Document ID: EPA-HQ-OPP-2002-0250-0001
Agency: epa
Document Type: Notice
Title: Fenarimol; Availability of the Risk Assessments on FQPA Tolerance Reassessment Progress and
Tolerance Reassessment Decision (TRED)
Posted Date: 2002-12-04T05:00Z

72170
Federal
Register
/
Vol.
67,
No.
233
/
Wednesday,
December
4,
2002
/
Notices
The
sum
of
these
adjustments
is
a
decrease
of
57,855
responses
and
7,134,152
burden
hours
from
the
current
approved
total.
According
to
the
procedures
prescribed
in
5
CFR
1320.12,
EPA
has
submitted
this
ICR
to
OMB
for
review
and
approval.
Any
comments
related
to
the
renewal
of
this
ICR
should
be
submitted
within
30
days
of
this
notice,
as
described
above.

Dated:
November
22,
2002.
Oscar
Morales,
Director,
Collection
Strategies
Division,
Office
of
Environmental
Information.
[
FR
Doc.
02
 
30762
Filed
12
 
3
 
02;
8:
45
am]

BILLING
CODE
6560
 
50
 
P
ENVIRONMENTAL
PROTECTION
AGENCY
[
OPP
 
2002
 
0250;
FRL
 
7274
 
7]

Fenarimol;
Availability
of
the
Risk
Assessments
on
FQPA
Tolerance
Reassessment
Progress
and
Tolerance
Reassessment
Decision
(
TRED)

AGENCY:
Environmental
Protection
Agency
(
EPA).
ACTION:
Notice.

SUMMARY:
This
notice
announces
the
availability
of
EPA's
tolerance
reassessment
decision
and
related
documents
for
fenarimol
including
the
Fenarimol
Overview,
Fenarimol
Summary,
Fenarimol
Decision
Document
(
TRED),
and
supporting
risk
assessment
documents.
EPA
has
reassessed
the
42
tolerances,
or
legal
limits,
for
residues
of
fenarimol
in
or
on
raw
agricultural
commodities.
These
tolerances
are
now
considered
safe
under
the
Federal
Food,
Drug,
and
Cosmetic
Act
(
FFDCA),
as
amended
by
the
Food
Quality
Protection
Act
(
FQPA)
of
1996.
DATES:
Comments
on
the
tolerance
reassessment
decision
or
on
the
human
health
effects
risk
assessment
for
fenarimol,
identified
by
docket
ID
number
OPP
 
2002
 
0250,
must
be
received
by
EPA
on
or
before
January
3,
2003.
In
the
absence
of
substantive
comments,
the
tolerance
reassessment
decision
will
be
considered
final.
ADDRESSES:
Comments
may
be
submitted
by
mail,
electronically,
or
in
person.
Please
follow
the
detailed
instructions
for
each
method
as
provided
in
Unit
I.
of
the
SUPPLEMENTARY
INFORMATION.
To
ensure
proper
receipt
by
EPA,
it
is
imperative
that
you
identify
docket
ID
number
OPP
 
2002
 
0250
in
the
subject
line
on
the
first
page
of
your
response.
FOR
FURTHER
INFORMATION
CONTACT:
Tom
Myers,
Special
Review
and
Reregistration
Division
(
7508C),
Office
of
Pesticide
Programs,
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460;
telephone
number:
(
703)
308
 
8589;
email
address:
myers.
tom@
epa.
gov.
SUPPLEMENTARY
INFORMATION:

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

This
action
is
directed
to
the
public
in
general,
but
will
be
of
interest
to
a
wide
range
of
stakeholders,
including
environmental,
human
health,
and
agricultural
advocates;
the
chemical
industry;
pesticide
users;
and
members
of
the
public
interested
in
the
use
of
pesticides.
The
Agency
has
not
attempted
to
describe
all
the
persons
or
entities
who
may
be
interested
in
or
affected
by
this
action.
If
you
have
questions
in
this
regard,
consult
the
person
listed
under
FOR
FURTHER
INFORMATION
CONTACT.

B.
How
Can
I
Get
Additional
Information,
Including
Copies
of
this
Document
and
Other
Related
Documents?

1.
Electronically.
You
may
obtain
electronic
copies
of
this
document,
and
certain
other
related
documents
that
might
be
available
electronically,
from
the
EPA
Internet
Home
Page
at
http://
www.
epa.
gov/.
To
access
this
document,
on
the
Home
Page
select
``
Laws
and
Regulations,''
``
Regulations
and
Proposed
Rules,''
and
then
look
up
the
entry
for
this
document
under
the
``
Federal
Register
 
Environmental
Documents.''
You
can
also
go
directly
to
the
Federal
Register
listings
at
http://
www.
epa.
gov/
fedrgstr/.
You
can
obtain
copies
of
the
TRED
and
related
documents
discussed
in
this
notice
on
EPA's
website
at
http://
www.
epa.
gov/
pesticides/
reregistration/
status.
htm.
Information
on
pesticide
reregistration
and
tolerance
reassessment,
including
the
purpose
and
status
of
Agency
programs
to
complete
Reregistration
Eligibility
Decisions
(
REDs),
Interim
REDs,
and
tolerance
reassessment
decisions
(
TREDs),
is
available
at
http://
www.
epa.
gov/
pesticides/
reregistration.
General
information
is
available
on
the
Office
of
Pesticide
Programs'
home
page,
http://
www.
epa.
gov/
pesticides/.
2.
In
person.
The
Agency
has
established
an
official
record
for
this
action
under
docket
ID
numbers
OPP
 
2002
 
0250.
The
official
record
consists
of
the
documents
specifically
referenced
in
this
action,
and
other
information
related
to
this
action,
including
any
information
claimed
as
Confidential
Business
Information
(
CBI).
This
official
record
includes
the
documents
that
are
physically
located
in
the
docket,
as
well
as
the
documents
that
are
referenced
in
those
documents.
The
public
version
of
the
official
record
does
not
include
any
information
claimed
as
CBI.
The
public
version
of
the
official
record,
which
includes
printed,
paper
versions
of
any
electronic
comments
submitted
during
an
applicable
comment
period
is
available
for
inspection
in
the
Public
Information
and
Records
Integrity
Branch
(
PIRIB),
Rm.
119,
Crystal
Mall
#
2,
1921
Jefferson
Davis
Hwy.,
Arlington,
VA,
from
8:
30
a.
m.
to
4
p.
m.,
Monday
through
Friday,
excluding
legal
holidays.
The
PIRIB
telephone
number
is
(
703)
305
 
5805.

C.
How
and
to
Whom
Do
I
Submit
Comments?
You
may
submit
comments
through
the
mail,
in
person,
or
electronically.
To
ensure
proper
receipt
by
EPA,
it
is
imperative
that
you
identify
docket
ID
number
OPP
 
2002
 
0250
in
the
subject
line
on
the
first
page
of
your
response.
1.
By
mail.
Submit
your
comments
to:
Public
Information
and
Records
Integrity
Branch
(
PIRIB),
Information
Resources
and
Services
Division
(
7502C),
Office
of
Pesticide
Programs
(
OPP),
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460.
2.
In
person
or
by
courier.
Deliver
your
comments
to:
Public
Information
and
Records
Integrity
Branch
(
PIRIB),
Information
Resources
and
Services
Division
(
7502C),
Office
of
Pesticide
Programs
(
OPP),
Environmental
Protection
Agency,
Rm.
119,
Crystal
Mall
#
2,
1921
Jefferson
Davis
Hwy.,
Arlington,
VA.
The
PIRIB
is
open
from
8:
30
a.
m.
to
4
p.
m.,
Monday
through
Friday,
excluding
legal
holidays.
The
PIRIB
telephone
number
is
(
703)
305
 
5805.
3.
Electronically.
You
may
submit
your
comments
electronically
by
e­
mail
to:
opp­
docket@
epa.
gov,
or
you
can
submit
a
computer
disk
as
described
in
this
unit.
Do
not
submit
any
information
electronically
that
you
consider
to
be
CBI.
Avoid
the
use
of
special
characters
and
any
form
of
encryption.
Electronic
submissions
will
be
accepted
in
WordPerfect
6.1/
8.0/
9.0
or
ASCII
file
format.
All
comments
in
electronic
form
must
be
identified
by
docket
ID
number
OPP
 
2002
 
0250.
Electronic
comments
may
also
be
filed
online
at
many
Federal
Depository
Libraries.

D.
How
Should
I
Handle
CBI
that
I
Want
to
Submit
to
the
Agency?
Do
not
submit
any
information
electronically
that
you
consider
to
be
CBI.
You
may
claim
information
that
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72171
Federal
Register
/
Vol.
67,
No.
233
/
Wednesday,
December
4,
2002
/
Notices
you
submit
to
EPA
in
response
to
this
document
as
CBI
by
marking
any
part
or
all
of
that
information
as
CBI.
Information
so
marked
will
not
be
disclosed
except
in
accordance
with
procedures
set
forth
in
40
CFR
part
2.
In
addition
to
one
complete
version
of
the
comment
that
includes
any
information
claimed
as
CBI,
a
copy
of
the
comment
that
does
not
contain
the
information
claimed
as
CBI
must
be
submitted
for
inclusion
in
the
public
version
of
the
official
record.
Information
not
marked
confidential
will
be
included
in
the
public
version
of
the
official
record
without
prior
notice.
If
you
have
any
questions
about
CBI
or
the
procedures
for
claiming
CBI,
please
consult
the
person
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.
Offer
alternative
ways
to
improve
the
notice
or
collection
activity.
7.
Make
sure
to
submit
your
comments
by
the
deadline
in
this
notice.
8.
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
reassessed
the
risks
associated
with
current
food
uses
of
the
pesticide
fenarimol,
reassessed
42
existing
tolerances,
and
reached
a
tolerance
reassessment
and
risk
management
decision.
The
Agency
is
issuing
for
comment
the
resulting
report
on
FQPA
tolerance
reassessment
progress,
including
the
Fenarimol
Overview,
Fenarimol
Summary,
Fenarimol
Decision
Document
(
TRED),
and
supporting
risk
assessment
documents.
EPA
must
review
tolerances
and
tolerance
exemptions
that
were
in
effect
when
FQPA
was
enacted
in
August
1996,
to
ensure
that
these
existing
pesticide
residue
limits
for
food
and
feed
commodities
meet
the
safety
standard
established
by
the
new
law.
Tolerances
are
considered
reassessed
once
the
safety
finding
has
been
made
or
a
revocation
occurs.
EPA
has
reviewed
and
made
the
requisite
safety
finding
for
the
tolerances
and
exemptions
included
in
this
notice.
EPA
approved
registration
of
products
containing
fenarimol
as
an
active
ingredient
prior
to
the
1996
enactment
of
the
Food
and
Quality
Protection
Act;
therefore,
while
no
reregistration
decision
is
required
at
present,
risks
from
non­
occupational
exposure
to
fenarimol
through
food,
drinking
water,
and
residential
uses
must
be
reassessed.
The
Agency
has
evaluated
the
dietary
risk
associated
with
fenarimol
and
has
determined
that
there
is
a
reasonable
certainty,
with
appropriate
mitigation,
that
no
harm
to
any
population
subgroup
will
result
from
aggregate
exposure
to
fenarimol
when
considering
dietary
exposure
and
all
other
nonoccupational
sources
of
pesticide
exposure
for
which
there
is
reliable
information.
Residential
postapplication
exposure
was
of
concern
for
children
and
infants
from
fenarimol
products
applied
in
residential
settings.
To
mitigate
this
risk,
the
registrant
has
agreed
to
remove
the
residential
uses
from
their
labels
until
they
conduct
a
special
developmental
toxicity
study
that
will
assess
possible
effects
of
fenarimol
on
the
adult
and
juvenile
rat
hormonal
systems.
Once
these
data
are
submitted
and
reviewed,
the
Agency
will
make
a
determination
regarding
the
reinstatement
of
the
residential
uses.
For
chronic
drinking
water
risk
from
surface
water,
potential
(
average)
estimated
environmental
concentrations
(
EECs)
of
fenarimol
(
84
parts
per
billion
(
ppb))
exceeds
the
chronic
drinking
water
level
of
comparison
(
DWLOC)
for
all
populations.
The
84
ppb
value
includes
all
residential
uses
and
the
golf
course
use
of
fenarimol.
However,
with
the
residential
uses
removed
from
the
label,
a
correction
factor
of
0.31
can
be
applied
to
the
84
ppb
surface
water
number
to
account
for
the
use
of
fenarimol
only
on
tees,
greens,
and
fairways
on
golf
courses.
This
would
reduce
the
chronic
EEC
to
26
ppb.
Infants
and
children,
the
most
sensitive
population
subgroups
would
still
exceed
the
chronic
DWLOC
of
20.
However,
the
chronic
EECs
were
estimated
using
Tier
I
modeling
and
only
slightly
exceed
the
DWLOC.
Additional
data
are
being
required
that
will
provide
important
information
on
the
mobility
of
fenarimol
and
its
degradates.
These
studies
will
help
to
refine
the
chronic
surface
water,
ground
water,
and
drinking
water
risk
assessments.
The
Agency
has
reassessed
all
42
tolerances
for
fenarimol
and
can
make
a
FQPA
safety
determination.
In
addition,
available
residue
chemistry
data
support
the
establishment
of
a
0.02
part
per
million
(
ppm)
permanent
tolerance
for
fenarimol
residues
in
filberts
under
40
CFR
180.421
(
a).
The
Agency
has
sufficient
residue
data
for
reassessing
the
tolerances
for
fenarimol.
The
chronic
dietary
exposure
assessment
for
fenarimol
is
highly
refined
using
anticipated
residues
based
on
1996
 
1999
Food
and
Drug
Administration
(
FDA)
monitoring
data
for
apples,
bananas,
cherries,
grapes,
and
pears.
Field
trial
residue
data
were
used
for
pecans
and
filberts.
Percent
crop
treated
information
and
processing
factors,
where
available,
were
used
in
the
assessment.
There
were
no
U.
S.
Department
of
Agriculture
Pesticide
Data
Program
monitoring
data
available
for
fenarimol.
Residues
of
fenarimol
per
se
were
non­
detectable
(
below
the
method
limit
of
detection
(
LOD))
in
all
1996
 
1999
FDA
monitoring
samples
of
apples,
bananas,
grapes,
and
pears
(
a
total
of
more
than
3,000
samples).
Out
of
214
cherry
samples,
three
had
detectable
residues.
Residues
of
fenarimol
per
se
were
non­
detectable
<
LOD
in/
on
all
but
one
pecan
nut
meat
sample
from
seven
trials.
There
were
no
detectable
residues
in
filbert
samples
from
four
field
trials.
Chronic
dietary
risks
from
exposure
do
not
exceed
the
Agency's
level
of
concern.
EPA
works
with
affected
parties
to
reach
the
tolerance
reassessment
decisions.
The
Agency
therefore
is
issuing
the
fenarimol
decision
as
a
final
decision
with
a
public
comment
period.
All
comments
received
during
the
public
comment
period
will
be
carefully
considered
by
the
Agency.
If
any
comment
significantly
affects
the
Agency's
decision,
EPA
will
publish
an
amendment
to
the
decision
in
the
Federal
Register.
In
the
absence
of
substantive
comments,
the
tolerance
reassessment
decisions
reflected
here
will
be
considered
final.

List
of
Subjects
Environmental
protection,
Chemicals,
Pesticides
and
pests.

Dated:
November
15,
2002.

Betty
Shackleford,

Acting
Director,
Special
Review
and
Reregistration
Division,
Office
of
Pesticide
Programs.
[
FR
Doc.
02
 
30471
Filed
12
 
3
 
02
8:
45
am]

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