Document ID: EPA-HQ-OPP-2002-0231-0003
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2003-01-30T05:00Z

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PR
Notice
97­
3
Registering
Pesticides
Pesticide­
Producing
Establishments
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Issues
Adverse
Effects
Reporting
Storage
&
Disposal
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&
Canceled
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Tolerances
Registration
Information
Sources
Fax­
On­
Demand
Telephone:
(
202)
401­
0527
Item:
6101
September
4,
1997
Pesticide
Registration
(
PR)
Notice
97­
3
NOTICE
TO
MANUFACTURERS,
FORMULATORS,
PRODUCERS
AND
REGISTRANTS
OF
PESTICIDE
PRODUCTS
ATTENTION:
Persons
Responsible
for
Registration
of
Pesticide
Product
SUBJECT:
Guidelines
for
Expedited
Review
of
Conventional
Pesticide
under
the
Reduced­
Risk
Initiative
and
for
Biological
Pesticides
I.
PURPOSE
The
Federal
Insecticide,
Fungicide,
and
Rodenticide
Act
(
FIFRA)
as
amended
by
the
Food
Quality
Protection
Act
of
1996
(
FQPA)
requires
the
Environmental
Protection
Agency
(
EPA)
to
develop
procedures
and
guidelin
for
expedited
review
of
any
pesticide.
These
procedures
and
guidelines
must
be
in
place
within
one
year
after
the
date
of
enactment
of
the
FQPA
(
by
August
3,
1997).
EPA
has
already
established
a
Reduced
Risk
Initiat
for
conventional
pesticides,
has
formed
the
Biopesticides
and
Pollution
Prevention
Division
to
review
biological
pesticides
and
has
established
Antimicrobial
Division
to
review
antimicrobial
pesticides.
The
purpose
this
PR
Notice
is
to
provide
the
process
and
criteria
to
guide
applicant
in
developing
their
submissions
to
these
programs.

This
PR
Notice
supersedes
the
reduced­
risk
criteria
published
in
Federal
Register
Notices
57
FR
32140,
July
20,
1992
and
58
FR
5854,
Janu
22,
1993
and
PR
Notice
93­
9,
July
21,
1993.
In
addition,
it
defines
the
types
of
pesticide
products
reviewed
by
the
Biopesticides
and
Pollution
Prevention
Division
and
describes
how
an
applicant
can
apply
for
biochemical
pesticide
classification.

The
goal
of
the
Reduced­
Risk
Pesticide
Initiative
and
the
Biopesticides
and
Pollution
Prevention
Division
is
to
encourage
the
development,
registration
and
use
of
lower­
risk
pesticide
products
which
would
result
in
reduced
risks
to
human
health
and
the
environment
when
compared
to
existing
alternatives.
The
major
incentive
which
EPA
offers
for
these
pesticides
is
expedited
registration
review.
The
major
goal
o
the
Antimicrobial
Division
is
to
provide
expedited
review
of
all
types
o
antimicrobial
registration
actions.

II.
APPLICABILITY
This
notice
applies
to
all
applicants
for
initial
registration
and
amended
registration
for
conventional
pesticides,
as
described
more
full
in
Sections
IV­
X,
and
for
biological
pesticides,
as
described
in
Section
XI.
The
term
"
conventional
pesticides"
as
used
in
this
notice
includes
pesticides
other
than
biological
pesticides
and
antimicrobial
pesticides
(
as
defined
in
FQPA).
Since
certain
pesticide
products,
such
as
wood
preservatives
and
antimicrobials,
are
not
defined
as
antimicrobial
produ
in
FQPA
but
are
handled
in
the
Antimicrobial
Division,
for
the
purposes
this
notice
they
are
considered
conventional
pesticides.

III.
EFFECTIVE
DATE
This
PR
Notice
is
effective
immediately.

IV.
BACKGROUND
ON
THE
REDUCED­
RISK
INITIATIVE
In
July
1992,
the
Office
of
Pesticide
Programs
(
OPP)
published
a
Federal
Register
notice
announcing
the
need
for
incentives
for
the
development
and
registration
of
reduced­
risk
pesticides.
In
a
subsequen
Federal
Register
notice
(
January
1993)
OPP
announced
the
initiation
of
t
Reduced­
Risk
effort,
and
in
July
1993
OPP
published
PR
Notice
93­
9
which
provided
interim
reduced­
risk
criteria
and
guidance
for
submissions.

Since
July
1993,
applicants
have
sent
thirty­
nine
new
chemical
or
n
use
submissions
to
OPP
for
consideration
as
reduced­
risk
pesticides.
Of
the
thirty­
nine,
twenty­
two
have
been
accepted
by
OPP
as
reduced­
risk
candidates;
and
sixteen
have
been
rejected.
Of
the
twenty­
two
accepted
reduced­
risk
submissions,
fourteen
have
been
registered.
The
following
a
list
of
the
registered
pesticides
by
accepted
common
names
(
if
availab
and
their
trade
name
(
in
parenthesis):

(
1)
Hexaflumuron
(
Recruit)
­
below
ground
bait
station
termiticide
(
2)
Flumiclorac­
pentyl
(
Resource)
­
post
emergent
herbicide
on
cor
soybeans
(
3)
Methyl
Anthranilate
(
Rejex­
It)
­
bird
repellent
on
cherries,
grapes,
blueberries,
forestry
(
4)
Tebufenozide
(
Confirm)
­
insecticide
on
walnuts
(
5)
Hymexazol
(
Tachigaren)
­
fungicide
seed
treatment
on
sugar
bee
(
6)
Fludioxonil
(
Maxim)
­
fungicide
seed
treatment
on
corn,
sorghu
(
7)
(
Cadre)
­
herbicide
on
peanuts
(
8)
(
Mefenoxam)
­
fungicide
on
multiple
crops
(
9)
Spinosad
(
Spinosad)
­
insecticide
on
cotton
(
10)
Azoxystrobin
(
Heritage)
­
fungicide
on
turf
(
11)
Alpha­
Metolachlor
(
CGA
77102)
­
herbicide
on
multiple
crops.

(
12)
Hexaflumuron
(
Recruit)
­
above
ground
bait
station
new
use
termiticide
(
13)
Imazamox
(
Raptor)
­
herbicide
on
soybeans
(
14)
Azoxystrobin
(
Heritage)
­
fungicide
on
grapes,
bananas,
peache
tomatoes,
pecans
and
peanuts
The
major
advantage
for
reduced­
risk
pesticides
is
expedited
registration
review.
For
FY95
and
FY96
(
prior
to
the
passage
of
FQPA
in
August
1996)
the
average
total
time
required
to
register
a
new
conventio
pesticide
was
thirty­
eight
months.
For
reduced­
risk
pesticides
the
aver
total
time
for
registration
was
only
fourteen
months.
Since
passage
of
FQPA
three
new
AI,
reduced­
risk
pesticides
were
registered
in
seventeen,
eighteen
and
seventeen
months,
somewhat
longer
than
the
pre­
FQPA
average
but
still
substantially
shorter
than
the
conventional
pesticide
times.
faster
registration
times
reflect,
in
part,
the
expedited
review
status
granted
reduced­
risk
actions.
Not
only
is
the
initial
submission
grante
high
review
priority
but
also
any
resubmission
that
may
be
necessary.
If
the
applicant
is
simultaneously
seeking
registration
in
Canada,
if
the
application
has
been
determined
by
Canada
to
be
complete,
the
reduced­
risk
action
can
also
qualify
for
work­
sharing
between
the
two
countries.
While
this
work­
sharing
program
is
still
in
the
"
pilot"
stag
it
could
result
in
further
reduced
review
times
and
greater
harmonizatio
V.
CHARACTERISTICS
OF
ACCEPTABLE
AND
UNACCEPTABLE
SUBMISSIONS
FOR
THE
REDUCED­
RISK
INITIATIVE
OPP
has
assessed
fourteen
of
the
twenty­
two
reviews
conducted
by
th
Reduced
Risk
Committee
of
submissions
that
were
determined
to
be
reduced­
risk.
Those
factors
that
most
significantly
contributed
to
EPA'
decision
to
grant
reduced
risk
status
are
summarized
below
in
descending
order:

o
human
health
effects
­
very
low
mammalian
toxicity
­
toxicity
generally
lower
than
alternatives
(
10­
100X)
­
displaces
chemicals
that
pose
potential
human
health
concerns
[
e.
g.,
organophosphates
(
OPs),
probable
carcinogens
(
B2s)]
­
reduces
exposure
to
mixers,
loaders,
applicators
and
reen
workers
o
non­
target
organism
effects
(
birds)

­
very
low
toxicity
to
birds
­
very
low
toxicity
to
honeybees
­
significantly
less
toxicity/
risk
to
birds
than
alternativ
­
not
harmful
to
beneficial
insects,
highly
selective
pest
impacts
o
non­
target
organism
effects
(
fish)

­
very
low
toxicity
to
fish
­
less
toxicity/
risk
to
fish
than
alternatives
­
potential
toxicity/
risk
to
fish
mitigatable
­
similar
toxicity
to
fish
as
alternatives
but
significantl
less
exposure
o
groundwater
(
GW)

­
low
potential
for
GW
contamination
­
low
drift,
runoff
potential
­
runoff
mitigatable
o
lower
use
rates
than
alternatives,
fewer
applications
o
low
pest
resistance
potential
(
i.
e.,
new
mode
of
action)

o
highly
compatible
with
IPM
o
efficacy.

OPP
has
also
assessed
eleven
of
the
sixteen
reviews
conducted
by
th
Reduced
Risk
Committee
of
submissions
that
were
determined
not
to
be
reduced­
risk.
Those
factors
that
most
significantly
contributed
to
an
unacceptable
decision
by
the
committee
are
summarized
below
in
descendin
order:

o
human
health
effects
­
inadequate/
inappropriate
comparisons
with
alternatives
­
inadequate
documentation
of
effects
­
human
health
risk
reduction
case
weak
­
risk
reduction
case
inadequate
when
compared
to
alternatives
o
non­
target
organism
effects
(
birds
and
fish)

­
toxic
to
birds
­
toxic
to
fish
­
risk
reduction
case
inadequate
when
compared
to
alternatives
o
potential
GW
problems
o
unlikely
to
displace
higher
risk
alternatives
o
lack
of
efficacy
data
o
phytotoxicity.

This
survey
of
past
decisions
should
assist
future
applicants
in
preparing
their
submissions.

VI.
PROCEDURES
AND
GUIDELINES
FOR
EXPEDITED
REVIEW
OF
CONVENTIONAL
AND
ANTIMICROBIAL
PESTICIDES
A.
Background
In
general,
FIFRA
section
3(
c)(
3)(
A)
requires
EPA
after
receipt
of
application
for
registration
of
a
pesticide
"
as
expeditiously
as
possibl
either
to
register
it
or
to
notify
the
applicant
that
the
application
do
not
comply
with
the
Act.
FIFRA
also
establishes
expedited
review
procedures
for
a
variety
of
Agency
activities
associated
with
the
registration
of
pesticides,
including
expedited
review
for
certain
end­
u
pesticides
that
are
identical
or
substantially
similar
to
currently
registered
pesticides
("
me
too"
registrations)
as
provided
in
FIFRA
sect
3(
c)(
3)(
B)(
II),
and
for
antimicrobial
pesticides
as
provided
for
in
FIFR
section
3(
h)(
2).
EPA
also
has
several
programs
to
expedite
the
registration
process
for
biological
pesticides
by
the
Biopesticides
and
Pollution
Prevention
Division,
antimicrobial
pesticides
by
the
Antimicrobial
Division
and
fast
track
procedures
to
expedite
the
registration
of
certain
amendments
to
existing
conventional
pesticide
registrations.
As
a
result
of
these
programs,
EPA
is
already
expediting
many
pesticide
applications
for
registration.

FIFRA
section
3(
c)(
10)
establishes
an
expedited
review
for
applications
for
registration
and
amendments
to
registrations
for
pesticides
that
"
may
reasonably
be
expected
to
accomplish
one
or
more
of
the
following:

(
i)
Reduce
the
risks
of
pesticides
to
human
health.

(
ii)
Reduce
the
risks
of
pesticides
to
nontarget
organisms.

(
iii)
Reduce
the
potential
for
contamination
of
groundwater,
surface
water
or
other
valued
environmental
resources.

(
iv)
Broaden
the
adoption
of
integrated
pest
management
strategies,
or
make
such
strategies
more
available
or
more
effective."

The
statute
does
not
establish
deadlines
for
review
of
registration
applications
or
amendments
that
meet
the
above
criteria.
Section
3(
c)(
1
however,
requires
EPA
to
notify
the
applicant
whether
the
application
fo
expedited
review
is
complete
no
later
than
30
days
after
receipt
of
the
application.

B.
Procedures
EPA
intends
to
establish
a
two­
step
procedure
for
expedited
review
pursuant
to
FIFRA
section
3(
c)(
10).
1.
Step
One
­
Application.
For
step
1,
the
Agency
will
determine
whether
an
application
for
registration
or
amended
registratio
qualifies
for
expedited
review
based
upon
whether
use
of
the
pesticide
proposed
by
the
application
may
reasonably
be
expected
to
accomplish
one
more
of
the
criteria
listed
in
Section
VI.
A.
above.

To
initiate
the
process,
the
applicant
must
submit
an
application
f
expedited
review
demonstrating
how
the
use
of
the
pesticide
may
reasonab
be
expected
to
accomplish
one
or
more
of
the
criteria
listed
in
section
VI.
A.
above.
The
applicant
also
must
submit
a
reduced­
risk
rationale
pursuant
to
the
guidelines
and
procedures
specified
in
sections
VII
­
IX
this
notice.
The
step
1
rationale
may
be
a
sentence
or
a
paragraph
in
t
reduced­
risk
rationale
summary
as
long
as
the
claims
are
documented
elsewhere
in
the
reduced­
risk
rationale.

Certain
types
of
pesticide
applications
for
registration
and
amende
registration
already
receive
expedited
review
pursuant
to
existing
Agenc
programs.
Because
the
Agency
is
already
expediting
review
of
these
registrations,
it
is
not
necessary
to
include
them
in
the
review
program
established
pursuant
to
FIFRA
section
3(
c)(
10).
Applications
that
alrea
receive
expedited
review
include
applications
for
registration
or
amende
registration
for
biological
or
antimicrobial
pesticides,
"
me­
too"
applications
for
registration
or
amended
registrations
of
end­
use
pesticides
under
FIFRA
section
3(
c)(
3)(
B)(
I)
that
are
identical
or
substantially
similar
to
other
EPA
registered
pesticide
products,
and
applications
for
certain
pesticides
under
FIFRA
section
3(
c)(
3)(
B)(
II).

The
FQPA
amendments
require
EPA
to
make
expedited
decisions
on
antimicrobial
pesticides
as
defined
in
FIFRA
section
2(
mm).
Specificall
FIFRA
section
3(
h)(
2)
establishes
goals
for
the
time
periods
during
whic
EPA
must
review
different
types
of
applications
for
antimicrobials
cover
by
the
statutory
definition
and
make
decisions
whether
to
approve
or
den
the
applications.
Generally,
these
review
and
decision
deadlines
are
30
to
60%
shorter
than
historic
Agency
performance
in
processing
such
applications.

While
FIFRA
antimicrobial
review
deadlines
do
not
become
legally
binding
until
May
1998,
as
a
matter
of
policy,
the
Agency
has
committed
and,
in
fact,
is
meeting
the
goals
specified
in
FIFRA
section
3(
h)(
2)
as
well
as
the
expedited
deadlines
already
mandated
in
FIFRA
section
3(
c)(
3)(
B).
For
every
application
received
by
the
Agency
since
November
1996,
the
Agency
has
made
a
registration
decision
within
the
review
peri
provided
by
the
statute.
EPA
will
continue
to
expedite
review
of
applications
for
registrations
and
amendments
to
registrations
for
antimicrobial
pesticides
pursuant
to
its
commitment.

The
Agency's
improved
performance
in
review
of
antimicrobials
is
th
result
of
several
new
initiatives.
First,
EPA
has
established
within
th
Office
of
Pesticide
Programs
a
new
Antimicrobials
Division
(
AD)
that
is
responsible
for
all
regulatory
decisions
relating
to
antimicrobial
and
related
pesticides.
In
addition
to
regulatory
staff,
the
new
AD
organization
includes
scientific
personnel
capable
of
performing
most
of
the
analyses
needed
to
make
a
registration
decision.
Thus,
AD
is
capabl
of
providing
"
one­
stop
shopping"
for
registration
decisions.
Second,
th
new
AD
management
team
has
instituted
a
number
of
process
improvements,
including
a
dedicated
expedited
review
team
of
"
me­
too"
applications,
th
have
resulted
in
a
significantly
improved
performance.

Thus,
because
EPA's
current
organizational
and
resource
allocations
and
process
improvements
are
providing
expedited
review
for
antimicrobia
all
types
of
applications
for
antimicrobial
pesticides
(
as
defined
in
FQ
will
be
outside
the
scope
of
this
PR
Notice.

What
types
of
applications
for
expedited
review
will
the
Agency
accept?
An
application
for
expedited
review
may
be
submitted
only
for
t
following
types
of
actions:
(
a)
an
application
to
register
a
conventional
pesticide
that
conta
an
active
ingredient
not
contained
in
any
currently
registered
pesticide,
provided
the
pesticide
is
not
a
biopesticide
or
an
antimicrobial
pesticide
(
as
defined
in
FQPA).
[
See
sections
VI
through
IX
for
reduced­
risk
rationale
guidelines];
or
(
b)
an
application
to
amend
the
registration
of
a
currently
registered
conventional
pesticide
for
an
additional
new
use,
provided
the
pesticide
is
not
a
biopesticide
or
an
antimicrobi
pesticide
(
as
defined
in
FQPA).
[
See
sections
VII
through
IX
f
reduced­
risk
rationale
guidelines];
or
a
non­
fast­
track
application
for
registration
of
a
new
formulation
provided
the
pesticide
is
not
a
biopesticide
or
an
antimicrobial
pesticide
(
as
defined
in
FQPA).
[
See
section
X
f
expedited
review
rationale
guidelines].

2.
Step
2
­
Reduced­
Risk
Determination
If
an
application
for
expedited
review
qualifies
under
step
1,
the
Agency
will
expedite
the
review
of
the
reduced­
risk
rationale
presented
by
the
applicant
to
determine
whether
the
pesticide
qualifies
under
the
reduced­
risk
criter
described
in
sections
VII
and
X
below.
The
Agency's
Reduced­
Risk
Commit
will
expedite
the
review
of
the
reduced­
risk
rationale
and
complete
its
review
within
thirty
days
of
receipt
of
a
complete
reduced­
risk
rational
If
the
Agency
decides
that
a
pesticide
qualifies
for
reduced­
risk
status
then
it
will
further
expedite
review
of
the
remainder
of
the
application
for
registration
or
amended
registration
as
described
in
section
IV
of
t
notice.

If
the
Agency
denies
a
submission
reduced­
risk
status,
applica
will
be
given
only
one
opportunity
to
rebut
this
decision,
and
the
applicant
will
have
four
weeks
to
resubmit
their
rebuttal.
Due
to
limit
program
resources,
the
Agency
can
only
allow
one
opportunity
to
rebut
a
decision.
Pesticides
that
EPA
determines
do
not
qualify
for
reduced­
risk
status
during
step
2
will
be
processed
in
accordance
with
existing
Agenc
procedures.

VII.
GUIDELINES
FOR
REDUCED
RISK
RATIONALES
While
participation
in
the
reduced­
risk
pesticides
program
is
voluntary,
those
who
elect
to
participate
must
fully
address
all
of
the
following
areas:
(
a)
executive
summary,
(
b)
human
health
effects;
(
c)
environmental
fate
and
effects;
(
d)
other
hazards;
(
e)
risk
discussion
(
pest
resistance
and
management
(
e.
g.,
IPM);
and
(
g)
comparative
performance,
(
h)
other
information
and
how
application
complies
with
FQP
The
Agency
will
consider
all
of
these
areas
in
determining
the
acceptability
of
these
applications.
However,
these
may
not
be
the
exclusive
factors
in
all
cases.
If
an
applicant
identifies
additional
criteria
that
substantiate
the
argument
that
their
product
is
indeed
a
reduced­
risk
pesticide,
then
EPA
invites
the
applicant
to
submit
a
rationale
with
any
supporting
data
to
verify
such
a
claim.
The
Agency
w
consider
this
additional
information.

An
applicant's
documentation
must
contain
both
a
discussion
of
the
inherent
reduced­
risk
properties
of
their
product,
as
well
as
a
comparis
of
those
properties
with
the
properties
of
the
commonly­
used
alternative
where
appropriate.
Comparisons
must
be
made
to
conventional
chemical
pesticides,
antimicrobial
pesticides,
biological
pesticides,
and
cultura
practices
currently
being
used
for
pest
control
at
the
same
use
site(
s)
for
the
same
pest(
s).

Please
note
that
the
Agency
does
not
expect
the
applicant
to
perfor
any
additional
testing
to
derive
the
data
necessary
to
develop
rationale
for
the
Reduced­
Risk
Program.
The
applicant
must
summarize
all
data
in
applicant's
possession
or
control
or
available
through
the
open
literatu
for
the
product
being
submitted
to
the
Agency.
If
data
addressing
one
o
the
stated
factors
has
been
developed,
but
is
not
required
for
registrat
of
the
pesticide
in
the
United
States,
the
applicant
must
provide
a
summ
of
these
data
as
part
of
the
Reduced­
Risk
Rationale.
If
any
of
the
required
information
is
not
known,
that
fact
must
be
noted
in
the
rationale.

If
the
rationale
does
not
include
a
discussion
of
each
of
these
factors
or
provide
reasoning
as
to
why
the
factor
should
not
be
consider
in
the
Agency's
decision,
OPP
will
consider
the
rationale
to
be
incomple
and
not
responsive
to
this
PR
Notice.
However,
if
the
applicant
believe
that
the
factor
does
not
apply
to
the
new
pesticide,
the
registrant
must
provide
a
short
rationale
describing
this
reasoning.

In
situations
where
the
Agency
has
already
reviewed
data
on
the
act
ingredient,
the
applicant
should
use
the
Agency's
review
to
address
the
relevant
factor(
s).
Applicants
must
also
provide
Master
Record
Identification
(
MRID)
numbers
for
each
study,
where
appropriate.

A.
Executive
Summary.
Provide
an
executive
summary
that
addresse
the
following
considerations:

1.
Chemical
Name.

2.
Chemical
Abstracts
Service
Registry
Number.

3.
Chemical
Structure.

4.
Chemical
Class
or
Family
Name
of
the
Active
Ingredient.

5.
Mode/
Mechanism
of
Pesticidal
Action
for
the
Active
Ingredient
(
if
known).

6.
Proposed
Use
Pattern
(
including
site(
s)
of
application
an
pest(
s)
controlled),
Application
Methods,
Application
Rat
Frequency
of
Application,
and
Product
Formulation
Percentages.
Also
indicate
whether
the
new
chemical
wil
be
used
in
combination
with
other
registered
pesticides.

7.
Brief
Overview
Summary
of
the
Health,
Ecological
and
Environmental
Fate
Effects.

8.
Tier
1
statement
stating
which
of
the
four
FQPA
criteria
being
met
by
this
application.

9.
Reduced­
Risk
Statement,
articulating
the
specific
factors
that
lead
the
applicant
to
the
conclusion
that
the
active
ingredient
offers
the
opportunity
for
risk
reduction.

10.
Data
Matrix,
providing
tabular
information
on
all
data
available
for
the
active
ingredient.
The
table
should
include
the
guideline
reference
number,
the
study
title,
MRID
number
(
if
available),
outcome
of
the
Agency's
evaluation
(
i.
e.,
in
review,
acceptable,
supplemental,
da
waived,
etc.),
and
date
of
the
Agency's
review
(
if
applicable).

B.
Human
Health.
Clearly
identify
the
portion
of
the
rationale
which
addresses
the
potential
effects
of
the
active
ingredient
on
human
health.
When
specifying
the
dose
levels
used
in
the
toxicity
studies,
present
the
no­
observable­
effects
level
(
NOEL)
and
the
lowest­
observable­
effects
level
(
LOEL).
Doses
need
to
be
specified
in
terms
of
mg/
kg/
day.
Also,
describe
qualitatively
and
quantitatively
the
array
of
effects
at
all
dose
levels
tested.
In
the
format
described
in
Part
IX
of
this
PR
Notice,
address
each
of
the
following
aspects
of
the
active
ingredient
and
its
use:
1.
Acute
Toxicity
of
the
active
ingredient
and
the
formulations.
Provide
the
toxicity
category
for
each
of
acute
toxicity
studies
conducted
on
the
active
ingredient
and
the
formulated
products.

2.
Reproductive,
Developmental,
Mutagenic
and
Neurotoxic
Properties
of
the
active
ingredient.

3.
Oncogenic
and
Other
Subchronic
and
Chronic
Effects
of
the
active
ingredient.

4.
Toxicity
of
Mammalian
and
Plant
Metabolites.

C.
Environmental
Fate
and
Effects.
Clearly
identify
the
portion
the
rationale
which
addresses
the
potential
ecological
effects
of
the
active
ingredient
and
its
environmental
fate.
The
discussion
should
als
address
potential
environmental
degradates
or
metabolites
of
the
active
ingredient.
Address
each
of
the
following
aspects
of
the
active
ingredients
and
its
use:

1.
Mammalian
Acute
Toxicity
2.
Avian
Acute
and
Subacute
Toxicity
3.
Avian
Reproductive
Toxicity
4.
Fish
Acute
and
Chronic
Toxicity
5.
Aquatic
Invertebrate
Toxicity
6.
Honeybee
Acute
Contact
Toxicity
7.
Effects
on
Terrestrial
Plant
Growth
8.
Effects
on
Aquatic
Plant
Growth
9.
Potential
Exposure
to
Non­
target
Organisms
10.
Environmental
Persistence
(
Soil
and
Water)

11.
Mobility
in
Soil
and
Water
12.
Transport
in
Air
(
Spray
Drift
and
Volatility)

13.
Bioaccumulation
as
Indicated
by
the
Octanol/
Water
Partiti
Coefficient
D.
Other
Hazards.
Clearly
identify
the
portion
of
the
rationale
which
addresses
other
potential
human
health
and
environmental
hazards
produced
by
the
following:

1.
Potential
to
Deplete
Stratospheric
Ozone
thus
increasing
ultraviolet
radiation.

2.
Potential
to
Present
a
Hazard
through
Storage,
Transportation,
Mixing,
Use
or
Disposal
based
on
its
physical
or
chemical
characteristics:

a.
stability
b.
flammability
c.
corrosion
characteristics
d.
explodability
e.
oxidizing
or
reducing
action
f.
storage
stability
3.
Potential
to
Affect
Endangered
and/
or
Threatened
Plant
an
Animal
Species
as
designated
under
the
Endangered
Species
Act.

E.
Risk
Discussion.
Clearly
identify
the
portion
of
the
rational
which
addresses
the
following
items:

1.
Discuss
the
information
which
supports
the
claims
that
th
active
ingredient
presents
reduced
toxicity,
reduced
exposure
to
humans
or
non­
target
organisms,
and/
or
reduce
environmental
burden.
When
discussing
the
ecological
lev
of
concern
(
LOCs),
present
the
methods
used
to
derive
the
and
provide
interpretations
of
what
the
LOCs
mean.

2.
Where
alternative,
registered
pesticides
or
pest
control
practices
exist,
make
a
quantitative
and/
or
qualitative
comparison
between
the
risks
posed
by
the
active
ingredie
under
consideration
and
all
the
other
pesticides
commonly
used,
and/
or
the
other
current
pest
control
practices.

3.
The
comparisons
with
alternative
technology
should
also
include
biological
pesticides
as
well
as
cultural
and
mechanical
pest
management
practices.

F.
Pest
Resistance
and
Management.
Clearly
identify
the
portion
the
rationale
which
addresses
the
following
items:

1.
Describe
how
the
active
ingredient
addresses
the
developm
of
pest
resistance,
either
to
the
active
ingredient
itsel
or
to
existing
pesticides
registered
for
the
same
use.

2.
Discuss
the
suitability
of
the
active
ingredient
for
use
or
encouraging
the
adoption
of,
Integrated
Pest
Managemen
(
IPM)
programs.
This
discussion
should
include
informati
on
the
effects
of
the
pesticide
on
natural
predators,
parasites
and
pathogens
of
each
target
pest,
if
such
information
is
known.
The
degree
of
risk
and/
or
usage
reduction
to
be
achieved
by
the
IPM
program
must
also
be
addressed.

G.
Comparative
Performance
Data
(
efficacy
data).
These
data
are
important
to
assure
that
risk
reduction
has
a
reasonable
opportunity
to
accomplished
by
adoption
of
the
new
pesticide
by
growers.

1.
It
is
desirable
to
have
summaries
of
comparative
performa
data
in
which
the
performance
of
the
candidate
pesticide
compared
to
that
of
alternative
control
measures
under
actual­
use
or
simulated
actual­
use
conditions.

2.
Summaries
of
the
available
efficacy
data
if
comparative
performance
data
are
not
available.

Summaries
should
include
statistical
analysis
of
significant
differences
between
the
new
pesticide
and
the
commonly
used
alternatives
Summaries
should
also
include
experimental
methodologies
such
as
application
rates,
application
intervals,
pest
pressure,
weather
conditions,
varieties
of
the
crop
used,
etc.
Unfavorable
results
must
b
included.
Efficacy
experiments
performed
under
substantially
different
conditions
should
not
be
combined
(
examples
include
differences
in
pest
pressure,
geography,
strain/
race
of
pest
and
weather).
Guidance
for
thi
requirement
can
be
obtained
from
standardized
published
tests
such
"
Fungicide
and
Nematicide
Tests,"
"
Insecticide
and
Acaricide
Tests"
and
methods
section
sections
of
juried
professional
journals.

H.
Other
Information.
Submission
of
the
following
additional
information
will
assist
the
Agency
in
making
its
decision
on
the
active
ingredient:

1.
A
copy
of
the
proposed
product
label(
s).
The
Agency
will
consider
all
of
these
criteria
using
a
weight­
of­
evidence
approach.

VIII.
GUIDELINES
FOR
FQPA
RATIONALE
FOR
REDUCED
RISK
PESTICIDES
Reduced­
risk
submissions
should
also
provide
a
rationale
that
explains
how
this
registration
action
complies
with
the
requirements
of
FQPA.
Such
rationale
should
follow
guidance
provided
in
Appendix
A
of
P
Notice
97­
1
(
January
31,
1997).
Such
rationale
should
address
at
a
mini
aggregate
risk,
special
sensitivities,
endocrine
effects
and
potential
common
mechanisms
of
toxicity
with
other
registered
pesticides.
Appendi
is
provided
as
an
attachment
to
this
notice.

IX.
FORMATTING
AND
SUBMITTAL
PROCEDURES
FOR
REDUCED­
RISK
PESTICIDES
Formatting
(
A)
and
submittal
(
B)
procedures
for
Reduced­
Risk
Rationales
are
provided
below.
These
procedures
will
enable
EPA
to
easi
identify
the
application
for
priority
consideration.
Also,
applicants
should
note
that
it
is
unlawful
to
falsify
any
portion
of
an
application
FIFRA
Sections
12(
a)
(
2)(
M),
12(
a)(
2)(
R)
and
18
U.
S.
C.
Section
1001
make
such
actions
unlawful
and
can
result
in
civil
or
criminal
penalties.
Th
Agency
will
not
consider
an
application
under
the
Voluntary
Reduced­
Risk
Pesticide
Initiative
if
the
applicant
does
not
follow
these
procedures.

A.
Format.
The
reduced­
risk
rationale
document
must
include
the
following
elements
in
the
order
indicated:
Title
Page,
Statement
or
Supplemental
Statement
of
Data
Confidentiality
Claims,
Cover
Sheet
to
Confidential
Attachment
and
Confidential
Business
Information
(
CBI)
Reduced­
Risk
Attachment.
Any
supporting
data
must
comply
with
PR
Notice
86­
5
requirements.

The
Reduced­
Risk
Rationale
must
be
bound
as
a
separate
entity
and
consecutively
paginated
beginning
with
the
title
page
as
page
1.
The
to
number
of
pages
must
be
represented
on
the
title
page.
Do
not
include
C
on
the
title
page.
On
the
title
page,
include
titles
and
author(
s).

B.
Submitting
a
Reduced­
Risk
Rationale
Registration
Application.
Reduced­
Risk
Rationale
should
accompany
the
registration
application
and
supporting
data
packages.
This
PR
Notice
does
not
supersede
established
submittal
procedures
as
addressed
in
PR
Notice
91­
5;
rather,
this
PR
Not
provides
additional
guidance
for
submitting
the
reduced­
risk
rationale.
OPP
uses
distribution
codes
to
facilitate
the
delivery
of
registration
a
other
submissions
within
the
program.
When
preparing
your
submission
to
mail
or
deliver
to
OPP,
direct
your
submission
to
the
Document
Processin
Desk
and
including
the
following
distribution
code:
REDUCED­
RISK
APPL.

The
submission
delivered
via
the
U.
S.
Postal
Service
should
be
directed
to
OPP
using
the
following
address:

Document
Processing
Desk
(
REDUCED­
RISK
APPL.)
Office
of
Pesticide
Programs
(
7504C)
U.
S.
Environmental
Protection
Agency
401
M
Street,
S.
W.
Washington,
D.
C.
20460­
0001
Submissions
via
personal
or
courier
delivery
should
be
directed
to
Document
Processing
Desk
between
the
hours
of
8:
00
a.
m.
and
4:
00
p.
m.,
Monday
through
Friday,
excluding
federal
holidays.
OPP's
Document
Processing
Desk
is
located
at
the
following
address:

Office
of
Pesticide
Programs
Document
Processing
Desk
(
REDUCED­
RISK
APPL.)
Room
266A,
Crystal
Mall
2
1921
Jefferson
Davis
Highway
Arlington,
VA
22202
C.
Rebuttals
may
be
submitted
to
Rick
Keigwin,
Registration
Divisi
(
7505C),
U.
S.
Environmental
Protection
Agency,
401
M
Street,
S.
W.,
Washington,
DC
20460.

X.
GUIDELINES
FOR
EXPEDITED
REVIEW
OF
NON­
FAST­
TRACK
NEW
FORMULATIONS
FOR
CURRENTLY
REGISTERED
CONVENTIONAL
PESTICIDES
Some
new,
non­
fast­
track,
formulations
and
amendments
to
currently
registered
conventional
pesticide
products
could
result
in
reduced
risk.
To
qualify,
an
application
for
expedited
review
under
this
section
must
first
demonstrate
that
it
meets
one
or
more
of
the
step
1
criteria
liste
in
section
VI.
A
of
this
notice.
Secondly,
the
registrant
must
demonstra
that
the
new
formulation,
when
compared
with
all
of
the
existing
formulation(
s)
for
the
active
ingredient,
results
in
significant
risk
reduction.
Examples
of
risk
reduction
that
would
most
likely
qualify
fo
expedited
review
include
new
formulations
that
result
in
(
a)
at
least
a
reduction
in
the
amount
of
active
ingredient
applied,
(
b)
at
least
a
ten
fold
reduction
in
risks
to
mixers,
loaders
and
applicators,
(
c)
at
least
50%
reduction
in
the
product's
potential
to
leach
into
groundwater
or
ru
off
into
surface
water
or
(
d)
a
significant
reduction
in
risk
to
non­
tar
species.
Actions
that
are
accepted
will
qualify
for
expedited
review
bu
will
not
be
classified
as
reduced
risk.

The
process
for
submission
of
a
non­
fast­
track
formulation
or
new
end­
use
product
differs
from
the
new
active
ingredient/
new
uses
procedur
For
consideration
of
a
non­
fast­
track
new
formulation/
end­
use
product,
t
registrant
shall
make
a
submission
to
the
Product
Manager
with
documente
rationale
for
consideration
of
expedited
review.
The
Product
Manager
wi
review
the
request
and
determine
if
the
submission
qualifies
for
expedit
review.
Consultation
with
other
Product
Managers
or
Branch
Chiefs
in
Registration
Division
may
be
necessary.
The
Product
Manager
will
notify
the
applicant
of
the
expedited
review
status
within
30
days.
If
denied
expedited
review
status,
there
will
be
one
opportunity
for
rebuttal;
the
submitter
has
four
weeks
to
resubmit
their
rebuttal
to
the
PM.
Finally,
the
applicant
holds
the
registrations
for
the
old
formulations
that
this
new
formulation
will
replace,
a
request
for
cancellation
of
the
old
formulations
is
also
required.
This
cancellation
request
will
not
be
processed
until
a
registration
is
issued
on
the
new
formulation.

XI.
BIOLOGICAL
PESTICIDES
A.
Background.
In
November,
1994,
EPA
established
a
pilot
divisi
the
Biopesticides
and
Pollution
Prevention
Division
(
BPPD),
with
part
of
its
mission
to
expedite
the
registration
and
reregistration
of
biologica
pesticides
(
biopesticides).
Biopesticides
are
any
of
the
following:
(
1
naturally
occurring
or
genetically
altered
microorganisms,
(
2)
plant­
pesticides
(
pesticidal
substances
produced
in
a
plant
and
the
gene
material
necessary
for
the
production
of
those
substances),
or
(
3)
biochemical
pesticides.
In
addition,
BPPD
does
review
the
registration
submissions
for
some
other
pesticidal
substances
which
warrant
a
reduced
data
set
as
described
below
in
Part
C.

BPPD
is
now
a
permanent
part
of
the
Office
of
Pesticide
Programs.
date,
BPPD
has
been
successful
at
expediting
the
registration
of
biologi
pesticides.
Since
the
Division
was
established
in
the
fall
of
1994,
37
biological
pesticides
have
been
registered
including
the
first
plant­
pesticide
products.
New
biopesticide
active
ingredients
are
typically
registered
in
less
than
11
months
which
is
substantially
less
time
than
the
average
review
time
for
conventional
pesticides.

B.
Priority
for
Review
in
BPPD.
EPA
believes
that
biological
pesticides
generally
pose
less
risk
than
most
conventional
pesticides.
Therefore,
EPA
established
BPPD
to
provide
an
expedited
review
to
all
biological
pesticide
products.
BPPD's
priority
of
actions
is
based
upon
the
order
submissions
are
received
rather
than
a
comparison
of
risk
amon
the
biopesticides.
When
a
particular
pesticide
registrant
requests
that
certain
one
of
its
submissions
receives
top
priority
amongst
that
compan
other
biological
actions,
BPPD
honors
the
requests.
Also,
if
a
biopesticide
would
replace
the
use
of
a
hazardous
pesticide
requested
fo
an
emergency
exemption
under
FIFRA
Section
18,
BPPD
would
make
a
case­
by­
case
determination
on
whether
to
further
expedite
the
regulatory
decision.

C.
Characteristics
of
Biopesticides
1.
Microbial
Pesticides.
Microbial
pesticides
contain
a
bacterium,
fungus,
virus,
protozoan
or
alga
as
the
active
ingredient.
Approximately
50
microbial
pesticide
active
ingredients
are
registered
b
EPA.
The
most
widely
known
of
these
are
varieties
of
the
bacterium,
Bacillus
thuringensis
or
Bt,
which
can
control
certain
moths,
beetles,
a
mosquitoes.
Data
requirements
for
microbial
pesticides
are
found
in
40
158.740.
BPPD
encourages
potential
registrants
to
contact
the
Division
a
preregistration
submission
meeting
to
discuss
these
data
requirements,
and
the
scientific
rationales
for
study
waivers.

2.
Plant­
Pesticides.
In
November
of
1994,
EPA
published
a
proposed
rule
for
regulation
of
plant­
pesticides.
In
that
document,
EPA
encouraged
potential
registrants
to
follow
the
proposed
rule
until
the
final
rule
is
published.
To
date,
seven
plant­
pesticide
registrations
h
been
issued.
Once
the
final
rule
is
published,
EPA
will
propose
guideli
for
registration
of
plant­
pesticides
which
will
be
incorporated
into
40
Part
158.
The
guidelines
will
be
open
to
public
comments
and
appropriat
public
meetings
will
be
held
prior
to
final
guidelines
being
issued.
In
the
meantime,
potential
registrants
should
work
closely
with
BPPD
to
determine
the
data
requirements
for
their
products.

3.
Biochemical
Pesticides.
Biochemical
pesticides
are
distinguished
from
conventional
chemical
pesticides
by
their
nontoxic
mo
of
action
toward
target
organisms
(
usually
species
specific),
e.
g.
growt
regulation
or
mating
disruption,
and
by
the
natural
occurrence
of
the
pesticidal
substance.
In
contrast,
conventional
pesticides
generally
ar
toxic
and
may
affect
a
wider
range
of
target
species.
Biochemical
pesticides
generally
fall
into
distinct
biologically
functional
classes:
Semiochemicals
(
chemicals
emitted
by
a
plant
or
animal
that
modify
the
behavior
of
receptor
organisms
of
similar
or
different
species),
hormone
natural
plant
regulators,
natural
insect
growth
regulators,
and
enzymes.
In
many
instances,
biochemical
pesticides
may
be
synthesized
rather
than
isolated
from
nature.
In
order
for
synthesized
pesticides
to
be
conside
as
biochemical
pesticides,
they
must
be
demonstrated
to
be
structurally
similar
and
functionally
identical
to
a
naturally
occurring
biochemical
pesticide.

Although
there
are
no
strict
criteria
for
the
definition
of
biochemical
pesticides,
most
biochemical
pesticides
are
applied
at
very
rates,
are
highly
volatile,
or
are
applied
in
bait,
trap,
or
"
encapsulat
formulations,
thus
resulting
in
less
exposure
(
and
less
likelihood
of
adverse
effects
to
humans
and
the
environment
than
from
use
of
most
conventional
pesticides).
In
keeping
with
their
unique
properties,
biochemical
pesticides
have
been
assigned
a
set
of
data
requirements
whi
are
organized
in
a
tiered
testing
scheme
to
ensure,
to
the
greatest
exte
possible,
that
only
the
minimum
data
sufficient
to
make
scientifically
sound
regulatory
decisions
will
be
required.
The
data
requirements
are
outlined
in
40
CFR
Part
158.690.

4.
Pesticides
Which
Warrant
Reduced
Data
Requirements.
The
Agency
recognizes
that
many
naturally
occurring
pesticidal
chemicals
may
highly
toxic
to
their
target
organisms
and
does
not
intend
to
include
th
as
biochemical
pesticides.
BPPD
has
elected
to
review
certain
of
these
naturally
occurring
pesticides
that
may
operate
via
a
toxic
mode
of
acti
toward
target
organisms,
but
which
a
priori
also
would
be
candidates
for
initial
tiered
data
set,
as
required
for
biochemical
pesticides.
These
"
biochemical­
like"
pesticides
have
not
yet
been
formally
classified
into
subcategory
of
pesticides
for
nomenclature
purposes.
These
pesticides
usually
have
uncomplicated
structures
and
are
commonly
present
in
the
environment
or
the
human
diet
at
significant
levels
or
have
been
widely
used
for
non­
pesticidal
purposes.
Thus,
any
clinical
or
nontarget
effec
are
very
likely
to
have
been
noticed
and
should
be
well
documented.
BPP
has
found
that
potential
registrants
for
these
products
generally
follow
the
same
data
requirements
as
the
biochemicals,
but
a
preregistration
meeting
with
the
Division
is
highly
recommended
before
extensive
testing
and
before
formal
submission
of
an
application.

D.
Guidelines
for
Classification
as
a
Biochemical
or
a
"
Biochemical­
like"
Pesticide
to
be
Reviewed
by
BPPD.
On
request,
the
Biopesticides
and
Pollution
Prevention
Division
(
BPPD)
will
evaluate
products
on
an
individual
basis
to
classify
them
as
biochemical
pesticid
pesticides
warranting
reduced
data
requirements
("
biochemical­
like"),
or
conventional
chemical
pesticides.

BPPD
has
formed
a
Biochemical
Classification
Committee
to
evaluate
written
requests
for
classifying
products
proposed
for
BPPD
review
as
biochemicals
and
similar
products.
A
classification
request
should
incl
information
to
support
the
natural
occurrence
of
the
chemical
and
information
bearing
on
its
mode
of
action
toward
the
target
pest.
Additional
information
to
support
low
toxicity
or
low
exposure
levels
ma
be
useful
if
available.
This
could
include
GRAS
(
generally
regarded
as
safe)
status
(
please
cite
the
listing
number)
or
information
on
applicat
rates
and/
or
degradation
rates.
Published
studies
or
private
data
shoul
be
attached
if
the
supporting
information
is
not
commonly
known
or
obvio
E.
Evaluation
Standards
1.
Natural
Occurrence.
Naturally
occurring
substances
may
be
inorganic
or
organic.
As
noted
above,
if
the
chemical
is
not
naturally
occurring,
information
must
be
provided
showing
that
it
is
structurally
similar
and
functionally
identical
to
a
naturally
occurring
substance.
Biochemical
Classification
Committee
recognizes
that
"
natural
occurrence
may
technically
include
substances
that
occur
at
very
low
levels
in
the
environment,
but
in
such
amounts
or
locations
that
humans
and/
or
nontarg
organisms
have
not
been
exposed
to
significant
levels
of
these
chemicals
The
committee
may
decide
that
these
substances
are
not
biochemical
pesticides
if
there
is
any
indication
that
natural
exposure
levels
are
insufficient
to
indicate
potential
effects
from
the
expected
product
exposure.

2.
Nontoxic
Mode
of
Action.
A
nontoxic
mode
of
action
is
one
that
does
not
kill
the
target
pest.
The
most
obvious
are
repellents
and
attractants.
The
committee
has
also
included
in
the
nontoxic
mode
of
action
category,
those
chemicals
that
may
be
lethal
to
the
target,
but
operate
via
a
physical
mode
of
action
to
control
the
target
pest.
For
example,
certain
oils
and/
or
sticky
substances
can
kill
insects
by
clogg
their
respiratory
spiracles
and
trachea,
but
such
substances
are
not
lik
to
have
adverse
effects
on
non­
target
organisms
or
humans.
Desiccants
al
are
considered
as
acting
via
a
nontoxic
mode
of
action.
Plant
growth
regulators
are
usually
considered
to
have
a
nontoxic
mode
of
action;
however,
some
plant
growth
regulators
may
act
as
herbicides
at
higher
application
rates.
Thus,
higher
application
rates
may
result
in
additio
data
requirements
(
as
required
for
conventional
chemical
herbicides)
or
reclassification
as
a
conventional
chemical
pesticide.

F.
Formatting
and
Submittal
of
Request
for
Biochemical
Classification.
The
classification
request
should
be
in
the
form
of
a
letter
and
should
be
sent
directly
to
the
Biopesticides
and
Pollution
Prevention
Division
(
7511W),
Office
of
Pesticide
Programs,
US
Environmen
Protection
Agency,
401
M
St
SW,
Washington,
DC
20460.
It
should
be
labe
"
Attn.:
Biochemical
Classification
Committee."

G.
EPA
Response
to
Request
for
Biochemical
Classification.
Submissions
for
classification
are
reviewed
by
a
team
of
scientists
from
several
divisions
within
OPP.
The
recommendations
of
the
Committee
are
brought
to
management
for
approval.
Decisions
can
include
classificatio
as
a
biochemical,
classification
as
a
"
biochemical­
like"
substance
that
warrants
reduced
data
requirements,
but
is
not
a
biochemical,
or
classification
as
a
conventional
pesticide.
The
potential
registrant
is
informed
by
letter
of
the
decision.
Because
these
are
preapplication
requests
for
classification,
the
information
submitted
and
the
results
m
upon
request,
be
treated
as
confidential
business
information.

H.
Rebuttals
to
Denials
for
Biochemical
Classification.
In
some
cases,
inadequate
information
is
supplied
so
that
a
Committee
recommendation
cannot
be
made.
In
these
cases
the
potential
registrant
asked
to
submit
additional
information.
If
a
potential
registrant
disagrees
with
classification
as
a
conventional
pesticide
(
essentially
a
denial
of
classification
as
a
biochemical),
a
rebuttal
can
be
submitted
the
Biochemical
Classification
Committee
for
reconsideration.

XII.
FOR
FURTHER
INFORMATION
For
further
information
on
reduced­
risk
submissions
for
conventiona
pesticides,
contact
Peter
Caulkins,
Associate
Director,
Registration
Division
at
(
703)
305­
6550.
For
further
information
on
antimicrobial
pesticides,
contact
Bill
Jordan,
Associate
Director,
Antimicrobials
Division
at
(
703)
308­
6411.
For
further
information
on
microbial
and
plant­
pesticides,
contact
Phil
Hutton,
Chief,
Microbial
Pesticides
Branc
BPPD
at
(
703)
308­
8260
and
for
biochemicals,
contact
Roy
Sjoblad,
Chief,
Biochemical
Pesticides
Branch,
BPPD
at
(
703)
308­
8269.

Daniel
M.
Barolo,
Director
Office
of
Pesticide
Programs
APPENDIX
A
CONTENT
OF
SUPPLEMENTAL
INFORMATION
As
indicated
at
the
beginning
of
the
PR
Notice,
registrants,
applicants
and
petitioners
are
not
currently
required
to
submit
any
additional
information.
Nevertheless,
since
the
new
statute
requires
th
Agency
to
consider
additional
information
in
order
to
make
the
necessary
decisions,
EPA
recognizes
that
many
registrants,
applicants
and
petition
may
wish
to
provide
the
supplemental
information
to
the
Agency
even
with
a
requirement
to
do
so.
For
those
registrants,
applicants
or
petitione
who
wish
to
supplement
their
original
submissions
with
additional
information,
this
Appendix
describes
what
information
the
Agency
would
consider
helpful
additions
for
its
review.(*
1)
(*
1)
An
agency
may
not
conduct
or
sponsor,
and
a
person
is
not
required
to
respond
to,
a
collection
of
information
unless
it
eithe
displays
a
currently
valid
OMB
control
number
or
is
imposed
on
the
person
by
statute
(
5
CFR
1320.6(
a)
&
(
e)).
The
collection
of
information
relating
to
the
registration,
reregistration,
and
tolerance
programs
have
are
approved
under
OMB
Control
Numbers
2070­
0024
(
expires:
6/
30/
99);
2070­
0032
(
expires:
5/
3/
98);
2070­
004
(
expires:
11/
30/
99);
2070­
0060
(
expires:
5/
31/
98);
2070­
0122
(
expir
11/
30/
97);
2070­
0107
(
expires:
7/
31/
99).
If
you
should
have
any
comments
on
the
collection
activities,
please
send
them
to
the
Director,
OPPE
Regulatory
Information
Division,
U.
S.
Environmental
Protection
Agency
(
Mailcode
2137),
401
M
St.,
S.
W.,
Washington,
D.
C
20460.
Include
the
OMB
control
number
in
any
correspondence.
Note
that
this
address
is
ONLY
for
comments
on
the
collection
activity.
not
submit
your
information
to
this
address.

All
tolerances
or
tolerance
exemptions
and
associated
registration
actions
under
FIFRA
section
3
or
reregistration
actions
under
FIFRA
sect
4,
whether
pending
or
future,
will
need
to
comply
with
the
new
safety
standard
of
section
408(
b)(
2)
of
the
Federal
Food,
Drug
and
Cosmetic
Ac
In
addition,
because
EPA
intends
to
apply
a
similar
standard
to
actions
involving
non­
food
use
pesticides
that
may
pose
significant
non­
dietary
risks
to
infants
and
children,
all
registration
and
reregistration
actio
also
will
need
to
comply
with
this
standard
with
respect
to
the
Agency's
consideration
of
infants
and
children
exposure
to
the
pesticide.

In
preparing
a
package
to
be
submitted,
those
seeking
a
registratio
reregistration,
tolerance,
or
an
exemption
from
the
requirement
of
a
tolerance
for
a
food
use
pesticide,
or
a
registration
or
reregistration
a
non­
food
use
pesticide
that
may
result
in
significant
exposure
to
children,
may
need
to
provide
additional
information
and/
or
materials
to
address
adequately
the
factors
and
specific
questions
contained
here.
Those
who
wish
to
submit
additional
information
should
keep
in
mind
that
the
Agency
will
consider
each
factor
listed
below
(
and
perhaps
others
as
Agency
policies
are
developed)
in
addition
to
any
data
and
information
already
required.
In
addition,
it
is
important
to
note
that
the
information
identified
here
may
not
be
definitive
in
all
cases.
Additio
information
or
more
detailed
information
may
be
needed
in
individual
cas
If
a
registrant,
applicant,
or
petitioner
can
identify
additional
information
that
would
assist
the
Agency
in
addressing
the
FQPA
provisio
EPA
welcomes
such
information.
Although
the
submission
of
this
informat
is
not
currently
required
by
the
regulations,
if
such
information
is
not
submitted,
the
Agency
must
rely
on
previously
submitted
data,
if
applicable,
or
on
broad
or
default
assumptions
when
considering
the
fact
listed.
As
a
result,
favorable
action
on
an
application,
petition,
or
reregistration
decision
may
be
significantly
delayed
or
precluded
altogether.

It
would
be
helpful
for
any
submitted
documentation
to
contain
a
discussion
of
each
of
the
following
factors
as
it
relates
to
the
pestici
and
proposed
tolerance
or
tolerance
exemption.
If
information
on
any
factor
is
not
known,
that
fact,
along
with
an
explanation,
should
be
not
in
the
rationale.
It
is
important
to
note
that
EPA
does
not
expect
the
registrant,
applicant,
or
petitioner
at
this
time
to
perform
any
additio
testing
to
derive
the
data
necessary
to
develop
its
rationales.
However
if
it
has
in
its
possession
data
from
preliminary
reports
of
ongoing
studies,
articles
from
published
literature,
unpublished
report
information,
previously
unsubmitted
studies,
or
supplemental
data
that
a
otherwise
pertinent
to
the
Agency's
concerns,
the
party
is
encouraged
to
submit
them.
Likewise,
if
a
registrant,
applicant,
or
petitioner
believ
that
a
factor
is
not
applicable
to
its
product,
a
discussion
as
to
why
t
view
is
held
should
also
be
included.
The
Agency
will
consider
all
relevant
factors
in
determining
an
application's
completeness
and
in
setting
priorities
for
review.

Based
on
the
new
safety
standard,
EPA
will
need
the
following
additional
information
in
order
to
make
appropriate
regulatory
decisions
(
For
details
on
each
factor,
please
refer
to
the
explanations
below
in
parts
A
and
B.)

1.
An
informative
summary
of
the
petition
or
application,
including
a
summary
of
the
supporting
data,
information,
accompanying
rationale
and
a
statement
providing
permission
to
publish
such
summary,
and
2.
Information
and
discussion
pertaining
to
a
specific
safety
determination
for
infants
and
children
including
their
special
susceptibilities
and
exposure
patterns
to
the
particular
pesticide.

A.
Food
Use
Pesticides:
Registration
and
Reregistration
Actions,
Experimental
Use
Permits,
Tolerance
(
or
Exempti
Petitions
and
Reassessments
In
the
format
described
in
Appendix
C
of
this
PR
Notice,
address
ea
of
the
following
with
respect
to
the
pesticide
and
its
use(
s):
Special
Sensitivities
a)
Chronic
Endpoints
For
a
chemical
pesticide:
Discuss
and/
or
provide
evidence
as
to
whether
or
not
the
current
Reference
Dose
(
RfD)
is
sufficient
to
adequately
protect
infants
and
children.
Discuss
and/
or
provide
evidence
as
to
whether
or
not
infants
and
children
are
more
susceptible
to
the
chemical.
If
you
believe
that
an
additional
saf
factor
of
10X,
to
take
into
account
potential
pre­
and
post­
natal
toxicity
to
infants
and
children
is
not
necessary,
provide
evidence
support
the
additional
safety
factor,
if
any,
you
believe
to
be
mor
appropriate.
Please
bear
in
mind
that
the
Agency
may
accept
a
different
margin
of
safety
only
if,
based
on
reliable
data,
EPA
concludes
that
the
margin
will
be
safe
for
infants
and
children.

For
a
biochemical
pesticide:(*
2)
(*
2)
A
biochemical
is
a
naturally­
occurring
compound,
or
substantially
similar
to
a
naturally­
occurring
compound,
with
non­
toxic
mode
of
action
to
the
target
pest.
Does
the
toxicity
testing
indicate
that
the
establishment
of
an
RfD
warranted?
If
so,
then
discuss
whether
or
not
the
RfD
is
sufficien
to
adequately
protect
infants
and
children.
Discuss
and/
or
provide
evidence
as
to
whether
or
not
infants
and
children
are
more
susceptible
to
the
biochemical
pesticide.

For
a
microbial
pesticide:(*
3)
(*
3)
Certain
subpopulations
are
more
susceptible
to
certain
disease­
causing
microorganisms;
however,
these
are
not
the
typ
of
microorganisms
that
are
considered
for
registration
or
use
microbial
pesticides.
The
Agency
has
not
registered,
and
does
not
expect
to
register
a
microbial
active
ingredient
that
is
known
to
be
a
common
human
pathogen.
To
address
the
potential
risk
from
microbial
pesticides,
the
Agency
requires
a
battery
acute
toxicity/
pathogenicity
studies
in
order
to
perform
a
risk
assessment.
If
results
of
the
acute
exposure
studies
indicate
a
toxicity
concern,
then
subchronic
or
chronic
studie
are
required.
Discuss
the
potential
for
chronic
dietary
risks
for
infants
and
children.
Discuss
and/
or
provide
evidence
as
to
whether
or
not
infants
and
children
are
more
susceptible
to
the
microbial
pesticid
than
is
the
adult
population.

b)
Acute
Endpoints
Discuss
the
potential
for
greater
acute
dietary
risk
for
infants
an
children.
If
the
chemical
or
biochemical
pesticide
demonstrates
ac
effects,
then
discuss
the
endpoint
used
to
perform
the
assessment
including
relevance
to
infants
and
children
and
the
details
as
to
h
the
exposure
assessment
was
conducted
and
whether
the
estimated
ris
is
within
the
Agency's
levels
of
concern.

c)
Carcinogenic
Endpoints
If
the
chemical
or
biochemical
has
been
determined
to
be
a
carcinog
and
has
a
cancer
potency
factor
(
Q1*),
discuss
the
aggregate
exces
lifetime
cancer
risk
resulting
from
exposure
to
the
chemical
from
residues
in
food
and
drinking
water
(
ground
and
surface
water)
and
from
residential
and
other
non­
occupational
source(
s).

Aggregate
Exposure
a)
Water
For
a
chemical
or
biochemical
pesticide:
Discuss
the
potential
for
the
transfer
of
residues
(
of
both
the
parent
pesticide
and
any
degradates)
to
drinking
water.
The
discussion
should
include,
but
be
limited
to,
information
indicating
whether
the
pesticide
is
persistent
and/
or
mobile,
relevant
product
chemistry,
and
any
available
modeling
data.

Has
the
chemical
or
any
of
its
degradates
been
detected
in
ground
water
or
surface
water?
Would
this
chemical
or
any
of
its
degradat
likely
pass
through
primary
or
secondary
drinking
water
treatment
i
finished
water?
Are
any
States
conducting
water
monitoring
program
for
this
pesticide?
If
so,
data
collected
by
the
States
and
all
relevant
information
should
also
be
included.

For
a
microbial
pesticide:
Discuss
the
potential
for
the
transfer
the
microbial
pesticide
to
drinking
water.
The
discussion
should
include,
but
not
be
limited
to,
information
pertaining
to
the
biolo
of
the
microorganism,
and
indicating
whether
the
pesticide
is
persistent
and/
or
mobile
or
has
the
potential
for
transport
in
air
(
spray
drift
and
volatility
data).
Are
any
States
conducting
water
monitoring
programs
for
this
strain?
If
so,
data
collected
by
the
States
and
all
other
relevant
information
should
also
be
included.

b)
Non­
occupational
Exposures
Discuss
the
potential
for
significant
exposure
to
the
pesticide
of
children
by
routes
other
than
dietary.
Are
there
any
non­
occupational,
structural,
or
residential
uses
(
e.
g.,
pet,
swimm
pool,
lawn
and
garden,
or
topical
insect
repellent)?
Is
the
pestic
used
in
or
around
schools,
parks,
or
recreation
facilities?
Provid
all
available
exposure
data.
If
the
pesticide
demonstrates
acute
effects,
then
discuss
the
endpoint
used
to
perform
the
assessment,
including
relevance
to
infants
and
children
and
the
details
of
how
residential
exposure
assessment
was
conducted
and
whether
the
estimated
risk
is
within
the
Agency's
levels
of
concern.

c)
Multiple
Pathway
Assessment
Discuss
the
chronic
and/
or
acute
risk
of
aggregate
exposure
via
multiple
pathways
for
the
general
population,
and
for
infants
and
children.
This
should
include
a
discussion
of
all
assumptions
used
and
uncertainties.
You
should
also
identify,
and
include
in
the
discussion,
any
non­
pesticidal
uses
of
the
chemical
(
e.
g.,
industri
pharmaceutical,
cosmetic,
food
additive).

Cumulative
Effects
Discuss
the
mechanism
and
mode
of
action
of
this
pesticide.
Identi
other
chemicals
that
may
fall
into
this
category
(
both
pesticide
an
non­
pesticide
chemicals).
Provide
information
regarding
common
mechanisms
and
modes
of
action
with
other
chemical
substances
based
structural
similarity,
same
or
similar
endpoints,
and
other
relevan
criteria.
Provide
any
data
and/
or
evidence
illustrating
similariti
at
the
cellular/
molecular
level.

Discuss
the
appropriateness
of
combining
exposures
in
this
particul
case.
Where
data
are
not
available,
discuss
appropriateness
of
usi
default
assumptions
and
what
defaults
should
be
used.

Endocrine
Effects(*
4)
(*
4)
As
indicated
in
section
408(
p)(
1)
&
(
2),
the
Agency
has
2
years
to
develop
a
screening
method,
with
a
total
of
3
years
t
implement
such
a
program.

Discuss
and
provide
any
evidence
relevant
to
the
possibility
that
t
pesticide
may
have
endocrine
disrupter
effects
individually
or
in
combination
with
another
chemical.
Include
the
potential
for
synergistic
effects
of
your
chemical
in
combination
with
other
chemicals.
Identify
any
instances
of
reported
(
proven
or
alleged)
adverse
reproductive
or
developmental
effects
to
domestic
animals
or
wildli
as
a
result
of
exposure
to
your
chemical,
or
that
occurred
in
an
ar
where
the
chemical
is
known
to
have
been
used.
Provide
all
information
regarding
the
circumstances,
estimated
level
of
exposur
and
details
of
the
effect.

Residue
Chemistry
Information
should
include
a
discussion
of
compatibility
with
established
Codex
Alimentarius
Commission
Maximum
Residue
Levels
(
MRLs),
submission
of
a
practical
analytical
method
with
an
appropriate
limit
of
detection,
and
a
discussion
of
the
potential
n
for
tolerances
for
processed
foods.
For
tolerance
exemption
petitions,
indicate
if
the
chemical
is
on
the
Food
and
Drug
Administration's
Generally
Recognized
As
Safe
(
GRAS)
list.
A
summa
of
all
tolerances
and
exemptions
from
tolerance
being
proposed
shou
also
be
included.

Benefits
Information
(
For
Reregistration
Actions
Only)

If
the
information
and
data
submitted
indicate
that
an
existing
tolerance,
reviewed
according
to
the
requirements
of
the
new
legislation
should
be
determined
to
be
unsafe
(
that
is,
to
exceed
the
"
reasonable
certainty
of
no
harm"
standard),
the
new
law
allows
EPA
to
consider
pesticide
benefits
information
in
certain
instances.
An
"
eligible
pesticide
chemical
residue"
(
for
which
an
"
eligible
tolerance"
may
be
applicable)
is
defined
as
a
chemical
residue
for
which
1)
EPA
is
unable
to
identify
a
level
of
exposure
that
will
not
cau
or
contribute
to
a
known
or
anticipated
harm
to
human
health
(
that
the
effect
is
a
non­
threshold
effect);

2)
an
appropriate
quantitative
risk
assessment
for
the
lifetime
ri
of
the
non­
threshold
effect
has
been
determined;
and
3)
if
there
are
also
threshold
effects
associated
with
the
chemica
EPA
is
able
to
identify
a
level
at
which
the
residue
will
not
cause
any
known
or
anticipated
harm
to
human
health
and
that
the
level
o
aggregate
exposure
is
safe.

Registrants
who
suspect
that
an
existing
tolerance
for
their
chemic
which
has
been
classified
by
the
Agency
as
exhibiting
a
non­
threshold
effect,
may
exceed
the
new
safety
standard,
and
wish
the
Agency
to
consi
an
eligible
tolerance
for
residues
of
that
pesticide,
may
need
to
submit
the
following
information:

Conditions
Regarding
the
Use
of
the
Pesticide
Information
and/
or
data
indicating
that
the
use
of
the
pesticide
chemical
that
produces
the
residue
protects
consumers
from
adverse
health
effects
that
would
pose
a
greater
risk
than
the
dietary
risk
from
the
residue,
OR
Information
and/
or
data
showing
that
the
use
of
the
pesticide
chemi
that
produces
the
residue
is
necessary
to
avoid
a
significant
disruption
in
the
domestic
production
of
an
adequate,
wholesome,
an
economic
food
supply.

Conditions
Regarding
the
Risk
of
a
Pesticide
Evidence
that
the
yearly
risk
associated
with
the
nonthreshold
effe
from
aggregate
exposure
to
the
residue
is
not
greater
than
ten
time
the
yearly
risk
allowed
under
the
new
safety
standard,
AND
Evidence
that
the
tolerance
is
limited
to
ensure
that
the
lifetime
risk
associated
with
the
nonthreshold
effect
from
aggregate
exposur
to
the
residue
is
not
greater
than
twice
the
lifetime
risk
allowed
under
the
new
safety
standard.

It
is
important
to
note
that
the
above
information
does
not
superse
any
existing
benefits
requirements
under
FIFRA,
such
as
public
health
pe
and
benefits
data
necessary
for
a
public
interest
finding
under
FIFRA
section
(
3)(
c)(
7).

B.
Non­
Food
Use
Pesticides:
Registration
or
Reregistration
Actions
In
the
format
described
in
Appendix
C
of
this
PR
Notice,
address
ea
of
the
following
with
respect
to
the
pesticide
and
its
use(
s):

Potential
for
Exposure
to
Children
Describe
the
use
pattern
of
your
chemical.
If
you
believe
that
its
use(
s)
would
not
potentially
result
in
significant
exposure
to
infa
and
children,
provide
a
discussion
and
rationale
as
to
why
this
vie
is
held.
For
chemicals
that
appear
not
to
result
in
a
significant
exposure
to
infants
and
children,
no
additional
information
is
need
If
you
believe
that
the
use
of
your
chemical
may
result
in
significant
children's
exposure,
the
following
factors
may
need
to
be
addressed:

Special
Sensitivities
Discuss
and/
or
provide
evidence
as
to
whether
or
not
infants
and
children
are
more
susceptible
to
the
chemical
than
adults.

Discuss
the
potential
for
greater
acute
and/
or
chronic
risk
for
infants
and
children.
If
the
pesticide
demonstrates
toxic
effects,
then
discuss
the
endpoint
used
to
perform
the
assessment
including
relevance
to
infants
and
children
and
the
details
as
to
how
the
exposure
assessment
was
conducted
and
whether
the
estimated
risk
is
within
the
Agency's
levels
of
concern.

Aggregate
Exposure
Discuss
the
potential
for
the
transfer
of
residues
of
both
the
pare
chemical
and
any
degradates
or
of
the
microbial
pesticide
to
drinki
water.
For
chemical
pesticides,
the
discussion
should
include,
bu
not
be
limited
to,
information
indicating
whether
the
pesticide
is
persistent
and/
or
mobile,
the
potential
for
transport
in
air
(
spray
drift
and
volatility
data),
and
any
available
modeling
data.
For
microbial
pesticides,
the
discussion
should
instead
include
information
pertaining
to
the
biology
of
the
microorganism
and
indicate
whether
the
pesticide
is
persistent
and/
or
mobile.

Has
the
chemical
or
any
of
its
degradates
been
detected
in
ground
water
or
surface
water?
Would
this
chemical
or
any
of
its
degradat
likely
pass
through
primary
or
secondary
drinking
water
treatment
i
finished
water?
Are
any
States
conducting
water
monitoring
program
for
this
pesticide?
If
so,
data
collected
by
the
States
and
all
relevant
information
should
also
be
included.

Discuss
the
potential
for
significant
exposure
to
the
chemical
of
children
by
non­
dietary
routes.
Are
there
non­
occupational,
structural,
or
residential
uses
(
e.
g.,
pet,
swimming
pool,
lawn
and
garden,
or
topical
insect
repellents)?
Is
the
pesticide
used
in
or
around
schools,
parks,
or
recreation
facilities?
Provide
all
available
exposure
data.

Discuss
the
chronic
and/
or
acute
risk
of
aggregate
exposure
via
multiple
pathways
for
the
general
population,
infants
and
children
should
include
a
discussion
of
all
assumptions
used
and
uncertainti
Identify
other
non­
pesticidal
uses
of
the
chemical
(
e.
g.,
industria
pharmaceutical,
cosmetic,
food
additive).

Cumulative
Effects
Discuss
the
mechanism
and
mode
of
action
of
this
pesticide.
Identi
other
chemicals
that
may
fall
into
this
category
(
both
pesticide
an
non­
pesticide
chemicals).
Provide
information
regarding
common
mechanisms
and
modes
of
action
with
other
chemical
substances
based
structural
similarity,
same
or
similar
endpoints,
and
other
relevan
criteria.
Provide
any
data
and/
or
evidence
illustrating
similariti
at
the
cellular/
molecular
level.

Discuss
the
appropriateness
of
combining
exposures
in
this
particul
case.
Where
data
are
not
available,
discuss
appropriateness
of
usi
default
assumptions
and
what
defaults
should
be
used.

Endocrine
Effects
Discuss
and
provide
any
evidence
relevant
to
the
possibility
that
t
chemical
may
have
endocrine
disrupter
effects
individually
or
in
combination
with
another
chemical.
Include
the
potential
for
synergistic
effects
of
your
chemical
in
combination
with
other
chemicals
and
whether
or
not
your
chemical
could
act
as
a
catalyst
another
hormone­
disrupting
chemical.

Identify
any
instances
of
reported
(
proven
or
otherwise)
adverse
reproductive
or
developmental
effects
to
domestic
animals
or
wildli
as
a
result
of
exposure
to
your
chemical,
or
that
occurred
in
an
ar
where
the
chemical
is
known
to
has
been
used.
Provide
all
informat
regarding
the
circumstances,
estimated
level
of
exposure,
and
detai
of
the
effect.

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February
5th,
2003
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