Document ID: EPA-HQ-OPP-2002-0069-0001
Agency: epa
Document Type: Notice
Title: Methodology for Lower Toxicity Pesticide Chemicals; Notice of Availability.
Posted Date: 2002-06-13T04:00Z

40732
Federal
Register
/
Vol.
67,
No.
114
/
Thursday,
June
13,
2002
/
Notices
TABLE
1.—
REGISTRATIONS
WITH
REQUESTS
FOR
AMENDMENTS
TO
DELETE
USES
IN
CERTAIN
PESTICIDE
REGISTRATIONS—
Continued
Registration
no.
Product
Chemical
Name
Delete
From
Label
067760–
00044
Dimethoate
4
E
Dimethoate
Residential
and
housefly
uses
068156–
00004
Dintec
HFP
Trifluralin
Trifluralin
Rapeseed
EPA
company
numbers
000264,
002217,
040083,
042750
and
067760
have
requested
a
30–
day
comment
period
for
registrations
listed.

Users
of
these
products
who
desire
continued
use
on
crops
or
sites
being
deleted
should
contact
the
applicable
registrant
listed
in
Table
2
below
before
December
10,
2002,
to
discuss
withdrawal
of
the
application
for
amendment.
This
180–
day
period
will
also
permit
interested
members
of
the
public
to
intercede
with
registrants
prior
to
the
Agency's
approval
of
the
deletion.
Table
2
includes
the
names
and
addresses
of
record
for
all
registrants
of
the
products
in
Table
1,
in
sequence
by
EPA
company
number.

TABLE
2.—
REGISTRANTS
REQUESTING
VOLUNTARY
CANCELLATION
EPA
Company
no.
Company
Name
and
Address
000264
Aventis
Cropscience
USA
LP,
2
T.
W.
Alexander
Drive
Box
12014,
Research
Triangle
Park,
NC
27709.

001386
Universal
Cooperatives
Inc.,
1300
Corporate
Center
Curve,
Eagan,
MN
55121.

002217
PBI/
Gordon
Corp.,
Attn:
Craig
Martens,
Box
014090,
Kansas
City,
MO
64101.

008660
Earth
Care,
Division
of
United
Industries
Corporatio,
Box
142642,
St.
Louis,
MO
63114.

010163
Gowan
Co.,
Box
5569,
Yuma,
AZ
85366.

040083
Inquinosa
Internacional,
S.
A.,
Paseo
De
La
Castellance,
123,
9
B,
28046
Mardr,
.

042750
Pyxis
Regulatory
Consulting,
Agent
For:
Albaugh
Inc.,
11324
17th
Ave.
Ct.
NW,
Gig
Harbor,
WA
98332.

062719
Dow
AgroSciences
LLC,
9330
Zionsville
Rd
308/
2E225,
Indianapolis,
IN
46268.

067760
Cheminova
Inc.,
Oak
Hill
Park
1700
Route
23
­
Ste
210,
Wayne,
NJ
07470.

068156
Dintec
Agrichemicals,
9330
Zionsville
Rd,
Indianapolis,
IN
46268.

III.
What
is
the
Agency
Authority
for
Taking
This
Action?

Section
6(
f)(
1)
of
FIFRA
provides
that
a
registrant
of
a
pesticide
product
may
at
any
time
request
that
any
of
its
pesticide
registrations
be
amended
to
delete
one
or
more
uses.
The
Act
further
provides
that,
before
acting
on
the
request,
EPA
must
publish
a
notice
of
receipt
of
any
such
request
in
the
Federal
Register.
Thereafter,
the
Administrator
may
approve
such
a
request.

IV.
Procedures
for
Withdrawal
of
Request
Registrants
who
choose
to
withdraw
a
request
for
use
deletion
must
submit
such
withdrawal
in
writing
to
James
A.
Hollins,
at
the
address
under
FOR
FURTHER
INFORMATION
CONTACT,
postmarked
on
or
before
December
10,
2002.

V.
Provisions
for
Disposition
of
Existing
Stocks
The
Agency
has
authorized
the
registrants
to
sell
or
distribute
product
under
the
previously
approved
labeling
for
a
period
of
18
months
after
approval
of
the
revision,
unless
other
restrictions
have
been
imposed,
as
in
special
review
actions.

List
of
Subjects
Environmental
protection,
Pesticides
and
pests.

Dated:
May
29,
2002.
Linda
Vlier
Moos,
Acting
Director,
Information
Resources
and
Services
Division.
[FR
Doc.
02–
14997
Filed
6–
12–
02;
8:
45
a.
m.]

BILLING
CODE
6560–
50–
S
ENVIRONMENTAL
PROTECTION
AGENCY
[OPP–
2002–
0069;
FRL–
7177–
9]

Methodology
for
Lower
Toxicity
Pesticide
Chemicals;
Notice
of
Availability
AGENCY:
Environmental
Protection
Agency
(EPA).

ACTION:
Notice.
SUMMARY:
EPA
is
soliciting
comments
on
a
document
entitled
``
Methodology
for
Determining
the
Data
Needed
and
the
Types
of
Assessments
Necessary
to
Make
FFDCA
Section
408
Safety
Determinations
for
Lower
Toxicity
Pesticide
Chemicals.
''
Interested
parties
may
request
a
copy
of
the
Agency's
proposed
guidance
document
as
set
forth
in
Unit
IB
of
this
Notice.

DATES:
Comments,
identified
by
docket
ID
number
OPP–
2002–
0069,
must
be
received
on
or
before
September
11,
2002.

ADDRESSES:
Comments
may
be
submitted
by
mail,
electronically,
or
in
person.
Please
follow
the
detailed
instructions
for
each
method
as
provided
in
Unit
I.
of
the
SUPPLEMENTARY
INFORMATION.
To
ensure
proper
receipt
by
EPA,
it
is
imperative
that
you
identify
docket
ID
number
OPP–
2002–
0069
in
the
subject
line
on
the
first
page
of
your
response.

FOR
FURTHER
INFORMATION
CONTACT:
Kathryn
Boyle,
Registration
Division
(7505C),
Office
of
Pesticide
Programs,
Environmental
Protection
Agency,
1200
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40733
Federal
Register
/
Vol.
67,
No.
114
/
Thursday,
June
13,
2002
/
Notices
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460;
telephone
number:
703–
305–
6304;
fax
number:
703–
305–
0599;
e­
mail
address:
boyle.
kathryn@
epa.
gov.
SUPPLEMENTARY
INFORMATION:

I.
General
Information
A.
Does
this
Action
Apply
to
Me?
This
action
is
directed
to
the
public
in
general.
This
action
may,
however,
be
of
interest
to
those
persons
who
are
or
may
be
required
to
conduct
testing
of
chemical
substances
­
under
the
Federal
Food,
Drug,
and
Cosmetic
Act
(FFDCA),
or
the
Federal
Insecticide,
Fungicide,
and
Rodenticide
Act
(FIFRA).
Since
other
entities
may
also
be
interested,
the
Agency
has
not
attempted
to
describe
all
the
specific
entities
that
may
be
affected
by
this
action.
If
you
have
any
questions
regarding
the
applicability
of
this
action
to
a
particular
entity,
consult
the
person
listed
under
FOR
FURTHER
INFORMATION
CONTACT.

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

1.
Electronically.
You
may
obtain
electronic
copies
of
this
document,
and
certain
other
related
documents
that
might
be
available
electronically,
from
the
EPA
Internet
Home
Page
at
http://
www.
epa.
gov/.
To
access
this
document,
on
the
Home
Page
select
``
Laws
and
Regulations,
''
``
Regulations
and
Proposed
Rules,
''
and
then
look
up
the
entry
for
this
document
under
the
``
Federal
Register''—
Environmental
Documents.
You
can
also
go
directly
to
the
Federal
Register
listings
at
http://
www.
epa.
gov/
fedrgstr/.
2.
In
person.
The
Agency
has
established
an
official
record
for
this
action
under
docket
ID
number
OPP–
2002–
0069.
The
official
record
consists
of
the
documents
specifically
referenced
in
this
action,
any
public
comments
received
during
an
applicable
comment
period,
and
other
information
related
to
this
action,
including
any
information
claimed
as
Confidential
Business
Information
(CBI).
This
official
record
includes
the
documents
that
are
physically
located
in
the
docket,
as
well
as
the
documents
that
are
referenced
in
those
documents.
The
public
version
of
the
official
record
does
not
include
any
information
claimed
as
CBI.
The
public
version
of
the
official
record,
which
includes
printed,
paper
versions
of
any
electronic
comments
submitted
during
an
applicable
comment
period,
is
available
for
inspection
in
the
Public
Information
and
Records
Integrity
Branch
(PIRIB),
Rm.
119,
Crystal
Mall
#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
control
number
OPP–
2002–
0069
in
the
subject
line
on
the
first
page
of
your
response.
1.
By
mail.
Submit
your
comments
to:
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:
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
or
ASCII
file
format.
All
comments
in
electronic
form
must
be
identified
by
docket
ID
number
OPP–
2002–
0069.
Electronic
comments
may
also
be
filed
online
at
many
Federal
Depository
Libraries.

D.
How
Should
I
Handle
CBI
that
I
Want
to
Submit
to
the
Agency?
Do
not
submit
any
information
electronically
that
you
consider
to
be
CBI.
You
may
claim
information
that
you
submit
to
EPA
in
response
to
this
document
as
CBI
by
marking
any
part
or
all
of
that
information
as
CBI.
Information
so
marked
will
not
be
disclosed
except
in
accordance
with
procedures
set
forth
in
40
CFR
part
2.
In
addition
to
one
complete
version
of
the
comment
that
includes
any
information
claimed
as
CBI,
a
copy
of
the
comment
that
does
not
contain
the
information
claimed
as
CBI
must
be
submitted
for
inclusion
in
the
public
version
of
the
official
record.
Information
not
marked
confidential
will
be
included
in
the
public
version
of
the
official
record
without
prior
notice.
If
you
have
any
questions
about
CBI
or
the
procedures
for
claiming
CBI,
please
consult
the
person
listed
under
FOR
FURTHER
INFORMATION
CONTACT.

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?

The
Agency
is
announcing
the
availability
of
a
methodology
for
assessing
the
hazards
and
risks
of
lower
toxicity
pesticide
chemicals
for
public
comment
and
review.
This
paper
describes
how
lower
toxicity
pesticide
chemicals,
including
inert
ingredients,
would
be
evaluated
for
use
in
pesticide
products.
The
OPP
is
the
Office
within
the
Environmental
Protection
Agency
(EPA
or
the
Agency)
that
evaluates
pesticide
products.
OPP's
responsibilities
(all
of
which
could
be
affected
by
the
use
of
this
new
methodology)
include:
registration
of
new
active
ingredients,
reregistration
of
older
active
ingredients,
reassessment
of
both
tolerances
and
tolerances
exemptions,
approval
of
new
inert
ingredients,
and
list
reclassification
of
inert
ingredients.
Development
of
this
methodology
began
as
a
result
of
OPP's
need
to
(1)
develop
a
new
methodology
for
assessing
inert
ingredients
to
comply
with
the
requirements
of
the
Food
Quality
Protection
Act
(FQPA)
of
1996
which
amended
both
the
FFDCA
and
the
FIFRA,
and
(2)
to
improve
the
efficiency
and
effectiveness
of
the
inert
review
process.
In
many
instances,
a
chemical
can
be
used
as
an
inert
ingredient
in
some
pesticide
products
and
as
an
active
ingredient
in
other
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/
Vol.
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114
/
Thursday,
June
13,
2002
/
Notices
pesticide
products.
Since
FFDCA
section
408
makes
no
distinction
between
active
and
inert
ingredients
of
a
pesticide
product,
EPA
may
use
this
tiered
data
screening
methodology
when
evaluating
any
pesticide
chemical
of
apparent
low
or
low/
moderate
toxicity,
regardless
of
whether
it
might
be
characterized
as
an
active
or
inert
ingredient.
At
this
time,
EPA
has
completed
review
of
two
tolerance
exemption
petitions
and
over
200
tolerance
reassessments
for
low
or
low/
moderate
toxicity
chemicals
using
essentially
the
process
described
in
this
paper.
More
reviews
are
underway.
Based
on
these
experiences,
OPP
intends
to
continue
its
chemical­
by­
chemical
reviews
of
pesticide
chemicals
according
to
the
process
described
herein
for
the
foreseeable
future.
However,
EPA
remains
interested
in
further
improvements
in
the
efficiency
and
reliability
of
its
process,
and
therefore
welcomes
comments
from
interested
persons.
After
evaluating
several
alternatives,
OPP
believes
that
a
screening
methodology
is
the
most
appropriate
way
to
handle
the
variety
of
hazard
and
exposure
issues
posed
by
inert
ingredients.
This
screening
methodology
will
allow
OPP
to
make
decisions
in
a
streamlined
manner
for
low
or
low/
moderate
toxicity
chemical
substances.
By
being
able
to
quickly
review
and
approve
the
use
of
these
chemical
substances,
more
low
or
low/
moderate
toxicity
chemical
substances
will
be
available
for
use
in
pesticide
products.
OPP
will
also
be
able
to
focus
its
resources
on
those
chemical
substances
of
potentially
higher
toxicity
requiring
in­
depth
evaluation.
OPP
has
incorporated
elements
of
a
tiered
data
approach
into
this
methodology.
For
these
lower
toxicity
chemicals,
OPP
would
use
existing
information
on
the
hazard
potential
(both
human
health
and
ecological)
of
a
chemical
substance
as
the
basis
for
deciding
if
additional
data
are
needed
to
support
the
use
of
the
chemical.
The
hazard
potential
­
the
toxicity
­
is
the
driving
force
in
determining
tier
placement.
Chemical
substances
that
are
of
low
or
low/
moderate
toxicity
may
be
appropriately
placed
in
a
lower
tier,
with
fewer
data
needed
to
make
the
safety
finding.
Chemicals
of
higher
toxicity
that
can
not
be
appropriately
addressed
in
the
lower
tiers
would
be
evaluated
in
a
manner
substantially
similar
to
that
of
an
active
ingredient.
The
process
described
in
this
paper
has
three
tiers,
with
the
first
tier
being
subdivided
into
Tiers
1a
and
1b.
The
process
begins
with
a
preliminary
Tier
determination
that
is
based
on
widely
available
information
on
chemical
families
and
categories
which
includes
the
hazards
associated
with
these
chemicals.
Later
as
the
Agency
begins
to
review
chemical­
specific
or
surrogate
information
in
the
open
literature,
the
preliminary
Tier
determination
may
be
revised.
The
methodology
is
intended
to
provide
guidance
to
EPA
personnel
and
decision­
makers,
and
to
pesticide
registrants.
The
policies
and
process
described
in
this
methodology
are
not
binding
on
either
EPA
or
pesticide
registrants,
and
EPA
may
modify
or
disregard
the
process
described
herein
where
circumstances
warrant
and
without
prior
notice.
Likewise,
pesticide
registrants
may
assert
that
this
process
is
not
appropriate
generally
or
not
applicable
to
a
specific
pesticide
chemical
or
situation.

III.
Questions/
Issues
for
Public
Comment
 
A
significant
challenge
faced
in
developing
a
methodology
for
a
comprehensive
assessment
program
for
chemicals
of
low
or
low/
moderate
toxicity
is
determining
the
most
appropriate
procedure
for
evaluating
such
a
diverse
group
of
substances,
with
a
very
wide
range
of
physical/
chemical
characteristics.
Does
the
screening
approach
as
described
in
the
methodology
paper
reflect
a
workable,
logical
approach?
 
It
is
likely
that
a
large
percentage
of
inert
ingredients
are
not
likely
to
be
of
significant
toxicological
concern.
The
Agency's
expectation
is
that
on
the
order
of
50%
of
inert
ingredients
would
be
of
low
or
low/
moderate
risk.
At
the
same
time,
EPA
must
be
able
to
identify
problematic
inert
ingredients
and
then
have
the
resources
to
take
appropriate
action
to
analyze
and
reduce
these
risks.
Would
this
methodology
give
the
Agency
the
necessary
flexibility
while
allowing
for
an
effficient
and
productive
process?
 
Several
sources
for
credible,
scientifically
valid
chemical
information
are
given
in
the
policy
paper.
What
other
possible
sources
of
readily
available
credible,
scientifically
valid
chemical
information
are
available?
 
The
Agency
has
described,
as
best
possible
at
this
beginning
stage,
the
process
that
would
be
used
to
evaluate
inert
ingredients
as
well
as
the
role
played
by
a
petitioner
for
a
tolerance
or
tolerance
exemption
or
those
seeking
to
support
a
chemical
during
tolerance
reassessment.
What
additional
information
would
be
helpful
to
the
regulated
community?
List
of
Subjects
Environmental
protection,
Administrative
practice
and
procedure,
Agricultural
commodities,
Pesticides
and
pests.

Dated:
June
7,
2002.
Marcia
E.
Mulkey,
Director,
Office
of
Pesticide
Programs.
[FR
Doc.
02–
14996
Filed
6–
12–
02;
8:
45
am]

BILLING
CODE
6560–
50–
S
ENVIRONMENTAL
PROTECTION
AGENCY
[FRL–
7230–
6]

Persistent
Organic
Pollutants
AGENCY:
Environmental
Protection
Agency
(EPA).

ACTION:
Notice
of
availability.

SUMMARY:
This
notice
announces
the
availability
of
a
final
technical
report
titled,
The
Foundation
for
Global
Action
on
Persistent
Organic
Pollutants:
A
United
States
Perspective
(EPA/
600/
P–
01/
003F,
March
2002),
which
was
prepared
by
the
Office
of
Research
and
Development's
(ORD)
National
Center
for
Environmental
Assessment
(NCEA).
The
purpose
of
this
report
is
to
inform
decision
makers,
general
academia,
and
the
public
on
the
scientific
foundation
and
relevance
to
the
United
States
of
the
Stockholm
Convention
on
Persistent
Organic
Pollutants
(POPs).

ADDRESSES:
The
document
is
available
electronically
on
NCEA's
Web
site
at
www.
epa.
gov/
ncea,
under
the
What's
New
or
Publications
menus.
The
CD–
ROM
version
and
a
limited
number
of
paper
copies
will
be
available
shortly
from
the
EPA's
National
Service
Center
for
Environmental
Publications
(NSCEP),
PO
Box
42419,
Cincinnati,
OH
45242;
telephone:
1–
800–
490–
9198
or
513–
489–
8190;
facsimile:
513–
489–
8695.
Please
provide
your
name
and
mailing
address
and
the
title
and
EPA
number
of
the
requested
publication.

FOR
FURTHER
INFORMATION
CONTACT:
For
further
information
on
The
Foundation
for
Global
Action
on
Persistent
Organic
Pollutants:
A
United
States
Perspective,
please
contact
Dr.
Bruce
Rodan,
National
Center
for
Environmental
Assessment
(8601D),
U.
S.
Environmental
Protection
Agency,
1200
Pennsylvania
Avenue,
NW.,
Washington,
DC
20460;
Telephone:
202–
564–
3329;
facsimile:
(202)
565–
0090;
e­
mail:
rodan.
bruce@
epa.
gov;
or
the
Technical
Information
Staff,
National
Center
for
Environmental
Assessment/
Washington
Office
(8623D),
U.
S.
Environmental
Protection
Agency,

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