Document ID: EPA-HQ-OPP-2003-0008-0001
Agency: epa
Document Type: Notice
Title: Vinclozolin; Notice of Filing a Pesticide Petition To Establish a Tolerance for a Certain Pesticide Chemical in or on Food
Posted Date: 2003-03-26T05:00Z

14628
Federal
Register
/
Vol.
68,
No.
58
/
Wednesday,
March
26,
2003
/
Notices
Department
of
Agriculture,
the
Oregon
Department
of
Agriculture,
and
the
Washington
State
Department
of
Agriculture
have
requested
the
Administrator
issue
specific
exemptions
for
the
use
of
quinoxyfen
on
hops
to
control
powdery
mildew.
Information
in
accordance
with
40
CFR
part
166
was
submitted
as
part
of
this
request.
As
part
of
this
request,
the
Applicants
assert
that
currently
registered
products
and
non­
chemical
control
measures
do
not
provide
adequate
season
long
control
of
powdery
mildew
on
susceptible
hops
varieties.
Powdery
mildew
(
S.
macularis)
is
a
serious
hop
disease
in
many
hop
growing
areas
throughout
the
world.
During
the
early
part
of
this
century,
a
commercial
hop
production
industry
in
the
State
of
New
York
was
devastated
due
to
what
is
believed
to
have
been
an
uncontrolled
outbreak
of
powdery
mildew.
Before
June
of
1997,
this
disease
had
not
been
observed
in
the
Pacific
Northwest.
Quinoxyfen
has
been
shown
to
be
an
effective
fungicide
against
hop
powdery
mildew
over
the
past
4
years
of
testing.
Quinoxyfen
has
not
shown
any
plant
growth
regulatory
effects
or
adverse
impact
to
cone
size.
Additionally,
quinoxyfen
is
a
quinoline
fungicide,
which
will
provide
growers
with
a
new
mode
of
action
to
control
powdery
mildew.
The
U.
S.
is
the
second
largest
producer
of
hops
in
the
world.
The
States
estimate
that
there
will
be
an
8%
to
30%
loss
of
gross
revenues
without
the
use
of
quinoxyfen.
The
Applicants
propose
to
apply
no
more
than
6
to
8
fluid
ounces
of
formulated
product,
containing
22.58%
quinoxyfen
(
0.098
to
0.13
pound/
active
ingredient)
per
acre
per
application.
No
more
than
four
applications
per
acre
per
year
will
be
made.
A
total
of
19,500
acres
of
hops
may
be
treated;
up
to
3,000
acres
of
hops
in
Idaho,
3,500
acres
of
hops
in
Oregon,
and
13,000
acres
of
hops
in
Washington
State.
Applications
will
be
made
from
July
1,
2003,
through
September
15,
2003.
Based
on
the
maximum
application
rate
and
a
total
of
four
applications
per
acre,
up
to
10,140
pounds
of
quinoxyfen
could
be
applied.
This
notice
does
not
constitute
a
decision
by
EPA
on
the
application
itself.
The
regulations
governing
section
18
of
FIFRA
require
publication
of
a
notice
of
receipt
of
an
application
for
a
specific
exemption
proposing
``
use
of
a
new
chemical
(
i.
e.,
an
active
ingredient)
which
has
not
been
registered
by
EPA.''
The
Agency,
will
review
and
consider
all
comments
received
during
the
comment
period
in
determining
whether
to
issue
the
specific
exemptions
requested
by
the
Idaho
Department
of
Agriculture,
the
Oregon
Department
of
Agriculture,
and
the
Washington
State
Department
of
Agriculture.

List
of
Subjects
Environmental
protection,
Pesticides
and
pests.

Dated:
March
13,
2003.
Debra
Edwards,
Acting
Director,
Registration
Division,
Office
of
Pesticide
Programs.

[
FR
Doc.
03
 
6947
Filed
3
 
25
 
03;
8:
45
am]

BILLING
CODE
6560
 
50
 
S
ENVIRONMENTAL
PROTECTION
AGENCY
[
OPP
 
2003
 
0008;
FRL
 
7289
 
2]

Vinclozolin;
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
to
make
permanent
the
tolerances
for
residues,
and
to
extend
existing
tolerances
for
residues
of
a
certain
pesticide
chemical
in
or
on
various
food
commodities.
DATES:
Comments,
identified
by
docket
ID
number
OPP
 
2003
 
0008,
must
be
received
on
or
before
April
25,
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
L.
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
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)
 
Antimicrobial
pesticides
(
NAICS
32561)
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
 
2003
 
0008.
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.

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14629
Federal
Register
/
Vol.
68,
No.
58
/
Wednesday,
March
26,
2003
/
Notices
Certain
types
of
information
will
not
be
placed
in
the
EPA
Dockets.
Information
claimed
as
CBI
and
other
information
whose
disclosure
is
restricted
by
statute,
which
is
not
included
in
the
official
public
docket,
will
not
be
available
for
public
viewing
in
EPA's
electronic
public
docket.
EPA's
policy
is
that
copyrighted
material
will
not
be
placed
in
EPA's
electronic
public
docket
but
will
be
available
only
in
printed,
paper
form
in
the
official
public
docket.
To
the
extent
feasible,
publicly
available
docket
materials
will
be
made
available
in
EPA's
electronic
public
docket.
When
a
document
is
selected
from
the
index
list
in
EPA
Dockets,
the
system
will
identify
whether
the
document
is
available
for
viewing
in
EPA's
electronic
public
docket.
Although
not
all
docket
materials
may
be
available
electronically,
you
may
still
access
any
of
the
publicly
available
docket
materials
through
the
docket
facility
identified
in
Unit
I.
B.
EPA
intends
to
work
towards
providing
electronic
access
to
all
of
the
publicly
available
docket
materials
through
EPA's
electronic
public
docket.
For
public
commenters,
it
is
important
to
note
that
EPA's
policy
is
that
public
comments,
whether
submitted
electronically
or
in
paper,
will
be
made
available
for
public
viewing
in
EPA's
electronic
public
docket
as
EPA
receives
them
and
without
change,
unless
the
comment
contains
copyrighted
material,
CBI,
or
other
information
whose
disclosure
is
restricted
by
statute.
When
EPA
identifies
a
comment
containing
copyrighted
material,
EPA
will
provide
a
reference
to
that
material
in
the
version
of
the
comment
that
is
placed
in
EPA's
electronic
public
docket.
The
entire
printed
comment,
including
the
copyrighted
material,
will
be
available
in
the
public
docket.
Public
comments
submitted
on
computer
disks
that
are
mailed
or
delivered
to
the
docket
will
be
transferred
to
EPA's
electronic
public
docket.
Public
comments
that
are
mailed
or
delivered
to
the
docket
will
be
scanned
and
placed
in
EPA's
electronic
public
docket.
Where
practical,
physical
objects
will
be
photographed,
and
the
photograph
will
be
placed
in
EPA's
electronic
public
docket
along
with
a
brief
description
written
by
the
docket
staff.

C.
How
and
To
Whom
Do
I
Submit
Comments?
You
may
submit
comments
electronically,
by
mail,
or
through
hand
delivery/
courier.
To
ensure
proper
receipt
by
EPA,
identify
the
appropriate
docket
ID
number
in
the
subject
line
on
the
first
page
of
your
comment.
Please
ensure
that
your
comments
are
submitted
within
the
specified
comment
period.
Comments
received
after
the
close
of
the
comment
period
will
be
marked
``
late.''
EPA
is
not
required
to
consider
these
late
comments.
If
you
wish
to
submit
CBI
or
information
that
is
otherwise
protected
by
statute,
please
follow
the
instructions
in
Unit
I.
D.
Do
not
use
EPA
Dockets
or
e­
mail
to
submit
CBI
or
information
protected
by
statute.
1.
Electronically.
If
you
submit
an
electronic
comment
as
prescribed
in
this
unit,
EPA
recommends
that
you
include
your
name,
mailing
address,
and
an
email
address
or
other
contact
information
in
the
body
of
your
comment.
Also
include
this
contact
information
on
the
outside
of
any
disk
or
CD
ROM
you
submit,
and
in
any
cover
letter
accompanying
the
disk
or
CD
ROM.
This
ensures
that
you
can
be
identified
as
the
submitter
of
the
comment
and
allows
EPA
to
contact
you
in
case
EPA
cannot
read
your
comment
due
to
technical
difficulties
or
needs
further
information
on
the
substance
of
your
comment.
EPA's
policy
is
that
EPA
will
not
edit
your
comment,
and
any
identifying
or
contact
information
provided
in
the
body
of
a
comment
will
be
included
as
part
of
the
comment
that
is
placed
in
the
official
public
docket,
and
made
available
in
EPA's
electronic
public
docket.
If
EPA
cannot
read
your
comment
due
to
technical
difficulties
and
cannot
contact
you
for
clarification,
EPA
may
not
be
able
to
consider
your
comment.
i.
EPA
Dockets.
Your
use
of
EPA's
electronic
public
docket
to
submit
comments
to
EPA
electronically
is
EPA's
preferred
method
for
receiving
comments.
Go
directly
to
EPA
Dockets
at
http://
www.
epa.
gov/
edocket,
and
follow
the
online
instructions
for
submitting
comments.
Once
in
the
system,
select
``
search,''
and
then
key
in
docket
ID
number
OPP
 
2003
 
0008.
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
 
0008.
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
 
0008.
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
 
0008.
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.

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Federal
Register
/
Vol.
68,
No.
58
/
Wednesday,
March
26,
2003
/
Notices
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:
March
18,
2003.
Debra
Edwards,
Acting
Director,
Registration
Division,
Office
of
Pesticide
Programs.

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

BASF
Corporation
PP
1F6278
EPA
has
received
a
pesticide
petition
(
1F6278)
from
BASF
Corporation,
Agricultural
Products,
P.
O.
Box
13528,
Research
Triangle
Park,
NC
27709
 
3528
proposing,
pursuant
to
section
408(
d)
of
the
FFDCA,
21
U.
S.
C.
346a(
d),
to
amend
40
CFR
part
180.380
by
making
permanent
the
tolerances
for
residues
of
vinclozolin,
3­(
3,5­
dichlorophenyl)­
5­
ethenyl­
5­
methyl­
2,4­
oxazolidinedione
and
its
metabolites
containing
the
3,5­
dichloroaniline
moiety
in
or
on
the
raw
agricultural
commodities
canola
at
1.0
parts
per
million
(
ppm);
eggs,
milk,
and
the
meat,
fat,
and
meat
byproducts
of
cattle,
goats,
hogs,
horses,
and
sheep
at
0.05
ppm;
and
in
the
meat,
fat,
and
meat
byproducts
of
poultry
at
0.1
ppm.
In
addition,
BASF
had
proposed
extending
the
existing
tolerance
on
succulent
beans
at
2.0
ppm
for
an
additional
2
years.
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
supports
granting
of
the
petition.
Additional
data
may
be
needed
before
EPA
rules
on
the
petition.

A.
Residue
Chemistry
1.
Plant
metabolism.
BASF
Corporation
notes
that
metabolism
in
plants
is
understood,
the
residues
of
concern
are
vinclozolin,
3­(
3,5­
dichlorophenyl)­
5­
methyl­
5­
vinyl­
1,3­
oxazolidine­
2,4­
dione)
and
metabolites
containing
the
3,5­
dichloroanaline
moiety.
2.
Analytical
method.
The
proposed
analytical
method
involves
extraction,
hydrolysis,
distillation,
partition,
and
deriviatization
followed
by
detection
of
residues
by
gas
chromatograph/
electron
capture
detector
(
gc/
ecd).
An
enforcement
method
has
been
published
in
FDA's
Pesticide
Analytical
Methods,
Volume
II
pg.
876
 
887.
3.
Magnitude
of
residues.
Data
previously
submitted
in
support
of
the
tolerances
in
canola,
succulent
beans
and
meat,
milk,
poultry,
and
eggs
have
been
reviewed
by
the
Agency
and
been
found
adequate
to
support
the
tolerances
requested.

B.
Toxicological
Profile
1.
Acute
toxicity.
On
July
18,
2000,
EPA
published
in
the
Federal
Register
(
65
FR
44453)
(
FRL
 
6594
 
8),
time
limited
tolerances
for
vinclozolin
in
canola,
succulent
beans
and
meat,
milk,
poultry
and
eggs.
The
toxicological
profile
as
reported
in
that
Federal
Register
is
repeated
in
this
Notice.
A
battery
of
acute
toxicity
studies
placed
technical
vinclozolin
in
toxicity
category
IV
for
acute
oral
toxicity
lethal
dose
(
LD)
50
of
>
10,000
milligrams/
kilograms
(
mg/
kg)),
and
acute
inhalation
toxicity
(
LC50
of
29.1
mg/
liter
(
L));
and
toxicity
category
III
for
acute
dermal
toxicity
(
LD50
of
>
5,000
mg/
kg).
Technical
vinclozolin
caused
minimal
eye
and
dermal
irritation
and
the
technical
material
is
positive
for
skin
sensitization.
2.
Genotoxicity.
Genotoxicity
testing
showed
no
evidence
of
mutagenic
activity.
(
For
details
see
the
July
18,
2000
Federal
Register
(
65
FR
44453)).
3.
Reproductive
and
developmental
toxicity
 
i.
In
four
developmental
toxicity
studies,
vinclozolin
was
given
orally
from
gestational
day
(
gd)
6
through
19
as
follows:
Study
4
 
dose
levels
of
0,
15,
50,
or
150
mg/
kg/
day;
study
5
 
dose
levels
of
0,
50,
100,
200
mg/
kg/
day;
study
6
 
dose
levels
of
0,
200,
400
mg/
kg/
day;
and
study
8
 
dose
levels
of
0,
600,
and
1,000
mg/
kg/
day.
At
the
gd
20,
the
fetuses
were
evaluated.
The
developmental
toxicity
no
observed
adverse
effect
level
(
NOAEL)
was
set
at
15
mg/
kg/
day
and
the
developmental
lowest
observed
adverse
effect
level
(
LOAEL)
was
50
mg/
kg/
day.
The
maternal
toxicity
LOAEL
was
<
600
mg/
kg/
day.
ii.
A
developmental
study
in
rats
via
dermal
exposure
for
6
hours/
day
on
intact
skin
with
dosages
of
0,
60,
180,
and
360
mg/
kg/
day
highest
dose
tested
(
HDT)
had
a
developmental
NOAEL
of
60
mg/
kg/
day
and
a
maternal
NOAEL
of
60
mg/
kg/
day.
iii.
A
developmental
study
in
rabbits
via
oral
gavage
resulted
in
dosages
of
0,
20,
80,
and
300
mg/
kg/
day
HDT
with
a
developmental
NOAEL
of
300
mg/
kg/
day
and
a
maternal
NOAEL
of
300
mg/
kg/
day.
iv.
A
second
developmental
study
in
rabbits
via
oral
gavage
resulted
in
dosages
of
0,
50,
200,
and
800
mg/
kg/
day
HDT
with
a
development
toxicity
NOAEL
of
200
mg/
kg/
day
and
a
maternal
toxicity
NOAEL
of
50
mg/
kg/
day.
A
two­
generation
rat
reproduction
study
(
consisting
of
two
studies:
Study
A
 
dose
levels
of
0,
2.0
and
4.1
mg/
kg/
day;
study
B
 
dose
levels
of
0,
4.9,
29,
100,
and
307
mg/
kg/
day)
with
a
reproductive
NOAEL
of
4.9
mg/
kg/
day
and
pup
effects
at
29
mg/
kg/
day;
and
with
a
parental
NOAEL
of
4.9
mg/
kg/
day.
(
For
a
detailed
discussion
of
the
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Vol.
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No.
58
/
Wednesday,
March
26,
2003
/
Notices
results
of
these
studies
see
the
Federal
Register
of
July
18,
2000
(
65
FR
44453)).
4.
Chronic
toxicity
 
i.
A
1
 
year
chronic
feeding
study
in
dogs
fed
dosages
of
0,
1.1,
2.4,
4.9,
and
48.7
mg/
kg/
day
with
a
NOAEL
of
2.4
mg/
kg/
day.
ii.
A
combination
of
2
chronic
feeding
studies
and
1
carcinogenicity
study
resulted
in
rats
being
fed
combined
dosages
of
0,
1.2,
2.4,
7.0,
23,
71,
143,
and
221
mg/
kg/
day
(
males)
and
0,
1.6,
3.1,
7.0,
23,
71,
180,
and
221
mg/
kg/
day
(
females)
with
a
NOAEL
of
1.2
mg/
kg/
day
(
males)
and
1.6
mg/
kg/
day
(
females).
An
increased
incidence
of
neoplasms
occurred
at
dose
levels
greater
than
the
maximum
tolerated
dose
(
MTD)
of
greater
than
or
equal
to
23
mg/
kg/
day
in
the
liver,
adrenal,
pituitary,
prostate
(
males),
uterus
(
females),
and
ovaries
(
females)
at
dose
levels
greater
than
or
equal
to
143
mg/
kg/
day.
In
the
testes
(
males),
Leydig
cell
adenomas
were
seen
at
the
MTD
for
dose
levels
greater
than
or
equal
to
23.0
mg/
kg/
day
due
to
the
anti­
androgenic
nature
of
vinclozolin.
5.
Carcinogenicity.
A
carcinogenicity
study
in
mice
fed
dosages
of
0,
2.1,
20.6,
432,
and
1,225
HDT
mg/
kg/
day
(
males)
and
0,
2.8,
28.5,
557,
and
1,411
(
HDT)
mg/
kg/
day
(
females)
with
a
NOAEL
of
20.6
mg/
kg/
day
(
males)
and
28.5
mg/
kg/
day.
An
increased
incidence
of
neoplasms
occurred
at
dose
levels
greater
than
the
maximum
tolerated
dose
(>
28.5
mg/
kg/
day)
in
the
liver
of
female
mice.
(
For
a
detailed
discussion
of
the
results
of
these
studies
see
the
Federal
Register
of
July
18,
2000
(
65
FR
44453)).

C.
Toxicological
Endpoints
EPA
determined
the
following
toxicological
endpoints
as
reported
in
the
Federal
Register
Notice
of
July
18,
2000.
That
reference
provides
a
complete
description
of
the
Agency's
rationale
for
the
values
assigned.
1.
Acute
toxicity.
EPA
selected
the
NOAEL
of
6
mg/
kg/
day.
The
population
subgroup
of
concern
is
females
(
13+)
because
the
endpoint
is
an
in
utero
effect
applicable
only
to
females
of
childbearing
age.
An
uncertainty
factor
(
UF)
of
100
was
used
to
account
for
interspecies
extrapolation
and
intraspecies
variation.
On
this
basis,
the
acute
reference
dose
(
aRfD)
is
0.06
mg/
kg/
day.
EPA
determined
that
a
10X
FQPA
safety
factor
is
applicable.
The
acute
population
adjusted
dose
(
aPAD)
is
0.006
mg/
kg/
day.
An
acute
dose
and
endpoint
were
not
identified
for
other
population
subgroups.
2.
Chronic
toxicity.
EPA
has
established
the
Reference
Dose
(
RfD)
for
vinclozolin
at
0.012
mg/
kg/
day.
This
RfD
is
based
on
a
NOAEL
of
1.2
mg/
kg/
day
from
the
combined
chronic
toxicity/
carcinogenicity
study
in
rats.
An
UF
of
100
was
used
to
account
for
interspecies
extrapolation
and
intraspecies
variation.
A
10X
FQPA
safety
factor
was
added
resulting
in
a
chronic
population
adjusted
dose
(
cPAD)
of
0.0012
mg/
kg/
day.
3.
Short­
and
intermediate­
term
toxicity.
For
short­
and
intermediateterm
dermal
and
inhalation
toxicity,
the
NOAEL
of
3
mg/
kg/
day
from
a
rat
developmental
toxicity
study
was
selected
for
the
population
subgroup
of
concern,
females
(
13+).
A
dermal
absorption
factor
of
25%
was
used
to
correct
for
route­
to­
route
extrapolation
(
oral
to
dermal
exposure)
and
a
default
inhalation
absorption
factor
of
100%
was
assumed
for
oral
to
inhalation
exposure.
The
margin
of
exposure
(
MOE)
for
females
(
13+),
infants
and
children
is
1,000X.
4.
Long­
term
dermal
and
inhalation
toxicity
(
cancer
and
non­
cancer).
For
chronic
non­
cancer
and
cancer
dermal
and
inhalation
toxicity,
EPA
selected
the
chronic
NOAEL
of
1.2
mg/
kg/
day
from
the
combined
rat
chronic
toxicity/
carcinogenicity
study.
The
Q1*
calculated
in
a
low­
dose
linear
extrapolation
is
2.9
x
10
 
1
(
mg/
kg/
day).
A
dermal
absorption
factor
of
25%
was
used
to
correct
for
route­
to­
route
extrapolation
(
oral
to
dermal
exposure)
and
a
default
inhalation
absorption
factor
of
100%
was
assumed
for
oral
to
inhalation
exposure.
The
cancer
assessment
includes
not
only
the
adult
U.
S.
population
but
also
infants
and
children
as
well.
5.
Carcinogenicity.
Vinclozolin
is
classified
as
a
Group
C
carcinogen
based
on
Leydig
(
interstitial
testicular)
cell
tumors
in
a
perinatal
rat
developmental
toxicity
study.
A
non­
linear
(
MOE)
approach
was
determined
to
be
appropriate
based
on
a
weight­
of­
theevidence
conclusion
that
tumor
induction
is
via
an
anti­
androgenic
mechanism.
Use
of
the
PAD
for
overall
anti­
androgenic
effects
(
0.0012
mg/
kg/
day)
is
also
protective
of
cancer
effects
because
it
is
protective
of
the
antiandrogenic
effects
that
are,
in
effect,
precursors
to
tumor
formation.
6.
Overall
anti­
androgenic
effects.
The
Agency
has
determined
that
use
of
the
most
sensitive
regulatory
toxicity
endpoint
and
the
highest
UF
would
be
protective
of
the
anti­
androgenic
effects
on
all
population
subgroups
caused
by
vinclozolin
including
developmental/
reproductive
effects
as
well
as
carcinogenic
effects.
In
the
case
of
vinclozolin,
the
most
sensitive
toxicity
endpoint/
dose
and
UF
are
derived
from
the
rat
oral
chronic/
carcinogenicity
study,
i.
e.,
the
NOAEL
of
1.2
mg/
kg/
day
and
an
UF
of
1,000.
The
PAD
of
0.0012
mg/
kg/
day
was
used
in
assessment
of
risks
resulting
from
the
anti­
androgenic
activity
of
vinclozolin.
7.
Endocrine
disruption.
A
series
of
mechanistic
studies
(
in
vivo
and
in
vitro)
were
conducted
to
define
the
antiandrogenic
properties
of
vinclozolin.
The
results
of
these
studies
showed
that
vinclozolin
elicits
the
anti­
androgenic
effects
by
binding
to
androgen
sensitive
organs.

D.
Aggregate
Exposure
For
a
detailed
discussion
of
the
results
of
these
exposure
calculations
see
the
Federal
Register
of
July
18,
2000
(
65
FR
44453).
1.
Dietary
exposure.
The
Agency
has
previously
calculated
exposures
and
risks
for
the
canola
green
beans,
meat,
milk,
poultry
and
eggs.
The
same
calculations
should
be
applied
to
reestablishing
these
tolerances.
i.
Food
 
a.
acute
exposure
and
risk.
Acute
dietary
risk
assessments
are
performed
for
a
food­
use
pesticide
if
a
toxicological
study
has
indicated
the
possibility
of
an
effect
of
concern
occurring
as
a
result
of
a
1
 
day
or
single
exposure.
The
Agency
concluded
that
acute
dietary
exposure
estimates
for
the
only
population
subgroup
of
concern,
females
(
13+),
that
``
The
very
conservatively
estimated
acute
dietary
risk
(
food
only)
does
not
exceed
the
Agency's
level
of
concern
(
LOC).''
b.
Chronic
exposure
and
risk.
The
chronic
dietary
exposure
estimates
expressed
as
a
percentage
of
the
cPAD
(
0.0012
mg/
kg/
day)
were
4%
for
the
U.
S.
population
and
7%
for
the
most
highly
exposed
population
subgroup,
children
(
1
 
6
years
old).
EPA
generally
has
no
concern
for
exposures
below
100%
of
the
cPAD
because
the
cPAD
represents
the
level
at
or
below
which
daily
aggregate
dietary
exposure
over
a
lifetime
will
not
pose
appreciable
risk
to
human
health.
Therefore,
the
chronic
dietary
risk
(
food
only)
does
not
exceed
the
Agency's
LOC.
ii.
For
cancer
and
anti­
androgenic
risk
assessment.
EPA
believes
that
vinclozolin
should
be
classified
as
a
Group
C
carcinogen.
However,
due
to
the
relationship
between
vinclozolin's
anti­
androgenic
properties
and
its
carcinogenic
effects,
the
Agency
believes
protecting
against
the
antiandrogenic
effects
would
also
be
protective
against
potential
carcinogenic
effects
to
all
population
subgroups
(
including
infants
and
children).
Accordingly,
the
cPAD
will
be
protective
against
potential
carcinogenic
effects
as
well
as
the
developmental/
reproductive
effects.
The
cPAD
already
incorporates
the
full,
additional
10x
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Notices
safety
factor
for
the
protection
of
infants
and
children
(
i.
e.,
it
is
derived
from
the
NOAEL
of
1.2
mg/
kg/
day
with
an
MOE
of
1,000
 
10x
for
intraspecies
extrapolation;
10x
for
interspecies
variation;
and
10x
for
FQPA).
Since
this
approach
(
using
the
cPAD)
would
be
more
protective
than
the
proposed
POD
for
cancer
risk
assessment
of
3
mg/
kg/
day,
and
includes
an
additional
10x
factor
for
the
protection
of
infants
and
children,
a
separate
non­
linear
risk
assessment
for
cancer
is
not
necessary.
Exposure
estimates
expressed
as
a
percentage
of
the
anti­
androgenic
PAD
(
0.0012
mg/
kg/
day)
were
4%
for
the
general
U.
S.
population
and
7%
for
the
most
highly
exposed
population
subgroup,
children
(
1
 
6
years
old).
In
addition,
as
a
point
of
comparison,
the
MOE
was
calculated
to
be
75,000
for
the
general
U.
S.
population
and
38,000
for
children
(
1
 
6
years
old).
2.
Drinking
water.
In
general,
available
monitoring
data
are
of
limited
use
because
metabolite
concentration
measurements
were
not
performed.
For
both
surface
water
and
ground
water,
the
sum
of
vinclozolin
and
its
principal
metabolites,
assumed
to
degrade
completely
to
3,5­
dichloroaniline
(
herein
after
referred
to
as
3,5­
DCA),
have
been
used
to
assess
the
cancer
risk
associated
with
3,5­
DCA
whereas
vinclozolin
per
se
has
been
used
for
the
vinclozolin
risk
assessments.
In
the
absence
of
reliable,
available
monitoring
data,
EPA
uses
models
to
calculate
the
estimated
environmental
concentrations
(
EECs)
of
pesticides
in
ground
water
and
surface
water.
However,
EPA
does
not
use
these
model
estimates
to
quantify
risk.
Currently,
EPA
uses
drinking
water
level
of
concerns
(
DWLOCs)
as
a
surrogate
to
capture
risk
associated
with
exposure
to
pesticides
in
drinking
water.
A
DWLOC
represents
the
concentration
of
a
pesticide
in
drinking
water
that
would
be
acceptable
as
an
upper
limit
in
light
of
total
aggregate
exposure
to
that
pesticide
from
food,
water,
and
residential
uses
(
if
any).
A
DWLOC
will
vary
depending
on
the
residue
level
in
foods,
the
toxicity
endpoint
and
the
drinking
water
consumption
patterns
and
body
weights
for
specific
population
subgroups.
The
calculated
DWLOC
is
compared
to
the
model
estimate
(
EEC),
and
if
the
model
estimates
are
below
the
DWLOC,
the
risks
are
not
considered
to
be
of
concern.
For
estimating
ground
water
concentrations
of
vinclozolin
and
3,5­
DCA,
EPA
used
the
Screening
Concentration
in
Ground
Water
(
SCIGROW
model.
Using
SCI­
GROW,
the
acute
and
chronic
ground
water
EEC
of
vinclozolin
per
se
is
0.53
parts
per
billion
(
ppb),
and
the
acute
and
chronic
ground
water
EEC
of
3,5­
DCA
is
2.65
ppb.
For
estimating
surface
water
concentrations
of
vinclozolin
and
3,5­
DCA,
EPA
used
tier
II
models,
Pesticide
Root
Zone
Model
(
PRZM)
3.12
and
Exposure
Analysis
Modeling
System
(
EXAMS)
2.975.
The
acute
(
peak)
surface
water
EEC
for
vinclozolin
is
5.68
ppb
and
for
3,5­
DCA
is
26
ppb.
The
chronic
(
annual
mean)
surface
water
EEC
for
vinclozolin
is
0.165
ppb
and
for
3,5­
DCA
is
3.12
ppb.
i.
Acute
exposure
and
risk.
For
the
population
subgroup
of
concern,
females
(
13+),
the
DWLOCs
for
vinclozolin
per
se
at
the
various
percentiles
of
exposure
are
as
follows:
0
ppb
at
the
99.9th
percentile;
4
ppb
at
the
99.85th
percentile;
30
ppb
at
the
99.8th
percentile;
47
ppb
at
the
99.75th
percentile;
80
ppb
at
the
99.6th
percentile;
and
92
at
the
99.5th
percentile.
At
all
but
the
very
highest
percentiles
of
exposure
(
99.85th
and
above),
the
DWLOC
for
vinclozolin
per
se
is
higher
than
the
EEC
of
5.68
ppb
in
surface
water
and
0.53
ppb
in
ground
water.
Given
the
level
of
refinement
in
the
vinclozolin
exposure
estimate,
using
the
highest
percentiles
of
exposure
in
estimating
risk
would
unreasonably
overstate
risk.
Therefore,
there
is
reasonable
certainty
that
exposure
to
vinclozolin
per
se
in
drinking
water
will
result
in
no
harm.
ii.
Chronic
exposure
and
risk.
The
following
chronic
DWLOCs
were
calculated
for
vinclozolin
per
se:
General
U.
S.
population,
41
ppb;
females
(
13+)
35
ppb;
and
children
(
1
 
6
years
old),
11
ppb.
The
lowest
DWLOC
of
11
ppb
for
children
1
 
6
years
old
is
higher
than
the
EEC
of
0.165
ppb
in
surface
water
and
0.53
ppb
in
ground
water.
Therefore,
there
is
reasonable
certainty
that
exposure
to
vinclozolin
in
drinking
water
will
result
in
no
harm.
3.
Non­
dietary
exposure.
From
nondietary
exposure.
There
are
no
vinclozolin
pesticide
products
registered
for
use
by
homeowners.
Therefore,
there
is
no
potential
for
homeowner
handler
exposure
to
vinclozolin
pesticide
products.
Vinclozolin
can,
however,
be
occupationally
used
in
a
manner
that
may
lead
to
post­
application
exposures
to
the
general
population,
in
particular,
golfers
playing
on
treated
golf
courses
and
homeowners
and
their
families
coming
into
contact
with
or
playing
on
sod
which
was
previously
treated
on
a
sod
farm.
A
chemical­
specific
turf
exposure
study
was
used
to
measure
human
exposure
as
well
as
residue
dissipation
over
time.
All
residential
exposures
are
considered
to
be
short­/
intermediateterm
duration
(
i.
e.,
1
day
to
1
week
and
1
week
to
several
months,
respectively),
and
the
same
endpoint
applies
to
both
durations
of
exposure.
As
the
endpoints
selected
are
from
oral
toxicity
studies
(
NOAEL
of
3
mg/
kg/
day
for
females
(
13+))
and
NOAEL
of
5
mg/
kg/
day
for
infants
and
children,
route­
to­
route
exposure
was
corrected
by
applying
a
25%
dermal
absorption
factor
and
a
100%
default
inhalation
absorption
factor
was
assumed.
A
100%
safety
factor
was
used
and
a
10X
FQPA
safety
factor
was
added
raising
the
Agency's
LOC
to
1,000.
Post­
application
risks
to
the
general
population
were
considered
for
golfers
following
treatment
of
greens,
tees,
and
fairways.
Adult
golfer
exposures,
women
(
13+),
were
less
than
the
Agency's
LOC
even
on
the
day
of
application
(
MOE
=
1,700).
Given
the
magnitude
of
the
MOE
for
adult
women
golfers,
the
Agency
does
not
believe
that
the
risks
to
child
golfers
would
exceed
the
Agency
LOC
either
because
the
skin
surface
area/
body
weight
ratio
of
the
typical
child
golfer
is
similar
to
that
of
adults
(
within
15%).
Therefore,
the
MOE
for
a
child
golfer
is
only
slightly
less
than
the
MOE
for
adult
golfers.
Since
the
risk
assessment
published
in
the
Federal
Register,
of
July
18,
2000
(
65
FR
44453)
establishing
the
tolerances
in
canola,
BASF
has
established
a
24
day
preharvest
interval
for
the
harvest
of
turf
for
transplant
into
residential
settings.
The
MOE
calculated
under
this
scenario
is
1,100
which
is
below
the
Agency's
LOC.

E.
Cumulative
Effects
Cumulative
exposure
to
substances
with
a
common
mechanism
of
toxicity.
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.''
Vinclozolin,
procymidone,
and
iprodione
are
members
of
the
imide
group
of
the
dicarboximide
class
of
fungicides.
Each
of
these
three
pesticides
can
metabolize
to
3,5­
DCA.
FQPA
requires
EPA
to
estimate
cumulative
risk
from
consumption
of
food
and
water
containing
3,5­
DCA
derived
from
vinclozolin,
iprodione,
and
procymidone.
1.
Acute
exposure
and
risk.
EPA
has
certain
evidence
that
these
compounds
induce
similar
toxic
effects
but
has
not
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yet
determined
whether
or
not
these
compounds
modulate
androgens
by
a
common
mechanism
of
toxicity.
In
fact,
there
is
evidence
that
iprodione
does
not
share
a
common
mechanism
of
toxicity
as
it
disrupts
the
endocrine
system
by
inhibiting
androgen
synthesis
rather
than
competing
for
the
androgen
receptor
as
vinclozolin
does.
In
addition,
these
three
chemicals
do
not
have
any
known
metabolites/
degradates
in
common
with
the
possible
exception
of
3,5­
DCA
which
is
structurally
and
toxicologically
different
from
the
parent
compounds
and
unlikely
to
be
an
androgen
receptor
antagonist.
EPA
has,
at
this
time,
some
data
which
suggests
that
vinclozolin
and
procymidone
have
a
common
mechanism
of
toxicity.
An
article
published
in
Toxicology
&
Industrial
Health
(
Vol.
15,
ISS
1
 
2,
1999,
pg.
80
 
93)
which
reports
the
findings
by
Dr.
Earl
Gray,
National
Health
and
Environmental
Effects
Research
Laboratory,
U.
S.
EPA,
Research
Triangle
Park,
NC,
suggests
that
procymidone
alters
sexual
differentiation
in
the
male
rat
by
acting
as
an
androgen­
receptor
antagonist
in
vivo
and
in
vitro.
The
Agency
has
yet
to
make
a
conclusion
as
to
whether
these
data
are
sufficient
to
evaluate
whether
vinclozolin
and
procymidone
have
a
common
mechanism
of
toxicity.
Even
if
it
is
assumed
that
vinclozolin
and
procymidone
share
a
common
mechanism
of
toxicity,
a
finding
of
reasonable
certainty
of
no
harm
for
vinclozolin
can
be
made
because
any
cumulative
risk
resulting
from
adding
procymidone
residues
in
wine
to
vinclozolin
exposure
is
unlikely
to
differ
significantly
from
the
risk
of
vinclozolin
alone.
This
conclusion
is
based
on
a
number
of
factors.
The
exposure
assessment
for
vinclozolin
estimates
that
vinclozolin
exposure
through
wine
grapes
contributes
<
2%
of
the
total
vinclozolin
exposure.
The
percent
of
imported
wine
grapes
that
are
treated
with
procymidone
is
similar
to
that
of
vinclozolin
(
estimated
10%
of
wine
grapes
treated
with
vinclozolin
and
9.4%
of
wine
grapes
treated
with
procymidone),
and
therefore,
the
exposure
pattern
for
these
chemicals
is
similar.
In
addition,
the
exposure
estimates
conservatively
assume
that
all
wine
bearing
vinclozolin
residues
also
contain
procymidone
residues.
In
all
likelihood,
wine
grapes
would
be
treated
with
either
vinclozolin
or
procymidone
but
not
both
chemicals.
Vinclozolin
exposure
and
procymidone
exposure
through
wine
grapes
would
each
add
<
2%
to
the
``
cumulative
exposure.''
As
noted
above,
the
acute
food­
only
risk
of
vinclozolin
is
83%
of
the
aPAD
at
the
99.8th
percentile
of
exposure,
and
the
acute
ground
water
EEC
of
0.53
ppb
and
the
acute
surface
water
EEC
of
5.68
ppb
are
lower
than
the
drinking
water
DWLOC
which
is
30
ppb
at
the
99.8th
percentile
of
exposure.
There
is
ultimately
enough
room
in
the
risk
cup
to
accommodate
vinclozolin
and
procymidone
risk,
even,
if
in
the
future,
EPA
does
determine
that
procymidone
and
vinclozolin
share
a
common
mechanism
of
toxicity.
2.
Carcinogenic
exposure
and
risk.
Since
3,5­
DCA
is
not
a
registered
pesticide,
there
is
no
FIFRA
toxicology
data
base
for
this
compound.
In
previous
risk
assessments,
EPA
has
used
the
Q1*
for
p­
chloroaniline
(
PCA)
to
assess
the
carcinogenicity
(
only
toxicological
endpoint
identified
for
3,5­
DCA)
for
other
structurally
related
chloroanilines.
EPA's
approach
on
chloroanilines
is
to
consider
chloroaniline
metabolites
to
be
toxicologically
equivalent
to
PCA
unless
there
is
sufficient
evidence
that
the
metabolite
is
not
carcinogenic.
A
Q1*
of
6.38
x
10
 
2
(
mg/
kg/
day)
has
been
calculated
for
p­
chloroaniline
based
on
the
spleen
sarcoma
rate
in
male
rats
from
a
National
Toxicology
Program
bioassay.
Exposure
to
3,5­
DCA
was
evaluated
from
the
following
sources:
Residues
of
vinclozolin­
and
iprodione­
derived
3,5­
DCA
in
food
and
wine,
residues
of
procymidone­
derived
3,5­
DCA
in
imported
wine,
and
3,5­
DCA
residues
in
water
from
domestic
agricultural
uses
of
iprodione
and
vinclozolin.
There
are
no
U.
S.
registrations
for
procymidone.
Therefore,
an
evaluation
of
exposure
to
procymidone­
derived
3,5­
DCA
in
water
is
not
appropriate.
3.
Food
risk
 
i.
From
vinclozolinderived
3,5­
DCA
residues.
Cancer
risks
were
2.6
x
10
 
7
for
all
crops,
excluding
strawberries
and
stone
fruits.
BASF
notes
that
the
last
day
for
legal
use
of
vinclozolin
in
either
strawberries
or
stonefruit
was
January
2000.
In
effect
neither
commodity
has
been
treated
with
vinclozolin
since
the
1999
use
season.
In
addition,
the
last
day
for
legal
use
of
vinclozolin
on
onions
and
raspberries
was
December
15,
2001.
As
a
result
the
theoretical
cancer
risk
calculated
is
an
overestimation
and
these
risks
do
not
exceed
the
Agency's
LOC.
ii.
From
iprodione­
derived
3,5­
DCA
residues.
As
stated
in
the
July
1998
Iprodione
RED
fact
sheet,
the
cancer
risk
associated
with
3,5­
DCA
derived
from
iprodione
was
6
x
10
 
9.
This
risk
does
not
exceed
the
Agency's
LOC.
iii.
From
procymidone­
derived
3,5­
DCA
residues.
The
cancer
risk
associated
with
3,5­
DCA
in
imported
wine
produced
from
grapes
treated
with
procymidone
was
estimated
to
be
3.7
x
10
 
7.
This
risk
does
not
exceed
the
Agency's
LOC.
4.
Drinking
water
risk
 
i.
From
vinclozolin
derived
3,5­
DCA.
Since
the
use
on
onions
has
been
eliminated,
the
carcinogenic
DWLOC
for
3,5­
DCA
(
based
on
the
commodities
currently
available
for
consumption)
has
been
calculated
to
range
from
0.46
ppb
to
1.6
ppb.
Using
Tier
II
PRZM/
EXAMS,
the
modeled
EECs
are
0.64
ppb
for
lettuce
and
0.34
ppb
for
canola.
The
use
site
which
represents
the
highest
modeled
exposure
in
drinking
water
is
golf
courses.
Application
to
golf
course
turf
is
currently
permitted
on
grass
mowed
at
1
inch
or
less.
Using
the
Tier
I
generic
expected
environmental
concentration
(
GENEEC)
model,
the
Agency
has
calculated
a
chronic
EEC
of
0.29
ppb
based
on
application
to
tees
and
greens
and
a
chronic
EEC
of
2.33
ppb
assuming
application
to
tees,
greens,
and
fairways.
These
EECs
were
the
result
of
refinements
to
the
GENEEC
model.
These
refinements
included
the
incorporation
of
an
87
percent
crop
area
factor
as
well
as
the
percentage
of
the
golf
course
that
actually
receives
pesticide
treatment,
bringing
the
resulting
PCA
factor
down
to
17%.
It
was
assumed
that
tees
and
greens
comprise
2.8%
of
the
acreage
of
a
golf
course.
When
fairways
are
included,
an
additional
16.7%
of
the
golf
course
is
treated.
The
EEC
of
2.33
ppb
exceeds
the
DWLOC.
In
evaluating
whether
this
EEC
indicated
a
risk
of
concern
EPA
considered
the
following
factors:
ii.
The
drinking
water
assessment
on
turf
is
based
on
GENEEC,
a
screeninglevel
Tier
I
model.
At
present,
PRZMEXAMS
the
Tier
II
model,
does
not
have
the
appropriate
parameters
to
accurately
model
turf
runoff.
Although
GENEEC
is
not
an
ideal
tool
for
use
in
drinking
water
risk
assessments,
it
can
provide
high­
end
estimates
of
the
concentrations
that
might
be
found
in
a
confined
pond
of
one
hectare.
Drinking
water
from
surface
water
sources
does
not
typically
come
from
this
type
of
scenario,
but
rather
from
bodies
of
water
that
are
substantially
larger
than
such
ponds
and
from
diverse
watersheds.
Unlike
a
confined
pond,
there
is
always
some
flow
(
in
a
river)
or
turn
over
(
in
a
lake
or
reservoir)
resulting
in
an
overestimation
of
the
persistence
of
the
chemicals
near
the
drinking
water
utility
intakes.
Although
a
PCA
of
17%
was
used
to
refine
the
model,
the
Agency
recognizes
that
there
are
still
uncertainties
in
the
accuracy
of
the
model
to
represent
drinking
water
concentrations.

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/
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/
Notices
iii.
The
GENEEC
model
uses
the
56
 
day
average
of
pesticide
concentrations
immediately
after
an
event
(
application
of
pesticide).
This
short
time­
period
may
not
adequately
characterize
a
person's
average
daily
exposure
over
a
year,
even
more
so,
over
a
life
time
of
70
years.
iv.
The
GENEEC
model
assumes
that
once
in
every
10
years
the
EEC
will
be
exceeded.
For
the
other
9
out
of
10
years
the
level
of
residue
in
drinking
water
is
likely
to
be
below
the
EEC
with
at
least
one
half
of
the
years
falling
significantly
below
by
a
factor
of
5
to
10.
Therefore,
a
person
may
be
exposed
to
the
EEC
once
in
every
10
years
or
a
total
of
7
times
during
a
lifetime
of
70
years.
The
Agency
believes
the
potential
for
such
a
lifetime
exposure
is
minimal.
v.
Iprodione
3,5­
DCA.
As
stated
in
the
RED,
the
DWLOC
for
3,5­
DCA
derived
from
domestic
uses
of
iprodione
was
estimated
to
be
0.55
ppb.
The
3,5­
DCA
EEC
in
surface
water
associated
with
the
use
of
iprodione
alone
was
estimated
to
be
0.45
ppb.
Thus,
the
iprodione
derived
3,5­
DCA
carcinogenic
DWLOC
is
not
exceeded.
vi.
From
procymidone
3,5­
DCA.
There
is
no
drinking
water
exposure
because
procymidone
is
not
registered
for
use
in
the
United
States.
The
cumulative,
food­
only
cancer
risk
associated
with
3,5­
DCA
derived
from
all
three
of
these
imide
fungicides
is
6.3
x
10
 
7
when
stone
fruit
and
strawberries
are
excluded
from
consideration.
There
is
uncertainty
in
the
above
risk
estimates
in
that
a
surrogate
Q1*
is
being
used
for
3,5­
DCA.
However,
due
to
the
structural
similarities
of
3,5­
DCA
and
pchloroaniline
(
PCA),
EPA
believes
that
for
3,5­
DCA,
the
use
of
the
PCA
Q1*
represents
an
upper­
bound
estimate.
The
3,5­
DCA
DWLOC
from
all
three
imide
fungicides
and
those
currently
registered
vinclozolin
uses
which
are
not
being
supported
after
this
use
season
ranges
from
0.26
ppb
to
1.4
ppb.
The
estimated
concentration
of
3,5­
DCA
in
water
from
applications
of
iprodione
(
1998
iprodione
RED)
is
0.45
ppb
and
falls
within
the
range
of
the
aggregated
DWLOC
cited
above.
The
estimated
concentration
of
3,5­
DCA
in
water
from
applications
of
vinclozolin
is
estimated
to
range
from
0.29
ppb
to
2.33
ppb.
As
already
stated,
this
range
could
potentially
present
a
risk
of
concern
based
on
the
model,
however,
based
on
how
the
model
estimates
residue
concentrations
for
cancer
assessment,
it
is
unlikely
that
a
cancer
risk
of
concern
is
present.

F.
Safety
Determination
1.
U.
S.
population
 
i.
Acute
risk.
The
acute
dietary
(
food
only)
risk
does
not
exceed
the
Agency's
LOC
at
the
percentiles
of
exposure
up
to
the
99.8th
percentile.
Using
anticipated
residues,
PCT
data,
and
PICT
data,
the
population
subgroup
of
concern,
females
(
13+)
utilized
83%
of
the
dietary
(
food
only)
aPAD
at
the
99.8th
percentile
of
exposure.
For
drinking
water,
the
EEC
of
5.68
ppb
in
surface
water
and
the
EEC
of
0.53
in
ground
water
did
not
exceed
the
DWLOC
of
30
ppb
at
the
99.8th
percentile
of
exposure.
ii.
Chronic
risk.
Using
the
exposure
assumptions
described
above,
aggregate
dietary
exposure
to
the
U.
S.
population
will
use
4%
of
the
cPAD
and
exposure
to
the
most
highly
exposed
population
subgroup,
children
(
1
 
6
year
old)
will
use
7%
of
the
cPAD.
The
chronic
DWLOCs
for
vinclozolin
were
41
ppb
for
the
general
U.
S.
population
and
35
ppb
for
the
most
highly
exposed
population
subgroup,
women
(
13+).
The
chronic
DWLOCs
were
higher
than
the
chronic
EEC
of
0.53
ppb
in
ground
water
and
0.165
ppb
in
surface
water.
EPA
generally
has
no
concern
for
exposures
below
100%
of
the
cPAD
because
the
cPAD
represents
the
level
at
or
below
which
daily
aggregate
dietary
exposure
over
a
lifetime
will
not
pose
appreciable
risks
to
human
health.
2.
Short­
and
intermediate­
term
risk.
Short­
and
intermediate­
term
aggregate
exposure
takes
into
account
chronic
dietary
food
and
water
(
considered
to
be
a
background
exposure
level)
plus
indoor
and
outdoor
residential
exposure.
All
residential
exposures
are
considered
to
be
short­
and
intermediate­
term
duration
and
since
the
same
endpoint
applies
to
both
durations
of
exposures,
the
dermal
and
inhalation
exposures
must
be
aggregated
together
with
the
food
and
water
exposures
for
each
population
subgroup
of
concern,
females
(
13+)
and
infants
and
children.
Since
the
risk
assessment
published
in
the
Federal
Register
of
July
18,
2000
(
65
FR
44453),
establishing
the
tolerances
in
canola,
BASF
has
established
a
24
 
day
preharvest
interval
for
the
harvest
of
turf
for
transplant
into
residential
settings.
The
MOE
calculated
under
this
scenario
is
1,100
which
is
below
the
Agency's
LOC.
3.
Aggregate
cancer
risk
for
U.
S.
population.
Because
the
overall
antiandrogenic
effects
are
a
prerequisite
for
hyperplasia
and
tumor
formation,
and
are
considered
to
be
protective
of
the
potential
carcinogenic
outcome
of
exposure
to
the
anti­
androgenic
vinclozolin
and
its
metabolites,
the
overall
anti­
androgenic
aggregate
risk
which
are
identical
to
the
chronic
aggregate
risk.
The
chronic
aggregate
risks
are
presented.
The
chronic
(
noncancer
aggregate
risk
was
below
the
Agency's
LOC
for
food
and
drinking
water
sources
of
exposure.
Chronic
food­
source
risks
were
less
than
or
equal
to
7%
of
the
cPAD
when
stone
fruit
and
strawberries
are
excluded
(
uses
have
been
canceled).
EECs
were
compared
to
the
chronic
DWLOCs.
The
chronic
EEC
for
residues
of
vinclozolin
per
se
in
ground
water
(
0.53
ppb)
was
below
the
chronic
DWLOCs
for
water
consumption
by
adults
(
41
ppb
for
the
general
U.
S.
population
and
35
ppb
for
females
(
13+))
and
by
children
(
11
ppb).
Cancer
risks
from
vinclozolin
derived
3,5­
DCA
were
2.6
x
10
 
7
for
all
crops,
excluding
strawberries
and
stone
fruits.
This
risk
does
not
exceed
the
Agency's
LOC.
The
3,5­
DCA
DWLOC
from
all
three
imide
fungicides
(
including
canola,
succulent
beans,
onions,
and
raspberries)
ranges
from
0.26
ppb
to
1.4
ppb.
It
should
be
noted
that
vinclozolin
is
no
longer
used
in
onions
and
raspberries.
The
3,5­
DCA
EEC
resulting
from
iprodione
use
is
0.45
ppb
and
falls
with
the
range
of
the
aggregated
DWLOC
cited
above.
The
3,5­
DCA
EEC
resulting
from
vinclozolin
use
is
estimated
to
range
from
0.29
ppb
to
2.33
ppb.
As
already
stated,
this
range
could
potentially
present
a
risk
of
concern
based
on
the
model,
however,
based
on
how
the
model
estimates
residue
concentrations
for
cancer
assessment,
it
is
unlikely
that
a
cancer
risk
of
concern
is
present.
4.
Determination
of
safety.
Based
on
these
risk
assessments,
there
is
a
reasonable
certainty
that
no
harm
will
result
from
aggregate
exposure
to
vinclozolin
residues.
5.
Infants
and
children.
In
assessing
the
potential
for
additional
sensitivity
of
infants
and
children
to
residues
of
vinclozolin,
EPA
considered
data
from
developmental
toxicity
studies
in
the
rat
and
rabbit
and
a
2­
generation
reproduction
study
in
the
rat.
The
developmental
toxicity
studies
are
designed
to
evaluate
adverse
effects
on
the
developing
organism
resulting
from
maternal
pesticide
exposure
during
gestation.
Reproduction
studies
provide
information
relating
to
effects
from
exposure
to
the
pesticide
on
the
reproductive
capability
of
mating
animals
and
data
on
systemic
toxicity.
FFDCA
section
408
provides
that
EPA
shall
apply
an
additional
tenfold
margin
of
safety
for
infants
and
children
in
the
case
of
threshold
effects
to
account
for
prenatal
and
postnatal
toxicity
and
the
completeness
of
the
data
base
unless
EPA
determines
that
a
different
margin
of
safety
will
be
safe
for
infants
and
children.

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26,
2003
/
Notices
6.
Prenatal
and
postnatal
sensitivity.
The
rationale
for
retaining
the
10X
FQPA
safety
factor
is
explained
below:
i.
There
is
evidence
of
increased
susceptibility
of
offspring
following
in
utero
exposure
to
vinclozolin
in
the
prenatal
developmental
toxicity
study
in
rats.
ii.
A
developmental
neurotoxicity
study
in
rats
with
an
expanded
protocol
is
required
for
vinclozolin
as
a
result
of
concern
for
the
anti­
androgenic
properties
of
vinclozolin
and
its
metabolites.

G.
Conclusion
Based
on
the
developmental
and
reproductive
data
for
vinclozolin,
EPA
determined
that
an
additional
10X
safety
factor
for
the
protection
of
infants
and
children
(
as
required
by
FQPA)
should
be
retained.
1.
Acute
risk.
No
study
with
vinclozolin
indicated
that
acute
exposure
to
vinclozolin
is
likely
to
cause
an
adverse
effect
of
concern
on
infants
or
children
or
the
general
public
with
the
exception
of
the
in
utero
effects
on
the
developing
fetus.
Risks
to
the
fetus
are
estimated
by
examining
exposure
to
women
of
child­
bearing
age.
2.
Chronic
risk.
Using
the
exposure
assumptions
described
in
this
unit,
it
is
concluded
that
aggregate
exposure
to
vinclozolin
from
food
will
utilize
7%
of
the
cPAD
for
infants
and
children.
EPA
generally
has
no
concern
for
exposures
below
100%
of
the
cPAD
because
the
cPAD
represents
the
level
at
or
below
which
daily
aggregate
dietary
exposure
over
a
lifetime
will
not
pose
appreciable
risks
to
human
health.
Since
the
EEC's
for
residues
of
vinclozolin
per
se
are
lower
than
the
chronic
DWLOC's,
aggregate
exposure
will
not
exceed
100%
of
the
cPAD.
3.
Short­
or
intermediate­
term
risk.
The
MOE
is
greater
than
or
equal
to
1,010
for
aggregate
risks
to
infants
and
children
resulting
from
use
of
vinclozolin.
Therefore,
the
risks
do
not
exceed
the
Agency's
LOC.
4.
Determination
of
safety.
Based
on
these
risk
assessments,
there
is
a
reasonable
certainty
that
no
harm
will
result
to
infants
and
children
from
aggregate
exposure
to
vinclozolin
residues.

H.
International
Tolerances
CODEX
maximum
residue
limits
(
MRLs)
for
residues
of
vinclozolin
and
its
metabolites
containing
the
3,5­
DCA
moiety
have
been
established
in
common
bean
at
2
ppm,
rape
seed
at
1
ppm
(
no
limit
for
canola),
cattle
meat
and
milk
at
0.5
ppm,
and
chicken
meat
and
eggs
at
0.05
ppm.
No
Canadian
or
Mexican
tolerances
have
been
established
for
vinclozolin
residues
in
succulent
beans,
rape,
canola,
meat,
milk,
poultry,
or
eggs.
The
CODEX
MRLs
for
canola
(
rapeseed),
cattle
meat,
cattle
milk,
and
poultry
eggs
are
in
harmony
with
the
proposed
tolerances
associated
with
this
petition.
The
chicken
meat
MRL
(
0.05
ppm)
is
not
in
harmony
with
the
proposed
tolerance
in
poultry
meat
(
0.1
ppm)
due
to
recovery
discrepancies
with
the
analytical
method.
[
FR
Doc.
03
 
7246
Filed
3
 
25
 
03;
8:
45
am]

BILLING
CODE
6560
 
50
 
S
ENVIRONMENTAL
PROTECTION
AGENCY
[
OPP
 
2002
 
0324;
FRL
 
7282
 
2]

Revised
Final
Health
Effects
Test
Guideline;
Skin
Sensitization;
Notice
of
Availability
AGENCY:
Environmental
Protection
Agency
(
EPA).
ACTION:
Notice.

SUMMARY:
With
this
notice,
EPA
is
announcing
the
availability
of
the
revised
final
test
guideline
for
Series
870
 
Health
Effects
Test
Guidelines,
OPPTS
870.2600
Skin
Sensitization.
EPA
has
established
a
unified
library
for
test
guidelines
issued
by
the
Office
of
Prevention,
Pesticides
and
Toxic
Substances
(
OPPTS)
for
use
in
testing
chemical
substances
to
develop
data
for
submission
to
EPA
under
the
Toxic
Substances
Control
Act
(
TSCA),
the
Federal
Food,
Drug,
and
Cosmetic
Act
(
FFDCA),
or
the
Federal
Insecticide,
Fungicide,
and
Rodenticide
Act
(
FIFRA).
These
test
guidelines
represent
an
Agency
effort
that
began
in
1991
to
harmonize
the
test
guidelines
within
OPPTS,
as
well
as
to
harmonize
the
OPPTS
test
guidelines
with
those
of
the
Organization
for
Economic
Cooperation
and
Development
(
OECD).
The
process
for
developing
and
amending
these
test
guidelines
includes
public
participation
and
the
extensive
involvement
of
the
scientific
community,
as
warranted,
including
peer
review
by
the
Scientific
Advisory
Panel
(
SAP),
the
Scientific
Advisory
Board
(
SAB)
and
other
expert
scientific
organizations,
as
well
as
determination
of
validation
status
by
the
Interagency
Coordinating
Committee
for
Validation
of
Alternative
Methods
(
ICCVAM).

FOR
FURTHER
INFORMATION
CONTACT:
For
general
information
contact:
TSCA
information
contact:
TSCA
Hotline
at
TAIS/
7408,
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460
 
0001;
telephone
number:
(
202)
554
 
1404;
e­
mail
address:
TSCA­
Hotline@
epa.
gov.
FIFRA
information
contact:
Communications
Services
Branch
(
7506C),
Field
and
External
Affairs
Division,
Office
of
Pesticide
Programs,
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460
 
0001;
telephone
number:
(
703)
305
 
5017;
fax
number:
(
703)
305
 
5558.
For
FIFRA
technical
information
contact:
Deborah
McCall,
Registration
Division
(
7505C),
Office
of
Pesticide
Programs,
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460
 
0001;
telephone
number:
(
703)
305
 
7109
e­
mail
address:
mccall.
deborah@
epa.
gov.
For
TSCA
technical
information
contact:
Ronald
Ward,
Ph.
D.,
Risk
Assessment
Division
(
7403M),
Office
of
Pollution
Prevention
and
Toxics,
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460
 
0001;
telephone
number:
(
202)
564
 
8926;
e­
mail
address:
ward.
ron@
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
are
or
may
be
required
to
conduct
testing
of
chemical
substances
under
TSCA,
FFDCA,
or
FIFRA,
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
applicability
of
this
action
to
a
particular
entity,
consult
the
person
listed
under
FOR
FURTHER
INFORMATION
CONTACT.

II.
How
Can
I
Get
Copies
of
This
Document
and
Other
Related
Information?

A.
Docket
EPA
has
established
an
official
public
docket
for
this
action
under
docket
identification
(
ID)
number
OPP
 
2002
 
0324.
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
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