
224
/
Wednesday,
November
20,
2002
/
Notices
ADDRESSES:
The
meeting
will
be
held
at
Doubletree
Hotel,
300
Army
Navy
Drive,
Arlington,
VA
FOR
FURTHER
INFORMATION
CONTACT:
Georgia
McDuffie,
Field
and
External
Affairs
Division
(
7506c),
Office
of
Pesticide
Programs,
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460
 
0001;
telephone
number:
(
703)
605
 
0195;
fax
number:
(
703)
308
 
1850;
email
address:
mcduffie.
georgia@
epa.
gov.
or
Philip
H.
Gray,
SFIREG
Executive
Secretary,
P.
O.
Box
1249,
Hardwick,
VT
05843
 
1249;
telephone
number:
(
802)
472
 
6956;
fax
(
802)
472
 
6957;
e­
mail
address:
aapco@
plainfield.
bypass.
com.
SUPPLEMENTARY
INFORMATION:

I.
General
Information
A.
Does
this
Action
Apply
to
Me?
This
action
is
directed
to
the
public
in
general,
and
may
be
of
particular
interest
to
``
those
persons
who
are
or
may
be
required
to
conduct
testing
of
chemical
substances
under
the
Federal
Food,
Drug
and
Cosmetic
Act
(
FFDCA),
or
the
FIFRA''.
Since
other
entities
may
also
be
interested,
the
Agency
has
not
attempted
to
describe
all
the
specific
entities
that
may
be
affected
by
this
action.
If
you
have
any
questions
regarding
the
applicability
of
this
action
to
a
particular
entity,
consult
the
person
listed
under
FOR
FURTHER
INFORMATION
CONTACT.

B.
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
ID
number
OPP
 
2002
 
0306.
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
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.

II.
Tentative
Agenda:

1.
Committee
Business
Issues.
2.
Regional
Reports
&
Introduction
of
Issue
Papers/
Action
Items.
3.
Comments
to
the
Committee/
Open
Discussion
with
EPA
Senior
Managers
(
To
be
determined).
4.
Worker
Protection
Standard
(
WPS)
Program
Element
Review
Update.
5.
Non­
English/
Multiple
Language
Labels.
6.
Tribal
Pesticide
Program
Council
(
TPPC)/
Section
18s
&
other
Tribal
Issues.
7.
Update
on
Current
OPP
&
OECA
Activities.
8.
SFIREG
Issue
Paper
Status
Report.
9.
Closed
Session.
10.
Pesticide
Regulatory
Education
Program
(
PREP)
Briefing/
Issues.
11.
Soybean
Rust
Pest/
Section
18s
Requests.
12.
Status
(
SLA)
Label
Improvement
Project
Proposals
i.
e.
Mosquito
Products/
West
Nile
virus
Issues
13.
States
Label
Issue
Tracking
System
(
SLITS)
Update
14.
Certification
Training
Assessment
Group
(
CTAG)
Update
&
Discussion
15.
Issue
Papers/
Past
&
Present
List
of
Subjects
Environmental
protection,
Pesticide
and
pests.
Dated:
November
6,
2002.
Jay
Ellenberger,
Associate
Director,
Field
and
External
Affairs
Division,
Office
of
Pesticide
Programs.
[
FR
Doc.
02
 
29171
Filed
11
 
19
 
02;
8:
45
a.
m.]

BILLING
CODE
6560
 
50
 
S
ENVIRONMENTAL
PROTECTION
AGENCY
[
OPP
 
2002
 
0126;
FRL
 
7184
 
7]

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
a
pesticide
petition
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
 
0126,
must
be
received
on
or
before
December
20,
2002.

ADDRESSESS:
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.
To
ensure
proper
receipt
by
EPA,
it
is
imperative
that
you
identify
docket
ID
number
OPP
 
2002
 
0126
in
the
subject
line
on
the
first
page
of
your
response.

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

Categories
NAICS
codes
Examples
of
potentially
affected
entities
Industry
111
Crop
productionmption
112
Animal
production
311
Food
manufacturing
32532
Pesticide
manufacturing
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70074
Federal
Register
/
Vol.
67,
No.
224
/
Wednesday,
November
20,
2002
/
Notices
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.
To
determine
whether
you
or
your
business
may
be
affected
by
this
action,
you
should
examine
the
applicability
provisions
in
OPP
 
2002
 
0126.
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
 
0126.
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,
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.
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
feasable,
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.
1.
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
indentifying
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
 
0126.
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
 
0126.
In
contrast
to
EPA's
electronic
public
docket,
EPA's
email
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
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/
Vol.
67,
No.
224
/
Wednesday,
November
20,
2002
/
Notices
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
 
0126.
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
 
0126.
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
the
public
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
ckearly
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.
Offer
alternative
ways
to
improve
the
notice
or
collection
activity.
7.
Make
sure
to
submit
your
comments
by
the
deadline
in
this
document.
8.
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
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,
Pesticides
and
pests.

Dated:
October
27,
2002.
Debra
Edwards,
Acting
Director,
Registration
Division,
Office
of
Pesticide
Programs.

Summary
of
Petition
The
petitioner
summary
of
the
pesticide
petition
is
printed
below
as
required
by
section
408(
d)(
3)
of
the
FFDCA.
The
summary
of
the
petition
was
prepared
by
Nichino
America
Incorporated,
and
represents
the
view
of
Nichino
America
Incorporated.
The
petition
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.

Nichino
America
Incorporated
PP
1F6428
EPA
has
received
a
pesticide
petition
(
1F6428)
from
Nichino
America
Incorporated,
4550
New
Linden
Hill
Road,
Suite
501,
Wilmington,
DE
19808
proposing,
pursuant
to
section
408(
d)
of
the
FFDCA,
21
U.
S.
C.
346a(
d),
to
amend
40
CFR
part
180,
by
establishing
a
tolerances
for
combined
residues
of
pyraflufen­
ethyl
(
ethyl
2­
chloro­
5­(
4­
chloro­
5­
difluoromethoxy­
1­
methylpyrazol­
3­
yl)­
4­
fluorophenoxyacetate)
and
its
acid
metabolite,
E
 
1,
(
2­
chloro­
5­(
4­
chloro­
5­
difluoromethoxy­
1­
methylpyrazol­
3­
yl)­
4­
fluorophenoxyacetic
acid)
expressed
as
the
ester
equivalent
in
or
on
the
raw
agricultural
commodities
(
RACs)
derived
from
cotton;
undelinted
seed
at
0.05
parts
per
million
(
ppm);
and
gin
byproducts
at
1.5
ppm;
in
or
on
the
RAC
potato
at
0.02
ppm;
in
or
on
the
RACs
corn
grain,
corn
stover,
corn
forage,
soybean
seed,
soybean
forage,
and
soybean
hay
at
0.01
ppm;
wheat
forage,
wheat
hay,
wheat
straw,
and
wheat
grain
at
0.01
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.

A.
Residue
Chemistry
1.
Plant
metabolism.
The
qualitative
nature
of
the
residues
of
pyraflufenethyl
(
ET
 
751)
in
cotton,
potatoes,
corn,
soybeans,
and
wheat
is
adequately
understood.
The
metabolism
of
pyraflufen­
ethyl
has
been
studied
in
cotton,
wheat,
and
potato.
Metabolism
in
the
plant
involves
ester
hydrolysis,
de­
methylation
on
the
pyrazole
ring
and
further
degradation
of
the
phenoyxyacetate
moiety
to
bound
polar
metabolites.
The
nature
of
the
residue
is
adequately
understood
and
the
residues
of
concern
are
the
parent,
pyraflufenethyl
and
the
acid
metabolite,
E
 
1,
only.
2.
Analytical
method.
The
enforcement
analytical
method
utilizes
gas
chromatography/
mass
spectrophotometry
with
selected
ion
monitoring
for
detecting
and
measuring
levels
of
pyraflufen­
ethyl
and
the
acid
metabolite
with
a
general
limit
of
quantification
(
LOQ)
of
0.02
ppm
(
combined
E
 
1
and
parent).
This
method
allows
detection
of
residues
at
or
above
the
proposed
tolerances.
The
method
has
undergone
independent
laboratory
validation
as
required
by
PR
Notices
88
 
5
and
96
 
1.
3.
Magnitude
of
residues
in
crops
 
i.
Potato.
No
apparent
residues
of
pyraflufen­
ethyl
were
observed
in
potato
at
or
above
0.02
ppm
(
the
LOQ
VerDate
0ct<
31>
2002
16:
46
Nov
19,
2002
Jkt
200001
PO
00000
Frm
00033
Fmt
4703
Sfmt
4703
E:\
FR\
FM\
20NON1.
SGM
20NON1
70076
Federal
Register
/
Vol.
67,
No.
224
/
Wednesday,
November
20,
2002
/
Notices
for
the
analytical
method).
The
field
studies,
conducted
at
3x
the
highest
intended
label
use
rate,
in
16
trials
in
11
states,
clearly
support
the
proposed
tolerances
of
0.02
ppm
(
combined
E
 
1
and
parent).
No
detectable
residues
of
parent
or
the
acid
metabolite
were
observed
in
any
processed
potato
fraction
at
5x
the
maximum
proposed
application
rate
and
proposed
preharvest
interval
(
PHI)
in
a
field
study,
with
the
LOQ
of
0.02
ppm
(
combined
E
 
1
and
parent).
The
tolerance
that
is
being
proposed
for
the
use
of
pyraflufen­
ethyl
plus
the
acid
metabolite
on
potato
is
0.02
ppm.
ii.
Cotton.
Twelve
field
residue
trials
were
conducted
in
seven
different
states.
Applications
in
the
trials
were
3x
the
proposed
label
directions
for
use
and
at
the
proposed
PHI
of
7
days.
Analysis
of
the
treated
samples
showed
that
the
residues
of
pyraflufen­
ethyl
(
ethyl
2­
chloro­
5­(
4­
chloro­
5­
difluoromethoxy­
1­
methylpyrazol­
3­
yl)­
4­
fluorophenoxyacetate)
plus
its
acid
metabolite,
E
 
1,
(
2­
chloro­
5­(
4­
chloro­
5­
difluoromethoxy­
1­
methylpyrazol­
3­
yl)­
4­
fluorophenoxyacetic
acid)
expressed
as
the
ester
equivalent
at
the
exaggerated
rate,
were
below
the
proposed
tolerance
of
0.05
ppm
in
cotton
seed
at
the
proposed
labeled
PHI
in
all
samples.
No
residues
were
seen
in
the
processed
fractions
of
meal,
hull,
and
oil,
when
one
trial
was
run
in
a
typical
cotton
growing
area.
The
application
rate
for
this
processing
study
was
15x
the
maximum
proposed
application
rate
and
at
the
proposed
PHI.
This
indicates
that
there
is
no
concentration
of
pyraflufen­
ethyl
(
ethyl
2­
chloro­
5­(
4­
chloro­
5­
difluoromethoxy­
1­
methylpyrazol­
3­
yl)­
4­
fluorophenoxyacetate)
plus
its
acid
metabolite,
E
 
1,
(
2­
chloro­
5­(
4­
chloro­
5­
difluoromethoxy­
1­
methylpyrazol­
3­
yl)­
4­
fluorophenoxyacetic
acid),
expressed
as
the
ester
equivalent
in
any
of
the
processed
fractions.
Low
residues
seen
in
the
undelinted
cottonseed
were
consistent
with
the
magnitude
of
residue
trials.
Combined
residues
of
pyraflufen­
ethyl
(
ethyl
2­
chloro­
5­(
4­
chloro­
5­
difluoromethoxy­
1­
methylpyrazol­
3­
yl)­
4­
fluorophenoxyacetate)
plus
its
acid
metabolite,
E
 
1
(
2­
chloro­
5­(
4­
chloro­
5­
difluoromethoxy­
1­
methylpyrazol­
3­
yl)­
4­
fluorophenoxyacetic
acid)
in
cotton
gin
byproducts
from
applications
at
3x
the
proposed
application
rate
ranged
from
0.125
ppm
to
1.314
ppm,
and
averaged
0.035
ppm
from
applications
made
at
1x
the
proposed
application
rate.
The
proposed
tolerance
of
0.05
ppm
for
pyraflufen­
ethyl
(
ethyl
2­
chloro­
5­(
4­
chloro­
5­
difluoromethoxy­
1­
methylpyrazol­
3­
yl)­
fluorophenoxyacetate)
plus
its
acid
metabolite,
E
 
1,
(
2­
chloro­
5­(
4­
chloro­
5­
difluoromethoxy­
1­
methylpyrazol­
3­
yl)­
4­
fluorophenoxyacetic
acid)
in
cotton
seed
and
1.5
ppm
in
cotton
gin
byproducts
are
supported
by
the
field
residue
data.
iii.
Corn.
Three
exaggerated
rate
residue
trials
were
conducted
in
three
different
states
on
different
soil
types.
Applications
in
the
trials
were
5x
to
10x
the
proposed
label
directions
for
use
as
a
pre­
plant
burndown
herbicide.
Analysis
of
the
treated
samples
showed
zero
residues
of
pyraflufen­
ethyl
(
ethyl
2­
chloro­
5­(
4­
chloro­
5­
difluoromethoxy­
1­
methylpyrazol­
3­
yl)­
4­
fluorophenoxyacetate)
plus
its
acid
metabolite,
E
 
1,
(
2­
chloro­
5­(
4­
chloro­
5­
difluoromethoxy­
1­
methylpyrazol­
3­
yl)­
4­
fluorophenoxyacetic
acid)
expressed
as
the
ester
equivalent
at
the
exaggerated
rate.
The
LOQ
for
the
parent
and
the
metabolite
was
0.005
ppm
in
each
case.
Since
no
residues
were
observed
at
exaggerated
rates
in
RACs,
no
processing
studies
were
conducted.
iv.
Soybean.
Three
exaggerated
rate
residue
trials
were
conducted
in
three
different
states
on
different
soil
types.
Applications
in
the
trials
were
5x
to
10x
the
proposed
label
directions
for
use
as
a
pre­
plant
burndown
herbicide.
Analysis
of
the
treated
samples
showed
zero
residues
of
pyraflufen­
ethyl
(
ethyl
2­
chloro­
5­(
4­
chloro­
5­
difluoromethoxy­
1­
methylpyrazol­
3­
yl)­
4­
fluorophenoxyacetate)
plus
its
acid
metabolite,
E­
1,
(
2­
chloro­
5­(
4­
chloro­
5­
difluoromethoxy­
1­
methylpyrazol­
3­
yl)­
4­
fluorophenoxyacetic
acid)
expressed
as
the
ester
equivalent
at
the
exaggerated
rate.
The
LOQ
for
the
parent
and
the
metabolite
was
0.005
ppm
in
each
case.
Since
no
residues
were
observed
at
exaggerated
rates
in
RACs,
no
processing
studies
were
conducted.
v.
Wheat.
Three
exaggerated
rate
residue
trials
were
conducted
in
three
different
states
on
different
soil
types.
Applications
in
the
trials
were
5x
to
10x
the
proposed
label
directions
for
use
as
a
pre­
plant
burndown
herbicide.
Analysis
of
the
treated
samples
showed
zero
residues
of
pyraflufen­
ethyl
(
ethyl
2­
chloro­
5­(
4­
chloro­
5­
difluoromethoxy­
1­
methylpyrazol­
3­
yl)­
4­
fluorophenoxyacetate)
plus
its
acid
metabolite,
E
 
1,
(
2­
chloro­
5­(
4­
chloro­
5­
difluoromethoxy­
1­
methylpyrazol­
3­
yl)­
4­
fluorophenoxyacetic
acid)
expressed
as
the
ester
equivalent
at
the
exaggerated
rate.
The
LOQ
for
the
parent
and
the
metabolite
was
0.005
ppm
in
each
case.
Since
no
residues
were
observed
at
exaggerated
rates
in
RACs,
no
processing
studies
were
conducted.
4.
Magnitude
of
the
residue
in
animals.
 
i.
Ruminants.
The
maximum
dietary
burden
in
beef
and
dairy
cows
results
from
a
diet
comprised
of
undelinted
cottonseed,
cotton
meal,
cotton
hulls,
cotton
gin
byproducts,
potato
culls,
potato
waste,
and
from
grain
(
seed),
forage,
hay,
stover
(
fodder),
silage,
meal,
hulls,
straw,
aspirated
grain
fractions,
and
milled
byproducts
of
corn,
soybeans,
and
wheat
for
a
total
dietary
burden
that
is
significantly
lower
than
levels
that
would
require
the
proposal
of
tolerances
in
ruminants.
This
conclusion
is
based
on
exaggerated
rate
animal
metabolism
studies
carried
out
on
pyraflufen­
ethyl
and
its
significant
metabolites.
Therefore,
an
exemption
from
tolerances
in
milk,
meat,
and
meat
by­
products
under
40
CFR
180.6(
a)(
3)
and
(
b)
is
proposed
as
it
is
not
possible
to
establish
with
certainty
whether
finite
residues
will
be
incurred,
but
there
is
no
reasonable
expectation
of
finite
residues.
ii.
Poultry.
The
maximum
poultry
dietary
burden
results
from
a
diet
comprised
of
cotton
meal,
corn
grain,
corn
milled
byproducts,
soybean
seed,
soybean
meal,
soybean
hulls,
wheat
grain,
and
wheat
milled
byproducts
for
a
total
dietary
burden
that
is
significantly
lower
than
the
levels
that
would
require
the
proposal
of
tolerances
in
poultry.
This
conclusion
is
based
on
the
exaggerated
rate
metabolism
studies
carried
out
on
pyraflufen­
ethyl
and
its
acid
metabolite.
Therefore,
an
exemption
from
tolerances
in
poultry
meat,
meat
byproducts,
fat,
and
eggs
under
40
CFR
180.6(
a)(
3)
and
(
b)
is
proposed
as
it
is
not
possible
to
establish
with
certainty
whether
finite
residues
will
be
incurred,
but
there
is
no
reasonable
expectation
of
finite
residues.

B.
Toxicological
Profile
1.
Acute
toxicity.
Pyraflufen­
ethyl
technical
is
considered
to
be
nontoxic
(
toxicity
category
IV)
to
the
rat
by
the
oral
route
of
exposure.
In
an
acute
oral
toxicity
study
conducted
in
rats,
the
oral
LD50
value
for
technical
pyraflufen­
ethyl
was
determined
to
be
>
5,000
milligrams/
kilograms
body
weight
(
mg/
kg
bwt).
The
results
from
the
acute
dermal
toxicity
study
in
rabbits
indicate
that
pyraflufen­
ethyl
is
slightly
toxic
(
toxicity
category
III)
to
rabbits
by
the
dermal
route
of
exposure.
The
dermal
LD50
value
of
technical
pyraflufen­
ethyl
was
determined
to
be
>
2,000
mg/
kg
for
both
male
and
female
rabbits.
Pyraflufen­
ethyl
technical
is
considered
to
be
nontoxic
(
toxicity
category
IV)
to
the
rat
by
the
respiratory
route
of
exposure.
Inhalation
exposure
of
rats
to
pyraflufen­
ethyl
technical
resulted
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Notices
LC50
>
5.53
milligrams/
Liter
(
mg/
L)
(
analytical)
for
both
males
and
females.
Pyraflufen­
ethyl
technical
was
shown
to
be
non­
irritating
to
rabbit
skin
(
toxicity
category
IV).
Pyraflufen­
ethyl
technical
was
shown
to
be
slightly
irritating
to
rabbit
eyes
(
toxicity
category
III).
Application
of
technical
material
to
the
rabbit
eye
resulted
in
iris
and
conjunctival
irritation
from
1
to
24
hours,
which
was
clear
by
72
hours.
Based
on
the
results
of
a
dermal
sensitization
study,
pyraflufen­
ethyl
technical
is
not
considered
a
sensitizer
in
guinea
pigs.
2.
Genotoxicity.
Pyraflufen­
ethyl
technical
was
not
mutagenic
in
any
of
the
following
genotoxicity
studies.
Point
mutations
in
bacteria
in
an
Ames
study
with
Salmonella
typhimurium,
and
Escherichia
coli;
negative
in
chromosome
aberrations
in
vitro
human
lymphocytes,
and
in
the
mouse
micronucleus;
negative
for
DNA
repair
in
in
vitro
and
in
vivo
rat
liver
hepatocyte
assays
and
Bacillus
subtillis.
For
mammalian
gene
mutation,
in
one
in
vitro
mouse
lymphoma
mutation
assay,
no
evidence
of
mutagenicity
was
seen
in
the
absence
of
metabolic
activation.
With
S9
activation
at
levels
up
to
200
i 
g/
Liter,
equivocal
results
were
seen.
The
study
report
provided
no
criteria
for
positive
or
negative
responses.
When
this
in
vitro
study
was
repeated,
no
positive
or
equivocal
results
in
the
presence
of
activation
with
S9
at
levels
of
S9
up
to
350
i 
g/
Liter
were
seen.
These
levels
of
activation
were
greater
than
those
tested
in
the
earlier
study
and
both
small
and
large
colonies
were
counted.
The
overall
weight
of
evidence
indicates
that
pyraflufen­
ethyl
is
not
genotoxic.
3.
Reproductive
and
developmental
toxicity.
The
developmental
toxicity
study
in
rats
conducted
with
pyraflufenethyl
technical
showed
no
evidence
of
teratogenic
effects
in
fetuses
and
no
evidence
of
developmental
toxicity.
Thus,
pyraflufen­
ethyl
is
neither
a
developmental
toxicant
nor
a
teratogen
in
the
rat.
Pyraflufen­
ethyl
was
administered
by
gavage
during
gestation
and
showed
no
adverse
effects
on
dams
or
fetuses
at
dose
levels
of
0,
100,
300,
up
to
and
including
a
limit
dose
of
1,000
mg/
kg/
day.
The
maternal
and
developmental
toxicity
no
observe
adverse
effects
(
NOAELs)
were
both
>
1,000
mg/
kg/
day.
Results
from
a
developmental
toxicity
study
in
rabbits
conducted
with
pyrafluflen­
ethyl
technical
also
indicated
no
evidence
of
teratogenicity
or
developmental
toxicity.
Thus,
pyraflufen­
ethyl
technical
is
neither
a
developmental
toxicant
nor
a
teratogen
in
the
rabbit.
Rabbits
fed
pyraflufen­
ethyl
at
0,
20,
60,
or
150
mg/
kg/
day,
resulted
in
severe
maternal
toxicity,
including
lethality,
from
gastrointestinal
irritation
at
doses
of
60
and
150
mg/
kg/
day.
The
maternal
NOAEL
was
20
mg/
kg/
day.
The
NOAEL
for
the
offspring
was
60
mg/
kg/
day,
based
on
increased
post­
implantation
loss
observed
at
150
mg/
kg/
day.
Neither
the
rat
nor
the
rabbit
developmental
study
showed
evidence
of
unique
fetal
susceptibility
to
pyraflufen­
ethyl.
In
a
multigeneration
rat
reproduction
study
conducted
at
dietary
concentrations
of
0,
100,
1,000
and
10,000
ppm,
pyraflufen­
ethyl
had
no
effect
on
reproductive
parameters,
including
mating
indices,
fertility
index,
gestation
index,
duration
of
gestation,
numbers
of
implantation
sites,
numbers
and
morphology
of
epididymal
sperm,
and
estrous
cycle
at
any
dose
level.
Reproductive
performance
was
not
affected
by
pyraflufen­
ethyl
at
the
highest
dose
level
of
10,000
ppm
(
male
721
to
844
mg/
kg/
day
and
female
813
to
901
mg/
kg/
day).
The
pup
NOAEL
was
1,000
ppm,
based
on
decreased
body
weight
in
the
F1
and
F2
male
and
female
pups
on
day
17
at
the
10,000
ppm
dose
level.
Results
from
the
reproduction
study
and
the
developmental
toxicity
studies
conducted
with
pyraflufen­
ethyl
technical
show
no
increased
sensitivity
to
developing
offspring
as
compared
to
parental
animals,
because
the
NOAELs
for
growth
and
development
of
offspring
were
equal
to
or
greater
than
the
NOAELs
for
parental
or
maternal
toxicity.
4.
Subchronic
toxicity.
A
short­
term
(
28
 
day)
dermal
study
in
rabbits
was
conducted
with
pyraflufen­
ethyl
technical.
Pyraflufen­
ethyl
was
administered
dermally
to
rats
for
28
days
at
dose
levels
of
0,
300,
and
1000
mg/
kg
day.
Slight,
transient
erythema
was
observed
during
week
3
in
3
treated
males.
This
finding
was
not
doserelated
was
not
considered
to
be
adverse,
and
the
relationship
to
the
test
material
administration
was
unclear.
The
NOAEL
was
considered
to
be
1,000
mg/
kg/
day.
A
90
 
day
rat
feeding
study
was
conducted
at
dose
levels
of
0,
200,
1,000,
5,000,
or
15,000
ppm
pyraflufenethyl
The
NOAEL
in
this
study
was
considered
to
be
1,000
ppm
(
85.6
mg/
kg/
day
for
males
and
95.4
mg/
kg/
day
for
females),
based
on
slightly
increased
phosphorous
concentrations
in
females
and
hepatocytic
hypertrophy
in
males
at
5,000
ppm.
In
addition,
the
highest
dose
of
15,000
ppm
resulted
in
erythocyte
toxicity,
mitochondrial
changes
in
the
hepatocytes
and
the
presence
of
Kupffer
cells.
Also,
at
the
high
dose
level
increased
kidney
weights
in
males
and
increased
absolute
and
relative
spleen
weights
in
both
sexes
were
observed.
In
a
90
 
day
oral
toxicity
study
in
dogs,
pyraflufen­
ethyl
was
administered
via
capsule
at
dose
levels
of
0,
40,
200,
and
1,000
mg/
kg/
day.
No
treatmentrelated
findings
were
observed
and
the
NOAEL
was
determined
to
be
>
1,000
mg/
kg/
day.
At
the
limit
dose,
no
effects
in
body
weight
or
organ
weights,
clinical
chemistry,
hematology,
histopathology,
and
gross
pathology
were
observed.
To
determine
whether
the
test
material
was
absorbed
or
not,
plasma
was
collected
1
 
hour
after
administration
of
pyraflufen­
ethyl
during
week
13.
The
detection
of
2
major
degradation
products,
E
 
1
and
E
 
9,
confirmed
the
adsorption
and
gastrointestinal
and
systemic
exposure
to
pyraflufen­
ethyl.
5.
Chronic
toxicity.
A
1
 
year
chronic
dog
study
was
conducted
in
Beagle
dogs,
with
pyraflufen­
ethyl
administered
orally
by
gelatin
capsule
at
doses
of
0,
40,
200,
and
1,000
mg/
kg/
day.
There
were
no
mortalities
and
no
clinical
signs
of
toxicity.
No
treatmentrelated
effects
were
noted
on
body
weights,
food
consumption,
hematology
and
clinical
chemistry
parameters,
urinalysis,
ophthmoscopy,
and
organ
weights.
No
macrosopic
or
microscopic
lesions
were
noted.
The
NOAEL
was
>
1,000
mg/
kg/
day.
In
a
2
 
year
chronic
toxicity/
oncogenicity
study,
pyraflufen­
ethyl
was
administered
to
CD
rats
at
dietary
levels
of
0,
80,
400,
2,000,
or
10,000
ppm
(
equivalent
to
0,
3.4,
17.2,
86.7,
and
468.1
mg/
kg/
day
for
males
and
0,
4.4,
21.8,
111.5,
and
578.5
mg/
kg/
day
for
females).
Mortality
was
unaffected
by
treatment.
Body
weight
gain
was
statistically
significantly
depressed
for
those
rats
fed
10,000
ppm
at
1
 
year
compared
to
the
control.
Treatmentrelated
histopathology
was
seen
in
the
kidney,
liver,
and
bile
duct
at
10,
000
ppm.
At
2,000
and
10,000
ppm,
vacuoles
within
the
mitochondria
of
centriacinar
and
periacinar
hepatocytes
were
seen.
Effects
on
urine
volume,
urine
specific
gravity,
and
kidney
weights
were
seen
at
2,000
ppm
in
males.
The
NOAEL
was
17.2
mg/
kg/
day
for
males
and
21.8
mg/
kg/
day
for
females.
No
evidence
of
carcinogenicity
was
observed.
In
a
78
 
week
carcinogenicity
study,
mice
were
fed
pyraflufen­
ethyl
in
the
diet
at
levels
of
0,
200,
1,000,
or
5,000
ppm
(
equivalent
to
0,
21,
110,
547
mg/
kg/
day
for
males
and
0.
20,
98,
524
mg/
kg/
day
for
females).
An
maximum
tolerance
dose
(
MTD)
was
reached
at
1,000
ppm,
based
on
increased
liver
weight
and
liver
histopathological
changes
(
including
necrosis)
seen
at
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feeding
level.
In
the
highest
dose
group,
effects
of
pyraflufen­
ethyl
on
hematological
parameters
were
observed.
The
incidence
of
hepatocellular
adenoma
was
increased
in
animals
receiving
5,000
ppm,
compared
to
controls.
This
benign
tumor
was
likely
induced
by
the
adaptive
response
to
the
hepatocellular
degeneration
and
not
as
a
result
of
any
genotoxic
potential
of
pyraflufen­
ethyl.
In
addition
the
response
was
observed
only
at
a
dose
level
that
was
in
excess
of
an
MTD.
6.
Animal
metabolism.
The
qualitative
nature
of
the
residues
of
pyraflufenethyl
and
its
acid
metabolite,
E
 
1,
in
animals
is
adequately
understood.
Pyraflufen­
ethyl
is
rapidly
absorbed,
metabolized,
and
excreted
to
feces
and
urine,
with
greater
than
90%
of
the
administered
dose
excreted
within
24
hours
in
rats.
Based
on
metabolism
studies
with
goats,
hens,
and
rats,
there
is
no
reasonable
expectation
that
measurable
pyraflufen­
ethyl­
related
residues
will
occur
in
meat,
milk,
poultry,
or
eggs
from
the
proposed
use.
7.
Metabolite
toxicology.
No
toxicologically
significant
metabolites
were
detected
in
plant
or
animal
metabolism
studies
for
cotton
or
potatoes.
8.
Endocrine
disruption.
Chronic,
lifespan,
and
multigenerational
bioassays
in
mammals
and
acute
and
subchronic
studies
on
aquatic
organisms
and
wildlife
did
not
reveal
any
endocrine
effects
for
pyraflufen­
ethyl.
Any
endocrine
related
effects
would
have
been
detected
in
this
comprehensive
series
of
required
tests.
The
probability
of
any
such
effect
due
to
agricultural
uses
of
pyraflufen­
ethyl
is
negligible.

C.
Aggregate
Exposure
1.
Dietary
exposure.
The
potential
dietary
exposure
to
pyraflufen­
ethyl
has
been
calculated
from
the
proposed
tolerances
for
use
on
cotton,
and
potato.
While
tolerances
at
the
LOQ
are
proposed
for
corn,
soybean,
and
wheat,
it
is
concluded
that
there
is
no
potential
for
residues
in
these
crops
and
thus
no
dietary
exposure.
These
very
conservative
chronic
dietary
exposure
estimates
used
the
tolerance
value
for
all
the
raw
agricultural
commodities.
In
addition
these
estimates
assume
that
100%
of
the
cotton
and
potato
crops
contain
pyraflufen­
ethyl
residues.
i.
Food.
The
chronic
population
adjusted
dose
(
cPAD)
for
the
general
population,
based
on
residues
at
the
tolerance
levels
and
100%
of
potato
and
cotton
crops
treated
is
expected
to
be
approximately
0.000020
mg/
kg
bwt/
day
or
<
0.1%
of
the
reference
dose
(
RFD)
(
0.172
mg/
kg/
day).
Of
the
standard
subgroups
analyzed
by
the
dietary
exposure
evaluation
model
(
DEEM),
the
subgroup
with
the
highest
exposures
are
children
ages
1
to
6
years,
with
a
cPAD
of
0.000041
mg/
kg/
day
or
less
than
0.1%
of
the
RfD
mg/
kg/
day.
With
children
ages
7
to
12
with
exposures
of
0.000027
mg/
kg/
day,
the
exposure
is
less
than
0.1%
of
the
RfD.
ii.
Drinking
water.
As
a
screening
level
assessment
for
aggregate
exposure,
EPA
evaluates
drinking
water
level
of
comparison
(
DWLOC),
which
is
the
maximum
concentration
of
a
chemical
in
drinking
water
that
would
be
acceptable
in
terms
of
total
aggregate
exposure
to
that
chemical.
Based
on
the
chronic
RFD
of
0.172
mg/
kg/
day,
based
on
the
NOAEL
of
17.2
mg/
kg/
day
observed
in
the
chronic
rat
feeding
study
and
an
uncertainty
factor
(
UF)
of
100,
and
EPA's
default
factors
for
body
weight
and
drinking
water
consumption,
the
DWLOCs
have
been
calculated
to
assess
the
potential
dietary
exposure
from
residues
of
pyraflufenethyl
and
the
acid
metabolite,
E
 
1,
in
water.
For
the
adult
population,
the
chronic
DWLOC
was
35,086
parts
per
billion
(
ppb)
for
the
U.
S.
population,
and
for
children
10,172
ppb.
Chronic
drinking
water
exposure
analyses
were
calculated
using
EPA
screening
models,
screening
concentration
in
ground
water
(
SCIGROW
for
ground
water
and
generic
expected
environmental
concentration
(
GENEEC)
for
surface
water).
The
calculated
peak
GENEEC
value
for
the
acid
metabolite,
E
 
1,
the
major
degradation
of
pyraflufen­
ethyl
which
is
formed
within
an
hour
of
addition
to
a
water
solution
or
to
soil,
is
0.3321
ppb
and
the
SCI­
GROW
value
is
0.00024
ppb.
These
values
are
very
conservative
estimates
compared
to
the
values
derived
from
the
parent.
Nonetheless,
for
the
U.
S.
adult
population,
the
estimated
exposures
of
the
E
 
1
acid
metabolite
in
surface
water
and
ground
water
are
approximately
0.00094%
and
0.0000007%,
respectively,
of
the
DWLOC.
For
children,
the
estimated
exposures
of
the
acid
metabolite
in
surface
water
and
ground
water
are
approximately
0.0033%
and
0.000002%,
respectively
of
the
DWLOC.
Therefore,
the
exposures
to
drinking
water
from
the
acid
metabolite
are
negligible.
Based
on
the
dietary
and
drinking
water
assessments,
aggregate
exposure
to
residues
of
pyraflufen­
ethyl
and
the
acid
metabolite
in
food
and
water
can
be
considered
to
be
negligible.
2.
Non­
dietary
exposure.
It
is
being
proposed
that
pyraflufen­
ethyl
be
registered
in
the
following
non­
food
sites:
airports,
commercial
plants,
fence
lines,
farmyards,
and
farm
buildings;
storage
and
lumber
yards;
barrier
strips
and
firebreaks;
equipment
areas,
nurseries
and
ornamental
plantings;
established
ornamental
turf;
railroad,
roadside,
and
utility
rights­
of­
ways;
dry
ditches
and
ditch
banks;
fuel
tank
farms
and
pumping
stations;
other
similar
non­
crop
areas.
Exposure
to
pyraflufenethyl
for
the
mixer/
loader/
groundboom/
aerial
applicator
was
calculated
using
the
Pesticides
Handlers
Exposure
Database
(
PHED).
These
PHED
assessments
were
based
on
a
70
kg
operator
treating
80
acres
per
day
using
ground
boom
equipment
on
both
cotton
and
potato
fields;
an
operator
treating
1,200
acres
per
day
using
aerial
equipment
on
cotton
fields;
and
an
operator
treating
350
acres
per
day
using
aerial
equipment
on
potato
fields
(
EPA,
1999)
at
a
maximum
use
rate
of
0.009
pounds
active
ingredient
per
acre
for
potato
and
0.0045
pounds
active
ingredient
per
acre
for
cotton.
All
workers
were
assumed
to
be
wearing
long
pants
and
long­
sleeved
shirts.
Mixer­
loaders
were
assumed
to
be
wearing
gloves,
while
aerial
and
ground
applicators
and
flaggers
were
not
assumed
to
be
wearing
gloves.
Margins
of
exposure
(
MOE)
for
acute
and
shortterm
exposure
were
calculated
utilizing
a
dermal
and
inhalation
NOAEL
of
20
mg/
kg/
day,
based
on
maternal
toxicity
seen
in
the
rabbit
teratology
study
at
60
mg/
kg/
day,
and
assuming
100%
dermal
absorption.
MOEs
for
intermediate­
term
exposure
were
calculated
utilizing
a
dermal
endpoint
of
250
mg/
kg/
day,
the
systemic
NOAEL
from
the
28
 
day
dermal
toxicity
study
in
the
rat
with
the
2.5%
EC
formulation.
This
was
the
highest
dose
level
in
the
study
and
no
systemic
effects
were
seen
at
this
dose
level.
For
the
acute
inhalation
endpoint
we
used
86
mg/
kg/
day,
based
on
a
NOAEL
of
1,000
ppm
or
85.6
mg/
kg/
day
in
males
in
the
90
 
day
oral
feeding
study
in
the
rat.
The
combined
MOE
(
inhalation
plus
dermal)
for
pyraflufenethyl
was
greater
than
4,900
for
acute
and
short­
term
exposure,
while
the
intermediate­
term
total
MOEs
were
all
greater
than
56,000.
The
results
indicate
that
large
margins
of
safety
exist
for
the
proposed
uses
of
pyraflufen­
ethyl.

D.
Cumulative
Effects
Pyraflufen­
ethyl
belongs
to
the
protox
inhibitor
class
of
compounds,
and
chemically
is
a
3­
phenylpyrazole.
The
herbicidal
activity
of
protox
inhibitors
is
due
to
the
inhibition
of
protoporphyrinogen
IX
oxidase.
All
relevant
toxicological
data
has
been
provided
to
EPA.
Chemicals
with
a
similar
mode
of
action,
i.
e.,
the
protox
inhibitors,
have
different
chemical
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/
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67,
No.
224
/
Wednesday,
November
20,
2002
/
Notices
structures
compared
to
pyraflufen­
ethyl.
Although
other
protox
inhibitors
have
a
similar
herbicidal
mode
of
action,
there
is
no
information
available
to
suggest
that
these
compounds
exhibit
a
similar
toxicity
profile
in
the
mammalian
system.
We
are
aware
of
no
information
to
indicate
or
suggest
that
pyraflufenethyl
has
any
toxic
effects
on
mammals
that
would
be
cumulative
with
those
of
any
other
chemical.
Since
pyraflufenethyl
is
relatively
non­
toxic,
cumulative
effects
of
residues
and
other
compounds
are
not
anticipated.
Therefore,
for
the
purposes
of
this
Food
Quality
Protection
Act
(
FQPA)
document,
there
should
be
no
consideration
of
cumulative
risk
that
would
require
assessment.

E.
Safety
Determination
1.
U.
S.
population.
Based
on
the
chronic
toxicity
data,
the
RfD
for
pyraflufen­
ethyl
is
considered
to
be
0.172
mg/
kg/
day.
This
value
is
based
on
the
NOAEL
of
17.2
mg/
kg/
day
observed
in
the
chronic
rat
feeding
study
and
a
safety
(
uncertainty)
factor
of
100,
the
worse
case
estimate
of
chronic
dietary
exposure
of
pyraflufen­
ethyl
from
cotton,
potatoes,
corn,
or
soybean
will
utilize
less
than
0.1%
of
the
RfD
for
the
general
U.
S.
population.
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.
The
complete
and
reliable
toxicity
data
and
the
conservative
chronic
exposure
assumptions
support
the
conclusion
that
there
is
a
reasonable
certainty
of
no
harm
from
dietary
(
food)
exposure
to
pyraflufen­
ethyl
and
the
acid
metabolite
residues.
Moreover,
as
exposure
to
residues
of
pyraflufen­
ethyl
and
the
acid
metabolite
via
water
is
negligible,
there
is
a
reasonable
certainty
of
no
harm
from
aggregate
exposure
to
pyraflufenethyl
and
the
acid
metabolite
residues.
2.
Infants
and
children.
The
conservative
estimates,
as
described
above,
indicate
that
chronic
dietary
exposure
of
pyraflufen­
ethyl
and
the
acid
metabolite
from
cotton
and
potato
will
utilize
less
than
0.1%
of
the
RfD
for
non­
nursing
infants,
less
than
0.1%
of
the
RfD
for
children
ages
1
to
6;
and
less
than
0.1%
of
the
RfD
for
all
populations
examined.
No
developmental,
reproductive,
or
fetotoxic
effects
were
noted
at
the
highest
doses
of
pyraflufenethyl
tested
in
guideline
reproductive
or
developmental
toxicity
studies.
Based
on
the
current
toxicological
data
requirements,
the
data
base
relative
to
prenatal
and
postnatal
effects
for
children
is
complete,
valid
and
reliable.
Results
from
the
teratology
studies
and
the
2
 
generation
reproduction
study
support
NOAELs
for
fetal/
developmental
effects
or
reproductive/
offspring
effects,
respectively,
equivalent
to
the
highest
concentrations
tested.
As
such,
there
is
no
increased
sensitivity
of
infants
and
children
to
residues
of
pyraflufen­
ethyl.
Therefore,
an
additional
safety
(
uncertainty)
factor
is
not
warranted,
and
the
RfD
of
0.172
mg/
kg/
day,
which
utilizes
a
100
 
fold
safety
factor,
is
appropriate
to
assure
a
reasonable
certainty
of
no
harm
to
infants
and
children.

F.
International
Tolerances
There
is
no
Codex
maximum
residue
level
established
for
residues
of
pyraflufen­
ethyl
and
the
acid
metabolite
on
any
crops.
[
FR
Doc.
02
 
29330
Filed
11
 
19
 
02;
8:
45
am]

BILLING
CODE
6560
 
50
 
S
ENVIRONMENTAL
PROTECTION
AGENCY
[
FRL
 
7410
 
5]

Notice
of
Availability
of
Enforcement
and
Compliance
History
Online
Web
Site
for
60­
Day
Comment
Period
AGENCY:
Environmental
Protection
Agency
(
EPA).
ACTION:
Notice
of
information
availability
and
request
for
comments.

SUMMARY:
The
Office
of
Compliance
(
OC),
within
EPA's
Office
of
Enforcement
and
Compliance
Assurance
(
OECA),
announces
the
availability
of
and
invites
comments
on
its
new
Web
site,
Enforcement
and
Compliance
History
Online
(
ECHO),
which
contains
searchable,
facility­
level
enforcement
and
compliance
information.
DATES:
Comments
must
be
submitted
no
later
than
January
21,
2003.
ADDRESSES:
The
Web
site
is
available
at
http://
www.
epa.
gov/
echo.
Comments
may
be
submitted
to
echo@
epa.
gov
as
a
Word
or
WordPerfect
file
or
mailed
to
Rebecca
Kane,
Environmental
Protection
Agency,
Office
of
Enforcement
and
Compliance
Assurance,
MC
2222A,
1200
Pennsylvania
Avenue
NW.,
Washington,
DC
20460.
Specific
data
errors
should
be
submitted
using
the
error
correction
process
on
the
ECHO
site.

FOR
FURTHER
INFORMATION
CONTACT:
Rebecca
Kane
at
kane.
rebecca@
epa.
gov
or
(
202)
564
 
5960.

SUPPLEMENTARY
INFORMATION:

I.
ECHO
Background
EPA
is
committed
to
public
access
to
environmental
information
and
has
worked
to
develop
a
format
for
providing
Internet
access
to
facilitylevel
compliance
and
enforcement
information
contained
in
core
EPA
data
systems.
Though
the
data
included
within
ECHO
previously
were
available
to
the
public
primarily
through
Freedom
of
Information
Act
requests,
the
information
was
not
available
in
a
searchable
Web
format.
This
new
egovernment
initiative
makes
it
much
easier
for
the
public
to
obtain
these
data
records
on
the
Internet.
EPA
has
worked
with
State
governments
to
develop
the
content
of
the
site
and
ensure
accurate
data
and
has
pilot
tested
Internet
access.
A
Joint
EPA­
State
Enforcement
and
Compliance
Public
Access
Workgroup
developed
the
template
for
the
type,
sources,
and
amount
of
data
to
be
included
within
ECHO.
This
workgroup,
developed
in
partnership
with
the
Environmental
Council
of
the
States
(
ECOS),
made
its
recommendations
in
June
2000.
EPA
has
field
tested
the
approach
and
the
data
through:
the
Sector
Facility
Indexing
Project
(
http://
www.
epa.
gov/
sfipmtn1/),
which
shows
data
for
a
limited
number
of
industrial
sectors,
and
a
four­
State
pilot
in
the
Pacific
Northwest
(
http://
www.
epa.
gov/
idea/
region10).
Public
feedback
and
lessons
learned
from
these
projects
contributed
to
the
development
of
the
ECHO
site.
To
prepare
for
launch
of
ECHO,
EPA
and
the
States
conducted
a
comprehensive
data
review
to
ensure
high
quality
information.
ECHO
also
includes
on
the
site
an
online
error
reporting
process
that
allows
users
to
alert
EPA
and
the
States
to
possible
errors.
This
notice
announces
a
60­
day
comment
period,
which
is
being
provided
to
give
interested
parties,
particularly
those
responsible
for
facilities
included
within
the
database,
the
opportunity
to
review
ECHO's
content,
design,
and
accuracy
of
data.

II.
ECHO
Data
ECHO
provides
integrated
compliance
and
enforcement
information
for
approximately
800,000
regulated
facilities
nationwide.
The
site
allows
users
to
find
facility­
level
inspection,
violation,
enforcement
action,
and
penalty
information
for
the
past
two
years.
Facilities
regulated
under
the
Clean
Air
Act
(
CAA)
Stationary
Source
Program,
Clean
Water
Act
(
CWA)
National
Pollutant
Elimination
Discharge
System
(
NPDES),
and
Resource
Conservation
and
Recovery
Act
(
RCRA)
are
included.
ECHO
reports
provide
a
snapshot
of
a
facility's
environmental
record,
showing
dates
and
types
of
violations,
as
well
as
the
State
or
Federal
government's
response.

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