Document ID: EPA-HQ-OPP-2003-0051-0001
Agency: epa
Document Type: Notice
Title: Ammonium Thiosulfate; Notice of Filing a Pesticide Petition to Establish a Tolerance for a Certain Pesticide Chemical in or on Food
Posted Date: 2003-03-05T05:00Z

10474
Federal
Register
/
Vol.
68,
No.
43
/
Wednesday,
March
5,
2003
/
Notices
ENVIRONMENTAL
PROTECTION
AGENCY
[
OPP
 
2003
 
0051;
FRL
 
7294
 
3]

Ammonium
Thiosulfate;
Notice
of
Filing
a
Pesticide
Petition
to
Establish
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
 
2003
 
0051,
must
be
received
on
or
before
April
4,
2003.
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:
Jim
Tompkins,
Registration
Division
(
7505C),
Office
of
Pesticide
Programs,
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460
 
0001;
telephone
number:
(
703)
305
 
5697;
e­
mail
address:
tompkins.
jim]@
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:
 
Industry
(
NAICS
111)
 
Crop
production
(
NAICS
112)
 
Animal
production
(
NAICS
311)
 
Food
manufacturing,
and
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
(
ID)
number
OPP
 
2003
 
0051.
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
on
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
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Register
/
Vol.
68,
No.
43
/
Wednesday,
March
5,
2003
/
Notices
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
 
2003
 
0051.
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
 
2003
 
0051.
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
 
2003
 
0051.
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
 
2003
 
0051.
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:
February
20,
2003.
Debra
Edwards,
Acting
Director,
Registration
Division,
Office
of
Pesticide
Programs.

Summary
of
Petition
The
petitioner's
summary
of
the
pesticide
petition
is
printed
below
as
required
by
FFDCA
section
408(
d)(
3).
The
summary
of
the
petition
was
prepared
by
Siemer
and
Associates
Inc.,
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.

Siemer
and
Associates,
Inc.

PP
6F4789
EPA
has
received
a
pesticide
petition
(
PP
6F4789)
from
Siemer
and
Associates,
Inc.
on
behalf
of
National
Chelating,
4672
West
Jennifer,
Suite
103,
Fresno,
CA
93722,
proposing
pursuant
to
section
408(
d)
of
the
Federal
Food,
Drug
and
Cosmetic
Act,
21
U.
S.
C.
346a(
d),
to
amend
40
CFR
part
180
by
establishing
an
exemption
from
the
requirements
for
a
tolerance
for
ammonium
thiosulfate
when
used
for
blossom
thinning
on
apples.
Pursuant
to
the
section
408(
d)(
2)(
A)(
i)
of
the
FFDCA,
as
amended,
Siemer
and
Associates,
Inc.,
on
behalf
of
National
Chelating
has
submitted
the
following
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/
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68,
No.
43
/
Wednesday,
March
5,
2003
/
Notices
summary
of
information,
data
and
arguments
in
support
of
their
pesticide
petition.
This
summary
was
prepared
by
Siemer
and
Associates,
Inc.,
and
EPA
has
not
fully
evaluated
the
merits
of
the
petition.
EPA
edited
the
summary
to
clarify
that
the
conclusions
and
arguments
were
the
petitioner's
and
not
necessarily
EPA's
and
to
remove
certain
extraneous
material.
On
August
30,
1996
Siemer
and
Associates
on
behalf
of
National
Chelating
petitioned
EPA,
under
pesticide
petition
6F4789,
for
a
permanent
exemption
from
the
requirements
of
a
tolerance
for
ammonium
thiosulfate
on
apples.
Section
408(
b)(
2)(
A)
of
the
amended
Federal
Food,
Drug,
and
Cosmetic
Act
allows
the
EPA
to
establish
an
exemption
from
the
requirements
for
a
tolerance
only
if
the
Administrator
determines
that
there
is
a
``
reasonable
certainty
that
no
harm
will
result
from
the
aggregate
exposure
to
the
pesticide
chemical
residue,
including
all
anticipated
dietary
exposures
and
all
other
exposures
for
which
there
is
reliable
information.''
The
available
information
indicates
that
there
is
a
reasonable
certainty
that
no
harm
will
result
from
various
types
of
exposure.
Requests
for
waivers
from
the
requirements
of
performing
studies
for
known
chemistry
are
presented
and
substantiated.
The
following
is
a
summary
of
the
information
submitted
to
EPA,
to
support
the
establishment,
under
Section
408(
b)(
2)(
D)
of
the
amended
FFDCA,
of
a
tolerance
for
ammonium
thiosulfate
on
apples.

A.
Residue
Chemistry
1.
Plant
metabolism.
The
qualitative
nature
of
the
residues
of
ammonium
thiosulfate
in
apple
is
adequately
understood.
The
requirement
for
residue
studies
was
waived
by
EPA
based
on
the
knowledge
that
ammonium
thiosulfate
has
been
used
as
a
soil
applied
and
foliar
applied
fertilizer
for
many
years.
Prior
experience
and
numerous
publications
teach
that
ammonium
thiosulfate
ionizes
when
placed
into
water,
forming
an
ammonium
ion
and
a
thiosulfate
ion
which
further
degrades
to
form
elemental
sulfur
and
a
sulfate
ion.
The
sulfur
is
further
oxidized
to
form
a
sulfate
ion.
The
ammonium
and
sulfate
ions
thus
formed
are
absorbed
into
the
growing
plant
and
moved
into
the
naturally
occurring
nitrogen
and
sulfate
pools
that
occur
naturally
in
growing
plants.
Once
applied
to
the
plant,
without
isotope
identification,
it
is
not
possible
to
separate
the
ammonium
and
sulfate
ions
that
will
occur
from
those
that
already
occur
naturally
in
the
plant.
On
this
basis,
an
exemption
from
the
requirements
of
a
tolerance
is
justified.
There
is
no
analytical
method
needed
since
there
is
no
practical
way
to
separate
the
ammonium
and
sulfate
ions
from
those
that
naturally
occur.
2.
Analytical
method.
The
need
for
an
analytical
method
is
waived
on
the
basis
that
there
is
no
need
for
analyzing
for
the
component
of
ammonium
and
sulfate
ion
applied
for
blossom
thinning
purposes.
3.
Magnitude
of
residues.
No
residues
of
ammonium
thiosulfate
will
be
identified
separately
from
those
ammonium
and
sulfate
ions
naturally
occurring.
This
result
supports
the
proposed
exemption
from
the
requirements
for
a
tolerance.

B.
Toxicological
Profile
A
request
to
waive
the
battery
of
mammalian
toxicity
studies
for
ammonium
thiosulfate
is
based
on
and
justified
by
the
following:
1.
Acute
toxicity.
Based
on
EPA
criteria,
ammonium
thiosulfate
previously
registered
for
a
non­
food
use
as
an
ornamental
herbicide
has
been
shown
to
be
relatively
non­
toxic
and
has
been
registered
for
non­
food
use
purposes
as
a
Category
III
herbicide.
These
data
have
previously
been
supplied
to
the
agency.
2.
Genotoxicity.
A
request
for
a
waiver
from
the
following
requirements
is
made
on
the
basis
that
sodium
thiosulfate
is
on
the
Food
and
Drug
Administration's
Generally
Recognized
as
Safe
(
GRAS)
list
at
21
CFR
184.1807,
and
ammonium
thiosulfate
is
already
exempted
from
the
requirements
of
a
tolerance
when
used
in
accordance
with
good
agricultural
practices
as
inert
(
or
occasionally
active)
ingredients
in
pesticide
formulations
applied
to
growing
crops
or
to
raw
agricultural
commodities
after
harvest
(
at
40
CFR
180.1001(
c)).
Ammonium
thiosulfate
ionizes
to
form
ammonium
ion
and
thiosulfate
ion
in
water
with
neither
of
these
ions
being
mutagenic
or
genotoxic.
On
that
basis
the
following
tests
are
requested
to
be
waived.
i.
Gene
Mutation
­
Ames.
ii.
In
vitro
Structural
chromosomal
aberration
assay.
iii.
In
vitro
CHO/
HGPRT
assay.
iv.
In
vivo
micronucleus
aberration
assay.
3.
Reproductive
and
developmental
toxicity.
A
request
for
waiving
the
data
requirements
for
the
following
is
made
on
the
basis
of
the
discussion
in
paragraph
B.
above.
In
addition,
all
of
the
tests
listed
below
rely
on
feeding
the
test
substance,
to
animals
that
have
acidic
stomachs.
Placing
ammonium
thiosulfate
into
an
acidic
environment
will
cause
near
instantaneous
ion
formation
giving
rise
to
ammonium
and
thiosulfate
ions,
which
ultimately
breaks
down
to
elemental
sulfur
and
sulfite.
These
sulfur
forms
will
be
quickly
oxidized
under
acidic
conditions
to
sulfate,
which
will
be
incorporated
into
the
normal
sulfate
pool
that
exists
within
the
metabolic
system
of
the
various
animal
test
systems.
The
ammonium
ion
will
react
with
the
acidic
component,
most
likely
forming
ammonium
chloride
which
will
be
metabolized
in
a
well
understood
pathway
in
the
systems
of
the
various
animal
test
systems.
The
new
moiety
formed
in
this
acidic
medium
is
the
sulfite
ion
which
also
is
well
understood
and
is
quickly
oxidized
to
sulfate.
The
FDA
instituted
studies
in
1975
and
1985
on
the
GRAS
status
of
sulfite
and,
as
a
result
of
these
studies,
has
substantiated
the
GRAS
status
except
for
a
few
individuals
that
might
be
allergic
to
sulfite.
In
this
proposed
usage,
however,
the
sulfite
will
not
reach
the
possibly
allergic
people,
since
the
sulfite
will
be
metabolized
to
sulfate
in
the
plant
system
before
reaching
any
sensitive
people
who
may
consume
the
treated
tissue.
The
data
waivers
requested
are
as
follows:
i.
Teratology
in
rats.
ii.
Teratology
in
rabbits.
iii.
2­
Generation
reproduction
in
rats.
4.
Subchronic
toxicity.
The
data
requirements
listed
below
are
requested
to
be
waived
on
the
basis
illustrated
above
at
paragraph
B.
3.
i.
28
 
Day
dermal
in
rats.
ii.
13
 
Week
oral
feeding
in
rats.
iii.
90
 
Day
oral
feeding
in
dogs.
5.
Chronic
toxicity.
The
data
requirements
listed
below
are
requested
to
be
waived
for
reasons
listed
above
at
paragraph
B.
3.
i.
1
 
Year
chronic
toxicity
in
dogs.
ii.
18
 
month
chronic
toxicity
and
carcinogenicity
in
mice.
iii.
24
 
month
chronic
toxicity
and
carcinogenicity
in
rats.
6.
Animal
metabolism.
The
metabolism
of
ammonium
thiosulfate
is
well
understood
in
animals.
As
listed
above,
this
substance
rapidly
ionizes
in
the
acidic
portion
of
the
animal
gut,
giving
rise
to
ammonium
ion
and
sulfate
ion.
Both
of
these
substances
are
required
and
occur
in
the
metabolism
of
animals.
7.
Metabolite
toxicology.
No
toxicologically
significant
metabolites
will
be
detected
in
plant
or
animal
metabolism
studies
using
ammonium
thiosulfate.
Therefore,
no
metabolites
are
required
to
be
regulated.
8.
Endocrine
effects.
There
is
no
information
available
that
suggest
that
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Notices
ammonium
thiosulfate
would
be
associated
with
endocrine
effects.

C.
Aggregate
Exposure
1.
Dietary
exposure
 
i
Food.
There
will
be
no
residues
of
ammonium
thiosulfate
that
will
reach
any
portion
of
the
U.
S.
population
as
a
result
of
using
ammonium
thiosulfate
as
a
blossom
thinner
on
apples.
The
ammonium
and
sulfate
ions
that
will
arise
will
not
be
different
from
the
naturally
occurring
forms
of
the
ions,
which
exceed
by
far
the
amount
that
will
be
applied
as
a
result
of
the
use
of
the
ammonium
thiosulfate.
ii.
Drinking
water.
Ammonium
and
sulfate
ions
that
arise
from
ammonium
thiosulfate
use
will
add
no
additional
burden
to
the
drinking
water.
The
end
points
of
the
two
ions
formed
as
a
result
of
ammonium
thiosulfate
use
will
both
be
used
in
plant
nutrition.
The
ammonium
form
of
nitrogen
resists
leaching
by
binding
to
the
colloid
fraction
in
the
soil
to
resist
ground
water
contamination.
The
amount
of
sulfate
added
as
a
result
of
the
described
use
will
add
an
imperceptible
amount
to
the
sulfate
level
already
in
existence
in
the
soil.
There
is
a
reasonable
certainty
that
no
harm
will
result
from
dietary
exposure
to
ammonium
thiosulfate,
because
dietary
exposures
to
residues
on
food
cannot
be
differentiated
from
those
that
will
occur
naturally
in
food,
and
exposure
through
drinking
water
is
expected
to
be
insignificant.
2.
Non­
dietary
exposure.
There
is
no
non­
dietary
exposure
expected,
since
any
ammonium
thiosulfate
finding
its
way
onto
the
plants
or
around
any
plants
will
be
absorbed
and
metabolized
into
naturally
occurring
plant
constituents.

D.
Cumulative
Effects
There
are
no
cumulative
effects
expected
since
the
ammonium
thiosulfate
metabolites
are
all
incorporated
into
naturally
occurring
constituents
found
in
all
plant
systems.

E.
Safety
Determination
1.
U.
S.
population.
The
natural
occurrence
of
the
metabolites
of
the
ammonium
and
sulfate
ions
in
all
plants
and
in
humans
is
the
basis
for
the
Generally
Recognized
As
Safe
characterization
of
the
thiosulfate
ion
and
the
use
of
the
ammonium
ion
as
a
component
in
nearly
all
fertilizers,
supports
the
conclusion
that
there
is
a
``
reasonable
certainty
of
no
harm''
from
aggregate
exposure
to
ammonium
thiosulfate.
2.
Infants
and
children.
No
developmental,
reproductive
or
fetotoxic
effects
have
been
associated
with
ammonium
thiosulfate
and
its
use
as
a
fertilizer.
The
calculation
of
safety
margins
with
respect
to
ammonium
thiosulfate
is
unnecessary
since
the
ammonium
and
sulfate
ions
that
will
arise
from
the
use
of
ammonium
thiosulfate
will
add
only
slightly
to
the
already
naturally
occurring
nitrogen
and
sulfur
pools
in
existence
in
various
plants.
Since
there
will
be
no
residues
of
toxicological
significance
resulting
from
ammonium
thiosulfate,
calculations
of
safety
margins
are
not
necessary
based
on
the
lack
of
any
unnatural
residues.

F.
International
Tolerances
There
is
no
codex
maximum
residue
level
established
for
ammonium
thiosulfate
on
apple.
However,
ammonium
thiosulfate
is
widely
used
as
a
nutrient
in
many
parts
of
the
world.
[
FR
Doc.
03
 
5036
Filed
3
 
4
 
03;
8:
45
am]

BILLING
CODE
6560
 
50
 
S
ENVIRONMENTAL
PROTECTION
AGENCY
[
OPP
 
2002
 
0305;
FRL
 
7281
 
6]

Pesticides;
Final
Guidance
for
Pesticide
Registrants
on
Labeling
of
Pesticide
Products
Under
the
National
Organic
Program
AGENCY:
Environmental
Protection
Agency
(
EPA).
ACTION:
Notice
of
availability.

SUMMARY:
The
Agency
is
announcing
the
availability
of
a
pesticide
registration
notice
(
PR
Notice)
titled
``
Labeling
of
Pesticide
Products
Under
the
National
Organic
Program.''
This
PR
Notice
was
issued
by
the
Agency
on
January
31,
2003
and
is
identified
as
PR
Notice
2003
 
1.
PR
Notices
are
issued
by
the
Office
of
Pesticide
Programs
(
OPP)
to
inform
pesticide
registrants
and
other
interested
persons
about
important
policies,
procedures,
and
registration
related
decisions,
and
serve
to
provide
guidance
to
pesticide
registrants
and
OPP
personnel.
This
particular
final
PR
Notice
provides
guidance
to
the
registrant
concerning
obtaining
EPA
approval
of
pesticide
product
label
language
indicating
that
all
ingredients
(
active
and
inert)
in
a
pesticide
product
and
all
uses
of
that
pesticide
product
meet
the
criteria
defined
in
the
National
Organic
Program
Rule.
This
notice
is
being
issued
because
of
registrant
requests
to
be
able
to
identify,
on
pesticide
product
labels,
pesticide
products
that
are
allowable
under
the
National
Organic
Program.
FOR
FURTHER
INFORMATION
CONTACT:
Robert
Torla,
Biopesticides
and
Pollution
Prevention
Division
(
7511C),
Office
of
Pesticide
Programs,
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460
 
0001;
telephone
number:
(
703)
308
 
8098;
fax
number:
(
703)
308
 
7026;
e­
mail
address:
torla.
robert@
epa.
gov.

SUPPLEMENTARY
INFORMATION:

I.
Does
this
Action
Apply
to
Me?
This
action
is
directed
to
the
public
in
general.
Although
this
action
may
be
of
particular
interest
to
those
persons
who
wish
to
consider
including
language
on
their
pesticide
labeling
identifying
their
pesticide
product
as
allowable
under
the
National
Organic
Program.
Since
other
entities
may
also
be
interested,
the
Agency
has
not
attempted
to
describe
all
the
specific
entities
that
may
be
affected
by
this
action.
If
you
have
any
questions
regarding
the
information
in
this
notice,
consult
the
person
listed
under
FOR
FURTHER
INFORMATION
CONTACT.

II.
What
Guidance
Does
this
PR
Notice
Provide?
This
PR
Notice
provides
guidance
to
the
registrant
concerning
how
registrants
may
obtain
EPA
approval
of
label
language
indicating
that
all
ingredients
(
active
and
inert)
in
a
pesticide
product
and
all
uses
of
that
product
meet
the
criteria
defined
in
the
National
Organic
Program
Rule
(
7
CFR
part
205).
This
notice
provides
information
on:
1.
The
conditions
which
must
be
met
for
approval
of
the
label
language.
2.
An
example
of
acceptable
label
language.
3.
Guidance
on
materials
to
be
submitted
for
Agency
review.
4.
Guidance
for
inserting
label
language
on
pesticide
products
exempted
from
FIFRA
regulation
under
40
CFR
152.25.

III.
Do
PR
Notices
Contain
Binding
Requirements?
The
PR
Notice
discussed
in
this
notice
is
intended
to
provide
guidance
to
EPA
personnel
and
decision
makers
and
to
pesticide
registrants.
While
the
requirements
in
the
statutes
and
Agency
regulations
are
binding
on
EPA
and
the
applicants,
this
PR
Notice
is
not
binding
on
either
EPA
or
pesticide
registrants,
and
EPA
may
depart
from
the
guidance
where
circumstances
warrant
and
without
prior
notice.
Likewise,
pesticide
registrants
may
assert
that
the
guidance
is
not
appropriate
generally
or
not
applicable
to
a
specific
pesticide
or
situation.

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