Document ID: EPA-HQ-OPP-2002-0341-0001
Agency: epa
Document Type: Notice
Title: Boscalid; Notice of Filing a Pesticide Petition to Establish a Tolerance for a Certain Pesticide               Chemical in or on Food
Posted Date: 2003-02-14T05:00Z

7542
Federal
Register
/
Vol.
68,
No.
31
/
Friday,
February
14,
2003
/
Notices
5.
If
there
is
relevance
to
your
project,
briefly
describe
the
Tribal
and
non­
Tribal
populations
of
surrounding
counties/
States,
and
surrounding
land
use.
6.
How
many
people
(
Tribal/
non­
Tribal)
are
employed
by
the
Tribal
Government
(
e.
g.,
in
government
services,
including
health
care,
police
and
fire
protection).
7.
How
many
are
employed
on
the
reservation
in
other
areas
that
use
pesticides
or
may
be
impacted
by
their
use
(
e.
g.,
agriculture,
animal
husbandry,
fisheries/
fishing,
forestry,
construction,
casinos/
resorts/
golf
course
maintenance)?
8.
If
you
are
concerned
about
pesticide
pollution
that
may
originate
within
reservation
boundaries,
what
are
the
potential
sources
and
what
chemicals
might
be
involved?
9.
If
you
are
concerned
with
pollution
migration
from
off­
reservation
sources,
what
are
those
potential
sources,
and
what
chemicals
are
of
specific
concern?
10.
Is
the
Tribe
concerned
about
water
quality
issues?
If
so,
please
describe
the
nature
of
these
concerns.
11.
Does
the
Tribe
currently
have
any
pesticide
policy
in
place?
Selection
criteria
Total
possible
points:
100
Technical
Qualifications,
Overall
Management
Plan,
Past
Performance
(
30
Points)
Does
the
person(
s)
designated
to
lead
the
project
have
the
technical
expertise
he
or
she
will
need
to
successfully
complete
it?
Does
the
project
leader
have
experience
in
grant
and
project
management?
Proposals
should
provide
complete
information
on
the
education,
skills,
training
and
relevant
experience
of
the
project
leader.
As
appropriate,
please
cite
technical
qualifications
and
specific
examples
of
prior,
relevant
experience.
If
this
project
will
develop
new
Tribal
capacity,
describe
how
the
project
leader
and/
or
staff
will
gain
necessary
training
and
expertise.
To
whom
does
the
project
leader
report?
What
systems
of
accountability
and
management
oversight
are
in
place
to
ensure
this
project
stays
on
track?
Has
the
Tribe
or
Tribal
consortium
received
past
funding
from
EPA's
Office
of
Pesticide
Programs,
other
EPA
programs,
or
other
sources?
If
so,
please
identify
the
funding
source
and
activities/
deliverables
it
supported.
If
previously
performed
work
directly
impacts
this
project,
briefly
describe
the
connection.
If
a
directly
relevant
project
is
currently
ongoing,
what
progress
has
been
made?
If
this
new
project
builds
upon
earlier
efforts,
how
will
you
use
the
knowledge,
data,
and
experience
of
grant
outputs
from
previous
projects
to
shape
this
new
proposed
activity?
Justification
for
Need
of
the
Project,
Soundness
of
Technical
Approach
(
35
Points)
Why
is
this
project
important
to
the
Tribe
or
the
Tribal
consortium?
What
environmental
issues(
s)
will
it
address
and
how
serious
and/
or
pervasive
are
these
issues?
What
is
the
expected
outcome
of
the
project?
What
benefits
will
this
project
provide
to
the
Tribe,
human
health,
and
the
environment?
Has
the
Tribe
identified
a
need
to
coordinate
or
consult
with
other
parties
(
Tribal
and/
or
non­
Tribal)
to
ensure
the
success
of
this
project?
If
so,
who
are
they?
How
does
the
Tribe
plan
to
involve
these
parties?
How
will
they
be
affected
by
the
outcome
of
the
project?
What
are
the
key
outputs
of
this
project?
How
do
you
propose
to
quantify
and
measure
progress?
Have
interim
milestones
for
this
project
been
established?
If
so,
what
are
they?
How
will
you
evaluate
the
success
of
the
project
in
terms
of
measurable
environmental
results?
Please
describe
the
steps
you
will
take
to
ensure
successful
completion
of
the
project
and
provide
a
time
line
and
description
of
interim
and
final
results
and
deliverables.
Does
your
budget
request
accurately
reflect
the
work
you
propose?
Please
provide
a
clear
correlation
between
expenses
and
project
objectives.
Will
EPA
funding
for
this
project
be
supplemented
with
funding
from
other
source(
s)?
If
so,
please
identify
them.
Benefits,
Sustainability,
Transferable
Results
(
35
Points)
What
ecological
or
human
health
benefits
does
this
project
provide?
What
quality
of
life
issues
does
the
project
address?
Does
the
project
have
limited
or
broad
application
to
address
risks
related
to
pesticides?
Will
the
results
from
this
project
continue
to
provide
benefits
to
the
Tribe
or
other
Tribes
after
the
period
of
performance
has
expired
and
this
funding
is
no
longer
available?
How
are
the
benefits
of
this
effort
expected
to
be
sustained
over
time?
Does
the
applicant
understand/
acknowledge
the
need
for
coordination
between
Tribal
agencies
and
outside
communities,
and/
or
Federal,
State
or
local
agencies?
Will
the
project
help
build
Tribal
infrastructure
or
capacity?
How?
Can
the
project
results
be
incorporated
into
existing
and/
or
future
pesticide­
related
Tribal
environmental
activities?
Are
any
of
the
deliverables,
experiences,
products,
or
outcomes
resulting
from
the
project
transferable
to
other
communities?
Might
this
project
readily
be
implemented
by
another
Tribe?

VII.
Post
Selection
Activity
Selected
applicants
must
formally
apply
for
funds
through
the
appropriate
EPA
regional
office.
In
addition,
selected
applicants
must
negotiate
a
final
work
plan,
including
reporting
requirements,
with
the
designated
EPA
regional
project
officer.
For
more
general
information
on
post
award
requirements
and
the
evaluation
of
grantee
performance,
see
40
CFR
part
31.

VIII.
Submission
to
Congress
and
the
Comptroller
General
Grant
solicitations
such
as
this
are
considered
rules
for
the
purpose
of
the
Congressional
Review
Act
(
CRA).
The
CRA,
5
U.
S.
C.
801
et
seq.,
as
added
by
the
Small
Business
Regulatory
Enforcement
Fairness
Act
of
1996
(
SBREFA),
generally
provides
that
before
a
rule
may
take
effect,
the
agency
promulgating
the
rule
must
submit
a
rule
report,
which
includes
a
copy
of
the
rule,
to
each
House
of
the
Congress
and
to
the
Comptroller
General
of
the
United
States.
EPA
will
submit
a
report
containing
this
rule
and
other
required
information
to
the
U.
S.
Senate,
the
U.
S.
House
of
Representatives,
and
the
Comptroller
General
of
the
United
States
prior
to
publication
of
the
rule
in
the
Federal
Register.
This
rule
is
not
a
``
major
rule''
as
defined
by
5
U.
S.
C.
804(
2).

List
of
Subjects
Environmental
protection,
Pesticides,
Tribes.

Dated:
January
30,
2003.
Stephen
L.
Johnson,
Assistant
Administrator,
Office
of
Prevention,
Pesticides
and
Toxic
Substances.
[
FR
Doc.
03
 
3582
Filed
2
 
13
 
03;
8:
45
am]

BILLING
CODE
6560
 
50
 
S
ENVIRONMENTAL
PROTECTION
AGENCY
[
OPP
 
2002
 
0341;
FRL
 
7289
 
5]

Boscalid;
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
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Federal
Register
/
Vol.
68,
No.
31
/
Friday,
February
14,
2003
/
Notices
regulations
for
residues
of
boscalid
in
or
on
various
food
commodities.
DATES:
Comments,
identified
by
docket
ID
number
OPP
 
2002
 
0341,
must
be
received
on
or
before
March
17,
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:
Richard
Keigwin,
Registration
Division
(
7505C),
Office
of
Pesticide
Programs,
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460
 
0001;
telephone
number:
(
703)
305
 
7618;
e­
mail
address:
keigwin.
richard@
epa.
gov.

SUPPLEMENTARY
INFORMATION:

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

You
may
be
potentially
affected
by
this
action
if
you
are
an
agricultural
producer,
food
manufacturer,
or
pesticide
manufacturer.
Potentially
affected
entities
may
include,
but
are
not
limited
to:
 
Crop
production
(
NAICS
111)
 
Animal
production
(
NAICS
112)
 
Food
manufacturing
(
NAICS
311)
 
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
identification
(
ID)
number
OPP
 
2002
 
0341.
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,

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Federal
Register
/
Vol.
68,
No.
31
/
Friday,
February
14,
2003
/
Notices
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
 
0341.
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
 
0341.
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
 
0341.
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
 
0341.
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
3,
2003.
Debra
Edwards,
Acting
Director,
Registration
Division,
Office
of
Pesticide
Programs.

Summary
of
a
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.

BASF
Corporation
PP
1F6313
EPA
has
received
a
pesticide
petition
(
1F6313)
from
BASF
Corporation,
P.
O.
Box
13528,
Research
Triangle
Park,
NC
27709
proposing,
pursuant
to
section
408(
d)
of
the
Federal
Food,
Drug,
and
Cosmetic
Act
(
FFDCA),
21
U.
S.
C.
346a(
d),
to
amend
40
CFR
part
180
by
establishing
a
tolerance
for
residues
of
boscalid,
3­
pyridinecarboxamide,
2­
chloro­
N­(
4'­
chloro(
1,1'­
biphenyl)­
2­
yl)]]
in
or
on
the
following
primary
raw
agricultural
commodities
and
processed
commodities:
Root
vegetables
(
crop
group
1­
B)
1.0
parts
per
million
(
ppm),
tuberous
and
corm
vegetables
(
crop
group
1­
C)
0.05
ppm,
bulb
vegetables
(
crop
group
3)
3.0
ppm,
leafy
vegetables
(
crop
group
4)
11.0
ppm,
head
and
stem
brassica
(
sub
crop
group
5­
A)
3.0
ppm,
legume
vegetables
(
crop
group
6)
2.2
ppm,
fruiting
vegetables
(
crop
group
8)
1.0
ppm,
cucurbit
vegetables
(
crop
group
9)
1.5
ppm,
stonefruit
(
crop
group
12)
1.7
ppm,
berries
(
crop
group
13)
3.5
ppm,
tree
nuts
(
crop
group
14)
0.25
ppm,
almond
hulls
3.0
ppm,
pistachios
0.65
ppm,
mint
30.0
ppm,
grapes
3.5
ppm,
raisins
8.5
ppm,
strawberries
1.2
ppm,
peanut
0.05
ppm,
peanut
meal
0.15
ppm,
peanut
oil
0.15
ppm,
canola
3.5
ppm,
sunflower
seed
3.5
ppm.
BASF
Corporation
also
proposes
to
amend
40
CFR
part
180
by
establishing
tolerances
for
residues
of
3­
pyridinecarboxamide,
2­
chloro­
N­(
4'­

VerDate
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19:
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2003
Jkt
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00000
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Federal
Register
/
Vol.
68,
No.
31
/
Friday,
February
14,
2003
/
Notices
chloro(
1,1'­
biphenyl)­
2­
yl)
in
or
on
the
following
raw
agricultural
and
processed
commodities
of
rotational
crops:
Beet
root
1.0
ppm,
root
vegetables
(
crop
group
1­
B)
1.0
ppm,
leaves
of
root
and
tuber
vegetables
(
crop
group
2)
1.0
ppm,
head
and
stem
brassica
(
sub
crop
group
5­
A)
3.0
ppm,
leafy
brassica
greens
(
sub
crop
group
5­
B)
18.0
ppm,
legume
vegetables
­
peas
(
crop
group
6)
2.2
ppm,
foliage
of
legume
vegetables
(
crop
group
7):
forage
1.5
ppm,
hay
2.0
ppm,
vines
0.05
ppm,
cucurbit
vegetables
(
crop
group
9)
1.5
ppm,
cereal
grains
(
crop
group
15)
0.20
ppm,
forage
fodder
and
straw
of
cereal
grains
(
crop
group
16)
forage
2.0
ppm,
straw
3.0
ppm,
fodder
1.5
ppm,
grass
forage
fodder
and
hay
(
crop
group
17)
forage
2.0
ppm,
hay
8.0
ppm,
straw
0.3
ppm,
seed
0.2
ppm,
non­
grass
animal
feeds
(
crop
group
18)
forage
1.0
ppm,
hay
2.0
ppm,
seed
0.2
ppm,
mint
30.0
ppm,
cotton
seed
0.05
ppm,
cotton
gin
byproducts
0.3
ppm,
soybean
seed
0.1
ppm,
soybean
hulls
0.2
ppm,
flax
seed
3.5
ppm,
sunflower
seed
3.5
ppm,
and
rice
hulls
0.5
ppm.
BASF
Corporation
is
also
proposing
to
amend
40
CFR
part
180
by
establishing
tolerances
for
the
combined
residues
of
3­
pyridinecarboxamide,
2­
chloro­
N­(
4'­
chloro
(
1,1'­
biphenyl)­
2­
yl
and
its
metabolite
2­
chloro­
N­(
4'
chloro­
5­
hydroxy­
biphenyl­
2­
yl)
nicotinamide
expressed
in
parent
equivalents
in
the
following
animal
commodities:
Cow
milk
0.10
ppm,
cow
muscle
0.10
ppm,
cow
fat
0.30
ppm,
cow
meat
by­
products
0.35
ppm,
eggs
0.02
ppm,
poultry
muscle
0.05
ppm,
poultry
fat
0.05
ppm,
and
poultry
meat
by­
products
0.05
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.

A.
Residue
Chemistry
1.
Plant
metabolism.
Nature
of
the
residue
studies
(
OPPTS
860.1300)
were
conducted
in
grapes,
lettuce,
and
beans
as
representative
crops
in
order
to
characterize
the
fate
of
boscalid,
also
known
as
BAS
510
F,
in
all
crop
matrices.
In
all
three
crops,
the
BAS
510
F
Residues
of
Concern
(
ROC)
were
characterized
as
parent
(
BAS
510
F).
A
confined
rotational
crop
study
also
determined
that
parent
was
the
residue
of
concern
in
the
representative
crops
of
radish,
lettuce,
and
wheat.
2.
Analytical
method.
In
plants
the
parent
residue
is
extracted
using
an
aqueous
organic
solvent
mixture
followed
by
liquid/
liquid
partitioning
and
a
column
cleanup.
Quantitation
is
by
gas
chromatography/
mass
spectrometry
(
GC/
MS).
In
livestock
the
residues
are
extracted
with
methanol.
The
extract
is
treated
with
enzymes
in
order
to
release
the
conjugated
glucuronic
acid
metabolite.
The
residues
are
then
isolated
by
liquid/
liquid
partition
followed
by
column
chromatography.
The
hydroxylated
metabolite
is
acetylated
followed
by
a
column
cleanup.
The
parent
and
acetylated
metabolite
are
quantitated
by
gas
chromatography/
electron
capture
detection
(
GC/
ECD).
3.
Magnitude
of
residues.
Field
trials
were
carried
out
in
order
to
determine
the
magnitude
of
the
residue
in
the
following
crops:
Almonds,
beans
(
dry
and
succulent),
edible
peas
(
dry
and
succulent),
canola,
carrot,
cucurbits,
grape,
lettuce,
leafy
vegetables
(
brassica
and
non­
brassica),
onion
(
dry
bulb
and
green),
peanut,
pecan,
pepper
(
bell
and
chili),
pistachio,
potato,
berries
(
crop
group),
stonefruit
(
cherries,
peaches,
plums),
strawberry,
tomato,
mint,
and
sunflower.
Field
trials
were
conducted
in
the
United
States
and
Canada
in
the
required
regions.
Field
trials
were
carried
out
using
the
maximum
label
rate,
the
maximum
number
of
applications,
and
the
minimum
preharvest
interval
for
each
crop
or
crop
group.
In
addition,
processing
studies
were
conducted
on
the
following
crops
to
determine
concentration
factors
during
normal
processing
of
the
raw
agricultural
commodity
into
the
processed
commodities:
Canola,
grape,
peanut,
plum,
tomato,
sunflower,
and
mint.
Magnitude
of
the
residue
studies
were
also
carried
out
in
dairy
cows
and
hens.
Tier
III
field
rotational
crop
studies
were
conducted
to
support
rotational
crop
tolerances
for
beet
roots,
beet
tops,
cotton,
foliage
of
legume
vegetables,
soybeans,
cereals,
grass
and
non­
grass
animal
feeds.
Processing
studies
were
conducted
on
soybeans
and
rice
to
determine
concentration
factors.

B.
Toxicological
Profile
1.
Acute
toxicity.
Based
on
available
acute
toxicity
data
BAS
510
F
and
its
formulated
products
do
not
pose
acute
toxicity
risks.
The
acute
toxicity
studies
place
technical
BAS
510
F
in
toxicity
category
IV
for
acute
oral;
category
III
for
acute
dermal
and
category
IV
for
acute
inhalation.
BAS
510
F
is
category
IV
for
both
eye
and
skin
irritation,
and
it
is
not
a
dermal
sensitizer.
Two
formulated
end
use
products
are
proposed,
a
Water
Dispersible
Granule
(
WG)
termed
BAS
510
02
F
containing
70%
BAS
510
F
and
a
Water
Dispersible
Granule
(
WG)
termed
BAS
516
02
F
containing
a
2:
1
mixture
of
BAS
510
F
and
BAS
500
F.
BAS
510
02
F
has
an
acute
oral
toxicity
category
of
III,
acute
dermal
of
III,
acute
inhalation
of
IV,
eye
irritation
of
III,
skin
irritation
of
IV,
and
is
not
a
dermal
sensitizer.
BAS
516
02
F
has
an
acute
oral
toxicity
category
of
III,
acute
dermal
of
III,
acute
inhalation
of
IV,
eye
irritation
of
III,
skin
irritation
of
IV,
and
is
not
a
dermal
sensitizer.
2.
Genotoxicity.
Ames
Test
(
one
study;
point
mutation):
Negative;
In
Vitro
CHO/
HGPRT
Locus
Mammalian
Cell
Mutation
Assay
(
one
study;
point
mutation):
Negative;
In
Vitro
V79
Cell
Cytogenetic
Assay
(
one
study;
chromosome
damage):
Negative;
In
Vivo
Mouse
Micronucleus
(
one
study;
chromosome
damage):
Negative;
In
Vitro
Rat
Hepatocyte
(
one
study;
DNA
damage
and
repair):
Negative.
BAS
510
F
has
been
tested
in
a
total
of
five
genetic
toxicology
assays
consisting
of
in
vitro
and
in
vivo
studies.
It
can
be
stated
that
BAS
510
F
did
not
show
any
mutagenic,
clastogenic
or
other
genotoxic
activity
when
tested
under
the
conditions
of
the
studies
mentioned
above.
Therefore,
BAS
510
F
does
not
pose
a
genotoxic
hazard
to
humans.
3.
Reproductive
and
developmental
toxicity.
The
reproductive
and
developmental
toxicity
of
BAS
510
F
was
investigated
in
a
2
 
generation
rat
reproduction
study
as
well
as
in
rat
and
rabbit
teratology
studies.
There
were
no
adverse
effects
on
reproduction
in
the
2
 
generation
study
at
any
dose
tested.
Pup
effects
were
observed,
with
parental
toxicity,
at
the
highest
dose
tested
only.
In
both
parental
generations,
reduced
food
consumption
and
reduced
body
weight
(
bwt)
gain
were
observed
at
10,000
ppm.
Both
absolute
and
relative
liver
weights
were
increased
21%
in
F1
generation
parental
females
at
the
high
dose
of
10,000
ppm
only.
Hepatocellular
centrilobular
hypertrophy
(
usually
slight)
was
observed
in
many
animals
of
both
sexes
in
both
the
F0
and
F1
generations
at
1,000
ppm,
and
in
all
animals
of
both
sexes
at
10,000
ppm.
Additionally,
some
of
the
parental
male
rats
at
10,000
ppm,
in
both
generations,
displayed
centrilobular
liver
cell
degeneration.
Developmental
toxicity
was
seen
at
1,000
ppm
in
the
form
of
decreased
pup
weights
in
the
F2
males,
and
at
10,000
ppm
in
the
form
of
decreased
pup
weight
for
both
males
and
females
of
both
the
F1
and
F2
generations.
The
parental
systemic
and
developmental
toxicity
no
observed
adverse
effect
levels
(
NOAEL)
are
both
100
ppm
(
12
milligrams/
kilogram/
day
(
mg/
kg/
day).

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Notices
No
teratogenic
effects
were
noted
in
either
the
rat
or
rabbit
developmental
studies.
In
the
rat
study,
evidence
of
maternal
or
developmental
toxicity
was
not
observed
at
any
dose
(
highest
dose
tested
of
1,000
mg/
kg/
day).
Neither
a
maternal
nor
developmental
lowest
observed
adverse
effect
level
(
LOAEL)
were
found
since
the
highest
dose
tested
was
the
NOAEL
in
both
studies.
In
the
rabbit
teratology
study,
maternal
toxicity
observed
at
the
mid
dose
of
300
mg/
kg
bwt
consisted
of
discolored/
reduced
feces
in
one
dam
and
an
abortion
in
one
dam.
This
finding
is
not
necessarily
indicative
of
a
definitive
test
substance
related
adverse
effect.
The
dam
which
displayed
the
fecal
alterations
and
abortion
also
displayed
decreased
body
weight
and
body
weight
gain
­
compared
to
the
group
mean
­
during
gestation.
These
decreases
occurred
even
prior
to
compound
administration.
Food
consumption
was
also
dramatically
decreased
in
this
dam
compared
to
the
other
animals
in
the
group.
Every
day
from
gestation
day
(
GD)
1
­
12,
this
dam
had
food
consumption
values,
which
were
less
than
half
the
mean
for
the
group
(
compound
administration
began
on
GD
7).
From
GD
13
to
26
(
when
the
animal
aborted
and
was
sacrificed)
this
dam
ate
essentially
nothing
(
food
consumption
during
this
time
period
was
 
1.5
grams/
day).
These
decreases
in
body
weight,
body
weight
gain,
and
food
consumption,
prior
to
compound
administration,
all
indicate
an
animal
in
poor
health
and
this
poor
state
of
health,
rather
than
compound
exposure,
was
likely
the
reason
for
the
fecal
alterations
and
abortion.
At
the
high
dose
of
1,000
mg/
kg
bwt
a
maternal
body
weight
gain
decrease
compared
to
controls
of
81%
was
observed
during
the
treatment
period.
Reduced
food
consumption,
reduced
body
weight
and
abortions
in
three
dams,
were
also
seen
at
1,000
mg/
kg/
day.
Evidence
of
developmental
toxicity
was
not
seen
at
any
dose
tested.
Developmental
neurotoxicity
(
DNT)
was
not
observed
at
any
dose
in
the
developmental
neurotoxicity
study.
No
maternal
toxic
effects
were
noted
at
any
dose
in
this
study.
No
developmental
toxicity
was
seen
at
the
low
dose
of
12
mg/
kg/
day
(
100
ppm).
Reduced
body
weights
and
body
weight
gains
were
seen
at
118
mg/
kg/
day
(
1,000
ppm)
during
postnatal
day
(
PND)
1
 
4.
Reduced
body
weights
and
body
weight
gains
were
seen
at
1,183
mg/
kg/
day
(
10,000
ppm)
as
well
as
decreased
absolute
pup
brain
weight
at
day
11
post
partum
(
p.
p.)
(
both
sexes)
and
decreased
brain
length
(
males
only)
at
day
11
p.
p.
The
reduced
pup
brain
weights
and
decreased
brain
length
go
hand­
in­
hand
and
both
are
due
to
the
decreased
pup
weights
seen
at
this
dose.
In
this
respect,
it
should
be
noted
that
pup
brain
weights
relative
to
body
weight
at
p.
p.
11
were
not
significantly
different
from
controls
at
this
dose.
Though
no
maternal
toxicity
was
seen
in
this
study,
other
studies
using
similar
doses
of
BAS
510
resulted
in
maternal
toxicity.
A
dose
of
118
mg/
kg/
day
in
female
rats
of
the
same
strain
in
the
multi­
generation
study,
resulted
in
an
increased
incidence
of
hepatic
centrilobular
hypertrophy
a
parameter
which
could
not
have
been
detected
in
the
DNT
study
as
liver
histopathology
on
parental
animals
was
not
performed
in
the
DNT
study.
4.
Subchronic
toxicity.
The
subchronic
toxicity
of
BAS
510
F
was
investigated
in
90
 
day
feeding
studies
with
rats,
mice
and
dogs,
and
in
a
28
 
day
dermal
administration
study
in
rats.
A
90
 
day
neurotoxicity
study
in
rats
was
also
performed.
Generally,
mild
toxicity
was
observed.
At
high
dose
levels
(
doses
above
the
LOAELs)
in
feeding
studies,
all
three
species
displayed
alterations
in
various
clinical
chemistry
parameters.
These
clinical
chemistry
alterations
were
likely
secondary
to
general
toxicity.
Statistically
significant
increased
absolute
and
relative
thyroid
weights
were
observed
in
male
rats
only
at
doses
at
and
above
the
LOAEL.
Increased
absolute
and
relative
liver
weights
were
observed
in
both
sexes
at
doses
above
the
LOAEL
in
rats
and
dogs.
Increased
absolute
and
relative
liver
weights
were
seen
in
both
sexes
of
the
mouse
at
lower
doses.
However,
the
increases
in
liver
weights
at
these
lower
doses
in
the
mouse
were
not
deemed
to
be
compound
related
due
to
the
unusually
low
concurrent
control
liver
weight
values.
At
doses
above
the
LOAELs,
liver
weight
increases
were
supported
by
histopathology
alterations
in
the
rat
and
mouse,
but
not
in
the
dog.
Overall,
only
mild
toxicity
was
observed
in
oral
subchronic
testing.
In
the
28
 
day
repeat
dose
dermal
study,
no
systemic
effects
were
noted
up
to
the
highest
dose
tested
of
1,000
mg/
kg/
day.
In
a
90
 
day
rat
neurotoxicity
study,
there
was
no
mortality,
signs
of
clinical
toxicity,
adverse
effects
on
food
consumption
or
body
weight,
at
any
dose
level
in
either
sex.
No
signs
of
neurotoxicity
were
observed
during
clinical
observations,
functional
observation
batteries,
motor
activity
measurements
of
neuropathology.
Therefore,
there
were
no
selective
neurotoxic
effects.
Adverse
effects
were
not
seen
even
at
the
highest
dose
level
tested.
A
LOAEL
was
not
found
and
the
NOAEL
is
the
highest
tested
of
15,000
ppm
(
1,050
mg/
kg/
day
in
males;
1,272
mg/
kg/
day
in
females).
5.
Chronic
toxicity.
Based
on
review
of
the
available
data,
the
Reference
Dose
(
RfD)
for
BAS
510
F
will
be
based
on
a
24
 
month
feeding
study
in
rats
with
a
threshold
no
observed
effect
level
(
NOEL)
of
5
mg/
kg/
day.
Using
an
uncertainty
factor
of
100,
the
RfD
is
calculated
to
be
0.05
mg/
kg/
day.
The
following
are
summaries
of
chronic
toxicity
studies
submitted
to
EPA.
The
chronic
toxicity/
oncogenicity
studies
with
BAS
510
F
include
a
12
 
month
feeding
study
with
Beagle
dogs,
an
18
 
month
B63CF1
mouse
feeding
study,
a
24
 
month
Wistar
rat
chronic
feeding
study
and
a
24
 
month
Wistar
rat
oncogenicity
study.
At
the
highest
dose
tested
in
dogs,
effects
observed
consisted
primarily
of
increased
liver
and
thyroid
weights
and
some
serum
clinical
chemistry
changes.
The
NOAEL
was
800
ppm
(
21.8
mg/
kg
bwt
males;
22.1
mg/
kg
bwt
females).
Decreased
body
weights
were
seen
in
males
in
the
mouse
chronic
study
at
doses
of
400
ppm
and
above.
Decreased
female
body
weight
was
seen
at
doses
of
2,000
ppm
and
above.
The
target
organ
in
this
study
was
the
liver.
In
both
the
rat
chronic
and
oncogenicity
studies,
the
highest
dose
tested
of
15,000
ppm
exceeded
a
maximum
tolerated
dose
(
MTD)
and
was
discontinued
after
17
months.
Effects
observed
at
the
next
highest
dose
of
2,500
ppm
primarily
centered
around
the
thyroid
and
liver.
Overall,
mild
toxicity
was
observed
with
chronic
exposure
to
BAS
510
F.
No
evidence
of
treatment­
induced
oncogenicity
was
observed
in
the
mouse
or
dog
studies.
A
slight
increase
in
thyroid
follicular
cell
adenomas
was
seen
in
both
sexes
at
the
high
dose
when
the
data
from
both
rat
bioassays
are
combined.
A
mode
of
action
(
MOA)
for
the
thyroid
follicular
cell
adenomas
has
been
proposed.
This
MOA
is
based
on
the
EPA
publication
``
Assessment
of
Thyroid
Follicular
Cell
Tumors,''
March
1998,
EPA/
630/
R­
97/
002.
This
document
describes
the
criteria,
which
must
be
met
in
order
for
a
compound
to
be
considered
under
the
MOA
described
in
that
publication.
BASF
Corporation
believes
that
BAS
510
F
has
met
the
cited
criteria.
Threshold
effects.
Based
on
a
review
of
the
available
chronic
toxicity
data,
BASF
believes
EPA
will
establish
the
Reference
Dose
(
RfD)
for
BAS
510
F
at
0.05
mg/
kg/
day.
This
RfD
for
BAS
510
F
is
based
on
the
2
 
year
chronic
and
2
 
year
oncogenicity
studies
in
rats
with
a
threshold
average
NOAEL
of
5
mg/
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14,
2003
/
Notices
day
for
males
and
females.
Using
an
uncertainty
factor
of
100,
the
RfD
is
calculated
to
be
0.05
mg/
kg/
day.
Based
on
the
acute
toxicity
data,
BASF
believes
that
BAS
510
F
does
not
pose
any
acute
dietary
risks.
BAS
510
F
was
shown
to
be
noncarcinogenic
in
mice
and
dogs.
There
was
a
slight
increase
in
thyroid
follicular
cell
adenomas
at
the
high
dose
in
both
sexes
in
the
rat.
A
thresholdbased
mode
of
action
for
these
tumors
based
on
the
EPA
publication
``
Assessment
of
Thyroid
Follicular
Cell
Tumors''
(
EPA/
630/
R­
97/
002,
March,
1998)
has
been
proposed.
BASF
believes
the
data
to
support
this
proposed
mode
of
action
are
strong,
and
that
the
thyroid
tumors
seen
in
the
rat
following
BAS
510
F
exposure
have
a
threshold.
In
addition,
a
battery
of
genotoxicity
studies
demonstrated
that
BAS
510
F
has
no
genotoxic
or
clastogenic
potential.
Therefore,
BASF
believes
that
the
threshold
approach
to
regulating
BAS
510
F
is
appropriate.
Also,
it
should
be
noted
that,
while
the
Agency
has
in
the
past
considered
tumors
of
this
type
to
be
potential
human
carcinogens,
the
European
Union
has
published
a
policy
which
considers
these
tumor
types,
when
they
occur
at
low
incidence
rates
in
the
rat,
to
not
be
relevant
to
man.
The
publication:
``
European
Commission,
European
Chemicals
Bureau,
ECBI/
49/
99
Add.
1
Rev.
2;
Draft
Summary
Record,
Commission
Group
of
Specialized
Experts
in
the
Fields
of
Carcinogenicity,
Mutagenicity
and
Reprotoxicity,
Meeting
at
Arona,
12
September
1999.''
Therefore,
BASF
believes
that
these
tumors
are
not
likely
relevant
to
humans
and,
if
these
tumors
are
to
be
considered
relevant
to
humans,
the
threshold
approach
to
cancer
risk
assessment
is
appropriate.
6.
Animal
metabolism.
In
the
rat,
the
predominant
route
of
excretion
of
BAS
510
F
is
fecal
with
urinary
excretion
being
minor.
The
half­
life
of
BAS
510
F
is
less
than
24
hours.
Saturation
of
absorption
appears
to
be
occurring
at
the
high
dose
level.
BAS
510
F
is
rapidly
and
intensively
metabolised
to
a
large
number
of
biotransformation
products.
The
hydroxylation
of
the
diphenyl
moiety
was
the
quantitatively
most
important
pathway.
Second
most
important
was
the
substitution
of
the
Cl
of
the
2­
chloropyridine
part
against
SH
by
conjugation
with
glutathione.
No
major
differences
were
observed
with
regard
to
label,
sex,
and
dose
level.
In
hens
and
goats
the
residues
of
concern
were
determined
to
be
parent,
the
hydroxylated
metabolite
M510F01
(
2­
chloro­
N­(
4'
chloro­
5­
hydroxy­
biphenyl­
2­
yl)
nicotinamide),
and
the
glucuronic
acid
of
the
metabolite
M510F02.
7.
Metabolite
toxicology.
No
additional
studies
were
required
for
metabolite
toxicology.
8.
Endocrine
disruption.
No
specific
tests
have
been
conducted
with
BAS
510
F
to
determine
whether
the
chemical
may
have
an
effect
in
humans
that
is
similar
to
an
effect
produced
by
a
naturally
occurring
estrogen
or
other
endocrine
effects.
However,
there
were
no
significant
findings
in
other
relevant
toxicity
studies
(
i.
e.,
subchronic
and
chronic
toxicity,
teratology
and
multigeneration
reproductive
studies)
which
would
suggest
that
BAS
510
F
produces
endocrine­
related
effects.

C.
Aggregate
Exposure
1.
Dietary
exposure
 
i.
Food.
A
chronic
dietary
exposure
analysis
was
conducted
for
BAS
510
F
including
crops
which
are
target
uses
as
well
as
inadvertent
residues
in
rotational
crops.
The
analysis
assumed
100%
of
the
crops
were
treated,
default
processing
factors
(
even
though
much
lower
experimentally­
derived
processing
factors
are
available),
and
used
the
tolerance
value
for
residues.
Even
with
these
worst­
case
assumptions,
it
was
determined
that
the
Theoretical
Maximum
Residue
Contribution
(
TMRC)
was
only
30.1%
of
the
RfD
dose
for
the
U.
S.
population
and
62.5%
for
children
1
 
6
years
(
the
highest
exposed
age­
related
subpopulation).
Based
on
the
toxicology
results,
an
acute
dietary
risk
assessment
for
BAS
510
F
is
most
likely
not
required,
but
if
so
only
for
children
1
 
6
years.
For
dietary
exposure
estimation,
100%
crop
treated
and
tolerance
values
for
residues
were
used.
The
resulting
acute
exposure
prediction
for
children
1
 
6
years
(
the
highest
exposed
age­
related
subpopulation)
resulted
in
an
acceptable
8.8%
of
the
acute
reference
dose
at
the
95th
percentile.
If
a
more
realistic
scenario
were
used
assuming
percent
crop
treated
and
the
range
of
residues,
a
much
lower
exposure
would
be
obtained.
ii.
Drinking
water.
Estimates
of
ground
water
and
surface
water
levels
were
determined
using
Screening
Concentrations
in
Ground
Water
(
SCIGROW
and
First
Index
Reservoir
Screening
Tools
(
FIRST)
models,
respectively.
Using
SCI­
GROW
to
estimate
chronic
exposure
to
BAS
510
F
from
drinking
water,
drinking
water
consumption
utilizes
0.15%
of
the
RfD
for
the
U.
S.
population
and
0.044%
for
children
ages
1
 
6.
Using
FIRST
to
estimate
chronic
exposure
to
BAS
510
F
from
drinking
water,
drinking
water
consumption
utilizes
0.08%
of
the
RfD
for
the
U.
S.
population
and
0.24%
of
the
RfD
for
children
ages
1
 
6.
2.
Non­
dietary
exposure.
BAS
510
F
is
not
currently
planned
for
residential
uses.
Thus,
residential
exposure
is
not
aggregated
into
the
risk
assessment.

D.
Cumulative
Effects
Section
408(
b)(
2)(
D)(
v)
requires
that,
when
considering
whether
to
establish,
modify,
or
revoke
a
tolerance,
the
Agency
consider
``
available
information''
concerning
the
cumulative
effects
of
a
particular
pesticide's
residues
and
``
other
substances
that
have
a
common
mechanism
of
toxicity.''
BAS
510
F
is
a
foliar
fungicide
chemically
belonging
to
the
carboxin
class
of
fungicides.
BAS
510
F
acts
in
the
fungal
cell
by
inhibiting
of
mitochondrial
respiration
through
inhibition
of
the
succinate­
ubiquinone
oxidase
reductase
system
in
Complex
II
of
the
mitochondrial
electron
transport
chain.
BAS
510
F
shares
this
mode
of
action
with
only
one
other
currently
registered
U.
S.
pesticide
carboxin.
EPA
is
currently
developing
methodology
to
perform
cumulative
risk
assessments.
At
this
time,
there
is
no
available
data
to
determine
whether
BAS
510
F
has
a
common
mechanism
of
toxicity
with
other
substances
or
how
to
include
this
pesticide
in
a
cumulative
risk
assessment.
Unlike
other
pesticides
for
which
EPA
has
followed
a
cumulative
risk
approach
based
on
a
common
mechanism
of
toxicity,
BAS
510
F
does
not
appear
to
produce
a
toxic
metabolite
produced
by
other
substances.

E.
Safety
Determination
1.
U.
S.
population.
Using
the
conservative
exposure
assumptions
described
above
and
based
on
the
completeness
and
the
reliability
of
the
toxicity
data,
BASF
has
estimated
that
aggregate
exposure
to
BAS
510
F
will
utilize
30.2%
of
the
RfD
for
the
US
population.
For
the
highest
exposed
agerelated
subpopulation
(
children
1­
6
years),
the
maximum
aggregate
exposure
is
predicted
to
be
62.8%
of
the
reference
dose.
BASF
concludes
that
there
is
a
reasonable
certainty
that
no
harm
will
result
from
the
aggregate
exposure
to
residues
of
BAS
510
F,
including
anticipated
dietary
and
drinking
water
exposures
and
non­
occupational
exposures.
2.
Developmental
toxicity
in
the
rat.
A
developmental
study
was
conducted
via
oral
gavage
in
rats
with
dosages
of
0,
100,
300,
and
1,000
mg/
kg
bwt/
day
with
a
maternal
and
developmental
no
observed
adverse
effect
level
(
NOAEL)
of
1,000
mg/
kg.
No
evidence
of
developmental
toxicity
was
observed
up
to
the
highest
dose
tested.
3.
Developmental
toxicity
in
the
rabbit.
A
developmental
study
was
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Federal
Register
/
Vol.
68,
No.
31
/
Friday,
February
14,
2003
/
Notices
conducted
via
oral
gavage
in
rabbits
with
dosages
of
0,
100,
300,
and
1,000
mg/
kg
bwt/
day.
The
NOAEL
for
maternal
toxicity
was
100
mg/
kg
bwt/
day
and
was
1,000
mg/
kg/
day
for
developmental
toxicity.
As
noted
above
this
NOAEL
is
based
on
fecal
alterations
and
an
abortion
in
a
single
dam
at
the
next
highest
dose
of
300
mg/
kg/
day.
The
dam
which
displayed
the
fecal
alterations
and
abortion
also
displayed
decreased
body
weight,
body
weight
gain
and
food
consumption
­
compared
to
the
group
mean
­
during
gestation.
These
decreases
occurred
even
prior
to
compound
administration.
These
decreases
in
body
weight,
body
weight
gain,
and
food
consumption,
prior
to
compound
administration,
all
indicate
an
animal
in
poor
health
and
this
poor
state
of
health,
rather
than
compound
exposure,
was
likely
the
reason
for
the
fecal
alterations
and
abortion.
No
teratogenic
effects
were
observed
at
any
dose
level.
4.
Reproductive
toxicity.
A
2
 
generation
reproduction
study
in
rats
was
conducted
with
dosages
of
0,
12,
118,
and
1,183
mg/
kg
bwt/
day.
No
impairment
of
reproductive
function
was
noted
at
any
dose.
The
parental
and
developmental
NOAEL
are
both
12
mg/
kg/
day.
Mild
effects
in
both
the
parents
and
pups
were
noted
at
118
mg/
kg/
day
and
consisted
of
an
increased
incidence
of
hepatic
centrilobular
hypertrophy
in
parents
and,
in
the
pups,
slightly
decreased
body
weight
and
body
weight
gain
(
7%)
in
F2
generation
only,
and
only
in
males.
At
1,183
mg/
kg/
day
paternal
effects
included
decreased
body
weights
and
food
consumption,
increased
liver
weights
and
increased
incidence
of
hepatic
centrilobular
hypertrophy
and
degeneration.
Pup
effects
at
this
dose
were
an
increase
in
pup
mortality
in
the
F2
only
and
a
decreased
body
weight
in
F1
and
F2.
5.
Reference
dose.
In
all
reproductive
studies,
the
NOAELs
for
developmental
effects
were
either
equal
to
or
higher
than
those
for
the
parents.
Therefore,
BAS
510
F
shows
no
selective
toxicity
for
the
young.
In
addition,
there
were
no
direct
neurotoxicity
effects
noted
in
either
the
acute
or
subchronic
neurotoxicity
studies.
Based
on
these
results,
no
additional
safety
factors
to
protect
children
are
warranted.
Since
the
reproductive
studies
NOAELs
are
higher
than
the
RfD
calculated
from
the
chronic
rat
study,
BASF
believes
the
RfD
of
0.05
mg/
kg/
day
is
also
appropriate
to
measure
safety
for
infants
and
children.
Therefore,
the
chronic
population
adjusted
dose
is
also
0.05
mg/
kg
bwt/
day.
F.
International
Tolerances
A
maximum
residue
level
has
not
been
established
for
BAS
510
F
in
any
crop
by
the
Codex
Alimentarius
Commission.

[
FR
Doc.
03
 
3694
Filed
2
 
13
 
03;
8:
45
am]

BILLING
CODE
6560
 
50
 
S
ENVIRONMENTAL
PROTECTION
AGENCY
[
OPP
 
2003
 
0007;
FRL
 
7289
 
1]

Pyrimethanil;
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
pyrimethanil
in
or
on
various
food
commodities.
DATES:
Comments,
identified
by
docket
ID
number
OPP
 
2002
 
0007,
must
be
received
on
or
before
March
17,
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:
Mary
Waller,
Registration
Division
(
7505C),
Office
of
Pesticide
Programs,
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460
 
0001;
telephone
number:
(
703)
308
 
9354;
e­
mail
address:
waller.
mary@
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:
 
Crop
production
(
NAICS
111)
 
Animal
production
(
NAICS
112)
 
Food
manufacturing
(
NAICS
311)
 
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
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
identification
(
ID)
number
OPP
 
2003
 
0007.
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
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