Document ID: EPA-HQ-OPP-2002-0294-0001
Agency: epa
Document Type: Notice
Title: Alpha-Cyclodextrin, Beta-Cyclodextrin, and Gamma-Cyclodextrin; Notice of FIling a Pesticide Petition 
to Establish an Exemption from the Requirement of a Toleranc
Posted Date: 2002-11-14T05:00Z

69003
Federal
Register
/
Vol.
67,
No.
220
/
Thursday,
November
14,
2002
/
Notices
test
systems
and
other
scientifically
relevant
information,
to
determine
whether
certain
substances
may
have
hormonal
effects
in
humans.
In
1996,
EPA
chartered
a
scientific
advisory
committee,
the
Endocrine
Disruptor
Screening
and
Testing
Advisory
Committee
(
EDSTAC),
under
the
authority
of
the
Federal
Advisory
Committee
Act
(
FACA
)
to
advise
it
on
establishing
a
program
to
carry
out
Congress'
directive.
EDSTAC
recommended
a
multi­
step
approach
including
a
series
of
screens
(
Tier
I
Screens)
and
tests
(
Tier
II
Tests)
for
determining
whether
a
chemical
substance
may
have
an
effect
similar
to
that
produced
by
naturally
occurring
hormones.
EPA
adopted
many
of
EDSTAC's
recommendations
in
the
program
that
it
developed,
the
EDSP,
to
carry
out
Congress'
directive.
EDSTAC
also
recognized
that
there
currently
are
no
validated
testing
systems
for
determining
whether
a
chemical
may
have
an
effect
in
humans
that
is
similar
to
an
effect
produced
by
naturally
occurring
hormones.
Consequently,
EPA
is
in
the
process
of
developing
and
validating
the
screens
and
tests
that
EDSTAC
recommended
for
inclusion
in
the
EDSP.
In
carrying
out
this
validation
exercise,
EPA
is
working
closely
with,
and
adhering
to
the
principles
of
the
Interagency
Coordinating
Committee
for
the
Validation
of
Alternate
Methods
(
ICCVAM).
EPA
also
is
working
closely
with
the
Organization
for
Economic
Cooperation
and
Development's
(
OECD)
Endocine
Testing
and
Assessment
Task
Force
to
validate
and
harmonize
endocrine
screening
tests
of
international
interest.
Finally,
to
ensure
that
EPA
has
the
best
and
most
up­
to­
date
advice
available
regarding
the
validation
of
the
screens
and
tests
in
the
EDSP,
EPA
recently
chartered
EDMVS
of
the
NACEPT.
EDMVS
provides
independent
advice
and
counsel
to
the
Agency
through
NACEPT,
on
scientific
and
technical
issues
related
to
validation
of
the
EDSP
Tier
I
screens
and
Tier
II
tests,
including
advice
on
methods
for
reducing
animal
use,
refining
procedures
involving
animals
to
make
them
less
stressful,
and
replacing
animals
where
scientifically
appropriate.
EDMVS
has
met
five
times
since
its
establishment
in
September
2001.
The
objectives
of
the
October
2001
meeting
(
docket
control
number
OPPTS
 
42212D)
were
for
EPA
to
provide:
1.
An
overview
of
EPA's
EDSP.
2.
Background
information
on
test
protocol
validation
and
approaches.
3.
For
the
EDMVS
to
develop
a
clear
understanding
of
their
scope,
purpose
and
operating
procedures.
4.
For
the
EDMVS
and
the
EDSP
to
determine
the
next
steps.
The
objectives
of
the
December
2001
meeting
(
docket
control
number
OPPTS
 
42212E)
were
for
the
EDMVS
to
provide
input
and
advice
on:
1.
EDMVS's
mission
statement
and
work
plan.
2.
The
in
utero
through
lactation
assay
detailed
review
paper.
3.
The
pubertal
assay
study
design
for
the
multi­
dose
and
chemical
array
protocols.
4.
The
mammalian
1­
generation
study
design.
The
objectives
of
the
March
2002
meeting
(
docket
control
number
OPPTS
 
42212F)
were
for
the
EDMS
to
provide
input
and
advice
on:
1.
EDSP's
implementation
process
and
practical
aspects
of
validation.
2.
The
in
utero
through
lactation
assay
protocol.
3.
The
fish
reproduction
assay
detailed
review
paper.
4.
Special
studies
on
fathead
minnow
assays,
vitellogenin
assay,
and
avian
dosing
protocol.
5.
The
steroidogenesis
detailed
review
paper.
6.
The
aromatase
detailed
review
paper.
7.
A
proposed
standard
suite
of
chemicals
for
testing
in
the
Tier
I
screening
assay.
8.
The
current
efforts
related
to
evaluating
the
relevance
of
animal
data
to
human
health.
9.
EPA's
approach
to
addressing
lowdose
issues.
The
objective
of
the
June
2002
teleconference
meeting
(
docket
ID
number
OPPT
 
2002
 
0020)
was
for
the
EDMVS
to
provide
input
and
advice
on
the
steroidogenesis
detailed
review
paper.
The
objectives
of
the
July
2002
meeting
(
docket
ID
number
OPPT
2002
 
0029)
were:
1.
To
review
criteria,
recommended
by
EDSTAC
and
adopted
by
EDSP
for
screens.
2.
To
receive
an
update
on
the
NICEATM
estrogen
and
androgen
receptor
binding
efforts.
3.
To
discuss
and
provide
advice
on
general
dose
setting
issues,
and
to
provide
comments
and
advice
on:
 
A
pubertals
 
special
study
 
restricted
feeding.
 
A
mammalian
2­
generation
 
draft
PTU
special
study.
 
An
amphibian
metamorphosis
detailed
review
paper.
 
An
invertebrate
detailed
review
paper.
III.
Meeting
Objectives
for
the
December
2002
Teleconference
Meeting
The
objective
of
the
December
2002
teleconference
meeting
(
docket
ID
number
OPPT
 
2002
 
0059)
is
for
the
EDMVS
to
provide
input
and
advice
on
the
Tier
II
fish
lifecycle
assay
detailed
review
paper.
A
list
of
the
EDMVS
members
and
meeting
materials
are
available
on
our
Web
site
(
http://
www.
epa.
gov/
scipoly/
oscpendo/
edmvs.
htm),
and
in
the
EPA
Docket.

List
of
Subjects
Environmental
protection,
Endocrine
disruptors.

Dated:
November
4,
2002.
Joseph
Merenda,
Director,
Office
of
Science
Coordination
and
Policy,
Office
of
Prevention,
Pesticides
and
Toxic
Substances.
[
FR
Doc.
02
 
28910
Filed
11
 
13
 
02;
8:
45
am]

BILLING
CODE
6560
 
50
 
S
ENVIRONMENTAL
PROTECTION
AGENCY
[
OPP
 
2002
 
0294;
FRL
 
7279
 
3]

Alpha­
cyclodextrin,
Beta­
cyclodextrin,
and
Gamma­
cyclodextrin;
Notice
of
Filing
a
Pesticide
Petition
to
Establish
an
Exemption
from
the
Requirement
of
a
Tolerance
AGENCY:
Environmental
Protection
Agency
(
EPA).
ACTION:
Notice.

SUMMARY:
This
notice
announces
the
initial
filing
of
a
pesticide
petition
proposing
the
establishment
of
regulations
for
residues
of
alphacyclodextrin
beta­
cyclodextrin,
and
gamma­
cyclodextrin
in
or
on
various
food
commodities.
DATES:
Comments,
identified
by
docket
ID
number
OPP
 
2002
 
0294,
must
be
received
on
or
before
December
16,
2002.

ADDRESSES:
Comments
may
be
submitted
electronically,
by
mail,
or
through
hand
delivery/
courier.
Follow
the
detailed
instructions
as
provided
in
Unit
I.
of
the
SUPPLEMENTARY
INFORMATION.

FOR
FURTHER
INFORMATION
CONTACT:
Treva
Alston,
Minor
Use,
Inerts,
and
Emergency
Reponse
Branch,
Registration
Division
(
7505W),
Office
of
Pesticide
Programs,
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460
 
0001;
telephone
number:
(
703)
308
 
8373;
e­
mail
address:
alston.
treva@
epa.
gov.

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69004
Federal
Register
/
Vol.
67,
No.
220
/
Thursday,
November
14,
2002
/
Notices
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)
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
ID
number
OPP
 
2002
 
0294.
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/.
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.
Certain
types
of
information
will
not
be
placed
in
the
EPA
dockets.
Information
claimed
as
CBI
and
other
information
whose
disclosure
is
restricted
by
statute,
which
is
not
included
in
the
official
public
docket,
will
not
be
available
for
public
viewing
in
EPA's
electronic
public
docket.
EPA's
policy
is
that
copyrighted
material
will
not
be
placed
in
EPA's
electronic
public
docket
but
will
be
available
only
in
printed,
paper
form
in
the
official
public
docket.
To
the
extent
feasible,
publicly
available
docket
materials
will
be
made
available
in
EPA's
electronic
public
docket.
When
a
document
is
selected
from
the
index
list
in
EPA
dockets,
the
system
will
identify
whether
the
document
is
available
for
viewing
in
EPA's
electronic
public
docket.
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.
EPA
intends
to
work
towards
providing
electronic
access
to
all
of
the
publicly
available
docket
materials
through
EPA's
electronic
public
docket.
For
public
commenters,
it
is
important
to
note
that
EPA's
policy
is
that
public
comments,
whether
submitted
electronically
or
in
paper,
will
be
made
available
for
public
viewing
in
EPA's
electronic
public
docket
as
EPA
receives
them
and
without
change,
unless
the
comment
contains
copyrighted
material,
CBI,
or
other
information
whose
disclosure
is
restricted
by
statute.
When
EPA
identifies
a
comment
containing
copyrighted
material,
EPA
will
provide
a
reference
to
that
material
in
the
version
of
the
comment
that
is
placed
in
EPA's
electronic
public
docket.
The
entire
printed
comment,
including
the
copyrighted
material,
will
be
available
in
the
public
docket.
Public
comments
submitted
on
computer
disks
that
are
mailed
or
delivered
to
the
docket
will
be
transferred
to
EPA's
electronic
public
docket.
Public
comments
that
are
mailed
or
delivered
to
the
docket
will
be
scanned
and
placed
in
EPA's
electronic
public
docket.
Where
practical,
physical
objects
will
be
photographed,
and
the
photograph
will
be
placed
in
EPA's
electronic
public
docket
along
with
a
brief
description
written
by
the
docket
staff.

C.
How
and
To
Whom
Do
I
Submit
Comments?
You
may
submit
comments
electronically,
by
mail,
or
through
hand
delivery/
courier.
To
ensure
proper
receipt
by
EPA,
identify
the
appropriate
docket
ID
number
in
the
subject
line
on
the
first
page
of
your
comment.
Please
ensure
that
your
comments
are
submitted
within
the
specified
comment
period.
Comments
received
after
the
close
of
the
comment
period
will
be
marked
``
late.''
EPA
is
not
required
to
consider
these
late
comments.
If
you
wish
to
submit
CBI
or
information
that
is
otherwise
protected
by
statute,
please
follow
the
instructions
in
Unit
I.
D.
Do
not
use
EPA
dockets
or
e­
mail
to
submit
CBI
or
information
protected
by
statute.
1.
Electronically.
If
you
submit
an
electronic
comment
as
prescribed
in
this
unit,
EPA
recommends
that
you
include
your
name,
mailing
address,
and
an
email
address
or
other
contact
information
in
the
body
of
your
comment.
Also
include
this
contact
information
on
the
outside
of
any
disk
or
CD
ROM
you
submit,
and
in
any
cover
letter
accompanying
the
disk
or
CD
ROM.
This
ensures
that
you
can
be
identified
as
the
submitter
of
the
comment
and
allows
EPA
to
contact
you
in
case
EPA
cannot
read
your
comment
due
to
technical
difficulties
or
needs
further
information
on
the
substance
of
your
comment.
EPA's
policy
is
that
EPA
will
not
edit
your
comment,
and
any
identifying
or
contact
information
provided
in
the
body
of
a
comment
will
be
included
as
part
of
the
comment
that
is
placed
in
the
official
public
docket,
and
made
available
in
EPA's
electronic
public
docket.
If
EPA
cannot
read
your
comment
due
to
technical
difficulties
and
cannot
contact
you
for
clarification,
EPA
may
not
be
able
to
consider
your
comment.
i.
EPA
Dockets.
Your
use
of
EPA's
electronic
public
docket
to
submit
comments
to
EPA
electronically
is
EPA's
preferred
method
for
receiving
comments.
Go
directly
to
EPA
dockets
at
http://
www.
epa.
gov/
edocket,
and
follow
the
online
instructions
for
submitting
comments.
Once
in
the
system,
select
``
search,''
and
then
key
in
docket
ID
number
OPP
 
2002
 
0294.
The
system
is
an
``
anonymous
access''
system,
which
means
EPA
will
not
know
your
identity,
e­
mail
address,
or
other
contact
information
unless
you
provide
it
in
the
body
of
your
comment.

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/
Vol.
67,
No.
220
/
Thursday,
November
14,
2002
/
Notices
ii.
E­
mail.
Comments
may
be
sent
by
e­
mail
to
opp­
docket@
epa.
gov,
Attention:
Docket
ID
number
OPP
 
2002
 
0294.
In
contrast
to
EPA's
electronic
public
docket,
EPA's
e­
mail
system
is
not
an
``
anonymous
access''
system.
If
you
send
an
e­
mail
comment
directly
to
the
docket
without
going
through
EPA's
electronic
public
docket,
EPA's
e­
mail
system
automatically
captures
your
e­
mail
address.
E­
mail
addresses
that
are
automatically
captured
by
EPA's
e­
mail
system
are
included
as
part
of
the
comment
that
is
placed
in
the
official
public
docket,
and
made
available
in
EPA's
electronic
public
docket.
iii.
Disk
or
CD
ROM.
You
may
submit
comments
on
a
disk
or
CD
ROM
that
you
mail
to
the
mailing
address
identified
in
Unit
I.
C.
2.
These
electronic
submissions
will
be
accepted
in
WordPerfect
or
ASCII
file
format.
Avoid
the
use
of
special
characters
and
any
form
of
encryption.
2.
By
mail.
Send
your
comments
to:
Public
Information
and
Records
Integrity
Branch
(
PIRIB)
(
7502C),
Office
of
Pesticide
Programs
(
OPP),
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460
 
0001,
Attention:
Docket
ID
number
OPP
 
2002
 
0294.
3.
By
hand
delivery
or
courier.
Deliver
your
comments
to:
Public
Information
and
Records
Integrity
Branch
(
PIRIB),
Office
of
Pesticide
Programs
(
OPP),
Environmental
Protection
Agency,
Rm.
119,
Crystal
Mall
#
2,
1921
Jefferson
Davis
Hwy.,
Arlington,
VA,
Attention:
Docket
ID
number
OPP
 
2002
 
0294.
Such
deliveries
are
only
accepted
during
the
docket's
normal
hours
of
operation
as
identified
in
Unit
I.
B.
1.

D.
How
Should
I
Submit
CBI
To
the
Agency?
Do
not
submit
information
that
you
consider
to
be
CBI
electronically
through
EPA's
electronic
public
docket
or
by
e­
mail.
You
may
claim
information
that
you
submit
to
EPA
as
CBI
by
marking
any
part
or
all
of
that
information
as
CBI
(
if
you
submit
CBI
on
disk
or
CD
ROM,
mark
the
outside
of
the
disk
or
CD
ROM
as
CBI,
and
then
identify
electronically
within
the
disk
or
CD
ROM
the
specific
information
that
is
CBI).
Information
so
marked
will
not
be
disclosed
except
in
accordance
with
procedures
set
forth
in
40
CFR
part
2.
In
addition
to
one
complete
version
of
the
comment
that
includes
any
information
claimed
as
CBI,
a
copy
of
the
comment
that
does
not
contain
the
information
claimed
as
CBI
must
be
submitted
for
inclusion
in
the
public
docket
and
EPA's
electronic
public
docket.
If
you
submit
the
copy
that
does
not
contain
CBI
on
disk
or
CD
ROM,
mark
the
outside
of
the
disk
or
CD
ROM
clearly
that
it
does
not
contain
CBI.
Information
not
marked
as
CBI
will
be
included
in
the
public
docket
and
EPA's
electronic
public
docket
without
prior
notice.
If
you
have
any
questions
about
CBI
or
the
procedures
for
claiming
CBI,
please
consult
the
person
listed
under
FOR
FURTHER
INFORMATION
CONTACT.

E.
What
Should
I
Consider
as
I
Prepare
My
Comments
for
EPA?

You
may
find
the
following
suggestions
helpful
for
preparing
your
comments:
1.
Explain
your
views
as
clearly
as
possible.
2.
Describe
any
assumptions
that
you
used.
3.
Provide
copies
of
any
technical
information
and/
or
data
you
used
that
support
your
views.
4.
If
you
estimate
potential
burden
or
costs,
explain
how
you
arrived
at
the
estimate
that
you
provide.
5.
Provide
specific
examples
to
illustrate
your
concerns.
6.
Make
sure
to
submit
your
comments
by
the
deadline
in
this
notice.
7.
To
ensure
proper
receipt
by
EPA,
be
sure
to
identify
the
docket
ID
number
assigned
to
this
action
in
the
subject
line
on
the
first
page
of
your
response.
You
may
also
provide
the
name,
date,
and
Federal
Register
citation.

II.
What
Action
is
the
Agency
Taking?

EPA
has
received
a
pesticide
petition
as
follows
proposing
the
establishment
and/
or
amendment
of
regulations
for
residues
of
a
certain
pesticide
chemical
in
or
on
various
food
commodities
under
section
408
of
the
Federal
Food,
Drug,
and
Cosmetic
Act
(
FFDCA),
21
U.
S.
C.
346a.
EPA
has
determined
that
this
petition
contains
data
or
information
regarding
the
elements
set
forth
in
FFDCA
section
408(
d)(
2);
however,
EPA
has
not
fully
evaluated
the
sufficiency
of
the
submitted
data
at
this
time
or
whether
the
data
support
granting
of
the
petition.
Additional
data
may
be
needed
before
EPA
rules
on
the
petition.

List
of
Subjects
Environmental
protection,
Agricultural
commodities,
Feed
additives,
Food
additives,
Pesticides
and
pests,
Reporting
and
recordkeeping
requirements.
Dated:
November
4,
2002.
Debra
Edwards,
Director,
Registration
Division,
Office
of
Pesticide
Programs.

Summary
of
Petition
The
petitioner
summary
of
the
pesticide
petition
is
printed
below
as
required
by
FFDCA
section
408(
d)(
3).
The
summary
of
the
petition
was
prepared
by
the
Wacker
Biochem
Corporation
and
represents
the
view
of
the
petitioner.
The
petition
summary
announces
the
availability
of
a
description
of
the
analytical
methods
available
to
EPA
for
the
detection
and
measurement
of
the
pesticide
chemical
residues
or
an
explanation
of
why
no
such
method
is
needed.

PP
2E6514
Summary
of
Petitions
EPA
has
received
a
pesticide
petition
(
2E6514)
from
Wacker
Biochem
Corporation,
3301
Sutton
Road,
Adrian,
MI
49221
 
9397
proposing,
pursuant
to
section
408(
d)
of
the
FFDCA,
21
U.
S.
C.
346a(
d),
to
amend
40
CFR
180.950
to
establish
an
exemption
from
the
requirement
of
a
tolerance
for
alphacyclodextrin
(
CAS
No.
10016
 
20
 
3),
beta­
cyclodextrin
(
CAS
No.
7585
 
39
 
9),
and
gamma­
cyclodextrin
(
CAS
No.
17465
 
86
 
0)
in
or
on
raw
agricultural
commodities
resulting
from
the
use
of
alpha­,
beta­,
and
gamma­
cyclodextrin
as
ingredients
in
pesticide
formulations
used
in
accordance
with
good
agricultural
practices.
Alphacyclodextrin
beta­
cyclodextrin,
and
gamma­
cyclodextrin
are
naturally
occurring
compounds
derived
from
the
degradation
of
starch
by
the
glucosyltransferase
enzyme
(
CGTase).
Dglucose
molecules
that
are
formed
by
the
digestion
of
starch
are
joined
``
headto
tail''
to
form
alpha­,
beta­,
and
gamma­
cyclodextrin
which
are
ringshaped
molecules.
Alpha­,
beta­,
and
gamma­
cyclodextrin
are
comprised
of
six,
seven
and
eight
D­
glucose
units,
respectively.
EPA
has
determined
that
the
petition
contains
data
or
information
regarding
the
elements
set
forth
in
section
408(
d)(
2)
of
the
FFDCA;
however,
EPA
has
not
fully
evaluated
the
sufficiency
of
the
submitted
data
at
this
time
or
whether
the
data
support
granting
of
the
petition.
Additional
data
may
be
needed
before
EPA
rules
on
the
petition.

A.
Residue
Chemistry
1.
Plant
metabolism.
While
no
studies
have
been
conducted
to
evaluate
the
metabolism
of
alpha­,
beta­,
and
gammacyclodextrin
in
plants,
the
metabolic
products
in
plants
are
anticipated
to
be
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ubiquitous,
naturally
occurring
simple
sugars
and
CO2.
The
anticipated
plant
metabolites
are
not
of
toxicological
concern.
2.
Analytical
method.
An
analytical
method
is
not
required
for
enforcement
purposes
since
Wacker
Biochem
is
requesting
the
establishiment
of
an
exemption
from
the
requirement
of
a
tolerance
without
any
numerical
limitation.

B.
Toxicological
Profile
Alpha­
cyclodextrin:
The
Food
&
Agriculture
Organization/
World
Health
Organization
(
FAO/
WHO)
Joint
Expert
Committee
on
Food
Additives
(
JECFA)
has
evaluated
alpha­
cyclodextrin
and
in
2001
allocated
an
acceptable
daily
intake
(
ADI)
of
``
not
specified.''
This
is
the
most
desirable
ADI
allocation
issued
by
JECFA.
Beta­
cyclodextrin:
A
GRAS
(
generally
recognized
as
safe)
petition
was
submitted
by
Roquette
America
Inc/
American
Maize­
Products
Co.
for
use
as
a
formulation
aid
in
the
production
of
dry
flavoring
mixes
(
February
3,
1992)
and
for
use
as
a
flavor
protectant
(
September
20,
1996).
A
self­
affirmation
of
beta­
cyclodextrin
as
a
flavor
carrier
in
foods
was
completed
by
Cerestar
USA
on
February
4,
1998.
Wacker
Biochem
Corporation
has
submitted
to
the
FDA
an
independent
GRAS
determination
for
beta­
cyclodextrin
for
use
as
a
flavor
carrier
or
protectant
in
baked
goods
prepared
from
dry
mixes,
breakfast
cereal,
chewing
gum,
compressed,
candies,
gelatins
and
puddings,
flavored
coffee
and
tea,
processed
cheese
products,
dry
mix
for
beverages,
flavored
savory
snacks
and
crackers,
dry
mixes
for
soups
(
GRAS
Notice
No.
74).
FDA
has
not
yet
completed
its
review
of
the
self­
affirmation.
Gamma­
cyclodextrin:
Wacker
Biochem
Corporation
has
determined
that
gamma­
cyclodextrin
is
generally
recognized
as
safe
(
GRAS)
when
used
as
a
stabilizer,
emulsifier,
carrier
and
formulation
aid
in
foods.
The
toxicology
and
metabolism
data
relevant
to
the
proposed
tolerance
exemption
are
summarized
in
Table
1.

TABLE
1.
 
TOXICITY
AND
METABOLISM
Study
Cyclo­
dextrin
Result
Acute
oral
toxicity
Alpha­
LD50
>
10,000
mg/
kg
(
rat)

Beta­
LD50
>
12,000
mg/
kg
(
rabbit)

Gamma­
LD50
>
8,000
mg/
kg
(
rat)

Acute
dermal
toxicity
No
data
are
available
Acute
inhalation
toxicity
No
data
are
available
Primary
eye
irritation
Alpha­
Crystalline
form:
Eye
irritant,
but
not
corrosive
50%
suspension:
Non­
irritant
Beta­
Slight
irritant
Gamma­
Non­
irritant
Primary
dermal
irritation
Alpha­
Non­
irritant
Beta­
Non­
irritant
Dermal
sensitization
Alpha­
Non­
sensitizer
Beta­
Non­
sensitizer
Gamma­
Non­
sensitizer
28
 
Day
feeding
study:
rodent
Alpha­
NOEL
=
5%
in
the
diet
Beta­
NOEL
=
5%
in
the
diet
90
 
Day
feeding
study:
rat
Alpha­
NOAEL
=
20%
in
diet
highest
dose
tested
(
HDT)

Beta­
NOAEL
=
400
mg/
kg/
day
by
gavage
Gamma­
NOAEL
=
20%
in
diet
HDT
90
 
Day
feeding
study:
dog
Alpha­
NOAEL
=
20%
in
diet
HDT
Beta­
NOEL
=
2.5%
in
diet
LOEL
=
5%
in
diet.
Hematology
and
clinical
chemistryeffects
observed
indicated
slight
toxicity
Gamma­
NOAEL
=
20%
in
diet
HDT
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TABLE
1.
 
TOXICITY
AND
METABOLISM
 
Continued
Study
Cyclo­
dextrin
Result
Subchronic
dermal
toxicity
No
data
are
available
Chronic
feeding
and
oncogenicity
Beta­
1
 
year
dog
NOAEL
=
1%
in
diet
=
350
mg/
kg/
day
LOAEL
=
2.5%
in
diet
=
925
mg/
kg/
day
Increased
levels
of
protein
were
observed
in
urine
2­
year
rat:
NOEL
for
oncogenicity
=
6%
in
diet
Small
percentage
is
absorbed
by
the
intestinal
walls
and
causes
kidney
damage
Beta­
cyclodextrin
is
not
degraded
in
the
small
intestine.
In
the
large
intestine
it
undergoes
bacterial
degradation,
leading
to
gas
generation
and
diarrhea
Teratology
study:
rodent
Alpha­
Not
teratogenic,
embryotoxic
or
fetotoxic
at
doses
up
to
20%
of
diets
in
both
rats
and
rabbits
HDT
Beta­
Not
teratogenic,
embryotoxic
or
fetotoxic
at
5,000
mg/
kg/
day
in
rats
HDT
and
at
1,000
mg/
kg/
day
in
rabbits
HDT
Gamma­
Not
teratogenic,
embryotoxic
or
fetotoxic
at
doses
up
to
20%
of
diets
in
both
rats
and
rabbits
HDT
2­
Generation
reproduction
Beta­
NOAEL
in
rats
=
1%
in
diet
=
700
mg/
kg/
day
LOAEL
in
dams
and
offspring
=
2.5%
in
the
diet
Gene
mutation
test
Alpha­
Negative
Ames
test
Gamma­
Negative
Ames
test
Structural
chromosomal
aberration
test
Beta­
Negative
in
rats
at
dose
of
2%
in
diet
Other
genotoxic
effects
Alpha­
Negative
micronucleus
test
Gamma­
Negative
micronucleus
test
Metabolism
(
oral
dosing
Alpha
Absorption:
2%
dose
absorbed
Distribution:
Liver
(>
0.05%
dose)
and
kidney
(>
0.01%
dose)
Metabolism:
Extensively
and
predominantly
metabolized
to
C02
by
intestinal
flora
Excretion:
60%
dose
expelled
as
CO2
26
 
33%
dose
incorporated
7
 
14%
dose
excreted
in
urine
and
feces
Beta­
Absorption:
No
significant
absorption
as
intact
molecule.
Absorption
as
sugars
is
similar
to
that
of
glucose;
occurs
via
passive
transport
Distribution:
Max.
0.9%
in
GI
tract
60
hours
after
dosing
Metabolism:
Hydrolysis
to
open
chain
dextrins
and
glucose
occurs
in
the
large
intestine
by
intestinal
flora
Excretion:
66.8%
dose
as
CO2
in
expired
air
within
23
hours
of
dosing.
0.6%
to
4%
in
feces
within
60
hours
of
dosing
Gamma­
Absorption:
>
0.1%
as
intact
molecule
Metabolism:
Rapid
and
total
degradation
to
glucose
in
the
upper
intestinal
tract
by
intestinal
flora
Excretion:
60%
dose
expelled
as
CO2
37%
dose
incorporated
3%
dose
excreted
in
urine
and
feces
1.
Metabolite
toxicology.
Alpha­,
beta­,
and
gamma­
cyclodextrin
are
metabolized
to
simple
sugars
and
CO2.
These
metabolites
are
also
metabolites
of
the
digestion
of
carbohydrates
in
the
diet
and
have
no
significant
toxicity.
2.
Endocrine
disruption.
Based
upon
the
available
data,
alpha­,
beta­,
and
gamma­
cyclodextrin
are
not
anticipated
to
disrupt
the
endocrine
system.

C.
Aggregate
Exposure
1.
Food.
Alpha­
cyclodextrin,
betacyclodextrin
and
beta­
cyclodextrin
are
naturally
occurring
compounds
and
are
used
as
food
additives.
Alpha­
cyclodextrin
food
additive
uses
include:
Carrier;
encapsulating
agent
for
food
additives,
flavorings
and
vitamins;
stabilizer;
and
absorbent.
The
ADI
is
``
not
specified.''

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Beta­
cyclodextrin
is
used
as
a
flavor
carrier
or
protectant.
See
Table
2
for
a
detailed
list
of
uses
and
the
maximum
concentrations.

TABLE
2.
 
MAXIMUM
CONCENTRATION
OF
BETA­
CYCLODEXTRIN
IN
FOODS
Beta­
Cyclodextrin
Use
Maximum
Concentration
Baked
goods
prepared
from
dry
mixes
breakfast
cereal
chewing
gum
compressed
candies
2%

Gelatins
and
puddings
flavored
coffee
and
tea
processed
cheese
products
dry
mix
for
beverages
1%

Flavored
savory
snacks
and
crackers
0.5%

Dry
mixes
for
soups
0.2%

Gamma­
cyclodextrin
is
used
in
foods
such
as
bread
spreads,
frozen
dairy
desserts,
ready
to
eat
dairy
desserts,
desserts
prepared
from
dry
mixes,
fruit
fillings,
cheese
and
cream
fillings,
chewing
gum,
dietary
supplements.
See
Table
3
for
a
complete
list
of
uses
and
the
maximum
concentrations.

TABLE
3.
 
MAXIMUM
CONCENTRATION
OF
GAMMA­
CYCLODEXTRIN
IN
FOODS
Gamma­
Cyclodextrin
Use
Maximum
Use
Concentration
Carrier
for
flavors,
sweeteners
and
colors
<
1%

Dry
mixes
for
beverages
<
1%

Dry
mixes
for
soups
<
1%

Dry
mixes
for
dressings,
gravies,
and
sauces
<
1%

Dry
mixes
for
puddings,
gelatins,
and
fillings
<
1%

Instant
coffee
and
instant
tea
<
1%

Coffee
whiteners
<
1%

Compressed
candies
<
1%

Chewing
gum
<
1%

Breakfast
cereals
(
ready­
to­
eat)
<
1%

Savory
snacks
and
crackers
<
1%

Spices
and
seasonings
<
1%

Carrier
for
vitamins
<
1%

For
use
in
dry
food
mixes
and
dietary
supplements
<
90%
1
Carrier
for
polyunsaturated
fatty
acids
For
use
in
dry
food
mixes
and
dietary
supplements
<
80%
1
Flavor
modifier
Soya
milk
<
2%

Stabilizer
Bread
spreads
(
fat­
reduced)
<
20%

Frozen
dairy
desserts
<
3%

Baked
goods
(
excl.
bread,
but
incl.
dough
and
baking
mixes)
<
2%

Bread
<
1%

Fruit­
based
fillings
<
3%

Fat­
based
fillings
<
5%

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69009
Federal
Register
/
Vol.
67,
No.
220
/
Thursday,
November
14,
2002
/
Notices
TABLE
3.
 
MAXIMUM
CONCENTRATION
OF
GAMMA­
CYCLODEXTRIN
IN
FOODS
 
Continued
Gamma­
Cyclodextrin
Use
Maximum
Use
Concentration
Processed
cheese
<
3%

Dairy
deserts
(
ready­
to­
eat
and
prepared
from
dry
mixes)
<
3%

1Percent
by
weight
of
gamma­
cyclodextrin
relative
to
the
nutrient
for
which
gamma­
cyclodextrin
is
used
as
a
carrier.

The
proposed
use
of
alpha­,
beta­,
and
gamma­
cyclodextrin
as
ingredients
in
pesticide
formulations
is
anticipated
to
result
in
no
significant
additional
dietary
exposure
to
alpha­,
beta­,
and
gamma­
cyclodextrin.
2.
Drinking
water.
Any
alpha­,
beta­,
and
gamma­
cyclodextrin
in
drinking
water
sources
is
anticipated
to
degrade
to
simple
sugars
and
CO2
that
will
be
used
by
plants
as
building
blocks
for
the
plant's
growth.
No
significant
exposure
of
alpha­,
beta­,
and
gammacyclodextrin
via
drinking
water
is
anticipated.
3.
Non­
dietary
exposure.
Cyclodextrins
are
used
extensively
in
the
cosmetic
industry.
Alpha­,
beta­,
and
gamma­
cyclodextrin
are
too
large
to
be
absorbed
through
the
skin,
so
no
significant
systemic
exposure
is
anticipated
to
result
from
the
cosmetic
use
or
other
residential
uses
of
alpha­,
beta­,
and
gamma­
cyclodextrin.

D.
Cumulative
Effects
Alpha­,
beta­,
and
gammacyclodextrin
have
no
significant
toxic
effects
for
consideration
of
cumulative
effects.

E.
Safety
Determination
1.
U.
S.
population.
Alpha­,
beta­,
and
gamma­
cyclodextrin
are
low
toxicity,
naturally
occurring
compounds
that
are
use
as
food
additives.
The
D­
glucose
building
blocks
of
alpha­,
beta­,
and
gamma­
cyclodextrin
are
also
the
result
of
digestion
of
starchy
foods
such
as
bread,
rice,
potatoes
and
pasta.
Alpha­
,
beta­,
and
gamma­
cyclodextrin
are
part
of
the
current
U.
S.
diet,
and
the
proposed
new
uses
of
alpha­,
beta­,
and
gamma­
cyclodextrin
as
ingredients
in
pesticide
formulations
is
not
anticipated
to
contribute
significantly
to
the
amount
of
alpha­,
beta­,
and
gammacyclodextrin
in
the
U.
S.
diet.
The
proposed
new
use
of
alpha­,
beta­,
and
gamma­
cyclodextrin
for
use
as
an
inert
ingredient
in
pesticide
formulations
has
a
reasonable
certainty
of
no
harm
to
the
U.
S.
population.
2.
Infants
and
children.
Alpha­,
beta­
,
and
gamma­
cyclodextrin
have
no
significant
toxic
effects
that
are
specific
to
infants
or
children.
The
proposed
new
uses
of
alpha­,
beta­,
and
gammacyclodextrin
as
ingredients
in
pesticide
formulations
has
a
reasonable
certainty
of
no
harm
to
infants
or
children.

F.
International
Tolerances
Alpha­
cyclodextrin:
The
FAO/
WHO
JECFA
has
evaluated
alpha­
cyclodextrin
and
in
2001
allocated
an
ADI
of
``
not
specified.''
This
is
the
most
desirable
ADI
and
is
limited
to
low
toxicity
compounds.
Beta­
cyclodextrin:
A
request
was
submitted
to
the
CODEX
Alimentarius
Commission
for
additive
clearance
in
the
General
Standard
on
Food
Additives
(
INS
No.
459)
at
a
maximum
level
of
50,000
milligrams/
kilogram
(
mg/
kg)
in
food
category
5.3,
for
chewing
gum.
A
new
monograph
for
beta­
cyclodextrin
has
been
published
in
the
First
Supplement
to
the
Fourth
Edition
of
the
Food
Chemicals
Codex.
Betacyclodextrin
is
published
in
Annex
V
of
the
Official
Journal
of
the
European
Communities­
Food
Additives
as
a
carrier
only
for
food
additives
up
to
1
gram/
kilogram
food.
An
ADI
of
5
mg/
kg
body
weight
was
established
at
the
February
1995
joint
FAO/
WHO
meeting
of
the
expert
committee
on
food
additives
and
is
published
in
WHO
Food
Additive
Series
35.
Gamma­
cyclodextrin:
The
FAO/
WHO
JECFA
has
evaluated
alpha­
cyclodextrin
and
in
2,000
(
53rd
meeting)
allocated
an
ADI
of
``
not
specified.''
This
is
the
most
desirable
ADI
and
is
limited
to
low
toxicity
compounds.
[
FR
Doc.
02
 
28909
Filed
11
 
13
 
02;
8:
45
am]

BILLING
CODE
6560
 
50
 
S
FEDERAL
COMMUNICATIONS
COMMISION
Notice
of
Public
Information
Collection(
s)
Being
Reviewed
by
the
Federal
Communications
Commission
November
7,
2002.
SUMMARY:
The
Federal
Communications
Commission,
as
part
of
its
continuing
effort
to
reduce
paperwork
burden
invites
the
general
public
and
other
Federal
agencies
to
take
this
opportunity
to
comment
on
the
following
information
collection(
s),
as
required
by
the
Paperwork
Reduction
Act
of
1995,
Pub.
L.
104
 
13.
An
agency
may
not
conduct
or
sponsor
a
collection
of
information
unless
it
displays
a
current
valid
control
number.
No
person
shall
be
subject
to
any
penalty
for
failing
to
comply
with
a
collection
of
information
subject
to
the
Paperwork
Reduction
Act
(
PRA)
that
does
not
display
a
valid
control
number.
Comments
are
requested
concerning
(
a)
Whether
the
proposed
collection
of
information
is
necessary
for
the
proper
performance
of
the
functions
of
the
Commission,
including
whether
the
information
shall
have
practical
utility;
(
b)
the
accuracy
of
the
Commission's
burden
estimate;
(
c)
ways
to
enhance
the
quality,
utility,
and
clarity
of
the
information
collected;
and
(
d)
ways
to
minimize
the
burden
of
the
collection
of
information
on
the
respondents,
including
the
use
of
automated
collection
techniques
or
other
forms
of
information
technology.
DATES:
Written
comments
should
be
submitted
on
or
before
January
13,
2003.
If
you
anticipate
that
you
will
be
submitting
comments,
but
find
it
difficult
to
do
so
within
the
period
of
time
allowed
by
this
notice,
you
should
advise
the
contact
listed
below
as
soon
as
possible.
ADDRESSES:
Direct
all
comments
to
Les
Smith,
Federal
Communications
Commission,
Room
1
 
A804,
445
12th
Street,
SW.,
Washington,
DC
20554,
or
via
the
Internet
to
lesmith@
fcc.
gov.
FOR
FURTHER
INFORMATION
CONTACT:
For
additional
information
or
copies
of
the
information
collection(
s)
contact
Les
Smith
at
202
 
418
 
0217
or
via
the
Internet
at
lesmith@
fcc.
gov.
SUPPLEMENTARY
INFORMATION:
OMB
Control
Number:
3060
 
0960.
Title:
Application
of
Network
Non­
Duplication,
Syndicated
Exclusivity,
and
Sports
Blackout
Rules
to
Satellite
Retransmissions
of
Broadcast
Signals.
Form
Number:
N/
A.
Type
of
Review:
Revision
of
a
currently
approved
collection.
Respondents:
Businesses
or
other
forprofit
entities.
Number
of
Respondents:
1,407.
Estimated
Time
per
Response:
0.5
to
1.0
hours.
Frequency
of
Response:
On
occasion
reporting
requirements;
Third
party
disclosure.
Total
Annual
Burden:
63,992
hours.

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