Document ID: EPA-HQ-OPP-2003-0077-0001
Agency: epa
Document Type: Rule
Title: Meferpyr-Diethyl; Pesticide Tolerance
Posted Date: 2003-04-30T04:00Z

23038
Federal
Register
/
Vol.
68,
No.
83
/
Wednesday,
April
30,
2003
/
Rules
and
Regulations
Dated:
April
11,
2003.
Alexis
Strauss,
Acting
Regional
Administrator,
Region
IX.


Part
52,
chapter
I,
title
40
of
the
Code
of
Federal
Regulations
is
amended
as
follows

PART
52
 
[
AMENDED]


1.
The
authority
citation
for
part
52
continues
to
read
as
follows:

Authority:
42
U.
S.
C.
7401
et
seq.

Subpart
F
 
California

2.
Section
52.220
is
amended
by
adding
paragraphs
(
c)(
21)(
vi)(
D),
(
c)(
41)(
ii)(
F),
(
c)(
103)(
ii)(
E),
(
c)(
176)(
i)(
B)(
2),
(
c)(
182)(
i)(
E)(
2),
(
c)(
307)(
i)(
C),
and
(
c)(
308)(
i)(
B)
to
read
as
follows:

§
52.220
Identification
of
plan.

*
*
*
*
*
(
c)
*
*
*
(
21)
*
*
*
(
vi)
*
*
*
(
D)
Previously
approved
on
May
11,
1977
in
paragraph
(
c)(
21)(
vi)(
A)
of
this
section
and
now
deleted
Rules
105,
106,
107,
110,
111,
and
112
(
now
replaced
by
Rule
101).
*
*
*
*
*
(
41)
*
*
*
(
ii)
*
*
*
(
F)
Previously
approved
on
August
31,
1978
in
paragraph
(
c)(
41)(
ii)(
A)
of
this
section
and
now
deleted
Rule
104
(
now
replaced
by
Rule
101).
*
*
*
*
*
(
103)
*
*
*
(
ii)
*
*
*
(
E)
Previously
approved
on
July
6,
1982
in
paragraph
(
c)(
103)(
ii)(
B)
of
this
section
and
now
deleted
Rule
109
(
now
replaced
by
Rule
101).
*
*
*
*
*
(
176)
*
*
*
(
i)
*
*
*
(
B)
*
*
*
(
2)
Previously
approved
on
October
23,
1989
in
paragraph
(
c)(
176)(
i)(
B)(
1)
of
this
section
and
now
deleted
Section
442
(
now
replaced
by
Section
436).
*
*
*
*
*
(
182)
*
*
*
(
i)
*
*
*
(
E)
*
*
*
(
2)
Previously
approved
on
March
11,
1988
in
paragraph
(
c)(
182)(
i)(
E)(
1)
of
this
section
and
now
deleted
Rules
101,
102,
103,
and
108
(
now
replaced
by
Rule
101).
*
*
*
*
*
(
307)
*
*
*
(
i)
*
*
*
(
C)
San
Diego
County
Air
Pollution
Control
District.
(
1)
Rule
101,
adopted
on
September
25,
2002.
*
*
*
*
*
(
308)
*
*
*
(
i)
*
*
*
(
B)
Lake
County
Air
Quality
Management
District.
(
1)
Sections
226.5,
232.1,
238.5,
249.3,
250.5,
433.5,
436,
and
436.5,
adopted
on
October
1,
2002
and
Sections
431.5,
431.7,
432.5,
and
433,
amended
on
October
1,
2002.
*
*
*
*
*
[
FR
Doc.
03
 
10426
Filed
4
 
29
 
03;
8:
45
am]

BILLING
CODE
6560
 
50
 
U
ENVIRONMENTAL
PROTECTION
AGENCY
40
CFR
Part
180
[
OPP
 
2003
 
0077;
FRL
 
7297
 
9]

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

SUMMARY:
This
regulation
establishes
tolerances
for
the
combined
residues
of
mefenpyr­
diethyl
also
known
chemically
as
1­(
2,4­
dichlorophenyl)­
4,5­
dihydro­
5­
methyl­
1H­
pyrazole­
3,5­
dicarboxylic
acid,
diethyl
ester
in
or
on
wheat
and
barley
commodities.
Bayer
CropScience
formerly
doing
business
as
Aventis
CropScience
and/
or
AgrEvo
Company
requested
this
tolerance
under
the
Federal
Food,
Drug,
and
Cosmetic
Act
(
FFDCA),
as
amended
by
the
Food
Quality
Protection
Act
of
1996
(
FQPA).
DATES:
This
regulation
is
effective
April
30,
2003.
Objections
and
requests
for
hearings,
identified
by
docket
ID
number
OPP
 
2003
 
0077,
must
be
received
on
or
before
June
30,
2003.
ADDRESSES:
Written
objections
and
hearing
requests
may
be
submitted
electronically,
by
mail,
or
through
hand
delivery/
courier.
Follow
the
detailed
instructions
as
provided
in
Unit
VI.
of
the
SUPPLEMENTARY
INFORMATION.

FOR
FURTHER
INFORMATION
CONTACT:
Bipin
Gandhi,
Registration
Division
(
7505C),
Office
of
Pesticide
Programs,
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460
 
0001;
telephone
number:
(
703)
308
 
8380;
e­
mail
address:
gandhi.
bipin@
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:
 
Industry
(
NAICS
111),
e.
g.,
crop
production
 
Industry
(
NAICS
112),
e.
g.,
animal
production
 
Industry
(
NAICS
311),
e.
g.,
food
manufacturing
 
Industry
(
NAICS
32532),
e.
g.,
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
this
unit
could
also
be
affected.
The
North
American
Industrial
Classification
System
(
NAICS)
codes
have
been
provided
to
assist
you
and
others
in
determining
whether
this
action
might
apply
to
certain
entities.
If
you
have
any
questions
regarding
the
applicability
of
this
action
to
a
particular
entity,
consult
the
person
listed
under
FOR
FURTHER
INFORMATION
CONTACT.

B.
How
Can
I
Get
Copies
of
this
Document
and
Other
Related
Information?
1.
Docket.
EPA
has
established
an
official
public
docket
for
this
action
under
docket
identification
(
ID)
number
OPP
 
2003
 
0077.
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.

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Federal
Register
/
Vol.
68,
No.
83
/
Wednesday,
April
30,
2003
/
Rules
and
Regulations
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
September
26,
1997
(
62
FR
50610)
(
FRL
 
5740
 
2),
EPA
issued
a
notice
pursuant
to
section
408
of
FFDCA,
21
U.
S.
C.
346a,
as
amended
by
FQPA
(
Public
Law
104
 
170),
announcing
the
filing
of
a
pesticide
petition
(
PP
7F4850)
by
AgrEvo.
Since
1997,
by
a
series
of
mergers,
AgrEvo
became
Aventis
Crop
Science
and
then
Bayer
CropScience.
That
notice
included
a
summary
of
the
petition
prepared
by
AgrEvo,
now
doing
business
as
Bayer
CropScience,
2
T.
W.
Alexander
Dr.,
Research
Triangle
Park,
NC
27709.
There
were
no
comments
received
in
response
to
the
notice
of
filing.
The
petition
requested
that
40
CFR
180.509
be
amended
by
establishing
permanent
tolerances
for
the
combined
residues
of
the
herbicide
safener,
mefenpyr­
diethyl,
1­(
2,4­
dichlorophenyl)­
4,5­
dihydro­
5­
methyl­
1H­
pyrazole­
3,5­
dicarboxylic
acid,
diethyl
ester,
in
or
on
wheat
and
barley
commodities.
In
the
Federal
Register
of
August
8,
1997
(
62
FR
42678)
(
FRL
 
5731
 
7),
EPA,
on
its
own
initiative,
pursuant
to
section
408(
e)
and
(
1)(
6)
of
the
FFDCA,
established
time­
limited
tolerances
for
the
inert
ingredient
herbicide
safener,
mefenpyr­
diethyl,
and
its
2,4­
dichlorophenyl­
pyrazoline
metabolites
in
or
on
wheat
grain
and
wheat
straw.
This
action
was
in
response
to
EPA's
granting
of
an
emergency
exemption
under
section
18
of
the
Federal
Insecticide,
Fungicide,
and
Rodenticide
Act
(
FIFRA)
authorizing
use
of
mefenpyr­
diethyl
on
wheat
grain
and
wheat
straw
in
North
Dakota
and
Montana.
Similarly,
mefenpyr­
diethyl
timelimited
tolerances
were
established
by
the
Agency
in
the
Federal
Register
of
September
9,
1998
(
63
FR
48116)
(
FRL
 
6024
 
7),
in
or
on
barley
grain,
barley
hay,
barley
straw,
and
the
processed
byproducts
of
barley
grain:
pearled
barley,
bran
and
flour.
This
action
was
in
response
to
EPA's
granting
of
an
emergency
exemption
under
FIFRA
section
18
authorizing
use
of
mefenpyrdiethyl
on
barley
in
North
Dakota.
These
time­
limited
tolerances
have
been
extended
as
the
petitioner
has
continued
data
generation.
(
See
the
Federal
Register
of
May
6,
1998
(
63
FR
24939)
(
FRL
 
5788
 
1);
the
Federal
Register
of
November
22,
1999
(
64
FR
63711)
(
FRL
 
6385
 
5);
and
the
Federal
Register
of
December
14,
2001
(
66
FR
64768)
(
FRL
 
6814
 
2)).
The
extensions
of
these
time­
limited
tolerances
were
consistent
with
the
safety
standard
(
FFDCA
section
408(
b)(
2))
and
FIFRA
section
18.
Currently,
the
time­
limited
tolerances
under
40
CFR
180.509(
b)
expire
on
December
31,
2003.
As
the
permanent
tolerances
are
established,
these
emergency
exemption
timelimited
tolerances
are
no
longer
necessary
and
will
be
revoked.
Section
408(
b)(
2)(
A)(
i)
of
the
FFDCA
allows
EPA
to
establish
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(
b)(
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.
.
.
.''
EPA
performs
a
number
of
analyses
to
determine
the
risks
from
aggregate
exposure
to
pesticide
residues.
For
further
discussion
of
the
regulatory
requirements
of
section
408
of
the
FFDCA
and
a
complete
description
of
the
risk
assessment
process,
see
the
final
rule
on
Bifenthrin
Pesticide
Tolerances
(
62
FR
62961,
November
26,
1997)
(
FRL
 
5754
 
7).

III.
Aggregate
Risk
Assessment
and
Determination
of
Safety
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.
EPA
has
sufficient
data
to
assess
the
hazards
of
and
to
make
a
determination
on
aggregate
exposure,
consistent
with
section
408(
b)(
2)
of
the
FFDCA,
for
tolerances
for
combined
residues
of
mefenpyr­
diethyl
on
wheat
and
barley
commodities.
EPA's
assessment
of
exposures
and
risks
associated
with
establishing
the
tolerances
follows.

A.
Toxicological
Profile
EPA
has
evaluated
the
available
toxicity
data
and
considered
its
validity,
completeness,
and
reliability
as
well
as
the
relationship
of
the
results
of
the
studies
to
human
risk.
EPA
has
also
considered
available
information
concerning
the
variability
of
the
sensitivities
of
major
identifiable
subgroups
of
consumers,
including
infants
and
children.
The
nature
of
the
toxic
effects
caused
by
mefenpyr­
diethyl
are
discussed
in
Table
1
of
this
unit
as
well
as
the
no
observed
adverse
effect
level
(
NOAEL)
and
the
lowest
observed
adverse
effect
level
(
LOAEL)
from
the
toxicity
studies
reviewed.

TABLE
1.
 
SUBCHRONIC,
CHRONIC,
AND
OTHER
TOXICITY
Guideline
No.
Study
Type
Results
870.3100
Subchronic
feeding
studies
in
mouse
NOAEL
=
89.3/
105.4
mg/
kg/
day
(
milligram/
kilogram/
day),
male
and
female
(
M/
F)
LOAEL
=
449.0/
523.5
mg/
kg/
day
(
M/
F)
based
on
decreased
body
and
kidney
weight,
increased
liver
weight
and
hepatocyte
hypertrophy
in
males;
decreased
bilirubin
and
increased
lactic
acid
dehydrogenase
values
in
females
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83
/
Wednesday,
April
30,
2003
/
Rules
and
Regulations
TABLE
1.
 
SUBCHRONIC,
CHRONIC,
AND
OTHER
TOXICITY
 
Continued
Guideline
No.
Study
Type
Results
870.3100
Subchronic
feeding
studies
in
rats
NOAEL
=
206.7/
223.0
mg/
kg/
day
(
M/
F)
LOAEL
=
660.6/
708.9
mg/
kg/
day(
M/
F)
based
on
decreased
body
weight
(
bwt)
gains;
decreased
erythrocyte
counts,
hemoglobin
and
hematocrit
values;
and
increased
reticulocyte
counts
and
mean
corpuscular
volume
870.3150
Subchronic
feeding­
dogs
NOAEL
=
80.5/
81.2
mg/
kg/
day
(
M/
F)
LOAEL
=
341.0/
336.1
mg/
kg/
day
(
M/
F)
based
on
increased
absolute
and
relative
liver
weights
and
alkaline
phosphatase
activities
in
both
sexes;
focal
liver
lesions
in
females;
slight
anemia
in
both
sexes;
decrease
in
mean
bwt
and
bwt
gain
in
females
and
decreased
food
consumption
in
both
sexes
870.3200
28
 
Day
dermal
toxicity
(
rat)
NOAEL
=
1,000
mg/
kg/
day
highest
dose
tested
(
HDT)
LOAEL
was
not
determined,
but
would
be
greater
than
the
NOAEL
870.3700
Developmental
toxicity
in
rodents
(
rat)
Maternal
NOAEL
<
1,000
mg/
kg/
day
Maternal
LOAEL
=
1,000
mg/
kg/
day
based
on
decrease
in
body
weight
gain
and
food
efficiency
during
the
first
week
of
treatment
and
on
increase
in
absolute
and
relative
spleen
weights
Developmental
NOAEL
=
1,000
mg/
kg/
day
Developmental
LOAEL
=
Not
determined
but
would
be
greater
than
the
NOAEL.
Note
that
only
one
dose
was
tested
870.3700
Postnatal
developmental
toxicity
in
rodents
(
rat)
Maternal
NOAEL
<
1,000
mg/
kg/
day
Maternal
NOAEL
=
1,000
mg/
kg/
day
based
on
decrease
in
bwt
gain
and
food
efficiency
during
the
first
week
of
treatment
Developmental
NOAEL
<
1,000
mg/
kg/
day
Developmental
LOAEL
=
1,000
mg/
kg/
day
based
on
marginal
decreases
in
fetal
bwt
and
bwt
gain
during
lactation.
Note
that
only
one
dose
was
tested
870.3700
Developmental
Toxicity
in
nonrodents
(
rabbit)
Maternal
NOAEL=
100
mg/
kg/
day
Maternal
LOAEL
=
250
mg/
kg/
day
based
on
higher
rate
of
abortions
and
marginal
decreases
in
body­
weight
gain,
food
efficiency
index
and
food
consumption
Developmental
NOAEL
=
100
mg/
kg/
day
LOAEL
=
250
mg/
kg/
day
based
on
higher
rate
of
abortions
870.3800
Reproduction
and
fertility
effects
Parental­
Offspring/
Systemic
NOAEL
=
57.3/
76.0
mg/
kg/
day
(
M/
F)
Parental­
Offspring/
Systemic
LOAEL=
306.0/
392.0
mg/
kg/
day
(
M/
F)
based
on
decrease
mean
bwt
and
mean
bwt
gain
in
parents
and
offspring
and
an
increase
in
mean
spleen
weight
an
increase
in
the
severity
(
but
not
in
the
incidence)
of
splenic
extramedullary
hematopoiesis
in
females.
Reproductive
NOAEL
=
306.0/
392.0
mg/
kg/
day
(
M/
F):
HDT
Reproductive
LOAEL
was
not
determined
but
would
be
greater
than
the
NOAEL
870.4100
Chronic­
feeding
toxicitydogs
NOAEL
=
51.4/
57.6
mg/
kg/
day
(
M/
F)
LOAEL
=
260.2/
282.2
mg/
kg/
day
(
M/
F)
based
on
high
ALP
levels
and
increased
absolute
and
relative
liver
weights
in
both
sexes
and
grade
1
(
minimal)
intrahepatic
cholestasis
in
the
liver:
2/
sex
870.4300
Chronic
Toxicity­
Carcinogenicity
rats
NOAEL
=
48.5/
60.0
mg/
kg/
day
(
M/
F)
LOAEL
=
251.6/
318.0
mg/
kg/
day
(
M/
F)
based
on
significant
increases
in
reticulocyte
counts
870.4300
Carcinogenicity
mice
NOAEL
=
350.8/
463.4
mg/
kg/
day
(
M/
F)
LOAEL
=
(
M/
F)
not
determined,
however,
study
considered
adequate
for
carcinogenicity
based
on
results
of
subchronic
study
870.5265
Gene
Mutation
Salmonella
and
E.
Coli
Non­
mutagenic
with
or
without
activation
870.5300
Gene
Mutation
HGPRT
with
V79
cells
Non­
mutagenic
with
or
without
activation
870.5375
Chinese
Hamster
Lung
Fibroblast
Assay
No
clastogenic
response
with
or
without
activation
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Vol.
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No.
83
/
Wednesday,
April
30,
2003
/
Rules
and
Regulations
TABLE
1.
 
SUBCHRONIC,
CHRONIC,
AND
OTHER
TOXICITY
 
Continued
Guideline
No.
Study
Type
Results
870.5395
Micronucleus
Assay
No
clastogenic
response
at
any
dose
or
sacrifice
time
870.5550
Unschedule
DNA
synthesis
No
clear
evidence
of
genotoxicity.
However,
study
not
acceptable
870.7485
Metabolism
and
pharmacokinetics
Single
dose
of
1
or
100
mg/
kg
bwt:
Urinary
excretion
­
76
 
88%
of
administered
radioactivity
with
59
 
72%
excreted
within
first
24
hours.
Fecal
excretion
ranged
from
13
 
32%.
83
 
91%
of
administered
dose
excreted
(
urine
and
feces)
by
24
hours
and
91
to
>
99%
excreted
by
48
hours.
At
least
68
 
88%
of
administered
dose
absorbed.
Recovery
in
tissues/
animal:
0.24%
of
administered
radioactivity
(
range:
0.07
 
0.51%).
General
order
of
concentration
plasma
>
whole
blood
>
lungs
>
subcutaneous
fat
>
heart
>
kidneys
>
retroperitoneal
fat
>
liver
>
gonads
>
pancreas
>
skeletal
muscle.
No
volatile
radioactivity
detected
0
 
24
hours
after
dosing.
Between
100
 
106%
of
administered
radioactivity
recovered.
Single
dose
of
1
or
100
mg/
kg
bwt:
Radioactivity
rapidly
excreted:
total
of
78
 
92%
excreted
by
48
hours.
Renal
excretion
predominant
route
of
elimination
(
65
 
72%
by
48
hours),
indicating
that
at
least
65
 
72%
of
the
administered
dose
was
absorbed.
None
of
test
material
found
in
its
original
form
in
urine.
Three
metabolites
identified
in
urine:
13
 
26%
of
the
radioactivity
was
recovered
in
the
feces
by
48
hours.
The
same
three
metabolites
identified
in
urine
were
also
present
in
the
feces:
Proposed
metabolic
steps:
Consecutive
hydrolysis
(
saponification)
of
the
two
carboxylic
acid
ester
groups
and
a
decarboxylation
of
one
of
the
carboxylic
groups,
resulting
in
an
aromatization
of
the
pyrazoline
ring.
Enterohepatic
circulation
is
unlikely
to
play
a
major
role.
In
males,
there
appears
to
be
either
lower
intestinal
absorption
or
a
higher
biliary
excretion
when
compared
to
females.

B.
Toxicological
Endpoints
The
dose
at
which
the
NOAEL
from
the
toxicology
study
identified
as
appropriate
for
use
in
risk
assessment
is
used
to
estimate
the
toxicological
level
of
concern
(
LOC).
An
uncertainty
factor
(
UF)
is
applied
to
reflect
uncertainties
inherent
in
the
extrapolation
from
laboratory
animal
data
to
humans
and
in
the
variations
in
sensitivity
among
members
of
the
human
population
as
well
as
other
unknowns.
An
UF
of
100
is
routinely
used,
10X
to
account
for
interspecies
differences
and
10X
for
intraspecies
differences.
For
dietary
risk
assessment
(
other
than
cancer)
the
Agency
uses
the
UF
to
calculate
an
acute
or
chronic
reference
dose
(
acute
RfD
or
chronic
RfD)
where
the
RfD
is
equal
to
the
NOAEL
divided
by
the
appropriate
UF
(
RfD
=
NOAEL/
UF).
Where
an
additional
safety
factor
(
SF)
is
retained
due
to
concerns
unique
to
the
FQPA,
this
additional
factor
is
applied
to
the
RfD
by
dividing
the
RfD
by
such
additional
factor.
The
acute
or
chronic
Population
Adjusted
Dose
(
aPAD
or
cPAD)
is
a
modification
of
the
RfD
to
accommodate
this
type
of
FQPA
SF.
For
non­
dietary
risk
assessments
(
other
than
cancer)
the
UF
is
used
to
determine
the
LOC.
For
example,
when
100
is
the
appropriate
UF
(
10X
to
account
for
interspecies
differences
and
10X
for
intraspecies
differences)
the
LOC
is
100.
To
estimate
risk,
a
ratio
of
the
NOAEL
to
exposures
(
margin
of
exposure
(
MOE)
=
NOAEL/
exposure)
is
calculated
and
compared
to
the
LOC.
A
summary
of
the
toxicological
endpoints
for
mefenpyr­
diethyl
used
for
human
risk
assessment
is
discussed
in
this
unit:
The
Agency
has
determined
that
there
is
no
acute
toxicological
concern.
No
appropriate
endpoint
was
identified
from
oral
toxicity
studies
including
the
developmental
toxicity
studies
in
rats
and
rabbits.
No
shortterm
or
intermediate­
term
dermal
or
systemic
toxicity
was
observed
up
to
1,000
mg/
kg/
day
and
no
development
effects
were
observed
in
the
developmental
rat
study
at
1,000
mg/
kg/
day.
Therefore,
no
endpoint
was
identified
for
risk
assessment
for
the
short­
and
intermediate­
term
risk
assessments.
Based
on
the
current
usepattern
(
i.
e.
one
application
per
season)
long­
term
exposure
via
the
dermal
route
is
not
expected.
Therefore,
a
long­
term
dermal
end­
point
was
not
identified.
Similarly,
no
endpoint
was
identified
for
carcinogenicity
since
this
chemical
is
not
classified
as
a
human
carcinogen.
For
chronic
dietary
risk
assessment
the
NOAEL
of
57.3
mg/
kg/
day
in
a
2
 
generation
reproduction
toxicity
study
was
identified
as
an
appropriate
end
point.
Taking
into
account
the
UF
of
100,
the
chronic
RfD
is
0.57
mg/
kg/
day
(
NOAEL
57.3/
UF
100
=
0.57).
The
Agency
has
used
a
FQPA
Factor
of
1
and
therefore,
the
chronic
population
adjusted
dose
(
PAD)
is
0.57
mg/
kg/
day
(
RfD
0.57/
FQPA
1
=
0.57)
for
mefenpyrdiethyl

C.
Exposure
Assessment
1.
Dietary
exposure
from
food
and
feed
uses.
Tolerances
have
been
previously
established
(
40
CFR
180.509(
b))
under
FIFRA
section
18,
the
Emergency
Exemption
Program,
for
the
combined
residues
of
mefenpyr­
diethyl.
To
establish
permanent
tolerances,
risk
assessments
were
conducted
by
EPA
to
assess
dietary
exposures
from
mefenpyrdiethyl
in
food
as
follows:
i.
Acute
exposure.
Acute
dietary
risk
assessments
are
performed
for
a
fooduse
pesticide
if
a
toxicological
study
has
indicated
the
possibility
of
an
effect
of
concern
occurring
as
a
result
of
a
1­
day
or
single
exposure.
An
acute
dietary
risk
assessment
was
not
performed
because
no
appropriate
acute
toxicological
endpoint
could
be
identified
in
any
of
the
oral
toxicity
studies
including
the
developmental
studies
in
rats
and
rabbits.
ii.
Chronic
exposure.
The
chronic
dietary
exposure
assessment
was
conducted
using
the
Dietary
Exposure
Evaluation
Model
software
with
the
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/
Vol.
68,
No.
83
/
Wednesday,
April
30,
2003
/
Rules
and
Regulations
Food
Commodity
Intake
Database
(
DEEM­
FCID
 
,
Version
1.3),
which
incorporates
consumption
data
from
USDA's
Continuing
Survey
of
Food
Intakes
by
Individuals
(
CSFII),
1994
 
1996
and
1998.
The
1994
 
96
and
1998
data
are
based
on
the
reported
consumption
of
more
than
20,000
individuals
over
two
non­
consecutive
survey
days.
Foods
``
as
consumed''
(
e.
g.,
apple
pie)
are
linked
to
EPA­
defined
food
commodities
(
e.
g.
apples,
peeled
fruit
­
cooked;
fresh
or
not
specified
(
N/
S);
baked;
or
wheat
flour
­
cooked;
fresh
or
N/
S,
baked)
using
publicly
available
recipe
translation
files
developed
jointly
by
USDA/
ARS
and
EPA.
Consumption
data
are
averaged
for
the
entire
U.
S.
population
and
within
population
subgroups
for
chronic
exposure
assessment,
but
are
retained
as
individual
consumption
events
for
acute
exposure
assessment.
For
chronic
exposure
and
risk
assessment,
an
estimate
of
the
residue
level
in
each
food
or
food­
form
(
e.
g.,
orange
or
orange
juice)
on
the
food
commodity
residue
list
is
multiplied
by
the
average
daily
consumption
estimate
for
that
food/
food
form.
The
resulting
residue
consumption
estimate
for
each
food/
food
form
is
summed
with
the
residue
consumption
estimates
for
all
other
food/
food
forms
on
the
commodity
residue
list
to
arrive
at
the
total
average
estimated
exposure.
Exposure
is
expressed
in
mg/
kg
bwt/
day
and
as
a
percent
of
the
cPAD.
This
procedure
is
performed
for
each
population
subgroup.
The
DEEM­
FCID
 
analyses
estimate
the
dietary
exposure
of
the
U.
S.
population
and
various
population
subgroups.
The
analysis
assumed
tolerance­
level
residues.
No
processing
studies
were
required
due
to
the
fact
that
field
trials
conducted
at
exaggerated
rate
(
greater
than
5X)
showed
no
detectable
residues
in
wheat
and
barley
grains.
Therefore,
no
tolerance
is
needed
for
processed
commodities.
A
default
processing
factor
of
1.92
was
used
for
dried
beef
in
this
dietary
exposure
analysis.
No
other
commodities
in
this
analysis
used
DEEM
default
processing
factors.
No
percent
crop
treated
or
anticipated
residues
were
used.
iii.
Cancer.
The
Agency
has
determined
that
mefenpyr­
diethyl
is
``
not
likely
to
be
a
human
carcinogen.''
This
was
based
on
weight­
of­
theevidence
from
negative
rat
and
mouse
carcinogenicity
studies
as
well
as
negative
mutagenicity
studies.
Therefore,
a
carcinogenic
dietary
assessment
was
not
performed.
2.
Dietary
exposure
from
drinking
water.
The
Agency
lacks
sufficient
monitoring
exposure
data
to
complete
a
comprehensive
dietary
exposure
analysis
and
risk
assessment
for
mefenpyr­
diethyl
in
drinking
water.
Because
the
Agency
does
not
have
comprehensive
monitoring
data,
drinking
water
concentration
estimates
are
made
by
reliance
on
simulation
or
modeling
taking
into
account
data
on
the
physical
characteristics
of
mefenpyrdiethyl
The
Agency
used
the
FQPA
Index
Reservoir
Screening
Tool
(
FIRST)
to
produce
estimates
of
pesticide
concentrations
in
an
index
reservoir.
The
screening
concentration
in
ground
water
(
SCI­
GROW2)
model
is
used
to
predict
pesticide
concentrations
in
shallow
ground
water.
FIRST
is
a
tier
1
model
that
uses
a
specific
high­
end
runoff
scenario
for
pesticides.
It
incorporates
an
index
reservoir
environment,
but
does
include
a
percent
crop
area
factor
as
an
adjustment
to
account
for
the
maximum
percent
crop
coverage
within
a
watershed
or
drainage
basin.
Neither
FIRST
nor
SCI­
GROW2
include
consideration
of
the
impact
processing
(
mixing,
dilution,
or
treatment)
of
raw
water
for
distribution
as
drinking
water
would
likely
have
on
the
removal
of
pesticides
from
the
source
water.
The
primary
use
of
models
by
the
Agency
at
this
stage
is
to
provide
a
coarse
screen
for
sorting
out
pesticides
for
which
it
is
highly
unlikely
that
drinking
water
concentrations
would
ever
exceed
human
health
levels
of
concern.
Since
FIRST
and
SCI­
GROW2
is
considered
to
be
a
screening
tool
in
the
risk
assessment
process,
the
Agency
does
not
use
estimated
environmental
concentrations
(
EECs)
from
these
models
to
quantify
drinking
water
exposure
and
risk
as
a
%
RfD
or
%
PAD.
Instead
drinking
water
levels
of
comparison
(
DWLOCs)
are
calculated
and
used
as
a
point
of
comparison
against
the
model
estimates
of
a
pesticide's
concentration
in
water.
DWLOCs
are
theoretical
upper
limits
on
a
pesticide's
concentration
in
drinking
water
in
light
of
total
aggregate
exposure
to
a
pesticide
in
food,
and
from
residential
uses.
Since
DWLOCs
address
total
aggregate
exposure
to
mefenpyrdiethyl
they
are
further
discussed
in
the
aggregate
risk
sections
see
Unit
III.
E.
The
EECs
for
a
single
application
of
mefenpyr­
diethyl
at
an
exaggerated
rate
of
0.090
kg/
hectare
(
ha)
(
0.080
lb/
acre)
results
in
the
peak
and
chronic
concentrations
of
combined
parent
and
metabolites
of
5
parts
per
billion
(
ppb)
and
3
ppb,
respectively
for
surface
water
and
4
ppb
for
ground
water.
3.
From
non­
dietary
exposure.
The
term
``
residential
exposure''
is
used
in
this
document
to
refer
to
nonoccupational
non­
dietary
exposure
(
e.
g.,
for
lawn
and
garden
pest
control,
indoor
pest
control,
termiticides,
and
flea
and
tick
control
on
pets).
Mefenpyrdiethyl
is
not
registered
for
use
on
any
sites
that
would
result
in
residential
exposure.
4.
Cumulative
exposure
to
substances
with
a
common
mechanism
of
toxicity.
Section
408(
b)(
2)(
D)(
v)
of
the
FFDCA
requires
that,
when
considering
whether
to
establish,
modify,
or
revoke
a
tolerance,
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
does
not
have,
at
this
time,
available
data
to
determine
whether
mefenpyr­
diethyl
has
a
common
mechanism
of
toxicity
with
other
substances
or
how
to
include
this
pesticide
in
a
cumulative
risk
assessment.
Unlike
other
pesticides
for
which
EPA
has
followed
a
cumulative
risk
approach
based
on
a
common
mechanism
of
toxicity,
mefenpyrdiethyl
does
not
appear
to
produce
a
toxic
metabolite
produced
by
other
substances.
For
the
purposes
of
this
tolerance
action,
therefore,
EPA
has
not
assumed
that
mefenpyr­
diethyl
has
a
common
mechanism
of
toxicity
with
other
substances.
For
information
regarding
EPA's
efforts
to
determine
which
chemicals
have
a
common
mechanism
of
toxicity
and
to
evaluate
the
cumulative
effects
of
such
chemicals,
see
the
final
rule
for
Bifenthrin
Pesticide
Tolerances
(
62
FR
62961,
November
26,
1997).

D.
Safety
Factor
for
Infants
and
Children
1.
In
general.
Section
408
of
the
FFDCA
provides
that
EPA
shall
apply
an
additional
tenfold
margin
of
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
safety
will
be
safe
for
infants
and
children.
Margins
of
safety
are
incorporated
into
EPA
risk
assessments
either
directly
through
use
of
a
MOE
analysis
or
through
using
uncertainty
(
safety)
factors
in
calculating
a
dose
level
that
poses
no
appreciable
risk
to
humans.
2.
Prenatal
and
postnatal
sensitivity.
In
the
prenatal
developmental
toxicity
study
in
rats,
no
evidence
of
developmental
toxicity
was
seen,
even
in
the
presence
of
maternal
toxicity.
In
the
developmental
toxicity
study
in
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Rules
and
Regulations
rabbits,
developmental
toxicity
was
seen
in
the
presence
of
maternal
toxicity.
A
higher
rate
of
abortions
occurred
at
the
highest
dose
level
tested
(
250
mg/
kg/
day).
An
examination
of
the
individual
litter
data
provided
no
evidence
as
to
whether
or
not
the
higher
rate
was
due
to
maternal
toxicity
or
developmental
toxicity.
Therefore,
both
the
maternal
and
developmental
NOAELs
and
LOAELs
were
based
on
this
effect.
In
the
2
 
generation
reproduction
study
and
in
the
postnatal
developmental
toxicity
study
in
rats,
effects
in
the
offspring
were
observed
only
at
or
above
treatment
levels
which
caused
parental
toxicity.
Developmental
(
Offspring)
effects
in
these
two
studies
consisted
of
decreases
in
bwt
and
bwt
gain
of
the
pups
in
the
presence
of
either
decreased
bwt
and
bwt
gain
or
hematopoietic
effects
in
the
parents.
There
does
not
appear
to
be
any
increased
susceptibility
in
rats
or
rabbits
to
in
utero
and/
or
postnatal
exposure
to
mefenpyr­
diethyl.
Developmental
effects
were
only
observed
at
levels
which
were
parentally
toxic.
3.
Conclusion.
There
is
a
complete
toxicity
data
base
for
mefenpyr­
diethyl
and
exposure
data
are
complete
or
are
estimated
based
on
data
that
reasonably
accounts
for
potential
exposures.
EPA
determined
that
the
10X
safety
factor
to
protect
infants
and
children
should
be
removed.
The
FQPA
factor
is
removed
(
i.
e.,
reduced
to
1)
because
there
is
no
indication
of
increased
susceptibility
to
infants
and
children,
dietary
exposure
estimates
are
likely
to
result
in
an
overestimate
of
the
actual
exposure,
estimates
for
ground
and
surface
source
drinking
water
exposure
are
upperbound
concentrations
and
there
are
currently
no
registered
residential
uses
and
thus,
this
type
of
exposure
to
infants
and
children
is
not
expected.

E.
Aggregate
Risks
and
Determination
of
Safety
To
estimate
total
aggregate
exposure
to
a
pesticide
from
food,
drinking
water,
and
residential
uses,
the
Agency
calculates
DWLOCs
which
are
used
as
a
point
of
comparison
against
the
model
estimates
of
a
pesticide's
concentration
in
water
(
EECs).
DWLOC
values
are
not
regulatory
standards
for
drinking
water.
DWLOCs
are
theoretical
upper
limits
on
a
pesticide's
concentration
in
drinking
water
in
light
of
total
aggregate
exposure
to
a
pesticide
in
food
and
residential
uses.
In
calculating
a
DWLOC,
the
Agency
determines
how
much
of
the
acceptable
exposure
(
i.
e.,
the
PAD)
is
available
for
exposure
through
drinking
water
(
e.
g.,
allowable
chronic
water
exposure
(
mg/
kg/
day)
=
cPAD
­
(
average
food
+
residential
exposure)).
This
allowable
exposure
through
drinking
water
is
used
to
calculate
a
DWLOC.
A
DWLOC
will
vary
depending
on
the
toxic
endpoint,
drinking
water
consumption,
and
bwts.
Default
bwts
and
consumption
values
as
used
by
EPA
are
used
to
calculate
DWLOCs:
2
liter
(
L)/
70
kg
(
adult
male),
2L/
60
kg
(
adult
female),
and
1L/
10
kg
(
child).
Default
bwts
and
drinking
water
consumption
values
vary
on
an
individual
basis.
This
variation
will
be
taken
into
account
in
more
refined
screening­
level
and
quantitative
drinking
water
exposure
assessments.
Different
populations
will
have
different
DWLOCs.
Generally,
a
DWLOC
is
calculated
for
each
type
of
risk
assessment
used:
Acute,
short­
term,
intermediate­
term,
chronic,
and
cancer.
When
EECs
for
surface
water
and
ground
water
are
less
than
the
calculated
DWLOCs,
EPA
concludes
with
reasonable
certainty
that
exposures
to
the
pesticide
in
drinking
water
(
when
considered
along
with
other
sources
of
exposure
for
which
the
Agency
has
reliable
data)
would
not
result
in
unacceptable
levels
of
aggregate
human
health
risk
at
this
time.
Because
the
Agency
considers
the
aggregate
risk
resulting
from
multiple
exposure
pathways
associated
with
a
pesticide's
uses,
levels
of
comparison
in
drinking
water
may
vary
as
those
uses
change.
If
new
uses
are
added
in
the
future,
the
Agency
will
reassess
the
potential
impacts
of
residues
of
the
pesticide
in
drinking
water
as
a
part
of
the
aggregate
risk
assessment
process.
1.
Acute
risk.
No
acute
endpoint
was
identified,
therefore,
no
acute
risk
is
expected.
2.
Chronic
risk.
EPA
has
concluded
that
exposure
to
mefenpyr­
diethyl
from
food
will
utilize
less
than
1%
of
the
cPAD
for
the
U.
S.
population
and
all
population
subgroups.
(
Table
2).
There
are
no
residential
uses
for
mefenpyrdiethyl
that
result
in
chronic
residential
exposure
to
mefenpyr­
diethyl.
The
following
table
represents
the
results
of
the
Tier
1
chronic
dietary
(
food
only)
exposure
analysis
for
mefenpyr­
diethyl
proposed
uses
on
barley
and
wheat.

TABLE
2.
 
EXPOSURE
AND
RISK
ESTIMATES
FOR
DIETARY
(
FOOD
ONLY)
EXPOSURE
TO
MEFENPYR­
DIETHYL.

Population
Subgroup
Estimated
Dietary
Exposure
mg/
kg
bwt/
day
%
cPAD
U.
S.
population
0.000113
<
1%

All
infants
(<
1
year)
0.000068
<
1%

Children
(
1
 
2
years)
0.000295
<
1%

Children
(
3
 
5
years)
0.000273
<
1%

Children
(
6
 
12
years)
0.000186
<
1%

Youth
(
13
 
19
years)
0.000107
<
1%

Adults
(
20
 
49
years)
0.000091
<
1%

Females
(
13
 
49
years)
0.000082
<
1%

Adults
(
50+
years)
0.000074
<
1%

This
exposure
analysis
and
cPAD
represents
a
conservative
estimate
of
dietary
(
food
only)
exposure
and
risk
from
the
use
of
mefenpyr­
diethyl
on
barley
and
wheat.
Further
refinement,
through
the
use
of
anticipated
residues,
percent­
of­
crop
treated
estimates
and/
or
monitoring
data,
would
result
in
a
reduction
in
the
exposure
estimates
and
the
associated
risk.
However,
in
this
analysis,
even
without
further
refinement,
the
risk
estimate
for
all
population
subgroups
is
less
than
1%
of
the
cPAD.
This
is
below
the
Agency's
level
of
concern
(
100%
of
the
cPAD)
for
the
general
U.
S.
population
and
all
population
subgroups.
However,
there
is
potential
for
chronic
dietary
exposure
to
mefenpyrdiethyl
in
drinking
water.
The
EECs
for
surface
water
and
ground
water
are
less
than
the
DWLOC.
Thus,
EPA
does
not
expect
the
aggregate
exposure
to
exceed
100%
of
the
cPAD,
as
shown
in
Table
3
below.

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Rules
and
Regulations
TABLE
3.
 
AGGREGATE
RISK
ASSESSMENT
FOR
CHRONIC
(
NON­
CANCER)
EXPOSURE
TO
MEFENPYR­
DIETHYL
Population
Subgroup
cPAD
(
mg/
kg/
day)
%
cPAD
(
food)
Surface
Water
EEC
(
ppb)
Ground
Water
EEC
(
ppb)
Chronic
DWLOC
(
ppb)

U.
S.
population
0.57
0.000113
3
4
20,000
All
infants
(<
1
year
old)
0.57
0.00007
3
4
5,700
Children
(
1
 
2
years
old)
0.57
0.000295
3
4
5,700
Females
(
13
 
49
years
old)
0.57
0.00008
3
4
17,000
3.
Short­
term
risk
and
intermediateterm
risk.
Mefenpyr­
diethyl
is
not
registered
for
use
on
any
sites
that
would
result
in
residential
exposure.
4.
Aggregate
cancer
risk
for
U.
S.
population.
Mefenpyr­
diethyl
is
not
classified
as
a
human
carcinogen
and
thus
is
not
expected
to
pose
a
cancer
risk.
5.
Determination
of
safety.
Based
on
these
risk
assessments,
EPA
concludes
that
there
is
a
reasonable
certainty
that
no
harm
will
result
to
the
general
population,
and
to
infants
and
children
from
aggregate
exposure
to
mefenpyrdiethyl
residues.

IV.
Other
Considerations
A.
Analytical
Enforcement
Methodology
The
petitioner
has
submitted
an
analytical
method
for
mefenpyr­
diethyl
and
its
metabolites
in
wheat
and
barley
using
Gas
Chromatography
with
a
Mass
Selective
Detection
(
GC/
MSD).
This
enforcement
method
has
been
reviewed
by
the
Agency
and
fulfills
the
guidelines.
The
petitioner
also
submitted
an
analytical
method
for
mefenpyr­
diethyl
and
its
metabolites
in
Beef
Liver
also
using
GC/
MSD.
The
petitioner
also
submitted
an
Independent
Laboratory
Validation
of
the
method.
Adequate
enforcement
methodology
GC/
MSD
is
available
to
enforce
the
tolerance
expression.
The
method
may
be
requested
from:
Chief,
Analytical
Chemistry
Branch,
Environmental
Science
Center,
701
Mapes
Rd.,
Ft.
Meade,
MD
20755
 
5350;
telephone
number:
(
410)
305
 
2905;
e­
mail
address:
residuemethods@
epa.
gov.

B.
International
Residue
Limits
There
are
no
CODEX,
Canadian
or
Mexican
limits
for
residues
of
mefenpyr­
diethyl
in
wheat
and
barley.
However,
Italy
has
established
an
MRL
(
maximum
residue
limit)
of
0.05
ppm
in
wheat
grain
for
residues
of
mefenpyrdiethyl
and
its
metabolites
which
is
consistent
with
the
wheat
grain
tolerance
established
today.
C.
Conditions
Based
on
the
residue
uptake
results
of
the
confined
rotational
studies
at
90
gram/
hectare
(
0.80
lb/
acre)
residue
uptakes,
the
Agency
would
usually
establish
a
30
 
day
plantback
interval
for
leafy,
fruiting,
and
root
vegetables,
and
12
 
month
plantback
interval
for
all
other
crops
other
than
wheat
and
barley,
which
can
be
replanted
at
any
time.
However,
at
this
time,
the
petitioner
has
indicated
that
the
application
rate
will
not
exceed
30
gram/
hectare
or
0.0267
lb/
acre.
Given
this
reduction
to
one
 
third
of
the
application
rate
used
in
the
study,
the
Agency
believes
that
a
30
 
day
plantback
interval
is
appropriate
for
all
crops
except
cereal
grains
and
grasses.
The
plant
back
interval
for
cereal
grains
and
grasses,
except
wheat
and
barley,
(
which
can
be
replanted
at
any
time)
is
12
 
months.

V.
Conclusion
Therefore,
tolerances
are
established
for
the
combined
residues
of
mefenpyrdiethyl
1­(
2,4­
dichlorophenyl)­
4,5­
dihydro­
5­
methyl­
1H­
pyrazole­
3,5­
dicarboxylic
acid,
diethyl
ester,
in
or
on
wheat
and
barley
commodities.

VI.
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)
of
FFDCA,
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
 
0077
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
June
30,
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
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30,
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Rules
and
Regulations
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
VI.
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
 
0077,
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).

VII.
Statutory
and
Executive
Order
Reviews
This
final
rule
establishes
a
tolerance
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
tolerance
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.

VIII.
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
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30,
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/
Rules
and
Regulations
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:
April
17,
2003.
Peter
Caulkins,
Acting
Director,
Registration
Division,
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
180.509
is
revised
to
read
as
follows:

§
180.509
Mefenpyr­
diethyl;
tolerance
for
residues.

(
a)
General.
Tolerances
are
established
for
residues
of
the
herbicide
safener
mefenpyr­
diethyl
(
1­(
2,4­
dichlorophenyl)­
4,5­
dihydro­
5­
methyl­
1H­
pyrazole­
3,5­
dicarboxylic
acid,
diethyl
ester)
and
its
2,4­
dichlorophenyl­
pyrazoline
metabolites
at
a
rate
of
0.0267
pound
safener
per
acre
per
growing
season
in
or
on
following
commodities:

Commodity
Parts
per
million
Barley,
grain
.............................
0.05
Barley,
hay
................................
0.2
Barley,
straw
.............................
0.5
Cattle,
meat
byproducts
...........
0.1
Goat,
meat
byproducts
.............
0.1
Hog,
meat
byproducts
..............
0.1
Horse,
meat
byproducts
...........
0.1
Sheep,
meat
byproducts
..........
0.1
Wheat,
forage
...........................
0.2
Wheat,
grain
.............................
0.05
Wheat,
hay
...............................
0.2
Wheat,
straw
.............................
0.5
(
b)
Section
18
emergency
exemptions.
[
Reserved]
(
c)
Tolerances
with
regional
registrations.
[
Reserved]
(
d)
Indirect
or
inadvertent
residues.
[
Reserved]

[
FR
Doc.
03
 
10263
Filed
4
 
29
 
03;
8:
45
am]

BILLING
CODE
6560
 
50
 
S
ENVIRONMENTAL
PROTECTION
AGENCY
40
CFR
Part
180
[
OPP
 
2003
 
0110;
FRL
 
7300
 
9]

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

SUMMARY:
This
regulation
establishes
a
tolerance
for
combined
residues
of
pyraflufen­
ethyl
in
or
on
field
corn,
potato,
and
soybean.
Nichino
America
Incorporated
requested
these
tolerances
under
the
Federal
Food,
Drug,
and
Cosmetic
Act
(
FFDCA)
,
as
amended
by
the
Food
Quality
Protection
Act
of
1996
(
FQPA).
DATES:
This
regulation
is
effective
April
30,
2003.
Objections
and
requests
for
hearings,
identified
by
docket
ID
number
OPP
 
2003
 
0110,
must
be
received
on
or
before
June
30,
2003.
ADDRESSES:
Written
objections
and
hearing
requests
may
be
submitted
electronically,
by
mail,
or
through
hand
delivery/
courier.
Follow
the
detailed
instructions
as
provided
in
Unit
VI.
of
the
SUPPLEMENTARY
INFORMATION.

FOR
FURTHER
INFORMATION
CONTACT:
Joanne
I.
Miller,
Registration
Division
(
7505C),
Office
of
Pesticide
Programs,
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460
 
0001;
telephone
number:
(
703)
305
 
6224;
e­
mail
address:
miller.
joanne@
epa.
gov.

SUPPLEMENTARY
INFORMATION:

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

You
may
be
potentially
affected
by
this
action
if
you
an
agricultural
producer,
food
manufacturer,
or
pesticide
manufacturer.
Potentially
affected
entities
may
include,
but
are
not
limited
to:
 
Crop
production
(
NAICS
Code
111)
 
Animal
production
(
NAICS
Code
112)
 
Food
manufacturing
(
NAICS
Code
311)
 
Pesticide
manufacturing
(
NAICS
Code
32532)
This
listing
is
not
intended
to
be
exhaustive,
but
rather
provides
a
guide
for
readers
regarding
entities
likely
to
be
affected
by
this
action.
Other
types
of
entities
not
listed
in
this
unit
could
also
be
affected.
The
North
American
Industrial
Classification
System
(
NAICS)
codes
have
been
provided
to
assist
you
and
others
in
determining
whether
this
action
might
apply
to
certain
entities.
If
you
have
any
questions
regarding
the
applicability
of
this
action
to
a
particular
entity,
consult
the
person
listed
under
FOR
FURTHER
INFORMATION
CONTACT.

B.
How
Can
I
Get
Copies
of
this
Document
and
Other
Related
Information?
1.
Docket.
EPA
has
established
an
official
public
docket
for
this
action
under
docket
identification
(
ID)
number
OPP
 
2003
 
0110.
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/
4
0cfr180_
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
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