Document ID: EPA-HQ-OPP-2006-0551-0002
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2006-07-26T04:00Z

FILE
NAME:
Reg.:
polymer.
wpt
(
1/
1/
2006)(
xml)
Template
Number
P18
ATTENTION:

All
commodity
terms
must
comply
with
the
Food
and
Feed
Commodity
Vocabulary
database
(
http://
www.
epa.
gov/
pesticides/
foodfeed/).

All
text
in
blue
font
(
instructions
for
preparing
the
document),
should
be
removed
prior
to
sending
the
document
to
the
Federal
Register
Staff.
Instructional
text
and
prompts
in
green
font
should
also
be
removed.

ENVIRONMENTAL
PROTECTION
AGENCY
40
CFR
Part
180
[
EPA­
HQ­
OPP­
2006­[
insert
Docket
ID
no.];
FRL­
XXXX­
X]

[
Note:
Get
your
docket
identification
(
ID)
number
from
the
Docket
Manager
(
see
OPPTS
Interim
Guidance
for
implementing
regulations.
gov).
You
get
the
FRL
number
from
the
FRS
when
the
document
is
sent
for
editing
and
coding.]

RIN
[
XXXX]­[
XXXX]

[
Note:
If
rule
related,
insert
appropriate
Regulatory
Identification
Number
(
RIN),
which
you
can
get
from
the
Unified
Regulatory
Agenda
or
your
regulatory
contact.]

[
2H­
Azepin­
2­
one,
1­
Ethenylhexahydro­,
Homopolymer
I];
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
[
2H­
azepin­
2­
one,
1­
ethenylhexahydro­,
homopolymer
];
when
used
as
an
inert
ingredient
in
a
pesticide
chemical
formulation
[
BASF
AG]
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
[
2Hazepin
2­
one,
1­
ethenylhexahydro­,
homopolymer
].
2
DATES:
This
regulation
is
effective
[
insert
date
of
publication
in
the
Federal
Register].
Objections
and
requests
for
hearings
must
be
received
on
or
before
[
insert
date
60
days
after
date
of
publication
in
the
Federal
Register],
and
must
be
filed
in
accordance
with
the
instructions
provided
in
40
CFR
part
178
(
see
also
Unit
I.
C.
of
the
SUPPLEMENTARY
INFORMATION).

ADDRESSES:
EPA
has
established
a
docket
for
this
action
under
docket
identification
(
ID)
number
EPA­
HQ­
OPP­
2006­[
insert
docket
ID
no.].
All
documents
in
the
docket
are
listed
in
the
index
for
the
docket.
Although
listed
in
the
index,
some
information
is
not
publicly
available,
e.
g.,
Confidential
Business
Information
(
CBI)
or
other
information
whose
disclosure
is
restricted
by
statute.
Certain
other
material,
such
as
copyrighted
material,
is
not
placed
on
the
Internet
and
will
be
publicly
available
only
in
hard
copy
form.
Publicly
available
docket
materials
are
available
in
the
electronic
docket
at
http://
www.
regulations.
gov,
or,
if
only
available
in
hard
copy,
at
the
OPP
Regulatory
Public
Docket
in
Rm.
S­
4400,
One
Potomac
Yard
(
South
Building),
2777
S.
Crystal
Drive,
Arlington,
VA.
The
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.

FOR
FURTHER
INFORMATION
CONTACT:[
Bipin
Gandhi],
Registration
Division
(
7505P),
Office
of
Pesticide
Programs,
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460­
0001;
telephone
number:
[
703­
308­
8380];
e­
mail
address:[
gandhi.
bipin]@
epa.
gov.

SUPPLEMENTARY
INFORMATION:

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

You
may
be
potentially
affected
by
this
action
if
you
are
an
agricultural
producer,
food
manufacturer,
or
pesticide
manufacturer.
Potentially
affected
entities
may
include,
but
are
not
limited
to:

°
Crop
production
(
NAICS
code
111)

°
Animal
production
(
NAICS
code
112)

°
Food
manufacturing
(
NAICS
code
311)

°
Pesticide
manufacturing
(
NAICS
code
32532)
3
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.
To
determine
whether
you
or
your
business
may
be
affected
by
this
action,
you
should
carefully
examine
the
applicability
provisions
in
[
insert
appropriate
cite
to
either
another
unit
in
the
preamble
or
a
section
in
a
rule].
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
Access
Electronic
Copies
of
this
Document?

In
addition
to
accessing
an
electronic
copy
of
this
Federal
Register
document
through
the
electronic
docket
at
http://
www.
regulations.
gov,
you
may
access
this
"
Federal
Register"
document
electronically
through
the
EPA
Internet
under
the
"
Federal
Register"
listings
at
http://
www.
epa.
gov/
fedrgstr.
You
may
also
access
a
frequently
updated
electronic
version
of
40
CFR
part
180
through
the
Government
Printing
Office's
pilot
e­
CFR
site
at
http://
www.
gpoaccess.
gov/
ecfr.

C.
Can
I
File
an
Objection
or
Hearing
Request?

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.
You
must
file
your
objection
or
request
a
hearing
on
this
regulation
in
accordance
with
the
instructions
provided
in
40
CFR
part
178.
To
ensure
proper
receipt
by
EPA,
you
must
identify
docket
ID
number
EPA­
HQ­
OPP­
2006­[
insert
docket
ID
no.]
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
[
insert
date
60
days
after
date
of
publication
in
the
Federal
Register].

In
addition
to
filing
an
objection
or
hearing
request
with
the
Hearing
Clerk
as
described
in
40
CFR
part
178,
please
submit
a
copy
of
the
filing
that
does
not
contain
any
CBI
for
inclusion
in
the
public
docket
that
is
described
in
ADDRESSES.
Information
not
marked
confidential
pursuant
to
40
CFR
part
2
may
be
disclosed
publicly
by
EPA
without
prior
notice.
Submit
your
copies,
identified
by
docket
ID
number
EPA­
HQ­
OPP­
2006­[
insert
docket
ID
no.],
by
one
of
the
following
methods.

°
Federal
eRulemaking
Portal:
http://
www.
regulations.
gov.
Follow
the
on­
line
instructions
for
submitting
comments.

°
Mail:
Office
of
Pesticide
Programs
(
OPP)
Regulatory
Public
Docket
(
7502P),
4
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460­
0001.

°
Delivery:
OPP
Regulatory
Public
Docket
(
7502P),
Environmental
Protection
Agency,
Rm.
S­
4400,
One
Potomac
Yard
(
South
Building),
2777
S.
Crystal
Drive,
Arlington,
VA.
Deliveries
are
only
accepted
during
the
Docket's
normal
hours
of
operation
(
8:
30
a.
m.
to
4
p.
m.,
Monday
through
Friday,
excluding
legal
holidays).
Special
arrangements
should
be
made
for
deliveries
of
boxed
information.
The
Docket
telephone
number
is
(
703)
305­
5805.

II.
Background
and
Statutory
Findings
In
the
Federal
Register
of
[
March
1,
2006]
([
71]
FR
[
10505])
(
FRL­
7762­
2),
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
(
PP
[
6E7026])
by
[
BASF
AG],
[
67052
Ludwigshafen,
Germany].
The
petition
requested
that
40
CFR
180.960
be
amended
by
establishing
an
exemption
from
the
requirement
of
a
tolerance
for
residues
of
[
2Hazepin
2­
one,
1­
ethenylhexahydro­,
homopolymer
];
[
insert
CAS
Reg.
No.
25189­
83­
7].
That
notice
included
a
summary
of
the
petition
prepared
by
the
petitioner.
There
were
no
comments
in
response
to
the
notice
of
filing].

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
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
hydrocarbons;
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.
5
IV.
Risk
Assessment
and
Statutory
Findings
EPA
establishes
exemptions
from
the
requirement
of
a
tolerance
only
in
those
cases
where
it
can
be
shown
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,
[
2H­
azepin­
2­
one,
1­
ethenylhexahydro­,
homopolymer
],
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,
[
2H­
azepin­
2­
one,
1­
ethenylhexahydro­,
homopolymer],
also
meets
as
required
the
following
exemption
criteria
specified
in
40
CFR
723.250(
e).
6
7.
The
polymer's
number
average
molecular
weight
(
MW)
of
[
4500]
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,
[
2H­
azepin­
2­
one,
1­
ethenylhexahydro­,
homopolymer
]
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
[
2H­
azepin­
2­
one,
1­
ethenylhexahydro­,
homopolymer
].

V.
Aggregate
Exposures
For
the
purposes
of
assessing
potential
exposure
under
this
exemption,
EPA
considered
that
[
2H­
azepin­
2­
one,
1­
ethenylhexahydro­,
homopolymer
]
could
be
present
in
all
raw
and
processed
agricultural
commodities
and
drinking
water,
and
that
non­
occupational
non­
dietary
exposure
was
possible.
The
number
average
MW
of
[
2H­
azepin­
2­
one,
1­
ethenylhexahydro­,
homopolymer
]
is
[
4500]
daltons.
Generally,
a
polymer
of
this
size
would
be
poorly
absorbed
through
the
intact
gastrointestinal
tract
or
through
intact
human
skin.
Since
[
2H­
azepin­
2­
one,
1­
ethenylhexahydro­,
homopolymer
]
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
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."
EPA
does
not
have,
at
this
time,
available
data
to
determine
whether
[
2H­
azepin­
2­
one,
1­
ethenylhexahydro­,
homopolymer
]
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
[
2H­
azepin­
2­
one,
1­
ethenylhexahydro­,
homopolymer
]
and
any
other
substances
and
[
2H­
azepin­
2­
one,
1­
ethenylhexahydro­,
homopolymer
]
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
[
2H­
azepin­
2­
one,
1­
ethenylhexahydro­,
homopolymer
]
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
at
http://
www.
epa.
gov/
pesticides/
cumulative.
7
VII.
Additional
Safety
Factor
for
the
Protection
of
Infants
and
Children
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
of
safety
will
be
safe
for
infants
and
children.
Due
to
the
expected
low
toxicity
of
[
2H­
azepin­
2­
one,
1­
ethenylhexahydro­,
homopolymer
],
EPA
has
not
used
a
safety
factor
analysis
to
assess
the
risk.
For
the
same
reasons
the
additional
tenfold
safety
factor
is
unnecessary.

VIII.
Determination
of
Safety
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,
including
infants
and
children,
from
aggregate
exposure
to
residues
of
[
2H­
azepin­
2­
one,
1­
ethenylhexahydro­,
homopolymer
].

IX.
Other
Considerations
A.
Endocrine
Disruptors
There
is
no
available
evidence
that
[
2H­
azepin­
2­
one,
1­
ethenylhexahydro­,
homopolymer
]
is
an
endocrine
disruptor.

B.
Existing
Exemptions
from
a
Tolerance
C.
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.

D.
International
Tolerances
The
Agency
is
not
aware
of
any
country
requiring
a
tolerance
for
[
2H­
azepin­
2­
one,
1­
ethenylhexahydro­,
homopolymer
]
nor
have
any
CODEX
Maximum
Residue
Levels
(
MRLs)
been
established
for
any
food
crops
at
this
time.

X.
Conclusion
Accordingly,
EPA
finds
that
exempting
residues
of
[
2H­
azepin­
2­
one,
1­
ethenylhexahydro­,
homopolymer
]
from
the
requirement
of
a
tolerance
will
be
safe.

XI.
Statutory
and
Executive
Order
Reviews
This
final
rule
establishes
an
exemption
from
the
tolerance
requirement
under
section
8
408(
d)
of
the
FFDCA
in
response
to
a
petition
submitted
to
the
Agency.
The
Office
of
Management
and
Budget
(
OMB)
has
exempted
these
types
of
actions
from
review
under
Executive
Order
12866,
entitled
Regulatory
Planning
and
Review
(
58
FR
51735,
October
4,
1993).
Because
this
rule
has
been
exempted
from
review
under
Executive
Order
12866
due
to
its
lack
of
significance,
this
rule
is
not
subject
to
Executive
Order
13211,
Actions
Concerning
Regulations
That
Significantly
Affect
Energy
Supply,
Distribution,
or
Use
(
66
FR
28355,
May
22,
2001).
This
final
rule
does
not
contain
any
information
collections
subject
to
OMB
approval
under
the
Paperwork
Reduction
Act
(
PRA),
44
U.
S.
C.
3501
et
seq.,
or
impose
any
enforceable
duty
or
contain
any
unfunded
mandate
as
described
under
Title
II
of
the
Unfunded
Mandates
Reform
Act
of
1995
(
UMRA)
(
Public
Law
104­
4).
Nor
does
it
require
any
special
considerations
under
Executive
Order
12898,
entitled
Federal
Actions
to
Address
Environmental
Justice
in
Minority
Populations
and
Low­
Income
Populations
(
59
FR
7629,
February
16,
1994);
or
OMB
review
or
any
Agency
action
under
Executive
Order
13045,
entitled
Protection
of
Children
from
Environmental
Health
Risks
and
Safety
Risks
(
62
FR
19885,
April
23,
1997).
This
action
does
not
involve
any
technical
standards
that
would
require
Agency
consideration
of
voluntary
consensus
standards
pursuant
to
section
12(
d)
of
the
National
Technology
Transfer
and
Advancement
Act
of
1995
(
NTTAA),
Public
Law
104­
113,
section
12(
d)
(
15
U.
S.
C.
272
note).
Since
tolerances
and
exemptions
that
are
established
on
the
basis
of
a
petition
under
section
408(
d)
of
the
FFDCA,
such
as
the
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.
[
If
this
rule
is
adopting
a
proposed
rule
add
the
following
sentence.]
The
Agency
hereby
certifies
that
this
rule
will
not
have
significant
negative
economic
impact
on
a
substantial
number
of
small
entities.
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
9
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.

XII.
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:_____________

____________________________________

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),
346a
and
371
2.
In
§
180.960
the
table
is
amended
by
[
adding
alphabetically]
polymer
to
read
as
follows:

§
180.960
Polymers;
exemptions
from
the
requirement
of
a
tolerance.
10
*
*
*
*
*

Polymer
CAS
No.
<

*
*
*

[
2H­
Azepin­
2­
one,
1­
ethenylhexahydro­,
homopolymer]

*
*
*
*
*

[
CAS
Reg.
No.
25189­
83­
7]

*
*

[
FR
Doc.
06­??????
Filed
??­??­
06;
8:
45
am]
BILLING
CODE
6560­
50­
S