Document ID: EPA-HQ-OPP-2003-0023-0001
Agency: epa
Document Type: Rule
Title: [alpha]-Hydro-[ ]-Hydroxypoly(oxyethylene) C8-C18-Alkyl Ether Citrates, Poly(oxyethylene) Content is 4-12 moles Tolerance Exemption
Posted Date: 2003-04-30T04:00Z

23069
Federal
Register
/
Vol.
68,
No.
83
/
Wednesday,
April
30,
2003
/
Rules
and
Regulations
ENVIRONMENTAL
PROTECTION
AGENCY
40
CFR
Part
180
[
OPP
 
2003
 
0023;
FRL
 
7290
 
8]

 ­
Hydro­
 ­
Hydroxypoly(
oxyethylene)
C8­
C18­
Alkyl
Ether
Citrates,
Poly(
oxyethylene)
content
is
4
 
12
moles
Tolerance
Exemption
AGENCY:
Environmental
Protection
Agency
(
EPA).
ACTION:
Final
rule.

SUMMARY:
This
regulation
establishes
an
exemption
from
the
requirement
of
a
tolerance
for
residues
of
a­
hydro­
 ­
hydroxypoly(
oxyethylene)
C8­
C18­
alkyl
ether
citrates,
poly(
oxyethylene)
content
is
4
 
12
moles
when
used
as
an
inert
ingredient.
Akzo­
Nobel
Industrial
Specialties,
Inc.,
submitted
a
petition
to
EPA
under
the
Federal
Food,
Drug,
and
Cosmetic
Act
(
FFDCA),
as
amended
by
the
Food
Quality
Protection
Act
of
1996
(
FQPA)
requesting
an
exemption
from
the
requirement
of
a
tolerance.
This
regulation
eliminates
the
need
to
establish
a
maximum
permissible
level
for
residues
of
a­
hydro­
 ­
hydroxypoly(
oxyethylene)
C8­
C18­
alkyl
ether
citrates,
poly(
oxyethylene)
content
is
4
 
12
moles.
DATES:
This
regulation
is
effective
April
30,
2003.
Objections
and
requests
for
hearings,
identified
by
docket
ID
number
OPP
 
2003
 
0023,
must
be
received
on
or
before
June
30,
2003.
ADDRESSES:
Written
objections
and
hearing
requests
may
be
submitted
electronically,
by
mail,
or
through
hand
delivery/
courier.
Follow
the
detailed
instructions
as
provided
in
Unit
XI.
of
the
SUPPLEMENTARY
INFORMATION.

FOR
FURTHER
INFORMATION
CONTACT:
Bipin
Gandhi,
Registration
Division
(
7505C),
Office
of
Pesticide
Programs,
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460
telephone
number:
(
703)
308
 
8380;
e­
mail
address:
gandhi.
bipin@
epa.
gov.

SUPPLEMENTARY
INFORMATION:

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

You
may
be
potentially
affected
by
this
action
if
you
are
an
agricultural
producer,
food
manufacturer,
pesticide
manufacturer,
or
antimicrobial
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)
 
Antimicrobial
pesticide
(
NAICS
32561)
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
 
0023.
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
In
the
Federal
Register
of
December
6,
2002
(
67
FR
72675)
(
FRL
 
7281
 
9),
EPA
issued
a
notice
pursuant
to
section
408
of
the
FFDCA,
21
U.
S.
C.
346a,
as
amended
by
the
FQPA
(
Public
Law
104
 
170),
announcing
the
filing
of
a
pesticide
petition
3E6523
by
Akzo­
Nobel
Industrial
Specialties,
Inc.,
15200
Almeda
Road,
Houston,
TX
77053.
That
notice
included
a
summary
of
the
petition
prepared
by
the
petitioner.
There
were
no
comments
received
in
response
to
the
notice
of
filing.
The
petition
requested
that
40
CFR
180.960
(
polymers)
be
amended
by
establishing
an
exemption
from
the
requirement
of
a
tolerance
for
residues
of
a­
hydro­
 ­
hydroxypoly
oxyethylene)
C8
 
C18­
alkyl
ether
citrates,
poly(
oxyethylene)
content
is
4
 
12
moles
which
represent
the
following
polymers:
a­
Hydro­
 ­
hydroxypoly
oxyethylene)
C8
alkyl
ether
citrates,
poly(
oxyethylene)
content
is
4
 
12
moles,
minimum
number
average
molecular
weight
(
in
amu)
1,300
(
CAS
Registration
number
330977
 
00
 
9);
a­
Hydro­
 ­
hydroxy­
poly(
oxyethylene)
C10
 
C16­
alkyl
ether
citrates,
poly(
oxyethylene)
content
is
4
 
12
moles,
minimum
number
average
molecular
weight
(
in
amu)
1,100
(
CAS
Registration
number
330985
 
58
 
5);
and
a­
Hydro­
 ­
hydroxy­
poly(
oxyethylene
C16
 
C18­
alkyl
ether
citrates,
poly(
oxyethylene)
content
is
4
 
12
moles,
minimum
number
average
molecular
weight
(
in
amu)
1,300
(
CAS
Registration
number
330985
 
61
 
0).
Section
408(
c)(
2)(
A)(
i)
of
the
FFDCA
allows
EPA
to
establish
an
exemption
from
the
requirement
for
a
tolerance
(
the
legal
limit
for
a
pesticide
chemical
residue
in
or
on
a
food)
only
if
EPA
determines
that
the
tolerance
is
``
safe.''
Section
408(
c)(
2)(
A)(
ii)
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
an
exemption
from
the
requirement
of
a
tolerance
and
to
``
ensure
that
there
is
a
reasonable
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/
Vol.
68,
No.
83
/
Wednesday,
April
30,
2003
/
Rules
and
Regulations
certainty
that
no
harm
will
result
to
infants
and
children
from
aggregate
exposure
to
the
pesticide
chemical
residue.*
*
*''
and
specifies
factors
EPA
is
to
consider
in
establishing
an
exemption.

III.
Inert
Ingredient
Definition
Inert
ingredients
are
all
ingredients
that
are
not
active
ingredients
as
defined
in
40
CFR
153.125
and
include,
but
are
not
limited
to,
the
following
types
of
ingredients
(
except
when
they
have
a
pesticidal
efficacy
of
their
own)
Solvents
such
as
alcohols
and
hydro
carbons;
surfactants
such
as
polyoxyethylene
polymers
and
fatty
acids;
carriers
such
as
clay
and
diatomaceous
earth;
thickeners
such
as
carrageenan
and
modified
cellulose;
wetting,
spreading,
and
dispersing
agents;
propellants
in
aerosol
dispensers;
microencapsulating
agents;
and
emulsifiers.
The
term
``
inert''
is
not
intended
to
imply
nontoxicity;
the
ingredient
may
or
may
not
be
chemically
active.
Generally,
EPA
has
exempted
inert
ingredients
from
the
requirement
of
a
tolerance
based
on
the
low
toxicity
of
the
individual
inert
ingredients.

IV.
Risk
Assessment
and
Statutory
Findings
EPA
establishes
exemptions
from
the
requirement
of
a
tolerance
only
in
those
cases
where
it
can
be
clearly
demonstrated
that
the
risks
from
aggregate
exposure
to
pesticide
chemical
residues
under
reasonably
foreseeable
circumstances
will
pose
no
appreciable
risks
to
human
health.
In
order
to
determine
the
risks
from
aggregate
exposure
to
pesticide
inert
ingredients,
the
Agency
considers
the
toxicity
of
the
inert
in
conjunction
with
possible
exposure
to
residues
of
the
inert
ingredient
through
food,
drinking
water,
and
through
other
exposures
that
occur
as
a
result
of
pesticide
use
in
residential
settings.
If
EPA
is
able
to
determine
that
a
finite
tolerance
is
not
necessary
to
ensure
that
there
is
a
reasonable
certainty
that
no
harm
will
result
from
aggregate
exposure
to
the
inert
ingredient,
an
exemption
from
the
requirement
of
a
tolerance
may
be
established.
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
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.
In
the
case
of
certain
chemical
substances
that
are
defined
as
polymers,
the
Agency
has
established
a
set
of
criteria
to
identify
categories
of
polymers
that
should
present
minimal
or
no
risk.
The
definition
of
a
polymer
is
given
in
40
CFR
723.250(
b).
The
following
exclusion
criteria
for
identifying
these
low
risk
polymers
are
described
in
40
CFR
723.250(
d).
1.
The
polymer,
a­
hydro­
 ­
hydroxypoly(
oxyethylene)
C8­
C18­
alkyl
ether
citrates,
poly(
oxyethylene)
content
is
4
 
12
moles,
is
not
a
cationic
polymer
nor
is
it
reasonably
anticipated
to
become
a
cationic
polymer
in
a
natural
aquatic
environment.
2.
The
polymer
does
contain
as
an
integral
part
of
its
composition
the
atomic
elements
carbon,
hydrogen,
and
oxygen.
3.
The
polymer
does
not
contain
as
an
integral
part
of
its
composition,
except
as
impurities,
any
element
other
than
those
listed
in
40
CFR
723.250(
d)(
2)(
ii).
4.
The
polymer
is
neither
designed
nor
can
it
be
reasonably
anticipated
to
substantially
degrade,
decompose,
or
depolymerize.
5.
The
polymer
is
manufactured
or
imported
from
monomers
and/
or
reactants
that
are
already
included
on
the
TSCA
Chemical
Substance
Inventory
or
manufactured
under
an
applicable
TSCA
section
5
exemption.
6.
The
polymer
is
not
a
water
absorbing
polymer
with
a
number
average
molecular
weight
(
MW)
greater
than
or
equal
to
10,000
daltons.
Additionally,
the
polymer,
a­
hydro­
 ­
hydroxypoly(
oxyethylene)
C8­
C18­
alkyl
ether
citrates,
poly(
oxyethylene)
content
is
4
 
12
moles,
also
meets
as
required
the
following
exemption
criteria
specified
in
40
CFR
723.250(
e).
7.
The
polymer's
minimum
number
average
MW
of
1,100
is
greater
than
1,000
and
less
than
10,000
daltons.
The
polymer
contains
less
than
10%
oligomeric
material
below
MW
500
and
less
than
25%
oligomeric
material
below
MW
1,000,
and
the
polymer
does
not
contain
any
reactive
functional
groups.
Thus,
a­
hydro­
 ­
hydroxypoly(
oxyethylene)
C8­
C18­
alkyl
ether
citrates,
poly(
oxyethylene)
content
is
4
 
2
moles
meet
all
the
criteria
for
a
polymer
to
be
considered
low
risk
under
40
CFR
723.250.
Based
on
its
conformance
to
the
above
criteria,
no
mammalian
toxicity
is
anticipated
from
dietary,
inhalation,
or
dermal
exposure
to
a­
hydro­
 ­
hydroxypoly(
oxyethylene)
C8­
C18­
alkyl
ether
citrates,
poly(
oxyethylene)
content
is
4
 
12
moles.
V.
Aggregate
Exposures
For
the
purposes
of
assessing
potential
exposure
under
this
exemption,
EPA
considered
that
ahydro
 ­
hydroxypoly(
oxyethylene)
C8­
C18­
alkyl
ether
citrates,
poly(
oxyethylene)
content
is
4
 
12
moles
could
be
present
in
all
raw
and
processed
agricultural
commodities
and
drinking
water,
and
that
nonoccupational
non­
dietary
exposure
was
possible.
The
number
average
MW
of
ahydro
 ­
hydroxypoly(
oxyethylene)
C8­
C18­
alkyl
ether
citrates,
poly(
oxyethylene)
content
is
4
 
12
moles
is
1,100
daltons.
Generally,
a
polymer
of
this
size
would
be
poorly
absorbed
through
the
intact
gastrointestinal
tract
or
through
intact
human
skin.
Since
ahydro
 ­
hydroxypoly(
oxyethylene)
C8­
C18­
alkyl
ether
citrates
poly(
oxyethylene)
content
is
4
 
12
moles
conform
to
the
criteria
that
identify
a
low
risk
polymer,
there
are
no
concerns
for
risks
associated
with
any
potential
exposure
scenarios
that
are
reasonably
foreseeable.
The
Agency
has
determined
that
a
tolerance
is
not
necessary
to
protect
the
public
health.

VI.
Cumulative
Effects
Section
408(
b)(
2)(
D)(
v)
of
the
FFDCA
requires
that,
when
considering
whether
to
establish,
modify,
or
revoke
a
tolerance
or
tolerance
exemption,
the
Agency
consider
``
available
information''
concerning
the
cumulative
effects
of
a
particular
chemical's
residues
and
``
other
substances
that
have
a
common
mechanism
of
toxicity.''
The
Agency
has
not
made
any
conclusions
as
to
whether
or
not
ahydro
 ­
hydroxypoly(
oxyethylene)
C8­
C18­
alkyl
ether
citrates,
poly(
oxyethylene)
content
is
4
 
12
moles
share
a
common
mechanism
of
toxicity
with
any
other
chemicals.
However,
ahydro
 ­
hydroxypoly(
oxyethylene)
C8­
C18­
alkyl
ether
citrates,
poly(
oxyethylene)
content
is
4
 
12
conform
to
the
criteria
that
identify
a
low
risk
polymer.
Due
to
the
expected
lack
of
toxicity
based
on
the
above
conformance,
the
Agency
has
determined
that
a
cumulative
risk
assessment
is
not
necessary.

VII.
Determination
of
Safety
for
U.
S.
Population
Based
on
the
conformance
to
the
criteria
used
to
identify
a
low
risk
polymer,
EPA
concludes
that
there
is
a
reasonable
certainty
of
no
harm
to
the
U.
S.
population
from
aggregate
exposure
to
residues
of
a­
hydro­
 ­
hydroxypoly(
oxyethylene)
C8­
C18­
alkyl
ether
citrates,
poly(
oxyethylene)
content
is
4
 
12
moles.

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/
Vol.
68,
No.
83
/
Wednesday,
April
30,
2003
/
Rules
and
Regulations
VIII.
Determination
of
Safety
for
Infants
and
Children
FFDCA
section
408
of
the
FFDCA
provides
that
EPA
shall
apply
an
additional
tenfold
margin
of
safety
for
infants
and
children
in
the
case
of
threshold
effects
to
account
for
prenatal
and
postnatal
toxicity
and
the
completeness
of
the
data
base
unless
EPA
concludes
that
a
different
margin
safety
will
be
safe
for
infants
and
children.
Due
to
the
expected
low
toxicity
of
a­
hydro­
 ­
hydroxypoly(
oxyethylene)
C8­
C18­
alkyl
ether
citrates,
poly(
oxyethylene)
content
is
4
 
12
moles,
EPA
has
not
used
a
safety
factor
analysis
to
assess
the
risk.
For
the
same
reasons
the
additional
tenfold
safety
factor
is
unnecessary.

IX.
Other
Considerations
A.
Endocrine
Disruptors
There
is
no
available
evidence
that
ahydro
 ­
hydroxypoly(
oxyethylene)
C8­
C18­
alkyl
ether
citrates,
poly(
oxyethylene)
content
is
4
 
12
moles
is
an
endocrine
disruptor.

B.
Analytical
Enforcement
Methodology
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.
International
Tolerances
The
Agency
is
not
aware
of
any
country
requiring
a
tolerance
for
ahydro
 ­
hydroxypoly(
oxyethylene)
C8­
C18­
alkyl
ether
citrates,
poly(
oxyethylene)
content
is
4
 
12
moles
nor
have
any
CODEX
Maximum
Residue
Levels
been
established
for
any
food
crops
at
this
time.

X.
Conclusion
Accordingly,
EPA
finds
that
exempting
residues
of
a­
hydro­
 ­
hydroxypoly(
oxyethylene)
C8­
C18­
alkyl
ether
citrates,
poly(
oxyethylene)
content
is
4
 
12
moles
from
the
requirement
of
a
tolerance
will
be
safe.

XI.
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.
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
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
 
0023
in
the
subject
line
on
the
first
page
of
your
submission.
All
requests
must
be
in
writing,
and
must
be
mailed
or
delivered
to
the
Hearing
Clerk
on
or
before
June
30,
2003.
1.
Filing
the
request.
Your
objection
must
specify
the
specific
provisions
in
the
regulation
that
you
object
to,
and
the
grounds
for
the
objections
(
40
CFR
178.25).
If
a
hearing
is
requested,
the
objections
must
include
a
statement
of
the
factual
issues(
s)
on
which
a
hearing
is
requested,
the
requestor's
contentions
on
such
issues,
and
a
summary
of
any
evidence
relied
upon
by
the
objector
(
40
CFR
178.27).
Information
submitted
in
connection
with
an
objection
or
hearing
request
may
be
claimed
confidential
by
marking
any
part
or
all
of
that
information
as
CBI.
Information
so
marked
will
not
be
disclosed
except
in
accordance
with
procedures
set
forth
in
40
CFR
part
2.
A
copy
of
the
information
that
does
not
contain
CBI
must
be
submitted
for
inclusion
in
the
public
record.
Information
not
marked
confidential
may
be
disclosed
publicly
by
EPA
without
prior
notice.
Mail
your
written
request
to:
Office
of
the
Hearing
Clerk
(
1900C),
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460
 
0001.
You
may
also
deliver
your
request
to
the
Office
of
the
Hearing
Clerk
in
Rm.
104,
Crystal
Mall
#
2,
1921
Jefferson
Davis
Hwy.,
Arlington,
VA.
The
Office
of
the
Hearing
Clerk
is
open
from
8
a.
m.
to
4
p.
m.,
Monday
through
Friday,
excluding
legal
holidays.
The
telephone
number
for
the
Office
of
the
Hearing
Clerk
is
(
703)
603
 
0061.
2.
Tolerance
fee
payment.
If
you
file
an
objection
or
request
a
hearing,
you
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
XI.
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
 
0023,
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
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/
Vol.
68,
No.
83
/
Wednesday,
April
30,
2003
/
Rules
and
Regulations
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).

XII.
Statutory
and
Executive
Order
Reviews
This
final
rule
establishes
an
exemption
from
the
tolerance
requirement
under
section
408(
d)
of
the
FFDCA
in
response
to
a
petition
submitted
to
the
Agency.
The
Office
of
Management
and
Budget
(
OMB)
has
exempted
these
types
of
actions
from
review
under
Executive
Order
12866,
entitled
Regulatory
Planning
and
Review
(
58
FR
51735,
October
4,
1993).
Because
this
rule
has
been
exempted
from
review
under
Executive
Order
12866
due
to
its
lack
of
significance,
this
rule
is
not
subject
to
Executive
Order
13211,
Actions
Concerning
Regulations
That
Significantly
Affect
Energy
Supply,
Distribution,
or
Use
(
66
FR
28355,
May
22,
2001).
This
final
rule
does
not
contain
any
information
collections
subject
to
OMB
approval
under
the
Paperwork
Reduction
Act
(
PRA),
44
U.
S.
C.
3501
et
seq.,
or
impose
any
enforceable
duty
or
contain
any
unfunded
mandate
as
described
under
Title
II
of
the
Unfunded
Mandates
Reform
Act
of
1995
(
Public
Law
104
 
4).
Nor
does
it
require
any
special
considerations
under
Executive
Order
12898,
entitled
Federal
Actions
to
Address
Environmental
Justice
in
Minority
Populations
and
Low­
Income
Populations
(
59
FR
7629,
February
16,
1994);
or
OMB
review
or
any
Agency
action
under
Executive
Order
13045,
entitled
Protection
of
Children
from
Environmental
Health
Risks
and
Safety
Risks
(
62
FR
19885,
April
23,
1997).
This
action
does
not
involve
any
technical
standards
that
would
require
Agency
consideration
of
voluntary
consensus
standards
pursuant
to
section
12(
d)
of
the
National
Technology
Transfer
and
Advancement
Act
of
1995
(
NTTAA),
Public
Law
104
 
113,
section
12(
d)
(
15
U.
S.
C.
272
note).
Since
tolerances
and
exemptions
that
are
established
on
the
basis
of
a
petition
under
section
408(
d)
of
the
FFDCA,
such
as
the
exemption
in
this
final
rule,
do
not
require
the
issuance
of
a
proposed
rule,
the
requirements
of
the
Regulatory
Flexibility
Act
(
RFA)
(
5
U.
S.
C.
601
et
seq.)
do
not
apply.
In
addition,
the
Agency
has
determined
that
this
action
will
not
have
a
substantial
direct
effect
on
States,
on
the
relationship
between
the
national
government
and
the
States,
or
on
the
distribution
of
power
and
responsibilities
among
the
various
levels
of
government,
as
specified
in
Executive
Order
13132,
entitled
Federalism
(
64
FR
43255,
August
10,
1999).
Executive
Order
13132
requires
EPA
to
develop
an
accountable
process
to
ensure
``
meaningful
and
timely
input
by
State
and
local
officials
in
the
development
of
regulatory
policies
that
have
federalism
implications.''
``
Policies
that
have
federalism
implications''
is
defined
in
the
Executive
Order
to
include
regulations
that
have
``
substantial
direct
effects
on
the
States,
on
the
relationship
between
the
national
government
and
the
States,
or
on
the
distribution
of
power
and
responsibilities
among
the
various
levels
of
government.''
This
final
rule
directly
regulates
growers,
food
processors,
food
handlers
and
food
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.

XIII.
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
rule
in
the
Federal
Register.
This
rule
is
not
a
``
major
rule''
as
defined
by
5
U.
S.
C.
804(
2).

List
of
Subjects
in
40
CFR
Part
180
Environmental
protection,
Administrative
practice
and
procedure,
Agricultural
commodities,
Pesticides
and
pests,
Reporting
and
recordkeeping
requirements.

Dated:
April
17,
2003.
Peter
Caulkins,
Acting
Director,
Registration
Division,
Office
of
Pesticide
Programs.

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

PART
180
 
[
AMENDED]

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

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


2.
Section
180.960
is
amended
by
adding
alphabetically
the
following
inert
ingredients
to
the
table
to
read
as
follows

§
180.960
Polymer;
exemptions
from
the
requirement
of
a
tolerance.

*
*
*
*
*

Polymers
CAS
No.

*
*
*
*
*
a­
Hydro­
 ­
hydroxy­
poly(
oxyethylene)
C8
alkyl
ether
citrates,
poly(
oxyethylene)
content
is
4
 
12
moles,
minimum
number
average
molecular
weight
(
in
amu)
1,300
................................................................
330977
 
00
 
9
a­
Hydro­
 ­
hydroxy­
poly(
oxyethylene)
C10
 
C16­
alkyl
ether
citrates,
poly(
oxyethylene)
content
is
4
 
12
moles,
minimum
number
average
molecular
weight
(
in
amu)
1,100
....................................................
330985
 
58
 
5
a­
Hydro­
 ­
hydroxy­
poly(
oxyethylene)
C16
 
C18­
alkyl
ether
citrates,
poly(
oxyethylene)
content
is
4
 
12
moles,
minimum
number
average
molecular
weight
(
in
amu)
1,300
....................................................
330985
 
61
 
0
*
*
*
*
*

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23073
Federal
Register
/
Vol.
68,
No.
83
/
Wednesday,
April
30,
2003
/
Rules
and
Regulations
[
FR
Doc.
03
 
10262
Filed
4
 
29
 
03;
8:
45
a.
m.]

BILLING
CODE
6560
 
50
 
S
ENVIRONMENTAL
PROTECTION
AGENCY
40
CFR
Part
180
[
OPP
 
2003
 
0147;
FRL
 
7302
 
4]

Bacillus
thuringiensis
Cry1F
Protein
in
Cotton;
Temporary
Exemption
from
the
Requirement
of
a
Tolerance
AGENCY:
Environmental
Protection
Agency
(
EPA).
ACTION:
Final
rule.

SUMMARY:
This
regulation
establishes
a
temporary
exemption
from
the
requirement
of
a
tolerance
for
residues
of
the
Bacillus
thuringiensis
Cry1F
protein
in
cotton
when
applied/
used
as
a
plant­
incorporated
protectant.
Mycogen
Seeds,
c/
o
Dow
AgroSciences
LLC,
submitted
a
petition
to
EPA
under
the
Federal
Food,
Drug,
and
Cosmetic
Act
(
FFDCA),
as
amended
by
the
Food
Quality
Protection
Act
of
1996
(
FQPA),
requesting
the
temporary/
tolerance
exemption.
This
regulation
eliminates
the
need
to
establish
a
maximum
permissible
level
for
residues
of
Bacillus
thuringiensis
Cry1F
protein
in
cotton.
The
temporary
tolerance
exemption
will
expire
on
May
1,
2004.
DATES:
This
regulation
is
effective
April
30,
2003.
Objections
and
requests
for
hearings,
identified
by
docket
ID
number
OPP
 
2003
 
0147,
must
be
received
by
EPA
on
or
before
June
30,
2003.
ADDRESSES:
Written
objections
and
hearing
requests
may
be
submitted
electronically,
by
mail,
or
through
hand
delivery/
courier.
Follow
the
detailed
instructions
as
provided
in
Unit
VIII.
of
the
SUPPLEMENTARY
INFORMATION.
FOR
FURTHER
INFORMATION
CONTACT:
Leonard
Cole,
Biopesticides
and
Pollution
Prevention
Division
(
7511C),
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460
 
0001;
telephone
number:
(
703)
305
 
5412;
e­
mail
address:
cole.
leonard@
epa.
gov.

SUPPLEMENTARY
INFORMATION:

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

You
may
be
affected
by
this
action
if
you
are
an
agricultural
producer,
food
manufacturer,
or
pesticide
manufacturer.
Potentially
affected
categories
and
entities
may
include,
but
are
not
limited
to
 
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
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
 
0147.
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
In
the
Federal
Register
of
October
9,
2002
(
67
FR
62971)
(
FRL
 
7196
 
2),
EPA
issued
a
notice
pursuant
to
section
408
of
the
FFDCA,
21
U.
S.
C.
346a,
as
amended
by
FQPA
(
Public
Law
104
 
170),
announcing
the
filing
of
a
pesticide
tolerance
petition
(
PP
2G6494)
by
Mycogen
Seeds,
c/
o
Dow
AgroSciences
LLC,
9330
Zionsville
Road,
Indianapolis,
IN
46268
 
1054.
This
notice
included
a
summary
of
the
petition
prepared
by
the
petitioner
Mycogen
Seeds,
c/
o
Dow
AgroSciences
LLC.
Comments
were
received
in
response
to
the
notice
of
filing.
These
comments
were
from
grower
groups,
state
agencies,
and
academia.
All
comments
were
in
support
of
the
registration
of
Dow
AgroSciences'
stacked
gene
plant­
incorporated
protectant.
The
petition
requested
that
40
CFR
part
180
be
amended
by
establishing
a
temporary
exemption
from
the
requirement
of
a
tolerance
for
residues
of
Bacillus
thuringiensis
Cry1F
protein
and
the
genetic
material
necessary
for
its
production
in
cotton.
New
section
408(
c)(
2)(
A)(
i)
of
the
FFDCA
allows
EPA
to
establish
an
exemption
from
the
requirement
for
a
tolerance
(
the
legal
limit
for
a
pesticide
chemical
residue
in
or
on
a
food)
only
if
EPA
determines
that
the
exemption
is
``
safe.''
Section
408(
c)(
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.
*
*
*''
Additionally,
section
408(
b)(
2)(
D)
of
the
FFDCA
requires
that
the
Agency
consider
``
available
information
concerning
the
cumulative
effects
of
a
particular
pesticide's
residues
and
``
other
substances
that
have
a
common
mechanism
of
toxicity.''
EPA
performs
a
number
of
analyses
to
determine
the
risks
from
aggregate
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