Document ID: EPA-HQ-OPP-2003-0207-0001
Agency: epa
Document Type: Rule
Title: Spinosad; Pesticide Tolerances for Emergency Exemptions
Posted Date: 2003-08-06T04:00Z

46491
Federal
Register
/
Vol.
68,
No.
151
/
Wednesday,
August
6,
2003
/
Rules
and
Regulations
instructions
for
submitting
comments.
The
system
is
an
``
anonymous
access''
system,
which
means
EPA
will
not
know
your
identity,
e­
mail
address,
or
other
contact
information
unless
you
provide
it
in
the
body
of
your
comment.
2.
By
Mail.
Written
comments
should
be
sent
to
the
name
and
address
listed
in
the
ADDRESSES
section
of
this
document.

Statutory
and
Executive
Order
Reviews
Under
Executive
Order
12866
(
58
FR
51735,
October
4,
1993),
this
action
is
not
a
``
significant
regulatory
action''
and
therefore
is
not
subject
to
review
by
the
Office
of
Management
and
Budget.
For
this
reason,
this
action
is
also
not
subject
to
Executive
Order
13211,
``
Actions
Concerning
Regulations
That
Significantly
Affect
Energy
Supply,
Distribution,
or
Use''
(
66
FR
28355,
May
22,
2001).
This
action
merely
approves
state
law
as
meeting
Federal
requirements
and
imposes
no
additional
requirements
beyond
those
imposed
by
state
law.
Accordingly,
the
Administrator
certifies
that
this
rule
will
not
have
a
significant
economic
impact
on
a
substantial
number
of
small
entities
under
the
Regulatory
Flexibility
Act
(
5
U.
S.
C.
601
et
seq.).
Because
this
rule
approves
pre­
existing
requirements
under
state
law
and
does
not
impose
any
additional
enforceable
duty
beyond
that
required
by
state
law,
it
does
not
contain
any
unfunded
mandate
or
significantly
or
uniquely
affect
small
governments,
as
described
in
the
Unfunded
Mandates
Reform
Act
of
1995
(
Public
Law
104
 
4).
This
rule
also
does
not
have
tribal
implications
because
it
will
not
have
a
substantial
direct
effect
on
one
or
more
Indian
tribes,
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
by
Executive
Order
13175
(
65
FR
67249,
November
9,
2000).
This
action
also
does
not
have
Federalism
implications
because
it
does
not
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,
as
specified
in
Executive
Order
13132
(
64
FR
43255,
August
10,
1999).
This
action
merely
approves
a
state
rule
implementing
a
Federal
standard,
and
does
not
alter
the
relationship
or
the
distribution
of
power
and
responsibilities
established
in
the
CAA.
This
rule
also
is
not
subject
to
Executive
Order
13045,
``
Protection
of
Children
from
Environmental
Health
Risks
and
Safety
Risks''
(
62
FR
19885,
April
23,
1997),
because
it
is
not
economically
significant.
In
reviewing
state
operating
permits
programs
submitted
pursuant
to
Title
V
of
the
CAA,
EPA
will
approve
state
programs
provided
that
they
meet
the
requirements
of
the
CAA
and
EPA's
regulations
codified
at
40
CFR
part
70.
In
this
context,
in
the
absence
of
a
prior
existing
requirement
for
the
state
to
use
voluntary
consensus
standards
(
VCS),
EPA
has
no
authority
to
disapprove
a
state
operating
permits
program
for
failure
to
use
VCS.
It
would
thus
be
inconsistent
with
applicable
law
for
EPA,
when
it
reviews
an
operating
permit
program
submission,
to
use
VCS
in
place
of
a
state
program
that
otherwise
satisfies
the
provisions
of
the
CAA.
Thus,
the
requirements
of
section
12(
d)
of
the
National
Technology
Transfer
and
Advancement
Act
of
1995
(
15
U.
S.
C.
272
note)
do
not
apply.
This
rule
does
not
impose
an
information
collection
burden
under
the
provisions
of
the
Paperwork
Reduction
Act
of
1995
(
44
U.
S.
C.
3501
et
seq.).
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
the
rule
in
the
Federal
Register.
A
major
rule
cannot
take
effect
until
60
days
after
it
is
published
in
the
Federal
Register.
This
action
is
not
a
``
major
rule''
as
defined
by
5
U.
S.
C.
804(
2).
Under
section
307(
b)(
1)
of
the
CAA,
petitions
for
judicial
review
of
this
action
must
be
filed
in
the
United
States
Court
of
Appeals
for
the
appropriate
circuit
by
October
6,
2003.
Filing
a
petition
for
reconsideration
by
the
Administrator
of
this
final
rule
does
not
affect
the
finality
of
this
rule
for
the
purposes
of
judicial
review
nor
does
it
extend
the
time
within
which
a
petition
for
judicial
review
may
be
filed,
and
shall
not
postpone
the
effectiveness
of
such
rule
or
action.
This
action
may
not
be
challenged
later
in
proceedings
to
enforce
its
requirements.
(
See
section
307(
b)(
2).)

List
of
Subjects
40
CFR
Part
70
Environmental
Protection,
Administrative
practice
and
procedure,
Air
pollution
control,
Intergovernmental
relations,
Operating
permits,
Reporting
and
recordkeeping
requirements.

Dated:
July
28,
2003.
William
Rice,
Acting
Regional
Administrator,
Region
7.


40
CFR
part
70
is
amended
as
follows:

PART
70
 
[
AMENDED]


1.
The
authority
citation
for
part
70
continues
to
read
as
follows:

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


2.
Appendix
A
to
part
70
is
amended
by
adding
paragraph
(
b)
under
Kansas
to
read
as
follows:

Appendix
A
to
Part
70
 
Approval
Status
of
State
and
Local
Operating
Permits
Programs
*
*
*
*
*

Kansas
*
*
*
*
*
(
b)
The
Kansas
Department
of
Health
and
the
Environment
approved
revisions
to
the
Kansas
Administrative
Record
(
K.
A.
R.),
28
 
19
 
202
and
28
 
19
 
517,
which
became
effective
on
March
23,
2001,
and
February
28,
1998,
respectively.
These
revisions
were
submitted
on
June
25,
2001.
We
are
approving
these
program
revisions
effective
October
6,
2003.

*
*
*
*
*

[
FR
Doc.
03
 
20019
Filed
8
 
5
 
03;
8:
45
am]

BILLING
CODE
6560
 
50
 
P
ENVIRONMENTAL
PROTECTION
AGENCY
40
CFR
Part
180
[
OPP
 
2003
 
0207;
FRL
 
7317
 
3]

Spinosad;
Pesticide
Tolerances
for
Emergency
Exemptions
AGENCY:
Environmental
Protection
Agency
(
EPA).
ACTION:
Final
rule.

SUMMARY:
This
regulation
establishes
a
time­
limited
tolerance
for
residues
of
spinosad
in
or
on
onion,
dry
bulb.
This
action
is
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
the
pesticide
on
onion,
dry
bulb.
This
regulation
establishes
a
maximum
permissible
level
for
residues
of
spinosad
in
this
food
commodity.
The
tolerance
will
expire
and
is
revoked
on
December
31,
2006.
DATES:
This
regulation
is
effective
August
6,
2003.
Objections
and
requests
for
hearings,
identified
by
docket
ID
number
OPP
 
2003
 
0207,
must
be
received
on
or
before
October
6,
2003.

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46492
Federal
Register
/
Vol.
68,
No.
151
/
Wednesday,
August
6,
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
VII.
of
the
SUPPLEMENTARY
INFORMATION.
FOR
FURTHER
INFORMATION
CONTACT:
Andrew
Ertman,
Registration
Division
(
7505C),
Office
of
Pesticide
Programs,
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460
 
0001;
telephone
number:
(
703)
308
 
9367;
e­
mail
address:
Sec­
18­
Mailbox@
epamail.
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
a
Federal
or
State
Government
Agency
involved
in
Administration
of
Environmental
quality
programs
(
i.
e.,
Departments
of
Agriculture,
Environment,
etc).
Potentially
affected
entities
may
include,
but
are
not
limited
to:
 
Federal
or
State
Government
Entity,
(
NAICS
9241),
i.
e.,
Departments
of
Agriculture,
Environment,
etc.
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
 
0207.
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.
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
EPA,
on
its
own
initiative,
in
accordance
with
sections
408(
e)
and
408(
l)(
6)
of
the
Federal
Food,
Drug,
and
Cosmetic
Act
(
FFDCA),
21
U.
S.
C.
346a,
is
establishing
a
tolerance
for
residues
of
the
insecticide
spinosad,
in
or
on
onion,
dry
bulb
at
0.10
parts
per
million
(
ppm).
This
tolerance
will
expire
and
is
revoked
on
December
31,
2006.
EPA
will
publish
a
document
in
the
Federal
Register
to
remove
the
revoked
tolerance
from
the
Code
of
Federal
Regulations.
Section
408(
l)(
6)
of
the
FFDCA
requires
EPA
to
establish
a
time­
limited
tolerance
or
exemption
from
the
requirement
for
a
tolerance
for
pesticide
chemical
residues
in
food
that
will
result
from
the
use
of
a
pesticide
under
an
emergency
exemption
granted
by
EPA
under
section
18
of
FIFRA.
Such
tolerances
can
be
established
without
providing
notice
or
period
for
public
comment.
EPA
does
not
intend
for
its
actions
on
section
18
related
tolerances
to
set
binding
precedents
for
the
application
of
section
408
of
the
FFDCA
and
the
new
safety
standard
to
other
tolerances
and
exemptions.
Section
408(
e)
of
the
FFDCA
allows
EPA
to
establish
a
tolerance
or
an
exemption
from
the
requirement
of
a
tolerance
on
its
own
initiative,
i.
e.,
without
having
received
any
petition
from
an
outside
party.
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.
.
.
.''
Section
18
of
the
FIFRA
authorizes
EPA
to
exempt
any
Federal
or
State
Agency
from
any
provision
of
FIFRA,
if
EPA
determines
that
``
emergency
conditions
exist
which
require
such
exemption.''
This
provision
was
not
amended
by
the
Food
Quality
Protection
Act
(
FQPA)
of
1996.
EPA
has
established
regulations
governing
such
emergency
exemptions
in
40
CFR
part
166.

III.
Emergency
Exemption
for
Spinosad
on
Onion,
Dry
Bulb
and
FFDCA
Tolerances
The
State
of
New
Mexico
requested
the
use
of
spinosad
to
control
thrips
on
onion,
dry
bulb
due
to
documented
resistance
of
thrips
to
pyrethroid
insecticides.
EPA
has
authorized
under
FIFRA
section
18
the
use
of
spinosad
on
onion
for
control
of
thrips
in
New
Mexico.
After
having
reviewed
the
submission,
EPA
concurs
that
emergency
conditions
exist
for
this
State.
As
part
of
its
assessment
of
this
emergency
exemption,
EPA
assessed
the
potential
risks
presented
by
residues
of
spinosad
in
or
on
onions.
In
doing
so,
EPA
considered
the
safety
standard
in
section
408(
b)(
2)
of
the
FFDCA,
and
EPA
decided
that
the
necessary
tolerance
under
section
408(
l)(
6)
of
the
FFDCA
would
be
consistent
with
the
safety
standard
and
with
FIFRA
section
18.
Consistent
with
the
need
to
move
quickly
on
the
emergency
exemption
in
order
to
address
an
urgent
non­
routine
situation
and
to
ensure
that
the
resulting
food
is
safe
and
lawful,
EPA
is
issuing
this
tolerance
without
notice
and
opportunity
for
public
comment
as
provided
in
section
408(
l)(
6)
of
the
FFDCA.
Although
this
tolerance
will
expire
and
is
revoked
on
December
31,

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and
Regulations
2006,
under
section
408(
l)(
5)
of
the
FFDCA,
residues
of
the
pesticide
not
in
excess
of
the
amounts
specified
in
the
tolerance
remaining
in
or
on
onions
after
that
date
will
not
be
unlawful,
provided
the
pesticide
is
applied
in
a
manner
that
was
lawful
under
FIFRA,
and
the
residues
do
not
exceed
a
level
that
was
authorized
by
this
tolerance
at
the
time
of
that
application.
EPA
will
take
action
to
revoke
this
tolerance
earlier
if
any
experience
with,
scientific
data
on,
or
other
relevant
information
on
this
pesticide
indicate
that
the
residues
are
not
safe.
Because
this
tolerance
is
being
approved
under
emergency
conditions,
EPA
has
not
made
any
decisions
about
whether
spinosad
meets
EPA's
registration
requirements
for
use
on
onions
or
whether
a
permanent
tolerance
for
this
use
would
be
appropriate.
Under
these
circumstances,
EPA
does
not
believe
that
this
tolerance
serves
as
a
basis
for
registration
of
spinosad
by
a
State
for
special
local
needs
under
FIFRA
section
24(
c).
Nor
does
this
tolerance
serve
as
the
basis
for
any
State
other
than
New
Mexico
to
use
this
pesticide
on
this
crop
under
section
18
of
FIFRA
without
following
all
provisions
of
EPA's
regulations
implementing
FIFRA
section
18
as
identified
in
40
CFR
part
166.
For
additional
information
regarding
the
emergency
exemption
for
spinosad,
contact
the
Agency's
Registration
Division
at
the
address
provided
under
FOR
FURTHER
INFORMATION
CONTACT.

IV.
Aggregate
Risk
Assessment
and
Determination
of
Safety
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
November
26,
1997
(
62
FR
62961)
(
FRL
 
5754
 
7).
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
spinosad
and
to
make
a
determination
on
aggregate
exposure,
consistent
with
section
408(
b)(
2)
of
the
FFDCA,
for
a
time­
limited
tolerance
for
residues
of
spinosad
in
or
on
onions
at
0.10
ppm.
EPA's
assessment
of
the
dietary
exposures
and
risks
associated
with
establishing
the
tolerance
follows.

A.
Toxicological
Endpoints
The
dose
at
which
no
observed
adverse
effect
level
are
observed
(
the
NOAEL)
from
the
toxicology
study
identified
as
appropriate
for
use
in
risk
assessment
is
used
to
estimate
the
toxicological
endpoint.
However,
the
lowest
dose
at
which
observed
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
intraspecies
differences.
For
dietary
risk
assessment
(
other
than
cancer)
the
Agency
uses
the
UF
to
calculate
an
acute
or
chronic
reference
dose
(
aRfD
or
cRfD)
where
the
RfD
is
equal
to
the
NOAEL
divided
by
the
appropriate
UF
(
RfD
=
NOAEL/
UF).
Where
an
additional
safety
factor
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
level
of
concern
(
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
spinosad
used
for
human
risk
assessment
is
shown
in
the
following
Table
1:

TABLE
1.
 
SUMMARY
OF
TOXICOLOGICAL
DOSE
AND
ENDPOINTS
FOR
SPINOSAD
USE
IN
HUMAN
RISK
ASSESSMENT
Exposure
Scenario
Dose
Used
in
Risk
Assessment
UF
FQPA
SF*
and
LOC
for
Risk
Assessment
Study
and
Toxicological
Effects
Acute
dietary
females
(
13
 
50
years
of
age)
N/
A
N/
A
This
risk
assessment
is
not
required.
No
endpoint
of
concern
attributable
to
a
single
exposure
was
identified.

Acute
dietary
general
population
including
infants
and
children
N/
A
N/
A
This
risk
assessment
is
not
required.
No
endpoint
attributable
to
a
single
exposure
of
concern
was
identified
for
the
general
population,
including
infants
and
children.

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Vol.
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No.
151
/
Wednesday,
August
6,
2003
/
Rules
and
Regulations
TABLE
1.
 
SUMMARY
OF
TOXICOLOGICAL
DOSE
AND
ENDPOINTS
FOR
SPINOSAD
USE
IN
HUMAN
RISK
ASSESSMENT
 
Continued
Exposure
Scenario
Dose
Used
in
Risk
Assessment
UF
FQPA
SF*
and
LOC
for
Risk
Assessment
Study
and
Toxicological
Effects
Chronic
dietary
all
populations
NOAEL
=
2.68
milligrams
kilogram/
day
(
mg/
kg/
day)
UF
=
100
Chronic
RfD
=
0.02
mg/
kg/
day
FQPA
SF
=
1x
cPAD
=
chronic
RfD
÷
FQPA
SF
=
0.027
mg/
kg/
day
Chronic
toxicity
­
dog
LOAEL
=
8.22
mg/
kg/
day
based
on
on
vacuolation
in
glandular
cells
(
parathyroid
and
lymphatic
tissues,
arteritis
and
increases
in
serum
enzymes
such
as
alanine
aminotransferase,
and
aspartate
aminotransferase,
and
triglyceride
levels.

Incidental
oral
Short­
term
(
1
 
30
days)
Residential
only
NOAEL
=
4.9
mg/
kg/
day
MOE
=
100
FQPA
SF
=
1x
Subchronic
feeding
study
in
dogs
LOAEL
=
9.73
mg/
kg/
day
based
on
microscopic
changes
in
multiple
organs,
clinical
signs
of
toxicity,
decreases
in
mean
body
weights
and
food
consumption
and
biochemical
evidence
of
anemia
and
possible
liver
damage.

Incidental
oral
Intermediate­
term
(
1
 
6
months)
Residential
only
NOAEL
=
2.7
mg/
kg/
day
MOE
=
100
FQPA
SF
=
1x
Chronic
toxicity
study
in
dogs
LOAEL
=
8.22
mg/
kg/
day
based
on
vacuolation
in
glandular
cells
(
parathyroid
and
lymphatic
tissues,
arteritis,
and
increases
in
serum
alanine
aminotransferase,
aspartate
aminotransferase,
and
triglyceride
levels

Dermal
(
any
time
period)
(
Residential)
N/
A
N/
A
Dermal
risk
assessment
is
not
required.
Short­
term,
intermediate­
term,
and
long­
term
dermal
risk
assessments
are
not
required
because:
(
1)
Lack
of
concern
for
prenatal
and/
or
postnatal
toxicity
(
2)
the
combination
of
molecular
structure
and
size
as
well
as
the
lack
of
dermal
or
systemic
toxicity
at
1,000
mg/
kg/
day
in
a
21
 
day
dermal
toxicity
study
in
rats
which
indicates
poor
dermal
absorption;
and
(
3)
the
lack
of
long­
term
exposure
based
on
the
current
use
pattern.

Short­
term
inhalation
(
1
 
30
days)
(
Residential)
Oral
NOAEL
=
4.9
mg/
kg/
day
UF
=
100
FQPA
SF
=
1x
MOE
=
100
Subchronic
feeding
study
in
dogs
LOAEL
=
9.73
mg/
kg/
day
based
on
microscopic
changes
in
a
multiple
organs,
clinical
signs
of
toxicity,
decreases
in
mean
body
weights
and
food
consumption
and
biochemical
evidence
of
anemia
and
possible
liver
damage.

Intermediate­
term
inhalation
(
1
 
6
months)
(
Residential)
Oral
NOAEL
=
2.7
mg/
kg/
day
UF
=
100
FQPA
SF
=
1x
MOE
=
100
Chronic
toxicity
study
in
dogs
LOAEL
=
8.22
mg/
kg/
day
based
on
vacuolation
in
glandular
cells
(
parathyroid
and
lymphatic
tissues,
arteritis,
and
increases
in
serum
alanine
aminotransferase,
aspartate
aminotransferase,
and
triglycerides
levels
Long­
term
inhalation
(>
6
months)
(
Residential)
Oral
NOAEL
=
2.7
mg/
kg/
day
UF
=
100
FQPA
SF
=
1x
MOE
=
100
Chronic
toxicity
study
in
dogs
LOAEL
=
8.22
mg/
kg/
day
based
on
vacuolation
in
glandular
cells
(
parathyroid
and
lymphatic
tissues,
arteritis,
and
increases
in
serum
alanine
aminotransferase,
aspartate
aminotransferase,
and
triglycerides
levels
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/
Vol.
68,
No.
151
/
Wednesday,
August
6,
2003
/
Rules
and
Regulations
TABLE
1.
 
SUMMARY
OF
TOXICOLOGICAL
DOSE
AND
ENDPOINTS
FOR
SPINOSAD
USE
IN
HUMAN
RISK
ASSESSMENT
 
Continued
Exposure
Scenario
Dose
Used
in
Risk
Assessment
UF
FQPA
SF*
and
LOC
for
Risk
Assessment
Study
and
Toxicological
Effects
Cancer
(
oral,
dermal,
inhalation
N/
A
N/
A
Classification:
Not
likely
to
be
carcinogenic
to
humans
Q1*
=
N/
A
Risk
Assessment
not
required.

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

B.
Exposure
Assessment
1.
Dietary
exposure
from
food
and
feed
uses.
Tolerances
have
been
established
(
40
CFR
180.495)
for
the
residues
of
spinosad,
in
or
on
a
variety
of
raw
agricultural
commodities.
Tolerances
range
from
0.02
ppm
(
many
commodities;
limit
of
quantitation)
to
20
ppm
(
aspirated
grain
fractions).
Risk
assessments
were
conducted
by
EPA
to
assess
dietary
exposures
from
spinosad
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
acute
dietary
exposure
risk
assessment
is
not
required
because
the
Agency
did
not
identify
an
acute
dietary
endpoint
that
was
applicable
to
females
(
13+
years)
or
to
the
general
population,
including
infants
and
children.
ii.
Chronic
exposure.
In
conducting
this
chronic
dietary
risk
assessment
the
Dietary
Exposure
Evaluation
Model
(
DEEMTM)
analysis
evaluated
the
individual
food
consumption
as
reported
by
respondents
in
the
U.
S.
Department
of
Agriculture
(
USDA)
1989
 
1992
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:
The
chronic
dietary
(
food
only)
analysis
represents
a
moderately
refined
estimate
of
dietary
exposure
to
spinosad
due
to
the
use
of
default
processing
factors,
percent
crop
treated
(
PCT)
estimates
for
agricultural
crops
having
previously
registered
uses,
and
anticipated
residues
for
meat
and
milk.
This
Tier
3
DEEMTM
analysis
shows
that
dietary
(
food
only)
exposure
estimates
are
below
the
Agency's
LOC
for
all
population
subgroups.
The
highest
chronic
dietary
exposure
was
for
children
1
 
6
years
old
at
0.018540
mg/
kg/
day,
representing
69%
of
the
cPAD.
Exposure
for
the
U.
S.
population
was
0.008127
mg/
kg/
day,
representing
30%
of
the
cPAD.
iii.
Cancer.
Spinosad
has
been
classified
by
the
Agency
as
a
not
likely
human
carcinogen.
Therefore,
a
cancer
dietary
exposure
analysis
was
not
performed.
iv.
Anticipated
residue
and
PCT
information.
Section
408(
b)(
2)(
E)
of
the
FFDCA
authorizes
EPA
to
use
available
data
and
information
on
the
anticipated
residue
levels
of
pesticide
residues
in
food
and
the
actual
levels
of
pesticide
chemicals
that
have
been
measured
in
food.
If
EPA
relies
on
such
information,
EPA
must
require
that
data
be
provided
5
years
after
the
tolerance
is
established,
modified,
or
left
in
effect,
demonstrating
that
the
levels
in
food
are
not
above
the
levels
anticipated.
Following
the
initial
data
submission,
EPA
is
authorized
to
require
similar
data
on
a
time
frame
it
deems
appropriate.
As
required
by
section
408(
b)(
2)(
E)
of
the
FFDCA,
EPA
will
issue
a
data
call­
in
for
information
relating
to
anticipated
residues
to
be
submitted
no
later
than
5
years
from
the
date
of
issuance
of
this
tolerance.
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.
The
Agency
used
PCT
information
as
follows:
Almond
5%;
apple
28%;
apricot
5%;
avocado
5%,
bean,
snap
9%;
broccoli
62%;
cabbage
32%;
cauliflower
54%;
celery
78%;
collards
24%;
cherry
5%;
eggplant
14%;
grapefruit
1%;
grape,
wine
1%;
kale
32%;
lemon
11%;
lettuce,
head
59%;
Lettuce,
other
42%;
mustard
greens
17%;
orange
6%;
peach
4%;
pepper
45%;
pistachio
1%;
prune/
plum
5%;
spinach
32%;
pumpkin
1%;
squash
1%;
sweet
corn
1%;
tangerine
6%;
turnip,
greens
6%;
tomato,
fresh
30%;
tomato,
processed
2%;
watermelon
1%;
cotton
3%;
dry
bean/
pea
1%;
peanut
1%;
potato
1%;
wheat,
and
winter
1%.
The
Agency
believes
that
the
3
conditions
listed
above
have
been
met.
With
respect
to
condition
1,
PCT
estimates
are
derived
from
Federal
and
private
market
survey
data,
which
are
reliable
and
have
a
valid
basis.
EPA
uses
a
weighted
average
PCT
for
chronic
dietary
exposure
estimates.
This
weighted
average
PCT
figure
is
derived
by
averaging
State­
level
data
for
a
period
of
up
to
10
years,
and
weighting
for
the
more
robust
and
recent
data.
A
weighted
average
of
the
PCT
reasonably
represents
a
person's
dietary
exposure
over
a
lifetime,
and
is
unlikely
to
underestimate
exposure
to
an
individual
because
of
the
fact
that
pesticide
use
patterns
(
both
regionally
and
nationally)
tend
to
change
continuously
over
time,
such
that
an
individual
is
unlikely
to
be
exposed
to
more
than
the
average
PCT
over
a
lifetime.
For
acute
dietary
exposure
estimates,
EPA
uses
an
estimated
maximum
PCT.
The
exposure
estimates
resulting
from
this
approach
reasonably
represent
the
highest
levels
to
which
an
individual
could
be
exposed,
and
are
unlikely
to
underestimate
an
individual's
acute
dietary
exposure.
The
Agency
is
reasonably
certain
that
the
percentage
of
the
food
treated
is
not
likely
to
be
an
underestimation.
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
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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
spinosad
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
spinosad
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
spinosad.
The
Agency
uses
the
First
Index
Reservoir
Screening
Tool
(
FIRST)
or
the
Pesticide
Root
Zone/
Exposure
Analysis
Modeling
System
(
PRZM/
EXAMS)
to
produce
estimates
of
pesticide
concentrations
in
an
index
reservoir.
The
screening
concentration
in
ground
water
(
SCI­
GROW)
model
is
used
to
predict
pesticide
concentrations
in
shallow
ground
water.
For
a
screeninglevel
assessment
for
surface
water
EPA
will
generally
use
FIRST
(
a
Tier
1
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.
While
both
FIRST
and
PRZM/
EXAMS
incorporate
an
index
reservoir
environment,
the
PRZM/
EXAMS
model
includes
a
percent
crop
area
factor
as
an
adjustment
to
account
for
the
maximum
percent
crop
coverage
within
a
watershed
or
drainage
basin.
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
of
pesticides
from
the
source
water.
The
primary
use
of
these
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
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
%
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
spinosad
they
are
further
discussed
in
the
aggregate
risk
sections
below.
Based
on
the
FIRST
and
SCI­
GROW
models
the
EECs
of
spinosad
for
acute
exposures
are
estimated
to
be
25
parts
per
billion
(
ppb)
for
surface
water
and
0.037
ppb
for
ground
water.
The
EECs
for
chronic
exposures
are
estimated
to
be
2.3
ppb
for
surface
water
and
0.037
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).
Spinosad
is
currently
registered
for
use
on
residential
turf
and
ornamentals
to
control
a
variety
of
insect
pests.
The
registered
residential
products
for
spinosad
are
Conserve
SC
Turf
and
Ornamental
(
EPA
Reg
No.
62719
 
291)
and
Conserve
Fire
Ant
Bait
(
EPA
Reg
No.
62719
 
304).
Conserve
Fire
Ant
Bait
is
a
ready­
to­
use
granular
formulation
that
may
be
applied
by
homeowners.
For
adults,
residential
exposures
may
result
from
dermal
and
inhalation
exposure
while
applying
Conserve
Fire
Ant
Bait
and/
or
from
dermal
contact
with
treated
turf.
However,
dermal,
post­
application
exposure
is
not
of
concern
since
no
toxicological
endpoint
was
established
for
dermal
exposure.
Inhalation
exposure
is
not
expected
due
to
the
low
vapor
pressure
of
spinosad
and
because
the
homeowner
product
is
formulated
as
a
granular.
Postapplication
exposure
to
toddlers
was
not
assessed
for
the
Conserve
Fire
Ant
Bait
product
since
children
are
not
likely
to
``
habit''
lawn
areas
where
fire
ant
mounds
are
present.
Conserve
SC
is
labeled
for
use
on
turfgrass
and
ornamentals
by
commercial
applicators.
Since
this
product
will
be
applied
by
commercial
applicators,
homeowner
applicator
exposure
was
not
assessed.
For
toddlers,
dermal
and
non­
dietary
oral
post­
application
exposures
may
result
from
dermal
contact
with
treated
turf
as
well
as
hand­
to­
mouth
transfer
of
residues
from
turfgrass.
Since
dermal
post­
application
exposure
is
not
of
concern,
only
hand­
to­
mouth,
object­
tomouth
and
incidental
ingestion
of
soil
exposures
for
the
turf
and
ornamental
uses
were
performed.
The
average
aerobic
soil
metabolism
half­
life
of
spinosad
(
containing
factors
A
and
D)
is
13
 
14
days.
For
the
intermediate­
term
duration,
typical
lawn
maintenance
practices,
such
as
mowing
and
watering,
are
expected
to
expedite
the
dissipation
of
spinosad
on
turfgrass.
Since
residue
on
turf
that
is
available
for
transfer
after
day
30
is
expected
to
be
negligible,
intermediate­
term
post­
application
incidental
oral
exposures
were
not
assessed.
The
Agency
developed
exposure
formulas
and
estimated
doses
to
theoretically
assess
residential
postapplication
incidental
oral
exposure
scenarios
including:
(
1)
Hand­
to­
mouth,
(
2)
object­
to­
mouth
(
turfgrass),
and
(
3)
incidental
ingestion
of
soil.
The
resulting
incidental
oral
ingestion
MOEs
from
residential
use
of
spinosad
on
turf
are
as
follow:

 
MOE
for
oral
hand­
to­
mouth
activities
on
treated
lawns
is
800
for
short­
term
(
1
 
30
days).

 
MOE
for
oral
object­
to­
mouth
(
turfgrass)
from
treated
lawns
is
3,300
for
short­
term.

 
MOE
for
incidental
ingestion
of
soil
from
treated
lawns
is
240,000
for
short­
term.

 
Combined
incidental
oral
MOE
(
hand­
to­
mouth,
object­
to­
mouth,
and
soil
ingestion)
is
640.
All
MOEs
are
below
EPA's
LOC.
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
spinosad
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,
spinosad
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
spinosad
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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151
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6,
2003
/
Rules
and
Regulations
C.
Safety
Factor
for
Infants
and
Children
1.
In
general.
FFDCA
section
408
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
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.
There
is
no
indication
of
increased
susceptibility
of
rat
and
rabbit
fetuses
to
in
utero
and/
or
postnatal
exposure.
3.
Conclusion.
There
is
a
complete
toxicity
data
base
for
spinosad
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.
This
recommendation
is
based
on:
i.
There
is
no
evidence
of
increased
susceptibility
of
rat
or
rabbit
fetuses
following
in
utero
exposure
in
the
developmental
studies
with
spinosad,
and
there
is
no
evidence
of
increased
susceptibility
of
young
rats
in
the
reproduction
study
with
spinosad.
ii.
There
are
no
residual
uncertainties
identified
in
the
exposure
data
bases;
the
dietary
food
exposure
assessment
(
chronic
only;
no
acute
endpoint
was
identified)
is
refined
using
Anticipated
Residues
calculated
from
field
trial
data
and
available
PCT
information
(
100%
crop
treated
is
assumed
for
proposed
new
uses).
iii.
The
dietary
drinking
water
exposure
is
based
on
conservative
modeling
estimates.
iv.
EPA's
Health
Effect
Division
Residential
Standard
Operating
Procedures
were
used
to
assess
postapplication
exposure
to
children
as
well
as
incidental
oral
exposure
of
toddlers,
so
these
assessments
do
not
underestimate
the
exposure
and
risks
posed
by
spinosad.
v.
A
developmental
toxicity
study
is
not
required.

D.
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.
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
+
chronic
non­
dietary,
nonoccupational
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
EPA
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
ground
water
are
less
than
the
calculated
DWLOCs,
EPA
concludes
with
reasonable
certainty
that
exposures
to
spinosad
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
spinosad
on
drinking
water
as
a
part
of
the
aggregate
risk
assessment
process.
1.
Acute
risk.
Acute
aggregate
risk
consists
of
the
combined
dietary
exposures
from
food
and
drinking
water
sources.
The
total
exposure
is
compared
to
the
acute
RfD.
An
acute
RfD
was
not
identified
since
no
effects
were
observed
in
oral
toxicity
studies
that
could
be
attributable
to
a
single
dose.
Therefore,
the
Agency
concludes
that
there
is
a
reasonable
certainty
of
no
harm
from
acute
aggregate
exposure
to
spinosad.
2.
Chronic
risk.
Using
the
exposure
assumptions
described
in
unit
C
for
chronic
exposure,
EPA
has
concluded
that
exposure
to
spinosad
from
food
will
utilize
30%
of
the
cPAD
for
the
U.
S.
population,
41%
of
the
cPAD
for
infant
<
1
year
old
and
69%
of
the
cPAD
for
children
1
 
6
years
old
(
subpopulation
at
greatest
exposure).
Based
on
the
use
pattern,
chronic
residential
exposure
to
residues
of
spinosad
is
not
expected.
In
addition,
there
is
potential
for
chronic
dietary
exposure
to
spinosad
in
drinking
water.
After
calculating
DWLOCs
and
comparing
them
to
the
EECs
for
surface
water
and
ground
water,
EPA
does
not
expect
the
aggregate
exposure
to
exceed
100%
of
the
cPAD,
as
shown
in
the
following
Table
2:

TABLE
2.
 
AGGREGATE
RISK
ASSESSMENT
FOR
CHRONIC
(
NON­
CANCER)
EXPOSURE
TO
SPINOSAD
Population
Subgroup
cPAD
mg/
kg/
day
%
cPAD
(
Food)
Surface
Water
EEC
(
ppb)
Ground
Water
EEC
(
ppb)
Chronic
DWLOC
(
ppb)

U.
S.
population
0.027
30
2.3
0.037
660
All
infants
(<
1
year
old)
0.027
41
2.3
0.037
160
Children
(
1
 
6
years
old)
0.027
69
2.3
0.037
85
Children
(
7
 
12
years
old)
0.027
45
2.3
0.037
150
Females
(
13
 
50)
0.027
24
2.3
0.037
620
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6,
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/
Rules
and
Regulations
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).
Spinosad
is
currently
registered
for
use(
s)
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
spinosad.
Using
the
exposure
assumptions
described
in
Unit
IV.
B.
for
short­
term
exposures,
EPA
has
concluded
that
food
and
residential
exposures
aggregated
result
in
aggregate
MOEs
of
600
for
the
U.
S.
population,
260
for
all
infants
less
than
1
 
year
old,
190
for
children
1
 
6
years
old
(
greatest
risk
subpopulation)
and
250
for
children
7
 
12
years
old.
These
aggregate
MOEs
do
not
exceed
the
Agency's
LOC
for
aggregate
exposure
to
food
and
residential
uses.
In
addition,
short­
term
DWLOCs
were
calculated
and
compared
to
the
EECs
for
chronic
exposure
of
spinosad
in
ground
water
and
surface
water.
After
calculating
DWLOCs
and
comparing
them
to
the
EECs
for
surface
water
and
ground
water,
EPA
does
not
expect
short­
term
aggregate
exposure
to
exceed
the
Agency's
LOC,
as
shown
in
the
following
Table
3:

TABLE
3.
 
AGGREGATE
RISK
ASSESSMENT
FOR
SHORT­
TERM
EXPOSURE
TO
SPINOSAD
Population
Subgroup
Aggregate
MOE
(
Food
+
Residential)
Aggregate
LOC
Surface
Water
EEC
(
ppb)
Ground
Water
EEC
(
ppb)
Short­
Term
DWLOC
(
ppb)

U.
S.
population
600
100
2.3
0.037
1,400
All
infants
(<
1
year
old)
260
100
2.3
0.037
300
Children
(
1
 
6
years
old)
190
100
2.3
0.037
230
Children
(
7
 
12
years
old)
250
100
2.3
0.037
290
Female
(
13
 
50)
760
100
2.3
0.037
1,300
4.
Intermediate­
term
risk.
Intermediate­
term
aggregate
exposure
takes
into
account
non­
dietary,
nonoccupational
exposure
plus
chronic
exposure
to
food
and
water
(
considered
to
be
a
background
exposure
level).
Though
residential
exposure
could
occur
with
the
use
of
spinosad,
the
average
aerobic
soil
metabolism
half­
life
of
spinosad
(
containing
factors
A
and
D)
is
13
 
14
days.
For
the
intermediate­
term
duration,
typical
lawn
maintenance
practices,
such
as
mowing
and
watering,
are
expected
to
expedite
the
dissipation
of
spinosad
on
turfgrass.
Since
residue
on
turf
that
is
available
for
transfer
after
day
30
is
expected
to
be
negligible,
intermediate­
term
post­
application
incidental
oral
exposures
were
not
assessed.
5.
Aggregate
cancer
risk
for
U.
S.
population.
Spinosad
has
been
classified
as
``
not
likely
to
be
carcinogenic
in
humans''
based
on
the
results
of
a
carcinogenicity
study
in
mice
and
the
combined
chronic
toxicity
and
carcinogenicity
study
in
rats.
Therefore,
spinosad
is
not
expected
to
pose
a
cancer
risk
to
humans.
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
spinosad
residues.
V.
Other
Considerations
A.
Analytical
Enforcement
Methodology
Adequate
enforcement
methodology
using
high
pressure
liquid
chromatography
with
ultraviolet
detector
(
HPLC/
UV)
is
available
to
enforce
the
tolerances
in
plants.
Adequate
livestock
methods
are
available
for
tolerance
enforcement.
Method
RES
94094
(
GRM
95.03)
is
an
HPLC/
UV
method
suitable
for
determination
of
spinosad
residues
in
ruminant
commodities.
Method
GRM
95.03
has
undergone
successful
independent
laboratory
validation
(
ILV)
and
EPA
laboratory
validation,
and
has
been
forwarded
to
FDA
for
inclusion
in
PAM
Volume
II.
Method
GRM
95.15
is
another
HPLC/
UV
method
suitable
for
determination
of
spinosad
residues
in
poultry
commodities.
This
method
has
been
forwarded
to
FDA
for
inclusion
in
PAM
Volume
II.
Method
RES
95114,
an
immunoassay
method
for
determination
of
spinosad
residues
in
ruminant
commodities,
underwent
a
successful
ILV
and
EPA
laboratory
validation.
It
has
been
submitted
to
FDA
for
inclusion
in
PAM
Volume
II.
The
methods
may
be
requested
from:
Paul
Golden,
U.
S.
EPA/
OPP/
BEAD/
ACB,
Environmental
Science
Center,
701
Mapes
Road,
Fort
Meade,
MD
20755
 
5350;
telephone
number:
(
410)
305
 
2960;
FAX
(
410)
305
 
3091;
e­
mail
address:
RAM
Mailbox.

B.
International
Residue
Limits
There
are
no
Codex,
Canadian
or
Mexican
maximum
residue
limits
established
for
spinosad
in/
on
root
and
tuber
vegetables.
Therefore,
no
compatibility
problems
exist
for
the
proposed
tolerances.

VI.
Conclusion
Therefore,
the
tolerance
is
established
for
residues
of
spinosad
in
or
on
onion,
dry
bulb
at
0.10
ppm.

VII.
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
the
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
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Vol.
68,
No.
151
/
Wednesday,
August
6,
2003
/
Rules
and
Regulations
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
 
0207
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
6,
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
VII.
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
the
docket
ID
number
OPP
 
2003
 
0207,
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:
opp­
docket@
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).

VIII.
Statutory
and
Executive
Order
Reviews
This
final
rule
establishes
a
timelimited
tolerance
under
section
408
of
the
FFDCA.
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
FIFRA
section
18
exemption
under
section
408
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
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Federal
Register
/
Vol.
68,
No.
151
/
Wednesday,
August
6,
2003
/
Rules
and
Regulations
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.

IX.
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
record
keeping
requirements.

Dated:
July
28,
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
180.495
is
amended
by
alphabetically
adding
the
following
commodity
to
the
table
in
paragraph
(
b)
to
read
as
follows:

§
180.495
Spinosad;
tolerances
for
residues.

*
*
*
*
*
(
b)
*
*
*

Commodity
Parts
per
million
Expiration/
Revocation
date
*
*
*
*
*
Onion,
dry
bulb
..................................................................................................................
0.10
12/
31/
06
*
*
*
*
*

*
*
*
*
*
[
FR
Doc.
03
 
20017
Filed
8
 
5
 
03;
8:
45
am]

BILLING
CODE
6560
 
50
 
S
FEDERAL
COMMUNICATIONS
COMMISSION
47
CFR
Part
69
[
CC
Docket
No.
01
 
174;
FCC
03
 
151]

2000
Biennial
Review
 
Requirement
Governing
the
NECA
Board
of
Directors
AGENCY:
Federal
Communications
Commission.
ACTION:
Final
rule.

SUMMARY:
In
this
document,
the
Commission
modifies
the
requirements
governing
how
the
National
Exchange
Carrier
Association
(
NECA)
conducts
elections
for
its
board
of
directors
(
Board).
The
Commission
eliminates
the
requirement
that
NECA
hold
annual
elections
and
that
Board
members
serve
one­
year
terms.
The
Commission
also
liberalizes
its
rules
regarding
contested
elections
for
NECA's
nontelecommunications
industry
directors
(
Outside
Directors).
DATES:
Effective
September
5,
2003.

FOR
FURTHER
INFORMATION
CONTACT:
Cara
Voth,
Attorney,
Telecommunications
Access
Policy
Division,
Wireline
Competition
Bureau,
(
202)
418
 
7400.

SUPPLEMENTARY
INFORMATION:
This
is
a
summary
of
the
Commission's
Report
and
Order
in
CC
Docket
No.
01
 
174,
FCC
03
 
151
released
on
July
3,
2003.
The
full
text
of
this
document
is
available
for
public
inspection
during
regular
business
hours
in
the
FCC
Reference
Center,
Room
CY
 
A257,
445
Twelfth
Street
SW.,
Washington,
DC,
20554.

I.
Introduction
1.
In
this
Report
and
Order,
as
part
of
our
biennial
regulatory
review
under
section
11
of
the
Communications
Act
of
1934,
as
amended
(
the
Act),
we
modify
the
requirements
governing
how
the
National
Exchange
Carrier
Association
(
NECA)
conducts
elections
for
its
board
of
directors
(
Board).
We
eliminate
the
requirement
that
NECA
hold
annual
elections
and
that
Board
members
serve
one­
year
terms.
We
also
liberalize
our
rules
regarding
contested
elections
for
NECA's
nontelecommunications
industry
directors
(
Outside
Directors).
Under
the
liberalized
rules,
no
Outside
Director
may
serve
for
more
than
six
consecutive
calendar
years
without
standing
for
an
election
in
which
that
director
is
opposed
by
at
least
one
other
qualified
candidate.
By
modifying
our
election
requirements
for
the
Board,
we
reduce
the
regulatory
burdens
that
the
current
election
requirements
impose
on
NECA,
while
furthering
our
goal
of
ensuring
that
NECA
fulfills
certain
Commissionspecified
functions.

II.
Discussion
2.
We
find
that
the
current
election
process
imposes
several
unnecessary
administrative
burdens
on
NECA
and
therefore
we
eliminate
certain
election
requirements
for
NECA's
Board.
We
also
find,
however,
that
because
NECA
continues
to
perform
certain
functions
pursuant
to
Commission
rules,
we
have
a
continuing
interest
in
ensuring
that
NECA
fulfills
its
obligations.
In
retaining
certain
requirements,
we
seek
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