Document ID: EPA-HQ-OPP-2002-0233-0001
Agency: epa
Document Type: Rule
Title: Pseudozyma Flocculosa Strain PF-A22 UL; Exemption From the Requirement of a Tolerance.
Posted Date: 2002-09-27T04:00Z

60960
Federal
Register
/
Vol.
67,
No.
188
/
Friday,
September
27,
2002
/
Rules
and
Regulations
Commodity
Parts
per
million
Barley,
grain
.............................
0.05
Barley,
hay
................................
0.05
Barley,
straw
.............................
0.05
Wheat,
forage
...........................
0.05
Wheat,
grain
.............................
0.05
Wheat,
hay
...............................
0.05
Wheat,
straw
.............................
0.05
(b)
Section
18
emergency
exemptions.
[Reserved]
(c)
Tolerances
with
regional
registrations.
[Reserved]
(d)
Indirect
or
inadvertent
residues.
[Reserved]

[FR
Doc.
02–
24650
Filed
9–
26–
02;
8:
45
am]

BILLING
CODE
6560–
50–
S
ENVIRONMENTAL
PROTECTION
AGENCY
40
CFR
Part
180
[OPP–
2002–
0233;
FRL–
7198–
8]

Pseudozyma
flocculosa
strain
PF­
A22
UL;
Exemption
from
the
Requirement
of
a
Tolerance
AGENCY:
Environmental
Protection
Agency
(EPA).
ACTION:
Final
rule.

SUMMARY:
This
regulation
establishes
an
exemption
from
the
requirement
of
a
tolerance
for
residues
of
the
Pseudozyma
flocculosa
strain
PF­
A22
UL
in
or
on
all
food
commodities.
Plant
Products
Co.
Ltd.,
submitted
a
petition
to
EPA
under
the
Federal
Food,
Drug,
and
Cosmetic
Act,
as
amended
by
the
Food
Quality
Protection
Act
of
1996,
requesting
an
exemption
from
the
requirement
of
a
tolerance.
This
regulation
eliminates
the
need
to
establish
a
maximum
permissible
level
for
residues
of
Pseudozyma
flocculosa
strain
PF­
A22
UL.
DATES:
This
regulation
is
effective
September
27,
2002.
Objections
and
requests
for
hearings,
identified
by
docket
ID
number
OPP–
2002–
0233,
must
be
received
on
or
before
November
26,
2002.
ADDRESSES:
Written
objections
and
hearing
requests
may
be
submitted
by
mail,
electronically,
or
in
person.
Please
follow
the
detailed
instructions
for
each
method
as
provided
in
Unit
IX.
of
the
SUPPLEMENTARY
INFORMATION.
To
ensure
proper
receipt
by
EPA,
your
objections
and
hearing
requests
must
identify
docket
ID
number
OPP–
2002–
0233
in
the
subject
line
on
the
first
page
of
your
response.
FOR
FURTHER
INFORMATION
CONTACT:
By
mail:
Sharlene
R.
Matten,
c/
o
Product
Manager
(PM)
90,
Biopesticides
and
Pollution
Prevention
Division
(7511C),
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460;
telephone
number:
(703)
605–
0514;
e­
mail
address:
matten.
sharlene@
epa.
gov.

SUPPLEMENTARY
INFORMATION:

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

You
may
be
affected
by
this
action
if
you
are
an
agricultural
producer,
food
manufacturer,
or
pesticide
manufacturer.
Potentially
affected
categories
and
entities
may
include,
but
are
not
limited
to:

Categories
NAICS
codes
Examples
of
potentially
affected
entities
Industry
111
Crop
production
112
Animal
production
311
Food
manufacturing
32532
Pesticide
manufacturing
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
the
table
could
also
be
affected.
The
North
American
Industrial
Classification
System
(NAICS)
codes
have
been
provided
to
assist
you
and
others
in
determining
whether
or
not
this
action
might
apply
to
certain
entities.
If
you
have
questions
regarding
the
applicability
of
this
action
to
a
particular
entity,
consult
the
person
listed
under
FOR
FURTHER
INFORMATION
CONTACT.

B.
How
Can
I
Get
Additional
Information,
Including
Copies
of
this
Document
and
Other
Related
Documents?

1.
Electronically.
You
may
obtain
electronic
copies
of
this
document,
and
certain
other
related
documents
that
might
be
available
electronically,
from
the
EPA
Internet
Home
Page
at
http://
www.
epa.
gov/.
To
access
this
document,
on
the
Home
Page
select
``
Laws
and
Regulations,
''
``
Regulations
and
Proposed
Rules,
''
and
then
look
up
the
entry
for
this
document
under
the
``
Federal
Register—
Environmental
Documents.
''
You
can
also
go
directly
to
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.
2.
In
person.
The
Agency
has
established
an
official
record
for
this
action
under
docket
ID
number
OPP–
2002–
0233.
The
official
record
consists
of
the
documents
specifically
referenced
in
this
action,
and
other
information
related
to
this
action,
including
any
information
claimed
as
Confidential
Business
Information
(CBI).
This
official
record
includes
the
documents
that
are
physically
located
in
the
docket,
as
well
as
the
documents
that
are
referenced
in
those
documents.
The
public
version
of
the
official
record
does
not
include
any
information
claimed
as
CBI.
The
public
version
of
the
official
record,
which
includes
printed,
paper
versions
of
any
electronic
comments
submitted
during
an
applicable
comment
period
is
available
for
inspection
in
the
Public
Information
and
Records
Integrity
Branch
(PIRIB),
Rm.
119,
Crystal
Mall
#2,
1921
Jefferson
Davis
Hwy.,
Arlington,
VA,
from
8:
30
a.
m.
to
4
p.
m.,
Monday
through
Friday,
excluding
legal
holidays.
The
PIRIB
telephone
number
is
(703)
305–
5805.

II.
Background
and
Statutory
Findings
In
the
Federal
Register
of
August
30,
2000
(65
FR
52749)
(FRL–
6739–
8),
EPA
issued
a
notice
pursuant
to
section
408
of
the
Federal
Food,
Drug,
and
Cosmetic
Act
(FFDCA),
21
U.
S.
C.
346a(
d),
as
amended
by
the
Food
Quality
Protection
Act
(FQPA)
(Public
Law
104–
170),
announcing
the
filing
of
a
pesticide
tolerance
petition
(PP
0F6136)
by
Plant
Products
Co.
Ltd.,
f314
Orenda
Rd.,
Brampton,
Ontario,
Canada
L6T
1G1.
This
notice
included
a
summary
of
the
petition
prepared
by
the
petitioner
Plant
Products
Co.
Ltd.
There
were
no
comments
received
in
response
to
the
notice
of
filing.
The
petition
requested
that
40
CFR
part
180
be
amended
by
establishing
an
exemption
from
the
requirement
of
a
tolerance
for
residues
of
Pseudozyma
flocculosa
strain
PF­
A22
UL
in
or
on
all
food
commodities.

III.
Risk
Assessment
New
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
determines
that
the
tolerance
is
``
safe.
''
Section
408(
c)(
2)(
A)(
ii)
defines
``
safe''
to
mean
that
``
there
is
a
reasonable
certainty
that
no
harm
will
result
from
aggregate
exposure
to
the
VerDate
Sep<
04>
2002
16:
57
Sep
26,
2002
Jkt
197001
PO
00000
Frm
00108
Fmt
4700
Sfmt
4700
E:\
FR\
FM\
27SER1.
SGM
27SER1
60961
Federal
Register
/
Vol.
67,
No.
188
/
Friday,
September
27,
2002
/
Rules
and
Regulations
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)
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)
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.

IV.
Toxicological
Profile
Consistent
with
section
408(
b)(
2)(
D)
of
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.
Pseudozyma
flocculosa
was
isolated
in
1986
from
the
leaves
of
red
clover,
Trifolium
pratense,
infected
with
powdery
mildew,
Erysiphe
polygoni,
by
researchers
at
Agriculture
and
AgriFood
Canada,
Harrow,
Ontario.
Initially,
this
organism
was
erroneously
identified
as
a
new
ascomycetous
yeast
with
an
anamorphic
state
in
the
broad
genus
Sporothrix
and
a
teleomorphic
state
in
the
genus
Stephanoascus.
In
1995,
its
taxon
was
changed
to
P.
flocculosa
following
ribosomal
DNA
analysis.
The
genus
Pseudozyma
contains
other
smut­
like
anamorphs,
including
P.
rugulosa
(formerly
Sporothrix
rugulosa).
P.
flocculosa
is
a
phyllosphere
epiphyte
and
hyperparasite
of
primarily
powdery
mildew
but
has
been
isolated
in
association
with
other
leaf­
surface
molds.
It
is
widely
distributed
in
North
America
(Canada
and
USA)
and
in
Europe
on
aerial
plant
surfaces
in
field
or
greenhouse
agricultural
ecosystems.
P.
flocculosa
antagonizes
a
number
of
different
powdery
mildew
fungi
(Sphaerotheca
pannosa
var.
rosae,
Sphaerotheca
fulginea,
Erysiphe
graminis
var.
tritici
and
Erysiphe
polygoni)
on
many
different
plants
in
greenhouse
and
field
environments
when
the
relative
humidity
is
greater
or
equal
to
70%.
This
fungus
is
a
necrotroph
mycoparasite
that
kills
susceptible
target
host
cells
upon
contact
or
in
close
proximity.
Rapid
death
and
collapse
of
host
cells
without
penetration
is
brought
about
by
the
secretion
of
three
fungitoxic
unsaturated
C­
17
fatty
acids
(9­
heptadecenoic
acid,
6­
methyl­
9­
heptadecenoic
acid
and
4­
methyl­
7,11­
heptadecadienoic
acid)
and
an
acyclic
norterpene
(2,
6,
10,
14,
18­
pentamethyl­
2,
6,
8,
10,
12,
14,
17­
nonadecaheptene­
1,19­
diol).
The
fungitoxins
disrupt
susceptible
plasma
membranes
and
cytoplasmic
organelles
within
30
minutes
of
exposure.
The
inhibitory
response
includes
a
loss
of
proteins
and
electrolytes.
After
24
hours,
the
host
cells
rapidly
collapse
and
die
as
a
result
of
the
activity
of
the
fungitoxins
on
the
host
cell's
membranes
and
lipids.
Sensitivity
to
the
unsaturated
C­
17
free
fatty
acids
is
related
to
a
high
degree
of
unsaturation
of
phospholipid
fatty
acids
and
a
low
proportion
of
sterols.
P.
flocculosa
strain
PF­
A22
UL
was
considered
of
low
toxicity
and
no
pathogenicity
based
on
the
results
of
the
Tier
I
toxicology
studies.
Tier
II
and
Tier
III
studies
were
not
required
because
the
results
from
the
Tier
I
studies
were
sufficient
to
satisfy
guideline
requirements.
On
the
basis
of
the
studies
submitted,
it
was
considered
a
Toxicity
Category
III
pesticide
for
acute
oral
effects
due
to
the
amount
dosed
only,
and
Toxicity
Category
IV
for
dermal
and
primary
dermal
irritation
health
effects.
These
and
additional
toxicology
studies
are
summarized
below
and
in
more
detail
in
the
Product
Monograph
for
Pseudozyma
flocculosa
strain
PF­
A22
UL
which
is
found
in
the
OPP
docket
number
OPP–
2002–
0233.
1.
Acute
oral
toxicity/
pathogenicity
study
(OPPTS
885.3050)
(Master
Record
Identification
(MRID)
numbers
451152–
04
and
453634–
01).
No
signs
of
toxicity
or
pathogenicity
were
noted
when
Sporodex
WP,
a
wettable
powder
formulation
containing
2.0%
(weight/
weight)
P.
flocculosa
strain
PF­
A22
UL
was
administered
to
rats
via
the
oral
route.
In
an
acute
oral
toxicity
study,
groups
of
fasted
6­
7
week
old
Fisher
344
rats
(12/
sex)
were
administered
a
single
oral
dose
of
Sporodex
WP
in
USP
sterile
water
for
injection
at
doses
of
5.8
x
10
8
colony­
forming
units
(CFU)
per
animal
for
males
and
5.6
x
10
8
CFU
per
animal
for
females.
An
equal
number
of
animals
were
dosed
with
heat­
killed
test
substance
and
four
animals/
sex
served
as
untreated
controls.
The
animals
were
then
observed
for
a
period
of
up
to
21
days
with
interim
scheduled
sacrifices.
No
effect
on
body
weight
gain
and
no
apparent
signs
of
treatment­
related
toxicity,
infectivity
or
pathogenicity
were
observed
in
any
of
the
treated
animals
during
the
study
period.
Clearance
of
the
test
organism
occurred
by,
or
prior
to,
post­
treatment
day
7.
Based
on
the
results
of
this
study,
Sporodex
L
and
its
active
ingredient,
P.
flocculosa,
is
not
considered
toxic
or
pathogenic
to
male
or
female
Fisher
344
rats.
2.
Acute
pulmonary
toxicity/
pathogenicity
study
(OPPTS
885.3150)
(MRID
numbers
451152–
06
and
453634–
01).
The
potential
toxicity
and
pathogenicity
of
P.
flocculosa
was
tested
by
observing
the
effects
following
a
single
intratracheal
instillation
of
3.2
x
10
7
CFU
of
the
test
organism
(TS)
to
each
of
12
male
and
12
female
CD
rats.
An
equal
number
of
animals
were
treated
with
heat­
killed
test
substance
(KTS)
and
four
animals/
sex
served
as
untreated
controls.
Animals
were
observed
for
up
to
14
days
with
interim
scheduled
sacrifices.
A
total
of
15
rats
(3/
8
male
and
2/
8
female
TS­
dosed
rats
and
6/
8
male
and
4/
8
female
KTS­
dosed
rats)
died
on
days
2
and
3.
Laboured
respiration,
rough
hair
coat,
ocular
discharge
and
nasal
discharge
were
observed
in
both
TS­
and
KTS­
dosed
rats.
Hunched
posture
and
lethargy
were
also
observed
in
one
female
and
one
male
TS­
dosed
rat,
respectively.
The
presence
or
absence
of
clinical
symptoms
were
not
indicative
of
spontaneous
deaths.
Due
to
the
large
number
of
spontaneous
deaths
and
a
number
of
missed
data
collections,
data
for
evaluating
effects
on
body
weights,
food
consumption
and
relative
organ
weight
were
limited.
At
the
end
of
the
14–
day
long
study,
administration
of
P.
flocculosa
did
not
have
a
statistically
significant
effect
on
body
weight.
Analyses
of
daily
food
consumption
and
relative
organ
weights
were
skewed
as
they
were
either
not
determined
or
did
not
include
animals
that
died
prior
to
their
scheduled
sacrifice
dates.
At
necropsy,
liver
lesions
and
lesions
and
enlargement
of
the
lung
and
spleen
were
observed
in
both
TS­
and
KTSdosed
rats.
Confluent
dark
areas
were
also
seen
in
the
kidneys
of
a
single
male
TS­
dosed
rat.
These
necropsy
findings
were
considered
consistent
with
the
VerDate
Sep<
04>
2002
16:
57
Sep
26,
2002
Jkt
197001
PO
00000
Frm
00109
Fmt
4700
Sfmt
4700
E:\
FR\
FM\
27SER1.
SGM
27SER1
60962
Federal
Register
/
Vol.
67,
No.
188
/
Friday,
September
27,
2002
/
Rules
and
Regulations
method
of
dosing
and
the
body's
normal
immunological
response
to
a
foreign
substance.
Pseudozyma
flocculosa
was
detected
in
the
lungs
and
lymph
nodes
and
the
stomach
and
small
intestine
of
TS­
dosed
animals
only.
Counts
in
these
tissues
were
below
the
limit
of
detection
by
day
7.
Based
on
this
study,
P.
flocculosa
is
toxic,
but
not
infective
or
pathogenic,
at
the
dose
administered
when
introduced
by
the
intratracheal
route
to
male
and
female
CD
rats.
This
acute
pulmonary
study,
however,
was
originally
classified
as
unacceptable
due
to
major
deficiencies
in
the
collected
data
and
a
possible
dosing
error,
as
indicated
by
the
presence
of
the
microbial
pest
control
agent
(MPCA)
in
the
stomach
and
small
intestines
on
the
day
of
dosing.
However,
there
was
relevant
pathogenicity
information
that
indicated
clearance
of
the
MPCA.
Thus,
this
study
is
considered
to
be
supplemental
because
it
provides
acceptable
information
regarding
infectivity/
pathogenicity;
however,
this
study
does
not
differentiate
the
cause
of
certain
mortalities
in
the
TS
and
KTS
treatments.
A
confirmatory
acute
pulmonary
toxicity/
pathogenicity
study
using
the
technical
grade
of
the
active
ingredient
(TGAI)
and
testing
of
the
sterile
filtrate
from
the
production
culture
will
therefore
be
required
to
provide
this
additional
information
as
a
condition
of
registration.
3.
Acute
pulmonary
range­
finding
study
(OPPTS
885.3150)
(MRID
numbers
451152–
07
and
453634–
01).
In
order
to
determine
whether
the
test
substance
(in
both
its
viable
and
non­
viable
forms),
P.
flocculosa,
was
the
cause
of
the
deaths,
a
subsequent
acute
pulmonary
rangefinding
toxicity
study
was
conducted.
In
this
range­
finding
study,
groups
of
young
adult
CD
rats
(5/
sex/
dose
level)
were
exposed
by
the
intratracheal
route
to
P.
flocculosa
(4.2
x
10
7
CFU/
mL)
in
ASTM
Type
1
water
at
doses
of
4.2
x
10
7
,
3.4
x
10
7
,
6.8
x
10
6
and
3.4
x
10
6
CFU/
animal.
Animals
were
then
observed
for
14
days.
There
were
no
mortalities
and
all
animals
gained
weight
during
the
study.
Rough
hair
coat
occurred
in
a
dose­
dependent
manner
with
all
5
animals/
sex
exhibiting
this
symptom
at
the
highest
dose
of
4.2
x
10
7
CFU/
animal.
One
female
dosed
with
4.2
x
10
7
CFU
experienced
tremors,
closed
eyes
and
rough
hair
coat.
Pseudozyma
flocculosa
was
classified
as
being
of
slight
toxicity
(EPA
Toxicity
Category
IV)
based
on
adverse
effects
observed
in
some
test
animals.
This
acute
pulmonary
study
was
considered
supplemental.
According
to
USEPA
OPPTS
885.3150,
the
minimum
dose
is
10
8
units
of
the
MPCA
per
test
animal.
The
maximum
dose
level
used
in
this
study,
however,
was
only
4.2
x
10
7
CFU/
animal.
Furthermore,
infectivity
was
not
addressed;
however,
the
acute
pulmonary
toxicity/
pathogenicity
study
did
address
infectivity
sufficiently.
Consequently,
this
study
does
not
satisfy
the
guideline
requirement
for
an
acute
pulmonary
study
(OPPTS
885.3150)
in
the
rat.
EPA,
in
considering
the
two
studies
together,
believes
that
there
are
sufficient
data
with
which
to
determine
the
toxicity
and
pathogenicity
of
Pseudozyma
flocculosa.
As
any
potential
inhalation
risk
that
is
raised
by
these
studies
is
primarily
a
worker
risk,
EPA
is
requiring
that
a
respirator
be
worn
by
workers
to
limit
any
inhalation
exposures.
In
addition,
a
RestrictedEntry
Interval
(REI)
of
4
hours
is
required
for
early
entry
postapplication
workers
or
other
persons
entering
treated
greenhouses.
Finally,
a
confirmatory
acute
pulmonary
toxicity/
pathogenicity
study
using
the
TGAI
and
testing
of
the
sterile
filtrate
from
the
production
culture
will
be
required
as
a
condition
of
registration.
4.
Intraperitoneal
toxicity/
infectivity
study
(OPPTS
885.3200)
(MRID
numbers
451152–
08
and
453634–
01).
In
an
acute
intraperitoneal
toxicity/
infectivity
study,
groups
of
young
adult
CD
rats
(4/
sex/
scheduled
sacrifice
date)
were
exposed
by
the
intraperitoneal
route
to
an
undiluted
suspension
of
P.
flocculosa
(TS)
at
a
dose
of
3.5
x
10
7
CFU/
animal
(in
1.0
mL).
Animals
were
then
observed
for
up
to
14
days.
An
equal
number
of
young
adult
CD
rats
were
similarly
injected
with
heat­
killed
test
substance
(KTS).
An
undosed
naive
control
(NC)
group
consisting
of
4
rats/
sex
was
also
included
in
the
study.
Cage
side
observation
for
clinical
symptoms
was
performed
daily
and
animal
body
weights
and
food
consumption
were
monitored.
No
unscheduled
deaths
occurred.
Designated
animals
from
the
TS
and
KTS
groups
were
sacrificed
on
days
0,
7,
and
14
and
gross
necropsies
were
performed.
The
NC
group
of
animals
was
sacrificed
and
necropsied
at
the
end
of
the
14–
day
study.
Infectivity
and
clearance
were
assessed
by
quantitatively
recovering
the
MPCA
from
the
blood,
lungs
and
lymph
nodes,
spleen,
kidneys,
liver,
heart,
stomach
and
small
intestine,
peritoneal
fluid,
caecum
and
brain.
No
adverse
clinical
signs
were
observed
at
any
point
of
the
study
in
any
of
the
groups
of
rats.
Body
weight
gain
of
TS­
dosed
male
rats
was
significantly
decreased
while
this
group's
food
consumption
was
significantly
increased
compared
to
NC
animals.
There
was
no
significant
difference
between
KTS­
dosed
and
NC
animals
in
terms
of
body
weight,
body
weight
gain
or
food
consumption.
Upon
necropsy
of
TS­
and
KTS­
dosed
animals,
white
nodules
and
higher
relative
spleen
weights
were
observed
and
attributed
to
a
normal
immune
response
to
a
foreign
substance.
The
detection
of
P.
flocculosa
in
the
peritoneal
fluid
lavage
of
TS­
dosed
male
rats
was
consistent
with
the
method
of
administration.
Clearance
of
P.
flocculosa
from
all
other
tissues
and
fluids
occurred
by
day
7.
No
test
substance
was
detected
from
any
of
the
organs
of
the
KTS­
dosed
or
NC
animals.
At
the
dose
administered,
P.
flocculosa
was
slightly
toxic
but
not
pathogenic
to
male
and
female
CD
rats
when
introduced
by
the
intraperitoneal
route.
5.
Acute
dermal
toxicity/
irritation
study
(OPPTS
885.3100)
(MRID
numbers
451152–
09
and
453634–
01).
In
an
acute
dermal
toxicity
study,
a
single
group
of
New
Zealand
White
rabbits
(5/
sex)
was
dermally
exposed
to
1.2
x
10
7
CFU
P.
flocculosa
(equivalent
to
approximately
0.82­
0.90
g/
kg
bw
for
males
and
0.80­
0.91
g/
kg
bw
for
females),
for
24
hours
to
an
area
equivalent
to
approximately
10%
of
the
dorsal
skin
surface.
Following
exposure,
the
animals
were
observed
for
a
period
of
14
days.
No
treatment­
related
signs
of
toxicity
or
skin
irritation
were
observed
in
any
animal
during
the
14–
day
observation
period.
At
the
dose
administered,
P.
flocculosa
was
not
considered
toxic
or
irritating
to
the
skin.
6.
Primary
eye
irritation
study
(OPPTS
870.2400)
(MRID
numbers
451152–
10
and
453634–
01).
Administration
of
0.1
g
of
Sporodex
WP
to
the
eyes
of
rabbits
resulted
in
slight
conjunctival
redness
in
5/
6
animals
at
the
1–
hour
scoring
interval
and
in
2/
6
rabbits
at
the
24–
hour
scoring
interval.
By
the
48–
hour
scoring
interval,
all
signs
of
ocular
irritation
had
subsided.
There
were
no
other
adverse
clinical
symptoms
or
mortalities
during
the
7–
day
observation
period.
The
maximum
irritation
score
(MIS)
was
1.7
at
the
1–
hour
scoring
interval
and
the
maximum
average
score
(MAS)
was
0.22
over
the
24–,
48–
and
72–
hour
scoring
intervals.
Based
on
the
MAS,
Sporodex
WP
was
classified
as
minimally
irritating.
7.
Subchronic,
chronic
toxicity
and
oncogenicity.
Survival,
replication,
infectivity,
significant
toxicity
or
persistence
of
the
MPCA
was
not
observed
in
the
test
animals
treated
in
Tier
I
acute
oral,
pulmonary
and
intravenous
toxicity/
infectivity
tests.

VerDate
Sep<
04>
2002
16:
57
Sep
26,
2002
Jkt
197001
PO
00000
Frm
00110
Fmt
4700
Sfmt
4700
E:\
FR\
FM\
27SER1.
SGM
27SER1
60963
Federal
Register
/
Vol.
67,
No.
188
/
Friday,
September
27,
2002
/
Rules
and
Regulations
Consequently,
higher
tier
tests
involving
subchronic
and
chronic
testing,
oncogenicity
testing,
mutagenicity
and
teratogenicity
were
not
required
based
on
the
lack
of
concerns
following
analysis
of
Tier
I
test
results.
However,
a
genotoxicity
computer
search
for
Pseudozyma
flocculosa
was
conducted.
No
reports
of
mammalian
toxicity
were
found
in
standard
biological,
chemical
and
toxicological
abstracts.
The
applicant
included
computer
literature
search
results
to
a
number
of
keywords
such
as
pseudozyma;
tilletiopsis,
fate,
non
target,
carcin,
mutagen;
toxic,
pathogen,
antibiotic,
polyen;
sporothrix,
sporobolomyces,
rhodotorula,
phyllosphere
yeast;
carcinog
and
teratogen.
The
literature
search
covered
AGRICOLA,
Biological
Abstracts,
CAB
Abstracts,
CHEMTOX,
RTEX
and
AGRIS
databases
from
1980
to
1999.
8.
Hypersensitivity
(dermal
sensitization)
study
(OPPTS
870.2600).
The
applicant
has
also
submitted
an
acceptable
waiver
rationale
from
conducting
a
dermal
sensitization
study
based
on
the
assumption
that
most
microorganisms
contain
substances
that
could
elicit
a
hypersensitivity
response.
Pseudozyma
flocculosa
is
considered
a
potential
sensitizing
agent,
therefore,
the
statement,
``
POTENTIAL
SENSITIZER''
is
required
on
the
principal
display
panels
of
the
technical
and
end­
use
formulation
labels.
The
use
of
personal
protective
equipment
will
also
be
required
to
mitigate
against
potential
dermal
sensitization
in
occupationally
exposed
workers/
handlers.
9.
Reports
of
hypersensitivity
incidents
(OPPTS
885.3400).
Skin
sensitizing
studies
are
not
considered
substitutes
for
timely
reports
of
hypersensitivity
incidents
subsequent
to
registration
approval.
No
adverse
effects
have
been
noted
among
researchers
who
have
worked
closely
with
P.
flocculosa
strain
PF­
A22
UL
for
up
to
10
years.
The
applicant
will
be
expected
to
report
any
subsequent
findings
of
hypersensitivity
or
other
health
incidents
to
workers,
applicators,
or
bystanders
exposed
to
the
MPCA
as
a
condition
of
registration.
Incident
reports
are
to
include
details
such
as
a
description
of
the
MPCA
and
formulation,
frequency,
duration
and
routes
of
exposure
to
the
material,
clinical
observations,
and
any
other
relevant
information.
10.
Effects
on
the
immune
systems
(OPPTS
880.3800,
immune
response).
The
active
ingredient,
P.
flocculosa
strain
PF­
A22
UL,
is
not
known
to
be
a
human
pathogen
nor
an
endocrine
disrupter.
The
submitted
toxicity/
pathogenicity
studies
in
the
rodent
indicate
that,
following
several
routes
of
exposure,
the
immune
system
is
still
intact
and
able
to
process
and
clear
the
active
ingredient.
Therefore,
no
adverse
effects
to
the
immune
systems
are
known
or
expected.
Based
on
this
rationale,
the
registrant
waiver
request
for
OPPTS
880.3800
(Immune
Response)
was
found
to
be
acceptable.

V.
Aggregate
Exposures
A.
Dietary
Exposure
In
examining
aggregate
exposure,
FFDCA
section
408
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
buildings
(residential
and
other
indoor
uses).
1.
Food.
The
proposed
food
use
pattern
is
likely
to
result
in
residues
in
or
on
food
and
feed.
Residues
of
the
microbial
pesticide
are
likely
to
be
removed
from
treated
food
by
washing,
peeling,
cooking
and
processing.
Even
if
residues
are
not
removed,
however,
EPA
believes
that
dietary
exposure
to
the
microbial
agent
will
result
in
negligible
to
no
risk
to
consumers.
Although
Pseudozyma
species
are
ubiquitous
in
nature
and
have
been
isolated
from
a
wide
variety
of
plant
surfaces
including
leaf
litter,
clover,
maize
and
cucumber,
no
adverse
effects
from
dietary
exposure
have
been
attributed
to
natural
populations
of
Pseudozyma
flocculosa.
Furthermore,
no
adverse
effects
were
observed
at
maximum
hazard
dose
levels
in
the
acute
oral
toxicity/
pathogenicity
study
and
there
are
no
reports
of
known
mammalian
toxins
being
produced
by
the
MPCA.
Subchronic
and
chronic
dietary
exposure
studies
were
not
required
because
the
Tier
I
acute
oral
study
demonstrated
a
low
level
of
toxicity
and
no
pathogenicity
potential
for
the
active
microorganism.
Because
of
the
low
toxicity
profile
and
low
potential
exposure
of
the
MPCA
expected
for
the
proposed
uses,
there
is
no
concern
for
chronic
risks
posed
by
dietary
exposure
for
the
general
population
or
sensitive
subpopulations,
such
as
infants
and
children.
In
addition,
an
extensive
literature
search
yielded
no
reports
of
mammalian
toxins
being
produced
by
P.
flocculosa.
The
fungitoxic
unsaturated
C­
17
fatty
acids
and
acyclic
norterpene
produced
by
the
MPCA
have
not
been
reported
to
be
toxic
to
mammals.
Neither
this
organism
nor
its
close
relatives
are
listed
among
microbial
contaminants
of
food.
Therefore,
EPA
expects
negligible
to
no
dietary
risk
from
exposure
to
naturally­
occurring
and
isolated
P.
flocculosa
strain
PF­
A22
UL
residues.
2.
Drinking
water
exposure.
Although
heavy
rainfall
likely
carries
P.
flocculosa
into
neighboring
aquatic
environments,
growth
and
survival
of
terrestrial
fungi
such
as
P.
flocculosa
is
limited
in
such
environments.
Thus,
it
is
not
expected
to
proliferate
in
aquatic
habitats
following
incidents
of
direct
or
indirect
exposure
(e.
g.,
runoff
from
treated
greenhouses).
Moreover,
P.
flocculosa
is
not
considered
to
pose
a
risk
to
humans
from
exposure
to
drinking
water
because
of
minimal
to
non­
existent
toxicity.
Accordingly,
drinking
water
is
not
specifically
screened
for
P.
flocculosa
as
a
potential
indicator
of
microbial
contamination
or
as
a
direct
pathogenic
contaminant.
Both
percolation
through
soil
and
municipal
treatment
of
drinking
water
would
reduce
the
possibility
of
significant
transfer
of
residues
to
drinking
water.
Therefore,
the
potential
of
exposure
and
risk
via
drinking
water
is
likely
to
be
minimal
to
non­
existent
for
this
MPCA.

B.
Other
Non­
Occupational
Exposure
The
current
label
does
not
allow
applications
to
turf,
residential
or
recreational
areas.
Because
the
use
sites
are
in
greenhouses,
exposure
to
the
U.
S.
population
including
infants
and
children
in
school,
residential
and
daycare
facilities
is
likely
to
be
minimal
to
non­
existent.
Consequently,
the
health
risk
posed
by
P.
flocculosa
strain
PF
A­
22
UL
from
non­
occupational
dermal
and
inhalation
exposures
to
the
general
public,
including
infants
and
children,
is
expected
to
be
negligible
to
non­
existent.
Any
concerns
for
potential
inhalation
risk
is
for
occupational
exposures,
and
as
mentioned
previously,
will
be
mitigated
by
the
requirement
of
a
respirator
and
restriction
of
the
reentry
interval.

VI.
Cumulative
Effects
The
Agency
has
considered
available
information
on
the
cumulative
effects
of
such
residues
and
other
substances
that
have
a
common
mechanism
of
toxicity.
These
considerations
included
the
cumulative
effects
on
infants
and
children
of
such
residues
and
other
substances
with
a
common
mechanism
of
toxicity.
EPA
is
not
aware
of
any
other
bacteria
or
other
substances,
besides
naturally­
occurring
strains
of
Pseudozyma,
that
share
a
common
mechanism
of
toxicity
with
this
active
ingredient.
Given
the
low
toxicity
and
pathogenicity
profile
of
P.
flocculosa,
even
if
there
were
any
other
substances
with
which
P.
flocculosa
shared
a
VerDate
Sep<
04>
2002
16:
57
Sep
26,
2002
Jkt
197001
PO
00000
Frm
00111
Fmt
4700
Sfmt
4700
E:\
FR\
FM\
27SER1.
SGM
27SER1
60964
Federal
Register
/
Vol.
67,
No.
188
/
Friday,
September
27,
2002
/
Rules
and
Regulations
common
mechanism
of
toxicity,
no
adverse
cumulative
effects
are
expected.

VII.
Determination
of
Safety
for
U.
S.
Population,
Infants
and
Children
Based
on
the
toxicology
data
submitted
and
other
relevant
information
in
the
Agency's
files,
there
is
reasonable
certainty
no
harm
will
result
from
aggregate
exposure
of
residues
of
Pseudozyma
flocculosa
strain
PF­
A22
UL
to
the
U.
S.
population,
including
infants
and
children,
under
reasonably
foreseeable
circumstances
when
the
microbial
pesticide
product
is
used
as
labeled.
This
includes
all
anticipated
dietary
exposures
and
all
other
exposures
for
which
there
is
reliable
information.
The
Agency
has
arrived
at
this
conclusion
based
on
data
submitted
demonstrating
low
toxicity
at
the
maximum
doses
tested
and
a
lack
of
information
showing
adverse
effects
from
exposure
to
naturally
occurring
P.
flocculosa
as
well
as
a
consideration
of
the
product
as
currently
registered
and
labeled.
As
a
result,
EPA
establishes
an
exemption
from
tolerance
requirements
pursuant
to
FFDCA
408(
c)
and
(d)
for
residues
of
Pseudozyma
flocculosa
strain
PF­
A22
UL
in
or
on
all
food
commodities.
FFDCA
section
408
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
unless
EPA
determines
that
a
different
margin
of
exposure
(safety)
will
be
safe
for
infants
and
children.
Margins
of
exposure
(safety)
are
often
referred
to
as
uncertainty
(safety)
factors.
In
this
instance,
based
on
all
the
available
information,
the
Agency
concludes
that
P.
flocculosa
strain
PFA22
UL
is
practically
non­
toxic
to
mammals,
including
infants
and
children.
Thus,
there
are
no
threshold
effects
of
concern
and,
as
a
result
the
provision
requiring
an
additional
margin
of
safety
does
not
apply.
Further,
the
provisions
of
consumption
patterns,
special
susceptibility,
and
cumulative
effects
do
not
apply.
As
a
result,
EPA
has
not
used
a
margin
of
exposure
(safety)
approach
to
assess
the
safety
of
P.
flocculosa
strain
PF­
A22
UL.

VIII.
Other
Considerations
A.
Endocrine
Disruptors
EPA
does
not
have
any
information
regarding
endocrine
effects
of
this
microbial
pesticide
at
this
time.
There
is
no
evidence
to
suggest
that
use
of
P.
flocculosa
strain
PF­
A22
UL
at
the
proposed
concentrations
will
adversely
affect
the
endocrine
system.
The
active
ingredient,
P.
flocculosa
strain
PF­
A22
UL,
is
not
known
to
be
a
human
pathogen
nor
an
endocrine
disrupter.
The
submitted
toxicity/
pathogenicity
studies
in
the
rodent
indicate
that,
following
several
routes
of
exposure,
the
immune
system
is
still
intact
and
able
to
process
and
clear
the
active
ingredient.
Therefore,
no
adverse
effects
to
the
endocrine
systems
are
known
or
expected.

B.
Analytical
Method(
s)
As
part
of
the
standard
Quality
Control
measures,
the
Agency
is
requiring
microbial
assays
and
analytical
methods
to
identify
the
active
ingredient
and
potential
contaminants.
Analytical
methods
are
available
and
sufficient
to
identify
metabolites
and
contaminants
within
regulatory
levels.
All
batches
containing
potential
human
pathogens
are
to
be
destroyed.
The
MPCA
is
identified
using
a
combination
of
morphological
traits,
molecular
techniques
and
biological
activity.
The
identification
of
Pseudozyma
to
the
species
level
is
done
using
a
standard
mycological
approach.
Pseudozyma
species
can
be
differentiated
from
morphologically
similar
species
such
as
Hyalodendron,
Tilletiopsis,
Sporobolomyces
and
Sporothrix.
The
branching
conidiophores
of
Pseudozyma
can
be
confused
with
those
produced
by
Hyalodendron;
however,
the
whole
cell
hydrolysates
of
this
filamentous
basidiomycete
contain
xylose
which
is
not
found
in
Pseudozyma.
Tilletiopsis
and
Sporobolomyces,
other
saprophytic
wild
yeasts
on
aerial
plant
surfaces,
are
different
from
Pseudozyma
in
that
they
produce
spores
that
are
forcibly
discharged
upon
sporulation
(ballistospores).
Furthermore,
Tilletiopsis
species
produce
a
fungusdegrading
b
­1,3
glucanase
that
is
not
produced
by
Pseudozyma
species.
The
genus
Sporothrix
represents
a
group
of
anamorphic
ascomycetous
yeasts
such
as
Sporothrix
schenckii
(type),
an
animal
pathogen.
Physiologically,
Pseudozyma
species
differ
greatly
from
Sporothrix
species.
Unlike
the
ascomycetous
Sporothrix
anamorphs,
P.
flocculosa
shows
positive
reactions
in
Diazonium
Blue
B
and
urease
tests
typical
of
all
basidiomycetous
yeasts.
Also,
the
major
ubiquinone
is
Q­
10
rather
than
Q­
8
or
Q­
9
typical
of
the
ascomycetes,
Saccharomycopsis
and
Stephanoascus.
Strain
PF­
A22
UL
can
be
differentiated
from
other
strains
of
P.
flocculosa
using
a
DNA­
based
technique
called
multiplex
polymerase
chain
reaction
(multiplex
PCR).
The
multiplex
PCR
system
is
essentially
a
cocktail
of
different
primers
which
allows
the
rapid
assessment
of
numerous
DNA
fragments
in
a
single
PCR
amplification.
The
protocol
is
based
on
the
amplification
of
two
nuclear
regions,
(ITS
and
NS),
and
one
mitochondrial
region
(ML).
Those
regions
were
found
to
be
discriminant
in
the
identification
of
P.
flocculosa
PFA22
UL.
The
integrity
and
consistency
of
the
MPCA
is
ensured
by
two
methods.
The
first
method
is
a
DNA­
based
PCR
technique
called
random
amplified
microsatellites
PCR
(RAMS).
Microsatellites
are
hypervariable
noncoding
regions
of
DNA
within
the
genome
that
evolve
more
rapidly
than
coding
DNA.
The
other
method
is
a
bioassay
that
measures
biological
activity.
The
biological
activity
of
the
MPCA
is
measured
by
the
inhibition
zone
created
when
a
susceptible
organism
is
grown
next
to
it.
Given
that
the
pest
controlled,
Sphaerotheca
species,
is
an
obligate
biotroph,
it
cannot
be
used
directly
in
this
bioassay.
Instead,
a
Phomopsis
species
is
used
because
its
sensitivity
to
P.
flocculosa's
fungitoxic
secretions
is
similar.

C.
Codex
Maximum
Residue
Level
There
are
no
Codex
Maximum
Residue
Levels
or
exemption
from
tolerances
for
the
microbial
active
ingredient
Pseudozyma
flocculosa
strain
PF­
A22
UL.

IX.
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
of
1996,
EPA
will
continue
to
use
those
procedures,
with
appropriate
adjustments,
until
the
necessary
modifications
can
be
made.
The
new
section
408(
g)
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
FFDCA
sections
408
and
409.
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
VerDate
Sep<
04>
2002
16:
57
Sep
26,
2002
Jkt
197001
PO
00000
Frm
00112
Fmt
4700
Sfmt
4700
E:\
FR\
FM\
27SER1.
SGM
27SER1
60965
Federal
Register
/
Vol.
67,
No.
188
/
Friday,
September
27,
2002
/
Rules
and
Regulations
178.
To
ensure
proper
receipt
by
EPA,
you
must
identify
docket
ID
number
OPP–
2002–
0233
in
the
subject
line
on
the
first
page
of
your
submission.
All
requests
must
be
in
writing,
and
must
be
mailed
or
delivered
to
the
Hearing
Clerk
on
or
before
November
26,
2002.
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.
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.
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.
3.
Copies
for
the
Docket.
In
addition
to
filing
an
objection
or
hearing
request
with
the
Hearing
Clerk
as
described
in
Unit
IX.
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.
2.
Mail
your
copies,
identified
by
docket
ID
number
OPP–
2002–
0233,
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.
In
person
or
by
courier,
bring
a
copy
to
the
location
of
the
PIRIB
described
in
Unit
I.
B.
2.
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).

X.
Regulatory
Assessment
Requirements
This
final
rule
establishes
an
exemption
from
the
tolerance
requirement
under
FFDCA
section
408(
d)
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
FFDCA
section
408(
d),
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
VerDate
Sep<
04>
2002
16:
57
Sep
26,
2002
Jkt
197001
PO
00000
Frm
00113
Fmt
4700
Sfmt
4700
E:\
FR\
FM\
27SER1.
SGM
27SER1
60966
Federal
Register
/
Vol.
67,
No.
188
/
Friday,
September
27,
2002
/
Rules
and
Regulations
retailers,
not
States.
This
action
does
not
alter
the
relationships
or
distribution
of
power
and
responsibilities
established
by
Congress
in
the
preemption
provisions
of
FFDCA
section
408(
n)(
4).
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.

XI.
Submission
to
Congress
and
the
Comptroller
General
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:
September
19,
2002.
James
Jones,
Acting
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
374.

2.
Section
180.1221
is
added
to
subpart
D
to
read
as
follows:

§
180.1221
Pseudozyma
flocculosa
strain
PF­
A22
UL;
exemption
from
the
requirement
of
a
tolerance.

An
exemption
from
the
requirement
of
a
tolerance
is
established
for
residues
of
Pseudozyma
flocculosa
strain
PF­
A22
UL
in
or
on
all
food
commodities.

[FR
Doc.
02–
24651
Filed
9–
26–
02;
8:
45
am]

BILLING
CODE
6560–
50–
S
ENVIRONMENTAL
PROTECTION
AGENCY
40
CFR
Part
180
[OPP–
2002–
0229;
FRL–
7196–
8]

Fenamidone;
Pesticide
Tolerance
AGENCY:
Environmental
Protection
Agency
(EPA).

ACTION:
Final
rule.

SUMMARY:
This
regulation
establishes
tolerances
for
residues
of
fenamidone,
[4H­
Imidazol­
4­
one,
3,5­
dihydro­
5­
methyl­
2­(
methylthio)­
5­
phenyl­
3­
(phenylamino)­,
(S)­],
in
or
on
lettuce,
head
at
15
ppm
and
lettuce,
leaf
at
20
ppm.
Aventis
CropScience
requested
these
tolerances
under
the
Federal
Food,
Drug,
and
Cosmetic
Act,
as
amended
by
the
Food
Quality
Protection
Act
of
1996.
Subsequent
to
the
filing
of
this
petition,
Bayer
Corporation
acquired
Aventis
CropScience
to
form
Bayer
CropScience.
Therefore,
the
registrant
is
now
Bayer
CropScience.

DATES:
This
regulation
is
effective
September
27,
2002.
Objections
and
requests
for
hearings,
identified
by
docket
control
number
OPP–
2002–
0229,
must
be
received
on
or
before
November
26,
2002.

ADDRESSES:
Written
objections
and
hearing
requests
may
be
submitted
by
mail,
in
person,
or
by
courier.
Please
follow
the
detailed
instructions
for
each
method
as
provided
in
Unit
VI.
of
the
SUPPLEMENTARY
INFORMATION.
To
ensure
proper
receipt
by
EPA,
your
objections
and
hearing
requests
must
identify
docket
control
number
OPP–
2002–
0229
in
the
subject
line
on
the
first
page
of
your
response.
FOR
FURTHER
INFORMATION
CONTACT:
By
mail:
Cynthia
Giles­
Parker,
Registration
Division
(7505C),
Office
of
Pesticide
Programs,
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460;
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
affected
by
this
action
if
you
are
an
agricultural
producer,
food
manufacturer,
or
pesticide
manufacturer.
Potentially
affected
categories
and
entities
may
include,
but
are
not
limited
to:

Categories
NAICS
codes
Examples
of
potentially
affected
entities
Industry
111
112
311
32532
Crop
production
Animal
production
Food
manufacturing
Pesticide
manufacturing
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
the
table
could
also
be
affected.
The
North
American
Industrial
Classification
System
(NAICS)
codes
have
been
provided
to
assist
you
and
others
in
determining
whether
or
not
this
action
might
apply
to
certain
entities.
If
you
have
questions
regarding
the
applicability
of
this
action
to
a
particular
entity,
consult
the
person
listed
under
FOR
FURTHER
INFORMATION
CONTACT.

B.
How
Can
I
Get
Additional
Information,
Including
Copies
of
this
Document
and
Other
Related
Documents?

1.
Electronically.
You
may
obtain
electronic
copies
of
this
document,
and
certain
other
related
documents
that
might
be
available
electronically,
from
the
EPA
Internet
Home
Page
at
http://
www.
epa.
gov/.
To
access
this
document,
on
the
Home
Page
select
``
Laws
and
Regulations,
''
``
Regulations
and
Proposed
Rules,
''
and
then
look
up
the
entry
for
this
document
under
the
``
Federal
Register—
Environmental
Documents.
''
You
can
also
go
directly
to
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
VerDate
Sep<
04>
2002
16:
57
Sep
26,
2002
Jkt
197001
PO
00000
Frm
00114
Fmt
4700
Sfmt
4700
E:\
FR\
FM\
27SER1.
SGM
27SER1