Document ID: EPA-HQ-OPP-2003-0256-0001
Agency: epa
Document Type: Notice
Title: Indian Meal Moth Granulosis Virus; Notice of Filing a Pesticide Petition to Establish a Tolerance for a Certain Pesticide Chemical in or on Food
Posted Date: 2003-07-30T04:00Z

44780
Federal
Register
/
Vol.
68,
No.
146
/
Wednesday,
July
30,
2003
/
Notices
commodity
is
100%
of
a
daily
diet.
Thus,
in
making
a
safety
determination
for
these
tolerance
exemptions,
Valent
BioSciences
Corporation
took
into
account
this
very
conservative
exposure
assessment.
The
last
application
precedes
harvest
by
approximately
2.5
months
in
apples,
therefore
the
potential
for
dietary
exposure
is
considered
negligible
by
Valent
BioSciences
Corporation.
Application
precedes
harvest
by
approximately
2
months
in
pistachios.
Also
pistachios
have
their
hulls,
which
cover
the
shell,
removed
at
harvest,
therefore
the
potential
for
dietary
exposure
is
considered
negligible
by
Valent
BioSciences
Corporation.
Residues
are
below
the
LOQ
(
LOQ
=
0.05
ppm)
in
pistachio.
ii.
Drinking
water.
The
proposed
uses
on
apples
and
pistachios
are
not
expected
to
add
potential
exposure
to
drinking
water.
Soil
leaching
studies
have
suggested
that
6­
BA
is
relatively
immobile,
absorbing
to
sediment.
Residues
reaching
surface
waters
from
field
runoff
should
quickly
absorb
to
sediment
particles
and
be
partitioned
from
the
water
column.
6­
Benzyladenine
also
has
low
solubility
in
water,
0.061
mg/
mL,
and
detections
in
ground
water
are
not
expected.
Valent
BioSciences
Corporation
concludes
that
together
these
data
indicate
that
residues
are
not
expected
in
drinking
water.
2.
Non­
dietary
exposure.
The
proposed
uses
involve
application
of
6­
BA
to
crops
grown
in
an
agricultural
environment.
The
only
non­
dietary
exposure
expected
is
that
to
applicators.
However,
the
protective
measures
prescribed
by
the
product's
label
are
expected
to
be
adequate
to
minimize
exposure
and
protect
applicators
of
the
chemical.

E.
Cumulative
Exposure
No
cumulative
adverse
effects
are
expected
from
long­
term
exposure
to
this
chemical.
There
is
no
reliable
information
to
indicate
that
toxic
effects
produced
by
6­
BA
would
be
cumulative
with
those
of
any
other
pesticide
chemical.

F.
Safety
Determination
1.
U.
S.
population.
Chronic
dietary
exposure
estimates
were
conducted
for
the
overall
U.
S.
population
and
25
population
subgroups,
including
infants
and
children.
These
estimated
daily
intakes
were
compared
against
a
chronic
population
adjusted
dose
(
PAD)
based
on
a
NOAEL
of
50
mg/
kg
bwt/
day
from
a
developmental
study
in
rats.
To
account
for
intraspecies
and
interspecies
variation
and
the
use
of
an
acute
toxicological
endpoint
for
a
chronic
assessment,
an
uncertainty
factor
(
UF)
of
1,000
was
applied
to
the
acute
NOAEL.
This
resulted
in
a
chronic
PAD
of
0.05
mg/
kg
bwt/
day.
Daily
exposure
for
the
overall
U.
S.
population
was
estimated
to
be
0.000014
mg/
kg
bwt/
day,
representing
less
than
0.1%
of
the
estimated
chronic
PAD.
2.
Infants
and
children.
Estimated
daily
exposures,
assuming
that
100%
of
the
apple
and
pistachio
commodities
in
the
United
States
are
treated
with
6­
BA,
for
the
most
highly
exposed
population
subgroup,
non­
nursing
infants,
was
estimated
to
be
0.000085
mg/
kg
bwt/
day,
or
0.2%
of
the
estimated
chronic
PAD.

G.
Effects
on
the
Immune
and
Endocrine
Systems
6­
Benzyladenine
is
a
naturally
occurring
cytokinin
which
has
plant
growth
regulator
properties.
There
is
no
indication
that
this
plant
growth
regulator
belongs
to
a
class
of
chemicals
known
or
suspected
of
having
adverse
effects
on
the
immune
and
endocrine
systems.
It
can
be
concluded
that
based
upon
the
existing
toxicology
there
would
be
no
adverse
effects
on
the
immune
or
endocrine
systems
from
the
use
of
6­
BA.
Last,
there
is
no
evidence
that
6­
BA
bioaccumulates
in
the
environment.

H.
Existing
Tolerances
The
plant
growth
regulator
6­
BA
is
exempt
from
the
requirement
of
a
tolerance
when
used
as
a
fruit­
thinning
agent
at
an
application
rate
not
to
exceed
30
grams
of
active
ingredient
per
acre
in
or
on
apples.
6­
Benzyladenine
is
temporarily
exempt
from
the
requirement
of
a
tolerance
in
or
on
apples
at
 
182
grams
of
active
ingredient
per
acre
per
season,
and
in
or
on
pistachio
at
 
60
grams
of
active
ingredient
per
acre
per
season
when
used
in
accordance
with
the
Experimental
Use
Permit
73049
 
EUP
 
2.
The
exemption
from
a
tolerance
will
expire
on
January
31,
2005.

I.
International
Tolerances
There
are
no
codex,
Canadian,
or
Mexican
maximum
residue
limits
for
use
of
6­
BA
on
apple
or
pistachio.
[
FR
Doc.
03
 
19280
Filed
7
 
29
 
03;
8:
45
am]

BILLING
CODE
6560
 
50
 
S
ENVIRONMENTAL
PROTECTION
AGENCY
[
OPP
 
2003
 
0256;
FRL
 
7319
 
7]

Indian
Meal
Moth
Granulosis
Virus;
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
 
2003
 
0256,
must
be
received
on
or
before
August
29,
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:
Leonard
Cole,
Biopesticides
and
Pollution
Prevention
Division
(
7511C),
Office
of
Pesticide
Programs,
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460
 
0001;
telephone
number:
(
703)
305
 
5412;
e­
mail
address:
cole.
leonard@
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.

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/
Vol.
68,
No.
146
/
Wednesday,
July
30,
2003
/
Notices
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
 
2003
 
0256.
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.
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
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
 
2003
 
0256.
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
 
2003
 
0256.
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
 
2003
 
0256.

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44782
Federal
Register
/
Vol.
68,
No.
146
/
Wednesday,
July
30,
2003
/
Notices
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
 
2003
 
0256.
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:
July
21,
2003.
Janet
L.
Andersen,
Director,
Biopesticides
and
Pollution
Prevention
Division,
Office
of
Pesticide
Programs.

Summary
of
Petition
The
petitioner
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.

AgriVir,
LLC
PP
3F6736
EPA
received
a
pesticide
petition
(
PP
3F6736)
from
AgriVir,
LLC,
1901
L
St.,
NW.,
Suite
250,
Washington,
DC
20036,
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
180.1218
to
expand
the
tolerance
exemption
from
the
existing
exemption
for
use
on
dried
fruits
and
nuts
to
use
on
all
agricultural
commodities
and
relevant
processed
fractions.
EPA
has
determined
that
the
petition
contains
data
or
information
regarding
the
elements
set
forth
in
section
408(
d)(
2);
however,
EPA
has
not
completed
a
review
of
the
sufficiency
of
the
submitted
data
at
this
time.
The
summary
represents
the
views
of
AgriVir,
LLC.
EPA
is
still
in
the
process
of
evaluating
the
petition.
EPA
has
made
minor
edits
to
the
summary
for
the
purpose
of
clarity.

A.
Residue
Chemistry
Residue
chemistry,
per
se,
is
not
required
in
support
of
the
proposed
tolerance
exemption.
This
is
because
EPA
has
waived
this
requirement
for
microbial
pet
control
agents
which
do
not
trigger
Tier
II
toxicology
concerns.
Indian
Meal
Moth
Granulosis
Virus
(
IMMGV)
does
not
trigger
Tier
II
toxicology
concerns.
A
brief
summary
of
the
identity
of
the
microbial
pest
control
agent
IMMGV
follows
for
information
purposes
EPA
has
previously
registered
AgriVir's
microbial
pest
control
product
FruitGuard­
V/
NutGuard­
V
(
these
are
alternate
names
for
the
same
product),
EPA
Reg.
No.
73176
 
1.
This
is
a
biological
insecticide
intended
to
control
Indian
meal
moth,
a
serious
pest
of
various
stored
commodities.
The
Indian
meal
moth,
is
a
serious
cosmopolitan
pest
of
many
stored
agricultural
commodities
and
processed
fractions.
Infestation
can
occur
at
any
time
from
harvest
to
eventual
consumption
of
the
commodity.
Indian
meal
moth,
is
estimated
to
be
responsible,
for
example,
for
approximately
90%
of
the
damage
done
to
dried
fruits
and
nuts
in
storage.
In
facilities
where
susceptible
commodities
are
handled,
fragments
and
other
debris
from
the
commodities
gets
into
cracks,
crevices,
and
other
places
and
Indian
meal
moth,
propagates
on
this
material.
This
establishes
a
general
infestation
and
reservoir
for
the
Indian
meal
moth
in
such
facilities.
Control
of
Indian
meal
moth
by
FruitGuard­
V/
NutGuard­
V
is
by
means
of
a
naturally
occurring
microbial
pest
control
agent
(
MPCA)
which
is
contained
in
the
product.
The
MPCA
used
in
NutGuard­
V/
FruitGuard­
V
is
a
granulosis
virus
which
infects
the
larvae
of
the
Indian
meal
moth.
This
virus
is
designated
IMMGV
in
the
balance
of
this
summary.
The
MPCA
contained
in
NutGuard­
V/
FruitGuard­
V
is
a
naturally
occurring
isolate
of
the
IMMGV.
It
has
not
been
genetically
modified.
IMMGV
has
no
hosts
other
than
larvae
of
the
Indian
meal
moth
and
acts
by
making
the
Indian
meal
moth
larvae
sick,
rather
than
by
a
toxic
mechanism
(
i.
e.,
IMMGV
does
not
produce
any
specific
toxin
which
kills
the
larvae).

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30,
2003
/
Notices
Indian
meal
moth
larvae
succumb
to
granulosis
disease
due
to
serious
damage
to
one
of
their
major
organs
for
storage
of
nutrients.
The
above­
cited
products
are
equivalent
to
a
technical
grade
of
IMMGV.
They
are
prepared
without
isolation
of
IMMGV
and,
as
such,
the
MPCA
which
is
the
subject
of
the
present
petition
consists,
therefore,
of
IMMGV
occlusion
bodies
(
viral
particles)
and
Indian
meal
moth
larval
parts
mixed
into
a
production
larval
diet
containing
wheat
bran,
brewer's
yeast,
vitamins,
methyl
paraben,
and
sorbic
acid.

B.
Toxicological
Profile
The
mode
of
action
for
IMMGV
in
its
host,
the
larval
stage
of
P.
interpunctella,
is
pathogenic
in
nature.
IMMGV
produces
granulosis
disease
in
the
larvae
of
P.
interpunctella.
``
Granulosis''
disease
is
so
named
because
cells
in
infected
tissue
sections,
when
observed
under
light
microscopy,
are
full
of
minute,
refractile
bodies
termed
``
granules.''
The
initial
signs
of
granulosis
disease
occur
several
days
after
larval
ingestion
of
the
viral
occlusion
bodies
and
consist
of
sluggishness
and
loss
of
appetite.
These
initial
signs
are
followed
by
a
change
in
the
appearance
of
the
larvae.
They
are
normally
light
brown
and
semilucent
but
when
infected
become
opaque
and
white.
This
change
is
the
result
of
the
massive
accumulation
of
viral
occlusion
bodies
in
the
fat
body
of
the
infected
larva.
The
fat
body
is
the
site
of
intermediary
metabolism
in
these
larvae
and
it
is
in
the
fat
body
that
fat,
protein,
and
glycogen
are
primarily
stored.
The
pathogenicity
of
IMMGV
to
the
larva
results
from
the
mode
of
viral
release
from
cells
of
the
fat
body.
As
discussed
above,
this
occurs
by
rupture
of
the
cells
of
the
fat
body,
thereby
leading
to
degeneration
and
necrosis
of
the
fat
body
and,
ultimately,
death
of
the
infected
larva.
The
above­
cited
mode
of
action
is
distinct
from
a
toxicity
based
mode
of
action.
That
is,
unlike
some
microbial
pest
control
agents
which
produce
endo­
or
exo­
toxins
which
act
to
kill
the
target
pest,
IMMGV
produces
no
toxins
as
part
of
its
mode
of
action.
1.
Hazard
potential
to
mammals.
IMMGV
poses
no
hazard
potential
to
mammals
via
ingestion,
dermal
contact,
or
inhalation.
There
is
no
baculovirus
(
the
type
of
virus
which
IMMGV
is)
known
to
infect
or
replicate
in
any
vertebrate
host.
Among
invertebrates,
IMMGV
itself
has
no
known
host
other
than
larvae
of
P.
interpunctella
and
has
been
shown
not
to
cross­
infect
lepidopteran
or
other
insects
other
than
P.
interpunctella.
A
number
of
studies
on
the
toxicity
of
baculoviruses,
inclusive
of
granulosis
viruses,
to
animals
have
shown
that
these
agents
are
non­
toxic
by
the
oral,
dermal,
inhalation,
and
injection
routes
of
exposure
and
that
no
effects
on
overall
health,
gross
or
micro
pathology,
hematology,
clinical
chemistry,
and
antibody
stimulation
occur
in
test
animals.
These
studies
have
been
published
in
the
open
literature
and
were
submitted
as
part
of
AgriVir,
LLC's
petition.
Cell
culture
studies
(
submitted
by
AgriVir
as
part
of
its
submission)
have
shown
that
IMMGV
which
is
actively
infective
and
pathogenic
to
IMM
larva
does
not
produce
cytotoxicity
nor
does
it
replicate
in
or
produce
pathogenicity
in
the
following
mammalian
cell
lines:
WI­
38
(
ATTC
CCL
75:
human
lung
(
embryonic))
WS1
(
ATTC
CRL
1502:
human
endothelium
(
embryonic
skin))
CV­
1
(
ATTC
CCL
70:
African
green
monkey,
renal)
These
cell
culture
studies
further
support
the
already
established
fact
that
IMMGV
poses
no
hazard
to
mammals.
Due
to
the
physical
properties
of
the
final
product
and
of
the
bran
carrier,
the
technical
MPCA
does
have
a
mild
to
moderate,
reversible
eye
irritation
potential.
2.
Hazard
potential
to
the
environment.
The
only
potential
environmental
effect
of
IMMGV
is
on
the
population
of
Indian
meal
moths.
This
is
because,
as
discussed
above,
IMMGV
has
no
hosts
other
than
larvae
of
the
Indian
meal
moth
and
acts
by
a
pathogenicity
mechanism
rather
than
a
toxicity
mechanism
(
i.
e.,
IMMGV
does
produce
any
specific
toxin).
Since
IMMGV
is
a
naturally
occurring
virus
which
has
naturally
infected
Indian
meal
moth
larvae
for
at
least
decades
and
probably
longer,
its
use
on
Indian
meal
moth
larvae
which
may
infest
dried
fruits
and
nuts
and
other
stored
commodities
cannot
reasonably
be
expected
to
endanger
the
Indian
meal
moth
population
as
a
whole.
Therefore,
there
are
no
reasonably
anticipated
or
likely
environmental
effects
of
use
of
IMMGV
for
protection
of
agricultural
commodities
from
Indian
meal
moth
damage.
3.
Hazard
potential
to
non­
target
species.
There
is
no
hazard
potential
to
non­
target
species.
As
above­
noted,
there
is
no
baculovirus
known
to
infect
or
replicate
in
any
vertebrate
host.
Among
invertebrates,
IMMGV
itself
has
no
known
host
other
than
larvae
of
P.
interpunctella
and
has
been
shown
not
to
cross­
infect
lepidopteran
or
other
insects
other
than
P.
interpunctella.

C.
Aggregate
Exposure
1.
Dietary
exposure
 
i.
Food.
The
levels
of
residues
in
treated
commodities
will
be
very
low.
The
application
rates
for
IMMGV
are
from
1
to
5
ounces
of
formulated
(
i.
e.,
technical)
MPCA
per
ton
of
commodity
to
be
treated.
Therefore,
dietary
exposure
is
insignificant.
ii.
Drinking
water.
The
proposed
use
patterns
for
IMMGV
are
for
indoor
food
and
non­
food
uses.
Therefore,
there
is
no
potential
for
drinking
water
exposure
associated
with
the
approval
of
this
petition.
2.
Non­
dietary
exposure.
IMMGV
only
has
any
pest
control
utility
in
the
treatment
of
various
commodities
for
control
of
Indian
meal
moth.
Therefore,
the
only
potential
for
non­
dietary
exposure
is
to
applicators
and
to
mixer/
loaders
who
will
use
product
containing
IMMGV.
These
non­
dietary
exposures
are
not
covered
within
FQPA
and
they
are
expected
to
be
low.
Information
already
in
EPA's
data
bases
which
had
been
cited
by
AgriVir,
LLC
indicates
that
workers
involved
with
baculovirus
production
and
use
do
not
experience
adverse
effects
as
a
result
of
these
exposures.

D.
Cumulative
Effects
Due
to
its
mechanism
of
action
and
extremely
limited
host
specificity,
it
can
be
reliably
stated
that
IMMGV
does
not
share
a
common
mechanism
of
action
with
any
other
conventional,
biochemical,
or
microbial
pesticide.

E.
Endocrine
Effects
There
is
no
reliable
information
to
indicate
that
IMMGV
has
a
potential
to
produce
endocrine
effects.
The
available
studies
suggest
that
IMMGV
is
essentially
biologically
inactive
in
any
organism
other
than
its
natural
host,
the
larva
of
the
Indian
meal
moth.

F.
Safety
Determination
1.
U.
S.
population.
Since
the
available
information
reliably
supports
that
IMMGV
will
not
produce
adverse
effects
in
humans
of
any
age
as
a
result
of
exposure
by
ingestion,
dermal
contact,
or
inhalation,
AgriVir,
LLC
concludes
that
there
is
a
reasonable
certainty
that
no
harm
to
the
general
adult
population
will
result
from
dietary
exposure
to
residues
which
could
occur
as
a
result
of
approval
of
this
petition.
2.
Infants
and
children.
Since
the
available
information
reliably
supports
that
IMMGV
will
not
produce
adverse
effects
in
humans
of
any
age
as
a
result
of
exposure
by
ingestion,
dermal
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146
/
Wednesday,
July
30,
2003
/
Notices
contact,
or
inhalation,
AgriVir,
LLC
concludes
that
there
is
a
reasonable
certainty
that
no
harm
to
infants
and
children
will
result
from
dietary
exposure
to
residues
which
could
occur
as
a
result
of
approval
of
this
petition.
3.
Sensitive
individuals.
Since
the
available
information
reliably
supports
that
IMMGV
will
not
produce
adverse
effects
in
humans
of
any
age
as
a
result
of
exposure
by
ingestion,
dermal
contact,
or
inhalation,
and
indeed
that
IMMGV
appears
to
be
biologically
inactive
in
other
than
its
natural
host,
AgriVir,
LLC
concludes
that
there
is
a
reasonable
certainty
that
no
harm
to
sensitive
persons
will
result
from
dietary
exposure
to
residues
which
could
occur
as
a
result
of
approval
of
this
petition.

G.
International
Tolerances
There
are
no
Codex
maximum
residue
levels
established
for
residues
of
IMMGV.
IMMGV
containing
products
are
presently
not
registered
for
pest
control
outside
of
the
U.
S.

[
FR
Doc.
03
 
19354
Filed
7
 
29
 
03;
8:
45
am]

BILLING
CODE
6560
 
50
 
S
ENVIRONMENTAL
PROTECTION
AGENCY
[
FRL
 
7537
 
7]

Framework
for
Application
of
the
Toxicity
Equivalence
Methodology
for
Polychlorinated
Dioxins,
Furans,
and
Biphenyls
in
Ecological
Risk
Assessment
(
External
Review
Draft);
Notice
of
Availability
AGENCY:
Environmental
Protection
Agency.
ACTION:
Notice
of
availability
and
opportunity
for
public
comment.

SUMMARY:
The
U.
S.
Environmental
Protection
Agency
(
EPA)
is
announcing
a
60­
day
public
comment
period
for
the
draft
document
titled
Framework
for
Application
of
the
Toxicity
Equivalence
Methodology
for
Polychlorinated
Dioxins,
Furans,
and
Biphenyls
in
Ecological
Risk
Assessment.
The
document
is
intended
to
describe
a
methodology
for
assessing
ecological
risks
associated
with
complex
mixtures
of
dioxins,
furans,
and
dioxin­
like
PCBs
in
the
environment.
EPA
will
consider
the
public
comments
in
revising
the
document.

DATES:
Comments
must
be
received
by
September
29,
2003.
ADDRESSES:
The
draft
is
available
via
the
Internet
at
http://
cfpub.
epa.
gov/
ncea/
raf/
recordisplay.
cfm?
deid=
55669.
Comments
may
be
submitted
electronically,
by
mail,
or
in
person,
as
described
in
the
instructions
under
Supplementary
Information.
Comments
may
be
viewed
at
EPA
Dockets
at
http:/
/
www.
epa.
gov/
edocket
(
under
Docket
ID
No.
ORD
 
2003
 
0002).
FOR
FURTHER
INFORMATION
CONTACT:
Marilyn
Brower,
U.
S.
EPA,
ORD
National
Center
for
Environmental
Assessment,
Risk
Assessment
Forum
Staff
(
8601D),
1200
Pennsylvania
Ave.
NW.,
Washington,
DC
20460;
telephone:
202
 
564
 
3363;
fax:
202
 
565
 
0062;
email
brower.
marilyn@
epa.
gov.
SUPPLEMENTARY
INFORMATION:

I.
Submission
of
Comments
You
may
submit
comments
electronically,
by
mail,
or
through
hand
delivery/
courier.
To
ensure
proper
receipt
by
EPA,
identify
the
appropriate
docket
identification
number
(
ORD
 
2003
 
0002)
in
the
subject
line
on
the
first
page
of
your
comment.
Please
note
that
all
comments
received
in
response
to
this
notice
will
be
placed
in
a
public
record.
For
that
reason,
comments
should
not
contain
personal
information
(
such
as
medical
data
or
home
address),
Confidential
Business
Information,
or
information
protected
by
copyright.

A.
Electronically
to
EPA
Dockets
Your
use
of
EPA's
electronic
public
docket
(
EPA
Dockets)
to
submit
comments
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
No.
ORD
 
2003
 
0002.
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.
EPA
recommends
that
you
include
your
name
and
contact
information
in
the
body
of
your
comment
to
ensure
that
you
can
be
identified
as
the
submitter
of
the
comment
and
to
allow
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.

B.
By
Mail
Comments
may
be
sent
to:
Office
of
Environmental
Information
Docket,
Environmental
Protection
Agency,
Mailcode:
28220T,
1200
Pennsylvania
Ave.
NW,
Washington,
DC
20460,
Attention
Docket
ID
No.
ORD
 
2003
 
0002.

C.
By
Hand
Delivery
or
Courier
Deliver
your
comments
to:
Office
of
Environmental
Information
Docket,
EPA
West,
Room
B102,
1301
Constitution
Ave.
NW,
Washington,
DC,
Attention
Docket
ID
No.
ORD
 
2003
 
0002.
Such
deliveries
are
only
accepted
during
the
Docket's
normal
hours
of
operation
from
8:
30
a.
m.
to
4:
30
p.
m.,
Monday
through
Friday,
excluding
legal
holidays.
The
telephone
number
for
the
docket
is
202
 
566
 
1752.

II.
Background
Polychlorinated
dioxins
(
PCDDs),
furans
(
PCDFs),
and
biphenyls
(
PCBs)
commonly
occur
as
complex
mixtures
in
the
environment.
For
more
than
a
decade,
EPA
and
other
organizations
have
estimated
the
combined
risks
that
such
mixtures
pose
to
human
health
using
a
method
known
as
the
toxicity
equivalence
methodology.
The
methodology
is
based
on
findings
that
certain
PCDDs,
PCDFs,
and
PCBs
share
a
common
mechanism
of
action
for
their
effects
but
differ
in
potency.
The
methodology
uses
potency
factors
(
such
as
Toxicity
Equivalence
Factors,
or
TEFs)
assigned
to
each
chemical
in
the
mixture
as
a
way
of
integrating
the
risks
from
the
entire
mixture.
Application
in
ecological
risk
assessments
has
proceeded
more
slowly
than
in
human
health
risk
assessment,
in
part
because
of
the
variety
of
species
from
different
taxonomic
classes
(
e.
g.,
fish,
birds,
and
mammals)
to
be
considered.
As
both
data
and
experience
with
the
methodology
have
accumulated,
however,
experts
have
concluded
that
the
toxicity
equivalence
methodology
can
strengthen
assessments
of
ecological
risks.
At
a
World
Health
Organization
consultation
in
1997,
international
consensus
TEFs
for
PCDDs,
PCDFs,
and
PCBs
were
reviewed
and
the
toxicity
equivalence
methodology
expanded
to
include
class­
specific
TEFs
for
mammals,
birds
and
fish.
In
1998,
EPA
and
the
U.
S.
Department
of
Interior
sponsored
a
workshop
that
recommended
the
development
of
further
guidance
on
application
of
the
toxicity
equivalence
methodology.
This
draft
framework
has
been
developed
in
direct
response
to
that
workshop
recommendation
by
a
technical
panel
under
EPA's
Risk
Assessment
Forum.
Organized
in
accordance
with
EPA's
Guidelines
for
Ecological
Risk
Assessment
(
63
FR
26846),
this
framework
is
intended
to
assist
EPA
scientists
in
using
the
methodology,
as
well
as
to
inform
EPA
decision
makers,
other
agencies,
and
the
public
about
this
methodology.
It
provides
ecological
risk
assessors
with
an
understanding
of
the
uncertainties
associated
with
the
application
of
the
methodology
in
general
and
with
situation­
specific
decisions
made
in
applying
the
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