Page
1
of
60
MEMORANDUM
DATE:
April
18,
2006
SUBJECT:
Orthophenylphenol
and
orthophenylphenol
salts:
AD
DRAFT
Risk
Assessment
for
the
Reregistration
Eligibility
Decision
(
RED)
Document.
Case
No.
2575,
PC
Codes:
064103,
064104,
064108,
064116.

FROM:
Tim
McMahon,
Ph.
D.,
Senior
Toxicologist
Najm
Shamim,
Ph.
D.,
Chemist
Kathryn
Montague,
Biologist
Talia
Milano,
Chemist
Cassi
Walls,
Ph.
D.,
Chemist
Bob
Quick,
Chemist
Antimicrobials
Division
(
7510C)

TO:
Rebecca
Miller,
Chemical
Review
Manager
Regulatory
Management
Branch
II
Antimicrobials
Division
(
7510C)

Attached
is
the
Preliminary
Risk
Assessment
for
orthophenylphenol
and
orthophenylphenol
salts
(
OPP/
NA­
OPP)
for
the
purpose
of
issuing
a
Reregistration
Eligibility
(
RED)
Decision.
The
disciplinary
science
chapters
and
other
supporting
documents
for
the
OPP/
NA­
OPP
RED
are
also
included
as
attachments
as
follows:

Toxicology
Science
Chapter
for
the
Reregistration
Eligibility
Decision
Document,
T.
McMahon,
October
2005
Revised
Occupational
and
Residential
Exposure
Chapter
for
Ortho­
phenylphenol
&
Ortho­
phenylphenol
Salts.
From
T.
Milano
and
C.
Walls,
Chemists,
to
Rebecca
Miller,
Chemical
Review
Manager.
April
2006.

Inert
Ingredient
Dietary
and
Non­
dietary
Risk
Assessments
for
O­
Phenylphenol
and
Salts
Reregistration
Eligibility
Document
(
RED).
From
T.
Milano
and
C.
Walls,
Chemists,
to
Rebecca
Miller,
Chemical
Review
Manager,
February
2006.

Ortho
Phenylphenol,
and
its
Sodium
and
Potassium
Salts.
Dietary
Exposure
Assessments
for
the
Reregistration
Eligibility
Decision
Memorandum
from
Bob
Quick,
Chemist.
to
Michelle
Centra,
August
2005
Product
Chemistry
of
Orthophenylphenol.
From
Najm
Shamim,
Ph.
D.
to
T.
McMahon,
Ph.
D.
,
April
2005
Science
Chapter
on:
Environmental
Fate
Studies
and
Environmental
Fate
Assessment
of
Orthophenylphenol.
From
Najm
Shamim,
Ph.
D.
Chemist,
to
Michelle
Centra,
September
2005,

Ecological
Hazard
and
Environmental
Risk
Assessment:
2­
Phenylphenol
and
Salts
From
Kathryn
V.
Montague,
M.
S.
,
December,
2005.
Page
2
of
60
Epidemiology
Assessment
based
on
Incident
Reports.
From
J.
Chen,
Ph.
D.
Toxicologist,
to
Tim
McMahon,
Ph.
D.
Toxicologist,
December
2005
Page
3
of
60
TABLE
OF
CONTENTS
1.0
EXECUTIVE
SUMMARY
2.0
PHYSICAL/
CHEMICAL
PROPERTIES
3.0
HAZARD
CHARACTERIZATION
3.1
Hazard
Profile
3.2
Dose­
Response
Assessment
3.3
FQPA
Considerations
3.4
Endocrine
Disruption
4.0
EXPOSURE
ASSESSMENT
AND
CHARACTERIZATION
4.1
Summary
of
Registered
Antimicrobial
Uses
4.1.1
Residential
Exposure
and
Risk
for
antimicrobial
uses
4.2
Dietary
Exposure
and
Risk
for
Antimicrobial
uses
4.2.1
Mushroom
houses
4.2.2
Poultry
uses
4.2.3
Greenhouse
uses
4.2.4
Polymer
and
Plastic
uses
4.2.5
Wood
and
wood
products
4.2.6
Paper
adhesive
uses
4.3
Dietary
Exposure
and
Risk
from
agricultural
uses
5.0
AGGREGATE
RISK
ASSESSMENT
AND
RISK
CHARACTERIZATION
5.1
Acute
and
Chronic
Dietary
Aggregate
Risk
5.2
Short­
and
Intermediate­
Term
Aggregate
Risk
6.0
CUMULATIVE
RISK
7.0
OCCUPATIONAL
EXPOSURE
7.1
Occupational
Postapplication
Exposure
7.1.1
Fogging
Exposure
7.1.2
Metalworking
fluid
use
7.2
Wood
Preservation
7.3
Summary
of
registered
conventional
(
agricultural)
uses
7.3.1
Occupational
Handler
Exposure
Scenarios
7.3.2
Occupational
Postapplication
exposure
and
risk
8.0
ENVIRONMENTAL
RISK
8.1
Ecological
Hazard
8.2
Environmental
fate
and
transport
8.3
Environmental
exposure
and
Risk
8.4
Endangered
Species
8.0
INCIDENT
REPORT
ASSESSMENT
9.1
OPP
Incident
Data
System
9.2
Poison
Control
Center
9.3
California
Data
1982­
2003
9.4
National
Telecommunication
Pesticide
Network
9.5
Hazardous
Substances
Data
Bank
9.6
Conclusions
10.0
REFERENCES
4
14
16
16
18
20
21
21
21
23
30
32
32
33
33
33
33
34
36
37
38
40
41
42
42
42
43
44
44
46
47
47
49
50
50
51
51
51
52
52
52
52
53
54
Page
4
of
60
Executive
Summary
Orthophenylphenol
(
hence
forth
2­
phenylphenol
or
OPP)
is
a
white
flaky
crystal
and
is
sparingly
soluble
in
water
but
soluble
in
alcohols
and
ethers.
However,
its
sodium
and
potassium
salts
are
highly
water
soluble.
Due
to
the
close
chemical
similarities
between
OPP
and
its
sodium
and
potassium
salts
(
NA­
OPP
and
K­
OPP),
the
hazard
characterization
is
a
composite
of
the
three
chemicals.
Currently,
there
are
124
active
registrations
for
2­
phenylphenol
and
salts.
Of
these
124,
seven
are
manufacturing
use/
technical
grade
active
ingredient
(
MUP/
TGAI)
products.

OPP
is
a
bacteriostat,
microbiostat,
nematicide,
fumigant,
and
bactericide
chemical.
As
a
fungicide,
tolerances
have
been
established
(
40
CFR
180.129)
for
the
combined
residues
of
OPP
and
Na­
OPP
from
postharvest
application
on
apples,
cantaloupes,
carrots,
cherries,
citrus,
cucumbers,
grapefruits,
kiwifruits,
kumquats,
lemons,
limes,
nectarines
oranges,
bell
peppers,
peaches,
pears,
pineapples,
plums,
and
prunes,
sweet
potatoes,
tangerines,
and
tomatoes.
In
addition,
OPP
is
used
in
applications
to
hard
surfaces,
(
walls,
floors,
barns)
agricultural
premises
and
equipment,
air
deodorization,
commercial
and
institutional
premises,
medical
premises,
residential
and
public
access
premises
(
carpet,
hard
surfaces,
crack
and
crevice
treatment),
and
material
preservatives
(
stains,
and
paints,
metal
working
fluids,
textiles,
paper
slurries
and
cement
mixtures,
glues,
and
adhesives,
and
consumer,
household
and
institutional
cleaning
products).

Sodium
o­
phenylphenate
(
Na­
OPP)
is
the
only
chemical
in
the
RED
case
that
is
formulated
as
inert
ingredient.
Sodium
o­
phenylphenate
is
formulated
as
inert
ingredient
in
approximately
123
registered
end­
use
products.
The
types
of
products
that
contain
sodium
o­
phenylphenate
as
an
inert
ingredient
include:
turf
insecticides
and
herbicides;
garden
and
ornamental
insecticides
and
herbicides;
insect
repellant
for
pets;
and
indoor/
outdoor
crack
and
crevice
insecticides.
These
products
are
formulated
as
soluble
concentrates,
gels,
flowable
concentrates,
ready
to
use
liquids,
granular,
and
bait
traps.
The
vast
majority
of
these
products
contain
sodium
o­
phenylphenate
as
an
inert
ingredient
in
amounts
less
than
2%
of
the
formulation.
In
these
cases,
the
residues
on
food
have
an
exemption
from
the
requirement
of
a
tolerance
under
the
40
CFR
§
180.920
when
used
as
an
inert
ingredient
in
pesticide
formulations
that
are
applied
to
growing
crops.

Hazard
Characterization
The
toxicology
database
for
OPP
is
complete,
with
the
exception
of
acute
dermal
toxicity
(
870.1200),
acute
inhalation
toxicity
(
870.1300),
and
primary
eye
irritation
(
870.2400).
Acceptable
acute
toxicity
studies
for
these
guidelines
must
be
submitted.
A
complete
toxicology
profile
for
OPP
can
be
found
in
the
toxicology
disciplinary
chapter
for
OPP.

The
Health
Effects
Division's
Carcinogenicity
Assessment
Review
Committee
(
CARC)
classified
OPP
and
NA­
OPP
as
"
Not
Likely
to
be
Carcinogenic
to
Humans"
below
a
defined
dose
range,
based
on
convincing
evidence
that
carcinogenic
effects
are
not
likely
below
200
mg/
kg/
day
in
experimental
animal
studies.
This
classification
is
based
on
Page
5
of
60
convincing
evidence
of
a
non­
linear
mode
of
action
for
development
of
bladder
tumors
in
carcinogenicity
studies
in
rats.
High
doses
of
OPP
(>
200
mg/
kg/
day)
lead
to
saturation
of
phase
II
detoxification
enzyme
pathways,
resulting
in
increased
amounts
of
the
oxidative
metabolites
phenylhydroquinone
(
PHQ)
and/
or
phenylbenzoquinone
(
PBQ).
The
generation
of
PBQ
is
considered
dose­
dependent,
appearing
in
increased
quantity
only
at
higher
doses
of
OPP
(>
200
mg/
kg/
day).
The
shift
in
biotransformation
products
with
increased
dose
of
OPP
has
been
postulated
to
be
associated
with
the
non­
linear
response
observed
in
tumorigenicity
of
the
urinary
bladder,
involving
oxidative
damage
to
cells
and
subsequent
regenerative
hyperplasia.
With
continued
exposure,
this
process
leads
to
development
of
tumors.
Evidence
suggests
that
a
non­
genotoxic
mode
of
action
is
operative.

OPP
and
NA­
OPP
were
also
classified
by
the
CARC
as
"
Likely
to
be
Carcinogenic
to
Humans,"
based
on
the
presence
of
urinary
bladder
tumors
in
rats
and
the
presence
of
liver
tumors
in
mice
at
doses
above
200
mg/
kg/
day.
This
classification
is
based
on
the
fact
that
insufficient
data
were
provided
to
support
a
mode
of
action
for
the
mouse
liver
tumors.
Although
the
tumors
were
benign
and
observed
only
in
one
sex
at
high
doses,
more
data
are
required
for
any
conclusion
to
be
drawn
regarding
the
mode
of
action
for
these
tumors.

The
CARC
noted
that
although
OPP
and
NA­
OPP
are
classified
as
"
Likely
to
be
Carcinogenic
to
Humans"
above
a
defined
dose
range,
quantification
of
cancer
risk
is
not
required
since
the
NOAEL
selected
for
the
chronic
Reference
Dose
(
39
mg/
kg/
day,
selected
from
the
combined
chronic
toxicity/
carcinogenicity
study
in
rats
[
MRIDs
43954301,
44852701,
44832201]
based
on
decreased
body
weight
gains,
decreased
food
consumption
and
reduced
food
efficiency,
and
increased
clinical
and
gross
pathological
signs
of
toxicity
at
the
LOAEL
of
200
mg/
kg/
day)
is
sufficiently
protective
of
the
key
events
involved
in
the
carcinogenic
mode
of
action,
which
are
not
present
at
doses
below
200
mg/
kg/
day
in
the
rat
and
is
also
protective
of
liver
adenomas
occurring
at
500
mg/
kg/
day
in
the
mouse.
Thus,
the
precursor
events
leading
to
development
of
bladder
and
liver
tumors
are
not
likely
to
occur
using
the
NOAEL
selected
for
the
chronic
RfD
value
and
this
value
is
thus
protective
against
development
of
tumors.

Dose­
Response
Assessment
On
October
20,
2004,
the
Antimicrobials
Division
Toxicology
Endpoint
Selection
Committee
(
ADTC)
reviewed
the
available
toxicology
data
for
OPP
and
selected
endpoints
for
use
as
appropriate
in
occupational/
residential
exposure
risk
assessments.
The
potential
for
increased
susceptibility
of
infants
and
children
from
exposure
to
OPP
was
also
evaluated
by
the
committee
in
order
to
meet
the
statutory
requirements
of
the
Food
Quality
Protection
Act
(
FQPA)
of
1996.
The
committee
concluded
that:
an
acute
dietary
risk
assessment
is
not
required
for
OPP,
because
a
single
dose
effect
from
OPP
was
not
identified.
For
chronic
dietary
risk
assessment,
a
NOAEL
value
of
39
mg/
kg/
day
from
the
combined
chronic
toxicity/
carcinogenicity
study
in
rats
(
MRIDs
43954301,
44852701,
44832201)
was
identified,
based
on
decreased
body
weight,
body
weight
gain,
food
consumption
and
food
efficiency,
increased
clinical
and
gross
Page
6
of
60
pathological
signs
of
toxicity
at
a
dose
of
200
mg/
kg/
day.
For
dietary
risk
assessments,
an
uncertainty
factor
of
100
is
assigned
(
10x
inter­
species
extrapolation,
10x
intra­
species
variation).
As
the
FQPA
factor
was
reduced
to
1x,
the
resulting
chronic
reference
dose
is
0.39
mg/
kg/
day.

For
short­
term
incidental
oral
risk
assessments
(
1­
30
days),
a
NOAEL
value
of
100
mg/
kg/
day
was
selected
from
the
developmental
toxicity
study
in
rats
(
MRIDs
00067616
and
92154037),
based
on
clinical
observations
of
toxicity,
decreased
weight
gain,
food
consumption
and
food
efficiency
observed
at
the
next
higher
dose
of
300
mg/
kg/
day.
An
uncertainty
factor
of
100
was
assigned
to
this
endpoint
(
10x
inter­
species
extrapolation,
10x
intra­
species
variation).
For
intermediate­
term
incidental
oral
risk
assessments,
a
NOAEL
value
of
39
mg/
kg/
day
was
selected
from
the
combined
chronic
toxicity/
carcinogenicity
stud
in
rats.
(
MRIDs
43954301,
44852701,
44832201),
based
on
decreased
body
weight,
body
weight
gain,
food
consumption
and
food
efficiency,
increased
clinical
and
gross
pathological
signs
of
toxicity
at
a
dose
of
200
mg/
kg/
day.
For
risk
assessments,
an
uncertainty
factor
of
100
was
selected
(
10x
inter­
species
extrapolation,
10x
intra­
species
variation).

For
short­
term
dermal
risk
assessment
(
1­
30
days),
a
NOAEL
of
100
mg/
kg/
day
was
selected
from
the
21­
day
dermal
toxicity
study
in
rats
(
MRID
42881901),
based
on
dermal
irritation
(
erythema,
scaling)
at
the
site
of
test
substance
application
at
the
next
highest
dose
of
500
mg/
kg/
day.
This
is
a
route­
specific
study
and
is
also
appropriate
for
the
time
frame
of
the
risk
assessment.
For
risk
assessments,
an
uncertainty
factor
of
100
was
assigned
(
10x
inter­
species
extrapolation,
10x
intra­
species
variation).

For
intermediate­
term
and
long­
term
dermal
risk
assessments,
a
NOAEL
value
of
39
mg/
kg/
day
was
selected
from
the
combined
chronic
toxicity/
carcinogenicity
stud
in
rats.
(
MRIDs
43954301,
44852701,
44832201),
based
on
decreased
body
weight,
body
weight
gain,
food
consumption
and
food
efficiency,
increased
clinical
and
gross
pathological
signs
of
toxicity
at
a
dose
of
200
mg/
kg/
day.
For
risk
assessments,
an
uncertainty
factor
of
100
was
assigned
(
10x
inter­
species
extrapolation,
10x
intra­
species
variation).

There
are
no
repeated
dose
inhalation
toxicity
studies
available
for
OPP.
Thus,
oral
endpoints
were
used.
For
assessment
of
short­
term
inhalation
risk,
a
NOAEL
value
of
100
mg/
kg/
day
was
selected
from
the
developmental
toxicity
study
in
rats
(
MRIDs
00067616
and
92154037),
based
on
clinical
observations
of
toxicity,
decreased
weight
gain,
food
consumption
and
food
efficiency
observed
at
the
next
higher
dose
of
300
mg/
kg/
day.
An
uncertainty
factor
of
100
was
assigned
(
10x
inter­
species
extrapolation,
10x
intra­
species
variation).
An
additional
database
uncertainty
factor
of
10x
was
assigned
in
addition
to
determine
the
need
for
a
confirmatory
inhalation
toxicity
study.

For
intermediate­
and
long­
term
inhalation
risk
assessments,
a
NOAEL
value
of
39
mg/
kg/
day
was
selected
from
the
combined
oral
chronic
toxicity/
carcinogenicity
stud
in
rats.
(
MRIDs
43954301,
44852701,
44832201),
based
on
decreased
body
weight,
body
weight
gain,
food
consumption
and
food
efficiency,
increased
clinical
and
gross
pathological
signs
of
toxicity
at
a
dose
of
200
mg/
kg/
day.
An
uncertainty
factor
of
100
Page
7
of
60
was
assigned
(
10x
inter­
species
extrapolation,
10x
intra­
species
variation).
An
additional
database
uncertainty
factor
of
10x
was
assigned
in
addition
to
determine
the
need
for
a
confirmatory
inhalation
toxicity
study.
If
estimated
MOEs
fall
below
1000
for
intermediate
and
long­
term
inhalation
risk,
a
confirmatory
route­
specific
inhalation
toxicity
study
may
be
required.

FQPA
Considerations
The
ADTC
recommended
that
the
special
hazard­
based
FQPA
safety
factor
be
reduced
to
1x
for
OPP.
There
are
available
developmental
toxicity
and
reproductive
toxicity
studies
for
OPP
that
are
considered
acceptable
and
that
show
no
evidence
of
increased
toxicity
to
offspring
at
the
same
or
lower
doses
as
those
causing
parental/
systemic
toxicity
or
evidence
of
more
severe
toxicity
relative
to
parental/
systemic
toxicity.

Dietary
Exposure
and
Risk
Exposure
from
the
direct
and
indirect
food
uses
for
OPP
as
well
as
the
inert
uses
of
OPP
that
result
in
dietary
exposure
have
been
assessed.
Exposure
estimates
from
direct
food
uses
were
developed
using
the
Dietary
Exposure
Evaluation
Model
software
with
the
Food
Commodity
Intake
Database
(
DEEM­
FCID),
Version
2.00,
which
incorporates
consumption
data
from
USDA's
Continuing
Surveys
of
Food
Intakes
by
Individuals
(
CSFII),
1994­
1996
and
1998.
Exposure
estimates
from
indirect
food
uses
of
OPP
in
counter
top
disinfectants,
dishwashing
disinfectants,
paper
slimicides,
paper
coatings,
and
paper
adhesives
were
developed
using
FDA
methodology.
Exposure
estimates
from
inert
uses
of
Na­
OPP
were
developed
using
DEEM­
FCID.

Results
of
direct
food
exposure
showed
that
for
the
adult
U.
S.
population,
7.1%
of
the
chronic
Population
Adjusted
Dose
(
cPAD)
was
occupied
from
this
exposure,
while
for
children,
19.9%
of
the
cPAD
was
occupied
for
children
ages
1­
6,
the
highest
exposed
subpopulation.
From
indirect
food
exposure,
aggregate
dietary
exposure
occupied
20%
and
29%
of
the
cPAD
for
adults
and
children
respectively.
From
the
inert
uses
of
Na­
OPP,
1.5%
of
the
cPAD
was
occupied
from
adult
exposure,
while
5.4%
was
occupied
from
the
highest
exposed
subpopulation
of
children
(
ages
1­
2).
These
percentages
are
all
below
100%
of
the
cPAD
and
are
thus
do
not
pose
a
risk
of
concern.

Drinking
Water
Exposure
and
Risk
Residues
of
OPP
are
not
expected
to
significantly
impact
surface
or
ground
water,
as
OPP
and
its
salts
are
known
to
breakdown
in
soils,
under
aerobic
as
well
as
anaerobic
conditions
within
a
few
hours
to
weeks
and
therefore
a
drinking
water
assessment
is
not
needed.

Residential
Handler
Exposure
and
Risk
Page
8
of
60
Several
residential
handler
exposure
scenarios
were
assessed
for
OPP,
including
use
on
indoor
and
outdoor
hard
surfaces,
air
deodorization,
fogging,
treated
plastics,
and
treated
paint.
Exposures
were
assessed
using
either
CMA
(
Chemical
Manufacturers
Association,
now
the
American
Chemistry
Council)
data,
PHED
data
presented
in
HED's
Residential
SOPs,
or
(
for
inhalation)
EPA's
Wall
Paint
Exposure
Model.
The
duration
of
exposure
assessed
was
primarily
short­
term
exposures,
because
the
residential
uses
are
expected
to
be
episodic
in
nature
and
not
daily.
The
resulting
short­
term
exposures
and
MOEs
for
the
representative
residential
handler
scenarios
were
above
the
target
dermal
and
inhalation
MOE
of
100
for
all
scenarios.
Furthermore,
all
short­
term
inhalation
MOEs
for
exposure
to
aerosolized
paint
are
above
the
target
MOE
of
100.
Results
of
exposure
to
chemical
vapor
exposure
from
treated
paint
using
the
Wall
Paint
Exposure
Model
showed
that
the
inhalation
(
vapor)
MOE
for
the
short­
term
exposure
for
the
homeowner
painter
is
above
the
target
MOE
of
100.

For
residential
post­
application
assessment,
scenarios
were
developed
that
encompass
multiple
products,
but
still
represent
a
high
end
exposure
scenario
for
all
products
represented
for
purposes
of
a
screening­
level
assessment.
Representative
postapplication
scenarios
assessed
include
contacting
treated
hard
surfaces/
floors
(
dermal
and
incidental
oral
exposure
to
children),
wearing
treated
clothing
(
dermal
exposure
to
adults
and
children),
wearing
treated
diapers
(
dermal
exposure
to
infants),
mouthing
treated
textiles
such
as
clothing
and
blankets
(
incidental
oral
exposure
to
children),
and
mouthing
treated
plastic
toys
(
incidental
oral
exposure
to
infants).
Additionally,
postapplication/
bystander
inhalation
exposures
were
assessed
for
use
of
the
disinfecting/
deodorizing
products
(
vapor
exposure
to
adults
and
children)
and
paints
(
vapor
exposure
to
adults
and
children).
As
with
residential
handler
scenarios,
most
exposures
were
assessed
for
shortterm
duration
only.
However,
it
is
believed
that
intermediate­
term
exposure
to
children
may
occur
in
day
care
centers
where
disinfecting
products
are
used
more
frequently.
Additionally,
it
is
believed
that
exposures
will
occur
on
a
continuous
basis
for
infants
wearing
treated
diapers.
Therefore,
short­,
intermediate­
and
long­
term
(>
6
months)
exposures
were
necessary
to
assess
this
scenario.

Results
of
the
post­
application
residential
assessment
showed
that
for
short­
and
intermediate­
term
dermal
exposures
of
children
contacting
treated
floors,
dermal
MOEs
for
short­
term
(
150)
and
intermediate­
term
(
930)
were
above
the
target
level
of
100
and
thus
not
of
concern.
Short­
and
intermediate­
term
incidental
oral
exposures
of
children
contacting
treated
floors
were
also
above
the
target
MOE
of
100
(
1,200
and
6,900
respectively)
and
thus
are
not
of
concern.

For
short­
term
dermal
exposure
of
adults
and
children
wearing
treated
clothing,
the
dermal
MOEs
for
children
were
below
the
target
MOE
of
100
using
the
100%
transfer
factor
(
MOE
<
1)
and
using
the
5%
transfer
factor
(
MOE
=
16).
For
adults,
the
dermal
MOEs
were
also
below
the
target
MOE
of
100
using
both
the
100%
transfer
factor
(
MOE
=
1)
and
the
5%
transfer
factor
(
MOE
=
25)
and
thus
present
risks
of
concern
for
this
scenario.
In
addition
to
treated
clothing,
there
is
the
potential
for
dermal
exposure
to
infants
wearing
cloth
diapers
treated
with
a
trigger­
pump
spray
product
containing
OPP.
Page
9
of
60
Though
it
is
likely
that
the
diapers
treated
with
this
product
would
be
washed
prior
to
use,
the
label
does
not
provide
specific
use
instructions
pertaining
to
washing.
Therefore,
a
post­
application
assessment
assuming
no
laundering
was
conducted
as
a
conservative
measure.
Calculation
of
short­,
intermediate­,
and
long­
term
dermal
doses
and
MOE
for
infants
wearing
treated
cloth
diapers
showed
all
MOEs
below
the
target
of
100
using
a
transfer
factor
of
either
100%
or
5%.

For
incidental
oral
exposures
of
children
mouthing
treated
textiles
or
treated
toys,
calculation
of
incidental
oral
MOEs
showed
no
risks
of
concern
from
these
exposures
(
MOEs
of
300
and
2,400
respectively).

Inhalation
exposures
of
adults
and
children
from
exposure
to
air
deodorizers
containing
OPP
were
assessed
using
the
Multi­
Chamber
Concentration
and
Exposure
Model
(
MCCEM
v1.2)
to
present
a
screening­
level
estimate
of
the
potential
inhalation
risk.
For
both
adults
and
children,
the
calculated
inhalation
MOEs
are
greater
than
the
target
MOE
of
100.
Furthermore,
these
MOEs
are
also
greater
than
1,000
therefore;
an
additional
inhalation
toxicity
study
is
not
warranted
based
on
the
results
of
this
scenario.
The
MCCEM
model
was
also
used
to
assess
post­
application
inhalation
exposures
for
entry
into
a
room
after
a
fogging
application.
All
of
the
adult
and
child
inhalation
MOEs
were
above
the
target
MOE
of
100.
All
of
the
MOEs
for
children
were
below
1,000.
However,
the
ST
vapor
inhalation
exposures
to
adults
for
a
0­
hr
REI
and
a
4­
and
24­
hour
exposure
duration
along
with
the
ST
vapor
inhalation
exposure
to
adults
for
a
4­
hr
REI
and
24
hour
exposure
duration
were
below
1,000.
Therefore,
the
based
on
the
results
of
these
scenarios
for
which
the
calculated
MOEs
are
below
1,000,
the
Agency
may
request
that
a
confirmatory
inhalation
toxicity
study
be
conducted.

Post­
application
inhalation
exposure
to
OPP
from
use
in
paint
was
estimated
using
the
Wall
Paint
Exposure
Model
(
WPEM)
version
3.2.
Both
the
child
and
adult
inhalation
MOEs
are
above
the
target
MOE
of
100,
but
below
a
value
of
1,000.
Since
the
MOEs
are
below
1,000,
the
Agency
may
request
that
a
confirmatory
inhalation
toxicity
study
be
conducted.

Aggregate
Exposure
and
Risk
Acute
and
Chronic
Dietary
Aggregate
Risk:
Aggregate
dietary
risk
includes
exposure
from
direct
food
uses,
indirect
food
uses,
inert
uses,
and
exposure
from
drinking
water.
As
an
acute
dietary
endpoint
of
concern
was
not
identified
for
OPP,
and
as
there
are
no
concerns
for
surface
or
ground
water
residues
of
OPP,
the
aggregate
dietary
risk
can
be
addressed
from
the
direct
and
indirect
food
uses
of
OPP.
Dietary
exposure
from
conventional
uses
of
OPP
is
detailed
in
a
separate
memorandum
from
the
Health
Effects
Division
of
the
Office
of
Pesticide
Programs
(
D319639),
while
dietary
exposure
from
the
indirect
food
uses
of
OPP
have
been
detailed
in
a
separate
memorandum
(
A
Memo
from
Bob
Quick,
to
Najm
Shamim,
2006).
Dietary
exposure
from
the
inert
uses
of
NA­
OPP
is
detailed
in
a
separate
memorandum
as
well
(
Talia
Milano
and
Cassi
Walls,
Ph.
D.,
February
2006).
Aggregate
dietary
risk
from
these
sources
occupy
31.5%
of
the
cPAD
Page
10
of
60
for
adults
and
68.7%
of
the
cPAD
for
children.
These
aggregate
risk
estimates
are
all
below
100%
of
the
cPAD
for
OPP
and
thus
there
is
no
risk
of
concern.

Short­
and
Intermediate­
term
aggregate
risk:
Short­
and
intermediate­
term
aggregate
exposures
and
risks
include
food
and/
or
water
exposures
in
conjunction
with
relevant
residential
exposures
from
both
the
active
and
inert
uses
of
OPP
and
NA­
OPP.
In
the
case
of
OPP,
short­
and
intermediate­
term
aggregate
risks
were
assessed
for
adults
and
children
that
could
be
exposed
to
OPP
and
OPP
salt
residues
from
the
use
of
products
in
non­
occupational
environments.
Since
the
short­
term
dermal
toxicity
endpoint
(
NOAEL
of
100
mg/
kg/
day
from
a
21­
day
dermal
toxicity
study)
was
based
on
skin
irritation,
in
comparison
to
a
different
effect
from
the
short­
term
oral
and
inhalation
end
points
(
NOAEL
of
100
mg/
kg/
day
from
developmental
toxicity
studies),
short­
term
dermal
exposures
were
not
aggregated
with
the
short­
term
inhalation
and
oral
exposures.
Intermediate­
term
toxicity
endpoints
for
all
of
the
routes
of
exposure
(
oral,
dermal
and
inhalation)
are
based
on
the
same
study
and
same
toxic
effect
(
NOAEL
of
39
mg/
kg/
day
from
a
chronic/
carcinogenicity
study);
therefore,
all
intermediate­
term
routes
were
aggregated
together.
The
Total
MOE
method
was
employed
to
assess
aggregate
risk.
This
method
is
found
at
http://
www.
epa.
gov/
pesticides/
trac/
science/
aggregate.
pdf.
When
dietary
exposures
were
aggregated
with
oral
and
inhalation
residential
exposure
scenarios,
the
aggregate
short­
term
Margin
of
Exposure
(
MOE)
for
adults
was
333,
and
the
aggregate
short­
term
MOE
for
children
was
355.
Intermediate­
term
aggregate
risk
(
children
only)
was
calculated
to
be
247.
Aggregate
dermal
risk
(
MOE)
for
adults
was
calculated
to
be
141,
and
the
aggregate
MOE
for
children
was
111.
These
values
are
above
the
target
MOE
of
100
and
are
thus
not
of
concern.

Occupational
Exposure
Occupational
handler
exposures
were
assessed
for
numerous
scenarios
under
the
Use
Site
Categories
(
USC)
of
agricultural
premises,
food
handling
premises,
commercial/
institutional/
industrial
premises,
and
medical
premises.
Additionally,
occupational
exposure
can
occur
during
the
preservation
of
materials
that
are
used
for
household,
institutional,
and
industrial
uses,
along
with
the
preservation
of
wood.
A
detailed
analysis
is
presented
in
the
occupational
and
residential
exposure
chapter
for
OPP
(
D320537).
In
summary,
the
results
of
occupational
handler
analysis
indicated
no
risks
of
concern
with
the
exception
of
the
following
MOEs
are
slightly
below
the
target
MOE
of
100:

 
Agricultural
premises,
fogging:
intermediate­
term
PPE
Total
MOE
=
98.
The
IT
inhalation
MOE
=
880,
and
is
below
1,000
so
that
the
Agency
may
request
a
confirmatory
inhalation
toxicity
study.
 
Commercial/
Institutional
premises,
wiping:
short­
term
baseline
dermal
MOE=
74,
intermediate­
term
baseline
dermal
MOE
=
68,
and
intermediate­
term
baseline
Total
MOE
=
64.
 
Medical
premises,
mopping:
short­
term
baseline
dermal
MOE=
93,
intermediate­
term
baseline
dermal
MOE
=
84,
and
intermediate­
term
baseline
Total
MOE
=
78.
Page
11
of
60
 
Materials
Preservatives,
liquid
pour
preservation
of
textiles:
short­
term
PPE
dermal
MOE=
92,
intermediate­
term
PPE
dermal
MOE
=
83,
and
intermediate­
term
Total
MOE
=
78.
 
Materials
Preservatives,
painter
(
applying
paint
post­
preservation),
airless
sprayer:
baseline
dermal
short­
term
MOE
=
66.
 
Professional
Painters:
short
term
inhalation
exposure
MOE
=
43,
which
is
below
the
target
MOE
of
100.

An
occupational
post­
application
assessment
was
only
conducted
for
inhalation
exposures
as
a
result
of
entry
into
a
building
after
a
fogging
application,
because
dermal
post
application
is
presumed
to
be
negligible.
The
inhalation
exposure
assessment
was
conducted
using
the
Multi­
Chamber
Concentration
and
Exposure
Model
(
MCCEM
v1.2).
Both
the
short­
term
MOE
(
690)
and
the
intermediate­
term
MOE
(
270)
were
above
the
target
MOE
of
100
but
below
1,000.
Therefore,
the
Agency
may
request
that
a
confirmatory
inhalation
toxicity
study
be
submitted
since
the
current
inhalation
endpoint
is
based
on
an
oral
toxicity
study.

In
addition,
there
are
also
occupational
exposure
risks
as
a
result
of
using
materials
that
have
been
already
treated
with
OPP
and
OPP
Salt
products.
These
include
metalworking
fluids
and
wood.

There
is
a
potential
for
dermal
and
inhalation
exposure
when
a
worker
handles
treated
metalworking
fluids.
This
route
of
exposure
occurs
after
the
chemical
has
been
incorporated
into
the
metalworking
fluid
and
a
machinist
is
using/
handling
this
treated
end­
product.
The
short­
term
dermal
MOE
=
54
shows
a
risk
of
concern
for
exposure
to
metalworking
fluid
treated
with
OPP,
and
there
is
no
concern
with
the
inhalation
risks
associated
with
exposure
to
already
treated
fluids.

OPP
and
OPP
salts
are
used
in
products
that
are
intended
to
preserve
wood
(
non­
pressure
treatment).
There
is
the
worker
function
of
incorporating
the
wood
preservative
into
the
slurry.
For
this
liquid
pump
treatment
when
workers
add
the
preservative
to
the
wood
slurry,
the
MOEs
are
above
the
target
MOE
of
100
and
therefore
do
not
pose
a
concern.
However,
the
IT
inhalation
MOE
(
840)
for
the
blender/
spray
operators
adding
the
chemical
via
closed­
liquid
pumping
is
less
than
1,000
and
therefore
a
confirmatory
inhalation
toxicity
study
is
warranted
based
on
these
results.

There
are
also
several
other
job
functions
that
pose
a
risk
for
handlers
to
come
into
contact
with
OPP
or
OPP
Salt
preserved
wood.
For
all
worker
functions,
which
include,
chemical
operators,
graders,
millwrights,
clean­
up
crews,
trim
saw
operators
and
dip
tank
operators,
the
dermal,
inhalation
and
total
MOEs
are
not
of
concern.

Environmental
Fate
Assessment
Orthophenylphenol
is
stable
and
persistent
in
abiotic
aqueous
medium
at
pHs
5,
7
and
9.
It
degrades
completely
in
14
days
when
exposed
to
sunlight
and
is
therefore,
photolytically
unstable
in
neutral
aqueous
medium.
When
exposed
to
UV
light
(
253.7
Page
12
of
60
nm),
it
degrades
into
phenylbenzoquinone,
pehnylhydroquinone,
and
2­
hydroxy
benzofuran.
Its
half­
life
is
(
measured
against
hydroxyl
radical)
14
hours
and
is
unstable
in
the
atmosphere.
It
has
a
high
KOC
value
of
10,000
and
is
immobile
in
soils
and
is
likely
to
remain
on
the
soil
surfaces.
It
is
not
likely
to
migrate
into
ground
water.
Its
major
degradation
pathway
appears
to
be
through
biodegradation
under
aerobic
and
anaerobic
conditions.
The
observed
half
lives
vary
from
a
few
hours
to
three
weeks.
Hence
even
though
it
is
likely
to
stay
on
soil
surfaces,
it
biodegrades
under
aerobic
and
aerobic
soil
conditions.
Thus
it
is
not
likely
to
contaminate
surface
water
(
drinking
water).
The
sodium
salt
of
OPP
(
applied
as
an
antisapstain
wood
treatment)
has
been
shown
to
leach
out
up
to
58%
within
first
day
after
treatment
highest
leach
rate:
71
µ
g/
cm2
/
day
on
day
one)
and
up
to
82
%
within
14
days
after
treatment
(
maximum
application
rate
is
4%
of
NA­
OPP).
The
exposure
from
the
leaching
of
OPP/
NA­
OPP
from
wood
treated
for
antisapstain
purposes
cannot
be
addressed
at
this
time
due
to
a
lack
of
leaching
information.
The
registrants
have
completed
an
antisapstain
leaching
study
from
the
treated
wood.
The
wooden
blocks
were
treated
with
1%
and
4%
DOWICIDE
A.
Since
the
DOWICIDE
A
contains
71.1%
actives,
actual
dosings
of
SOPP
were
0.71
and
2.84%,
respectively).
The
study
showed
that
under
experimental
conditions,
1%
and
4
%
solutions
of
SOPP
leached
52
to
58%
from
the
treated
wooden
blocks
within
the
first
day;
after
14
days,
78­
82
%
of
SOPP
leached
out
from
the
treated
wooden
blocks.

Leach
rates
were:
1%
solution
71
µ
g
SOPP/
cm2
/
day
and
for
4%
solution:
192
µ
g/
SOPP/
cm2
/
day
for
the
first
day;
after
14
days,
leach
rates
were:
0.5
to
2.0
µ
g/
cm2
/
day
for
both
solutions.
Maximum
leaching
occurred
within
the
first
day
and
attained
pseudo
equilibrium
after
14
days.
At
the
end
of
the
experiment
20­
24%
SOPP
was
extracted
from
the
wooden
blocks.
(
Orthophenylphenol:
Determination
of
the
leaching
rate
from
Wood
following
a
simulated
Sapstain
Treatment,
The
Dow
Chemical
Company,
Study
ID#:
051089,
2005,
DP
Barcode:
319656)

Ecological/
Environmental
Risk
Assessment
2­
phenylphenol
and
its
salts
demonstrate
low
toxicity
to
birds,
and
moderate
toxicity
to
mammals,
freshwater
fish,
freshwater
invertebrates,
and
algae.

The
low
exposure
potential
from
the
indoor
uses
of
2­
phenylphenol
and
salts,
coupled
with
the
tendency
for
the
compounds
to
degrade
under
environmental
conditions,
result
in
low
likelihood
of
adverse
acute
effects
to
wildlife
and
aquatic
organisms
from
the
indoor
uses.
Based
on
the
results
of
the
antisapstain
modeling,
runoff
from
antisapstain
treating
facilities
will
exceed
acute
high
risk,
restricted
use,
and
endangered
species
LOCs
for
freshwater
fish,
freshwater
invertebrates,
and
aquatic
plants.
Chronic
risks
cannot
be
assessed
at
this
time
due
to
a
lack
of
chronic
toxicity
data.

The
model
used
to
estimate
exposure
from
antisapstain
uses
is
intended
as
a
Tier
I
screening
model,
and,
as
such,
has
inherent
assumptions
and
uncertainties
that
may
result
in
over­
or
under­
estimation
of
exposure
levels.
Since
the
model
is
only
intended
as
a
screening­
level
model,
further
refinement
of
the
model
is
recommended
to
more
accurately
assess
risks
from
the
antisapstain
uses
of
2­
phenylphenol.
Page
13
of
60
Methods
to
reduce
the
amount
of
2­
phenylphenol
potentially
released
from
antisapstaintreated
wood
could
potentially
mitigate
the
risks.
Possible
mitigation
methods
might
include,
but
are
not
limited
to,
lowering
the
application
rate
or
requiring
specific
storage
conditions
to
prevent
exposure
of
recently
treated
wood
to
weather
(
e.
g.,
full
covering)
and/
or
prevent
the
release
of
any
associated
runoff
into
aquatic
habitats
(
e.
g.,
drip
pads).
2­
phenylphenol
is
not
very
mobile
in
soils,
so
any
2­
phenylphenol
leached
outdoors
will
likely
bind
to
soils
and
not
reach
aquatic
habitats
as
free
2­
phenylphenol.
An
environmental
monitoring
study
of
runoff
from
antisapstain
facilities
is
needed
to
address
the
potential
risks
of
concern
and
provide
estimated
environmental
concentrations
(
EEC)
to
use
in
a
refined
risk
assessment.
In
the
interim,
precautions
to
limit
leaching
and
runoff
from
antisapstain
treatment
facilities
areas
(
see
Label
Hazard
Statements
and
Use
Recommendations
section,
below)
should
prevent
exposure
to
aquatic
organisms.

Endocrine
Disruption
Laboratory
studies
indicate
that
2­
phenylphenol
(
aka
2­
hydroxybiphenol)
demonstrates
some
potential
to
act
as
an
endocrine
disruptor.
When
the
appropriate
screening
and/
or
testing
protocols
being
considered
under
the
Agency's
Endocrine
Disruptor
Screening
and
Testing
Advisory
Committee
(
EDSTAC)'
s
Endocrine
Disruptor
Screening
Program
(
EDSP)
have
been
developed,
2­
phenylphenol
may
be
subjected
to
additional
screening
and/
or
testing
to
better
characterize
effects
related
to
endocrine
disruption.

Endangered
Species
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
A
no
effect
@

determination.
The
active
ingredient
uses
of
2­
phenylphenol,
with
the
exception
of
the
antisapstain
wood
preservation
use,
fall
into
this
category.
Using
Tier
I
screening
modeling
to
assess
potential
exposure
from
antisapstain
wood
preservation
uses
of
2­
phenylphenol,
risks
to
Listed
Species
are
indicated.
Since
the
model
is
only
intended
as
a
screening­
level
model,
and,
as
such,
has
inherent
uncertainties
and
limitations
which
may
result
in
inaccurate
exposure
estimations,
further
refinement
of
the
model
is
recommended
before
any
regulatory
action
is
taken
regarding
the
antisapstain
uses
of
2­
phenylphenol
.
Additionally,
impacts
from
the
antisapstain
use
could
potentially
be
mitigated
with
precautions
to
prevent
leaching
and
runoff
when
wood
is
stored
outdoors
(
see
Label
Hazard
Statements/
Use
Recommendations,
below).
Due
to
these
circumstances,
the
Agency
defers
making
a
determination
for
the
antisapstain
uses
of
2­
phenylphenol
until
additional
data
and
modeling
refinements
are
available.
At
that
time,
the
environmental
exposure
assessment
of
the
antisapstain
use
of
2­
phenylphenol
will
be
revised,
and
the
risks
to
Listed
Species
will
be
reconsidered.
Page
14
of
60
Data
Gaps:

The
following
ecological
effects
data
gaps
exist
for
the
registered
uses
of
2­
phenylphenol
and
salts:

Marine/
estuarine
organism
acute
testing
(
72­
3/
850.1075,
850.1035/
1045,
and
850.1025/
1055)
(
These
studies
have
recently
been
submitted
to
the
Agency
and
are
currently
undergoing
review).

Aquatic
organism
chronic
toxicity
testing
(
72­
4a/
850.1300
and
72­
4b/
850.1400)

Terrestrial
plant
toxicity
testing
using
rice
(
123­
1/
850.4225
and
850.4250)
(
These
studies
have
recently
been
submitted
to
the
Agency
and
are
currently
undergoing
review).

Aquatic
plant
toxicity
testing
on
four
species
(
123­
2/
850.4400
and
850.5400)
(
These
studies
have
recently
been
submitted
to
the
Agency
and
are
currently
undergoing
review).

Monitoring
study
of
runoff
from
antisapstain
facilities
to
establish
EEC's
for
risk
assessment
Label
Hazard
Statements/
Use
Recommendations
2­
phenylphenol
and
salts
labels
must
state:

"
Do
not
discharge
effluent
containing
this
product
into
lakes,
streams,
ponds,
estuaries,
oceans,
or
other
waters
unless
in
accordance
with
the
requirements
of
a
National
Pollutant
Discharge
Elimination
System
(
NPDES)
permit
and
the
permitting
authority
has
been
notified
in
writing
prior
to
discharge.
Do
not
discharge
effluent
containing
this
product
to
sewer
systems
without
previously
notifying
the
local
sewage
treatment
plant
authority.
For
guidance
contact
your
State
Water
Board
or
Regional
Office
of
the
EPA."

Antisapstain
labels
must
state:
"
Treated
lumber
must
not
be
stored
outdoors
without
precautions
to
prevent
to
prevent
leaching
by
rainfall
to
the
environment.
Suitable
precautions
include:
covering
wood
with
plastic
or
other
impervious
covering,
installation
of
berms
and
placement
of
plastic
under
the
wood
to
prevent
surface
water
runoff
away
from
the
storage
area."

Incident
Reports
For
assessment
of
human
incidents,
several
databases
were
searched
for
available
information,
including
the
Office
of
Pesticides
Programs
(
OPP)
Incident
Data
System
(
IDS),
Poison
Control
Centers,
the
California
Department
of
Pesticide
Regulation,
the
National
Pesticide
Telecommunications
Network
(
NPTN),
and
the
published
scientific
peer­
reviewed
literature.
From
examination
of
these
databases,
OPP
and
salts
appear
to
cause
dermal
effects
which
are
perhaps
due
to
irritation.
Inhalation
is
another
route
which
Page
15
of
60
shows
some
symptoms.
However,
it
is
clear
that
all
the
databases
and
published
literature
show
that
specific
chemical
toxic
effects
can
not
be
attributed
specifically
to
OPP
or
NA­
OPP
or
K­
OPP
only,
as
most
of
the
symptoms
appear
in
a
mixture
of
active
ingredients,
one
of
them
OPP
or
its
salts.

2.0
PHYSICAL/
CHEMICAL
PROPERTIES
AND
CHARACTERIZATION
Chemical
Identity:

Chemical
Name:
Orthophenylphenol
(
or
2­
phenylphenol)
Chemical
Family:
Phenol
Common/
Trade
Name:
Dowcide1,
Preventol
O
extra
CAS
Number:
90­
43­
7
Molecular
Formula:
C12H20O
Chemical
Structure:

OH
Orthophenylphenol
Table
2­
1
Chemical
Characteristics
for
Technical
Grade
Active
OPP
Molecular
Weight
170.2
Color
Colorless
Physical
State
Solid
(
flakes)
Specific
Gravity
1.2
Dissociation
Constant
9.9
at
25
o
C
pH
6.1
in
aqueous
solution
at
22.7
o
C
Stability
Stable
at
normal
conditions
Melting
Point
56­
58
o
C
Boiling
Point
286
o
C
Water
Solubility
700
mg/
L
at
25
o
C
Octanol­
Water
Partition
constant
(
LogKOW)
3.3
Vapor
Pressure
2
x
10­
3
mm
Hg
at
25
o
C
Chemical
Identity
Chemical
Name:
Sodium
orthophenylphenol
(
NA­
OPP)
Chemical
Family:
Phenol
Common/
Trade
Names:
Dowcide
A,
Preventol
ON
Extra
CAS
Number:
132­
27­
4
Molecular
Formula:
C12H19NaO
Page
16
of
60
Molecular
Structure:

Na­
OPP
(
Sodium
orthophenylphenate)

Table
2­
2
Chemical
Characteristics
for
Technical
Grade
NA­
OPP
Molecular
Weight
192.19
Color
White
to
light
buff
Physical
State
Solid
(
flakes)
Specific
Gravity
1.36
Dissociation
Constant
10
at
20
o
C
pH
12.
13.5
Stability
Stable
under
controlled
conditions
Melting
Point
298.5
o
C
Boiling
Point
N/
A
Octanol­
Water
Partition
Coefficient
(
Log
KOW)
0.59
Water
Solubility
60.6
g/
100
mL,
53.37
%
(
w/
w)
Vapor
Pressure
1.8
x
10­
9
mm
Hg
at
25
o
C
Chemical
Identity
Chemical
Name:
Potassium
Orthophenylphenate
(
K­
OPP)
Chemical
Family:
Phenol
Common/
Trade
Name:
Potassium
salt
CAS
Number:
13707­
65­
8
Molecular
Formula:
C12H19KO
Chemical
Structure:

K­
OPP
(
Potassium
Orthophenylphenate)
Page
17
of
60
Table
2­
3
Chemical
Characteristics
for
Technical
Grade
Active
Potassium­
o­
Phenylphenate
(
K­
OPP)
Molecular
Weight
208.30
Color
White
Physical
State
Solid
Specific
Gravity
n/
a
Dissociation
Constant
n/
a
PH
n/
a
Stability
n/
a
Melting
Point
230.7
C
Boiling
Point
n/
a
Octanol­
Water
Partition
Coefficient
(
Log
KOW)
0.59
Water
Solubility
Highly
water
soluble
Vapor
Pressure
1.91
x
10­
11
mm
Hg
at
25
C
3.0
HAZARD
CHARACTERIZATION
3.1
Hazard
Profile
Acute
Toxicity
The
acute
toxicity
database
for
2­
phenylphenol
and
salts
is
incomplete.
Acute
dermal
toxicity
(
870.1200),
acute
inhalation
toxicity
(
870.1300),
and
primary
eye
irritation
(
870.2400)
studies
must
be
submitted.
2­
phenylphenol
has
a
moderate
order
of
acute
toxicity
via
the
oral
route
of
exposure
(
Toxicity
Category
III).
For
dermal
irritation,
2­
phenylphenol
and
its
sodium
salt
are
severe
(
Toxicity
Category
I)
and
moderate
to
severe
(
Toxicity
Category
II)
irritants,
respectively.
2­
phenylphenol
and
its
sodium
salt
are
not
dermal
sensitizers.
The
acute
toxicity
profile
is
presented
in
Table
3­
1.

Table
3­
1
Acute
Toxicity
Profile
for
2­
Phenylphenol
and
Salts
Guideline
Number
Study
Type/
Test
substance
(%
a.
i.)
MRID
Number/
Citation
Results
Toxicity
Category
870.1100
(
§
81­
1)
Acute
Oral­
Rat
2­
phenylphenol
purity
99.9%
43334201
LD50
=
2733
mg/
kg
III
870.1100
(
§
81­
1)
Acute
Oral­
Rat
2­
phenylphenol,
sodium
salt
purity
99.1%
43334204
LD50
=
846
mg/
kg
(
male)
LD50
=
591
mg/
kg
(
female)
III
870.1200
(
§
81­
2)
Acute
Dermal­
Rat
OPP
99.73%
a.
i.
00078779
LD50
>
5000
mg/
kg
IV
870.1300
(
§
81­
3)
Acute
Inhalation­
Rat
OPP
99.75%
a.
i.
42333101
Unacceptable
Study
NA
Page
18
of
60
Table
3­
1
Acute
Toxicity
Profile
for
2­
Phenylphenol
and
Salts
Guideline
Number
Study
Type/
Test
substance
(%
a.
i.)
MRID
Number/
Citation
Results
Toxicity
Category
870.2400
(
§
81­
4)
Primary
Eye
Irritation­
Rabbit
Dowicide
®
1
00139884
Unacceptable
Study
NA
870.2500
(
§
81­
5)
Primary
Dermal
Irritation­
Rabbit
2­
phenylphenol
purity
99.9%
43334202
Primary
Irritant
I
870.2600
(
§
81­
6)
Dermal
Sensitization
­
Guinea
pig
2­
phenylphenol
purity
99.9%
43334203
Not
a
sensitizer.
No
870.2600
(
§
81­
6)
Dermal
Sensitization
­
Guinea
pig
2­
phenylphenol,
sodium
salt
purity
99.1%
43334205
Not
a
sensitizer.
No
In
accordance
with
the
EPA
Final
Guidelines
for
Carcinogen
Risk
Assessment
(
March
29,
2005),
the
Health
Effects
Division's
Carcinogenicity
Assessment
Review
Committee
(
CARC)
used
multiple
descriptors
for
the
classification
of
orthophenylphenol
and
sodium
orthophenylphenol
in
its
meeting
of
June
8,
2005.

OPP
and
NA­
OPP
were
classified
as
"
Not
Likely
to
be
Carcinogenic
to
Humans"
based
on
convincing
evidence
that
carcinogenic
effects
are
not
likely
below
a
defined
dose
range
(
i.
e,
below
200
mg/
kg/
day).
This
classification
is
based
on
the
following:
convincing
evidence
that
a
non­
linear
mode
of
action
for
bladder
tumors
was
established
in
rats.
High
doses
of
OPP
lead
to
saturation
of
phase
II
detoxification
enzyme
pathways,
resulting
in
increased
amounts
of
the
oxidative
metabolites
PHQ
and/
or
PBQ.
The
generation
of
PBQ
is
considered
dose­
dependent,
appearing
in
increased
quantity
only
at
higher
doses
of
OPP
(>
200
mg/
kg/
day).
The
shift
in
biotransformation
products
with
increased
dose
of
OPP
has
been
postulated
to
be
associated
with
the
non­
linear
response
observed
in
tumorigenicity
of
the
urinary
bladder,
involving
oxidative
damage
to
cells
and
subsequent
regenerative
hyperplasia.
With
continued
exposure,
this
process
leads
to
development
of
tumors.
Evidence
suggests
that
a
non­
genotoxic
mode
of
action
is
operative.

OPP
and
NA­
OPP
were
also
classified
as
"
Likely
to
be
Carcinogenic
to
Humans,"
based
on
the
presence
of
urinary
bladder
tumors
in
rats
and
the
presence
of
liver
tumors
in
mice
at
doses
above
200
mg/
kg/
day.
This
classification
is
based
on
the
fact
that
insufficient
data
were
provided
to
support
a
mode
of
action
for
the
mouse
liver
tumors.
Although
the
tumors
were
benign
and
observed
only
in
one
sex
at
high
doses,
more
data
are
required
for
any
conclusion
to
be
drawn
regarding
the
mode
of
action
for
these
tumors.
Page
19
of
60
The
CARC
noted
that
although
both
chemicals
are
classified
as
"
Likely
to
be
Carcinogenic
to
Humans"
above
a
defined
dose
range,
quantification
of
cancer
risk
is
not
required
since
the
NOAEL
selected
for
the
chronic
Reference
Dose
(
39
mg/
kg/
day)
is
protective
of
the
precursor
events
leading
to
development
of
bladder
tumors
that
occur
at
doses
above
200
mg/
kg/
day
and
liver
tumors
that
occur
above
500
mg/
kg/
day.

3.2
Dose­
Response
Assessment
On
October
20,
2004,
the
Antimicrobials
Division
Toxicology
Endpoint
Selection
Committee
(
ADTC)
reviewed
the
available
toxicology
data
for
OPP
and
selected
endpoints
for
use
as
appropriate
in
occupational/
residential
exposure
risk
assessments.
The
potential
for
increased
susceptibility
of
infants
and
children
from
exposure
to
OPP
was
also
evaluated
by
the
committee
in
order
to
meet
the
statutory
requirements
of
the
Food
Quality
Protection
Act
(
FQPA)
of
1996.
A
summary
of
the
results
are
presented
in
Table
3­
2.

Table
3­
2
Summary
of
Toxicological
Doses
and
Endpoints
for
Orthophenylphenol
for
Use
in
Human
Risk
Assessments
Exposure
Scenario
Dose
Used
in
Risk
Assessment
(
mg/
kg/
day)
Target
MOE,
UF,
Special
FQPA
SF,
for
Risk
Assessment
Study
and
Toxicological
Effects
Dietary
Risk
Assessments
Acute
Dietary
(
general
population
and
females
13­
49)
No
appropriate
endpoints
were
identified
that
represent
a
single
dose
effect.
Therefore,
this
risk
assessment
is
not
required.

Chronic
Dietary
(
all
populations)
NOAEL
=
39
mg/
kg/
day
(
43%
dermal
absorption)
FQPA
SF
=
1
UF
=
100
(
10x
inter­
species
extrapolation,
10x
intra­
species
variation)

Chronic
RfD
=
0.39
mg/
kg/
day
Chronic
PAD
=
0.39
mg/
kg/
day
Combined
oral
toxicity/
carcinogenicity
study
in
rats
(
MRID
43954301,
44852701,
44832201)

LOAEL
of
200
mg/
kg/
day
based
upon
decreased
body
weight,
body
weight
gain,
food
consumption
and
food
efficiency,
increased
clinical
and
gross
pathological
signs
of
toxicity.

Non­
Dietary
Risk
Assessments
Incidental
Oral
Short­
Term
(
1
­
30
days)
NOAEL
(
maternal)
=
100
mg/
kg/
day
Target
MOE
=
100
FQPA
SF
=
1
UF
=
100
(
10x
inter­
species
extrapolation,
10x
intra­
species
Developmental
(
gavage)
toxicity
studies
in
rats
(
MRID
00067616,
92154037)
and
rabbits
(
MRID
41925003;
co­
critical
developmental
toxicity
study)

Maternal
LOAEL
of
300
mg/
kg/
day
Page
20
of
60
Table
3­
2
Summary
of
Toxicological
Doses
and
Endpoints
for
Orthophenylphenol
for
Use
in
Human
Risk
Assessments
Exposure
Scenario
Dose
Used
in
Risk
Assessment
(
mg/
kg/
day)
Target
MOE,
UF,
Special
FQPA
SF,
for
Risk
Assessment
Study
and
Toxicological
Effects
variation)
based
upon
clinical
observations
of
toxicity,
decreased
weight
gain,
food
consumption
and
food
efficiency
observed
in
the
rat
developmental
toxicity
study.

Incidental
Oral
Intermediate­
Term
(
1
­
6
months)
NOAEL
=
39
mg/
kg/
day
Target
MOE
=
100
FQPA
SF
=
1
UF
=
100
(
10x
inter­
species
extrapolation,
10x
intra­
species
variation)
Combined
oral
toxicity/
carcinogenicity
study
in
rats
(
MRID
43954301,
44852701,
44832201)

LOAEL
of
200
mg/
kg/
day
based
upon
decreased
body
weight,
body
weight
gain,
food
consumption
and
food
efficiency,
increased
clinical
and
gross
pathological
signs
of
toxicity.

Dermal
Short­
Term
(
1
­
30
days)

(
residential
and
occupational)
NOAEL
(
dermal)
=
100
mg/
kg/
day
(
200
µ
g/
cm2)
a
Target
MOE
=
100
FQPA
SF
=
1
UF
=
100
(
10x
inter­
species
extrapolation,
10x
intra­
species
variation)
21­
Day
Dermal
toxicity
study
in
rats
(
MRID
42881901)

LOAEL
(
dermal)
of
500
mg/
kg/
day
based
upon
dermal
irritation
(
erythema,
scaling)
at
the
site
of
test
substance
application.

Dermal
Intermediate­
and
Long­
Term
(
1
­
6
months
and
>
6
months)

(
residential
and
occupational)
NOAEL
=
39
mg/
kg/
dayb
Target
MOE
=
100
FQPA
SF
=
1
UF
=
100
(
10x
inter­
species
extrapolation,
10x
intra­
species
variation)
Combined
oral
toxicity/
carcinogenicity
study
in
rats
(
MRID
43954301,
44852701,
44832201)

LOAEL
of
200
mg/
kg/
day
based
upon
decreased
body
weight,
body
weight
gain,
food
consumption
and
food
efficiency
(
effects
observed
as
early
as
13
weeks
in
this
study),
increased
clinical
and
gross
pathological
signs
of
toxicity.

Inhalation
Short­
Term
(
1
­
30
days)

(
residential
and
occupational)
NOAEL
(
maternal)
=
100
mg/
kg/
dayc
Target
MOE
=
100
FQPA
SF
=
1
UF
=
100
(
10x
inter­
species
extrapolation,
10x
intra­
species
variation)
Note:
an
additional
10x
is
necessary
for
route
extrapolation.
If
results
are
below
a
MOE
of
1,000,
a
Developmental
(
gavage)
toxicity
studies
in
rats
(
MRID
00067616,
92154037)
and
rabbits
(
MRID
41925003;
co­
critical
developmental
toxicity
study)

Maternal
LOAEL
of
300
mg/
kg/
day
based
upon
clinical
observations
of
toxicity,
decreased
weight
gain,
food
consumption
and
food
efficiency
observed
in
the
rat
developmental
toxicity
study.
Page
21
of
60
Table
3­
2
Summary
of
Toxicological
Doses
and
Endpoints
for
Orthophenylphenol
for
Use
in
Human
Risk
Assessments
Exposure
Scenario
Dose
Used
in
Risk
Assessment
(
mg/
kg/
day)
Target
MOE,
UF,
Special
FQPA
SF,
for
Risk
Assessment
Study
and
Toxicological
Effects
confirmatory
inhalation
study
may
be
required
Inhalation
Intermediate­
and
Long­
Term
(
1
­
6
months
and
>
6
months)

(
residential
and
occupational)
NOAEL
=
39
mg/
kg/
dayc
Target
MOE
=
100
FQPA
SF
=
1
UF
=
100
(
10x
inter­
species
extrapolation,
10x
intra­
species
variation)
Note:
an
additional
10x
is
necessary
for
route
extrapolation.
If
results
are
below
a
MOE
of
1,000,
a
confirmatory
inhalation
study
may
be
required
Combined
oral
toxicity/
carcinogenicity
study
in
rats
(
MRID
43954301,
44852701,
44832201)

LOAEL
of
200
mg/
kg/
day
based
upon
decreased
body
weight,
body
weight
gain,
food
consumption
and
food
efficiency
(
effects
observed
as
early
as
13
weeks
in
this
study),
increased
clinical
and
gross
pathological
signs
of
toxicity.

Cancer
(
oral,
dermal,
inhalation)
Classification:
Orthophenylphenol
is
classified
as
A
Not
likely
to
be
carcinogenic
below
a
specific
dose
range
@,
without
quantification
of
risk.

UF
=
uncertainty
factor,
DB
UF
=
data
base
uncertainty
factor,
FQPA
SF
=
special
FQPA
safety
factor,
NOAEL
=
no
observed
adverse
effect
level,
LOAEL
=
lowest
observed
adverse
effect
level,
PAD
=
population
adjusted
dose
(
a
=
acute,
c
=
chronic),
RfD
=
reference
dose,
MOE
=
margin
of
exposure
a
(
100mg
x
0.200
kg
rat
x
1000
µ
g
)
/
100
cm2
area
of
rat
dose
=
200
µ
g/
cm2
Kg
rat
mg
b
A
dermal
absorption
factor
of
43%
was
chosen
based
on
the
results
of
a
submitted
study
(
Timchalk
et
al.,
1996)
in
humans.
c
The
inhalation
absorption
factor
of
100%
(
default
value,
assuming
oral
and
inhalation
absorption
are
equivalent)
is
used
as
an
assumption
since
an
oral
endpoint
was
selected
for
the
inhalation
exposure
scenarios.

3.3
FQPA
Considerations
Developmental
toxicity
studies
for
orthophenylphenol
are
available
in
both
the
rat
and
rabbit,
as
summarized
in
this
toxicology
chapter.
Both
studies
were
well
conducted
and
considered
acceptable
by
the
Agency.
The
examination
of
these
studies
shows
that
adverse
effects
in
offspring
occurred
at
doses
higher
than
those
producing
maternal
toxicity.
In
addition,
the
effects
on
offspring
were
not
considered
more
severe
than
those
occurring
in
maternal
animals.
Therefore,
there
is
no
increased
concern
for
developmental
toxicity
of
orthophenylphenol
when
comparing
effects
in
adult
animals
with
those
in
offspring.
This
conclusion
is
similar
to
that
reached
by
the
Department
for
Page
22
of
60
Environment,
Food
and
Rural
Affairs
of
the
Pesticides
Safety
Directorate
in
their
1993
publication
on
the
evaluation
of
2­
phenylphenol.

An
acceptable
two­
generation
reproduction
toxicity
study
conducted
according
to
Agency
guidelines
is
available
for
orthophenylphenol.
There
were
no
toxicologically
significant
effects
on
reproductive
parameters
in
this
study.
Therefore,
there
is
no
increased
concern
for
potential
reproductive
toxicity
of
orthophenylphenol.

Based
on
the
above,
the
ADTC
recommended
that
the
special
hazard­
based
FQPA
safety
factor
be
reduced
to
1x
for
OPP.
There
are
available
developmental
toxicity
and
reproductive
toxicity
studies
for
OPP
that
are
considered
acceptable
and
that
show
no
evidence
of
increased
toxicity
to
offspring
at
the
same
or
lower
doses
as
those
causing
parental/
systemic
toxicity
or
evidence
of
more
severe
toxicity
relative
to
parental/
systemic
toxicity.

3.4
Endocrine
Disruption
EPA
is
required
under
the
Federal
Food
Drug
and
Cosmetic
Act
(
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
was
scientific
basis
for
including,
as
part
of
the
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
has
authority
to
require
the
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
Agency's
EDSP
have
been
developed,
OPP
may
be
subjected
to
additional
screening
and/
or
testing
to
better
characterize
effects
related
to
endocrine
disruption.

4.0
EXPOSURE
ASSESSMENT
AND
CHARACTERIZATION
4.1
Summary
of
Registered
Antimicrobial
Uses
Table
4­
1
presents
the
uses
of
OPP
and
OPP
salts
that
represent
the
high
end
exposures
and
risks
associated
with
the
labeled
uses.
Some
OPP
and
OPP
salts
are
registered
for
residential
uses
such
as
disinfectants
and
deodorizers.
The
use
patterns
for
these
include
indoor
and
outdoor
hard
surfaces
(
e.
g.,
floors,
bathroom
fixtures,
trash
cans,
household
contents),
textiles
(
e.
g.,
clothing,
diapers,
and
bedding)
and
carpets.
Additional
uses
include
fogging
and
air
deodorizing
and
also
as
material
preservative
for
homeowner
Page
23
of
60
type
products
(
e.
g.,
plastics
and
paints,
metalworking
fluids,
sapstain,
glues,
paper,
polymers,
and
paper).
The
percentage
of
OPP
and
OPP
salts
in
various
products
range
from
0.0137%
to
99.5%.

The
routes
of
exposure
evaluated
in
the
present
assessment
are:
short­
term
(
ST),
intermediate­
term
(
IT),
and
long­
term
(
LT)
dermal
and
inhalation
exposures,
and
shortterm
(
ST)
and
intermediate­
term
(
IT)
oral
exposures.
Specific
routes
and
durations
are
also
presented
in
Table
4­
1.

Table
4­
1
Representative
Uses
Associated
with
Residential
Exposure
Representative
Use
Exposure
Scenario
Application
Method
Registration
#
Application
Rate
ST
Handler:
Dermal
and
Inhalation;

ST
and
IT
Post­
app1,9:
child
incidental
ingestion
and
dermal
Mopping
ST
Handler:
Dermal
and
Inhalation
Wiping
40510­
5
(
OPP
Salt)
0.126
lb
a.
i./
diluted
gal
(
8
oz.
product
/
4
gal
water
x
97%
a.
i.
x
8.34
lb/
gal
x
1
gal/
128
oz)
Indoor
Hard
Surfaces
ST
Handler:
Dermal
and
Inhalation
Aerosol
foam
spray3
777­
27
(
OPP)
0.42%
a.
i.
by
weight
Outdoor
Hard
Surfaces
(
i.
e.
exterior
house
cleaner)
ST
Loader
and
Handler:
Dermal
and
Inhalation
Tank
type
garden
sprayer
(
i.
e.
low
pressure
sprayer)
71240­
1
(
OPP
Salt)
0.00104
lb
a.
i./
gal
(
0.25
gal
product
/
5
gal
water
x
0.25%
a.
i.
x
8.34
lb/
gal:
assuming
product
has
the
density
of
water)

Textiles
(
i.
e.,
clothing
and
cloth
diapers)
ST
Handler:
Dermal
and
Inhalation
ST
Post­
app:
adult
dermal;
child
incidental
ingestion
and
dermal
IT/
LT
Post­
app:
child
dermal
(
diaper)
Trigger
pump
spray3
10088­
105
(
OPP)
0.0208
lb
ai/
gal
(
0.249%
ai
x
8.34
lb/
gal)

Air
Deodorization
ST
Handler:
Dermal
and
Inhalation
Post­
app:
adult
(
ST)
and
child
(
ST
and
IT)
1
inhalation
2
Aerosol
spray
44446­
67
(
OPP)
0.199%
a.
i.
by
weight
Page
24
of
60
Table
4­
1
Representative
Uses
Associated
with
Residential
Exposure
Representative
Use
Exposure
Scenario
Application
Method
Registration
#
Application
Rate
Fogging
ST
Post­
app:
adult
and
child
inhalation
(
vapor)
8
Fogger
70263­
3
5
(
OPP)
0.019
lb
a.
i./
6000
ft2
(
0.22%
a.
i.
x
1
gal
product/
6000
ft2
x
8.34
lb/
gal)

Using
Treated
Plastic/
polymer
products
(
i.
e.,
toys)
ST
Post­
app:
child
incidental
ingestion
NA
67869­
24
(
OPP
salt)
0.34%
a.
i.
by
weight
of
material
to
be
preserved
Using
Treated
Paint
ST
Handler:
Dermal
and
Inhalation
(
aerosol
and
vapor)
6
ST
Post­
app:
adult
and
child
inhalation
(
vapor)
7
Paint
brush,
rollers,
airless
sprayer
67869­
24
(
OPP
salt)

and
464­
126
(
OPP)
0.56%
a.
i.
by
weight
of
material
to
be
preserved
0.5%
a.
i.
by
weight
of
material
to
be
preserved
ST
=
Short­
term
exposure,
IT
=
Intermediate­
term
exposure
1IT
post­
application
exposures
for
children
were
assessed
because
that
this
product
could
be
used
in
a
commercial
day
care
facility.
2
Since
this
application
rate
is
for
OPP,
which
has
a
relatively
high
vapor
pressure,
it
was
necessary
to
assess
post­
application
inhalation
exposure
to
the
vapor.
OPP
salts
have
a
much
lower
vapor
pressure
and
will
not
readily
volatilize.
3
The
aerosol
spray
was
chosen
to
represent
the
aerosol
foam
product
and
trigger
pump
spray
product
because
it
is
expected
that
they
have
similar
unit
exposures.
4
The
post­
app
exposure
is
represented
by
the
post­
app
exposure
scenario
for
air
deodorization.
5
Label
Reg
#
70263­
3
can
be
used
in
household
settings
by
commercial
applicators;
therefore,
a
postapplication
scenario
was
assessed
using
the
%
ai
from
this
product.
However,
the
application
rate
from
another
label
(#
65020­
7)
for
lack
of
better
data.
Note:
Reg
#
65020­
7
also
can
be
used
in
schools.
6
Handler
dermal
and
inhalation
(
to
the
particulates)
exposure
were
assessed
for
OPP
salts
using
PHED
unit
exposures.
WPEM
(
Wall
Paint
Exposure
Model)
was
also
used
to
assess
the
vapors
of
OPP
for
residential
handlers
because
of
the
high
vapor
pressure
of
OPP.
7
Post­
application
inhalation
exposures
to
the
vapor
were
assessed
for
only
the
OPP
product
because
of
its
high
vapor
pressure.
8
For
the
fogging
scenario,
child
post­
application
incidental
ingestion
or
dermal
exposures
were
not
assessed
because
they
were
assessed
for
the
mopping
application.
The
mopping
application
has
a
much
higher
application
rate
(
in
terms
of
lb
ai/
ft2)
than
the
fogging
application.
It
should
also
be
noted
that
although
the
fogging
application
can
occur
in
child
care
facilities,
the
intermediate­
term
duration
was
not
assessed
because
it
was
assumed
that
the
fogging
application
would
be
used
primarily
in
areas
damaged
by
smoke,
fire,
floods,
or
sewage
backups
and
these
incidents
do
not
occur
on
a
continuous
basis.
9This
label,
#
40510­
5
states
that
the
product
can
be
used
for
"
housekeeping
santization"
and
to
"
sanitize
latrine:
buckets,
urinals,
toilet
bowls,
walls,
shower
stalls,
garbage
cans,
and
garbage
platforms."
This
is
why
it
is
assumed
to
not
be
used
in
daycares.
It
does
not
specifically
say
"
commercial
and
institutional
premises."

4.1.1
Residential
Exposure/
Risk
The
residential
handler
scenarios
shown
in
Table
4­
2
were
assessed
to
determine
dermal
and
inhalation
exposures.
The
majority
of
the
scenarios
were
assessed
using
CMA
data.
However,
for
handlers
using
paint,
two
approaches
were
used
to
determine
inhalation
Page
25
of
60
exposure.
First,
the
Pesticides
Handler
Exposure
Database
(
PHED)
was
used
to
determine
inhalation
exposure
to
aerosolized
particles
of
paint
(
assessed
below).
Secondly,
to
assess
the
inhalation
exposure
to
OPP
vapor,
EPA's
Wall
Paint
Exposure
Model
(
WPEM)
was
used.
For
specific
assumptions
used
in
this
analysis,
consult
the
Occupational
and
Residential
Exposure
chapter
for
OPP.

Handlers
The
resulting
short­
term
dermal
and
aerosol
portion
of
the
inhalation
exposures
and
MOEs
for
the
representative
residential
handler
scenarios
are
presented
in
Table
4­
2.
The
calculated
MOEs
were
above
the
target
dermal
and
inhalation
MOE
of
100
for
all
scenarios.
Furthermore,
all
short­
term
inhalation
MOEs
exceeded
1,000
therefore,
a
confirmatory
inhalation
toxicity
study
is
not
warranted
based
on
the
results
of
these
exposure
scenarios.

Table
4­
2
Short­
Term
OPP
&
Salts
Residential
Handlers
Exposures
and
MOEs
Unit
Exposure
(
mg/
lb
ai)
Absorbed
Daily
Dose
(
mg/
kg/
day)
MOE
(
ST)

Exposure
Scenario
Method
of
Application
Dermala
Inhalation
Application
Rate
Quantity
Handled/
Treated
per
day
Dermalb
Inhalationc
Dermal
(
Target
=
100)
d
Inhalation
(
Target
=
100)
e
Mopping
71.6
2.38
0.126
lb
ai/
gallon
1
gallons
0.1289
0.0043
780
23,000
Wiping
2870
67.3
0.126
lb
ai/
gallon
0.13
gallons
0.6716
0.0157
150
6,300
Application
to
indoor
hard
surfaces
Aerosol
Foam
Spray
220
2.4
0.42
%
ai
by
weight
0.875
lbs
0.0116
0.0001
8,700
7.90x105
Application
to
outdoor
hard
surfaces
(
i.
e.
exterior
of
homes)
Tank
Type
Low
Pressure
Garden
Sprayer
100
0.03
0.00104
lb
ai/
gallon
5
gallons
0.01
0.00016
13,000
4.5x107
Application
to
textiles
Trigger
Pump
Spray
220
2.4
0.0208
lb
ai/
gallon
0.13
gallons
0.085
0.0065
12,000
1.10x106
Air
deodorization
Aerosol
Spray
220
2.4
0.199%
ai
by
weight
1.03
lbs
0.0064
7.5
x
10­
5
16,000
1.4
x106
Brush/
roller
230
0.284
0.56%
ai
by
weight
20
lb
s
(
2
gal)
0.368
0.0005
270
220,000
Painting
Airless
sprayer
79
0.83
0.56%
ai
by
weight
150
lbs
(
15
gal)
0.948
0.01
110
10,000
a
All
dermal
unit
exposures
represent
ungloved
replicates.
The
aerosol
spray,
tank­
type
garden
sprayer
(
i.
e.,
low
pressure
sprayer),
trigger
pump
sprayer,
brush/
roller,
and
airless
sprayer
unit
exposures
represent
short
sleeve
and
short
pant
replicates.
The
mopping,
wiping,
and
liquid
pour
represent
long
pant
and
long
shirt
replicates.
b
Dermal
Daily
Dose
(
mg/
kg/
day)
=
[
dermal
unit
exposure
(
mg/
lb
ai)
*
application
rate
*
quantity
handled
/
body
weight
(
70
kg).
Page
26
of
60
c
Inhalation
Daily
Dose
(
mg/
kg/
day)
=
[
inhalation
unit
exposure
(
mg/
lb
ai)
*
application
rate
*
quantity
handled
/
body
weight
(
70
kg).
d
Dermal
MOE
=
NOAEL
(
100
mg/
kg/
day)
/
Daily
Dose.
Target
dermal
MOE
is
100.
e
Inhalation
MOE
=
NOAEL
(
100
mg/
kg/
day)
/
Daily
Dose.
Target
inhalation
MOE
is
100.

Residential
Painter
Inhalation
Exposure
and
Risk
For
assessment
of
the
vapor
portion
of
the
inhalation
exposure
of
residential
painters,
AD
utilized
EPA's
Wall
Paint
Exposure
Model
(
WPEM)
version
3.2
to
estimate
air
concentrations
resulting
from
the
use
of
paint
preserved
with
OPP.
WPEM
was
developed
under
a
contract
by
Geomet
Technologies
for
EPA
OPPT
to
provide
estimates
of
potential
air
concentrations
and
consumer/
worker
exposures
to
chemicals
emitted
from
wall
paint
which
is
applied
using
a
roller
or
a
brush.
WPEM
uses
mathematical
models
developed
from
small
chamber
data
to
estimate
the
emissions
of
chemicals
from
oilbased
(
alkyd)
and
latex
wall
paint.
The
emission
data
can
then
be
combined
with
detailed
use,
workload
and
occupancy
data
(
e.
g.,
amount
of
time
spent
in
the
painted
room,
etc,)
to
estimate
exposure.
Specific
input
parameters
include:
the
type
of
paint
(
latex
or
alkyd)
being
assessed,
density
of
the
paint
(
default
values
available),
and
the
chemical
weight
fraction,
molecular
weight,
and
vapor
pressure.
Detailed
information
and
the
executable
model
can
be
downloaded
from
http://
www.
epa.
gov/
opptintr/
exposure/
docs/
wpem.
htm.

Results
of
the
WPEM
model
calculated
the
short­
term
vapor
inhalation
MOE
as
2,000,
which
does
not
present
a
risk
of
concern
for
inhalation
exposure
of
residential
painters.

Residential
Post­
Application
For
the
purposes
of
this
screening
level
assessment,
post­
application
scenarios
have
been
developed
that
encompass
multiple
products,
but
still
represent
a
high
end
exposure
scenario
for
all
products
represented.
As
shown
in
Table
4­
1,
representative
postapplication
scenarios
assessed
include
contacting
treated
hard
surfaces/
floors
(
dermal
and
incidental
oral
exposure
to
children),
wearing
treated
clothing
(
dermal
exposure
to
adults
and
children),
wearing
treated
diapers
(
dermal
exposure
to
infants),
mouthing
treated
textiles
such
as
clothing
and
blankets
(
incidental
oral
exposure
to
children),
and
mouthing
treated
plastic
toys
(
incidental
oral
exposure
to
infants).
Additionally,
postapplication
bystander
inhalation
exposures
were
assessed
for
use
of
the
disinfecting/
deodorizing
products
(
vapor
exposure
to
adults
and
children)
and
paints
(
vapor
exposure
to
adults
and
children).
Typically,
most
products
used
in
a
residential
setting
result
in
exposures
occurring
over
a
short­
term
time
duration
(
1
to
30
days).

There
is
the
potential
for
dermal
exposure
to
toddlers
crawling
on
hard
floors
after
mopping
with
OPP
and
OPP
salts
products.
Exposures
and
MOEs
were
calculated
for
children
contacting
treated
hard
surface
floors
in
residential
homes
(
short­
term
exposure)
and
in
commercial
daycare
centers
(
intermediate­
term
exposure).
The
dermal
MOEs
for
the
residential
settings
(
short­
term
MOE)
and
institutional
settings
(
intermediate­
term
MOE)
are
above
the
target
MOE
of
100.
In
addition
to
the
dermal
exposure,
toddlers
crawling
on
treated
hard
floors
will
also
be
exposed
to
OPP
and
OPP
salts
residues
via
Page
27
of
60
incidental
oral
exposure
through
hand­
to­
mouth
activity.
To
calculate
incidental
ingestion
exposure
to
these
chemicals
due
to
hand­
to­
mouth
transfer,
the
methodologies
established
in
the
Standard
Operating
Procedures
(
SOPs)
for
Residential
Exposure
Assessments
(
USEPA
2000
and,
2001)
were
used.
These
use
assumptions
that
are
similar
to
those
used
in
calculating
dermal
exposures
for
toddlers
crawling
on
treated
hard
floors.
Exposures
were
calculated
for
children
contacting
treated
floors
in
residential
homes
and
in
commercial
day
care
centers.
The
oral
MOEs
are
above
the
target
MOE
of
100
for
residential
settings
and
institutional
settings,
and
thus
do
not
present
a
risk.

The
calculation
of
the
short­
and
intermediate­
term
dermal
and
oral
doses
and
the
dermal
and
oral
MOEs
are
shown
in
Table
4­
3
and
4­
4
respectively.

Table
4­
3.
Short­
and
Intermediate­
term
Post­
application
Dermal
Exposures
and
MOEs
for
Children
Contacting
Treated
Floors
Exposure
Scenario
Application
Rate
(
lb
ai/
sq
ft)
Product
remaining
after
mopping
Percent
Trans.
Residue
Body
Area
in
contact
with
floor
(
m2)
Absorbed
potential
daily
dosea
(
mg/
kg/
day)
Dermal
MOEb
Hard
surfaces
­
residential
setting
1.26x10­
4
25%
10%
0.657
0.674
150
(
ST)

Hard
surfaces
­
daycare
center
1.83x10­
5
25%
10%
0.657
0.0421
930
(
IT)

a
Absorbed
Potential
Daily
Dose(
mg/
kg/
day)
=
[(
Application
rate,
lb
ai/
ft2)*(
conversion
factor,
454
g/
lb)*
(
conversion
factor,
1,000
mg/
g)
*
(
conversion
factor,
1
ft2/
0.093
m2)
*
(
product
remaining
after
mopping,
25%)
*
(
dermal
transfer
factor,
10%)
*
(
body
surface
area
in
contact
with
floor,
0.657
m2)
*
(
dermal
absorption
,
0.43
for
IT
exposure
and
not
applicable
for
ST
exposures)
]
/
(
body
weight,
15
kg)
b
Dermal
MOE
=
NOAEL
(
mg/
kg/
day)
/
Absorbed
Potential
Daily
Dose
(
mg/
kg/
day)
[
Where
short­
term
dermal
NOAEL
=
100
mg/
kg/
day
and
intermediate­
term
dermal
NOAEL
=
39
mg/
kg/
day].
Target
MOE
=
100
Table
4­
4.
Short­
and
Intermediate­
term
Incidental
Oral
Post­
application
Exposures
and
MOEs
for
Children
Contacting
Treated
Floors
Exposure
Scenario
Appl.
Rate
(
lb
ai/
sq
ft)
Product
remaining
after
mopping
Surface
Residuea
(
µ
g/
cm2)
Percent
transferable
residue
Surface
area
mouthed
(
cm2/
event)
Exposure
Frequency
(
events/
hr)
Saliva
Extraction
Factor
Exp.
Time
(
hrs/
day)
Absorbed
Potential
Daily
Doseb
(
mg/
kg/
day)
Oral
MOEc
Hard
surfaces
­
residential
setting
1.26x10­
4
25%
15.45
10%
20
20
50%
4
0.0824
1,200
(
ST)

Hard
surfaces
­
daycare
center
1.83x10­
5
25%
2.24
10%
20
9.5
50%
4
0.0057
6,900
(
IT)

a
Surface
residue
(
µ
g/
cm2)
=
(
application
rate,
lb
ai/
ft2)*(
Disinfectant
fraction
remaining
on
floor,
0.25)*(
conversion
factor
to
convert
lb
to
µ
g,
4.54E+
08
µ
g/
lb)*(
conversion
factor
to
convert
ft2
to
cm2,
1.08E­
03
ft2/
cm2)
b
Absorbed
Potential
Daily
Dose
(
mg/
kg/
day)
=
[(
Surface
residue,
µ
g/
cm2)*(
transferable
residue,
0.10)*(
exposure
time,
4
hrs/
day)*(
surface
area
of
hands,
20
cm2/
event)*(
frequency
of
hand­
to­
mouth
Page
28
of
60
activity,
20
events/
hr,
and
9.5
event
for
intermediate
term)*(
extraction
by
saliva,
50
%)*(
conversion
factor
to
convert
µ
g
to
mg,
0.001
mg/
µ
g)]/(
body
weight,
15
kg)
c
MOE
=
NOAEL
(
mg/
kg/
day)
/
absorbed
potential
daily
dose(
mg/
kg/
day)
[
Where
short­
term
oral
NOAEL
=
100
mg/
kg/
day
and
intermediate­
term
NOAEL
=
39
mg/
kg/
day].
Target
MOE
=
100.

For
the
intermediate­
term
exposures
to
the
treated
floors,
it
was
necessary
to
determine
Total
MOEs
since
the
toxicity
effects
are
the
same
for
the
dermal
and
oral
routes.
The
intermediate­
term
Total
MOE
for
children
contacting
treated
floors
in
day
care
facilities
was
820
and
is
greater
than
the
target
MOE
of
100.

Dermal
exposure
from
treated
clothing
There
is
the
potential
for
dermal
exposure
to
adults
and
children
from
wearing
clothing
treated
with
a
trigger­
pump
spray
product
containing
OPP
or
treatment
via
factory
impregnation
of
the
chemical
as
a
preservative.
Even
as
there
is
anticipated
exposure
to
result
from
an
already
preserved
textile,
the
trigger­
pump
use
was
identified
to
be
the
high
end,
and
ultimately
was
the
one
assessed.
(
See
Table
4­
5)

Table
4­
5.
Dermal
Post­
application
Exposures
and
MOEs
for
Children
and
Adults
Contacting
Treated
Textiles
%
a.
i.
Product
absorption
rate
(
mg/
cm2)
Conc.
on
clothinga
(
mg
ai/
cm2)
Surface
area
covered
by
textile
(
cm2/
day)
Percent
transferred
Exposure
time
Potential
daily
doseb
(
mg/
kg/
day)
Dermal
MOEc
Short­
Term
Wearing
Treated
Clothing
­
Children
100%
16
(
hours/
day)
124.24
<
1
0.249
198
0.493
5,670
5%
16
(
hours/
day)
6.21
16
Short­
Term
Wearing
Treated
Clothing
 
Adults
100%
16
(
hours/
day)
79.34
1
0.249
198
0.493
16,900
5%
16
(
hours/
day)
3.97
25
Wearing
Treated
Diapers
­
<
1
year
old
100%
8
diapers/
day
182.2
(
ST)
78.35
(
IT/
LT)
<
1
(
ST)
<
1
(
IT/
LT)
0.249
198
0.493
462
5%
8
diapers/
day
9.11
(
ST)
3.92
(
IT/
LT)
11
(
ST)
10
(
IT/
LT)

a
Concentration
on
clothing
(
mg/
cm2)
=
%
active
ingredient
/
100
*
Product
absorption
rate
(
198
mg/
cm2)
b
Potential
Daily
Dose
for
clothing
(
mg/
kg/
day)
=
[(
concentration
on
clothing,
mg/
cm2)
*
(
surface
area
of
skin
covered
by
clothing,
cm2/
day)
*
(
percent
transferable
residue
from
textile)
*
(
exposure
time,
hrs/
day)
*
(
conversion
factor,
1
day/
24
hours)]
/
(
body
weight,
kg).
Potential
Daily
Dose
for
diapers
(
mg/
kg/
day)
=
[(
concentration
on
diapers,
mg/
cm2)
*
(
surface
area
covered
by
diaper,
cm2/
diaper)
*
(
exposure
frequency,
diapers/
day)
*
(
dermal
absorption
Page
29
of
60
factor,
0.43
for
IT,
not
applicable
for
ST)
*
(
percent
transferable
residue
from
diapers)]
/
(
body
weight,
kg)
c
MOE
=
NOAEL
(
mg/
kg/
day)
/
absorbed
potential
daily
dose
[
Where
short­
term
dermal
NOAEL
=
100
mg/
kg/
day
and
IT/
LT
dermal
NOAEL
=
39
mg/
kg/
day].
Target
MOEs
=
100.

The
dermal
MOEs
for
children
are
below
the
target
MOE
of
100
using
the
100%
transfer
factor
(
MOE
<
1)
and
using
the
5%
transfer
factor
(
MOE
=
16).
For
adults,
the
dermal
MOEs
are
also
below
the
target
MOE
of
100
using
both
the
100%
transfer
factor
(
MOE
=
1)
and
the
5%
transfer
factor
(
MOE
=
25).

For
infants
wearing
treated
cloth
diapers,
all
MOEs
were
below
the
target
MOE
of
100
when
using
a
transfer
factor
of
either
100%
or
5%,
and
therefore,
are
of
concern.

Incidental
Oral
Exposure
to
Children
Mouthing
Treated
Textiles
There
is
the
potential
for
incidental
oral
exposure
to
children
from
mouthing
textiles
treated
with
a
trigger­
pump
spray
product
containing
OPP.
The
calculation
of
the
oral
dose
and
oral
MOE
for
children
mouthing
treated
textiles
shows
that
the
MOE
value
is
above
the
target
MOE
of
100
(
MOE
=
300).
The
results
are
presented
in
Table
4­
6.

Table
4­
6.
Short­
term
Post­
application
Incidental
Oral
Exposures
and
MOEs
for
Children
Contacting
Treated
Textiles
%
a.
i.
Product
absorption
rate
(
mg/
cm2)
Concentration
on
clothinga
(
mg/
cm2)
Area
mouthed
(
cm2/
day)
Saliva
Extraction
Factor
Potential
daily
dose
(
mg/
kg/
day)
Incidental
Oral
MOEc
0.249
198
0.493
20
50%
0.329
300
a
Concentration
on
clothing
(
mg
ai/
cm2)
=
%
active
ingredient
*
Product
absorption
rate
(
198
mg/
cm2)
b
Potential
Daily
Dose
(
mg/
kg/
day)
=
(
Concentration
on
clothing,
mg/
cm2)
*
(
area
mouthed,
cm2/
day)
*
(
saliva
extraction
factor,
unitless
fraction)
/
(
body
weight,
kg).
c
MOE
=
NOAEL
(
mg/
kg/
day)
/
absorbed
potential
daily
dose
[
Where
short­
term
oral
NOAEL
=
100
mg/
kg/
day].
Target
MOE
=
100.

Incidental
Oral
Exposure
to
Children
from
Mouthing
Treated
Plastic
Toys
The
exposure
estimates
for
children
mouthing
treated
toys
are
based
on
the
methodology
used
for
Microban
Additive
"
B"
assessment
(
USEPA
1997b),
which
assessed
risks
to
12
month
old
infants
playing
with
treated
toys,
and
exposure
assumptions
from
HED's
Residential
SOPs
(
USEPA,
2000
and
2001).
The
calculations
of
the
oral
dose
and
MOE
for
children
mouthing
treated
toys
are
presented
in
Table
4­
7.
The
MOE
is
above
the
target
MOE
of
100
(
MOE
=
2400)
and
thus
present
no
risk
of
concern.
Page
30
of
60
Table
4­
7
Short­
term
Incidental
Oral
Exposures
and
MOEs
for
Infants
Mouthing
Treated
Toys
%
ai
Weight
of
toy
(
g)
Percent
additive
available
at
surface
of
the
toy
(%)
Surface
area
of
toy
(
cm2)
Surface
Residue
a
(
mg
ai/
cm2)
Saliva
Extraction
Factor
Surface
area
of
toy
mouthed
(
cm2/
day)
Absorbed
potential
Daily
Dose
b
(
mg/
kg/
day)
Incidental
Oral
MOE
c
0.34%
50
0.5%
500
0.0017
50%
500
0.0425
2400
a
Surface
Reside
(
mg
ai
for
a
500
cm2
toy)
=
(%
ai)
*
(
Weight
of
toy,
50
g)
*
(
Conversion
factor,
1000
mg/
g)
*
(
Additive
available
at
surface
of
toy,
0.5%)
/
(
Surface
area
of
toy,
500
cm2)
b
Potential
Daily
Dose
(
mg/
kg/
day)
=
Surface
residue
(
0.0017
mg
ai/
cm2)
*
(
toy
area
mouthed,
500
cm2/
day)
*
(
saliva
extraction)
/(
body
weight,
15
kg)
c
MOE
=
NOAEL
(
mg/
kg/
day)
/
potential
daily
dose
(
mg/
kg/
day)
[
Where
short­
term
oral
NOAEL
=
100
mg/
kg/
day].
Target
MOE
=
100.

Air
Deodorizers
No
post­
application
air
concentration
data
have
been
submitted
for
OPP
products
to
determine
potential
vapor
inhalation
risk.
Therefore,
the
Multi­
Chamber
Concentration
and
Exposure
Model
(
MCCEM
v1.2)
was
used
to
present
a
screening­
level
estimate
of
the
potential
inhalation
risk
to
adults
and
children.
Results
of
the
MCCEM
calculation
are
shown
in
Table
4­
8.
For
both
adults
and
children,
the
calculated
inhalation
MOEs
are
greater
than
100
and
thus
present
no
risk
of
concern.
Furthermore,
these
MOEs
are
also
greater
than
1,000
therefore;
an
additional
inhalation
toxicity
study
is
not
warranted
based
on
the
results
of
this
scenario.

Table
4­
8
Short­
and
Intermediate­
term
Post­
application
Inhalation
Exposures
and
MOEs
for
Adults
and
Children
in
Areas
Treated
With
Air
Deodorizers
Value
Parameter
Adult
Child
Rationale
House*
Generic
House
(
2­
chambers:
35
m3
bedroom,
373
m3
other
rooms)
MCCEM
default
Activity
Schedule*
In
bedroom
at
start
of
modeling,
out
after
8
hours
EPA
Assumption
Concentration
of
product
0.199%
OPP
by
weight
Product
label
#
44446­
67
Quantity
in
Can
168
g
product
Product
label
#
44446­
67
Quantity
Used
per
Day
1.15
g
product
(
2.54x10­
3
lb
product)
Based
on
rate
of
1
can
per
6,000
m3
for
30
days,
and
a
bedroom
size
of
35
m3
Quantity
ai
Used
per
Day
5.06x10­
6
lb
ai/
day
(
2.30x10­
3
g/
day)
(
Quantity
per
day)
*
(
Concentration)

Concentration
in
Bedroom
after
spraying
(
Initial
Concentration
in
6.56x10­
5
g
a.
i./
m3
(
65.6
µ
g
a.
i./
m3)
(
Quantity
ai
per
day)
/
(
Bedroom
volume)
Page
31
of
60
Bedroom)*

Body
Weight*
70
kg
15
kg
Average
body
weights
for
adults
and
young
children
Inhalation
Rate*
11.6
m3/
day
8.88
m3/
day
Average
resting
rate
for
adults
and
young
children
(
USEPA,
1997)

MCCEM
Outputs
Dose
2.67x10­
4
mg/
kg/
day
9.53x10­
4
mg/
kg/
day
MCCEM
Output
Inhalation
short­
term
MOE
370,000
100,000
NOAEL
(
100
mg/
kg/
day)/
Dose
Inhalation
intermediate­
term
MOE
(
day
care
facilities)
NA
41,000
NOAEL
(
39
mg/
kg/
day)/
Dose
Paints
AD
utilized
EPA's
Wall
Paint
Exposure
Model
(
WPEM)
version
3.2
to
estimate
air
concentrations
resulting
from
the
use
of
paint
preserved
with
OPP.
For
this
exposure
assessment,
WPEM
default
scenarios
were
used
to
determine
exposure
to
adults
(
RESADULT)
and
children
(
RESCHILD).
In
these
scenarios,
an
adult
and
child
are
located
in
a
non­
painted
part
of
the
house
while
a
bedroom
is
being
painted
by
a
professional
painter.
For
a
detailed
description
of
the
RESADULT
and
RESCHILD
scenarios,
see
the
WPEM
User's
Guide.
Both
the
child
and
adult
inhalation
MOEs
are
above
the
target
MOE
of
100,
but
below
a
value
of
1,000.
Since
the
MOEs
are
below
1,000,
the
Agency
may
request
that
a
confirmatory
inhalation
toxicity
study
be
conducted.

Table
4­
9
Short­
term
Post­
application
Inhalation
(
vapor)
Exposures
and
MOEs
for
Adult
and
Children
in
Areas
Painted
with
Preserved
Paint
Exposed
Individual
24­
hr
TWA
(
mg/
m3)
a
Exposure
Duration
(
hrs/
day)
Inhal.
Rate
(
m3/
hr)
b
Inhalation
Dose
(
mg/
kg/
day)
c
ST
Inhal.
MOEd
Adult
0.98
24
0.5
0.168
600
Child
1.35
24
0.4
0.867
120
Foggers
Post­
application
inhalation
exposures
were
assessed
for
entry
into
a
room
after
a
fogging
application
was
conducted
using
MCCEM
v1.2.
Results
are
shown
in
the
following
Table
4­
10.
This
table
represents
results
for
various
exposure
durations
immediately
after
the
fogging
(
0
hours)
and
4
hours
after
starting
treatment.
All
of
the
adult
and
child
inhalation
MOEs
were
above
the
target
MOE
of
100.
All
of
the
inhalation
MOEs
for
children
were
below
1,000.
In
addition,
ST
vapor
inhalation
exposures
to
adults
for
a
0­
hr
REI
and
a
4­
and
24­
hour
exposure
duration
along
with
the
ST
vapor
inhalation
exposure
to
adults
for
a
4­
hr
REI
and
24
hour
exposure
duration
were
below
1,000.
Therefore,
the
based
on
the
results
of
these
scenarios
for
which
the
calculated
MOEs
are
Page
32
of
60
below
1,000,
the
Agency
may
request
that
a
confirmatory
inhalation
toxicity
study
be
conducted.

Table
4­
10.
Short­
term
Post­
application
Inhalation
Exposures
and
MOEs
for
Adults
and
Children
in
Fogged
Houses
Re­
Entry
Interval
(
hrs)
Exposure
Duration
(
hrs/
day)
TWA
Air
Conc.
(
mg/
m3)
a
Inhalation
Rate
(
m3/
hr)
b
Inhalation
Dose
(
mg/
kg/
day)
c
ST
Inhal.
MOEd
Adults
2
5.25
0.5
0.075
1,300
4
4.45
0.5
0.127
790
0
24
1.43
0.5
0.245
410
2
2.56
0.5
0.037
2,700
4
2.17
0.5
0.062
1,600
4
24
0.695
0.5
0.119
840
Child
2
5.25
0.4
0.280
360
4
4.45
0.4
0.475
210
0
24
1.43
0.4
0.914
110
2
2.56
0.4
0.136
730
4
2.17
0.4
0.231
430
4
24
0.695
0.4
0.445
230
a
Air
concentrations
calculated
by
MCCEM
using
inputs
described
in
Table
4.11
of
the
Occupational
and
Residential
Exposure
chapter
of
this
RED.
Model
provided
air
concentrations
at
15­
minute
intervals.
Starting
after
the
REI,
the
TWA
was
calculated
for
each
exposure
time
duration
(
See
Appendix
B).
b
Inhalation
rate
is
based
on
sedentary
activity
of
adults
and
young
children
(
USEPA,
1997a)
c
Inhalation
Dose
=
Exposure
Duration
x
TWA
x
Inhalation
Rate
/
Body
Weight
(
70
kg
for
adults,
15
kg
for
children)
d
Short­
Term
Inhalation
MOE
=
Short­
Term
Inhalation
NOAEL
(
100
mg/
kg/
day)
/
Inhal.
Dose
4.2
Dietary
Exposure/
Risk
for
Antimicrobial
Uses
Dietary
risk
assessment
incorporates
both
exposure
and
toxicity
of
a
pesticide.
A
maximum
acceptable
dose
at
which
there
is
no
unreasonable
adverse
health
effects
is
used
for
risk
assessment.
This
dose
is
expressed
as
percent
of
the
population
adjusted
dose
(
PAD).
The
PAD
is
equivalent
to
Reference
Dose
(
RfD)
divided
by
the
special
FQPA
Safety
Factor.
Agency
is
concerned
when
the
estimated
dietary
risks
exceed
100%
of
PAD
(
aPAD
or
cPAD).
For
OPP,
an
acute
toxicological
endpoint
was
not
selected.
Page
33
of
60
The
Agency
has
addressed
out
the
dietary
exposure
and
risk
assessment
for
OPP
and
its
salts
(
sodium
and
potassium).
OPP
and
its
sodium
and
potassium
salts
are
used
as
disinfectants
and
sanitizers
in
the
following
scenarios:

 
Counter
tops
 
Tables
 
Refrigerators
 
Preservative
in
papermaking
 
Preservative
in
adhesive
 
Mushroom
premises
 
Plastics,
polymers
The
uses
of
these
chemicals
as
antimicrobials
in
the
scenarios
shown
above
may
result
in
pesticide
residues
in
human
food.
These
uses
are
considered
indirect
food
uses.

The
maximum
rate
of
application
for
OPP
in
sanitizer
end­
use
solutions
is
400
ppm
as
indicated
in
40CFR
180.940.
Label
searches
indicate
at
the
end­
use
level
application
rates
are
much
higher
than
the
limit
Agency
has
set
in
the
40
CFR.
Hence
we
have
carried
out
the
dietary
assessment
for
all
the
scenarios
listed
above,
except
plastics
and
polymers.
Table
4­
11
summarizes
the
quantitative
risks
evaluated
by
AD
for:
disinfectant
uses
for
counter
tops,
disinfectant
use
for
dish
washing,
slimidice
use
for
pulp
and
paper,
paper
coatings,
and
paper
adhesives.
For
the
remaining
uses,
either
a
quantitative
assessment
was
not
required
or
there
is
data
gap
as
indicated
in
each
subsection.
(
For
detailed
calculations
see
Bob
Quick's
Memo
on
Indirect
Food
Contact
Dietary
Risk
Assessment,
2006)

4.2.1
Mushroom
Houses
There
are
no
EPA
pesticide
tolerances
for
residues
of
OPP
and/
or
NA­
OPP/
K­
OPP
in
mushrooms
(
40CFR
180.129).
Mushrooms
have
not
been
classified
into
any
crop
groupings
under
40
CFR
180.41.
Search
of
USDA
Pesticide
Data
Program
(
PDP)
for
the
monitoring
data
of
years
2001,
2002
and
2003
showed
residues
of
OPP
on
mushrooms
up
to
0.75
ppm
level.
2001
data
showed
the
presence
of
OPP
residues
in
63/
184
samples
(
33%);
2003
data
showed
the
presence
of
residues
in
35/
552
samples
(
6%).
There
is
a
definite
decline
in
the
presence
of
OPP.
However,
the
highest
residues
were
still
at
0.75
ppm.

The
presence
of
OPP/
NA­
OPP/
K­
OPP
in
mushrooms
may
be
due
to
disinfection
of
non­
food
contact
surfaces
in
mushroom
houses,
or
potentially
from
absorption
of
OPP
by
wood
in
the
mushroom
houses.
The
Agency
recommends
that
a
tolerance
for
indirect
residues
of
OPP
and
its
Salts
in
mushrooms
under
40
CFR
180.129
subsection
should
be
established.

4.2.2
Poultry
Hatcheries,
Poultry
Laying
Facilities,
Greenhouse
and
Hydroponic
Uses.
Page
34
of
60
Label
searches
indicate
that
use
of
OPP
products
in
poultry
hatcheries
appear
to
be
non­
food
use.
No
residues
are
expected.
EPA
Reg#
11725­
7
indicates
a
registered
use
for
poultry
laying
operation
but
it
does
not
appear
a
sanitizer
use.
Measurable
residues
would
not
be
expected
to
occur
in
the
egg
from
this
type
of
use.

4.2.3
Greenhouse
and
Hydroponic
Uses
For
greenhouse
and
hydropnic
uses
there
are
label
restrictions
against
applying
to
crop,
soil
or
growing
media
in
which
a
crop
is
grown.
A
potable
rinse
is
recommended
before
treated
surface
contact
crop
or
a
substrate
which
is
likely
to
contact
crop.
The
Agency
recommends
a
confirmatory
data
to
show
whether
OPP
residues
are
absorbed
into
treated
surfaces
and
whether
the
potable
water
rinses
eliminate
the
residues.

4.2.4
Polymers
and
Plastics
Uses
OPP
is
registered
for
use
into
polymers
and
plastics
which
are
likely
to
contact
food
(
EPA
Reg
#:
464­
126),
applied
at
a
rate
of
0.1
to
0.5%.
The
Agency
in
its
database
does
not
have
any
information
about
a
migration
study
on
OPP
migration
into
plastics
and
polymers.
The
Agency
recommends
a
migration
study
should
be
conducted
on
migration
of
OPP
to
food
from
plastics
and
polymers.

4.2.5
Wood
and
Wood
Product
Use.

From
the
language
of
the
label
(
EPA
Reg#:
464­
126,
at
an
application
rate
1­
3%)
it
is
not
clear
if
OPP
migrates
from
pallets
(
used
to
transfer
fruits
and
vegetables)
made
of
OPP­
treated
wood
migrates
into
fruits
and
vegetables.
The
Agency
recommends
that
industry
provide
residue
data
to
show
how
much
OPP
migrates
from
wood
products
into
food.

4.2.6
Paper
Adhesive
Use
FDA
has
provided
a
pre­
estimated
residue
value
of
7
ppb
for
OPP
when
it
is
used
as
a
paper
adhesive
in
food
packaging
materials.

There
is
no
acute
dietary
NOAEL,
and
hence
the
Agency
has
estimated
the
chronic
dietary
risks
for
use
scenarios
discussed
above
Estimated
EDIs,
DDD
and
%
cPAD
are
provided
in
the
Table
4­
11.

Table
4­
11
Cumulative
Estimated
Dietary
Intake
(
EDI)/
Daily
Dietary
Dose
(
DDD)
and
%
cPADs
for
OPP
from
INDIRECT
Food
uses
Use
Dietary
Concentration
(
ppb)
Estimated
Daily
Intake
(
µ
g/
person/
day
Daily
Dietary
Dose(
mg/
kg/
day)
%
cPAD
Counter
top/
disinfectant
280
840
(
adult)
420
(
child)
0.012
(
adult)
0.056
(
child)
3.0
14
Page
35
of
60
Dishwashing/
disinfectant
91.5
274
(
adult)
137.5
(
child)
0.004
(
adult)
0.0092
(
child)
1.0
2.0
Paper
slimicide
use
1120
3360
(
adult)
1680
(
child)
0.048
(
adult)
0.017
(
child)
12.0
4.0
Paper
Coating/
preservative
3200
9600
(
adult)
480
(
child)
0.014
(
adult)
0.032
(
child)
3.6
8.0
Paper
Adhesive
preservative
7
21
(
adult)
10.5
(
child)
0.0003
(
adult)
0.0007(
child)
0.08
0.17
Cumulative
4978
14935
9adult)
3148
(
child)
0.090
(
adult)
0.17
(
child)
20
29
4.3
DIETARY
EXPOSURE
ASSESSMENT
FOR
CONVENTIONAL
(
AGRICULTURAL)
PESTICIDES.

Tolerances
(
40
CFR
Part
180.129)
were
established
for
the
residues
of
orthophenylphenol
and
its
sodium
salt
(
FR
Notice
27938,
1981
and
its
amendment
FR
Notice
32015,
1983).
The
tolerances
were
established
for
the
fungicidal
post­
harvest
application
of
these
chemicals:
Raw
agricultural
commodities
(
RAC)
including:
apple,
cantaloupe,
carrot,
cherry,
citrus,
citron,
cucumber,
grapefruit,
kiwifruit,
kumquat,
lemon,
lime,
nectarine,
orange,
bell
pepper,
peach,
pear,
pineapple,
plum,
prune,
sweet
potato,
tangerine,
tomato.
The
established
tolerances
vary
from
125
ppm
(
high
end)
on
cantaloupe
to
5
ppm
(
cherry,
nectarine)
levels.

This
part
of
the
non­
cancer
dietary
risk
assessment
was
carried
out
by
OPP's
Health
Effects
Division
(
DP
Barcode:
D319639).
It
was
conducted
using
the
Dietary
Exposure
Evaluation
Model
(
DEEM­
FDIC
 
)
,
Version
2.03
as
well
as
Lifeline
Model
Version
3.0
which
uses
food
consumption
data
from
the
USDA's
Continuing
Surveys
of
Food
Intake
by
Individuals
(
CSFII)
from
1994­
1996
and
1998.
This
assessment
is
tier
1,
conservative
(
assumes
100%
crop
treatment)
and
uses
the
deterministic
approach.
As
input
parameters
for
modeling
analyses,
residue
level
tolerances
(
indicated
above)
were
used
as
point
estimates.
The
chronic
analyses
were
below
Agency's
level
of
concern
for
the
general
US
Population
(
7.1%
of
cPAD)
and
all
other
populations
subgroups
(
the
most
highly
exposed
being
children
1­
2
years
old
with
a
24.6%
of
the
cPAD)

Table
4­
12
summarizes
the
Dietary
Exposure
and
Risk
for
OPP/
NA­
OPP/
K­
OPP
based
on
DEEM­
FCID
 
and
Lifeline
Model
results.

Assumptions:
1)
To
the
established
pears
and
citrus
tolerances
(
40
CFR
180.29),
1
ppm
contribution
by
residues
of
OPP
on
mushrooms
was
added
and
DEEM­
FCID
was
run.
2)
Reference
dose
RfD,
Chronic
=
0.39
mg/
kg/
day.
There
are
no
dietary
concerns
due
to
this
additional
exposure
scenario.
Page
36
of
60
Table
4­
12
===============================================================================

Total
Exposure
by
Population
Subgroup
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­

Total
Exposure
­­­­­­­­­­­­­­­­­­
­­­­­­­­­­­­­­­­­
Population
mg/
kg
Percent
of
Subgroup
body
wt/
day
Rfd
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
­­­­­­­­­­­­­
­­­­­­­­­­­­­­­
U.
S.
Population
(
total)
0.027769
7.1%

U.
S.
Population
(
spring
season)
0.027756
7.1%

U.
S.
Population
(
summer
season)
0.025804
6.6%

U.
S.
Population
(
autumn
season)
0.027836
7.1%

U.
S.
Population
(
winter
season)
0.029815
7.6%

Northeast
region
0.036468
9.4%

Midwest
region
0.025900
6.6%

Southern
region
0.023917
6.1%

Western
region
0.028107
7.2%

Hispanics
0.036660
9.4%

Non­
hispanic
whites
0.025299
6.5%

Non­
hispanic
blacks
0.031023
8.0%

Non­
hisp/
non­
white/
non­
black
0.037770
9.7%

All
infants
(<
1
year)
0.037606
9.6%

Nursing
infants
0.020614
5.3%

Non­
nursing
infants
0.044057
11.3%

Children
1­
6
yrs
0.077565
19.9%

Children
7­
12
yrs
0.041654
10.7%

Females
13­
19
(
not
preg
or
nursing)
0.026256
6.7%

Females
20+
(
not
preg
or
nursing)
0.019846
5.1%

Females
13­
50
yrs
0.022823
5.9%

Females
13+
(
preg/
not
nursing)
0.025276
6.5%

Females
13+
(
nursing)
0.025877
6.6%

Males
13­
19
yrs
0.028211
7.2%
Page
37
of
60
Table
4­
13
Estimated
Chronic
Dietary
Exposure
and
Risk
from
use
of
Na­
OPP
as
an
inert
ingredient.

Population
Subgroup2
Generic
Estimated
Exposure1
(
mg/
kg/
day)
OPP/
salts
Estimated
Exposure3
(
mg/
kg/
day)
%
cPAD
U.
S.
Population
(
total)
0.120
0.0012
­
0.006
0.31%
­
1.5%
All
infants
(<
1
year)
0.245
0.0025
­
0.012
0.63%
­
3.1%
Children
(
1­
2
years)
0.422
0.0042
­
0.021
1.1%
­
5.4%
Children
(
3­
5
years)
0.310
0.0031
­
0.016
0.79%
­
4.0%
Children
(
6­
12
years)
0.174
0.0017
­
0.009
0.45%
­
2.2%
Youth
(
13­
19
years)
0.100
0.0010
­
0.005
0.26%
­
1.3%

Adults
(
20­
49
years)
0.087
0.0008
7
­
0.004
0.22%
­
1.1%

Adults
(
50+
years)
0.086
0.0008
6
­
0.004
0.22%
­
1.1%

Females
(
13­
49
years)
0.087
0.0008
7
­
0.004
0.22%
­
1.1%
1Exposure
estimates
are
based
on
highest­
tolerance­
level
residues
of
high­
use
active
ingredients
for
all
food
forms,
including
meat,
milk,
poultry,
and
eggs
2
Only
representative
population
subgroups
are
shown
3
Generic
exposures
based
on
application
rates
of
1
­
5
lb
ai/
acre
were
adjusted
for
the
tolerance
exemption
limitation
of
0.1%
maximum
formulation
and
maximum
application
rates
(
0.05
lb
inert/
acre);
the
generic
exposures
were
divided
by
a
factor
of
20
(
1/
0.05)
and
100
(
5/
0.05)
cPAD
=
0.39
mg/
kg/
day
5.0
AGGREGATE
RISK
ASSESSMENT
In
order
for
a
pesticide
registration
to
continue,
it
must
be
shown
"
that
there
is
reasonable
certainty
that
no
harm
will
result
from
aggregate
exposure
to
pesticide
chemical
residue,
including
all
anticipated
dietary
exposures
and
other
exposures
for
which
there
are
reliable
information."
Aggregate
exposure
is
the
total
exposure
to
a
single
chemical
(
or
its
residues)
that
may
occur
from
dietary
(
i.
e.,
food
and
drinking
water),
residential,
and
other
non­
occupational
sources,
and
from
all
known
or
plausible
exposure
routes
(
oral,
dermal,
and
inhalation).

In
performing
aggregate
exposure
and
risk
assessments,
the
Office
of
Pesticide
Programs
has
published
guidance
outlining
the
necessary
steps
to
perform
such
assessments
(
General
Principles
for
Performing
Aggregate
Exposure
and
Risk
Assessments,
November
28,
2001;
available
at
http://
www.
epa.
gov/
pesticides/
trac/
science/
aggregate.
pdf).
Steps
for
deciding
whether
to
perform
aggregate
exposure
and
risk
assessments
are
listed,
which
include:
identification
Page
38
of
60
of
toxicological
endpoints
for
each
exposure
route
and
duration;
identification
of
potential
exposures
for
each
pathway
(
food,
water,
and/
or
residential);
reconciliation
of
durations
and
pathways
of
exposure
with
durations
and
pathways
of
health
effects;
determination
of
which
possible
residential
exposure
scenarios
are
likely
to
occur
together
within
a
given
time
frame;
determination
of
magnitude
and
duration
of
exposure
for
all
exposure
combinations;
determination
of
the
appropriate
technique
(
deterministic
or
probabilistic)
for
exposure
assessment;
and
determination
of
the
appropriate
risk
metric
to
estimate
aggregate
risk
The
short­
term
dermal
toxicity
endpoint
for
OPP
was
based
on
skin
irritation
observed
in
a
21­
day
dermal
toxicity
study
in
rats.
In
comparison,
the
oral
and
inhalation
endpoints
are
based
on
systemic
effects
from
a
developmental
toxicity
study
in
rats.
Therefore,
the
short­
term
dermal
exposures
were
aggregated
in
a
separate
analysis
from
the
shortterm
inhalation
and
oral
exposures.
However,
for
intermediate­
term
oral,
dermal,
and
inhalation
exposures,
the
same
study
and
endpoint
was
used.
Therefore,
all
intermediateterm
exposures
were
aggregated
together
as
appropriate.

The
toxicological
endpoints
for
OPP
and
OPP
salts
are
assumed
to
be
identical.
The
target
MOEs
for
all
routes
of
exposures
for
all
durations
is
set
at
100
for
occupational
and
residential
scenarios.
Examination
of
product
labels,
showed
that
exposure
to
handlers
can
occur
in
a
number
of
and
residential
environments.
Post­
application
exposures
also
occur
in
these
settings.

5.1
Acute
and
Chronic
Dietary
Aggregate
Risk
In
general,
acute
and
chronic
dietary
aggregate
risks
are
represented
by
dietary
(
direct,
indirect,
and
inert
exposures)
and
drinking
water
exposures.
As
there
is
no
acute
dietary
endpoint
selected
for
OPP
and
drinking
water
exposure
is
not
of
concern,
an
acute
aggregate
dietary
assessment
is
not
performed
for
OPP.
Exposure
from
direct
food,
indirect
food,
and
inert
uses
for
OPP
have
been
assessed.
Exposure
from
direct
food
and
inert
uses
was
conducted
using
the
Dietary
Exposure
Evaluation
Model
software
with
the
Food
Commodity
Intake
Database
(
DEEM­
FCIDJ),
Version
2.00,
which
incorporates
consumption
data
from
USDA=
s
Continuing
Surveys
of
Food
Intakes
by
Individuals
(
CSFII),
1994­
1996
and
1998.
Exposures
from
indirect
food
uses
of
OPP
from
counter
top
disinfectants,
dishwashing
disinfectants,
paper
slimicides,
paper
coatings,
and
paper
adhesives
were
derived
from
FDA's
methodology.

Results
of
indirect
food
use
exposure
are
presented
in
Table
4­
11
while
results
of
direct
food
use
exposure
are
presented
in
Table
4­
12.
Results
of
dietary
exposure
from
the
inert
use
of
OPP
are
presented
in
Table
4­
13.
Total
aggregate
dietary
exposure
and
risk
is
shown
below
in
Table
5­
1
for
direct,
indirect,
and
inert
uses
of
OPP.
The
results
indicate
that
for
adults,
31.5%
of
the
cPAD
is
occupied
from
all
dietary
exposure
sources,
while
for
children,
68.7%
of
the
cPAd
is
occupied
from
all
dietary
sources.
These
percentages
are
below
100%
of
the
cPAD
and
are
thus
not
of
concern
to
the
Agency.
Page
39
of
60
Table
5­
1
Aggregate
Dietary
Exposures
and
Risks
(
direct,
indirect,
and
inert
uses)

Direct
Dietary
Exposure
(
mg/
kg/
day)
Indirect
Dietary
Exposure
(
mg/
kg/
day)
Population
Active
Active
Inert
cumulative
%
cPAD
Dose
(
mg/
kg/
day)
U.
S.
Population
0.027
0.090
0.006
31.5
Children
0.077
0.17
0.021
68.7
5.2
Short­
and
Intermediate­
Term
Aggregate
Risk
Short­
term
aggregate
exposures
and
risks
were
assessed
for
adults
and
children
that
could
be
exposed
to
OPP
and
OPP
salt
residues
from
the
use
of
products
in
nonoccupational
environments.
The
short­
term
dermal
toxicity
endpoint
(
NOAEL
of
100
mg/
kg/
day
from
a
21­
day
dermal
toxicity
study)
was
based
on
skin
irritation.
In
comparison,
the
short­
term
oral
and
inhalation
endpoints
were
based
on
systemic
effects
from
the
same
study
and
toxic
effect
(
NOAEL
of
100
mg/
kg/
day
from
developmental
toxicity
studies).
Therefore,
short­
term
dermal
exposures
were
aggregated
in
a
separate
analysis
from
the
short­
term
inhalation
and
oral
exposures.

For
OPP,
the
short­
term
aggregate
assessment
includes
average
(
chronic)
dietary
exposure
and
estimated
exposures
from
incidental
oral
and
inhalation
exposure
that
are
believed
to
co­
occur.
For
short­
term
aggregate
risk
to
adults,
the
average
dietary
exposure
was
aggregated
with
short­
term
oral
and
inhalation
exposures
that
occur
from
mopping,
wiping,
and
air
deodorizer
uses
the
short­
term
incidental
oral
and
inhalation
residential
exposures.
Dermal
aggregate
risk
is
assessed
separately
as
the
study
and
endpoint
used
for
risk
assessment
was
different
for
this
route
of
exposure.

Results
of
the
short­
term
dermal
aggregate
assessment
are
presented
in
Tables
5­
2a
and
5­
2b.
The
results
showed
no
aggregate
risks
of
concern
to
adults
applying
OPP
through
wiping,
mopping,
or
air
deodorizing
activities
(
total
MOE
=
333)
or
to
children
from
post­
application
exposures
(
MOE
=
355).

Table
5­
2a
Short­
term
Aggregate
Exposure
and
Risk
Assessment
for
Adults
Exposure
Routes
Exposure
(
mg/
kg/
day)
Margin
of
Exposure
Total
MOE
Dietary
aggregate
0.123
317
Inhalation
exposure
­
wiping
­
mopping
­
air
deodorizer
0.0157
0.0043
0.0001
6,300
23,000
670,000
333
Page
40
of
60
Inhalation
post­
app
Air
deodorozer
0.00026
370,000
a:
Aggregate
MOE
=
1/(
1/
MOEdiet)
+
(
1/
MOEwipe,
app­
inhal)
+
(
1/
MOEmop,
app­
inhal)
+
(
1/
MOEair
deodorizer,
app­
inhal)
+
(
1/
MOEair
deodorizer,
post­
inhal))

Table
5­
2b
Short­
term
Aggregate
Exposure
and
Risk
Assessment
for
Children
Exposure
Routes
Exposure
(
mg/
kg/
day)
Margin
of
Exposure
Total
MOE
Dietary
aggregate
0.115
339
Oral
exposure
­
mopping
0.0824
1200
Inhalation
post­
app
Air
deodorozer
0.00095
105,000
355
a:
Aggregate
MOE
=
1/(
1/
MOEdiet)
+
(
1/
MOEmop,
post­
app:
oral)
+
(
1/
MOEair
deodorizer,
post
app:
inhal))

Table
5­
3
presents
the
results
of
short­
term
dermal
aggregate
exposure
and
risk.
For
dermal
aggregate
exposures,
there
were
no
risks
of
concern
to
either
adults
or
children.

Table
5­
3
Short­
term
Aggregate
Dermal
Exposures
and
Risks
Exposure
Routes
Adults
Children
Exposure
(
mg/
kg/
day)
Margin
of
Exposure
Exposure
(
mg/
kg/
day)
Margin
of
Exposure
Wiping
0.672
150
0.674
150
mopping
0.129
780
N/
A
Air
deodorizer
0.0064
16,000
N/
A
Pet
product
(
inert
use)
0.00052
190,000
0.32
310
TOTAL
MOE
0.807
141
0.99
111
a:
Aggregate
MOE
=
1/((
1/
MOEwipe)
+
(
1/
MOEmop)
+
(
1/
MOEair
deodorizer))

Intermediate­
term
aggregate
risks
(
children
only)
are
presented
in
Table
5­
4.
The
intermediate­
term
toxicity
endpoints
for
all
of
the
routes
of
exposure
(
oral,
dermal
and
inhalation)
are
based
on
the
same
study
and
same
toxic
effect
(
NOAEL
of
39
mg/
kg/
day
from
a
chronic/
carcinogenicity
study);
therefore,
all
intermediate­
term
routes
were
aggregated
together
as
appropriate.
There
are
no
intermediate­
term
residential
scenarios
identified
for
adults.
For
children,
intermediate­
term
scenarios
were
identified
for
postapplication
oral,
inhalation,
and
dermal
exposures
from
household
cleaning.
Page
41
of
60
Intermediate­
term
aggregate
risk
(
children
only)
was
calculated
to
be
247.
This
value
are
above
the
target
MOE
of
100
and
is
thus
not
of
concern.

Table
5­
4
Intermediate­
term
Aggregate
Exposure
and
Risks
for
Children
Exposure
Routes
Exposure
Margin
of
Exposure
Dietary
aggregate
0.115
339
Post­
app
incidental
oral
from
mopping
0.0057
6800
Post­
app
dermal
from
mopping
0.0421
930
Incidental
Oral
pet
product
inert
use
0.0039
10,000
Inhalation
air
deodorizer
post­
app
0.00095
41,000
Total
0.167
247
a:
Aggregate
MOE
=
1/(
1/
MOEdiet)
+
(
1/
MOEinc.
oral
post­
app)
+
(
1/
MOEdermal
post­
app)
+
(
1/
MOE
inc.
oral
pet
product)
+
(
1/
MOE
inhalation
air
deodorizer)

The
exception
to
the
above
is
for
adult
and
child
dermal
post­
application
exposures
to
textile
OPP
residues
(
which
alone
are
of
concern
to
the
Agency),
and
which
were
not
included
into
the
aggregate
assessment
as
this
would
make
aggregate
risk
of
concern.
This
exposure
scenario
needs
to
be
addressed
in
order
to
make
exposure
from
this
use
of
OPP
not
of
concern.

6.0
CUMULATIVE
RISK
FQPA
(
1996)
stipulates
that
when
determining
the
safety
of
a
pesticide
chemical,
EPA
shall
base
its
assessment
of
the
risk
posed
by
the
chemical
on,
among
other
things,
available
information
concerning
the
cumulative
effects
to
human
health
that
may
result
from
dietary,
residential,
or
other
non­
occupational
exposure
to
other
substances
that
have
a
common
mechanism
of
toxicity.
The
reason
for
consideration
of
other
substances
is
due
to
the
possibility
that
low­
level
exposures
to
multiple
chemical
substances
that
cause
a
common
toxic
effect
by
a
common
mechanism
could
lead
to
the
same
adverse
health
effect
as
would
a
higher
level
of
exposure
to
any
of
the
other
substances
individually.
A
person
exposed
to
a
pesticide
at
a
level
that
is
considered
safe
may
in
fact
experience
harm
if
that
person
is
also
exposed
to
other
substances
that
cause
a
common
toxic
effect
by
a
mechanism
common
with
that
of
the
subject
pesticide,
even
if
the
individual
exposure
levels
to
the
other
substances
are
also
considered
safe.

AD
did
not
perform
a
cumulative
risk
assessment
as
part
of
this
RED
for
OPP
because
AD
has
not
yet
initiated
a
review
to
determine
if
there
are
any
other
chemical
substances
that
have
a
mechanism
of
toxicity
common
with
that
of
OPP.
For
purposes
of
this
RED,
EPA
has
assumed
that
OPP
does
not
have
a
common
mechanism
of
toxicity
with
other
substances.
Page
42
of
60
On
this
basis,
the
Registrant
must
submit,
upon
EPA's
request
and
according
to
a
schedule
determined
by
the
Agency,
such
information
as
the
Agency
directs
to
be
submitted
in
order
to
evaluate
issues
related
to
whether
orthophenylphenol
shares
a
common
mechanism
of
toxicity
with
any
other
substance
and,
if
so,
whether
any
tolerances
for
OPP
need
to
be
modified
or
revoked.
If
AD
identifies
other
substances
that
share
a
common
mechanism
of
toxicity
with
OPP,
AD
will
perform
aggregate
exposure
assessments
on
each
chemical,
and
will
begin
to
conduct
a
cumulative
risk
assessment.

The
Health
Effects
Division,
Office
of
Pesticide
Programs,
has
recently
developed
a
framework
proposed
for
conducting
cumulative
risk
assessments
on
substances
that
have
a
common
mechanism
of
toxicity.
This
guidance
was
issued
for
public
comment
on
January
16,
2002
(
67
FR
2210­
2214)
and
is
available
from
the
OPP
Website
at:
http://
www.
epa.
gov/
pesticides/
trac/
science/
cumulative_
guidance.
pdf.
In
the
guidance,
it
is
stated
that
a
cumulative
risk
assessment
of
substances
that
cause
a
common
toxic
effect
by
a
common
mechanism
will
not
be
conducted
until
an
aggregate
exposure
assessment
of
each
substance
has
been
completed.

Before
undertaking
a
cumulative
risk
assessment,
AD
will
follow
procedures
for
identifying
chemicals
that
have
a
common
mechanism
of
toxicity
as
set
forth
in
the
AGuidance
for
Identifying
Pesticide
Chemicals
and
Other
Substances
that
Have
a
Common
Mechanism
of
Toxicity@
(
64
FR
5795­
5796,
February
5,
1999).

7.0
OCCUPATIONAL
EXPOSURE
AND
RISK
A
complete
explanation
of
the
occupational
exposure
and
risk
assessment
can
be
found
in
the
supporting
disciplinary
chapter
entitled
Occupational
and
Residential
Exposure
Chapter
for
Orthophenylphenol
&
Orthophenylphenol
Salts
(
D320537).
Summary
information
is
provided
in
this
section.

The
occupational
handler
scenarios
were
assessed
to
determine
dermal
and
inhalation
exposures.
The
general
assumptions
and
equations
that
were
used
to
calculate
occupational
handler
risks
are
provided
in
the
section
of
the
occupational
and
residential
exposure
chapter
entitled
Criteria
for
Conducting
the
Risk
Assessment.
The
majority
of
the
scenarios
were
assessed
using
CMA
data
and
Equations.
However,
for
the
occupational
scenarios
in
which
CMA
data
were
insufficient,
other
data
and
methods
were
applied.

For
the
majority
of
the
occupational
handler
scenarios
assessed,
MOEs
in
the
occupational
setting
were
above
the
target
MOE
of
100
for
dermal,
inhalation
and
total
exposures,
except
for
the
following
scenarios:

 
Agricultural
premises,
fogging:
intermediate­
term
PPE
Total
MOE
=
98
 
Commercial/
Institutional
premises,
wiping:
short­
term
baseline
dermal
MOE=
74,
intermediate­
term
baseline
dermal
MOE
=
68,
and
intermediate­
term
baseline
Total
MOE
=
64.
Page
43
of
60
 
Medical
premises,
mopping:
short­
term
baseline
dermal
MOE=
93,
intermediate­
term
baseline
dermal
MOE
=
84,
and
intermediate­
term
baseline
Total
MOE
=
78.
 
Materials
Preservatives,
liquid
pour
preservation
of
textiles:
short­
term
PPE
dermal
MOE=
92,
intermediate­
term
PPE
dermal
MOE
=
83,
and
intermediate­
term
Total
MOE
=
78.
 
Materials
Preservatives,
painter
(
applying
paint
post­
preservation),
airless
sprayer:
baseline
dermal
short­
term
MOE
=
66.
 
Using
EPA's
Wall
Paint
Exposure
Model
(
WPEM),
an
inhalation
MOE
of
43
was
calculated
for
professional
painters
breathing
the
vapor
of
OPP.

All
of
the
occupational
inhalation
MOEs
were
above
the
target
MOE
of
100,
except
for
the
following
scenario:

Agricultural
equipment,
fogger
IT
inhalation
MOE
=
880
7.1
Occupational
Post­
application
Exposures
Occupational
post­
application
exposures
were
assessed
for
inhalation
from
fogging
use
and
dermal
and
inhalation
from
metalworking
fluid
use.
In
addition,
the
potential
for
inhalation
exposures
to
the
vapor
of
OPP
may
occur
to
bystanders
as
a
result
of
material
preservative
applications
in
industrial
settings.
Currently,
no
data
are
available
to
assess
these
bystander
exposures
and
therefore,
monitoring
data
are
needed.

7.1.1
Fogging
Inhalation
exposures
were
assessed
for
entry
into
a
building
which
has
gone
through
a
fogging
application;
it
is
assumed
that
dermal
post­
application
exposure
is
negligible.
The
inhalation
exposure
assessment
was
conducted
using
the
Multi­
Chamber
Concentration
and
Exposure
Model
(
MCCEM
v1.2).
Based
on
the
MCCEM
.
csv
output,
MOE
values
were
calculated.
Both
the
short­
term
MOE
(
690)
and
the
intermediate­
term
MOE
(
270)
were
above
the
target
MOE
of
100
but
below
1,000.
Therefore,
the
Agency
may
request
that
a
confirmatory
inhalation
toxicity
study
be
submitted
since
the
current
inhalation
endpoint
is
based
on
an
oral
toxicity
study.

7.1.2
Metalworking
Fluids:
Machinist
There
is
a
potential
for
dermal
and
inhalation
exposure
when
a
worker
handles
treated
metalworking
fluids.
This
route
of
exposure
occurs
after
the
chemical
has
been
incorporated
into
the
metalworking
fluid
and
a
machinist
is
using/
handling
this
treated
end­
product.

For
dermal
exposures,
a
short­,
intermediate­,
and
long­
term
exposure
estimate
were
derived
using
the
2­
hand
immersion
model
from
ChemSTEER.
The
dermal
MOE
value
calculated
is
above
the
target
MOE
of
100
for
intermediate­
and
long­
term
dermal
exposures
(
MOE
=
290).
However,
there
is
concern
with
short
term
dermal
exposure
Page
44
of
60
because
the
calculated
MOE
of
54
is
below
the
target
MOE
of
100.
It
should
be
noted
that
the
short­
term
end
point
is
based
on
the
dermal
irritation
and
therefore,
a
higher
film
thickness
value
was
used
in
comparison
to
the
intermediate­
term
and
long­
term
exposures.

For
inhalation
exposures,
a
screening­
level
intermediate
and
long
term
inhalation
exposure
estimate
for
treated
metalworking
fluids
has
been
developed
using
the
OSHA
PEL
for
oil
mist.
The
inhalation
MOE
values
for
IT/
LT
and
ST
exposures
to
OPP
and
OPP
salts
are
all
above
the
target
MOE
of
100
(
IT/
LT
MOE
=
3,600
and
ST
MOE
=
9,300).

7.2
Wood
Preservation
OPP
and
OPP
salts
are
used
in
products
that
are
intended
to
preserve
wood
(
non­
pressure
treated
wood).
As
noted
on
label
Reg
#
67869­
24,
OPP
Salt
for
wood
preservation
serves
the
purpose,
"
for
the
temporary
protection
of
freshly
sawn
lumber
against
staining
and
molding.
[
The
product]
are
applied
to
the
freshly
sawn
lumber
by
either
dipping
or
spraying."

Handler
and
post
application
scenarios
that
have
been
identified
for
wood
preservation
were
extracted
from
MRID
455243­
04,
"
Measurement
and
Assessment
of
Dermal
and
Inhalation
Exposures
to
Didecyl
Dimethyl
Ammonium
Chloride
(
DDAC)
Used
in
the
Protection
of
Cut
Lumber
(
Phase
III)"
(
Bestari
et
al.,
1999).
This
proprietary
study
includes
the
potential
ways
that
an
individual
can
come
into
contact
with
preserved
wood.

CMA
unit
exposure
data
were
used
to
assess
exposure
to
the
composite
wood
blender/
spray
operators.
The
liquid
pump
preservative
unit
exposures
for
gloved
workers
were
used
in
this
assessment.
The
dermal
UE
was
0.00629
mg/
lb
ai
and
the
inhalation
UE
was
0.000403
mg/
lb
ai.
These
values
are
based
on
two
replicates
where
the
test
subjects
were
wearing
a
single
layer
of
clothing
and
chemical
resistant
gloves.
The
quantity
of
the
wood
being
treated
was
derived
from
other
wood
preservative
estimates
for
the
amount
of
wood
slurry
treated
because
no
chemical
specific
data
were
available
for
OPP.

Calculation
of
short­,
and
intermediate
term
and
IT
total
MOEs
for
the
workers
adding
the
preservative
to
the
wood
slurry
showed
that
all
of
the
MOEs
were
above
the
target
MOE
of
100
and
therefore
do
not
pose
a
concern.
However,
the
IT
inhalation
MOE
(
840)
for
the
blender/
spray
operators
adding
the
chemical
via
closed­
liquid
pumping
is
less
than
1,000
and
therefore
a
confirmatory
inhalation
toxicity
study
is
warranted
based
on
these
results.

For
dip
tank
operators,
the
exposure
assessment
was
conducted
differently
than
for
the
other
job
functions.
This
was
because
concentrations
of
DDAC
in
the
diptanks
were
known.
Calculation
of
dermal
and
inhalation
MOEs
as
well
as
total
intermediate
term
MOEs
showed
that
all
were
above
the
target
MOE
of
100.
Page
45
of
60
CMA
data
were
inadequate
to
represent
the
other
job
functions
associated
with
preservation
on
non­
pressure
treated
wood
(
e.
g.,
chemical
operators,
trim
saw
operators,
millwrights,
cleanup
crews,
and
construction
workers).
As
very
little
chemical
specific
data
were
available
regarding
typical
exposures
to
OPP
as
a
wood
preservative,
surrogate
data
were
used
to
estimate
exposure
and
risks.
Inhalation
and
dermal
exposures
associated
with
wood
preservation
were
assessed
using
surrogate
data
from
a
study
review
Measurement
and
Assessment
of
Dermal
and
Inhalation
Exposures
to
Didecyl
Dimethyl
Ammonium
Chloride
(
DDAC)
Used
in
the
Protection
of
Cut
Lumber
(
Phase
III)
(
Bestari
et
al.,
1999).
This
study
is
proprietary;
therefore,
data
compensation
needs
to
be
paid
for
use
of
the
data
in
this
exposure
assessment.
It
was
assumed
that
the
workers
at
facilities
using
OPP
and
OPP
salt
preservatives
are
performing
similar
tasks
as
those
monitored
in
the
DDAC
study.

Calculation
of
short­
and
intermediate­
term
dermal
and
inhalation
MOEs
for
these
other
job
functions
(
chemical
operators,
trim
saw
operators,
millwrights,
cleanup
crews,
and
construction
workers)
showed
all
MOEs
above
the
target
level
of
100.
In
addition,
the
total
intermediate
term
MOEs
were
also
above
the
target
level
of
100
for
the
entire
list
of
job
functions.

7.3
Summary
of
Registered
Conventional
(
Agricultural)
Uses
7.3.1
Occupational
Handler
Exposure
Scenarios
OPP
and
NA­
OPP
are
used
as
a
conventional
post­
harvest
fungicide
for
citrus
and
pears.
Application
rates
range
from
0.0066
to
0.19
lb
ai/
gallon
solution
(
0.05
to
2%).
Treatment
rates
range
from
3,000­
10,000
lbs
fruit/
gallon
of
solution
depending
on
the
concentration
of
ai.
For
example,
the
RTU
thermo­
fogging
product
has
an
application
rate
of
0.0633
lb
ai/
2200
lbs
fruit.
It
is
to
be
noted
that
in
the
absence
of
actual
chemical
specific
data,
the
Agency
utilizes
data
from
the
Pesticide
Handler
Exposure
Database
(
PHED),
Version
1.1
to
assess
handler
exposures.
The
potential
exists
for
dermal
and/
or
inhalation
exposure
during
the
following
occupational
handler
scenarios:

 
M/
L
liquid
concentrate
solutions
for
post­
harvest
foaming,
dipping,
drenching,
brushing,
spraying
treatments;
 
Loading
RTU
solutions
for
post­
harvest
foaming,
dipping,
drenching,
brushing,
spraying
treatments;
 
Loading
RTU
solution
for
thermo­
fogging
post­
harvest
treatment
using
an
XEDA
®
Electrofogger;
significant
dermal
and
inhalation
exposures
are
not
expected
for
thermo­
fogging
applications
 
workers
are
not
present
within
the
storage
rooms
during
the
application
process;
 
Application
of
solutions
by
foaming,
dipping,
drenching,
brushing,
spraying.
Note:
this
scenario
is
not
a
typical
"
applicator"
scenario.
The
assessment
for
automated
application
estimates
exposures
and
risks
(
inhalation
exposure
only
 
automated
application
process
results
in
negligible
dermal
exposure)
for
workers
in
the
vicinity
of
the
application
process.
Page
46
of
60
A
study
designed
to
evaluate
potential
postapplication
exposures
of
workers
to
NAOPP
OPP
during
post­
harvest
pear
and
citrus
fruit
handling
activities
was
conducted
by
Dow
Chemical
to
fulfill
a
portion
of
the
data
requirements
requested
by
the
Agency
in
a
Data
Call­
In
(
DCI)
in
1992.
A
protocol
of
the
study
was
reviewed
and
comments
and
recommendations
were
made
by
HED
(
Morris,
1993
.
The
submitted
study
(
MRID
43432901),
completed
in
1994,
is
titled
"
Evaluation
of
Postapplication
Exposures
to
Sodium
o­
Phenlyphenate
Tetrahydrate/
o­
Phenylphenol
to
Workers
During
Post­
Harvest
Activities
at
Pear
and
Citrus
Fruit
Packaging
Facilities."

The
study,
mainly
designed
to
evaluate
postapplication
activities
(
i.
e.,
sorters
and
packers),
included
area
(
i.
e.,
background)
air
monitoring
data.
It
is
assumed
that
this
data
captured
NA­
OPP/
OPP
air
concentrations
during
the
automated
application
process
and
will
be
used
to
quantitatively
assess
inhalation
risk
for
process­
area
workers
during
this
process
(
dermal
exposure
during
the
automated
application
process
is
considered
negligible).
It
should
be
noted
that
the
stated
intention
of
the
area
monitoring
was
not
for
quantitative
assessment
of
inhalation
exposures
during
application.
It
was
determined,
however,
that
this
data,
although
mostly
collected
in
the
sorting/
packing
areas,
provided
a
reasonable
representation
of
inhalation
exposure
for
workers
in
the
vicinity
of
the
operation
during
the
application
process.

With
the
use
of
chemical­
resistant
gloves
(
i.
e.,
baseline/
gloves
PPE),
short­
term
dermal
risks
are
not
of
concern
for
handlers.
Short­
term
inhalation
risks
are
not
of
concern
at
baseline
PPE
(
i.
e.,
no
respiratory
protection).
Intermediate­/
long­
term
dermal
risks
are
not
of
concern
when
chemical­
resistant
gloves
are
used
and
intermediate­/
long­
term
inhalation
risks
are
not
of
concern
at
baseline
PPE.
Tables
7­
1
and
7­
2
below
summarize
the
handler
risk
estimates.

Table
7­
1
Short­
term
Dermal
and
Inhalation
Risks
for
OPP,
and
salts
Handler
Activities
Short­
term
Risk
Dermal
MOE
(
Target
MOE
=
100)
Inhalation
MOE
(
Target
MOE
=
100*)
Exposure
Scenario
Crop
Application
Rate
(
lb
ai/
lb
fruit)
Baseline
Baseline/
Gloves
Baseline
Mixing/
Loading
&
Loading
Mixing/
loading
EC/
SC
for
Automated
Post­
harvest
Applications
Citrus
&
Pears
0.0000633
26
3300
64000
Loading
RTU
for
Automated
Postharvest
Applications
Citrus
only
0.0000133
130
16000
300000
Loading
RTU
for
Thermofogging
applications
Pears
only
0.0000288
58
7300
140000
Automated
Application
Process
Page
47
of
60
Citrus
&
Pears
Activities
during
automated
application
(
i.
e.,
operations
monitoring)
Citrus
only
NA
Negligible
6100
Table
7­
2
Intermediate­/
Long­
term
Dermal
and
Inhalation
Risks
for
OPP,
and
salts
Handler
Activities
Intermediate­/
Long­
term
Risk
Dermal
MOE
(
Target
MOE
=
100)
Inhalation
MOE
(
Target
MOE
=
100*)
Exposure
Scenario
Crop
Application
Rate
(
lb
ai/
lb
fruit)
Baseline
Baseline/
Gloves
Baseline
Mixing/
Loading
&
Loading
Mixing/
loading
EC/
SC
for
Automated
Post­
harvest
Applications
Citrus
&
Pears
0.0000633
24
3000
25000
Loading
RTU
for
Automated
Postharvest
Applications
Citrus
only
0.0000133
110
14000
120000
Loading
RTU
for
Thermofogging
applications
Pears
only
0.0000288
53
6700
55000
Automated
Application
Process
Citrus
&
Pears
Activities
during
automated
application
(
i.
e.,
operations
monitoring)
Citrus
only
NA
Negligible
2400
7.3.2
Occupational
Postapplication
Exposure
and
Risk
Assessment
In
the
case
of
NA­
OPP/
OPP
post­
harvest
commodity
applications,
workers
performing
sorting
and
packing
activities
are
potentially
exposed
to
NA­
OPP/
OPP
following
application.
Additionally,
potential
dermal
and
inhalation
exposures
exist
for
storage
room
re­
entry
workers
following
thermo­
fogging
applications
performing
post­
treatment
residue
sampling
and
for
workers
transporting
treated
pears
from
the
storage
room
to
be
processed
and/
or
distributed.

Although
the
label
specifying
use
with
the
XEDA
®
Electrofogger
requires
users
to
follow
the
machine's
operator
instructions,
which,
in
turn,
directs
re­
entry
workers
to
wear
SCBA
when
oxygen
levels
are
low,
it
is
recommended
that
this
provision
be
directly
referenced
on
the
label
for
workers
re­
entering
the
storage
room
to
collect
residue
samples
or
perform
other
early
re­
entry
activities.
Page
48
of
60
It
is
recommended
that
sorters
(
including
pre­
sorters)
and
packers
of
citrus
fruits
and
pears
wear
chemical­
resistant
gloves
with
baseline
PPE
(
i.
e.,
long­
sleeve
shirt
and
pants).
It
was
noted
in
the
study
that
sorters/
packers
typically
wear
short­
sleeve
shirts,
so
chemical­
resistant
gloves
with
arm
extensions
(
instead
of
a
long­
sleeve
shirt)
may
be
more
appropriate.
The
incident
reports,
OPP/
NA­
OPP's
classifications
as
Category
I
and
II
acute
dermal
irritants,
respectively,
and
the
absence
of
acute
toxicity
data
warrant
use
of
this
additional
PPE.
Currently,
some
labels
require
handlers
to
wear
baseline
PPE
with
chemical­
resistant
gloves
and
goggles
or
a
faceshield.

Table
7­
3
below
summarizes
the
postapplication
risk
estimates
for
citrus
and
pear
facilities.
Short­
term
risk
calculations
are
shown
using
both
the
arithmetic
mean
and
maximum
reported
exposures;
intermediate­/
long­
term
risks
are
calculated
using
the
arithmetic
mean
only.
Additionally,
all
dermal
risk
estimates
are
calculated
with
exposures
adjusted
for
the
maximum
labeled
application
rate
(
2%
solution).

Table
7­
3
Postapplication
Risk
Estimates
for
Sorters
and
Packers
in
Citrus
Fruit
and
Pear
Facilities
Short­
term
Risk
(
Target
MOE
=
100)
Intermediate­/
Long­
term
Risk
(
Target
MOE
=
100*)

Dermal
MOE
Inhalation
MOE
Dermal
MOE
Inhalation
MOE
Postapplication
Activity
Crop
(
State)

Mean
Max
Mean
Max
Mean
Mean
Citrus
(
FL)
240
150
20000
11000
220
7900
Pre­
sorting
Citrus
(
CA)
870
580
5900
2800
790
2300
Pears
(
WA)
120
51
5800
3600
110
2200
Citrus
(
FL)
770
550
28000
18000
700
11000
Sorting
Citrus
(
CA)
2200
880
72000
20000
2000
28000
Pears
(
WA)
190
130
7300
5700
170
2800
Citrus
(
FL)
1300
620
120000
100000
1100
47000
Packing
Citrus
(
CA)
5500
2400
81000
33000
5000
32000
8.0
ENVIRONMENTAL
RISK
8.1
Ecological
Hazard
Page
49
of
60
2­
phenylphenol
and
its
salts
demonstrate
low
toxicity
to
birds,
and
moderate
toxicity
to
mammals,
freshwater
fish,
freshwater
invertebrates,
and
algae.

The
low
exposure
potential
from
the
indoor
uses
of
2­
phenylphenol
and
salts,
coupled
with
the
tendency
for
the
compounds
to
degrade
under
environmental
conditions,
result
in
low
likelihood
of
adverse
acute
effects
to
wildlife
and
aquatic
organisms
from
the
indoor
uses.
Risk
from
the
antisapstain
used
has
been
assessed
on
a
screening
level.

Laboratory
studies
indicate
that
2­
phenylphenol
demonstrates
some
potential
to
act
as
an
endocrine
disruptor.
When
the
appropriate
screening
and/
or
testing
protocols
being
considered
under
the
Agency's
Endocrine
Disruptor
Screening
and
Testing
Advisory
Committee
(
EDSTAC)'
s
Endocrine
Disruptor
Screening
Program
(
EDSP)
have
been
developed,
2­
phenylphenol
may
be
subjected
to
additional
screening
and/
or
testing
to
better
characterize
effects
related
to
endocrine
disruption.

8.2
Environmental
fate
and
Transport
Orthophenylphenol
is
stable
and
persistent
in
abiotic
aqueous
medium
at
pHs
5,
7
and
9.
When
exposed
to
sunlight
in
neutral
aqueous
medium,
it
degrades
with
a
half
life
of
14
days.
Photolytically,
therefore,
it
is
not
stable.
Exposure
to
uv
light
(
at
253.7
nm),
results
in
the
degradation
products:
phenyl
benzoquinone,
phenylhydroquinone,
and
2­
hydroxy
benzofuran.
Its
half
life
in
air
is
14
hours
(
measured
against
the
reaction
with
hydroxyl
radical).
OPP
in
its
vapor
form
in
the
air
is
unstable
and
not
persistent.
It
is
immobile
in
soils
with
a
KOC
value
of
10,000.
Ground
water
contamination
does
not
seem
likely.
The
major
degradation
route
appears
to
be
through
biodegradation
in
aerobic
and
anaerobic
environments.
The
observed
half­
life
values
vary
from
three
hours
to
three
week,
depending
on
the
exposure
sites
(
holding
pond
to
open
river
etc.)
When
wood
is
treated
for
antisapstain
use,
NA­
OPP
leaches
up
to
58%
the
first
day
after
application
(
highest
application
rate
for
NA­
OPP
is
4%).
After
day
14,
86%
of
NA­
OPP
leaches
out
from
the
treated
wood.

8.3
Environmental
Exposure
and
Risk
Most
uses
of
2­
phenylphenol
are
considered
to
be
indoor
uses.
The
discharge
of
any
effluents
which
might
contain
2­
phenylphenol
residues
is
regulated
by
the
NPDES
program;
facilities
discharging
any
such
effluents
are
required
to
have
an
NPDES
permit
prior
to
discharging
effluents
into
receiving
waters.
EPA/
ORD/
NRML's
Treatability
Database
shows
that
wastewater
treatment
technologies
have
95%
removal
efficiency
for
phenolic
compounds.
This,
coupled
with
2­
phenylphenol's
tendency
to
degrade
under
aerobic
and
anaerobic
conditions
in
the
environment,
indicates
that
environmental
exposure
from
the
indoor
uses
of
2­
phenylphenol
is
likely
to
be
low.

Based
on
the
results
of
the
antisapstain
modeling,
runoff
from
antisapstain
treating
facilities
will
exceed
acute
high
risk,
restricted
use,
and
endangered
species
LOCs
for
freshwater
fish,
freshwater
invertebrates,
and
aquatic
plants.
Chronic
risks
cannot
be
assessed
at
this
time
due
to
a
lack
of
chronic
toxicity
data.
Page
50
of
60
The
model
used
to
estimate
exposure
from
antisapstain
uses
is
intended
as
a
Tier
I
screening
model,
and,
as
such,
has
inherent
assumptions
and
uncertainties
that
may
result
in
over­
or
under­
estimation
of
exposure
levels.
Since
the
model
is
only
intended
as
a
screening­
level
model,
further
refinement
of
the
model
is
recommended
to
more
accurately
assess
risks
from
the
antisapstain
uses
of
2­
phenylphenol.

Methods
to
reduce
the
amount
of
2­
phenylphenol
potentially
released
from
antisapstaintreated
wood
could
potentially
mitigate
the
risks.
Possible
mitigation
methods
might
include,
but
are
not
limited
to,
lowering
the
application
rate
or
requiring
specific
storage
conditions
to
prevent
exposure
of
recently
treated
wood
to
weather
(
e.
g.,
full
covering)
and/
or
prevent
the
release
of
any
associated
runoff
into
aquatic
habitats
(
e.
g.,
drip
pads).
2­
phenylphenol
is
not
very
mobile
in
soils,
so
any
2­
phenylphenol
leached
outdoors
will
likely
bind
to
soils
and
not
reach
aquatic
habitats
as
free
2­
phenylphenol.

8.4
Endangered
Species
Consideration
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
CFR.
'
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
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
Page
51
of
60
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
Ano
effect@
determination.
The
active
ingredient
uses
of
2­
phenylphenol,
with
the
exception
of
the
antisapstain
wood
preservation
use,
fall
into
this
category.
Using
Tier
I
screening
modeling
to
assess
potential
exposure
from
antisapstain
wood
preservation
uses
of
2­
phenylphenol,
risks
to
Listed
Species
are
indicated.
Since
the
model
is
only
intended
as
a
screening­
level
model,
and,
as
such,
has
inherent
uncertainties
and
limitations
which
may
result
in
inaccurate
exposure
estimations,
further
refinement
of
the
model
is
recommended
before
any
regulatory
action
is
taken
regarding
the
antisapstain
uses
of
2­
phenylphenol.
Additionally,
impacts
from
the
antisapstain
use
could
potentially
be
mitigated
with
precautions
to
prevent
leaching
and
runoff
when
wood
is
stored
outdoors
(
see
Label
Hazard
Statements/
Use
Recommendations,
below).
Due
to
these
circumstances,
the
Agency
defers
making
a
determination
for
the
antisapstain
uses
of
2­
phenylphenol
until
additional
data
and
modeling
refinements
are
available.
At
that
time,
the
environmental
exposure
assessment
of
the
antisapstain
use
of
2­
phenylphenol
will
be
revised,
and
the
risks
to
Listed
Species
will
be
reconsidered.

9.0
INCIDENT
REPORT
ASSESSMENT
OPP
and
its
sodium
and
potassium
salts
are
used
fungicides
and
disinfectants.
OPP
is
known
to
be
a
skin
and
mucous
membrane
irritant.
NA­
OPP
and
K­
OPP
are
known
for
their
corrosivity.
We
have
used
two
approaches
to
determine
the
potential
health
effects
of
incidences
on
humans
by
OPP,
NA­
OPP
and
K­
OPP.
1)
Gather
and
analyze
the
incidence
reports
obtained
from
different
sources;
2)
A
Literature
search
of
chronic
health
effects
associated
with
OPP/
NA­
OPP/
K­
OPP
exposure,
including
results
from
epidemiological
studies,
if
any.

The
Following
databases
were
consulted
for
poisoning
incidence
data
on
OPP:
1)
Office
of
Pesticides
Programs
(
OPP)
Incident
Data
System
(
IDS)
2)
Poison
Control
Centers
3)
California
Department
of
Pesticide
Regulations
4)
National
Pesticide
Telecommunications
Network
(
NTPT)
5)
Published
Scientific
Literature
on
Incidences
9.1
OPP's
Incident
Data
System
(
IDS)

A
total
of
72
individual
human
incident
cases
submitted
to
EPA's
OPP
are
associated
with
exposure
to
products
containing
OPP/
NA­
OPP
and
K­
OPP.
These
products
are
used
as
surface
disinfectants
and
are
registered
by
a
number
of
registrants.
Most
of
the
reported
incidences
were
not
of
serious
nature.
Reported
incidents
were
for
humans
and
animals.
The
observed
symptoms
were:
burning
eyes,
itchy
skin,
difficulty
in
breathing,
coughing,
nausea,
vomiting,
hives,
headache,
swollen
mouth,
dizziness,
burning
throat,
erythema,
ulceration
of
foot,
nasal
irritation,
corneal
abrasion,
vertigo,
muscle,
weakness,
Page
52
of
60
diarrhea,
ocular
irritation,
nose
bleed,
dyspnea,
and
tremor.
These
symptoms
occurred
by
individuals
through
dermal
and
respiratory
exposure,
usually
from
a
spray.
The
symptoms
usually
cleared
after
a
few
minutes
or
a
few
hours.
No
severe
symptoms
or
death
occurred
from
exposure
to
this
chemical.

9.2
Poison
Control
Center
A
total
of
22,
318
incident
cases
have
been
reported
associated
with
exposure
to
phenolic
disinfectants.
These
incident
reports
were
recorded
between
1993
through
1998
by
the
American
Association
of
Poison
Control
Centers
(
PCC)
and
Toxic
Exposure
Surveillance
System
(
TESS)
between
the
years
of
1993­
through
1998.
None
of
these
reported
incident
relate
to
OPP
or
NA­
OPP
or
K­
OPP.
Most
of
the
incidences
(
>
93%)
were
associated
with
no
effects
to
only
minor
effects.
It
was
concluded
that
the
remaining
3
%
incidents
were
not
related
to
the
chemical
exposures.
Of
the
total
cases
reported,
only
eleven
were
considered
to
have
severe
clinical
effects.
Death
occurred
in
one
case.
The
primary
symptoms
in
the
major
incidences
were:
GI
tract
effect,
neurotoxic
signs,
cardiovascular
effects
and
respiratory
effects.

9.3
California
Data­
1982­
through
2003.

The
California
database
does
not
record
any
OPP,
NA­
OPP
or
K­
OPP
related
incidence.
A
total
of
360
cases
recorded
possibly
related
to
phenolic
disinfectants
use
and
these
were
submitted
to
the
California
Pesticide
Illness
Surveillance
Program.
The
database
presents
the
types
of
illnesses
for
each
year,
total
number
of
workers
that
took
time
off
as
a
result
of
their
illness
and
how
many
were
hospitalized
and
for
how
long.

9.4
National
Pesticide
Telecommunications
Network
(
NPTN)

There
are
no
incidences
reported
in
the
NPTN
database
related
to
OPP,
NA­
OPP
or
KOPP

9.5
Hazardous
Substances
Data
Bank
(
HSDB)

HSDB
indicates
that
a
fatal
dose
of
10.0
g
reported
and
toxic
effects
on
urothelium
of
the
bladder
were
observed
in
two
humans
due
to
orthophenylphenol
poisoning.

A
second
incident
report
in
the
scientific
literature
is
with
Microban
(
0.21
%
OPP,
0.69
%
diisobutylpehnoxy­
ethoxyethyldimethyl
ammonium
chloride,
and
0.04%
bromine).
Symptoms
observed
were:
primary
skin
and
mucous
irritation,
and
these
were
elevated
on
Monday
and
Tuesday,
but
the
symptoms
normalized
by
the
end
of
the
week.
It
was
not
obvious
which
one
component
caused
the
symptoms
or
if
it
was
a
combined
effect
of
the
three.
Page
53
of
60
9.6
Conclusions
OPP
and
salts
appear
to
cause
dermal
effects,
which
is
perhaps
due
to
irritation.
Inhalation
is
another
route
which
shows
some
symptoms
as
indicated
above.
However,
it
is
clear
that
all
the
databases
and
published
literature
show
that
specific
chemical
toxic
effects
can
not
be
attributed
specifically
to
OPP
or
NA­
OPP
or
K­
OPP
only,
as
most
of
the
symptoms
appear
in
a
mixture
of
active
ingredients,
one
of
them
OPP
or
its
salts.
Page
54
of
60
10.0
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