Document ID: EPA-HQ-OPP-2003-0113-0001
Agency: epa
Document Type: Rule
Title: Bacillus Pumilus Strain QST2808; Temporary Exemption From the Requirement of a Tolerance
Posted Date: 2003-06-18T04:00Z

36476
Federal
Register
/
Vol.
68,
No.
117
/
Wednesday,
June
18,
2003
/
Rules
and
Regulations
Commodity
Parts
per
million
*
*
*
*
*
Corn,
field,
forage
....................................................................................................
6.0
*
*
*
*
*
Grain,
aspirated
fractions
........................................................................................
100.0
*
*
*
*
*

*
*
*
*
*

[
FR
Doc.
03
 
15128
Filed
6
 
17
 
03;
8:
45
am]

BILLING
CODE
6560
 
50
 
S
ENVIRONMENTAL
PROTECTION
AGENCY
40
CFR
Part
180
[
OPP
 
2003
 
0113;
FRL
 
7301
 
1]

Bacillus
Pumilus
Strain
QST2808;
Temporary
Exemption
From
the
Requirement
of
a
Tolerance
AGENCY:
Environmental
Protection
Agency
(
EPA).
ACTION:
Final
rule.

SUMMARY:
This
regulation
establishes
a
temporary
exemption
from
the
requirement
of
a
tolerance
for
residues
of
the
Bacillus
pumilus
strain
QST2808
in
or
on
all
agricultural
commodities
when
applied/
used
in
accordance
with
label
directions.
AgraQuest,
Inc.
submitted
a
petition
to
EPA
under
the
Federal
Food,
Drug,
and
Cosmetic
Act
(
FFDCA),
as
amended
by
the
Food
Quality
Protection
Act
of
1996
(
FQPA),
requesting
the
temporary
tolerance
exemption.
This
regulation
eliminates
the
need
to
establish
a
maximum
permissible
level
for
residues
of
Bacillus
pumilus
strain
QST2808.
The
temporary
tolerance
exemption
will
expire
on
June
30,
2006.
DATES:
This
regulation
is
effective
June
18,
2003.
Objections
and
requests
for
hearings,
identified
by
docket
ID
number
OPP
 
2003
 
0113,
must
be
received
by
EPA
on
or
before
August
18,
2003.
ADDRESSES:
Written
objections
and
hearing
requests
may
be
submitted
by
mail
or
through
hand
delivery/
courier.
Follow
the
detailed
instructions
as
provided
in
Unit
VIII.
of
the
SUPPLEMENTARY
INFORMATION.

FOR
FURTHER
INFORMATION
CONTACT:
Susanne
Cerrelli,
Biopesticides
and
Pollution
Prevention
Division
(
7511C),
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460
 
0001;
telephone
number:
(
703)
308
 
8077
;
e­
mail
address:
cerrelli.
susanne@
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/
Agriculture
(
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.
To
determine
whether
you
or
your
business
may
be
affected
by
this
action,
you
should
carefully
examine
the
applicability
provisions.
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
 
2003
 
0113.
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/.
A
frequently
updated
electronic
version
of
40
CFR
part
180
is
available
at
http://
www.
access.
gpo.
gov/
nara/
cfr/
cfrhtml_
00/
Title
_
40/
40cfr180
_
00.
html,
a
beta
site
currently
under
development.
To
access
the
OPPTS
Harmonized
Guidelines
referenced
in
this
document,
go
directly
to
the
guidelines
at
http://
www.
epa.
gov/
opptsfrs/
home/
guidelin.
htm.
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.

II.
Background
and
Statutory
Findings
In
the
Federal
Register
of
May
3,
2001
(
66
FR
22225)
(
FRL
 
6773
 
9),
EPA
issued
a
notice
pursuant
to
section
408
of
the
FFDCA,
21
U.
S.
C.
346a,
as
amended
by
FQPA
(
Public
Law
104
 
170),
announcing
the
filing
of
a
pesticide
tolerance
petition
(
PP
1G6240),
submitted
by
AgraQuest,
Inc.,
1530
Drew
Avenue,
Davis,
CA
95616.
This
notice
included
a
summary
of
the
petition
prepared
by
the
petitioner
AgraQuest,
Inc.
There
were
no
comments
received
in
response
to
the
notice
of
filing.
The
petition
requested
that
40
CFR
part
180
be
amended
by
establishing
a
temporary
exemption
from
the
requirement
of
a
tolerance
for
residues
of
Bacillus
pumilus
strain
QST2808.
Section
408(
c)(
2)(
A)(
i)
of
the
FFDCA
allows
EPA
to
establish
an
exemption
from
the
requirement
for
a
tolerance
(
the
legal
limit
for
a
pesticide
chemical
residue
in
or
on
a
food)
only
if
EPA
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68,
No.
117
/
Wednesday,
June
18,
2003
/
Rules
and
Regulations
determines
that
the
exemption
is
``
safe.''
Section
408(
c)(
2)(
A)(
ii)
of
the
FFDCA
defines
``
safe''
to
mean
that
``
there
is
a
reasonable
certainty
that
no
harm
will
result
from
aggregate
exposure
to
the
pesticide
chemical
residue,
including
all
anticipated
dietary
exposures
and
all
other
exposures
for
which
there
is
reliable
information.''
This
includes
exposure
through
drinking
water
and
in
residential
settings,
but
does
not
include
occupational
exposure.
Section
408(
b)(
2)(
C)
of
the
FFDCA
requires
EPA
to
give
special
consideration
to
exposure
of
infants
and
children
to
the
pesticide
chemical
residue
in
establishing
a
tolerance
and
to
``
ensure
that
there
is
a
reasonable
certainty
that
no
harm
will
result
to
infants
and
children
from
aggregate
exposure
to
the
pesticide
chemical
residue.
.
.
.''
Additionally,
section
408(
b)(
2)(
D)
of
the
FFDCA
requires
that
the
Agency
consider
``
available
information
concerning
the
cumulative
effects
of
a
particular
pesticide's
residues''
and
``
other
substances
that
have
a
common
mechanism
of
toxicity.''
EPA
performs
a
number
of
analyses
to
determine
the
risks
from
aggregate
exposure
to
pesticide
residues.
First,
EPA
determines
the
toxicity
of
pesticides.
Second,
EPA
examines
exposure
to
the
pesticide
through
food,
drinking
water,
and
through
other
exposures
that
occur
as
a
result
of
pesticide
use
in
residential
settings.

III.
Toxicological
Profile
Consistent
with
section
408(
b)(
2)(
D)
of
the
FFDCA,
EPA
has
reviewed
the
available
scientific
data
and
other
relevant
information
in
support
of
this
action
and
considered
its
validity,
completeness
and
reliability
and
the
relationship
of
this
information
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.
Bacillus
pumilus
is
a
ubiquitous
and
naturally
occurring
bacteria
found
in
soil.
The
results
of
the
acute
toxicology
and
pathogenicity
studies
required
of
the
petitioner
under
section
408(
d)(
2)(
A)
of
the
FFDCA
in
support
of
its
petition
for
a
temporary
exemption
from
the
requirement
of
a
tolerance
for
Bacillus
pumilus
strain
QST2808
indicate
negligible
to
no
mammalian
toxicity.
In
addition,
no
pathogenicity
was
observed
in
any
of
the
tests
conducted
with
the
Bacillus
pumilus
strain
QST2808
Technical
product.
The
toxicology
and
pathogenicity
data
generated
by
AgraQuest,
Inc
in
support
of
this
temporary
exemption
from
the
requirement
of
a
tolerance
are
summarized
below.
1.
Acute
oral
toxicity
and
pathogenicity
rats
(
OPPTS
Harmonized
Guideline
885.3050;
Master
Record
Identification
Number
(
MRID)
451366
 
04).
Fifteen
male
and
fifteen
female
rats
each
were
administered
4.1
x
109
cfu
of
Bacillus
pumilus
strain
QST2808
Technical
and
observed
for
14
days.
Based
on
the
data,
Bacillus
pumilus
strain
QST2808
does
not
appear
to
be
toxic,
infective,
and/
or
pathogenic
in
rats,
when
dosed
at
4.1
x
109
cfu/
animal.
Classification:
Acceptable;
Toxicity
Category
IV.
(
C.
Etsitty's
Memorandum
to
John
L.
Kough,
dated
1/
7/
02
(
hereinafter
referred
to
as
``
BPPD
Review
­
1/
7/
02'')).
2.
Acute
dermal
toxicity
(
OPPTS
Harmonized
Guideline
885.3100;
MRID
451366
 
05).
Five
male
and
five
female
rabbits
were
dermally
treated
with
2g/
kg
body
weight
Bacillus
pumilus
strain
QST2808
Technical
for
24
hours
and
observed
for
the
following
14
days.
The
acute
lethal
dose
(
LD50)
is
greater
than
2,000
mg/
kg.
Classification:
Acceptable;
Toxicity
Category
III.
(
BPPD
Review
­
1/
7/
02).
3.
Primary
eye
irritation
(
OPPTS
Harmonized
Guideline
870.2400;
MRID
452679
 
01).
Three
male
rabbits
each
were
administered
0.1
mL
of
QST2808
Technical
in
the
everted
lower
lid
of
one
eye
and
then
observed
for
72
hours.
Based
on
the
data,
QST2808
Technical
showed
minimal
effects
to
the
eye.
Classification:
Acceptable;
Toxicity
Category
IV.
(
BPPD
Review
­
1/
7/
02).
4.
Acute
injection
toxicity/
pathogenicity
(
OPPTS
Harmonized
Guideline
885.3200;
MRID
451366
 
07).
Eighteen
male
and
eighteen
female
rats
each
were
dosed
at
1.6
x
108
cfu
Bacillus
pumilus
strain
QST2808
Technical
intravenously
and
monitored
over
a
period
of
28
days.
A
gross
necropsy
was
performed
on
all
rats.
Based
on
the
data,
the
test
organism
was
not
toxic,
infective,
or
pathogenic
to
rats.
Classification:
Acceptable.
(
BPPD
Review
­
1/
7/
02).
5.
Acute
pulmonary
toxicity/
pathogenicity
(
OPPTS
Harmonized
Guideline
885.3150;
MRID
451366
 
06).
Eighteen
male
and
eighteen
female
rats
each
were
administered
1.6
x
108
cfu
Bacillus
pumilus
strain
QST2808
Technical
by
a
single
intratracheal
dosage
and
monitored
over
a
period
of
35
days
for
clinical
signs
of
toxicity.
Necropsy
studies
showed
no
significant
signs
of
abnormalities
due
to
the
test
organism.
Based
on
the
data,
Bacillus
pumilus
strain
QST2808
was
not
toxic,
infective,
and/
or
pathogenic
to
rats
when
dosed
at
1.6
x
108
cfu/
animal.
Classification:
Acceptable.
(
BPPD
Review
­
1/
7/
02).
6.
Acute
Inhalation
toxicity
(
OPPTS
Harmonized
Guideline
870.1300).
Results
of
the
acute
pulmonary
toxicity/
pathogenicity
(
MRID
451366
 
06)
performed
with
Bacillus
pumilus
strain
QST2808
Technical
indicate
that
it
is
not
toxic,
infective,
and/
or
pathogenic
to
rats
when
dosed
at
1.6
x
108
cfu/
animal.
For
the
purposes
of
this
specific
action,
the
Agency
has
determined
that
the
acute
pulmonary
toxicity/
pathogenicity
data
are
adequate
to
support
and/
or
fulfill
this
particular
data
requirement.
7.
Primary
dermal
irritation
(
OPPTS
Harmonized
Guideline
870.2500;
MRID
452679
 
02).
Each
of
three
male
adult
rabbits
were
treated
dermally
with
0.5
mL
QST2808
Technical
for
4
hours
and
observed
for
the
following
72
hours.
Based
on
the
data,
no
abnormal
clinical
signs
were
noted.
Approximately
60
minutes
after
patch
removal,
very
slight
erythema
was
noted
on
one
of
the
three
rabbits
with
resolution
by
24
hours.
When
dosed
with
QST2808
Technical
at
0.5
mL/
animal,
QST2808
Technical
was
essentially
non­
irritating.
Classification:
Acceptable;
Toxicity
Category
IV.
(
BPPD
Review
­
1/
7/
02).
8.
Hypersensitivity
incidents
(
OPPTS
Harmonized
Guideline
885.3400).
The
registrant
reported
(
November
1,
2000)
no
incidents
to
date.
9.
Immune
response.
There
is
no
information
to
suggest
that
Bacillus
pumilus
strain
QST2808
has
an
effect
on
the
immune
system.
The
submitted
toxicity/
pathogenicity
studies
in
rodents
indicated
that
following
several
routes
of
exposure,
the
immune
system
is
still
intact
and
able
to
process
and
clear
the
active
ingredient
(
MRID
451366
 
04;
451366
 
06,
and
451366
 
07).
Based
on
the
data
generated
in
accordance
with
the
Tier
I
data
requirements
set
forth
in
40
CFR
§
158.740(
c),
the
Tier
II
and
Tier
III
data
requirements
were
not
triggered
and,
therefore,
not
required
in
connection
with
this
action.
In
addition,
because
the
Tier
II
and
Tier
III
data
requirements
were
not
required,
the
residue
data
requirements
set
forth
in
40
CFR
§
158.740(
b)
also
were
not
required.

IV.
Aggregate
Exposures
In
examining
aggregate
exposure,
section
408
of
the
FFDCA
directs
EPA
to
consider
available
information
concerning
exposures
from
the
pesticide
residue
in
food
and
all
other
nonoccupational
exposures,
including
drinking
water
from
ground
water
or
surface
water
and
exposure
through
pesticide
use
in
gardens,
lawns,
or
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/
Vol.
68,
No.
117
/
Wednesday,
June
18,
2003
/
Rules
and
Regulations
buildings
(
residential
and
other
indoor
uses).

A.
Dietary
Exposure
Humans
and
animals
are
commonly
exposed
to
Bacillus
pumilus,
a
ubiquitous
microorganism
that
inhabits
soil.
No
toxicological
endpoints
were
identified
for
Bacillus
pumilus
strain
QST2808.
The
low
toxicity
and
nonpathogenicity
infectivity
of
Bacillus
pumilus
strain
QST2808
is
demonstrated
by
the
data
summarized
in
Unit
III
of
this
action.
1.
Food.
While
the
proposed
use
pattern
may
result
in
dietary
exposure
with
possible
residues
in
or
on
agricultural
commodities,
negligible
to
no
risk
is
expected
for
the
general
population,
including
infants
and
children,
or
animals
because
Bacillus
pumilus
strain
QST2808
technical
demonstrated
no
pathogenicity
or
oral
toxicity
at
the
maximum
doses
tested,
as
noted
above
in
(
Unit
III).
2.
Drinking
water
exposure.
Most
importantly,
there
is
no
evidence
of
adverse
effects
from
oral,
dermal,
or
inhalation
exposure
to
this
microbial
agent.
(
See
``
Unit
III.
Toxicological
Profile''
above.)
In
addition,
the
potential
for
transfer
of
Bacillus
pumilus
strain
QST2808
to
surface
or
ground
water
during
run­
off
associated
with
intended
use
applications
is
considered
minimal
to
non­
existent,
due
in
part
to
its
percolation
through
and
resulting
capture
in
soil.
Accordingly,
the
use
of
this
microbial
pest
control
agent
on
terrestrial
plants
is
not
anticipated
to
negatively
impact
the
quality
of
drinking
water.

B.
Other
Non­
Occupational
Exposure
Based
on
the
proposed
use
patterns,
the
potential
of
non­
dietary
exposures
to
Bacillus
pumilus
strain
QST2808
pesticide
residues
for
the
general
population,
including
infants
and
children,
is
unlikely.
Accordingly,
the
Agency
believes
that
the
potential
aggregate
non­
occupational
exposure,
derived
from
dermal
and
inhalation
exposure
through
the
application
of
Bacillus
pumilus
strain
QST2808,
should
fall
well
below
the
currently
tested
microbial
safety
levels.
1.
Dermal
exposure.
The
potential
for
dermal
exposure
to
Bacillus
pumilus
strain
QST2808
pesticide
residues
for
the
general
population,
including
infants
and
children,
is
unlikely
because
potential
use
sites
are
agricultural
and
horticultural.
However,
since
Bacillus
pumilus
strain
QST2808
is
a
naturally
occurring
bacteria
in
soil,
there
is
a
great
likelihood
of
prior
exposure
for
most,
if
not
all
individuals.
Accordingly,
the
increase
in
exposure
due
to
this
proposed
product
would
be
negligible.
Furthermore,
and
as
demonstrated
in
Unit
III
of
this
action,
the
organism
is
of
low
dermal
toxicity,
the
acute
lethal
dose
(
LD50)
is
greater
than
2,000
mg/
kg,
and
the
QST2808
Technical
was
essentially
non­
irritating
(
Toxicity
Category
IV).
Accordingly,
the
risks
anticipated
for
this
route
of
exposure
are
considered
minimal.
2.
Inhalation
exposure.
The
potential
for
inhalation
exposure
to
Bacillus
pumilus
strain
QST2808
pesticide
residues
for
the
general
population,
including
infants
and
children
is
unlikely
because
potential
use
sites
are
agricultural
and
horticultural.
However,
since
Bacillus
pumilus
is
a
natural
occurring
bacteria
in
soil,
there
is
a
great
likelihood
of
prior
exposure
for
most,
if
not
all
individuals.
Accordingly,
the
increase
in
exposure
due
to
this
proposed
product
would
be
negligible.
Furthermore,
and
as
demonstrated
in
Unit
III
of
this
action,
the
acute
pulmonary
toxicity/
pathogenicity
testing
performed
on
the
technical
formulation
did
not
demonstrate
pathogenicity
or
toxicity
of
Bacillus
pumilus
strain
QST2808.
(
See
Unit
III
above.)
Accordingly,
the
risks
anticipated
for
this
route
of
exposure
are
considered
minimal.

V.
Cumulative
Effects
The
Agency
has
considered
the
potential
for
cumulative
effects
of
Bacillus
pumilus
strain
QST2808
and
other
substances
in
relation
to
a
common
mechanism
of
toxicity.
These
considerations
include
the
possible
cumulative
effects
of
such
residues
on
infants
and
children.
Bacillus
pumilus
strain
QST2808
is
practically
non­
toxic
to
mammals.
Because
no
mechanism
of
pathogenicity
or
toxicity
in
mammals
has
been
identified
for
this
organism
(
see
Unit
III
above),
no
cumulative
effects
from
the
residues
of
this
product
with
other
related
microbial
pesticides
is
anticipated.

VI.
Determination
of
Safety
for
U.
S.
Population,
Infants
and
Children
There
is
a
reasonable
certainty
that
no
harm
to
the
U.
S.
population,
including
infants
and
children,
will
result
from
aggregate
exposure
to
residues
of
Bacillus
pumilus
strain
QST2808
due
to
its
use
as
a
microbial
pest
control
agent.
This
includes
all
anticipated
dietary
exposures
and
all
other
exposures
for
which
there
is
reliable
information.
As
discussed
previously,
Bacillus
pumilus
strain
QST2808
is
not
pathogenic
or
infective
and
is
practically
non­
toxic
to
mammals.
(
See
Unit
III
above.)
Accordingly,
exempting
Bacillus
pumilus
strain
QST
2808
from
the
requirement
of
a
tolerance
should
be
considered
safe
and
pose
no
significant
risk.
FFDCA
section
408(
b)(
2)(
C)
provides
that
EPA
shall
apply
an
additional
tenfold
margin
of
exposure
(
safety)
for
infants
and
children
in
the
case
of
threshold
effects
to
account
for
prenatal
and
postnatal
toxicity
and
the
completeness
of
the
data
base
on
toxicity
and
exposure,
unless
EPA
determines
that
a
different
margin
of
exposure
(
safety)
will
be
safe
for
infants
and
children.
Margins
of
exposure
(
safety)
are
incorporated
into
EPA
risk
assessments
either
directly
through
the
use
of
a
margin
of
exposure
analysis
or
by
using
uncertainty
(
safety)
factors
in
calculating
a
dose
level
that
poses
no
appreciable
risk
to
humans.
Due
to
the
ubiquitous
nature
of
Bacillus
pumilus,
residues
of
this
microbial
pesticide
in
or
on
agricultural
commodities
are
not
expected
to
significantly
increase
exposure
to
the
U.
S.
population,
including
infants
and
children.
Here,
EPA
concludes
that
the
toxicity
and
exposure
data
are
sufficiently
complete
to
adequately
address
the
potential
for
additional
sensitivity
of
infants
and
children
to
residues
of
Bacillus
pumilus
strain
QST2808
and
that
there
is
a
reasonable
certainty
that
no
harm
will
result
to
infants
and
children
from
aggregate
exposure
to
Bacillus
pumilus
strain
QST2808
residues.

VII.
Other
Considerations
A.
Endocrine
Disruptors
EPA
is
required
under
section
408(
p)
of
the
FFDCA,
as
amended
by
FQPA,
to
develop
a
screening
program
to
determine
whether
certain
substances
(
including
all
pesticide
active
and
other
ingredients)
``
may
have
an
effect
in
humans
that
is
similar
to
an
effect
produced
by
a
naturally­
occurring
estrogen,
or
other
such
endocrine
effects
as
the
Administrator
may
designate.''
Following
the
recommendations
of
its
Endocrine
Disruptor
Screening
and
Testing
Advisory
Committee
(
EDSTAC),
EPA
determined
that
there
is
no
scientific
basis
for
including,
as
part
of
the
screening
program,
the
androgen
and
thyroid
hormone
systems
in
addition
to
the
estrogen
hormone
system.
EPA
also
adopted
EDSTAC's
recommendation
that
the
program
include
evaluations
of
potential
effects
in
wildlife.
For
pesticide
chemicals,
EPA
will
use
FIFRA
and,
to
the
extent
that
effects
in
wildlife
may
help
determine
whether
a
substance
may
have
an
effect
in
humans,
FFDCA
authority
to
require
wildlife
evaluations.
As
the
science
develops
and
resources
allow,
screening
of
additional
hormone
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/
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/
Wednesday,
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18,
2003
/
Rules
and
Regulations
systems
may
be
added
to
the
Endocrine
Disruptor
Screening
Program
(
EDSP).
When
the
appropriate
screening
and/
or
testing
protocols
being
considered
under
the
Agency's
EDSP
have
been
developed,
Bacillus
pumilus
strain
QST2808
may
be
subjected
to
additional
screening
and/
or
testing
to
better
characterize
effects
related
to
endocrine
disruption.
To
date,
the
Agency
has
no
information
to
suggest
that
Bacillus
pumilus
strain
QST2808
has
an
effect
on
the
endocrine
systems.
Moreover,
as
is
expected
from
a
non­
pathogenic
microorganism
that
is
practically
nontoxic
to
mammals,
the
submitted
toxicity/
pathogenicity
studies
in
rodents
indicated
that
following
several
routes
of
exposure,
the
immune
system
is
still
intact
and
able
to
process
and
clear
the
active
ingredient.
(
BPPD
Review
­
1/
7/
02).

B.
Analytical
Method
The
Agency
proposes
to
establish
an
exemption
from
the
requirement
of
a
tolerance
without
any
numerical
limitation
for
the
reasons
stated
above,
including
Bacillus
pumilus
strain
QST2808'
s
lack
of
mammalian
toxicity.
For
the
same
reasons,
the
Agency
has
concluded
that
an
analytical
method
is
not
required
for
enforcement
purpose
for
Bacillus
pumilus
strain
QST2808.

C.
Codex
Maximum
Residue
Level
There
is
no
Codex
Alimentarius
Commission
Maximum
Residue
Level
for
Bacillus
pumilus
strain
QST2808.

VIII.
Objections
and
Hearing
Requests
Under
section
408(
g)
of
the
FFDCA,
as
amended
by
the
FQPA,
any
person
may
file
an
objection
to
any
aspect
of
this
regulation
and
may
also
request
a
hearing
on
those
objections.
The
EPA
procedural
regulations
which
govern
the
submission
of
objections
and
requests
for
hearings
appear
in
40
CFR
part
178.
Although
the
procedures
in
those
regulations
require
some
modification
to
reflect
the
amendments
made
to
the
FFDCA
by
the
FQPA,
EPA
will
continue
to
use
those
procedures,
with
appropriate
adjustments,
until
the
necessary
modifications
can
be
made.
The
new
section
408(
g)
of
the
FFDCA
provides
essentially
the
same
process
for
persons
to
``
object''
to
a
regulation
for
an
exemption
from
the
requirement
of
a
tolerance
issued
by
EPA
under
new
section
408(
d),
as
was
provided
in
the
old
sections
408
and
409
of
the
FFDCA.
However,
the
period
for
filing
objections
is
now
60
days,
rather
than
30
days.
A.
What
Do
I
Need
to
Do
to
File
an
Objection
or
Request
a
Hearing?

You
must
file
your
objection
or
request
a
hearing
on
this
regulation
in
accordance
with
the
instructions
provided
in
this
unit
and
in
40
CFR
part
178.
To
ensure
proper
receipt
by
EPA,
you
must
identify
docket
ID
number
OPP
 
2003
 
0113
in
the
subject
line
on
the
first
page
of
your
submission.
All
objections
and
requests
for
hearings
must
be
in
writing,
and
must
be
mailed
or
delivered
to
the
Hearing
Clerk
on
or
before
August
18,
2003.
1.
Filing
the
request.
Your
objection
must
specify
the
specific
provisions
in
the
regulation
that
you
object
to,
and
the
grounds
for
the
objections
(
40
CFR
178.25).
If
a
hearing
is
requested,
the
objections
must
include
a
statement
of
the
factual
issues(
s)
on
which
a
hearing
is
requested,
the
requestor's
contentions
on
such
issues,
and
a
summary
of
any
evidence
relied
upon
by
the
objector
(
40
CFR
178.27).
Information
submitted
in
connection
with
an
objection
or
hearing
request
may
be
claimed
confidential
by
marking
any
part
or
all
of
that
information
as
CBI.
Information
so
marked
will
not
be
disclosed
except
in
accordance
with
procedures
set
forth
in
40
CFR
part
2.
A
copy
of
the
information
that
does
not
contain
CBI
must
be
submitted
for
inclusion
in
the
public
record.
Information
not
marked
confidential
may
be
disclosed
publicly
by
EPA
without
prior
notice.
Mail
your
written
request
to:
Office
of
the
Hearing
Clerk
(
1900C),
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460
 
0001.
You
may
also
deliver
your
request
to
the
Office
of
the
Hearing
Clerk
in
Rm.
104,
Crystal
Mall
#
2,
1921
Jefferson
Davis
Hwy.,
Arlington,
VA.
The
Office
of
the
Hearing
Clerk
is
open
from
8
a.
m.
to
4
p.
m.,
Monday
through
Friday,
excluding
legal
holidays.
The
telephone
number
for
the
Office
of
the
Hearing
Clerk
is
(
703)
603
 
0061.
2.
Tolerance
fee
payment.
If
you
file
an
objection
or
request
a
hearing,
you
must
also
pay
the
fee
prescribed
by
40
CFR
180.33(
i)
or
request
a
waiver
of
that
fee
pursuant
to
40
CFR
180.33(
m).
You
must
mail
the
fee
to:
EPA
Headquarters
Accounting
Operations
Branch,
Office
of
Pesticide
Programs,
P.
O.
Box
360277M,
Pittsburgh,
PA
15251.
Please
identify
the
fee
submission
by
labeling
it
``
Tolerance
Petition
Fees.''
EPA
is
authorized
to
waive
any
fee
requirement
``
when
in
the
judgement
of
the
Administrator
such
a
waiver
or
refund
is
equitable
and
not
contrary
to
the
purpose
of
this
subsection.''
For
additional
information
regarding
the
waiver
of
these
fees,
you
may
contact
James
Tompkins
by
phone
at
(
703)
305
 
5697,
by
e­
mail
at
tompkins.
jim@
epa.
gov,
or
by
mailing
a
request
for
information
to
Mr.
Tompkins
at
Registration
Division
(
7505C),
Office
of
Pesticide
Programs,
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460
 
0001.
If
you
would
like
to
request
a
waiver
of
the
tolerance
objection
fees,
you
must
mail
your
request
for
such
a
waiver
to:
James
Hollins,
Information
Resources
and
Services
Division
(
7502C),
Office
of
Pesticide
Programs,
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460
 
0001.
3.
Copies
for
the
Docket.
In
addition
to
filing
an
objection
or
hearing
request
with
the
Hearing
Clerk
as
described
in
Unit
VIII.
A.,
you
should
also
send
a
copy
of
your
request
to
the
PIRIB
for
its
inclusion
in
the
official
record
that
is
described
in
Unit
I.
B.
1.
Mail
your
copies,
identified
by
docket
ID
number
OPP
 
2003
 
0113,
to:
Public
Information
and
Records
Integrity
Branch,
Information
Resources
and
Services
Division
(
7502C),
Office
of
Pesticide
Programs,
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460
 
0001.
In
person
or
by
courier,
bring
a
copy
to
the
location
of
the
PIRIB
described
in
Unit
I.
B.
1.
You
may
also
send
an
electronic
copy
of
your
request
via
e­
mail
to:
oppdocket
epa.
gov.
Please
use
an
ASCII
file
format
and
avoid
the
use
of
special
characters
and
any
form
of
encryption.
Copies
of
electronic
objections
and
hearing
requests
will
also
be
accepted
on
disks
in
WordPerfect
6.1/
8.0
or
ASCII
file
format.
Do
not
include
any
CBI
in
your
electronic
copy.
You
may
also
submit
an
electronic
copy
of
your
request
at
many
Federal
Depository
Libraries.

B.
When
Will
the
Agency
Grant
a
Request
for
a
Hearing?

A
request
for
a
hearing
will
be
granted
if
the
Administrator
determines
that
the
material
submitted
shows
the
following:
There
is
a
genuine
and
substantial
issue
of
fact;
there
is
a
reasonable
possibility
that
available
evidence
identified
by
the
requestor
would,
if
established
resolve
one
or
more
of
such
issues
in
favor
of
the
requestor,
taking
into
account
uncontested
claims
or
facts
to
the
contrary;
and
resolution
of
the
factual
issues(
s)
in
the
manner
sought
by
the
requestor
would
be
adequate
to
justify
the
action
requested
(
40
CFR
178.32).

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Federal
Register
/
Vol.
68,
No.
117
/
Wednesday,
June
18,
2003
/
Rules
and
Regulations
IX.
Statutory
and
Executive
Order
Reviews
This
final
rule
establishes
a
temporary
exemption
from
the
tolerance
requirement
for
Bacillus
pumilus
strain
QST2808
under
section
408(
d)
of
the
FFDCA
in
response
to
a
petition
submitted
to
the
Agency.
The
Office
of
Management
and
Budget
(
OMB)
has
exempted
these
types
of
actions
from
review
under
Executive
Order
12866,
entitled
Regulatory
Planning
and
Review
(
58
FR
51735,
October
4,
1993).
Because
this
rule
has
been
exempted
from
review
under
Executive
Order
12866
due
to
its
lack
of
significance,
this
rule
is
not
subject
to
Executive
Order
13211,
Actions
Concerning
Regulations
That
Significantly
Affect
Energy
Supply,
Distribution,
or
Use
(
66
FR
28355,
May
22,
2001).
This
final
rule
does
not
contain
any
information
collections
subject
to
OMB
approval
under
the
Paperwork
Reduction
Act
(
PRA),
44
U.
S.
C.
3501
et
seq.,
or
impose
any
enforceable
duty
or
contain
any
unfunded
mandate
as
described
under
Title
II
of
the
Unfunded
Mandates
Reform
Act
of
1995
(
UMRA)
(
Public
Law
104
 
4).
Nor
does
it
require
any
special
considerations
under
Executive
Order
12898,
entitled
Federal
Actions
to
Address
Environmental
Justice
in
Minority
Populations
and
Low­
Income
Populations
(
59
FR
7629,
February
16,
1994);
or
OMB
review
or
any
Agency
action
under
Executive
Order
13045,
entitled
Protection
of
Children
from
Environmental
Health
Risks
and
Safety
Risks
(
62
FR
19885,
April
23,
1997).
This
action
does
not
involve
any
technical
standards
that
would
require
Agency
consideration
of
voluntary
consensus
standards
pursuant
to
section
12(
d)
of
the
National
Technology
Transfer
and
Advancement
Act
of
1995
(
NTTAA),
Public
Law
104
 
113,
section
12(
d)
(
15
U.
S.
C.
272
note).
Since
tolerances
and
exemptions
that
are
established
on
the
basis
of
a
petition
under
section
408(
d)
of
the
FFDCA,
such
as
the
exemption
in
this
final
rule,
do
not
require
the
issuance
of
a
proposed
rule,
the
requirements
of
the
Regulatory
Flexibility
Act
(
RFA)
(
5
U.
S.
C.
601
et
seq.)
do
not
apply.
In
addition,
the
Agency
has
determined
that
this
action
will
not
have
a
substantial
direct
effect
on
States,
on
the
relationship
between
the
national
government
and
the
States,
or
on
the
distribution
of
power
and
responsibilities
among
the
various
levels
of
government,
as
specified
in
Executive
Order
13132,
entitled
Federalism
(
64
FR
43255,
August
10,
1999).
Executive
Order
13132
requires
EPA
to
develop
an
accountable
process
to
ensure
``
meaningful
and
timely
input
by
State
and
local
officials
in
the
development
of
regulatory
policies
that
have
federalism
implications.''
``
Policies
that
have
federalism
implications''
is
defined
in
the
Executive
Order
to
include
regulations
that
have
``
substantial
direct
effects
on
the
States,
on
the
relationship
between
the
national
government
and
the
States,
or
on
the
distribution
of
power
and
responsibilities
among
the
various
levels
of
government.''
This
final
rule
directly
regulates
growers,
food
processors,
food
handlers
and
food
retailers,
not
States.
This
action
does
not
alter
the
relationships
or
distribution
of
power
and
responsibilities
established
by
Congress
in
the
preemption
provisions
of
section
408(
n)(
4)
of
the
FFDCA.
For
these
same
reasons,
the
Agency
has
determined
that
this
rule
does
not
have
any
``
tribal
implications''
as
described
in
Executive
Order
13175,
entitled
Consultation
and
Coordination
with
Indian
Tribal
Governments
(
65
FR
67249,
November
6,
2000).
Executive
Order
13175,
requires
EPA
to
develop
an
accountable
process
to
ensure
``
meaningful
and
timely
input
by
tribal
officials
in
the
development
of
regulatory
policies
that
have
tribal
implications.''
``
Policies
that
have
tribal
implications''
is
defined
in
the
Executive
Order
to
include
regulations
that
have
``
substantial
direct
effects
on
one
or
more
Indian
tribes,
on
the
relationship
between
the
Federal
Government
and
the
Indian
tribes,
or
on
the
distribution
of
power
and
responsibilities
between
the
Federal
Government
and
Indian
tribes.''
This
rule
will
not
have
substantial
direct
effects
on
tribal
governments,
on
the
relationship
between
the
Federal
Government
and
Indian
tribes,
or
on
the
distribution
of
power
and
responsibilities
between
the
Federal
government
and
Indian
tribes,
as
specified
in
Executive
Order
13175.
Thus,
Executive
Order
13175
does
not
apply
to
this
rule.

X.
Congressional
Review
Act
The
Congressional
Review
Act,
5
U.
S.
C.
801
et
seq.,
as
added
by
the
Small
Business
Regulatory
Enforcement
Fairness
Act
of
1996,
generally
provides
that
before
a
rule
may
take
effect,
the
agency
promulgating
the
rule
must
submit
a
rule
report,
which
includes
a
copy
of
the
rule,
to
each
House
of
the
Congress
and
to
the
Comptroller
General
of
the
United
States.
EPA
will
submit
a
report
containing
this
rule
and
other
required
information
to
the
U.
S.
Senate,
the
U.
S.
House
of
Representatives,
and
the
Comptroller
General
of
the
United
States
prior
to
publication
of
this
final
rule
in
the
Federal
Register.
This
final
rule
is
not
a
``
major
rule
''
as
defined
by
5
U.
S.
C.
804(
2).

List
of
Subjects
in
40
CFR
Part
180
Environmental
protection,
Administrative
practice
and
procedure,
Agricultural
commodities,
Pesticides
and
pests,
Reporting
and
recordkeeping
requirements.

Dated:
June
3,
2003.
James
Jones,
Director,
Office
of
Pesticide
Programs.


Therefore,
40
CFR
chapter
I
is
amended
as
follows:

PART
180
 
[
AMENDED]


1.
The
authority
citation
for
part
180
continues
to
read
as
follows:

Authority:
21
U.
S.
C.
321(
q),
346(
a)
and
371.


2.
Section
180.1226
is
added
to
subpart
D
to
read
as
follows:

§
180.1226
Bacillus
pumilus
strain
QST2808;
temporary
exemption
from
the
requirement
of
a
tolerance.
A
temporary
exemption
from
the
requirement
of
a
tolerance
is
established
for
residues
of
the
microbial
pesticide
Bacillus
pumilus
strain
QST2808
when
used
in
or
on
all
agricultural
commodities
when
applied/
used
in
accordance
with
label
directions.

[
FR
Doc.
03
 
15129
Filed
6
 
17
 
03;
8:
45
am]

BILLING
CODE
6560
 
50
 
S
ENVIRONMENTAL
PROTECTION
AGENCY
40
CFR
Part
180
[
OPP
 
2003
 
0196;
FRL
 
7311
 
2]

Azoxystrobin;
Pesticide
Tolerance
AGENCY:
Environmental
Protection
Agency
(
EPA).
ACTION:
Final
rule.

SUMMARY:
This
regulation
establishes
tolerances
for
combined
residues
of
azoxystrobin,
methyl
(
E)­
2­[[
6­(
2­
cyanophenoxy)­
4­
pyrimidinyl]
oxy]­ ­
(
methoxymethylene)­
benzeneacetate,
and
its
Z
isomer,
methyl
(
Z)­
2­[[
6­(
2­
cyanophenoxy)­
4­
pyrimidinyl]
oxy]­
 (
methoxymethylene)­
benzeneacetate,
in
or
on
artichoke,
globe;
asparagus;
brassica,
head
and
stem,
subgroup
5A;
herb
subgroup
19A,
(
dried)
except
chive;
and
herb
subgroup
19A,
(
fresh)
except
chive.
Interregional
Research
Project
Number
4
(
IR­
4)
requested
these
tolerances
under
the
Federal
Food,
Drug,
and
Cosmetic
Act
(
FFDCA),
as
amended
by
the
Food
Quality
Protection
Act
of
1996
(
FQPA).

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