Document ID: EPA-HQ-OPP-2004-0390-0003
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2004-11-05T05:00Z

BIOPESTICIDES
REGISTRATION
ACTION
DOCUMENT
Chondrostereum
purpureum
strain
PFC
2139
(
PC
Code
081308)

U.
S.
Environmental
Protection
Agency
Office
of
Pesticide
Programs
Biopesticides
and
Pollution
Prevention
Division
Microbial
Pesticides
Branch
Chondrostereum
purpureum
strain
PFC
2139
September
20,
2004
Biopesticides
Registration
Action
Document
ii
TABLE
OF
CONTENTS
I.
EXECUTIVE
SUMMARY
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2
II.
OVERVIEW
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A.
Product
Overview
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B.
Use
Profile
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C.
Estimated
Usage
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D.
Data
Requirements
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E.
Regulatory
History
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6
III.
SCIENCE
ASSESSMENT
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6
A.
Physical
and
Chemical
Properties
Assessment
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B.
Human
Health
Assessment
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1.
Toxicology
and
Pathogenicity
Assessment
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a.
Acute
Toxicity
and
Pathogenicity
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b.
Subchronic
Toxicity
and
Chronic
Toxicity
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15
c.
Effects
on
the
Immune
and
Endocrine
Systems
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15
2.
Dose
Response
Assessment
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15
3.
Dietary
Exposure
and
Risk
Characterization
(
includes
drinking
water)
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16
4.
Occupational,
Residential,
School
and
Day
Care
Exposure
and
Risk
Characterization
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16
5.
Drinking
Water
Exposure
and
Risk
Characterization
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17
6.
Acute
and
Chronic
Dietary
Risks
for
Sensitive
Subpopulations
Particularly
Infants
and
Children
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17
7.
Aggregate
Exposure
from
Multiple
Routes
Including
Dermal,
Oral,
and
Inhalation
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17
8.
Cumulative
Effects
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18
C.
Environmental
Assessment
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18
1.
Environmental
Fate
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18
2.
Ecological
Toxicity
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21
D.
Efficacy
Data
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27
1.
Effectiveness
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27
2.
Phytotoxicity
to
target
plants
(
including
different
cultivars),
or
to
target
plant
products
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31
3.
Economics
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32
4.
Sustainability
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32
5.
Conclusions
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34
Chondrostereum
purpureum
strain
PFC
2139
September
20,
2004
Biopesticides
Registration
Action
Document
iii
IV.
RISK
MANAGEMENT
AND
RE/
REGISTRATION
DECISION
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34
A.
Determination
of
Eligibility
of
Registration
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34
B.
Regulatory
Position
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34
C.
Labeling
Rational
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35
V.
PUBLIC
INTEREST
FINDING
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36
VI.
ACTIONS
REQUIRED
BY
REGISTRANTS
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36
A.
Precautionary
Labeling
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36
B.
Environmental
Hazards
Labeling
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37
1.
End­
Use
Product
Environmental
Hazards
Labeling
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37
2.
Manufacturing­
Use
Product
Environmental
Hazards
Labeling
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37
3.
Application
Rate
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37
C.
Other
Labeling
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38
VII.
BIBLIOGRAPHY
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38
Chondrostereum
purpureum
strain
PFC
2139
September
20,
2004
Biopesticides
Registration
Action
Document
1
BIOPESTICIDE
REGISTRATION
ACTION
DOCUMENT
TEAM
Office
of
Pesticide
Programs:

Biopesticides
and
Pollution
Prevention
Division
Microbial
Pesticide
Branch**

Joel
Gagliardi,
Ph.
D.
Microbial
Ecologist
John
Kough,
Ph.
D.
Senior
Scientist
Susanne
Cerrelli
Regulatory
Action
Leader
Jim
Downing
Environmental
Protection
Specialist
Dennis
Szuhay
Branch
Chief
Brian
Steinwand
Joint
Review
Coordinator,
EPA
**
We
wish
to
acknowledge
the
staff
of
Health
Canada,
Pest
Management
Regulatory
Agency
who
reviewed
Chondrostereum
purpureum
strain
PFC
2139
data
jointly
with
the
United
States
(
U.
S.)
Environmental
Protection
Agency
(
EPA)
in
the
Pesticides
Joint
Review
Program.

Pest
Management
Regulatory
Agency
(
PMRA)

Brian
Belliveau,
Ph.
D.
Head,
Biopesticides
Evaluation
Section
Health
Evaluation
Division
Denis
Rochon
Senior
Evaluation
Officer
Biopesticides
Evaluation
Section
Health
Evaluation
Division
Deborah
Ashby
Evaluation
Officer
Biopesticides
Evaluation
Section
Health
Evaluation
Division
Andrew
Russell
Senior
Evaluation
Officer,
Herbicides
Section
Efficacy
and
Sustainability
Assessment
Division,
PMRA
Mark
Brohm
Joint
Review
Coordinator,
PMRA
Chondrostereum
purpureum
strain
PFC
2139
September
20,
2004
Biopesticides
Registration
Action
Document
2
I.
EXECUTIVE
SUMMARY
Cp­
PFC
2139,
and
its
end­
use
product,
Chontrol
Paste,
were
developed
by
MycoLogic,
Inc.
These
biopesticide
products
were
reviewed
jointly
by
Health
Canada's
Pest
Management
Regulatory
Agency
(
PMRA)
and
the
United
States
(
U.
S.)
Environmental
Protection
Agency
(
EPA)
within
the
North
American
Free
Trade
Agreement's
Technical
Working
Group
(
NAFTA
TWG)
on
Pesticides
Joint
Review
Program.

Chontrol
Paste
is
a
vegetation
management
product
intended
to
inhibit
sprouting
and
regrowth
in
cut
stumps
of
certain
deciduous
tree
species
in
rights­
of­
way
and
forests.
Chondrostereum
purpureum
strain
PFC
2139,
is
a
naturally­
occurring
fungus.
The
only
reported
ecological
niche
for
C.
purpureum
is
in
the
xylem
of
living
or
recently
dead
broadleaf
trees
and
shrubs.
It
is
not
host
specific,
having
a
wide
host
range
as
a
wound
pathogen.
Despite
its
broad
host
range,
its
impact
is
limited.
C.
purpureum
can
invade
only
through
fresh
wounds
in
the
xylem,
and
it
is
a
weak
pathogen,
affecting
only
compromised
trees.
Healthy
trees
repel
fungal
infection
with
antifungal
metabolites
(
phytoalexins)
and
by
compartmentalizing
infected
tissues.
Because
the
fungus
can
survive
as
a
saprophyte,
there
is
little
selection
pressure
toward
greater
virulence
or
host
specialization.
Chondrostereum
purpureum
is
disseminated
through
the
production
of
numerous
short­
lived
basidiospores
from
fertile
fruiting
bodies
(
basidiocarps).
A
storage
stability
study
showed
a
significant
loss
in
potency
over
90
days.
Therefore
the
applicant
must
continue
to
ensure
that
the
product
release
standards
include
a
titre
of
at
least
106
Colony
Forming
Units
(
CFU)/
kg,
and
change
the
product
label
to
reflect
the
limited
storage
stability
of
this
product.

Toxicology
and
Pathogenicity
The
acute
toxicity
and
infectivity
studies
submitted
in
support
of
registration
of
Cp­
PFC
2139
and
Chontrol
Paste
were
reviewed.
The
data
set
included
acceptable
acute
oral
toxicity,
acute
dermal
toxicity
and
acute
eye
irritation
studies,
with
a
supplemental
acute
pulmonary
toxicity/
infectivity
study.
The
acute
dermal
toxicity
data
also
contained
sufficient
information
to
make
a
decision
on
primary
dermal
irritation.
No
overt
signs
of
toxicity
were
noted
when
C.
purpureum
strain
PFC
2139
was
administered
to
rats
and
rabbits
via
the
oral
and
dermal
routes
of
exposure.
Chondrostereum
purpureum
strain
PFC
2139
appeared
to
be
slightly
toxic
in
the
rat
via
the
intratracheal
route,
however,
additional
data
and
information
are
required
to
properly
interpret
these
results
as
clinical
signs
(
e.
g.,
loss
of
body
weight)
were
noted
in
both
treated
and
control
rats,
and
no
explanation
was
provided
for
the
single
mortality
noted
on
day
2.
In
rabbits,
C.
purpureum
strain
PFC
2139
was
slightly
irritating
when
applied
dermally,
and
was
minimally
irritating
when
instilled
in
the
eye.
Furthermore,
C.
purpureum
has
not
been
reported
to
produce
any
mammalian
toxins
and
is
not
known
to
infect
mammalian
tissues
or
grow
at
or
near
normal
body
temperature
(
37

C).
Chondrostereum
purpureum
strain
PFC
2139
September
20,
2004
Biopesticides
Registration
Action
Document
3
When
handled
according
to
the
label
instructions,
the
potential
for
applicator
exposure
is
limited
to
the
dermal
route.
On
the
basis
of
its
biological
properties,
lack
of
toxicity
and
pathogenicity,
and
the
proposed
use
pattern
for
Chontrol
Paste,
it
is
recommended
that
the
label
include
standard
personal
protective
equipment
including
gloves,
long­
sleeved
shirt,
long
pants,
shoes
and
socks
when
handling
this
product.
For
the
TGAI,
it
is
recommended
that
the
label
include
these
standard
personal
protective
equipment
(
PPE)
plus
a
dust/
mist
filtering
respirator
(
MSH/
NIOSH
approval
number
prefix
TC­
21C)
or
a
NIOSH
approved
respirator
with
any
N
 
95,
R­
95,
P­
95
or
HE
filter
for
biological
products
to
prevent
inhalation
exposure
as
a
general
precaution
for
all
microbial
products
and
since
the
acute
pulmonary
toxicity/
infectivity
study
was
considered
to
be
supplemental.

Environmental
assessment
Several
published
papers
and
field
trials
describing
the
environmental
effects
of
Chondrostereum
purpureum
strain
PFC
2139
following
its
use
as
a
biological
herbicide
were
submitted
for
review.
These
included
analyses
of
genetic
variation
in
native
populations
of
C.
purpureum,
environmental
fate
field
trials,
environmental
toxicology
studies
and
environmental
fate
models
which
predicted
sporulation
and
spore
dispersal
patterns.

The
active
ingredient,
C.
purpureum,
is
a
ubiquitous
organism
with
a
continuously
distributed
population
across
North
America.
Although
single
restriction
site
polymorphisms
(
nuclear
types)
showed
a
polarized
distribution
across
North
America,
both
types
do
occur
on
either
coast,
and
there
is
a
convergence
of
types
in
central
populations
suggesting
that
gene
flow
is
continuous
across
the
continent.
Where
the
entire
genome
was
examined,
variation
was
shown
to
be
greater
within
populations
than
between
geographic
locations
or
host
types.
A
field
study
measuring
genetic
similarity
between
introduced
C.
purpureum
biocontrol
strains
and
field­
collected
C.
purpureum
isolates
gathered
before
and
after
a
field
release
showed
no
increase
in
similarity
to
biocontrol
strains
between
pre­
and
post­
release
field
isolates.
Taken
together,
these
studies
indicate
that
the
application
of
a
single
biocontrol
strain
across
North
America
will
have
a
minimal
effect
on
the
genetic
diversity
of
resident
C.
purpureum
populations.

Chondrostereum
purpureum
is
ubiquitous
in
the
forest
ecosystem,
so
non­
target
organisms
are
naturally
exposed
to
a
large
number
of
spores.
However,
an
extensive
literature
search
found
no
reports
of
direct
adverse
effects
on
birds,
wild
mammals,
fish,
arthropods,
non­
arthropod
invertebrates
or
aquatic
plants.
As
expected,
many
articles
identified
C.
purpureum
as
the
causative
agent
of
silverleaf
disease
in
terrestrial
plants.
Acute
mammalian
toxicity
testing
showed
that
C.
purpureum
strain
PFC
2139
is
not
toxic
when
administered
orally.
It
may
be
slightly
toxic
but
shows
no
signs
of
being
pathogenic
or
infective
on
pulmonary
exposure.
Chontrol
Paste
is
a
slight
dermal
irritant,
but
it
is
practically
non­
irritating
to
the
eyes.
Because
C.
purpureum
does
not
grow
at
35

C
and
is
killed
by
sustained
incubation
at
37

C,
it
is
unlikely
to
be
a
pathogen
of
mammals
or
birds.
Based
on
the
lack
of
reported
adverse
effects,
the
lack
of
significant
toxicity
or
infectivity
in
acute
mammalian
toxicity/
infectivity
studies,
and
the
inability
of
C.
purpureum
to
grow
at
high
temperatures,
adverse
effects
due
to
the
use
of
C.
purpureum
strain
PFC
2139
are
not
expected
to
birds,
wild
mammals,
fish,
arthropods,
non­
arthropod
invertebrates
and
aquatic
plants.
Chondrostereum
purpureum
strain
PFC
2139
September
20,
2004
Biopesticides
Registration
Action
Document
4
The
risk
to
non­
target
terrestrial
plants
was
addressed
in
several
studies.
Chontrol
Paste
is
to
be
applied
as
a
mycelial
paste
to
stumps
immediately
after
cutting
the
tree
near
the
ground.
The
products
paste
formulation
is
expected
to
minimize
the
exposure
of
non­
target
plants
to
C.
purpureum
mycelia.
This
was
demonstrated
in
a
research
article
showing
no
recovery
of
C.
purpureum
strain
PFC
2139
from
areas
adjacent
to
a
site
treated
with
mycelial
paste.
Wounded
nontarget
trees
are
more
likely
to
be
infected
by
spores
from
fruiting
bodies
growing
on
untreated
stumps.
Environmental
models
of
sporulation
and
spore
dispersal
in
C.
purpureum
suggest
that
the
additional
spore
density
contributed
by
the
deployment
of
biological
control
strains
is
equal
in
magnitude
to,
or
less
than,
the
density
of
naturally
occurring
spores
from
resident
C.
purpureum
populations.
The
incremental
increase
in
spore
density
due
to
biocontrol
operations
is
not
expected
to
increase
the
likelihood
of
non­
target
effects.
Tree
wounding,
not
spore
load,
appears
to
be
the
primary
determinant
of
infection,
and
the
overall
health
of
a
tree
appears
to
determine
the
extent
of
disease
progression.
Although
buffer
zones
have
been
considered
for
C.
purpureum
biocontrol
products,
empirical
studies
indicate
that
no
buffer
zone
is
required
since
non­
target
healthy
trees
are
at
negligible
risk,
while
wounded
trees
are
equally
vulnerable
to
resident
populations
of
C.
purpureum
as
they
are
to
introduced
biocontrol
strains.

II.
OVERVIEW
A.
Product
Overview
Microbial
Pesticide
Name:
Chondrostereum
purpureum
strain
PFC
2139
Trade
Name(
s):
Chontrol
Paste
(
end­
use
product)
CP­
PFC
2139
(
manufacturing
use
product)

PC
Code:
081308
ATCC/
Culture
Collection
Number:
60854
Basic
Manufacturer:
MycoLogic
Inc.
Department
of
Biology
University
of
Victoria
P.
O.
Box
3020
Victoria,
BC,
Canada
V8W
3N5
US
Agent:
Dr.
Michael
Braverman,
IR­
4
Project
IR­
4
Headquarters
Center
for
Speciality
Crop
Pest
Management
Rutgers,
The
State
University
of
New
Jersey
681
US
#
1
South
North
Brunswick,
NJ
08902­
3390
Chondrostereum
purpureum
strain
PFC
2139
September
20,
2004
Biopesticides
Registration
Action
Document
5
B.
Use
Profile
Type
of
Pesticide:
Microbial
Herbicide
Use
Sites:
Chontrol
Paste
is
a
vegetation
management
product
intended
to
inhibit
sprouting
and
regrowth
from
cut
stumps
of
certain
deciduous
(
hardwood)
tree
species
in
rights­
of­
way,
and
in
forest
vegetation
management.

Target
Pests
for
Active
Ingredient:
hardwood
trees
and
shrubs
including
red
alder,
sitka
alder,
speckled
alder
and
trembling
aspen.

Formulation
Types:
The
Manufacturing
Use
Product
is
a
wettable
powder
and
the
End­
Use
Product
is
a
paste.

Method
and
Rates
of
Application:
Topically
applied
as
a
mycelial
paste
formula
to
entire
surface
of
freshly
cut
stump
during
summer
or
autumn
forestry
cutting
operations.
About
5.0
mL
of
Chontrol
Paste
per
each
cut
surface
of
a
2
to
6
cm
stump
(
approximately
5,000
CFU
per
stump)
is
applied
with
a
squeeze
bottle.

C.
Estimated
Usage
This
is
the
first
conditional
registration
of
the
active
ingredient,
so
estimated
usage
data
are
not
available.

D.
Data
Requirements
The
submissions
to
comply
with
Agency
data
requirements
for
granting
this
conditional
registration
under
Section
3(
c)(
7)(
C)
of
the
Federal
Insecticide,
Fungicide
and
Rodenticide
Act
(
FIFRA)
have
been
reviewed
by
the
Biopesticides
and
Pollution
Prevention
Division
(
BPPD).
For
Chondrostereum
purpureum
strain
PFC
2139,
the
product
identity
and
analysis
data,
as
well
as
the
data
and
information
submitted
for
acute
mammalian
toxicology
and
ecological
effects,
are
sufficient
to
allow
the
proposed
use
patterns
with
only
one
exception.
Based
on
evaluations
of
submitted
data,
as
discussed
in
this
document,
the
Agency
foresees
no
unreasonable
adverse
effects
to
human
health
and
the
environment
from
the
use
of
Chondrostereum
purpureum
strain
PFC
2139,
as
long
as
it
is
used
as
labeled.

Conditions
of
registration
for
this
new
active
ingredient
are
replacement
of
the
acute
pulmonary
infectivity
and
toxicity
study
or
alternatively
submission
of
an
acute
intraperitoneal
injection
infectivity
study
to
satisfactorily
address
the
toxicity
and
infectivity
potential
of
Chondrostereum
purpureum
strain
PFC
2139.
If
more
extensive
use
patterns
are
sought
including
treatment
of
other
sites
or
crops,
additional
information
and
data
will
be
required
on
a
case­
by­
case
basis.
Chondrostereum
purpureum
strain
PFC
2139
September
20,
2004
Biopesticides
Registration
Action
Document
6
E.
Regulatory
History
In
1990,
the
Netherlands
had
an
application
for
a
forestry
product
based
on
Chondrostereum
purpureum.
However
that
product
was
never
registered
in
the
Netherlands
because
the
applicant
withdrew
the
application.

In
Canada,
C.
purpureum
has
been
investigated
as
a
mycoherbicide
since
1990.
Myco­
Tech
Paste,
a
stump
re­
sprouting
inhibitor
containing
C.
purpureum
strain
HQ­
1
has
been
registered
in
Canada
since
2002
(
Reg.
No.
27020).

On
April
15,
1999
a
formal
request
was
submitted
to
EPA
by
Mycologic
Incorporated
for
a
Joint
Review
of
the
Chondrostereum
purpureum
strain
PFC
2139
submission
with
both
the
PMRA
in
Canada
and
the
Environmental
Protection
Agency
in
the
United
States.
Subsequently,
Mycologic
Incorporated
submitted
an
application
to
EPA
on
August
2,
2001
for
registration
of
Chontrol
Paste
and
Cp­
PFC
2139
Manufacturing
Use
Product
which
contain
the
active
ingredient
Chondrostereum
purpureum
strain
PFC
2139.

III.
SCIENCE
ASSESSMENT
A.
Physical
and
Chemical
Properties
Assessment
Identity
of
the
active
micro­
organism
Active
Micro­
organism
Chondrostereum
purpureum
strain
PFC
2139
Function
Mycoherbicide
Binomial
name:
Chondrostereum
purpureum
(
Pers.
ex.
Fr.)
Pouzar
isolate
PFC
2139
Taxonomic
designation:

Kingdom:
Phylum:
Subphylum:
Class:
Order:
Family:
Genus:
Species:
Strain:
Eumycota
Dikaryomycota
Basidiomycotina
Holobasidiomycetes
Aphyllophorales
Corticiaceae
Chondrostereum
purpureum
PFC
2139
Patent
Status
Information:
Canadian:
None.
U.
S.
patent:
5,587,158
"
Biological
control
for
weed
trees"
Wall,
R.
et
al.
1996.

Nominal
purity
of
active
105
to
107
CFU/
kg
Chondrostereum
purpureum
strain
PFC
2139
September
20,
2004
Biopesticides
Registration
Action
Document
7
1.
Product
Identity
The
EPA
has
classified
Chondrostereum
purpureum
strain
PFC
2139
as
a
microbial
pesticide.
Chontrol
Paste
and
Cp­
PFC
2139
are
products
that
contain
living
Chondrostereum
purpureum
strain
PFC
2139
as
the
active
ingredient.
Chontrol
Paste
is
a
formulated
product
containing
living
mycelia
of
the
fungus
Chondrostereum
purpureum
isolate
PFC
2139
for
application
to
freshly
cut
stumps
of
weedy
deciduous
brush
species
in
rightsof
way
and
forest
vegetation
management
situations.
The
product
is
designed
to
deliver
a
dose
of
105
to
107
CFU/
kg
with
an
average
of
5
grams
of
Chontrol
Paste
applied
per
stump
(
approximately
5,000
CFU
per
stump),
depending
on
the
stump
diameter.
Use
of
the
product
is
proposed
across
Canada
and
the
United
States
for
the
inhibition
of
resprouting
and
regrowth
from
cut
stumps
of
deciduous
trees
and
shrubs,
including
red
alder,
sitka
alder,
speckled
alder
and
trembling
aspen.
The
use
of
C.
purpureum
as
a
vegetation
management
tool
was
first
reported
in
the
Netherlands,
where
a
mycelial
inoculum
was
applied
to
freshly
cut
stumps
of
Prunus
serotina
(
black
cherry),
an
introduced
tree
species
in
the
Netherlands.
In
Canada,
C.
purpureum
has
been
investigated
as
a
mycoherbicide
since
1990.
Myco­
Tech
Paste,
a
stump
resprouting
inhibitor
containing
C.
purpureum
strain
HQ­
1
has
been
registered
in
Canada
since
2002.

2.
Mode
of
Action
Chondrostereum
purpureum
strain
PFC
2139
was
isolated
from
a
canker
on
a
red
alder
(
Alnus
rubra
Bong)
on
Vancouver
Island
near
Duncan,
British
Columbia
in
1994.
The
canker
developed
as
a
result
of
inoculation
in
July
1993
with
strain
PFC2090,
originally
isolated
from
an
apple
tree
(
Malus
spp.)
in
Saanicton,
British
Columbia
in
1989.
It
is
naturally
occurring
and
has
not
been
genetically
modified.

Chondrostereum
purpureum
is
a
cosmopolitan
species
that
is
widely
distributed
in
temperate
regions
of
the
northern
and
southern
hemispheres.
It
is
ubiquitous
in
Canada
and
common
in
the
United
States
south
to
Virginia
in
the
east
and
to
northern
California
in
the
west.
The
only
reported
ecological
niche
for
C.
purpureum
is
in
the
xylem
of
living
or
recently
dead
broadleaf
trees
and
shrubs.
It
is
a
white­
rot
fungus,
and
the
causative
agent
of
silverleaf,
an
important
disease
in
fruit
trees.
Silverleaf
symptoms
arise
when
the
C.
purpureum
mycelia
occlude
xylem
vessels,
blocking
the
transfer
of
sap
to
the
leaves.
The
leaf
epidermis
detaches
from
the
palisadic
parenchyma,
and
the
air
gap
between
these
layers
gives
the
leaves
a
"
silvery"
appearance.
Pectinase
enzymes
released
by
C.
purpureum
may
also
contribute
to
silverleaf
symptoms.
Chondrostereum
purpureum
also
produces
sterpurane
sesquiterpenes.
Several
sterpuranes,
such
as
sterpuric
acid,
sterepolide
and
dihydrosterepolide,
have
been
reported
to
induce
toxicity
symptoms
such
as
leaf
yellowing.
Chondrostereum
purpureum
is
not
host
specific,
having
a
wide
host
range
as
a
wound
pathogen
of
deciduous
trees
and
shrubs.
In
spite
of
its
broad
host
range,
its
impact
is
limited.
It
can
invade
only
through
fresh
wounds
in
the
xylem,
and
it
is
a
weak
pathogen
causing
a
mild
sapstreak
in
many
infected
trees
and
killing
only
severely
compromised
trees.
Healthy
trees
repel
fungal
infection
with
antifungal
metabolites
(
phytoalexins)
and
by
compartmentalizing
infected
tissues.
Because
the
fungus
can
survive
as
a
saprophyte
there
is
little
selection
pressure
toward
greater
virulence
or
host
specialization.

Chondrostereum
purpureum
is
disseminated
through
the
production
of
numerous
short­
lived
basidiospores
from
fertile
fruiting
bodies
(
basidiocarps).
Sporophores
develop
when
numerous
terminal
dikaryotic
cells
enlarge
to
form
basidia
which,
after
fusion
of
haploid
nuclei,
produce
four
basidiospores.
This
usually
occurs
between
one
and
three
years
after
infection
is
initiated.
If
the
host
tree
is
killed,
C.
purpureum
may
continue
to
fructify
on
dead
tissues
until
replaced
by
more
competitive
saprophytic
species.
Sporophores
only
Chondrostereum
purpureum
strain
PFC
2139
September
20,
2004
Biopesticides
Registration
Action
Document
8
produce
spores
after
immersion
in
free
water,
or
if
grown
on
a
substrate
with
greater
than
75%
moisture
content.
This
makes
rainfall
the
most
important
environmental
factor
governing
spore
release.
Released
spores
are
sensitive
to
sunlight
and
dry
conditions,
and
are
considered
unlikely
to
survive
for
more
than
five
hours.
This
suggests
that
long
distance
translocation
of
spores
is
unlikely.
Infection
of
a
new
host
begins
with
the
deposition
of
basidiospores
on
fresh
stem
wounds
or
the
surface
of
cut
stumps.
In
fresh
wounds
the
small
basidiospores
are
drawn
by
capillary
action
up
to
20
mm
into
the
xylem
tissues
where
they
are
free
from
competition
with
other
fungi.
Sporulation
is
reported
as
optimum
below
20

C
with
wet
conditions
(>
90
%
relative
humidity),
and
spores
optimally
germinate
within
24
hours
at
17.5
­
28

C
and
>
75%
water
content,
though
a
high
germination
rate
was
also
notes
at
5

C.
Spore­
producing
basidiocarps
are
reported
to
retain
viability
despite
12
months
of
dehydration
and
can
resume
basidiospore
production
within
6­
8
hours
of
rehydration.

Chondrostereum
purpureum
is
heterothallic.
This
type
of
sexual
reproduction
promotes
outbreeding
because
successful
conjugation
occurs
between
two
genetically
distinct,
but
compatible,
mycelia.
Sexual
compatibility
is
controlled
by
specific
genetic
determinants
known
as
mating
factors,
controlled
by
many
alleles,
occurring
at
two
loci.
Compatibility
testing
among
North
American
isolates
and
between
North
American
isolates
and
those
from
Sweden
and
Norway
indicates
that
C.
purpureum
maintains
a
highly
diverse
population
of
mating
type
alleles.
Consequently,
a
significant
level
of
genetic
variation
within
the
species
is
expected.
In
studies
where
isolates
from
across
North
America
were
tested,
considerable
heterogeneity
was
indeed
observed
using
randomly
amplified
polymorphic
DNA
(
RAPD)
analysis
and
sequence
characterized
amplified
region
(
SCAR)
analysis.
Genetic
diversity
appears
to
be
continuously
distributed
across
North
America.
Although
single
restriction
site
polymorphisms
(
nuclear
types)
showed
a
polarized
distribution
across
the
continent,
both
types
do
occur
on
either
coast
and
there
is
a
convergence
of
types
in
central
populations
suggesting
that
gene
flow
is
continuous
across
the
continent.
Where
the
entire
genome
was
examined,
variation
was
shown
to
be
greater
within
populations
than
between
geographic
locations
or
host
types.

Physical
and
chemical
properties
of
technical
and
end­
use
product(
s)

Technical
Product:
Cp­
PFC
2139
Property
Result
Physical
state
white
powder
Odor
slightly
mushroom
Specific
gravity
1.5­
2.5
g/
mL
Viscosity
NA
Corrosion
character
not
reported
(
non­
oxidizing
or
reducing)

Wettability
water
dispersable
pH
(
in
solution)
5­
8
as
a
10%
suspension
Moisture
content
~
17%
Chondrostereum
purpureum
strain
PFC
2139
September
20,
2004
Biopesticides
Registration
Action
Document
9
End­
Use
Product:
Chontrol
Paste
Property
Result
Physical
state
white
paste
Odor
slightly
corn
oil
and
mushroom
Specific
gravity
1.0
­
2.0
g/
mL
Viscosity
paste
or
thick
gel
(
similar
to
mayonnaise)

Corrosion
character
not
reported
(
non
oxidizing
or
reducing)

Wettability
water
dispersable
pH
(
in
solution)
5­
8
as
a
10%
dispersion
Moisture
content
~
40%

Product
chemistry
data
which
support
the
registration
of
Chondrostereum
purpureum
strain
PFC
2139
as
a
Microbial
Pest
Control
Agent
(
MPCA)
are
summarized
below.

OPPTS
GUIDELINE
Number
STUDY
RESULT
MRID#

885.11
Product
Identity
and
Disclosure
of
Ingredients
Acceptable
45493302
885.12
Manufacturing
Process
Acceptable
45493302
885.13
Formation
of
Unintentional
Ingredients
Acceptable
45493302
885.14
Analysis
of
Samples
Acceptable
45493302
885.15
Certification
of
Limits
Acceptable
45493302
830.6302
830.6303
830.6304
830.7000
885.7300
Product
Chemistry
Acceptable
45493302
B.
Human
Health
Assessment
There
is
a
reasonable
certainty
that
no
harm
will
result
from
exposure
to
Chondrostereum
purpureum
strain
PFC
2139.
This
includes
all
anticipated
dietary
exposures
and
all
other
exposures
for
which
there
is
reliable
information.
Chondrostereum
purpureum
strain
PFC
2139
September
20,
2004
Biopesticides
Registration
Action
Document
10
1.
Toxicology
and
Pathogenicity
Assessment
a.
Acute
Toxicity
and
Pathogenicity
Acute
oral
toxicity/
pathogenicity
The
toxicity
of
C.
purpureum
strain
PFC
2139
was
assessed
by
acute
oral
challenge
in
rats.
In
a
preliminary
test
for
lethality,
fasted
male
and
female
rats
(
3/
sex)
were
challenged
by
oral
gavage
with
a
suspension
of
C.
purpureum
strain
PFC
2139
mixed
in
sterile
water
at
a
dose
of
5
g/
kg
body
weight
(
bw).
No
signs
of
toxicity
were
noted
during
the
4­
day
observation
period.
In
the
definitive
study,
male
and
female
rats
(
5/
sex)
were
fasted
overnight
and
treated
by
gavage
with
a
single
5g
dose
per
kg
bw
(
containing
1.2x106
CFU)
of
undiluted
suspension
of
C.
purpureum
strain
PFC
2139
(
equivalent
to
2.5
 
4.4
×
105
CFU/
animal).
The
animals
were
observed
at
least
daily
for
14
days,
and
weighed
weekly.
A
gross
necropsy
was
performed
on
all
animals
at
study
termination.
All
rats
survived
the14­
day
period
and
all
animals,
male
and
female,
gained
weight
steadily
during
the
study.
No
signs
of
toxicity
were
noted
for
any
animal
and
there
were
no
gross
lesions
noted
at
necropsy.
Chondrostereum
purpureum
strain
PFC
2139
was
of
low
toxicity,
as
the
combined
LD
50
was
greater
than
5g/
kg
bw
(
1.2
×
106
CFU/
kg
bw).
The
formulant
ingredients
were
not
assessed,
though
a
review
of
potential
toxicity
(
MSDS
sheets
corresponding
to
the
CAS
numbers
provided)
and
levels
of
the
formulants
in
the
EP
indicates
that,
at
most,
mild
irritation
would
result
from
ingestion.

The
oral
exposure
studies
did
not
investigate
the
infective
potential
of
the
microbial
pest
control
agent
(
MPCA).
The
test
dose
was
lower
than
that
normally
required
for
acute
oral
toxicity/
infectivity
testing
(
108
CFU
per
animal),
although
the
administered
volume
of
5g/
kg
bw
is
in
accordance
with
chemical
guideline
limit
testing
for
acute
oral
toxicity.
Because
the
concentration
of
viable
units
(
CFU)
in
the
TGAI
is
low,
the
infectivity
guideline
dose
levels
are
not
achievable
in
this
volume.
Note
that
the
TGAI
label
guarantee
is
104
 
105
CFU/
g,
which
is
lower
than
the
test
concentration,
and
formulation
of
the
EP
further
dilutes
the
MPCA.
In
addition,
public
literature
shows
C.
purpureum
is
killed
at
37

C,
and
pulmonary
infectivity
testing
suggested
that
C.
purpureum
strain
PFC
2139
is
unlikely
to
be
infective
or
pathogenic,
with
clearance
achieved
by
7
days.
Based
on
the
results
of
the
acute
oral
toxicity
and
acute
pulmonary
toxicity/
infectivity
studies,
and
published
literature
showing
that
C.
purpureum
is
killed
at
37

C,
no
oral
infectivity
testing
is
required
to
assess
the
risks
of
C.
purpureum
strain
PFC
2139.

Acute
pulmonary
toxicity/
pathogenicity
The
acute
pulmonary
toxicity
and
infectivity
of
C.
purpureum
strain
PFC
2139
was
assessed
by
intratracheal
instillation
in
rats.
In
a
preliminary
test
for
lethality,
0.1
mL
of
an
undiluted
suspension
of
C.
purpureum
strain
PFC
2139
containing
approximately
1.76
×
104
CFU
was
dosed
by
intratracheal
administration
to
male
and
female
rats
(
3/
sex).
No
signs
of
toxicity
were
noted
during
the
4­
day
observation
period.
In
the
definitive
study,
male
and
female
rats
(
20/
sex)
were
dosed
with
approximately
1.6
×
104
CFU
of
the
test
substance
(
TS)
and
an
additional
group
of
male
and
female
rats
(
20/
sex)
was
treated
with
autoclaved
test
substance
(
KTS).
Ten
rats
(
5/
sex)
served
as
shelf
controls
(
SC)
and
40
rats
(
20/
sex)
served
as
naive
controls
(
NC).
Animals
were
observed
daily
and
weighed
weekly
for
14
days,
with
two
female
NC
rats
weighed
on
day
16.
Five
animals
per
sex
per
group
from
the
TS,
KTS
and
NC
groups
were
sacrificed
by
carbon
dioxide
asphyxiation
on
days
0,
7
and
14,
and
ten
rats
(
5/
sex)
in
the
SC
group
were
sacrificed
at
study
termination
on
day
14.
These
animals
were
subject
to
gross
necropsy
where
macroscopic
examinations
of
cranial,
thoracic
Chondrostereum
purpureum
strain
PFC
2139
September
20,
2004
Biopesticides
Registration
Action
Document
11
and
abdominal
tissues,
and
microbiological
enumeration
of
the
MPCA
in
the
blood,
brain,
lungs,
liver,
spleen,
kidneys
and
cecum
were
performed.

Clinical
signs
of
rough
hair
coat
and
labored
respiration
were
reported
from
days
2
 
4
in
several
rats
dosed
with
either
live
or
autoclaved
test
substance.
One
female
rat
in
the
NC
group
appeared
lethargic
and
thin
starting
on
day
7,
with
hunched
posture
appearing
on
day
9
and
rough
hair
coat
on
day
13.
Eight
surviving
male
and
three
female
rats
in
the
TS
group,
one
male
and
five
female
rats
in
the
KTS
group,
one
male
and
two
female
rats
in
the
SC
group
and
five
females
in
the
NC
group
lost
weight
during
the
first
week
of
the
study.
Between
days
7
and
14
 
16,
one
female
TS
rat,
three
female
KTS
rats,
and
four
female
NC
rats
lost
weight.
Overall
study
weight
losses
were
recorded
in
one
female
TS
rat
and
four
female
NC
rats.
A
male
TS
rat
died
on
day
2.
This
rat
had
clinically
affected
lung
tissue
but
no
viable
C.
purpureum.
No
explanation
was
provided
on
the
cause
of
death.
One
female
KTS
rat
died
due
to
anesthesia
and
was
replaced.

Chondrostereum
purpureum
was
detected
in
lungs
and
associated
lymph
nodes
after
dosing
with
the
live
substance,
with
clearance
by
day
7.
On
necropsy,
findings
such
as
mottled/
pale
lung
parenchyma,
mottled
lung
intermediate
lobe,
and
mottled
left
lungs
were
noted
in
TS­
and
KTS­
treated
rats.
These
findings
were
consistent
with
the
method
of
dosing
and
were
attributed
to
the
body's
normal
immunological
response
to
a
foreign
substance.
No
gross
lesions
were
noted
in
animals
from
NC
or
SC
groups.
Significantly
increased
lung
and
associated
lymph
node
and
decreased
kidney
weights
reported
in
TS
and
KTS
groups
through
day
14
were
likely
a
result
of
a
normal
immunological
response.
On
day
14,
increased
lung
and
lymph
node
and
decreased
liver
weights
were
observed
for
male
rats
in
the
SC
group.

The
results
of
this
study
are
difficult
to
interpret
because
clinical
signs
were
observed
in
both
treated
and
control
rats.
These
signs
may
have
been
due
to
an
infection
in
the
rat
colony,
affecting
both
treated
and
control
animals,
which
could
have
obscured
the
true
effects
of
C.
purpureum
strain
PFC
2139.
This
acute
pulmonary
toxicity/
infectivity
study
is
therefore
considered
to
be
supplemental.
Additional
data
are
required
to
properly
address
the
mortality
noted
on
day
2
and
the
clinical
signs
(
e.
g.,
loss
of
body
weight)
noted
in
female
NC
rats.
Although
there
was
one
mortality
attributed
to
treatment
at
this
dose,
and
signs
of
toxicity
such
as
weight
loss,
C.
purpureum
strain
PFC
2139
is
unlikely
to
be
infective
or
pathogenic.
Clearance
was
achieved
within
7
days
in
this
study,
and
C.
purpureum
is
known
to
be
killed
at
mammalian
body
temperatures.

Acute
Intraperitoneal
Injection
Infectivity
Mycologic,
Inc.
submitted
a
waiver
request
in
place
of
an
acute
intraperitoneal
injection
infectivity
study.
This
request
was
based
on
the
rationale
that
C.
purpureum
strain
PFC
2139
is
not
infectious
to
mammalian
species,
and
was
supported
by
the
results
of
the
acute
mammalian
testing.

Chondrostereum
purpureum
strain
PFC
2139
was
not
toxic
or
overtly
irritating
in
acute
mammalian
studies,
and
was
not
considered
to
be
infectious
or
overtly
toxic
in
the
acute
pulmonary
toxicity/
infectivity
study.
In
addition,
C.
purpureum
does
not
grow
at
35

C
and
is
killed
at
37

C.
Consequently,
C.
purpureum
strain
PFC
2139
is
unlikely
to
be
infective
to
humans.
Chondrostereum
purpureum
strain
PFC
2139
September
20,
2004
Biopesticides
Registration
Action
Document
12
Acute
dermal
toxicity
The
acute
dermal
toxicity
of
Chontrol
Paste
was
assessed
in
rabbits.
Male
and
female
New
Zealand
White
rabbits
(
5/
sex)
were
prepared
by
clipping
the
dorsal
fur
of
approximately
10%
of
the
body
surface.
Chontrol
Paste
was
applied
to
the
clipped
dorsal
trunk
at
a
dose
of
2000
mg/
kg
bw
or
6.6
 
7.8
×
104
CFU/
animal.
Each
treated
site
was
covered
with
a
12.8
x
11.5
cm
surgical
dressing
and
plastic
film
secured
with
a
lint­
free
cloth
and
elastic
adhesive
bandage.
After
24
hours,
the
dressing
was
removed
and
the
test
substance
washed
away
with
a
water­
moistened
gauze
pad.
The
rabbits
were
observed
twice
daily
for
mortality
(
daily
during
the
weekend),
and
for
clinical
signs
of
toxicity
frequently
on
the
day
after
treatment,
then
at
least
daily
thereafter
for
14
days.
At
study
termination,
the
animals
were
sacrificed
without
necropsy.
There
were
no
mortalities
or
overt
clinical
signs
reported
following
dosing.
There
was
no
edema
in
the
treated
areas,
though
9
of
10
treated
rabbits
had
mild
erythema
that
cleared
by
day
5.
The
remaining
rabbit
exhibited
no
signs
of
irritation.
All
tested
rabbits
gained
weight
steadily
throughout
the
study.

Based
on
these
results,
Chontrol
Paste
is
considered
to
be
of
low
dermal
toxicity
and
the
combined
LD
50
was
greater
than
2000
mg/
kg
bw.

Primary
dermal
irritation
As
part
of
the
dermal
toxicity
study,
dermal
irritation
was
scored
in
accordance
with
standard
guidelines
(
OECD
404;
OPPTS
870.2500).
The
dose
and
duration
of
exposure
exceeded
those
specified
in
the
guidelines,
and
may
be
considered
to
represent
a
worst­
case
exposure
scenario.
Very
slight
to
well­
defined
erythema
was
noted
in
9/
10
rabbits
treated
with
Chontrol
Paste.
Irritation
had
cleared
within
96
hours
following
patch
removal.
The
remaining
rabbit
exhibited
no
signs
of
irritation.
The
maximum
irritation
score
(
MIS)
was
1.2/
8
(
1
h)
and
the
maximum
average
score
(
MAS)
was
0.6/
8
(
24,
48,
72
h).
Based
on
the
MIS
of
1.2/
8
(
1
h)
and
clearance
of
the
symptoms,
Chontrol
Paste
is
considered
to
be
slightly
irritating.
No
signal
words
or
precautionary
statements
are
required
on
the
TGAI
or
EP
product
labels.

Reporting
of
hypersensitivity
incidence
Mycologic,
Inc.
reported
no
incidents
of
hypersensitivity
during
extensive
field
testing.
The
formulation
ingredients
are
common
industrial
or
food
grade
materials.
Two
of
these
formulants
are
considered
to
be
minor
respiratory
or
eye
irritants
when
in
dry
form,
though
they
should
not
be
implicated
in
a
hypersensitive
response
as
a
paste.
The
active
ingredient,
C.
purpureum
strain
PFC
2139,
consists
of
mycelia
only
and
does
not
form
conidia
known
to
induce
allergies
and
hypersensitivity.
Continued
surveillance
and
reporting
of
hypersensitivity
incidents
is
required.

Genotoxic
potential
Chondrostereum
purpureum
has
not
been
reported
to
produce
genotoxins.

Primary
eye
irritation
The
eye
irritation
potential
of
Chontrol
Paste
was
assessed
by
ocular
instillation
in
the
rabbit.
Three
female
New
Zealand
White
rabbits
were
treated
with
0.1
mL
of
undiluted
Chontrol
Paste
(
containing
5.6
×
102
CFU/
g),
in
one
eye.
The
untreated
eye
served
as
a
control.
Animals
were
observed
for
signs
of
ocular
Chondrostereum
purpureum
strain
PFC
2139
September
20,
2004
Biopesticides
Registration
Action
Document
13
irritation
one
hour,
and
1,
2,
and
3
days
after
dosing.
No
corneal
opacity,
iritis,
or
positive
conjunctival
irritation
(
score
>
2)
was
noted
in
any
rabbit.
Redness
of
conjunctiva
was
noted
in
two
animals
at
24
and
48
hours.
The
MIS
was
1.3
(
24
h)
and
the
MAS
was
0.7
(
24,
48
h),
with
clearance
by
72
hours.
Based
on
the
degree
and
the
duration
of
the
irritation
noted,
Chontrol
Paste
is
minimally
irritating
to
the
eyes
of
rabbits.

Reproductive
and
developmental
toxicity
No
reproductive
or
developmental
toxicity
studies
were
submitted.
Because
survival,
replication,
infectivity,
significant
toxicity
or
persistence
of
C.
purpureum
strain
PFC
2139
were
not
observed
in
the
Tier
I
acute
pulmonary
test,
no
reproductive
or
developmental
toxic
effects
are
expected
upon
exposure
to
C.
purpureum.

Neurotoxicity
(
acute,
delayed
and
sub­
chronic)

No
neurotoxicity
studies
were
submitted.
No
neurological
signs
were
noted
in
the
course
of
acute
studies,
and
none
are
expected
to
occur
as
a
result
of
exposure
to
C.
purpureum.

Toxicity
Data
Requirements
OPPTS
GUIDELINE
NUMBER
STUDY
RESULT
MRID#

885.3050
Acute
Oral
Toxicity/
Pathogenicity
in
Rat
­
CD
®
(
SD)
LD
50
greater
than
5g/
kg
bw
or
1.2
×
106
CFU/
kg
bw
No
clinical
signs
indicative
of
toxicity,
no
mortalities
and
no
abnormalities
on
necropsy.
LOW
TOXICITY
Acceptable,
Toxicity
Category
IV
Oral
Infectivity
­
WAIVED
45493303
885.3100
Acute
Dermal
Toxicity/
Pathogenicity
in
Rabbit
­
NZW
LD
50
of
Chondrostereum
purpureum
strain
PFC
2139
in
rats
is
greater
than
3.4x104
CFU/
kg
bw
No
mortalities
or
abnormalities
prior
to
study
termination.
Following
unwrapping,
very
slight
erythema
in
3/
5
females
(

)
and
3/
5
males
(

)
and
well­
defined
erythema
in
1/
5

and
2/
5

was
observed.
Irritation
cleared
within
96
hours
following
patch
removal.

LOW
TOXICITY
Acceptable,
Toxicity
Category
III
45507103
885.3150
Acute
Pulmonary
Toxicity/
Pathogenicity
in
Rat
­
CD
®
(
SD)
LD50
greater
than
1.6
×
104
CFU/
animal
Slightly
Toxic,
Not
Pathogenic
Supplemental
45507102
Chondrostereum
purpureum
strain
PFC
2139
September
20,
2004
Biopesticides
Registration
Action
Document
OPPTS
GUIDELINE
NUMBER
STUDY
RESULT
MRID#

14
870.1300
Acute
Inhalation
(
End­
Use
Product
Chontrol
Paste)
Not
applicable
The
end­
use
product
is
a
non­
volatile
paste.
NA
885.3200
Acute
Intravenous
Toxicity/
Pathogenicity
There
were
no
signs
of
pathogenicity
in
the
Acute
Pulmonary
Toxicity/
Pathogenicity
or
acute
oral
toxicity
studies
that
were
submitted.
Intraperitoneal
exposure
is
unlikely
from
the
paste
application
of
Chondrostereum
purpureum
strain
PFC
2139
to
cut
tree
stumps.
WAIVED
NA
870.2400
Primary
Eye
Irritation
in
Rabbit
­
strain
NZW
Mild
conjunctival
redness
was
noted
in
one
animal
at
the
24
and
48
hour
time
points,
and
in
a
second
animal
at
the
24
hour
time
point.

MINIMALLY
IRRITATING.
Acceptable,
Toxicity
Category
IV
45507104
870.2500
Primary
Dermal
Irritation
in
Rabbit
­
NZW
See
Acute
Dermal
Toxicity/
Pathogenicity
results
above
MINIMALLY
IRRITATING
Acceptable,
Toxicity
Category
IV
45507103
870.2600
Delayed
Contact
Hypersensitivity
in
Guinea
Pigs
No
incidents
reported.
Continued
surveillance
and
reporting
of
hypersensitivity
incidents
is
required.

WAIVED
NA
Integrated
toxicity
and
infectivity
summary
The
acute
toxicity
and
infectivity
studies
submitted
in
support
of
Cp­
PFC
2139
and
Chontrol
Paste
registrations
were
reviewed.
The
data
set
included
acceptable
acute
oral
toxicity,
acute
dermal
toxicity
and
acute
eye
irritation
studies,
and
a
supplemental
acute
pulmonary
toxicity/
infectivity
study.
The
acute
dermal
toxicity
study
also
contained
sufficient
data
to
make
a
decision
on
primary
dermal
irritation.
No
overt
signs
of
toxicity
were
noted
when
C.
purpureum
strain
PFC
2139
was
administered
to
rats
and
rabbits
via
the
oral
and
dermal
routes
of
exposure.
Chondrostereum
purpureum
strain
PFC
2139
appeared
to
be
slightly
toxic
in
the
rat
via
the
intratracheal
route,
however,
additional
data
and
information
are
required
to
properly
interpret
these
results
as
clinical
signs
(
e.
g.,
loss
of
body
weight)
were
noted
in
both
treated
and
control
rats,
and
no
explanation
was
provided
for
the
single
mortality
on
day
2.
In
rabbits,
C.
purpureum
strain
PFC
2139
was
Chondrostereum
purpureum
strain
PFC
2139
September
20,
2004
Biopesticides
Registration
Action
Document
15
slightly
irritating
when
applied
dermally,
and
was
minimally
irritating
when
instilled
into
the
eye.
Chondrostereum
purpureum
is
not
known
to
produce
mammalian
toxins.

b.
Subchronic
Toxicity
and
Chronic
Toxicity
Subchronic
and
chronic
toxicity
testing
was
not
required
because
survival,
replication,
infectivity,
toxicity,
or
persistence
of
the
microbial
agent
were
not
observed
in
the
test
animals
treated
in
the
Tier
1
acute
pulmonary
test.

c.
Effects
on
the
Immune
and
Endocrine
Systems
EPA
is
required
under
section
408(
p)
of
the
FFDCA,
as
amended
by
FQPA,
to
develop
a
screening
program
to
determine
whether
certain
substances
(
including
all
pesticide
active
and
other
ingredients)
"
may
have
an
effect
in
humans
that
is
similar
to
an
effect
produced
by
a
naturally­
occurring
estrogen,
or
other
such
endocrine
effects
as
the
Administrator
may
designate."
Following
the
recommendations
of
its
Endocrine
Disruptor
Screening
and
Testing
Advisory
Committee
(
EDSTAC),
EPA
determined
that
there
is
no
scientific
basis
for
including,
as
part
of
the
screening
program,
the
androgen
and
thyroid
hormone
systems
in
addition
to
the
estrogen
hormone
system.
EPA
also
adopted
EDSTAC's
recommendation
that
the
program
include
evaluations
of
potential
effects
in
wildlife.
For
pesticide
chemicals,
EPA
will
use
FIFRA
and,
to
the
extent
that
effects
in
wildlife
may
help
determine
whether
a
substance
may
have
an
effect
in
humans,
FFDCA
authority
to
require
wildlife
evaluations.
As
the
science
develops
and
resources
allow,
screening
of
additional
hormone
systems
may
be
added
to
the
Endocrine
Disruptor
Screening
Program
(
EDSP).
When
the
appropriate
screening
and/
or
testing
protocols
being
considered
under
the
EPA's
EDSP
have
been
developed,
Chondrostereum
purpureum
strain
PFC
2139
may
be
subjected
to
additional
screening
and/
or
testing
to
better
characterize
effects
related
to
endocrine
disruption.

To
date,
the
EPA
has
no
information
to
suggest
that
Chondrostereum
purpureum
strain
PFC
2139
has
an
effect
on
endocrine
systems.
Moreover,
as
is
expected
from
a
non­
pathogenic
microorganism
that
is
practically
non­
toxic
to
mammals,
the
submitted
toxicity/
pathogenicity
studies
in
rodents
indicated
that
following
several
routes
of
exposure,
the
immune
system
is
still
intact
and
able
to
process
and
clear
the
active
ingredient.

When
the
appropriate
screening
and/
or
testing
protocols
being
considered
under
the
EPA's
Endocrine
Disruptor
Screening
Program
have
been
developed,
Chondrostereum
purpureum
strain
PFC
2139
may
be
subjected
to
additional
screening
and/
or
testing
to
better
characterize
effects
related
to
endocrine
disruption.
Based
on
the
weight
of
the
evidence
of
available
data,
no
endocrine
system­
related
effects
have
been
identified
for
Chondrostereum
purpureum
strain
PFC
2139.

2.
Dose
Response
Assessment
No
toxicological
endpoints
are
identified.
Chondrostereum
purpureum
strain
PFC
2139
September
20,
2004
Biopesticides
Registration
Action
Document
16
3.
Dietary
Exposure
and
Risk
Characterization
(
includes
drinking
water)

a.
Dietary
Exposure
and
Risk
In
the
absence
of
any
toxicological
endpoints,
risk
from
the
consumption
of
residues
is
not
expected
for
the
general
population,
including
infants
and
children.
Chontrol
Paste
will
be
applied
to
freshly
cut
stumps.
It
will
not
be
applied
to
food
or
feed
crops,
hence
exposure
from
food
or
feed
is
unlikely.
Although
C.
purpureum
is
ubiquitous
in
nature,
no
adverse
effects
from
dietary
exposure
have
been
attributed
to
this
species.
Furthermore,
no
adverse
effects
were
observed
in
the
acute
oral
toxicity
study
in
mice
and
there
are
no
reports
of
known
mammalian
toxins
being
produced
by
this
MPCA.

4.
Occupational,
Residential,
School
and
Day
Care
Exposure
and
Risk
Characterization
a.
Occupational
and
Residential
Exposure
and
Risk
The
human
health
and
safety
studies
reviewed
showed
that
Chontrol
Paste
and
C.
purpureum
strain
PFC
2139
is
of
low
acute
toxicity
via
the
oral,
pulmonary
and
dermal
routes
of
exposure,
and
is
not
likely
to
be
pathogenic
by
intratracheal
instillation.
However,
like
all
microbial
pesticides,
C.
purpureum
is
considered
to
be
a
potential
sensitizer,
though
there
have
been
no
reports
of
hypersensitivity
incidents.
Irritation
studies
in
rabbits
showed
that
Chontrol
Paste
was
slightly
irritating
to
the
skin
and
minimally
irritating
to
the
eyes.

The
proposed
use
for
C.
purpureum
is
as
a
biological
herbicide
for
control
of
sprouting
or
regrowth
of
deciduous
trees
and
shrubs
in
rights­
of­
way
and
forest
vegetation
management
situations.
Chontrol
Paste
is
to
be
applied
topically
as
a
paste
on
freshly
cut
stumps
during
summer
or
autumn
at
an
average
rate
of
5
g/
stump
(
approximately
5,000
CFU
per
stump),
depending
on
the
stump
diameter.
When
handled
according
to
label
instructions,
applicator
exposure
is
limited
to
the
dermal
route.
The
potential
for
bystander
exposure
is
minimal
during
application
though
exposure
increases
significantly
after
fructification
has
occurred.
The
potential
for
human
exposure
following
fructification
is
possible
via
inhalation
due
to
the
release
of
basidiospores.
However,
the
intentional
use
of
this
active
ingredient
is
unlikely
to
result
in
a
significant
increase
in
the
natural
background
levels
of
basidiospores
produced
by
this
species,
as
it
is
already
naturally
abundant
throughout
Canada
and
the
United
States.

The
required
standard
personal
protective
equipment
(
including
gloves)
for
Chontrol
Paste
when
handling
this
product
will
minimize
exposure
to
workers.
For
the
TGAI,
it
is
also
recommended
that
the
label
include
standard
personal
protective
equipment,
including
a
dust/
mist
filtering
respirator
(
MSH/
NIOSH
approval
number
prefix
TC­
21C)
or
a
NIOSH
approved
respirator
with
any
N
 
95,
R­
95,
P­
95
or
HE
filter
for
biological
products
to
prevent
inhalation
exposure
as
a
general
precaution
for
all
microbial
pesticide
products,
and
since
the
acute
pulmonary
toxicity/
infectivity
study
was
considered
to
be
supplemental.

b.
Residential,
School
and
Day
Care
Exposure
and
Risk
Characterization
Because
no
toxic
endpoints
for
mammals
have
been
identified,
and
because
no
toxic
effects
have
been
reported
from
limited
human
exposure,
no
toxicity
or
pathogenicity
is
expected
from
aggregate
exposure
of
the
public
via
inhalation,
dermal,
and
oral
routes
of
exposure.
Chondrostereum
purpureum
strain
PFC
2139
September
20,
2004
Biopesticides
Registration
Action
Document
17
5.
Drinking
Water
Exposure
and
Risk
Characterization
Although
heavy
rainfall
might
carry
C.
purpureum
into
aquatic
environments
(
e.
g.,
runoff
from
treated
stumps),
this
MPCA
is
not
expected
to
proliferate
in
aquatic
habitats.
Moreover,
C.
purpureum
is
not
considered
to
pose
a
risk
to
drinking
water.
Both
percolation
through
soil
and
municipal
treatment
of
drinking
water
would
reduce
the
possibility
of
significant
transfer
of
residues
to
drinking
water.
Accordingly,
the
use
of
this
MPCA
on
terrestrial
plants
is
not
anticipated
to
negatively
impact
the
quality
of
drinking
water.

6.
Acute
and
Chronic
Dietary
Risks
for
Sensitive
Subpopulations
Particularly
Infants
and
Children
There
have
been
no
confirmed
reports
of
immediate
or
delayed
allergic
reactions
to
Chondrostereum
purpureum
strain
PFC
2139.

Based
on
the
acute
toxicity
information
discussed
above,
EPA
concludes
that
there
is
a
reasonable
certainty
that
no
harm
will
result
from
aggregate
exposure
to
the
United
States
population,
including
infants
and
children,
to
residues
of
Chondrostereum
purpureum
strain
PFC
2139.
This
includes
all
anticipated
dietary
exposures
and
all
other
exposures
for
which
there
is
reliable
information.
The
EPA
has
arrived
at
this
conclusion
because,
as
discussed
above
in
Unit
B.
Human
Risk
Assessment,
Chondrostereum
purpureum
strain
PFC
2139
is
practically
non­
toxic
to
mammals
and
under
reasonably
foreseeable
circumstances
it
does
not
pose
a
risk.

FFDCA
section
408
provides
that
EPA
shall
apply
an
additional
ten­
fold
margin
of
exposure
(
safety)
for
infants
and
children
in
the
case
of
threshold
effects
to
account
for
pre­
and
post­
natal
toxicity
and
the
completeness
of
the
database,
unless
EPA
determines
that
a
different
margin
of
exposure
(
safety)
will
be
safe
for
infants
and
children.
Margins
of
exposure
(
safety)
are
often
referred
to
as
uncertainty
(
safety)
factors.
In
this
instance,
the
EPA
believes
there
is
reliable
data
to
support
the
conclusion
that
Chondrostereum
purpureum
strain
PFC
2139
is
practically
non­
toxic
to
mammals,
including
infants
and
children,
and,
thus,
there
are
no
threshold
effects;
therefore,
EPA
has
not
used
a
margin
of
exposure
(
safety)
approach
to
assess
the
safety
of
Chondrostereum
purpureum
strain
PFC
2139.
As
a
result,
the
provision
requiring
an
additional
margin
of
exposure
(
safety)
does
not
apply.

7.
Aggregate
Exposure
from
Multiple
Routes
Including
Dermal,
Oral,
and
Inhalation
Because
no
toxic
endpoints
for
mammals
have
been
identified,
and
because
no
toxic
effects
have
been
reported
from
limited
human
exposure,
no
toxicity
or
pathogenicity
is
expected
from
aggregate
exposure
of
the
public
via
inhalation,
dermal,
and
oral
routes
of
exposure.
Worker
exposure
via
inhalation
and
dermal
routes
will
be
minimal
because
the
end­
use
product
is
a
paste
and
personal
protective
equipment
are
required
for
applicators
and
other
handlers.

Based
on
the
available
information,
EPA
concludes
that
there
is
a
reasonable
certainty
that
no
harm
will
result
from
aggregate
exposure
to
the
United
States
population,
including
infants
and
children,
to
residues
of
Chondrostereum
purpureum
strain
PFC
2139.
This
includes
all
anticipated
dietary
exposures
and
all
other
exposures
for
which
there
is
reliable
information.
EPA
has
arrived
at
this
conclusion
because
Chondrostereum
purpureum
strain
PFC
2139
shows
no
evidence
of
toxicity
or
infectivity
in
any
animal.

8.
Cumulative
Effects
Chondrostereum
purpureum
strain
PFC
2139
September
20,
2004
Biopesticides
Registration
Action
Document
18
Chondrostereum
purpureum
strain
PFC
2139
is
practically
non­
toxic
to
mammals
and
there
is
an
extremely
low
use
rate.
No
mechanism
of
toxicity
in
mammals
has
been
identified
for
this
organism.
Therefore,
no
cumulative
effect
with
other
related
organisms
is
anticipated.
Currently,
there
are
no
other
Chondrostereum
purpureum
products
registered
in
the
U.
S.

C.
Environmental
Assessment
1.
Environmental
Fate
Several
published
papers
and
field
trials
describing
the
environmental
fate
of
Chondrostereum
purpureum
strain
PFC
2139
following
its
use
as
a
biological
herbicide
were
submitted
for
review.
These
included
analyses
of
genetic
variation
in
native
populations
of
C.
purpureum,
environmental
fate
field
trials
and
environmental
fate
models
which
predicted
sporulation
and
spore
dispersal
patterns.

Chondrostereum
purpureum
is
ubiquitous
in
northern
North
America,
south
to
Virginia
in
the
east
and
to
northern
California
in
the
west,
and
in
temperate,
moist
zones
around
the
world.
Optimal
vegetative
growth
occurs
between
20
and
25

C.
No
growth
occurs
at
35

C,
but
cultures
incubated
at
35

C
can
resume
normal
growth
on
incubation
at
25

C.
Incubation
at
37

C
for
7
days
is
lethal
(
Wall
1986;
Ekramoddoullah
et
al.
1993).
Rainfall
appears
to
be
the
primary
requirement
for
sporulation.
Spiers
(
1985)
observed
sporulation
only
in
basidiocarps
that
had
been
immersed
in
water
or
in
those
that
had
been
grown
on
agar
medium
and
had
a
water
content
of

75%.
Optimum
sporulation
is
reported
at
18

C
(
Spiers
1985;
Dye
1974),
and
spores
germinate
within
24
hours
at
temperatures
between
17.5
and
28

C
on
media
with

75%
water
content,
though
germination
also
occurs
at
5

C
(
Spiers
and
Hopcroft
1988).
Sporophores
are
reported
to
retain
viability
despite
12
months
of
dehydration
(
Buller
1958)
and
can
resume
basidiospore
production
within
6
 
8
hours
of
re­
hydration
(
Spiers
and
Hopcroft
1988).

Genetic
Characterization
of
Native
Populations
of
Chondrostereum
purpureum
The
degree
of
diversity
and
geographic
or
host
specialization
was
investigated
in
naturally
occurring
C.
purpureum
populations
using
several
molecular
techniques.

Ekramoddoullah
et
al.
(
1993)
found
little
phenotypic
variation
in
enzyme
biochemistry,
growth
temperature,
virulence
and
protein
profiles
among
isolates
of
C.
purpureum
collected
from
New
Brunswick,
Vancouver
Island
(
British
Columbia)
and
southern
mainland
British
Columbia.
Any
variation
that
was
observed
did
not
appear
to
be
related
to
host
type
or
geographical
location.

Considerable
genetic
diversity
was
reported
by
Gosselin
et
al.
(
1999)
in
93
isolates
from
four
of
five
Canadian
microbial
pesticide
ecozones
following
analysis
of
22
randomly
amplified
polymorphic
DNA
(
RAPD)
amplicons.
However,
the
population
appeared
to
be
continuously
distributed,
and
no
trends,
with
respect
to
ecological
or
host
origins,
were
identified.
Statistical
analysis
indicated
that
most
of
the
total
gene
diversity
existed
within
populations,
suggesting
that
the
population
is
highly
heterogeneous,
and
that
molecular
variability
is
continuously
distributed
across
the
sample
population.
Because
short,
non­
specific
primers
are
used
at
low
stringency
in
RAPD
analysis,
reaction
conditions
must
be
standardized
for
results
to
be
consistent.
Standard
reaction
conditions
were
maintained
throughout
this
study.
Chondrostereum
purpureum
strain
PFC
2139
September
20,
2004
Biopesticides
Registration
Action
Document
19
Restriction
fragment
length
polymorphism
(
RFLP)
in
the
large
non­
transcribed
spacer
(
NTS­
L)
region
within
the
ribosomal
DNA
(
rDNA)
repeat
of
107
C.
purpureum
isolates
collected
from
Europe,
New
Zealand
and
North
America,
was
reported
by
Ramsfield
et
al.
(
1996).
Three
distinct
restriction
patterns,
or
nuclear
types
(
I,
II
and
III),
were
identified
using
the
restriction
endonuclease
HaeIII;
type
I
is
found
in
isolates
from
North
America,
Europe
and
New
Zealand,
type
II
in
North
American
isolates
only,
and
type
III
only
in
isolates
from
Europe
and
New
Zealand.
Type
I
predominates
in
eastern
North
America,
and
type
II
in
the
west,
though
both
types
are
found
on
each
coast.
Types
I
and
II
exist
at
equal
frequency
in
central
North
America,
suggesting
that
gene
transfer
occurs
across
the
continent
by
way
of
airborne
basidiospores.

Similarly,
two
mitochondrial
haplotypes
(
types
I
and
II)
were
identified
upon
digestion
of
a
mitochondrial
DNA­
specific
sequence
characterized
amplified
region
(
SCAR)
with
the
restriction
endonuclease
NsiI
(
Ramsfield
et
al.
1999).
Both
haplotypes
were
present
in
all
geographic
regions
surveyed.
In
New
Zealand,
the
haplotype
distribution
was
roughly
equal,
whereas
in
Europe
and
North
America,
haplotype
I
was
present
at
twice
the
frequency.
In
North
America,
type
I
was
predominant
in
the
east,
but
the
haplotype
distribution
was
nearly
equal
in
western
isolates.

Although
the
two
studies
by
Ramsfield
et
al.
(
1996
and
1999)
suggested
geographic
polarization
of
C.
purpureum
populations
across
North
America,
the
polymorphism
identified
in
each
was
in
a
single
restriction
site
in
a
non­
coding
portion
of
the
genome
where
variability
might
be
expected.
A
polarized
distribution
with
a
transcontinental
frequency
gradient
might
be
expected
from
a
single
polymorphism.

Field
Studies
RAPD
analysis
and
the
SCAR
marker
AP­
D13
were
used
to
track
the
fate
of
deployed
strains
of
C.
purpureum.

Becker
et
al.
(
1999)
developed
a
species
specific
marker,
APN­
1,
which
amplifies
a
500
base
pair
(
bp)
fragment
from
the
intergenic
region
of
the
rDNA.
This
marker
differentiates
C.
purpureum
from
other
basidiomycetes.
As
well,
a
SCAR
marker,
designated
AP­
D13,
was
discovered
to
produce
a
DNA
fingerprint
that
is
unique
to
each
strain
of
C.
purpureum.
These
markers
were
applied
in
a
field
study,
in
which
stump
sections
of
sitka
alder
(
Alnus
sinuata)
and
trembling
aspen
(
P.
tremuloides)
were
sampled
four
months
after
treatment
with
C.
purpureum
mycelial
paste
prepared
from
strains
PFC
2139
and
JAM6.
No
C.
purpureum
of
any
strain
was
detected
using
the
species­
specific
APN­
1
primer
in
any
of
the
control
stumps.
However,
the
incidence
of
secondary,
spore­
borne
infection
could
not
be
determined
since
spore­
bearing
fruiting
bodies
(
sporophores)
do
not
develop
for
one
to
three
years
after
primary
infection.

The
occurrence
of
silverleaf
disease
in
non­
target
forest
trees
surrounding
powerline
rights­
of­
way
was
studied
by
Gosselin
et
al.
(
1999).
Non­
target
infection
was
assessed
after
the
deployment
of
two
native
isolates
of
C.
purpureum,
strains
IB
and
CQP1,
in
undisturbed
areas
and
at
sites
where
trees
had
been
cut.
The
overall
infection
frequency
was
15%
in
disturbed
areas
compared
to
0.3%
in
undisturbed
areas.
It
is
not
clear
if
this
difference
was
due
to
wounding,
or
if
it
was
an
artifact
of
different
sampling
techniques.
In
the
intact
sites,
infection
was
assessed
by
sporophore
counts,
whereas
in
wounded
sites
wood
samples
were
cultured,
and
many
culture­
positive
stumps
did
not
display
sporophores.
There
was
no
correlation
between
infection
frequency
and
proximity
to
the
release
site.
RAPD
analysis
showed
that
at
least
85%
of
these
infections
did
not
originate
from
the
introduced
strains,
therefore
non­
target
silverleaf
disease
observed
on
Chondrostereum
purpureum
strain
PFC
2139
September
20,
2004
Biopesticides
Registration
Action
Document
20
sites
adjacent
to
areas
where
C.
purpureum
has
been
used
as
a
biological
herbicide
should
not
be
presumed
to
be
due
to
the
biological
treatment.

The
potential
for
spread
of
C.
purpureum
infection
between
trees
through
the
root
system
was
studied
by
the
applicant.
Stems
and
roots
of
trembling
aspen
(
P.
tremuloides)
inoculated
with
C.
purpureum
PFC
2139
one
year
earlier
were
destructively
sampled
and
screened
for
the
presence
of
the
fungus
using
the
species­
specific
rDNA
PCR
primer
APN­
1
described
by
Becker
et
al.
(
1999).
Treated
stems
in
PFC
2139­
treated
plots
all
demonstrated
complete
mortality,
but
no
amplification
of
the
PCR
product
specific
to
C.
purpureum
was
seen
in
treated
or
control
root
samples.
A
positive
control
sample
extracted
from
infected
alder
stemwood
showed
an
amplification
product
typical
of
C.
purpureum,
even
when
diluted
1/
6000.

The
risk
of
introducing
genetic
material
into
resident
C.
purpureum
populations
by
application
of
a
biocontrol
strain
as
a
mycoherbicide
was
studied
by
the
applicant.
Isolates
of
C.
purpureum
were
collected
immediately
before
C.
purpureum
biocontrol
strains
PFC
2139
and
JAM6
were
applied
as
part
of
a
field
trial.
After
18
months,
trees
were
cut
to
a
height
of
one
meter
at
distances
of
50,
700
and
1500
meters
from
the
treated
site
to
act
as
"
spore
traps".
These
trees
were
monitored
over
12
 
18
months
for
the
presence
of
sporophores,
and
wood
samples
were
periodically
taken
for
culture.
The
genetic
similarity
between
pre­
trial
isolates
and
each
of
the
introduced
strains,
and
between
spore
trap
isolates
and
the
introduced
strains,
was
compared
using
the
AP­
D13
SCAR
primer
pair
described
in
Becker
et
al.
(
1999).
No
significant
differences
between
pre­
and
post­
treatment
isolates
were
detected.

Taken
together,
these
studies
indicate
that
there
is
little
risk
that
the
introduction
of
a
single
biocontrol
isolate
will
overwhelm
the
native
C.
purpureum
gene
pool.

Environmental
Modeling
In
a
study
by
De
Jong
et
al.
(
1990),
spore
emission
(
release)
was
measured,
and
spore
dispersal
patterns
were
predicted
by
a
Gaussian
plume
model
(
GPM).
Based
on
spore
dispersal
data
applicable
to
a
maximum
of
9%
of
the
days
and
a
risk
limit
expected
to
result
in
infection
only
19%
of
the
time,
the
study
found
that
nontarget
trees
within
500
m
of
a
treatment
site
would
be
at
appreciable
risk
and
trees
at
5000
m
would
be
at
negligible
risk
of
infection
with
C.
purpureum.
However,
spore
densities
at
distances
of
500
and
5000
m
were
predicted
to
be
<
1
spore/
m3
for
the
majority
of
days,
a
density
that
is
not
considered
high
enough
to
cause
infection.
Because
the
values
selected
for
input
into
the
GPM
were
extremely
conservative,
the
risk
is
probably
overestimated.
As
well,
the
environmental
input
data
for
the
GPM
were
typical
of
conditions
in
the
Netherlands
which,
compared
to
conditions
in
North
America,
are
expected
to
result
in
higher
levels
of
sporulation.

North
American
conditions
were
assessed
in
a
second
study
by
De
Jong
et
al.
(
1996)
conducted
in
British
Columbia.
Instead
of
modeling
spore
density
and
dispersal
patterns,
sporophores
were
counted,
presumably
on
the
assumption
that
increased
fructification
would
increase
the
airborne
spore
density.
Natural
fructification
was
surveyed
in
both
healthy
stands
and
areas
with
significant
tree
wounding.
The
significantly
higher
incidence
of
natural
fructification
found
in
wounded
plots
(
73
 
100%),
as
compared
to
healthy
plots,
suggests
that
wounding,
and
not
spore
density,
was
the
predominant
factor
determining
infection.
The
difference
in
fructification
before
and
after
the
introduction
of
C.
purpureum
was
estimated
and
found
to
be
of
the
same
order
of
magnitude,
or
less,
than
the
level
of
natural
fructification.
Chondrostereum
purpureum
strain
PFC
2139
September
20,
2004
Biopesticides
Registration
Action
Document
21
Integrated
Environmental
Fate
Summary
The
active
ingredient,
C.
purpureum,
is
described
in
several
references
as
ubiquitous
to
northern
North
America
south
to
Virginia
in
the
East
and
to
northern
California
in
the
west.
The
extensive
genetic
diversity
and
out­
crossing
nature
of
C.
purpureum
isolates
indicate
that
deployment
of
a
single
isolate
across
Canada
and
the
United
States
will
have
a
minimal
impact
on
the
resident
population.

Chontrol
Paste
is
to
be
applied
topically
as
a
mycelial
paste
formulation,
therefore
exposure
of
terrestrial
and
aquatic
organisms
to
C.
purpureum
will
be
minimal
at
the
time
of
application.
Furthermore,
environmental
fate
models
of
C.
purpureum
sporulation
and
spore
dispersal
suggest
that
the
additional
spore
density
due
to
deployment
of
C.
purpureum
strain
PFC
2139
as
a
biological
control
agent
will
be
equal
in
magnitude
to,
or
less
than,
the
naturally
occurring
spore
density
from
resident
populations
of
C.
purpureum.

Empirical
studies
indicate
that
the
additional
spore
load
due
to
the
use
of
C.
purpureum
would
be
of
the
same
order
of
magnitude,
or
less
than,
the
natural
spore
load,
and
that
tree
wounding,
not
spore
load
is
the
primary
determinant
of
infection.
Therefore,
no
buffer
zone
around
fruit
trees
or
ornamentals
that
may
be
pruned
or
grafted
is
required
since
non­
target
healthy
trees
are
at
negligible
risk,
while
wounded
trees
would
likely
be
equally
vulnerable
to
resident
populations
of
C.
purpureum
as
they
would
C.
purpureum
strain
PFC
2139.

2.
Ecological
Toxicity
Freshwater
Aquatic
Invertebrate
Toxicity/
Pathogenicity
Mycologic,
Inc.
submitted
a
request
to
waive
freshwater
aquatic
invertebrate
toxicity/
pathogenicity
testing,
based
on
the
rationale
that
the
use
of
C.
purpureum
strain
PFC
2139
as
a
biological
control
agent
is
not
expected
to
produce
any
adverse
effects
on
aquatic
invertebrates.
This
rationale
was
supported
with
results
of
literature
searches
in
various
databases.
No
reports
identified
C.
purpureum
as
a
producer
of
toxins
or
as
a
pathogenic/
infectious
agent
that
affects
aquatic
arthropods.

Because
Chontrol
Paste
is
to
be
applied
topically
as
a
mycelial
paste
formulation,
the
inoculum
will
be
restricted
to
the
cut
surfaces
of
stumps,
and
no
spray
drift
is
expected.
Therefore,
aquatic
exposure
to
C.
purpureum
will
be
minimal
at
the
time
of
application.
Heavy
rainfall
might
carry
C.
purpureum
into
aquatic
environments
(
i.
e.,
runoff
from
treated
stumps),
however
the
MPCA
is
not
expected
to
proliferate
in
aquatic
habitats.
In
water,
terrestrial
fungi
are
normally
present
in
a
mainly
dormant
state,
growing
and
sporulating
only
in
greatly
enriched
conditions
(
Suberkropp
and
Klug
1976).
Fungi
imperfecti
and
ascomycetes
are
the
more
frequently
encountered
fungi
in
aquatic
environments
while
basidiomycetes
play
only
a
minor
role
(
Jones
1982;
Rheinheimer
1992).
Among
the
aquatic
basidiomycetes
are
Leptosporomyces,
Bulbillomyces,
Subulicystidium,
Fibulomyces
and
Sistotrema
ssp.(
Jones
1982;
Goh
and
Hyde
1996)
which
are
within
the
same
family
(
Corticiaceae)
as
C.
purpureum.
Other
aquatic
basidiomycetes
are
more
distantly
related
and
belong
to
the
orders
Ustilginales,
Polyporales,
Teremellales
or
the
class
Gateromycetes
(
Jones
1982;
Goh
and
Hyde
1996).
Furthermore,
environmental
fate
models
of
C.
purpureum
sporulation
and
spore
dispersal
suggest
that
the
additional
spore
density
due
to
the
use
of
C.
purpureum
strain
PFC
2139
as
a
biological
control
agent,
will
be
equal
in
magnitude
to,
or
less
than,
the
naturally
occurring
spore
density
from
resident
populations
of
C.
purpureum.
Chondrostereum
purpureum
is
a
ubiquitous
organism
in
the
forest
ecosystem
and
it
is
likely
that
a
large
number
of
spores
are
naturally
deposited
in
aquatic
environments.
Despite
this
exposure,
no
adverse
effects
on
aquatic
arthropod
or
aquatic
invertebrate
species
have
been
noted
in
the
Chondrostereum
purpureum
strain
PFC
2139
September
20,
2004
Biopesticides
Registration
Action
Document
22
published
literature.
The
incremental
increase
in
exposure
due
to
run­
off
subsequent
to
the
application
of
Chontrol
Paste
and
sporulation
in
the
years
following
infection
is
not
expected
to
increase
the
likelihood
of
adverse
effects
on
aquatic
arthropod
species.

Based
on
predicted
minimal
increased
exposure
and
the
absence
of
reports
in
published
literature
associating
C.
purpureum
with
disease
in
aquatic
invertebrates
or
arthropods,
the
proposed
use
of
Chontrol
Paste
is
not
expected
to
result
in
adverse
effects
on
aquatic
invertebrates.
Consequently,
no
aquatic
invertebrate
testing
is
required
to
further
assess
the
risks
of
Chontrol
Paste.
The
request
for
a
waiver
of
aquatic
invertebrate
testing
is
accepted.

Avian
Toxicity/
Pathogenicity
Mycologic,
Inc.
submitted
a
justification
for
the
waiver
of
avian
oral
toxicity
and
avian
pulmonary/
inhalation/
injection
studies,
based
on
the
rationale
that
the
use
of
C.
purpureum
strain
PFC
2139
as
a
biological
control
agent
is
not
expected
to
produce
any
adverse
effects
in
birds.
This
rationale
was
supported
with
results
of
literature
searches
in
various
databases.
No
reports
of
adverse
effects
that
identified
C.
purpureum
as
a
producer
of
toxins
or
as
a
pathogenic/
infectious
agent
affecting
avian
fauna,
were
found.
This
finding,
according
to
the
scientific
rationale,
is
supported
by
the
results
of
human
health
and
safety
testing
concerning
the
infectivity,
toxicity
and
eye
irritation
potential
of
C.
purpureum
strain
PFC
2139
on
laboratory
mammals.

Acute
mammalian
toxicity
testing
showed
that
C.
purpureum
strain
PFC
2139
is
not
toxic
via
the
oral
route.
Via
the
intratracheal
route,
C.
purpureum
strain
PFC
2139
appeared
to
be
slightly
toxic
but
not
pathogenic
in
the
rat,
however,
additional
data
and
information
are
required
to
properly
interpret
these
results
as
clinical
signs
(
e.
g.,
loss
of
body
weight)
were
noted
in
both
treated
and
control
rats.
Chontrol
Paste
was
minimally
toxic
(
irritating)
via
the
dermal
route
and
was
practically
non­
irritating
via
the
ocular
route.
Requests
to
waive
mammalian
acute
oral
infectivity,
and
acute
intraperitoneal
injection
infectivity
testing
were
accepted.
Moreover,
C.
purpureum
is
not
thermo­
tolerant
and
does
not
grow
at
35

C.
Temperatures
over
37

C
for
sustained
periods
(
7
 
33
days)
are
lethal
to
C.
purpureum.
The
normal
body
temperature
of
ducks
and
quails
is
approximately
40

C.

Based
on
lack
of
evidence
of
adverse
effects
in
the
published
literature,
lack
of
significant
toxicity
or
infectivity
in
acute
mammalian
toxicity/
infectivity
studies,
and
the
inability
of
C.
purpureum
to
grow
at
high
temperatures,
the
proposed
use
pattern
of
Chontrol
Paste
is
not
expected
to
result
in
adverse
effects
on
avian
species.
Consequently,
no
avian
testing
is
required
to
further
assess
the
risks
of
Chontrol
Paste
on
avian
wildlife.
The
request
for
a
waiver
of
avian
oral
and
avian
pulmonary/
inhalation/
injection
testing
is
accepted.

Freshwater
Fish
Toxicity/
Pathogenicity
Mycologic,
Inc.
submitted
a
request
to
waive
fish
testing,
based
on
the
rationale
that
the
use
of
C.
purpureum
strain
PFC
2139
as
a
biological
control
agent
is
not
expected
to
produce
any
adverse
effects
on
fish
species.
This
rationale
was
supported
with
results
of
literature
searches
in
various
databases.
No
reports
of
adverse
effects
which
identifying
C.
purpureum
as
a
producer
of
toxins
or
as
a
pathogenic/
infectious
agent
that
affects
fish
were
found.
Chondrostereum
purpureum
strain
PFC
2139
September
20,
2004
Biopesticides
Registration
Action
Document
23
As
noted
in
the
discussion
in
the
Freshwater
Aquatic
Invertebrate
toxicity/
pathogenicity
section,
exposure
to
C.
purpureum
strain
PFC
2139
will
be
minimal
at
the
time
of
application.
No
adverse
effects
on
fish
have
been
noted
in
published
literature
despite
its
ubiquitous
nature.
The
incremental
increase
in
spore
density
due
to
biocontrol
operations
is
not
expected
to
increase
the
likelihood
of
adverse
effects
on
fish.

Based
on
predicted
minimal
increased
exposure
and
the
absence
of
reports
associating
C.
purpureum
with
disease
in
fish
in
published
literature,
the
proposed
use
of
Chontrol
Paste
is
not
expected
to
result
in
adverse
effects
on
fish
species.
Consequently,
no
fish
testing
is
required
to
further
assess
the
risks
of
Chontrol
Paste.
The
request
for
a
waiver
of
fish
testing
is
accepted.

Wild
Mammal
Toxicity/
Pathogenicity
No
additional
testing
is
required
to
further
assess
the
risks
of
Chontrol
Paste
to
wild
mammals,
as
no
significant
adverse
effects
were
noted
in
the
published
literature
or
in
any
of
the
acute
oral
toxicity,
dermal
toxicity,
and
dermal
and
eye
irritation
studies
described
in
Unit
B,
Human
Risk
Assessment.
Chondrostereum
purpureum
strain
PFC
2139
appeared
to
be
slightly
toxic
but
not
pathogenic
in
the
rat
via
the
intratracheal
route,
though
additional
data
and
information
are
required
to
properly
interpret
these
results.
Chondrostereum
purpureum
does
not
grow
at
35

C
and
temperatures
above
37

C
for
sustained
periods
(
7
 
33
days)
are
lethal
to
C.
purpureum.

Nontarget
Plant
Toxicity/
Pathogenicity
Terrestrial
plants:
Mycologic,
Inc.
submitted
a
justification
for
a
data
waiver
from
terrestrial
plant
testing.
According
to
the
scientific
rationale,
the
impact
of
C.
purpureum
on
non­
target
terrestrial
plants
is
limited
due
to:
(
1)
fragile
basidiospores
(
Spiers
1985;
Spiers
and
Hopcroft
1988),
(
2)
the
requirement
for
a
wound,
preferably
a
fresh
wound,
to
gain
entry
into
the
host
(
Brooks
and
Moore
1926),
and
(
3)
the
ability
of
healthy
hosts
to
fend
off
or
compartmentalize
infections.
The
rationale
also
noted
that,
based
on
the
biological
properties
of
C.
purpureum,
it
is
unlikely
that
a
highly
virulent
isolate
would
survive
long
as
a
distinct
entity
despite
the
fact
that
this
species
varies
in
virulence
(
Ekramoddoulah
et
al.
1993).
Its
outbreeding
tendency
and
absence
of
a
clonally
dispersed
propagule
such
as
conidia
indicate
that
highly
virulent
isolates
would
recombine
with
resident
populations.
Furthermore,
selective
pressure
towards
virulence
is
low
because
the
fungus
can
survive
and
proliferate
as
a
saprophyte.

In
North
America,
C.
purpureum
is
a
ubiquitous
organism
that
is
a
natural
component
in
the
forest
ecosystem,
but
is
rarely
reported
as
a
disease
of
fruit
trees
or
forest
crops
(
Browne,
1968).
Reported
cases
of
silverleaf
disease
are
often
associated
with
already
weakened
deciduous
trees.
Infections
on
coniferous
trees
have
been
reported,
but
these
are
limited
as
other
saprophytes
apparently
crowd
out
C.
purpureum
from
infected
tissues.
Chondrostereum
purpureum
is
not
known
to
be
a
pathogen
of
herbaceous
plants.
In
susceptible
host
species,
the
presence
of
a
fresh
wound,
and
not
the
basidiospore
load,
is
the
main
determinant
of
a
non­
target
host
tree's
risk
of
infection.
The
susceptibility
of
a
tree
is
dependent
on
its
health
status.
Healthy
host
trees
have
been
reported
to
successfully
fight
off
infection
by
physically
compartmentalizing
invading
C.
purpureum
(
Wall
1991).

Non­
target
terrestrial
plant
exposure
is
not
expected
to
increase
significantly
with
use
of
C.
purpureum
as
a
biological
control
agent.
Chontrol
Paste
is
to
be
applied
topically
as
a
mycelial
paste
formulation
(
about
5.0
Chondrostereum
purpureum
strain
PFC
2139
September
20,
2004
Biopesticides
Registration
Action
Document
24
mL
per
a
cut
surface
of
a
2
to
6
cm
stump,
approximately
5,000
CFU
per
stump)
and,
therefore,
exposure
to
non­
target
terrestrial
plants
will
be
minimal
at
the
time
of
application.
Furthermore,
C.
purpureum
is
not
likely
to
spread
from
treated
stumps
to
neighboring
trees
via
the
root
system,
and
environmental
fate
models
of
C.
purpureum
sporulation
and
spore
dispersal
indicate
that
the
additional
spore
density
due
to
the
use
of
C.
purpureum
as
a
biological
control
agent,
will
be
equal
in
magnitude
to,
or
less
than,
the
naturally
occurring
spore
density
from
resident
populations
of
C.
purpureum.

Based
on
the
above­
noted
information,
C.
purpureum
strain
PFC
2139
has
the
potential
to
affect
non­
target
terrestrial
plant
species,
particularly
deciduous
trees,
but
the
risks
should
be
no
greater
than
from
background
levels
of
this
fungal
species.
Consequently,
no
terrestrial
plant
testing
is
required
to
further
assess
the
risks
of
Chontrol
Paste
on
terrestrial
plant
species.
The
request
for
a
waiver
of
terrestrial
plant
testing
is
accepted.

Aquatic
plants:
In
the
aquatic
plant
toxicity/
pathogenicity
study,
the
impact
of
C.
purpureum
spores
was
assessed
by
exposing
two
types
of
aquatic
plant
species,
Elodea
sp.
and
Lemna
minor,
to
cut
alder
logs
bearing
sporophores
of
C.
purpureum
strain
PFC
2139.
This
study,
however,
was
classified
as
unacceptable
due
to
uncertainties
regarding
the
number
of
C.
purpureum
spores
that
was
administered
during
treatment.

The
waiver
rationale
argued
that
the
use
of
C.
purpureum
strain
PFC
2139
as
a
biological
control
agent
should
not
be
expected
to
produce
any
detrimental
effects
on
aquatic
plants.
This
rationale
was
supported
with
a
review
of
relevant
literature
detailing
known
host
range
and
results
of
literature
searches
in
various
databases.
No
reports
of
adverse
effects
that
identified
C.
purpureum
as
a
producer
of
toxins
that
affect
aquatic
plants
or
as
a
pathogenic/
infectious
agent
to
aquatic
plants
were
found.

Exposure
to
C.
purpureum
strain
PFC
2139
would
be
minimal
to
aquatic
plants
at
the
time
of
application.
No
adverse
effects
on
aquatic
plants
have
been
noted
in
the
published
literature
despite
its
ubiquitous
nature.
The
incremental
increase
in
spore
production
in
the
years
following
application
is
not
expected
to
increase
the
likelihood
of
adverse
effects
on
aquatic
plant
species.

Based
on
predicted
minimal
increased
exposure
and
the
absence
of
reports
associating
C.
purpureum
with
disease
in
aquatic
plants,
the
proposed
use
of
Chontrol
Paste
is
not
expected
to
result
in
adverse
effects
on
aquatic
plants.
Consequently,
no
additional
aquatic
plant
testing
is
required.
The
request
for
a
waiver
of
aquatic
plant
testing
is
accepted.

Nontarget
Insect
and
Honeybee
Toxicity/
Pathogenicity
Mycologic,
Inc.
submitted
a
request
to
waive
terrestrial
arthropod
and
terrestrial
insect
testing,
based
on
the
rationale
that
the
use
of
C.
purpureum
strain
PFC
2139
as
a
biological
control
agent
is
not
expected
to
produce
any
adverse
effects
on
arthropod
and
insect
species.
This
rationale
was
supported
with
results
of
literature
searches
in
various
databases.
No
reports
of
adverse
effects
which
identified
C.
purpureum
as
a
producer
of
toxins
or
as
a
pathogenic/
infectious
agent
that
affects
arthropods
were
found.

Because
Chontrol
Paste
is
to
be
applied
topically
as
a
paste
formulation,
the
inoculum
will
be
restricted
to
the
cut
surfaces
of
stumps,
and
no
spray
drift
is
expected.
Therefore,
terrestrial
arthropod
exposure
to
C.
purpureum
will
be
minimal
at
the
time
of
application.
Furthermore,
environmental
fate
models
of
C.
purpureum
sporulation
and
spore
dispersal
suggest
that
the
additional
spore
density
due
to
the
use
of
C.
Chondrostereum
purpureum
strain
PFC
2139
September
20,
2004
Biopesticides
Registration
Action
Document
25
purpureum
as
a
biological
control
agent
will
be
equal
in
magnitude
to,
or
less
than,
the
naturally
occurring
spore
density
from
resident
populations
of
C.
purpureum.

Chondrostereum
purpureum
is
a
ubiquitous
organism
that
is
a
natural
component
of
the
forest
ecosystem
and
no
adverse
effects
on
terrestrial
arthropods
due
to
natural
populations
of
C.
purpureum
have
been
noted
in
the
published
literature.
The
incremental
increase
in
spore
density
is
not
expected
to
increase
the
likelihood
of
adverse
effects
on
terrestrial
arthropods.
Recently
felled
and
treated
areas
may
attract
a
range
of
arthropod
species
including
wood­
boring
insects
which
might
be
exposed
to
the
MPCA
by
feeding
in
treated
stumps.
Many
insects,
however,
do
not
colonize
wood
until
the
later
stages
of
decay
and
it
is
likely
that
stumps
would
be
naturally
colonized
by
resident
populations
of
C.
purpureum
in
any
case,
if
left
untreated.

Based
on
predicted
minimal
increased
exposure
and
the
absence
of
reports
in
published
literature
associating
C.
purpureum
with
disease
in
arthropods,
the
proposed
use
of
Chontrol
Paste
is
not
expected
to
result
in
adverse
effects
in
terrestrial
arthropods
including
insects.
Consequently,
no
non­
target
insect
toxicity/
pathogenicity
testing
or
honey
bee
toxicity/
pathogenicity
testing
is
required
to
further
assess
the
risks
of
Chontrol
Paste.
The
request
for
a
waiver
of
non­
target
insect
and
honey
bee
toxicity/
pathogenicity
testing
is
accepted.

Estuarine
and
Marine
Animals
Toxicity/
Pathogenicity
No
other
data
or
scientific
rationales
were
submitted
and
no
additional
data
are
required
to
assess
the
impact
of
C.
purpureum
strain
PFC
2139
on
estuarine
and
marine
organisms.
Based
on
existing
host­
specificity
data
and
the
proposed
use
pattern
of
Chontrol
Paste,
the
potential
for
adverse
effects
of
C.
purpureum
strain
PFC
2139
on
other
estuarine
and
marine
non­
target
organisms
is
considered
minimal
to
non­
existent.

Eco­
Toxicology
Summary
Guideline
Study
Status
885.41
Avian
inhalation
toxicity/
pathogenicity
Waived
based
on
a
limited
potential
for
risk.

885.405
Avian
oral
toxicity/
pathogenicity
Waived
based
on
a
limited
potential
for
risk.

885.42
Freshwater
fish
toxicity/
pathogenicity
Waived
based
on
a
limited
potential
for
risk.

885.424
Freshwater
Aquatic
Invertebrate
toxicity/
pathogenicity
Waived
based
on
a
limited
potential
for
risk.

885.415
Wild
Mammal
toxicity/
pathogenicity
Waived
based
on
a
limited
potential
for
risk.

885.43
Nontarget
Plant
toxicity/
pathogenicity
Waived
based
on
a
limited
potential
for
risk.

885.434
Nontarget
Insect
toxicity/
pathogenicity
Waived
based
on
a
limited
potential
for
risk.

885.438
Honey
Bee
toxicity/
pathogenicity
Waived
based
on
a
limited
potential
for
risk.

885.4280
Estuarine
and
Marine
Animals
toxicity/
pathogenicity
Waived
based
on
a
limited
potential
for
risk.
Chondrostereum
purpureum
strain
PFC
2139
September
20,
2004
Biopesticides
Registration
Action
Document
26
Integrated
Environmental
Toxicology
Summary
Chondrostereum
purpureum
is
a
cosmopolitan
fungus
widely
distributed
in
over
40
different
countries
on
all
continents
except
Antarctica.
In
North
America,
it
can
be
found
in
Canada
and
the
northern
regions
of
the
United
States
(
north
of
Virginia
in
the
east
and
northern
California
in
the
west).
The
natural
range
of
C.
purpureum
is
thought
to
be
limited
to
temperate,
moist
zones.
Extensive
literature
searches
in
various
databases
found
no
reports
of
adverse
effects
on
birds,
mammals,
fish,
arthropods,
non­
arthropod
invertebrates
and
aquatic
plants.
Numerous
reports
of
adverse
effects
on
various
terrestrial
plants
were
found.

The
natural
host
range
of
C.
purpureum
includes
a
variety
of
terrestrial
plants,
particularly
deciduous
trees
in
which
it
is
a
pathogen,
gaining
entry
mostly
through
newly
created
wounds
and
causing
the
systemic
`
silverleaf'
disease.
Coniferous
trees
have
had
reported
cases
of
infection,
though
other
saprophytes
apparently
quickly
crowd
out
C.
purpureum
in
infected
tissues
(
Etheridge
and
Morin
1963).
Herbaceous
plants
are
reportedly
not
infected
by
C.
purpureum.
Disease
in
infected
plants
includes
occlusion
of
xylem
and
subsequent
water
stress
to
the
plant
with
a
variety
of
compounds
reportedly
produced
that
cause
or
contribute
to
disease
symptoms
(
Spiers
et
al.
1987),
including
extracellular
endo­
polygalacturonase
enzymes
(
Miyairi
et
al.
1977;
Miyairi
et
al.
1979),
and
sesquiterpene
compounds
such
as
torreyol,
sterpuric
acid,
sterepolide,
and
dihydrosterepolide
(
Strunz
et
al.
1997;
Ayer
et
al.
1981).
Fructification
and
replacement
by
secondary
colonizers
is
typically
reported
between
6
 
12
months
and
3
years.

In
a
recent
study,
Setliff
(
2002)
noted
the
potential
for
widespread
outbreak
of
silverleaf
disease
in
the
Betulaceae
and
Salicaceae
(
birch
and
alder)
following
timber
harvesting
or
storm
damage.
Setliff
also
noted
that
application
of
C.
purpureum
to
areas
often
pruned,
such
as
orchards,
should
be
avoided.
These
statements
are
largely
based
on
C.
purpureum's
ability
to
colonize
fresh
wounds
and
to
disseminate
in
the
environment
through
the
production
of
numerous
short­
lived
basidiospores
from
fertile
sporophores
following
significant
rainfall.
Thousands
of
naturally
released
basidiospores
per
cubic
metre
of
air
were
reported
by
Spiers
(
1985)
and
Dye
(
1974)
and
this
large
reservoir
of
basidiospores
provides
an
effective
strategy
for
early
arrival
on
potential
hosts.

Attempts
to
estimate
the
risk
of
infection
to
non­
target
terrestrial
plants
were
made
by
calculating
theoretical
spore
emissions
using
environmental
data
obtained
from
the
Netherlands
and
southern
Vancouver
Island,
British
Columbia
by
means
of
the
Gaussian
plume
model.
The
climate
of
Vancouver
Island,
with
environmental
conditions
particularly
suitable
for
fructification
and
sporulation,
represents
a
worst­
case
scenario
for
risk
to
non­
target
trees
in
North
America.
Using
these
data,
De
Jong
et
al.
(
1996)
estimated
that
the
added
number
of
basidiocarps
resulting
from
introduced
C.
purpureum
was
in
the
same
order
of
magnitude
as
naturally
occurring
levels,
or
lower.
The
presence
of
a
fresh
wound,
and
not
the
basidiospore
load,
is
the
main
determinant
of
a
non­
target
host
tree's
risk
of
infection.
As
well,
the
susceptibility
of
a
tree
is
dependent
on
its
health
status.
Healthy
host
trees
have
been
reported
to
successfully
fight
off
infection
by
physically
compartmentalizing
invading
C.
purpureum
(
Wall
1991).

Chontrol
Paste
is
to
be
applied
topically
as
a
paste
formulation,
so
exposure
of
terrestrial
and
aquatic
organisms
to
C.
purpureum
will
be
minimal
at
the
time
of
application.
Furthermore,
C.
purpureum
is
not
likely
to
spread
between
trees
through
the
root
system
and
environmental
fate
models
of
C.
purpureum
sporulation
and
spore
dispersal
suggest
that
the
additional
spore
density,
due
to
deployment
of
C.
purpureum
strain
PFC
2139
as
a
biological
control
agent
will
be
equal
in
magnitude
to,
or
less
than,
the
naturally
Chondrostereum
purpureum
strain
PFC
2139
September
20,
2004
Biopesticides
Registration
Action
Document
27
occurring
spore
density
from
resident
populations
of
C.
purpureum.
The
incremental
increase
in
spore
density
is
not
expected
to
increase
the
likelihood
of
adverse
effects
to
these
non­
target
organisms.

D.
Efficacy
Data
The
following
summary
of
efficacy
data
is
cited
from
Health
Canada,
Pest
Management
Regulatory
Agency
Product
Monograph
for
Chondrostereum
purpureum
(
PFC
2139)
Chontrol
Paste.
These
data
were
not
assessed
by
EPA.

1.
Effectiveness
a.
Intended
use
Chontrol
Paste
is
intended
for
use
on
cut
stumps
of
selected
deciduous
tree
species
including
red
alder
(
Alnus
rubra),
sitka
alder
(
Alnus
sinuata),
speckled
alder
(
Alnus
rugosa)
and
trembling
aspen
(
Populus
tremuloides)
in
rights­
of­
way,
and
forest
vegetation
management
situations.
An
application
of
Chontrol
Paste
is
designed
to
increase
the
efficiency
of
the
mechanical
cutting
operation
by
inhibiting
the
resprouting
and
regrowth
potential.

The
product
is
formulated
as
a
paste
which
is
spread
over
the
entire
surface
of
the
freshly
cut
stump
during
the
summer
or
fall
cutting
operation.
One
bottle
of
Chontrol
Paste
will
treat
approximately
200
cut
stumps
with
a
cut
surface
diameter
of
2
to
6
cm
(
approximately
5.0g
per
stump,
or
about
5,000
CFU
per
stump).
Successful
treatment
of
cut
stumps
with
Chontrol
Paste
should
result
in
reduced
resprouting
and
regrowth
thereby
minimizing
the
need
for
subsequent
cutting
and
allowing
for
the
establishment
of
more
desirable
shrub
species
in
rights­
of­
way
and
forest
vegetation
management
situations.

b.
Mode
of
action
Chondrostereum
purpureum
is
a
basidiomycete
fungus
belonging
to
the
Aphyllophorales
order
of
the
Corticiaceae
family.
Chondrostereum
purpureum
PFC
2139
was
isolated
from
a
canker
on
red
alder
near
Duncan,
British
Columbia.
The
fungus
is
not
host
specific
and
has
a
wide
host
range
with
a
preference
for
broad­
leaved
trees.
Chondrostereum
purpureum
invades
its
tree
host
through
wounds
in
the
xylem
and
causes
mortality
of
infected
trees
only
if
they
are
severely
stressed
(
e.
g.
tree
stems
girdled
or
cut).
The
pathogenicity
of
Chondrostereum
purpureum
is
expressed
as
silver
leaf
symptoms
of
some
trees
and
vascular
discoloration
and
necrosis
with
resulting
stem
cankers.
This
species
is
a
pioneer
pathogen,
rarely
surviving
more
than
three
years,
and
is
replaced
by
other
decay
organisms.

c.
Nature
of
pest
problem
Much
of
the
vegetation
that
requires
control
in
both
forestry
and
rights­
of­
way
management
consists
of
deciduous
hardwoods
trees
such
as
alders,
(
Alnus
spp.),
birches
(
Betula
spp.),
maples
(
Acer
spp.)
and
poplars
(
Populus
spp.).
These
fast
growing
species
suppress
the
more
economically
desirable
softwood
species
that
are
the
foundation
of
most
lumber
and
pulpwood
industries
(
MacLean
and
Morgan
1982,
Haeuschler
and
Coates
1986
and
Smith
1988).
Chondrostereum
purpureum
strain
PFC
2139
September
20,
2004
Biopesticides
Registration
Action
Document
28
d.
Effectiveness
against
pest
i.
Isolate
selection
One
of
the
first
steps
toward
development
of
the
end
use
product
Chontrol
Paste
was
to
evaluate
several
isolates
of
the
fungus
Chondrostereum
purpureum
to
determine
which
of
the
isolates
demonstrated
optimum
virulence
to
identify
an
isolate
suitable
for
further
testing.

Two
research
trials
(
1
laboratory
study
and
1
greenhouse
study)
were
conducted
to
determine
the
virulence
of
several
isolates
of
Chondrostereum
purpureum
to
cause
infection
and
mortality
on
potential
hosts
and
host
tissues.

In
the
laboratory
study,
18
isolates
of
Chondrostereum
purpureum
were
inoculated
onto
tissue
cultures
of
red
alder
(
Alnus
rubra),
black
cottonwood
(
Populus
balsamifera)
and
thimbleberry
(
Rubus
parviflorus).
The
study
results
indicated
that
there
was
a
significant
difference
in
the
virulence
of
Chondrostereum
purpureum
among
the
isolates.
The
study
also
reported
a
significant
difference
in
the
virulence
of
the
fungus
to
woody
tissues.

A
greenhouse
study
was
conducted
over
a
one
year
period
to
evaluate
the
virulence
of
several
isolates
of
Chondrostereum
purpureum
to
cause
infection
and
mortality
on
black
cottonwood
and
red
alder
seedlings.
Ten
isolates
of
Chondrostereum
purpureum
were
inoculated
onto
black
cottonwood
seedlings,
while
12
isolates
of
Chondrostereum
purpureum
were
inoculated
onto
red
alder
seedlings.
One
year
after
inoculation,
the
study
reported
a
significant
difference
in
the
virulence
among
the
Chondrostereum
purpureum
isolates
tested.
The
results
also
demonstrated
that
there
was
a
significant
difference
in
the
ability
of
Chondrostereum
purpureum
to
infect
and
cause
mortality
between
the
seedlings
tested,
with
black
cottonwood
being
a
more
challenging
species
compared
to
red
alder.

The
results
of
the
isolate
selection
trials
demonstrate
the
ability
of
Chondrostereum
purpureum
to
infect
various
broadleaf
tree
species
and
cause
a
degree
of
mortality
that
varies
between
tree
species.
As
such,
these
trials
are
supportive
of
the
proposed
use
pattern.

ii.
Efficacy
on
selected
species
Red
alder
(
Alnus
rubra)

Red
alder
is
exclusively
found
along
the
coastal
region
of
British
Columbia
(
B.
C.)
and
along
the
coastal
region
of
the
northwestern
U.
S.
states
(
Canadian
Biodiversity
web
site
2003,
Hosie
1979,
Little
1971).
One
shade
house
trial
and
3
operational
trials
reported
the
performance
of
Chontrol
Paste
on
red
alder.

The
greenhouse
trial
was
conducted
over
1
year
(
1995
­
1996)
near
Victoria,
B.
C.
in
which
12
one­
year­
old
red
alder
stumps
were
inoculated
with
one
of
twelve
isolates
of
Chondrostereum
purpureum.
Measurements
were
recorded
on
a
monthly
basis
which
included
the
number
of
living
shoots,
stem
dieback,
and
percent
mortality.
One
year
after
inoculation,
all
Chondrostereum
purpureum
isolates
provided
a
positive
infection,
though
significant
differences
were
noted
among
the
virulence
of
isolates.
Of
the
twelve
isolates
tested,
three
isolates
(
2128u,
2139
and
3x­
8u)
provided
a
more
consistent
level
of
red
alder
growth
response.
Overall,
the
Chondrostereum
purpureum
strain
PFC
2139
September
20,
2004
Biopesticides
Registration
Action
Document
29
results
do
support
the
infectivity
of
the
fungal
pathogen
and
the
differential
virulence
between
isolates,
with
isolate
2139
performing
well.

Three
operational
trials
conducted
over
2
years
(
1
trial
in
1994
and
2
trials
in
1995)
reported
the
growth
response
parameters
such
as
percent
mortality
and
the
number
of
stems
per
stump
in
the
year
following
treatment
(
3
trials),
2
years
following
treatment
(
2
trials),
and
3
years
after
treatment
(
1
trial).

One
year
after
treatment,
Chontrol
Paste
provided
a
mean
of
94%
mortality
(
n=
3)
and
a
mean
of
2.7
sprouts
per
stump
(
n=
2),
while
the
cut
only
treatment
provided
a
mean
of
49%
mortality
(
n=
3)
and
a
mean
of
7.9
sprouts
per
stump
(
n=
2).

Two
years
after
treatment,
Chontrol
Paste
provided
a
mean
of
100%
mortality
(
n=
2)
and
a
mean
of
0
sprouts
per
stump
(
n=
1),
while
the
cut
only
treatment
provided
a
mean
of
50.7%
mortality
(
n=
2)
and
a
mean
of
11.3
sprouts
per
stump
(
n=
1).

Three
years
after
treatment,
Chontrol
Paste
provided
a
mean
of
100%
mortality
(
n=
1),
while
the
cut
only
treatment
provided
a
mean
of
15.4%
mortality
(
n=
1).

The
data
supports
a
claim
that
sprouting
or
regrowth
of
red
alder
is
inhibited
following
an
application
of
Chontrol
Paste.

Sitka
alder
(
Alnus
sinuata)

Sitka
alder
is
distributed
throughout
B.
C.
and
extends
its'
range
into
the
western
portion
of
Alberta
and
the
northwestern
U.
S.
states
(
Canadian
Biodiversity
web
site
2003,
Hosie
1979,
Little
1976).

One
operational
trial
was
conducted
over
2
years
(
1995
­
1997)
near
Ripperto
Creek,
B.
C.
in
which
sitka
alder
clumps
received
1
of
8
treatments
including
Chontrol
Paste,
Paste
blank,
cut
only,
and
a
stump
application
of
triclopyr.
One
year
after
treatment,
Chontrol
Paste
provided
a
mean
of
80%
mortality,
and
a
mean
of
1.8
sprouts
per
clump,
the
Paste
blank
treatment
provided
a
mean
of
4%
mortality,
and
a
mean
of
14.1
sprouts
per
clump,
the
cut
only
treatment
provided
a
mean
of
16%
mortality,
and
a
mean
of
10.2
sprouts
per
clump,
the
stump
application
of
triclopyr
provided
a
mean
of
100%
mortality,
and
a
mean
of
0
sprouts
per
clump.

Two
years
after
treatment,
Chontrol
Paste
provided
a
mean
of
88%
mortality,
and
a
mean
of
0.7
sprouts
per
clump,
the
Paste
blank
treatment
provided
a
mean
of
7.4%
mortality,
and
a
mean
of
16.4
sprouts
per
clump,
the
cut
only
treatment
provided
a
mean
of
11.2%
mortality,
and
a
mean
of
12.1
sprouts
per
clump,
the
stump
application
of
triclopyr
provided
a
mean
of
98.2%
mortality,
and
a
mean
of
0.1
sprouts
per
clump.

With
the
overlapping
and
exclusive
range
of
red
alder
and
sitka
alder
to
British
Columbia,
the
environmental
conditions,
such
as
temperature,
moisture,
and
light,
required
for
spore
germination
and
mycelium
growth
would
be
similar
for
both
alder
species.
It
is
therefore
reasonable
to
use
the
red
alder
data
to
support
the
claim
for
sitka
alder.

The
data
supports
a
claim
that
sprouting
or
regrowth
of
sitka
alder
is
inhibited
following
an
application
of
Chontrol
Paste.
Chondrostereum
purpureum
strain
PFC
2139
September
20,
2004
Biopesticides
Registration
Action
Document
30
Speckled
alder
(
Alnus
rugosa)

Speckled
alder
is
widely
distributed
across
Canada
with
the
exception
of
the
coastal
region
of
B.
C.
Its
range
also
extends
into
the
northern
U.
S.
states
which
surround
the
Great
Lakes,
and
throughout
the
New
England
States
(
Canadian
Biodiversity
web
site
2003,
Hosie
1979).

One
operational
field
trial
was
conducted
over
2
years
(
1995
­
1997)
near
Thessalon,
Ontario
in
which
speckled
alder
clumps
received
1
of
8
treatments
including
Chontrol
Paste,
Paste
blank,
cut
only,
and
a
stump
application
of
triclopyr.
One
year
after
treatment,
Chontrol
Paste
provided
a
mean
of
12%
mortality,
and
a
mean
of
8.9
sprouts
per
clump,
the
Paste
blank
treatment
provided
a
mean
of
0%
mortality,
and
a
mean
of
21.6
sprouts
per
clump,
the
cut
only
treatment
provided
a
mean
of
0%
mortality,
and
a
mean
of
21.4
sprouts
per
clump,
the
stump
application
of
triclopyr
provided
a
mean
of
94%
mortality,
and
a
mean
of
1.2
sprouts
per
clump.

Two
years
after
treatment,
Chontrol
Paste
provided
a
mean
of
26%
mortality,
and
a
mean
of
5.5
sprouts
per
clump,
the
Paste
blank
treatment
provided
a
mean
of
0%
mortality,
and
a
mean
of
16.0
sprouts
per
clump,
the
cut
only
treatment
provided
a
mean
of
0%
mortality,
and
a
mean
of
15.4
sprouts
per
clump,
the
stump
application
of
triclopyr
provided
a
mean
of
92%
mortality,
and
a
mean
of
1.1
sprouts
per
clump.

Insufficient
data
were
made
available,
considering
the
distribution
of
speckled
alder
throughout
Canada,
with
which
to
base
a
scientific
conclusion
as
to
the
performance
of
Chontrol
Paste
to
inhibition
of
resprouting
and
regrowth
of
speckled
alder
and
must
therefore
be
removed
from
the
product
label
in
Canada.

Trembling
aspen
(
Populus
tremuloides)

Trembling
aspen
is
widely
distributed
across
Canada
and
into
the
northern
U.
S.
states
(
Hosie
1979,
Little
1971).

Three
operational
trials
were
conducted
at
2
sites
in
B.
C.
and
1
site
in
Ontario
and
reported
trembling
aspen
growth
responses
following
an
application
of
Chontrol
Paste
1
or
2
years
after
treatment.

A
study
conducted
near
Chetwynd,
B.
C.
over
one
year
(
1996­
1997)
reported
that
Chontrol
Paste
provided
a
significant
treatment
effect
on
stump
mortality
and
stump
health
index
when
compared
to
the
blank
formulation
treatment
and
the
cut
only
treatments.
One
year
after
treatment,
Chontrol
Paste
provided
a
mean
of
37%
mortality,
the
Paste
blank
treatment
provided
a
mean
of
21%
mortality,
the
cut
only
treatment
provided
a
mean
of
15%
mortality,
and
the
stump
application
of
triclopyr
provided
a
mean
of
100%
mortality.
Based
on
the
data
provided,
Chontrol
Paste
performed
significantly
better
than
the
formulation
blank
and
the
cut
only
treatments.

A
two
year
study
(
1995­
1997)
conducted
northwest
of
Grand
Forks,
B.
C.
reported
that
Chontrol
Paste
provided
a
significant
treatment
effect
on
stump
mortality
when
compared
to
the
blank
formulation
treatment
and
the
cut
only
treatment.
Two
years
after
treatment,
Chontrol
Paste
provided
a
mean
of
84%
mortality
and
a
mean
of
2.2
sprouts
per
square
metre,
the
Paste
blank
treatment
provided
a
mean
of
14%
mortality
and
a
mean
of
3.4
sprouts
per
square
metre,
the
cut
only
treatment
provided
a
mean
of
31%
mortality
and
a
mean
of
4.2
sprouts
per
square
metre,
and
the
stump
application
of
triclopyr
provided
a
mean
of
97%
mortality
and
a
Chondrostereum
purpureum
strain
PFC
2139
September
20,
2004
Biopesticides
Registration
Action
Document
31
mean
of
0.4
sprouts
per
square
metre.
Based
on
the
data
provided,
Chontrol
Paste
performed
significantly
better
than
the
formulation
blank
and
the
cut
only
treatments
and
comparable
to
the
triclopyr
treatment.

A
two
year
study
(
1995­
1997)
conducted
north
of
Iron
Bridge,
Ontario
reported
that
Chontrol
Paste
caused
a
reduction
in
the
number
of
root
suckers
per
metre
(
0.05
root
suckers/
m2)
when
compared
to
the
Paste
blank
treatment
(
0.56
root
suckers/
m2)
and
the
cut
only
treatment
(
0.59
root
suckers/
m2).
However,
the
Chontrol
Paste
treatment
did
not
provide
a
reduction
in
the
number
of
stem
sprouts
per
square
metre,
the
stem
sprout
height
per
square
metre,
or
the
root
sucker
height
per
square
metre
when
compared
to
the
Paste
blank
treatment
and
the
cut
only
treatment.
Mortality
was
not
reported
in
this
study.

The
results
from
the
Ontario
trial
are
inconsistent
with
that
reported
in
the
2
B.
C.
trials.
There
is
concern
that
the
inconsistency
may
be
associated
with
the
virulence
of
the
fungal
isolate
PFC
2139,
which
was
isolated
from
a
canker
on
red
alder
near
Duncan,
B.
C.
As
Chondrostereum
purpureum
is
a
living
organism,
it
is
possible
that
the
virulence
of
PFC
2139
was
diminished
due
to
the
unfavourable
environmental
conditions
found
outside
of
its'
natural
B.
C.
habitat.
If
environmental
conditions
found
in
Ontario
contributed
to
the
diminished
virulence
of
Chontrol
Paste,
different
environmental
conditions
found
across
Canada
may
have
an
influence
on
the
performance
of
the
product
to
inhibit
the
sprouting
or
regrowth
of
trembling
aspen.

Insufficient
data
were
made
available
to
base
a
scientific
conclusion
as
to
the
performance
of
Chontrol
Paste
to
inhibition
of
resprouting
and
regrowth
of
trembling
aspen
and
must
therefore
be
removed
from
the
product
label
in
Canada.

2.
Phytotoxicity
to
target
plants
(
including
different
cultivars),
or
to
target
plant
products
Chondrostereum
purpureum
is
pathogenic
to
a
wide
variety
of
species
with
pathogenicity
expressed
as
sapwood
stain,
non­
girdling
cankers,
and
silver
leaf
disease,
but
is
seldom
lethal
unless
the
host
is
subjected
to
severe
stress
(
Bishop
1978,
Wall
1996).

In
the
summary
provided
concerning
the
environmental
fate
of
Chondrostereum
purpureum,
the
applicant
states
that
the
topical
application
of
mycelium
to
the
surface
of
cut
stems
would
pose
little
risk
to
nearby
vegetation
at
the
time
of
application.
Local
dispersion
of
Chondrostereum
purpureum
can
be
expected
through
airborne
basidiospores.
Since
this
fungus
requires
a
fresh
wound
to
enter
a
host,
susceptible
nontarget
vegetation
is
only
at
risk
following
pruning
or
other
activity
that
introduces
wounds
during
times
of
active
sporulation.

Polymorphisms
in
the
mitochondrial
DNA
restriction
patterns
were
used
to
assess
genetic
variation
in
the
Chondrostereum
purpureum
population.
The
distribution
of
DNA
types
suggests
that
gene
flow
has
occurred
across
the
entire
continent
of
North
America
with
little
variation
between
east
and
central
or
west
and
central
North
America,
but
higher
variation
between
east
and
west.
This
implies
that
central
North
America
acts
as
a
bridge
between
the
coastal
populations.

Two
field
trials
were
performed
to
establish
that
disease
symptoms
were
from
Chondrostereum
purpureum
specifically.
Diagnostic
molecular
genetic
markers
were
used
to
estimate
infection
frequency
following
a
treatment
with
Chondrostereum
purpureum
(
Becker
et
al.
1999)
The
two
trials
were
established
in
British
Columbia
on
sitka
alder
and
trembling
aspen
(
one
trial
each).
Results
indicated
that
the
specific
isolates
released
were
recovered
only
from
stumps
which
had
been
treated
with
the
isolates
in
question.
The
applicant
Chondrostereum
purpureum
strain
PFC
2139
September
20,
2004
Biopesticides
Registration
Action
Document
32
indicates
that
there
was
no
cross­
contamination
with
a
Paste
formulation
suggesting
that
this
method
of
application
of
Chondrostereum
purpureum
is
highly
target
specific.

Should
damage
to
the
desired
conifers
occur
during
a
release
operation,
the
only
active
source
of
inoculum
would
be
the
Chontrol
Paste
which
will
not
have
activity
unless
applied
directly
to
the
wound.
Increased
source
of
inoculum,
ie.
via
spore
release
from
infected
deciduous
stumps,
would
occur
subsequent
to
the
treatment
period
with
conifer
wounds
having
healed,
thereby
minimizing
the
likelihood
of
infection.

3.
Economics
The
harvest
of
commercial
softwoods
in
Canada
equals
or
exceeds
the
annual
allowable
cut
of
about
170,000,000
m3
(
Canadian
Council
of
Forest
Ministers
1993).
According
to
the
applicant,
productivity
of
commercial
forest
lands
needs
to
be
increased
through
more
intensive
management
in
order
for
industry
to
maintain
its
present
level.
Currently,
over
700,000,000
tree
seedlings
are
planted
annually
in
Canada
and
the
total
cost
for
silviculture
exceeds
$
800,000,000
(
Canadian
Council
of
Forest
Ministers
1993).
According
to
the
applicant,
this
level
of
activity
is
likely
to
increase,
requiring
environmentally
friendly
options
for
vegetation
management.
Further,
the
applicant
anticipates
that
the
use
of
Chontrol
Paste
will
increase
the
efficacy
of
manual
or
mechanical
control
of
hardwoods
and
reduce
the
reliance
on
chemical
control.

4.
Sustainability
It
is
expected
that
the
use
of
Chontrol
Paste
will
result
in
a
reduction
in
conventional
herbicide
use
in
the
proposed
use
pattern
of
rights­
of­
way
and
forest
management
settings.
The
frequency
of
mechanical
brush
control
operations
should
also
be
reduced
with
the
use
of
Chontrol
Paste
due
to
the
increased
control
of
weedy
deciduous
species,
thereby
prolonging
the
time
period
between
mechanical
cutting
operations.
Chontrol
Paste
represents
a
non­
chemical,
biological
control
alternative
for
situations
in
which
chemical
treatment
is
no
longer
acceptable.

a.
Survey
of
alternatives
i.
Nonchemical
control
practices
Mechanical
clearing
techniques
are
commonly
used
for
control
of
weedy
deciduous
species
in
utility
rights­
ofway
and
conifer
release
management
situations.
The
frequency
of
operations
depends
on
the
weedy
species
present
at
the
site
and
their
associated
resprouting
tendency.
Accordingly,
sites
inhabited
by
species
with
a
prolific
tendency
to
sprout
require
more
frequent
cutting
activities.
Chondrostereum
purpureum
strain
PFC
2139
September
20,
2004
Biopesticides
Registration
Action
Document
33
ii.
Chemical
control
practices
Alternative
herbicides
for
brush
control
in
rights­
of­
way
and
conifer
release:

Technical
Grade
Active
Ingredient
End­
Use
Products
Herbicide
Classification
Application
Rate
(
g
a.
i./
ha)
Group
Mode
of
Action
Glyphosate
Ezject
Herbicide
Capsules
9
Inhibitor
of
5­
enolpyruvylshikimate­
3­
phosphate
(
EPSP)
synthase
0.15
g
a.
e
per
5
cm
tree
stump
diameter
Triclopyr
Garlon
4
4
Synthetic
auxins
1.9
to
3.8
kg
a.
i./
ha
Picloram
+
2,4­
D
Tordon
101
4
Synthetic
auxins
5.5
to
7.6
kg
a.
i./
ha
for
broadcast
application;
1:
1
ratio
with
water
for
cut
stump
treatment
Hexazinone
Velpar
5
Inhibitor
of
photosynthesis
at
photosystem
II
Site
A
4
to
8
kg
a.
i./
ha
b.
Compatibility
with
current
management
practices
including
integrated
pest
management
The
common
management
practices
for
vegetation
control
in
rights­
of­
way
and
conifer
release
management
rely
largely
on
conventional
herbicide
use.
In
certain
settings
however,
the
use
of
herbicides
is
no
longer
acceptable,
so
brush
saw
cutting
offers
the
only
viable
option
for
weedy
brush
control.
As
such,
Chontrol
Paste
is
compatible
with
the
current
management
systems
and
in
fact,
could
become
a
vital
part
of
integrated
vegetative
management
in
rights­
of­
way
as
well
as
forestry
managment.

c.
Contribution
to
risk
reduction
The
use
of
Chontrol
Paste
offers
an
alternative
to
traditional
chemicals
by
augmenting
the
efficacy
of
a
brush
cut
operation
and
reducing
the
number
of
follow
up
cutting
operations
required.
As
such,
this
product
may
contribute
to
reduced
chemical
use
in
rights­
of­
way
and
forest
management
settings.

d.
Information
on
the
occurrence
or
possible
occurrence
of
the
development
of
resistance
Based
on
the
mode
of
action
of
Chontrol
Paste,
the
development
of
resistance
is
unlikely.
The
use
of
Chontrol
Paste
in
conjunction
with
conventional
herbicides
may
mitigate,
in
part,
the
development
of
herbicide
resistance
in
hardwoods,
as
well
as
minimize
the
potential
for
resistance
to
Chondrostereum
purpureum.
Chondrostereum
purpureum
strain
PFC
2139
September
20,
2004
Biopesticides
Registration
Action
Document
34
5.
Conclusions
Adequate
efficacy
data
were
provided
to
support
the
use
of
Chontrol
Paste
in
rights­
of­
way
and
forest
vegetation
management,
as
proposed
on
the
product
label,
for
the
inhibition
of
resprouting
and
regrowth
from
cut
stumps
of
red
alder
and
sitka
alder.
Insufficient
data
were
made
available
to
base
a
scientific
conclusion
as
to
the
performance
of
Chontrol
Paste
to
inhibition
of
resprouting
and
regrowth
of
speckled
alder
and
trembling
aspen
and
must
therefore
be
removed
from
the
Canadian
product
label.
Adequate
data
were
provided
to
address
the
issue
of
potential
adverse
effects
to
conifer
species
with
the
use
of
Chontrol
Paste
as
proposed
in
rights­
of­
way
and
forest
vegetation
management
situations.

IV.
RISK
MANAGEMENT
AND
RE/
REGISTRATION
DECISION
A.
Determination
of
Eligibility
of
Registration
Section
3(
c)(
5)
of
FIFRA
provides
for
the
registration
of
new
active
ingredients
if
it
is
determined
that
(
A)
its
composition
is
such
as
to
warrant
the
proposed
claims
for
it;
(
B)
its
labeling
and
other
materials
required
to
be
submitted
comply
with
the
requirements
of
FIFRA;
(
C)
it
will
perform
its
intended
function
without
unreasonable
adverse
effects
on
the
environment;
and
(
D)
when
used
in
accordance
with
widespread
and
commonly
recognized
practice,
it
will
not
generally
cause
unreasonable
adverse
effects
on
the
environment.

To
satisfy
criterion
"
A"
above,
Chondrostereum
purpureum
strain
PFC
2139
has
well
known
properties.
The
EPA
has
no
knowledge
that
would
contradict
the
claims
made
on
the
label
of
this
product.
Criterion
"
B"
is
satisfied
by
the
current
label
and
by
the
data
presented
in
this
document.
It
is
believed
that
this
new
pesticidal
active
ingredient
will
not
cause
any
unreasonable
adverse
effects,
is
a
broad
spectrum
microbial
fungicide,
and
does
provide
protection
as
claimed
satisfying
criterion
"
C".
Criterion
"
D"
is
satisfied
in
that
Chondrostereum
purpureum
strain
PFC
2139
is
not
expected
to
cause
unreasonable
adverse
effects
when
used
according
to
label
instructions.

Therefore,
Chondrostereum
purpureum
strain
PFC
2139
is
eligible
for
registration.
The
eligible
uses
are
listed
in
the
Section
II,
B.
Use
Profile.
There
are
no
ineligible
uses
for
Chondrostereum
purpureum
strain
PFC
2139.

B.
Regulatory
Position
1.
Unconditional/
Conditional
Registration
With
only
one
exception,
the
data
requirements
are
fulfilled
for
registration
of
products
that
contain
Chondrostereum
purpureum
strain
PFC
2139
as
the
sole
active
ingredient.
EPA
is
issuing
a
Conditional
Registration
for
the
Manufacturing
Use
Product
(
CP­
PFC
2139
and
its
End­
Use
Product,
Chontrol
Paste).
The
conditions
of
registration
are
spelled
out
in
the
notice
of
registration:
replacement
of
the
acute
pulmonary
infectivity
and
toxicity
study
or
alternatively,
submission
of
an
acute
intraperitoneal
injection
infectivity
study
to
satisfactorily
address
the
infectivity
potential
of
Chondrostereum
purpureum
strain
PFC
2139.
Chondrostereum
purpureum
strain
PFC
2139
September
20,
2004
Biopesticides
Registration
Action
Document
35
2.
Tolerances
for
Food
Uses
and
/
Or
Exemptions
Chontrol
Paste
is
not
to
be
applied
to
food
or
feed.
Therefore,
the
establishment
of
a
tolerance
is
not
required
for
C.
purpureum
strain
PFC
2139.

3.
CODEX
Harmonization
There
are
no
CODEX
values
for
Chondrostereum
purpureum
strain
PFC
2139
.

4.
Risk
Mitigation
There
is
minimal
or
negligible
potential
hazard
to
humans
and
non­
target
organisms
(
plants,
insects,
aquatic
freshwater
estuarine
and
marine
animals
and
wildlife),
and
to
ground
and
surface
water
contamination
through
the
proposed
use
of
products
containing
Chondrostereum
purpureum
strain
PFC
2139
as
discussed
in
this
document
as
long
as
label
directions
are
followed.
No
further
mitigation
measures
are
required
at
this
time
beyond
the
appropriate
PPE
required
for
pesticide
applicators
and
other
handlers.
These
include
long
sleeved
shirt,
long
pants,
shoes
and
socks
plus
gloves
and
respirator.
The
product
labels
will
also
include
appropriate
Environmental
Hazards
text
to
mitigate
any
potential
risk.

5.
Endangered
Species
Statement
No
adverse
effects
are
expected
to
any
of
the
deciduous
woody­
plant
species
listed
by
the
U.
S.
Fish
and
Wildlife
Service.

Given
the
specificity
of
this
microbial
pesticide,
the
application
method,
the
intended
use
pattern,
and
Chondrostereum
purpureum's
innate
dependency
on
fresh
wounding
of
trees
to
be
an
effective
herbicide,
the
EPA
has
determined
that
this
action
will
have
no
effect
on
currently
listed
endangered
and
threatened
species.
These
findings
are
supported
by
the
results
of
toxicity
and
exposure
data
from
the
public
scientific
literature
and
from
the
data
submitted
by
the
applicant.

C.
Labeling
Rational
1.
Human
Health
Hazard
(
WPS
and
non­
WPS)

Chondrostereum
purpureum
strain
PFC
2139
products
with
commercial
use
sites
are
subject
to
the
Worker
Protection
Standard.
Because
of
the
low
toxicity
of
Chondrostereum
purpureum
strain
PFC
2139,
the
Re­
Entry
Interval
for
uses
within
the
scope
of
WPS
is
4
hours.
Precautionary
statements
and
personal
protective
equipment
as
specified
below
are
required
based
on
the
acute
toxicity
categories
of
this
organism.

2.
Environmental
Hazard
Precautionary
labeling
is
required
as
indicated
below
in
section
VI,
B.
Chondrostereum
purpureum
strain
PFC
2139
September
20,
2004
Biopesticides
Registration
Action
Document
36
V.
PUBLIC
INTEREST
FINDING
The
Agency
believes
use
of
Chondrostereum
purpureum
strain
PFC
2139
under
this
conditional
registration
would
be
in
the
public
interest.
The
criteria
for
Agency
evaluation
of
public
interest
findings
are
outlined
in
51
FR
No.
43,
Wednesday
March
5,
1986.
Under
part
IV.
A.,
the
proposed
product
may
qualify
for
an
automatic
presumptive
finding
that
the
proposed
conditional
registration
is
in
the
public
interest,
if
it
is
for
a
minor
use,
is
a
unique
replacement
for
pesticides
of
concern,
or
is
for
use
against
a
public
health
pest.

Although
forestry
use
is
not
a
minor
use,
the
proposed
uses
of
Chondrostereum
purpureum
strain
PFC
2139
is
a
minor
use
in
a
non­
minor
crop/
site.
Currently,
there
is
no
biopesticide
registered
to
inhibit
sprouting
and
regrowth
in
cut
stumps
of
certain
deciduous
tree
species
in
rights­
of­
way
and
forest
situations.
The
registration
of
Chondrostereum
purpureum
strain
PFC
2139
will
fulfil
a
unique
and
essential
user
need
in
forest
management.
The
proposed
microbial
pesticidal
active
ingredient
is
indigenous
to
North
America.
It
is
much
less
toxic
to
man
or
the
environment
and
represents
reduced
exposure
to
applicators
than
registered
alternatives
currently
in
use
within
the
forest
management
industry.
This
new
microbial
herbicide
will
actually
displace
use
of
other
conventional
chemical
herbicides
mentioned
above
in
section
III.
D.
4.
a.
This
new
microbial
herbicide
presents
advantageous
environmental
fate
characteristics
and
properties
as
compared
to
the
registered
alternatives.
Furthermore,
no
adverse
effects
have
been
reported
by
researchers
who
have
been
engaged
in
research
trials
with
this
active
ingredient.

Based
on
these
rationales,
the
Agency
has
determined
that
Chondrostereum
purpureum
strain
PFC
2139
is
likely
to
provide
a
cost
effective
biocontrol
herbicide
agent
for
inhibition
of
sprouting
and
regrowth
in
cut
stumps
of
certain
deciduous
tree
species,
and
availability
of
this
new
biopesticide
to
foresters
is
in
the
public
interest.

VI.
ACTIONS
REQUIRED
BY
REGISTRANTS
Reports
of
incidents
of
adverse
effects
to
humans
or
domestic
animals
are
required
under
FIFRA,
Section
6(
a)(
2)
and
incidents
of
hypersensitivity
under
40CFR158.690(
c)
and
guideline
reference
number
152­
16.
There
are
no
data
requirements,
label
changes
and
other
responses
necessary
for
the
reregistration
of
the
end­
use
product
since
the
product
is
being
registered
after
November
1984
and
is,
therefore,
not
subject
to
reregistration.
For
the
same
reason,
there
are
also
no
existing
stocks
provisions
at
this
time.
Before
releasing
these
products
for
shipment,
the
registrant
is
required
to
provide
appropriate
labels
and
other
Agency
requirements
as
discussed
in
this
document.

In
connection
with
the
Conditional
Registration
of
Chondrostereum
purpureum
strain
PFC
2139
products
mentioned
above,
replacement
of
the
acute
pulmonary
infectivity
and
toxicity
study
or
alternatively
submission
of
an
acute
intraperitoneal
injection
infectivity
study
to
satisfactorily
address
the
infectivity
potential
of
Chondrostereum
purpureum
strain
PFC
2139
is
required.

A.
Precautionary
Labeling
Chondrostereum
purpureum
strain
PFC
2139
products
must
state
the
following
under
the
heading
"
Precautionary
Statements":
Chondrostereum
purpureum
strain
PFC
2139
September
20,
2004
Biopesticides
Registration
Action
Document
37
Personal
Protective
Equipment
required
for
Applicators
and
other
handlers:

Long
sleeved
shirt
and
long
pants.
Waterproof
gloves.
Shoes
plus
socks.
A
NIOSH
approved
respirator
with
any
N,
P,
R,
or
HE
filter.

WPS
labels
must
state
the
following
under
the
heading
"
User
Safety
Recommendations"

Users
should
wash
hands
before
eating,
drinking,
chewing
gum,
using
tobacco,
or
using
the
toilet.

Users
should
remove
clothing
immediately
if
pesticide
gets
inside.
Then
wash
thoroughly
and
put
on
clean
clothing.

Users
should
remove
PPE
immediately
after
handling
this
product.
If
gloves
are
worn,
wash
the
outside
of
gloves
before
removing.
As
soon
as
possible,
wash
thoroughly
and
change
into
clean
clothing.

B.
Environmental
Hazards
Labeling
Provided
the
following
statement
is
placed
into
the
environmental
hazards
statement,
the
risk
of
Chondrostereum
purpureum
strain
PFC
2139
is
minimal
to
nonexistent
to
non­
target
organisms
including
endangered
species.

1.
End­
Use
Product
Environmental
Hazards
Labeling
"
Do
not
apply
directly
to
water,
or
to
areas
where
surface
water
is
present
or
to
intertidal
areas
below
the
mean
high
water
mark.
Do
not
contaminate
water
by
cleaning
of
equipment
or
disposal
of
equipment
washwaters.
"

2.
Manufacturing­
Use
Product
Environmental
Hazards
Labeling
"
Do
not
discharge
effluent
containing
this
product
into
lakes,
streams,
ponds,
estuaries,
oceans,
or
public
water
unless
this
product
is
specifically
identified
and
addressed
in
an
NPDES
permit.
Do
not
discharge
effluent
containing
this
product
to
sewer
systems
without
previously
notifying
the
sewage
treatment
plant
authority.
For
guidance,
contact
your
State
Water
Board
or
Regional
Office
of
the
EPA."

3.
Application
Rate
It
is
the
EPA's
position
that
the
labeling
for
the
pesticide
products
containing
Chondrostereum
purpureum
strain
PFC
2139
as
the
active
ingredient
complies
with
the
current
pesticide
labeling
requirements.
EPA
has
not
required
a
maximum
number
of
applications
per
season
for
this
active
ingredient.
Chondrostereum
purpureum
strain
PFC
2139
September
20,
2004
Biopesticides
Registration
Action
Document
38
C.
Other
Labeling
The
attached
label
conforms
with
the
labeling
requirements
for
Chondrostereum
purpureum
strain
PFC
2139
.
Some
of
the
essential
label
requirements
are
highlighted
below.

Signal
word
is
"
Caution,"
based
on
acute
dermal
toxicity/
pathogenicity
toxicity
category
III.
In
addition,
the
product
shall
contain
the
following
information:
­
Product
Name
­
Ingredient
Statement
­
EPA
Registration
Number
­
"
Keep
Out
of
Reach
of
Children"
statement
­
Signal
Word
(
CAUTION)
­
First
Aid
Statement
­
Personal
Protective
Equipment
(
PPE)
­
Environmental
Hazard
Statement
­
Storage
and
Disposal
Statement
­
Agricultural
Use
Requirements
­
Directions
for
Use
VII.
BIBLIOGRAPHY
Citations
Considered
to
be
part
of
the
Data
Base
Supporting
the
Registration
of
Chondrostereum
purpureum
strain
PFC
2139:

MRID
Citation
45493300
Mycologic,
Inc.
(
2001)
Submission
of
Product
Chemistry,
Efficacy,
Toxicity,
and
Environmental
Fate
Data
in
Support
of
the
Application
for
Registration
of
Chontrol.
Transmittal
of
4
Studies.

45493301
Bastide,
P.
(
2001)
Chondrostereum
purpureum
Isolate
PFC
2139
(
Comprehensive
Data
Summaries):
Lab
Project
Number:
94B.
Unpublished
study
prepared
by
MycoLogic,
Inc.
33
p.

45493302
Bastide,
P.
(
2001)
Chondrostereum
purpureum
Isolate
PFC
2139
Product
Identity
and
Disclosure
of
Ingredients,
Manufacturing
Process
and
Discussion
on
the
Formation
of
Unintentional
Ingredients,
Analysis
of
Samples,
Certification
of
Ingredient
Limits,
Analytical
Methods
for
Certified
Limits
and
Physical
and
Chemical
Properties:
Lab
Project
Number:
94B.
Unpublished
study
prepared
by
MycoLogic,
Inc.
714
p.
{
OPPTS
885.1000,
885.1100,
885.1300,
885.1400,
885.1500,
885.1600}

45493303
Harrington,
K.
(
1999)
Acute
Toxicity/
Limit
Testing
of
Chondrostereum
purpureum
Following
Acute
Oral
Challenge
in
Rats:
Lab
Project
Number:
L08725
SN2.
Unpublished
study
prepared
by
IIT
Research
Institute.
30
p.
{
OPPTS
870.1100}
Chondrostereum
purpureum
strain
PFC
2139
September
20,
2004
Biopesticides
Registration
Action
Document
39
45493304
Bastide,
P.
(
2001)
Chondrostereum
purpureum
Isoloate
PFC
2139
Hypersensitivity
Incidents:
Lab
Project
Number:
94B.
Unpublished
study
prepared
by
Mycologic,
Inc.
5
p.
{
OPPTS
885.3400}
45507100
Mycologic
Inc.
(
2001)
Submission
of
Toxicity
and
Efficacy
Data
in
Support
of
the
Application
for
Registration
of
Chontrol.
Transmittal
of
5
Studies.

45507101
Gingras,
B.
(
1998)
Sensitivity
of
Detection
of
Chondrostereum
purpureum
for
Toxicity/
Pathogenicity
Testing
in
Rats:
Final
Report:
Lab
Project
Number:
L08725
SN1.
Unpublished
study
prepared
by
IIT
Research
Institute.
32
p.
{
OPPTS
885.001,
885.3100,
885.3150}

45507102
Gingras,
B.
(
1999)
Toxicity/
Pathogenicity
Testing
of
Chondrostereum
purpureum
Following
Acute
Intratracheal
Challenge
in
Rats:
Final
Report:
Lab
Project
Number:
L08725
SN3.
Unpublished
study
prepared
by
IIT
Research
Institute.
95
p.
{
OPPTS
885.3150}
45507103
Findlay,
J.
(
1998)
Acute
Dermal
Toxicity/
Pathogenicity
Study
of
Chondrostereum
purpureum
in
Rabbits:
Lab
Project
Number:
L08725SN4.
Unpublished
study
prepared
by
IIT
Research
Institute.
25
p.
{
OPPTS
885.3100}

45507104
Harder,
J.
(
2001)
Acute
Eye
Irritation
Study
of
the
Technical
Grade
Formulation
Containing
Viable
Mycelia
of
Chondrostereum
purpeum
in
Rabbits:
Lab
Project
Number:
1367
SN1.
Unpublished
study
prepared
by
IIT
Research
Institute.
25
p.
{
OPPTS
870.2400}

45507105
Biehn,
W.
(
2001)
Chondrostereum
purpeum
Isolate
PFC
2139
Product
Performance
Data:
Lab
Project
Number:
94B.
Unpublished
study
prepared
by
The
University
of
Victoria.
477
p.

46018300
Mycologic
Inc.
(
2003)
Submission
of
Product
Chemistry
and
Toxicity
Data
in
Support
of
the
Applications
for
Registration
of
CP­
PFC
2139
and
Chontrol
Paste.
Transmittal
of
3
Studies.

46018301
de
la
Batiste,
P.
(
2003)
Chondostereum
purpueum
(
sic)
Isolate
PCF
2139
Comprehensive
Data
Summaries:
Amendment
#
1
to
MRID
45493301.
Project
Number:
94B.
Unpublished
study
prepared
by
Mycologic,
Inc.
35
p.

46018302
de
la
Batiste,
P.
(
2003)
Toxicology
and
Pathology
Studies:
Amendment
1:
(
Chontrol).
Project
Number:
94B.
Unpublished
study
prepared
by
Mycologic
Inc.
20
p.

46018303
de
la
Batiste,
P.
(
2003)
Environmental
Toxicology
and
Non­
Target
Studies:
(
Cp­
PFC
2139).
Project
Number:
94B.
Unpublished
study
prepared
by
Mycologic
Inc.
130
p.

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