Document ID: EPA-HQ-OPP-2002-0275-0001
Agency: epa
Document Type: Notice
Title: Hydrogenated Starch Hydrolysate; Notice of Filing a Pesticide Petition to Establish an Exemption 
from the Requirement of a Tolerance for a Certain Pesticide Chemical in or on Food
Posted Date: 2002-10-23T04:00Z

65115
Federal
Register
/
Vol.
67,
No.
205
/
Wednesday,
October
23,
2002
/
Notices
Drinking
Water
(4607M),
1200
Pennsylvania
Avenue,
NW.,
Washington,
DC
20460
(e­
mail:
kapadia.
amit@
epa.
gov;
Tel:
202–
564–
4879).

SUPPLEMENTARY
INFORMATION:
As
part
of
the
2002
appropriations
process,
Congress
directed
EPA
to
``
begin
immediately
to
review
the
Agency's
affordability
criteria
and
how
small
system
variance
and
exemption
programs
should
be
implemented
for
arsenic''
(Conference
Report
107–
272,
page
175).
Congress
further
directed
the
Agency
to
prepare
a
report,
which
EPA
submitted
(Report
to
Congress:
Small
System
Arsenic
Implementation
Issues:
EPA
815–
R–
02–
003),
``
on
its
review
of
the
affordability
criteria
and
the
administrative
actions
undertaken
or
planned
to
be
undertaken
by
the
Agency,
as
well
as
potential
funding
mechanisms
for
small
community
compliance
and
other
legislative
actions,
which,
if
taken
by
the
Congress,
would
best
achieve
appropriate
extensions
of
time
for
small
communities
while
also
guaranteeing
maximum
compliance.
''
(Conference
Report
107–
272,
page
175).
In
evaluating
treatment
technologies
for
small
systems,
EPA
currently
uses
an
affordability
threshold
of
2.5%
of
median
household
income.
EPA's
national­
level
affordability
criteria
consist
of
two
major
components:
an
expenditure
baseline
and
an
affordability
threshold.
The
expenditure
baseline
(derived
from
annual
median
household
water
bills)
is
subtracted
from
the
affordability
threshold
(a
share
of
median
household
income
that
EPA
believes
to
be
a
reasonable
upper
limit
for
these
water
bills)
to
determine
the
expenditure
margin
(the
maximum
increase
in
household
water
bills
that
can
be
imposed
by
treatment
and
still
be
considered
affordable).
EPA
compares
the
cost
of
treatment
technologies
against
the
available
expenditure
margin
to
determine
if
an
affordable
compliance
technology
can
be
identified.
If
EPA
cannot
identify
an
affordable
compliance
technology,
then
it
attempts
to
identify
a
variance
technology.
Findings
must
be
made
at
both
the
Federal
and
State
level
that
compliance
technologies
are
not
affordable
for
small
systems
before
a
variance
can
be
granted.
EPA
is
asking
the
NDWAC
for
advice
on
its
national­
level
affordability
criteria
and
the
methodology
used
to
establish
these
criteria.
Taking
into
consideration
the
structure
of
the
Safe
Drinking
Water
Act
and
the
limitations
of
readily
available
data
and
information
sources,
EPA
is
seeking
the
Council's
opinion
of
the
national
level
affordability
criteria,
methodology
for
deriving
the
criteria,
and
approach
to
applying
those
criteria
to
NPDWRs.
As
part
of
the
Council's
review
of
EPA's
national­
level
affordability
criteria,
the
Agency
is
seeking
input
on
(1)
the
Agency's
overall
approach,
(2)
alternatives,
if
any,
to
the
use
of
median
household
income
as
a
metric,
(3)
alternatives,
if
any,
to
2.5%
as
a
metric,
(4)
alternatives,
if
any,
to
calculating
the
expenditure
baseline,
(5)
the
usefulness
of
a
separate
criteria
for
ground
and
surface
water
systems,
(6)
including
an
evaluation
of
the
potential
availability
of
financial
assistance,
and
(7)
the
need
for
making
affordability
determinations
on
a
regional
basis.
Other
issue
areas
may
also
be
discussed.
The
meeting
is
open
to
the
public;
statements
from
the
public
will
be
taken
at
the
close
of
the
meeting.
EPA
is
not
soliciting
written
comments
and
is
not
planning
to
formally
respond
to
comments.
This
will
be
the
third,
fourth,
and
fifth
work
group
meetings
on
this
topic.
At
the
first
meeting
held
on
September
11–
12
,
the
work
group
was
briefed
by
EPA
on
the
approach
to
affordability
taken
by
the
Agency.
At
the
first
meeting,
the
work
group
also
devised
an
approach
to
answer
the
Agency's
charge
questions.
For
the
second
work
group
meeting
(to
be
held
on
October
21–
22),
other
technical
experts
on
financial
assistance
have
been
invited
to
speak.
The
purpose
of
these
last
three
meetings
is
to
continue
the
workgroup
deliberations
and
to
draft
a
report
for
the
full
National
Drinking
Water
Advisory
Council.

Dated:
October
17,
2002.
Cynthia
C.
Dougherty,
Director,
Office
of
Ground
Water
and
Drinking
Water.
[FR
Doc.
02–
26994
Filed
10–
22–
02;
8:
45
am]

BILLING
CODE
6560–
50–
P
ENVIRONMENTAL
PROTECTION
AGENCY
[OPP–
2002–
0275;
FRL–
7276–
8]

Hydrogenated
Starch
Hydrolysate;
Notice
of
Filing
a
Pesticide
Petition
to
Establish
an
Exemption
From
the
Requirement
of
a
Tolerance
for
a
Certain
Pesticide
Chemical
in
or
on
Food
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
a
certain
pesticide
chemical
in
or
on
various
food
commodities.
DATES:
Comments,
identified
by
docket
ID
number
OPP–
2002–
0275
must
be
received
on
or
before
November
22,
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,
Registration
Division
(7505C),
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.

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
categories
and
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
the
table
could
also
be
affected.
The
North
American
Industrial
Classification
System
(NAICS)
codes
have
been
provided
to
assist
you
and
others
in
determining
whether
or
not
this
action
might
apply
to
certain
entities.
If
you
have
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–
0275.
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
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15:
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65116
Federal
Register
/
Vol.
67,
No.
205
/
Wednesday,
October
23,
2002
/
Notices
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–
0275.
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.
ii.
E­
mail.
Comments
may
be
sent
by
e­
mail
to
opp­
docket@
epa.
gov,
Attention:
Docket
ID
Number
OPP–
2002–
0275.
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–
0275.
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–
0275.
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
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Register
/
Vol.
67,
No.
205
/
Wednesday,
October
23,
2002
/
Notices
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:
October
9,
2002.
Debra
Edwards,
Acting
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
petitioner,
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.

Hydrogenated
Starch
Hydrolysate
PP
2E6503
EPA
has
received
a
pesticide
petition
(2E6503)
from
Grain
Processing
Corporation,
1600
Oregon
Street,
Muscatine,
Iowa
52761
proposing,
pursuant
to
section
408(
d)
of
the
FFDCA,
21
U.
S.
C.
346a(
d),
to
amend
40
CFR
part
180
to
establish
an
exemption
from
the
requirement
of
a
tolerance
for
hydrogenated
starch
hydrolysate
(HSH)
in
or
on
growing
crops
or
when
applied
to
the
raw
agricultural
commodity
after
harvest.
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.
Like
any
other
carbohydrate,
HSH
degrades
readily
in
the
soil
and
other
substrates
into
carbon
dioxide
and
water.
HSH
(CAS
number
68425–
17–
2)
is
a
carbohydrate
polymer
with
a
theoretical
molecular
weight
(in
amu)
of
1,000–
3,600.
It
can
be
supplied
as
a
liquid
syrup
or
white
powder.
The
empirical
formula
of
the
components
of
HSH
are:

Components
Formula
Sorbitol
C6H14O6
Maltitol
C12H24O11
Hydrogenated
polysaccharides
C12H24O11
plus
C6H10O5
for
each
additional
glucose
moiety
in
the
chain
HSH
is
highly
soluble
in
water.
The
aqueous
solution
has
a
pH
range
of
4.0–
6.0.
It
hydrolyzes
slowly
to
glucose
and
sorbitol.
It
combusts
at
300
0
C
to
carbon
dioxide
and
water.
2.
Analytical
method.
The
qualitative
analysis
of
HSH
in
the
products
to
which
it
has
been
added
may
be
accomplished
by
extraction
of
the
sorbitol
and
maltitol
moieties
with
appropriate
solvents,
followed
by
gas
chromatography
of
the
extracts.
Similarly,
the
quantity
of
HSH
occurring
in
food
may
be
estimated
by
determining
the
amount
of
maltitol
recovered
and
applying
an
appropriate
factor.
Information
on
the
sensitivity
and
reproducibility
of
the
method
has
also
been
developed.
3.
Magnitude
of
residues.
HSH
is
readily
degraded
by
microorganisms
on
leaf
surfaces
and
in
the
soil.
Due
to
the
solubility
of
this
carbohydrate,
rain,
or
other
water
sources
wash
the
carbohydrate
into
the
soil
where
it
is
degraded
by
microorganisms
into
carbon
dioxide
and
water.
No
harmful
residues
are
produced.
B.
Toxicological
Profile
HSH
has
been
widely
used
in
foods
since
the
early
1980s.
It
has
been
marketed
extensively
by
Roquette,
Lonza
and
SPI
Polyols
for
years.
Grain
Processing
Corporation
produces
HSH
using
a
process
that
is
equivalent
to
the
process
petitioned
to
the
Food
and
Drug
Administration
by
Lonza
and
Roquette
Freres
for
GRAS
(generally
recognized
as
safe)
affirmation.
In
support
of
the
safety
of
our
HSH,
Grain
Processing
Corporation
and
SPI
Polyols
cites
data
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Federal
Register
/
Vol.
67,
No.
205
/
Wednesday,
October
23,
2002
/
Notices
submitted
by
Roquette
in
its
Lycasin
80/
55
petition
regarding
numerous
studies
relating
to
the
safety
of
the
ingredient,
including
reports
on:
Digestion,
absorption,
distribution
and
excretion;
acute
oral
toxicity,
subchronic
toxicity,
genotoxicity,
reproduction,
biological
tolerance,
human
exposure,
and
laxation
effects.
1.
Acute
toxicity.
The
acute
oral
toxicity
of
HSH
has
been
evaluated.
The
acute
oral
lethal
dose
(LD50)
of
HSH
is
greater
than
10
grams/
kilogram
(g/
kg).
2.
Genotoxicty.
As
stated
in
Roquette's
GRAS
submission
of
Lycasin
80/
55,
HSH
is
nonmutagenic
and
nonclastogenic
in
short­
term
in
vivo,
and
in
vitro
studies.
3.
Reproductive
and
developmental
toxicity.
Again
as
noted
in
Roquette's
GRAS
submission
of
Lycasin
80/
55
HSH
products,
when
administered
to
rats
over
3­
generations,
produce
no
significant
effects
on
reproduction.
4.
Subchronic
toxicity.
In
Roquette's
GRAS
submission
for
Lycasin
80/
55,
it
is
noted
that
when
administered
orally
to
rats
and
dogs
in
amounts
of
5
g/
kg
to
15
g/
kg
of
body
weight
per
day
for
90
days,
HSH
produced
no
toxicologically
meaningful
effects
which
could
not
be
accounted
for
by
the
presence
of
sorbitol.
The
possible
treatment
related
effects
are
aggregates
in
the
renal
pelvis
of
some
rats,
diarrhea
in
most
dogs,
and
minimal
ectasia
in
the
renule
tubules
of
some
dogs.
5.
Chronic
toxicity.
HSH
is
used
extensively
in
foods.
Grain
Processing
Corporation
is
not
aware
of
any
chronic
toxic
effects
associated
with
this
product.
6.
Animal
metabolism.
The
GRAS
submission
for
Lycasin
80/
55
developed
by
Roquette
Freres
states
that
over
96%
of
HSH
(Lycasin
80/
55)
is
broken
down
by
the
mammalian
digestive
system
into
the
GRAS
substances,
glucose
and
sorbitol,
the
remaining
4%
is
in
the
form
of
maltitol.
One
half
of
the
maltitol
is
excreted
in
the
feces
and
the
majority
of
the
remainder
is
excreted
in
the
urine.
Within
the
first
2
hours
after
oral
administration
of
HSH
(Lycasin
80/
55),
virtually
all
of
the
glucose
to
glucose
bonds
are
broken
down
in
the
digestive
system,
producing
a
resulting
mixture
of
glucose,
sorbitol,
and
maltitol.
Within
7
hours,
95%
of
the
total
maltitol,
is
broken
down
into
glucose
and
sorbitol.
Of
the
remaining
5%
of
maltitol,
2%
is
found
in
the
digestive
tube
and
fecal
contents,
less
than
1%
is
found
in
the
plasma,
and
approximately
1%
is
excreted
in
the
urine.
There
is
no
accumulation
of
maltitol
in
the
plasma,
liver,
kidneys,
or
spleen
of
rats
fed
13.5
g/
kg/
day
of
Lycasin
80/
55
for
10
days
irrespective
of
whether
measurements
are
made
12
hours
or
10
days
after
cessation
of
dosing.
Lycasin
80/
55
at
the
dose
levels
tested,
30
to
180
grams
per
day,
produces
no
significant
variations
in
the
clinical
chemical,
hematological
or
urinary
profile
of
humans
with
the
exception
of
glucose
and
insulin
peaks
which
are
less
than
50%
of
those
produced
by
equivalent
amounts
of
glucose,
and
50
to
90%
of
those
produced
by
sucrose.
The
only
significant
clinical
effects
are
flatulence
and
diarrhea,
which
can
be
accounted
for
by
the
presence
of
free
and
bound
sorbitol.
The
mean
laxative
threshold
in
adult
males
is
approximately
180
grams
per
day,
while
in
females
the
threshold
is
approximately
100
grams
per
day.
In
children,
the
threshold
is
approximately
60
grams
per
day,
about
half
that
of
adults.
7.
Metabolite
toxicology.
None
of
the
metabolites
of
HSH
are
considered
to
be
of
toxicological
significance
for
the
use
of
this
product
as
a
pesticide
inert
ingredient.
8.
Endocrine
disruption.
Grain
Processing
Corporation
is
not
aware
of
any
endocrine
disruption
with
the
use
of
this
product.

C.
Aggregate
Exposure
1.
Dietary
exposure.
This
product
is
already
used
extensively
in
foods.
Studies
have
shown
that
it
is
safe
even
when
consumed
at
levels
of
up
to
100
g/
day.
i.
Food.
As
a
pesticide
inert
ingredient
HSH
will
not
result
in
any
harmful
exposure.
The
proposed
use
will
not
result
in
any
dietary
exposure
beyond
what
is
currently
present
in
commonly
consumed
foods.
ii.
Drinking
water.
There
is
no
anticipated
human
exposure
to
HSH
through
drinking
water.
HSH
is
expected
to
be
degraded
by
soil
microorganisms
to
carbon
dioxide
and
water
before
it
reaches
surface
or
ground
water.
Moreover,
in
water,
HSH
hydrolyses
to
glucose
and
sorbitol.
2.
Non­
dietary
exposure.
No
significant
non­
dietary
human
exposure
to
HSH
is
anticipated.

D.
Cumulative
Effects
HSH
is
a
widely
used
food
ingredient,
is
readily
digested
by
humans,
and
there
are
no
cumulative
effects.
Except
for
possible
occupational
exposure
of
the
pesticide
mixer/
loader/
applicator,
the
proposed
use
of
HSH
will
not
result
in
the
exposure
of
other
persons.
E.
Safety
Determination
1.
U.
S.
population.
The
proposed
use
of
HSH
does
not
pose
a
safety
concern
for
the
U.
S.
population
due
to
the
nontoxic
nature
of
the
compound
and
the
absence
of
exposure.
2.
Infants
and
children.
Infants
and
children
will
not
be
exposed
to
HSH
from
its
proposed
use
as
a
pesticide
inert
ingredient.

F.
International
Tolerances
Grain
Processing
Corporation
is
unaware
of
any
international
tolerances
for
this
product.
HSH
was
developed
by
a
Swedish
company
in
the
1960's
and
has
been
widely
used
by
the
food
industry
for
many
years,
especially
in
confectionery
products.
Roquette's
petition
indicates
that
Roquette's
Lycasin
products
have
been
approved
for
use
in
food
in
Europe
since
1963,
as
indicated
below.

Country
Year
of
Approval
Sweden
1963
(reaffirmed
in
1975)

Switzerland
1968
Norway
1975
Finland
1975
(reaffirmed
in
1980)

Denmark
1976
[FR
Doc.
02–
26993
Filed
10–
22–
02;
8:
45
am]

BILLING
CODE
6560–
50–
S
ENVIRONMENTAL
PROTECTION
AGENCY
[OPP–
2002–
0188;
FRL–
7199–
7]

Availability
of
the
Risk
Assessments
on
FQPA
Tolerance
Reassessment
Progress
and
Tolerance
Reassessment
Decision
(TRED)
for
Hexazinone
AGENCY:
Environmental
Protection
Agency
(EPA).

ACTION:
Notice.

SUMMARY:
This
notice
announces
the
availability
of
EPA's
tolerance
reassessment
decision
and
related
documents
for
hexazinone
including
the
Hexazinone
Overview,
Hexazinone
Summary,
Hexazinone
Decision
Document
(TRED),
and
supporting
risk
assessment
documents.
EPA
has
reassessed
the
25
tolerances,
or
legal
limits,
for
residues
of
hexazinone
in
or
on
raw
agricultural
commodities.
These
tolerances
are
now
considered
safe
under
the
Federal
Food,
Drug,
and
Cosmetic
Act
(FFDCA),
as
amended
by
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