Document ID: EPA-HQ-OPP-2003-0284-0001
Agency: epa
Document Type: Rule
Title: Propylene Carbonate; Exemption from the Requirement of a Tolerance
Posted Date: 2003-09-05T04:00Z

52695
Federal
Register
/
Vol.
68,
No.
172
/
Friday,
September
5,
2003
/
Rules
and
Regulations
EPA­
APPROVED
NEBRASKA
REGULATIONS
 
Continued
Nebraska
citation
Title
State
effective
date
EPA
approval
date
Comments
*
*
*
*
*
*
*

129
 
30
....................................
Open
Fires,
Prohibited;
Exceptions
11/
20/
02
9/
5/
03
and
FR
page
citation.

*
*
*
*
*
*
*

*
*
*
*
*

PART
70
 
[
AMENDED]

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

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

Appendix
A
 
[
Amended]


2.
Appendix
A
to
part
70
is
amended
by
adding
paragraph
(
g)
under
Nebraska;
City
of
Omaha;
Lincoln­
Lancaster
County
Health
Department
to
read
as
follows:

Appendix
A
to
Part
70
 
Approval
Status
of
State
and
Local
Operating
Permits
Programs
*
*
*
*
*
Nebraska;
City
of
Omaha;
Lincoln­
Lancaster
County
Health
Department.

*
*
*
*
*
(
g)
The
Nebraska
Department
of
Environmental
Quality
approved
revisions
to
NDEQ
Title
129,
chapters
1,
5,
6,
and
appendix
III
(
which
codifies
its
prior
Federally
approved
Insignificant
Activities
List)
on
September
5,
2002,
which
became
effective
on
November
20,
2002.
These
revisions
were
submitted
on
May
1,
2003.
We
are
approving
these
program
revisions
effective
November
4,
2003.

*
*
*
*
*

[
FR
Doc.
03
 
22539
Filed
9
 
4
 
03;
8:
45
am]

BILLING
CODE
6560
 
50
 
P
ENVIRONMENTAL
PROTECTION
AGENCY
40
CFR
Part
180
[
OPP
 
2003
 
0284;
FRL
 
7323
 
7]

Propylene
Carbonate;
Exemption
from
the
Requirement
of
a
Tolerance
AGENCY:
Environmental
Protection
Agency
(
EPA).
ACTION:
Final
rule.

SUMMARY:
This
regulation
establishes
an
exemption
from
the
requirement
of
a
tolerance
for
residues
of
propylene
carbonate
when
used
as
an
inert
ingredient
in
pesticide
formulations
applied
pre­
and
post­
harvest
to
agricultural
commodities.
Huntsman
Corporation
submitted
a
petition
to
EPA
under
the
Federal
Food,
Drug,
and
Cosmetic
Act,
as
amended
by
the
Food
Quality
Protection
Act
of
1996,
requesting
an
exemption
from
the
requirement
of
a
tolerance.
This
regulation
eliminates
the
need
to
establish
a
maximum
permissible
level
for
residues
of
propylene
carbonate.
DATES:
This
regulation
is
effective
September
5,
2003.
Objections
and
requests
for
hearings,
identified
by
docket
ID
number
OPP
 
2003
 
0284,
must
be
received
on
or
before
November
4,
2003.
ADDRESSES:
Written
objections
and
hearing
requests
submitted
electronically,
by
mail,
or
through
hand
delivery/
courier.
Follow
the
detailed
instructions
as
provided
in
Unit
VIII.
of
the
SUPPLEMENTARY
INFORMATION.
FOR
FURTHER
INFORMATION
CONTACT:
Kathryn
Boyle,
Registration
Division
(
7505C),
Office
of
Pesticide
Programs,
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460
 
0001;
telephone
number:
(
703)
305
 
6304;
e­
mail
address:
boyle.
kathryn@
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)
 
Animal
production
(
NAICS
112)
 
Food
manufacturing
(
NAICS
311)
 
Pesticide
manufacturing
(
NAICS
32532)
This
listing
is
not
intended
to
be
exhaustive,
but
rather
provides
a
guide
for
readers
regarding
entities
likely
to
be
affected
by
this
action.
Other
types
of
entities
not
listed
in
this
unit
could
also
be
affected.
The
North
American
Industrial
Classification
System
(
NAICS)
codes
have
been
provided
to
assist
you
and
others
in
determining
whether
this
action
might
apply
to
certain
entities.
If
you
have
any
questions
regarding
the
applicability
of
this
action
to
a
particular
entity,
consult
the
person
listed
underFOR
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
 
0284.
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
athttp://
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
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172
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5,
2003
/
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and
Regulations
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
December
30,
1998
(
63
FR
71920)
(
FRL
 
6050
 
1),
EPA
issued
a
notice
pursuant
to
section
408
of
the
Federal
Food,
Drug,
and
Cosmetic
Act
(
FFDCA),
21
U.
S.
C.
346a,
as
amended
by
the
Food
Quality
Protection
Act
(
FQPA)
(
Public
Law
104
 
170),
announcing
the
filing
of
a
pesticide
tolerance
petition
(
PP
8E4992)
by
Huntsman
Corporation,
Houston,
Texas.
This
notice
included
a
summary
of
the
petition
prepared
by
the
petitioner
Huntsman.
There
were
no
comments
received
in
response
to
the
notice
of
filing.
The
petition
requested
that
40
CFR
180.1001(
c)
be
amended
by
establishing
an
exemption
from
the
requirement
of
a
tolerance
for
residues
of
propylene
carbonate,
also
known
as
1,3­
Dioxolan­
2­
one,
4­
methyl­
(
CAS
Reg.
No.
108
 
32
 
7).
Section
408(
b)(
2)(
A)(
i)
of
the
FFDCA
allows
EPA
to
establish
an
exemption
from
the
requirement
for
a
tolerance
(
the
legal
limit
for
a
pesticide
chemical
residue
in
or
on
a
food)
only
if
EPA
determines
that
the
tolerance
is
``
safe.''
Section
408(
b)(
2)(
A)(
ii)
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)
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.
First,
EPA
determines
the
toxicity
of
pesticides.
Second,
EPA
examines
exposure
to
the
pesticide
through
food,
drinking
water,
and
through
other
exposures
that
occur
as
a
result
of
pesticide
use
in
residential
settings.
III.
Human
Health
Assessment
A.
Toxicological
Profile
Consistent
with
section
408(
b)(
2)(
D)
of
FFDCA,
EPA
has
reviewed
the
available
scientific
data
and
other
relevant
information
in
support
of
this
action
and
considered
its
validity,
completeness
and
reliability
and
the
relationship
of
this
information
to
human
risk.
EPA
has
also
considered
available
information
concerning
the
variability
of
the
sensitivities
of
major
identifiable
subgroups
of
consumers,
including
infants
and
children.
The
nature
of
the
toxic
effects
caused
by
propylene
carbonate
are
discussed
in
this
unit.
The
Agency
has
reviewed
12
toxicity
studies
using
propylene
carbonate
as
the
test
substance.
The
results
of
those
reviews
are
listed
in
the
following
Table
1:

TABLE
1.
 
TOXICITY
STUDIES
USING
PROPYLENE
CARBONATE
Study
Type
Results
Acute
oral
(
rat)
LD50
>
5,000
mg/
kg
(
Toxicity
Category
IV)

Acute
dermal
(
rabbit)
LD50
>
2,000
mg/
kg
(
Toxicity
Category
III)

Primary
eye
irritation
(
rabbit)
Not
a
significant
ocular
irritant
(
Toxicity
Category
III)

Primary
dermal
irritation
(
Toxicity
Category
IV)

Developmental
(
rat)
Maternal
NOAEL
=
1,000
mg/
kg/
day
Maternal
LOAEL
=
3,000
mg/
kg/
day
based
on
mortality
clinical
signs
and
decreased
food
consumption
Developmental
NOAEL
=
3,000
mg/
kg/
day
Developmental
LOAEL
=
5,000
mg/
kg/
day
based
on
increase
in
skeletal
variations
113
 
week
feeding
(
rat)
NOAEL
=
equal
to
or
greater
than
5,000
mg/
kg/
day
(
HTD
­
highest
dose
tested)
LOAEL
=
would
be
greater
than
5,000
mg/
kg/
day
TABLE
1.
 
TOXICITY
STUDIES
USING
PROPYLENE
CARBONATE
 
Continued
Study
Type
Results
113
 
week
inhalation
(
rat)
with
neurotox
NOAEL
=
0.5
mg/
L/
day
LOAEL
=
1.0
mg/
L/
daybased
on
clinical
signs
in
both
sexes
No
evidence
of
neurotoxicpotential
Cancer
dermal
(
skinpainting
(
mouse)
Negative,
but
dosing
was
considered
inadequate
9
 
day
inhalation
(
rat)
NOAEL
=
not
determined
­
effects
seen
at
lowest
dose
tested
LOAEL
=
1
mg/
L/
day
based
on
clinical
signs
of
toxicity
ocular
irritation
Mouse
micronucleus
Not
mutagenic
UDS
Negative
Gene
mutation(
S.
typhimurium)
Negative
B.
Structure
Activity
Relationship
Assessment
For
propylene
carbonate,
toxicity
was
assessed,
in
part,
by
a
process
called
structure­
activity­
relationship
(
SAR).
In
this
process,
the
chemical's
structural
similarity
to
other
chemicals
(
for
which
data
are
available)
is
used
to
determine
toxicity.
For
human
health,
this
process,
can
be
used
to
assess
absorption
and
metabolism,
mutagenicity,
carcinogenicity,
developmental
and
reproductive
effects,
neurotoxicity,
systemic
effects,
immunotoxicity,
and
sensitization
and
irritation.
This
is
a
qualitative
assessment
using
terms
such
as
good,
not
likely,
poor,
moderate,
or
high.
For
propylene
carbonate
the
SAR
assessment
determined
that
the
chemical
was
not
structurally
related
to
any
known
carcinogens.
The
following
human
exposures
were
examined
as
part
of
the
analysis:
Inhalation,
dermal,
exposures
to
the
eyes,
and
drinking
water.
Absorption
of
propylene
carbonate
is
expected
to
be
good
(
wellabsorbed
via
all
routes
(
oral,
dermal
and
inhalation)
based
on
physical/
chemical
properties.
There
are
concerns
for
effects
on
the
liver
and
kidneys,
solvent­
type
neurotoxicity
and
developmental
toxicity
at
high
dose
levels,
and
irritation
to
mucous
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membranes.
The
overall
SAR
rating
for
human
health
is
low/
moderate
concern.
The
SAR
did
note
a
concern
for
solvent
neurotoxicity,
i.
e.,
neurotoxic
effects
that
can
occur
due
to
``
high''
and/
or
``
prolonged''
dermal
and
inhalation
exposures
to
organic
solvents.
It
should
be
noted
that
the
inclusion
of
the
phrase
``
solvent­
type
neurotoxicity''
in
the
SAR
assessment
does
not
necessarily
indicate
chemicalspecific
concerns.
By
including
this
statement
those
performing
the
SAR
assessment
are
acknowledging
that
the
chemical
is
a
member
of
a
class
of
chemicals
that
can
exhibit
solvent
neurotoxicity.

C.
Conclusions
The
Agency
used
two
sources
of
information
to
determine
the
toxicity
of
propylene
carbonate:
The
12
toxicity
studies
submitted
by
the
petitioner
and
reviewed
by
the
Agency,
and
a
SAR
assessment.
The
two
sources
of
data
support
each
other.
However,
results
of
the
SAR
Assessment
are
a
type
of
predicted
data
based
in
part
on
surrogate
data.
There
is
actual
data
generated
using
propylene
carbonate
as
the
test
substance,
and
actual
data
has
precedence
over
predicted
data.
The
Agency
reviewed
a
propylene
carbonate
developmental
toxicity
study
in
the
rat
with
a
maternal
no
observed
adverse
effect
level
(
NOAEL)
of
1,000
milligrams/
kilogram/
day
(
mg/
kg/
day)
and
a
maternal
lowest
observed
adverse
effect
level
(
LOAEL)
of
3,000
mg/
kg/
day
based
on
mortality,
clinical
signs
and
decreased
food
consumption.
In
the
same
study,
the
developmental
NOAEL
is
3,000
mg/
kg/
day
and
the
developmental
LOAEL
is
5,000
mg/
kg/
day
based
on
an
increase
in
skeletal
variations.
In
a
propylene
carbonate
13
 
week
rat
feeding
study
the
NOAEL
is
equal
to
or
greater
than
5,000
mg/
kg/
day,
the
highest
dose
tested.
A
LOAEL
was
not
identified
in
that
study,
but
it
would
be
even
greater
than
5,000
mg/
kg/
day.
It
is
noted
that
each
of
these
NOAELs
is
equal
to
or
greater
than
1,000
mg/
kg/
day.
As
a
matter
of
practice,
for
both
the
developmental
and
the
13
 
week
toxicity
study,
the
Agency
does
not
encourage
testing
above
1,000
mg/
kg/
day.
The
lack
of
effects
at
1,000
mg/
kg/
day
is
considered
adequate
to
define
the
toxicity,
without
pushing
the
dose
levels
higher
until
effects
are
apparent.
The
SAR
assessment
judged
propylene
carbonate
to
be
of
low/
moderate
concern.
It
did
not
identify
any
carcinogenic
concerns.
One
identified
concern
was
for
possible
irritation
to
mucous
membranes.
This
concern
would
involve
the
dermal
and
inhalation
exposure
routes
and
would
be
addressed
through
the
use
of
protective
equipment
such
as
gloves
and
respirators,
not
through
establishment
of
tolerance
exemptions.
A
concern
predicted
by
the
SAR,
based
on
its
structural
chemistry
and
chemical
class,
is
for
possible
solvent
neurotoxicity
from
exposure
to
propylene
carbonate.
As
previously
explained,
this
statement
acknowledges
that
propylene
carbonate
is
a
member
of
a
class
of
chemicals
that
can
exhibit
solvent
neurotoxicity.
However,
the
propylene
carbonate
data
base
includes
a
13
 
week
inhalation
toxicity
study
in
the
rat
with
a
neurotoxicity
evaluation.
Based
on
its
review
and
evaluation
of
this
inhalation
toxicity
study,
the
Agency
determined
that
there
was
no
evidence
of
neurotoxicity
potential.
The
SAR
also
indicated
a
concern
for
developmental
toxicity
at
high
dose
levels.
However,
the
Agency
reviewed
a
propylene
carbonate
developmental
toxicity
study
in
the
rat
with
a
maternal
NOAEL
of
1,000
mg/
kg/
day
and
a
maternal
LOAEL
of
3,000
mg/
kg/
day
based
on
mortality,
clinical
signs
and
decreased
food
consumption.
In
the
same
study,
the
developmental
NOAEL
is
3,000
mg/
kg/
day
and
the
developmental
LOAEL
is
5,000
mg/
kg/
day
based
on
increase
in
skeletal
variations.
Considering
the
NOAELs
of
greater
than
1,000
mg/
kg/
day
for
the
propylene
carbonate
toxicity
studies
and
the
overall
judgement
of
low/
moderate
concern
from
the
SAR
assessment,
propylene
carbonate
is
of
low
toxicological
concern.

IV.
Aggregate
Exposures
In
examining
aggregate
exposure,
FFDCA
section
408
directs
EPA
to
consider
available
information
concerning
exposures
from
the
pesticide
residue
in
food
and
all
other
nonoccupational
exposures,
including
drinking
water
from
ground
water
or
surface
water
and
exposure
through
pesticide
use
in
gardens,
lawns,
or
buildings
(
residential
and
other
indoor
uses).
Over
1
million
pounds
of
propylene
carbonate
are
either
produced
or
imported
per
year.
Some
of
this
propylene
carbonate
production
is
used
as
a
chemical
intermediate,
in
the
production
of
other
chemicals.
Propylene
carbonate
has
been
approved
by
the
Food
and
Drug
Administration
for
use
as
an
indirect
food
additive
as
a
component
of
adhesives.
According
to
21
CFR
175.105,
propylene
carbonate
can
be
a
component
of
an
adhesive
used
as
part
of
``
articles
intended
for
use
in
packaging,
transporting,
or
holding
food.''
Propylene
carbonate
is
also
used
in
cosmetics.
Information
on
the
internet
(
Huntsman
website)
indicates
that
propylene
carbonate
is
used
in
tub
and
tile
cleaners,
hard
surface
and
floor
cleaners
that
could
be
used
in
and
around
the
home.
The
Agency
has
used
various
screening­
level
models
to
estimate
some
of
the
existing
levels
of
exposure,
and
those
that
could
occur
as
a
result
of
establishing
this
tolerance
exemption.
To
assure
protectiveness,
these
estimates
are
deliberately
intended
to
over­
estimate
exposure
as
shown
in
the
following
Table
2:

TABLE
2.
 
SCREENING­
LEVELS
OF
EXPOSURE
USING
PROPYLENE
CARBONATE
Type
of
Exposure
Exposure
Level
Dietary
­
Food
(
as
a
result
of
application
to
crops)
Acute
exposure:
Less
than
1
mg/
kg/
day
at
95th
percentile
chronic
exposure:
Less
than
1
mg/
kg/
day
Dietary
­
Drinking
Water
Acute
exposure:
Much
less
than
1
mg/
kg/
day
Chronic
exposure:
Much
less
than
1
mg/
kg/
day
Residential
(
as
a
result
of
using
a
cleaning
product)
Approximately
6
mg/
kg/
day
Residential
(
as
a
result
of
using
a
laundry
detergent)
Approximately
1
mg/
kg/
day
Residential
(
as
a
result
of
application
to
a
lawn)
Less
than
1
mg/
kg/
day
With
one
exception
all
of
the
screening­
level
exposure
estimates
are
in
the
range
of
or
less
than
1
mg/
kg/
day.
The
existing
studies
for
propylene
carbonate
yielded
NOAELs
that
were
equal
to
or
greater
than
1,000
mg/
kg/
day.
The
screening­
level
exposure
estimates
are
orders
of
magnitude
lower
than
these
NOAELs.
Even
considering
the
reported
uses,
the
use
of
propylene
carbonate
as
an
inert
ingredient
should
result
in
human
exposure
far
below
any
dose
level
that
could
possibly
produce
an
adverse
effect.

V.
Cumulative
Effects
from
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
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and
Regulations
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
propylene
carbonate
has
a
common
mechanism
of
toxicity
with
other
substances.
Unlike
other
pesticides
for
which
EPA
has
followed
a
cumulative
risk
approach
based
on
a
common
mechanism
of
toxicity,
EPA
has
not
made
a
common
mechanism
of
toxicity
finding
as
to
propylene
carbonate
and
any
other
substances
and
propylene
carbonate
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
propylene
carbonate
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
policy
statements
released
by
EPA's
Office
of
Pesticide
Programs
concerning
common
mechanism
determinations
and
procedures
for
cumulating
effects
from
substances
found
to
have
a
common
mechanism
on
EPA's
website
athttp://
www.
epa.
gov/
pesticides/
cumulative/.

VI.
Determination
of
Safety
for
U.
S.
Population,
Infants
and
Children
Based
on
the
available
data,
the
SAR
assessment
indicating
low/
moderate
concern
and
the
data
submitted
by
the
petitioner,
Huntsman
Corporation,
which
indicate
that
the
chemical
is
of
low
toxicological
concern,
EPA
concludes
that
propylene
carbonate
does
not
pose
a
dietary
risk
under
reasonably
foreseeable
circumstances.
Accordingly,
EPA
finds
that
there
is
a
reasonable
certainty
that
no
harm
will
result
to
the
general
population,
and
to
infants
and
children
from
aggregate
exposure
to
propylene
carbonate.
Due
to
the
expected
low
oral
toxicity,
a
safety
factor
analysis
has
not
been
used
to
assess
the
risk.
For
the
same
reasons
and
especially
considering
the
developmental
toxicity
NOAEL,
the
additional
tenfold
safety
factor
for
the
protection
of
infants
and
children
is
unnecessary.
Based
on
the
information
in
this
preamble,
EPA
concludes
that
there
is
a
reasonable
certainty
of
no
harm
from
aggregate
exposure
to
residues
of
1,3­
Dioxolan­
2­
one,
4­
methyl­
(
propylene
carbonate).
Accordingly,
EPA
finds
that
exempting
1,3­
Dioxolan­
2­
one,
4­
methyl­(
propylene
carbonate)
(
CAS
Reg.
No.
108
 
32
 
7)
from
the
requirement
of
a
tolerance
will
be
safe.

VII.
Other
Considerations
A.
Endocrine
Disruptors
FQPA
requires
EPA
to
develop
a
screening
program
to
determine
whether
certain
substances,
including
all
pesticide
chemicals
(
both
inert
and
active
ingredients),
``
may
have
an
effect
in
humans
that
is
similar
to
an
effect
produced
by
a
naturally
occurring
estrogen,
or
such
other
endocrine
effect.
.
.''
EPA
has
been
working
with
interested
stakeholders
to
develop
a
screening
and
testing
program
as
well
as
a
priority
setting
scheme.
As
the
Agency
proceeds
with
implementation
of
this
program,
further
testing
of
products
containing
propylene
carbonate
for
endocrine
effects
may
be
required.

B.
Analytical
Method(
s)
An
analytical
method
is
not
required
for
enforcement
purposes
since
the
Agency
is
establishing
an
exemption
from
the
requirement
of
a
tolerance
without
any
numerical
limitation.

C.
Existing
Tolerances
There
are
no
existing
tolerances
or
tolerance
exemptions
for
propylene
carbonate.

D.
International
Tolerances
The
Agency
is
not
aware
of
any
country
requiring
a
tolerance
for
propylene
carbonate
nor
have
any
CODEX
Maximum
Residue
Levels
been
established
for
any
food
crops
at
this
time.

E.
List
4A
(
Minimal
Risk)
Classification
The
Agency
established
40
CFR
180.950
(
see
the
rationale
in
the
proposed
rule
published
January
15,
2002
(
67
FR
1925)
(
FRL
 
6807
 
8))
to
collect
the
tolerance
exemptions
for
those
substances
classified
as
List
4A,
i.
e.,
minimal
risk
substances.
As
part
of
evaluating
an
inert
ingredient
and
establishing
the
tolerance
exemption,
the
Agency
determines
the
chemical's
list
classification.
The
available
data
and
the
SAR
assessment
indicated
propylene
carbonate
is
of
lower
toxicity.
Given
the
NOAELs
of
greater
than
1,000
mg/
kg/
day
and
the
acute
toxicity
studies
that
were
category
III
and
IV,
it
has
been
determined
that
propylene
carbonate,
also
known
as
1,3­
Dioxolan­
2­
one,
4­
methyl­
(
CAS
Reg.
No.
108
 
32
 
7)
is
to
be
classified
as
a
List
4A
inert
ingredient.
Thus,
the
tolerance
exemption
will
be
established
in
40
CFR
180.950
instead
of
40
CFR
180.1001(
c)
as
requested
by
the
petitioner,
Huntsman.
VIII.
Conclusions
Based
on
the
information
in
the
record,
summarized
in
this
preamble,
EPA
concludes
that
there
is
a
reasonable
certainty
of
no
harm
from
aggregate
exposure
to
residues
of
propylene
carbonate
(
CAS
Reg.
No.
108
 
32
 
7).
Accordingly,
EPA
finds
that
exempting
propylene
carbonate
from
the
requirement
of
a
tolerance
will
be
safe.

IX.
Objections
and
Hearing
Requests
Under
section
408(
g)
of
the
FFDCA,
as
amended
by
the
FQPA,
any
person
may
file
an
objection
to
any
aspect
of
this
regulation
and
may
also
request
a
hearing
on
those
objections.
The
EPA
procedural
regulations
which
govern
the
submission
of
objections
and
requests
for
hearings
appear
in
40
CFR
part
178.
Although
the
procedures
in
those
regulations
require
some
modification
to
reflect
the
amendments
made
to
the
FFDCA
by
the
FQPA
of
1996,
EPA
will
continue
to
use
those
procedures,
with
appropriate
adjustments,
until
the
necessary
modifications
can
be
made.
The
new
section
408(
g)
provides
essentially
the
same
process
for
persons
to
``
object
''
to
a
regulation
for
an
exemption
from
the
requirement
of
a
tolerance
issued
by
EPA
under
new
section
408(
d),
as
was
provided
in
the
old
FFDCA
sections
408
and
409.
However,
the
period
for
filing
objections
is
now
60
days,
rather
than
30
days.

A.
What
Do
I
Need
to
Do
to
File
an
Objection
or
Request
a
Hearing?

You
must
file
your
objection
or
request
a
hearing
on
this
regulation
in
accordance
with
the
instructions
provided
in
this
unit
and
in
40
CFR
part
178.
To
ensure
proper
receipt
by
EPA,
you
must
identify
docket
ID
numberOPP
 
2003
 
0284
in
the
subject
line
on
the
first
page
of
your
submission.
All
requests
must
be
in
writing,
and
must
be
mailed
or
delivered
to
the
Hearing
Clerk
on
or
before
November
4,
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
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2003
/
Rules
and
Regulations
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
IX.
A.,
you
should
also
send
a
copy
of
your
request
to
the
PIRIB
for
its
inclusion
in
the
official
record
that
is
described
in
Unit
I.
B.
1.
Mail
your
copies,
identified
by
docket
ID
number
OPP
 
2003
 
0284,
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).

X.
Statutory
and
Executive
Order
Reviews
This
final
rule
establishes
an
exemption
from
the
tolerance
requirement
under
FFDCA
section
408(
d)
in
response
to
a
petition
submitted
to
the
Agency.
The
Office
of
Management
and
Budget
(
OMB)
has
exempted
these
types
of
actions
from
review
under
Executive
Order
12866,
entitled
Regulatory
Planning
and
Review
(
58
FR
51735,
October
4,
1993).
Because
this
rule
has
been
exempted
from
review
under
Executive
Order
12866
due
to
its
lack
of
significance,
this
rule
is
not
subject
to
Executive
Order
13211,
Actions
Concerning
Regulations
That
Significantly
Affect
Energy
Supply,
Distribution,
or
Use
(
66
FR
28355,
May
22,
2001).
This
final
rule
does
not
contain
any
information
collections
subject
to
OMB
approval
under
the
Paperwork
Reduction
Act
(
PRA),
44
U.
S.
C.
3501
et
seq.,
or
impose
any
enforceable
duty
or
contain
any
unfunded
mandate
as
described
under
Title
II
of
the
Unfunded
Mandates
Reform
Act
of
1995
(
UMRA)
(
Public
Law
104
 
4).
Nor
does
it
require
any
special
considerations
under
Executive
Order
12898,
entitled
Federal
Actions
to
Address
Environmental
Justice
in
Minority
Populations
and
Low­
Income
Populations
(
59
FR
7629,
February
16,
1994);
or
OMB
review
or
any
Agency
action
under
Executive
Order
13045,
entitled
Protection
of
Children
from
Environmental
Health
Risks
and
Safety
Risks
(
62
FR
19885,
April
23,
1997).
This
action
does
not
involve
any
technical
standards
that
would
require
Agency
consideration
of
voluntary
consensus
standards
pursuant
to
section
12(
d)
of
the
National
Technology
Transfer
and
Advancement
Act
of
1995
(
NTTAA),
Public
Law
104
 
113,
section
12(
d)
(
15
U.
S.
C.
272
note).
Since
tolerances
and
exemptions
that
are
established
on
the
basis
of
a
petition
under
FFDCA
section
408(
d),
such
as
the
exemption
in
this
final
rule,
do
not
require
the
issuance
of
a
proposed
rule,
the
requirements
of
the
Regulatory
Flexibility
Act
(
RFA)
(
5
U.
S.
C.
601
et
seq.)
do
not
apply.
In
addition,
the
Agency
has
determined
that
this
action
will
not
have
a
substantial
direct
effect
on
States,
on
the
relationship
between
the
national
government
and
the
States,
or
on
the
distribution
of
power
and
responsibilities
among
the
various
levels
of
government,
as
specified
in
Executive
Order
13132,
entitledFederalism
(
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
FFDCA
section
408(
n)(
4).
For
these
same
reasons,
the
Agency
has
determined
that
this
rule
does
not
have
any
``
tribal
implications''
as
described
in
Executive
Order
13175,
entitled
Consultation
and
Coordination
with
Indian
Tribal
Governments
(
65
FR
67249,
November
6,
2000).
Executive
Order
13175,
requires
EPA
to
develop
an
accountable
process
to
ensure``
meaningful
and
timely
input
by
tribal
officials
in
the
development
of
regulatory
policies
that
have
tribal
implications.''
``
Policies
that
have
tribal
implications''
is
defined
in
the
Executive
Order
to
include
regulations
that
have
``
substantial
direct
effects
on
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Federal
Register
/
Vol.
68,
No.
172
/
Friday,
September
5,
2003
/
Rules
and
Regulations
one
or
more
Indian
tribes,
on
the
relationship
between
the
Federal
Government
and
the
Indian
tribes,
or
on
the
distribution
of
power
and
responsibilities
between
the
Federal
Government
and
Indian
tribes.''
This
rule
will
not
have
substantial
direct
effects
on
tribal
governments,
on
the
relationship
between
the
Federal
Government
and
Indian
tribes,
or
on
the
distribution
of
power
and
responsibilities
between
the
Federal
Government
and
Indian
tribes,
as
specified
in
Executive
Order
13175.
Thus,
Executive
Order
13175
does
not
apply
to
this
rule.

XI.
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
theFederal
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:
August
22,
2003.
Peter
Caulkins,
Acting
Director,
Registration
Division,
Office
of
Pesticide
Programs.

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

PART
180
 
[
AMENDED]

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

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


2.
Section
180.950
is
amended
by
adding
alphabetically
the
following
ingredient
to
the
table
in
paragraph
(
e)
to
read
as
follows.

§
180.950
Tolerance
exemptions
for
minimal
risk
active
and
inert
ingredients.

*
*
*
*
*

(
e)
*
*
*

Chemical
CAS
No.

*
*
*
*
*
1,3­
Dioxolan­
2­
one,
4­
methyl­(
propylene
carbonate)
........................................................
108
 
32
 
7
*
*
*
*
*

[
FR
Doc.
03
 
22546
Filed
9
 
4
 
03;
8:
45am]

BILLING
CODE
6560
 
50
 
S
DEPARTMENT
OF
HOMELAND
SECURITY
Federal
Emergency
Management
Agency
44
CFR
Part
62
RIN
1660
 
AA29
National
Flood
Insurance
Program
(
NFIP);
Assistance
to
Private
Sector
Property
Insurers;
Extension
of
Term
of
Arrangement
AGENCY:
Federal
Emergency
Management
Agency
(
FEMA).
Emergency
Preparedness
and
Response
Directorate,
Department
of
Homeland
Security.
ACTION:
Interim
final
rule.

SUMMARY:
FEMA
is
changing
the
current
Financial
Assistance/
Subsidy
Arrangement
(
the
Arrangement)
to
extend
its
term
of
October
1,
2002,
through
September
30,
2003,
to
a
term
of
October
1,
2002,
through
December
31,
2003.
The
Arrangement
defines
the
duties
and
responsibilities
of
insurers
that
sell
and
service
insurance
under
the
Write
Your
Own
(
WYO)
program.
It
also
identifies
the
responsibilities
of
the
Government
to
provide
financial
and
technical
assistance
to
these
insurers.
DATES:
Effective
October
1,
2003.
Comments
on
this
interim
final
rule,
should
be
received
on
or
before
October
6,
2003.
ADDRESSES:
Please
send
your
comments
to
the
Rules
Docket
Clerk,
Office
of
the
General
Counsel,
Federal
Emergency
Management
Agency,
500
C
Street,
SW.,
Room
840,
Washington,
DC
20472,
(
facsimile)
202
 
646
 
4536,
or
(
e­
mail)
rules@
fema.
gov.

FOR
FURTHER
INFORMATION
CONTACT:
Edward
L.
Connor,
FEMA,
500
C
Street,
SW.,
Washington,
DC
20472,
202
 
646
 
3429
(
Phone),
202­
646
 
3445
(
facsimile),
or
Edward.
Connor@
dhs.
gov
(
e­
mail).
SUPPLEMENTARY
INFORMATION:
On
August
9,
2002,
FEMA
published
in
the
Federal
Register,
67
FR
51768,
a
final
rule
to
revise
the
effective
date
of
the
Arrangement
to
agree
with
the
new
Arrangement
year
beginning
October
1,
2002,
and
ending
September
30,
2003.
FEMA
had
planned
to
make
significant
changes
in
the
Arrangement
regarding
litigation
issues
effective
October
1,
2003.
However,
as
the
proposed
rule
for
these
changes
has
not
yet
been
published
in
the
Federal
Register,
it
is
not
feasible
to
complete
the
rulemaking
for
an
effective
date
of
October
1,
2003.
WYO
insurers
need
to
receive
an
offer
to
enter
into
the
Arrangement
each
year
well
in
advance
of
the
beginning
of
the
Arrangement
year.
By
extending
the
current
Arrangement
for
an
additional
3
months,
the
revised
Arrangement
with
the
litigation
changes
can
be
effective
January
1,
2004,
instead
of
postponing
these
changes
to
October
1,
2004.
WYO
insurers
can
always
elect
to
cease
participation
in
the
WYO
program
at
any
time,
so
any
insurer
not
desiring
to
participate
for
the
additional
3
months
of
this
extension
may
cease
participation
as
of
October
1,
2003.
Under
this
extension
of
the
current
Arrangement,
the
expense
allowance
provided
for
in
Article
III,
Section
B
of
APPENDIX
A
TO
PART
62
 
FEDERAL
EMERGENCY
MANAGEMENT
AGENCY,
FEDERAL
INSURANCE
ADMINISTRATION,
FINANCIAL
ASSISTANCE/
SUBSIDY
ARRANGEMENT
will
remain
the
same
for
the
additional
3
months
as
it
is
now,
except
there
will
be
no
additional
expense
allowance
of
up
to
two
percentage
points
for
meeting
marketing
goals
for
the
three­
month
extension.
This
additional
expense
allowance
will
be
based
on
the
period
October
1,
2002,
through
September
30,
2003.

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