Document ID: EPA-HQ-OPP-2002-0340-0001
Agency: epa
Document Type: Notice
Title: Folpet; Notice of Filing a Pesticide Petition to Establish a Tolerance for a Certain Pesticide Chemical 
in or on Food
Posted Date: 2003-01-09T05:00Z

1182
Federal
Register
/
Vol.
68,
No.
6
/
Thursday,
January
9,
2002
/
Notices
do
not
need
to
file
Initial
Briefs
in
order
to
file
Reply
Briefs.
6.
In
authorizing
the
emergency
transmission
and
delivery
of
electric
capacity
and
energy,
the
Emergency
Order
limited
the
service
provided
by
CSC
for
LIPA
as
follows:

[
T]
his
order
*
*
*
shall
be
limited
to
requiring
the
transmission
and
delivery
of
such
electric
capacity
and/
or
energy
as
is
necessary
in
the
judgment
of
the
New
York
Independent
System
Operator
to
meet
the
supply
and
essential
reserve
margin
needs
of
LIPA
*
*
*
and
*
*
*
prior
to
exercising
its
judgment
as
required
by
this
order,
the
New
York
Independent
System
Operator
must
consult
with
ISO
 
New
England,
Inc.
to
ensure
that
the
scheduling
of
such
electric
capacity
and/
or
energy
will
not
violate
system
operating
criteria
*
*
*
(
Emphasis
added.)

7.
The
documents
in
the
Referral
indicate
that
``
the
day
that
DOE
issued
the
[
Emergency]
Order,
LIPA
contacted
the
NYISO
and
remained
in
almost
daily
telephone
and
e­
mail
communication
with
NYISO
to
determine
what
those
emergency
operating
and
scheduling
protocols
would
be.''
The
documents
further
indicate
that
the
``
Implementation
Protocol
for
Emergency
Operation
of
the
Cross
Sound
Cable''
(
Protocol
for
Emergency
CSC
Operation)
was
not
made
available
to
LIPA
until
NYISO
sent
a
facsimile
transmission
to
LIPA
on
September
23,
2002,
one
week
before
the
Emergency
Order
expired.
8.
To
help
the
Commission
understand
the
reasons
for
the
delay
in
establishing
the
Protocol
for
Emergency
CSC
Operation
as
ordered
by
the
Secretary,
and
to
help
the
Commission
ensure
that
such
a
delay
does
not
occur
again,
NYISO
and
ISO
 
New
England
are
hereby
directed
to
answer
the
following
questions
on
or
before
January
31,
2003:
A.
Explain
in
detail
why
NYISO
and
ISO­
New
England
did
not
establish
the
Protocol
for
Emergency
CSC
Operation
within
a
week
or
less
of
the
issuance
of
the
Secretary's
Emergency
Order.
B.
Explain
in
detail
the
processes
followed
and
the
reasons
why
it
took
38
days
to
issue
the
Protocol
for
Emergency
CSC
Operation.
C.
Explain
whether
the
same
processes
would
be
used
if
the
Secretary
issued
another
emergency
order.
If
not,
what
changes
would
be
made?
D.
The
fourth
paragraph
of
the
Protocol
for
Emergency
CSC
Operation
states:
All
costs
associated
with
energy
provided
pursuant
to
the
[
Emergency]
Order
and
this
Protocol
shall
be
governed
by
the
Emergency
Transactions
Agreement
entered
into
between
the
NYISO
and
the
New
England
Power
Pool
on
August
14,
2000.
(
1)
Identify
and
support
all
costs
associated
with
providing
energy
under
the
Emergency
Order
including
expenses
associated
with
establishing
the
Protocol
for
Emergency
CSC
Operation.
(
2)
Provide
a
copy
of
the
August
14
Emergency
Transactions
Agreement
and
the
protocols
used
to
support
such
agreement.
E.
Is
there
a
scheduling
and
operating
protocol
which
will
be
used
if
another
emergency
order
is
issued
or
when
the
CSC
is
fully
operational?
9.
Any
comments
parties
have
with
respect
to
the
answers
provided
by
the
ISOs
may
be
included
in
separate
sections
of
the
Initial
or
Reply
Briefs.

The
Commission
Orders
(
A)
Procedures
for
Commission
action
on
the
Referral
are
hereby
established
as
discussed
in
the
body
of
this
order.
(
B)
The
NYISO
and
ISO
 
NE
are
hereby
directed
to
submit
responses,
as
discussed
in
the
body
of
this
order.

By
the
Commission.

Magalie
R.
Salas,
Secretary.
[
FR
Doc.
03
 
365
Filed
1
 
8
 
03;
8:
45
am]

BILLING
CODE
6717
 
01
 
P
ENVIRONMENTAL
PROTECTION
AGENCY
[
FRL
 
7437
 
2]

EPA
Public
Meeting
 
Closing
the
Gap:
Innovative
Responses
for
Sustainable
Water
Infrastructure;
Notice
of
Public
Meeting
AGENCY:
Environmental
Protection
Agency
(
EPA).
ACTION:
Notice.

SUMMARY:
The
Environmental
Protection
Agency
is
hosting
a
one­
day
public
forum
to
discuss
water
and
wastewater
infrastructure
in
the
United
States.
EPA's
goal
is
to
bring
together
stakeholders,
including
those
from
business,
government,
and
academia,
to
exchange
information
and
views
on
management
and
sustainable
financing
of
the
nation's
water
and
wastewater
infrastructure.
The
meeting
will
be
in
Washington,
DC,
on
January
31,
2003,
starting
at
9
a.
m.
This
meeting
is
open
to
the
public.
The
forum
will
be
composed
primarily
of
two
moderated
expert
panels
who
will
offer
their
insights.
At
the
forum,
the
audience
will
have
an
opportunity
to
provide
questions
to
be
discussed
by
the
experts.
DATES:
The
meeting
will
begin
at
9
a.
m.
on
January
31,
2003.
ADDRESSES:
The
meeting
will
be
held
in
the
ballroom
at
the
Marriott
at
Metro
Center
at
775
12th
Street,
NW.,
Washington,
DC
20005.
FOR
FURTHER
INFORMATION
CONTACT:
For
more
information
on
the
location
and
agenda
of
this
meeting,
and
general
background
information
including
related
documents
and
reports
on
water
and
wastewater
infrastructure
needs,
please
see
the
Office
of
Water
Web
Page
at
http://
www.
epa.
gov/
ow/
or
contact
the
Safe
Drinking
Water
Hotline,
phone:
(
800)
426
 
4791
or
(
703)
285
 
1093.
To
assist
in
making
arrangements
for
the
number
of
attendees,
please
send
an
email
to
closingthegap@
cadmusgroup.
com
with
the
name,
title,
and
organization
of
each
person
attending.
Seating
is
limited
to
300
people.
If
you
need
special
accommodations
at
this
meeting,
including
signing,
you
should
contact
Shawna
Bergman
at
(
202)
564
 
3641
by
January
24,
2003,
so
that
we
can
make
appropriate
arrangements.

Dated:
January
3,
2003.
G.
Tracy
Mehan,
III,
Assistant
Administrator
for
Water.
[
FR
Doc.
03
 
392
Filed
1
 
8
 
03;
8:
45
am]

BILLING
CODE
6560
 
50
 
P
ENVIRONMENTAL
PROTECTION
AGENCY
[
OPP
 
2002
 
0340;
FRL
 
7287
 
7]

Folpet;
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
 
0340,
must
be
received
on
or
before
February
10,
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:
Cynthia
Giles­
Parker,
Registration
Division
(
7505C),
Office
of
Pesticide
Programs,
Environmental
Protection
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08,
2003
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09JAN1.
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09JAN1
1183
Federal
Register
/
Vol.
68,
No.
6
/
Thursday,
January
9,
2002
/
Notices
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460
 
0001;
telephone
number:
(
703)
305
 
7740;
e­
mail
address:
giles­
parker.
cynthia@
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
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
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
identification
(
ID)
number
OPP
 
2002
 
0340.
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
 
0340.
The
system
is
an
``
anonymous
access''
system,
which
means
EPA
will
not
know
your
identity,
e­
mail
address,
or
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Federal
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/
Vol.
68,
No.
6
/
Thursday,
January
9,
2002
/
Notices
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
 
0340.
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
 
0340.
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
 
0340.
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.
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:
January
2,
2003.
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
FFDCA
section
408(
d)(
3).
The
summary
of
the
petition
was
prepared
by
the
petitioner
and
represents
the
view
of
the
petitioner.
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.

Makhteshim­
Agan
of
North
America
Inc.

2E6512
EPA
has
received
a
pesticide
petition
(
2E6512)
from
Makhteshim­
Agan
of
North
America
Inc.
(
MANA),
551
Fifth
Ave.,
Suite
1100
New
York,
NY
10176
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
folpet
N­
[(
trichloromethyl)]
thiophthalimide
in
or
on
the
raw
agricultural
commodity
hop
at
120
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
supports
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
residue
of
folpet
in
plants
is
adequately
understood
based
on
acceptable
avocado,
grape
and
wheat
metabolism
studies.
The
metabolism
of
folpet
in
livestock
is
adequately
understood.
Based
on
the
results
observed
in
the
metabolism
studies,
secondary
residues
such
as
phthalimide
and
phthalic
acid
are
not
expected
to
be
of
toxicological
concern.
The
residue
of
concern
is
folpet
per
se.
2.
Analytical
method.
An
adequate
gas
chromatography/
electron
capture
detector
(
GC/
ECD)
analytical
method
is
available
for
enforcing
tolerances
of
folpet
in
or
on
plant
commodities.
The
method
of
detection
had
a
limit
of
detection
(
LOD)
of
0.01
mg/
kg
(
ppm)
and
a
limit
of
quantitation
(
LOQ)
of
0.02
milligrams/
kilogram
(
mg/
kg)
(
ppm)
in
dried
hops.

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Notices
3.
Magnitude
of
residues.
Five
residue
trials
have
been
conducted
in
Bavaria,
Germany
during
1996
and
1997.
The
hops
were
treated
up
to
8
times
per
season
at
a
rate
of
up
to
4.3
kg
active
ingredients/
hectare
(
a.
i./
ha)
(
up
to
23
kg
a.
i./
ha
per
season),
considering
a
14
day
PHI.
After
kiln
drying,
the
measured
residues
in
hops
ranged
from
25
to
65
ppm.
Folpet
was
not
detectable
in
any
of
the
processed
hop
commodities
(
LOD
for
spent
hops
=
0.01
ppm;
beer
=
0.003
ppm).
The
generated
data
support
the
requested
tolerance.

B.
Toxicological
Profile
1.
Acute
toxicity.
In
studies
using
laboratory
animals,
in
general
folpet
has
been
shown
to
be
of
low
acute
toxicity:
The
acute
oral
LD50
and
the
acute
dermal
LD50
in
rats
were
greater
than
5,000
mg/
kg.
The
acute
rat
inhalation
LC50
(
4­
hour)
was
0.48
mg/
l.
Folpet
was
irritating
to
the
eyes
of
rabbits.
It
was
not
irritating
to
rabbit
skin
in
a
standard
dermal
irritation
study
but
was
a
dermal
sensitizer
in
a
guinea
pig
maximization
study.
Based
on
these
results,
folpet
is
expected
to
be
classified
as
TOXICITY
CATEGORY
IV
for
acute
oral
and
dermal
toxicity,
and
skin
irritation,
and
as
TOXICITY
CATEGORY
II
for
acute
inhalation
toxicity,
and
eye
irritation.
2.
Genotoxicty.
Folpet
was
tested
for
genotoxic
effects
in
several
standard
tests.
Folpet
is
neither
mutagenic
nor
genotoxic
in
mammals.
In
some
of
the
in
vitro
studies
mutagenic
events
were
observed,
such
as
gene
mutations/
DNA
damage
in
bacteria
and
mammalian
cells,
chromosomal
aberrations
in
mammalian
cells
and
mitotic
recombination
in
yeast.
However,
folpet
does
not
present
a
genotoxic
risk
based
on
the
fact
that
folpet
degrades
with
a
half­
life
of
0.97
seconds
in
vivo.
This
fast
detoxification
effectively
eliminates
systemic
exposure
to
folpet
or
thiophosgene.
3.
Reproductive
and
developmental
toxicity.
In
an
oral
developmental
study
with
New
Zealand
rabbits,
the
maternal
and
developmental
no
observed
adverse
effect
level
(
NOAEL)
was
10
mg/
kg/
day
based
on
decreased
food
consumption,
increased
number
of
fetuses
and
litters
with
hydrocephalus
and
associated
skull
malformations
at
the
lowest
observed
adverse
effect
level
(
LOAEL)
of
20
mg/
kg/
day.
In
the
rat
developmental
study
the
developmental
no
observed
effect
level
(
NOEL)
was
60
mg/
kg
and
the
lowest
observed
effect
level
(
LOEL)
was
360
mg/
kg.
A
two­
generation
reproductive
study
in
rats
produced
a
parental
NOEL
of
34.5
mg/
kg/
day.
There
was
a
marginal
decrease
in
the
body
weight
of
the
F1
offspring
at
birth
and
during
lactation
but
no
other
changes
in
physical,
functional,
or
behavioral
endpoints
were
observed.
The
NOEL
in
the
F2
of
40
mg/
kg/
day
was
based
on
decreased
body
weight
gain
and
decreased
fertility
of
the
males.
The
LOEL
in
this
study
was
180
mg/
kg.
For
both
developmental
and
reproductive
bioassays,
the
effects
elicited
by
folpet
are
considered
secondary
to
its
primary
effect:
irritancy
of
the
gastrointestinal
tract.
Folpet
is
absent
in
the
systemic
circulation
and
its
initial
ring
degradate,
phthalimide,
has
been
shown
not
to
be
a
developmental
toxin.
4.
Subchronic
toxicity.
In
a
90­
day
feeding
study
in
rats,
the
NOEL
was
established
at
3,000
ppm
and
the
LOEL
was
10,000
ppm.
Noted
effects
were
decreased
brain
weight
and
decreased
total
blood
protein
including
albumin.
In
a
subchronic
dermal
toxicity
study,
folpet
was
applied
to
rats
at
dose
levels
of
0,
1,
10,
and
30
mg/
kg
body
weight
for
6
hours
per
day,
5
days
a
week,
for
a
total
of
21
days
over
a
period
of
30
days.
All
folpet
treated
rats
developed
pronounced
dermal
irritation
in
a
doserelated
manner.
Systemic
toxicity
based
on
decreased
body
weight
gain
was
observed
at
10
and
30
mg/
kg
dose
levels,
but
without
clearly
separating
this
effect
to
the
severe
skin
damage.
5.
Chronic
toxicity.
A
2­
year
feeding
chronic
toxicity/
carcinogenicity
study
in
rats
was
conducted
with
folpet
at
dietary
concentrations
of
0,
200,
800,
or
3,200
ppm.
For
chronic
toxicity,
the
NOAEL
was
200
ppm
(
9
mg/
kg/
day)
and
the
LOAEL
was
800
ppm
(
35
mg/
kg)
based
on
hyperkeratosis/
acanthosis
and
ulceration/
erosion
of
the
non­
glandular
stomach
in
males
and
females.
No
evidence
of
carcinogenicity
was
observed
in
this
study.
A
2­
year
feeding
chronic
toxicity/
carcinogenicity
study
in
CD­
1
mice
showed
a
statistically
significant,
doserelated
increase
in
the
incidence
of
duodenal
adenocarcinomas
with
an
increase
of
about
50%
at
the
highest
dose
tested
(
1,429
mg/
kg/
day).
A
similar
response
was
seen
in
a
chronic
feeding
study
with
B6C3F1
mice
at
the
highest
dose
tested
(
HDT)
of
1,000
mg/
kg.
In
previous
assessments,
the
Agency
has
concluded
that
folpet
is
a
Group
B2
carcinogen,
based
on
the
increased
incidences
of
duodenal
adenomas
and
carcinomas
in
males
and
females
of
two
strains
of
mice.
6.
Animal
metabolism.
Results
from
the
livestock
and
rat
metabolism
studies
showed
that
orally
administered
folpet
was
rapidly
absorbed,
hydrolized
and
metabolized,
followed
by
rapid
elimination,
predominantly
via
the
urine.
The
major
fecal
degradate
was
phthalamic
acid,
while
phthalic
acid
was
a
minor
degradate.
Most
of
the
applied
dose
was
excreted
within
24
hours.
7.
Metabolite
toxicology.
There
are
no
folpet
metabolites
identified
in
plant
or
animal
commodities,
which
require
regulation.
8.
Endocrine
disruption.
The
standard
battery
of
required
toxicity
studies
has
been
completed.
These
studies
include
an
evaluation
of
the
potential
effects
on
reproduction
and
development
and
an
evaluation
of
the
pathology
of
the
endocrine
organs
following
repeated
or
long­
term
exposure.
There
is
no
evidence
which
suggests
that
folpet
is
an
endocrine
disrupter.
The
existing
studies
are
generally
considered
to
be
sufficient
to
detect
any
endocrine
effects.

C.
Aggregate
Exposure
1.
Dietary
exposure.
Potential
dietary
exposures
from
food
under
the
existing
tolerances
for
domestic
uses
(
avocados)
and
imported
commodities
(
apples,
cranberries,
cucumbers,
grapes,
lettuce,
melons,
onions,
strawberries,
and
tomatoes),
were
estimated
using
the
Dietary
Exposure
Evaluation
Model
(
DEEM)
for
acute
and
chronic
exposure
based
on
the
U.
S.
Department
of
Agriculture's
(
USDA)
1989
 
1992
individual
consumption
data.
Residue
data
were
based
on
field
trials
and
percent
crop
information
along
with
processing
factors
from
submitted
studies.
No
data
from
USDA's
Pesticide
Data
Program
(
PDP)
were
available
for
folpet.
i.
Food.
Acute
dietary
exposure
was
compared
to
the
acute
population
adjusted
dose
(
aPAD),
which
utilizes
25.3%
for
females
(
15
 
50
years)
at
the
99th
percentile,
the
only
population
group
of
concern
for
the
acute
Reference
Dose
(
aRfD
=
0.03
mg/
kg/
day,
using
the
NOAEL
of
10
mg/
kg
from
the
rabbit
study,
and
the
FQPA
safety
factor
of
3X).
The
results
of
the
chronic
(
noncancer
dietary
analysis
indicate
that
the
chronic
Population
Adjusted
Dose
(
cPAD)
was
below
1%
for
the
U.
S.
population
and
its
most
sensitive
subgroups
based
on
a
cRfD
of
0.09
mg/
kg/
day.
Concerning
the
dietary
cancer
risk,
the
Agency's
calculated
upper
bound
risk
was
9.8
x
10­
8,
based
on
a
Q*
of
0.00186
mg/
kg/
day­
1,
using
field
trial
data,
processing
factors
and
percent
crop
treated
information.
This
risk
level
is
far
less
than
EPA's
level
of
concern
of
1
x
10­
6.
Based
on
USDA's
consumption
data
not
more
than
0.0022%
of
the
U.
S.
population
diet
is
constituted
of
hops
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1186
Federal
Register
/
Vol.
68,
No.
6
/
Thursday,
January
9,
2002
/
Notices
(
Federal
Register
of
June
1,
2000,
Vol.
65,
No
106,
p.
35069
 
35090,
Table
10;
Guidance
on
Pesticide
Import
Tolerances
and
Residue
Data
for
Imported
Food).
Furthermore,
USDA's
import
statistics
show
that
not
more
than
38%
of
beer
consumed
in
the
USA
is
imported
and/
or
contains
imported
hops,
which
translates
into
a
diet
contribution
from
imported
hops
of
not
more
than
0.0007%.
For
the
purposes
of
this
risk
assessment,
it
was
also
demonstrated
in
brewing
studies
using
hops
treated
with
folpet
at
maximum
label
rates
(
range
of
residues:
25
to
65
ppm)
and
exaggerated
hopping
rates
(
0.002%
or
up
to
2
g
per
liter
wort)
that
no
folpet
residues
could
be
measured
in
the
finished
beer
(
LOD
=
0.003
ppm).
Hopping
rates
in
beer
production
are
usually
less
than
0.001%
in
brew
water
(
wort).
Even
considering
that
trace
amounts
of
folpet
would
enter
the
brewing
process,
it
will
be
rapidly
hydrolyzed
and
completely
degraded
by
the
end
of
the
beer
brewing.
In
view
of
this
information
and
assumptions,
the
resulting
dietary
risk
contribution
via
imported
hops
is
negligible,
even
if
100%
of
the
imported
hops
would
be
treated
with
folpet
at
maximum
label
rates.
ii.
Drinking
water.
The
potential
for
folpet
to
leach
into
groundwater
or
contaminate
surface
water
is
very
limited
considering
that
folpet
is
currently
only
registered
for
the
use
on
avocados
in
two
counties
in
Florida.
Based
on
the
available
information,
the
predicted
residues
in
drinking
water
do
not
indicate
an
unacceptable
contribution
to
acute
or
chronic
dietary
exposure
at
this
time.
Since
the
proposed
petition
does
not
add
any
new
uses
or
exposures
to
it,
contribution
of
any
folpet
residues
in
drinking
water
to
the
total
dietary
intake
is
negligible.
2.
Non­
dietary
exposure.
Not
applicable.

D.
Cumulative
Effects
There
is
a
common
mechanism
of
toxicity
that
folpet
shares
with
captan
with
regard
to
its
carcinogenicity
in
the
mouse.
Folpet
and
captan
share
the
common
metabolite,
thiophosgene,
which
contributes
to
the
irritancy
of
the
duodenum
in
mice
along
with
the
parent
compounds,
leading
(
at
dose
levels
above
the
established
threshold
and
for
administration
with
sufficient
time)
to
adenomas.
Thiophosgene
reacts
not
only
with
thiol
groups,
as
does
folpet
and
captan,
but
also
with
a
variety
of
other
functional
groups.
This
instability
results
in
its
rapid
loss.
The
cumulative
effect
of
captan
and
folpet
oral
exposure
is
of
theoretical
interest
only,
as
the
threshold
for
irritancy
in
the
mouse
duodenum
is
above
60
mg/
kg/
day
(
captan)
or
50
mg/
kg/
day
(
folpet).
If
the
mouse
test
system
reflected
human
susceptibility,
a
70
kg
individual
would
need
to
consume
more
than
3.5
grams
folpet
plus
captan
in
order
to
approach
the
NOEL
of
50
mg/
kg/
day.
Given
the
expected
residue
levels
of
folpet
and
those
of
captan,
this
is
not
possible.

E.
Safety
Determination
1.
U.
S.
population.
Using
the
exposure
assumptions
described
above,
MANA
concludes
that
the
total
dietary
exposure
to
folpet
is
acceptable.
According
to
import
information
statistics
from
the
USDA
and
under
the
conservative
(
worst­
case)
dietary
exposure
assumption
described
above,
not
more
than
0.0022%
of
the
U.
S.
population
diet
is
constituted
of
hops,
which
means
not
more
than
0.0007%
can
potentially
be
contributed
to
imported
hops.
Based
on
these
insignificant
dietary
contributions,
MANA
considers
the
potential
folpet
residue
contribution
negligible,
concluding
that
the
most
sensitive
population
group
of
concern
are
still
females
(
15
 
50
years)
with
an
aPAD
of
25%
and
a
cPAD
of
<
1%.
There
is
generally
no
concern
for
exposures
below
100%
of
the
PAD
since
it
represents
the
level
at
or
below
which
no
appreciable
risks
to
human
health
is
posed.
The
upper
bound
calculated
dietary
cancer
risk
was
9.8
x
10­
8,
based
on
a
Q*
of
0.00186
mg/
kg/
day­
1,
which
is
far
less
than
EPA's
level
of
concern
of
1
x
10­
6.
Thus,
there
is
reasonable
certainty
that
no
harm
will
result
to
the
U.
S.
population
in
general
or
to
any
of
its
subgroups
of
concern
from
aggregate
exposure
to
folpet
residues
in
or
on
imported
hops.
2.
Infants
and
children.
Data
from
rat
and
rabbit
development
toxicity
studies
and
rat
multigeneration
reproduction
studies
are
generally
used
to
assess
the
potential
for
increased
sensitivity
of
infants
and
children.
The
developmental
toxicity
studies
are
designed
to
evaluate
adverse
effects
on
the
developing
organism
resulting
from
pesticide
exposure
during
prenatal
development.
Reproduction
studies
provide
information
relating
to
reproductive
and
other
effects
on
adults
and
offspring
from
pre­
natal
and
postnatal
exposure
to
the
pesticide.
FFDCA
Section
408
provides
that
the
Agency
may
apply
an
additional
safety
factor
for
infants
and
children
to
account
for
pre­
and
post­
natal
toxicity
or
incompleteness
of
the
database.
However,
the
toxicology
database
for
folpet
regarding
potential
pre­
and
postnatal
effects
in
offspring
is
complete
according
to
existing
Agency
data
requirements
and
does
not
indicate
any
particular
developmental
or
reproductive
concerns.
EPA
assigned
an
FQPA
safety
factor
of
3x
in
the
1999
Reregistration
Eligibility
Decision
(
RED).
This
was
based
on
the
apparent
hydrocephaly
seen
in
New
Zealand
rabbits.
Subsequently,
additional
data
were
provided
to
the
Agency
that
showed
folpet
does
not
induce
hydrocephaly.
The
Agency
agreed
with
the
assessment
contained
in
the
submitted
document
and
rescinded
its
request
for
a
new
rabbit
study.
The
Agency
has
not,
as
of
yet,
removed
the
FQPA
3x
safety
factor.
A
FQPA
safety
factor
of
1x
would
be
also
consistent
with
that
of
captan.
The
appropriate
acute
Reference
Dose
(
aRfD)
for
folpet,
calculated
with
a
FQPA
safety
factor
of
1x,
would
be
0.01
mg/
kg/
day.
This
aRfD
should
be
used
in
future
assessments
concerning
the
potential
risks
to
infants
and
children.
However,
for
the
purpose
of
this
assessment,
MANA
used
the
existing
aRfD
of
0.03
mg/
kg/
day,
as
it
was
done
in
the
1999
RED.
MANA
concludes
that
there
is
a
reasonable
certainty
that
no
harm
will
result
to
infants
and
children
from
the
anticipated
dietary
exposure
to
residues
of
folpet
and
considering
that
the
proposed
import
tolerance
does
not
affect
foods
and
beverages
legally
consumed
by
children
and
infants.

F.
International
Tolerances
Germany
has
established
an
MRL
(
maximum
residue
limit)
of
120
ppm
for
residues
of
folpet
in
dried
hops.
No
CODEX
MRL
for
hops
exists.
[
FR
Doc.
03
 
389
Filed
1
 
8
 
03;
8:
45
am]

BILLING
CODE
6560
 
50
 
S
ENVIRONMENTAL
PROTECTION
AGENCY
[
FRL
 
7437
 
1]

Proposed
CERCLA
Section
122(
h)(
1)
Administrative
Agreement
for
Recovery
of
Response
Costs
for
the
City
Chemical
Corporation
Site,
Hudson
County,
Jersey
City,
NJ
AGENCY:
Environmental
Protection
Agency
(
EPA).
ACTION:
Notice;
request
for
public
comment.

SUMMARY:
In
accordance
with
section
122(
i)
of
the
Comprehensive
Environmental
Response,
Compensation,
and
Liability
Act
of
1980,
as
amended
(``
CERCLA''),
42
U.
S.
C.
9622(
i),
notice
is
hereby
given
by
the
U.
S.
Environmental
Protection
Agency
(``
EPA''),
Region
II,
of
a
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