Document ID: EPA-HQ-OPP-2004-0415-0014
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2006-03-08T05:00Z

ECONOMIC
ANALYSIS
OF
THE
PROPOSED
CHANGE
IN
DATA
REQUIREMENTS
RULE
FOR
BIOCHEMICAL
AND
MICROBIAL
PESTICIDES
Prepared
by:

Field
and
External
Affairs
Division
Office
of
Pesticide
Programs
U.
S.
Environmental
Protection
Agency
1200
Pennsylvania
Ave,
NW
Washington,
DC
20640
February
2,
2006
1
TABLE
OF
CONTENTS
1
Executive
Summary...............................................................................................................
4
2
Problem
Statement
................................................................................................................
7
2.1
Overview
of
Biochemical
and
Microbial
Pesticide
Usage,
Exposure,
and
Effects
...........
7
2.2
Nature
of
Market
Failures
Inherent
from
Pesticide
Producer
and
User
Behavior............
8
2.3
Overview
of
the
Proposed
Rule.....................................................................................
8
2.4
Statutory
Authority
for
the
Proposed
Rule
..................................................................
10
2.5
Description
of
the
Proposed
Rule
Data
Requirements
.................................................
11
2.6
Types
of
Data
Requirement
Changes
in
the
Proposed
Rule..........................................
13
3
Alternative
Options
to
the
Proposed
Rule
............................................................................
14
3.1
Low­
cost
Alternative:
Waive
and
Reduce
Certain
Proposed
Tier
I
Data
Requirements..............................................................................................................
15
3.2
High­
cost
Alternative:
Require
Proposed
Tier
I
Data
Requirements
100%
of
the
Time
...............................................................................................................
15
4
Industry
Profile
of
the
Regulated
Community
......................................................................
15
4.1
Biochemical
and
Microbial
Pesticide
Registrant
Universe
............................................
15
4.2
Registrant
Financial
Data
............................................................................................
16
5
Economic
Impacts
on
Pesticide
Registrants
Due
to
Changes
in
Data
Requirements..............
17
5.1
Unit
Test
Costs
(
Step
1)
.............................................................................................
20
5.2
Data
Requirements
Per
Registration
Action
(
Step
2)
...................................................
20
5.3
Incremental
Costs
Per
Registration
Action
(
Step
3).....................................................
21
5.3.1
Estimation
of
Incremental
Costs
......................................................................
21
5.4
Industry­
Wide
Impacts
(
Step
4)
..................................................................................
22
5.5
Average
Annual
Cost
per
Firm
(
Step
5)
......................................................................
24
5.5.1
Annual
Data
Requirement
Costs......................................................................
24
5.5.2
Reporting
and
Recordkeeping
Burden
and
Costs
.............................................
25
5.5.3
Summary
of
Annual
Costs
per
Firm.................................................................
26
6
Estimated
Impacts
of
Data
Waivers
.....................................................................................
27
6.1
Data
Waiver
Analysis:
Biochemical
Pesticides............................................................
28
6.2
Data
Waiver
Analysis:
Microbial
Pesticides................................................................
31
7
Option
Analysis
...................................................................................................................
34
7.1
Proposed
Rule:
Decision
Criteria
Determination
and
Likelihood
of
Data
Requirement
Waivers..................................................................................................
34
7.2
Low­
Cost
Alternative:
Waive
(
for
Biochemical
Pesticides)
and
Reduce
by
50%
(
for
Microbial
Pesticides)
Certain
Proposed
Tier
I
Data
Requirements
...............................
36
7.3
High­
Cost
Alternative:
Require
Proposed
Tier
I
Data
100%
of
the
Time.....................
37
8
Small
Business
Impacts........................................................................................................
37
8.1
Regulatory
Overview..................................................................................................
38
8.2
Categorization
of
Small
Businesses
.............................................................................
38
8.2.1
Estimation
of
the
Number
of
Small
Businesses
................................................
38
8.2.2
Sales
and
Employees
.......................................................................................
39
8.3
Small
Business
Impact
................................................................................................
40
9
Limitations
of
the
Economic
Analysis
..................................................................................
41
10
Estimation
of
Agency
Burden..............................................................................................
44
References
................................................................................................................................
45
2
Appendix
A:
Test
Cost
Data
Used
to
Calculate
Guideline
Costs
for
40
CFR
Part
158
Subparts
L&
M....................................................................................................................
46
Appendix
B:
Data
Requirement
Testing
Probabilities
by
OPPTS
Guideline
Number...................
64
3
LIST
OF
TABLES
AND
CHARTS
Table
2­
1:
Cross
Reference
Between
Current
and
Proposed
40
CFR
Part
158
Subparts...............
9
Table
2­
2:
Data
Categories
and
Descriptions
.............................................................................
12
Table
2­
3:
Types
of
Registration
Actions
and
Descriptions
........................................................
12
Table
4­
1:
Primary
Industry
Sectors
Represented
in
the
OPPIN
Data
Set
..................................
17
Chart
5­
1:
Methods
Flowchart
for
Analyzing
the
Economic
Impacts
of
the
40
CFR
Part
158
Subparts
L&
M
Proposed
Rule...........................................................................................
19
Table
5­
1:
Total
Annual
Cost
of
the
Proposed
Rule
and
Alternative
Data
Requirements
to
Biochemical
and
Microbial
Pesticide
Industry
....................................................................
24
Table
5­
2:
Annual
Cost
per
Firm
of
the
Proposed
Rule
and
Alternative
Data
Requirements
to
Biochemical
and
Microbial
Pesticide
Industry................................................................
25
Table
5­
3:
Annual
Biochemical
or
Microbial
Registrant
Reporting
and
Recordkeeping
Burden
Due
to
Proposed
Changes
to
40
CFR
Part
158
Subparts
L&
M:
New
Active
Ingredients
and
New
Uses1
................................................................................................
26
Table
5­
4:
Total
Average
Annual
Cost
per
Firm
Due
to
Proposed
Changes
to
40
CFR
Part
158
Subparts
L&
M............................................................................................................
27
Table
6­
1:
Impacts
of
Historical
Waiver
Analysis
on
Biochemical
and
Microbial
Pesticide
Registrations
.....................................................................................................................
32
Table
6­
2:
Impact
of
Modified
Waiver
Analysis
on
Biochemical
and
Microbial
Pesticide
Registrations
.....................................................................................................................
33
Table
6­
3:
Registration
Costs
Avoided
Due
to
Waivers 
Biochemical
Pesticides.......................
33
Table
6­
4:
Registration
Costs
Avoided
Due
to
Waivers 
Microbial
Pesticides...........................
33
Table
8­
1:
Companies
in
the
PRATS
Sample
by
SBA
Size
........................................................
39
Table
8­
2:
Average
Sales
and
Employees
B
PPIS
Data
Set.........................................................
39
Table
8­
3:
Number
of
Entities
in
Sample
per
SBA
Category
from
PRATS
Sample.....................
40
Table
8­
4:
Incremental
Cost
Savings
for
Small
Firms
Potentially
Affected
by
the
Proposed
Rule
..................................................................................................................................
41
Table
10­
1:
Biochemical
or
Microbial
Registration
Burden
and
Costs
Due
to
Proposed
Changes
to
40
CFR
Part
158
Subparts
L&
M
Per
Registration
Action
................................
44
4
1
EXECUTIVE
SUMMARY
The
U.
S.
Environmental
Protection
Agency
(
EPA,
or
the
Agency)
is
proposing
to
update
and
revise
the
data
requirements
for
the
registration
of
biochemical
and
microbial
pesticide
products
that
are
listed
in
part
158
of
title
40
of
the
Code
of
Federal
Regulations
(
CFR).
As
indicated
in
the
proposed
rule
for
conventional
pesticides,
40
CFR
part
158
was
reorganized,
and,
as
a
result,
the
following
two
subparts
were
created:
subpart
L
(
§
158.900)
and
subpart
M
(
§
158.1000),
for
biochemical
and
microbial
pesticides,
respectively
(
hereafter
referred
to
as
"
subparts
L&
M").
Biochemical
pesticides
are
generally
naturally
occurring
and
have
a
non­
toxic
mode
of
action.
Microbial
pesticides
are
living
organisms
such
as
viruses,
bacteria,
fungi,
or
protozoa.
This
proposal
is
applicable
to
both
manufacturing­
use
and
end­
use
biochemical
and
microbial
pesticide
products.
It
does
not
include
data
requirements
for
conventional
pesticides;
antimicrobial
pesticides;
or
changes
to
existing
spray
drift
data
requirements.
This
document
evaluates
the
potential
benefits
and
costs
expected
as
a
result
of
the
revisions
presented
in
the
proposed
rule
and
two
alternatives
to
the
proposal.

Federal
law
requires
that
before
selling
or
distributing
a
pesticide
in
the
United
States,
a
person
or
company
must
obtain
registration,
or
license,
from
the
EPA.
Before
registering
a
new
pesticide
or
new
use
for
a
registered
pesticide,
EPA
must
first
ensure
that
the
pesticide,
when
used
according
to
label
directions,
can
be
used
with
a
reasonable
certainty
of
no
harm
to
human
health
and
without
posing
unreasonable
risks
to
the
environment.
Where
pesticides
may
be
used
on
food
or
feed
crops,
EPA
also
sets
tolerances
(
maximum
pesticide
residue
levels)
for
the
amount
of
the
pesticide
that
can
legally
remain
in
or
on
foods.
EPA
requires
applicants
to
provide
EPA
with
the
data
and
other
information
necessary
to
make
such
determinations.

In
1984,
the
Agency
finalized
the
data
requirements
to
support
the
registration
of
biochemical
and
microbial
pesticides
(
49
FR
42856;
October
24,
1984).
When
promulgated,
EPA
distinguished
"
biochemical"
and
"
microbial"
from
a
"
conventional
chemical"
by
"
their
unique
modes
of
action,
low
use
volume,
target
species
specificity
or
natural
occurrence"
in
40
CFR
158.690
and
158.740,
respectively.
Over
the
past
twenty
years,
the
Agency
has
determined
that
while
many
biochemical
and
microbial
pesticide
data
requirements
coincide
with
conventional
pesticides,
some
do
not.

Additionally,
information
needed
to
support
the
registration
of
biochemical
and
microbial
pesticides
has
evolved
as
the
general
scientific
understanding
of
the
potential
hazards
posed
by
pesticides
has
grown.
Over
the
past
20
years,
updated
data
requirements
were
developed
by
EPA,
using
a
process
that
involved
public
participation
and
extensive
involvement
by
the
scientific
community,
including
peer
review
by
the
FIFRA
Scientific
Advisory
Panel
(
SAP).
Most
of
the
data
requirements
contained
in
this
proposal
have
been
applied
on
a
case­
by­
case
basis
to
support
individual
applications.
It
is
extremely
rare
for
data
requirements
to
be
imposed
via
Data
Call­
In
(
DCI)
on
all
registrants
of
similar
products.
Although
the
data
requirements
imposed
have
progressed
as
scientific
understanding
and
concerns
have
evolved,
the
codified
data
requirements
in
part
158
subparts
L&
M
have
not
been
updated.

The
proposed
rule
involves
changes
to
the
codified
data
requirements
that
pertain
to
product
chemistry,
toxicology,
residue
chemistry,
applicator
exposure,
non­
target
terrestrial
and
5
aquatic
organisms,
non­
target
plant
protection,
and
environmental
fate.
Coupled
with
updating
the
data
requirements
reorganized
into
part
158
subparts
L&
M,
EPA
is
proposing
to
add
certain
new
data
requirements
in
response
to
the
need
for
strengthened
risk
assessment
mandated
by
the
Food
Quality
Protection
Act
(
FQPA).
Additionally,
EPA
is
proposing
to
revise
the
definition
of
a
biochemical
pesticide
since
over
the
past
20
years
the
science
has
evolved
and
EPA
has
gained
a
better
understanding
of
this
category
of
pesticides.

The
Agency
believes
codifying
existing
data
requirements
that
are
currently
applied
on
a
case­
by­
case
basis
will
result
in
the
following
benefits:

°
Improve
the
understanding
and
better
prepare
the
pesticide
industry,
along
with
other
partners
in
the
regulated
community,
for
the
biochemical
and
microbial
pesticide
registration
process;
°
Improve
the
availability
of
more
complete
and
reliable
data,
°
Increase
the
Agency=
s
ability
to
meet
statutory
requirements;
°
Better
inform
and
enhance
efficiencies
in
the
regulatory
and
licensing
decisions;
°
Improve
the
Agency=
s
ability
to
prepare
good
quality
risk
assessments;
°
Enhance
the
consideration
of
risk
mitigation
measures;
and
°
Provide
better
protection
to
human
health
and
the
environment.

These
improvements
in
EPA=
s
processing
of
registration
applications
will
benefit
the
regulated
industry;
pesticide
users;
the
general
public;
other
federal,
state,
and
foreign
governments;
and
others
who
are
affected
by
or
interested
in
pesticide
use
or
regulation.

This
economic
analysis
estimates
the
incremental
change
in
costs
from
complying
with
the
40
CFR
158
data
requirements
as
codified
in
1984
(
the
"
baseline")
to
complying
with
data
requirements
under
the
proposed
changes.
Small
business
impacts
are
also
quantified.
Potential
benefits
of
the
proposed
changes
are
described.
To
estimate
costs
of
complying
with
the
data
requirements,
the
analysis
multiplies
the
estimated
cost
of
each
test
required
in
the
baseline
and
under
the
proposed
rule
with
the
probability
that
test
would
be
required.
The
probability
and
impacts
of
data
waivers
for
certain
data
requirements
are
accounted
for
in
the
cost
and
impact
calculations.
Because
there
is
variability
in
the
estimated
test
costs
across
laboratories
needed
to
generate
data
for
a
given
data
requirement,
the
analysis
uses
low,
average,
and
high
cost
estimates
for
each
data
requirement.
Agency
scientists
in
the
Biopesticides
and
Pollution
Prevention
Division
estimated
data
requirement
probabilities
for
the
baseline.

Biopesticide
registration
and
testing
activity
under
the
proposed
changes
to
40
CFR
158
were
estimated
based
on
a
historical
examination
of
registrations
of
new
biopesticide
active
ingredients
between
1997
and
2004.
These
registrations
capture
the
data
requirements
currently
imposed
by
the
Agency
on
a
case­
by­
case
basis
that
will
be
codified
in
the
proposed
changes
to
40
CFR
158.
Additional
effects
of
the
proposed
rule
due
to
newly
proposed,
revised,
or
modified
40
CFR
part
158
subparts
L&
M
data
requirements
were
estimated
based
on
EPA
experience
and
best
judgment.
Review
of
the
1997
to
2004
registration
activity
considered
the
type
of
biochemical
or
microbial
pesticide
that
was
registered,
the
frequency
of
registrations,
the
application
of
data
requirements
and
data
waivers
granted
by
EPA,
and
information
on
the
companies
submitting
the
registrations.
This
information
was
used
with
a
model
developed
by
the
Agency
to
estimate
the
impacts
of
the
proposed
rule
at
the
registration,
firm,
and
industry
levels.
6
Below
is
a
brief
summary
of
the
expected
impacts
of
the
proposed
rule
and
two
alternatives
considered.

Proposed
Rule:
Decision
Criteria
Determination
and
Likelihood
of
Data
Requirement
Waivers.
The
estimated
annual
impact
under
this
approach,
based
on
average
cost
estimates
per
test,
is
expected
to
result
in
a
regulatory
compliance
cost
reduction
of
approximately
$
3.04
million,
with
an
estimated
average
cost
savings
of
$
60,000
per
firm
per
year.
The
Agency
also
conducted
two
sensitivity
analyses
for
the
proposed
rule
impact
analysis
using
low
and
high
average
laboratory
cost
estimates
with
data
requirement
frequencies
as
estimated
for
the
proposed
rule.
The
high
cost
estimate
of
the
total
annual
impact
of
the
proposed
rule
is
a
cost
reduction
of
$
2.42
million,
and
the
low
cost
estimate
is
a
cost
reduction
of
$
3.65
million.
The
analysis
of
the
potential
impacts
of
the
proposed
rule
on
small
businesses
suggests
that
the
proposed
rule
will
directly
benefit
each
of
the
limited
number
of
small
entities
affected
because
all
of
the
potentially
impacted
firms
are
expected
to
experience
an
overall
total
cost
reduction.

Low­
cost
Alternative:
Waive
(
for
Biochemical
Pesticides)
and
Reduce
by
50%
(
for
Microbial
Pesticides)
Certain
Tier
I
Data
Requirements.
Under
this
alternative,
EPA
will
waive
all
nontarget
organism
and
environmental
fate
Tier
I
data
requirements
for
biochemical
pesticides
and
enact
a
50
percent
reduction
in
the
proposed
probabilities
for
non­
target
organism
and
environmental
fate
Tier
I
data
requirements
for
microbial
pesticides.
For
example,
if
a
proposed
probability
for
Avian
Oral
(
OPPTS
Guideline
No.
885.4050)
is
44
percent,
under
this
approach
it
will
be
22
percent.
The
estimated
annual
cost
reduction
under
this
alternative
approach
is
about
$
3.20
million,
with
an
estimated
average
cost
savings
of
$
63,000
per
firm
per
year.

High­
cost
Alternative:
Require
Tier
I
Data
Requirements
100%
of
the
Time:
Under
this
alternative,
EPA
will
require
Tier
I
data
100
percent
of
the
time
for
all
categories
of
data
requirements
and
for
all
biochemical
and
microbial
pesticide
registrations.
No
waivers
would
be
permissible
under
this
option.
The
estimated
annual
cost
increase
under
this
alternate
approach
is
about
$
3.44
million,
with
an
estimated
average
additional
cost
of
$
67,000
per
firm
per
year.

Since
the
likely
impact
of
the
proposed
rule
on
businesses
overall
is
expected
to
be
minimal
yet
beneficial,
the
Agency
believes
that
the
rule
will
have
no
effect
on
the
availability
of
pesticides
to
users.
On
balance,
the
Agency
believes
that
an
estimated
10
percent
average
cost
savings
per
firm
per
year
resulting
from
the
proposed
changes
to
40
CFR
part
158
subparts
L&
M
can
be
realized
without
compromising
the
protection
of
human
health
and
the
environment.
The
continued
practice
of
submission
and
granting
of
data
waivers
plays
an
important
role
in
the
economic
impact
of
the
proposed
changes,
with
data
requirement
costs
avoided
ranging
from
an
average
of
$
400,000
to
$
670,000
per
company
per
year,
based
on
low
and
high
test
cost
estimates
for
data
requirements
waived
for
registrants
of
biochemical
and
microbial
pesticides
between
1997
and
2004.
Costs
avoided
due
to
data
waivers
offset
the
increased
costs
due
to
the
proposed
changes
in
data
requirements
compared
to
the
baseline.
For
some
firms,
or
for
some
very
safe
biochemical
or
microbial
pesticides,
the
costs
avoided
could
be
much
greater.
This
may
be
important
from
an
environmental
standpoint,
because
the
money
and
time
saved
may
help
potentially
safer
pesticides
become
available
sooner,
and
may
help
them
compete
in
the
marketplace
with
pesticides
that
are
much
less
safe.
7
The
remainder
of
this
economic
analysis
contains
nine
additional
sections.
Section
2
contains
the
problem
statement,
which
includes
an
overview
of
biochemical
and
microbial
pesticide
usage,
exposure,
and
effects;
and
the
general
background
and
nature
of
the
proposed
rule.
Section
3
describes
the
regulatory
options
considered,
including
the
proposed
rule
and
two
alternatives.
Section
4
includes
an
industry
profile
of
the
biochemical
and
microbial
pesticide
registrant
universe.
Section
5
outlines
the
data
requirements
and
method
used
to
evaluate
the
economic
impacts
of
the
proposed
rule
and
alternatives 
including
a
quantitative
assessment
of
the
compliance
costs
and
qualitative
discussion
of
the
benefits.
Section
6
addresses
the
relative
impact
of
data
waivers
associated
with
the
proposed
data
requirements.
Section
7
illustrates
the
costs
and
benefits
comparison
between
the
proposed
rule
and
each
of
the
two
alternatives.
Section
8
uses
the
industry
profile
to
assess
the
small
business
impacts
of
the
proposed
rule.
Limitations
of
the
economic
analysis
are
discussed
in
Section
9.
Finally,
Section
10
presents
a
brief
overview
of
the
anticipated
burden
to
EPA
associated
with
the
proposed
rule.

2
PROBLEM
STATEMENT
2.1
Overview
of
Biochemical
and
Microbial
Pesticide
Usage,
Exposure,
and
Effects
At
the
end
of
2004,
there
were
approximately
200
registered
biochemical
pesticides
and
140
registered
microbial
pesticides.
Biochemical
and
microbial
pesticides
are
part
of
a
larger
class
of
pesticides
known
as
biopesticides,
which
are
certain
types
of
pesticides
derived
from
such
natural
materials
as
animals,
plants,
bacteria,
and
certain
minerals.
For
example,
canola
oil
and
baking
soda
have
pesticidal
applications
and
are
considered
biopesticides.
Biopesticides
are
usually
inherently
less
toxic
than
conventional
pesticides.
Biopesticides
generally
affect
only
the
target
pest
and
closely
related
organisms,
in
contrast
to
broad
spectrum,
conventional
pesticides
that
may
affect
organisms
as
different
as
birds,
insects,
and
mammals.
Biopesticides
often
are
effective
in
very
small
quantities
thereby
resulting
in
lower
exposures
and
largely
avoiding
the
pollution
problems
caused
by
conventional
pesticides.
When
used
as
a
component
of
Integrated
Pest
Management
(
IPM)
programs,
biopesticides
can
greatly
decrease
the
use
of
conventional
pesticides,
while
crop
yields
remain
high.

Biochemical
pesticides
include,
but
are
not
limited
to,
active
ingredients
such
as
semiochemicals
(
e.
g.,
pheromones
and
kairomones),
hormones
(
e.
g.,
natural
plant
and
insect
growth
regulators),
naturally­
occurring
repellents
and
attractants,
and
enzymes.
Because
of
low
use
volume,
minimal
toxicity,
and
a
nontoxic
mode
of
action,
among
other
criteria,
biochemical
pesticides
are
presumed
to
pose
less
risk
to
humans
and
the
environment
than
conventional
pesticides.
Therefore,
a
valid
risk
assessment
can
be
performed
for
chemicals
meeting
the
definition
of
"
biochemical"
with
less
chemical­
specific
information
on
potential
hazards
and
exposure
than
would
be
necessary
for
an
assessment
of
a
conventional
pesticide.

It
is
important
to
note
that
not
all
biochemicals
are
naturally
occurring.
A
synthetic
active
ingredient
can
be
classified
as
a
biochemical
if
it
is
structurally
similar
and
functionally
identical
to
a
naturally
occurring
substance.
An
example
of
a
synthetic
product
that
meets
the
criteria
for
classification
as
a
biochemical
pesticide
is
an
insect
pheromone
manufactured
in
a
laboratory.
They
are
structurally
and
functionally
identical
to
the
substances
that
are
produced
by
the
insects,
but
they
are
not
naturally
occurring.
In
regard
to
the
second
criterion,
the
"
natural
occurrence"
of
8
a
substance
does
not
immediately
imply
that
it
has
a
non­
toxic
mode
of
action.
An
example
of
a
substance
in
this
category
would
be
pyrethrum,
a
natural
insecticide
obtained
from
certain
chrysanthemum
flowers
that
is
known
to
be
a
very
potent
neurotoxin.
This
toxic
mode
of
action
would
preclude
pyrethrum
from
being
classified
as
a
biochemical.
Another
factor
that
is
considered
in
determining
if
a
pesticide
is
a
biochemical
is
that
a
non­
toxic
mode
of
action
against
the
target
pest
does
not
presume
a
lack
of
toxicity
to
humans
and
non­
target
organisms.
All
substances
must
be
reviewed
and
assessed
for
their
potential
to
cause
human
dermal
or
eye
irritation,
sensitization,
or
the
likelihood
of
toxicity
via
the
inhalation
route
of
exposure.
The
potential
for
subchronic
and
chronic
effects
must
also
be
considered.
If
there
is
a
potential
for
human
toxicity,
there
may
be
analogous
effects
on
non­
target
organisms.

Microbial
pesticides
are
living
entities
capable
of
survival,
growth,
reproduction,
and
infection.
Microbial
pesticides
are
microbial
entities
that
function
as
pesticides,
including
agricultural
bacteria,
fungi,
viruses,
and
protozoans.
The
data
requirements
apply
to
all
microbial
pesticides.
This
includes
those
that
are
naturally­
occurring
and
those
that
are
genetically
modified,
including
plant­
incorporated
protectants
(
PIPs).
The
Agency
intends
to
propose
data
requirements
for
PIPs
in
a
separate
rulemaking
activity
in
the
future.
Each
new
variety,
subspecies,
or
strain
of
an
already
registered
microbial
pest
control
agent
is
a
separate
active
ingredient
that
must
be
evaluated
and
may
be
subject
to
additional
data
requirements.

2.2
Nature
of
Market
Failures
Inherent
from
Pesticide
Producer
and
User
Behavior
Economic
theory
suggests
that
regulatory
intervention
is
justified
in
the
presence
of
market
failures.
For
example,
in
the
case
of
pesticide
residues
on
food,
the
two
most
salient
sources
of
failure
are
externalities
and
asymmetric
information.
Externalities
arise
because
some
of
the
costs
(
e.
g.
groundwater
contamination
and
environmental
damage)
associated
with
pesticide
residues
are
external
to
those
benefiting
from
the
pesticides
(
pesticide
producers
and
users,
and
consumers
of
food).
The
asymmetric
information
problem
arises
because
consumers
cannot
easily
determine
the
level
of
pesticide
residue
on
food.
Even
if
the
level
were
readily
apparent,
the
nature
of
the
risks
posed
by
these
residues
is
not
well
understood.
For
pesticides,
regulatory
intervention
is
needed
to
ensure
that
large
external
costs,
potentially
outweighing
the
benefits
of
pesticide
use,
are
not
being
generated,
and
to
make
information
about
pesticide
risks
available
to
potentially
affected
parties.

2.3
Overview
of
the
Proposed
Rule
EPA
is
proposing
to
change
data
requirements
for
the
registration
of
biochemical
and
microbial
pesticide
products
that
are
listed
in
40
CFR
part
158.
The
regulations
governing
data
requirements
have
not
been
comprehensively
revised
since
1984.
Since
then
the
information
generally
needed
to
support
the
registration
of
a
biochemical
or
microbial
pesticide
has
expanded
or
has
been
refined
as
experience
with
pesticides
and
the
science
underlying
the
data
requirements
has
advanced.
Further,
as
a
result
of
the
Food
Quality
Protection
Act
(
FQPA)
of
1996,
EPA
must
now
address
additional
human
health
risk
issues
associated
with
the
use
of
pesticides,
such
as
aggregate
and
cumulative
risk.
Additional
data
are
required
to
perform
these
assessments.
9
Organizational
changes
in
the
proposed
rule
include
expanding
the
number
of
subparts.
Currently
40
CFR
part
158
is
divided
into
four
subparts:

1.
Subpart
A,
General
Provisions;
2.
Subpart
B,
How
to
Use
Data
Tables;
3.
Subpart
C,
Product
Chemistry
Data
Requirements;
and
4.
Subpart
D,
Data
Requirements
Tables.

As
indicated
in
the
proposed
rule
for
conventional
pesticides
(
70
FR
12276,
March
11,
2005),
EPA
is
proposing
to
reorganize
40
CFR
part
158
to
more
closely
correspond
with
the
Office
of
Prevention,
Pesticides,
and
Toxic
Substances
(
OPPTS)
Harmonized
Guidelines,
primarily
by
creating
a
series
of
new
subparts
to
replace
subpart
D
(
see
Table
2­
1).
Each
subpart
will
address
an
individual
scientific
discipline
or
data
type.
As
a
result,
the
following
two
subparts
were
created:

°
Biochemical
pesticides
are
being
proposed
as
40
CFR
part
158
subpart
L;
and
°
Microbial
pesticides
are
proposed
as
40
CFR
part
158
subpart
M.

Table
2­
1:
Cross
Reference
Between
Current
and
Proposed
40
CFR
Part
158
Subparts
Current
Regulation
and
Title
Proposed
Regulation
and
Title
Subpart
D:
§
158.690
Subpart
L:
§
158.900
Biochemical
Pesticides
Subpart
D:
§
158.740
Subpart
M:
§
158.1000
Microbial
Pesticides
The
data
requirements
specified
in
40
CFR
part
158
subparts
L&
M
are
intended
to
provide
EPA
with
data
and
other
information
generally
necessary
for
the
registration
of
both
manufacturing­
use
and
end­
use
biochemical
or
microbial
pesticide
products.
It
does
not
include
data
requirements
for
conventional
pesticides,
antimicrobial
pesticides,
or
changes
to
existing
spray
drift
data
requirements.

The
proposed
revisions
are
expected
to
improve
EPA=
s
ability
to
make
timely
decisions
about
the
likely
human
health
and
environmental
effects
of
biochemical
and
microbial
pesticide
products.
These
new
data
requirements
are
intended
to
help
EPA
better
protect
people
(
including
sensitive
populations),
wildlife,
and
the
environment.
Coupled
with
revising
data
requirements,
EPA
proposes
to
reformat
the
tables
and
make
some
revisions
to
its
general
procedures
and
policies
associated
with
data
submission.
EPA
believes
that
the
proposed
changes
to
these
regulations
will
provide
the
biopesticide
industry
and
other
partners
in
the
regulated
community
with
a
better
understanding
of
the
biochemical
and
microbial
pesticide
data
requirements
and
allow
them
to
better
prepare
for
the
pesticide
registration
process,
thus
reducing
delays.
In
addition,
the
newly
codified
40
CFR
part
158
subparts
L&
M
would
also
clarify
the
types
of
data
waivers
acceptable
and
likely
to
be
accepted
in
order
to
expedite
the
registration
process
for
these
types
of
biopesticides,
which
have
an
inherently
lower
risk
than
conventional
pesticides.
10
2.4
Statutory
Authority
for
the
Proposed
Rule
Two
primary
statutes
provide
EPA
the
authority
to
regulate
pesticides 
the
Federal
Insecticide,
Fungicide,
and
Rodenticide
Act
(
FIFRA)
and
the
Federal
Food,
Drug,
and
Cosmetic
Act
(
FFDCA).
The
Food
Quality
Protection
Act
(
FQPA)
amended
both
FIFRA
and
FFDCA.

Federal
Insecticide,
Fungicide,
and
Rodenticide
Act
(
FIFRA)

As
the
standard
for
registration
of
a
pesticide,
FIFRA
section
3(
c)(
5)
requires,
among
other
things,
that
a
pesticide,
when
used
in
accordance
with
widespread
and
commonly
recognized
practices,
will
not
generally
cause
unreasonable
adverse
effects
on
the
environment.
FIFRA
section
2(
bb)
defines
"
unreasonable
adverse
effects
on
the
environment"
as
"(
1)
any
unreasonable
risk
to
man
or
the
environment,
taking
into
account
the
economic,
social,
and
environmental
costs
and
benefits
of
the
use
of
any
pesticide,
or
(
2)
a
human
dietary
risk
from
residues
that
result
from
a
use
of
a
pesticide
in
or
on
any
food
inconsistent
with
the
standard
under
section
408
of
the
Federal
Food,
Drug,
and
Cosmetic
Act
(
21
U.
S.
C.
''
346a)."
This
standard
also
applies
to
the
reregistration
of
existing
pesticide
products
under
section
4,
and
Agency
approval
of
any
experimental
use
of
unregistered
pesticides
under
section
5.

FIFRA
is
a
licensing
statute,
under
which
regulatory
decisions
on
the
registrability
of
an
individual
product
are
based
upon
data
specific
to
the
product
and
its
uses.
EPA
is
authorized
to
require
the
submission
of
data
it
needs
to
make
the
registration
decision
in
the
context
of
any
individual
application
for
registration,
amended
registration,
or
reregistration.
EPA
may
also
impose
a
data
requirement
after
registration
in
order
to
maintain
the
registration,
using
specific
Data
Call­
In
authority
of
FIFRA
section
3(
c)(
2)(
B).

In
order
for
the
Agency
to
make
registration
decisions,
FIFRA
section
3(
c)(
2)
gives
EPA
broad
authority,
before
and
after
registration,
to
require
specific
testing
by
registrants
and
applicants
and
submission
of
the
resulting
data
to
the
Agency
(
7
U.
S.
C.
''
136a­
c).
40
CFR
Part
158
L&
M
sets
forth
general
requirements
for
data
submission.
Also,
on
a
case­
by­
case
basis,
EPA
has
exercised
authority
to
require
data
in
addition
to
that
specified
in
40
CFR
part
158
and
has
consistently
granted
waivers
for
certain
data
requirements,
depending
on
the
type
of
pesticide.
Registrants
and
applicants
are
under
a
continuing
obligation
to
provide
EPA
with
adequate
information
about
their
products
to
demonstrate
that
the
products
meet
the
statutory
standard
for
registration.

Federal
Food,
Drug
and
Cosmetic
Act
(
FFDCA)

In
addition
to
the
requirements
of
FIFRA,
FFDCA
section
408,
requires
that
any
pesticide
whose
use
may
result,
directly
or
indirectly,
in
residues
on
food
(
including
animal
feed)
must
have
a
tolerance
(
maximum
legal
residue
level)
or
an
exemption
from
tolerance.
A
tolerance
(
or
exemption)
is
needed
for
residues
of
all
ingredients
in
a
pesticide
product,
both
active
and
inert,
as
well
as
any
transformation
products
(
i.
e.,
metabolites
and/
or
degradates)
of
the
pesticide
chemical.
A
food
that
bears
residues
not
covered
by
a
tolerance
or
exemption
is
considered
adulterated
under
FFDCA,
may
not
be
shipped
in
interstate
commerce,
and
is
subject
to
seizure.
11
Food
Quality
Protection
Act
(
FQPA)

On
August
3,
1996,
FQPA
was
enacted,
amending
both
FIFRA
and
FFDCA.
The
new
standard
for
establishing
a
tolerance
or
exemption
under
FFDCA
section
408(
b)
is
that
pesticide
residues
must
conform
to
a
Areasonable
certainty
of
no
harm"
standard
with
respect
to
the
general
population,
and
to
infants
and
children
specifically.
To
determine
whether
a
tolerance
meets
this
standard,
EPA
must
take
into
account
aggregate
exposure
to
the
pesticide
chemical
residue,
(
dietary,
non­
dietary,
and
non­
occupational
exposure),
cumulative
risks
from
multiple
related
chemicals
with
a
common
mode
of
action,
and
other
factors
enumerated
in
section
408(
b)(
2)(
C)
for
infants
and
children
and
in
section
408(
b)(
2)(
D).

FFDCA
section
408(
b)(
2)(
A)(
ii)
calls
for
additional
scientific
analyses,
which
have
not
routinely
been
a
part
of
the
Agency=
s
risk
assessment
procedures,
such
as
evaluating
multiple
pathway
aggregate
exposures
from
dietary
and
non­
dietary
sources.
Although
this
provision
is
primarily
directed
at
food­
use
pesticides,
the
Agency
may
apply
a
similar
approach
to
actions
involving
non­
dietary­
use
pesticides
that
may
pose
significant
non­
dietary
risks
to
children.

2.5
Description
of
the
Proposed
Rule
Data
Requirements
The
40
CFR
part
158
subparts
L&
M
data
requirements
for
biochemical
and
microbial
pesticide
registrations
are
organized
by
data
category
(
data
discipline).
The
specific
data
required
within
each
data
category
depends
primarily
on
the
exposure
presented
and
toxic
characteristics
of
the
biochemical
or
microbial
pesticide.

Data
Requirements
by
Data
Category
(
Data
Discipline)

When
an
applicant
applies
for
registration
of
a
biochemical
or
microbial
pesticide
product,
the
applicant
must
submit
data
in
support
of
that
registration
application.
The
following
seven
categories
of
data
may
be
required
(
see
Table
2­
2),
depending
on
the
type
of
product
being
registered.
The
tests
are
generally
performed
on
the
active
ingredient,
but
may
also
be
necessary
for
formulated
products.
12
Table
2­
2:
Data
Categories
and
Descriptions
Data
Category
Description
Toxicology
1
Tests
of
acute,
subchronic,
and
chronic
toxicity
and
other
human
health
concerns,
such
as
carcinogenicity,
may
be
required
to
determine
whether
the
product
may
pose
a
hazard
to
humans.
Human
Exposure
1
Because
people
may
be
exposed
to
the
product
both
during
application
of
the
product
and
after
application,
information
about
possible
oral,
dermal,
and
inhalation
exposure
as
well
as
information
on
how
the
product
is
used
are
required
for
registration.
Residue
Chemistry
To
determine
whether
the
chemical
may
be
found
in
plants,
livestock,
and
fish
that
may
be
used
for
food,
a
variety
of
information
is
required,
including
a
proposed
tolerance
in
food.
Product
Chemistry
Tests
of
product
identity
and
composition,
delineation
of
methods
of
analysis,
and
tests
of
physical
and
chemical
properties
are
required
to
characterize
the
product.
Ecological
Effects
2
Tests
of
the
effects
of
the
active
ingredient
or
a
typical
pesticide
product
on
aquatic
and
terrestrial
vertebrates,
invertebrates,
and
plants
are
required
to
determine
whether
the
product
poses
an
ecological
risk
to
organisms
that
may
come
in
contact
with
the
product.
Environmental
Fate
2
Information
on
a
pesticide
>

s
transport
and
dissipation
in
water,
air,
and
soil
may
be
required
to
determine
whether
the
components
of
the
product
persist
in
the
environment
and
where
it
is
likely
to
concentrate.
Non­
target
Organisms
2
Testing
of
a
pesticide
=

s
effects
on
non­
target
terrestrial
and
aquatic
plant
and
animal
species
may
be
required
on
organisms
of
concern
including
crop
plants
or
non­
target
plants
and
insects.
1.
Biochemical
data
requirements
in
proposed
rule
refer
to
Toxicology
and
Human
Exposure
as
"
Human
Health
Assessment".
Microbial
data
tables
only
contain
Toxicology
data
requirements.
2.
Proposed
rule
refers
to
Ecological
Effects,
Environmental
Fate,
and
Non­
target
Organisms
as
"
Non­
target
Organisms
and
Environmental
Fate"

Data
Requirements
by
Type
of
Registration
Action
Data
requirements
are
generally
levied
as
a
result
of
a
potential
registration
action.
They
usually
differ
depending
on
the
type
of
registration
being
sought
(
e.
g.,
whether
the
product
contains
an
active
ingredient
not
previously
registered
or
whether
the
pesticide
is
identical
to
or
substantially
similar
to
an
existing
product).
The
types
of
registration
that
generally
trigger
data
requirements
are
grouped
in
the
following
categories
(
see
Table
2­
3):

Table
2­
3:
Types
of
Registration
Actions
and
Descriptions
Type
of
Registration
Description
New
Active
Ingredient
An
application
for
registration
of
a
new
product
that
contains
an
active
ingredient
that
is
not
included
in
any
currently
registered
product.
Major
New
Use
An
application
for
a
new
product
that
includes
the
addition
of
a
use
pattern
that
is
not
currently
registered
for
one
or
more
active
ingredient(
s)
contained
in
the
product.
The
proposed
use
pattern
is
significantly
different
from
any
pattern
registered
for
an
existing
use.
Major
New
Use
Amendment
An
amendment
of
a
registration
of
a
product
that
includes
the
addition
of
a
use
pattern
that
is
not
currently
registered
for
one
or
more
active
ingredient(
s)
contained
in
the
product.
The
proposed
use
pattern
is
significantly
different
from
any
pattern
registered
for
an
existing
use.
13
2.6
Types
of
Data
Requirement
Changes
in
the
Proposed
Rule
Since
1984,
when
40
CFR
part
158
was
first
promulgated,
EPA=
s
data
requirements
have
evolved
along
with
the
general
scientific
understanding
of
the
potential
hazards
posed
by
pesticides.
In
the
proposed
rule,
EPA
is
proposing
new
and
revised
data
requirements
that
encompass
three
categories
of
requirements:

1.
EPA
is
proposing
Anew
requirements,@
never
before
imposed
on
any
registrant.
2.
EPA
is
proposing
Anewly
codified
requirements,@
which
have
been
applied
on
a
caseby
case
basis,
but
are
not
contained
in
the
CFR.
3.
EPA
is
proposing
revisions
to
Aexisting
requirements.@

Most
of
the
data
requirements
contained
in
the
proposed
rule
have
been
applied
on
a
case­
by­
case
basis
to
support
individual
applications.
Some
of
the
changes
are
clarifications
or
housekeeping
changes
without
cost
or
burden,
others
have
the
effect
of
increasing
or
decreasing
the
burden
of
the
data
requirement.
The
types
of
changes
may
be
broadly
categorized
as
follows:

Potentially
Substantive
Changes
°
Addition
of
a
requirement.
°
Elimination
of
a
requirement,
sometimes
with
substitution
of
a
new
requirement.
For
example,
the
hypersensitivity
study
to
support
registration
of
biochemicals
would
be
eliminated,
and
the
dermal
sensitization
study
is
proposed
to
be
required
to
address
the
same
endpoints
of
concern
for
toxicity
and
more
appropriate
for
the
current
methodology.
°
A
change
in
the
conditional
nature
of
the
test
requirement.
EPA
is
proposing
to
change
a
number
of
requirements
from
conditionally
required
to
fully
required,
or
vice
versa.
For
example,
the
90­
day
oral
study
is
currently
conditionally
required
(
CR)
for
all
food
uses.
EPA
proposes
to
fully
require
(
R)
this
data
for
all
food
uses.
°
A
change
to
the
use
patterns
to
which
a
data
requirement
applies.
For
example,
the
nature
of
the
residue
in
plants
and
livestock
is
currently
not
required
for
indoor
uses.
EPA
proposes
to
conditionally
require
(
CR)
this
data
for
indoor
food
uses.
°
A
change
to
the
test
substance
to
be
used.
For
example,
EPA
proposes
to
require
the
enforcement
analytical
method
to
be
tested
with
technical
grade
active
ingredient
(
TGAI),
in
lieu
of
the
current
manufacturing­
use
products
(
MP)
and
end­
use
products
(
EP)
for
biochemical
pesticides.
°
A
clarification
in
the
notes
describing
the
test.
For
example,
EPA
has
historically
required
minimal
data
to
support
registration
of
Straight
Chain
Lepidopteran
Pheromones
(
SCLPs).
EPA
is
proposing
to
codify
this
trend
by
triggering
data
requirements
for
SCLPs
only
if
the
SCLP
is
applied
at
a
rate
greater
than
150
grams
active
ingredient/
acre/
year.
This
is
specified
in
exemptions
in
40
CFR
180.1153,
where
lepidopteran
pheromones
are
exempt
from
certain
data
requirements.
EPA
proposes
to
include
these
same
criteria
in
a
test
note
of
the
data
table.
14
Technical
Changes
Having
No
Substantive
Effect
Technical
changes
include
the
relocation
of
a
data
requirement,
a
change
to
the
title
of
a
data
requirement,
subdividing
an
existing
requirement
to
create
two
separate
entries,
and
merging
two
data
requirements
into
a
single
entry.
These
changes
would
not
increase
or
decrease
the
burden
of
the
data
requirement.

Revisions
to
Use
Patterns
The
current
regulation
lists
individual
use
patterns
for
biochemical
and
microbial
pesticides,
i.
e.
indoor
and
outdoor
uses,
food
and
nonfood,
etc.
(
40
CFR
part
158
subpart
D).
In
the
Agency's
proposal
of
the
data
requirements
for
conventional
pesticides,
there
was
an
expansion
of
uses.
For
biochemical
and
microbial
pesticides,
the
Agency
proposes
the
use
patterns
to
be
inclusive
in
some
cases,
so
that
certain
data
are
required
for
all
use
patterns
(
i.
e.,
product
chemistry
for
biochemical
pesticides),
and,
in
other
cases,
it
is
proposing
an
expansion
(
i.
e.,
non­
target
organism
and
environmental
fate
for
microbial
pesticides).
The
proposed
use
pattern
revisions
are
based
on
the
past
registration
activities
as
well
as
the
data
requirements
that
have
been
identified
as
the
science
has
evolved.
Along
with
the
revisions
to
the
data
requirements
for
biochemical
and
microbial
pesticides,
where
applicable,
the
Agency
proposes
to
update
the
use
patterns
specified
in
the
data
tables
to
coincide
with
part
158
subpart
B
section
158.100
(
70
FR
12276;
March
11,
2005).

°
Food
use
includes:
terrestrial
food
crop
use,
terrestrial
feed
crop
use,
aquatic
food
crop
use,
greenhouse
food
crop
use,
and
indoor
food
use.
 
Non­
food
use
includes:
terrestrial
non­
food
crop
use,
aquatic
non­
food
residential
use,
aquatic
nonfood
outdoor
use,
aquatic
non­
food
industrial
use,
aquatic
non­
food
industrial,
greenhouse
non­
food
crop
use,
forestry
use,
residential
outdoor
non­
food
use,
residential
indoor
non­
food
use,
terrestrial
industrial
use
(
for
microbials),
and
indoor
non­
food
use.

However,
with
respect
to
biochemical
pesticide
data
requirements,
there
are
six
general
use
groups
identified
for
non­
target
organisms,
fate,
and
expression
(
i.
e.,
more
than
non­
food
or
food
use
categories).
The
proposed
non­
target
organism
data
table
for
biochemical
pesticide
requires
five
general
use
groups,
with
no
distinction
between
food
and
nonfood.
With
respect
to
microbial
pesticides,
there
are
nine
current
use
categories
for
non­
target
species.
The
Agency
is
proposing
to
decrease
the
use
categories
to
eight.

3
ALTERNATIVE
OPTIONS
TO
THE
PROPOSED
RULE
In
addition
to
the
proposed
rule
data
requirements
discussed
in
Section
2,
EPA
considered
two
alternative
approaches
for
addressing
40
CFR
part
158
subparts
L&
M
proposed
data
requirements.
Subsections
3.1
and
3.2
below
describe
each
alternative
separately.
15
3.1
Low­
cost
Alternative:
Waive
and
Reduce
Certain
Proposed
Tier
I
Data
Requirements
Under
this
alternative,
the
Agency
would
waive
all
non­
target
organism
and
environmental
fate
Tier
I
data
requirements
for
biochemical
pesticides.
Additionally,
the
Agency
would
enact
a
50
percent
reduction
in
the
proposed
probabilities
for
non­
target
organism
and
environmental
fate
Tier
I
data
requirements
for
microbial
pesticides.
For
example,
if
a
proposed
probability
for
Avian
Oral
(
OPPTS
Guideline
No.
885.4050)
is
44
percent,
under
this
approach
it
will
be
22
percent.
This
alternative
approach
provides
additional
data
requirement
relief
beyond
the
expected
number
and
types
of
waivers
issued
under
the
proposed
option.

3.2
High­
cost
Alternative:
Require
Proposed
Tier
I
Data
Requirements
100%
of
the
Time
Under
this
alternative,
EPA
would
require
Tier
I
data
100
percent
of
the
time
for
all
categories
of
data
requirements
and
for
all
biochemical
and
microbial
pesticide
registrations.
No
waivers
would
be
permissible
under
this
option
to
allow
the
Agency
access
to
the
greatest
amount
of
information
required
for
reviewing
biochemical
and
microbial
pesticide
registration
actions.
This
alternative
approach
would
result
in
added
costs
to
pesticide
registrants
and
increase
the
registration
data
review
burden
to
the
Agency
than
the
proposed
approach,
but
would
ensure
availability
of
all
test
result
information.

4
INDUSTRY
PROFILE
OF
THE
REGULATED
COMMUNITY
Profiling
the
biochemical
and
microbial
pesticide
industry
is
necessary
to
assess
the
impacts
of
the
proposed
rule
and
alternatives
on
affected
firms 
particularly
small
businesses.
The
industry
profile
analysis
of
the
regulated
community
is
described
here
followed
by
a
more
targeted
analysis
of
impacts
on
small
businesses
(
discussed
later
in
detail
in
Section
8).

The
market
structure
of
the
basic
producing
industry
can
be
described
as
a
moderately
to
highly
concentrated
oligopoly,
with
only
about
20
basic
producers
of
common
U.
S.
pesticides.
Relatively
few
firms
produce
the
bulk
of
product,
and
a
few
products
tend
to
dominate
national,
regional,
and
local
markets
for
individual
site/
pest
combinations.
Individual
firms
tend
to
significantly
influence
supply
and
prices
in
the
markets
in
which
they
compete.

4.1
Biochemical
and
Microbial
Pesticide
Registrant
Universe
The
Pesticide
Regulatory
Action
Tracking
System
(
PRATS)
is
used
by
EPA
to
track
and
manage
registration
activities.
Each
registration
action
is
assigned
an
action
code
that
defines
the
specific
type
of
registration
action.
The
PRATS
database
provides
a
list
of
pesticide
registration
actions
submitted
by
each
applicant
or
registrant,
including
the
dates
for
applications
received
by
EPA
and
when
the
Agency
responded
to
each
application.
For
this
analysis,
the
Agency
used
a
subset
of
the
PRATS
data
set
relevant
to
40
CFR
part
158
data
requirements
submitted
for
biochemical
and
microbial
pesticides
from
1997
through
2004.
16
Since
the
PRATS
database
contains
historical
data,
it
is
a
sound
indicator
of
the
types
of
entities
that
undertook
registration
actions.
However,
the
PRATS
population
may
not
be
representative
of
the
registrant
universe
that
will
undertake
registration
actions
in
the
future
since
it
only
captures
entities
that
have
made
requests
during
the
sample
time
period.
Other
entities
may,
of
course,
do
so
in
the
future.
Therefore,
EPA
also
compiled
a
profile
of
the
larger
population
of
biochemical
and
microbial
pesticide
registrants
with
active
registrations
from
the
Office
of
Pesticide
Programs
Information
Network
(
OPPIN),
some
of
which
conceivably
will
undertake
registration
actions
in
the
future.

The
OPPIN
database
was
queried
in
Spring
2005
for
all
companies
having
one
or
more
Section
3
or
Section
24(
c)
(
state)
biochemical
or
microbial
registrations.
There
were
247
entries
in
the
OPPIN
database
for
companies
that
registered
biopesticides.
Companies
with
unique
EPA
company
numbers
in
the
OPPIN
database
were
consolidated
based
on
the
following
criteria:
(
1)
matching
EPA
company
numbers
with
D&
B
DUNS
and
ultimate
parent
DUNS
numbers;
(
2)
results
of
recent
mergers
and
acquisitions;
and
(
3)
matching
company
names
associated
with
unique
EPA
company
numbers
to
be
consolidated
based
on
nearly
identical
name
matching
and/
or
prior
knowledge.
As
a
result
of
this
matching,
181
separate
companies
were
found
to
have
registered
biochemical
pesticides,
and
57
companies
registered
microbial
pesticides.

4.2
Registrant
Financial
Data
Neither
PRATS
nor
OPPIN
contains
information
on
the
size
or
financial
characteristics
of
the
entities.
Therefore,
it
was
necessary
to
collect
data
from
an
additional
source.
EPA
used
the
Dun
and
Bradstreet
(
D&
B)
Market
Spectrum
database
to
obtain
firm
size
and
financial
data
for
our
analysis
of
the
impacts
of
the
proposed
rule
on
individual
entities.
D&
B
is
a
comprehensive
source
of
financial
information
on
entities,
including
firm
locations,
sales,
and
primary
business
classifications
under
North
American
Industrial
Classification
System
code
(
NAICS).

In
order
to
link
entities
in
the
PRATS
and
OPPIN
data
sets
with
the
D&
B
database,
EPA
identified
each
entity=
s
Data
Universal
Numbering
System
(
DUNS)
number.
The
D&
B
DUNS
number
is
a
unique
identifier
for
a
business
entity,
which
can
also
be
linked
to
the
corporate
family
structure.

EPA
used
the
DUNS
number
for
each
firm
to
query
the
D&
B
database
to
retrieve
the
ultimate
parent
firm
name,
as
well
as
the
ultimate
parent
firm=
s
annual
revenue,
total
number
of
employees,
and
primary
NAICS
code.
The
ultimate
parent
firm
is
defined
as
a
corporation
that
owns
more
than
50
percent
of
another
corporation.
The
parent
firm
may
also
be
a
subsidiary
of
another
corporation.
All
financial
information
in
this
profile
is
summarized
at
the
global
ultimate
parent­
firm
level.
The
global
ultimate
parent
is
the
highest
level
within
the
firm=
s
structure.
EPA
evaluated
the
impacts
of
the
proposed
rule
at
this
corporate
level.

Revenue
(
or
sales
volume)
and
number
of
employees
are
two
reported
values
necessary
to
determine
a
company's
Small
Business
Administration
(
SBA)
size
classification.
SBA
size
definitions
depend
on
a
company's
NAICS
code.
D&
B
data
includes
revenue
and
number
of
employees
for
most
companies
in
the
United
States.
Information
on
employees
and
sales
was
obtained
from
the
infoUSA.
com
Business
Sales
Leads
database
for
six
companies
that
could
not
be
found
in
D&
B
Market
Spectrum.
17
Out
of
the
247
company
entries
initially
considered
in
the
biochemical
and
microbial
industry
profile
universe,
sales
and
revenue
data
could
not
be
found
for
26
companies
through
D&
B,
infoUSA.
com,
and
an
Internet
search.
The
remaining
221
entries
were
found
to
have
200
separate
parent
companies
(
i.
e.,
global
ultimate
DUNS
numbers).
One
of
these,
the
USDA
Forest
Service,
is
a
government­
related
entity.
This
leaves
a
total
of
199
unique
parent
companies
(
81
percent
of
total)
with
sufficient
data
available
to
be
classified
as
either
small
or
large
businesses
according
to
the
SBA
company
size
definitions.

In
addition,
D&
B
reports
the
6­
digit
NAICS
code
for
each
firm.
The
less
refined
3­
digit
NAICS
code,
which
is
derived
from
the
6­
digit
code,
is
more
useful
in
summarizing
the
types
of
businesses
included
in
the
data
set.
Table
4­
1
shows
that
46
percent
of
the
parent
entities
from
the
OPPIN
data
set
are
primarily
identified
as
Chemical
Manufacturing
(
NAICS
325).
Some
subsectors
represented
in
this
population
are:

°
Pesticide
and
other
agricultural
chemical
manufacturing
(
325320);
°
Pharmaceutical
preparation
manufacturing
(
325412);
and
°
All
other
basic
inorganic
chemical
manufacturing
(
325199).

Table
4­
1:
Primary
Industry
Sectors
Represented
in
the
OPPIN
Data
Set
NAICS
Code1
Sector
Description
Number
of
Parent
Companies2
325
Chemical
Manufacturing
88
424
Merchant
Wholesalers,
Nondurable
Goods
43
541
Professional,
Scientific
and
Technical
Services
12
423
Merchant
Wholesalers,
Durable
Goods
6
311
Food
Manufacturing
5
561
Administrative
and
Support
Services
5
339
Miscellaneous
Manufacturing
4
332
Fabricated
Metal
Product
Manufacturing
3
111
Crop
Production
3
115
Support
Activities
for
Agriculture
and
Forestry
3
453
Miscellaneous
Store
Retailers
3
531
Real
Estate
and
Rental
Leasing
3
Others
21
Total
199
Source:
OPPIN,
2005;
Dun
&
Bradstreet,
2005.
1
Government
entities
are
excluded
from
the
analysis.
2
The
twelve
companies
with
D&
B
data
but
no
NAICS
code
were
assumed
to
be
associated
with
NAICS
code
325320,
Pesticide
and
Other
Agricultural
Chemical
Manufacturing,
for
the
analysis.

5
ECONOMIC
IMPACTS
ON
PESTICIDE
REGISTRANTS
DUE
TO
CHANGES
IN
DATA
REQUIREMENTS
This
section
describes
the
data
requirements
and
method
used
to
quantitatively
assess
the
incremental
cost
of
compliance
with
the
proposed
rule
(
described
in
Section
2)
and
the
two
18
alternative
options
(
described
in
Section
3).
The
impacts
of
data
waivers
submitted
and
granted
for
biochemical
and
microbial
pesticides
are
relevant
to
the
overall
economic
impacts
of
the
changes
in
data
requirements
and
are
addressed
in
the
next
section
(
Section
6).
The
benefits
of
the
proposed
rule
and
alternative
options
are
difficult
to
quantify
and
monetize.
These
effects
are
described
in
Section
7,
along
with
a
summary
and
comparison
of
the
costs
and
benefits
of
the
proposed
rule
and
alternative
options
considered.

Compliance
costs
of
the
proposed
data
requirements
for
40
CFR
part
158
subparts
L&
M
were
compared
to
a
baseline
as
defined
as
the
data
requirements
established
in
the
1984
final
rule,
i.
e.,
the
cost
of
compliance
with
the
relevant
data
requirements
codified
in
40
CFR
Part
158
subpart
D.
Variations
in
compliance
costs
were
estimated
for
the
two
alternative
options
for
comparison.
The
number
of
biochemical
and
microbial
registrations
and
the
frequency
of
specific
tests
performed
to
meet
relevant
data
requirements
per
year
were
based
on
EPA
analysis
of
registration
activity
that
occurred
between
1997
and
2004.
The
incremental
cost
of
data
requirements
for
each
registration
action
due
to
the
proposed
changes
was
then
multiplied
by
the
average
annual
number
of
registration
actions,
in
order
to
estimate
the
expected
total
industry
impact
and
the
impacts
per
firm.
The
impact
of
data
waivers
was
also
estimated
based
on
EPA's
recent
experience
with
reviewing
biochemical
and
microbial
pesticide
registration
applications
between
1997
and
2004
(
see
Section
6).
This
economic
impact
analysis
was
done
in
the
following
six
steps:

Step
1.
Determine
the
unit
test
costs
of
each
data
requirement
Step
2.
Determine
the
data
requirements
per
biochemical
and
microbial
pesticide
registration
action
Step
3.
Determine
the
incremental
costs
and
impact
of
waivers
per
registration
action
Step
4.
Determine
the
incremental
industry­
wide
impacts
Step
5.
Determine
the
incremental
impact
per
firm
Step
6.
Profile
the
affected
industry
and
determine
the
incremental
impact
per
small
firm
as
a
percent
of
sales
Chart
5­
1
illustrates
the
economic
analysis
methodology.
Steps
1
through
5
are
described
in
this
and
the
following
sections.
Step
6
of
the
economic
analysis,
which
assesses
the
impacts
of
the
proposed
rule,
is
described
in
Section
8.
The
unit
test
costs
(
Step
1)
are
multiplied
by
the
data
requirements
(
Step
2)
for
both
the
baseline
and
proposed
rule
to
estimate
the
estimated
total
cost
per
biochemical
and
microbial
registration
(
Step
3).
The
incremental
test
costs
and
impact
of
waivers
per
registration
action
are
the
difference
in
the
total
costs
per
biochemical
and
microbial
registrations
between
the
baseline
and
the
proposed
rule.
The
incremental
costs
per
registration
action
are
multiplied
by
the
number
of
registration
actions
for
the
industry
to
get
the
industrywide
incremental
impacts
(
Step
4)
and
the
number
of
registration
actions
by
each
firm
to
get
the
distribution
of
incremental
impacts
per
firm
(
Step
5).
The
incremental
costs
per
small
firm
are
divided
by
the
entities=
sales
revenue
to
get
the
distribution
of
incremental
impacts
per
small
firm
as
a
percent
of
sales
revenue
(
Step
6;
see
Section
8).
19
Chart
5­
1:
Methods
Flowchart
for
Analyzing
the
Economic
Impacts
of
the
40
CFR
Part
158
Subparts
L&
M
Proposed
Rule
Unit
Test
Cost
STEP
1:

Data
Requirements
Baseline
Data
Requirements
Proposed
Rule
Test
Cost
Baseline
Test
Cost
Proposed
Rule
Incremental
Cost
&
Impact
of
Waivers
Annual
#
of
Registrations
Industry­
wide
Incremental
Cost
Annual
#
of
Registrations
by
Firm
Industry
Profile
and
Sales
Revenue
by
a
Small
Firm
Distribution
of
Incremental
Cost
per
Firm
Distribution
of
Incremental
Costs
as
a
%
of
Sales/
Firm
STEP
2:

STEP
3:

STEP
4:

STEP
5:

STEP
6:
20
5.1
Unit
Test
Costs
(
Step
1)

In
order
to
provide
the
data
required
for
a
registration,
registrants
must
submit
or
cite
test
results
or
other
information
to
satisfy
the
data
requirements.
The
test
costs
are
the
costs
of
complying
with
the
specific
data
requirements,
which
depend
on
the
type
of
product
and
use
pattern.
The
baseline
EPA
contacted
a
number
of
laboratories
to
obtain
cost
data
for
different
test
requirements
conducted
by
testing
labs.
Laboratories
were
asked
to
identify
the
method,
range,
analytical,
and
fixed
cost
for
each
guideline
based
on
a
set
of
predetermined
protocols.
If
for
any
test
the
component
costs
were
not
available,
the
laboratories
were
asked
to
provide
a
total
cost.
Understanding
that
the
lab
costs
could
vary
considerably
based
on
the
study
protocol
chosen
by
the
lab,
high
cost
and
low
cost
estimates
were
requested
for
each
study
protocol
in
order
to
bracket
the
costs.
To
establish
the
protocols,
EPA
initially
identified
the
various
study
design
options
for
each
study
based
on
the
Office
of
Pesticide
Prevention
and
Toxic
Substances
(
OPPTS)
guidelines.

The
Agency
collected
low
and
high
cost
estimates
from
actual
testing
labs
for
each
guideline.
For
each
data
requirement,
the
Agency
averaged
the
low
and
high
cost
estimates
provided
by
the
various
laboratories
(
see
Appendix
A:
Test
Cost
Data
Used
to
Calculate
Guideline
Costs
for
40
CFR
Part
158
Subparts
L&
M).
The
estimated
average
costs
of
complying
with
individual
OPPTS
guidelines
ranged
from
$
233
(
880.1100,
Product
identity)
to
$
1,730,000
(
870.4200,
Carcinogenicity
 
two
species).

5.2
Data
Requirements
Per
Registration
Action
(
Step
2)

A
registration
action
is
a
decision
on
an
application
from
a
registrant
to
register
a
product
containing
a
new
active
ingredient
or
another
type
of
new
product,
to
add
new
uses
to
existing
products,
or
to
amend
existing
products.
The
data
required
for
a
registration
action
depends
on
several
factors
as
described
in
Section
2.
In
this
section,
data
requirements
are
summarized
in
terms
of
the
following
variables:
data
category
(
data
discipline),
use
pattern,
and
type
of
registration
action.

Data
Category
The
data
requirements
(
described
previously
under
Sections
2.4
and
2.5)
are
organized
into
the
following
seven
data
categories
or
disciplines:
toxicology,
human
exposure,
residue
chemistry,
product
chemistry,
ecological
effects,
environmental
fate,
and
non­
target
organisms.

Use
Pattern
Within
each
of
the
seven
data
requirement
categories
listed
above,
a
number
of
individual
tests
may
be
necessary.
One
of
the
factors
that
define
whether
a
particular
test
will
be
required
for
a
product
is
how
the
product
will
be
used,
which
is
known
as
the
pesticide=
s
use
pattern.
With
respect
to
biochemical
pesticide
data
requirements,
there
are
six
general
use
groups
identified
for
non­
target
organisms,
fate,
and
expression.
The
proposed
non­
target
organism
data
table
for
21
biochemicals
requires
five
general
use
groups,
with
no
distinction
between
food
and
non­
food
uses.
With
respect
to
microbial
pesticides,
there
are
currently
nine
use
categories
for
non­
target
species.
The
Agency
is
proposing
to
decrease
the
number
of
use
categories
to
eight.

Type
of
Registration
Action
The
specific
data
required
depend
partly
on
the
type
of
registration
action.
The
following
types
of
registration
actions
are
affected
by
the
proposed
rule:
new
active
ingredient,
major
new
use,
and
substantive
amendment.
Registration
actions
are
tracked
in
an
EPA
database
called
PRATS
(
Pesticide
Registration
Action
Tracking
System).

There
are
three
ways
to
satisfy
data
requirements:
data
may
be
newly
developed
for
a
registration
action,
data
previously
submitted
for
an
existing
product
may
be
cited
for
a
new
registration
action,
or
specifically
requested
data
requirements
can
be
waived.
This
analysis
considers
only
the
costs
of
generating
and
submitting
new
data
and
the
cost
saving
impacts
of
waivers
(
which
is
discussed
in
greater
detail
in
Section
6).

5.3
Incremental
Costs
Per
Registration
Action
(
Step
3)

The
incremental
costs
are
the
differences
in
test
costs
between
the
baseline
test
costs,
i.
e.,
the
tests
described
in
current
40
CFR
part
158
data
requirements
for
biochemical
and
microbial
pesticides,
and
the
cost
of
tests
as
required
under
the
proposed
rule.
The
effect
of
waivers
is
associated
with
the
cost
savings
due
to
submission,
review,
and
approval
of
waivers
for
certain
tests
considered
rational
to
exclude
from
the
registration
action
data
requirements.

5.3.1
Estimation
of
Incremental
Costs
Changes
Included
in
Estimating
Incremental
Costs:

°
Newly
Imposed:
New
tests
and
increased
frequency
of
data
requirements
that
are
not
currently
being
imposed
are
a
subset
of
the
newly
codified
new
tests
and
expanded
use
pattern
data
requirements.
The
incremental
costs
of
these
tests
are
based
on
the
predicted
change
in
frequency
of
these
newly
imposed
data
requirements
for
new
registrations
in
the
future.
For
example,
exposure
data
for
insect
repellents
are
newly
imposed
data
requirements.
°
Newly
Codified
Tests:
Test
requirements
that
are
not
currently
included
in
40
CFR
Part
158
L&
M
are
not
in
the
baseline,
even
though
they
may
be
currently
required
in
practice.
Therefore,
the
incremental
costs
include
the
cost
of
all
tests
in
the
proposed
rule
that
are
not
now
codified
in
the
CFR.
°
Newly
Codified
Expanded
Use
Pattern:
In
some
cases,
the
proposed
rule
increases
the
frequency
of
data
required
in
the
tests
currently
in
40
CFR
Part
158
L&
M.
Examples
include:
(
1)
data
not
currently
required
will
be
required
in
the
proposed
rule
for
certain
use
patterns;
(
2)
data
currently
conditionally
required
would
be
routinely
required
by
the
proposed
rule
for
certain
use
site
categories;
and
(
3)
some
current
footnotes
specifying
when
data
are
required
have
been
changed
in
a
manner
that
22
expands
the
application
of
the
data
requirement.
For
microbial
pesticides,
the
proposed
changes
make
non­
target
organism
and
environmental
fate
data
conditionally
required
(
CR)
for
industrial
uses.

Incremental
Costs
Estimation
Procedure
EPA
is
continuing
its
current
system
of
identifying
the
applicability
of
data
requirements
in
the
40
CFR
part
158
subparts
L&
M
data
tables.
The
biochemical
pesticides
data
tables
are
found
in
sections
158.930
through
158.960
and
the
microbial
pesticides
data
tables
are
found
in
sections
158.1020
through
158.1050.
Because
of
the
variety
of
chemicals
and
use
patterns,
and
because
EPA
must
retain
flexibility
to
tailor
data
requirements
to
its
needs,
it
uses
only
qualitative
descriptors
in
the
tables.
These
are
used
for
convenience
to
make
the
table
format
feasible,
but
serve
only
as
a
general
indication
of
the
applicability
of
a
data
requirement.
In
all
cases,
the
test
notes
referred
to
in
the
table
must
be
consulted
to
determine
the
actual
applicability
of
the
data
requirement.

The
table
descriptors
(
NR
[
not
required],
R
[
required],
and
CR
[
conditionally
required])
in
the
proposed
rule
can
be
viewed
as
markers
along
a
spectrum
of
the
likelihood
that
the
data
requirement
applies.
The
use
of
"
R"
does
not
necessarily
indicate
that
a
study
is
always
required,
but
that
it
is
more
likely
to
be
required
than
not.
The
use
of
"
CR"
means
a
study
is
less
likely
to
be
required.
If
percentages
were
to
be
assigned,
"
R"
typically
represents
the
range
of
50­
100
percent
and
"
CR"
represents
up
to
50
percent.

The
unit
test
costs
of
new
tests
are
multiplied
by
the
percentage
of
the
time
each
test
is
likely
to
be
required
for
a
particular
registration
action.
The
Agency
determined
the
percentages
by
using
the
OPPIN
database,
which
contains
the
listing
of
all
registration
test
data
submitted
to
the
Agency.
The
percent
of
the
time
each
test
is
required
for
the
proposed
rule
(
the
"
proposed"
probabilities)
is
based
on
the
percent
of
registrations
for
which
it
was
required
for
biopesticides
registered
between
1997
and
2004
(
see
US
EPA.
2005.
"
Analysis
of
Data
Requirements
for
Biochemical
and
Microbial
Pesticides
from
1997­
2004.").
These
registrations
capture
the
data
requirements
currently
imposed
by
the
Agency
on
a
case­
by­
case
basis
that
will
be
codified
in
the
proposed
changes
to
40
CFR
158.
Additional
effects
of
the
proposed
rule
due
to
the
few
changes
to
data
requirements
that
have
not
been
imposed
between
1997
and
2004
were
estimated
based
on
EPA
experience
and
best
judgment.
EPA
scientists
used
their
expert
judgment
to
estimate
the
percent
of
time
the
tests
were
required
for
the
baseline,
or
the
percent
of
time
each
data
requirement
was
required
based
on
the
established
1984
final
rule
(
see
Appendix
B).
In
cases
where
the
frequency
of
a
test
requirement
would
change
under
the
proposed
rule,
the
incremental
cost
of
each
data
requirement
is
estimated
by
multiplying
the
change
in
frequency
(
percent
of
time
test
is
required)
by
the
unit
test
cost
using
low,
average,
and
high
test
cost
estimates.

5.4
Industry­
Wide
Impacts
(
Step
4)

In
order
to
calculate
the
impact
on
the
whole
industry,
the
incremental
costs
for
each
type
of
biochemical
and
microbial
registration
action
(
Step
3)
are
multiplied
by
the
average
number
of
registration
actions
per
year.
EPA
identified
a
total
of
51
individual
firms
as
being
involved
in
one
or
more
of
the
69
total
biochemical
and
microbial
pesticide
registration
actions
(
48
and
21
registration
actions,
respectively)
that
occurred
between
1997
and
2004.
Specifically,
34
firms
23
registered
biochemical
pesticides
and
19
firms
registered
microbial
pesticides.
As
a
result,
EPA
estimated
an
average
of
6.0
biochemical
and
2.6
microbial
pesticide
registration
actions
will
occur
annually.

Appendix
B
includes
the
baseline
percentage
of
time
and
incremental
percentage
of
time
based
on
the
proposed
rule
that
each
data
requirement
specified
by
OPPTS
guideline
number
and
description
is
required,
conditionally
required,
or
not
required.
These
incremental
percentages
are
multiplied
by
the
unit
test
costs
and
summed
for
all
registration
actions
to
determine
the
cost
per
action.

EPA
calculated
the
number
of
waivers
granted
between
1997
and
2004
for
each
biochemical
and
microbial
registration
on
a
case­
by­
case
basis.
These
data
were
compiled
to
estimate
the
percentage
of
time
each
individual
test
was
subject
to
a
waiver
as
part
of
the
data
requirements
for
the
respective
registration
action.
Appendix
B
also
includes
the
historical
and
modified
waiver
percentages
per
OPPTS
guideline.

Based
on
the
average
test
cost
estimates,
the
total
annual
industry­
wide
incremental
impact
based
on
an
average
of
6.0
biochemical
pesticide
registration
actions
and
2.6
microbial
pesticide
registration
actions
per
year
is
estimated
to
result
in
a
total
cost
savings
of
about
$
3.04
million
under
the
proposed
rule
and
about
$
3.20
million
under
the
low­
cost
alternative.
The
highcost
alternative
is
estimated
to
result
in
a
total
cost
increase
of
$
3.44
million
annually.
These
estimates
are
based
on
an
examination
of
historical
registration
actions
and
data
waivers
from
1997
to
2004.
Table
5­
1
summarizes
the
total
annual
costs
for
the
proposed
rule
and
the
two
alternatives.
24
Table
5­
1:
Total
Annual
Cost
of
the
Proposed
Rule
and
Alternative
Data
Requirements
to
Biochemical
and
Microbial
Pesticide
Industry
Total
Annual
Cost
Data
Requirement
Category
Low
Test
Costs
Average
Test
Costs
High
Test
Costs
Proposed
Rule
Product
Chemistry
­$
288,148
­$
221,334
­$
154,520
Non­
target
Organisms
and
Environmental
Fate
­$
1,261,380
­$
1,070,067
­$
878,754
Human
Health
Assessment/
Toxicology
­$
1,884,987
­$
1,578,954
­$
1,272,922
Residue
­$
235,219
­$
182,927
­$
130,635
Waivers1
$
15,250
$
15,250
$
15,250
Total
­$
3,654,483
­$
3,038,031
­$
2,421,579
Biochemical
Pesticides
­$
2,643,190
­$
2,240,305
­$
1,837,419
Microbial
Pesticides
­$
1,011,293
­$
797,726
­$
584,160
Low­
Cost
Alternative
Product
Chemistry
­$
288,148
­$
221,334
­$
154,520
Non­
target
Organisms
and
Environmental
Fate
­$
1,443,695
­$
1,229,777
­$
1,015,858
Human
Health
Assessment/
Toxicology
­$
1,884,987
­$
1,578,954
­$
1,272,922
Residue
­$
235,219
­$
182,927
­$
130,635
Waivers1
$
15,250
$
15,250
$
15,250
Total
­$
3,836,798
­$
3,197,741
­$
2,558,684
Biochemical
Pesticides
­$
2,741,443
­$
2,330,999
­$
1,920,555
Microbial
Pesticides
­$
1,095,355
­$
866,742
­$
638,129
High­
Cost
Alternative
Product
Chemistry
­$
288,148
­$
221,334
­$
154,520
Non­
target
Organisms
and
Environmental
Fate
$
16,818
$
176,281
$
335,745
Human
Health
Assessment/
Toxicology
$
3,296,087
$
3,649,265
$
4,002,443
Residue
­$
235,219
­$
182,927
­$
130,635
Waivers1
$
15,250
$
15,250
$
15,250
Total
$
2,804,789
$
3,436,536
$
4,068,284
Biochemical
Pesticides
$
2,881,689
$
3,368,891
$
3,856,094
Microbial
Pesticides
­$
76,900
$
67,645
$
212,190
Source:
OPPIN
2005,
Dun
&
Bradstreet
Market
Spectrum
Web
2005,
SBA
Size
Standards
2005
1
The
cost
of
applying
for
waivers
is
estimated
to
be
approximately
$
2,000
per
firm
per
registration
action,
regardless
of
the
number
of
tests
a
waiver
is
applied
for,
if
at
least
one
waiver
was
granted.

5.5
Average
Annual
Cost
per
Firm
(
Step
5)

5.5.1
Annual
Data
Requirement
Costs
According
to
the
PRATS
database,
51
firms
would
have
experienced
incremental
impacts
from
the
proposed
rule
during
the
8­
year
period,
1997
to
2004.
Each
firm
would
have
incurred
on
average
a
data
requirement
cost
savings
of
approximately
$
60,000
per
firm
per
year
if
the
proposed
rule
had
been
in
effect.
Under
the
low­
cost
alternative,
the
average
data
requirement
cost
savings
would
have
been
approximately
$
63,000
per
firm
per
year.
The
high­
cost
alternative
would
have
cost
the
average
firm
an
additional
$
67,000
per
year.
Table
5­
2
details
the
annual
costs
per
firm
for
the
proposed
rule
and
the
two
alternatives.
25
Table
5­
2:
Annual
Cost
per
Firm
of
the
Proposed
Rule
and
Alternative
Data
Requirements
to
Biochemical
and
Microbial
Pesticide
Industry
Annual
Cost
per
Firm
Company
Size1
Number
of
Companies
Low
Test
Costs
Average
Test
Costs
High
Test
Costs
Propose
Rule
Small
23
­$
68,697
­$
57,285
­$
45,872
Large
17
­$
84,012
­$
70,068
­$
56,125
All2
51
­$
71,657
­$
59,569
­$
47,482
Low­
Cost
Alternative
Small
23
­$
71,826
­$
60,076
­$
48,326
Large
17
­$
88,077
­$
73,644
­$
59,211
All2
51
­$
75,231
­$
62,701
­$
50,170
High­
Cost
Alternative
Small
23
$
72,081
$
85,376
$
98,671
Large
17
$
52,606
$
65,939
$
79,272
All2
51
$
54,996
$
67,383
$
79,770
Source:
OPPIN
2005,
Dun
&
Bradstreet
Market
Spectrum
Web
2005,
SBA
Size
Standards
2005
1
Size
definition
varies
by
company
according
to
NAICS
code.
2
The
total
number
of
"
all
companies"
is
not
equal
to
the
sum
of
the
small
and
large
parent
company
categories
because
it
includes
eleven
companies
missing
sufficient
financial
information
available
from
the
Dun
&
Bradstreet
(
D&
B)
database
to
determine
the
appropriate
SBA
size
classification.

5.5.2
Reporting
and
Recordkeeping
Burden
and
Costs
In
addition
to
the
costs
of
the
data
requirements,
there
is
reporting
and
record
keeping
burden
associated
with
compliance
with
the
proposed
rule.
The
Paperwork
Reduction
Act
requires
federal
agencies
to
account
for
these
types
of
burden
activities.
For
this
analysis,
reporting
and
recordkeeping
burden
and
costs
were
derived
using
the
supporting
statement
for
the
current
Section
3
Data
Acquisition
for
Registration
Information
Collection
Request
(
ICR)
(
OMB
Control
No.
2070­
0122).
All
respondents
share
the
cost.
This
cost
is
an
upper
bound
estimate.
The
Agency
has
already
captured
the
burden
for
most
of
the
data
requirements
it
currently
imposes
through
ICRs
for
the
Data
Call­
Ins
(
DCIs).
Under
Section
3
registration,
registrants
or
applicants
submit
information
in
three
categories.
In
the
40
CFR
part
158
subparts
L&
M
proposed
rule
only
"
Type
A"
are
affected.

"
Type
A"
activities
involve
a
registrant
or
applicant
assembling
and
submitting
an
application
for
registration
of
a
new
active
ingredient
or
a
major
new
use
for
a
currently
registered
active
ingredient.
Typically
for
new
active
ingredients,
an
application
must
be
submitted
for
at
least
two
new
products 
the
manufacturing
use
product
(
either
imported
or
made
in
the
United
States)
that
may
be
formulated
into
an
end
use
product,
and
at
least
one
end­
use
product
(
that
bears
the
directions
for
the
intended
end
use).
The
calculation
for
the
reporting
and
recordkeeping
burden
hours
and
costs
is
shown
in
Table
5­
3
below.
26
Table
5­
3:
Annual
Biochemical
or
Microbial
Registrant
Reporting
and
Recordkeeping
Burden
Due
to
Proposed
Changes
to
40
CFR
Part
158
Subparts
L&
M:
New
Active
Ingredients
and
New
Uses1
Burden
Hours
(
per
year)
Total
Burden
Activities
Mgmt.
$
134/
hr.
Tech.
$
91/
hr
Clerical
$
41/
hr
Hours
Costs
$

Read
Instructions
18
0
0
18
$
2,412
Plan
Activities
4
0
0
4
$
536
Gather/
Create
Information
0
120
0
120
$
10.920
Compile
and
Review
4
8
0
12
$
1,254
Complete
Paperwork
0
0
30
30
$
1,230
Store/
Maintain
Data
0
0
10
10
$
410
TOTAL
26
128
44
210.5
$
16,762
Source:
Application
for
New
or
Amended
Pesticide
Registration
(
Section
3),
OMB
Control
No.
2070­
060,
pending
EPA
ICR
No.
0277.14
1
The
estimated
Paperwork
Reduction
Act
(
PRA)
reporting
and
recordkeeping
burden
per
registrant.

5.5.3
Summary
of
Annual
Costs
per
Firm
The
direct
costs
savings
of
the
proposed
rule
are
to
the
biochemical
and
microbial
pesticide
registrant
community.
Table
5­
4
summarizes
the
total
average
costs
of
the
proposed
rule
and
the
two
alternatives
per
firm
per
year.
EPA
estimated
the
likely
expenditures
to
be
incurred
by
regulated
entities,
which
may
be
an
acceptable
first­
order
approximation
of
the
true
cost
given
the
magnitude
of
the
rule.
The
proposed
rule
and
low­
cost
alternative
are
estimated
to
result
in
an
average
annual
cost
savings
of
approximately
$
42,000
and
$
50,000
per
firm,
respectively.
The
high­
cost
alternative
is
estimated
to
result
in
an
average
annual
cost
increase
of
approximately
$
84,000
per
firm.
The
cost
of
compliance
estimates
for
the
proposed
rule
and
the
two
alternatives
are
based
on
an
analysis
of
registration
costs
and
do
not
include
reregistration
because,
by
the
time
this
rule
is
promulgated
and
effective,
it
is
anticipated
that
virtually
all
requirements
for
reregistration
will
have
been
met.
27
Table
5­
4:
Total
Average
Annual
Cost
per
Firm
Due
to
Proposed
Changes
to
40
CFR
Part
158
Subparts
L&
M
Annual
Cost
Proposed
Rule
Low­
Cost
Alternative
High­
Cost
Alternative
Data
Requirements1,2
­$
59,569
­$
62,701
$
67,383
Recordkeeping
and
Reporting
Requirements3
$
16,762
$
16,762
$
16,762
Total
­$
42,087
­$
49,539
$
84,145
1
Incremental
data
requirement
costs
of
the
proposed
rule
per
firm
were
based
on
review
of
1997
to
2004
registration
activity,
which
considered
costs
associated
with
the
type
and
frequency
of
the
various
biochemical
and
microbial
pesticide
registration
actions
that
occurred;
the
related
applicability
of
the
various
data
requirements
for
those
actions;
the
type
and
regularity
of
waivers
granted
by
EPA
for
certain
data
requirements;
and
information
about
the
applicants
involved
in
those
actions.
Where
applicable,
these
cost
impacts
were
used
to
predict
future
registration
activity.
Additional
cost
impacts
of
the
proposed
rule
due
to
newly
proposed,
revised,
or
modified
40
CFR
part
158
subparts
L&
M
data
requirements
were
estimated
based
recent
test
cost
data
collected
and
EPA
experience
and
best
judgment.
2
This
cost
estimate
includes
approximately
$
2,000
for
data
waivers
per
firm
per
registration
action,
regardless
of
the
number
of
tests
a
waiver
is
applied
for.
3
The
estimated
Paperwork
Reduction
Act
(
PRA)
reporting
and
recordkeeping
burden
per
registrant
per
year
derived
from
the
supporting
statement
for
the
pending
Application
for
New
and
Amended
Pesticide
Registration
(
Section
3)
(
OMB
Control
No.
2070­
0060,
pending
EPA
ICR
No.
0277.14).

6
ESTIMATED
IMPACTS
OF
DATA
WAIVERS
40
CFR
part
158
provides
flexibility
for
the
Agency
to
waive
data
requirements
it
determines
to
be
inapplicable
to
a
specific
pesticide
product
(
§
158.45).
A
product's
physical,
chemical,
or
biological
properties,
or
its
particular
use
patterns,
may
make
it
impossible
to
generate
the
required
data.
The
Agency
may
determine
that
certain
required
data
would
not
be
useful
in
evaluating
the
risks
and
benefits
of
a
product.
The
Agency
waives
data
requirements
on
a
case­
by­
case
basis
in
response
to
specific
written
requests
by
applicants.

The
continued
practice
of
submission
and
granting
of
data
waivers
plays
an
important
role
in
the
economic
impact
of
the
proposed
changes.
Costs
avoided
due
to
data
waivers
offset
the
cost
impacts
due
to
the
proposed
changes
in
data
requirements
compared
to
the
baseline.
For
some
firms,
or
for
some
very
safe
biochemical
or
microbial
pesticides,
the
costs
avoided
could
be
much
greater.
This
may
be
important
from
an
environmental
standpoint,
because
the
money
and
time
saved
may
help
potentially
safer
pesticides
become
available
sooner,
and
may
help
them
compete
in
the
marketplace
with
pesticides
that
are
much
less
safe.

This
analysis
uses
two
approaches
to
estimate
the
costs
savings
to
industry
of
waiving
particular
tests.
Each
data
waiver
analysis
considers
the
impacts
based
on
low,
average,
and
high
test
cost
scenarios.
Through
pre­
proposal
stage
consultations
with
stakeholders,
EPA
estimates
the
cost
to
a
pesticide
registrant
of
applying
for
a
waiver
is
approximately
$
2,000
per
registration,
regardless
of
the
number
of
tests
a
waiver
is
applied
for.
The
availability
of
data
waivers
results
in
a
total
annual
cost
savings
from
having
particular
required
or
conditionally
required
tests
waived,
compared
to
if
there
were
no
provision
in
the
rule
for
waiving
data
requirements.

In
the
first
approach,
the
data
submitted
to
support
registration
from
1997
to
2004
were
reviewed
and
the
percentages
of
waivers
granted
for
each
test
in
each
subcategory
were
28
calculated
(
hereafter
referred
to
as
the
"
historical
waiver
approach").
The
percentages
by
subcategory
and
test
are
listed
in
Appendix
B.
The
results
of
this
approach
show
the
average
cost
per
year
of
tests
that
were
avoided
because
waivers
were
granted
from
1997
to
2004.

The
proposed
changes
to
part
158
may
alter
the
frequency
that
some
data
requirements
are
waived.
Changing
data
requirements
from
"
not
required"
to
"
conditionally
required"
or
"
required,"
or
from
"
conditionally
required"
to
"
required"
for
certain
pesticide
types
or
use
patterns
may
increase
the
amount
of
waivers
that
are
granted.
On
the
other
hand,
changing
a
data
requirement
from
"
required"
or
"
conditionally
required"
to
"
not
required,"
or
"
required"
to
"
conditionally
required"
may
reduce
the
number
of
waivers
that
are
granted
because
a
registrant
will
not
apply
for
a
waiver
for
a
data
requirement
that
is
not
required
by
the
rule.

The
second
"
modified"
approach
to
estimating
the
cost
savings
from
waivers
uses
the
historical
record
of
waivers
as
the
basis
but
changes
assumptions
where
the
proposed
rule
makes
waivers
in
certain
categories
less
likely
(
hereafter
referred
to
as
the
"
modified
waiver
approach").
The
percentages
by
subcategory
and
test
are
listed
in
Appendix
B.
Notes
on
the
reasons
for
the
estimates
are
included
by
biopesticide
category
and
test
category
below.
The
results
of
this
approach
show
the
average
cost
per
year
of
tests
that
were
avoided
because
waivers
were
granted
under
our
assumptions
about
how
the
proposed
changes
to
part
158
will
affect
the
frequency
waivers
are
granted.
As
with
the
rest
of
this
economic
analysis,
this
"
modified"
approach
assumes
that
registration
of
the
various
types
of
biopesticides
will
continue
at
the
same
rate
as
from
1997
to
2004.

6.1
Data
Waiver
Analysis:
Biochemical
Pesticides
Growth
Regulators
°
Product
Chemistry
Data
Requirements:
For
growth
regulators
the
product
chemistry
guidelines
are
required
for
both
food
and
non­
food
uses.
Historically,
during
the
period
1997
through
2004,
only
two
waivers
were
granted
for
product
chemistry
data
requirements
for
growth
regulators 
one
for
a
stability
test
and
the
second
for
a
flammability
test.
The
proposed
rule
addresses
the
reasons
for
these
waivers
by
changing
the
test
substance
in
the
former
and
by
requiring
a
test
only
when
the
EP
is
combustible
in
the
latter.
As
a
result,
for
the
modified
waiver
analysis
these
data
requirements
were
reclassified
to
"
not
required,"
and
it
was
assumed
that
the
chance
of
granting
a
waiver
in
this
category
is
zero
percent.
°
Residue
Data
Requirements:
The
chemical
identity
and
the
directions
for
use
procedures
are
universally
required
for
food
and
nonfood
uses.
The
other
tests
should
be
assumed
to
be
waived
for
nonfood
uses
based
on
historical
data
from
the
period
1997
to
2004,
when
only
one
pesticide
required
residue
testing.
Food
uses
generally
require
waivers.
°
Human
Health
Assessment
Data
Requirements:
The
acute
toxicity
testing
requirements
were
rarely
waived
between
1997
and
2004,
while
the
more
advanced
data
were
frequently
waived.
This
analysis
uses
the
same
waiver
probabilities
in
the
historical
and
modified
approaches.
29
°
Non­
target
Organisms
and
Environmental
Fate
Data
Requirements:
This
analysis
assumes
that
non­
target
organisms
and
environmental
fate
data
requirements
will
continue
to
be
waived
at
historical
levels;
therefore,
the
historical
and
modified
waiver
percentages
were
the
same.

Straight
Chain
Lepidopteran
Pheromones
(
SCLP)

°
Product
Chemistry
Data
Requirements:
The
product
chemistry
data
is
required.
This
analysis
assumes
the
chance
of
granting
a
waiver
in
this
category
is
zero.
This
continues
the
pattern
found
in
the
historical
data.
°
Residue
Data
Requirements:
The
chemical
identity
and
the
directions
for
use
are
universally
required.
This
analysis
assumes
the
other
tests
will
be
waived
at
the
same
rate
they
were
from
the
period
1997
to
2004.
These
tests
were
waived
for
100
percent
of
registrations
due
to
the
likelihood
that
there
is
no
residue
in
or
on
a
food
commodity.
The
small
likelihood
that
residue
is
present
results
from
SCLP
use
patterns
and
the
biochemical
pesticides'
volatility.
°
Human
Health
Assessment
Data
Requirements:
The
proposed
rule
sets
an
application
threshold
of
150
grams
of
active
ingredient
per
acre
per
year,
below
which
these
tests
are
not
required.
During
the
1997
to
2004
period,
these
tests
were
universally
waived.
This
analysis
assumes
that
new
registrations
will
be
for
application
rates
below
the
150
g/
a.
i./
year
threshold;
otherwise,
these
tests
would
be
required
to
support
registration.
Based
on
this
assumed
application
rate,
we
assume
that
these
tests
will
be
considered
"
not
required"
under
the
proposed
rule,
and
no
waivers
will
need
to
be
granted.
°
Non­
target
Organisms
and
Environmental
Fate
Data
Requirements:
Similar
to
the
human
health
assessment
data
requirements,
we
assume
that
new
registrations
will
be
below
the
rate
that
triggers
the
requirement
of
these
tests
and
no
waivers
will
be
granted.

Other
Pheromones
°
Product
Chemistry
Data
Requirements:
These
data
are
required.
During
the
period
1997
to
2004,
three
waivers
for
"
other
pheromones"
were
granted.
This
analysis
assumes
that
the
historical
frequency
of
waivers
granted
for
specific
guidelines
will
be
the
same
in
the
future;
therefore,
the
historical
and
modified
waiver
percentages
are
the
same.
°
Residue
Data
Requirements:
The
chemical
identity
and
the
directions
for
use
are
universally
required.
The
other
residue
tests
were
not
required
historically
and
no
waivers
were
given.
This
analysis
assumes
no
waivers
will
be
granted
for
this
category.
°
Human
Health
Assessment
Data
Requirements:
This
analysis
assumes
that
Tier
I
human
health
assessment
guidelines
will
continue
to
be
waived
at
historic
rates.
Insufficient
data
are
available
on
the
application
rate
of
the
three
pheromones
registered
during
the
1997
to
2004
period.
All
cases
were
arthropod
pheromones
and
all
tests
were
either
waived
or
not
required.
This
analysis
assumes
these
waivers
were
granted
for
application
rates
below
150
grams
active
ingredient/
acre/
year.
°
Non­
target
Organisms
and
Environmental
Fate
Data
Requirements:
Under
the
proposed
rule,
non­
target
organism
testing
is
not
required
for
arthropod
pheromones
30
applied
at
a
rate
less
than
150
grams
of
active
ingredient
per
acre
per
year
for
terrestrial
uses.
Without
knowing
the
application
rate
of
the
three
pheromones
registered
during
the
1997
to
2004
period,
this
analysis
assumes
that
under
the
proposed
rule
there
would
be
no
need
for
waivers
to
be
granted
because
these
tests
will
be
"
not
required"
for
usage
rates
below
the
150
grams
active
ingredient/
acre/
year
threshold.

Other
Biochemicals
°
Product
Chemistry
Data
Requirements:
These
data
are
required.
During
the
period
1997
to
2004,
26
biochemical
pesticides
were
registered.
This
analysis
assumes
that
the
historical
frequency
of
waivers
granted
for
specific
guidelines
will
be
the
same
in
the
future.
°
Residue
Data
Requirements:
The
chemical
identity
and
the
directions
for
use
are
universally
required
and
will
not
be
waived.
When
the
other
tests
are
required
they
have,
historically,
been
consistently
waived.
Therefore,
this
analysis
assumes
that
all
other
tests
will
be
waived
in
the
future.
°
Human
Health
Assessment
Data
Requirements:
These
data
are
required.
During
the
period
1997
to
2004,
26
pesticides
were
registered.
This
analysis
assumes
that
the
historical
frequency
of
waivers
granted
for
specific
guidelines
will
be
the
same
in
the
future.
°
Non­
target
Organisms
and
Environmental
Fate
Data
Requirements:
These
data
are
required
but
were
waived
frequently
in
the
period
1997
to
2004.
This
analysis
assumes
that
the
historical
frequency
of
waivers
granted
for
specific
guidelines
will
continue
in
the
future.

Repellents
°
Product
Chemistry
Data
Requirements:
These
data
are
required.
Based
on
the
historical
data
for
1997
to
2004
for
eight
repellents
with
non­
food
uses,
several
waivers
were
granted
for
specific
guidelines.
This
analysis
assumes
that
the
rate
of
waivers
granted
in
the
future
will
be
the
same
as
for
these
eight
repellents.
°
Residue
Data
Requirements:
The
chemical
identity
and
the
directions
for
use
are
universally
required
and
will
not
be
waived.
The
other
tests
are
not
required
in
the
new
rule;
thus
no
waivers
will
be
granted
for
these
tests.
°
Human
Health
Assessment
Data
Requirements:
These
data
are
required
for
repellents,
particularly
insect
repellents.
The
data
available
do
not
support
differentiating
waiver
rates
for
insect
repellents
and
other
repellents,
so
this
analysis
assumes
that
the
future
waiver
rate
will
continue
at
the
historical
rate.
°
Non­
target
Organisms
and
Environmental
Fate
Data
Requirements:
Basic
acute
toxicity
testing
(
e.
g.,
oral
and
dietary
testing
in
fish
and
birds,
invertebrate
testing)
is
required
to
support
repellents
where
there
is
potential
exposure
to
these
organisms.
Between
1997
and
2004,
eight
repellents
were
registered.
Two
required
avian
oral
toxicity
testing
and
one
additionally
required
avian
dietary
toxicity,
freshwater
fish
toxicity,
and
acute
toxicity
freshwater
invertebrates
testing.
This
analysis
uses
the
historic
waiver
rates
to
predict
the
future
waiver
rates.
31
6.2
Data
Waiver
Analysis:
Microbial
Pesticides
Viruses
°
Product
Chemistry
Data
Requirements:
These
data
are
required.
Based
on
the
historical
data
for
1997
to
2004,
only
one
virus
was
registered
and
no
waivers
were
granted.
This
analysis
assumes
that
the
modified
probability
of
waivers
is
zero
for
viruses.
°
Residue
Data
Requirements:
Residue
chemistry
data
are
conditionally
required
for
mammalian
toxins
with
a
use
such
that
it
may
be
present
on
food
or
feed
crops.
Because
the
historical
record
does
not
include
any
information
on
these
viruses,
this
analysis
assumes
that
there
will
be
no
waivers
when
the
tests
are
required.
°
Toxicology
Data
Requirements:
Toxicology
data
are
required
or
conditionally
required
for
viruses.
All
of
the
guidelines
may
be
waived.
Only
one
virus
was
registered
in
the
1997
to
2004
period,
but
this
analysis
assumes
that
the
modified
probability
of
waivers
is
the
same
as
the
waiver
that
were
granted
for
that
virus
absent
better
information.
°
Non­
target
Organisms
and
Environmental
Fate
Data
Requirements:
Non­
target
and
environmental
fate
testing
is
required
for
viruses.
For
the
single
virus
registered
between
1997
and
2004,
no
tests
were
required,
and
thus
none
were
waived.
This
analysis
assumes
that
no
tests
are
waived
under
the
modified
approach.

Fungi
°
Product
Chemistry
Data
Requirements:
For
fungi,
the
product
chemistry
data
are
required.
In
the
historical
data
for
1997
to
2004
for
eleven
fungi
(
4
food
use
and
9
non­
food
uses),
one
waiver
was
granted
for
stability
and
one
for
miscibility.
This
analysis
assumes
that
the
probability
of
waivers
in
the
future
is
the
same
as
for
these
11
fungi.
°
Residue
Data
Requirements:
The
residue
chemistry
is
conditionally
required
in
the
proposed
rule
for
mammalian
toxins
with
a
use
such
that
it
may
be
present
on
food
or
feed
crops.
Historically,
the
residue
requirements
were
waived
for
fungi;
however,
with
these
data
requirements
being
conditionally
required,
we
assume
that
they
will
be
submitted
when
the
condition
is
met,
and
otherwise
not
required.
Therefore
we
assume
that
no
waivers
will
be
granted.
°
Toxicology
Data
Requirements:
These
tests
are
required
or
conditionally
required.
Historically
many
of
the
required
or
conditionally
required
tests
have
been
waived.
This
analysis
assumes
that
the
probability
of
waivers
in
the
future
is
the
same
as
for
the
11
fungi.
°
Non­
target
Organisms
and
Environmental
Fate
Data
Requirements:
These
data
are
required
or
are
conditionally
required.
Historically
many
of
the
required
or
conditionally
required
tests
have
been
waived;
therefore,
this
analysis
assumes
that
the
probability
of
waivers
in
the
future
is
the
same
as
for
the
eleven
fungi.

Bacteria
32
°
Product
Chemistry
Data
Requirements:
These
data
are
required.
In
the
historical
data
for
1997­
2004
for
nine
bacteria,
waivers
were
occasionally
granted
for
specific
tests.
This
analysis
assumes
that
the
probability
of
waivers
in
the
future
will
be
the
same
as
for
the
nine
bacteria.
°
Residue
Data
Requirements:
These
tests
are
conditionally
required
in
the
proposed
rule
for
mammalian
toxins
with
a
use
such
that
it
may
be
present
on
food
or
feed
crops.
Historically,
the
residue
requirements
were
waived
for
bacteria;
however,
with
these
data
requirements
being
conditionally
required,
this
analysis
assumes
that
they
will
be
submitted
when
the
condition
is
met,
and
otherwise
not
required.
Therefore
no
waivers
are
assumed.
°
Toxicology
Data
Requirements:
These
data
are
required
or
conditionally
required.
Historically,
many
of
the
required
or
conditionally
required
tests
have
been
waived;
therefore,
we
assume
that
probability
of
waivers
in
the
future
is
the
same
as
for
the
nine
bacteria
registered
between
1997
and
2004.
°
Non­
target
Organisms
and
Environmental
Fate
Data
Requirements:
These
data
are
required.
Historically,
many
of
the
required
or
conditionally
required
tests
have
been
waived
for
both
food
and
non­
food
uses.
This
analysis
assumes
that
the
future
waiver
rate
will
be
the
same
as
for
these
eleven
fungi.

Protozoa
°
Only
one
protozoan­
based
microbial
pesticide
was
registered
from
1997
to
2004,
therefore
this
class
of
microbial
pesticide
was
omitted
from
data
waiver
analysis.

Tables
6­
1
and
6­
2
summarize
the
historical
and
modified
annualized
impact
of
biochemical
and
microbial
data
requirement
waivers.
Approximately
90
percent
of
the
total
cost
savings
associated
with
the
changes
in
the
proposed
rule
are
attributable
to
data
waivers.

Table
6­
1:
Impacts
of
Historical
Waiver
Analysis
on
Biochemical
and
Microbial
Pesticide
Registrations
Total
Annual
Cost
Savings
Annual
Costs
Avoided
per
Company
Company
Size1
Number
of
Companies
Low
Test
Costs
Mean
Test
Costs
High
Test
Costs
Low
Test
Costs
Mean
Test
Costs
High
Test
Costs
Small
23
$
13,800,000
$
16,180,000
$
18,560,000
$
600,000
$
700,000
$
810,000
Large
17
$
8,080,000
$
9,460,000
$
10,840,000
$
475,000
$
560,000
$
640,000
All2
51
$
25,260,000
$
29,600,000
$
33,940,000
$
500,000
$
580,000
$
670,000
Source:
OPPIN
2005,
Dun
&
Bradstreet
Market
Spectrum
Web
2005,
SBA
Size
Standards
2005
1
Size
definition
varies
by
company
according
to
NAICS
code.
2
The
total
number
of
"
all
companies"
is
not
equal
to
the
sum
of
the
small
and
large
parent
company
categories
because
it
includes
eleven
companies
missing
sufficient
financial
information
available
from
the
Dun
&
Bradstreet
(
D&
B)
database
to
determine
the
appropriate
SBA
size
classification.
33
Table
6­
2:
Impact
of
Modified
Waiver
Analysis
on
Biochemical
and
Microbial
Pesticide
Registrations
Total
Annual
Cost
Savings
Annual
Costs
Avoided
per
Company
Company
Size1
Number
of
Companies
Low
Test
Costs
Mean
Test
Costs
High
Test
Costs
Low
Test
Costs
Mean
Test
Costs
High
Test
Costs
Small
23
$
9,920,000
$
11,540,000
$
13,170,000
$
430,000
$
500,000
$
570,000
Large
17
$
7,590,000
$
8,860,000
$
10,130,000
$
450,000
$
520,000
$
600,000
All2
51
$
20,540,000
$
23,960,000
$
27,370,000
$
400,000
$
470,000
$
540,000
Source:
OPPIN
2005,
Dun
&
Bradstreet
Market
Spectrum
Web
2005,
SBA
Size
Standards
2005
1
Size
definition
varies
by
company
according
to
NAICS
code.
2
The
total
number
of
"
all
companies"
is
not
equal
to
the
sum
of
the
small
and
large
parent
company
categories
because
it
includes
eleven
companies
missing
sufficient
financial
information
available
from
the
Dun
&
Bradstreet
(
D&
B)
database
to
determine
the
appropriate
SBA
size
classification.

Under
the
proposed
changes
to
40
CFR
part
158
subparts
L&
M,
the
Agency
minimizes
data
requirements
for
evaluating
the
risks
of
a
particular
biochemical
or
microbial
pesticide
in
two
ways.
First,
the
proposed
rule
specifies
different
data
requirements
for
different
types
of
biochemical
and
microbial
pesticides,
depending
on
the
characteristics
and
use
pattern
of
each
type.
Second,
the
proposed
rule
allows
registrants
to
request
waivers
for
data
requirements
that
either
are
not
possible
to
obtain
or
are
not
needed
due
to
the
use
pattern
or
specific
characteristics
of
the
particular
product.
Tables
6­
3
and
6­
4
show
the
average
costs
avoided
for
tests
that
are
waived
for
each
of
the
different
types
of
biopesticides.
The
costs
savings
were
based
on
the
actual
registrations
from
1997
to
2004
and
test
cost
estimates
for
data
requirements
waived.

Table
6­
3:
Registration
Costs
Avoided
Due
to
Waivers 
Biochemical
Pesticides
Waiver
Frequency
Growth
Regulators
SCLPs
Other
Pheromones
Other
Biochemicals
Repellents
Historic
Rate
$
5,690,000
$
7,380,000
$
2,150,000
$
2,970,000
$
4,820,000
Modified
Approach
$
5,690,000
$
1,090,000
$
220,000
$
2,970,000
$
4,300,000
Note:
Based
on
average
test
cost
estimates.

Table
6­
4:
Registration
Costs
Avoided
Due
to
Waivers 
Microbial
Pesticides
Waiver
Frequency
Bacteria
Fungi
Virus
Historic
Rates
$
3,130,000
$
1,400,000
$
70,000
Modified
Approach
$
2,840,000
$
1,240,000
$
70,000
Note:
Based
on
average
test
cost
estimates.
34
Since
the
tests
required
by
the
rule
take
into
account
the
risk
of
the
specific
type
of
chemical
and
the
data
needed
to
evaluate
those
risks,
less
data
are
required
for
relatively
less
risky
types
of
biopesticides,
such
as
SCLPs
and
other
pheromones.
The
relatively
significant
difference
in
test
costs
avoided
due
to
waivers
for
SCLPs
and
other
pheromones
between
the
modified
approach
and
the
historic
rate
of
waivers
can
in
large
part
be
attributed
to
certain
data
requirements
changing
under
the
proposed
rule
from
"
required"
to
"
not
required."
This
will
result
in
less
burden
to
firms
and
the
Agency
to
submit
and
review
waiver
requests
for
data
requirements
not
needed
to
determine
the
risk
of
use
of
these
types
of
biopesticides.

7
OPTION
ANALYSIS
Costs
and
benefits
of
the
proposed
rule
and
two
alternative
approaches
are
summarized
and
compared
below.
The
Agency
arrived
at
the
proposed
rule
data
requirements
by
considering
the
pros
and
cons
of
each
option.
The
goal
was
to
ensure
that
EPA
receives
sufficient
data
to
inform
the
decision
for
any
biochemical
or
microbial
registration
action,
while
minimizing
the
impacts
on
pesticide
registrants.
These
impacts
include
the
direct
cost
of
generating
the
data,
cost
savings
associated
with
rational
use
and
EPA
approval
of
data
waivers,
as
well
as
less
tangible
costs
brought
about
by
uncertainty
in
registration
requirements.
Subsection
6.1
addresses
the
proposed
rule
costs
and
benefits
and
subsections
6.2
and
6.3
address
each
of
the
two
alternatives.

7.1
Proposed
Rule:
Decision
Criteria
Determination
and
Likelihood
of
Data
Requirement
Waivers
Costs
The
proposed
part
158
subparts
L&
M
data
requirement
changes
for
biochemical
and
microbial
pesticides
are
expected
to
result
in
an
estimated
total
annual
cost
savings
of
$
3.04
million.
The
cost
savings
is
due
primarily
to
the
submission
and
approval
of
waivers
for
certain
data
requirements,
eliminating
the
expense
of
generating
data
through
product
testing.
Waivers
have
historically
been
submitted,
reviewed,
and
approved
for
certain
tests
required
under
biochemical
and
microbial
pesticide
registration
actions,
including
tests
that
are
impossible
to
perform
on
a
particular
product
and
tests
that
are
not
needed
to
determine
the
risk
of
a
product.
Data
waivers
are
significantly
more
common
for
biochemical
and
microbial
pesticides
than
for
conventional
pesticides.
Certain
data
requirements
may
not
be
needed
because
biopesticides
are
inherently
relatively
nontoxic
and
generally
affect
only
the
target
pest
and
closely
related
organisms.

Benefits
The
proposed
rule
data
requirements
will
benefit
a
large
number
of
parties,
including
the
regulated
industry,
pesticide
users,
the
general
public,
other
federal,
state,
and
foreign
governments,
and
others
who
are
affected
by
or
interested
in
pesticide
use
or
regulation.
Additionally,
the
net
benefit
of
the
proposed
changes
is
expected
to
include
a
cost
savings
for
all
existing
and
future
biochemical
and
microbial
pesticide
registrants
versus
the
current
codified
requirements.

In
essence,
the
data
requirements
identify
the
questions
that
the
registrant
will
need
to
35
answer
regarding
the
safety
of
a
pesticide
product
before
the
Agency
can
register
it.
The
data
requirements
address
both
components
of
a
risk
assessment
(
i.
e.,
what
hazards
does
the
pesticide
present
and
at
what
level
of
exposure).
The
answer
to
one
question
may
inform
the
kind
of
information
needed
in
others.
Since
biochemical
and
microbial
pesticides
tend
to
pose
fewer
risks
than
conventional
pesticides,
EPA
generally
waives
certain
data
requirements
and
requires
much
less
data
overall
to
register
one
of
these
pesticides
than
to
register
a
conventional
pesticide.
In
fact,
new
biochemical
or
microbial
pesticides
are
often
registered
in
less
than
a
year,
compared
with
an
average
of
more
than
three
years
for
conventional
pesticides.

Until
1984,
data
requirements
were
based
on
longstanding
requirements
initially
put
in
place
when
the
U.
S.
Department
of
Agriculture
(
USDA)
and
the
Food
and
Drug
Administration
(
FDA)
regulated
pesticides.
However,
because
virtually
all
of
EPA's
decisions
relating
to
the
registration
of
pesticides
or
the
establishment
of
tolerances
depend
on
Agency
evaluation
of
scientific
studies,
EPA
has
throughout
the
years
developed
standardized
data
requirements
and
test
guidelines,
and
established
evaluation
procedures
and
peer
review
processes
to
ensure
the
quality
and
consistency
of
scientific
studies.

The
proposed
rule
outlines
to
applicants
the
data
that
would
appear
to
add
significant
information
and
value
to
the
registration
decision,
while
ensuring
that
the
registration
meets
or
exceeds
statutory
safety
standards.
By
codifying
these
data
requirements
that
are
currently
applied
on
a
case­
by­
case
basis
and
adding
few
additional
new
requirements,
the
Agency
will
be
able
to
predict
the
potential
risks
of
biochemical
and
microbial
pesticides
to
humans
and
the
environment
more
accurately.
Other
benefits
are
increased
efficiency
due
to
better
understanding
by
the
regulated
community
and
other
interested
parties
of
what
the
requirements
are.

These
changes,
by
streamlining
and
reducing
the
cost
of
registration
of
biopesticides,
will
help
manufacturers
bring
new
biopesticides
to
market.
This
will
allow
agricultural
producers
and
other
pesticide
users
to
increase
their
use
of
these
relatively
less­
risky
pesticides,
benefiting
human
health
and
the
environment
compared
to
the
use
of
alternative
conventional
pesticides.
36
7.2
Low­
Cost
Alternative:
Waive
(
for
Biochemical
Pesticides)
and
Reduce
by
50%
(
for
Microbial
Pesticides)
Certain
Proposed
Tier
I
Data
Requirements
The
low­
cost
alternative
would
waive
all
non­
target
organism
and
environmental
fate
Tier
I
data
requirements
for
biochemical
pesticides.
Under
the
low­
cost
alternative,
the
Agency
would
require
Tier
I
data
50
percent
less
of
the
time
for
microbial
pesticides
than
under
the
proposed
alternative.

Costs
The
estimated
total
cost
savings
of
this
approach
to
industry
(
additional
relief
through
waivers
and
less
stringent
Tier
I
data
requirements
compared
to
what
is
required
in
the
current
CFR)
is
about
$
3.20
million,
or
approximately
$
160,000
more
in
total
cost
savings
versus
the
proposed
option.

Benefits
This
option
would
likely
result
in
bringing
biochemical
and
microbial
pesticides
to
market
relatively
faster
than
for
conventional
pesticides
by
minimizing
and
streamlining
the
data
requirements
for
completing
the
registration
action.
The
data
required
under
the
current
practice
relies
on
the
data
requirements
in
the
existing
40
CFR
part
158
as
modified
by
current
policies
and
practices,
including
DCI's.
Entities
seeking
registration
of
a
pesticide
have
to
submit
applications
based
on
requirements
in
the
current
CFR
and
then
wait
for
the
Agency
to
determine
additional
data
needed
that
are
not
currently
in
the
CFR
for
each
biochemical
or
microbial
pesticide
registration
action
on
a
case­
by­
case
basis.
EPA
considers
all
of
the
possible
tests
used
to
support
pesticide
registrations,
processes
data
waiver
requests
as
necessary,
and
only
requires
those
tests
that
would
appear
to
add
significant
information
and
value
to
the
decision,
while
ensuring
that
the
registration
meets
or
exceeds
statutory
safety
standards.

Like
the
proposed
option,
this
option
would
be
more
efficient
in
terms
of
process
than
no
new
rule
at
all
because
most
of
the
data
requirements
would
be
known
in
advance,
thus
saving
delays
in
generating
data.
In
terms
of
data
requirements,
this
option
is
similar
to
the
proposed
approach
except
it
waives
or
significantly
reduces
certain
Tier
I
data
requirements
for
biochemical
and
microbial
pesticides.

EPA
believes
that
the
modified
and
newly
imposed
non­
target
organism
and
environmental
fate
Tier
I
data
requirements
(
that
are
in
the
proposed
approach,
but
not
in
this
low­
cost
option)
provide
a
necessary
basis
for
informed
decision­
making
on
biochemical
and
microbial
pesticide
registrations
and
are
worth
their
added
cost.
The
non­
target
organism
tests
monitor
the
effects
of
proposed
pesticides
on
non­
target
birds,
wild
mammals,
fish,
insects
and
plants.
The
environmental
fate
tests
are
used
to
assess
the
persistence
of
biopesticides
in
the
environment.
If
they
have
remain
in
the
environment
for
a
long
period
of
time
after
application,
there
is
increased
risk
for
having
unintended
consequences
beyond
the
effects
intended
when
the
pesticides
were
introduced
into
the
environment.
The
proposed
option
would
reduce
the
externalities
to
the
environment
and
risks
to
public
health
more
than
this
low­
cost
option.
37
7.3
High­
Cost
Alternative:
Require
Proposed
Tier
I
Data
100%
of
the
Time
Costs
The
total
annual
cost
of
this
option
is
estimated
to
be
an
increase
of
approximately
$
3.44
million
compared
to
an
estimated
cost
savings
of
$
3.04
million
under
the
proposed
approach.
A
key
component
of
the
proposed
changes
to
40
CFR
parts
L&
M
is
the
flexibility
of
Agency
scientists
to
determine
based
on
the
pesticide
being
registered
what
data
are
necessary
to
assess
its
negative
effects
on
human
health
and
the
environment.
In
terms
of
data
requirements,
this
approach
would
result
in
higher
costs
to
pesticide
registrants
and
increased
burden
to
the
Agency
compared
to
the
proposed
approach
by
requiring
all
Tier
I
test
results
to
be
reviewed,
despite
eliminating
the
need
for
the
use
of
Agency
resources
to
evaluate
waiver
requests.
Additionally,
EPA
believes
that
this
high­
cost
approach
would
raise
the
cost
of
registering
a
biochemical
or
microbial
pesticide
substantially,
resulting
in
fewer
products
being
registered
and
lessening
the
potential
for
these
biopesticides
to
provide
alternatives
to
more
toxic
or
harmful
conventional
pesticides
competing
in
the
marketplace.

Benefits
This
alternative,
by
requiring
even
more
data,
may
reduce
the
adverse
externalities
of
pesticides
and
unknown
risks
to
consumers
of
food
slightly
more
than
the
proposed
approach.
However,
the
benefits
of
this
additional
data
are
speculative,
because
if
certain
conditions
are
met,
then
these
additional
data
(
over
and
above
what
the
proposed
option
requires)
would
help
inform
registrations
decisions
very
little.
Furthermore,
if
the
higher
cost
of
registering
biochemical
or
microbial
pesticides
results
in
fewer
products
being
registered,
overall
human
health
and
environmental
risk
may
not
be
decreased
since
these
biopesticide
products
are
inherently
safer
than
conventional
pesticides
they
may
replace
or
partly
replace.

Like
the
proposed
option,
this
option
would
be
more
efficient
in
terms
of
process
than
no
new
rule
at
all,
because
most
of
the
data
requirements
would
be
known
in
advance,
thus
saving
delays
in
generating
data.
This
alternative
approach
all
but
ensures
availability
at
the
time
of
registration
of
the
full
suite
of
test
information
required,
eliminating
the
time
consuming
step
of
requesting
that
the
registrant
generate
additional
data
if
it
determined
to
be
needed.

EPA
believes
that
the
cost
of
requiring
the
Tier
I
data
100
percent
of
the
time
for
all
biochemical
and
microbial
registrations
would
be
too
high
to
warrant
the
modest
benefits
of
marginally
valuable
information.
Further,
the
potential
reduction
in
registrations
of
biopesticides,
which
are
generally
comparatively
safe
alternatives
to
conventional
pesticides,
would
be
an
undesirable
outcome
of
changes
to
40
CFR
part
158.

8
SMALL
BUSINESS
IMPACTS
This
section
describes
step
6
in
the
economic
analysis
or
the
method
for
defining
and
identifying
the
small
entities
affected
by
the
40
CFR
part
158
subparts
L&
M
proposed
changes.
This
approach
uses
the
industry
profile
described
in
Section
4,
and
includes
an
analysis
of
the
number
and
percentage
of
entities
incurring
economic
impacts.
The
incremental
cost
savings
of
38
registration
actions
for
each
small
biochemical
and
microbial
pesticide
firm
is
estimated
and
compared
to
its
annual
sales
revenue
to
determine
the
incremental
impact
as
a
percent
of
sales
revenue.

8.1
Regulatory
Overview
The
Regulatory
Flexibility
Act
(
RFA)
of
1980
and
its
1996
amendment,
the
Small
Business
Regulatory
Enforcement
Fairness
Act
(
SBREFA),
requires
that
special
consideration
be
given
to
the
effects
of
proposed
regulations
on
small
business
entities.
The
regulations
require
that
a
determination
be
made
as
to
whether
the
proposed
regulation
will
have
a
significant
impact
on
a
substantial
number
of
small
entities.
EPA
measured
the
economic
impact
by
the
annual
compliance
costs
as
a
percentage
of
sales
to
assess
the
small
business
impacts.

8.2
Categorization
of
Small
Businesses
The
Small
Business
Act
authorizes
the
Small
Business
Administration
(
SBA)
to
establish
the
definition
of
a
small
business.
The
SBA
has
set
size
standards
under
the
North
American
Industrial
Classification
System
(
NAICS),
using
various
thresholds
on
employee
number
and
revenue
amount,
which
vary
by
NAICS
code.
In
determining
the
size
of
a
firm,
the
SBA
applies
its
standards
to
the
parent
level
of
a
business
entity.
1
The
SBA
also
bases
its
determinations
on
the
primary
industry
of
the
firm.
In
this
analysis,
the
firm
=

s
primary
NAICS
code
is
assumed
to
be
its
primary
industry,
and
the
definition
of
small
business
is
determined
by
the
SBA
based
on
maximum
number
of
employees
or
sales
for
small
businesses
in
each
industry
sector,
as
defined
by
a
6­
digit
NAICS
code.
For
example,
entities
defined
as
Pesticide
and
Other
Agricultural
Chemical
Manufacturing
(
325320)
are
small
if
they
employ
500
or
fewer
people;
Pharmaceutical
Preparation
Manufacturing
(
325412)
entities
are
small
if
they
employ
750
or
fewer
people.
Other
entities
are
defined
by
sales.
For
example,
Testing
Laboratories
(
541380)
are
small
entities
if
they
have
annual
sales
of
$
5.0
million
or
less.

1
Specifically,
the
SBA
treats
a
firm
that
has
a
substantial
portion
of
its
assets
and/
or
liabilities
shared
with
a
predecessor
entity
as
part
of
that
predecessor
entity.
8.2.1
Estimation
of
the
Number
of
Small
Businesses
As
discussed
in
Section
6,
EPA
used
the
following
databases
to
estimate
the
number
of
businesses
registering
pesticides:

°
PRATS,
which
tracks
registration
actions.
°
OPPIN,
which
includes
all
registered
pesticide
products
and
their
registrants.
°
D&
B
Market
Spectrum
Web,
which
includes
financial
and
firm
size
data
on
many
firms.
39
The
PRATS
sample
includes
51
firms
that
would
have
incurred
incremental
cost
savings
as
a
result
of
the
proposed
rule
had
it
been
in
place
from
1997
through
2004.
Of
these,
40
ultimate
parent
entities
were
identified.
Eleven
firms
had
insufficient
D&
B
financial
data
to
be
classified
by
SBA
size
definitions.
Table
8­
1
shows
the
size
distribution
of
the
40
parent
entities
in
the
PRATS
sample.
Of
these
40
parent
companies,
58
percent
are
small
and
42
percent
are
large.

Table
8­
1:
Companies
in
the
PRATS
Sample
by
SBA
Size
Size1
Number
of
Parent
Companies
Percentage
of
Parent
Companies
Small
23
57.5%

Large
17
42.5%

Total
402
100.00%

Source:
OPPIN,
2005;
Dun
&
Bradstreet
Market
Spectrum
Web,
2005;
SBA
Size
Standards,
2005
1
Size
definitions
vary
according
to
the
SBA
small
business
definition
associated
with
each
NAICS
code.
2
Eleven
companies
did
not
have
sufficient
Dun
&
Bradstreet
(
D&
B)
financial
data
to
be
classified
by
SBA
size
definitions.

Out
of
the
247
company
entries
initially
considered
in
the
profile
universe,
sales
and
revenue
data
could
not
be
found
for
26
companies
through
D&
B,
infoUSA.
com,
and
an
Internet
search.
The
remaining
221
entries
were
found
to
have
200
separate
parent
companies
(
i.
e.,
global
ultimate
DUNS
numbers).
One
of
these,
the
USDA
Forest
Service,
is
a
government­
related
entity.
This
leaves
a
total
of
199
unique
parent
companies
with
sufficient
data
available
to
classify
them
as
either
small
or
large
businesses
according
to
the
SBA
company
size
definitions.

8.2.2
Sales
and
Employees
Table
8­
2
shows
the
average
sales
and
average
number
of
employees
for
the
parent
entities
in
the
OPPIN
data
set.
The
average
sales
for
small
parent
entities
are
$
9.97
million
and
the
average
sales
for
large
parent
entities
are
$
7.64
billion.
The
average
number
of
employees
for
small
parent
entities
is
46,
and
the
average
number
of
employees
for
large
parent
entities
is
18,784.

Table
8­
2:
Average
Sales
and
Employees
B
PPIS
Data
Set
Company
Size
Number
of
Parent
Companies
Average
Sales
Average
Number
of
Employees
Small
127
$
9,970,000
46
Large
72
$
7,637,000,000
18,784
Source:
OPPIN,
2005;
Dun
&
Bradstreet,
2005
40
Table
8­
3
shows
the
distribution
of
annual
revenues
and
employees,
by
SBA
threshold
level,
for
the
biochemical
and
microbial
pesticide
industry.

Table
8­
3:
Number
of
Entities
in
Sample
per
SBA
Category
from
PRATS
Sample
Employee
Size
Thresholds
SBA
Threshold
Criteria
for
Defining
Small
Businesses
Number
of
Sample
Firms
Percentage
of
Sample
Firms
100
or
fewer
employees
118
59%

101­
500
employees
23
11.5%

501­
750
or
fewer
employees
3
1.5%

751­
1000
or
fewer
employees
2
1%

1,001­
1,500
or
fewer
employees
0
0%

Annual
Revenue
Thresholds
SBA
Threshold
Criteria
for
Defining
Small
Businesses
Number
of
Sample
Firms
Percentage
of
Sample
Firms
$
4.0
million
or
less
in
revenue
86
44%

$
4.0­
5.0
million
in
revenue
5
2.5%

$
5.0­
6.0
million
in
revenue
3
1.5%

$
6.0­
7.0
million
in
revenue
1
0.5%

$
7.0­
12.0
million
in
revenue
10
5%

$
12.0­
18.5
million
in
revenue
6
3%

$
18.5­
20.0
million
in
revenue
0
0%

Source:
OPPIN,
2005;
Dun
&
Bradstreet,
2005
8.3
Small
Business
Impact
As
discussed
above,
the
historical
data
suggest
that
the
23
entities
in
the
PRATS
sample
would
have
incurred
cost
savings
under
the
rule
over
the
8­
year
1997
to
2004
period.
However,
the
number
of
small
entities
that
are
potentially
subject
to
the
regulation
is
actually
much
larger.
In
fact,
any
firm
that
might
register
or
hold
a
registration
for
a
biochemical
or
microbial
pesticide
would
be
subject
to
the
proposed
rule
once
it
is
final.
Therefore,
the
number
of
small
entities
currently
subject
to
the
proposed
rule
is
equal
to
the
number
of
small
entities
in
the
OPPIN
biochemical
and
microbial
pesticide
registrant
universe.
In
order
to
determine
the
number
of
small
entities
that
will
have
compliance
costs
over
a
given
cost­
revenue
threshold,
it
is
necessary
to
consider
all
small
entities
subject
to
the
regulation,
even
those
that
are
expected
to
incur
no
additional
cost.
For
the
247
biochemical
and
microbial
pesticide
companies
in
the
OPPIN
database,
EPA
was
able
to
identify
the
SBA
size
definition
of
200.
Of
these
companies,
127
were
small
businesses.
Using
the
same
ratio,
the
Agency
estimates
there
are
approximately
157
small
entities
in
the
OPPIN
biochemical
and
microbial
pesticide
registrant
universe.

The
Agency
then
looked
at
the
number
of
entities
that
would
have
incurred
costs
under
the
rule
had
it
been
in
place
during
1997
to
2004.
The
PRATS
data
set
includes
51
entities.
For
those
entities
for
which
a
size
could
be
determined,
57.5
percent
were
small.
Assuming
that
57.5
percent
of
all
the
PRATS
entities
are
small,
EPA
estimated
that
29
regulated
small
entities
that
41
would
have
benefited
from
the
cost
savings
due
to
the
proposed
rule.
Most
of
the
estimated
157
small
entities
in
the
biochemical
and
microbial
pesticide
registrant
universe
are
not
expected
to
benefit
immediately
as
a
result
of
the
rule.
The
proposed
rule
is
expected
to
reduce
the
total
cost
of
biochemical
and
microbial
data
requirements
per
small
firm.
Table
8­
4
provides
the
cost
to
revenue
ratio
analysis
results
for
the
low
cost,
high
cost,
and
mean
cost
estimates.

Table
8­
4:
Incremental
Cost
Savings
for
Small
Firms
Potentially
Affected
by
the
Proposed
Rule
Number
of
Small
Companies
Percentage
of
Small
Companies
Measure
Low
Test
Costs
Mean
Test
Costs
High
Test
Costs
Low
Test
Costs
Mean
Test
Costs
High
Test
Costs
Compliance
cost
savings
>
0%
or
revenue
23
23
23
100%
100%
100%

Compliance
cost
savings
>
1%
of
revenue
12
11
10
52%
48%
43%

Compliance
cost
savings
>
5%
of
revenue
7
6
5
30%
26%
22%

Compliance
cost
savings
>
10%
of
revenue
5
3
3
22%
13%
13%

9
LIMITATIONS
OF
THE
ECONOMIC
ANALYSIS
The
important
cost
factors
of
this
rule
are
associated
with
the
increased
cost
of
generating
data
in
support
of
biochemical
and
microbial
pesticide
registrations,
offset
by
routinely
granted
data
waivers
based
on
inherently
lower
human
health
and
ecological
risks
of
these
products.
Estimating
these
cost
factors
is
uncertain
and
complicated
due
to
a
number
of
variables.

Unit
Test
Costs
Costs
for
guideline
studies
were
gathered
from
a
necessarily
limited
survey
of
commercial
labs
(
see
Appendix
A:
Test
Cost
Data
Used
to
Calculate
Guideline
Costs
for
Part
158
Subparts
L&
M
Rule).
Compared
to
labs
offering
testing
on
conventional
pesticides,
relatively
few
labs
offer
some
of
the
tests
required
for
biopesticide
registration.
EPA
could
not
locate
a
lab
that
could
estimate
test
costs
for
pathogenicity
(
guideline
no.
885.3000)
and
obtained
a
cost
estimate
for
this
data
requirement
from
the
National
Institutes
of
Health.
EPA
obtained
cost
quotes
from
between
two
and
six
labs
for
other
tests
not
required
for
conventional
pesticide
registration.
For
a
number
of
studies
there
is
a
wide
range
of
cost
estimates.
Although
the
Agency
is
not
in
a
position
to
know
the
particular
underlying
reasons
for
this,
presumably
it
is
grounded
in
typical
economic
considerations
tempered
by
the
particular
experience
that
labs
may
have
had
with
the
study
protocols.
Not
surveyed
were
in­
house
labs
that
many
companies
use.
Their
costs
might
be
expected
to
be
lower
than
an
independent
lab.

Frequency
of
Various
Tests
Being
Required
42
There
is
flexibility
for
complying
with
40
CFR
part
158
subparts
L&
M
requirements.
Agency
experience
shows
that
pesticides
and
their
uses
vary
widely.
Individual
chemical,
toxicological,
and
exposure
profiles
may
suggest
quite
different
risk
potential.
To
the
extent
practicable,
the
Agency
has
tried
to
guide
users
of
tables
with
the
proposed
data
requirements
to
the
applicable
requirements
by
including
use
categories
and
footnotes;
however,
the
utility
of
this
application
is
limited.
Ultimately,
in
certain
cases,
there
is
no
substitute
for
Agency
consultation
with
registrants
so
that
appropriate
A
alternate
@

approaches
or
data
can
be
considered
for
situations
that
do
not
exactly
fit
the
tables.

It
is
very
difficult
to
predict
the
extent
to
which
a
registrant
may
be
able
to
satisfy
a
data
requirement
through
a
waiver
request,
bridging
of
existing
data,
or
development
of
new
data
that
adequately
responds
to
the
data
requirement
without
performing
a
"
guideline
study."
In
estimating
costs
of
newly
codified
data
requirements,
the
Agency
has
relied
upon
scientific
judgment
of
experienced
staff
to
produce
reasonable
estimates
of
how
often
we
expect
to
receive
newly
generated
guideline
studies
to
satisfy
the
proposed
data
requirements.

Number
of
Future
Requested
Registration
Actions
Future
requested
registration
actions
may
not
closely
reflect
the
past
eight
years
of
actions
that
the
Agency
used
as
a
baseline
for
its
estimate
to
predict
future
actions.
This
could
be
due
to
a
number
of
factors
including
unforeseen
changes
in
markets
or
scientific
knowledge.

Other
limitations
include:

°
Industry
Structure.
The
analysis
was
based
on
2005
financial
data,
but
currently
there
is
a
trend
where
large
companies
are
taking
over
smaller
ones.
For
example,
several
large
companies
have
purchased
others
and
become
vertically
integrated,
leaving
only
a
few
large
companies.
°
Sales
Data.
Forty­
seven
of
the
247
active
registrants
in
the
biochemical
and
microbial
pesticide
industry
could
not
be
classified
as
large
or
small
entities
with
sales
data.
Therefore,
the
analysis
was
limited
to
an
analysis
of
the
200
parent
firms
with
sufficient
data
available.
°
Cost
Incidence.
Because
data
limitations
made
it
difficult
to
determine
precisely
when
and
who
bears
the
costs,
several
assumptions
were
made
as
listed
below.
Two
of
these
assumptions
(
annual
average
costs
and
average
test
costs)
tend
to
spread
the
costs
and
cost
savings
to
a
greater
number
of
entities
at
a
lower
cost
per
firm.
Not
allowing
for
data
cost
sharing
has
the
opposite
effect.
EPA
was
not
able
to
determine
whether
the
net
effect
of
these
assumptions
results
in
cost
estimates
that
are
overly
concentrated
or
too
spread
out.

a.
Data
Cost
Sharing.
The
analysis
assumes
that
the
registrants
initiating
registration
actions
would
pay
the
full
costs
of
the
data
required
by
these
actions.
It
is
assumed
many
other
registrants
are
able
to
cite
data,
therefore,
the
cost
of
data
savings
may
be
greater
and
distributed
more
widely,
resulting
in
a
larger
number
of
entities
incurring
greater
cost
savings
than
estimated
above.
43
b.
Annual
Average
Costs.
EPA
averaged
the
costs
over
an
eight­
year
period
(
1997
to
2004).
Therefore,
in
any
given
year
there
could
be
greater
or
fewer
entities
bearing
costs
and
greater
or
fewer
data
waivers
requested
and
accepted
than
what
was
estimated.

c.
Average
Test
Costs.
Many
of
the
tests
are
not
required
for
all
biochemical
and
microbial
registration
actions.
EPA
estimated
average
test
costs
per
registration
action
by
multiplying
the
test
costs
times
the
percent
of
time
the
tests
are
likely
to
be
required.
In
reality,
specific
registration
actions,
which
require
most
of
the
tests,
may
be
more
expensive,
while
others
requiring
few
tests
may
be
less
expensive
than
the
averages
estimated.

In
spite
of
these
limitations,
EPA
concludes
that
the
potential
impacts
of
the
proposed
rule
on
small
businesses
suggests
that
it
will
directly
benefit
each
of
the
limited
number
of
small
entities
affected
because
all
of
the
potentially
impacted
firms
are
expected
to
experience
an
overall
total
cost
decrease.
Since
the
likely
impact
of
this
proposed
rule
on
businesses
overall
is
expected
to
be
minimal
yet
beneficial,
the
Agency
believes
that
little
or
no
effect
on
the
availability
of
pesticides
to
users
is
likely.
On
balance,
the
Agency
believes
that
the
cost
savings
resulting
from
the
proposed
changes
to
40
CFR
part
158
subparts
L&
M
can
be
realized
without
compromising
the
protection
of
human
health
and
the
environment.

Impacts
of
Waivers
It
is
possible
that
the
future
stream
of
waiver
applications
will
contain
biochemical
or
microbial
pesticides
with
different
chemical
characteristics
that
make
the
historic
waiver
patterns
a
poor
predictor
of
the
future.
In
addition,
the
eight­
year
historical
baseline
record
of
data
waivers
(
1997
to
2004)
has
a
relatively
small
amount
of
data
in
several
data
requirement
categories
so
it
may
not
be
representative
of
the
entire
data
requirement
category
population.
Finally,
because
waivers
are
only
granted
upon
request,
it
is
possible
that
some
tests
were
done
that
could
have
been
waived
if
the
submitter
had
requested
such
consideration.
44
10
ESTIMATION
OF
AGENCY
BURDEN
EPA
would
incur
costs
primarily
in
reviewing
the
additional
or
modified
data
required
and
processing
waivers
requested
in
association
with
the
proposed
change
in
40
CFR
part
158
subparts
L&
M
data
requirements.
Table
10­
1
summarizes
the
typical
annual
burden
and
cost
of
the
proposed
rule
to
the
Agency
per
biochemical
or
microbial
pesticide
registration.
This
estimate
was
based
on
relevant
Agency
burden
data
modified
from
the
current
Section
3
Data
Acquisition
for
Registration
ICR
(
OMB
Control
No.
2070­
0122).

Table
10­
1:
Biochemical
or
Microbial
Registration
Burden
and
Costs
Due
to
Proposed
Changes
to
40
CFR
Part
158
Subparts
L&
M
Per
Registration
Action
Burden
Hours
(
per
year)
Total
Burden
Activities
Mgmt.
$
99/
hr.
Tech.
$
72/
hr
Clerical
$
34/
hr
Hours
Costs
$

Answer
registrants'
questions
0
14
0
14
$
1,008
In­
process
data
and
waiver
submissions
0
30
0
30
$
2,160
Analyze
data
and
waiver
requests
15
217
0
232
$
17,109
Record
and
store
information
0
0
16
16
$
544
TOTAL
15
261
16
292
$
20,821
Source:
Hours
rates:
Application
for
New
or
Amended
Pesticide
Registration
(
Section
3),
OMB
Control
No.
2070­
060,
pending
EPA
ICR
No.
0277.14.

In
Section
5
the
annual
estimated
number
of
biochemical
and
microbial
pesticide
registrations
was
calculated
to
be
8.6 
rounded
to
nine
registration
actions
for
the
purpose
estimating
Agency
burden
(
six
biochemical
pesticides
plus
2.6
microbial
pesticides).
Multiplied
by
the
burden
and
cost
per
registration,
the
estimated
total
annual
Agency
burden
and
costs
for
addressing
the
changes
in
data
requirements
and
for
processing
waivers
to
be
approximately
$
160,000.
45
REFERENCES
Office
of
Management
and
Budget
(
OMB).
2003.
Circular
A­
4.
September.

U.
S.
EPA.
1998.
40
CFR
Part
158.

U.
S.
EPA.
2000.
Guidelines
for
Preparing
Economic
Analyses.
September.

U.
S.
EPA.
1999.
Revised
Interim
Guidance
for
EPA
Rule
Writers:
Regulatory
Flexibility
Act
as
amended
by
the
Small
Business
Regulatory
Enforcement
Act.
March.

U.
S.
EPA.
2005.
Analysis
of
Data
Requirements
for
Biochemical
and
Microbial
Pesticides
from
1997­
2004.
April.

U.
S
EPA.
2005.
Supporting
Statement
for
an
Information
Collection
Request.
Application
for
New
and
Amended
Pesticide
Registration.
OMB
No.
2070­
0060.
EPA
No.
0277.14
(
pending
approval).
March.
46
APPENDIX
A:
TEST
COST
DATA
USED
TO
CALCULATE
GUIDELINE
COSTS
FOR
40
CFR
PART
158
SUBPARTS
L&
M
Three
types
of
test
cost
estimates
were
used
to
analyze
the
cost
of
compliance
with
the
proposed
rule
and
alternative
data
requirements
for
biochemical
and
microbial
pesticides.
The
three
types
of
test
cost
estimates
are
described
below:

°
New
test
cost
estimates
Test
cost
estimates
collected
from
laboratories
by
SciReg,
Inc.
from
January
through
March
2005;
°
Updated
test
cost
estimates
originally
collected
in
1993,
which
were
reviewed
and
adjusted
on
a
case­
by­
case
basis
based
on
best
professional
judgment
from
SciReg,
Inc.
°
Current
test
cost
estimates
taken
from
the
conventional
pesticides
40
CFR
part
158
economic
analysis
supporting
documentation.

Below
is
a
summary
of
all
the
test
cost
data
used
in
economic
analysis
of
the
proposed
changes
to
40
CFR
part
158
subparts
L&
M.

Test
Cost
Data
for
Biochemical
Pesticide
Data
Requirements
OPPTS
Guideline
Cost
Estimate
Low
Cost
High
Cost
Average
Cost
830.1700
New
Preliminary
analysis
$
4,000
$
21,000
$
12,500
$
4,750
$
12,825
$
8,788
$
30,000
$
80,000
$
55,000
$
11,500
$
11,500
$
11,500
$
15,000
$
145,000
$
80,000
$
15,000
$
30,000
$
22,500
Average
$
31,715
830.1750
New
Certified
limits
$
165
$
330
$
248
Average
$
248
830.1800
New
Enforcement
analytical
method
$
1,000
$
1,000
$
1,000
$
5,225
$
5,225
$
5,225
$
25,000
$
25,000
$
25,000
$
3,000
$
3,000
$
3,000
$
10,000
$
80,000
$
45,000
$
12,000
$
15,000
$
13,500
Average
$
15,454
830.1900
New
Submittal
of
samples
$
330
$
660
$
495
Average
$
495
830.6302
Updated
Color
$
400
$
1,000
$
700
47
OPPTS
Guideline
Cost
Estimate
Low
Cost
High
Cost
Average
Cost
830.6303
Updated
Physical
State
$
400
$
1,000
$
700
830.6304
Updated
Odor
$
400
$
1,000
$
700
830.6313
Updated
Stability
to
normal
and
elevated
temperatures
$
4,500
$
12,000
$
8,250
830.6315
Updated
Flammability
$
1,000
$
3,000
$
2,000
830.6317
Updated
Storage
Stability
$
8,000
$
15,000
$
11,500
830.6319
Updated
Miscibility
$
700
$
1,500
$
1,100
830.6320
Updated
Corrosion
characteristics
$
2,000
$
3,500
$
2,750
830.7000
Updated
pH
$
500
$
1,000
$
750
830.7050
Current
UV/
Visible
Absorption
$
2,000
$
2,000
$
2,000
$
750
$
750
$
750
$
1,000
$
1,000
$
1,000
$
1,412
$
1,412
$
1,412
$
4,000
$
4,000
$
4,000
$
200
$
1,000
$
600
$
2,500
$
2,500
$
2,500
$
3,915
$
3,915
$
3,915
Average
$
2,022
830.7100
Updated
Viscosity
$
800
$
2,000
$
1,400
830.7200
Updated
Melting
point/
melting
range
$
800
$
1,600
$
1,200
830.7220
Updated
Boiling
point/
boiling
range
$
1,000
$
2,000
$
1,500
830.7300
Updated
Density/
relative
density/
bulk
density
$
800
$
2,000
$
1,400
830.7520
Current
Particle
size
$
1,500
$
1,500
$
1,500
$
1,000
$
1,000
$
1,000
48
OPPTS
Guideline
Cost
Estimate
Low
Cost
High
Cost
Average
Cost
$
1,500
$
1,500
$
1,500
Average
$
1,333
830.7550
Current
Partition
Coefficient
(
n­
Octanol/
water)
$
4,000
$
6,000
$
5,000
$
5,075
$
5,075
$
5,075
$
7,500
$
8,000
$
7,750
$
3,000
$
5,000
$
4,000
$
7,500
$
7,500
$
7,500
Average
$
5,865
830.7560
Current
Partition
Coefficient
(
n­
Octanol/
water)
$
10,000
$
11,000
$
10,500
$
3,000
$
6,000
$
4,500
$
5,000
$
5,000
$
5,000
Average
$
6,667
830.7570
Current
Partition
Coefficient
(
n­
Octanol/
water)
$
3,500
$
3,500
$
3,500
$
5,000
$
5,000
$
5,000
$
3,457
$
3,457
$
3,457
$
6,000
$
6,000
$
6,000
$
3,000
$
6,000
$
4,500
$
3,500
$
3,500
$
3,500
$
3,000
$
5,000
$
4,000
$
5,145
$
5,145
$
5,145
Average
$
4,388
830.7550,
830.7560,
830.7570
Current
Partition
Coefficient
(
n­
Octanol/
water)
(
The
average
cost
of
these
three
guidelines
was
averaged
to
find
an
single
PartitionCoefficient
cost
estimate.)
$
6,000
$
7,333
$
6,667
$
6,041
$
6,603
$
6,322
$
4,075
$
4,700
$
4,388
Average
$
5,792
830.7840
Updated
Water
solubility:
column
elution
method;
shake
flask
method
$
5,000
$
7,000
$
6,000
830.7950
Updated
Vapor
pressure
$
10,000
$
20,000
$
15,000
835.1230
Current
Adsorption/
desorption
$
30,000
$
30,000
$
30,000
$
8,000
$
12,000
$
10,000
$
18,000
$
20,000
$
19,000
$
8,000
$
12,000
$
10,000
$
45,000
$
45,000
$
45,000
$
28,500
$
28,500
$
28,500
Average
$
23,750
49
OPPTS
Guideline
Cost
Estimate
Low
Cost
High
Cost
Average
Cost
835.1240
Current
Adsorption/
desorption­
Column
leaching
$
70,000
$
70,000
$
70,000
$
7,000
$
15,000
$
11,000
$
27,000
$
30,000
$
28,500
$
65,000
$
105,000
$
85,000
$
39,400
$
39,400
$
39,400
Average
$
46,780
835.1410
Updated
Volatility
$
40,000
$
50,000
$
45,000
835.2120
Current
Hydrolysis
$
30,000
$
40,000
$
35,000
$
12,200
$
27,900
$
20,050
$
15,600
$
15,600
$
15,600
$
10,000
$
16,000
$
13,000
$
35,000
$
50,000
$
42,500
Average
$
25,230
835.2240
Current
Photodegradation
in
water
$
30,000
$
30,000
$
30,000
$
42,000
$
45,000
$
43,500
$
45,000
$
60,000
$
52,500
$
65,500
$
65,500
$
65,500
Average
$
47,875
835.2410
Current
Photodegradation
in
the
Soil
$
42,000
$
45,000
$
43,500
$
40,000
$
40,000
$
40,000
$
45,000
$
65,000
$
55,000
$
34,000
$
45,000
$
39,500
$
17,600
$
17,600
$
17,600
$
58,500
$
58,500
$
58,500
Average
$
42,350
835.4100
Current
Aerobic
Soil
Metabolism
$
109,500
$
109,500
$
109,500
$
90,000
$
120,000
$
105,000
$
76,000
$
80,000
$
78,000
$
85,000
$
85,000
$
85,000
Average
$
94,375
835.4300
Current
Aerobic
Aquatic
Metabolism
$
48,000
$
60,000
$
54,000
$
41,500
$
41,500
$
41,500
$
34,000
$
45,000
$
39,500
$
42,900
$
42,900
$
42,900
Average
$
44,475
850.1010
Updated
Acute
toxicity
freshwater
invertebrates
50
OPPTS
Guideline
Cost
Estimate
Low
Cost
High
Cost
Average
Cost
$
14,000
$
20,000
$
17,000
850.1025,
35,
45,
55
Current
Marine
and
Estuarine
Animal
Testing
$
6,100
$
27,700
$
16,900
$
7,200
$
28,600
$
17,900
$
7,300
$
35,200
$
21,250
$
9,600
$
39,400
$
24,500
Average
$
20,138
850.1075
Updated
Freshwater
fish
toxicity
$
14,000
$
20,000
$
17,000
850.1300
Current
Aquatic
animal
testing
(
fish
early
life
stage
and
aquatic
invertebrates)
$
64,100
$
142,600
$
103,350
$
73,700
$
153,700
$
113,700
$
68,400
$
156,900
$
112,650
$
87,100
$
198,000
$
142,550
Average
$
118,063
850.1350
Current
Aquatic
animal
testing
(
myside
chronic
toxicity)
$
14,000
$
14,000
$
14,000
$
25,000
$
50,000
$
37,500
$
56,000
$
59,000
$
57,500
Average
$
36,333
850.1400
Current
Aquatic
animal
testing
(
fish
early
life
stage
­
freshwater)
$
51,897
$
51,897
$
51,897
$
47,000
$
50,000
$
48,500
$
35,000
$
35,000
$
35,000
$
14,000
$
30,000
$
22,000
$
18,000
$
40,000
$
29,000
Average
$
37,279
850.1500
Current
Aquatic
Field
Animal
Testing
$
250,000
$
700,000
$
475,000
$
500,000
$
600,000
$
550,000
Average
$
512,500
850.1950
Current
Aquatic
Field
Animal
Testing
$
250,000
$
700,000
$
475,000
$
500,000
$
600,000
$
550,000
Average
$
512,500
850.2100
Current
Avian
Oral
Toxicity
$
6,400
$
13,800
$
10,100
Average
$
10,100
850.2200
Current
Avian
Dietary
Toxicity
$
5,940
$
5,940
$
5,940
$
2,000
$
2,000
$
2,000
51
OPPTS
Guideline
Cost
Estimate
Low
Cost
High
Cost
Average
Cost
$
11,000
$
12,000
$
11,500
Average
$
6,480
850.2300
Current
Avian
Reproduction
$
121,000
$
215,500
$
168,250
Average
$
168,250
850.2400
Updated
Terrestrial
wildlife
testing
(
wild
mammal
testing)
$
20,000
$
50,000
$
35,000
850.2500
New
Terrestrial
wildlife
field
testing
$
304,000
$
304,000
$
304,000
$
700,000
$
800,000
$
750,000
Average
$
527,000
850.3040
Current
Non­
target
Insect
Testing
(
Field
Testing
for
Pollinators)
$
30,000
$
65,000
$
47,500
Average
$
47,500
850.3040
Updated
Non­
target
insect
testing
$
30,000
$
65,000
$
47,500
850.4100
Current
Seedling
emergence,
Tier
I
$
8,000
$
15,000
$
11,500
$
13,000
$
13,000
$
13,000
$
7,500
$
8,500
$
8,000
$
26,000
$
26,000
$
26,000
Average
$
14,625
850.4150
Current
Vegetative
vigor,
Tier
I
$
8,000
$
15,000
$
11,500
$
18,000
$
18,000
$
18,000
$
7,500
$
8,500
$
8,000
$
26,000
$
26,000
$
26,000
Average
$
15,875
850.4225
Current
Seedling
emergence,
Tier
II
$
10,000
$
20,000
$
15,000
$
22,000
$
22,000
$
22,000
$
13,000
$
16,000
$
14,500
$
30,000
$
30,000
$
30,000
Average
$
20,375
850.4250
Current
Vegetative
vigor,
Tier
II
$
12,000
$
25,000
$
18,500
$
35,000
$
35,000
$
35,000
$
13,000
$
16,000
$
14,500
$
30,000
$
30,000
$
30,000
Average
$
24,500
850.4300
New
Terrestrial
plants
field
study,
Tier
III
52
OPPTS
Guideline
Cost
Estimate
Low
Cost
High
Cost
Average
Cost
$
150,000
$
250,000
$
200,000
$
90,000
$
90,000
$
90,000
$
67,450
$
67,450
$
67,450
$
80,000
$
100,000
$
90,000
Average
$
111,863
850.4450
New
Aquatic
plants
field
study,
Tier
III
$
144,000
$
144,000
$
144,000
$
57,000
$
79,800
$
68,400
$
120,000
$
150,000
$
135,000
Average
$
115,800
860.1100
Updated
Chemical
identity
$
500
$
2,000
$
1,250
860.1200
Updated
Directions
for
use
$
3,000
$
5,000
$
4,000
860.1300
Current
Nature
of
the
residue
in
plant
$
90,000
$
110,000
$
100,000
$
100,000
$
100,000
$
100,000
Average
$
100,000
860.1300
Current
Nature
of
the
residue
in
livestock
$
90,000
$
145,000
$
117,500
$
90,000
$
110,000
$
100,000
$
100,000
$
100,000
$
100,000
Average
$
105,833
860.1340
Current
Residue
analytical
method,
plants
$
25,000
$
35,000
$
30,000
$
16,000
$
21,000
$
18,500
$
25,000
$
25,000
$
25,000
$
15,000
$
15,000
$
15,000
Average
$
22,125
860.1340
Current
Residue
analytical
method,
livestock
$
165,000
$
260,000
$
212,500
$
35,000
$
45,000
$
40,000
$
26,000
$
32,000
$
29,000
$
25,000
$
25,000
$
25,000
$
20,000
$
22,000
$
21,000
Average
$
65,500
860.1360
Current
Multiresidue
method
$
15,000
$
20,000
$
17,500
$
10,000
$
15,000
$
12,500
$
42,000
$
42,000
$
42,000
Average
$
24,000
860.1400
Current
Magnitude
of
residue,
water
53
OPPTS
Guideline
Cost
Estimate
Low
Cost
High
Cost
Average
Cost
$
30,000
$
35,000
$
32,500
$
75,000
$
75,000
$
75,000
Average
$
53,750
860.1400
Current
Magnitude
of
residue,
fish
$
78,000
$
130,000
$
104,000
Average
$
104,000
860.1400
Current
Magnitude
of
residue,
irrigated
crops
$
25,000
$
35,000
$
30,000
$
6,000
$
6,000
$
6,000
Average
$
18,000
*
Assumed
three
commodities
tested.
$
54,000*

860.1460
Current
Magnitude
of
residue
­
food­
handling
establishments
$
180,000
$
230,000
$
205,000
Average
$
205,000
860.1480
Current
Magnitude
of
residue
­
meat/
milk/
poultry/
eggs
$
185,000
$
185,000
$
185,000
$
180,000
$
200,000
$
190,000
$
72,000
$
72,000
$
72,000
Average
$
149,000
860.1500
Current
Magnitude
of
residue
­
crop
field
trials
$
155,000
$
185,000
$
170,000
$
200,000
$
250,000
$
225,000
$
96,000
$
96,000
$
96,000
Average
$
163,667
860.1520
Current
Magnitude
of
residue
­
processed
food/
feed
$
24,000
$
28,000
$
26,000
$
30,000
$
40,000
$
35,000
$
44,000
$
44,000
$
44,000
Average
$
35,000
860.1540
Current
Magnitude
of
residue
­
anticipated
residues
$
10,000
$
20,000
$
15,000
Average
$
15,000
860.1550
Current
Magnitude
of
residue
­
proposed
tolerance
$
4,125
$
6,600
$
5,363
Average
$
5,363
860.1560
Current
Reasonable
grounds
in
support
of
the
petition
$
5,000
$
15,000
$
10,000
Average
$
10,000
870.1100
Current
Acute
oral
toxicity
$
1,000
$
2,500
$
1,750
$
1,239
$
1,239
$
1,239
54
OPPTS
Guideline
Cost
Estimate
Low
Cost
High
Cost
Average
Cost
$
4,500
$
4,500
$
4,500
$
5,000
$
10,000
$
7,500
$
4,800
$
4,800
$
4,800
$
1,050
$
1,050
$
1,050
Average
$
3,473
870.1200
Updated
Acute
dermal
toxicity
$
1,000
$
3,000
$
2,000
870.1300
Updated
Acute
inhalation
toxicity
­
rat
$
1,000
$
3,000
$
2,000
870.2400
Updated
Primary
Eye
Irritation
$
1,000
$
3,000
$
2,000
870.2500
Updated
Acute
dermal
irritation
$
1,000
$
3,000
$
2,000
870.2600
Updated
Dermal
Sensitization
$
6,000
$
10,000
$
8,000
870.3100
Current
90­
day
oral
(
rodent)
$
76,000
$
76,000
$
76,000
$
87,000
$
87,000
$
87,000
$
130,441
$
138,452
$
134,447
$
141,120
$
183,680
$
162,400
$
124,500
$
124,500
$
124,500
$
140,000
$
160,000
$
150,000
$
240,000
$
240,000
$
240,000
$
130,500
$
130,500
$
130,500
Average
$
138,106
870.3250
Current
90­
day
Dermal­
Rat
$
95,000
$
95,000
$
95,000
$
139,700
$
139,700
$
139,700
$
125,000
$
125,000
$
125,000
$
125,000
$
135,000
$
130,000
$
121,588
$
127,914
$
124,751
$
205,900
$
205,900
$
205,900
$
116,000
$
116,000
$
116,000
$
160,400
$
160,400
$
160,400
Average
$
137,094
870.3465
Updated
90­
Day
inhalation
(
rat)
$
250,000
$
350,000
$
300,000
870.3700
Current
Prenatal
development
toxicity
­
rat
preferably
$
68,640
$
68,640
$
68,640
$
92,900
$
92,900
$
92,900
$
95,900
$
95,900
$
95,900
$
66,100
$
66,100
$
66,100
55
OPPTS
Guideline
Cost
Estimate
Low
Cost
High
Cost
Average
Cost
$
48,465
$
50,779
$
49,622
$
87,900
$
87,900
$
87,900
Average
$
76,844
870.3800
Current
Multigenerational
reproduction
$
346,147
$
354,199
$
350,173
$
444,200
$
444,200
$
444,200
$
185,000
$
185,000
$
185,000
$
375,000
$
400,000
$
387,500
$
565,000
$
565,000
$
565,000
$
339,000
$
339,000
$
339,000
Average
$
378,479
870.4100
Updated
Chronic
oral
­
rodent
and
nonrodent
$
800,000
$
1,100,000
$
950,000
870.4200
Updated
Carcinogenicity
­
two
species
$
1,400,000
$
2,060,000
$
1,730,000
870.5100
Current
Bacterial
reverse
mutation
$
2,910
$
2,910
$
2,910
$
3,900
$
5,900
$
4,900
$
3,500
$
5,500
$
4,500
$
4,300
$
4,300
$
4,300
$
3,675
$
3,675
$
3,675
Average
$
4,057
870.5300
Current
In
vitro
mammalian
cell
gene
mutation
$
15,167
$
15,167
$
15,167
$
22,300
$
22,300
$
22,300
$
12,600
$
21,500
$
17,050
$
20,100
$
20,100
$
20,100
Average
$
18,654
870.5380
Current
Mammalian
spermatogonial
chromosome
aberration
$
20,196
$
20,196
$
20,196
$
24,600
$
24,600
$
24,600
$
13,350
$
13,350
$
13,350
Average
$
19,382
870.5385
Current
Mammalian
bone
marrow
chromosomal
aberration
$
17,971
$
17,971
$
17,971
$
33,200
$
33,200
$
33,200
$
53,500
$
53,500
$
53,500
$
32,000
$
32,000
$
32,000
$
13,350
$
13,350
$
13,350
Average
$
30,004
870.5395
Current
Mammalian
erythrocyte
micronucleus
$
10,611
$
10,611
$
10,611
$
17,800
$
19,200
$
18,500
56
OPPTS
Guideline
Cost
Estimate
Low
Cost
High
Cost
Average
Cost
$
44,600
$
44,600
$
44,600
$
17,800
$
17,800
$
17,800
$
18,000
$
18,000
$
18,000
$
13,350
$
13,350
$
13,350
Average
$
20,477
870.7200
Current
Companion
Animal
Safety
Data
$
123,000
$
123,000
$
123,000
$
110,000
$
110,000
$
110,000
$
200,000
$
270,000
$
235,000
Average
$
156,000
870.7800
Current
Immunotoxicity
$
72,129
$
72,129
$
72,129
$
39,000
$
43,333
$
41,167
Average
$
56,648
875.1000
New
Background
for
applicator
exposure
monitoring
No
cost
associated
with
this
guideline;
not
a
study.

875.1100
Current
Dermal
Outdoor
Exposure
$
250,000
$
250,000
$
250,000
$
85,000
$
85,000
$
85,000
$
50,000
$
100,000
$
75,000
$
60,000
$
100,000
$
80,000
$
85,000
$
85,000
$
85,000
$
225,000
$
225,000
$
225,000
$
250,000
$
500,000
$
375,000
Average
$
167,857
875.1200
Current
Dermal
Indoor
Exposure
$
200,000
$
200,000
$
200,000
$
125,000
$
125,000
$
125,000
$
50,000
$
70,000
$
60,000
$
150,000
$
400,000
$
275,000
$
45,000
$
75,000
$
60,000
$
85,000
$
85,000
$
85,000
$
60,000
$
100,000
$
80,000
Average
$
126,429
875.1300
Current
Inhalation
Outdoor
Exposure
$
250,000
$
250,000
$
250,000
$
85,000
$
85,000
$
85,000
$
250,000
$
500,000
$
375,000
$
85,000
$
85,000
$
85,000
$
60,000
$
100,000
$
80,000
$
250,000
$
150,000
$
200,000
$
50,000
$
100,000
$
75,000
Average
$
164,286
875.1400
Current
Inhalation
Outdoor
Exposure
57
OPPTS
Guideline
Cost
Estimate
Low
Cost
High
Cost
Average
Cost
$
200,000
$
200,000
$
200,000
$
125,000
$
125,000
$
125,000
$
150,000
$
400,000
$
275,000
$
50,000
$
70,000
$
60,000
$
85,000
$
85,000
$
85,000
$
60,000
$
100,000
$
80,000
$
45,000
$
75,000
$
60,000
Average
$
126,429
875.1500
Current
Biological
Monitoring
$
140,000
$
140,000
$
140,000
$
80,000
$
150,000
$
115,000
$
187,500
$
425,000
$
306,250
$
125,000
$
125,000
$
125,000
$
400,000
$
400,000
$
400,000
$
75,000
$
200,000
$
137,500
$
95,000
$
95,000
$
95,000
Average
$
188,393
875.1700
Current
Product
Use
Information
$
2,000
$
4,000
$
3,000
Average
$
3,000
880.1100
Current
Product
identity
$
165
$
300
$
233
Average
$
233
880.1200
Current
Manufacturing
process
$
165
$
1,650
$
908
Average
$
908
880.1400
Current
Formation
of
impurities
$
165
$
495
$
330
Average
$
330
880.3800
Updated
Immune
Response
$
70,000
$
100,000
$
85,000
880.4350
Updated
Non­
target
insect
testing
$
12,000
$
18,000
$
15,000
880.4425
Updated
Dispenser­
water
leaching
$
20,000
$
30,000
$
25,000
No
guideline
New
Hypersensitivity
incidents
$
330
$
1,320
$
825
Average
$
825
58
Test
Cost
Data
for
Microbial
Pesticide
Data
Requirements
OPPTS
Guideline
Cost
Estimate
Low
Cost
High
Cost
Average
Cost
830.6302
Updated
Color
$
400
$
1,000
$
700
830.6303
Updated
Physical
State
$
400
$
1,000
$
700
830.6304
Updated
Odor
$
400
$
1,000
$
700
830.6313
Updated
Stability
to
normal
and
elevated
temperatures
$
4,500
$
12,000
$
8,250
830.6317
Updated
Storage
Stability
$
8,000
$
15,000
$
11,500
830.6319
Updated
Miscibility
$
700
$
1,500
$
1,100
830.6320
Updated
Corrosion
characteristics
$
2,000
$
3,500
$
2,750
830.7000
Updated
pH
$
500
$
1,000
$
750
830.7100
Updated
Viscosity
$
800
$
2,000
$
1,400
830.7300
Updated
Density/
relative
density/
bulk
density
$
800
$
2,000
$
1,400
850.1950
Current
Aquatic
Field
Animal
Testing
$
250,000.00
$
700,000.00
$
475,000.00
$
500,000.00
$
600,000.00
$
550,000.00
Average
$
512,500
850.2500
New
Terrestrial
wildlife
field
testing
$
304,000
$
304,000
$
304,000
$
700,000
$
800,000
$
750,000
Average
$
527,000
850.2500a
Updated
Simulated
or
actual
field
tests
(
birds,
mammals)
$
500,000
$
700,000
$
600,000
850.2500b
Updated
Simulated
or
actual
field
tests
(
aquatic
organisms)
$
500,000
$
700,000
$
600,000
850.2500c
Updated
Simulated
or
actual
field
tests
(
insect
predators,
parasites)
$
75,000
$
100,000
$
87,500
59
OPPTS
Guideline
Cost
Estimate
Low
Cost
High
Cost
Average
Cost
850.2500d
Updated
Simulated
or
actual
field
tests
(
plants)
$
50,000
$
75,000
$
62,500
870.1100
New
Acute
oral
toxicity
$
1,000
$
2,500
$
1,750
$
1,239
$
1,239
$
1,239
$
4,500
$
4,500
$
4,500
$
5,000
$
10,000
$
7,500
$
4,800
$
4,800
$
4,800
$
1,050
$
1,050
$
1,050
Average
$
3,473
870.1200
Current
Acute
dermal
toxicity
$
2,500
$
7,000
$
4,750
870.1300
Current
Acute
inhalation
toxicity
$
4,000
$
20,000
$
12,000
870.2400
Current
Acute
eye
irritation
$
1,000
$
3,000
$
2,000
870.2500
Current
Acute
dermal
irritation
$
1,000
$
3,000
$
2,000
870.4200
New
Carcinogenicity
­
rats
$
1,092,500
$
1,121,000
$
1,106,750
$
1,220,750
$
1,220,750
$
1,220,750
$
750,000
$
750,000
$
750,000
$
1,100,000
$
1,100,000
$
1,100,000
$
826,500
$
855,000
$
840,750
$
859,700
$
859,700
$
859,700
$
650,000
$
650,000
$
650,000
$
850,000
$
850,000
$
850,000
Average
$
922,244
870.7800
Current
Immunotoxicity
$
39,000.00
$
43,333.33
$
41,166.67
$
72,128.57
$
72,128.57
$
72,128.57
Average
$
56,648
885.0001
New
Overview
of
microbial
pest
control
agents
No
cost
associated
with
this
guideline;
not
a
study.

885.1100
Updated
Product
Identity
$
2,000
$
8,000
$
5,000
885.1200a
Updated
Manufacturing
Process
$
2,000
$
5,000
$
3,500
885.1200b
Updated
Deposition
of
Sample
in
a
Nationally
recognized
culture
collection
$
2,000
$
5,000
$
3,500
60
OPPTS
Guideline
Cost
Estimate
Low
Cost
High
Cost
Average
Cost
885.1300
Updated
Discussion
of
formation
of
unintentional
ingredients
$
2,000
$
5,000
$
3,500
885.1400
Updated
Analysis
of
Samples
$
4,000
$
145,000
$
74,500
885.1500
Updated
Certification
of
Limits
$
200
$
500
$
350
885.2000
New
Background
for
residue
analysis
of
microbial
pest
control
agents
No
cost
associated
with
this
guideline;
not
a
study.

885.2100
New
Chemical
identity
$
495
$
825
$
660
Average
$
660
885.2200
New
Nature
of
the
residue
in
plants
$
100,000
$
100,000
$
100,000
$
95,000
$
95,000
$
95,000
$
130,000
$
130,000
$
130,000
Average
$
108,333
885.2250
New
Nature
of
the
residue
in
livestock
$
100,000
$
100,000
$
100,000
$
92,150
$
95,000
$
93,575
$
130,000
$
150,000
$
140,000
$
120,000
$
150,000
$
135,000
Average
$
117,144
885.2300
New
Residue
analytical
method,
plants
$
25,000
$
25,000
$
25,000
$
15,200
$
15,200
$
15,200
$
20,000
$
25,000
$
22,500
$
15,000
$
75,000
$
45,000
$
20,000
$
30,000
$
25,000
Average
$
26,540
885.2350
New
Residue
analytical
method,
livestock
$
25,000
$
25,000
$
25,000
$
38,950
$
38,950
$
38,950
$
20,000
$
25,000
$
22,500
$
15,000
$
79,000
$
47,000
$
75,000
$
150,000
$
112,500
$
15,000
$
20,000
$
17,500
Average
$
43,908
885.2400
New
Storage
stability,
plants
$
20,000
$
20,000
$
20,000
$
36,100
$
36,100
$
36,100
$
47,000
$
47,000
$
47,000
61
OPPTS
Guideline
Cost
Estimate
Low
Cost
High
Cost
Average
Cost
$
6,000
$
25,000
$
15,500
$
7,000
$
8,000
$
7,500
$
60,000
$
60,000
$
60,000
Average
$
31,017
885.2500
New
Magnitude
of
residue
­
plants
$
250,000
$
250,000
$
250,000
$
129,200
$
131,760
$
130,480
$
31,000
$
31,000
$
31,000
Average
$
137,160
885.2550
New
Magnitude
of
residue
­
meat/
milk/
poultry
$
72,000
$
72,000
$
72,000
$
159,600
$
167,700
$
163,650
$
280,000
$
280,000
$
280,000
$
100,000
$
130,000
$
115,000
Average
$
157,663
885.2600
New
Magnitude
of
residue
­
potable
water,
fish,
and
irrigated
crops
$
183,000
$
237,000
$
210,000
$
168,575
$
198,075
$
183,325
$
241,400
$
300,600
$
271,000
Average
$
221,442
885.3000
New
Infectivity/
Pathogenicity
Analysis
$
250,000
$
250,000
$
250,000
Average
$
250,000
885.3050
Current
Acute
oral
toxicity/
pathogenicity
$
26,000
$
41,000
$
33,500
Average
$
33,500
885.3150
Current
Acute
pulmonary
toxicity/
pathogenicity
$
25,000
$
50,000
$
37,500
Average
$
37,500
885.3200
Current
Acute
injection
(
intravenous)
toxicity/
pathogenicity
$
25,000
$
50,000
$
37,500
Average
$
37,500
885.3200
Current
Acute
injection
(
intraperitoneal)
toxicity/
pathogenicity
$
7,000
$
18,000
$
12,500
Average
$
12,500
885.3400
Updated
Hypersensitivity
incidents
$
300
$
1,300
$
800
885.3500
Updated
Cell
Culture
$
25,000
$
35,000
$
30,000
885.3550
Updated
Acute
toxicity
62
OPPTS
Guideline
Cost
Estimate
Low
Cost
High
Cost
Average
Cost
$
3,000
$
40,000
$
21,500
885.3600
Updated
Subchronic
toxicity/
pathogenicity
$
100,000
$
200,000
$
150,000
885.3650
Updated
Reproductive/
fertility
effects
$
125,000
$
200,000
$
162,500
885.4050
Current
Avian
oral
$
12,000
$
18,000
$
15,000
Average
$
15,000
885.4100
Current
Avian
inhalation
test
$
12,000
$
20,000
$
16,000
885.4150
Updated
Wild
Mammal
Testing
$
50,000
$
80,000
$
65,000
885.4200
Current
Freshwater
Fish
testing
$
30,000
$
45,000
$
37,500
Average
$
37,500
885.4240
Current
Freshwater
aquatic
invertebrate
testing
$
30,000
$
45,000
$
37,500
Average
$
37,500
885.4280
Current
Estuarine
and
marine
animal
testing
$
32,000
$
48,000
$
40,000
Average
$
40,000
885.4280
Current
Estuarine
and
marine
invertibrate
testing
$
32,000
$
48,000
$
40,000
Average
$
40,000
885.4300
Updated
Non­
target
plant
studies
$
20,000
$
40,000
$
30,000
885.4340
Current
Non­
target
insect
testing
(
3
species)
$
21,000
$
42,000
$
31,500
Average
$
31,500
885.4380
Updated
Honey
bee
testing
$
3,500
$
5,000
$
4,250
885.4600
Updated
Avian
chronic
pathogenicity
and
reproduction
$
150,000
$
200,000
$
175,000
885.4650
Updated
Aquatic
invertebrate
range
testing
$
50,000
$
100,000
$
75,000
63
OPPTS
Guideline
Cost
Estimate
Low
Cost
High
Cost
Average
Cost
885.4700
Updated
Fish
life
cycle
studies
$
200,000
$
300,000
$
250,000
885.4750
Updated
Aquatic
ecosystem
test
$
300,000
$
400,000
$
350,000
885.5200
Updated
Terrestrial
environmental
expression
tests
$
40,000
$
80,000
$
60,000
885.5300
Updated
Freshwater
environmental
expression
tests
$
40,000
$
150,000
$
95,000
885.5400
Updated
Marine
or
estuarine
environmental
expression
tests
$
40,000
$
150,000
$
95,000
64
APPENDIX
B:
DATA
REQUIREMENT
TESTING
PROBABILITIES
BY
OPPTS
GUIDELINE
NUMBER
The
percent
of
time
tests
are
required
for
the
proposed
rule
(
the
"
proposed"
probabilities)
was
developed
by
comprehensively
analyzing
EPA
registration
data
from
1997­
2004
(
see
"
US
EPA.
2005.
Analysis
of
Data
Requirements
for
Biochemical
and
Microbial
Pesticides
from
1997­
2004").
EPA
scientists
used
their
expert
judgment
to
estimate
the
percent
of
time
the
tests
were
required
for
the
baseline,
or
the
percent
of
time
data
was
required
based
on
the
established
1984
final
rule.
The
historical
waiver
probability
estimates
were
derived
based
on
review
of
the
number
of
times
data
requirements
were
waived
for
registrations
between
1997
to
2004.
The
modified
waiver
probabilities
were
estimated
assuming
the
changes
of
the
proposed
rule
would
make
waivers
in
certain
categories
less
likely.

Biochemical
Pesticide
Data
Requirement
Testing
Probabilities
Other
Biochemicals
Plant
and
Insect
Growth
Regulators
OPPTS
Guideline
OPPTS
Guideline
Description
Base
Prob.
Incr.
Prob.
Hist.
Waiver
Prob.
Mod.
Waiver
Prob.
Base
Prob.
Incr.
Prob.
Hist.
Waiver
Prob.
Mod.
Waiver
Prob.

830.1700
Preliminary
analysis
100%
­
4%
0%
0%
100%
0%
0%
0%
830.1750
Certified
limits
100%
­
8%
0%
0%
100%
0%
0%
0%

830.1800
Enforcement
analytical
method
100%
­
15%
0%
0%
100%
0%
0%
0%

830.1900
Submittal
of
Samples
100%
­
15%
0%
0%
100%
0%
0%
0%
830.6302
Color
100%
­
4%
0%
0%
100%
0%
0%
0%
830.6303
Physical
state
100%
0%
0%
0%
100%
0%
0%
0%
830.6304
Odor
100%
­
8%
4%
4%
100%
0%
0%
0%

830.6313
Stability
to
normal
and
elevated
temperatures,
metals
and
metal
ions
100%
­
38%
4%
4%
100%
­
83%
0%
0%

830.6315
Flammability
100%
­
65%
8%
8%
100%
­
100%
17%
0%
830.6317
Storage
stability
100%
­
50%
8%
8%
100%
­
33%
17%
0%
830.6319
Miscibility
100%
­
88%
15%
15%
100%
­
100%
0%
0%
830.6320
Corrosion
characteristics
100%
­
54%
12%
12%
100%
­
33%
0%
0%
830.7000
pH
100%
­
31%
4%
4%
100%
0%
0%
0%

830.7050
UV/
Visible
light
absorption
100%
­
96%
8%
8%
100%
­
100%
0%
0%

830.7100
Viscosity
100%
­
77%
15%
15%
100%
­
100%
0%
0%

830.7200
Melting
point/
melting
range
100%
­
50%
12%
12%
100%
­
33%
0%
0%

830.7220
Boiling
point/
boiling
range
100%
­
54%
12%
12%
100%
­
83%
0%
0%

830.7300
Density/
relative
density/
bulk
density
100%
­
8%
0%
0%
100%
0%
0%
0%

830.7520
Particle
size,
fiber
length,
and
diameter
distribution
100%
­
96%
8%
8%
100%
­
100%
0%
0%

830.7840
Water
solubility
(
shake
flask
method)
100%
­
31%
12%
12%
100%
­
33%
0%
0%

830.7950
Vapor
pressure
100%
­
50%
19%
19%
100%
­
67%
0%
0%
65
Other
Biochemicals
Plant
and
Insect
Growth
Regulators
OPPTS
Guideline
OPPTS
Guideline
Description
Base
Prob.
Incr.
Prob.
Hist.
Waiver
Prob.
Mod.
Waiver
Prob.
Base
Prob.
Incr.
Prob.
Hist.
Waiver
Prob.
Mod.
Waiver
Prob.

835.1230
Sediment
and
soil
adsorption/
desorption
for
parent
and
degradates
10%
­
10%
46%
46%
10%
­
10%
83%
83%

835.1240
Soil
column
leaching
10%
­
10%
42%
42%
10%
­
10%
83%
83%

835.1410
Laboratory
volatilization
from
soil
10%
­
10%
42%
42%
10%
­
10%
83%
83%

835.2120
Hydrolysis
10%
­
10%
42%
42%
10%
­
10%
83%
83%

835.2240
Photodegradation
in
the
water
10%
­
10%
42%
42%
10%
­
10%
83%
83%

835.2410
Photodegradation
in
the
soil
10%
­
10%
42%
42%
10%
­
10%
83%
83%

835.4100
Aerobic
soil
metabolism
10%
­
10%
42%
42%
10%
­
10%
83%
83%

835.4300
Aerobic
aquatic
metabolism
10%
­
10%
42%
42%
10%
­
10%
83%
83%

850.1010
Acute
toxicity
freshwater
invertebrates
50%
­
15%
42%
42%
70%
­
20%
50%
50%

850.1025
Marine
and
Estuarine
animal
testing
0%
0%
42%
42%
0%
0%
83%
83%

850.1035
Marine
and
Estuarine
animal
testing
0%
0%
42%
42%
0%
0%
83%
83%

850.1045
Marine
and
Estuarine
animal
testing
0%
0%
42%
42%
0%
0%
83%
83%

850.1055
Marine
and
Estuarine
animal
testing
0%
0%
42%
42%
0%
0%
83%
83%

850.1075
Freshwater
fish
toxicity
50%
­
15%
42%
42%
70%
­
20%
50%
50%

850.1300
Aquatic
animal
testing
(
fish
early
life
stage
and
aquatic
invertebrates)
0%
0%
42%
42%
0%
0%
83%
83%

850.1350
Aquatic
animal
testing
(
myside
chronic
toxicity)
0%
4%
42%
42%
0%
0%
83%
83%

850.1400
Aquatic
animal
testing
(
fish
early
life
stage
­
freshwater)
0%
4%
42%
42%
0%
0%
83%
83%

850.1500
Aquatic
Field
Animal
Testing
0%
0%
42%
42%
0%
0%
83%
83%

850.1950
Aquatic
Field
Animal
Testing
0%
0%
42%
42%
0%
0%
83%
83%

850.2100
Avian
oral
toxicity
50%
­
31%
31%
31%
70%
­
53%
83%
83%
850.2200
Avian
dietary
toxicity
50%
­
35%
38%
38%
70%
­
53%
83%
83%
850.2300
Avian
Reproduction
0%
0%
42%
42%
0%
0%
83%
83%
850.2400
Wild
Mammal
Testing
0%
0%
42%
42%
0%
0%
83%
83%
850.2500
Terrestrial
Field
Testing
0%
0%
15%
15%
0%
0%
0%
0%

850.3040
Non­
target
insect
testing
(
Field
testing
for
Pollinators)
0%
0%
42%
42%
0%
0%
83%
83%

850.4100
Terrestrial
plant
toxicity,
Tier
I
(
seedling
emergence)
50%
­
42%
42%
42%
70%
­
53%
83%
83%

850.4150
Terrestrial
plant
toxicity,
Tier
I
(
vegetative
vigor)
50%
­
50%
46%
46%
70%
­
70%
100%
100%
66
Other
Biochemicals
Plant
and
Insect
Growth
Regulators
OPPTS
Guideline
OPPTS
Guideline
Description
Base
Prob.
Incr.
Prob.
Hist.
Waiver
Prob.
Mod.
Waiver
Prob.
Base
Prob.
Incr.
Prob.
Hist.
Waiver
Prob.
Mod.
Waiver
Prob.

850.4225
Seedling
emergence
0%
0%
42%
42%
0%
0%
83%
83%
850.4250
Vegetative
vigor
10%
­
10%
42%
42%
10%
­
10%
83%
83%
850.4300
Non­
target
plant
testing
0%
0%
38%
38%
0%
0%
67%
67%
850.4450
Non­
target
plant
testing
0%
0%
38%
38%
0%
0%
67%
67%
860.1100
Chemical
identity
100%
­
4%
4%
0%
100%
0%
0%
0%
860.1200
Directions
for
use
100%
­
4%
4%
0%
100%
0%
0%
0%
860.1360
Multiresidue
method
7%
­
7%
23%
23%
0%
17%
67%
67%

860.1460
Magnitude
of
Residue­
Food
handling
7%
­
7%
27%
27%
0%
17%
67%
67%

860.1480
Meat/
milk/
poultry/
eggs
7%
­
7%
27%
27%
0%
17%
67%
67%
860.1500
Crop
field
trials
7%
­
7%
27%
27%
0%
17%
67%
67%
860.1520
Processed
Food
7%
­
7%
27%
27%
0%
17%
67%
67%
860.1540
Anticipated
residues
7%
­
7%
27%
27%
0%
17%
67%
67%
860.1550
Proposed
tolerances
7%
­
7%
27%
27%
0%
17%
67%
67%

860.1560
Reasonable
grounds
in
support
of
the
petition
7%
­
7%
27%
27%
0%
17%
67%
67%

870.1100
Acute
oral
toxicity­
rat
75%
­
6%
23%
23%
75%
8%
17%
17%
870.1200
Acute
dermal
toxicity
75%
­
13%
31%
31%
75%
25%
0%
0%

870.1300
Acute
inhalation
toxicity
­
rat
75%
­
25%
42%
42%
75%
25%
0%
0%

870.2400
Primary
eye
irritation
­
rabbit
75%
­
10%
15%
15%
75%
25%
0%
0%

870.2500
Primary
dermal
irritation
75%
­
10%
15%
15%
75%
25%
0%
0%
870.2600
Dermal
sensitization
75%
­
37%
42%
42%
75%
8%
0%
0%
870.3100
90­
day
oral
(
one
species)
50%
­
50%
73%
73%
85%
­
52%
67%
67%
870.3250
90­
day
dermal
­
rat
50%
­
50%
58%
58%
0%
17%
67%
67%

870.3465
90­
day
inhalation
toxicityrat
50%
­
50%
58%
58%
85%
­
68%
50%
50%

870.3700
Prenatal
developmental
toxicity­
rat
preferably
(
oral/
dermal)
50%
­
50%
50%
50%
85%
­
35%
50%
50%

870.3800
Reproduction
and
fertility
effects
0%
4%
38%
38%
0%
0%
83%
83%

870.4100
Chronic
toxicity
­
rodent
and
nonrodent
1%
­
1%
38%
38%
0%
0%
83%
83%

870.4200
Carcinogenicity
­
two
rodent
species
­
rat
and
mouse
preferred
1%
3%
35%
35%
0%
0%
83%
83%

870.5100
Bacterial
reverse
mutation
test
85%
­
77%
50%
50%
90%
­
40%
33%
33%

870.5300
In
vitro
mammalian
cell
gene
mutation
test
85%
­
81%
42%
42%
90%
­
40%
50%
50%

870.5380
Mammaliam
spermatagonial
chromosomal
abberation
test
0%
0%
42%
42%
0%
17%
67%
67%

870.5385
In
vivo
cytogenetics
0%
0%
46%
46%
0%
33%
50%
50%

870.5395
Mammalian
erythrocyte
micronucleus
0%
4%
50%
50%
0%
17%
67%
67%

870.7200
Companion
Animal
Safety
0%
4%
0%
0%
0%
0%
0%
0%
67
Other
Biochemicals
Plant
and
Insect
Growth
Regulators
OPPTS
Guideline
OPPTS
Guideline
Description
Base
Prob.
Incr.
Prob.
Hist.
Waiver
Prob.
Mod.
Waiver
Prob.
Base
Prob.
Incr.
Prob.
Hist.
Waiver
Prob.
Mod.
Waiver
Prob.

Data
870.7800
Immunotoxicity
5%
­
1%
58%
58%
0%
50%
33%
33%

875.1000
Background
for
application
exposure
monitoring
test
guidelines
.
.
38%
.
.
.
83%

875.1100
Dermal
outdoor
exposure
.
.
38%
.
.
.
83%
875.1200
Dermal
indoor
exposure
.
.
38%
.
.
.
83%

875.1300
Inhalation
outdoor
exposure
.
.
38%
.
.
.
83%

875.1400
Inhalation
indoor
exposure
.
.
38%
.
.
.
83%
875.1500
Biological
monitoring
.
.
38%
.
.
.
83%
875.1700
Product
use
information
100%
­
100%
38%
38%
100%
­
100%
83%
83%

880.1100
Product
identity
and
composition
100%
0%
0%
0%
100%
0%
0%
0%

880.1200
Description
of
starting
materials,
production
and
formulation
process
100%
0%
0%
0%
100%
0%
0%
0%

880.1400
Discussion
of
formation
of
impurities
100%
0%
0%
0%
100%
0%
0%
0%

880.3800
Immune
response
0%
0%
42%
42%
0%
0%
83%
83%
880.4350
Non­
target
insect
testing
0%
31%
42%
42%
0%
0%
100%
100%
880.4425
Dispenser
­
water
leaching
10%
­
10%
42%
42%
10%
­
10%
83%
83%

830.7550,
830.7560,
830.7570
Partition
coefficient
(
n­
Octanol
/
Water)
100%
­
88%
15%
15%
100%
­
100%
0%
0%

860.1300­
L
Nature
of
residuelivestock
7%
­
7%
23%
23%
0%
17%
67%
67%

860.1300­
P
Nature
of
residue­
plants
7%
­
3%
23%
27%
0%
17%
67%
67%

860.1340­
L
Residue
analytical
method­
livestock
7%
­
7%
23%
23%
0%
17%
67%
67%

860.1340­
P
Residue
analytical
method­
plants
7%
­
7%
23%
23%
0%
17%
50%
50%

860.1400­
C
Magnitude
of
Residue­
Irrigated
crops
7%
­
7%
27%
27%
0%
17%
67%
67%

860.1400­
F
Magnitude
of
Residue
­
Fish
7%
­
7%
27%
27%
0%
17%
67%
67%

860.1400­
W
Magnitude
of
Residue
­
Potable
water
7%
­
7%
27%
27%
0%
17%
67%
67%

none
Hypersensitivity
incidents
2%
6%
35%
35%
0%
0%
33%
33%

waiver
Registrant
burden
to
apply
for
waivers
0%
77%
0%
0%
0%
100%
0%
0%
68
Repellents
Other
Pheromones
OPPTS
Guideline
OPPTS
Guideline
Description
Base
Prob.
Incr
Prob.
Hist.
Waiver
Prob.
Mod.
Waiver
Prob
Base
Prob.
Incr.
Prob.
Hist.
Waiver
Prob.
Mod.
Waiver
Prob.

830.1700
Preliminary
analysis
100%
0%
0%
0%
100%
0%
0%
0%
830.1750
Certified
limits
100%
0%
0%
0%
100%
0%
0%
0%

830.1800
Enforcement
analytical
method
100%
0%
0%
0%
100%
0%
0%
0%

830.1900
Submittal
of
Samples
100%
0%
0%
0%
100%
0%
0%
0%
830.6302
Color
100%
0%
0%
0%
100%
0%
0%
0%
830.6303
Physical
state
100%
0%
0%
0%
100%
0%
0%
0%
830.6304
Odor
100%
0%
0%
0%
100%
0%
0%
0%

830.6313
Stability
to
normal
and
elevated
temperatures,
metals
and
metal
ions
100%
­
13%
0%
0%
100%
­
67%
33%
33%

830.6315
Flammability
100%
­
50%
25%
25%
100%
0%
0%
0%
830.6317
Storage
stability
100%
­
50%
13%
13%
100%
0%
0%
0%
830.6319
Miscibility
100%
­
100%
38%
38%
100%
­
33%
0%
0%
830.6320
Corrosion
characteristics
100%
­
38%
13%
13%
100%
­
33%
0%
0%
830.7000
pH
100%
­
38%
0%
0%
100%
0%
0%
0%

830.7050
UV/
Visible
light
absorption
100%
­
63%
0%
0%
100%
­
100%
33%
33%

830.7100
Viscosity
100%
­
50%
13%
13%
100%
­
33%
0%
0%

830.7200
Melting
point/
melting
range
100%
­
38%
13%
13%
100%
­
67%
0%
0%

830.7220
Boiling
point/
boiling
range
100%
­
38%
0%
0%
100%
0%
0%
0%

830.7300
Density/
relative
density/
bulk
density
100%
0%
0%
0%
100%
0%
0%
0%

830.7520
Particle
size,
fiber
length,
and
diameter
distribution
100%
­
75%
0%
0%
100%
­
100%
0%
0%

830.7840
Water
solubility
(
shake
flask
method)
100%
­
25%
13%
13%
100%
0%
0%
0%

830.7950
Vapor
pressure
100%
­
25%
13%
13%
100%
­
33%
33%
33%

835.1230
Sediment
and
soil
adsorption/
desorption
for
parent
and
degradates
10%
­
10%
63%
63%
10%
­
10%
33%
0%

835.1240
Soil
column
leaching
10%
­
10%
63%
63%
10%
­
10%
33%
0%

835.1410
Laboratory
volatilization
from
soil
10%
­
10%
63%
63%
10%
­
10%
33%
0%

835.2120
Hydrolysis
10%
­
10%
63%
63%
10%
­
10%
33%
0%

835.2240
Photodegradation
in
the
water
10%
­
10%
63%
63%
10%
­
10%
33%
0%

835.2410
Photodegradation
in
the
soil
10%
­
10%
63%
63%
10%
­
10%
33%
0%

835.4100
Aerobic
soil
metabolism
10%
­
10%
63%
63%
10%
­
10%
33%
0%

835.4300
Aerobic
aquatic
metabolism
10%
­
10%
63%
63%
10%
­
10%
33%
0%

850.1010
Acute
toxicity
freshwater
invertebrates
0%
13%
50%
50%
25%
­
25%
100%
0%

850.1025
Marine
and
Estuarine
animal
testing
0%
0%
63%
63%
0%
0%
33%
0%
69
Repellents
Other
Pheromones
OPPTS
Guideline
OPPTS
Guideline
Description
Base
Prob.
Incr
Prob.
Hist.
Waiver
Prob.
Mod.
Waiver
Prob
Base
Prob.
Incr.
Prob.
Hist.
Waiver
Prob.
Mod.
Waiver
Prob.

850.1035
Marine
and
Estuarine
animal
testing
0%
0%
63%
63%
0%
0%
33%
0%

850.1045
Marine
and
Estuarine
animal
testing
0%
0%
63%
63%
0%
0%
33%
0%

850.1055
Marine
and
Estuarine
animal
testing
0%
0%
63%
63%
0%
0%
33%
0%

850.1075
Freshwater
fish
toxicity
0%
13%
63%
63%
25%
­
25%
100%
0%

850.1300
Aquatic
animal
testing
(
fish
early
life
stage
and
aquatic
invertebrates)
0%
0%
63%
63%
0%
0%
33%
0%

850.1350
Aquatic
animal
testing
(
myside
chronic
toxicity)
0%
0%
63%
63%
0%
0%
33%
0%

850.1400
Aquatic
animal
testing
(
fish
early
life
stage
­
freshwater)
0%
0%
63%
63%
0%
0%
33%
0%

850.1500
Aquatic
Field
Animal
Testing
0%
0%
63%
63%
0%
0%
33%
0%

850.1950
Aquatic
Field
Animal
Testing
0%
0%
63%
63%
0%
0%
33%
0%

850.2100
Avian
oral
toxicity
0%
25%
50%
50%
25%
­
25%
100%
0%
850.2200
Avian
dietary
toxicity
0%
13%
63%
63%
25%
­
25%
100%
0%
850.2300
Avian
Reproduction
0%
0%
63%
63%
0%
0%
33%
0%
850.2400
Wild
Mammal
Testing
0%
0%
63%
63%
0%
0%
33%
0%
850.2500
Terrestrial
Field
Testing
0%
0%
0%
0%
0%
0%
0%
0%

850.3040
Non­
target
insect
testing
(
Field
testing
for
Pollinators)
0%
0%
63%
63%
0%
0%
33%
0%

850.4100
Terrestrial
plant
toxicity,
Tier
I
(
seedling
emergence)
0%
0%
63%
63%
25%
­
25%
33%
0%

850.4150
Terrestrial
plant
toxicity,
Tier
I
(
vegetative
vigor)
0%
0%
63%
63%
25%
­
25%
33%
0%

850.4225
Seedling
emergence
0%
0%
63%
63%
0%
0%
33%
0%
850.4250
Vegetative
vigor
10%
­
10%
63%
63%
10%
­
10%
33%
0%
850.4300
Non­
target
plant
testing
0%
0%
63%
63%
0%
0%
33%
0%
850.4450
Non­
target
plant
testing
0%
0%
63%
63%
0%
0%
33%
0%
860.1100
Chemical
identity
100%
0%
0%
0%
100%
0%
0%
0%
860.1200
Directions
for
use
100%
0%
0%
0%
100%
0%
0%
0%
860.1360
Multiresidue
method
5%
­
5%
50%
0%
7%
­
7%
0%
0%

860.1460
Magnitude
of
Residue­
Food
handling
5%
­
5%
50%
0%
7%
­
7%
0%
0%

860.1480
Meat/
milk/
poultry/
eggs
5%
­
5%
50%
0%
7%
­
7%
0%
0%
860.1500
Crop
field
trials
5%
­
5%
50%
0%
7%
­
7%
0%
0%
860.1520
Processed
Food
5%
­
5%
50%
0%
7%
­
7%
0%
0%
860.1540
Anticipated
residues
5%
­
5%
50%
0%
7%
­
7%
0%
0%
860.1550
Proposed
tolerances
5%
­
5%
50%
0%
7%
­
7%
0%
0%

860.1560
Reasonable
grounds
in
support
of
the
petition
5%
­
5%
50%
0%
7%
­
7%
0%
0%

870.1100
Acute
oral
toxicity­
rat
75%
­
38%
50%
50%
75%
­
8%
33%
33%
870.1200
Acute
dermal
toxicity
75%
­
25%
50%
50%
75%
­
8%
33%
33%
70
Repellents
Other
Pheromones
OPPTS
Guideline
OPPTS
Guideline
Description
Base
Prob.
Incr
Prob.
Hist.
Waiver
Prob.
Mod.
Waiver
Prob
Base
Prob.
Incr.
Prob.
Hist.
Waiver
Prob.
Mod.
Waiver
Prob.

870.1300
Acute
inhalation
toxicity
­
rat
75%
­
25%
50%
50%
75%
­
42%
67%
67%

870.2400
Primary
eye
irritation
­
rabbit
75%
­
25%
25%
25%
75%
­
8%
33%
33%

870.2500
Primary
dermal
irritation
75%
­
25%
25%
25%
75%
­
8%
33%
33%
870.2600
Dermal
sensitization
75%
­
38%
63%
63%
75%
­
42%
67%
67%
870.3100
90­
day
oral
(
one
species)
100%
­
88%
63%
63%
50%
­
50%
33%
33%
870.3250
90­
day
dermal
­
rat
0%
25%
50%
50%
0%
0%
33%
0%

870.3465
90­
day
inhalation
toxicityrat
100%
­
100%
50%
50%
50%
­
50%
33%
33%

870.3700
Prenatal
developmental
toxicity­
rat
preferably
(
oral/
dermal)
100%
­
75%
38%
38%
50%
­
50%
33%
33%

870.3800
Reproduction
and
fertility
effects
0%
13%
50%
50%
0%
0%
33%
0%

870.4100
Chronic
toxicity
­
rodent
and
nonrodent
0%
0%
63%
63%
0%
0%
33%
0%

870.4200
Carcinogenicity
­
two
rodent
species
­
rat
and
mouse
preferred
0%
0%
63%
63%
0%
0%
33%
0%

870.5100
Bacterial
reverse
mutation
test
100%
­
63%
63%
63%
85%
­
85%
33%
33%

870.5300
In
vitro
mammalian
cell
gene
mutation
test
100%
­
75%
38%
38%
85%
­
85%
33%
33%

870.5380
Mammaliam
spermatagonial
chromosomal
abberation
test
0%
25%
50%
50%
0%
0%
33%
0%

870.5385
In
vivo
cytogenetics
0%
25%
50%
50%
0%
0%
33%
0%

870.5395
Mammalian
erythrocyte
micronucleus
0%
13%
75%
75%
0%
0%
33%
0%

870.7200
Companion
Animal
Safety
Data
0%
0%
0%
0%
0%
0%
0%
0%

870.7800
Immunotoxicity
5%
8%
75%
75%
0%
0%
33%
33%

875.1000
Background
for
application
exposure
monitoring
test
guidelines
0%
10%
63%
63%
.
.
33%
.

875.1100
Dermal
outdoor
exposure
0%
10%
63%
63%
.
.
33%
.
875.1200
Dermal
indoor
exposure
0%
10%
63%
63%
.
.
33%
.

875.1300
Inhalation
outdoor
exposure
0%
10%
63%
63%
.
.
33%
.

875.1400
Inhalation
indoor
exposure
0%
10%
63%
63%
.
.
33%
.
875.1500
Biological
monitoring
0%
10%
63%
63%
.
.
33%
.
875.1700
Product
use
information
100%
­
100%
63%
63%
100%
­
100%
33%
0%

880.1100
Product
identity
and
composition
100%
0%
0%
0%
100%
0%
0%
0%

880.1200
Description
of
starting
materials,
production
and
formulation
process
100%
0%
0%
0%
100%
0%
0%
0%

880.1400
Discussion
of
formation
of
impurities
100%
0%
0%
0%
100%
0%
0%
0%
71
Repellents
Other
Pheromones
OPPTS
Guideline
OPPTS
Guideline
Description
Base
Prob.
Incr
Prob.
Hist.
Waiver
Prob.
Mod.
Waiver
Prob
Base
Prob.
Incr.
Prob.
Hist.
Waiver
Prob.
Mod.
Waiver
Prob.

880.3800
Immune
response
0%
0%
75%
75%
0%
0%
33%
0%
880.4350
Non­
target
insect
testing
0%
0%
63%
63%
0%
0%
33%
0%
880.4425
Dispenser
­
water
leaching
10%
­
10%
63%
63%
10%
­
10%
33%
0%

830.7550,
830.7560,
830.7570
Partition
coefficient
(
n­
Octanol
/
Water)
100%
­
38%
25%
25%
100%
­
33%
33%
33%

860.1300­
L
Nature
of
residuelivestock
5%
­
5%
38%
0%
7%
­
7%
0%
0%

860.1300­
P
Nature
of
residue­
plants
5%
­
5%
25%
0%
7%
­
7%
0%
0%

860.1340­
L
Residue
analytical
method­
livestock
5%
­
5%
50%
0%
7%
­
7%
0%
0%

860.1340­
P
Residue
analytical
method­
plants
5%
­
5%
50%
0%
7%
­
7%
0%
0%

860.1400­
C
Magnitude
of
Residue­
Irrigated
crops
5%
­
5%
50%
0%
7%
­
7%
0%
0%

860.1400­
F
Magnitude
of
Residue
­
Fish
5%
­
5%
50%
0%
7%
­
7%
0%
0%

860.1400­
W
Magnitude
of
Residue
­
Potable
water
5%
­
5%
50%
0%
7%
­
7%
0%
0%

none
Hypersensitivity
incidents
2%
­
2%
38%
38%
2%
­
2%
33%
33%

waiver
Registrant
burden
to
apply
for
waivers
0%
100%
0%
0%
0%
100%
0%
0%
72
Straight
Chain
Lepidopteran
Proteins
OPPTS
Guideline
OPPTS
Guideline
Description
Base
Prob.
Incr.
Prob.
Hist.
Waiver
Prob.
Mod.
Waiver
Prob.

830.1700
Preliminary
analysis
100%
0%
0%
0%
830.1750
Certified
limits
100%
0%
0%
0%

830.1800
Enforcement
analytical
method
100%
0%
0%
0%

830.1900
Submittal
of
Samples
100%
0%
0%
0%
830.6302
Color
100%
0%
0%
0%
830.6303
Physical
state
100%
0%
0%
0%
830.6304
Odor
100%
0%
0%
0%

830.6313
Stability
to
normal
and
elevated
temperatures,
metals
and
metal
ions
100%
­
80%
0%
0%

830.6315
Flammability
100%
0%
0%
0%
830.6317
Storage
stability
100%
0%
0%
0%
830.6319
Miscibility
100%
0%
0%
0%
830.6320
Corrosion
characteristics
100%
0%
0%
0%
830.7000
pH
100%
0%
0%
0%

830.7050
UV/
Visible
light
absorption
100%
­
100%
0%
0%

830.7100
Viscosity
100%
0%
0%
0%

830.7200
Melting
point/
melting
range
100%
0%
0%
0%

830.7220
Boiling
point/
boiling
range
100%
0%
0%
0%

830.7300
Density/
relative
density/
bulk
density
100%
0%
0%
0%

830.7520
Particle
size,
fiber
length,
and
diameter
distribution
100%
­
100%
0%
0%

830.7840
Water
solubility
(
shake
flask
method)
100%
0%
0%
0%

830.7950
Vapor
pressure
100%
0%
0%
0%

835.1230
Sediment
and
soil
adsorption/
desorption
for
parent
and
degradates
0%
0%
100%
0%

835.1240
Soil
column
leaching
0%
0%
100%
0%

835.1410
Laboratory
volatilization
from
soil
0%
0%
100%
0%

835.2120
Hydrolysis
0%
0%
100%
0%

835.2240
Photodegradation
in
the
water
0%
0%
100%
0%

835.2410
Photodegradation
in
the
soil
0%
0%
100%
0%

835.4100
Aerobic
soil
metabolism
0%
0%
100%
0%

835.4300
Aerobic
aquatic
metabolism
0%
0%
100%
0%

850.1010
Acute
toxicity
freshwater
invertebrates
0%
0%
100%
0%

850.1025
Marine
and
Estuarine
animal
testing
0%
0%
100%
0%
73
Straight
Chain
Lepidopteran
Proteins
OPPTS
Guideline
OPPTS
Guideline
Description
Base
Prob.
Incr.
Prob.
Hist.
Waiver
Prob.
Mod.
Waiver
Prob.

850.1035
Marine
and
Estuarine
animal
testing
0%
0%
100%
0%

850.1045
Marine
and
Estuarine
animal
testing
0%
0%
100%
0%

850.1055
Marine
and
Estuarine
animal
testing
0%
0%
100%
0%

850.1075
Freshwater
fish
toxicity
0%
0%
100%
0%

850.1300
Aquatic
animal
testing
(
fish
early
life
stage
and
aquatic
invertebrates)
0%
0%
100%
0%

850.1350
Aquatic
animal
testing
(
myside
chronic
toxicity)
0%
0%
100%
0%

850.1400
Aquatic
animal
testing
(
fish
early
life
stage
­
freshwater)
0%
0%
100%
0%

850.1500
Aquatic
Field
Animal
Testing
0%
0%
100%
0%

850.1950
Aquatic
Field
Animal
Testing
0%
0%
100%
0%

850.2100
Avian
oral
toxicity
0%
0%
100%
0%
850.2200
Avian
dietary
toxicity
0%
0%
100%
0%
850.2300
Avian
Reproduction
0%
0%
100%
0%
850.2400
Wild
Mammal
Testing
0%
0%
100%
0%
850.2500
Terrestrial
Field
Testing
0%
0%
0%
0%

850.3040
Non­
target
insect
testing
(
Field
testing
for
Pollinators)
0%
0%
100%
0%

850.4100
Terrestrial
plant
toxicity,
Tier
I
(
seedling
emergence)
0%
0%
100%
0%

850.4150
Terrestrial
plant
toxicity,
Tier
I
(
vegetative
vigor)
0%
0%
100%
0%

850.4225
Seedling
emergence
0%
0%
100%
0%
850.4250
Vegetative
vigor
0%
0%
100%
0%
850.4300
Non­
target
plant
testing
0%
0%
100%
0%
850.4450
Non­
target
plant
testing
0%
0%
100%
0%
860.1100
Chemical
identity
100%
0%
0%
0%
860.1200
Directions
for
use
100%
0%
0%
0%
860.1360
Multiresidue
method
0%
0%
100%
100%

860.1460
Magnitude
of
Residue­
Food
handling
0%
0%
100%
100%

860.1480
Meat/
milk/
poultry/
eggs
0%
0%
100%
100%
860.1500
Crop
field
trials
0%
0%
100%
100%
860.1520
Processed
Food
0%
0%
100%
100%
860.1540
Anticipated
residues
0%
0%
100%
100%
860.1550
Proposed
tolerances
0%
0%
100%
100%

860.1560
Reasonable
grounds
in
support
of
the
petition
0%
0%
100%
100%

870.1100
Acute
oral
toxicity­
rat
0%
0%
100%
0%
870.1200
Acute
dermal
toxicity
0%
0%
100%
0%
74
Straight
Chain
Lepidopteran
Proteins
OPPTS
Guideline
OPPTS
Guideline
Description
Base
Prob.
Incr.
Prob.
Hist.
Waiver
Prob.
Mod.
Waiver
Prob.

870.1300
Acute
inhalation
toxicity
­
rat
0%
0%
100%
0%

870.2400
Primary
eye
irritation
­
rabbit
0%
0%
100%
0%

870.2500
Primary
dermal
irritation
0%
0%
100%
0%
870.2600
Dermal
sensitization
0%
0%
100%
0%
870.3100
90­
day
oral
(
one
species)
0%
0%
100%
0%
870.3250
90­
day
dermal
­
rat
0%
0%
100%
0%

870.3465
90­
day
inhalation
toxicityrat
0%
0%
100%
0%

870.3700
Prenatal
developmental
toxicity­
rat
preferably
(
oral/
dermal)
0%
0%
100%
0%

870.3800
Reproduction
and
fertility
effects
0%
0%
100%
0%

870.4100
Chronic
toxicity
­
rodent
and
nonrodent
0%
0%
100%
0%

870.4200
Carcinogenicity
­
two
rodent
species
­
rat
and
mouse
preferred
0%
0%
100%
0%

870.5100
Bacterial
reverse
mutation
test
0%
0%
100%
0%

870.5300
In
vitro
mammalian
cell
gene
mutation
test
0%
0%
100%
0%

870.5380
Mammaliam
spermatagonial
chromosomal
abberation
test
0%
0%
100%
0%

870.5385
In
vivo
cytogenetics
0%
0%
100%
0%

870.5395
Mammalian
erythrocyte
micronucleus
0%
0%
100%
0%

870.7200
Companion
Animal
Safety
Data
0%
0%
0%
0%

870.7800
Immunotoxicity
0%
0%
100%
0%

875.1000
Background
for
application
exposure
monitoring
test
guidelines
.
.
100%
.

875.1100
Dermal
outdoor
exposure
.
.
100%
.
875.1200
Dermal
indoor
exposure
.
.
100%
.

875.1300
Inhalation
outdoor
exposure
.
.
100%
.

875.1400
Inhalation
indoor
exposure
.
.
100%
.
875.1500
Biological
monitoring
.
.
100%
.
875.1700
Product
use
information
0%
0%
100%
0%

880.1100
Product
identity
and
composition
100%
0%
0%
0%

880.1200
Description
of
starting
materials,
production
and
formulation
process
100%
0%
0%
0%

880.1400
Discussion
of
formation
of
impurities
100%
0%
0%
0%
75
Straight
Chain
Lepidopteran
Proteins
OPPTS
Guideline
OPPTS
Guideline
Description
Base
Prob.
Incr.
Prob.
Hist.
Waiver
Prob.
Mod.
Waiver
Prob.

880.3800
Immune
response
0%
0%
100%
0%
880.4350
Non­
target
insect
testing
0%
0%
100%
0%
880.4425
Dispenser
­
water
leaching
0%
0%
100%
0%

830.7550,
830.7560,
830.7570
Partition
coefficient
(
n­
Octanol
/
Water)
100%
0%
0%
0%

860.1300­
L
Nature
of
residuelivestock
0%
0%
100%
100%

860.1300­
P
Nature
of
residue­
plants
0%
0%
80%
80%

860.1340­
L
Residue
analytical
method­
livestock
0%
0%
100%
100%

860.1340­
P
Residue
analytical
method­
plants
0%
0%
100%
100%

860.1400­
C
Magnitude
of
Residue­
Irrigated
crops
0%
0%
100%
100%

860.1400­
F
Magnitude
of
Residue
­
Fish
0%
0%
100%
100%

860.1400­
W
Magnitude
of
Residue
­
Potable
water
0%
0%
100%
100%

none
Hypersensitivity
incidents
0%
0%
100%
0%

waiver
Registrant
burden
to
apply
for
waivers
0%
100%
0%
0%
76
Microbial
Pesticide
Data
Requirement
Testing
Probabilities
Bacteria
Fungi
OPPTS
Guideline
OPPTS
Guideline
Description
Base
Prob.
Incr.
Prob.
Hist.
Waiver
Prob.
Mod.
Waiver
Prob.
Base
Prob.
Incr.
Prob.
Hist.
Waiver
Prob.
Mod.
Waiver
Prob.
830.6302
Color
100%
­
11%
0%
0%
100%
­
27%
0%
0%
830.6303
Physical
state
100%
0%
0%
0%
100%
­
9%
0%
0%
830.6304
Odor
100%
­
11%
0%
0%
100%
­
27%
0%
0%

830.6313
Stability
to
normal
and
elevated
temperatures,
metals
and
metal
ions
100%
­
78%
11%
11%
100%
­
73%
0%
0%
830.6317
Storage
stability
100%
­
22%
11%
11%
100%
­
36%
9%
9%
830.6319
Miscibility
100%
­
67%
11%
11%
100%
­
100%
9%
9%
830.6320
Corrosion
Characteristics
100%
­
56%
22%
22%
100%
­
82%
0%
0%
830.7000
pH
100%
0%
0%
0%
100%
­
45%
0%
0%
830.7100
Viscosity
100%
­
67%
11%
11%
100%
­
91%
0%
0%

830.7300
Density/
relative
density/
bulk
density
(
specific
gravity)
100%
­
33%
0%
0%
100%
­
36%
0%
0%

850.1950
Field
testing
for
terrestrial
wildlife
and
field
testing
for
aquatic
organisms
0%
0%
56%
56%
10%
­
10%
18%
18%

850.2500
Field
testing
for
terrestrial
wildlife
and
field
testing
for
aquatic
organisms
0%
0%
56%
56%
10%
­
10%
27%
27%
870.1100
Acute
oral
toxicity
50%
6%
44%
44%
50%
­
50%
27%
27%
870.1200
Acute
dermal
toxicity
70%
­
37%
56%
56%
70%
­
34%
9%
9%
870.1300
Acute
inhalation
toxicity
70%
­
48%
67%
67%
70%
­
52%
9%
9%
870.2400
Acute
eye
irritation
70%
­
3%
22%
22%
70%
12%
9%
9%
870.2500
Acute
dermal
irritation
70%
8%
22%
22%
70%
­
6%
27%
27%
870.4200
Carcinogenicity
0%
0%
56%
56%
0%
0%
27%
27%
870.7800
Immunotoxicity
0%
0%
56%
56%
0%
0%
27%
27%

885.0001
Primate
inferctivity
/
pathogenicity
0%
0%
56%
56%
0%
0%
36%
36%
885.1100
Product
Identity
100%
0%
0%
0%
100%
0%
0%
0%

885.1300
Discussion
of
formation
of
unintentional
ingredients
100%
0%
0%
0%
100%
0%
0%
0%
885.1400
Analysis
of
samples
100%
0%
0%
0%
100%
0%
0%
0%
885.1500
Certification
of
limits
100%
0%
0%
0%
100%
0%
0%
0%

885.2000
Background
for
Residue
analysis
of
microbial
pest
control
agents
0%
11%
11%
0%
0%
0%
18%
0%
885.2100
Chemical
Identity
0%
22%
11%
0%
0%
0%
9%
0%
885.2200
Nature
of
Residue
in
plants
0%
0%
33%
0%
0%
0%
18%
0%

885.2250
Nature
of
Residue
in
animals
0%
0%
33%
0%
0%
0%
18%
0%
885.2300
Analytical
methods­
plants
0%
0%
33%
0%
0%
0%
18%
0%

885.2350
Analytical
methodsanimals
0%
0%
33%
0%
0%
0%
18%
0%
885.2400
Storage
Stability
0%
0%
33%
0%
0%
9%
9%
0%

885.2500
Magnitude
of
residue
in
plants
0%
0%
33%
0%
0%
0%
18%
0%
77
Bacteria
Fungi
OPPTS
Guideline
OPPTS
Guideline
Description
Base
Prob.
Incr.
Prob.
Hist.
Waiver
Prob.
Mod.
Waiver
Prob.
Base
Prob.
Incr.
Prob.
Hist.
Waiver
Prob.
Mod.
Waiver
Prob.

885.2550
Magnitude
of
residue
in
meat,
milk,
poultry,
eggs
0%
0%
33%
0%
0%
0%
18%
0%

885.2600
Magnitude
of
resides
in
potable
water,
fish
and
irrigated
crops
0%
0%
33%
0%
0%
0%
18%
0%

885.3050
Acute
oral
toxicity
/
pathogenicity
90%
­
12%
22%
22%
50%
32%
18%
18%

885.3150
Acute
pulmonary
toxicity
/
pathogenicity
100%
­
44%
22%
22%
100%
­
18%
18%
18%
885.3400
Hypersensitivity
incidents
22%
0%
0%
0%
22%
­
13%
36%
36%
885.3500
Cell
culture
0%
0%
56%
56%
0%
0%
27%
27%
885.3550
Acute
toxicity
0%
0%
56%
56%
0%
0%
27%
27%

885.3600
Subchronic
toxicity
/
pathogenicity
0%
0%
56%
56%
0%
0%
27%
27%

885.3650
reproductive
fertility
effects
0%
0%
56%
56%
0%
0%
27%
27%
885.4050
Avian
oral
70%
­
26%
33%
33%
100%
­
64%
55%
55%
885.4100
Avian
injection
test
70%
­
70%
44%
44%
100%
­
82%
36%
36%
885.4150
Wild
mammal
testing
70%
­
70%
89%
89%
100%
­
82%
36%
36%
885.4200
Freshwater
fish
testing
70%
­
26%
33%
33%
100%
­
64%
55%
55%

885.4240
Freshwater
aquatic
invertebrate
testing
70%
­
26%
44%
44%
100%
­
64%
55%
55%
885.4300
Non­
target
plant
studies
70%
­
70%
78%
78%
100%
­
82%
45%
45%
885.4340
Non­
target
insect
testing
70%
­
48%
56%
56%
100%
­
73%
55%
55%
885.4380
Honey
bee
testing
70%
­
37%
44%
44%
100%
­
64%
36%
36%

885.4600
Avian
chronic
pathogenicity
and
reproduction
test.
0%
0%
56%
56%
10%
­
10%
18%
18%

885.4650
Aquatic
invertebrate
range
testing
0%
0%
56%
56%
10%
­
10%
18%
18%
885.4700
Fish
life
cycle
studies
0%
0%
56%
56%
10%
­
10%
18%
18%
885.4750
Aquatic
ecosystem
test
0%
0%
56%
56%
10%
­
10%
18%
18%

885.5200
Terrestrial
environmental
expression
tests
0%
0%
56%
56%
0%
0%
36%
36%

885.5300
Freshwater
environmental
expression
tests
0%
0%
56%
56%
0%
0%
27%
27%

885.5400
Marine
or
estuarine
environmental
expression
tests
0%
0%
0%
0%
0%
0%
0%
0%

850.2500a
Simulated
or
actual
field
tests
(
birds,
mammals)
0%
0%
56%
56%
0%
0%
18%
18%

850.2500b
Simulated
or
actual
field
test
(
aquatic
organisms)
0%
0%
56%
56%
0%
0%
18%
18%

850.2500c
Simulated
or
actual
field
tests
(
insect
predators,
parasites)
0%
0%
56%
56%
0%
0%
27%
27%

850.2500d
Simulated
or
actual
field
tests
(
plants)
0%
0%
44%
44%
0%
0%
27%
27%
885.1200a
Manufacturing
process
100%
0%
0%
0%
100%
0%
0%
0%
78
Bacteria
Fungi
OPPTS
Guideline
OPPTS
Guideline
Description
Base
Prob.
Incr.
Prob.
Hist.
Waiver
Prob.
Mod.
Waiver
Prob.
Base
Prob.
Incr.
Prob.
Hist.
Waiver
Prob.
Mod.
Waiver
Prob.

885.1200b
Deposition
of
a
sample
in
a
nationally
recognized
culture
collection
100%
0%
0%
0%
100%
0%
0%
0%
885.3000
Infectivity/
Pathogenicity
0%
0%
0%
0%
0%
0%
0%
0%

885.3200a
Acute
injection
toxicity
/
pathogenicity
intravenous
20%
58%
0%
0%
0%
36%
36%
36%

885.3200b
Acute
injection
toxicity
/
pathogenicity
intra
peritoneal
75%
14%
0%
0%
75%
­
2%
18%
18%

885.4280a
Estuarine
and
marine
animal
testing
70%
­
59%
67%
67%
100%
­
91%
55%
55%

885.4280b
Estuarine
and
marine
invertebrates
70%
­
70%
78%
78%
100%
­
100%
64%
64%

waiver
Registrant
burden
to
apply
for
waivers
0%
89%
0%
0%
0%
91%
0%
0%
79
Virus
OPPTS
Guideline
OPPTS
Guideline
Description
Base
Prob.
Incr.
Prob.
Hist.
Waiver
Prob.
Mod.
Waiver
Prob.
830.6302
Color
100%
0%
0%
0%
830.6303
Physical
state
100%
0%
0%
0%
830.6304
Odor
100%
0%
0%
0%

830.6313
Stability
to
normal
and
elevated
temperatures,
metals
and
metal
ions
100%
0%
0%
0%
830.6317
Storage
stability
100%
0%
0%
0%
830.6319
Miscibility
100%
­
100%
0%
0%
830.6320
Corrosion
Characteristics
100%
­
100%
0%
0%
830.7000
pH
100%
­
100%
0%
0%
830.7100
Viscosity
100%
­
100%
0%
0%

830.7300
Density/
relative
density/
bulk
density
(
specific
gravity)
100%
0%
0%
0%

850.1950
Field
testing
for
terrestrial
wildlife
and
field
testing
for
aquatic
organisms
0%
0%
0%
0%

850.2500
Field
testing
for
terrestrial
wildlife
and
field
testing
for
aquatic
organisms
0%
0%
0%
0%
870.1100
Acute
oral
toxicity
50%
­
50%
0%
0%
870.1200
Acute
dermal
toxicity
70%
­
70%
0%
0%
870.1300
Acute
inhalation
toxicity
70%
30%
0%
0%
870.2400
Acute
eye
irritation
70%
30%
0%
0%
870.2500
Acute
dermal
irritation
70%
­
70%
100%
100%
870.4200
Carcinogenicity
0%
0%
0%
0%
870.7800
Immunotoxicity
0%
0%
100%
100%

885.0001
Primate
inferctivity
/
pathogenicity
0%
0%
0%
0%
885.1100
Product
Identity
100%
0%
0%
0%

885.1300
Discussion
of
formation
of
unintentional
ingredients
100%
0%
0%
0%
885.1400
Analysis
of
samples
100%
0%
0%
0%
885.1500
Certification
of
limits
100%
0%
0%
0%

885.2000
Background
for
Residue
analysis
of
microbial
pest
control
agents
0%
0%
0%
0%
885.2100
Chemical
Identity
0%
0%
0%
0%
885.2200
Nature
of
Residue
in
plants
0%
0%
0%
0%

885.2250
Nature
of
Residue
in
animals
0%
0%
0%
0%
885.2300
Analytical
methods­
plants
0%
0%
0%
0%

885.2350
Analytical
methodsanimals
0%
0%
0%
0%
885.2400
Storage
Stability
0%
0%
0%
0%

885.2500
Magnitude
of
residue
in
plants
0%
0%
0%
0%

885.2550
Magnitude
of
residue
in
meat,
milk,
poultry,
eggs
0%
0%
0%
0%
80
Virus
OPPTS
Guideline
OPPTS
Guideline
Description
Base
Prob.
Incr.
Prob.
Hist.
Waiver
Prob.
Mod.
Waiver
Prob.

885.2600
Magnitude
of
resides
in
potable
water,
fish
and
irrigated
crops
0%
0%
0%
0%

885.3050
Acute
oral
toxicity
/
pathogenicity
75%
25%
0%
0%

885.3150
Acute
pulmonary
toxicity
/
pathogenicity
90%
­
90%
0%
0%
885.3400
Hypersensitivity
incidents
22%
­
22%
0%
0%
885.3500
Cell
culture
100%
­
100%
0%
0%
885.3550
Acute
toxicity
0%
0%
0%
0%

885.3600
Subchronic
toxicity
/
pathogenicity
0%
0%
0%
0%

885.3650
reproductive
fertility
effects
0%
0%
0%
0%
885.4050
Avian
oral
0%
0%
0%
0%
885.4100
Avian
injection
test
0%
0%
0%
0%
885.4150
Wild
mammal
testing
0%
0%
0%
0%
885.4200
Freshwater
fish
testing
0%
0%
0%
0%

885.4240
Freshwater
aquatic
invertebrate
testing
0%
0%
0%
0%
885.4300
Non­
target
plant
studies
0%
0%
0%
0%
885.4340
Non­
target
insect
testing
100%
­
100%
0%
0%
885.4380
Honey
bee
testing
0%
0%
0%
0%

885.4600
Avian
chronic
pathogenicity
and
reproduction
test.
0%
0%
0%
0%

885.4650
Aquatic
invertebrate
range
testing
0%
0%
0%
0%
885.4700
Fish
life
cycle
studies
0%
0%
0%
0%
885.4750
Aquatic
ecosystem
test
0%
0%
0%
0%

885.5200
Terrestrial
environmental
expression
tests
0%
0%
0%
0%

885.5300
Freshwater
environmental
expression
tests
0%
0%
0%
0%

885.5400
Marine
or
estuarine
environmental
expression
tests
0%
0%
0%
0%

850.2500a
Simulated
or
actual
field
tests
(
birds,
mammals)
0%
0%
0%
0%

850.2500b
Simulated
or
actual
field
test
(
aquatic
organisms)
0%
0%
0%
0%

850.2500c
Simulated
or
actual
field
tests
(
insect
predators,
parasites)
0%
0%
0%
0%

850.2500d
Simulated
or
actual
field
tests
(
plants)
0%
0%
0%
0%
885.1200a
Manufacturing
process
100%
0%
0%
0%

885.1200b
Deposition
of
a
sample
in
a
nationally
recognized
culture
collection
100%
0%
0%
0%
81
Virus
OPPTS
Guideline
OPPTS
Guideline
Description
Base
Prob.
Incr.
Prob.
Hist.
Waiver
Prob.
Mod.
Waiver
Prob.
885.3000
Infectivity/
Pathogenicity
0%
0%
0%
0%

885.3200a
Acute
injection
toxicity
/
pathogenicity
intravenous
75%
­
75%
0%
0%

885.3200b
Acute
injection
toxicity
/
pathogenicity
intra
peritoneal
80%
­
80%
100%
100%

885.4280a
Estuarine
and
marine
animal
testing
0%
0%
0%
0%

885.4280b
Estuarine
and
marine
invertebrates
0%
0%
0%
0%

waiver
Registrant
burden
to
apply
for
waivers
0%
100%
0%
0%