Document ID: EPA-HQ-OPP-2002-0322-0001
Agency: epa
Document Type: Notice
Title: Fosetyl-Al; Notice of Filing a Pesticide Petition to Establish a Tolerance for a Certain Pesticide
Chemical in or on Food
Posted Date: 2003-01-02T05:00Z

103
Federal
Register
/
Vol.
68,
No.
1
/
Thursday,
January
2,
2003
/
Notices
Commission
relating
to
the
merits
of
an
issue
that
may
affect
the
responsibilities
of
a
particular
resource
agency,
they
must
also
serve
a
copy
of
the
document
on
that
resource
agency.
j.
Description
of
Project:
The
proposed
project,
using
the
Corps'
existing
Kentucky
Lock
and
Dam
No.
11
and
Reservoir,
would
consist
of:
(
1)
Six
proposed
50­
foot­
long,
8­
foot­
diameter
steel
penstocks,
(
2)
a
proposed
powerhouse
containing
six
generating
units
with
a
combined
installed
capacity
of
8
megawatts,
(
3)
a
proposed
300­
foot­
long,
14.7
 
kv
transmission
line,
and
(
4)
appurtenant
facilities.
The
project
would
operate
in
a
run­
of­
river
mode
and
would
have
an
average
annual
generation
of
49
GWh.
k.
This
filing
is
available
for
review
at
the
Commission
in
the
Public
Reference
Room
or
may
be
viewed
on
the
Commission's
Web
site
at
http://
www.
ferc.
gov
using
the
``
FERRIS''
link.
Enter
the
docket
number
excluding
the
last
three
digits
in
the
docket
number
field
to
access
the
document.
For
assistance,
call
toll­
free
1
 
866
 
208
 
3678
or
e­
mail
ferconlinesupport@
ferc.
gov.
For
TTY,
call
(
202)
502
 
8659.
A
copy
is
also
available
for
inspection
and
reproduction
at
the
applicant's
address
in
item
g
above.
l.
Competing
Preliminary
Permit
 
Anyone
desiring
to
file
a
competing
application
for
preliminary
permit
for
a
proposed
project
must
submit
the
competing
application
itself,
or
a
notice
of
intent
to
file
such
an
application,
to
the
Commission
on
or
before
the
specified
comment
date
for
the
particular
application
(
see
18
CFR
4.36).
Submission
of
a
timely
notice
of
intent
allows
an
interested
person
to
file
the
competing
preliminary
permit
application
no
later
than
30
days
after
the
specified
comment
date
for
the
particular
application.
A
competing
preliminary
permit
application
must
conform
with
18
CFR
4.30(
b)
and
4.36.
m.
Competing
Development
Application
 
Any
qualified
development
applicant
desiring
to
file
a
competing
development
application
must
submit
to
the
Commission,
on
or
before
a
specified
comment
date
for
the
particular
application,
either
a
competing
development
application
or
a
notice
of
intent
to
file
such
an
application.
Submission
of
a
timely
notice
of
intent
to
file
a
development
application
allows
an
interested
person
to
file
the
competing
application
no
later
than
120
days
after
the
specified
comment
date
for
the
particular
application.
A
competing
license
application
must
conform
with
18
CFR
4.30(
b)
and
4.36.
n.
Notice
of
Intent
 
A
notice
of
intent
must
specify
the
exact
name,
business
address,
and
telephone
number
of
the
prospective
applicant,
and
must
include
an
unequivocal
statement
of
intent
to
submit,
if
such
an
application
may
be
filed,
either
a
preliminary
permit
application
or
a
development
application
(
specify
which
type
of
application).
A
notice
of
intent
must
be
served
on
the
applicant(
s)
named
in
this
public
notice.
o.
Proposed
Scope
of
Studies
under
Permit
 
A
preliminary
permit,
if
issued,
does
not
authorize
construction.
The
term
of
the
proposed
preliminary
permit
would
be
36
months.
The
work
proposed
under
the
preliminary
permit
would
include
economic
analysis,
preparation
of
preliminary
engineering
plans,
and
a
study
of
environmental
impacts.
Based
on
the
results
of
these
studies,
the
Applicant
would
decide
whether
to
proceed
with
the
preparation
of
a
development
application
to
construct
and
operate
the
project.
p.
Comments,
Protests,
or
Motions
to
Intervene
 
Anyone
may
submit
comments,
a
protest,
or
a
motion
to
intervene
in
accordance
with
the
requirements
of
Rules
of
Practice
and
Procedure,
18
CFR
385.210,
.211,
.214.
In
determining
the
appropriate
action
to
take,
the
Commission
will
consider
all
protests
or
other
comments
filed,
but
only
those
who
file
a
motion
to
intervene
in
accordance
with
the
Commission's
Rules
may
become
a
party
to
the
proceeding.
Any
comments,
protests,
or
motions
to
intervene
must
be
received
on
or
before
the
specified
comment
date
for
the
particular
application.
q.
Filing
and
Service
of
Responsive
Documents
 
Any
filings
must
bear
in
all
capital
letters
the
title
``
COMMENTS'',
``
NOTICE
OF
INTENT
TO
FILE
COMPETING
APPLICATION'',
``
COMPETING
APPLICATION'',
``
PROTEST'',
or
``
MOTION
TO
INTERVENE'',
as
applicable,
and
the
Project
Number
of
the
particular
application
to
which
the
filing
refers.
Any
of
the
above­
named
documents
must
be
filed
by
providing
the
original
and
the
number
of
copies
provided
by
the
Commission's
regulations
to:
The
Secretary,
Federal
Energy
Regulatory
Commission,
888
First
Street,
NE.,
Washington,
DC
20426.
An
additional
copy
must
be
sent
to
Director,
Division
of
Hydropower
Administration
and
Compliance,
Federal
Energy
Regulatory
Commission,
at
the
above­
mentioned
address.
A
copy
of
any
notice
of
intent,
competing
application
or
motion
to
intervene
must
also
be
served
upon
each
representative
of
the
Applicant
specified
in
the
particular
application.
r.
Agency
Comments
 
Federal,
state,
and
local
agencies
are
invited
to
file
comments
on
the
described
application.
A
copy
of
the
application
may
be
obtained
by
agencies
directly
from
the
Applicant.
If
an
agency
does
not
file
comments
within
the
time
specified
for
filing
comments,
it
will
be
presumed
to
have
no
comments.
One
copy
of
an
agency's
comments
must
also
be
sent
to
the
Applicant's
representatives.

Linwood
A.
Watson,
Jr.,
Deputy
Secretary.
[
FR
Doc.
02
 
33057
Filed
12
 
31
 
02;
8:
45
am]

BILLING
CODE
6717
 
01
 
P
ENVIRONMENTAL
PROTECTION
AGENCY
[
OPP
 
2002
 
0322;
FRL
 
7282
 
5]

Fosetyl­
Al;
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
 
0322,
must
be
received
on
or
before
February
3,
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:
Sidney
Jackson,
Registration
Division
(
7505C),
Office
of
Pesticide
Programs,
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460
 
0001;
telephone
number:
(
703)
305
 
7610;
e­
mail
address:
jackson.
sidney@
epa.
gov.

SUPPLEMENTARY
INFORMATION:

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

You
may
be
potentially
affected
by
this
action
if
you
are
an
agricultural
producer,
food
manufacturer,
or
pesticide
manufacturer.
Potentially
affected
categories
and
entities
may
incude,
but
are
not
limited
to:
 
Crop
production
(
NAICS
Industry
111)
 
Animal
production
(
NAICS
112)

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104
Federal
Register
/
Vol.
68,
No.
1
/
Thursday,
January
2,
2003
/
Notices
 
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
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
any
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
ID
number
OPP
 
2002
 
0322.
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.
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
 
0322.
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
 
0322.
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
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02JAN1.
SGM
02JAN1
105
Federal
Register
/
Vol.
68,
No.
1
/
Thursday,
January
2,
2003
/
Notices
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
 
0322.
3.
By
hand
delivery
or
courier.
Deliver
your
comments
to:
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
 
0322.
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
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.
Offer
alternative
ways
to
improve
the
notice
or
collection
activity.
7.
Make
sure
to
submit
your
comments
by
the
deadline
in
this
notice.
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
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
Petition
The
petitioner's
summary
of
the
pesticide
petition
is
printed
below
as
required
by
the
FFDCA
section
408(
d)(
3).
The
summary
of
the
petition
was
prepared
by
Bayer
CropScience
Company
and
represents
the
view
of
the
company.
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.
PP
2E6366
EPA
has
received
a
pesticide
petition
(
PP
2E6366)
from
the
Interregional
Research
Project
Number
4
(
IR­
4),
New
Jersey
Agricultural
Experiment
Station,
Rutgers
University,
New
Brunswick,
NJ
08903
proposing,
pursuant
to
section
408(
d)
of
the
FFDCA,
21
U.
S.
C.
346a(
d),
to
amend
40
CFR
180.415
by
establishing
a
tolerance
for
residues
of
the
fungicide,
fosetyl­
al
(
aluminum
tris
O­
ethylphosphonate),
in
or
on
the
raw
agricultural
commodity
onion,
green,
at
10
parts
per
million
(
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
metabolism
of
fosetyl­
al
in
plants
is
adequately
understood.
Adequate
data
on
the
nature
of
the
residues
in
plants,
including
identification
of
major
metabolites
and
degradates
of
fosetyl­
al,
are
available.
Radiolabeled
studies
on
the
uptake,
translocation
and
metabolism
in
plants
show
that
the
chemical
proceeds
through
hydrolytic
cleavage
of
the
ethyl
ester.
The
major
residues
are
fosetyl­
al,
phosphorus
acid,
and
ethanol.
The
tolerances
are
established
for
the
parent
only,
that
is
fosetyl­
al.
2.
Analytical
method.
Adequate
methods
are
available
for
enforcement
purposes.
There
are
two
analytical
methods
acceptable
for
determining
residues
of
fosetyl­
al
in
plants:
a
gas
chromatography
method
is
available
for
enforcement
of
tolerance
in
pineapple
and
is
listed
as
Method
I
in
Pesticide
Analytical
Manual
(
PAM),
Vol.
II;
a
gas
chromatography/
phosphorus
specific
flame
photometric
detector
(
FPD­
P)
method
(
Rhone­
Poulenc
Method
No.
163)
for
citrus
has
undergone
a
successful
method
tryout
on
oranges
and
has
been
sent
to
the
Food
and
Drug
Administration
(
FDA)
for
inclusion
in
PAM
as
Method
II.
3.
Magnitude
of
residues.
Magnitude
of
residue
data
on
green
onions
were
collected
form
field
trials
conducted
in
Texas
(
Region
6)
and
California
(
Region
10).
Each
treated
plot
received
seven
foliar
broadcast
applications
of
the
test
substance
at
a
rate
of
approximately
4.0
pounds
active
ingredient/
acre
(
lb
a.
i./
acre),
for
a
total
of
approximately
28.0
lb
a.
i./
acre.
All
applications
were
made
6
to
8
days
apart,
and
marketable
green
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02JAN1.
SGM
02JAN1
106
Federal
Register
/
Vol.
68,
No.
1
/
Thursday,
January
2,
2003
/
Notices
onions
were
collected
2
to
3
days
following
the
final
application.
Residues
of
fosetyl­
al
in
green
onions
ranged
from
0.39
ppm
to
7.75
ppm.

B.
Toxicological
Profile
EPA
has
evaluated
the
available
fosetyl­
al
toxicity
data
and
considered
their
validity,
completeness,
and
reliability
as
well
as
the
relationship
of
the
results
of
the
studies
to
human
risk.
EPA
has
also
considered
available
information
concerning
the
variability
of
the
sensitivities
of
major
identifiable
subgroups
of
consumers,
including
infants
and
children.
The
nature
of
the
toxic
effects
caused
by
fosetyl­
al
is
discussed
in
the
Federal
Register
of
August
18,
2000
(
65
FR
50431)
(
FRL
 
6599
 
4),
as
well
as
the
no
observed
adverse
effect
level
(
NOAEL),
and
the
lowest
observed
adverse
effect
level
(
LOAEL)
from
the
toxicity
studies
reviewed.
Please
refer
to
this
document
should
you
desire
detailed
toxicological
information
on
fosetyl­
al.
1.
Carcinogenicity.
Long­
term
feeding
studies
were
conducted
with
technical
grade
fosetyl­
al
in
mice
and
rats
and
with
monosodium
phosphite,
the
primary
urinary
metabolite
of
fosetyl­
al,
in
rats.
These
studies,
in
addition
to
a
mechanistic
study
in
rats,
are
described
below:
i.
Rat.
Fosetyl­
al
was
administered
via
admixture
in
the
diet
to
CD
rats
at
target
levels
of
0,
2,000,
8,000,
and
30,000/
40,000
ppm
for
approximately
2
years.
After
2
weeks
at
40,000
ppm,
this
dietary
level
was
reduced
to
30,000
ppm
due
to
the
occurrence
of
red
coloration
of
the
urine
and
a
decrease
in
body
weight
gain.
Although,
these
findings
were
no
longer
apparent
after
week
2,
analytical
verification
of
dietary
levels
revealed
that
the
highest
dietary
level
ranged
from
approximately
38,000
to
61,000
ppm
during
the
first
32
weeks
of
the
study.
Calculi
in
the
urinary
bladder
were
observed
for
several
male
and
female
rats
at
30,000/
40,000
ppm.
Microscopic
examination
revealed
transitional
cell
carcinomas
and
papillomas
in
the
urinary
bladders
of
high
dose
males.
In
addition,
a
statistically
significant
increase
in
adrenal
pheochromocytomas
(
benign
and
malignant
combined)
was
observed
in
males
at
8,000
and
30,000/
40,000
ppm.
The
adrenal
slides
were
independently
reread
by
two
consulting
pathologists
who
found
no
significant
dose­
related
increases
in
the
incidence
of
pheochromocytomas
or
hyperplasia.
The
NOAEL
for
fosetyl­
al
in
the
chronic
rat
study
was
8,000
ppm.
A
subsequent
mechanistic
study
in
rats
conducted
with
dietary
levels
of
8,000,
30,000
and
50,000
ppm
demonstrated
that
the
massive
doses
of
30,000
and
50,000
ppm
fosetyl­
al
alter
calcium/
phosphorous
homeostasis
resulting
in
severe
acute
renal
injury,
similar
to
that
observed
in
the
chromic
rat
study,
and
the
formation
of
calculi
in
kidneys,
ureters,
and
bladder.
Under
conditions
of
chronic
exposure,
these
effects
could
lead
to
the
formation
of
bladder
tumors
as
seen
in
the
chronic
rat
study.
At
8,000
ppm,
no
evidence
of
renal
injury
was
observed,
a
result
consistent
with
the
absence
of
bladder
tumors.
Thus,
the
bladder
tumors
induced
by
fosetyl­
al
were
the
result
of
acute
renal
injury
followed
by
a
chronic
toxic
reaction
rather
than
a
true
carcinogenic
effect.
An
carcinogenicity
study
in
rats
was
conducted
with
monosodium
phosphite
administered
via
dietary
mixture
at
levels
of
2,000,
8,000,
and
32,000
ppm.
No
evidence
of
carcinogenicity
was
observed
in
this
study.
ii.
Mouse.
A
2
 
year
feeding/
carcinogenicity
study
was
conducted
in
mice
fed
diets
containing
fosetyl­
al
at
0,
2,500,
10,000,
or
20,000/
30,000
ppm.
The
20,000
ppm
dose
was
increased
to
30,000
ppm
during
week
19
of
the
study.
The
NOAEL
for
all
effects
was
20,000/
30,000
ppm
(
3,000/
4,500
milligrams/
kilogram
(
mg/
kg/
day)).
There
were
no
carcinogenic
effects
observed
under
the
conditions
of
this
study.
iii.
EPA's
Carcinogenicity
Peer
Review
Committee
(
CPRC)
concluded
in
their
report
of
June
29,
1993
that
the
pesticidal
use
of
fosetyl­
al
is
unlikely
to
pose
a
carcinogenic
hazard
for
humans
given
that:
(
a)
Tumors
develop
in
rats
under
extreme
conditions
that
are
unlikely
to
be
achieved
other
than
under
laboratory
conditions
(
at
a
dose
in
excess
of
the
EPA
dose
limit
for
carcinogenicity
studies);
(
b)
tumors
in
rats
are
believed
to
develop
only
at
doses
that
produce
stones;
(
c)
human
dietary
exposure
to
fosetyl­
al
is
only
about
one­
500,000th
of
the
NOAEL
for
stone
formation
in
the
rat
(
the
most
sensitive
experimental
model);
and
(
d)
the
dose
of
fosetyl­
al
which
can
be
absorbed
dermally
by
applicators
is
also
probably
too
low
to
result
in
stone
formation.
Therefore,
a
cancer
dietary
exposure
analysis
for
fosetyl­
al
is
not
performed.
2.
Animal
metabolism.
Rat
metabolism
studies
showed
that
most
of
the
radiolabel
rapidly
appeared
in
exhaled
carbon
dioxide.
There
was
also
some
radiolabel
excreted
in
the
urine
as
phosphite,
along
with
a
smaller
amount
as
the
unchanged
parent
compound.
It
appears
that
fosetyl­
al
is
essentially
completely
absorbed
after
ingestion
and
extensively
hydrolyzed
to
carbon
dioxide
which
is
exhaled.
The
phosphite
is
excreted
in
the
urine
without
further
oxidation
to
phosphate.
Aluminum
does
not
appear
to
be
absorbed
to
a
significant
extent
from
the
gastrointestinal
tract.
3.
Metabolite
toxicology.
There
are
no
metabolites
of
toxicological
concern.
The
tolerances
are
established
for
the
parent
only,
that
is
fosetyl­
al.
4.
Endocrine
disruption.
No
evidence
of
estrogenic
or
androgenic
effects
were
noted
in
any
study
with
fosetyl­
al.
No
adverse
effects
on
mating
or
fertility
indices
and
gestation,
live
birth,
or
weaning
indices
were
noted
in
a
threegeneration
rat
reproduction
study
at
doses
well
above
EPA's
limit
of
1,000
mg/
kg/
day.
Therefore,
Bayer
CropScience
concludes
that
fosetyl­
al
does
not
have
any
effect
on
the
endocrine
system.

C.
Aggregate
Exposure
1.
Dietary
exposure.
EPA
has
established
the
chronic
reference
dose
(
RfD)
for
fosetyl­
al
at
2.5
mg/
kg/
day.
This
reference
dose
(
RfD)
is
based
on
a
NOAEL
of
250
mg/
kg/
day
from
a
2
 
year
feeding
study
in
dogs
and
the
use
of
a
100
fold
safety
factor
to
account
for
interspecies
and
intraspecies
differences.
No
appropriate
endpoint
attributable
to
a
single
dose
exposure
was
identified
in
oral
toxicity
studies.
Therefore,
an
acute
RfD
was
not
established
and
there
is
no
expectation
of
acute
risk.
Since
no
dermal
or
systemic
toxicity
was
seen
at
the
limit
dose
following
repeated
dermal
applications
in
the
21
 
day
toxicity
study
using
rats,
no
endpoint
value
was
calculated
for
short­
and
intermediateterm
exposure
and
risk.
The
Agency
has
concluded
that
fosetyl­
al
is
unlikely
to
pose
a
carcinogenic
hazard
to
humans.
Therefore,
a
cancer
exposure
and
risk
assessment
is
not
appropriate.
i.
Food.
For
all
currently
registered
uses
of
fosetyl­
al,
chronic
food
exposure
for
various
subgroups
of
the
U.
S.
population
was
estimated
by
EPA
through
the
use
of
the
Dietary
Exposure
Evaluation
Model
(
DEEM)
software.
The
DEEM
analysis
evaluated
the
individual
food
consumption
as
reported
by
respondents
in
the
USDA
1989
 
1992
nationwide
continuing
surveys
of
food
intake
by
individuals.
As
the
risk
estimate
was
low
for
even
the
most
highly
exposed
subpopulation,
no
anticipated
residues
were
used.
One
hundred
percent
crop
treated
and
tolerance
level
residues
were
assumed
for
all
crops.
EPA
has
concluded
that
exposure
to
fosetyl­
al
from
food
utilizes
4.0%
of
the
chronic
population
adjusted
dose
(
cPAD)
for
the
U.
S.
population,
5%
of
the
cPAD
for
infants,
and
8%
of
the
cPAD
for
children
1
 
6
years
old,
the
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107
Federal
Register
/
Vol.
68,
No.
1
/
Thursday,
January
2,
2003
/
Notices
subpopulation
at
greatest
exposure.
Based
on
the
results
of
this
conservative
analysis,
exposure
to
fosetyl­
al
residues
from
the
proposed
uses
is
expected
to
be
minimal.
Bayer
CropScience
concludes
that
dietary
exposure
to
fosetyl­
al
resulting
from
the
currently
registered
uses
and
the
proposed
use
of
the
product
will
be
well
below
the
Agency's
level
of
concern.
ii.
Drinking
water.
The
potential
for
ground
water
and/
or
surface
water
contamination
by
fosetyl­
al
and
its
degradates
is
expected
to
be
very
low,
in
most
cases,
due
to
the
rapid
degradation
of
the
compound
in
soil
to
non­
toxic
degradates
under
both
aerobic
and
anaerobic
conditions.
Under
aerobic
laboratory
conditions,
the
half­
life
of
fosetyl­
al
is
between
1
and
1.5
hours
in
loamy
sand,
silt
loam,
and
clay
loam
and
20
minutes
in
sandy
loam
soil.
The
degradation
proceeds
through
the
hydrolysis
of
the
ethyl
ester
bond,
resulting
in
the
formation
of
phosphorous
acid
and
ethanol.
The
ethanol
is
further
degraded
into
carbon
dioxide.
Based
on
the
short
half­
life
of
fosetyl­
al
and
the
known
fate
of
phosphates
under
anaerobic
conditions,
EPA
determined
that
an
anaerobic
soil
metabolism
study
was
not
necessary.
An
anaerobic
aquatic
soil
metabolism
study
was
conducted.
When
anaerobic
conditions
were
established
by
flooding
soil,
the
half­
life
was
40
hours
with
silty
clay
loam,
and
14
hours
with
sandy
loam
soil.
Bayer
CropScience
expects
that
potential
fosetyl­
al
residues
in
drinking
water
are
not
a
significant
contribution
to
aggregate
exposure.
2.
Non­
dietary
exposure.
Fosetyl­
al
is
currently
registered
for
residential
use
on
turf
and
ornamental
plants.
Chronic
exposure
is
not
expected
for
residential
uses.
There
is
also
no
expectation
of
acute
risk.
No
appropriate
endpoint
attributable
to
a
single
dose
exposure
was
identified
in
oral
toxicity
studies
and
consequently,
an
acute
RfD
cannot
be
calculated.
No
endpoint
value
is
calculable
for
short­
and
intermediateterm
exposure
and
a
risk
analysis
cannot
be
performed
since
no
dermal
or
systemic
toxicity
was
seen
at
the
limit
dose
following
repeated
dermal
applications
in
the
21
 
day
toxicity
study
using
rats.
The
Agency
has
previously
concluded
that
fosetyl­
al
is
unlikely
to
pose
a
carcinogenic
hazard
to
human.
Therefore,
a
cancer
exposure
and
risk
assessment
is
not
appropriate.
Thus,
Bayer
CropScience
concludes
that
the
ornamental
and
turf
uses
do
not
add
significantly
to
the
aggregate
exposure
for
fosetyl­
al.
D.
Cumulative
Effects
Effects
associated
with
fosetyl­
al
are
unlikely
to
be
cumulative
with
any
other
compound.
The
formation
of
calculi
and
bladder
tumors
in
rats
is
the
only
significant
toxicological
effect
observed
with
fosetyl­
al.
These
effects
were
observed
in
rat
only
at
a
dose
which
not
only
exceeds
estimated
human
exposure
by
several
orders
of
magnitude
but
is
in
excess
of
the
OPP
dose
limit
for
carcinogenicity
studies.
Therefore,
an
aggregate
assessment
based
on
common
mechanisms
of
toxicity
is
not
appropriate
as
exposure
to
humans
will
be
well
below
the
levels
producing
calculi
and
bladder
tumors
in
rats.
Further,
considering
the
rapid
elimination
of
fosetyl­
al
in
the
rat
metabolism
study,
any
effects
associated
with
fosetyl­
al
are
unlikely
to
be
cumulative
with
any
other
compound.
Based
on
these
reasons,
only
the
potential
risks
of
fosetyl­
al
are
considered
in
the
exposure
assessment.

E.
Safety
Determination
1.
U.
S.
population.
Chronic
risk
estimates
associated
with
exposure
to
fosetyl­
al
in
food
and
water
are
expected
to
be
well
below
the
Agency's
level
of
concern.
The
Tier
I
chronic
exposure
analysis
performed
by
the
Agency
for
all
currently
registered
food
uses
shows
that
exposure
to
fosetyl­
al
utilizes
4.0%
of
the
cPAD
for
the
U.
S.
population,
5%
of
the
cPAD
for
infants,
and
8%
of
the
cPAD
for
children
1
 
6
years
old,
the
subpopulation
at
greatest
exposure.
This
analysis
was
conducted
assuming
100%
crop
treated
and
tolerance
level
residue
values
for
all
crops.
The
contribution
of
fosetyl­
al
residues
in
surface
water
and
ground
water
to
chronic
aggregate
exposure
is
expected
to
be
minimal.
Therefore,
Bayer
CropScience
concludes
that
even
when
considering
the
potential
incremental
risk
resulting
from
the
proposed
use
on
green
onion,
there
is
a
reasonable
certainty
that
no
harm
will
result
from
aggregate
exposure
to
fosetyl­
al
residues.
2.
Infants
and
children.
No
indication
of
increased
susceptibility
of
rat
or
rabbit
fetuses
to
in
utero
and/
or
postnatal
exposure
was
noted
in
the
developmental
and
reproductive
toxicity
studies.
The
Agency
has
previously
determined
that
no
additional
safety
factor
to
protect
infants
and
children
is
necessary
for
this
product.
Using
the
conservative
assumptions
described
in
the
exposure
section
above,
aggregate
exposure
to
fosetyl­
al
from
currently
registered
food
uses
will
utilize
up
to
8%
of
the
RfD
for
children
1
 
6
years
old,
the
subpopulation
at
greatest
exposure.
Even
when
considering
the
potential
incremental
dietary
risk
resulting
from
the
proposed
use
on
green
onion,
the
potential
for
exposure
to
residues
in
drinking
water
and
from
non­
dietary,
non­
occupational
exposure,
the
aggregate
exposure
to
fosetyl­
al
is
expected
to
be
well
below
the
level
of
concern.
Bayer
CropScience
concludes
that
there
is
a
reasonable
certainty
that
no
harm
will
result
to
infants
and
children
from
aggregate
exposure
to
fosetyl­
al
residues.

F.
International
Tolerances
There
are
no
Codex
Alimentarius
Commission
(
CODEX)
maximum
residue
limits
established
for
residues
of
fosetyl­
al
in
or
on
green
onion.
[
FR
Doc.
02
 
33107
Filed
12
 
31
 
02;
8:
45
am]

BILLING
CODE
6560
 
50
 
S
ENVIRONMENTAL
PROTECTION
AGENCY
[
FRL
 
7431
 
9]

Federal
Agency
Hazardous
Waste
Compliance
Docket
AGENCY:
Environmental
Protection
Agency.
ACTION:
Notice
of
sixteenth
update
of
the
Federal
Agency
Hazardous
Waste
Compliance
Docket,
pursuant
to
CERCLA
section
120(
c).

SUMMARY:
Section
120(
c)
of
the
Comprehensive
Environmental
Response,
Compensation,
and
Liability
Act
of
1980
(
CERCLA),
as
amended
by
the
Superfund
Amendments
and
Reauthorization
Act
of
1986
(
SARA),
requires
the
Environmental
Protection
Agency
(
EPA)
to
establish
a
Federal
Agency
Hazardous
Waste
Compliance
Docket.
The
docket
is
to
contain
certain
information
about
Federal
facilities
that
manage
hazardous
waste
or
from
which
hazardous
substances
have
been
or
may
be
released.
(
As
defined
by
CERCLA
section
101(
22),
a
release
is
any
spilling,
leaking,
pumping,
pouring,
emitting,
emptying,
discharging,
injecting,
escaping,
leaching,
dumping,
or
disposing
into
the
environment.)
CERCLA
requires
that
the
docket
be
updated
every
six
months,
as
new
facilities
are
reported
to
EPA
by
Federal
agencies.
The
following
list
identifies
the
Federal
facilities
to
be
included
in
this
sixteenth
update
of
the
docket
and
includes
facilities
not
previously
listed
on
the
docket
and
reported
to
EPA
since
the
last
update
of
the
docket,
67
FR
44200,
July
2,
2002,
which
was
current
as
of
January
31,
2002.
SARA,
as
amended
by
the
Defense
Authorization
Act
of
1997,
specifies
that,
for
each
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