Document ID: EPA-HQ-OPP-2002-0078-0001
Agency: epa
Document Type: Proposed Rule
Title: Notice of Filing a Pesticide Petition to Establish a Tolerance for a Certain Pesticide Chemical in or on Food.
Posted Date: 2002-06-03T04:00Z

[
Federal
Register:
June
3,
2002
(
Volume
67,
Number
106)]
[
Notices]
[
Page
38276­
38279]
From
the
Federal
Register
Online
via
GPO
Access
[
wais.
access.
gpo.
gov]
[
DOCID:
fr03jn02­
51]

­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­

ENVIRONMENTAL
PROTECTION
AGENCY
[
OPP­
2002­
0078;
FRL­
7179­
2]

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
[[
Page
38277]]

pesticide
chemical
in
or
on
various
food
commodities.

DATES:
Comments,
identified
by
docket
control
number
OPP­
2002­
0078,
must
be
received
on
or
before
July
3,
2002.

ADDRESSES:
Comments
may
be
submitted
by
mail,
electronically,
or
in
person.
Please
follow
the
detailed
instructions
for
each
method
as
provided
in
Unit
I.
C.
of
the
SUPPLEMENTARY
INFORMATION.
To
ensure
proper
receipt
by
EPA,
it
is
imperative
that
you
identify
docket
control
number
OPP­
2002­
0078
in
the
subject
line
on
the
first
page
of
your
response.

FOR
FURTHER
INFORMATION
CONTACT:
By
mail:
Shaja
Brothers,
Registration
Support
Branch,
Registration
Division
(
7505C),
Office
of
Pesticide
Programs,
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460;
telephone
number:
(
703)
308­
3194
and
e­
mail
address:
brothers.
shaja@
epa.
gov.

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

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

­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
Examples
of
Categories
NAICS
codes
potentially
affected
entities
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
Industry
111
Crop
production
112
Animal
production
311
Food
manufacturing
32532
Pesticide
manufacturing
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­

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
Additional
Information,
Including
Copies
of
this
Document
and
Other
Related
Documents?

1.
Electronically.
You
may
obtain
electronic
copies
of
this
document,
and
certain
other
related
documents
that
might
be
available
electronically,
from
the
EPA
Internet
Home
Page
at
http://
www.
epa.
gov/.
To
access
this
document,
on
the
Home
Page
select
  
Laws
and
Regulations,''
  
Regulations
and
Proposed
Rules,''
and
then
look
up
the
entry
for
this
document
under
the
  
Federal
Register''­­
Environmental
Documents.
You
can
also
go
directly
to
the
Federal
Register
listings
at
http://
www.
epa.
gov/
fedrgstr/.
2.
In
person.
The
Agency
has
established
an
official
record
for
this
action
under
docket
control
number
OPP­
2002­
0078
official
record
consists
of
the
documents
specifically
referenced
in
this
action,
any
public
comments
received
during
an
applicable
comment
period,
and
other
information
related
to
this
action,
including
any
information
claimed
as
confidential
business
information
(
CBI).
This
official
record
includes
the
documents
that
are
physically
located
in
the
docket,
as
well
as
the
documents
that
are
referenced
in
those
documents.
The
public
version
of
the
official
record
does
not
include
any
information
claimed
as
CBI.
The
public
version
of
the
official
record,
which
includes
printed,
paper
versions
of
any
electronic
comments
submitted
during
an
applicable
comment
period,
is
available
for
inspection
in
the
Public
Information
and
Records
Integrity
Branch
(
PIRIB),
Rm.
119,
Crystal
Mall
i2,
1921
Jefferson
Davis
Highway,
Arlington,
VA,
from
8:
30
a.
m.
to
4
p.
m.,
Monday
through
Friday,
excluding
legal
holidays.
The
PIRIB
telephone
number
is
(
703)
305­
5805.

C.
How
and
to
Whom
Do
I
Submit
Comments?

You
may
submit
comments
through
the
mail,
in
person,
or
electronically.
To
ensure
proper
receipt
by
EPA,
it
is
imperative
that
you
identify
docket
control
number
OPP­
2002­
0078
in
the
subject
line
on
the
first
page
of
your
response.
1.
By
mail.
Submit
your
comments
to:
Public
Information
and
Records
Integrity
Branch
(
PIRIB),
Information
Resources
and
Services
Division
(
7502C),
Office
of
Pesticide
Programs
(
OPP),
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460.
2.
In
person
or
by
courier.
Deliver
your
comments
to:
Public
Information
and
Records
Integrity
Branch
(
PIRIB),
Information
Resources
and
Services
Division
(
7502C),
Office
of
Pesticide
Programs
(
OPP),
Environmental
Protection
Agency,
Rm.
119,
Crystal
Mall
i2,
1921
Jefferson
Davis
Highway,
Arlington,
VA.
The
PIRIB
is
open
from
8:
30
a.
m.
to
4
p.
m.,
Monday
through
Friday,
excluding
legal
holidays.
The
PIRIB
telephone
number
is
(
703)
305­
5805.
3.
Electronically.
You
may
submit
your
comments
electronically
by
e­
mail
to:
opp­
docket@
epa.
gov,
or
you
can
submit
a
computer
disk
as
described
above.
Do
not
submit
any
information
electronically
that
you
consider
to
be
CBI.
Avoid
the
use
of
special
characters
and
any
form
of
encryption.
Electronic
submissions
will
be
accepted
in
Wordperfect
6.1/
8.0
or
ASCII
file
format.
All
comments
in
electronic
form
must
be
identified
by
docket
control
number
OPP­
2002­
0078.
Electronic
comments
may
also
be
filed
online
at
many
Federal
Depository
Libraries.

D.
How
Should
I
Handle
CBI
That
I
Want
to
Submit
to
the
Agency?

Do
not
submit
any
information
electronically
that
you
consider
to
be
CBI.
You
may
claim
information
that
you
submit
to
EPA
in
response
to
this
document
as
CBI
by
marking
any
part
or
all
of
that
information
as
CBI.
Information
so
marked
will
not
be
disclosed
except
in
accordance
with
procedures
set
forth
in
40
CFR
part
2.
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
version
of
the
official
record.
Information
not
marked
confidential
will
be
included
in
the
public
version
of
the
official
record
without
prior
notice.
If
you
have
any
questions
about
CBI
or
the
procedures
for
claiming
CBI,
please
consult
the
person
identified
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
control
number
assigned
to
this
action
in
the
subject
line
on
the
first
page
of
your
[[
Page
38278]]

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
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:
May
17,2002.
Robert
Forrest,
Acting
Director,
Registration
Division,
Office
of
Pesticide
Programs.

Summary
of
Petition
The
petitioner
summary
of
the
pesticide
petition
is
printed
below
as
required
by
section
408(
d)(
3)
of
the
FFDCA.
The
summary
of
the
petition
was
prepared
by
the
Interregional
Research
Project
Number
4,
and
represents
the
view
of
the
Interreional
Research
Project.
EPA
is
publishing
the
petition
summary
verbatim
without
editing
it
in
any
way.
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
1E6322
EPA
has
received
a
pesticide
petition
(
1E6322)
from
the
Interregional
Research
Project
Number
4,
681
U.
S.
Highway
1
South,
North
Brunswick,
New
Jersey
08902­
3390]
proposing,
pursuant
to
section
408(
d)
of
the
FFDCA,
21
U.
S.
C.
346a(
d),
to
amend
40
CFR
180.479
by
establishing
a
tolerance
for
residues
of
the
herbicide
[
halosulfuron,
methyl
5­[(
4,6­
dimethoxy­
2­
pyrimidinyl)
amino]
carbonylaminosulfonyl­
3­
chloro­
1­
methyl­
1H­
pyrazole­
4­
carboxylate]
in
or
on
the
raw
agricultural
commodities
(
RAC)
dry
bean
and
succulent
snap
bean
at
0.05
parts
per
million
(
ppm).
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.
This
notice
includes
a
summary
of
the
petition
prepared
by
Gowan
Company,
Yuma,
Arizona
85366.

A.
Residue
Chemistry
1.
Plant
metabolism.
The
metabolism
of
halosulfuron­
methyl
as
well
as
the
nature
of
the
residues
in
plants
is
adequately
understood
for
purposes
of
this
tolerance.
2.
Analytical
method.
A
practical
analytical
method,
gas
chromatography
with
a
nitrogen
specific
detector
(
TSD)
which
detects
and
measures
residues
of
halosulfuron­
methyl,
is
available
for
enforcement
purposes
with
a
limit
of
detection
that
allows
monitoring
of
food
with
residues
at
or
above
the
levels
set
in
these
tolerances.
This
enforcement
method
has
been
submitted
to
the
Food
and
Drug
Administration
for
publication
in
the
Pesticide
Analytical
Manual
(
PAM
II).
It
has
undergone
independent
laboratory
validation
and
validation
at
the
Beltsville
laboratory.
3.
Magnitude
of
residues.
In
snap
and
dry
bean
residue
studies,
there
were
no
quantifiable
residues
found
in
the
RAC
using
an
analytical
method
with
limit
of
quantitation
(
LOQ)
of
0.05
ppm.

B.
Toxicological
Profile
The
nature
of
the
toxic
effects
caused
by
halosulfuron­
methyl
is
discussed
in
unit
II.
B
of
the
Federal
Register
on
April
31,
2001
(
66
FR
45993)
(
FRL­
6796­
1).

C.
Aggregate
Exposure
1.
Dietary
exposure.
Tolerances
have
been
established
(
40
CFR
180.479)
for
residues
of
halosulfuron­
methyl
in
or
on
a
variety
of
plant
and
animal
RACs.
i.
Food­­
a.
Acute
exposure.
For
purposes
of
assessing
the
potential
dietary
exposure
from
food
under
existing
and
proposed
tolerances,
the
aggregate
exposure
is
based
on
the
Theoretical
Maximum
Residue
Contribution
(
TMRC)
which
is
an
estimate
of
the
level
of
residues
consumed
daily
if
each
food
item
contained
pesticide
residues
equal
to
the
tolerance.
The
calculated
TMRC
value
using
the
99.9th
percentile
consumption
data
was
0.006
milligrams/
kilograms
bodyweight
day
(
mg/
kg
bwt
day)
or
1.2%
acute
Reference
Dose
(
aRfD)
for
the
general
U.
S.
population.
TMRC
is
obtained
by
multiplying
the
tolerance
levels
for
each
commodity
by
the
daily
consumption
of
the
food
forms
of
that
commodity
eaten
by
the
U.
S.
population
and
various
population
subgroups.
In
conducting
this
exposure
assessment,
conservative
assumptions
were
made
resulting
in
a
large
overestimate
of
human
exposure.
Thus,
the
dietary
exposures
to
halosulfuron­
methyl
are
less
3.0%
aRfD
for
all
sub­
populations.
Food
consumption
data
from
DEEM
software
were
used
in
the
calculation.
b.
Chronic
exposure.
The
chronic
Reference
Dose
(
cRfD)
is
0.1
mg/
kg/
day.
For
all
established
and
proposed
tolerances
of
halosulfuron­
methyl,
the
calculated
TMRC
value
for
the
U.
S.
population
is
0.00049
mg/
kg/
day
or
0.5%
RfD.
ii.
Drinking
water.
The
estimated
environmental
concentrations
(
EECs)
in
ground
water
(
acute
and
chronic)
is
0.008
[
mu]
g/
L.
The
estimated
EECs
(
acute
and
chronic)
for
surface
water
are
4.3
[
mu]
g/
L
and
1.1
[
mu]
g/
L,
respectively.
These
estimates
are
based
on
a
maximum
application
rate
of
0.063
lbs.
active
per
acre,
which
may
be
applied
twice
per
season.
There
is
no
Maximum
Contaminant
Level
(
MCL)
established
for
residues
of
halosulfuron­
methyl.
2.
Non­
dietary
exposure.
The
non­
dietary
exposure
assessment
for
halosulfuron­
methyl
is
discussed
in
unit
II.
C
of
the
Federal
Register
on
April
31,
2001
(
66
FR
45993)
(
FRL­
6796­
1).

D.
Cumulative
Effects
The
potential
for
cumulative
effects
for
halosulfuron­
methyl
is
discussed
in
unit
II.
D
of
the
Federal
Register
on
April
31,
2001
(
66
FR
45993)
(
FRL­
6796­
1).

E.
Safety
Determination
1.
U.
S.
population.
Aggregate
chronic
exposure
to
halosulfuron­
methyl
from
  
food
only''
utilizes
less
than
1%
of
the
chronic
populated
adjusted
dose
(
cPAD)
for
the
most
sensitive
subgroup,
children
(
1­
6
years).
The
lowest
drinking
water
level
of
concern
(
DWLOC)
calculated
was
1,000
[
mu]
g/
L
for
infants
and
children
which
is
significantly
higher
than
the
EEC
for
chronic
ground
water
(
0.008
[
mu]
g/
L)
and
surface
water
(
1.1
[
mu]
g/
L).
As
a
result,
the
aggregate
risk
from
chronic
exposure
to
halosulfuron­
methyl
residues
from
all
anticipated
dietary
exposures
does
not
pose
appreciable
risks
to
human
health.
Short­
term
risk­­
short­
term
aggregate
exposure
takes
into
account
chronic
dietary
food
and
water
plus
short­
term
residential
exposure.
For
halosulfuron­
methyl,
the
EPA
has
determined
that
it
is
appropriate
to
aggregate
exposure
via
[[
Page
38279]]

oral
exposure
route
(
food
and
water)
with
those
via
oral
and
dermal
exposure
routes
from
residential
uses.
The
MOEs
for
  
food
only''
and
residential
exposure
routes
are
113,
600,
and
330
for
females
13+
years.
Short­
term
DWLOC
for
females
13+
is
10,000
[
mu]
g/
L
which
is
substantially
higher
than
the
EECs
for
acute
surface
water
(
4.3
[
mu]
g/
L).
The
food
only
and
residential
(
oral
and
dermal)
MOEs
are
well
above
the
acceptable
short­
term
aggregate
MOE
of
100.
Therefore,
exposure
to
halosulfuron­
methyl
residues
resulting
from
current
and
proposed
uses
does
not
pose
a
short­
term
aggregate
risk.
Intermediate­
term
risk­­
intermediate­
term
aggregate
exposure
takes
into
account
chronic
dietary
food
and
water
plus
intermediate­
term
residential
exposure.
The
MOEs
for
  
food
only''
and
residential
exposure
routes
are
22,800
and
120
for
adult
males,
and
23,000
and
100
for
females
13+
years.
The
intermediate­
term
DWLOCs
are
590
[
mu]
g/
L
and
57
[
mu]
g/
L,
respectively,
for
adult
males
and
females
13+.
Intermediate­
term
DWLOCs
are
substantially
higher
than
the
EEC
for
chronic
surface
water
(
1.1
[
mu]
g/
L).
The
food
only
and
residential
(
dermal)
MOEs
are
above
the
acceptable
short­
term
aggregate
MOE
of
100.
Therefore,
exposure
to
halosulfuron­
methyl
residues
resulting
from
current
and
proposed
uses
does
not
pose
a
intermediate­
term
aggregate
risk.
Halosulfuron­
methyl
has
been
classified
as
a
Group
E
chemical
based
upon
the
lack
of
evidence
of
carcinogenicity
in
mice
and
rats,
and
has
been
classified
as
not
likely
to
be
a
human
carcinogen.
Therefore
based
upon
this
risk
assessment,
there
is
reasonable
certainty
that
no
harm
will
result
from
aggregate
exposure
to
halosulfuron­
methyl
residues
resulting
from
current
and
proposed
uses.
2.
Infants
and
children.
FFDCA
section
408
provides
that
EPA
may
apply
an
additional
safety
factor
(
up
to
10)
in
the
case
of
threshold
effects
for
infants
and
children
to
account
for
pre­
natal
and
post­
natal
toxicity
and
the
completeness
of
the
data
base.
Except
for
the
pending
request
for
a
developmental
neurotoxicity
study,
the
toxicity
data
base
is
complete
for
halosulfuron­
methyl.
The
chronic
RfD
was
determined
to
be
0.1
mg/
kg/
day
based
upon
the
chronic
dog
study.
The
percent
of
RfD
occupied
is
0.9%
for
the
most
sensitive
population
subgroup,
children
(
1­
6
years
old).
The
DWLOC
for
chronic
exposure
for
infants
and
children
is
1,000
[
mu]
g/
L
and
is
significantly
greater
than
the
maximum
concentration
of
halosulfuron­
methyl
in
drinking
water
(
0.008
[
mu]
g/
L
in
ground
water
and
1.1
[
mu]
g/
L
in
surface
water).
Based
upon
reliable
toxicity
data,
the
use
of
an
additional
10X
safety
factor
is
not
warranted.
Dietary
assessments
do
not
indicate
a
level
of
concern
for
potential
risks
to
infants
and
children
based
upon
the
low
use
rates
of
halosulfuron­
methyl,
and
the
results
of
field
and
animal
RAC
studies
conclude
that
detectable
residues
are
not
expected
in
human
foods.
Therefore,
based
on
complete
and
reliable
toxicity
data
and
the
conservative
exposure
assessment,
it
is
concluded
that
there
is
reasonable
certainty
that
no
harm
will
result
to
infants
and
children
from
aggregate
exposure
to
halosulfuron­
methyl
residues
with
respect
to
the
proposed
new
uses
on
dry
and
succulent
snap
beans.

F.
International
Tolerances
Maximum
residue
levels
have
not
been
established
for
residues
of
halosulfuron­
methyl
on
any
food
or
feed
crop
by
the
Codex
Alimentarius
Commission.
[
FR
Doc.
02­
13814
Filed
5­
31­
02
8:
45
am]
BILLING
CODE
6560­
50­
S