Document ID: EPA-HQ-OPP-2004-0415-0015
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2006-03-08T05:00Z

1
Attachment
A.
The
following
is
a
comparison
for
current
data
requirements
to
proposed
data
requirements
for
both
biochemical
and
microbial
pesticides.

Summary
of
Changes
Proposed
for
Biochemical
Pesticides.

Proposed
Changes
to
Study
requirements
­
Biochemicals
NR=
Not
Required
Changes
Noted
Shaded
indicates
New
Study
Current
Requirements
Proposed
Requirements
Guideline
No.
Study
Guideline
No.
Study
Pesticide
Product
Analysis
Data
Requirements
Product
Identity
and
Composition
151­
10
Product
Identity
880.1100
Product
identity
and
composition
Test
note
addition.
If
the
MP
and
EP
are
produced
by
an
integrated
formulation
system
(
non­
registered
source),
these
data
are
also
required
on
TGAI.

151­
11
Manufacturing
Process
880.1200
Description
of
starting
materials,
production
and
formulation
process
Test
note
revision.
If
the
MP
and
EP
are
produced
by
an
integrated
formulation
system
(
non­
registered
source),
these
data
are
also
required
on
TGAI.

151­
12
Discussion
of
formation
of
unintentional
ingredients
880.1400
Discussion
of
formation
of
impurities
Proposed
would
no
longer
require
discussion
on
unintentional
ingredients.
More
guidance
is
provided
for
formulation
of
impurities
in
proposed
158.340.

Analysis
of
Certified
Limits
151­
13
Analysis
of
samples
830.1700
Preliminary
Analysis
No
change
to
data
requirement,
just
a
name
change
to
the
study.

151­
15
Certification
of
Limits
830.1750
Certified
Limits
Proposed
required
for
EUP's
for
all
uses.
Currently
only
required
for
EUP's
for
food
uses
only.

151­
16
Analytical
methods
830.1800
Enforcement
analytical
method
No
change
when
required
151­
17
Physical
and
chemical
properties
For
consistency,
the
current
40
CFR
158.690
physical
chemical
characteristics
were
used
as
a
baseline.
Standard
included
[
R]
and
MP/
EP
and
TGAI
testing.
No
test
notes.
Following
Individual
data
requirements
identified:
Proposed
identifies
each
data
requirement
to
fulfill
the
category.

830.6302
Color
Current
requires
TGAI
and
MP
or
EP.
Proposed
requires
TGAI
only.

830.6303
Physical
state
Current
requires
TGAI
and
MP
or
EP.
Proposed
requires
TGAI
only
for
MP.

830.6304
Odor
Current
requires
TGAI
and
MP
or
EP.
Proposed
requires
TGAI
only.

830.6313
Stability
to
normal
and
elevated
temperatures,
metals,
and
metal
ions
Current
requires
TGAI
and
MP
or
EP.
Proposed
requires
TGAI
only.

830.6315
Flammability
Addition
of
test
note.
Proposed
is
conditionally
required
(
from
[
R]
to
[
CR])
when
product
contains
combustible
liquids.
No
longer
required
to
be
tested
on
TGAI.

830.6317
Storage
stability
Revision
in
test
substance.
Proposed
no
longer
requires
TGAI
testing.
Summary
of
Changes
Proposed
for
Biochemical
Pesticides.

Proposed
Changes
to
Study
requirements
­
Biochemicals
NR=
Not
Required
Changes
Noted
Shaded
indicates
New
Study
Current
Requirements
Proposed
Requirements
Guideline
No.
Study
Guideline
No.
Study
2
830.6319
Miscibility
Proposed
revises
test
substance
and
conditions.
Proposed
conditionally
requires
(
from
[
R]
to
[
CR])
if
the
product
is
an
emulsifiable
liquid
and
is
to
be
diluted
with
petroleum
solvents.
No
longer
requires
TGAI
testing.

830.6320
Corrosion
characteristics
Revision
in
test
substance.
Proposed
no
longer
requires
TGAI
testing.

830.7000
pH
Current
Requires
(
R).
Proposed
conditionally
requires
(
CR)
if
test
substance
is
soluble
and
dispersible
in
water.
EP
etsting
may
be
required
if
TGAI
cannot
be
isolated.

830.7050
UV/
Visible
absorption
Previously
required
for
biochemicals
under
155­
8
under
environmental
fate.
Proposed
contains
change
in
test
substance
from
PAI
to
TGAI,
and
current
CR
and
proposed
(
R)
for
all
uses.

830.7100
Viscosity
Revision
in
test
substance.
Proposed
no
longer
requires
TGAI
testing
and
data
required
only
if
the
product
is
a
liquid.

830.7200
Melting
point/
melting
range
Current
is
required
R
and
proposed
conditionally
requires
(
R)
when
technical
chemical
is
solid
at
room
temperature.
Test
substance
revision:
no
longer
MP
or
EP
testing,
just
TGAI.

830.7220
Boiling
point/
boiling
range
Current
is
required
R
and
proposed
conditionally
requires
(
R)
when
technical
chemical
is
solid
at
room
temperature.
Test
substance
revision:
no
longer
MP
or
EP
testing,
just
TGAI.

830.7300
Density/
relative
density/
bulk
density
No
Changes.
Differentiation
is
made
on
the
test
note
for
bulk
density.

830.7520
Particle
size,
fiber
length,
and
diameter
distribution
Proposed
rule
lists
this
as
a
newly
codified
data
requirement.
This
is
also
a
new
requirement
for
the
proposed
rule
for
conventional
pesticides.

830.7550
Partition
coefficient
(
noctanol
water),
shake
flask
method
Proposed
conditionally
requires
(
from
[
R]
to
[
CR])
when
organic
chemicals
unless
they
dissassociate
in
water
or
are
partially
or
completely
soluble
in
water.
Test
substance
revision:
no
longer
MP
or
EP
testing.
830.7560
Partition
coefficient
(
noctanol
water)
generator
column
method
830.7570
Partition
coefficient
(
noctanol
water),
estimation
by
liquid
chromatography
830.7840
Water
solubility
Proposed
test
substance
revision:
no
longer
MP
or
EP
testing.

830.7950
Vapor
pressure
Proposed
test
substance
revision:
no
longer
MP
or
EP
testing.
Not
required
for
salts.

Biochemical
Pesticide
Residue
Requirements
Summary
of
Changes
Proposed
for
Biochemical
Pesticides.

Proposed
Changes
to
Study
requirements
­
Biochemicals
NR=
Not
Required
Changes
Noted
Shaded
indicates
New
Study
Current
Requirements
Proposed
Requirements
Guideline
No.
Study
Guideline
No.
Study
3
153­
3
Chemical
Identity
860.1100
Chemical
identity
Revision
in
test
notes.
Proposed
no
longer
includes
application
rate
criteria
(
e.
g.
0.7
ounces
per
acre)
to
trigger
testing,
or
a
comparable
application
rate
that
would
result
in
residues
equivalent
to
0.7
ounces
per
acre.

153­
3
Directions
for
Use
860.1200
Directions
for
use
Revision
in
test
notes.
Proposed
no
longer
includes
application
rate
criteria(
e.
g.
0.7
ounces
per
acre)
to
trigger
testing,
,
or
a
comparable
application
rate
that
would
result
in
residues
equivalent
to
0.7
ounces
per
acre.
The
proposed
test
substance
is
TGAI.

153­
3
Nature
of
the
residue:
plants
860.1300
Nature
of
the
residue
in
plants
Revision
in
test
notes.
Limitations
are
placed
for
arthropod
pheromones
and
conditionally
required
for
indoor
food
uses.
Change
in
test
substances
from
PAIRA
to
TGAI.

153­
3
Nature
of
the
residue:
livestock
860.1300
Nature
of
the
residue
in
livestock
Revision
in
test
notes.
Proposed
no
longer
includes
application
rate
criteria,
e.
g.
0.7
ounces
per
acre,
to
trigger
testing.
Data
on
metabolism
in
livestock
are
conditionally
required
when
residues
occur
under
certain
conditions.
Proposed
test
substance
is
only
TGAI
and
no
longer
PAIRA
metabolite.

153­
3
Residue
analytical
method
860.1340
Residue
analytical
method­
plants/
livestock
Revision
in
test
notes.
Proposed
no
longer
includes
application
rate
criteria,
e.
g.
0.7
ounces
per
acre,
to
trigger
testing.
Required
for
greenhouse
use
resulting
in
pesticides
residues
in
food/
feed.
Proposed
not
required
for
EUPs
for
terrestrial
and
aquatic
food
uses.
Proposed
test
substance
is
no
longer
"
TGAI
and
metabolites"
but
instead
"
Residue
of
Concern".

None
860.1360
Multiresidue
method
New
requirement
for
proposed
conventionals
as
well
as
proposed
biochemicals.
Previously
part
of
the
residue
analytical
method
study.
Proposed
asking
for
residue
of
concern.

Magnitude
of
Residue
153­
3
Crop
field
trials
860.1500
Crop
field
trials
Revision
in
test
notes.
Proposed
no
longer
includes
application
rate
criteria,
e.
g.
0.7
ounces
per
acre,
to
trigger
testing.
Limitations
are
placed
for
arthropod
pheromones
and
application
methodology.
Proposed
test
substance
is
no
longer
TEP
but
instead
TGAI.

153­
3
Processed
food/
feed/
meat/
milk
/
poultry/
eggs
860.1520
Processed
food/
feed
Revision
in
test
notes.
Proposed
no
longer
includes
application
rate
criteria,
e.
g.
0.7
ounces
per
acre,
to
trigger
testing.
Proposed
test
substance
is
TGAI.

153­
3
860.1480
Meat/
milk/
poultry/
eggs
Revision
in
test
notes.
Proposed
no
longer
includes
application
rate
criteria,
e.
g.
0.7
ounces
per
acre,
to
trigger
testing.
Proposed
changes
test
substance
is
only
TGAI,
no
longer
plant
metabolite
option.
Data
on
metabolism
in
livestock
are
required
when
residues
occur
under
certain
conditions.

153­
3
Potable
water
860.1400
Potable
Water
Revision
in
test
notes.
Proposed
no
longer
includes
application
rate
criteria,
e.
g.
0.7
ounces
per
acre,
to
trigger
testing.
Revision
in
test
substance,
proposed
TGAI
not
EP.

153­
3
Fish
860.1400
Fish
Revision
in
test
notes.
Proposed
no
longer
includes
application
rate
criteria,
e.
g.
0.7
ounces
per
acre,
to
trigger
testing.
Revision
in
test
substance,
proposed
TGAI
not
EP.
Summary
of
Changes
Proposed
for
Biochemical
Pesticides.

Proposed
Changes
to
Study
requirements
­
Biochemicals
NR=
Not
Required
Changes
Noted
Shaded
indicates
New
Study
Current
Requirements
Proposed
Requirements
Guideline
No.
Study
Guideline
No.
Study
4
153­
3
Irrigated
crops
860.1400
Irrigated
Crops
Revision
in
test
notes.
Proposed
no
longer
includes
application
rate
criteria,
e.
g.
0.7
ounces
per
acre,
to
trigger
testing.
Revision
in
test
substance,
proposed
TGAI
not
EP.

153­
3
Food
handling
860.1460
Food
handling
Revision
in
test
notes.
Proposed
no
longer
includes
application
rate
criteria,
e.
g.
0.7
ounces
per
acre,
to
trigger
testing.
Revision
in
test
substance,
TGAI
instead
of
EP.

153­
3
Reduction
in
residue
860.1540
Anticipated
residues
Revision
in
test
notes.
Proposed
no
longer
includes
application
rate
criteria,
e.
g.
0.7
ounces
per
acre,
to
trigger
testing.
Proposed
change:
conditionally
required
for
indoor
use.

153­
3
Proposed
tolerance
860.1550
Proposed
tolerances
Revision
in
test
notes.
Proposed
no
longer
includes
application
rate
criteria,
e.
g.
0.7
ounces
per
acre,
to
trigger
testing.
Proposed
change:
conditionally
required
for
indoor
use.

153­
3
Reasonable
grounds
in
support
of
the
petition
860.1560
Reasonable
grounds
in
support
of
the
petition
New
test
note
indicating
only
conditionally
required
when
Tier
II
or
Tier
III
of
Human
Health
are
required.
Proposed
also
conditionally
requires
for
indoor
uses.

151­
18
Submittal
of
samples
860.1650
Submittal
of
analytical
reference
standards
Revisions
to
test
notes.
Proposed
moves
this
data
requirement
from
Product
Chemistry
to
Magnitude
of
the
Residue.
Current
conditionally
requires
for
MP,
TGAI,
and
PAI.
Proposed
only
conditionally
requires
TGAI
testing.

Toxicology
Data
Requirements
Tier
I
Most
significant
revision,
unless
otherwise
noted,
is
the
exemption
of
data
for
straight
chain
lepidopteran
pheromones
unless
applied
at
a
rate
greater
than
150
grams
active
ingredient
per
acre.

152­
10
Acute
oral
toxicity
870.1100
Acute
oral
toxicity
­
rat
Proposed
determines
level
of
volatility
(
vapor
pressure
>
104
torr).

152­
11
Acute
dermal
toxicity
870.1200
Acute
dermal
toxicity
Proposed
determines
level
of
volatility
(
vapor
pressure
>
104
torr).

152­
12
Acute
inhalation
870.1300
Acute
inhalation
toxicity
­
rat
No
significant
change.

152­
13
Primary
eye
irritation
870.2400
Primary
eye
irritation
­
rabbit
Proposed
recommends
rabbit
as
test
species.
Proposed
also
requires
both
TGAI
and
either
EP/
or
MP
testing.

152­
14
Primary
dermal
irritation
870.2500
Primary
dermal
irritation
Proposed
determines
level
of
volatility
(
vapor
pressure
>
104
torr).

152­
15
Hypersensitivity
study
870.2600
Dermal
sensitization
Replacement
for
hypersensitivity
study.
No
changes
since
this
is
an
endpoint
of
the
hypersensitivity
study
(
currently
conditionally
required,
but
required
in
the
proposed
rule).

152­
16
Hypersensitivity
incidents
None
Hypersensitivity
incidents
Proposed
is
required
instead
of
conditionally
required.
SCLPs
are
not
exempt.

152­
17
Studies
to
detect
genotoxicity
Mutagenicity
Testing
Summary
of
Changes
Proposed
for
Biochemical
Pesticides.

Proposed
Changes
to
Study
requirements
­
Biochemicals
NR=
Not
Required
Changes
Noted
Shaded
indicates
New
Study
Current
Requirements
Proposed
Requirements
Guideline
No.
Study
Guideline
No.
Study
5
870.5100
Bacterial
reverse
mutation
test
Proposed
revised
this
battery
of
studies.
The
endpoints
they
are
addressing
are
the
same.

Proposed
870.5300
includes
a
new
test
note
describing
options
for
conducting
the
study.
See
proposed
rule
for
specifics.
870.5300
In
vitro
mammalian
cell
gene
mutation
test
152­
19
Mammalian
mutagenicity
tests
870.5385
Reference
Tier
II
870.5395
Reference
Tier
II
152­
18
Immune
Response
Proposed
rule
moves
to
Tier
II
as
880.3550,
Immunotoxicity.

152­
20
90­
Day
feeding
(
1
species)
870.3100
90­
day
oral
(
one
species)
Current
rule
conditionally
requires
for
food
use,
proposed
requires
for
food
uses.
Proposed
conditionally
requires
for
nonfood
uses
when
repeated
human
exposure.

152­
21
90­
Day
dermal
(
1
species)
870.3250
90­
day
dermal
­
rat
Proposes
test
note
revision:
addition
of
criteria
­
required
if
dermal
is
primary
route
of
exposure.
Proposed
also
deleted
examples
of
swimming
pools
(
algaecide)
and
impregnated
clothing.

152­
22
90­
Day
inhalation
(
1
species)
870.3465
90­
day
inhalation
­
rat
Proposed
identifies
rat
as
preferred
test
species.

152­
23
Teratogenicity
(
one­
species)
870.3700
Prenatal
developmental
toxicity
­
rat
preferably
Proposed
revises
test
note
so
required
for
all
food
uses.
Proposed
requires
this
study
for
a
food
use
and
conditionally
requires
for
a
nonfood
use.
Proposed
identifies
rat
as
preferred
test
species.
Data
may
be
required
in
Tier
II
if
results
indicate
concern
in
Tier
I.

Special
Testing
Tier
II
152­
17
Studies
to
detect
genotoxicity
(
Part
of
the
Tier
I
battery
in
the
current
CFR)
870.5385
870.5395
In
vivo
cytogenetics:
Mammalian
spermatogonial
chromosomal
aberration
Mammalian
bone
marrow
chromosomal
aberration
Proposed
revised
this
battery
of
studies.
The
endpoints
they
are
addressing
are
no
different.
Proposed
also
revised
test
note
to
include
exposure
and
mutagenicity
criteria.

152­
23
Teratogenicity
(
Only
as
Tier
I)
870.3700
Prenatal
developmental
toxicity
(
species
different
than
Tier
I)
Proposed
conditionally
requires
Tier
II
testing
on
alternative
species
if
results
from
Tier
I
studies
indicate
concern.

152­
18
Immune
Response
As
Tier
I
data
requirement
880.3550
Immunotoxicity
The
proposed
moves
this
study
(
152­
18,
Immune
Response)
from
Tier
I
to
Tier
II.
The
proposed
also
revises
from
required
to
conditionally
required.
Proposed
revises
test
notes
indicating
conditions
required
(
e.
g.,
results
from
90­
day
studies.)

The
current
Tier
II
requirement
(
152­
24,
Immune
Response)
is
moved
to
Tier
III
in
the
proposed
rule.
The
name
of
the
data
requirement
more
accurately
reflects
the
endpoints.

None
None
875.1000
Background
for
application
exposure
monitoring
test
guidelines
Proposed
new
requirement
for
Biochemicals.
Required
for
insect
repellents
only.
Summary
of
Changes
Proposed
for
Biochemical
Pesticides.

Proposed
Changes
to
Study
requirements
­
Biochemicals
NR=
Not
Required
Changes
Noted
Shaded
indicates
New
Study
Current
Requirements
Proposed
Requirements
Guideline
No.
Study
Guideline
No.
Study
6
None
None
875.1100
Dermal
outdoor
exposure
Proposed
new
requirement
for
Biochemicals.
Required
for
insect
repellents
only.

None
None
875.1200
Dermal
indoor
exposure
Proposed
new
requirement
for
Biochemicals.
Required
for
insect
repellents
only.

None
None
875.1300
Inhalation
outdoor
exposure
Proposed
new
requirement
for
Biochemicals.
Required
for
insect
repellents
only.

None
None
875.1400
Inhalation
indoor
exposure
Proposed
new
requirement
for
Biochemicals.
Required
for
insect
repellents
only.

None
None
875.1500
Biological
monitoring
Proposed
new
requirement
for
Biochemicals.
Required
for
insect
repellents
only.

None
None
875.1700
Product
use
information
Proposed
lists
as
new
requirement.
No
test
note.
(
New
requirement
for
conventional
pesticides.)

Tier
III
152­
24
(
Tier
II
guideline
in
current
CFR
­
Tier
III
in
proposed)
Immune
response
880.3800
Immune
response
The
current
Tier
II
requirement
(
152­
24,
Immune
Response)
is
moved
to
Tier
III
in
the
proposed
rule.
The
name
of
the
data
requirement
more
accurately
reflects
the
endpoints.

Proposed
minor
test
note
revision.
Protocol
should
be
developed
after
evaluating
Tier
II
immunotoxicity
data.

152­
23
(
Tier
I
guideline
in
current
CFR
­
Tier
III
in
proposed)
Teratogenicity
(
1
species)
870.3800
Reproduction
and
fertility
effects
The
current
Tier
I
requirement
(
152­
23,
Teratogenicity)
is
addressed
in
Tier
II
as
870.3700,
Prenatal
Development
toxicity,
and
in
Tier
III
as
870.3800,
Reproduction
and
fertility
effects.

152­
17
(
Part
of
the
Tier
I
battery
in
current
CFR)
Studies
to
detect
genotoxicity
870.5380
Mammalian
spermatogonial
chromosomal
aberration
test
This
data
requirement
completes
the
battery
of
studies
to
detect
mutagenicity.
Required
based
on
lower
tier
mutagenicity
studies.

152­
26
Chronic
exposure
870.4100
Chronic
oral
­
rodent
and
nonrodent
Proposed
CR
for
all
uses
­
current
regulations
limit
to
food
uses
and
indoor
use
only.

152­
29
Oncogenicity
870.4200
Carcinogenicity
­
two
species
­
rat
and
mouse
preferred
Changed
name
to
be
scientifically
current.
Proposed
CR
for
all
uses
­
current
regulations
limit
to
food
uses
and
indoor
use
only.

None
None
870.7200
Companion
Animal
Safety
New
requirement
for
biochemical
pesticides
(
conditionally
required).
Currently,
a
requirement
for
conventional
pesticides.
Data
may
be
triggered
if
the
product's
use
will
result
in
exposure
to
domestic
animals
through,
but
not
limited
to,
direct
application
or
consumption
of
treated
food.

Non­
target
Organisms
and
Environmental
Fate
Data
Requirements:

Most
significant
revision,
unless
otherwise
noted,
is
the
exemption
of
data
for
anthropod
pheromones
unless
applied
at
a
rate
greater
than
150
grams
active
ingredient
per
acre.

Tier
I
Summary
of
Changes
Proposed
for
Biochemical
Pesticides.

Proposed
Changes
to
Study
requirements
­
Biochemicals
NR=
Not
Required
Changes
Noted
Shaded
indicates
New
Study
Current
Requirements
Proposed
Requirements
Guideline
No.
Study
Guideline
No.
Study
7
154­
6
Acute
Oral
850.2100
Avian
oral
toxicity
Proposed
expanded
requirement
to
optional
new
test
species,
redwing
blackbird.
Proposed
also
may
conditionally
require
EP
testing.
Not
required
if
highly
volatile.

154­
7
Avian
Dietary
850.2200
Avian
dietary
toxicity
Test
note
revisions.
May
be
required
if
product
is
available
to
avian
wildlife.
EP
testing
may
be
required.
Not
required
if
highly
volatile.

154­
8
Freshwater
fish
LC50
850.1075
Freshwater
fish
toxicity
Test
note
revision.
Proposed
also
conditionally
requires
EP
testing
.
Data
are
required
regardless
of
direct
application.
Not
required
if
highly
volatile.

154­
9
Freshwater
invertebrate
LC50
850.1010
Acute
toxicity
freshwater
invertebrates
Test
note
revision.
EP
testing
may
also
be
required
and
criteria
included.
Data
are
required
regardless
of
direct
application.
Not
required
if
highly
volatile.

154­
10
Non­
target
plant
studies
850.4100
Terrestrial
Plant
Toxicity
Seedling
emergence
Test
note
revision.
Proposed
specifies
uses
where
data
requirements
are
triggered.
EP
testing
may
also
be
required.
Proposed
not
required
for
greenhouse
and
indoor
use.

154­
10
Non­
target
plant
studies
850.4150
Terrestrial
Plant
Toxicity
Vegetative
vigor
Test
note
revision.
Proposed
specifies
uses
where
data
requirements
are
triggered.
EP
testing
may
also
be
required.
Proposed
not
required
for
greenhouse
and
indoor
use.

154­
11
Non­
target
insect
testing
850.3020
Honeybee
acute
contact
Proposed
contains
name
change.
Required
instead
of
conditionally
required
Tier
II
155­
4
Volatility
163­
2
(
835.1410)
Laboratory
volatilization
from
soil
Proposed
it
is
CR
for
greenhouse
use
and
NR
for
aquatic
uses.

155­
5
Dispenser
­
water
leaching
880.4425
Dispenser
­
water
leaching
Proposed
it
is
CR
for
greenhouse
use
and
NR
for
aquatic
uses.

155­
6
Adsorptiondesorption
163­
1
(
835.1230)
Sediment
and
soil
adsorption/
desorption
for
parent
and
degradates
Required
based
on
nontarget
organisms
Tier
I
testing.
Proposed
it
is
CR
for
greenhouse
use.

155­
6
Adsorption
­
desorption
163­
1
(
835.1240)
Soil
column
leaching
Required
based
on
nontarget
organisms
Tier
I
testing.
Proposed
it
is
CR
for
greenhouse
use.

155­
7
Octanol/
Water
Partition
Studies
transferred
to
product
chemistry
data
requirement
155­
8
U.
V.
absorption
155­
9
Hydrolysis
161­
1
(
835.2120)
Hydrolysis
Required
based
on
nontarget
organisms
Tier
I
testing.
Proposed
it
is
CR
for
greenhouse
use.

155­
10
Aerobic
soil
metabolism
162­
1
(
835.4100)
Aerobic
soil
metabolism
Required
based
on
nontarget
organisms
Tier
I
testing.
Proposed
it
is
CR
for
greenhouse
use.

155­
11
Aerobic
aquatic
metabolism
162­
4
(
835.4300)
Aerobic
aquatic
metabolism
Required
based
on
nontarget
organisms
Tier
I
testing.
Proposed
it
is
CR
for
greenhouse
use.

155­
12
Soil
photolysis
161­
3
(
835.2410)
Photodegradation
on
soil
Required
based
on
nontarget
organisms
Tier
I
testing.
Proposed
it
is
CR
for
greenhouse
use
and
NR
for
aquatic
uses.

155­
13
Aquatic
photolysis
161­
2
(
835.2240)
Photodegradation
in
water
Required
based
on
nontarget
organisms
Tier
I
testing.
Proposed
it
is
CR
for
greenhouse
use.
Summary
of
Changes
Proposed
for
Biochemical
Pesticides.

Proposed
Changes
to
Study
requirements
­
Biochemicals
NR=
Not
Required
Changes
Noted
Shaded
indicates
New
Study
Current
Requirements
Proposed
Requirements
Guideline
No.
Study
Guideline
No.
Study
8
154­
10
Nontarget
Plant
Testing
(
Required
as
Tier
I)
850.4225
Seedling
emergence
Test
note
revision
to
support
registration
for
known
phytotoxicants.
Required
except
for
greenhouse
and
indoor
uses.

154­
10
Nontarget
plant
testing
(
Required
as
Tier
I)
850.4250
Vegetative
vigor
Test
note
revision
to
support
registration
of
known
phytotoxicants.
Required
except
for
greenhouse
and
indoor
uses.

None
162­
2
(
835.4200)
Anerobic
soil
metabolism
Newly
codified
study
­
since
it
would
be
required
under
the
conditions
specified
in
the
test
note.

None
162­
3
(
835.4400)
Anerobic
aquatic
metabolism
Newly
codified
study
­
since
it
would
be
required
under
the
conditions
specified
in
the
test
note.

Tier
III
15­
12
Terrestrial
wildlife
testing
850.2300
Avian
Reproduction
Separated
study
as
avian
reproduction
.
Current
can
be
required
as
terrestrial
wildlife
testing.
Proposed
delineates
study.
Minor
test
note
revision­
added
criteria
to
mammalian
feed.

15­
12
Terrestrial
wildlife
testing
850.2400
Wild
mammal
acute
toxicity
Separated
as
wild
mammal
acute
toxicity.
Current
required
as
terrestrial
wildlife
testing.
Proposed
delineates
study.
Minor
test
note
revision­
added
criteria
to
mammalian
feed.

15­
12
Terrestrial
wildlife
testing
850.2500
Terrestrial
wildlife
field
testing
Proposed
conditionally
requires
using
EP.

154­
13
Aquatic
animal
testing
850.1300
850.1400
850.1500
Freshwater
fish/
invertebrate
testing
Minor
revision
in
test
note
language.
Proposed
not
limited
to
results
of
Tier
I
data.

154­
13
Aquatic
animal
testing
850.1025
850.1035
850.1045
850.1055
850.1350
850.1400
850.1500
Marine
/
Estuarine
/
fish
/
invertebrate
animal
testing
Minor
revision
in
test
note
language.
Proposed
not
limited
to
results
of
Tier
I
data.

154­
13
Aquatic
animal
testing
850.1950
Aquatic
field
fish
/
invertebrate
testing
Proposed
conditionally
requires
using
EP.
Proposed
not
limited
to
results
of
Tier
I
data.

154­
14
Non­
target
plant
studies
850.4225
850.4250
850.4300
850.4450
Nontarget
plant
No
change.
Just
more
defined
data
requirements
depending
on
the
crop
and
concern..

154­
15
Non­
target
insect
testing
850.3040
Field
testing
for
pollinators
Proposed
conditionally
requires
using
EP.
Proposed
revisions
to
test
note.
If
product
performance
data
or
mode
of
action
identifies
concerns,
then
this
testing
is
also
required.

B.
Summary
of
Changes
Proposed
to
Support
Microbial
Pesticides.

Summary
of
Changes
Proposed
for
Microbial
Pesticides
Current
Requirements
Proposed
Requirements
Diff.
From
Current
to
Proposed
Guideline
No.
Study
Guideline
No.
Study
Pesticide
Product
Analysis
Data
Requirements
Product
Identity
and
Composition
Summary
of
Changes
Proposed
for
Microbial
Pesticides
Current
Requirements
Proposed
Requirements
Diff.
From
Current
to
Proposed
Guideline
No.
Study
Guideline
No.
Study
9
151­
20
Product
Identity
885.1100
Product
Identity
Minor
test
note
revision.

151­
21
Manufacturing
Process
885.1200
Manufacturing
Process
Minor
test
note
revision.

151­
27
Submittal
of
Samples
885.1200
Deposition
of
a
sample
in
a
nationally
recognized
culture
collection
Proposed
requires
testing
on
TGAI
only,
instead
of
MP
and
TGAI,
and
EP
and
TGAI..
The
proposed
renames
this
study
to
reflect
current
practices.

151­
22
Discussion
of
formation
of
unintentional
ingredients
885.1300
Discussion
of
formulation
of
unintentional
ingredients
No
Changes
151­
23
Analysis
of
samples
885.1400
Analysis
of
Samples
Proposed
requires
[
R]
even
for
EUPs,
instead
of
conditionally
required
[
CR].
Addition
of
a
test
note
addressing
microbial
growth/
contamination.

151­
25
Certification
of
Limits
885.1500
Certification
of
Limits
No
Changes
151­
25
Analytical
methods
Proposed
no
longer
required.

151­
26
Physical
and
chemical
properties
830.6302
Color
Proposed
requires
TGAI
testing
only,
instead
of
MP
and
EP
and
TGAI
testing.

830.6303
Physical
state
Proposed
requires
TGAI
testing
only,
instead
of
MP
and
EP
and
TGAI
testing.

830.6304
Odor
Proposed
requires
TGAI
testing
only,
instead
of
MP
and
EP
and
TGAI
testing.

830.6313
Stability
to
normal
and
elevated
temperatures,
metals
and
metal
ions
Proposed
requires
TGAI
testing
only,
instead
of
MP
and
EP
and
TGAI
testing.

830.6317
Storage
stability
No
Changes
830.6319
Miscibility
Proposed
requires
MP
and
EP
testing
only,
instead
of
MP
and
EP
and
TGAI
testing.
Also
proposed
only
requires
for
emulsifiable
liquid
of
microbial
pesticides.

830.6320
Corrosion
Characteristics
Proposed
requires
MP
and
EP
testing
only,
instead
of
MP/
EP
and
TGAI
testing.
Also
proposed
only
requires
when
microbial
pesticides
are
packaged
in
metal,
plastic,
or
paper.

830.7000
pH
Proposed
requires
TGAI
testing
only,
instead
of
MP
and
EP
and
TGAI
testing.

830.7100
Viscosity
Proposed
only
requires
MP
and
EP
testing,
instead
of
TGAI
and
MP/
EP
testing.
Proposed
also
only
requires
for
liquid
forms
of
microbials.

830.7300
Density/
relative
density/
bulk
density
(
specific
gravity)
Proposed
requires
TGAI
testing
only,
instead
of
MP
and
EP
and
TGAI
testing.

151­
27
Submittal
of
Samples
No
longer
required­
Substituted
for
Deposition
of
a
sample
in
a
nationally
recognized
culture
collection
(
885.1200)
Summary
of
Changes
Proposed
for
Microbial
Pesticides
Current
Requirements
Proposed
Requirements
Diff.
From
Current
to
Proposed
Guideline
No.
Study
Guideline
No.
Study
10
Pesticide
Residue
Data
Requirements
for
all
Uses­
This
entire
category
is
more
well
defined­
though
there
are
no
additional
data
actually
required,
we
have
listed
the
guideline
numbers.
The
proposed
recommends
the
test
substance
for
each,
whereas
the
current
rule
does
not
specify
test
substance.
The
proposed
provides
a
more
explicit
test
note
as
well.

153­
4
Residue
Data
885.2000
Background
for
Residue
analysis
of
microbial
pest
control
agents
Proposed
revises
test
note.
Required
when
the
results
of
testing
indicate
the
potential
to
cause
adverse
effects
or
the
product
characterization
indicates
the
microbial
pesticide
has
a
significant
potential
to
produce
a
mammalian
toxins
and
the
use
pattern
is
such
that
they
may
be
present
on
food
or
feed
crops.
Proposed
requires
EP
testing.

153­
4
Residue
Data
885.2100
Chemical
identity
Reference
885.2000.
Proposed
requires
EP
testing.

153­
4
Residue
Data
885.2200
Nature
of
the
Residue
in
plants
Reference
885.2000.
Proposed
requires
EP
testing.

153­
4
Residue
Data
885.2250
Nature
of
the
Residue
in
animals
Reference
885.2000.
Proposed
requires
EP
testing.

153­
4
Residue
Data
885.2300
Analytical
methods
­
plants
Reference
885.2000.
Proposed
requires
TGAI
testing.

153­
4
Residue
Data
885.2350
Analytical
methods
­
animals
Reference
885.2000.
Proposed
requires
TGAI
testing.

153­
4
Residue
Data
885.2400
Storage
Stability
Reference
885.2000.
Proposed
requires
EP
testing.

153­
4
Residue
Data
885.2500
Magnitude
of
residue
in
plants
Reference
885.2000.
Proposed
requires
EP
testing.

153­
4
Residue
Data
885.2550
Magnitude
of
residues
in
meat,
milk,
poultry,
eggs
Reference
885.2000.
Proposed
requires
EP
testing.

153­
4
Residue
Data
885.2600
Magnitude
of
residues
in
potable
water,
fish,
and
irrigated
crops
Reference
885.2000.
Proposed
requires
EP
testing.

Toxicology
Data
Requirements
Tier
I
152­
30
Acute
oral
885.3050
Acute
oral
toxicity/
pathogenicity
Proposed
adds
a
test
note
addressing
the
combining
of
tests
as
long
as
the
necessary
endpoints
are
captured.
Proposed
also
requires
testing
on
TGAI
only,
instead
of
TGAI
and
MP/
EP.

152­
31
Acute
dermal
870.1200
Acute
dermal
toxicity
Proposed
does
not
require
TGAI,
instead
only
MP/
EP.
Test
note
addition
sanctioning
data
waivers
based
on
inert
data.

152­
34
Primary
dermal
870.2500
Primary
dermal
irritation
Test
note
addition
discussing
the
criteria
for
data
waivers.
Proposed
conditionally
required
instead
of
required
if
dermal
irritation
is
found
after
dosing
in
acute
dermal
toxicity
study.

152­
32
Acute
inhalation
885.3150
Acute
pulmonary
toxicity/
pathogenicity
Proposed
removes
test
note
from
study.
Proposed
only
requires
TGAI,
instead
of
MP/
EP
and
TGAI.
Summary
of
Changes
Proposed
for
Microbial
Pesticides
Current
Requirements
Proposed
Requirements
Diff.
From
Current
to
Proposed
Guideline
No.
Study
Guideline
No.
Study
11
152­
33
i.
v.,
i.
c.,
and
i.
p.
toxicity
/
infectivity
study
with
MPCAs
885.3200
Acute
injection
toxicity/
pathogenicity
(
intravenous)
Proposed
eliminates
requirement
for
viruses.
Proposed
eliminates
i.
c.
route
of
exposure
data
requirement.

Acute
injection
toxicity/
pathogenicity
(
intraperitoneal)

152.36
Hypersensitivity
Study
No
Longer
Required
152.37
Hypersensitivity
Incidents
885.3400
Hypersensitivity
incidents
Proposed
to
be
required
from
conditionally
required.
However,
the
criteria
of
time
required
has
not
been
changed.
Hypersensitivity
incidents
for
registered
products
must
be
reported
if
they
occur.

152­
39
Tissue
Culture
885.3500
Cell
culture
Proposed
requires
for
EUP's
for
all
uses
[
R],
instead
of
just
for
food
uses.

152­
40
Acute
Oral
870.1100
Acute
oral
toxicity
Proposed
requires
in
Tier
I
instead
of
Tier
II,
also
is
proposed
required
rather
than
conditionally
required.
Proposed
also
includes
test
note
revisions,
thereby
providing
option
to
combine
tests.

152­
41
Acute
inhalation
870.1300
Acute
inhalation
toxicity
Proposed
requires
instead
of
conditionally
requires
(
current
CFR),
also
sanctions
waivers
based
on
inert
data.

152­
35
Primary
eye
870.2400
Acute
eye
irritation
Proposed
adds
a
test
note
that
when
data
indicate
it
is
not
expected
to
pose
risk,
then
some
of
the
data
in
870
series
may
be
waived.

152­
38
Immune
Response
Proposed
moves
this
data
requirement
to
Tier
II.

Tier
II
None
885.3550
Acute
Toxicity
(
Acute
toxicology)
Proposed
introduces
this
as
a
data
requirement
in
Tier
II
when
significant
toxicity,
in
the
absence
of
pathogenicity
and
significant
infectivity,
is
observed
in
acute
oral,
injection,
or
pulmonary
studies
in
Tier
I.
Test
substance
to
support
MP,
EP
is
TGAI.

152­
42
Subchronic
oral
885.3600
Subchronic
toxicity/
pathogenicity
Proposed
changes
name
of
study.
Minor
test
note
revisions
to
require
data
to
evaluate
adverse
effects
due
to
microbial
contaminants
or
to
toxic
byproducts.

152­
43
Acute
I.
P.,
I.
C.
Proposed
no
longer
required.

152­
45
Primary
eye
Proposed
no
longer
required.

152­
47
Teratogenicity
Proposed
required
only
as
Tier
III
(
study
name
changed).

152­
48
Virulence
Enhancement
Proposed
no
longer
required.

152­
49
Mammalian
mutagenicity
Proposed
no
longer
required.

Tier
III
Summary
of
Changes
Proposed
for
Microbial
Pesticides
Current
Requirements
Proposed
Requirements
Diff.
From
Current
to
Proposed
Guideline
No.
Study
Guideline
No.
Study
12
152­
46
Immune
Response
870.7800
Immunotoxicity
Proposed
moves
this
from
a
Tier
I
and
II
data
requirement
to
a
Tier
III
data
requirement.
Proposed
includes
revisions
to
test
notes
addressing
viruses
affecting
the
mammalian
immune
system.
Consultation
with
the
Agency
is
encouraged
before
conducting
these
tests.

152­
47
and
152­
53
Teratogenicity
885.3650
Reproductive
fertility
effects
The
lower
Tier
II
study
is
no
longer
required
since
the
triggers
for
this
study
rely
on
toxicity
endpoints
which
are
collected
in
Tier
II
studies,
i.
e.
885.3600.
Addition
of
test
note
criteria.

152­
50
Chronic
feeding
Proposed
no
longer
requires
151­
51
Oncogenicity
870.4200
Carcinogenicity
Proposed
changed
name.
Minor
revisions
to
test
notes.

152­
52
Mutagenicity
Proposed
no
longer
requires
885.3000
Infectivity
/
pathogenicity
analysis
New
Study.
See
test
notes.

Non­
target
Organisms
and
Environmental
Fate
Data
Requirements:

Tier
I
154­
16
Avian
Oral
885.4050
Avian
oral
toxicity
Proposed
provides
minor
revisions
to
test
notes.
EUP
testing
in
no
longer
required
on
aquatic
food/
feed.

154­
17
Avian
injection
test
885.4100
Avian
inhalation
toxicity
/
pathogenicity
Proposed
replaces
this
study,
with
a
test
note
revision.
Adds
requirement
when
nature
of
toxin
indicates
potential
pathogenicity
to
birds.

154­
18
Wild
mammal
testing
885.4150
Wild
mammal
toxicity
/
pathogenicity
Proposed
provides
minor
revisions
to
test
notes.

154­
19
Freshwater
fish
testing
885.4200
Freshwater
fish
toxicity
/
pathogenicity
Proposed
provides
minor
test
note
additions.

154­
20
Freshwater
invertebrate
testing
885.4240
Freshwater
invertebrate
toxicity
/
pathogenicity
Proposed
provides
minor
test
note
additions.

154­
2
Estuarine
and
marine
animal
Testing
885.4280
Estuarine
/
Marine
fish
Testing
Proposed
provides
minor
test
note
additions.

154­
2
Estuarine
and
marine
animal
Testing
885.4280
Estuarine
and
marine
invertebrate
testing
Proposed
provides
minor
test
note
additions.

154­
2
Non­
target
plant
studies
885.4300
Nontarget
plant
testing
Proposed
adds
two
test
notes,
including
requiring
if
microbial
pesticide
is
taxonomically
related
to
known
plant
pathogen.

154­
23
Non­
target
insect
studies
885.4340
Nontarget
insect
testing
Proposed
adds
two
test
notes,
including
data
are
not
required
unless
active
microbial
ingredient
controls
the
target
insect
pest
by
a
mechanism
of
infectivity.

154­
24
Honey
bee
testing
885.4380
Honey
bee
testing
Proposed
adds
one
minor
test
note.

Tier
II
Summary
of
Changes
Proposed
for
Microbial
Pesticides
Current
Requirements
Proposed
Requirements
Diff.
From
Current
to
Proposed
Guideline
No.
Study
Guideline
No.
Study
13
155­
18
Terrestrial
environmental
expression
testing
885.5200
Terrestrial
environmental
expression
tests
Proposed
provides
minor
revisions
to
test
note
(
concerning
observed
effects
in
Tier
I
microbial
pest
control
agents).

155­
19
Freshwater
environmental
expression
tests
885.5300
Freshwater
environmental
expression
tests
No
substantive
changes.

155­
20
Marine
or
estuarine
expression
tests
885.5400
Marine
or
estuarine
environmental
expression
tests
Proposed
provides
minor
revisions
to
test
note.

Tier
III
154­
26
Avian
pathogenicity/
reproduction
test
885.4600
Avian
chronic
pathogenicity
and
reproduction
test
No
longer
dependent
on
toxicology
data.
Added
a
test
note.

154­
28
Aquatic
embryo
larvae
and
life
cycle
studies
885.4650
Aquatic
invertebrate
range
testing.
Proposed
revised
test
notes,
no
longer
including
conditions
relevant
to
quarantine
areas.

154­
27
Definitive
aquatic
animal
tests
885.4700
Fish
life
cycle
studies
Renamed
study
since
more
details
are
provided
in
more
appropriate
guidelines.

154­
29
Aquatic
ecosystem
test
885.4750
Aquatic
ecosystem
test
Proposed
revises
test
note,
which
no
longer
focuses
on
aquatic
exposure.

154­
30
Special
aquatic
tests
(
reserved)
Deleted
­
no
longer
requiring
Tier
IV­
New
Guidelines
deleted
one
testnote
for
all
studies
in
this
category
154­
25
Terrestrial
wildlife
and
aquatic
organism
testing
850.2500
Field
testing
for
terrestrial
wildlife
Proposed
provides
minor
revisions
to
test
notes,
and
adds
one
test
note
to
clarify
the
nature
in
which
these
Tier
IV
studies
are
required.
850.1950
Field
Testing
for
aquatic
organisms
154­
33
Simulate
and
actual
field
tests
(
birds,
mammals)
850.2500
Simulated
or
actual
field
tests
(
birds,
mammals)
Proposed
an
additional
test
note.

154­
34
Simulated
and
actual
field
tests
(
aquatic
organisms)
850.1950
Simulated
and
actual
field
tests
(
aquatic
organisms)
Proposed
two
additional
test
notes.

154­
35
Simulated
and
actual
field
tests
(
insect
predators,
parasites)
(
reserved)
850.1950
Simulated
and
actual
field
tests
(
insect
predators,
parasites)
Proposed
four
additional
test
notes.

154­
36
Simulated
and
actual
field
tests
(
insect
pollinators)
(
reserved)
850.2500
Simulated
and
actual
field
tests
(
insect
pollinators)
Proposed
four
additional
test
notes.

850.2500
Simulated
or
actual
field
testing
(
plants)
Proposed
four
additional
test
notes.

154­
31
Non
Target
Plant
Studies
Incorporated
into
first
study
in
Tier
III