48302
Federal
Register
/
Vol.
68,
No.
156
/
Wednesday,
August
13,
2003
/
Rules
and
Regulations
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.
801et
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:
July
31,
2003.
Debra
Edwards,
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
180.548
is
amended
by
revising
the
table
to
paragraph
(
a)
to
read
as
follows:

§
180.548
Tralkoxydim;
tolerances
for
residues.

(
a)
*
*
*

Commodity
Parts
per
million
Expiration/
revocation
date
Barley,
grain
.....
0.02
5/
1/
05
Barley,
hay
........
0.02
5/
1/
05
Barley,
straw
.....
0.05
5/
1/
05
Wheat,
forage
0.05
5/
1/
05
Wheat,
grain
.....
0.02
5/
1/
05
Wheat,
hay
.......
0.02
5/
1/
05
Wheat,
straw
.....
0.05
5/
1/
05
*
*
*
*
*

[
FR
Doc.
03
 
20433
Filed
8
 
12
 
03;
8:
45
am]

BILLING
CODE
6560
 
50
 
S
ENVIRONMENTAL
PROTECTION
AGENCY
40
CFR
Part
180
[
OPP
 
2003
 
0251;
FRL
 
7319
 
5]

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

SUMMARY:
This
regulation
establishes
a
tolerance
for
residues
of
hydramethylnon
in
or
on
pineapple.
BASF
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
August
13,
2003.
Objections
and
requests
for
hearings,
identified
by
docket
ID
number
OPP
 
2003
 
0251,
must
be
received
on
or
before
October
14,
2003.

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/
Vol.
68,
No.
156
/
Wednesday,
August
13,
2003
/
Rules
and
Regulations
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:
Richard
J.
Gebken,
Registration
Division
(
7505C),
Office
of
Pesticide
Programs,
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460
 
0001;
telephone
number:
(
703)
305
 
6701;
e­
mail
address:
gebken.
richard@
epa.
gov.

SUPPLEMENTARY
INFORMATION:

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

You
may
be
potentially
affected
by
this
action
if
you
are
an
agricultural
producer,
food
manufacturer,
or
pesticide
manufacturer.
Potentially
affected
entities
may
include,
but
are
not
limited
to:
 
Crop
production
(
NAICS
111)
 
Food
manufacturing
(
NAICS
311)
 
Pesticide
manufacturing
(
NAICS
32532)
 
Animal
production
(
NAICS
112)
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
 
0251
The
official
public
docket
consists
of
the
documents
specifically
referenced
in
this
action,
any
public
comments
received,
and
other
information
related
to
this
action.
Although
a
part
of
the
official
docket,
the
public
docket
does
not
include
Confidential
Business
Information
(
CBI)
or
other
information
whose
disclosure
is
restricted
by
statute.
The
official
public
docket
is
the
collection
of
materials
that
is
available
for
public
viewing
at
the
Public
Information
and
Records
Integrity
Branch
(
PIRIB),
Rm.
119,
Crystal
Mall
#
2,
1921
Jefferson
Davis
Hwy.,
Arlington,
VA.
This
docket
facility
is
open
from
8:
30
a.
m.
to
4
p.
m.,
Monday
through
Friday,
excluding
legal
holidays.
The
docket
telephone
number
is
(
703)
305
 
5805.
2.
Electronic
access.
You
may
access
this
Federal
Register
document
electronically
through
the
EPA
Internet
under
the
``
Federal
Register''
listings
at
http://
www.
epa.
gov/
fedrgstr/.
A
frequently
updated
electronic
version
of
40
CFR
part
180
is
available
at
http://
www.
access.
gpo.
gov/
nara/
cfr/
cfrhtml_
00/
Title_
40/
40cfr180_
00.
html,
a
beta
site
currently
under
development.
To
access
the
OPPTS
Harmonized
Guidelines
referenced
in
this
document,
go
directly
to
the
guidelines
at
http://
www.
epa.
gov/
opptsfrs/
home/
guidelin.
htm.
An
electronic
version
of
the
public
docket
is
available
through
EPA's
electronic
public
docket
and
comment
system,
EPA
Dockets.
You
may
use
EPA
Dockets
at
http://
www.
epa.
gov/
edocket/
to
submit
or
view
public
comments,
access
the
index
listing
of
the
contents
of
the
official
public
docket,
and
to
access
those
documents
in
the
public
docket
that
are
available
electronically.
Although
not
all
docket
materials
may
be
available
electronically,
you
may
still
access
any
of
the
publicly
available
docket
materials
through
the
docket
facility
identified
in
Unit
I.
B.
1.
Once
in
the
system,
select
``
search,''
then
key
in
the
appropriate
docket
ID
number.

II.
Background
and
Statutory
Findings
In
the
Federal
Register
of
October
6,
1999
(
64
FR
Page
54300
 
54303)
(
FRL
 
6029
 
9),
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
2F02609)
by
BASF
Corporation,
26
Davis
Drive,
P.
O.
Box
13528,
Research
Triangle
Park,
NC
27709
 
3528.
That
notice
included
a
summary
of
the
petition
prepared
by
BASF
Corporation,
the
registrant.
There
were
no
comments
received
in
response
to
the
notice
of
filing.
The
petition
requested
that
40
CFR
180.395
be
amended
by
establishing
a
tolerance
for
residues
of
the
insecticide
Hydramethylnon
in
or
on
pineapple
at
0.05
parts
per
million
(
ppm).
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
a
tolerance
for
residues
of
hydramethylnon
on
pineapple
at
0.05
ppm.
EPA's
assessment
of
exposures
and
risks
associated
with
establishing
the
tolerance
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
hydramethylnon
are
discussed
in
Table
1
of
this
unit
as
well
as
the
no­
observed­
adverse­
effectlevel
(
NOAEL)
and
the
lowest­
observedadverse
effect­
level
(
LOAEL)
from
the
toxicity
studies
reviewed.

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Vol.
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No.
156
/
Wednesday,
August
13,
2003
/
Rules
and
Regulations
TABLE
1.
 
SUBCHRONIC,
CHRONIC,
AND
OTHER
TOXICITY
Guideline
No.
Study
Type
Results
870.3100
Subchronic
Feeding
­
Rat
NOAEL
=
2.5
mg/
kg/
day
LOAEL
=
5.0
mg/
kg/
day
­
decreased
testicular
weights
(
34%),
and
testicular
atrophy.

870.3150
Subchronic
Gavage
­
Dog
NOAEL
=
3
mg/
kg/
day
­
LDT;
decreased
food
consumption
(
11%/
20%,
males/
females)
and
body
weight
gain
(
11%/
9%,
males/
females).
LOAEL
=
not
defined
Lethal
Dose
=
6
mg/
kg/
day
­
decreased
food
consumption
and
body
weight
gain,
 
SGPT,
cachexia,
wasting
of
muscle
and
subcutaneous
fat,
testicular
atrophy,
and
death.

870.3150
Subchronic
Gavage
­
Dog
NOAEL
=
1.0
mg/
kg/
day
LOAEL
=
3.0
mg/
kg/
day
­
increased
incidence
of
soft
stools,
mucoid
stools,
and
diarrhea.

870.3200
21
 
Day
Dermal
­
Rabbit
NOAEL
=
250
mg/
kg/
day
(
HDT)
Food
consumption
was
depressed
as
much
as
38%
and
45%
in
the
high­
dose
males
and
females,
compared
to
controls.
The
high­
dose
males
and
females
weighed
as
much
as
8%
and
9%
less
than
the
controls
The
platelet
count
in
the
high­
dose
females
at
termination
was
54%
less
than
controls,
but
was
not
considered
adverse
because
it
is
a
common
finding
following
skin
abrasion.

870.3700
Developmental
Toxicity
­
Rat
Maternal
NOEL
=
3
mg/
kg/
day
Maternal
NOAEL
=
10
mg/
kg/
day
­
8%
decrease
in
body
weight
and
yellowish
discoloration
of
the
fat.
Maternal
LOAEL
=
30
mg/
kg/
day
­
16%
decrease
in
body
weight;
increased
incidence
of
nasal
mucus,
alopecia
soft
stools,
staining
of
the
anogenital
fur,
yellowish
discoloration
of
the
fat,
and
small
thymus.
Developmental
NOEL
=
10
mg/
kg/
day
Developmental
LOAEL
=
30
mg/
kg/
day
­
decreased
mean
fetal
weights
and
increased
incidence
of
rudimentary
structures
and
incompletely
ossified
supraoccipitals.
At
30
mg/
kg/
day,
a
16%
decrease
in
maternal
body
weight,
increased
incidence
of
clinical
signs
(
nasal
mucus,
alopecia,
soft
stool,
staining
of
anogenital
fur),
yellowish
discoloration
of
the
fat,
and
small
thymus
were
observed.

870.3700
Developmental
Toxicity
­
Rabbit
Maternal
NOAEL
=
5
mg/
kg/
day
­
soft
stools,
and
reduced
amount
of
stools.
Maternal
LOAEL
=
10
mg/
kg/
day
­
abortions,
soft
stools,
reduced
amount
of
stools,
and
anogenital
matting
and
discharge.
Developmental
NOAEL
=
5
mg/
kg/
day
­
decreased
fetal
weight
(
8%).
Developmental
LOAEL
=
10
mg/
kg/
day
­
abortions,
decreased
fetal
weight
(
16%).

870.3800
2­
Generation
Reproductive
Toxicity
­
Rat
Reproductive/
Systemic
NOAEL
=
25
ppm
(
1.66/
2.01
mg/
kg/
day,
male/
female)
Reproductive/
Systemic
LOAEL
=
50
ppm
(
3.32
/
4.13
mg/
kg/
day,
male/
female)
(
degeneration
of
the
germinal
epithelium
(
1/
29)
and
aspermia
(
1/
29)

870.4100
Chronic
Feeding
Toxicity
­
Dog
See
870.3150
870.4200
Carcinogenicity
Feeding
­
Mouse
(
18
months)
NOAEL
=
25
ppm
(
3.57
mg/
kg/
day)
in
males
NOAEL
=
not
defined
in
females.
LOAEL
=
50
ppm
(
6.93
mg/
kg/
day)
in
males
(
testicular
lesions)
LOAEL
=
25
ppm
(
4.45
mg/
kg/
day)
in
females
(
LDT;
combined
lung
adenomas
and
carcinomas)
The
high­
dose
females
were
sacrificed
after
5
weeks
due
to
high
mortality.

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Rules
and
Regulations
TABLE
1.
 
SUBCHRONIC,
CHRONIC,
AND
OTHER
TOXICITY
 
Continued
Guideline
No.
Study
Type
Results
870.4300
Chronic
Feeding
Toxicity/
Carcinogenicity­
Rat
NOAEL
=
50
ppm
(
2.4
mg/
kg/
day
in
males,
3.0
mg/
kg/
day
in
females)
LOAEL
=
100
ppm
(
4.9
mg/
kg/
day
in
males,
6.2
mg/
kg/
day
in
females)
(
small,
soft
testes,
decreased
testicular
weights,
and
testicular
atrophy
in
males;
decreased
body
weight
gain
in
females)

870.5100
Bacterial
Reverse
Mutation
Test
(
Ames
Assay)
Negative
870.5375
In
Vitro
Chromosomal
Aberration
in
Chinese
Hamster
Ovary
(
CHO)
Cells
Negative
870.5450
Rodent
Dominant
Lethal
Assay
­
Rat
Negative
870.5575
D4
Mitotic
Gene
Conversion
Assay
Negative
P1
Forward
Gene
Mutation
Assay
Negative
870.7485
Metabolism
­
Rat
The
majority
of
the
administered
dose
of
phenyl­
or
pyrimidinyl­
14C­
Cl
217,300
was
recovered
in
the
feces
(
85
 
98%).
Recovery
in
the
urine
was
minimal
(
1­
to
2%
of
the
administered
dose).
There
were
no
sex
or
dose­
related
differences
in
urinary
or
fecal
elimination.

870.7600
Dermal
Penetration
­
Rat
Sprague­
Dawley
rats
were
dermally
dosed
with
a
gel
formulation
containing
2%
a.
i.
(
Maxforce
Gel
 
)
.
Total
dose
absorbed
after
10
hours
was
0.414%

870.7600
Dermal
Penetration
­
Rat
Sprague­
Dawley
rats
were
dermally
dosed
with
a
gel
formulation
containing
2.16%
a.
i.
(
Siege
 
)
.
Total
dose
absorbed
after
10
hours
was
0.97%

B.
Toxicological
Endpoints
The
dose
at
which
no
adverse
effects
are
observed
(
the
NOAEL)
from
the
toxicology
study
identified
as
appropriate
for
use
in
risk
assessment
is
used
to
estimate
the
toxicological
level
of
concern
(
LOC).
However,
the
lowest
dose
at
which
adverse
effects
of
concern
are
identified
(
the
LOAEL)
is
sometimes
used
for
risk
assessment
if
no
NOAEL
was
achieved
in
the
toxicology
study
selected.
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
intra
species
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
factors
(
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.
The
linear
default
risk
methodology
(
Q*)
is
the
primary
method
currently
used
by
the
Agency
to
quantify
carcinogenic
risk.
The
Q*
approach
assumes
that
any
amount
of
exposure
will
lead
to
some
degree
of
cancer
risk.
A
Q*
is
calculated
and
used
to
estimate
risk
which
represents
a
probability
of
occurrence
of
additional
cancer
cases
(
e.
g.,
risk
is
expressed
as
1
x
10­
6
or
one
in
a
million).
Under
certain
specific
circumstances,
MOE
calculations
will
be
used
for
the
carcinogenic
risk
assessment.
In
this
non­
linear
approach,
a
``
point
of
departure''
is
identified
below
which
carcinogenic
effects
are
not
expected.
The
point
of
departure
is
typically
a
NOAEL
based
on
an
endpoint
related
to
cancer
effects
though
it
may
be
a
different
value
derived
from
the
dose
response
curve.
To
estimate
risk,
a
ratio
of
the
point
of
departure
to
exposure
(
MOEcancer
=
point
of
departure/
exposures)
is
calculated.
A
summary
of
the
toxicological
endpoints
for
hydramethylnon
used
for
human
risk
assessment
is
shown
in
the
following
Table
2:

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Rules
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Regulations
TABLE
2.
 
SUMMARY
OF
TOXICOLOGICAL
DOSE
AND
ENDPOINTS
FOR
HYDRAMETHYLNON
FOR
USE
IN
HUMAN
RISK
ASSESSMENT
Exposure
Scenario
Dose
Used
in
Risk
Assessment,
UF
FQPA
SF*
and
Level
of
Concern
for
Risk
Assessment
Study
and
Toxicological
Effects
Acute
Dietary
(
Females
13
 
50
years
of
age)
NOAEL
=
5
mg/
kg/
day
UF
=
100
Acute
RfD
=
0.05
mg/
kg/
day
FQPA
SF
=
1
aPAD
=
acute
RfD
÷
FQPA
SF
=
0.05
mg/
kg/
day
Developmental
toxicity
in
rabbits
LOAEL
=
10
mg/
kg/
day
based
on
abortions.

Acute
Dietary
(
General
population
including
infants
and
children)
­
­
There
is
no
appropriate
single
dose
endpoint
for
the
general
population.

Chronic
Dietary
(
All
populations
NOAEL=
1.66
mg/
kg/
day
UF
=
100
Chronic
RfD
=
0.017
mg/
kg/
day
FQPA
SF
=
1
cPAD
=
chronic
RfD
÷
FQPA
SF
=
0.017
mg/
kg/
day
2­
Generation
reproductive
toxicity
in
rats
LOAEL
=
3.32
mg/
kg/
day
based
on
testicular
effects.

Short­
Term
Incidental
Oral
(
1
 
30
days)
Oral
NOAEL=
1.66
mg/
kg/
day
LOC
for
MOE
=
100
(
Residential)
2­
Generation
reproductive
toxicity
in
rats
LOAEL
=
3.32
mg/
kg/
day
based
on
testicular
effects.

Intermediate­
Term
Incidental
Oral
(
1
 
6
months)
Oral
NOAEL=
1.66
mg/
kg/
day
LOC
for
MOE
=
100
(
Residential)
2­
Generation
reproductive
toxicity
in
rats
LOAEL
=
3.32
mg/
kg/
day
based
on
testicular
effects.

Short­
Term
Dermal
(
1
to
30
days)(
Residential)
Oral
NOAEL=
1.66
mg/
kg/
day
(
dermal
absorption
rate
=
1%)
LOC
for
MOE
=
100
(
Residential)
2­
Generation
reproductive
toxicity
in
rats
LOAEL
=
3.32
mg/
kg/
day
based
on
testicular
effects.

Intermediate­
Term
Dermal
(
1
week
to
6
months)
(
Residential
Oral
NOAEL
=
1.66
mg/
kg/
day(
dermal
absorption
rate
=
1%)
LOC
for
MOE
=
100
(
Residential)
2­
Generation
reproductive
toxicity
in
rats
LOAEL
=
3.32
mg/
kg/
day
based
on
testicular
effects.

Long­
Term
Dermal
(
several
months
to
lifetime)
(
Residential
Oral
NOAEL=
1.66
mg/
kg/
day
(
dermal
absorption
rate
=
1%)
LOC
for
MOE
=
100
(
Residential)
2­
Generation
reproductive
toxicity
in
rats
LOAEL
=
3.32
mg/
kg/
day
based
on
testicular
effects.

Short­
Term
Inhalation
(
1
to
7
days)
(
Residential)
inhalation
(
or
oral)
study
NOAEL=
1.66
mg/
kg/
day(
inhalation
absorption
rate
=
100%)
LOC
for
MOE
=
100
(
Residential)
2­
Generation
reproductive
toxicity
in
rats
LOAEL
=
3.32
mg/
kg/
day
based
on
testicular
effects.

Intermediate­
Term
Inhalation
(
1
week
to
several
months)
(
Residential)
inhalation
(
or
oral)
study
NOAEL
=
1.66
mg/
kg/
day(
inhalation
absorption
rate
=
100%)
LOC
for
MOE
=
100
(
Residential)
2­
Generation
reproductive
toxicity
in
rats
LOAEL
=
3.32
mg/
kg/
day
based
on
testicular
effects.

Long­
Term
Inhalation
(
several
months
to
lifetime)
(
Residential
inhalation
(
or
oral)
study
NOAEL=
1.66
mg/
kg/
day(
inhalation
absorption
rate
=
100%)
LOC
for
MOE
=
100
(
Residential)
2­
Generation
reproductive
toxicity
in
rats
LOAEL
=
3.32
mg/
kg/
day
based
on
testicular
effects.

Cancer
(
oral,
dermal,
inhalation
The
Agency's
Cancer
Peer
Review
Committee
determined
that
hydramethylnon
should
be
classified
as
a
Group
C­
possible
human
carcinogen,
and
recommended
that,
for
the
purpose
of
risk
characterization,
the
Reference
Dose
approach
should
be
used
for
quantification
of
human
risk.
The
Cancer
Peer
Review
report
was
issued
on
March
28,
1991.
The
Agency's
HIARC
committee
concurred
with
the
cancer
classification
on
March
4,
2003.

*
The
reference
to
the
FQPA
SF
refers
to
any
additional
SF
retained
due
to
concerns
unique
to
the
FQPA.

C.
Exposure
Assessment
1.
Dietary
exposure
from
food
and
feed
uses.
Tolerances
have
been
established
(
40
CFR
180.395)
for
the
residues
of
hydramethylnon,
on
grass
and
grass
hay
for
pasture
and
rangeland
at
0.05
ppm
established
in
terms
of
parent
only,
tetrahydro­
5,5­
dimethyl­
2(
1H)­
pyrimidinone
(
3­(
4­
(
trifluoromethyl)
phenyl)­
1­(
2­(
4­
(
trifluoromethyl)
phenyl)
ethenyl)­
2­
propenylidene)
hydrazone.
The
Agency
determined
that
the
residue
of
concern
in
grasses
and
the
milk,
meat,
and
meat
byproducts
of
ruminants
is
hydramethylnon
per
se,
and
that
there
is
no
reasonable
expectation
of
finite
hydramethylnon
residues
of
concern
in
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and
Regulations
the
milk,
meat,
and
meat
byproducts
of
ruminants
40
CFR
180.6(
a)(
3)
as
a
result
of
hydramethylnon
use
on
grasses.
The
Agency
has
also
previously
recommended
that
the
grass
forage
tolerance
be
increased
to
2.0
ppm
and
the
grass
hay
tolerance
be
increased
to
0.1
ppm.
The
residue
chemistry
and
toxicological
databases
support
the
requested
tolerance
of
0.05
ppm
for
hydramethylnon
on
pineapple.
Since
there
are
no
detectable
hydramethylnon
residues
in
the
pineapple
feed
item,
process
residues,
tolerances
for
hydramethylnon
residues
in
animal
commodities
need
not
be
established.
Risk
assessments
were
conducted
by
EPA
to
assess
dietary
exposures
from
hydramethylnon
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
one
day
or
single
exposure.
An
unrefined,
Tier
1
acute
dietary
exposure
assessment
was
conducted
using
tolerance­
level
residues
and
assuming
100%
crop
treated
(
CT)
for
all
registered
and
proposed
commodities.
The
acute
analysis
was
conducted
for
females
13
 
49
years
old
only
as
no
appropriate
single
dose
endpoint
was
established
for
the
general
U.
S.
population
and
infants
and
children.
The
acute
dietary
exposure
estimates
are
well
below
the
Agency's
level
of
concern
(<
100%
aPAD)
at
the
95th
exposure
percentile
for
females
13
 
49
years
old
(<
1%
of
the
aPAD).
ii.
Chronic
exposure.
In
conducting
this
chronic
dietary
risk
assessment
the
Dietary
Exposure
Evaluation
Model
(
DEEM
 
)
analysis
evaluated
the
individual
food
consumption
as
reported
by
respondents
in
the
USDA
1994
 
1996/
1998
nationwide
Continuing
Surveys
of
Food
Intake
by
Individuals
(
CSFII)
and
accumulated
exposure
to
the
chemical
for
each
commodity.
The
following
assumptions
were
made
for
the
chronic
exposure
assessments:
A
Tier
1
(
conservative,
deterministic
assessment
using
tolerance­
level
residues,
and
100%
crop
treated
(
CT)
for
the
proposed
commodity;
and
DEEMFCID
 
ver.
1.30,
processing
factors
set
to
(
1)
a
chronic
dietary
exposure
assessment
was
conducted
for
the
general
U.
S.
population
and
various
population
subgroups.
The
chronic
dietary
exposure
estimates
are
well
below
the
Agency's
level
of
concern
(<
100%
cPAD)
for
the
general
U.
S.
population
(<
1%
of
the
cPAD)
and
all
population
subgroups.
iii.
Cancer.
In
a
chronic
feeding/
carcinogenicity
study
in
Charles
River
CD
rats,
no
compound­
related
clinical
signs
were
observed
and
survival
was
not
affected
by
treatment.
The
LOAEL
was
based
on
small,
soft
testes,
decreased
testicular
weights
(
27%),
and
testicular
atrophy
in
males;
and
decreased
body
weight
gain
in
females
(
22%).
Statistically
significant
findings
of
neoplasia
were
found
in
the
uterus
(
adenomatous
polyps)
and
adrenals
(
medullary
adenomas),
but
these
were
not
considered
toxicologically
significant
because
they
were
seen
at
doses
above
the
MTD.
In
an
18
month
carcinogenicity
feeding
study
in
Charles
River
CD­
1
mice,
survival
decreased
as
the
dose
increased,
but
not
enough
to
jeopardize
the
study.
The
LOAEL
was
based
on
testicular
degeneration
(
hypospermia,
interstitial
cell
hyperplasia
of
Leydig
cells,
and
germinal
cell
degeneration)
in
males,
and
combined
lung
adenomas
and
carcinomas
in
females.
Findings
of
hyperplasia
and
neoplasia
in
the
lungs
of
males
were
not
considered
toxicologically
significant
because
they
were
seen
at
doses
above
the
MTD.
Findings
in
females
of
statistically
significant
increases
in
lung
adenomas
and
combined
lung
adenomas/
carcinomas
were,
however,
considered
toxicologically
significant.
The
Agency's
Cancer
Peer
Review
Committee
classified
hydramethylnon
as
a
Group
C­
possible
human
carcinogen,
and
recommended
that,
for
the
purpose
of
risk
characterization,
the
Reference
Dose
approach
should
be
used
for
quantification
of
human
risk.
This
classification
was
based
upon
statistically
significant
increases
in
lung
adenomas
and
combined
lung
adenomas/
carcinomas
in
female
mice.
Dietary
risk
concerns
due
to
long­
term
consumption
of
hydramethylnon
residues
are
adequately
addressed
by
the
chronic
exposure
analysis
using
the
RfD.
iv.
Anticipated
residue
and
percent
crop
treated
(
PCT)
information.
Section
408(
b)(
2)(
F)
of
the
FFDCA
states
that
the
Agency
may
use
data
on
the
actual
percent
of
food
treated
for
assessing
chronic
dietary
risk
only
if
the
Agency
can
make
the
following
findings:
Condition
1,
that
the
data
used
are
reliable
and
provide
a
valid
basis
to
show
what
percentage
of
the
food
derived
from
such
crop
is
likely
to
contain
such
pesticide
residue;
Condition
2,
that
the
exposure
estimate
does
not
underestimate
exposure
for
any
significant
subpopulation
group;
and
Condition
3,
if
data
are
available
on
pesticide
use
and
food
consumption
in
a
particular
area,
the
exposure
estimate
does
not
understate
exposure
for
the
population
in
such
area.
In
addition,
the
Agency
must
provide
for
periodic
evaluation
of
any
estimates
used.
To
provide
for
the
periodic
evaluation
of
the
estimate
of
PCT
as
required
by
section
408(
b)(
2)(
F)
of
the
FFDCA,
EPA
may
require
registrants
to
submit
data
on
PCT.
A
routine
chronic
dietary
exposure
analysis
for
pineapple
was
based
on
100%
of
pineapple
crop
treated,
and
100%
of
grasses,
forage
(
pasture
and
rangeland)
treated
with
hydramethylnon.
The
Agency
believes
that
the
three
conditions
previously
discussed
have
been
met.
With
respect
to
Condition
1,
EPA
used
a
conservative,
model
assessment
as
outlined
in
Unit
III.
C.
1.
ii.
above,
using
tolerance­
level
residues
and
100%
CT
for
the
proposed
commodity
pineapple,
and
existing
commodities.
As
to
Conditions
2
and
3,
regional
consumption
information
and
consumption
information
for
significant
subpopulations
is
taken
into
account
through
EPA's
computer­
based
model
for
evaluating
the
exposure
of
significant
subpopulations
including
several
regional
groups.
Use
of
this
consumption
information
in
EPA's
risk
assessment
process
ensures
that
EPA's
exposure
estimate
does
not
understate
exposure
for
any
significant
subpopulation
group
and
allows
the
Agency
to
be
reasonably
certain
that
no
regional
population
is
exposed
to
residue
levels
higher
than
those
estimated
by
the
Agency.
Other
than
the
data
available
through
national
food
consumption
surveys,
EPA
does
not
have
available
information
on
the
regional
consumption
of
food
to
which
hydramethylnon
may
be
applied
in
a
particular
area.
2.
Dietary
exposure
from
drinking
water.
The
Agency
lacks
sufficient
monitoring
exposure
data
to
complete
a
comprehensive
dietary
exposure
analysis
and
risk
assessment
for
hydramethylnon
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
use
pattern,
physical
characteristics
and
environmental
fate
of
hydramethylnon.
The
Agency
uses
the
FQPA
Index
Reservoir
Screening
Tool
(
FIRST)
or
the
Pesticide
Root
Zone
Model/
Exposure
Analysis
Modeling
System
(
PRZM/
EXAMS),
to
produce
estimates
of
pesticide
concentrations
in
an
index
reservoir.
The
screening
concentation
in
ground
water
(
SCI­
GROW)
model
is
used
to
predict
pesticide
concentrations
in
shallow
groundwater.
For
a
screening­
level
assessment
for
surface
water
EPA
will
use
FIRST
(
a
tier
1
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/
Rules
and
Regulations
model)
before
using
PRZM/
EXAMS
(
a
tier
2
model).
The
FIRST
model
is
a
subset
of
the
PRZM/
EXAMS
model
that
uses
a
specific
high­
end
runoff
scenario
for
pesticides
and
an
index
reservoir
with
the
percent
crop
area
adjustment.
None
of
these
models
include
consideration
of
the
impact
processing
(
mixing,
dilution,
or
treatment)
of
raw
water
for
distribution
as
drinking
water
would
likely
have
on
the
removal
and
transformation
of
pesticides
from
the
source
water.
The
primary
use
of
these
models
by
the
Agency
at
this
stage
is
to
provide
an
initial
screen
for
sorting
out
pesticides
for
which
it
is
highly
unlikely
that
drinking
water
concentrations
would
ever
exceed
human
health
levels
of
concern.
Since
the
models
used
are
considered
to
be
screening
tools
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
percent
of
reference
dose
or
percent
of
population
adusted
dose
(%
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
hydramethylnon
they
are
further
discussed
in
the
aggregate
risk
sections
in
Unit
III.
E.
Based
on
the
FIRST
and
SCI­
GROW
models
the
EECs
of
hydramethylnon
for
acute
exposures
are
estimated
to
be
76.09
parts
per
billion
(
ppb)
for
surface
water
and
0.035
ppb
for
ground
water.
The
EECs
for
chronic
exposures
are
estimated
to
be
1.45
ppb
for
surface
water
and
0.035
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).
Hydramethylnon
is
currently
registered
for
use
on
the
following
residential
non­
dietary
sites:
Hydramethylnon
is
used
as
a
bait
in
child
resistant
packaging
(
CRP)
and
as
a
gel
bait
to
control
ants
and
roaches
indoors,
and
as
a
granular
formulation
to
control
ants
in
yards
and
on
lawns.
It
is
also
applied
by
pest
control
operators
(
PCOs)
in
the
same
forms
for
indoor
and
outdoor
pest
control.
The
risk
assessment
was
conducted
using
the
following
residential
exposure
assumptions:
The
Agency
has
completed
a
non­
dietary
exposure
and
risk
assessment
for
hydramethylnon
including
the
following
uses:
residential
consumers
applying
granular
and
gel
formulations;
children
and
adults
contacting
recreational
turf
or
residential
lawns
treated
with
hydramethylnon;
and
toddlers'
incidental
nondietary
ingestion
of
products
applied
around
the
home.
Non­
occupational
handler
exposures
from
the
granular
formulations
applied
to
outdoor
residential
sites
are
assumed
to
be
short­
term
in
duration,
based
on
rapid
dissipation
and
insect
foraging.
No
chemical­
specific
data
were
submitted
for
the
registration
of
hydramethylnon
uses.
Per
an
Agency
policy,
non­
occupational
handler
assessments
are
based
on
surrogate
unit
exposures
from
the
draft
Standard
Operating
Procedures
(
SOPs)
for
Residential
Exposure
Assessments
(
12/
18/
97)
and
recommended
approaches
by
the
Agency's
Exposure
Science
Advisory
Committee
(
ExpoSAC).
Updates
to
the
Residential
SOPs
(
02/
01)
alter
the
residential
postapplication
scenario
assumptions.
These
updated
assumptions
are
expected
to
better
represent
residential
exposure
and
are
still
considered
to
be
high­
end,
screening
level
assumptions.
The
nonoccupational
handler
assessments
for
push
type
granular
spreaders
were
based
on
surrogate
unit
exposures
from
two
Outdoor
Residential
Exposure
Task
Force
(
ORETF)
studies.
The
ant
bait
stations
containing
hydramethylnon
are
in
child­
resistant
packaging
(
CRP).
The
bait
stations
are
supposed
to
be
placed
in
less
accessible
locations
such
as
in
or
under
kitchen
counters.
However,
handling
or
mouthing
of
the
bait
stations
is
the
most
commonly
reported
incidental
``
exposure''
to
hydramethylnon.
Such
exposures
involve,
at
most,
children
mouthing
the
bait
container
with
little
or
no
contact
with
the
actual
bait.
In
the
absence
of
an
applicable
acute
dietary
endpoint,
and
with
the
vast
majority
of
incident
data
resulting
in
little
or
no
health
effects,
no
quantitative
assessment
of
accidental
exposure
to
the
internal
contents
of
bait
stations
was
conducted.
The
gel
product
containing
hydramethylnon
is
supposed
to
be
applied
in
dime­
sized
portions
in
locations
inaccessible
to
children.
Accidental
ingestion
of
gel
from
such
application
is
considered
unlikely
and
was
therefore
not
assessed.
Adult
consumer
exposures
when
installing
and
removing
bait
stations
are
expected
to
be
minimal.
Consumer
exposure
when
applying
the
gel
compound
from
a
syringe
is
considered
negligible.
Limited
accessibility
(
i.
e.,
crack,
crevice,
behind
appliances,
in
crawl
spaces)
of
the
gel
and
granular
formulations
when
used
by
professional
applicators
in
the
home
make
it
unlikely
that
residents
would
be
exposed
to
these
formulations
indoors.
For
the
proposed
application
of
granules
to
outdoor
residential
sites,
dermal
MOEs
calculated
for
non­
occupational
handlers
were
10,000
or
greater.
Dermal
postapplication
exposure
from
lawns
treated
with
hydramethylnon
granules
at
the
maximum
application
rate
of
2.2
lb
product
per
acre
(
0.022
lb
ai/
A)
were
estimated
using
standard
assumptions,
as
no
chemical­
specific
residue
data
were
available.
For
adults
and
children
playing
actively
for
two
hours
on
a
just­
treated
lawn,
the
estimated
MOEs
were
41,000
and
24,000,
respectively.
The
aggregate
(
dermal,
hand­
mouth
and
object­
mouth)
MOE
for
a
15
kg
child
playing
on
a
lawn
was
4,000.
The
MOE
for
incidental
ingestion
of
3
mg
of
1%
hydramethylnon
granules
found
on
the
surface
of
the
lawn
was
850.
The
hydramethylnon
granules
are
formulated
as
small
granules
to
allow
for
ant
removal,
and
are
therefore
not
easily
noticed
by
a
child,
and
ingestion
is
unlikely.
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
hydramethylnon
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,
hydramethylnon
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
hydramethylnon
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).

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Vol.
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156
/
Wednesday,
August
13,
2003
/
Rules
and
Regulations
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.
The
Agency
has
concluded
that
there
is
no
concern
for
pre­
and/
or
postnatal
toxicity
resulting
from
exposure
to
hydramethylnon.
3.
Conclusion.
There
is
a
complete
toxicity
data
base
for
hydramethylnon
and
exposure
data
are
complete
or
are
estimated
based
on
data
that
reasonably
accounts
for
potential
exposures.
The
Agency
determined
that
no
special
FQPA
Safety
Factor
is
needed
(
1x)
for
hydramethylnon.
The
exposure
databases
(
dietary
food,
drinking
water,
and
residential)
are
complete
and
the
risk
assessment
for
each
potential
exposure
scenario
includes
all
metabolites
and/
or
degradates
of
concern
and
does
not
underestimate
the
potential
risk
for
infants
and
children.
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
body
weights.
Default
body
weights
and
consumption
values
as
used
by
the
USEPA
Office
of
Water
are
used
to
calculate
DWLOCs:
2
liter
(
L)/
70
kg
(
adult
male),
2L/
60
kg
(
adult
female),
and
1L/
10
kg
(
child).
Default
body
weights
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
groundwater
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
EPA
has
reliable
data)
would
not
result
in
unacceptable
levels
of
aggregate
human
health
risk
at
this
time.
Because
EPA
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,
EPA
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.
Using
the
exposure
assumptions
discussed
in
this
unit
for
acute
exposure,
the
acute
dietary
exposure
from
food
to
hydramethylnon
will
occupy
<
1%
of
the
aPAD
for
females
13
years
and
older.
In
addition,
there
is
potential
for
acute
dietary
exposure
to
hydramethylnon
in
drinking
water.
After
calculating
DWLOCs
and
comparing
them
to
the
EECs
for
surface
and
ground
water,
EPA
does
not
expect
the
aggregate
exposure
to
exceed
100%
of
the
aPAD,
as
shown
in
the
following
Table
3:

TABLE
3.
 
AGGREGATE
RISK
ASSESSMENT
FOR
ACUTE
EXPOSURE
TO
HYDRAMETHYLNON.

Population
Subgroup
aPAD
(
mg/
kg)
%
aPAD
(
Food)
Surface
Water
EEC
(
ppb)
Ground
Water
EEC
(
ppb)
Acute
DWLOC
(
ppb)

Females
(
13
 
49
years
old)
0.05
<
1
76.09
0.035
1,500
2.
Chronic
risk.
Using
the
exposure
assumptions
described
in
this
unit
for
chronic
exposure,
EPA
has
concluded
that
exposure
to
hydramethylnon
from
food
will
utilize
<
1%
of
the
cPAD
for
the
U.
S.
population,
and
<
1%
(
0.02%)
of
the
cPAD
for
children
1
 
2
years
old.
Based
on
the
use
pattern,
chronic
residential
exposure
to
residues
of
hydramethylnon
is
not
expected.
In
addition,
there
is
potential
for
chronic
dietary
exposure
to
hydramethylnon
in
drinking
water.
After
calculating
DWLOCs
and
comparing
them
to
the
EECs
for
surface
and
ground
water,
EPA
does
not
expect
the
aggregate
exposure
to
exceed
100%
of
the
cPAD,
as
shown
in
the
following
Table
4:

TABLE
4.
 
AGGREGATE
RISK
ASSESSMENT
FOR
CHRONIC
(
NON­
CANCER)
EXPOSURE
TO
HYDRAMETHYLNON
Population
Subgroup
cPAD
mg/
kg/
day
Chronic
Food
Exposure
(
mg/
kg/
day)
Surface
Water
EEC
(
ppb)
Ground
Water
EEC
(
ppb)
Chronic
DWLOC
(
ppb)

U.
S.
Population
0.017
0.000005
1.45
0.035
600
All
infants
(<
1
year
old)
0.017
0.000012
1.45
0.035
170
Children
(
1
 
2
years
old)
0.017
0.000026
1.45
0.035
170
Children
(
3
 
5
years
old)
0.017
0.000016
1.45
0.035
170
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Rules
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Regulations
TABLE
4.
 
AGGREGATE
RISK
ASSESSMENT
FOR
CHRONIC
(
NON­
CANCER)
EXPOSURE
TO
HYDRAMETHYLNON
 
Continued
Population
Subgroup
cPAD
mg/
kg/
day
Chronic
Food
Exposure
(
mg/
kg/
day)
Surface
Water
EEC
(
ppb)
Ground
Water
EEC
(
ppb)
Chronic
DWLOC
(
ppb)

Children
(
6
 
12
years
old)
0.017
0.000008
1.45
0.035
170
Youth
(
13
 
19
years
old)
0.017
0.000002
1.45
0.035
170
Adults
(
20
 
49
years
old)
0.017
0.000003
1.45
0.035
600
Females
(
13
 
49
years
old)
0.017
0.000004
1.45
0.035
510
Adults
(
50+
years
old)
0.017
0.000002
1.45
0.035
600
3.
Short­
term
risk.
Short­
term
aggregate
exposure
takes
into
account
residential
exposure
plus
chronic
exposure
to
food
and
water
(
considered
to
be
a
background
exposure
level).
Hydramethylnon
is
currently
registered
for
use
that
could
result
in
short­
term
residential
exposure
and
the
Agency
has
determined
that
it
is
appropriate
to
aggregate
chronic
food
and
water
and
short­
term
exposures
for
hydramethylnon.
Using
the
exposure
assumptions
described
in
this
unit
for
short­
term
exposures,
EPA
has
concluded
that
food
and
residential
exposures
aggregated
result
in
aggregate
MOEs
of
exposures
for
both
adults
(
MOE
=
8,000;
handler
and
post­
application)
and
children
(
MOE
=
680;
post­
application).
Therefore,
the
turf­
treatment
exposure
estimates
were
aggregated
with
the
chronic
dietary
(
food)
to
provide
a
worst­
case
estimate
of
short­
term
aggregate
risk
for
the
U.
S.
population
and
children
1
 
2
years
old
(
the
child
population
subgroup
with
the
highest
estimated
average
(
chronic)
dietary
food
exposure).
These
aggregate
MOEs
do
not
exceed
the
Agency's
level
of
concern
for
aggregate
exposure
to
food
and
residential
uses.
In
addition,
short­
term
DWLOCs
were
calculated
and
compared
to
the
EECs
for
chronic
exposure
of
hydramethylnon
in
ground
and
surface
water.
After
calculating
DWLOCs
and
comparing
them
to
the
EECs
for
surface
and
ground
water,
EPA
does
not
expect
short­
term
aggregate
exposure
to
exceed
the
Agency's
level
of
concern,
as
shown
in
the
following
Table
5:

TABLE
5.
 
AGGREGATE
RISK
ASSESSMENT
FOR
SHORT­
TERM
EXPOSURE
TO
HYDRAMETHYLNON
Population
Subgroup
Aggregate
MOE
(
Food
+
Residential
Aggregate
Level
of
Concern
(
LOC)
Surface
Water
EEC
(
ppb)
Ground
Water
EEC
(
ppb)
Short­
Term
DWLOC
(
ppb)

US
Population
7,700
100
76.09
0.035
580
Children
1
 
2
years
old
3,300
100
76.09
0.035
165
4.
Intermediate­
term
risk.
Intermediate­
term
aggregate
exposure
takes
into
account
residential
exposure
plus
chronic
exposure
to
food
and
water
(
considered
to
be
a
background
exposure
level).
Though
residential
exposure
could
occur
with
the
use
of
hydramethylnon,
an
intermediate­
term
aggregate
risk
assessment
was
not
performed
because
it
is
based
on
the
same
toxic
endpoint
and
dose
as
the
short­
term,
and
the
higher
exposure
used
in
the
short­
term
assessment
represents
a
worse
case.
5.
Aggregate
cancer
risk
for
U.
S.
population.
A
separate
cancer
aggregate
risk
assessment
was
not
performed
because
the
Reference
Dose
approach
was
recommended
for
quantification
of
human
risk.
Cancer
risks
are
adequately
addressed
by
the
chronic
aggregate
and
assessment
which
used
the
chronic
reference
dose
(
cRfD).
6.
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
hydramethylnon
residues.

IV.
Other
Considerations
A.
Analytical
Enforcement
Methodology
The
method
presented
by
BASF
Corporation
and
designated
M
2458,
is
the
predecessor
to
method
M
2458.01
for
which
BASF
Corporation
has
submitted
as
an
independent
method
validation.
The
updated
method
corrects
some
typographical
errors
and
clarifies
some
of
the
fractionation
steps.
Adequate
enforcement
methodology
(
example
 
gas
chromatography)
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
No
maximum
residue
limits
for
hydramethylnon
in/
on
pineapple
have
been
established
or
proposed
by
Codex,
Canada,
or
Mexico
for
any
agricultural
commodity;
therefore,
no
compatibility
concerns
exist
with
respect
to
U.
S.
tolerances.

C.
Conditions
The
following
studies
are
required
to
further
characterize
the
environmental
effects
of
hydramethylnon:
Estuarine/
marine
fish
LC50
(
72
 
1),
Estuarine/
marine
invertebrate
EC50
(
72
 
2),
and
Sediment
Toxicity
Testing
(
Harmonized
guidelines
850.1735
and
850.1740).
In
addition,
the
following
studies
are
required
for
any
future
expansion
of
hydramethylnon
uses:
Aquatic
Photodegradation
(
161
 
2),
Aerobic
Aquatic
Metabolism
(
162
 
4),
and
Terrestrial
Field
Dissipation
(
164
 
1).

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Rules
and
Regulations
D.
Recommendation
for
Tolerances
The
residue
chemistry
and
toxicological
databases
support
the
requested
tolerance
of
0.05
ppm
for
hydramethylnon
on
pineapple.
The
Agency
has
also
previously
recommended
that
the
grass
(
pasture
and
rangeland)
tolerance
be
increased
to
2.0
ppm
and
the
grass
hay
(
pasture
and
rangeland)
tolerance
be
increased
to
0.1
ppm
(
Hydramethylnon
RED,
EPA
738
 
R
 
98
 
023,
12/
98).

V.
Conclusion
Therefore,
the
tolerance
is
established
for
residues
of
hydramethylnon,
in
or
on
pineapple
at
0.05
ppm.,
and
revised
for
grass
(
pasture
and
rangeland)
at
2.0
ppm,
and
grass
hay
(
pasture
and
rangeland)
at
0.1
ppm
respectively.

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
 
0251
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
October
14,
2003.
1.
Filing
the
request.
Your
objection
must
specify
the
specific
provisions
in
the
regulation
that
you
object
to,
and
the
grounds
for
the
objections
(
40
CFR
178.25).
If
a
hearing
is
requested,
the
objections
must
include
a
statement
of
the
factual
issues(
s)
on
which
a
hearing
is
requested,
the
requestor's
contentions
on
such
issues,
and
a
summary
of
any
evidence
relied
upon
by
the
objector
(
40
CFR
178.27).
Information
submitted
in
connection
with
an
objection
or
hearing
request
may
be
claimed
confidential
by
marking
any
part
or
all
of
that
information
as
CBI.
Information
so
marked
will
not
be
disclosed
except
in
accordance
with
procedures
set
forth
in
40
CFR
part
2.
A
copy
of
the
information
that
does
not
contain
CBI
must
be
submitted
for
inclusion
in
the
public
record.
Information
not
marked
confidential
may
be
disclosed
publicly
by
EPA
without
prior
notice.
Mail
your
written
request
to:
Office
of
the
Hearing
Clerk
(
1900C),
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460
 
0001.
You
may
also
deliver
your
request
to
the
Office
of
the
Hearing
Clerk
in
Rm.
104,
Crystal
Mall
#
2,
1921
Jefferson
Davis
Hwy.,
Arlington,
VA.
The
Office
of
the
Hearing
Clerk
is
open
from
8
a.
m.
to
4
p.
m.,
Monday
through
Friday,
excluding
legal
holidays.
The
telephone
number
for
the
Office
of
the
Hearing
Clerk
is
(
703)
603
 
0061.
2.
Tolerance
fee
payment.
If
you
file
an
objection
or
request
a
hearing,
you
must
also
pay
the
fee
prescribed
by
40
CFR
180.33(
i)
or
request
a
waiver
of
that
fee
pursuant
to
40
CFR
180.33(
m).
You
must
mail
the
fee
to:
EPA
Headquarters
Accounting
Operations
Branch,
Office
of
Pesticide
Programs,
P.
O.
Box
360277M,
Pittsburgh,
PA
15251.
Please
identify
the
fee
submission
by
labeling
it
``
Tolerance
Petition
Fees.''
EPA
is
authorized
to
waive
any
fee
requirement
``
when
in
the
judgement
of
the
Administrator
such
a
waiver
or
refund
is
equitable
and
not
contrary
to
the
purpose
of
this
subsection.''
For
additional
information
regarding
the
waiver
of
these
fees,
you
may
contact
James
Tompkins
by
phone
at
(
703)
305
 
5697,
by
e­
mail
at
tompkins.
jim@
epa.
gov,
or
by
mailing
a
request
for
information
to
Mr.
Tompkins
at
Registration
Division
(
7505C),
Office
of
Pesticide
Programs,
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460
 
0001.
If
you
would
like
to
request
a
waiver
of
the
tolerance
objection
fees,
you
must
mail
your
request
for
such
a
waiver
to:
James
Hollins,
Information
Resources
and
Services
Division
(
7502C),
Office
of
Pesticide
Programs,
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460
 
0001.
3.
Copies
for
the
Docket.
In
addition
to
filing
an
objection
or
hearing
request
with
the
Hearing
Clerk
as
described
in
Unit
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
 
0251,
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
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Federal
Register
/
Vol.
68,
No.
156
/
Wednesday,
August
13,
2003
/
Rules
and
Regulations
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
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:
July
31,
2003.
Debra
Edwards,
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
180.395
is
amended
by
adding
alphabetically
the
commodity
``
pineapple''
to
the
table
in
paragraph
(
a)
to
read
as
follows:
§
180.395
Hydramethylnon;
tolerances
for
residues.

(
a)
*
*
*

Commodity
Parts
per
million
*
*
*
*
*
Pineapple
..............................
0.05
*
*
*
*
*

[
FR
Doc.
03
 
20432
Filed
8
 
12
 
03;
8:
45
am]

BILLING
CODE
6560
 
50
 
S
ENVIRONMENTAL
PROTECTION
AGENCY
40
CFR
Part
180
[
OPP
 
2003
 
0134;
FRL
 
7320
 
5]

Diallyl
Sulfides;
Exemption
from
the
Requirement
of
a
Tolerance;
Correction
AGENCY:
Environmental
Protection
Agency
(
EPA).
ACTION:
Final
rule;
correction.

SUMMARY:
EPA
issued
a
final
rule
in
the
Federal
Register
of
July
9,
2003,
establishing
an
exemption
from
the
requirement
of
a
tolerance
for
residues
of
diallyl
sulfides
(
DADs)
in/
or
garlic,
leeks,
onions,
and
shallots.
This
document
corrects
a
typographical
error
in
the
preamble
that
appeared
in
that
document.

DATES:
This
document
is
effective
on
August
13,
2003.

FOR
FURTHER
INFORMATION
CONTACT:
Driss
Benmhend,
Biopesticides
and
Pollution
Prevention
Division
(
7511C),
Office
of
Pesticide
Programs,
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460
 
0001;
telephone
number:
(
703)
308
 
9525;
e­
mail
address:
benmhend@
epa.
gov.

SUPPLEMENTARY
INFORMATION:

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

The
Agency
included
in
the
final
rule
a
list
of
those
who
may
be
potentially
affected
by
this
action.
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
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
 
0134.
The
official
public
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