Document ID: EPA-HQ-OPP-2004-0305-0031
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2006-03-22T05:00Z

ECOLOGICAL
HAZARD
AND
ENVIRONMENTAL
RISK
ASSESSMENT
Poly(
hexamethlenebiguanide)
hydrochloride
(
PHMB)

CASE
3122
PC
CODE
111801
November
18,
2005
Kathryn
V.
Montague,
M.
S.
Antimicrobials
Division
Office
of
Pesticide
Programs
U.
S.
Environmental
Protection
Agency
1200
Pennsylvania
Avenue,
NW
Washington,
DC
20460
Table
of
Contents
1.
Ecological
Toxicity
Data
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1
a.
Toxicity
to
Terrestrial
Animals
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.1
1.
Birds,
Acute
and
Subacute
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1
2.
Mammals,
Acute
and
Chronic
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.2
b.
Toxicity
to
Aquatic
Animals
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4
1.
Freshwater
Fish,
Acute
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.4
2.
Freshwater
Invertebrates,
Acute
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.4
3.
Estuarine
and
Marine
Organisms,
Acute
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5
4.
Aquatic
Organisms,
Chronic
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.5
c.
Toxicity
to
Plants
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6
2.
Risk
Assessment
and
Risk
Characterization
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.6
a.
Environmental
Fate
Assessment
Summary
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.8
b.
Environmental
Exposure
Assessment
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c.
Environmental
Risk
Assessment
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.8
d.
Listed
Species
Considerations
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3.
References
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10
1
Ecological
Effects
Hazard
and
Environmental
Risk
Assessment
Poly(
hexamethlenebiguanide)
hydrochloride
(
PHMB)

PHMB
is
used
as
a
microbiocide
in
swimming
pools/
spas,
secondary
oil
recovery
(
label
prevents
marine/
estuarine
use),
industrial
processing
applications,
eating
establishments,
hospitals,
metalworking
fluids,
and
textiles.

1.
Ecological
Toxicity
Data
The
toxicity
endpoints
presented
below
are
based
on
the
results
of
PHMB
toxicity
studies
submitted
to
EPA
to
meet
the
Agency's
ecological
effects
data
requirements
for
the
uses
of
PHMB.
Additional
information
was
located
in
EPA/
ORD's
ECOTOX
database,
which
provides
summary
endpoints
from
the
open
scientific
literature
as
well
as
studies
submitted
to
the
Agency.
PHMB
technical
is
a
20%
aqueous
solution;
thus,
submitted
testing
was
all
conducted
with
20%
active
ingredient
(
ai).
Some
earlier
reviews
erroneously
reported
these
studies
as
being
conducted
for
the
end­
use
product
of
PHMB,
and
not
the
technical
grade
of
the
active
ingredient
(
TGAI).
This
has
been
corrected
where
necessary
to
ensure
that
data
requirements
are
not
listed
as
outstanding
for
the
TGAI.
Endpoint
values
in
the
tables
below
are
provided
for
the
20%
solution,
as
well
for
100%
active
ingredient.
Toxicity
classifications
are
similarly
reported
for
both
the
20%
solution
and
pure
ai
where
necessary.

a.
Toxicity
to
Terrestrial
Animals
(
1)
Birds,
Acute
and
Subacute
In
order
to
establish
the
toxicity
of
PHMB
to
avian
species,
the
Agency
required
an
acute
oral
toxicity
study
using
the
TGAI.
The
preferred
test
species
is
either
mallard
duck
(
a
waterfowl)
or
bobwhite
quail
(
an
upland
game
bird).
The
results
of
one
toxicity
study
are
provided
in
the
following
table
(
Table
1).

Table
1.
Acute
Oral
Toxicity
of
PHMB
to
Birds
Species
%
Active
Ingredient
(
ai)
Endpoint
(
mg/
kg)
Toxicity
Category
(
TGAI)
Satisfies
Guidelines/
Comments
Reference
Mallard
(
Anas
platyrhynchos)
20
LD50
>
2510
(>
502
mg
ai/
kg)
NOEL
=
2510
(
502
mg
ai/
kg)
Slightly
toxic
Yes
°
core
study
°
14­
day
test
duration
Fink
and
Beavers,
1979/
Burt,
1990
(
MRID#
27491/
93191001)
2
The
results
indicate
that
pure
PHMB
is
moderately
toxic
to
avian
species
on
an
acute
oral
basis.
The
20%
technical
solution
is
practically
non­
toxic
to
birds
on
an
acute
oral
basis.
The
study
is
acceptable
and
fulfills
guideline
requirements
(
71­
1/
OPPTS
850.2100).

A
subacute
dietary
study
using
the
TGAI
may
be
required
on
a
case­
by­
case
basis
depending
on
the
results
of
lower­
tier
ecological
studies
and
pertinent
environmental
fate
characteristics
in
order
to
establish
the
toxicity
of
a
chemical
to
avian
species.
This
testing
was
not
required
for
PHMB.
However,
two
studies
were
available
in
the
OPP
database.
Results
of
these
studies
are
provided
in
Table
2.

Table
2.
Subacute
Dietary
Toxicity
of
PHMB
to
Birds
Species
%
Active
Ingredient
(
ai)
Endpoint
(
ppm)
Toxicity
Category
Satisfies
Guidelines/
Comments
Reference
Bobwhite
quail
(
Colinus
virginianus)
20
LC50
>
5620
(>
1124
ppm
ai)
NOEC
5620
ppm
(
1124
ppm
ai)
Practically
nontoxic
(
TGAI)

Slightly
toxic
(
100%
ai)
Core
study
Beavers
and
Fink,
1979/
Burt,
M.
E.
1990.
(
MRID#
41382/
93191002)

Mallard
duck
(
Anas
platyrhynchos)
20
LC50
>
5620
(>
1124
ppm
ai)
NOEC
5620
(
1124
ppm
ai)
Practically
nontoxic
(
TGAI)

Slightly
toxic
(
100%
ai)
Core
study
Beavers
and
Fink,
1979/
Burt,
M.
E.
1990.
(
MRID#
41382/
93191002)

The
results
indicate
that
pure
PHMB
is
slightly
toxic
to
avian
species
on
a
subacute
dietary
basis.
PHMB
technical
(
20%
active
ingredient)
is
practically
non­
toxic
to
birds
on
a
dietary
basis.
The
studies
are
acceptable
and
fulfill
guideline
requirements
(
71­
2/
OPPTS
850.2200).

(
2)
Mammals,
Acute
and
Chronic
Toxicity
Wild
mammal
testing
was
not
required
by
the
Agency.
In
most
cases,
rat
toxicity
values
obtained
from
studies
conducted
to
support
data
requirements
for
human
health
risk
assessments
substitute
for
wild
mammal
testing.
These
toxicity
values
are
reported
below
(
Table
3).
Further
information
on
the
mammalian
toxicology
of
PHMB
may
be
found
in
the
Toxicology
Disciplinary
Chapter
of
this
RED
document.
3
Table
3.
Acute
Toxicity
of
PHMB
to
Mammals
(
excerpted
from
Toxicology
Chapter)

Species
Test
Type
LD50
(
mg/
kg)
NOEL
(
mg/
kg/
day)
LOEL
(
mg/
kg/
day)
Reference
(
MRID)

Rat
Acute
oral
2747
­­
­­
00030330
Rat
Acute
dermal
LD50
>
5.0
­­
­­
00065124
Rat
90­
day
oral
No
mortality
at
levels
up
to
5000
ppm
­­
­­
MRID
00053460
Dog
90­
day
oral
The
NOAEL
for
this
90­
day
dog
feeding
study
appears
to
be
5500
ppm
(
low
dose).
The
high
dose
treatment
caused
a
lower
total
weight
gain
in
female
dogs
and
slight
hemosiderons
in
2
out
of
4
male
dogs.
MRID
00053461
Rabbit
Developmental
Maternal
NOAEL
=
20,
based
on
increased
mortality,
reduced
food
consumption,
and
clinical
toxicity
Maternal
LOAEL
40
42865901
Rat
Developmental
Based
on
the
increased
incidence
of
ribs
in
fetus,
the
Developmental
Toxicity
NOAEL
is
50
mg/
kg/
day.
Maternal
Toxicity
LOAEL
is
50
mg/
kg/
day,
based
on
reduced
body
weight
and
reduced
food
consumption.

Developmental
LOAEL
is
100
mg/
kg/
day
CTL/
P/
1262,
1976
cited
in
Report
#
003810,
1978.
Section
C­
11
Mammalian
acute
oral
and
dermal
toxicity
from
PHMB
is
low.
However,
it
is
a
dermal
and
eye
irritant.
Longer
term
(
subchronic)
studies
showed
no
systemic
effects
but
also
indicated
dermal
irritation.
There
was
no
quantitative
or
qualitative
evidence
of
increased
susceptibility
of
developmental
effects
following
in
utero
exposure
in
the
rat
or
rabbit.
Maternal
toxicity
was
reported
at
lower
dose
levels
than
the
developmental
toxicity
in
rats.
In
rabbits,
developmental
effects
were
observed
at
the
same
dose
level
as
the
maternal
effects.
4
b.
Toxicity
to
Aquatic
Animals
(
1)
Freshwater
Fish,
Acute
In
order
to
establish
the
acute
toxicity
of
PHMB
to
freshwater
fish,
the
Agency
required
a
freshwater
fish
toxicity
study
using
the
TGAI.
Data
are
generally
required
on
only
one
species
for
indoor
use
antimicrobial
pesticides.
The
preferred
test
species
are
rainbow
trout
(
a
coldwater
fish)
or
bluegill
sunfish
(
a
warmwater
fish).
Results
of
studies
are
presented
in
Table
4.

Table
4.
Acute
Toxicity
of
PHMB
to
Freshwater
Fish
Species
%
Active
Ingredient
(
ai)
Endpoints
(
ppm)
Toxicity
Category
Satisfies
Guidelines/
Comments
Reference
Rainbow
Trout
(
Oncorhynchus
mykiss)
20
96
hr.
LC50
=
13.5
(
2.7
ppm
ai)
Moderately
toxic
(
TGAI
&
100%
ai)
Supplemental
study
(
core
for
formulated
product)
°
flow­
through
system
°
96­
hr
test
duration
Hill
et
al.,
1975
ACC#
234289
MRID#
77928
Bluegill
sunfish
(
Lepomis
macrochirus)
20
96
hr.
LC50
=
0.62
(
0.46
­
0.83)
(
0.124
ppm
ai)
Highly
toxic
(
TGAI
&
100%
ai)
Supplemental
study
(
core
for
formulated
product)
Buccafusco
and
Sleight,
1977
ACC#
234289
MRID#
77929
Bluegill
sunfish
(
Lepomis
macrochirus)
20
96
hr.
LC50
=
0.91
(
0.182
ppm
ai)
Highly
toxic
(
TGAI
&
100%
ai)
Supplemental
Sousa,
J.
V.
1981
Rainbow
Trout
(
Oncorhynchus
mykiss)
20
96
hr.
LC50
=
0.02545
ppm
ai
(
0.017
­
0.033)
NOEC
=
0.0098
ppm
ai
Very
highly
toxic
(
TGAI
&
100%
ai)
Core
study
Penwell
and
Roberts,
1995
MRID#
43949001
The
results
indicate
that
PHMB,
as
well
as
the
technical
solution,
is
moderately
toxic
to
very
highly
acutely
toxic
to
freshwater
fish.
The
guideline
requirements
for
a
freshwater
fish
acute
study
have
been
fulfilled.

(
2)
Freshwater
Invertebrates,
Acute
The
Agency
required
a
freshwater
aquatic
invertebrate
toxicity
study
using
the
TGAI
to
establish
the
acute
toxicity
of
PHMB
to
freshwater
invertebrates.
The
preferred
test
species
is
Daphnia
magna.
Results
of
the
study
are
provided
in
the
following
table
(
Table
5).
5
Table
5.
Acute
Toxicity
of
PHMB
to
Freshwater
Invertebrates
Species
%
Active
Ingredient
(
ai)
Endpoints
(
ppm)
Toxicity
Category
Satisfies
Guidelines/
Comments
Reference
Waterflea
(
Daphnia
magna)
20
48­
hr.
EC50
=
0.18(
0.12
­
0.30)
(
0.036
ppm
ai)
NOEC
=
0.7
(
0.14
ppm
ai)
Highly
toxic
(
TGAI)

Very
highly
toxic
(
100%
ai)
°
Core
formulated
product
study
LeBlanc
and
Sleight,
1977
ACC#
234289
The
results
of
this
study
indicate
that
PHMB
is
highly
to
very
highly
toxic
to
freshwater
invertebrates.
The
guideline
requirement
has
been
fulfilled
(
850.1010/
72­
2).

(
3)
Estuarine
and
Marine
Organisms,
Acute
Acute
toxicity
testing
with
estuarine
and
marine
organisms
using
the
TGAI
is
required
when
the
end­
use
product
is
intended
for
direct
application
to
the
marine/
estuarine
environment
or
effluent
containing
the
active
ingredient
is
expected
to
reach
this
environment.
Although
PHMB
is
used
for
oil
recovery
applications,
the
labeling
prohibits
the
use
of
the
product
over
or
near
marine
and/
or
estuarine
oil
fields.
Therefore,
marine/
estuarine
acute
toxicity
testing
was
waived
for
PHMB.
A
search
of
the
ECOTOX
database
provided
several
endpoints
for
the
marine
polychaete,
Platynereis
dumerilii,
summarized
in
the
table
below:

Table
6.
Acute
Toxicity
of
PHMB
to
Marine/
Estuarine
Invertebrates
Species
%
Active
Ingredient
(
ai)
Endpoints
(
ppm)
Toxicity
Category
Reference
Polychaete
(
Platynereis
dumerilii)
Not
reported
24­
h
LC50
=
13.4
(
10.0
­
18.0)
48­
hr.
LC50
=
10.9
(
8.43
­
14.5)
48­
hr
NOEC
(
mort.)
=
5.6
Slightly
toxic
Hutchinson
et
al.,
1995
The
results
of
this
study
indicate
that
PHMB
is
slightly
toxic
to
the
marine
polychaete.

(
4)
Aquatic
Organisms,
Chronic
Chronic
toxicity
testing
(
Fish
early
life
stage,
850.1300/
72­
4a
and
aquatic
invertebrate
life
cycle,
850.1400/
72­
4b)
was
originally
required
for
PHMB
due
to
its
hydrolytic
stability
and
the
potential
for
continuous
exposure
from
oil
recovery
applications.
Chronic
fish
and
invertebrate
testing
for
microbiocides
were
waived
by
OPP,
however
(
1992
memorandum
from
OPP/
EFED
to
6
OPP/
SRRD),
and
deferred
to
the
Office
of
Water
under
their
NPDES
program
permitting
regulations.
Therefore,
no
chronic
testing
was
submitted
for
PHMB,
and
no
comparable
endpoints
were
found
in
the
ECOTOX
database.

c.
Toxicity
to
Plants
Plant
toxicity
testing
is
not
required
for
PHMB.
No
phytotoxicity
data
were
found
in
the
ECOTOX
database.

2.
Risk
Assessment
and
Characterization
Risk
assessment
integrates
the
results
of
the
exposure
and
ecotoxicity
data
to
evaluate
the
likelihood
of
adverse
ecological
effects.
One
method
of
integrating
the
results
of
exposure
and
ecotoxicity
data
is
called
the
quotient
method.
For
this
method,
risk
quotients
(
RQs)
are
calculated
by
dividing
exposure
estimates
by
ecotoxicity
values,
both
acute
and
chronic:

RQ
=
EXPOSURE/
TOXICITY
RQs
are
then
compared
to
OPP's
levels
of
concern
(
LOCs).
These
LOCs
are
criteria
used
by
OPP
to
indicate
potential
risk
to
nontarget
organisms
and
the
need
to
consider
regulatory
action.
The
criteria
indicate
that
a
pesticide
used
as
directed
has
the
potential
to
cause
adverse
effects
on
nontarget
organisms.
LOCs
currently
address
the
following
risk
presumption
categories:
(
1)
acute
high
­
potential
for
acute
risk
is
high,
and
regulatory
action
may
be
warranted
in
addition
to
restricted
use
classification;
(
2)
acute
restricted
use
­
the
potential
for
acute
risk
is
high,
but
this
may
be
mitigated
through
restricted
use
classification;
(
3)
acute
endangered
species
­
the
potential
for
acute
risk
to
endangered
species
is
high,
and
regulatory
action
may
be
warranted;
and
(
4)
chronic
risk
­
the
potential
for
chronic
risk
is
high,
and
regulatory
action
may
be
warranted.
Currently,
AD
does
not
perform
assessments
for
chronic
risk
to
plants,
acute
or
chronic
risks
to
nontarget
insects,
or
chronic
risk
from
granular/
bait
formulations
to
mammalian
or
avian
species.

The
ecotoxicity
test
values
(
i.
e.,
measurement
endpoints)
used
in
the
acute
and
chronic
risk
quotients
are
derived
from
the
results
of
required
studies.
Examples
of
ecotoxicity
values
derived
from
the
results
of
short­
term
laboratory
studies
that
assess
acute
effects
are:
(
1)
LC
50
(
fish
and
birds)
(
2)
LD
50
(
birds
and
mammals)
(
3)
EC
50
(
aquatic
plants
and
aquatic
invertebrates)
and
(
4)
EC
25
(
terrestrial
plants).
Examples
of
toxicity
test
effect
levels
derived
from
the
results
of
long­
term
laboratory
studies
that
assess
chronic
effects
are:
(
1)
LOEC
(
birds,
fish,
and
aquatic
invertebrates)
(
2)
NOEC
(
birds,
fish
and
aquatic
invertebrates)
and
(
3)
MATC
(
Maximum
Allowable
Toxic
Concentration)
(
fish
and
aquatic
invertebrates).
For
birds
and
mammals,
the
NOEC
value
is
used
as
the
ecotoxicity
test
value
in
assessing
chronic
effects.
Other
values
may
be
used
when
justified.
Generally,
the
MATC
(
defined
as
the
geometric
mean
of
the
NOEC
and
LOEC)
is
used
as
the
ecotoxicity
test
value
in
assessing
chronic
effects
to
fish
and
aquatic
invertebrates.
However,
the
NOEC
is
used
if
the
measurement
endpoint
is
production
of
offspring
or
survival.
7
Risk
presumptions,
along
with
the
corresponding
RQs
and
LOCs
are
tabulated
below.

Risk
Presumptions
for
Terrestrial
Animals
Risk
Presumption
RQ
LOC
Birds
and
Wild
Mammals
Acute
High
Risk
EEC1/
LC50
or
LD50/
sqft2
or
LD50/
day3
0.5
Acute
Restricted
Use
EEC/
LC50
or
LD50/
sqft
or
LD50/
day
(
or
LD50
<
50
mg/
kg)
0.2
Acute
Endangered
Species
EEC/
LC50
or
LD50/
sqft
or
LD50/
day
0.1
Chronic
Risk
EEC/
NOEC
1
1
abbreviation
for
Estimated
Environmental
Concentration
(
ppm)
on
avian/
mammalian
food
items
2
mg/
ft2
3
mg
of
toxicant
consumed/
day
LD50
*
wt.
of
bird
LD50
*
wt.
of
bird
Risk
Presumptions
for
Aquatic
Animals
Risk
Presumption
RQ
LOC
Acute
High
Risk
EEC1/
LC50
or
EC50
0.5
Acute
Restricted
Use
EEC/
LC50
or
EC50
0.1
Acute
Endangered
Species
EEC/
LC50
or
EC50
0.05
Chronic
Risk
EEC/
MATC
or
NOEC
1
1
EEC
=
(
ppm
or
ppb)
in
water
Risk
Presumptions
for
Plants
Risk
Presumption
RQ
LOC
Terrestrial
and
Semi­
Aquatic
Plants
Acute
High
Risk
EEC1/
EC25
1
Acute
Endangered
Species
EEC/
EC05
or
NOEC
1
Aquatic
Plants
Acute
High
Risk
EEC2/
EC50
1
Acute
Endangered
Species
EEC/
EC05
or
NOEC
1
1
EEC
=
lbs
ai/
A
2
EEC
=
(
ppb/
ppm)
in
water
8
a.
Environmental
Fate
Assessment
Summary
(
excerpted
from
the
Environmental
Fate
Science
Chapter,
of
this
RED
document)

PHMB
is
hydrolytically
stable
(
half­
life
>
30
days).
The
environmental
fate
science
chapter
states
that
no
other
environmental
fate
data
were
submitted
or
evaluated
for
this
RED.

b.
Environmental
Exposure
Assessment
Environmental
exposure
modeling
was
not
conducted
for
PHMB.
The
only
use
likely
to
result
in
significant
outdoor
exposure
is
the
oil
recovery
use.
However,
there
is
a
label
statement
prohibiting
use
over
or
near
marine/
estuarine
(
e.
g.,
offshore)
oil
fields.

c.
Environmental
Risk
Assessment
The
uses
of
PHMB
considered
in
this
RED
make
it
unlikely
that
any
appreciable
exposure
to
terrestrial
or
aquatic
organisms
would
occur.
The
high
toxicity
of
PHMB
to
freshwater
organisms
is
of
concern
in
the
event
of
a
spill
or
misuse
of
the
product.
Product
labeling
indicates
that
the
chemical
is
toxic
to
fish.
Facilities
using
PHMB
for
indoor
industrial
applications
are
required
to
have
NPDES
permits
before
discharging
effluents
into
receiving
waters.

d.
Listed
Species
Considerations
Section
7
of
the
Endangered
Species
Act,
16
U.
S.
C.
Section
1536(
a)(
2),
requires
all
federal
agencies
to
consult
with
the
National
Marine
Fisheries
Service
(
NMFS)
for
marine
and
anadromous
listed
species,
or
the
United
States
Fish
and
Wildlife
Services
(
FWS)
for
listed
wildlife
and
freshwater
organisms,
if
they
are
proposing
an
"
action"
that
may
affect
listed
species
or
their
designated
habitat.
Each
federal
agency
is
required
under
the
Act
to
insure
that
any
action
they
authorize,
fund,
or
carry
out
is
not
likely
to
jeopardize
the
continued
existence
of
a
listed
species
or
result
in
the
destruction
or
adverse
modification
of
designated
critical
habitat.
To
jeopardize
the
continued
existence
of
a
listed
species
means
"
to
engage
in
an
action
that
reasonably
would
be
expected,
directly
or
indirectly,
to
reduce
appreciably
the
likelihood
of
both
the
survival
and
recovery
of
a
listed
species
in
the
wild
by
reducing
the
reproduction,
numbers,
or
distribution
of
the
species."
50
C.
F.
R.
§
402.02.

To
facilitate
compliance
with
the
requirements
of
the
Endangered
Species
Act
subsection
(
a)(
2)
the
Environmental
Protection
Agency,
Office
of
Pesticide
Programs
has
established
procedures
to
evaluate
whether
a
proposed
registration
action
may
directly
or
indirectly
reduce
appreciably
the
likelihood
of
both
the
survival
and
recovery
of
a
listed
species
in
the
wild
by
reducing
the
reproduction,
numbers,
or
distribution
of
any
listed
species
(
U.
S.
EPA
2004).
After
the
Agency's
screening­
level
risk
assessment
is
performed,
if
any
of
the
Agency's
Listed
Species
LOC
Criteria
are
exceeded
for
either
direct
or
indirect
effects,
a
determination
is
made
to
identify
if
any
listed
or
candidate
species
may
co­
occur
in
the
area
of
the
proposed
pesticide
use.
If
determined
that
listed
or
candidate
species
may
be
present
in
the
proposed
use
areas,
further
biological
assessment
is
9
undertaken.
The
extent
to
which
listed
species
may
be
at
risk
then
determines
the
need
for
the
development
of
a
more
comprehensive
consultation
package
as
required
by
the
Endangered
Species
Act.

For
certain
use
categories,
the
Agency
assumes
there
will
be
minimal
environmental
exposure,
and
only
a
minimal
toxicity
data
set
is
required
(
Overview
of
the
Ecological
Risk
Assessment
Process
in
the
Office
of
Pesticide
Programs
U.
S.
Environmental
Protection
Agency
­
Endangered
and
Threatened
Species
Effects
Determinations,
1/
23/
04,
Appendix
A,
Section
IIB,
pg.
81).
Chemicals
in
these
categories
therefore
do
not
undergo
a
full
screening­
level
risk
assessment,
and
are
considered
to
fall
under
a
"
no
effect"
determination.
Due
to
the
low
likelihood
of
exposure
and
low
toxicity
of
PHMB,
the
Agency
expects
no
effects
to
listed
species
or
critical
habitat
and
therefore
makes
a
"
No
Effect"
determination
for
this
chemical.
10
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