Document ID: EPA-HQ-OPP-2005-0303-0005
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2006-06-14T04:00Z

1
UNITED
STATES
ENVIRONMENTAL
PROTECTION
AGENCY
WASHINGTON,
D.
C.
20460
OFFICE
OF
PREVENTION,
PESTICIDES
AND
TOXIC
SUBSTANCES
MEMORANDUM
SUBJECT:
Ecological
risk
assessment
for
Bacillus
mycoides
Isolate
J
(
006516),
82761­
EUP­
R,
from
Montana
Microbial
Products
for
Control
of
Cercospora
Leaf
Spot
in
Sugar
Beets
FROM:
Zig
Vaituzis,
Ph.
D.,
Senior
Microbiologist
(
signed
Mar
7,
2006)
Microbial
Pesticides
Branch
Biopesticides
and
Pollution
Prevention
Division,
7511C
TO:
Anne
Ball,
Regulatory
Action
Leader
Microbial
Pesticides
Branch
Biopesticides
and
Pollution
Prevention
Division
7511C
DP
Barcode:
D322217
Decision
No.:
360177
MRID#=
s:
46632920­
46632928
OPP
Chemical
Code:
006516
Pesticide
Name:
Bacillus
mycoides
Isolate
J
(
BmJ)
Registrant:
Montana
Microbial
Products,
1830
Ronald
Ave.,
Missoula
MT
59801
ENVIRONMENTAL
RISK
ASSESSMENT
SUMMARY
Bacillus
mycoides
isolate
J
(
BmJ)
is
an
ubiquitous
spore
forming
bacterium
commonly
found
on
plants,
in
soil,
water,
air
and
decomposing
plant
tissue.
The
low
range
estimate
for
B.
mycoides
in
soil
is
reported
to
typically
occur
at
about
105
CFU
per
gram
of
soil.
In
the
original
isolation
of
BmJ
from
sugar
beets
more
than
300
cfu
of
B.
mycoides
were
found
in
sugar
beet
leaf
washes.
B.
mycoides
isolate
J
is
not
known
to
be
pathogenic
or
toxic
to
any
environmental
animal
or
plant
species,
with
the
possible
exception
of
farmed
channel
catfish.
B.
mycoides
is
not
known
to
produce
any
toxins,
although
several
antibiotic
substances
are
produced.
The
titer
of
B.
mycoides
spores
applied
to
foliage
declines
from
106
spores/
cm2
to
between
100
and
1000
spores
/
cm2
over
a
two
week
period
(>
1,000x
reduction).
In
addition,
the
quantity
of
BmJ
applied
to
foliage,
2
7.5x1011
spores/
acre
per
application,
is
small
compared
to
the
natural
background
levels
of
B.
mycoides
reported
to
occur
in
agricultural
soils.
Considering
the
total
amount
of
naturally
occurring
B.
mycoides
in
an
acre
(
about
8
tons
of
soil),
the
naturally
occurring
background
levels
of
B.
mycoides
would
be
greater
per
unit
mount
of
soil
than
that
applied
to
foliage
in
this
EUP.
Taking
these
factors
into
consideration,
no
significant
or
irreversible
adverse
effects
on
wildlife
are
anticipated
during
the
proposed
limited
duration
and
limited
acreage
EUP.
A
reevaluation
of
environmental
risk
will
be
necessary
for
an
unlimited
commercial
use
Section
3
Registration.

I.
PROPOSED
EXPERIMENTAL
PROGRAM:

The
proposed
EUP
will
evaluate
the
efficacy
of
Bacillus
mycoides
Isolate
J
(
BmJ)
for
control
of
Cercospora
Leaf
Spot
in
Sugar
Beets
in
six
tests
at
three
locations
in
the
Red
River
Valley
of
North
Dakota,
Minnesota
and
three
locations
in
Eastern
Montana.
The
total
proposed
experimental
program
will
not
exceed
956
acres.
The
overall
objective
of
the
experimental
program
is
to
demonstrate
cost
effectiveness
of
BmJ
as
one
component
in
management
of
Cercospora
leaf
spot
in
sugar
beets
under
commercial
conditions.
The
program
will
also
evaluate
the
chances
of
finding
increased
disease
pressure
and
the
commercial
viability
of
the
product.
All
test
sites
will
be
at
least
½
mile
from
surface
water.
The
program
will
extend
from
April/
May,
through
September/
October
2006.
A
one
year
extension
may
be
requested.
Any
unused
material
will
be
disposed
of
on
site
in
accordance
with
label
directions,
or
will
be
returned
to
the
sponsor.
Methods
of
application
and
use
rates
Tests
will
typically
use
three
applications
up
to
a
maximum
of
five
applications
in
a
season.
Unless
there
is
severe
Cercospora
pressure
at
all
sites,
tests
will
use
three
of
four
applications
at
10
to
14
day
intervals
and
actual
usage
will
be
less
than
the
maximum
five
applications.
With
a
maximum
of
five
BmJ
applications
the
total
BmJ
usage
in
the
total
experimental
program
will
not
exceed
38
kg
of
TGAI
and
250
kg
of
total
formulation.
Tests
will
include
ground
spray
equipment
in
early
season
and
aerial
applications
after
the
plant
canopy
closes.
A
typical
aerial
application
will
use
about
5
gallons
of
spray
volume
per
acre.

II.
ENVIRONMENTAL
EFFECTS
A.
Non­
target
species
effects
B.
mycoides
is
an
ubiquitous
spore
forming
bacterium
commonly
found
on
plants,
in
soil,
water,
air
and
decomposing
plant
tissue.
The
low
range
estimate
for
B.
mycoides
in
soil
is
reported
to
typically
occur
at
about
105
CFU
per
gram
of
soil.
In
the
original
isolation
of
BmJ
more
than
300
CFU
of
B.
mycoides
were
isolated
from
sugar
beet
leaf
washes.
B.
mycoides
isolate
J
is
not
known
to
be
pathogenic
or
toxic
to
any
environmental
animal
or
plant
species,
with
the
possible
exception
of
farmed
channel
catfish.
B.
mycoides
is
not
known
to
produce
any
toxins,
although
several
antibiotic
substances
are
produced.
The
titer
of
B.
mycoides
spores
applied
to
foliage
declines
from
106
spores/
cm2
to
between
100
and
1000
spores
/
cm2
over
a
two
week
period
3
(>
1,000x
reduction).
In
addition,
the
quantity
of
BmJ
applied
to
foliage,
7.5x1011
spores/
acre
per
application,
is
small
compared
to
the
natural
background
levels
of
B.
mycoides
reported
to
occur
in
agricultural
soils.
Considering
the
total
amount
of
naturally
occurring
B.
mycoides
in
an
acre
(
about
8
tons
of
soil),
the
naturally
occurring
background
levels
of
B.
mycoides
would
be
greater
per
unit
mount
of
soil
than
that
applied
to
foliage
in
this
EUP.
Taking
these
factors
into
consideration,
no
significant
or
irreversible
adverse
effects
on
wildlife
are
anticipated
during
the
proposed
limited
duration
and
limited
acreage
EUP.

1.
Risk
Characterization
for
Terrestrial
Wildlife
a.
Avian
oral
and
inhalation
toxicity
The
registrant
is
requesting
a
waiver**
for
an
experimental
use
permit
for
the
following
data
requirements:

Avian
Oral,
Tier
I
(
OPPTS
885.4050)
MRID
46632920
Avian
Inhalation
Test,
Tier
I
(
OPPTS
885.4100)
MRID
46632921
Justification
B.
mycoides
occurs
naturally
in
agricultural
habitats,
and
was
isolated
from
sugar
beets
in
eastern
Montana.
Since
it
is
ubiquitous,
it
is
reasonable
to
assume
that
long­
term
exposure
of
wildlife
has
occurred.
A
literature
search
of
Biological
Abstracts
database
by
the
registrant
generated
359
citations
referencing
B.
mycoides,
none
of
which
reported
B.
mycoides
as
a
pathogen
of
birds.
One
paper
has
described
B.
mycoides
as
one
of
several
species
isolated
from
a
bacterial
plug
found
in
a
captive
parrot.
I
was
not
reported
as
a
pathogen
of
the
parrot.
An
acute
pulmonary
toxicity/
pathogenicity
study
of
BmJ
in
rats
(
MRID
46644801)
did
not
result
in
any
adverse
effects.
BmJ
will
be
applied
to
sugar
beet
fields
at
rates
that
will
produce
only
a
temporary
increase
in
the
natural
background
levels
of
B.
mycoides
found
on
sugar
beet
foliage,
and
this
amount
is
small
compared
to
the
total
level
of
B.
mycoides
found
in
soil.
This
suggests
that
the
proposed
limited
time/
acreage
EUP
is
not
likely
to
have
any
measurable
effects
on
avian
wildlife.
The
avian
testing
waiver****
justification
is
acceptable
for
this
EUP.

Avian
inhalation
testing
is
required
only
on
MPCAs
that
are
related
to
known
avian
pathogens.
Therefore
it
is
not
a
requirement
for
this
EUP.

b.
Mammalian
Wildlife
The
registrant
is
requesting
a
waiver**
for
an
experimental
use
permit
for
the
following
data
requirement:

Wild
Mammal
Testing,
Tier
I
(
OPPTS
885.4150)
MRID
No.
46632922
Justification
4
An
acute
pulmonary
toxicity/
pathogenicity
study
of
BmJ
in
rats
showed
no
adverse
effects.
Additional
toxicity
data
performed
on
rodent
species
indicate
that
there
is
no
significant
toxicity
to
rodents
from
acute
oral
testing
at
the
maximum
hazard
dose.
Literature
searches
by
the
registrant
identified
359
references
to
B.
mycoides,
none
of
which
contained
any
description
of
B.
mycoides
as
a
pathogen
in
wild
mammals.
The
proposed
experimental
program
would
be
conducted
in
intensively­
cultivated
sugar
beet
fields,
where
exposure
of
wild
animals
to
BmJ
would
be
limited.
In
light
of
the
above
toxicology
information,
risk
to
mammalian
wildlife
from
the
proposed
limited
time/
acreage
EUP
is
expected
to
be
minimal
to
nonexistent.
The
wild
mammal
waiver**
justification
is
acceptable
for
this
EUP
c.
Non­
target
Plants
The
registrant
is
requesting
a
waiver**
for
an
experimental
use
permit
for
the
following
data
requirement:

Nontarget
Plant
Studies,
Tier
I
OPPTS
885.4300
MRID
46632926
Justification
B.
mycoides
occurs
naturally
in
agricultural
habitats
and
is
a
normal
part
of
the
microbial
flora
on
plants.
Therefore
it
is
reasonable
to
assume
that
long­
term
exposure
of
plants
has
occurred.
A
literature
search
of
Biological
Abstracts
database
by
the
registrant
generated
359
citations
referencing
B.
mycoides,
none
of
which
reported
B.
mycoides
as
the
causative
agent
of
any
plant
disease
or
as
adversely
affecting
plants.
The
registrant
and
Montana
State
University
have
evaluated
BmJ
for
disease
control
in
greenhouse
and
small
plot
field
trials
of
different
plants
including
sugar
beets,
cucumber,
cantaloupe,
tomato,
potato,
and
chrysanthemum.
There
were
no
adverse
effects
resulting
from
application
of
BmJ
in
any
of
these
studies.
In
light
of
the
above
information,
risk
to
plants
from
the
proposed
limited
time/
acreage
EUP
is
expected
to
be
minimal
to
nonexistent.
The
nontarget
plant
waiver**
justification
is
acceptable
for
this
EUP.

d.
Non­
target
Invertebrate
Organisms
1.
Honey
Bees
The
registrant
is
requesting
a
waiver**
for
an
experimental
use
permit
for
the
following
data
requirement:

Honey
Bee
Testing,
Tier
I
(
OPPTS
885.4380)
MRID
46632928
Justification
B.
mycoides
occurs
naturally
in
agricultural
habitats
and
is
a
normal
part
of
the
microbial
flora
on
plants.
Therefore
it
is
reasonable
to
assume
that
long­
term
exposure
of
insects,
including
honey
bees,
has
occurred.
A
literature
search
of
Biological
Abstracts
database
by
the
registrant
generated
359
citations
referencing
B.
mycoides,
none
of
which
reported
B.
mycoides
as
a
natural
5
pathogen
of
insects
or
as
having
any
adverse
impact
on
honey
bees.
The
proposed
EUP
testing
will
occur
in
sugar
beets,
where
honey
bees
are
not
normally
present,
since
sugar
beets
do
not
flower
when
produced
as
an
annual
crop.
In
the
proposed
testing,
exposure
of
nontarget
insects
to
elevated
levels
of
B.
mycoides
resulting
from
application
of
BmJ
would
be
transitory.
A
Montana
State
University
evaluation
of
persistence
of
applied
BmJ
spores
showed
a
rapid
decline
in
spore
recovery
from
treated
sugar
beet
foliage
over
two
weeks.
Samples
taken
immediately
after
BmJ
application
showed
a
concentration
of
106
spores/
cm2
of
sugar
beet
leaf
surface,
which
declined
to
between
100
and
1000
spores/
cm2
of
leaf
surface
after
14
days.
These
data
indicate
that
the
level
of
spores
applied
plants
will
decline
rapidly.
As
a
result,
no
discernible
detrimental
effects
to
honey
bees
are
expected
from
the
proposed
limited
time/
acreage
EUP.
The
honey
bee
testing
waiver**
justification
is
acceptable
for
this
EUP.

2.
Other
insects
and
other
invertebrate
species
The
registrant
is
requesting
a
waiver**
for
an
experimental
use
permit
for
the
following
data
requirement:

Nontarget
Insect
Testing,
Tier
I
(
OPPTS
885.4340)
MRID
46632927
Justification
B.
mycoides
occurs
naturally
in
agricultural
habitats
including
plant
leaves
at
105
CFU
per
gram
of
soil
and
it
is
reasonable
to
assume
that
long­
term
exposure
of
insects
has
occurred.
A
literature
search
of
Biological
Abstracts
database
by
the
registrant
generated
359
citations
referencing
B.
mycoides,
none
of
which
reported
B.
mycoides
as
a
natural
pathogen
of
insects
or
as
having
any
adverse
impact
on
insects.
In
the
proposed
EUP
testing,
exposure
of
nontarget
insects
to
elevated
levels
of
B.
mycoides
resulting
from
application
of
BmJ
would
be
transitory.
A
Montana
State
University
evaluation
of
persistence
of
applied
BmJ
spores
showed
a
rapid
decline
in
spore
recovery
from
treated
sugar
beet
foliage
over
two
weeks.
Samples
taken
immediately
after
BmJ
application
showed
a
concentration
of
106
spores/
cm2
of
sugar
beet
leaf
surface,
which
declined
to
between
100
and
1000
spores/
cm2
of
leaf
surface
after
14
days.
As
a
result,
no
discernible
detrimental
effects
to
honey
bees
are
expected
from
the
proposed
limited
time/
acreage
EUP.
The
nontarget
insect
testing
waiver**
justification
is
acceptable
for
this
EUP.

2.
Risk
Characterization
for
Aquatic
Wildlife
a.
Fish
The
registrant
is
requesting
a
waiver**
for
an
experimental
use
permit
for
the
following
data
requirement:

Freshwater
Fish
Testing,
Tier
I
(
OPPTS
885.4200)
MRID
46632923
Justification
6
B.
mycoides
occurs
naturally
in
agricultural
habitats
and
it
is
reasonable
to
assume
that
long­
term
exposure
of
fish
has
occurred.
A
literature
search
of
Biological
Abstracts
database
by
the
registrant
generated
359
citations
referencing
B.
mycoides,
none
of
which
reported
B.
mycoides
as
a
pathogen
in
freshwater
fish
in
natural
habitats.
Goodwin,
1994,
described
isolation
of
B.
mycoides
from
infected
lesions
in
farmed
catfish,
but
the
high
density
and
stress
of
fish
in
a
catfish
pond
could
be
a
factor
in
an
opportunistic
infection.
There
is
also
minimal
risk
of
surface
water
exposure
in
the
proposed
EUP
testing.
The
proposed
test
sites
are
at
least
one­
half
mile
from
the
nearest
surface
water.
If
spray
drift
or
accidental
application
of
BmJ
over
surface
water
did
occur,
the
concentration
of
BmJ
spores
in
the
water
would
be
low.
For
example,
an
acre
dose
of
BmJ
(
7.5
x
1011
spores)
to
100
square
meters
of
surface
water
one
meter
deep
would
result
in
a
concentration
of
750
spores/
cc
of
water.
Furthermore,
the
surface
waters
in
the
proposed
EUP
areas
with
significant
fish
populations
are
large
rivers,
where
the
flow
would
dilute
any
BmJ
spore
concentrations
to
insignificant
levels.
Therefore
freshwater
fish
are
not
expected
to
be
exposed
to
increased
amounts
of
B.
mycoides
as
a
result
of
the
limited
duration
and
acreage
of
the
proposed
EUP.
The
one
report
of
B.
mycoides
isolation
from
farmed
catfish
lesions
suggests
that
for
an
unlimited
use
Section
3
Registration
fish
testing
may
be
required.
However,
the
freshwater
fish
testing
waiver**
justification
is
acceptable
for
this
limited
time
and
acreage
EUP.

b.
Aquatic
Invertebrates
The
registrant
is
requesting
a
waiver**
for
an
experimental
use
permit
for
the
following
data
requirement:

Freshwater
Aquatic
Invertebrate
Testing,
Tier
I
(
OPPTS
885.4240)
MRID
46632924
Justification
B.
mycoides
occurs
naturally
in
agricultural
habitats
and
it
is
reasonable
to
assume
that
long­
term
exposure
of
freshwater
aquatic
invertebrates
has
occurred.
A
literature
search
of
Biological
Abstracts
database
by
the
registrant
generated
359
citations
referencing
B.
mycoides,
none
of
which
reported
B.
mycoides
as
a
natural
pathogen
in
aquatic
invertebrates.
There
is
minimal
risk
of
surface
water
exposure
in
the
proposed
EUP
testing.
The
proposed
test
sites
are
at
least
onehalf
mile
from
the
nearest
surface
water.
If
spray
drift
or
accidental
application
of
BmJ
over
surface
water
did
occur,
the
concentration
of
BmJ
spores
in
the
water
would
be
low.
For
example,
an
acre
dose
of
BmJ
(
7.5
x
1011
spores)
to
100
square
meters
of
surface
water
one
meter
deep
would
result
in
a
concentration
of
750
spores/
cc
of
water.
Furthermore,
the
surface
waters
in
the
proposed
EUP
test
areas
with
significant
aquatic
invertebrate
populations
are
large
rivers,
where
the
flow
would
dilute
any
BmJ
spore
concentrations
to
insignificant
levels.
Because
B.
mycoides
occurs
naturally
in
aquatic
environments
any
additional
exposure
from
the
terrestrial
use
during
the
duration
of
the
EUP
is
extremely
small,
to
nonexistent.
Therefore
the
proposed
limited
time/
acreage
EUP
is
not
likely
to
have
any
significant
or
irreversible
effects
on
aquatic
invertebrate
populations
The
aquatic
invertebrate
testing
waiver**
justification
is
acceptable
for
this
EUP.
7
c.
Estuarine
and
Marine
Wildlife
The
registrant
is
requesting
a
waiver**
for
an
experimental
use
permit
for
the
following
data
requirement:

Estuarine
and
Marine
Animal
Testing,
Tier
I
(
OPPTS
885.4280)
MRID
No.
46632925
Justification
The
proposed
testing
sites
are
inland
and
remote
from
any
estuarine
or
marine
habitats.
The
estuarine
fish
and
shrimp
studies
are
waived
for
this
product
because
of
very
low
potential
for
exposure.

B.
Endangered
species
considerations
The
EUP
program
will
take
in
the
following
counties:
(
Montana)
:
Richland,
Treasure,
Rosebud,
Custer,
Big
Horn.
(
Minnesota)
:
Wilkin,
Polk,
Clay.
(
North
Dakota):
Pembina,
Cass,
Traill.
There
are
16
endangered/
threatened
species
of
local
concern
in
Montana
with
13
being
found
in
Richland
county.
These
include
five
plant
species:
Prairies
Aster,
Plains
cottonwood,
Nine
Anther
Dalea,
Silky
Prairie
Clover
and
Pale
Spiked
Lobelia.
Also
of
concern
are
the
Meadow
Jumping
Mouse,
Big
Eared
Bat
and
a
Great
Blue
Heron
nesting
site
(
habitat).
The
fish
species
of
concern
in
the
Yellowstone
River
and
tributaries
are
the
Blue
Sucker,
Pallid
Sturgeon,
Sickle
fin
Chub,
Sturgeon
Chub
and
he
Prairie
Paddle
fish.
These
species
do
not
occur
near
cultivated
sugar
beet
fields
and
all
test
sites
will
be
located
at
least
½
mile
from
the
habitat
where
these
species
may
occur.
In
the
counties
of
the
proposed
experimental
program
in
Minnesota
and
South
Dakota
there
are
three
endangered/
threatened
species:
The
Bald
Eagle,
the
Grey
Wolf
and
the
Western
Prairies
Fringed
Orchid.
Bald
Eagles
are
present
in
riparian
zones
in
the
proposed
trial
areas,
however,
the
trials
will
be
conducted
at
lest
½
mile
from
the
riparian
areas
bordering
the
Red
River.
Wolves
are
not
expected
to
be
present
in
the
areas
of
sugar
beet
cultivation.
The
Western
Prairies
Fringed
Orchid
occurs
in
protected
areas
of
wet
meadows
and
prairie
and
would
not
be
exposed
to
BmJ
applications
in
beet
cultivation
areas.

Therefore
the
ubiquitous
occurrence
of
B.
mycoides
in
the
environment,
a
lack
of
published
reports
of
adverse
effects
on
wildlife
by
B.
mycoides
indicate
that
exposure
to
B.
mycoides
has
no
measurable
deleterious
effects
on
endangered
terrestrial
and
aquatic
species.
Therefore
the
proposed
limited
time/
acreage
EUP
is
not
expected
to
have
a
A
may
effect
@

on
any
listed
endangered/
threatened
species.

III.
HAZARD
ASSESSMENT
B.
mycoides
is
an
ubiquitous
spore
forming
bacterium
commonly
found
on
plants,
in
soil,
water,
air
and
decomposing
plant
tissue.
The
low
range
estimate
for
B.
mycoides
in
soil
is
reported
to
typically
occur
at
about
105
CFU
per
gram
of
soil.
In
the
original
isolation
of
BmJ
from
sugar
beets
more
than
300
CFU
of
B.
mycoides
were
found
in
from
sugar
beet
leaf
washes.
B.
mycoides
isolate
J
is
not
known
to
be
pathogenic
or
toxic
to
any
environmental
animal
or
plant
species,
with
the
possible
exception
of
farmed
channel
catfish.
B.
mycoides
is
not
known
to
produce
any
toxins,
although
several
antibiotic
substances
are
produced.
The
titer
of
B.
mycoides
8
spores
applied
to
foliage
declines
from
106
spores/
cm2
to
between
100
and
1000
spores
/
cm2
over
a
two
week
period
(>
1,000x
reduction).
In
addition,
the
quantity
of
BmJ
applied
to
foliage,
7.5x1011
spores/
acre
per
application,
is
small
compared
to
the
natural
background
levels
of
B.
mycoides
reported
to
occur
in
agricultural
soils.
Considering
the
total
amount
of
naturally
occurring
B.
mycoides
in
an
acre
(
about
8
tons
of
soil),
the
naturally
occurring
background
levels
of
B.
mycoides
would
be
greater
per
unit
mount
of
soil
than
that
applied
to
foliage
in
this
EUP.
Taking
these
factors
into
consideration,
no
significant
or
irreversible
adverse
effects
on
wildlife
are
anticipated
during
the
proposed
limited
duration
and
limited
acreage
EUP.

**
APPENDIX:

Basis
for
data
wavers:
In
the
OPPTS
Harmonized
Microbial
Pesticide
Test
Guidelines
the
Agency
states:

(
3)
Principles
for
justifying
data
waivers.
(
i)
The
full
battery
of
tests
for
registration
of
MPCAs
[
and
their
toxins]
was
designed
to
give
basic
hazard
and
exposure
information
for
a
microorganism
with
totally
unknown
properties.
In
actual
practice,
an
MPCA
is
usually
well
identified,
which
may
facilitate
prediction
of
its
properties
and
behavior.
This
is
particularly
true
for
the
areas
of
human
health
and
plant
pathogenicity.
Clinical
medicine
and
agricultural
science
have
identified
most
microorganisms
associated
with
diseases.
If
an
MPCA
is
taxonomically
similar
to
a
clinically
or
agriculturally
significant
microorganism,
this
particular
area
of
concern
should
be
examined
closely,
possibly
by
requiring
additional
testing
(
as
provided
in
40
CFR
158.75)
beyond
that
specified
in
40
CFR
158.740.
Conversely,
if
the
MPCA
belongs
to
a
group
of
microorganisms
that
have
never
been
found
in
association
with
any
disease,
a
case
may
be
made
for
reducing,
or
waiving,
the
testing
requirements
for
this
area
of
concern.

(
ii)
40
CFR
part
158
contains
provisions
for
granting
waivers
for
data
requirements
in
response
to
specific
written
requests
by
applicants
(
40
CFR
158.45).
OPP
encourages
applicants
to
discuss
their
preliminary
testing
plans
with
OPP
scientists.
Waivers
of
some
testing
requirements
may
be
appropriate
for
certain
MPCAs.
This
tailoring
of
the
testing
battery
on
a
case­
by­
case
basis
relies
on
both
an
accurate
description
of
the
MPCA
and
the
existence
of
a
reliable
taxonomy
for
the
class
of
microorganism
to
which
it
belongs.
Some
microorganisms
have
been
more
closely
examined
than
others
and
have
a
larger
data
base
from
which
to
draw
conclusions.
In
addition,
certain
kinds
of
microorganisms
are
more
amenable
to
classification
than
others.
In
general,
human
and
plant
pathogenic
bacteria
have
been
best
classified
due
to
their
health
and
economic
significance.
Other
microorganisms,
particularly
protozoa
and
fungi,
might
not
be
as
well
studied
or
described,
and
it
may
be
difficult
to
predict
their
properties
reliably
from
a
taxonomic
description.
In
this
case,
it
may
be
more
difficult
to
justify
waiving
test
requirements.